linjc16/ctgov huggingface dataset:
Efficacy and Safety of Rasagiline in Prodromal Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
To investigate whether a year of rasagiline may reduce the progression from idiopathic REM sleep behavior disorder (RBD) to Parkinson's disease (PD).

Official Title
-----------------
Efficacy and Safety of Rasagiline in Prodromal Parkinson's Disease

Conditions
-----------------
REM Sleep Behavior Disorder, Parkinson Disease, Synucleinopathies

Intervention / Treatment
-----------------
* Drug: Rasagiline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PSG confirmed RBD with subtle motor symptoms (4≤MDS-UPDRS-III≤10 at baseline) no clinical diagnosis of Parkinson's disease or dementia at baseline age 30-75 no concomitant or previous use of any other anti-parkinson medications provide written informed consent Exclusion Criteria: diagnosed with secondary parkinsonism (eg., drug-induced, vascular, psychogenic) secondary RBD (eg., drug-induced, immune-mediated) nervous system comorbidities (eg., stroke, epilepsy, encephalitis) severe psychiatric comorbidities allergic to rasagiline severe systemic diseases (eg., end-stage kidney disease, liver failure)

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 75 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early Intervention<br>0-52 week: rasagiline 1 mg/day | Drug: Rasagiline<br>* 1 mg rasagiline<br>|
| Active Comparator: Delayed Intervention<br>0-26 week: palcebo 1mg/day 27-52 week: rasagiline 1mg/day | Drug: Rasagiline<br>* 1 mg rasagiline<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease-free survival time | Not diagnosed as any of the synucleinopathies (Parkinson's disease; dementia with lewy body; multiple system atrophy) | 3 years after starting rasagiline treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Striatal dopaminergic innervation | Striatal binding ratio from DAT-Scan | 0-3 years after starting rasagiline treatment | 
| MDS-UPDRS-III |  | 0-3 years after starting rasagiline treatment | 
| MoCA |  | 0-3 years after starting rasagiline treatment | 
| MMSE |  | 0-3 years after starting rasagiline treatment | 
| HAMA |  | 0-3 years after starting rasagiline treatment | 
| HAMD |  | 0-3 years after starting rasagiline treatment | 
| RBDQ-HK |  | 0-3 years after starting rasagiline treatment | 
| PSQI |  | 0-3 years after starting rasagiline treatment | 
| PDQ39 |  | 0-3 years after starting rasagiline treatment | 
| SCOPA-AUT |  | 0-3 years after starting rasagiline treatment |
Backpack Load and Spine Muscles Activity

Study Overview
=================
Brief Summary
-----------------
The purpose of the present study is to analyze the influence of four backpack loading conditions (0, 10, 15 and 20% of body weight) on the electromyographic activity of the neck and lumbar muscles of elementary school children.

Detailed Description
-----------------
Elementary school children participated in the present study, between the ages of 6 and 10. Bilateral sternocleidomastoid, rectus abdominis and erector spinae muscles activity were recorded using surface electromyography (sEMG), while tested for the effect of four randomized backpack loading conditions.

Official Title
-----------------
Influence of Different Backpack Loading Conditions on Neck and Lumbar Muscles Activity of Elementary School Children

Conditions
-----------------
Child

Intervention / Treatment
-----------------
* Other: loading conditions


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children with tutor consent Exclusion Criteria: children with cognitive impairment

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 10 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy school children<br>elementary school children will be presented with different backpack loading conditions | Other: loading conditions<br>* Different backpack loading conditions 0%, 10%, 15% and 20% allocated randomly<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle Activity as a Measure of Route Mean Square | EMG signals were initially filtered with a Notch Filter of 50hz, due to the DC power line, using MATLAB 7.11 (v.2010). The signal was then detrended, converted into millivolts and normalized. the normalized signal was then used to calculate the route mean square. | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Surface electromyography, children, backpack
Pathogen Detection in Infectious Uveitis

Study Overview
=================
Brief Summary
-----------------
Infectious uveitis is a very important blinding disease. Some people who have been diagnosed with idiopathic uveitis may also have the activity of pathogens in the eye. However, due to the limitation of the amount of ocular samples, it is difficult to make a rapid and effective diagnosis of infection.Current study is to explore the infective cause of uveitis in China by using a broad diagnostic approach of detection.

Detailed Description
-----------------
Infectious uveitis is a very important blinding disease. Some people who have been diagnosed with idiopathic uveitis may also have the activity of pathogens in the eye. However, due to the limitation of the amount of ocular samples, it is difficult to make a rapid and effective diagnosis of infection. The study is to explore the infective cause of uveitis in China by using a broad diagnostic approach of detection, including multiple molecular bio-techniques. We also plan to explore the distribution of pathogens in infectious uveitis.

Official Title
-----------------
Pathogen Detection in Infectious Uveitis in China

Conditions
-----------------
Infectious Panuveitis, Infectious Iridocyclitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient at a referal hospital eye clinic with clinically suspected infectious uveitis Exclusion Criteria: Patients not eligible for the Inclusion Criteria Confirmed auto-immune uveitis
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 |
| --- | --- |
| infectious uveitis<br>Patients suffering from suspected infectious uveitis, who have vitrectomy performed for diagnostic purpose or anterior chamber tap | |
| Control group<br>Patients suffering from either cataract surgery or vitrectomy who has been ruled out for infectious ocular diseases | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence and distribution of intraocular infections in the study group | Prevalence and distribution of intraocular infections in the study group | Oct 2020 to Sep 2022 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The sensitivity and specificity of multiple molecular diagnostic methods for detection of bacteria or virus fungi in the study group | The sensitivity and specificity of multiple molecular diagnostic methods for detection of bacteria or virus fungi in the study group | Oct 2020 to Sep 2022 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
infectious uveitis, pathogen, PCR
Fluid Balance During Surgery for Ovarian Cancer

Study Overview
=================
Brief Summary
-----------------
Extensive tumour debulking challenges both surgeon and anaesthesiologist but promotes survival in late-stage ovarian cancer patients. Little is known about the intraoperative fluid balance and its impact on morbidity and mortality.

Official Title
-----------------
Intraoperative Fluid Balance During Cytoreductive Surgery for Ovarian Cancer

Conditions
-----------------
Ovarian Neoplasm, Fluid Therapy

Intervention / Treatment
-----------------
* Procedure: Cytoreductive surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients scheduled for cytoreductive surgery in ovarian cancer Exclusion Criteria: Age < 18 years unability to give consent

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Cytoreductive surgery|Cytoreductive surgery in terms of tumor debulking is performed in order to promote survival|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fluid balance | intraoperative fluid balance is determined by the difference between fluid intake and outtake | at the end of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mechanical ventilation | Duration of mechanical ventilation, starting from endotracheal intubation until extubation | at the timepoint of extubation | 
| mortality | long-term mortality after surgery | 5 years |
Differential Diagnosis and Cause-specific Treatment During OHCA

Study Overview
=================
Brief Summary
-----------------
Differential diagnosis: ultrasound, blood gas analyse combined with examination of the patient and environment is used during Out Of Hospital Cardiac Arrest (OHCA) to screen possible underlying cause of cardiac arrest. Helicopter Emergency Medical Service (HEMS) in Helsinki has unraveled a protocol for performing differential diagnosis during OHCA. Our study aim is to test the feasibility of this protocol. Our study is a prospective medical record based study. The anesthesiologist operating in the HEMS unit fills a form after encounter of OHCA. Questioners focus on how long did execution of the protocol take, and the cause if the protocol was not completed.

Official Title
-----------------
Differential Diagnosis and Cause-specific Treatment During OHCA - a Prospective Feasibility Study

Conditions
-----------------
Out-Of-Hospital Cardiac Arrest

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: non-traumatic out-of-hospital cardiac arrest encountered by the helicopter emergency medical services team Exclusion Criteria: return of spontaneous circulation before HEMS crew arrival termination of resuscitation attempt before HEMS crew arrival
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 |
| --- | --- | --- |
| Successful execution of differential diagnosis protocol | Successful and all-inclusive execution of the following items during cardiopulmonary resuscitation: ultrasound examination, arterial blood gas analyze, clinical examination, obtaining structured history from next of kin and searching of the environment. | 60 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of cause-specific treatment during resuscitation | Any therapy given as a treatment of presumed reversible cause of a cardiac arrest (excluding chest-compressions, ventilation, airway management, oxygen, epinephrine, amiodarone and defibrillation) | 60 minutes | 
| Time needed to complete the differential diagnostics protocol | Delay from patient encountered by the prehospital critical care physician to the all diagnostics performed (during cardiopulmonary resuscitation) | 60 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
out of hospital cardiac arrest, differential diagnosis, prospective, ultrasound, blood gas analyse
A Bioequivalence Study of Two Different Dosages of Isoniazid Tablet Formulations in Human Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
The recommended treatment for latent tuberculosis infection for adults is a daily dose of isoniazid 300mg during 6 months. In Brazil, isoniazid was formulated as 100 mg tables. The treatment duration and the high pill burden compromised patient adherence to the treatment. The Brazilian National Programme for Tuberculosis requested the development of a new 300mg isoniazid formulation. The aim of the study is to compare the bioavailability of the isoniazid 300mg new formulation and three 100mg tablets of the reference formulation. The study is a randomized, single dose, open label, fasting, two-phase crossover bioequivalence study with a wash out period of 7 days (>7 half-life) in 28 healthy human volunteers. For the determination of isoniazid in human plasma, the investigators developed and validated a sensitive, simple and rapid HPLC-MS/MS method. This will support the strategy adopted by the Brazilian National Program for Tuberculosis for the treatment of latent tuberculosis. The new formulation will increase patients' adherence to the treatment and quality of life. Medical doctors in Brazil should become aware of the new formulation and the new treatment strategy in order to prescribe the right medication and avoid errors that could result in a high frequency of adverse events. Future research studies should evaluate pharmacovigilance, acceptability of the new tablet formulation and its impact on the cure rate.

Official Title
-----------------
New Strategy for Treating Latent Tuberculosis Infection in Brazil: A Bioequivalence Study of Two Different Dosages of Isoniazid Tablet Formulations in Human Healthy Volunteers

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

Intervention / Treatment
-----------------
* Drug: Isoniazida


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy men and women aged between 18 and 50 years BMI between 18.5 and 29.9 kg/m²

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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 |
| --- | --- |
| Active Comparator: Isoniazida-LAQFA®<br>3 coated tablet of 100mg | Drug: Isoniazida<br> <br> |
| Experimental: Isoniazida<br>coated tablet of 300mg | Drug: Isoniazida<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average bioequivalence based on the 90% CI | The 90% confidence interval for isoniazid log transformed Cmax and AUC0-t should be within the accepted bioequivalence range 80.00-125.00% for Cmax and AUC0-t of isoniazid. | up to 6 months |
A Preliminary Clinical Study to Evaluate Fispemifene in the Treatment of Hypogonadism

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether one or more fispemifene dose regimens are more effective than placebo in the treatment of hypogonadism in older men.

Official Title
-----------------
Preliminary Efficacy and Safety of Fispemifene in the Treatment of Hypogonadism: A 4 Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Comparing Daily Oral Doses of 100, 200, and 300 mg Fispemifene and Placebo

Conditions
-----------------
Hypogonadism

Intervention / Treatment
-----------------
* Drug: Fispemifene once daily for 4 weeks


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Total testosterone level <240 ng/dL Serum LH and FSH levels within normal limits Exclusion Criteria: Elevated prolactin Evidence of Benign Prostatic Hypertrophy History of or current breast cancer, prostate cancer, abnormal DRE or elevated PSA or any other malignancy Clinically significant endocrine/metabolic or cardiovascular disease Significant polycythemia

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

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

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: Fispemifene once daily for 4 weeks|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in morning total testosterone levels from baseline to Week 4 (end of therapy) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in total testosterone levels from baseline to Weeks 2 and 6 |  |  | 
| Change in free testosterone, calculated free testosterone, and DHT from baseline to Weeks 2, 4, and 6 |  |  | 
| Change in SHBG, E2, LH, FSH and inhibin B from baseline to Weeks 2, 4, and 6 |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypogonadism, Testosterone
Patient's Knowledge on Their Anticoagulating and Anti Platelet Treatment St Joseph's Hospital)

Study Overview
=================
Brief Summary
-----------------
Oral antigoagulant are used more than 60 years in thrombotic diseases. Even they are indispensable, the haemorragic risk is high.That's why it's the main reason of hospitalization for iatrogeny.The complication's reasons are mainly linked to errors of drug intake, drugs interaction and the lack of understanding the treatment.Moreover, the antiplatelet agglutening treatment is frequently added to anticoagulant treatment.This increases the haemorragic risk.Different means were used to minimize the risk , like INR follow up. The purpose of the study is to evaluate smartphone use to follow the patients'treatment.

Detailed Description
-----------------
Two questionnaire via smartphone with 15 days gap.

Official Title
-----------------
Current Situation of the Patient's Knowledge on Their Anticoagulating and Anti Platelet Treatment in GHPSJ (St Joseph's Hospital)

Conditions
-----------------
Coagulation Disorder

Intervention / Treatment
-----------------
* Other: questionnaire via smartphone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient under ant-thrombotic treatment hospitalized in vascular medecine service Exclusion Criteria: refusing the participation

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: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: questionnaire via smartphone|questionnaire via smartphone|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| smartphone use level | evaluation of the interest of patient to use their smartphone in the purpose to follow their anticoagulant treatment | 15 days |
Insulin Resistance in Primary Hyperparathyroidism

Study Overview
=================
Brief Summary
-----------------
The aims of this study is to analyse if insulin resistance in primary hyperparathyroidism (pHPT) is normalised after parathyroid adenomectomy and if glucose tolerance test may be useful as a diagnostic tool by predicting potential improvement of insulin sensitivity after biochemical cure of pHPT.

Detailed Description
-----------------
To be conducted at the Karolinska University Hospital, Stockholm. Patients with fb-glucos >6.1 and HbA1c without medical treatment will be included after informed consent and randomised to parathyroidectomy (PTX) within three months or not. The groups will be examined 4 ±4 weeks before and 12±2 weeks after PTX, similar for the control group. The number of participants will be estimated by power calculations based on a pilot study including 20 patients. The test protocol includes glucose load with control of glucose and insulin, (0, 30, 60 and 120 min) together with measurement of markers of oxidative stress and inflammation.

Official Title
-----------------
Insulin Resistance in Primary Hyperparathyroidism, a Non-classical Manifestation

Conditions
-----------------
Hyperparathyroidism, Diabetes, Hypercalcemia

Intervention / Treatment
-----------------
* Procedure: parathyroidectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: primary hyperparathyroidism and fb-glukos>6,1 and/or HbA1c > 39 mmol/mol Exclusion Criteria: Treatment with insulin, sulfonylurea or metformin

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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: parathyroidectomy<br>change in insulin resistance | Procedure: parathyroidectomy<br>* surgical treatment of hyperparathyroidism<br>* Other names: parathyroid adenomectomy;|
| No Intervention: control<br>the study participant will be examined parallel with the active comparator | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| glucose tolerance test with estimation of insulin resistance | Homa IR | 3 months | 
| quality of life - self estimation protocol | EORTC QLQ-C30 | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| psychological wellbeing | POMS | 3 months | 
| anxiety, depression | HAD | 6 months | 
| cognition | MoCA-Test | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hyperparathyroidism, insulin resistance