cyrilzakka/clinical-trials huggingface dataset:
Cardiovascular Effects of Selective I(f)-Channel Blockade

The study compares three treatment modalities in a human model of Postural orthostatic tachycardia syndrome (POTS): beta-blockers, I(f)-blockers, and placebo.

Elevated heart rate may lead to cardiac disease in the long-term. Therefore, drugs lowering heart rate are useful. Beta-blockers are an established treatment modality. They not only lower heart rate but also contractility, which might be undesirable in certain tachycardic disorders.

Postural orthostatic tachycardia syndrome (POTS) patients complain about dizziness, weakness, headache, lightheadedness, fatigue, nausea, and presyncope. In some patients there is elevated heart rate even during supine rest. In POTS patients it is preferable to lower heart rate without reducing cardiac contractility which can be achieved by using so-called I(f)-blockers. Thus, they might be superior to beta-blockers in POTS.

In our study, we artificially generate POTS in healthy male subjects for about 48 hours. We want to compare the cardiovascular effects and orthostatic tolerance of the following treatments: beta-blocker, I(f)-blocker, and placebo.

Moreover, we will quantify changes in cardiovascular autonomic regulation brought about by I(f)-blockade versus placebo.

Eligibility Criteria:
Inclusion Criteria:

* healthy male
* age 18-40 years
* BMI: 18-30 kg/m²
* arterial blood pressure \<=160/100 mm Hg
* co-operativity
* voluntariness

Exclusion Criteria:

* conditions in which treatment might be ineffective or insecure
* co-medication within the last 4 weeks
* participation in another clinical trial within the last 4 weeks
* unability to understand the study's aim
* drug or alcohol abuse
* secondary hypertension
* creatinine \> 130 μM (1.47 mg/dl)
* GOT/GPT \> 2 times normal
* GGT \> 3 times normal
* contraindications against reboxetine, beta-blocker, ivabradine
* asthma, psoriasis
* diabetes
* heart failure (NYHA III or IV)
* coronary artery disease
* peripheral occlusive disease
* cerebrovascular disease
* ventricular extrasystoles (Lown III-V)
* atrial fibrillation
* resting heart rate \<60/min
* neurologic/psychiatric disorder
* pulmonary hypertension
* dysthyroid metabolism
Nutritional Intervention in Geriatric Oncology

Older patients with cancer are poorly treated or not treated at all. A previous study in the south west of France (364 patients) showed that patients receiving chemotherapy had short survival times which strongly depended on nutritional status. In this study, the researchers would like to evaluate if individual dietician follow-up at each cycle of chemotherapy increases survival of patients at risk of undernutrition.

Undernutrition in patients with cancer also called tumour cachexia concerns about 50% of this population during tumour progression. It's well established that loss of weight is poor prognosis factor in patients treated by chemotherapy in digestive cancers. Small number of studies assessing undernutrition, its management and consequences on prognosis were published. Previous study lead by our team in oncogeriatry in Aquitaine accrued 364 patients more than 70 years old and treated by chemotherapy for cancer. Median follow-up at 13 months for intermediary analysis about 155 first patients revealed at first geriatric evaluation, 28 pts (18.7%) were malnourished (MNA\<17) and 72 pts (48.0%) at risk of malnutrition (MNA 17 to 23.5). At one year median follow-up major mortality was observed in 20 (71.4%) undernourished patients, 34 (47.2%) patients at risk of undernutrition and 13 (26.0%) patients without nutritional problem. According to consensus undernourished patients received nutritional support. Management of patients at risk of malnutrition is not clear. Our hypothesis is that nutritional support in patients at risk of undernutrition detected during geriatric evaluation could increase survival, safety, functional status and quality of life of patients. We construct an open multicentric two group randomized trial comparing usual nutritional management versus usual nutritional management plus nutritional intervention with dietician at each cycle of chemotherapy in 6 first cycles to maintain 30 kcal/kg/d and 1.2 protein/kg/d. Principal objective is to increase survival at 1 year with 10%. According to O'Brien and Fleming method we have to include 410 pts in each group, about 1640 pts will be evaluated by MNA test.

Eligibility Criteria:
Inclusion Criteria:

* Over 70 years of age
* Histologically proven cancer
* Treatment by chemotherapy
* Risk of undernutrition according to MNA score between 17 and 23.5
* ECOG ≤ 3
* Life expectancy \> 12 weeks
* Patient affiliated with the French social security regimen
* Written informed consent

Exclusion Criteria:

* MNA score under 17 or over 23.5
* Geographic, psychological, or social conditions potentially hampering compliance with the study protocol
* Symptomatic central nervous system (CNS) metastases
* Chemotherapy treatments not published as standard protocols
* Treatment that does not allow geriatric evaluation and dietician follow-up.
Reducing Arrhythmia in Dialysis by Adjusting the Rx Electrolytes/Ultrafiltration, Study A

The primary purpose of this study is to test the feasibility of trials which change the dialysate (dialysis bath prescription) of potassium and bicarbonate according to a standardized algorithm and according to the results of blood testing performed prior to each dialysis. In addition, the trial will provide estimates of the extent to which performing dialysis in this way lowers the risk of abnormal heart rhythms in people with kidney failure who are being treated with chronic hemodialysis.

Within four weeks of consent, subjects will have an Implantable Loop Recorder (ILR) (Medtronic LINQ) device implanted. Subjects will be given a transmitter/charger and a Patient Care Assistant which they will be required to keep for the duration of their participation in the study. ILR tracings will be uploaded automatically and reviewed by the study team for the occurrence of clinically significant arrhythmia.

Following ILR implantation, subjects will have 1 month of standard dialysis and will crossover in random order between four month-long periods of dialysis guided by the results of the point of care testing. Whole blood will be obtained by dialysis staff and immediately tested on a point of care chemistry analyzer according to the manufacturer's protocol prior to each dialysis session. The randomized intervention periods will include algorithms that alter the potassium bath in order to a) maximize potassium removal or b) minimize potassium removal as well as a second set of algorithms that alter the bicarbonate bath in order to c) limit acidosis or d) limit alkalosis.

Eligibility Criteria:
Inclusion Criteria:

* Maintenance hemodialysis therapy for end-stage renal disease
* Age 18-85 years (subjects between 18-40 years old will be required to have at least one of the following: history of congestive failure, diabetes, coronary or peripheral vascular disease, or arrhythmia)
* \>30 days since dialysis initiation
* Ability to provide informed consent

Exclusion Criteria:

* Expected survival \<6 monthsRenal transplant, transfer to home or peritoneal dialysis, or to non-study hemodialysis facility anticipated within 6 months
* Prisoners or cognitive disability preventing informed consent
* Pregnancy. A pregnancy test will be required for women of child bearing potential prior to enrollment. A pregnancy test will not be required for women past the age of child-bearing potential \>55 years old, women with a history of surgical sterilization, or for women \<55 years of age who have not had a menses within the past 12 months.
* Skin condition, immune dysfunction, history of multiple infections or other condition which increases risk of local infection with ILR placement
* Bleeding disorder or anti-coagulation that cannot be reversed for ILR placement
* Existing pacemaker, implantable monitor or defibrillator which precludes device placement
* Chronic, persistent AF. Defined as the presence of persistent AF on all available EKGs at time of recent screening.
* Hemoglobin \<8 g/dL-Serum K \>6.5 or \<3.5 mEq/L within 30 days
Effectiveness of Delirium Care Protocol After Cardiac Surgery

This study was conducted as a quasi-experimental study to determine the effectiveness of the postoperative delirium prevention, diagnosis and intervention protocol in patients monitored in the intensive care unit after cardiac surgery.

This study was conducted as a quasi-experimental study to determine the effectiveness of the postoperative delirium prevention, diagnosis and intervention protocol in patients monitored in the intensive care unit after cardiac surgery. The research was conducted at Antalya Training and Research Hospital between 06.03.2023 and 22.05.2023. The sample of the study consisted of 64 patients who underwent cardiac surgery and met the inclusion criteria. Within the scope of the study, patients were divided into two groups: control (32) and intervention (32). While the patients in the intervention group received care in line with the "Postoperative delirium prevention, diagnosis and intervention protocol", the patients in the control group received routine nursing care for delirium. The data of the study were collected using the Patient Identification Form, Acute Physiological and Chronic Health Evaluation, Glasgow Coma Scale, Richmond Agitation-Sedation Scale, Confusion Assessment Scale in the Intensive Care Unit, Nurse Diagnosis Form, Information Assessment Form for Postoperative Delirium (Pretest-Posttest) and Postoperative Delirium Prevention, Diagnosis and Intervention Protocol Checklist. In the first stage of the study, which consisted of three stages, the incidence of delirium in the control group patients receiving routine nursing care and the delirium diagnosis status of the nurses were determined. In the second stage, nurses were given training on postoperative delirium prevention, diagnosis and intervention protocol, and a preliminary study of the protocol was conducted. In the third phase, which is the last phase, patients in the intervention group received care in line with the "Postoperative Delirium Prevention, Diagnosis and Intervention Protocol".

Eligibility Criteria:
Inclusion Criteria:

* Volunteering to participate in the study,
* Being 18 years or older,
* Ability to speak and communicate in Turkish,
* Having undergone cardiac surgery and being on the first postoperative day,
* Richmond Agitation and Sedation Scale (RASS) score of -3 and above,
* Having a Glasgow Coma Scale (GCS) score of 8 and above,
* Not having a serious psychiatric or neurological diagnosis,
* No serious visual or auditory problems

Exclusion Criteria:

* Undergoing surgeries other than cardiac surgery (such as abdominal endovascular aneurysm repair, thoracic endovascular aneurysm repair, deep vein thrombosis, peripheral artery disease, carotid endarterectomy),
* Previous cardiac surgery,
* Postponing or canceling the surgery,
* No preoperative admission to the cardiovascular surgery service and no emergency surgery.
Microbial Soy Milk Consumption, Inflammation and Renal Function Among Type 2 Diabetic Patients With Nephropathy

The aim of the present study was to determine the effects of fortified soy milk with L. planetarium A7 on a cytokine receptor, an adipokine and renal function biomarkers in type II diabetic patients with nephropathy.


Eligibility Criteria:
Inclusion Criteria:

* Adults
* Type 2 diabetic patients with stages 1 and 2 of nephropathy (defined as meeting criteria including fasting blood glucose \>126 mg/dL, hypoglycemic agents, or insulin intake, proteinuria \>300 mg/day, and glomerular filtration rate \>90 mL/min)

Exclusion Criteria:

* pregnancy or lactating in women
* allergy or intolerance to soy milk or avoidance of soy milk consumption
* smoking, alcoholism
* recent antibiotic therapy and using of supplements containing vitamins and minerals
* any medical condition such as inflammatory bowel disease, infection, liver disease and rheumatoid arthritis.
CMR Repeatability in STEMI

The investigators propose to conduct a study to measure the reproducibility of CMR parameters that have been used to predict outcome following PPCI: infarct size, left ventricular volumes, myocardial salvage, microvascular obstruction (MVO) and myocardial oedema.


Eligibility Criteria:
Inclusion Criteria:

Participant may enter study if ALL of the following apply

1. ST segment myocardial infarction as defined by ECG (by 2 contiguous limb leads with \>1 mm ST-segment elevation, or \>2 mm ST-segment elevation in contiguous precordial leads, or new LBBB) and \> 20 minutes of cardiac chest pain
2. Written informed consent

Exclusion Criteria:

Participant may not enter study if ANY of the following apply

1. Contraindication to MRI (implanted pacemaker/ defibrillator, ferromagnetic metal implant/ injury, claustrophobia, obesity/ too large for CMR scanner)
2. Known allergy to gadolinium
3. Chronic atrial fibrillation
4. Renal impairment with eGFR \<30
5. Cardiogenic shock
6. Patients with special communication needs
A Retrospective, Multicenter, Controlled Clinical Trail: to Evaluate the Clinical Efficiency of Intracranial Aneurysm Assistive Software in the Morphological Measurement

the goal of this clinical trail is to evaluate the clinical efficiency of intracranial aneurysm assistive software in the morphological measurement. The trail is designed as retrospective, multicenter, controlled clinical trail. Collecting probable cases images retrospectively according to inclusion criteria and exclusion criteria strictly. Controlling bias strictly, to make sure the measurement of intracranial aneurysm assistive software is evaluated reliably and precisely. In our trail, six physicions were recruited, containing three neuroradiologists, two radiologists and a residents. Software-assistant planning controls against no software-assisant planning，which aims to evaluate the improvement of morphological measurement efficiency of physicians.


Eligibility Criteria:
Inclusion Criteria:

1. aged 18-75y, no gender limitation.
2. non-ruptured intracranial saccular aneurysm with specific intracranial CTA images.
3. Intracranial aneurysm was not treated.

Inclusion criteria of images:

1. the number of detector rows of Computed Tomography(CT) is more than 16 rows.
2. slice thickness ≤ 0.625mm, whole-brain image is considered.
3. Both plain scan sequences and enhancer sequence are required.

Exclusion Criteria:

1. combined with cerebral hemorrhage;
2. combined with cerevascular malformation or cerebral occupying lesion;
3. fusiform aneurysm or dissection aneurysm;
4. intracaverous internal carotid artery aneurysm;

Exclusion criteria of images:

1. none DICOM format;
2. quality score less than 3 scores;
3. metal artifacts existance.
Electro Flo 5000 and Vest Therapy

It is the goal of the proposed study to compare the efficacy, as assessed primarily by sputum weight, of these two different devices (the Electroflo 500 and VEST therapy) for airway clearance (AC) in CF patients with mild to moderate lung disease, who have stable lung health and perform AC at home as part of their routine therapeutic regimen.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of CF established by standard criteria (sweat chloride \> 60 mmol/L and/or two alleles affected by gene mutations know to be associated with CF).
2. Age older than 12 years.
3. Known to consistently produce sputum.
4. Currently on a home therapeutic regimen that includes some form of AC performed at least 2 times daily.
5. FVC and FEV1 \> 40%-predicted, and with stable lung function (no greater than a 10% variation in lung function parameters over the preceding 3 months).

Exclusion Criteria:

1. Hospitalization for CF pulmonary complications in the 2 months preceding enrollment.
2. Hemoptysis \> 60 cc in a single episode in the 4 weeks preceding enrollment.
3. Chronic chest pain.
4. Participation in another interventional clinical trial in the previous 30 days. -
Effectiveness of Instrumental Rehabilitation in Patients With Adhesive Capsulitis

The aim of this study is to evaluate the effectiveness of robotic training compared to conventional rehabilitation in patients with AC.

Nowadays, rehabilitation focuses on functional work during physiotherapy sessions to improve the patient's autonomy.

In the era of new technologies, robotics and virtual reality have shown great interest in functional rehabilitation and cortical reorganization.

Eligibility Criteria:
Inclusion Criteria:

* Patients \>18 years of age
* Shoulder pain and/or movement limitation
* Idiopathic AC or associated with confirmed systemic disease (e.g., diabetes or dyslipidemia)

Exclusion Criteria:

* Cognitive impairment
* History of surgery
* Fracture or dislocation of the shoulder
* History of shoulder tendinopathy
* History of inflammatory or degenerative disease
* Infection
* Neurological disease (Parkinson's disease, stroke, multiple sclerosis, neurological
* Manipulation under anesthesia, hydro dilation, platelet rich plasma or hyaluronic acid infiltration within the last 6 months
Endometrial Safety of a Low Dose of Vagifem® in Postmenopausal Women With Atrophic Vaginitis

This trial is conducted in Europe. The purpose of this study is to evaluate endometrial safety of intravaginal estradiol (Vagifem®) in healthy postmenopausal women having atropic vaginitis.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women whose last menstruation was at least two years prior to the time of screening
* At least 1 urogenital symptom (vaginal dryness, vaginal and/or vulvar irritation/itching, vaginal soreness, dysuria, dyspareunia and vaginal bleeding associated with sexual activity
* Generally healthy

Exclusion Criteria:

* Exposure to exogenous sex steroid hormones (estrogen and/or progestin hormone replacement therapy) within past 3 months
Patch-free Occlusion Therapy

The purpose of the study is to determine whether a patch-free occlusion therapy leads to better visual outcomes in young children with amblyopia than standard-of-care occlusion therapy with an adhesive patch and whether this is associated with better adherence to the treatment.

This is a single-site randomized clinical trial to compare patch-free occlusion therapy with standard-of-care occlusion therapy with an adhesive patch in young children with amblyopia. Participants will be referred from local pediatric ophthalmologists. Following informed consent, children will complete baseline testing to confirm eligibility and provide pre-treatment measurements of visual acuity, suppression, stereoacuity, motor skills, self-perception, and quality of life. Eligible children will then be randomly allocated to either patch-free occlusion therapy or standard-of-care occlusion therapy with an adhesive patch.

Children will participate in their assigned occlusion therapy at home for 12 weeks (primary outcome). Adherence will be objectively monitored with a Theramon sensor. Vision will be re-assessed at 6 weeks and all tests will be repeated at 12 weeks. The patch-free occlusion group will have an option to continue the patch-free occlusion for and additional 6 or 12 weeks (24 weeks total). The standard-of-care occlusion group will be offered the opportunity to use the patch-free treatment at the 12 week visit through 24 weeks. Children who choose to remain in the study beyond the 12 week primary outcome visit will have vision reassessed at 18 and 24 weeks.

The primary analysis will be a comparison of improvement in amblyopic eye visual acuity (baseline-12 weeks) between the patch-free occlusion group and the standard-of-care patching group. Secondary analyses will include comparisons adherence to each treatment, comparison of the proportion of children in each group with visual acuity ≤0.1 logMAR (recovered) at 6 and 12 weeks visit and 95% CIs (at 6 and 12 weeks), comparisons of changes in extent of suppression, depth of suppression, stereoacuity, motor skills standard scores, self-perception scores, and PedEyeQ domain scores. Associations among hours of treatment, changes in visual acuity, suppression, and stereoacuity, will be explored and modeled for dose-response relationships. In exploratory analyses, we will examine whether there are additional improvements in visual acuity, suppression, or stereoacuity between 12 and 24 weeks for the patch-free group (12, 18, and 24 weeks means and 95% CIs).

Eligibility Criteria:
Inclusion Criteria:

* 3-10 years (3-7 primary cohort)
* male and female
* strabismic, anisometropic, or combined mechanism amblyopia (visual acuity: 0.3-0.8 logMAR)
* interocular visual acuity difference ≥0.3 logMAR
* wearing glasses (if needed) for a minimum of 8 weeks with no change in visual acuity at 2 visits ≥4 weeks apart
* child's ophthalmologist and family willing to forgo standard patching treatment during the study

Exclusion Criteria:

* Prematurity ≥8 wk
* coexisting ocular or systemic disease
* developmental delay
* myopia \> -3.00D
Long-Term Assessment of the Safety and Performance of the NuVasive Simplify Disc at Two Levels

A prospective, multicenter post-market clinical follow-up study to evaluate the 10-year long-term safety and effectiveness of the Simplify Disc at two levels in subjects who were enrolled in the IDE study (NCT03123549) and/or post approval study (NCT04980378).


Eligibility Criteria:
Inclusion Criteria:

1. Subject was enrolled in the Simplify Disc IDE (NCT03123549) and/or PAS (NCT04980378) at a participating study site
2. Patient understands the conditions of enrollment and is willing sign an informed consent form to participate in the study

Exclusion Criteria:

1. Subject had an SSI at the index level during the IDE study (NCT03123549) or the PAS (NCT04980378)
2. Subject was withdrawn or withdrew consent to participate in the IDE study (NCT03123549) or PAS (NCT04980378)
Efficacy and Safety Study of 610 in Patients With Severe Asthma

The primary objective of the study is to evaluate the efficacy and safety of 610 in Chinese adults with severe asthma.

The total duration of study per patient is approximately 66 weeks, including 6 weeks of screening period, 52 weeks of treatment period and 8 weeks of follow-up period.

Eligibility Criteria:
Inclusion Criteria:

1. Able to give written informed consent prior to participation in the study.
2. Male or female adults ages 18 to 75 years old when signing the informed consent.
3. Documented diagnosis of asthma for at least one year prior to screening.
4. History of physician-diagnosed asthma requiring treatment with ICS and at least one other control medication for at least 6 months prior to screening.

Exclusion Criteria:

1. Presence of a known pre-existing, clinically important lung condition other than asthma.
2. Severe asthma exacerbation within 4 weeks prior to randomization.
3. Subjects with any eosinophilic diseases other than asthma.
4. Known, pre-existing severe or clinically significant cardiovascular disease.
5. known, pre-existing other concurrent clinically significant medical conditions that are uncontrolled with standard treatment.
6. Subjects who have active Hepatitis B, Hepatitis C or HIV infections as determined by positive results at Screening.
7. Subjects with allergy/intolerance to a monoclonal antibody.