linjc16/ctgov huggingface dataset:
Hemospray in Gastrointestinal Bleeding: A Real-life Multicenter Cohort

Study Overview
=================
Brief Summary
-----------------
This is an observational, retrospective, analytical, and multicenter study conducted at 17 hospitals. Our research aims to assess the effectiveness of Hemospray® in patients with gastrointestinal bleeding in clinical practice. Besides, we aim to detect predictors of treatment failure defined as unsuccessful immediate hemostasis or rebleeding.

Official Title
-----------------
Hemospray Effectiveness and Predictors of Rebleeding in Patients With Gastrointestinal Hemorrhage: A Real-life Multicenter Cohort.

Conditions
-----------------
Ulcer Hemorrhage, Tumor Bleeding, Gastrointestinal Hemorrhage

Intervention / Treatment
-----------------
* Device: Hemospray®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with gastrointestinal bleeding treated with Hemospray®. Exclusion Criteria: None.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hemospray® group<br>Patients with gastrointestinal bleeding treated with Hemospray®. | Device: Hemospray®<br>* Hemospray® application<br>* Other names: Hemostatic powder;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemospray® intraprocedural bleeding control | It refers to the proportion (%) of patients who achieves intraprocedural hemostasis with Hemospray®. Intraprocedural bleeding control is defined as endoscopic observation of bleeding cessation after Hemospray® use. | From Hemospray® first application up to the end of the endoscopic procedure. This variable should be assessed in day 1. | 
| Rebleeding rate | To describe the rebleeding rate (%) after Hemospray®. Rebleeding is defined as a new episode of hematemesis, rectorrhagia or melena; hemoglobin level decrease >2 g/dL within 48 h of the index endoscopy or direct visualization of active bleeding at the previously treated lesion at repeat endoscopy. | Date of Hemospray® application until rebleeding, assessed up to 48 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events potentially related to Hemospray® | Abdominal distension (Yes/no), Intestinal perforation (Yes/No). Unexpected adverse events will be also recorded and evaluated. | From Hemospray application until day +7 | 
| Mortality | % of patients who die after Hemospray® application | From Hemospray application until death, assessed up to 48 months or lost follow-up, whichever came first | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hemospray, Gastrointestinal bleeding, Gastrointestinal hemorrhage, Hemostatic powder
Study to Investigate Benefits of Weight Loss in Young Adults and Adolescents

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the changes in subcutaneous adipocyte size, number and gene expression after weight loss and to assess whether those changes contribute to decreases in ectopic fat accumulation and insulin resistance in women between ages of 16-32.

Detailed Description
-----------------
There are no studies in young women that have prospectively studied changes in fat cell size, gene expression and insulin sensitivity during the transition from overweight/obese to normal weight. Our preliminary data suggest that the presence of ectopic fat accumulation and insulin resistance in obese children could be considered an early phase in the development of T2DM. We hypothesize that a 10% weight loss will restore/improve insulin sensitivity. Furthermore, we speculate that the decrease in subcutaneous fat mass after weight loss is due to a decrease in mean adipocyte cell size, but not cell number.

Official Title
-----------------
Study to Investigate Benefits of Weight Loss in Yound Adults and Adolescents

Conditions
-----------------
Obesity, Insulin Resistance

Intervention / Treatment
-----------------
* Behavioral: Caloric restrictive diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women ages 16-32 Exclusion Criteria: They will not be on any medications that are known to alter glucose or insulin metabolism, such as oral steroids, or certain psychiatric medications, such as Xeleca, Lithium and Paxil. Patients on diuretics will be excluded.

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 32 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Weight Loss<br>Caloric restrictive diet | Behavioral: Caloric restrictive diet<br>* Patients will meet weekly with a registered dietician.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abdominal fat re-distribution with weight loss | To assess in young women, the effects of weight loss on abdominal fat distribution. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adipocyte cell size distrubtion and gene expression | With 10% weight loss, assess changes in cell size distribution and gene expression of adipocytes from the subcutaneous adipose depot. | 12 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obesity, Insulin Resistance, Weight loss, Women
Retention of Metal Reinforced Polyamide Denture Base and Heat Cured Acrylic Resin Denture Base in Complete Mandibular Denture

Study Overview
=================
Brief Summary
-----------------
The trial is done in order to reinforce polyamide to improve its modulus of elasticity to be able to use it as a denture base material in all clinical cases

Official Title
-----------------
Evaluation of Retention of Metal Reinforced Polyamide Denture Base Compared to Conventional Heat Cured Acrylic Resin Denture Base in Complete Mandibular Denture

Conditions
-----------------
Anodontia of Permanent Dentition

Intervention / Treatment
-----------------
* Other: polyamide
* Other: heat cured acrylic resin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patient with age range from fifty five to sixty five completely edentulous and in good medical condition Patients have skeletal Angle's class I maxillo-mandibular relationship and sufficient inter arch distance. Free from any systemic or neuromuscular disorder that might affect chewing efficiency of masticatory muscles. Free from any tempro-mandibular disease. Good oral hygiene. Exclusion Criteria: Neuromuscular disorder and orofacial disease. Tempromandibular joint and muscle pain xerostomia or excessive salivation. Limited mouth opening

Ages Eligible for Study
-----------------
Minimum Age: 55 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: polyamide<br>metal reinforced polyamide denture base material | Other: polyamide<br>* metal reinforced polyamide denture base material<br>* Other names: Nylon;|
| Active Comparator: heat cured acrylic resin<br>conventional heat cured acrylic resin denture base | Other: heat cured acrylic resin<br>* conventional heat cured acrylic resin denture base material<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retention assessed by digital forcemeter | Retention of mandibular denture | 6 weeks |
Inter Costal Catheters for Video-Assisted Thoroscopic (VATS) Lobectomy

Study Overview
=================
Brief Summary
-----------------
A pilot study to observe satisfaction of analgesia with intercostal catheters after VATS lobectomy.

Detailed Description
-----------------
Pain and satisfaction with pain treatment is investigated in a population after VATS lobectomy.

Official Title
-----------------
Pain Relief After VATS Lobectomy Using Interoperatively Placed Inter Costal Catheters.

Conditions
-----------------
Lung Cancer Patients

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age of consent (ie age>=18) Eligible for lobectomy Able to comply Willing to register postoperatively - Exclusion Criteria: do not understand DAnish

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 |
| --- | --- | --- |
| NRS (pain score 0-10)) | Painscore | Until discharge (2-4 days) | 
| satisfaction (Verbal ranking scale 1-4) | qualitative measurement | until discharge, 2-4 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effects (quantitatively, see details) | Daily presence of, Nausea Dizziness Vomiting Sedation Pruritus | until discharge, 2-4 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lung cancer, VATS Lobectomy
Stress & Social Cognition in Borderline Personality Disorder

Study Overview
=================
Brief Summary
-----------------
The investigators will examine whether perceived social exclusion provoke a reduction in prosocial behavior in BPD patients.

Detailed Description
-----------------
The investigators will examine whether perceived social exclusion provoke a reduction in prosocial behavior, such as empathy, in BPD patients and whether this fight-or-flight pattern is also seen in other relevant aspects of social behavior, such as sharing and punishment behavior. To induce social exclusion all participants will play cyberball, either the exclusion condition or the (over)inclusion condition before testing

Official Title
-----------------
Fight-or-flight Versus Tend-and-befriend Response to Behavioral and Pharmacological Interventions in Patients With Borderline Personality Disorder - Part I

Conditions
-----------------
Borderline Personality Disorder

Intervention / Treatment
-----------------
* Behavioral: inclusion condition


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: female patients with BPD and healthy control women, matched for age, body mass index, and education Exclusion Criteria: physical illness

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: exclusion BPD<br>cyberball exclusion condition - BPD patients | Behavioral: inclusion condition<br>* cyberball game: ex- versus over-inclusion condition<br>|
| Experimental: over-inclusion BPD<br>cyberball over-inclusion condition - BPD patients | Behavioral: inclusion condition<br>* cyberball game: ex- versus over-inclusion condition<br>|
| Experimental: exclusion healthy controls<br>cyberball exclusion condition - healthy controls | Behavioral: inclusion condition<br>* cyberball game: ex- versus over-inclusion condition<br>|
| Experimental: over-inclusion healthy controls<br>cyberball over-inclusion condition - healthy controls | Behavioral: inclusion condition<br>* cyberball game: ex- versus over-inclusion condition<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| empathy | Multifaceted Empathy Test | 30 minutes after cyberball | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sharing behavior: amount of monetary units (max 30) shared with co-player | Computer game | directly after cyberball |
Tolerability of ALK Grass Tablet in Children

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to assess whether the ALK Grass tablet treatment is safe to use in children aged 5-12 years

Official Title
-----------------
A Randomised, Double-Blind, Placebo-Controlled, Multi-Centre Phase I Trial Investigating the Safety of ALK Grass Tablet in Children Aged 5-12 Years With Grass Pollen Induced Rhinoconjunctivitis (With/Without Asthma)

Conditions
-----------------
Allergy

Intervention / Treatment
-----------------
* Biological: ALK Grass tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Grass pollen induced rhinoconjunctivitis Boys and girls, 5-12 years of age Positive skin prick test to grass pollen Exclusion Criteria: Severe asthma Previous treatment with immunotherapy

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 12 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: ALK Grass tablet|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of safety by recording of adverse events |  |  |
Effects of Amlodipine/Benazepril in Reducing Left Ventricular Hypertrophy in Patients With High Risk Hypertension

Study Overview
=================
Brief Summary
-----------------
Left ventricular hypertrophy (LVH) increases the risk of cardiovascular morbidity and mortality in patients with high blood pressure, compared to those without LVH. Reduction of left ventricular mass (LVM) with antihypertensive agents is associated with improved clinical outcome. This study will evaluate the effects of amlodipine/benazepril in reducing LVM in patients with high risk hypertension.

Official Title
-----------------
Effects of Amlodipine/Benazepril in Reducing Left Ventricular Hypertrophy in Patients With High Risk Hypertension

Conditions
-----------------
Hypertension, Left Ventricular Hypertrophy

Intervention / Treatment
-----------------
* Drug: amlodipine/benazepril


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males or female patients ≥ 55 years of age LVH as confirmed by echocardiogram Patients with high risk hypertension, currently treated or already taking antihypertensive medication Exclusion Criteria: Renal artery stenosis Symptomatic heart failure or known ejection fraction < 40% Myocardial infarction or stroke within 6 months Presence of cranial aneurysm clips, coronary artery metal stents and pacemakers Pregnant or lactating females Cancer within the last 5 years

Ages Eligible for Study
-----------------
Minimum Age: 55 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: amlodipine/benazepril|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in left ventricular mass index after 52 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in left ventricular mass after 52 weeks |  |  | 
| Change from baseline in diastolic function after 52 weeks |  |  | 
| Change from baseline in aorta function assessed blood pressure measurements after 52 weeks |  |  | 
| Change from baseline in markers of fibrosis and increased heart size after 52 weeks |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertension, Left ventricular hypertrophy
Validation of Pulse Waveform Analysis-based Continuous Noninvasive Blood Pressure Measurement Sensor

Study Overview
=================
Brief Summary
-----------------
The study aims to define the sensitivity and specificity of a novel continuous noninvasive blood pressure monitor.

Detailed Description
-----------------
A novel continuous noninvasive blood pressure monitor is compared to invasive arterial measurement at postoperative care unit after a planned operation. Monitor captures also saturation and ECG, which are compared to traditional monitoring.

Official Title
-----------------
Validation of Pulse Waveform Analysis-based Continuous Noninvasive Blood Pressure Measurement Sensor

Conditions
-----------------
Blood Pressure

Intervention / Treatment
-----------------
* Device: Study Monitor used


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: subjected to operative treatment with the need for invasive blood pressure measurement spontaneous ventilation able to give informed consent Exclusion Criteria: denial by patient pacemaker

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: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study goup<br>Vital values are being measured for the time of two hours at postoperative setting at postanesthesia care unit. A novel method is compared to golden standard: invasive measurement. Also Saturation measurements are being compared between standard and study monitor. | Device: Study Monitor used<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relationship between invasive and noninvasive blood pressure measurement | comparability of study monitor systolic, diastolic and mean blood pressure to invasive blood pressure measurement | 2 hours of continuous measurement at PACU | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relationship between study monitor Sp02 measurement and current sp02 measurement | comparability of measurements at several timepoints recorded as 10s intervals | 2 hours of continuous measurement at PACU | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sensitivity, specificity, novel blood pressure monitor, Saturation
Overcoming Obstacles to Clinical Trials Enrollment Through a Navigator Program

Study Overview
=================
Brief Summary
-----------------
Pilot study for assessing the effectiveness of a Navigator program to aid in clinical trial participation amongst the Chinese demographic

Official Title
-----------------
Overcoming Obstacles to Clinical Trials Enrollment Through a Navigator Program

Conditions
-----------------
Genital Neoplasms, Female, Gynecologic Cancers, Breast Cancer

Intervention / Treatment
-----------------
* Behavioral: Navigator Support


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cancer patients for Focus Group must meet the following criterion: diagnosis of any gynecologic or breast cancer and be pursuing treatment here at Stanford within the last 2 years must read and speak Chinese willing and able to participant in group discussions Cancer patients to receive Navigator Support must meet the following criterion: Newly diagnosed with gynecologic or breast cancer -pursuing treatment at Stanford Cancer Center must read and speak Chinese willing and able to have an individual relationship with a Navigator Health Professional must meet the following criterion: -must currently work in the Stanford gynecologic Oncology Clinic Navigators must meet the following criterion: Chinese and English speaking willing and able to participate in training and to serve as a Navigator preferably a Cancer survivor Exclusion Criteria: Cancer patients must have a GOG performance status of 0-2 (see attached document for further details). Focus Group participate MAY be able to be participating in another study but patients who are already participating in a clinical trial will not be assigned a Navigator. No Exclusionary criterion for Health Professionals or Navigators.

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 |
| --- |
|Behavioral: Navigator Support|Standard of Care|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| feasibility of the program |  | one year |