cyrilzakka/clinical-trials huggingface dataset:
Renal Fractional Flow Reserve in Renal Artery Stenting

The purpose of the study is to determine potential utility of renal fractional flow reserve in prognosis predicting after renal stent implantation.


Eligibility Criteria:
Inclusion Criteria:

* At least moderate (60% or more) renal artery stenosis with atheromatic appearance in angiography
* Hypertension defined according to WHO criteria
* Age 18-75 years
* Signed informed consent obtained

Exclusion Criteria:

* Bilateral renal artery stenosis or significant renal artery stenosis in solitary kidney
* Contraindications to percutaneous renal angioplasty with stenting
* Atrophy of the kidney supplied with stenosed artery
* Other well known secondary reason for hypertension
* Chronic heart failure NYHA II-IV
* Significant valvular heart disease qualified for surgery
* Persistent atrial fibrillation
* Renal failure with GFR below 30ml/min
Synovium Brushing to Augmented Microfracture for Improved Cartilage Repair

This is a proof-of-concept study to determine the safety and efficacy of a novel device to increase the reparative capacity of the knee. The discovery of a resident population of mesenchymal stem cells (MSCs) within synovial fluid (SF) was the first description of this reparative cell population having direct access to superficial cartilage and joint structures. The ready access of SF MSC to cartilage and other joint tissues offers a novel strategy for joint repair. Current arthroscopic procedures result in the removal of all SF MSCs due to continuous irrigation throughout the procedure. The current study would benefit the patient by greatly increasing the reparative capacity of the joint by bolstering MSC numbers and retaining those MSCs within the joint after surgery. By accessing MSCs from the synovium it is anticipated that these cells would be entrapped/migrate into the marrow clot formed by microfracture of the sub-chondral bone. These MSCs would supplement those from the marrow and may result in faster, better quality repair.

The synovium is a rich source of potent chondrogenic mesenchymal stromal cells (MSCs). Gaining access to this valuable source of regenerative cells could improve the outcome of joint restorative procedures. To avoid costly two-stage procedures and ex vivo manipulation, exploiting these autologous cells in a minimally invasive way with minimal manipulation could provide a novel cost-effective approach.

This study will evaluate the safety, feasibility and efficacy of a novel medical device (a synovial brush) and procedure (synovial brushing) to increase the number of autologous minimally manipulated MSCs in the knee. Twenty patients undergoing microfracture for isolated chondral defects will be randomly assigned to either a control group (microfracture only, 10 patients) or the intervention group (microfracture plus synovial brushing, 10 patients). The device is intended to increase the number of MSCs within the joint as a final stage during surgery, aiding repair by bolstering those MSCs recruited from the bone marrow.

Eligibility Criteria:
Inclusion Criteria:

* Isolated cartilage defects (\<2cm2)
* Patients undergoing microfracture for repair of cartilage defects

Exclusion Criteria:

* Septic arthritis
* Infectious disease
* Revision joint surgery
* Meniscal damage requiring repair
* Ligament damage requiring repair
* Cartilage defect greater than 2cm2
* Contra-indications for MRI:

  * Pacemakers, Implantable Cardioverter defibrillators, implantable cardiac loop recorders
  * Surgical clips within the head
  * Certain inner ear implants
  * Neuro-electrical stimulators
  * Metal fragments within the eye or head
Effects of Pilates Method and Aerobic Training in Hypertensive Subjects

This study evaluates the effects of Pilates method and aerobic training in hypertensive subjects. Half of participants will be trained with Pilates, while the other half will be trained with aerobic exercise during 8 weeks.


Eligibility Criteria:
Inclusion Criteria:

* subjects with high blood pressure controled by medication;
* sedentary.

Exclusion Criteria:

* IMC≥30 kg/m²
* using beta blockers
* smokers or that interrupted the routine less than 6 months
* musculoskeletal diseases in evolution or with current symptomatic
* rheumatological diseases
* other cardiovascular disease
* renal disease due to hypertension
* endocrine, neurological, oncological, immunological, hematological and psychiatric diseases.
Standard of Care Versus Urine Testing With Selective PHarmacogenomics for Effective Drug and Dosing REgimens

The purpose of this study is to determine whether the addition of selective pharmacogenomic (PGx) testing as determined by Urine Drug Testing (UDT) adds a clinical benefit as evidenced by a reduction in Target Drug-related Adverse Events (TDRAE) over the period following enrollment.


Eligibility Criteria:
Inclusion Criteria:

1. Subject is 12 years of age or older;
2. Subject or legal representative is able and willing to provide informed consent;
3. Subject has had a TDRAE including ineffective therapeutic response within the last 60 days or is a new patient to the treating healthcare provider's practice;
4. Subject is scheduled for or is planned to be scheduled for UDT, ordered as per the treating healthcare provider's local standard of care;
5. Subject is currently receiving or the subject's treating healthcare provider is considering treatment with at least one target drug listed below and metabolized by one or more genes considered in this study: Amitriptyline, Imipramine, Diazepam, Alprazolam, Codeine, Hydrocodone, Oxycodone, Methadone, Meperidine, Fentanyl and Carisoprodol.

Exclusion Criteria:

1. Prior history of PGx testing for genes specific to any of the target drugs in the past;
2. PGx testing is deemed mandatory in the opinion of the treating healthcare provider;
3. History of liver or renal transplantation;
4. Receiving chronic hemodialysis or peritoneal dialysis;
5. Currently hospitalized or in a long-term care facility;
6. Participation in another clinical trial that would, in the Investigator's opinion, interfere with the conduct of this study;
7. Subject or subject's guardian or advocate is unable to provide an accurate history of the subject's medical history, medications, and symptoms.
A Study on the Effects of Mastiha Oil in Adults With Hypertriglyceridemia

Mastiha Oil is a 100% natural product of the Mediterranean, extracted from the resin of Mastiha. Its composition is high in bioactive ingredients (such as terpenic acids and polyphenols) which have proven anti-inflammatory, antioxidant, cardioprotective, chemoprotective and antimicrobial properties. The aim of this study is to determine the effect of Mastiha oil in adults with Hypetriglyceridemia. 100 participants will be allocated to two groups, (50 in intervention group and 50 in control group). Mastiha oil will be provided in the form of soft gel capsules to the intervention group, whereas the control group will not consume the capsules. Both groups will receive standard nutritional counselling. The intervention will last 3 months.

The effects of the intervention will be evaluated via clinical and laboratory markers.


Eligibility Criteria:
Inclusion Criteria:

* 30 years \< Age \< 75 years Hypetriglyceridemia A stable weight for ≥ 3 months pre-intervention An unchanged treatment regimen for ≥ 6 months pre-intervention

Exclusion Criteria:

Hepatotoxic Medication Untreated Diabetes Mellitus Dysthyroidism, hypopituitarism, Cushing syndrome / disease Pregnancy, lactation Psychiatric or mental disorder Any use of antioxidant-phytochemical rich supplement, vitamin D supplement, anti-, pre- or pro-biotics within 3 months pre-intervention
Studies of HIV-1 Infection in Newly Infected Individuals in Southern Africa

The main goal of this study is to find out how the immune system responds to a specific type of HIV infection, known as C HIV-1, in order to develop a vaccine against this type of infection. The study involves Southern African populations.

The HIV-1 virus changes rapidly and many different subtypes have been found. In South Africa, limited data have suggested Subtype C HIV-1 is the most common. This study strives to verify the most common subtype and also look at genetic differences and immune responses among newly infected individuals. Results will aid in the development of vaccines specific for certain geographical areas.

HIV-1 evolves rapidly and multiple genetic subtypes have been isolated from a number of geographic locations. There are limited data on the distribution of subtypes in the Southern African HIVNET sites. Data suggest subtype C HIV-1 predominates and this study is designed to substantiate and extend these observations to understand the biological relationship between HIV-1 subtypes, genetic variability, and immune responses. Earlier studies were conducted using individuals who had been seropositive for 3 to 9 years with advanced disease status; this study will test reactivity during the early stage of infection. This will assist in the rational selection of prototypic isolates for inclusion in either a single universal vaccine or vaccines tailored for specific subtypes/geographical regions.

Volunteers are recruited from Malawi, South Africa, Zambia, and Zimbabwe. The earliest possible cases of seroconversion are included. At enrollment, participants are counseled appropriately for their HIV status and demographic information is obtained. Participants are followed quarterly up to 12 months. Epidemiological, clinical, and laboratory data are collected during physical exams and blood draws at each visit. Blood samples are used to assess CD4 counts, plasma viral load, genetic parameters, and individual immune responses. Participants who are seronegative or whose status is unknown are tested for HIV at each visit, with post-test counseling when participants return to the clinic for test results.

In addition to enrolling the HIV-infected and uninfected volunteers, each site contributes a 5-ml blood sample from 50 seronegative individuals for DNA extraction and HLA genotyping.

Eligibility Criteria:
Inclusion Criteria

Participants may be eligible for this study if they:

* Are first HIV-negative and later test HIV-positive; or are HIV-positive and have evidence of being HIV-negative within the 8 months prior to first testing HIV-positive; or are HIV-positive with one test and HIV-negative with another test.

Exclusion Criteria

Participants will not be eligible for this study if they:

* Have a mental disorder that interferes with agreeing to do the study or with participating in the study.
* Are receiving anti-HIV treatment for more than 4 weeks.
* Have tuberculosis.
Pregnenolone for the Treatment of Alcohol Use Disorder

This Phase 2 randomized cotrolled trial (RCT) will assess the safety and efficacy of pregnenolone (PREG; 300 mg/day, b.i.d dosing) vs. placebo (PBO) over a 12 week treatment period, and at 1-month post-treatment follow-up in individuals with Alcohol Use Disorder (AUD).

In this Phase 2 single-site randomized controlled trial (RCT), men and women with Alcohol Use Disorder (AUD) will be enrolled in a 12 week trial with a 1-month follow-up assessment. Participants will be randomly assigned to 300mg pregnenolone (PREG) treatment b.i.d., or Placebo (PBO). All participants will be assessed 2x weekly and also receive behavior counseling to support recovery. The study aims to examine a) the safety and tolerability; b) efficacy on alcohol use outcomes; and c) effects on alcohol craving, anxiety, depression and physical well-being of 300mg PREG vs. PBO in men and women with AUD over the 12-week treatment period and at the 1-month follow up post-treatment period.

Eligibility Criteria:
Inclusion Criteria:

* Male and females, aged 18-70 years;
* Regular weekly use of alcohol at least 3X weekly or more at treatment entry;
* Must meet current DSM-5 criteria for moderate to severe Alcohol Use Disorders (AUDs) using SCID-I for DSM-5;
* No health conditions that would impact trial participation as verified by screening and physical examination and absence of any of the exclusion criterions outlined below;
* Able to read English and complete study evaluations;
* Able to provide informed written and verbal consent.

Exclusion Criteria:

* Meet current criteria for moderate to severe substance use disorders from use of any other psychoactive substance, excluding nicotine and cannabis use disorder;
* Current use of opioids;
* Regular use of anticonvulsants, sedatives or hypnotics, oral prescription analgesics (other than non-steroidal anti-inflammatory drugs), topiramate, baclofen;
* Regular use of steroidal supplements and steroid medications interacting with study medications based on clinical judgement of study physician (excluding hormonal contraceptives in women);
* Psychotic or otherwise severely psychiatrically disabled (i.e., suicidal, homicidal, current mania);
* Significant underlying medical conditions such as cerebral, renal, thyroid or cardiac pathology which in the opinion of study physician would preclude patient from fully cooperating or be of potential harm during the course of the study, but stable, prescribed anti-hypertensives. cardiovascular and diabetes medications will be allowed after review by study physician;
* Any psychotic disorder or current Axis I psychiatric disorders requiring specific acute attention, including need for psychiatric medications, but stable, prescribed antidepressants and anti-anxiety medication to treat co-occurring psychiatric disorders will be allowed;
* Women who are pregnant, nursing or refuse to use a reliable form of birth control (as assessed by urine pregnancy tests during initial medical evaluation, and assessed every two weeks during the course of the study).
COMFORT Study: A Crossover Study of NeoRecormon (Epoetin Beta) and Darbepoetin Alfa in Patients With Renal Anemia.

This study will assess the comfort of subcutaneous injections of NeoRecormon and darbepoetin alfa (Aranesp) in patients with renal anemia. Eligible patients will be randomized to receive comparable subcutaneous injections of either darbepoetin alfa (30 micrograms) or NeoRecormon (6000IU). They will then be crossed over to the alternative treatment arm for further treatment. After each injection pain will be assessed using the visual analogue scale (VAS) and 6-point verbal rating scale (VRS), and patient preference will be assessed. The anticipated time on study treatment is \<3 months, and the target sample size is \<100 individuals.


Eligibility Criteria:
Inclusion Criteria:

* adult patients, \>18 years of age;
* patients with renal anemia or post-transplant anemia.

Exclusion Criteria:

* poorly controlled hypertension;
* known hypersensitivity to NeoRecormon or darbepoetin alfa.
Home-Based Telerehabilitation for People With Alzheimer Disease

The aim of this study is to investigate the effect of a physical exercise program with cognitive tasks to be applied with telerehabilitation in Alzheimer's disease, on cognitive and physical function, ability to perform daily living activities, depression and anxiety. Secondary aim is to examine the effect of the exercise application on the care burden and well-being of caregivers.

Exercise application in the study will take 6 weeks. Evaluations will be made twice, at the beginning and end of the exercise application.

Functional mobility was measured with the 5-Times Sit-and-Stand Test (5XSTS) and Timed Up and Go Test (TUG); static balance with One-Leg Stand Test; functional independence level with Functional Independence Scale (FIM); daily living activities will be evaluated with the Katz Activities of Daily Living Scale.

The general cognitive level of the cases was determined by Mini-Mental State Examination; Depressive symptoms will be measured with the Geriatric Depression Scale-Short Form, and anxiety levels will be measured with the Beck Anxiety Scale.

The care burden of caregivers will be assessed with the Zarit Care Burden Scale, and caregiver's well-being will be assessed with the Warwick-Edinburgh Mental Well-being Scale.

Primary outcome measures are Mini Mental Test, Timed Up\&Go Test, and the 5-Times Sit-and-Stand Test .

Eligibility Criteria:
Inclusion Criteria:

1. Over 65 years old,
2. Diagnosed with Alzheimer's disease according to the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease (NINCDS-ADRDA) criteria,
3. Scoring between 0-2 points according to the Clinical Dementia Rating Scale (with mild-moderate dementia-related symptoms),
4. Have used any dementia medication such as cholinesterase inhibitors and memantine for at least the last month,
5. Mini Mental Test score between 13-24 points,
6. The caregiver living with is sufficient in the use of technology,
7. Cases who could understand the instructions given in Turkish were included in the study.

Exclusion Criteria:

1. Dementia with Lewy bodies, frontotemporal dementia and one of the other types of dementia,
2. Having a pulmonary, neurological, musculoskeletal or rheumatological disease that may prevent exercise,
3. Unstable medical condition (uncontrolled diabetes or hypertension, deep vein thrombosis, etc.),
4. Modified Charlson Comorbidity Index score greater than 6,
5. Receiving any rehabilitation service from an institution or person,
6. Having regular exercise habits,
7. Subjects with visual or auditory deficits or behavioral problems that would make communication difficult were not included in the study.
STHLM3 AS NorDCaP - a Followup Study of Men on Active Surveillance of Prostate Cancer

The aim of the STHLM3 AS NorDCaP study is to evaluate the Stockholm3 test in an active surveillance cohort to predict upgrading on rebiopsy. The study follows a paired design, evaluating our proposed protocol for follow up men on active surveillance with Stockholm3 versus the standard protocol according to national guidelines with PSA.

STHLM3 AS NorDCaP is a cross-sectional multi-center study, evaluating the predictive value of Stockholm3 test in a prostate cancer cohort on AS for upgrading on rebiopsy. Men from the study sites, diagnosed with prostate cancer and currently on AS and planned for rebiopsies will be invited to the study. Eligible individuals have to be alive without any severe comorbidity and without a history of initiating treatment; surgery, radiation, hormone therapy or chemotherapy. To avoid the need for additional investigations, sampling will be synchronized with timing for planned follow-up within the AS program for each individual.

At baseline blood will be drawn for Stockholm3 analyses. The patient will be asked to fill out an informed consent. For each man the following data will be collected: Stockholm3 Risk Score, Stockholm3 Prostate Volume cut-off, total PSA, DRE status, MRI results (PI-RADS, optional, only if MRI is conducted within 3 months before biopsy), prostate volume, biopsy results (ISUP, cancer length, number of positive cores, total number of cores and stage).

Main outcome measurement will be number of upgrading, i.e. number of detected ISUP ≥ 2 cancers.

Eligibility Criteria:
Inclusion Criteria:

* Men diagnosed with low-risk PC and currently on AS and planned for follow-up with systematic and/or fusion biopsies as following standard of care.

Exclusion Criteria:

* History of treatment for prostate cancer; surgery, radiation, chemotherapy or hormonal treatment.
* Severe illnesses such as metastatic cancers, severe cardio-vascular disease or dementia
Lumbar Proprioception in Lower Back Pain Patients Versus Healthy Subjects : a Comparative Study on the Effects of Low- and High-frequency Muscle Vibrations

The primary objective of this study is to compare the lumbar proprioception of patients with chronic back pain to that of healthy volunteers during low- and high-frequency muscle vibration.

The order of measures (low frequency of vibration, high frequency vibration and no vibration) is randomized in a cross-over design.

Patients and volunteers are matched by age and body mass index.

The secondary objectives of this study are:

A-Measure the effect of low- and high-frequency vibrations on lumbar repositioning in patients with chronic lower back pain.

B-Measure the effect of low- and high-frequency vibrations on lumbar repositioning in healthy volunteers.

Our working hypothesis is that low frequency vibrations induce an illusion of shortening, and high frequency vibrations induce an illusion of elongation. The variability of the error should not increase.

Eligibility Criteria:
Inclusion Criteria for patients:

* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* The patient has had chronic low back pain (which did NOT originate in a postoperative setting) for at least 6 months

Inclusion Criteria for healthy volunteers:

* The subject must have given his/her informed and signed consent
* The subject must be insured or beneficiary of a health insurance plan

Exclusion Criteria for patients:

* The patient is under judicial protection, or any kind of guardianship
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* The patient is pregnant, parturient, or breastfeeding
* The patient has a history of spinal surgery
* The patient has a history of preexisting postural disorder preceding low back pain
* The patient has been treated in the last month (e.g. back pain injections)
* The patient has a balance disorder, blindness, inability to perform the experimental protocol

Exclusion Criteria for healthy volunteers:

* The subject is under judicial protection, or any kind of guardianship
* The subject refuses to sign the consent
* It is impossible to correctly inform the subject
* The subject is pregnant, parturient, or breastfeeding
* The subject has a history of spinal surgery
* The subject has a history of preexisting postural disorder preceding low back pain
* The subject has been treated in the last month (e.g. back pain injections)
* The subject has a balance disorder, blindness, inability to perform the experimental protocol
* The subject has a history of acute low back pain \> 15 days or which has resulted in leave from work for more than 7 days in the 5 years preceding the study