linjc16/ctgov huggingface dataset:
Development of the ICF Based Amputee Mobility Scale

Study Overview
=================
Brief Summary
-----------------
Lower limb amputation is a condition that reduces individuals' independence in daily life. Therefore, the main purpose of the rehabilitation process is to reintegrate the person as an independent and productive person as soon as possible. Although scales are frequently used in mobility evaluation in the clinic, they do not measure the advanced activities of patients. Therefore, the aim of the study is to obtain a comprehensive scale evaluating mobility in amputee. The mobility scale will be created using the two-round Delphi method. ICF (International Classification of Functioning Disability and Health) created by the World Health Organization, mobility subheading will be evaluated, and the questions that will be included in the scale will be compiled. In line with the data to be obtained from experts, a scale will be created.Scale and gold standard tests will be applied to patients so that validation of the scale will be investigated.

Official Title
-----------------
Development and Validation of the International Classification of Functioning Disability and Health (ICF) Based Amputee Mobility Scale

Conditions
-----------------
Amputation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Unilateral and traumatic lower limb loss Prosthesis use for at least 6 months Exclusion Criteria: Not speaking or understanding Turkish Not having cognitive skills to perform the tests

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 |
| --- | --- | --- |
| 2 Minute Walk Test |  | 3 March 2021 | 
| Amputee Mobility Predictor |  | 3 March 2021 |
Predictors of Atrial Fibrillation Recurrence After Ablation Using PENTARAY Catheter

Study Overview
=================
Brief Summary
-----------------
CARTO represent a new way of 3D electroanaromic mapping for AF which has improved safety and success rate of AF ablation compared with other conventional methods of AF ablation as it provide accurate visualization of atrial anatomy and identification of atrial substrate properties for catheter ablation of atrial arrythmias which ensure good ablation with decreased incidence of recurrence of AF.

Official Title
-----------------
Predictors of Atrial Fibrillation Recurrence After Ablation Using PENTARAY Catheter

Conditions
-----------------
Atrial Fibrillation Ablation Using PENTARAY Catheter

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with paroxismal AF who are eligible for AF ablation Patient resistant to medical treatment Exclusion Criteria: Patient with other types of arrythmias Patient with prothetic valves Patient with valvular AF
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 |
| --- | --- | --- |
| Maintenance of sinus rhythm after successful ablation of atrial fibrillation |  | 6 months after AF ablation |
An Observational Monocentric Study Investigating the Association Between Trough Serum Levels of Etanercept, Antibodies Towards Etanercept and Its Effectiveness in Psoriasis Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the association between trough serum levels of etanercept, antibodies towards etanercept and its effectiveness in psoriasis patients.

Official Title
-----------------
Intermittent Versus Continuous Treatment: an Observational Monocentric Study Investigating the Association Between Trough Levels of Enbrel and Therapy Regimen

Conditions
-----------------
Psoriasis

Intervention / Treatment
-----------------
* Drug: etanercept


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age from 18 years on, male or female Established diagnosis of psoriasis Etanercept either on monotherapy or in combination with acitretin (Neotigason®), given according to the current EU SmPC including the safety measures. Patients who give informed consent 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Psoriasis patients who receive Enbrel® therapy<br> | Drug: etanercept<br> <br> * Other names: Enbrel®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| trough serum etanercept concentration |  | one year | 
| anti-etanercept serum concentration |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
anti-TNF, therapeutic drug monitoring, immunogenicity
Serum Antimullerian Hormone Levels Among Epileptic Patients

Study Overview
=================
Brief Summary
-----------------
The production of AMH starts in granulosa cells before birth and the levels within the serum decreases towards the menapouse. The levels of AMH do not change throughout the menstruation cycle hovewer, it can be affected in cases related to body mass index (BMI), polycyctic ovarian syndrome (PCOS). The lower levels of AMH had been documented after ovarian surgery, radiotheraphy and chemotheraphy. AMH is a member of Transforming Growth Faktor β (TGF- β ) and it has receptors in brain structures including hyppocammpus. It is highly active neurophysiologically and it has a protective effect against N-methyl-D -aspartate related neuronal injury that is demonstrated both in vivo and in vitro studies. As a result, being a neuroactive hormone; AMH may have an effect on seizures within epileptic patients or serum AMH levels may be effected in epileptic patients when compared with healthy ones.

Official Title
-----------------
Investigation of Serum Antimullerian Hormone Levels in Adolescent Epilepsy Patients

Conditions
-----------------
Epilepsy, Reproductive Issues

Intervention / Treatment
-----------------
* Diagnostic Test: serum antimullerian hormone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy and epileptic volunteer females Ages between 12-18 After menarche Exclusion Criteria: ovarian surgery, history of radiotherapy history of chemotherapy, before menarche

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 18 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: two groups (epileptic and healthy participants)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: participants with epilepsy<br>healthy, menstruating females between 12-18 ages | Diagnostic Test: serum antimullerian hormone<br>* serum antimullerian hormone will be analyzed for all participants<br>|
| Other: healthy participants<br>epileptic, menstruating females between 12-18 ages | Diagnostic Test: serum antimullerian hormone<br>* serum antimullerian hormone will be analyzed for all participants<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum anti-mullerian hormone levels | The comparison of serum levels of anti-mullerian hormone between epileptic and healthy groups | baseline, at the time of examination | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
anti-mullerian hormone, epilepsy, adolescent
Prospective Evaluation of Adult Pulmonary Langerhans Cell Histiocytosis

Study Overview
=================
Brief Summary
-----------------
Study objectives: To estimate the incidence of pulmonary deterioration in adult pulmonary Langerhans cell histiocytosis To assess the impact of tobacco discontinuation Study Design Multicentric prospective cohort study Main endpoint: Pulmonary deterioration Sample size : 40 patients

Detailed Description
-----------------
Study objectives To estimate the incidence of pulmonary deterioration in adult pulmonary Langerhans cell histiocytosis To assess the impact of tobacco discontinuation Study Design Multicentric prospective cohort study Main endpoint: Pulmonary deterioration Sample size : 40 patients

Official Title
-----------------
Epidemiology of Adult Adult Pulmonary Langerhans Cell Histiocytosis - A Multicenter Cohort Study

Conditions
-----------------
Adult Pulmonary Langerhans Cell Histiocytosis

Intervention / Treatment
-----------------
* Behavioral: Tabacco discontinuation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pulmonary Langerhans cell histiocytosis diagnosed within the past 48 months Exclusion Criteria: Age < 18 Deep pulmonary dysfunction (CPT< 60%, FEV1< 30%, DLCO< 30%, partial pressure of oxygen in arterial blood (PaO2)< 60mmHg) No informed consent or consent withdrawal

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 |
| --- | --- |
| Histocytosis<br>Adult with isolated pulmonary Langerhans cell histiocytosis (pulmonary LCH) | Behavioral: Tabacco discontinuation<br>* Tabacco discontinuation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary deterioration | decrease in Forced expiratory volume in 1 second (FEV1), vital capacity (VC), or Diffusing capacity of the lung for carbon monoxide (DLCO) of at least 15% as compared to baseline values and/or progression of clinical symptoms (general symptoms) and/or occurrence of pneumothorax | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of pulmonary volumes (FEV1) |  | 6 months | 
| Evolution of pulmonary lesions in High Resolution Computed Tomography (HRCT) |  | 6 months |
The Effect of Extended Yellow Fever Vaccine Information on Symptom Reports Following Vaccination

Study Overview
=================
Brief Summary
-----------------
This study aims to investigate the effect of providing additional information about possible mild side effects of the yellow fever vaccination on the reporting of physical symptoms. Additionally, the project aims to investigate the relationship between individual characteristics (trait anxiety and perceived sensitivity to medication) and the reporting of physical symptoms, as well as possible interactions between the level of information provided and individual characteristics. We hypothesize that more information about mild symptoms provided to participants will increase the number of reported symptoms after vaccination.

Official Title
-----------------
The Effect of Extended Yellow Fever Vaccine Information on Symptom Reports Following Vaccination

Conditions
-----------------
Vaccination

Intervention / Treatment
-----------------
* Behavioral: Extended information on side effects


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Receiving yellow fever vaccination English speaker Aged over 18 Exclusion Criteria: No phone for follow-up

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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Provision of extended symptom side effects information | Behavioral: Extended information on side effects<br>* More detailed information on possible side effects of vaccine<br>|
| No Intervention: 2<br>Standard information on side effects | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| symptom report scale |  | 20 minutes and 1 week post vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| patient satisfaction scale |  | 20 minutes and 1 week post vaccination | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
yellow fever vaccine, patient information, symptom reports, patient satisfaction
Epidemiology of Fluoroquinolone Resistance in Human Commensal Flora in Patients Hospitalised in Medical Wards

Study Overview
=================
Brief Summary
-----------------
Emergence of bacterial resistance to antibiotics, which is a major public health issue, appears to involve predominantly commensal flora. No data exists concerning risk factors for the carriage of fluoroquinolone resistant bacteria in the flora of hospitalised patients. We will conduct a prospective open study including all unselected patients hospitalised in medical wards of one hospital. Nasal, pharyngeal and rectal swabs will be performed upon admission as well as a review of potential risk factors, after patient's information and acceptance. Resistance testing aiming 3 pathogens (Staphylococcus, Streptococcus and E. coli) will be performed on all specimens, and a case control study will compare risk factors from the resistant and non-resistant groups, for each pathogen. A thousand patients should be included in a year's time. This work could help understand risk factors involved in the carriage of fluoroquinolone resistant pathogens, potentially responsible for invasive infections and inter-patient transmission of resistance. Limiting bacterial resistance and transmission is a goal that can be successfully undertaken only if resistance mechanisms, but also risk factors of acquiring resistant bacteria are better understood.

Official Title
-----------------
Epidemiology and Risk Factors Study of the Carriage of Fluoroquinolone Resistant Bacteria in the Commensal Flora of Patients Hospitalised in Medical Wards

Conditions
-----------------
Colonization, Multi Drug Resistant Bacteria, Hospitalized Patients

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all adult patients admitted to the internal medicine, oncology, cardiology and geriatric unit of Beaujon Hospital, Clichy, France. patient agreement Exclusion Criteria: Age < 18 patient refusal or incapable

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 at hospital admission<br>Patients at hospital admission in medical wards on our tertiray care hospital (Hôpital Beaujon, Clichy, France). | |

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
-----------------
fluoroquinolone resistance, commensal flora, carriage
PVI for Prediction of Spinal Induced Hypotension

Study Overview
=================
Brief Summary
-----------------
The hypothesis is that plethysmography variability index can predict the occurrence of hypotension after spinal anesthesia for cesarean delivery

Official Title
-----------------
Can Plethysmography Variability Index (PVI) Predict Spinal Induced Hypotension in Women Undergoing Cesarean Delivery?

Conditions
-----------------
Spinal Induced Hypotension

Intervention / Treatment
-----------------
* Other: PVI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: English speaking ASA I-II non-laboring women with single gestations ≥36 weeks Scheduled or unscheduled cesarean delivery under spinal anesthesia Height: 5 feet-5 feet 11 in. Exclusion Criteria: Laboring women needing an emergency cesarean delivery Severe hypertensive disease of pregnancy defined as systolic blood pressure (SBP)>160mmHg, diastolic blood pressure (DBP)>110mmHg requiring antihypertensive treatment or associated with significant proteinuria. Severe Cardiac disease in pregnancy with marked functional limitations Diabetes type I Patients on Monoamine Oxidase Inhibitors or Tricyclic Antidepressants Inclusion in another anesthetic study involving drug administration.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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 |
| --- | --- |
| Women undergoing cesarean delivery under spinal anesthesia<br> | Other: PVI<br>* Measurement of PVI (plethysmography variability index)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between baseline PVI and change in SBP from baseline. | Correlation between baseline PVI and change in SBP from baseline. | Intraoperative (approximately 2 hours) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between plethysmography variability index (PVI) change in response to passive leg raising (PLR) and change in SBP and pulse rate (PR) from baseline, and need for vasopressors | Correlation between PVI change in response to PLR and change in SBP and pulse rate (PR) from baseline, and need for vasopressors | Intraoperative (approximately 2 hours) | 
| Correlation between intraoperative PVI change from baseline with change in SBP and PR from baseline, and need for vasopressors. |  | Intraoperative (approximately 2 hours) | 
| Correlation between baseline PVI and need for vasopressors. |  | Intraoperative (approximately 2 hours) | 
| Correlation between baseline PVI and change in SBP and PR from baseline. |  | Intraoperative (approximately 2 hours) | 
| Correlation between CO change in response to SLR with change in SBP and PR from baseline, and need for vasopressors |  | Intraoperative (approximately 2 hours) |
Intranasal Fentanyl in Treatment of Labour Pain

Study Overview
=================
Brief Summary
-----------------
Physiological changes during pregnancy are known to affect the pharmacokinetics of many drugs. Intranasal fentanyl is an interesting option for obstetric analgesia, but its use in pregnant patients has not been established. The investigators studied pharmacokinetics of intranasal fentanyl in labouring women and to subsequently evaluate the maternal and fetal safety after administration.

Official Title
-----------------
Intranasal Fentanyl in Treatment of Labour Pain - Efficacy and Safety

Conditions
-----------------
Labor Pain

Intervention / Treatment
-----------------
* Drug: intranasal fentanyl 50 microg dose up to 250 microg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy parturients with uncomplicated, single gestation pregnancies, full term (38-42 weeks of gestation) pregnancy, agreed to participate Exclusion Criteria: a disease that might affect hepatic or renal function, contraindications to opioid analgesics, fetal growth retardation, signs of fetal asphyxia by cardiotocography, meconium stained amniotic fluid or placental insufficiency. The subjects should not have received fentanyl during the previous 14 days. Not agreed to participate

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Intranasal fentanyl
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intranasal fentanyl 50 microg/dose<br>patient was given intranasal fentanyl 50 microg/dose up to 250 microg | Drug: intranasal fentanyl 50 microg dose up to 250 microg<br>* When contraction pain was ≥ 5/10 (numerical rating scale 0= no pain, 10= worst pain), the parturient was given a intranasal fentanyl 50 µg dose. After 15 minutes, if contraction pain was still ≥ 5/10, a second 50 µg intranasal dose was administered. Fentanyl was administered every 15 minute until contraction pain decreased to less than 5/10 or until the maximum fentanyl dose of 250 µg was administered.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fentanyl maximum concentration |  | From the first intranasal fentanyl dose to birth of the newborn up to 48 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Labor pain, Fentanyl, Transmucosal