linjc16/ctgov huggingface dataset:
Nexium Capsules Helicobacter Pylori Specific Clinical Experience Investigation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to confirm the safety profile / factors which impact safety and efficacy in patients given triple therapy for Helicobacter pylori eradication with Nexium + amoxicillin (AMPC) + clarithromycin (CAM), or Nexium + AMPC + metronidazole (MNZ) in usual post-marketing use.

Detailed Description
-----------------
Nexium capsules Specific Clinical Experience Investigation concerning Helicobacter pylori eradication

Official Title
-----------------
Nexium Capsules Specific Clinical Experience Investigation Concerning Helicobacter Pylori Eradication

Conditions
-----------------
Gastric Ulcer, Duodenal Ulcer, Gastric Mucosa-associated Lymphoid Tissue (MALT), Lymphoma Idiopathic Thrombocytopenic Purpura, Early Gastric Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Triple therapy for H.pylori eradication to stomach started after endoscopic treatment for gastric ulcer Triple therapy for H.pylori eradication to stomach started after endoscopic treatment for duodenal ulcer Triple therapy for H.pylori eradication to stomach started after endoscopic treatment for gastric MALT lymphoma Triple therapy for H.pylori eradication to stomach started after endoscopic treatment for idiopathic thrombocytopenic purpura Triple therapy for H.pylori eradication to stomach started after endoscopic treatment for early gastric cancer Exclusion Criteria: - H.pylori negative at the time when the triple therapy is started
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Nexium<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Adverse Drug Reactions |  | Period from the start of triple therapy to assessment of eradication, an expected average of 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of H.Pylori eradication |  | Period from the start of triple therapy to assessment of eradication, an expected average of 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
triple therapy, Helicobacter pylori, eradication, Nexium
Acute Intervention to Reduce Distress Following Sexual Assault

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to evaluate whether a brief intervention in video format delivered in the post assault medical exam setting and including education about assault reactions and instruction in and modeling of successful coping strategies would reduce post assault drug use or abuse and PTSD symptoms as compared to standard care.

Detailed Description
-----------------
The intervention being evaluated was shown at the time of the post assault medical exam and includes two main components: preparation for the medical exam; and information about and modelling of coping strategies that may help women cope in the aftermath of assault. The intervention content is delivered via video. Intervention and standard care groups were compared with regard to measures of substance use and abuse and symptoms of PTSD and other potentially comorbid problems including symptoms of depression or other anxiety.

Official Title
-----------------
Prevention of Post-Rape Psychopathology and Drug Abuse

Conditions
-----------------
Drug Use, Drug Abuse, Posttraumatic Stress Disorder

Intervention / Treatment
-----------------
* Behavioral: PPRS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Seeking medical care after recent sexual assault Exclusion Criteria: Active psychosis Active suicidality Cognitive impairment Non-English speaking Severe injury

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 90 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PPRS video<br>Prevention of post sexual assault stress | Behavioral: PPRS<br>* Video including psycho-education and modeling of adaptive behavioral coping strategies for use post-assault.<br>|
| No Intervention: Standard care<br>Receipt of standard services | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of specific drug use | Number of days use of specific drugs in preceding 14 days at 6 week, 3 and 6 month follow-ups | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Specific Drug Abuse | Criteria for DSM-IV substance abuse based on structured interview | 1.5, 3, 6 months | 
| PSS-SR | Measure of PTSD symptoms | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rape, Secondary prevention, Intervention
Retrospective Evaluation of Patient Failure to Follow-up at a Community Based Headache Clinic

Study Overview
=================
Brief Summary
-----------------
This is a retrospective review of the records of patients seen at the Kilgo Headache Clinic in Alabama between 7/1/05 and 6/30/07. The goal of the study is to identify factors at the time of the initial office visit that can be used to predict failure to follow-up.

Official Title
-----------------
If You Build it, They Will Come; But Will They Return for Follow-up? A Retrospective Assessment of Potential Risk Factors for Patient Failure to Follow-up at a Community Based Headache Clinic

Conditions
-----------------
Headache

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Headache Initial office visit between 7/1/05 and 6/30/07 Exclusion Criteria: None

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

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

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 |
| --- | --- | --- |
| Adherence to followup recommendations |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Headache, Adherence, Followup
International Multisite Transcatheter Tricuspid Valve Therapies Registry

Study Overview
=================
Brief Summary
-----------------
For a long time, tricuspid valve disease has been considered as less important than left-sided valvular heart disease. If treated in an advanced stage and simultaneously with other cardiac diseases, it is associated with significant morbidity and mortality. Hence, physicians tend to refer patients more aggressively to surgery (1). Transcatheter procedures are an attractive alternative in high-risk patients. The field of transcatheter tricuspid devices has rapidly advanced over the last few years (2). Limited knowledge is available regarding the epidemiologic and anatomical settings in which these therapies are preferentially applied. The main purpose of this registry is the collection of baseline clinical and anatomical data of the patients treated with transcatheter tricuspid valve therapies, and their outcomes, whenever feasible. Apart from more knowledge regarding the current status in this field, the results could also help the establishment of guidelines with respect to the choice of the transcatheter device selected and to understand which therapy can provide the better outcome in the different anatomies. Moreover, this study will provide important information about the epidemiology of severe tricuspid regurgitation, which is at the moment an undertreated disease.

Official Title
-----------------
International Multisite Transcatheter Tricuspid Valve Therapies Registry

Conditions
-----------------
Severe Tricuspid Regurgitation

Intervention / Treatment
-----------------
* Device: Transcatheter Tricuspid Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All the patients undergoing transcatheter tricuspid valve intervention. General inclusion criteria: Minimal age: 18 years Patient is able to give written informed consent to the procedure Exclusion Criteria: Patients not fulfilling the indications for transcatheter tricuspid intervention

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Transcatheter Tricuspid Intervention|Any available transcatheter tricuspid valve intervention|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular Death |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NYHA Class |  | 30 days, 1 year | 
| TR Reduction |  | 30 days, 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tricuspid Valve, tricuspid regurgitation, transcatheter tricuspid regurgitation
Locally Applied Pressure-induced Vasodilatation

Study Overview
=================
Brief Summary
-----------------
Measure microcirculatory responses after localized ischemia obtained by local application of pressure (laser speckle).

Detailed Description
-----------------
Measure microcirculatory responses after localized ischemia obtained by local application of pressure (laser speckle). The purpose of this study is to perform measurements of the methodological points made. The study will investigate : The effect of the duration and intensity of the pressure The reproducibility of measurements The correlation with ischemic hyperemia post

Official Title
-----------------
Réponse à l'Application d'Une Pression Locale en Laser Speckle Imaging Locally Applied Pressure-induced Vasodilatation

Conditions
-----------------
Vascular Diseases

Intervention / Treatment
-----------------
* Other: microcirculatory responses


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: subjects without vascular pathology Exclusion Criteria: pregnancy allergy tape

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?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: microcirculatory responses<br>Measure microcirculatory responses after localized ischemia obtained by local application of pressure (laser speckle). A pressure is applied to the subject's arm. this causes a localized ischemia. the measures responses to this ischemia will be made by the imager speckle (LSCI) give the microvascular perfusion data. | Other: microcirculatory responses<br>* The effect of the duration and intensity of the pressure; reproducibility and correlation with ischemic hyperemia post. measurements are made with the Imager SPECKLE imager (LSCI) give the microvascular perfusion data in arbitrary units called perfusion units (UP).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| microcirculatory response to local pressure. Measurements are made with the Imager SPECKLE imager (LSCI) give the microvascular perfusion data in arbitrary units called perfusion units (UP). | Measurements are made with the Imager SPECKLE imager (LSCI) give the microvascular perfusion data in arbitrary units called perfusion units (UP). | 2 hours |
Determinants of Penumbra in Acute Ischemic Stroke Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to examine the influence of demographic, clinical and laboratory characteristics on the presence and size of penumbra in acute ischemic stroke patients and to determine those of them which related significantly and independently to the presence and size of Penumbra. The examined factors will include demographic variables such as age, gender, ethnic background, vascular risk factors and medical history, clinical parameters such as time from stroke onset until arrival to the hospital, results of neurological evaluation by NIHSS and imaging findings, laboratory tests such as body temperature, blood pressure, glucose level, renal functions etc. and imaging findings - the presence and the size of collateral blood vessels, the state of carotid arteries (by CTA). The possible correlation between all this parameters and the presence and the size of penumbra as detected by CTP will be further examined.

Official Title
-----------------
Determinants of Penumbra in Acute Ischemic Stroke Patients

Conditions
-----------------
Acute Ischemic Stroke

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute ischemic stroke patients hospitalized in Rambam Health Care Campus between 2008-2010, and which have underwent neurological evaluation including NIHSS scale, Brain CT, CT angio and Ct perfusion. Exclusion Criteria: Intracranial hemorrhage of any other brain condition
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| stroke<br>acute ischemic stroke patients | |

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
-----------------
stroke, penumbra, determinants, CT perfusion
Golf and Diabetes.

Study Overview
=================
Brief Summary
-----------------
This a randomised, single-blinded, controlled study that investigate if a free golf training programme will increase the physical activity of type 2 diabetes patients.

Official Title
-----------------
Golf and Diabetes Can an Introctionary Course to Golf and a Free 1-year Membership in a Golf Club Increase Physichal Activity?

Conditions
-----------------
Type2 Diabetes

Intervention / Treatment
-----------------
* Behavioral: Golf
* Behavioral: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with type 2-diabetes Physical activity less than 8000 steps per day Age > 18 years Exclusion Criteria: Pregnancy Conditions that makes patients unfit for participation in golf

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Golf<br>In three different golf clubs patients will be introduced how to play golf. They will be taught techniques and recieve basic golf equipment. A total of 1 year membership free membership in the golf clubs will be given. | Behavioral: Golf<br>* A free golf course and free membership for one year in a golf club will be given to participants.<br>|
| Placebo Comparator: Placebo<br>No intervention given. No restrictions on physical activity. | Behavioral: No intervention<br>* Patients acting as controls will not be restricted in any ways.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical activity | Change in physical activity level from baseline to end of study evaluated by 7-days wear of accelerometers. | Evaluated at baseline and after 6 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | Use of validated questionaries to evaluate impact of quality of life | Evaluated at baseline and after 6 and 12 months | 
| Hand muscle strength | Change in hand muscle strength | Evaluated at baseline and after 6 and 12 months | 
| Diabetic control | Changes in diabetes related biochemistry and cardiovascular risk factors | Evaluated at baseline and after 6 and 12 months | 
| Adherence | Adherence evaluated with diarries | Evaluated at baseline and after 6 and 12 months | 
| Estimated VO2max | Two point bicycle test, where an estimated VO2 max can be calculated | Evaluated at baseline and after 6 and 12 months |
Randomized Trial on Scarpa Fascia Preservation During Hernio-abdominoplasty

Study Overview
=================
Brief Summary
-----------------
This randomized trial aimed to assess the efficacy of preservation of Scarpa's fascia during hernio-abdominoplasty in reducing the volume of postoperative drainage, accelerating time to drain removal and recovery, and reducing complication rate.

Official Title
-----------------
Scarpa Fascia Preservation Versus Removal During Hernio-abdominoplasty: a Randomized Controlled Trial

Conditions
-----------------
Ventral Hernia

Intervention / Treatment
-----------------
* Procedure: Scarpa's preserving hernio-abdominoplasty
* Procedure: Classical hernio-abdominoplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with complex ventral hernia that are fit for surgery (ASA class I and II) (Saklad, 1941). Patients with class III, IV according to Pitanguy's classification of abdominal deformities (Pitanguy, 1995). Exclusion Criteria: Patient with ASA class III, IV, and V. Morbid obesity (BMI > 40). Recurrent incisional hernias after mesh hernioplasty. Strangulated hernias. Isolated small paraumbilical hernias. Patients with abdominal organomegaly and/or ascites. Patients with coagulopathy, Patients who are heavy smokers, patients with pulmonary problems, and patients with uncontrolled diabetes.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Scarpa's preserving hernio-abdominoplasty<br>Hernio-abdominoplasty is performed with preservation of Scarpa's fascia. | Procedure: Scarpa's preserving hernio-abdominoplasty<br>* Scarpa's fascia is preserved during hernio-abdominoplasty<br>|
| Active Comparator: Classical hernio-abdominoplasty<br>Hernio-abdominoplasty is performed with removalof Scarpa's fascia. | Procedure: Classical hernio-abdominoplasty<br>* Scarpa's fascia is removed during hernio-abdominoplasty<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volume of postoperative drainage | The volume of fluid drained through suction drains per 24 hours | Two weeks after surgery |
Overall Diet Quality and Breast Cancer Risk

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to examine the relationship between indices of overall diet quality and incident breast cancer risk in a large prospective cohort of women.

Detailed Description
-----------------
This study examined the role of overall diet quality on the risk of developing invasive breast cancer among 96,959 women in the California Teachers Study, in which 4,826 women were diagnosed with breast cancer during follow-up (1995-2011). Participants' dietary habits were recorded at baseline (1995) using a 103-item Block95 Food Frequency Questionnaire to allow for the assessment of overall diet quality. Specifically, diet quality was characterized by the Alternate Mediterranean Diet (aMED), Alternative Healthy Eating Index-2010 (AHEI-2010), Dietary Approaches to Stop Hypertension (DASH), and Paleolithic Index scores. Associations between diet quality and the risk of developing breast cancer were examined using multivariate Cox proportional hazard regression models to provide hazard ratios and corresponding 95% confidence intervals.

Official Title
-----------------
Diet Quality Scores and Risk of Incident Breast Cancer in Healthy Women

Conditions
-----------------
Invasive Breast Cancer, Incident Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants with no history of cancer diagnosis prior to baseline. Participants with no history of myocardial infarction prior to baseline. Participants with no history of stroke prior to baseline. Participants with no history of diabetes prior to baseline. Participants who are not missing excessive dietary data. Participants with energy intake values at ≥1% and ≤99% of the population distribution.
Sexes Eligible for Study
-----------------
Female

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incident Invasive Breast Cancer | All incident cancer cases were identified through linkage with the California Cancer Registry (CCR) records, which is a population-based cancer registry for California residents. | 1995-2011 |