cyrilzakka/clinical-trials huggingface dataset:
Transapical Beating-heart Septal Myectomy in Patient With Hypertrophic Obstructive Cardiomyopathy

The primary purpose of this study is to evaluate the feasibility, the safety and the efficacy of the transapical beating-heart septal myectomy for the treatment of hypertrophic obstructive cardiomyopathy. This is a prospective, single-arm, single-center, first-in-man study.

Surgical septal myectomy remains the gold standard for the treatment of hypertrophic obstructive cardiomyopathy. However, conventional septal myectomy is hindered by the demanding expertise that is needed to sufficient relieve the obstruction of the left ventricle outflow tract while guarantee safety. To increase the visualization and minimize the surgical injury of conventional septal myectomy, we have invented a novel beating-heart myectomy device. Through a mini-thoractomy, septal myectomy could be accomplished via a transapical access in the beating heart using the beating-heart myectomy device. The whole process of resection is monitored, navigated, and evaluated by real-time transesophageal and transthoracic echocardiography. Left ventricle outflow tract gradient and the grade of mitral regurgitation are evaluated each time after resection. Multiple resections are performed to tailor sufficient relief of left ventricle outflow tract obstruction and mitral regurgitation, while preventing iatrogenic injuries. After transapical beating-heart septal myectomy, patients is scheduled to be seen for follow-up visits at discharge (about 7 days post operation) and 3 months.

Eligibility Criteria:
Inclusion Criteria:

1. Patients whose resting or provoked left ventricular outflow tract gradient \> 50 mmHg, and maximal ventricular septal wall thickness ≥ 15 mm.
2. Patients with heart function of New York Heart Association ≥ class II.
3. Patients with drug-refractory symptoms or intolerable to pharmaceutical therapies.
4. Patients who was informed the nature of the clinical trial, consented to participate in all of the activities of the clinical trial, and signed the informed consent form.

Exclusion Criteria:

1. Patients who were pregnant.
2. Patients who had concomitant diseases such as intrinsic valvular disease or coronary artery disease that needed open-heart surgery.
3. Patients who had severe heart failure with left ventricle ejection fraction \< 40%.
4. Patients whose estimated life expectancy \< 12 m.
5. Patient who were non-compliant.
6. Patients under circumstances which were considered not suitable or prohibitive for participating the clinical trial at the discretion of the attending medical team and the researchers.
The Efficacy and Safety of a Chinese Herbal Medicine for Long COVID Associated Fatigue

This is a randomized, double-blinded, placebo-controlled clinical trial to determine the efficacy and safety of a Chinese herbal medicine (Shenlingcao oral liquid) for treating long COVID associated fatigue.

This is a randomized, double-blinded, placebo-controlled clinical trial to determine the efficacy and safety of a Chinese herbal medicine (Shenlingcao oral liquid) for treating long COVID associated fatigue. Our target population is adults (18-65 years old) with a COVID-19 infection history and have moderate to severe fatigue symptom at least 4 weeks after infection. The total sample size is 152. All participants will be randomly attributed to treatment group or placebo group in 1:1 ratio. The treatment duration is 4-week, and the follow-up period is also 4 weeks. Shenlingcao oral solution has been registered and marketed in mainland China, it is a safe product and pervious studies suggested it has anti-fatigue function. The primary efficacy outcome is the change of scores of Chalder fatigue scale (0-33 points) after 4-week treatment. The primary safety outcome is the number of adverse events. This study will be conducted in Hong Kong Baptist University Mr. \& Mrs. Chan Hon Yin Chinese Medicine Specialty Clinic and Good Clinical Practice Centre.

Eligibility Criteria:
Inclusion Criteria:

1. 18-65 years adults
2. Fulfill the long COVID diagnostic criteria by Centers for Disease Control and Prevention (CDC)
3. Chalder fatigue scale (0-11) not less than 4

Exclusion Criteria:

1. Have any medical history that may cause fatigue before COVID-19 infection, which include but not limited to cardiovascular diseases, chronic lung diseases, dyspnea, cognitive diseases, psychological diseases, chronic liver or renal diseases, cancer, etc.
2. Must chronically taking medicines that may affect the study results.
3. Severe obesity (BMI not less than 45)
4. Alcoholism or drug abuse
5. Allergy to Chinese medicine
6. Pregnancy, or plan to be pregnant, or lactating women
A Stepped-wedge Cluster Randomized Controlled Trial for Evaluating an Intervention in Patients With Stroke Tailored Education in Addition to Physiotherapist Treatment

A stepped-wedge cluster design will be used, with the duration of the trial being 50 weeks. The 'stepped-wedge ' cluster randomised trial is a form of cross-over design with unidirectional cross-over ( from control to experimental ) but with randomisation of when each cluster undertakes this transition. In the stepped-wedge design, there is a staggered roll-out of the intervention, where the time and hence the sequence of units (clusters) that will start the intervention at each period is determined by random allocation.

The randomisation occurs before the start of the trial. All clusters start the trial in a control phase with no intervention being delivered at any site, then sequentially cross over from the control group to the intervention group, until all sites are receiving the intervention. Outcomes are measured on the study participants in all clusters at every time period, hence measurement of outcomes takes place at each step in the wedge; each cluster provides data points in the control and intervention conditions allowing each site to act as its own control.


Eligibility Criteria:
Inclusion Criteria:

* The study subjects were all patients who had been hospitalised in 8 regional hospitals of Andalusian Health Service with acute cerebral stroke, clinically stable, presented an ischaemic or haemorrhagic aetiology and clinical symptoms of hemiplegia, were selectioned to receiving physiotherapy in hospitalisation, were assisted by a caregiver, had an adequate understanding of Spanish, and had given their written informed consent.
Which Apparatus for Inhaled Pentamidine?

The reference nebulizer used for pentamidine nebulization is currently the Respirgard II ®, disposable pneumatic nebulizer. Other nebulizers are on the market and appear to have comparable properties and better availability to the hospital. Several studies remark that all nebulizers with comparable properties could be used for the nebulization.The aim of our work will be to evaluate and compare the pulmonary deposition between the reference nebulizer Respirgard II ®, and one of these nebulizers available on the market, the Isoneb ®. We will measure and compare these data's for each of the nebulizers via nebulization Amikacine and urinary dosage.


Eligibility Criteria:
Inclusion Criteria:

* Be in good health

Exclusion Criteria:

* Known Tachycardia
* Renal Dysfunction
* Respiratory Diseases and history
Fiber Tolerance Study

Research shows that many people do not get enough dietary fiber through their normal diet. As a result, some nutrients are not properly absorbed into the bloodstream. The immune system however does need these nutrients. Dietary fibers are therefore important for health. Nutricia has developed a new blend of natural fibers that can help people get enough fiber.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 45 and ≤ 70 years
2. Body Mass Index (BMI) ≥ 18.5 and ≤ 29.9 kg/m2
3. Signed consent form
4. Willingness and ability to comply with the protocol
5. Good general health
6. Defecation frequency: between three bowel movements per week and three bowel movements per day within a month for screening.

Exclusion Criteria:

1. Presence or history of chronic gastrointestinal disorders (e.g. stomach ulcers, ulcerative colitis, Crohn's disease) or history of abdominal surgery with resection of the bowel (small or large intestine).
2. Presence of other medical conditions where gastrointestinal function often/probably is affected, such as:

   1. autoimmune diseases (e.g. diabetes mellitus type I, multiple sclerosis, systemic lupus erythematosus).
   2. eating disorders (e.g. anorexia nervosa, bulimia nervosa, binge eating disorder).
   3. intestinal/gastrointestinal disorder due to a stroke.
3. Chronic diseases (including but not limited to hypertension, dyslipidaemia, type 2 diabetes mellitus, thyroid disorders) that cannot be controlled with the use of medication/therapy.
4. Severe acute liver disease or chronic liver disease.
5. Severe or chronic kidney disease or need for hemodialysis.
6. Colonoscopy, irrigoscopy or other bowel cleansing, or other surgical procedures related to the gastrointestinal tract (eg. colon polypectomy, appendectomy) or for which use of systemic antibiotics within 1 month before the screening is required or scheduled during participation in the study.
7. Use of enemas, laxatives, antacids, proton pump inhibitors, prokinetics (e.g. metoclopramide, drugs that affect motility), digestive enzymes, narcotic/morphine analgesics within 1 week prior to screening or intended use during participation in the study.
8. Following a vegetarian or vegan diet.
Impact of Threatened Preterm Labour in Fetal Cardiovascular and Metabolic Programming (SHs)

The goal of this observational study is to learn about cardiac function and remodelling and metabolomic profiles in fetuses and infants who were exposed to a threatened preterm labor (TPL) during pregnancy.

The main questions it aims to answer are:

* Evaluate the impact of threated preterm labour in cardiovascular and metabolic programming in fetal life and early infancy.
* Describe prenatal and postnatal patterns of cardiac remodelling associated to threatened preterm labour.
* Describe fetal growth patterns associated to threatened preterm labour.
* Describe metabolomic profiles in umbilical cord blood associated to cardiovascular programming in fetuses exposed to threatened preterm labour.

The study's main tasks are:

* To perform an antenatal echocardiography of the exposed cohort is performed during the admission due to TPL or preterm spontaneous rupture of membranes (SRM).
* All participants are asked to fill a diet and stress questionnaire.
* To collect cord blood at the time of delivery.
* To perform a postnatal echocardiography six months after birth.

Researchers will compare fetuses and infants who were exposed to TPL to those who were not exposed to TPL during pregnancy to see if threre are any differences in cardiac function and remodelling.

Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancies.
* Study patients must be 18 years or older
* Good understanding of Spanish

Exclusion Criteria:

* Multiple pregnancies
* Major fetal defects or anomalies
* Underlying process that can cause a preterm labour
* Iatrogenic preterm labour
Combination of Cryosurgery and NK Immunotherapy for Advanced Kidney Cancer

The aim of this study is the safety and efficacy of cryosurgery plus NK immunotherapy to advanced kidney cancer.

By enrolling patients with kidney cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of the combined therapy using cryosurgery and nature killer (NK) cells for advanced kidney cancer.

The safety will be evaluated by statistics of adverse reactions. The efficacy will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).

Eligibility Criteria:
Inclusion Criteria:

* All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies after cancer recurrence
* Body tumor 1-6, the maximum tumor length \< 5 cm
* KPS ≥ 70, lifespan \> 6 months
* Platelet count ≥ 80×109/L，white blood cell count ≥ 3×109/L, neutrophil count ≥ 2×109/L, hemoglobin ≥ 80 g/L

Exclusion Criteria:

* Patients with cardiac pacemaker
* Patients with brain metastasis
* Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction
Ischemia Modified Albumin in Traumatic Brain Injury

In the current study the investigators intend to evaluate the role of Ischemia modified albumin (IMA) in the prediction of poor outcome in patients with traumatic brain injury (TBI). The investigators hypothesize that IMA will be elevated in patients with traumatic brain injury due to the excessive production of reactive oxygen species by the injured brain.

Consecutive adult patients who were admitted with TBI, blood samples were taken once written informed consent obtained. Initial evaluation on admission was performed simultaneously by ICU physician and a neurosurgical resident by means of a detailed physical and neurological examination. Demographic characteristics and vascular risk factors (hypertension, diabetes mellitus, hyperlipidemia, and peripheral ischemic disease) were recorded in details. Also, Routine blood tests, including full blood count, coagulation tests, glucose level, renal and hepatic function tests, total protein, and albumin levels; chest radiography were done.

CT scan will be performed in all the cases for the confirmation of TBI. Glasgow coma scale (GCS) was assessed on admission and recorded and assessed daily to evaluate prognosis. Patients were monitored by BP, ECG, and Pulse oximetry. All patients received standard medical treatment which included anti-edema measures mannitol 20%, 0.25-0.5 g/kg over 20 min, (not exceeding a total of 2 g/kg of body weight in 24 h) in patients with symptoms of raised intracranial pressure, and other supportive therapy for the treatment of concurrent illnesses such as hypertension and diabetes mellitus.

Biochemical Assessments:

Blood samples from TBI patients were collected immediately at the time of admission to the ICU and 24 hours later. Samples were centrifuged at 2500 RPM for 15 minutes and obtained serum samples were stored at -20oC.

IMA was measured by the colorimetric method and results were presented in absorbance units (ABSU).

Data collection

* Patients' characteristics: age, gender, BMI, cause of ICU admission.
* IMA will be measured at time of admission to ICU and 24h later
* Other data collections:

  * Hear rate (HR), systolic blood pressure,central venous pressure (CVP), body temperature. All hemodynamic parameters were measured and recorded at time of admission and every 2 hours for 24 hours
  * Length of ICU stay
  * 28-day mortality
  * Troponin I level on admission.
  * GCS at admission and daily till mortality or discharge

Eligibility Criteria:
Inclusion Criteria:

* Age more than 18 years old
* Patients with isolated head injury

Exclusion Criteria:

* Age \< 18 years old
* Pregnant patient
* Acute hepatitis or severe liver disease (Child-Pugh class C)
* Patients with recent pulmonary embolism
* Patients with unstable angina or recent myocardial infarction (MI)
* Peripheral arterial disease
* Acute stroke
* Chronic renal failure (CRF)
* Hypoalbuminemia less than 3.5
* Patients with other organs injury
* Penetrating head injury
* Head trauma more than 24 hours before admission
* Patients with known inflammatory or autoimmune diseases
Effects of Terlipressin on Renal Perfusion in Patients With Septic Shock

This open-label, randomized controlled trial aimed to investigate the effect of a fixed dose of terlipressin added to usual care vs. usual care alone on renal perfusion in patients with septic shock.

Terlipressin is a synthetic vasopressin analog with great affinity to the V1 receptor (vasoconstrictive effect), and could selectively contract efferent arterioles, increase glomerular filtration pressure and renal perfusion. The investigators conducted this open-label, randomized controlled trial to observe the effects of a fixed dose of terlipressin added to usual care vs. usual care alone on renal perfusion in patients with septic shock. Renal perfusion was monitored by renal contrast-enhanced ultrasound. The primary outcome was peak intensity (renal perfusion parameter) at 24 hours after enrollment.

Eligibility Criteria:
Inclusion Criteria:

1. Adult septic shock patients (age≥18 years old)
2. Norepinephrine dose was more than or equal to 15μg/min

Exclusion Criteria:

1. Age older than 85 years
2. Serum creatinine more than 177 μmol/L
3. Acute myocardial ischemia
4. Acute mesenteric artery ischemia
5. Pregnancy
6. Expected death within 24 hours.
Mobilization by Plerixafor of Haematopoietic Stem Cells in Children

This is a prospective Phase II, monocentre study.

The extensive chemotherapy followed of hematopoietic stem cells reinjection (HSC) is one therapeutic option which the profit is well demonstrated in the treatment of children's solid tumors. It's one of the "standard" treatment of the following tumors: neuroblastoma, metastatic medulloblastoma, Ewing sarcoma, lymphoma in relapse; and because of the big chemosensibility of paediatric cancers, stays an important therapeutic option in the rhabdomyosarcoma in relapse or metastatic, nephroblastoma, etc. The stem cells can be taken in the blood by cytapheresis after mobilization with pharmacologic molecules. At present, the reference of the mobilization treatment is the G-CSF (Granulocyte colony-stimulating factor) in monotherapy during 4 to 6 days. His inconveniences are: lasted of the treatment (4 to 6 days), reproduction of the injections (1 to 2 subcutaneous injections daily), day variability of the peak of mobilization, this hematopoietic stimulation imposes to delay the chemotherapy. The plerixafor activates a massive and fast mobilization of the HSC ( hematopoietic stem cells)(between 6 and 11 hours after the injection). Currently, it's indicated in association with the G-CSF ( Granulocyte colony-stimulating factor)in case of mobilization failure. However, his big flexibility of use could be of a big interest in monotherapy at the child. To date, there is in our knowledge no data on the use of this molecule at the child.

Schema of study: Subcutaneous injection of 240 µg/kg of Plerixafor (Mozobil ®, Genzyme) at 8 am the day of the cytapheresis. Determination of CD34+ cells circulating in h0 then every hour of h3 to h11. Taking by cytapheresis from the 5th hour of the injection if the rate of CD34+ is upper or equal in 10.106/l. If the rate of CD34+ in the blood does not reach 10.106/l after the first injection of plerixafor or if the first cytapheresis does not allow the collection of at least 5.106/kg CD34+ cells, the patient will be considered in failure and a conventional mobilization by G-CSF(Granulocyte colony-stimulating factor) will be programmed.

Eligibility Criteria:
Inclusion Criteria:

* 0 to 18 years old
* Solid malign tumor
* Lansky score ≥ 70%
* Indication of hematopoietic stem cell taking by cytapheresis for extensive chemotherapy followed by one or several reinjections of hematopoietic stem cells

Exclusion Criteria:

* Administration of hematopoietic growth factors in 8 days preceding the injection of Plerixafor.
* Contraindication in the cytapheresis or in the extensive chemotherapy.
* Clinical or biological state dissuading the realization of the cytapheresis
* Chemotherapy in 15 days preceding the injection of plerixafor or neutrophils \< 1500/mm3
Prospective Evaluation of Biliary Tissue Sampling with ERCP

The purpose of this study is to assess the safety, outcomes and performance characteristics of multiple biliary sampling techniques including but not limited to: single operator cholangioscopy (SOC) directed biopsies, transpapillary biliary biopsies (TPBx), brushings and bile aspiration for cytology and FISH in patients undergoing ERCP.


Eligibility Criteria:
Inclusion Criteria:

* Adults \> 18 years
* Diagnosis of indeterminate biliary stricture
* Scheduled clinically indicated ERCP procedure

Exclusion Criteria:

• Adults \<18 years, Children
Effect of Cap-assisted Esophagogastroduodenoscopy on Observation of Major Duodenal Papilla

Examination of major duodenal papilla (MDP) using a side-viewing duodenoscope is a golden standard. However, side-viewing duodenoscope is not available in some endoscopic centers. Cap-assisted esophagogastroduodenoscopy (Ca-EGD) using a transparent cap fitted to the tip of the scope has emerged as an alternative method for the observation of MDP. A recent study showed that complete examination of MDP could be achieved in 97% of patients. The investigators hypothesize that Ca-EGD is non-inferior to duodenoscope for the observation of MDP.

Interim analyses were planned to be performed by the data and safety monitoring board after data collection has been completed for 50% of the enrollment.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years and \< 70 years
* Patients with native MDP who underwent ERCP

Exclusion Criteria:

* Prior surgery in upper GI tract
* Prior history of endoscopic sphincterotomy
* Prior history of MDP treatment
* Known or suspected obstruction of upper GI tract
* Patients in poor condition who may not be suitable for Ca-EGD or duodenoscope
* Pregnancy or lactic women
* Inability to give informed consent
Neuropsychologic and Immunological Evaluation in Treatment of Thyroid Diseases. Is Selenium Efficient?

Graves thyrotoxicosis is a common autoimmune disease. Patients suffer at diagnosis from weight loss, increased heart rate and stress intolerance. Some patients have difficulties in regaining quality of life. Diagnosis is found through elevated thyroid hormones thyroxin, suppressed TSH (thyroid stimulating hormone) from the pituitary and elevated stimulatory antibodies, TRAb (thyrotropin receptor antibody) to the thyroid. Selenium is sparse in western Europe. This compound has important function in thyroid hormone metabolism and on the immune system. It is not known whether addition of selenium affects the well being of patients with Graves´thyrotoxicosis. The subject of this study is to investigate this

In the County of Södermanland we include 44 patients with Graves´thyrotoxicosis. They are treated with methimazole and thyroxin, and randomised to selenium or placebo. Neuropsychological investigation is performed, before medical treatment is commenced and repeated after 9 month. Serum concentration of thyroid hormon levels, autoantibodies and selenium are followed.

Eligibility Criteria:
Inclusion Criteria:

* New diagnose of autoimmune thyrotoxicosis
* biochemically proven with increased thyroxin
* low TSH and elevated TRAb/or positive scintigraphy.
* Age 18 - 55. Willing to participate -

Exclusion Criteria:

* No previous head trauma,
* No difficulties with swedish language,
* No medication which could affective neuropsychological testing,
* No planned or ongoing pregnancies.
* Normal intellectual capacity.
* No severe ophthalmopathy, or other severe disease