cyrilzakka/clinical-trials huggingface dataset:
Gut- and Vaginal Microbiome Composition in Association With PCOS

Polycystic ovary syndrome (PCOS) is an endocrine disorder that affects up to 10% of the reproductive-aged women worldwide. The etiology is still unknown and treatment therefore remains symptomatic. Studies indicate a possible role of the gut microbiome in the pathology of PCOS. PCOS women have a disturbed gut microbiome, with certain species associated with the PCOS characteristics:hyperandrogenism, ovarian dysfunction, obesity, glucose intolerance and insulin resistance. Although differences have been found in gut microbiome composition between PCOS and healthy women, the literature is inconclusive regarding the difference in gut microbiome biodiversity. Studies examining the vaginal microbiome in PCOS women show consistent results with specific species in the vaginal microbiome. However, there are only few studies on the vaginal microbiome in PCOS women and no studies have yet investigated the correlation between sex-specific hormones and PCOS characteristics. More research is needed to understand the function of the microbiome in the pathophysiology of PCOS, so that this can offer perspectives in future therapies.


Eligibility Criteria:
Inclusion criteria

* Caucasian
* Willing to provide vaginal swab and stool sample
* Willing to provide informed consent
* Sufficient command of the Dutch language
* Diagnosed with PCOS at Erasmus MC using the Rotterdam criteria by the presence of at least two of the following criteria
* Clinical or biochemical hyperandrogenism (modified Ferriman-Gallway score \>5; testosterone level \>2nmol/L, Free Androgen Index \> 2.9)
* Oligomenorrorrhea or amenorrhea
* Polycystic ovaries.

Exclusion criteria

* BMI \<18
* Smoking
* Diabetes Mellitus or use of insulin sensitizer
* Chronic and acute infection diseases
* Endometriosis (American Fertility Score (AFS) III/IV)
* Elevated prolactin levels, thyroid disease, Cushing disease or gastro-intestinal disease
* The use of hormonal contraceptives, and other steroid hormones in the last 3 months
* Use of antibiotics, probiotics or laxatives in the last 3 months
Comparison of Body Weight Change During Contraception With Belara and Yasmin

The purpose of this study is to evaluate different side effect in contraceptive use of two oral combined contraceptive pills (OCP)in combination of 30 mcg ethinylestradiol/2 mg chlormadinone acetate (Belara®) and 30 mcg ethinylestradiol/3 mg drospirenone (Yasmin®), especially body weight change.

Oral combined contraceptive pills (OCP) is the most contraceptive use in reproductive women. The various type of progestins in OCP give various effects either benefit (non-contraceptive benefit) and side effect. These effects depend on pharmacological activity of each progestin. Many studies showed causes of discontinuation use of OCP, such as increase body weight,androgenic effect and vaginal spotting. OCP in combination of 30 mcg ethinylestradiol/2 mg chlormadinone acetate (Belara®) and 30 mcg ethinylestradiol/3 mg drospirenone (Yasmin®)are the common used in practice. The each type of progestin (chlormadinone and drospirenone) might effect different outcomes in women especially in body weight change during use. Chlormadinone is a C-21 progestin which has glucocorticoid and antiandrogenic effect. Drospirenone is a progestin in spironolactone derivative which has antimineralocorticoid and antiandrogenic effect. Both progestins might has less effect in body weight change and provide other non-contraceptive benefits. So investigator want to study the different effects from these progestin in two type of OCP. The result from this study could give information to choose the proper OCP for each reproductive woman.

Eligibility Criteria:
Inclusion Criteria:

* Reproductive woman
* Woman who has BMI \< 28.5 kg/m2.
* Woman who has regular menstruation.
* Woman who don't have pelvic organ disorder.
* Woman who want contraception with oral contraceptive pills.

Exclusion Criteria:

* Woman who has abnormal blood pressure
* Woman who has abnormal vaginal bleeding
* Pregnant woman
* Woman who on medication effect contraceptive pills, such as anti-fungal, anti-retroviral, anti-convulsant drug.
* Woman who has contraindication for OCP.
* Woman who use steroid in 3 month period before enrollment in this study.
* Smoking
* Woman who has eating habit disorder.
A Study to Evaluate and Study Drug Levels in Blood Plasma When Giving High Doses of GSK189075 to Healthy Volunteers

This study will assess safety and tolerability when taking GSK189075 at doses that are likely to be higher than the expected prescribed doses. The study will also measure the level of GSK189075 in blood after dosing as well as the effect of the drug on certain laboratory tests performed on volunteer urine and blood. Each volunteer will take part in 3 dosing periods and will be given a different dose level at each period (either 2000mg, 4000mg, or a placebo). Volunteers will not know which of the three doses they are receiving. In each period, volunteers will dose every morning for three straight days. Before and after dosing, blood pressure, heart rate, laboratory tests on blood and urine, physical examinations and ECGs will be taken to assess safety. Volunteers will also be asked to provide information should they feel they are having a possible effect from the GSK189075. The levels of GSK189075 in the blood will be assessed by multiple blood draws, most of these will follow the third dose in each period. Depending on the results from the preceding periods, a fourth period may be added to the study to assess another dose level. The fourth period, if this is to occur, will be the same design as the other three periods, and the dose received will be less than 4000mg.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males and non-pregnant females as determined by a physician on the basis of medical history (including family history of heart disease), physical examination, and clinical laboratory tests.
* written consent given
* agreement to follow specific requirements of birth control during participation.

Exclusion Criteria:

* history of drug or alcohol abuse within one year of the study screening.
* use of tobacco or nicotine-containing products with 6 months prior to the study screening.
* use of any prescription or non-prescription drugs, vitamins, herbal, and dietary supplements within 14 days of the start of the study.
* blood donation within 56 days before the start of the study
* receiving other investigational drugs or participating in other research trials within 30 days of the start of this study.
Femoral Artery Blood Flow During Rest and One-leg Knee Extensor Exercise in Patients With COPD

Doppler ultrasound is generally considered to provide reliable femoral blood flow measurements between rest and exercise, and the blood flow response to exercise is widely believed to be reduced in patients with chronic obstructive pulmonary disease (COPD). However, the test-retest reliability of the method during one-leg knee extensor exercise has not previously been compared between matched healthy individuals.

Experimental assessments of changes in skeletal muscle blood flow during exercise in humans are important for elucidating the factors that limit exercise capacity and adaptations, both in healthy humans, including athletes, as well as in various disease states with functional impairment, such as chronic obstructive pulmonary disease COPD). A classical 'gold standard' for measuring blood flow is thermodilution, and this has notably applied to provide data on femoral blood flow during exercise. Because thermodilution required invasive catheterization, many have replaced it with Doppler ultrasound, but the test-retest reliability of Doppler ultrasound in this context is unknown. However, many studies have used Doppler ultrasound to document that the femoral blood flow response to exercise is impaired in COPD, which ultimately affects oxygen uptake and thus exercise capacity, but the interpretation of these findings is currently hampered by the lack of knowledge regarding the test-retest reliability of the method in this patient group.

The investigators aim is to compare the femoral blood flow response to one-legged knee extensor exercise in patients with COPD vs. healthy participants, and to provide an estimate of the test-retest reliability the femoral blood flow measurements obtained by Doppler ultrasound.

Eligibility Criteria:
Inclusion Criteria for COPD patients:

* Men and women
* 45-80 years
* COPD (GOLD stage I to III)
* Forced expiratory volume in 1 sec (FEV1)/forced vital capacity ratio (FVC) \< 0.8, FEV1 \< 90% of predicted value
* Modified Medical Research Council score (mMRC 0 - 3) Resting arterial oxygenation \> 90%

Exclusion Criteria for COPD patients:

* Symptoms of ischaemic heart disease
* Known heart failure
* Claudication
* Symptoms of disease within 2 weeks prior to the study
* Participation in pulmonary rehabilitation within 6 months
* Known malignant disease
* Pregnancy
* Unstable cardiac arrhythmic disease
* Renal or liver dysfunction

Inclusion Criteria for healthy matched controls:

* Men and women
* 45-80 years
* Normal FEV1, FVC, FEV1/FVC, and single-breath diffusion capacity
* Same sex, age (± 3 years) as the COPD patients

Exclusion Criteria for healthy matched controls:

* Known chronic lung disease
* Known ischaemic heart disease
* Known heart failure
* Symptoms of disease within 2 weeks prior to the study
* Known malignant disease
* Claudication
* Pregnancy
* Unstable cardiac arrhythmic disease
* Renal or liver dysfunction
Dendritic Cell Immunotherapy for the Patients With Pancreatic Cancer

The trial evaluates the safety and efficacy of MUC-1/WT-1 peptide and/or tumor lysate-pulsed dendritic cell Immunotherapy for the patients with pancreatic cancer

The trial evaluates the safety and efficacy of dendritic cell Immunotherapy for the patients with pancreatic cancer. Dendritic cells are obtained from blood monocytes using standard protocol.

Two options for dendritic cell priming are used: MUC-1/WT-1 peptides for the patients with unresectable tumor and/or tumor lysates for the patients undergoing tumor resection.

The dendritic cells are them matured and injected subcutaneous (all patients) and intratumorally (when possible).

Eligibility Criteria:
Inclusion Criteria:

* histologically or cytologically confirmed pancreatic cancer (adenocarcinoma);
* HLA-A2 expression by tumor cells;
* WT-1/MUC-1 expression by tumor cells.

Exclusion Criteria:

* refuse of patient to participate in the trial;
* pregnancy/lactation;
* intercurrent severe chronic diseases;
* HIV, Hepatites B/C;
* active tuberculosis;
* alcohol use disorder/drug addiction.
A Randomized, Double-Blind, Placebo-Controlled Study of Oral Milk Immunotherapy for Cow's Milk Allergy

The purpose of this study is to determine if small oral doses of milk protein are safe and effective in decreasing sensitivity to cow's milk in allergic children.

This is a prospective, multi-center, clinical trial involving children aged 6 to 21 years with persistent cow's milk allergy. These children will be recruited from 2 sites (Johns Hopkins and Duke University) and will undergo initial screening and double-blind, placebo-controlled, food challenge (DBPCFC) to confirm threshold dose for reactivity to milk. Patients will be treated with milk oral immunotherapy (OIT) or placebo for 22-30 weeks. Those who reach an adequate maintenance dose for OIT will undergo a second DBPCFC. Those who develop desensitization will continue with daily milk intake and undergo a third DBPCFC. Those in the treatment group who are not desensitized will return to strict avoidance. Those in placebo group will be offered to begin treatment or continue with strict milk avoidance. Symptom and diet information will be collected initially and at regular intervals. Bloodwork, skin prick tests (SPTs), pulmonary function tests (PFTs), and oral secretion samples will be done initially and at periodic intervals.

Eligibility Criteria:
Inclusion Criteria:

* Provide signed informed consent (by parent or legal guardian if the subject is a minor) and informed assent if applicable
* Age 6 to 21 years
* Must have history of symptomatic reactivity to cow's milk (eczema, urticaria, upper/lower resp., GI, other associated rash, oral symptoms)
* History of positive skin prick test (wheal \>/= histamine control) or milk-Immunoglobulin E (IgE)\>0.35 kilounits per liter (kU/L)
* Positive DBPCFC
* All females of child bearing age must be using appropriate birth control

Exclusion Criteria:

* History of anaphylaxis requiring hospitalization
* History of intubation related to asthma
* Has the ability to tolerate \>2.4gram of milk protein at initial DBPCFC
* Has a history of allergy to any component of vehicle
* Pregnancy (need negative test)
* Viral upper respiratory infection (URI) or gastroenteritis within 7days of OFC (OFC needs to be rescheduled)
* Has pulmonary function tests \<80% of predicted (FEV1) or clinical history consistent with moderate persistent asthma
* Currently taking greater than medium dose inhaled corticosteroid (\>400mcg/day fluticasone or fluticasone equivalent if \</=12yo or \>600mcg/day if \>12 years old)
* Antihistamine within 1 week prior to skin testing or food challenges (Skin testing and/or food challenge needs to be rescheduled)
* Systemic corticosteroid within 4 weeks prior to baseline visit
* Receiving omalizumab, beta-blocker, Angiotensin-converting enzyme (ACE) inhibitor or tricyclic antidepressant therapy
* Chronic disease (other than asthma, atopic dermatitis, rhinitis) requiring therapy (e.g., heart disease, diabetes)
* Participation in any interventional study for treatment of a food allergy in the past 12 months
* Severe reaction at initial DBPCFC, defined as:

  i. Life-threatening anaphylaxis ii. Requires overnight hospitalization
To Evaluate the Safety and Efficacy of a New Device in the Management of Mild to Moderate Atopic Dermatitis in Children

The purpose of this study was to evaluate the safety of the investigational study product and see how well it works to relieve signs and symptoms of children with mild to moderate Atopic Dermatitis (AD), also known as eczema, in comparison to that of a similar marketed product. This study was conducted to assess the safety of the investigational new study product and how well it works to treat AD in children, by making AD visually better, and reducing the amount of itch.

This was a multi-center, double-blind, randomized, active-controlled trial in children 2 to 12 years of age with mild to moderate AD. A sufficient number of subjects were screened to ensure that approximately 80 subjects were randomized, to yield 70 completed subjects. Subjects were randomized to one of the two treatment groups: the J\&J Device or Atopiclair®. All subjects were to return to the clinical site for clinical assessments at baseline (Day 1) and at Days 3, 8, 15, 22, 29 and 43 after initial investigational product application. The investigational products were used topically during the duration of the study.

Eligibility Criteria:
Inclusion Criteria:

* Post-menarchal female subjects must have a negative urine pregnancy test
* Willing to provide written informed consent/assent
* Diagnosed as having mild to moderate Atopic Dermatitis (AD)
* Willing to stop all moisturizers and/or other skin barrier cream or emulsion treatments for the AD condition during the test period and replace with the investigational product assigned in this trial
* Willing to replace their body wash and/or soaps with the one provided in this trial

Exclusion Criteria:

* Severe AD as determined by the Rajka-Langeland Severity Index
* AD requiring systemic, super-potent (Class I) or potent (Class II or III) topical corticosteroids. If the subject requires any of these medications as rescue therapy during the study, the subject will be discontinued from the trial
* History of allergy or hypersensitivity to the ingredients of the test devices, nuts or nut oil
* Cutaneous or systemic viral (including HIV or AIDS), mycotic or bacterial disease requiring a topical or systemic therapy
* Diabetes mellitus that cannot be controlled by diet alone (i.e., requires systemic medications for control)
Prospective Outcomes After Reconstruction and Radiotherapy for Breast Cancer

This study examines the aesthetic outcomes of breast reconstruction after mastectomy for breast cancer in patients who require post-mastectomy radiation treatment. Patients will undergo autologous tissue breast reconstruction either in immediate fashion, prior to radiation treatment, or in delayed fashion, after radiation treatment. Both approaches are acceptable and are practiced clinically. this will be an observational prospective cohort study.

The investigators hypothesize that immediate autologous reconstruction patients who undergo subsequent radiation therapy have equivalent aesthetic outcome when compared to those in whom reconstruction is delayed until after radiation, with the additional benefit of avoiding the psychological side effects of breast amputation.

Neo-adjuvant or adjuvant chemo-radiation remains one of the pillars for breast cancer treatment. (1, 2) Administration of radiation before or after autologous soft tissue reconstruction has being shown to alter the aesthetics of the new breast. (3-7) Currently, the optimal timing for autologous breast reconstruction in patients who need postmastectomy radiotherapy remains in debate between surgeons. (8) Various studies have tried to address this problem. However, most of them have been retrospective studies (3, 7, 9) and the prospective ones have not have enough patients, have mixed population of patients or the radiation protocols have not been normalized. (5, 6, 10)

We hypothesize that immediate autologous reconstruction patients who undergo subsequent radiation therapy have equivalent aesthetic outcome when compared to those in whom reconstruction is delayed until after radiation, with the additional benefit of avoiding the psychological side effects of breast amputation.

Eligibility Criteria:
Inclusion Criteria:

* Breast cancer requiring mastectomy and post-mastectomy radiation
* Desire for breast reconstruction after mastectomy

Exclusion Criteria:

* Inflammatory breast cancer
* Age \< 18 years old
* No desire for breast reconstruction
* Women without need for postmastectomy radiation
Pharmacokinetic, Safety, and Tolerability Study of Risperidone ISM® at Different Dose Strengths

This clinical trial is designed to evaluate different dosages of risperidone ISM, a new long-acting injectable form.

This clinical trial will try to characterize and document the pharmacokinetics of risperidone ISM in schizophrenic or schizoaffective patients after one intramuscular injection at different dose strengths.Likewise, the safety and tolerability of risperidone ISM will be evaluated in the above mentioned population.

Following confirmation of eligibility and a washout period for study-prohibited drugs, a total of 33 subjects will be randomized in a 1:1:1 ratio to receive a single intramuscular (IM) injection of one of the following dosages of study drug:

Group 1: 50 mg risperidone ISM Group 2: 75 mg risperidone ISM Group 3: 100 mg risperidone ISM Several blood samples for plasma pharmacokinetic (PK) assessments will be obtained pre-dose and post-dose. Safety assessments will be conducted at each pre-specified time points.

Eligibility Criteria:
Inclusion Criteria:

* Capable of providing informed consent.
* Male or female aged ≥ 18 years to \< 65 years
* Current diagnosis of schizophrenia or schizoaffective disorder, according to the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders Clinical Trials (SCID-CT) or the DSM-IV-TR
* Medically stable over the last month, and psychiatrically stable without significant symptom exacerbation over the last three months based on the investigator's judgment
* Score of ≤ 4 (moderately ill) on the Clinical Global Impression - Severity of Illness (CGI-S)
* If a sexually active female of childbearing potential, using a medically accepted contraceptive method.

Exclusion Criteria:

* Presence of an uncontrolled, unstable, clinically significant medical condition that in the opinion of the investigator may interfere with the interpretation of safety and PK evaluations
* If female, a positive serum pregnancy test, or planning to become pregnant between now and one month after the last dose of trial medication, or currently breastfeeding a child
* History of neuroleptic malignant syndrome and current or past history of tardive dyskinesia
* Positive urine drug/alcohol screen finding, unless the positive finding can be accounted for by documented prescription use.
* In the investigator's opinion, at imminent risk of committing self-harm
* Use of depot antipsychotics within the last three months
* Receipt of any investigational drugs within the last three months
* Current participation in any other clinical trial
The Effects of Low Glycemic Index (GI) Diet on Cardiometabolic Outcomes Among Obese Chinese Adults

The aim of this study is to investigate the effects and the acceptability of low GI diet versus a conventional healthy diet on the BMI and other cardiometabolic risk factors of obese Chinese adults in Hong Kong.

29.9% of persons aged 15-84 in Hong Kong are obese. Obesity poses significant detrimental consequences for one's health. Obese patients have an increased risk of mortality when compared with people with normal BMI. Obesity results in arterial hypertension, hyperlipidaemia, heart disease and type 2 diabetes. Low GI diets have been investigated for their impact on weight control. Evidence showed that low GI diets were effective in lowering body mass index. However, the evidence was usually generated from Western populations, thus excluding the influence of Chinese culture on diet.The aim of this study is to investigate the effects and the acceptability of low GI diet versus a conventional healthy diet on the BMI and other cardiometabolic risk factors of obese Chinese adults in Hong Kong.

A prospective, two-arm randomized-controlled trial will be conducted to examine the effect of a low GI diet education program on cardiometabolic outcomes in Chinese adults with obesity. The intervention group will receive a low GI diet education, including a one-off, 60-minute, face-to-face, educational session conducted by the research nurse for GI knowledge input. An informational booklet will be given out during the education session.Three follow-up telephone calls of fifteen minutes will be conducted by the research nurse at the 2nd, 5th , and 8th weeks after completing the face-to-face education session. While the control group will receive an education pamphlets on obesity and balanced diet.Three follow-up telephone calls of fifteen minutes will be conducted by the research nurse at the 2nd, 5th , and 8th weeks after receiving the pamphlets.

At baseline, demographic and clinical data, including BMI, waist circumference, body fat, blood pressure, fasting plasma glucose, HbA1c, lipid profile, 3-day food diary, International Physical Activity Questionnaire (IPAQ-C), and the sense of fullness will be collected.

On the 12th week, data about the BMI, waist circumference, body fat, blood pressure, fasting plasma glucose, HbA1c, lipid profile, 3-day food diary, IPAQ-C, and the sense of fullness and a questionnaire on the evaluation process will be collected.

Eligibility Criteria:
Inclusion Criteria:

1. BMI \>25.0 kg/m2;
2. Waist circumference \> 90 cm for men and \> 80 cm for women;
3. Aged eighteen years or older;
4. Chinese ethnicity;
5. Can be contacted by telephone;
6. Have the ability to read and understand Chinese; and
7. Can provide informed consent.

Exclusion Criteria:

1. Concurrently participating in any other clinical trials;
2. Concurrently participating in weight control programs;
3. Concomitant intake of weight reduction drugs;
4. Use of calorie restricted diet or specialized diets which contraindicated with low GI diet;
5. Have gastrointestinal problems that would prevent them from following the prescribed diet.