linjc16/ctgov huggingface dataset:
Treatment of Social Phobia and Panic Disorder in Adults

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare a stepped care model for the treatment of social phobia and panic disorder with standard psychological treatment. The stepped care model comprises three steps: short psycho-education, a 10 weeks Internet-based self-help program, 12 weeks individual cognitive-behavioural therapy. Patients are assessed at each step and taken out of the study if they show significant clinical improvement and follow for 12 months. Patients are randomized to either the stepped care model or standard psychological treatment, i.e. individual cognitive-behavioural therapy. All treatment components are manualized.

Official Title
-----------------
A Randomized, Controlled Study of a Stepped-care Model for the Treatment of Social Phobia and Panic Disorder in Adults

Conditions
-----------------
Social Phobia, Panic Disorder

Intervention / Treatment
-----------------
* Behavioral: individual cognitive-behavioural therapy
* Behavioral: stepped care model


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnoses of panic disorder or social phobia Informed consent Exclusion Criteria: Alcohol/drug dependency Major depressive disorder Psychosis Unstable medication

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Behavioral: individual cognitive-behavioural therapy<br>* 1 session per week for 12 weeks<br>|
| Active Comparator: 2<br> | Behavioral: stepped care model<br>* three steps: short psycho-education, a 10 weeks Internet-based self-help program, 12 weeks individual cognitive-behavioural therapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Severity Ratings |  | End of treatment and 12 months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questionnaires: The Panic Attack Scale The Body Sensations Questionnaire The Agoraphobic Cognitions Questionnaire The Mobility Inventory for Agoraphobia Social Phobia Scale The Social Interaction Anxiety Scale |  | End of treatment and 12 months follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cognitive therapy, Stepped care, Self-help, Internet, Anxiety
Effect of Intravitreal Bevacizumab on Clinically Significant Macular Edema

Study Overview
=================
Brief Summary
-----------------
to compare the effect of intravitreal bevacizumab alone or in combination with triamcinolone acetonide with laser photocoagulation on clinically significant macular edema (CSME)

Detailed Description
-----------------
we entered 150 eyes into the study that recruitment of cases finished recently.Eligible eyes randomly assign to one of the study arms including intravitreal bevacizumzb, intravitreal bevacizumzb/triamcinolone and macular photocoagulation groups. Every patient needs at least 1 year followup. During this time BCVA, OCT, FA will be done for each patient and inaccording to interpretation of datas and fundus exam repeatation of injection will be done.

Conditions
-----------------
Diabetic Macular Edema

Intervention / Treatment
-----------------
* Drug: bevacizumab
* Drug: triamcinolone acetonide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: case with clear media IOP below 23 mm/Hg female after menopause at least for 12 months or had 2 contraceptive roots visual acuity between 20/50 to 20/320 Exclusion Criteria: no PRP or N.d YAG laser in past 6 months no intraocular surgery in past 12 months CVA in past 12 months blood sugar above 250 active infection in extraocular adnexa
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

| Intervention/Treatment |
| --- |
|Drug: bevacizumab|nan|
|Drug: triamcinolone acetonide|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual acuity |  |  | 
| central macular thickness |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Leakage in fluorescein angiography |  |  | 
| intraocular pressure |  |  | 
| cataract progression |  |  | 
| anterior chamber reaction |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bevacizumab, CSME, MPC, Triamcinolone acetonide
Sun Protection Factor Assay (SPF Assay 203/2016)

Study Overview
=================
Brief Summary
-----------------
To evaluate the Sun Protection Factor efficacy on human skin.

Official Title
-----------------
Sun Protection Factor (SPF) Assay: UVA Protection Factor Assay Minimal Persistent Pigment-Darkening Dose

Conditions
-----------------
Sunscreening Agents

Intervention / Treatment
-----------------
* Drug: BAY987516


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing. Male and female. Aged between 18-70 years old. Good health as determined from the HRL SHF (Subject History Form). Signed and dated Informed Consent Form. Signed and dated HIPAA (Health Insurance Portability and Accountability Act) form. An unambiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose). Exclusion Criteria: Subjects on test at any other research laboratory or clinic. Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light. Pre-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study. Pre-existing other medical conditions (e.g. adult asthma, diabetes). Treatment with antihistamines or corticosteroids within one week prior to initiation of the test. Treatment with antibiotics within two weeks prior to initiation of the test. Chronic medication which could affect the results of the study. Known pregnant or nursing women.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BAY987516<br>Each test site area is divided into test sub site areas that are approximately at least 0.5 cm*2. The application of test material is 2 mg/cm*2. Thus, each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. | Drug: BAY987516<br>* Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. (Formulation Code:Z46-116)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minimal Erythema Dose (MED) |  | Up to 15 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minimal Persistent Pigment Darkening Dose (MPPD) |  | Up to 15 minutes |
Darwishscope Versus Flow Test and Bubble Flow Test in Infertility

Study Overview
=================
Brief Summary
-----------------
Fallopian tube (FT) function is complex. One of the main functions is transport of sperms for fertilization and transport of the embry for implantation. Hysteroscopic access to Darwish Hysteroscopic Triad allows excellent way to assess FT patency. This study compares three ways of assessing FT patency separably or in combination: flow test, bubble flow test and peristalsis test. Combined bubble flow test and peristalsis test is recently published and coined (Darwishscope)1.

Detailed Description
-----------------
This study includes infertile women subjected to combined hysteroscopy and laparoscopy UGA. During hysteroscopy, on each side, three patency test are done successively: flow test, bubble flow test and peristalsis test. Gold standard diagnosis of tubal patency and status is concomitant laparoscopy.

Official Title
-----------------
Darwishscope Versus Flow Test and Bubble Flow Test in Infertility

Conditions
-----------------
Tubal Patency

Intervention / Treatment
-----------------
* Diagnostic Test: Patency test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: infertile women Probably patent FT as proved by a previous hysterosalpingography or laparoscopy. Office setting. Postmenstrual Non use of hormones or hormonal contraceptives. Exclusion Criteria: Premenstrual period. Pathologic FT.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Infertilite women<br>Subjected to three successive hysteroscopic tests | Diagnostic Test: Patency test<br>* Successive flow test, bubble flow test and peristalsis test<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FT patency | Success of the diagnostic test to assess FT patency. | 6 months | 
| Specificity | Effect of combination of more one test to assess tubal patency. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hysteroscopy, bubble flow test, Flow test, Peristalsis, Darwishscope
Swiss Sarcoma Network: Prediction Model for Patient Selection in Sarcoma Care

Study Overview
=================
Brief Summary
-----------------
The primary significance of this project is to perform a detailed analysis to assess the diagnostics, treatment and follow-up care, to develop a prediction model for future patient selection regarding various diagnostic and treatment procedures.

Detailed Description
-----------------
Within the framework of interdisciplinary cooperation for a sarcoma problem, predictive and prognostic criteria will be developed that improve the treatment and particularly outcome. The outcome variables include patient characteristics, tumor types and characteristics, histology, management and treatment strategies as well as recurrence rate and overall survival.

Official Title
-----------------
Swiss Sarcoma Network: Prediction Model for Patient Selection in Sarcoma Care

Conditions
-----------------
Sarcoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Malignant and intermediate and selected benign bone or soft tissue tumors, acc. to the WHO coding list of the SSN Female and male subjects of all ages Exclusion Criteria: Documented objection of subsequent use of personal health data
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 |
| --- | --- | --- |
| Diagnosis, | Data collected in the registry will be evaluated and analyzed to determine criteria to improve treatment strategies | 5 years | 
| Local recurrence, | s.o. | 5 years | 
| distant metastasis, | s.o. | 5 years | 
| biopsy taken by operating surgeon-radiologist-team, | s.o. | 5 years | 
| pathology centrally reviewed, | s.o. | 5 years | 
| Surgery (yes/no), | s.o. | 5 years | 
| Surgical margin status, | s.o. | 5 years | 
| surgery performed by dedicated surgeon, | s.o. | 5 years | 
| Radiation Therapy (yes/no), | s.o. | 5 years | 
| Chemotherapy (yes/no), | s.o. | 5 years | 
| decision of board carried out, | s.o. | 5 years | 
| Status at last contact, | s.o. | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sarcoma, Epithelioid, Sarcoma, Soft Tissue, Sarcoma, Spindle Cell, Sarcoma, Bone
Cytomegalovirus Hyperimmune Globulin (CMV-Ig) Replacement in Hypogammaglobulinemic Lung Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
This is a randomized controlled trial of CMV-Ig in lung transplant recipients at the Cleveland Clinic Foundation who are hypogammaglobulinemic.

Detailed Description
-----------------
This is a randomized controlled trial of CMV-Ig in lung transplant recipients at the Cleveland Clinic Foundation who are hypogammaglobulinemic.

Official Title
-----------------
Does Replacement With CMVIG in Hypogammaglobulinemic Patients Decrease the Rate of Opportunistic Infections and Chronic Rejection?

Conditions
-----------------
Hypogammaglobulinemia

Intervention / Treatment
-----------------
* Drug: CMV-Ig


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Lung transplant Hypogammaglobulinemia
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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: CMV-Ig|Drug: CMV-Ig|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CMV infection |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lung transplantation
Evaluation of the Discontinuation of Maintenance Corticosteroid Treatment in Quiescent Systemic Lupus

Study Overview
=================
Brief Summary
-----------------
Systemic Lupus (SLE) is a chronic disease for which long term treatments are warranted. The aim of this study was to study the possibility of corticosteroids interruption in patients with quiescent SLE treated since at least one year with 5 milligrams of predonisone per day.

Official Title
-----------------
Evaluation of the Discontinuation of Maintenance Corticosteroid Treatment (Prednisone 5 Milligram Per Day) in Quiescent Systemic Lupus

Conditions
-----------------
Systemic Lupus Erythematosus

Intervention / Treatment
-----------------
* Drug: prednisone discontinuation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with SLE according to the ACR revised criteria. Quiescent disease without flare since at least one year (SELENA SLEDAI < or equal to 4, BILAG C, D or E, PGA 0) _ Treatment with 5 milligrams/day of prednisone since at least 1 year Exclusion Criteria: failure to sign the informed consent or unable to consent Patient participating to another clinical trial Pregnancy or plan to become pregnant

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Prednisone maintenance<br>Patients will be kept under Prednisone 5 milligrams/day. Other treatments will be maintained (in particular HYDROXYCHLOROQUINE, METHOTEXATE etc..) | |
| Experimental: Prednisone discontinuation<br>Prednisone will be stopped and remplaced by HYDROCORTISONE for one month (20 mg/day). Other treatments will be maintained (in particular HYDROXYCHLOROQUINE, METHOTEXATE etc..) | Drug: prednisone discontinuation<br>* randomization<br>* Other names: prednisone maintenance;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurence of mild or moderate flares of SLE defined by the SLE FLARE Index |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Systemic Lupus Erythematosus, Corticosteroids, Chronic disease
Efficacy of Two Prophylactic Schedules (Prulifloxacin Versus Phosphomycin)

Study Overview
=================
Brief Summary
-----------------
Epidemiological studies showed that 20-30% of patients with uncomplicated urinary tract infections risked recurrent infection. Urinary tract infection causes marked discomfort for the patient, has a negative impact upon quality of life, and is associated with high social and health costs in terms of specialist appointments, laboratory and instrumental tests and prescriptions . Although diverse cycles of antibiotic therapy and prophylaxis have been proposed, doubts persist about the most efficacious pharmacological agents, duration of prophylaxis , the incidence of adverse effects and relapse when antibiotic therapy is suspended. Aims of the study: To compare the efficacy of two prophylactic schedules (Prulifloxacin vs Phosphomycin): in reducing the number of urinary tract infection episodes during prophylaxis in reducing the number of urinary tract infection episodes after prophylaxis in improving the patient's quality of life . To assess : Tolerability of antibiotic prophylaxis The incidence of resistance to antibiotic therapy

Official Title
-----------------
Efficacy of Prulifloxacin vs Phosphomycin in the Prophylasy of Urinary Tract Infection

Conditions
-----------------
Urinary Tract Infection

Intervention / Treatment
-----------------
* Drug: prulifloxacin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female patients Age over 18 years old No allergies to the drugs to be prescribed No counter-indications to this drug therapy Urine culture shows responsiveness to drugs at recruitment of patient History of urinary tract infections with at least three episodes in the previous year or two in the past six months Exclusion Criteria: Lack of tolerability of prescribed drugs

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
Female

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Prulifloxacin<br> | Drug: prulifloxacin<br>* Prulifloxacin 1 tablet/week for 12 weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of urinary tract infection episodes during prophylaxis |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improving the patient's quality of life |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prophylasy, recurrent urinary tract infection, prulifloxacin, phosphomycin
Safety and Efficacy of Dalbavancin Versus Vancomycin in the Treatment of Catheter-Related Bloodstream Infections

Study Overview
=================
Brief Summary
-----------------
This is a study to evaluate a new medication dosed once a week in the treatment of bacterial infections in the blood from intravenous catheters (CR-BSI). The primary objective is to evaluate the efficacy and safety of dalbavancin in the treatment of adults with CR-BSI relative to a standard of care treatment, vancomycin.

Official Title
-----------------
Phase II, Randomized, Open-Label, Multi-Center Study to Evaluate the Safety and Efficacy of Dalbavancin Versus Vancomycin in the Treatment of Catheter-Related Bloodstream Infections With Suspected or Confirmed Gram-Positive Bacterial Pathogens

Conditions
-----------------
Bacteremia

Intervention / Treatment
-----------------
* Drug: dalbavancin


Participation Criteria
=================
Eligibility Criteria
-----------------
The patient or his/her legally authorized representative has given informed consent by means approved by the investigator's IRB/EC; > 18 years of age; Had one or more central venous catheters at the time initial signs of infection were evident; Creatinine clearance <50 mL/min; Bilirubin > 2x the upper limit of normal; Treatment with an antibiotic effective against Gram-positive bacterial infections for more than 24 hours within 48 hours of study medication initiation, Prolonged antibiotic therapy for CR-BSI anticipated (i.e., >2 weeks)

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: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

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

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