linjc16/ctgov huggingface dataset:
Sedation During Microelectrode Recordings Before Deep Brain Stimulation for Movement Disorders.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to detect possible changes in the electrical activity of the Basal Ganglia related to sedation during deep brain stimulation surgery.

Detailed Description
-----------------
Deep Brain Stimulation is commonly used for the treatment of movement disorders. Electrode positioning is usually performed under local anesthesia in fully awake patients. The procedure is uncomfortable to the patients who have to remain motionless during the whole surgery. Previous reports of electrode positioning under general anesthesia was found to be less accurate. This result was probably due to the effect of the anesthetics on the electrical activity of the Basal Ganglia. The purpose of this study is to detect possible changes in the electrical activity of the Basal Ganglia related to propofol sedation. Electrical activity of single neurons will be recorded before and after sedation.

Official Title
-----------------
Changes of the Neuronal Activity in the Subthalamic Nucleus Under Propofol Sedation During Stereotactic Electrode Implantation.

Conditions
-----------------
Movement Disorders, Parkinson Disease, Parkinsonian Disorders, Dystonia, Tourette Syndrome

Intervention / Treatment
-----------------
* Procedure: Sedation with IV propofol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Candidate for Deep Brain Stimulation Surgery. Informed concent obtained. Exclusion Criteria: Suspected difficult intubation (by history or physical examination). Allergy to Propofol, eggs or soy-beans. History of sleep apnea syndrome.
Sexes Eligible for Study
-----------------
All

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 |
| --- |
|Procedure: Sedation with IV propofol|Propofol(50 microgram/kg/min.), I.V. for 5-10 minutes, Until a level of light sedation is achieved|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the electrical activity of neuron cells of the basal ganglia in the examined patients |  | Within 24 hours needed to analyse the data | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Basal Ganglia, Deep brain stimulation, Microelectrode recordings, Sedation, Propofol
Relationship Between Isometric Muscle Strength and Gross Motor Function in Children With Unilateral Cerebral Palsy

Study Overview
=================
Brief Summary
-----------------
Muscle strength can be defined as the ability of skeletal muscle to develop force for the purpose of providing stability and mobility within the musculoskeletal system, so that functional movement can take place.

Detailed Description
-----------------
Cerebral palsy describes a group of disorders of the development of movement and posture, causing activity limitation, that are attributed to non-progressive disturbances that occurred in the developing fatal or infant brain. The motor disorders of cerebral palsy are often accompanied by disturbances of sensation, cognition, communication, perception, and/or behaviour, and/or by a seizure disorder The development and changes in motor function, both natural and with therapy, can be assessed using the Gross Motor Function Measure (GMFM) created for children with CP

Official Title
-----------------
Relationship Between Isometric Muscle Strength and Gross Motor Function in Children With Unilateral Cerebral Palsy

Conditions
-----------------
Hemiplegia, Cerebral Palsy

Intervention / Treatment
-----------------
* Other: correlation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Their age between 6 and 12 years old. Grade 1and 2 according to the Modified Ashworth scale (RW and Smith, 1987). They could walk with limitation or holding on according to GMFCS (level I, II) (Palisano et al., 1997). They were able to understand and follow verbal instructions. Exclusion Criteria: Children with any visual or auditory problems. Children with any surgical interference in the lower limb. Children with any structural deformities in joints and bones of lower limbs. Children with any special medications affecting muscle functions (anti-spastic drugs). Children who suffer from other diseases or associated disorders that interfered with physical activity.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 12 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: correlation|A total of 97 children with CP between the ages of six and 12 years participated in the study. Muscle strength was measured with a handheld dynamometer. Motor function in children with CP was classified with the Gross Motor Function Classification System (GMFCS), graded with the Gross Motor Function Measure (GMFM)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gross motor function measure | standing and walking domain | 3 months | 
| Isometric muscle strength | a handheld dynamometer | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hemiplegia, Cerebral Palsy, muscle stength, gmfm
A Multicenter Randomized Controlled Study of 3D Laparoscopy Versus Endoscopy in the Treatment of Choledocholithiasis

Study Overview
=================
Brief Summary
-----------------
The incidence of choledocholithiasis is gradually rising with the increase of gallstone incidence. The popular minimally invasive treatment options include endoscopic retrograde cholangiopancreatography (ERCP) and laparoscopic common bile duct exploration (LCBDE). Currently, three-dimensional (3D) video system for laparoscopy is developed to ofer surgeon a superior depth perception and a much better user experience, thus potential increasing operation accuracy and stability. It have suggested that compared with 2D laparoscopy, 3D laparoscopy can effectively reduce operation time and numbers of errors. However, rare experimental studies are performed to evaluate the safety and effectiveness of 3D laparoscopy in choledocholithiasis patients. The aim of this study is to compare the perioperative outcomes between 3D laparoscopy and ERCP in choledocholithiasis patients through a multicenter randomized controlled design.

Official Title
-----------------
A Multicenter Randomized Controlled Study of 3D Laparoscopy Versus Endoscopy in the Treatment of Choledocholithiasis

Conditions
-----------------
Choledocholithiasis, ERCP

Intervention / Treatment
-----------------
* Procedure: 3D LCBDE
* Procedure: ERCP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The diagnosis of choledocholithiasis based on preoperative image studies including abdominal ultrasonography, computed tomography (CT), and/or magnetic resonance cholangiopancreatography (MRCP) with relevant supporting laboratory examinations Age <80y and >18y Non-emergency surgery Exclusion Criteria: Diagnosis of Mirizzi's syndrome, Acute suppurative cholangitis Detection of bilioenteric anastomosis Pathological diagnosis of cholangiocarcinoma Extended surgery due to multiple biliary strictures, Intrahepatic stones

Ages Eligible for Study
-----------------
Minimum Age: 18 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3D LCBDE group<br> | Procedure: 3D LCBDE<br>* three-dimensional (3D) video system for LCBDE (laparoscopic cholecystectomy and laparoscopic common bile duct exploration )<br>|
| Active Comparator: ERCP group<br> | Procedure: ERCP<br>* Endoscopic retrograde cholangiopancreatography (ERCP)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perioperative Complication Rate |  | 1 month after surgery |
Evaluating the Ability of Zoledronic Acid to Reduce the Rate of Subsequent Osteoporotic Fractures After a Hip Fracture

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate whether zoledronic acid given once yearly for two years to men and women after surgical repair of a recent hip fracture will significantly reduce the rate of all re-occurring (new) osteoporotic fractures. All patients will receive vitamin D and calcium.

Conditions
-----------------
Osteoporosis, Hip Fracture

Intervention / Treatment
-----------------
* Drug: Zoledronic Acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female ages 50 years or older Must have a recent hip fracture repair in the past 90 days Must be able to walk with or without assistive device (for example, using a walker) prior to the hip fracture Exclusion Criteria: Current bisphosphonate users such as aredia (pamidronate), didronel (etidronate), fosamax (alendronate), actonel (residronate), skelid (tiludronate) Other protocol-defined inclusion/exclusion criteria may apply.

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Zoledronic Acid|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Significant reduction in rate of clinical fractures after surgical repair of hip fracture |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase in total hip and femoral neck BMDs |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hip fracture, recurrent fracture, fracture, bone loss, bisphosphonate, bone mineral density, osteoporosis, zoledronic acid, geriatrics, rehabilitation, elderly, nursing home, orthopedic
Phase Ⅳ Clinical Trial to Evaluate of Renamezin in Patients With Chronic Renal Failure.

Study Overview
=================
Brief Summary
-----------------
Renamezin Capsule (an oral adsorbent) lowers indoxyl sulfate levels in patient with chronic renal failure. 120 patients with chronic renal failure(baseline serum creatinine:1.5-5.0mg/dl). Renamezin is administered 6.0mg/day. The treatment period is 2 months. The change in serum indoxyl sulfate will be evaluated.

Conditions
-----------------
Chronic Renal Failure

Intervention / Treatment
-----------------
* Drug: Renamezin capsule


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients spontaneously written consent to participate in this clinical trial men and women over age of 19 pre-dialysis patients with chronic renal failure stage patient for 3 months and patients for holding the stable state in serum creatinine 1.5mg/dl - 5.0mg/dl patients who were no noticeable change for 12weeks before screening and are expected to change is not needed during therapy in the therapy of chronic renal failure(medication and dose -related, diet therapy) Exclusion Criteria: patients with passes through the digestive tract disorders patients with uncontrolled constipation symptoms patients suffering from digestive tract ulcers and esophageal varices patients with untreated severe hypertension (DBP ≥ 120mmHg) patients hospitalized with angina pectoris, cardiovascular disease or diagnosed with serious arrhythmia or cerebrovascular disease within 6 months patients with hepatic impairment (2 times greater than the upper limit of normal levels of AST, ALT) subjects with dependency on alcohol patients with current infections pregnant women, nursing mothers Patients with a possibility of pregnancy (However, negative case can be registered) patients participating in another clinical trial in addition to the current clinical trial Patient who do not fit the clinical trial participation the legal and mentally

Ages Eligible for Study
-----------------
Minimum Age: 19 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: test<br>Renamezin capsule 2g, tid, PO | Drug: Renamezin capsule<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline of Indoxyl sulfate at 8weeks |  | 0, 8weeks |
A Study to Determine if There is a Possible Association Between NAION and Phosphodiesterase Type 5 (PDE5) Inhibitors

Study Overview
=================
Brief Summary
-----------------
Study H6D-MC-LVHQ is an observational, non-interventional, multi-center, prospective, case-crossover study to evaluate the possible association between the use of phosphodiesterase type 5 (PDE5) inhibitors and the risk of acute nonarteritic anterior ischemic optic neuropathy (NAION) in males. Subjects with newly diagnosed NAION will be asked via a structured questionnaire about their use of PDE5 inhibitors and other risk factors prior to the onset of their vision loss.

Official Title
-----------------
A Prospective Case-crossover Study to Evaluate the Possible Association Between the Use of PDE5 Inhibitors and the Risk of Acute Nonarteritic Anterior Ischemic Optic Neuropathy (NAION)

Conditions
-----------------
Nonarteritic Anterior Ischemic Optic Neuropathy

Intervention / Treatment
-----------------
* Drug: PDE5 Inhibitors


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult male subjects, at least 18 years of age, who are willing to participate in the study Participants who experienced abrupt visual loss in one eye (defined as typically less than a 1-day period or visual loss noted upon awakening) and presented for an initial visit within 45 days of onset of NAION symptoms to an ophthalmologist that resulted in a diagnosis of Suspected NAION by the investigator Exclusion Criteria: Previous history of NAION Previous history of arteritis (anywhere in the body) or clinical or diagnostic testing evidence of temporal arteritis History of glaucoma in either one or both eyes History of multiple sclerosis or diagnostic testing evidence of optic neuritis Have dementia or other reasons for memory impairment in the opinion of the investigator Have participated in other non-observational studies within 3 months of NAION onset

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1<br>Participants with NAION who have used PDE5 inhibitors | Drug: PDE5 Inhibitors<br>* Observational study of participants who have been prescribed phosphodiesterase type 5 (PDE5) inhibitors by their physician during routine clinical practice.<br>* Other names: vardenafil;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-Day Person Time Analysis Risk of NAION Associated With PDE5 Inhibitor Use | Total participant days of PDE5 inhibitor exposure within 30 days prior to onset of NAION. | 30 days prior to NAION onset | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NAION
Helping Moms Who Smoke

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to learn how women's smoking changes during their pregnancy and as a new mom, and to assess the help they receive from their health care providers.

Detailed Description
-----------------
Approximately 90% of women who smoked before pregnancy will be smokers within one year of delivery . This occurs even though half who smoke quit during the course of pregnancy. This is an observational, cohort study of pregnant women who smoked in the six months before becoming pregnant. Women will be followed from the first trimester to one year after the birth of their babies. The results of this study will help us to describe women's' views on the quality of tobacco counseling they receive from their doctors; understand patterns of smoking and quitting throughout pregnancy and after childbirth; and provide information needed to develop an intervention to help women quit.

Official Title
-----------------
Enhancing the Delivery of Tobacco Treatment During Pregnancy and Postpartum Though Systems-Change

Conditions
-----------------
Smoking Cessation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Smoked within six months prior to becoming pregnant or current smoking Smoked at least 100 cigarettes Pregnant English speaking Access to a cell phone Willing to receive and send text messages. Exclusion Criteria: Quit for longer than 6 months before becoming pregnant

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| Pregnant Smokers<br>Participants are pregnant women who smoked in the six months prior to their pregnancy. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smoking status | The investigators will assess 7-day point prevalence smoking status over multiple time-points over the study period | 1 year post-partum |
Clinical Study to Evaluate the Tolerability, Safety and Efficacy of Enteric-coated Mycophenolate Sodium After Equimolar Conversion From Mycophenolate Mofetil (MMF) in Patients With Renal Transplant

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate the safety and efficacy of equimolar conversion from MMF to enteric-coated mycophenolate sodium, in renal transplant patients receiving cyclosporine.

Official Title
-----------------
Open-label Study to Evaluate the Tolerability, Safety and Efficacy of the Equimolar Conversion From Mycophenolate Mofetil (MMF) to Enteric-Coated Mycophenolate Sodium (EC-MPS) in Patients With Renal Transplant

Conditions
-----------------
Prevention of Acute Rejection After Kidney Transplantation

Intervention / Treatment
-----------------
* Drug: Enteric-Coated Mycophenolate Sodium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: First or second (single or double) deceased or living donor kidney transplant received at least six months previously; Immunosuppressive therapy with cyclosporin and mycophenolate mofetil (MMF); Receiving an MMF dose of <2/g/day because of any adverse event and/or altered laboratory test result attributed to MMF Exclusion Criteria: • Subjects expected to discontinue cyclosporin therapy; Patients with thrombocytopenia (<75,000/mm3), an absolute neutrophil count of <1,500/mm3 and/or leukopenia (<2,500/mm3), or anemia (hemoglobin <6 g/dl) at baseline; Patients experiencing an acute rejection in the previous two months, with inadequate (creatininemia >2.5 mg/dL) or worsening renal function in the previous two months.

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Enteric-Coated Mycophenolate Sodium|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Renal function, measured as calculated creatinine clearance according to the Cockcroft and Gault formula |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of biopsy proven acute rejection |  |  | 
| Overall Gastrointestinal disturbances as measured by visual analog scales (upper and lower gastrointestinal symptoms) |  |  | 
| Quality of life related to GI symptoms (GIQLI scale) |  |  | 
| Full blood count |  |  | 
| Gastrointestinal Adverse Events (check-list) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Kidney transplantation; acute rejection; gastrointestinal adverse events; quality of life; mycophenolate sodium.