linjc16/ctgov huggingface dataset:
Double-Blind, Four Week Trial Of [S,S]-Reboxetine And Atomoxetine In Adults With Attention Deficit Hyperactivity Disorder.

Study Overview
=================
Brief Summary
-----------------
This study will compare the safety and efficacy of [S,S]-reboxetine to atomoxetine in the treatment of adult patients with attention deficity-hyperactivity disorder.

Official Title
-----------------
Phase 2, Randomized, Double-Blind, Parallel-Group, Four Week, Efficacy And Safety Trial Of [S,S]-Reboxetine (PNU-165442g) And Atomoxetine In Adults With Attention Deficit Hyperactivity Disorder.

Conditions
-----------------
Attention Deficit Hyperactivity Disorder

Intervention / Treatment
-----------------
* Drug: Atomoxetine
* Drug: PNU-165442G; [S,S]-reboxetine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Attention Deficit Hyperactivity Disorder according to DSM-IV criteria. Score of 24 or higher on the Adult ADHD Investigator Symptom Rating Scale Score of 4 or higher on the Clinician Global Impression - Severity scale Exclusion Criteria: Significant comorbid psychiatric diagnoses Significant risk of suicidal or violent behavior

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: Arm A<br> | Drug: PNU-165442G; [S,S]-reboxetine<br> <br> |
| Active Comparator: Arm B<br> | Drug: Atomoxetine<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adult ADHD Investigator Symptom Rating Scale - Total Score |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adult ADHD Investigator Symptom Rating Scale - Inattention Subscale Score |  | 4 weeks | 
| Adult ADHD Investigator Symptom Rating Scale - Hyperactivity/Impulsivity Subscale Score |  | 4 weeks |
Google Trends of Global Surgery

Study Overview
=================
Brief Summary
-----------------
Introduction Global surgery is a growing movement worldwide, but its expansion has not been quantified. Google Search is the most popular search engine worldwide, and Google Trends analyzes its queries to determine popularity trends. The investigators used Google Trends to analyze the regional and temporal popularity of global surgery (GS). Furthermore, the investigators compared GS with global health (GH) to understand if the two were correlated. Methods The investigators searched the terms global surgery and global health on Google Trends (Google Inc., CA, USA) from January 2004 to May 2021. The investigators identified time trends and compared the two search terms using SPSS v26 (IBM, WA, USA) to run summary descriptive analyses and Wilcoxon rank-sum tests.

Official Title
-----------------
Using Google Trends to Gauge the Popularity of Global Surgery Worldwide

Conditions
-----------------
Global Surgery, Global Health

Intervention / Treatment
-----------------
* Other: Investigation of Global Interest in Global Surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Data point from Google Trends concerning Global Surgery Data point from Google Trends concerning Global Health Data point from Google Trends between January 2004 and May 2021 Exclusion Criteria: Data point from Google Trends before January 2004 Data point from Google Trends after May 2021 Data point from Google Trends outside the scope of Global Surgery or Global Health
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Investigation of Global Interest in Global Surgery|The investigators searched the terms global surgery and global health on Google Trends (Google Inc., CA, USA) from January 2004 to May 2021. The investigators identified time trends and compared the two search terms using SPSS v26 (IBM, WA, USA) to run summary descriptive analyses and Wilcoxon rank-sum tests.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interest Levels | Level of interest in Global Surgery based on Google Trends | January 2004 to May 2021 |
A Study of the Natural History of Leukocyte Chemotactic Factor 2 Amyloidosis (ALECT2) Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to characterize the natural history of leukocyte chemotactic factor 2 amyloidotic (ALECT2) disease. In this observational study participants with ALECT2 disease will be enrolled. Participants, who have already reached end-stage renal disease (ESRD), will provide retrospective chart review data and biological specimens at baseline only. Other participants, in addition to retrospective chart review, will be followed prospectively.

Detailed Description
-----------------
Refer to www.studyALECT2.com

Official Title
-----------------
A Study of the Natural History of Leukocyte Chemotactic Factor 2 Amyloidosis (ALECT2) Disease

Conditions
-----------------
Amyloidosis, Leukocyte Chemotactic Factor 2 Amyloidosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females, age 18 years or older; Renal biopsy-proven diagnosis of ALECT2; For patients with kidney disease that could be due to ALECT2, a renal biopsy may be obtained to confirm ALECT2 diagnosis. Exclusion Criteria: - There are no exclusion criteria for this observational study.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ALECT2 Disease<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Estimated Glomerular Filtration Rate (eGFR) from Baseline Up to End of Study (Month 48) |  | Baseline (Day 1), Months 6, 12, 18, 24, 30, 36, 42 and 48 | 
| Time to End-Stage Renal Disease (ESRD) |  | From baseline to end of study (Month 48) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of Leukocyte Chemotactic Factor 2 (LECT2) Messenger Ribonucleic Acid (mRNA) in Blood |  | Baseline (Day 1), Months 6, 12, 18, 24, 30, 36, 42 and 48 | 
| Level of LECT2 mRNA in Urine |  | Baseline (Day 1), Months 12, 24, 36 and 48 | 
| Level of LECT2 Protein in Blood |  | Baseline (Day 1), Months 6, 12, 18, 24, 30, 36, 42 and 48 | 
| Level of LECT2 Protein in Urine |  | Baseline (Day 1), Months 12, 24, 36 and 48 | 
| Percentage of Participants With Proteinuria |  | Baseline (Day 1), Months 12, 24, 36 and 48 |
Survey and Cognitive Behavior Therapy for Chronic Fatigue Syndrome/Myalgic Encephalomyelitis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to analyze income variables in Chronic Fatigue Syndrome/Myalgic Encephalomyelitis, and to analyze the effect of short vs. long Cognitive Behaviour Therapy.

Official Title
-----------------
A RCT Study on the Effect of Short and Long Cognitive Behaviour Therapy (CBT) in CFS/ME Patients

Conditions
-----------------
Chronic Fatigue Syndrome, Myalgic Encephalomyelitis, Fatigue, Pain

Intervention / Treatment
-----------------
* Behavioral: CBT
* Behavioral: CBT
* Behavioral: Control group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients referred to St.Olav Hospital, Trondheim fulfil the FUKUDA criteria for CFS/ME. Exclusion Criteria: Pregnant patients

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 62 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: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 8 weeks CBT<br> | Behavioral: CBT<br>* Individual Cognitive Behavior Therapy during 8 weeks<br>|
| Active Comparator: Control group<br> | Behavioral: Control group<br>* Waiting 16 weeks and receiving 8 weeks individual CBT after waiting period.<br>|
| Experimental: 16 weeks CBT<br> | Behavioral: CBT<br>* Individual Cognitive Behavior Therapy during 16 weeks<br>* Other names: Grades excercise therapy;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mental and physical function | Mental and physical function, measured by SF 36. Success criteria are measured by >10 point improvement of mental and/ or physical function. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CBT, Fukuda criteria, Mental functioning, Physical functioning
Pharmacokinetics and Safety Between DWJ1421 and DWC201903 in Healthy Male Volunteers

Study Overview
=================
Brief Summary
-----------------
This is a randomized, open label, single dose, crossover study to compare the pharmacokinetics and safety between DWJ1421 and DWC201903 in healthy male volunteers.

Official Title
-----------------
A Randomized, Open Label, Single Dose, Crossover Study to Compare the Pharmacokinetics and Safety Between DWJ1421 and DWC201903 in Healthy Male Volunteers

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

Intervention / Treatment
-----------------
* Drug: DWJ1421
* Drug: DWC201903


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Between 19 aged and 45 aged in healthy male adult Body weight more than 50kg Body Mass Index more than 18.0 and under 27.0 Exclusion Criteria: Those who have clinical significant liver, kidney, digestive system, respiratory, endocrine, nervous system, hematology and oncology, cardiovascular, urinary diseae or past history Those who have a gastrointestinal disease history that can effect drug absorption or surgery Those who have hypersensitivity reaction or clinically significant hypersensitivity reaction in the history of Investigational product

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A (RT)<br>Period 1 : Reference drug (DWC201903) Period 2 : Test durg(DWJ1421) | Drug: DWC201903<br>* 1 tablet administered in fasting condition<br>|
| Experimental: B (TR)<br>Period 1 : Test durg(DWJ1421) Period 2 : Reference drug (DWC201903) | Drug: DWJ1421<br>* 1 tablet administered in fasting condition<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax | Maximum concentration of DWJ1421 | 0, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14h | 
| AUClast | Area under the drug concentration-time curve | 0, 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 14h |
Study of Conscious Behavior Under Low-frequency Deep Brain Stimulation in Chronic and Severe Post-coma Disorders of Consciousness

Study Overview
=================
Brief Summary
-----------------
Chronic post-coma consciousness impairment is a severe handicap. Preliminary studies suggest that deep brain stimulation of the thalamic-tegmental reticular system could improve consciousness disorders, and facilitate the emergence of conscious behavior. The aim of this protocol is to study the effects of deep brain stimulation on conscious behavior, using a patient-based anatomic mapping for stereotactic surgery, and the Coma Recovery Scale-Revised (CRS-R) as clinical assessment criterion.

Detailed Description
-----------------
Total length of inclusion for a patient: 10 months (2 months before electrodes implantation, 8 months after).

Official Title
-----------------
Study of Conscious Behavior Under Low-frequency Deep Brain Stimulation in Chronic and Severe Post-coma Disorders of Consciousness

Conditions
-----------------
Chronic and Severe Post-coma Disorders of Consciousness (Permanent Vegetative State, Minimally Conscious State)

Intervention / Treatment
-----------------
* Other: Implantable neurostimulation system


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients stably in Vegetative state or Minimally conscious state, since at least 6 months after cerebrovascular accident and 1 year after traumatic brain injury. Exclusion Criteria: Cerebral death, Locked-In Syndrome, blindness, deafness

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: Treatment
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: deep brain stimulation<br> | Other: Implantable neurostimulation system<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CRS-R scores (Coma Recovery Scale-Revised) |  | after 2 months and after 7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| signs of awakening at night |  | during the 10 months of the study | 
| zerit burden interview |  | at 1 month and at 10 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Deep Brain Stimulation (DBS), Post-coma, Consciousness, Vegetative state, Minimally conscious state
Chemotherapy With or Without Radiosurgery for Asymptomatic Oligo Brain Metastasis

Study Overview
=================
Brief Summary
-----------------
The need of radiosurgery is controversial for asymptomatic oligo brain metastasis for non small cell lung cancer (NSCLC). Therefore, the investigators do a randomized study comparing overall survival between two groups with or without radiosurgery for asymptomatic oligo brain metastasis before palliative chemotherapy for NSCLC.

Official Title
-----------------
Randomized Phase III Trial of Stereotactic Radiosurgery (SRS) Versus Observation for Patients With Asymptomatic Cerebral Oligo-metastases in Non-small Cell Lung Cancer (NSCLC)

Conditions
-----------------
Nonsmall Cell Lung Cancer

Intervention / Treatment
-----------------
* Radiation: Radiosurgery
* Radiation: Observation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed non-small cell lung cancer with synchronous brain metastases One to 4 intraparenchymal brain metastases by contrast-enhanced MRI, meeting the following criteria: Well circumscribed tumor(s) with brain edema Grade 0-1 Maximum diameter ≤ 3.0 cm No prior surgical treatment or RT for brain metastases No leptomeningeal metastases by MRI or cerebrospinal fluid evaluation Patients without any symptoms or signs from brain metastases (RTOG neurologic functions status of 0) Age, 18 and over ECOG performance status 0-1 Written informed consent Exclusion Criteria: severe co-morbid illness and/or active infections pregnant or lactating women RTOG neurologic function status of 1 4 Uncontrollable extracranial metastases

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Radiosurgery arm<br>Radiosurgery before palliative chemotherapy | Radiation: Radiosurgery<br>* Gamma knife surgery for asymptomatic oligo-metastasis to brain from NSCLC<br>|
| No Intervention: Observation arm<br>No radiotherapy or local treatment until specific symptoms or sign developed | Radiation: Observation<br>* No local treatment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall survival |  | 1 year after the enrollment of the last patient | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to CNS progression |  | 1 year after the enrollment of the last patient | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asymptomatic brain metastasis, NSCLC, GKS
Dexmedetomidine Premedication in Children

Study Overview
=================
Brief Summary
-----------------
The aim of this retrospective study was to detect the effectiveness of 1µg/kg oral dexmedetomidine premedication on preoperative cooperation and emergence delirium of the the young children underwent complete dental treatment.

Detailed Description
-----------------
One Hundred children between the ages 2-6 years of ASA I status underwent full mouth dental rehabilitation were enrolled in the study. Group Dex (n=50) received 1µg/kg dexmedetomidine in apple juice and Group control (n=50) received apple juice only. Patients' Ramsey Sedation Scale (RSS), The Parental Seperation Anxiety Scale (PSAS), Mask Acceptance Scale (MAS) and Post anesthesia emergence delirium scale (PAEDS) and hemodynamic parameters were noted from their patient file. Premedication period was 45 minutes and measurements of RSS and hemodynamic parameters were recorded in baseline and every 15 minutes until the patients were transferred to the operating room. The data were analysed using the Kruskal-Wallis test, two sample t- tests, chi-square tests and ANOVA.

Official Title
-----------------
The Effect of Oral Dexmedetomidine Premedication On Preoperative Cooperation and Emergence Delirium In Children Undergoing Dental Treatment

Conditions
-----------------
Premedication

Intervention / Treatment
-----------------
* Drug: Dexmedetomidine
* Other: apple juice


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The inclusion criteria is age between 2 to 6 years and American Society og Anesthesiology (ASA) grade 1. Exclusion Criteria: The exclusion criteria included congenital disease, DEX, propofol allergy, asthma, mental retardation and those children parents refuse to participate study.

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


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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Retrospective study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dexmedetomidine<br>Group administered 1µg/kg dexmedetomidine oral | Drug: Dexmedetomidine<br>* 1µg/kg dexmedetomidine oral<br>* Other names: Precedex;|
| Other: Control<br>Apple juice | Other: apple juice<br>* apple juice<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ramsey Sedation Score | Sedation level | 45 minutes after premedication | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parental Separation Anxiety Score | Separation anxiety | preoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dexmedetomidine, child, premedication, emergence delirium, dental treatment
Robotic Rehabilitation Treatment of Stroke Patients

Study Overview
=================
Brief Summary
-----------------
Storke results in severe deterioration in quality of life and exercise. Severe disorders need to be treated as soon as possible and they need to be rehabilitated quickly in order for motor functions to develop properly. In the acute / subacute phase, patients are given robotic treatment. In addition to the study of mtoros functions, the study of gait and codination is the primary result. Patients treated with soft exoskeleton receive 15 treatments and movement testing is performed continuously. Members of the control group receive standard rehabilitation therapy. After 3 weeks, both groups will participate in a control study and then in a repeat control study at week 6. Our main goal is to compare the results and determine the efficiency of the robotic device.

Official Title
-----------------
Robotic Rehabilitation Treatment of Stroke Patients

Conditions
-----------------
Stroke, Acute, Stroke, Ischemic

Intervention / Treatment
-----------------
* Other: Neurorehabilitation
* Other: Physiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: post stroke 6MWT : 120> minimum after stroke 3 days Exclusion Criteria: Sever heart problem sever demeanor alcoholism drug problems

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 80 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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Robotic<br> | Other: Neurorehabilitation<br>* Neurorehabilitation with soft exsoskeleton robotic 3-week-long<br>* Other names: Rob group;|
| Active Comparator: Controll<br> | Other: Physiotherapy<br>* Physiotherapy 3-week-long<br>* Other names: Controll groum;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Qualiti of life measured by Barthel index | quetionnaire | 3 weeks | 
| gait/functional test | 6 minute walk test (m) | 3 weeks | 
| gait/functional test | 10 m walk test (m/s) | 3 weeks | 
| balance test | Berg balance test | 3 weeks | 
| postural control test | posturography | 3 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
balance, soft exoskeleton, walk, robotic