linjc16/ctgov huggingface dataset:
A Multiple-dose Study of Gantenerumab in Japanese Alzheimer&Apos;s Disease Patients

Study Overview
=================
Brief Summary
-----------------
Objective of this study is to evaluate the safety, tolerability, pharmacokinetics and preliminary pharmacodynamic effects of multiple doses of Gantenerumab in subject with mild to moderate AD.

Official Title
-----------------
A Multi-center, Multiple-ascending Dose, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Investigate the Safety, Tolerability and Pharmacokinetics of Gantenerumab Following Subcutaneous Injection in Japanese AD Patients

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

Intervention / Treatment
-----------------
* Drug: Gantenerumab
* Drug: Gantenerumab
* Drug: Gantenerumab
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have a diagnosis of probable AD dementia, based on NINCDS/ADRDA criteria Meet DSM-IV criteria for Dementia of the Alzheimer type MMSE score : 16 to 26 etc. Exclusion Criteria: Meet the exclusion criteria of MRI at screening. A history of significant neurodegenerative diseases or dementia other than Alzheimer's disease. etc.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 80 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: 1<br> | Drug: Gantenerumab<br>* 75 mg subcutaneous doses every 4 weeks for 24 weeks<br>|
| Experimental: 2<br> | Drug: Gantenerumab<br>* 105 mg subcutaneous doses every 4 weeks for 24 weeks<br>|
| Experimental: 3<br> | Drug: Gantenerumab<br>* 225 mg subcutaneous doses every 4 weeks for 24 weeks<br>|
| Experimental: 4<br> | Drug: Placebo<br>* subcutaneous doses every 4 weeks for 24 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with Adverse Events |  | 36 weeks | 
| Pharmacokinetic parameters of Gantenerumab in plasma |  | 36 weeks | 
| CSF/plasma ratios of Gantenerumab. |  | Baseline, Day183 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in plasma Abeta |  | Baseline,Day183 | 
| Change from baseline in plasma and CSF tau |  | Baseline,Day183 | 
| Change from baseline in Mini-Mental State Examination (MMSE) and Alzheimer's disease assessment scale cognitive behaviors (ADAS-Cog). |  | Baseline,Day85, 197, 253 |
Hyoscine Butyl Bromide in Reducing Pain During HSG

Study Overview
=================
Brief Summary
-----------------
Many oral analgesic drugs such as nonsteroidal anti-inflammatory drug(NSAID) are used to relieve pain from gynecological procedure and dysmenorrhea. Hyoscine-N-butyl bromide, an antispasmodic drug are commonly used for relief of smooth muscle spasms and can use to relieve genito-urinary spasm. Some studies reported hyoscine can't relieve pain in minor gynecological procedures. So the efficacy of hyoscine use are still controversial and no previous studies investigated its efficacy for pain relief in HSG procedure.

Official Title
-----------------
Randomized Clinical Trial of Oral Hyoscine Butyl Bromide in Reducing Pain During HSG

Conditions
-----------------
Pain Relief With HSG

Intervention / Treatment
-----------------
* Drug: hyoscine butyl bromide
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The infertile women who indicated for HSG. Exclusion Criteria: contraindications to Hyoscine or NSAID - known sensitivity to these drugs known sensitivity to contrast media abnormal uterine bleeding genital tract infection suspected pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 42 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br>oral hyoscine butyl bromide; 2 tablets (buscopan 10 mg) 30 minutes before the procedure | Drug: hyoscine butyl bromide<br>* oral hyoscine butyl bromide; 2 tablets (buscopan 10 mg) 30 minutes before the procedure<br>* Other names: BUSCOPAN;|
| Placebo Comparator: Group B<br>oral 2 tablets (PLACEBO) 30 minutes before the procedure | Drug: placebo<br>* oral placebo; 2 tablets 30 minutes before the procedure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean pain score during. hysterosalpingography by visual analog scale |  | intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean pain score after hysterosalpingography |  | 30 minutes |
Ph1 Lobeline Interaction Study - 1

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if there are significant cardiovascular or other interactions between sublingual lobeline and intravenous methamphetamine.

Official Title
-----------------
Double-Blind, Placebo-Controlled, Cross-Over Assessment of Intravenous Methamphetamine and Sublingual Lobeline Interactions

Conditions
-----------------
Methamphetamine Dependence

Intervention / Treatment
-----------------
* Drug: Lobeline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be between the ages of 18 and 45 years of age Be in general good health with a history of methamphetamine (MA) abuse (but not dependence) If female and of child bearing potential, agrees to use birth control Be able to understand and provide written informed consent Have a body mass index between 18 and 30 Have reported use of (MA) during the past three months without experiencing adverse consequence plus a life time MA or amphetamine use history of at least four occasions of use Have a negative drug test (barbiturates, benzodiazepines, amphetamines, opiates, cocaine, cannabinoids, ethanol) at screening and at the time of admission Exclusion Criteria: Please contact site for details

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

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

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: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular responses |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective effects |  |  |
Caphosol for the Reduction of Mucositis in Patients Receiving Radiation Therapy for Head and Neck Cancer

Study Overview
=================
Brief Summary
-----------------
Patients who have been diagnosed with a head and/or neck cancer commonly develop oral mucositis (OM). The purpose of this study is to estimate the effect of Caphosol on OM and to evaluate if Caphosol had any effect on clinical outcomes which include quality of life, oral intake, swallowing function and pain.

Official Title
-----------------
Caphosol for the Reduction of Mucositis in Patients Receiving Radiation Therapy for Head and Neck Cancer

Conditions
-----------------
Oral Mucositis

Intervention / Treatment
-----------------
* Device: Caphosol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed Head and Neck Cancer patients with planned Radiation therapy Have at least one of 10 pre-defined anatomic mucosal subsites on view Age >/= 18 years Life expectancy >/= 6 months Planned RT to the head/neck Must be able to perform oral rinse Exclusion Criteria: Active infections of oral cavity physiologic condition that precludes the use of an oral rinse Hypersensitivity to Caphosol ingredients Presence of mucosal ulceration at baseline Poorly controlled hypertension, DM or other serious medical/psychiatric illness

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: Health Services Research
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Caphosol|Oral Mouth Rinse|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective is to estimate ht incidence of OM in H&N cancer patients undergoing radiation therapy with or without chemotherapy and/or sensitizer who receive Caphosol. |  | 15 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary objective of this study is to correlate components of OM data with clinical outcomes (pain, narcotic use, oral intake) |  | 15 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Caphosol, Oral Mucositis, Eusa Pharma, Moffitt Cancer Center
A Nutrition-Focused Quality Improvement Program in Hospitalized Malnourished Patients

Study Overview
=================
Brief Summary
-----------------
This study includes pre and post-Quality Improvement Program groups. A nutrition-focused Quality Improvement Program will be implemented to assess the health and economic outcomes in malnourished hospitalized patients.

Official Title
-----------------
Assessing the Impact of A Nutrition-Focused Quality Improvement Program in Hospitalized Malnourished Patients in an Academic University Hospital in Vietnam

Conditions
-----------------
Malnutrition

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is at risk / malnourished, defined by an MST score ≥ 2 the first 24 hours post hospital admission Patients are admitted for the following diagnoses: Respiratory, Digestive Surgery, Cardiology, General Internal Medicine (including Endocrinology), and Gastrointestinal Patient is able to consume foods and beverages orally Patients with life expectancy ≥ 30 days Patient is literate and willing to voluntarily sign and date Informed Consent Form (ICF) Exclusion Criteria: Subject has severe dementia or delirium and has no dedicated caregiver who could assure their compliance with QIP study requirements Subject has an eating disorder, history of significant neurological or psychiatric disorder, or other conditions that may interfere with study product consumption or compliance with study protocol procedures Subject is known to be allergic or intolerant to any ingredient found in the study products Subject is pregnant Subject is intubated, receiving tube feeding or parenteral nutrition

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Historical Group 1<br>Patients admitted at UMC between September 2015 and October 2016 | |
| Historical Group 2<br>Patients admitted at UMC between November 2016 and up to the beginning of the QIP | |
| Nutrition-Focused QIP<br>Patients admitted at UMC that meet eligibility criteria and prospectively enrolled into QIP including malnutrition screening, nutrition consultation, expedited provision of oral nutritional supplementation (ONS) and encouragement of ONS consumption 30-days post discharge | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Length of Stay | Chart Review | From Date of Admission until Date of Discharge or Death from any cause, assessed through follow up (30-day Post Discharge) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healthcare Resource Utilization | Chart Review | Hospital Admission to 30-day Post Discharge |
Macrophagic Activation and Immunophenotypic Profile of Patients With Gaucher's Disease

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate macrophaging activity and immunologic profile of patients with Gaucher 's disease. For this, one blood sampling will be performed.

Official Title
-----------------
Evaluation of Macrophagic Activation and Immunophenotypic Profile of Patients With Gaucher's Disease.

Conditions
-----------------
Patients With Gaucher's Disease

Intervention / Treatment
-----------------
* Other: Blood sampling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults (age equal or above 18. Patients with Gaucher 's disease treated in the Grand Ouest competence center patients affiliated to social security Informed consent signed Exclusion Criteria: - Children (age<18)

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Blood sampling|One blood sampling is required for the research|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the implication of acquired and inherent immunity in the Gaucher's clinical phenotype at moment of blood sampling |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to find new activity mark for Gaucher's disease by studying macrophagic activation's markers. |  |  |
The Relationship Between Brain Volume and Sensory Integration in Autistic and Attention Deficit Hyperactivity Disorder.

Study Overview
=================
Brief Summary
-----------------
The relationship between brain volume and sensory integration in children and adolescence with attention deficit hyperactivity disorder and autistic spectrum disorder; comparative study

Detailed Description
-----------------
Detect pattern of sensory disintegration in autistic and attention deficit hyperactivity disorder children and adolescence. Also detect relationship between changes in brain and sensory disintegration in each group.

Official Title
-----------------
The Relationship Between Brain Volume and Sensory Integration in Children and Adolescence With Attention Deficit Hyperactivity Disorder and Autistic Spectrum Disorder.

Conditions
-----------------
Sensory Integration Dysfunction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria .Diagnosis of Autism spectrum disorders /ADHD verified and confirmed on a clinical basis. . Willing of the parents or the caregivers to participate in the study. Exclusion Criteria: .Children with intelligence quotient below 70. .Children with history or current substance use. .Children with medical or other neurological conditions. .Children with history of preterm labour (as brain volume lower than term delivery). -

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum 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 |
| --- | --- |
| Autistic children<br>magnetic resonance imaging brain for autistic children | |
| attention deficit hyperactivity disorder children<br>magnetic resonance imaging brain for attention deficit hyperactivity disorder children | |
| Normal children<br>magnetic resonance imaging brain for Normal children | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sensory disintegration in neurodevelopmental disorders | Estimate the prevalence of sensory disintegration problems among study groups and differentiate the pattern of sensory disintegration problems among study groups. | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sensory disintegration
Study of Bone Marrow Samples From Patients With Acute Leukemia

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Studying the genes expressed in samples of bone marrow from patients with cancer may help doctors identify biomarkers related to cancer. PURPOSE: This research study is looking at bone marrow samples from patients with acute leukemia.

Detailed Description
-----------------
OBJECTIVES: To perform high throughput sequencing of a set of megakaryocyte specific transcription factors, tyrosine kinases, and Src kinases in DNA isolated from bone marrow specimens of adults with acute megakaryoblastic leukemia (AMKL). To assay the ability of Src kinase inhibitors (SU6656, dasatinib) to induce differentiation of AMKL blasts in these patients. OUTLINE: DNA from previously collected bone marrow samples are sequenced to analyze genes associated with transcription factors (GATA1, GATA2, SCL, FOG-1, ETS1, ETS2, ERG, FLI-1, GABP, HOXA11, NF-E2, and RUNX1), tyrosine kinases (JAK2, JAK3, and c-MPL), and Src family kinases (LYN, FYN, and HCK) and compared with control DNA. Using bioinformatics, gene alterations are compared to known polymorphisms and subsequent changes in the amino acid sequence of the encoded protein. Subsequent assays assess the effect on proliferation and differentiation and in vitro studies evaluate the consequences of mutations on transcription factor and kinase activity abilities. The effect of SU6656 and dasatinib on cell death and polyploidization is evaluated by flow cytometry and compared with control DNA.

Official Title
-----------------
Identifying the Genetic Basis of Adult AMKL

Conditions
-----------------
Leukemia

Intervention / Treatment
-----------------
* Genetic: gene expression analysis
* Genetic: mutation analysis
* Genetic: polymorphism analysis
* Genetic: protein analysis
* Other: flow cytometry
* Other: laboratory biomarker analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Diagnosis of adult acute megakaryoblastic leukemia Archived bone marrow specimens from the ECOG tissue repository PATIENT CHARACTERISTICS: Not specified PRIOR CONCURRENT THERAPY: Not specified

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 120 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: gene expression analysis|nan|
|Genetic: mutation analysis|nan|
|Genetic: polymorphism analysis|nan|
|Genetic: protein analysis|nan|
|Other: flow cytometry|nan|
|Other: laboratory biomarker analysis|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of gene mutations with adult acute megakaryoblastic leukemia (AMKL) |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
adult acute megakaryoblastic leukemia (M7)
Epidemiology of Hepatitis B, C and Delta in Reunion Island

Study Overview
=================
Brief Summary
-----------------
Viral hepatitis B, C and Δ represent a global public health problem for which France was very early mobilized. Despite this, in its foreword, the Dhumeaux report on Management of people infected with hepatitis B or hepatitis C viruses identifies a residual area of weakness in this care that is the incomplete regional epidemiological data in the Overseas Territories. The specific ethno-socio-cultural characteristics of these territories make it difficult to transpose data from the mainland France. This study aims at improving our knowledge on the characteristics of patients with hepatitis B, C and Δ in Reunion Island, their follow-up, their evolution and complications.

Official Title
-----------------
Epidemiology of Hepatitis B, C and Delta in Reunion Island

Conditions
-----------------
Hepatitis B, Hepatitis C, Hepatitis D

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Major patient with confirmed HBsAg and / or anti HCV positive Ab residing in Reunion Island followed in one of the participating centers Exclusion Criteria: • Patient carrying isolated anti HBc antibodies

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 |
| --- | --- | --- |
| Number of patients with hepatitis B, C and Δ in Reunion | Hepatitis diagnosis will be made according to the ongoing guidelines in France (referred by the National AIDS and Hepatitis Research Agency (ANRS) | Up to 5 years |