cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Biofeedback-Assisted Pelvic Muscle Floor Training and Electrical Stimulation on Women With Stress Urinary Incontinence

The pathophysiological mechanism of stress urinary incontinence divides stress urinary incontinence into urethral hypermobility and intrinsic sphincter deficiency. Pelvic floor muscle exercise as first line therapy has been found to be extremely helpful in patients with mild to moderate forms of incontinence. Biofeedback uses an instrument to record the biological signals ( electrical activity) during a voluntary pelvic floor muscle contraction and present this information back to the woman in auditory or visual form. Electrical stimulation can aid in detecting pelvic floor muscles, and also promote the contraction of the pelvic floor muscles and strengthen the muscles. This study assumes that urinary incontinence women with different pathophysiological classifications receiving a pelvic floor muscle training with surface electromyographic biofeedback and electrical stimulation show differences in the strength of pelvic muscle and degree of symptoms improvement.

Participant will be assigned randomly to biofeedback-assisted pelvic floor muscle training (PFMT) group and biofeedback-assisted pelvic floor muscle training (PFMT) combined with electrical stimulation group. Each of the participant will receive the therapy for two months.The investigators expected that combination therapy will improve the compliance and severity of symptoms in women with stress urinary incontinence.

Eligibility Criteria:
Inclusion Criteria:

1. overactivity bladder for more than 3 months
2. more then 20 year old,less then 85 year old and acceptable to receive vaginal examination
3. need to match schedule with the investigator's clinic for 45 times,followed by individual therapy, each takes about 30 to 60 minutes, a total of 8 weeks of pelvic floor muscle exercises

Exclusion Criteria:

1. Suffering from systemic neuromuscular diseases, such as stroke, spinal cord injury, peripheral neuropathy, etc.
2. Kidney disease
3. Liver disease
4. Patients with cardiac rhythm devices.
5. Insufficient cognitive function, unable to cooperate with pelvic floor muscle exercises.
6. Women during pregnancy.
7. Maternity within six weeks after delivery
Pharmacodynamic Evaluation of Intramuscular Nalmefene Autoinjector 1.5 mg Compared to Intranasal Narcan 4 mg

The purpose of this study is to determine the pharmacodynamics (change in minute ventilation) of nalmefene when given as an autoinjector intramuscularly (IM; into the thigh) compared to naloxone when given intranasally (IN; into the nose) to healthy subjects with prior opioid exposure under steady state fentanyl concentrations (opioid agonism).


Eligibility Criteria:
Key Inclusion Criteria include:

1. Healthy and free of significant abnormal findings as determined by medical history, physical examination, clinical laboratory values, vital signs, and ECG.
2. Body weight ranging from 50 to 100 kg (110-220 lbs) and body mass index (BMI) within the range \[18-30\] kg/m2 (inclusive).
3. Willing to be compliant with the protocol, capable of subjective evaluation, if applicable, able to read and understand questionnaires, if applicable.

Key Exclusion Criteria include:

1. Females who are pregnant or lactating.
2. Any significant illness during the 30 days preceding the initial dose in this study.
3. History or any current conditions that might interfere with drug absorption, distribution, metabolism or excretion.
4. Refusal to abstain from caffeine or xanthine containing beverages entirely during confinement.
5. Refusal to abstain from consumption of alcoholic beverages 48 hours prior to initial study drug administration and through the end-of-study visit.
6. Difficulty with venous access or unsuitable for or unwilling to undergo catheter insertion.

Other inclusion/exclusion criteria may apply.
Survivors Taking Action With Remote Exercise Training

The proposed pilot study will test the acceptability and feasibility of a sixteen-week, two-arm randomized control physical activity intervention in older cancer survivors. The Survivors Taking Action with Remote exercise Training (JumpSTART) program is intended for cancer survivors (Stage I-III) age 60 or older, living in rural areas. The goal of this intervention is to increase physical activity opportunities for cancer survivors who are geographically isolated by offering exercise classes (EnhanceFitness) online. The real-time instruction of group-based classes helps older adults to exercise by establishing relationships, fostering social support and receiving corrective and supportive feedback from instructors that enhance self-efficacy for exercise.


Eligibility Criteria:
Inclusion Criteria:

* Rural residence by self-report and confirmed with Rural-Urban Commuting Area Codes
* Stage I-III cancer history
* Completion of adjuvant chemotherapy, radiation therapy, or surgery for cancer diagnosis
* Age 60 years or older
* Ability to walk for exercise
* Self-reported minimal or inconsistent participation in strengthening exercise and physical activity (\< 150 minutes/week moderate-to-vigorous physical activity; confirmed with baseline accelerometer measures)
* Clearance for exercise based on a modified, combined Screening Cancer Survivors for Unsupervised Moderate-to-Vigorous Intensity Exercise and the Screening for Physical Activity Readiness Questionnaire (PAR-Q) or physician approval as needed based on the pre-screening/PAR-Q responses

Exclusion Criteria:

* Not available for the study duration
* Unable to communicate by phone
* Unable to attend exercise class at schedule time (M,W,F, time TBD)
* Currently enrolled in another exercise program
* Unable to communicate in English
Tfh Dysfunction in HIV and Aging

The purpose of this research is to evaluate blood samples from HIV infected and non-HIV infected people to understand how aging and HIV infection affect the immune responses (body defenses against infection) to the flu vaccine.


Eligibility Criteria:
Inclusion Criteria:

1. For HIV positive participants:

   * HIV infection, as documented by any licensed ELISA test kit. Participants on ART as a result of prior HIV documented infection will not be required to provide proof of diagnosis of HIV infection.
   * Additional criteria for HIV positive

     1. on ART for at least 1 year. Occasional viral blips up to 1000 copies/ml also acceptable provided the patients are on continuing treatment,
     2. Cluster of differentiation 4 (CD4) count available in the prior 6 months and \>200/mm3
     3. Undetectable viral load (\< 40 copies/mL). Blips of \<1000 copies/mL will be allowed.
2. For HIV negative participants:

   * Documented negative HIV test at the time of study entry, either by any licensed ELISA.
3. For all participants:

   1. Individuals age: ≤35 years and ≥65 years.
   2. No history of other immunodeficiency disorders
   3. Not on steroid or other immunosuppressive/immunomodulators medications.
   4. No active malignancies.
   5. Agreeable to receive both regular standard (STD-TIV) and high dose (HD-TIV) influenza vaccination.
   6. Agreeable to participate in study for a complete course of study full visits including 2 consecutive flu seasons.
   7. Able to provide informed consent.

Exclusion criteria

1. Contraindication to receive influenza vaccination.
2. Non-adherence to ART for HIV positive
3. Unable to provide informed consent.
4. Influenza vaccination already given during the current vaccination season.
5. Known drug abuse including cocaine by history
Goal-directed vs Preemptive Tranexamic Acid Administration in Total Hip Arthroplasty

The present study is a multi-center randomized prospective placebo-controlled non-inferiority trial. The study's primary objective is to compare the amounts of postoperative bleeding using two different TXA administration strategies: empirical TXA administration vs. viscoelastic test-based Goal-directed vs Preemptive Tranexamic Acid Administration in total hip arthroplasty. The secondary objectives include comparing the incidents of hyper-fibrinolysis, thromboembolic complications, and postoperative seizures. Researchers assumed that goal-directed tranexamic acid (TXA) administration using viscoelastic field tests would not be inferior to the empirical TXA administration strategy in reducing postoperative bleeding and hyper-fibrinolysis. It also would be beneficial in lowering TXA-induced thromboembolic complications and seizures.


Eligibility Criteria:
Inclusion Criteria:

Inclusion Criteria patients undergoing following surgery

- total hip arthroplasty

Exclusion Criteria:

* pregnancy
* refusal of allogenic blood transfusion
* taking thrombin
* history of thromboembolic and familial hypercoagulability disease
* recent history of myocardial infarction or ischemic cerebral infarction (within 90 days)
* hypersensitive to TXA
* histroy of convulsion or epilepsy
* taking hemodialysis
* history of Heparin-induced thrombocytopenia
Exercise Training in Grown-up Congenital Heart Disease

Rationale: Regular physical activity and aerobic exercise training are related to decreased cardiovascular mortality in healthy individuals, as well as in individuals with cardiovascular risk factors and cardiac patients. Unfortunately, no such data is available on exercise training in adult patients with congenital heart disease.

Objective: The objective of the ExTra GUCH trial is to assess whether encouragement of a six-month sports participation program in addition to usual care in symptomatic adult patients with congenital heart disease improves exercise capacity and quality of life, and lowers serum N-terminal prohormone brain natriuretic peptide (NT-proBNP) levels.

Study design: International, multi-centre parallel randomized controlled trial.

Study population: Adult patients with congenital heart disease, who are in New York Heart Association (NYHA) class II or III.

Intervention (if applicable): The intervention group receives a six-month individualized exercise training program, the control group receives usual care.

Main study parameters/endpoints: The primary outcome is the change in peakVO2 between patients in the sports participation group, and the control group. Secondary outcome measures are change in NYHA functional class, quality of life, and NT-proBNP levels. The primary safety outcome is the composite of all hospitalizations, and all deaths during, or within three hours after exercise. The secondary safety outcome is the composite of all exercise related injuries for which medical attention is sought.

The investigators intend to submit the trial design of this study for this purpose.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Congenital heart disease of all complexities
* NYHA Class II or III

Exclusion Criteria:

* Inability to give informed consent
* Inability to participate in an exercise training program
* Exercise-induced arrhythmia and/or ischemia
* Cyanosis at rest
* Pregnancy
* Major cardiovascular event and/or procedure within three months previous to inclusion.
* Participation in interventional clinical trial
BAY63-2521:Long-term Extension Study in Patients With Pulmonary Arterial Hypertension

Patients who have completed the 12 weeks treatment of the PATENT-1 trial (study number 12934) will be asked to participate in this long term extension study with BAY63-2521.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have completed 12 weeks of treatment in the double blind trial PATENT 1

Exclusion Criteria:

* Patients who have an ongoing serious adverse event from PATENT 1 that is assessed as related to BAY63-2521 are not allowed to participate in the extension trial.
Anti-inflammatory Effects of Rivaroxaban Versus Dabigatran

The purpose of this study is to evaluate the antiinflammatory effects of rivaroxaban compared with dabigatran in patients with atrial fibrillation.

Previous study showed that administration of rivaroxaban reduced expression of proinflammatory mediators in apolipoprotein E-deficient mice. However, it is unknown whether the anti-inflammatory markers are decreased in patients with atrial fibrillation receiving novel oral anticoagulants.

Eligibility Criteria:
Inclusion Criteria:

* non-valvular atrial fibrillation
* a CHADS2-VASc score of 1 or more

Exclusion Criteria:

* contraindication for rivaroxaban or dabigatran
* stroke or systemic embolism, acute coronary syndromes or peripheral artery disease within 6 months before enrollment
* acute heart failure
* severe chronic renal failure (creatinine clearance \< 30mL/min.)
* receiving dual antiplatelet therapy
* patients with a body weight of 50kg or less
* uncontrolled hypertension
* active malignancy, collagen disease, or infectious disease
* patients undergoing surgery within 6 months before enrollment
* patients who are planned to undergoing catheter ablation for atrial fibrillation
* patients who are not allowed to participate in the trial by judgement of the treating physician
TROPHY - Candesartan Cilexetil Long-term Hypertension Prevention Trial

The purpose of this study is to determine the effectiveness of candesartan cilexetil in preventing hypertension in people with high normal blood pressure. Patients will be randomized to either Candesartan or placebo for an initial 2-year period followed by a second 2-year period of placebo for all patients.


Eligibility Criteria:
Inclusion Criteria:

* Subjects between the ages of 30 and 65 (inclusive) at the time of the informed consent process
* have an average clinic BP in the high normal range of \< 139/85-89 mmHg or 130-139/\< 89 mm Hg (high normal BP range) (mean systolic and/or diastolic pressure based on 3 consecutive measurements) derived from the average of clinic visits 1,2 and 3.

Exclusion Criteria:

* Have proteinuria \>1 + (by dipstick method)
* have a stroke, myocardial infarction (MI), transient ischemic attack (TIA), the presence of any clinically significant evidence of atherosclerosis or hypertensive target organ involvement or any significant medical condition that may compromise participation in this study.
MAGnesIum Alloy Scaffold for Coronary Artery Disease (MAGIC)

The retrospective study will investigate the clinical performance and long-term safety of scaffold implantation in a real world setting including high volume PCI centers in Italy

Coronary stents are the default devices for the treatment of coronary artery disease in percutaneous coronary intervention (PCI) according to existing guidelines. However, thrombosis and restenosis are still the main limitations of current permanent metallic stents. In contrast to Bare Metal Stents (BMSs), Drug Eluting Stents (DESs) have a reduced restenosis rate due to the presence of antiproliferative agents in the coating layer of the stent surface and reduced rate of repeat revascularisation. However, late and very late stent thrombosis remains the limitation of DES in spite of prolonged dual antiplatelet therapy. Bioabsorbable scaffolds have been introduced to overcome limitations of permanent metallic stents.

The aim of this observational retrospective study is to investigate the clinical performance and long-term safety of scaffold in a real world setting.

Institution involved in the present registry are high volume PCI centers. Operators have experience in PCI with bioresorbable scaffolds technology

The study organization is based on:

DATA SAFETY MONITORING BOARD (DSMB) All adverse events will be reported to the DSMB and reviewed on an on-going basis throughout the subject enrolment and follow-up period to ensure the safety of subjects enrolled in this study. In case of clinical events, coronary artery angiographies and percutaneous coronary interventions was reviewed by an independent core-lab.

Eligibility Criteria:
Inclusion Criteria:

* subjects \>18 years
* Able to provide an informed consent
* implantation of at least one scaffold

Exclusion Criteria:

* inability to provide at least one year follow-up
Using Wearable Device to Improve Quality of Palliative Care

This study is going to use wearable devices and smartphones to collect physical data from terminal patients and build a survival predicting model for terminal patients with machine learning. Investigators hypothesize that continuous physical data monitoring could offer a hint to better predictability in end-of-life care.

The study aim to examine the feasibility of utilizing wearable devices and smartphones in palliative patients in Taiwan. In addition, investigators try to identify the relationship between mobile health data and disease progression and establish a predicting model to the emergent medical need and death of patients, via machine learning.

This is a single-arm observational study using wearable devices and smartphones in terminal cancer patients. Investigators planned to enroll 75 patients who receive palliative care. After obtaining consent from the patients or their legally authorized surrogate decision-makers, a baseline assessment will be conducted, with a guide to use wearable devices and phone apps.

Investigators will keep regular follow-up for 52 weeks or until the participants' death. Assessment will be conducted every week, face-to-face or by telephone contact. A routine assessment includes symptoms and functionality in the past week, and vital signs and facial photograph will be recorded if possible. Physical data measured from wearable devices would be recorded continuously. The emergent medical needs of patient, including emergency department visit, unplanned admission and death of participants will be recorded if happen.

The primary outcome is the predictive performance (sensitivity and specificity) of the machine-learning model using wearable device data and symptoms assessment. The secondary outcomes are symptoms, including pain, dyspnea, diarrhea, constipation, nausea, vomiting, insomnia, depression, anxiety and fatigue. Users' opinion and comment to using experience will also be recorded.

Eligibility Criteria:
Inclusion criteria

* Age: 20 years old or older
* Clinical diagnosis: cancer in terminal stage.

Exclusion criteria

- Cannot cooperate with use of wearable devices or smartphones.
Prospective Evaluation of Patient Reported Xerostomia After Whole Brain Radiation

The goal of this prospective observational study is to investigate whether whole brain radiation leads to measurable xerostomia from parotid gland toxicity.

The parotids have not been traditionally considered an organ at risk / avoidance structure in whole brain radiation. However, patients receiving whole brain radiation sometimes complain of dry mouth. Investigators hypothesize that standard whole brain radiation fields cause an acute measurable increase in xerostomia at one month post-radiation, and that the severity of xerostomia is related to the dose received by the parotids. In this study, investigators will use the validated University of Michigan Xerostomia Questionnaire to prospectively collect baseline and post-radiation xerostomia scores up to 6 months after treatment. The radiation dose to the parotids will be evaluated to assess whether there is a dose-toxicity relationship. Investigators anticipate a total accrual of 60 patients with a goal of 48 evaluable patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients to be treated with whole brain radiation in 10-15 fractions to a total dose of 25-37.5 Gy for a diagnosis of brain metastases from any disease site or as prophylaxis in the treatment of potentially subclinical intracranial disease (e.g. from small cell lung cancer).
* Has not had prior radiation that would have exposed the parotids to a significant (estimated \>10 Gy mean parotid dose) level of radiation within the past one year. Patients receiving prior stereotactic radiosurgery for brain metastasis are eligible for inclusion in this trial as this form of radiation is highly conformal and exposes the parotids to minimal (estimated \<1 Gy) radiation.
* Greater than or equal to 18 years of age (no upper age limit).
* Informed consent obtained.

Exclusion Criteria:

* Patients receiving whole brain radiation without the use of a CT-based planning simulation.
* Patients who are on medications known to cause dry mouth, such as anticholinergics.
* Physically unable to communicate by paper or phone to complete the study survey.
* Prisoners.
Study With Lu AF87908 in Healthy Participants and Participants With Alzheimer's Disease

The purpose of this study is to investigate the safety of a single dose of Lu AF87908, how well it is tolerated and what the body does to the drug in healthy participants and participants with Alzheimer's disease.

The study will be divided into three parts: Part A, Part B and Part C.

Part A consists of up to 6 sequential cohorts (Cohorts A1 to A6):

-Cohorts A1 to A6: 8 healthy participants per cohort (aiming for an equal number of men and women): 6 randomized to Lu AF87908 and 2 randomized to placebo.

Part B consists of up to 3 sequential cohorts (Cohorts B1 to B3):

-Cohorts B1 to B3: 4 Japanese and 4 Chinese healthy participants per cohort: 6 participants randomized to Lu AF87908 and 2 participants randomized to placebo.

Part C consists of 2 sequential cohorts (Cohorts C1 and C4):

-Cohort C1 will consist of 6 participants with Alzheimer's disease with 3:1 randomization scheme for active: placebo. Cohort C4 will consist of up to 8 participants. Cohort C4 participants will be randomized based on the randomization scheme from Cohort C1.

Eligibility Criteria:
Inclusion criteria

Healthy Participants:

-Men and women ≥18 and ≤65 years of age with a body mass index (BMI) ≥18 and ≤32 kilograms (kg)/square meter (m\^2) and a minimum weight of 50 kg.

Participants with Alzheimer's disease:

* Men and women with a clinical diagnosis of Alzheimer's disease, Stages 3-4 according to the FDA guidelines.
* Mini-Mental State Examination (MMSE) of 15-30.
* Clinical Dementia Scale (CDR) global score up to and including 2.0.
* Confirmed or determined (via amyloid positron emission tomography \[PET\] scan) to be amyloid positive.
* If on FDA approved Alzheimer's disease medication, the treatment has been stable for 4 months prior to Day 1.

  -≥50 years of age.
* BMI ≥18 and ≤40 kg/m\^2 and a minimum weight of 50 kg.

Exclusion criteria:

* Clinically relevant structural brain abnormality as assessed using magnetic resonance imaging (MRI).
* Any past or current treatment with an anti-Abeta or anti-tau active vaccine.
* Any past or current treatment with a monoclonal anti-tau antibody or a tau anti-sense oligomer within the last 6 months.
* Treatment with covid-19, influenza or pneumonia vaccine within the last 30 days prior to dosing of investigational medicinal product (IMP).

Other eligibility criteria may apply.