cyrilzakka/clinical-trials huggingface dataset:
HARapan kiTa ECP (External Counter Pulsation) Study HARTEC Study

External Counterpulsation Therapy (ECP) is a therapeutic procedure that performed on patients with angina or heart failure to relieve the ischaemic symptoms, improve functional capacity, and quality of life. In recent studies, ECP has already proved to reduce angina symptoms, decrease degree of ischemic in heart train test. External Counterpulsation Therapy (ECP) therapy is a non-invasive technique for sequentially pressuring calf, lower thighs, and upper thighs through developed cuffs at pressure above systolic blood pressure when diastole, then deflated at systole.

This study aims to evaluate the effect of ECP therapy on cardiovascular hemodynamic, coronary perfusion, endothelial function, angiogenesis and artery genesis of the coronary blood vessel to refractory angina pectoris patients Refractory angina pectoris patients in Harapan Kita hospitals who do not respond to drugs adequately will be divided by 2 groups, control \& treatment. Inclusion criteria include age 21 - 80 years, Refractory angina CCS III-IV whom are not candidate for Re-revascularization with proven data of: have stenosis on left main more than 50%, stenosis on main coronary right artery more than 70% or stenosis more than 70% on others vessels, conducted in coronary surgery conference with conservative decision (optimal medications).

Exclusion criteria include aorta aneurysm, abdominal aneurysm, acute coronary syndrome, acute heart failure, heavy aortic regurgitation, malignant arrhythmia, blood pressure above 180/100mmHg, acute limb ischemia, DVT, active thrombophlebitis, and pregnancy.

the investigator conducts a double-blind randomized control trial. The participants will get 35 hours ECP treatment, initial treatment pressure is 300 mmHg. whilst control groups will get 75mmHg. At the end of treatment, the investigator compare the hemodynamic effect on coronary perfusion, endothelial function, angiogenesis, and coronary blood vessel arteriogenesis. Quality of Life Improvement based on WHO-5 between groups

Eligibility Criteria:
Inclusion Criteria:

* age 21 - 80 years
* Refractory angina CCS III-IV whom are not candidate for Re-revascularization with proven data of: have stenosis on left main more than 50%, stenosis on main coronary right artery more than 70% or stenosis more than 70% on others vessels, conducted in coronary surgery conference with conservative decision (optimal medica mentosa).

Exclusion Criteria:

* aorta aneurysm,
* abdominalis aneurysm,
* acute coronary syndrome,
* acute heart failure,
* heavy aortic regurgitation,
* malignant arrhythmia,
* blood pressure above 180/100mmHg,
* acute limb ischaemia,
* DVT,
* active thrombophlebitis,
* pregnancy
VT Ablation in the iCMR

The VISABL-VT is a prospective, single-arm, multi-center, interventional investigation of the safety and efficacy of radiofrequency (RF) ablation of ventricular tachycardia associated with ischemic cardiomyopathy performed with the Vision-MR Ablation Catheter 2.0 in the iCMR environment.


Eligibility Criteria:
Inclusion Criteria:

* Roll-in subjects only: Documentation of premature ventricular contractions indicated for ablation therapy (subjects may or may not be diagnosed with Ischemic Cardiomyopathy)
* Documented (ECG/EGM) spontaneous episode of sustained ventricular tachycardia within 6 months of the procedure
* Diagnosis of Ischemic Cardiomyopathy
* AAD therapy refractory, contraindicated, not tolerated, or not desired
* 18 years or older

Exclusion Criteria:

* Implanted with non-MR compatible medical devices or contraindicated for an MRI
* Presence of intracardiac thrombus (verified via CT/MRI/TEE/TTE within 48 hours of procedure - or at start of procedure)
* Thrombocytopenia or coagulopathy
* Mechanical mitral and/or aortic valve precluding access to the left ventricle
* Severe aortic stenosis
* Myocardial infarction requiring stent implantation within 90 days of procedure
* Previous cardiac surgery within 60 days of procedures
* Known/uncontrolled stroke risks
* Class IV Heart Failure
* Ejection Fraction (EF) \< 25%
* Patients with a glomerular filtration rate (GFR) \< 30
* Women who are pregnant
* Allergy to contrast agents (e.g., Gadolinium)
* Active infection
* Known or suspected myxoma
* Unstable angina
* Patients who do not tolerate anticoagulation therapy
* Previous intertribal septal patch or prosthetic atrial septal defect closure device
* Life expectancy \< 12 months
* Enrollment in another study without sponsor approval
Exercise Training in Sarcoidosis (EXTRAS Study)

Exercise intolerance and reduced health status have been found in patients with sarcoidosis and has been related to skeletal muscle weakness. The present researchers reason that skeletal muscle weakness is, at least in part, related to physical inactivity and therefore partially reversible following a structured exercise training program. Nevertheless, the effects of exercise training have never been studied in patients with sarcoidosis. Therefore, the present study is undertaken to explore the effects of exercise training in patients with sarcoidosis. A priori, the following hypotheses are formulated:

* A 12-week exercise training program improves health status, quality of life and exercise capacity in patients with sarcoidosis as compared to sarcoidosis patients without exercise intervention.
* A 12-week exercise training program improves skeletal muscle function and reduces complaints of anxiety and depression in patients with sarcoidosis as compared to sarcoidosis patients without exercise intervention.
* A 12-week exercise training program reduces circulating levels of inflammatory markers in patients with sarcoidosis as compared to sarcoidosis patients without exercise intervention.

The EXTRAS study is a prospective, randomized, controlled, 24-week crossover clinical trial in which the participants are randomly assigned to receive 12 weeks of dynamic resistance and whole-body endurance exercises followed by 12 weeks without intervention or vice versa. Consenting participants will be assessed at baseline (before randomization, week 0) and at weeks 12 and 24.

Eligibility Criteria:
Inclusion Criteria:

* Main diagnosis: previously diagnosed sarcoidosis according to the latest ATS/ERS/WASOG statement on sarcoidosis (AJRCCM 1999)

Exclusion Criteria:

* A history of neurosarcoidosis
* Undergoing structured exercise training at the time of enrollment or in the preceding 6 months
* Current participation in a pharmacological study
* Cardiovascular abnormalities on the ECG during baseline peak exercise test
* A 'normal' baseline peak oxygen uptake (≥90% of the predicted values) in combination with a 'normal' quadriceps peak torque or distance walked in 6 minutes
The Effect of Smart Sensor Combined With APP for Individualized Precise Exercise Training in Long Covid-19

The coronavirus (COVID -19) has rapidly turned into a global pandemic. For patients diagnosed with COVID-19, it caused severe damage in the upper respiratory system and systemic complications, including the cardiovascular, mental, nervous, and musculoskeletal system. Previous research has indicated that these subsequent sequelae can reduce quality of life. (A. W. Wong et al., 2020) Studies have indicated that exercise training is beneficial to improve blood pressure, reduce cardiovascular factors, reduce complications, and relieve depression (J. Galloza et al., 2017) However, the current international research on the benefits of exercise rehabilitation and the improvement of quality of life in patients who have been infected with COVID-19 is still lacking. Under the international epidemic, it is pointed out that the importance of telerehabilitation has also been advocated worldwide. Previous systematic review indicated that no matter it is nervous, muscular or cardiac system disease, the efficacy of telerehabilitation is superior to face-to-face rehabilitation. The purpose of this study is to compare the effect between the intervention of KNEESUP smart knee assistive device, and the health education in routine outpatient after diagnosis of Long Covid-19.

The purpose of KNEESUP measuring equipment used in this research is to improve the recovery rate and reduce the sequelae after treatment. KNEESUP connects the subjects and researchers through technologies such as IoT and AI. The evaluation of the rehabilitation results can be presented as a data chart, and the treatment effects are also clearly presented.

For the subject, the subject puts on KNEESUP knee pads in a long sitting position, bends the knees about 30 degrees, aligns the position of the knee pad circle with the bone, and uses the strap on the lower side, upper side, and the knee pads. After wearing, press and hold the sensor on the outer side of the knee pad for 3 seconds, and then open the mobile app. After the hardware setting and connection are completed, the evaluation and exercise can begin.

Eligibility Criteria:
Inclusion Criteria:

* symptoms last at least one month after recovery
* without physical impairment
* understood verbal or non-verbal communication
* normal cognitive function
* were willing to participate in the study and accept random allocation

Exclusion Criteria:

* diagnosed with transient ischemic attack or stroke
* had neuromuscular injury or surgery in the lower limbs in the past six months
* had heart rhythm regulator
* hospitalized during training
* had aggravated symptoms due to infection again
* had participated in other clinical trials or received other alternative treatments
Safety, Pharmacokinetics and Potential Activity of HE3286 in Obese Adult Subjects

The objectives of this study are to evaluate the safety, tolerance and pharmacokinetics of HE3286 when administered daily for 28 days to obese adult subjects and to assess potential activity of HE3286 to decrease insulin resistance. An open-label cohort of 6 patients with type II diabetes mellitus will be treated at 10 mg (5 mg BID).

HE3286 has a potentially new mechanism of action that may improve the current therapeutic options available to patients with metabolic disorders, inflammatory and autoimmune diseases. In preclinical experiments, HE3286 has shown to have anti-inflammatory activity associated with corticosteroids but without the side effects known with corticosteroid use, such as immune suppression and bone loss. HE3286 has demonstrated glucose-lowering and insulin-enhancing effects in several preclinical mouse and rat models of insulin resistance. In these experiments, HE3286 lowered blood glucose levels and prevented progression of hyperglycemia and HE3286 appeared to enhance insulin sensitivity.

Eligibility Criteria:
Main Inclusion Criteria:

* Males or females between 18 and 65 years of age
* Body mass index for females between 29 and 35 kg/m2 and no more than 37 kgm2 for males
* Fasting blood glucose level \< 126 mg/dL at screening
* 2 hour postprandial (following 75 grams glucose) blood glucose between 140 to 200 mg/dL
* Normal thyroid stimulating hormone with or without thyroid replacement therapy
* Fasting triglycerides \< 350 mg/dL
* For females of reproductive potential, agree to avoid pregnancy during the study and for 3 months following study completion, have a negative serum and/or urine pregnancy test, and use an acceptable method of birth control
* Non-smoker or has not smoked for 6 months prior to the screening visit
* No history of alcohol abuse within 2 years
* Negative drug screen at screening and baseline
* Stable weight (+/- 5%); no history of weight loss or gain (\> 10% body weight)
* Must provide voluntary, written, informed consent prior to screening evaluations
* Must be able to swallow capsules

Main Exclusion Criteria:

* Marked prolongation of QT/QTc interval or history of additional risk factors for Torsades de Pointes at screening or baseline
* Positive for HIV, HAV, HBV or HCV
* History of clinically significant cardiovascular, hepatic, respiratory or renal or endocrine disorders
* History of breast and/or prostate cancer
* Clinically significant neurological or psychiatric condition, uncontrolled hypertension, clinically significant unstable medical abnormality, chronic disease or active, serious clinical infection or condition
* Personal or family member with breast and/or prostate cancer
* Malignancy within past 5 years except for successfully treated basal cell carcinoma of the skin
* Personal and/or family history of venous thromboembolism
* History of stroke and/or heart attack
* Medication prohibited from study
Group Videoconferencing Intervention to Improve Maternal Sensitivity

Background: Early childhood development is highly dependent on the sensitive care provided by their caregivers . Interventions focused on supporting parents to improve their sensitivity have been shown to be effective . The COVID-19 pandemic has had a great impact on mental health , with pregnant women and mothers of children under one year of age being an especially vulnerable group . On the other hand, access to mental health interventions in person is restricted by confinement measures , especially group interventions, so it is relevant to have remote interventions that support this group of mothers.

Objectives: to evaluate the feasibility and acceptability of a group videoconferencing intervention to improve maternal sensitivity aimed at mother / infant dyads attended in Primary Health Care in Chile Methodology: a randomized pilot feasibility study will be carried out with a mixed design with quantitative and qualitative evaluations. A face-to-face group intervention with proven effectiveness will be adapted to videoconferencing format , then 50 dyads will be randomized in a 3: 2 ratio to receive the videoconferencing intervention ( n=30) or the delivery of educational brochures (n=20) . The feasibility and acceptability will be evaluated assessing the participation, adherence and satisfaction in a quantitative way, in addition the qualitative evaluation will be carried out through interviews and focus groups. Changes in clinical outcomes will also be evaluated: maternal sensitivity, depressive symptoms, postnatal maternal attachment and infant socio-emotional development. This pilot study will allow the identification of the key parameters for the implementation and evaluation of the intervention, which will allow the design of an effectiveness study in the future.


Eligibility Criteria:
Inclusion Criteria:

* Mother of a baby between 4 months and a year
* Attended at one of the participating primary care health centers
* Older than 18 years-old
* Handling Spanish fluently
* Have an electronic device that allows videoconferencing (computer, tablet or smart cell phone)

Exclusion Criteria:

* Mother with severe intellectual deficit or psychotic symptoms
* Participate in another early intervention at the health care center
Home-based Exercise in Chronic Kidney Disease

A home-based exercise program will be implemented in three different groups of participants: advanced chronic kidney disease, end-stage renal disease in substitutive treatment hemodialysis or peritoneal dialysis. Participants will be evaluated before the program, after 3 months and after 6 months from the starting of the program. During the first 3 months the researcher will phone them weekly to reinforce the exercise habit, and during the last three months, there will be no reinforcement. Assessment will include strength, functional capacity, health-related quality of life and depressive symptoms.

Three groups of participants (advanced chronic disease not yet in substitutive treatment, end-stage renal disease patients in hemodialysis and end-stage renal disease patients in peritoneal dialysis) will enter the study. The intervention will consist of a home-based exercise program. They will be provided with a booklet and the researcher will explain personally each of the exercises to the participants. Progression will be encouraged so that the participants should find the sessions 'somewhat hard' according to the rate of perceived exertion. Reinforcement will be high during the first 3 months (weekly phone calls, visits to the nephrology department) and none during the last 3 months. Assessment will be undertaken at three-time points: baseline, after 3 months of high reinforcement and after 3 more months of no reinforcement at all.

Assessment will include strength, functional capacity, health-related quality of life, cognitive state and depressive symptoms.

The aim of the study is to assess the effectiveness of home-based exercise to improve strength, physical function, health-related quality of life, cognitive state and depressive symptoms in advanced chronic kidney disease and end-stage renal disease (hemodialysis and peritoneal dialysis). We also aim at describing all these variables in the three different groups of patients. Adherence and satisfaction with the exercise program will be recorded at the end of the study.

Additionally, interobserver reliability will be calculated, so as reliability intraobserver in different measurement conditions (dialysis vs non-dialysis days).

Eligibility Criteria:
Inclusion Criteria:

* At least 3 months in hemodialysis treatment
* Clinically stable

Exclusion Criteria:

* Recent cardiac events (less than 3 months)
* Unable to exercise
Postoperative Gastrointestinal Dysfunction After High Risk Surgery

This study aims to find out the role of plasma I-FABP level, SOFA score, fluid balance, and vasopressor dose in predicting gastrointestinal dysfunction in high-risk postoperative patients treated in ICU

This is a prospective cohort study to find out the role of plasma I-FABP level, SOFA score, fluid balance, and vasopressor dose in predicting gastrointestinal dysfunction in high-risk postoperative patients treated in ICU. The characteristics of patients who meet the eligibility criteria were obtained. Blood sampling during admission is done for I-FABP level measurement and will be repeated after 24 hours. Blood sample which is not directly processed will be stored in refrigerator under 6-8C temperature. Evaluation of Acute Gastrointestinal Injury signs and symptoms is done. The re-evaluation is performed every day. If patients experiencing AGI signs and symptoms, monitoring and treatment based on condition are done. Routine follow-up is continued during hospitalisation in ICU. After all sample are collected, I-FABP level is assessed quantitatively using ELISA.

Eligibility Criteria:
Inclusion Criteria:

* High-risk postoperative patients
* Patients treated in Intensive Care Unit of Emergency Department or Surgery Unit in Cipto Mangunkusumo General Hospital
* Age \>18 years old
* Patients or family give written consent to follow the study

Exclusion Criteria:

* Patients with late trimester-pregnancy when admitted to ICU
* Patients undergo cardiac surgery
* Patients with gastrointestinal disorders requiring routine therapy
* Patients undergo surgery involving bowels
* Patients undergo surgical treatment for burn
* Patients treated in ICU \>24 hours before surgery

Drop-out Criteria

* Unable to obtain blood sampling for I-FABP level examination in ICU
* Unable to perform Acute Gastrointestinal Injury examination in ICU
* Patients died within \<24 hours treatment in ICU
* Patients or family decide to quit from the study
Randomized Comparison of Vaginal Self Sampling for Human Papillomavirus (HPV) Testing by Standard Versus Dry Vaginal Swabs

Human papillomavirus (HPV) assays are likely to be used in cervical cancer screening. Our objective is to simplify the method of collection of female genital tract specimens by determining if vaginal dry swabs are as accurate as the standard transport medium for HPV diagnosis.

High-risk human papillomavirus (HR-HPV) infections in women are clinically important because they have been associated with nearly all cases of preinvasive and invasive cervical neoplasia1. Genital HR-HPV related infection is common, affecting approximately 10-25% of women, depending on the population and age-groups studied2-4.

With the advance in our understanding of HPV biology and the development of technologies for HPV detection together with the poor sensitivity of a single Pap test, there has been now a growing interest concerning the potential use of HPV DNA testing as a screening tool for cervical cancer5.

Currently, there is no consensus on which sampling method is the most effective for HPV DNA testing. These last years, studies have reported that samples provided by women themselves were suitable for DNA testing and support the feasibility of self-collection for HPV DNA testing6-8. Data from these studies support that it is acceptable for the women and demonstrated that a fairly high concordance rate between the self- and physicians testing method has been achieved.

Potential advantage of self-collection is that it could improve access to health care, reduce healthcare costs and save time for patients and providers. Available data have been reported with the use of specimen transport medium (STM), but the use of dry vaginal swab may potentially offer similar reliability than standard STM. Small studies suggest that HPV test (PCR) sampled by physicians using dry vaginal swab seems to be as accurate as those performed in a standard medium for HPV detection9,10. Dry vaginal swab offers potential advantages in terms of being more convenient for collection and is less expensive than a vaginal swab placed in a transport medium.

The aim of our study is to assess the performance of self-obtained v-DRY versus "standard" v-STM and its acceptability.

Eligibility Criteria:
Inclusion Criteria:

* 20 years or older,
* First consultation in our colposcopy unit,
* Understands study procedures and accepts voluntarily to participate by signing the informed consent form (ICF).

Exclusion Criteria:

* Previous hysterectomy,
* Pregnant,
* Virgin,
* Not able to comply with the protocol study.
Correlation Between Clinical and Electrophysiological Phenotypes in a Population of Patients With Neuropathy Charcot-Marie-Tooth Disease Type 1A

This exploratory cross-sectional study proposes, firstly, to objectify in a population of Charcot-Marie-Tooth disease type 1A (CMT 1A)if there is a correlation between the recording of electrical parameters and upper limb muscle strength of the thigh and in a second step, to seek a relationship between the measured parameters.

Patients suffering from CMT 1A neuropathy will be invited to go through a series of tests such as:

* Electromyography
* Isokinetic test
* Podiatric assessment
* Functional evaluations: Hand dexterity, limbs muscles strength
* Quality of life assessment with questionnaires

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years
* Diagnosis of Charcot Marie Tooth disease, type 1A confirmed by molecular biology (duplication 17.p11.2)
* Listening and written French
* Agreement after written information, clear and honest about the purpose of the study, the nature of the tests and their possible side effects or bothersome.
* Strength of the quadriceps superior to 2/5 MMT MRC

Exclusion Criteria:

* Presence of other neurological comorbidity
* Presence of coronary artery disease unstabilized
* Peripheral neuropathy of other causes: diabetes, monoclonal gammopathy, malignancy, solid cancer, systemic autoimmune disease (lupus, Sjögren's disease, Wegener sarcoidosis ...), infectious disease (viral hepatitis, HIV ...), drugs known to be responsible for iatrogenic neuropathy.
* Gait trouble of other origin
* Patients unable to give their consent.
* Intellectual deficit that does not allow to comply with tests