linjc16/ctgov huggingface dataset:
Contribution of Drug Induced Sleep Endoscopy of Pediatric Obstructive Sleep Apnea Hypopnea Syndrome

Study Overview
=================
Brief Summary
-----------------
The role of drug-induced sleep endoscopy (DISE) in the management of obstructive sleep apnea hypopnea syndrome (OSAHS) is not precisely defined for children. The primary objective of this study was to describe the consequences of DISE in the therapeutic management for children with OSAHS. The secondary objectives were to analyze the correlation between the number of obstructive sites found during DISE, the value of apnea-hypopnea index (AHI), and the type of OSAHS.

Detailed Description
-----------------
Retrospective single center study of 31 children (mean age: 5.5 ± 2.6 years) who benefited from DISE between 2015 and 2018 in the management of OSAHS. Modification of therapeutic management was noted. A correlation between the number of obstructive sites and the IAH on the one hand, and between the number of obstructive sites and the type of SAHOS on the other hand, was sought.

Official Title
-----------------
Contribution of Drug Induced Sleep Endoscopy in the Management of Pediatric Obstructive Sleep Apnea Hypopnea Syndrome

Conditions
-----------------
Obstructive Sleep Apnea Hypopnea Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: - OSAHS confirmed by overnight sleep monitoring (respiratory polygraphy or overnight polysomnography) Exclusion criteria: - Lack of data

Ages Eligible for Study
-----------------
Maximum Age: 12 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 |
| --- | --- | --- |
| sleep endoscopy | describe the modification of therapeutic management induced by sleep endoscopy | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of obstructive site during | retrospective data collection : Number of obstructive site during | 1 day | 
| value of apnea-hypopnea index | retrospective data collection : value of apnea-hypopnea index | 1 day | 
| type obstructive hypopnoea apnea syndrome of sleep | type obstructive hypopnoea apnea syndrome of sleep. Children facing craniofacial or neuromuscular disorders were rated in Type III OSAHS. Obese children were rated in Type II OSAHS. Others children were rated by default in Type I OSAHS. | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
drug-induced sleep endoscopy, pediatric obstructive sleep apnea hypopnea syndrome, tongue base, epiglottis, occult laryngomalacia, lingual tonsillectomy, epiglottopexy, aryepiglottic folds division
Oral Carvedilol in Escalating Doses in the Acute Treatment of Atrial Fibrillation

Study Overview
=================
Brief Summary
-----------------
Oral carvedilol administered in escalating doses in patients with atrial fibrillation among patients with AF with fast ventricular rate.

Detailed Description
-----------------
Patients with AF with FVR of any etiology were evaluated and given escalating doses of oral carvedilol in doses - 3.125mg OD, then 3.125 bid, then 6.25mg bid, then 12.5mg bid. The ECG was recorded regularly and analysed for rate reduction or control.

Official Title
-----------------
Oral Carvedilol in Escalating Doses in the Acute Treatment of Atrial Fibrillation

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Drug: oral carvedilol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: AF with fast ventricular rate Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: active arm<br>single arm study with one group given oral carvedilol. | Drug: oral carvedilol<br>* oral carvedilol in escalating doses for reducing ventricular rate in AF patients<br>* Other names: oral carvedilol in esclating doses;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reduction in ventricular rate in AF patients | reduction in ventricular rate in patients with AF and fast ventricular rate. | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
atrial fibrillation, rate reduction
RBC Transfusion in Severe Anemia With Lactic Acidosis

Study Overview
=================
Brief Summary
-----------------
The hypothesis of this study is that prolonged-storage RBCs are not inferior to short-storage RBCs for the time required to clear elevated blood lactate levels in children with severe anemia.

Detailed Description
-----------------
This study will measure the time to resolution of lactic acidosis in patients with severe anemia following blood transfusion.

Official Title
-----------------
A Prospective Study of RBC Transfusion in Children With Severe Anemia

Conditions
-----------------
Anemia

Intervention / Treatment
-----------------
* Biological: RBC transfusion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 6 mos to 5 years Hg < 5 g/dL and Lactate > 5 mM Exclusion Criteria: Receiving transfusion other than RBCs Children with known or suspected cardiac disease

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 5 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 |
| --- | --- |
| Active Comparator: Short-storage RBC<br>RBC transfusion using packed RBCs stored for 10 days or less. | Biological: RBC transfusion<br>* RBC transfusion of different storage age<br>|
| Active Comparator: Prolonged-storage RBC<br>RBC transfusion using packed RBCs stored for 25 days or more. | Biological: RBC transfusion<br>* RBC transfusion of different storage age<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of elevated levels of blood lactate during 24 following RBC transfusion |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Normalization of vital signs |  | 24 hours | 
| Correction of acidosis |  | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anemia, Transfusion, RBC storage age, Tissue oxygenation, Malaria
Absolute Bioavailability of BMS-626529 After Oral and Intravenous Dosing

Study Overview
=================
Brief Summary
-----------------
A phase I absolute bioavailability study of BMS-626529 following oral and intravenous dosing

Official Title
-----------------
Study of the Absolute Bioavailability of BMS-626529 in Healthy Subjects Following Oral Dosing of BMS-663068 and Intravenous Dosing of BMS-626529

Conditions
-----------------
Infection, Human Immunodeficiency Virus

Intervention / Treatment
-----------------
* Drug: BMS-663068
* Drug: BMS-626529


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Generally healthy BMI 18.0-32.0 kg/m2 Men sexually active with women of childbearing potential must follow instructions for contraception for the duration of treatment plus 90 days Men must refrain from sperm donation for the length of the study and for 90 days Sign informed consent Exclusion Criteria: Significant medical illness Tobacco use in the last 12 months Major surgery within 4 weeks of study administration Donation of blood within 4 weeks of study administration Current or recent (within 3 months of study administration) of gastrointestinal disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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: Oral dose of BMS-663068 + intravenous dose of [13C]BMS 626529<br>Single oral dose of BMS-663068 followed by Single intravenous dose of [13C]BMS 626529 | Drug: BMS-663068<br>* Single oral dose of BMS-663068<br>Drug: BMS-626529<br>* Single intravenous dose of [13C]BMS 626529<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The absolute bioavailability of BMS-626529 after single oral (BMS-663068) and single intravenous dosing ([13C]-BMS-626529) by assessing the primary endpoints AUC(inf) |  | up to 11 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability of single oral dose of BMS-663068 as determined by medical review of adverse event reports, vital sign measurements, electrocardiograms (ECGs), and results of physical examination and laboratory tests |  | up to 31 days | 
| Safety and tolerability of single intravenous dose of [13C]-BMS-626529 as determined by medical review of adverse event reports, vital sign measurements, electrocardiograms (ECGs), and results of physical examination and laboratory tests |  | up to 31 days |
Study of SGN-40 in Patients With Relapsed Diffuse Large B-Cell Lymphoma

Study Overview
=================
Brief Summary
-----------------
This is a Phase II, open-label, multidose trial of SGN-40 designed to estimate objective response rate and assess toxicity in patients with relapsed DLBCL.

Official Title
-----------------
A Phase II Study of SGN-40 (Anti-huCD40 mAb) in Patients With Relapsed Diffuse Large B-Cell Lymphoma (DLBCL)

Conditions
-----------------
Lymphoma, Large B-Cell, Diffuse, Lymphoma, Non-Hodgkin

Intervention / Treatment
-----------------
* Drug: SGN-40


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of DLBCL. Received at least one combination chemotherapy regimen with rituximab, such as R-CHOP, R-ESHAP or equivalent. Progression or relapse since most recent therapy. At least one measurable lesion that is both greater than or equal to 2 cm by conventional CT or greater than or equal to 1.5 cm by spiral CT. Exclusion Criteria: Previous diagnosis or treatment for indolent lymphoma, leptomeningeal lymphoma, or central nervous system lymphoma. Primary refractory disease. Received an allogenic stem cell transplant.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: SGN-40<br>* 1-8 mg/kg IV (in the vein) on Days 1, 4, 8, 15, 22 and 29 of Cycle 1; 8 mg/kg IV (in the vein) on Days 1, 8, 15, and 22 for Cycles 2-12.<br>* Other names: dacetuzumab;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response as assessed by CT and PET scans and revised response criteria for malignant lymphoma. |  | Every 1 or 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival, disease-free survival, and overall survival. |  | Study duration | 
| Adverse events, laboratory values, and anti-drug antibody immune responses. |  | Within 3 weeks of final infusion | 
| PK profile. |  | Within 3 weeks of final infusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Antigens, CD40, Antibody, Monoclonal, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Non-Hodgkin, Hematologic Diseases, Immunoproliferative Disorders, Lymphatic Diseases, Lymphoproliferative Disorders, Lymphoma
Epidrum for Thoracic Epidural Analgesia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the use of the Epidrum device to identify the epidural space in patients requiring thoracic epidural analgesia.

Official Title
-----------------
A Comparison Study of Two Different Techniques for Identifying the Epidural Space in Patients Requiring Thoracic Epidural Analgesia: a Prospective Multicentric Randomized Study

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

Intervention / Treatment
-----------------
* Device: Epidural catheter placement
* Procedure: Epidural catheter placement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elective major thoracic surgery requiring thoracic epidural analgesia Exclusion Criteria: Contraindication to epidural anesthesia Marked spinal deformities or a history of spinal instrumentation

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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Epidrum<br>Epidrum (Exmoor Innovations, Lisieux Way, Taunton, Somerset TA1 2LB, U.K.) | Device: Epidural catheter placement<br>* Epidural space is located using Epidrum (Exmoor Innovations, Lisieux Way, Taunton, Somerset TA1 2LB, U.K.)<br>|
| Active Comparator: Loss of resistance technique<br> | Procedure: Epidural catheter placement<br>* Epidural space is located using loss of resistance technique (saline solution)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ease to identify the epidural space | Number of cases having required more than 2 punctures and number of failures of the technique | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of epidural procedure |  | 30 minutes | 
| Number of cutaneous punctures |  | 30 minutes | 
| Number of needle redirections |  | 30 minutes | 
| Ease of epidural catheter insertion |  | 30 minutes | 
| Number of inadequate postoperative analgesia | asymmetric, incomplete or failed analgesia | one day after anesthesia |
Anlotinib for Hepatocellular Carcinoma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to observe and explore the effect of single or combined treatment of arotinib on the survival and prognosis of patients with advanced liver cancer in the real world, and to summarize the treatment experience of a wide range of people.

Official Title
-----------------
A Real World Study on the Effect of Single or Combined Treatment of Anlotinib on Survival and Prognosis of Advanced Hepatocellular Carcinoma

Conditions
-----------------
Liver Neoplasms

Intervention / Treatment
-----------------
* Drug: Anlotinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: ≥ 18 years old, male or female; Patients with advanced liver cancer were diagnosed; Patients assessed by doctors to benefit from single or combined treatment of arotinib; Patients volunteered to join the project. Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Anlotinib|This is an observational study|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OS | Overall Survival | From date of admission until the date of death from any cause, assessed up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | Progression Free Survival | From date of admission until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months |
Work-related Respiratory Symptoms in Champagne Vineyard Workers

Study Overview
=================
Brief Summary
-----------------
Work related asthma and rhinitis are frequent diseases with a significant morbidity and a social and economic impact. Farmers are highly exposed to various inhaled agents such as organic or inorganic dust, endotoxin, micro-organisms, pollen, mites, moulds, animal danders and pesticides, inducing rhinitis, asthma, chronic bronchitis, hypersensitivity pneumonitis and organic dust toxic syndrome. Work related respiratory symptoms are frequent in crop farmers. Allergic rhinitis and respiratory symptoms in fruit farmers are mainly related to pollen allergy, especially gramineae pollen. They can also be related to the use of pesticides or exposure to mites .

Detailed Description
-----------------
Aim of the study were : to determine the prevalence of work related respiratory symptoms in workers of Champagne vineyard in France to analyze the relationships between respiratory symptoms, occupational exposure and sensitization profile in workers of Champagne vineyard in France

Official Title
-----------------
Work-related Respiratory Symptoms in Champagne Vineyard Workers

Conditions
-----------------
Respiratory Symptoms

Intervention / Treatment
-----------------
* Other: Allergy and respiratory functional tests


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: workers of Champagne vineyard aged > 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 |
| --- | --- |
| workers of Champagne vineyard<br> | Other: Allergy and respiratory functional tests<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitization | A positive skin prick test was defined as the presence of a mean wheal diameter of 3 mm or more than the negative control. Sensitization was defined by a positive skin reaction to one or more allergens | Day 0 |
Effect of a Nutritional Supplement on H&N Cancer Patients

Study Overview
=================
Brief Summary
-----------------
To determine if using a nutritionally enhanced supplement will improve mucositis in head and neck cancer patients

Detailed Description
-----------------
H&N cancer patients will be randomized to receive either a nutritionally enhanced product or standard treatment. The patients in both groups will receive nutritional counseling weekly by the RD. Anthropometric measures, available lab values, mucositis grade, and quality of life measures will be compared between groups.

Official Title
-----------------
The Effect of an Enhanced Nutritional Supplement on Head and Neck Cancer Patients

Conditions
-----------------
Head and Neck Cancer

Intervention / Treatment
-----------------
* Behavioral: behavior


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Head and neck cancer 1st.2nd wk Rx read &wrte eng Exclusion Criteria: receiving hospice impaired cognition

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 80 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: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: behavior|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| severity of mucositis |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight loss, quality of life |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cancer, nutrition