cyrilzakka/clinical-trials huggingface dataset:
Performance, Efficacy and Safety of Vibrating Capsule in Aiding Constipated Individuals

This is a study intended to evaluate the efficacy and safety of the vibrating capsule versus sham non-vibrating capsule on spontaneous bowel movement, in aiding reliving Constipated Individuals


Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 18 years and older.
2. Patients with chronic idiopathic constipation according to Rome III criteria and who have not experienced relief of their symptoms from available therapies (osmotic and stimulant laxatives which was used for at least one month at recommended dose).
3. Patients with more than 1 bowel movement/2 weeks and \< 3 bowel movement/week.
4. Colonoscopy performed in the past 10 years prior to study participation, unless the patients are \<50 years old and without alarming signs and symptoms
5. Patient signed ICF
6. For women with childbearing potential, adequate contraception

Exclusion Criteria:

1. History of complicated/obstructive diverticular disease
2. History of intestinal or colonic obstruction.
3. History of significant GI disorder.
4. Use of following medication: Medication that may affect the bowel mobility, Prokinetics, Anti-Depressants, medications for treatment of Parkinson disease, Opiates, Calcium-channel Blockers, Aluminium/Magnesium Hydroxids
5. Clinical evidence of significant respiratory, CVS, renal, hepatic, biliary, endocrine, psychiatric, neurologic, or presence of abdominal pacemakers.
6. Presence of pacemaker.
7. History of, or current eating disorders, such as anorexia, bulimia, or compulsory overeating.
8. Diagnosis of mega-rectum or colon, a history of intestinal obstruction, congenital anorectal malformation, clinically significant rectocele, or any evidence of intestinal structural abnormality, including GI resection that affects bowel transit, or any evidence of intestinal carcinoma or inflammatory bowel disease of alarm symptoms such as weight loss, rectal bleeding, or anaemia.
9. History of Zenker's diverticulum, dysphagia or a known esophageal stricture 10. Chronic use of non-steroidal anti-inflammatory drugs (NSAIDs)

11. Participation in another clinical study in the last 4 months prior to screening.

12. Any other condition which in the opinion of the investigator may adversely affect the safety of the patient or would limit the patient's ability to complete the clinical study.

13. Women who are pregnant or lactating.

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Efficacy of Physical Exercise in Cardiac Rehabilitation

Physical rehabilitation is a key element in the treatment of patients with cardiovascular diseases, and recent evidence has shown that supervised exercise programmes can prevent cardiovascular events, improve physical function and quality of life. Individualized exercise prescription based on appropriate frequency, intensity and duration is recommended. Furthermore, recent studies have shown that physical cardiac exercise training can influence inflammation of the vessel wall and hence reduce development of arteriosclerosis in coronary vessels. In the literature are divergent conclusions on appropriate frequency and duration of physical rehabilitation programs in order to improve physical function and reduce arteriosclerosis.

The purpose of this study is to investigate the efficacy of an optimized physical rehabilitation programme compared to a conventional programme on physical fitness, health related quality of life and vascular inflammation.

Both trial groups carry out physical exercise training in groups. The exercise training is instructed by two physiotherapists with expertise in cardiac rehabilitation. Each training session takes 60 minutes and is based on current evidence for physical training for IHD and CHF patients. Exercise intensity progresses within the first week of the training program from moderate intensity (40-59% of VO2max), to high intensity (60-84% of VO2max). Exercise intensity of the individual training sessions is monitored by heart rate.

The training program includes the following:

Warm-up and stretching: Each training sessions starts 10 min. warm-up and ends with 5 min. stretching.

Aerobic exercise : Takes place on treadmill, stairs, ergometer bikes and interval training with different strength-endurance exercises.

Muscle strength: Is performed on machines with weight training equipment or by floor exercises. 10-15 repetitions are performed with a load equivalent to 50-60% of 1 RM.

The exercise programs for both groups are performed using a standardized exercise protocol.

All patients per a sub-maximal and a maximal exercise test prior to participation in the physical exercise training program.

Eligibility Criteria:
Inclusion Criteria:

Patients prescribed to physical exercise training at Skejby University Hospital with:

* stable and unstable angina pectoris,
* acute myocardial infarction with and without ECG changes
* chronic heart failure

Exclusion Criteria:

* patients with BMI\>35
* patients with musculoskeletal or neurological diseases that unable them to participate in physical exercise training programmes
* patients who can not read or understand danish language
Test-retest Reliability of a Standard Protocol on the Biodex Dynamometer

The purpose of the present study is to evaluate test-retest reliability of a standard protocol on the Biodex dynamometer in older adults.

In addition, the test-retest reliability and validity of an experimental measure of knee extension strength will be assessed in older adults.


Eligibility Criteria:
Inclusion Criteria:

* +65 years old
* able to perform a maximal strength test on a dynamometer

Exclusion Criteria:

* pathologies that prohibit a maximal strength test on a dynamometer
Lumbar Fusion Compared With Conservative Treatment in Patients With Chronic Low Back Pain: a Meta-analysis

* To determine the effect size of lumbar fusion measured by Oswestry Disability Index and compared with conservative treatment in patients with chronic low back pain.
* Meta-analysis using fixed effect model synthesis method.
* Included studies were retrieved from Medline and Cochrane CENTRAL databases since 1990.


Eligibility Criteria:
Inclusion Criteria:

* controlled randomized or non-randomized studies

Exclusion Criteria:

* not specified
Correlation Between CPAP Compliance and Food Intake Timing

Despite widespread agreement that continuous positive airway pressure is effective therapy for obstructive sleep apnea, it is estimated that 50% of patients recommended for therapy are noncompliant 1 year later. Nasal continuous positive airway pressure (CPAP) is the most definitive medical therapy for obstructive sleep apnea (OSA). Many patients have difficulty tolerating nasal CPAP due to nasal airway problems, mouth leak, and general discomfort from the mask and headgear. Interventions to improve compliance in such patients have not been studied. The investigators plan to further evaluate the usage of CPAP and identify if the timing of last meal before bedtime affects the compliance and tolerance of CPAP.

OSA is a chronic disorder characterized by frequent reduction and/or cessation of inspiratory airflow during sleep, with resulting hypoxemia and hypercapnia that are terminated by arousals. This pattern of repetitive arousals and nocturnal hypoxemia leads to disruption of sleep architecture and daytime hyper-somnolence as well as a multitude of neurobehavioral and cardiopulmonary derangements. All patients diagnosed with OSA should be instructed to undergo behavioral changes such as weight loss, avoidance of alcohol and sedatives, sleeping on the side and improvement in sleep hygiene, such as keeping a regular sleep schedule and getting an adequate amount of sleep. Continuous Positive Airways Pressure (CPAP) is currently considered to be the cornerstone of therapy for sleep apnea (OSA). However compliance with this treatment is frequently poor, which may lead to ongoing symptoms of sleep disruption, daytime sleepiness and poor waking cognitive function. Mechanical and psychological/educational interventions have been proposed to try to increase the hours of use of CPAP therapy. In older male patients with OSA, compliance with CPAP therapy is associated with attendance at a patient CPAP education and support group. Resolution of symptoms with therapy also appears to be associated with enhanced compliance. Some studies suggest that there is no direct causal relationship between OSA and gastro esophageal reflux disease (GERD). The investigators hypothesize that the compliance and tolerance to CPAP is affected with the timing of last meal before bedtime and this may also affect the symptoms of GERD.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with Obstructive Sleep Apnea.
* Patients on CPAP therapy
* Patients older than 21 years

Exclusion Criteria:

-Patients not on CPAP therapy
Effect of Inhalatory Sedation in Subarachnoid Hemorrhage

The aim of this study is to evaluate the effect of inhalational sedation on cerebral perfusion in patients with SAH.

It will evaluate whether the administration of isofluorane, by inducing direct vasodilation in the cerebral parenchyma, can improve the cerebral perfusion rates.

Perfusional CT will be used to study the variation of cerebral blood flow to rule out the vasodilatory effect on territories with different cerebrovascular reactivity aggravating the phenomena of distrectual hypoperfusion (theft theory).


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years old
* Diagnosis of non-traumatic SAH
* Neurological and/or systemic presentation that requires support of vital functions and sedation. This occurs for a WFNS score (World Federation of Neurosurgical Societies) ≥ 3.
* Possibility of ICP monitoring through EVD which is necessary in case of acute hydrocephalous. In case of the neurosurgeon do not indicate the positioning of the EVD, an intraparenchymal catheter will be positioned for the ICP monitoring.
* Patients with vasospasm (area of cerebral blood flow under 30% of the best value detected in the brain of the patients at the first CT scan). This exam will be performed at 2° - 3° day post event.
* Acceptance of informed consent.

Exclusion Criteria:

* Documented outcomes of cerebrovascular disease
* Patients with acute heart failure related to ESA
* State of pregnancy
* Patients with CLCR \< 30 mL/min
A Comparison of the Laryngeal Mask Airway (LMA) Proseal and LMA Supreme in Children

The aim of this randomized prospective study is to compare two laryngeal mask airways with a provision for evacuation of gastric contents, the LMA Proseal and The investigators hypothesize that airway leak pressures with the LMA Proseal will be significantly different (higher) when compared with the LMA Supreme.

The goal of this study is to compare the LMA Proseal and LMA Supreme in children having surgery. The investigators hypothesize that the airway leak pressures with the LMA Proseal will be superior to the LMA Supreme. Airway leak pressures will be measured by recording the circuit pressure at which equilibrium is reached. The ease of placement of the device and gastric tube, fiberoptic grade of laryngeal view, feasibility of use during positive pressure ventilation, and complications (airway related, gastric insufflation, trauma) will also be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Children undergoing general anesthesia using a supraglottic airway device
* weight 10-20 kg
* age 6 months-6 years

Exclusion Criteria:

* ASA class IV, V Emergency procedures
* History of a difficult airway
* Active gastrointestinal reflux
* Active upper respiratory tract infection
Occult Obscure Gastrointestinal Bleeding

To test the activity of a polyglucosamine (PG) together with a Standard Management protocol (SM) on the occult and obscure gastrointestinal bleeding (OGIB) and the clinical symptoms in patients suffering from colonic diverticulitis (CD).

The trial was conducted in a single center and subjects were participating to the San Valentino Vascular Screening Project (SVVSP). Sixty patients with history of colonic diverticulitis (CD) and occult obscure gastrointestinal bleeding (OGIB) were recruited. All subjects were following a Standard Management (SM) protocol consisting of diet and lifestyle modifications, and were freely choosing to be treated with polyglucosamine (PG) or to follow the SM only. Two groups of 30 cases each were formed and followed for 3 months.

Diet was controlled three times (baseline and during the first and third month), through the Food Intake Assessment (FIA) which consisted of the weekly analysis of 25 different servings (e,g fruits, vegetables, pulses, first dish, meat, processed meat, cheese). The lifestyle modification consisted of physical exercise (9 MET (Metabolic Equivalents) -h/week of brisk walking) and oral hygiene.

The main variable was OGIB, that was measured using Hemoccult Sensa Fecal Occult Blood Procedure.

Ancillary variables where the hs-CRP (high sensitivity C Ractive Protein) and the daily gastrointestinal discomfort (GID) measured thorough a visual analogue scale (VAS) from 0 to 10.

All variables were taken at baseline, after one and three months with the exception of GID that was measured also after one week of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Subjects aged between 55 to 65 years (males and females).
* CD diagnosis.
* DICA (Diverticular Inflammation and Complication Assessment) class DICA 2 or DICA 3.
* OGIB positive to Hemoccult Sensa Fecal Occult Blood Procedure.

Exclusion Criteria:

* Subjects with Class DICA \> 3.
* Therapy with mesalazine antibiotics and probiotics.
* Cancer of any type (a part from benign polyposis),
* Alcoholism.
* Parkinsonism.
* Alzheimer's Disease.
* Severe depression.
* Drug addiction.
Adaptation of a Behavioral Activation Treatment to Treat Depression in Autistic Adults

The present study aims to adapt and evaluate the feasibility of the BeatIt behavioral activation intervention for people with intellectual disabilities and low mood to be implemented with autistic individuals, with and without intellectual disabilities.

The study has two specific aims:

1. Adapt BeatIt materials for use with autistic adults with and without Intellectual Disability (ID). Focus groups engaging key stakeholders will inform the adaptation of BeatIt for autistic adults (i.e., BeatIt-ASD). A stakeholder advisory team will provide input through the duration of the study.
2. Evaluate the feasibility, acceptability, and preliminary efficacy of BeatIt-ASD for autistic adults. This includes examining if the data demonstrate the feasibility and acceptability of the BeatIt-ASD program for autistic adults and provide preliminary evidence for behavioral change (i.e., increased engagement in meaningful activities and reduced depressive symptoms).

Data will demonstrate the feasibility and acceptability of the adapted BeatIt intervention for autistic adults and provide preliminary evidence for reduction of depression symptoms via regulation of routines and achievement of meaningful goals.

Eligibility Criteria:
Inclusion Criteria:

1. Have a confirmed diagnosis of Autism Spectrum Disorders (ASD)
2. Have a best estimate diagnosis of clinically significant depressive symptoms by the study team. This will be based on DSM-5 criteria or DM-ID (Diagnostic Manual - Intellectual Disability).
3. Have a support person willing to participate
4. Live in New Jersey or New York, or be within travel distance to Rutgers University
5. Half of participants will have a best estimate diagnosis of mild to moderate intellectual disability and half will not have intellectual disability. This will be based on participant cognitive assessment and self and/or supporter report of adaptive function during the Baseline visit.

Exclusion Criteria:

1. Are unable to speak and understand English fluently (because the instruments being investigated are currently only validated in English and the focus group and intervention will be delivered in English).
2. Are currently enrolled in another behavioral therapy or psychotherapy targeting depression. Participants will not be excluded if they are currently taking medication.
Cannabinoids for the Reduction of Inflammation and Sickle Cell Related Pain

A randomized, double blind, study of dronabinol as a palliative agent in the treatment of pain, inflammation, and other complications of sickle cell disease (SCD).

A randomized, double blind, study of dronabinol as a palliative agent in the treatment of pain, inflammation, and other complications of sickle cell disease (SCD).

Primary Objective: To determine whether dronabinol will improve pain and QOL in adults with SCD and chronic pain.

Secondary Objectives: To assess dronabinol's effect on markers of inflammation in patients with SCD compared to placebo.

To determine the safety and tolerability of dronabinol use in adults with SCD compared to placebo.

Eligibility Criteria:
* Age \>18 years
* Clinical diagnosis of SCD (HbSS, HbSC, HbSβ+; Thal, HbSβ0Thal, HbS variants)
* Baseline score of 60 or lower on the ASCQ-Me 7-day pain interference domain
* If on a SCD modifying therapy (hydroxyurea, regular blood transfusions, L-glutamine, voxelotor, crizanlizumab), on stable dose for at least 3 months
* If using opioids for pain at home, on stable dose for at least 3 months
* One urine toxicology negative for cannabinoids within 30 days of randomization
* No known intolerance to dronabinol, or marijuana
* No history of psychotic episode, psychosis, or active suicidality
* No contraindication to dronabinol with attention to potential side effects, concurrent medications/substances, and concurrent medical problems, as evaluated by a physician
* Willing to abstain from cannabis, medical and illicit, during study weeks 1 through 8
* Not pregnant or nursing
* If a woman capable of becoming pregnant, willing to use a medically accepted form of birth control for the duration of study participation. Accepted forms include oral contraception, medroxyprogesterone, contraceptive implants or patch, surgical sterilization, total abstinence.
* Able to consent for research
* No daily cannabis use
* No diagnosis of active substance use disorder
Determining Developmental and Clinical Markers Affecting Urinary Function of Children With Spinal Dysraphism

To identify developmental and clinical biomarkers that affect urinary incontinence at the ages of 5, 7, and 10 according to different neuro-urological clinical factors.

This retrospective observational cohort study aims to identify developmental and clinical biomarkers that affect urinary incontinence at the ages of 5, 7, and 10 according to the types of spinal dysraphism, conus medullaris location, and urodynamics test results.

Eligibility Criteria:
Inclusion Criteria:

- Those who received spinal dysraphism diagnosis (ICD Code: Q05.1-05.9) and have been following up and receiving treatments due to neurogenic bladder.

Exclusion Criteria:

- As the study is a retrospective study, there is no exclusion criteria.
Impact of Whole-body Vibration Training on Sarcopenic Elderly

Sarcopenia is defined as a phenomenon which the amount of muscle mass in elderly aged 60-70 years is about 20-30% lower than that of the young adults and middle-aged people due to muscle atrophy caused by aging and alteration in muscle itself in aged skeletal muscle. Whole body vibration(WBV) training can be a choice for hospitalized patients who cannot conduct high intensity resistance training.

This study is prospective study.

The goal of this study is

1. To investigate the effect of whole body vibration training using vibration platform with tilt table on muscle mass, muscle strength, physical performance in hospitalized older adults with sarcopenia.
2. To demonstrate whether whole body vibration training using vibration platform with tilt table can be useful in hospitalized older adults with sarcopenia who could not perform high intensity exercise.

Eligibility Criteria:
Inclusion Criteria:

* More than 70-year old people who admitted Seoul National University hospital, Bundang.
* Deconditioning subjects with diabetics, infections, chronic lung disease, etc. who cannot walk independently due to long-term hospital care.
* Subjects who had a mobility impairment.
* Subjects who can agree voluntarily.

Exclusion Criteria:

* Subjects who inserted implant due to trauma within 1\~2 months recently.
* Acute coronary syndrome.
* Uncontrolled hypertension.
* Subjects who took drugs which can affects neuromuscular system.
* Severely impaired cognition
* Subjects who cannot agree volun.tarily.
The Role of Vitamin D Supplementation on Pain in Women With Primary Dysmenorrhea and Hypovitaminosis D

The purpose of this study is to evaluate the effect of vitamin D supplementation on the pain score of primary dysmenorrhea. Our hypothesis is that by normalizing vitamin D level could help improve pain score of women who have primary dysmenorrhea.

This study is aimed to be conducted in randomised controlled trial, comparing between intervention group and placebo group. We include women with primary dysmenorrhea who also have low vitamin D level in this trial. Our primary outcome is to compare visual analog pain scale between intervention and placebo group after treatment. After randomised and allocated, these women will be given vitamin D 50,000 IU or placebo capsules orally weekly for 8 consecutive weeks. We monitor pain score daily from the cycle before the drugs started until complete 8-week course of the regimen mentioned. Also vitamin D levels will be monitored twice, one before treatment and the other after treatment.

Eligibility Criteria:
Inclusion Criteria:

* Primary dysmenorrhea
* Hypovitaminosis D

Exclusion Criteria:

* Using calcium, magnesium or phosphorus in the past 3 months
* Using hormonal contraception or IUD in the past 6 months
* No smoking or alcohol drinking
* Chronic underlying diseases
* Allergic to components in study drugs
Exploration of the VOLATOLOM in the Stable Severe COPD (Chronic Obstructive Pulmonary Disease)

This is a prospective interventional study to determine whether the profile of volatile organic compounds (VOCs) present in exhaled air (VOLATOLOM) is reproducible in stable severe COPD (Chronic Obstructive Pulmonary Disease) patients.

After being informed about the study, all patients giving written informed consent and meeting the eligibility criteria will undergo 4 visits spaced 4 to 6 weeks apart.

The first visit V1 will be about 45 minutes duration. The others ones (V2 to V4) will be about 30 minutes duration.

All sessions will be carried out in the Pneumology Department of the Foch Hospital, volatolomics platform (Exhalomics®).

Exhalation collection will be performed at each visit in order to perform the volatolom analysis.

Eligibility Criteria:
Inclusion Criteria:

1. Severe COPD (FEV ≤ 50% of theoretical values)

   * stable for at least two months,
   * treated for at least one year with one (or more successively) combination of at least two inhaled drugs: either a Long-Acting Beta2-Adrenergic bronchodilator (LABA) combined with a corticosteroid (CSI), or a LABA combined with a long-acting anti-cholinergic bronchodilator (LAMA), or a triple combination LABA/LAMA/CSI;
2. History of at least one severe COPD exacerbation (treated with antibiotics and / or oral corticosteroid therapy) in the two years preceding the study;
3. Ex-smokers (at least 6 months of withdrawal) or active daily smokers of more than 10 pack-years
4. Severe dyspnea at baseline (mMRC stage ≥ 2)
5. Aged 40-85 years inclusive
6. Fluency in French
7. A signed and dated written informed consent is obtained prior to participation
8. Affiliated to a health insurance plan

Exclusion Criteria:

1. Severe exacerbation in the 4 months preceding the study
2. Chronic inflammatory disease (rheumatic, etc.) treated with long-term systemic corticosteroid therapy,
3. Long-term oxygen therapy (exclusive ambulatory oxygen therapy is not a non-inclusion criterion)
4. Unstable cardiovascular pathology (right or left heart failure, coronary artery disease);
5. Cancer
6. Pregnant women;
7. Deprived of liberty or under guardianship.