linjc16/ctgov huggingface dataset:
Autism in Adult Patients and the Effects on Caregivers

Study Overview
=================
Brief Summary
-----------------
Background: The number of adults with autism is expected to rise significantly in the near future, due to two main reasons: First, a dramatic increase in the estimates of the prevalence of autism starting in the mid 1980s; Second, the clinical diagnosis of autism was first introduced during the 1950s, and those diagnosed with autism back then are only now entering middle age. Few studies, however, have focused on the outcomes of adult autistic individuals, and very little is known about the course of autism in adulthood and on the familial burden resulting from caring for an autistic adult. We therefore propose to study adult outcomes in autism, and to examine the influence of raising an autistic individual on the parents. Working hypothesis and aims: The primary objectives of the study are: Determine clinical status and functioning of autistic adults. Study the influence of raising and caring for an individual with autism on the well-being of the parents.

Official Title
-----------------
Autism: Long Term Course and Impact

Conditions
-----------------
Autism

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Autism or autism spectrum disorder Understands the informed consent Hebrew Speaker Exclusion Criteria: Severe acute or chronic illness Substance abuse In control subjects: Autism or autism spectrum disorder in subject or siblings In control subjects: participating sibling

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 45 Years

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

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

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
-----------------
birth cohort, Autism spectrum disorders, long-term outcomes, caregiver burden, nested case-control study
Comparison for Pethidine Requirement in Patients Received Spinal Morphine 0.2 and 0.3 mg for Post Lobectomy Analgesia

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the amount of total pethidine requirement during the 48 hour postoperative period after receiving spinal morphine 0.2 and 0.3 mg.

Detailed Description
-----------------
Thoracotomy causes severe pain to the patients. Continuous thoracic epidural is a gold standard for postoperative pain. However, it needs skill. There are many alternatives such as spinal morphine, intercostal nerve block, cryoalangesia or interpleural block.

Official Title
-----------------
Comparison for Pethidine Requirement in Patients Received Spinal Morphine 0.2 and 0.3 Milligram for Post Lobectomy (Lung) Analgesia

Conditions
-----------------
Solitary Mass, Lung Diseases

Intervention / Treatment
-----------------
* Drug: spinal morphine 0.3 mg
* Drug: spinal morphine 0.2 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 year and < 70 year Patient ASA physical status I-III. Scheduled for thoracotomy with lobectomy. Can operate a patient-controlled analgesia (PCA) device. Exclusion Criteria: Known hypersensitivity to morphine or pethidine History of bleeding tendency. Known case of infection at the back Patient refuse for spinal anesthesia History of cerebrovascular disease. Scheduled for video-assisted thoracoscopic lobectomy. Need mechanical ventilatory support during postoperative period

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: spinal morphine 0.2 mg<br>spinal morphine 0.2 mg | Drug: spinal morphine 0.2 mg<br>* spinal morphine 0.2 mg<br>* Other names: morphine;|
| Active Comparator: spinal morphine 0.3 mg<br>spinal morphine 0.3 mg | Drug: spinal morphine 0.3 mg<br>* spinal morphine 0.3 mg<br>* Other names: morphine;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pethidine requirement | Total pethidine requirement during 48 hours postoperative | 48 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
thoracotomy, postoperative pain, spinal morphine
Chloroprocaine Spinal for Outpatient Knee Surgery

Study Overview
=================
Brief Summary
-----------------
Outpatient knee surgeries with duration of less than one hour pose a challenge to the use of spinal anesthesia given that traditional agents remain in effect for 2-3 hours, thus creating a mismatch between length of surgery and anesthetic resolution. The investigators hypothesize that the use of chloroprocaine can combine the benefits of a short spinal anesthetic while avoiding the side effects of a general anesthetic, thus promoting earlier discharge.

Official Title
-----------------
A Comparison Study to Facilitate Earlier Discharge: Spinal Versus General Anesthesia for Outpatient Knee Surgeries, a Randomized Controlled Study

Conditions
-----------------
Knee Arthroscopy

Intervention / Treatment
-----------------
* Drug: Chloroprocaine
* Drug: Mepivacaine
* Drug: General Anesthetics


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients scheduled for a knee arthroscopy that is anticipated to be less than one hour Age 18 to 80 years Ability to follow study protocol English speaking Exclusion Criteria: Hepatic or renal insufficiency Younger than 18 years old and older than 80 Allergy or intolerance to one of the study medications Chronic gabapentin/pregabalin use (regular use for longer than 3 months) Chronic opioid use (taking opioids for longer than 3 months) Patients unable to undergo a spinal anesthetic or Laryngeal Mask Airway (LMA)/GA or patient refusal to spinal anesthesia or LMA/GA

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chloroprocaine<br> | Drug: Chloroprocaine<br>* A spinal anesthetic with 2% chloroprocaine (2cc or 40 mg) will be performed<br>|
| Active Comparator: Mepivacaine<br> | Drug: Mepivacaine<br>* A spinal anesthetic with 1.5% Mepivacaine (3cc or 45 mg) will be performed<br>|
| Active Comparator: General Anesthesia<br> | Drug: General Anesthetics<br>* General anesthetics will be administered intravenously<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Readiness for Discharge | Defined as duration from arrival in the post-anesthesia care unit (PACU0 to the time patient meets the discharge criteria from the post anesthesia discharge scoring system (PADSS) for home readiness after ambulatory surgery | Determine within 24 hours after surgery |
Efficacy of Biphasic Insulin Aspart 30 in Type 2 Diabetics Failing on OADs

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in the United States of America (USA). The aim of this trial is to investigate the effectiveness of biphasic insulin aspart 30 in type 2 diabetics not achieving blood sugar levels when treated with oral anti-diabetics drugs (OADs) with or without basal insulin therapy.

Official Title
-----------------
NovoLog® Mix 70/30 (Biphasic Insulin Aspart 70/30) Titrate-To-Target: An Observational Study of the Efficacy of NovoLog® Mix 70/30 in Patients With Type 2 Diabetes Mellitus Not Achieving Glycemic Targets on OADs With / Without Once Daily Basal Insulin Therapy

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: biphasic insulin aspart 30


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes mellitus for at least 12 months HbA1c: 7.5-10.0% An antidiabetic regimen that has been stable for at least 3 months Able and willing to perform SMBG testing as per protocol Exclusion Criteria: Use of any insulin preparations other than NPH or glargine within the past 6 months Pregnancy, breastfeeding, intention to become pregnant within the next 12 months, or judged to be using inadequate contraceptive measures (adequate contraceptive measures includes: sterilization, intrauterine devices, oral contraceptives, or consistent use of barrier methods) Known or suspected allergy to trial product or agents related to trial product

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: biphasic insulin aspart 30<br>* Treat-to-target dose titration scheme<br>* Other names: NovoMix®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects achieving HbA1c below 6.5% |  | after 16, 32 and 48 weeks, respectively |
LEO 32731 for the Treatment of Moderate to Severe Psoriasis Vulgaris

Study Overview
=================
Brief Summary
-----------------
A study of LEO 32731 in the treatment of psoriasis vulgaris

Detailed Description
-----------------
This is an investigation of the efficacy of LEO 32731 30 mg as compared to placebo after 16 weeks of oral treatment of psoriasis vulgaris

Official Title
-----------------
LEO 32731 for the Treatment of Moderate to Severe Psoriasis Vulgaris

Conditions
-----------------
Psoriasis Vulgaris

Intervention / Treatment
-----------------
* Drug: LEO 32731
* Drug: LEO 32731 Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed and dated informed consent Aged between 18 years and 65. Males or females of non-childbearing potential. Clinical diagnosis of psoriasis vulgaris with or without psoriatic arthritis Have moderate to severe psoriasis vulgaris Candidates of systemic anti-psoriatic treatment and/or phototherapy Exclusion Criteria: Subjects with therapy resistant psoriasis Previously exposed to apremilast Systemic treatment with biological therapies, whether marketed or not, with a possible effect on psoriasis vulgaris Systemic treatment with all other therapies (other than biologics) with a possible effect on psoriasis vulgaris

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: LEO 32731 tablet<br>LEO 32731 30 mg two times daily for 16 weeks | Drug: LEO 32731<br> <br> |
| Placebo Comparator: LEO 32731 Placebo tablet<br>LEO 32731 placebo two times daily for 16 weeks | Drug: LEO 32731 Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psoriasis Area and Severity Index (PASI) at week 16 |  | Week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects with Physician's Global Assessment of Disease Severity (PGA) treatment success, defined as clear or almost clear at week 16 |  | Week 16 | 
| Itch evaluated by itch Numerical Rating Scale (NRS) at week 16 |  | Week 16 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Psoriasis
Accuracy of Arch Analysis in Mixed Dentition Using Digital Models Versus Plaster Ones.

Study Overview
=================
Brief Summary
-----------------
Accuracy of arch analysis in mixed dentition using digital study models versus the plaster models using Tanaka and Johnston prediction equation:

Detailed Description
-----------------
Space analysis is traditionally performed by diagnostic measurements that have been obtained from plaster dental casts through measurements which might be influenced by subjective interpretation and bias when constructed. *So another method of diagnostically measuring study models was introduced (Digital software). This system creates digital images of dental casts with software. From the digitized models, various analyses and routine measurements could be done that might accelerate and solve many problems and difficulties associated with storage, retrieval, reproduction, communication, and breakage of conventional plaster casts. Taking an impressions for a mixed dentition aged children. Perform a measurements using Tanaka and Johnston equation for an arch analysis using a caliper and 3Shape ortho-analyzer software. Casts will be scanned using the 3D scanner then by using the 3shape software measurements will be held according to Tanaka and Johnstopn prediction equation.

Official Title
-----------------
Accuracy of Arch Analysis in Mixed Dentition Using Digital Study Models Versus the Plaster Models Using Tanaka and Johnston Prediction Equation:

Conditions
-----------------
Dental Malocclusion

Intervention / Treatment
-----------------
* Diagnostic Test: 3shape ortho analyzer software


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged range from 6-10. patients medically free from any syndromes that could affect the normal eruption. Normal radiographical findings in teeth eruption. Erupted lower incisors. Exclusion Criteria: Extracted lower 1st permanent molar. congenital missing of incisors. Badly decayed permanent incisors or 1st molar that could compromise the measurements. Any sensitivity to any of the impression materials.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 10 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: 3shape ortho analyzer software|Arch analysis , manual analysis , digital analysis , Mixed dentition , Tanaka and Johnston|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| accuracy of digital models in arch analysis. | using digital models through software(3shape ortho analyzer) to evaluate it's accuracy in arch analysis through prediction equation(Tanaka and Johnston equations)versus plaster models by using manual caliper. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Arch analysis, Mixed dentition,Tanaka & Johnston
Retinal Function in Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
Parkinson's disease (PD) is a neurodegenerative disorder characterized by muscle rigidity, tremor, a slowing of physical movement (bradykinesia) and, in extreme cases, a loss of physical movement. The primary symptoms are the results of decreased stimulation of the motor cortex arising from the basal ganglia normally caused by the insufficient formation and action of dopamine, which is produced in the dopaminergic neurons of the brain. Secondary symptoms may include high level cognitive dysfunction and subtle language problems. Included in the symptomatology experienced by patients with PD, visual abnormalities are not uncommon. Visual changes among patients with PD appear not only dynamic in nature, but differentially affected based on the course of the disease and, perhaps more importantly, its treatment. Parkinson's disease has significant ramifications not only in observation of irregularities in vision, but how vision interacts with entrainment of the circadian clock. The purpose of this study is to examine the relationship between PD and operation of a unique set of retinal cells known to regulate the circadian clock and sleep-wake cycles in human subjects.

Official Title
-----------------
Intrinsically Photosensitive Retinal Ganglion Cells in Parkinson's Disease

Conditions
-----------------
Parkinson's Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18-64 best corrected visual acuity of 20/25 or better in each eye - Exclusion Criteria: evidence of any form of eye disease, inability to understand and sign informed consent. -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pupillary threshold |  | one | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
retina, Parkinson's disease, ganglion cell, pupillary
Local Administration of Tranexamic Acid in Upper Gastrointestinal Hemorrhage

Study Overview
=================
Brief Summary
-----------------
Upper gastrointestinal hemorrhage is a frequently diagnosis in emergency departments. Although new drugs and endoscopic techniques were easily applied in various settings in this condition, the role of local administered therapies such as antifibrinolytic agents remain unclear. The investigators aimed to compare standard therapy (proton pump inhibitors, endoscopic treatments etc.) and standard therapy + local administered tranexamic acid in upper gastrointestinal hemorrhage in a double-blind, randomized trial.

Official Title
-----------------
Local Administration of Tranexamic Acid in Upper Gastrointestinal Hemorrhage: A Double-Blind, Randomized, Placebo-Controlled Trial

Conditions
-----------------
Gastrointestinal Hemorrhage, Tranexamic Acid, Emergency Department, Antifibrinolytic Agents

Intervention / Treatment
-----------------
* Drug: Tranexamic acid 5%
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients presenting with upper gastrointestinal hemorrhage to the ED Patients older than 18 years Patients who agree to participate the study by reading and signing the informed consent form Exclusion Criteria: Patients younger than 18 years Patients who do not agree to participate the study Documented or declared allergy to tranexamic acid Upper gastrointestinal hemorrhage secondary to trauma Upper gastrointestinal hemorrhage secondary to esophageal varices Patients who cannot undergo to endoscopy for any reason History for thromboembolic disease Patients with renal impairment

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tranexamic acid 5%<br>Tranexamic acid 5%, 2000 mg (40 mL) in 60 mL normal saline (0.9%) solution (total 100 mL) | Drug: Tranexamic acid 5%<br>* Via nasogastric tube, 100 mL<br>|
| Placebo Comparator: Placebo<br>0.9% normal saline solution (total 100 mL) | Drug: Placebo<br>* Via nasogastric tube, 100 mL<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | In- or out of hospital mortality | One month | 
| Re-bleeding | Recurrent upper gastrointestinal hemorrhage | One month | 
| Endoscopic intervention need |  | One month | 
| Surgical intervention need |  | One month | 
| ED revisit |  | One month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of stay in the hospital |  | One month | 
| Administered blood products in the ED |  | One month | 
| Adverse reactions | Thromboembolic events, anaphylaxis | One month |