linjc16/ctgov huggingface dataset:
Biology of Osteosarcoma (BOOST) Registry and Biobank

Study Overview
=================
Brief Summary
-----------------
Osteosarcoma is very rare cancer of the bone. The investigator started the BOOST registry and biobank to make sure every patient has the opportunity to participate in research.

Detailed Description
-----------------
Summary to include: Samples of saliva, blood and/or other stored material such as slides or leftover diagnostic material. If available the investigator may ask you for deciduous (baby) teeth. Questionnaire information, including health history, growth and development, physical activity and family medical history information. If you have been diagnosed with a osteosarcoma or another condition the investigator is interested inthe investigator will ask you release medical record information relating to diagnosis and treatment of osteosarcoma, other cancers, blood disorders, and similar conditions. If this step applies to you then you will be asked to sign a separate form. You may be asked to contact your biological parents and full biological siblings to ask them about participating in the study. If you agree you may be contacted in the future. You will be able to decline any future information or studies at any point.

Official Title
-----------------
Biology of Osteosarcoma (BOOST) Registry and Biobank

Conditions
-----------------
Osteosarcoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Proband Inclusion criteria: A diagnosis or suspected diagnosis of osteosarcoma (ICCC 9180-9200) Family member inclusion criteria: Biological parents and full biological siblings of a case diagnosed with osteosarcoma (ICCC 9180-9200) Exclusion Criteria: Does not understand English.

Ages Eligible for Study
-----------------
Minimum Age: 0 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Osteosarcoma patients and family members<br>Osteosarcoma patients and family members | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine if genes can determine osteosarcoma | To do this the investigator will compare the genes of people with osteosarcoma to the genes of people who do not have these conditions. | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteosarcoma, Bone cancer, Family-based study
Isolated ACTH Deficiency in Patients With Hashimoto Thyroiditis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether patients with Hashimoto thyroiditis and impaired well-being may have a partial secondary adrenocortical insufficiency.

Detailed Description
-----------------
Many patients with Hashimoto thyroiditis who are correctly substituted with thyroid hormones have an impaired well-being. in some people an isolated ACTH deficiency was found. In this study a 1 µg ACTH test is performed to evaluate the adrenocortical function.

Official Title
-----------------
Isolated ACTH Deficiency in Patients With Hashimoto Thyroiditis

Conditions
-----------------
Hashimoto Disease, Adrenal Insufficiency

Intervention / Treatment
-----------------
* Drug: synacthen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hashimoto thyroiditis euthyreot thyroid function with levothyroxin therapy written informed consent Exclusion Criteria: • hypothyroidism of other origin pregnancy and lactation oral contraception glucocorticoid therapy during the last 2 months History of malignancy or chronic infections (Hepatitis, HIV)

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

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

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

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

Design Details

Primary Purpose: Diagnostic
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>healthy people without Hashimoto disease receive a 1µg ACTH stimulation test | Drug: synacthen<br>* 1 µg synacthen in the vein<br>* Other names: ACTH;|
| Other: 2<br>patients with Hashimoto disease with well being receive a 1 µg ACTH stimulation test | Drug: synacthen<br>* 1 µg synacthen in the vein<br>* Other names: ACTH;|
| Other: 3<br>patients with Hashimoto disease an impaired well-being receive a 1 µg ACTH stimulation test | Drug: synacthen<br>* 1 µg synacthen in the vein<br>* Other names: ACTH;|
| Other: 4<br>patients with Hashimoto disease and negative TPO antibodies receive a 1µg ACTH stimulation test | Drug: synacthen<br>* 1 µg synacthen in the vein<br>* Other names: ACTH;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum cortisol-peak 30 min after ACTH-stimulation |  | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum DHEA-peak 30 min. after ACTH-stimulation,DHEA-S, ACTH |  | 30 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
isolated ACTH deficiency, Hashimoto disease, Hashimoto thyroiditis, autoimmune thyroiditis
Getting SMART for Pediatric Epilepsy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effect of melatonin for improving sleep in pediatric epilepsy.

Detailed Description
-----------------
Sleep disturbances are more prevalent in children with epilepsy whose sleep can be disrupted by seizures occurring during the night and/or during the day. Melatonin is a naturally occurring hormone produced in the pineal which regulates sleep-wake cycles and facilitates quality sleep. Therefore, the purpose of this study is to evaluate the effect of melatonin for improving sleep in pediatric epilepsy.

Official Title
-----------------
Getting SMART for Pediatric Epilepsy (Sleep, Melatonin, and Research Trial, SMART)

Conditions
-----------------
Epilepsy in Children

Intervention / Treatment
-----------------
* Drug: Melatonin
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Children aged between 1 and 18 years with a confirmed diagnosis of epilepsy and with sleep problems Exclusion Criteria: Children who are bedridden with limited mobility Children with liver or kidney dysfunction Children on medication for sleep or mood problems within 4 weeks before the baseline clinic visit Adolescent girls who are pregnant or breastfeeding Adolescent girls who have sexual activities but cannot take effective contraceptive measures during the trial

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum 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: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Melatonin<br>Melatonin | Drug: Melatonin<br>* Melatonin 2 mg daily for 4 weeks<br>* Other names: Melatonin supplement;|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* Placebo daily for 4 weeks<br>* Other names: Starch pill;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep quality | Sleep quality as assessed by actigraphy | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Behavioral profile | T scores as assessed by Child Behavior Checklist. A T score has a mean of 50 and standard deviation of 10, with higher scores representing more behavioral problems. | 4 weeks |
Evaluation of Patients With Idiopathic Pulmonary Fibrosis (IPF) Through an IPF Registry

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to create a database of demographics and samples in idiopathic pulmonary fibrosis.

Official Title
-----------------
Prospective Evaluation of Patients With Idiopathic Pulmonary Fibrosis Through an IPF Registry

Conditions
-----------------
Idiopathic Pulmonary Fibrosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Male or Female greater or equal to age 18. Referral by physician with the diagnosis of IPF, or interstitial lung disease (IPF considered likely). Exclusion Criteria (a) Unwilling or unable to give written informed consent.
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 |
| --- | --- | --- |
| Determine cellular and molecular determinants of IPF | An IPF Registry is being established to assemble sufficient patients with IPF (especially in its earliest stage) for phase I therapeutic protocols. The Registry will incorporate demographic and clinical data for natural history studies; second, research data on physiology, high-resolution CT scan, questionnaires, and blood samples for blood banking to be collected every 6 months for prospective studies on pathophysiology; and third, response to standard therapies will be monitored to determine cellular and molecular relationships to clinical outcome and predictors of survival. This is done in order to better determine cellular and molecular determinants of IPF. This cohort will be large enough to commence a separate phase I protocol with molecular strategies of intervention. | Long-Term |
Safety Study of Nebivolol for COPD Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate the safety and effectiveness of the study drug Nebivolol, in people who suffer with high blood pressure with Chronic Obstructive Pulmonary Disease (COPD).

Detailed Description
-----------------
The study would be a randomized, placebo-controlled trial of 60 hypertensive patients with documented COPD greater than age 40.

Official Title
-----------------
Nebivolol in Chronic Obstructive Pulmonary Disease

Conditions
-----------------
High Blood Pressure

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: Nebivolol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of high blood pressure and chronic obstructive pulmonary disease (COPD) Exclusion Criteria: Asthma; Heart failur; End stage kidney disease; acute myocardial infarction,unstable angina, stroke or TIA within the past year; Females who are pregnant, lactating or women of childbearing potential who are not using approved method of contraception.

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nebivolol<br>Group A will be given Nebivolol 5 to 10mg per day | Drug: Nebivolol<br>* 5 to 10mg per day<br>* Other names: bystolic;|
| Placebo Comparator: Placebo<br>Group B will be given Placebo. | Drug: Placebo<br>* The placebo looks like the study drug but it does not contain active ingredients.<br>* Other names: Placebo is a sugar pill.;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to assess blood pressure control | blood pressure control will be assessed per collection of research data at protocol visits. | baseline to 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to assess pulmonary function tests | pulmonary function tests will be assessed at protocol visits | baseline to 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Obstructive Pulmonary Disease
Impact of Exenatide on Sleep Duration

Study Overview
=================
Brief Summary
-----------------
This study investigates the effect of exenatide, a FDA approved medication for the treatment of type 2 diabetes on sleep duration and quality. Individuals with type 2 diabetes will be studied before and during treatment with Exenatide. Enrolled individuals will be asked to come to the University of Chicago for 3-4 outpatient visits over the course of 3-4 months.

Official Title
-----------------
Impact of Exenatide on Sleep Duration and Quality in Type 2 Diabetes

Conditions
-----------------
Type 2 Diabetes

Intervention / Treatment
-----------------
* Drug: Exenatide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients taking diabetes medications other then insulin will be included, but changes to their medications may be made as deemed necessary by their physician. Patients on stable medications for chronic and co-morbid conditions (high blood pressure, high cholesterol, etc) will be eligible Exclusion Criteria: Patients with moderate or severe kidney disease and history of pancreatitis or patients on insulin will be excluded, as Exenatide use is contraindicated or risky in these conditions. Patients with unstable cardiac, neurological or psychiatric disease and women who are pregnant or trying to get pregnant will be excluded. Patients who have severe COPD, severe neuropathy or chronic pain, which could impair sleep, will be excluded. Shift workers will be also excluded.

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?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Exenatide|Exenatide is started for the treatment of type 2 diabetes as determined by the patients regular physician. The dose will be 5-10 micrograms twice daily which is the standard dose. The medication is given by self-administered subcutaneous injection. The medication may continue for the treatment of the type 2 diabetes after the study is completed after 3 months.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep duration and sleep efficiency | Sleep duration and efficiency will be measured using an activity monitor worn on the wrist. | at the end of 3 months of treatment with the medication |
Carboxytherapy for Periorbital Dark Circles

Study Overview
=================
Brief Summary
-----------------
the study evaluates carboxytherapy for the treatment of periorbital dark circles

Detailed Description
-----------------
two different concentrations of carboxytherapy administered to patients are compared regarding efficacy

Official Title
-----------------
Evaluation of the Use of Carboxytherapy in Periorbital Dark Circles

Conditions
-----------------
Periorbital Disorder

Intervention / Treatment
-----------------
* Other: Caboxy30
* Other: Caboxy60


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy individuals with dark circles Exclusion Criteria: infections, scarring, pregnancy, allergy, on treatment for the condition.

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Carboxy30<br>carboxy30 | Other: Caboxy30<br>* carboxy30 to periorbital dark halos<br>* Other names: Carboxy30;|
| Active Comparator: Carboxy60<br>carboxy60 | Other: Caboxy60<br>* carboxy60 to periorbital dark halos<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of Melanin index | change in melanin index of the dark circles | 6 weeks | 
| Improvement of erythema index | change in erythema index of the dark circles | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dark circles, carboxytherapy
StaphVAX Immunogenicity in Orthopedic Implant Patients

Study Overview
=================
Brief Summary
-----------------
S. aureus is the most common pathogen involved in prosthetic joint infection. StaphVAX® is a vaccine to prevent these infections, which conjugates the purified capsular polysaccharides of S. aureus to a carrier protein. It is currently being evaluated for future licensing. This study aims to demonstrate the safety and immunogenicity of a single dose of StaphVAX in patients who are candidates for knee or hip arthroplasty.

Official Title
-----------------
A Multicenter, Randomized, Placebo-Controlled, Double-Blinded Study to Evaluate Safety and Immunogenicity of StaphVAX®, a Bivalent Staphylococcus Aureus Glycoconjugate Vaccine, in Adult Patients Receiving an Orthopaedic Prosthetic Implant

Conditions
-----------------
Staphylococcal Infections, Joint Prosthesis

Intervention / Treatment
-----------------
* Biological: S. aureus Type 5 & 8 Capsular Polysaccharide Conjugate
* Biological: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18 years or older candidate for knee or hip replacement expectation of protocol compliance negative pregnancy test, where appropriate Exclusion Criteria: known S. aureus infection in the prior 3 months infection in the prior 2 weeks Known HIV infection immunomodulatory drugs Malignancy (other than basal cell or squamous cell carcinoma, carcinoma in situ of the cervix, or early stage prostate cancer) Hypersensitivity to components of StaphVAX

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

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

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: StaphVAX<br> | Biological: S. aureus Type 5 & 8 Capsular Polysaccharide Conjugate<br>* single dose of vaccine containing 100 mcg of each serotype conjugate<br>|
| Placebo Comparator: Placebo<br> | Biological: placebo<br>* single dose of placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serotype-specific antibody concentrations |  | 6 weeks after dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serotype-specific antibody concentrations |  | several other time points after dose, up to 365 days | 
| safety: adverse events |  | 0-365 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vaccine, Staphylococcus aureus vaccine
Flexibility, Range of Motion and Strength Among Patients With Differing Response to the Scapular and Humeral Assistance Tests

Study Overview
=================
Brief Summary
-----------------
Shoulder pain may result from abnormal arm or shoulder blade (scapular) movement. These abnormal movements may result from a variety of flexibilty, motion or strength impairments. Therefore identifying any abnormal arm or scapular movement, as well as any impairments that are associated with them can help clinicians plan a proper management strategy for patients presenting with shoulder disorders. Our hypothesis is that specific impairments will be associated with abnormal arm movement, while other impairments will be associated with abnormal scapular movement among patients with shoulder pain.

Conditions
-----------------
Shoulder Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 years or older, main complaint of shoulder pain, ability to elevate arm in the scapular plane to at least 135 degrees, pain during scapular plane elevation, can read Hebrew. Exclusion Criteria: Signs or symptoms suggesting cervical spine origin, previous fracture around shoulder complex, traumatic onset of shoulder pain, Fibromyalgia, Rheumatiod arthritis, previous shoulder surgery, loss of 50% or more of passive range of motion in 2 or more planes of motion, positive lag signs, positive apprehension test, pregnancy.

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

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 |
| --- | --- | --- |
| Shoulder internal rotation range of motion | Measurement of supine glenohumeral internal rotation range of motion. | Baseline | 
| Posterior capsule flexibility | Measurement of sidelying glenohumeral horizontal adduction | Baseline | 
| Pectoralis minor resting length | Distance from coracoid process to 4th rib attachment onto sternum | Baseline | 
| Scapular dyskinesis | Visual assessment and classification of scapular movement pattern | Baseline | 
| Scapular upward rotation range of motion | Measured by the use of an inclinometer placed on top of scapular spine during various degrees of glenohumeral elevation angles. | Baseline | 
| Shoulder elevation torque | Measured with a hand-held dynamometer | Baseline | 
| Shoulder external rotator torque | Measured with a hand-held dynamometer | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Shoulder pain, Scapular dyskinesia, Physical examination