linjc16/ctgov huggingface dataset:
Medium-Term Follow-Up of Alpha-D Cervical Disk Prosthesis

Study Overview
=================
Brief Summary
-----------------
Prostheses use subsequently became prevalent and a number of studies were conducted. However, prosthesis-associated heterotropic ossification (HO) in the segments with prostheses was reported in 2005, which disrupted mobility and caused fusion. In the present study, we aimed to investigate the clinical outcomes, HO incidence, and prosthesis mobility in the patients following the operative use of Alpha-D disc prosthesis as developed and used by the authors to treat cervical disk diseases.

Official Title
-----------------
Medium-Term Radiological And Clinical Follow-Up of Alpha-D Cervical Disk Prosthesis

Conditions
-----------------
Cervical Disc Disease

Intervention / Treatment
-----------------
* Device: Alpha-D CDP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cervical disc hernia underwent cervical discectomy and received cervical disc prostheses Exclusion Criteria: history of cervical surgery, kyphotic deformity, rheumatological or other systemic diseases, severe osteophytes caused by advanced degenerative disc disease severe spinal stenosis

Ages Eligible for Study
-----------------
Minimum Age: 27 Years
Maximum Age: 59 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 |
| --- | --- |
| Alpha-D cervical disc prosthesis<br>Alpha-D cervical disc prosthesis was developed jointly by the Spine Center of Koç University Faculty of Medicine and Toledo University Bioengineering Department. It was designed as a single unit to ensure user-friendly administration for surgeons, and it was designed and manufactured to reproduce the movements of the normal cervical movement segment. | Device: Alpha-D CDP<br>* Alpha-D cervical disc prosthesis was developed jointly by the Spine Center of Koç University Faculty of Medicine and Toledo University Bioengineering Department. It was designed as a single unit to ensure user-friendly administration for surgeons, and it was designed and manufactured to reproduce the movements of the normal cervical movement segment.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heterotropic ossification | McAfee-Mehren classification | Postoperative 18-78.months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual analog scale | (0-10, 0=no pain, 10=extreme pain) | 4 and 12 months after surgery | 
| neck disability index | The questionnaire has 10 items concerning pain and activities of daily living including personal care, lifting, reading, headaches, concentration, work status, driving, sleeping and recreation. | 4 and 12 months after surgery |
Clinical Survey Study to Assess Physical Function and the Incidence of Hypoglycemia in Participants With Glycogen Storage Disease Type III

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to evaluate the incidence of hypoglycemia in adult and pediatric participants with glycogen storage disease type III (GSD III).

Official Title
-----------------
Clinical Survey Study to Assess Physical Function and the Incidence of Hypoglycemia in Patients 1 Year of Age and Over With GSD III

Conditions
-----------------
Glycogen Storage Disease Type III

Intervention / Treatment
-----------------
* Other: No Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Diagnosis of GSD III, confirmed by amylo-alpha-1,6-glucosidase 4-alpha-glucanotransferase (AGL) sequencing or glycogen debranching enzyme (GDE) enzymatic testing Key Exclusion Criteria: Participant is unwilling to remain blinded to continuous glucose monitor (CGM) data for the first 13 weeks of the study, or the Investigator determines that blinding would compromise subject safety Presence or history of any condition that, in the view of the Investigator, would interfere with participation or pose undue risk Use of any IP or investigational medical device within 30 days or 5.5 half-lives, whichever is longer, prior to screening, or during the study Note: Other criteria may apply per protocol

Ages Eligible for Study
-----------------
Minimum Age: 1 Year

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: No Intervention|No investigational product (IP) will be administered in this study|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Hypoglycemic Events During the 26-week Observation Period |  | Week 26 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bayley Scales of Infant and Toddler Development (Bayley-4) Fine Motor and Gross Motor Domain Scores |  | Up to Week 26 | 
| Bruininks-Oseretsky Test of Motor Proficiency (BOT-2) Strength and Agility Scores |  | Up to Week 26 | 
| Number of Times the Participant can Rise from a Seated to a Standing Position in a 30-second Period, as Measured by the Site-to-Stand (STS) Test |  | Up to Week 26 | 
| Percent Predicted Muscle Strength as Measured by Handheld Dynamometry (HHD) |  | Up to Week 26 | 
| Ankle Dorsiflexion, Measured Bilaterally Using Goniometry |  | Up to Week 26 | 
| Percent Predicted Distance Walked as Measured by 6-minute Walk Test (6MWT) and 12-minute Walk Test (12MWT) |  | Up to Week 26 | 
| GNE Myopathy Functional Activities Scale (GNEM-FAS) Expanded Version Domain Scores and Total Score |  | Up to Week 26 |
A Study of Optical Fusion Trans-Perineal Grid

Study Overview
=================
Brief Summary
-----------------
The purpose of this research is to evaluate a new needle guide grid utilizing Clear Guide SCENERGY - MR with a grid embedded with VisiMARKER II to autoregister and target the prostate aiding in needle placement positioning. The proceduralist can utilize this technology to find the best needle path to target within the pelvis.

Official Title
-----------------
Optical Fusion Trans-Perineal Grid

Conditions
-----------------
Prostate Biopsy

Intervention / Treatment
-----------------
* Device: Trans-Perineal Grid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Scheduled for a MR guided biopsy or ablation. One, two, or three tumor suspicious regions identified on multiparametric MRI. Tolerance for anesthesia/sedation. Ability to give informed consent. Exclusion Criteria: Presence of any condition (e.g., metal implant, shrapnel) not compatible with MRI. History of other primary non-skin malignancy within previous three years.

Ages Eligible for Study
-----------------
Minimum Age: 45 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Trans-Perineal Grid for prostate interventions<br>Subjects will have the trans-perineal guide grid placed the prostate biopsy or ablation procedure. | Device: Trans-Perineal Grid<br>* A small square piece of plastic with many holes in it placed between the legs to help guide the path of the interventional instruments and to facilitate the prostate intervention. The guide grid will help with needle placement using the grid technology.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Needle placement accuracy | Number of needle placements to successfully match target and needle tip position assessed by direct MR imaging and | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prostate Ablation Procedure
Outcomes of Pudendal InterStim

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine how many patients who have failed treatment with a sacral lead can achieve good results with a pudendal, patients satisfaction with the results of each lead, complication rates after pudendal lead placement, and how many patients have required reprogramming of their device with EMG testing( a more costly procedure).

Detailed Description
-----------------
InterStim is a bladder pacemaker device that has been in use for over 10 years for patients with voiding dysfunction. Although standard of care is to place the lead at the sacral nerve, in some patients a better response is obtained by placing the lead at the pudendal nerve. Data will be collected from the subjects medical records and a questionnaire will be mailed one time to assess patients perception of improvement and treatment satisfaction after pudendal Interstim.

Official Title
-----------------
Outcomes of Pudendal InterStim

Conditions
-----------------
Voiding Dysfunction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients having had Interstim with a pudendal lead at Beaumont Exclusion Criteria: None

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 |
| --- | --- |
| 1<br>Patient who have had implantation of an interstim. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the outcomes of pudendal interstim in terms of number of failed sacral lead patients that can be salvaged with a pudendal lead, |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the outcomes of pudendal interstim in terms of complications |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Voiding Dysfunction, Interstim
The Effect of a Serious Health Game on Children's Eating Behavior

Study Overview
=================
Brief Summary
-----------------
Background: Currently the dietary intake patterns of children do not meet the prescribed dietary guidelines. Consequently childhood obesity is one of the most serious health concerns. Therefore, innovative methods need to be developed and tested in order to effectively improve the dietary intake of children. Learning children how to cope with the overwhelming number of unhealthy food cues could be conducted effectively by serious health games. Objective: The main aim of this study was to examine the effect of a serious health computer game on young children's eating behavior and attitudes towards healthy and unhealthy foods. Methods: A cluster-randomized controlled trial with a between-subject design was conducted (N=157; 8-12 years), whereby children played a game that promoted a healthy lifestyle or were in the control condition. Children in the control condition attended regular classes and did not play a game. The game was designed in collaboration with researchers and pilot-tested before conducting the experiment among a group of children repeatedly. After one week of playing, attitudes towards food snacks and actual intake was assessed, whereby children could eat at libitum from fruits or energy-dense snacks.

Official Title
-----------------
Can Garfield Make Children Eat Healthier? A Cluster-randomized Controlled Trial to Examine the Effect of a Serious Health Game on Children's Eating Behavior

Conditions
-----------------
Eating Behavior

Intervention / Treatment
-----------------
* Behavioral: Serious health game


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: primary school between group 5 and 8 Exclusion Criteria: n.a.

Ages Eligible for Study
-----------------
Minimum Age: 7 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: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Serious health game<br>Children played a serious health game with Garfield promoting health behavior, such as less intake of energy dense snacks, drink more water, and exercise more often. | Behavioral: Serious health game<br>* Serious health game<br>|
| Experimental: control<br>Children in this condition did not play a serious health game and were in control condition. | Behavioral: Serious health game<br>* Serious health game<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| calorie intake of energy dense snacks (candy) and fruits (bananas and apples) | Energy dense snacks and fruits | 1 week after treatment |
A Safety and Tolerability Study of ABT-126 in Elderly

Study Overview
=================
Brief Summary
-----------------
The objectives of this study are to assess the safety, tolerability and pharmacokinetics of ABT-126 in elderly subjects.

Official Title
-----------------
A Multiple Dose Study of Safety, Tolerability and Pharmacokinetics of ABT-126 in Elderly Subjects

Conditions
-----------------
Alzheimer's Disease

Intervention / Treatment
-----------------
* Drug: ABT-126


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male or female subjects 65 years or greater. Has a MMSE score of 27 or higher. Exclusion Criteria: History of dementia including by not limited to Alzheimer's disease, Parkinson's disease and mult-infarct dementia. History of any significant neurological disease. Has an estimated creatinine clearance < 30 mL/min

Ages Eligible for Study
-----------------
Minimum 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: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 20mg of ABT-126 QD<br>20 mg of ABT-126 QD for 10 days | Drug: ABT-126<br>* See arm for details<br>|
| Active Comparator: 30mg and 45mg ABT-126 QD<br>30 mg and 45mg of ABT-126 QD for 21 days | Drug: ABT-126<br>* See arm for details<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability Assessments (i.e., ECG, clinical laboratory tests, vital signs, weight, AE assessment, physical and brief neurological examinations) |  | Study Days -1 thru Day 28 | 
| Assess the Pharmacokinetics |  | Study Days -1 thru Day 28 |
Clinical Trial to Evaluate the Efficacy and Safety of D064 and D701 Combination Therapy

Study Overview
=================
Brief Summary
-----------------
Clinical Trial to Evaluate the Efficacy and Safety of D064 and D701 Combination Therapy.

Official Title
-----------------
A Randomized, Double-blind, Multi-center, Therapeutic Confirmatory, Phase 3 Trial To Evaluate the Efficacy and Safety of D064 and D701 Combination Therapy in Essential Hypertension Subjects Inadequately Controlled by D064 Monotherapy

Conditions
-----------------
Essential Hypertension

Intervention / Treatment
-----------------
* Drug: D064, D701, placebo of D012
* Drug: D012, placebo of D064, placebo of D701


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who are 19 years old or older. Subjects who have voluntarily decided to participate in this clinical trial and signed ICF. Exclusion Criteria: Subjects with a history of secondary hypertension or suspected secondary hypertension Subjects who require combination administration of antihypertensive drugs other than clinical trial drugs during the clinical trial participation period Subjects with hypersensitivity or history of clinical trial drugs and similar drugs Subjects who are required to administer a combination of prohibited drugs specified in this plan during the clinical trial participation period Subjects with a history of drug or alcohol abuse or suspected patient within 24 weeks as of the time of screening Subjects who received other clinical trial drugs within 4 weeks of screening visit. Pregnant women, lactating women, or Subjects who do not agree to use appropriate contraception during the clinical trial period and for two weeks after the end of administration of the last clinical trial drug Subjects who are unable to participate in this clinical trial at the discretion of the investigator.

Ages Eligible for Study
-----------------
Minimum Age: 19 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: Experimental Group<br> | Drug: D064, D701, placebo of D012<br>* Experimental Group Subjects assigned to this group are treated with D064, D701, placebo of D012<br>* Other names: D064, D701 are consisted of antihypertensive agent.;|
| Active Comparator: Comparator Group<br> | Drug: D012, placebo of D064, placebo of D701<br>* Comparator Group Subjects assigned to this group are treated with D012, placebo of D064, placebo of D701<br>* Other names: D012 is consisted of antihypertensive agent.;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in MSSBP | Compare experimental group with comparator group | 8 weeks after drug administrations |
A Retrospective Observational Study on the Long-term Effects of Ipilimumab-treated Pediatric Participants in the Dutch Melanoma Treatment Registry (DMTR)

Study Overview
=================
Brief Summary
-----------------
This is an observational, national, retrospective study consisting of pediatric patients with advanced (spread or unremoveable) melanoma identified in the DMTR in the Netherlands

Official Title
-----------------
Long-term Follow-up of Ipilimumab-treated Pediatric Patients Enrolled in the Dutch Melanoma Treatment Registry (DMTR)

Conditions
-----------------
Melanoma

Intervention / Treatment
-----------------
* Drug: Ipilimumab


Participation Criteria
=================
Eligibility Criteria
-----------------
For more information regarding Bristol-Myers Squibb Clinical Trials, please visit www.BMSStudyConnect.com. Inclusion Criteria: Less than 18 years of age at first dose of monotherapy Ipilimumab used for treatment of advanced melanoma Histological or cytological confirmation of advanced (unresectable or metastatic) melanoma Exclusion Criteria: -Participation in a clinical trial within the past 4 weeks prior to first dose with ipilimumab or concurrently Other inclusion/exclusion criteria apply

Ages Eligible for Study
-----------------
Maximum 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 |
| --- | --- |
| Arm A: participants 12 to under 18<br> | Drug: Ipilimumab<br>* Specified dose on specified days<br>|
| Arm B: participants under 12<br> | Drug: Ipilimumab<br>* Specified dose on specified days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of Adverse Events (AEs) Grades 3-4 |  | up to 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline assessment of population demographics |  | up to 10 years | 
| Baseline assessment of comorbidities |  | up to 10 years | 
| Baseline assessment of disease characteristics |  | up to 10 years | 
| Baseline assessment of treatment history |  | up to 10 years | 
| Assessment of ipilimumab dose exposure |  | up to 10 years | 
| Assessment of changes in ipilumamb treatment: dose interruptions/discontinuations |  | up to 10 years | 
| Assessment of Ipilimumab dose frequency |  | up to 10 years | 
| Assessment of ipilimumab treatment duration |  | up to 10 years | 
| Assessment of ipilimumab number of infusions |  | up to 10 years | 
| Overall Survival (OS) |  | up to 10 years | 
| Time to progression (TTP) |  | up to 10 years | 
| Assessment of physical growth and development |  | up to 10 years |
Assessment of Pulmonary Involvement inUlcerative Colitis by Induced Sputum

Study Overview
=================
Brief Summary
-----------------
Ulcerative colitis is a systemic disease we assume that extra intestinal involvement as we describein our study( Fireman Z, Osipov A, Kivity S, Kopelman Y, Sternberg A Fireman E: Assessment of pulmonary involvement in Crohn's disease by induced sputum. Am J Gastroenterol 2000;95(30):730-734. )

Detailed Description
-----------------
Twenty Ulcerative colitis patients and 20 control subjects (all nonsmokers) without respiratory symptoms will be tested. The induce sputum by 20' inhalation of 3.5% saline using ultrasonic nebulizer. Samples will studied by differential counts of 200 cells on cytopreps stained by Giemsa. T-lymphocyte subset analyses were done by FACS using three monoclonal antibodies: CD3 = total T cells, CD4 = T helper cells, and CD8 = T suppressor-cytotoxic cells. CD4/CD8 >2.5 was considered abnormal.

Conditions
-----------------
Ulcerative Colitis

Intervention / Treatment
-----------------
* Procedure: Induced sputum (inhalation of 3.5% saline)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All the ulceratvive colitis patients without lung involvmentage 18-75 years of age Exclusion Criteria: Pregnant women Non cooperative patients Smoker Lung disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Induced sputum (inhalation of 3.5% saline)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lung involvment in Ulcerative colitis patients |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ulcerative colits, lung, Induced sputum, Our aim to evaluate lung involvement in Ulcerative colitis patients by induced sputum