linjc16/ctgov huggingface dataset:
Sofia Strep A FIA Field Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate the ability of the Sofia Strep A FIA test and Sofia Analyzer to accurately detect a throat swab specimen for the presence or absence of Group A Streptococcus when compared to culture.

Official Title
-----------------
Sofia Strep A FIA Field Study

Conditions
-----------------
Group A Streptococcus, Strep Throat

Intervention / Treatment
-----------------
* Device: In Vitro Diagnositc aid for diagnosis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Presence of sore throat Redness of the posterior pharyngeal wall Tonsillar exudate Tonsillar swelling Tender anterior cervical adenopathy Fever, > 38º C (100.4ºF) at presentation or within past 24 hours Other symptoms that may be present, in addition to above symptoms for GAS: Rash, typical of scarlet fever Abnormal tympanic membranes Palatal petechiae Exclusion Criteria: Subjects treated with antibiotics currently or within the previous week (7 days) are not to be included in this study. At clinical sites requiring informed consent, unable to understand and consent to participation; for minors this includes parent or legal guardian.

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: In Vitro Diagnositc aid for diagnosis|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
The Effects of Resveratrol Supplement on Biochemical Factors and Hepatic Fibrosis in Patients With Nonalcoholic Steatohepatitis

Study Overview
=================
Brief Summary
-----------------
To study the effects of Resveratrol supplement on lipid profile, liver enzymes, inflammatory factors and hepatic fibrosis in patients with Nonalcoholic Fatty Liver (NAfLD), 50 patients who referred to Gastrointestinal (GI) clinic with steatosis grade 1 or more will be randomly allocated to receive 1 Resveratrol capsules or placebos for 12 weeks; both groups will be advised to adherence our diet and exercise program too. At the first and the end of the intervention, lipid profiles, liver enzymes, some inflammatory cytokines, and liver fibrosis will be assessed and compared between groups.

Official Title
-----------------
The Effects of Resveratrol Supplement on Lipid Profile, Liver Enzymes, Inflammatory Factors and Hepatic Fibrosis in Patients With Nonalcoholic Steatohepatitis

Conditions
-----------------
Non Alcoholic Fatty Liver

Intervention / Treatment
-----------------
* Dietary Supplement: Resveratrol
* Other: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 and older; Evidence of nonalcoholic steatohepatitis with steatosis grade higher or equal to 1 in ultrasonography; No history of Alcohol consumption or consuming less than 10 grams alcohol per day in women and less than 20 grams per day in men; Absence of other liver disorders, malignancies, cardiovascular, respiratory, and kidney disorders; Absence of pregnancy or lactation; Absence of taking any medications in the past three months; Absence of weight loss in the recent three months; Absence of endocrine and metabolism disorders. Exclusion Criteria: Weight loss more than 10% of baseline body weight during the intervention period. Pregnancy; Disliking to continue the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Resveratrol<br>Active Comparator: Resveratrol 1 Resveratrol capsules for 12 weeks | Dietary Supplement: Resveratrol<br> <br> * Other names: 1 Resveratrol capsule per day for 12 weeks;|
| Placebo Comparator: Placebo<br>one capsule per day | Other: placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Alaninaminotransferase(ALT) |  | 12 weeks |
Creation of the Biobank Related to Eye Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to develop a BioBank (a specialized lab) and collect blood, fluids and/or other tissue samples to study eye diseases.

Detailed Description
-----------------
The purpose of the Biobank related to eye disease at Beaumont Hospital is to help connect specialties and Specialists with each other, outside traditional limits of hospital or laboratory departments. The specimens (blood, fluids, and/or tissue samples) that will be collected from men, women and children will assist the researchers in a variety of studies on human eye diseases. Research utilizing these specimens will allow for an increased understanding of the etiology, disease process, and response to treatments for various eye diseases, and will provide opportunities to subsequently improve our management decisions. Furthermore, projects that cross over between subspecialties are sparse and that is a limiting factor for the development of research that takes a more comprehensive approach.

Official Title
-----------------
Creation of the Biobank Related to Eye Disease

Conditions
-----------------
Eye Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All pediatric and adult patients age 0-99 years - Exclusion Criteria: All patients who do not agree to consent for collection of blood, fluids, tissue. Patients who are cognitively impaired and are not able to verbalize understanding of the risks/benefits. -
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 |
| --- | --- | --- |
| To build the platform for a novel application of translational research that links cutting edge molecular laboratory techniques to clinical outcome studies | Biobanks can be used for numberous discovery applications such as: identification and structural characterization of human genes, expression analysis, or discovery proteomics. Biological specimens, when coupled with standardized treatment and outcome data, will be essential resources for the identification, characterization and validation of biomarkers that are predictive of disease and treatment. |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Biobank, Genetics
Laparoscopic Sacrocolpopexy Versus POPS in the Management of Pelvic Prolapse

Study Overview
=================
Brief Summary
-----------------
This is the first study comparing the laparoscopic sacropexy with Pelvic Organs Prolapse Suspension (POPS) to treat pelvic organ prolapse. This prospective randomized surgical trial is designed to test the clinical and functional effects of the two different laparoscopic procedures in terms of anatomical correction of the prolapse, post-operative and long term morbidity, rate of recurrence and subjective satisfaction of the patient evaluated by a quality of life questionnaire.

Official Title
-----------------
Laparoscopic Sacrocolpopexy Versus POPS in the Surgical Management of Pelvic Organ Prolapse: A Prospective Randomized Trial

Conditions
-----------------
Pelvic Organ Prolapse

Intervention / Treatment
-----------------
* Procedure: Laparoscopic procedure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who required surgical treatment for symptomatic pelvic organ prolapse stage ≥ 2 with or without stress urinary incontinence Exclusion Criteria: Age > 70 years Severe cardiovascular or respiratory disease Pregnancy Previous surgical procedure for POP correction

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 70 Years

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sacral colpopexy<br>Laparoscopic procedure | Procedure: Laparoscopic procedure<br> <br> |
| Active Comparator: POPS<br>Laparoscopic procedure: Pelvic Organs Prolapse Suspension | Procedure: Laparoscopic procedure<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with anatomical correction of the prolapse | Anatomical correction of the prolapse evaluated by gynecological visit | up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of recurrence |  | up to 6 months | 
| Post operative quality of life | Subjective satisfaction of the patient evaluated by a quality of life questionnaire. | up to 6 months |
Investigating the Relationship Between Sleep, Quality of Life,Other Disorders and Therapies in MS Patients on Betaferon

Study Overview
=================
Brief Summary
-----------------
The study aims to investigate the relationship between sleep quality, quality of life,other disorders and therapies in Multiple Sclerosis (MS) patients treated with Betaferon.

Official Title
-----------------
BETASLEEP - SLEEP Quality and Functional Health Status, Fatigue, Comorbidities and Therapeutic Algorithms Among BETAferon® Treated MS Patients

Conditions
-----------------
Multiple Sclerosis

Intervention / Treatment
-----------------
* Drug: Interferon beta-1b (Betaferon, BAY 86-5046)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients ≥ 18 years of age with relapsing remitting multiple sclerosis or a clinically isolated syndrome and an expanded disability status scale score ≤5. Patients must be on treatment with Betaferon and tolerate Betaferon according to the investigator's evaluation, but should not have received Betaferon longer than six months. Written informed consent must be obtained Exclusion Criteria: Patients who do not tolerate Betaferon according to the investigator's evaluation or have been treated with Betaferon for more than six months. Patients receiving any other disease modifying drug or MS specific treatments Contraindications of Betaferon described in the Summary of Product Characteristics.

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 |
| --- | --- |
| Group 1<br> | Drug: Interferon beta-1b (Betaferon, BAY 86-5046)<br>* Patients will be followed-up for 24 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep quality will be assessed by the Pittsburgh Sleep Quality Index (PSQI) |  | up to 3 years | 
| Fatique assessed by the Modified Fatigue Impact Scale (MFIS) |  | up to 3 years | 
| Functional health status assessed by Short Form-36 (SF-36) |  | up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daytime sleepiness is measured with the Epworth Sleepiness Scale (ESS) |  | up to 3 years | 
| Depression and anxiety is measured with the Hospital anxiety and depression scale (HADS) |  | up to 3 years | 
| Pain is measured with the Hamburg Pain Adjective List (Hamburger Schmerz Adjektiv Liste (HSAL) |  | up to 3 years | 
| Severity of restless legs syndrome measured with the International Restless Legs Syndrome Study (IRLSS) group rating scale. |  | up to 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Multiple Sclerosis, Sleep, Observational study, Quality of life
Effect of Functional Relaxation on Patients Undergoing Colonoscopy

Study Overview
=================
Brief Summary
-----------------
Patient attending for colonoscopy are generally worried and anxious. Fear of discomfort is the most common reason for low acceptance of colonoscopy. Several methods have been used to minimize patient discomfort, including the use of paediatric colonoscopes, variable stiffness colonoscopes, gastroscopes, music, audio distraction, or simply allowing the patients to participate in administration of medication. Although a potential benefit from some of these methods has been suggested, no clear recommendations have been made so far. We hypothesized functional relaxation reduces discomfort during colonoscopy.

Official Title
-----------------
Effect of Functional Relaxation on Patients Undergoing Colonoscopy: A Prospective Randomized Controlled Trial

Conditions
-----------------
Colonoscopy, Relaxation

Intervention / Treatment
-----------------
* Procedure: Functional relaxation
* Procedure: No relaxation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient undergoing screening or surveillance colonoscopy Exclusion Criteria: Previous colorectal resection

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Functional relaxation<br>Functional relaxation | Procedure: Functional relaxation<br>* Functional relaxation during colonoscopy<br>|
| Active Comparator: No relaxation<br>No relaxation | Procedure: No relaxation<br>* No relaxation during colonoscopy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient's abdominal pain during colonoscopy |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction |  | 1 day |
Bisphosphonate Treatment of Osteogenesis Imperfecta

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this trial is to evaluate whether the investigational medication is safe, effective and has the ability to increase spine bone density in osteogenesis imperfecta (OI) patients.

Official Title
-----------------
Bisphosphonate Treatment of Osteogenesis Imperfecta

Conditions
-----------------
Osteogenesis Imperfecta

Intervention / Treatment
-----------------
* Drug: Zoledronic Acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Male or Female children between 3 months and 17 years old OI type I, III or IV Exclusion Deformity or abnormality which would prevent spine bone density from being done Any surgical bone-lengthening procedure Any kidney diseases or abnormalities Low calcium or vitamin D levels in the blood Other protocol-defined inclusion/exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 3 Months
Maximum Age: 17 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

| Intervention/Treatment |
| --- |
|Drug: Zoledronic Acid|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in lumbar spine bone mineral density at month 12 relative to baseline |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Z score of the lumbar spine at month 12 relative to baseline |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pamidronate, Osteogenesis Imperfecta, OI, bone markers, fracture, bone loss, pediatric, bisphosphonate, brittle bone disease
Repetitive Thoughts in Fibromyalgia: Impact of Rumination on the Emotional and Cognitive Dimensions of Fibromyalgia

Study Overview
=================
Brief Summary
-----------------
Dysfunctional chronic diffuse pain syndrome, concerning 2% of the French population, Fibromyalgia (FM) is classified either as a psychological disease or as a somatic disease. This dichotomous reasoning does not lead to a better understanding and does not allow the use or development of new psychological tools of care. The issue of the proximity between FM and depression highlighted by some authors and the presence of anxious comorbidities may arise at a different level, that of the transdiagnostic approach. Rumination is one of these transdiagnostic processes that are the subject of recent studies and one of the dimensions of which (abstract analytical rumination) is at work in depression and a number of psychopathologies. The investigator therefore wishes to explore the process of rumination and its abstract analytical dimension in FM and to explore its link with the depressive and anxious manifestations frequently associated with this disorder.

Official Title
-----------------
Repetitive Thoughts in Fibromyalgia: Impact of Rumination on the Emotional and Cognitive Dimensions of Fibromyalgia

Conditions
-----------------
Fibromyalgia

Intervention / Treatment
-----------------
* Other: Evaluate the link between an abstract / analytical thinking style and depressive manifestations in FM.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: FM Criteria of the American College of Rheumatology ACR 1990. Major Patients free and informed consent signed stable treatment for at least one month Native French speaker Patient covered by health insurance. Exclusion Criteria: Patient deprived of liberty or protected major (under guardianship or curatorship)

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patient with Fibromyalgia<br> | Other: Evaluate the link between an abstract / analytical thinking style and depressive manifestations in FM.<br>* Evaluate the link between an abstract / analytical thinking style and depressive manifestations in FM.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analyze the rate of rumination and depression of a fibromyalgia patient using a questionnaire | Analyze the rate of rumination and depression of a fibromyalgia patient using a questionnaire | 1 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rumination
Comparison of the Tibiofemoral Rotational Alignment After Mobile and Fixed Bearing Total Knee Arthroplasty

Study Overview
=================
Brief Summary
-----------------
The anatomic landmark for the anteroposterior (AP) axis of the proximal tibia and its variability was investigated in this study in order to determine whether a certain landmark could be employed as a reference axis for the proximal tibia after rotating platform mobile bearing (RP-MB) and fixed bearing (FB) total knee arthroplasties (TKAs).

Detailed Description
-----------------
Reference of tibial AP axis for implanting tibial component in total knee arthroplasty have not been concluded. This study can suggest appropriate method for alingning the tibial component to accurate tibial AP axis.

Official Title
-----------------
Comparison of the Tibiofemoral Rotational Alignment After Mobile and Fixed Bearing Total Knee Arthroplasty

Conditions
-----------------
Osteoarthritis

Intervention / Treatment
-----------------
* Device: total knee arthroplasty
* Device: total knee arthroplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary osteoarthritis Exclusion Criteria: infection inflammatory arthritis reoperation severe deformity
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: Mobile Bearing<br>Mobile bearing total knee arthroplasty | Device: total knee arthroplasty<br>* Mobile Bearing Total knee Arthroplasty<br>* Other names: Sigma® RP-F Knee System, Depuy J&J, Warsaw, IN, USA;|
| Active Comparator: Fixed Bearing<br>Fixed Bearing total knee arthroplasty | Device: total knee arthroplasty<br>* Fixed Total Knee Arthroplasty<br>* Other names: Nexgen® Legacy® Knee LPS-Flex, Zimmer, Warsaw, IN, USA;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tibial anteroposterior axis relative to femoral anteroposterior axis | Tibial anteroposterior axis relative to femoral anteroposterior axis on Computed tomogram images | postoperative 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Arthroplasty, Replacement, Knee, Rotational Alignment