cyrilzakka/clinical-trials huggingface dataset:
Prospective Trial of a Validated Algorithm for Warfarin Dosing

The aim of this study is to perform a randomized trial comparing the use of the algorithm, with dosing of warfarin in standard manual dosage clinical practice, in a high quality anticoagulant setting (PSM). This is done for safety concerns and to ensure good performance of the algorithm when used in a clinical setup. The results from the study are expected to increase our knowledge of efficacy by using the algorithm in clinical practice.


Eligibility Criteria:
Inclusion Criteria

* Participants will be those ≥18 years old, must refer to Trombosecenter Aalborg and have to be educated as PSM patient
* Have to be treated for at least 1 month and willing to sign informed consent

Exclusion Criteria

* OAT treatment with phenprocoumon
* Lack of ability to handle the interface on the software used in the study (evaluated by the investigator present at the information meeting)
* Pregnancy
* Those with severe co-morbidities (e.g., creatinine \> 2.5, hepatic insufficiency, active malignancy, advanced physiological age, noncompliance risk, expected survival \<6 months), and physician or patient preference.
Vestibular Rehabilitation for Chronic Central Vestibular Deficits: A Case Study

The purpose of this study is to assess the effectiveness of vestibular rehabilitation for an individual who has chronic central vestibular deficits due to cerebellar dysfunction. Due to the lack of treatment for chronic cerebellar dysfunction with Physical Therapy, the investigators hope to produce a protocol for chronic cerebellar dysfunction utilizing balance training, vestibular rehabilitation, or any other rehabilitation technique that may alleviate or eliminate symptoms.

The purpose of this study is to assess the effectiveness of vestibular rehabilitation for an individual who has chronic central vestibular deficits due to cerebellar dysfunction. Due to the lack of treatment for chronic cerebellar dysfunction with Physical Therapy, the investigators hope to produce a protocol for chronic cerebellar dysfunction utilizing balance training, vestibular rehabilitation, or any other rehabilitation technique that may alleviate or eliminate symptoms.

Investigators will test the subject initially at 4 weeks, 8 weeks and 6 months post start date to assess for symptom improvement.

Eligibility Criteria:
Inclusion Criteria:

* Central vestibular deficits

Exclusion Criteria:

* None
Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel in Subjects With Acne Vulgaris

This was a multi-center, randomized, double-blind, parallel group study with 12 weeks of treatment of acne vulgaris. Efficacy and safety evaluations were performed at Screening (safety only), Baseline and Weeks 1, 2, 4, 8 and 12. All Investigator's Global Assessment evaluators and lesion counters must be trained and approved by Galderma. The evaluator of a participant should remain the same during the study.

The primary objective was to demonstrate the superiority in efficacy and assess safety of adapalene/benzoyl peroxide topical gel (adapalene/benzoyl peroxide gel) versus adapalene topical gel, 0.1% (adapalene monad); benzoyl peroxide topical gel, 2.5% (benzoyl peroxide monad) and topical gel vehicle (gel vehicle) in the treatment of acne vulgaris for up to 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

* A clinical diagnosis of acne vulgaris with facial involvement.
* A minimum of 20 but not more than 50 inflammatory lesions
* A minimum of 30 but not more than 100 noninflammatory lesions
* A score of 3 (Moderate) on the Investigator's Global Assessment Scale
Self-Management and Care of Heart Failure With Group Clinics (SMAC-HF)

The purpose of this study is to help people with heart failure (HF) to manage their HF and to prevent rehospitalizations. Another purpose is to test the usefulness of clinical appointments and educational videotapes in teaching patients how to manage their HF.

It is proposed that the group clinic intervention (HFcareGroup)will reduce rehospitalization, depression, and improve problem solving related to heart failure symptoms.

Aim 1 Hypothesis:

1. The time to the 1st composite endpoint (HF Rehospitalization/death) will be longer for HFcareGroup than standard care group at 12 months.
2. The HFcareGroup will have higher score than standard care on patient outcomes i.e. functional health status, quality of life, satisfaction with health care at 12 months.
3. Health Services Use will be lower in HFcareGroup than standard care group at 12 months.

Aim 2 Hypothesis:

1. The HFcareGroup will have higher score than standard care on patients' HF self-management i.e., self-care behaviors, participation with health care professionals in HF management and problem-solving, HF knowledge and preparedness for home care at 6 and 12 months.
2. A greater proportion of HFcareGroup vs standard care subjects will report clinical or symptoms of HF decompensation (e.g. specific weight gain, shortness of breath, edema, fatigue, tachycardia, and medication side effects) to their health care provider.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* speak English/Spanish
* receiving treatment for congestive heart failure
* receiving IV diuretics
* 2 or more HF symptoms
* be able to participate in follow up visits

Exclusion Criteria:

* primary right-sided heart failure
* HF transient \& related to acute MI
* HF due to correctable cause
* being scheduled for coronary revascularization or any readmission
* receiving infusion for HF therapy within 2 weeks
* having co-morbidities, life expectancy \< 12 months
* severe cognitive impairment
* D/C to nursing facilities or rehab unit
* Currently enrolled in an intervention study or HF management program
* being or planning to become pregnant within 12 months
* severe cognitive impairment
Web-Based Baby Care Education Meleis' Transition Theory Mother's Self-Confidence Newborn Health

Web-Based Baby Care Education Meleis' Transition Theory Mother's Self-Confidence Newborn Health

When the mother is not self-confident; They cannot fulfill their motherhood role, have difficulty in establishing a relationship with their baby, and cannot raise their babies in a healthy way. It is easier for mothers who have the necessary knowledge and skills to care for the baby to adapt to this process. The educational support given in the transition to motherhood will affect the mother's self-confidence and readiness for motherhood, thus affecting the baby's health.

The research will be conducted on the online platform between November 2022 and November 2023. The population of the randomized controlled study was Istanbul Haseki Training and Research Hospital Sultan Gazi Haseki Campus, the pregnant women followed in the pregnant outpatient clinic, the sample was n: 45 pregnant women who attended the online training meeting the sample selection criteria, 45 pregnant women informed on the website, and 45 pregnant women in the control group, a total of 135 mothers. will form the candidate. Pregnant women who are willing to participate in the study will be assigned to the groups by simple randomization method. During the research, the CONSORT 2018 statement will be followed. Research data; Data Collection Form will be obtained by Pregnants' Readiness for Newborn Hygienic Care Scale, Karitane Parental Self-Confidence Scale, LACTH (Breastfeeding Success Assessment) Scale and Infant Follow-up Form.

Eligibility Criteria:
Inclusion Criteria:

* Primiparous pregnant
* Single pregnancy
* Expectant mothers with internet access,
* Expectant mothers who can use digital tools (Smartphone or computer)
* Mothers with healthy babies
* Mothers whose babies were born at term (between 37-42 GH)
* Mothers discharged with their baby
* Those whose baby is with the mother
* Expectant mothers who do not attend pregnancy education classes

Exclusion Criteria:

* The mother has communication problems,
* The mother has a chronic illness,
* Having problems with breastfeeding (breast or newborn),

  * The newborn has IUGR or genetic disease,
  * Failure to attend training sessions.
Evaluation of Prostate-specific Membrane Antigen (PSMA)-Based PET Imaging of Primary Prostate Cancer

The objective of this study is to evaluate a radiolabeled urea-based small molecule inhibitor of prostate-specific membrane antigen (PSMA), \[18F\]DCFBC (DCFBC), as a PET imaging biomarker of prostate cancer detection and aggressiveness at initial diagnosis. PSMA is a well characterized histological marker of prostate cancer tumor aggressiveness but a quantitative non-invasive method for PSMA detection and monitoring is not currently available. Development of such an imaging biomarker would be useful to differentiate indolent from aggressive prostate cancer phenotypes and allow for selection of appropriate risk adaptive therapies. The investigators preliminary first-in-human studies demonstrate high specific DCFBC uptake in metastatic prostate cancer and feasibility for prostate cancer imaging. The investigators propose to study patients initially diagnosed with biopsy-positive prostate cancer to determine if DCFBC uptake and location by PET imaging will be positively correlated with prostate cancer by prostatectomy tissue step-section analysis. DCFBC uptake at sites of suspected metastatic disease will be compared to conventional imaging modalities (CT, bone scan) and biopsy results when available. In addition, DCFBC-PET uptake quantification will be compared with expression levels of PSMA and other prostate cancer relevant markers (PSA, Ki-67, TMPRSS2-ERG) by prostate tissue immunohistochemistry analysis and compared with clinical prognostic markers (PSA, Gleason score, clinical stage, Partin tables derived prediction of pathologic stage).


Eligibility Criteria:
Inclusion Criteria:

1. Newly diagnosed prostate cancer pathologically proven by prostate biopsy
2. Prostate biopsy histology grade ≥ Gleason 3+3=6.
3. Patients considered as candidates for and medically fit to undergo prostatectomy
4. At least 10 days after most recent prostate biopsy
5. No known problems with peripheral IV or central line access
6. Able to tolerate urinary straight catheter placement
7. Patient is judged by the Investigator to have the initiative and means to be compliant with the protocol and be within geographical proximity to make the required study visits.
8. Patients or their legal representatives must have the ability to read, understand and provide written informed consent for the initiation of any study related procedures.

Exclusion Criteria:

1. Prior pelvic external beam radiation therapy or brachytherapy
2. Chemotherapy for prostate cancer
3. Hormone deprivation therapy
4. Investigational therapy for prostate cancer
5. Hemorrhagic cystitis or active prostatitis
6. Unable to lie flat during or tolerate PET/CT
7. Prior history of any other malignancy within the last 2 years, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer
8. No prostatectomy scheduled prior to follow-up visit (12 to 72 hours post imaging)
9. Serum creatinine \> 1.5 mg/dL or creatinine clearance \< 50 mL/min/1.73m2
An Observational Study of a Nutritional Supplement in an Older Malnourished or at Risk of Malnutrition, Hip Fracture Population

This non-interventional, prospective, observational study is designed to observe the use of high calorie, high protein oral nutritional supplement in malnourished or at risk of malnutrition patients after hip fracture surgery, as assessed by a clinician. Subjects will be enrolled and observed for a period of 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Subject has voluntarily signed and dated an informed consent form, approved by an Independent Ethics Committee, prior to any participation in the study.
* Subject is considered malnourished, or is at risk for malnutrition
* Subject conforms to the requirements set forth on the study product label.
* Subject has an estimated, or measured, glomerular filtration rate \>30ml/min/1.73m2 (MDRD equation).
* Subject has been elected for hip fracture surgery and is within three days since surgery.
* The study physician determines the subject is fit to participate.
* Subject is under the care of a health care professional for malnutrition, or is at risk for malnutrition, and has recently been prescribed study oral nutritional supplement by their health care professional.
* After surgery, the subject is free living, resides in a nursing home, or remains in hospital and has an expected length of hospital stay \< 15 days.

Exclusion Criteria:

* Subject has known dementia, brain metastases, eating disorders, history of significant neurological or psychiatric disorder, or any other psychological condition that may interfere with study product consumption AND does not have a caregiver who can assist them with adherence to the study protocol.
* Subject has active cancer and the study physician determines the subject is not suitable for the study.
* Subject has uncontrolled diabetes.
* Subject is known to be allergic or intolerant to any ingredient found in the study product.
* Participation in another study that has not been approved as a concomitant study.
Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Aficamten in Adults With HCM

The purpose of this study is to collect long-term safety and tolerability data for aficamten.


Eligibility Criteria:
Inclusion Criteria:

* Completion of a Cytokinetics trial investigating aficamten
* LVEF ≥ 55% at the Screening Visit

Exclusion Criteria:

* Has received treatment with mavacamten: (a) within 56 days prior to dosing and (b) has not received approval for participation from the Medical Monitor.
* Has participated in another investigational device or drug study or received an investigational device or drug \< 1 month (or 5 half-lives for drugs, whichever is longer) prior to screening. Other investigational procedures while participating in this study are not permitted.
* Since completion of a previous trial of aficamten has:

  * Developed new-onset paroxysmal or permanent atrial fibrillation requiring rhythm restoring treatment (eg, direct-current cardioversion, ablation procedure, or antiarrhythmic therapy) \< 30 days prior to screening. Patient may re-screen for CY 6022 after 30 days if heart rate (HR) \< 100 bpm and/or rhythm is stable \> 30 days
  * Undergone septal reduction therapy (surgical myectomy or transcatheter alcohol ablation)
* Had a confirmed LVEF \< 40% with an associated dose interruption during participation in a prior study with aficamten
* History of implantable ICD placement within 30 days prior to screening.
Effect of EMS and Strengthening Exercises on Pain, Fatigue and Physical Performance in Motocross Athletes

Motocross, a popular sport, involves riding motorized vehicles on rugged tracks with obstacles. It's physically demanding, with high speeds and a risk of accidents. Grip strength is crucial, especially in the arms and forearms, which are prone to injury. Physiotherapy often employs strength exercises, including electromyostimulation. However, there's little research on their effectiveness for motocross athletes. This study aims to compare electromyostimulation combined with strength training versus strength training alone in relieving pain, fatigue, and improving strength in motocross athletes.

Motocross is a popular sport in which participants ride a two-wheeled, motorized vehicle around a 2 km rugged track with natural or man-made obstacles. Participants race at high speeds and it is considered a strenuous sport with a high accident rate. Motocross racers grip the handlebars of their bikes with both hands throughout the race, which lasts between 18 and 26 minutes. Therefore, it is a sports branch where control is concentrated on the arms and upper extremities. It has been reported that the most frequently injured and painful area is the forearm. Therefore, good and strong upper extremity and forearm control is important for the prevention of injuries or subsequent recovery processes.

It is known that strengthening exercise programs are used in physiotherapy practices to improve strength and stabilization parameters. The use of electromyostimulation applications for strengthening in different populations is also becoming widespread.

There are no studies demonstrating the effectiveness of strengthening and electromyostimulation applications on pain, fatigue and strength parameters in motocross athletes.

The aim of this study is to compare the effectiveness of electromyostimulation application applied simultaneously with a strengthening exercise program on pain, fatigue and strength, with strengthening exercises performed with sham application (electric current turned off).

Eligibility Criteria:
Inclusion Criteria:

* Having at least 5 years of professional motocross training experience
* Being between 18 and 30 years old
* Volunteering to participate in the study

Exclusion Criteria:

* To be absent from the 6-week EMS and strengthening program for more than 2 consecutive sessions
* Having suffered any injury that prevents you from training in the last 6 months
* Being receiving a physiotherapy program other than the protocol to be used in the study
Efficacy and Safety of DLBS1425 as Neoadjuvant in Stage II or III Breast Cancer Patients

This is a 2-arm, randomized, double-blind, placebo-controlled study aiming to determine the efficacy and safety of DLBS1425 in combination with anthracyclin-based regimen as a neoadjuvant therapy in subjects with previously untreated stage II or III (operable) breast cancer.

The anthracyclin-based regimen in the study will be either CAF/iv and CEF/iv only. The neoadjuvant anthracyclin-based chemotherapy will be given for 3 cycles. The length of each cycle will be 21-28 days.

The duration of treatment for each subject will be 63 - 84 days (or 3 cycles). The cycle will be initiated at Day-1 (D1 of the 1st cycle). The subsequent cycles will start on Day-22 (D1 of the 2nd cycle) and Day-43 (D1 of the 3rd cycle). DLBS1425 capsules will be administered orally every day (starting from D1 of each cycle) during the study period. All subjects will be under direct supervision of a medical doctor during the study period.

Clinical and laboratory examinations to evaluate investigational drug's efficacy and safety will be performed at baseline and at the end of every cycle over the study course; whilst breast-CT scan will be performed at baseline and at the end of study course.

In addition, at the end of study, at the discretion of Investigator and subjects' own willingness, subjects with good response to treatment (i.e. RECIST and pathological evaluation are regarded as complete or partial response) may continue their breast-cancer therapy with DLBS1425.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed stage II or III (operable) primary breast cancer
* Having radiologically evaluable and measurable lesion(s) of the primary tumor
* Karnofsky performance status 80 %
* Normal cardiac function: LVEF \> 50 %
* Adequate hematological function: Hb ≥ 10.0 g/dL, WBC ≥ 3,000/mm3, ANC ≥ 1,500 /mm3, platelet count ≥ 100,000/mm3
* Adequate liver function: ALT ≤ 2.5 times upper limit of normal, total bilirubin level ≤ 1.5 times upper limit of normal
* Adequate renal function: serum creatinine ≤ 1.5 times upper limit of normal
* Able to take oral medication

Exclusion Criteria:

* Pregnancy or breast feeding subjects
* History of previous breast cancer (recurrent breast cancer)
* History of other cancer within the past 5 years
* Prior systemic treatment for the current breast cancer
* Prior preoperative topical treatments for the current breast cancer
* Uncontrolled or serious CVD
* Known or suspected hypersensitivity to any of the chemotherapeutic agents used in the study
* Any other serious disease state or medical condition which judged by investigator could interfere with trial participation or trial evaluation
* Concurrent herbal (alternative) medicines or food supplements suspected to have effect on breast cancer disease within 14 days prior to screening
* Severe psychological or neurological disorder or dementia that would preclude understanding of the informed consent
* Participation in any other clinical studies within 30 days prior to screening
Niacin (+) Laropiprant (TREDAPTIVE) Re-examination Study (MK-0524A-119)

This survey is being conducted to assess the safety and efficacy of niacin (+) laropiprant (TREDAPTIVE) in usual practice in Korea according to the new product re-examination regulations of the Korean Food and Drug Administration.


Eligibility Criteria:
Inclusion Criteria:

* Participants who are treated with TREDAPTIVE tablet within current local label for the first time
* Participants with primary hypercholesterolemia or mixed dyslipidemia
* Participants who are treated with TREDAPTIVE for more than or equal to 24 weeks will be included in long-term surveillance
* Special participants with known hepatic disorder or renal disorder, participants 65 years old or older, participants younger than 19 years old, and pregnant woman will be evaluated if collected.

Exclusion Criteria:

* Participant who is treated with TREDAPTIVE tablet before contract and out of enrollment period
* Participant who has a contraindication to TREDAPTIVE tablet according to the current local label
Hydrogen-rich Water for Non-alchoholic Fatty Liver Disease

This study evaluates how 4-week supplementation with hydrogen-rich water affects liver fat accumulation, blood lipid profiles and body composition in patients with non-alcoholic fatty liver disease

Non-alcoholic fatty liver disease (NAFLD) is a metabolic disorder characterized by liver fat deposition due to causes other than excessive alcohol consumption. NAFLD can cause many liver dysfunction-related symptoms and signs, with the disease may progress to non-alcoholic steatohepatitis, a condition marked by liver inflammation, fibrosis and irreversible damage. NAFLD is usually accompanied by insulin resistance and obesity, with up to 30% of population in industrialized countries have NAFLD. While NAFLD is rapidly becoming the most common liver disease worldwide, its treatment remains elusive, and directed toward correction of the risk factors. Since metabolic impairment plays a major role in NAFLD pathogenesis, any agent that advance lipid and glucose metabolism could be appropriate to tackle this complex condition. Molecular hydrogen (H2) has recently emerged as a novel pro-metabolic agent that might positively affect liver health. Supplemental hydrogen improves blood lipid profiles and insulin resistance in overweight women, patients with type 2 diabetes, and in subjects with potential metabolic syndrome. In addition, drinking hydrogen-rich water reduces hepatic oxidative stress and alleviated fatty liver damage in rodents. However, no human studies so far evaluated its effectiveness to alter liver steatosis in patients with NAFLD. In this pilot trial, we analyze the effects of 4-week hydrogen-rich water intake on liver fat deposition, body composition and lab chemistry profiles in overweight patients suffering from NAFLD.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Body mass index \> 25 kg/m2
* Free of major diseases besides NAFLD
* Must be able to give written informed consent

Exclusion Criteria:

* Use of any dietary supplements within 4 weeks before study commences
* Abnormal values for lab clinical chemistry (\> 2 SD)