linjc16/ctgov huggingface dataset:
Clinically Relevant Asymmetry of Bispectral Index

Study Overview
=================
Brief Summary
-----------------
BIS for monitoring depth of anesthesia is usually obtained unilaterally. Obtaining BIS bilaterally revealed side differences in previous studies. This study investigates the incidence of clinically relevant side differences of BIS during maintenance and emergence from anesthesia for ENT surgery in both adults and children.

Detailed Description
-----------------
BIS was measured bilaterally in 42 adults and 46 children during ENT surgery under general anesthesia using two BIS-Monitors. Side differences of more than 10% were defined as BIS asymmetries. An increase of BIS of more than 10% from the value at the time of finishing anesthesia administration on only one side followed by movement after stimulation was defined as clinically relevant.

Official Title
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Clinically Relevant Asymmetry of Bispectral Index During Anesthesia for ENT Surgery in Adults and Children

Conditions
-----------------
Reaction; Anesthesia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:Children and adults during anesthesia for ENT surgery - Exclusion Criteria:Neurologic or psychiatric disease -
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Children<br>Children | |
| Adults<br>Adults | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Movement reaction to external stimulation during emergence from anesthesia | After surgery, administration of propofol and remifentanil was stopped and the measurement of BIS was continued. BIS was noted every minute and on each occasion BIS exceeded 10% of the value at stopping the application of anesthetics on one or both sides. If such a 10% increase was observed, arousal and movement after external stimulation was examined by suction of the mouth. BIS asymmetry on only one side followed by movement reaction to external stimulation within a 60 seconds period was defined as clinically relevant. | 30 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bispectral Index, Anesthesia, Asymmetry
Assessment of DOT Spectacles in Chinese Children

Study Overview
=================
Brief Summary
-----------------
This is a randomized, controlled, evaluator-blinded, multicenter, two-arm parallel group clinical trial of 12-months duration to evaluate the continued safety and efficacy of Diffusion Optics Technology (DOT) spectacle lenses by comparing to single vision, impact-resistant spectacle lenses in reducing the progression of juvenile myopia in children of Chinese origin.

Official Title
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Clinical Assessment of DOT Spectacle Lenses in Chinese Children

Conditions
-----------------
Juvenile Myopia, Myopia

Intervention / Treatment
-----------------
* Device: Novel spectacle lens design
* Device: Spectacle lenses


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children 6-13 years of age SER error between -0.75D and -5.00D Willingness to wear study spectacles and participate in the trial for 12 months without contact lens wear Exclusion Criteria: Prior usage of atropine, multifocal contact lenses, or orthokeratology (ortho-K) Astigmatism worse than -1.50 DC (by manifest refraction) in either eye Anisometropia (SER manifest refraction) greater than 1.00 D

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SightGlass Vision Test Arm 1<br>Single vision, impact-resistant spectacle lenses | Device: Novel spectacle lens design<br>* Use of lenses may reduce the rate of progression of juvenile myopia<br>|
| Other: Test Arm 2<br>Single vision, impact-resistant spectacle lenses | Device: Spectacle lenses<br>* Use of lenses may reduce the rate of progression of juvenile myopia<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Axial length | Change in axial length from baseline | 12 months |
The Influence of Deep TMS on Cerebellar Signs in Patients With Machado Joseph Disease

Study Overview
=================
Brief Summary
-----------------
To test the effects of low frequency deep rTMS using the novel HCERMJD-coil on cerebellar deficits in patients with SCA3 and to establish its safety in this population. Investigator is anticipate that stimulation of the cerebellum with the novel HCERMJD-coil may induce significantly therapeutic effects in patients with SCA3 and will pave the way for establishing a novel and effective treatment for this disorder.

Official Title
-----------------
The Influence of Deep Repetitive Transcranial Magnetic Stimulation (TMS) on Cerebellar Signs in Patients With Spinocerebellar Ataxia Type 3 (SCA3 - Machado Joseph Disease)

Conditions
-----------------
Machado Joseph Disease (SCA3)

Intervention / Treatment
-----------------
* Device: Deep TMS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: SCA3 patients aged 20 - 80 years, with detectable clinical signs and confirmed genetic diagnosis. Exclusion Criteria: Patients who have concomitant epilepsy. History of seizure or heat convulsion. Patients on neuroleptics. Patients with dementia (MMSE<25) or any unstable medical disorder. History or current unstable hypertension. History of head injury or neurosurgical interventions. History of any metal in the head (outside the mouth). Known history of any metallic particles in the eye, implanted cardiac pacemaker, implanted neurostimulators, surgical clips (above the shoulder line) or any medical pumps. History of frequent or severe headaches. History of migraine. History of hearing loss. History of cochlear implants History of drug abuse or alcoholism. Pregnancy or not using a reliable method of birth control. Participation in current clinical study or clinical study within 30 days prior to this study.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Deep TMS | Device: Deep TMS<br>* 1Hz Stimulation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scale for the Assessment and Rating of Ataxia (SARA) |  | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Machado Joseph disease, Deep TMS, TMS, Transcranial Magnetic Stimulation, SCA3, Magnetic Stimulation, Brainsway
Drug-Drug Interaction Study With Rifampin

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine if the concomitant administration of rifampin with BMS-708163 will affect the Pharmacokinetics of BMS-708163 and to assess safety and tolerability of co-administration BMS-708163 and rifampin

Official Title
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A Study of the Effect of Concomitant Administration of Rifampin on the Pharmacokinetics of BMS-708163 in Healthy Subjects

Conditions
-----------------
Alzheimer Disease

Intervention / Treatment
-----------------
* Drug: BMS-708163
* Drug: Rifampin
* Drug: Rifampin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male and postmenopausal female subjects, 18-55 yrs old inclusive Exclusion Criteria: Women of childbearing potential Tuberculosis

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BMS-708163<br> | Drug: BMS-708163<br>* Capsule, Oral, 125 mg, Once daily, 1 day<br>|
| Other: Rifampin<br> | Drug: Rifampin<br>* Capsule, Oral, 600 mg, Once daily, 7 days<br>|
| Experimental: Rifampin + BMS-708163<br> | Drug: BMS-708163<br>* Capsule, Oral, 125 mg, Once daily, 1 day<br>Drug: Rifampin<br>* Capsule, Oral, 600 mg, Once daily, 6 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMS-708163 alone and with rifampin: BMS-708163 single dose PK parameters (Cmax, Tmax, T-HALF, AUC(0-T), AUC(INF), CLT/F and molar AUCmet/AUCparent ratios will be assessed without rifampin (Day 1) and with rifampin (Day 13) |  | Within 30 days after dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMS-708163 alone and with rifampin: Safety and tolerability (AE's, ECG, vital signs, safety labs) |  | Within 30 days after dose |
REPETITIVE TRANSCRANIAL MAGNETIC STIMULATION IN the Treatment of DEPRESSION

Study Overview
=================
Brief Summary
-----------------
Subjects received rTMS daily on 10 consecutive weekdays (five sessions per week), during 20 minutes per session.During the rTMS session, the coil was centered flat over the right parietal cortex. We follow the patient during 12 weeks after the 2 weeks of tms (follow-up period) to measure the depression with different rating scales. We hypothesized that rTMS has a positive effect in the treatment of depression

Official Title
-----------------
Right Parietal Inhibition With rTMS in the Treatment of Depression

Conditions
-----------------
Depression

Intervention / Treatment
-----------------
* Device: Transcranial magnetic stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: In and outpatients aged between 16 and 65 who met DSM-IV criteria for major depressive episode, and who had a score of 25 or higher on the 10-item Montgomery Asberg Depression Rating Scale (MADRS) were included Exclusion Criteria: A history of epilepsy and any other medical disorder that should preclude the administration of rTMS. Only SSRI's, Mirtazapine and Promethazine as psychotropic medication was accepted if the dosage of antidepressive medication had not been changed for 6 weeks, and if the dosage of Promethazine had not been changed for 2 weeks prior to inclusion. Antidepressive medication had to remain stable during the 14 weeks of the study. Furthermore: schizophrenic disorder, a piece if metal in the brain, pacemaker and left-handed patients.

Ages Eligible for Study
-----------------
Minimum Age: 16 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Transcranial magnetic stimulation|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the depression (and so the effect of the treatment)we use the 10-item Montgomery Asberg Depression Rating Scale (MADRS)and we measure before tms (T=0), at week 1 (T=1), at week 2 (T=2), at week 4 (T=3), at week 8 (T=4), at week 14 (T=5) |  |  | 
| Besides the MADRS we use the BDI (Beck depression Inventory, the Hamillton deppression and anxiety scale) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| -Changes in anxiety |  |  | 
| -.Autonomic changes |  |  | 
| -.changes in the emotioneal attention, in the emotional memory en in de emotional recognition. |  |  | 
| -.Biochemical changes |  |  | 
| -.Changes in the EEG |  |  | 
| >> measured before tms and after (at T=0 and T=2) |  |  |
Diagnostic Accuracy of ShuntCheck Compared to Radionuclide Shunt: Patency in Patients With Normal Pressure Hydrocephalus

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the diagnostic accuracy of ShuntCheck compared with radionuclide shunt patency testing (SPS) to detect CSF shunt flow of NPH patients with suspected shunt obstruction.

Detailed Description
-----------------
The purpose of this study is to assess the diagnostic accuracy of ShuntCheck compared with radionuclide shunt patency testing (SPS) to detect CSF shunt flow of NPH patients with suspected shunt obstruction.

Official Title
-----------------
Diagnostic Accuracy of ShuntCheck Compared With Radionuclide Shunt Patency Test to Detect Shunt Flow Obstruction in Patients With Normal Pressure Hydrocephalus - A Cross-sectional Analytic Study

Conditions
-----------------
Hydrocephalus, Normal Pressure

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men or women 40 yo or older and have a VP shunt placed for NPH and are suspected of shunt obstruction. Capable of providing valid signed informed consent, or has a legal guardian, health care agent, or surrogate decision maker (according to local statutes, and collectively referred to as surrogates in this protocol) capable of providing valid, signed informed consent Exclusion Criteria: Presence of multiple shunts, or presence of more than one distal shunt catheter (regardless of function) crossing the clavicle ipsilateral to the shunt with suspected obstruction; ShuntCheck test would interfere with standard patient care, or emergency shunt surgery that cannot be delayed is indicated; Presence of an interfering open wound or edema over any portion of the VP shunt.

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ShuntCheck<br>Participants will be administered the ShuntCheck diagnostic test. | Diagnostic Test: ShuntCheck<br>* The intervention is an FDA-cleared device utilizing a transcutaneous thermal convection to analyze shunt flow.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of ShuntCheck compared to radionuclide shunt patency study |  | 15 minutes | 
| Negative Predictive Value of ShuntCheck compared to radionuclide shunt patency study |  | 60 Minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Asymptomatic Normal Pressure Hydrocephalus, Ventriculoperitoneal Shunt
Combined Use of a Novel Cardioplegic Formula With MPS ® Using the MiECC in Isolated CABG Versus OPCABG

Study Overview
=================
Brief Summary
-----------------
A patient group receiving a novel cardioplegic formula with MPS ® (Myocardial protection system) and using the MiECC (Minimal extracorporeal circulation system) when undergoing coronary artery bypass grafting is compared to a retrospective patient group undergoing Off-pump coronary artery bypass grafting.

Official Title
-----------------
Combined Use of a Novel Cardioplegic Formula With MPS ® Using the MiECC in Isolated CABG Versus OPCABG

Conditions
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Complication of Coronary Artery Bypass Graft, Complication of Extracorporeal Circulation

Intervention / Treatment
-----------------
* Procedure: CABG


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: CABG using MPS® or OPCABG Exclusion Criteria: use of other colloid solution than Cardioplexol ® for MPS® other inventions than CABG myocardial infarction <7 days before CABG patients denial of data use
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MPS® in patients with CABG<br>Patients undergoing coronary artery bypass grafting with application of a myocardial protection system (MPS ®) and using a minimal extracorporeal circulation system (MiECC) | Procedure: CABG<br>* CABG with application of a myocardial protection system (MPS ®) and using a minimal extracorporeal circulation system (MiECC) or CABG without use of a minimal extracorporeal circulation system (Off-pump coronary artery bypass grafting = OPCABG)<br>|
| OPCABG in patients with CABG<br>Patients undergoing coronary artery bypass grafting without use of a minimal extracorporeal circulation system (Off-pump coronary artery bypass grafting = OPCABG) | Procedure: CABG<br>* CABG with application of a myocardial protection system (MPS ®) and using a minimal extracorporeal circulation system (MiECC) or CABG without use of a minimal extracorporeal circulation system (Off-pump coronary artery bypass grafting = OPCABG)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assessment of cardial biomarkers as high sensitive troponin T (hs-TrT), Creatinkinase (CK) and Creatinkinase myocardial type (CK-MB) | high sensitive troponin T (hs-TrT), Creatinkinase, (CK) Creatinkinase myocardial type (CK-MB) | perioperative during hospital stay for CABG | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality | death after coronary artery bypass grafting | 30 days after CABG | 
| need for intensive care unit | duration of stay at intensive care unit | perioperative during hospital stay for CABG | 
| occurence of dysrhythmia | rhythm disturbance after CABG | perioperative during hospital stay for CABG |
Mitochondrial Energy Production in ART (Assisted Reproductive Technology )

Study Overview
=================
Brief Summary
-----------------
Oocyte maturation requires a lot of energy, which is provided by the mitochondria via the synthesis of ATP. The majority of patients with advanced maternal age (AMA) have poor egg quality. One of the reasons depends on oxidative phosphorylation of Pyruvate to undergo maturation; on the contrary, the cells of the cumulus (CC) show great activity glycolytic so that these cells are able to provide ATP(adenosine triphosphate and energy substrates to the oocyte. The goal of this work is to analyze the mitochondrial function and energy production in oocyte donors compared with a group of women of advanced maternal age subject to a same ovarian stimulation Protocol

Official Title
-----------------
Impact on Mitochondrial Energy Production in Different Patient Populations in Women Undergoing IVF-ICSI (in Vitro Fertilization-intracytoplasmic Sperm Injection)

Conditions
-----------------
Female Infertility Due to Advanced Maternal Age

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Controls: Women between 18-35 years old who are oocyte donors and fulfill the requirements of the our program of oocyte donation according to the Spanish Law of Human Reproduction Cases: infertile women undergoing IVF due to advanced maternal age (>38 years) Exclusion criteria: For controls: Women with antral follicle count >20 or <6 follicle per ovary or with pathologies which, in the opinion of the investigator, may interfere with the treatment of ovarian stimulation Severe hypersensitivity to drugs of similar structure In the case of associated pathologies which can be considered as exclusion criteria on the part of the researcher are endocrine disruption and multi-follicular ovaries with risk of OHSS (Ovarian hyperstimulation syndrome) Be positive in serology for syphilis, toxoplasmosis, rubella, gonorrhea, hepatitis B, hepatitis C and HIV and lack of personal history and family of hereditary diseases. Cases Irregular cycles Previous Ovarian surgery Previous chemotherapy or radiotherapy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 46 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| advanced maternal age<br>Infertile women due to advanced maternal age | |
| Young patients<br>women under 35 undergoing infertility treatments | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adenosine Triphosphate (ATP) production (nmol) | ATP levels with the ATP assay kit (ab113849) Succinate dehydrogenase (SDH) activity assay kit (BioVision, USA) Mitochondrial Complex IV by colorimetric determination of oxidation-reduction processes of Cytochrome C | 15 days |