linjc16/ctgov huggingface dataset:
Diabetes Prevention Program

Study Overview
=================
Brief Summary
-----------------
The Diabetes Prevention Program is a nationwide clinical study to answer the question: Can Type 2 diabetes (also called noninsulin-dependent or adult-onset diabetes) be prevented or delayed? The study has recruited volunteers, who are at high risk of developing diabetes, at twenty-five medical centers in the United States. It is sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health, and other Institute and corporate sponsors. Researchers will evaluate the efficacy of a lifestyle intervention and a pharmacological intervention in preventing or delaying Type 2 diabetes in persons with impaired glucose tolerance (IGT). Each person in the study will be followed for 3 to 6 years.

Conditions
-----------------
Diabetes Mellitus, Non-Insulin-Dependent, Glucose Intolerance

Intervention / Treatment
-----------------
* Behavioral: Intensive lifestyle
* Drug: Metformin
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Impaired glucose tolerance (fasting plasma glucose 95-125 mg/dL and 2hr plasma glucose 140-199 mg/dL) BMI >= 24 kg/m2 Exclusion Criteria: Underlying disease likely to limit life span and/or increase risk of interventions Conditions or behaviors likely to effect conduct of the DPP Diabetes or disordered glucose metabolism Suboptimally treated Thyroid disease Fasting triglyceride level < 600 mg/dl Exclusions related to medications

Ages Eligible for Study
-----------------
Minimum Age: 25 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |
| Active Comparator: Metformin<br> | Drug: Metformin<br> <br> |
| Active Comparator: Intensive Lifestyle<br> | Behavioral: Intensive lifestyle<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of diabetes | Diabetes was diagnosed on the basis of an annual oral glucose-tolerance test or a semiannual fasting plasma glucose test, according to the 1997 criteria of the American Diabetes Association | Up to 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
clinical trial, multi-center, NIDDM, NIDDK, Diabetes Prevention Program (DPP), diabetes risk factors, diabetes, glycemia, cardiovascular risk factors, quality of life, physical activity and nutrition, occurrence of adverse events, insulin secretion and sensitivity, prevention, abnormal glucose metabolism, lifestyle intervention, drug intervention
Study of the Variations of the Blood Pressure After Nephrectomy for Renal Cancer (VAPANCR)

Study Overview
=================
Brief Summary
-----------------
This study evaluates the impact of nephrectomy in renal cancer on blood pressure and renal function. The patients will have a follow-up of their blood pressure and renal function until 6 months after their operation.

Official Title
-----------------
Study of the Variations of the Blood Pressure After Nephrectomy for Renal Cancer

Conditions
-----------------
Renal Cancer, Nephrectomy, Blood Pressure

Intervention / Treatment
-----------------
* Biological: Renin measurement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Nephrectomy programmed for located renal cancer Exclusion Criteria: Patients with metastatic renal cancer Incapacity to use a self-measurement tensiometer Patients treated for high blood pressure Patients with laxative

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: All patients<br> | Biological: Renin measurement<br>* patients will have a blood sample for measuring renin activity<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure change | preoperative and postoperative measurements of blood pressure | One time before the operation and twice after : 1 month and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal function | preoperative and postoperative measurements of renal function with measurements of renin activity and the glomerular filtration rate. | One time before the operation and one after 6 months | 
| Cardiovascular risk | Study the occurence of cardiovascular risk after nephrectomy | A clinical exam will perform before the surgery and 1 month and 6 months after |
Site of Embryo Transfer in Intracytoplasmic Sperm Injection

Study Overview
=================
Brief Summary
-----------------
The technique of embryo transfer is thought to affect the implantation and pregnancy rate .At present, the implantation site can be estimated from the location of the very early gestational sac by transvaginal ultrasound.

Detailed Description
-----------------
Many authors claimed that an increase in implantation and pregnancy rates has been reported to occur when embryos are transferred to the central area of the uterine cavity but there are no studies about the implantation site after using this type of transfer.

Official Title
-----------------
The Correlation Between the Site of Embryo Transfer and the Site of Gestational Sac and Placental Implantation

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Other: Embryo transfer into upper cavity
* Other: Embryo transfer into midcavity


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1- AVF uterus. 2- BMI less than 30 Exclusion Criteria: 1- RVF uterus. 2- BMI more than 30.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ICSI in upper cavity<br>Embryo transfer into the upper cavity | Other: Embryo transfer into upper cavity<br>* Transfer of embryos in upper cavity<br>* Other names: Gestational sac site after embryo transfer;|
| ICSI in midcavity<br>Embryo transfer into the midcavity | Other: Embryo transfer into midcavity<br>* Transfer of embryos in mid cavity<br>* Other names: Gestational sac site after embryo transfer;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of women who will get pregnant in each group | how many women will get pregnant after ICSI in every group | within one month |
New Approaches for the Identification and Characterization of Functional Markers of the Risk of Extension of Breast Cancer Without Lymph Node Involvement

Study Overview
=================
Brief Summary
-----------------
Identify the tissue proteins associated with early breast cancer invasion phases without lymph node involvement . Consider their role in the invasion and the risk of tumor spread .

Conditions
-----------------
Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Breast cancer CCIS Invasive tumors Breast cancer tissues available in the biobank Exclusion Criteria: non availability of cancer tissue specimen
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CCIS<br> | |
| invasive breast cancer<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A list of the ten proteins most associated with early breast cancer invasion phases without lymph node involvement . | The primary objective of this study is to Identify the tissue proteins associated with early breast cancer invasion phases without lymph node involvement. The outcome is a list of identified proteins. | Day 0 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
proteomics
Determinants of Mercaptopurine Toxicity in Paediatric Acute Lymphoblastic Leukemia Maintenance Therapy

Study Overview
=================
Brief Summary
-----------------
The present study was conducted to assess the population pharmacokinetics of 6-mercaptopurine (6-MP) in Pediatric Acute Lymphoblastic Leukemia (ALL) and genetic polymorphisms

Detailed Description
-----------------
The investigators' purpose was to identify genetic factors and metabolite concentrations associated with both hematological toxicity in patients with ALL maintained on 6-MP in Chinese.

Official Title
-----------------
Determinants of Mercaptopurine Toxicity in Paediatric Acute Lymphoblastic

Conditions
-----------------
Acute Lymphoblastic Leukemia

Intervention / Treatment
-----------------
* Drug: Mercaptopurine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients have been diagnosed with Acute Lymphoblastic Leukemia Childhood patients who were undergoing chemotherapy or continuous follow-up after completion of chemotherapy Patients received the phase of maintenance therapy that included oral 6-MP (>4 weeks) and completion of ≥ 6 months according to the CCLG (Chinese Children's Leukemia Group) protocol-ALL 2015 Exclusion Criteria: Patients with high-risk ALL (presence of higher-risk features: MRD ≥ 1% at 46 day, or age < 6 month and white blood cell (WBC) count ≥ 300×109/L with translocations t(9;22) (q34;q11) [BCR-ABL], t(4;11) (q21;q23) [AF4/MLL], t(1;19) (q23;p13) [E2A-PBX1] or other MLL-rearrangements) were removed

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Antitumor drugs<br>Mercaptopurine administered at standard dose for children with hematological neoplasms. | Drug: Mercaptopurine<br>* Dose of mercaptopurine was adjusted to maintain a target white blood cells (WBC) between 2.0-3.0 × 109/L.<br>* Other names: Purinethol;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Red blood cells (RBC) concentration of 6-mercaptopurine (6-MP) | To detect of RBC 6-MP metabolite concentrations and evaluate the association of metabolite concentrations and side effects | at second day after oral administration | 
| Genetic polymorphisms in Chinese patients with ALL | To detect the frequencies of genetic polymorphisms of Chinese patients receiving 6-MP for treatment of ALL | at second day after oral administration |
Clinical Outcomes of Endoscopic Resection for Treating WHYX Lesion

Study Overview
=================
Brief Summary
-----------------
Endoscopically, WHYX cancers demonstrated a vague extent of tumor spread due to pale color changes in both the background atrophic and metaplastic gastric mucosa. However, the clinical outcomes of WHYX cancers after endoscopic resection are unknown. The aim of this study was to evaluate clinical outcomes of WHYX cancers after endoscopic resection.

Official Title
-----------------
Clinical Outcomes of Endoscopic Resection for Treating Extremely Well Differentiated Intestinal-type Adenocarcinoma (WHYX Lesion)

Conditions
-----------------
WHYX Lesion, Extremely Well Differentiated Intestinal-type Adenocarcinoma

Intervention / Treatment
-----------------
* Procedure: WHYX cancer group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: From January 2009 to December 2010 enrolled 872 patients with EGC Exclusion Criteria: EGC with regional lymph node metastasis in radiologic finding endoscopically suspicious submucosal invasion

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: WHYX cancer group<br>WHYX cancer diagnosed by pathologic report | Procedure: WHYX cancer group<br>* WHYX cancer diagnosed by pathologic report<br>|
| Placebo Comparator: non-WHYX cancer group<br>all cancer except WHYX cancer diagnosed by pathologic report | Procedure: WHYX cancer group<br>* WHYX cancer diagnosed by pathologic report<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complete resection rate | Complete resection was defined to have all of the following features: 1. grossly en bloc resection, 2. Tumor-free lateral and vertical resection margins, 3. No lymphovascular invasion, and 5. A depth of submucosal tumor invasion of less than 500 micrometers. | 6 months after endoscopical resection | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
endoscopic feature, complete resection rate, WHYX lesion, endoscopic resection, complete resection, Average size discrepancy
Half-Dose Intracoronary Abciximab Bolus Improves the Mortality Outcome Compared to Standard Intravenous Regimen

Study Overview
=================
Brief Summary
-----------------
The aim of our study was to demonstrate that, during a percutaneous coronary intervention, even smaller amounts of abciximab than standard dose, injected locally, could achieve a rapid thrombus resolution and clinical improvement without concomitant differences in hemorrhagic complications

Detailed Description
-----------------
Patients both with acute myocardial infarction and unstable angina are prone to extensive intracoronary thrombosis, leading to acute deterioration during percutaneous coronary intervention or thrombosis of the device despite therapy. Intracoronary use of abciximab has reported favourable results. We randomly assigned 84 patients to intracoronary half abciximab bolus (group A) and to standard regimen (group B).

Conditions
-----------------
Coronary Disease, Myocardial Infarction

Intervention / Treatment
-----------------
* Drug: abciximab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: presenting with unstable angina presenting with acute myocardial infarction eligibility for percutaneous coronary intervention Exclusion Criteria: presenting with cardiogenic shock

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: abciximab|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
-----------------
angioplasty, stent, abciximab, Platelet Glycoprotein GPIIb-IIIa Complex, myocardial infarction
The Feasibility and Safety of Head-up Cardiopulmonary Resuscitation in Patients With Non-traumatic Cardiac Arrest

Study Overview
=================
Brief Summary
-----------------
Head up CPR with impedance threshold device(ITD) and active compression-decompression (ACD) has been proved to improve both cerebral and coronary perfusion pressure during resuscitation in animal models. Increased rates of Spontaneous Circulation (ROSC) were also observed in cardiac arrest patients. The goal of this clinical trial is to learn about the feasibility and safety of Head-up Cardiopulmonary Resuscitation in patients with non-traumatic cardiac arrest. Participants will be received head-up CPR during resuscitation. The main question it aims to answer is if there is any adverse or unfavorable event during resuscitation.

Official Title
-----------------
The Feasibility and Safety of Head-up Cardiopulmonary Resuscitation in Patients With Non-traumatic Cardiac Arrest: Single Center Research

Conditions
-----------------
Cardiac Arrest

Intervention / Treatment
-----------------
* Device: Head-up Cardiopulmonary Resuscitation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Non-traumatic cardiac arrest Age ≥ 20 Exclusion Criteria: Trauma Age < 20 Pregnancy Irreversible death (e.g. liver mortis, rigor mortis, decapitation, transection and decomposition) Disorder of cervical spine

Ages Eligible for Study
-----------------
Minimum Age: 20 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Head-up Cardiopulmonary Resuscitation<br> | Device: Head-up Cardiopulmonary Resuscitation<br>* Elevate patient's head to 30 degrees by EleGARD System during cardiopulmonary resuscitation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and portion of participants with serious or non-serious adverse event | e.g. event of fall, failure of intubation | Up to 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and portion of participants with repeated CPR |  | up to 1 day | 
| Number and portion of participants with survival to emergency department discharge |  | up to 1 day | 
| Number and portion of participants with sustained return of spontaneous circulation | sustained ROSC ≥ 20 minutes | Up to 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cardiac arrest, Head-up Cardiopulmonary Resuscitation
Study Evaluating Gemtuzumab Ozogamicin in Acute Myeloid Leukemia

Study Overview
=================
Brief Summary
-----------------
The primary objectives are a) to establish the maximum tolerated dose of gemtuzumab ozogamicin in combination with cytarabine and b) to assess the safety of gemtuzumab ozogamicin when given concurrently with cytarabine.

Official Title
-----------------
A Dose Ranging Study of the Safety and Efficacy of Gemtuzumab Ozogamicin (GO) Given in Combination With Cytarabine in Relapsed or Refractory Patients and Alder De Novo Patients With Acute Myeloid Leukemia.

Conditions
-----------------
Acute Myeloid Leukemia

Intervention / Treatment
-----------------
* Drug: Gemtuzumab Ozogamicin
* Drug: cytarabine.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Morphologic diagnosis of AML from bone marrow aspirate and biopsy Flow cytometry, performed at the study site, must demonstrate that the patient has AML that is CD33+, based on local laboratory criteria Age 18 years or older for relapsed or refractory patients for Phase I of this study Exclusion Criteria: Patients with de novo AML of the M3 subtype AML following an antecedent hematologic disorder (myelodysplasia or myeloproliferation) of > 2 months duration AML secondary to exposure to chemotherapy or radiation

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Gemtuzumab Ozogamicin|nan|
|Drug: cytarabine.|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Substrate Metabolism and Insulin Sensitivity in Acromegalic Patients Before and After Treatment

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the effects of chronic elevated growth hormone on metabolism and insulin sensitivity by studying acromegalic patients before and after treatment.

Official Title
-----------------
Substrate Metabolism and Insulin Sensitivity in Acromegalic Patients Before and After Treatment

Conditions
-----------------
Acromegaly, Excessive Growth Hormone Secretion, Insulin Resistance

Intervention / Treatment
-----------------
* Procedure: Transsphenoidal adenomectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written consent Age between 18 and 70 Recently diagnosed with acromegaly Exclusion Criteria: NYHA 3 Uncontrolled hypertension Known cerebrovascular disease Proliferative retinopatia

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Patients recently diagnosed with acromegaly | Procedure: Transsphenoidal adenomectomy<br>* Surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin sensitivity |  | Before and after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QoL, body composition, intrahepatic and intramyocellular fat, substrate metabolism, Glucose tolerance |  | Before and after treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acromegaly, Growth Hormone, Insulin resistance, Glucose tolerance, Body Composition, Substrate metabolism