cyrilzakka/clinical-trials huggingface dataset:
Bioequivalence Study of Cephalexin Suspension 250

The objective of this study was to confirm if two formulations of cephalexin suspension are bioequivalent.

Test product was Ceporex® (250 mg Cephalexin / 5 ml; GlaxoSmithKline) and reference product Keflex® (125 mg Cephalexin / 5 ml; Eli Lilly). The single dosage was 10 ml of suspension for Ceporex and 20 ml of suspension for Keflex® .

The study was prospective, open-label, randomized, crossover, single dose, with 02 treatments, 02 sequences and 02 periods, under fasting conditions.

The population was composed of 28 healthy volunteers, both genders, adults between 18-50 years.

The comparative bioavailability of the two formulations was evaluated based in statistical comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations in blood.


Eligibility Criteria:
Inclusion Criteria:

Free will participation according to Mexican regulation, Helsinki Declaration, and Good Clinical Practice.

Healthy, between 18 and 50 years. Body Mass Index between 18 and 27.5 In good health by complete medical history and laboratory tests. Blood pressure 130-90/ 90-60 mm Hg; heart rate 55-100 beat per minute, respiratory rate 14-20 movements per minute.

Laboratory tests +/- 10% of normal interval (blood cytology, blood chemistry 27 elements, Hepatitis B and C antigens, HIV, urinalysis, anti-doping, pregnancy, electrocardiogram) -

Exclusion Criteria:

Alteration of vital signs Not complying with inclusion criteria History of cardiovascular, kidney, hepatic, muscular, metabolic, gastrointestinal (including constipation), neurologic, endocrine, hematopoietic (any kind of anemia), asthma, mental or organic disease. Those suffering from muscular trauma 21 days before the beginning of the study.

Requirement of any kind of medication during the course of the study, except study medication.

History of dyspepsia, gastritis, esophagitis, duodenal or gastric ulcer. Exposure to medications known as inducers or inhibitors of hepatic enzymes or administration of potentially toxic medication in the 30 days before the study beginning.

Administration of any medication in the 7 half-lives previous to the beginning of the study.

Hospitalization for any cause in the two months before the beginning of the study.

Administration of investigational drugs in the 60 days before the study. Allergy to any medication, food or substance. Alcohol ingestion or intake of beverages containing xanthines (coffee, tea, cocoa, chocolate, mate, cola drinks) or ingestion of charcoal grilled food or grapefruit or orange juice in the 72 hours before the hospitalization or tobacco smoking in the 72 hours before the beginning of the study.

Blood donation or loss =\> 450 ml in the 60 days before the beginning of the study.

History of drug or alcohol abuse. Special diet requirement, for instance vegetarian diet. Inability to understand nature, aims, and possible consequences of the study. Evidence of non-cooperative attitude during the study. Positive antidoping or pregnancy test Breast-feeding. Females on hormonal treatment.

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GW873140 In Combination With Kaletra In HIV Infected Subjects

This study is a 96-week study designed to evaluate the safety and efficacy of GW873140 in combination with Kaletra in HIV infected, untreated subjects.

A Phase IIb, 96 week, randomized, open-label, multicenter, parallel group, repeat dose study to evaluate the safety, tolerability, pharmacokinetics and antiviral effect of different doses and regimens of GW873140 in combination with Kaletra (lopinavir and ritonavir) in HIV-1 infected antiretroviral therapy naive subjects

Eligibility Criteria:
Inclusion criteria:

* HIV infected, therapy-naive subjects.
* Females must be of either non-childbearing age, or have a negative pregnancy test.
* All subjects participating in this study should be counseled on the practice of safe sex using a proven double barrier method of contraception throughout the study.
* Screening lab result of plasma HIV-1 RNA greater than or equal to 50,000 copies/mL and CD4 cell count greater than or equal to 100 cells/mm3.
* Have CC Chemokine Receptor5-tropic (R5-tropic) or CC Chemokine Receptor5/CXC Chemokine Receptor4-tropic (R5/X4-tropic) virus based on viral tropism test at screening visit.
* Be treatment-naive, defined as less than or equal to 2 weeks of treatment with a protease inhibitor (PI) or an nucleoside reverse transcriptase inhibitor/nucleotide reverse transcriptase inhibitor (NRTI/ NtRTI), or less than or equal to 7 days of therapy with a non-nucleoside reverse transcriptase inhibitor (NNRTI).
* Prior treatment with any entry inhibitor, attachment inhibitor, or fusion inhibitor (experimental or approved) is not allowed.
* Be able to understand and follow with protocol requirements, instructions and protocol-stated restrictions.
* Signed and dated written informed consent prior to study entry.

Exclusion criteria:

* No detection of CXC Receptor4-tropic (X4-tropic) virus only, based on viral tropism test at screening.
* No active Class C AIDS-defining illness.
* No laboratory abnormalities at screen.
* No significant blood loss prior to study start.
* No pregnant or breastfeeding women.
* Additional qualifying criteria to be determined by the physician.
Patient-reported Outcomes in Preoperative Immunochemotherapy/Radiotherapy-treated Esophageal Cancer Patients

Preoperative Immune checkpoint inhibitors combined with chemotherapy have revolutionized the treatment landscape of locally advanced esophageal squamous cell carcinoma. However, there are still a significant proportion of patients who could not benefit from such treatment modality. Currently, no effective biomarkers were identified to stratify responders and non-responders. Early dynamic and persistent relief of dysphagia may act as a predictive biomarker to reflect the on-treatment anti-tumor activity. In this prospective study, we aimed to explore the feasibility of using patient-reported outcomes (PROs) to predict the pathological complete response of esophageal squamous cell carcinoma patients treated with neoadjuvant immunochemotherapy with or without short-term radiation as well as to assess the efficacy and safety of short-term radiotherapy in PROs-insensitive patients after one cycle of neoadjuvant immunochemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed esophageal squamous cell carcinoma
* Potentially resectable esophageal squamous cell carcinoma at first diagnosis (cT1-4aN1-2M0, cT3-T4aN0M0)
* Treatment-naive
* Expected life span \> 6 months
* Aged 18 - 75 years old
* Adequate organ functions
* PS 0-2
* Participants are fully informed about the whole study and are willing to sign the informed consent

Exclusion Criteria:

* Previous history of thoracic surgery or radiation
* Cervical or multi-origin esophageal cancer
* Known or suspected experimental drug allergy
* Pregnant or lactating women
* Esophagomediastianl fistula
* Peripheral neuropathy
* Previous cancer history other than esophageal cancer
* Severe organ function deterioration that can not tolerate neoadjuvant therapy
* Previous autoimmune diseases
* diabetic history \> 10 years
* interstitial pulmonary disease, non-infectious pulmonitis
* Active type B hepatitis
* Any other conditions that may affect patients' safety and compliance
Study Use of PPSB-SD and VP-VI in Patients With Anticoagulant Therapy and Undergoing Acute CPB Surgery

The purpose of this study was to study the efficacy of PPSB-SD and VP-VI in patients, who received anticoagulant treatment and who had to undergo acute cardiac surgery with a cardiopulmonary bypass (CPB).

The value of oral anticoagulants such as coumarin derivatives as a therapy and in the prophylaxis of thrombosis is universally acknowledged. These medicinal products are used in the prevention of cerebral infarction, in patients with atrial fibrillation and in the secondary prevention of myocardial infarction. In case of elected surgery, the effect of coumarin derivatives can be reversed by a termination of the coumarin treatment and the administration of vitamin K orally, i.m. or i.v., which will restore the production of the vitamin K dependent coagulation factors. For patients due to undergo acute surgery, it will be unfavourable to await endogenous production of vitamin K dependent coagulation factor production.After CPB surgery, the patients need to be in a controlled coagulated state. Two products suitable to rapidly increase the concentration of vitamin K dependent coagulation factors, are fresh frozen plasma (FFP) and prothrombin complex concentrates (PCC). These products contain factor II, VII, IX and X and help to restore normal levels of the clotting fraction.Administration of these products prior to CPB surgery will decrease the INR to a level that is acceptable for surgery. In the Academic Hospital Leuven the standard procedure in cases of acute and elected CPB surgery is administration of VP-VI, a FFP-product made by OCTAPHARMA. In this study the standard treatment of 2x 400 ml VP-VI was compared with a treatment of PPSB Solvent Detergent® (PPSB-SD) according to the prescription regimen of CAF-DCF. PPSB-SD is a PCC product made by Sanquin Plasma Products (the Netherlands) for CAF-DCF (Belgium). The regimen as prescribed by CAF-DCF enables to calculate the quantity of PPSB-SD to administer on the basis of the patient's weight, the initial INR and the target INR. The expected outcome of the study was that in patients receiving PPSB-SD the target INR will be reached more frequently and more rapidly compared to patients receiving VP-VI.

Eligibility Criteria:
Inclusion Criteria:

age at least 18 years and due to undergo (semi-) acute cardiac surgery with a relatively stable haemodynamic condition.

and body weight less than 100 kg and informed consent and patients well controlled with acenocoumarol, phenprocoumon or warfarin.

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Exclusion Criteria:

patients with an overdose of acenocoumarol, phenprocoumon or warfarin (INR \> 7.8) and due to undergo (semi-) acute cardiac surgery hepatic insufficiency renal insufficiency anaphylactic reaction after administration of a blood product in the past disseminated intravascular coagulation (DIC) active thrombosis/pulmonary embolism intracardial thrombus patients treated with platelet inhibitors, except for aspirin (acetylsalicylic acid), who will be treated with aprotinine pregnancy breast-feeding

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Reverse Medical Barrel™ Device for Adjunctive Treatment for Wide-Neck, Intracranial, Bifurcating/Branching Aneurysms

Single arm study to evaluate the outcomes of treatment with the Barrel VRD device as an adjunctive treatment to coiling for wide neck, intracranial, bifurcating/branching aneurysms in the middle cerebral and basilar arteries.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female between 18 and 85 years old.
2. A wide-neck de novo or non-de novo aneurysm.
3. Appropriate informed consent obtainable as determined by local IRB.
4. Life expectancy \> 24 months.

Exclusion Criteria:

1. Aneurysm rupture within 30 days of enrollment.
2. Bifurcating aneurysms not treatable with coiling.
3. Subject has platelet count of \<70,000.
4. Subject has known allergies to nickel-titanium metal.
5. Subject has known allergies to aspirin or heparin.
6. Subject has a life-threatening allergy to contrast (unless treatment for allergy can be tolerated).
7. Subject is currently participating in another clinical research study.
8. Subject is pregnant or breastfeeding.
9. Subject has participated in a drug study within the last 30 days.
10. Subject is unable or unwilling to comply with protocol requirements and obtain required clinical evaluations and follow-up.
GEnomic Medicine in Kidney Transplantation Study

Investigator led, prospective, observational cohort study to detect genomic features which can predict outcomes following kidney transplantation.

1. Determine non-HLA genomic mismatches between donor-recipient pairs which impact kidney allograft survival following transplantation
2. Derive polygenic risk scores on pre-transplant blood and/or kidney biopsy samples which predict kidney allograft dysfunction
3. Derive polygenic risk scores on post-transplant blood and/or kidney biopsy samples which predict kidney allograft dysfunction


Eligibility Criteria:
Inclusion Criteria: All participants included in the study must be age ≥ 18 years old at time of enrolment and

1. able to provide informed consent (interpreter permitted) for enrolment
2. consenting to longitudinal follow up (can withdraw post enrolment)
3. consenting to provide samples for biobanking, including blood, urine, faecal and/or kidney biopsy tissue (collected prospectively, separate to routine care)

Exclusion Criteria: Patients will be excluded from the study if they are

1. unable (or unwilling) to provide consent, or
2. have life-expectancy less than 6-months, or
3. have received a haematopoietic stem cell transplant in the past 5 years.
PSMA PET Scan and mpMRI for Prostate Cancer Detection

Prospective, randomized, phase 2 clinical trial to determine if PSMA PET imaging plus mpMRI improves detection of clinically significant prostate cancer as compared to mpMRI alone.

This a prospective, randomized, phase 2 clinical trial. We will enroll patients who underwent mpMRI of the prostate as part of their standard clinical care, have PI-RADS 4, or 5 lesion(s) on mpMRI, and are scheduled to undergo fusion guided prostate biopsy. Subjects that sign the consent form will be randomized to undergo DCFPyL PET/CT imaging or no PSMA PET imaging prior to the prostate biopsy. In the PSMA scan cohort, decision for biopsy targets will be made based on the combination of the findings of mpMRI and PSMA scans. In the no PSMA scan (control) group, the biopsy will be performed based on mpMRI findings. Each patient will undergo 12 core systematic biopsy as the standard of care. Two additional biopsies for each mpMRI and PSMA PET and overlap lesion will also performed.

Eligibility Criteria:
Inclusion Criteria:

* Patients with PI-RADS 4-5 lesion(s) on mpMRI and have elected to undergo a prostate biopsy
* Prostate mpMRI completed within 9 months prior to enrollment
* Patient capable of providing written informed consent
* Patient willing to be randomized to prostate mpMRI only vs prostate mpMRI + DCFPyL PET/CT

Exclusion Criteria:

* Less than 18 years-old at the time of radiotracer administration
* Medical condition, serious concurrent illness, or other extenuating circumstance that, in the opinion of the Investigator, may significantly interfere with study procedures or compliance.
* Creatinine clearance exceeding institutional requirements for prostate mpMRI
Respiratory Rate Measured by Pressure Variation During HFNC

Monitoring the respiratory rate is important during procedural sedation. Several methods of measuring the respiratory rate are available, but most are unreliable and the most reliable method (capnography) is not available during the use of High Flow Nasal Cannula (HFNC) oxygen. We hypothesize that measuring the pressure variation in the HFNC-circuit is a reliable method of measuring the respiratory rate.

An experimental study, using healthy volunteers that will breath in three guided respiratory rates, compares the measurements of respiratory rate by the pressure variation in the HFNC circuit with measurements of respiratory rate by an ECG-derived method and a manual count by an physician.

A secondary outcome will be the ability to measure the size of pressure difference, in order to determine its feasiblity to use it as a surrogate for tidal volume or respiratory effort.

The healthy volunteers will be administered HFNC-oxygen and will be instructed to breath normally, rapidly and slowly for 30 seconds. This will be done at two HFNC flow rates (35 L/min and 70 L/min) and with an open and a closed mouth. During these 30 seconds the respiratory rate will be measured by pressure variation in the HFNC circuit, ECG-derived impedance difference and a manual count by a physician.

This will lead to 12 conditions, depending on HFNC flow (35 and 70 L/min), open or closed mouth and respiratory rate (normally, rapidly, slowly). The measurements of the respiratory rates wil be compared per HFNC flow and per open or closed mouth.

A secondary outcome will be the ability to measure the size of pressure difference, in order to determine its feasiblity to use it as a surrogate for tidal volume or respiratory effort.

Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers

Exclusion Criteria:

* known neurodegenerative diseases
* Pregnancy
* Children (age \<18)
* Upper airway obstruction
Internet-Delivered Psychological Treatment for Cancer Survivors

Negative psychological effects of cancer are common, but cancer survivors are rarely offered structured psychological treatment. Internet-delivered treatments have shown some promise, but specific treatment components have not been empirically evaluated which means that it is not clear which therapies that should be prioritized. In this randomized factorial trial at Karolinska Institutet, Stockholm, Sweden, 400 cancer survivors with psychiatric symptoms are enrolled in variations on a 10-week therapist-guided online psychological treatment intended to address the negative psychological long-term effects of cancer. The aim is to determine the contribution of treatment components to the overall effect.


Eligibility Criteria:
Inclusion Criteria:

* Cancer survivor at least 0.5 years after main therapy
* Clinically significant anxiety or depression (Patient Health Questionnaire 9 \[PHQ-9\]≥10, or Generalized Anxiety Disorder 7 \[GAD-7\]≥8, or 9-item Fear of Cancer Recurrence Inventory \[FCRI-9\]≥16)
* At least 18 years old
* Resident of Region Stockholms, Västra Götalandsregionen, or Region Skåne, Sweden (listed and de facto)
* Sufficient technical knowledge and knowledge of the Swedish language to take part in a text-based online treatment
* Continuous access to an electronic device that can be used to access the study web platform

Exclusion Criteria:

* Recurrent thoughts of suicide, as based on clinical judgement aided by the structured interview and the self-report version of the Montgomery-Åsberg Depression Rating Scale (MADRS-S) item 9
* Severe medical condition (e.g., very poor prognosis, stage IV cancer), severe psychiatric disorder (e.g., psychotic disorder, bipolar disorder, or severely debilitating substance use disorder, severe depression), or medical treatment (e.g., chemotherapy, immunotherapy, radiotherapy) that makes the treatment unfeasible
* Other ongoing psychological treatment
* Continuous psychotropic medication not stable for the past 4 weeks, or not expected to remain stable during the treatment period
* Planned absence for more than one week of the intended treatment period
* No complete the pre-treatment assessment
PharmD Transitions of Care Program (PHARMD-TOC): A Community Pharmacy Transitions of Care Program

Many hospitals and medical groups have developed transitions of care (TOC) programs or procedures in an attempt to reduce hospital readmission and reutilization rates of patients discharged from the hospital. As healthcare's most accessible practitioners, Community Pharmacists have a unique opportunity to assist with reducing unnecessary hospital re-utilization (re-admissions and emergency department visits) after hospital discharge. The purpose of this study is to conduct and evaluate the implementation of a Community Pharmacy-based Transitions of Care (TOC) Program for high-risk post-discharge patients of PIH Health Hospital-Whittier (PIH). The primary objective will be to compare the proportion of patients with hospital re-utilization (readmission, observation status, ED visits) during 30-days post hospital discharge between patients randomly assigned to the PHARMD-TOC group vs. the historic rate at PIH. Secondary analyses will examine differences between groups and describe implementation details of the PHARMD-TOC model of patient care.


Eligibility Criteria:
Inclusion Criteria:

* - Admission LACE Score: in moderate range (5 to 9) And
* Taking high risk medication(s): anticoagulants, insulin, oral antiplatelet agents, oral hypoglycemic agents, opioid analgesics, digoxin Or Taking at least 5 medications AND have one of following: CHF, COPD, Asthma, Pneumonia, Diabetes, ESRD, Schizophrenia, Bi-Polar, Dizziness, History of Falls

And

* Medical or Surgical Unit patients
* Age \> 18 years
* Being discharged to home (with or without Home Health services)
* English and/or Spanish speaking
* Will have access to a telephone post-discharge
* Ability to give consent
* Patient admitted to hospital through the emergency department, as a direct admission or as a transfer, or as an elective surgery patient

Exclusion Criteria:

* - Patients with observation status
* Caremore Health Plan patients (Caremore has a separate post-discharge program)
* Patients discharged and followed up by the PIH Coumadin Clinic
* Patients discharged to Residential MD House Calls program
* Patients discharged to Skilled Nursing Facility
* Anyone with planned readmissions
* Obstetrics patients
* Hospice patients
* Oncology patients
* Anyone who does not meet provisions of protocol
* Anyone unwilling or unable to give consent for study procedures and data access
Inflammatory Bowel Disease(IBD)Database

This will be a comprehensive epidemiological, clinical, endoscopic and histological database for inflammatory bowel diseases patients in our medical center that will further provide clinical and basic investigations.

Inflammatory bowel diseases (IBD), which include Crohn's disease (CD), ulcerative colitis (UC), undefined IBD and pouchitis (in patients who required IPAA for their colitis) affects about two million people in the world. At this time there is no definitive cure and current treatment is aimed at managing the symptoms and inflammation that accompany these diseases. These diseases are predominantly chronic, and patients may experience various gastrointestinal symptoms depending on the location, nature, and extent of their disease. Both genetic and environmental factors play etiological roles. The overall goal of our research is to understand the etiology and course of these diseases in order to prevent and to manage cases more effectively. In order to do so we are aiming at building a comprehensive database that will include detailed clinical data conjoined with dedicated research information and collection of biological specimens that will target the gut epithelium immune system, the microbiota and specific genetic risk factors.

Eligibility Criteria:
Inclusion Criteria:

Diagnosis of IBD Regular treatment and follow up in Tel Aviv Sourasky medical center Fap (familial polyposis)patients after a large bowel resection, as controls Family members of IBD patients as controls Patients with Irritable Bowel Syndrome (IBS), as controls -

Exclusion Criteria:

pregnancy age\<18 years

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A 10-Week Efficacy and Safety Study for of Gabitril in the Treatment of Adults With Generalized Anxiety Disorder

The purpose of this study is to evaluate the safety and efficacy of an investigational anti-anxiety medication relative to placebo in patients with generalized anxiety disorder (GAD)


Eligibility Criteria:
Inclusion Criteria:

* Subjects 18 to 64 years of age (inclusive) will be eligible to participate if they satisfy the DSM-IV-TR criteria for GAD, as well as meeting the required screening and baseline visit scores for a series of psychiatric evaluations (i.e., HAM-A, HADS, MADRS and CGI-S).

Exclusion Criteria:

* Have been previously unresponsive to two or more adequate courses of pharmacological treatment for GAD
* Have been diagnosed with any other psychiatric Axis I disorder (except GAD) as a principal diagnosis within the past six months
* Have been diagnosed with any eating disorder within the past six months
* Have any history of OCD, psychotic disorder, bipolar disorder or antisocial personality disorder
* Have any history of alcohol or substance abuse within the past 3 months
* Have any history of seizures, including febrile seizures
* Have any history of head trauma associated with loss of consciousness within the past 15 years