linjc16/ctgov huggingface dataset:
Comparison of DR-2011 to a Progesterone Vaginal Gel for Luteal Phase Replacement

Study Overview
=================
Brief Summary
-----------------
This is a single-center, open-label, randomized, active-controlled study to compare DR-2011 to progesterone vaginal gel for luteal phase replacement.

Detailed Description
-----------------
This is a 2-arm, single-center, open-label, randomized, active-controlled study to compare the safety and efficacy of luteal phase replacement with DR-2011 to progesterone vaginal gel over an 18-day treatment period. Patients will also be required to use an estrogen patch during the course of the study. The overall study duration for each patient will be approximately 1½ months. Luteal phase replacement will be monitored by endometrial biopsy on Cycle Day 25 or 26. In addition, serum hormonal levels will be measured at screening and at designated times from Cycle Day 14 to 31.

Official Title
-----------------
A Phase 2, Single-Center, Open-Label, Randomized, Controlled, Pharmacodynamic Study to Compare DR-2011 to a Progesterone Vaginal Gel for Luteal Phase Replacement

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Drug: DR-2011
* Drug: Progesterone 8% Vaginal Gel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Not pregnant Clinically or medically-induced non-functioning or surgically removed ovaries Clinical investigator believes patient would be eligible for oocyte donation Exclusion Criteria: Any contraindication to progesterone or estrogen therapy Undiagnosed vaginal bleeding History of uterine fibroids or any other conditions that could adversely affect pregnancy success Hysterectomy Any contraindication to vaginal drug delivery systems

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: DR-2011<br>* Administered vaginally from Day 14 to Day 31<br>|
| Active Comparator: 2<br> | Drug: Progesterone 8% Vaginal Gel<br>* Administered vaginally from Cycle Day 14 to Day 31<br>* Other names: Crinone;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adequate endometrial transformation |  | Cycle Day 25 or 26 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hormone levels |  | Duration of study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
luteal phase replacement, oocyte donation, infertility, progesterone
Comparison of Stapler Line Bleeding Control Techniquessurgery

Study Overview
=================
Brief Summary
-----------------
Introduction RYGB surgeon; Have become increasingly morbid obesity treatment methods with improvements in minimally invasive surgery. Ensuring patient comfort and early return to life are the criteria that should be given priority in this treatment method.The purpose of this study; Emphasizing that the cautery technique of the stapler line bleeding control methods is as successful as the other methods.

Detailed Description
-----------------
The question of the availability of cautery in RYGB surgeons

Official Title
-----------------
Comparison of Stapler Line Bleeding Control Techniques in Laparoscopic Gastric Bypass

Conditions
-----------------
Obesity, Morbid

Intervention / Treatment
-----------------
* Other: Coutery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Morbid obese patients Exclusion Criteria: Cirrhotic patients, those under 18 years of age, additional intraabdominal surgeries during LRYGBP and those who had previously undergone obesity surgery (revision surgery)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: coutery<br>Stapler bloom will be stopped with cautery | Other: Coutery<br>* Stapler line bleeding control with coutery<br>|
| No Intervention: clips<br>Stapler bloom will be stopped with clipping | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-item drainage control | Bleeding quantities to be noted | 8 months |
A Study to Compare the Bioavailability of Copegus and Vilona® in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
This prospective, randomized, single-blind, cross-over study will compare the bioavailability of Copegus (ribavirin) administered as tablets and ribavirin administered as capsules in healthy volunteers. Volunteers will be randomized to receive a single dose of 400 mg of ribavirin either as a capsule or as tablets; after a washout phase volunteers will be crossed-over to the other treatment. The anticipated time on study treatment is 10 days.

Official Title
-----------------
Prospective, Randomized, Single-blind, Cross-over, Comparative Study for Establishing Comparative Bioavailability of Copegus vs Vilona® in Healthy Volunteers

Conditions
-----------------
Healthy Volunteer

Intervention / Treatment
-----------------
* Drug: ribavirin [Copegus]
* Drug: ribavirin [Vilona]


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult healthy volunteers, 18 to 55 years of age Clinically healthy as confirmed by medical history, physical examination, electrocardiogram, thorax teleradiography and routine clinical laboratory measurements Body mass index between 18 and 28 kg/m2 Negative testing for drugs of abuse Exclusion Criteria: History or presence of any clinically significant condition that might interfere with the pharmacokinetics of the study drugs Volunteers require co-medications during the study Exposure to agents known as inducers or inhibitors of hepatic enzymatic system within 30 days prior to study start Having taken any medication with a clearance period of over seven half-life before study start Hospitalization or significant illness 30 days before study start Having received a investigational drug within 90 days prior to study start

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

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ribavirin capsule arm<br> | Drug: ribavirin [Vilona]<br>* Single oral dose of a 400 mg capsule<br>|
| Experimental: Ribavirin tablet arm<br> | Drug: ribavirin [Copegus]<br>* Single oral dose of 400 mg tablets<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioavailability |  | 10 days |
XELOX for Metastatic Breast Cancer

Study Overview
=================
Brief Summary
-----------------
Both capecitabine and oxaliplatin have single agent activity in breast cancer. The combination has improved activity in other solid tumors. This study seeks to assess the activity of the combination in breast cancer.

Official Title
-----------------
A Phase II Trial of Capecitabine and Oxaliplatin in Metastatic Breast Cancer

Conditions
-----------------
Metastatic Breast Cancer

Intervention / Treatment
-----------------
* Drug: Capecitabine and Oxaliplatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: preserved organ function good performance status no more than one prior therapy no active brain metastasis Exclusion Criteria: No prior capecitabine or oxaliplatin no con-current therapy

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

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Capecitabine and Oxaliplatin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity |  |  | 
| Time to progression |  |  |
Phase I Pilot Study to Evaluate the Prognostic Value of Perfusion CT for Primary Cervical Cancer

Study Overview
=================
Brief Summary
-----------------
The investigators hope to learn whether perfusion CT is a useful way to assess primary cervical tumor microenvironment and whether there is a relationship between pretreatment perfusion CT measurements and primary cervical tumor size, lymph node involvement (as assessed by standard of care pretreatment fludeoxyglucose Positron emission tomography/CT (FDG-PET/CT)), and treatment response (as assessed by standard of care 3-month post-therapy FDG-PET/CT).

Official Title
-----------------
Phase I Pilot Study to Evaluate the Prognostic Value of Perfusion CT for Primary Cervical Cancer

Conditions
-----------------
Cervical Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: >18 years old with biopsy-proven squamous, adenocarcinoma or adenosquamous cervical cancer no history of prior pelvic radiation and should be able to receive chemoradiation non-pregnant women who have not previously undergone a hysterectomy, as that would have removed the cervix. able to give informed consent Exclusion criteria: Subjects whose tumors are not FDG avid on the pre-therapy PET. Allergy or inability to receive iodinated CT contrast

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 |
| --- | --- | --- |
| Measure perfusion in primary cervical tumors using perfusion CT. | Treatment response will be assessed using a post-treatment FDG-PET/CT to evaluate for complete response, persistent disease or new disease. The association between pre-treatment perfusion CT parameters and response on the post-treatment FDG-PET/CT will be analyzed. | 3-6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cervix Uteri
Study of Freeze-dried Black Raspberry in Maintenance of Ulcerative Colitis

Study Overview
=================
Brief Summary
-----------------
This research study is about adding Black Raspberry powder to the treatment regimen of patients with ulcerative colitis who are currently in remission and doing well.

Official Title
-----------------
A Trial of Freeze-dried Black Raspberry in Maintenance of Remission of Ulcerative Colitis

Conditions
-----------------
Ulcerative Colitis

Intervention / Treatment
-----------------
* Drug: Freeze-dried black raspberry powder


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients (>18 years of age) with known diagnosis of ulcerative colitis who are currently in remission on a stable dose of 5-ASA products and/or steroids (equivalent to prednisone 20 mg or less). English speaking/reading male or female patients from all ethnicities will be considered for the study. Exclusion Criteria: Treatment with Immunomodulators and/or biologic agents, active disease flare, patients younger than 18 years old, patients who are pregnant or trying to get pregnant, breast feeding and those with reported history of allergy or hypersensitivity to berry products. Patients who are using NSAIDS will also be excluded from the study but low dose ASA (81-162 mg) is permitted if needed.

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Black raspberry powder<br>Black raspberry powder 25 grams once daily for 4 weeks. If tolerated, will increase to 25 grams twice a day for another 20 weeks. Total length of active treatment 24 weeks. | Drug: Freeze-dried black raspberry powder<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Remission rate |  | 6 months |
Special Drug Use Investigation for AMERGE® Tablet (Long-term)

Study Overview
=================
Brief Summary
-----------------
To investigate the long-term safety and efficacy of AMERGE (naratriptan hydrochloride) on Japanese patients with migraine headache in clinical setting

Official Title
-----------------
Special Drug Use Investigation for AMERGE Tablet (Long-term)

Conditions
-----------------
Migraine Disorders

Intervention / Treatment
-----------------
* Drug: Naratriptan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must use AMERGE for the first time Exclusion Criteria: Patients with hypersensitivity to naratriptan or any of the components. Patients with history, symptoms, or signs of myocardial infarction, ischemic cardiac or angina inversa Patients with history of cerebral vascular disturbance or transient ischaemic attack Patients with peripheral vascular syndromes Patients with uncontrolled hypertension Patients with severe renal or hepatic impairment Patients using treatment with another 5-HT1 agonist, an ergotamine-containing or ergot-type medication
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients prescribed AMERGE<br>Patients with migraine disorders prescribed AMERGE during study period | Drug: Naratriptan<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of adverse drug reactions and serious adverse events |  | 6 months |
Effect of a Visual Nutrient Profiling System on Recall of Nutrition Information

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to validate a visual method of presenting nutritional information by determining if users of the visual method remember food properties better than users given the same information in a non-visual form with texts and tables.

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

Intervention / Treatment
-----------------
* Behavioral: Visual nutrient profiling tool
* Behavioral: Nutrient ratings table


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Current student at University of Illinois at Urbana-Champaign Exclusion Criteria: N/A

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Visual<br>Group provided with nutrition information using visual nutrient profiling tool | Behavioral: Visual nutrient profiling tool<br>* Shown color coded fiber and protein 2x2 plot, selected fiber and protein ratings from boxes on the plot.<br>|
| Other: Table<br>Group provided nutrition information using table format | Behavioral: Nutrient ratings table<br>* Showed nutrition information and had to match to fiber and protein ratings from a table.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of correct responses for fiber and protein ratings of foods | Fiber and protein ratings (5 possible) for 30 foods must be recalled after being presented in a visual or tabular format. Distraction period occurred between presentation of information and recall (maze). | 10 minutes after presentation of nutrition information | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Food labeling, Nutrition, Memory, Diet
Xalacom And Combination Of Unfixed Latanoprost And Timolol In Subjects With Open-Angle Glaucoma Or Ocular Hypertension

Study Overview
=================
Brief Summary
-----------------
to compare efficacy and safety of Xalacom with the combination of unfixed Latanoprost and Timolol in subjects with open-angel glaucoma or ocular hypertension

Official Title
-----------------
An 8-Week, Randomized, Open-Label, Parallel Group Study Comparing The Efficacy And Safety Of Xalacom With The Combination Of Unfixed Latanoprost And Timolol In Subjects With Open-Angle Glaucoma Or Ocular Hypertension

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

Intervention / Treatment
-----------------
* Drug: Xalacom
* Drug: unfixed Latanoprost and Timolol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with open-angle glaucoma or ocular hypertension Exclusion Criteria: closed/barely open anterior chamber angle or a history of acute angel closure glaucoma Ocular surgery within 3 months

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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Xalacom|nan|
|Drug: unfixed Latanoprost and Timolol|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To demonstrate that Xalacom is as effective as uFC latanoprost and timolol at reducing IOP in subjects with open-angel glaucoma or ocular hypertension |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the proportion of subjects reaching specified IOP levels at Week 8 To evaluate the ocular and systemic AEs across all clinic visits |  |  |
The Effect of Patients' Participation in Improving Diabetes Care

Study Overview
=================
Brief Summary
-----------------
Despite the advent of efficacious medicines, there is a gap between ideal and actual care in the achievement of recommended outcomes among diabetic patients. The study enrolled 429 diabetic patients attending four HMO clinics in Israel, two in the northern region and two in the southern region. All clinics were randomly selected from all clinics affiliated with the Faculty of Health Sciences of the Ben Gurion University. The objective of the study was to compare the effects of a multi-component physician-patient intervention to physician feedback alone on a combined outcome of diabetes, blood pressure and serum lipids control. We hypothesized that in medical practices where physicians have received feedback on quality of care indicators, patients who received a letter encouraging them to discuss a list of important diabetes-related issues with their doctors, would experience better outcomes compared to patients who did no received such a letter.

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

Intervention / Treatment
-----------------
* Behavioral: physician feedback (A)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Known diabetic patients enrolled in the four primary care clinics Age 30 years and older. Exclusion Criteria: Below age 30 years Type 1 diabetes Spoke neither Hebrew nor Russian Bedridden or confined to home.

Ages Eligible for Study
-----------------
Minimum Age: 30 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: B<br>Feedback to physicians + reminder letters to patients | Behavioral: physician feedback (A)<br>* Feedback information to physicians<br>|
| Active Comparator: A<br>Feedback information to physicians | Behavioral: physician feedback (A)<br>* Feedback information to physicians<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c, LDL, systolic blood pressure |  | Baseline and 1 year after 1-year intervention |