cyrilzakka/clinical-trials huggingface dataset:
A Study of REC-1245 in Participants With Unresectable, Locally Advanced, or Metastatic Cancer

This is a multi-center, open-label study to investigate the safety, tolerability, PK, PD, and preliminary activity of REC-1245 administered orally on a once daily (QD) schedule in participants with unresectable, locally advanced, or metastatic solid tumors.

Approximately 85 individuals will be enrolled in this open-label Phase 1/2 study, allocated 55 individuals in Phase 1 and 10-30 individual's in Phase 2. The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of REC-1245 for the treatment of participants with unresectable locally advanced or metastatic solid tumors. Participants will receive treatment with REC-1245 for up to 2 years.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older Have histologically-confirmed unresectable, locally advanced, or metastatic select solid tumors or select relapsed / refractory lymphoma Have experienced progressive disease, relapsed disease, or be intolerant to at least one established standard systemic anti-cancer treatment for a given tumor type, or have been considered ineligible for standard therapy.

ECOG performance status ≤ 1 Measurable disease at baseline per RECIST 1.1 / Lugano criteria and documented by computed CT and / or MRI

Exclusion Criteria:

* Received treatment with another RBM39 degrader Clinically significant gastrointestinal (GI) or GI malabsorption
Oxcarbazepine Versus Placebo in Childhood Autism

The proposed study is designed to assess the effectiveness of treatment with Oxcarbazepine vs. placebo in childhood/adolescent autism. This is a twelve-week study involving twenty subjects between the ages of five and seventeen with a diagnosis of autism.

The proposed study is designed to assess the effectiveness of treatment with Oxcarbazepine vs. placebo in childhood/adolescent autism. This is a twelve-week study involving twenty subjects between the ages of five and seventeen with a diagnosis of autism. Subjects will receive a psychiatric and medical evaluation by the study psychiatrist to see if she/he has any psychiatric or medical illnesses that would interfere with their ability to participate in this study. These evaluations may take up to an hour to complete. In addition, subjects will be asked to participate in a psychiatric interview designed to determine the child's diagnosis and current problem areas. The subject's parent will also be asked to fill out psychiatric questionnaires. The interview and questionnaires may take up to 4 hours to complete.

Eligibility Criteria:
Inclusion Criteria:

* Subject has autism.
* Subject is between five and seventeen years of age
* Subject is not hospitalized.

Exclusion Criteria:

* Subject has been diagnosed with a psychopathic disorder or a mood disorder, including depression or bipolar disorder.
* Subject has displayed self-injurious behavior.
* Subject has an active seizure disorder or epilepsy.
* Subject has an unstable medical illness.
* Subject has undergone brain injury.
* Subject has a history of diabetes.
* Subject has a history of prior treatment with oxcarbazepine of 600 mg/day for 6 weeks.
* Subject has used other study drugs within the previous 30 days.
* Subject is a pregnant female or unwilling to use acceptable contraception if sexually active.
Physician Preference Study of ShuntCheck - Madsen

ShuntCheck can be used to detect CSF flow in asymptomatic hydrocephalus patients and can be used to detect no-flow in symptomatic patients with shunt obstruction.

Secondarily, the ShuntCheck test will yield the clearest results when patients are tested sitting up (or alternatively while supine)


Eligibility Criteria:
Inclusion Criteria:

1. Subjects must be 0 - 85 years of age, of any race or sex with parent consent for minors
2. Subjects must have a chronically indwelling ventriculo-peritoneal shunt that is palpable along the clavicle.
3. Subjects must be physically stable as determined by the physician.

Exclusion Criteria:

1. Subjects with the presence of an open wound at the shunt site that could interfere with the collection of ShuntCheck data.
2. Subjects unable to lie supine with head elevated 30 degrees or less
3. Subjects who have had shunt surgery within two weeks.
4. Inability or unwillingness of subject to endure the test.
5. Other judgments of the investigator.
Effects of Weight Loss on Hepatic and Muscle Lipid Content and on Insulin Sensitivity on Obese Adolescents With NAFLD

To assess whether reversal of fatty liver by moderate weight loss (8% of body weight) will lead to improvements in insulin sensitivity, which will be associated with changes in both glucose status and lipid profiles, in obese children and adolescents with fatty liver who have normal glucose or pre-diabetes.

This study will have two groups: one group that eats a moderate calorie, low-fat diet and is weighed regularly (every other week for 16 weeks) and the other who receives traditional diet therapy and returns in 16 weeks. Both groups will undergo procedures that test glucose tolerance and measure liver and muscle fat content before and after study period.

Eligibility Criteria:
Inclusion Criteria:

* 10 to 21 yrs of age
* Non-smoking
* BMI \>95th percentile for age and gender, but BMI \<40
* Suspicion of fatty liver, with a high ALT (\>35)
* Normal glucose tolerance or prediabetes (impaired glucose tolerance or impaired fasting glucose)

Exclusion Criteria:

* Females of child-bearing potential who are not using birth control
* Pregnant or lactating females
* Current medications except oral anti-diabetic medications and hormonal birth control
* Lipid-lowering medication that increases liver enzymes
* Significant kidney dysfunction (creatinine \>1.5 mg/dL)
* Current heavy ethanol use or recent history of binge drinking
* History or evidence of hepatitis A, B, or C, Wilson's Disease, or alpha-1-antitrypsin deficiency
* Known to be HIV positive
* Symptomatic angina pectoris or cardiac insufficiency as defined by the NYHA classification as Functional Class III or IV
* Major vascular event within 6 months of screening (e.g. MI, stroke)
* Active cancer within 5 years prior to screening
* Current systemic disease, including type 1 or 2 diabetes
* Enrolled in another research study within 1 month prior to screening
* Implanted paramagnetic material (all subjects will need to fill out the Yale Magnetic Resonance Center safety checklist)
* Anemia (HCT \<35%)
Proof of Concept Treatment Study of Orally Administered VH4004280 or VH4011499 in HIV-1 Infected Adults

The primary purpose of the study is to evaluate the antiviral activity of orally administered VH4004280 and VH4011499 monotherapy over 10 days in human immunodeficiency virus (HIV-1) infected Treatment-Naïve (TN) participants.


Eligibility Criteria:
Inclusion Criteria:

* Participants who are overtly healthy (other than HIV-1 infection).
* Screening cluster of differentiation-4 (CD4+) T-cell count greater than or equal to (≥)200 cells/microliter (µL).
* Documented HIV-1 infection and Screening plasma HIV-1 RNA ≥3000 copies/milliliter (mL).
* Treatment-naïve: Defined as no antiretroviral therapy received after the diagnosis of HIV-1 infection. Prior use of oral pre-exposure prophylaxis (PreP) is permitted. Prior use of parenteral PreP is exclusionary.
* Has body mass index (BMI) within the range of 18.5-31.0 kilograms per meter square (kg/m\^2).
* Participants male at birth must use male condoms and participants female at birth who are of childbearing potential must be using acceptable forms of birth control.
* Participants capable of giving signed informed consent.
* Participant must be willing and able to start locally accessible and commercially available combination antiretroviral therapy after the monotherapy period.

Exclusion Criteria:

* Women who are breastfeeding or plan to become pregnant or breast feed during the study.
* Participants with acute HIV infection.
* Any evidence of an active Centers for Disease Control and Prevention (CDC) Stage 3 disease.
* Untreated syphilis infection.
* Ongoing malignancy other than certain localised malignancies.
* Treatment with immunomodulating agents or any agent with known anti-HIV activity.
* Has exclusionary psychiatric, hepatic, cardiovascular gastrointestinal, renal condition.
* Participant having any condition which, in the opinion of the investigator, may interfere with the absorption, distribution, metabolism or excretion of the study drugs or render the participant unable to take oral medication.
* Participants having exclusionary electrocardiogram (ECG) findings.
* Participants who have been exposed to any prohibited medication or vaccine.
* Participant positive for hepatitis B or hepatitis C.
* Participants with exclusionary safety laboratory (e.g Grade 3 or greater abnormality).
* Participants who have positive results for illicit drug use, regular use of drugs of abuse and/or excessive alcohol use.
Long-Term Safety of Febuxostat in Subjects With Gout.

The purpose of this study is to evaluate the long-term safety of febuxostat, once daily (QD), in maintaining serum urate levels within clinically acceptable levels in subjects with gout.

Uric acid is the end product of purine degradation in humans. Hyperuricemia, a urate concentration in serum exceeding the limit of urate solubility (approximately 7.0 milligrams per deciliter \[mg/dL\]), is a common biochemical abnormality. Aberrations in any of the multiple mechanisms involved in the production and/or excretion of uric acid may increase serum urate concentrations, with persistent hyperuricemia as a marker for extracellular fluid monosodium urate supersaturation. As such, hyperuricemia is a necessary (but often not sufficient) risk factor for monosodium urate crystal deposition in tissues and is the fundamental pathophysiological process underlying the clinical manifestations of gout, which is a chronic disease characterized by urate crystal formation and deposition in joints and bones. Gout may progress from episodic attacks of acute inflammatory arthritis to a disabling chronic disorder characterized by deforming arthropathy; destructive deposits of urate crystals (tophi) in bones, joints, and other organs; structural and functional renal impairment due to interstitial urate crystal deposition; and urinary tract stones composed entirely or in part of uric acid crystals. Management of gout requires chronic treatment aimed at lowering serum urate into a subsaturating range (usually \<6.0 mg/dL) in which crystal formation and deposition are prevented or reversed.

Febuxostat (TMX-67) is a non-purine selective xanthine oxidase inhibitor being developed as an orally administered agent for management of hyperuricemia in patients with gout.

Subjects who want to participate in this study will have successfully completed study TMX-00-004 (NCT00174967).

All participants will initially receive an 80 mg dose. Dose titrations will occur in order to obtain and maintain clinically acceptable serum urate levels.

Eligibility Criteria:
Inclusion Criteria:

* Hyperuricemia (serum uric acid ≥8.0 mg/dL upon entering parent study TMX-00-004).
* Must meet American College of Rheumatology criteria for gout.
* Must have adequate renal function (serum creatinine \<1.5 mg/dL).
* Must have completed four weeks of double-blind dosing in Study TMX-00-004.
* Must not have experienced any serious study drug-related Adverse Events in Study TMX 00-004.
* Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from Screening throughout the duration of the study.

Exclusion Criteria:

* History of xanthinuria
* Alcohol consumption \>14/week
* Has a History of significant concomitant illness
* Has active liver disease.
* Has a body mass index greater than 50 kg/m2
* Any other significant medical condition that would interfere with the treatment, safety or compliance with the protocol, as defined by the investigator.
Reboxetine for Sleep Apnoea After ENT Surgery

This pilot study will establish the feasibility of a larger trial to investigate whether reboxetine, a medication used to treat depression, can reduce the severity of obstructive sleep apnea (OSA) including increased blood oxygenation in post-surgical OSA patients where positive airway pressure (CPAP) therapy is either frequently poorly tolerated or not an option immediately post surgery. In this randomized, placebo-controlled, double-blind study, participants will use at-home sleep monitoring equipment before and after surgery plus measures of oxygenation. They will be prescribed either reboxetine or a placebo for seven days after surgery and complete questionnaires at the beginning and end of the study.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Undergoing elective upper airway surgery
* History of obstructive sleep apnoea (OSA)

Exclusion Criteria:

* Clinically significant cardiac disease (e.g., arrhythmia, coronary artery disease, or cardiac failure)
* History of clinically significant urinary retention, bladder outlet obstruction, or benign prostatic hyperplasia
* Poorly controlled hypertension
* Epilepsy
* History of schizophrenia, schizoaffective disorder or bipolar disorder according to Diagnostic and Statistical Manual of Mental Disorders-V or International Classification of Disease 10th edition criteria
* History of attempted suicide or suicidal ideation within 1 year prior to screening, or current suicidal ideation
* Narrow angle glaucoma
Multi-Center Randomized Clinical Trial Irreversible Electroporation for the Ablation of Localized Prostate Cancer

Multi-centre Randomized Clinical Trial: 106 patients with confirmed unilateral high-volume low risk (Gleason score 3 + 3) or intermediate risk prostate cancer (Gleason score 3 + 4) will undergo an IRE treatment. These patients will be randomized into one of the two groups of the study.

Group 1: Focal ablation of the prostate at the side of the positive biopsies (focal-ablation) Group 2: Extended ablation of the prostate (extended ablation)

Patients will have an ultrasound of the prostate and the imaging data will be entered into the Planning Software system of the IRE-device. The volume of the prostate is measured and a specified ablation zone will be determined. The patients will be admitted for overnight stay in the hospital on the morning of the scheduled IRE procedure. The IRE will be performed under general anaesthetic and the specified zone identified in the planning stage will be ablated. Two to four IRE electrode needles will be placed into the prostate under ultrasound image guidance with a perineal approach using a brachytherapy grid. When the needles are in place, electric pulses of one to two minutes duration are used to ablate the specified zone. The total procedure time will be approximately 1 hour.

Safety data will be collected and patients will be followed up at 1 day post-operatively, 1 month, 3 months, 6 months and 1, 2 and 3 year(s) post IRE.


Eligibility Criteria:
Inclusion Criteria

1. Histologically confirmed organ-confined unilateral prostate cancer with adjacent positive biopsies on transperineal template prostate biopsies or MRI targeted biopsies in combination with systematic biopsies (clinical stage T1c-T2b)
2. Gleason sum score 6 or 7
3. PSA \<15 ng/ml or PSA \> 15 ng/mL counselled with caution
4. Life expectancy of \> 10 years

Exclusion Criteria

1. Bleeding disorder as determined by prothrombin time (PT) \> 14.5 seconds, partial thromboplastin time (PTT) \> 34 seconds, and Platelet Count \< 140/uL
2. No ability to stop anticoagulant or anti-platelet therapy for 7 days prior the procedure.
3. Active urinary tract infection (UTI)
4. History of bladder neck contracture
5. Anaesthesia Surgical Assignment category IV or greater
6. History of inflammatory bowel disease
7. Concurrent major debilitating illness
8. Prior or concurrent malignancy except for basal cell carcinoma of the skin
9. Cardiac history including arrhythmias, ICD or pacemaker
10. Prostate calcifications greater than 5 mm.
11. Biologic or chemotherapy for prostate cancer
12. Hormonal therapy for prostate cancer within 6 months prior to procedure
13. Previous radiation to pelvis
14. Transurethral resection of the prostate / Urethral stent
15. Prior major rectal surgery (except haemorrhoids)
"Quidel Reader Influenza A + B Test 510(k) and CLIA Waiver Field Study"

The objective of this study is to demonstrate the clinical performance of the Quidel Reader Influenza A+B test and Quidel Reader with the following sample types: nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash. Clinical performance will be based on comparison of Quidel Reader Influenza A+B results to cell culture at a Central Reference or Alternative Laboratory.

A sufficient number of subjects will be enrolled to achieve a required minimum of cell culture-positive specimens for each sample type, nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash.

* The 510(k) study will include combined results from all sites and require the following for all three sample types: a minimum of 50 fresh positive results for influenza A, and 30 fresh positive results for influenza B.
* The CLIA Waiver submission will include combined results from all sites for a total of 120 positive specimens for both influenza A and influenza B. The nasal swab will be the primary sample type planned for the CLIA Waiver submission. However, depending upon the prevalence of influenza, nasopharyngeal swab and/or nasopharyngeal aspirate/wash may also be submitted for CLIA Waiver.

Eligibility Criteria:
Inclusion Criteria:

1. Male or Female, of all ages (assuming appropriate consent is obtained).
2. Must currently be exhibiting symptoms characteristic of influenza-like-illness (ILI).

For example:

1. Fever, ≥ 38º C (100º F), either at the time of the visit or onset within the past two (2) days.
2. Nasal congestion
3. Rhinorrhea
4. Sore throat
5. Cough
6. Headache
7. Myalgia
8. Malaise

Exclusion Criteria:

1. Has undergone treatment with anti-influenza antivirals within the previous 7 days, including, for example, one or more of the following, but not be limited to Amantadine, Rimantadine, Ribavirin, Oseltamivir, Zanamivir or any other antiviral currently available in these classes.
2. Has been vaccinated by means of an influenza nasal spray/mist vaccine within the previous 7 days.
3. Unable to understand and consent to participation; for minors this includes parent or legal guardian.
Efficacy and Safety of Cauliflower Mushroom Extract on Promotion of Immunity

The investigators performed a 12-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Cauliflower Mushroom extract on promotion of immunity. The investigators measured promotion of immunity parameters , including Cytotoxicity, Cytokine (IL-4, IL-10, IFN- γ, TNF-α), and CBC (WBC, RBC, Hb, Hct, MCV, MCH, MCHC, PLT), and monitored their blood pressure.


Eligibility Criteria:
Inclusion Criteria:

* Males and females 30-65 years old
* Weight within ±30% of ideal body weight
* Able to give informed consent

Exclusion Criteria:

* WBC concentration below 3000 ㎕
* Allergic or hypersensitive to any of the ingredients in the test products
* Diagnosed of gastrointestinal disease such as Immune-related diseases, severe hepatic, renal failure, and diabetes
* History of reaction to any of the test products or of gastrointestinal diseases such as Crohn's disease or gastrointestinal surgery
* History of alcohol or substance abuse
* Participation in any other clinical trials within past 2 months
* Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study
* Pregnant or lactating women etc.
Genetic Diagnosis and Human Growth Hormone Treatment in Small for Gestational Age Children With Short Stature

This study is a multi-center, retrospective and non-interventional research. In this study, a total of 150 short children who were small for gestational age and had been treated with recombinant human growth hormone (rhGH) are selected for genetic testing. The aims of this study are to analyze the genetic etiology of SGA children with short stature, and to compare the efficacy and safety of rhGH treatment in subjects with different etiologies.


Eligibility Criteria:
Inclusion Criteria:

1. Single birth, clinical diagnosis of SGA;
2. rhGH treatment beginned before puberty (Tanner stage I), regardless of gender;
3. Before starting rhGH treatment, height was lower than -2 SDS compared with normal children of the same age and sex;
4. All the subjects and their guardians signed the informed consent and the informed consent for genetic testing.

Exclusion Criteria:

1. No efficacy and safety data were recorded after treatment with rhGH;
2. A history of blood transfusion within 3 months before the collection of the genetic blood samples, or a history of bone marrow transplantation between rhGH treatment and the enrollment in this study;
3. Other conditions that the investigator considered unsuitable for inclusion in this study.
Cognitive Remediation and Functional Skills Training in Schizophrenia

This randomized trial is examining whether a treatment called cognitive remediation is more effective when it is paired with a social and functional skills training component.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of schizophrenia or schizoaffective disorder
* Enrolled in outpatient mental health care
* Reading level of 6th grade or higher
* English speaking

Exclusion Criteria:

* Medical conditions known to affect cognition