linjc16/ctgov huggingface dataset:
SCS Research Study

Study Overview
=================
Brief Summary
-----------------
To characterize the effects of stimulation parameters on pain relief and other cohort specific outcomes.

Detailed Description
-----------------
This post market study will measure the following: Numeric Pain Rating Scale Satisfaction and Stimulation Assessment Stimulation feedback Stimulation parameters Anatomical locations of active contacts Stimulation thresholds Location of paresthesia Oswestry Disability Index European Quality of Life 5-Dimensions To characterize non-invasive health monitoring data

Official Title
-----------------
Spinal Cord Stimulation Research Study

Conditions
-----------------
Trunk Pain, Limb Pain

Intervention / Treatment
-----------------
* Device: Spinal Cord Stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 22 years of age or older Implanted with a Medtronic rechargeable neurostimulation system, for a labeled indication, for at least 1 month and expected longevity of neurostimulator is at least 5 months Willing and able to provide signed and dated informed consent Capable of comprehending and consenting in English Willing and able to comply with all study procedures, including diary completion, and visits Able to differentiate between pain associated with the indication for SCS implant and other types of pain Exclusion Criteria: Implanted with neurostimulation system for an off-label indication Currently enrolled or planning to enroll in an interventional clinical study that could potentially confound the study results If female, pregnant or is of child-bearing potential and unwilling to use a medically acceptable form of birth control during the study Has untreated major psychiatric comorbidity Has a non-rechargeable neurostimulator where the battery longevity is not able to be estimated with the battery longevity calculator

Ages Eligible for Study
-----------------
Minimum Age: 22 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 |
| --- | --- |
| Experimental: Spinal Cord Stimulation<br>Each subject will be programmed to different settings. | Device: Spinal Cord Stimulation<br>* Programming<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numeric pain rating scale | To characterize the effect of different programmed settings on pain relief. The NPRS will be recorded in clinic or once a day on a multi-day diary, where the subjects will rate their pain on a 11-point numeric rating scale of 0 to 10, with 0 representing 'No Pain' and 10 representing 'Worst pain imaginable'. The average overall NPRS pain score from the diary prior to the scheduled visit will be used for analysis. | Up to 16 months |
Endoscopic Pilonidal Sinus Treatment (EPSIT) Versus Sinus Laser Closure (SiLaC) Versus Lay Open Technique

Study Overview
=================
Brief Summary
-----------------
Aim of the work To compare Sinus Laser closure versus lay open technique versus Endoscopic pilonidal sinus treatment as regards recurrence rate, operative data, postoperative pain, intra and postoperative complications, healing time and return to daily activity.

Official Title
-----------------
Endoscopic Pilonidal Sinus Treatment (EPSIT) Versus Sinus Laser Closure (SiLaC) Versus Lay Open Technique

Conditions
-----------------
Pilonidal Sinus

Intervention / Treatment
-----------------
* Procedure: Endoscopic Pilonidal sinus treatment (EPSIT) versus Sinus Laser Closure (SiLaC) versus lay open technique


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with symptoms from sacrococcygeal pilonidal sinus . Exclusion Criteria: Abscess formation Immunodeficiency. Patients with congenital asymptomatic pits. Patient with psychiatric disease disabling surgical intervention. . Pregnant females.
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 |
| --- | --- |
| Active Comparator: Endoscopic Pilonidal sinus treatment (EPSIT)<br>Endoscopic Pilonidal sinus treatment (EPSIT) | Procedure: Endoscopic Pilonidal sinus treatment (EPSIT) versus Sinus Laser Closure (SiLaC) versus lay open technique<br>* Endoscopic Pilonidal sinus treatment (EPSIT) versus Sinus Laser Closure (SiLaC) versus lay open technique in sacrococcygeal Pilonidal sinus treatment<br>|
| Active Comparator: Sinus Laser Closure (SiLaC)<br>Sinus Laser Closure (SiLaC) | Procedure: Endoscopic Pilonidal sinus treatment (EPSIT) versus Sinus Laser Closure (SiLaC) versus lay open technique<br>* Endoscopic Pilonidal sinus treatment (EPSIT) versus Sinus Laser Closure (SiLaC) versus lay open technique in sacrococcygeal Pilonidal sinus treatment<br>|
| Active Comparator: lay open technique<br>lay open technique | Procedure: Endoscopic Pilonidal sinus treatment (EPSIT) versus Sinus Laser Closure (SiLaC) versus lay open technique<br>* Endoscopic Pilonidal sinus treatment (EPSIT) versus Sinus Laser Closure (SiLaC) versus lay open technique in sacrococcygeal Pilonidal sinus treatment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence | Recurrence of pilonidal sinus after treatment | one year |
Evaluation of Patient Satisfaction and Therapeutic Impact Regarding Joint Consultation Rheumatologist/Dermatologist

Study Overview
=================
Brief Summary
-----------------
Current increase in the number of multidisciplinary consultations, but little documentation on their impact on patient management. More specifically, in the context of psoriatic arthritis, we are seeking to investigate the interest for the patient, through his or her satisfaction and the evolution of the activity of his or her pathology, of a global, joint management in Rheumatology and Dermatology.

Official Title
-----------------
Evaluation of Patient Satisfaction and Therapeutic Impact Regarding Joint Consultation Rheumatologist/Dermatologist

Conditions
-----------------
Psoriatic Arthritis

Intervention / Treatment
-----------------
* Other: questionnaires


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients received in a joint rheumatologist/dermatologist consultation at the Le Mans Hospital Exclusion Criteria: Diagnosis of psoriatic arthritis not retained

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: questionnaires|questionnaires about disease and satisfaction of patient|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| impact on patient satisfaction and the evolution of their pathology of these mixed consultations, Dermatologist and Rheumatologist, in the context of psoriatic arthritis. | evaluate the impact on patient satisfaction and the evolution of their pathology of these mixed consultations, Dermatologist and Rheumatologist, in the context of psoriatic arthritis. | 5 years after inclusion |
Interplay of Self-Criticism and Symptom Severity Over the Course of In-patient Psychotherapeutic Treatment

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the interplay between self-criticism and symptom severity in patients undergoing psychotherapeutic treatment.

Detailed Description
-----------------
Participants are recruited at the University Clinic Heidelberg at the beginning of their (usually) 8-week in-patient treatment, consisting of somatic and psychotherapeutic aspects. After informed consent, patients routinely fill out weekly questionnaires about their self-criticism and their symptom severity. The overall aim of this study is to disentangle stable (between-person) effects of both self-criticism and symptom severity from within-person effects happening over time in order to better understand what drives what, or in other words, their dynamic interplay. The analysis is based on the weekly assessment of the patients. All patients receive the standard care of the in-patient treatment.

Official Title
-----------------
Assessment of the Interplay Between Self-critisim and Symptom Severity Over the Course of In-patient Psychotherapeutic Treatment

Conditions
-----------------
Self-Criticism, Psychological Distress, In-Patient Treatment

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Undergoing in-patient treatment at the University Clinic Heidelberg (Klinik für Allgemeine Innere Medizin und Psychosomatik) Exclusion Criteria: none

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SCL-K11 | Symptom Check-List German Short Version with 11 Items | Weekly Assessments over the course of the in-patient treatment (usually about 8 weeks) | 
| TDEQ-12 (Subscale Self-Criticism | Theoretical Depressive Experiences Questionnaire German Short Version with 12 Items: Subscale Self-Criticism | Weekly Assessments over the course of the in-patient treatment (usually about 8 weeks) |
Health-related Quality of Life of Patients With Neurogenic Bladder

Study Overview
=================
Brief Summary
-----------------
Bladder management has a major impact on the quality of life in patients with neurogenic bladder dysfunction. This a prospective investigation of the effects of the method for bladder evacuation on the health-related quality of life in patients with neurogenic bladder dysfunction. The changes in health-related quality of life over time (longitudinal investigation) and the differences between the different methods for bladder evacuation will be investigated. Patients will be given a standardized and validated questionnaire annually for 10 years.

Official Title
-----------------
Effects of Bladder Management on Health-related Quality of Life in Patients With Neurogenic Bladder

Conditions
-----------------
Neurogenic Bladder Dysfunction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Individuals with neurogenic bladder dysfunction Exclusion Criteria: Insufficient dexterity to fill in the questionnaire Insufficient proficiency in the German or French language

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| neurogenic bladder dysfunction<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life | Qualiveen questionnaire | up to year 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bladder evacuation method | method for bladder evacuation (i.e. intermittent catheterization, condom urinal, reflex micturition, transurethral catheter, suprapubic catheter, sacral bladder stimulator, neuromodulation) | year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 | 
| urinary tract infections | number of annual symptomatic urinary tract infections | year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 | 
| patient characteristics | gender, age, type of neurogenic bladder dysfunction, duration of neurogenic bladder dysfunction | time 0 |
Breakfast Knowledge, Beliefs, and Habits of Exercising Adults

Study Overview
=================
Brief Summary
-----------------
This study is being done to determine typical breakfast consumption habits in various populations of exercisers. Participants will be asked a series of questions pertaining to their participation in regular exercise, their current breakfast consumption, food preferences, meal timing, and general knowledge of sports nutrition and pre-exercise breakfast consumption.

Detailed Description
-----------------
Participants will complete a one-time survey regarding breakfast habits and beliefs and sports nutrition knowledge, as well as the type, frequency, and intensity of exercise engaged in on a weekly basis.

Official Title
-----------------
Breakfast Knowledge, Beliefs, and Habits of Exercising Adults

Conditions
-----------------
Nutrition

Intervention / Treatment
-----------------
* Other: survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18+ years old regular exerciser Exclusion Criteria: younger than 18 years old do not regularly exercise

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 |
| --- | --- |
| Athlete<br>those who identified as participating in athletic competitions at DI, intramural, club or competitive levels | Other: survey<br>* survey asking questions regarding breakfast habits and composition, sports nutrition knowledge and exercise habits<br>|
| non-athletes<br>those who did not identify as participating in athletic competitions at DI, intramural, club or competitive levels | Other: survey<br>* survey asking questions regarding breakfast habits and composition, sports nutrition knowledge and exercise habits<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| breakfast composition | Questions asked include typical composition of breakfast, such as Meat, Plant-based protein (beans, lentils, peas), Nuts or seeds, Cheese, Eggs, Yogurt or dairy, Bread, Starchy vegetables, Non-starchy vegetables, Grains, Fruit/fruit juice, or Protein/meal replacement bars | Day 1 | 
| breakfast habits | questions regarding typical breakfast consumption habits | Day 1 | 
| breakfast beliefs | questions regarding how individuals felt about eating breakfast | Day 1 | 
| sports nutrition knowledge | questions from the 49-SNKI to assess sports nutrition knowledge | Day 1 | 
| exercise habits | questions on frequency, duration and intensity of typical exercise sessions | Day 1 |
TTE and Dysphagia in Anterior Cervical Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate if Tracheal Traction Exercises (TTE) performed prior to anterior cervical spine surgery can result in a decreased rate of dysphagia.

Official Title
-----------------
Investigating the Role of Tracheal Traction Exercises (TTE) in Reducing Dysphagia Following Anterior Cervical Surgery

Conditions
-----------------
Dysphagia

Intervention / Treatment
-----------------
* Other: Trachael Preparation Education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elective Anterior cervical spine surgery (C2-C7) for degenerative disc disease or myelopathy Exclusion Criteria: More than four levels of fusion Trauma or urgent cases of anterior cervical spine surgery Prior anterior cervical spine surgery (a known risk factor for dysphagia), Prior neck surgery (eg. Thyroidectomy) Tumors Infections Neurological disorders that can predispose to dysphagia such as Parkinson's, Cerebrovascular Accidents (CVA), Alzheimer's and Amyotrophic Lateral Sclerosis.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Trachael Traction Exercises | Other: Trachael Preparation Education<br> <br> |
| Placebo Comparator: Group 2<br>Trachael Massage | Other: Trachael Preparation Education<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SWAL-QOL | 30% difference in dysphagia as quantified by the SWAL-QOL (validated measure of dysphagia) | 12 months |
Cognitive Impairment in Colorectal Cancer Patients Receiving Cytotoxic Chemotherapy

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to see how the brain changes in patients receiving chemotherapy (cytotoxic drug) treatment for colon or rectal cancer at Parkview Cancer Institute. This information will be used to identify helpful tests to diagnose individuals at risk for developing difficulties with thinking and memory due to their cancer treatments.

Official Title
-----------------
Cognitive Impairment in Colorectal Cancer Patients Receiving Cytotoxic Chemotherapy

Conditions
-----------------
Chemotherapy Effect, Neoplasm, Colorectal, Cognitive Impairment, Cognitive Dysfunction, Cognitive Change, Chemo-brain, Chemo Fog, Cognitive Decline

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed written informed consent must be obtained and documented according to International Conference on Harmonisation (ICH)- Good Clinical Practice (GCP), the local regulatory requirements, and permission to use private health information in accordance with the Health Insurance Portability and Accountability Act (HIPAA) prior to study-specific screening procedures. Must be able to provide study-specific informed consent prior to study entry. A histologically-confirmed colorectal tumor Patients who will be treated with cytotoxic chemotherapies including Capecitabine, Oxaliplatin, 5 fluorouracil, and Irinotecan are eligible. Patients must not have received cytotoxic chemotherapy previous to enrollment. Exclusion Criteria: Prior administration of anti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents Patients having mental incompetence as assessed by study PI, which would hinder completion of the surveys Pregnant or breastfeeding Any known brain metastases Non-English speaking patients Patients who have been diagnosed with any neuro-cognitive disorder including traumatic brain injuries, Alzheimer's disease, Parkinson's disease, Huntington's disease, and Creutzfeldt-Jakob disease. Patients deemed inappropriate to participate in this study by the study PI or coordinator will be excluded.

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 |
| --- | --- | --- |
| Survey | FACT-Cog V3 | 7 Years | 
| The Proteome Profiler Human XL Cytokine Array Kit (https://www.rndsystems.com/products/proteome-profiler-human-xl-cytokine-array-kit_ary022b) | This panel of plasma factors will be will be used to detect protein from the blood of patients throughout and after chemotherapy treatment. | 7 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Palliative Care, Palliative Oncology, Supportive Care, Supportive Oncology, Cognitive Impairment, Chemo Brain
Supported Treadmill Ambulation Training After Spinal Cord Injury

Study Overview
=================
Brief Summary
-----------------
This is a randomized, controlled trial to compare supported treadmill ambulation training (STAT) to conventional gait training for improving gait speed, gait endurance, gait efficiency and muscle function in SCI subjects injured more than six months prior to start of training. Each subject will receive twelve weeks of either CGT or STAT, given as 20 minutes of training within a one-hour period per day, five days per week. These subjects will be studied baseline, 4,8 and 12 weeks of training, and three months after the end of training with a battery of tests designed to evaluate the subjects' gait and muscle function.

Official Title
-----------------
Supported Treadmill Ambulation Training After Spinal Cord Injury

Conditions
-----------------
Spinal Cord Injury

Intervention / Treatment
-----------------
* Procedure: Ambulation Training


Participation Criteria
=================
Eligibility Criteria
-----------------
Spinal cord injury

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

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Ambulation Training|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
-----------------
Spinal cord injury, ambulation, treadmill