linjc16/ctgov huggingface dataset:
Hematopoietic Stem Cell Transplantation in Myeloma

Study Overview
=================
Brief Summary
-----------------
The treatment assignment is based on the presence or absence of an HLA-identical sibling donor (Genetic Randomisation, NOT formal Randomisation). Patients with suitable HLA-identical sibling donors are offered a tandem transplant approach consisting of standard autografting nonmyeloablative radiotherapy and allografting. Patients without HLA-identical siblings are treated with standard double autologous transplantation as per Institutional guidelines or enrolled in other treatment programs approved by local IRBs.This is a multi-center study. The Division of Hematology of University of Torino at the S.G.B. Hospital, Torino, Italy, is the co-ordinating Center.

Conditions
-----------------
Multiple Myeloma

Intervention / Treatment
-----------------
* Procedure: Hematopoietic Stem Cell Transplantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Durie-Salmon stage IIA-IIIB multiple myeloma; Age > 18 and ≤ 65 years; previously untreated myeloma; presence of a sibling (potential donor); bilirubins < twice normal;ALAT and ASAT < four times normal; left ventricular ejection fraction > 40%; creatinine clearances > 40 mL/min; Pulmonary dysfunction with diffusing capacity for carbon monoxide (DLCO) > 40% and/or need for continuous oxygen supplementation; Karnofsky performance status > 60%; patients must give written informed consent; Exclusion Criteria: Age > 65 years previously treated myeloma; absence of a sibling (genetic randomisation cannot be applied); Karnofsky performance status score < 60% HIV-infection; pregnancy; Refusal to use contraceptive techniques during and for 12 months following treatment patients unable to give written informed consent PS. Informed consent is obtained from each patient according to the Institutional Review Boards of the participating centers. The study is conducted according to the Declaration of Helsinki.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Hematopoietic Stem Cell Transplantation|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival Outcomes |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response Rate |  |  | 
| Toxicity |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Multiple Myeloma
A Safety Study of SPX-101 Inhalation Solution in Subjects With Cystic Fibrosis

Study Overview
=================
Brief Summary
-----------------
Ascending dose, 7-day, open label safety trial of SPX-101 Inhalation Solution in adult subjects with cystic fibrosis.

Official Title
-----------------
A Phase 1, Single-Center, Open-Label Safety Study of SPX-101 Inhalation Solution in Subjects With Cystic Fibrosis

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

Intervention / Treatment
-----------------
* Drug: SPX-101


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed diagnosis of CF FEV1 ≥ 40% predicted normal Stable CF lung disease Non-pregnant, non-lactating females Exclusion Criteria: Significant unstable co-morbidities within 28 days of screening as judged by the Investigator. Has received an investigational drug within the past 30 days

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SPX-101 Low Dose<br>Inhalation Solution twice daily for 7 days. | Drug: SPX-101<br>* Inhalation solution twice daily for 7 days.<br>|
| Experimental: SPX-101 Mid Dose<br>Inhalation Solution twice daily for 7 days. | Drug: SPX-101<br>* Inhalation solution twice daily for 7 days.<br>|
| Experimental: SPX-101 High Dose<br>Inhalation Solution twice daily for 7 days. | Drug: SPX-101<br>* Inhalation solution twice daily for 7 days.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events |  | Day 1 through Day 15 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative change from baseline through Day 8 in percent predicted FEV1 |  | Screening and Day 1 through Day 8 | 
| Change from baseline through Day 8 in clinical laboratory tests | Chemistry, Hematology, Urinalysis | Screening and Day 1 through Day 8 |
Native Kidney Denervation in Patients With End Stage Renal Disease

Study Overview
=================
Brief Summary
-----------------
To investigate the utility of renal denervation in the treatment of patients with End Stage Renal Disease (ESRD).

Official Title
-----------------
Native Kidney Denervation in Patients With End Stage Renal Disease

Conditions
-----------------
End Stage Renal Disease

Intervention / Treatment
-----------------
* Device: Ardian Catheter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult >= 18 years of age end stage renal disease, undergoing concurrent dialysis treatment poorly controlled blood pressure on at least 2 antihypertensive drugs agrees to have the study procedure(s) performed and additional procedures and evaluations, including interventions and follow up visits competent and willing to provide written, informed consent to participate in this clinical study. Exclusion Criteria: renal arterial abnormalities myocardial infarction, unstable angina pectoris, or a cerebrovascular accident within six (6) months hemodynamically significant valvular heart disease implantable cardioverter defibrillator (ICD) or pacemaker respiratory support. pregnant, nursing or planning to be pregnant other

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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Ardian Catheter|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To provide confirmation that renal denervation in ESRD patients is safe and feasible. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To provide evidence of denervation, indication of physiologic response, and assess device performance. |  |  |
Follow-up After Surgery for Colon Cancer. General Practice vs. Surgical-based Follow-up?

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to clarify cost effectiveness and quality of life issues among colon cancer patients followed up in a hospital setting or by their GP's.Statement of study hypothesis:Postoperative follow up of colon cancer patients (according to national guidelines) by general practitioners will not have any influence on patients' quality of life. There will not be observed any increase in serious clinical events and cost effectiveness will be improved.

Official Title
-----------------
Should the Surgeon or the General Practitioner (GP) Follow up Patients After Surgery for Colon Cancer? A Randomized Controlled Trial Focusing on Quality of Life, Cost-effectiveness and Serious Clinical Events.

Conditions
-----------------
Colon Cancer

Intervention / Treatment
-----------------
* Other: ca coli follow-up by GP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Surgery for colon cancer (including rectosigmoid) with histological grade Duke stages A, B or C. Completion of postsurgical chemotherapy (Dukes stage C patients). Informed consent. Exclusion Criteria: Patients with rectal cancer defined as cancer within 15 cm from anus. A poor health status or operative complications making it natural to perform follow up by specialists. Additional cancer diagnoses. Disseminated cancer. Poor mental status.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Postoperative follow-up of ca coli patients at the surgical outpatient dpt | Other: ca coli follow-up by GP<br>* patients randomized to follow up by GP<br>|
| Active Comparator: 2<br>Postoperative follow-up of ca coli patients by GP's | Other: ca coli follow-up by GP<br>* patients randomized to follow up by GP<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life; EORTC-QLQ-C30 and EQ 5D |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost-effectiveness Serious clinical events |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Colonic Neoplasms/surgery*, Continuity of Patient Care*, Follow-Up Studies, Quality of Life, Patient Satisfaction
Safety Study of Abatacept in Rheumatoid Arthritis Participants

Study Overview
=================
Brief Summary
-----------------
A observational study to assess whether biologic disease-modifying (BDM) treatment initiation with abatacept for rheumatoid arthritis is associated with an increased risk of serious infection and cancer

Official Title
-----------------
Comparative Safety of Biologic Disease-modifying Treatment Initiation With Abatacept in Rheumatoid Arthritis: A Real-world Population-based Observational Study

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Other: Non-Interventional
* Other: Non-Interventional


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient initiates BDM treatment with at least one claim for the treatment. Patients will be presumed to be new users of a treatment if there is no claim for the drug or any other BDM in the 180 days prior to the cohort entry date Patient has at least two diagnoses for RA in the patient's history prior to and including the entry date or within the 180 days after the entry date Patient is aged 18 years or older on the entry date Patient was enrolled in the database for at least 180 days before the entry date Exclusion Criteria: Patient is younger than 18 years on the entry date Patients who receive abatacept and another biologic simultaneously Patients who have an outcome diagnosis in the baseline period will be excluded from the cohort analyses for that outcome Other protocol defined inclusion/exclusion criteria could apply

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 |
| --- | --- |
| Participants taking abatacept<br> | Other: Non-Interventional<br>* Non-Interventional<br>|
| Participants taking abatacept with methotrexate<br> | Other: Non-Interventional<br>* Non-Interventional<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of increased risk of serious infection while taking abatacept | With methotrexate | Approximately 7 years | 
| Incidence of malignancy while taking abatacept | With methotrexate | Approximately 7 years | 
| Incidence of increased risk of serious infection while taking abatacept | Without methotrexate | Approximately 7 years | 
| Incidence of malignancy while taking abatacept | Without methotrexate | Approximately 7 years |
Comparison of Two Bronchodilator Inhalers in Pediatric Asthmatics

Study Overview
=================
Brief Summary
-----------------
This study is designed to evaluate the single-dose effectiveness of two bronchodilator inhalers given at two dose levels in pediatric asthma patients.

Official Title
-----------------
Dose-ranging Double-blind, Placebo-controlled Efficacy Comparison of Two Bronchodilator Inhalers in Pediatric Asthmatics

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: Bronchodilator


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Persistent asthma for a minimum of six months duration that has been stable for at least four weeks Predicted FEV1 60-90% Demonstration of 12% airway reversibility Exclusion Criteria: Continuous requirement for beta-blockers, monoamine oxidase (MAO) inhibitors, tricyclic antidepressants, anticholinergics and/or steroids other than those inhaled; Presence of clinically-significant non-asthmatic acute or chronic disease

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 11 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: Crossover Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Effect of Intensive Lipid Lowering Treatment Compared to Moderate Lipid Lowering Treatment on Endothelial Function

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to measure the effect of moderate and intensive lipid-lowering treatment with rosuvastatin on the endothelial function.

Official Title
-----------------
Effect of Intensive Lipid Lowering Treatment Compared to Moderate Lipid Lowering Treatment on Endothelial Function

Conditions
-----------------
Atherosclerosis, Endothelial Dysfunction

Intervention / Treatment
-----------------
* Drug: Rosuvastatin 5mg/day
* Drug: Rosuvastatin 40mg/day


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: STEMI no prior treatment with statins Exclusion Criteria: age below 18 or above 81 years unconscious patients serum creatinine > 176μmol/L total-cholesterol > 7.0 mmol/l hypothyreoidism ((TSH > 1.5 x ULN (upper limit of normal)) current liver disease (ALAT > 2 x ULN) unexplained creatine kinase > 3 x ULN alcohol or drug abuse within the last five years prior myopathy or serious hypersensitivity reaction caused by statins women with childbearing potential who were not using chemical or mechanical contraception pregnant or breastfeeding women history of malignancy unless a disease-free period of more than five years was present patients with abnormal lung function test (LFT) participation in another investigational drug study less than four weeks before enrolment in the present study treatment with cyclosporine or fibrates.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 81 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Rosuvastatin 5mg/day<br>Rosuvastatin 5mg/day | Drug: Rosuvastatin 5mg/day<br>* Rosuvastatin 5mg/day<br>* Other names: Crestor;|
| Active Comparator: Rosuvastatin 40mg/day<br>Rosuvastatin 40mg/day | Drug: Rosuvastatin 40mg/day<br>* Rosuvastatin 40mg/day<br>* Other names: Crestor;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change from baseline in endothelium-dependent flow mediated vasodilatation of the brachial artery. |  | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change from baseline in endothelium independent flow mediated vasodilatation of the brachial artery |  | One Year |
Comparing Telepsychiatry and In-person Outcomes

Study Overview
=================
Brief Summary
-----------------
Psychiatric consultation and short-term follow-up will produce equivalent clinical outcomes and be less costly when provided via videoconferencing (telepsychiatry) than when provided in-person.

Detailed Description
-----------------
We predict that patients referred by their family physician for a psychiatric consultation and, if needed, short-term follow-up will have equivalent clinical outcomes when seen via telepsychiatry as compared to those patients seen in-person. We also predicted that telepsychiatry will be cheaper than in-person care.Study Design: a single-centre equivalence trial.We will use a sample size calculation and analytical methods that are specifically tailored for equivalence trials.

Official Title
-----------------
Comparing Patient Outcomes and Cost of Psychiatric Care Provided Through Videoconferencing With Psychiatric Care Provided In-person.

Conditions
-----------------
Psychiatric Disorders

Intervention / Treatment
-----------------
* Device: Videoconference equipment (telepsychiatry)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients referred by their family physicians for psychiatric consultation scores in the dysfunctional range on the Brief Symptom Inventory Exclusion Criteria: patients incapable of consenting to the research patients referred for medico-legal or insurance reports

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Videoconference equipment (telepsychiatry)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brief Symptom Inventory |  |  | 
| Cost of providing the psychiatric services |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life Inventory |  |  | 
| Client Satisfaction Questionnaire |  |  | 
| Hospital Utilization |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Telepsychiatry, Videoconference, Psychiatric consultation, Equivalence trial
Use of Mini-fluid Challenge for Fluid Responsiveness Prediction During One-lung Ventilation

Study Overview
=================
Brief Summary
-----------------
During thoracic surgery, an excessive use of fluid results in pulmonary complications. Dynamic fluid responsiveness predictors are not easily usable during one lung ventilation. The investigators hypothesized that the assessment by transesophageal echocardiography (TEE) of subaortic velocity time index (VTI) variation after 100 ml of crystalloid would predict fluid responsiveness in patients receiving one-lung ventilation. This retrospective, observational, single center study was from January 2014 to December 2015. The investigators included 105 patients requiring one lung ventilation lung resection. The investigators analysed 39 patients presenting an acute circulatory failure. 100 ml of crystalloid was infused over 1-min. After an echocardiographic assessment at 1-min, remaining 400 ml were administered over 14-min Fluid responsiveness was defined as an increase in the VTI above 15% after infusion of 500 ml of crystalloid.

Conditions
-----------------
Acute Circulatory Failure During One-lung Ventilation Surgery

Intervention / Treatment
-----------------
* Other: Fluid challenge
* Other: Trans-oesophageal echography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Lung resection Acute circulatory failure One-lung ventilation Exclusion Criteria: Sinusal rhythm

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 |
| --- | --- |
| one lung ventilation lung<br>patients requiring one lung ventilation lung resection. | Other: Fluid challenge<br>* 100 ml of crystalloid was infused over 1-min<br>Other: Trans-oesophageal echography<br>* an echocardiographic assessment at 1-min,<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fluid responsiveness | increase of cardiac output of more than 15% | one day | 
| Velocity time index | : Echographic assesment of cardiac output | one day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulsed pressure variation | dynamic indice of fluid responsiveness | one day |