linjc16/ctgov huggingface dataset:
Co-transplantation of MSC in the Setting of Allo-HSCT

Study Overview
=================
Brief Summary
-----------------
Mesenchymal stem cells (MSCs) are known to exhibit immunomodulatory, anti-inflammatory, and pro-angiogenic properties, and therefore have the potential to improve the outcome of allogeneic hematopoietic stem cell transplantation (allo-HSCT) .The study is aimed to identify and evaluate the potential benefits of MSCs infusion during allogeneic HSCT, with regard to the engraftment, graft versus host disease (GVHD), post-transplant relapse and survival.

Official Title
-----------------
Co-transplantation of Mesenchymal Stromal Cells in Allogeneic Hematopoietic Stem Cell Transplantation

Conditions
-----------------
Allogeneic Hematopoietic Stem Cell Transplantation

Intervention / Treatment
-----------------
* Biological: Cotransplant with MSCs


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed written informed consent Aged <65 years Willing to transplant Cardiac: Left ventricular ejection fraction ≥ 50% Adequate renal and hepatic function Performance status: Karnofsky ≥ 70% Exclusion Criteria: Pregnant or lactating females. Any co-morbidity precluding the administration of MSCs.

Ages Eligible for Study
-----------------
Maximum Age: 65 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: HSC<br> | |
| Experimental: MSC+HSC<br> | Biological: Cotransplant with MSCs<br>* Co-transplantation of MSCs during allogeneic HSCT<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival Rate |  | up to 2 years after HSCT | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative Incidence of Graft-versus Host Disease |  | up to 2 years after HSCT | 
| Incidence of Systemic Infections |  | up to 2 years after HSCT | 
| Mean Time to Engraftment |  | Baseline to engraftment, assessed minimally 28 days post transplant | 
| Transplant-Related Mortality |  | up to 1 months after HSCT | 
| Rates of Relapse |  | up to 2 years after HSCT |
Diagnosis/Pathophysiology of Glucocorticoid Remediable Aldosteronism Hypertension

Study Overview
=================
Brief Summary
-----------------
To identify and study a large cohort of glucocorticoid remediable aldosteronism (GRA) patients.

Detailed Description
-----------------
DESIGN NARRATIVE: The spectrum of the severity and the natural history of the disorder was characterized. Modifying environmental and genetic factors important in regulation of blood pressure were determined. Also, renal physiology was studied in GRA patients to determine how these patients escaped hypokalemia in spite of mineralocorticoid excess. There were four specific aims including: 1) to determine the natural history and prevalence of GRA in various hypertensive populations, 2) to characterize the magnitude of effect imparted on blood pressure by inheritance of GRA and the sources of variation in phenotype expression of the hypertension, 3) to investigate the renal and hormonal mechanisms regulating potassium conservation and loss in GRA, and 4) to characterize the disequilibrium of GRA with Irish and Scottish descent and specific alleles of the aldosterone synthase gene. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Cardiovascular Diseases, Hypertension, Heart Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 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 |
| --- | --- | --- |
Wind Instruments' Fungal Contamination

Study Overview
=================
Brief Summary
-----------------
On the basis of 2 cases of immunologically-induced lung disease in 2 saxophonists, the investigators supposed that wind reed instruments could be contaminated with molds. The investigators led a study on 40 musicians playing a wind reed instrument to analyze instruments' fungal contamination and its immunological and clinical consequences for musicians.

Official Title
-----------------
Study of Wind Reed Instruments' Fungal Contamination and Its Immunological and Clinical Consequences for Musicians.

Conditions
-----------------
Immunologically-induced Lung Disease, Hypersensitivity Pneumonitis

Intervention / Treatment
-----------------
* Biological: blood sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: must be 18 year old or more must play a wind reed instrument (saxophone, clarinet, bassoon or oboe) one hour per week or more Exclusion Criteria: refuse to sign 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: Diagnostic


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: blood sample|blood sample in each musician to search for specific antibodies against molds isolated from instruments|

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
-----------------
wind instruments, molds, hypersensitivity pneumonitis, fungal contamination of wind instruments, specific antibodies against molds in musicians' sera, musicians
Sunitinib and Atrial Trabeculae Contractility

Study Overview
=================
Brief Summary
-----------------
Rationale: Recently, sunitinib (a tyrosine kinase inhibitor that is used for treatment of metastatic renal carcinoma and gastrointestinal stroma tumors) has been associated with development of heart failure, possibly by off-target inhibition of AMP-protein kinase. The investigators hypothesize that sunitinib reduces the contractile ability of myocardium and the tolerance against ischemia-reperfusion and that activators of AMP-protein kinase such as atorvastatin and AICAR reverse this unwanted effect of sunitinib. Objectives: The primary objective of the study is to investigate the effect of sunitinib on ex-vivo atrial contractile force in absence and presence of ischemia-reperfusion. A secondary objective is to explore if atorvastatin or AICAR prevent sunitinib-induced deterioration of contractile function of human atrial trabeculas. Study design: Lab

Detailed Description
-----------------
Study population: 44 (+22) patients undergoing CABG cardiac surgery with extracorporal circulation Intervention (if applicable): none (pharmacological interventions will only be performed ex-vivo in isolated atrial tissue) Main study parameters/endpoints The developed force in ex vivo atrial trabeculas during standardized stimulation.

Official Title
-----------------
The Influence of Sunitinib on Contractility of Human Atrial Trabeculae

Conditions
-----------------
Cardiotoxicity, Ischemia, Heart Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cardiac surgery with extracorporal circulation Exclusion Criteria: Use of oral antiarrhythmics theophylline use Use of sulfonylureas Atrial arrythmias Right ventricular failure

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 |
| --- | --- |
| With/without sunitinib<br>Two trabeculas will be isolated and one will be exposed to sunitinib and the other to normal buffer solution. Both will be stimulated to contraction during 200 minutes. | |
| With/without sunitinib IP<br>Two trabeculas will be isolated and one will be exposed to sunitinib and the other to normal buffer solution. Both will be stimulated to contraction and ischemia/reperfusion | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Force | The developed force in ex vivo atrial trabeculae during standardized stimulation. | 200 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Speed | The difference in averaged maximal speed of tension reduction during relaxation between two trabeculae | 200 minutes | 
| Maximal Speed | The difference in averaged maximal speed of tension development during contraction between two trabeculae. | 210 minutes |
VX-445/TEZ/IVA Expanded Access Program for Cystic Fibrosis (CF) Patients Heterozygous for F508del Mutation and a Minimal Function Mutation (F/MF Genotypes)

Study Overview
=================
Brief Summary
-----------------
The purpose of this program is to provide elexacaftor(ELX, VX-445)/tezacaftor(TEZ)/ivacaftor(IVA) combination therapy to CF patients in critical need who are 12 years of age and older, heterozygous for F508del and a minimal function (MF) mutation in response to unsolicited physician requests.

Official Title
-----------------
VX-445/TEZ/IVA Triple Combination Expanded Access Program for Patients 12 Years of Age and Older With Cystic Fibrosis Who Are Heterozygous for F508del and a Minimal Function CFTR Mutation

Conditions
-----------------
Cystic Fibrosis

Intervention / Treatment
-----------------
* Drug: ELX/TEZ/IVA
* Drug: IVA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Patients who have F/MF genotypes AND who meet at least 1 of the following criteria: The percent predicted forced expiratory volume in 1 second (ppFEV1) is <40 for a minimum of 2 months before the date of the request, OR Documentation of being active on a lung transplant waiting list or documentation of being evaluated for lung transplantation, but deemed unsuitable because of contraindications Exclusion Criteria: Patients with severe hepatic impairment (Child-Pugh Class C) History of any other comorbidity that, in the opinion of the treating physician, might pose undue risk in administering ELX/TEZ/IVA to the patient Pregnancy Other protocol defined Inclusion/Exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 12 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ELX/TEZ/IVA|Fixed-dose combination tablet for oral administration.|
|Drug: IVA|150-mg tablet for oral administration.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Long-term Safety and Tolerability of AFFITOPE AD01

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the long-term tolerability and -safety of AFFITOPE AD01 applied during AFFiRiS 001

Official Title
-----------------
Phase Ib Follow-up Study to Evaluate Long-term Safety and Tolerability of Immunization With AFFITOPE AD01 Applied During AFFiRiS 001

Conditions
-----------------
Alzheimer's Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent signed and dated by the patient or the patient's legal representative and the caregiver Patients having participated in AFFiRiS 001 and received at least 1 vaccination with AFFITOPE AD01 Availability of a partner/caregiver knowing the patient and being able to accompany the patient to the visits. Exclusion Criteria: Patients having received no vaccination with AFFITOPE AD01 Contraindication for MRI imaging History of questionable compliance to visit schedule, patients not expected to complete the clinical trial

Ages Eligible for Study
-----------------
Minimum Age: 50 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 |
| --- | --- |
| 1<br>AFFITOPE AD01 | |
| 2<br>AFFITOPE AD01 + Adjuvant | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunological and clinical efficacy (evaluated in an explorative manner only) |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alzheimer, Morbus Alzheimer, Alzheimer Vaccine, Vaccine, AD, A-beta immunotherapy
Long Term Outcome After Ahmed Glaucoma Valve

Study Overview
=================
Brief Summary
-----------------
Long term results after Ahmed glaucoma valve implantation for uncontrolled glaucoma are retrospectively examined.

Detailed Description
-----------------
The development of intraocular pressure, visual acuity, number of glaucoma medication, number of complications and necessity of revision operations after Ahmed glaucoma valve implantation for uncontrolled glaucoma is examined yearly for a period of 4 years.

Official Title
-----------------
4-year Follow-up After Ahmed Glaucoma Valve Implantation for Lowering Intraocular Pressure in Different Types of Glaucoma

Conditions
-----------------
Glaucoma

Intervention / Treatment
-----------------
* Procedure: Ahmed valve


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients suffering from medically uncontrolled glaucoma Informed consent Exclusion Criteria: healthy subjects under 18 years

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 |
| --- | --- |
| glaucoma, surgery, Ahmed valve<br>Patients with uncontrolled glaucoma undergoing Ahmed glaucoma valve implantation for intraocular pressure reduction. | Procedure: Ahmed valve<br>* The flexible plate 7 (FP7) model (New World Medical) was implanted in patients with uncontrolled glaucoma.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intraocular pressure reduction | The reduction of intraocular pressure after Ahmed glaucoma valve implantation is observed over a period of 4 years. | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| development of visual acuity | The development of visual acuity after Ahmed glaucoma valve implantation is being examined over a period of 4 years. | 4 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
uncontrolled glaucoma, glaucoma drainage device
An Analysis of the Outcomes From Protocolized Perioperative Care for Patients Receiving Total Hip or Knee Arthroplasty

Study Overview
=================
Brief Summary
-----------------
The care for patients receiving total hip and knee arthroplasty at the University of Arkansas for Medical Sciences has followed a structured care pathway since July 2015. This system of perioperative care has focused on preoperative assessment of medical co-morbidities and risks to postoperative functional recovery, anesthetic care focused on postoperative nausea and vomiting prevention and optimizing immediate postoperative functional ability, and aggressive postoperative physical therapy. This is an observational study to look at the outcomes of this program at University of Arkansas for Medical Sciences. Areas of focus will be hospital length of stay, postoperative narcotic consumption, Visual Analog Scale scores, incidence of postoperative nausea and vomiting, and 30-day readmission rates, and health literacy rates.

Official Title
-----------------
An Analysis of the Outcomes From Protocolized Perioperative Care for Patients Receiving Total Hip or Knee Arthroplasty

Conditions
-----------------
Knee Osteoarthritis, Hip Osteoarthritis, Knee Arthritis, Hip Arthritis

Intervention / Treatment
-----------------
* Procedure: Total knee or Hip Arthroplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - All men and women 18 years and older who underwent total hip arthroplasty or total knee arthroplasty surgery at UAMS between 7/01/2015 and 7/01/2016. Exclusion Criteria: - none

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: Total knee or Hip Arthroplasty|Patients who received either a total knee or hip arthroplasty will be identified|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of Stay | Postoperative hospital length of stay | 7/1/2015 - 7/1/2016 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| narcotic consumption | 30-day postoperative narcotic consumption | 7/1/2015 - 7/1/2016 | 
| Pain scores | postoperative VAS pain scores | 7/1/2015 - 7/1/2016 | 
| 30-day readmission | 30-day hospital readmission following procedure | 7/1/2015 - 7/1/2016 | 
| infection | Surgical site infections | 7/1/2015 - 7/1/2016 | 
| PONV | postoperative nausea and vomiting | 7/1/2015 - 7/1/2016 |
Survey Study: Financial Impact of Breast Cancer Treatment

Study Overview
=================
Brief Summary
-----------------
A survey study to evaluate the financial impact of breast cancer as self-reported by breast cancer patients over a period of 1 year. The study will also look at the health insurance literacy and patient's utilization of support services.

Official Title
-----------------
Determining the Financial Impact of Breast Cancer Treatment Over a One Year Period for Patients at a Rural Cancer Center

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Other: Quality of Life Surveys


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or older Diagnosed with breast cancer or a recurrence of breast cancer within the past 2 years Willing to sign consent Able to read and complete surveys in English Exclusion Criteria: Cancer diagnosis other than breast cancer More than 2 years since diagnosis with breast cancer or recurrence

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Quality of Life Surveys|Patients with breast cancer diagnosis complete questionnaires over 20-30 minutes at baseline and at 3, 6, and 12 months after enrollment.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in level of self-reported financial burden | Will evaluate the change in Comprehensive Score for Financial Toxicity (COST-FACIT) measurements from baseline to 1 year follow up. This survey consists of 14 questions related to finances.Responses include 5 options with lower scores representing worse outcomes. Scores at 1 year will be compared to baseline scores. | Baseline through 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in level of self-reported health insurance literacy | Will evaluate the change in Health Insurance Literacy Measurements (HILM) from baseline to 1 year follow up | Baseline through 1 year | 
| Self-reported access and utilization of institutional support services | Will evaluate reported access and utilization of institutional support services and its association to financial burden in the first 12 months after enrollment. | Baseline through 1 year |