linjc16/ctgov huggingface dataset:
Disability and Health Outcomes in COPD

Study Overview
=================
Brief Summary
-----------------
To test a conceptual model of how disability develops in chronic obstructive pulmonary disease (COPD).

Detailed Description
-----------------
BACKGROUND: Background. COPD is a common chronic health condition. Because current medical treatments have minimal impact on disease progression, a strategy to prevent COPD-related disability would have important clinical and public health benefits. DESIGN NARRATIVE: The study will test a specific conceptual model of how disability develops in COPD. The aims are: (1) To evaluate the impact of respiratory impairment, especially pulmonary function impairment, on the risk of functional limitation in COPD. Using a control group, to elucidate the prevalence of respiratory impairment, functional limitation, and disability that is directly attributable to COPD. (2) In adults with COPD, to delineate the longitudinal effect of functional limitation on the risk of incident disability. The investigators hypothesize that development of functional limitation, and not pulmonary function impairment, is the major determinant of disability. (3) To determine the prospective impact of disability on the risk of future adverse health outcomes. The investigators will assemble a prospective cohort of 1200 randomly sampled adults with COPD who are members of a large regional health maintenance organization. A matched control group of 300 subjects will be recruited. Subjects will undergo a detailed physical assessment that measures respiratory impairment (e.g., pulmonary function) and functional limitation (e.g., lower extremity function, muscle strength, exercise performance, and cognitive function). Structured telephone interviews will ascertain disability outcomes at baseline and 18-month prospective follow-up. The investigators will also study the modulating effects of specific risk factors and protective factors on the progression from functional limitation to COPD-related disability, including psychological factors, environmental exposures, and health care process factors.

Official Title
-----------------
Disability and Health Outcomes in COPD

Conditions
-----------------
Chronic Obstructive Pulmonary Disease, Lung Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion: COPD diagnosis and Medication use for cases Exclusion: 1. Withdrew from Kaiser Plan prior to baseline contact

Ages Eligible for Study
-----------------
Maximum Age: 55 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 |
| --- | --- | --- |
| COPD Disability | Observational self-reported impairment in valued life activities. | 10 years |
Fat Distribution and Glucose Metabolism in Williams Syndrome

Study Overview
=================
Brief Summary
-----------------
Williams Syndrome (WS) is a genetic syndrome with features that may include vascular stenoses, neuro-developmental changes, and a variety of endocrine and metabolic abnormalities, including impaired glucose metabolism and abnormal body composition. Approximately 75% of adults with WS have impaired glucose tolerance or diabetes on oral glucose tolerance testing (OGTT). In addition, clinical observations and preliminary data suggest increased overall body fat in these individuals, as well as a relative increase in fat deposition in the lower extremities. However, glucose and lipid metabolism in WS remain incompletely characterized. The purpose of the current study is to carefully describe glucose metabolism and lipid parameters in people with WS.

Official Title
-----------------
Characterization of Fat Distribution and Glucose Metabolism in Individuals With and Without Williams Syndrome

Conditions
-----------------
Williams Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria M or F age 14-70yo Diagnosis of WS confirmed by FISH or chromosomal microarray (WS only) Availability of a parent or guardian to participate in the consent process (all WS, and controls <18yo) Exclusion Criteria History of weight loss surgery or liposuction Use of weight-lowering drugs Positive urine pregnancy test (females only) Obesity or abnormal fat distribution due to a known secondary cause (except WS) such as Cushing syndrome, HIV-infection, etc. Known diabetes will preclude administration of the OGTT but not participation in other aspects of the study.

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 70 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 |
| --- | --- |
| Williams Syndrome<br>Children and adults with Williams Syndrome | |
| Control Group<br>Controls will be recruited in 2 ways: 1) a gender matched and age- and BMI-similar control for each WS patient, and, 2) sibling controls when available | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2-hour glucose | Blood glucose concentration two hours after drinking a sugary drink (oral glucose tolerance test) | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent body fat | percent body fat as measured by whole body dual-energy xray absorptiometry (DXA) scanning | Baseline | 
| Low-density lipoprotein cholesterol (LDL) |  | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Williams Syndrome
Salivary and Serum Levels of Chemerin and MMP-9 in Oral Premalignant and Malignant Lesions

Study Overview
=================
Brief Summary
-----------------
45 individuals were subdivided into 3 groups, 15 patients with oral premalignant lesions, 15 patients with oral malignant lesions and 15 control individuals. Levels of chemerin and MMP-9 were evaluated in serum and saliva of these subjects utilizing the ELISA technique.

Detailed Description
-----------------
45 individuals were subdivided into 3 groups, 15 patients suffering from oral premalignant lesions, 15 patients suffering from oral malignant lesions and 15 individuals having age, gender and periodontal status matched with both patients groups acting as a control group. Serum and whole unstimulated saliva samples were collected from all the included groups in order to determine chemerin and MMP-9 in serum and saliva utilizing the ELISA technique.

Official Title
-----------------
Salivary and Serum Levels of Chemerin and MMP-9 in Oral Precancer and Oral Squamous Cell Carcinoma.

Conditions
-----------------
Precancerous Conditions, Oral Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with oral premalignant lesions. patients with oral malignant lesions. Exclusion Criteria: any systemic disease other than oral premalignant or malignant lesions. smokers. pregnant females. periodontal diseases.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 50 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 |
| --- | --- |
| oral premalignant patients<br>15 patients suffering from oral premalignant lesions as lichen planus, actinic keratosis, leukoplakia and erythroplakia. | |
| oral malignant patients<br>15 patients suffering from oral malignant lesions | |
| control subjects<br>15 individuals age, gender and periodontal status matched with oral premalignant and malignant patients and not suffering from any oral mucosal lesions or periodontal disease. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| salivary levels of chemerin in patients with oral premalignant and malignant lesions. |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum levels of chemerin in patients with oral premalignant and malignant lesions. |  | 1 day | 
| serum levels of MMP-9 in patients with oral premalignant and malignant lesions. |  | morning visit | 
| salivary levels of MMP-9 in patients with oral premalignant and malignant lesions. |  | 1 day |
Neo-Adjuvant Gemcitabine and Cisplatin in Treating Patients With Early Stage of Non Small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
Based on available data, the concept of neo-adjuvant chemotherapy seems to be promising for patients with resectable non-small cell lung cancer. The exploration of new drugs and regimens are warranted. Therefore the aim of this study is to evaluate the clinical response rate of neo-adjuvant chemotherapy with gemcitabine and cisplatin in patients with operable non-small cell lung cancer stage IB, IIA-B, IIIA.

Official Title
-----------------
Phase II Trial of Gemcitabine and Cisplatin as Neo-Adjuvant Chemotherapy for Operable Non-Small Cell Lung Cancer

Conditions
-----------------
Carcinoma, Non-Small-Cell-Lung Cancer

Intervention / Treatment
-----------------
* Drug: Gemcitabine
* Drug: cisplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: define histologic or cytologic diagnosis of non small cell lung cancer. determine the presence of clinical Stage IB, IIA-B or IIIA disease in accordance with the revision by Mountain CF of American Joint Committee on Cancer. define performance status of 0-1 on ECOG scale do not have any prior tumor therapy to be suitable for curative resection Exclusion Criteria: to have any treatment within the last 30 days with any investigational drug. to get concurrent administration of any other tumor therapy to be pregnant to have poorly controlled diabetes mellitus to have serious concomitant disorders.

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Gemcitabine|nan|
|Drug: cisplatin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the clinical response rate of neo-adjuvant chemotherapy with gemcitabine and cisplatin in patients with operable non small cell lung cancer |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety of neo-adjuvant chemotherapy with gemcitabine / cisplatin |  |  | 
| To determine the complete tumor resection rate |  |  | 
| To evaluate overall survival and time to documented disease progression |  |  |
Treatment of Post-poliomyelitis Syndrome by Intravenous Immunoglobulin

Study Overview
=================
Brief Summary
-----------------
Our study evaluates the efficacy of IGIV treatment in PPS on clinical (walking and pain) and isokinetic (muscle strength) criteria, on patients with PS at Montpellier's Hospital

Detailed Description
-----------------
Patients are admitted to a multidisciplinary consultation (neurologist, PMK) to validate the indication of treatment with IGIV. Realization of a pre-therapeutic evaluation in the department of MPR on the criteria of judgment, then the patient is admitted in a service of neurology to benefit from the cure of IGIV. The patient is then re-admitted to a PMR service for post-treatment evaluation. Collection of data retrospectively.

Official Title
-----------------
Treatment of Post-poliomyelitis Syndrome by Intravenous Immunoglobulin: a Retrospective Study of Efficacy on Clinical and Isokinetic Criteria

Conditions
-----------------
Post-Poliomyélitis Syndrom

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of PPS Pre- and post-therapeutic evaluation carried out Data transcribed in the computerized patient file Exclusion Criteria: No walking patient

Ages Eligible for Study
-----------------
Minimum Age: 30 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 |
| --- | --- | --- |
| Muscular strength | Muscular strength with isokinetic | 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Walking perimeter | Walking perimeter with walking test (6 minutes) | 5 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pre- and post-therapeutic evaluation carried out, Data transcribed in the computerized patient file, post-poliomyelitis syndrome, Intravenous immunoglobulins, walking test, isokinetics
Trial of Five Versus Six Fractions Per Week for Head and Neck Cancer

Study Overview
=================
Brief Summary
-----------------
This trial compares the use of 6 fractions versus the standard 5 fractions of radiotherapy used in the treatment of head and neck cancer.

Detailed Description
-----------------
The purpose of this trial is to study the clinical effects of increasing the weekly fraction number for locally advanced head and neck cancers by a multi-institutional prospective randomised trial. The primary endpoint is to clarify whether a six fraction per week protocol has a greater effect on the survival, as compared to the conventional five fraction per week protocol.

Official Title
-----------------
Phase III Trial of Five Versus Six Fractions Per Week for Head and Neck Cancer

Conditions
-----------------
Head and Neck Cancer

Intervention / Treatment
-----------------
* Radiation: Accelerated Radiotherapy Fractionation
* Radiation: Accelerated Radiotherapy Fractionation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Head and Neck Cancer Exclusion Criteria: Unable to give an informed 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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Radiotherapy: 6 Fractions<br> | Radiation: Accelerated Radiotherapy Fractionation<br>* Radiation Therapy 6 fractions per week<br>|
| Active Comparator: Radiotherapy: 5 fractions<br> | Radiation: Accelerated Radiotherapy Fractionation<br>* Radiotherapy 5 fractions per week<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Three Years Loco-regional Control |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-specific Survival |  | 8 years | 
| Overall Survival |  | 8 years | 
| Acute Adverse Effects |  |  | 
| Late Adverse Effects |  | 8 years |
Observational Study to Investigate the Long-term Effects of MIRCERA in Clinical Routine

Study Overview
=================
Brief Summary
-----------------
This observational study will assess the effect of long-term treatment with Mircera (methoxy polyethylene glycol-epoetin beta) in chronic kidney disease patients with renal anemia. Data will be collected from each patient for at least 24 months.

Official Title
-----------------
Non-interventional Study to Investigate the Long Term Effects of MIRCERA in Clinical Routine

Conditions
-----------------
Anemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients, >/= 18 years of age Patients with chronic kidney disease (CKD), stages IV and V Treatment with Mircera according to label Exclusion Criteria: Pregnant or breastfeeding women

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 |
| --- | --- |
| Cohort<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin Levels at Monthly Intervals | Hemoglobin levels were measured as grams/deciliter (g/dL). | Prior to Day 1, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | 
| Percentage of Participants Within Pre-defined Range of Hemoglobin Values | Percentage of participants with hemoglobin values within the following pre-defined ranges is presented: 11-12 gram/deciliter (g/dL), 10-12 g/dL, 11-13 g/dL, and 10-13 g/dL. | Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 | 
| Average Methoxy Polyethylene Glycol-epoetin Beta Dose | Average methoxy polyethylene glycol-epoetin beta dose per application by study month. Mean values were taken when more than 1 application was documented for a participant during the time period considered. | Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, and 24 |
A Study of VIS410 to Assess Safety and Pharmacokinetics

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety, tolerability, immunogenicity and pharmacokinetics of single escalating doses of VIS410 in healthy volunteers.

Official Title
-----------------
Double-Blind, Placebo-Controlled, Dose-Escalation Phase 1 Study in Healthy Volunteers to Evaluate the Safety and Pharmacokinetics of a Human Monoclonal Antibody (VIS410) to Influenza Type A Hemagglutinin

Conditions
-----------------
Influenza

Intervention / Treatment
-----------------
* Drug: VIS410
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers Body mass index between 18 and 33 kg/m2, inclusive Normal labs Volunteers agree to use acceptable contraceptive measures Exclusion Criteria: Prior receipt of antibody or biologic therapy History of cancer, heart disease, diabetes, respiratory condition (eg asthma), autoimmune disorder, blood dyscrasias Any chronic condition requiring daily prescription or over the counter medication History of a previous severe allergic reaction Drug or alcohol abuse within previous 12 months Positive serology for human immunodeficiency virus (HIV) antibody, hepatitis C virus (HCV) antibody or hepatitis B surface antigen (HBsAg) Positive pregnancy test Breast feeding Positive drug or alcohol test at screening or check-in Receipt of licensed vaccine (within 30 days) or other investigational product within 30 days or 5 half-lives, whichever is longer, before study product administration

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: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VIS410<br>VIS410 administered as a single infusion with ascending dose-escalation ranging from 2 to 50 mg/kg | Drug: VIS410<br> <br> |
| Placebo Comparator: Placebo<br>Placebo administered as a single infusion | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety assessment | Incidence of adverse events | 120 days post-infusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic analysis | Serum concentration-time profile | 56 days post-infusion | 
| Immunogenicity | Detect and measure anti-drug antibodies to VIS410 | 120 days post-infusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Influenza, Monoclonal antibody
Does Goal Elicitation Improve Patient Perceived Involvement

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if goal elicitation among orthopaedic patients improves their perceived involvement in care.

Detailed Description
-----------------
This is a RCT with 2 intervention arms. In the first arm, the control arm, patients will be asked to complete a short questionnaire after their visit, to elicit demographic information and perceived involvement in care. The second arm, the intervention arm, will be asked to list 2 goals for their visit and complete a short questionnaire after their visit, to elicit demographic information and perceived involvement in care.

Official Title
-----------------
Does Goal Elicitation Improve Patient Perceived Involvement?

Conditions
-----------------
Orthopedic Disorder

Intervention / Treatment
-----------------
* Other: Goal elicitation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: New patients visiting the orthopaedic service English fluency and literacy Exclusion Criteria: Returning patients Children Non-English speaking patients

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: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients will be randomized into 1 of 2 study arms arm 1: control arm 2: intervention. We will use a random block generator to assign participants to their study arm.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Patients in the control group will be asked to complete a demographics survey and assess their perceived involvement in care after their visit | |
| Experimental: Goal elicitation<br>Patients in the intervention group will be asked to list 2 goals for their visit. They will also be asked to complete a demographics survey and access their perceived involvement in care after their visit. | Other: Goal elicitation<br>* Patients will be asked to list 2 goals for their visit<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived Involvement in Care Scale (PICS) | PICS measures the following: doctor facilitation of patient involvement, level of information exchange, and patient participation in decision making. Scale: 0-13, higher score means higher perceived involvement. | Immediately after visit |