linjc16/ctgov huggingface dataset:
Lung Cancer Mutation Consortium Protocol

Study Overview
=================
Brief Summary
-----------------
The primary objective of this protocol is to determine the frequency of oncogenic mutations in 1000 patients with advanced adenocarcinoma of the lung. The linked clinical and mutational analyses will be used to determine the frequency of each mutation, its association with clinical features and outcome, and its association with other mutations. As future therapeutic protocols specific for these mutations are developed, patients may be notified of their eligibility for these studies. Future translational studies may be used to: a) unravel the complex biology of lung cancer; b) identify prognostic markers; c) define predictive markers of response/resistance to new therapies; d) identify new targets. A secondary goal is to establish a consortium of sites that have the capability of conducting multiple mutation testing in a Clinical Laboratory Improvement Amendments (CLIA) certified lab.

Official Title
-----------------
Lung Cancer Mutation Consortium Protocol

Conditions
-----------------
Adenocarcinoma of Lung, Stage IV

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects (=> 18 years of age) who are undergoing further evaluation for the diagnosis or treatment of advanced adenocarcinoma of the lung. Diagnosed May 2012 or later Oral and written informed consent. Exclusion Criteria: Lung cancer histologies other than adenocarcinoma Lack of adequate tissue.

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 |
| --- | --- |
| Advanced Adenocarcinoma<br>Stage IV adenocarcinoma who have undergone biopsy with remnant tissue. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of oncogenic mutations in patients with advanced adenocarcinoma of the lung. | The primary objective of this protocol is to determine the frequency of oncogenic mutations in patients with advanced adenocarcinoma of the lung. | Five years | 
| Rate of oncogenic mutations in patients with advanced adenocarcinoma of the lung. | The primary endpoint of this protocol is the mutation rate. | Five years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Associations between each mutation and clinical outcomes. | The secondary objectives of this protocol are to study the associations between each mutation and clinical outcomes, e.g., survival, clinical features, e.g. smoking status, age, and other mutation. | Two years |
Critical Limb Ischemia and Transcutaneous Oximetry

Study Overview
=================
Brief Summary
-----------------
Retrospective analysis of transcutanesou oximetry (Tcpo2) recording for patients referred with suspected critical limb ischemia searching for specific changes in TcpO2 patterns.

Detailed Description
-----------------
Patients had Tcpo2 recording at the suspected limb and chest level at rest in the lying position. Provocative tests (leg elevation, leg lowering, oxygen inhalation) were performed to improve the sensitivity of tests. TcpO2 results were recorded on a 1 Hz bais for of line analysis after anonymization. We recorded age , gender, weight, height, ongoing treatments , History of cardiac or respiratory disease. Visual and mathematical analysis of the TcpO2 recording at the chest and limb level searching for various indices of TcpO2 variability at rest, or differences in responses between the chest and limb tcpO2 responses to provocative tests..

Official Title
-----------------
Oximetrie Transcutanee et Ischemie Critique

Conditions
-----------------
Critical Limb Ischemia

Intervention / Treatment
-----------------
* Diagnostic Test: transcutaneous oxygen pressure recording at rest


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Referral for suspected critical limb ischemia Exclusion Criteria: Absence of recording, deny to use medical file

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 |
| --- | --- |
| Suspected critical limb ischemia<br>Patients referred for transcutaneous oxygen pressure measurements due to a clinical suspicion of critical limb ischemia | Diagnostic Test: transcutaneous oxygen pressure recording at rest<br>* Recording of limb and chest transcutaneous oxygen pressure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variability of TcpO2 | Study of TcpO2 variability | 1 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
transcutaneous oxygen pressure
The Effect of DHEA on Markers of Ovarian Reserve in Women With Diminished Ovarian Reserve

Study Overview
=================
Brief Summary
-----------------
This prospective study evaluates the effect of DHEA supplementation on markers of ovarian reserve in women with diminished ovarian reserve.

Detailed Description
-----------------
Ovarian reserve markers, such as FSH, estradiol, AMH, ovarian volume and antral follicle counts will be monitored on DHEA supplementation in a prospective fashion.

Official Title
-----------------
The Effect of DHEA on Markers of Ovarian Reserve in Women With Diminished Ovarian Reserve

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

Intervention / Treatment
-----------------
* Dietary Supplement: dehydroepiandrosterone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: infertile women with diminished ovarian reserve Exclusion Criteria: women > 45

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 44 Years

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

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 |
| --- | --- |
| Other: Dehydroepiandrosterone<br>infertile women with low anti mullerian hormone levels | Dietary Supplement: dehydroepiandrosterone<br>* DHEA supplementation 25 mg tid for 3 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| live birth rate | Live birth rate will be monitored for women who took DHEA supplementation | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of oocytes | Number of retrieved oocytes for patients undergoing IVF will be monitored along with ovarian response | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ovarian reserve, FSH, anti-mullerian hormone, estradiol, oocyte, IVF, embryo transfer
The Effect of Share Care Model in the Improvement of Diabetes Management

Study Overview
=================
Brief Summary
-----------------
The situation of diabetes management in China is serious. To set up hierarchical medical system is necessary, though there was no mature or effective diabetes management model in the mainland. To explore a new path for hierarchical medical system, we would localize the share care model of diabetes management in Taiwan. Diabetic experts, diabetic educators and community doctors would use interactive information platform and self-glucose monitor with application on mobile phone to manage diabetic patients together. The model will be applied in six diabetic centers, and patients we will be managed in the new model and followed, and at the same time patients that managed in the conventional model in the real world, the differences of proportion who achieve a composite goal will be compared yearly for 5 years.

Official Title
-----------------
The Effect of Share Care Model in the Improvement of Diabetes Management

Conditions
-----------------
Diabetes Mellitus, Type 2

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetic patients Exclusion Criteria: Patients had not signed the consent form Patients with sever hart failure, hepatic failure, renal failure

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| common care group<br>diabetic patients under common care group | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c | control rate of HbA1c<7.0% | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood pressure | control rate of blood pressure<140/90 millimetres of mercury | 1 year | 
| LDL-C | control rate of LDL-C<2.6mmol/L | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes mellitus, Diabetic management, Share care
Bupropion for the Treatment of Methamphetamine Dependence - 1

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the efficacy and safety of bupropion in reducing methamphetamine use in subjects with methamphetamine dependence

Detailed Description
-----------------
A double-blind, placebo-controlled, parallel-group design study in which 100 subjects will be randomly assigned to placebo or bupropion for 12 weeks with follow-up assessments 4 weeks following treatment. Adaptive randomization will be used to balance treatment groups based on gender.

Official Title
-----------------
Bupropion for the Treatment of Methamphetamine Dependence

Conditions
-----------------
Amphetamine-Related Disorders

Intervention / Treatment
-----------------
* Drug: Bupropion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject must have methamphetamine dependence as determined by the DSM-IV diagnosis Subject must be willing to comply with study procedures. Ability to verbalize understanding of consent form, provide written consent, and verbalize willingness to complete study procedures Be able to comply with protocol requirements Exclusion Criteria: Please contact site for more information.

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity addiction |  |  | 
| Methamphetamine use |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
amphetamine dependence
Neuromuscular Electrical Stimulation Cycling

Study Overview
=================
Brief Summary
-----------------
A new electromyography (EMG)-driven neuromuscular electrical stimulation (NMES)-cycling system is introduced to stroke survivors for lower-limb rehabilitation. The system will generate NMES to targeted muscle according to the user's voluntary intention, represented by the EMG signal during cycling.

Official Title
-----------------
Interactive Cycling System Using Electromyography (EMG)-Driven Neuromuscular Electrical Stimulation (NMES) for Rehabilitation

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Device: lower-limb cycling system


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of ischemic brain injury or intracerebral hemorrhage shown by magnetic resonance imaging or computed tomography after the onset of stroke; sufficient cognition to follow simple instructions as well as understand the content and purpose of the study; significant gait deficit (Functional Ambulatory Category, FAC, scale <4 [person cannot walk independently]). Exclusion Criteria: any additional medical or psychological condition that would affect their ability to comply with the study protocol, e.g., a significant orthopedic or chronic pain condition, major post-stroke depression; severe hip, knee or ankle contracture that would preclude passive range of motion of the leg; implanted cardiac device (e.g. pacemaker and internal defibrillator).

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EMG-driven NMES<br>subjects will receive EMG-driven NMES cycling exercise. | Device: lower-limb cycling system<br>* patients will receive 30-minute cycling exercise<br>|
| Placebo Comparator: passive pre-programmed NMES<br>subjects will receive passive pre-programmed NMES during cycling exercise. | Device: lower-limb cycling system<br>* patients will receive 30-minute cycling exercise<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lower-Extremities Fugl-Meyer Assessment |  | 3-month follow up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Elderly Mobility Scale |  | 3-month follow up | 
| Berg Balance Scale |  | 3-month follow up | 
| 6-Minute Walking Test |  | 3-month follow up | 
| 10-Meter Walk Test |  | 3-month follow up | 
| electroencephalography |  | 3-month follow up |
Evaluation of Pharmacogenetic Testing In a Mental Health Population and Economic Outcomes

Study Overview
=================
Brief Summary
-----------------
This is a non-randomized, single-case design of pharmacogenetic implementation in a mental health patient population of subjects taking antipsychotics and/or antidepressants.

Detailed Description
-----------------
This is a non-randomized, single-case design of pharmacogenetic implementation in a mental health patient population of subjects taking antipsychotics and/or antidepressants. Retrospective and prospective data will be collected on all subjects before and after pharmacogenetic recommendations have been made. Retrospective data will be collected for the previous 12 months before pharmacogenetic recommendations are made and prospective data will be collected for 12 months after pharmacogenomic recommendations have been made.

Official Title
-----------------
Evaluation of Pharmacogenetic Testing In a Mental Health Population and Economic Outcomes

Conditions
-----------------
Major Depressive Disorder 1

Intervention / Treatment
-----------------
* Genetic: Pharmacogenetic testing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be taking either an anti-depressant or an anti-psychotic medication Must provide informed consent Must have Avera Health Plans insurance coverage Must have three months of participation in the Avera Care Coordination Program Exclusion Criteria: Must not be pregnant or breastfeeding Must not have an active and/or unstable diagnosis of substance abuse Must not have a primary diagnosis of dementia, bulimia, or anorexia nervosa disorder Must not have had a previous pharmacogenetic evaluation

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 |
| --- | --- |
| Care Coordination Group<br>Patients participating in the Avera Care Coordination Program for Intervention 'Pharmacogenetic testing' | Genetic: Pharmacogenetic testing<br>* Psychotropic genotyping panel<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depression scores | Compare depression scores at baseline and following pharmacogenetic-guided medication recommendation | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Economic impact of pharmacogenetic testing | Data from patients' insurance provider will be compared pre- and post-pharmacogenetic testing. Such data may include hospitalizations, clinic visits, ER visits, medication expenses, etc. | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
depression, Major Depressive Disorder, MDD, mental health, pharmacogenomics, personalized medicine, precision medicine, anti-depressants
Peri-operative Prediction of Prolonged Stay in the Cardiac Intensive Care Unit for Adult Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to create a model using intra-operative modified SOFA score and peri-operative clinical factors to predict prolonged stay in the cardiac intensive care unit (CICU) for adult cardiac surgery with heart-lung machine

Detailed Description
-----------------
Cardiac surgery using cardiopulmonary bypass (CPB) is commonly associated with a systemic inflammatory response that exacerbates peri-operative life-threatening complications and multiple organ dysfunction syndromes. These features can prolong the stay in the CICU. Many peri-operative clinical risk factors contribute to those adverse outcomes resulting in prolonged CICU stay. If the investigators can create a model to identify the effects of these intra-operative clinical risk factors to prolonged CICU stay

Official Title
-----------------
Peri-operative Prediction of Prolonged Stay in the Cardiac Intensive Care Unit for Adult Cardiac Surgery With Cardiopulmonary Bypass

Conditions
-----------------
Heart; Dysfunction Postoperative, Cardiac Surgery, Cytokine Release Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients who had undergone elective cardiac surgery with CPB Exclusion Criteria: under 18 years of age needing emergency surgery needing intra-aortic balloon pump

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients with elective cardiac surgery<br>adult patients who had undergone elective cardiac surgery with CPB | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adjusted odds ratio of peri-operative clinical risk factors in prolonged CICU patients | Blood samples were collected for cytokines investigation and leukocyte counts. Clinical scoring systems , major peri-operative clinical risk factors were calculated and recorded at each time point. Univariate odds ratio were calculated for each factors for prolonged CICU stay. Those significant factors were included in logistic regression model for analysis of adjusted odds ratios. Then, a model for prolonged CICU stay is constructed. | 24 hours after CPB | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cardiac surgery, cytokine, clinical scoring system, risk factor
Hepatitis B Virus Vertical Transmission From HIV-HBV Co-infected Women

Study Overview
=================
Brief Summary
-----------------
Vertical HIV transmission has been dramatically reduced by the use of combined antiretroviral therapy in HIV-infected pregnant women. Among the most often used drugs, several have dual activity, against HIV and HBV: lamivudine, emtricitabine, tenofovir. Studies about vertical HBV transmission from HIV-HBV co-infected pregnant women are rare in developed countries. The study hypothesis is a major reduction of the risk of HBV vertical transmission.

Detailed Description
-----------------
Mother-to-Child HIV transmission has been dramatically reduced by the use of combined antiretroviral therapy in HIV-infected pregnant women, both in developed and in developing countries. Among the most often used drugs, several have dual activity, against HIV and HBV: lamivudine, emtricitabine, tenofovir; they can be used as a combo, as tenofovir+emtricitabine for instance. Studies about vertical HBV transmission from HIV-HBV co-infected pregnant women are rare in developed countries. The study hypothesis is a major reduction of the risk of HBV vertical transmission in this context, justifying this retrospective study.

Official Title
-----------------
Prevention of Hepatitis B Virus Mother-to-Child Transmission (MTCT) From HIV-HBV Co-infected Pregnant Women by Use of Nucleosides/Nucleotides Analogues With Dual Activity During Pregnancy.

Conditions
-----------------
Vertical Disease Transmission, HBV

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children born in the Maternity Department from HIV-HBV co-infected women whose mother was given a treatment with dual activity (HIV and HBV) during pregnancy Exclusion Criteria: no

Ages Eligible for Study
-----------------
Minimum Age: 9 Months
Maximum Age: 15 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 |
| --- | --- |
| children born from HIV-HBV women<br>Studying retrospectively their status for HBs Ag and HBc Ab | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hepatitis B sAg status in children born from HIV-Hepatitis B Virus co-infected women |  | up to 10 years (expected average: 5 years) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibodies (Ab) against Hepatitis B core antigen in children |  | up to 10 years (expected average: 5 years) |