linjc16/ctgov huggingface dataset:
Early Detection of Alzheimer's Disease and Affective Disorders by Automated Voice and Speech Analysis (PLATA)

Study Overview
=================
Brief Summary
-----------------
PLATA aims to develop an algorithm to identify vocal biomarkers of Alzheimer's dementia. Using data collected as part of routine care, speech patterns will be compared to known biomarkers of Alzheimer's disease, such as amyloid 1-42 and p-Tau in CSF (cerebrospinal fluid). If biomarkers of speech can be identified in Alzheimer's disease, it is possible that patients and research participants will no longer need to undergo need to undergo the intensive and invasive baseline biomarker methods currently used, such as lumbar punctures and PET scans.

Official Title
-----------------
Early Detection of Alzheimer's Disease and Affective Disorders by Automated Voice and Speech Analysis

Conditions
-----------------
Neurocognitive Disorders

Intervention / Treatment
-----------------
* Other: Series of cognitive tasks during a semi-automated call


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 50 years Diagnosis relevant biomarker and neuropsychological data already available Cognitively healthy to very mild dementia (CDR score max. 0.5) Sufficient knowledge of the study language to understand study information, non opposition form,and questionnaires Expression of non opposition Exclusion Criteria: Hearing problems Patient protected by law, under guardianship or curator ship, or not able to participate in a clinical study according to the article L.1121-16 of the French Public Health Code

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 100 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 |
| --- | --- |
| Patients with a minor or major neurocognitive disorder<br>Every patient will receive one semi-automated phone call, during the call a series of cognitive tasks will be performed. Each task will be recorded in a secondary audio stream which records the participant responses to allow for deep speech analysis of performance on these tasks | Other: Series of cognitive tasks during a semi-automated call<br>* Tasks: Verbal learning recall (immediate) or Story Recall task (immediate) Narrative Storytelling /free speech Verbal fluency task Verbal learning recall (delayed) or Story Recall task (delayed)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Build and validate speech-based machine learning models for relevant Phenotype detection through access to phenotyped patients from reference memory center. | Speech biomarker algorithm(s) | 20 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alzheimer's disease, Mood disorder
Study of MAR001 in Adults With Metabolic Dysfunction

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and tolerability of multiple doses of MAR001in adult volunteers with metabolic dysfunction.

Official Title
-----------------
A Phase 1b/2a Randomized, Double-Blind, Placebo-controlled Study of the Safety and Efficacy of MAR001 in Patients With Metabolic Dysfunction

Conditions
-----------------
Hypertriglyceridemia

Intervention / Treatment
-----------------
* Drug: MAR001
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Willingness to provide informed consent and comply with the intervention Women of childbearing potential and men agreeing to use an appropriate method of contraception for the duration of the study Evidence of metabolic dysfunction at screening (triglyceride levels > 2.8 mmol/L) Exclusion Criteria: Any condition which in the opinion of the investigator prevents the participant from complying with study procedures or prevents the participant from completing the study or interferes with the interpretation of study results Pregnant or breastfeeding mothers Terminal illness with expected survival of less than 1 year Note: additional inclusion/exclusion criteria may apply, per protocol

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: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MAR001<br>Subcutaneous injection | Drug: MAR001<br>* Subcutaneous injection<br>|
| Placebo Comparator: Placebo<br>Subcutaneous injection | Drug: Placebo<br>* Subcutaneous injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of MAR001 | Incidence and frequency of treatment-emergent adverse events | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of MAR001 on triglyceride metabolism | Change from baseline in triglyceride levels | 12 weeks |
No-biopsy Approach in Celiac Disease: Cut-off Points for IgA Anti-tissue Transglutaminase Assays

Study Overview
=================
Brief Summary
-----------------
The main objective of this multicenter and observational study is to define the optimal threshold of different commercially available IgA anti-transglutaminase (tTG-IgA) antibody assays for celiac disease diagnosis (CD) avoiding the need for an intestinal biopsy. The main questions to be answered are: Is the anti-tTG-IgA titer cut-off above 10 times the upper limit of normal (ULN) useful in all anti-tTG IgA assays? Is the diagnostic performance of the newly defined cut-offs of anti-tTG-IgA the same in all the evaluated assays? Is the dynamic of the anti-tTG-IgA levels after the introduction of the gluten-free diet (GFD) similar across the different assays included in the study? This is a prospective multicenter study that will enroll pediatric and adult patients with new-onset CD during the years 2023 and 2024. Serum from these patients will be collected for the determination of anti-tTG-IgA according to the local methodology (participating hospital) and by the anti-tTG IgA assays most commonly used in our country, which will be centralized in the same reference center (Hospital Universitario La Paz).

Official Title
-----------------
No-biopsy Approach for the Diagnosis of Celiac Disease: Definition of Cut-off Points for Different IgA Anti-tissue Transglutaminase Assays

Conditions
-----------------
Celiac Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patients, on gluten-containing diet, with TGt-IgA antibodies > Upper Limit of Normal (ULN) and intestinal biopsy confirming celiac disease (CD). Patients with TCRγδ+ >10% combined with decrease NK-like intraepithelial lymphocytes in the intestinal epithelium. Paediatric patients who meet ESPGHAN criteria (TGt-IgA antibodies >10xULN) without duodenal biopsy performed. Exclusion criteria: Patients already diagnosed with CD. Patients who refused duodenal biopsy. Patients with primary or secondary immunodeficiencies. Patients with malignancy. Recruited patients whose remaining serum cannot be sent to the reference centre, whose biopsies are of poor quality or who nod not sign the informed consent from.
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 |
| --- | --- | --- |
| Anti-transglutaminase-IgA titer | To define the optimal threshold for anti tTG-IgA levels using different commercially available assays that provide a positive predictive value of 100%. | The tTG-IgA will be measured at the time of patient recruitment and at the first follow-up (3-6 months from the start of the gluten-free diet). | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
anti-transglutaminase IgA, no-biopsy approach
Avis-PHAGEinLYON Clinic

Study Overview
=================
Brief Summary
-----------------
Avis-PHAGEinLYON Clinic study is a single site non-interventional retrospective and prospective study, initiated by the Hospices Civils de Lyon. Population targeted are patients referred to the Hospices Civils de Lyon for a medical advice for a phage therapy from 2015 to 2028. The primary objective is to quantify the phage therapy requests received at the Hospices Civils de Lyon. 1500 patients will be included in the study.

Official Title
-----------------
Avis-PHAGEinLYON Clinic

Conditions
-----------------
Bone Infection

Intervention / Treatment
-----------------
* Other: Phage therapy requests


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Patient referred to the Hospices Civils de Lyon for a phage therapy request from 01/01/2015 to 01/01/2028. Avis-PHAGEinLYON clinic study information notice provided to the patient Exclusion Criteria: - Opposition of trial participant
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Phage therapy requests|Quantification of phage therapy requests received at the Hospices Civils de Lyon from 2015 to 2028|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of phage therapy requests | Number of phage therapy requests received at the Hospices Civils de Lyon from 2015 to 2028 per year and per month. | at inclusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
medical advice, bacteriophage
Evaluation of the Novel Therapeutic Hepatitis B Virus Synthetic Long Peptide Vaccination ISA104

Study Overview
=================
Brief Summary
-----------------
The goal of this clinical trial is to test ISA104 in patients with chronic hepatitis B. The main question[s] it aims to answer are: How safe is ISA104? Does ISA104 induce immunity against hepatitis B virus? Different doses of the vaccine ISA104 will be administered to participants. These participants are chronic HBV patients being actively treated with antiviral drugs. Researchers will compare the ISA104 vaccine to a placebo.

Official Title
-----------------
Phase I/II Study to Determine the Safety, Immunogenicity and Efficacy of the Therapeutic Hepatitis B Virus Synthetic Long Peptide Vaccination ISA104

Conditions
-----------------
Chronic Hepatitis b

Intervention / Treatment
-----------------
* Drug: ISA104
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cHBV Active treatment with NUCs and HBV DNA < limit of quantification Exclusion Criteria: Immune-compromised Evidence of liver cirrhosis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ISA104<br> | Drug: ISA104<br>* SLP vaccine<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Saline solution (0.9% NaCl)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety according to AEs, SAEs | AEs, SAEs | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HBV specific Immunogenicity- following ISA104 vaccination | Number of IFN-y Elispots per well after 3 day stimulation with SLPs will correspond to immunogenicity. Elispots will be performed before (baseline) and after treatment | 6 months | 
| Efficacy of ISA104 vaccination by using conventional biomarkers | Levels of HBsAg, HBsAb, HBeAg, HBV DNA | 6 monts | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Immunotherapy, Therapeutic Vaccination, Hepatitis B cure
Manual Compression and Stretching for The Myofascial Trigger Points in Upper Trapezius and Levator Scapulae

Study Overview
=================
Brief Summary
-----------------
To compare the effectiveness of manual compression and stretching for myofascial trigger points in upper trapezius and levator scapulae in male office workers

Official Title
-----------------
Effectiveness Of Manual Compression and Stretching for The Myofascial Trigger Points in Upper Trapezius and Levator Scapulae

Conditions
-----------------
Myofascial Trigger Point Pain

Intervention / Treatment
-----------------
* Diagnostic Test: Manual Compression and Stretching


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male office workers with age of 25-45 working from Monday to Friday for 6-8 hours in a day. Exclusion Criteria: male office workers having any past trauma, chronic illness, any recent surgery and systemic diseases.

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Manual Compression and Stretching<br> | Diagnostic Test: Manual Compression and Stretching<br>* Manual Compression and Stretching for The Myofascial Trigger Points<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS (visual analogue scale) for pain | Stretching for The Myofascial Trigger Points in Upper Trapezius and Levator Scapulae using VAS | 6 Months | 
| mechanical algometer Scale for pain | Stretching for The Myofascial Trigger Points in Upper Trapezius and Levator Scapulae using mechanical algometer | 6 Months |
Hydrogen-Rich Water and Exercise-Related Biomarkers in Men and Women Over 50 Years

Study Overview
=================
Brief Summary
-----------------
The study investigates the impact of consuming hydrogen-rich water over a six-week period on exercise-related biomarkers among individuals aged over 50, both men and women, who undergo a resistance training program. This research aims to discern the potential benefits of hydrogen-infused water consumption concerning exercise-related markers in an aging demographic post-resistance training.

Official Title
-----------------
The Effects of Drinking Hydrogen-rich Water for 6 Weeks on Exercise-related Biomarkers in Men and Women Over 50 Years Following Resistance Training Program: a Randomized Controlled Pilot Trial

Conditions
-----------------
Aging

Intervention / Treatment
-----------------
* Dietary Supplement: Supplement
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 50 - 65 years (at least 50% would be over 60 years) Body mass index 18.5 - 29.9 kg/m2 Free of major chronic diseases or acute disorders Resistance exercise naïve (no resistance traiing during 6 months before study commences) Exclusion Criteria: History of dietary supplement use during the 4 weeks before study commences Unwillingness to return for follow-up analysis

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supplement<br>One tablet of hydrogen-rich supplement before breakfast and dinner | Dietary Supplement: Supplement<br>* Dietary supplement containing molecular hydrogen<br>|
| Placebo Comparator: Placebo<br>One tablet of hydrogen-free supplement before breakfast and dinner | Dietary Supplement: Placebo<br>* Inert substance<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 36-Item Short Form Health Survey | Short Form Health Survey total score | Change from baseline 36-Item Short Form Health Survey total score at 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Grip strength | Muscular strength generated by one's forearm muscles | Change from baseline grip strength at 6 weeks | 
| Myoglobin | Level of myoglobin in serum | Change from baseline serum myoglobine at 6 weeks | 
| Pittsburgh Sleep Quality Index | Pittsburgh Sleep Quality Index score | Change from baseline Pittsburgh Sleep Quality Index score at 6 weeks | 
| Dehydroepiandrosterone | Level of dehydroepiandrosterone in serum | Change from baseline serum dehydroepiandrosterone at 6 weeks |
Circadian Modulation of Grape Consumption and Oxidative Stress Response

Study Overview
=================
Brief Summary
-----------------
This study investigated the effects of time-of-day of grape consumption on high-fat meal-induced oxidative stress.

Detailed Description
-----------------
Grape consumption acts on the immune system to produce antioxidant and anti-inflammatory effects. Since immune activity demonstrates circadian rhythmicity, with peak activity occurring during waking hours, the timing of grape intake may influence the magnitude of its antioxidant effect. This study followed a 2 x 2 factorial randomized, controlled design wherein healthy men and women (n = 32) consumed either a grape or placebo drink with a high-fat meal in the morning or evening. Urine was collected for measurements of biomarkers of oxidative stress and grape metabolites at baseline and post-meal at hour 1 and hours 1-6

Official Title
-----------------
Circadian Modulation of Grape Consumption and Oxidative Stress Response

Conditions
-----------------
Oxidative Stress

Intervention / Treatment
-----------------
* Other: Grape


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Age 18-50 y Exclusion Criteria: Employed in shift or night work Extreme early or late chronotype Presence of acute infection or chronic inflammatory disease Smoking Heavy aerobic exerciser Greater than moderate alcohol intake Pregnancy or lactation Use of non-steroidal anti-inflammatory medications or antioxidant dietary supplements.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Time<br>Morning or evening | Other: Grape<br>* Reconstituted whole grape powder<br>|
| Experimental: Treatment<br>Grape or Placebo | Other: Grape<br>* Reconstituted whole grape powder<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urine F2-isoprostane | Oxidative stress marker | baseline | 
| Urine F2-isoprostane | Oxidative stress marker | hour 1 | 
| Urine F2-isoprostane | Oxidative stress marker | hours 1-6 |
Complications After Thyroid Surgeries: 10 Years' Experience

Study Overview
=================
Brief Summary
-----------------
Thyroidectomy is one of the commonest elective surgeries in surgical practice nowadays. It is associated with wide range of complications, from unnoticed events up to lifelong problems and even life-threatening complications. The most troublesome are bleeding, nerve injury and hypocalcemia. The current study was conducted to report the incidence and predictive factors for perioperative complications, aiming to point out preventive measures.

Detailed Description
-----------------
All files of all patients that had thyroidectomy in the hospital in the last 10 yeas will be reviewed. All demographic and peri-operative data will be collected, tabulated and analyzed. Incidence and pre-operative predictive factors of every single complication will pointed out and discussed.

Official Title
-----------------
Complications After Thyroid Surgeries: 10 Years' Experience

Conditions
-----------------
Thyroid

Intervention / Treatment
-----------------
* Procedure: Thyroidectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients had thyroid disease and performed thyroidectomy in the last 10 years in our hospital. Exclusion Criteria: Uncompleted files.

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Thyroidectomy|Thyroidectomy|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrent Laryngeal nerve injury | Recurrent Laryngeal nerve injury | 1 week | 
| Bleeding | intraoperative or post operative bleeding. | 2 days | 
| Hypocalcemia | Clinically significant low serum calcium level/ | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Thyroidectomy, Hypocalcemia, Stridor, Bleeding, Recurrent Laryngeal Nerve