linjc16/ctgov huggingface dataset:
Assessing Supported Employment With Veterans With Felony Convictions and Mental Illness or Substance Abuse

Study Overview
=================
Brief Summary
-----------------
This study continues to develop and refine best practices in the delivery of vocational services to veterans with histories of felony convictions and mental health/substance abuse difficulties. There are currently over 225,000 incarcerated veterans and it is estimated 64,000 veterans are released from prisons annually. These veterans encounter significant difficulties in finding employment due to stigma, intrapersonal difficulties, and out-dated work skills. Additionally these veterans are more likely to be homeless than other population., Previous work has found that manual based, vocational groups led by trained vocational staff led to quicker employment compared to traditional vocational services and manual based self studies. To attempt to improve on previous results, this study adds principles and components of supported employment including ongoing follow-up, treatment team coordination, and community based assistance.

Official Title
-----------------
Assessing Supported Employment With Veterans With Felony Convictions and MI or SA

Conditions
-----------------
Employment

Intervention / Treatment
-----------------
* Other: Group vocational intervention
* Other: Supported Employment Condition


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: history of at least one felony conviction diagnosis of a mental illness including substance use disorders Exclusion Criteria: dementia active psychosis

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group Based Vocational Rehabilitation<br>Group vocational intervention | Other: Group vocational intervention<br>* Group based manualized vocational rehabilitation<br>|
| Experimental: Supported Employment Condition<br>Group vocational intervention + supported employment | Other: Supported Employment Condition<br>* Veterans in this condition will receive a proven group based manualized vocational rehabilitation intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Employment | Number of veterans finding work within 6 months | within 6 months | 
| Total Employment | Total amount employed over 1 year follow-up period | 1 years |
The Standard Concentration of Morphine as a Positive Control for Intradermal Skin Test

Study Overview
=================
Brief Summary
-----------------
This study aims to compare skin reactivity results between morphine and histamine as a positive control agents in intradermal skin test.

Detailed Description
-----------------
Histamine hydrochloride and different concentrations of morphine sulfate will be intradermally injected and wheal diameter size will be comparatively measured between 15-30 minutes' time points after the test.

Official Title
-----------------
The Standard Concentration of Morphine as a Positive Control for Intradermal Skin Test

Conditions
-----------------
Intradermal Test

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18-60 years old Exclusion Criteria: immunodeficiency state cancer severe skin diseases severe medical illnesses malnutrition uncontrolled asthma pregnancy received oral or systemic corticosteroid within 1 month before this study receiving immunosuppressive agents taken antihistamine within 3 days before this study taking beta-blocker previous history of immunotherapy have hypersensitivity reaction to morphine/opiates

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wheal diameter from morphine skin test at different concentrations compared to standard histamine between 15-30 minutes after skin test |  | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effects |  | 24 hours |
Expanded Access to Veliparib

Study Overview
=================
Brief Summary
-----------------
This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to veliparib prior to approval by the local regulatory agency. Availability will depend on territory eligibility. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria. EAP is also available for other indications where there is reasonable scientific basis for efficacy.

Detailed Description
-----------------
Expanded Access

Official Title
-----------------
Expanded Access to Veliparib

Conditions
-----------------
Solid Tumors With Documented BRCA, BARD, or PALB or Other Acceptable DNA Mutations or Anomalies That Are Scientifically Sound, Triple Negative Breast Cancer (TNBC), High Grade Serous Ovarian Cancer, Patients Requiring Veliparib Suspension Formulation

Intervention / Treatment
-----------------
* Drug: Veliparib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient has relapsed/refractory disease and exhausted all standard treatments. The patient has documented Breast Cancer (BRCA), BRCA associated RING domain (BARD), or Partner and Localizer of Breast Cancer (PALB) or other acceptable deoxyribonucleic acid (DNA) mutations. Exclusion Criteria: The patient is eligible for a Poly Adenosine diphosphate ribose polymerase (PARP) inhibitor clinical trial. The patient has previously received a PARP inhibitor for the same disease.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Veliparib|Veliparib will be administered orally.|

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
-----------------
Expanded Access, Pre-approval Access, Compassionate Use, Special Access Program, Named Patient Basis, Special Access Scheme
Study of NGM313 in Obese Participants

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaulate the safety, tolerability, and efficacy of NGM313 in obese participants

Official Title
-----------------
A Phase 1B, Single Center, Randomized, Open Label, Parallel Group Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single NGM313 Dose or Daily Oral Pioglitazone in Obese Participants With Insulin Resistance and Increased Liver Fat

Conditions
-----------------
Obese

Intervention / Treatment
-----------------
* Biological: NGM313
* Drug: Pioglitazone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body mass index (BMI) of 30-43 kg/m2 Waist circumference > 40 inches in males or > 30 inches in females Normal ECG readings Exclusion Criteria: Significant history or clinical manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder History of any known Congestive heart failure (CHF) History of macrovascular disease

Ages Eligible for Study
-----------------
Minimum Age: 21 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NGM313<br> | Biological: NGM313<br>* Subcutaneous injection<br>|
| Active Comparator: Pioglitazone<br> | Drug: Pioglitazone<br>* White to off-white round tablet<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of whole body insulin sensitivity measured as insulin sensitivity index (M and Si) following intravenous insulin administration |  | 28 Days |
Derivation of New Human Embryonic Stem Cell Lines: Identification of Instructive Factors for Germ Cells Development

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is To generate human embryonic stem cells lines (hESC) lines Study of the factors that contribute to differentiation towards germ cell.

Official Title
-----------------
Basic Research. Unveiling Factors That Contribute to Germ Cell Differentiation

Conditions
-----------------
Normal Healthy Embryos

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: any donated embryos Exclusion Criteria: not relevant

Ages Eligible for Study
-----------------
Minimum Age: 2 Days
Maximum Age: 4 Days

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Donated embryos<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| New hESC | Donated embryos will be used for derivation of the Es cells | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Factors that contribute to germ cells differentiation | We shall employ the knowledge from a study of sperm differentiation in mice to instruct the differentiation of ES cells towards germ cells | 4 years |
Adolescent and Young Adulte Scoliosis

Study Overview
=================
Brief Summary
-----------------
Thoracic hypocyphosis and greater lumbar lordosis after correction of idiopathic scoliosis in adolescents and young adults may adversely affect overall sagittal alignment and increase the risk of proximal junctional kyphosis. The objective of this study is to analyze surgical corrections and maintenance of correction over time using modern posterior instrumentation strategies by comparing technical developments.

Official Title
-----------------
Analysis of Corrections of Adolescent and Young Adulte Scoliosis by Posterior Instrumentation

Conditions
-----------------
Idiopathic Scoliosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Major subjects> 18 years old Subject with a surgical indication for arthrodesis and surgical correction of adolescent or young adult scoliosis Subject not having expressed his opposition, after information, to the reuse of his data for the purposes of this research. Exclusion criteria: Subject having expressed opposition to participating in the study Subject under guardianship or guardianship Subject under safeguard of justice

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study of corrections of adolescent and young adult scoliosis by posterior instrumentation |  | Files analysed retrospectively from January 01, 2010 to December 31, 2020 will be examined] | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Idiopathic scoliosis, Thoracic hyperkyphosis, Cyphosis
Proteome- and Methylation Profiles in Oropharyngeal Cancer

Study Overview
=================
Brief Summary
-----------------
This clinical study aims to evaluate proteome- and methylation profiles in saliva in patients with oropharyngeal cancers

Official Title
-----------------
Proteome- and Methylation Profiles in Oropharyngeal Cancer

Conditions
-----------------
Oropharynx Cancer

Intervention / Treatment
-----------------
* Diagnostic Test: Examination of saliva


Participation Criteria
=================
Eligibility Criteria
-----------------
Cancer group: Inclusion Criteria: Written informed consent Verified oropharyngeal squamous cell carcinoma Exclusion Criteria: Other active cancer Uncontrolled comorbidity Unable to give informed consent Control group: Inclusion Criteria: Written informed consent Normal ENT examination Exclusion Criteria: Active cancer Uncontrolled comorbidity Unable to give informed consent

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cancer group<br> | Diagnostic Test: Examination of saliva<br>* Collection of saliva samples<br>|
| Control group<br> | Diagnostic Test: Examination of saliva<br>* Collection of saliva samples<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in proteome and methylation profiles | Differences between cancer- and control group | At diagnosis |
Recommendations for the Treatment of Children With Burkitt's Lymphoma

Study Overview
=================
Brief Summary
-----------------
This is the 4th LMB study by the French African Pediatric Oncology Group (GFAOP). The study hopes to be able to evaluate children earlier with stage I and II disease and to evaluate treatment response earlier so that the units can decide if a change in treatment is necessary, it is also hoped to provide an intensification of treatment for the stage IV disease.

Detailed Description
-----------------
This is the 4th Burkitt's Lymphoma (LMB) study by the GFAOP group. This study hopes to include at least 14 Sub Saharian countries some of whom have never participated in a LMB study. The evaluation of improvement in early diagnosis should be possible in this study. The study hopes to be able to evaluate children earlier, with stage I and II disease and to evaluate treatment response earlier so that the units can decide if a change in treatment is necessary, it is also hoped to provide an intensification of treatment for children with a stage IV disease.

Official Title
-----------------
Recommendations for the Treatment of Children With Burkitt's Lymphoma

Conditions
-----------------
Burkitt Lymphoma

Intervention / Treatment
-----------------
* Other: OBSERVATIONAL


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of Burkitt's Lymphoma: all location. Diagnosis by cytology or histology. Not possible to follow all the treatment. - Exclusion Criteria: Not a B Cell tumor. Child has been previously treated. Child has also another illness which would render the treatment incompatible. Parents refusal.

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: OBSERVATIONAL|OBSERVAITON OF THE CAPACITY OF THE GROUP TO TREAT ACCORDING TO THE PROTOCOLE AND LOOK AT OUTCOME FOR STAGE I AND II DISEASE|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the number of cases with local disease. | evaluating the initial clinical reports and later histological reports to confirm the diagnosis and the stage. | 5 years | 
| Evaluation of the number of cases by stage at the time of diagnosis. | evaluating the initial clinical reports and later histological reports to confirm the stage and the diagnosis. | 5 Years | 
| Evaluating the treatment given. | Comparison of treatment given and recommended treatment. | 5 Years | 
| Evaluating the follow up after treatment. | How many children alive or dead after treatment | 5 Years | 
| Number of relapse cases | The evaluation and the treatment of relapse and outcome | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Application of therapeutic recommendations | Evaluations of the correct application of recommendations | 5 years |
Comparison of Two Different Medications Used to Treat Elevated Intracranial Pressure

Study Overview
=================
Brief Summary
-----------------
The overall purpose of this study is to compare the effects of mannitol and hypertonic saline on patients with increased intracranial pressure. The hypothesis being tested is that hypertonic saline is more effective in controlling increased intracranial pressure than mannitol.

Official Title
-----------------
Prospective, Randomized Clinical Trialto Compare Mannitol and Hypertonic Saline for Treatment of Increased Intracranial Pressure

Conditions
-----------------
Increased Intracranial Pressure

Intervention / Treatment
-----------------
* Drug: Hypertonic Saline, Mannitol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documented SAH (by computed tomography or lumbar puncture), ICH, TBI or brain tumor Patient greater than or equal to 18 years of age ICP monitor in place ICP greater than 20mmHg, not related to a transient noxious stimulus and not responding to standard measures for controlling ICP (ventricular drainage, elevation of head of the bed and optimizing PaCO2) Patient or patient's legally authorized representative has provided written informed consent Exclusion Criteria: Patient less than 18 years of age Lack of ICP monitoring Patient received Mannitol prior to placement of ICP monitor Baseline serum osmolarity of greater than 310 mOsm/L Patient is currently enrolled in another investigational drug or device study Congestive heart failure at time of enrollment Chronic renal failure on hemodialysis Pregnancy

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Hypertonic Saline, Mannitol|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of ICP below treatment threshold (less than 20 mmHg) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare effects of each treatment on MAP, CPP, serum and urine sodium and osmolality |  |  |
Meta-analysis in Post-marketing Surveillances for SGLT2 Inhibitors in Patients With Type 2 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to integrate the post-marketing surveillances data (Specified use-results surveys on long-term treatment) of the 6 SGLT2 inhibitors approved or applied in Japan and to evaluate the safety and efficacy of long-term use of each under actual clinical practice conditions. In each post-marketing surveillance, 3000 patients who complete a 3 years treatment are enrolled. A total of 18000 patients are assessed in the meta-analysis.

Official Title
-----------------
Meta-analysis in Post-Marketing Surveillances for Long-Term Drug Use of SGLT2 Inhibitors in Patients With Type 2 Diabetes Mellitus

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

Intervention / Treatment
-----------------
* Drug: SGLT2 Inhibitors


Participation Criteria
=================
Eligibility Criteria
-----------------
Patients with Type 2 diabetes mellitus starting medication of SGLT2 inhibitors
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: SGLT2 Inhibitors|Ipragliflozin (Suglat®), Dapaglilozin (Forxiga®), Tofogliflozin (Deberza® / Apleway®), Luseogliflozin (Lusefi®), Canagliflozin (Canaglu®), Empagliflozin (Jardiance®)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events |  | up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of cardiovascular events |  | up to 3 years | 
| Incidence of cancer |  | up to 3 years | 
| The change from baseline in vital signs and laboratory data |  | Baseline and 3 months, 6 months, 1 year, 2 years, 3 years after administration | 
| Incidence of other adverse events |  | up to 3 years | 
| Incidence of drug-related adverse events |  | up to 3 years | 
| Incidence of serious adverse events |  | up to 3 years | 
| The change from baseline in HbA1c |  | Baseline and 3 months, 6 months, 1 year, 2 years, 3 years after administration | 
| The change from baseline in Fasting Plasma Glucose |  | Baseline and 3 months, 6 months, 1 year, 2 years, 3 years after administration |