linjc16/ctgov huggingface dataset:
Effect of Duolac 7S Administration on Improving Symptom in Irritable Bowel Syndrome

Study Overview
=================
Brief Summary
-----------------
Gut microflora-mucosal interactions may be involved in the pathogenesis of irritable bowel syndrome (IBS). The purpose of this study is to investigate the efficacy of Duolac7S in changing the colonic microflora and improve the symptoms in IBS sufferers. In all, 64 patients with Rome III positive diarrhea type IBS will complete a 6-week multiple centre controlled clinical trial. Patients will be randomized to receive either 2 capsules/day Duolac7S or 2 capsules/day placebo. IBS symptoms will be monitored and scored according to Likert scale. Changes in faecal microflora, stool frequency and form, quality of life (QOL) scores will be also monitored.

Conditions
-----------------
Irritable Bowel Syndrome

Intervention / Treatment
-----------------
* Dietary Supplement: Duolac7S
* Dietary Supplement: starch


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age: 18 65 years diarrhea type irritable bowel syndrome (by ROME III criteria) no organic bowel disease (by colonoscopy or barium enema) Exclusion Criteria: pregnant women or nursing mothers hypersensitivity to probiotics congestive heart failure or ischemic heart disease systolic blood pressure : more than 160 mmHg or diastolic blood pressure: more than 100 mmHg uncontrolled diabetes mellitus, secondary dyslipidemia, hyperthyroidism, or hypothyroidism abdominal surgery (exception: appendectomy, hernia surgery) more than moderate alcohol drinking

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Duolac 7S<br> | Dietary Supplement: Duolac7S<br>* 1 capsule two times everyday for 6 weeks<br>|
| Placebo Comparator: starch capsule<br> | Dietary Supplement: starch<br>* 1capsule two times everyday for 6 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The improvement of IBS symptoms | IBS symptoms were recorded on diary cards every evening during the treatment periods. Abdominal pain, discomfort,urgency and bloating were recorded (score 0-10); stool frequency as number of stools per day; stool consistency according to Bristol stool scale form (score 1-7). | 6 weeks (symptom diary and weekly questionnaire) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in fecal microflora |  | baseline and after 6weeks | 
| Changes of biochemical marker |  | baseline and after 6weeks |
Pain and Hysteroscopy

Study Overview
=================
Brief Summary
-----------------
The purpose of this research is to look at the impact that phrases of likely discomfort or a description of the procedure have on the perception of pain during in-office hysteroscopy.

Official Title
-----------------
Choose Your Words Wisely: Impact of a Provider's Language on Perceived Pain During Office Hysteroscopy: A Randomized Controlled Trial

Conditions
-----------------
Hysteroscopy Surgery

Intervention / Treatment
-----------------
* Other: Anticipated Discomfort Language
* Other: Objective Descriptive Language


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults 18 years of age and older Scheduled for in office hysteroscopy Able to consent for the study in English or Spanish Exclusion Criteria: Persons with preexisting conditions that may alter pain perception (ie. active vulvo-vaginal infection, vulvodynia, genital lesions, chronic pain conditions) Previous in-office hysteroscopy Hysteroscopy for foreign body/ Intrauterine Device (IUD) removal Minors, prisoners, or other members of vulnerable populations Patients who cannot communicate in English or Spanish

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Anticipated Discomfort Group<br>Participants will be prompted using anticipated discomfort language during the standard of care hysteroscopy. | Other: Anticipated Discomfort Language<br>* This language involves pain descriptors provided from physician to patient during procedure.<br>|
| Other: Objective Description Group<br>Participants will be prompted using objective description language during the standard of care hysteroscopy. | Other: Objective Descriptive Language<br>* This language involves neutral/objective descriptors provided from physician to patients during procedure.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pain as measured by Visual Analog Scale (VAS) | Pain will be assessed using the Visual Analog Scale (VAS). Visual Analog Scale (VAS) is score from 0 (no pain) to 10 (worst pain imaginable). | Baseline (pre-procedure), Day 1 (post-procedure) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants in each pain category | Number of participants reporting actual pain compared to their anticipated the pain post procedure. Pain Free Less painful than anticipated As painful as anticipated More painful than anticipated Much more painful than anticipated | Day 1 (post-procedure) |
the Effect of Isosorbide Mononitrate in Reducing Pain During Cooper Intrauterine Device Insertion

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate the efficacy of isosorbide mononitrate vaginal administration in reducing pain during copper IUD insertion in nulliparous women

Official Title
-----------------
the Effect of Vaginal Isosorbide Mononitrate Administration in Reducing Pain During Cooper Intrauterine Device Insertion in Nulliparous Women : a Randomized Controlled Trial

Conditions
-----------------
IUD Insertion Pain

Intervention / Treatment
-----------------
* Drug: Isosorbide mononitrate
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: nulliparous women requesting copper IUD device insertion Exclusion Criteria: parous women, contraindications to IUD insertion, allergy or contraindication to isosorbide mononitrate, uterine anomaly
Sexes Eligible for Study
-----------------
Female

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: Isosorbide Mononitrate<br>one tablet of Isosorbide Mononitrate (40 mg) vaginally 3 hours prior to copper IUD insertion | Drug: Isosorbide mononitrate<br>* one tablet of Isosorbide Mononitrate (40 mg) vaginally 3 hours prior to copper IUD insertion<br>|
| Placebo Comparator: placebo<br>one tablet of placebo vaginally 3 hours prior to copper IUD insertion | Drug: placebo<br>* one tablet of placebo vaginally 3 hours prior to copper IUD insertion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain during IUD insertion | intensity of patient-perceived pain at time of IUD insertion, using a visual analog scale. The VAS scale is graded from 0 to 100 on a 100 mm horizontal straight line, where 'zero' corresponds to no pain at all, and '100' to the worst possible pain imaginable. | 5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of IUD insertion | duration of IUD insertion from speculum in to speculum out | 5 minutes |
Prophylactic Intravesical Chemotherapy to Prevent Bladder Tumors After Nephroureterectomy for Primary Upper Urinary Tract Urothelial Carcinomas

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy of prophylactic intravesical chemotherapy (different chemotherapy drugs and dosage regimen) in the prevention of bladder recurrence after nephroureterectomy for upper tract urothelial carcinoma (UTUC).

Conditions
-----------------
Upper Tract Urothelial Carcinoma, Bladder Recurrence

Intervention / Treatment
-----------------
* Drug: pharmorubicin or pirarubicin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who were clinically diagnosed with UTUC Treated with radical nephroureterectomy Exclusion Criteria: Distant metastasis Prior history of bladder or synchronous bladder cancer Administration of neoadjuvant chemotherapy Presence of severe complications.
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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Blank control<br>do not use prophylactic intravesical chemotherapy | |
| Experimental: single intravesical instillation<br>intravesical instillation within 24 hours postoperatively | Drug: pharmorubicin or pirarubicin<br>* pharmorubicin 50mg pirarubicin 30mg<br>|
| Experimental: multiple intravesical instillation<br>intravesical instillation every 1 week for the first 2 months, then once a month for the rest 10 months | Drug: pharmorubicin or pirarubicin<br>* pharmorubicin 50mg pirarubicin 30mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intravesical recurrence-free survival |  | two years after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cancer-specific survival |  | two years after surgery |
Imaging Modalities for Pancreatic Collections

Study Overview
=================
Brief Summary
-----------------
The purpose of this project is to provide appropriate administrative and technical supports for the warehousing and use of imaging data in pancreatic necrosis data for research purposes.

Detailed Description
-----------------
The aim of this study is to create a prospective registry of patients with pancreatic collections and their imaging studies (including CT, MRI, EUS, and direct endoscopic visualization) to compare these techniques, develop standardized methods for analyzing these imaging studies, and use this information to enhance management of patients with pancreatic collections. There is very limited published literature on these peripancreatic lesions that compares all three of these modalities and thus we aim to study it in detail.

Official Title
-----------------
Comparative Registry of Structural Features of Pancreatic Collections Found on Cross Sectional Imaging

Conditions
-----------------
Pancreas Necrosis

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who are known to have a pancreatic fluid collection after an episode of acute pancreatitis age greater than 18 years Exclusion Criteria: pregnant woman age <18 years prisoners other institutionalized individuals patients who are decisionally impaired

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

| Intervention/Treatment |
| --- |
|Diagnostic Test: Endoscopy|Purpose of this study is to create a prospective registry of patients with pancreatic collections and their imaging studies|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to define severity of pancreatitis as mild, moderate, severe; based on amount of debris in the pancreatic lesion (mild: < 30% debris, moderate: 30-50% debris, severe: >50% debris) | Pancreatic lesions will be evaluated using CT, MRI, EUS, endoscopy to assess for severeity based on amount of debris in the pancreatic lesion | one year |
Urokinase Versus Primary Video-Assisted Thorascopic Surgery for Empyema

Study Overview
=================
Brief Summary
-----------------
This study will compare VATS versus chest drain insertion and urokinase in the treatment of childhood empema by a randomised prospective study.

Conditions
-----------------
Empyema

Intervention / Treatment
-----------------
* Drug: insertion of a chest drain with urokinase instillation
* Procedure: primary video-assisted thorascopic surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients under the age of 16 referred to GOSH for management of empyema Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 16 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: insertion of a chest drain with urokinase instillation|nan|
|Procedure: primary video-assisted thorascopic surgery|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| length of hospital stay |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| radiological changes at follow up |  |  |
Trial of a Novel Fibrinolytic (Alfimeprase) to Clear Thrombosed Vascular Access Devices

Study Overview
=================
Brief Summary
-----------------
This trial is for patients with a central venous catheter (a vascular access device) that is not functioning properly (unable to withdraw blood). The trial compares a new blood clot dissolving agent (alfimeprase) against the currently used treatment.

Official Title
-----------------
A Phase 2, Multicenter, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Alfimeprase for Restoring Function in Occluded Central Venous Catheters

Conditions
-----------------
Catheters, Indwelling

Intervention / Treatment
-----------------
* Drug: Alfimeprase


Participation Criteria
=================
Eligibility Criteria
-----------------
Subjects must: have a dysfunctional Central Venous Access Device (CVAD) defined as unable to withdraw 3 mL blood have had the device in place for > 48 hours be clinically stable be 18 or older give informed consent

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: Alfimeprase|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
-----------------
central venous access device, thrombosis, central venous catheter, thrombolysis, fibrinolysis
A Study of Two Approved Drugs in the Treatment of Post-Bunionectomy Surgery Pain (0966-234)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
This purpose of this study is to compare the safety and effectiveness of two approved drugs in the treatment of pain following bunionectomy surgery.

Detailed Description
-----------------
The duration of treatment is 5 days for rofecoxib and 1 day for diclofenac sodium.

Official Title
-----------------
A Randomized, Double-Blind, Placebo- and Active-Comparator-Controlled, Parallel-Group Study of Rofecoxib and Diclofenac Sodium in the Treatment of Post-Bunionectomy Surgery Pain

Conditions
-----------------
Postoperative Pain

Intervention / Treatment
-----------------
* Drug: MK0966, rofecoxib
* Drug: Comparator: diclofenac sodium, placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Bunion removal Exclusion Criteria: Any known allergies to the study design

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: MK0966, rofecoxib|nan|
|Drug: Comparator: diclofenac sodium, placebo|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall analgesic effect over 8 hours |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to onset of analgesic effect. |  |  | 
| The use of supplemental analgesia on Days 2-3. |  |  | 
| Peak analgesic effect on Day 1. |  |  | 
| Overall safety and tolerability. |  |  | 
| The analgesic effect on Days 2-3. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bunionectomy
The Effects of Radial and Focused Extracorporeal Shock Wave Therapies on Lateral Epicondylitis

Study Overview
=================
Brief Summary
-----------------
To date, focused and radial types of extracorporeal shock wave therapy have been effectively used in lateral epicondylitis. However, studies directly addressing a comparison between radial and focused types of extracorporeal shock wave therapy in lateral epicondylitis have not been done. Therefore, this study aims to evaluate comparative effects of radial and focused extracorporeal shock wave therapy options on lateral epicondylitis.

Official Title
-----------------
Comparative Effects of Radial and Focused Extracorporeal Shock Wave Therapies on Lateral Epicondylitis: A Randomised Sham-controlled Trial

Conditions
-----------------
Lateral Epicondylitis, Pain

Intervention / Treatment
-----------------
* Device: Extracorporeal shock wave


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of lateral epicondylitis be aged ≥18 at the time of diagnosis be give informed consent Exclusion Criteria: be have not completed the assessment process. elbow deformity psychological illness

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Focus ESWT<br> | Device: Extracorporeal shock wave<br>* Focus and Radial types Extracorporeal shock wave therapy<br>|
| Active Comparator: Radial ESWT<br> | Device: Extracorporeal shock wave<br>* Focus and Radial types Extracorporeal shock wave therapy<br>|
| Sham Comparator: Sham ESWT<br> | Device: Extracorporeal shock wave<br>* Focus and Radial types Extracorporeal shock wave therapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale | pain evaluation, higher scores mean a worse outcome. | 1 min. | 
| Patient-Rated Tennis Elbow Evaluation | Scale, Higher scores represent higher level of pain and disability. | 5 min. |
Long Term Follow-Up of HIV Infected Patients Who Have Previously Participated in HIV Clinical Trials

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to monitor the progression of HIV infection and HIV-related disease processes in patients who have previously participated in HIV clinical trials.

Detailed Description
-----------------
Since 1982, the National Institute of Allergy and Infectious Diseases (NIAID) has been conducting numerous clinical trials on patients infected with HIV-1. Unfortunately, once clinical studies have closed or participants have reached a study endpoint, no additional follow-up data are collected regarding progression of HIV infection and development of HIV-related complications in these study participants. This study will collect long-term data for participants of previous NIAID-sponsored clinical trials to study HIV-related disease processes and complications, benefits and toxicities of investigational medications and vaccines, and medical management of participants with known or suspected HIV infection. Study visits will occur every 6 months. A physical exam, blood collection, and medical history will occur at all visits. Depending on the need of participants, additional laboratory and diagnostic tests will be performed, and standard medical care will be provided.

Official Title
-----------------
Clinical, Virologic, and Immunologic Evaluation and Monitoring of Patients With Known or Suspected HIV Infection

Conditions
-----------------
HIV Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV infected Previously participated in a NIAID-funded clinical trial studying HIV 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?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

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