linjc16/ctgov huggingface dataset:
The Contribution of Heels for Walking Quality Among Children With Muscular Dystrophy

Study Overview
=================
Brief Summary
-----------------
During the stand phase the DMD foot is too plantarflexed in addition patients adopt a higher flexion and abduction of the hip in order to advance the swinging limb. The aim of this work is to assess the immediate contribution of heels for these walking disturbance in children with muscular dystrophy disease.

Conditions
-----------------
Step Time and Length, Symmetry, Step Time and Length Variability, Heart Rate, Gait Velocity

Intervention / Treatment
-----------------
* Device: adding a heel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age >6 yrs walk without heel strike Exclusion Criteria: cannot understand simple instructions

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 15 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 20 children with DMD<br> | Device: adding a heel<br>* walking with and without heels on the gaitrite system<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gait parameters |  | pre and post heels adj. |
Estimate for Dietary Intakes and Hemodialysis Patients

Study Overview
=================
Brief Summary
-----------------
The aim of this clinical research is to evaluate the relevance of using the EPA slide to estimate dietary intakes in dialysis patients. The obtained results will be compared with the reference technique validated by the HAS: food intake over 3 days. The aim is also to improve the global management of dialysis patients and improve their quality of life. The aim is to evaluate a quick and easy-to-use tool whose use has been demonstrated in hospitals but for which no study has been carried out in an ambulatory hospitalization context.

Official Title
-----------------
Evaluation of the Use of an Analog Scale to Estimate Dietary Intakes, EPA, for Hemodialysis Patients

Conditions
-----------------
Nutrition Disorders, Dialysis, Chronic Renal Failure, Dietetician

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient must be able to understand and voluntarily sign an informed consent form Patient with chronic end stage renal failure treated with hemodialysis. Patient with age >= 18 years Exclusion Criteria: Patient treated by peritoneal dialysis Patient with age < 18 years Patient with intellectual limitations that may limit the comprehension of questionnaires Patient with communication disorders or verbal comprehension Patient not French speaking Patient with enteral nutrition Patient having been hospitalized for less than 2 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?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the validity of the EPA to estimate, on an outpatient basis, dietary intakes in dialysis patients | The Gold Standard will calculate the energy intake of the patient from the food intake over 3 days, as a percentage of its energy needs, calculated according to the weight of the patient (actual weight if weight <30kg.m² and weight adjusted if weight ≥ 30kg.m²). | 10 days |
Expanded Access to ABBV-8E12

Study Overview
=================
Brief Summary
-----------------
This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to ABBV-8E12 prior to approval by the local regulatory agency. Availability will depend on territory eligibility. Participating sites will be added as they apply for and are approved for the EAP. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.

Official Title
-----------------
Expanded Access to ABBV-8E12

Conditions
-----------------
Primary Tauopathy Corticobasal Degeneration Syndrome (CBD)

Intervention / Treatment
-----------------
* Drug: ABBV-8E12


Participation Criteria
=================

Ages Eligible for Study
-----------------
Minimum Age: 40 Years


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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ABBV-8E12|Solution for infusion|

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
-----------------
Expanded Access, Pre-approval Access, Compassionate Use, Special Access Program, Named Patient Basis, Special Access Scheme.
Effect of Valdecoxib Pretreatment on Pain and Secondary Hyperalgesia in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
Tis study was designed to test the hypothesis that pretreatment with valdecoxib, prior to injury could reduce or prevent the development of secondary hyperalgesia around the area of primary injury. A heat/capsaicin model of induced hyperalgesia was tested in healthy volunteers in a randomized, double blind, cross-over trial of a single dose of 40 mg vadecoxib versus control. Subjects rated pain intesnsity and unpleasantness following heat stimulation of the forearm, the area of hyperalgesia was also mapped over the course of the experiment.

Official Title
-----------------
Effect of Valdecoxib Pretreatment on Pain and Secondary Hyperalgesia: a Randomized Controlled Trial in Healthy Volunteers

Conditions
-----------------
Pain, Hyperalgesia

Intervention / Treatment
-----------------
* Drug: valdecoxib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy male of non-pregnant female; 18yo or older not currently taking NSAID able and willing to provide informed consent willing to avoid other NSAIDs in 24 hour period following study no known hypersentitivites or contraindications to NSAIDS, sulfonomides or capsaicin Exclusion Criteria: pregnant or breast feeding use of NSAIDS or other analgesic medications in past 7 days unwilling or unable to give informed consent contraindication to any study medication or other NSAID

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in the area of secondary hyperalgesia |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in pain threshold |  |  | 
| Reduction in pain unpleasantness |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pretreatment, healthy volunteers
Role of Microbiome as a Biomarkers in Locoregionally-Advanced Oropharyngeal Squamous Cell Carcinoma

Study Overview
=================
Brief Summary
-----------------
This is a minimal risk feasibility study involving the analysis of patient samples and does not involve any therapeutic intervention. The study will involve a prospective cohort of up to 60 patients diagnosed with Locoregionally-Advanced Oropharyngeal Squamous Cell Carcinoma (LA-OPSCC) treated with chemoradiotherapy (CRT) at Princess Margaret Cancer Centre.

Detailed Description
-----------------
To assess the feasibility of microbiome evaluation in LA-OPSCC patients undergoing CRT using samples collected by four different methods: Saliva, Oropharyngeal swab over the tumor site (OP), Stool, and Rectal swab (optional). This study is investigating the role of oral microbiota as a biomarker in LA-OPSCC. This is a minimal risk study involving the analysis of patient samples and does not involve therapeutic intervention. This protocol does not determine eligibility to receive treatment with concurrent radiotherapy and chemotherapy. It is anticipated that patient accrual will be completed within 12 months. The study will involve a prospective cohort of up to 60 patients diagnosed with LA OPSCC treated with CRT at Princess Margaret Cancer Center.

Official Title
-----------------
Role of Microbiome as a Biomarkers in Locoregionally-Advanced Oropharyngeal Squamous Cell Carcinoma (ROMA LA-OPSCC)

Conditions
-----------------
Locoregionally-advanced Oropharyngeal Squamous Cell Carcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed written and voluntary informed consent. Patient must be willing and able to provide collection for saliva, OP swab and stool specimen analyses at 2 time points. Rectal swab is optional. Age > 18 years, male or female. Patient must be diagnosed with histologically confirmed squamous cell carcinoma of the oropharynx (soft palate, tonsils, base of tongue). Patients must be eligible for curative-intent concurrent treatment with radiotherapy and chemotherapy. Exclusion Criteria: - Any condition that, in the opinion of the Investigator, would interfere with patient safety, or evaluation of the collected specimen and interpretation of study result.

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 |
| --- | --- | --- |
| Feasibility of microbiome evaluation in LA-OPSCC patients undergoing CRT using samples collected by four different methods | To assess the feasibility, the endpoint will be the proportion of analyzable samples. | 1 year | 
| Feasibility of microbiome evaluation in LA-OPSCC patients undergoing CRT using samples collected by four different methods | To assess the feasibility, the endpoint will be the patient compliance rate with sample collection timeline/procedures. | 1 year |
Sleep Quality and Pain Medication Use Following Arthroscopic Rotator Cuff Repair

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate if oral melatonin reduces postoperative sleep 18 disturbances and narcotics use. We will enroll patients undergoing primary arthroscopic rotator 19 cuff repair (ARCR) at the Rothman Institute.

Official Title
-----------------
Sleep Quality and Pain Medication Use Following Arthroscopic Rotator Cuff Repair

Conditions
-----------------
Sleep Disturbance

Intervention / Treatment
-----------------
* Dietary Supplement: melatonin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who undergo primary ARCR Patient willing and able to complete postoperative surveys Exclusion Criteria: Daily melatonin use for > 1 week during the last 3 months Irreparable tears Revision rotator cuff repairs Severe glenohumeral arthritis Concurrent adhesive capsulitis Age less than 18 Pregnancy History of substance abuse (drug or alcohol) Workman's comp patient or patient has current litigation pending Allergy to melatonin History of delirium/psychiatric/depression/ on antidepressants History of insomnia/ on sleep aid medication Use of prescription sedatives use of Zelboraf (vemurafenib) Use of all blood thinning medications besides aspirin (warfarin, plavix, lovenox, etc.) Sleep apnea

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: Crossover Assignment
Interventional Model Description: This is a provider-crossover study design.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Melatonin supplementation<br>5mg melatonin tablets to be taken for 6 weeks | Dietary Supplement: melatonin<br>* Melatonin capsules to be taken for 6 weeks<br>|
| No Intervention: No supplementation<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pittsburg Sleep Quality Index (PSQI) | PSQI is a validated outcome measure for sleep quality | 6 weeks post-surgery |
A Study of Circulating Immune Cell Activity Changes in Blood of Colorectal Cancer Patients

Study Overview
=================
Brief Summary
-----------------
Previous studies have shown that colorectal cancer patients' prognosis and overall survival was related with immune cell expression in patients' tissue. However, the circulating immune cell activity changes in patients' blood has few studies. The purpose of this study is to analyze the variation of circulating immune cell activity in colorectal patients' blood which is classed as clinical staging.

Detailed Description
-----------------
The patients were classed as clinical staging Early (stage1+2) and Late(stage3+4) regional lymph node metastasis Distant metastasis TNM stage

Official Title
-----------------
A Study of Circulating Immune Cell Activity Changes in Blood of Colorectal Cancer Patients

Conditions
-----------------
Colorectal Cancer

Intervention / Treatment
-----------------
* Device: Early stage
* Device: Late stage


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient who was planned to undergo colorectal cancer surgery. Exclusion Criteria: age < 20 years old history of hypersensitivity reaction in propofol or sevoflurane history of previous cancer patient with ongoing inflammation

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Early stage<br>patients who diagnosed as TNM stage 1 and 2 | Device: Early stage<br>* patients who classed as clinical stage 1 and 2<br>* Other names: stage1+2;|
| Late stage<br>patients who diagnosed as TNM stage 3 and 4 | Device: Late stage<br>* patients who classed as clinical stage 3 and 4<br>* Other names: stage3+4;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Circulating helper T cell activity | change of expression level of T cell (0 100 %) | preoperative time | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cytotoxic T cell and natural killer cell activity | change of expression level Cytotoxic T cell and natural killer cell(0 100 %)from 0 to 100) | preoperative time |
Modifying Virtual Reality Analgesia With Low-Dose Pain Medication

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine how pain relief is modified when the investigators combine the Virtual Reality based Snow World game with certain pain medications.

Detailed Description
-----------------
This is a randomized, double-blind, placebo-controlled, within subject 2x2 factorial, repeated measures study. Research participants will play two versions of the Virtual Reality based video game Snow World and be given thermal and electrical stimulus. Each of two study visits will be identical with the exception of whether or not the participant will receive an iv infusion of a low dose pain medication or a saline placebo.

Official Title
-----------------
Modifying Virtual Reality Analgesia With Low-Dose Pain Medication

Conditions
-----------------
Virtual Reality Therapy

Intervention / Treatment
-----------------
* Drug: Low-dose pain medication (Ketalar) and saline placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male and females between the age of 18 and 60 years Ability to communicate orally Ability to read and understand English Body Mass Index between 20-35 Exclusion Criteria: Women who are pregnant, trying to become pregnant, or who are breastfeeding History of alcohol or substance abuse Major medical illness; including history of migraine headaches, seizures, brain injury, or peripheral neuropathy Current use of analgesics including acetaminophen, non-steroidal anti-inflammatories, or opioids Predisposition to severe motion sickness Unusual sensitivity or lack of sensitivity to pain Urine toxicology positive for opioids or benzodiazepines

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Low-dose pain medication<br>80min IV infusion of a low-dose pain medication | Drug: Low-dose pain medication (Ketalar) and saline placebo<br> <br> |
| Placebo Comparator: saline placebo<br>80min IV infusion of a saline placebo | Drug: Low-dose pain medication (Ketalar) and saline placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain responses between placebo and the low-dose pain medication while playing Snow World. We will assess pain responses with subjective questionnaires concerning the participant's experience while playing Snow World. |  | Conclusion of 120 study visits. Each participant will spend a total of 8 hours with us. |
Randomized, Multicenter Trial Comparing TVT With TVT-O for Treatment of Female Urinary Incontinence

Study Overview
=================
Brief Summary
-----------------
The Tensionfree Vaginal Tape (TVT) procedure is a minimally invasive surgical procedure for treatment of female urinary stress incontinence. The TVT procedure has a documented efficacy and safety but is still associated with the risk of intra- and post-operative complications. A modification of the TVT procedure called TVT-O (Tensionfree Vaginal Tape Obturator), which utilises the obturator foramen for passage of the tape, is thought to lower the risk of complications. The trial compares the TVT procedure with the TVT-O procedure in a randomized fashion in order to detect differences in the rate of complications and in cure rate.

Official Title
-----------------
A Randomized, Prospective, Multicenter Trial Comparing TVT With TVT-O Procedures in Treatment of Female Primary Urinary Stress Incontinence

Conditions
-----------------
Urinary Stress Incontinence

Intervention / Treatment
-----------------
* Procedure: TVT and TVT-O minimally invasive surgical procedures
* Procedure: Surgery for female stress urinary incontinence


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: history of stress incontinence indications for surgical treatment positive cough stress test urgency score < 7 Exclusion Criteria: prior incontinence surgery need of concomitant surgery post void residual urine volume < 100 ml urinary tract anomalies urinary tract infection more than 3 urinary tract infection within last year more than grade 2 urogenital prolapse Body mass index > 35 Radiotherapy of the pelvic region active malignancy hemophilia anticoagulant treatment neurological disorder or other disease which affects bladder function anticholinergic treatment use of duloxetine do not understand the purpose of the trial immobility

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: TVT and TVT-O minimally invasive surgical procedures|nan|
|Procedure: Surgery for female stress urinary incontinence|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications |  |  | 
| Objective cure rate by stress test and pad weighing test |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life questionnaires |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Incontinence, Urinary, Female, Surgery, Complications