linjc16/ctgov huggingface dataset:
High Order Spectral Analysis of Local Field Potential Data on a Subgroup of Parkinson's Disease Patients Who Are Carriers of Mutations in the Glucocerebrosidase (GBA) Gene Undergoing DBS Electrode Placement

Study Overview
=================
Brief Summary
-----------------
The aim is to study a specific group of PD patients, carriers of mutations in the glucocerebrosidase (GBA) gene, which is the most common genetic risk factor for PD and is a harbinger of aggressive cognitive and motor decline. Approximately 12-17% of PD patients undergoing DBS are GBA mutation carriers. GBA mutation carriers with PD have a specific phenotype characterized by more significant motor dysfunction and reduced short-term visual memory function compared with their non-GBA counterparts. Thus as GBA mutation carriers have a signature phenotype, the investigators hypothesize that these GBA mutation carriers have a unique signature of oscillatory activity that can be distinguished from non-mutation carriers during motor activation and during cognitive tasks. Identification of this signature will provide critical information that is required to: 1) understand the underlying neurophysiological mechanisms responsible for the aggressive disease course of GBA associated PD, and 2) further develop customized adaptive DBS systems.

Official Title
-----------------
High Order Spectral Analysis of Local Field Potential Data on a Subgroup of Parkinson's Disease Patients Who Are Carriers of Mutations in the Glucocerebrosidase (GBA) Gene Undergoing DBS Electrode Placement

Conditions
-----------------
Parkinson Disease

Intervention / Treatment
-----------------
* Other: collection of LFPs


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: undergoing bilateral STN-DBS diagnosis of Parkinson's disease Exclusion Criteria: no Parkinson's disease

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 80 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 |
| --- | --- |
| GBA mutation carriers with PD undergoing STN-DBS<br> | Other: collection of LFPs<br>* collection of local field potentials (LFPs) at rest and during hand opening and closing<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in beta symmetry | LFP | 1 day |
Probiotics and Infections in Children Attending Day Care Centres

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effect of regular consumption of probiotic milk in preventing illnesses in Finnish children attending day care centres, and possible cost-benefits that could be associated with fewer illnesses.

Conditions
-----------------
Respiratory Tract Infections, Gastrointestinal Diseases

Intervention / Treatment
-----------------
* Dietary Supplement: Probiotic
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 2 to 6 years in the beginning of the intervention Attendance at a day care centre participating in the study (5 days a week) Exclusion Criteria: Milk allergy or lactose intolerance Congenital heart diseases that requires regular medication Malign diseases Cytostatic treatment Use of biological rheumatic medication Continuous microbial medication Regular use of oral corticosteroids (inhalable accepted) Diabetes Simultaneous participation in other clinical trials

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 6 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Probiotic milk<br> | Dietary Supplement: Probiotic<br> <br> |
| Placebo Comparator: Standard milk<br> | Other: Placebo<br> <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
-----------------
Costs and Cost Analysis
Second-line Irinotecan and Capecitabine Versus Irinotecan for Gemcitabine and Cisplatin Refractory Biliary Tract Cancer

Study Overview
=================
Brief Summary
-----------------
This study is designed to investigate the effect of second-line irinotecan and capecitabine versus irinotecan alone for gemcitabine and cisplatin refractory advanced biliary tract cancer patients.

Official Title
-----------------
Effect of Second-line Irinotecan and Capecitabine Versus Irinotecan Alone in Advanced Biliary Tract Cancer Patients Progressed After First-line Gemcitabine and Cisplatin: A Randomized Controlled Study

Conditions
-----------------
Biliary Tract Neoplasms

Intervention / Treatment
-----------------
* Drug: Irinotecan
* Drug: Capecitabine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with histologically confirmed advanced biliary tract cancer who had experienced progression during first-line gemcitabine and cisplatin Age 18 years or older Measurable reference cancer site(s) confirmed with computed tomography (CT) or magnetic resonance imaging (MRI) Karnofsky performance status (KPS) of at least 70% Adequate renal function, adequate hepatic function, adequate bone marrow function Exclusion Criteria: The presence of any severe concomitant disease that could interrupt the planned treatment Intractable pain Hypersensitivity to study drugs Serious cardiovascular disease If female, pregnancy or breastfeeding

Ages Eligible for Study
-----------------
Minimum Age: 18 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Irinotecan and Capecitabine<br>irinotecan 180mg/m2 d1, capecitabine 1000mg/m2 bid d1-10, q2w | Drug: Irinotecan<br> <br> Drug: Capecitabine<br> <br> |
| Active Comparator: Irinotecan<br>irinotecan 180mg/m2 d1, q2w | Drug: Irinotecan<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival | PFS | within 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival | OS | within 1 year |
Establish a CT Images Database of Patients With Congenital Heart Disease

Study Overview
=================
Brief Summary
-----------------
Setup CT images database of congenital heart disease.

Detailed Description
-----------------
Setup CT images database of congenital heart disease.

Official Title
-----------------
Establish a CT Images Database of Patients With Congenital Heart Disease

Conditions
-----------------
Heart Diseases

Intervention / Treatment
-----------------
* Procedure: CT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - congenital heart disease Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 18 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: CT|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diagnostic accuracy |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| senstivity |  |  | 
| specificity |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CT, children, congenital
Factor Xa Inhibitor YM150 for the Prevention of Blood Clot Formation in Veins After Scheduled Hip Replacement (ONYX-2)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to find the best possible (optimal) dose (effect versus adverse events) of YM150 to prevent the risk of blood clot formation after scheduled hip replacement surgery.

Official Title
-----------------
Direct Factor Xa Inhibitor YM150 for Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Hip Replacement.---A Double Blind, Parallel, Dose-finding Study in Comparison With Open Label Enoxaparin

Conditions
-----------------
Thromboembolism

Intervention / Treatment
-----------------
* Drug: YM150


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Scheduled for elective primary hip replacement Age 18 years or over Written informed consent obtained Exclusion Criteria: Documented history or considered at increased risk of venous thromboembolism Subjects considered at increased risk of bleeding Surgery planned for contralateral hip at the same time or within 10 weeks after enrolment Concomitant use of anticoagulants/ antiplatelet agents

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: YM150|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of total venous thromboembolism (VTE) during hospitalization phase |  |  | 
| Incidence of clinically relevant bleeding during 7-10 days hospitalization treatment rated as Major |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proximal or distal deep vein thrombosis (DVT) during hospitalization phase |  |  | 
| Symptomatic VTE |  |  | 
| Rate of total VTE |  |  | 
| Death due to any cause during treatment |  |  | 
| Incidence of the bleeding types: |  |  | 
| Major or clinically relevant non-major bleeding, Major bleeding, |  |  | 
| Clinically relevant non-major bleeding, Minor bleeding |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hip replacement, Arthroplasty, Prevention, Thromboembolism, Treatment outcomes, Arthroplasty, replacement, hip
Study Of An Oral Tyrosine Kinase Inhibitor Of VEGFR-2 To Treat Small-Volume Ovarian, Peritoneal, Fallopian Tube Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether CP-547,632, an oral VEGFR-2 tyrosine kinase inhibitor is effective in the treatment of epithelial ovarian cancer, primary peritoneal serous cancer, or fallopian tube cancer for patients who have failed first line platinum-based therapy and have a persistent rising CA-125.

Official Title
-----------------
A Clinical Efficacy Study Of An Oral Tyrosine Kinase Inhibitor Of VEGFR-2 To Treat Recurrent Or Persistent Small-Volume Epithelial Ovarian Cancer, Primary Peritoneal Serous Cancer, Or Fallopian Tube Cancer

Conditions
-----------------
Ovarian Neoplasms, Peritoneal Neoplasms, Fallopian Tube Neoplasms

Intervention / Treatment
-----------------
* Drug: CP-547,632


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically proven epithelial ovarian cancer, primary peritoneal serous cancer, or fallopian tube cancerRecurrent or persistent elevated CA-125. For the purpose of this study, elevated CA-125 is defined as a value of â‰¥40 U/ml on two separate consecutive determinations made â‰¥1 week apart. CA-125 values obtained within 4 weeks of abdominal surgery should not be taken into account. No definitive disease or clinical and findings of small volume disease (&#163;1cm by spiral CT or &#163;2cm by conventional CT or clinical exam). Exclusion Criteria: No prior exposure to mouse antibodies or prior VEGF or VEGF receptor targeted treatment or other anti-angiogenic-directed, anti-cancer treatment including thalidomide. No prior consolidation therapy with cytotoxic agents for ovarian cancer. Continuation of hormone replacement therapy is permitted. No requirement for concomitant anticoagulant therapy. Administration of low dose anticoagulants for maintenance of central venous access is permitted.No chronic oral or intravenous steroid use.

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: CP-547,632|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| At the completion of Stage 1 of the study, it did not meet the objective response criteria to proceed to Stage 2 of the trial. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Given the outcome of the primary objective, analysis of secondary objectives were not formalized. |  |  |
Post Intensive Care Syndrome in COVID19 Patients

Study Overview
=================
Brief Summary
-----------------
This project is based in the implementation of a combined monitoring system (technological solutions and medical visits) in survivors of the critical illness due to the infectious disease by COVID-19. The main objective of the project is to characterize the Post-Intensive Care Syndrome (PICS) and detect early needs for specific treatment.

Official Title
-----------------
Characterization and Management of Post Intensive Care Syndrome in COVID19 Patients.

Conditions
-----------------
COVID19, Post Intensive Care Unit Syndrome

Intervention / Treatment
-----------------
* Diagnostic Test: Questionnaires


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients admitted to ICU for COVID 19 Exclusion Criteria: Mental health diagnosis previous to the COVID19 infection Acquired brain damage or neurological disease previous to the COVID19 infection

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Questionnaires|Participants will answer questionnaires in three areas: physical/functional, emotional status and cognitive status|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline Short Form 12 Health Survey (SF12) at 12 month | Health related quality of live scale. Values are directly transformed in T scores (mean=50; SD=10), with higher scores meaning better outcome. | Every month during a 12 months follow-up period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline Lawton & Brody Instrumental activities of daily living scale at 12 months | Measure of independent living skills. Values are from 0 to 8, with higher scores meaning better outcome. | Every month during a 12 months follow-up period | 
| Change from baseline Perceived Deficits Questionnaire (PDQ) at 12 months | Self-report measure of cognitive dysfunction. Values are from 0 to 22, with lower scores meaning better outcome. | Every month during a 12 months follow-up period | 
| Change from baseline Hospital Anxiety and Depression Scale (HADS) at 12 months | A self-assessment instrument for detecting states of depression and anxiety in the setting of an hospital medical outpatient. Values are from 0 to 42, with lower scores meaning better outcome. | Every month during a 12 months follow-up period | 
| Change from baseline Davidson Trauma Scale (DTS) at 12 months | Self-report measure of Post Traumatic Stress Disorder (PTSD) symptoms. | Every month during a 12 months follow-up period. Values are from 0 to 136, with lower scores meaning better outcome. |
Investigation of the Effect of 4 in 1 Block Application on Postoperative Analgesia in Knee Surgeries.

Study Overview
=================
Brief Summary
-----------------
to investigate the effects of ultrasonography-guided 4in1 block application on postoperative analgesia in patients undergoing knee surgery. After knee surgeries performed with spinal anesthesia, 4in1 block will be applied in one group and medical analgesics will be applied in the service in the other group.

Official Title
-----------------
Effects of Ultrasonography-guided 4in1 Block Application on Postoperative Analgesia in Patients Undergoing Knee Surgery

Conditions
-----------------
Visual Analogy Scala

Intervention / Treatment
-----------------
* Behavioral: visual analogy scala


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I-II 18-60 ages who were informed about the study and accepted, who underwent knee surgery Exclusion Criteria: ASA III-IV who are under general anesthesia who do not agree to participate in the study who are urgently operated

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 4in1<br>4in1 block will be applied in the operation room | Behavioral: visual analogy scala<br>* We will investigate the effect of 4in1 block by questioning the vas score of the patients, its effect on quadriceps strength, and additional analgesia needs for 24 hours.<br>|
| medical<br>medical analgesics will be applied in the service | Behavioral: visual analogy scala<br>* We will investigate the effect of 4in1 block by questioning the vas score of the patients, its effect on quadriceps strength, and additional analgesia needs for 24 hours.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visuel analogue scale | 0:No pain, 10:Very severe pain | 6 months |
Comparison of Different Fluence Settings for Yellow Subthreshold Laser Treatment in Diabetic Macular Edema

Study Overview
=================
Brief Summary
-----------------
To assess the safety and efficacy of two subthreshold parameters (5% and 15% duty cycle (DC)) compared to standard ETDRS (early treatment of diabetic retinopathy study) continuous wave (CW) laser

Detailed Description
-----------------
Test burn up to barely visible burn with micropulse laser, then reduce the power by 70% and perform laser with various DC (5%, 15%, cw) as per the group. Focal to Mas+ confluent burns to areas of diffuse leakage

Official Title
-----------------
To Assess the Safety and Efficacy of Two Subthreshold Parameters (5% and 15% Duty Cycle (DC)) Compared to Standard ETDRS (Early Treatment of Diabetic Retinopathy Study) Continuous Wave (CW) Laser

Conditions
-----------------
Diabetic Retinopathy

Intervention / Treatment
-----------------
* Procedure: Laser


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eyes with DME (center or non-center involving) with <350 microns central retinal thickness Exclusion Criteria: Subfoveal exudates, history of VR surgery, history of macular laser

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| two subthreshold parameters<br>5% and 15% duty cycle (DC) | Procedure: Laser<br> <br> |
| standard ETDRS<br>early treatment of diabetic retinopathy study | Procedure: Laser<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. Decrease in number of leaking Mas on FFA 2. Decrease in diffuse leakage on FFA | Comparing the number of leaking microaneuyrms baseline to 6 weeks with 3 types of lasers (two subthreshold parameters (5% and 15% duty cycle (DC)) compared to standard ETDRS continuous wave (CW) laser. | 3 months |
Unicirc Adolescent 12-15 Year Old Boys

Study Overview
=================
Brief Summary
-----------------
This is a field case series of Unicirc under topical anaesthetic among adolescent boys, aged 12 to 15 years.

Detailed Description
-----------------
Boys are healthy, without severe anatomic abnormalities complicating circumcision. Boys with moderate phimosis and tight frenulum were included. Informed assent was obtained.

Official Title
-----------------
Field Study of Unicirc Circumcision in Adolescent Boys, Aged 12 to 15 Years.

Conditions
-----------------
Circumcision, Male

Intervention / Treatment
-----------------
* Device: Unicirc circumcision


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy boys desiring circumcision Exclusion Criteria: current illness bleeding disorder reaction to local anaesthetic infection any penile abnormality potentially complicating circumcision

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 15 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Unicirc circumcision<br>Unicirc circumcision under topical anaesthetic, wound sealing with cyanoacrylate tissue adhesive | Device: Unicirc circumcision<br>* Unicirc circumcision under topical (EMLA) anaesthesia, wound sealing with cyanoacrylate tissue adhesive<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative Duration | Duration from placement of instrument to dressing | Intraoperative, 10-15 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative Pain | Intraoperative pain, measured on a standard 10 point pain scale (0=no pain, 5=moderate pain, 10 severe pain) using a pain face diagram. | Time of surgery, approximately 10-15 minutes | 
| Healed at 4 Weeks | Number of participants that are fully healed (epithelialized, no superficial ulcerations) at 4 weeks. | At the 4-week followup visit |