linjc16/ctgov huggingface dataset:
Study to Investigate the Safety, Tolerability and Pharmacokinetics of AZD1386

Study Overview
=================
Brief Summary
-----------------
The study is being performed in order to learn more about the safety and tolerability of AZD1386. AZD1386 is primary intended for treatment of chronic pain.

Official Title
-----------------
A Phase I, Randomised, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD1386 in Healthy Caucasian Young and Elderly Subjects After Oral Multiple Doses.

Conditions
-----------------
Chronic Pain

Intervention / Treatment
-----------------
* Drug: AZD1386
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Caucasians, males or females aged ≥20 and ≤ 45 years or between 65 80 years. Female subjects must be surgically sterile or post-menopausal for at least 12 months prior to the enrolment visit. Body Mass Index (BMI) of ≥18 to ≤ 30 kg/m2 and weight of ≥50 to ≤100 kg Clinically normal physical findings including heart rate > 45 bpm and laboratory values and normal resting ECG Exclusion Criteria: History of somatic or psychiatric disease/condition, which may interfere with the objectives of the study. History of severe allergy/hypersensitivity or symptoms/signs of ongoing allergy/hypersensitivity. Subjects with a high decrease in blood pressure within 5 minutes when going from a supine to standing position.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AZD1386<br>7 groups receiving a specified volume of the active component AZD1386 at different points of time. | Drug: AZD1386<br>* Oral admin. of doses at 11 days through a 12 days period. Cmax = 16 mikromol/L and AUCmax = 98 mikromol*h/L<br>|
| Placebo Comparator: Placebo<br>7 groups receiving a specified volume of placebo at different points of time | Drug: Placebo<br>* Oral admin. of doses at 11 days through a 12 days period.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety AEs and vital signs |  | During the whole study | 
| ECG-recordings |  | ECGs (5 minutes) Days 1 and 12. 2 ECGs (5 minutes) Days 3, 6 and 10. 1 ECG (5 minutes) Days 2 and 13. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK |  | Days 1, 5 and 12, 12 times each day. Days 4, 6, 8, 10 and 14, once. Days 2, 3, 7, 9, 11 and 13 twice. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MAD, Multiple ascending dose, Chronic pain, pain
Serum Squamous Cell Carcinoma Antigen Level and Tumor Volume in Head and Neck Cancer

Study Overview
=================
Brief Summary
-----------------
Correlation between serum squamous cell carcinoma antigen level and tumor volume in Head and Neck Cancer is to determine a correlation between level of serum squamous cell carcinoma antigen and tumor volume in Head and Neck Caner measured by cross-sectional imaging.

Detailed Description
-----------------
The study is a cross-sectional study. A single measurement of serum squamous cell carcinoma antigen level is performed in the eligible Head and Neck squamous cell carcinoma patients. The study tool measuring serum squamous cell carcinoma antigen level is ARCHITECT SCC (Abbott). The gross tumor volume in the cross sectional imaging obtained within 2 weeks of each patient is calculated with the typical ellipsoid formula. Correlation between both parameters will be determined.

Official Title
-----------------
Correlation Between Serum Squamous Cell Carcinoma Antigen Level and Tumor Volume in Head and Neck Cancer

Conditions
-----------------
Head and Neck Cancer

Intervention / Treatment
-----------------
* Other: Non-interventional study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically proven squamous cell carcinoma in Head and Neck Getting a cross-sectional imaging of Head and Neck within 2 weeks of collecting serum squamous cell carcinoma antigen Exclusion Criteria: Metastatic disease Accompanied Non-Head and Neck squamous cell carcinoma Nasopharyngeal, thyroid, salivary, nose and paranasal sinus carcinoma Skin disease: eczema, erythrodermic epidermitis, pemphigus, and psoriasis Pulmonary disease: tuberculosis, adult respiratory distress syndrome, pulmonary infiltration with eosinophilia, sarcoidosis, and bronchogenic cyst Renal failure Using antihistamine eye drops

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 |
| --- | --- |
| Head and Neck squamous cell carcinoma<br>A single measurement of serum squamous cell carcinoma antigen level is performed in the eligible Head and Neck squamous cell carcinoma patients. The study tool measuring serum squamous cell carcinoma antigen level is ARCHITECT SCC (Abbott). The gross tumor volume in the cross sectional imaging obtained within 2 weeks of each patient is calculated with the typical ellipsoid formula. | Other: Non-interventional study<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between serum squamous cell carcinoma antigen and tumor volume |  | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
serum squamous cell carcinoma antigen, tumor volume, Head and Neck Cancer
A Pilot Study to Determine the Safety of Campath-1H (Anti-CD52 Antibody) Therapy in Newly Diagnosed Subjects With Type 1 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
The rationale for the study is to determine if Campath-1H can be used in patients recently diagnosed with type I DM, to induce a state of immunological unresponsiveness such that subjects can safely preserve beta cell mass and eliminate or lower insulin requirements, preserving excellent metabolic control.

Official Title
-----------------
A Pilot Study to Determine the Safety of Campath-1H (Anti-CD52 Antibody) Therapy in Newly Diagnosed Subjects With Type 1 Diabetes Mellitus

Conditions
-----------------
New Onset Type 1 Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: Campath 1H® (Alemtuzumab)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult subjects ages 18-35, with new onset type 1 diabetes mellitus (within 2-12 weeks of diagnosis), one or more islet autoantibody to GAD, IA2, IAA or islet cell cytoplasmic antibody (ICA) within 2 weeks of diabetes diagnosis. Exclusion Criteria: Subjects under 18 years of age or over 35 years of age. Subjects who have previously received an organ transplant. Subjects who are currently receiving systemic corticosteroids for other medical diseases in which the physician feels discontinuation of corticosteroids is contraindicated. Subjects with a history of other medical condition(s) known to affect blood glucose values (i.e., Cushing's disease, acromegaly). Subjects with a history of other chronic systemic inflammatory or autoimmune disease or other severe medical condition. (A history of treated hypothyroidism with documentation of normal serum thyroid hormone levels will not be exclusionary.) Patients with a history of hepatitis B, hepatitis C, or HIV. PPD positive at the time of evaluation. Thrombocytopenia or neutropenia. Individuals will be considered to have thrombocytopenia if they have a platelet count <100,000 platelets/mm2 or <3,000 WBC/ml. Subjects with a history of renal, pulmonary, or cardiac failure Subjects with severe systemic infections. Only those subjects who have completed treatment and have shown a complete clinical resolution will be considered eligible for the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Campath 1H® (Alemtuzumab)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to determine if Campath-1H can be used in patients recently diagnosed with type I DM |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to determine if Campath-1H can eliminate or lower insulin requirements |  |  |
Evaluation of Novel Risk Factors and Clinical Outcomes of Acute Myocardial Infarction

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to investigate the potential novel risk factors for acute myocardial infarction. Predictors of poor outcomes will be also evaluated.

Official Title
-----------------
A Multicenter Prospective Observational Study to Evaluate the Novel Risk Factors and Clinical Outcomes of Acute Myocardial Infarction (AMI)

Conditions
-----------------
Coronary Artery Disease, Percutaneous Coronary Intervention, Acute Myocardial Infarction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Less than 12 hours after the onset of myocardial infarction symptoms Myocardial necrosis, as evidenced by increased Creatine Kinase Isoenzyme (CK-MB) or troponin levels Exclusion Criteria: Age under 18 years-old

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 |
| --- | --- | --- |
| Major adverse cardiovascular events (MACE) | Composite of angina pectoris, reinfarction, unplanned rehospitalization, stent thrombosis, incidence of cardiac death in the duration of follow-up | maximum 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay | The length of in-hospital stay is counted as a secondary outcome | in the phase of hospital stay, maximum 30 days | 
| New-onset diabetes | New-onset diabetes are defined as newly-diagnosed type 2 diabetes mellitus | the duration of follow-up, maximum 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Myocardial Infarction, Cardiovascular Diseases, Heart Diseases, Infarction, Diabetes
Rasburicase for the Treatment/Prevention of Hyperuricemia in Adult Patients With Relapsing Aggressive Non Hodgkin's Lymphoma

Study Overview
=================
Brief Summary
-----------------
The primary objective was to evaluate the efficacy of rasburicase in terms of prevention and treatment of hyperuricemia related to Tumor Lysis Syndrome (TLS) in 2 populations of adult patients, previously treated or not with urate oxidase, with relapsing aggressive non-Hodgkin's lymphoma (NHL) and at risk of TLS, presenting with hyperuricemia and/or bulky disease at diagnostic of relapse. The secondary objectives were to : evaluate the efficacy of rasburicase in terms of renal protection, evaluate the safety of rasburicase in the two cohorts of patients, correlate efficacy and safety results with antibodies generation/level.

Official Title
-----------------
Study of Efficacy and Safety of Rasburicase for the Treatment/Prevention of Hyperuricemia Related to Tumor Lysis Syndrome in Adult Patients With Relapsing Aggressive Non Hodgkin's Lymphoma, Previously Treated or Not With Urate Oxidase Presenting With Hyperuricemia and/or Bulky Disease

Conditions
-----------------
Hyperuricemia

Intervention / Treatment
-----------------
* Drug: Rasburicase (SR29142)


Participation Criteria
=================
Eligibility Criteria
-----------------
Patients with histologically proven aggressive Non Hodgkin's Lymphoma

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
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Rasburicase (SR29142)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| responder rate (based on normalization of uric acid levels) |  |  |
Pharmacokinetic Study to Determine Time to Steady-state

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to confirm how long (i.e., how many days) it takes to reach steady-state when testosterone undecanoate is administered twice daily.

Detailed Description
-----------------
Serum testosterone levels will be obtained in hypogonadal (serum testosterone <300 ng/dL) males receiving testosterone undecanoate capsules administered twice daily. Serum samples will be obtained consecutively in the morning on several days during one month of open-label treatment to confirm the time at which steady-state is reached.

Official Title
-----------------
Pharmacokinetic Study to Determine Time to Steady-state of an Oral Testosterone Undecanoate Formulation in Hypogonadal Men.

Conditions
-----------------
Male Hypogonadism, Primary Hypogonadism, Secondary Hypogonadism

Intervention / Treatment
-----------------
* Drug: Testosterone undecanoate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male, age 18-75 Morning serum testosterone (T) <300 ng/dL on two occasions Naive to androgen-replacement therapy or willing to wash-out from current T therapy Exclusion Criteria: Significant intercurrent disease Abnormal prostate digital rectal exam, elevated PSA, AUA symptom score >15 or history of prostate cancer. Serum transaminases >2 times upper limit of normal Serum bilirubin >2.0 mg/dL Hematocrit <35% or >50% BMI >36 Untreated, obstructive sleep apnea.

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

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

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: Testosterone Undecanoate<br>Oral testosterone undecanoate, 200 mg testosterone (T) as TU, twice daily for 28 days. | Drug: Testosterone undecanoate<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum T Concentration at Steady State | Serum T at steady state by evaluating the day-to-day changes in pre-dose concentrations on Days 1, 3, 5, 6, and 7 of treatment. | pre-dose on Days 1, 3, 5, 6, and 7 | 
| Serum T Concentration at Steady-State | Serum T at steady-state by evaluating the day-to-day changes in pre-dose concentrations on Days 10, 14, 17, 21, 24, 27, and 28 of treatment. | pre-dose on Days 10, 14, 17, 21, 24, 27, and 28 |
Inhaler Technique Training

Study Overview
=================
Brief Summary
-----------------
The evidence for poor inhaler technique is both well established and observed worldwide. What is unclear from the evidence is why individuals demonstrate poor technique, despite the majority admitting to having previously had instruction on inhaler technique. The primary research question is 'Will there be a difference between post education inhaler technique scores when comparing structured education against informal education?' To try and establish why individuals use inhalers incorrectly a semi structured interview is proposed

Official Title
-----------------
Evaluating the Efficacy of 2 Different Educational Strategies for Improving and Maintaining Inhaler Technique

Conditions
-----------------
Asthma Chronic, Obstructive Pulmonary Disease

Intervention / Treatment
-----------------
* Behavioral: Assessment of inhaler technique pre and 6 weeks post training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Inclusion criteria will be anybody whose regular treatment requires inhaled medication. They will be included regardless of age, disease, inhaler device used or cognition. Exclusion Criteria: The only exclusion criteria will be if a willing participant is not on an inhaler of any type.

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 90 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard care<br>This arm will receive standard care which involves informal education on how to use metered dose inhalers | |
| Active Comparator: Structured education<br>This arm will receive structured education on the use of inhalers. At 6 weeks post education inhaler technique will be re-assessed. Participants who fail to achieve a set level of competence may be chosen for semi structured interview. | Behavioral: Assessment of inhaler technique pre and 6 weeks post training<br>* Assessment of inhaler technique on day one. Education package and training on inhaler use at week 2. Final assessment to establish maintenance of inhaler competence at week 8<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inhaler technique scores will be compared at 6 weeks post inhaler technique education. The proportion achieving proficiency will be compared between those recieving usual care and those recieving structured care. |  | 6 weeks per cohort |
Boston Birth Cohort Study

Study Overview
=================
Brief Summary
-----------------
Early life exposures may lead to adverse effects on health in later life. The Boston birth Cohort study is designed to study a broad array of early life factors and their effects on maternal and child health outcomes.

Detailed Description
-----------------
Any woman admitted to the Labor and Delivery floor at the Boston Medical Center (BMC) who delivers a singleton live infant and meets our case (gestational age <37 weeks or birthweight <2,500 grams) or control (full term birth with birthweight >2,500 grams) criteria will be eligible. Postnatal follow-up of enrolled mother-child pair is conducted from birth to age 21 years. The Boston Birth Cohort has high-quality biospecimen collection, and comprehensive epidemiological, clinical, and environmental exposure data via standardized questionnaire interview, measurements, and review of the electronic medical records.

Official Title
-----------------
Early Life Origins of Pediatric and Adult Diseases: Boston Birth Cohort Study

Conditions
-----------------
Maternal Health, Child Health, Pregnancy Complications, Birth Outcome, Adverse

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mothers who deliver singleton live births at Boston Medical Center are eligible for the study. Exclusion Criteria: pregnancies that are a result of in vitro fertilization or that involve multiple gestations, fetal chromosomal abnormalities or major birth defects.

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 21 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 |
| --- | --- | --- |
| Pregnancy complications | Multiple pregnancy complications are examined including gestational diabetes, hypertensive disorders of pregnancy. | At birth | 
| Birth outcomes - preterm birth | Birth outcomes are examined - preterm birth. | At birth | 
| Birth outcomes - birthweight | Birth outcomes are examined - birthweight. | At birth | 
| Child health outcomes | Multiple child health outcomes are examined including food allergy, asthma, child's overweight or obesity, blood pressure, and child neuro-developmental outcomes. | From birth to 21 years | 
| Maternal health outcomes | Multiple maternal health outcomes are measured including blood pressure, weight, height, physician diagnosis. | After delivery to 21 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Boston Birth Cohort, Early life origins of pediatric and adult disease, Gene environment interaction, Health across life course and generations