cyrilzakka/clinical-trials huggingface dataset:
Hycamtin Plus Carboplatin Versus Established Regimens for the Treatment of Ovarian Cancer Relapse

Determination of progression free survival after 12 months of FU

Determination of total survival, response and quality of life

In Germany there are two established therapy regimes for platin sensitive ovarian cancer: the combination of carboplatin and paclitaxel as well as the combination of carboplatin with gemcitabine. Choice of therapy is individual due to missing randomized comparisons between the regimes. Topotecan has shown good efficacy in second-line therapy of ovarian cancer as well as a good, especially, non-hematoxic toxicity profile. Several phase II-studies have demonstrated a synergistic effect of topotecan in combination with carboplatin exhibiting good efficacy and tolerability.

It shall be tested in this randomized phase III-study if the combination of topotecan and carboplatin shows improvement of progression-free survival in comparison to the standard regimes.

Eligibility Criteria:
Inclusion Criteria:

* Women ≥18 years of age with platinum-sensitive recurrent ovarian cancer occurring at least six months after completion of primary standard therapy are eligible
* Patients with measurable or assessable lesions or CA-125 ≥ 2x ULN an Eastern Co-operative Oncology Group (ECOG) performance status ≤ 2
* All patients will provide written informed consent

Exclusion Criteria:

* Patients with more than two chemotherapies in their history
* Progress less than six months after completion of primary standard therapy
* Simultaneous or planned radiation
* Any known hypersensitivity to topotecan, carboplatin, paclitaxel or gemcitabine
* Patients with infection
* Patients who are pregnant or breast feeding
An Adaptive Intervention for Adolescents at Risk for Suicide: A Pilot SMART

To inform the development of a technology-augmented adaptive intervention for adolescents at risk for suicide, the goal of this study is to conduct a Sequential, Multiple Assignment, Randomized Trial (SMART) pilot of a Motivational Interview (MI)-enhanced safety planning intervention (MI-SafeCope). Findings from this study will provide the groundwork for the construction of a technology-augmented adaptive intervention that could lead to a reduction in suicidal behaviors and related events during the high-risk post-discharge period-an important suicide prevention target.


Eligibility Criteria:
Inclusion Criteria:

* Suicide attempt (previous month), and/or
* Suicidal ideation (previous week)

Exclusion Criteria:

* Severe cognitive impairment or altered mental status (psychosis, manic state)
* Transfer to medical unit or residential placement
* No availability of a legal guardian
* No cell phone with text messaging capability
Investigation on Safety, Tolerability and Pharmacokinetics of Multiple Doses of NNC0113-0987 in an Oral Formulation in Healthy Subjects

This trial is conducted in Europe. The aim of the trial is to investigate safety, tolerability and pharmacokinetics (the exposure of the trial drug in the body) of multiple doses of NNC0113-0987 in an oral formulation in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Male subject, who is considered to be generally healthy, based on the medical history, physical examination, and the results of vital signs, electrocardiogram and laboratory safety tests performed during the screening visit, as judged by the investigator
* Age 18-64 years (both inclusive) at the time of signing informed consent
* Body mass index (BMI): 20.0-29.9 kg/m\^2 (both inclusive)

Exclusion Criteria:

* History of, or presence of, cancer, diabetes or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological,dermatological, venereal, neurological, psychiatric diseases or other major disorders, as judged by the investigator
* Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
* History of chronic pancreatitis or idiopathic acute pancreatitis
* Subject with previous gastrointestinal surgery, except subjects that underwent uncomplicated surgical procedures such as appendectomy, hernia surgery, biopsies, as well as colonic and gastric endoscopy
* Use of prescription or non-prescription medicinal products and herbal products (except routine vitamins) within three weeks preceding the dosing period. Occasional use of paracetamol or acetylsalicylic acid is permitted
Comparison of Pain Relief and Peripheral Perfusion Index

The primary endpoint of this study is to compare the pain relief and peripheral perfusion index using different volume of local anesthetics in erector spinae plane block.

The erector spinae plane block (ESPB) is a less invasive, safer, and technically easy alternative procedure to conventional neuraxial anesthetic techniques. In contrast to common neuraxial techniques such as paravertebral and epidural injections, the ESPB targets an interfascial plane which is far from the spinal cord, root, and pleura. First applied to thoracic neuropathic pain, currently ESPB is being applied to postoperative pain control and includes variable clinical situations. In the abdomen and thoracic wall, thoracic ESPB can be applied for pain control after cardiac surgery, video-assisted thoracic surgery, laparoscopic cholecystectomy, and thoracotomy. Recently, favorable postoperative pain control after lumbar spinal or lower limb surgeries has been reported with lumbar ESPB. In addition, ESPB has also been used for chronic pain conditions in the upper and lower extremities. To investigate the possible mechanism of action of the ESPB, many previous studies have focused on examining the physical spread of the injected agent. Commonly, contrast dye injections in human cadavers have been utilized to assess the spread level. Physical spread level was determined using various methods including direct dissection or sectioning, computed tomography (CT), thoracoscopic inspection, or magnetic resonance imaging (MRI) with radiocontrast injection. Apart from human cadaver studies, physical spread level has been evaluated in alive patients using a variable volume of local anesthetics mixed with radiocontrast. Perfusion index is an indirect method which can present the degree of peripheral perfusion. Moreover, it is known as a more sensitive measurement tool than the rise of skin temperature. The apply of perfusion index is very simple and noninvasive. The degree of PI increase has been used to determine the success of peripheral nerve block. The volume of local anesthetics has been used 10-30 ml. However, most effective dosage with proper pain relief has never been suggested.

Eligibility Criteria:
Inclusion Criteria:

* lumbar disc herniation
* lumbar foraminal stenosis
* lumbar central stenosis
* lumbar spondylolisthesis
* numerical rating scale \> 4
* back pain functional scale \< 45
* duration of pain \> 1 mon
* patients who can fully understand all items described in back pain functional scale

Exclusion Criteria:

* Allergy to local anesthetics or contrast medium
* Pregnancy
* Spine deformity
* Prior history of lumbar spine surgery
* No previous lumbar MRI or CT
* Patients with coagulation abnormality
All-Case Surveillance of Prizbind®

To evaluate safety and effectiveness of Prizbind® for Intravenous Solution 2.5 g under Japanese clinical condition.


Eligibility Criteria:
Inclusion criteria:

Patients who are prescribed with Prizbind® for Intravenous Solution 2.5 g by the discretion of investigators

Exclusion criteria:

None
Effect of Neprilysin on Glucagon-Like Peptide-1 in Patients With Type 2 Diabetes

Glucagon-like peptide-1(GLP-1) is secreted during a meal and increases glucose induced insulin secretion. The enzyme dipeptidyl peptidase 4(DPP-4) cleaves intact GLP-1 within minutes and DPP-4 inhibitors are therefore used for treatment of diabetic hyperglycemia. A few animal studies have implicated the enzyme neutral endopeptidase 24.11 (24.11) in the degradation of GLP-1 but if this is the case in humans with type 2 diabetes is unknown.

We therefore administered a NEP inhibitor, 194mg sacubitril, a DPP-4 inhibitor (sitagliptin 100mg the night before and 100mg 2 hours before), both, or placebo, to patients with type 2 diabetes during a standardized meal and measured plasma concentrations of GLP-1


Eligibility Criteria:
Inclusion Criteria:

* Type 2 Diabetes
* Oral Antidiabetics Medicine Only
* Body Mass Index of 25-35
* Type 2 Diabetes

Exclusion Criteria:

* acute diseases within the two weeks
* chronic diseases
* smoker
* alcoholism, drug addiction or recent weight loss
* blood donation within the last 3 months
Validation of Promising Biomarker Assays to Assess Their Diagnostic Performance Characteristics

This project aims to evaluate the performance characteristics of rapid tests to differentiate bacterial from non-bacterial infection in febrile adults and children presenting at OPDs (outpatient departments) i.e.("fever triage assays") in three LMICs. The evaluation will include a different commercial biomarker combinations as well as individual biomarkers to assess their individual or combined value in the target population. Markers will be evaluated onsite in ELISA or RDT format, as appropriate. Further, this study aims to contribute to a centralized biobank of well-characterized specimens for use by IVD companies and academic institutions for the development and evaluation of emerging assays.


Eligibility Criteria:
Inclusion Criteria:

Any non-severely ill subject presenting with acute fever defined as: temperature of more than 38°C at initial evaluation of less than 7 days of symptoms at presentation.

Inclusion criteria:

* Children 2-17 years of age
* Adults 18-65 years of age
* Signed written informed consent for study participation. For recruitment purposes, subjects will be classified into two groups, children and adults. For children, age \>2 years is the minimum cut-off, based on the amount of blood volume to be obtained in the study. WHO guidelines for allowable blood volume in 24 hours recommend that no more than 1-5% of total blood volume (75-80 ml/kg for older children) be obtained. Applying the average weight of a 2 year old toddler =12 kg, the allowable blood volume to be drawn in 24 hours at 1-5% of the total blood volume is 9.6 - 48 mL .

For minors, caregivers will provide informed consent. Documented assent for children of 12 to 16 years of age will be required for their participation.

Exclusion Criteria:

* Subjects who are felt to be in critical condition (based on clinician assessment or the presence of any general signs of critical illness as defined by WHO guidelines (for children: extensive vomiting, active seizure or recent history of seizures, altered mentation, inability to feed, or any of the severe IMNCI classifications; for adults: impending airway obstruction, central cyanosis, severe respiratory distress, feeble pulse, active seizure or recent history of seizures, or unconsciousness) because the target population for the study is non-severe febrile subjects.
* Subjects can only be enrolled once into the study.
BMS-354825 in Patients With Chronic Accelerated, or Blast Phase Chronic Myelogenous Leukemia or Philadelphia Positive Acute Lymphoblastic Leukemia

The purpose of this clinical research study is to understand the safety and efficacy of BMS-354825 in patients with chronic, accelerated, or blast phase chronic myelogenous leukemia (CML) or Philadelphia positive acute lymphoblastic leukemia (ALL) who are resistant to or intolerant of imatinib mesylate (Gleevec).


Eligibility Criteria:
Inclusion Criteria:

* Patients with Philadelphia chromosome positive, chronic, accelerated or blast phase BML or ALL.
* Patients must have primary or acquired hematologic resistance to imatinib mesylate or have intolerance of imatinib mesylate.
* Men and women, 14 years of age or older.
* Adequate renal function.
* Adequate hepatic function.
* Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for a period of at least 1 month before and at least 3 months after the study in such a manner that the risk of pregnancy is minimized.

Exclusion Criteria:

* Patients who are eligible and willing to undergo transplantation during the screening period.
* Women who are pregnant or breastfeeding.
* A serious uncontrolled medical disorder or active infection that would impair the ability of the subject to receive protocol therapy.
* Uncontrolled or significant cardiovascular disease.
* Medications that increase bleeding risk.
* Medications that change heart rhythms.
* Dementia or altered mental status that would prohibit the understanding of rendering of informed consent.
* History of significant bleeding disorder or unrelated to CML.
* Evidence of organ dysfunction or digestive dysfunction that would prevent administration of study therapy.
* Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness must not be enrolled into this study.
Evaluation of the Atlas Genetics io® CTNG System

Atlas Genetics io® system results are compared with those obtained from comparator devices.

Results from the Atlas Genetics io® system are compared with a Composite Infection Status obtained from testing on three commonly used comparator devices.

This is a prospective, single-arm, multi-centre investigation enrolling up to 12,000 adult participants over 14 years of age who are undergoing testing for the presence of CT/NG.

Eligibility Criteria:
Inclusion Criteria:

1. Symptomatic and asymptomatic individuals ≥14 years of age

Exclusion Criteria:

1. Treatment with antibiotics known to be effective against Chlamydia trachomatis and/or Neisseria gonorrhoeae within the previous 4 weeks before inclusion in the study.
2. Unable to self-obtain a vaginal swab or urine sample of at least 30 mL
Biopsy Incisional With Trepan in Periocular Lesions

The purpose of this study was to identify accuracy rates of 2mm punch biopsy technique in diagnosing periocular malignancy.

In each case, the histology obtained at biopsy was compared with that identified at the time of tumor excision.

Eligibility Criteria:
Inclusion Criteria:

* All lesions were initially examined at the slitlamp, after which lesions with malignant characteristics such as texture, size or color alterations asociated with ulceration, prominent borders or elevated contours, irregular borders, telangiectasias or loss of eyelashes were included.

Exclusion Criteria:

* Lesions with not malignant characteristics
GB001 in Adult Participants With Chronic Rhinosinusitis

A Phase 2a, randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy, safety, pharmacokinetics (PK), and pharmacodynamics (PD) of GB001 compared with placebo over 16 weeks of treatment in patients with chronic rhinosinusitis with or without nasal polyposis (NP).


Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of chronic rhinosinusitis with nasal polyps (CRSwNP) or chronic rhinosinusitis without nasal polyps (CRSsNP) by a physician at least 12 weeks before Screening Visit
* Treated with stable intranasal corticosteroid (INCS) for at least 2 months prior to Screening Visit
* Presence of at least 2 nasal symptoms: nasal blockage/ obstruction/congestion or nasal discharge or facial pain/pressure or reduction/loss of smell
* Women of childbearing potential must use an acceptable method of contraception

Exclusion Criteria:

* Sino-Nasal Outcome Test-22 (SNOT-22) score \< 20 at screening
* Asthma or chronic obstructive pulmonary disease (COPD) patients that are current smokers
* Use of other investigational drugs within 30 days, or within 5 half-lives, whichever is longer, prior to Screening Visit
* Pregnant or breastfeeding
* Pre-existing clinically important co-morbidities
* Regular use of systemic corticosteroids or immunosuppressive treatments

Other protocol-defined inclusion/exclusion criteria will apply.
Trial of Weight Bearing Status Following Femoral Revision With Tapered, Fluted, Titanium Stems

This is a prospective, randomized controlled trial of all patients undergoing femoral revision at Thomas Jefferson University Hospital and Rothman Institute undergoing femoral revision surgery with the use of a modern titanium, fluted, tapered stem. At the time of surgery, patients will be randomized to six weeks of toe-touch weight bearing or immediate weight bearing as tolerated


Eligibility Criteria:
Inclusion Criteria:

* femoral revision patients with the use of a modern titanium, fluted, tapered stem.

Exclusion Criteria:

* include cemented fixation of the stem and patients with a tenuous acetabular reconstruction for whom the surgeon would like to protect weight bearing
Providing Speech Therapy Awareness in Private Schools

There has been limited research in the area of speech and language therapy awareness in Pakistan. The study aims to assess the efficacy of providing speech therapy awareness in private schools through a pre-post model. This Quasi experimental study will be a means of reaching out to schools and directly create awareness regarding the field and its scope. Pre-assessment will be carried out and after which a 45 minutes presentation will be conducted face to face or through a webinar as per school directives. The results will be analysed quantitatively and pre-post assessment of the participants will be measured.

There has been limited research in the area of speech and language therapy awareness in Pakistan. The study aims to assess the efficacy of providing speech therapy awareness in private schools through a pre-post model. the study design is Quasi Experimental study

Sample size: 385. Raosoft Sampling technique: Purposive Sampling Inclusion criteria: Private English medium schools of Islamabad and Rawalpindi. Schools with no speech and language therapists Exclusion criteria: Public Schools and schools who may have visiting or permanent speech therapists on their panel.

Delphi technique will be used for development of a tool for the intervention and to assess the impact of the awareness program.

The teachers will be tested pre and post program and three months after the completion of the program. Three months post they will be a) tested on the same questionnaire b) will determine number of students identified with difficulties c) students referred to a therapist.

Data will be analyzed quantitative means and quantitative data will be analyzed using SPSS

Eligibility Criteria:
Inclusion Criteria:

* Private English medium schools of Islamabad and Rawalpindi. Schools with no speech and language therapists

Exclusion Criteria:

* Public Schools and schools who may have visiting or permanent speech therapists on their panel
Safety, Efficacy of Pylera BID Dosing in Eradication of H. Pylori

The purpose of this study is to evaluate the effect of Pylera when given twice a day. Pylera approved treatment schedule is 3 pills taken 4 times daily, in addition to omeprazole given twice daily. In this trial, subjects with confirmed Helicobacter Pylori infection will receive Pylera treatment and omeprazole twice daily.

This study will include three phases: screening, treatment and follow-up.

Screening: this phase will last a maximum of 15 days and subjects eligibility will be evaluated after informed consent signature. Urea breath test (UBT) will be performed in addition to routine baseline evaluations (physical, lab test, etc).

Treatment: subjects will be treated for 10 days. A "confirmation of eligibility" visit will take place on Day 0 and an "end-of-treatment" visit will take place between days 9-14.

Follow-up: approximately one month post-treatment, eradication of H. pylori will be confirmed through UBT

Eligibility Criteria:
Inclusion Criteria:

* Positive H. pylori status through UBT testing

Exclusion Criteria:

* Documented allergy to any of the drugs contained in the treatment regimen
* Severe renal insufficiency, renal failure or azotemia
* Previous surgery of the upper gastrointestinal tract
* Hepatic failure
* Pre-existing peripheral neuropathies
* Use of any experimental drug within 30 days prior to randomization
Diagnostic Scoring for Small Bowel Obstruction

It is difficult to predict which patients with acute small bowel obstruction require operative intervention and which ones can be handled conservatively. Similarly, strangulation remains difficult decision. The rationale for this observative study is to collect prospective cohort of patients with small bowel obstruction to create scoring system to predict early 1) small bowel obstruction resistant to conservative therapy, 2) strangulation.


Eligibility Criteria:
Inclusion Criteria:

* Computed tomography verified acute small bowel obstruction

Exclusion Criteria:

* \< 18 years old
* Pregnant
* Abdominal surgery within 30 days prior recruitment
* Inflammatory bowel disease
* Small bowel tumor causing obstruction
* Peritoneal carcinosis
* Intraluminal obstruction (bile stone, bezoar, etc.)
* Large bowel obstruction
* Small bowel obstruction caused by abdominal wall hernia
Phase II Study of Single Agent OSI-7904L in Patients With Gastric or Gastroesophageal (GEJ) Cancer

Multi-center, open-label, non-randomized Phase II study to evaluate the efficacy and safety of OSI-7904L in gastric and GEJ cancers. Those patients who do not derive clinical benefit after two cycles may be switched to a commonly used combination regimen.


Eligibility Criteria:
Inclusion Criteria:

Documented locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction No prior chemotherapy for locally advanced or metastatic disease Adequate baseline bone marrow, hepatic and renal function Age \>= 18 years At least one target lesion

Exclusion Criteria:

Active or uncontrolled infections or other serious illnesses or other medical conditions (eg, hepatitis, HIV, chronic alcohol abuse) Symptomatic brain metastases which are not stable
Expanded Access Use of Tucatinib for HER2+ Metastatic Breast Cancer

Physicians interested in requesting a single patient IND should contact Seattle Genetics' Medical Information (medinfo@seagen.com).


Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

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