cyrilzakka/clinical-trials huggingface dataset:
Study of the Benefit of Exercise and Aminoacid Supplements in Cirrhotic Patients

This is a pilot study including 20 cirrhotic patients that will be randomized to receive during 3 months leucine vs leucine plus a programme of physical exercise specially designed for cirrhotic patients. The hypothesis is that physical exercise in cirrhotic patients could increase muscle mass (and therefore glutamine synthetase activity leading to a higher blood ammonium clearance) and quality of life. Safety of physical exercise in cirrhotic patients will be strictly assessed.


Eligibility Criteria:
Inclusion Criteria:

* compensated liver cirrhosis.

Exclusion Criteria:

* hepatocellular carcinoma,
* active alcoholism (less than 1 year),
* decompensated cirrhosis,
* variceal bleeding less than 3 months,
* contraindication for exercise.
VALOR: The Talent Thoracic Stent Graft System Clinical Study

A Descending Thoracic Aneurysm is a bulge in the aorta. The aorta is a large blood vessel that carries blood away from your heart to organs in the rest of your body. Your aneurysm is caused by a weakening in the artery wall. If left untreated, this bulge may continue to grow larger and may ultimately rupture (break open) or extend in size to seriously affect other major arteries in the area. In this Research Study a device will be placed inside your aorta to block the weakened part of the artery wall from the circulatory system. Information will be collected on the performance for the device for 5 years.


Eligibility Criteria:
Talent Captivia Inclusion Criteria

1. Patient is at least 18 years of age.
2. Patient is a surgical or non-surgical candidate
3. Patient has a:

   1. Fusiform focal TAA AND / OR
   2. Focal saccular TAA or penetrating atherosclerotic ulcer.
4. Subject's anatomy must meet all of the following anatomical criteria:

   1. iliac/femoral access vessel morphology that is compatible with vascular access techniques, devices, and/or accessories
   2. non-aneurysmal aortic diameter in the range of 18-42mm; and
   3. non-aneurysmal aortic proximal and distal neck lengths =/\>20mm
5. Thoracic aortic lesion is confirmed, at a minimum, by diagnostic contrast enhanced computerized tomography (CTA) with optional 3-D reconstruction, and/or contrast enhanced Magnetic Resonance Angiogram (MRA) obtained within the previous three (3) months prior to the implant procedure.
6. Subject or subject's legal representative understands and has signed an Informed Consent approved by the Sponsor and by the IRB for this study.
7. Patient must be able and willing to undergo follow-up imaging and examinations postoperatively up to 6 months.

Talent Captivia Exclusion Criteria

1. Planned placement of the COVERED (top edge of fabric) portion of the stent graft requires implant to occur in zones 0 or 1
2. Pregnant female
3. Patient has a connective tissue disease (e.g Marfan's syndrome, medial degeneration).
4. Patient has a mycotic aneurysm or is suspected of having systemic infection.
5. Patient has a history of bleeding diathesis, coagulopathy, or refuses blood transfusions.
6. Patient is currently participating in an investigational drug or device clinical trial that would interfere with the Talent Captivia protocol endpoints or follow-up.
7. The patient has known allergy or intolerance to the device components.
8. The patient has a known hypersensitivity or contraindication to anticoagulants or contrast media, which is not amenable to pre-treatment.
9. The patient has another medical condition, which may cause them to be non-compliant with the protocol, confound the data interpretation, or limited life expectancy of less than 6 months.
Incidence and Prevention of Hypothermia in Newborns Bonding During Caesarean Section

This study should evaluate whether newborns during cesarean section are endangered to get hypothermic while bonding on the mothers chest.

Therefore, the investigators want to investigate the effects of active cutaneous warming of the mothers and babies during intraoperative bonding. The investigators plan to enroll 40 parturients scheduled for elective caesarean section to receive passive insulation or forced-air skin surface warming. The investigators will measure core temperature of the newborns and their mothers. The investigators hypothesize that newborns became most often hypothermic without active warming during the bonding procedure and that active warming will be able to decrease the number of hypothermic newborns significantly.

Little is known about the thermoregulatory effects on babies when bonding on the chest of the mother during caesarian section. The aim of our study is to evaluate whether newborns during cesarean section are endangered to get hypothermic while bonding on the mothers chest. The investigators want to investigate the effects of active cutaneous warming of the mothers and babies during a 20 min intraoperative bonding period. The investigators plan to enroll 40 parturients scheduled for elective caesarean section under spinal anaesthesia to receive passive insulation or forced-air skin surface warming. The investigators will measure core temperature of the newborns and their mothers. The investigators hypothesize that newborns became most often hypothermic without active warming during the bonding procedure and that active warming will be able to decrease the number of hypothermic newborns significantly.

Eligibility Criteria:
Inclusion Criteria:

* parturients undergoing planned, elective cesarean section under spinal anaesthesia
* mothers classified as American Society of Anaesthesiologists (ASA) status I or II
* written informed consent

Exclusion Criteria:

* mothers younger than 18 years
* mothers classified as American Society of Anaesthesiologists (ASA) status III or higher
* caesarean section planned under general anaesthesia.
* any expected problems with the newborn such as:

  * gestation date \< 36 or \> 42 week
  * placenta previa, abruption of placenta, green amniotic fluid, amnion infection syndrome or any abnormalities in cardiotocography (CTG)
Prospective Longitudinal Study of Heylo™ for People Living With a Stoma

This study aims to longitudinally evaluate the usage and long-term benefits of the CE-marked device, Heylo™, a digital leakage notification system for people with intestinal stomas. The system, which includes a smartphone application, an adhesive sensor layer, and a Bluetooth transmitter, notifies users of changes in their baseplate status, potentially reducing stoma effluent leakage and improving quality of life. The physical Heylo™ device, is part of the Coloplast Charter telehealth service.


Eligibility Criteria:
Inclusion Criteria:

1. Are you at least 18 years old? \[Yes/No\]
2. Do you have an ileostomy or a colostomy? \[Yes/No\]
3. Have you used Heylo™ for less than seven days? \[Yes/No\]

Exclusion Criteria:

1) Do you have a stoma reversal planned (surgery date within the next 6 months)? Yes/No\]
36-month Special Drug Use Surveillance on Frequency of Bone Fractures With Sodium Risedronate 75 mg Tablets

The purpose of this survey is to evaluate the effectiveness (endpoints: frequency of bone fractures, percent change in bone density, etc.) and safety of administration of sodium risedronate tablets 75 mg for 36 months in osteoporosis patients in daily medical practice.

This special drug use surveillance was designed to evaluate the effectiveness (endpoints: frequency of bone fractures, percent change from baseline in bone density, etc.) and safety of sodium risedronate 75 mg tablets in osteoporosis patients in daily medical practice.

The usual dosage for adult is 75 mg of sodium risedronate administered orally with a sufficient volume (approximately 180 mL) of water once monthly after waking.

Eligibility Criteria:
Inclusion Criteria:

Osteoporosis patients who meet all the following criteria:

1. Patients with 1 to 4 confirmed vertebral body fractures in the T4-L4 region by thoracic and lumbar spine X-ray examination at screening (within 3 months before the start of administration of sodium risedronate 75 mg tablets)
2. Male and postmenopausal female patients aged 50 years or older
3. Ambulatory outpatients

Exclusion Criteria:

-
Cystic Fibrosis Related Diabetes

Cystic Fibrosis (CF) is a chronic disease characterized by recurrent pulmonary infections and exocrine pancreatic insufficiency. The vast majority of patients with CF will develop pancreatic endocrine insufficiency over time manifested as altered glucose metabolism. The presence of overt diabetes in patients with CF is associated with adverse clinical outcomes.

The underlying pathophysiology of cystic fibrosis related diabetes (CFRD) is still a matter of investigation. In addition to localized tissue damage developing similar to that of the exocrine pancreas, additional mechanisms may be involved. The investigators have recently shown that insulin secretion in patients with CF is significantly altered prior to the development of diabetes. This phenomenon is associated with reduced secretion of gut derived incretins (specifically GIP). The blunting of incretin induced insulin secretion (whether due to a deranged interaction of gastrointestinal contents with enterocytes resulting in reduced secretion or due to rapid clearance of such peptides) may be a major underlying driver of altered glucose metabolism in such patients.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* No diabetes based on screening OGTT
* No C/I for use of the medications
* Normal kidney function
* Willing and able to participate

Exclusion Criteria:

* Use of anti-hyperglycemic medications
* Acute illness or infection at enrollment
Esomeprazole for Treatment of GERD in Pediatric Patients

To look at the safety and improvement in symptoms of a once a day dosing of esomeprazole in children 1 to 11 years old with inflammation of their esophagus or food pipe ("esophagitis") caused by gastroesophageal reflux disease (GERD) and diagnosed by endoscopy.

To verify the healing of the esophageal inflammation if the endoscopy reveals cuts in the lining of the food pipe.

To collect information that will describe the psychological, social, and economic effects on the primary caregiver of raising children ages 1 to 5 years old with GERD.


Eligibility Criteria:
Inclusion Criteria:

* Patients' parents/guardians must provide written informed consent prior to the execution of any study-related procedures.
* Patients who are able to comprehend their involvement in a clinical study, including risks and benefits, (typically ≥6 years of age) must have assent documented by study personnel prior to any study-related procedures.
* Patients must be diagnosed with endoscopically proven GERD by the investigator during the screening period or have a previous (within 2 weeks prior to Visit 1) diagnosis of erosive esophagitis by endoscopy and are candidates for PPI therapy.

Exclusion Criteria:

* Patients who have used a proton pump inhibitor within 14 days prior to randomization, including over-the-counter omeprazole.
* Patients who have used any prescription or over-the-counter (OTC) treatment (other than proton pump inhibitors) for symptoms of GERD, such as histamine 2 receptor antagonists or prokinetics, within 72 hours prior to randomization.
* Patients with a known hypersensitivity, allergy, or intolerance to any component of esomeprazole or omeprazole.
Bougies as Aid for Endotracheal Intubation Via Video Laryngoscopy During Continuous Chest Compressions

The goal of this clinical trials is to analyze the effects of using bougies as adjuncts on the performance of endotracheal intubation via video laryngoscopy during cardiopulmonary resuscitation in anesthesia residents. The main question it aims to answer is whether bougie use has a significant effect on first-attempt failure of endotracheal intubation via video laryngoscopy during continuous chest compressions. Participants will perform endotracheal intubation via video laryngoscopy by four methods in a randomized order in a simulated cardiopulmonary resuscitation scenario on a manikin. The four methods are endotracheal intubations assisted by a railroaded bougie, assisted by a preloaded bougie, assisted by a stylet, and with no assistance. Researchers will compare the first-attempt failure rate of the four methods to see if a railroaded bougie method has a significant different first-attempt failure from that of the other three methods.


Eligibility Criteria:
Inclusion Criteria:

* Residents who are enrolled in the three-year standardized residency training program in the Department of Anesthesiology, Peking Union Medical College Hospital in February, 2023.

Exclusion Criteria:

* Residents who refuse to participate and residents who fail the pre-test.
Test-Retest Reliability, Responsiveness and Interpretability of CLEFT-Q

The goal of this observational study is to test the questionnaire CLEFT-Q in a population of patients with cleft lip and/or palate. The main questions it aims to answer are:

1. Are CLEFT-Q scores reliable over time?
2. Can CLEFT-Q detect change following surgical treatment intervention?
3. What is the norm for CLEFT-Q within a control population who do not have cleft lip and/or palate?
4. What is the Minimal Clinically Important Change of CLEFT-Q in different subpopulations of cleft lip and/or palate?
5. Do changes in CLEFT-Q scores correlate with changes in objective outcomes following a surgical intervention?
6. What are the main expectations that patients express before a surgical intervention?
7. How do patients perceive that the results after surgical interventions meet their expectations?
8. Do patients express concepts of importance postoperatively that are not examined by CLEFT-Q?
9. How do healthcare professionals perceive that the use of CLEFT-Q affects clinical decisions and processes?

Participants will

1. Fill out the questionnaire CLEFT-Q twice with a two-week space.
2. Before and 1 year after an operation.
3. Be interviewed about their experiences related to an operation or using CLEFT-Q.

Researchers will compare results from the cleft lip and palate population to see if there is a difference between them and a population without cleft lip and palate.


Eligibility Criteria:
Inclusion Criteria:

* Cleft lip and/or palate
* Planned secondary surgery of the nose, lips, jaw or to improve speech
* Can speak and read Swedish

Exclusion Criteria:

* Multiple surgeries at once
The Application of Different Sedation Protocols in ICU Patients With Severe Pneumonia

This study collected data from 600 patients with severe pneumonia to compare the duration of mechanical ventilation under different sedation regimens in real-world settings. It also evaluated and compared the sedation success rates, hemodynamic changes, and clinical outcomes of patients with severe pneumonia.

The study subjects were patients with severe pneumonia hospitalized in the Department of Respiratory and Critical Care Medicine at Xiangya Hospital, Central South University, from January 2024 to December 2024. Patients meeting all the following criteria were enrolled: (1) diagnosed with severe pneumonia; (2) receiving mechanical ventilation and requiring sedation treatment; (3) age ≥ 18 years. Patients were excluded if they met any of the following conditions: (1) allergic to routine sedative or analgesic medications; (2) had not undergone pain and sedation assessment; (3) transferred to another hospital during treatment; (4) abandoned treatment and were discharged within \<72 hours of treatment. Data on patient demographics, laboratory tests, chest imaging, respiratory support methods, severity of illness assessments, sedative medication usage, and clinical outcomes were collected. The duration of mechanical ventilation under different sedation regimens in real-world settings was compared, and the correlation between sedation success rates, hemodynamic changes, and clinical outcomes in patients with severe pneumonia was evaluated and compared.

Eligibility Criteria:
Inclusion Criteria:

(1)From February 1, 2023, to March 30, 2024, diagnosed with severe pneumonia in the Respiratory Intensive Care Unit of Xiangya Hospital, Central South University. The diagnosis of severe pneumonia is based on meeting at least one major criterion or three or more minor criteria:

1. Major criteria:

   ①Infectious shock requiring vasopressor therapy despite adequate fluid resuscitation;②Respiratory failure requiring tracheal intubation or mechanical ventilation.
2. Minor criteria:

   * Respiratory rate ≥ 30 breaths/min; ②Oxygenation index (PaO2/FiO2) ≤ 250;

     * Involvement of multiple lobes; ④Altered mental status and/or disorientation; ⑤Blood urea nitrogen ≥ 20 mg/dl (7.14 mmol/L); ⑥Systolic blood pressure \< 90 mmHg requiring aggressive fluid resuscitation. (2)Patients receiving mechanical ventilation who require sedation treatment. (3)Age ≥ 18 years.

Exclusion Criteria:

1. Allergic to routine sedative or analgesic medications.
2. Patients who have not undergone pain and sedation assessment.
3. Patients transferred to another hospital during treatment.
4. Patients who abandon treatment and are discharged within less than 72 hours of treatment.
The Clinical Utility of Measuring the Circadian Clock in Treatment of Delayed Sleep-Wake Phase Disorder

This study will test whether measuring the circadian clock during treatment of delayed sleep-wake phase disorder results in greater improvements in sleep compared to estimating the circadian clock.

The study is a randomized, controlled, parallel double-blind 4-week trial of 0.5 mgs of exogenous melatonin timed to either 3 h before actual dim light melatonin onset (DLMO) based on in-home measurement (M-DLMO, n = 25) or 3 h before DLMO estimated at 2 h before average sleep onset time based on actigraphy and sleep diary (E-DLMO, n = 25) in adult participants with delayed sleep-wake phase disorder. All participants will receive melatonin 0.5 mgs. Outcomes include change in DLMO, subjective and objective sleep parameters, and daytime symptoms.

As of January 7, 2020, the Insomnia Severity Index was removed from the IRB-approved protocol. No data were collected for this measure.

Eligibility Criteria:
Inclusion Criteria:

* Meet diagnostic criteria for delayed sleep wake phase disorder
* Female participants of childbearing potential must agree to use a reliable method of contraception from the screening visit until 4 weeks after the study has completed.

Exclusion Criteria:

* Hypersensitivity to melatonin or any other component of the product
* Sleep disorder other than delayed sleep wake phase disorder
* Medical and psychiatric conditions that may influence sleep or be affected by melatonin
* Current use of medications which may have interactions with melatonin
* Pregnancy or breastfeeding
* Routine night shift work
* Past month travel or planned travel during the study across more than one time zone
* Use of melatonin in the past month
* Current use of medications that may interfere with the measurement of melatonin
Psychiatric Disorders in Children With Psychogenic Cough

The study aims to evaluate psychiatric disorders and clinical features of children with psychogenic cough. Psychiatric disorders are assessed via a semi-structured interview (Kiddie Schedule for Affective Disorders and Schizophrenia) and clinical features are investigated via sociodemographic form, which was developped by researchers. Investigator planned to compare psychiatric diagnoses, specifically anxiety and depression, with children referred to pediatric clinics.


Eligibility Criteria:
Inclusion Criteria:

* Having psychogenic cough for study group.
* Referred to pediatric clinics.

Exclusion Criteria:

* Chronical psychiatric disorder and pediatric disease history for control group.
Extra Virgin Olive Oil, Red Wine Polyphenols and Fecal Microbiota

In this study, the investigators will evaluate the prebiotic effect of a moderate intake of extra virgin olive oil or red wine on the modulation of gut microbiota composition and the improvement of cardiometabolic factors in obese and lean adults subjects.


Eligibility Criteria:
Inclusion Criteria:

* Obese patients (body mass index (BMI= or \> 30kg/m2) with high insulin resistance (measured by Homeostasis Model Assessment Insulin Resistance Index (HOMA-IR) \> 5.5.
* Lean subjects (BMI\< 28kg/m2) with low insulin resistance (HOMA-IR\< 3.3).

Exclusion Criteria (all patients):

* Type 2 diabetes
* Acute or chronic infection
* Inflammatory disease or endocrine disorders.
* History of cancer.
* Anti-inflammatory, corticosteroid, hormone, or antibiotic drug treatment
* A history of alcohol abuse or drug dependence
* A restrictive diet or a weight change ≥5 kg during the 3 months prior to the study.
* Intake of prebiotics, probiotics, vitamin supplements or any other medical treatment influencing intestinal microbiota during the 3 months before the start of the study or during the study.
Phase II Study of Oxaliplatin and Navelbine for Second-Line Treatment of Advanced NSCLC.

The purpose of this study is to determine the response rate to treatment with oxaliplatin and Navelbine in patients with previously treated NSCLC. Oxaliplatin and Navelbine have not been clinically evaluated yet. However, Navelbine has been safely administered with other platinum compounds.

This is a non-randomized trial for patients with previously treated Non-small cell lung cancer. Each patient will receive 6 cycles of chemotherapy consisting of Oxaliplatin and Navelbine. Oxaliplatin is given intravenously every 21 days and Navelbine is administered Intravenously on day 1 and day 8 every 21 days.

Eligibility Criteria:
Inclusion Criteria:

* Locally advanced or metastatic non-small cell lung cancer that has recurred, progressed, or failed to respond to previous systemic chemo.
* Measurable disease
* Good performance status (ECOG 0,1 or 2)

Exclusion Criteria:

* Previously treated with Oxaliplatin or Navelbine
* Symptomatic CNS metastases
Prophylactic Antibiotics on Urethral Catheter Withdrawal

Urinary-tract infection (UTI) is the most common type of hospital-acquired infection (30% of all). The purpose of this study is to determine whether antibiotic prophylaxis for urinary catheter removal is useful at preventing catheter-associated urinary-tract infection.

Urinary-tract infection (UTI) is the most common type of hospital-acquired infection (30% of all). The researchers undertake a double-blind, placebo-controlled trial to assess the efficacy of single-dose therapy of trimethoprim-sulfamethoxazole or ciprofloxacin, versus placebo therapy in selected groups of surgical patients who had bladder drainage scheduled to last longer than 3 days.

Eligibility Criteria:
Inclusion Criteria:

* Urethral catheter in situ for at least 3 days (72h)

Exclusion Criteria:

* Pregnancy
* Impaired renal or hepatic function (serum creatinine \> 150 mmol/l, serum transaminases \> 75 IU/l)
* Fever
* Symptomatic urinary tract infection
* Antibiotic use ≤ 48 hours before urinary catheter removal
* Allergy to trimethoprim-sulfamethoxazole or ciprofloxacin
* Urologic pathology