cyrilzakka/clinical-trials huggingface dataset:
Maternal Serum Homocysteine Levels and Uterine Artery Pulsatility Indices in Preterm Labor

Study included all pregnant women admitted with threatened preterm labor during the study period. All participants underwent estimation of maternal serum homocysteine level and assessment of uterine artery Doppler indices.

Prospective cohort study. Study approval by local ethics committee. Informed written consent. Study included all pregnant women admitted with threatened preterm labor during the study period. All participants underwent estimation of maternal serum homocysteine level and assessment of uterine artery Doppler indices.

Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancy
* More than 28 and less than 35 gestational weeks.
* Threatened preterm labor

Exclusion Criteria:

* Medical disorders complicating pregnancy
* Obstetric conditions complicating pregnancy (e.g., placenta previa, multiple gestation,PPROM, ....etc)
* Fetal anomalies or distress
Optimal Sensing in Atrial Tachyarrhythmia's Study

The aim of the study is the comparison of two different leads in their capabilities to detect episodes and duration of paroxysmal atrial fibrillation (AF) and atrial tachyarrhythmia (AT), and the rejection of far field sensing of the far field R-wave (FFRW).

The aim of the study is the comparison of two different leads in their capabilities to detect episodes and duration of paroxysmal AF and AT and the rejection of far field sensing of the far field R-wave (FFRW). The study aims to evaluate the accuracy of the detection of atrial tachyarrhythmias (ATAs). An improved detection can potentially increase the accuracy of clinical treatment decisions, based on device derived data.

Eligibility Criteria:
Inclusion Criteria:

* Patients with class I or II pacing indications for Sick Sinus Syndrome with suspected paroxysmal atrial tachyarrhythmias over the last 6 months
* Signed informed consent
* Age \>18 yrs

Exclusion Criteria:

* Severe valvular heart disease (echocardiogram less than 6 months old)
* Angina Pectoris class ≥ III
* Congestive heart failure - NYHA class ≥ III
* Left Ventricular Ejection Fraction \< 35% (less than 6 months old)
* Hypertrophic Cardiomyopathy
Two Week Study Evaluating Safety, Tolerability and Pharmacokinetics of Multiple Doses of JTK-853 in Healthy Subjects

The purpose of this study was to determine the safety, tolerability and pharmacokinetics of sequential ascending doses of JTK-853 administered for 14 days in healthy subjects and also to determine the effect of a single dose of ketoconazole on the steady-state pharmacokinetic profile of JTK-853 and its metabolite M2 (one cohort only).


Eligibility Criteria:
Inclusion Criteria:

1. Body Mass Index (BMI) ≥18.0 kg/m2 and ≤30.0 kg/m2
2. Non-smokers or subjects who have stopped smoking at least 6 months prior to the Screening Visit
3. Female subjects must be either surgically sterile or postmenopausal

Exclusion Criteria:

1. History or presence of cardiac disease, including a family history of long-QT syndrome or unexplained sudden death
2. Have used any prescription medication, herbal product, or over-the-counter (OTC) medication (except acetaminophen) within four weeks prior to Day -1
Descriptive Epidemiology of a Specialized Consultation on ADHD in Adults at the Strasbourg University Hospital

The main objective of this study is to carry out a descriptive study of the clinical and demographic characteristics of patients having consulted for a specialized opinion about ADHD in adults of the psychiatric service of the Strasbourg University Hospital.

The characteristics of patients were collected during the first consultation, by the psychiatrist, and analyzed retrospectively.

The secondary objective is to evaluate the evolution at one year in terms of follow-up, maintenance under medical treatment and perceived effects of it.

The patients who had a prescription for pharmacological treatment of ADHD were contacted between 9 and 15 months after the first consultation and responded to a questionnaire assessing the evolution.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18
* Having a specialized consultation about ADHD in adults in the psychiatric service of the Strasbourg University Hospital
* Agree with the use of medical files from the consultation for medical research

Exclusion Criteria:

* Disgree with the use of medical files from the consultation for medical research
MAnnitol for Blood Pressure Stability in HemoDialysis (MAP-HD)

This proposal will measure the effects of mannitol administration versus placebo in hypotensive-prone, adult, maintenance hemodialysis patients with respect to changes in patient symptoms and blood pressure stability.

A randomized crossover trial of hypertonic mannitol vs. placebo in IDH-prone participants will be performed over a 4-week period to determine the effect on:

* Patient symptoms
* The magnitude of intra-dialytic hypotension

The hypothesis to be tested is that the use of hypertonic mannitol will result in fewer adverse symptoms and less decline in intra-dialytic BP, compared with the use of placebo.

Eligibility Criteria:
Inclusion Criteria:

* Maintenance HD (\>90 days)
* Age ≥18y
* Thrice-weekly HD
* IDH-prone (defined as nadir intra-dialytic SBP \<100 mmHg in ≥30% of sessions in the prior 4 weeks)
* Hematocrit\>21%
* Written informed consent

Exclusion Criteria:

* Acute myocardial infarction or stroke within one month
* Pre-HD serum potassium \>6.5 mmol/L in last 4 weeks
* Pregnancy
* Institutionalized individuals
* Life expectancy \<2 months
* Planned renal transplant within 2 months
* Active enrollment in another interventional trial
* Known allergy to mannitol
Analgesic Efficacy of Blocking Nerve to Vastus Lateralis Muscle Versus Lateral Femoral Cutaneous Nerve After Knee Surgeries

This study aims to compare the analgesic efficacy and functional outcomes of blocking the nerve to the vastus lateralis (NVL) muscle versus the lateral femoral cutaneous nerve (LFCN).

Knee surgeries are associated with significant postoperative pain, which can impede early mobilization and prolong recovery. Recent advancements in ultrasound-guided regional anesthesia have enabled more targeted nerve blocks, such as the blockade of the nerve to the vastus lateralis (NVL) and the lateral femoral cutaneous nerve (LFCN)

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Both sexes.
* American Society of Anesthesiologists (ASA) physical status from I to III.
* Underwent knee surgeries under spinal anesthesia.

Exclusion Criteria:

* Pregnancy.
* Coagulopathy.
* Neuromuscular disorders.
* Hematological disorders.
* Mental disorders.
* History of multiple traumas or anesthesia drug allergies.
* Local skin infection at the block site.
* Body mass index (BMI) greater than 40.
* Opioid analgesics or abusing opioids.
Relationship Between Postoperative Tempeartive and Acute Kidney Injury

The investigators aimed to identify body temperature trajectory classes based on core temperature changes during the first 12 hours post-surgery and to explore their relationship with postoperative acute kidney injury in patients undergoing valvular heart surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent valvular heart surgery between January 2016 and July 2023 at Severance Cardiovascular Hospital of Yonsei University Health System

Exclusion Criteria:

* Patients who underwent the same surgery within 30 days,
* Patients with less than two temperature measurements within 12 hours after surgery, - Patients with missing creatinine test values before and within seven days after surgery,
* Patients who died during surgery
EARLY Assessment of MYOcardial Tissue Characteristics in OBESITY (EARLY-MYO-OBESITY)

EARLY-MYO-OBESITY-CMR is a prospective, three-center, cardiac imaging study to investigate cardiac morphology, function, and tissue phenotypes in a cohort of non-diabetic obese adults, and compare with metabolically healthy non-obese controls.

1. Transthoracic echocardiography was performed to analyze the LV morphology and function.
2. CMR was performed within 24 hours of the echocardiographic examination to assess the cardiac morphology , cardiac function, and myocardial tissue characteristics. Standard cine images were acquired to quantify LV function and volume. T1 mapping-derived ECV values were used to detect subtle diffuse fibrosis , and late gadolinium-enhanced (LGE) imaging was used to identify focal fibrosis. Native T2 values were obtained to quantify myocardial edema . Global longitudinal peak systolic strain (GLS) and e' SR were assessed by tissue tracking analysis to detect subclinical systolic and diastolic dysfunction.

Eligibility Criteria:
Inclusion criteria:

* age 18-75 years without cardiac symptoms or known cardiac diseas;
* body mass index ≥25 kg/m2

Exclusion criteria:

* coronary artery disease (coronary artery stenosis \>50% on angiography or coronary computed tomography, documented myocardial infarction, or a history of coronary artery bypass graft surgery or percutaneous coronary intervention)
* non-ischemic cardiovascular disease, such as idiopathic cardiomyopathy, valvular disease, congenital heart disease, or pulmonary heart diseas
* a left ventricular (LV) ejection fraction of\<50% on echocardiography or a history of heart failure
* arrhythmia or the presence of bundle branch block on electrocardiography
* pacemaker or defibrillator implantation
* renal dysfunction with an estimated glomerular filtration rate of \<60 mL/min/1.73 m2
* contraindications to cardiac magnetic resonance (CMR) imaging
* malignancy or life expectancy of less than 2 year
* inability to provide written informed consent
The Effect of Resistance Training on Muscle Strength and Nutritional Status in Patients With Liver Cirrhosis

The purpose is to investigate the effect of strength training on muscle strength, muscle mass and nutritional status in patients with liver cirrhosis to clarify possible metabolic and inflammatory changes during this intervention. In addition the investigator examine if the intervention is associated with fewer hospital readmission and an improved quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Cirrhosis, Child Pugh score A and B

Exclusion Criteria:

* Cirrhosis, Child-Pugh score C at inclusion
* Neurological and/or psychiatric disorder
* Pregnancy, breastfeeding
* Patients with malignancy
* Patients with hepatic encephalopathy at inclusion
* Patients with atypical diets, such as vegans
Ceramic-on-Ceramic Total Hip Arthroplasty and Squeaking: Influence of Component Design

The investigators want to examine if specific acetabular liner designs can be a contributing factor to audible squeaking associated with CoC bearings. The aim of the present study is to compare two different designed and well documented acetabular component systems with reference to squeaking and other noises from the hip.


Eligibility Criteria:
Inclusion Criteria:

* All patients scheduled for uncemented THA under the age of 65 years.

Exclusion Criteria:

* Patients with the following diagnoses of the hip: Recent femoral fracture, sequelae from older femoral fracture, acetabular fracture, and traumatic dislocation of the hip.
* Patients without ability to give informed consent and/or willingness to participate in the follow-up protocol.
* Severely impaired level of function due to other physical deficiencies than the hip.
* Mental disability that could impair a patient's decision-making capability of giving informed consent and not enabling valid data collection.
* Earlier primary THA or revision THA in the contralateral hip.
* Pathology requiring another prosthesis concept than the below mentioned.
* Body mass index greater than 35.
Effects of Acetate and Alcohol on Brain Function

This study plans to learn more about how alcohol and its metabolite, acetate, affect the brain.

This study plans to learn more about how alcohol and its metabolite, acetate, affect brain function.

Eligibility Criteria:
Inclusion Criteria-all:

1. Subjects who are age 21-55,
2. Subjects who are proficient in English ,
3. Subjects who understand the nature of the study,
4. Subjects who have signed an informed consent,
5. Subjects who are non-smoking (defined as fewer than 20 cigarettes lifetime),

Inclusion Criteria-moderate drinkers:

1. Subjects who are moderate drinkers (male:1-14 drinks per week; female: 1-7 drinks per week).
2. Subjects who have drunk at least 2 drinks in one hour in the past, and have no history of dependence on drugs or alcohol

Inclusions-AUD:

(1) Subjects who meet DSM-V criteria for lifetime history of Alcohol Use Disorder (AUD)

Exclusion Criteria-all:

1. Subjects who have a "facial flushing" response to alcohol,
2. Subjects who are pregnant or nursing,
3. Subjects who have major medical problems including diabetes, high blood pressure (\> 150/90), prior neurological or psychiatric history (schizophrenia, bipolar, or current major depressive disorder), epilepsy (alcohol withdrawal seizures is not an exclusion),
4. Subjects who have been told they have or been diagnosed with liver or kidney disease,
5. Subjects who have chronic gastrointestinal disease,
6. Subjects who are obese (BMI\>30 kg/m2),
7. Subjects who take psychoactive medications,
8. Subjects who have prior head trauma resulting in loss of consciousness \>15 minutes,
9. Subjects who have Magnetic Resonance (MR) exclusions which include claustrophobia, intracranial, orbital, or spinal metal implants, pacemakers, cochlear implants, cardiac stents or other non-MR-compatible implants or devices.
Chronic Mountain Sickness, Systemic Vascular Function

Diseases associated with chronic hypoxemia like chronic obstructive pulmonary disease (COPD) or emphysema, represent major medical and socio-economical problems and one of the leading cause of morbidity and mortality in the western countries. Recently, is has been shown that cardiovascular (CV) diseases contribute highly to the morbidity and mortality of these patients. Furthermore, increasing evidence suggest that systemic vascular dysfunction play a central role in the mediation of the increased CV risk in patients with COPD. However the underlying mechanisms of vascular dysfunction in these patients are incompletely understood. Chronic mountain sickness (CMS) is characterized by chronic hypoxemia related at least in part to hypoventilation; it affects relatively young adults, and may therefore allow to study the effects of chronic hypoxemia. The investigators therefore will assess systemic vascular function and test the hypothesis that increased oxidative stress is responsible for this dysfunction. Since polyglobulia is a hallmark of chronic hypoxemia and has been suggested to affect vascular function, the investigators will test the effects of hemodilution on vascular function. Then, the investigators will test the effects of acute oxygen application and 1 month antioxidative dietary supplement on vascular function.

Preliminary data suggest that offspring of CMS patients may display pulmonary and systemic vascular dysfunction. Antioxidant administration is know to improve vascular function. We will test the acute effect of Vitamin C in this setting.

Finally, since there is considerable inter-individual variability of pulmonary artery pressure among CMS patients and the presence of a patent foramen ovale (PFO)is increased in clinical conditions associated with pulmonary hypertension and hypoxemia, we will assess the prevalence of PFO in healthy high altitude dwellers and in CMS patients and its effects on pulmonary artery pressure at rest and during mild exercise.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Chronic Mountain Sickness and their offspring

Exclusion Criteria:

* Smoking
* Lung disease
* Arterial Hypertension
A Pilot Study to Evaluate the Systemic Inflammatory Response of Thoracoabdominal Aortic Aneurysm Repair.

The purpose of this study is to look at the systemic inflammatory response caused when patients undergo thoracoabdominal aortic aneurysm repair (TAAA). In addition, this study will look at how the inflammatory response affects the post operative healing process and post operative complications.

Patients will be invited to participate in this study prior to the TAAA repair procedure. Prior to the surgery, baseline blood and saliva samples will be collected. Following the surgery, blood and saliva samples will be collected for 48 hours. In addition, hemodynamic data (i.e. vital signs) will be collected for the first 48 hours. The patient data will be reviewed for the first 30 days for morbidity and mortality assessment.

Eligibility Criteria:
Inclusion Criteria:

* Elective TAAA repair

Exclusion Criteria:
DAS181 for Severe COVID-19: Compassionate Use

The objective of the study is to investigate the safety and potential efficacy of DAS181 for the treatment of severe COVID-19.

Each eligible subject is treated with DAS181 for 10 days and observed for 28 days from the first day of administration.

From day 1 to 10, once or twice a day, for 10 consecutive days, a total of 9 mg (7 ml) nebulized DAS181 is given. If DAS181 is given by twice a day, one vial containing 4.5 mg (3.5m1) DAS181 should be delivered with about 12-hour interval.

Eligibility Criteria:
Key Inclusion Criteria:

1. Positive for RNA of SARS-CoV-2 from respiratory specimens or blood specimens
2. Hypoxemic
3. Severe COVID-19
4. If female, subject must not be pregnant or nursing.
5. Non-vasectomized males are required to practice effective birth control methods
6. Capable of understanding and complying with procedures as outlined in the protocol as judged by the Investigator and able to sign informed consent form prior to the initiation of any screening or study-specific procedures.

Exclusion Criteria:

1. ALT or AST\> 8 x ULN
2. (ALT or AST\> 3 x ULN) and (Total bilirubin\> 2.5 x ULN or INR\> 2.0 x ULN)
3. Female subjects who have a positive pregnancy test and are breastfeeding
4. Subjects using any other investigational antiviral drugs during the hospitalization before enrollment.
5. Subjects participating in other clinical trials
6. Subjects may be transferred to a non-participating hospital within 72 hours
7. People who cannot cooperate well due to mental illness, have no self-control, and cannot express clearly
8. Severe underlying diseases affecting survival
9. Critical COVID-19 requiring mechanical ventilator at the time enrolled
Equivalence Study to Compare Two Strengths of Creon in China

This will be an open-label, randomized, multicenter, cross-over study in 60 subjects with PEI delivering data of 60 subjects for Pancreatin Enteric-Coated Capsules 25000 and of 60 subjects for Pancreatin Enteric-Coated Capsules 10000. The study will be conducted in up to 10 sites in China.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Subjects ≥ 18 years
* A) Chronic pancreatitis must be documented in the medical file by at least one of the following methods:

  * Imaging techniques (ultrasound, CT, MRI, or endoscopic ultrasound)
  * ERCP (endoscopic retrograde cholangiopancreatography)
  * Plain film of the abdomen with pancreatic calcification or
* B) Partial or total pancreatectomy ≥ 30 days prior to enrollment and without current postsurgery complications
* PEI proven by human fecal elastase ≤ 100 µg/g stool (during the screening period)
* Subjects without Creon (Pancreatin Enteric Coated Minimicrospheres) intake in the past three months
* Females of child-bearing potential should agree to continue using a medically acceptable method of birth control throughout the study and for 30 days immediately after the last dose of study drug. Medically acceptable methods of birth control include bilateral tubal ligation or the use of either a contraceptive implant, a contraceptive injection (e.g. Depo-Provera™), an intrauterine device, or an oral contraceptive taken within the past three months where the subject agrees to continue using during the study or to adopt another birth control method, or a double-barrier method which consists of a combination of any two of the following: diaphragm, cervical cap, condom, or spermicide

Exclusion Criteria:

* Subjects with a history of fibrosing colonopathy
* Solid organ transplant
* Surgery affecting the stomach or bowel, except pancreatectomy or appendectomy
* Surgery affecting the stomach or bowel, except pancreatectomy or appendectomy
* Subjects with recurrent malignant tumors of any kind
* Use of an immunosuppressive drug or chemotherapy
* Acute phase of pancreatitis
* Acute phase of pancreatitis
* Subjects who are not able or willing to ingest 90g fat/day (± 10 g fat/day) during the cross-over periods or are not willing to collect complete stools during the demarcation period.
* Subjects in an instable condition after pancreatic surgery (Karnofsky index \< 70)
* Known infection with HIV
* Pregnancy or lactation
* Current excessive alcohol intake or drug abuse
* Investigational drug intake within prior 30 days
* Known allergy against pancreatin of porcine origin or to any of the excipients of Pancreatin Enteric-Coated Capsules
* Suspected non-compliance or non-cooperation
* Celiac disease, Crohn´s disease
* Ileus or acute abdomen in the medical history
* Mental disability or any other lack of fitness, in the investigator's opinion, to preclude subject's participation in or to complete the study
* Any acute or chronic disease (i.e infectious diseases) which may limit the hospitalization, dietary adherence or stool collection or completion of the study procedures
Discordance of Obesity in Adolescent Sibilngs

This research studies the energy balance behaviors (usual eating, physical activity, sedentary) and non-shared experiences of siblings discordant for weight (one sibling is lean the other is overweight).

This research studies the energy balance behaviors (usual eating, physical activity, sedentary) and non-shared experiences of siblings discordant for weight (one sibling is lean the other is overweight). To accomplish this, siblings attend four laboratory sessions where they consume one of two types of kool-aid, smell the pizza, or rest quietly. Siblings then eat a dinner meal. Siblings also wear an activity monitor for one week and record their physical activity and sedentary activities in a habit book.

Eligibility Criteria:
Inclusion Criteria:

* between 13-17 years old
* Have discordant same gender sibling (one is below 70th percentile, one is above 85th percentile
* Speak/read English
* Moderate or greater liking of study foods

Exclusion Criteria:

* No current diagnosis of a psychiatric or eating disorder.
* No dieting, dietary restrictions, or allergies that would interfere with study participation.
* No medications or conditions that could influence taste or appetite.
* No health concern or physical disability that would limit participation in physical activity.
* No endocrine or central nervous system disorder that could produce overweight.
* No current use of tobacco or nicotine products by the adolescent siblings.
An Enhanced Home-Based Telemedicine Program Using Remote Examination Devices for Children With Medical Complexity

The purpose of this study is to assess if the benefits for children with medical complexity (CMC) receiving comprehensive care (CC) in an enhanced medical home can be further improved by enhanced telemedicine program (ETM) provided during clinic hours using mobile devices to measure temperature\& oxygen saturation, auscultate the heart \& lungs, and view the skin, throat, \& tympanic membranes in the home.


Eligibility Criteria:
Inclusion Criteria:

* Greater than or equal to 2 hospitalizations or greater than or equal to 1 ICU admission in the year before joining the comprehensive care program
* Greater than 50 percent estimated risk of hospitalization without our care as judged by the medical director

Exclusion Criteria:

* Major heart disease
* Mitochondrial disorders
* Active cancer
* Do-Not-Resuscitate (DNR) order
* Patients receiving compassionate care