linjc16/ctgov huggingface dataset:
Study to Evaluate the Safety and Efficacy of Androxal Treatment in Men With Secondary Hypogonadism

Study Overview
=================
Brief Summary
-----------------
Subjects who completed ZA-003 were eligible to receive an additional year of treatment in this extension study.

Detailed Description
-----------------
The objectives of this study were to evaluate the safety and efficacy of Androxal® administered orally once daily for one year in men with secondary hypogonadism and who had completed ZA-003.

Official Title
-----------------
An Open-Label, Multiple Center Study to Evaluate the Safety and Efficacy of Androxal™ Treatment in Men With Secondary Hypogonadism Who Completed ZA-003

Conditions
-----------------
Secondary Hypogonadism

Intervention / Treatment
-----------------
* Drug: Androxal
* Drug: Androxal


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Total serum testosterone concentrations < 300 ng/dL at baseline Exclusion Criteria: Presence or history of prostate cancer Elevated PSA > 3.5 ng/mL Additional inclusion and exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 68 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 12.5 mg Androxal<br>12.5 mg Androxal daily | Drug: Androxal<br>* 12.5 mg once daily<br>* Other names: Enclomiphene citrate;|
| Experimental: 25 mg Androxal<br>25 mg Androxal daily | Drug: Androxal<br>* 25 mg once daily<br>* Other names: Enclomiphene citrate;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the safety of Androxal™ administered in men with secondary hypogonadism |  | One year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Secondary Hypogonadism
The Efficacy Of The Wavelight Mydon Laser for Hair Removal And Treatment of Leg Veins

Study Overview
=================
Brief Summary
-----------------
This study is being done to compare the efficacy of an FDA cleared laser device with other similar systems in the market for the treatment of leg veins and hair removal in patients with darker skin type.

Detailed Description
-----------------
The specific aim of the study is to determine the efficacy of this FDA approved laser for hair removal and treatment of leg veins in female patients having darker skin types (Fitzpatrick Skin type III-VI) and compare it with the efficacy of other similar commercial units available in the U.S.

Official Title
-----------------
Determine The Efficacy Of The Wavelight Mydon Laser For Hair Removal And Treatment of Leg Veins

Conditions
-----------------
Leg Veins, Hair Removal

Intervention / Treatment
-----------------
* Device: Laser Treatment
* Device: Wave Light laser device for skin treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female patients of Asian and darker skin type greater than or equal to 18 years of age. Ability to give informed consent. Exclusion Criteria: Pregnancy. Taking medications that are photosensitizing. History of skin disease in the area to be treated over the last 6 months. Ongoing cutaneous lupus erythematosus, morphea, alopecia areata, or severe folliculitis. History of keloidal or hypertrophic scarring. Have inadequate hair growth in the test area of axilla. Have unrealistic expectations of the treatment. Co-existing severe emotional, medical or surgical illness leading to the inability to meet the follow-up requirements.

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Device<br> | Device: Laser Treatment<br>* The laser treatment involves the use of an FDA approved laser device (510K Clearance certificate) for hair removal and treatment of leg veins for females having skin types III - VI. The pulses are of appropriate energy and pulse duration based on the skin type.<br>Device: Wave Light laser device for skin treatment<br>* To determine efficacy of FDA approved Laser treatment for hair removal and leg veins. The Mydon Wavelight is a Long Pulsed Nd Yag Laser, Class IV 1064 nm 55W<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and efficacy of the treatment will determine the outcome. |  | 6 months |
Study of Travatan and Cosopt in Primary Open-Angle Glaucoma or Ocular Hypertension

Study Overview
=================
Brief Summary
-----------------
To compare the efficacy and safety in patients treated with travoprost versus dorzolamide/timolol maleate combination in patients with open-angle glaucoma or ocular hypertension

Official Title
-----------------
Study of Travatan and Cosopt in Primary Open-Angle Glaucoma or Ocular Hypertension

Conditions
-----------------
Open-angle Glaucoma, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: Travatan
* Drug: Cosopt
* Drug: Placebo (Timolol Vehicle)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with open-angle glaucoma or ocular hypertension Exclusion Criteria: By Age

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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Travatan<br>Travatan: 6 weeks treatment with Travatan (travoprost 40 mg/ml eye drops, solution) once daily at 08:00 and placebo (timolol vehicle) once daily at 20:00 in the affected eye(s) | Drug: Travatan<br>* Travatan: 6 weeks treatment with Travatan (travoprost 40 mg/ml eye drops, solution) once daily at 08:00 and placebo (timolol vehicle) once daily at 20:00 in the affected eye(s)<br>Drug: Placebo (Timolol Vehicle)<br>* Travatan group: 6 weeks treatment with Travatan (travoprost 40 mg/ml eye drops, solution) once daily at 08:00 and placebo (timolol vehicle) once daily at 20:00 in the affected eye(s)<br>|
| Active Comparator: Cosopt<br>treatment period of 6 weeks with Cosopt (dorzolamide 20 mg/ml and timolol maleate 5 mg/ml eye drops, solution) twice daily at 08:00 and 20:00 in the affected eye(s) | Drug: Cosopt<br>* treatment period of 6 weeks with Cosopt (dorzolamide 20 mg/ml and timolol maleate 5 mg/ml eye drops, solution) twice daily at 08:00 and 20:00 in the affected eye(s)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intaocular Pressure (IOP) Mean Change After 6 Weeks of Treatment | IOP measured at week 6 minus IOP measured at baseline | At week 0 and week 6 |
Therapeutic Strategy in Advanced Bronchioloalveolar Carcinoma

Study Overview
=================
Brief Summary
-----------------
To evaluate among patients with untreated advanced ADC-CBA, impact on the disease control rate after 4 months treatment of an early therapeutic permutation with the first month in the absence of stabilization or objective answer.

Official Title
-----------------
Effect of an Early Therapeutic Permutation on the Tumoral Control of Patients Receiving in First Line a Specific Inhibitor of Tyrosin Kinase of EGFR (Erlotinib) or a Taxan-based Chemotherapy for the Treatment of Not Resecable Adenocarcinoma With Bronchiolo-alveolar.

Conditions
-----------------
Adenocarcinoma, Bronchiolo-Alveolar

Intervention / Treatment
-----------------
* Drug: erlotinib
* Drug: paclitaxel + carboplatine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: CBA histologically proven (or cytologically with pneumonic presentation) PS < 3 signed and written informed consent Exclusion Criteria: visible tumoral lesion in bronchial fibroscopy

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: erlotinib<br>* Erlotinib 150 mg/day (until progression)<br>|
| Experimental: 2<br> | Drug: paclitaxel + carboplatine<br>* Paclitaxel 90 mg/m² D1, D8, D15 (D1=D28, until progression) Carboplatine AUC 6 D1 (D1=D28, 6 cycles)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 16-week Disease Control Rate |  | 4-week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adenocarcinoma, Bronchiolo-Alveolar
Pioglitazone in Psoriasis- A Clinical and Molecular Study.

Study Overview
=================
Brief Summary
-----------------
The study will assess the effectiveness of Pioglitazone on cellular and clinical levels in terms of improvement of both skin and systemic manifestations of psoriasis. The investigators assume that pioglitazone (one of thiazolidinediones readily available in Egypt), can regulate keratinocytes' disordered proliferation observed in psoriasis, in addition to improving the insulin resistance in peripheral tissues observed in many psoriatic patients and causing metabolic syndrome. This will allow to give a safer therapy than the available ones for psoriasis and to treat the patient in a more global perspective.

Official Title
-----------------
The CLINICAL And MOLECULAR EFFECTS Of An INSULIN SENSITIZING DRUG: 'PIOGLITAZONE'On PSORIASIS TREATMENT

Conditions
-----------------
Psoriasis

Intervention / Treatment
-----------------
* Drug: actozone A
* Drug: actozone B


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years and less than 65 years. Plaque psoriasis vulgaris ≥ 10% (apart from palmoplantar psoriasis which will be included). Exclusion Criteria: Age less than 18 years and more than 65 years Mild psoriasis less than 10% body surface area Erythrodermic or pustular psoriasis Liver disease, cardiac disease (suspected from history or ECG), or any other major medical disorder detected by history. Pregnant and lactating females.

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: actozone A<br>Pioglitazone 30 mg tablets daily | Drug: actozone A<br>* pioglitazone 30 mg tablet , once daily dose for 10 weeks<br>|
| Placebo Comparator: actozone B<br>placebo | Drug: actozone B<br>* one tablet of vehicle without active ingredient pioglitazone<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment success detected as clinical improvement of skin condition | PASI improvement by at least 50% from baseline before treatment(Psoriasis Area and Severity Index)= PASI-50 | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting serum insulin reduction from baseline before treatment |  | 10 weeks | 
| C-reactive protein titre reduction from baseline value before treatment |  | 10 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
psoriasis, insulin resistance, metabolic syndrome, pioglitazone, randomized control trial
A Predictive Model for Difficult Intubation

Study Overview
=================
Brief Summary
-----------------
Failure in airway management is one of the most common anesthesia-related morbidity and mortality. Each individual airway assessment has limitation to predict difficult intubation.

Detailed Description
-----------------
Objective: To develop a scoring model from multiple airway assessment to predict difficult intubation. Methods: This will be a retrospective analytic study. All airway assessment data from medical records of patients aged more than 18 years old underwent general anesthesia in Srinagarind hospital from January 2012 to December 2014 will be used to develop a new scoring prediction model.

Official Title
-----------------
A New Prognostic Model Developed by Using Multi-predictive Tests for Prediction of Difficult Intubation in Adult Anesthetic Patients

Conditions
-----------------
Difficult Intubation

Intervention / Treatment
-----------------
* Procedure: Endotracheal intubation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients undergoing general anesthesia with endotracheal intubation Exclusion Criteria: Incomplete airway assessment in medical record

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| Patient with difficult intubation<br>Group 1: Patient undergoing endotracheal intubation with difficult intubation Group 2: Patient undergoing endotracheal intubation without difficult intubation | Procedure: Endotracheal intubation<br>* Endotracheal intubation under direct laryngoscopy using McIntosh blade<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difficult intubation | Laryngoscopic view: grade 1-2 = no difficult intubation; grade 3-4 = difficult intubation | 5 minutes |
Dongguan Eye Study of Schoolchildren and Adolescents（DESSA）

Study Overview
=================
Brief Summary
-----------------
This is a study to report the change of ocular biometry of schoolchildren and adolescents as well as its association with birth parameters in China.

Official Title
-----------------
A Study on Ocular Biometry Measurement of Schoolchildren and Adolescents in China

Conditions
-----------------
Child Development

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Schoolchildren and adolescents aged 7 to18 years in Dongguan Parents are willing to sign the informed written consent. Exclusion Criteria: Those without informed written consent or unable to obey the study procedures

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 18 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of ocular fundus parameter in schoolchildren and adolescents | Record the change of retinal thickness during the follow-up periods. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of ocular biometry measurement in schoolchildren and adolescents | Record the change of choroidal thickness during the follow-up periods. | 3 years | 
| Changes of ocular anterior segment in schoolchildren and adolescents | Record the change of corneal thickness during the follow-up periods. | 3 years |
Multicentre Evaluation of Bucco-dental Health in Patients With Schizophrenia in Côte d'Or

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to know the bucco-dental status of patients with schizophrenia in Côte d'Or. Participation in this study will last only as long as it takes to: carry out a bucco-dental examination: evaluation of dental plaque and calculus take a blood sample to assess needs in vitamin C (only for patients included at DIJON CHU and CHS Chartreuse) complete a 30-minute questionnaire: clinical data and answers to questions concerning dental hygiene and eating habits.

Official Title
-----------------
Multicentre Evaluation of Bucco-dental Health in Patients With Schizophrenia in Côte d'Or

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Other: Bucco-dental examination
* Other: Blood sample
* Other: Clinical and social questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have provided consent Patients over 18 years of age Persons with schizophrenia according to the ICD 10 criteria and followed in hospital (complete or day hospital) in one of the hospitals taking part in the study Exclusion Criteria: Adult under guardianship Patient not covered by national health insurance Pregnant or breast-feeding women Patients not stabilized from a psychiatric viewpoint Patients experiencing an acute psychiatric episode Impossibility to understand and /or poor understanding of French

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with schizophrenia<br> | Other: Bucco-dental examination<br> <br> Other: Blood sample<br> <br> Other: Clinical and social questionnaire<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Calculate the DMF index (Decayed, Missing, Filled) |  | Baselines | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Calculate the simplified Oral Health Index (OHI-S) |  | Baselines | 
| Perception of oral health of patients observed |  | Baselines |
Safety Dermatological Evaluation: Acceptability With Gynecological Follow up - Dermacyd Tina Gel Sweet Flower

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate the safety of the gynecological formulation in normal and usual usage condition of Dermacyd Tina Gel Sweet Flower.

Official Title
-----------------
Monocentric Study, Phase III, for Safety Dermatological Evaluation: Acceptability With Gynecological Follow up - Dermacyd Tina Gel Tangerina Mix

Conditions
-----------------
Hygiene

Intervention / Treatment
-----------------
* Drug: Lactic acid (Dermacid)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Integral skin test in the region; Exclusion Criteria: Lactation or gestational risk or gestation; Use of Anti-inflammatory or immunosuppression drugs 1 month before the study; Topical medication use at the region to be treated; Cutaneous disease or active gynecological disease which may interfere in study results; Personal history of allergic disease at the area to be treated; Allergic or atopic history; The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 20 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Lactic acid in small quantity during 21 days | Drug: Lactic acid (Dermacid)<br>* Liquid soup to be applied in the external genital area, in a small quantity, with abundantly rinse after use, during 21 days.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events and their intensity and their association with the treatment |  | 21 days |