cyrilzakka/clinical-trials huggingface dataset:
Tanshinone in Polycystic Ovary Syndrome

Tanshinone was originally isolated from dried roots of Salvia miltiorrhiza bunge. In Chinese medicine, this herb has been widely prescribed for several pathologies, including diabetes, acne, cardiovascular disease.It has been demonstrated that the therapeutic benefit of cryptotanshinone on prenatally androgenized rats may be mediated by its dual regulation of key molecules during both insulin signaling and androgen synthesis.The purpose of this study is to determine whether tanshinone may prove effective in eradicating Polycystic Ovary Syndrome (PCOS) symptomatology.


Eligibility Criteria:
Inclusion Criteria:

* Presence of PCOS diagnosed based on the Androgen Excess Society criteria. All subjects must have hyperandrogenism (hirsutism and/or hyperandrogenemia), ovarian dysfunction (oligoanovulation and/or polycystic ovaries), and exclusion of other androgen excess related disorders. Oligomenorrhea is defined as an intermenstrual interval \>35 days or \<8 menstrual bleedings in the past year. Amenorrhea is defined as an intermenstrual interval \>90 days. Clinical hyperandrogenism is defined as a Ferriman-Gallwey (FG) score ≥5
* Age of women from 18 to 35 years；
* No desire of children within 6 month and use condoms for contraception.

Exclusion Criteria:

* Use of hormonal drugs or other medications, which can affect the results of the study especially Chinese herbal prescriptions in the past 12 weeks；
* Patients with other androgen excess endocrine disorders including 21-hydroxylase deficiency, hyperprolactinemia, Cushing syndrome, severe insulin resistance, thyroid dysfunction；
* Patients with history of sever cardiac , pulmonary, hepatic, renal, neurologic disease or mental illness；
* Pregnancy or lactation.
A Study to Learn About the Effects of the Combination of Elranatamab (PF-06863135) and Iberdomide in Patients With Relapsed or Refractory Multiple Myeloma (MagnetisMM-30)

The main purpose of the study is to understand how safe and tolerable is elranatamab when given along with iberdomide.

There are 2 parts to this study. Part 1 will look at how safe and tolerable is elranatamab when given with iberdomide. Part 2 will look at the correct amount of this combination that can be given to patients with relapsed or refractory multiple myeloma.

Myeloma is a type of cancer that begins in plasma cells (white blood cells that produce antibodies). Refractory means a disease or condition that does not respond to treatment. Relapsed means the return of a disease after a period of improvement.

All study medicines are given in cycles that last 28 days. Everyone taking part in this study will receive elranatamab as a shot under the skin. Iberdomide will be taken by mouth once a day for 21 days over a 28-day cycle.

Participants will receive study medicine until:

* their disease progresses or,
* they experience unacceptable side effects or,
* they choose to no longer take part in the study.

The study will look at the experiences of people receiving the study medicines. This will help see if the study medicines are safe and can be used for multiple myeloma treatment.


Eligibility Criteria:
Inclusion Criteria:

* Prior diagnosis of multiple myeloma as defined by IMWG criteria
* Measurable disease based on IMWG criteria as defined by at least 1 of the following:
* Serum M-protein ≥0.5 g/dL by SPEP
* Urinary M-protein excretion ≥200 mg/24 hour by UPEP
* Serum immunoglobulin FLC ≥10 mg/dL (≥100 mg/L) AND abnormal serum immunoglobulin kappa to lambda FL ratio (\<0.26 or \>1.65)
* Part 1: Received 2-4 prior lines of therapy for multiple myeloma, consisting of at least 1 immunomodulatory drug and 1 proteasome inhibitor.
* Part 2: Received 1-3 prior lines of therapy for multiple myeloma, consisting of at least 1 immunomodulatory drug and 1 proteasome inhibitor.
* ECOG performance status 0-1
* Resolved acute effects of any prior therapy to baseline severity or CTCAE Grade ≤1

Exclusion Criteria:

* Plasma cell leukemia, Smoldering multiple myeloma, Waldenström's macroglobulinemia, Amyloidosis, POEMS Syndrome
* Impaired cardiovascular function or clinically significant cardiovascular diseases
* Stem cell transplant within 12 weeks prior to enrollment or active graft vs host disease
* Participants with any active, uncontrolled bacterial, fungal, or viral infection
* Any other active malignancy within 3 years prior to enrollment, except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ
* Previous treatment with:
* BCMA-directed or CD3 redirecting therapy
* Iberdomide (CC-220) or Mezigdomide
* Administration of strong inhibitor or inducer of CYP3A4/5 within 2 weeks prior to dosing and during the study
* Administration with an investigational product within 30 days preceding the first dose of study intervention
* Participant is unable or unwilling to undergo protocol required thromboembolism prophylaxis
A Study of RX108 in Patients With Locally Advanced or Metastatic Solid Tumors

RX108 is a novel, potent, small-molecule inhibitor of Na+/K+-ATPase. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK) and efficacy of RX108 in patients with locally advanced or metastatic solid tumors.

This is a open-label, two-part study comprised of a dose escalation part and a dose expansion part. In the dose escalation part, RX108 will be administered in ascending doses to evaluate the safety and tolerability of RX108 and determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D). The dose expansion part will assess the safety, pharmacokinetics, and efficacy of RX108 at the RP2D.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed locally advanced or metastatic cancer that has failed all systemic therapies known to confer clinical benefit
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Minimum age of 18 years
* Adequate hematologic, hepatic and renal function
* Written Informed Consent
* Must agree to use adequate contraception (females and males)

Exclusion Criteria:

* History of certain cardiac abnormalities
* History of inadequate pulmonary function
* Symptomatic brain metastasis
* Treatment with prohibited medications
* Known contra-indication to digoxin
* Treatment with any unapproved therapies for cancer, or any other anti-cancer therapy within 3 weeks
* Any toxicity related to prior treatment must have resolved to Grade 1 or less, with the exception of alopecia
* Clinically significant active infection requiring systemic antibiotic treatment
* Females who are pregnant or breastfeeding
Ondansetron Oral Versus Orally Disintegrating Tablets (ODT)

In children aged 3 months to 10 years who present to the Pediatric Emergency Department (PED) with recent, significant vomiting and moderate dehydration, is treatment with Ondansetron Orally Disintegrating Tablet (ODT) better tolerated than treatment with Ondansetron Oral Solution (OS)? Our hypothesis is that children who receive Ondansetron ODT will have 10% less vomiting within 15 minutes of administration than those receiving Ondansetron OS.

Vomiting related to viral gastroenteritis is the most common presentation to the Alberta Children's Hospital Pediatric Emergency Department. Recently, a clinical pathway was implemented to improve the care and flow of patients with vomiting and/or diarrhea through the department. Administration of an antiemetic, Ondansetron, is an integral part of improving the hydration status of children managed by the pathway. However it is not know whether Oral Solution or Oral Disintegrating Tablets are better tolerated in children who have active vomiting. The investigators aim to show that children receiving Oral Disintegrating Tablets have less vomiting immediately after medication administration than children receiving Oral Solution. By demonstrating this improved tolerability the investigators will provide health care providers the stimulus for implementing Ondansetron Oral Disintegrating Tablets into their practice for children with active vomiting.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 3 months to 10 years with recent,
* significant vomiting and moderate dehydration who are managed according to the Alberta Health Services (Calgary and Area) Acute Childhood Vomiting \& Diarrhea Pathway.
* The following definitions are used to determine inclusion according to the pathway: Recent, significant vomiting - Vomiting at least 6 episodes in the past 6 hours and at least once in the past hour; Moderate dehydration (Gorelick Score 2) - Two of the following: capillary refill time greater than 2 seconds, absence of tears, dry mucous membranes, ill general appearance.

Exclusion Criteria:

* Children who are excluded from the Alberta Health Services (Calgary and Area) Acute Childhood Vomiting \& Diarrhea Pathway.
* These criteria include: Vomiting or Diarrhea for greater than 7 days, Localized abdominal pain, Chronic medical conditions affecting major organ systems (Ex, diabetes, PKU, immunodeficiency), Likely GI Obstruction (abdominal distension, bilious vomiting, absent bowel sounds), Weight less than 8kg. Children who have received anti-emetics at home will not be excluded but will be tracked.
My Diabetes Care Mobile: A Usability Study

The purpose of this study is to conduct a prospective, longitudinal study on the My Diabetes Care mobile (MDC-m) intervention to assess usage patterns, user experience, and to uncover errors in functionality prior to a larger interventional trial.

Up to 65 adult patients with type 2 diabetes mellitus will be enrolled and given access to My Diabetes Care mobile (MDC-m). My Diabetes Care mobile (MDC-m) is a multi-faceted patient portal intervention for mobile devices that is designed to help patients better understand their diabetes health data as well as promote and support self-management. MDC uses infographics to facilitate patients' understanding of their diabetes health data (e.g., HbA1c, LDL), incorporates motivational strategies and access to an online patient support community, and provides literacy level-appropriate and tailored diabetes self-care information. Patients will be invited by mail to be screened for enrollment in the study. Interested patients will be able to complete an electronic consent form and enroll online via Research Electronic Data Capture (REDCap™) version 5.0.8. Study participants will complete questionnaires electronically via email using REDCap™ at two time points: baseline (T0) and one-month follow-up (T1). Participants will complete an baseline questionnaire (T0) including basic demographic questions, items about computer usage and internet access, and validated measures of health literacy and eHealth literacy. Each participant will have access to the MDC-m for 1 month.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 Diabetes Mellitus
* Currently taking at least one medication for diabetes
* Age 21 or over
* Able to speak and read in English
* Reliable access to a smartphone or tablet with internet access
* Active VUMC patient web portal (known as My Health At Vanderbilt) account

Exclusion Criteria:

* Residing in a long term care facility
* Medical condition that affects my memory or ability to think.
* Severe visual impairment
* Patients with unintelligible speech (e.g., dysarthria)
* Currently participating in another diabetes-related research study
Small Stitch Study

A descent of the anterior vaginal wall is the most common form of female pelvic organ prolapse (POP). Although anterior colporrhaphy (AC) is accepted worldwide as a "standard procedure", its exact steps are not well standardized.

We developed a small stitch anterior colporrhaphy (SSTAC) in an effort to increase the strength and durability of AC

Objectives

The aim of this pilot study is to demonstrate the feasibility and complication rate of the SSTAC and to assess the anatomical and functional outcomes after this method of cystocele repair.

A prospective case series evaluation of SSTAC following the recommendations of IDEAL-Collaboration (www.ideal-collaboration.net) will be performed. The newly developed procedure will be tested in a group of 10 patients, who equals stage 2a in the development and innovation of surgical innovations. In this stage safety and technical success is the main outcome. As technical modifications may be common during stage 2a and their nature and timing should be meticulously recorded, the videotaping during all surgical procedures will be performed.

Eligibility Criteria:
Inclusion Criteria:

* women older than 18 years of age
* Able to read, understand and sign informed consent
* symptomatic cystocele described as Points Aa or Ba \>= 0 according to the International Continence Society pelvic organ prolapse quantification system (POP-Q)

Exclusion Criteria:

* previous urogynecological operation
* gynecologic malignancy
* planned concomitant incontinence operation
* other contraindications for surgery
* pregnancy
* systemic glucocorticoid treatment
* contraindication for the surgery
Impact of Atorvastatin Versus Rosuvastatin on 25 Hydroxy Vitamin D Levels in Patients With Acute Coronary Syndrome

there will be 2 groups of patients with acute coronary syndrome. The patients will receive one of the 2 study drugs and impact on raising Vitamin D level will be seen after 6 months

this randomized clinical trial will include 152 patients of acute coronary syndrome with normal Vitamin D levels. they will be randomized to receive either Atorvastatin or Rosuvastatin. After 6 months of therapy, the impact on Vitamin D levels will be checked

Eligibility Criteria:
Inclusion Criteria:

Acute Coronary Syndrome

25 OH-Vitamin D levels between 30-70ng/ml

Exclusion Criteria:

Hypercalcemia

hypocalcemia

pregnancy

lactation

hypersensitivity to statins

hypothyroidism

Deranged LFTs \& RFTs

Use of following within last 3 months (Vitamin D Supplements, lipid lowering drugs, anti-obesity drugs, corticosteroids)
Deep Brain Stimulation for Parkinson's Disease: the Globus Pallidus Internus Versus Subthalamic Nucleus

This study provides an evaluation of 30 patients in 3 years, from the Unified Health System (SUS) irrespective of region of the country, signed with clinical Parkinson's disease in its intermediate stage and that the drug therapy is limited by side effects or beneficial effects provided by prior medication no longer be obtained even at high doses and have therefore the indication for treatment with deep brain stimulation.

The aim of this retrospective study is to compare motor and non-motor (olfactory, pain, cognition and metabolism) symptoms of the effects of deep brain stimulation target to the nucleus globus pallidus versus the subthalamic nucleus in patients with Parkinson´s disease.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a clinical diagnosis of idiopathic Parkinson's disease according to the international criteria that have not responded adequately to treatment with medication or who have complications related to prolonged use of L-dopa.
* Patients who may be in the anesthetized or local or general anesthesia does not incur higher than expected risk in the general population.
* Patients intellectually able to understand and sign the consent form.
* Patients with hematological, metabolic and normal coagulation.

Exclusion Criteria:

* Age below 18 years
* Impossibility to consent to participate in the study.
* Patients during treatment with anti-coagulants or anti-platelet agents.
* Patients with anatomical abnormalities that preclude access to the implantation of electrodes (eg cranial tumors or intracranial or cysts).
* Patients with uncontrolled infection or other medical conditions pre-existing non-controlled (eg decompensated diabetes, hypertension, heart disease or symptomatic air).
* History of primary or secondary myocardial ischemia, congestive heart failure, cardiac arrhythmia or bundle branch block refractory to treatment.
* Concomitant treatment with other experimental drugs.
* Pregnant or lactating.
Bio-marker Analysis Using Circulating Tumor Cells in Patients With Melanoma

This research trial studies the levels of a type of biomarker, circulating tumor cells (CTCs), in the blood of patients with stage I-IV melanoma. A biomarker is a biological molecule found in blood, other body fluids, or tissues that is a sign of a normal or abnormal process, or of a condition or disease. A biomarker may be used to see how well the body responds to a treatment for a disease or condition. Studying samples of blood in the laboratory obtained before and after treatment from patients with melanoma may help doctors learn more about changes that occur in CTC levels and whether they may predict how well patients will respond to therapy.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have signed tissue collection consent as described in protocol IRB# 703001,UPCC# 08607, PI: Giorgos Karakousis, MD
* Subjects must be competent to consent for themselves.
* Subjectsmust be adult (18 years or older).
* Subjects must be initiating a new therapy for melanoma (so a pretreatment CTC count can be obtained).

Exclusion Criteria:

* Children (less than 18yrs)
* Patients in whom a pre-treatment CTC level cannot be obtained.
Liver Glycogen Dynamics

The purpose of this study is to investigate the effect of prolonged overnight fasting in the hepatic glycogen stores


Eligibility Criteria:
Inclusion Criteria:

* Participants are able to provide signed and dated written informed consent prior to any study specific procedures
* Caucasian (people will be excluded when having a ≥50% racial African/Asian background)
* Participants should have suitable veins for cannulation or repeated venipuncture
* Women are post-menopausal (defined as at least 1 year post cessation of menses)
* Men and women aged ≥ 45 and ≤ 75 years at the start of the study
* Body mass index (BMI) 18.5 - 25 kg/m2
* Stable dietary habits (no weight loss or gain \>3kg in the past 3 months)
* Sedentary lifestyle (not more than 3 hours of vigorous sports per week)

Exclusion Criteria:

* Type 2 Diabetes Mellitus
* Active diseases (cardiovascular, diabetes, liver, kidney, cancer or other)
* Any contraindication for MRI scanning
* Alcohol consumption of \>2 servings per day
* Regular smoking
* No use of medication interfering with investigated study parameters (as determined by responsible physician)
* Participants who do not want to be informed about unexpected medical findings, or do not wish that their physician
Effect of Digital Cognitive Training on the Functionality of Older Adults With Mild Cognitive Impairment (MCI)

The purpose of this study is to investigate the effect of digital cognitive training in the functionality of older adults with Mild Cognitive Impairment.

Mild Cognitive Impairment (MCI) is characterized by decline in one or more cognitive domains, including memory, attention, executive functions, language and visuospatial abilities, and in a significant portion of cases may evolve to Alzheimer's Disease. According to established diagnostic criteria, independence for daily life activities is preserved, but activities are carried out less effectiveness and efficiency, affected subjects usually take more time and make more mistakes, when compared to their pre-morbid performance. Different studies have observed that impairments in functional performance in older adults with MCI are associated with impairments in executive function. This study intends to verify the impact of the use of digital cognitive training for executive function on the functionality of older adults with MCI. Digital cognitive exercises, used in the intervention group, have the primary objective of stimulating executive functions, and will be made available through the Internet using the BrainHQ platform. The active control group will play computer games available online. Both groups will play for 1 hour at least 2 times per week.

After baseline assessments, older adults with MCI will be stratified by age, education, gender, functional measurement and cognitive assessment, and randomly assigned to the intervention group with digital cognitive exercises or to the control group with computer games, in a stepped wedge design. Subjects will be evaluated at baseline and after completing 10 and 20 hours of intervention. After the first 10 hours of intervention both groups will be assigned to the intervention with digital cognitive exercises for additional 10 hours. Both groups will be comparable in terms of personal contact with staff and computer time. Our hypothesis is that the training using digital cognitive exercises will improve the executive function and that this gain has a positive impact on the functionality and accomplishment of the daily life activities of older adults with MCI.

Eligibility Criteria:
Inclusion Criteria:

* Age above 65 years old;
* Elderly enrolled in home for aged in wich the research is taking place;
* Montreal Cognitive Assessment above 21 points;

Exclusion Criteria:

* Clinical diagnosis of Alzheimer's Disease;
* Serious medical or neurological condition preventing from participation in the study;
A Study to Assess Safety & Effectiveness of Tovinontrine in Chronic Heart Failure With Reduced Ejection Fraction (Cycle-1-REF)

The purpose of this study is to evaluate the safety and effectiveness of tovinontrine compared to placebo to lower NT-proBNP in patients with chronic heart failure with reduced ejection fraction.


Eligibility Criteria:
Inclusion Criteria:

* Is an adult male or female patient 18 years of age
* Has evidence in the medical history supporting a diagnosis of clinical HF syndrome, NYHA functional class II to III, with the duration of at least 6 months prior to the time of Screening. The HF syndrome is defined by documentation of 1 or more of the following:

  * At least 1 of the typical symptoms due to HF such as dyspnea and/or fatigue limiting exercise capacity;
  * At least 1 of the typical signs of HF such as peripheral edema, elevated jugular venous pressure, pulmonary crackles; or
  * Hospitalization, emergency department visit, or outpatient visit for HF requiring intravenous (IV) or subcutaneous (SQ) diuresis within the past 12 months.
* Has ejection fraction (EF) ≤ 40% by transthoracic echocardiogram (TTE) performed and interpreted locally at the time of Screening;
* Has NT-proBNP level ≥ 600 pg/mL at the time of Screening. Patients with atrial fibrillation or flutter at the time of Screening are required to have an NT-proBNP level of ≥ 1000 pg/mL at the time of Screening;
* Is on stable optimized doses of guideline-directed HF therapy, per Investigator's clinical judgement, for a minimum of 4 weeks prior to the time of Screening and during Screening, with no planned changes after randomization.
* Has had no addition of new guideline-directed HF therapy within the 3 months prior to the time of Screening or during the Screening Period;

Exclusion Criteria:

* Has a documented EF \>40% by TTE within 6 months of the time of Screening or during the Screening Period;
* Has evidence of recent HF exacerbation defined by hospitalization or requirement for IV or SQ diuretics within 60 days of the time of Screening or during the Screening Period;
* Has a requirement for routine, scheduled outpatient IV infusions for HF (ie, inotropes, vasodilators, or diuretics) or routinely scheduled ultrafiltration;
* Has elective interventions (eg, percutaneous coronary intervention, device implantations, percutaneous structural heart disease interventions, cardiac and non-cardiac surgery) planned to occur during involvement in this study;
* Has acute coronary syndrome, stroke, transient ischemic attack, cardiac, carotid or other major cardiovascular surgery, or carotid angioplasty within 60 days of the time of Screening or during the Screening Period;
* Has had a prior or planned orthotopic heart transplantation;
* Has presence of or plan for mechanical circulatory support;

Note: Other protocol defined Inclusion/Exclusion criteria may apply.