linjc16/ctgov huggingface dataset:
Safety and Efficacy Study for a New Antiviral Drug to Treat Genital Herpes Type 2

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to find out whether AIC316 is safe and efficacious for the prevention of reactivation of genital herpes

Official Title
-----------------
A Double-blind Randomized Placebo Controlled Dose-finding Trial to Investigate Different Doses of a New Antiviral Drug in Subjects With Genital HSV Type 2 Infection

Conditions
-----------------
HSV-2

Intervention / Treatment
-----------------
* Drug: AIC316
* Drug: AIC316
* Drug: AIC316
* Drug: AIC316
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult, Immunocompetent men and women in good health of any ethnic group History of recurrent episodes of genital herpes for at least 12 months Seropositive for Herpes Simplex Virus HSV Type 2 Body Mass Index (BMI) between 18 and 35 kg/m2 Exclusion Criteria: Present episode of genital herpes Intake of systemic drug against HSV or any topical application against HSV within 7 days before randomization for the trial Intake of systemic corticosteroids, other immunomodulating agents or any investigational agent within 3 months before randomization for the trial Positive results in any of the virology tests for human immunodeficiency virus antibody (HIV-Ab), hepatitis C antibody (HCV-Ab), hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBc-Ab)

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose regimen 1<br> | Drug: AIC316<br>* Oral administration<br>* Other names: pritelivir;|
| Experimental: Dose regimen 2<br> | Drug: AIC316<br>* Oral administration<br>* Other names: pritelivir;|
| Experimental: Dose regimen 3<br> | Drug: AIC316<br>* Oral administration<br>* Other names: pritelivir;|
| Experimental: Dose regimen 4<br> | Drug: AIC316<br>* Oral administration<br>* Other names: pritelivir;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Oral administration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of 4 Different Doses of AIC316 and Matching Placebo With Respect to the Suppression of Herpes Simplex Virus Replication (Shedding Rate) | Subjects were assessed for shedding rate as the percentage of number of swab days with at least one swab positive for HSV DNA relative to the total number of days with analyzable swabs. Measurement was based on presence of HSV DNA measured on the material collected from swabs taken at the visits by the investigator and daily swabbing of the anogenital region by the patient during the treatment and post-treatment period. | 28 days |
Montelukast in Pediatric Patients Aged 6 to 24 Months With Asthma--Safety Study (0476-176)

Study Overview
=================
Brief Summary
-----------------
A study of Montelukast compared to placebo in asthmatic children aged 6-24 months.

Official Title
-----------------
A Multicenter, Double-Blind, Randomized, Parallel-Group Study Comparing Montelukast With Placebo in Pediatric Patients Aged 6 to 24 Months With Asthma

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: montelukast sodium
* Drug: Comparator: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is in good, stable health Patient has been fed solid foods for at least 1 month Patients had at least 3 episodes of asthma or asthma-like symptoms, all occurring after 8 weeks of age; at least one within 6 months of the Prestudy Visit Patients had to be in need of a controller therapy according to criteria established in the Global Initiative for Asthma (GINA) guidelines Exclusion Criteria: Patient was hospitalized at the start of the study or required a visit to the emergency room due to asthma with in past 2 weeks

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 24 Months

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Montelukast | Drug: montelukast sodium<br>* Montelukast 4-mg oral granules mixed with applesauce once daily at bedtime for 6 weeks<br>|
| Placebo Comparator: 2<br>Placebo | Drug: Comparator: Placebo<br>* Placebo oral granules mixed with applesauce once daily at bedtime for 6 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Clinical Adverse Experiences (CAEs) Reported by Patients During the 6-weeks of Treatment | An adverse experience (AE) is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR'S product, whether or not considered related to the use of the product | During the 6 weeks of treatment |
Assessment of Small Bowel Healing in Crohn's Disease Patients Treated With Cimzia Using Wireless Capsule Endoscopy

Study Overview
=================
Brief Summary
-----------------
Wireless Capsule Endoscopy has been the most reliable diagnostic standard for small bowel Crohn's disease. Endoscopic healing is an important endpoint to measure response to treatment.

Official Title
-----------------
Open Label Investigator Initiated, Single Site Study of Mucosal Healing in Patients With Small Bowel Crohn's Disease Treated With Certolizumab Pegol (Cimzia) Assessed by Wireless Capsule Endoscopy

Conditions
-----------------
Crohn's Disease

Intervention / Treatment
-----------------
* Drug: certolizumab pegol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults aged 18-70 with confirmed Crohn's disease that includes small bowel disease Moderately to severely active disease (CDAI score >220 and < 450) Stable doses of steroids, 5-ASA, antibiotics, Immunosuppressants Exclusion Criteria: Any and all contraindications to the use of certolizumab pegol (including but not limited to hepatitis, infection, abscess, malignancy, congestive heart failure [CHF], cytopenia) Small bowel obstruction, stricture, or any contraindication for capsule endoscopy Previous treatment with certolizumab pegol Are pregnant or lactating

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: certolizumab pegol<br>Subjects will receive FDA approved Cimzia injections as indicated on the product label. Subjects will undergo 3 wireless capsule endoscopies, one at screening,Day 84 and Day 168 as well as monthly bloodwork. | Drug: certolizumab pegol<br>* 400mg subcutaneous injections at week 0, week 2, week 4, then every 4 weeks thereafter<br>* Other names: Cimzia;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mucosal Healing |  | 180 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C-Reactive Protein (CRP) Level |  | 180 Days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Crohn's, Inflammatory Bowel Disease
Reducing Opioid Prescription After Kidney Stone Removal Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to implement and assess a standard way of prescribing opioid pain medication following PCNL (a kidney stone removal surgery) to ensure patients are being discharged with an appropriate quantity of pain management medication.

Detailed Description
-----------------
Participants in this study will have their opioid pain medication prescription at discharge following PCNL (Percutaneous Nephrolithotomy, a kidney stone removal surgery) determined by an algorithm in addition to physician judgement. The goal of the algorithm is help physicians refine pain medication prescribing patterns for patients who have undergone PCNL in order to discharge patients with an appropriate quantity of pain management medication. The effectiveness of the algorithm will be assessed through participant surveys. Participants will complete a brief online survey on Days 3, 7, and 14 following hospital discharge and another phone-based survey 26-30 days after hospital discharge.

Official Title
-----------------
Reducing Opioids After Percutaneous Stone Surgery

Conditions
-----------------
Kidney Stone

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Patients undergoing percutaneous nephrolithotomy at Mayo Clinic Rochester. Exclusion Criteria: Unable or unwilling to provide informed consent. Patients who require Intensive Care Unit admission after surgery. Patients who have Clavien grade III or greater postoperative complications requiring additional intervention < 30 days after index procedure.

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 |
| --- | --- | --- |
| Unused opioid prescriptions | Number of unused opioids following recovery from percutaneous nephrolithotomy | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Unfilled opioid prescriptions | Number of unfilled opioid prescriptions following recovery from percutaneous nephrolithotomy | 30 days | 
| Opioid prescription refills | Number of opioid prescription refills following recovery from percutaneous nephrolithotomy | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Percutaneous Nephrolithotomy (PCNL)
Type 2 Diabetes Controlled Eating Experiment

Study Overview
=================
Brief Summary
-----------------
A short-term feeding study in type 2 diabetics manipulating the fat and caloric values of meals to assess both compensation and glucose control, both covertly and overtly.

Official Title
-----------------
Use of Modified Foods in the Dietary Treatment of Type II Diabetes Mellitus: Short Term Feeding Study

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

Intervention / Treatment
-----------------
* Behavioral: covert v overt nutrition labeling
* Behavioral: varying meal nutrition manipulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: type 2 diabetic, age 18+, informed consent, able to eat 3 meals/day 1 day/week at clinic Exclusion Criteria: non-diabetic, type 1 diabetic

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: Educational/Counseling/Training
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: covert v overt nutrition labeling|nan|
|Behavioral: varying meal nutrition manipulation|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| glucose control |  |  | 
| caloric compensation |  |  |
2 Doses of an Approved Drug Being Studied for a New Indication for the Prevention of Postoperative Nausea and Vomiting (0869-091)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety and efficacy of 2 doses of an approved drug for a new indication in the prevention of postoperative nausea and vomiting in patients receiving general anesthesia for open abdominal surgery requiring overnight hospital stay.

Detailed Description
-----------------
The duration of treatment is 4 weeks.

Official Title
-----------------
A Randomized, Double-Blind, Active Comparator-Controlled, Parallel-Group Study, Conducted Under In-House Blinding Conditions, to Examine the Safety, Tolerability, and Efficacy of 2 Doses of Aprepitant for the Prevention of Postoperative Nausea and Vomiting

Conditions
-----------------
Postoperative Nausea and Vomiting

Intervention / Treatment
-----------------
* Drug: MK0869, aprepitant
* Drug: Comparator: ondansetron IV


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is at least 18 years of age. Patient is scheduled to undergo open abdominal surgery requiring overnight hospital stay (24-hour hospital stay after end of surgery). Patient is scheduled to receive general anesthesia. Patient is scheduled to receive postoperative opioids.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0869, aprepitant|nan|
|Drug: Comparator: ondansetron IV|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevention of PONV in the 24 hours following end of surgery; Tolerability |  | 24 hours |
Diagnostic Accuracy of Body Temperature Measurement in Geriatric Patients

Study Overview
=================
Brief Summary
-----------------
Retrospective analysis of a quality measurement project examining the quality of vital parameter measurement in consecutive patients >= 75 years presenting to the emergency department. Primary goal of the study is to evaluate the diagnostic accuracy of body temperature measurement using different methods to diagnose infection in patients >= 75 years presenting to the emergency department. The secondary goal is to compare the reliability of tympanal and temporal artery thermometry with rectal temperature measurement.

Official Title
-----------------
Diagnostic Accuracy of Body Temperature Measurement in Geriatric Patients Presenting to the Emergency Department

Conditions
-----------------
Fever, Infection

Intervention / Treatment
-----------------
* Other: rectal, tympanal and temporal artery thermometry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >= 75 years given informed consent Exclusion Criteria: patients who do not speak the German language patients with unstable cardiorespiratory status presence of contraindications to one of the temperature measurement methods

Ages Eligible for Study
-----------------
Minimum Age: 75 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 |
| --- | --- |
| Geriatric patients ED<br>Consecutive patients >= 75 years in the emergency department. | Other: rectal, tympanal and temporal artery thermometry<br>* Temperature measurement was done once in all patients included within the first hour of patients´presentation to the emergency department. Tympanal measurement was carried out by the use of infrared ear thermometry, temporal artery thermometry was done using infrared technology as well.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy of rectal, tympanal and temporal artery thermometry to diagnose infection | The primary outcome measure is the diagnostic accuracy of rectal, tympanal and temporal artery thermometry to diagnose infection in old patients presenting to the ED | June 2012 |
AIDS Wasting in Women: Anabolic Effects of Testosterone

Study Overview
=================
Brief Summary
-----------------
The study is a 6 month, placebo-controlled study of transdermal testosterone for women with HIV-associated weight loss. Women with AIDS wasting have been found to have low testosterone levels. This study is designed to test the efficacy of physiologic testosterone dosing to improve weight, muscle mass and quality of life indices, including energy level, appetite and libido, in androgen deficient women with AIDS wasting. After 6 months, all women receive open label transdermal testosterone for an additional 6 months.

Conditions
-----------------
AIDS Wasting Syndrome

Intervention / Treatment
-----------------
* Drug: Testosterone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Females using acceptable form of birth control during study, including barrier contraception or IUD but excluding oral contraceptives or Depo-Provera Documented HIV infection Free testosterone level 3.0 pg/mL Weight < 90% or weight loss > 10% of pre-illness weight Exclusion Criteria: Pregnant or actively seeking pregnancy Breast feeding New opportunistic infection diagnosed within 4 weeks of the study Requiring parenteral nutrition or pharmacologic glucocorticoid therapy Intractable diarrhea (6 stools/day) Androgen, estrogen, progestational derivative, or glucocorticoid administration within 3 months of the study, including Megace New retroviral therapy within 6 weeks of study SGOT > 5 X normal and/or clinically significant liver disease Creatinine > 2.0 mg/dL and/or clinically significant renal disease Hgb < 8.0 g/dL Active substance abuse or alcoholism

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Testosterone|nan|

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
-----------------
AIDS, HIV, weight loss, Wasting Syndrome, testosterone, androgen levels, hormones
Pneumatic Dilatation or Surgical Myotomy for Achalasia

Study Overview
=================
Brief Summary
-----------------
Patients with newly diagnosed achalasia have been submitted to either treatment with pneumatic dilatation or surgical myotomy. Minimal follow up five years.

Detailed Description
-----------------
Patients with newly diagnosed achalasia have been submitted to either treatment with pneumatic dilatation or surgical myotomy. Minimal follow up five years. During follow up patients have been interviewed with regular intervals, by use validated questionnaires. The level of symptom control has been assessed as well as the scoring cumulative incidence of treatment failures. Health Related Quality of Life (HRQL) has been regularly checked.

Official Title
-----------------
Randomized Study to Compare Pneumatic Dilatation With Surgical Myotomy for Treatment of Achalasia - Long Term Follow up

Conditions
-----------------
Achalasia

Intervention / Treatment
-----------------
* Procedure: Pneumatic dilatation
* Procedure: Laparoscopic myotomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newly diagnosed achalasia Age 18-80 years Informed consent Exclusion Criteria: Previous treatment for achalasia. Stage IV achalasia. Unwillingness to participate.

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pneumatic dilatation<br>Repetitive pneumatic dilatation as the initial treatment followed by repetitive dilatation in case of dysphagia recurrence. | Procedure: Pneumatic dilatation<br> <br> |
| Active Comparator: Surgical myotomy<br>Laparoscopic myotomy and subsequent follow up. | Procedure: Laparoscopic myotomy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment failures | Treatment failure is defined as a Composite variabel containing a number of different Clinically relevant outcomes. | At least five years after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dysphagia scoring | Dysphagia score according to standardized, validated scoring system. | At least five years after intervention | 
| Health Related Quality of Life | Universally adopted and validated instruments are used. | At least five years after intervention. | 
| Direct medical costs. | Charges for the average hospital in respective countries. | At least five years after intervention. |