cyrilzakka/clinical-trials huggingface dataset:
Effect of Mosapride on Gut Transit in Patients With Chronic Constipation or Constipated Irritable Bowel Syndrome and Healthy Subjects

Effect of mosapride 30mg/day on the small bowel and colon transit time in patients with chronic constipation or constipated irritable bowel syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Functional constipation or constipated irritable bowel syndrome patients according to Rome III criteria

Exclusion Criteria:

* Intolerable or hypersensitive to mosapride
* Known Parkinson's ds
* Cardio- or cerebrovascular disease within 3 months
* Malignancy requiring surgery or chemotherapy or radiation within 5 years
* History of GI surgeries except hernia repair, appendectomy, primary closure due to perforation
* Refractory diabetes mellitus/hypertension/thyroid diseases
* Symptomatic heart failure, renal failure, arrhythmia
The Effects of Body Mass Index on Thoracic Paravertebral Block Analgesia

Obesity has become one of the world's leading health problems. It is known that obesity causes many diseases and negatively affects the quality of life. For this reason, many conditions that are thought to be effective in obesity and concern the quality of life of patients have been scientifically researched and continue to be investigated. One of them is postoperative pain. Although there are studies stating that there is no relationship between body mass index (BMI) and postoperative pain, when the literature data is examined, it is thought that obesity is a risk factor for postoperative pain and changes pain sensitivity and analgesic needs of patients. There are also studies in the literature stating that the level of postoperative pain increases in parallel with each unit increase in BMI.

After thoracic surgery, many analgesic methods have been suggested, including thoracic epidural analgesia (TEA), thoracic paravertebral block (TPVB), intercostal nerve blocks (ICSB), erector spina plane block (ESPB), serratus anterior plane block (SAPB). This study will compare the effects of BMI on postoperative pain in patients undergoing TPVB for postoperative analgesia and thoracoscopic surgery.


Eligibility Criteria:
Inclusion Criteria:

* 18 to 80 years old
* ASA physical status I-II-III
* BMI 18 to 40 kg/m2
* Elective video-assisted thoracoscopic surgery

Exclusion Criteria:

* Patient refusing the procedure
* Emergency surgery
* Chronic opioid or analgesic use
* Patients who will operate under emergency conditions
* Patients who will not undergo VATS
Whole Body Vibration Combined With L-citrulline Supplementation on Cardiovascular Function and Body Composition

Arterial dysfunction contributes to the development of cardiovascular disease (CVD), which is currently afflicting millions of individuals. The use of the amino acid L-citrulline has been suggested as a potential aid for the treatment of CVD by increasing endothelial production of Nitric Oxide (NO). Whole body vibration (WBV) is new and effective form of exercise that is feasible for clinical populations and has been proven to decrease blood pressure (BP) and arterial stiffness and increase muscle mass and strength. Therefore, the purpose of this study was to investigate if the combination of WBV training (WBVT) plus L-citrulline supplementation would induce positive additive effects and would be an effective means to ameliorate arterial stiffness, endothelial function, BP and muscle strength/mass in postmenopausal women.

The purpose of this study is to investigate the effects of 8 weeks combination of WBVT plus L-citrulline supplementation on arterial stiffness, endothelial function, BP and muscle strength/mass in overweight/obese postmenopausal women.

The specific aims of the study are:

1. To investigate if the additive effect of 8 weeks of WBVT combined with L-citrulline supplementation are more efficacious than either treatment alone in ameliorating cardiovascular disease risk factors by assessing arterial stiffness (aortic, systemic, and leg), aortic BP and wave reflection, and autonomic function (heart rate variability, vascular sympathetic activity \[low-frequency power of systolic BP variability\], and baroreflex sensitivity). Flow mediated dilation and circulating levels of adipocytokines (adiponectin and leptin) and endothelial-derived vasodilators (NO metabolites \[NOx\], 6-keto PGFIa, insulin, and ghrelin) and vasoconstrictors (endothelin-1 \[ET-1\],8-iso PGF2a,vascular endothelium growth factor \[VGEF\]) will be assessed as secondary outcome variables.
2. To evaluate the extent to which 8 weeks of WBVT combined with L-citrulline improves body composition assessed by changes in fat mass and lean mass using dual-energy x-ray absorptiometry and waist circumference.
3. To determine the additive effect of 8 weeks of WBVT combined with L-citrulline supplementation on muscle strength. These will be evaluated using the eight-repetition maximum test for the leg press and chest press exercises

Eligibility Criteria:
Inclusion Criteria:

Female 50 to 70 years of age At least 1 year after menopause Body mass index of 27-39.9 Sedentary or low active (less than 2 hr per wk)

Exclusion Criteria:

Younger than 50 or older than 70 years of age Body mass index lower than 27, or 40 or higher Physically active or competitively active Smoker Use of hormone replacement therapy of less than 1 yr Use of calcium channel blocker or beta blockers Use dietary supplementations (e.g.,L-arginine,L-citrulline,antioxidants) Uncontrolled diabetes Any restriction that would significantly interfere with compliance with the L-citrulline supplementation
Reduction of Bladder Injection Pain With Belladonna Opiate Suppository

The purpose of this study is to test whether using belladonna \& opiate suppositories (B\&Os) can improve patient discomfort during Onabotulinumtoxin A (BoNT) injection into the bladder for treatment of overactive bladder, neurogenic detrusor overactivity, or interstitial cystitis.


Eligibility Criteria:
Inclusion Criteria:

* Met clinical criteria under outside care or during the Principal Investigator's routine standard of care for BoNT injection therapy
* No contraindication to BoNT therapy as outlined by drug manufacturer guidelines
* Participants have elected to have the BoNT injection therapy prior to being offered enrollment into the study for either overactive bladder (OAB), neurogenic detrusor overactivity (NDO), or refractory interstitial cystitis (IC)

Exclusion Criteria:

* Currently pregnant
* Currently nursing a baby
* Anticipated geographic relocation within the first 3 months following treatment
* Allergy to morphine, belladonna, or opiates
* Patients will be excluded if participating in another research study
* Individuals unable to provide informed consent or to complete two-week follow-up bladder testing (post-void residual) or data collection will also be excluded
Evaluation of the Safety of C-Spine Clearance by Paramedics

The goal of this cohort study is to evaluate the safety and potential impact of an active strategy that allows paramedics to assess very low-risk trauma patients with the Canadian C-Spine Rule (CCR) and transport them to the Emergency Department without immobilization. The specific objectives of the study are to determine safety, determine the clinical impact and evaluate performance.


Eligibility Criteria:
Inclusion Criteria:

* consecutive alert, stable adults evaluated by the paramedics with potential c-spine injury after sustaining acute blunt trauma. Patient eligibility will be determined at the time of paramedic arrival at the scene based on the following criteria:
* "Potential c-spine injury after sustaining acute blunt trauma" will include patients with either:

  * neck pain with any mechanism of injury (subjective complaint by the patient of any pain in the posterior aspect of the neck),
  * no neck pain but some visible injury above the clavicles, and/or
  * neither neck pain nor visible injury, but significant mechanism of injury as determined by the paramedic at the scene.
* "Alert" is defined as a Glasgow Coma Scale score of 15 (converses, fully oriented, and follows commands).
* "Stable" refers to normal vital signs(systolic blood pressure 90 mm Hg or greater and respiratory rate between 10 and 24 breaths per minute).
* "Acute" refers to injury within the past 4 hours.

Exclusion Criteria:

* Patients under the age of 16 years,
* Patients with penetrating trauma from stabbing or gunshot wound,
* Patients with acute paralysis (paraplegia, quadriplegia),
* Patients with known vertebral disease (ankylosing spondylitis, rheumatoid arthritis, spinal stenosis, or previous cervical spine surgery), or
* Patients referred from another hospital and transported between facilities.
OptiSense™ Performance in Detecting Atrial Episodes

The SENSE-AF study aims to determine the performance of the OptiSense lead in sensing fine episodes of Atrial Tachyarrhythmia/Atrial Fibrillation (AT/AF) and rejecting Far-Field R Wave (FFRW). The performance of the lead will be measured as a difference in device-determined time in AT/AF and surface-ECG determined time in AT/AF. This measurement will be compared to the control group which will be randomized to receive SJM's Tendril™ RA leads.


Eligibility Criteria:
Inclusion Criteria:

* Patients who meets current ICD or CRT-D implant indications and receive a St. Jude Medical ICD/CRT-D
* Patients who will receive a new St. Jude Medical OptiSense or Tendril RA lead as part of their device implant

Exclusion Criteria:

* Patients with a history of Permanent or Persistent AF
* Patient's life expectancy is less than 12 months.
* Patient is pregnant.
* Patient's age at enrollment is less than 18 years.
Minor Salivary Gland Transplantation for Cicatrizing Conjunctivitis

This is a prospective study that aimed to observe the therapeutic effects of minor salivary gland transplantation for cicatrizing conjunctivitis patients.

Cicatrizing conjunctivitis can be the common presentation of many ocular surface diseases as Stevens-Johnson syndrome (SJS), mucous membrane pemphigoid (MMP), chemical burn, Sjogren syndrome, chronic graft-versus-host disease (GVHD) and ocular trauma. Ocular dryness in combination with symblepharon and corneal opacity in these patients could lead to the poor visual and life quality, and less favorable prognosis of ocular reconstruction.

This study aims to prospectively evaluate the therapeutic effects of minor salivary gland transplantation for cicatrizing conjunctivitis. The investigators evaluate the saliva-tear productivity (functional outcome) and the survival of graft (anatomical outcome) every three months. The investigators would also validate whether minor salivary gland transplantation is beneficial for the participant prior to further ocular reconstruction as limbal transplantation and corneal grafting.

Eligibility Criteria:
Inclusion Criteria:

* age 20-85 years old
* unilateral or bilateral cicatrizing conjunctivitis
* severe aqueous deficiency dry eye ( Schirmer I test result of less than 2mm)
* chronic ocular surface disease score (COCS) over 3 points
* Oxford scheme over grade III

Exclusion Criteria:

* active ocular infection
* active corneal melting
* severe xerostomia (modified Schirmer I test result of less than 25mm)
Volatility in Paranoia (VIP) Trial: An RCT of Changes in Volatility With Psychotherapy

The goal of this clinical trial is to learn whether learning and belief updating change in response to the treatment of persecutory delusions, in individuals with schizophrenia-spectrum disorders.

The main questions are:

1. do prior expectations about environmental volatility reduce following effective psychotherapeutic treatment of delusions?
2. does corresponding brain activity related to volatility change with effective treatment of delusions?

Participants will:

1. engage in CBTp or TAU + phone check-ins for 16 weeks
2. complete assessments at 4 timepoints over the course of 6 months
3. complete an MRI when possible


Eligibility Criteria:
Inclusion Criteria:

* Men and women age 18 - 65.
* Communicative in English.
* Premorbid IQ \>79 (WTAR)
* Provide voluntary, written informed consent.
* Stable medication regimen over at least the past two weeks, including the use of either an oral or intramuscular administration of an antipsychotic medication.
* Diagnosis of a non-affective psychotic disorder (e.g. schizophrenia, schizoaffective disorder, schizophreniform disorder, delusional disorder)
* A persecutory delusion scoring at least a 3 on the conviction scale of the Psychotic Symptoms Rating Scale (PSYRATS) that had persisted for at least two months and that was not considered the direct result of substance use.

Exclusion Criteria:

* Serious medical or neurological illness known to interfere with cognitive functioning (uncontrolled/unstable diabetes, uncontrolled hypothyroidism, Cushing's disease, Lupus, any demyelinating disease such as Multiple Sclerosis, HIV infection, CNS infection, unstable heart disease, active hepatitis, other significant endocrine condition, any cancer involving the CNS/brain, any uncorrected vision problems, tardive dyskinesia).
* History of severe head trauma with loss of consciousness \>30 minutes.
* Primary diagnosis of alcohol or substance use disorder or personality disorder
A Multi-center Study of the Effect of Orthokeratology on Myopia Progression

This is a prospective study to validate an algorithm for predicting the effect of orthokeratology on myopia progression in children from 8 hospitals in China.

Orthokeratology (ortho-K) is thought to be an effective way to control the progression of Myopia in children, but its effectiveness may vary among different individuals. The investigators therefore conducted a prospective, multi-center study to use an algorithm to predict the progression of myopia among Chinese children wearing Orthokeratology lenses.

Eligibility Criteria:
Inclusion Criteria:

* -6.0D≤SER≤-0.5D
* Astigmatism≤2.0D

Exclusion Criteria:

* Contraindications of wearing Ortho-K.
* Diagnosis of strabismus, amblyopia and other refractive development of the eye or systemic diseases.
* Currently involved in other clinical studies.
The Course of Low Back Pain

This study aims to research the possible associations of education level, sedentary lifestyle, and type of low back pain (radicular vs non-radicular) with the course of low back pain and recovery rate.


Eligibility Criteria:
Inclusion Criteria:

* Low back pain
* Age 18 years or older

Exclusion Criteria:

* Pregnancy
Study of ABT-869 in Subjects With Advanced Renal Cell Carcinoma Who Have Previously Received Treatment With Sunitinib

This study is designed to determine the clinical efficacy and toxicity of ABT 869 in the treatment of subjects with advanced renal cell carcinoma who have previously received treatment with sunitinib.


Eligibility Criteria:
Inclusion Criteria

* Subject has undergone previous nephrectomy.
* Subject has received at least 2 cycles (12 weeks) of treatment with sunitinib for RCC and stopped therapy due to progressive disease within 100 days prior to screening.
* Subject has measurable disease, defined as at least 1 unidimensionally measurable lesion on a CT scan as defined by RECIST.
* ECOG Performance Score of 0-1.
* No history of another active cancer within the past 5 years.Life expectancy of at least 4 months.
* Willing to take adequate measures to prevent pregnancy.

Exclusion Criteria

* Subject has received anti-cancer therapy within 21 days or within a period defined by 5 half lives, whichever is shorter, prior to study drug administration.
* Subject has untreated brain or meningeal metastases.
* Subject has received a tyrosine kinase inhibitor (TKI) other than sunitinib or sorafenib.
* Prior use of Avastin is allowed.
* The subject is receiving therapeutic anticoagulation therapy.
* The subject has a history of/or currently exhibits clinically significant cancer related events of bleeding (e.g., hematuria, hemoptysis).
* The subject currently exhibits symptomatic or persistent, uncontrolled hypertension defined as diastolic blood pressure (BP) \> 100 mmHg; or systolic blood pressure (BP) \> 150 mmHg.
* The subject has a history of myocardial infarction within 6 months of Study Day 1.
* The subject has a documented left ventricular (LV) Ejection Fraction \< 50%.
* The subject has known autoimmune disease with renal involvement (eg, Lupus).
* Female subjects who are pregnant or breast feeding.
* Subject is receiving anti-retroviral therapy for HIV.
* Subject has a clinically significant uncontrolled condition(s) including but not limited to:

  * active uncontrolled infection,
  * Class III or IV heart failure as defined by the New York Heart Association functional classification system,
  * unstable angina pectoris or cardiac arrhythmia,
  * history of adrenal insufficiency,
  * psychiatric illness/social situation that would limit compliance with study requirements;
  * Active, ulcerative colitis, Crohn's disease, celiadisease or any other conditions that interfere with absorption.
  * Subject has a medical condition, which in the opinion of the study investigator places them at an unacceptably high risk for toxicities.
Short-Term Effects of Connective Tissue Massage After Hysterectomy

The aim of this study to investigate the effects of connective tissue massage (CTM) on pain, intestinal peristaltism and functionality after total laparoscopic (TLH) or abdominal hysterectomy (TAH). Patients who underwent TLH randomly group as TLH-CTM (n=15) and TLH control (n=16), and TAH randomly group as TAH-CTM (n=14) and TAH control (n=15). The postoperative daily monitoring sheet, Visual Analogue Scale (VAS), time of intestinal peristaltism employees to collect research data.

Interventions In the control groups (TLH control and TAH control) only in-bed activities and walking recommendations will be given, and routine care (analgesics and wound care) applies. In addition, CTM applies in the CTM groups (TLH-CTM and TAH-CTM).

Connective tissue manipulation: The patients are informed about CTM and its mechanism of action before starting the CTM application. CTM is performed by a trained physiotherapist as the patient was in a sitting position. All posterior connective tissue areas (sacral, lumbar, lower thoracic, scapular, inter-scapular, and cervical) are stimulated. Both short and long strokes will use during the manipulation. Each stroke will repeate three times, first on the right and then on the left of all desired zones. All sessions will terminated with long bilateral strokes to the iliac crest and subcostal regions. During manipulation, the pad of the middle finger will be in contact with the patient's skin. Application will take approximately 30-35 minutes depending on the area treated. CTM will apply twice: at postoperative 3rd hour and after 24 hours.

Routine care and advising: In-bed activities will advice to the patients in both groups. In-bed activities are; rotation, sitting on the bedside, breathing exercises, range of motion exercises for upper and lower extremities. In addition, hourly walking activities are recommended after the anesthetic effect wore off. Vital signs (pulse rate, blood pressure, and respiratory rate) and body temperatures will evaluate regularly. The investigators, will determine the severity of severe pain with the VAS scale. According to the VAS scale, if the patient reports pain intensity between 7-10 out of 10, it means that she has severe pain. Patients will encourage for early ambulation. Initially, they walked 10-15 m inside their rooms and the amount of walking increased over time.

Eligibility Criteria:
Inclusion Criteria:

* volunteered to participate in the study,
* those who underwent benign abdominal or laparoscopic hysterectomy,
* who were stable at post-operative vital signs and those with no complications in the early postoperative period

Exclusion Criteria:

* they had oncological diseases,
* chronic pain history, prolapse,
* those who had previous abdominal surgery,
* those with known psychological problems. For the CTM groups,
* those with local infection (abscess etc.), open lesion/wound, scar tissue, edema, and hematoma in the lumbar region.
Safety Trial of High Dose Oral Vitamin D3 With Calcium in Multiple Sclerosis

Vitamin D likely plays a role in the geography of Multiple Sclerosis (MS), and patients at risk and with MS have relatively low Vitamin D levels compared to their normal counterparts.

This trial examines the safety of high dose oral Vitamin D3 titrated up to a maximum of 40,000 IU per day over a 12 month period. Fifty patients matched for MS and non-MS characteristics will be divided into two groups: one group receiving the high dose Vitamin D regimen, and the other restricted to a maximum of 4000 IU per day. The hypothesis is that patients with MS can tolerate seemingly high doses of Vitamin D3 without adverse events and/or calcium-related abnormalities. It is also hypothesized that those receiving the higher doses will demonstrate improved relapse and disability status compared to controls, and that the treatment group will show improved markers of bone health and immune indicators of reduced inflammation.


Eligibility Criteria:
Inclusion Criteria:

* Clinically definite MS
* Age 18-55
* EDSS 0-6.5

Exclusion Criteria:

* EDSS =\> 7.0
* Current Vitamin D3 use \>4000 IU/d
* Baseline (25(OH)D) level \<20 mmol/L (frank deficiency) and \>150 mmol/L
* Pregnancy or inability/unwillingness to use contraception
* History of cardiac arrhythmia
* History of renal disease and nephrolithiasis
* History of granulomatous disease or lymphoma
* Relapse activity or steroid use in the past 60 days
Translation and Validation of the French Version of Confusion Assessment Method for the Intensive Care Unit

Validity and Reliability of French Version of the Confusion Assessment Method for the Intensive Care Unit (psychometric validation study after translation/back translation process assessed by the original team : W.Ely, MD, Ph.D, Vanderbilt University)


Eligibility Criteria:
Inclusion Criteria:

* Adult, \> or equal to 18-yr
* Richmond Agitation Sedation Scale (RASS) \> or equal -3
* Francophone

Exclusion Criteria:

* Diagnostic of cognitive disorders
* Admission for brain injury
* Psychotic disorders
* Diagnostic of cognitive disorders
* Visual or auditory impairments
Emotional Processing in Healthy Volunteers in the Presence of an Investigational Anxiolytic

This will be a phase I, single centre, randomised, double blind, double-dummy, placebo controlled, parallel group single-dose study in healthy volunteers. The purpose of this study is to assess the effect of a single-dose administration of GSK424887, a potent, selective competitive antagonist of the human Neurokinin 1 (NK1) receptor and a potent inhibitor of the human serotonin transporter (SERT), at the maximum dosage of 100 mg versus placebo and versus citalopram (20 mg) on emotional processing in healthy male volunteers. Pharmacokinetics and safety following oral administration of GSK424887 will be also evaluated. An Emotional Test Battery (ETB) previously used to characterise the effects of antidepressants on positive and negative emotion processing in Healthy Volunteers and patients will be used. We hypothesise that GSK424887 will modulate emotional information processing acutely. We anticipate that these effects may be manifest at sub-effective levels of NK1 and SERT receptor occupancy, thus providing pharmacodynamic evidence of the synergistic interaction of the two mechanisms in humans.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy males with no neurological, or history of psychiatric illness
2. Aged between 18 and 45 years
3. Agree to use contraception
4. BMI range of 18 to 33 kg/m²
5. Fluent English speakers
6. Non smoker or light smoker

Exclusion Criteria:

1. Positive pre-study drug/alcohol screen or regular alcohol consumption
2. Positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
3. On prescription or non prescription drug
4. Exposure to more than four new chemical entities within 12 months prior to the first dosing day
5. Consumption of large amounts of caffeinated drinks
6. Significant hearing impairment
7. Previous experience of the emotional test battery experimental procedures