cyrilzakka/clinical-trials huggingface dataset:
Impact of Exercise Training on Single Ventricle Function in Paediatric Fontan Patients

The goal of this observational study is to learn about how a prescribed Exercise Training Program would affect children living with a Fontan circulation.

From birth, the children who are born with single functioning ventricle will undergo 3-staged Fontan surgery to achieve a unique Fontan circulation, supported by one functioning ventricle. With advancement in surgical technique and medical care, there are increasing number of children living with Fontan circulating surviving into adulthood.

A significant number of these individuals develop complications in their adulthood due to problems related to this unique circulation, including reduced exercise tolerance, heart failure, abnormal heart rhythm or premature death. Many of these children have acquired sedentary lifestyle, and may have lower self-perceived health related quality of life.

Exercise training is a well-established therapy used in adult population with heart failure. It has been shown to be safe in children with congenital heart disease and with Fontan circulation, it improves their aerobic exercise capacity which is associated with better outcomes.

The main question\[s\] it aims to answer are the impact of a Exercise Training program on:

1. Single ventricle function
2. Exercise capacity
3. Self-perceived quality of life
4. Skeletal muscle mass

Participants will be given a 20-weeks exercise program, 3 sessions of 30 minutes workout weekly, to carry out at home. The following tests will be performed prior to starting and upon completion of the exercise program:

* Echocardiogram
* Cardiopulmonary exercise test
* Body composition scan using a bio-impedance analyser
* Quality of life questionnaires


Eligibility Criteria:
Inclusion Criteria:

* Patients with Fontan circulation, age range 8 to 18 years
* Ability to perform a cardiopulmonary exercise stress test (CPET)
* Free from acute or chronic respiratory illness and/or conditions that might affect exercise performance
* Who have had a Fontan operation at least six months prior.

Exclusion Criteria:

* Existing neuro-disability i.e. with paresis post cerebrovascular accident
* Neurodevelopmental issue with inability to comply with commands.
* Documented life-threatening arrhythmia without implantable cardioverter defibrillator
* Moderate or severe atrio-ventricular valve regurgitation
* Moderate or severe ventricular dysfunction by echocardiography exams
* Acute inflammatory cardiac disease
* documented coronary artery stenosis and/or myocardial ischaemia
* Heart failure requiring hospitalisation in the past year
* Evidence of systemic venous pathway obstruction by echocardiography or catheterisation
* Resting oxygen saturation \< 90%
* Systemic ventricular outflow tract stenosis with peak resting systolic gradient \> 50mmHg
The Risk Factors of Symptomatic Gallbladder Stone: Age-Sex Matched Case-control Study Performed in Single Institute

The main purpose of this study is to investigate the region-specific cause of gallbladder stone incidence in Jeju Self-Governing Province, Korea.

Investigators performed the epidemiologic study to uncover the reason of relatively higher incidence of Gallbladder cancer in small isolated island, Jeju island, one of small province among 11 self governing area in South Korea. Tow studies, including descriptive epidemiology and analytic epidemiology using case-control study, some risk factors were obtained regarding Gallbladder cancer development in this area. Old age, female, and gallstone were potential risk factors and alcohol consumption was preventive factors. So authors decided to evaluate the relationship between alcohol and gallbladder stone in order to how much portion of causal relationship they have with gallbladder cancer. So this study was designed to investigate the relationship between gallbladder stone and alcohol consumption then performed clinical based case-control study with age-sex matching to each subjects.

Eligibility Criteria:
Case group

Inclusion Criteria:

* Clinical diagnosis of gallstone disease after cholecystectomy.

Exclusion Criteria:

* Ambiguous diagnosis cases for gallbladder stone.
* Incomplete medical record.

Control group

Inclusion Criteria

* Healthy examinees in Health Promotion Center in same Institute
* Eligible cases of abdominal ultrasound(US) or computed tomography(CT)

Exclusion Criteria

* The case who was diagnosed as asymptomatic gallstone on abdominal US
Comparison of Hemodynamic Effects of Two Colloid Therapies in Post-operative Patients Undergoing Pancreaticoduodenectomy

From postoperative patients having undergone pancreaticoduodenectomy;

1. To compare the hemodynamic parameters from the patient administrated 5% HA and 6% Voluven
2. To assess the efficacy of the treatment as regards the clinical outcomes and laboratory parameters of the patient
3. To compare the safety of the 2 intravenous colloids in the patient population


Eligibility Criteria:
Inclusion Criteria:

* Subjects should be meet inclusion criteria to participated into the study

  1. Age-from 18-75 years adult
  2. In the immediate post-operative period of pancreaticoduodenectomy
  3. Written informed consent and admitted ICU immediate post-operative patient

Exclusion Criteria:

* Any patient meeting one or more of the following exclusion criteria may not be entered into the study.

  1. Refusal to participate in the study
  2. Evidence of pre-operative oliguria (Serum creatinine\>1.5mmol/dL)
  3. Known Severe congestive heart failure (NYHAIII,IV)
  4. Known severe respiratory diseases (PaO2/FiO2 \<200)
  5. Known coagulopathy (Platelet\<100k/mm3, aPTT\>70s, PT(INR)\>2.5)
  6. Known allergy to hydroxyethyl starch
  7. Known pregnancy or lactation
  8. Has participated in any other clinical trial within 3months
  9. Any contraindication to Voluven® or albumin according to their package inserts.
Phase II Study Evaluating the Efficacy of Tacrolimus Extended Release Tablets to Twice Daily Tacrolimus Dosing Regimen

This phase II, single-center, open-label study will evaluate the comparable efficacy of tacrolimus extended release tablets (Envarsus®) to the standard of care (SOC) twice daily tacrolimus (Prograf®) dosing regimen post-cardiac transplantation.

This is a prospective, open-label, 2-arm, clinical trial to evaluate the efficacy of extended release tacrolimus (Envarsus) once-daily in comparison to Prograf capsules twice-daily after heart transplantation receiving the standard of care twice daily dosing with tacrolimus (Prograf).

Secondary objectives are to compare the compliance, safety and efficacy of once a day dosing (Envarsus) versus twice a day dosing (Prograf) and to evaluate the short term safety and tolerability of Envarsus.

Approximately 25 adult male or female recipients of a heart transplant will be prospectively enrolled to once-daily therapy with Envarsus tablets. Time of initiation will follow current standard of care. In addition, 25 age/gender-matched subjects who are receiving twice daily dosing with Prograf will be identified from the transplant center database and contacted to be consented, after which their results will be analyzed retrospectively.

The Termination Visit will occur on Day 182 (± 2 days) for subjects who complete the study treatment. Subjects who receive the first dose of study drug but withdraw from the study or terminate study treatment for any reason should complete all the procedures outlined for the Termination Visit.

The follow-up safety assessment may be conducted via telephone or at a study visit if needed for clinical follow-up on any safety issues). The follow-up safety assessment is to take place approximately 30 days (±5 days) after the last administration of study treatment, whether the subject completed study treatment or withdrew or terminated treatment early.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, ≥ 18 years of age
* Able to comply with medication regimen
* Subjects must have the capacity to understand and sign the informed consent form
* Heart-only transplant recipients

Exclusion Criteria:

* Subject currently enrolled in another interventional research trial
* History of hypersensitivity/adverse reaction to tacrolimus
* Patient taking Rapamycin (sirolimus) or cyclosporine (Neoral/Gengraf)
* Simultaneous multiple organ transplant recipients
* Liver transplant recipients / candidates
S9804: Vinorelbine in Treating Patients With Stage IV Melanoma

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of vinorelbine in treating patients who have stage IV melanoma that has been previously treated.

OBJECTIVES: I. Evaluate the response rate (complete or partial) of patients with disseminated stage IV melanoma treated with vinorelbine. II. Assess the qualitative and quantitative toxic effects of vinorelbine in these patients.

OUTLINE: Patients receive vinorelbine by IV over 6 to 10 minutes weekly. Treatment continues in the absence of disease progression, unacceptable toxicity, or complete response to therapy. Patients are followed every 3 months for 2 years and every 6 months thereafter.

PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed, pathologically verified, disseminated stage IV melanoma that is surgically incurable Any T, any N, M1a or M1b Must have received at least one prior chemotherapy, biologic/immunotherapy, or combination regimen for metastatic disease At least 4 weeks since prior systemic therapy Bidimensionally measurable disease by physical exam, CT scan, radionuclide scan, or plain x-ray outside previously irradiated area No brain metastases by MRI or CT scan (except completely resected brain tumors that have undergone whole brain radiotherapy)

PATIENT CHARACTERISTICS: Age: Not specified Performance status: SWOG 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: HIV negative Not pregnant or nursing Fertile patients must use effective contraception No other prior malignancy within the past 5 years, except: Adequately treated basal cell or squamous cell skin cancer Adequately treated stage I or II cancer Carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics At least 4 weeks since prior adjuvant biologic or immunotherapy Chemotherapy: See Disease Characteristics No prior adjuvant chemotherapy Endocrine therapy: Not specified Radiotherapy: At least 4 weeks since prior radiotherapy Surgery: At least 4 weeks since prior surgery
The Effect of Time-restricted Feeding on Physiological Function in Middle-aged and Older Adults

The purpose of this study is to assess the safety and efficacy of time-restricted feeding (eating within an 8-hour window) for improving physiological function (vascular, motor, cognitive and metabolic function) in healthy middle-aged and older adults.

Overall, the proposed research project has the long-term potential to influence clinical practice by establishing novel therapies for treating multiple domains of age-associated physiological dysfunction and thereby reducing the risk of clinical disease and disability.

Eligibility Criteria:
Inclusion Criteria:

* Ability to provide informed consent
* Baseline brachial flow-mediated dilation (FMD) \< 6%Δ (rationale: non-invasive screening to ensure exclusion of subjects with exceptionally high baseline endothelial function.
* Ability to perform motor and cognitive tests (e.g., can rise from a chair, walk for 2 min, climb 10 stairs)
* Women will be confirmed as postmenopausal (either natural or surgical) based on cessation of menses for \>1 year.

Exclusion Criteria:

* Ages \<55 years or ≥80 years
* Occupation that requires night-shift work or abnormal hours that would disrupt eating schedule
* Dietary habit of regularly skipping meals, already eating within a \~10 hour window, or any other form of restrictive eating.
* Unable to adhere to an 8 hour eating window for the length of the study period
* Participation in regular vigorous aerobic/endurance exercise (\>3 vigorous bouts/week)
* Not weight stable in the prior 3 months (\>2 kg weight change).
* Body mass index (BMI) \>40 kg/m\^2 (rationale: vascular function measurements can be inaccurate in severely obese subjects)
* Current smoking
* Diagnosis of a chronic clinical disease (e.g., coronary artery/peripheral artery/cerebrovascular diseases, diabetes, chronic kidney disease requiring dialysis, neurological disorders or diseases that may affect motor/cognitive functions \[multiple sclerosis, Parkinson's disease, polio, Alzheimer's disease, dementia or other brain diseases of aging\]), except hypertension and hyperlipidemia.
* Having unstable angina, acute myocardial infarction, coronary angioplasty, or aorto- coronary bypass surgery as defined by the occurrence of an event, symptom, surgery, or change in medication and/or dosage within 3 months prior to enrollment.
* Having thyroid disease that is not controlled by medications or \<3 month's use of a particular medication and/or dosage (rationale: uncontrolled thyroid diseases are associated with alterations in vascular function).
* Having past or present alcohol dependence or abuse, as defined by the American Psychiatry Association, Diagnostic and Statistical Manual of Mental Disorders
Comparison Between Different Surgical Approaches for the Treatment of INVOLUTIONAL PTOSIS

Involutional ptosis is a known eyelid pathology in which the eyelid margin obscures part of the visual axis (MRD1).Patients usually complains of visual field disturbance, deterioration in quality of life and a poor cosmetic appearance.

In clinical practice, two main surgical approaches are performed to the repair of involutional ptosis:

1. anterior approach - skin incision and levator muscle insertion advancement.
2. posterior approach - eyelid reversion and tarsectomy Both approaches has its pro's and con's, but to this date, no solid evidence exists to prove which of these techniques is superior in manner of anatomical and functional results.

in this prospective study, patients with involutional ptosis will be randomized to each of surgical approaches groups, parameters concerning surgical and post surgical periods will be evaluated.

Involutional ptosis is a known eyelid pathology in which the eyelid margin obscures part of the visual axis (MRD1).Patients usually complains of visual field disturbance, deterioration in quality of life and a poor cosmetic appearance.

In clinical practice, two main surgical approaches are performed to the repair of involutional ptosis:

1. anterior approach - skin incision and levator muscle insertion advancement.
2. posterior approach - eyelid reversion and tarsectomy Both approaches has its pro's and con's, but to this date, no solid evidence exists to prove which of these techniques is superior in manner of anatomical and functional results.

in this prospective study, patients with involutional ptosis will be randomized to each of surgical approaches groups, parameters concerning surgical and post surgical periods will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Involutional ptosis
* No previous eyelid surgery

Exclusion Criteria:

* Previous eyelid surgery or trauma
* Congenital ptosis
* Previous glaucoma filtrartion surgery
* Unwillingness for six months followup
The Anatomic Determinants of Perforation Induced Hearing Loss

The purpose of this study is to identify factors that may contribute to conductive hearing loss. Conductive hearing loss is a type that is due to a problem with the outer or middle ear. Because of this, sound does not travel through the ear normally. Perforated tympanic membranes of study patients will be photographed during the patient's routine visit using a digital otoscope. These pictures will be used to analyze perforation size as an absolute value as well as a percentage of the tympanic membrane. Audiometric results and CT scans of temporal bone (reports and images) collected as standard of care will be evaluated. Images of CT scans will be imported into a medical imaging software for creation of anatomically realistic 3D models of the middle ear and mastoid air space. Structural analysis on each 3D model will be conducted and analyzed, the volume of middle ear and mastoid air spaces will be recorded, and data points will be correlated with perforation size and location to audiogram results.


Eligibility Criteria:
Inclusion Criteria:

* Between 18 and 89 years of age
* Confirmed diagnosis of conductive hearing loss secondary to tympanic membrane perforation
* Treated for the above condition by a Duke physician
* Received both a CT temporal bone scan interpreted by a Duke radiologist and audiometry at a Duke-based facility (both tests performed within four weeks of each other), as part of standard pre-operative workup

Exclusion Criteria:

* Temporal CT scan with inadequate resolution as per determination of study staff
* Unable to provide written informed consent
* Unable to read and understand English
Walking Affecting Immunology and Quality of Life of Breast Cancer Patients

Breast cancer is the leading cancer in women worldwide. The incidence of breast cancer is increasing probably due to the prolonged life expectancy and a variety of environmental factors. Fortunately, breast cancer outcome and survival are improving due to early detection and new treatment modalities. After making first strides against breast cancer, i.e. undergoing ablation surgery, most breast cancer survivors still have to go through a series of chemotherapy, which could prolong their survival but almost inevitably downgrade their quality of life due to grueling side effects, such as lack of energy and vulnerability to infection. Numerous medical interventions have been tried by healthcare providers to alleviate these side effects, but some of them are expensive and therefore become another burden for the cancer-afflicted patients. Previous studies have already indicated that exercise generated long-term benefits to breast cancer survivors, including improved physical functions, elevated maximal oxygen intake, decreases in lethargic symptom, increase in both immune function and quality of life. Among a variety of exercises, walking is the least costly, easy-to-follow type. Through a simple, predesigned walking regimen, the investigators expected that the breast cancer patients undergoing chemotherapy could cost-effectively reap some benefit either physically or psychologically.

Cluster of differentiation 3 (CD3+), presenting at all stages of T-cell development, is a useful maker to identify T-cells. (Cluster of differentiation 4)CD4+ T cells, also known as T helper cells, play an assistant role in the immunologic process, such as maturation of B cells, activations of macrophages or cytotoxic T cells. Cluster of differentiation 8 (CD8+) T cells, known as cytotoxic T cells, responsible for destroying virus-infected cells and tumor cells. Generally, the counts of CD3+ T cells, CD4+ T cells and CD8+ T cells could be a reflection of immune system health. Short-Form 36(SF-36), a patient-reported survey, is a widely adopted tool to evaluate patient's individual health status. By means of serial blood sample collections and the delivery of SF-36 survey, this study aimed to objectively and quantitatively evaluate the effects of aerobic walking on the breast cancer patients undergoing chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

1. Stage I-II breast cancer
2. Have undergone ablative surgery
3. Going to receive chemotherapy

Exclusion Criteria:

* Difficulty walking
Electronic IIEF Validation

Questionnaires are used within urology to objectify disease burden and symptom changes during therapy. Recent technological improvements, as the smartphone and tablet, create new fill-out possibilities. However, questionnaires are only validated on paper. In order to use questionnaires for multiple platforms, electronic validation is needed. The International Prostate Symptom Score has already been validated on the smartphone. The International Index of Erectile Function (normal version of 15 questions and short version of 5 questions) is widely used within urology, however electronic validation is required for usage on electronic platforms in the future.


Eligibility Criteria:
Inclusion criteria:

* Male patients, ≥40 years of age, presenting at the outpatient clinic of Urology of the Academic Medical Center in Amsterdam.
* In possession of a smartphone, tablet or laptop/computer with internet connection.
* Access to email.
* Fluent speaking and reading the Dutch language.

Exclusion criteria:

* Change in treatment, especially erectile dysfunction at consultation which could impact the short term IIEF outcome during the cross-over time.
* Unable to provide informed consent.
* Unfit according to the medical doctor (for example cognitive problems, leading to inadequate follow-up of instructions).
Clinical and Cost-effectiveness of Group Schema Therapy for Complex Eating Disorders: the GST-EAT Study

Amongst psychiatric illnesses, eating disorders (EDs) are notoriously difficult to treat and have a high mortality rate. The average duration of an ED is 6 years and for a majority of ED patients, the disorder will become chronic. Comorbid personality pathology such as negative core beliefs and early maladaptive schemas (EMS) are strongly related to ED severity and chronicity. Enhanced cognitive-behavioural therapy for eating disorders (CBT-E) is used as the first line transdiagnostic treatment for EDs. However, CBT-E is mainly symptom-focused and does not tap into these underlying core beliefs and EMS.

Given the limited treatment effects of existing ED treatments, and the importance of comorbid personality pathology, there is an urgent need to examine more effective treatments for EDs. Group-schematherapy (GST) overcomes the limitations of CBT-E and preliminary results for treatment-resistant EDs are promising. However, robust evidence regarding the clinical and cost-effectiveness of GST for patients that do not benefit from CBT-E is not yet available. The central aim of this project is to investigate the clinical and cost-effectiveness of GST for EDs in patients with comorbid personality pathology, who do not show a clinically significant response in the first phase of CBT-E. This is relevant and important as studies examining the effectiveness of GST for EDs are scarce. This project is a joint research initiative of three academic centers (Dutch Universities), four large nation-wide mental health organizations, and two foundations for client empowerment and participation. Eligible patients will be randomized to either GST or continuation of their CBT-E treatment after failing to show a significant treatment response in the first phase of CBT-E. Based on encouraging findings from previous studies and our own pilot data, a statistically and clinically significant better outcome in terms of ED symptoms, negative core beliefs, EMS, schema modes, and quality of life is expected in the GST group compared to the CBT-E group. GST is also expected to be more cost-effective compared to CBT-E as GST may in the long run prevent chronicity in terms of long treatment trajectories and delayed recovery. Finally, with the proviso of good results for GST, we will disseminate and implement GST in the standard of care for EDs. This project thereby has great potential to improve clinical and cost-effectiveness of treatment for chronic EDs.


Eligibility Criteria:
Inclusion Criteria:

* 1) age \> 16 years;
* 2) a DSM-5 diagnosis of anorexia nervosa, bulimia nervosa, or other specified ED (atypical anorexia nervosa or bulimia nervosa with a low frequency or limited duration).

Exclusion Criteria:

* 1) not being able to speak and read the Dutch language;
* 2) being in an acute psychotic mental health state at the start of the study;
* 3) being diagnosed with an autism spectrum disorder;
* 4) having an IQ below 80, as determined with a validated instrument;
* 5) showing an early response after phase 1 of CBT-E.