linjc16/ctgov huggingface dataset:
Evaluating the Occurence of New and Progression of Existing Peripheral Venous Disease in Leg Veins

Study Overview
=================
Brief Summary
-----------------
Peripheral venous disease occurs when a vein becomes damaged or blocked. It can occur almost anywhere in the body, but is most common in the arms and legs. This study will examine people who participated in a previous venous disease study to evaluate changes in leg veins and venous disease status over a period of 11 years.

Detailed Description
-----------------
Peripheral venous disease is a general term for damage, defects, or blockage that occurs in the peripheral veins, which carry blood from the hands and feet back to the heart to receive oxygen. The most common cause of peripheral venous disease is a blood clot that blocks a vein. Varicose veins, which are swollen blood vessels near the surface of the skin, and chronic venous insufficiency, a condition in which blood in the leg veins does not drain properly, are two other common types of peripheral venous disease. From 1996 to 2000, the San Diego Population Study (SDPS) evaluated a group of individuals to gather information on the prevalence of venous disease. This current study will re-evaluate the SDPS participants to document changes that have occurred in their leg veins over the past 11 years, including any new venous disease and any progression of existing venous disease. Study researchers will also evaluate how venous disease relates to risk factors, symptoms, and quality of life issues. This study will enroll people who participated in the SDPS study. Each participant will attend one study visit. Study staff will conduct a 1-hour interview with each participant to collect information on their medical history, disease-related symptoms, risk factors for venous disease, family health history, health habits, and quality of life. Blood collection will occur, participant's leg veins will be examined and photographed, and blood flow in the legs will be measured with an ultrasound.

Official Title
-----------------
Incidence and Progression of Peripheral Venous Disease

Conditions
-----------------
Peripheral Vascular Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participated in the SDPS study
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 |
| --- | --- | --- |
| Incident Venous Disease |  | Since previous visit (approximately 11 years) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Venous Disease, Varicose Veins, Chronic Venous Insufficiency, PAD
Gingival Wetness and Gingival Crevicular Fluid Volume in Patients With Dry Mouth

Study Overview
=================
Brief Summary
-----------------
The investigators questioned whether patients with dry mouth complaints display any reduction in residual saliva coating the gingiva and other selected mucosal surfaces. We further intended to test the hypothesis that Gingival Crevicular Fluid volume in patients with dry mouth could be different from that of control subjects. Correlations between gingival/mucosal wetness; and unstimulated whole salivary flow rate or minor salivary gland secretion rates and the correlations between clinical periodontal status and salivary measures were also attempted.

Official Title
-----------------
Gingival Wetness and Gingival Crevicular Fluid Volume in Patients With Dry Mouth

Conditions
-----------------
Xerostomia, Sjogren's Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: For test group dry mouth complaints and with a diagnosis ofSjogren's Syndrome Exclusion Criteria: Other medical problems that effect salivary glands

Ages Eligible for Study
-----------------
Minimum Age: 46 Years
Maximum Age: 56 Years

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

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
-----------------
Saliva, Sjögren's Syndrome, GCF, Oral Mucosal Wetness
Psychological Distress and Outcomes in Hip Preservation Patients

Study Overview
=================
Brief Summary
-----------------
This is an investigatory study to determine whether high levels of pre-operative psychological distress predict worse outcomes after hip preservation. This is a low risk study and does not alter the treatment or course of care for patients undergoing this procedure

Detailed Description
-----------------
The correlation between increasing psychological distress and worsening surgical outcomes has been extensively documented in patients undergoing spine surgery. However, we have no reason to believe that patients with hip pathology are uniquely exempt from the influence of psychosocial factors. To our knowledge, no study has been done to evaluate the effect of pre-operative psychological distress on outcomes after hip preservation surgery. We therefore propose to use the DRAM to measure pre-operative distress in patients undergoing open or arthroscopic hip preservation surgery and to compare these pre-operative distress scores with post-operative outcomes. We hope the information we gain will allow clinicians to comprehensively evaluate the patient with hip pain and to make more informed choices about operative treatment.

Official Title
-----------------
Pre-Operative Psychological Distress and Post-Operative Outcomes in Hip Preservation Patients

Conditions
-----------------
Psychological Distress

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary presenting complaint of hip pain Hip arthroscopy, surgical dislocation and debridement, and/or periacetabular osteotomy performed by Dr. Aoki or Dr. Peters for hip pathology diagnosed by history, clinical examination and/or imaging Exclusion Criteria: Unable to complete the DRAM questionnaire Patients who do not undergo surgery

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distress and Risk Assessment Method (DRAM) questionaire | Distress and Risk Assessment Method (DRAM) questionaire to screen for psychological distress. The instrument defines four categories based on patients responses: Type N (normal; lower scores, no evidence of distress); Type R (at risk; higher scores, primarily in symptoms of depression); Type DD (distressed-depressive; higher scores on all variables, but very high on depressive symptomatology); and Type DS (distressed-somatic; higher scores on all variables, but very high on somatic awareness). | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hip Preservation, Hip Arthroscopy, Hip Pain, Psychological distress
DMSO-PDT of BCC - A 6 Year Follow up

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to registrate long time clinical and histological treatment response of basal cell carcinoma (BCC) lesions treated with one or two procedures of dimethylsulfoxide supported 5-aminolaevulinic acid photodynamic therapy (DMSO-PDT).

Official Title
-----------------
Dimethylsulphoxide-supported Photodynamic Therapy of Basal Cell Carcinoma Combined With Curettage - A 6 Year Clinical and Histological Evaluation.

Conditions
-----------------
Carcinoma, Basal Cell

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: histological verified bcc. one or two PDT treatments with treatment interval no longer than two weeks. lesion complete response three months after therapy. Exclusion Criteria: pregnant. Gorlin's syndrome. morpheaform or pigmented bcc. histology older than one year. tumour infiltration more than four mm. previous PDT treated lesions.

Ages Eligible for Study
-----------------
Minimum Age: 18 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
-----------------
Photodynamic treatment, Basal cell carcinoma, DMSO
Misoprostol Versus Oxytocin for Prevention of Post Partum Hemorrhage

Study Overview
=================
Brief Summary
-----------------
Post partum Hemorrhage (PPH) is one of three main causes of death in pregnant women. Oxytocin is widely used for prevention of PPH. Some studies suggested misoprostol as an alternative treatment when Oxytocin isn't available. The aim of this study is to compare the safety and efficacy of Oxytocin and misoprostol for prevention of PPH.

Detailed Description
-----------------
In a double blind randomized controlled trial 400 pregnant women who has vaginal delivery at Shariati hospital are assigned into two groups either to receive 20 unite oxytocin in 1000cc ringer and 2 placebo tablet or 400mcg oral misoprostol and 2cc normal saline in 1000cc ringer.

Official Title
-----------------
Safety and Efficacy of Misoprostol Versus Oxytocin for Prevention of Post Partum Hemorrhage

Conditions
-----------------
Post Partum Hemorrhage

Intervention / Treatment
-----------------
* Drug: Misoprostol
* Drug: Oxytocin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: were women with singleton pregnancy with cephalic presentation who had NVD spontaneously or by induction Exclusion Criteria: placenta previa placental detachment coagulation problems previous CS macrosomia Polyhydramnios and uncontrolled asthma

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Misoprostol<br>400µg oral misoprostol | Drug: Misoprostol<br>* 400µg oral misoprostol<br>* Other names: Cytotec;|
| Active Comparator: Oxytocin<br>20 IU oxytocin | Drug: Oxytocin<br>* 20 IU Oxytocin<br>* Other names: Syntocinon;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of bleeding | within 1 hours after delivery | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin decrease |  | 24 hours | 
| Hematocrite decrease |  | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Misoprostol, Oxytocin, Post Partum Hemorrhage (PPH), Third stage of labour
A Study With Gemcitabine, Cisplatin, and LY293111 in Non-Small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effectiveness and side effects of LY293111 given in combination with gemcitabine and cisplatin in patients with non-small cell lung cancer.

Official Title
-----------------
Randomized, Placebo-Controlled, Double-Blind, Phase 2 Study of Gemcitabine-Cisplatin Combined With Two Different Doses of LY293111 or Placebo in Patients With Stage IIIB or IV Non-Small Cell Lung Cancer

Conditions
-----------------
Carcinoma, Non-Small-Cell Lung

Intervention / Treatment
-----------------
* Drug: Gemcitabine
* Drug: LY293111
* Drug: cisplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Non-Small Cell Lung Cancer, Stage IIIB or IV that is not amenable to either surgery of curative intent or radiation therapy Tumor that can be measured by x-ray or scan Adequate organ function Exclusion Criteria: Inability to swallow capsules Documented brain metastases Prior chemotherapy or biological therapy for this disease

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

| Intervention/Treatment |
| --- |
|Drug: Gemcitabine|nan|
|Drug: LY293111|nan|
|Drug: cisplatin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine if progression-free survival in patients with Stage IIIB or IV NSCLC receiving gemcitabine and cisplatin can be improved by adding 200 or 600 mg BID of LY293111 as compared to placebo. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time-to-event efficacy (overall survival, duration of response, time-to-response, time-to-treatment failure) |  |  | 
| tumor response rate |  |  | 
| toxicity rates |  |  | 
| exposure-response relationship |  |  | 
| quality of life |  |  |
An Observational Study of Risk Factors and Long-term Prognosis of Patients With Liver Abscess in the Real-world

Study Overview
=================
Brief Summary
-----------------
Pyogenic liver abscess is one of the most common visceral abscesses, its incidence is increasing worldwide. According to the previous literature, the mortality rate of pyogenic liver abscess is as high as 31% and become a serious social health problem. However, the data of prospective observational real-world studies are scarce and no relevant research of the liver histological change has been reported, so the long-term prognosis and the risk factors for pyogenic liver abscess are still unknown. Patients will be followed up prospectively for a period of 2 years and observed clinical prognosis (all-cause mortality, the recurrence rate, and the rehospitalization rate). The investigators will investigate the predictive value of clinical risk factors for clinical prognosis and establish clinical prediction models to predict the long-term prognosis of pyogenic liver abscesses.

Official Title
-----------------
An Observational Study of Risk Factors and Long-term Prognosis of Patients With Pyogenic Liver Abscess in the Real-world

Conditions
-----------------
Infections, Liver Abscess, Pyogenic, Liver Abscess, Abscess

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients older than 18 years of age; Irrespective of gender; Symptomatic patients of liver abscess confirmed with radiology imaging, either by ultrasonography or computed tomography scan. Exclusion Criteria: Patients <18 years old; Pregnancy at presentation.

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Proportion and causes of deaths within 2 years of discharge from hospital | Define the proportion and causes of deaths within 2 years of discharge from hospital for patients admitted to the Department for pyogenic liver abscesses. | 2 years | 
| Proportion and causes of re-hospitalization within 2 years of discharge from hospital | Define the proportion and causes of re-hospitalization within 2 years of discharge from hospital for patients admitted to the Department for pyogenic liver abscesses. | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The recurrence rate of pyogenic liver abscess | Development new liver abscess after clinical cure during the 2 years follow up period | 2 years | 
| The number of participants with Histological Change in the Liver | Assessment of histological change in the liver by using ultrasonography or transient elastography during the 2 years follow up period | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pyogenic Liver abscess, Liver histological change
A Randomized, Double-blind, Placebo-controlled, Dose Response Study of AMG 162 (Denosumab) in Japanese Postmenopausal Osteoporotic Subjects

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to assess the effect of AMG 162 (denosumab) treatment on the lumbar spine BMD at month 12 and safety profile across the dose range tested (14, 60 and 100 mg SC once every 6 months) in Japanese postmenopausal osteoporotic subjects compared with those treated with placebo over 12 months.

Official Title
-----------------
Dose Response Study of AMG 162 (Denosumab) in Subjects With Osteoporosis - A Randomized, Double-blind, Placebo-controlled, Dose Response Study of AMG 162 (Denosumab) in Japanese Postmenopausal Osteoporotic Subjects -

Conditions
-----------------
Osteoporosis

Intervention / Treatment
-----------------
* Drug: 100 mg AMG 162
* Drug: 60 mg AMG 162
* Drug: 14 mg AMG 162
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Ambulatory postmenopausal women. - BMD values (g/cm2, Hologic) must be lower than 0.714 at lumbar spine, 0.515 at femoral neck, 0.588 at total hip. - BMD values must not be lower than 0.535 at the lumbar spine, 0.406 at the femoral neck and 0.478 at the total hip. Exclusion Criteria: - Oral bisphosphonate treatments, PTH or PTH derivatives use within the last 12 months and administration of any of anti-osteoporotic treatments within the last 3 months before initial administration of the investigational product. - History of hypocalcemia. - More than two moderate vertebral fractures or any severe vertebral fracture.

Ages Eligible for Study
-----------------
Maximum Age: 80 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 100 mg AMG 162<br> | Drug: 100 mg AMG 162<br>* 100 mg AMG 162 (denosumab) SC every 6 months<br>|
| Active Comparator: 60 mg AMG 162<br> | Drug: 60 mg AMG 162<br>* 60 mg AMG 162 (denosumab) SC every 6 months<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo SC every 6 months<br>|
| Active Comparator: 14 mg AMG 162<br> | Drug: 14 mg AMG 162<br>* 14 mg AMG 162 (denosumab) SC every 6 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lumbar Spine Bone Mineral Density Percent Change From Baseline at Month 12 | Bone Mineral Density Assessed by Dual Energy X-Ray Absorptiometry. | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
RANKL, RANK, denosumab, AMG 162, osteoporosis, bone turnover, bone mineral density, Japanese
Safety and Intraocular Pressure (IOP) Lowering Efficacy of Low Dose Travoprost

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the safety and IOP-lowering efficacy of various low dose travoprost formulations in patients with open-angle glaucoma or ocular hypertension.

Official Title
-----------------
Safety and IOP Lowering Efficacy of Low Dose Travoprost Ophthalmic Solutions Dosed BID Compared to TRAVATAN® in Patients With Open-Angle Glaucoma or Ocular Hypertension

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

Intervention / Treatment
-----------------
* Drug: Travoprost ophthalmic solution, 0.0008%
* Drug: Travoprost ophthalmic solution, 0.001%
* Drug: Travoprost ophthalmic solution, 0.0012%
* Drug: TRAVATAN
* Other: Vehicle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients 18 years of age or older, either sex or race with open-angle glaucoma or confirmed ocular hypertension Other protocol-defined inclusion criteria may apply Exclusion Criteria: Age related Other protocol-defined exclusion criteria may apply

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Travoprost 0.0008%<br>Travoprost ophthalmic solution, 0.0008%, one drop in study eye(s) twice daily (8 AM and 8 PM), for 2 weeks | Drug: Travoprost ophthalmic solution, 0.0008%<br> <br> |
| Experimental: Travoprost 0.001%<br>Travoprost ophthalmic solution, 0.001%, one drop in study eye(s) twice daily (8 AM and 8 PM), for 2 weeks | Drug: Travoprost ophthalmic solution, 0.001%<br> <br> |
| Experimental: Travoprost 0.0012%<br>Travoprost ophthalmic solution, 0.0012%, one drop in study eye(s) twice daily (8 AM and 8 PM), for 2 weeks | Drug: Travoprost ophthalmic solution, 0.0012%<br> <br> |
| Active Comparator: TRAVATAN + Vehicle<br>TRAVATAN, one drop in study eye(s) once daily (8 PM), and Vehicle, one drop in study eye(s) once daily (8 AM), for two weeks | Drug: TRAVATAN<br> <br> Other: Vehicle<br> <br> |
| Placebo Comparator: Vehicle<br>Vehicle, one drop in study eye(s) twice daily (8 AM and 8 PM), for 2 weeks | Other: Vehicle<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Intraocular Pressure |  | Up to 2 weeks |