linjc16/ctgov huggingface dataset:
Treatment Use of 3,4-Diaminopyridine

Study Overview
=================
Brief Summary
-----------------
This protocol has provided 3,4 diaminopyridine (DAP) under a treatment-use IND to patients with congenital myasthenic syndrome (CMS). It is currently closed to enrollment.

Detailed Description
-----------------
CMS diagnoses are made based on clinical, electromyographic and molecular genetic findings, and all patients have been referred to the PI for DAP treatment. This study enrolled minors and adults. CMS patients under age 18 years were included if their parent or guardian gave written permission. Minors who turn 18 while in the program will be re-consented as adults. The dose of DAP is determined individually for each patient. Adults are started with a dose of 10 mg 3-4 times daily, increased over several weeks to the dose that produces the maximum symptomatic response, not to exceed 100 mg daily. Pyridostigmine bromide (PB) may be added at low doses and increased to the dose that produced the best response, not to exceed 360 mg daily. In children, equivalent doses of these medications is calculated on a surface area basis. The doses of DAP and PB are periodically adjusted to assure that the smallest effective doses are used. Patients who achieve significant clinical benefit from DAP, as judged by the study PI and the patient, may continue taking DAP as long as the drug is available from the sponsor, and as long as they return for regular follow-up evaluations at the Duke MG Clinic. Patients who are unable to return for regular follow-up will be required to have their local physician obtain DAP for them from the sponsor.

Official Title
-----------------
Treatment Use of 3,4-Diaminopyridine in Congenital Myasthenic Syndrome

Conditions
-----------------
Myasthenic Syndromes, Congenital

Intervention / Treatment
-----------------
* Drug: 3,4-diaminopyridine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of congenital myasthenic syndrome (CMS) Women of childbearing potential must have negative pregnancy test and agree to practice adequate contraception while taking DAP Must be competent to give consent Exclusion Criteria: Known seizure disorder Pregnancy Known cardiac arrhythmia or evidence of significant arrhythmia on screening ECG Known hepatic, renal or hematologic disease
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: 3,4-diaminopyridine|Treatment use of 3,4-DAP for patients with congenital myasthenic syndrome (CMS)|

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
-----------------
3,4 diaminopyridine (DAP)
A Study to Assess Etoricoxib Versus Diclofenac in Chinese Patients With Osteoarthritis of the Knee or Hip (0663-080)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
A Study to Assess Etoricoxib versus Diclofenac in Chinese Patients with Osteoarthritis of the Knee or Hip

Official Title
-----------------
A Multicenter, Randomized, Parallel-group, 4-Week, Double-Blind and Active Comparator-Controlled Study to Assess Efficacy, Safety, and Tolerability of Etoricoxib 60 mg Once Daily Versus Diclofenac Sodium 75 mg Twice Daily in the Treatment of Chinese Patients With Osteoarthritis of the Knee or Hip

Conditions
-----------------
Osteoarthritis

Intervention / Treatment
-----------------
* Drug: MK0663; etoricoxib / Duration of Treatment:4 Weeks
* Drug: Comparator: diclofenac sodium tablet 75 mg / Duration of Treatment:4 Weeks


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chinese males or females at least 40 years of age with osteoarthritis of the knee or hip

Ages Eligible for Study
-----------------
Minimum Age: 40 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: MK0663; etoricoxib / Duration of Treatment:4 Weeks|nan|
|Drug: Comparator: diclofenac sodium tablet 75 mg / Duration of Treatment:4 Weeks|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WOMAC pain subscale |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WOMAC Physical function subscale; WOMAC Stiffness subscale; Patient Global Assessment of Response to Therapy; Investigator Global Assessment of Disease Status |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Arcoxia
Automatic Diagnosis of Spinal Stenosis on CT

Study Overview
=================
Brief Summary
-----------------
MRI is a common tool for radiographic diagnosis of spinal stenosis, but it is expensive and requires long scanning time. CT is also a useful tool to diagnose spinal stenosis, yet interpretation can be time-consuming with high inter-reader variability even among the most specialized radiologists. In this study, the investigators aim to develop a deep-learning algorithm to automatically detect and classify lumbar spinal stenosis.

Detailed Description
-----------------
MRI is a common tool for radiographic diagnosis of spinal stenosis, but it is expensive and requires long scanning time. CT is also a useful tool to diagnose spinal stenosis, yet interpretation can be time-consuming with high inter-reader variability even among the most specialized radiologists. In this study, the investigators aim to develop a deep-learning algorithm to automatically detect and classify lumbar spinal stenosis. It would be a time-saving workflow if the software can assist the radiologists to detect and locate the suspected lesion.

Official Title
-----------------
Automatic Diagnosis of Spinal Stenosis on CT With Deep Learning

Conditions
-----------------
Spinal Stenosis

Intervention / Treatment
-----------------
* Diagnostic Test: deep learning


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >18 years with radiologists' CT reports on cervical, thoracic and lumbar stenosis Exclusion Criteria: not applicable (only specific levels with extensive infections, fractures, tumor, high-grade spondylolisthesis would be excluded for analysis).

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 |
| --- | --- |
| spinal stenosis<br>Spinal stenosis is a narrowing of the spaces within your spine, which can put pressure on the nerves that travel through the spine. Spinal stenosis occurs most often in the lower back and the neck. | Diagnostic Test: deep learning<br>* detect and classify spinal stenosis by deep learning<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diagnostic accuracy of deep learning | Diagnostic accuracy of deep learning to determine spinal stenosis compared with radiologists' labels based on CT | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic Performance of deep learning | Sensitivity, specificity, positive predictive value and negative predictive value of deep learning compared with radiologists' labels based on CT | 1 day |
Aldara for the Treatment of Large and/or Multiple sBCC

Study Overview
=================
Brief Summary
-----------------
BCC is the most common form of skin cancer. Current treatment is often surgery but this can be limited by the number of lesions, their location the age of the patient or the potential cosmetic outcome. The purpose of this study is to evaluate the effectiveness of imiquimod, on a non surgical treatment, in subjects with multiple of large sBCCs.

Official Title
-----------------
Open Study to Evaluate the Efficacy and Tolerance of Imiquimod 5% Cream for the Treatment of a Large and/or Multiple Superficial Basal Cell Carcinoma.

Conditions
-----------------
Carcinoma, Basal Cell

Intervention / Treatment
-----------------
* Drug: Imiquimod


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: One or more sBCC on torso, neck or face Total surface area <= 40 sq cm Exclusion Criteria: Pregnancy or women who are breastfeeding Xeroderma pigmentosum, albinism, epidermodysplasia verruciformis, any genetic anomaly accompanied by skin tumors Metatypical, adnexal, or sclerodermiform carcinomas Current or other previous malignant skin tumor (epidermoid carcinoma, melanoma) in the region of the current lesion Known HIV positive serology Skin tumor that is already or highly likely to become metastatic Presence of a clinically significant anomaly or illness (immunological, cardiovascular, pulmonary, hematological, neurological, hepatic, renal, endocrine, gastrointestinal, collagenous) Previous organ transplant history

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: imiqimod 5% cream<br> | Drug: Imiquimod<br>* cream 5%, 5 days out of seven, for 6 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical clearance of sBCC |  | 12 or 16 weeks after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in size of tumour |  | 12 or 16 weeks after treatment | 
| Rate of clearance, Cosmetic outcome |  | 12 or 16 weeks after treatment | 
| Sustained clearance rate over 3 year follow-up |  | 3 years after treatment | 
| Tolerability & QoL |  | 12 or 16 weeks after treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aldara, sBCC
Low Dose Continuous Administration of the Progesterone Receptor Modulator VA2914

Study Overview
=================
Brief Summary
-----------------
The purpose of the present study is to evaluate continuous administration of low doses of VA2914 for potential contraceptive activity and effects on the menstrual cycle and steroid hormone parameters.

Official Title
-----------------
Prospective Randomized Multicenter Phase II Study of the Dose-Response Effects of Continuous Administration of Low-Dose VA2914 on Parameters of the Hypothalamic-Pituitary-Gonadal Axis and the Endometrium

Conditions
-----------------
Contraception, Gynecologic Diseases

Intervention / Treatment
-----------------
* Drug: VA2914


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women in good general health with regular, ovulatory menstrual cycles age 18-35 not pregnant not sexually active or reliably use barrier methods of contraception normal liver and renal functions and normal laboratory exams Exclusion Criteria: pregnant or breastfeeding oral contraception, IUD or other hormonal treatment use of agents known to induce hepatic P450 cardiovascular disorder hepatic, renal, or gastrointestinal disorder metrorrhagia abnormal transvaginal ultrasound (at baseline) history of abnormal endometrial biopsy, cancer depression mental illness epilepsy migraines abnormal Pap Smear requiring further exploratory examination anovulatory cycle before treatment extreme overweight or underweight (body mass index < 16 ou >28) subjects unlikely to comply with the protocol, e.g., uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study use of narcotics more than 10 cigarettes per day, more than 2 glasses of wine/beer per day surgical procedures planned in the 6 months following screening visit

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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

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: VA2914|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ovarian hormones |  |  | 
| follicular development |  |  | 
| endometrial histology |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| menstural bleeding patterns |  |  | 
| cervical mucus |  |  | 
| VA2914 concentration |  |  | 
| adverse events |  |  | 
| laboratory parameters |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
progesterone receptor modulator
YKL-40 and Complications in Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
In this study, the investigators plan to establish the relationship between plasma concentration of YKL-40 with various vascular complications in the patients of type 2 diabetes.

Detailed Description
-----------------
It is well recognized now that diabetes mellitus is a systemic vasculopathy and causes various micro- and macrovascular complications. Vascular damage and endothelium dysfunction in diabetes mellitus involve a chronic inflammatory process via a complicated mechanism. YKL-40 is a 40 kD lectin molecule. It is secreted by various cells, including macrophages, vascular smooth muscle cells and giant cells, and the level of YKL-40 is found elevated in both acute (eg. infection) and chronic (eg. rheumatoid arthritis, systemic lupus erythematosus or cirrhosis of the liver) inflammatory processes. The plasma concentration of YKL-40 is elevated in the patients of type 2 diabetes mellitus compared with non-diabetic controls, and is associated with insulin resistance, fasting plasma glucose and plasma IL-6 concentrations. Furthermore, the concentration of YKL-40 is elevated and is associated with the severity of albuminuria in the patients of type 1 diabetes. The objective of this study is to establish the relationship between plasma concentration of YKL-40 with various vascular complications in the patients of type 2 diabetes, and to evaluate its potential as a biomarker for the vascular diabetic complications in patients with type 2 diabetes.

Official Title
-----------------
Association Study of the Plasma Concentration of YKL-40 and Vascular Complications in Patients With Type 2 Diabetes

Conditions
-----------------
Type 2 Diabetes Mellitus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clear consciousness type 2 diabetic patient
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Type 2 diabetes mellitus<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
-----------------
Type 2 diabetes mellitus, Diabetic complications, YKL-40
ERAS in Gastrointerstinal Fistulas.

Study Overview
=================
Brief Summary
-----------------
An enterocutaneous fistula (ECF) poses a major surgical problem. The definitive surgical repair of persistent fistulas remains a surgical challenge with a high rate of re-fistulation and mortality, and the reasons for that is not the surgical technique alone. Enhanced Recovery after Surgery (ERAS®) is an evidence-based multimodal perioperative protocol proven to reduce postoperative complications. The aim of the study was to assess the clinical value of ERAS protocol in surgical patients with ECF.

Detailed Description
-----------------
ERAS protocol was used in all patients scheduled for surgery for ECF at the Stanley Dudrick's Memorial Hospital in Skawina between 2011 and 2020. A multidisciplinary team (MDT) was in charge of the program and performed annual audits. A consecutive series of 100 ECF patients (44 F, 56 M, mean age 54.1) was evaluated. Postoperative complications rate, readmission rate, length of hospital stay, prevalence of postoperative nausea and vomiting were assessed.

Official Title
-----------------
Enhanced Recovery After Surgery (ERAS) Protocol is a Safe and Effective Approach in Patients With Gastrointestinal Fistulas Undergoing Reconstruction: Results From a Prospective Study.

Conditions
-----------------
Fistula, Surgery Site Fistula

Intervention / Treatment
-----------------
* Procedure: ERAS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: surgery for gastrointestinal fistula Exclusion Criteria: conservative treatment

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ERAS<br>Perioperative care with Enhanced Recovery After Surgery (ERAS) protocol | Procedure: ERAS<br>* Enhanced Recovery After Surgery (ERAS) protocol is an evidence-based multimodal perioperative protocol focused on stress reduction and the promotion of a return to function<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative complications | Any surgical complications | up to 24 weeks | 
| length of hospital stay | duration of hospitalization | up to 24 weeks | 
| postoperative nausea and vomiting | prevalence of postoperative nausea and vomiting | up to 24 weeks |
Causes and Management of Aseptic Meningitis : A Retrospective Cohort Study in Strasbourg University Hospital

Study Overview
=================
Brief Summary
-----------------
The diagnostic and therapeutic management of patients with aseptic meningitis is a challenge for the practitioner. There are many etiologies of this condition (infectious, inflammatory, neoplastic, drug-induced), which it is necessary to know how to evoke and look for specifically.

Official Title
-----------------
Causes and Management of Aseptic Meningitis : A Retrospective Cohort Study in Strasbourg University Hospital

Conditions
-----------------
Aseptic Meningitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Major subject (≥18 years old) Subject with aseptic meningitis (CSF pleocytosis, negative bacteriology) from January 2015 to October 2020, at HUS Subject having not expressed, after being informed, their opposition to the reuse of their data for the purposes of this research. Exclusion criteria: Subject who expressed their opposition to participating in the study Subject under guardianship or curatorship Subject under safeguard of justice Positive VZV, HSV, or Enterovirus PCR in CSF CSF analysis performed as part of the assessment of a known pathology Traumatic or surgical etiology

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 |
| --- | --- | --- |
| Retrospective study of the etiologies of aseptic meningitis infection in Alsace |  | Files analysed retrospectively from January 01, 2015 to October 31, 2020 will be examined | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aseptic Meningitis, Infectious, Inflammatory, Neoplastic, Drug-induced
Monitoring Growth of Preterm Infants

Study Overview
=================
Brief Summary
-----------------
Growth is poor in preterm infants, partly due to difficulty identifying when growth is slow. The investigators will examine the use of a computer program to try and identify periods of growth slowing in preterm babies, and compare those results to the usual assessments made on patient care rounds.

Detailed Description
-----------------
We wish to examine the use of a mathematical modeling system to see if it can detect poor growth better (and more quickly) than we can clinically. To do this, we need to know what the clinical team think about a baby's growth day-to-day. However, after rounds the fellow or NNP with fill in a sheet to say what the team thought about the baby's growth (was it okay, too slow, too fast etc.), and whether any changes were made to improve the baby's growth (e.g. increased feed volume, change in composition of feeds etc.). After the baby is discharged home, weight data from the EMR will be entered into the program to try and identify times where growth slowed (or where growth was faster than expected). We will compare the results of the computer program and the record of the clinical teams thoughts on the ward round, to see if the computer program identified growth slowing more quickly than the clinical team did.

Official Title
-----------------
Monitoring Growth of Preterm Infants

Conditions
-----------------
Prematurity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Birth weight < 1750g gestational age < 32w at birth Exclusion Criteria: Currently receiving parenteral nutrition or intravenous lipids
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Preterm infants<br>Preterm infants born at either <32 weeks gestation or < 1750g birth weight | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of growth slowing | At time of hospital discharge retrospectively collected data on daily weights (from the EMR) will be entered in to a computer program, to identify times where weight gain slowed significantly. This will be compared to the clinical assessment of the baby's growth made at the time (and recorded prospectively) | Between birth and hospital discharge, an average of 10weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Growth, weight