linjc16/ctgov huggingface dataset:
The Effects of Marijuana on Orientation and Motor Coordination and Brain Metabolism in Regular Smokers of Marijuana

Study Overview
=================
Brief Summary
-----------------
This study investigates the effects of 17mg and 13mg Delta THC on orientation and motor coordination and brain metabolic activity in regular users of marijuana. Subjects were tested twice, after smoking cigarettes with marijuana and after smoking cigarettes without marijuana.On both occasions they performed on a virtual reality maze task. They were afterwards scanned in Positron Emission Tomography (PET) with Fluoro-deoxy-glucose (FDG).

Detailed Description
-----------------
This study investigates the effects of 17mg and 13mg Delta THC on orientation and motor coordination and brain metabolic activity in regular users of marijuana. Subjects were tested twice, after smoking cigarettes with marijuana and after smoking cigarettes without marijuana. On both occasions they performed on a virtual reality maze task. They were afterwards scanned in Positron Emission Tomography (PET) with Fluoro-deoxy-glucose (FDG). 12 subjects were tested so far on both conditions.

Official Title
-----------------
The Effects of Marijuana on Orientation and Motor Coordination and Brain Metabolism in Regular Smokers of Marijuana.

Conditions
-----------------
Marijuana Dependence

Intervention / Treatment
-----------------
* Drug: Tetra Hydro Cannabinol (THC)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Marijuana dependence Age 20-65 Male and female Exclusion Criteria: Pregnant women Dependence on other substances Psychiatric diagnosis apart from marijuana dependence Neurological disorder Young persons

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: A<br>Low nicotine cigarettes without THC | Drug: Tetra Hydro Cannabinol (THC)<br>* Oral THC 13mg and 17mg smoked in low nicotine cigarettes<br>* Other names: Marijuana, cannabis;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brain metabolic activity (FDG) |  | 30-40 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reaction time (RTs) and errors in performance |  | 40 minutes | 
| Subjective ratings on visual analog scale |  | 10 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Marijuana, FDG, PET, maze, THC, motor coordination.
Efficacy and Safety of A-prexa Compared to Zyprexa in Patients With Schizophrenia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and safety of A-prexa compared to Zyprexa in patients with schizophrenia, schizophreniform disorder and schizoaffective disorder.

Official Title
-----------------
A Multi-center, Randomized, Double Blind, Parallel, PhaseⅣ Trial to Evaluate the Efficacy and Safety of A-prexa Compared to Zyprexa in Patients With Schizophrenia, Schizophreniform Disorder and Schizoaffective Disorder

Conditions
-----------------
Schizophrenia, Schizophreniform Disorder, Schizoaffective Disorder

Intervention / Treatment
-----------------
* Drug: A-prexa
* Drug: Zyprexa


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 20 years to 65 years Schizophrenia patient with an acute exacerbation Understand the requirement of the study and voluntarily consent to participate in the study Exclusion Criteria: Patients who have another psychiatric disorders Patients who have unstable medical conditions Patients who have clinically important abnormalities of liver function test (>2.5 fold of upper normal limit), ECG and vital sign at screening visit Uncontrolled diabetic patients (plasma glucose level is more than 126 mg/dl in fasting condition) Patients who have a history of an allergic reaction to olanzapine Patient who have no clinical response to take two or more different atypical anti-psychotics for more than 4 weeks. Patient who take clozapine within 12 weeks before screening visit

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 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: A-prexa<br>A-prexa 5, 10mg | Drug: Zyprexa<br>* Zyprexa 5-20 mg for 6 weeks<br>|
| Active Comparator: Zyprexa<br>Zyprexa 5, 10mg | Drug: A-prexa<br>* A-prexa 5-20 mg for 6 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline at 6 week in total PANSS score |  | 6 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline at 1, 2, 4 and 6 week in total PANSS score. |  | 6 week | 
| Responder to be decreased of 30% or more in PANSS total score from baseline at 6 week |  | 6 week | 
| Change from baseline at 6 week in total CGI-S score |  | 6 week | 
| Responder rate in CGI-I score of 'very much improved', 'much improved' and 'minimally improved' |  | 6 week |
A Single-Dose Study in Normal Volunteers to Assess the Safety, Tolerability and Pharmacokinetics of STX107

Study Overview
=================
Brief Summary
-----------------
The objectives of this study are to determine the safety and tolerability of single oral doses of STX107 and to determine basic pharmacokinetic (PK) parameters following single oral doses of STX107 when administered via an oral suspension

Official Title
-----------------
A Single-Dose, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study in Healthy, Normal Volunteers to Assess the Safety, Tolerability and Pharmacokinetics of STX107

Conditions
-----------------
Fragile X Syndrome

Intervention / Treatment
-----------------
* Drug: STX107


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Normal, healthy males 18-50 years old, inclusive. Able to comprehend and willing to sign an Informed Consent Form (ICF). Exclusion Criteria: Significant history or clinical manifestation of any significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder (as determined by the Investigator).

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

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

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: STX107<br>* Single dose of an oral suspension<br>|
| Active Comparator: STX107<br> | Drug: STX107<br>* Single dose of an oral suspension<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  | During the course of the study and for 14 days after completing the study |
Efficacy of TEAS On Prevention of Propofol Injection Pain in Children

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the efficacy of transcutaneous electrical acupoint stimulation for the prevention of propofol injection pain in children.

Detailed Description
-----------------
Pain from the injection of propofol is a common side effect during anesthetic practice. Various methods have been used to reduce this pain. This prospective, randomized study was designed to determine the efficacy of transcutaneous electrical acupuncture point stimulation in reducing propofol injection pain in children.

Official Title
-----------------
Efficacy of Transcutaneous Electrical Acupuncture Point Stimulation (TEAS) for the Prevention of Propofol Injection Pain in Children

Conditions
-----------------
Injection Site

Intervention / Treatment
-----------------
* Device: TEAS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I-II and aged 6-13 years patents who will undergo elective surgery under general anesthesia Exclusion Criteria: patients with propofol allergy patients who have renal, hepatic, cardiac, neurological, psychiatric disease Cardiac and cranial surgery Pacemaker, Emergency surgery and patients requiring rapid serial induction

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 13 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: GROUP TEAS<br>Patients will receive TEAS bilaterally at two acupoints: Hegu (L14) and Neiguan (PC6). | Device: TEAS<br>* Transcutaneous electrical acupuncture stimulation<br>|
| Placebo Comparator: Control Sham Group<br>Patients in the sham group will be undergoing electrode attachment on the target acupoints without electronic stimulation. | Device: TEAS<br>* Transcutaneous electrical acupuncture stimulation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain with propofol injection | pain will be assessed using a four point behavioral scale: 1= no pain (no reaction); 2= mild pain (grimace); 3= moderate pain (grimace+cry); 4= severe pain (cry+withdrawal) | 5 minutes |
Does Oral Magnesium Substitution Relieve Pregnancy Induced Leg Cramps ?

Study Overview
=================
Brief Summary
-----------------
This is a trial of treatment with tablets containing magnesium for leg cramps in pregnancy.

Detailed Description
-----------------
Healthy pregnant women between 18 and 36 weeks of pregnancy suffering from leg cramps at least twice a week were treated with magnesium tablets or placebo for two weeks, 120 mg x 3 daily.

Official Title
-----------------
Does Oral Magnesium Substitution Relieve Magnesium Induced Leg Cramps ?

Conditions
-----------------
Cramps

Intervention / Treatment
-----------------
* Drug: Nycoplus Magnesium (120 mg x 3 daily for 2 weeks)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women with recurrent leg cramps (at least twice a week). No disease according to helath certificate. Written participation consent must be signed. Linguistic ability demanded: Norwegian as the first language. Gestation length more than 17 weeks, less than 36 weeks. Exclusion Criteria: Twin pregnancy. Oedema. Pre-eclampsia. Magnesium supplementation beyond the trial treatment.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 38 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Magnesium tablet suplementation (1)<br>Nycoplus Magnesium (120 mg x 3 daily for 2 weeks) | Drug: Nycoplus Magnesium (120 mg x 3 daily for 2 weeks)<br>* 120 mg x 3 or placebo<br>* Other names: Placebo tablets;|
| Placebo Comparator: Placebo tablet suplementation (2)<br>Placebo (3 times daily for 2 weeks) | Drug: Nycoplus Magnesium (120 mg x 3 daily for 2 weeks)<br>* 120 mg x 3 or placebo<br>* Other names: Placebo tablets;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity and frequency |  | end of study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pregnancy, Magnesium, Leg Pain
Incidence and Prognostic Value of DELIRIUM in Patients With Acute CORonary synDrome: an observatIonal Study

Study Overview
=================
Brief Summary
-----------------
to evaluate the incidence of delirium in patients with acute coronary syndrome and its correlation with adverse events

Official Title
-----------------
Incidence and Prognostic Value of DELIRIUM in Patients With Acute CORonary synDrome: an observatIonal Study by the DELIRIUM-CORDIS Investigators.

Conditions
-----------------
Delirium, Acute Coronary Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: acute coronary syndrome patients undergone coronary revascularization or referred to conservative strategy age ≥ 70 years diagnosis of delirium by the Confusion Assessment Method in the ICU (CAM-ICU) scale Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 70 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 |
| --- | --- |
| acute coronary syndrome and delirium<br>patients with acute coronary syndrome and delirium | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| in-hospital adverse events incidence |  | until discharge (4-7 days from admission) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 12-month adverse events incidence |  | 12 months |
System Accuracy of 12 Bloog Glucose Monitoring Systems

Study Overview
=================
Brief Summary
-----------------
The system accuracy of 12 blood glucose monitoring systems is to be evaluated randomly in accordance with DIN EN ISO 15197:2015 in the course of the year 2022.

Official Title
-----------------
Evaluation of the System Accuracy of 12 Blood Glucose Monitoring Systems According to ISO 15197:2015

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Diagnostic Test: blood glucose measurement: BGM
* Diagnostic Test: blood glucose measurement: reference method


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female, with clinical indication for blood glucose measurement Signed informed consent form Minimum age of 18 years Subjects are legally competent and capable to understand character, meaning and consequences of the study. Exclusion Criteria: Pregnancy or lactation period Severe acute disease (at the study physician's discretion) Severe chronic disease with inherent risk of aggravation by the procedure (at the study physician's discretion) Current constitution that compromises the subject's capability to participate in the study (at the study physician's discretion) A current constitution that does not allow participating in the study (e.g. hematocrit out of BGM specifications, medication known to influence blood glucose measurements; see Appendix A of ISO 15197) Being unable to give informed consent < 18 years Legally incompetent

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subject BGMS measurement<br>Blood glucose measurement using BGMS | Diagnostic Test: blood glucose measurement: BGM<br>* measurement of blood glucose concentration using different BGM<br>Diagnostic Test: blood glucose measurement: reference method<br>* measurement of blood glucose concentration using reference Method<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement performance: System accuracy | Assessment of the analytical measurement performance of blood glucose monitoring systems based on procedures defined in DIN EN ISO 15197 using results obtained from fingertip blood glucose measurements compared to a reference equipment | 4-6 hours |
Validation IMU and EMG Algorithms in Stroke Patients

Study Overview
=================
Brief Summary
-----------------
The objective is to validate the algorithms for movement analysis that were developed previously in healthy participants, in a small study with stroke patients. Stroke subjects will be measured while performing tasks like walking, sitting and standing while wearing light-weight inertial measurements units (IMUs) incorporating 3D accelerometers, 3D gyroscopes and surface electromyography. During the measurements subjects will be recorded on video that serves as ground truth when validating the implemented algorithms for movement analysis. A face blurring program will be used for all video footage.

Detailed Description
-----------------
Subjects will perform the following tasks: 30 sec stationary sitting/standing/lying; 10m walk test; L-test; 8-figure walking test; daily life task; stepping over small obstacles; walk in the corridor. During the measurments IMU will be placed at: sternum; sacrum; bilateral wrists; bilateral shanks; bilateral upper legs; both feet. Surface EMG of bilateral rectus femoris; vastus lateralis; medial gastrocnemius and soleus will be measured.

Official Title
-----------------
Validation IMU and EMG Algorithms in Stroke Patients

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Other: algorithm validation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: min 18 yrs of age; history of previous stroke; unilateral affected;able to walk without supervision (FAC-score min 4);able to perform activities of daily living without assistance (self-reported); written informed consent. Exclusion Criteria: subjects with neurological or motor disorders that could interfere with the measurements (other than stroke) or severe deficits in communication, memory and understanding.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Algorithm validation<br>all subjects will be measured with inertial measurement units while performing tasks like walking, standing and sitting. | Other: algorithm validation<br>* stroke subjects are measured to validate algorithms previously developed after including healthy subjects<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inertial measurement unit data | Activity data of the sensors attached to various body parts | 1-2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| surface EMG-data | rectus femoris/vastus lateralis/gastrocnemius/soleus data | 1-2 hours |
Chronic Complaints After Small Umbilical Hernia Repair

Study Overview
=================
Brief Summary
-----------------
There are only little data on the risk of chronic complaints (pain and discomfort) following open non-mesh sutured repairs of small umbilical or epigastric hernias. Our primary and secondary endpoints were long-term pain and discomfort at rest, respectively and thirdly recurrence. The setup was a retrospective two-centre study including patients ≥18 years undergoing primary elective open non-mesh sutured umbilical or epigastric hernia repairs. The survey included questions on suspicion of recurrence, reoperation for recurrence (if yes patients were examined by a consultant in patients home), pain, discomfort, work, and leisure activities. We analysed 295 consecutive patients through a non-validated structured questionnaire.

Official Title
-----------------
High Incidence of Chronic Complaints and Recurrence 5 Years After Simple Sutured Umbilical Hernia Repair

Conditions
-----------------
Chronic Pain, Ventral Hernia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: primary elective open non-mesh sutured umbilical or epigastric hernia repair Exclusion Criteria: mesh repair, acute repair, repair secondary to other operation, recurrent hernia repair, combined hernia repair, laparoscopic hernie repair, trocar hernia repair, incompensated liver cirrhosis, age < 18 years, pregnancy

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 |
| --- | --- |
| retrospective surgical patients<br>consecutive elective umbilical hernia repair patients during two years from two hospitals,- retrospective id with prospective follow up | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain at rest at the hernia repair site | a verbal rating scale for pain is used (none, little, moderate or severe | chronic complaints 5 years after hernia repair | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| discomfort at rest at the hernia site | a verbal rating scale for pain is used (none, little, moderate or severea | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pain, hernia, chronic, discomfort, retrospective