linjc16/ctgov huggingface dataset:
Controlled Study of MK-0431/ONO-5435 in Patients With Type 2 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety and efficacy of MK-0431/ONO-5435 in patients with Type 2 diabetes mellitus who have inadequate glycemic control on diet/exercise therapy and glimepiride as monotherapy

Official Title
-----------------
MK-0431/ONO-5435 Phase III Clinical Study - Glimepiride add-on Study for Patients With Type 2 Diabetes Mellitus

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

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: Sitagliptin phosphate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with Type 2 diabetes mellitus on diet/exercise therapy and glimepiride as monotherapy Exclusion Criteria: Patients with Type 1 diabetes mellitus

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: P<br> | Drug: Placebo<br>* Double-blind period (12 wk); placebo QD The double-blind period will be followed by a 40 wk open-label extension period where MK-0431/ONO-5435 could be titrated from 50 mg QD to 100 mg QD<br>|
| Experimental: E<br> | Drug: Sitagliptin phosphate<br>* Double-blind period (12 wk); 50 mg QD The double-blind period will be followed by a 40 wk open-label extension period where MK-0431/ONO-5435 could be titrated from 50 mg QD to 100 mg QD<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | 12 weeks | 
| safety |  | 52 weeks | 
| tolerability |  | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma glucose |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MK-0431, ONO-5435, Type 2 diabetes mellitus
Dermal Phototoxicity Study

Study Overview
=================
Brief Summary
-----------------
Dermal Safety study to determine the Phototoxicity Potential of FMX-101 4% in Healthy Volunteers

Official Title
-----------------
A 4-Day, Randomized, Controlled Study to Evaluate the Phototoxicity Potential of FMX-101, 4% in Healthy Volunteers

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: FMX101


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male or female volunteers age 18 years or older Has uniformly-colored skin on the lower thoracic area of the back which allowed discernment of erythema, and were Fitzpatrick Skin Types I, II, or III Exclusion Criteria: Has any visible disease at the application site which, in the opinion of the investigative personnel, would have interfered with the evaluation of the test site reaction Are unwilling or unable to refrain from the use of sunscreens, cosmetics, creams, ointments, lotions or similar products on the back during the study

Ages Eligible for Study
-----------------
Minimum Age: 18 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: FMX-101<br> | Drug: FMX101<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison between Test and Vehicle sites of the post-irradiation erythema severity at 96 hours post-application using a dermal response numerical equivalent score |  | 4 days |
Ethyl-EPA Treatment of Prodromal Patients

Study Overview
=================
Brief Summary
-----------------
This is an open-label trial of an omega-3 fatty acid for symptoms of the schizophrenia prodrome.

Official Title
-----------------
Ethyl-EPA Treatment of Prodromal Patients

Conditions
-----------------
Schizophrenia Prodrome

Intervention / Treatment
-----------------
* Drug: ethyl-eicosapentaenoic acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: meets criteria for schizophrenia prodrome Exclusion Criteria: any lifetime antipsychotic treatment

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 35 Years

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

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

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: A<br> | Drug: ethyl-eicosapentaenoic acid<br>* 2 mg per day<br>* Other names: ethyl-EPA, an omega-3 fatty acid;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| conversion to psychosis |  | one year |
Efficacy and Safety of 3% Minoxidil Lotion for Beard Enhancement

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine efficacy and safety of 3% minoxidil lotion for beard enhancement.

Official Title
-----------------
Efficacy and Safety of 3% Minoxidil Lotion for Beard Enhancement : A Randomized, Double-blind, Placebo-controlled Study

Conditions
-----------------
Beard Enhancement

Intervention / Treatment
-----------------
* Drug: 3 % Minoxidil lotion
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male Exclusion Criteria: serious underlying diseases. history of beard/ hair treatment before 6 months history of surgery or trauma on beard area. history of minoxidil allergy

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

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

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 |
| --- | --- |
| Experimental: Minoxidil<br>3% Minoxidil lotion is applied twice daily to the beard. | Drug: 3 % Minoxidil lotion<br> <br> |
| Placebo Comparator: Placebo<br>Placebo is applied twice daily to beard. | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of global photographic assessment after 16 weeks from baseline |  | baseline and 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in number of hairs after 16 weeks from baseline |  | baseline and 16 weeks |
Oral Contraceptives in Reproductive Age Women

Study Overview
=================
Brief Summary
-----------------
Contraception is an important issue in public health; especially when maternal risks and morbidities are considered. There is a need for consciousness about the contraceptive choices. The reproductive age women in Turkey may be stubborn or may choose to believe heath information. The oral contraceptive drugs are not used because of wrong beliefs. This survey study aims to investigate the consciousness and knowledge about the oral contraceptives in 3 different areas in Turkey.

Detailed Description
-----------------
In this study; surveys will be given to reproductive age women admitting to the obstetrics and gynecology departments in 3 different cities of Turkey. Survey questions start with the education and socioeconomical status of the participants. Mainly the questions include the knowledge, ever use about oral contraceptives.

Official Title
-----------------
The Awareness About Oral Contraceptives in Reproductive Age Women

Conditions
-----------------
Contraception Behavior

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The women admitting to the clinics - Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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 |
| --- | --- | --- |
| Knowledge about oral contraceptives | The number of participants who had knowledge about the correct use of OC pills | 6 months of survey study | 
| Contraindications of OC pills | The number of participants who know the contraindications of OC pills /The number of participants who think that OC pills cause infertility | 6 months of survey study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knowledge difference in between different regions | The number of participants who had knowledge about the correct use of OC pills in different regions | 6 months of survey study | 
| Oral contraceptive use | The number of participants that have ever used oral contraceptive pills | 6 months of survey study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
oral contraceptives, knowledge
Plasma Circulating Deoxyribonucelic Acid (DNA) as a Response Marker

Study Overview
=================
Brief Summary
-----------------
This study investigates whether the amount of circulating plasma DNA can be used as a response marker for anti-cancer treatment in treating gross tumors.

Conditions
-----------------
Head and Neck Cancer, Esophageal Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Head and neck cancers Esophageal cancer Undergoing anti-cancer treatments Exclusion Criteria: No distant metastasis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
plasma circulating DNA, hean and neck cancers, esophageal cancer, localized head and neck cancers, localized esophageal cancer
PITUItary Carcinoma or Aggressive Tumors REgistry -Lyon

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to observe predictors of pituitary tumor recurrence and markers of persistent disease activity through computerized collection of comprehensive demographic, therapeutic, pathologic and outcome information on patients harboring pituitary mass lesions of all types.

Official Title
-----------------
PITUItary Carcinomas or Aggressive Tumors REgistry: Monocentric Study Form a Cohort of Patient Operated on for Pituitary Tumors in University Hospital of Lyon (France)

Conditions
-----------------
Pituitary Tumor

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • patients with confirmed pituitary disease Exclusion Criteria: • patients who do not have confirmed pituitary disease
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 |
| --- | --- | --- |
| Progression free survival after pituitary surgery according to the clinicopathological classification (HYPOPRONOS) | Clinical, biochemical et imaging evaluation of a cohort of patient operated in the referral center for pituitary tumor. Identification of recurrence or progression an analysis of the clinicopathological classification. Evaluation of the different therapeutic strategies (med, surgery, chemotherapies, radiation therapy) to prevent recurrence or tumor progression. | up to 10 years (postoperatively) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between percentage of SSTR expression of the pituitary tumor and somatostatine analogs efficacy. | Analysis of the expression of SST receptors in GH, PRL and ACTH secreting pituitary tumors: SSTR expression accessed by immunohistochemistry of the pituitary tumor. Evaluation of the response to somatostatine analogs: somatostatine analogs efficacy evaluated by normalization of hormone hypersecretion in ACTH, GH and PRL secreting pituitary tumor. | 2007-2020 | 
| Correlation between percentage of MGMT expression of the pituitary tumor and tumor response to temozolomide. | Evaluation of MGMT expression (accessed by immunohistochemistry of the pituitary tumor) and response to temozolomide treatment (evaluated according to RECIST criteria) for patient presenting multirecurrent tumors resistant to conventional treatment. | 2007-2020 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pituitary tumor, pituitary carcinoma, acromegaly, cushing, prolactinoma
Nonoperative Treatment of Acute Achilles Tendor Rupture

Study Overview
=================
Brief Summary
-----------------
A prospective, non-randomised, observational study to investigate the clinical and biomechanical outcomes and prevalence of reruptures after operative or nonoperative treatment of acute achilles tendon rupture.

Official Title
-----------------
Nonoperative Treatment of Acute Achilles Tendor Rupture in Central Finland: Prospective Cohort Study

Conditions
-----------------
Achilles Tendon Rupture

Intervention / Treatment
-----------------
* Procedure: Operative treatment
* Procedure: Nonoperative treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: acute achilles tendon rupture with clear onset of symptoms closed rupture resides in the catchment area of our hospital district Exclusion Criteria: avulsion fractures in the calcaneus unwillingness to participate inability to communicate using Finnish language

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| Operative treatment<br>Patients having undergone an operative treatment of achilles tendon rupture | Procedure: Operative treatment<br>* Open surgical repair of tendon rupture<br>|
| Nonoperative treatment<br>Patients having undergone a nonoperative treatment with functional rehabilitation of achilles tendon rupture | Procedure: Nonoperative treatment<br>* Nonoperative treatment with lower leg orthosis and functional rehabilitation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rerupture rate | Rate rerupture of a healed tendon after the end of the intervention | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical Activity Level | Patient activity 1 year after the rupture using the Tegner activity level scale which varies from 0 to 10. This scale that aims to provide a standardized method of grading work and sporting activities. | 1 year | 
| University of California, Los Angeles (UCLA) score | Patient activity 1 year after the rupture | 1 year | 
| Achilles tendon rupture score (ATRS) | Achilles tendon rupture score 1 year after the rupture | 1 year | 
| Functional Score | Leppilahti score measuring subjective and objective functional outcome 1 year after the rupture on a scale 0-100. | 1 year | 
| Foot inversion | Foot inversion angle in rest | 1 year | 
| Foot flexion-extension | Foot flexion-extension angle in rest | 1 year | 
| Heel-raise test | One leg heel-raise test while standing | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
achilles tendon rupture, nonoperative treatment, functional rehabilitation, operative treatment, biomechanical measurements
Geographic Modeling of Traffic and Asthma Rates

Study Overview
=================
Brief Summary
-----------------
This study surveys the parents/guardians about symptoms and diagnosis of asthma in kindergarten and first-grade students in 13 schools around the city of Anchorage, Alaska. Traffic information is also measured and entered in geographical information mapping system with student's home and school locations. The study will assess whether students living in high traffic areas have greater risk of diagnosis of asthma.

Detailed Description
-----------------
Survey was distributed through the schools. Parents/guardians were asked about indoor exposures such as environmental tobacco smoke, insects, mold, woodstoves, as well as demographic information about the child and housing type, income,also biologic information about parental asthma. Questions included symptoms of respiratory illness as well as wheezing and medication use. Civil engineering department measured traffic on local roadways and gathered traffic information from state and municipal sources regarding traffic on arterioles and major traffic arteries. All information was entered into geographical information system (GIS) including the closest cross-streets to the child's home and the school location. Traffic exposure variables are being developed for each child and will be added to the database on indoor exposures. A regression model will be used to determine the significance of traffic exposure in receiving a diagnosis of asthma for children five to seven years of age.

Conditions
-----------------
Asthma

Participation Criteria
=================

Study Plan
=================
How is the study designed?
-----------------
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
-----------------
childhood asthma, traffic
Safety and Efficacy Active Drug vs. Placebo in Subjects With Asthma

Study Overview
=================
Brief Summary
-----------------
This study is a double-blind, parallel-group, randomized study of active drug vs placebo in asthma.

Official Title
-----------------
A Phase 1b, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate Safety and Efficacy of Oral Zavegepant in Subjects With Mild Allergic Asthma

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: Zavegepant
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with Asthma Exclusion Criteria: -

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: Sequential Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BHV3500<br>Zavegepant 150 mg BID | Drug: Zavegepant<br>* 150 mg BID<br>* Other names: BHV3500;|
| Placebo Comparator: Placebo<br>Matching placebo 150 mg BID | Drug: Placebo<br>* Placebo matching active drug<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Allergen induced late asthmatic response (LAR) | FEV1 | 3-7 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Allergy, Asthma
ECV - Epihunter Clinical Validation

Study Overview
=================
Brief Summary
-----------------
The goal of this prospective study is to validate a wearable EEG seizure detection solution compared to video EEG. Subjects that undergo a clinical video EEG are asked to additionally wear a wearable EEG headband for up to 2 periods of 4h during the video EEG.

Official Title
-----------------
ECV - Epihunter Clinical Validation

Conditions
-----------------
Absence Seizures, Absence Epilepsy

Intervention / Treatment
-----------------
* Device: Epihunter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects should have an indication of having absence seizures Subjects should be admitted for video EEG monitoring as part of their clinical practice Age > 4 years Exclusion Criteria: Head circumference should be compatible for wearable EEG device (40-70cm) The subject should be able to understand instructions and refrain from removing the device from its head

Ages Eligible for Study
-----------------
Minimum Age: 4 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: All subjects<br>Subjects that undergo a clinical video EEG are asked to additionally wear a wearable EEG headband for up to 2 periods of 4h during the video EEG. | Device: Epihunter<br>* Subjects wear epihunter during routine video EEG<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity for electrographic seizures of study device compared to video EEG | The sensitivity for electrographic seizures by the study device compared to manually annotated electrographic seizures on non-video EEG is > 0.90 (median sensitivity per patient) | 9 months | 
| Number of false alarms by study device per hour | The number of false alarms by the study device < 0.1 per hour (median false detection rate per recording) | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility testing of automated behavioral testing triggered by automated detection | Assess if automated behavioral testing triggered by automated detection can be used to automatically assess awareness during an absence seizure. Successful if subjects DO NOT react to the testing during an unaware seizure, and DO react during an aware seizure. | 3 months |