linjc16/ctgov huggingface dataset:
PREPARE-IBD: Physician Responses to Disease Flares and Patient Adaptation in Relation to Events in Inflammatory Bowel Disease During COVID-19 Pandemic

Study Overview
=================
Brief Summary
-----------------
To find out what adaptations have been made by Inflammatory bowel disease physicians and patients in relation to therapies in flaring IBD patients during severe acute respiratory syndrome 2-COV and what the impact of these is on IBD patients with no symptomatic COVID-19 and in suspected/confirmed COVID-19. Also whether there any IBD related factors impacting the outcome of patients with COVID-19 symptoms or COVID-19 disease

Detailed Description
-----------------
An observational, retrospective, case-controlled study to determine the status of IBD during development of COVID-19 symptoms/positive COVID-19. The aim is to describe the adaptations in therapies for active IBD during SARS COV 2 in patients with active IBD and positive or negative COVID-19 symptoms. It will evaluate IBD outcomes following development of COVID-19 symptoms / positive COVID-19 and determine any predictors of outcomes in IBD patients with COVID-19 symptoms / positive COVID-19 as well as determine the impact on IBD outcomes resulting from adaptations to treatments during COVID-19

Official Title
-----------------
PREPARE-IBD: Physician Responses to Disease Flares and Patient Adaptation in Relation to Events in Inflammatory Bowel Disease During COVID-19 Pandemic

Conditions
-----------------
Inflammatory Bowel Diseases, Coronavirus Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with IBD +/- flare +/- COVID 19 positivity Exclusion Criteria: Patients below 16 Patient with inactive IBD

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 100 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Admitted patients with IBD (with IBD OR due to COVID) whether tested or not tested for COVID between 1st March and 30th June 2020 | |
| 2<br>Patients with IBD self-isolating with suggestive COVID19 symptoms (Fever or persistent Cough) or tested positive for COVID19 during same period | |
| 3<br>Patients with active IBD identified during the same study period. (definition: increased symptoms suggestive of flare, raised calprotectin, raised CRP, endoscopy or imaging during the previous 6 weeks showing active disease and contacted/reviewed during the study period , admission with IBD ( These will be identified through your helpline/ virtual clinics/Hot clinics/flare lines | |
| Control Group<br>Consecutive patients with active IBD between 1st March 2019-30th June 2019 | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Flare of IBD needing change in therapy or surgery |  | 3 months |
Multiple Breath Nitrogen Washout in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
This study is designed to establish reference values of multiple breath nitrogen washout indexes in an healthy population of volunteers (from childhood to adulthood)

Official Title
-----------------
Multiple Breath Nitrogen Washout in Healthy Volunteers

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

Intervention / Treatment
-----------------
* Procedure: Multiple breath nitrogen washout


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed consent by participant, parent, or legal guardian Healthy subjects with a social insurance Exclusion Criteria: History of a lung chronic disease Premature birth (<37th weeks of amenorrhea) Acute lower respiratory viral infection within 3 weeks before Multiple Breath washout

Ages Eligible for Study
-----------------
Minimum Age: 3 Years

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

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: no treatment, open label<br> | Procedure: Multiple breath nitrogen washout<br>* Lung Clearance Index (LCI) will be performed in healthy volunteers with a multiple breath nitrogen washout device.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lung Clearance Index 2.5% (LCI 2.5%) Value | Multiple breath washout is a pulmonary function test that does not require patients' cooperation. It studies the number of lung volumes (turn-over) to clear a gaz such as nitrogen form the lungs. LCI 2,5 is most frequently reported outcome measure. It corresponds to the sum of the total expired lung volumes needed to decrease the initial gaz concretion to its 1/40th, divided by functional residual capacity. LCI can be measured in infant, preschoolers and thereafter. In order to obtain reproducible tests, three acceptable maneuvers are needed. | hour 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lung Clearance Index 5% (LCI 5%) Value |  | hour 1 | 
| Moment ratio M1/M0 Value |  | up to 1 hour | 
| Moment ratio M0/M2 Value |  | up to 1 hour | 
| Sacin value | assessment of distal areas function | hour 1 | 
| Scond value | assessment of conductive areas function | hour 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lung Clearance Index, Breath Nitrogen Washout, Healthy subjects
A Study for Aggressive Adult T-cell Leukemia-lymphoma (ATLL)

Study Overview
=================
Brief Summary
-----------------
To test the superiority of VCAP-AMP-VECP regimen over biweekly-CHOP in aggressive ATLL in terms of survival benefit.

Detailed Description
-----------------
Nothing to describe.

Official Title
-----------------
Phase III Study of VCAP-AMP-VECP vs. Biweekly CHOP in Aggressive Adult T-cell Leukemia-lymphoma (ATLL): Japan Clinical Oncology Group Study, JCOG9801.

Conditions
-----------------
Adult T-cell Leukemia, Lymphoma

Intervention / Treatment
-----------------
* Drug: VCAP-AMP-VECP with G-CSF and intrathecal prophylaxis
* Drug: biweekly-CHOP with G-CSF and intrathecal prophylaxis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of ATL was made based on seropositivity for HTLV-I by either enzyme-linked immunosorbent assay or particle agglutination assay, and histologically- and/or cytologically-proven peripheral T-cell malignancy Aggressive ATL, i.e., acute-, lymphoma- or unfavorable chronic-type ATL Aged 15-69 years No prior chemotherapy or radiotherapy Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-3 or 4 as a result of hypercalcemia Preserved organ (bone marrow, liver, kidney, heart and lung) functions All patients were required to provide written informed consent Exclusion Criteria: Diabetes mellitus necessitating treatment with insulin Active systemic infection Cardiac disorders expected to become worse as a result of the DOX-containing regimen Acute hepatitis, chronic hepatitis or liver cirrhosis Positive for HBs Ag or anti-HCV Ab Active concurrent malignancy Other serious medical or psychiatric conditions Pregnancy or breast feeding Central nervous system involvement by ATL cells

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 70 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: VCAP-AMP-VECP with G-CSF and intrathecal prophylaxis|nan|
|Drug: biweekly-CHOP with G-CSF and intrathecal prophylaxis|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity |  |  | 
| CR rate |  |  | 
| Progression free survival |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ATLL, chemotherapy, phase III study, VCAP-AMP-VECP, biweekly-CHOP
A Study to Evaluate Safety and Efficacy of NovoSeven® in Patients With Glanzmann's Thrombasthenia in Japan

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Asia. The aim of the study is to evaluate the safety and efficacy of NovoSeven® (activated recombinant factor VII, eptacog alfa (activated)) during bleeding episodes and for the prevention of bleeding during surgery/delivery in patients with Glanzmann's thrombasthenia (GT)/Glanzmann's disease.

Official Title
-----------------
A Multicentre, Non-interventional, Observational Study to Evaluate Safety and Efficacy of NovoSeven® in Patients With Glanzmann's Thrombasthenia in Japan

Conditions
-----------------
Congenital Bleeding Disorder, Glanzmann's Disease

Intervention / Treatment
-----------------
* Drug: eptacog alfa (activated)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed consent obtained before any study-related activities (Study related activity are any procedure related to recording of data according to the protocol). All-treated patients in the registration period Exclusion Criteria: Known or suspected allergy to study product(s) or related products Septicaemia (especially, septicaemia followed severely infected patients caused by gram-negative bacteria [The risk of DIC (disseminated intravascular coagulation) caused by endotoxemia could not denied] Patients with a history of hypersensitivity to any of the product components
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| NovoSeven® (activated recombinant factor VII)<br> | Drug: eptacog alfa (activated)<br>* Patients will be treated according to routine clinical practice at the direction of the treating physician. Data will be collected once a year after patient is registered with baseline visit until end of the study.<br>* Other names: NovoSeven®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Therapy-related thrombosis |  | From onset of treatment until 6 hours after treatment onset | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall efficacy evaluated by the caregiver/patient: effective, partially effective, ineffective or not possible to evaluate |  | Within 30 days of end of treatment for bleeding episodes | 
| Overall efficacy evaluated by the caregiver/patient: effective, partially effective, ineffective or not possible to evaluate |  | Within 24 hours after surgery for surgery/delivery |
Efficacy of a Novel Hemostatic Powder in GI Bleeding

Study Overview
=================
Brief Summary
-----------------
Hemospray™ is a new endoscopic hemostatic powder. Aims of this multicenter prospective study is to determine effectiveness of Hemospray™ on short and medium term in different clinical situations, predictive factors of rebleeding after Hemospray™ application, and feasibility of the application of hemostatic powder in routine clinical practice studying in a large sample of patients.

Official Title
-----------------
A Novel Hemostatic Powder for the Endoscopic Treatment of Gastrointestinal Bleeding: Evaluation of Efficacy, Feasibility and Rebleeding Predictive Factors Results From a Multicenter Prospective Study Performed in Routine Practice

Conditions
-----------------
Gastrointestinal Bleeding

Intervention / Treatment
-----------------
* Other: Non interventional study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female aged 18 and over who need the use of Hemospray® under their care in an emergency. Upper gastrointestinal hemorrhage. Patients who received the information note of the study and agreeing to participate (non-oral opposition gathered in the patient's medical record) Non Inclusion Criteria: Patient under guardianship, curatorship. Pregnant woman.

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: Non interventional study|All upper gastro-intestinal bleeding need endoscopic hemostasis. Endoscopic hemostasis conventional methods are injection of saline with epinephrine, placement of hemoclips and thermic or plasma coagulation. Hemospray™ will be sprayed onto bleeding lesions seen in endoscopy after failure of conventional methods or in salvage therapy at the discretion of endoscopists. Retrospective analysis of prospectively cellected data.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of immediate cessation of bleeding observed in first-line per procedure or after failure of normal hemostasis techniques. | Percentage of immediate cessation of bleeding observed in first-line per procedure or after failure of normal hemostasis techniques. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rebleeding rate at days 8 and 30, defined as the percentage of patients with >2g/dL hemoglobin AND/OR exteriorization of hematemesis AND/OR exteriorization of melena | Rebleeding rate at days 8 and 30, defined as the percentage of patients with >2g/dL hemoglobin AND/OR exteriorization of hematemesis AND/OR exteriorization of melena | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Upper GastroIntestinal bleeding, endoscopy, Hemospray
Evaluation of Childhood Blood Pressure and Lipid Screening

Study Overview
=================
Brief Summary
-----------------
To help clarify the validity, reliability, and utility of blood pressure (BP) and lipid screening in childhood.

Detailed Description
-----------------
BACKGROUND: To be useful, a screening program depends on an acceptable, valid, and reliable test, and an efficacious and cost-effective intervention in the population of interest. Screening children to detect those at high risk of adult hypertension or hypercholesterolemia was examined from this viewpoint. Long-term studies starting in childhood have so far revealed less than optimal validity of blood pressure and serum cholesterol levels in childhood as predictors of adult levels. However, information was sparse regarding reliability of measurements, accounting for which could improve validity. The efficacy of interventions that could be widely applied in childhood had not yet been demonstrated. In addition, the costs of an extensive screening program and risks such as misclassification, side effects, and labeling needed to be evaluated. The results of this study helped determine whether screening for risk factors in childhood was a useful method for preventing cardiovascular disease in adults. DESIGN NARRATIVE: The study examined the following factors that were key elements in the evaluation of screening: 1) within-person variability of BP and lipid measurements (i.e., the reliability of the test) and its impact on tracking of BP and lipids from childhood to adulthood, 2) calculation of predictive values, sensitivity, and specificity of childhood BP and lipid measurements considered as screening tests for adult values, after correcting for within-person variability (i.e., validity), 3) one potentially effective intervention for BP control in children, that is, calcium supplementation, and 4) evaluating the cost-effectiveness of screening to identify children at high risk of developing adult hypertension or hyperlipidemia. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) recor

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

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

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

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

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 Dysphonia in Asthmatic Patients

Study Overview
=================
Brief Summary
-----------------
For many years, it is known that asthmatics have more often dysphonia. However, no study has so far analyzed the reality of dysphonia in asthmatic by making phoniatric tests. The etiology of dysphonia in asthmatic remains controversial. Indeed, for a long time, inhaled corticosteroids have been considered as responsible for organic abnormalities of the vocal cords. We hypothesized that women with asthma have more often dysphonia, and that dysphonia is rather functional origin.

Official Title
-----------------
Evaluation of the Frequency of Dysphonia by Subjective and Objective Methods in Asthmatic Patients

Conditions
-----------------
Asthmatic Patients and Control Group

Intervention / Treatment
-----------------
* Other: Phoniatric tests


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women Aged between 18 to 65 years Patient who signed the informed consent. affiliated with a social security system. Patients with asthma (GINA criteria) - persistent asthma with inhaled corticosteroids.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Female

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: control group<br>the Phonatory Maximum Time Vocal Handicap Index Scale GRBAS of Hirano Videolaryngoscopy | Other: Phoniatric tests<br> <br> * Other names: - Videolaryngoscopy;|
| Experimental: Asthmatic patients<br>The Phonatory Maximum Time Vocal Handicap Index Scale GRBAS of Hirano Videolaryngoscopy | Other: Phoniatric tests<br> <br> * Other names: - Videolaryngoscopy;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evidence of dysphonia. The patient will be considered as having a dysphonia if at least one of the tests (Voice Handicap Index, Rank Rough Breathy Asthenic Strained GRBAS, Quotien Phonatoire QP and Fundamental laryngeal F0) is abnormal |  | Four week |
Intrathecal Prilocaine and Adductor Canal Block vs Intrathecal Bupivacaine Alone for Ambulatory Knee Arthroscopy

Study Overview
=================
Brief Summary
-----------------
- Although bupivacaine is safe and has a low rate of transient neurologic symptoms, the prolonged sensory and motor block is a drawback for day-case spinal anesthesia.Intrathecal hyperbaric prilocaine causes a much shorter motor block, with a similar onset time and lower inter-individual variability in motor block duration. Furthermore, the peripheral nerve block is used as an adjunct to the spinal anesthesia to prolong the surgical anesthetic conditions.

Official Title
-----------------
Hybrid Anesthesia for Ambulatory Knee Arthroscopy Using Intrathecal Prilocaine and Adductor Canal Block vs Intrathecal Bupivacaine Alone: a Randomized Controlled Trial

Conditions
-----------------
Post Operative Pain

Intervention / Treatment
-----------------
* Drug: spinal anesthesia with hyperbaric prilocaine+adductor canal block (ACB) with bupivacaine
* Drug: spinal anesthesia with bupivacaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American Society of Anesthesiologists (ASA) score I-II. Body mass index < 35 kg/m2 Exclusion Criteria: Patient's refusal. Known coagulopathy. Known peripheral neuropathy or neurological deficits. Known allergy to study drugs.

Ages Eligible for Study
-----------------
Minimum Age: 21 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1<br> | Drug: spinal anesthesia with hyperbaric prilocaine+adductor canal block (ACB) with bupivacaine<br>* spinal anesthesia with hyperbaric prilocaine+adductor canal block (ACB) with bupivacaine<br>|
| Active Comparator: Group 2<br> | Drug: spinal anesthesia with bupivacaine<br>* spinal anesthesia with bupivacaine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The duration of motor block (minutes) | The duration of motor block (minutes) | 24 hours postoperatively |