linjc16/ctgov huggingface dataset:
Study of DS-1001b in Patients With Gene IDH1-Mutated Gliomas

Study Overview
=================
Brief Summary
-----------------
This is a study to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and anti-tumor activity of DS-1001b in patients with gliomas that harbor IDH1-R132 mutations.

Official Title
-----------------
A Phase 1 Study of DS-1001b in Patients With IDH1 Mutated Gliomas

Conditions
-----------------
Glioma

Intervention / Treatment
-----------------
* Drug: DS-1001b


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Has histologically confirmed glioma with an IDH1-R132 mutation Has disease that has recurred or progressed following standard treatment including radiotherapy Has measurable lesion(s) as per RANO criteria Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 Exclusion Criteria: Has significant symptoms of increased intracranial pressure Has another active neoplasm Has active infection requiring systemic treatment Has a history of severe cardiac disease Has had prior treatment with any inhibitor targeting mutant IDH1 Has had investigational drug treatment within 4 weeks prior to the first dose of study treatment Is a pregnant or lactating female

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Drug DS-1001b<br>Oral administration | Drug: DS-1001b<br>* Generic not assigned<br>* Other names: Investigational;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants with dose limiting toxicities |  | 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants experiencing an adverse event (AE) | AEs temporally associated with DS-1001b treatment | up to 36 months | 
| Area under the concentration curve (AUC) for DS-1001b |  | up to 36 months | 
| Maximum plasma concentration (Cmax) for DS-1001b |  | up to 36 months | 
| Time to maximum plasma concentration (Tmax) for DS-1001b |  | up to 36 months | 
| Change from baseline in 2-hydroxyglutarate (2-HG) concentration in patient specimens after treatment with DS-1001b |  | Baseline, up to 36 months | 
| Tumor response to DS-1001b based on Response Assessment in Neuro-Oncology Criteria (RANO) |  | up to 36 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
DS-1001b, IDH1 mutation, Developmental Phase I, Glioma
Expanded Access to Provide SUVN-502 for the Treatment of Subjects With Alzheimer's Disease

Study Overview
=================
Brief Summary
-----------------
This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to SUVN-502 for the treatment of Alzheimer's Disease. Investigator as well as the subject/caregiver must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the patient's medical history and program eligibility criteria. Subjects will not be evaluated for efficacy and safety during the expanded access.

Official Title
-----------------
An Intermediate-Size, Expanded Access to SUVN-502 for the Treatment of Subjects With Alzheimer's Disease Who Have Completed the CTP2S1502HT6 Study

Conditions
-----------------
Alzheimer Disease, Dementia, Cognition Disorders

Intervention / Treatment
-----------------
* Drug: SUVN-502


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who have completed the 30 week treatment period of study CTP2S1502HT6 as planned and wish to continue treatment with SUVN-502. Subject (or subject's legally acceptable representative) and caregiver must sign the Informed Consent Form (ICF) to participate in the study. Exclusion Criteria: Has participated or is participating in any other clinical (investigational) study after completion of CTP2S1502HT6 study. Is treated or likely to require treatment during the study with any medication prohibited by this expanded access program.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 85 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: SUVN-502|Tablet|

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
-----------------
SUVN-502, Expanded Access
Drug Interaction Study Between AZD3480 and Warfarin

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate if AZD3480 and warfarin interact with each other or not, i.e. show the same or altered plasma concentration profiles when co-administered compared to administered alone.

Official Title
-----------------
A Single-Centre, Double Blind, Randomized, Two-Way Cross-Over Study of Repeated Doses of AZD3480 and Single Dose of Warfarin to Evaluate the Pharmacokinetic Interaction of AZD3480 and Warfarin and the Effect of AZD3480 Pharmacodynamic in Healthy Male Subjects (Phase I

Conditions
-----------------
Alzheimer's Disease

Intervention / Treatment
-----------------
* Drug: AZD3480
* Drug: Placebo
* Drug: Warfarin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provision of signed written informed consent Clinically normal physical findings and laboratory values Exclusion Criteria: Clinically significant illness or clinically relevant trauma within three weeks before the first dose History of clinically significant disease Use of prescribed medication during the 2 weeks before administration of the first dose of investigational product

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>AZD3480 + warfarin | Drug: AZD3480<br>* AZD3480 capsules qd, 12 days<br>Drug: Warfarin<br>* Warfarin: single dose on day 6<br>|
| Experimental: 2<br>Placebo+ warfarin | Drug: Placebo<br>* Placebo capsules qd, 12 days<br>Drug: Warfarin<br>* Warfarin: single dose on day 6<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK variables |  | Frequent sampling occasions during days 5 and 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety variables (adverse events, blood pressure, pulse, safety lab) |  | During the whole treatment period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AZD3480, Warfarin, Drug interaction
Influencing Factors on Gait Variability in PD

Study Overview
=================
Brief Summary
-----------------
The principal motor features of Parkinson's disease (PD) include rigidity, tremor, bradykinesia, and postural instability. These motor deficits might cause gait dysfunction including reduced gait velocity, stride length, arm swing, and increased gait variability. Among these, increase in gait variability increased fall risk and served as a marker of disease progression. Previous studies reported that some factors might influence gait variability. However, which one contributes most has not yet been verified. Therefore, the purpose of the present study is to identify the more related influencing factors on gait variability in people with PD.

Official Title
-----------------
Influencing Factors and Improving Strategy on Gait Variability in People With Parkinson's Disease

Conditions
-----------------
Parkinson Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Idiopathic PD Hoehn and Yahr stages I through III Ability to stand and walk 5 m independently with or without any walking aids Stable medication usage Exclusion Criteria: Unstable medical conditions Any neurological, cardiopulmonary or orthopedic problem/diseases that may interfere with participating the study

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gait variability | Using GAITRite system to measure coefficient of variation | 10 minutes | 
| Walking speed | Using GAITRite system to evaluate | 10 minutes | 
| Sensory organization test | Using NeuroCom Smart Balance Master to measure | 20 minutes | 
| Part III of the Unified Parkinson's Disease Rating Scale | The score ranged from 0 to 72. Higher scores show increased severity. | 20 minutes | 
| Tinetti Balance Scale | The score ranged from 0 to 28. Higher scores show better balance. | 10 minutes | 
| New freezing of gait questionnaire | The score ranged from 0 to 29. Higher scores show increased severity in freezing of gait. | 15 minutes | 
| Montreal Cognitive Assessment | The score ranged from 0 to 30. Higher scores show better cognitive function. | 20 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Parkinson's disease, Gait variability
Storage of Bile From Routine Procedures to Study Risk Factors

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to establish a repository of human bile as a resource for studies evaluating molecular predictors of biliary cancer risk.

Detailed Description
-----------------
The specific aim of this study is to establish a repository of human bile to serve as a resource for studies looking at molecular predictors of biliary tract cancer. The development of fluid based biomarkers will enable early diagnosis in at-risk individuals with a recognized risk factor for cholangiocarcinoma, as well as provide surveillance mechanisms for screening populations where biliary tract cancer has a high incidence.

Official Title
-----------------
A Prospective Study of Human Bile and Molecular Predictors of Biliary Malignancy Risk

Conditions
-----------------
Gallbladder Cancer, Cholangiocarcinoma, Biliary Tract Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Presenting to IU for treatment of biliary tract disease; Age greater than or equal to 18 Exclusion Criteria: Problems other than biliary tract disease

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Establish Repository of Human Bile | Establish a repository of human bile that will serve as a resource through which studies can be performed looking at molecular predictors of biliary tract cancer risk. | 2024 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Storage, Bile, Biomarkers, biliary malignancies
Characterizing the cerebrovAscular Physiology of Optimal Mean Arterial Pressure Targeted Resuscitation

Study Overview
=================
Brief Summary
-----------------
Hypoxic ischemic brain injury is a devastating illness that occurs after cardiac arrest (the heart stopping) and can yield irreversible brain damage, often leading to death. The mainstay in therapy is to optimize the delivery of oxygen to the brain to help it recover. In patients with traumatic brain injury (similar to HIBI), the investigators are able to optimize oxygen delivery to the brain with the use of wires placed into the brain that sense the pressure and oxygen in the skull to find the ideal blood pressure for each individual patient. This strategy is associated with improved outcomes. The investigators are conducting a prospective study investigating whether the perfusion within proximity to the optimal MAP is associated with improved brain oxygenation and blood flow .

Official Title
-----------------
Characterizing the cerebrovAscular Physiology of Optimal Mean Arterial Pressure Targeted Resuscitation in Hypoxic Ischemic Brain Injury After Cardiac Arrest

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

Intervention / Treatment
-----------------
* Device: Multimodal Neuromonitoring


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed cardiac arrest with return of spontaneous circulation > 10 minutes post resuscitation GCS < 9 Exclusion Criteria: concurrent coagulopathy prior history of TBI, intracranial hemorrhage, subarachnoid hemorrhage anticipated cardiac catheterization within next 7 days anticipated or current use of anticoagulants or anit-platelets

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: Basic Science
Intervention Model: Single Group Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Internal arm<br> | Device: Multimodal Neuromonitoring<br>* Application of multimodal neuromonitoring<br>* Other names: Targeted optimal MAP resuscitation;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cerberal blood flow | mls/100g/min | 12 hours |
A Randomized Controlled Trial of Exercise Training Among Men With Type 2-diabetes

Study Overview
=================
Brief Summary
-----------------
To test the hypothesis that there is no difference in change in HbA1C among men with type 2-diabetes after an exercise intervention with strength versus endurance training.

Detailed Description
-----------------
Exercise training is well documented as part of effective treatment for type 2-diabetes patients. Endurance training has been suggested as the most suitable form of exercise. There are reasons to believe that strength training also has a positive effect. However, comparisons of endurance training and strength training regimes are limited. Therefore we randomized 26 men with type 2-diabetes to either an endurance training group or a strength training group. Both groups exercised three sessions per week for three months. The training was supervised.

Official Title
-----------------
A Randomized Controlled Trial of Strength Versus Aerobic Exercise Training to Improve Glycemic Control in Men With Type 2-diabetes

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

Intervention / Treatment
-----------------
* Behavioral: Endurance training
* Behavioral: strength training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with type 2-diabetes Male, 35-71 years Managing their diabetes through a lifestyle and/or the drug metformin only Able to participate in either of the exercise groups Exclusion Criteria: Symptomatic cardiovascular disease Uncontrolled hypertension Physical or cognitive disabilities that will interfere with participating in the exercise regimes. Trained consistently during the last six months.

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 71 Years

Sexes Eligible for Study
-----------------
Male

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 |
| --- | --- |
| Active Comparator: endurance training<br>supervised endurance training | Behavioral: Endurance training<br>* supervised endurance training. Three sessions per week in three months.<br>* Other names: Aerobic training;|
| Experimental: strength training<br>Supervised strength training | Behavioral: strength training<br>* Supervised strength training. Three sessions per week in three months.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1C |  | 12.01.08 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| body composition, C-peptid, BP, Cholesterol (LDL, HDL), Triglycerides |  | 12.01.08 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
RCT, Type 2-diabetes, exercise therapy, Norway
A Study to Evaluate the Efficacy and Safety of Seletracetam in Adult Patients With Refractory Partial Onset Seizures

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the effectiveness and safety of seletracetam when it is used in addition to other anti-epileptic medications by patients with partial onset seizures. It will also help to determine the best dose to use.

Official Title
-----------------
A Phase IIb/III, Double-blind, Parallel-group, Placebo-controlled, Randomized Study: Evaluation of the Efficacy and Safety of Seletracetam as Adjunctive Treatment in Subjects (≥16 to 70 Years Old) With Refractory Partial Onset Seizures.

Conditions
-----------------
Epilepsies, Partial

Intervention / Treatment
-----------------
* Drug: Seletracetam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects from 16 to 70 years old Confirmed diagnosis of focal epilepsy Partial seizures uncontrolled while taking 1 or 2 AEDs At least 8 partial seizures during the 8-week baseline period Exclusion Criteria: Seizures occurring only in clusters Status epilepticus within 1 year Progressive CNS disorder Other serious or uncontrolled diseases

Ages Eligible for Study
-----------------
Minimum Age: 16 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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the efficacy of seletracetam compared to placebo in reducing seizure frequency in subjects with partial onset seizures not fully controlled despite treatment with 1 - 2 concomittant AEDs |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Explore the dose/clinical response relation; safety and tolerability; effects of treatment on patients' Health-Related Quality of Life (HRQoL) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Partial, Seletracetam, Epilepsies, Epilepsy, Focal
Prevalence of Psychiatric Disorders in the Refugee Population of Turkey

Study Overview
=================
Brief Summary
-----------------
The investigators are planning to diagnose psychiatric disorders in willing participants from the refugee population in Turkey.

Official Title
-----------------
Prevalence of Psychiatric Disorders in the Refugee Population of Turkey

Conditions
-----------------
Psychiatric Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Having official refugee status in Turkey, willing to participate in the study Exclusion Criteria: Having any disability that prevents answering interviewers' questions

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Any diagnosed psychiatric disorder using the Mini-International Neuropsychiatric Interview | The Mini-International Neuropsychiatric Interview (M.I.N.I.) is a short structured diagnostic interview designed to screen for DSM-5 and ICD-10 psychiatric disorders. It will be utilized on willing participants from Turkey's refugee population. | Through study completion, on average five months |