linjc16/ctgov huggingface dataset:
Study of Growth Hormone and Bone in Obesity

Study Overview
=================
Brief Summary
-----------------
Obesity is an important risk factor for osteoporosis and fractures. With the growing prevalence of obesity in the U.S., understanding the pathophysiology of bone loss in this population is of importance to public health. Growth hormone (GH) is a critical mediator of bone homeostasis and is markedly reduced in obesity. Our preliminary data suggest an important role for the GH/insulin-like growth factor 1 (IGF-1) system in the pathogenesis of bone loss in obesity. The development of novel imaging techniques provides an opportunity to investigate the effects of GH on skeletal structure and strength, which will provide insights into the pathogenesis of obesity related bone loss. Understanding the pathophysiology of bone loss in obesity may help identify new treatment targets for this important complication. The investigator hypothesizes that low-dose GH administration for 18 months will improve skeletal health.

Official Title
-----------------
Skeletal Physiology Dysregulation in Obesity: The Role of Growth Hormone

Conditions
-----------------
Obesity, Osteopenia

Intervention / Treatment
-----------------
* Drug: Growth hormone
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages 18-65 and generally healthy BMI ≥ 25 kg/m2 Bone mineral density (BMD) T score ≤ -1.0 and > -2.5 (as measured by DXA) Exclusion Criteria: For women: amenorrhea for 3 months, pregnancy or breastfeeding, polycystic ovary syndrome History of diabetes mellitus, cancer or other serious chronic disease Use of osteoporosis medications Anemia

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Growth Hormone<br>Growth Hormone is Genotropin, provided by Pfizer Inc. It is self administered daily for 18 months using a 5 mg injection pen device. Dose will be titrated based on IGF-1 levels. | Drug: Growth hormone<br> <br> * Other names: Genotropin (Pfizer Inc.);|
| Placebo Comparator: Placebo<br>Placebo will be provided by Pfizer Inc. It will appear identical to active growth hormone and will be administered in the same manner. | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone Mineral Density | Change in BMD over 18 months in the GH vs placebo group | baseline and 18 months |
Location of Lower Limb Cutaneous Melanomas as a Prognostic Factor.

Study Overview
=================
Brief Summary
-----------------
Observational study to know the relevance of specific anatomical location of cutaneous melanoma on lower limbs.

Detailed Description
-----------------
Ambispective (retrospective and prospective) observational register of patients with cutaneous melanoma on lower limbs are grouped in 1) proximal (thigh), 2) medium (leg), and 3) distal (ankle and foot) location. Analysis of melanoma-specific overall and disease-free survival will be made, as well as multivariant analysis for prognostic variables including anatomical location.

Official Title
-----------------
Lower Limb Cutaneous Melanoma: Observational Prognostic Study About Specific Location of the Primary Lesion.

Conditions
-----------------
Cutaneous Melanoma, Anatomical Pathological Condition

Intervention / Treatment
-----------------
* Other: Observational


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cutaneous melanoma on the lower limb Exclusion Criteria: Incomplete staging
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Location on lower limb<br>Proximal (thigh) Medium (leg) Distal (ankle and foot) | Other: Observational<br>* Observational<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Melanoma-specific overall survival | Melanoma-specific overall survival | Ten years | 
| Melanoma-specific disease-free survival | Melanoma-specific disease-free survival | Ten years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cutaneous melanoma, lower limb, prognostic
Recurrent Carotid Stenosis

Study Overview
=================
Brief Summary
-----------------
To determine whether recurrent stenosis following carotid endarterectomy could be reduced by pre- and post-operative oral administration of platelet-inhibiting drugs.

Detailed Description
-----------------
BACKGROUND: Following endarterectomy, platelets adhere and aggregate on the endarterectomized surface and release platelet-derived growth factor which induces smooth muscle cell migration and proliferation which may result in restenosis. Many patients had been treated with aspirin and dipyridamole, but not in a controlled trial. The Recurrent Carotid Stenosis Study established whether antiplatelet therapy was beneficial in the prevention of recurrent carotid artery stenosis. DESIGN NARRATIVE: Randomized, double-blind. Eighty-three patients (90 endarterectomies) were randomly assigned to receive 325 mg of oral aspirin plus 75 mg of dipyridamole, beginning 12 hours pre-operatively, followed by a second dose administered within eight hours after the operation, and given three times daily thereafter for one year. Eighty patients (85 endarterectomies) received placebo. After the adequacy of the surgical procedure was confirmed by intraoperative angiography, restenosis at the endarterectomy sites was evaluated using serial duplex ultrasound before hospital discharge and at three-month intervals postoperatively for one year.

Conditions
-----------------
Cardiovascular Diseases, Carotid Stenosis, Cerebrovascular Disorders, Heart Diseases, Vascular Diseases

Intervention / Treatment
-----------------
* Drug: aspirin
* Drug: dipyridamole


Participation Criteria
=================
Eligibility Criteria
-----------------
Men and women who had recently undergone carotid endarterectomy.

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: Prevention
Allocation: Randomized
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: aspirin|nan|
|Drug: dipyridamole|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Safety and Pharmacokinetic Comparison of Co-administration and a Combination Drug of Rosuvastatin and Olmesartan in Healthy Male Volunteers

Study Overview
=================
Brief Summary
-----------------
This study investigates safety and pharmacokinetic comparison of DWJ1276, a combination drug of Rosuvastatin and Olmesartan (test formulation), and co-administration of Rosuvastatin and Olmesartan (reference formulation) for single dose in healthy volunteers

Official Title
-----------------
A Randomized, Open Label, Single-Dose, 2-Way Cross-over Clinical Trial to Compare the Safety and Pharmacokinetic Characteristics of Combination of Rosuvastatin and CS-866 and DWJ1276 in Healthy Male Volunteers

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Test formulation
* Drug: Reference formulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male volunteers between the ages of 20 and 50 and within 20% of their ideal body weight, without congenital abnormality or chronic disease Exclusion Criteria: History of cardiovascular, pulmonary, renal, endogenous, gastrointestinal, hematologic, neurologic or hemorrhagic disease; Clinically significant findings on routine laboratory (hematology, serum chemistry and urinalysis) or ECG tests; Use of prescription drugs in the 14 days immediately prior to starting the study that had the potential to interact with the study medication; Use of any substance that could induce or inhibit drug metabolism enzymes

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test and reference formulations<br>Test formulation and reference formulation given orally 7 days apart in a fasted state | Drug: Test formulation<br>* Single administration of a combination tablet of Rosuvastatin 20mg and Olmesartan 40mg<br>Drug: Reference formulation<br>* Co-administration of Rosuvastatin 20mg tablet and Olmesartan 40mg tablet<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Profile of Pharmacokinetics | Cmax, Area Under Curve (0 to last sampling time) | 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72 hours post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Profile of Pharmacokinetics | Tmax, Area Under Curve (0 to infinity), T_1/2 | 0, 0.33, 0.67, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72 hours post-dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pharmacokinetics
Dose-Response of Adenosine for Perioperative Pain

Study Overview
=================
Brief Summary
-----------------
Adenosine A1 and A2 receptors are widely distributed in the brain and spinal cord and represent a non-opiate target for pain management. Activated spinal A1 receptors inhibit sensory transmission by inhibiting the slow ventral root potential, which is the C-fiber-evoked excitatory response associated with nociception. Adenosine may inhibit intrinsic neurons through an increase in K+ conductance and presynaptic inhibition of sensory nerve terminals to inhibit the release of substance P and perhaps glutamate. Although adenosine A3 receptors are not found in the nervous system, adenosine is also known to have anti-inflammatory properties that may contribute to pain relief in the peripheral setting of inflammation.

Official Title
-----------------
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Escalating Dose-Response Trial of Intravenous Adenosine for Perioperative Analgesia in Females Undergoing Abdominal Hysterectomy or Myomectomy

Conditions
-----------------
Perioperative Pain

Intervention / Treatment
-----------------
* Drug: adenosine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female gender; age 18 to 65 years; American Society of Anesthesiology (ASA) physical classification I to III; scheduled for non-emergent abdominal hysterectomy (with or without salpingo-oophorectomy) or myomectomy under general anesthesia; Exclusion Criteria: ASA physical classification of IV or V; documented history of cardiovascular disease including coronary artery disease, uncontrolled hypertension, aortic stenosis, congestive heart failure, cardiac arrhythmias or conduction defects greater that first degree atrioventricular (AV) block, sinoatrial (SA) or AV node disease including sick sinus syndrome or symptomatic bradycardia, presence of devices including pacemakers or internal defibrillators, or history of symptoms consistent with any of the aforementioned conditions (e.g., angina, dyspnea on exertion, paroxysmal nocturnal dyspnea); history of asthma, bronchospastic lung disease, or hyper-reactive airway disease; history of gout;

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose-response |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| efficacy |  |  |
Metabolic Profile and Anthropometric Changes in Schizophrenia

Study Overview
=================
Brief Summary
-----------------
No clinical differences will be found between the three antipsychotics under study - olanzapine, risperidone and haloperidol - on the patients' metabolic profile and weight. 

Detailed Description
-----------------
we aimed to study the effects of antipsychotics, olanzapine, risperidone and haloperidol on development of metabolic syndrome in a drug naïve population suffering from first episode schizophrenia and compared it with a matched healthy control group. We also aimed to examine the prevalence of metabolic syndrome as defined by the two most widely accepted definitions, the ATP IIIA and the IDF.

Official Title
-----------------
Metabolic Profile and Anthropometric Changes in Schizophrenia

Conditions
-----------------
Metabolic Syndrome, Diabetes, Obesity

Intervention / Treatment
-----------------
* Drug: Olanzapine
* Drug: Risperidone
* Drug: Haloperidol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 18-40 years Diagnosis of schizophrenia Drug naive on admission Exclusion Criteria: Other psychiatric co-morbidity History of severe physical illness Alcohol and substance abuse or dependence History of pre-existing diabetes or hypertension Family history of hypertension or diabetes

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Olanzapine | Drug: Olanzapine<br>* Olanzapine in dose range of 10-20mg<br>|
| Active Comparator: 2<br>Risperidone | Drug: Risperidone<br>* Risperidone 1-6mg<br>|
| Active Comparator: 3<br>haloperidol | Drug: Haloperidol<br>* Haloperidol 10-20mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study of metabolic profile |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study of obesity and diabetes |  | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Metabolic syndrome, Obesity, Diabetes
The Metabolomics of Anaphylaxis

Study Overview
=================
Brief Summary
-----------------
Metabolomics is the study of metabolic pathways and the unique biochemical molecules which result from the regulatory response to physiological stressors, disease processes, or drug therapy. By measuring changes in metabolite concentrations, the range of biochemical effects and therapeutic intervention can be determined. Aspirin exacerbated respiratory disease (AERD) is a chronic inflammatory disease characterized by chronic rhinosinusitis, nasal polyposis, asthma, and airway reactivity to aspirin and/or other nonsteroidal anti-inflammatory drugs (NSAIDs). This reaction to aspirin during challenge/desensitization is equivalent to an allergic drug reaction however we are able to evaluate these specific reactions in a controlled, clinical environment. This population of patients undergoing aspirin desensitization is ideal for studying metabolomics as serial blood sampling can be performed in patients before, during a reaction, and after aspirin desensitization, thereby allowing each patient to serve as his or her own biological control. The investigator hopes that this study of metabolomics will allow for better methods of identifying anaphylaxis in the future.

Official Title
-----------------
The Metabolomics of Anaphylaxis

Conditions
-----------------
Patients With AERD Undergoing Aspirin Desensitization

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients ages 18-75 with a history of aspirin anaphylaxis or a history of hypersensitivity reaction to aspirin and referred for a clinically indicated outpatient or inpatient aspirin desensitization procedure for AERD. Exclusion Criteria: Pregnancy/breastfeeding, possibility of poor compliance, unwilling to undergo aspirin desensitization.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Aspirin desensitization<br>This group of patients has AERD (aspirin exacerbated respiratory disease) and is undergoing aspirin desensitization. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in metabolic profile of blood serum metabolites from Baseline to 1 week post-desensitization | Metabolic profiling will be done on specific blood serum metabolites including lipid mediators, amino acids, and leukotrienes. | before start of aspirin desensitization, 2 hours into desensitization, at time of reaction(s) - an expected average of 6 hours into desensitization, 1 week post-desensitization |
An Observational Study to Investigate the Role of B Cells in Multiple Sclerosis

Study Overview
=================
Brief Summary
-----------------
Multiple sclerosis (MS) typically afflict young people in their twenties, when they start a career and establish a family. The disease thus imposes a severe impact on quality of life and heavy economic burdens on society. Critical barriers to progress in the field are the lack of knowledge of relevant immune cell subsets driving the pathology and the targets of the immune response within the central nervous system. In this project, we will test the hypothesis that a subgroup of MS patients is defined by a genetically determined B cell response against specific antigenic epitopes. The hypothesis is based on our recent, pioneering results showing that approximately half of MS patients have a restricted population of B cells in the cerebrospinal fluid defined by polymorphisms in the constant heavy-chain of the immunoglobulin B cell receptor, the G1m1 allotype. Here, we aim to characterize the G1m1 B cells, to disentangle the genetic basis of the B cell response, and to identify the molecular targets.

Official Title
-----------------
Decoding the B Cell Response in Multiple Sclerosis

Conditions
-----------------
Multiple Sclerosis

Intervention / Treatment
-----------------
* Other: Analysis of B cells


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Symptoms and brain MRI scans strongly suggestive of multiple sclerosis according to the 2017 McDonald revisions Intrathecal immunoglobulin G synthesis Age > 18 years Exclusion Criteria: Treatment with immunomodulatory drugs

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 |
| --- | --- |
| Multiple sclerosis<br>Patients with relapsing-remitting multiple sclerosis | Other: Analysis of B cells<br>* B cells from blood and cerebrospinal fluid will be analyzed using RNA-seq<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The transcriptome of B cells from blood and cerebrospinal fluid |  | 1 day (subject inclusion) | 
| The immunglobulin receptors of B cells from blood and cerebrospinal fluid |  | 1 day (subject inclusion) |
Healthy Human Control Blood Collection for Validation of Biomarker Assay

Study Overview
=================
Brief Summary
-----------------
Human blood will be collected to serve as control in validating clinical studies studying the detection and levels of circulating tumor cells and microvesicles in cancer patients. Targeted population is cancer-free 18-60 year old men and women. Volunteer selection will rely upon a short health questionnaire. About 20 mL blood will be collected from volunteers up to 20 different timepoints. The Procedure involves minimal risk of harm (eg discomfort, bruising) to the volunteer.

Official Title
-----------------
Human Blood Collection to Serve as Negative Control for Validation of Circulating Tumor Cell Assay

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Other: Blood collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age range: 18-60 years old Gender: Male and Female Exclusion Criteria: No previously diagnosed malignancy Age: It is important to obtain a healthy, cancer-free volunteer population to serve as negative controls for this detection assay.

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Blood collection|Blood Collection|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood count |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cancer-free 18-60 year old men and women