cyrilzakka/clinical-trials huggingface dataset:
BRCA 1/2 Mutation in Korean Patients With Epithelial Ovarian Cancer

PURPOSE: To investigate the prevalence and clinical correlation of the germline BRCA 1/2 mutation in Korean patients with high grade(HG) serous and/or endometrioid epithelial ovarian cancer (EOC).

PATIENTS AND METHODS: In a nationwide case-control study on EOC conducted in Korea between 2010 and 2015, 298 Korean women with HG serous and/or endometrioid EOC were tested for gBRCA 1/2 mutation, regardless of the family history. Mutation screening was performed using the Ion AmpliSeq BRCA 1/2 Panel (Life Technologies, Carlsbad, CA, USA) and Ion PGM platform according to the manufacturer's instructions. Clinical characteristics including survival outcome was assessed in gBRCAm carriers.


Eligibility Criteria:
Inclusion Criteria:

* women 18 years of age and older with previously untreated, HG serous and/or endometrioid EOC, fallopian tube or primary peritoneal carcinoma who consented to genetic testing between 2010 and 2015

Exclusion Criteria:

* women with mucinous , clear cell, low-grade serous or endometrioid, mixed epithelial adenocarcinoma, undiffereniated carcinoma or malignant brenner's tumor
Dose Effect of Tranexamic Acid on the Incidence of Deep Venous Thrombus in Cardiac Surgery

In recent years, the lysine analogs tranexamic acid (TXA) has gained wide use in cardiac surgery as a blood-sparing agent. However, the safety of the drug and its impact on overall outcomes of cardiac surgery remains debated. The current study evaluates the dose effect of TXA on the incidence of deep venous thrombus (DVT) in cardiac surgery with cardiopulmonary bypass. Also, the dose effect of TXA on bleeding and allogeneic transfusion is evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Patients receiving selective cardiac surgery with cardiopulmonary bypass due to coronary, valvular or congenital heart disease
* Written consent obtained

Exclusion Criteria:

* Allergy or contraindication to tranexamic acid
* Severe renal impairment (serum creatinine \>250 μmol/l, or estimated creatinine clearance \<25 ml/min)
* Thromboembolic disease including but not limited to: history of pulmonary embolism, spontaneous arterial thrombosis or familial hypercoaguability (eg. Lupus anticoagulant, protein C deficiency)
* Thrombocytopenia defined as a platelet count \<100,000/ml
* Coagulopathy defined as an international normalized ratio \> 1.5 prior to surgery
* Currently enrolled in another perioperative interventional study
* Pregnancy or lactation
Influence of Beta-glucan Enriched Barley Flour in Bread on Glycemic Response

Objective of the study is to investigate the influence of beta-glucan enriched barley flour as constituent of bread on glycaemic response (GR) in healthy human volunteers. Glycaemic response will be measured as AUC of blood glucose after consumption of barley bread, and compared with white bread.

Objective of the study is to investigate the influence of beta-glucan enriched barley flour as constituent of bread on glycaemic response (GR) in healthy human volunteers. Glycaemic response will be measured as the area under the curve (AUC) of blood glucose after consumption of barley bread(s), and compared with AUC for white bread. Measurements will be done in line with recommendations. In line with recommendations ten healthy human volunteers will be tested to obtain a sufficient statistical power. GR measurement will be based on available carbohydrates. Amount of bread will be standardised to contain 50 g of available carbohydrates. Subjects will consume bread sample with 250 mL of water, within 10-15 minutes. Blood sampling times will be at 0 min (baseline sample), followed by 15, 30, 45, 60, 90 and 120 min after starting to eat the test meal. Glucose levels will be measured in capillary blood. For reference and test meals, the investigators will do at least 2 AUC measurements per subject. AUC calculation will be based on incremental AUC, ignoring area under the baseline. Comparison will be done as the mean of the individual ratios.

The differences between the different products ingested will be analyzed with the statistical test of analysis of variance. In case of failure to find homogeneity in the variances the nonparametric ANOVA, the Kruskal-Wallis test, will be used. The results will be expressed as mean ± standard deviation for each with a significance level of 0.05 for all the statistical tests.

Eligibility Criteria:
Inclusion Criteria:

* Willingness' to participate, self-diagnosed as healthy
* Age: 18-65 years

Exclusion Criteria:

* Allergy or intolerances to ingredients of tested products (bread)
* Renal impairment
* Diagnosed diabetes
* Level of glucose above 5.6mmol/l at first measurement
* Thyroid disease
* Use of medicines for lowering blood fats and/or preparations for weight loss or reducing the absorption of nutrients from the digestive tract
Cannabis for Inflammatory Bowel Disease

Background: The marijuana plant Cannabis has been used for centuries in the medicinal treatment of many disorders and is still the subject of medical research and public debate. Cannabinoids have been purported to alleviate a variety of neurological conditions such as MS-related symptoms including spasticity, pain, tremor and bladder dysfunction. Other neurological conditions like chronic intractable pain, dystonic movement disorders and Tourette's Syndrome were all reported to be alleviated by cannabis use. Cannabis has been used to treat anorexia in AIDS and cancer patients. In gastroenterology cannabis has been used to treat symptoms and diseases including anorexia, emesis, abdominal pain, gastroenteritis, diarrhoea, intestinal inflammation and diabetic gastroparesis.

Cannabinoids have also a profound anti inflammatory effect, mainly through the CB2 receptor. Cell mediated immunity may be impaired in chronic marijuana users. And a potent anti-inflammatory effect of cannabis was observed in rats . Studying the functional roles of the endocannabinoid system in immune modulation reveals that there are no major immune events which do not involve the endocannabinoid system. Cannabinoids shift the balance of pro-inflammatory cytokines and anti-inflammatory cytokines towards the T-helper cell type 2 profiles (Th2 phenotype), and suppress cell-mediated immunity whereas humoral immunity may be enhanced. They are therefore used for various inflammatory conditions including rheumatoid arthritis and asthma. In a mouse model of colitis cannabinoids were found to ameliorate inflammation and there are many anecdotal reports about the effect of cannabis in inflammatory bowel disease. However, there are no methodical reports of the effect of cannabis on inflammatory bowel disease. The aim of the proposed study is to examine in a double blind placebo controlled fashion the effect of smoking cannabis on disease activity in patients with IBD.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with a diagnosis IBD at least 3 months before recruitment will be eligible to the study.
2. Patients with active disease who are resistant to either 5 ASA, steroids or immunomodulators, or who can not receive those drugs due to adverse reactions will be offered the possibility of smoking cannabis at a dose of two cigarettes a day which will contain either regular cannabis or pre treated cannabis as placebo.
3. Disease activity index of either CDAI of more then 200 in Crohn's disease or Mayo score above 3 in UC.
4. Age above 20.

Exclusion Criteria:

1. Patients with a known mental disorder
2. Patients who are deemed to be at a high risk of abuse or addiction to the study drug.
3. Pregnant women
4. Patients who are sensitive to any of the ingredients of the study medication.
5. Patients who are unable to give informed consent.
6. Patients who may need surgery in the near future.
Oxygen Consumption Required by Stroke Patients During Completion of the Modified Rivermead Mobility Index (MRMI)

The aim of this study was to measure the oxygen consumption and peak heart rate achieved during Modified Rivermead Mobility Index (MRMI) assessment in age-matched, healthy and stroke patients, and assess the efficacy of the MRMI tasks for aerobic training in patients with stroke.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of hemisphere stroke
* aged fifty or above
* ambulatory with/ without walking aid
* had ability to provide informed consent and understand the evaluation procedures

Exclusion Criteria:

* brainstem and cerebellar lesion
* unconscious or drowsy
* musculoskeletal, respiratory or other disease that may limit activity of daily livings
* serious cardiovascular disease
The Effect of Laughter Yoga on Nurses' Perceived Stress, Sleep Quality, and Burnout Levels

The aim of the study was to investigate the effects of laughter yoga on nurses' perceived stress, sleep quality, and burnout levels.

In the literature, it has been found that laughter yoga improves mental health and respiratory functions, positively influences sleep, reduces stress, creates positive mood, enhances cognitive functions, reduces pain, and facilitates circulation. Nurses are a high-risk occupational group for stress, sleep problems, and burnout due to their working conditions and patient care burdens. The aim of this planned study is to examine the effects of laughter yoga on nurses' perceived stress, sleep quality, and burnout levels.

The sample size for the experimental study, which will be conducted as a pre-test post-test control group design, was calculated using the G\*Power 3.1.9.7 program. Sample size calculation was performed for the independent-samples t-test. The effect size used in the calculation was based on the results of the study conducted by Çelik and Kılınç (2022). With an effect size of 2.20 (d = 2.20), a 5% error margin (α = 0.05), and 95% power (1-β = 0.95), the sample size for each group was calculated as 6. However, considering the high effect size obtained from the reference study, a recommended effect size of 0.80 (d = 0.50), a 5% error margin (α = 0.05), and 80% power (1-β = 0.80) were used, resulting in a sample size of 26 for each group. Taking into account the possibility of data loss, the sample size for each group was increased by 20%, and a total of 64 participants, with 32 participants in each group, were planned to be included in the sampling. Nurses participating in the study will be stratified according to the units they work in (internal and surgical units) and randomized. In data collection, the Demographic Characteristics Questionnaire, Perceived Stress Scale, Jenkins Sleep Scale, and Maslach Burnout Scale will be used. For data analysis, number percentage distribution and descriptive statistics will be used to describe demographic characteristics. Differences between basic descriptive characteristics of nurses in the experimental and control groups will be analyzed using Chi-square and Fisher's exact tests. The relationship between the scale score averages of the experimental and control groups will be analyzed using independent-samples t-tests and the Mann-Whitney U test.

Eligibility Criteria:
Inclusion Criteria:

* working as a nurse
* over 18 years old

Exclusion Criteria:

* No uncontrolled hypertension
* No history of abdominal surgery in the last three months
* Not suffering from glaucoma, hernia or epilepsy
* Not receiving psychiatric diagnosis and treatment
* Not receiving sleep-related diagnosis and treatment
* having incontinence
Comparison Between Bilateral Infraorbital Block Versus Intranasal Bupivacaine in Transsphenoidal Pituitary Adenoma Resection

The study will evaluate the efficacy of bilateral infraorbital nerve block versus preoperative nasal packing with long-acting local anesthetic bupivacaine in term of maintaining hemodynamics intraoperative within 20% below baseline to achieve adequate hypotensive anesthesia and longer duration of postoperative analgesia up to 24 hours in patients undergoing transsphenoidal pituitary adenoma resection.


Eligibility Criteria:
Inclusion Criteria:

* ASA I, II or III
* patients scheduled to undergo endoscopic transsphenoidal approach to remove tumor under general anesthesia

Exclusion Criteria:

* Patient's refusal
* Allergy to local anesthetics.
* Preoperative cerebrospinal fluid leak.
* Preoperative cardiac arrythmias.
* Seizure disorders.
* Patients with severe endocrinal disorders that affecting the craniofacial morphology as acromegaly and cushinoid features.
Six-Minute Walk Test Comparing Helium/Oxygen to Nitrogen/Oxygen for COPD Rehabilitation

The purpose of this study is to evaluate effects of inspired gas mixtures on the distance walked by patients with severe Chronic Obstructive Pulmonary Disease (COPD) during a Six-Minute Walk test.

the purpose of this study is to evaluate the distance walked by patients with severe Chronic Obstructive Pulmonary Disease (COPD) during a Six-Minute Walk test (6MWT) while breathing Helium/Oxygen 65%/35% compared to either breathing Nitrogen/Oxygen 65%/35% or receiving Non-Invasive Ventilation (NIV) with a FiO2 of 0.35 and to evaluate exercise related symptoms

Eligibility Criteria:
Inclusion Criteria:

* Male or female aged \>= 45 and \<= 75 years old
* Patient with documented clinical diagnosis of stage III/IV COPD
* Patient with stable COPD defined by no significant increase in COPD medication, no treatment for COPD in an emergency, no acute intensive care setting and no intake of antibiotics in the four weeks prior to selection

Exclusion Criteria:

* Inability or contra-indication to perform pulmonary function tests
* Inability or contra-indication to perform the 6MWT with a trolley
* Any contra-indication to receive NIV
* Obese patient having a Body Mass Index (BMI) \> 35
* Pregnant or lactating woman
* Female or chil-bearing potential with lack of efficient contraception
This Study is to Assess the Efficacy of Difamilast Ointment in Mild to Moderate Atopic Dermatitis(AD)

This is a Phase 3 Double Blind multi-center study conducted at 40 investigational sites in United States to assess the efficacy and safety of Difamilast Ointment 1% in subjects ≥2 years of age with mild to moderate atopic dermatitis.


Eligibility Criteria:
Important Inclusion Criteria:

1. Subjects who are male or female ≥2 years of age
2. Subjects and/or their parent(s)/legal guardian(s) (if subject is under the legal age of consent) provide written informed consent in accordance with federal and/or local laws prior to the conduct of any study-related procedures.
3. Subjects who have a diagnosis of AD based on the American Academy of Dermatology AD diagnostic criteria
4. Subjects who have had a diagnosis of AD for at least 6 months prior to Screening visit
5. Subjects who have AD involvement ≥5% to ≤40% of treatable Body Surface Area (BSA) excluding scalp
6. Subjects who have an AD Severity of mild (2) or moderate (3) as measured by the IGA of AD Severity score at screening and baseline visit

Important Exclusion Criteria:

1. Female subjects who are pregnant or breastfeeding or who plan to become pregnant during the study and through 90 days after the last dose of study drug
2. Subjects who have evidence of spontaneous clearance of AD between screening and baseline visits
3. Subjects who have a history of unstable AD as assessed by the Investigator. Unstable AD is defined as disease flares occurring within 4 weeks prior to baseline visit
4. Subjects who have an active or acute skin infection (eg, herpes simplex, herpes zoster, and chicken pox) and/or clinically infected AD
5. Subject with greater than mild depression and suicidal ideation prior to screening or between screening and baseline visits
6. Subjects who have a known history of alcohol abuse or illicit drugs within 6 months prior to screening

Etc.,
Evaluation of Buffer on Immune Response to Oral Polio Vaccine (OPV) in Bangladesh

Hypothesis:

The immunogenicity of oral polio vaccine (OPV) will be enhanced in Bangladeshi infants who receive bicarbonate buffer at the time of polio immunization.

The investigators will conduct a study to evaluate the impact of administering bicarbonate buffer on the serologic responses to oral polio vaccine (OPV) in Bangladeshi infants.

Eligibility Criteria:
Inclusion Criteria:

* infants who are 4-8 weeks old
* residents of study area

Exclusion Criteria:

* received a blood transfusion or any other blood product (such as immune globulin)
* likely to move out of study area within the next four months
* currently enrolled or planning to enroll in another study
* major congenital malformations
* neurologic disorders
* immunodeficiency
Effects of Combining Different Exercise Modes With CPT on Vascular Function and Sleep Quality in Female University Students With SD

Fourteen female college students with sleep disorders (SD) and fourteen with good sleep status were recruited, divided into sleep disorder group (SDG) and control group (CG). Both groups underwent moderate-intensity continuous training (MICT), high-intensity interval training (HIIT), and sprint interval training (SIT). Immediately after exercise, Cold Pressor Test (CPT) was administered, vascular indicators were measured immediately and 30 minutes later. The next day after exercise, participants completed the Pittsburgh sleep quality index (PSQI). Each exercise mode had a washout period of at least 7 days.

Both SDG and CG underwent HIIT, MICT, and SIT interventions. After the exercise, a CPT was conducted, and vascular indicators were immediately measured at the end of the intervention. Another measurement was taken 30 minutes after the intervention. The exercise was performed on a power bike, with the requirement to maintain a pedaling frequency of 60 rpm. The exercise protocols for HIIT, MICT, and SIT were designed with equal exercise volume. The HIIT protocol consisted of 4 sets of 4 minutes at 85% maximal oxygen uptake data (VO2max), interspersed with 3 minutes at 50% VO2max. The MICT protocol involved continuous pedaling at 60% VO2max for 32 minutes. The SIT protocol included 6 sets of 30-second all-out sprints (100% VO2max) with 4.5 minutes of recovery at 60% VO2max between each sprint. There was a minimum of 7 days between each exercise mode as a washout period. The PSQI questionnaire was completed the day after each intervention upon waking up.

Eligibility Criteria:
Inclusion Criteria:

* Female university students aged between 18 and 30 years old
* Body Mass Index (BMI) between 18.5\~24.0 kg/m2
* Presence of SD (PSQI \> 8 points) or good sleep quality (PSQI ≤ 7 points)
* Not taking medications that affect sleep
* No cardiovascular diseases
* No regular exercise habits or specialized training but possessing the ability to complete the exercise program

Exclusion Criteria:

* Severe organic diseases such as heart, kidney, etc
* Metabolic diseases such as diabetes, etc.
* Taking medications that affect sleep (including drugs that promote or interfere with sleep)
* Permanent and severe exercise dysfunction
* Participation in other experiments
Life Style Modification Medical and Surgical Management in Patients With Obesity

In this is an observational study, obese patients that administed and followed in endocrinology clinic of Marmara University Medical school hospital will follow for clinical and laboratory parameters prospectively for 5 years

Following available clinical and laboratory parameters will be collected for 5 years Treatment modalities ( life stye modification, medication, bariatric surgery) eating habits quality of life body mass index , blood pressure body fat distribution (impedance measurement) laboratory parameters (serum glucose, OGTT, insülin, lipids,creatinin ,ALT AST,CBC, ferritin calcium, phosphate, Parathormone,25 OH vitamin D, vitamin B12 ,uric acid, albumin, FSH LH testosteron, estrogen ) muscle strength (dynomometer measurement) skin glikolization autoflouresent measurement Bone mineral density mesurements (femur, spine ,forarm)

Eligibility Criteria:
Inclusion Criteria:

Body mass index over 30 kg/m2 age between 18-65 years

Exclusion Criteria:

active malignancy pregnancy during involvement period chronic inflamatuar diseases
STEP 1: Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity

This study will look at the change in participants' body weight from the start to the end of the study. The weight loss in participants taking semaglutide (a new medicine) will be compared to the weight loss of participants taking "dummy" medicine. In addition to taking the medicine, participants will have talks with study staff about healthy food choices, how to be more physically active and what you can do to lose weight. Participants will either get semaglutide or "dummy" medicine - which treatment participants get, is decided by chance. Participants will need to take 1 injection once a week. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. The study has two phases: A main phase and an extension phase.The main phase will last for about 1.5 years. Participants will have 15 clinic visits and 10 phone calls with the study doctor. Extension phase: Approximately 300 participants will continue in the extension phase in the following countries only: Canada, Germany, the UK and selected sites in the US and Japan. These participants will be in the study for about 2.5 years.They will not receive treatment, but will attend another 5 follow-up visits with the study doctor.


Eligibility Criteria:
Inclusion Criteria:

Main phase:

* Male or female, age greater than or equal to 18 years at the time of signing informed consent
* Body mass index (BMI) greater than or equal to 30.0 kg/sqm or greater than or equal to 27.0 kg/sqm with the presence of at least one of the following weight-related comorbidities (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease
* History of at least one self-reported unsuccessful dietary effort to lose body weight

Extension phase:

* Informed consent for the extension phase obtained before any trial related activities for the extension phase
* On randomised treatment on the target dose at week 68, i.e. treated with 2.4 mg semaglutide once-weekly or semaglutide placebo

Exclusion Criteria:

Main phase:

* Glycated haemoglobin (HbA1C) greater than or equal to 48 mmol/mol (6.5%) as measured by the central laboratory at screening
* A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records

Extension phase:

* Female who is pregnant or intends to become pregnant during the extension phase
* Any disorder, unwillingness or inability, not covered by any of the other exclusion criteria, which in the investigator's opinion, might jeopardise the subject's compliance with the extension of the trial
To Evaluate the Therapeutic Equivalence and Safety in Treatment of Scalp Psoriasis

To demonstrate the superiority of the efficacy of the test and reference products over that of the placebo control in the treatment of scalp psoriasis.

Multi-center, double-blind, randomized, placebo controlled, parallel-group study comparing test and reference products to a placebo control in the treatment of scalp psoriasis

Eligibility Criteria:
Inclusion Criteria:

* Healthy male or non-pregnant female aged ≥18 years
* All male subjects had to agree to use accepted methods of birth control with their partners, from the day of the first application of the study drug to 30 days after the last application of the study drug
* Willing and able to understand and comply with the requirements of the protocol, including attendance at the required study visits
* A clinical diagnosis of stable (at least 6 months) scalp psoriasis involving at least 10% of the scalp

Exclusion Criteria:

* Female subjects who were pregnant, nursing, or planning to become pregnant during study participation
* Known hypersensitivity to calcipotriene, betamethasone dipropionate, other corticosteroids, or to any ingredients in the study drugs
* Current diagnosis of unstable forms of psoriasis including guttate, erythrodermic, exfoliative, or pustular psoriasis