linjc16/ctgov huggingface dataset:
Viral & Host Factors Associated With Hepatitis B Virus-related Hepatocellular Carcinoma

Study Overview
=================
Brief Summary
-----------------
Adult liver cancer is the third leading cause of cancer deaths worldwide. The major risk factor for liver cancer is hepatitis B virus (HBV) infection. The purpose of the study is to sequence the HBV genome in patients with chronic HBV infection, and in patients with liver cancer resulting from chronic HBV infection. The goal is to identify mutations in the HBV genome that predisposes these high risk individuals to the development of liver cancer.

Official Title
-----------------
Viral and Host Factors Associated With Development of Hepatitis B Virus-related Hepatocellular Carcinoma

Conditions
-----------------
Liver Cancer, Hepatitis B, Hepatitis C, Hepatobiliary Cancers Liver, Hepatobiliary Cancers

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:1. Patients diagnosed with liver cancer based on biopsy or serum AFP level, associated with characteristic hypervascular liver tumors on triphasic spiral CT scan or MRI. 2. Patients with non-cancer liver conditions such as cirrhosis, adenoma, cholangioma, or nodular hyperplasia. 3. Patients with hepatitis B or hepatitis C viral infections not associated with liver cancer. Exclusion Criteria:No other patients except those listed above will be recruited. Additionally, patients will be excluded if, upon looking through their medical records, information required for data analysis are missing.

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 |
| --- | --- | --- |
| identify mutations in the hepatitis B virus genome that predisposes these high risk individuals to the development of liver cancer | We will be using blood specimens collected through another protocol | one time |
Prediction of Low Birth Weight Infants Using Ultrasound Measurement of Placental Diameter and Thickness

Study Overview
=================
Brief Summary
-----------------
Prediction of Low Birth Weight Infants using Ultrasound Measurement of Placental Diameter and Thickness

Detailed Description
-----------------
The aim of the present study is to assess the value of using ultrasound measurement of placental diameter and thickness as a predictor of low birthweight.

Official Title
-----------------
Prediction of Low Birth Weight Infants Using Ultrasound Measurement of Placental Diameter and Thickness

Conditions
-----------------
Intrauterine Growth Restriction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Singleton viable pregnancy. Gestational age at least 36 complete weeks as calculated by LMP. Non scared uterus. Exclusion Criteria: Multiple fetal pregnancy. Intrauterine fetal death. Known congenital fetal anomalies. Presence of uterine or adnexal gross pathology. Presence of any medical disorder e.g. Diabetes mellitus & hypertension.

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 45 Years

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

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 |
| --- | --- | --- |
Postoperative Complications After Cleft Palate Closure in Patients With Pierre Robin Sequence: Operative Considerations

Study Overview
=================
Brief Summary
-----------------
In cleft surgery there is no current general agreement on the treatment strategy of patients with the Pierre Robin Sequence. The timing of surgery and the surgical approach depends on the treating physician or the hospital facility. Literature regarding peri- and postoperative complications in the target population are lacking. The investigators aim to retrospectively review the charts of all cleft patients, both PRS and non-PRS, treated with an adapted Furlow palatoplasty between 01/01/2011 and 31/08/2015. The incidence of peri- and postoperative complications, with a specific focus on respiratory complications, will be examined. The value of demographic, surgical and postoperative parameters will be examined as potential risk factors for the development of complications.

Conditions
-----------------
Pierre Robin Syndrome, Cleft Palate

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients of all ages patients that had undergone a modified Furlow palatoplasty patients treated at the GH Saint-John Bruges (Belgium), or the cooperating Semmelweis University (Hungary) Exclusion Criteria: patients not eligible according to the abovementioned criteria
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pierre Robin Syndrome (PRS)<br>Cleft palate patients with the Pierre Robin Syndrome. | |
| non-PRS<br>Cleft palate patients without the Pierre Robin Syndrome. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of peri- and postoperative complications |  | within 4 weeks postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of potential risk factors (demographic, diagnostic, surgical) for development of postoperative complications, through regression analysis |  | within 4 weeks postoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
peri- and postoperative complications, airway obstruction, adapted Furlow palatoplasty
Clinical Trials to Validate the Use of Additioned Endoscopy in Endoscopic Retrograde Cholangiopancreatography

Study Overview
=================
Brief Summary
-----------------
Validation of clinical use of additioned endoscopy in Endoscopic Retrograde Cholangiopancreatography(ERCP) treatment.

Detailed Description
-----------------
Investigators recently developed a device named additioned Endoscopy. The purpose of current clinical trial is to evaluate the use of additioned endoscopy in ERCP treatment, specifically in shortening the duration of ERCP operation and lowering incidence of complications.

Official Title
-----------------
Validation of Clinical Use of Additioned Endoscopy in Endoscopic Retrograde Cholangiopancreatography

Conditions
-----------------
ERCP

Intervention / Treatment
-----------------
* Device: Additioned Endoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: People who are indicated to ERCP treatment. Exclusion Criteria: People who are not suitable for ERCP treatment.

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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: One arm includes participants who will receive additioned endoscopy assisted ERCP, and the other arm includes participants who will not receive additioned endoscopy assisted ERCP.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ERCP with additioned endoscopy<br>This arm will include participants undergoing ERCP with assistance of additioned endoscopy. | Device: Additioned Endoscopy<br>* To evaluate the use of additioned endoscopy in ERCP treatment.<br>|
| No Intervention: ERCP without additioned endoscopy<br>This arm will include participants undergoing ERCP without assistance of additioned endoscopy as negative controls. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of ERCP treatment | To test if additioned endoscopy will have impact on duration of ERCP treatment | Duration of operation in each patient, ie. from beginning to the end of ERCP operation in each patient | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complications of ERCP treatment | To test if additioned endoscopy will have impact on incidence of ERCP complications, including perforation, bleeding, post-ERCP pancreatitis. | up to 1 month after ERCP completion |
Drug-Eluting Balloon Registry in Routine Clinical Practice

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate long-term effectiveness and safety of patients with coronary disease treated with drug eluting balloon in real world practice.

Official Title
-----------------
Evaluation of Effectiveness and Safety of Drug-Eluting Balloon in Routine Clinical Practice; A Multicenter Prospective Observational Cohort Study

Conditions
-----------------
Coronary Artery Disease, Angioplasty, Balloon

Intervention / Treatment
-----------------
* Device: Balloon angioplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: After pre dilatation residual stenosis 30% and less and also without vessel dissection interrupted blood flow Age 20 and more Treated with Balloon angioplasty Signed informed consent and agreed to follow protocol Exclusion Criteria: Allergy to paclitaxel, antiplatelet History of side effect to heparin, aspirin, thienopyridines History of bleeding tendency, coagulation disorder, blood transfusion reaction

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| Patients with coronary artery disease<br> | Device: Balloon angioplasty<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite Event | Death, Non-fatal myocardial infarction, Target vessel revascularization | 1year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause death |  | 5year | 
| Cardiac death |  | 5year | 
| Myocardial infarction |  | 5year | 
| Composite event | Death or myocardial infarction | 5year | 
| Composite event | Cardiac death or myocardial infarction | 5year | 
| Target vessel revascularization |  | 5year | 
| Target lesion revascularization |  | 5year | 
| Stent thrombosis | Classification of stent thrombosis according to Academic Research Consortium criteria | 5year | 
| Stroke |  | 5year | 
| Procedural Success | Defined as less than 30% residual stenosis at the completion of procedure without death or Q wave myocardial infarction or urgent revascularization. Participants will be followed for the duration of hospital stay, an expected average of 3days. | 3day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Coronary Artery Disease, Angioplasty, Balloon
Identification of the Molecular and/or Pathophysiological Bases of Developmental Diseases

Study Overview
=================
Brief Summary
-----------------
Developmental diseases include more than 3000 diseases and can associate organ malformation, dysmorphism, development disorders and/or intellectual deficiency. Even though the considerable effort in the search for genes in the last 20 years has led to the identification of thousands of genes associated with Mendelian diseases, half of the individuals with severe development anomalies remain without a genetic diagnosis. It is important to pursue the ambition to contribute to the goal fixed by Europe, namely the identification of the large majority of genes responsible for rare diseases with development anomalies, and to be able to provide genetic counselling to patients and their families. In the past, scientific research to discover genes required a large number of families and individuals and was slow and expensive to carry out. Today, this approach has been facilitated by next generation sequencing.

Official Title
-----------------
Identification of the Molecular and/or Pathophysiological Bases of Developmental Diseases

Conditions
-----------------
Developmental Anomalies

Intervention / Treatment
-----------------
* Biological: Blood sample
* Genetic: high-throughput sequencing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients (foetus/children and adults) with development anomalies whose molecular bases are unknown, or for which the pathophysiological mechanism is poorly understood Consent of the patient or his/her legal representative Suitable level of understanding Exclusion Criteria: Patients without national health insurance cover
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Blood sample|for patient and its parents|
|Genetic: high-throughput sequencing|exome or whole genome sequencing|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of new genes identified. |  | through study completion, an average of 5 years |
Effect of C-Peptide on Diabetic Peripheral Neuropathy

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to investigate the effect of C-peptide administration on nerve function in patients with type 1 diabetes and peripheral sensory neuropathy.

Detailed Description
-----------------
It has been observed that C-peptide administration results in an activation of renal tubular and sciatic endoneural Na/K-ATPase of the rat and stimulation of endothelial nitric oxide synthase. The hypothesis is that C-peptide administration may improve peripheral nerve dysfunction in diabetic neuropathy by increasing nerve blood flow and Na/K-ATPase activity. The purpose of the trial is to investigate the effect of C-peptide administration on diabetic peripheral sensory neuropathy in patients with type 1 diabetes and diabetic neuropathy in the lower extremities.

Official Title
-----------------
Effect of C-Peptide on Diabetic Peripheral Neuropathy, a 6 Months Randomized Double-Blind, Placebo Controlled, Dose-Finding, Multicenter Study, With Parallel Groups

Conditions
-----------------
Diabetes Mellitus, Type 1, Diabetic Polyneuropathy

Intervention / Treatment
-----------------
* Drug: C-peptide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who have a duration of type 1 diabetes of more than 5 yrs Subjects who are C-peptide deficient Subjects who have diabetic distal symmetric neuropathy, according to the criteria defined at the San Antonio Conference on Diabetic Neuropathy 1988 Subjects who have measurable action potential in the sural nerves Subjects who have reduced nerve conduction velocity in the sural nerves Exclusion Criteria: Subjects who have neuropathy or signs of nerve dysfunction which may be a consequence of factors other than type 1 diabetes Subjects who have concomitant medication that may interfere with the peripheral nerve function or measurement thereof Subjects who are transplanted (islet cell, kidney or pancreas)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: C-peptide|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in sensory nerve conduction velocity from baseline to 6 mo of treatment |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - Change in quantitative sensory tests and |  |  | 
| neurological impairment assessment from baseline to 6 mo of treatment |  |  | 
| - Safety and tolerability of C-peptide |  |  |
Melatonin Production Delay in Preterm Infants

Study Overview
=================
Brief Summary
-----------------
Objective: Melatonin production is known to be delayed in preterm-born infants up to 6 months of age. This might be related to exposure of preterm infants to continuous lighting in the NICU during a critical period of pineal gland development. The investigators aimed to test the profile of melatonin production in these infants at 9-12 months of age. Methods: Twenty three term-born and 23 preterm-born infants (gestational age: 29-34 weeks) were studied. The investigators tested nocturnal urinary melatonin excretion, within a repeated measures design, both at 9 and 12 months of age. Nocturnal urine was extracted from diapers and urinary melatonin derivate (6-sulphatoxymelatonin) excretion was analyzed by ELISA assay.

Detailed Description
-----------------
Unlike other organs which show catch up in preterm infants after one year of life, the pineal gland shows persistent delay in melatonin production. This field of research has been neglected lately although there are published recommendations for decrease of bright light in NICUs which prevents melatonin development and production, and also recommendations for melatonin treatment in cases respiration recovery in hospitalized preterm infants.

Official Title
-----------------
Term-Born Infants at 9 and 12 Months of Age: A Randomized Controlled Trial

Conditions
-----------------
Melatonin Production

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The investigators included healthy mothers with singleton pregnancies and documented prenatal care who were admitted before term (28-34) weeks gestation to the hospital's delivery room with early uterine contractions and entering stage 1 of an anticipated spontaneous vaginal delivery or term infants born at 38-42 weeks of gestation. Exclusion criteria: Mothers who showed signs of fetal distress during labor, or required Cesarean (C)c-section, or had fetuses withand estimated fetal weights < 10th percentile for gestational age and children diagnosed with Genetic anomalies, congenital heart malformations, gastrointestinal disturbances and central nervous system dysfunction Age < 9 months, Age > 9 months month at onset of study Considered medically unstable

Ages Eligible for Study
-----------------
Minimum Age: 9 Months
Maximum Age: 12 Months

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
6sulphatoxymelatonin, preterm infants, melatonin is low in preterm infants at least until the age of 6 months
Acthar as Rescue Therapy for Transplant Glomerulopathy in Kidney Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to evaluate the benefit of ACTH (Acthar) in reducing proteinuria associated with transplant glomerulopathy in non-diabetic kidney transplant recipients.

Official Title
-----------------
Acthar as Rescue Therapy for Transplant Glomerulopathy in Kidney Transplant Recipients

Conditions
-----------------
Proteinuria, Transplant Glomerulopathy

Intervention / Treatment
-----------------
* Drug: Acthar


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Kidney transplant recipients with confirmed transplant glomerulopathy on kidney biopsy. Failed standard therapy (>25% reduction in proteinuria) including maximum use of an ACE inhibitor, ARB, or aldosterone blocker with a goal blood pressure less than 130/80 and optimization of their immunosuppression Exclusion Criteria: Diabetes

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: Acthar<br>Acthar 80 units twice weekly for 6 months. If endpoint is not reached, duration may be increased to 12 months. | Drug: Acthar<br>* Those interested will be started on Acthar 80 units twice weekly for 6 months. Those with minor adverse effects such as weight gain, worsening hypertension, or glucose intolerance will have their doses reduced to 40 unit twice weekly. Those with major adverse effects such as allergy or infection will discontinue the medication. If the primary endpoint of 50% reduction in proteinuria or total proteinuria less than 150mg/day is not reached, therapy may be continued for a total of 12 months.<br>* Other names: Adrenocorticotropic Hormone;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 50% Reduction in Proteinuria or Proteinuria < 150mg/Day |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 25% Improvement in the MDRD eGFR |  | 6 months |