linjc16/ctgov huggingface dataset:
Using Diffuse Noxious Inhibitory Control (DNIC) to Predict Acupuncture Therapy Outcome: A Pilot Study

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesize that acupuncture modifies the DNIC efficiency and that DNIC can serve as a predictor to identify 'good responders' to acupuncture early in therapy.

Official Title
-----------------
Using DNIC to Predict Acupuncture Therapy Outcome: A Pilot Study

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Other: Acupuncture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy women with a progesterone-coated intrauterine device (Mirena), and Men greater than or equal to 18 years old. Exclusion Criteria: Acupuncture treatment in the previous six weeks, to discount any persisting effect of acupuncture. Treatment of a pain condition with pain medication. Regular use of benzodiazepines. Skin diseases, such as scleroderma, psoriasis or eczema. An adverse event due to acupuncture therapy. Pregnant women. Women without a progesterone-coated intrauterine device (Mirena). Anyone older than 60 years of age, fatigued, with a pacemaker ICD, artificial joint, prolonged bleeding time/hemophilia, open wounds, or a known susceptibility to profound analgesia after acupuncture treatment.

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Acupuncture<br>14 weeks of electroacupuncture therapy. | Other: Acupuncture<br>* Electroacupuncture<br>* Other names: Pantheon Electroacupuncture Device;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diffuse Noxious Inhibitory Control Efficiency | The efficiency of diffuse noxious inhibitory control (DNIC) is a measure of one's ability to inhibit pain perception. DNIC efficiency is assessed by a psychophysical test that involves a heat thermode as the test stimulus and a warm water bath as the conditioning stimulus. The results of this test will be used as the primary outcome measure. | Week 0, 2, 4, 6, and 12 of acupuncture therapy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pain, Acupuncture, DNIC, Electroacupuncture
Gene Therapy for X-linked Chronic Granulomatous Disease (CGD) in Children

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate the side effects and risks after infusion of retroviral gene corrected autologous CD34+ cells of the peripheral blood of chemotherapy conditioned (busulphan) children with chronic granulomatous disease (CGD). Also gene corrected and functional active granulocytes in the peripheral blood and the engraftment in the bone marrow of the patients will be monitored an documented.

Official Title
-----------------
Phase I/II Gene Therapy Study for X-linked Chronic Granulomatous Disease in Children

Conditions
-----------------
Chronic Granulomatous Disease

Intervention / Treatment
-----------------
* Genetic: retroviral SF71-gp91phox transduced CD34+ cells


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: x-linked Chronic Granulomatous Disease history of life-threatening severe infections no HLA-matched related or unrelated donor therapy resistent life threatening infections/organ dysfunction no other treatment options e.g. HSCT Exclusion Criteria: > 18 years of age HIV infection life expectancy > 2 years infections treatable by conventional therapy (antibiotics, antimycotics, allogeneic granulocytes)

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 18 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: retroviral SF71-gp91phox transduced CD34+ cells|autologous ex-vivo transduced (SF71-gp91phox)CD34+ cells|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| eradication of pre-existing therapy refractory bacterial and/or fungal infections |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reconstitution of ROS production by peripheral blood cells |  | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Granulomatous Disease in children (=or< 18 years)
Screen to Save: A Colorectal Cancer Educational Intervention

Study Overview
=================
Brief Summary
-----------------
The purpose of this research is to understand if an educational program about colorectal cancer helps improve people's knowledge of colorectal cancer prevention and screening and their intention to get screened for colorectal cancer.

Official Title
-----------------
Screen to Save: A Colorectal Cancer Educational Intervention

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

Intervention / Treatment
-----------------
* Behavioral: Inflatable colon educational module


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: 50-74 years old Attendee at event where educational module is offered

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 74 Years

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

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

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

Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Inflatable colon educational module<br>Participants attend a brief educational presentation in an inflatable colon, focused on colorectal cancer prevention and screening. Participants also receive a copy of the study information sheet and may receive written educational materials to take home. Participants complete a pre-test and a post-test to assess changes in knowledge and intention to get screened for colorectal cancer. | Behavioral: Inflatable colon educational module<br>* Participants attend a brief educational presentation in an inflatable colon, learning about colorectal cancer prevention and screening.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Knowledge Related to Colorectal Cancer Risk, Prevention, and Screening | A pre-test and post-test is conducted with participants to assess any changes in knowledge related to key learning outcomes expected from the educational intervention (assessed via 14 questions before and after learning). | Baseline and immediately following intervention | 
| Number of Participants With Varying Levels of Behavioral Intentions Related to Colorectal Cancer Screening and Prevention | Post-test conducted to assess behavioral intention related to five prevention and screening behaviors (assessed via 5 questions on a 4-point Likert scale, where a higher score indicates stronger behavioral intention). The scale for all behavioral intention measures started with, As a result of the colorectal cancer screening information I received during the Screen to Save educational session, I am more likely to… | Immediately following intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Knowledge
Blood Biomarkers in Pediatric Kidney Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
The objective of the proposed study is to assess whether a blood biomarker can be used to monitor the response to rejection treatment in pediatric kidney transplant recipients with biopsy-proven acute cellular or antibody mediated rejection. The study hypothesizes that blood gene expression profile and donor-derived cell-free DNA biomarkers (omnigraf) can be used to predict acute rejection and monitor its response to treatment.

Official Title
-----------------
Use of Blood Gene Expression Profile and Donor-derived Cell-free DNA to Monitor Response to Treatment After Biopsy-proven Acute Rejection in Pediatric Kidney Transplant Recipients

Conditions
-----------------
Rejection of Kidney Allograft

Intervention / Treatment
-----------------
* Other: Observational group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Kidney transplant recipients Participants undergoing a for-cause kidney biopsy to rule out graft rejection Ages 21 years and less Exclusion Criteria: Participants who have opted out of research Patients, less than 18 years of age, whose parents or legal guardians are illiterate and cannot read. Participants, 18 years and older, who are illiterate and cannot read. Participants, less than 18 years of age, whose parents or legal guardians do not speak English. Participants, 18 years and older, who do not speak English Participants who are pregnant as confirmed by medical records

Ages Eligible for Study
-----------------
Maximum Age: 21 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Observational group|Includes blood draws and data collection only|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biopsy-proven acute rejection | Yes or No assessment | 7 days from baseline | 
| Clinical resolution of rejection | Yes or No assessment; defined as improvement in serum creatinine to a value that is within 25% of baseline serum creatinine | 8 weeks from baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acute rejection, kidney transplant, pediatric, biomarker, cell free DNA
Collecting Stem Cells in Patients With Waldenstrom's Macroglobulinemia

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Collecting and storing stem cells to study in the laboratory may help doctors learn more about collecting stem cells from patients who have undergone treatment for Waldenstrom's macroglobulinemia. PURPOSE: This laboratory study is collecting stem cells from patients with Waldenstrom's macroglobulinemia.

Detailed Description
-----------------
OBJECTIVES: Harvest and store adequate CD34+ stem cells from patients with Waldenstrom's macroglobulinemia (WM) for potential future use in transplantation strategies. Evaluate the ability to harvest stem cells after therapy for WM (e.g., fludarabine-based chemotherapy) by evaluating the number of days to adequate harvest. Collect aliquots of stem cells for future research analysis as part of a WM database project. OUTLINE: Patients undergo collection of autologous stem cells beginning on day 4 or 5 and continuing until an adequate number of stem cells are collected. Cells are then cryopreserved. PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Official Title
-----------------
Autologous Stem Cell Harvesting for Waldenstrom's Macroglobulinemia

Conditions
-----------------
Lymphoma

Intervention / Treatment
-----------------
* Procedure: leukapheresis


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Diagnosis of Waldenstrom's macroglobulinemia (WM) Less than 30% lymphoplasmacytoid cells in bone marrow by histopathology Received prior chemotherapy for WM PATIENT CHARACTERISTICS: ECOG performance status 0-1 WBC > 2,000/mm³ Platelet count > 50,000/mm³ LVEF ≥ 50% No organ dysfunction that would preclude future transplantation PRIOR CONCURRENT THERAPY: See Disease Characteristics

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 |
| --- |
|Procedure: leukapheresis|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of days to adequate stem cell harvest |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Waldenström macroglobulinemia
Do Xanthine Oxidase Inhibitors Reduce Both Left Ventricular Hypertrophy and Endothelial Dysfunction in Cardiovascular Patients With Renal Dysfunction?

Study Overview
=================
Brief Summary
-----------------
Cardiovascular related disease is the main cause of death in patients with kidney disease, and oxidative stress is thought to be a major contributor by promoting thickening of the heart muscle and stiffening of the arteries. Allopurinol, a drug used safely in the treatment of gout for many years, has been found to dramatically reduce oxidative stress. It is therefore hoped that it also reduce the thickened heart muscle and stiffened arteries. If it did, it is likely to reduce the appallingly high cardiac death rate in this group of kidney disease patients.

Official Title
-----------------
Do Xanthine Oxidase Inhibitors Reduce Both Left Ventricular Hypertrophy and Endothelial Dysfunction in Cardiovascular Patients With Renal Dysfunction?

Conditions
-----------------
Kidney Disease, Left Ventricular Hypertrophy

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: CKD stage 3 Echo LVH Exclusion Criteria: Known heart failure Patients already on Allopurinol Patients with gout Patients with hepatic disease Contraindications to MRI, including severe claustrophobia Current immunosuppressive therapy, chlorpropamide, theophylline, 6- mercaptopurine Malignancy or other life threatening disease Pregnancy or lactating women Patients unable to provide written consent

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: I<br>CKD Stage 3 (estimated GFR 30 - 60 ml/min/1.73m2), Echo LVH | Drug: Placebo<br>* 1 capsule, orally for 9 months<br>|
| Active Comparator: 2<br> | Drug: Allopurinol<br>* Allopurinol 300 mg once/day orally, 9 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary objective is to see if Allopurinol reduces left ventricular hypertrophy (LVH) in this group of CKD patients |  | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary objective is to see if Allopurinol reduces endothelial dysfunction in this group of CKD patients |  | 9 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CKD, LVH, Echo LVH, Chronic Stage 3
The Management of Pilonidal Wounds With ACell MicroMatrix® and Cytal® Wound Matrix: A Case Series

Study Overview
=================
Brief Summary
-----------------
A case series involving the concomitant use of MicroMatrix® and Cytal® Wound Matrix 2-Layer with standard of care negative pressure wound therapy (NPWT) during the management of pilonidal wound healing.

Detailed Description
-----------------
This is a prospective case series examining the concomitant use of MicroMatrix® and Cytal® Wound Matrix 2-Layer with standard of care negative pressure wound therapy (NPWT) during the management of pilonidal wound healing. Wound healing will be evaluated at 2 weeks, 6 weeks, and 3 months. If subjects heal prior to the 3 month visit, wound healing will be documented at that visit. A maximum of ten subjects will be included in this series.

Official Title
-----------------
The Management of Pilonidal Wounds With ACell MicroMatrix® and Cytal® Wound Matrix: A Case Series

Conditions
-----------------
Pilonidal Disease

Intervention / Treatment
-----------------
* Device: Wound Sheet Matrix 2-Layer and Powder Urinary Bladder Matrix


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject has a clinical diagnosis of pilonidal disease. Subject is being scheduled for surgical excision of pilonidal disease. Subject is at least 18 years of age. Subject is willing and able to adhere to protocol requirements and agrees to participate in the study program and comply with the study follow-up regimen. Subject is willing to provide written informed consent. Exclusion Criteria: Subject has a known allergy to porcine-based materials. Subject is pregnant

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 |
| --- |
|Device: Wound Sheet Matrix 2-Layer and Powder Urinary Bladder Matrix|Porcine-derived extracellular matrix will be used in powder and 2-Layer wound sheet form in masses up to 1000 mg. Each product is intended for a one-time use only.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Wound Closure | The study was terminated by Sponsor; no outcome measure data analyses were conducted. | Up to 3 month visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ACell, ACell MicroMatrix®, ACell Cytal® Wound Matrix, Urinary Bladder Matrix
Seizure Prophylaxis in Aneurysm Repair

Study Overview
=================
Brief Summary
-----------------
After a thorough review of the existing literature as well as a review of our own practice, the investigators have concluded that the decision to treat patients undergoing aneurysm repair with levetiracetam has reached true clinical equipoise. In other words, the investigators cannot favor a decision to either administer or not administer this drug in these patients based on the existing information. The utility of anti-epileptic prophlaxis in the perioperative period for patients undergoing intracranial aneurysm repair remains a common practice that is not supported by the current literature that includes retrospective analyses as well as prospective trials for similar but not identical types of patients. The investigators propose to settle this dilemma by performing a prospective randomized trial in patients undergoing aneurysm repair in order to definitively determine if the common practice of perioperative antiepileptic drug administration has any utility. The study will be extended to June 2024 to allow for a 5 year follow up of the last enrolled patient in June, 2019.

Official Title
-----------------
Seizure Prophylaxis in Aneurysm Repair

Conditions
-----------------
Intracranial Aneurysms, Seizure

Intervention / Treatment
-----------------
* Drug: Levetiracetam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult (≥18 years) Presence of intracranial aneurysm (with or without rupture) Treating surgeon has recommended surgical repair of the aneurysm Exclusion Criteria: History of seizures within last 10 years History of epilepsy History of prior stroke Currently prescribed medication with anti-epileptic activity (keppra, dilantin, tegretol, lamictal, topamax, etc.) Brain tumor Pregnant or nursing woman Known levetiracetam allergy

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Levetiracetam<br>500 mg intravenous dose during the operative case then 500 mg orally twice a day for a total of seven days. | Drug: Levetiracetam<br>* Details covered in Arm Descriptions.<br>* Other names: Keppra;|
| No Intervention: No levetiracetam<br>No levetiracetam | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of seizure | Incidence of seizure - data collected at 2 months, 6 months, 12 months, and 5 years. | 5 years from procedure |