linjc16/ctgov huggingface dataset:
Interscalene Brachial Plexus Block to Treat Pain After Clavicular Surgery

Study Overview
=================
Brief Summary
-----------------
The sensory innervation of the clavicle remains an area of debate. Regional nerve blocks aimed at relieving pre- and post-operative pain include the superficial cervical plexus blocks, interscalene blocks and a combined version of the above. In this case study, the investigators aim to describe the protocol used in a university hospital: general anaesthesia with interscalene brachial plexus block, followed by optional iv morphine administration in phase 1 recovery and oral oxycodone on the ward.

Official Title
-----------------
Interscalene Brachial Plexus Block to Treat Pain After Clavicular Surgery

Conditions
-----------------
Acute Pain

Intervention / Treatment
-----------------
* Procedure: Interscalene brachial plexus block


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clavicular fracture with internal reduction physical status I - III Exclusion Criteria: contraindication to regional anaesthesia history of neck radiotherapy patient suffering from chronic pain severe respiratory disease

Ages Eligible for Study
-----------------
Minimum Age: 18 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interscalene brachial plexus block<br> | Procedure: Interscalene brachial plexus block<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IV Morphine consumption in phase 1 recovery (mg) | morphine administered in postanaesthetic care unit by nursers if pains score > 3/10, per protocol | 0-2 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain scores at rest and on movement (numeric rating scale, 0-10) |  | Postoperative day 0 and 1 | 
| Postoperative nausea and vomiting (yes/no) |  | Postoperative day 0 and 1 | 
| Itching (yes/no) |  | Postoperative day 0 and 1 | 
| Cumulative oxycodone consumption (mg) |  | up to postoperative day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Clavicle
Study for HER2-Overexpressed MBC Patients Treated by Cipterbin® Plus vinorelbinE

Study Overview
=================
Brief Summary
-----------------
Breast cancer is the most common malignant disease and the most frequent causes of cancer mortality in females worldwide. The situation is same as the world in China. Trastuzumab has been proved valuable treatment for HER2-positive breast cancer patients. Cipterbin® is developing by Shanghai CP Guojian Pharmaceutical Co.Ltd.Now we carried on the phase III trial in order to prove Cipterbin® 's efficacy and safety.

Official Title
-----------------
A Phase III Randomized Study for HER2-Overexpressed Metastatic Breast Cancer Patients Treated by Trastuzumab( Cipterbin®) Plus vinorelbinE Simultaneously or Sequencely

Conditions
-----------------
Progress-free Survival, Overall Response Rate, Adverse Events

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: signed ICF pathologic diagnosis breast cancer HER2+ status defined as IHC3+ Staining or in situ hybridization positive at least 1 measurable lesion as per RECIST criteria age from 18y to 70y KPS>=70 Exclusion Criteria: More than three prior chemotherapy lines for advanced disease LVEF<50% prior exposure vinorebine for breast cancer prior exposure Trastuzumab for breast cancer uncontrolled brain metastasis breastfeeding or pregnant

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- | --- |
| progress-free survival |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall response rate,safety |  |  |
Expression of HOXA10 and HOXA11 in the Endometrium of Infertility Patients With an Endometrial Polyp Before and After Polypectomy

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to measure the expression of HOXA10 and HOXA11 in the endometrium of infertility patients with an endometrial polyp before and after polypectomy. HOXA10 and HOXA11 are well-established markers of implantation. It is uncertain as to whether an endometrial polyp interferes with embryo implantation. A higher expression of HOXA10 and HOXA11 after polypectomy can indicate that endometrial polyp does interfere with embryo implantation.

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Procedure: Endometrial biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infertile women with endometrial polyp Exclusion Criteria: Endometriosis Polycystic ovary syndrome Hydrosalpinx Sub-mucus myoma Women who have taken hormonal therapy in the preceding month

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: HOXA10 and HOXA11 Expression Before Polypectomy<br>A biopsy will taken in infertility patients with endometrial polyp before polypectomy | Procedure: Endometrial biopsy<br> <br> |
| Active Comparator: HOXA10 and HOXA11 Expression After Polypectomy<br>A biopsy will taken in infertility patients with endometrial polyp 1-3 months after polypectomy | Procedure: Endometrial biopsy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of amounts of HOXA10 and HOXA11 expressed before and after polypectomy |  | Four months |
Study of Erythropoietin in Newborns and Children

Study Overview
=================
Brief Summary
-----------------
Erythropoietin (EPO) is a glycoprotein hormone with a molecular weight of 30.4 kDa, responsible for regulating erythropoiesis in adults, newborns and fetuses. During pregnancy, the concentration of maternal serum EPO increases linearly to allow for effective erythropoiesis over time. In the fetus, in the first 30 weeks of gestation, the liver is the main synthetic organ. Thereafter, there is a progressive transfer of the synthesis of EPO to the kidneys. In the long term, under normal conditions of oxygenation, the fetal synthesis of EPO is mainly ensured by the kidney. Because of the impossibility of making EPO tissue reserves and the inability of EPO to pass the placental barrier, the concentration of circulating EPO in the fetus reflects the balance between production and elimination. During the last trimester of pregnancy, in the absence of patent hypoxia, fetal concentrations of circulating EPO are between 10 and 50 mIU /ml, while in amniotic fluid the EPO is found at lower concentrations, between 2 and 20 mIU /ml. In adults, EPO synthesis is primarily renal, and incidentally hepatic, even if in certain pathological situations (end-stage kidney disease or polycystosis) the liver is able to take over and synthesize EPO with an electrophoretic profile similar to that of the EPO from the umbilical cord, but often in insufficient quantities. The objective of this study is to describe the forms of EPO in newborns and to compare possible iso-forms with those of adults.

Official Title
-----------------
Study of Erythropoietin in Newborns and Children

Conditions
-----------------
Newborn Infant, Child Under One Year of Age

Intervention / Treatment
-----------------
* Biological: Plasma collection for EPO assay


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: infant or child under 1 year old hospitalized or consulting at CHU Dijon Bourgogne whose parents have not opposed participation in the study Exclusion Criteria: child treated with recombinant erythropoietin

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 12 Months

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Plasma collection for EPO assay|Plasma collection for EPO assay|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EPO concentration UI/L |  | Baseline | 
| Electrophoretic profile of EPO | It is an indicator of glycosylation differences (more complex forms including sialic acids are more acidic, less complex forms are more basic) | Baseline |
Understanding Male Breast Cancer: Salah Azaïz Cancer Institute Experience

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to evaluate the Salah Azaïz Cancer Institute male breast cancer patients population over a period of 14 years. Goal of the retrospective part: to gather clinicopathologic data and follow-up outcomes of male breast cancer patients diagnosed and/or treated at Salah Azaïz Cancer Institute from 2004 to 2013. Goal of the prospective part: to create a registry of male patients with breast cancer for a period of 48 months (from 2014 to 2017).

Official Title
-----------------
Understanding Male Breast Cancer: Salah Azaïz Cancer Institute Experience

Conditions
-----------------
Male Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histological diagnosis of male breast cancer

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Clinical outcomes | Survival, Disease free survival | Through study completion, an average of 4 year | 
| Clinico-biological characteristics of the disease |  | Through study completion, an average of 4 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast cancer, Male
Efficacy of Imipramine for Treatment of Patients With Esophageal Hypersensitivity/ Functional Heartburn

Study Overview
=================
Brief Summary
-----------------
Esophageal hypersensitivity/Functional heartburn are common among non-erosive reflux disease (NERD) patients who do not response to proton pump inhibitors. Whether tricyclic antidepressant improves NERD patient's symptoms remains unknown Aim of this randomized controlled trial study is to determine the efficacy of imipramine, which could increase esophageal pain thresholds in healthy volunteers, in comparison with placebo for treatment patients with esophageal hypersensitivity or functional heartburn evaluated by improvement of specific-symptom score and quality of life

Official Title
-----------------
Efficacy of Imipramine for Treatment of Patients With Esophageal

Conditions
-----------------
Gastroesophageal Reflux Disease

Intervention / Treatment
-----------------
* Drug: imipramine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient with typical reflux symptoms (heartburn and/or regurgitation) more than 3 times per week in at least last 3 months Age more than 18 years Upper GI endoscopy showed no esophageal mucosal breaks MII-pH monitoring was not showed abnormal both acid and non-acid reflux symptoms was not improved after received standard dose proton pump inhibitor for at least 1 month Exclusion Criteria: history of thoracic, esophagus, or stomach surgery severe esophageal motility disorder eg. Achalasia, scleroderma, autonomic/peripheral neuropathy/myopathy patient who was indicated to receive proton pump inhibitor pregnant women patient who was allergy to imipramine patient who received tricyclic antidepressant or SSRI with in 3 month of enrollment

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: imipramine<br> | Drug: imipramine<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improvement of GERD score |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improve quality of life |  | 6 months |
Stem Cell Therapy in Traumatic Brain Injury

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to study the effect of stem cell therapy on common symptoms in patients with Traumatic Brain Injury

Official Title
-----------------
Open Label Study of Autologous Bone Marrow Mononuclear Cells in Traumatic Brain Injury

Conditions
-----------------
Traumatic Brain Injury

Intervention / Treatment
-----------------
* Biological: Autologous bone marrow mononuclear cell transplantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed cases of chronic traumatic brain injury Age above 6 months Exclusion Criteria: presence of acute infections such as Human immunodeficiency virus/Hepatitis B - Virus/Hepatitis C Virus malignancies bleeding tendencies pneumonia renal failure severe liver dysfunction severe anemia [Hemoglobin < 8] any bone marrow disorder space occupying lesion in brain other acute medical conditions such as respiratory infection and pyrexia pregnancy lactation

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
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: stem cells<br>autologous bone marrow mononuclear cell transplantation | Biological: Autologous bone marrow mononuclear cell transplantation<br>* bone marrow derived mononuclear cells are administered intrathecally in traumatic brain injury patients<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in clinical symptoms of traumatic brain injury |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disability Rating scale |  | 6 months |
Genetics of Symptomatology and Treatment Response in Psychotic Major Depression

Study Overview
=================
Brief Summary
-----------------
We hope to learn more about the biology of psychiatric illness with the hope of improving the diagnosis and treatment of such psychiatric conditions as major depression.

Detailed Description
-----------------
From the blood sample you donate, the researchers will obtain DNA. This DNA will be used to search for DNA markers related to the underlying biology of psychiatric illness and how this might explain the symptoms of these disorders. Research using DNA is an important way to try to understand human disease and/or the role genes play in disease. In effect, part of your blood sample will be used to attempt to understand how genetic factors contribute to the symptoms of such psychiatric conditions as major depression.

Official Title
-----------------
Association of BDNF, COMT, MDRI, CRH, CRF, and GC Receptor Genetic Polymorphisms With Symptomatology and Treatment Response in Psychotic Major Depression

Conditions
-----------------
Psychotic Disorders, Depressive Disorder, Depressive Disorder, Major

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: You are currently experiencing symptoms that are consistent with an episode of major depression without symptoms of psychosis (such as hallucinations, delusions or disorder of thought process), or You are currently experiencing symptoms that are consistent with an episode of major depression with symptoms of psychosis (such as hallucinations, delusions or disorder of thought process), or You have been diagnosed with either schizophrenia or schizoaffective disorder, or You are a volunteer without a history of psychiatric illness (a healthy control subject).
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 |
| --- | --- | --- |
Value of Radiological Follow up in Children Hospitalized With Lobar Pneumonia

Study Overview
=================
Brief Summary
-----------------
The study intends to assess the utility of performing a follow up X rays in children admitted to pediatric wards with lobar pneumonia. Usually those children are discharged with a recommendation for a follow up X rays but there are no enough studies proving that this recommendation is really necessary.

Detailed Description
-----------------
Thew study will include follow up data in a group of about 200 patients admitted with lobar pneumonia during the years 2006 to 2007. All the clinical and laboratory data will be collected and also the X rays findings. The findings of follow up X rays if they were performed will also be summarized.

Official Title
-----------------
The Study Intend to Evaluate the Usefulness of Performing a Follow up X Rays in Children Admitted With Lobar Pneumonia.

Conditions
-----------------
Pneumonia

Intervention / Treatment
-----------------
* Other: Observational


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All pediatric patients discharged with the diagnosis of lobar pneumonia. Exclusion Criteria: Patients with diagnosis of chronic diseases.

Ages Eligible for Study
-----------------
Minimum Age: 3 Months
Maximum 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 |
| --- | --- |
| A<br>Children discharged with the recommendation of performing a follow up X rays after lobar pneumonia | Other: Observational<br>* Retrospective data obtained from electronic files<br>|

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
-----------------
X rays findings
A Study of Albuferon and Ribavirin in Interferon Naive Subjects With Chronic Hepatitis C Genotype 1

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the efficacy and safety of Albuferon in combination with ribavirin in interferon (IFN) alfa treatment-naïve subjects with chronic hepatitis C genotype 1. The study will randomize subjects to 1 of 4 treatment groups including 3 different Albuferon groups or to the active control group, peginterferon alfa-2a (PEGASYS, PEG-IFNalfa-2a). All subjects will also receive oral daily ribavirin.

Official Title
-----------------
A Phase 2b, Randomized, Multi-Center, Active-Controlled, Open-Label Study to Evaluate the Efficacy and Safety of Albuferon (Recombinant Human Albumin-Interferon Alfa Fusion Protein) in Combination With Ribavirin in Interferon Alfa Naive Subjects With Chronic Hepatitis C Genotype 1

Conditions
-----------------
Hepatitis C, Chronic

Intervention / Treatment
-----------------
* Drug: Albuferon
* Drug: Ribavirin
* Drug: PEG-IFNalfa2a


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Interferon treatment naive subjects with chronic hepatitis C, HCV genotype 1. Compensated liver disease Key Exclusion Criteria: Pregnant or lactating female or males with a pregnant partner. A positive test for serum antibodies to the human immunodeficiency virus (HIV-1) or serum hepatitis B virus surface antigen (HBsAg). A history of moderate, severe or uncontrolled psychiatric disease. A history of immunologically mediated disease, seizure disorder, chronic cardiac disease, chronic pulmonary disease, hemoglobinopathy, coagulopathy, or malignancy.

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 |
| --- |
|Drug: Albuferon|nan|
|Drug: Ribavirin|nan|
|Drug: PEG-IFNalfa2a|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained virologic response (SVR), defined as undetectable HCV RNA at 24 weeks after the end of therapy. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Virologic response at Week 4 (VR4), defined as undetectable HCV RNA or a > 2-log reduction in HCV RNA. |  |  | 
| Early virologic response at Week 12 (EVR12), defined as undetectable HCV RNA or a > 2-log reduction in HCV RNA. |  |  | 
| Undetectable HCV RNA at Week 24. |  |  | 
| End of treatment response (ETR), defined as undetectable HCV RNA at Week 48 |  |  | 

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