linjc16/ctgov huggingface dataset:
A Study to Evaluate the Efficacy of Seasonique for the Treatment of Cyclic Pelvic Pain

Study Overview
=================
Brief Summary
-----------------
This study is being conducted to evaluate the effects of treatment with Seasonique an extended-regimen oral contraceptive that utilizes low dose ethinyl estradiol during the typical hormone-free interval. Patients will receive 26 weeks of treatment. The overall study duration will be approximately 9 months. Patients will be required to record menstrual pain in a daily diary.

Official Title
-----------------
A Study to Compare the Efficacy of an Extended-cycle Oral Contraceptive, Seasonique Which Utilizes Ethinyl Estradiol During the Usual Hormone-free Interval Compared to Conventional Oral Contraceptive Therapy for Cyclic Pelvic Pain

Conditions
-----------------
Dysmenorrhea

Intervention / Treatment
-----------------
* Drug: levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablets
* Drug: levonorgestrel/EE 0.15/0.03 mg tablets and placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Moderate to severe menstrual-related pain Regular spontaneous menstrual cycles Exclusion Criteria: Any contraindication to the use of oral contraceptives Treatment with an oral contraceptive in the last 3 months Previous treatment failure with an extended oral contraceptive regimen

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: levonorgestrel/EE 0.15/0.03 and EE 0.01 mg tablets<br>* 1 tablet daily<br>* Other names: Seasonique;|
| Active Comparator: 2<br> | Drug: levonorgestrel/EE 0.15/0.03 mg tablets and placebo<br>* 1 tablet daily<br>* Other names: Portia;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the clinical assessment of dysmenorrhea |  | Baseline to Week 4,8,12,24, and 26 or early discontinuation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in clinical assessment of dysmenorrhea (assessment of 4 additional symptoms) |  | Baseline to Weeks 4, 8, 12, 24 and 26 or early discontinuation | 
| Incidence of menstrual bleeding and/or spotting |  | Duration of study | 
| Analgesic use |  | Duration of study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cyclic pelvic pain, dysmenorrhea
Capsule Endoscopy in Cystic Fibrosis

Study Overview
=================
Brief Summary
-----------------
Cystic Fibrosis patients continue to have bowel problems even after adequate pancreatic enzyme supplementation. There may be pathology of the lining of the bowel. Capsule endoscopy will be used to photograph the entire bowel.

Detailed Description
-----------------
The capsule endoscope system (Given Imaging, Ltd.) consists of 3 elements: a disposable capsule (PillCamTM SB) that acquires video images during natural propulsion through the digestive system. The video-capsule PillCamTM SB has been cleared by the FDA for use in patients over 10 years of age for the detection of small intestinal disorders. It has been used in patients under age 10 and has been placed with the use of a gastroscope in patients unable to swallow the capsule. In fact, a new delivery device has been introduced recently that facilitates placement of the video-capsule in pediatric patients.For the purposes of this study, only patients over age 10 years who are able to swallow the capsule would be enrolled. There are approximately 450 CF patients in the registry in Israel, with about 300 above the age of 10. Study subjects would be enrolled from this registry population and would be screened for the presence of the contraindications noted above. Patients would be assessed for symptoms of possible small bowel lesions at the time of enrollment including gastrointestinal bleeding, palpable abdominal mass, weight loss, diarrhea, and abdominal pain. Markers of inflammation including stool calprotectin will be assessed in all patients. These data would be recorded for further analysis. Page

Official Title
-----------------
Capsule Endoscopy in Cystic Fibrosis-Screening for Small Bowel Disease in Cystic Fibrosis Patient.

Conditions
-----------------
Cystic Fibrosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inclusion criteria would include those subjects with known CF who are able to give informed consent to undergo capsule endoscopy and whose guardians provide consent as well, if applicable. - Exclusion Criteria Subjects would be excluded if they were felt to be poor surgical candidates as patients may need to undergo surgery in the rare event of retention of the capsule. Patients genotype and lung function will be noted; patients will be excluded if FEV1 < 40%. -

Ages Eligible for Study
-----------------
Minimum Age: 10 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 |
| --- | --- | --- |
| We will examine the entire small bowel |  |  | 
| of CF opatients |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
capsule endoscopy
Identifying Patients With Unrecognized Treatable Diabetic Macular Edema

Study Overview
=================
Brief Summary
-----------------
This trial will assess the incidence of new and/or undiagnosed diabetic macular edema (DME) in diabetic patients that undergo a DME screening exam. The screening exam will consist of medical history, Electronic ETDRS visual acuity assessment, SD-OCT and color fundus photography

Official Title
-----------------
Identifying Patients With Unrecognized Treatable Diabetic Macular Edema

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ability to provide written informed consent and comply with study assessments for the full duration of the study Age > 18 years Patient related considerations Patients with diabetes mellitus Disease related considerations Diabetes mellitus Exclusion Criteria: Prior admission screening within twelve months. Inability to sit for evaluation

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 |
| --- | --- | --- |
| Assess the incidence of new and/or undiagnosed diabetic macular edema. | This trial will assess the incidence of new and/or undiagnosed diabetic macular edema (DME) in diabetic patients that undergo a DME screening exam. The screening exam will consist of medical history, Electronic ETDRS visual acuity assessment, SD-OCT and color fundus photography | 1 day (Patients are only seen once for assessments) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Streamlining and identification of patients at risk of diabetic macular edema | Establish methods for streamlining screening and identification of patients at risk. Establish methods for referral for treatment of patients identified with vision threatening diabetic retinopathy. | 1 day (Patients only seen once for assessments) |
Normal Variability of Tidal Breathing Flow-volume Curves During Sleep in Healthy Children

Study Overview
=================
Brief Summary
-----------------
The study includes a comprehensive health examination with focus on respiratory health and the TBFV recordings using impedance pneumography (Ventica®) during sleep at night in healthy children.

Detailed Description
-----------------
Impedance pneumograpy results in healthy children to generate normal values and to stude the effect of age and gender

Official Title
-----------------
Normal Variability of Tidal Breathing Flow-volume Curves During Sleep in Healthy Children

Conditions
-----------------
Respiration Disorders

Intervention / Treatment
-----------------
* Diagnostic Test: Ventica


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 12 months-71 months, both sexes Healthy at the time of inclusion Signed informed consent Exclusion Criteria: Preterm birth Recurrent bronchitis or recurrent hospitalizations because of a respiratory illness Nasal congestion, adenotonsillar hypertrophy, signs and symptoms of sleep apnea or sleep disordered breathing Acute respiratory infection or hospitalization because of an acute illness within 4 weeks prior to inclusion Personal or family history of asthma Recurrent wheezing without respiratory infection Allergic rhinitis, chronic rhinosinusitis, or other chronic respiratory disorders Atopic dermatitis Diagnosed allergic sensitization Use of asthma rescue or maintenance medication within 4 weeks prior to inclusion Any major chronic illness as judged by the investigators Implanted or external active medical devices such as pacemakers

Ages Eligible for Study
-----------------
Minimum Age: 12 Months
Maximum Age: 71 Months

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Ventica|Impedance pneumography measurement|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ventica measurement | level of overnight tidal breathing flow volume variation | overnight measurement |
Gait Speed at Discharge as a Marker for Readmission

Study Overview
=================
Brief Summary
-----------------
The principal aim is to assess if a simple test, the time it takes to walk 10 meters for a patient about to be discharged after a hospital stay for an acute illness, is related to the risk of readmission.

Official Title
-----------------
Gait Speed at Discharge as a Marker for Readmission - The GASP Study

Conditions
-----------------
All Disease That May Require Acute Hospitalization Except for Phsychiatric Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >50 years of age Patient discharged to home, or temporary short stay nursing home Expected survival >90 days The ability to read or understand the instructions and to give informed consent. Exclusion Criteria: Planned hospital stay, i.e. the patient was admitted electively The including investigator is directly involved in the care of the patient

Ages Eligible for Study
-----------------
Minimum Age: 51 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 |
| --- | --- | --- |
| Readmission |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Readmissions |  | 90,180, 365 days | 
| All-cause mortality |  | 6, 12, 24, 36, 60 months |
Correlation Between Body Mass Index and Gonadotrophin Secretions in Pcos Patients and Their Effect on Ivf Outcome

Study Overview
=================
Brief Summary
-----------------
It is Correlation Between Body Mass Index and Gonadotrophin Secretions in Pcos Patients and Their Effect on Ivf Outcome

Official Title
-----------------
Correlation Between Body Mass Index and Gonadotrophin Secretions in Pcos Patients and Their Effect on Ivf Outcome (Randamized Control Trial)

Conditions
-----------------
Correlation Between Body Mass Index and Gonadotrophin Secretions in Pcos Patients and Their Effect on Ivf Outcome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cases of PCO Exclusion Criteria: amenorrhea womenwho had previous IVF
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Body Mass Index less than 30<br> | |
| Body Mass Index more than 30<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gonadotrophin Secretions in both groups |  | 6 months |
The Effect of Z-338 in Subjects With Functional Dyspepsia

Study Overview
=================
Brief Summary
-----------------
Z-338; PhaseIIb, Single-centre, Randomized, Double-blind, Placebo-controlled, Parallel group study in Subjects with Functional Dyspepsia, evaluate the motility of gastro-duodenum by ultrasound

Official Title
-----------------
The Effect of Z-338 in Subjects With Functional Dyspepsia, Evaluate the Function of Gastro-duodenum by Ultrasound

Conditions
-----------------
Functioanl Dyspepsia

Intervention / Treatment
-----------------
* Drug: Z-338


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Postprandial fullness, upper abdominal bloating and/or early satiety should be at least moderate for 2 days or more at the 7 days at Visit 1. Upper abdominal pain, upper abdominal discomfort, postprandial fullness, upper abdominal bloating, early satiety, nausea, vomit and belching should be at least moderate for at least 2 symptoms for 2 days or more at the 7 days at Visit 1. Exclusion Criteria: Subjects that heartburn should be the most bothersome symptom Subjects presenting with primary complaints relieved by stool movements (IBS) Subjects with diabetes by treatment Subjects that heartburn should be more than moderate

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 79 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: Z-338|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distal stomach square, Gastric emptying, Motility index, Duodenogastric reflux index |  |  |
A Phase 2 Study of OPC-262 in Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
A multicenter, randomized, double-blind, placebo-controlled, group-comparison study to investigate the safety and efficacy of OPC-262 in patients with type 2 diabetes

Official Title
-----------------
A Phase 2 Study of OPC-262 in Patients With Type 2 Diabetes

Conditions
-----------------
Diabetes, Type 2

Intervention / Treatment
-----------------
* Drug: saxagliptin
* Drug: saxagliptin
* Drug: saxagliptin
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes patients with HbA1c above 7.0% and below 10% Patients who are capable of giving informed consent Patients who are able to take contraceptive measures to avoid pregnancy of the patient or the patient's partner Exclusion Criteria: Patients with type1 diabetes mellitus, patients with diabetes mellitus or impaired glucose tolerance (IGT) due to other specified mechanism or diseases, and patients with gestational diabetes mellitus Patients with a medical history of diabetes coma Patients with poorly-controlled hypertension Patients with heart failure Patients with a complication of active hepatitis or hepatic cirrhosis Patients undergoing treatment of glomeruler diseases other than diabetic nephropathy Patients with a history or complication of malignant tumor

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>OPC-262 1mg | Drug: saxagliptin<br>* orally administration at 1 mg once a day for 12 weeks<br>|
| Experimental: 2<br>OPC-262 2.5mg | Drug: saxagliptin<br>* orally administration at 2.5 mg once a day for 12 weeks<br>|
| Experimental: 3<br>OPC-262 5mg | Drug: saxagliptin<br>* orally administration at 5 mg once a day for 12 weeks<br>|
| Placebo Comparator: 4<br> | Drug: placebo<br>* orally administration once a day for 12 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in HbA1C from baseline |  | 2w, 4w, 8w, 12w, 16w | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| values and changes in HbA1c form baseline |  | 2w, 4w, 8w, 12w, 16w | 
| values and changes in fasting blood glucose (FSB) from baseline |  | 2w, 4w, 8w, 12w, 16w | 
| adverse event |  | at any time |
Rapamycin In Angiomyolipomas In Patients With Tuberous Sclerosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether rapamycin is safe and effective in the treatment of renal angiomyolipomas in patients with tuberousclerosis.

Official Title
-----------------
CLINICAL TRIAL TO DETERMINE THE EFFICACY AND SAFETY OF RAPAMYCIN IN ANGIOMYOLIPOMAS IN PATIENTS WITH TUBEROUS SCLEROSIS

Conditions
-----------------
Angiomyolipoma

Intervention / Treatment
-----------------
* Drug: Sirolimus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of tuberousclerosis Angiomyolipoma >2cm age>10 years Exclusion Criteria: Creatinine >4 No recent AML bleeding No hepatic abnormalities (liver tests 2fold) Hematocrit<27% Thrombocytopenia (<100.000/mm3) Leukopenia (<3000/mm3) Ischemic cardiopathy Recent surgery (2 months prior to enrollment) Pregnancy Serum cholesterol over 7.8 mmol/l or hypertriglyceridemia fasten(>4.6 mmol/l) non controlled with drugs malignancy in the previous 2 years allergy to macrolides

Ages Eligible for Study
-----------------
Minimum Age: 10 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

| Intervention/Treatment |
| --- |
|Drug: Sirolimus|plasma levels between 4 and 8|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Angiomyolipoma volume | Measured by MRI | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| skin lesions, AML complications, | Evaluate skin lesions Collect event realted to AML | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tuberousclerosis, angiomyolipoma, rapamycin
A Clinical Study of Subclinical Enthesitis and Synovitis in Patients With Vulgaris Psoriasis

Study Overview
=================
Brief Summary
-----------------
A clinical study of subclinical enthesitis and synovitis in patients with vulgaris psoriasis

Detailed Description
-----------------
A total of 100 patients with vulgaris psoriasis and 100 age-matched controls with other skin diseases, all without musculoskeletal diseases, will be recruited. They will undergo dermatological assessment and a blinded PDUS evaluation. Clinical assessment included demographics, severity of psoriasis, musculoskeletal clinical examination and sport activities. PDUS evaluation consisted of the detection of grey scale (GS) synovitis and synovial PD signal in joints of extremities, GS enthesopathy and entheseal PD signal in entheses of lower limbs.

Official Title
-----------------
A Clinical Study of Subclinical Enthesitis and Synovitis in Patients With Vulgaris Psoriasis

Conditions
-----------------
Vulgaris Psoriasis

Intervention / Treatment
-----------------
* Other: PDUS examination


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age≥18years patients with vulgaris psoriasis(dur patients with other skin diseases without musculoskeletal disorders no joint involvement and no clinical symptoms and signs of enthesitis and synovitis Exclusion Criteria: BMI≥24 have history of gout or arthritis or peripheral neurological disease of lower extremity or trauma have received any systemic therapy(i.e.NSAIDs, corticosteroids, immunosuppressants, retinoids or biological agents) in 3 months pregnant or breast-feeding

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| case group<br>100 patients with vulgaris psoriasi without arthritis | Other: PDUS examination<br> <br> |
| control group<br>100 age-matched patients with other skin diseases without arthritis | Other: PDUS examination<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of subclinical enthesitis and synovitis | To investigate the incidence of subclinical enthesitis and synovitis in patients with vulgaris | one and a half year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with Risk factors of subclinical enthesitis and synovitis | To find out predictor factors of subclinical enthesitis and synovitis in patients with vulgaris psoriasis | one and a half year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
subclinical, enthesitis, synovitis