linjc16/ctgov huggingface dataset:
Study Evaluating Pantoprazole in Peptic Ulcer Hemorrhage

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and safety of intravenous pantoprazole in the prevention of rebleeding in patients with bleeding peptic ulcer disease after successful endoscopic hemostatic therapy.

Official Title
-----------------
An Efficacy and Safety Study of Intravenous Pantoprazole in the Prevention of Recurrent Peptic Ulcer Bleeding After Successful Hemostasis

Conditions
-----------------
Peptic Ulcer Hemorrhage

Intervention / Treatment
-----------------
* Drug: Pantoprazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must be men or non-pregnant women at least 18 years of age Patients who present with a gastric or duodenal ulcer Exclusion Criteria: Patients with ulcer appearance of clean base (non-oozing, non-spurting) or flat pigmented spot; adherent clots not removed by irrigation Patients presenting with active bleeding and/or NBVV at 2 or more separate sites Patients with any severe concomitant diseases, eg, end stage liver or renal disease, or unstable cardiovascular, pulmonary, renal, hepatic, or gastrointestinal diseases

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Pantoprazole|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Peptic, Ulcer, Hemorrhage
Nidek RS3000 Comparative Study

Study Overview
=================
Brief Summary
-----------------
The primary objective of this clinical study is to compare the Nidek RS-3000 Optical Coherence Tomography (OCT) device to the Optovue RTVue OCT. The secondary objective is to evaluate any adverse events found during the clinical study.

Official Title
-----------------
Comparative Study of the Nidek Optical Coherence Tomography RS-3000 and the RTVue OCT Predicate Device for the Measurements of Retinal and RNFL Thickness, Optic Disc Analysis, Pachymetry, Anterior Chamber Imaging and SLO Imaging.

Conditions
-----------------
Glaucoma, Retinal Disease, Corneal Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects of legal age and who have full legal capacity to volunteer on the date the informed consent is signed. Subjects who follow the instructions by Principal/Clinical Investigator or clinical staff at the clinical site, and can visit on a scheduled examination date. Subjects who sign an informed consent form to participate in the clinical study. Subjects who agree to take the qualifying examination and RS-3000 and RTVue data acquisition. Exclusion Criteria: Diabetes mellitus (DM) and/or diabetic retinopathy Hypertension (HT) Cerebral infarction, cerebral hemorrhage, cranial nerve neoplasm and other central nervous system diseases affecting vision Cardiac, hepatic, renal and hematologic diseases Current systemic administration of steroid History of anticancer agent etc. Optically-stimulated epileptic seizure Dementia Subjects who have other life threatening and debilitating systemic diseases NOTE: Additional detailed inclusion/exclusion ophthalmic criteria dependent upon study population also exist

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Normal Eyes<br>Eyes without disease | |
| Eyes with Glaucoma<br> | |
| Eyes with Retinal Disease<br> | |
| Eyes with Corneal Disease<br>Including post keratorefractive surgery | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Retinal Thickness |  | One Visit | 
| Inner Retinal Thickness |  | One Visit | 
| Outer Retinal Thickness |  | One Visit | 
| RNFL Thickness |  | One Visit | 
| Optic Disc Analysis |  | One Visit | 
| G Chart |  | One Visit | 
| Anterior Chamber Angle Image |  | One Visit | 
| SLO Image |  | One Visit | 
| Pachymetry |  | One Visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Any adverse events |  | One Visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Viewing and axial cross sectional imaging of ocular, structures, including the anterior chamber
Ph2a Study to Evaluate IW-3718 in Patients With Gastroesophageal Reflux Not Completely Responsive to Proton Pump Inhibitors

Study Overview
=================
Brief Summary
-----------------
This study is meant to assess the effect of IW-3718 as an added treatment to ongoing once-daily protocol pump inhibitor (PPI) treatment for patients who continue to experience symptoms of their gastroesophageal reflux disease (GERD).

Official Title
-----------------
A Phase 2a Study to Evaluate the Effect of IW-3718 Administered Orally for 4 Weeks in Patients With GERD Not Completely Responsive to Proton Pump Inhibitors

Conditions
-----------------
Gastroesophageal Reflux

Intervention / Treatment
-----------------
* Drug: IW-3718
* Drug: Matching Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is between 18 and 65 years of age at the Screening Visit; females must not be pregnant or must not be breastfeeding; Patient has a confirmed diagnosis of gastroesophageal reflux disease, must be currently taking a proton pump inhibitor (PPI), and must be experiencing GERD symptoms as specified by the protocol. Exclusion Criteria: Patient may not meet any of the excluded conditions specified in the protocol; Patient is experiencing alarm symptoms such as GI bleeding, anemia, vomiting, dysphagia, or unexpected weight loss; Patient has a clinically significant hypersensitivity or allergies to any of the active ingredients or excipients in the study medication.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IW-3718<br>Twice a day | Drug: IW-3718<br> <br> |
| Placebo Comparator: Matching Placebo<br>Twice a day | Drug: Matching Placebo<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exploratory Endpoints - GERD Symptoms |  | Change from baseline: Treatment Period (weeks 1-4) compared with 2-week (baseline) Pretreatment Period |
Gene Analysis in Studying Susceptibility to Wilms Tumor

Study Overview
=================
Brief Summary
-----------------
This clinical trial studies gene analysis in studying susceptibility to Wilms tumor. Finding genetic markers for Wilms tumor may help identify patients who are at risk of relapse.

Detailed Description
-----------------
PRIMARY OBJECTIVES: I. To use a genome-wide association analysis to identify novel genetic variants that confer susceptibility to Wilms tumor. II. To improve our understanding of the genetic architecture and etiology of Wilms tumor. III. To facilitate the identification of genetic markers that are associated with an increased risk of developing of Wilms tumor and/or those at risk of aggressive disease, relapse, additional tumors and/or cancer in their offspring. OUTLINE: Samples are analyzed for single nucleotide polymorphism (SNP) profiling using real-time polymerase chain reaction (PCR) and multiplex ligation-dependent probe amplification (MLPA).

Official Title
-----------------
A Genome-Wide Association Study in Wilms Tumor

Conditions
-----------------
Recurrent Childhood Kidney Neoplasm, Stage I Kidney Wilms Tumor, Stage II Kidney Wilms Tumor, Stage III Kidney Wilms Tumor, Stage IV Kidney Wilms Tumor

Intervention / Treatment
-----------------
* Other: Laboratory Biomarker Analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 3000 samples from the 1958 Birth Cohort (58C) and 3000 from the UK Blood Service control series (NBS)
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ancillary-correlative (genetic markers of Wilms tumor)<br>Samples are analyzed for SNP profiling using real-time PCR and MLPA. | Other: Laboratory Biomarker Analysis<br>* Correlative studies<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequencies between cases and controls at each SNP | Compared using the Cochran Armitage trend test (1-df). The data will be analyzed individually for the UK/US study populations and combined using a Mantel-Haenszel analysis adjusting for study group, and related methods which allow for different effects in each population (for confirmed loci, we will compare effects across populations). | Baseline | 
| Frequency of maternal and paternal allelic transmission for risk alleles | Compared using a chi-squared test. | Baseline | 
| Genetic variation on sub-phenotypes such as age at diagnosis, unilateral or bilateral disease, sex, and ethnicity |  | Baseline | 
| Interactions between genetic variation and treatment success or prognosis |  | Baseline | 
| Interactions between germline genetic variation and tumor phenotypes |  | Baseline |
The Effect of Using Mobile Applications for Improving Oral Hygiene

Study Overview
=================
Brief Summary
-----------------
The study aims to investigate the effect of the use of mobile phone application sending reminders to patients with orthodontic fixed appliances on oral hygiene.

Detailed Description
-----------------
Subjects were randomized into two groups, the first group received a mobile application that sends active reminders notifications of oral hygiene. The second group received verbal oral hygiene instructions during their regular visits to the orthodontics clinics.

Official Title
-----------------
The Effect of Using Mobile Applications for Improving Oral Hygiene in Patients With Orthodontic Fixed Appliances: A Randomized Controlled Trial

Conditions
-----------------
Orthodontic Appliance Complication

Intervention / Treatment
-----------------
* Behavioral: Mobile phone application
* Behavioral: Verbal oral hygiene instructions


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants were having orthodontic fixed appliance treatment. Participants were aged 12 years old and above, owned mobile phones and did not have mental or physical disabilities. Participants were willing to comply with given oral hygiene instructions.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mobile phone application<br>Subjects in this group received a mobile phone application that sends active reminder notifications of oral hygiene 3 times a day. | Behavioral: Mobile phone application<br> <br> |
| Active Comparator: Verbal oral hygiene instructions<br>Subjects in this group received verbal oral hygiene instructions during their regular orthodontic visits every 4 weeks. | Behavioral: Verbal oral hygiene instructions<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Plaque Index | Plaque index: 0, no plaque, 1, plaque seen on the tip of the explorer or with disclosing agent, 2. plaque seen with the naked eye, 3, abundance of plaque. | At baseline and after 4 weeks. | 
| Change in Gingival Index | Gingival index: 0, normal gingiva, 1, mild inflammation - slight change in color, slight edema and no bleeding on probing, 2, moderate inflammation - redness, edema and glazing and bleeding on probing, 3, severe inflammation - marked redness and edema, ulceration and tendency to spontaneous bleeding. | At baseline and after 4 weeks. |
Group-based Cognitive-behavioral Therapy for Adults With Attention-deficit/Hyperactivity Disorder Inattentive-type

Study Overview
=================
Brief Summary
-----------------
The newly developed CBT for ADHD inattentive-type (ADHD-I) protocol is tested for feasibility and acceptability in a pilot study with a single group design. The study also evaluates measurements and recruiting possibilities, and effects of the intervention. Research hypotheses include: 1. There is a basis for recruiting ADHD-I patients for participation in an RCT at psychiatric outpatient units, 2. The measurements in the study are feasible and reasonable in regards to patient characteristics; that is, the patients are responding to the questionnaires as intended, 3. The CBT for ADHD-I intervention is feasible in terms of treatment completion, compliance to home assignments, and credibility and relevance, and is lacking of or involves a tolerable degree of adverse effects, and 4. The CBT for ADHD-I protocol reduces core symptoms of ADHD-I as well as symptoms of stress, depression, and anxiety, and improves quality of life.

Official Title
-----------------
Group-based Cognitive-behavioral Therapy for Adults With Attention-deficit/Hyperactivity Disorder Inattentive-type: a Pilot Study

Conditions
-----------------
Attention Deficit Disorder With Hyperactivity

Intervention / Treatment
-----------------
* Behavioral: Cognitive-behavioral therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: In addition to an ADHD inattentive-type diagnosis, inclusion criteria are: 18 years or older, intelligence quotient above 80-85, and if on medication, it needs to be well-established since three months. Exclusion Criteria: autism spectrum disorder, ongoing substance use disorder, difficulties in compliance with medical or other treatment, social and/or psychiatric problems to such an extent that it prevents focusing on treatment, or ongoing cognitive-behavioral therapy.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cognitive-behavioral therapy<br> | Behavioral: Cognitive-behavioral therapy<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brown ADD Scales | Diagnostic measure | 14 weeks |
Lifestyle Management for Women With CHD and NIDDM

Study Overview
=================
Brief Summary
-----------------
To develop and evaluate a comprehensive lifestyle self-management (CLSM) program (low-fat vegetarian diet, smoking cessation and stress management training) for postmenopausal women with coronary heart disease and Type II (non-insulin dependent) diabetes.

Detailed Description
-----------------
BACKGROUND: Coronary heart disease is the leading cause of death among postmenopausal women. Yet few studies have examined the potential for altering risk factors for coronary heart diseases among postmenopausal women, especially as a result of comprehensive lifestyle changes. A pressing need existed for controlled studies to evaluate the effects of comprehensive lifestyle changes on risks for coronary heart disease among postmenopausal women. DESIGN NARRATIVE: The comprehensive lifestyle management program appeared to produce substantial cardiovascular benefits among men but little was known about the behavioral processes through which change occurred. Its generalizability and applicability -- especially for high-risk women --was uncertain. The program was compared to a usual care condition in an initial randomized trial. Outcome measures included patient self-care behaviors and health outcomes (serum lipid profiles, blood pressure, relative weight, and glycemic control). Process measures included self-efficacy, personal health models, perceived stress, social support and problem-solving skills. Subjects participated in the intervention for three years, with gradual fading of the program in the third year to evaluate the long-term effects of the program. Analyses included assessments of between groups differences on physiological risk factors, behavioral (lifestyle) measures and process measures as well as maintenance over time. Based upon the results of this study, the long-term goal was to design a second outcome study in which the revised intervention would be evaluated with a larger sample to determine the relative contribution of adding moderate exercise and the effects on reversal of coronary heart disease.

Conditions
-----------------
Cardiovascular Diseases, Coronary Disease, Heart Diseases, Diabetes Mellitus, Non-insulin Dependent, Postmenopause, Diabetes Mellitus

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Microbiome and Bariatric Surgery

Study Overview
=================
Brief Summary
-----------------
This is a prospective, 24-month, longitudinal study of patients planning to undergo bariatric surgery (Roux-en-Y Gastric Bypass or Sleeve Gastrectomy) in which we aim to identify correlates and predictors of observed weight loss trajectories following bariatric surgery. This approach will expand current knowledge by examining the combined impact of empirically supported behavioral and biological data in a large sample over time. Intensive measurement of problematic eating behaviors, mood, and compliance with diet and exercise regimens post-surgery will be analyzed in the context of lterations in parallel with, or in response to, changes observed in the gut microbiota. Identifying these post-surgical predictors of weight loss and comorbidity resolution will allow for the development of individualized interventions to optimize surgery-related outcomes.

Official Title
-----------------
Mechanisms That Predict Weight Trajectory After Bariatric Surgery: The Interactive Roles of Behavior and Biology

Conditions
-----------------
Weight Change, Body

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: In evaluation for Roux-en-Y Gastric Bypass or Sleeve Gastrectomy. Age 18-65, inclusive Exclusion Criteria: Alcohol or substance use disorder in past year Severe psychiatric disorder that may affect ability to complete the protocol Regular tobacco use during the last year Current medication taken routinely and known to impact factors that may affect the gut microbiome Use of any oral or injectable antibiotic in the past month Use of commercially available pre/pro biotic in the past month History of significant disease/disorder that would be expected to impact the microbiome of the gut Inability to engage in physical activity or dietary monitoring Nonprescribed/illicit drug use Pregnant or breastfeeding

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Roux-en-Y Gastric Bypass<br>Patients planning to undergo Roux-en-Y Gastric Bypass will be invited to participate in this study. | |
| Sleeve Gastrectomy<br>Patients planning to undergo Sleeve Gastrectomy will be invited to participate in this study. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight trajectory | Weight outcomes following bariatric surgery | 24 months |
Expanded Access Study Of Palbociclib (PD-0332991) In Combination With Letrozole As Treatment Of Post-Menopausal Women With HR-Positive, Her2-Negative Advanced Breast Cancer For Whom Letrozole Therapy Is Deemed Appropriate

Study Overview
=================
Brief Summary
-----------------
To provide access to palbociclib to post-menopausal women with HR-positive, HER2-negative advanced breast cancer who are deemed appropriate for letrozole therapy (Canada: first-line patients only).

Detailed Description
-----------------
This study is currently available in Canada only.

Official Title
-----------------
AN EXPANDED ACCESS STUDY OF PALBOCICLIB IN COMBINATION WITH LETROZOLE AS TREATMENT OF POST-MENOPAUSAL WOMEN WITH HORMONE RECEPTOR POSITIVE, HER2 NEGATIVE ADVANCED BREAST CANCER FOR WHOM LETROZOLE THERAPY IS DEEMED APPROPRIATE

Conditions
-----------------
Advanced Breast Cancer (Female)

Intervention / Treatment
-----------------
* Drug: Palbociclib
* Drug: Letrozole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Post-menopausal women 18 years of age or above with proven diagnosis of advanced adenocarcinoma of the breast (locoregionally recurrent or metastatic disease) ER-positive and/or PR-positive tumor based on local laboratory results HER2-negative tumor based on local laboratory results Patients must be appropriate candidates for letrozole therapy (Canada: first-line patients only) Exclusion Criteria: Patients who have previously participated in a palbociclib trial or who have received prior treatment with any CDK inhibitor

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Palbociclib|Palbociclib will be administered orally once a day at 125 mg/day for 21 days followed by 7 days off treatment for each 28-day cycle (Schedule 3/1)|
|Drug: Letrozole|Letrozole will be administered orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Expanded Access, Advanced Breast Cancer