cyrilzakka/clinical-trials huggingface dataset:
Health is Power: An Ecological Theory-based Health Intervention for Women of Color

Health Is Power (HIP) was a community based health intervention designed to increase physical activity among women of color. It was funded by a grant from the National Cancer Institute of the National Institutes of Health. The purposes of the study were (1) to determine whether a 6 month, group cohesion intervention is more effective for increasing physical activity compared to a 6 month, group cohesion comparison targeting improving dietary habits (2) to determine whether residence in a neighborhood supportive for physical activity helped women maintain their physical activity from 6 to , and (3) to determine whether this effect was transculturally replicable.

Objective Physical inactivity and poor dietary habits plague Americans as health challenges, with women of color most vulnerable to their detrimental effects. Individually focused interventions have not demonstrated lasting success, possibly due to the lack of focus on sustainable social and physical environment factors. Health Is Power (HIP) was a transcultural, community based, randomized controlled trial that investigated the effectiveness of a group cohesion intervention to increase physical activity in African American and Hispanic or Latina women in Houston and Austin, Texas and then tested whether women living in more supportive areas maintained their physical activity over time. Intervention development was guided by group dynamics principles anchored within an ecologic model. Women participated in three health assessments and a six month face to face intervention that included evidence-based behavioral methods - integrated into strategies to promote group cohesion - framed to account for environmental factors contributing to health disparities. Women participated in team building activities, environmental mapping exercises, and supervised walks or taste tests. Neighborhood contextual and environmental measures were measured to test ecologic factors that may contribute to behavioral maintenance.

Eligibility Criteria:
Inclusion criteria:

* African American or Hispanic/ Latina
* Between the ages of 25 and 60 years old
* Able to read, speak, and write in English or Spanish
* Not pregnant or planning to become pregnant within the next 12 months
* Resident of Harris or Travis County, Texas
* Not planning on moving in the next 12 months
* Physically inactive or did not do more than 30 min of physical activity per day on 3 or more days per week
* No history of medical illness or currently taking medication (could have medical waiver from physician if did not meet this)
* Willing to be randomized to either a physical activity group or a vegetable and fruit group
* Available between 5:30 and 8:00 PM on meeting dates.
Mechanistic Evaluation of Response in TRD (MERIT)

To evaluate the relapse prevention of AXS-05 relative to placebo in subjects with treatment resistant depression (TRD).

This is a randomized, double-blind, placebo-controlled study to evaluate AXS-05 compared to placebo in delaying relapse of depressive symptoms in patients with TRD who are in stable remission after treatment with AXS-05.


Eligibility Criteria:
Key Eligibility Criteria:

* Ongoing symptoms of depression despite receiving treatment with two or more prior antidepressants during the current major depressive episode, prior to receiving AXS-05
* Agree to use adequate method of contraception for the duration of the study
* Additional criteria may apply
A Study in Normal Healthy People, Testing Different Versions of a Pill That Will be Used to Treat Rheumatoid Arthritis.

The study will try, in 2 separate parts, each using 12 research subjects, to see how a new form of the pill CE 224,535 gets released into the bloodstream and whether that is affected by food. In each part, subjects will switch among 4 treatment periods to take either different forms of the pill(s) or the same form either after fasting or eating a meal. The second part will only happen depending on whether the sponsor believes it is needed and will use separate subject than the first part.


Eligibility Criteria:
Inclusion Criteria:

* aged 18-55 and healthy

Exclusion Criteria:

* severe chronic or uncontrolled medical or psychiatric conditions, including drug abuse
* pregnant or wanting to become pregnant
BMS-247550 in Treating Patients With Stage IV Melanoma

Phase II trial to study the effectiveness of BMS-247550 in treating patients who have stage IV melanoma. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die

OBJECTIVES:

I. Determine the efficacy of BMS-247550 in patients with stage IV melanoma. II. Determine the toxicity of this drug in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to the number of prior chemotherapy regimens (0 vs 1-2, including dacarbazine or temozolomide).

Patients receive BMS-247550 IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed stage IV melanoma
* At least 1 measurable lesion

  * Greater than 20 mm by conventional techniques
  * Greater than 10 mm by spiral CT scan
* Known brain metastases allowed if all of the following criteria are met:

  * Radiologically stable for at least 6 weeks after completion of whole brain radiotherapy
  * Stable at time of study
  * No mass effect present radiologically
  * No concurrent steroids to control symptoms of brain metastases
* Performance status - ECOG 0-2
* Performance status - Karnofsky 60-100%
* At least 3 months
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Bilirubin normal
* AST/ALT no greater than 2.5 times upper limit of normal (ULN)
* Creatinine no greater than 1.5 times ULN
* No symptomatic congestive heart failure
* No unstable angina pectoris
* No cardiac arrhythmia
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No prior severe allergic reactions (grade III or IV or grade II not responsive to steroids) to taxanes or medications containing Cremophor EL
* No pre-existing grade 2 or greater peripheral neuropathy
* No HIV-positive patients receiving combination antiretroviral therapy
* No other concurrent uncontrolled illness
* No ongoing or active infection
* No psychiatric illness that would preclude study
* Prior vaccine therapy allowed
* Prior immunotherapy (e.g., interleukin-2 or interferon) allowed
* Stratum I:

  * No prior chemotherapy
* Stratum II:

  * No more than 2 prior chemotherapy regimens (must have included dacarbazine or temozolomide)
* See Disease Characteristics
* See Disease Characteristics
* Prior limb-perfusion therapy allowed (stratum II)
* No other concurrent investigational or commercial agents or therapies intended to treat malignancy
* No concurrent Hypericum perforatum
Virtual Reality Pain Control During Burn Wound Care

Using Virtual Reality as a form of Distraction during Burn Care.

The purpose of the study is to investigate the effectiveness of virtual reality (a form of distraction) in order to reduce patients' procedural burn pain.

Eligibility Criteria:
Inclusion Criteria:

* Able to complete subjective evaluations of pain
* English-speaking
* Not demonstrating delirium, psychosis, or any form of Organic Brain Disorder
* Able to communicate orally

Exclusion Criteria:

* Incapable of indicating subjective evaluation of pain
* Non-English-speaking
* Severe head or neck injury or other medical conditions that prohibit patient from wearing VR helmet
* Demonstrating delirium, psychosis, or Organic Brain Disorder
* Unable to communicate verbally
* Significant developmental disability
* Extreme susceptibility to motion sickness
* Reports having no problem with pain during wound care.
Angina, Physiology, Biology (ANgina, FIsiologia BIOlogia)

Relationship between invasive physiological assessment with FFR and IMR and biological markers as micro-RNA's according to coronary vascular compartiment affected (Group 1: Macrovasculature + / Microvasculature +; Group 2: Macrovasculature + / Microvasculature -; Group 3: Macrovasculature - / Microvasculature +; Group 4: Macrovasculature - / Microvasculature -). Also, biological markers will be related with presence of microvascular spasm or macrovascular spasm (Group 5).

Patients with chest pain suggestive of angina after ruling out other cardiac and non-cardiac causes, referred for invasive coronary angiography, will be evaluated by coronary angiography and invasive coronary physiological assessment by determining FFR and IMR and by performing a vasoreactivity test with acetylcholine.

A relationship will be established between the invasive physiological assessment with FFR and IMR and biological markers such as micro-RNA's according to the affected coronary vascular compartment (Group 1: Macrovasculature + / Microvasculature +; Group 2: Macrovasculature + / Microvasculature -; Group 3 : Macrovasculature - / Microvasculature +; Group 4: Macrovasculature - / Microvasculature -). In addition, the biological markers will be related to the presence of microvascular spasm or macrovascular spasm (Group 5).

Finally, among other biological markers, the following miRNAs will be compared. These miRNA's present consistent data in the literature about their over or underexpression.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years.
2. Patients with chest pain suggestive of angina evaluated by a cardiologist referred for diagnostic coronary angiography and possible coronary intervention.
3. Echocardiogram ruling out noncoronary cardiac causes of chest pain.
4. Informed consent.

Exclusion Criteria:

1. Contrast allergy not susceptible to premedication.
2. Severe bronchial asthma or adenosine intolerance.
3. Atrio-ventricular block (≥ 2nd degree) or acetylcholine intolerance.
4. Acute myocardial infarction with ST-segment elevation.
5. Acute myocardial infarction without ST-segment elevation.
6. Cardiogenic shock.
7. Total occlusion of any coronary artery that precludes measurements with pressure-temperature guidewires.
8. Previous coronary artery bypass grafting.
9. Women with the possibility of being pregnant.
10. Renal dysfunction with an estimated glomerular filtration rate \<30 mL/min/1.73m2.
11. Inability to understand the nature of the study and / or sign informed consent.
12. Any other medical condition that, in the opinion of the researcher, may lead to safety issues for patients or may alter the results of the study.
MMR/MSI Phenotypes in Prediction of Tumor Vaccine Benefit for Gliomas

Glioblastoma (GBM) is the most malignant primary intracranial tumor with a median survival of about 18 months, and new therapies are urgently needed. Tumor vaccines has been shown to improve survival of GBM, but not all patients can benefit from vaccine treatment and biomarkers are urgently needed. Deletion of mismatch repair (MMR) protein and microsatellite instability (MSI) state are important features in the biological evolution of GBM, and may be used as markers for tumor vaccine. Therefore, this project will collect samples from GBM patients before and after vaccine treatment respectively, and evaluate the role of MMR/MSI gene phenotype in predicting vaccine efficacy and the potential molecular mechanism. Moreover, MMR/MSI phenotypes will be assessed by deep-learning and radiomics using images to establish noninvasive markers for vaccine.


Eligibility Criteria:
Inclusion Criteria:

The patients with glioma in the Department of Neurosurgery of Huashan Hospital Affiliated to Fudan University who meet the following three conditions can be enrolled

1. They were 18-80 years old, male and female;
2. The pathological results of frozen section during operation were gliomas (20 cases of who grade II, II and IV, respectively);
3. Tissue (6 mm \* 6 mm) can be used for cell sorting on the basis of not affecting clinical routine diagnosis;
4. Sign informed consent.

Exclusion Criteria:

Patients who meet any of the following criteria will not be included in this study:

1. Participants in other clinical trials;
2. Pregnant women.
Safety of Same Day Discharge After Elective Percutaneous Coronary Intervention

Study intends to determine if there is any difference in the occurrence of major adverse cardiology events in patients discharged on the same day as their elective cardiac angioplasty or discharged one day after their angioplasty.

Hypothesize that same day discharge is as safe as a day later discharge.


Eligibility Criteria:
Inclusion Criteria: :

* Low risk lesion (according to the ACC classification)
* Normal Pre Catheterization laboratory investigation
* Procedure performed before 3 pm
* procedure performed with ≤ 6 French guiding Catheter
* EF ≥ 35%
* living at a distance of within 15 kilometers from hospital
* caregiver present at home
* elective procedure

Exclusion Criteria:

* Acute PCI
* high risk lesions (according to the ACC classification)
* deranged Pre Catheterization laboratory investigations
* Age \>70
* Severe LV dysfunction, CVA
* procedure to be performed with a guiding catheter \>6F
* Use of IIb/IIIa inhibitor
* Creatinine clearance of \< 50
Biomarkers and Mechanisms of Disease Progression and Outcome of Aortic Stenosis in Humans

Biomarkers and mechanisms in the progression of aortic valve stenosis are sometimes not sufficiently understood. The current project will take into account image morphological and immunological aspects that predict the development of hemodynamically relevant aortic valve stenosis in order to identify high-risk patients and to develop further therapeutic options.

Early recognition and management of aortic stenosis (AS) are substantial to avoid life threatening events during the clinical course. Multi-factorial complex mechanisms including fibrosis, oxidative stress, inflammation, angiogenesis, osteogenic differentiation and the effect of genetic risk variants have been proposed to be involved mechanistically in the pathogenesis of degenerative AS. It is crucial to identify the potentially involved mechanisms of AS progression in order to 1) identify patients at risk for pronounced cardiac damage and adverse outcomes that might benefit from early aortic valve replacement and 2) to discover treatment options that might slow down progression and lower adverse clinical events.

The consortium´s work has revealed that various inflammatory events play a substantial role for the onset and progression of aortic valve calcification and stenosis in cell culture and small animal experiments We hypothesize that patients with and without rapid progress to severe aortic stenosis differ in terms of genetic, immunological and imaging parameters early in the disease course, and that these parameters can be combined to create strong and reliable predictors of disease progression. Hence, we plan to assess multiple morphological, functional, genetic and immunological readouts and investigate their capacity to predict disease progression in AS in a clinical observational cohort of 938 patients with moderate AS.

This project is a working package as part of TRR259, which is a collaborative project between the three universities: Bonn, Cologne and Düsseldorf.

Eligibility Criteria:
Inclusion Criteria:

* The patient has an acquired (tricuspid) moderate aortic valve stenosis, which is the reason for regular outpatient cardiological care.
* The subject has been informed verbally and in writing about the study and has given written consent to participate in this study.
* Age \> 18 years

Exclusion Criteria:

* The subject has contraindications for the performance of a magnetic resonance imaging or computed tomography (e.g., severe arrhythmias , contrast agent intolerance, a pacemaker, or severe renal insufficiency or severe renal insufficiency or claustrophobia).
* Presence of only mild or already high-grade acquired tricuspid Aortic valve stenosis
* Patient with bicuspid aortic valve
* Inability to follow the instructions of study personnel
* Lack of written informed consent
Effects of a New Combination of Nutraceuticals (AkP06) Without Monacolin K on Plasma Lipids and Glucose

The study is designed evaluate the effects of a new combination of nutraceuticals (AkP 06) without Monacolin K on lipid and glucose metabolism.

The study will analyze the impact of 4 weeks treatment with Akp06 or placebo, according to a randomized scheme, on metabolic parameters in dyslipidemic subjects that do not require or not tolerate a statin therapy. In particular, it will assess the ability of AkP 06 to reduce the plasma levels of LDL cholesterol, HbA1C, glicaemia and fasting insulin and to increase those of HDL cholesterol.

In addition, effects on serum transaminase and creatine phosphokinase (CPK) concentration will be evaluated.

The experimental design involves the construction of a placebo-controlled, randomized, single-blind, parallel-groups.

Patients with mild hypercholesterolemia, of both sexes and aged between 18 and 75 years, will be recruited, from the beginning of the study and for the next 2 weeks at the outpatients Hypertension Clinic.

The subjects will be enrolled in the 50/50% male/female ratio ± 10% comparable for age, in order to obtain a proper comparison between groups with similar demographic characteristics or not statistically different.

The subjects, selected on the basis of inclusion and exclusion criteria, will be divided into two groups, to a computer based randomization scheme to receive one of two different treatments, two tablet/day before meals of the new nutraceutical AkP06 (Akademy Pharma) containing Morus Alba and without Monacolin K, vs. two tablet/day of placebo, always before meals. During the first two weeks both groups will follow the prescribed diet and assume placebo tablets. At the end, blood tests (traditional metabolic parameters, blood glucose, HbA1C, fasting insulin, transaminase levels, CPK) will be performed. During the next 4 weeks a group will assume AkP06 (Akademy Pharma) containing Morus Alba and without Monakolin K, the other will assume placebo and everyone will continue to follow the prescribed diet. At the end of this period blood tests will be repeated. Tablets of AkP06 and placebo will be provided by Akademy Pharma free of charge

Eligibility Criteria:
Inclusion Criteria:

* Total Cholesterol\<300 mg/dL
* Total Cholesterol\>200 mg/dL
* Cardiovascular Risk\<20%

Exclusion Criteria:

* Pregnancy
* Documented intolerance to one or more components of AkP06
* Previous cardiovascular events
* Familiar severe dyslipidemia
* Familiar high cardiovascular risk Hepatic or muscular disorders Subjects receiving lipid-lowering drugs
Management of Lower Pole Renal Hard Stones ≤2 cm

The study has been conducted in Urology department at Kafrelsheikh University Hospital between March 2022 to March 2023. informed consent was taken from eligible patients and were randomized into three groups, Group A :Flexible ureteroscope (F-URS) group underwent holmium laser lithotripsy using flexible ureteroscopy (Boston® scientific (lithovue) while, Group B : extracorporeal shock wave lithotripsy (ESWL) group underwent electromagnetic extracorporeal shock wave lithotripsy (STORZ® MEDICAL Modulith SLX-F2 FD21, Germany) .Group C : Mini perc group underwent holmium laser lithotripsy using Karl® Storz MIP set.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient older than 18 years.
* single renal stone.
* medium sized Stone up to 2.0 cm .
* Do novo
* Stone in lower calyceal stone
* Hard stone

Exclusion Criteria:

* • multiple renal stones

  * stone size \> 2 cm
  * age group \< 18
  * solitary kidney
  * Patients with BMI \> 40 kg/m2
  * bleeding disorders
  * anatomical renal abnormalities
  * Obstruction distal to the stone.
  * Musculoskeletal deformities
Trial of Safety and Tolerability of Oral Verdinexor (KPT-335) in Healthy Adults

This is a randomized, double-blind, sequential, dose-escalation, Phase 1 trial to evaluate the safety and tolerability of verdinexor. Verdinexor or placebo will be given on Days 1 and 3 to healthy adult participants.

This is a randomized, double-blind, sequential, dose-escalation, Phase 1 trial to evaluate the safety and tolerability of verdinexor. Verdinexor or placebo will be given on Days 1 and 3 to healthy adult participants.

Cohorts of 8 participants each (6 active, 2 placebo) will be sequentially administered verdinexor or placebo (one dose on Day 1 and one dose on Day 3) using a dose-escalation scheme. A conservative, sequential, dose-escalation strategy employing decreasing escalation increments will be used.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be in good health as determined by the investigator, based on the medical history, ECG, physical examination, and safety laboratory tests at screening.
* Participants must be identified as a non-smoker at the screening visit (a non-smoker is defined as an individual who has abstained from smoking for at least 1 year prior to the screening visit and who has a ≤ 15 pack year history of lifetime cigarette use). A urine cotinine test will be performed at screening and at the time of clinic check-in prior to study drug treatment.

Exclusion Criteria:

* The participant has any surgical or medical condition that potentially may alter the absorption, metabolism, or excretion of the study drug such as gastrectomy, Crohn's disease, or liver disease.
* The participant has a history of clinically significant allergies. Hay fever is allowed unless it is active or has required treatment within the previous 2 months.
* Presence of a chronic condition(s) with clinical or historical evidence of recent exacerbation, or other information to suggest non-control of such condition(s).
* History of alcohol abuse or drug addiction within 12 months of the screening visit.
* Any participant with active cataracts or medical history of cataracts.
Effect of Multiple Doses of AZD6280 on the Pharmacokinetics of Midazolam (CYP3A4) and Caffeine (CYP1A2)

The aim of this study is to investigate the effects of taking repeated doses of AZD6280 on the blood levels of midazolam and caffeine in healthy volunteers


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects aged 18 to 45 years (inclusive) on Day 1.

Exclusion Criteria:

* Clinically relevant abnormalities in physical examinations, vital signs, clinical chemistry, hematology or urinalysis as judged by the investigator and/or sponsor.
* Enrollment in another concurrent investigational study or intake of an investigational drug within 3 months or intake of an investigational drug within a period of 5 half lives of that drug prior to the screening visit