linjc16/ctgov huggingface dataset:
Use of rFXIII in Treatment of Congenital FXIII Deficiency, a Prospective Multi-centre Observational Study

Study Overview
=================
Brief Summary
-----------------
This study is conducted globally. The aim of this observational study is to investigate the incidence of specific adverse drug reactions associated with the use of recombinant factor XIII (NovoThirteen®) in patients with congenital FXIII A-subunit deficiency (congenital FXIII deficiency), comprising FXIII antibodies, allergic reactions, embolic and thrombotic events and lack of therapeutic effect. The study will aim at observing all patients exposed to NovoThirteen® in the EU, and additional patients from selected non-EU countries. Recombinant FXIII (rFXIII) is registered in EU and Switzerland as NovoThirteen® and in Canada as Tretten®.

Official Title
-----------------
Use of rFXIII in Treatment of Congenital FXIII Deficiency, a Prospective Multi-centre Observational Study

Conditions
-----------------
Congenital Bleeding Disorder, Congenital FXIII Deficiency

Intervention / Treatment
-----------------
* Drug: catridecacog


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed consent obtained before any study-related activities. (Study-related activities are any procedure related to recording of data according to the protocol) Able and willing to provide signed informed consent (or patient's legally acceptable representative (LAR) consent, if applicable), as required by local ethics committee, governmental or regulatory authorities Congenital FXIII A-subunit deficiency Actual or planned exposure to rFXIII
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| rFXIII<br> | Drug: catridecacog<br>* No treatment given. All patients enrolled in this observational study will receive their medication through usual commercial channels.<br>* Other names: recombinant factor XIII;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse drug reactions in patients with congenital FXIII A-subunit deficiency treated with rFXIII,comprising FXIII antibodies, allergic reactions, embolic and thrombotic events and lack of effect collected |  | During study period up to 6 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All serious adverse events collected |  | During study period up to 6 years | 
| All medical events of special interest collected |  | During study period up to 6 years | 
| All medication errors and near medication errors collected |  | During study period up to 6 years | 
| Use of rFXIII in patients with congenital FXIII A-subunit deficiency also for other uses than for prophylactic treatment collected |  | During study period up to 6 years | 
| Frequency of bleeding episodes collected |  | During study period up to 6 years |
Optimal Index for Pediatric Distal Forearm Fractures

Study Overview
=================
Brief Summary
-----------------
This is a prospective radiographic study of displaced distal forearm fractures requiring manipulation for children 3-12 years of age and will be treated with casting.The patients' full radiographic series (including the pre-manipulation, immediate post-manipulation, after 1 week and after 4 weeks radiographs) will be evaluated.

Official Title
-----------------
What is the Optimal Index for Assessment of Plaster Cast Quality in Pediatric Distal Forearm Fractures

Conditions
-----------------
Pediatric Distal Forearm Fractures

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males or females 3 to 12 years old. Any presentation of displaced distal forearm fractures requiring manipulation and will be treated with casting. Exclusion Criteria: Children with compound fractures (those with unacceptable initial reduction, fracture dislocations, and fractures with physeal separation) will be excluded from the study, as those will be treated with Kirschner wires. Children whose casts is split will be excluded.

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 12 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 |
| --- | --- | --- |
| The cast index | formula that use measurements obtained from anteroposterior and lateral plain radiographs to estimate the quality of cast placement. | 4 weeks observation after reduction and applying cast. | 
| The gap index | formula that use measurements obtained from anteroposterior and lateral plain radiographs to estimate the quality of cast placement. | 4 weeks observation after reduction and applying cast. | 
| The padding index | formula that use measurements obtained from anteroposterior and lateral plain radiographs to estimate the quality of cast placement. | 4 weeks observation after reduction and applying cast. | 
| The Canterbury index | formula that use measurements obtained from anteroposterior and lateral plain radiographs to estimate the quality of cast placement. | 4 weeks observation after reduction and applying cast. | 
| The three-point index |  | 4 weeks observation after reduction and applying cast. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Optimal index for Pediatric distal forearm fractures
Evaluation of a Training in the Walking With Exosquelette

Study Overview
=================
Brief Summary
-----------------
Stroke patients in the investigators rehabilitation unit follow gait trainings with robotic-assistive devices such as Lokomat. Patients able to walk alone are also assessed with 3D gait analysis. The objective of this study is to assess the effects of gait training in Lokomat on biomecanic gait parameters in stroke patients.

Conditions
-----------------
Gait, Stroke, Robotic Rehabilitation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: single stroke able to walk alone > 18years Exclusion Criteria: Cognitive impairments disturbing understanding Uncontrolled medical disorder associated

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 |
| --- | --- | --- |
| peak knee flexion (degrees) |  | participants will be followed for the duration of hospital stay, an expected average of 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hip and ankle kinematics (degrees) |  | participants will be followed for the duration of hospital stay, an expected average of 1 week | 
| kinetics (newton/meter) |  | participants will be followed for the duration of hospital stay, an expected average of 1 week | 
| spatio temporal parameter (m/s) |  | participants will be followed for the duration of hospital stay, an expected average of 1 week |
Lupus Flares and Histological Renal Activity at the End of the Treatment (LuFla)

Study Overview
=================
Brief Summary
-----------------
At this moment, the duration of the treatment in Proliferative Lupus Nephritis has not been determined. Almost 30 percent of patients in total remission during or after a treatment, will relapse in the first 5 years. The factors associated to Renal relapses are not completly known. The investigators think that an histological control study performed to patient with complete remission for a year at the end of a 3 years treatment could help us to know which patients are going to relapse.

Official Title
-----------------
Lupus Flares and Histological Renal Activity at the End of the Treatment

Conditions
-----------------
Lupus Nephritis

Intervention / Treatment
-----------------
* Procedure: Renal Biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria : Patients between 18 and 70 years old with Proliferative Lupus Nephritis 3 years treatment with a 6 month induction therapy and 2 years and a half of treatment maintenence Exclusion Criteria : Membranous Nephropaty Mesangial Nephropathy Less than 3 years treatment Less than 1 year of complete remission

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Renal Biopsy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal Flares | Renal relapse after a complete treatment in complete remission patients | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lupus Flare, Lupus Nephritis Treatment, Renal Biopsy in Lupus
Anecortave Acetate Risk Reduction Trial (AART)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate that Anecortave Acetate for Depot Suspension (15 mg or 30 mg) is safe and effective in arresting the progression of dry age-related macular degeneration (AMD) in patients who are at-risk for progressing to wet AMD.

Conditions
-----------------
AMD

Intervention / Treatment
-----------------
* Drug: Anecortave Acetate Sterile Suspension, 30 mg/mL
* Drug: Anecortave Acetate Sterile Suspension, 60 mg/mL
* Other: Anecortave Acetate Vehicle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Dry AMD in study eye, Wet AMD non-study eye. Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Under 50. Other protocol-defined exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anecortave Acetate, 15 mg<br>One 0.5 mL injection of 30 mg/mL Anecortave Acetate Sterile Suspension into the posterior juxtascleral depot (PJD) at 6-month intervals for 42 months. | Drug: Anecortave Acetate Sterile Suspension, 30 mg/mL<br>* One 0.5 mL injection into the PJD at 6-month intervals for 42 months<br>|
| Experimental: Anecortave Acetate, 30 mg<br>One 0.5 mL injection of 60 mg/mL Anecortave Acetate Sterile Suspension into the posterior juxtascleral depot (PJD) at 6-month intervals for 42 months. | Drug: Anecortave Acetate Sterile Suspension, 60 mg/mL<br>* One 0.5 mL injection into the PJD at 6-month intervals for 42 months<br>|
| Sham Comparator: Anecortave Acetate Vehicle<br>One sham injection at 6-month intervals for 42 months. Syringe and vehicle were not inserted into the eye. | Other: Anecortave Acetate Vehicle<br>* One 0.5 mL sham injection at 6-month intervals for 42 months. Syringe and vehicle were not inserted into the eye.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with sight-threatening choroidal neovascularization (CNV) in study eye |  | Month 48 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to development of sight-threatening CNV |  | Timepoint |
DPBRN Peri-operative Pain and Root Canal Therapy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to identify pre-operative factors that put patients at greater risk of developing severe tooth pain following root canal therapy, thereby providing evidence that will allow dentists to act preventively to lessen this risk, improve pain control, increase their patients' quality of life, and decrease the number of dental emergency interactions. A parallel goal of this study is to assess the feasibility of recruiting dentists that provide root canal therapy and patients using the DPBRN.

Detailed Description
-----------------
Goals for this study is to: Assess the frequency and intensity of pre-operative pain Evaluate the occurence and intensity of intra-operative pain Evaluate the occurence and intensity of post-operative pain Assess the interference of persistent tooth pain with daily life Identify a limited set of risk factors related to the development of post-operative pain.

Official Title
-----------------
Peri-operative Pain and Root Canal Therapy

Conditions
-----------------
Post-operative Tooth Pain, Root Canal Therapy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 19-70 years old permanent adult tooth requiring it first non-surgical root canal therapy patients with more than 1 tooth requiring root canal therapy are eligible, but only the first root canal procedure performed will be included to avoid problems of correlation within patients Exclusion Criteria: Evidence of prior root canal therapy, including iatrogenic, but not disease-induced, pulp access of the tooth being considered patients with obvious cognitive impairments (e.g., past stroke with communication deficits, dementia, mental disability) patients unable to return for 6 month follow-up, since another study plans to obtain data of these patients at that time (DPBRN Persistent Tooth Pain)

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 70 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Post-operativeTooth Pain<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
-----------------
Post-operative pain, intra-operative pain, root canal therapy, feasibility, post-surgical persistent pain
Evaluation of the Impact of Hospitalization in Intensive Care for COVID-19 Infection

Study Overview
=================
Brief Summary
-----------------
To evaluate the psychological, physical, social, professional and family impact of a hospitalization in intensive care for a covid 19 by analysis of the verbatim during a semi-structured interview.

Official Title
-----------------
Evaluation of the Impact of Hospitalization in Intensive Care for COVID-19 Infection

Conditions
-----------------
Covid19

Intervention / Treatment
-----------------
* Other: semi-directed entretien


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients hospitalized in intensive care at CH Dron for a COVID 19 who have given their agreement during their follow-up consultation Exclusion Criteria: Minor patient Patient does not speak French Refusal to participate

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: semi-directed entretien|semi-directed entretien|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychological impact of hospitalization in intensive care for a covid 19. | Frequency of recurring nightmares, irritability and anxious patient | At day 1 | 
| Physical impact of hospitalization in intensive care for a covid 19. | Frequency of Handicap and resumption of professional and personal activities | At day 1 |
A Study to Evaluate the Food Effect on the Pharmacokinetics of NVP-1203

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate food effect on the pharmacokinetics of NVP-1203

Detailed Description
-----------------
This study is designed as randomized, open-label, crossover assignment for evaluate the food effect on the pharmacokinetics of NVP-1203 in healthy adult subjects

Official Title
-----------------
Clinical Trial to Evaluate the Food Effect on the Pharmacokinetics of NVP-1203 in Healthy Adult Subjects

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

Intervention / Treatment
-----------------
* Drug: NVP-1203
* Drug: NVP-1203


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy adult subjects who signed informed consent Exclusion Criteria: Subjects has a history of allergy reaction of study drug ingredient Subjects participated in another clinical trial within 3 months prior to administration of the study drug Inadequate subject for the clinical trial by the investigator's decision

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NVP-1203(fed then fasting)<br>Subjects will receive a oral dose of NVP-1203 under fed conditions in period 1, then subjects will receive a oral dose of NVP-1203 under fasting conditions in period 2 | Drug: NVP-1203<br>* Oral<br>|
| Experimental: NVP-1203(fasting then fed)<br>Subjects will receive a oral dose of NVP-1203 under fasting conditions in period 1, then subjects will receive a oral dose of NVP-1203 under fed conditions in period 2 | Drug: NVP-1203<br>* Oral<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics : Cmax | Maximum plasma concentration | 0-24 hours | 
| Pharmacokinetics : AUCt | Area under the concentration-time curve | 0-24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics : AUCinf | AUC extrapolated to infinity | 0-24 hours | 
| Pharmacokinetics : Tmax | Time to reach the Cmax | 0-24 hours | 
| Pharmacokinetics : t1/2 | Terminal elimination half-life | 0-24 hours |
Analysis of the Mass Skiers' Injury in a Large Ski Resort in Chongli, China

Study Overview
=================
Brief Summary
-----------------
This study takes the injury situation of a large ski resort in Chongli during the 2017-2018 and 2018-2019 snow seasons as an example, aiming to preliminarily understand the injury situation of mass skiing in ski resorts in China, and provide a basis for predicting the rapidly growing medical demand for treatment and treatment of ski injuries in the context of 2022 Winter Olympic Games.

Detailed Description
-----------------
Objective: To make a retrospective analysis of the injuries of skiing population in a large ski resort in Chongli, China and provide a basis for predicting the rapidly increasing medical needs for ski injuries in the context of the 2022 winter Olympic Games. Methods: The basic data of all injured skiers who were treated in a medical station of a large ski resort in Chongli during the 2017-2018 and 2018-2019 snow seasons were collected. The number of skiers, the number of injuries, the causes of injuries, the types of injuries and the locations of injuries were compared.

Official Title
-----------------
Analysis of the Mass Skiers' Injury in a Large Ski Resort in Chongli, China

Conditions
-----------------
Skiing Injury

Intervention / Treatment
-----------------
* Other: Classification statistics


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All of the injured in a snow season at a snow resort Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 2017-2018 snow season<br>Injured skiers in the 2017-2018 snow season | Other: Classification statistics<br>* We classified skiers in the two snow seasons by injury site, type of injury, cause of injury, etc<br>|
| 2018-2019 snow season<br>Injured skiers in the 2018-2019 snow season | Other: Classification statistics<br>* We classified skiers in the two snow seasons by injury site, type of injury, cause of injury, etc<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Injury rate during the snow season | This study statistically analyzed the injury rates of the two snow seasons to see if there was any difference | Injury rate during a snow season,an average of 5 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ski resorts, Skiing, Sports injury, The winter Olympics