linjc16/ctgov huggingface dataset:
MicroCutter Assisted Thoracic Surgery Hemostasis Registry

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this prospective, open-label, multi-center observational registry with all-comers enrollment is to report on the use of the MicroCutter Stapler in a real world setting in thoracic surgical procedures. Procedures may be open or video assisted thoracic surgery (VATS) including robotic surgical cases. Clinicians will provide objective and subjective evaluation of the use of the stapler in their procedures.

Detailed Description
-----------------
The MATCH registry is a prospective, open label, multi-center observational registry with enrollment of patients requiring surgical stapling during a lobectomy or segmentectomy. Patients will be treated per the clinicians standard of care with medical history and demographic data collected pre-procedure, operative data including clinician's objective and subjective evaluation of the stapler and confirmation of any complications via query and data collection at hospital discharge and each clinician's standard post-operative contact.

Official Title
-----------------
MicroCutter Assisted Thoracic Surgery Hemostasis Registry

Conditions
-----------------
Lobectomy, Segmentectomy

Intervention / Treatment
-----------------
* Device: Surgical Stapler


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing lobectomy/segmentectomy in which the MicroCutter Stapler and Reloads were used. Patient is willing and able to sign informed consent form to participate in registry, allowing for collection of data. Exclusion Criteria: Clinician determines no vessels are suitable for the on label use of the MicroCutter Stapler and Reloads.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Surgical Stapler|Patients in whom the MicroCutter stapler was used during a thoracic surgical procedure.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemostasis of vessel staple line | Objective classification of hemostasis achieved by the MicroCutter Stapler used on label using a Likert like scale; from 1 (no bleeding) to 5 (bleeding requiring conversion to open procedure or discovered post operatively) | through study completion, approximately 1 month |
Genetic Study of Patients and Families With Diaphyseal Medullary Stenosis With Malignant Fibrous Histiocytoma of the Bone

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Identify and characterize the gene causing diaphyseal medullary stenosis with malignant fibrous histiocytoma of the bone. II. Determine the clinical manifestations of this disease in these patients.

Detailed Description
-----------------
PROTOCOL OUTLINE: Blood samples are obtained from affected individuals and their family members after genetic counseling. Genetic linkage analysis is performed on these blood samples. Unaffected individuals undergo x-rays and technetium bone scans to detect the presence of bone disease. Affected individuals undergo bone densitometry, MRI studies, thallium scans, ophthalmologic examination, electrocardiogram, echocardiogram, and skin biopsies. Affected family members identified after radiologic studies receive additional genetic counseling.

Conditions
-----------------
Stenosis, Histiocytoma

Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Diagnosis of diaphyseal medullary stenosis with malignant fibrous histiocytoma of the bone OR Family member, including spouses, of an affected individual --Patient Characteristics-- Renal: Not specified Not pregnant Negative pregnancy test No diminished mental capacity No prisoners

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 90 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
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
-----------------
bone cancer, arthritis & connective tissue diseases, diaphyseal medullary stenosis, genetic diseases and dysmorphic syndromes, malignant fibrous histiocytoma of bone, musculoskeletal/mesodermal cancer, oncologic disorders, rare disease
Atelectasis During Delivery - Comparing Cesarian (c) -Section and Labor

Study Overview
=================
Brief Summary
-----------------
Pregnancy promotes respiratory system's restrictive component. This study observes the generation of atelectasis during labor.

Detailed Description
-----------------
Pregnancy causes restriction of diaphragm movements as well as higher resistive component to the respiratory system. Spirometry studies have shown that the supine position increases risks of hypoxemia. There seems to be only casual observation regarding the generation of atelectasis during labor.

Official Title
-----------------
CT Study of Atelectasis After Delivery - Comparison Between Cesarian Section and Labor

Conditions
-----------------
Delivery, Obstetric, Cesarean Section, Labor, Respiration Disorders, Atelectasis

Intervention / Treatment
-----------------
* Radiation: CT scan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: post-anesthesia recovery Exclusion Criteria: hemodynamic disorder during labor

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PN<br>Control - Induced or natural labor under anesthesia | Radiation: CT scan<br>* Thoracic CT scan<br>|
| PC<br>Case - Cesarean section under anesthesia | Radiation: CT scan<br>* Thoracic CT scan<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| atelectasis |  | 60-120 minutes after delivery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Delivery, obstetric, Atelectasis
A Study of NeoRecormon (Epoetin Beta) in Patients With Renal Anemia.

Study Overview
=================
Brief Summary
-----------------
This study will determine whether 8 weekly monitoring of hemoglobin and iron parameters in the correction phase of NeoRecormon therapy in patients with renal anemia is as safe and effective as 4 weekly monitoring. Patients with chronic kidney disease will receive NeoRecormon at a dose aimed at achieving and maintaining a Hb level of 110-130g/L. They will be randomized into one of two schedules for monitoring hemoglobin levels and iron parameters, either 4 weekly or 8 weekly. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 inidividuals.

Official Title
-----------------
A Randomized Study to Compare the Safety and Effectiveness of Two Monitoring Schedules to Maintain Hemoglobin Levels and Iron Parameters in Patients With Renal Anemia Receiving NeoRecormon

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

Intervention / Treatment
-----------------
* Drug: epoetin beta [NeoRecormon]


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients, 18-80 years of age; stage 3-4 chronic kidney disease (eGFR 15-60mL/min); Hb <100g/L, TSAT>=20%, and ferritin >=100 mcg/L at screening. Exclusion Criteria: anticipating to go on renal replacement therapy; anticipating a living related-donor kidney transplant, or a prior recipient of a kidney transplant; uncontrolled hypertension; congestive heart failure; active bleeding or red blood cell transfusions in 8 weeks prior to screening; systematic hematological disease.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: epoetin beta [NeoRecormon]|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients achieving target Hb within 20 weeks. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: % of patients exceeding upper Hb target; % who fail to reach target Hb; median time to achieve Hb target; dose of NeoRecormon required to meet target Hb concentration; % who maintain target iron parameters. Safety: AEs, SAEs. |  |  |
Proteomics to Identify Prognostic Markers After CPR and to Estimate Neurological Outcome

Study Overview
=================
Brief Summary
-----------------
Proteomics is used to identify prognostic markers after CPR. Additionally neurological outcome should be estimated by specific protein alterations and affections of pathways.

Detailed Description
-----------------
Proteomics is used to identify prognostic markers after CPR, i.e. altered proteins on a 2G-gel. Additionally neurological outcome should be estimated by specific protein alterations and affections of pathways.

Official Title
-----------------
Proteomics to Identify Prognostic Markers After CPR and to Estimate Neurological Outcome

Conditions
-----------------
Cardiac Arrest

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cardiac arrest Exclusion Criteria: trauma

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 |
| --- | --- |
| dead<br>Patients dead until day 20 (primary outcome measure) | |
| survivors<br>patients alive after day 20 (primary outcome measure) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| death at day 20 |  | day 20 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CPR
Intraocular Pressure Fluctuation in Patients With Glaucoma and in Healthy Patients During Standard Yoga Positions

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to investigate the IOP difference between normal and glaucomatous eyes using standard ophthalmic tonometry devices while subjects are performing different standard yoga asanas. The IOP of participants will be measured prior, immediately at start of the asana, 2 minutes into the asana, and immediately after assuming a sitting position. The patient will wait 10 minutes and a final IOP will be taken. Four standard yoga asanas will be tested.

Official Title
-----------------
Intraocular Pressure Fluctuation in Patients With Glaucoma and in Healthy Patients During Standard Yoga Positions

Conditions
-----------------
Glaucoma, Intraocular Pressure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Glaucoma or healthy control Practice yoga 18-80 years old Practice Yoga for a minimum of 12 months Exclusion Criteria: Healthy subjects do not have normal ophthalmic exam Cannot maintain yoga positions

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Glaucoma<br> | |
| Control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Intraocular Pressure |  | Change from Baseline, Immediate, 2 Minutes, Post, 10 min Post |
Follow-up Efficacy and Safety of Alitretinoin in Severe Chronic Hand Dermatitis

Study Overview
=================
Brief Summary
-----------------
Patients who have been treated in study protocol BAP089 may have responded to treatment, and subsequently relapsed to >75% of the baseline disease severity, will be investigated for response to further treatment with alitretinoin. Also, patients who have responded with mild or moderate disease will be investigated for additional treatment effect after prolongated treatment.

Official Title
-----------------
Follow up Efficacy and Safety Study of BAL4979 in the Treatment of Chronic Hand Dermatitis Refractory to Topical Treatment

Conditions
-----------------
Hand Dermatoses

Intervention / Treatment
-----------------
* Drug: alitretinoin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Previous participation in protocol BAP089 Response of severe, treatment refractory hand dermatitis with mild or moderate, or responding patients who relapsed to 75% of baseline disease Exclusion Criteria: Female patients who are pregnant or who want to become pregnant Female patients of child bearing potential who cannot use or who will not commit to using two effective methods of contraception

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response of chronic hand dermatitis to study treatment as assessed by Physicians Global Assessment, at week 12 or 24 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient's global assessment |  |  | 
| Extent of disease |  |  | 
| Time to respond |  |  | 
| Modified total lesion symptom score |  |  | 
| at week 12 or 24 |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Patients who have been enrolled in study protocol BAP089, and whose severe chronic hand dermatitis responded with mild or moderate disease, or who relapsed
A Study to Evaluate the Efficacy and Safety of CT-P27 in Acute Uncomplicated Influenza A Infection

Study Overview
=================
Brief Summary
-----------------
This study is a Phase IIb, Randomized, Double-blind, Multicenter, Placebo-controlled study evaluating the efficacy and safety of CT-P27 in subjects with acute uncomplicated influenza A infection.

Detailed Description
-----------------
This study is a Phase IIb, Randomized, Double-blind, Multicenter, Placebo-controlled study. All enrolled subjects will be given a single dose of 90 mg/kg CT-P27, 45 mg/kg CT-P27, or placebo intravenously over 90 minutes (±15 minutes) on Day 1 and then followed by Day 110.

Official Title
-----------------
A Phase IIb, Randomized, Double-blind, Multicenter, Placebo-controlled Study Evaluating the Efficacy and Safety of CT-P27 in Subjects With Acute Uncomplicated Influenza A Infection

Conditions
-----------------
Influenza A

Intervention / Treatment
-----------------
* Drug: CT-P27 90 mg/kg
* Drug: CT-P27 45 mg/kg
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or Female subjects between the ages of 19 and 64 years, both inclusive Diagnosed with influenza A at screening using rapid influenza diagnostic test Onset of influenza symptoms and fever is within 48 hours at screening At least 2 of symptoms (moderate to severe in intensity) ≥38.0'C body temperature at screening Exclusion Criteria: Taking antiviral treatment for influenza or has a history of using these antivirals within 14 days prior to the administration of study drug Positive influenza B or A+B infection

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 64 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CT-P27 90 mg/kg<br>CT-P27 will be administrated once in IV infusion. | Drug: CT-P27 90 mg/kg<br>* Influenza A treatment drug.<br>* Other names: CT-P27;|
| Experimental: CT-P27 45mg/kg<br>CT-P27 will be administrated once in IV infusion. | Drug: CT-P27 45 mg/kg<br>* Influenza A treatment drug.<br>* Other names: CT-P27;|
| Placebo Comparator: Placebo<br>Placebo will be administrated once in IV infusion. | Drug: Placebo<br>* Placebo.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Resolution of Influenza Symptoms and Fever | Time to resolution of influenza symptoms (cough, sore throat, nasal congestion, headache, feeling feverish, body aches and pains, and fatigue) and fever (<37.8) | Twice a day (Morning and Evening) from Day 1 to Day 8 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
efficacy, safety
Immunogenicity of One Dose of Gardasil and One Dose of Gardasil-9

Study Overview
=================
Brief Summary
-----------------
This study will assess the immunogenicity of one dose of Gardasil and one dose of Gardasil-9

Detailed Description
-----------------
This is a one group exploratory study. The main objective of this study is to assess the persistance of anti-HPV after a single dose Gardasil and the effect of one dose of Gardasil-9 when administered 3-8 years later.

Official Title
-----------------
Persistance of Anti-HPV After a Single Dose of Gardasil and the Effect of a Dose of Gardasil-9 When Administered 3-8 Years Later

Conditions
-----------------
Human Papillomavirus Vaccines

Intervention / Treatment
-----------------
* Biological: Gardasil and Gardasil-9


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have received a single dose of Gardasil 3-8 years before recruitement. - Exclusion Criteria: Immunossupressed or blood coagulation problems -

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 18 Years

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

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

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

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: Single group exploratory study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gardasil and Gardasil-9<br> | Biological: Gardasil and Gardasil-9<br>* All subjects will receive one dose of Gardasil-9. Blodd samples for serological testing will be collected just before and one month post Gardasil-9 administration.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-HPV seropositivity | Seropositivity to 9 HPV types included in Gardasil-9 vaccine will be assessed. | One month post vaccine administration. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HPV antibody titers | Geometrical mean titers of antibodies to 9 HPV types included in Gardasil-9 vaccine will be assessed | One month post vaccine administration |
Development of Obesity and Bariatric Surgery

Study Overview
=================
Brief Summary
-----------------
This study focus on the cause of obesity and impacts of bariatric surgery on it.

Official Title
-----------------
Impacts of Bariatric Surgery on Obesity in China

Conditions
-----------------
Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body mass index ≥18 kg/m2 already received bariatric surgery or abdonimal surgery Exclusion Criteria: acute stroke or acute myocardial infarction in 6 months autoimmune disease long-term use of non-steroidal anti-inflammatory drugs, corticosteroids and immunosuppressive drugs pregnancy consists with other endocrine diseases acute infection in2 weeks cancer use of antibiotics in 3 months chronic digestive inflammations 9

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| Obesity<br>Patients with obesity already received bariatric surgery | |
| Healthy control<br>Volunteers with normal body weight and already received abdominal surgery | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunity cells | Ratio of immunity cells in circulating and adipose or liver tissue | up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight and height | Body weight and height will be combined to report BMI in kg/m^2 | up to 5 years | 
| Insulin | Insulin (mIU/L) concentartions in serum and adipose tissue | up to 5 years | 
| Cytokine | Cytokines concentrations in circulating and adipose or liver tissue | up to 5 years | 

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