linjc16/ctgov huggingface dataset:
Local Triamcinolone Injection in Active Thyroid Orbitopathy

Study Overview
=================
Brief Summary
-----------------
Comparing the effectiveness of subconjunctival and peribulbar Triamcinolone injection to systemic Steroid therapy for patients with active thyroid orbitopathy.

Detailed Description
-----------------
Local Steroid treatment may help in active thyroid orbitopathy. till today, systemic Steroids are the treatment for active thyroid orbitopathy which is associated with systemic adverse effects. In this study the investigators want to compare the effectiveness of local Triamcinolone therapy for active thyroid orbitopathy.

Official Title
-----------------
Peribulbar and Subconjunctival Kenalog Injection for Thyroid Orbitopathy

Conditions
-----------------
Thyroid Disease

Intervention / Treatment
-----------------
* Drug: Triamcinolone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age>18 years. Active thyroid orbitopathy according to clinical activity score>=3. Exclusion Criteria: Intraorbital or active infections. Tuberculosis. Other orbital disease. Pregnancy. Compressive optic neuropathy. Systemic steroid therapy within 6 months of study start.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Triamcinolone<br> | Drug: Triamcinolone<br>* Subconjunctival and peribulbar, 40 mg/ml, 3 monthly injection<br>* Other names: kenalog;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparing the effectiveness of subconjunctival and peribulbar Triamcinolone injection to systemic Steroid therapy for patients with active thyroid orbitopathy . | Every month, each participant will undergo several tests : blood sugar, full ocular examination, color test, visual field and ultrasound test for measuring the thickness of extraocular muscles.Clinical activity score for thyroid orbitopathy will be assesed too. The results of the clinical and ultrasonogrophic findings will determine the effectiveness of the treatment. A patient with deterioration of thyroid orbitopathy during the research, will be treated by systemic Steroids in addition to the local injections. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To check if the level of TSH Receptor antibodies are affected by the local injection. | A blood test for TSH Receptor antibodies will be taken for every patient at the beginnig of the research and after 4 months. | 4 months |
Aripiprazole in Patients With Psychosis Associated With Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical research study is to assess the safety and tolerability of aripiprazole in patients with psychosis associated with Parkinson's disease.

Official Title
-----------------
An Open-Label Study of Aripiprazole to Evaluate the Safety and Tolerability in Patients With Psychosis Associated With Parkinson's Disease

Conditions
-----------------
Parkinson's Disease, Psychoses

Intervention / Treatment
-----------------
* Drug: aripiprazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary diagnosis of idiopathic Parkinson's disease. Psychosis related to Parkinson's disease. Exclusion Criteria: Psychosis present prior to diagnosis of Parkinson's disease.

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: aripiprazole<br>* Tablets, Oral, 1-10mg, Once daily, 6 weeks.<br>* Other names: Abilify;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Assessments |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Psychosis, Parkinson's Disease
A Retrospective Natural History Study of Patients With Lysosomal Acid Lipase Deficiency/Wolman Phenotype

Study Overview
=================
Brief Summary
-----------------
This is a Natural History study to characterize key aspects of the clinical course of lysosomal acid lipase (LAL) deficiency/Wolman phenotype in patients.

Detailed Description
-----------------
The objective of this study is to characterize key aspects of the clinical course of LAL deficiency/Wolman phenotype in patients including, but not limited to, survival and growth parameters, to serve as a historical control to inform the evaluation and care of affected patients and to provide a reference for efficacy studies of enzyme replacement or other novel therapies.

Official Title
-----------------
A Retrospective Natural History Study of Patients With Lysosomal Acid Lipase Deficiency/Wolman Phenotype

Conditions
-----------------
Lysosomal Acid Lipase Deficiency, Wolman Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Deceased patients diagnosed with LAL deficiency/Wolman phenotype in 1985 or later provided they have required data points in their medical records. Exclusion Criteria: Patients will be excluded from the study if the required data points for inclusion are not available. Living LAL deficiency/Wolman phenotype patients will be excluded
Sexes Eligible for Study
-----------------
All

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Death | The time to death will be analyzed using Kaplan-Meier curves. Estimates (with exact 95% confidence interval [CI]) of the median and the lower and upper quartiles of time to death will be derived. | Up to two years. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
LAL Deficiency, LIPA, Wolman disease, Wolman Phenotype, Early Onset LAL Deficiency, Acid Lipase Deficiency
Safety and Tolerability of Retinoid QLT091001 in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
Healthy volunteer subjects will receive retinoid QLT091001 once-daily for 7 days for safety observation.

Official Title
-----------------
A Phase 1a, Repeat-Dose Escalation Study to Investigate the Safety and Tolerability of a 7-Day Repeated Dose of Retinoid QLT091001 in Healthy Volunteers

Conditions
-----------------
Healthy Human Volunteers

Intervention / Treatment
-----------------
* Drug: QLT091001


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy subjects with ECG within normal limits and normal blood pressure and resting heart rate Exclusion Criteria: Subjects with any clinically important abnormal physical finding at screening. Subjects who are actively participating in an experimental therapy study or who have received experimental therapy within 60 days of baseline. Female subjects who are either pregnant or lactating.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: QLT091001|7-day repeated dose|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical laboratory tests, ECG, vital signs, color vision, and visual acuity |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  | 30 days |
Omnigen in Acute Chemical Eye Injuries

Study Overview
=================
Brief Summary
-----------------
evaluation of the role of Omnigen in acute chemical eye injuries

Detailed Description
-----------------
prospective interventional study included patients with different degrees of acute chemical eye injuries were treated by Omnigen and followed up for one month

Official Title
-----------------
Clinical Outcomes of Low Temperature Vacuum-dehydrated Amnion Membrane (Omnigen) in Treatment of Acute Chemical Eye Injuries

Conditions
-----------------
Acute Chemical Eye Injuries

Intervention / Treatment
-----------------
* Procedure: vacuum-dehydrated amnion membrane (omnigen)
* Device: the lens loaded with Omnigen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: acute chemical eye injury Exclusion Criteria: absent or shallow fornices symblepharon interfering with lens placement

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: the lens loaded with Omnigen<br>patients with acute chemical eye injury treated with omnigen | Procedure: vacuum-dehydrated amnion membrane (omnigen)<br>* applying the lens loaded with Omnigen on the cornea<br>* Other names: application of amnilenz;Device: the lens loaded with Omnigen<br>* the lens loaded with Omnigen<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Epithelial healing | slit lamp examination with cobalt blue light after installing fluroscein drops | 1 week | 
| limbal ischaemia | slit lamp examination of the clock hours of vascularity around the limbususing both Due classification and Roper Hall | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| omnigen tolerability | questionnaire for the patients asking about discomfort sensation or the need to patch the eye | 1 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
amniotic membrane, chemical eye injury
Prostatectomy Prospective Database

Study Overview
=================
Brief Summary
-----------------
The purpose of establishing the database is to evaluate the effects of surgical removal of the prostate (prostatectomy) and cryosurgery on prostate cancer, quality of life, and overall health.

Detailed Description
-----------------
The purpose of establishing the database is to evaluate the effects of surgical removal of the prostate (prostatectomy) and cryosurgery on prostate cancer, quality of life, and overall health. Participation in the study will allow collection of medical information related to prostate cancer treatment from hospital and doctor's office records. Questionnaires will be completed reflecting bladder, bowel, and sexual function, and quality of life at three, six, twelve, eighteen, and twenty-four months after surgery, and yearly thereafter.

Official Title
-----------------
Prostatectomy Database

Conditions
-----------------
Prostate Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: males greater than 18 years of age patients having prostatectomy or cryosurgery for the treatment of prostate cancer at William Beaumont Hospital. Exclusion Criteria: dementia

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prostate Cancer, Prostatectomy
Spinal Anaesthesia for Knee Arthroscopy: Does Lignocaine Shorten the Effect of Bupivacaine

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to investigate if a small amount of lignocaine added to bupivacaine for spinal anesthesia to patients planned for arthroscopic knee surgery, can shorten the duration of the sensoric and the motoric blockade.

Official Title
-----------------
Spinal Anaesthesia for Knee Arthroscopy: Does Lignocaine Shorten the Effect of Bupivacaine?

Conditions
-----------------
Spinal Anesthesia

Intervention / Treatment
-----------------
* Drug: Lidocaine
* Drug: bupivacaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient want spinal anaesthesia No contradictions against spinal anaesthesia Healthy people (ASA-score 1 or 2) Body mass index < 35 and between 155 and 190 cm Exclusion Criteria: Known allergic reactions to planned drugs Neurologic disturbances Diabetes

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Bupivacaine<br>Bupivacaine as used routinely | Drug: bupivacaine<br> <br> |
| Placebo Comparator: Lidocaine added to bupivacaine<br>lidocaine is added to bupivacaine | Drug: Lidocaine<br> <br> Drug: bupivacaine<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of spinal blockade |  | Repeating monitoring every 15 minutes after applying the blockade, up to 360 minutes. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to fulfillment of discharge criteria from the hospital. |  | Evaluated every 15 minutes after the operation up to 360 minutes. On average 200 to 300 minutes. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Spinal anaesthesia, Bupivacaine, Lidocaine, Duration of blockade
Follow-up of Extreme Neonatal Hyperbilirubinemia in 5-10 Year Old Children: a Danish Population Based Study

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to investigate whether infants with total serum bilirubin > 450 umol/L in the neonatal period and no symptoms or no more than early acute bilirubin encephalopathy develop long term sequelae with impairment of motor development, hearing and executive function compared with a control group.

Detailed Description
-----------------
Children in both the exposed and the non-exposed group were examined by use of the MABC-2 and pure tone audiometry by the responsible examiner for the study, Pernille Vandborg, MD. The aim was to see whether the exposed group suffered any long term sequelae to the extreme neonatal hyperbilirubinemia, i.e. impaired motor development or hearing impairment, compared to a control group. The examinations took place at the local hospital.

Official Title
-----------------
Follow-up of Extreme Neonatal Hyperbilirubinemia in 5-10 Year Old Children: a Danish Population Based Study

Conditions
-----------------
Neonatal Hyperbilirubinemia

Intervention / Treatment
-----------------
* Procedure: Movement assessment battery for children - 2


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Gestational age > 35 weeks Total serum bilirubin > 450 umol/L in the neonatal period Born in the period 01.01.2000 - 31.12.2005 Exclusion Criteria: Acute intermediate or advanced bilirubin encephalopathy

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 10 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 |
| --- | --- |
| Exposed group<br>Children age 5-10 years old who had a total serum bilirubin > 450 umol/L in the neonatal period | Procedure: Movement assessment battery for children - 2<br>* A standardised test developed to identify developmental difficulties in children.<br>* Other names: MABC-2;|
| Non-exposed group<br>Matched 1:1 to the exposed group on gender, age, gestational age and municipality of residence | Procedure: Movement assessment battery for children - 2<br>* A standardised test developed to identify developmental difficulties in children.<br>* Other names: MABC-2;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motor development | Delayed motor development for children in the exposed group compared to children in the non-exposed group | Age 5-10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Neonatal hyperbilirubinemia, Follow-up, Motor development, Hearing, Executive function
A Clinical Study to Compare Combination of Aliskiren+ HCTZ to Irbesartan+ HCTZ or Amlodipine+ HCTZ or HCTZ Alone in Obese Hypertensive Not Responsive to HCTZ 25 mg

Study Overview
=================
Brief Summary
-----------------
To evaluate the blood pressure lowering effects of the combination of aliskiren 300 mg and HCTZ 25 mg in obese patients with essential hypertension inadequately treated with HCTZ 25 mg, compared to irbesartan or amlodipine with HCTZ or HCTZ alone.

Official Title
-----------------
A 12-week Randomized Double-blind Parallel Group Study to Evaluate the Efficacy and Safety of the Combination Aliskiren With HCTZ Compared to Irbesartan or Amlodipine With HCTZ or HCTZ Alone in Hypertensive Patients With BMI ≥ 30 kg/m2 Not Adequately Responsive to HCTZ 25 mg

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: aliskiren


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients with essential hypertension Patients with body mass index ≥ 30 kg/m2 Exclusion Criteria Severe hypertension History or evidence of a secondary form of hypertension History of Hypertensive encephalopathy or cerebrovascular accident. Other protocol-defined inclusion exclusion criteria also apply.

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: aliskiren|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in mean sitting diastolic blood pressure after 8 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in mean sitting systolic blood pressure after 8 weeks |  |  | 
| Evaluate number mean sitting systolic/diastolic response from baseline to weeks 4 and 8 |  |  | 
| Mean sitting diastolic blood pressure < 90 mmHg or a reduction of > 10 mmHg after week 8 |  |  | 
| Achieve mean sitting blood pressure control target of < 140/90 mmHg after week 8 |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertension, aliskiren, blood pressure, irbesartan, amlodipine, hydrochlorothiazide
MoTHER Buddy Program

Study Overview
=================
Brief Summary
-----------------
The purpose of the 12-week study is to determine if competing a physical activity program with a buddy helps increase daily physical activity when compared to completing the same physical activity program without a buddy.

Official Title
-----------------
With Help From Buddies: The Impact of Social Support Using Mobile Technology on Physical Activity Among Women With Young Children

Conditions
-----------------
Physical Activity, Obesity

Intervention / Treatment
-----------------
* Behavioral: mHealth Physical Activity
* Behavioral: Buddy-partnered exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Physically inactive, having at least one child aged less than 5 years, having at least one family member or friend who can support physical activity engagement and reside in the same community, having access to computer and phone, and overweight/obese (Body Mass Index: 23 kg/m2 or more) Exclusion Criteria: Having known medical conditions that prevent regular physical activity and current participation in other lifestyle modification programs

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 44 Years

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

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Buddy<br>Physical activity plus having a buddy | Behavioral: mHealth Physical Activity<br> <br> Behavioral: Buddy-partnered exercise<br> <br> |
| Active Comparator: Control<br>Physical activity only | Behavioral: mHealth Physical Activity<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily steps |  | weekly during study period, up to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight |  | Changes in weight over the 12-week study period | 
| Waist Circumference (WC) |  | Changes in WC over the 12-week study period | 
| Hip Circumference (HC) |  | Changes in HC over the 12-week study period |