cyrilzakka/clinical-trials huggingface dataset:
A Clinical Study for Developing Artificial Intelligence(AI)-Based Clustering Model for Personalized Medicine in Acute Respiratory Failure

We will prospectively collect clinical information to develop a clustering analysis model and confirm phenotype for patients with acute respiratory failure who admit to the intensive care unit and require oxygen supply beyond a high flow nasal cannula, and a control group without acute respiratory failure. and clinical characteristics and prognosis will be compared.


Eligibility Criteria:
# Inclusion Criteria:

- Acute Respiratory Failure group

Among patients admitted to the internal medicine intensive care unit at Samsung Seoul Hospital, if all of the following conditions are met:

1) Age 18 or older 2) Patients who require treatment with high flow nasal cannula (HFNC), non-invasive ventilation (NIV (BIPAP or CPAP)), or mechanical ventilation (MV) due to acute respiratory failure.

- control group For comparative analysis, among patients admitted to the internal medicine intensive care unit at Samsung Seoul Hospital who meet all of the following conditions, they are registered as a control group with the consent of the subjects and undergo the same research procedure.

1. Age 18 or older
2. Patients who do not require high flow nasal cannula (HFNC), non-invasive ventilation (NIV (BIPAP or CPAP)), or mechanical ventilation (MV) treatment

   * Exclusion Criteria:

If any of the following criteria applies, you will not be permitted to participate in this clinical trial.

1. Patients 48 hours after oxygen treatment (HFNC, NIV (BIPAP or CPAP), MV)
2. Patients transferred from another hospital
3. Patients with limitations in treatment
Effects of Time of Sleep Restriction in Obesity

The purpose of this study is to determine the effect of different time of sleep restriction on control of food intake and metabolism of obese and normal subjects.

The reduction of sleep time has now become a common habit, driven by the demands and opportunities of modern society. Some studies have suggested that sleep restriction would be an important factor in predisposing to obesity. However studies of sleep restriction in obese individuals have not yet been conducted. Still, the time of sleep restriction varies greatly between studies, making it difficult to compare results.

The investigators aim to recruit 20 young adults, 10 obese and 10 normal weight individuals. The study will be conducted as a randomized, crossover study with three conditions. Each participant will be subjected to reduction of the beginning of sleep (from 3-7h), reduction of the end of sleep (from 23-3h), and normal sleep (from 23-7h), in random order, for three consecutive nights.

In each condition, subjects will stay for 4 days in the laboratory. Three control meals will be offered. Visual analogue scales will be applied before and after each meal to assess hunger and appetite for different food categories. Blood samples will be collected hourly during 24 hours.

Eligibility Criteria:
Inclusion Criteria:

* obese (BMI\>30) and normal weight (BMI between 19 and 24,9)
* regular time of sleep between 6.5 and 8 hours

Exclusion Criteria:

* self-reported sleep problems (Pittsburgh Sleep Quality Index score \>5);
* Obstructive sleep apnea (AHI \> 5 in polysomnography)
* night work;
* variable sleep habits or habitual daytime naps;
* regular physical exercise (\>3 hours/week);
* excessive intake of alcohol (\>7 drinks/week);
* excessive intake of caffeine (\>300 mg/day);
* smoking;
* substance abuse;
* use of prescription medications or over-the-counter drugs affecting sleep or metabolism;
* chronic diseases (e.g. cancer, asthma, back pain, thyroid disease, heart disease, diabetes, etc.)
* history of neurological, medical or sleep disorders;
* trans-meridian travelling the last month;
* chronotype: extreme morning or extreme evening
* unable to comply with the protocol.
Endoscopic Placement of Metal Stents in Treating Patients With Cancer- Related Duodenal Obstruction

RATIONALE: The use of endoscopy to place metal stents in the duodenum is less invasive than surgery for treating cancer-related duodenal obstruction and may have fewer side effects and improve recovery.

PURPOSE: Phase I/II trial to study the effectiveness of endoscopic placement of metal stents in treating patients who have cancer-related obstruction of the duodenum.

OBJECTIVES:

* Determine the objective response and clinical outcome in patients with duodenal obstruction secondary to malignancy treated with enteral Wallstents.
* Evaluate the efficacy and safety of this treatment in these patients.
* Evaluate the quality of life of these patients after enteral Wallstent placement.

OUTLINE: Patients undergo enteral Wallstent placement through an endoscope under fluoroscopic guidance into the duodenum.

Quality of life is assessed at 48 hours and 6 months after procedure.

Patients are followed at 48 hours, 30 days, 6 months, and then yearly thereafter until death.

PROJECTED ACCRUAL: A total of 20 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Endoscopically confirmed localized tumor as the cause of duodenal obstruction

  * All primary tumor types are eligible
* No prior duodenal Wallstents
* Must have symptoms of gastrointestinal obstruction, including:

  * Inability to move bowels, absence of flatus, nausea/vomiting, abdominal pain, or diarrhea

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* ECOG 0-3

Life expectancy:

* Not specified

Hematopoietic:

* Platelet count greater than 50,000/mm\^3

Hepatic:

* INR no greater than 1.5 times upper limit of normal

Renal:

* Not specified

Cardiovascular:

* No cardiac condition

Other:

* Not pregnant or nursing
* Fertile patients must use effective contraception
* No significant active infection (e.g., pneumonia, peritonitis, or wound abscess) that would preclude endoscopy
* No other serious concurrent illness
* No uncontrolled metabolic disease (e.g., diabetes mellitus or hypothyroidism)
* No dementia, psychiatric disorder, or altered mental status that would preclude compliance
* History of other neoplastic disease allowed
* Veterans Administration patients are not eligible

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* Prior or concurrent chemotherapy allowed

Endocrine therapy:

* Not specified

Radiotherapy:

* Prior or concurrent radiotherapy allowed

Surgery:

* At least 3 weeks since prior surgery and recovered
Olanzapine Given in Combination With Zonisamide SR to Prevent Weight Gain in Schizophrenic Subjects

The purpose of this study is to determine if zonisamide SR will prevent weight gain in schizophrenic subjects who take olanzapine (Zyprexa)


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects,18-55 years of age
* Outpatients diagnosed with schizophrenia, schizoaffective disorder, or schizophreniform disorder
* Body mass index (BMI) between 22-35 kg/m2 (inclusive)
* Negative serum pregnancy test in women of child-bearing potential
* If women of child-bearing potential, must be non-lactating and agree to use an acceptable form of contraception, which in all cases, includes one type of barrier method, throughout the study period and for 30 days after discontinuation of study drug
* Subject requires a change in antipsychotic treatment and olanzapine is deemed by the Investigator to be a reasonable antipsychotic treatment choice
* No clinically significant abnormality on ECG
* No clinically significant laboratory abnormality
* Negative urine drug screen
* Must be considered reliable and possess a level of understanding that enables the subject to provide written informed consent and to comply with protocol procedures and schedule
* Must be able to read and understand English

Exclusion Criteria:

* Diagnosis of substance dependence within the 6 months prior to randomization
* diagnosis of substance abuse (except for nicotine and caffeine) within the 3 months prior to randomization
* Suicidal behavior or ideation within 3 months prior to randomization, or any current suicidal ideation or intent
* Presence of dementia or other organic brain syndrome
* Serious or unstable medical illnesses
* Known, uncorrected narrow-angle glaucoma
* Diagnosis of eating disorder as defined by DSM-IV within 6 months prior to randomization
* Require treatment with any typical or atypical antipsychotic in addition to olanzapine
Quality of Life and Sexual Function of Vaginal Operation in The Treatment Of Previous Cesarean Scar Defect

The aim of this study is to further demonstrate the safety , validity and quality of (sexual)life of vaginal operation for previous cesarean scar defect resection.

collect all the patients'clinical information,use two questionnaire (the HRQoL and FSFI)to estimate patients' general healthy and sexual function before surgery and postoperation in 1 month,3 months and 6 months

Eligibility Criteria:
Inclusion Criteria:

* preoperative diagnosed as PCSD
* hemodynamic stability

Exclusion Criteria:

* irregular menstrual cycle
* using IUD
* complicating other disease also causing vaginal bleeding,such as endometrial polyp,submucous myoma and functional uterine bleeding.
Adherence and Quality of Life of CPAP for Obstructive Sleep Apnea

A multicentre, randomized controlled trial (RCT) design.The control group followed the usual treatment, while the intervention group (PIMA) followed the treatment with an adapted and flexible care plan depending on socio-demographic, clinical and psychological variables. The treatment plan includes different channels (home, telephone, care center), a continuous evaluation, and the use of the motivational interview in each of the interventions with the patient. The main outcome was adherence. Secondary outcomes were quality of life, emotional state, activities, social relationships, perceived competence and motivation.

The aim of this trial was to determine adherence to CPAP and health- related outcomes in patients with OSA via a comprehensive and multidisciplinary program based on stratification and individualized care plans, including the motivational interview.

A multicentre, randomized controlled trial (RCT) design was used. The control group followed the usual treatment, while the intervention group (PIMA) followed the treatment with an adapted and flexible care plan depending on socio-demographic, clinical and psychological variables. The treatment plan includes different channels (home, telephone, care center), a continuous evaluation, and the use of the motivational interview in each of the interventions with the patient. The main outcome was adherence. Secondary outcomes were quality of life, emotional state, activities, social relationships, perceived competence and motivation.

Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years
* Diagnosis of OSA confirmed by sleep studies with polygraphy (PS) and / or polysomnography (PSG)

Exclusion Criteria:

* Subjects with obesity-related hypoventilation
* Severe COPD (chronic obstructive pulmonary disease)
* Cognitive disorders and those unable to understand the consent to participate
Cervical Ripening Before Endometrial Biopsy in Abnormal Uterine Bleeding Using Sublingual Misoprostol

Abnormal uterine bleeding is common in Thai women. Fractional curettage is an diagnostic procedure of this condition. Traditionally, fractional curettage is performed under local anesthesia such as paracervical nerve block or intravenous meperidine.

Cervical dilatation using "metal cervical dilator" is a common method prior to perform fractional curettage. However, complication from this procedure can be occurred frequently, for example, uterine perforation, false tract formation and laceration of cervix.

Misoprostol is a prostaglandin E1 analogue which is commonly used in obstetrics and gynecology. Misoprostol transforms cervical component causing cervical ripening. This is very helpful for transcervical procedure because cervical dilatation is usually omitted. It can be prescribed in many route and sublingual route is the most effectiveness. Moreover, WHO supports the use of misoprostol in obstetrics and gynecology practice.

The hypothesis of this study is that "Misoprostol 200 micrograms sublingually is effective for cervical ripening before performing fractional curettage in patients with abnormal uterine bleeding" Double blind randomised controlled trial was performed using 26 patients in each group.


Eligibility Criteria:
Inclusion Criteria:

* thai women at the age over 35 years old
* presenting with abnormal uterine bleeding and have a plan to perform fractional curettage

Exclusion Criteria:

* uterine anomalies
* pregnancy
* pelvic inflammatory disease
* uncontrolled medical or psychological conditions
* known cases of gynecological diseases such as gynecological malignancies, abnormal pap smear
* Prostaglandin allergy
* Contraindicate to prostaglandin: asthma, mitral valve stenosis, glaucoma, sickle cell anemia
Systematically Assessing Effects of Colored Light on Humans With a Multi-modal Approach (Substudy 3 of 7)

NOTE: This is the third of in total 7 sub-studies related to the Ethics Committee of the Canton of Bern Ref. No. KEK-BE 2016-00674. This sub-study includes 50 participants and 6 arms, in total 350 participants will be assessed in all 7 sub-studies.

General study information: This is a randomized, cross-over, quantitative study, which investigates physiological variables, mood, and affect of healthy participants in response to colored light exposure. The Participants take part in 5-8 arms and are exposed to colored light only, or are additionally asked to solve cognitive tasks during the colored light exposure. Primary aim is to measure the change in several physiological variables, mood, and affect during colored light exposure of 15 or 45 minutes. The risk for the participants is negligible and comparable to the risk during daily life.


Eligibility Criteria:
Inclusion Criteria:

* Normal color vision
* Right handed
* Written informed consent

Exclusion Criteria:

* Smoking
* Any kind of diagnosed sleep disorder or neurological or psychiatric disorder in the last 3 months
* Acute severe traumas
* Chronic diseases with the necessity for medication
* Use of recreational drugs
* Regular intake of medication that would affect the outcome measures
* Regular excessive alcohol use (\> 18 standard units / week)
* Transmeridian travel in the last month (crossed \> 1 time zone border)
* Night shift word during the last month
Perinatal Outcomes in Nutritionally Monitored Obese Pregnant Women

The aim of this prospective randomized study is the prevention of excessive weight gain in obese pregnant women. The study will compare perinatal outcomes of obese pregnant women treated in the traditional way to outcomes of nutritionally monitored obese pregnant women and evaluate a preliminary behavioral model applicable to the general practice of obstetrics.

Study Population and Selection:

This study will recruit 200 obese pregnant women at 12 to 28 weeks of gestation with a body mass index (BMI) of greater than 29.9 kg/m2. Women will be eligible if they are pregnant with a single fetus, and are free of diabetes, hypertension, or chronic kidney disease at recruitment.

Methodology:

The patients will be randomized to either traditional or monitored groups. All participants will be counseled at least once regarding conventional prenatal nutrition guidelines. A more detailed dietary intake protocol would be done with the intervention (monitored) group, which would include being placed on a balanced nutritional intake regimen of 18-24 kcal/kg/day (no less than 2000 calories). Each patient will be asked to record in a diary all of the foods she eats during the day, which will be reviewed by the investigator or assignee at each prenatal visit. The patients will be weighed at each prenatal visit with the monitored patients weighed and blinded to their actual weight.

Data analysis:

The two groups will be compared with respect to pregnancy weight gain, proportion of excessive weight gain (greater than 15 pounds), maternal morbidity, intrapartum complications and newborn birthweight. The primary analysis will consist of a two sample t-test comparing the monitored versus non-monitored groups with regard to weight gain at delivery. A secondary analysis using a repeated measures ANOVA will look at weight gain in the two groups from baseline to 6 weeks post partum in order to look at trends over time. Tests of mean contrasts will compare differences between the two groups at each time during and post pregnancy relative to baseline. Additional analyses will be done to look at other outcomes. In the case of continuous variable outcomes (e.g., gestational weight), a student's t-test will be used. while for categorical outcomes (e.g., macrosomia), the chi square test will be used for the comparison. Alpha will be 0.05 for each comparison.

Eligibility Criteria:
Inclusion Criteria:

* BMI greater than 29.9 kg/m2
* Single fetus

Exclusion Criteria:

* Diabetes
* Hypertension or chronic kidney disease
The Effect of Aerobic Exercises and Yoga Exercises in Axial Spondyloarthritis

Axial Spondyloarthritis (AxSpA), mainly affecting the axial skeleton and sacroiliac joints, is a chronic, systemic, inflammatory disease that causes structural and functional disorders. Exercise has a significant role to play in managing treatments. This study aimed to determine the effect of yoga-based exercises combined with aerobic exercise on spinal mobility, disease activity and aerobic capacity in AxSpA.

The study included 60 AxSpA patients according to ASAS criteria. Patients will be divided into two groups randomised. Group 1 (n=30) received only aerobic exercise, group 2 (n=30) received aerobic exercise and yoga exercises will be applied. Aerobic exercise intensity will be measured by cardiopulmonary exercise test (CPET). determined.

Aerobic exercises will be performed with a lower extremity ergometer for 30 minutes and 12 sessions. In group 2, in addition to aerobic exercises, spinal stretching, relaxation, respiration and meditation will be performed. A yoga-based exercise programme consisting of exercises will be applied for 40 minutes and 12 sessions.

Functional capacity before and after treatment, 6-min walk test (6MWT) and VO2 maximum and disease activity will be assessed by ASDAS-CRP. Clinical measurements Bath Ankylosing Spondylitis Functional Index (BASFI), Bath Ankylosing Spondylitis Metrology Index (BASMI), Ankylosing Spondylitis Quality of Life (ASQL) scale will be used. Fibromyalgia symptom severity scale and widespread pain index scores will be calculated.

Eligibility Criteria:
Inclusion Criteria:

Axial spondyloarthritis patients according to ASAS criteria having a stable health condition, having ongoing fatigue, dyspnea, decreased stamina, difficulty in activities of daily living, anxiety, or depression complaints

Exclusion Criteria:

* Hemodynamically unstable, cardiac and pulmonary system unstable, with neurological, and psychological disorders patients
Mental Practice Versus Proprioceptive Neuromuscular Facilitation on Strength of Upper Limb

The effects of mental practice combined with proprioceptive neuromuscular facilitation on muscle strength of upper limb were measured in 60 healthy students Subjects were randomly assigned to either proprioceptive neuromuscular facilitation (PNF) group or mental practice (MP) group. PNF group: 30 individuals, these subjects received only PNF training. MP: 30 individuals, these subjects received mental practice.

The effects of mental practice on muscle strength of upper limb were measured in 60 healthy female students with right dominant hand,. Their age ranged from17 to 23 years old. Subjects were randomly assigned to either proprioceptive neuromuscular facilitation (PNF) group or mental practice (MP) group. PNF group: 30 individuals, these subjects received only PNF training. MP: 30 individuals, these subjects received MP. training program has been administered for every group for 12 sessions over 4 weeks with 3 x 45 min training sessions per week. Pre-post test design was used. EMG device was used to measure the electrical activity of muscles. Measurements conducted at pre-intervention, during intervention and post-intervention testing with 20 days.

Eligibility Criteria:
Inclusion Criteria:

1.Absence of a prior injury of arm

Exclusion Criteria:

1.History of a neurological disease.
A Study to Look at How Insulin NNC0471-0119 Works in the Body in People With Type 1 Diabetes When Injected by Insulin Pump

This study is looking at the effect and safety of 3 formulations of the new rapid-acting insulin analogue NNC0471-0119, for the treatment of type 1 diabetes when given by insulin pump.

The study will test how 3 different formulations of insulin NNC0471-0119 are tolerated by the body, how they are transported in participants bloodstream, how long they stay there and how the blood sugar is lowered.

The 3 formulations of insulin NNC0471-0119 are given as one bolus on top of a constant insulin basal rate and compared to Faster Aspart (Fiasp®).

Participants will get 3 formulations of insulin NNC0471-0119 and Faster Aspart (Fiasp®) Insulin NNC0471-0119 is a new rapid-acting insulin designed to be used in an insulin pump. Faster Aspart (Fiasp®) is a globally used medication for the treatment of diabetes.

Participants will have each study medicine administered once via pump at separate study visits. This mean that participants will have a total of 4 dosing visits where participants will get a study medicine. Which study medicine participants get at what visit will be decided by chance.

The study will last 1-4 months. Participants will have 7 visits at the clinic, 4 of them will require an in-house stay of 3 consecutive days each.

During the in-house visits 2 intravenous (into the vein) cannulas will be inserted for blood sampling and infusions.

Women: Women cannot take part if they are of childbearing potential.


Eligibility Criteria:
Inclusion Criteria:

* Male participant or female participant of non-childbearing potential. Non-childbearing potential being defined as surgically sterilised (i.e. documented hysterectomy, bilateral salpingectomy or bilateral oophorectomy) or being postmenopausal (defined as no menses for 12 months without an alternative medical cause) prior to the day of screening.
* Aged 18-64 years (both inclusive) at the time of signing informed consent.
* Diagnosed with T1DM for more than1 year prior to the day of screening.
* Current total daily insulin treatment between 0.2 and 1.2 (I)U/kg/day (both inclusive).
* Treated with continuous subcutaneous insulin infusion greater than 90 days prior to the day of screening.

Exclusion Criteria:

* Known or suspected hypersensitivity to study interventions or related products.
* Participation (i.e., study intervention) in any interventional, clinical study within 30 days or 5 times the half-life of the drug, whichever is longest before screening.
Does a Safety Guidewire Increase the Forces Needed to Move the Ureteroscope up and Down the Ureter?

The purpose of this study is to investigate to forces needed to passage the ureteroscope up and down the ureter with and without a safety guidewire in place.

Ureteroscopy may damage the ureter, and the complication risk is influenced by the forces needed to move the ureteroscope up and down the ureter.

Although a safety guidewire (SGW) is commonly recommended in order to reduce the complication rate it may well be that the SGW itself may inhibit the passage of the ureteroscope due to increased friction.

The forces needed to move the ureteroscope in the ureter have not been investigated properly.

The intention in this study is to measure the forces needed to advance and withdraw the ureteroscope in the ureter with and without the SGW in place.

Eligibility Criteria:
Inclusion Criteria:

* Patients planned for endoscopic kidney stone treatment

Exclusion Criteria:

* Known pathology in the ureter