cyrilzakka/clinical-trials huggingface dataset:
Lifestyle Intervention to Prevent the Recurrence of Gestational Diabetes Mellitus

Gestational diabetes mellitus(GDM) is a commom complication during pregnancy and associated with various adverse pregnancy outcomes for both the mother and her offspring. Imoportantly, with the gradual opening of a two-child policy, more and more Chinese women of reproductive age enter pregnancy have a history of GDM. Our previous study showed that regular exercise commenced in early pregnancy is effective in reducing the risk of developing GDM in Chinese overweight and obese pregant women. Thus, in this study, we want to evaluate the effect of lifestyle intervention with detailed information on how to eat and how to diet in preventing the recurrence of GDM.

Gestational diabetes mellitus(GDM) is a commom complication during pregnancy. and the incidence has reached as high as 19.2% in China. GDM is associated with various adverse pregnancy outcomes for both the mother and her offspring, and not only during the perinatal phase, but also in the long term.Thus finding effective way to reduce the risk of GDM is of great importance,especial for women with high GDM risk factors. GDM history is one of the risk factors. Imoportantly, with the gradual opening of a two-child policy, more and more Chinese women of reproductive age enter pregnancy have a history of GDM. Our previous study showed that regular exercise commenced in early pregnancy is effective in reducing the risk of developing GDM in Chinese overweight and obese pregant women. Thus, in this study, we want to evaluate the effect of lifestyle intervention with detailed information on how to eat and how to diet in preventing the recurrence of GDM

Eligibility Criteria:
Inclusion Criteria:

* Singleton;
* non-smoking ;
* before 12+6 weeks gestation.

Exclusion Criteria:

* less than 18 years old;
* unwilling to provide informed consent;
* cervical insufficiency;
* women on any medication for pre-existing hypertension, diabetes, cardiac disease, renal disease, systemic lupus erythematosus, thyroid disease or psychosis;
* women who were currently being treated with metformin or corticosteroids.
Training Endoscopists to Perform On-site Rapid Cytological Evaluation for EUS-FNA of Solid Pancreatic Lesions

In China, there is a serious shortage of pathologists who can perform on-site cytological diagnosis. As a result, there are few centers that can conduct ROSE in China, which limits the diagnostic accuracy of EUS-FNA to a certain extent. Previous research reports on whether endoscopists could be trained for ROSE were controversial, which may be related to the lack of standardization of the training of endoscopists. There is no training program for training endoscopists to systematically process pathological specimens, operate microscopes, read the adequacy of cytological specimens, and evaluate the atypia of cytological specimens in China. Therefore, our center intends to carry out a training for endoscopists to compare the improvement of endoscopists' ROSE operating ability before and after the training, and to evaluate the practice of each endoscopist to perform on-site rapid cytology specimens of solid pancreatic lesions.


Eligibility Criteria:
Inclusion Criteria:

1. age ≥18 years
2. diagnosis or suspected of solid pancreatic mass based on previous imaging examination;
3. EUS-FNA is achievable.
4. signed informed consent letter

Exclusion Criteria:

1. pregnant female
2. pancreatic cystic lesions
3. anticoagulant/antiplatelet therapy cannot be suspended
4. unable or refuse to provide informed consent
5. coagulopathy (platelet count \<50 ×103/uL, international normalized ration \>1.5）
6. severe cardiopulmonary dysfunction that cannot tolerate intravenous anesthesia
7. with history of mental disease
8. other medical conditions that are not suitable for EUS-FNA
Measurement of Activity Participation for Persons With Schizophrenia Living in the Community

The purpose of the study is to develop a questionnaire on community occupational participation for persons with schizophrenia living in the community. In the International Classification of Functioning, Disability, and Health (ICF) recently revised by World Health Organization, activity participation is recognized as an important indication of health-related status. From the perspective of occupational therapy, the researcher intends to investigate the experiences of occupational participation among schizophrenic patients living in the community, and to develop a measuring tool for occupational participation accordingly.

The development of the Community Occupational Participation Questionnaire will be based on the result of a qualitative research project which the researcher is carrying out at the moment. The resultant questionnaire will provide a quantitative measure of community occupational participation for persons with schizophrenia, as well as a measurement tool of activity participation for health-related research studies. Furthermore, it may provide valuable information to the development of community psychiatric services.

This current study will take one year. Tasks to be accomplished include: building item pool, examining content validity of each item, pilot testing, item analysis, norm establishment, and testing reliability and validity. Data will be collected in different areas of Taiwan, and will be analyzed with the following methods: content validity ratio, item-total correlation, Cronbach's alpha, and confirmatory factor analysis. The study will result in an occupational participation questionnaire with norm, validity and reliability.

First, the participants were informed the right and how to fill the self-report survey questionnare in. And then they began to complete the questionnare. After finishing it, the participants gave the questionnare back to the examinor and got a gift as a reward.

Eligibility Criteria:
Inclusion Criteria:

* person with Schizophrenia
* Must be able to read Chinese
* Majorly living in community
MRI and Microbiota Analysis in Constipation

The purpose of the study is to test how well magnetic resonance imaging (MRI) can measure whole gut transit time in people with constipation, and how readily it can detect a change in transit time induced by taking a dietary supplement with laxative effects.The investigators expect to demonstrate that ispaghula (psyllium) accelerates movement of matter through the intestinal tract.

The investigators will also assess whether a change in gut bacteria and the chemicals that they release can be detected.


Eligibility Criteria:
Inclusion Criteria:

* Meets Rome III Criteria for diagnosis of Functional Constipation5 on questionnaire (NB. Both those who do and do not meet IBS criteria will be eligible)
* At least one bowel motion per week while taking usual laxatives
* Able to give informed consent
* Aged 18 or older

Exclusion Criteria:

* History declared by the candidate of other pre-existing gastrointestinal disorder, including but not limited to:
* Inflammatory Bowel Disease
* Coeliac Disease diagnosed in the last year
* Pancreatitis
* Cancer of the gastrointestinal tract
* Any reported history of gastrointestinal resection (excluding appendicectomy or cholecystectomy)
* Presence of an intestinal stoma
* Pregnancy declared by candidate (no formal testing)
* Contraindications for MRI scanning i.e. metallic implants, pacemakers, history of metallic foreign body in eye(s) and penetrating eye injury
* Reported alcohol intake of \>28 units/ week with daily drinking
* Any use of a product containing ispaghula or psyllium in the 4 weeks prior to consent
* Unable to avoid use of dihydrocodeine or morphine during the study
* If taking other regular opiates such as codeine, fentanyl or Oxycodone, participants should be able to maintain a stable dose throughout the study
* Any reported history of hypersensitivity or significant adverse reaction to ispaghula, maltodextrin or bisacodyl
* Unable to stop drugs and other agents used primarily for their laxative effect, during periods of screening, washout, baseline and treatment (maximum 15 days - rescue medication will be provided).
* Antibiotic or prescribed probiotic treatment in the past 4 weeks
* Inability to lie flat or exceed scanner limits of weight \<120kg
* Poor understanding of English language
* Participation in any medical trials for the past 3 months
* Any condition where the candidate is likely to require a course of antibiotics in the next 3 months e.g. severe chronic respiratory disease, recurrent urinary tract infection, lower limb ulceration
* Judgement by the PI that the candidate who will be unable to comply with the full study protocol e.g. Diabetes, severe COPD

During the screening 2 weeks off laxatives

* No bowel motions recorded during screening period
* ≥3 complete spontaneous bowel motions (CSBMs - bowel motion with the feeling of complete evacuation, without the use of rescue therapy in the preceding 24 hours) per week
Canadian Humira Post Marketing Observational Epidemiological Study : Assessing Humira Real-life Effectiveness and Impact on HS Burden of Illness

This study assesses Humira's® real-life effectiveness in the management of dermatological manifestations of moderate to severe Hidradenitis Suppurativa (HS).


Eligibility Criteria:
Inclusion Criteria:

* Has a clinical diagnosis of moderate to severe HS according to the treating physician judgment
* Need a change in ongoing therapy for any reason, but not limited to inadequate response, intolerance, sub-optimal compliance, or patient preference. Patient will be approached to participate in the study after a decision to change patient's therapy for Humira® is made by the treating physician.
* Has provided written informed consent (Patient Authorization) for participation in the study

Exclusion Criteria:

* Is participating in a clinical interventional study
* Was treated with Humira®, or any other biologic agents for HS prior to baseline visit
* Has any other active skin disease or condition that, in the opinion of the treating physician, prohibits the patient from participating in the study or obscures the assessment of the treatment of HS
the Beijing Randomized Study Of Prostate Cancer Screening

BROPCS is a randomized trial study comparing the effectiveness of traditional systematic biopsies and bpMRI followed targeted biopsies with PSA \> 4ng/ml in initial screening.

The aim of BROPCS study is to explore a suitable prostate cancer screening model for Chinese population, which can increase the specificity in early detection of prostate cancer without decreasing the sensitivity of clinically significant prostate cancers, and can reduce prostate cancer-specific mortality.This study will use a cluster randomized controlled trial method with a total of approximately 30,000 participants. The subjects will be randomly assigned to a control group (about 20,000 people) and a screening group (about 10,000 people), and some basic information will be obtained through a questionnaire survey. The screening group will undergo initial prostate-specific antigen (PSA) screening, and high-risk subjects (PSA \> 4ng/ml) will be randomly assigned to two groups. The standard biopsy group will undergo traditional systematic biopsy, while the precision screening group will undergo further MRI examination and targeted fusion biopsy for those with positive MRI results.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy men aged 60-75 with a life expectancy of more than 10 years;
2. Residing continuously in the community for more than 3 years and not previously diagnosed with prostate cancer;
3. Willing to participate in this project.

Exclusion Criteria:

1. Previously diagnosed with prostate cancer;
2. Previously diagnosed with any malignant tumor within the past 5 years;
3. Used medication within the past 3 months that can affect PSA values, mainly finasteride, dutasteride, and ketoconazole;
4. Recently had acute prostatitis, acute urinary retention, or underwent transurethral procedures (such as urethral dilation, urinary catheterization, cystoscopy, etc.) within the past week;
5. Have other serious illnesses or cannot perform activities of daily living independently.
Treatment of Perirectal Fistula With Cutting Seton vs. Collagen Plug

The purpose of this study is to determine if the collagen plug method heals perirectal fistulae as well as the conventional seton method.

Traditional treatments for transsphincteric perirectal fistulae rely upon an immediate (fistulotomy) or delayed (seton) transsection of the sphincter muscle possibly resulting in fecal incontinence, take a long time to heal, and/or are associated with significant failure rates (ex. fibrin glue).

Newer treatment concepts such as the collagen plug do not physically interrupt the sphincter muscle, avoid and minimize the risk of fecal incontinence, and decrease the time to fistula healing. Exciting initial reports have confirmed the collagen plug's utility in treating perirectal fistulae, but a systematic scientific comparison is needed to validate the new, less invasive plug method.

The primary goal of this study is to show that the collagen plug heals transsphincteric perirectal fistulae as well as the conventional seton method.

Eligibility Criteria:
Inclusion Criteria:

1. Patients that are undergoing surgery for perirectal fistulae by the USC Colorectal Group
2. Patients that are older than 18 years of age and are able to understand and sign consent
3. Patients that are suitable candidates for either seton or collagen plug placement

Exclusion Criteria:

1. Preoperative patient exclusion factors:

   * Pregnant patients
   * Patients with a tumor-related fistula
   * Patients with known allergies to porcine products
   * Patients with known Crohn's disease
2. Intraoperative patient exclusion factors:

   * Patients with an active purulent infection (pus draining from the fistula tract or abscess associated with the fistula tract) at the time of surgery
   * Patients with a large diameter fistula (\>3mm)
   * Patients with a superficial fistula
   * Patients with a short fistula (\<1 cm in length)
Effect of Iron Deficiency Anemia on HBA1C in Patients With Diabetic Foot Ulcer Grade (1and2)

Diabetic foot ulcer is the commonest cause of severe limb ischemia in diabetes mellitus And development of anemia is an additional burden to the microvascular complications of diabetes

HBA1C is the predominant Hemoglobin found in HBA1 fraction and it constitutes 5% of total Hemoglobin in normal adults and up to 15%in patients with diabetes mellitus HBA1C is used to diagnose diabetes and to identify individuals that are at high risk for developing diabetes Iron deficiency anemia is one of the most prevalent form of malnutrition affect 1,62 billion people whish correspond to 24,8%of the world population Ferritin is the storage form of iron so it is found to be test for distinguishing those with iron deficiency anemia from those who are not iron deficient

Eligibility Criteria:
Inclusion Criteria:

* all diabetic patients with diabetic foot ulcer grade one and two above 18 year

Exclusion Criteria:

1. patients with anemia other than iron deficiency anemia
2. Patients on anticoagulants
3. patients with blood disease 4-patients below 18
Ametop - Friend and Foe A Prospective Study of the Incidence of Adverse Reactions With Ametop

Ametop was introduced into the formulary as it was deemed more efficacious for intravenous cannulation compared to EMLA. However, the incidences of adverse reactions seemed to be higher compared to other studies. This lead to a prospective observational study to look at the incidence and severity of skin reactions following routine clinical application of Ametop.

Ametop was introduced into the formulary as it was deemed more efficacious for intravenous cannulation compared to EMLA. After several critical incidences of adverse reactions that occurred with its application, a departmental audit was carried out to look at the incidence and severity reactions with its application as well as its outcome on intravenous cannulation. The findings of the departmental audit showed that the incidence of adverse reactions seemed to occur more commonly compared to other studies.

A prospective observational study was carried out to look at the incidence and severity of skin reactions following routine clinical application of Ametop.

This study aims to achieve the following:

1. Investigate the incidence and severity of adverse skin reactions following topical application of Ametop prior to intravenous cannulation
2. Assess the success rate of intravenous cannulation
3. Identify the possible risk factors associated with adverse skin reaction.

Eligibility Criteria:
Inclusion Criteria:

* All paediatric patients presenting for surgery from August 2014 to May 2015 who have had Ametop applied prior to intravenous cannulation.

Exclusion Criteria:

* Any patient who did not have Ametop applied or have an intravenous cannula in situ.
Investigation of Microbiome-Derived Metabolite Production in Response to a Mediterranean Diet

This project proposes to characterise the microbiome-derived metabolites produced upon ingestion of bioactive precursor-rich meals by healthy volunteers in order to investigate the relationship between gut microbiome composition and the nature of dietary metabolites production.

There is a large inter-individual variability in gut microbiome-derived metabolites production upon ingestion of similar meals. Since many of these microbiome-derived metabolites have enteric and systemic biological effects, these variabilities could in part account for the different responses to meals and diets.

This project thus aims to improve the understanding the relationship between gut microbiome composition and the nature of dietary metabolites produced from similar bioactive precursor-rich meals.

The investigators therefore propose to characterise the circulating microbiome-derived metabolite profiles in healthy individuals fed the same 2-day precursor-rich Mediterranean diet prior to and after a 2-week of habitual Canadian diet feeding.

Eligibility Criteria:
Inclusion Criteria:

* Men and women aged between 18 and 35 years
* Body mass index between 18.5 and 30 kg/m2
* General good health
* Computer and Internet access
* Basic understanding of written French

Exclusion Criteria:

* Intestinal pathologies including inflammatory bowel disease and gastrointestinal cancers
* Pregnant and/or breast-feeding women
* Alcohol consumption greater than 15 portions for men and 10 for women weekly
* Active tobacco usage
* Consumption of dietary supplements (e.g. multivitamins, omega-3, probiotics)
* Completion of a course of antibiotics in the past 3 months
* Regular use of anti-inflammatory drugs, or use in the past 3 months
* Important weight change (+/- 5 kg) in the past 6 months
* Allergies or food intolerances to ingredients present in trial diets
Comparison of Aerobic Exercise and Spinal Stabilization Exercises in Women With Primary Dysmenorrhea

The aim of the study is to compare the effects of aerobic exercise and spinal stabilization exercises in women with primary dysmenorrhea (PD) complaints.

PD is the cramping pain that comes before or during a period. Different exercise approaches have positive effects in PD. Comparing the effects of these exercise approaches is needed to determine the effects on PD.

Eligibility Criteria:
Inclusion Criteria:

Women with primary dysmenorrhea complaint according to the Primary Dysmenorrhea Consensus Guide, Over 18 years of age, Having a mean pain intensity of moderate and higher according to the Visual Analogue Scale in the last 6 months, Having a regular menstrual cycle (28±7 days), Volunteered to participate in the study.

Exclusion Criteria:

Having a pathological history and radiological findings pointing to secondary dysmenorrhea, Using oral contraceptives/antidepressants at least 6 months, Receiving hormone therapy, Undergoing pelvic surgery, Pregnant, Giving birth, Using an intrauterine device, Having neurological, orthopedic and/or rheumatological diseases Having a history of ischemic heart disease (recently myocardial infarction, angina pectoralis, uncontrolled hypertension, etc.), Having a psychiatric disease, Having a history of malignancy
Progenitor Cells in Human Esophagus

The purpose of this study is to better understand how esophageal cells change with age.

The researchers will collect information from the patient's medical record and collect esophageal tissue at the time of the patient's surgery in excess of clinical diagnosis (i.e. tissue that would otherwise be discarded). There will be no patient contact after the patient's surgery. The researchers will analyze sections of adult esophagus tissue for the presence of CD34+ sox2+ progenitor cells to determine the number of progenitors present at a particular age. The researchers will also examine sections of different portions of the esophagus, to determine whether certain sections contain more progenitors, and thus perhaps a greater ability to regenerate, than others.

This study involves testing DNA and patients will not be notified of the genetic test results and the results will not be put into their medical record. Patients will be asked to give consent to have any remaining esophageal tissue used for future studies of esophageal disease at Mayo Clinic, learn about, prevent, or treat any other health problems and give their sample and related information to researchers at other institutions.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years old
* Esophagus surgery at Mayo Clinic

Exclusion Criteria:

* \<18 years old
Optimizing Growth in Infants Receiving Modified Fat Breast Milk for the Treatment of Chylothorax

Breast milk is the reference normative standard for infant feeding. When an infant is diagnosed with chylothorax, provision of breast milk must be temporarily discontinued due to the presence of long chain triglycerides (LCT) that contribute to persistent chylous drainage. In its place, the infant is prescribed a therapeutic formula high in medium chain triglycerides (MCT) as treatment for chylothorax. Families and health care providers are interested in using breast milk, in a modified fat form, as treatment for chylothorax instead. This study will assess growth in infants receiving one of two nutrient enriched modified fat breast milk (MFBM) treatments for chylothorax. If either of the proposed nutrient enrichment methods support growth, MFBM will become a standard chylothorax treatment option for infants at SickKids.


Eligibility Criteria:
Inclusion Criteria:

* confirmed diagnosis of chylothorax following cardiothoracic surgery
* previously receiving a minimum of 50% of feeds from breast milk 3 days prior to surgical procedure
* parents/caregivers would like to continue to provide breast milk during chylothorax treatment

Exclusion Criteria:

* diagnoses of chylothorax classified as either congenital, obstructive, or traumatic not following cardiothoracic surgery
* patient has a chromosomal anomaly that affects growth (i.e. Trisomy 21, Trisomy 18 etc.)
* patient receiving less than 50% of feeds from breast milk (or mother does not have intention to provide breast milk)
* neither parent/caregiver/family member able to communicate effectively in English