linjc16/ctgov huggingface dataset:
A Multidrug-resistant (MDR) and Extensively Drug- Resistant (XDR) Tuberculosis Study in Alsace

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the epidemiology of TB MR in Strasbourg and evaluate the second-line anti-tuberculosis treatments effectiveness, and the relevance and adequacy of the treatments with WHO recommendations. During years 2006-2016, all new cases of MDR TB or XDR TB diagnosed Strasbourg University Hospital will be included in the study (22 cases). Data were collected from the Center for Tuberculosis Control (CLAT) records, the patient's medical records.

Official Title
-----------------
Epidemiology and Treatment of Multidrug-resistant (MDR TB) and Extensively Drug- Resistant (XDR TB) Tuberculosis in Strasbourg, France; a 10 Years Retrospective Study

Conditions
-----------------
Tuberculosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Major patient (≥18 years old) Patient hospitalized at Strasbourg University Hospital from 2006 to 2016, with proven MDR or XDR tuberculosis Exclusion Criteria: - Refusal of the patient to participate in the study

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 |
| --- | --- | --- |
| Study of clinical characteristics of patients hospitalized at Strasbourg University Hospital from 2006 to 2016, with proven MDR or XDR tuberculosis |  | The period from January 1st, 2006 to December 31st, 2016 will be examined | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Migrant, Tuberculosis, Multi-drug Resistant Tuberculosis, Observational retrospective study, Clinical epidemiology, Treatment outcome, Precarity
Pegteograstim in Children With Solid Tumors

Study Overview
=================
Brief Summary
-----------------
To evaluate the efficacy and safety of pegteograstim on chemotherapy-induced neutropenia in children with solid tumors

Detailed Description
-----------------
Children with solid tumor experience neutropenia after cytotoxic chemotherapy, and they usually receive granulocyte colony-stimulating factor (G-CSF) to stimulate neutrophil recovery. However it needs daily injection of G-CSF. Pegteograstim is a new formulation of PEGylated recombinant human G-CSF analogue pegfilgrastim. In this study, investigators aimed to evaluate the efficacy and safety of pegteograstim on chemotherapy-induced neutropenia in children with solid tumors.

Official Title
-----------------
Efficacy and Safety of Pegteograstim on Chemotherapy-induced Neutropenia in Children With Solid Tumors

Conditions
-----------------
Chemotherapy Induced Neutropenia, Pediatric Solid Tumor

Intervention / Treatment
-----------------
* Drug: Pegteograstim


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with solid tumor who undergo chemotherapy with carboplatin, etoposide, doxorubicin, cyclophosphamide (CEDC) and ifosfamide, carboplatin, etoposide (ICE) regimen Exclusion Criteria: Patients with organ dysfunction (creatinine > 2mg/dL, ejection fraction <40% or severe arrhythmia/conduction disorder, other severe organ dysfunction) Hypersensitivity to pegteograstim, protein originated from E-coli, pegfilgrastim, filgrastim or latex. Patients with bleeding tendency to whom subcutaneous injection should be avoided. Active infection or infectious fever during the screening period. Genetic problem to fructose tolerance. Patients who participated in other clinical trial within 4 weeks before enrollment. Pregnant and nursing women

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chemotherapy induced neutropenia<br>Pegteograstim 100 ug/kg (maximum 6 mg) on day 7 of the chemotherapy cycle | Drug: Pegteograstim<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of adverse events |  | Up to 3 weeks after the injection of pegteograsim | 
| Duration of neutropenia (absolute neutrophil count (ANC) < 500/uL) |  | Up to 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of severe neutropenia (ANC < 100/uL) |  | Up to 6 weeks | 
| Lowest value of ANC |  | Up to 6 weeks | 
| Days with neutropenic fever |  | Up to 6 weeks |
Pigment-Tan-Safety Study of a Light-based Home Device for Hair Removal in Adult Subjects

Study Overview
=================
Brief Summary
-----------------
This studies was designed to investigate the importance of skin type and UV-exposure on side effects after exposure to an Intense Pulsed Light Home-use device. 21 healthy subjects will receive 8 UV-exposures on one buttock and subsequently three weekly IPL-exposures.

Detailed Description
-----------------
Twenty-one healthy subjects will be exposed to UV-exposures 8 times over 3 weeks on a test-area (4 x 6cm) on one buttock to induce pigmentation. This will be followed by 3 weekly IPL (intense pulsed light) exposures. At 24 hours after the first IPL exposure, biopsies will be excised from the buttocks of the subjects (4 each).The skin will be evaluated after IPL exposure for: skin reactions, pain and mRNA expression of two pigment markers. Follow-up visits is planned at 1 and 4 weeks after the third and final IPL exposure.

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Device: IPL-home use device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy, over 18 years, no childbearing potential, signed informed consent, no moles,tattoos, freckles or scars in the test-area, skin type II-IV Exclusion Criteria: disease in test-area, prior treatment to IPL, taking drugs interfering with the immune system

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

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

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

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

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IPL after UV-exposure<br>8 UV-exposures followed by 3 weekly IPL exposures | Device: IPL-home use device<br>* A light based home use device for hair removal<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in skin reaction development | Redness, edema, pigment changes, texture changes, blisters and crusting | Immediately after, 1 hr after, 16-24 hrs after, 1 week and 4 weeks after IPL exposure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain |  | Immediately after IPL exposure (approx. 2 min) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pigment,, Intense pulsed light,, UV-exposure,, skin type,, safety,, home-use, subjects
Study to Image the Esophagus Using the OFDI Capsule

Study Overview
=================
Brief Summary
-----------------
The main purpose of this research is to test the feasibility and tolerability of the tethered capsule Optical Frequency Domain Imaging (OFDI)

Detailed Description
-----------------
A total of 56 subjects with Barrett's Esophagus, EoE and healthy volunteers will be asked to swallow the OFDI capsule while being unsedated. The capsule is attached to a tether that allows the capsule operator to navigate the capsule as it progresses down the esophagus using natural propulsion called peristalsis as well as to bring it back up to pulled out of the mouth when the procedure is done. As the capsule progresses down the esophagus, multiple, two dimensional, microscopic cross- sectional images of the esophagus are acquired.

Official Title
-----------------
Pilot Study for Imaging of the Esophagus Using an OFDI Capsule

Conditions
-----------------
Barrett's Esophagus, Eosinophilic Esophagitis

Intervention / Treatment
-----------------
* Device: OFDI Capsule


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A previous diagnosis of Barrett's Esophagus OR a previous diagnosis of EoE OR a previous diagnosis of Gastroesophageal reflux disease (GERD) Subject must be 18 years or older in case of Barrett's and GERD, and over the age of 16 years for EoE Subject must be able to give informed consent Exclusion Criteria: Subjects with known esophageal strictures, intestinal strictures or dysphagia OR subjects with a history of prior GI surgery or GI Intestinal Crohn's disease

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OFDI Capsule Imaging<br>Subject will swallow the OFDI capsule and imaging will be acquired using the OFDI Imaging system. | Device: OFDI Capsule<br>* Imaging of the esophagus using the OFDI Capsule and system<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of OFDI Imaging in Subjects Swallowing the OFDI Capsule | Number of subjects from whom the quality OFDI imaging was obtained | Images will be acquired during the OFDI imaging session which should take an average of 5 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Optical Coherence Tomography, Barrett's Esophagus, Esophagus, Imaging
Observational Study of Pergolide Mesylate and Cardiac Valvulopathy

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to estimate the incidence of new-onset valvulopathy, determined by baseline and follow-up echocardiograms, in patients with Parkinson's Disease who are receiving pergolide as second-line therapy. The secondary objective of the study is to estimate the prevalence of valvulopathy, as determined by baseline echocardiograms, among all patients who have Parkinson's Disease and are being considered for pergolide as second-line therapy.

Official Title
-----------------
Observational Study to Determine the Incidence of New-Onset Valvulopathy in Patients Treated With Pergolide as Second-Line Therapy for Parkinson's Disease

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female, age 18 and older with a diagnosis of Parkinson's Disease Receiving pergolide as second-line therapy as prescribed by Summary of Product Characteristics Willing to participate and sign a consent to release medical information Have had an echocardiogram within 3 months of initiation of pergolide therapy with no evidence of cardiac valvulopathy Exclusion Criteria: There are no exclusion criteria for this 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?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Visual Outcomes Following Descemet Stripping Automated Endothelial Keratoplasty

Study Overview
=================
Brief Summary
-----------------
To assess objective and subjective visual outcomes achieved by patients with corneal endothelial dysfunction who have undergone surgical treatment with Descemet stripping automated endothelial keratoplasty (DSAEK).

Detailed Description
-----------------
Since 2006, the technique by removing the Descemet membrane from the recipient cornea was renamed Descemet stripping automated endothelial keratoplasty (DSAEK). In recent years, DSAEK techniques have evolved, favoring increasingly thinner and finer grafts, known as ultrathin DSAEK (UT DSAEK), with the aim of obtaining better visual results. Endothelial keratoplasty is now the most common surgical procedure used to treat endothelial dysfunction. The current study focused on assessing both objective and subjective visual quality outcomes following DSAEK.

Official Title
-----------------
Visual Outcomes Following Descemet Stripping Automated Endothelial Keratoplasty for Corneal Endothelial Dysfunction

Conditions
-----------------
Corneal Endothelial Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical eligibility for DSAEK Informed written consent Successful completion of DSAEK procedure Postoperative follow-up at least 1 year Ability to respond to the questionnaire Exclusion Criteria: Patients with clinical edematous cornea With significant stromal opacity With major disturbances of ocular surface Previous corneal surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Visual acuity | Scored with reference to the logarithm of the minimum angle of resolution (logMAR) and its variation in line gain. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
DSAEK
Dislocated Unstable Distal Both-Bone Forearm Fractures in Children

Study Overview
=================
Brief Summary
-----------------
We create a follow-up study of Kirschner wire fixation of a unstable dislocated distal both-bone forearm fracture.

Detailed Description
-----------------
children who arrive at the emergency unit with a dislocated both-bone distal forearm fracture will be asked to join the trial. After an unstable reposition, the fracture will be fixated with 2 Kirschner-wires. The arm will be immobilised in above elbow cast during 4 weeks. Outpatient clinic visits till a follow-up of 6 months. During these visits we will investigate: consolidation and dislocation on X-ray, function of both arms, complains in daily living and complications.

Official Title
-----------------
Treatment of Unstable Dislocated Both-Bone Distal Forearm Fractures in Children: A Follow-up Study

Conditions
-----------------
Fracture, Forearm, Distal, Child, Treatment

Intervention / Treatment
-----------------
* Procedure: Kirschner-wire fixation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: both-bone forearm fracture distal dislocated unstable after reposition age < 16 years Exclusion Criteria: fracture older than 1 week no informed consent refracture open fracture (Gustillo 2 and 3) both fractures of type torus

Ages Eligible for Study
-----------------
Maximum Age: 15 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Kirschner-wire fixation|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pronation and supination |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complications, function, esthetics, complains in daily living, X-rays |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fracture, Forearm, Distal, Child, Treatment
AiM COVID for Covid 19 Tracking and Prediction

Study Overview
=================
Brief Summary
-----------------
University of Warwick (Coventry, UK) and NTUU Igor Sikorsky Kyiv Polytechnic Institute (Kyiv, Ukraine), together with ClickMedix LLC, have developed an app and a chatbot AiM COVID for efficient monitoring and mitigation of COVID-19. These products are available for free download on computers and mobile phones. These can be used by a wide range of users from various sectors - patients and people living with them, doctors, nurses, specialists, community health workers, hospitals, clinics, hospital IT staff, MHFA, and insurance companies.

Official Title
-----------------
AiM COVID for Covid 19 Tracking and Prediction

Conditions
-----------------
COVID 19

Intervention / Treatment
-----------------
* Other: No Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants 18 and above living in UK reported with or without symptoms from February 28 to March 28 with community support groups Exclusion Criteria: below 18 years old

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: No Intervention|No intervention|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical symptoms | Self reported physical symptoms | 1day | 
| Contact History | Contact with suspected, confirmed or ill person | 14 days | 
| Travel History | Travel to or from overseas | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fever | Self reported body temperature | 1 day | 
| Headache | Self reported headache using yes/no | 1 day | 
| Soar Throat | Self reported soar throat using yes/no | 1 day | 
| Runny nose | Self reported runny nose using yes/no | 1 day | 
| Cough | Self reported cough using yes/no | 1 day | 
| Shortness of breath | Self reported shortness of breath symptoms using yes/no | 1 day | 
| Nausea | Self reported nausea using yes/no | 1 day | 
| Vomiting | Self reported vomiting using yes/no | 1 day | 
| Muscle pain | Self reported muscle pain using yes/no | 1 day | 
| Joint pain | Self reported joint pain using yes/no | 1 day | 
| Diarrhoea | Self reported Diarrhoea using yes/no | 1 day | 
| Other | Self reported other symptoms using yes/no | 1 day | 
| Hospitalisation history | Self reported hospitalisation using yes/no | 1 day | 
| Co-morbid conditions | Self reported co-morbid conditions using checked box | 1 day |
Prospective Evaluation of the Use of Thunderbeat Vessel Sealing Device in Laparoscopic Surgery

Study Overview
=================
Brief Summary
-----------------
All patients undergoing laparoscopic visceral and gynecologic procedures using the combined bipolar and ultrasonic vessel sealing and dissection device Thunderbeat are entered in a prospective registry. Data will be analysed concerning the safe use of the instrument and perioperative blood loss.

Conditions
-----------------
Indication for Laparoscopic Surgery (Any)

Intervention / Treatment
-----------------
* Device: Use of Thunderbeat (TM) in laparoscopic surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients undergoing laparoscopic visceral or gynecologic surgery need for a vessel sealing device during surgery Exclusion Criteria: non able to understand informed consent or missing consent age <18

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 |
| --- | --- |
| Patients undergoing laparoscopic surgery<br> | Device: Use of Thunderbeat (TM) in laparoscopic surgery<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intra- and postoperative device-related complications |  | 30 days | 
| Use of additional vessel sealing devices |  | one day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perioperative Blood Loss |  | 30 days | 
| Duration of Surgery |  | one day |
Inflammation as a Predictor in Cardioversion of Atrial Fibrillation

Study Overview
=================
Brief Summary
-----------------
The laboratory test, C-Reactive Protein (CRP), has become well established as a marker of inflammation. Recently a high CRP level (indicating an increase in inflammation) was identified as a risk factor for atrial fibrillation. We are conducting this study with patients such as yourself with atrial fibrillation who are planning to undergo cardioversion to determine what sort of relationship exists between CRP levels and atrial fibrillation. We will then look at success rates of converting atrial fibrillation to normal sinus rhythm, compared to patients' CRP levels.

Official Title
-----------------
Inflammation as a Predictor in Cardioversion of Atrial Fibrillation

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

Intervention / Treatment
-----------------
* Procedure: Cardioversion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Atrial fibrillation patients referred for DC cardioversion On stable medical therapy Exclusion Criteria Known chronic inflammatory states such as infections, rheumatoid arthritis or known vasculitides. Patients having undergone recent surgery or who are on steroid therapy for any reason will be excluded.

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- |
| 1<br> | Procedure: Cardioversion<br>* Baseline hsCRP will be drawn the morning of, prior to, cardioversion. An EKG to document the patient's rhythm will be obtained at the one-month mark<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| We hypothesize that a higher hsCRP is associated with higher failure rates in patients undergoing cardioversion for atrial fibrillation |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| secondary endpoint will be if a new inflammatory disease state is diagnosed at the one-month mark. |  | 1 month | 

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