cyrilzakka/clinical-trials huggingface dataset:
Comparison of Metformin and Repaglinide Monotherapy in the Treatment of New Onset Type 2 Diabetes Mellitus in China

The prevalence of diabetes is up to 11.6% according to the data released in 2013 by the China Noncommunicable Disease Surveillance Group.Less than 40% of all diagnosed-diabetes were well controlled.Among all kinds of antidiabetic medications, metformin is recommended as the first-line antihyperglycemic management for type 2 diabetes. Insulin secretagogue,repaglinide is still one of the most widely used antidiabetic medications in China. However, there were few studies comparing the effects of these two medications on glycaemic control in Chinese patients with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* All participants with type 2 diabetes, diagnosed by World Health Organization criteria, were recruited from outpatient of the Endocrinology Department in Shanghai Renji Hospital

Exclusion Criteria:

* Patients who had a history of coronary heart disease, abnormal renal function, active liver disease, chronic metabolic acidosis (including diabetic ketoacidosis), or severe chronic gastrointestinal disease.
An Investigational Drug Study in Patients With Elevated Cholesterol and Coronary Heart Disease (0653-804)(COMPLETED)

The purpose of this study is to investigate additional cholesterol lowering effects in patients with coronary heart disease by giving an investigational drug with a patient's current approved cholesterol lowering medication.

The duration of treatment is 10 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Patients with elevated cholesterol and coronary heart disease

Exclusion Criteria:

* Patients whose cholesterol levels measure within acceptable ranges as specified by the study requirements
Remifentanil Versus Propofol for TCI Sedation of Patients Undergoing Gastrointestinal Endoscopic Procedures

The purpose of this study was to compare remifentanil and propofol for sedation of patients during endoscopic gastrointestinal procedures.

The administration of sedation with target controlled infusion (TCI) systems could offer a safe alternative for the management of discomfort of patients undergoing endoscopic gastrointestinal procedures. However, what medication from those available for TCI would be the most appropriate is not known.

Sixty-nine patients requiring a gastrointestinal endoscopic procedure were randomly assigned to receive a TCI effect site (e) of remifentanil (n=30) or propofol (n=39). The primary outcome was patient satisfaction. Secondary outcomes included gastroenterologist satisfaction, the proportion of adverse events between the two groups were compared (occurrence of cardiac arrhythmias, mild respiratory depression, major respiratory depression, bradycardia, hypotension, pain, nausea or vomiting, and lack of amnesia), and the level of consciousness.

Eligibility Criteria:
Inclusion Criteria:

* Patient undergoing elective higher, lower or mixed gastrointestinal endoscopy at Hospital de San Jose, Bogota, between January and December 2010.
* Be between 18 and 70 years old.
* American Society of Anesthesiology Physical Status classification between 1 and 3.
* Provide written informed consent.

Exclusion Criteria:

* Patients with difficult airway indicators.
* Pregnant women.
* Patients with chronic pain.
* Chronic opioid or benzodiazepine users (\>3 months).
* Allergy history to remifentanil or propofol or eggs.
* Psychoactive drug users.
* Smokers (\> 5 cigarettes per day in the previous 3 months).
* Body mass index \> 30.
Development of a Targeted Patient Portal Intervention to Improve Depression Treatment Adherence and Outcomes

The purpose of this research study is to learn how best to use patient portals to help improve the treatment of mood disorders.

This study is being done in 3 phases. First 2 phases were observational with total enrollment of 300 subjects. The final 3rd phase is interventional and we are anticipating to enroll 50 subjects. It is described below.

Patients being treated for depressive symptoms at the University of Iowa, Department of Psychiatry are invited to participate. Participants will complete a remote (phone or video) visit. After being informed about the study and potential risks, those who consent to being in the study will be assigned to one of two groups. They will complete an online survey and receive some basic training on patient portals. After the visit. both groups will be followed for 6 months. Depending on their group assignment, they will complete:

* two to five phone calls with a study team member and
* two to five online questionnaires

Eligibility Criteria:
Inclusion Criteria:

* English speaking,
* PHQ-9 score of 10 or higher (questions 1-8 only),
* Taking medication for depressive symptoms,
* 1 or more appointments scheduled or planned with University of Iowa psychiatry provider in next 6 months,
* Home computer w/internet access,
* MyChart (University of Iowa Healthcare's patient portal) account/MyChart enrollment

Exclusion Criteria:

* Psychotic disorder/symptoms,
* Current substance use disorders (other than alcohol, tobacco, marijuana),
* Active suicidal ideation within past 1 year,
* Cognitive impairment
The Effect of CoQ10 Administration on Hemodialysis Patients

The purpose of this study is to examine whether CoQ10 administration is effective as an antioxidant in hemodialysis patients.

Oxidative stress has been recognized as a potential risk factor for such complications as atherosclerosis in hemodialysis patients. This study investigates whether CoQ10 administration is effective for protecting oxidative stress in hemodialysis patients. The subjects were recruited from day-time hemodialysis patients in Iwata City Hospital. 100 mg CoQ10 was administered every HD for 6 months. Several oxidative and antioxidative markers were measured in plasma at pre, 1, 3, 6 months and after washout.

Eligibility Criteria:
Inclusion Criteria:

* hemodialysis for at least 6 months

Exclusion Criteria:

* none
Effects of Karate in Adolescents With Down Syndrome

This randomized control study will investigate the health outcomes of adolescents with Down Syndrome who participate in a karate class as measured by ALPHA fitness testing and various PROMIS parent proxy questionnaires to assess participants mobility, physical activity, and overall affect.

Adolescents with Down syndrome suffer from a set of health problems including heart disease, sleep disturbances, and obesity. Their decreased cardiovascular fitness and exercise capacity limits their ability to perform activities of daily living. Exercise interventions in this population of children have been shown to improve muscle strength, balance, and cardiovascular fitness. Prior research has helped better define physical activity barriers in this population which include: requiring parental supervision, lack of accessible programs, seasonal activities and reduced physical skills of the child. Karate is an indoor activity that can be performed at different skill levels without parental involvement. The investigators hypothesize that adolescents with Down syndrome who participate in karate will show improved health outcomes compared to those who did not participate. Furthermore, the investigators hypothesize that the majority of participants will continue the activity outside of the research window. This randomized controlled trial will enroll 30 adolescents with Down syndrome. Participants will be randomly assigned to a 3 month karate program or the control group with no intervention. Measurements are taken at baseline, 3 months, and 6 months using validated ALPHA fitness testing and in addition parents will complete PROMIS questionnaires to assess overall participant's activity level, mobility, and generalized affect. An independent statistician will analyze the groups. This research will help physicians provide adolescents with Down syndrome appropriate recommendations for an individualized physical activity regimen that does not have similar limitations to other exercise programs.

Eligibility Criteria:
Inclusion Criteria:

* males \& females with a diagnosis of down syndrome
* Ability to participate in 2 hours of exercise per week
* No involvement in formal martial arts classes over the past 3 months

Exclusion Criteria:

* Behavior problems that would prevent them from participating in organized classes
* Health problems that preclude them from participating in moderate physical activity programs (e.g. uncontrolled seizures)
* No Co-existing diagnosis (e.g. ASD)
An ACT-enhanced Weight Management and Fitness Program for Navy Personnel

The proposed study is a cohort-randomized controlled trial of Acceptance and Commitment Therapy-enhanced ShipShape (ACT+SS) compared to the standard ShipShape-only program, for overweight or obese Navy personnel. As a result of COVID-19, this study is now being conducted virtually.

The proposed study is a cohort-randomized controlled trial of ACT-enhanced SS (ACT+SS) compared to the SS-only program. Cohorts of Navy personnel who are failing or at risk of failing the body composition assessment (BCA) or who are overweight/obese will be randomized to receive 8 weekly ACT+SS intervention groups or 8 weekly SS-only intervention groups. The scientific aims are to: 1) determine the effectiveness of ACT+SS compared to the SS-only program; 2) examine psychological flexibility as a mechanism underlying intervention response; and 3) explore potential moderators of intervention response. The primary outcome is weight loss.

Secondary outcomes include BMI, body fat %, indices of physical activity, problem eating, functioning and quality of life, emotional functioning and indices of psychological flexibility, measured at baseline, mid- and post-intervention, and 3- and 6-month follow-up and self- reported BCA status at 6-month follow-up. The investigators have purposefully designed a cohort-randomized trial with interventions that are pragmatically implemented in a real-life military setting, and outcomes that are immediately relevant to service members and leadership. The cohort randomization is essential to the feasibility and acceptability of the research in this setting. The military-relevant and generalizable findings are more likely to have impact within the military. SS provides an ideal comparison arm that is the current standard of practice in the Navy. Integrating ACT with SS in this setting overcomes many of the logistical, practical, chain-of-command, and other challenges that have typically impeded research in the military. The investigators have thoughtfully selected primary and secondary outcomes that are theoretically linked, and additional assessments that are empirically-based and will allow better understanding of mediators and moderators of intervention response in Navy personnel. Due to Covid-19 we have adapted the interventions to be administered virtually.

Eligibility Criteria:
Inclusion Criteria:

* Navy Personnel who are overweight/obese or have failed or are at risk of failing the BCA
* 18-69 years of age
* Willingness to participate in the study

Exclusion Criteria:

* Any physical limitations (injuries, pregnancy, etc.) that preclude engagement in the physical fitness activities
Gastrointestinal And Metabolic Effects From a Prebiotic, Lifting, and Aerobic iNtervention

This study aims to determine the independent and combined effects of prebiotic fiber supplementation and exercise on the gut microbiome and human health.


Eligibility Criteria:
Inclusion Criteria:

* BMI 18.5-45 kg/m2
* Without physician diagnosed gastrointestinal or metabolic diseases
* Sedentary (\< 30 minutes of moderate or high intensity exercise per week OR \< 20 aggregate Godin-Shepard Leisure Time Physical Activity Questionnaire (GSLTQ; GodinLeisure) score)
* Fully vaccinated against COVID-19

Exclusion Criteria:

* Fasting blood glucose \>126 mg/dL
* Blood pressure \>160/100 mm Hg
* Physician diagnosed metabolic or gastrointestinal diseases or constipation
* Heart conditions that may pose risk during exercise
* Taking oral hypoglycemic agents or insulin
* Pregnant, breastfeeding or postmenopausal
* Smoke or consume \> 2 alcoholic beverages/day, abuse drugs
* Have had \> 5% weight change in the past month or \> 10% change in the past year
* Have had any form of bariatric surgery or gallbladder removal
* Have taken antibiotics during the previous 3 months
* Unable to consume the experimental fiber
A Phase 2 Study With Enzastaurin Plus Chemotherapy or Placebo Plus Chemotherapy for Prostate Cancer Patients

The purpose of the study is to compare the response rates for prostate cancer patients taking chemotherapy plus enzastaurin versus chemotherapy plus placebo.


Eligibility Criteria:
Inclusion Criteria:

* You are at least 18 years old.
* You live close enough to the doctor's office to attend all of your required visits.
* You have not been treated with chemotherapy for your prostate cancer.
* Your organs must be functioning properly.

Exclusion Criteria:

* You are unable to swallow pills.
* You have another serious illness besides your prostate cancer.
* You have taken another experimental drug within the last 30 days.
* You have a serious heart condition.
* You are receiving another anti-cancer therapy.
Screening for Asymptomatic Portal Vein Thrombosis and Portal Hypertension in Patients With Philadelphia Negative Myeloproliferative Neoplasms

This study involves screening for portal vein thrombosis and portal hypertension in patients with Philadelphia negative myeloproliferative neoplasms (MPNs). These include polycythemia vera (PV), essential thrombocythemia (ET), and myelofibrosis.

Portal vein thrombosis and portal hypertension are serious complications that are often seen in myeloproliferative patients. These complications are usually diagnosed when patients become symptomatic, and are often already at an advanced stage. They can further progress to cause non-reversible damage to the liver, also called cirrhosis of the liver. As a result of this, patients often accumulate fluid in the abdomen which is ascites; and can develop swelling of veins in the lining of the esophagus known as varices. If untreated, varices have the risk of rupturing resulting in life-threatening bleeding. When diagnosed at an advanced stage, the treatment is usually supportive therapy and there are no treatments available at present which can reverse these conditions.

This study is looking at screening for these two conditions using Doppler ultrasound and upper gastrointestinal endoscopy.


Eligibility Criteria:
Inclusion Criteria:

* One of the three classical Philadelphia negative myeloproliferative neoplasms (polycythemia vera (PV), essential thrombocythemia (ET) and myelofibrosis (MF)) diagnosed according to WHO or International working group-Myelofibrosis research and treatment (IWG-MRT) criteria
* Palpable spleen length greater than 5 cm below the costal margin in MF (including primary MF or post-polycythemia vera MF (PPV-MF) post-polycythemia vera ET (PPV-ET)) or palpable spleen of any size in patients with PV or ET.
* Ability to understand and willing to sign a written consent form.
* Age 18 years or older at time of consent.

Exclusion criteria:

* Known history of portal vein thrombosis
* Known history of Budd-chairi syndrome
* Known history of oesophageal varices
* Known history of cirrhosis from any cause
* Known history of active bleeding
To Determine the Efficacy of the TwinGuard in Oxygen Delivery During and Post Endoscopic Procedure

A comparative study which compares the end-tidal carbon dioxide and oxygen saturation levels of patients during endoscopy which have used either the new oral-nasal oxygenating device (TwinGuard), or a standard bite block plus nasal cannulae using an equivalent flow rate of oxygen.

Hypoxia is common during endoscopy. Following sedation induction, oxygen saturation falls moderately in most patients, whilst some drop to unacceptable levels. To monitor such changes endoscopic practices routinely use oximeters and capnography.

TwinGuard is an all-in-one device which incorporates a bite block with the functionality of nasal cannula as well as monitoring expired air (carbon dioxide)

Eligibility Criteria:
Inclusion Criteria:

* Provided written fully informed consent as per protocol
* No clinical evidence of significant respiratory conditions
* Fasted for 6 hours prior to enrolment as per standard clinical practice for panendoscopy

Exclusion Criteria:

* Patients suffering from cardio respiratory disease, moderate to severe asthma, lung and heart disease
* Patients who have a history of drug or alcohol abuse
Effectiveness of CRD-740 in Heart Failure

This is a study evaluating the effectiveness of CRD-740 in patients with either Heart Failure with Reduced Ejection Fraction (HFrEF) or Heart Failure with Preserved Ejection Fraction (HFpEF) after 12 weeks of treatment. The primary objective in Part A is to assess the effect of CRD-740 compared to placebo in plasma cGMP at Week 4 in HFrEF.

Part B of the study was not conducted in favor of redesigned new studies.


Eligibility Criteria:
Inclusion Criteria:

1. Males or Females ≥18 years of age, at screening.
2. Diagnosis of clinical heart failure syndrome, New York Heart Association functional class II - III for at least 6 months prior to screening
3. For Part A:

   * Ejection Fraction ≤40% by echocardiography at screening.
   * NT-proBNP level ≥600 pg/ml at screening. Subjects with atrial fibrillation or flutter at screening are required to have an NT-proBNP level of ≥1000 pg/mL at screening.

5. Stable doses of guideline-directed heart failure therapy for a minimum of 4 weeks prior to screening that has been individually optimized according to standard practice guidelines and no addition of guideline-directed heart failure therapy within 3 months of screening.

Exclusion Criteria:

2. Recent HF exacerbation defined by hospitalization or requirement for intravenous diuretics within 60 days of screening.

3. Subjects with planned interventions (e.g., percutaneous coronary intervention, devices) etc. occurring during their involvement in this study.

4. Acute coronary syndrome, stroke, transient ischemic attack, cardiac, carotid or other major cardiovascular surgery or carotid angioplasty within 60 days of screening.

5. Subjects with clinical suspicion of infiltrative cardiomyopathy (e.g., amyloid, sarcoid), hypertrophic cardiomyopathy (obstructive or non-obstructive), or HF secondary to severe valvular disease, active myocarditis, active pericarditis, or clinically significant congenital heart disease.

6. Prior or planned orthotopic heart transplantation.

7. Presence of or plan for mechanical circulatory support.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Fast Versus Slow Application of Vulsellum During Intrauterine Device Insertion

intrauterine device insertion requires use a vulsellum to stabilize the cervix. Patient's often complain that its placement is one of the most uncomfortable parts of this procedure


Eligibility Criteria:
Inclusion Criteria:

* Women not taken analgesics or anxiolytics in the 24 hours prior insertion
* Women not taken misoprostol prior to intrauterine device insertion
* Women who will accept to participate in the study

Exclusion Criteria:

Any contraindication to intrauterine device placement
Study to Evaluate the Safety and Effectiveness of MRgFUS Compared With Myomectomy for the Treatment of Uterine Fibroids

The objective of this trial is to evaluate the safety and efficacy of ExAblate for the treatment of uterine fibroids.

Women, seeking treatment for symptomatic uterine leiomyomata will be eligible for the study.Women who agree to participate will sign an informed consent and will be randomized to ExAblate treatment or myomectomy.

All patients will be followed through the 36 month visit. Follow-up visits/telephone calls will be completed at 1 week, 2 weeks, 6 weeks, 3 months, 6, 12, 18, 24 and 36 months post treatment.

Patients will be evaluated by assessing their overall physical and mental health as well as for device/procedure related adverse events.


Eligibility Criteria:
Inclusion Criteria:

1. Women age 18 or older
2. Symptomatic uterine fibroids, defined as those resulting in scores of 21 or higher, based on patient responses to questions 1-8 (raw score) of the Uterine Fibroid Symptom and Health-Related Quality of Life Questionnaire (UFS-QOL).
3. Women who have given written informed consent
4. Women who are able and willing to attend all study visits
5. Patient is pre or peri-menopausal (within 12 months of last menstrual period)
6. Able to communicate sensations during the ExAblate procedure
7. Uterine fibroids, which are device accessible
8. Fibroid(s) clearly visible on non-contrast MRI.
9. Fibroid(s) enhances on MR contrast imaging

Exclusion Criteria:

1. Women currently pregnant
2. Uterine size \> 24 cm W/O the cervix
3. More than 4 clinically significant fibroids (per MRI)
4. Prior myomectomy, UAE
5. Allergy to either gadolinium or iodinated contrast
6. Implanted metallic device prohibiting MRI
7. Severe claustrophobia
8. Active pelvic infection
9. Current use of intrauterine contraceptive device
10. Unstable medical conditions requiring additional monitoring during the procedure
11. Bleeding diathesis requiring medical treatment
12. Imaging suggestive of malignant disease of uterus, ovary, or cervix
13. Imaging and suggestive of adenomyosis.
14. Pedunculated submucosal or pedunculated subserosal myoma
15. Size and weight which prohibits subject from fitting in MRI device
16. Unavoidable, scarring, skin folds or irregularity, bowel, pubic bone, IUD, surgical clips or hard implants in the beam path.
17. Hyper intense fibroid relatively to the uterus muscle
18. Women with ovarian dermoid cyst anywhere in the treatment path
Rehabilitation of Facial Emotion Recognition in Alzheimer's Disease

This study aims to evaluate impacts of an emotion recognition rehabilitation program, named Training of Affect Recognition, on social cognition abilities in Alzheimer's disease (AD). In addition, we hypothesis that the effect of this rehabilitation will also evolve gaze strategies, behavioral disorders, and the caregiver's burden.

It is commonly admitted that social cognition impairment, like deficit in facial emotion recognition or misinterpretation of others' intentions (Theory of Mind), are associated with social behavior disorders.

This kind of disorders are observed in Fronto-Temporal Dementia, Alzheimer's Dementia (AD) and Parkinson's Disease, with severe deficits in FTD and lighter deficits in AD and PD. One explanation is that patients apply inappropriate visual exploration strategies to decode emotions and intentions of others.

Our study aims to evaluate impacts of an emotion recognition rehabilitation program, named Training of Affect Recognition, on social cognition abilities (facial emotion recognition (FER) and theory of mind (ToM)) in Alzheimer's disease (AD). In addition, we hypothesis that the effect of this rehabilitation will also evolve gaze strategies, behavioral disorders, and the caregiver's burden.

Eligibility Criteria:
Inclusion Criteria:

* AD diagnosed according to l'IWG-2 (Dubois \& al. 2014) criteria,
* Mini-Mental State (MMS-E) ≥15
* Subject accompanied by a family caregiver and whose participation in a cognitive stimulation workshop was recommended in Memory Centre of the RAINIER Centre (Princesses Grace Hospital - Monaco)
* Written informed consent signed by patient and family caregiver.

Exclusion Criteria:

* General anaesthesia within 3 months.
* Ophthalmological or neurological problems preventing a video-oculography examination.
* Oculomotor disorders such as "fixation disorders" or "ocular tracking disorders".
* Cognitive disorders of the type: visual agnosia, visuo-spatial disorder, visuo-perceptual disorder or aphasia.
* History of bipolar disorder or schizophrenia
* History of alcohol abuse.