linjc16/ctgov huggingface dataset:
Study of Allogeneic Bone Marrow Transplantation Following Cyclophosphamide and Radiotherapy in Patients With Fanconi's Anemia

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Determine the effectiveness of moderate dose cyclophosphamide and total lymphoid radiotherapy in terms of improving the survival and reducing the morbidity following allogeneic bone marrow transplantation in patients with Fanconi's aplastic anemia.

Detailed Description
-----------------
PROTOCOL OUTLINE: Patients receive cyclophosphamide IV over 2 hours on day -6 through -3 and total lymphoid radiotherapy on day -1. Patients undergo allogeneic bone marrow transplantation on day 0. Patients are followed for at least 100 days.

Conditions
-----------------
Fanconi's Anemia

Intervention / Treatment
-----------------
* Drug: cyclophosphamide
* Procedure: Allogeneic Bone Marrow Transplantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Diagnosis of severe aplastic anemia with the typical phenotype of Fanconi's anemia: Short stature Hypoplastic radii Skin pigmentation Renal anomalies Chromosomal fragility Family history of Fanconi's anemia Histocompatible related donor No evidence of excessive in vitro chromosome fragility typical of Fanconi's anemia Normal CBC and bone marrow

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 54 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: cyclophosphamide|nan|
|Procedure: Allogeneic Bone Marrow Transplantation|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
-----------------
Fanconi's Anemia, aplastic anemia, hematologic disorders, rare disease
COugh Among Hypertensive Patients Treated With Telmisartan, Who Had to Stop previoUs ACE-i Treatment Due to couGH in Slovakia

Study Overview
=================
Brief Summary
-----------------
In the light of ONTARGET and TRANSCEND studies results, it would be interesting to investigate the real-life telmisartan treatment tolerability. It is well known and accepted that the Real-life setting is much more adequate to reflect the antihypertensive and safety properties of the drug in comparison to the organized and scheduled setting of the clinical trial. Because there are not much data on the cough in relation to telmisartan, therefore it would we worth to observe the cough frequency and general treatment tolerance in patients treated with telmisartan, who had to stop their previous ACE-I treatment due to cough.

Official Title
-----------------
Cough Among Hypertensive Patients Treated With Telmisartan, Who Had to Stop Previous ACE-i Treatment Due to Cough

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: Telmisartan (Kinzal/Pritor, BAY68-9291)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hypertension Age > 18 ACE-I related cough Exclusion Criteria: Current treatment with telmisartan Cholestatic disorders and severe hepatic failure Allergy to telmisartan Pregnancy and lactation period

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 |
| --- | --- |
| Group 1<br> | Drug: Telmisartan (Kinzal/Pritor, BAY68-9291)<br>* Patients treated with telmisartan tablets under the real-life setting. Dosing regimen customised to the needs of each participating patient according to the investigators assessment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cough frequency among telmisartan treated patients, who had to stop their previous ACE-I treatment due to cough |  | 4 months after initiation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events among patients, who had to stop their previous ACE-I treatment due to cough |  | 4 months after initiation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cough, Telmisartan, Bradykinin, Tolerability
Phase I Irinotecan, 5-Fluorouracil and Leucovorin Combination

Study Overview
=================
Brief Summary
-----------------
A Phase I open label study to asses the safety and tolerability of ZD6474 in combination with Irinotecan, 5-Fluorouracil and Leucovorin (FOLFIRI) as first or second line therapy in patients with metastatic colorectal adenocarcinoma.

Official Title
-----------------
A Phase I Open Label Study to Asses the Safety and Tolerability of ZD6474 (Vandetanib)in Combination With Irinotecan, 5-Fluorouracil and Leucovorin (FOLFIRI) as First or Second Line Therapy in Patients With Metastatic Colorectal Adenocarcinoma.

Conditions
-----------------
Metastatic, Colorectal, Adenocarcinoma

Intervention / Treatment
-----------------
* Drug: ZD6474 (vandetanib) 100mg
* Drug: Irinotecan
* Drug: 5-Fluorouracil
* Drug: Leucovorin
* Drug: ZD6474 (vandetanib) 300mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed metastatic colorectal adenocarcinoma Not amenable to surgery or radiation therapy Eligible for first or second line chemotherapy Exclusion Criteria: Brain metastases or spinal compression Last prior chemotherapy discontinued within 4 weeks before start Last dose radiotherapy within 4 weeks of start

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ZD6474 (vandetanib) 100mg<br> | Drug: ZD6474 (vandetanib) 100mg<br>* once daily oral tablet<br>* Other names: ZACTIMA™;Drug: Irinotecan<br>* intravenous infusion<br>* Other names: Camptosar®;Drug: 5-Fluorouracil<br>* intravenous infusion<br>* Other names: 5-FU;Drug: Leucovorin<br>* intravenous infusion<br>|
| Experimental: ZD6474 (vandetanib) 300mg<br> | Drug: Irinotecan<br>* intravenous infusion<br>* Other names: Camptosar®;Drug: 5-Fluorouracil<br>* intravenous infusion<br>* Other names: 5-FU;Drug: Leucovorin<br>* intravenous infusion<br>Drug: ZD6474 (vandetanib) 300mg<br>* once daily oral tablet<br>* Other names: ZACTIMA™;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Establish the safety & efficacy of ZD6474 w/5-fluorouracil,leucovorin & oxaliplatin to patients with advanced colorectal adenocarcinoma, by assessment of AEs, vital signs, clinical chemistry, hematology, urinalysis, ECG and physical examinations |  | assessed at each visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ZD6474, Irinotecan, 5-Fluorouracil, Leucovorin, colorectal
Low-dose AZA Combined With Short Term CAG Derived Regimen as a Bridging Treatment in Patients With Advanced MDS Prior to Allo-HSCT

Study Overview
=================
Brief Summary
-----------------
This single arm, prospective study on the feasibility of a bridging treatment with low-dose azacitidine (AZA) in combination with short term CAG derived regimen prior to allogeneic stem cell transplantation (allo-HSCT) in patients with advanced myelodysplastic syndromes (MDS) .

Official Title
-----------------
The Feasibility of a Bridging Treatment With Low-dose Azacitidine (AZA) in Combination With Short Term CAG Derived Regimen Prior to Allogeneic Stem Cell Transplantation (Allo-HSCT) in Patients With Advanced Myelodysplastic Syndromes (MDS)

Conditions
-----------------
MDS-EB

Intervention / Treatment
-----------------
* Drug: Azacitidine
* Drug: CAG Protocol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: New Diagnosed advanced myelodysplastic syndrome (MDS) for whom an allogeneic hematopoietic stem cell transplant is planned Recipient of an allogeneic hematopoietic stem cell transplantation Age < 65 years ECOG performance status ≤2 Written informed consent No psychological, familial, social, or geographic reason that would compromise clinical follow up Exclusion Criteria: Relapsed or refractory advanced MDS Severe pshyciatric or organic disorder, supposed to be independent from advanced MDS, that would contraindicate treatment Known allergic or hypersensitivity to azacitidine, aclarubicin or cytarabine or to any of the test compounds, materials Concurrent, uncontrolled medical condition, laboratory abnormality, or psychiatric illness which could place the subject at unacceptable risk A co-morbid condition which, in the view of the Investigators, renders the subject at high risk from treatment complications

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AZA with CAG derived regimen<br>Azacitidine 50mg/m²/day, D1-D5 (IV) Aclarubicin 5mg/m²/day, D1-D4 (IV) Cytarabine 10mg/m²/12h, D1-D6 (IV) G-CSF 5-10ug/kg/day, D1-D7 (SC) | Drug: Azacitidine<br>* Low-dose AZA<br>Drug: CAG Protocol<br>* Short term CAG derived regimen<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Time to Engraftment |  | Baseline to engraftment, assessed minimally 28 days post transplant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cumulative Incidence of Graft-versus Host Disease |  | Up to 2 years | 
| Incidence of systemic infections |  | Up to 2 years | 
| Overall survival |  | Up to 2 years |
Efficacy/Safety Study of Nebulized IVX-0142, a Novel Antiallergic Drug, in Mild Allergic Asthma

Study Overview
=================
Brief Summary
-----------------
This study is designed to evaluate the effectiveness of nebulized IVX-0142, a novel anti-allergic drug, to inhibit allergen-induced airway narrowing in patients with allergic asthma and the related increased sensitivity of the airways to other substances, as well as to investigate a possible anti-inflammatory effect of the drug in the airways.

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

Intervention / Treatment
-----------------
* Drug: Nebulized IVX-0142


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mild stable allergic asthma Positive skin-prick test to at least one common aeroallergen Positive methacholine challenge Positive allergen-induced early- and late-phase airway bronchoconstriction General good health Exclusion Criteria: Lung diseases other than mild allergic asthma History or symptoms of cardiovascular disease, significant neurologic disease, and/or clinically significant autoimmune disease Chronic use of asthma medications other than short or intermediate beta-agonists or ipratropium Use of tobacco products within one year starting study or smoking history >10 pack years If female, pregnant or lactating or have positive pregnancy test at screening

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Crossover Assignment
Masking: Triple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Nebulized IVX-0142|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serial lung function tests measured up to 7 hours post-allergen challenge to assess effects on early- and late-phase asthmatic reactions |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Methacholine PC20 pre- and post-allergen challenge |  |  | 
| Anti-inflammatory activity in airways |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Allergic asthma, Allergen challenge, Bronchial hyperresponsiveness
TachoSil Versus Standard Surgical Treatment for Air Leakage in Pulmonary Lobectomy (TC-021-IM)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the sealing efficacy and safety of TachoSil® (hereafter referred to as TachoSil) versus standard surgical treatment as the secondary management of intra-operative pulmonary air leakage after a lobectomy in subjects with lung malignancies with or without metastases.

Official Title
-----------------
An Open, Randomised, Prospective, Multi-centre, Parallel-group Trial of TachoSil Versus Standard Surgical Treatment in Patients Undergoing Pulmonary Lobectomy for Lung Malignancy and Requiring Treatment for Air Leakage

Conditions
-----------------
Pulmonary Diseases, Intraoperative Complications

Intervention / Treatment
-----------------
* Drug: Fibrinogen (human) + thrombin (human) (TachoSil)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with a diagnosis of lung malignancy with or without metastases may be included in the trial if the entry criteria apply.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- |
|Drug: Fibrinogen (human) + thrombin (human) (TachoSil)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of post-operative air leakage: assessment on the evening of the day of operation (Day 0) and then subsequently twice daily (on morning and evening shifts) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of intra-operative air leakage intensity after first application of trial treatment |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
standard surgical treatment for air leakage in pulmonary lobectomy
Durability and Tolerability of Infliximab in Pediatric Inflammatory Bowel Disease Patients: A 10 Year Single Center Experience

Study Overview
=================
Brief Summary
-----------------
There is little data published on the long term durability of infliximab in pediatric patients. In particular a focus on durable remission, frequency of dose/frequency change and switch within class. Moreover 10 years of safety experience is rarely reported in children. The overall objective is to evaluate the persistence of infliximab as well as dosing strategies in pediatric inflammatory bowel disease (IBD) patients and safety of infliximab Regarding persistence of infliximab the investigators will be focusing on the proportion of patients who continue to have a durable response or remission to infliximab. The investigators will be assessing this by measuring the frequency of dose escalation, proportion of patients needing frequency change and proportion of patients switched to adalimumab or certolizumab. Safety outcomes will focus on frequency of malignancies, infections and immunogenecity

Conditions
-----------------
Pediatric Inflammatory Bowel Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All individuals who received at least 2 doses of infliximab before the age of 16 at the pediatric IBD Center at Cedars Sinai Medical Center for the treatment of Crohn's disease or ulcerative colitis Able to give consent Exclusion Criteria: not exposed to infliximab

Ages Eligible for Study
-----------------
Maximum Age: 21 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 |
| --- | --- | --- |
| Frequency of patients with a sustained durable remision and frequency of serious infections and malignancies in children exposed to infliximab |  | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of concomitant immunomodulator use in children on infliximab |  | 10 years | 
| Frequency of anti-drug antibodies in patients on and off comcomitant immunomodulators |  | 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pediatric IBD
Alterations in Autonomic Cardiovascular Control Induced at Partial G Forces

Study Overview
=================
Brief Summary
-----------------
As a direct consequence of exposure to microgravity, astronauts experience a number of physiological changes which can lead to serious medical implications. Most immediate and significant is the headward shift of body fluids and the removal of gravitational loading from bone and muscles, resulting in progressive changes of the cardiovascular and musculoskeletal systems. The cardiovascular systems is subject to rapid changes which has been demonstrated in studies of short term (shuttle) and long term missions to Skylab and MIR. Our main hypothesis is that there is a linear relationship between the gravity level (0G, 0.16G, 0.38G, 1G, 1.8G) and the cardiovascular parameters (heart rate (HR), heart rate variability (HRV), blood pressure and blood pressure variability (BPV) as well the spectral analysis of HRV and BPV.

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Other: Parabolic flight
* Other: Cardiovascular parameters measurements


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy male volunteer aged from 20 to 35 affiliated to a Social Security system and, for non-French resident, holding an European Health Insurance Card (EHIC) who accepts to take part in the study who has given their written stated consent who has passed a medical examination similar to a standard aviation medical examination for private pilot aptitude .There will be no additional test Exclusion Criteria: persons who took part in a previous biomedical research protocol, of which exclusion period is not terminated, persons who take any medication or drugs influencing the autonomic cardiovascular control

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 35 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Cardiovascular parameters measurements<br> | Other: Parabolic flight<br> <br> Other: Cardiovascular parameters measurements<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The heart rate (HR) and the heart rate variability (HRV) derived from the ECG |  | baseline | 
| The systolic, diastolic and mean arterial blood pressure (SP, DP, MAP) |  | baseline | 
| The autonomic cardiovascular control evaluated with a spectral analysis of HRV and BPV. |  | baseline | 
| the blood pressure variability (BPV) derived from the continuous blood pressure recording |  | baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
volunteers