linjc16/ctgov huggingface dataset:
The Hepatitis Delta International Network

Study Overview
=================
Brief Summary
-----------------
Hepatitis delta is a major health problem, not only because of the severity of the disease, but also due to the lack of effective antiviral treatment. To improve the current therapeutic options, a better understanding of the pathophysiology is essential. Reliable research in this direction is only possible with large patient study groups. However, given the geographic distribution of hepatitis delta, larger patient cohorts would only be possible through multicenter collaboration.

Detailed Description
-----------------
The hepatitis international network cohort is a multicenter, observational study that will build up a research registry of HDV patients all over the world. The aims of this project are: i. Collect clinical information from hepatitis delta patients from multiple centers distributed worldwide in order to build up a large database that will enable and facilitate further research on chronic hepatitis delta. ii. To better inform patients about their viral infection, present status and evolution of liver disease throughout time. To give them the tools needed to inform other peers and medical professionals about the significance and consequences of a chronic hepatitis delta infection. iii. To allow the participating physicians to track course of the disease, therapies, signs and symptoms of the hepatitis delta patients included by their center.

Official Title
-----------------
Hepatitis Delta Registry and Research Network- Observational Study

Conditions
-----------------
Hepatitis D

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Positive HBs antigen and antiHDV for longer than 6 months. Exclusion Criteria: Absence of any cause of relevant liver disease other than HDV (i.e. hemochromatosis, autoimmune hepatitis, alcoholic or toxic liver disease, etc.)
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 |
| --- | --- | --- |
| Proportion of chronic hepatitis B patients with chronic hepatitis D infection worldwide |  | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HDV-RNA HBsAg |  | 10 years | 
| HBV-DNA |  | 10 years | 
| Proportion of treated chronic hepatitis B patients with chronic hepatitis D infection worldwide |  | 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HDV, hepatitis delta
Multiple Areas of Pain (MAP)

Study Overview
=================
Brief Summary
-----------------
This study will collect pain-related information from chronic pain patients to gain an understanding of the prevalence of multi-site pain, and how it affects health outcomes like function, quality of life, depression, and anxiety.

Official Title
-----------------
Multiple Areas of Pain (MAP): Epidemiology of Multisite Pain in the Chronic Pain Population

Conditions
-----------------
Chronic Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Chronic pain of the trunk and/or limbs lasting at least 6 months Overall pain intensity of at least 5 on a 0 to 10 scale Subject is able to independently complete all assessments in English 18 years of age or older Subject signs an Institutional Review Board-approved informed consent form provided in English Key Exclusion Criteria: Currently implanted with an active implantable medical device to treat pain Currently exhibits any characteristic that renders the subject ineligible for current or future treatment with spinal cord stimulation for chronic pain of the trunk and/or limbs Subject has undergone an interventional pain procedure less than 1 month prior to the study

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 |
| --- | --- |
| Chronic pain patients<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Multi-site Pain Index | Multiple Site Pain Index (MSPI) was developed by collating multiple pain descriptors into a single index. Pain descriptors used for developing this index were percent body area in pain, number of painful areas, span of painful areas, and Regional Pain Ratings (RPRs) which includes data on pain severity and pain continuity for 47 body regions. MSPI score ranged from 0 to 1; 0 representing no pain and 1 representing extreme continuous pain over entire body, except the head and face regions. | single-visit |
HLA Sensitization Following Major Cortical Allograft Bone Procedures

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to find out whether or not antibodies to the donor bone are present in the blood of patients who receive the donor bone.

Detailed Description
-----------------
Patients who have bone cancer often have the cancerous bone removed by surgery and replaced with a piece of bone taken from a donor (a person who donates parts of their body to be used for transplants after their death). However, sometimes this replacement bone does not heal together with the patient's bone. The reason the bone does not heal is not known but it is thought that the patient's body may react to the donor bone by producing antibodies against cells on the donor bone. The purpose of this study is to find out whether or not antibodies to the donor bone are present in the blood of patients who receive the donor bone. You have been asked to participate in this study because you are scheduled to undergo this type of surgery.

Official Title
-----------------
HLA Sensitization Following Major Cortical Allograft Bone Procedures

Conditions
-----------------
Bone Cancer

Intervention / Treatment
-----------------
* Procedure: retrieve blood samples


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients twelve years or older who are scheduled for massive fresh-frozen human structural bone allograft implantation at participating centers will be given the opportunity to participate in the study. All patients must have a reconstruction of the involved long bone with either an intercalary graft, an osteoarticular graft, or an allograft/endoprosthesis composite graft. The junction or union site studied will be the cortical-cortical, host allograft junction site, not the cancellous interfaces. Exclusion Criteria: Patients who do not require major weight bearing cortical allograft bone grafts will be excluded. Also, women who are or could potentially become pregnant will be excluded from the study.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: retrieve blood samples|blood samples obtain pre-op, 6 and 12 months post-op|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Leipzig FAST-TRACK Over 15 Years for Cardiac Surgical Patients

Study Overview
=================
Brief Summary
-----------------
Since November 2005, we are running a specialized post anesthetic care unit (PACU) in our tertiary, university affiliated high-volume heart centre. In our concept, we are bypassing ICU admission completely. The fast-track concept was initially applied to pre-selected elective patients undergoing low-risk operations. However, promising outcomes led to a more widespread utilization with more complex procedures. The aim of this study is to analyse the fast track evolutions.

Detailed Description
-----------------
Fast Track Treatment includes many elements recommended by the ERAS Society for cardiac surgery(1). Since November 2005, we are running a specialized post anesthetic care unit (PACU) in our tertiary, university affiliated high-volume heart centre. In our concept, we are bypassing ICU admission completely. The patients are transferred from the operation room to the recovery room, extubated there within a short time, stabilized and transferred on the same day to intermediate care (IMC). Ideally, the patient will be transferred to the normal ward on the first postoperative day. The fast-track concept was initially applied to pre-selected elective patients undergoing low-risk operations. However, promising outcomes led to a more widespread utilization with more complex procedures. The aim of this study is to analyse the evolutions within the fast-track protocol over a period of 15 years (from November 2005 to December 2020).

Official Title
-----------------
Retrospective Analysis of 15 Years of Leipzig Fast-Track Concept.

Conditions
-----------------
Post-cardiac Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults >18y Exclusion Criteria: Incomplete data Catheter-valve implantation

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FT evolution analysis in complexity | Trends analysis in complexity ( using EUROSCORE II) against time (in years) | Novmber 2005- December 2020 | 
| FT evolution analysis in length of stay | Trends analysis of length of stay ( in hospital and ICU in days) against time (in years) | Novmber 2005- December 2020 | 
| FT evolution analysis in postoperative complications | Trends analysis in postoperative complications ( cardiac, pulmonary, and neurological) in percentage against time ( in years) | Novmber 2005- December 2020 | 
| FT evolution analysis in postoperative mortality rate | Trends analysis of postoperative mortality rate ( in percentage) against time (in years) | Novmber 2005- December 2020 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fast track after cardiac surgery, ERAS cardiac surgery
Chinese PD-GBA Registry

Study Overview
=================
Brief Summary
-----------------
The purpose of the Chinese Parkinson's disease with GBA variants Registry (CPD-GBAR) is to develop a database of patients of Parkinson's disease with Glucocerebrosidase (GBA) gene variants in mainland China.

Detailed Description
-----------------
Parkinson's disease (PD) is the second most common disorder among neurodegenerative diseases. GBA gene variants such as L444P can influence the risk of developing PD and these variants have the greatest impact on PD susceptibility among all the PD related gene variants yet discovered. The investigators aim to establish a database of PD with GBA variants and characterize the clinical manifestation of these patients in mainland China. Method: Peripheral blood from patients has been tested to have GBA gene variants. Clinical manifestation will be measured by scales and neurological tests. Standard scales include: Unified Parkinson's Disease Rating Scale(UPDRS), Hoehn-Yahr stages, Non-Motor Symptoms Scale (NMSS), mini-mental state examination (MMSE), Parkinson disease sleep scales (PDSS), Rapid Eye Movement Sleep Behaviour Disorder Questionnaire(RBDQ-HK), Epworth Sleepiness Scale (ESS), Rome III functional constipation scale, the Scale for Outcomes in PD for Autonomic Symptoms (SCOPA-AUT), Parkinson Fatigue Scale (PFS), Cambridge-Hopkins Restless Legs Syndrome questionnaire (CHRLSq), Hyposmia rating scale(HRS), Hamilton depression scale, the 39-item Parkinson's Disease Questionnaire(PDQ-39), Freezing of gait scale(FOG), dyskinesia related scales, Wearing-off scale(WO). The investigators will also exam the blood biomarkers of PD such as uric acid and peripheral inflammatory markers.

Official Title
-----------------
The Chinese Parkinson's Disease With GBA Variants Registry

Conditions
-----------------
Parkinson Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with PD by the United Kingdom Parkinson's Disease Society Brain Bank clinical diagnostic criteria or other standard criteria; PD patients detected with GBA gene variants. Exclusion Criteria: -
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 |
| --- | --- | --- |
| Database of Parkinson's disease with GBA variants | Establish the database of Parkinson's disease with GBA variants in mainland China. | 10 years | 
| Clinical feature | Characterize the clinical feature of PD patients with GBA variants | 10 years |
Adequacy and Efficacy of the e2TM Cervical Cell Collector Compared to Standard Spatula/CytoBrush Technique.

Study Overview
=================
Brief Summary
-----------------
A clinical study to determine the adequacy and efficacy of the InPath e2TM Collector compared to the FDA-approved spatula/cytobrush when used as the cell collection device in screening for cervical cancer. The InPath e2TM Collector name has been changed to the CytoCore SoftPAP(R) Collector

Detailed Description
-----------------
The e2TM (SoftPAP) Collector collects only cells that have been exfoliated from the cervix whereas spatulas, brushes and broom-style collection devices collect cells by scraping or abrading the cervix. THis trial is to determine whether the purely exfoliated sample collected using the e2TM Collector is equivalent to samples obtained by scraping or abrading the cervix for purposes of cervical cancer screening and HPV detection.

Official Title
-----------------
Clinical Study Validating the Adequacy, Efficacy, and Safety of the e2TM Cervical Cell Collector Compared to Standard Spatula/CytoBrush Technique In Patients With Recent History of Abnormal Pap Test Returning for Colposcopy/Biopsy.

Conditions
-----------------
Colposcopy, Biopsy

Intervention / Treatment
-----------------
* Device: e2 Cell Collector [SoftPAP(R)]
* Device: Spatula/Brush


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women ages 18 years old and above Women scheduled to undergo colposcopy Exclusion Criteria: Patients who have had a hysterectomy Patients who are pregnant.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Arm 1 - Experimental<br>e2 Cell Collector [SoftPAP(R)] | Device: e2 Cell Collector [SoftPAP(R)]<br>* Cervical cells collected using the e2 Cell Collector [SoftPAP(R)]<br>|
| Arm 2 - Control<br>Brush/spatula | Device: Spatula/Brush<br>* Cervical cells collected using a combination of a cervical spatula and an endocervical brush<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cell Collection Efficacy | True Positive (TP); True Negative (TN), False Positive (FP) and False Negative (FN) participants and percentage of participants based upon comparison of the cytology diagnosis (Dx) with biopsy (Bx) and endocervical curretage (ECC) results from the same patient. | At the time of cell collection. | 
| Specimen Adequacy | Number and percentage of samples classified as adequate for diagnosis | At time of cell collection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Human Papilloma Virus (HPV) Detection Frequency | Number and percentage of HPV positive specimens by the Hybrid Capture II (HC-II) assay | At the time of cell collection. |
A Comparative Study Between Two Formulations of the Ciprofloxacin Hydrochloride + Hydrocortisone Otic Suspension

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to compare the efficacy and safety profiles of the test product containing 2 mg/mL ciprofloxacin hydrochloride associated with 10 mg/mL of hydrocortisone with the reference product Cipro HC®, in patients with acute otitis externa.

Detailed Description
-----------------
Phase III, non inferiority, multicentric, controlled, single blind, parallel-group, randomized study. Population: 224 patients with external otitis , men and women aged between 1 - 70 years. Primary endpoint: The primary endpoint of this study is the elimination of pain, swelling and otorrhea (cure). Secondary endpoint: The endpoint will be the identification of the side effects of medication use.

Official Title
-----------------
Multicentric, Double Blind, Randomized, Parallel Comparative Study Between Ciprofloxacin HCl 2 mg/mL + Hydrocortisone 10 mg/mL Ear Suspension and Cipro HC®, for the Assessment of Efficacy and Safety in Patients With Otitis Externa.

Conditions
-----------------
Otitis Externa

Intervention / Treatment
-----------------
* Drug: Cipro HC
* Drug: Ciprofloxacin HCl and Hydrocortisone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed of the nature of the study and given written informed consent; Patients with acute otitis externa; Intact tympanic membrane. Exclusion Criteria: Known allergy or sensitivity to Ciprofloxacin Hydrochloride and Hydrocortisone; Patient has the tympanic membrane not intact; Diabetes Bilateral Acute Otitis Externa; Pregnant or lactating patients; Overt fungal Acute Otitis Externa; Other diseases of the ear Current Infection requiring systemic antimicrobial therapy. Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study.

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cipro HC<br>Reference product | Drug: Cipro HC<br>* Cipro HC (Ciprofloxacin HCl and Hydrocortisone)<br>|
| Experimental: Ciprofloxacin HCl and Hydrocortisone<br>Test product | Drug: Ciprofloxacin HCl and Hydrocortisone<br>* Ciprofloxacin Hydrochloride and Hydrocortisone<br>* Other names: Otociriax;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cure (reduced pain, swelling and otorrhea) |  | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of possible side effects |  | 7 days |
Evaluation of Metformin Activity in Addition to Conventional Treatment of Grade II or III Pulmonary Arterial Hypertension (PAH)

Study Overview
=================
Brief Summary
-----------------
Treatment of PAH includes exercise limitation, non specific agents (anticoagulants, diuretics and supplemental oxygen), pulmonary specific vasodilators and antiproliferative agents. Recent data obtained by our group, within rat PAH models, showed that the antihyperglycemic drug metformin, used in France since 1959 in diabetic type II patients, significantly acts at the pulmonary arteries level. According to these results, and knowing that metformin is a widely used drug, with a favorable safety profile, the investigators decided to set up a pilot study, in order to evaluate the activity of metformin in PAH treatment. In parallel, the investigators will focus on metformin mechanism of action.

Conditions
-----------------
Pulmonary Arterial Hypertension

Intervention / Treatment
-----------------
* Drug: Metformin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men or women aged between 18 and 80 Patients included will have pre-capillary PAH they have to be stable for more than 3 months Patient with a 6-minute walk test comparable over the last 3 months before inclusion Informed consent signed

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Metformin<br> | Drug: Metformin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective of this study will be to demonstrate the improvement of walk test distance in patients with pulmonary arterial hypertension (PAH) treated by metformin. |  |  |
FFA Metabolism in Different Types of Human Obesity

Study Overview
=================
Brief Summary
-----------------
We will give intravenous fat molecules to help us understand how the fat that is released from peoples fat cells is used. This will be done when people are eating, not eating and walking.

Official Title
-----------------
FFA Metabolism in Different Types of Human Obesity

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI 28-36 -upper body obesity and lower body obesity non-obese BMI 19-24. Females premenopausal. Must be a non-smoker. Exclusion Criteria: BP> 160/95 on HTN meds, known systemic illness. Medications that affect fat metabolism. We do no cover travel expenses. Known heart and vascular disease.

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