cyrilzakka/clinical-trials huggingface dataset:
Single-operator Versus Double-operator in Single-Balloon Enteroscopy

Compared with two-person in single-balloon enteroscopy, one-person single-balloon enteroscopy has the advantages of better observation and treatment of lesions, shorter examination time, saving resources in the endoscopy room, and reducing the postoperative discomfort of the examined person, etc. However, there is no comparative study of one-person and two-person in single-balloon enteroscopy.

The incidence rate of chronic small bowel disease in China is 6.14%. Due to the deep location, large length, tortuous shape and large free degree, the diagnosis and treatment of small bowel disease has always been a major challenge in the clinical work of gastroenterology. Although capsule endoscopy can realize the observation of the whole small intestinal mucosa, it cannot effectively observe in real time the suspicious lesions, much less treatment, and its many difficulties still need to be resolved. Enteroscopy allows for real-time, direct visualization of the small intestine and provide effective treatment, which is an important tool for the diagnosis and treatment of small intestinal diseases. The depth of small bowel insertion and whole small bowel examination rate are important indicators for evaluating enteroscopy. However, due to objective factors, such as lesion location and luminal stenosis, the depth of insertion is a better indicator of the quality of enteroscopy, which is more in line with clinical needs.Currently,the single-balloon enteroscopy, which is now more common in clinical practice, have been designed and optimized for relative ease of operation and a shorter learning curve.Compared with two-person in single-balloon enteroscopy, one-person single-balloon enteroscopy has the advantages of better observation and treatment of lesions, shorter examination time, saving resources in the endoscopy room, and reducing the postoperative discomfort of the examined person, etc. However, there is no comparative study of one-person and two-person in single-balloon enteroscopy.Therefore, we propose to conduct a multicenter, noninferiority, randomized controlled study to explore the effect of single and double operation on single balloon small bowel insertion depth, total small bowel examination rate, and lesion detection rate.

Eligibility Criteria:
Inclusion Criteria:

* age greater than eighteen years;
* Suspected small bowel disease with proposed enteroscopy

Exclusion Criteria:

* patients with a history of small bowel surgery;
* patients who fail to perform bowel preparation as required;
* patients at high risk for esophageal varices with risk of bleeding;
* patients who have not planned a deep small bowel examination before enteroscopy, such as a lesion clearly located in the duodenum, proximal jejunum or terminal ileum;
* patients who are in extremely poor physical condition and are not suitable for general anesthesia, as defined by an ASA score greater than 3;
* Pregnant or lactating women;
* Inability to provide written informed consent.
The Effect of Yoga on Respiratory Functions, Symptom Control and Life Quality of Asthma Patients

This study was conducted to find out the effect of yoga applied to asthma patients on the patients' respiratory functions, symptom control and quality of life.

While there are studies conducted with yoga on different patient groups in Turkey, no studies have been found on asthma patients specifically. For this reason, it was thought that studies are needed which will prove the effect of yoga practices in preventing and controlling symptoms of asthma patients and which will contribute to nursing literature.

Eligibility Criteria:
Inclusion Criteria:

* must be between 18 and 55 years old
* must be diagnosed with asthma at least for six months,
* must be living in the city centre,
* must be literate and volunteered to participated in the study, were included in the study

Exclusion Criteria:

* be participated in a regular exercise program in the last 6 months,
* be have another respiratory system disease
* be in the exacerbation period,
* have a physical disease or cognitive deficiency and a psychiatric disease diagnosis that could prevent understanding the training given,
MOWI Amulet Mobile Health Technology Validation

This study aims to adapt a mobile health device (Amulet) for use in older adults. It is the second in a series of four research studies whose overarching goal is to conduct a program of pilot research aimed at developing and evaluating a technology-assisted wellness intervention for older adults with obesity who may or may not live in a rural area.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-64; and Age≥65 years
* Body Mass Index (BMI) ≥ 30kg/m\^2 for those aged≥65 years
* Waist circumference ≥88cm in females or ≥102cm in male for those aged≥65 years

Exclusion Criteria for those aged ≥65 years:

* Severe mental or life-threatening illness
* Dementia
* Substance use
* History of bariatric surgery
* Suicidal ideation
* Unable to perform measures
* Reside in nursing home
Conservative Versus Operative Management in Adhesive Intestinal Obstruction

This study aims to evaluate the role of Conservative management in patients with adhesive Intestinal Obstruction Regarding the selection criteria of the patients, duration of conservative route, success rate, and recurrence of adhesions and avoiding the surgical route complications.

Adhesive Intestinal Obstruction is very common and represents a serious life threatening condition, which can be caused by congenital band, following abdominal surgeries and other medical conditions like tuberculosis.

The management options for adhesive intestinal obstruction (AIO) could be operative treatment (open-laparoscopy) or non-operative (conservative management) according to many reasons.

Some reports indicate that the operative management for adhesive Intestinal obstruction lead to further adhesions in the future in addition to other possible complications (anaesthetic - iatrogenic injury during adhesolysis - wound site infections - illius-long hospital stay).

The Conservative route is recommended in all patients except those with signs of peritonitis, strangulation, or bowel ischemia which would have been diagnosed during physical examination and imaging.

A few studies compared the advantages, safety, and less complications of Conservative versus operative management. Therefore, this study will be conducted on patients with adhesive Intestinal Obstruction to compare the effectiveness of Conservative versus operative management regarding the selection criteria for the patients, the duration of the Conservative route, things to be done and what need to be observed during the conversation time.

Eligibility Criteria:
Inclusion Criteria:

* Age 6-70 years.
* Both sexes.
* Complete \\ Partial adhesive Intestinal Obstruction, with CT Abdomen and pelvis with oral and IV Contrast.

Exclusion Criteria:

* Patients with signs of Strangulation
* Patients with signs of peritonitis.
* Patients with signs of bowel ischemia
* Failure of Conservative management for more than 72 hours.
* Vitally unstable patients
* Patients with comorbidities which need rapid interventions.
Oral Duloxetine as a Premedication for Postoperative Pain Control

The purpose of the study is to use duloxetine as premedication in Anterior cruciate ligament repair under spinal anesthesia and evaluate the effect on onset and duration of spinal anesthesia and postoperative pain control.

We designed this randomized, double-blind study to evaluate the effectiveness of administration of oral duloxetine 2 hours preoperatively on the onset and the duration of the spinal anesthesia in arthroscopic anterior cruciate ligament (ACL) repair and the role of duloxetine on postoperative analgesia.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists I or II.
* Sex: Both sexes.
* Age between 18 and 50.
* Height 155-180 cm.
* Patients scheduled for arthroscopic anterior cruciate ligament (ACL) repair under spinal anesthesia.

Exclusion Criteria:

* Declining to give written informed consent.
* History of allergy to the medications used in the study.
* Had a history of drug or alcohol abuse.
* Taking opioids or sedative medications.
* Inability to communicate with patients to evaluate the postoperative pain.
* Need for postoperative ICU hospitalization.
* Hepatic or renal failure.
* Patients with a history of taking duloxetine or any SSRIs.
* Contraindications to regional anesthesia (including coagulopathy and local infection).
* Psychiatric disorders with antipsycotics or antidepressants (tricylic or MAOIs).
* Antiplatelets (aspirin, clopidogrel) or anticoagulant (warfarin).
* Quinolones (ciprofloxacin).
Cohort Study Comparing Surgeon Stress, Utilization of Surgical Instruments, Surgical Outcomes According to Surgical Approach for Gastrectomy

A new surgical instrument is supposed to allow surgeon to do surgery with better performance. However, the learning period before getting used to the new instruments is necessary. The surgeon's stress to overcome the learning effect and the surgical outcome was rarely assessed. The comparative analysis of surgical outcome, surgeon's stress, and utilization of instruments for gastrectomy will be performed in prospective cohort study

Before the surgery, all the eligible patients will be explained regarding the study and informed consent will be given. During the surgery, the surgeon will wear heart rate monitoring device to monitor hear rate variability of the surgeon. The surgical procedure will be recorded. After the surgery, morbidity following surgery will be monitored and recorded. At 1 month after surgery, additional morbidity will be recorded.

Eligibility Criteria:
Inclusion Criteria:

Patients with gastric cancer scheduled for gastrectomy

Exclusion Criteria:

Vulnerable subject (illiterate, pregnant)
An Open-Label Extension for the Phase 2 Study in Early Symptomatic Amyotrophic Lateral Sclerosis Patients on Stable Background Therapy to Assess Bioenergetic Catalysis With CNM-Au8 to Slow Disease Progression in ALS

This is an optional open-label extension to participants that have completed the clinical trial CNMAu8.205.

A forty-eight (48) week optional open-label extension period (Open- Label Period), which may be extended by 12-week increments until discontinued by the Sponsor for participants that have completed protocol CNMAu8.205.

Eligibility Criteria:
Inclusion Criteria:

1. Participants must have completed the randomized placebo-controlled Treatment Period without compliance issues.
2. Able to understand and give written informed consent to participate in the open-label extension.
3. If referred from a third party (neurologist or a State based ALS organisation), participant agrees to maintain transfer of care to a neurologist participating in the study.

Exclusion Criteria:

1. Lack of treatment compliance during the randomized placebo controlled Treatment Period.
2. Positive pregnancy test at the Week 36 visit, or, females who plan to get pregnant during the course of this extension or within 6 months of the end of this extension.
3. Based on the investigator's judgment, patients who may have difficulty complying with the protocol and/or any study procedures.
4. Patient with clinically significant abnormalities in haematology, blood chemistry, ECG, or physical examination identified during the W36 visit which according to Investigator may interfere with continued participation.
5. Patients with clinically significant hepatic or renal dysfunction or clinical laboratory findings that would limit the interpretability of change in liver or kidney function, or those with low platelet counts (\< 150 x 10\^9 per liter) or eosinophilia (absolute eosinophil count of ≥ 500 eosinophils per microliter) at the Week 36 visit.
6. Patient is considered a suicide risk in the opinion of the Investigator, has previously made a suicide attempt, or is currently demonstrating active suicidal ideation. Subjects with intermittent passive suicidal ideation are not necessarily excluded based on the assessment of the Investigator.
Measles Vaccine in HCW

Till now, mortality reports among children below 9 years remains extremely low despite that the incidence of death toll is high and exceeding 50,000 patients among older population, One speculation for lower SARS infectivity is that cross-protective antibodies against measles vaccine ( MV). In mice susceptible to measles virus, recombinant MV induced the highest titers of neutralizing antibodies and fully protected immunized animals from intranasal infectious challenge with SARS-CoV,

The primary objective of the present study is to determine the benefit of measles vaccine in health care professional to decrease the incidence of COVID-19.

We Hypothesized that, measles vaccine may lower the incidence of serologically proven SARS-CoV-2 infection and reported respiratory illness


Eligibility Criteria:
Inclusion Criteria:

* Age 18-50 years old
* Subjects who are willing to comply with the requirements of the study protocol and scheduled visits (for example, completion of the subject diary, return for follow-up visits) and who are willing to make themselves available for the duration of the study with access to a consistent means of telephone contact

Exclusion Criteria:

* acute severe illness
* recent receipt of a blood product
* history of thrombocytopenia
* Pregnant females
* any chronic medical condition
* Any participant receiving any immune suppressive medication
* Immunocompromised staff
* Participants who have egg allergy
* Participants who care for immune compromised hosts
* Participants who test positive for COVID-19 serology prior to randomization
Impact of CO2 on Cerebral Blood Flow in Infants Less Than 6 Months During General Anaesthesia

The study aims at assessing cerebral blood flow variations following expired CO2 variations in anaesthetized infants less than 6 months, during a routine general anesthesia.

The study aims at assessing cerebral blood flow (measured with Near-Infrared Reflectance Spectroscopy - NIRS - and transcranial Doppler - DTC) variations following end-tidal expired CO2 variations in anaesthetized infants less than 6 months, during a routine general anesthesia performed according to standards of care.

Eligibility Criteria:
Inclusion Criteria:

* Age \< or = 6 months
* ASA class \< or = 3
* General anesthesia required for surgery

Exclusion Criteria:

* No parental consent
* Emergency surgery
* Preexisting neurological condition
* Hemodynamic instability
* Preexisting hypoxemia and/or hypercapnia
* Laparoscopy or thoracoscopy, if expected EtCO2 level achieving would require unsafe ventilation parameters
The Effect of Strawberries in a Cholesterol-Lowering Dietary Portfolio

The purpose of this study is to determine whether addition of strawberries to a dietary portfolio of cholesterol-lowering foods will improve compliance and so increase the effectiveness of the dietary portfolio in lowering cholesterol and improving cardiovascular risk factors.

We have shown in 1-month metabolic studies that the dietary portfolio can lower cholesterol to the same extent as first generation statins (cholesterol-lowering drugs). In the on-going long-term 'real world' study using this dietary portfolio, only one-third of participants were able to achieve similar cholesterol reductions at the end of 1 year. Varying compliance has been identified as the main issue why the other two-thirds could not achieve a similar level of reduction. We believe the addition of strawberries to this diet, by virtue of their beneficial components (fibre and antioxidants)and by replacement of less desirable foods (fatty deserts), may further improve the CHD risk profile of a very effective cholesterol reduction strategy.

Method:

454 g of strawberries per 2000 kcal per day will be provided for a one-month period to approximately 40-50 subjects on a long-term dietary portfolio study, all of whom have been on the diet for at least 6 months to 1 year. The active dietary components consist of viscous vibers (including oat bran), soy products (including soy milk), almonds and plant sterols (sterol enriched margarine). Strawberry recipes will be used to enhance compliance of these components. Subjects will undergo the study in a randomized crossover design where the control will be the dietary portfolio with additional 65 g oatbran bread (without psyllium) replacing the strawberries.

Bloods will be taken at weeks 0, 2 and 4 of each treatment period; and at one month prior to and after the 8-week study while on the long-term dietary portfolio.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult men and postmenopausal women currently enrolled in the long-term dietary portfolio study
* Body mass index \<32 kg/m2
* constant body weight over last 6 months preceding the onset of the study
* Fasting LDL cholesterol concentration\>4.1 mmol/L at diagnosis

Exclusion Criteria:

* women of child-bearing potential
* major cardiovascular event (stroke or myocardial infarction)
* positive molecular diagnosis of familial hypercholesterolemia
* secondary causes of hypercholesterolemia (hypothyroidism, unless treated \& on a stable dose of L-thyroxine, renal or liver disease)
* use of cholesterol-lowering medications
* serum triglycerides \>4.5 mmmol/L
* blood pressure \> 145/90 mmHg
* diabetes and or major disorders such as liver disease, renal failure or cancer
* major surgery \<6 months prior to randomization
* alcohol consumption \> 2 drinks per day
A Study to Evaluate the Efficacy and Safety of Pegozafermin in Participants With Compensated Cirrhosis Due to MASH

The study will assess the efficacy and safety of pegozafermin administered in participants with compensated cirrhosis due to MASH (biopsy-confirmed fibrosis stage F4 MASH \[previously known as nonalcoholic steatohepatitis, NASH\]).


Eligibility Criteria:
Key Inclusion Criteria:

* Males or non-pregnant females aged between 18 and 75 years (inclusive) at time of signing the informed consent form (ICF).
* At least 1 metabolic risk factor.
* Biopsy-confirmed fibrosis stage F4 MASH (per non-alcoholic steatohepatitis \[NASH\] Clinical Research Network (CRN) system) with compensated cirrhosis.
* Body mass index (BMI) at screening ≥25.0 (≥23.0 for Asian participants) and \<50.0 kilograms (kg)/meters squared (m\^2).

Key Exclusion Criteria:

* Liver disorder other than MASH.
* History or evidence of hepatic decompensation.
* History or evidence of hepatocellular carcinoma.
* Have type 1 diabetes mellitus or poorly controlled type 2 diabetes mellitus.
* ALT or aspartate aminotransferase (AST) ≥250 units per liter (U/L).
* Participants taking vitamin E (\>400 international units \[IU\]/day) must be on stable dose for at least 6 months prior to screening.

Other inclusion and exclusion criteria may apply.
A Study to Evaluate Safety and Efficacy of Telotristat Etiprate (LX1606) in Participants With Acute, Mild to Moderate Ulcerative Colitis

This is a multicenter, placebo-controlled, parallel-group, pilot study to evaluate safety and preliminary effectiveness of two blinded dose levels of telotristat etiprate (LX1606) in participants with acute, mild to moderate ulcerative colitis on 5-aminosalicylic acid/mesalamine therapy.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of ulcerative colitis of at least 6 months duration
* Disease extends at least 15 cm proximally from the anal verge, documented within the past 3 years
* Flare occurs on 5-aminosalicylic acid (5-ASA)/mesalamine therapy and subject is willing to remain on a stable dose for the duration of the study
* Age ≥18 and \<70 years of age
* Able and willing to provide written informed consent

Exclusion Criteria:

* Prior terminal ileum or colonic surgery, except appendectomy or hemorrhoid surgery
* Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or clinical findings suggestive of Crohn's disease
* Clinical signs of fulminant colitis or toxic megacolon
* History of dysplasia associated lesion or mass (DALM)
* Subjects who have had surgery for ulcerative colitis, or in the opinion of the investigator, are likely to require surgery for ulcerative colitis during the study
* History of primary sclerosing cholangitis
* Any physical or laboratory abnormality deemed by the investigator as clinically significant
* Major surgery within 60 days of Screening
* Use of any investigational agent within 30 days of Screening or any therapeutic protein or antibody within 90 days of Screening
Early Detection of Myocardial Work Impairment in Obesity II(EARLY-MYO-OBESITY-II)

This prospective study intends to explore the change of cardiac structure and function in the cohort of overweight or obesity patients, and determine the impact of clinical characteristics on cardiac remodeling and mechanics.

Obesity significantly increases the risk for heart failure. Early detection of preclinical cardiac dysfunction in overweight or obesity and understanding its association with insulin resistance are of great importance.Recently, a novel technique for myocardial work (MW) assessment has been introduced to evaluate myocardial performance. To date, change of MW has been described in several cardiac conditions including dilated cardiomyopathy, significant coronary arterial diseases, and hypertrophic cardiomyopathy, which implies regional or global myocardial dysfunction. In this study, we aimed to explore the alteration of MW in overweight or obese adults and to determine whether insulin resistance or other clinical risk factors may impact myocardial mechanics before impairment of systolic function.

Eligibility Criteria:
Inclusion Criteria:

* All patients were older than 18 without any cardiac symptoms.
* The diagnosis of overweight was established when body mass index (BMI) of 25 to 30 kg/m2.
* Obese was defined as a BMI of 30 kg/m2 or higher.

Exclusion Criteria:

* diagnosis of type 2-Diabetes Mellitus according to the American Diabetes Association criteria;
* left ventricular ejection fraction\<50% on echocardiography;
* arrythmia on electrocardiogram;
* severe valvular stenosis or regurgitation;
* history of coronary disease (defined as stenosis\>50%) or myocardial infarction;
* stress induced wall motion abnormality on echocardiography, coronary artery stenosis \>50% on coronary CT or angiography with Framingham risk score of \>10;
* pacemaker or defibrillator implantation;
* the presence of bundle branch block;
* severe infection or renal dysfunction with an estimated glomerular filtration rate \< 60 ml/min/1.73 m2);
* inadequate image quality on echocardiography.
Diagnostic Accuracy of Optimized Diffusion-Weighted Imaging for Detecting Anterior Ischemic Optic Neuropathy

The patient presents to the ophthalmological emergencies and / or to the internal medicine department. NOIA clinical discovery Patient referred in radiology for brain and visual MRI. The two sequences added by the research (8 minutes) will be added to that of the treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years old
* Patient with suspected NOIA, evoked after clinical examination by a specialized ophthalmologist
* For which a brain and visual MRI is planned
* Express consent to participate in the study
* Affiliate or beneficiary of a Social Security scheme

Exclusion Criteria:

* Contraindication to MRI (electrical device, metallic foreign body, claustrophobia)
* Patient benefiting from a legal protection measure
* Pregnant or breastfeeding woman