linjc16/ctgov huggingface dataset:
An Observational Study of Treatment, Outcomes, and Prognosis in Patients With Follicular Non-Hodgkin's Lymphoma

Study Overview
=================
Brief Summary
-----------------
This is a prospective, observational, longitudinal, multicenter study of patients with newly diagnosed follicular Non Hodgkin's Lymphoma (NHL) designed to delineate differences in clinical outcome by comparing the effectiveness and safety of common treatment regimens.

Official Title
-----------------
The National Lymphocare Study: An Observational Study of Treatment, Outcomes, and Prognosis in Patients With Follicular Non-Hodgkin's Lymphoma

Conditions
-----------------
Lymphoma, Non Hodgkin

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed Informed Consent Form (unless the Institutional Review Board [IRB] has granted a waiver of consent) Signed Authorization for the Use and Disclosure of Health Information document Age ≥18 years Histologic documentation of follicular NHL, according to Revised European-American Lymphoma (REAL) classification system, as assessed by the local pathologist and treating physician Initial diagnosis of follicular B-cell NHL within 6 months prior to enrollment Availability of cancer-specific historical data points in the patient's medical records Exclusion Criteria: Other indolent or histologic NHL subtypes Diagnosis of lymphoma > 6 months prior to enrollment

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Follicular Non-Hodgkin's Lymphoma
Performance Evaluation of OCT and OCT Angiography-based Ocular Measurements (Optical Coherence Tomography)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess performance of measurements of anatomical and vascular structures of the eye based on OCT and OCTA scans in normal subjects and eyes with pathology.

Official Title
-----------------
Performance Evaluation of OCT and OCTA-based Ocular Measurements

Conditions
-----------------
Normal Eyes and Ocular Pathology

Intervention / Treatment
-----------------
* Device: optical coherence tomography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Normal - No pre-existing conditions. Glaucoma - Diagnosis of glaucoma. Retina - Diagnosis of retinal pathology Cornea - Diagnosis of clinic condition. Exclusion Criteria: - Unable to complete required exams.

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 |
| --- | --- |
| Normal<br>no pre-existing conditions | Device: optical coherence tomography<br>* imaging structural and vascular features of the eye<br>|
| Glaucoma<br>diagnosis of glaucoma | Device: optical coherence tomography<br>* imaging structural and vascular features of the eye<br>|
| Retina<br>diagnosis of retina pathology | Device: optical coherence tomography<br>* imaging structural and vascular features of the eye<br>|
| Cornea<br>diagnosis of corneal condition | Device: optical coherence tomography<br>* imaging structural and vascular features of the eye<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Standard Deviation | measure of variance | Day 1 |
Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BMS-708163

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the pharmacokinetics, safety and tolerability of BMS-708163 administered as single and multiple doses in Chinese subjects

Official Title
-----------------
Randomized, Placebo-controlled, Double-blind, Single- and Multiple-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BMS-708163 in Healthy Young Male and Elderly Male and Female Chinese Subjects

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

Intervention / Treatment
-----------------
* Drug: BMS-708163
* Drug: BMS-708163
* Drug: Placebo
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male subjects 18-45 yrs old and 65 yrs or older inclusive and postmenopausal female 65 yrs or older Exclusion Criteria: Women of childbearing potential Gastrointestinal disorders Bleeding disorders Peptic ulcer disease Abnormal ECG Abnormal Clinical laboratory tests Abnormal Thyroid Congestive heart failure Cholecystectomy Asthma Hypertension Inability to tolerate oral medication Inability to be venipunctured and/or tolerate venous access

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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A1 (BMS-708163)<br> | Drug: BMS-708163<br>* Capsule, Oral, 50 mg, once daily, 1 Day<br>|
| Placebo Comparator: A2 (Placebo)<br> | Drug: Placebo<br>* Capsule, Oral, 0 mg, One daily, 1 Day<br>|
| Active Comparator: B1 (BMS-708163)<br> | Drug: BMS-708163<br>* Capsule, Oral, 125 mg, once daily, 14 Days<br>|
| Placebo Comparator: B2 (Placebo)<br> | Drug: Placebo<br>* Capsule, Oral, 0 mg, One daily, 14 Day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety assessments will be based on adverse event reports and the results of vital sign measurements, ECGs, physical exams and clinical laboratory tests. Adverse events will be tabulated and reviewed for potential significance and clinical importance |  | Study Day 1 through study completion + 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Single-dose pharmacokinetic parameters (Cmax, Tmax, AUC(0-T), AUC(INF), T-HALF and multiple-dose pk parameters (Cmax, Tmax, Cmin, AUC(TAU), T-HALF, and accumulation index will be derived from plasma concentration versus time data |  | Study Days 1-8 Period 1 and Days 1, 2, 5, 7, 9, 11, and 13-21 Period 2 |
Laser-Assisted Versus Conventional Intracytoplasmic Sperm Injection

Study Overview
=================
Brief Summary
-----------------
Laser-assisted intracytoplasmic sperm injection (ICSI) has been suggested as a more effective alterative to conventional ICSI when this method of insemination is indicated for patients undergoing in vitro fertilization (IVF). Laser-assisted ICSI differs from conventional ICSI in that a laser is used to drill a small hole through the hard outer coating surrounding an egg before the injection needle containing a single sperm is inserted into the egg. The hole eliminates compression of the egg that normally occurs with conventional ICSI, and thus may reduce the chance of damage. Laser-assisted ICSI is hypothesized to result in increased egg survival, and perhaps improved embryo quality, compared to conventional ICSI.

Official Title
-----------------
Laser-Assisted Versus Conventional Intracytoplasmic Sperm Injection

Conditions
-----------------
Infertility, Infertility, Male

Intervention / Treatment
-----------------
* Procedure: Laser-assisted intracytoplasmic sperm injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of infertility Scheduled for IVF with ICSI Exclusion Criteria: Retrieval of fewer than 6 mature oocytes

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Laser-assisted intracytoplasmic sperm injection|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| oocyte survival rate 1 day after ICSI |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| normal fertilization rate 1 day after ICSI |  |  | 
| embryo cell numbers 2 and 3 days after ICSI |  |  | 
| embryo fragmentation rates 2 and 3 days after ICSI |  |  | 
| embryo compaction rate through day 7 after ICSI |  |  | 
| blastocyst formation rate through day 7 after ICSI |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Oocytes, Oolemma, In Vitro Fertilization, Intracytoplasmic Sperm Injection, Zona Pellucida, Fertilization, Preimplantation Embryo Development
Possible Roles of MDW in Infection Management in Emergency Care

Study Overview
=================
Brief Summary
-----------------
A retrospective study to determine the potential value of MDW among other biomarkers in the diagnosis of infection.

Detailed Description
-----------------
MDW as a novel indicator can be useful in clinical practice in the emergency care. However, until now, no study has been published about MDW's general relationship and coherence with multiple, conventional laboratory tests for infections, such as PCT, C-reactive protein (CRP), WBC, neutrophil count (NC), neutrophil percentage and immature granulocyte count (IGC) together.

Official Title
-----------------
Possible Roles of MDW in Infection Management in Emergency Care

Conditions
-----------------
Infection, Sepsis

Intervention / Treatment
-----------------
* Other: blood sample taking


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult (18+ years), receiving care for suspected infection Exclusion Criteria: refuses to sign the consent form

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

| Intervention/Treatment |
| --- |
|Other: blood sample taking|For study purposes, blood sample was taken during the first medical examination from patients with suspected infection.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MDW cutoff value for infection | Cutoff value for MDW indicating infection | 4 months |
Pulmonary Functions in Relation to Gross Motor Function Level

Study Overview
=================
Brief Summary
-----------------
Aim: To investigate the relation between forced expiratory volume at first second and peak expiratory flow with gross motor function level in the children with cerebral palsy. Methods and Procedures: Thirty children with cerebral palsy from both sexes were included in this study. The children ages ranged from 3 to 11 years old.

Detailed Description
-----------------
Methods and Procedures: Thirty children with cerebral palsy from both sexes were included in this study. The children ages ranged from 3 to 11 years old. Children were evaluated using spirometer to assess forced expiratory volume at first second and peak expiratory flow and gross motor function classification system to assess the functional level.

Official Title
-----------------
Pulmonary Functions in Relation to Gross Motor Function Level in The Children With Cerebral Palsy

Conditions
-----------------
Cerebral Palsy

Intervention / Treatment
-----------------
* Diagnostic Test: Assessment of respiratory function and growth motor function classiffication level


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children with cerebral palsy age was from 3 to 11years old They were able to sit independently and to follow instructions. Children who can blow air independently. Exclusion Criteria: Uncontrolled convulsions Any psychiatric disorders

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 11 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Study group<br>Children were evaluated using spirometer to assess forced expiratory volume at first second and peak expiratory flow and gross motor function classification system to assess the functional level. | Diagnostic Test: Assessment of respiratory function and growth motor function classiffication level<br>* Assessment of respiratory function using spirometer and assessment of growth motor function classiffication level using GMFCs<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FEV1 | Forced expiratory volume at first second | baseline ( enrolment) | 
| PEF | Peak Expiratory Flow Peak expiratory flow | baseline ( enrolment) | 
| GMFCs | Growth motor functional classification level | baseline ( enrolment) |
Metabolomic in Critical Ill Patients

Study Overview
=================
Brief Summary
-----------------
Analysis of blood, urinary, and intrathecal metabolites of critical ill patients will be checked for possible correlations between metabolomics patterns and patients' outcomes.

Conditions
-----------------
Metabolomic

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with severe left or right ventricular dysfunction undergoing cardiac surgery patients undergoing ablation of ventricular tachycardia patients with febrile neutropenia after chemotherapy or allogeneic transplant for haematological diseases patients undergoing thoracoabdominal vascular surgery Exclusion Criteria: pregnant women no written consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| criticall ill patients<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolomic patterns to identify poor outcome |  | hospital stay (approximately two weeks) |
Combined Illness Management and Psychotherapy in Treating Depressed Elders

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to test a program developed to help patients with chronic heart or lung problems take care of themselves and cope with their illness or limitations.

Official Title
-----------------
Combined Illness Management and Psychotherapy in Treating Depressed Elders

Conditions
-----------------
Depression, Heart Failure, Chronic Obstructive Pulmonary Disease

Intervention / Treatment
-----------------
* Behavioral: Combined Psychotherapy and Illness Management
* Behavioral: Illness Management Only


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 55 years or older Diagnosis of Heart Failure or COPD Depressive symptoms indicated by a BDI-II score of 10 or higher Functional impairment Exclusion Criteria: Current psychotherapy Cognitive Impairment Psychiatric diagnosis Active suicidal thoughts Significant vision or hearing impairment Residence in long term care facility

Ages Eligible for Study
-----------------
Minimum Age: 55 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Illness Management Only<br> | Behavioral: Illness Management Only<br>* Participants in this group will have 10 weekly sessions with a study clinician at home and by phone. They will focus only on how they manage their illness. Follow up assessments will occur at 26 and 52 weeks.<br>|
| Experimental: Combined Psychotherapy & Illness Management<br> | Behavioral: Combined Psychotherapy and Illness Management<br>* Participants will have 10 weekly visits with a study clinician at their home and by phone. They will focus on their self care and illness management as well as how to manage their mood/cope emotionally. Follow up assessments will occur at 26 and 52 weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in depressive symptoms | Change from Baseline in depressive symtoms at 10 weeks | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in quality of life/functioning | Change from Baseline in quality of life/functioning at 10 weeks | 10 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Depression, Heart Failure, Chronic Obstructive Pulmonary Disease, Quality of Life, Functional Impairment
Multi-Drug Resistant Bacteria Carriage After Travel

Study Overview
=================
Brief Summary
-----------------
During one month, from 1st to 30th November 2016, all patients admitted in one of the medical Dpt of our Hospital (Internal Medicine Dpt, Endocrinology, ICU) will be screened for multi-drug resistant bacteria carriage (after written consent). They will answer to a questionnaire about previous travel in a foreign country during the previous year, hospitalization or not during this travel.

Detailed Description
-----------------
During one month, from 1st to 30th November 2016, all patients admitted in one of the medical Dpt of our Hospital (Internal Medicine Dpt, Endocrinology, ICU) will be screened for multi-drug resistant bacteria carriage (after written consent), regardless a travel in a foreign country during the past year, or not. They will answer to a questionnaire about previous travel in a foreign country during the previous year, hospitalization or not during this travel. The aim of the study will be to compare the rate of carriage of multi-drug resistant bacteria among previous travelers, or not.

Official Title
-----------------
Multi-Drug Resistant Bacteria Carriage After Travel: Comparison Between Patients Who Have Been Hospitalized in a Foreign Country, or Not During the Previous Year

Conditions
-----------------
Beta Lactam Resistant Bacterial Infection (Disorder)

Intervention / Treatment
-----------------
* Biological: rectal swab for Multi-Drug resistant bacteria


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients admitted in one of the medical Dpt of our Hospital who have travelled in a foreign country during the previous year Exclusion Criteria: patients who were unable to give written consent

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

| Intervention/Treatment |
| --- |
|Biological: rectal swab for Multi-Drug resistant bacteria|A rectal swab will be performed at admission of patients to look for intestinal carriage of Multi-Drug resistant bacteria|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Multi-Drug Resistant bacteria carriage rate | Multi-Drug Resistant bacteria carriage assessed by rectal swab | At admission in our Hospital |
Real-World Evidence and Treatment Patterns: Head and Neck Cancer

Study Overview
=================
Brief Summary
-----------------
This study will be focused on HNC patients who have been diagnosed with HNC between 01-Jan-2013 and 30-Sep-2016.

Official Title
-----------------
Real-World Evidence and Treatment Patterns: Head and Neck Cancer

Conditions
-----------------
Head & Neck Cancer

Intervention / Treatment
-----------------
* Other: Non-Interventional


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HNC or undefined histology (not otherwise specified [NOS]) HNC diagnosis from 01-Jan-2013 to 30-Sep-2016 using Japanese disease code Age 18 years or older at initial diagnosis of HNC regardless of staging Exclusion Criteria: Diagnosis of another malignancy on or before the initial diagnosis of HNC with the exception of non-melanoma skin cancer and metastatic cancer Diagnosis of HNC before 01-Jan 2013 or after 30-Sep-2016

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 |
| --- | --- |
| HNC patients<br>HNC patients who have been diagnosed with HNC between 01-Jan-2013 and 30-Sep-2016. | Other: Non-Interventional<br>* Non-Interventional<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients receiving radiotherapy as anti-cancer treatment |  | Approximately 45 months | 
| Proportion of patients receiving surgery as anti-cancer treatment |  | Approximately 45 months | 
| Proportion of patients receiving chemotherapy as anti-cancer treatment |  | Approximately 45 months | 
| Proportion of patients receiving targeted therapy as anti-cancer treatment |  | Approximately 45 months | 
| Proportion of patients receiving supportive care as anti-cancer treatment |  | Approximately 45 months | 
| Distribution of Treatment History in Head and Neck Cancer (HNC) patients |  | Approximately 45 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distribution of overall survival (OS) by age |  | Approximately 45 months | 
| Distribution of overall survival (OS) by gender |  | Approximately 45 months | 
| Distribution of overall survival (OS) by stage |  | Approximately 45 months | 
| Distribution of overall survival (OS) by tumor site |  | Approximately 45 months | 
| Distribution of overall survival (OS) by treatment regimen |  | Approximately 45 months | 
| Number of treatment-limiting adverse events (AEs) | Incidence of important treatment-limiting adverse events (AEs) associated with systemic therapies | Approximately 45 months | 
| Number of withdrawals due to AEs |  | Approximately 45 months | 
| Proportion of diagnosis of another malignancy on or before the initial diagnosis of HNC |  | At Baseline |