linjc16/ctgov huggingface dataset:
Vitamin D Insufficiency and Deficiency in Chronic Kidney Disease (CKD) Patients in Singapore

Study Overview
=================
Brief Summary
-----------------
Vitamin D insufficiency and deficiency is common in chronic kidney disease (CKD) patients and is associated with elevated parathyroid hormone (PTH) concentration and mineral and bone disorder (MBD). There is also increasing evidence to show that these abnormalities increase cardiovascular morbidity and mortality in CKD patients. There is a need for early identification of vitamin D insufficiency/deficiency in CKD patients to prevent its long-term complications. However, the vitamin D status of CKD patients in Singapore has not been well described. The purpose of this study is to assess the vitamin D status of predialysis CKD patients in a tertiary academic teaching hospital in Singapore, and its association with parameters for MBD. Predialysis patients from the outpatient renal clinic at the National University Hospital (NUH) will be recruited into this study. Blood samples from the patients will be collected after an overnight fast to determine their serum 25(OH)D, creatinine, phosphorus, calcium, albumin and i-PTH concentrations. These parameters will be compared among patients in various stages of CKD.

Official Title
-----------------
Prevalence of Vitamin D Insufficiency and Deficiency in Chronic Kidney Disease Patients in Singapore

Conditions
-----------------
Stage 2-5 Chronic Kidney Disease, Predialysis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female 21 years of age or older CKD stage 2 to 5 (who are not on dialysis): CKD stage 2: eGFR 60-89ml/min/1.73m2, stage 3: eGFR 30-59ml/min/1.73m2, stage 4: eGFR 15-29 ml/min/1.73m2, stage 5 eGFR <15 ml/min/1.73m2) Not receiving over-the-counter or prescription vitamin D therapy On a stable dose of phosphate binder (if any) for at least 1 month prior to the study Exclusion Criteria: History of liver and chronic inflammatory diseases, primary hyperparathyroidism and malignancies Use of corticosteroids, anticonvulsants or vitamin D compounds Use of an investigational agent within 30 days of study entry

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- | --- |
| Chronic kidney disease<br>All patients with stage 2-5 (pre-dialysis) chronic kidney disease One-time blood draw (10 ml) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vitamin D 25(OH)D levels | Vitamin D levels are only measured at one time point i.e. at baseline | baseline |
Comparative Study of the Propagation of Uterine Electrical Activity (EHG) in Pregnant Women During Pregnancy and During Labour

Study Overview
=================
Brief Summary
-----------------
The original aspect of the methodology proposed for this study concerns the use of as many as 16 electrodes to study the propagation and coordination (or synchronization) of uterine contraction. Over the last two years, the Compiègne University of Technology and the University of Reykjavik (Iceland) teams have developed the tools required to obtain good quality signals during electrohysterography and have worked on filtering and mapping of uterine electrical activity derived from these signals.

Official Title
-----------------
Comparative Study of the Propagation of Uterine Electrical Activity (EHG) in Pregnant Women During Pregnancy and During Labour

Conditions
-----------------
Uterine Contraction, Pregnancy, Delivery, Obstetric

Intervention / Treatment
-----------------
* Device: Electrohysterography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: singleton pregnancy Exclusion Criteria: Minor patient twin pregnancy or more

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| pregnant women not in labour<br>from 24 weeks of gestation until term, provided that they are not in labour Electrohysterography | Device: Electrohysterography<br> <br> |
| women in labour<br>Electrohysterography | Device: Electrohysterography<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| parameter H2 | To demonstrate a difference of propagation of the electrical signal during a physiological contraction of pregnancy and uterine contraction during delivery. The parameter H2 (nonlinear correlation coefficient) will be used to measure propagation of the electrical signal. | H2 value measured at each contraction during 1 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
labour
Pre-flight Evaluation of Adult Patients With Cystic Fibrosis

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to investigate the relationship between hypoxemia achieved during Hypoxia Altitude Simulation test and sea level values of pulmonary function, arterial blood gases, pulse oximetry and cardiopulmonary exercise test variables. In addition, to study the effect of slow walk in a hypoxic environment, comparable to slow walking along the aisle.

Official Title
-----------------
Pre-flight Evaluation of Adult Patients With Cystic Fibrosis

Conditions
-----------------
Cystic Fibrosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cystic fibrosis > 16 years Sputum test negative for Burkholderia cepacia and/or methicillin resistant Staphylococcus aureus Exclusion Criteria: Ongoing infection

Ages Eligible for Study
-----------------
Minimum Age: 17 Years
Maximum Age: 80 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Blood gas response, Exercise, Gas exchange, Hypoxia altitude simulation test, Pulmonary function
Study of Rehabilitation Therapy on Patients After Acute Myocardial Infarction

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether exercise rehabilitation can reduce mortality, reinfarction or heart failure of patients after acute myocardial infarction.

Official Title
-----------------
Study of Rehabilitation Therapy on Patients After Acute Myocardial Infarction

Conditions
-----------------
Acute Myocardial Infarction

Intervention / Treatment
-----------------
* Behavioral: Exercise training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of ST-elevated myocardial infarction Heart function class I-II(killip classification) Agree to take cardiopulmonary exercise testing before discharge Signature of the informed consent document Exclusion Criteria: History of myocardial infarction Acute myocardial infarction with severe complications(such as pulmonary edema, severe cardiac arrhythmia or cardiogenic shock) Atrial fibrillation Other severe diseases, such as HIV infection, malignant tumor or chronic diseases of liver, kidney or pulmonary Not be capable of exercise training

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 74 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>exercise training group | Behavioral: Exercise training<br>* Exercise training<br>|
| No Intervention: 2<br>control group | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac mortality |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-fatal reinfarction, revascularization(PCI/CABG), ischemic stroke, unstable angina pectoris needs for hospitalization, severe heart failure needs for hospitalization |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ST-Elevated Myocardial Infarction, Exercise Training, Rehabilitation
Recombinant Human C1 Inhibitor for the Treatment of Acute Attacks in Patients With Hereditary Angioedema

Study Overview
=================
Brief Summary
-----------------
The purpose of this single-center study is to explore the efficacy, safety, tolerability and pharmacokinetics/pharmacodynamics of recombinant human C1 inhibitor in the treatment of acute attacks in patients with hereditary angioedema.

Official Title
-----------------
A Phase II Exploratory, Open-label Study of the Safety and Efficacy of Recombinant Human C1 Inhibitor for the Treatment of Acute Attacks in Patients With Hereditary Angioedema

Conditions
-----------------
Genetic Disorders

Intervention / Treatment
-----------------
* Drug: i.v. recombinant human C1 inhibitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Main inclusion Criteria: Clinical and laboratory diagnosis of HAE Plasma level of functional C1INH of less than 50% of normal Severe attack of abdominal, facial-oro-pharyngeal, genito-urinary and/or peripheral HAE. Main exclusion Criteria: Acquired angioedema Pregnancy or breastfeeding Participation in another clinical study within prior 3 months

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>Open-label i.v. administration of 100 U/kg rhC1INH | Drug: i.v. recombinant human C1 inhibitor<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary outcomes: Relief of angioedema symptoms |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary outcomes: Safety and tolerability; pharmacokinetics/pharmacodynamics |  |  |
A Pharmacogenomics Study of Simvastatin-Induced Adverse Drug Reaction

Study Overview
=================
Brief Summary
-----------------
Adverse reactions of simvastatin are mostly slight and transient, however, the incidence of simvastatin-induced hepatic impairment and myopathy are obviously higher in Chinese population than other racial groups. There is still lack of research data in Chinese. In this study, we will investigate whether there are specific genotypes which may predict the incidence of simvastatin-induced hepatic impairment and myopathy in Chinese so as to provide a basis for developing guidelines on precise medication in simvastatin therapy apply to Chinese population.

Official Title
-----------------
A Pharmacogenomics Study of Simvastatin-Induced Adverse Drug Reaction

Conditions
-----------------
Simvastatin Adverse Reaction, Pharmacogenomics, Accurate Medication

Intervention / Treatment
-----------------
* Genetic: detection of genotype


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients taking simvastatin therapy Signed informed consent. Exclusion Criteria: Patients not taking simvastatin therapy Intolerance or unwillingness to blood sample collection.

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 |
| --- | --- |
| wild genotype<br>Through next generation sequencing, distinguish wild genotype of simvastatin | Genetic: detection of genotype<br>* detection of genotype by next generation sequencing<br>|
| mutant genotype<br>Through next generation sequencing, distinguish mutant genotype of simvastatin | Genetic: detection of genotype<br>* detection of genotype by next generation sequencing<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of hepatic impairment |  | At 2 years | 
| Incidence of myopathy |  | At 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Genotype detected by next generation sequencing | Collect blood specimen before simvastatin administration, then detect genotype of simvastatin by next generation sequencing. | pre-dose of simvastatin(Baseline) |
An STD Prevention Intervention for Men Newly Released From Jail

Study Overview
=================
Brief Summary
-----------------
Study participants who are exposed to the intervention will: 1)report more condom use during sexual episodes; 2) have fewer new and repeat STD infections 3)demonstrate greater risk reduction, communication, and anger management skills; 4) report fewer substance use behaviors, and 5)report more health care seeking activities, than the participants in the control group

Detailed Description
-----------------
The MISTERS study is a randomized control trial of a cognitive-behavioral skill building multi-session intervention that targets men who are newly released from jail and have a history of drug use. Men 45 days or less post release with self reported HIV negative and substance use histories were randomized into either a 5-session intervention or control group. Study participation included four time-sensitive interviews and STD testing at three time periods. The interview questions included demographics, STD history and knowledge, sexual risk behaviors, as well as an assessment of anger management, communication, and condom use skills.

Official Title
-----------------
The MISTERS Project: An STD Prevention Intervention for Men Newly Released From Jail

Conditions
-----------------
Sexually Transmitted Diseases, Risk Behavior

Intervention / Treatment
-----------------
* Behavioral: The MISTERS Intervention for Post Jail Release Men


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ages 18 to 60, English speaking, not in jail for sexual offenses (rape or child molestation), reported risk behavior in two months prior to incarceration, weekday and evening availability, viable contact information, self-reported HIV negative status, released from jail no more than 45 days prior, and not visibly under the influence of drugs or alcohol at the time of eligibility determination Exclusion Criteria: Opposite of the above

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

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: The MISTERS Intervention for Post Jail Release Men|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in risk behaviors |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reported STDs |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sexually transmitted diseases, Risk Behavior
Optic Nerve Sheath Diameter in Craniosynostosis

Study Overview
=================
Brief Summary
-----------------
Changes of optic nerve sheath diameter after position changes

Detailed Description
-----------------
Changes of optic nerve sheath diameter after position changes from supine to prone position in children for craniosynostosis

Official Title
-----------------
Changes of Optic Nerve Sheath Diameter in Modified Prone Position in Craniosynostosis Children

Conditions
-----------------
Optic Nerve Sheath Diameter

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: craniosynostosis Exclusion Criteria: infection on eye area

Ages Eligible for Study
-----------------
Maximum Age: 12 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 |
| --- | --- | --- |
| optic nerve sheath diameter | optic nerve sheath diameter measure with ultrasound | 10 minutes after prone position |
Neural Changes in the Aging Auditory System

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to determine the effects of hormone replacement therapy (HRT) on hearing in post-menopausal women.

Detailed Description
-----------------
Background: Female hormone influences on the development and aging of the auditory system are not completely understood. The present study retrospectively analyzed and compared hearing abilities among post-menopausal women taking hormone replacement therapy (HRT), treated with estrogen and progesterone (E+P); estrogen alone (E), and a third (control - NHRT) group, matched for age, who did not receive any HRT. Methods: 126 subjects, (60-86 yr), N=32, E+P; N=31, E; N= 63, NHRT; matched for age and health status participated. All had relatively healthy medical histories, absence of significant noise exposure, middle ear problems, major surgeries or current/heavy smoking. Hearing tests included pure tone audiometry (PTA), tympanometry, distortion-product otoacoustic emissions (DPOAEs), transient otoacoustic emissions (TEOAEs) and hearing-in-noise-test (HINT). The latter is a test for speech perception in background noise: the major complaint of hearing-impaired persons. .

Official Title
-----------------
Age-Related Hearing Loss: Presbycusis & Its Neural Bases

Conditions
-----------------
Progesterone, Estrogens, Hearing, Psychoacoustics, Auditory Perceptual Disorders

Intervention / Treatment
-----------------
* Drug: Hormone Replacement Therapy - HRT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy middle ears Exclusion Criteria: ototoxic medications serious medical health problems neurological conditions Meniere's disease or labyrinthitis those who failed cognitive screening tests (Mini-Mental Test) current/heavy smokers conductive hearing loss history of noise damage and/or audiograms signifying noise damage poor speech discrimination scores (80% or less)

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 86 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Hormone Replacement Therapy - HRT|nan|

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
-----------------
Hearing Loss, Central, Presbycusis, Hearing Loss, Sensorineural, Hearing Loss, Cochlear, Hearing Loss, Bilateral, Sex Steroid Hormones, Estradiol
Megavec 400 mg (Imatinib Mesylate) in Healthy Adult Male Volunteers

Study Overview
=================
Brief Summary
-----------------
The purpose of this Study is to Assess Safety and Pharmacokinetics of megavec 400 mg (Imatinib mesylate) under Fasted Conditions in Healthy Male Subjects.

Official Title
-----------------
A Randomized, Open-label, Single Dose, 2-Treatment, 2-Period, 2-Way Crossover Study to Assess Safety and Pharmacokinetics of Megavec 400 mg (Imatinib Mesylate) Under Fasted Conditions in Healthy Male Subjects

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

Intervention / Treatment
-----------------
* Drug: Megavec
* Drug: Glivec


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy and male subjects aged 20 to 55 years The subject has a Body weight ≥55 kg and ideal body weight (IBW) within ±20% A Subject who was judged to be healthy by the investigator to participate in this study based on screening results (according to standard reference index updated recently) A subject who provided written informed consent to participate in this study and cooperative with regard to compliance with study related constraints. Exclusion Criteria: A subject with sign or symptoms or previously diagnosed disease of respiratory, cardiovascular, endocrinology, liver, kidney, hematology, neurology and psychology function or other significant diseases and history Known allergy or hypersensitivity to the study medication AST or ALT greater than 1.25 times the upper limit of reference range or Total bilirubin greater than 1.25 times the upper limit of reference range base on screening results A subject judged ineligible by the investigator to participate in this study for other reason containing clinical laboratory tests

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Megavec<br> | Drug: Megavec<br> <br> Drug: Glivec<br> <br> |
| Active Comparator: Glivec<br> | Drug: Megavec<br> <br> Drug: Glivec<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | Adverse events, Physical exam, Vital sign, Laboratory, 12-lead-ECG |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics | AUC and Cmax in plasma |  |