linjc16/ctgov huggingface dataset:
Study Evaluating The Potential Interaction Between Verapamil Immediate Release And SAM-531 When Co-Administered

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effects of multiple doses of verapamil on the plasma concentration of a single dose of SAM-531 in healthy young adult subjects and to assess the safety and tolerability of co-administration of SAM-531 and verapamil.

Official Title
-----------------
An Open-label, Nonrandomized Study to Evaluate the Potential Pharmacokinetic Interaction Between Multiple Doses of Verapamil Immediate Release (IR) and a Single Dose of SAM-531 When Co-administered Orally to Healthy Young Adult Subjects

Conditions
-----------------
Alzheimer Disease

Intervention / Treatment
-----------------
* Drug: SAM-531


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria : Body mass index in the range of 18 to 30 kg/m2 and body weight greater than 50 kg. Healthy as determined by the investigator on the basis of medical history, physical examination findings, clinical laboratory test results, vital sign measurements, and digital 12-lead ECG readings. Exclusion criteria : Presence or history of any disorder that may prevent the successful completion of the study. Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal (GI), endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: SAM-531<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood samples |  | 7 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety based on supine vital signs evaluations, 12-lead ECGs and routine lab tests |  | 7 weeks |
Study of Protein Translocation in Patients With Beta-Oxidation Disorders

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Characterize inheritance patterns of mutations in patients with beta-oxidation disorders.

Detailed Description
-----------------
PROTOCOL OUTLINE: Patients undergo clinical and molecular analysis of beta-oxidation enzyme metabolism. The evaluation includes a urinary metabolite profile, and DNA and familial studies.

Conditions
-----------------
Beta-Oxidation Disorder, Peroxisomal Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: Beta-oxidation disorder, including: Medium-chain acyl-coenzyme A dehydrogenase deficiency Long-chain 3-hydroxyacyl coenzyme A dehydrogenase deficiency Very-long-chain acyl-coenzyme A dehydrogenase deficiency Short-chain 3-hydroxyacyl coenzyme A dehydrogenase deficiency Long-chain 3-ketoacyl-coenzyme A thiolase deficiency Trifunctional protein deficiency Patient age: 1 day and over

Ages Eligible for Study
-----------------
Minimum Age: 1 Day

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
beta-oxidation disorder, inborn errors of metabolism, rare disease
Intercontinental Cooperative Non-Hodgkin T-cell Lymphoma Prospective Registry Study

Study Overview
=================
Brief Summary
-----------------
The better understanding of non-Hodgkin T-cell lymphoma is essential for establishing effective treatment strategy for non-Hodgkin T-cell lymphoma. Therefore, the data about conical features and treatment outcomes of each subtype should be accumulated to establish treatment strategy. However, the majority of previous data for non-Hodgkin T-cell lymphoma was from small case series of single institute. Furthermore, as novel drugs were developed for the treatment of relapsed or refractory T-cell lymphoma, the date from patients who were treated with those novel drugs are especially required because their outcomes may reflect the outcomes of currently available treatments. Thus, a multinational, multicenter prospective registry study is needed to provide information useful for establishing treatment strategies for T-cell lymphoma.

Official Title
-----------------
Intercontinental Cooperative Non-Hodgkin T-cell Lymphoma Prospective Registry Study

Conditions
-----------------
Non-Hodgkin T-cell Lymphoma

Intervention / Treatment
-----------------
* Other: Prospective Registry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pathologically diagnosed Mature T-cell non-Hodgkin lymphoma based on the World Health Organization classification 2008 Newly diagnosed patients without a previous treatment history for T-cell lymphoma or relapsed/refractory T-cell lymphoma patients Age ≥19 years Written informed consent Exclusion Criteria: Hodgkin lymphoma non-Hodgkin B-cell lymphoma Immature non-Hodgkin T-cell lymphoma: Precursor T-lymphoblastic lymphoma/leukemia Not understanding informed consent

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- |
| non-Hodgkin T-cell Lymphoma<br> | Other: Prospective Registry<br>* Survival and disease status follow-up at 1st primary treatment, 1st salvage treatment and 2nd salvage treatment Regimen Response Evaluation SUSAR(Suspected, Unexpected, Serious, Adverse Reaction) collection<br>|

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

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate to primary treatment and salvage treatment |  | 5 years | 
| Progression-free survival |  | 5 years |
Head and Neck Cancer Screening and Serum Repository

Study Overview
=================
Brief Summary
-----------------
Head and Neck Squaumous Cell Cancer(HNSCC) is the 6th most common cancer in the United States and the 3rd most common worldwide. Risk factors include abuse to tobacco and alcohol. Survival is related to stage of HNSCC when treatment is sought. Most HNSCC patients present with advanced staged disease. This screening activity will educate patients with HNSCC rick factors and screen for pre malignant and/or early staged lesions.

Detailed Description
-----------------
Otolaryngology staff memebers and residents will perform head and neck examinations upon participants after the participant has completed their questionnaire and had the opportunity to partcipate in the research portion by having blood drawn. A suspicious head and neck examination will be considered abnormal, and further recommendations for follow-up will be made. Participants will be provided with a list of practicing head and neck surgeons within the state of Arkansas.

Official Title
-----------------
Head and Neck Cancer Screening and Serum Repository

Conditions
-----------------
Head and Neck Squamous Cell Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Exclusion Criteria: Under the age of 18 years of age

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 |
| --- | --- | --- |
Descemet Membrane Endothelial Keratoplasty (DMEK)

Study Overview
=================
Brief Summary
-----------------
To evaluate isolated Descemet membrane transplantation as a refinement of previous advanced techniques for corneal transplantation, like Descemet Stripping Endothelial Keratoplasty (DSEK)

Detailed Description
-----------------
See above.

Official Title
-----------------
Prospective Clinical Study on Descemet Membrane Endothelial Keratoplasty (DMEK)

Conditions
-----------------
Corneal Dystrophies, Hereditary

Intervention / Treatment
-----------------
* Procedure: Descemet Membrane Endothelial Keratoplasty (DMEK)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Corneal endothelial disorders Exclusion Criteria: N/A

Ages Eligible for Study
-----------------
Minimum Age: 21 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: DMEK<br>DMEK as intervention | Procedure: Descemet Membrane Endothelial Keratoplasty (DMEK)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best spectacle corrected visual acuity |  | 2005-2015 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal endothelial cell density |  | 2005-2015 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Corneal transplantation, Descemet membrane
Mediastinal Grey Zone Lymphoma From the LYSA

Study Overview
=================
Brief Summary
-----------------
Mediastinal grey zone lymphoma, B cell lymphomas with intermediate features between classical Hodgkin lymphoma and primary mediastinal B cell lymphoma, are not well described in the literature. Investigators report the clinical characteristics and outcomes of a large retrospective series of 99 cases centrally reviewed by a panel of hematopathologists, with a consensus established for the diagnosis.

Official Title
-----------------
Mediastinal Grey Zone Lymphoma: Clinico-pathological Characteristics and Outcomes of 99 Patients From the LYSA

Conditions
-----------------
Mediastinal Grey Zone Lymphoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cases with an intermediate morphology and phenotype between CHL and PMBCL were included after central pathological review Exclusion Criteria: Cases of CHL with partial CD20 expression or low expression in tumoral cells were excluded and considered as CD20-positive CHL Exclusion of sequential form patients (with a diagnostic biopsy of PMBCL and a relapse biopsy of CHL or vise-versa) as they represent a biases for statistical analysis.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CHL like GZL<br>Classical Hodgkin Lymphoma like Grey Zone Lymphoma (morphology of CHL and phenotype of PMBCL) | |
| PMBCL like GZL<br>Primary Mediastinal B Cell Lymphoma like Grey Zone Lymphoma(morphology of PMBCL and phenotype of CHL) | |
| Composite<br>with a morphology of CHL on the one side and of PMBCL on the other side of the same diagnosis biopsy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EFS in the global population of GZL | Event-free survival (EFS) was calculated from the date of diagnosis to the date of progression, a change of therapy that was not initially scheduled (radiotherapy, high-dose therapy with autologous stem cell transplantation and other unplanned treatments) or death from any cause. | EFS: Event Free Survival from date of randomization until the date of first documented progression, up to 130 months |
Kid STRIDE: Exploring Participation in a Family-based Intervention

Study Overview
=================
Brief Summary
-----------------
The aim of this qualitative study is to explore parental and child perceptions of participating in a family-based behavioral intervention targeting healthy behaviors.

Detailed Description
-----------------
Children ages 9-14 have been participating in the Kid STRIDE study which is a family-based behavioral intervention for obese children. Participants will be divided into 3 groups according to their change in weight: 1) children who lost greater than 5% of body weight; 2) children who lost less than 5% of body weight or gained less than 1% of body weight; 3) children who gained greater than 1% of body weight. We will invite five families from each of groups 1 and 3 to participate in an open-ended interview.

Official Title
-----------------
Kid STRIDE: Exploring Participation in a Family-based Intervention

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Completed the 15-week primary intervention phase of Kid STRIDE

Ages Eligible for Study
-----------------
Minimum Age: 9 Years
Maximum Age: 16 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 |
| --- | --- |
| Parent & Child Dyad<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Explore parental and child perceptions of participating in a family-based behavioral intervention targeting weight reduction. |  | After completion of primary group intervention. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pediatrics, overweight, obese, behavioral intervention
The Effect of Saccharomyces Boulardii in Clinical Presentation and Quality of Life Patient With IBS

Study Overview
=================
Brief Summary
-----------------
This study aims to compare the effectiveness of Saccharomyces Boulardii vs Placebo in patient with Irritable Bowel Syndrome

Detailed Description
-----------------
This study aims to compare the effectiveness of Saccharomyces Boulardii vs Placebo in patient with Irritable Bowel Syndrome within timeframe of study 28 days and then will be examined the outcome as the improvement quality of life

Official Title
-----------------
The Effect of Saccharomyces Boulardii in Clinical Presentation and Quality of Life Patient With IBS

Conditions
-----------------
Irritable Bowel Syndrome

Intervention / Treatment
-----------------
* Drug: Saccharomyces Boulardii 250 MG
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criterias: 18 years or older diagnosed with IBS based on ROME IV criteria agree to be participant by signing inform consent Exclusion Criteria: patient who does not want to sign the inform 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?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>Get intervention drug Normagut capsule twice a day | Drug: Saccharomyces Boulardii 250 MG<br>* Normagut capsule twice a day<br>* Other names: Normagut;|
| Placebo Comparator: Control Group<br>Get placebo capsule twice a day | Drug: Placebo<br>* Placebo capsule twice a day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical improvement quality of life within 29 days | Measuring quality of life using questionnaire IBS-QOL from 0-100, the higher the score, the better the outcome. | 29 days |
Phase I/II Study of Recombinant Human Hepatocyte Growth Factor in Fulminant Hepatic Failure

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether recombinant human hepatocyte growth factor is safe and effective in the treatment of fulminant and late-onset hepatic failure.

Detailed Description
-----------------
Fulminant and late-onset hepatic failure (LOHF) is intractable disease with high degree of fatality (70-80%). Only liver transplantation is established as a therapeutic modality to rescue patients with fulminant hepatic failure or LOHF. However, approximately 75% of the patients are not able to receive liver transplantation in Japan, and effective non-surgical treatment has not been established yet. Hepatocyte growth factor (HGF) is one of major agents stimulating liver regeneration and ameliorating hepatic injury. In this study, recombinant human HGF is administered to patients with fulminant hepatic failure or LOHF, who can not receive liver transplantation.

Official Title
-----------------
Phase I/II Study of Recombinant Human Hepatocyte Growth Factor in Fulminant and Late-Onset Hepatic Failure

Conditions
-----------------
Liver Failure, Acute

Intervention / Treatment
-----------------
* Drug: Recombinant human hepatocyte growth factor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of fulminant or late-onset hepatic failure Must be unable to receive liver transplantation Exclusion Criteria: Under 16 years old Cancer patients Pregnancy-aged women Impaired renal function Impaired cardiac function Severe complications including pneumonia, sepsis, DIC and so on

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

| Intervention/Treatment |
| --- |
|Drug: Recombinant human hepatocyte growth factor|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All adverse effects throughout the protocol |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival time at 4 weeks |  |  | 
| Degree of hepatic encephalopathy at 3, 5, 8, 11, 15, 21, and 28 days |  |  | 
| Liver function test at at 3, 5, 8, 11, 15, 21, and 28 days |  |  |
Weekly Carboplatin/Docetaxel for Recurrent Ovarian/Peritoneal Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety and efficacy of this regimen in women with ovarian or peritoneal cancer

Official Title
-----------------
Phase II Evaluation of Weekly Docetaxel in Combination With Weekly Carboplatin in the Treatment of Recurrent Epithelial Ovarian Carcinoma

Conditions
-----------------
Ovarian Carcinoma, Primary Peritoneal Carcinoma

Intervention / Treatment
-----------------
* Drug: Carboplatin
* Drug: Docetaxel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Recurrent ovarian or peritoneal cancer Exclusion Criteria: No prior chemotherapy

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

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

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

| Intervention/Treatment |
| --- |
|Drug: Carboplatin|nan|
|Drug: Docetaxel|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Efficacy |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QOL |  |  |
Evaluation of Pancreatic Tissue Penetration of Meronem® in the Prophylaxis of Septic Complications in Severe Pancreatitis

Study Overview
=================
Brief Summary
-----------------
To measure meropenem pancreatic tissue penetration in subjects with severe pancreatitis requiring surgery between 30 to 60 minutes after a bolus of 1 g IV meropenem given during the induction period of anesthesia.

Official Title
-----------------
Evaluation of Pancreatic Tissue Penetration of Meronem® in the Prophylaxis of Septic Complications in Severe Pancreatitis

Conditions
-----------------
Pancreatitis

Intervention / Treatment
-----------------
* Drug: Meropenem


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with diagnosis of severe pancreatitis requiring surgery according to the protocol of each Institution. Informed consent signed by the subject Subjects who have received prophylactic antibiotics for previous invasive procedures different from surgery may be included Exclusion Criteria: Will of the subject not to be included Subjects who have not signed the informed consent Subjects with known hypersensibility to carbapenems, penicillins, or cephalosporins
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To measure meropenem pancreatic tissue penetration in subjects with severe pancreatitis requiring surgery between 30 and 60 minutes after a bolus of 1 g IV meropenem applied during induction of anesthesia. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To describe the incidence of infectious complications during the first 30 days after surgery in subjects with severe pancreatitis receiving IV meropenem at a dose of 1 g every 8 hours during 14 days. |  |  |