linjc16/ctgov huggingface dataset:
PHP Home Preferential Hyperacuity Perimeter for the Detection of Choroidal Neovascularization (CNV)

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to assess the ability of the PHP & HPHP to detect newly diagnosed non treated Chorodial neovascularization (CNV) lesion associate with advanced age related Macular Degeneration (AMD) and differentiate them from Early/intermediate/GA AMD

Detailed Description
-----------------
the study is prospective, multi-center, comparative The PHP is a class I FDA approved Device ( K050350 )

Official Title
-----------------
PHP Preferential Hyperacuity Perimeter for the Detection of Choroidal Neovascularization (CNV)

Conditions
-----------------
Age Related Macular Degeneration

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with AMD related lesions: Newly diagnosed (up to 6 months) non-treated CNV patients secondary to AMD in the study eye, or GA patients or Early and Intermediate AMD patients. Age ³ 50 for AMD patients VA with habitual correction in study eye 6/60 or better Mental and physical ability to perform a PHP/HPHP test Subject able and willing to sign consent form and participate in study Subject is not participating in another study when conducting the test Exclusion Criteria: Evidence of macular disease other than AMD or Glaucoma in the study eye. Presence of any significant media opacity that precludes a clear view of the macular area as identified by biomicroscopy, fundus photography, or fluorescein angiography in the study eye Any non-macular related ocular surgery performed within 3 months prior to the study in the study eye CNV patient inability to tolerate intravenous fluorescein angiography

Ages Eligible for Study
-----------------
Minimum Age: 50 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>Intermediate AMD | |
| 2<br>New untreated CNV subject | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AMD, CNV, PHP
Post-transplantation Cyclophosphamide for Haploidentical Transplant From Maternal or Collateral Donors

Study Overview
=================
Brief Summary
-----------------
In beijing model for haploidentical transplant, the rate of acute graft-versus-host disease (GVHD) from maternal or collateral donors was significantly higher than that from other kins. To reduce the GVHD incidence from maternal or collateral donors, post-transplantation cyclophosphamide is planned to be added into the protocol in beijing model.

Conditions
-----------------
Hematopoietic Stem Cell Transplantation

Intervention / Treatment
-----------------
* Drug: post-transplantation cyclophosphamide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: haploidentical patients from maternal or collateral donors Exclusion Criteria: uncontrolled infection before transplant
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treatment group<br>post-transplantation cyclophosphamide | Drug: post-transplantation cyclophosphamide<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of acute GVHD |  | participants will be followed for an expected average of 365 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| rate of non-relapse mortality |  | participants will be followed for an expected average of 365 days | 
| rate of relapse |  | participants will be followed for an expected average of 365 days | 
| probability of survival |  | participants will be followed for an expected average of 365 days |
Psychological Distress & Stress in Parents With Preterm infants-a Prospective Study

Study Overview
=================
Brief Summary
-----------------
The purpose of the present prospective study is the analysis of risk and protective factors of perinatal stress and psychological distress of parents with or without a preterm child. Stress is measured biologically by Cortisol levels and psychologically by a questionnaire. Different outcomes of psychological distress (e.g. anxiety, depression, posttraumatic stress disorder, burnout) are measured by various questionnaires. We analyze the influence of different aspects as personality traits, social support, partnership.

Official Title
-----------------
Psychological Distress & Stress in Parents With Preterm infants-a Prospective Study on Risk and Protective Psychobiological Aspects

Conditions
-----------------
Preterm Birth, Pregnancy, Stress, Psychological Distress

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnant women and their partners from the 24th week of gestation on 18 years of age Exclusion Criteria: psychiatric, mainly psychotic diseases drug abuse severe neurological disorders stillbirth

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Preterm birth/ Timely birth<br> | |
| Women/men<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| stress |  | two years |
Evaluation of the Effectiveness and Safety of the Ulthera™ System for the Treatment of Wrinkles Around the Eyes

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to look at how safe and effective the Ulthera ultrasound system is at reducing the appearance of wrinkles when used with subjects who have wrinkles around the eyes.

Detailed Description
-----------------
The purpose of this prospective, multi-center, single treatment, clinical trial is to evaluate the effectiveness and safety of the Ulthera™ System for the non-invasive treatment of periorbital wrinkles and rhytids.

Official Title
-----------------
Evaluation of the Effectiveness and Safety of the Ulthera™ System for the Treatment of Periorbital Wrinkles

Conditions
-----------------
Periorbital Wrinkles

Intervention / Treatment
-----------------
* Device: Ulthera™ System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female, aged 40 to 70 years Subject in good health Desire improvement in periorbital wrinkles Subject provides informed consent and agrees to attend follow-up visits Subject signs a HIPPA authorization Exclusion Criteria: Pregnant or lactating Has an active systemic or local skin disease that may alter wound healing Has significant scarring in test areas Has significant open facial wounds or lesions Has severe or cystic acne on the face Has a metal stent or implant in the face area Is a current smoker or has a history of smoking in last 10 years

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: I<br> | Device: Ulthera™ System<br>* ultrasound treatment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reduction of periorbital wrinkles |  | 3 and 6 months |
Treatment of Patients With Newly Onset of Type 1 Diabetes With Mesenchymal Stem Cells

Study Overview
=================
Brief Summary
-----------------
The main hypothesis of the investigators study is that the development of autoimmune diabetes may be halted att diagnosis by the immune modulatory properties of mesenchymal stem cells.

Official Title
-----------------
Open Study to Evaluate the Safety and Efficacy of Autologous Mesenchymal Stem Cells in Treatment of Recently Diagnosed Patients With Type 1 Diabetes Mellitus

Conditions
-----------------
Type 1 Diabetes

Intervention / Treatment
-----------------
* Biological: Mesenchymal stem cells


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ability to provide written informed consent Mentally stable and able to comply with the procedures of the study protocol Clinical history compatible with type 1 diabetes diagnosed less than 10 days of enrolment Stimulate c-peptide >0.1 nmol/l Exclusion Criteria: Patients with BMI>30 Patients with unstable cardiovascular status Patients with active infections, unless treatment is not judged necessary by the investigators Patients with serological evidence of infection with HIV, hepatitis B or hepatitis C. Sexually active females who are not a) postmenopausal, b) surgically sterile or c) using an acceptable method of contraception: oral contraceptives, Norplant, Depo-provera and barrier devices combined with spermicidal gel are acceptable. Patients with known or previous malignancy. Patient with any condition or any circumstance that in the opinion of the investigator would make it unsafe to undergo treatment with autologous MSC.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mesenchymal stem cells<br>Comparison of active treatment with autologous mesenchymal stem cells (in addition to standard treatment) to standard treatment of patients newly diagnosed with type 1 diabetes mellitus. | Biological: Mesenchymal stem cells<br>* Autologous transplantation of the patients own mesenchymal stem cells (approximately 2 x 106 cells/kg body weight) intravenously.<br>|
| No Intervention: Control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The concentration of stimulated c-peptide at 90 minutes after the start of a mixed meal tolerance test at 365+/-10 days following the infusion or not with mesenchymal stem cells |  | 1 year after intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
type 1 diabetes, mesenchymal stem cells, intervention
The Value of Preoperative Dynamic Lymphscintigraphy and Ultrasoundscanning, Eventually With FNA, for Identification of Malignant Sentinel Node(s) in Patients With Melanoma

Study Overview
=================
Brief Summary
-----------------
The goal with this study is to evaluate the value of dynamic lymphscintigraphy and ultrasoundscanning preoperative in patients with melanomas.

Conditions
-----------------
Melanoma

Intervention / Treatment
-----------------
* Procedure: FNA (fine needle aspiration)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically verified melanomas, at least 1 mm thickness, or thinner melanomas with ulceration and/or Clarks level IV-V and/or mitoserate at least 1/mm2. Exclusion Criteria: Other malignant illness Known local, regional or non-regional metastasis on the time of diagnonsis Comorbidity which contraindicate lymphnoderemoval Age less than 18 yrs

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 |
| --- | --- |
| Experimental: ultrasound, dynamic lymphscintigraphy<br> | Procedure: FNA (fine needle aspiration)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
A Study to Investigate Use Patterns and Safety in Simulated Actual Over-the-counter (OTC) Use of Rabeprazole Sodium for the Treatment of Heartburn Symptoms

Study Overview
=================
Brief Summary
-----------------
This is a multi-center, open-label, all-comers OTC actual use study in pharmacy sites where the principal investigator will be a pharmacist.

Official Title
-----------------
A Multi-Center, Open-Label, All-Comers, Single Group Observational Study to Investigate Use Patterns and Safety in Simulated Actual Over-the-counter (OTC )Use of Rabeprazole Sodium for the Treatment of Heartburn Symptoms

Conditions
-----------------
Frequent Heartburn

Intervention / Treatment
-----------------
* Drug: Rabeprazole sodium


Participation Criteria
=================
Eligibility Criteria
-----------------
INCLUSION CRITERIA To be eligible for participation, consumers must: Male or female, 18 years of age or older Select and purchase the study medication for their own use Be able to take part in periodic telephone interviews regarding their use of and experience with the medication Give written informed consent for participation EXCLUSION CRITERIA Consumers will be excluded from participation if they meet any of the following criteria: Allergic to rabeprazole Currently have trouble or pain swallowing food Currently have vomiting with blood Currently have bloody or black stool Currently pregnant or breast-feeding Participated in a study regarding a heartburn medication during the last 12 months

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 |
| --- | --- |
| Experimental 1<br> | Drug: Rabeprazole sodium<br>* Rabeprazole sodium 10 mg orally every day for 14 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of subjects who make an appropriate initial decision about whether to select AcipHex. OTC for their own use |  | screening visit (Day 0 ) | 
| The percentage of subjects who follow key directions for use (1 tablet per day, 14-day course of treatment, and no more than one course of treatment every 4 months) |  | 14 day treatment period; up to 4 months | 
| The percentage of subjects who make appropriate ongoing decisions about suitability for treatment (including consulting a physician and appropriately modifying or discontinuing use based on label directions) |  | 14 day treatment period; up to 4 months | 
| The percentage of subjects who experience serious / non-serious adverse events |  | : 14 day treatment period; up to 4 months |
Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease. Ratio-Study. (BY217/M2-112)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the effect of 500mcg roflumilast vs placebo on exacerbation rate and pulmonary function as well as quality of life in patients with chronic obstructive pulmonary disease (COPD).

Official Title
-----------------
Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease. A 52 Weeks Double Blind Study With 500mcg Roflumilast Once Daily Versus Placebo. Ratio-Study.

Conditions
-----------------
Chronic Obstructive Pulmonary Disease, COPD

Intervention / Treatment
-----------------
* Drug: Roflumilast


Participation Criteria
=================
Eligibility Criteria
-----------------
Main Inclusion Criteria: FEV1/FVC ratio (post-bronchodilator) ≤70% FEV1 (post-bronchodilator) ≤50% of predicted Current smoker or ex-smoker Clinically stable COPD indicated by no exacerbation and no change in COPD treatment of within 4 weeks prior to baseline Availability of a chest x-ray dated a maximum of 6 months prior to study baseline visit B0 or a willingness to have a chest x-ray performed before baseline Main Exclusion Criteria: COPD exacerbation indicated by a treatment with systemic glucocorticoids not stopped 4 weeks prior to baseline Lower respiratory tract infection not resolved 4 weeks prior to baseline Diagnosis of asthma and/or other relevant lung disease Known alpha-1-antitrypsin deficiency Need for long-term oxygen therapy defined as ≥16 hours/day

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Roflumilast|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The frequency of patients experiencing at least one moderate or severe exacerbation during the treatment period. |  |  | 
| Change in FEV1 from baseline during the treatment period. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary function variables; quality of life variables;patient diary variables;safety |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Roflumilast
Description of a Cohort of Covid-19 Patients With a Circulating Anticoagulant

Study Overview
=================
Brief Summary
-----------------
SARS-COV-2 infection is responsible for a potentially severe primarily respiratory infection called COVID19. A large proportion of patients, in particular in severe forms, present with thrombotic manifestations (DVT, EP, stroke, thrombosis of dialysis circuits, etc.). A significant proportion is also a carrier of circulating anticoagulant (ACC or LA), making it possible to suggest a diagnosis of APS. This type of autoantibody results in a spontaneous prolongation of the TCA uncorrected by a control serum therefore is quickly diagnosed using standard hemostasis The objective of this study is to describe the diagnosis of thrombotic complications in COVID19 patients presenting a positive lupus anticoagulant type test (LA) or aPL and the associated clinical and biological elements that may have favored thrombosis.

Official Title
-----------------
Description of a Cohort of Covid-19 Patients With a Circulating Anticoagulant

Conditions
-----------------
SARS-COV-2

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Adult patient (≥18 years old) Patient taken care of in the SMO pole or the NHC surgical resuscitation service or hospitalized or consultant to the HUS between 01/03/2020 and 31/05/2020 Patient infected with Covid-19, with a documented infection, having presented a documented thrombosis (arterial or venous), with an LA or aPL in the thrombosis assessment or Patient infected with Covid-19, with a documented infection, without documented thrombosis (arterial or venous), with in the standard work-up an increase in TCA revealing the presence of LA Subject having given his agreement for the reuse of his data for the purposes of this research Exclusion criteria: Subject having expressed opposition to participating in the study Subject under guardianship or guardianship Subject under safeguard of justice

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Retrospective study of thrombotic complications in a cohort of COVID patients with a circulating anticoagulant |  | Files analysed retrospectively from March 01, 2020 to May 31, 2019 will be examined] | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SARS-COV-2, Covid-19, Antiphospholipid syndrome (APS), autoimmune disease, antiphospholipid antibodies (aPL), thrombosis
Effect of Etoricoxib to Treat Chronic Low Back Pain (0663-042)

Study Overview
=================
Brief Summary
-----------------
Study the effect of etoricoxib 60 mg and 90 mg compared to placebo to treat chronic low back pain.

Official Title
-----------------
A Double-Blind, Placebo-Controlled, Parallel-Group, 12-Week Trial to Assess the Efficacy and Safety of MK0663 in Patients With Chronic Low Back Pain

Conditions
-----------------
Recurrent Low Back Pain

Intervention / Treatment
-----------------
* Drug: MK0663, Etoricoxib / Duration of Treatment : 12 Weeks
* Drug: Comparator : placebo (unspecified) /Duration of Treatment : 12 Weeks


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Low back pain for previous 3 months and majority of days in last month Regular use of acetaminophen or NSAID to treat low back pain in past month Judged to be in otherwise good health Exclusion Criteria: Low back pain that is due to secondary causes Radicular/myelopathic pain Surgery for low back pain within the past 6 months Active lawsuit or claim pertaining to their low back pain Disease that may confound the results of the study or pose risk to the patients Corticosteroid use in past month Previous participation in an MK0663 study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: MK0663, Etoricoxib / Duration of Treatment : 12 Weeks|nan|
|Drug: Comparator : placebo (unspecified) /Duration of Treatment : 12 Weeks|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Low back pain intensity scale (0-100 mm VAS) over 4 weeks compared to placebo |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Low back pain intensity scale (0-100 mm VAS) over 12 weeks compared to placebo |  |  |