cyrilzakka/clinical-trials huggingface dataset:
Cognitive Priming for Stroke Tele-rehabilitation

The goal of this pilot study is to investigate whether adding cognitive rehabilitation to an existing occupational therapy (OT) stroke telerehabilitation program will improve stroke survivors' functioning. The main question it aims to answer is whether this intervention improves cognition, participation, upper extremity use in real-world activities, and mood/quality of life. Participants will be asked to engage in an 8-week stroke tele-rehabilitation program (13 sessions), which includes both cognitive rehabilitation and OT for arm/hand function, and complete assessments before and after the intervention.


Eligibility Criteria:
Inclusion Criteria:

* Have experienced ischemic or hemorrhagic stroke with resultant paresis of one arm/hand at least 30 days prior
* Adults ages 21 years or older
* Are able to speak and read English
* Have corrected vision to be able to read text on a screen
* Have a device on which a telerehabilitation visit can be conducted (i.e., phone, tablet, or laptop) and a Wi-Fi connection or cellular service
* Able to participate in the study's assessment sessions as per the judgment of the licensed, experienced stroke telerehabilitation occupational therapist.

Exclusion Criteria:

* Have moderate-severe or severe aphasia.
* Have impaired decision making capacity as determined by a standard protocol for assessing capacity to provide informed consent.
Phase II Randomized Placebo-controlled Study With Vitamin K2 in Asymptomatic Calcified Carotid Stenosis

Randomized placebo-controlled study with vitamine K2 (Menaquinone-4) in calcified carotid stenosis. We evaluate the plaque remodelling after administration of vitamine, reducing the calcified component.


Eligibility Criteria:
Inclusion Criteria:

* carotid stenosis between 50 and 70% (NASCET criteria) with calcified plaque

Exclusion Criteria:

* renal and/or hepatic failure
* diseases with secondary calcifications
* dementia
* previous strokes
* concomitant use of anticoagulants
* concomitant infections
* pregnancy or breastfeeding
* reduced patient's compliance
LivQ-box® Parameters in the Diagnosis of Liver Inflammation

To evaluate the correlation between LivQ-box® parameters carried by iLivTouch and liver inflammation in patients with NAFLD, as well as the diagnostic value of liver inflammation of different severity levels.

This study is a multi-center study that retrospectively analyzed and prospectively included 240 NAFLD patients in total who met the inclusion criteria. The laboratory, iLivTouch, and liver biopsy results were collected to evaluate the correlation between LivQ-box® parameters carried by iLivTouch and liver inflammation in patients with NAFLD, as well as the diagnostic value of liver inflammation of different severity levels. In the end, cut-off values for different stages of inflammation were obtained.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with NAFLD according to The diagnosis and management of nonalcoholic fatty liver disease: Practice guidance from the American Association for the Study of Liver Diseases;
* Age over 18 years old, gender not limited;
* Not combined with liver diseases (such as viral hepatitis, drug-induced liver injury, autoimmune liver disease);
* Perform iLivTouch examination within ± 14 days of liver pathology examination;
* No history of excessive alcohol consumption (converted to ethanol:\<140g/week for males,\<70g/week for females);
Safety of 25 and 50 mg Proellex® in the Treatment of Women With Symptomatic Uterine Fibroids

Safety and efficacy study of 25 and 50 mg doses of Proellex

The study is intended to provide more abundant safety and efficacy data of both the 25 and 50 mg doses of Proellex than ZPU-301, ZPU-302, ZPU-303 and ZPU-304 alone.

Eligibility Criteria:
Inclusion Criteria:

* At least 1 uterine fibroid must be identifiable and measurable by Transvaginal Ultrasound (TVU)
* Subject has a menstrual cycle lasting from 20 to 40 days.
* Subject must have satisfactorily completed all study visits from the previous study in which she participated: ZPU-301, ZPU-302, ZPU-303, or ZPU-304

Exclusion Criteria:

* Subjects who have not participated in 1 of the previous Repros studies: ZPU-301, ZPU-302, ZPU-303, or ZPU-304.
* Subjects who met treatment stopping rules as per the DILI Guidance requirements while participating in ZPU-301, ZPU-302, ZPU-303, or ZPU-304
Cholesterol and Pharmacogenetic Study

The overall objective of the CAP study was to determine genetic influences on efficacy of simvastatin treatment with regard to LDL cholesterol reduction and changes in other markers of cardiovascular disease risk.

Despite widespread use of statin therapy for reducing risk of cardiovascular disease risk, there is considerable inter-individual variation in statin efficacy, and it would be desirable to identify markers that would be predictive of the magnitude of beneficial response. The effect of statin most strongly associated with improved clinical outcomes is reduction in LDL cholesterol. The CAP study was a six week non-randomized, open label study of simvastatin 40 mg/day in a group of 335 African-American and 609 Caucasian volunteer subjects. Measurements of plasma lipids and lipoproteins, as well as other markers of cardiovascular disease risk, were obtained at the screening and entry visits, and after four and six weeks of simvastatin treatment. Both baseline measurements and changes in response to simvastatin therapy are being used to test for associations with genetic polymorphisms. Significant findings are being replicated in other study cohorts.

Eligibility Criteria:
Inclusion Criteria:

* at least 30 years of age
* Total Cholesterol between 160 to 400 mg/dl
* \> 3 grandparents of African-American descent or \> 3 grandparents of Caucasian descent
* serum triglycerides \< 400 mg/dl
* fasting glucose \< 126 mg/dl

Exclusion Criteria:

* Use of lipid-lowering medication
* Use of over-the-counter products containing sterol or stanol esters or fish oil
* Recent or planned change in dietary intake or weight change of more than 4.5 kg
* Use of corticosteroids, immunosuppressive drugs or drugs affecting the CYP3A4 system
* Known liver disease or elevated transaminase levels
* Elevated creatine phosphokinase levels \> 10 times upper limits of normal
* Uncontrolled blood pressure, or diabetes mellitus
* Abnormal renal or thyroid function
* Current alcohol or drug abuse
* Major illness in the preceding three months
* Pregnancy
* Know intolerance to statins
* Racial ancestry other than African-American or Caucasian
Study of Dehydroepiandrosterone Treatment for Poor Responders in In Vitro Fertilization Patients

The aim of this study is to show solid evidences of the efficacy of DHEA in improving the success rates of in-vitro fertilization (IVF) patients facing poor ovarian reserve.

Poor responders to IVF treatment occurs in 5-24% of in-vitro fertilisation (IVF) cycles, resulting in the cancellation of the cycle translating in very low pregnancy rate. Current interventions based upon the use of different stimulation regimen do not address the fundamental underlying physiological basis of follicular recruitment and development.

The over-riding objective of this proposal is to devise novel therapeutic approaches to the treatment of poor responders of IVF treatment through dietary supplementation with Dehydroepiandrosterone (DHEA). The investigators hypothesise that DHEA supplementation leads to improvements in ovarian steroidogenesis in poor responders, leading to improved IVF outcome. Specifically, the investigators aim to

1. Conduct a prospective randomised controlled trial (RCT) on the effects of DHEA supplementation in women who are poor responders to IVF treatment.
2. Investigate the effects of DHEA supplementation on ovarian steroidogenesis and biochemical and ultrasonographic markers of ovarian reserves.

Eligibility Criteria:
Inclusion Criteria:

* All women who meet one of the two following Bologna criteria for poor responder: an abnormal ovarian reserve test (AMH \<1.0 ng/mL or FSH \>10 IU/L ), or where fewer than 4 oocytes were retrieved or fewer than 4 follicles were observed in a previous IVF stimulation cycle with either standard long or antagonist protocols
* Where informed consent can be obtained

Exclusion Criteria:

* Previous or current DHEA supplementation
* Previous and current use of corticosteroids
* Major systemic illnesses
* Allergy to DHEA
An EEG Study on the Rhythmic Nature of Perception and Attention

The study involved healthy volunteers (n= 200), in a single center, low-risk intervention protocol of a non-profit nature. The objective of the study is to investigate the neural mechanisms of visual perception and attention, with particular reference to neural oscillations, in the general population through electroencephalogram (EEG) recording and the administration of simple visual tasks on a PC. The study presented is not associated with risks, as EEG is a non-invasive technique for which there are no known contraindications or adverse reactions.


Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 35 years
* able/willing to sign the informed consent
* normal or corrected-to-normal vision and hearing

Exclusion Criteria:

- history of severe/major neurological or psychiatric conditions
Phase II Study of Teriflunomide as Adjunctive Therapy to Interferon-beta in Subjects With Multiple Sclerosis

The primary objective was to estimate the tolerability and safety of 2 doses of teriflunomide administered once daily for 24 weeks, compared with placebo, in patients with multiple sclerosis \[MS\] with relapses who were on a stable dose of interferon-β \[IFN-β\].

Secondary objectives were:

* to estimate the effects of the 2 doses of teriflunomide, compared to placebo, in combination with a stable dose of IFN-β on Magnetic Resonance Imaging \[MRI\] parameters, relapse rate and patient-reported fatigue;
* to perform pharmacokinetic analyses of the 2 doses of teriflunomide in combination with a stable dose of IFN-β.

The study period per participant was approximatively 44 weeks broken down as follows:

* Screening period up to 4 weeks,
* 24-week double-blind treatment period\*,
* 16-week post-treatment elimination follow-up period.

'\*' participants successfully completing the week 24 visit were offered the opportunity to enter the optional long-term extension study LTS6047 - NCT00811395.

Eligibility Criteria:
Inclusion Criteria:

* Definite MS diagnosis according to McDonald's criteria;
* Relapsing clinical course, with or without progression;
* Expanded Disability Status Scale \[EDSS\] less or equal to 5.5 (ambulatory);
* Stable dose of IFN-β for at least 26 weeks prior to the screening visit;
* No onset of MS relapse in the preceding 60 days prior to randomization;
* Clinically stable for 4 weeks prior to randomization.

Exclusion Criteria:

* Other chronic disease of the immune system, liver function impairment or chronic pancreatic disease;
* Pregnant or nursing woman;
* Alcohol or drug abuse;
* Use of cladribine, mitoxantrone, or other immunosuppressant agents such as azathioprine, cyclophosphamide, cyclosporin, methotrexate or mycophenolate before enrollment;
* Human immunodeficiency virus \[HIV\] positive status;
* Any known condition or circumstance that would prevent in the investigator's opinion compliance or completion of the study.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
ELEKT-D: Electroconvulsive Therapy (ECT) vs. Ketamine in Patients With Treatment Resistant Depression (TRD)

The goal of the study is to conduct a comparative randomized trial of electroconvulsive therapy (ECT) vs. ketamine for patients with treatment resistant depression (TRD) in a real world setting with patient reported outcomes as primary and secondary outcome measures.

Patients with treatment resistant depression who meet all inclusion criteria and do not meet any exclusion criteria will be randomized to either electroconvulsive therapy (ECT) three times per week or ketamine infusion two times per week. Patients will answer questionnaires about their symptoms prior to treatments. The acute treatment phase of the study will last three to five weeks. Depending on response to treatment, some patients will be followed for an additional six months.

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent before any study related procedures are performed
2. Inpatients or outpatients referred by their providers for ECT treatment and eligible for ECT treatment
3. Males/females at least 21 years of age but no older than 75 years of age
4. Meet DSM-5 criteria for Major Depressive Episode as determined by both:

   A. a clinician's diagnostic evaluation and B. confirmed with the MINI International Neuropsychiatric Interview (MINI 7.0.2)
5. A current depressive episode that has lasted a minimum of 4 weeks
6. Meet all of the following criteria on symptom rating scales at screening:

   A. Montgomery Asberg Depression Rating Scale (MADRS) score \>20 B. Young Mania Rating Scale (YMRS) of ≤ 5 C. Montreal Cognitive Assessment (MoCA) of ≥18
7. Have had ≥2 adequate trials of antidepressants or augmentation strategies during their lifetime. An adequate trial is defined as 4 weeks of medication at the minimum FDA approved dose. This will be equal to a trial rating of 3 or more.
8. In the opinion of the investigator, the patient is willing and able to comply with scheduled visits, treatment plan, and other trial procedures for the duration of the study

Exclusion Criteria:

1. Meet DSM-5 criteria for bipolar disorder, schizophrenia, schizophreniform disorder, schizoaffective disorder, mental retardation, or pervasive developmental disorder
2. Meets any exclusion criteria for ECT or ketamine treatment as described in the clinical guidelines or according to investigator judgment
3. The patient is pregnant or breast feeding
4. The patient has a severe medical illness or severe neurological disorder
5. The patient has a known ketamine allergy or is taking a medication that may interact with ketamine
6. Diagnosis of major depressive disorder with psychotic features during the current depressive episode
7. Unable to give informed consent
8. Was previously enrolled/randomized into the trial
Matrix Metalloproteinase (MMP) in Heart Failure

The purpose of this study is to evaluate the production of MMP in failing hearts.

Myocardial fibrosis is observed in failing hearts and parallel to the progression of chronic heart failure (CHF) and myocardial remodeling. Matrix metalloproteinases (MMPs) are considered markers of fibrosis. Recently, circulating MMPs can be measured and are elevated in patients with CHF. However, MMPs it is still unclear whether MMPs are produced in failing hearts. Thus, the purpose of this study is to evaluate the production of MMP in failing hearts.

Eligibility Criteria:
Inclusion Criteria:

* chronic stable heart failure
A Study to Evaluate the Quality of Life of Male and Female Adult Patients With Severe Refractory Atopic Dermatitis Treated With Dupilumab in Czech Republic

Assessment of the relationship between treatment response (EASI75) and change in quality of life (EQ-5D) by week 24.

Description of the:

* Change in disease activity after 16 and 24 weeks
* Change in subject and family quality of life after 16 and 24 weeks
* Change in sleep quality after 16 and 24 weeks
* Change in anxiety after 16 and 24 weeks
* Change in depression after 16 and 24 weeks
* Safety and tolerability

28 weeks

Eligibility Criteria:
Inclusion Criteria:

* Patient eligible for Dupixent therapy of AD according to the current SPC and reimbursement criteria given by the SUKL
* Signed informed consent
* 18 years and older (study questionnaires are validated for this age group). Patient is able to follow the prescribed regimen, routine follow-up visits and to fill the questionnaires

Exclusion Criteria:

- Patient not eligible for Dupixent therapy of AD according to the current SPC and reimbursement criteria given by the SUKL.

The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Dietary Fish and Omega 3 Fatty Acids for Breast Cancer Prevention

Research studies show that the type of fat in the diet may affect breast cancer risk. Fish oil and fish contain increased amounts of omega 3 fatty acids which appear to stop or slow down the growth and development of breast cancer cells in laboratory studies of mice and breast cancer cells. The use of omega 3 fatty acids to reduce the risk of breast cancer development in humans has not been adequately studied. Eating fish or taking fish oil may increase the amount of omega 3 in the breast, which may lower one's risk of breast cancer development.

Persons in this study with do one of the following: (1) take two capsules daily of omega 3 fatty acid supplements, or (2) eat several servings of canned salmon / tuna per week for a total of three months. Amounts of omega 3 fatty acids in the body's tissues will be measured by blood tests and a small sample of breast fat as obtained by a fine needle aspiration.

This study is supported by funding from the National Fisheries Institute, Food Innovation Center of The Ohio State University, and The Ohio State University Comprehensive Cancer Center.

The primary objectives of this study are to:

i.) Determine the effects of increased fish consumption on serum and breast fat tissue fatty acids in women at high risk for developing breast cancer relative to an omega 3 fatty acid supplement;

ii.) Assess adherence and tolerability of increased dietary intake of fish relative to an omega 3 fatty acid supplement.

Secondary objectives include:

iii.) Evaluate possible correlations between physical factors such as body mass index (BMI) and dietary factors and target tissue effects.

iv.) Explore additional biomarkers as surrogate endpoints to measure effects of fish consumption.

Eligibility Criteria:
Inclusion Criteria:

* Increased risk for breast cancer based on family history, personal history
* Normal mammogram, clinical breast examination in the past 12 months
* \>1 year from pregnancy, lactation or chemotherapy

Exclusion Criteria:

* Concurrent malignancy or metastatic malignancy of any kind
* History of a bleeding tendency, use of anticoagulant medications
* Inability to undergo fine needle aspiration of breast adipose tissue
* Chronic use of omega-3 fatty acid supplements or regular consumption of \> 2 meals/servings of fish per week within the 3 months prior to entry on the study or any other supplements that might interact with omega-3 fatty acid supplements
* Known sensitivity or allergy to fish
* Standing regimen of full dose aspirin (325 mg/day or more), Non-steroidal anti-inflammatory drugs (NSAIDs) or NSAID-containing products.
Radical Hypofractionated Radiotherapy for Localized Prostate Cancer

The aim of this trial is to study the safety outcomes of hypofractionated radiotherapy in treating patients with localized prostate cancer.

Hypofractionated radiotherapy delivers higher doses of radiotherapy in a shorter time period, may enabling the killing of more tumor cells with fewer side effects.

Accumulating evidence has proven the safety and feasibility of hypofractionated radiotherapy for localized prostate cancer.But for localized prostate cancer,the optimal dose per fraction of hypofractionated radiotherapy is still on its way.

The present study will be conducted as a prospective, open-label, single-arm clinical trial.

The patients will receive hypofractionated radiation(54 Gy in 15 daily fractions of 3.6 Gy ). After completion of study treatment, patients were followed up once a month for the first 3 months and once every 3 months after 3 months for a total of 5 years.

The primary endpoints of the study are the toxicities about gastrointestinal (GI),genitourinary (GU) symptoms and erectile dysfunction.The secondary endpoints include progression-free survival (bPFS), local progression-free-survival(LPFS) ,distant metastasis free survival(DMFS) ,overall survival (OS)and quality of life (QoL).

Eligibility Criteria:
Inclusion Criteria:

* Age: ≥18 years old;
* European Cooperative Oncology Group score(ECOG):≤ 2;
* Patients with pathologically diagnosed prostate cancer;
* Clinical stage was cTanyN0M0 any Gleason / ISUP group;
* Expected survival time \>5 years;
* The patient has no contraindications to radiotherapy and is suitable and willing to undergo radiotherapy;
* Patients who voluntarily accept the experimental study protocol after being informed about the existing treatment options;

Exclusion Criteria:

* Patients who have received any other early treatment for prostate cancer, including radiotherapy, chemotherapy, focal therapy, etc;
* a previous history of pelvic and abdominal radiotherapy;
* Prior hormonal therapy (castration or antiandrogen);
* Patients with other malignancies and acute or chronic infections such as human immunodeficiency virus (HIV) (+), hepatitis C virus (HCV) (+) and/or positive syphilis;
* Patients that the investigator considers unsuitable to participate in the clinical trial; patients with other serious systemic diseases, evaluation and compliance of the trial, including severe respiratory, circulatory, neurological, mental, digestive, endocrine, immune, urinary, and other systemic diseases;
* Patients with contraindications related to radiotherapy;
* Participate in other clinical trials that are mutually exclusive with the study intervention within 4 weeks prior to the start of the study;
* Patients unable to provide written informed consent or demonstrate poor treatment compliance
iStent Inject Trabecular Micro-Bypass System Continuation Post-Approval Study

Long term follow up of subjects in the IDE study for iStent Inject to monitor safety

To evaluate the long -term rate of clinically relevant complications associated with iStent inject® placement and stability in subjects who have completed participation of the IDE clinical trial (GC-008).

Eligibility Criteria:
Inclusion Criteria:

* Randomized subject followed for 24 months in the GC-008 study
* Able to understand study requirements
* Willing to attend scheduled follow-up exams for 5 years post-operatively
* Able and willing to provide written informed consent on the IRB approved Informed Consent Form

Exclusion Criteria:

* None