cyrilzakka/clinical-trials huggingface dataset:
A Study of Tirzepatide (LY3298176) in Participants With Heart Failure With Preserved Ejection Fraction (HFpEF) and Obesity: The SUMMIT Trial

The main purpose of this study is to assess the efficacy and safety of Tirzepatide (LY3298176) in participants with heart failure with preserved ejection fraction and obesity.

The study will continue until approximately 52 weeks after the last participant is randomized. The maximum duration of an individual's participation is estimated to be \~120 weeks and will depend on duration of study enrollment.

Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of stable heart failure (NYHA class II-IV) and left ventricular ejection fraction (LVEF) ≥50%
* Elevated NT-proBNP (N-terminal pro B-type natriuretic peptide) \> 200 pg/ml for participants without atrial fibrillation (AF), or \>600 picogram/milliliter (pg/ml) for participants with AF, Structural heart disease (Left atrial enlargement) or Elevated left ventricular filling pressure
* Estimated glomerular filtration rate (eGFR) \<70 milliliter (ml)/minute (min)/1.73m² at screening, or HF decompensation within 12 months of screening,
* Stable dose of heart failure medications within 4 weeks of screening
* Body mass index (BMI) ≥30 kilograms per meter squared (kg/m²)
* 6MWD 100-425m
* KCCQ CSS ≤80

Exclusion Criteria:

* Have had a major cardiovascular event within the last 90 days of screening
* Have had acute decompensated heart failure within 4 weeks of screening
* Have non cardiac causes of functional impairment such as pulmonary arterial hypertension (PAH), severe chronic obstructive pulmonary disease (COPD), anemia, thyroid disease, musculoskeletal disease or orthopedic conditions
* Presence of cardiac amyloidosis, cardiac accumulation disease, cardiomyopathy and severe valvular heart disease
* HbA1c ≥9.5% or uncontrolled diabetes
* History of proliferative diabetic retinopathy or diabetic maculopathy
* Have a history of pancreatitis
* eGFR \<15 mL/min/1.73 m² or requiring dialysis at screening
Clinical and Biochemical Evidence of Neurogenic Inflammation in Women With Urinary Urgency

The purpose of this study is to gain a better understanding of what causes urinary urgency in women by asking about different symptoms and measuring biomarker levels in their urine. Understanding the underlying causes of urinary urgency will allow us to develop treatment options to better take care of women with urinary urgency.

We propose to test the hypothesis that urinary urgency in women is caused by neurogenic inflammation that is manifested clinically as neuropathic pain and associated with the expression of neuroinflammatory biomarkers in the urine.

Eligibility Criteria:
Inclusion criteria: Age \> 18, urinary urgency (at least mild bother on a single item Urgency Scale), and negative urine dipstick on clean catch.

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Exclusion Criteria:: Urinary incontinence (greater than mild on the Incontinence Severity Index), recent (\<6week) urinary tract infection, active or recent(\<3month) nephrolithiasis, prior diagnosis of congenital urinary tract abnormality, known neurological disorder (multiple sclerosis, Parkinson's, spina bifid, spinal cord injury), recent pregnancy \< 3 months, prior sacral nerve stimulation or Botox injection.

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A Feasibility Study of an AI-Powered Clinical Decision Aid for Personalized Depression Treatment Selection

The Clinical Decision Aid (CDA) is a predictive model that takes as input individual patient characteristics, called 'features', which are inputted by the physician or by patient self-report, and outputs a list of possible treatments, with each treatment associated with a predicted efficacy (likelihood to achieve response and likelihood to achieve remission, each expressed as a percentage). The treatments, which may include any approved treatment for depression, will be presented to the physician who will then make a treatment choice.

Hypothesis 1. There will not be a significant difference in measured non-initial intake appointment lengths between the baseline period and the appointment length measured at two and four months after introduction of the study software and CDA.

Hypothesis 2. Physicians will not subjectively report that using the CDA and study software increased the length of their appointments.

Hypothesis 3. At least 66% of patients and 66% of physicians will rate the trustworthiness of the CDA as a 4 or 5 on a 5 point Likert scale (with higher ratings indicating greater trust).

Hypothesis 4. At least 66% of patients and 66% of physicians will rate the overall usability of the CDA as a 4 or 5 on a 5 point Likert scale (with higher ratings indicating greater usability).

Hypothesis 5. At least 70% of physicians and 65% of patients will still be using the application regularly by the end of the study. For physicians, regularly will be defined as the application being used in every study-related visit. For patients regularly will be defined as completing at least one PHQ-9 and GAD-7 questionnaire on the application per week.

Exploratory hypothesis: Based on our machine learning results to date, we expect between 40-50% of patients starting a new treatment for depression and whose treatment follows the highest probability treatment output by the CDA to remit within 14 weeks. This is exploratory, and the study is not necessarily powered to demonstrate this.

Eligibility Criteria:
Inclusion Criteria:

* All patients of the physicians in the study are diagnosed with major depressive disorder by a physician using DSM-V criteria.
* All participants must be able to provide informed consent.
* Contraception will be used as per established clinical guidelines and usual clinical practice for medications known to cause birth defects. The medications prescribed and the use of and type of contraception will be determined by the physicians in the study in consultation with their patients as would usually occur in clinical practice.

Exclusion Criteria:

* Bipolar disorder type 1 or 2, as the data we have used to train the model does not allow for generalization to bipolar disorder (either pre-existing or as diagnosed according to DSM-5 criteria).
* Inability or unwillingness of individual to give informed consent.
Part-time Patch Therapy for Treatment of Intermittent Exotropia

Intermittent exotropia is the most common type of exotropia in children. Treatment options are surgical and non surgical. Nonsurgical management include Correction of refractive errors, Active orthoptic treatments, Prisms and Occlusion therapy. Benefits of patch therapy are limiting suppression, reducing the frequency and amplitude of the deviation, changing the nature of the deviation (from constant to intermittent exotropia or from intermittent exotropia to exophoria), however, there is a concern that occlusion of the eyes may cause fusion failure and worsen deviation control. According to a few number of studies and controversy among the results of investigations, the investigators designed this randomized clinical trial study to determine the effect of partial patch therapy on the deviation control of children with intermittent exotropia.


Eligibility Criteria:
Inclusion Criteria:

* Intermittent distance exotropia or constant distance exotropia at least 15Δ and intermittent near exotropia or exophoria

Exclusion Criteria:

* No child's cooperation in evaluation of deviation control and regular visits for follow-up examinations
* Anisometropia more than 1.50 D, hypermetropia more than 3.50 D, and myopia more than 4.50 D on cyclorefraction
* History of previous treatments including eye occlusion, minus therapy, and strabismus surgery
* Any eye and systemic diseases other than strabismus including neurologic diseases and developmental delay.
Treatment of Recalcitrant Hand and Foot Warts With Intense Pulsed Light - a Randomized Controlled Trial

The purpose of the study is for recalcitrant hand and foot warts to compare the efficacy of treatment with Intense Pulsed Light and paring versus paring alone.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Recalcitrant warts
* No previous IPL treatment of warts

Exclusion Criteria:

* Immunosuppressive treatment
* Patients suffering from HIV, diabetes or other immunosuppressive diseases
* Pregnancy
* Previous IPL treatment
* Patients with a tendency to prodyce keloids or hypertrophic scars
* Mosaic and flat warts
* Lack of informed consent
Screening of Cancer Patients to Assess Impact of COVID-19

The purpose of this study is to investigate the impact of COVID -19 in the cancer patient population. This will be done by looking at the rate of asymptomatic COVID-19 infection in cancer patients receiving cancer therapy, as well as their immune response.

This is a sub-study of the U-DEPLOY study: UHN Umbrella Trial Defining Coordinated Approach to Pandemic Trials of COVID-19 and Data Harmonization to Accelerate Discovery. U-DEPLOY helps to facilitate timely conduct of studies across the University Health Network (UHN) and other centers.

Given increasing community transmission and the possibility of asymptomatic carriage of virus, it is important to study whether asymptomatic shedders of virus are playing a role in propagating the pandemic. There is currently little data available regarding cancer patients, yet, this population may be particularly susceptible to the COVID-19 infection.

Despite the cancer patient population being at higher risk of COVID-19, no systematic screening has been established and no biomarkers have been identified to determine which patient is at higher risk.

This study will screen patients on active cancer therapy for COVID-19 as a standard of care or a research nasopharyngeal test. Blood samples may also be taken to assess any patient response to the virus and optional saliva samples may also be taken to assess the feasibility of using patient saliva for detection of SARS-CoV-2 virus in patients with impaired saliva production (eg. secondary to cancer treatments such as radiation, chemotherapy, and/or surgery).

Eligibility Criteria:
Inclusion Criteria:

* Patients having an active malignancy who are planned to start therapy within 6 weeks of consent or are receiving a treatment for active malignancy.
* The patient falls under either of the following categories:

  1. Asymptomatic for COVID-19 (as per daily screening at the hospital entrance).
  2. Has symptoms similar to those of COVID-19 (e.g. fever or flu-like symptoms such as cough or shortness of breath) that are assessed by the overseeing Investigator as being related to disease and unrelated to COVID-19 infection.

Note: Patients who recovered from previous COVID-19 infection will be eligible.

* No contraindication to performing a NP swab and blood work.

Exclusion Criteria:

* Any patients with fever, or flu-like symptoms assessed by the Investigator to be related or potentially related to COVID-19 infection will not be eligible.
* Eastern Cooperative Oncology Group (ECOG) Performance Status of 3-4
Pharmacokinetics of Amikacin and Cefuroxime in Critically Ill Patients.

Infections in critically ill patients are a major healthcare problem and an important source of morbidity and mortality. Since critically ill patients often have altered pharmacokinetics (PK) compared to non-critically ill patients there is a substantial risk that present standard dosing regimens of antibiotics lead to suboptimal outcomes for patients on the ICU or the ED. To prevent the risk of inadequate dosing in ICU patients, it is important to fully understand the PK of antibiotics in this vulnerable group in order to optimize the dosing regimens.

With this study, the investigators will describe the pharmacokinetics of cefuroxime and amikacin in ICU and ED patients. A heterogeneous population of ICU and ED patients will be included to be able to find which factors might influence the pharmacokinetics of these drugs and to what extent. By using population modeling the investigators will simulate different dosing regimens and MIC values and compare probability of target attainment between each of these dose and MIC combinations. This will allow the investigators to optimize dosing regimens of cefuroxime and amikacin in critically ill patients.


Eligibility Criteria:
Inclusion Criteria:

1. The patient is admitted to the ICU or ED;
2. The patient is at least 18 years of age on the day of inclusion;
3. Is managed with a central venous catheter or arterial line;
4. Is treated with amikacin and/or cefuroxime as standard care.

Exclusion Criteria:

1. Has previously participated in this study.
Study of NUV-422 in Combination With Enzalutamide in Patients With mCRPC

NUV-422-04 is an open-label Phase 1b/2 dose escalation and expansion study designed to evaluate the safety and efficacy of NUV-422 in combination with enzalutamide. The study population is comprised of adults with mCRPC. Patients will self-administer NUV-422 and 160 mg enzalutamide orally in 28-day cycles. Patients will be treated until disease progression, toxicity, withdrawal of consent, or termination of the study.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of metastatic castration-resistant prostate cancer with disease progression despite castrate levels of testosterone
2. Have radiographic or biochemical evidence of progression as determined by Investigator per standard criteria
3. Have no known active or symptomatic central nervous system (CNS) disease
4. Prior therapy with abiraterone required and:

   * For Phase 1b only: up to 2 prior taxane-based chemotherapy regimens allowed for castration-resistant disease
   * For Phase 2 only: Patients must not have received prior taxane-based chemotherapy for castrate-resistant disease or prior treatment with CDK inhibitors
5. Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤ 2
6. Adequate bone marrow and organ function
7. Eligible to receive enzalutamide
8. Life expectancy of \> 6 months

Exclusion Criteria:

1. History of seizure or any condition that may predispose to seizure (prior cortical stroke or significant brain trauma)
2. Have received chemotherapy, hormonal therapy (with the exception of ongoing LHRH analogs) radiation, or biological anti-cancer therapy within 14 days prior to first dose of NUV-422 and enzalutamide
3. Received treatment with an investigational agent for any indication within 14 days for non-myelosuppressive agent or 21 days (or \< 5 half-lives) for myelosuppressive agent prior to the first dose of NUV-422 and enzalutamide
4. Requires medications that are known to be strong inducers and /or inhibitors of CYP3A4/5 enzymes, except enzalutamide

   * For Phase 1b only: Requires medications that are known to be moderate inducers and /or inhibitors of CYP3A4/5 enzymes, except enzalutamide
5. Prior therapy with enzalutamide, apalutamide, darolutamide, or investigational androgen receptor inhibitors
6. Known allergy or hypersensitivity to enzalutamide
The Use of Low Dose Metronidazole to Decrease Postoperative Pain After Endometriosis Surgery

The purpose of this study is to determine a difference in participant reported pain after endometriosis surgery in participants given oral metronidazole versus placebo.

The study is a prospective, randomized, placebo-controlled trial. Women scheduled for endometriosis surgery between 18-50 years of age will be invited to participate in the study.

Participants with surgically staged endometriosis will be randomized to the metronidazole plus routine postoperative care arm or the placebo plus routine postoperative care arm. Participants will take study or placebo drug for a total of 14 days.

Participants will complete surveys at baseline and postoperatively at 6 weeks, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years reporting intensity of endometriosis associated pain on a visual analog scale, pregnancy outcomes, quality of life, and sexual health.

Eligibility Criteria:
Inclusion Criteria:

* Able to give informed consent
* Women aged 18-50 years old
* Scheduled to undergo excision of endometriosis
* Able to read and write in English and or Spanish
* Pain score \> 2 on a 10 point visual analogue scale at baseline
* Negative screening by CAGE questionnaire

Exclusion Criteria:

* Refusal to surgery
* Contraindication to surgery
* Known allergy to metronidazole
* Known allergy to any component in gelatin placebo capsules
* Scheduled hysterectomy
* Endometriosis excision surgery within the last 3 months
* Elevated serum creatinine
* Abnormal liver function test greater than 2 times the normal
* Current pregnancy
* Breastfeeding
* Use of Disulfiram within the last 2 weeks
* History of Cockayne syndrome
* Inability to abstain from alcohol during the use of study drug
Video-Based Games for Upper Limb Rehabilitation in Cerebral Palsy

The aim of the present study is to compare the effects of Neurodevelopmental Treatment (NDT)-based upper limb rehabilitation and video-game based therapy (VGBT) with Nintendo® Wii and LMC games on upper extremity functions in patients with Cerebral Palsy (CP).

The investigators hypothesized that VGBT using the Nintendo® Wii and LMC would be a usable tool to train manual dexterity in patients with CP as comprehensive and holistic therapy.

The NDT program for both groups will be routinely applied according to each child's individual needs and included tonus regulation, support of sensation, perception and motor development for gross motor function.

The two different patient-centered rehabilitation programs will be conducted with an average of one hour sessions three times a week for 8 weeks in both groups. The two different patient-centered programs will be as VGBT with Nintendo® Wii and LMC games (Group I) and NDT-based upper limb rehabilitation (Group II).

Eligibility Criteria:
Inclusion Criteria:

The health committee report has received a CP diagnosis

* Being between 5-18 years of age
* According to Modifiye Ashworth Scale (MAS), upper extremity spasticity (0), (1), (1+)
* Ability to adapt to exercises (According to the health report mental level normal or "mild mental retardation"

Exclusion Criteria:

* Botulinium Toxin (BOTOX) injection for the upper extremity in the last 6 months
* Does not have epileptic epilepsy
* Any person who has been diagnosed as having any absence of a cardiac or orthopedic condition
* Admission of family treatment
Clinical Assessment Study in Crigler-Najjar Syndrome

This is a Pre-Phase 1 prospective, non-interventional clinical assessment study to evaluate Crigler-Najjar syndrome subjects requiring daily phototherapy, aged 1 year and older.


Eligibility Criteria:
Key Inclusion Criteria:

* Subject has a diagnosis of Crigler-Najjar syndrome resulting from a confirmed mutation in the UGT1A1 gene
* Subject is aged equal or greater than 1 year of age
* Subject receives daily phototherapy for a minimum of 6 hours within a 24-hour period (daily illumination time)

Exclusion Criteria:

* Subject is currently participating in an interventional study or has received gene or cell therapy
* Subject has received a whole liver, partial liver, or hepatocyte transplant; or subject has a liver transplant scheduled within the planned participation period of this study
* Subject has significant cholestatic disease, in the opinion of the investigator
* Subject is receiving phenobarbital or other known inducer of UGT1A1 within 30 days of screening
* Subject has any clinically significant underlying liver disease (other than Crigler-Najjar syndrome), in the opinion of the investigator
* Subject has a history of, or currently has, a clinically important condition other than Crigler-Najjar syndrome, in the opinion of the investigator
Clinical Follow-up Study of Rituximab in the Treatment of Nephrotic Syndrome in Children

This was a retrospective study. Children who were diagnosed with refractory nephrotic syndrome and treated with rituximab (RTX) and followed up for ≥1 year in the Department of Pediatrics, the First Affiliated Hospital of Xiamen University from March 2020 to March 2026 were enrolled. Personal information, past medical history, clinical examination data and follow-up data before and after the use of RTX were extracted from the medical record system. (1) The median relapse-free survival, the number of relapses and the adverse reactions of RTX were compared before and after RTX treatment, and the clinical efficacy and safety of RTX were evaluated. (2) By comparing the annual relapse frequency, reduction and withdrawal of steroids and immunosuppressive agents, B cell reconstitution and adverse drug reactions between prophylactic RTX and post-relapse RTX maintenance regimens; (3) Multivariate analysis of risk factors for recurrence of nephropathy after RTX treatment. (4) growth indicators monitoring patient evaluation and RTX medical economic benefit analysis.


Eligibility Criteria:
Inclusion Criteria:

* Children clinically diagnosed with FRNS/SDNS/SRNS with complete clinical data;
* age \< 18 years old;
* For the first time using RTX treatment, and used in nephrotic syndrome ease;
* The follow-up for 1 year or more.

Exclusion Criteria:

* Congenital or infantile nephrotic syndrome, secondary nephrotic syndrome (such as lupus nephritis, IgA nephropathy, purpura nephritis, hepatitis B nephritis, etc.);
* Active stage of hepatitis, complicated with severe infection, severe deficiency of immune response, malignant diseases;
* Estimated glomerular filtration rate (GFR) \<60mL/min/1.73m2.
ACURATE TA™ Valve Implantation: SAVI Registry (Surveillance Plan #2011-02) (TA-SAVI)

Post-market registry on ACURATE TA™ Transapical Aortic Bioprosthesis and ACURATE TA™ Delivery System implantation in patients presenting severe symptomatic aortic stenosis to provide safety surveillance of the device.

A single arm, prospective, multicenter, non-randomized and open registry up to 1 Year Follow-up with the Symetis ACURATE TA™ which is an aortic bioprosthesis for minimal invasive implantation via transapical access to treat patients with severe symptomatic aortic stenosis where surgical aortic valve replacement (SAVR) via open surgery is considered to be associated with high surgical risk for evaluating the safety and performance of the implantation and the safety at 30-Day Follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Patient has severe aortic stenosis
* Native aortic annulus diameter from ≥ 21mm up to ≤ 27mm
* Patient willing to participate in the study and provides signed EC-approved informed consent
* The subject and treating physician agree the subject will return for all required post-procedure follow-up visits

Exclusion Criteria:

* Patients are excluded from the registry if they are not eligible for transcatheter treatment of severe aortic stenosis with the ACURATE TA™ and Delivery System as per the Instructions For Use.