linjc16/ctgov huggingface dataset:
Effects of Red Light LED Therapy on Body Contouring

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether red light therapy using LED 650nm red light for body contouring of the waist, hips and thighs is as effective as red light therapy using Laser 635nm red light.

Detailed Description
-----------------
Red light laser therapy using 635nm red light laser technology has previously been shown to cause lipolysis in subcutaneous fat as a non-surgical method to promote weight loss and body contouring. This study hypothesizes that red LED light therapy using 650nm red light LED (light emitting diode) technology produces similar results to the laser device (red LASER 635nm) when preformed using a specified treatment protocol. Furthermore, it is hypothesized that the Vevazz therapy program achieves the results after a single 28 minute treatment. The predicate 635nm LED device (Photonica Professional by Ward Photonics) achieves its results after one 32 minute therapy program. The Vevazz therapy program uses the Vevazz LED device for fat removal using LED red light therapy. This multi-site study reviews results from 66 randomly selected patients after a single treatment using the Vevazz LED device.

Official Title
-----------------
A Retrospective Analysis of the Effects of Red Light LED Therapy on Body Contouring

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Device: Vevazz LED


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 18 years or older. May be male or female. Generally good health. Exclusion Criteria: Minors. Open wounds or sores. Pacemaker. Photosensitivity. Epilepsy. Any form of cancer. Severe kidney or liver problems. Thyroid problems. Pregnant or nursing.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 77 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active Device<br>Active Device: Vevazz LED red light therapy system Vevazz LED red light therapy system is a treatment regimen using the Vevazz LED device for fat removal using LED red light therapy. | Device: Vevazz LED<br>* Vevazz LED red light therapy is a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist and thighs.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Fat Amount (Reduction) in Treatment Area as Measured in Inches Lost | Circumferential measurement of thighs, hips and waist before and after treatment. | One 28 minute treatment session. |
Historical Case Record Survey of Visual Acuity Data From Patients With Leber's Hereditary Optic Neuropathy (LHON)

Study Overview
=================
Brief Summary
-----------------
The purpose of this survey is to collect visual acuity data from patients with LHON in order to establish the clinical course (natural history) and visual acuity outcomes in patients with a genetically confirmed diagnosis of LHON. In addition, this survey will generate data that will serve as comparator for the open-label study SNT-IV-006.

Official Title
-----------------
Historical Case Record Survey of Visual Acuity Data From Patients With Leber's Hereditary Optic Neuropathy (LHON)

Conditions
-----------------
Leber's Hereditary Optic Neuropathy (LHON)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age ≥ 12 years the onset of symptoms is dated after 1999 and is well documented (at least month of onset of symptoms is known for each eye) at least two VA assessments are available within 5 years of onset of symptoms and prior to idebenone use have a genetic diagnosis for LHON for one of the following mitochondrial DNA (mtDNA) mutations: G11778A, G3460A, T14484C Exclusion Criteria: any participation in an interventional clinical trial after the onset of symptoms any other cause of visual impairment (e.g. glaucoma, diabetic retinopathy, AIDS related visual impairment, cataract, macular degeneration, etc.) or any active ocular disorder (uveitis, infections, inflammatory retinal disease, thyroid eye disease, etc.) during the data collection period

Ages Eligible for Study
-----------------
Minimum Age: 12 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 |
| --- | --- | --- |
| In Eyes With VA Assessment Made ≤1 Year After Onset of Symptoms: Proportion of Eyes With Clinically Relevant Recovery (CRR) of VA (Measured by Change in ETDRS Letters) From Baseline (BL) or in Which BL VA Better Than 1.0 logMAR Was Maintained at 12 Months | Clinically Relevant Recovery (CRR) is defined as a VA improvement from off-chart (ETDRS) to 5 letters on-chart, or an on-chart improvement of 10 letters. | 12 months |
Relapse Prevention for Bipolar Type-II Disorder

Study Overview
=================
Brief Summary
-----------------
This 62-week study will compare the safety and effectiveness of fluoxetine (Prozac®), lithium, the combination of these two medications, and placebo in treating and preventing recurrent depressive episodes in people with bipolar type II disorder.

Detailed Description
-----------------
Bipolar II (BP II) disorder is characterized by a high recurrence of major depressive episodes (MDE), and it is associated with substantial illness and deaths. Unfortunately, relatively little attention has been given to treatment of BP II. Concern that patients may switch from depressed to manic states during treatment of MDE has impeded the development of effective treatments for BP II MDE. BP II MDE patients are treated initially with fluoxetine for 10 weeks. Patients who recover from MDE are then randomized to receive a relapse-prevention treatment of fluoxetine, lithium, a combination of fluoxetine and lithium, or placebo for 1 year. Patients undergo clinical and laboratory evaluations, including physical examinations, bloodwork, thyroid function tests, electrocardiogram (ECG), urinalysis, and HAM-D, YMR, CGI-S, CGI-I, and adverse events scales. For information on a related study, please follow this link: http://clinicaltrials.gov/show/NCT00602537

Official Title
-----------------
Relapse Prevention of Bipolar Type-II Disorder

Conditions
-----------------
Bipolar Disorder, Depression

Intervention / Treatment
-----------------
* Drug: Fluoxetine
* Drug: Lithium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Bipolar II Depression

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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

| Intervention/Treatment |
| --- |
|Drug: Fluoxetine|nan|
|Drug: Lithium|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Brimonidine in Rosacea

Study Overview
=================
Brief Summary
-----------------
Rosacea is a chronic and relapsing inflammatory cutaneous disorder with highly variable prevalence worldwide.

Detailed Description
-----------------
In our study, we will compare the safety, efficacy, and adverse effects of low-dose oral doxycycline alone versus combined with pulsed dye laser or topical brimonidine in treating erythematotelangiectatic rosacea in an attempt to build a treatment strategy in a disease with complex pathogenesis.

Official Title
-----------------
Efficacy and Safety of Combining Doxycycline With Pulsed Dye Laser Versus Topical Brimonidine 0.33% in the Treatment of Erythematotelangiectatic Rosacea: a Comparative Clinical and Dermoscopic Study

Conditions
-----------------
Rosacea

Intervention / Treatment
-----------------
* Other: treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with current erythematotelangiectatic rosacea Exclusion Criteria: - Pregnant females. 2-Patients on systemic steroids. 3-Patients complaining of other dermatological disorders mainly photosensitive cutaneous disorder. 4- Patients receiving any systemic treatment including retinoids for the previous 1 month or any topical treatment for the previous 2 weeks or any laser sessions for the previous 3months for erythematotelangiectatic rosacea at least.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pulsed dye laser<br>Laser | Other: treatment<br>* types<br>|
| Active Comparator: Doxycycline<br>Drug | Other: treatment<br>* types<br>|
| Active Comparator: Brimonidine gel 0.33%<br>Topical drug | Other: treatment<br>* types<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical erythema assessment scale | clinical scale | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thickness of capillaries by dermoscope | Assessment | 3 months |
Sexual Health and Problems During the Covid -19 Infection

Study Overview
=================
Brief Summary
-----------------
Covid-19 is an emerging critical highly infectious virus

Detailed Description
-----------------
The covid-19 pandemic is a very harmful crisis that affects all human activities

Official Title
-----------------
Sexual and Marital Health and Problems During the Covid -19 in the Last Months

Conditions
-----------------
Sexual Behavior

Intervention / Treatment
-----------------
* Behavioral: questionaire to husband and wife


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: any partners between 18-60 years Exclusion Criteria: any husband or wife that have organic sexual problems

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?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: questionaire to husband and wife|a form of questions will be asked to every partner|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the number of partners that have unusual behaviour | the husband and wife who have abnormal behaviour | One month |
Extension to a Study to Assess the Efficacy and Safety of Three Doses of Vildagliptin in Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This is a 28-week extension to a study of the safety and effectiveness of three doses of vildagliptin, an unapproved drug, compared to placebo in lowering overall blood glucose levels in people with type 2 diabetes who have not been previously treated with drug therapy to lower their blood sugar. The purpose of the extension study is to gather long-term safety and efficacy data for vildagliptin in people with type 2 diabetes.

Official Title
-----------------
Extension to a Study to Assess the Efficacy and Safety of Three Doses of Vildagliptin in Patients With Type 2 Diabetes

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: vildagliptin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Only patients successfully completing study CLAF237A2301 are eligible Written informed consent Ability to comply with all study requirements Exclusion Criteria: Premature discontinuation from study CLAF237A2301 Other protocol-defined exclusion criteria may apply

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: vildagliptin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of vildagliptin during 52 weeks of treatment |  |  | 
| Change from baseline in HbA1c at 52 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c between 24 weeks and 52 weeks |  |  | 
| Change from baseline in fasting plasma glucose at 52 weeks |  |  | 
| Change in fasting plasma glucose between 24 weeks and 52 weeks |  |  | 
| Change from baseline in HOMA B at 52 weeks |  |  | 
| Change from baseline in HOMA IR at 52 weeks |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
type 2 diabetes, vildagliptin
Cerebral Desaturation and Postoperative Dysfunction After Thoracic Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study prospective observational study is to determine cognitive dysfunction incidence after thoracic surgery. We also evaluate evaluate the role of cerebral oxygen desaturations and hypertension as risk factors for post-operative cognitive dysfunction (POCD) in patients undergoing lung resection.

Official Title
-----------------
Cerebral Desaturation During One Lung-ventilation and Postoperative Dysfunction Afterthoracic Surgery: a Prospective Observational Study

Conditions
-----------------
Thoracic Surgery, Cognitive Dysfunction

Intervention / Treatment
-----------------
* Diagnostic Test: cerebral desaturation monitoring and cognitive examination


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients scheduled for elective lobectomy or wedge resection via thoracotomy one lung ventilation (OLV duration) ≥ 45 min Exclusion Criteria: previous cerebral disease, dementia, severe cognitive dysfunction emergency surgery pregnancy patient refusal to give consent inability to give consent age ≤18 years ASA ≥ IV.

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: cerebral desaturation monitoring and cognitive examination|Before general anesthesia, continuous monitoring of cerebral oxygenation(rSO2) was started using an INVOS 5100 (Somaneic, Tro, MI) .Patient cognitive function was assessed using Mini-Mental State Examination (MMSE) on the day before surgery (baseline) and then after 1 day after surgery.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of cognitive dysfunction after thoracic surgery | A decrease in Mini-Mental State Examination (MMSE) score > 2 points from baseline was defined as Postoperative cognitive dysfunction (POCD) | change of MMSE score from the day before surgery (baseline) at 1 day after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| role of cerebral oxygen desaturations as risk factors for POCD in patients undergoing lung resection. | monitoring values of cerebral saturation during intraoperative period:Cerebral desaturation was defined as a reduction of rSO2 during OLV of more than 20% from the baseline value | change of cerebral saturation from baseline(before surgery) at intraoperative measure | 
| role of hypertension as risk factors for POCD in patients undergoing lung resection. | monitoring values of blood pressure during intraoperative period | change of blood pressure from baseline(before surgery) at intraoperative measure |
Task-dependent Operation of a Mechanism Intracortical Inhibition in Dystonia

Study Overview
=================
Brief Summary
-----------------
Cortical excitability depends on inhibitory mechanisms efficiency among which long latency intracortical inhibition (LICI) can be studied by paired pulses transcranial magnetic stimulation (TMS). Some recent evidences suggest that LICI may be one of the mechanisms by which the motor comment is adapted to the ongoing motor task with LICI strength being dependent on task complexity. In writer cramp and musician cramp, two forms of dystonia, the cortical excitability is not correctly modulated in some complex gestures. the hypothesis is that this task dependent perturbation of excitability in writer cramp could be due to a lack of LICI efficiency.

Official Title
-----------------
Task-dependent Operation of a Mechanism Intracortical Inhibition in Dystonia

Conditions
-----------------
Dystonia, Primary

Intervention / Treatment
-----------------
* Other: LICI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with hand dystonia : writers cramp Subject affiliated to social security regimen. For healthy volunteers : Healthy volunteer without neurological disorders based on sensorimotor examination. Subject affiliated to social security regimen. Exclusion Criteria : Subject unable to receive informed consent (dementia). Contraindication to Transcranial Magnetic Stimulation(TMS) (epilepsia, intracranial metalic foreign object, hearing device, cochlear implant). Patient using a psychotrope treatment. Patient under guardianship or curatorship. Pregnant or nursing women. Patient with a cardiac stimulator. For healthy volunteers only : • Abnormal neurological evaluation based on sensorimotor examination or neurological history ( epilepsy, stroke ; brain or spinal cord surgery ; history of neurological disease affective sensitive and motor control)

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 10 patient with dystonia and 10 healthy subject paired by sex and age.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy subject<br>LICI | Other: LICI<br>* Paired pulse TMS to measure LICI and late cortical disinhibition<br>|
| Experimental: Dystonic subject<br>LICI | Other: LICI<br>* Paired pulse TMS to measure LICI and late cortical disinhibition<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| long-interval intracortical inhibition (LICI) level | Amount of inhibition at interstimulus intervals of between 50 to 300ms | Baseline |
Study to Assess Safety and Tolerability of AZD2171 After Multiple Doses in Patients With Advanced Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
A study to assess safety and tolerability of AZD2171 after multiple doses in patients with advanced prostate cancer.

Official Title
-----------------
A Phase I Open-label Dose Escalation Study to Assess the Safety and Tolerability of AZD2171 Following Multiple Oral Doses in Subjects With Advanced Prostate Cancer.

Conditions
-----------------
Advanced Prostate Adenocarcinoma

Intervention / Treatment
-----------------
* Drug: AZD2171


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men, 18yrs and older Histological or cytological confirmation of prostate adenocarcinoma (symptomatic or asymptomatic) Prior hormonal therapy, and/or no more than 1 prior chemotherapy regimen (including estramustine and/or corticosteroids) for treatment of prostate adenocarcinoma Exclusion Criteria: Prior radiotherapy to bone metastases within 4 weeks prior to screening any unresolved chronic toxicity greater than CTCAE grade 2 from previous anticancer therapy Brain metastases or spinal cord compression, unless treated at least 4 weeks before entry, and stable with steroid treatment for 1 week.

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: AZD2171|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To establish the safety and tolerability of AZD2171 in subjects with advanced prostate adenocarcinoma |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Explore the PK profile of AZD2171 at steady-state administration to subjects |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Advanced Prostate Cancer