linjc16/ctgov huggingface dataset:
A Study to Evaluate RIST4721 in Hidradenitis Suppurativa (HS)

Study Overview
=================
Brief Summary
-----------------
A Randomized, Double-blinded, Placebo-controlled, Phase 2a Study to Evaluate the Efficacy and Safety of RIST4721 in Subjects with Hidradenitis Suppurativa

Official Title
-----------------
A Randomized, Double-blinded, Placebo-controlled, Phase 2a Study to Evaluate the Efficacy and Safety of RIST4721 in Subjects With Hidradenitis Suppurativa

Conditions
-----------------
Hidradenitis Suppurativa

Intervention / Treatment
-----------------
* Drug: RIST4721
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of HS for at least 1 year prior to screening HS lesions must be present in at least 2 distinct anatomic areas A total AN count (sum of abscesses and inflammatory nodules) > 6 across all anatomical sites at both the screening and baseline visits Willing to use contraception for the duration of the study Exclusion Criteria: Presence of other skin conditions which may interfere with study assessments Presence of active, chronic or latent bacterial, viral, fungal mycobacterial infection (including latent TB) or history of infection within 4 weeks of screening Body Mass Index (BMI) >48kg/m2 Breastfeeding or pregnant

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RIST4721 400 mg<br>RIST4721 400 mg: 4 active (100 mg) tablets once daily for 12 weeks | Drug: RIST4721<br>* RIST4721 tablets, 100 mg are blue, oval, biconvex film-coated tablets<br>|
| Placebo Comparator: Placebo<br>Placebo: 4 placebo tablets once daily for 12 weeks | Drug: Placebo<br>* Matching placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of TEAEs |  | Baseline to Week 12 (or end of study participation) | 
| Incidence of SAEs |  | Baseline to Week 12 (or end of study participation) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Subjects Achieving HiSCR50 at Week 12 |  | Baseline to Week 12 |
HIV UPBEAT: Understanding the Pathology of Bone Disease in HIV-infected Patients.

Study Overview
=================
Brief Summary
-----------------
Despite the prevalence of osteopenia and osteoporosis in the HIV positive population, relatively little is known about the underlying pathology. This prospective cohort study aims to gain further understanding about a number of issues relating to low bone mineral density in HIV-infected subjects.

Detailed Description
-----------------
This study will follow HIV positive and negative subjects annually for 5 years. The aims of this study include: to describe the pathology underlying low bone mineral density to assess the relationship between low bone mineral density and antiretroviral therapy exposure to assess the relationship between low bone mineral density and vitamin D /PTH status and/or markers of bone metabolism to assess the relationship between osteopenia and subsequent changes in bone mineral density and markers of bone metabolism to assess the validity of the currently available fracture risk assessment tool in predicting fractures in HIV positive populations

Official Title
-----------------
HIV UPBEAT: Understanding the Pathology of Bone Disease in HIV-infected. A Prospective Cohort Study of HIV-infected Patients and HIV-negative Subjects.

Conditions
-----------------
Osteoporosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age >18 years be able to provide written, informed consent be able to attend the research centre in a fasting state and undergo DEXA scanning Exclusion Criteria: Subjects on bisphosphonate therapy at screening Pregnant or breastfeeding female subjects Subjects with a previous clinical history of primary hyperthyroidism or HIV negative subjects with elevated parathyroid hormone at screening HIV-negative subjects with a prior history of osteoporosis

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 |
| --- | --- |
| HIV positive<br> | |
| HIV negative<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone pathology | To describe abnormalities in bone pathology in bone biopsies from HIV-infected subjects with low bone mineral density by comparing biopsy indices to reference ranges. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rates of change in bone mineral density | To determine rates of change in bone mineral density in HIV-positive patients compared to HIV-negative controls | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Human immunodeficiency virus, low bone mineral density, osteopenia, osteoporosis, fracture
Effect of Fluid Oral Intake During Labour

Study Overview
=================
Brief Summary
-----------------
Fasting during labour is a usual conduct in many hospitals around the world (due to the theorical risk of bronchoaspiration). There is little evidence supporting this conclusion. Besides, there are several studies that suggest that food intake during labour can be associated with shorter labours and a lower cesarean rate. The aim of the investigators study is to show if the oral intake of fluids during labour can reduce the first stage of labour with minimum risk to the patient.

Official Title
-----------------
Fluid Oral Intake vs. Fasting During Labour: A Randomized, Controlled Trial.

Conditions
-----------------
Labor

Intervention / Treatment
-----------------
* Procedure: Diet
* Procedure: Fasting


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Gestational age > 37 weeks. Cervical dilation < 5 cms. Exclusion Criteria: Maternal pathologies (diabetes, heart disease, preeclampsia) Breech presentation or any other condition that is an indication of cesarean section. Premature rupture of membranes.
Sexes Eligible for Study
-----------------
Female

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: Oral intake of fluids<br>Intake of oral fluids during labour. | Procedure: Diet<br>* Oral intake of fluids during labour, from admission (dose: two cups of 8 ounces each of clear tea with little sugar).<br>|
| Placebo Comparator: Fasting<br>No intake of oral fluids during labour. | Procedure: Fasting<br>* No intake of fluids during labour.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of labour (measured in minutes from admission to delivery) |  | Two months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of cesarean sections due to prolonged second stage of labour (measured in number of cases). |  | Two months | 
| Number of cases of bronchoaspiration. |  | Two months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Food, Fluids, Labor
Detection of Airway Obstruction by Manometry in Different Sleep Stages and Comparing it to DISE

Study Overview
=================
Brief Summary
-----------------
Patients with OSA receive manometry measurements with Apneagraph (AG) during one night of sleep. All patients are simultaneously evaluated with polysomnography. Patients who are not eligible for CPAP therapy are additionally studied with drug-induced sleep endoscopy (DISE). The frequency and obstructions patterns in different sleep stages are assessed. In addition obstruction patterns detected with AG are compared with DISE examination in the selected cases.

Official Title
-----------------
Detection of Airway Obstruction by Manometry in Different Sleep Stages and Comparing it to DISE

Conditions
-----------------
Sleep Apnea Syndromes

Intervention / Treatment
-----------------
* Device: Manometry and possibly DISE


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Apnea-Hypopnea-Index (AHI) ≥ 5. Exclusion Criteria: age <18 years; body mass index (BMI) of >35 kg/m2; active infection; previous oral, head, or neck surgery in the last 3 months; pregnancy; chronic use of alcohol (> 60g ethanol per day or > 150g ethanol per week) or sedatives; illicit drug use; chronic obstructive pulmonary disease.

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 |
| --- | --- |
| Sleep apnea, Manometry and possibly DISE<br>Sleep apnea Patients recieved manometry measures and those who were not considered for CPAP Therapy recieved Drug induced sleep endoscopy. | Device: Manometry and possibly DISE<br>* A Manometry is performed on all patients. After it in some Patient DISE is followed<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of obstruction depending of sleep stage |  | 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparing the manometry findings to DISE |  | 1 Hour |
Optical Biopsy of Human Skin in Conjunction With Laser Treatment

Study Overview
=================
Brief Summary
-----------------
This study is to compare the ability of optical biopsy. Research can use light enters the skin, collected, analyzed by the computer, and a picture created for the pathologist to conventional histologic examination compare with the pathologist looking at the piece of tissue through a microscope makes the diagnosis.

Detailed Description
-----------------
The Optical measurements provide quantitative optical property values that reflect changes in tissue perfusion, oxygen consumption, and cell/matrix development. Each measurement requires less than 5 minutes to execute. The measurements will be taken before and after skin treatment.This non-invasive, non-contact technique has great potential as a means to diagnose different skin problems without the need to obtain a piece of tissue from the skin.

Official Title
-----------------
Optical Biopsy of Human Skin in Conjunction With Laser Treatment

Conditions
-----------------
Tattoos, Malignant Melanoma, Merkel Cell Carcinoma, Basal Cell Carcinoma, Squamous Cell Carcinoma, Atypical Nevi, Congenital Nevi, Seborrheic Keratosis, Paget's Disease, Dermatofibroma, Kaposi's Sarcoma, Port Wine Stain, Hemangioma, Scleroderma, Burns

Intervention / Treatment
-----------------
* Device: Optical Biopsy imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female age > 18 years Exclusion Criteria: current participation in any other investigational drug evaluation inability to understand and carry out instructions

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| Optical Biopsy<br>Optical Biopsy imaging | Device: Optical Biopsy imaging<br>* Optical Biopsy imaging<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| normal skin |  | 12 weeks |
Project EV Minus Regulatory Clinical Evaluation - System Accuracy, User Performance and System Use Evaluation

Study Overview
=================
Brief Summary
-----------------
Clinical Evaluation including System Accuracy, User Performance and System Use Evaluation of a new Blood Glucose Monitoring System.

Official Title
-----------------
Project EV Minus Regulatory Clinical Evaluation - System Accuracy, User Performance and System Use Evaluation

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Device: Blood Glucose Monitoring System.


Participation Criteria
=================
Eligibility Criteria
-----------------
Summary of Inclusion Criteria: Able to voluntarily provide written informed consent to participate in the study. User Performance Accuracy Testing Only: Self-Monitoring - Subject is currently performing unassisted self-monitoring of blood glucose. Exclusion Criteria: Female subjects who are pregnant or lactating. Subjects who, in the opinion of the Investigator, are unsuitable for participation in the study. User Performance Accuracy Testing Only -Prior involvement with the investigational BGMS being used in this study.

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Blood Glucose monitoring System (BGMS)<br>Intervention: Blood Glucose monitoring System (BGMS) Results obtained from the BGMS for UP and SA are compared to a reference instrument (YSI) | Device: Blood Glucose Monitoring System.<br>* In vitro diagnostic medical device<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| User Performance (UP) evaluation - blood glucose level: BGMS vs reference instrument. | UP evaluation of blood glucose monitoring systems compared to a reference instrument. Samples collected by subject and HCP ( HealthCare Professional) | Up to 1 hour | 
| System Accuracy (SA) evaluation - blood glucose level: BGMS vs reference instrument. | Accuracy verification of blood glucose monitoring systems compared to a reference instrument. Samples collected by HCP only. | Up to 1 hour | 
| System Use Evaluation - HCP ( HealthCare Professional) questionnaire | Assessing use of BGMS and supporting material by subject. | Up to 1 hour |
Use of a Monitor in ME/CFS

Study Overview
=================
Brief Summary
-----------------
The use of an activity monitor to determine increase or decrease of activity in patients suffering from chronic fatigue syndrome.

Detailed Description
-----------------
A cohort of 50 patients suffering from chronic fatigue syndrome will be given an informed release form. Have a signed the informed release they will be given a Fitbit activity monitor. These monitors will be evaluated on a weekly interval by computer interface. The activity will be calculated to determine the online of activity and whether there is increase or decrease in activity during the time of the study. The study is an observational rather than an interventional study. There is no invasion or intervention in the patient's normal activities

Conditions
-----------------
Chronic Fatigue Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fukuda and Canadian consensus criteria for the diagnosis of chronic fatigue syndrome Exclusion Criteria: Acute disease and exclusion conditions in Fukuda criteria

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| observation of activity level in CFS patients | observation of activity level in CFS patients using objective activity monitor | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic fatigue syndrome, CFS, myalgic encephalomyelitis, M.E., activity monitor
Wearable Robotic Upper Body Exoskeleton for Workers

Study Overview
=================
Brief Summary
-----------------
The main aim of the project is to evaluate a novel upper body exoskeleton during simulated industrial work. In a first stage of the project, an extensive study involving the end-user companies will be carried out to clearly identify the operator target tasks and typical target task loads for which the exoskeleton will be designed. Based on standard ergonomic evaluation scales (RULA and NIOSH, the Need for Recovery Scale and the Ovako Working Posture Analysing System), high risk tasks will be identified in the field, based on the evaluated information about the workspace configuration, the performed operations and their physical constraints. These will include, but will not be limited to, non-ergonomic postures, for example performing operations above the head or reaching in front, to the side, or behind the body; flexing the arms for extended periods of time; and bending or twisting the torso to lift an object from low or distant locations. Important items to assess in this task are the frequency and duration of tasks and activities, lifting characteristics, perceived physical effort and work-induced fatigue.

Official Title
-----------------
Ergonomic Evaluation of Workspaces and Occupational Tasks Targeted for Exoskeleton Support and Definition of Case Studies

Conditions
-----------------
Work-Related Condition, Physical Stress, Mental Fatigue

Intervention / Treatment
-----------------
* Other: Ergonomic evaluation using questionnaires


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Industrial employees - Exclusion Criteria: non-able bodied individuals
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 |
| --- | --- |
| Industrial employees<br>Ergonomic evaluation using questionnaires in different Industrial settings will be conducted and thus Industrial employees form the included subject group. | Other: Ergonomic evaluation using questionnaires<br>* Employees will be provided with questionnaires such as the 'Rapid Entire Body Assessment' and NIOSH to obtain information regarding ergonomic working situations<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questionnaire | Ergonomic evaluation Industrial work situations | The time point of data collection: An average of 1yr | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Industrial work, physical effort, mental effort, questionnaires, ergonomic evaluation
Diagnostic Value of Arterial Blood Gas Analysis in Prehospital Patients

Study Overview
=================
Brief Summary
-----------------
In the anesthesiologist-manned mobile emergency car unit an analyzing device for blood gas testing is present since 2014. This study will determine if a prehospital arterial blood gas helps the doctor to make more precise diagnosis prehospitally. Furthermore it will be determined if the doctors find this device helpful in assessing and treating patients with affected consciousness.

Official Title
-----------------
Diagnostic Value of Arterial Blood Gas Analysis in Prehospital Patients

Conditions
-----------------
Unconscious (Psychology)

Intervention / Treatment
-----------------
* Other: With arterial blood gas, parameters not being normal can be corrected


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: GCS < 13 Exclusion Criteria: Pregnant or breastfeeding detained or imprisoned patient

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 |
| --- | --- |
| Take arterial blood gas<br>Patients with impaired consciousness are randomised into having analysed a arterial blood gas. | Other: With arterial blood gas, parameters not being normal can be corrected<br>* If arterial blood gas is analysed answers provide the possibility to make more accurate diagnosis and treat specific abnormal parameters (e.g. electrolytes, oxygenation and so forth).<br>|
| Do not take arterial blood gas<br>Patients with impaired consciousness are randomised into not having analysed a arterial blood gas. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy | Will there be fewer observational diagnosis | 220 patients in 1.5 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Doctor satisfaction | Did the doctor find the arterial gas or lack of it affected the treatment and diagnosis | 220 patients in 1.5 year |