linjc16/ctgov huggingface dataset:
CV004-007 Thrombosis Chamber Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether BMS-986120, aspirin, or aspirin and clopidogrel decrease blood clotting.

Official Title
-----------------
A Single Dose Study to Evaluate the Effect of BMS-986120 on Thrombus Formation in an Ex Vivo Thrombosis Chamber Model in Healthy Subjects

Conditions
-----------------
Thrombosis

Intervention / Treatment
-----------------
* Drug: BMS-986120
* Drug: Aspirin
* Drug: Clopidogrel


Participation Criteria
=================
Eligibility Criteria
-----------------
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs and clinical laboratory determinations Body Mass Index (BMI) of 18 to 32 kg/m2 inclusive. BMI = weight (kg)/ [height (m)]2 Females who are not of childbearing potential (i.e., who are post-menopausal or surgically sterile) and men ages 18 to 65, inclusive Azoospermic males and women who are not of child-bearing potential (i.e. are postmenopausal or surgically sterile; see section 3.3.3 for the definition of WOCBP) are exempt from contraceptive requirements. However, women must still undergo pregnancy testing as described in this section Exclusion Criteria: Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population Any condition that could affect drug absorption Other protocol-defined exclusion criteria could apply

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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment A: BMS-986120<br>BMS-986120 on specified days | Drug: BMS-986120<br> <br> |
| Active Comparator: Treatment B: Aspirin and Clopidogrel<br>Aspirin and Clopidogrel on specified days | Drug: Aspirin<br> <br> Drug: Clopidogrel<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in thrombus area (post-treatment with BMS-986120 vs. pre-treatment) |  | 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of BMS 986120 or aspirin administered with and without clopidogrel based on adverse events,clinical laboratory tests, physical examinations and vital signs per the collection schedule |  | 2 days |
Predictive Model for Postoperative Complications in Hemi-hip Arthroplasty

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to identify the major complications and their risk factors of elderly patients who had undergone Hemi-hip Arthroplasty.

Detailed Description
-----------------
We retrospectively reviewed the medical records and reviewed the major complications and identify risk factors of elderly patients who had undergone Hemi-hip Arthroplasty for adults aged 60 years or older from January 2011 to December 2015.

Official Title
-----------------
Predictive Model for Postoperative Complications in Elderly Patients With Hip Arthroplasty: Retrospective Study

Conditions
-----------------
Complication, Risk Factor, Elderly Patient, Arthroplasty

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A patient scheduled to undergo spinal anesthesia for Hemi-hip Arthroplasty Exclusion Criteria: 1) Patients with acute infectious disease before surgery 2) Patients with fractures around the implant 3) Patients who underwent reoperation during hospitalization 4) During the study period, Duplicate patient who underwent the opposite side of the hip during hospitalization

Ages Eligible for Study
-----------------
Minimum Age: 60 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 |
| --- | --- | --- |
| postoperative complications | we collect postoperative complications which include cardiac, pulmonary renal, cerebral, and other complications. | from operation day to postoperative 30 days |
Study to Assess the Safety and Efficacy of Imiquimod 5% Cream for the Treatment of Actinic Keratosis on the Arms and Hands

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and efficacy of imiquimod 5% cream compared to vehicle cream in the treatment of Actinic Keratosis (AK) on the arm and/or hand when the cream is applied once daily 2 days per week for 16 weeks.

Official Title
-----------------
Vehicle-Controlled, Double-Blind Study to Assess the Safety and Efficacy of Imiquimod 5% Cream for the Treatment of Actinic Keratosis on the Upper Extremities

Conditions
-----------------
Keratosis

Intervention / Treatment
-----------------
* Drug: Aldara (imiquimod) cream, 5%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age Have AK on arm or hand Discontinuation of sun tanning and the use of tanning beds Discontinuation of the use of moisturizers, body oils, over-the-counter retinol products and products containing alpha or beta hydroxy acid in the treatment and surrounding area Withholding of the use of sunscreen in the treatment area for 24 hours prior to all study visits and for 8 hours before applying study cream Postponement of the treatment of non-study AK lesions anywhere on the arm being treated until study participation is complete Exclusion Criteria: Subjects must not have any evidence of systemic cancer or immunosuppression or other unstable health conditions Participation in another clinical study Have previously received treatment with imiquimod within the treatment area Have squamous cell carcinoma (SCC), basal cell carcinoma (BCC), or other malignancy in the treatment or surrounding area that requires treatment

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Aldara (imiquimod) cream, 5%|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective of this study is to evaluate the efficacy of imiquimod 5% cream compared to vehicle cream in the treatment of AK on the upper extremities when the cream is applied once daily 2 days per week for 16 weeks. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary objective is to evaluate the safety of treatment with imiquimod 5% cream in subjects with AK lesions on the upper extremities. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Actinic Keratosis, AK, 3M Pharmaceuticals, Aldara, Imiquimod, Actinic Keratosis (AK)
Acute Comfort and Blur Profile of a Lubricant Eye Drop Versus a Marketed Eye Ointment

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the comfort and blurriness of the investigational lubricant eye drop with a marketed artificial tear ointment.

Conditions
-----------------
Dry Eye

Intervention / Treatment
-----------------
* Other: Lubricant eye drop FID 115958D
* Other: Refresh PM Ointment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documented diagnosis of dry eye Exclusion Criteria: Must not have worn contact lenses within 12 hours preceding enrollment Must not have used any topical ocular drops or ointment within 24 hours preceding enrollment

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lubricant eye drop<br>Lubricant eye drop | Other: Lubricant eye drop FID 115958D<br>* 1 drop in each eye, one time<br>|
| Active Comparator: Refresh PM Ointment<br>Refresh PM Ointment | Other: Refresh PM Ointment<br>* 1 drop in each eye, one time<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Three-minute visual blur profile |  | Through 3 minutes (post-instillation) | 
| Overall Acceptability |  | Immediately upon instillation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drop Comfort Upon Instillation |  | Immediately upon installation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dry eye, artificial tears
Comparison of Time and Cost Efficiency in Arthroscopic Shoulder Surgery Under Regional Anesthesia vs General Anesthesia

Study Overview
=================
Brief Summary
-----------------
Arthroscopic Shoulder surgery can be done not only under general anesthesia but also regional technics. In this study we aimed to compare the cost and time effectiveness of regional anesthesia and general anesthesia.

Detailed Description
-----------------
In our routine practice, ultrasound guided brachial plexus blocks or general anesthesia can be used during shoulder surgery. This retrospective study is designed to investigate the data of the patients who underwent arthroscopic shoulder between 01.09.2021-01.09.2022 at Samsun University Education and Research Hospital. As well as patients' demographic data, presence of additional diseases, operation indications, duration of surgery, intraoperative medical agents that are used, duration of hospital stay will be collected from patients files.Fees for materials used for general anesthesia and regional anesthesia will be determined. A fixed cost will be determined for the use of the operating room, including the salaries of the healthcare workers. After final calculation of both of the group costs statistical analysis will be made.

Official Title
-----------------
Comparison of Time and Cost Efficiency in Arthroscopic Shoulder Surgery Under Regional Anesthesia vs General Anesthesia

Conditions
-----------------
Anesthesia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American Society of Anesthesiology (ASA) 1-2-3 Arthroscopic Shoulder Surgery Exclusion Criteria: Emergency surgery ASA -4

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| General<br>Arthroscopic Shoulder Surgery under General Anesthesia | |
| Regional<br>Arthroscopic Shoulder Surgery under Regional Anesthesia | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost of Regional Anesthesia and General Anesthesia | Calculation of peroperative costs of patients undergoing arthroscopic shoulder surgery under general or regional anesthesia. excluding surgical materials | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time | Measuring the operation room usage under general or regional anesthesia | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cost, Regional Anesthesia, Shoulder
Acute Pediatric Fracture Analgesia Study

Study Overview
=================
Brief Summary
-----------------
A clinical trial comparing ibuprofen and acetaminophen with codeine for children after discharge from the emergency department. We hypothesize that Ibuprofen will provide 20% more effective analgesia compared to acetaminophen with codeine in children with uncomplicated forearm fractures.

Detailed Description
-----------------
A clinical trial comparing ibuprofen and acetaminophen with codeine for children after discharge from the emergency department. We hypothesize that Ibuprofen will provide 20% more effective analgesia compared to acetaminophen with codeine in children with uncomplicated forearm fractures. A random table will be used to generate an assignment of the participants to either ibuprofen or acetaminophen with codeine. Assessment of the child's pain severity, pain medication use, functional limitations and parental satisfaction will allow for identification of a difference in the management of pain in the first 72 hours after a forearm fracture. Descriptive statistics will be used to analyze demographic data.

Official Title
-----------------
Ibuprofen Versus Acetaminophen With Codeine In Acute Pediatric Forearm Fractures

Conditions
-----------------
Fracture

Intervention / Treatment
-----------------
* Drug: ibuprofen
* Drug: acetamin w codeine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children ages 4-18 years of age with an uncomplicated forearm fracture that is evaluated within 12 hours of injury and requires only splinting Exclusion Criteria: A history of a bleeding disorder, uncontrolled chronic medical disease, regularly use of or allergy to acetaminophen, ibuprofen, or codeine or developmental delay

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ibuprofen<br> | Drug: ibuprofen<br> <br> * Other names: advil;|
| Active Comparator: acetamin w codeine<br> | Drug: acetamin w codeine<br> <br> * Other names: tylenol with codeine, T3;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change to rescue medication |  | First 72 hours after ED discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score |  | First 72 hours after ED discharge | 
| Functional outcomes: eat, sleep, play, school |  | First 72 hours after ED discharge | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fracture
Diurnal and Nocturnal Effect of Travatan With SofZia Preservative on Intraocular Pressure and Ocular Perfusion Pressure

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to determine the diurnal and nocturnal effects of Travoprost with SofZia (Travatan Z) on intraocular pressure and ocular perfusion pressure.

Detailed Description
-----------------
The investigators hypothesize that Travatan Z will significantly lower intraocular pressure and increase ocular perfusion pressure during both the diurnal and nocturnal period, during a 24-hour evaluation, compared to baseline. The investigators further hypothesize that the medication effects will persist at 72 hours after discontinuation of the drug.

Official Title
-----------------
The Diurnal and Nocturnal Effect of Travatan With SofZia Preservative on Intraocular Pressure and Ocular Perfusion Pressure

Conditions
-----------------
Open Angle Glaucoma, Ocular Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of open-angle glaucoma or ocular hypertension, including pigment dispersion glaucoma and pseudoexfoliation glaucoma Age ≥ 18 or ≤ 90 years, of either gender, or any race/ethnicity Exclusion Criteria: Females who are currently pregnant or planning to become pregnant, as determined by history during the study period Diagnosis of any other form of glaucoma other than open-angle Schaffer angle grade < 2 in either eye by gonioscopy Chronic, recurrent, or severe inflammatory eye disease Intraocular surgery within 6 months or laser within 3 months History of active, recurrent, or chronic ocular infection with the Herpes Simplex Virus History of cystoid macular edema Inability to safely discontinue all ocular medications for 4 weeks Patients who smoke or have irregular daily sleep patterns Patients who have started or changed glucocorticoids therapy in the last 3 months Patients who are currently undergoing medical marijuana therapy Any use of a non-FDA approved medication for glaucoma in the last 3 months

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 |
| --- | --- | --- |
| Changes in Intraocular Pressure | To determine the 24-hour intraocular pressure lowering effect of Travatan Z | Every 2 hours for 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular Pressure Change Duration | Elucidate the duration of effect from Travatan Z administration which may lead to more efficient dosing regimens | 72 hours |
A Prospective Study Comparing the Incidence of Infantile Hemangiomas Following Normal Pregnancies Versus Pregnancies Complicated by Placental Abnormalities

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the pathogenesis of hemangiomas of infancy as they relate to normal pregnancies and those pregnancies complicated by placenta abnormalities. Women of all gestational ages will be enrolled in the study. Maternal serum, placental, and cord blood samples will be obtained for each subject. A medical history will be obtained for each subject. Post-delivery a member of the study team will perform a cutaneous exam of the infant to establish what birthmarks are present at birth. Mother will receive four phone call follow ups to determine if the infant has had any skin changes. If yes, mother will be asked to bring the child in for evaluation. If a hemangioma is diagnosed, a blood draw will be performed.

Conditions
-----------------
Hemangioma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnant women delivering at Sharp Mary Birch Hospital for Women in San Diego, CA
Sexes Eligible for Study
-----------------
Female

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
-----------------
Hemagiomas of infancy
Epidemiology of Venous Thromboembolism

Study Overview
=================
Brief Summary
-----------------
To evaluate potentially modifiable lifestyle predictors of venous thromboembolism and their joint associations with biochemical and genetic determinants.

Detailed Description
-----------------
BACKGROUND: Venous thromboembolism is a common condition with considerable morbidity and mortality. The disorder has diverse causes including trauma, stasis, drugs, cancer, and genetic factors that contribute to enhanced clotting and coagulation. The study uses existing large-scale population studies to unravel factors responsible for and contributing to venous thromboembolism. DESIGN NARRATIVE: The study design is a prospective cohort study of 77,118 persons based on pooling information from four large randomized trials of US health professionals that have collected detailed risk factor information and have used common strategies to prospectively identify and validate cases of venous thromboembolism (VTE). These trials are: Physicians' Health Studies I & II including 29,071 US male physicians, of whom 22,071 have been followed since the initiation of the first trial in 1982; the Women's Health Study including 39,876 female health professionals who will have an average of 10 years of follow-up; and the Women's Antioxidant Cardiovascular Study including 8,171 female health professionals with prevalent cardiovascular disease or at high risk of cardiovascular disease who will have an average of 8 years of follow-up. Archived blood samples were collected from approximately 75 percent of participants at baseline and will be used to assess biochemical and genetic markers of risk including factor V Leiden, the G20210A mutation in the prothrombin gene, hyperhomocysteinemia, and anticardiolipin antibodies. The study will assess the joint association with risk of these markers and potentially modifiable factors including body mass index, hormone replacement therapy, physical activity, and aspirin use. The study population will include over 1,000 incident cases of VTE, including 750 with blood samples.

Conditions
-----------------
Cardiovascular Diseases, Thromboembolism, Peripheral Vascular Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
No human subjects are involved. Collected data are used.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Physicians' Health Study I<br> | |
| Physicians' Health Study II<br> | |
| Women's Health Study<br> | |
| Women's Antioxidant Cardiovascular Health Study<br> | |

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

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