cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of the GTS400 Stent in Conjunction With Cataract

To evaluate the safety and efficacy of the Glaukos Trabecular Micro-Bypass Stent Model GTS400 in conjunction with cataract surgery, compared to cataract surgery only, in subjects with mild to moderate open angle glaucoma.

The objective of this trial is to evaluate the safety and efficacy of the Glaukos Trabecular Micro-Bypass Stent Model GTS400 (hereinafter referred to as GTS400) in combination with cataract surgery, compared to cataract surgery only, in subjects with mild to moderate primary open-angle glaucoma. This is a prospective, randomized, concurrently controlled, parallel groups, multicenter clinical investigation of the GTS400. Treatment will consist of either implantation of GTS400 stents in the study eye in conjunction with cataract surgery (Group 1, Investigational Group), or cataract surgery only (Group 2, Control Group). Clinical data through 12 months postoperative will form the basis of a pre-market approval (PMA) submission. Subjects will be followed for two years postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* Mild to moderate Open-Angle Glaucoma with specific criteria, in need of cataract surgery
* Subject willing to attend scheduled follow-up exams for two years postoperatively, Subject willing to provide written informed consent on the Institutional Review Board approved Informed Consent Form

Exclusion Criteria:

Not meeting inclusion criteria
Empa PASS on Urinary Tract Malignancies

The aim of the study is to assess the risk of urinary tract malignancies in patients initiating empagliflozin (free or fixed dose combination) compared to patients initiating a dipeptidyl peptidase-4 (DPP-4) inhibitor.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of type 2 diabetes
* Age over 18 years at index date
* At least 1 year of membership in the medication database prior to index date

Exclusion Criteria:

* Patients with any cancer (excluding non-melanoma skin cancer) recorded at any time prior to the index date (i.e. during the available look-back time)
* Diagnosis of type 1 diabetes or other specific non-type 2 diabetes
* Use of any SGLT-2 inhibitor or any DPP-4 inhibitor (including free and fixed-dose combinations) recorded at any time prior to index date (i.e. during the available look-back time).
* Use of fixed-dose combinations of SGLT-2 inhibitors with DPP-4 inhibitors
* Diagnosis of end stage renal disease or receipt of renal dialysis recorded at any time prior to index date (i.e. during the available look-back time)
Healthy Approach to weIght Management and Food in Eating Disorders (HAPIFED)

The investigators have developed a new integrated therapy, namely a Healthy Approach to weIght management and Food in Eating Disorders (HAPIFED). HAPIFED is an enhanced behavioral weight loss therapy integrated with CBT for the management of EDs. HAPIFED uses CBT to treat ED behaviors and body image distress, whilst simultaneously emphasize a healthy lifestyle, the role of food and physical activity in mood regulation, and revised but clinically meaningful goals for weight loss. The investigators propose a randomized controlled trial (RCT) that will compare HAPIFED to CBT-E in people with obesity and either BN or BED. The two main aims will be to reduce symptoms of ED and to improve weight management. The RCT will be conducted in Sydney and in São Paulo with a one year follow-up.

In sum, a new approach in management of the increasing numbers of obese people with BN and BED is needed. The investigators propose a RCT that will compare a novel therapy HAPIFED with the current 'gold-standard' trans diagnostic treatment, CBT-E. HAPIFED has been developed by the CIs and is based on recent developments in psychological approaches to obesity in general (as highlighted in Casazza et al.'s (2013) paper on "Myths, presumptions and facts about obesity") and in people with co-morbid obesity and BN or BED. Unlike CBT-E, it allows reduced energy intake and education around specific food choices - a necessary element in weight loss.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of threshold or subthreshold for Bulimia Nervosa or Binge Eating Disorder (DSM-5/ICD-11)
* BMI between ≥ 27 and \< 40

Exclusion Criteria:

* Diagnosis of psychosis, bipolar disorder or substance abuse dependence and/or a high level of suicide risk.
* Use of weight loss medication or medications that interfere with appetite.
* Cushing or Prader-Willi syndromes
* History of bariatric surgery
* Patients who are already in treatment
Study Immunogenicity and Safety of 13-valent Pneumococcal Conjugate Vaccine

This study will assess the Immunogenicity and safety of 13-valent Pneumococcal Conjugate Vaccine compared with 23-valent Pneumococcal Polysaccharide Vaccine. All participants should be naïve of Pneumococcal vaccine.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Male and Female adults over 50 years of age at screening.
* The subject who understand the requirements of the study and voluntarily consent to participate in the study.
* The subject willing to use birth control measures for the entire study duration and negative urine hCG(Human Chorionic Gonadotrophin) test at screening for women presumed to be of reproductive potential.

Exclusion Criteria:

* Known hypersensitivity to any components of the pneumococcal vaccine
* Any confirmed or suspected immunosuppressive or immunodeficient conditions including leukemia, multiple myeloma, lympoma, Hodgkin's disease, etc.
* History of autoimmune disease including multiple sclerosis(MS), lupus, polymyositis, dermatomyositis, Hashmoto's thyroiditis, Sjogren's syndrome, rheumatoid arthritis
* Functional or anatomic asplenia
* Coagulation disorder contraindicating IM(intramuscular) vaccination
* Use of any immunosuppressive therapies within the preceding 3 months including anti-cancer chemotherapies or radiation therapies and medication such as cyclophosphamide, 6-mercaptourine, azathioprine, methotrexate, steroids, cyclosporine A, rapamycin, leflunomide, TNF-α antagonist (For corticosteroids, this will mean prednisone, or equivalent dose of ≥ 15mg/day. Inhaled and topical steroids are allowed.)
* Serious chronic disorders including metastatic malignancy, severe chronic obstructive pulmonary disease requiring supplemental oxygen, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, impaired immune function.
* Any licensed vaccine(not including diphtheria toxoid) administered within the 1 month prior to receipt of study vaccine or is scheduled to receive any other licensed vaccine(not including diphtheria toxoid) within 1 month following receipt of study vaccine.
* Subject has received diphtheria toxoid within 6 months prior to receipt of study vaccine or planned to receive diphtheria toxoid during full period of the study.
Resistance Under the Microscope

The purpose of this study is to determine whether lorazepam, which is used to lower preoperative anxiety, also improves postoperative recovery.

This study data will also be used for further research aiming to identify vulnerable patients in the day-case surgery setting.

Since the early 1980s, the investigators have seen a shift towards day-case surgery. Before surgery, many patients have negative feelings about the surgical procedure. These anxieties have various negative effects. To reduce this resistance preoperative administration of an anxiolytic drug is administered, typically a benzodiazepine. The investigators know that benzodiazepines are effective in reducing anxiety, but up to now there is nog good scientific evidence about the effectiveness of lorazepam on the quality of recovery in day-case surgery patients.

The ultimate goal of our research project is to identify patients who would benefit from preoperative benzodiazepine administration and who not. Identification would substantially contribute to optimal medical decision making.

Eligibility Criteria:
Inclusion Criteria:

* patients \> 18 years admitted to the Day-Case Surgery Department Erasmus MC

Exclusion Criteria:

* insufficient command of the Dutch language
* ophthalmology surgery
* Extracorporeal Shock Wave Lithotripsy (ESWL)-, Gastrointestinal endoscopic intervention, Botox-, Abortion and Pain treatment
* Use of psychopharmaceuticals
* Contra-indication of lorazepam use
Mobile App for Latinx Hazardous Drinkers With Clinical Anxiety

The purpose of this study is to develop and examine a culturally adapted, brief, integrated, Spanish language mobile health application for the Android platform, optimized to deliver a personalized feedback intervention (PFI) designed to enhance knowledge regarding adverse anxiety-alcohol interrelations, increase motivation and intention to reduce hazardous drinking, and reduce positive attitudes and intention regarding anxiety-related alcohol use among Latinx hazardous drinkers with clinical anxiety.

Investigators will develop a culturally adapted, brief, single-session, Spanish language, PFI delivered via a mobile health application for the Android platform through an iterative approach using expert input and focus groups. Next, Latinx hazardous drinkers with clinical anxiety will assess program navigation and conduct usability testing. Finally, Latinx hazardous drinkers with clinical anxiety will be recruited to complete the final prototype of the mobile health application in order to evaluate the feasibility, acceptability, and initial effects. Initial screening will be conducted via telephone; baseline and post-treatment data will be collected in-person; and 1-week, 1-month, and 3-months follow-up data will be collected remotely.

Eligibility Criteria:
Inclusion Criteria:

* 21 years of age or older
* self-identified as Latinx or Hispanic
* fluent in Spanish
* current hazardous drinking pattern
* current clinical anxiety
* able to provide written, informed consent
* owning an Android smartphone

Exclusion Criteria:

* currently involved in alcohol or other substance use program
* concurrent use of medication for anxiety or depression
* current engagement in psychotherapy for anxiety or depression
Metabolic Changes Induced by NMN in Healthy Subjects With Acute Binge Drink

The goal of this double-blinded, randomized, crossover trial is to investigate the effects of NMN supplementation on liver function, liver fat content and lipid metabolism in healthy young subjects with acute binge drink. The main questions it aims to answer are:

1. if NMN administration could accelerate alcohol metabolism and alleviate hangover symptom;
2. if NMN administration could alleviate alcohol-induced liver injury and hepatic steatosis.

The goal of this double-blinded, randomized, crossover trial is to investigate the effects of NMN supplementation on liver function, liver fat content and lipid metabolism in healthy young subjects with acute binge drink. The main questions it aims to answer are:

1. if NMN administration could accelerate alcohol metabolism and alleviate hangover symptom;
2. if NMN administration could alleviate alcohol-induced liver injury and hepatic steatosis.

Participants will be randomized into two groups (n=20), and take 4 NMN capsules (250mg/capsule) or 4 placebo capsules (maltodextrin), respectively. 15 minutes later, they are successively provided with same breakfast and then vodka with a dose of 1g/kg body weight. Venous blood are collected at 0h, 1h, 2h, 3h, 4h, 8h, 12h and 24h from each subject, respectively. In addition, nuclear magnetic resonance imaging (MRI) are taken at 0h, 4h and 24h after alcohol intake. After a 7-day washout period, volunteers are crossed over to another alternative group to receive the corresponding capsules and the test protocol repeats twice.

Eligibility Criteria:
1. Inclusion Criteria:

   a. Sign informed consent
2. Exclusion Criteria:

   1. Neurological disorders
   2. Alcohol allergy
   3. Alcohol addiction
   4. Gastrointestinal diseases
   5. Liver, kidney, cardiovascular or systemic diseases
   6. Antibiotics were administered within 2 weeks prior to the trial
   7. Participants who ate a vegetarian diet
   8. Unable to use a smartphone or computer with Internet access
   9. Participate in another intervention study
Moderate Intensity Intermittent Walking in Postmenopausal Women

The goal of this clinical trial is to investigate the impact of a walking training intervention program on liver enzymes and selected inflammatory markers in postmenopausal women with obesity. The main question it aims to answer is:

Does walking training reduce the risk of liver disease by modulating hepatic-enzymes and selected inflammatory markers? Researchers will compare walking training intervention (designed to the experimental group) to non-training intervention (designed to the control group) to see if the training program works to improve liver health in obese postmenopausal women.

Participants in the experimental (training) group will: underwent a moderate intensity intermittent walking training (MIWT) at 60% to 80% of the 6-min-walking-test distance, four times a week of 60 min/session.

Participants in control group will : not perform any physical training and maintain their usual daily activities.

Postmenopausal obesity is an important public health problem accompanied by increased systemic inflammation that escalates the risk of liver disease. Exercise improved inflammatory and hepatic function. Moderate-intensity intermittent-walking-training (MIWT) is the most feasible for obese-postmenopausal-women. This study aimed to investigate whether MIWT could reduce the risk by modulating hepatic-enzymes and selected inflammatory markers. Thirty-six sedentary obese postmenopausal women (mean age 55.7±3.5) were randomly divided into two groups: training group (TG, n=18) and control group (CG, n=18). The TG underwent a MIWT at 60% to 80% of the 6-min-walking-test distance, four times a week of 60 min/session. Body composition, hepatic (alanine-transaminase (ALT), aspartate-transaminase (AST), alkaline-phosphatase, gamma-glutamyl-transferase (GGT) and serum-bilirubin\] and inflammatory markers \[C-reactive-protein (CRP), and erythrocyte-sedimentation-rate (ESR)) were evaluated at baseline and after 10-week of protocol.

Eligibility Criteria:
Inclusion Criteria:

Women included are:

* Postmenopausal (≥1 year of amenorrhea).
* Obese (body mass index (BMI) ≥30 kg/m2).
* Sedentary (\<120 min/week of low to moderate intensity physical activity at during the past 6 months).
* Aged 50 to 60 years.

Exclusion Criteria:

* Suffering from any cardiovascular/renal/pulmonary/metabolic disease.
* Being under menopausal hormone therapy.
* Presenting any orthopedic limitations interfering the ability to perform the study intervention.
CSII Pilot in Adolescents With Type 2 Diabetes

This feasibility pilot is intended to understand whether adolescents with Type 2 Diabetes (2DM) can be transitioned to a continuous subcutaneous insulin injection (CSII) and if so, assess whether CSII is a feasible treatment modality and improves quality of life (QOL) in adolescents with T2DM over 3 month period.


Eligibility Criteria:
Inclusion Criteria:

* Adolescents with Type 2 Diabetes mellitus between the ages of 12- 23 years, who have had T2DM for at least 6 month duration, and who have had a HbA1c \> 8% in the preceding 3 months prior to enrollment into the study. As a diabetes is a chronic disease the AAP (American Academy of Pediatrics; 2002) definition of a "Pediatric patient "is from birth until 21 years old. There are patients in the Diabetes program that we sometimes follow for 2-3 years beyond this age of 21 years and therefore would like to offer this study until the age of 23 years. This will give opportunity to our patients to be recruited if they would choose to participate in the study.
* Confirmed T2DM as defined by American Diabetes Association i.e. FPG \> 126 mg/dL or blood sugar \> 200 mg/dl on a 2 hr, 75 g OGTT or random blood sugar \>200 mg/dl. Pubertal, Tanner stage \>1
* Subjects must be willing to comply with study protocol requirements
* Females must have a negative pregnancy test within 72 hours prior to the start of the study and on every subsequent study visit. If on any visit their pregnancy test is positive they will be asked to not continue in the study. If the adolescent is using contraception such as birth control pills they will be allowed to continue using them during the study as this should not affect glucose levels. Once a female is confirmed to be pregnant we will take the insulin pump and restart insulin injection regimen that they were before the start of the study. We will also make an aptt with "high risk obstretics" and encourage the adolescent to check their blood sugars at least 4-6 times per day.
* The patient must be on insulin to qualify for the study. The adolescents could be on oral hypoglycemic agent in addition to insulin to be included in the study.

Exclusion Criteria:

* Chart review of adolescents with T2DM will be done to confirm absence of glutamic acid decarboxylase, islet cell or insulin autoantibodies or secondary causes of diabetes
* Other significant major organ system illness
* Females who are pregnant at their initial assessment. We will be testing female participants on every visit with a urine pregnancy test and if they are found to pregnant we will ask them to stop using their pump and go back to using insulin injections.
* Significant psychiatric illness: schizophrenia, bipolar disorder, active substance abuse and uncontrolled major depression.
* All adolescents who have signs of renal insufficiency (creatinine clearance based on Schwartz equation \>0.55 for females and males 0.7 ages 13-18 years) (13). Serum creatinine will be available on the metabolic profile. Subjects with elevated CrCl will be excluded from the study.
Rabeprazole Specific Clinical Experience Investigation for the Long-term Combination Therapy With Low-dose Aspirin

To investigate the safety and efficacy of long-term combination therapy with rabeprazole and low-dose aspirin.


Eligibility Criteria:
Inclusion criteria:

1. Patients taking long-term low-dose aspirin for prevention of thrombus/embolism at the start of administration of rabeprazole (including patients who start low-dose aspirin on the same day as the start of administration of rabeprazole).
2. Patients with a history of gastric/duodenal ulcers.
3. Patients requiring long-term use of rabeprazole for prevention of recurrence of gastric/duodenal ulcers induced by low-dose aspirin.

Exclusion criteria:

1. Patients with gastric/duodenal ulcers at the start of administration of rabeprazole.
2. Patients with active upper gastrointestinal bleeding at the start of administration of rabeprazole.
3. Patients with contraindication for rabeprazole.
Effect of Celecoxib Versus Placebo Before and After Knee Surgery on Overall Use of Analgesics After Surgery

To compare total analgesic use at 24 hours after arthroscopic knee surgery in celecoxib-treated versus placebo-treated patients


Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria:

* Diagnosed (or suspected to have) meniscus trauma of the knee requiring ambulatory arthroscopic knee surgery
* Willing to participate in study for 36 hours and come to follow-up visit 7 days post surgery

Exclusion Criteria:

Exclusion criteria:

* Osteoarthritis, inflammatory arthritis, or previous fracture of index joint
* Received acetaminophen or low dose narcotic (vicodin/tylox) within 8 hours of surgery
* Have received oral (4 weeks), intramuscular (2 months), intra-articular (3 months) or soft-tissue (2 months) injections of corticosteroids of the first dose of study medication or intra-artcular injections of hyaluronic acid in the index joint within 9 months of the first dose of study medication
A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in People With Type 2 Diabetes Treated With Once-daily Basal Insulin With or Without Metformin

This study will look at how much CagriSema helps people with type 2 diabetes lower their blood sugar and body weight. CagriSema is a new investigational medicine. Doctors may not yet prescribe CagriSema. CagriSema will be compared to a "dummy" medicine (also called "placebo") that has no effect on the body. Participant will get either CagriSema or "dummy" medicine and which treatment they get is decided by chance. Participant will take the study medicine together with their current diabetes medicine (once-daily insulin with or without metformin). For each participant, the study will last for about one year.


Eligibility Criteria:
Inclusion Criteria:

* Male or female (sex at birth).
* Age 18 years or above at the time of signing the informed consent.
* Diagnosed with type 2 diabetes mellitus ≥180 days before screening.
* On stable once-daily dose of basal insulin (minimum of 0.25 units per kilogram per day (U/kg/day) or 20 U/day) alone or in combination with metformin (at effective or maximum tolerated dose as judged by the investigator) for 90 days prior to screening.
* Glycated haemoglobin (HbA1c) 7.0-10.5 percent (53-91 millimoles per mole \[mmol/mol\]) (both inclusive) as determined by central laboratory at screening.
* Body Mass Index (BMI) greater than or equal to 25 kilogram per square meter (kg/m\^2) at screening. BMI will be calculated in the electronic case report form (eCRF) based on height and body weight at screening.

Exclusion Criteria:

* Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method.
* Renal impairment with estimated Glomerular Filtration Rate (eGFR) less than 30 milliliters per minute per 1.73 square meter (mL/min/1.73 m\^2) as determined by central laboratory at screening.
* Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening.
* Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by an eye examination performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
* Known hypoglycaemia unawareness as indicated by the investigator according to Clarke's questionnaire question 8.
* Recurrent severe hypoglycaemic episodes within the last year as judged by the investigator.
A Double-blind, Placebo-controlled Trial of Donepezil Adjunctive Treatment for Cognitive Impairment in Schizophrenia

The objective of the study was to study the effects of donepezil on cognition in patients with schizophrenia. The investigators conducted a 12-week, double-blind, placebo-controlled trial of donepezil as adjunctive treatment to antipsychotic drugs on patients with schizophrenia.

The investigators conducted a 12-week, double-blind, placebo-controlled trial of donepezil as adjunctive treatment to antipsychotic drugs on patients with schizophrenia.The trial will be complete in 2012.

Eligibility Criteria:
Inclusion Criteria:

* DSM-IV diagnosis of schizophrenia as determined by the Structured Clinical Interview for DSM-IV Axis I Disorders-Clinician Version;
* Between 18 and 40 years of age;
* Duration of the illness must be longer than 2 year;
* Patient's current antipsychotic medication regimen must be stable;
* Must be in a stable living arrangement;

Exclusion Criteria:

* Patient has mental retardation or severe organic brain syndromes;
* Treatment with Electroconvulsive Therapy (ECT) within 6 months prior to screening;
* Has suicidal attempts or ideation or violent behavior within the last 12 months;
* Patient has a history of alcohol/drug dependence;