cyrilzakka/clinical-trials huggingface dataset:
A Study of Aflibercept Administered in Combination With Pemetrexed and Cisplatin in Participants With Advanced Carcinoma

The purpose of the study was to determine whether the combination of aflibercept, pemetrexed and cisplatin is safe and effective in treating non-small cell lung cancer (NSCLC).

The study was conducted in two phases. In phase 1, patients with advanced cancer received different doses of aflibercept in combination with approved doses of pemetrexed and cisplatin. The objective of phase 1 was to determine the safest dose of the combined study medications. This dose was administered to patients with previously untreated NSCLC in phase 2. The phase 2 portion of the study determined if the combination is effective in treating NSCLC.

Eligibility Criteria:
Inclusion Criteria:

* Confirmation of cancer by biopsy (tissue sample)
* Phase 1: patients with advanced or metastatic disease that have failed conventional therapy
* Phase 2: patients with previously untreated NSCLC, excluding squamous cell histology and cavitating lesions
* Age ≥18 years
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Adequate renal, liver and bone marrow function.
* Negative pregnancy test (serum or urine) in females of childbearing potential within 7 days of the initial dose of aflibercept
* Ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
* Institutional Review Board (IRB) approved, signed and dated informed consent form

Exclusion Criteria:

* Prior treatment with study medications
* Untreated, symptomatic, or progressive Central Nervous System cancer and/or spinal cord compression. Patients with treated brain metastases must have been without symptoms for at least 3 months
* Surgery up to 4 weeks prior to the initial administration of aflibercept and/or incomplete wound healing
* Anti-VEGF therapy up to 4 weeks prior to the initial administration of aflibercept (for phase 1 only)
* Chemotherapy up to 4 weeks prior to the initial administration of aflibercept (for phase 1 only)
* Other investigational treatment up to 4 weeks prior to the initial administration of aflibercept
* Any of the following up to 6 months (24 weeks) prior to the initial administration of aflibercept:

  * Severe cardiovascular disease or event
  * Cerebrovascular accident, transient ischemic attack, or moderate to severe peripheral neuropathy
  * Erosive esophagitis or gastritis, infectious or inflammatory bowel disease, and diverticulitis
  * Deep vein thrombosis, pulmonary embolism, or other clotting event
  * Episode(s)of moderate to severe, continuous bleeding
* Breast-feeding or pregnancy
A Study to Compare the Macitentan-tadalafil Fixed Dose Combination Tablet Relative to the Concomitant Administration of the Reference Tablets of Macitentan and Tadalafil in Healthy Subjects

The primary objective of this study is to demonstrate that macitentan and tadalafil administered as a fixed combination is bioequivalent to both compounds given as separate tablets given at the same doses as in the fixed combination (i.e. whether the amounts of macitentan and tadalfil which reach the blood are comparable).


Eligibility Criteria:
Key Inclusion Criteria:

* Signed informed consent
* Male and female subjects aged between 18 and 55 years (inclusive) at screening
* Healthy on the basis of the physical examination, vital signs, 12-lead ECG, and laboratory tests performed at screening
* Women must have a negative serum pregnancy test at screening and a negative urine pregnancy test on Day-1 or must be of non-childbearing potential.
* Body mass index (BMI) of 18.0 to 30.0 kg/m2 (inclusive) at screening
* Systolic blood pressure 100-145 mmHg, diastolic blood pressure 50-90 mmHg, and pulse rate 45-90 bpm (inclusive)

Key Exclusion Criteria:

* Known hypersensitivity to any active substance or drugs of the same class, or any excipients of the drug formulation(s)
* History or clinical evidence of any disease and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism or excretion of the study treatment(s)
* Values of hepatic aminotransferase (alanine aminotransferase \[ALT\] and/or aspartate aminotransferase \[AST\]) \> 3 X upper limit of normal at screening
* Loss of vision in one eye because of non-arteritic anterior ischemic optic neuropathy
* Known hereditary degenerative retinal disorders, including retinitis pigmentosa
* Priapism and anatomical deformation of the penis
* Previous history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions
* Treatment with another investigational drug within 3 months prior to screening or participation in more than 4 investigational drug studies within 1 year prior to screening
* Excessive caffeine consumption, defined as \> or = 800 mg per day at screening.
* Nicotine intake (e.g., smoking, nicotine patch, nicotine chewing gum, or electronic cigarettes) within 3 months prior to screening and inability to refrain from nicotine intake from screening until end-of-study (EOS; washout period included)
* Previous treatment with any prescribed medications (including vaccines) or over the counter (OTC) medications within 3 weeks prior to first study treatment administration.
* Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
Ambulatory Surgery of Lower Extremity Varicose Vein

OBJECTIVE: To retrospectively analyze the results of ambulatory treatment on Taiwanese patients with primary varicosities of the lower extremities including the use of endovenous laser, phlebectomy, and sclerotherapy.

METHODS: We routinely used tumescent anesthesia and ultrasound-guided approaches for the application of endovenous laser. Vein access was achieved by either a percutaneous or stab wound. The laser power was usually 10 - 20 watts; laser treatment usually was begun from 4-10 cm below the saphenofemoral junction, and stopped around the knee, not over 10 cm below the knee. In the same operation, we used Mueller's phlebectomy and/or sclerotherapy if there were prominent branch varicosities. We instructed each patient to walk around immediately after the operation, to go home, and to come back 1-3 days later for follow-up. Ultrasound scan and venous function follow-up was scheduled at 1 month, 6 months, 12 months, and then annually.


Eligibility Criteria:
Inclusion Criteria:

* All patients with varicose veins who underwent endovenous laser treatment for GSV reflux in our hospital were reviewed

Exclusion Criteria:

* poor general health, inability to walk, active inflammation of varicose veins, deep venous occlusion disease, hypercoagulability, pregnancy and breast-feeding.
Multicenter Observational Study of PSC and IgG4-SC in China

The investigators aimed to collect demographic features and clinical outcomes in patients diagnosed with PSC and IgG4-SC by utilizing participants database from multiple medical centers across Mainland China. Cross-sectional studies will focus on characterizing clinical presentations and validating diagnostic and prognostic models on Chinese PSC and IgG4-SC patients.


Eligibility Criteria:
Inclusion Criteria:

* Age above 18 years old,
* Male or Female,
* Patients admitted in our medical centers which met the PSC criteria according to The European Association for the Study of the Liver Clinical Practice Guidelines "Management of cholestatic liver diseases" in 2009; or patients diagnosed with IgG4-SC which met initially using the Japan Pancreas Society criteria and confirmed using HISORt criteria.

Exclusion Criteria:

* Female subjects who is pregnant, breastfeeding or is considering being pregnant during the study;
* History of other malignancies, including hematological tumors, solid tumors except hepatobiliary system;
* History of infectious diseases, including hepatis A, B, C, E and tuberculosis.
Study of the Clinical Benefits of Different Formulations of Amphotericin B

This project intends to carry out a multi-center retrospective observational real-world study to understand the current status of amphotericin B use by formulation type, compare the differences in safety and efficacy of each formulation in domestic clinical application, provide real-world evidence for clinical drug selection, and provide evidence-based evidence in support of rational clinical drug use.

The researchers selected patients with amphotericin B use records discharged from five tertiary hospitals across the country from January 1, 2020 to the present, extracted data according to the inclusion and exclusion criteria, and divided them into experimental and control groups, in order to understand the current status of amphotericin B use in each preparation type, compare the differences in the safety and efficacy of the various preparations in the domestic clinical application, and provide real-world evidence of the choice of clinical medication.

Eligibility Criteria:
Inclusion Criteria:

1. Patients discharged from January 1, 2020 to the present;
2. Patients with a record of amphotericin B use.

Exclusion Criteria:

1.Key information missing from patient studies.
Reducing the Harmful Effects of Cannabis Use: Finding the Optimal CBD:THC Ratio

This study will recruit healthy volunteers who use cannabis infrequently. Each participant will attend the laboratory on five occasions: an initial visit to check that they are safe to join the study and four days of testing.

Participants will be administered, in a randomized order, vaporized cannabis containing one of four different ratios of CBD:THC (0:1, 1:1, 2:1, 3:1). The cannabis administration will follow a standardised inhalation procedure using a medical-grade vaporizer device.

Participants will complete a series of tasks measuring cognition, psychosis, anxiety and other subjective experiences.

The study will be carried out at the NIHR-Wellcome Trust Clinical Research Facility at King's College Hospital.


Eligibility Criteria:
Inclusion Criteria:

* Female and male volunteers aged 21-50
* Have used cannabis at least once
* Willing to provide written informed consent
* Willing to provide blood samples
* Fluent English speaker

Exclusion Criteria:

* Past or present major mental illness
* Past or present major physical illness
* Past or present substance use disorder
* Past or present use of anti-psychotic or anti-depressant medications
* First degree relative with psychotic disorder
* Currently taking psychotropic medication
* Positive urine drug screen at screening or experimental visits
* Use of alcohol 24h prior to experimental visit or tobacco on the day of experiment
* Pregnancy (current or planned) or lactation in women
* Significant abnormality detected during physical examination at screening visit
* Cannabis use (defined as days in which cannabis is used recreationally) more than once per week on average over the last 12 months
* Any past use of synthetic cannabinoids
* Score of 5 and above on the Fagerstrom Nicotine dependence questionnaire
* BMI classified as obese or underweight
* Taken part in any drug study within the last 30 days or taking part in another study over the course of the trial
* Known drug sensitivity/allergy towards cannabis or Lorazepam
Plasma Dipeptidyl-peptidase-4 Activities With No-reflow and Bleeding

Dipeptidyl-peptidase-4 (DPP4) is an important regulator of incretins and inflammation, and participates in the pathophysiological process of acute myocardial infarction (AMI). However clinical data of DPP4a in AMI patients is sparse. This study was to investigate the role of plasma DPP4 activity (DPP4a) in patients with ST-segment elevation myocardial infarction (STEMI) treated with percutaneous coronary intervention (PCI). This was a analysis of consecutive patients conducted at a tertiary referral center from January 2014 to October 2015. The investigators included 747 STEMI-patients, treated with PCI from January 2013 to October 2015. Blood samples were collected immediately at admission. The patients were divided into four groups according to DPP4a quartile.

ST-segment elevation myocardial infarction (STEMI) is an acute manifestation of coronary heart disease, remaining a frequent cause of death.A better understanding of risk factors and pathogenic mechanisms underlying STEMI may help improve the prognosis and life quality of these patients.Dipeptidyl peptidase 4 (DPP4) is an exopeptidase expressed on the surface of diverse cells, cleaving off amino-terminal dipeptides with either L-proline, L-alanine or serine at the penultimate position. As a cell surface protein, it participates in immune regulation, signal transduction and apoptosis. DPP4 also circulates as a soluble form in the plasma. Soluble DPP4 came from either membrane type clearance or secreted by cells like endothelial cells, with enzymatic activity. Plasma DPP4 activity (DPP4a) are elevated in several diseases, including type 2 diabetes, obesity, atherosclerosis and osteoporosis. Basic studies have showed that DPP4 inhibition leads improved survival and heart function after cardiac ischemia-reperfusion (I/R) injury, and this is partly due to activation of AKT (pAKT), pGSK3 and ANP pathways. Also inhibition of DPP4 can alleviate atherosclerosis and heart failure. Accordingly, one could hypothesize that high DPP4a may worsen myocardial I/R injury, causing poorer cardiovascular outcomes. However, no study has evaluated whether DPP4a is associated with adverse clinical outcomes in STEMI patients.

Eligibility Criteria:
Inclusion Criteria:

* a diagnosis of STEMI and needed PCI

Exclusion Criteria:

* patients with cancer
* patients who used DPP4 inhibitor
* patients who used GLP1 analogue
Efficacy & Safety of SCH 900435 in Schizophrenia (Study P06079)(WITHDRAWN)

The purpose of this study is to assess whether SCH 900435 (Org 25935) 16 mg twice daily is more effective than placebo in the treatment of patients with schizophrenia, using olanzapine 15 mg once daily as active control.


Eligibility Criteria:
Inclusion Criteria:

* Subjects eligible to participate:

  * present a substantial and recent exacerbation of schizophrenia
  * have responded positively to treatment with an antipsychotic other than clozapine in the past
  * are without adequate treatment for their symptoms, or willing and capable to stop concurrent medication, which appears inadequate to treat their condition, prior to participation

Exclusion Criteria:

* Schizoaffective disorder;
* single episode of schizophrenia in partial remission
* concomitant use of antidepressants, mood-stabilizers (including anticonvulsants) or long-acting sedatives
* substance abuse or dependence (excluding nicotine and caffeine)
* uncompensated medical illness (including clinically relevant eye disorder)
Comparison Open Lichtenstein Repair and Totally Extraperitoneal Herniorrhaphy

comparison of early and long term results of open lichtenstein repair and totally extraperitoneal herniorrhaphy for primary inguinal hernias.

Early results such as postoperative pain, operation time and long term results such as chronic pain and recurrence will be compared.

Eligibility Criteria:
Inclusion Criteria:

* inguinal hernia

Exclusion Criteria:

* recurrent hernia
Analysis of Metabolic State in Normal-weight and Overweight-obese After Lifestyle Improvement and/or Weight Loss

The aim of this study is to design and validate a test, METAHEALTH-TEST, based in gene expression analysis in blood cells, to quickly and easily analyse metabolic health. This test will be used to analyse metabolic improvement in overweight/obese individuals and in metabolically obese normal-weight (MONW) individuals after undergoing a weight loss intervention and/or an intervention for improvement in eating habits and lifestyle.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18-45 years
* Participants with no chronic disease (excluding those related to overweight/obesity)

Exclusion Criteria:

* Minors or older than 45 years
* Presence of a metabolic illness
* Intake of regular medication or drugs
* Precedents of alcohol or drug consumption
* Physic of psychic disability
Exercise in the Physiotherapy Management of Shoulder Impingement

The purpose of this trial is to investigate the effectiveness of an evidence based exercise program for shoulder impingement. Approximately 1% of adults consult their General Practitioner (GP) with shoulder pain each year, making it the third most common reason for musculoskeletal GP consultations in the UK. A further 50% of these patients are diagnosed with subacromial impingement syndrome (SAIS) (shoulder impingement syndrome) and commonly referred for physiotherapy treatment. This trial aims to compare the effectiveness of an evidence based exercise protocol with usual physiotherapy care.

Physiotherapy management of shoulder impingement frequently involves exercise, however there is little evidence underpinning exercise prescription and outcomes are poor. Few trials have investigated which muscles should be targeted and how they should be strengthened with respect to the mode, frequency, duration, intensity and progression. This is a randomized controlled trial(RCT) investigating the effectiveness of an evidence based exercise program for shoulder impingement. This research may have an impact on how physiotherapists provide exercise programs to patients with shoulder impingement.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be aged 18 years and older.
* Shoulder pain of at least 3/10 in severity that has been diagnosed by a consultant rheumatologist, orthopaedic surgeon or general practitioner within the past 12 months.
* Positive Hawkins-Kennedy test.
* Positive on testing either supraspinatus (empty can test) or infraspinatus (resisted external rotation in neutral).

Exclusion Criteria:

* Acute traumatic conditions.
* Evidence of rotator cuff tear (positive drop arm test) or any other shoulder joint pathology (e.g. adhesive capsulitis, labral tears).
* A history of fractures of the upper arm, shoulder or clavicle within the past two years.
* A history of dislocation of the shoulder within the previous two years.
* Postoperative conditions involving the upper arm, shoulder or clavicle.
* Inflammatory or systemic diseases.
* Current signs and symptoms of acute nerve root pain arising from the cervical or upper thoracic spine.
* Previous physiotherapy for the same condition involving an exercise regime.
* Previous corticosteroid injection of the affected shoulder within the past 6 months.
* Unwilling participant.
Retrospective Chart Review of Candida Fungemia

Background:

Candida can cause infections. The most common kind of Candida at clinics is C albicans. But other kinds have increased at clinics too. Researchers want to review the records of people who were in previous NIH studies who had Candida. They want to find out what risk factors are associaated with this infection.

Objective:

To study the factors that are associated with Candida fungemia to develop. The factors are clinical features, diagnoses, and previous antifungal therapy.

Eligibility:

People who were in prior NIH studies and had Candida

Design:

Researchers will review the records of 62 NIH participants. The records are from 2004 to 2017. They will look at data such as blood test results, diagnosis, and treatments.

Researchers will only reach out to participants if they get approval from a review board.

This research will probably not reveal data that would be important to participants health. But if it does, researchers will try to contact those participants.

Data will be stored in secure computers. They will be stored with a code that only the study team can link to a participant.

This protocol is a chart review of patients who had Candida species grown from blood cultures drawn at the National Institutes of Health. The study will involve only review of patient records and will not require new specimens or participant contact. The patients whose records will be reviewed in this protocol are/were enrolled on a number of different protocols related to their underlying disease(s). Principal investigators of each protocol have been contacted to request permission to conduct this study, and to verify that none of the original protocols or informed consent documents precludes such a review of clinical data.

Eligibility Criteria:
* The study will involve only review of patient records and will not require new specimens or participant contact. The patients whose records will be reviewed in this protocol are/were enrolled on a number of different protocols related to their underlying disease(s).
Rechallenge, Potential Drug Induced Liver Injury (Kaiser)

Drug re-administration or rechallenge should be avoided after drug-induced liver injury (DILI) to avoid recurrent and fatal injury. Rechallenge outcomes vary considerably by drug and patient subjects. In order to better predict these outcomes, the objective of this analysis is to assess clinical outcomes of positive drug rechallenge following possible drug-induced liver injury. Electronic medical records from Kaiser Permanente California (KPSC), a managed care organization, will be utilized to identify patients who experience possible drug-induced liver injury following exposure to medications associated with hepatotoxicity, and who are then rechallenged with the medication.


Eligibility Criteria:
Inclusion Criteria:

* Patients who received at least one prescription for a suspect drug between Jan 1, 2003 and June 30, 2009 (drug initiation period)
* Patients who experienced incident DILI event (identified by ALT ≥3xULN or AP ≥2xULN within 6 months of suspect drug administration) during the first exposure period that:

  1. Resolved to within normal limits of ALT (for hepatocellular \& mixed) or AP (for cholestatic) within 180 days or
  2. Resolved to ALT \< 3xULN (for hepatocellular \& mixed) within 90 days or AP\<2xULN (for cholestatic) within 180 days or
  3. Dropped by ≥50% of (Peak ALT - ULN) for hepatocellular or of (Peak AP - ULN) for cholestatic or mixed within 180 days
* Patients who were rechallenged with the same suspect drug; rechallenge will include first rechallenge event for the analysis.
* Patients who had at least of 12 months of continuous membership and drug benefit prior to and on the dispensing index date (inclusive). There is no minimum restriction of continuous membership plus drug benefit after the start date.
* Patients who were 18 years of age or older at the time of the first drug dispensing (index date) during the drug initiation period Jan 1, 2003 and June 30, 2009. Each patient's first prescription for the study drugs during the drug initiation period will be identified as index prescription.
* Patients who had health insurance coverage with full medical, pharmacy and lab benefits at the index date.

Exclusion Criteria:

* Patients meeting the definition of chronic liver injury and exhibiting persistent ALT≥3xULN or AP or bilirubin ≥2xULN within 90 days after initial injury
* Patients with chronic liver injury diagnostic codes or included in KPSC disease registries preceding the initial or rechallenge liver injury