linjc16/ctgov huggingface dataset:
Genomic Predictors of Papillary Microcarcinoma Disease Progression

Study Overview
=================
Brief Summary
-----------------
The study is being done to answer the following question: What are the specific clinical and molecular features that will help us predict which small thyroid cancers are likely to grow and be problematic? Therefore, the purpose of this study is to identify specific clinical and molecular characteristics that are predictive of tumor progression in small thyroid cancers.

Official Title
-----------------
Genomic Predictors of Papillary Microcarcinoma Disease Progression

Conditions
-----------------
Papillary Microcarcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Biopsy proven papillary thyroid cancer (or suspicious for papillary thyroid cancer) confirmed by MSKCC cytopathologist. Being followed with active surveillance at MSKCC Biopsied index nodule less than or equal to 2 cm in maximum dimension Thyroid and neck US performed and interpreted by a MSKCC radiologist within 6 months prior to study entry. Exclusion Criteria: Biopsied index nodule greater than 2 cm in any dimension Age less than 18 yrs old

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Papillary Microcarcinoma<br>This clinical trial protocol describes implementation of a prospective observation protocol to standardize data collection and obtain permission to collect samples of PMC tumors in a cohort of PMC patients being followed with active surveillance. This will allow PMC tumors to be accurately classified as either stable or progressive over time and used for comprehensive molecular profiling if surgical removal is required during follow-up | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| estimate the disease progression rate | Therefore, in order to ensure that we will have at least 459 patients with PTC being followed with active surveillance, we plan to enroll 500 total patients, of which 350 will have FNA diagnostic for PTC (of which 99% are expected to have PTC) and 150 patients will have FNA suspicious for PTC (of which 113 would be expected to have PTC). This sample size will enable us to estimate the 5 year disease progression rate requiring intervention to within ±4% at 95% confidence level (using binomial calculation under the assumption that the study is not stopped early and the progression rate is not higher than 10%). | 4 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Genomic Predictors, 14-277
Dynamic Substrate Mapping (DSM) for Ischemic VT

Study Overview
=================
Brief Summary
-----------------
This is a prospective, non-randomized study to determine the feasibility of using a new technique called Dynamic Substrate Mapping (DSM) to help guide the treatment of ischemic ventricular tachycardia (IVT). We hypothesize that DSM will lead to simpler, more effective ablation of IVT. Results from this study will be used to determine if further clinical investigation is warranted.

Official Title
-----------------
Clinical Feasibility of Using Dynamic Substrate Mapping to Guide Ablation of Ischemic Ventricular Tachycardia

Conditions
-----------------
Ischemic Ventricular Tachycardia

Intervention / Treatment
-----------------
* Device: Dynamic Substrate Mapping-guided ablation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have an ICD or CRT-D device Had at least 3 documented device therapies to treat VT over last 3 months Clinical VT is confirmed or suspected to be of ischemic origin Scheduled for VT ablation procedure LVEF > or = 20% Exclusion Criteria: Inadequate AAD washout (amiodarone should be maintained at current dose) Unstable angina Active ischemia Cardiac surgery within prior 2 months Evidence of infection Prosthetic mitral or aortic valve or mitral/aortic valvular heart disease requiring surgical intervention History of embolic event Myocardial infarction within prior 6 weeks Enrolled in another study Recurrent sepsis or otherwise not a candidate for catheterization Hypercoagulable state or inability to tolerate heparin therapy during procedure Has had an atriotomy or ventriculotomy within prior 4 months Life expectancy < 6 months Class IV NYHA classification

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: DSM<br>Treatment using DSM to guide ablation | Device: Dynamic Substrate Mapping-guided ablation<br>* Radiofrequency ablation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of serious adverse events (SAEs) |  | 30 days |
Effect of 2-year Administration of CP-945,598 on Weight Loss Efficacy and Safety.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the long-term weight loss and safety of CP-945,598 in obese adults

Detailed Description
-----------------
The CP-945,598 program was terminated on November 3, 2008 due to changing regulatory perspectives on the risk/benefit profile of the CB1 class and likely new regulatory requirements for approval. No safety issues were involved in the termination decision.

Official Title
-----------------
A 2-Year, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study To Evaluate The Long-Term Efficacy And Safety Of CP-945,598 In The Treatment Of Obese Subjects

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Drug: CP-945,598 Treatment B
* Drug: CP-945,598 Treatment A
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Obese adults with a body mass index > or = 30 kg/m ; > or = 27 kg/m2 for those with obesity-related comorbidities including hypertension and dyslipidemia Exclusion Criteria: Pregnancy Diabetes Adults with serious or unstable current or past medical conditions

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CP-945,598 Treatment B<br> | Drug: CP-945,598 Treatment B<br>* Subjects receive CP-945,598 plus dietary, physical activity, and behavioral counseling.<br>|
| Experimental: CP-945,598 Treatment A<br> | Drug: CP-945,598 Treatment A<br>* Subjects receive CP-945,598 plus dietary, physical activity, and behavioral counseling.<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Subjects receive placebo plus dietary, physical activity, and behavioral counseling.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body weight and proportion of subjects with 5% weight loss |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Waist circumference, blood lipids and glucose, prevalence of metabolic syndrome, patient reported outcomes, population PK |  | 1-2 years |
Study in Toddlers (12-18 Months) Comparing a Booster Dose of Vaxem Hib and Hiberix Vaccines for the Prevention of Haemophilus Influenzae Type b Infections in China

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the safety and immunogenicity of booster doses of the two vaccines used to prevent Haemophilus influenzae type b infections in children 12-18 months of age.

Official Title
-----------------
A Phase III Open Label, Multi-Center Pediatric Study in China Comparing Booster Doses of Vaxem Hib and Hiberix Vaccines for the Prevention of Haemophilus Influenzae Type b (Hib) Infection

Conditions
-----------------
Haemophilus Influenzae Type b (Hib) Infection

Intervention / Treatment
-----------------
* Biological: Vaxem Hib (Haemophilus influenzae type b (Hib) vaccine)
* Biological: Hiberix (Haemophilus influenzae type b (Hib) vaccine)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Toddlers 12-18 months of age who have previously participated in study M37P2. Exclusion Criteria: Prior Hib booster administration. History of serious reaction(s) following vaccination. Vaccination within 14 days of study vaccination. Known or suspected immune impairment. For additional entry criteria please refer to the protocol.

Ages Eligible for Study
-----------------
Minimum Age: 12 Months
Maximum Age: 18 Months

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1<br> | Biological: Vaxem Hib (Haemophilus influenzae type b (Hib) vaccine)<br>* Comparator study of two commercially available Haemophilus influenzae type b (Hib) vaccines.<br>|
| Active Comparator: Arm 2<br> | Biological: Hiberix (Haemophilus influenzae type b (Hib) vaccine)<br>* Comparator study of two commercially available Haemophilus influenzae type b (Hib) vaccines.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-PRP antibody levels at day 31 post booster |  | 31 days after vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Solicited local and systemic reactions, AEs, and SAEs |  | 30 days post vaccination | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Haemophilus influenzae type b (Hib), Vaccine, Booster
Observing Infant Feeding Interactions

Study Overview
=================
Brief Summary
-----------------
The objective of the proposed research is to conduct a within-subject experimental study that will assess the effect of environmental distractions on a mothers' ability to recognize and feed in response to infants' feeding cues. Investigators hypothesize that mothers will spend significantly more time looking at their technology compared to looking at their infant, which will be negatively associated with the mothers' responsiveness to her infant. This will have a positive association with infant intake during the feeding. Investigators also hypothesize that mothers will show less sensitivity when distracted when compared to when they are not distracted.

Conditions
-----------------
Classical Music, Television Show

Intervention / Treatment
-----------------
* Behavioral: Technology distraction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mothers must be 18 years or older Infants must be between 0-6 months of age Exclusion Criteria: Preterm birth Medical conditions that interfere with feeding

Ages Eligible for Study
-----------------
Maximum Age: 6 Months

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Classical Music versus Television show<br>This is within-subject study; all infants will be exposed to both conditions. Order of presentation will counterbalanced across infants. | Behavioral: Technology distraction<br>* Infants will be fed with classical music playing in the background for one feeding and with a television show playing for the mother to watch during the other.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infant intake within a feeding (mL) | Infant intake within a feeding (mL) assessed by weighing the bottle or infant, depending on the type of feeding, before and after the feeding. | 2-hour period | 
| Maternal responsiveness | Maternal responsiveness to infant cues during a feeding assessed by the Nursing Child Assessment Satellite Training Parent-Child Interaction Feeding Scale. | 2-hour period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
infant feeding, breast-feeding, bottle-feeding, feeding interactions, maternal feeding practices
Effects of Antihypertensive Treatment in HIV Infected Patients: Candesartan Versus Lercanidipine

Study Overview
=================
Brief Summary
-----------------
Human immunodeficiency virus infection and highly active antiretroviral therapy (HAART) are associated with an increased risk of cardiovascular disease: a wide range of alterations in lipid and glucose metabolism has been increasingly recognized in HIV patients treated with HAART. Few data are available on the effects of antihypertensive treatment on cardiac morpho-functional characteristics and metabolic parameters in HIV patients. Aim of the study is to assess the effects of chronic therapy with angiotensin receptor blocker(candesartan)or calcium channel blocker (lercanidipine)on metabolic profile and cardiac remodelling in HIV hypertensive patients.

Official Title
-----------------
Effects of Antihypertensive Treatment on Cardiac Remodelling and Metabolic Profile in HIV Infected Patients: Randomized Longitudinal Study With Candesartan Versus Lercanidipine

Conditions
-----------------
HIV Infections, Hypertension

Intervention / Treatment
-----------------
* Drug: candesartan
* Drug: lercanidipine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV infection office blood pressure > 140/90 mmHg no antihypertensive treatment good quality echocardiogram Exclusion Criteria: cardiovascular diseases hypothyroidism diabetes secondary hypertension hepatic and renal failure

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>candesartan 8-16 mg once daily | Drug: candesartan<br>* tablet 8-16 mg once daily, one year<br>|
| Active Comparator: 2<br>lercanidipine 10-20 mg once daily | Drug: lercanidipine<br>* tablets 10-20 mg once daily, one year<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| morpho-functional left ventricle characteristics |  | one year | 
| metabolic profile |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| systolic and diastolic blood pressure |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV, blood pressure, left ventricle, metabolic profile, treatment experienced
French National Registry of Adults With Growth Hormone Deficiency Treated With Somatropin

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Europe. The aim of this study is to extract data from the French National Registry holding information about patients having initiated growth hormone therapy with the objective to describe patients receiving growth hormone therapy, assess efficacy and safety of somatropin (Norditropin® SimpleXx®) and evaluate treatment compliance.

Official Title
-----------------
Prospective, Longitudinal and National Follow-up Program of Adult Patients With Somatotropic Hormone Deficiency for Whom Substituting Treatment by Norditropin SimpleXx Was Started

Conditions
-----------------
Growth Hormone Disorder, Adult Growth Hormone Deficiency

Intervention / Treatment
-----------------
* Drug: somatropin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult with growth hormone deficiency Treated with Norditropin® SimpleXx (somatropin)
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Users of somatropin<br> | Drug: somatropin<br>* Data are extracted from the French National Registry l'Observatoire National des Prescriptions et Consommations de Médicaments to where physicians report data about growth hormone treatment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight |  | Once a year for 5 years | 
| Body composition |  | Once a year for 5 years | 
| Waist:Hip Ratio |  | Once a year for 5 years | 
| Body mass index (BMI) |  | Once a year for 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IGF-1 (Insulin-like growth factor 1) concentration |  | Once a year for 5 years | 
| Lipids: Total cholesterol, high-density lipoprotein (HDL), low-density lipoprotein (LDL) and triglycerides |  | Once a year for 5 years | 
| Dose prescribed |  | Once a year for 5 years |
The Effect Of Aspirin On Survival in in Patients Undergoing Chronic Hemodialysis

Study Overview
=================
Brief Summary
-----------------
The aim of present study is to examine the effect of low-dose aspirin on the incidence of cardiovascular events and mortality in patients undergoing chronic hemodialysis.

Detailed Description
-----------------
This study prospectively evaluate the impacts of low dose aspirin on survival and cardio-cerebral vascular events in a large cohort of Chinese patients undergoing chronic hemodialysis. Between January 2008, consecutive patients with hemodialysis with aspirin were enrolled.We examine the association of aspirin with all-cause mortality in patients matched by propensity scores using the Kaplan-Meier method and Cox models in intention-to-treat analyses.The secondary endpoint was rate of cardio-cerebral events.

Official Title
-----------------
The Effect Of Aspirin On Survival in in Patients Undergoing Chronic Hemodialysis

Conditions
-----------------
Hemodialysis

Intervention / Treatment
-----------------
* Drug: acetylsalicylic acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients aged 18 to 85, undergoing chronic hemodialysis, who have none of the following exclusion criteria. Exclusion Criteria: History of gastric or duodenal ulcers Known allergy to aspirin or other NSAIDs -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aspirin group<br>Aspirin 75-100mg,per day，oral | Drug: acetylsalicylic acid<br>* 75-100mg,per day<br>* Other names: Aspirin;|
| No Intervention: non-aspirin group<br>No interventions | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| survival rate |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cardio-cerebral event |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
aspirin
Both Short- and Long-term Outcome Differences According to Patient Frailty

Study Overview
=================
Brief Summary
-----------------
The evaluation for cancer treatment successful has been used by overall survival rate and/or postoperative complications, especially surgical area. Now postoperative QOL has been more importantly required. Therefore this study was conduced to investigate the association between postoperative outcomes and patients frailty.

Official Title
-----------------
Both Short- and Long-term Outcome Differences According to Patient Frailty

Conditions
-----------------
Frailty

Intervention / Treatment
-----------------
* Behavioral: frailty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: surgical patients Exclusion Criteria: a body weight loss of >10% during the 6 months before surgery; the presence of distant metastases; or seriously impaired function of vital organs because of respiratory, renal, or heart disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: frailty|questionaire|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative short-term outcomes | postoperative complications | up to 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative long-term outcomes | survival rate | 5 year |