linjc16/ctgov huggingface dataset:
Treatment of Androgenetic Alopecia in Males and Females

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy of Low Level Laser and Light Therapy system configured in a novel product called the TopHat 655 system, for promoting hair growth in males and females diagnosed with androgenetic alopecia of the head.

Official Title
-----------------
The Growth of Human Scalp Hair Mediated By Visible Red Light Laser and LED Sources.

Conditions
-----------------
Androgenetic Alopecia

Intervention / Treatment
-----------------
* Device: TopHat 655 rejuvenation system
* Device: Laser and/or Light Hair Rejuvenation System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of androgenetic alopecia Fitzpatrick Skin Phototypes I-IV Norwood-Hamilton IIa to V for males and Ludwig I or II for females Active hair loss within the last 12 months Willingness to refrain from using all other hair growth products or treatments In overall general good health as determined by the physician investigator Exclusion Criteria: Photosensitivity to laser light and non-laser LED light operating at 655nms. Malignancy in the target treatment area Other forms of alopecia of the head Past medical history of a collagen-vascular disease, thyroid disease or other cutaneous or systemic disease that seriously effects the scalp Unwillingness to remove hair replacement products during the therapy sessions Using any medications deemed to inhibit hair growth as determined by the physician investigator

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Red Incandescent light source<br> | Device: Laser and/or Light Hair Rejuvenation System<br>* A red incandescent light source replaces all lasers and light emitting diodes.<br>|
| Active Comparator: TopHat 655<br> | Device: TopHat 655 rejuvenation system<br>* TopHat 655 system is to be applied every other day for 16 weeks for a pre-programmed time period<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage Increase of Terminal Hairs from Pre-treatment, Baseline Count |  | After 16 weeks of therapy |
A Comparative Study of Brain Structure and Amyloid Load in MCI Patients

Study Overview
=================
Brief Summary
-----------------
Older people with DM are at greater risk of cognitive decline than their counterparts with DM. Cognitive impairment in older people with DM may be associated with non-AD related brain atrophy and white matter disease. The investigators therefore propose to compare DM and non-DM older people with amnesic MCI in brian volumes, white matter disease and amyloid load. 30 older people with aMCI, 30 older people with aMCI and DM, age 65-85 will be recruited. They all will have amyloid PET scan and MRI brain scan.

Official Title
-----------------
A Comparative Study of Brain Structure and Amyloid Load Between Cognitively Impaired Older People With or Without Diabetes Mellitus

Conditions
-----------------
Mild Cognitive Impairment

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: MCI patients Exclusion Criteria: Patients with depression

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 85 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 |
| --- | --- | --- |
| Amyloid load |  | Two years |
Evaluation of Failure Rate of Molar Tube With a Modified Bonding Technique

Study Overview
=================
Brief Summary
-----------------
Comparing between the failure rates of molar tubes bonded with conventional bonding technique using resin adhesive and the alternative bonding technique using compomer (containing glass ionomer) adhesive by adding a layer of compomer adhesive at the molar/tube interface.

Official Title
-----------------
Evaluation of Failure Rate of Molar Tube With a Modified Bonding Technique: A Randomized Clinical Trial

Conditions
-----------------
Molar Tube Bonding

Intervention / Treatment
-----------------
* Procedure: modified bonding technique


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients requiring fixed appliance orthodontic treatment (with no previous orthodontic treatment). Patients aged >12 years with full permanent dentition (excluding third molars). Intact buccal enamel surface of the molars without any of the following: Caries, abrasion, or any other crown defect (like hypoplasia). Pretreatment chemical agents. Restorations or fractures. Morphological modifications or other crown alterations. Patients who have the desire and ability to comply with the trial protocol. Exclusion Criteria: Treatments with planned extraction of first permanent molars. Occlusal interference that prevents correct position of molar tube. Patients with a craniofacial anomaly (like cleft lip and palate) and/or require orthognathic surgery. Patients that require extra-oral or intra-oral anchorage device (headgear, palatal arch, lingual arch) or expander (quad-helix, hyrax). Lack of consent to participate in the trial.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years

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

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

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 |
| --- | --- |
| No Intervention: conventional<br> | |
| Experimental: modified<br> | Procedure: modified bonding technique<br>* adding a layer of compomer adhesive at the molar/tube interface.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| failure rate of molar tubes | measuring failure rate of molar tubes bonded with modified bonding technique | 9 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
molar tube, failure rate
Use of Benzodiazepines and Z Drugs in the Elderly

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate benzodiazepines and related drugs (zolpidem and zopiclone) usage in an outpatient population of chronic users over 65 years in France using a questionnaire assessing substance dependence according to DSM-IV (Diagnostic and Statistical Manual of mental disorders) international standards.

Detailed Description
-----------------
1100 patients will be recruited by pharmacists. They will answer to a standardized questionnaire assessing their benzodiazepines or related drugs usage (phone contact). Pharmacists are recruited by all French Centers For Evaluation and Information on Pharmacodependence (CEIP).

Official Title
-----------------
Assessment of Problematic Use of Benzodiazepines and Z Drugs in the Elderly in France: a Public Health Issue

Conditions
-----------------
Chronic Benzodiazepines and Related Drugs Users

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 65 years old or more, benzodiazepines or benzodiazepines related drugs treatment for at least three months, written consent and without exclusion criteria. Exclusion Criteria: no written consent form difficulties to understand or speak french

Ages Eligible for Study
-----------------
Minimum Age: 65 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 |
| --- | --- |
| volunteers<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dependence according to DSM IV criteria |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| withdrawal syndrome |  | 2 years | 
| psychiatric comorbidities |  | 2 years | 
| Dependence scores |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
elderly, CEIP, pharmacodependance, addictovigilance, benzodiazepines and benzodiazepines related drugs
Taste Disturbance After Middle Ear Surgery: Frequency, Duration, Influence of Chorda Tympani Injury and Quality of Life

Study Overview
=================
Brief Summary
-----------------
Chorda tympani nerve (CTN), is a branch of nerve VII, and has two componants: taste sensation from the anterior two thirds of the tongue and salivary secretion from submandibular and sublingual salivary glands. CTN go throw middle ear between malleus and incus. Due to it anatomic localization, CTN is frequently damage during otologic surgery. Taste disturbance after middle ear surgery has been describe in literature but results of the various studies are very heterogenous. Moreover, there is no consensus to preserved or sacrificed a traumatize CTN. We will use questionnaire to evaluate frequency, duration and characteristics of taste disturbance after ear surgery and the impact on the quality of life for those with symptoms. We will evaluate the Influence of type of CTN injury on taste disturbance.

Official Title
-----------------
Taste Disturbance After Middle Ear Surgery: Frequency, Duration, Influence of Chorda Tympani Injury and Quality of Life

Conditions
-----------------
Ear Middle Problems

Intervention / Treatment
-----------------
* Other: Questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient undergoing middle ear surgery Acceptation to participate under 18 years old, parental authorization. Exclusion Criteria: Taste disturbance before surgery Patients with guardianship or tutelage measure
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Middle ear surgery<br> | Other: Questionnaire<br>* Questionnaire about taste and salivary disturbance before surgery, 10 days, 4 months and 1 year after surgery. Questionnaires include characteristics of taste disturbance, and specific impact on quality of life.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency, duration and characteristics of taste and salivary disturbance after middle ear surgery and impact on quality of life. | Taste and salivary disturbance will be measure with questionnaire before and during 1 year after middle ear surgery | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Influence of CTN injury type: stretch versus sectionned, influence of otologic desease | Measure with surgeon questionnaire | 1 day | 
| Influence of use between endoscope or microscope surgery | Measure with surgeon questionnaire | 1 day |
Fecal Biomarker Study for Patients With Ulcerative Colitis

Study Overview
=================
Brief Summary
-----------------
The present study will analyze fecal levels of FC and FL in UC patients who relapse (flare) while on a QD or a BID Asacol treatment regimen and compare those levels to levels of FC and FL in UC patients who do not relapse (flare).

Official Title
-----------------
Fecal Biomarker Study for Patients From a Once Daily Study for Efficacy in a Ulcerative Colitis Maintenance Study

Conditions
-----------------
Ulcerative Colitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be willing and able to provide written informed consent for this biomarker study; Be enrolled in Study 2007021 (QDIEM). Exclusion Criteria: Meet the QDIEM Protocol 2007021 for Exclusion Criteria

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 |
| --- | --- |
| 1<br>Patients are in a state of remission | |
| 2<br>Patients are in a flare | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the fecal biomarker calprotectin between the UC patients who relapse (flare) and the UC patients who remain in remission throughout the study while on Asacol regardless of the maintenance regimen. |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the fecal levels of the 2 biomarkers (FC and FL) in patients who are on BID and QD treatment regimens and who remain in remission for the duration of the study; |  | one year |
Rehabilitation Program for the Sequelae of COVID 19 Infection

Study Overview
=================
Brief Summary
-----------------
SUBPROJECT 1: Describe the situation of post-Covid patients in terms of muscle (skeletal and respiratory), cognitive, emotional and health-related quality of life in the 1st visit of the multidisciplinary post-covid rehabilitation consultation at the Hospital. Retrospective observational study. The data collected in clinical records during the first visit in the post-covid Rehabilitation consultation will be analysed. SUBPROJECT 2: Evaluate the response to a personalized rehabilitation program in patients with post-covid sequelae in terms of muscle (skeletal and respiratory), and health-related quality of life. Prospective observational study of a single cohort of patients. The data will be collected from successive clinical visits.

Official Title
-----------------
Evaluate a Rehabilitation Program for the Sequelae of COVID 19 Infection: Description of a Clinical Practice

Conditions
-----------------
Covid19

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Patients who were diagnosed with Covid-19 pneumonia, confirmed by serological tests or molecular biology test (PCR), and who were at home at the time of the 1st visit. PCR or serological negative test or more than 28 days after diagnosis. Dyspnoea in activities of daily living (mMRC ≥ 2), (Annex 5 of the clinical protocol). Patients who had muscle weakness (Clinical Frailty Scale ≥ 3), (Annex 1 of the clinical protocol). Exclusion Criteria: Patients with disease activity. Live outside the reference area of the Hospital de la Santa Creu i Sant Pau. Patients with cognitive impairment that makes it difficult to carry out the rehabilitation program.

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscular function | Short Physical Performance Battery (SPPB) value 0-12 | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health-related Quality of life | SF36 questionnaire, vaule 0-100 | 1 year | 
| Respiratory muscle function | Maximal inspiratory pressure (MIP) Maximal expiratory pressure (MEP) | 1 year | 
| Exercise capacity | Six-minute walking Test (6MWT): meters, | 1 year |
Observational Study Evaluating Rituximab Use and Use of the Patient Alert Card in Participants Receiving Rituximab Infusion for a Non-Oncology Indication at Infusion Centers in Europe

Study Overview
=================
Brief Summary
-----------------
This study is to characterize the indications for which rituximab is being used and to evaluate the use of the Patient Alert Card (PAC) in participants receiving the medication for non-oncology conditions at infusion centers. The study involves the retrospective chart review of rituximab users' medical records in non-oncology indications as well as a survey to collect information on participant characteristics, and will include questions about participant knowledge on the risk of infections, participant receipt and review of the PAC, and any actions the participant has taken as a result of receiving the PAC.

Official Title
-----------------
MabThera Drug Utilisation Study and Patient Alert Card Evaluation in Non-Oncology Patients in Europe: An Infusion Centre-Based Approach

Conditions
-----------------
Off-Label Use

Intervention / Treatment
-----------------
* Biological: Rituximab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participant is in the center to receive an infusion for rituximab for a non-oncology indication during the study period Aged 18 years or older Exclusion Criteria: Has previously already completed the rituximab survey Has participated in the past 12 months in a clinical trial in which rituximab was one of the treatments being evaluated.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort<br>Cohort consisting of participants who are in the center to receive an infusion for rituximab for a non-oncology indication. | Biological: Rituximab<br>* Rituximab use in non-oncology indications<br>* Other names: MabThera;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Aware of Known and Potential Risks of Infection Associated with Rituximab |  | Up to 10 months | 
| Percentage of Participants Using Rituximab Off-Label |  | Up to 10 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Activity Score Based on 28 Joints (DAS28) for Participants with Rheumatoid Arthritis (RA) |  | Up to 10 months | 
| Percentage of Participants Who Received the Patient Alert Card (PAC) |  | Up to 10 months | 
| Percentage of Participants Who Read the PAC |  | Up to 10 months | 
| Percentage of Participants Who Received Additional Safety-Related Materials |  | Up to 10 months |
PIMS-TS in Intensive Care: Retrospective Cohort Trial

Study Overview
=================
Brief Summary
-----------------
Pediatric Multisystem Inflammatory Syndrome Temporally associated with SARS-CoV-2, (PMIS-TS) represents the new unit, partially imitating the previously described Kawasaki disease. Due to variable and frequently incomplete clinical presentation together with variable disease severity, the real incidence in pediatric population remains unclear. Currently, PIMS-TS is defined by persistent fever, elevation of inflammatory markers, organ dysfunction (cardiac, central nervous system, respiratory, coagulation, renal, gastrointestinal), skin lesions (exanthematous), and absence of other possible etiology.

Detailed Description
-----------------
During the world COVID-19 pandemic (2020-2022), pediatric patients with PIMS-TS represented a significant part of pediatric intensive care unit (PICU) load. The initial clinical presentation of patients with PIMS-TS could vary significantly, and also due to progressively evolving recommendations, the diagnostic a therapy could vary regionally and over the time too. The aim of this retrospective cohort trial was to describe the initial clinical presentation, diagnostics, therapy and clinical outcome of pediatric patients admitted during 2020-2022 to the one of the 3 university hospital PICUs.

Official Title
-----------------
Pediatric Inflammatory Multisystem Syndrome (PIMS-TS) in Pediatric Intensive Care: Retrospective Cohort Trial

Conditions
-----------------
Pims-Ts

Intervention / Treatment
-----------------
* Other: PIMS-TS diagnostic a treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pediatric patients with PIMS-TS PICU admission Exclusion Criteria: insufficient data patients not admitted to PICU

Ages Eligible for Study
-----------------
Maximum Age: 19 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PIMS-TS patients<br>Pediatric patients with PIMS-TS admitted to the PICU in selected time period | Other: PIMS-TS diagnostic a treatment<br>* PIMS-TS diagnostic a treatment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Initial clinical presentation | Vital signs | During the first 24 hours after PICU admission | 
| Initial laboratory results |  | During the first 24 hours after PICU admission | 
| PIMS-TS treatment | PIMS-TS treatment specification | During the first month after PICU admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PIMS-TS outcome | clinical and cardiology outcome after 1 month | after one month from hospital discharge | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PIMS-TS, children, child, intensive care, critical illness
One Hour Preoperative Gatifloxacin

Study Overview
=================
Brief Summary
-----------------
Comparison of 1 day versus 1 hour application of topical Zymar.

Official Title
-----------------
One Hour Preoperative Gatifloxacin

Conditions
-----------------
Ophthalmic Surgery

Intervention / Treatment
-----------------
* Drug: Zymar


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ophthalmic surgery Exclusion Criteria: taken antibiotics, allergic to fluoroquinolones

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: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1 hour gatifloxacin<br>presence of conjunctival bacteria 1 hour after administration of topical gatifloxacin | Drug: Zymar<br>* zymar qid<br>* Other names: gatifloxacin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participant With Positive Culture |  | 2 weeks |