cyrilzakka/clinical-trials huggingface dataset:
Effect of Aerobic Exercise on Diurnal Cortisol Pattern in Premenstrual Syndrome

The aim of this study will be to investigate the effect of aerobic exercise on diurnal cortisol pattern in premenstrual syndrome.

Premenstrual syndrome is manifested by recurrent emotional and depressive symptoms that may be associated with maladaptive coping with stress situations and the enhanced release of stress hormones, like cortisol hormone. Although previous studies revealed a flattened diurnal cortisol slope in women with PMS compared to healthy controls, there is no previous work on the effect of aerobic exercise on diurnal cortisol pattern in premenstrual syndrome. Therefore, this study will aim to investigate the effect of aerobic exercise participation on diurnal cortisol pattern in premenstrual syndrome.This trial will include two groups; group (A) will consist of 14 females who will receive relaxation training for 8 weeks, while group (B) will consist of 14 females who will receive the same relaxation training along with aerobic exercise for 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Sedentary, virginal, adult, non-smoker females suffering from premenstrual syndrome.
2. They should have regular menstrual cycles (cycles of 21-35 days with a bleeding time of 3-10 days)
3. They should have the following criteria in daily record of severity of problems in at least one of two consecutive menstrual cycles prior to treatment starting to confirm premenstrual syndrome diagnosis: a) more than three items have an average score over 3 during the luteal phase, and b) a luteal phase score is 30% more than a follicular phase score.
4. No traumatic life events in the last 2 months before starting the study.
5. Their age will be 18-23 years
6. Their body mass index (BMI) will be less than 30 kg/m2.

Exclusion Criteria:

1. Menstrual problems (e.g. menorrhagia, metrorhagia and polycystic ovary disease).
2. Cardio-respiratory, renal, neurological and pelvic inflammatory diseases, tumors, infections, anemia, diabetes, hypertension, asthma, rheumatoid arthritis, headache, migraine, thyroid or mental disorders.
3. Participation at any other exercise training program during this study.
4. Receiving any kind of medications, hormonal treatment or supplementation (vitamin, mineral or herbal supplement).
Noise, a Risk for Heart in Airplane Pilots

Study of noise generated by military-type aircraft and equipment maintenance in relation to non-auditory effects that impact with the body of the crew and ground staff can cause cardiac pathologies

Hypothesis of work: The pilots and the technical personnel of maintenance that work before the exhibition of noise generated by planes hunt F-16, or equipments of maintenance of the same ones, present major risk of a cardiac affectation, which demonstrates in changes in the normal pace of the heart, in his function of bomb or in hemodynamic conditions.

The work area military airport is characterized by low frequency noise in sound pressure levels exceeding 100 dB, smashing into the body of pilots and ground staff.

It found variations in the thickness of the pericardium and deviation measures ejection fraction

Eligibility Criteria:
Inclusion Criteria:

* exposure to noise from military aircraft

Exclusion Criteria:

* inactive personal or vacation
A Study of MK0777 in the Treatment of Outpatients With Generalized Anxiety Disorder (0777-020)

The study will look at the effect of MK0777on reducing anxiety in subjects with general anxiety disorder.

This is an early phase trial and some specific protocol information is in progress and not publicly available at this time. (Full information is available to trial participants).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of General Anxiety Order

Exclusion Criteria:

* Women who are pregnant or breast-feeding
* History of severe drug reaction
* History of severe drug withdrawal symptoms such as seizures or delirium
* Disease of cardiovascular system
* Disease of the liver, kidneys, endocrine system, metabolic system or eyes
* History of seizures or seizure disorder
* History of drug or alcohol abuse
Neocytolysis in the Treatment of Renal Anemia With Erythropoieses Stimulating Agents (ESA)

The purpose of this study is to gain information on reticulocyte neocytolysis in patients treated with ESA with regard to different types of ESA.


Eligibility Criteria:
Inclusion Criteria:

* signed informed consent
* age \> 18 years, dialysis dependent chronic renal failure
* hemodialysis three times a week
* Kt/V \> 1,2 od URR \> 65%
* hemoglobin between 11 and 13 g/dl within the last 2 months
* hemoglobin change +/- 1g/dl within the last 4 weeks
* ESA for at least 8 weeks
* Ferritin \> 300 ng/ml and Tsat \> 25%

Exclusion Criteria:

* Significant bleeding in the last 8 weeks
* blood transfusion within the last 8 weeks
* hemoglobin disorder
* hemolysis
* Malignant disease
* Significant inflammation
* Acute infection
* CRP \> 30 mg/l
* Temporary vascular dialysis access
* Vitamin B12 deficiency
* Folic acid deficiency
* Not controlled hyperparathyroidism
* Not controlled hypertension
* Epilepsia within thze last 6 months
* Thrombocyte count \> 500 x 10\^9 /l
Effects of Vitamin D Supplementation in Subjects With New Onset of Type 1 Diabetes

In this placebo controlled study the investigators aim to investigate the effects of vitamin D supplementation in subjects with new onset of type 1 diabetes on immunological, endocrine and metabolic parameters.

This is a bicentric, randomized placebo controlled, double blind study, with the aim to evaluate the effect of vitamin D supplementation in subjects with new onset of type 1 diabetes on immunological, endocrine and metabolic parameters.

The primary study goal is to evaluate the influence of vitamin D supplementation on the number and function of the master regulatory T-cells under controlled conditions within 13 months. The secondary study goals are a comprehensive immune phenotyping to determine whether Vit D produces changes consistent with a general improvement in immune homeostasis that supports ß-cell tolerating interventions, the assessment of ß-cell function in all subjects to obtain preliminary data on the effects of Vit D on ß-cell survival.

Eligibility Criteria:
Inclusion Criteria:

* males or females \> 6 years
* new onset of type 1 diabetes (3 months)

Exclusion Criteria:

* pregnancy
* hypercalcemia (\>2,65 mmol/L)
* chronic disease including a long-term medication over 4 weeks per year (except type 1 diabetes)
Prevalence of NCD Risk Factors in Kazakhstan

This is a cross-sectional study that aims to study the prevalence of risk factors of noncommunicable diseases in people aged 18 to 69 years using the standardized and adopted STEPS questionnaire in the Republic of Kazakhstan.

The WHO STEPwise Approach to NCD Risk Factor Surveillance (STEPS) is a simple, standardized method for collecting, analysing and disseminating data on key NCD risk factors in countries. The survey instrument covers key behavioral risk factors: tobacco use, alcohol consumption, physical activity, unhealthy diet, as well as key biological risk factors: overweight and obesity, raised blood pressure, raised blood glucose, and abnormal blood lipids.

Eligibility Criteria:
Inclusion Criteria:

* Age Limits 18-69 years
A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative Colitis

The purpose of this study is to evaluate the effectiveness and safety of ozanimod (RPC1063) in achieving and maintaining clinical remission. Ozanimod will be administered orally to pediatric participants with moderate to severe active ulcerative colitis (UC) who have had an inadequate response to conventional therapy.


Eligibility Criteria:
Inclusion Criteria:

* Moderately to severely active Ulcerative Colitis (UC) diagnosed prior to the Screening Visit
* Evidence of UC extending beyond the rectum, as determined by baseline endoscopy
* Has had an inadequate response, loss of response to, or is intolerant to at least 1 of the following treatments for UC: oral aminosalicylates, systemic corticosteroids, immunomodulators, biologic therapy

Exclusion Criteria:

* Diagnosis of Crohn's disease or indeterminate colitis
* Has documentation of positive test for toxin producing Clostridium difficile, or polymerase chain reaction examination of the stool
* Apheresis within 2 weeks of randomization
* History of or currently active primary or secondary immunodeficiency, or participants with known genetic disorders as a cause for colitis

Other protocol-defined inclusion/exclusion criteria apply
Effects Of GW876008 On The Bowel In Patients With Irritable Bowel Syndrome

The purpose of this study is to see if GW876008 in Irritable Bowel Syndrome patients will reverse stress-induced hypersensitivity, by looking at thresholds for perception and pain.


Eligibility Criteria:
Inclusion criteria:

* Must have irritable bowel syndrome.

Exclusion criteria:

* Subjects who have been taking any medication for the treatment of irritable bowel syndrome within 6 months prior to the start of the study.
Organic Diet in Pregnancy and Risk Markers of Health Effects (The OrgDiet Project)

The OrgDiet project is a two-armed (1:1), open, intention-to-treat randomized controlled trial. The aim is to examine effects of consumption of organic foods (intervention group) vs. conventional foods (control group) during pregnancy in both mother and child. About 100 participants will be included and the participants will be followed until the children are two years old. Both groups will also be recommended to eat according to the dietary guidelines of the Directory of Health in Norway.


Eligibility Criteria:
Inclusion Criteria:

* Nulli- or multipara pregnant in first trimester

Exclusion Criteria:

* Consuming an organic diet regularly
* Using medication regularly that might interfere with study adherence or - outcomes
* Diagnosed with a chronic disorder or cancer
* Having a food allergy or intolerance
Medication Development in Alcoholism: Apremilast Versus Placebo

The primary hypotheses under test are that alcohol dependent subjects treated with apremilast will report decreased craving for alcohol following alcohol exposure in the laboratory and report significantly less drinking under naturalistic conditions, than those treated with placebo.


Eligibility Criteria:
Inclusion Criteria:

* Male or female volunteers, 18-65 years of age
* Meets DSM-5 criteria for current alcohol use disorder of moderate or greater severity (AUD-MS)
* In the month prior to screening, reports drinking ≥ 21 standard drinks per week if male, ≥ 14 if female, with at least one heavy drinking day (≥ 5 males, ≥ 4 females) per week.
* Subjects will not be seeking treatment because the medication studies are not treatment trials, and to avoid exposing treatment-seekers to alcohol cues
* Subjects must be abstinent a minimum of 3 days (but not more than 7 days) prior to the human lab session
* Negative BAC and a CIWA score of \< 9 at time of lab session to eliminate acute alcohol or withdrawal effects on dependent measures.
* In acceptable health in the judgment of the study physician, on the basis of interview, medical history, physical exam, EKG, routine urine and blood chemistry.
* Females with childbearing potential must have a negative pregnancy test on the screening, randomization, and lab session visits and agree to use effective birth control for the duration required by a given study.
* Able to provide informed consent and understand questionnaires and study procedure
* Willing to comply with the provisions of the protocol and take daily oral medication.

Exclusion Criteria:

* Active suicidal ideation, as systematically assessed with the Columbia Suicide Severity Rating Scale.
* Meets DSM-5 criteria for a major psychiatric disorder, including mood or anxiety disorders or substance use disorders other than alcohol or nicotine
* Has a urine drug screen (UDS) positive for substances of abuse other than alcohol.
* Significant medical disorders that will increase potential risk or interfere with study participation as determined by the study physician
* Known hypersensitivity to apremilast
* Treatment within the month prior to screening with (1) an investigational drug, (2) medications which may negatively interact with study medications, or (3) drugs that may influence study outcomes (e.g., disulfiram \[Antabuse\], naltrexone \[ReVia\], acamprosate \[Campral\], anticonvulsants, or antidepressants).
* Ongoing treatment with medications that may increase risk, including prescribed, over-the-counter, and herbal preparations, as determined by the study physician.
* Sexually active female subjects with childbearing potential who are pregnant, nursing, or refuse to use effective methods of birth control for the duration required by a specific protocol.
* No fixed domicile and/or no availability by home or mobile telephone
* History of hypersensitivity to the study drug or the ingredients.
* Failure to take double-blind medication as prescribed.
Technological Devices in Circumcision

It aims to investigate the effect of circumcision on the pain and anxiety level of children who are circumcised by watching videos/playing games during the procedure. Previous studies have been conducted to explain the procedure with informative videos and games before circumcision, and reductions in anxiety and pain levels have been detected. The research will start with hospitalization and end with a check-up after discharge.


Eligibility Criteria:
Inclusion Criteria:

* Circumcision for medical or religious reasons.

Exclusion Criteria:

* Children with chronic diseases.
* Children with genital medical problems.
* Children with mental and communication disabilities and their parents.
Modified Thoracoabdominal Plane Block and Rectus Block Combination

The aim of our study was to investigate the effect of the combination of Modified thoracoabdominal plane block (M-TAPA) and rectus sheath block with local infiltration analgesia on postoperative pain scores and opioid use.


Eligibility Criteria:
Inclusion Criteria:

* Over 18 years old
* ASA1-2
* Laparoscopic cholecystectomy cases

Exclusion Criteria:

* Bleeding disorders
* Anticoagulant use
* Patients with previous nerve damage
* Lack of patient consent
* Patients with liver and kidney failure
* Patients allergic to local anesthetics used
* Patients with BMI \> 35
Safety and Efficacy Study of SHP465 in Adults Aged 18-55 Years With Attention-deficit/ Hyperactivity Disorder (ADHD)

The study is designed to evaluate the efficacy and safety of each dose of SHP465 (12.5 and 37.5 mg) given to participants daily in the morning compared to placebo in the treatment of adults aged 18 to 55 years diagnosed with ADHD.


Eligibility Criteria:
Inclusion Criteria:

Subject must be 18-55 years of age

Subject is able to provide written, personally signed and dated informed consent.

Subject is willing and able to comply with all of the testing and requirements defined in the protocol

Subject, who is a female, must not be pregnant.

Subject must have a satisfactory medical assessment with no clinically significant or relevant abnormalities.

Subject has a primary diagnosis of ADHD.

Subject has an adult ADHD-RS with prompts total score ≥28 at the baseline visit.

Subject must have a minimum level of intellectual functioning, as determined by the investigator.

Subject is able to swallow a capsule.

Subject is currently not on ADHD therapy or is not completely satisfied with any aspect of their current ADHD therapy.

Exclusion Criteria:

Subject has a current, comorbid psychiatric diagnosis with significant symptoms.

Subject is considered a suicide risk in the opinion of the investigator

Subject has a body mass index (BMI) of \<18.5 kg/m2 at the screening visit.

Subject has a BMI ≥40 kg/m2 at the screening visit.

Subject has a concurrent chronic or acute illness, disability, or other condition.

Subject has a history of seizure, a chronic or current tic disorder, or a current diagnosis of Tourette's disorder.

Subject has a history of moderate to severe hypertension.

Subject has a known history of symptomatic cardiovascular disease

Subject has a known family history of sudden cardiac death or ventricular arrhythmia.

Subject has any clinically significant ECG or clinically significant laboratory abnormality at the screening visit.

Subject has current abnormal thyroid function

Subject has a documented allergy, hypersensitivity, or intolerance to amphetamine or to any excipients in the investigational product.

Subject has failed to respond, to an adequate course(s) of amphetamine therapy.

Subject has a history of suspected substance abuse or dependence disorder.

Subject has a positive urine drug result at the screening visit (with the exception of subject's current stimulant therapy, if any) or Subject has taken another investigational product or has taken part in a clinical study within 30 days prior to the screening visit.

Subject has previously completed, has discontinued, or was withdrawn from this study.

Subject is taking any medication that is excluded or has not been appropriately washed out according to the protocol requirements.

Subject is required to take or anticipates the need to take medications that have CNS effects or affect performance.

Subject is female and is pregnant or lactating.
IGG Using in Laparoscopic Gastrectomy for Locally Advanced Gastric Cancer After Neoadjuvant Chemotherapy

Patients with locally advanced gastric adenocarcinoma (cT2-4a N-/+ M0) were selected as study subjects to investigate the safety, efficacy, and feasibility of ICG near-infrared imaging tracing in guiding laparoscopic D2 lymph node dissection for gastric cancer after neoadjuvant chemotherapy by comparing injection ICG group and non-injection ICG group


Eligibility Criteria:
Inclusion Criteria:

1. Age from 18 to 75 years
2. Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
3. cT2-4a, N-/+, M0 at preoperative evaluation according to the AJCC Cancer Staging Manual, 8th Edition
4. No distant metastasis, no invasion of pancreas, spleen or other adjacent organs in the preoperative examinations
5. Performance status of 0 or 1 on the ECOG (Eastern Cooperative Oncology Group) scale
6. ASA (American Society of Anesthesiology) score I to III
7. Written informed consent

Exclusion Criteria:

1. Women during pregnancy or breast-feeding
2. Severe mental disorder
3. History of previous upper abdominal surgery (except for laparoscopic cholecystectomy)
4. History of previous gastric surgery (including ESD/EMR for gastric cancer)
5. Enlarged or bulky regional lymph node (diameter over 3cm) supported by preoperative imaging.
6. Other malignant disease within the past 5 years
7. History of previous neoadjuvant chemotherapy or radiotherapy
8. History of unstable angina or myocardial infarction within past six months
9. History of cerebrovascular accident within past six months
10. History of continuous systematic administration of corticosteroids within one month
11. Requirement for simultaneous surgery for other disease
12. Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
13. FEV1 (forced expiratory volume in one second)\<50% of predicted values
14. Diffuse invasive gastric cancer
15. Preoperatively, tumors involving the squamocolumnar junction or duodenum were confirmed
16. A history of iodine allergy
17. Refuse laparoscopic surgery
Microbiome Determinants of Neurological and Gastrointestinal Symptoms of Autism Spectrum Disorder (ASD)

This observational study aims to identify human microbiome determinants of the symptoms associate with ASD as well as identify the human microbiome determinants of the success of FMT (fecal matter transplant) therapy and to develop a statistical model that can improve FMT donor-recipient matching. Participants are recruited through NovelBiome only, this study will NOT utilize other clinical sites.

This longitudinal, observational study aims to identify human microbiome determinants of the symptoms associate with ASD as well as identify the human microbiome determinants of the success of FMT therapy and to develop a statistical model that can improve FMT donor-recipient matching.

Participant phenotype data and samples are collected at several time points relative to their receiving FMT therapy.

Participants will collect stool, urine, environmental swabs, saliva, and blood at home via VLS's (Viome Life Sciences) at-home kits mailed to them by VLS. The at-home samples are collected by participants (and when appropriate LAR/guardian). The samples are then returned to VLS via postage-paid mailers (provided). These samples are analyzed by the VLS laboratory.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of ASD, from medical records, self-diagnosed and/or LAR reported (LAR = legally authorized representative)
* Plans to undergo FMT treatment at a Novel Biome Clinic
* Consented to participate in the study

Exclusion Criteria:

* Active cancer therapy
* Antibiotic use within 30 days prior to starting the FMT therapy. FMT therapy itself starts with antibiotic treatment.
Timing of Weight Bearing After Hallux Valgus Surgery

Investigate the optimal timing for weight bearing after Hallux Valgus surgery. Hypothesis: Early weight bearing does not affect outcome after the Endoscopic Distal Soft Tissue Procedure for Hallux Valgus Correction.

Introduction:

* Rehabilitation plans after hallux valgus/bunion surgery is varied
* From a patient's perspective, full weight bearing is paramount for quality of life and return to work/study
* No high-level study showing the optimal time to resume full weight bearing available

Hypothesis:

Early weight bearing (at 2 weeks post-op) does not affect outcome after the Endoscopic Distal Soft Tissue Procedure for Hallux Valgus correction

Trial Design:

* Parallel group
* Random allocation
* Operating Surgeon blind to randomisation

Study Setting:

* General Regional Hospital
* Single Centre

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing the EDSTP recruited

Exclusion Criteria:

* Cases requiring additional procedures (eg 2nd toe correction)
* Mental incapacitation
* Physical disability hindering rehabilitation (eg CVA, neurological disorder)