linjc16/ctgov huggingface dataset:
Direct Anterior Approach (DAA) for Total Hip Arthroplasty (THA): Capsular Resection Versus Capsular Flap Retention

Study Overview
=================
Brief Summary
-----------------
Direct Anterior Approach (DAA) for Total Hip Arthroplasty (THA): Capsular resection versus capsular flap retention. Prospective study design comparing clinical data in randomized THA patients who either had capsular resection or capsular flap retention.

Official Title
-----------------
Direct Anterior Approach (DAA) for Total Hip Arthroplasty (THA): Capsular Resection Versus Capsular Flap Retention

Conditions
-----------------
Coxarthritis

Intervention / Treatment
-----------------
* Procedure: Capsular resection
* Procedure: Capsular retention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: primary THA Exclusion Criteria: neurologic disease painful contralateral THA severe back or knee pain rheumatology
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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Capsular resection<br>Capsular resection | Procedure: Capsular resection<br>* Capsular resection<br>|
| Active Comparator: Capsular retention<br>Capsular retention | Procedure: Capsular retention<br>* Capsular retention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical data will be measured with scoring list HHS (Harris Hip Score). | Hypothesis: No clinical difference in DAA using capsular resection vs retention. Clinical outcomes will be measured with scoring list HHS (Harris Hip Score). | One year | 
| Clinical data will be measured with scoring list WOMAC (The Western Ontario and McMaster Universities Arthritis Index). | Hypothesis: No clinical difference in DAA using capsular resection vs retention. Clinical outcomes will be measured with scoring list WOMAC (The Western Ontario and McMaster Universities Arthritis Index). | One year | 
| Clinical data will be measured with scoring list UCLA (University of California Los Angles activity score). | Hypothesis: No clinical difference in DAA using capsular resection vs retention. Clinical outcomes will be measured with scoring list UCLA ((University of California Los Angles activity score). | One year | 
| Clinical data will be measured with scoring list HOOS (Hip dysfunction and Osteoarthritis Outcome Score). | Hypothesis: No clinical difference in DAA using capsular resection vs retention. Clinical outcomes will be measured with scoring lists HOOS (Hip dysfunction and Osteoarthritis Outcome Score). | One year |
Evaluation of Values in Perspective (VIP) Program

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to review and assess the usefulness of the Values in Perspective (VIP) program to avoid adolescent risky behaviors.

Official Title
-----------------
Evaluation of Values in Perspective (VIP) Program

Conditions
-----------------
Risk Behavior

Intervention / Treatment
-----------------
* Behavioral: VIP Program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria A youth residing in Miami-Dade County. Must be in grades 6-12 and must be eligible for free and reduced lunch. Must be able to speak and read English proficiently. Exclusion criteria Does not reside in Miami-Dade County. Does not comprehend, speak, or read English proficiently. In elementary school. In high-income household as evidenced by not qualifying for free and reduced lunch.

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 17 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VIP Program Group<br>Participants in this group will receive a 26 week course on risk reduction strategies. | Behavioral: VIP Program<br>* This intervention will engage the participants with psychoeducational material once a week. This material will include didactic instruction as well as participant engagement in developmentally appropriate activities.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SRAE Scores - Middle School | Sexual Risk Avoidance Education Program (SRAE) for middle school participants has a total score ranging from 0 to 170 with a higher score indicating higher risk behavior. | Up to 26 weeks | 
| SRAE Scores - High School | Sexual Risk Avoidance Education Program (SRAE) for high school participants has a total score ranging from 0 to 190 with a higher score indicating higher risk behavior. | Up to 26 weeks |
Clinical Effects of Large Segmental Bone Defects With 3D Printed Titanium Implant

Study Overview
=================
Brief Summary
-----------------
The investigators apply 3D printed titanium implant to treat bone defects. Without using bone grafts and growth factors, the investigators anticipate the titanium implant alone can help bone reconstruction.

Detailed Description
-----------------
The investigators treat large segmental bone defects caused by three reasons, including trauma, infection and tumor. In this study, polyporous 3D printed titanium implant is applied to reconstruct the bone defects and the investigators will follow up patients' function and bone regeneration.

Official Title
-----------------
Clinical Effects of Large Segmental Bone Defects Caused by Trauma, Infection and Tumor With 3D Printed Titanium Implant

Conditions
-----------------
Large Segmental Bone Defect

Intervention / Treatment
-----------------
* Device: 3D printed titanium implant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: bone defects caused by trauma or infection or tumor the length of bone defect is more than 6cm more than 18 years old Exclusion Criteria: malignant tumor patients with bad conditions failing to tolerate surgery

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: bone defects caused by trauma<br>Large bone defects (>6cm) caused by trauma | Device: 3D printed titanium implant<br>* The 3D printed titanium implant is fabricated by related companies. And some implants have been used in spinal disease in our hospital.<br>|
| Experimental: bone defects caused by infection<br>Large bone defects caused by chronic osteomyelitis | Device: 3D printed titanium implant<br>* The 3D printed titanium implant is fabricated by related companies. And some implants have been used in spinal disease in our hospital.<br>|
| Experimental: bone defects caused by tumor<br>Large bone defects caused by benign tumor | Device: 3D printed titanium implant<br>* The 3D printed titanium implant is fabricated by related companies. And some implants have been used in spinal disease in our hospital.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone reconstruction | X-rays and CT scans are used to evaluate the bone reconstruction | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Questionnaire of limb function | Restoration of limb function. | 1 year |
A Study of RO5190591 (Danoprevir) in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
This non-randomized, open-label study will evaluate the interaction of RO5190591(danoprevir)/ritonavir with and without ketoconazole and the safety and tolerability in healthy volunteers. Participants will be administered repeated daily doses of ketoconazole alone, RO5190591/ritonavir, and RO5190591/ritonavir plus ketoconazole. The anticipated time on study treatment is 25 days.

Official Title
-----------------
A Two-Way Interaction Study Between RO5190591/RTV and Ketoconazole in Healthy Subjects

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

Intervention / Treatment
-----------------
* Drug: danoprevir
* Drug: ketoconazole
* Drug: ritonavir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult healthy volunteers, aged 18-64 years, inclusively Weight >/=50.0 kg Body Mass Index (BMI) 18.0-32.0 kg/m2 Ability and willingness to abstain from alcohol, xanthine-containing beverages or food (coffee, tea, cola, chocolate, energy drinks) from 48 hours prior to entry in the clinical study center until discharge Ability and willingness to abstain from grapefruit or grapefruit juice, star fruit, and Seville oranges from 7 days prior to entry in the clinical study center until discharge Medical history without major recent or ongoing pathology Exclusion Criteria: Pregnant or lactating women and male partners of women who are pregnant or lactating Sustained supine systolic blood pressure >140 or <90 mmHG and supine diastolic blood pressure >90 or <50 mmHG at Screening or Day -1 Resting heart rate >100 or <45 beats per minute at Screening or Day -1 Any history of clinically significant cardiovascular or cerebrovascular disease Positive drug test result at screening or each admission Donation or loss of blood over 450 ml (1 pint) within 60 days prior to screening

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: danoprevir<br>* Repeated daily doses<br>Drug: ketoconazole<br>* Repeated daily doses<br>Drug: ritonavir<br>* Repeated daily doses<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate the interaction between RO5190591/ritonavir and ketoconazole |  | Day 40 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety and tolerability of multiple doses of RO5190591/ritonavir without and with ketoconazole |  | Day 40 |
Topical Vitamin B12 in Chronic Plaque Psoriasis

Study Overview
=================
Brief Summary
-----------------
Objective: To test the efficacy and tolerability of a vitamin B12 cream for the treatment of chronic plaque psoriasis. Design: Multicenter, double-blind, randomized, placebo-controlled trial.

Detailed Description
-----------------
Objective: To test the efficacy and tolerability of a vitamin B12 cream for the treatment of chronic plaque psoriasis. Design: Multicenter, double-blind, randomized, placebo-controlled trial. Setting: ambulatory patients in research or referral centers. Patients: Volunteer sample of 51 patients with chronic plaque psoriasis. Interventions: All Patients applied vitamin B12 cream twice daily for 8 weeks to one side of the body and placebo to the other. Main outcome measures: Modified Psoriasis Area and Severity Index (PASI) at weeks 0, 2, 4, 6 and 8. Thickness and density of 3 references plaques determined by 20 MHz sonography. Assessment of efficiency and tolerability by patients and investigators.

Official Title
-----------------
Topical Vitamin B12 in Chronic Plaque Psoriasis

Conditions
-----------------
Chronic Plaque Psoriasis

Intervention / Treatment
-----------------
* Drug: topical vitamin B12


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18years chronic plaque psoriasis Exclusion Criteria: incapability of Vitamin B12 necessity of systemic therapy use of other potentially psoriasis modifying drugs

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: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: topical vitamin B12|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Main outcome measures: Modified Psoriasis Area and Severity Index (PASI) at weeks 0, 2, 4, 6 and 8. Thickness and density of 3 references plaques determined by 20 MHz sonography. Assessment of efficiency and tolerability by patients and investigators. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
plaque psoriasis, Vitamin B12
Effect of Repaglinide and Metformin Combination Tablet or Rosiglitazone and Metformin in Fixed Dose Combination on Blood Glucose Control in Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in the United States of America (USA). This trial compares the changes in HbA1c after 26 weeks of repaglinide and metformin fixed dose combination tablet given as twice daily versus three times daily regimens or versus twice daily rosiglitazone and metformin fixed dose combination tablet in subjects with type 2 diabetes currently on monotherapy.

Official Title
-----------------
Repaglinide and Metformin Combination Tablet (NN4440) in a TID Regimen Compared to a BID Regimen and BID Avandamet in Subjects With Type 2 Diabetes: A Twenty-Six Week, Open-Label, Multicenter, Randomized, Parallel Group Trial to Investigate Efficacy and Safety

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

Intervention / Treatment
-----------------
* Drug: repaglinide and metformin combination tablet
* Drug: rosiglitazone and metformin combination tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes for at least 3 months HbA1c between 7.5-11.0% on monotherapy or HbA1c between 7.0-10.0% on dual therapy BMI maximum 45 kg/m2 Exclusion Criteria: Any clinically significant disease history in the opinion of the investigator Severe heart disease Pregnancy

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: repaglinide and metformin combination tablet|nan|
|Drug: rosiglitazone and metformin combination tablet|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | After 26 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 8-point Glucose Profiles |  |  | 
| Change in Lipid Profile |  |  | 
| Events of hypoglycemia |  |  | 
| Safety parameters |  |  | 
| Change in Fasting Plasma Glucose |  |  | 
| Waist/hip ratio change |  |  | 
| Change in body weight |  |  | 
| Percentage of subjects achieving sudden levels of HbA1c |  |  |
Electronic Triggers: Microhematuria Trigger

Study Overview
=================
Brief Summary
-----------------
The research team will evaluate the effectiveness of an InBasket Results message that prompts providers to place appropriate follow up orders.

Detailed Description
-----------------
The research team will evaluate the effectiveness of an InBasket Results message that prompts providers to place appropriate follow up orders. The message will notify users that a patient has clinically significant microscopic hematuria and is at high risk for underlying malignancy and will include the official recommendations (imaging with a CT urogram, urology evaluation with cystoscopy).

Official Title
-----------------
Electronic Trigger for Microhematuria

Conditions
-----------------
Hematuria

Intervention / Treatment
-----------------
* Other: Electronic Trigger Microhematuria Alert


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 35 years of age or older 3+ RBC on Urinalysis Urinalysis sent during an outpatient encounter any of the following: 60 years of age or older; RBC > 25; current or prior tobacco use; Gross Hematuria Exclusion Criteria: Under 35 years of age Cystoscopy within 1 year prior to Urinalysis Nitrite positive AND Leukocyte Esterase positive Nitrite positive AND >100 WBC Leukocyte Esterase positive AND >100 WBC Know GU cancer diagnosis Urinalysis ordered by urology provider

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>The group which will receive the InBasket message to notify users that a patient has clinically significant microscopic hematuria and makes recommendations for follow-up. | Other: Electronic Trigger Microhematuria Alert<br>* To evaluate the effectiveness of an InBasket Results message in prompting providers to place appropriate follow up orders. The message will notify users that a patient has clinically significant microscopic hematuria and is at high risk for underlying malignancy and will include the official recommendations (imaging with a CT urogram, urology evaluation with cystoscopy).<br>|
| No Intervention: Control<br>The group which will not receive the InBasket message to notify users that a patient has clinically significant microscopic hematuria. (Standard practice) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation rate | Urology evaluation with cystoscopy and appropriate imaging | 180 days of alert |
A Multicenter Expanded Access Treatment Protocol of Lurbinectedin in Previously Treated SCLC in the USA

Study Overview
=================
Brief Summary
-----------------
This is an expanded access program in the USA to enable eligible patients with previously treated small cell lung cancer to access lurbinectedin treatment prior to FDA approval. Sites must apply to participate in the program. A medical doctor must assess whether the potential benefit outweighs the risk of the investigational therapy considering the program eligibility criteria and the individual patient's medical history.

Official Title
-----------------
A Multicenter Expanded Access Treatment Protocol of Lurbinectedin (PM01183) in Previously Treated Small Cell Lung Cancer in the USA

Conditions
-----------------
Small Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: Lurbinectedin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Legally competent adult Confirmed and unresectable Small Cell Lung Cancer (SCLC) Patients must have received one prior chemotherapy containing line Adequate organ, hematological, kidney, metabolic and liver function Recovery from toxicities related to previous treatment(s) Pregnancy must be excluded, medically acceptable contraception method Exclusion Criteria: Prior treatment with lurbinectedin Certain concomitant diseases/conditions Symptomatic, steroid-requiring or progressive CNS involvement. Pregnant or breast-feeding women.

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Lurbinectedin|Powder for concentrate for solution for infusion in 4 mg vials|

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

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