linjc16/ctgov huggingface dataset:
Dose Ranging Study Comparing the Efficacy, Safety and Pharmacokinetics of Intravenous Infusions of ABT-874 vs Placebo in Subjects With Active Crohn's Disease

Study Overview
=================
Brief Summary
-----------------
To compare the efficacy, safety and pharmacokinetics of ABT-874 to placebo in subjects who have moderately to severely active Crohn's Disease.

Official Title
-----------------
A Phase 2B, Multi-Center, Randomized, Double-blind, Parallel Group, Placebo-controlled, Dose Ranging Study Comparing the Efficacy, Safety and Pharmacokinetics of Intravenous Infusions of ABT-874 vs. Placebo in Subjects With Moderately to Severely Active Crohn's Disease.

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

Intervention / Treatment
-----------------
* Biological: Placebo
* Biological: ABT-874
* Biological: ABT-874


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Crohn's disease for greater than 4 months confirmed by endoscopy or radiologic evaluation. CDAI score of >= 220 and <= 450 at Week 0. Males and females >= 18 years and < 75 years of age at the Screening visit. Judged to be in generally good health as determined by the Investigator. Exclusion Criteria: Current diagnosis of the colitis other than Crohn's disease. Symptomatic known strictures. Surgical bowel resections within the past 6 months or is planning any resection at any time point while enrolled in the study. Ostomy or ileoanal pouch. (Subjects with a previous ileo-rectal anastomosis are not excluded). Short bowel syndrome as determined by the investigator. Infection or risk factors for severe infections. Females who are pregnant or considering becoming pregnant during the study, or breast-feeding.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 74 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br> | Biological: Placebo<br>* every 4 weeks, IV<br>|
| Experimental: 400 mg<br> | Biological: ABT-874<br>* 400 mg IV every 4 weeks<br>|
| Experimental: 700mg<br> | Biological: ABT-874<br>* 700 mg IV every 4 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects achieving clinical remission, defined as CDAI score of <150 points |  | Week 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient reported outcomes, clinical response indicators, safety parameters |  | Weeks 12 and 24 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Crohn's Disease
Effects of Training in Healthy Sedentary Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to understand underlying mechanisms of improved exercise tolerance in Healthy Sedentary Subjects after training program.

Detailed Description
-----------------
Training protocol used is based on recommendations. A minimum of 20 sessions in 4-6 weeks were proposed. The exercise intensity of exercise corresponds to target heart rate at ventilatory threshold measured during incremental exercise test. Training at this intensity allowed us to individualize effort for each patient.

Official Title
-----------------
Cellular Effects of Training in Healthy Sedentary Subjects

Conditions
-----------------
Sedentary Subjects

Intervention / Treatment
-----------------
* Other: Training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy Sedentary Subjects Exclusion Criteria: neuromuscular disease chronic heart failure diabetes renal diseases liver diseases

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ventilatory threshold<br>Training at the ventilatory threshold | Other: Training<br>* 20 sessions of training<br>* Other names: Mt;|
| Active Comparator: Metabolic threshold<br>Training at the metabolic threshold | Other: Training<br>* 20 sessions of training<br>* Other names: Mt;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects of training program on mitochondrial function and oxidative stress |  | 6 to 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relationship between mitochondrial function, oxidative stress and exercise tolerance in COPD patients |  | 6 to 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sedentary
Acupuncture for Post Operative Pain Following Total Knee or Hip Arthroplasty

Study Overview
=================
Brief Summary
-----------------
Post operative pain (POP) is a major obstacle on the road to healing, despite the increasing interest in postoperative pain management and development of pain control modalities (1). Postoperative pain is still insufficiently treated with more than 50% of patients suffering from moderate to severe pain early after surgery .Pain after orthopedic surgery is considered especially difficult to manage. Approximately half of total knee or hip arthroplasty patients present with extreme pain immediately after surgery. Total knee and hip arthroplasty often results not only in severe perioperative pain and debilitation, but chronic pain, joint stiffness, and functional disability many months or even years following the procedure. Various modalities of treating orthopedic POP exist, but the optimal management of postoperative pain remains controversial with no clear consensus of the best method.We suggest that acupuncture can be an effective treatment for post operative pain after total knee or hip arthroplasty.

Official Title
-----------------
Acupuncture for Post Operative Pain Following Total Knee or Hip Arthroplasty

Conditions
-----------------
Arthroplasty Complications

Intervention / Treatment
-----------------
* Other: acupuncture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: signed informed consent, above 18 years of age, about to undergo total knee or hip arthroplasty Exclusion Criteria: Known mental disease, active cancer disease, coagulopathy, Hepatitis B,C.

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: acupuncture<br> | Other: acupuncture<br>* acupuncture for post operative pain<br>|
| No Intervention: no acupuncture<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| average post operative pain during time of hospitalization | post operative pain will measured twice daily - morning and afternoon during hospitalization time. patients will be asked to rate thier pain on a visual analog scale ranging from 0- no pain to 10 - severe pain | average pain score during 5 days following operation |
ICG-coated Endoscopic Clip for Tumor Localization

Study Overview
=================
Brief Summary
-----------------
The fluorescent clipping method involves endoscopic clipping a fluorescent clip into the colonic lesion site in advance of surgery, and observing the position of the fluorescence through the colonic wall by a light source of a certain wavelength band during surgery. The purpose of this study is to evaluate the efficacy of the localization of colonic lesions using ICG coated endoscopic clip in laparoscopic colon surgery.

Official Title
-----------------
The Feasibility and Efficacy of ICG-coated Endoscopic Clip for Tumor Localization in Laparoscopic Colorectal Surgery

Conditions
-----------------
Colorectal Neoplasms

Intervention / Treatment
-----------------
* Device: ICG-coated clip


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cases which are deemed necessary to mark the location of the colon lesion before surgery Exclusion Criteria: Preoperative colonoscopy is not possible due to intestinal obstruction If the lesion is located in the rectal area and the lesion can be confirmed by digital rectal exam disagreement with the study

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective single center open label early phase clinical trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ICG clip<br>Three clips are fixed in three directions (120 degrees apart) at the distal of the lesion (just distal) before surgery | Device: ICG-coated clip<br>* Tumor localization using ICG-coated clip prior to surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate of localization | The rate of Identifying ICG-coated clip during surgery | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| loss rate of clips | The rate of detachment of clips before surgery | through study completion, an average of 1 year | 
| Number of Participants with Complication | Procedure-related complication | through study completion, an average of 1 year |
Detection of Clindamycin Resistance Antibiotic Genes Among Staphylococcus Isolates by Using Real Time PCR

Study Overview
=================
Brief Summary
-----------------
Detection of Clindamycin Resistance Antibiotic Genes among Staphylococcus Isolates by Using Real Time PCR

Detailed Description
-----------------
Detection of Clindamycin Resistance Antibiotic Genes among Staphylococcus Isolates by Using Real Time PCR

Official Title
-----------------
Detection of Clindamycin Resistance Antibiotic Genes Among Staphylococcus Isolates by Using Real Time PCR

Conditions
-----------------
Staphylococcus Isolates

Intervention / Treatment
-----------------
* Genetic: Detection of Clinclidamycin Resistance Antibiotic Genes among Staphylococcus Isolates by Using Real Time PCR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all staphylococcus isolates resistant to clindamycin Exclusion Criteria: non
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Clindamycin Resistance Genes among Staphylococcus Isolates by Using Real Time PCR<br> | Genetic: Detection of Clinclidamycin Resistance Antibiotic Genes among Staphylococcus Isolates by Using Real Time PCR<br>* Detection of Clindamycin Resistance Antibiotic Genes among Staphylococcus Isolates by Using Real Time PCR<br>|
| Other: Clindamycin sensetive Antibiotic Genes among Staphylococcus Isolates by Using Real Time PCR<br> | Genetic: Detection of Clinclidamycin Resistance Antibiotic Genes among Staphylococcus Isolates by Using Real Time PCR<br>* Detection of Clindamycin Resistance Antibiotic Genes among Staphylococcus Isolates by Using Real Time PCR<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of Clindamycin Resistance Antibiotic Genes among Staphylococcus Isolates by Using Real Time PCR | Detection of Clindamycin Resistance Antibiotic Genes among Staphylococcus Isolates by Using Real Time PCR | 1 year |
Prospective Multicentre Non-interventional Study of VANTAS® for the Treatment of Patients With Advanced Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
The aim of this non-interventional (observational) study is to document, in collaboration with established urologists in Scandinavia, experience gained from routine use of Vantas® for the treatment of patients with advanced prostate cancer. In this observational study particular attention will be directed to treatment duration, quality of life and patient and physician acceptance of the medicinal product for long-term therapy. Patient-based measurement parameters such as quality of life and degree of satisfaction will allow registration of information that extends beyond the clinical parameters. The knowledge gathered will enable patient acceptance of long-term therapy to be evaluated. Clinical outcome will also be documented by measuring serum testosterone and prostate specific antigen (PSA) levels.

Official Title
-----------------
Prospective, Multicentre, Non-interventional (Observational) Study of VANTAS® for the Treatment of Patients With Advanced Prostate Cancer.

Conditions
-----------------
Prostate Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male patients for whom hormone treatment for advanced prostate cancer is indicated Age > 18 years. Documented elevated PSA levels. Exclusion Criteria: Contraindications for Vantas® (in accordance with Summary of Product Characteristics (SmPC))

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Vantas<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment duration follow-up for each patient. |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood samples | PSA and Testosterone measurement | 1 year | 
| Quality of Life measurements | EORTC documents | 1 year |
A Pilot Study to Explore the Role of Gut Flora in Eczema

Study Overview
=================
Brief Summary
-----------------
This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding eczema.

Detailed Description
-----------------
The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to the information provided in surveys and in medical records regarding eczema.

Official Title
-----------------
A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Eczema

Conditions
-----------------
Eczema

Intervention / Treatment
-----------------
* Other: No Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent by patient Male or female patients age 18 and older. Diagnosis of eczema Exclusion Criteria: Refusal by patient to sign informed consent form Treatment with antibiotics within 2 weeks prior to screening Treatment with probiotics within 6 weeks prior to screening History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy. Postoperative stoma, ostomy, or ileoanal pouch Participation in any experimental drug protocol within the past 12 weeks Treatment with total parenteral nutrition Any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial Inability of patient to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire stud

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Eczema<br>Patients diagnosed with eczema | Other: No Intervention<br>* There is no intervention for this study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of Microbiome to Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) via Relative Abundance Found in Microbiome Sequencing | Relative abundance of bacterial classes within taxonomic phyla and, more broadly, within their domain will be analyzed by sequencing the gut microbiome. These data will then be correlated to Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validation of Sequencing Methods | To validate the methods used to sequence samples | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
microbiome
Non-Invasive Determination of Cardiac Output by Inertgas Rebreathing Method

Study Overview
=================
Brief Summary
-----------------
The cardiac output (CO) is an important parameter in the diagnosis and therapy of cardiac diseases. The current standard methods for the determination of the CO, however, are either invasive (e.g. right heart catheterization) or technically expendable and expensive (magnetic resonance tomography, MRT). The traditional non-invasive methods of determining the CO by rebreathing of carbon dioxide are easily carried out but suffer from methodical inaccuracies. Therefore the aim of the study at hand was to evaluate a new method for determining the CO by means of the inert gas rebreathing method.

Official Title
-----------------
Non-Invasive Determination of Cardiac Output by the Inertgas Rebreathing Method Compared With Magnetic Resonance Tomography

Conditions
-----------------
Cardiac Diseases

Intervention / Treatment
-----------------
* Device: inertgas rebreathing
* Device: spirometry
* Device: cardiac magnetic resonance imaging (CMR)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Indication for CMR Ability of following instructions for rebreathing test

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 90 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: inertgas rebreathing|determination of cardiac output by inertgas rebreathing|
|Device: spirometry|spirometry for testing the ventilatory function|
|Device: cardiac magnetic resonance imaging (CMR)|CMR examination which delivers the hemodynamic reference parameters|

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
-----------------
indication for CMR
Incidence of Large Annular Defects in Primary Lumbar Discectomy Patients

Study Overview
=================
Brief Summary
-----------------
Lumbar discectomy study, collection and evaluation of incidence of large annular defects.

Detailed Description
-----------------
This study is designed as a single-site prospective data collection. Measurements will be collected during 150 consecutive standard of care primary lumbar discectomy procedures.

Official Title
-----------------
Study to Determine Incidence of Large Annular Defects And Measurement of Volume of Nucleus Removed in Primary Discectomy Patients

Conditions
-----------------
Lumbar Disc Herniation, Anular Tear of Lumbar Disc, Nucleus Pulp Hernia;Lumbosac

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be 18-75 years of age, and skeletally mature Must have clinical and radiological evidence of primary lumbar disc herniation at one level of the lumbar spine between L3-S1. Must be psychosocially, mentally and physically able to comply with protocol, post-operative management and follow-up care. Subject must understand and sign the written Informed Consent. Exclusion Criteria: Prior surgery at the index lumbar vertebral level. Subject requires spinal surgery other than a discectomy (with or without laminotomy) to treat leg/back pain Morbid obesity (BMI ≥ 40 kg/m2) Investigational drug or device use within 30 days

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- | --- |
| Incidence of large defects noted on primary lumbar discectomy procedure. | Annular defect size will be measured intra-operatively. | Intra-operatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantify the amount of nuclear disc material removed during primary lumbar discectomy procedure. | Amount of nucleus removed will be measured intra-operatively. | Intra-operatively | 
| Verify access to annular defect with approved manual surgical instruments. | Access to the annular defect will be evaluated intra-operatively. | Intra-operatively |