cyrilzakka/clinical-trials huggingface dataset:
The Application of Somatosensory Interactive Pelvic Floor Muscle Training for Stress Urinary Incontinence in Men Underwent Radical Prostatectomy

The study aims to compare the efficacy of different pelvic floor muscle training (PFMT) modes on improving urinary incontinence (UI) recovery in prostate cancer (PCa) patients after radical prostatectomy (RP). The methods being compared include standard PFMT (S-PFMT) , a somatosensory interactive PFMT (SI-PFMT, an enhanced PFMT) , and a standard PFMT combined with pelvic floor muscle magnetic stimulation (S-PFMT+MS). Eligible participants are randomized into either of the groups to receive different modalities of post-operative PFMT.

Subjects in the S-PFMT group received traditional verbal instructions and paper-based educational materials. For the SI-PFMT group, an interactive experiential education model was adopted. First, an educational video introduced the importance and basic information of postoperative PFMT. Then, synchronized PFMT guidance through a combination of audio and video would be used. Subjects assigned to the S-PFMT+MS group, on the basis of traditional verbal and paper-based education, pelvic floor magnetic stimulation therapy was applied using a pelvic floor magnetic stimulator, operated by the same experienced rehabilitation physician.

Self administered questionnaires and 1-hour pad test would be used to assess the treatment outcomes at 1, 3, and 6 months postoperatively.


Eligibility Criteria:
Inclusion Criteria:

* PCa patients aged 18 to 85 years who had undergone laparoscopic radical prostatectomy (RP)

Exclusion Criteria:

* patients currently participating in other clinical trials and those unable to cooperate with study interventions and follow-up procedures due to specific factors
Photosensitivity of the Skin Under Azathioprin in Renal Transplant Recipients

Photosensitivity of the skin to UVA and UVB will be determined

Photosensitivity of the skin to UVA and UVB in renal transplant recipients with and without azathioprine will be determined. Azathioprine will be discontinued and photosensitivity determined after a wash-out period of three months

* Trial with medicinal product

Eligibility Criteria:
Inclusion criteria:

* Renal transplant recipients under azathioprin

Exclusion criteria:

* Treatment with Prograf (Tacrolimus)
PET/CT Evaluation of Primary and Metastatic Brain Tumors With a Novel Radioiodinated Phospholipid Ether Analogue I-NM404

The purpose of this study is to evaluate diagnostic imaging techniques using 124I-NM404 PET/CT in human brain tumors. This goal will be accomplished by quantifying tumor uptake and determining the optimal PET/CT protocol, comparing PET tumor uptake to MRI, and calculating tumor dosimetry. The long-term goals of this research are to improve the diagnosis and treatment of malignant brain tumors by using radioiodinated NM404


Eligibility Criteria:
Inclusion Criteria:

* Participants will have a contrast enhanced brain MRI which documents evidence of primary or metastatic brain tumor or suspected tumor recurrence after therapy
* Tumor size at least 1.5 cm in greatest axial dimension on MRI. MRI must be obtained within 2 months of study inclusion
* Adult patients 18 or older
* Female patients must not be pregnant or breast feeding and both women of childbearing potential, and men, must use appropriate means of contraception and must be maintained for at least 45 days after injection of 124I-NM404 Participants must not attempt to become pregnant during this time
* Platelet count must be ≥ 160,000/µl, Hematocrit must be ≥ 22%, Leukocyte count must be ≥ 3,000/µL, Creatinine must be ≤ 2.5 mg/dL, ALT must be ≤ 130 U/L, AST must be ≤ 100 U/L, and urine or serum pregnancy test must be negative for pregnancy
* Patient provides informed consent
* Karnofsky score ≥ 60
* For previously treated brain tumors, targeted brain therapy (radiation or drug) must have concluded ≥2 months prior to injection of 124I-NM404

Exclusion Criteria:

* Life expectancy of \< 3 months
* Allergy to potassium iodide (SSKI or Thyroshield)
* Unwilling or unable to complete 3 separate PET/CT imaging sessions of 90 minutes each over 3 days
* Pregnancy or breast-feeding during time of study and/or anticipated breast feeding at any time for 45 days after injection of 124I-NM404.
Prognostic Relevance of High-sensitivity Troponin in Patients With Acute Decompensated Heart Failure

The purpose of this study is to investigate the prognostic value of admission high-sensitivity troponin in patients with acute decompensated heart failure.

Patients admitted for acute decompensated heart failure are included in the study. After gaining informed consent, concentrations of high-sensitivity troponin on admission and on discharge are assessed. 6 months after discharged, the incidence of clinical endpoint (mortality of all cause and of cardiovascular cause, hospitalization) is assessed by telephone contact to the patient and/or the physician. The aim of the study is to investigate the prognostic value of high-sensitivity troponin concentration for predicting death and re-hospitalization.

Eligibility Criteria:
Inclusion Criteria:

* Hospital admission for acute cardiac decompensation
* Systolic and / or diastolic heart failure

Exclusion Criteria:

* Myocardial infarction in the last 4 weeks
* Serum creatinine \>2.5 mg/dl
* Pulmonary embolism
The Natural History of Danon Disease

Danon disease (DD) is a rare, X-linked disorder associated with severe cardiomyopathy, and in many cases, skeletal myopathy, and cognitive impairment caused by mutations in the LAMP2 gene. There is still uncertainty regarding the natural history of DD because of its rarity.

This study aims to determine the natural history of DD through the collection and analysis of retrospective and prospective data. To achieve this, the investigators will perform surveys and obtain medical records from DD patients. The same cohort of patients will also be assessed by a multidisciplinary team with expertise in DD (cardiologist, neurologist, ophthalmologist, psychologist, geneticist) at the University of California, San Diego. All patients with DD are eligible, including those who underwent a heart transplant. Additionally, data and records from deceased patients will provide valuable retrospective data for this study.

The study design will include:

1. Collection of information for all patients from:

   * Survey of patient or caregiver (if the patient has deceased)
   * Medical Charts
2. Collection of information from living patients assessed by the multidisciplinary team at the University of California, San Diego including:

   * A complete medical history and physical examination
   * Cardiac Testing (Electrocardiography; Echocardiography; Cardiac magnetic resonance imaging with gadolinium contrast agent-gadolinium contrast is optional-; Cardiopulmonary Test)
   * Pulmonary function testing (PFT)
   * Neuromuscular Assessment
   * Cognitive Tests
   * Vision exam including retinal evaluation
   * Laboratory Tests
   * Questionnaires on Quality of life
   * Needle Skeletal muscle biopsy (only for patients over 18 years old)
   * Abdominal Ultrasound for assessment of the liver structure

Eligibility Criteria:
Inclusion Criteria:

• Living or deceased patients with a diagnosis of Danon disease(including patients who may or may not have undergone heart transplantation) based on a genetic test positive for the LAMP2 mutation

Exclusion Criteria:

• Patients without a genetic test positive for a LAMP2 mutation
SafeBoosC-IIIv - Does Cerebral Oximetry Monitoring Affect Renal Outcomes

Cerebral oximetry monitoring allows clinicians to optimize blood flow to the brain and oxygenation using the SafeBoosC treatment guideline. The guideline's interventions aims to stabilize blood pressure and oxygen levels.

As low blood pressure is a risk factor for the development of kidney injury, normalizing blood pressure may decrease the incidence of kidney injury in new-borns who are on ventilator.


Eligibility Criteria:
Inclusion Criteria:

* \> 28 weeks of gestation Invasively ventilated

Exclusion Criteria:

* major anomalies
A Phase 2 Study to Determine the Safety and Efficacy of Inhaled Dry Powder Mannitol in Cystic Fibrosis

Cystic fibrosis is the most frequent lethal genetic disease of childhood. Causes disruption of glandular function of the pancreas, intestine, liver, lungs (causing chronic lung infection with emphysema), sweat glands and reproductive organs. We know that many CF patients die of lung failure, brought about in part by repeated lung infections caused by thick, sticky mucus that cannot be readily cleared from the lung.

Inhaled mannitol is an osmotic agent that has been investigated in a number of small studies that have examined mucociliary clearance, quality of life and lung function in CF and bronchiectasis. The promising results of these studies warrant futher investigation. The aim of this study is to assess the safety and efficacy of inhaled mannitol when administered twice a day over two weeks in CF.


Eligibility Criteria:
Inclusion Criteria:

1. Confirmed diagnosis of cystic fibrosis (sweat test/genotype)
2. Aged 8 years or older
3. Have FEV1 between 40% and 80% of predicted for height, age and gender OR a decrease in FEV1 of 20% or more than that recorded 6-12 months previously.
4. As determined by the investigator, are capable and willing to

   * Use the study diary as required for this protocol
   * Able to perform all of the techniques necessary to measure lung function
   * Able to administer the dry powder mannitol
5. Are capable of and have given informed consent
6. Clinically stable at study entry

Exclusion Criteria:

1. Investigators, site personnel directly affiliated with this study, and their immediate families.
2. Subjects under the age of 8 years.
3. Subjects with currently active asthma
4. Subjects using hypertonic saline treatment in the last 2 weeks
5. Considered "terminally ill" or listed for transplantation
6. Requiring home oxygen or assisted ventilation
7. Colonisation with Burkholderia cepacia
8. Significant episode of hemoptysis (\>60 mls) in the previous 12 months
9. Myocardial Infarction in the six months prior to enrolment.
10. Cerebral Vascular Accident in the six months prior to enrolment.
11. Ocular surgery in the three months prior to enrolment.
12. Abdominal surgery in the three months prior to enrolment.
13. Subjects who are breast feeding or pregnant.
14. Female subjects of reproductive capability, not using a reliable form of contraception
15. Inability to obtain informed consent from the subject or subject's authorised representative.
16. Subjects who have participated in another investigative drug study parallel to, or within 4 weeks of study entry.
17. Known intolerance to mannitol or beta2 agonists.
18. Uncontrolled hypertension - systolic BP \> 160 and or diastoli
Late Onset Alzheimer's Disease

The goal of this study is to is to focus on the genetic influences on Alzheimer's Disease (AD) risk. The investigators are looking for families and/or individuals (affected or unaffected) of any ethic background (African American, Caucasian, and Hispanics) with a family history of AD and willing to participate.

The purpose of this study is to focus on the genetic influences on Alzheimer's disease (AD) risk. Specifically, the investigators hypothesize that one or more genes, other than the previously identified susceptibility gene apolipoprotein-E (APOE), or the 3 genes associated with early-onset familial AD, presenilin-1 (PS-1), presenilin-2 (PS-2) or B-amyloid precursor protein (APP), increase the risk of AD in families with multiple individuals affected with AD. The investigators propose to test this hypothesis by performing genetic linkage analysis in order to detect the chromosomal location of genes that may increase the risk of Alzheimer's disease. In addition, the investigators will study genes known to increase the risk of Alzheimer's disease and other related disorders such as early onset AD, Pick disease, corticobasal degeneration, progressive supranuclear palsy, and familial frontotemporal dementia with parkinsonism and Lewy Body Dementia.

Eligibility Criteria:
Inclusion Criteria:

* Established diagnosis of definite or probable AD or have a diagnosis of a related neurodegenerative disorder such as Frontotemporal Dementia (FTD) or Lewy Body Dementia (LBD) (will also recruit sporadic FTD and LBD) cases.
* a living sibling with probable or possible AD;
* a third living relative affected with AD (onset age 50 or older) or unaffected (60 or older);
* participants in the proband's generation with an identified companion serving as an informant;
* participants who have capacity to consent or participants lacking capacity to consent with a surrogate/proxy in place to provide consent.

Exclusion Criteria:

* failure to identify an appropriate informant;
* uncertainty of the clinical diagnosis of Alzheimer's disease or other related disorder;
* discovery of additional diagnosis that could account for the clinical manifestations;
* unwillingness to participate;
* failure to identify a living sibling with AD or other related disorder (except in the cases of sporadic FTD and sporadic LBD);
* participants lacking the capacity to consent who do not have a surrogate or proxy or next of kin to provide consent.
Effect of Starter Formula on Infection Prevention

The aim of this trial is to test the efficacy of an infant formula containing synbiotics on the prevention of gastro-intestinal infections.


Eligibility Criteria:
Inclusion Criteria:

* Healthy newborn infant
* Full term infant (≥ 37 weeks gestation; ≤ 42 weeks gestation)
* Age of infant is ≤ 13 days at the time of enrollment
* Birth weight ≥ 2500g and ≤ 4500g
* For the FF groups: The infant's mother has elected not to breastfeed
* For the BF group: The infant's mother has elected to fully breastfeed her baby, from enrollment to at least 3 months of age
* Having obtained his/her legal representative's informed consent

Exclusion Criteria:

* Congenital illness or malformation that may affect normal growth (especially immunodeficiencies)
* Significant pre-natal and/or post-natal diseases
* Perinatal antibiotic or infants on antibiotics at the time of inclusion
* Infants whose mother has had an acute infection during the last month of pregnancy
* Re-hospitalisation for more than 2 days in the first 14 days of life (exceptionally, infants re-hospitalized because of jaundice may be enrolled in the study)
* Receiving infant formula containing probiotics and/or prebiotics at the time of enrollment
* Newborn whose parents / caregivers cannot be expected to comply with treatment
* Newborn currently participating in another interventional clinical trial
Bright Light as a Countermeasure for Circadian Desynchrony

Light is the primary means by which the internal circadian clock remains aligned ("entrained") with the external world. Misalignment of this internal clock can occur during situations such as shift work and jet travel across multiple time zones (jet lag). The purpose of this study is to examine how sequences of brief flashes of light can affect entrainment of the clock.


Eligibility Criteria:
Inclusion Criteria:

* Good health
* Normal hearing

Exclusion Criteria:

* Sleep disorder
* Extreme chronotype
* Regular smoker
* Depression
* Alcohol abuse
* Illegal drug use
Study of the Effect of the Combined Extract of Lemon Verbena and Hibiscus on Health Indicators

Plant polyphenols have demonstrated the ability to ameliorate metabolic alterations induced by overweight and obesity, both in cellular and animal models, where most therapeutic approaches have failed. These have demonstrated the ability to improve appetite sensation, leading to improved body weight control, in addition to reducing fat accumulation and improving plasma glycemic and lipid profiles, as well as inflammatory process and vascular dysfunction. The plant polyphenols on which the extract to be studied will be based will be hibiscus and lemon verbena. A randomized controlled trial will be carried out in overweight or obese subjects from the province of Alicante. An electronic randomization will be carried out based on a two-branch design, therefore, there will be a control group (no intervention) and an experimental group (nutraceutical intake). Participants will have to ingest the nutraceutical for 3 months, as well as attend the agreed visits. Different satiety questionnaires, circulating parameters measured in capillaries (cholesterol, triglycerides and glucose), blood pressure and body composition measured by bone densitometry (DXA) will be collected. All variables will be measured at 4 different time points (baseline, 30 days, 60 days and 90 days). All these will be analyzed as a function of time; at the beginning and end of each intervention (intra-group analysis), as well as comparing the control group with the experimental group (inter-group analysis). A multidisciplinary team formed by physicians, nurses and nutritionists will be involved.


Eligibility Criteria:
Inclusion Criteria:

* Elderly (\< 18 years)
* Overweight (body mass index 25-29.9 kg/m2)

Exclusion Criteria:

* Pregnant or lactating subjects
* Who have participated in another study with similar characteristics in the last 3 months.
* Subjects with pathologies.
* Consumption of drugs and/or supplements
* Subjects with food intolerances/allergies.
* Subjects with muscle or joint injury.
* Subjects with impossibility to follow up the intervention.
* Refusal of informed consent
Cholesterol Lowering Effect of Cardio-Complement, an Ayurveda Formulation

The aim of this feasibility study was to assess the lipid-lowering effects and safety of a Ayurveda formulation containing Terminalia Arjuna, Withania Sominifera, Garcinia Cambogia and piperine (as bioenhancer)

The COVID-19 related lockdowns severely affected the healthcare in India, specially in second wave of COVID-19. This research presents the applicability of Ayurveda formulation to analyze the impact on lipid profile during the lockdown.

Patients with hyperlipidemia who referred to Gyansanjeevani were recruited. All participants were enrolled in the study after a complete physical examination and medical history remotely over the virtual secure platform.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 65 years
* BMI between 18.5 and 40 kg/m2
* Total Cholesterol \>180 mg/dl
* No clinically significant medical history
* Willing to participate to the study by complying with the protocol
* Able to provide written informed consent

Exclusion Criteria:

* Metabolic disorder such as diabetes, uncontrolled thyroidal trouble or other metabolic disorder,
* Severe chronic disease
* History of ischemic cardiovascular event,
* Uncontrolled hypertension
* Under treatment or dietary supplement which could affect study parameter
Safest Choice of Antihypertensive Regimen for Postpartum Hypertension

The purpose of this investigator-initiated randomized control trial is to determine whether oral Nifedipine versus oral Labetalol is superior in controlling high blood pressures in the postpartum period.

High blood pressure (hypertension) is one of the most common medical disorders in pregnancy and affects 10% of all pregnancies in the United States, with possible short-term and long-term health complications including increased risk of stroke, and liver, kidney, and heart disease. Management of severe high blood pressure after delivery involves medications to lower blood pressure, strict discharge instructions and close follow- up after delivery. Both oral Nifedipine and oral Labetalol are considered safe agents for the treatment of postpartum high blood pressure, however few studies exist that directly compare the two. The investigators want to conduct this study because they want to compare the effects of oral Nifedipine or oral Labetalol on postpartum hypertension. In this study, subjects will get either oral Nifedipine or oral Labetalol. Subjects will not get both. No experimental drugs or devices will be used.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Women who develop postpartum hypertension\* after delivery of the placenta or chronic hypertensive postpartum women who require medication for blood pressure control.

  * Postpartum hypertension requiring treatment are defined as systolic blood pressure greater than or equal to 140mmHg or diastolic blood pressure greater than or equal to 90mmHg on at least 2 occasions at least 4 hours apart, or systolic blood pressure greater than or equal to 160mmHg or diastolic blood pressure greater than 110mmHg sustained for more than 15 minutes.

Exclusion Criteria:

* History of moderate persistent asthma, coronary artery disease, heart failure, AV heart block, pulmonary edema
* Contraindication to either Nifedipine or Labetalol
* HR \<60 or \>110
* Native language other than English or Spanish
A Home-based Rehabilitation in ARSACS

48 participants (24 women and 24 men) with autosomal recessive spastic ataxia of Charlevoix-Saguenay (ARSACS) will participate in 2 phases : control phase (12-week usual care) and intervention phase (12-week home-based rehabilitation program). The participants will be evaluated at baseline, week 12 (end of control phase) and week 24 (end of intervention phase) to quantify the effects of an individualized home-based rehabilitation program. Participants will also participate on a focus group at the end of the program to evaluate the acceptability of the program and the perceived changes.

Co-creation phase:

Preceding the intervention, a co-creation phase involving healthcare professionals (3), patient-partners (2), and ARSACS researchers (3) will be conducted to develop the exercises for the rehabilitation program and the evaluation scale to determine the level of difficulty of each exercise assigned to participants.

Intervention phase:

Random sampling stratified by gender and level of indoor mobility (unassisted walking, assisted walking, wheelchair) from the Neuromuscular Clinic's registry of 48 participants (24 women and 24 men) will be conducted.

* Control phase: All participants will be asked to maintain their usual activities for 12 weeks.
* Intervention phase: All participants recruited to the project will complete the home-based rehabilitation program assigned to them for 12 weeks, unsupervised, 20 minutes 3 times a week. Follow-up calls by a physiotherapist will be conducted at weeks 2, 4, 6, 8, 10 and 12.

Eligibility Criteria:
Inclusion Criteria:

* ARSACS diagnosis must be confirmed by genetic analysis;
* Women and men, aged between 18 and 50 years old;
* Be able to perform the sit-to-stand transfer;
* Consent of the neurologist must be given to participate in this study;
* Must reside in the Saguenay-Lac-St-Jean region;
* Subjects must be able to give their consent freely and voluntarily.

Exclusion Criteria:

* Patients who already meet physical activity (PA) recommendations (150 min of moderate to high intensity PA/week) or already participate in a rehabilitation program are excluded;
* Remain in a care facility;
* Do not speak English or French;
* Have another diagnosis causing physical limitations;
* Are pregnant.