linjc16/ctgov huggingface dataset:
Interference by Activated Protein C Resistance in the Determination of Protein S Activity

Study Overview
=================
Brief Summary
-----------------
Protein S is an anticoagulant protein and a cofactor of protein C. It is recommended to explore it first by a functional (chronometric) technique by assessing its cofactor activity of activated protein C. Existing tests measure the prolongation of a coagulation time. These tests are all dependent on factor V, but some patients have mutations in factor V (including V Leiden) that make them resistant to activated protein C activity. It is suspected that these mutations lead to underestimations of protein S activity by chronometric technique.

Official Title
-----------------
Interference by Activated Protein C Resistance in the Determination of Protein S Activity

Conditions
-----------------
Resistance to Activated Protein C in the Determination of Protein S Activity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patient of legal age (≥ 18 years) Patient for whom a sample has been sent to the HUS Hematology Laboratory for measurement of protein S activity between 28/12/2009 and 29/12/2020 Patient who does not object to the reuse of his/her medical data for scientific research purposes. Exclusion criteria: Minor patient Patient with incomplete data

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 |
| --- | --- | --- |
| Functional test protein C resistance |  | Through study completion, an average of 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
protein C, protein S, activated protein C
Evaluation of Target Organs Impairment on Patients Suffering From High Blood Pressure

Study Overview
=================
Brief Summary
-----------------
Evaluation of target organs impairment on patients suffering from high blood pressure without known cardio vascular or renal disease, stratified on blood pressure control.

Official Title
-----------------
Evaluation of Target Organs Impairment on Patients Suffering From High Blood Pressure Without Known Cardio Vascular or Renal Disease, Stratified on Blood Pressure Control.

Conditions
-----------------
Blood Pressure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults with hypertension (treated or not), without known cardiovascular or renal disease.

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 |
| --- | --- |
| 1<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the frequency of evaluation of target organs preclinical impairment on patients without known cardiovascular or renal disease, taking into consideration the blood pressure level (controlled HBP or not) |  | Once | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Target organs impairment, High blood pressure, Evaluation of target organs impairment on patients suffering from high blood pressure without known cardiovascular or renal disease
Upper Limb Evaluation in Non Ambulatory Patients With Neuromuscular Disorder

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate different devices to quantify upper limb function (Motriplate) and strength (Myogrip, Myopinch) in non-ambulatory patients with neuromuscular disorder. Motriplate measures the ability of the patient to reproduce a repetitive movement of the wrist to push two 5cm*5cm targets during 30 seconds. One hundred patients aged 8-30 years and 60 controls will be evaluated during twelve months (M0, M6 and M12) with theses new tools, and results will be compared to other testing, such as wrist, grip and pinch strength, taping, MFM measurement, and self evaluation of hand ability.

Official Title
-----------------
Development and Evaluation of a Clinical Test in Order Quantify Muscular Function in Upper Limb of Non Ambulatory Patients With Neuromuscular Disorder

Conditions
-----------------
Neuromuscular Disorders

Intervention / Treatment
-----------------
* Device: Motriplate
* Device: Motriplate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed neuromuscular disorder Aged 8-30 years Written consent Non ambulant Exclusion Criteria Major cognitive impairment Inability to stay seated one hour Recent upper limb surgery or trauma Treatment by steroids initiated less than 6 months before

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 30 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: patients<br>Patients with neuromuscular disorder and controls | Device: Motriplate<br>* Number of contact couples<br>|
| Experimental: Controls<br>healthy controls | Device: Motriplate<br>* Number of contact couples<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of contact couples with the targets |  | Month 0, Day 60, Month 6, Month 12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Neuromuscular disorders, Evaluation, Strength, Upper limb
Evaluate the Efficacy and Safety of DWP05195 in Subjects With Post-Herpetic Neuralgia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate efficacy, safety of administered DWP05195 in Postherpetic Neuralgia.

Official Title
-----------------
The Clinical Trial for Evaluation of Efficacy and Safety of DWP05195 in Postherpetic Neuralgia: Double-blind, Placebo-controlled, Randomized, Multi-center, Exploratory Clinical Trial

Conditions
-----------------
Postherpetic Neuralgia

Intervention / Treatment
-----------------
* Drug: DWP05195
* Drug: DWP05195
* Drug: DWP05195
* Drug: Control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or Female subjects aged 20 to 80 years Subjects with symptoms of neuropathic pain associated with postherpetic neuralgia(PHN). Subjects must have pain present for > 3 months after healing of the acute herpes zoster skin rash. Exclusion Criteria: Other severe pain that may potentially confound pain assessment. Subjects with symptoms of neuropathic pain applied Medical Equipment Within 2 years: Subjects were diagnosed with cancer

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment A<br> | Drug: DWP05195<br>* Tablets, oral administration, 100mg<br>|
| Experimental: Treatment B<br> | Drug: DWP05195<br>* Tablets, oral administration, 200mg<br>|
| Experimental: Treatment C<br> | Drug: DWP05195<br>* Tablets, oral administration, 300mg<br>|
| Placebo Comparator: Treatment D<br> | Drug: Control<br>* Tablets, oral administration, Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endpoint change from the baseline after administered 8 weeks mean pain score based on the Numerical pain Rating Scale(NPRS) from the subject's daily pain diary |  | 8 weeks |
EMINEM: Efficacy of Muscoril In NEck Myofascial Syndromes

Study Overview
=================
Brief Summary
-----------------
Study objective: To demonstrate, in patients with myofascial pain syndrome in cervical region, the degree of efficacy of thiocolchicoside ointment administered to trigger point regions compared with the trigger point injection.

Official Title
-----------------
The Efficacy of Topical Thiocolchicoside in Cervical Myofascial Pain Syndrome: Triple-Arm, Single-Blind, Randomized, Prospective, Phase IV Clinical Study

Conditions
-----------------
Myofascial Pain Syndromes

Intervention / Treatment
-----------------
* Drug: Thiocolchicoside


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Submitted to clinic with a complaint of head and neck pain Be diagnosed as having myofascial pain syndrome by determining the active trigger points in trapezius and/or interscapular region according to criteria of Simons and Travel Have 1 to 8 active trigger point(s) Exclusion Criteria: Have evident cervical discopathy and signs of osteoarthritis Have bleeding diathesis or using anticoagulant medication which hinders injection Have known malignity, being used steroids, have immunodepressive disorders and/or being taken immunodepressive drugs Be pregnant or have the possibility of being pregnant or not being used a regular contraceptive method Have known allergic reaction against Thiocolchicoside

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Thiocolchicoside|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain relief (Visual Analog Scale and sensitometer) and increase in mobility of neck. Patient and physician satisfaction |  |  |
Teneligliptin and Atorvastatin DDI Study

Study Overview
=================
Brief Summary
-----------------
A randomized, open-label, cross-over, multiple dosing study to evaluate drug-drug interaction between Teneligliptin and Atorvastatin in healthy male adults

Official Title
-----------------
A Randomized, Open-label, Cross-over, Multiple Dosing Study to Evaluate Drug-drug Interaction Between Teneligliptin and Atorvastatin in Healthy Male Adults

Conditions
-----------------
Diabete Mellitus

Intervention / Treatment
-----------------
* Drug: Teneligliptin 20mg/day
* Drug: Atorvastatin 40mg/Day
* Drug: Teneligliptin 20mg/day + Atorvastatin 40mg/day


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male adult 19 to 45 years Body weight ≥ 50kg, and BMI between 18-29kg/m2 at screening Subject who agrees to use a medically acceptable double-barrier method of contraception and not to donate sperms from the first dose until 2 months after the last dose. Subject who was given, and fully understood, the information about the study, and has provided voluntary written informed consent to participate in the study and agreed to comply with the study requirements.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Teneligliptin<br> | Drug: Teneligliptin 20mg/day<br>* cross-over<br>|
| Other: Atorvastatin<br> | Drug: Atorvastatin 40mg/Day<br>* cross-over<br>|
| Other: Teneligliptin + Atorvastatin<br> | Drug: Teneligliptin 20mg/day + Atorvastatin 40mg/day<br>* cross-over<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax,ss(Maximum concentration at steady state) |  | 24 hours | 
| AUCτ,ss(Area under the concentration-time curve at steady state) |  | 24hours |
Effect of Sedatives on Regional Cerebral Oxygen Saturation

Study Overview
=================
Brief Summary
-----------------
Compare the changes of regional cerebral oxygen saturation during midazolam or dexmedetomidine sedation for spinal anesthesia in the elderly patients who undergoing femur surgery.

Detailed Description
-----------------
Compare the changes of regional cerebral oxygen saturation during midazolam or dexmedetomidine administration (target bispectrl index 75-80) for spinal anesthesia in the elderly patients over 65 years who undergoing femur surgery.

Official Title
-----------------
Effect of Medazolam or Dexmedetomidine on Regional Cerebral Oxygen Saturation During Spinal Anesthesia in the Elderly Patients

Conditions
-----------------
Cerebral Ischemia-Hypoxia

Intervention / Treatment
-----------------
* Drug: Midazolam
* Drug: Dexmedetomidine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patinets who undergoing femur surgery under spinal anesthesia Exclusion Criteria: previous cerebrovascular disease, uncontrolled cardiovascular disorder, uncontrolled pulmonary disease

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: midazolam<br>administration of midazolam during spinal anesthesia for target bispectral index 75-80 | Drug: Midazolam<br>* administration of midazolam during spinal anesthesia for target bispectral index 75-80<br>* Other names: Mida;|
| Active Comparator: dexmedetomidine<br>administration of dexmedeomidine during spinal anesthesia for target bispectral index 75-80 | Drug: Dexmedetomidine<br>* administration of dexmedetomidine during spinal anesthesia for target bispectral index 75-80<br>* Other names: Dex;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| regional cerebral oxygen saturation |  | 1 day |
Effects of Increased CF-LVAD Pump Speed During Sustained Submaximal Exercise

Study Overview
=================
Brief Summary
-----------------
This randomized trial has been designed to study if it is possible to enhance work capacity during submaximal efforts in heart failure patients supported with continuous-flow left ventricular assist devices (CF-LVAD). The hypothesis is that exercise tolerability during low to moderate workloads in CF-LVAD patients can be increased when pump speed is increased soon after the onset of exercise.

Detailed Description
-----------------
To test the hypothesis described above the investigators will study submaximal exercise tests below anaerobic threshold in patients supported with CF-LVADs.Each patient will perform two tests- one with baseline CF-LVAD pump speed and the other with incrementally increased pump speed.

Official Title
-----------------
Improving Functional Capacity in Heart Failure Patients Supported With Continuous-flow Left Ventricular Assist Devices. -Effects of Increased Pump Speed During Sustained Submaximal Exercise

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Other: CF-LVAD pump speed baseline.
* Other: CF-LVAD pump speed increased.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ischemic and non-ischemic cardiomyopathy patients with CF-LVADs,signed informed consent. Exclusion Criteria: Unstable patients, CF-LVAD implantation less than three months ago.

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

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CF-LVAD patients.<br>Patients are compared with themselves during submaximal exercise testing with baseline pump speed vs. submaximal exercise testing with increased pump speed. | Other: CF-LVAD pump speed baseline.<br>* Submaximal exercise test with baseline pump speed.<br>Other: CF-LVAD pump speed increased.<br>* Submaximal exercise test with increased pump speed (+800RPM).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exercise time | Exercise will be performed on a upright ergometer bike with simultaneously breath-by-breath gaz analysis. | Exercise time will be estimated only on the day of the study. No follow-up. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived exertion | Rate of exertion will be estimated using the Borg Scale. | Perceived exertion will be estimated during exercise on the ergometer bike on the day of the study. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heart-assist devices, exercise capacity
Ledderhose Disease - Long Term Effects of Radiotherapy Treatment. LedRad LTE - Study

Study Overview
=================
Brief Summary
-----------------
The aim of the LedRad LTE study is to determine the current complaints, late side effects and satisfaction of patients who were treated with radiotherapy for Ledderhose disease at least two years ago.

Official Title
-----------------
Ledderhose Disease - Long Term Effects of Radiotherapy Treatment. LedRad LTE - Study

Conditions
-----------------
Ledderhose Disease

Intervention / Treatment
-----------------
* Radiation: Radiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Patients treated with radiotherapy for Ledderhose disease at the UMCG at least 2 years ago

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

| Intervention/Treatment |
| --- |
|Radiation: Radiotherapy|Patients who received a total dose of 30 Gy|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Current pain | Determine pain with the numeric rating scale. A 11-point pain scale ranging from 0=no pain to 10=worst pain | at least 2 years after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Worst pain | Determine pain with the numeric rating scale. A 11-point pain scale ranging from 0=no pain to 10=worst pain | at least 2 years after treatment | 
| Quality of Life | Assess the impact on quality of life of the treatment with radiotherapy for this study population with the EURO-Qol-5D-5L | at least 2 years after treatment | 
| Late side effects of treatment | Is treatment still effective and/or are there any (unknown) side effects of treatment | at least 2 years after treatment | 
| Satisfaction with radiotherapy treatment for Ledderhose disease | Determine patient satisfaction with the radiotherapy treatment for Ledderhose disease using a self developed questionnaire | at least 2 years after treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Radiotherapy, Pain, Side effect, Satisfaction
PrEP Among MSM and TG in Myanmar

Study Overview
=================
Brief Summary
-----------------
HIV is concentrated among key populations in Myanmar. Globally, HIV-prevalence among transgender (TG) women is one of the highest; laboratory-confirmed prevalence is reported up to 40%. In September 2015, WHO recommended the use of Pre-Exposure Prophylaxis (PrEP) for people at substantial risk of HIV as part of a combination HIV prevention strategy. A demonstration project will take place to implement and evaluate the uptake and effectiveness of PrEP among MSM, and TG women in a clinic in Hlaingtharyar township, Yangon. The aim is to describe PrEP uptake, as well as HIV-seroconversion and STI infection rates among those who use PrEP.

Official Title
-----------------
Pre-exposure Prophylaxis of HIV Infection Among Men Who Have Sex With Men (MSM) and Transgender Women (TG) in Suburban Yangon, Myanmar

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: Tenofovir Disoproxil Fumarate (TDF) 300 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV-negative No suspicion of acute HIV infection Substantial risk of HIV infection Creatinine clearance is more than 30 ml/min Willingness to use PrEP as prescribed, including periodic HIV testing Willingness to sign informed consent Exclusion Criteria: • Anyone who is not eligible with the inclusion criteria
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HIV-negative MSM/TG<br>Oral pre-exposure prophylaxis (PrEP) will be offered to HIV negative MSM, TG identified to be at substantial risk for HIV infection and those motivated to take daily PrEP. | Drug: Tenofovir Disoproxil Fumarate (TDF) 300 mg<br>* PrEP regimens of Tenofovir Disoproxil Fumarate (TDF) 300 mg/Lamivudine (3TC) 300mg per oral (PO) daily<br>* Other names: Lamivudine (3TC) 300mg;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uptake rate of PrEP | The proportion of HIV-negative MSM and TG women who are taking PrEP among those who are eligible to take PrEP. | through study completion, an average of 1 year | 
| HIV seroconversion rate among PrEP user | The portion of PrEP taking HIV negative MSM and TG women who become HIV positive while he is taking PrEP among those who are taking PrEP. | through study completion, an average of 1 year | 
| STI infection rates among PrEP user(Syphilis test, Gram stain for gonorrhoea and Xpert CT/NG) | The number of positive episodes for either syphilis or gonorrhea or chlamydia infection among the PrEP taking MSM and Transgender women per number of testing among them. | through study completion, an average of 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pre-exposure prophylaxis of HIV infection, PrEP, MSM, TG