cyrilzakka/clinical-trials huggingface dataset:
Effect of Prebiotics Versus Low FODMAPs Diet on Intestinal Microbiota and Symptoms

It has been shown that patients complaining of gas-related symptoms significantly improve on a diet low in fermentable residues. However, other studies suggest that some non-absorbable, fermentable meal products (prebiotics) that serve as substrate to colonic bacteria, produce beneficial effects to the host, including improvement of abdominal symptoms. The aim of the study is to compare the effects of a diet low in fermentable residues versus a diet suplemented with prebiotics on intestinal microbiota composition, microbiota activity (intestinal gas production) and digestive symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Functional digestive disorder with flatulence
* Women and men between the ages of 18 and 80 years (bounds included at the inclusion visit).
* Normal body weight or with overweight (body mass index between 18.0 and 30.0 kg/m2 (bounds included)).
* Women of childbearing potential should be using or complying with one of the medically approved methods of contraception such as, but not exclusively, one of the following:

  1. Birth control pill
  2. Intra-uterine device (IUD)
  3. Double barrier methods (such as condoms and spermicide)
  4. Abstinence
* Willing to follow strict dietary instructions for the duration of the study
* Able to communicate well with the investigator and to comply with the requirements for the study.

Exclusion Criteria:

* Significant illness other than functional bowel disorders
* Disease/disorders which can interfere with the collection of the gas (hemorrhoids,..etc)
* Antecedents of digestive surgery, excluding appendicectomy
* Intake of antibiotics in the month (within 30 days) preceding the inclusion visit.
* Current use of any medications with potential central nervous system effects as judged by the investigator (including but not limited to antidepressants, anxiolytics, opiate pain medications)
* Taking drugs that might modify gastrointestinal function
* Change of dietary habits within the preceding 4 weeks (for instance start of a diet high in fiber) or planned change (For example to start a diet) during the period of the study
Fetal Head Circumference as a Predictor of Operative Delivery

This study set out to investigate whether antenatal ultrasound evaluation of the Fetal Head Circumference (FHC) could potentially possess a predictive role in determining women at increased risk for operative delivery or cesarean section.

When vaginal delivery poses a danger to the mother or newborn infant, operative delivery (instrumental or cesarean section) is indicated. Some specific indications for operative delivery include prolonged second-stage of labor, suspected compromise of the fetus, health-related disorders of the fetus or the mother that justify shortening of the second-stage of active labor and more. In cases where cephalo-pelvic disproportion (CPD) is suspected or when instrumental delivery is not possible or fails, cesarean section plays a critical role . Studies trying to identify women at greatest risk of CPD have concluded that neither x ray, nor computed tomography or magnetic resonance imaging have a proven value in labor management or in predicting clinical outcomes . Previous studies assessing fetal factors that are associated with operative delivery have focused mainly on estimated fetal weight to predict macrosomia. Nonetheless, ultrasound estimation of the fetal weight was shown to differ by as much as 20% from actual birth weight, and identifying cases with suspected fetal macrosomia, other than for diabetic pregnancies, was not found to improve labor outcome . As weeks may possibly elapse between the time of last antenatal assessment and onset of labor, a further challenge is related to the timing of ultrasound assessment. Several studies have shown an association between increased Fetal Head Circumference (FHC) and prolonged second-stage of labor, instrumental delivery and cesarean section . However, FHC can only be acquired following delivery and has no predictive value for interventions in labor.

Eligibility Criteria:
Inclusion Criteria:

1. Women at term (37+0 - 42+0 weeks' gestation)
2. Singleton pregnancies
3. Cephalic presentation
4. Anticipated vaginal delivery

Exclusion Criteria:

1. Younger than 18 years old and older than 45 years old
2. Women who incapable of providing informed consent
The Attitudes of Doctors Working in the Surgical Clinic of Patient Blood Management

The attitudes of doctors working in the surgical clinic of a university hospital for patient blood management: a survey-based study


Eligibility Criteria:
Inclusion Criteria:

- Being a doctor working in the surgical clinics of the university hospital

Exclusion Criteria:

* INQUIRING SURVEY QUESTIONS
The Effect of the Training Program Provided to Primipara Pregnant Women Through the Motivational Interview Method on Their Fear of Childbirth, Childbirth Self-Efficacy and Delivery Mode

This two-group, parallel randomized controlled study was conducted to evaluate the effect of the training program provided to primipara pregnant women through the motivational interview method on their fear of childbirth, childbirth self-efficacy and delivery mode. The primipara pregnant women included in the study sample were assigned to the intervention (n=37) and control (n=36) groups using the block randomization method. The women in the intervention group were individually provided with "Training Program on Fear of Childbirth Based on Motivational Interview Method" once a week, four sessions in total, while no interventions were made for those in the control group other than routine hospital practices. Study data were collected using a descriptive information form, the Wijma Delivery Expectancy/Experience Questionnaire (W-DEQ) versions A-B, the Childbirth Self-Efficacy Inventory-Short Form (CBSEI-SF) and the Delivery Evaluation Form. The value of p\<0.05 was accepted statistically significant in the data analyses.


Eligibility Criteria:
Inclusion Criteria:

* Ability to read and write in Turkish
* Not contraindicated for vaginal delivery
* Absence of any pregnancy-related complications
* Absence of chronic systemic disease
* Absence of communication problems
* Absence of psychiatric problems
* No abnormalities in the fetus
* 24th and 28th weeks of pregnancy

Exclusion Criteria:

* Premature birth (before 37th weeks of gestation)
* Pregnancy complication developed at any stage of the study (such as preeclampsia, placenta previa, oligohydramnios, gestational diabetes)
* A cesarean section is planned at any stage of the study due to a medical indication,
* Did not complete the training program
* Giving birth outside the province
* Not seen within 24 hours after birth
Efficacy and Safety Study of Ozanimod in Relapsing Multiple Sclerosis

This study is a two-part trial consisting of Part A (see NCT01628393) and Part B, presented within this record.

The primary objective of Part B is to assess whether the clinical efficacy of ozanimod (RPC1063) is superior to interferon beta-1a (IFN β-1a; Avonex®) in reducing the rate of clinical relapses at the end of Month 24 in patients with relapsing multiple sclerosis (RMS).

This clinical trial (RPC01-201; RADIANCE) consisted of 2 parts, each reported separately on ClinicalTrials.gov: Part A (NCT01628393) and Part B (this record).

Part A was a phase 2 study in which two doses of ozanimod were administered daily for 24 weeks with an efficacy and safety comparison to a placebo control and is reported separately as ClinicalTrials.gov record NCT01628393.

Part B, reported herein, was a phase 3 study in which two doses of ozanimod were administered daily for a 24 month period compared to an active control, interferon β-1a. Participants were allowed to enroll in the open-label extension study RPC01-3001 (NCT02576717) or complete the study with a safety follow-up visit 28 days after their last dose of study treatment.

Eligibility Criteria:
Inclusion Criteria:

* Multiple sclerosis as diagnosed by the revised 2010 McDonald criteria
* Expanded Disability Status Scale (EDSS) score between 0 and 5.0 at baseline

Exclusion Criteria:

* Primary progressive multiple sclerosis
Survey on Practice and Comparison With Best Evidence in Surgical Site Infection Prevention in Colorectal Surgery

Web-based survey to colorectal surgeons assessing knowledge, beliefs and practices regarding the use of preventative measures for SSI.

A web-based survey (SurveyMonkey©; https://es.surveymonkey.com/r/FBVR59C) to the members of the Colorectal Chapter of the Spanish Association of Surgeons (AEC) and the Spanish Association of Coloproctology (AECP). A link to the web page containing the survey is disseminated via email, newsletter and Twitter.

A board from the Surgical Infection Section did a review of evidence and previous guidelines to be used in the evaluation of the results. The most recent clinical practice guidelines have been analysed. Furthermore, an extensive review of specific measures for colorectal surgery has been published and used for evaluation. According to the review, the preventive measures analysed in the survey have been distributed into two groups: high or low level of evidence.

The survey aim to assess knowledge, beliefs, and practices of attending colorectal surgeons on preventative measures including mechanical bowel preparation (MBP), oral antibiotic prophylaxis and the use of drains. Furthermore, the questions address the level of accordance between their beliefs and the protocols or the usual practice of their units. The agreement rate between the beliefs and usual practice of all respondents will be calculated on a scale from 0 to 100. For discussion, the responses on the implementation of major surgical site infection (SSI) prevention measures will be compared with the recommendations of the expert group. Other questions are related to the types of complications that surgeons believe are prevented by the use of oral antibiotic prophylaxis or MBP, reasons for not using either of them, type of oral and systemic antibiotics and cathartics used, and strategies already in place or that should be implemented to reduce SSI rates at respondents' hospitals.

The results will be expressed in percentages on the total answers obtained. Responses will be entered into a computerized database that will be analysed using the SPSS program (v.10.0, Chicago, IL, USA). The results will be analysed using the chi-square test with statistical significance defined as p \<0.05.

Eligibility Criteria:
Inclusion Criteria:

* Colorectal surgeons members of the Colorectal Chapter of the Spanish Association of Surgeons (AEC) and the Spanish Association of Coloproctology (AECP)

Exclusion Criteria:

* none
Laboratory Study of Cannabidiol on the Effects of Smoked Marijuana

The objective of this study is to assess the effects of oral cannabidiol (CBD; 0, 200, 400, 800 mg) on smoked marijuana's (0, 5.6% THC) subjective, reinforcing, cognitive, and cardiovascular effects. This experiment is expected to reveal CBD's intrinsic effects when combined with placebo marijuana, as well as its ability to modulate the behavioral effects of active marijuana.

Marijuana contains many chemicals called cannabinoids. The ingredient mainly responsible for marijuana's psychoactive effects is called THC (delta-9-tetrahydrocannabinol. Another cannabinoid in marijuana is cannabidiol. It is found in smaller quantities than THC. Cannabidiol is thought to interfere with the effects of THC. Therefore, synthetically produced cannabidiol is given to healthy marijuana users in this study to test its capability to reduce the high of THC and, thereby, help to relieve addiction to marijuana.

Eligibility Criteria:
Inclusion Criteria:

* Adults between the ages of 18 and 50.
* Current marijuana use: Minimum of four times per week, 0.5 joints per occasion during the preceding 4 weeks.
* Able to perform study procedures
* Women practicing an effective form of birth control

Exclusion Criteria:

* Female subjects who are currently pregnant or breastfeeding.
* Current, repeated illicit drug use other than marijuana
* Presence of significant medical illness
* History of heart disease
* Request for drug treatment
* Current parole or probation
* Recent history of significant violent behavior
* Major psychiatric disorder
Treatment for Sleep Disturbance in Orthopaedic Trauma Patients

The purpose of the study is to test the efficacy of sleep treatment in human patients following traumatic injury. Specifically, the study will determine if treatment consisting of melatonin and education related to sleep habits are effective in treating sleep disturbance and improving sleep quality in Orthopaedic trauma patients. We hope to learn if melatonin and sleep education effectively improve sleep following traumatic injury, and improve outcomes.


Eligibility Criteria:
Inclusion Criteria:

* New patients visiting the Orthopaedic Trauma Clinic or undergoing orthopaedic surgery in Stanford Hospital following traumatic injury. Accidental traumatic fracture injuries that are operative and non-operative. Must be able to swallow tablets.

Exclusion Criteria:

* Documented head trauma. Cognitive impairments. Minors. Previously diagnosed sleep disorders. Sleep apnea. Enrolled in another study. Women who are pregnant or may become pregnant or are nursing. Hypertension. Diabetes. Endocrine, autoimmune, depressive, bleeding or seizure disorders.
Transoral Daytime Neuromuscular Electrical Stimulation in Patients With Simple Snoring

Sleep Disordered Breathing (SDB) is a spectrum of conditions spanning from Simple Snoring to Severe Sleep apnea. SDB has multiple underlying mechanisms. Some portion of patients have issues with upper airway dilator muscle control; and such patients may be amenable to upper airway muscle training exercises using neuromuscular stimulation techniques. The investigators and others have published on the topic of neuromyopathy in the upper airway, defining a subgroup of OSA patients who may be amenable to training exercises. Based on this background, the investigators seek to test the hypothesis that upper airway tongue muscle training using transoral surface neuromuscular electrical stimulation may have benefits to patients with Simple Snoring.


Eligibility Criteria:
Inclusion Criteria:

• Confirmation of snoring: must have a live-in bed partner that reports ≥ 6 months history of habitual snoring (i.e. \> 5 days per week)

Exclusion Criteria:

* AHI \> 15/hr
* BMI \> 35
* Non-English speakers (due to necessity to complete questionnaires)
* Inability to complete daily neuromuscular stimulation
* Other sleep disorders
* Tongue or lip piercing
* Pacemaker of implanted medical electrical devices
* Current or recent (within last 6 months) treatment for snoring or sleep apnea
* Previous oral or pharyngeal surgery other than dental
* Craniofacial skeletal or muscular abnormalities
* History of driving or other accidents due to sleepiness or an Epworth score (ESS)\> 18
* Pregnant
* Cardiac (other than hypertension), pulmonary, renal, neurologic, neuromuscular or hepatic disease
* Medications with sedative or myorelaxant properties or effects on cardiac or pulmonary function
* Substantial alcohol (\>3oz/day) or use of illicit drugs
* Psychiatric disorders (other than depression or anxiety)
* Snoring less than 20% of total sleep time during baseline polysomnography
Derivation of New Human Embryonic Stem Cell Lines: Identification of Instructive Factors for Germ Cells Development

The purpose of this study is

1. To generate human embryonic stem cells lines (hESC) lines
2. Study of the factors that contribute to differentiation towards germ cell.


Eligibility Criteria:
Inclusion Criteria:

* any donated embryos

Exclusion Criteria:

* not relevant
A Study of AL-38583 Ophthalmic Solution 0.05%, 0.010% Versus AL-38583 Vehicle for Dry Eye

The purpose of this study is to determine whether AL-38583 ophthalmic solution is effective for treatment of signs and symptoms of dry eye.


Eligibility Criteria:
Inclusion Criteria:

* Composite corneal staining score of greater than 5 in one or both eyes.
* Schirmer II score of greater than 4 mm.
* OSDI score of greater than 23.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Any medical condition (systemic or ophthalmic) that may, in the opinion of the investigator, preclude the safe administration of the test article or safe participation in this study.
* Other protocol-defined exclusion criteria may apply.
Individualized PEEP Setting by EIT in Patients With ARDS

The investigators conducted a pilot study to compare the effect of Positive End Expiratory Pressure(PEEP) setting guide by lung electrical impedance tomography(EIT) and ARDS-net PEEP-FiO2 table on survival in subjects with mild/severe Acute Respiratory Distress Syndrome(ARDS).


Eligibility Criteria:
Inclusion:

1. acute respiratory distress syndrome with ratio of partial pressure of arterial oxygen over fraction of inspired oxygen (PaO2:FiO2)\<300 and PEEP \>5cmH2O
2. Body mass index \< =40
3. Written inform consent

Exclusion:

1. pregnant，intracranial hypertension
2. left ventricular dysfunction (EF\<25% )
3. Patients with end-stage conditions(death expected within 90 days)
Open Label Extension Study of HT-100 in Patients With DMD

This study is designed to provide 6-months continuous dosing with the study medication, called HT-100, on participants who successfully completed the predecessor study (HALO-DMD-01). The main purpose of this study is to assess chronic safety, tolerability, pharmacodynamic activity (testing the drug's effect on DMD) and population pharmacokinetics (measuring how much drug is in the bloodstream) in participants with a broad spectrum of Duchenne muscular dystrophy (DMD).


Eligibility Criteria:
Inclusion Criteria:

* Completed both the single ascending dose (SAD) and multiple ascending dose (MAD) phases of predecessor study HALO-DMD-01
* Maintained the same corticosteroid therapy from the predecessor study HALO-DMD-01
* Ability to provide written informed consent
* Ambulatory or non-ambulatory

Exclusion Criteria:

* Recent, substantial change in use of cardiac medications or medications affecting muscle function
* Clinically significant major disease, not related to DMD
* Significantly compromised cardio-respiratory function
* History of severe allergic or anaphylactic reactions
* Prior treatment with another investigational product in past 6 months
* Inability to undergo magnetic resonance imaging (MRI)
* Current drug or alcohol abuse or prior treatment for abuse
Using 3D Imaging to Optimize Bifurcation Stenting

The primary purpose of this study is to determine whether bifurcation stenting guided by on-line three-dimensional optical frequency domain imaging (3D-OFDI) is superior to that with angiographic guidance by measuring incomplete stent apposition (ISA) in the bifurcation segment.

The recently developed optical frequency domain imaging (OFDI) can provide high quality resolution images of the coronary arteries. This new imaging system enhances the understanding of complex coronary lesions and the complex interaction between coronary devices and vessels by assembling/compiling 2-dimensional cross sections.

This 3-dimensional reconstruction with strut segmentation becomes possible on-line in the TERUMO OFDI console with 3-dimensional imaging software, which enables stent enhancement and 3D reconstruction within one minute. This "real time" 3D OFDI will promote the utilisation of 3-dimensional assessment in the treatment of bifurcation lesions.

Eligibility Criteria:
Inclusion Criteria:

1. Patient is at least 18 years of age and signed Informed Consent
2. Subject has coronary artery disease involving a bifurcation with objective evidence of ischemia including patients with chronic stable angina, silent ischemia and non-ST segment elevation acute coronary syndrome (NSTE-ACS)
3. Subject is appropriate to be treated by PCI according to the local practice (operator's judgment or heart team decision)
4. Patients' residence is in the area covered by the hospital
5. Patients with angiographically significant stenosis (\>50 % by visual assessment) in de novo, native, previously unstented bifurcation lesion(s) including left main lesion, which is in operator's opinion appropriate to be treated by PCI with a single stent strategy
6. The size of main vessel matches available Ultimaster stent sizes (\<4.0 mm, and 2.0 mm by visual assessment)
7. The size of side branch is \>2.0mm in diameter by visual assessment
8. The sidebranch is treatable with a sidebranch fenestration and/or kissing balloon

Exclusion Criteria:

1. Pregnancy
2. Patients with ST elevation myocardial infarction
3. Known intolerance to aspirin, clopidogrel, heparin, cobalt chromium, sirolimus, contrast material
4. Known thrombocytopenia (platelet count\< 100,000/mm3)
5. Cardiogenic Shock
6. Significant comorbidities precluding clinical follow-up (as judged by investigators)
7. Major planned surgery that requires discontinuation of dual antiplatelet therapy
8. History of stenting in the target bifurcation lesion
9. Renal insufficiency (GFR/MDRD \<45 ml/min), which precludes in operator's opinion contrast injection during repeat OFDI pullback
10. Severely tortuous or angulated coronary anatomy of the study vessel that in the opinion of the investigator would result in sub-optimal optical frequency domain imaging (OFDI) or excessive risk of complication to place an OFDI catheter
11. Target lesion reference vessel diameter (RVD) \< 2.25 and \> 4 mm
12. Other: Patient is judged inappropriate by the attending physician
A Prospective Study, Single-arm, Multicentre, Observational to Evaluate Safety and Effectiveness of Stent Ultimaster Tansei Coronary Stent in Complex Coronary Lesions.

This prospective registry is intended to evaluate the safety and efficacy of the TANSEI stent.

This prospective registry is intended to analyze clinical outcomes in patients treated with TANSEI stent in patients with complex coronary lesions .

Eligibility Criteria:
Inclusion Criteria:

* Age\> 18 years.
* With indication of percutaneous revascularization.
* Complex coronary lesion defined as:

  * Left main lesion AND/OR
  * Lesion located at a major bifurcation (side branch \>2mm) AND/OR
  * Lesion located in a small vessel (\<2.5 mm reference diameter by visual estimation) AND/OR
  * Lesion length \> 35 mm
* Informed consent signed.

Exclusion Criteria:

* Cardiogenic shock at the time of the PCI(Percutaneous Coronary Intervention).
* Life expectancy of the patient under 1 year.
* Patients included in other studies or clinical trials.
* Clinical decision that excludes the use of drug-eluting stents.
* Confirmed allergy to aspirin and / or thienopyridines.