linjc16/ctgov huggingface dataset:
Help Arthritis With Exercise in West Virginia

Study Overview
=================
Brief Summary
-----------------
The purpose of this project is to determine if an evidence-based, community-delivered physical activity program, EnhanceFitness, yields benefits for participants with arthritis. The 3-year project will: 1) conduct a meta-analysis of community-based exercise programs for adults, 2) implement and evaluate the EnhanceFitness program in West Virginia using a randomized, controlled (wait list) design, and 3) disseminate the results to community and public health partners. It is anticipated that participation in the EnhanceFitness program will result in reduced pain, improved physical function and physical activity levels for adults with arthritis.

Official Title
-----------------
Arthritis Benefits of a Physical Activity Program in West Virginia: Evaluation of EnhanceFitness

Conditions
-----------------
Arthritis

Intervention / Treatment
-----------------
* Behavioral: 12-weeks EnhanceFitness
* Behavioral: Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 and older Any type of self-reported, doctor-diagnosed arthritis Exclusion Criteria: Any co-existing conditions where exercise is a contraindicated Impaired cognitive status Non-ambulatory

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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: Exercise<br>Subjects will be randomized to exercise (12 week EnhanceFitness class) or a wait-list control group. | Behavioral: 12-weeks EnhanceFitness<br>* EnhanceFitness class for 12 weeks, 3 times per week for 1 hour sessions.<br>|
| Other: Control<br>Wait-list control group will receive intervention after 12-weeks. | Behavioral: Control<br>* Participants randomized to the wait-list control group will continue their regular activities for 12 weeks and then be offered the exercise intervention (EnhanceFitness).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Severity |  | 8 months | 
| Physical activity level |  | 8 months | 
| Physical Function |  | 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health-related quality of life |  | 8 months | 
| Arthritis self-efficacy |  | 8 months | 
| Self-efficacy for exercise |  | 8 months | 
| Exercise perceptions |  | 8 months | 
| Social support |  | 8 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Arthritis, Osteoarthritis, Rheumatoid Arthritis, Fibromyalgia, Lupus
Multigen Plus H Study

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to assess the clinical, patient-reported, and radiographic outcomes of a revision Total Knee Arthroplasty with Multigen Plus H.

Official Title
-----------------
A Prospective, Post-marketing Study Evaluating Clinical and Radiographic Early Outcomes of Revision Total Knee Arthroplasty With Multigen Plus H.

Conditions
-----------------
Arthroplasty, Replacement, Knee

Intervention / Treatment
-----------------
* Device: Revision Total Knee Arthroplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female Age ≥ 18 years old Given written informed consent approved by the reference Ethics Committee (EC) Subjects in whom a decision has already been made to perform a revision Total Knee Arthroplasty with Multigen Plus H system as per Indication For Use. The decision to implant the Multigen Plus H system must be taken prior to, and independently from, the decision to enrol the subject. This decision should be made in accordance with routine standard of care at the study site. Subject is able to comply with the protocol Exclusion Criteria: Age < 18 years old Subjects with any Multigen Plus system contraindication for use as reported in the current Instruction For Use Any clinically significant pathology based on the medical history that the Investigator feels may affect the study evaluation Female subjects who are pregnant, nursing, or planning a pregnancy

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 |
| --- |
|Device: Revision Total Knee Arthroplasty|Total Knee Arthroplasty in case of failure of a previous operation.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional Knee Society Score (KSS) | Evaluation of the changes in the Functional Knee Society Score (KSS) after revision TKA | Month 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| KOOS-ADL (Function in Daily Living subdomain) | Evaluation of the functional changes in the KOOS-ADL domain after revision TKA | Month 24 | 
| VAS Pain score | Evaluation of the changes in the VAS Pain score after revision TKA | Month 24 | 
| Survivorship of the implant | Kaplan-Meier estimate | Month 24 | 
| Radiographic implant evaluation and stability assessment | Evaluation of progressive Radiolucent Lines after revision TKA | Month 24 | 
| Safety evaluation | Incidence, type, and severity of all the Adverse Events (AEs) occurred after revision TKA | Intra-operatively, Month 3, Month 12, and Month 24 |
Sun Protection Factor Assay (338/2016)

Study Overview
=================
Brief Summary
-----------------
To evaluate the Sun Protection Factor efficacy on human skin.

Official Title
-----------------
Sun Protection Factor (SPF) Assay: UVA Protection Factor Assay Minimal Persistent Pigment-Darkening Dose

Conditions
-----------------
Sunscreening Agents

Intervention / Treatment
-----------------
* Drug: BAY987521
* Drug: SPF Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing. Male and female. Aged between 18-70 years old. Good health as determined from the HRL SHF (Subject History Form). Signed and dated Informed Consent Form. Signed and dated HIPAA (Health Insurance Portability and Accountability Act) form. An unambiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose) Exclusion Criteria: Subjects on test at any other research laboratory or clinic. Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light. Pre-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.)which would interfere with this study. Pre-existing other medical conditions (e.g. adult asthma, diabetes). Treatment with antihistamines or corticosteroids within one week prior to initiation of the test. Treatment with antibiotics within two weeks prior to initiation of the test. Chronic medication which could affect the results of the study. Known pregnant or nursing women.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SPF evaluation<br>Each test site area is divided into test sub site areas that are approximately at least 0.5 cm*2. The application of test material is 2 mg/cm*2. Thus, each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. | Drug: BAY987521<br>* Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. (Formulation Code: Z11-004)<br>Drug: SPF Control<br>* Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minimal Erythema Dose (MED) |  | Up to 15 minutes | 
| Minimal Persistent Pigment Darkening Dose (MPPD) |  | Up to 15 minutes |
Sautour PHRC IR 2008

Study Overview
=================
Brief Summary
-----------------
Fusarium are microscopic filamentous fungi that live as saprobiontics in outside environments. They are found in the soil, the air, in water and on numerous plants. The frequency of fusariosis is currently increasing and Fusarium-related mycoses are the 3rd most frequent invasive mycoses. Most cases have been reported in the United States, in France, in Italy and in Brazil. A few epidemiological studies have shown the role of water in the appearance of mycoses in highly immunodepressed patients. Few studies have focused on the role of water in the transmission of mycoses in hospitals. The aim of this prospective study is to describe, in time and pace, the contamination by Fusarium sp. in the water of two different hospitals (Dijon, Nancy), by taking into account factors such as seasons and major works (reconstruction of a hospital). In each hospital, one reconstruction site will be compared with a site not under reconstruction (control). Water samples will be taken from the rooms of hospitalized patients.

Official Title
-----------------
Fungal Contamination of a Hospital Water System With Fusarium App.: Prospective Environmental and Medical Surveillance During a Construction Period

Conditions
-----------------
Mycosis

Intervention / Treatment
-----------------
* Other: water samples


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients with new-onset fusariosis in the Adult Haematology, Internal Medicinie, Digestive Surgery and Rheumatology Departments Exclusion Criteria: none
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| with construction work<br> | Other: water samples<br> <br> |
| without construction work<br> | Other: water samples<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of Fusarium sp |  | every week throughout the study, thus over 3 years |
COVID-19 and Vaccination Attitudes

Study Overview
=================
Brief Summary
-----------------
The investigators want to study how the exposure to the covid-19 pandemic affects attitudes towards science and vaccination, and how other general attitudes and values are affected.

Detailed Description
-----------------
The investigators will carry out a survey in the UK, asking the same 3 questions on vaccination as in a past survey in late 2019 to the same previous respondents, supplementing this with further questions on covid-19 exposure and attitudes towards, among others, individualism-collectivism, health policy as well as trust in science and institutions.

Official Title
-----------------
COVID-19 and Vaccination Attitudes

Conditions
-----------------
COVID-19

Intervention / Treatment
-----------------
* Other: Survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All volunteers who participated in the November 2019 survey on vaccination will be contacted. Exclusion Criteria: People who have not participated in the November 2019 survey People unwilling to participate again
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 |
| --- | --- |
| 1<br>Survey respondants | Other: Survey<br>* Survey<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| How vaccination and other attitudes are affected by COVID | Survey | Over last six months |
Treatment of Alzheimer's and Dementia With the Metabolism, Infections, Nutrition, Drug Elimination (MIND) Protocol

Study Overview
=================
Brief Summary
-----------------
Treating with measures that may improve metabolic functioning of neurons in an integrated protocol

Detailed Description
-----------------
Most organ failure results in modest drops in function until over 50% of function is lost. At a certain point, even modest drops in physiologic activity result in dramatic drops in clinical function. Though less homogeneous than in other organs, clinical experience and the literature suggests a similar process occurs in the brain. The hypothesis is that by using an integrated protocol to, essentially, tune up neuronal function, a 5-10 % improvement in metabolic functioning may translate to significant improvement in clinical functioning. This tune-up will include MIND: M- Metabolism-- optimizing hormonal function I- Infections-- looking for and eliminating N- Nutritional and herbal support D- Drugs- Weaning subjects off unneeded medications

Official Title
-----------------
Effective Treatment of Alzheimer's and Dementia With the MIND Protocol

Conditions
-----------------
Alzheimer's Disease, Dementia

Intervention / Treatment
-----------------
* Other: A mix of natural treatments and medications


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A diagnosis of Alzheimer's and/or dementia with an MMSE score over 12 or being ambulatory and able to travel outside the home with assistance. Must have a caregiver living with them. Exclusion Criteria: Overt progressive and severe causes of secondary dementia such as metastatic brain cancers, or severe overt infectious encephalopathies or severe autoimmune illness. Also, severe life threatening illnesses which would make them unlikely to be alive after 6-12 months
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: Treatment with MIND<br> | Other: A mix of natural treatments and medications<br> <br> * Other names: MIND Protocol;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Montreal Cognitive Assessment (MoCA) | Looking to see what percent of patients show improvement | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mini Mental Status Exam (MMSE) |  | 6 months | 
| Alzheimer's Disease Assessment Scale- Activities of Daily Living (ADAS-ADL) |  | 6 months |
Effect on Cognitive Function of a Treatment With Aripiprazole

Study Overview
=================
Brief Summary
-----------------
To evaluate the effectiveness of Aripiprazole after 12 weeks of therapy for Schizophrenic patients.

Official Title
-----------------
A Prospective, Multicenter, Open-Label Study to Evaluate the Effectiveness and the Effect on Cognitive Function of a Treatment With Aripiprazole in a Board Range of Schizophrenic Patients

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: Aripiprazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Schizophrenia score of 2-6 in the CGI-S scale at basline ambulatory or hospitalized subjects having symptoms which requires antipsychotic treatment Exclusion Criteria: women of child bearing potential women pregnant or breast feeding patients with a score of 0,-1 or 7 substance use

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Switch<br> | Drug: Aripiprazole<br>* Tablets, oral, 15 mg, once daily, 12 weeks.<br>* Other names: Abilify;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impression scale at endpoint |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Clinical Global Impression scale and cognition scales at endpoint |  |  |
Appropriate Number of Endotracheal Intubation Experience for CPR

Study Overview
=================
Brief Summary
-----------------
This is a clinical study based on analysis of video-clip data of intubation and clinical data for cardiopulmonary resuscitation patients between 2011.03.01.-2012.02.28.. Aim of this study is to estimate the appropriate number of endotracheal intubation(ETI) experience for successful ETI at first attempt during cardiopulmonary resuscitation.

Detailed Description
-----------------
Endotracheal intubation(ETI) has been considered to be the best method of airway management during cardiopulmonary resuscitation(CPR). However, ETI during CPR requires high skill and experience. Therefore ETI during CPR should be performed by expert in ETI. But the definition of experts in ETI during CPR has not been done yet. This study tried to estimate the appropriate number of ETI experience for successful ETI at first attempt during cardiopulmonary resuscitation. So the investigators analyze the success rate, speed, trial number, incidence of complications, and hands-off time of ETI using direct laryngoscopy (DL) which is standard device, in real clinical setting. In addition, this study analyze the residency training term, total number of ETI experience using DL at that time.

Official Title
-----------------
Appropriate Number of Endotracheal Intubation Experience for First Attempt Successful Endotracheal Intubation During Cardiopulmonary Resuscitation

Conditions
-----------------
Cardiopulmonary Arrest

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who suffer sudden cardiac arrest Exclusion Criteria: case of requesting the do-not-attempt resuscitation befor ETI intubated cases before arrival to emergency department

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 |
| --- | --- | --- |
| Successful intubation during CPR | endotracheal intubation, hands-off time < 10 seconds, first trial | successful endotracheal intubation with in 120 seconds | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intubation, cardiopulmonary resuscitation, number of endotracheal intubation experience
The Effects of Crocin Supplementation on Metabolic Parameters, Oxidative Stress, AMP- Activated Protein Kinase and Inflammation-promoting Genes Expression in Peripheral Blood Mononuclear Cells in Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
To study the effects of crocin supplement in patients with type 2 diabetes, 50 patients will be randomly allocated to placebo group and 2 tablets of crocin for 12 weeks. At the first and the end of the intervention, lipid profiles, blood pressure, blood sugar, inflammatory and anthropometric factors will be assessed and compared between groups.

Official Title
-----------------
The Effects of Crocin Supplementation on Metabolic Parameters, Oxidative Stress, AMP- Activated Protein Kinase and Inflammation-promoting Genes Expression in Peripheral Blood Mononuclear Cells in Patients With Type 2 Diabetes

Conditions
-----------------
Type 2 Diabetes

Intervention / Treatment
-----------------
* Dietary Supplement: crocin
* Dietary Supplement: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age of 40 to 65 years type 2 diabetes: and body mass index range of 18.5 to 30 kg/m2 Exclusion Criteria: pregnancy or lactation A history of Cardiovascular disease, Pulmonary disease, Renal disease

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 65 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br> | Dietary Supplement: placebo<br>* 2 tablets placebo per day<br>|
| Active Comparator: crocin<br> | Dietary Supplement: crocin<br>* 2 tablets crocin per day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| type 2 diabetes | number of participants with normal plasma glucose | 12 weeks |