louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03905954: The Impact of a Diagnosis of Parkinson's on Work
Official title: The Impact of a Diagnosis of Parkinson's on Work
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Keywords: employment
work
diagnosis
early support
Lead sponsor: Oxford Brookes University
Sponsor class: OTHER
Collaborators: name: European Parkinson's Therapy Centre
First posted: 2019-04-08
Enrollment: 696
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A (European) community based convenience sample. The survey will be available to the European Parkinson's Disease Association (EPDA) network using the Members' forum and website and will be sign posted through ongoing Member Outreach communication channels.

Brief summary: Parkinson's disease leads to loss of employment on average within less than 10 years of disease onset and has been found to be associated with an increased absence from work. This combined with hospitalisation; use of secondary health services; drug usage; and caregivers needing to give up work contributed to the costs associated with the conditions. It has been estimated that early support for working age newly diagnosed would cost the government about 1.5 million Euro in the UK but might lead to a potential cost saving of over half a billion over 5 years.

The study will explore the impact of a Parkinson diagnosis on employment. The study will be survey based and will include demographic questions: age, age at diagnosis of PD, educational level, and Nationality; questions pertaining to employment type, history, and reasons for leaving if this happened; and also general health.


Eligibility criteria: Inclusion Criteria:

Diagnosis of Parkinson

Exclusion Criteria:

None

Primary outcomes:
measure: Main occupation in the last 7 days
timeFrame: baseline only (cross sectional)
Secondary outcomes:
measure: Type of Work
timeFrame: baseline only (cross sectional)
measure: Symptom Severity-Distress
timeFrame: baseline only (cross sectional)
measure: Symptom Severity-Pain
timeFrame: baseline only (cross sectional)
measure: Symptom Severity-Fatigue
timeFrame: baseline only (cross sectional)
measure: Symptom Severity-Depression
timeFrame: baseline only (cross sectional)
measure: Symptom Severity-Anxiety
timeFrame: baseline only (cross sectional)
measure: Symptom Severity - Sleep
timeFrame: baseline only (cross sectional)
measure: Single Item Physical activity
timeFrame: baseline only (cross sectional)
measure: Single Item Diet
timeFrame: baseline only (cross sectional)
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: Oxford Brookes University
state: Oxfordshire
Study officials:
References:
Clinical trial NCT00715754: Antecedents of Obesity: Fetal Measures of Adiposity
Official title: Antecedents of Obesity: Fetal Measures of Adiposity, "A Plan for Obesity Disaster Management"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2008-07-15
Enrollment: 47
Sex: ALL
Minimum age (years): 24
Maximum age (years): 72
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children born at the University of Utah Hospital, whose mothers received prenatal care also at the University of Utah Hospital.

Brief summary: The purpose of this research is to study whether fetal biometrics obtained by 2-D ultrasound can predict infant adiposity by air displacement plethysmography at birth.


Eligibility criteria: Inclusion Criteria:

* Infants of mothers between the ages of 18 and 45, planning child birth at the University of Utah Hospital, and willing to provide parental permission for the child to participate in the study.

Exclusion Criteria:

* Infants of mothers under the age of 18, over the age of 45, planning child birth at another facility other than the University of Utah Hospital, or who are not willing to provide permission for the child to participate in the study.

Primary outcomes:
measure: Infant Adiposity at 24-72 Hours Following Birth
timeFrame: 24-72 hours following birth
measure: Fetal Abdominal Circumference
timeFrame: 35 weeks gestation
measure: Estimated Fetal Weight Percentile
timeFrame: 35 weeks gestation
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Utah
name: Laurie Moyer-Mileur, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00230854: Study in Non-responder Hepatitis C Genotype 1 Patients With EMZ702, Pegylated Interferon and Ribavirin
Official title: An Open Label, Dose Escalation Study of EMZ702 in Combination With Pegylated Interferon and Ribavirin in Patients With Chronic Hepatitis C Genotype 1 Non-responsive to Prior Therapy With Pegylated Interferon and Ribavirin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Chronic Hepatitis C
Hepatitis, Viral, Human
Keywords: hepatitis C
genotype 1
non-responders
viral hepatitis
Lead sponsor: OPKO Health, Inc.
Sponsor class: INDUSTRY
First posted: 2005-10-03
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety and efficacy of repeated intravenous infusions of EMZ702 in combination with pegylated interferon and ribavirin in patients with chronic hepatitis C genotype 1.

Detailed description: In this study, 28 patients with chronic hepatitis C genotype 1 who have failed previous treatment with pegylated interferon plus ribavirin will be treated. The study treatment will consist of the same type and doses of pegylated interferon and ribavirin to which the patient failed to respond plus EMZ702. EMZ702 will be administered intravenously twice a week during the first 12 weeks of treatment. Thereafter and according to viral response, patients will continue to receive pegylated interferon and ribavirin only for up to 36 weeks.

Eligibility criteria: Inclusion Criteria:

* Hepatitis C virus (HCV) genotype 1
* Previous therapy with pegylated interferon and ribavirin
* Documented previous treatment failure

Exclusion Criteria:

* Hepatic dysfunction
* Coinfection with hepatitis B or HIV
* Other unrelated liver diseases
* Liver cancer

Primary outcomes:
measure: To evaluate the safety and tolerability of repeated intravenous infusions of EMZ702 in combination with pegylated interferon and ribavirin in patients with chronic hepatitis C genotype 1
Secondary outcomes:
measure: To evaluate the viral response and pharmacokinetic profile of repeated intravenous infusions of EMZ702 in combination with pegylated interferon and ribavirin in patients with chronic hepatitis C genotype 1
Other outcomes:
Locations:
city: London
country: Canada
facility: L.H.S.C. University Campus
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Hospital
state: Ontario
Study officials:
affiliation: OPKO Health, Inc.
name: Aleksandra Pastrak, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00579254: Real Life Experience With Caduet In Patients With Cardiovascular Risk Factors
Official title: Real Life Experience With Caduet Evaluating Effectiveness, Safety and Tolerability in the Management of Cardiovascular Risk Factors (EXCEL Study)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hypertension and Cardiovascular Risk Factors
Keywords: Efficacy,safety & tolerability of Caduet In Patients With Cardiovascular Risk Factors
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-12-24
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be treated in this study according to prevailing local clinical practice following the locally approved product labeled recommendations

Brief summary: To assess the effect of single pill therapy on the management of hypertension and other cardiovascular risk factors (e.g., dyslipidemia) in Indian patients in whom the treating doctor has already considered that the administration of the amlodipine/atorvastatin single pill to be appropriate

Detailed description: Patients who have been prescribed single pill Caduet are eligible to participate in this study. The treating physician will obtain written informed consent from each subject or the subject's legally acceptable representative before any study-specific activity is performed.

The study terminated on May 5, 2008. The decision to terminate was due to inability to achieve study timelines and undue delay in obtaining IEC/IRB permission at some sites. No safety or efficacy issues caused the decision to terminate.

Eligibility criteria: Inclusion Criteria:

Patients who have been prescribed single pill Caduet are eligible to participate in this study. Patients will be treated in this study according to prevailing local clinical practice following the locally approved product labeled recommendations.

Exclusion Criteria:

* Known hypersensitivity to dihydropyridines, amlodipine, atorvastatin, or any component of this medication,
* Active liver disease or unexplained persistent elevations of serum transaminases exceeding three times the upper limit of normal,
* Or who are pregnant, breast-feeding, or of childbearing potential who are not using adequate contraceptive measures. Amlodipine/atorvastatin should be administered to women of childbearing age only when such patients are highly unlikely to conceive and have been informed of the potential hazards to the fetus.

Primary outcomes:
measure: Change in Systolic and Diastolic Blood Pressure
timeFrame: Baseline, 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT00701454: Survey of Thai-Muslim Health Status
Official title: Survey of Thai-Muslim Health Status
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Hypertension
Hyperlipidemia
Keywords: Thai-muslim
Thai-HALAL
Diabetes
Hypertension
Hyperlipidemia
Metabolic syndrome
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2008-06-19
Enrollment: 1488
Sex: ALL
Minimum age (years): 35
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Thai muslim residents in 4 muslim communities in and around Bangkok.

Brief summary: The purpose of this study was to determine the prevalence and risk factors of diabetes, hypertension, hyperlipidemia among Thai muslim population aged 35-75 years.

Detailed description: This was a cross-sectional study conducted in Bangkok and surrounding provinces. Approximately 1500 participants were enrolled. Study staff interviewed participants on basic demographic data, health status, physical activities, food frequency and 24-hour recall. Anthropometry (body weight, height, hip and waist circumference) and physical assessment (blood pressure)were measured. Ten milliliters of venous blood was drawn by venipuncture after a 12 h overnight fast for determination of fasting plasma glucose (FPG) and blood lipid concentrations (total cholesterol, triglyceride, and HDL-cholesterol). FPG was measured by the enzymatic colorimetric method with glucose oxidase.21 Total cholesterol was determined by the cholesterol oxidase method and serum triglycerides concentration was determined by standardized enzymatic procedures using glycerol phosphate oxidase assay.22, 23 HDL- cholesterol was measured by enzymatic assays.24 LDL cholesterol was calculated according to the method of Friedwald et al.25 All samples were analyzed when internal quality control met the acceptable criteria. Intra-and inter-assay CVs were 2.01% and 3.01% for FPG, 1.87% and 4.24% for total cholesterol, 0.93% and 11.6% for triacylglycerols, and 0.99% and 1.49% for HDL cholesterol, respectively.

Eligibility criteria: Inclusion Criteria:

* 35 y and older muslim
* free from severe communicable diseases and mental disorders

Exclusion Criteria:

* not able to complete the interviews or obtain blood samples for analysis

Primary outcomes:
measure: prevalence of diabetes, hypertension and hyperlipidemia
timeFrame: after a 12 h overnight fast
Secondary outcomes:
Other outcomes:
Locations:
city: Phuttamonthon
country: Thailand
facility: Institute of Nutrition, Mahidol University
state: Nakhon Pathom
Study officials:
affiliation: Mahidol University
name: Emorn Wasantwisut, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00519454: Estrogen and Gender Biased Autoimmunity
Official title: Estrogen and Gender Biased Autoimmunity in Systemic Lupus Erythematosus
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Systemic Lupus Erythematosus
Keywords: Systemic Lupus Erythematosus
Estrogen receptors
T cells
Hormones
Female adult SLE
Lead sponsor: The Center for Rheumatic Disease, Allergy, & Immunology
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2007-08-22
Enrollment: 75
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female subjects with SLE and still cycling, not on hormones, compared to normal controls, female subjects still cycling, also not on hormones and not diagnosed with SLE.

Brief summary: This study involves research to investigate how estrogen affects women of childbearing age and its correlation to Systemic Lupus Erythematosus. The findings from this study might help determine how body cells, called T Cells, react to estrogen. The study will seek to determine if cells from women with Lupus, react differently from cells in persons without Lupus. We will attempt to identify genetic factors that determine the effects of estrogen on Lupus cells.

Detailed description: This is a 3-year study. The total number of subjects enrolled will depend on the results obtained. The subjects will be at least 18 years of age and pre-menopausal. Exclusion to include pregnant women, and all subjects are told not to get pregnant while on study. Also, they cannot take hormones by mouth or patch while on study. The study can include healthy subjects as well. Blood will be drawn (120 ml) four times a year, randomly.

Eligibility criteria: Inclusion Criteria:

* female subjects with Lupus, and female subjects without Lupus. age at least 18, not pregnant and not planning to get pregnant.

Exclusion Criteria:

* Pregnant or planning to get pregnant. On hormone replacement, or birth control of any kind.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: The Center for Rheumatic Disease, Allergy and Immunology
state: Missouri
Study officials:
affiliation: The Center for Rheumatic Disease, Allergy and Immunology
name: Nabih I Abdou, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01161654: Bioequivalency Study of Naratriptan Hydrochloride 2.5 mg Under Fed Conditions
Official title: A Single Dose, Two-Period, Two-Treatment, Two-Way Crossover Bioequivalence Study of Naratriptan Hydrochloride 2.5 mg Tablets Under Fed Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Migraine
Lead sponsor: West-Ward Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2010-07-13
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study was to prove the bioequivalence of Naratriptan Hydrochloride Tablet under fed conditions.


Eligibility criteria: Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to naratriptan hydrochloride or any comparable or similar product.

Primary outcomes:
measure: bioequivalence determined by statistical comparison Cmax
timeFrame: 9 days
Secondary outcomes:
Other outcomes:
Locations:
city: Tacoma
country: United States
facility: Charles River Northwest Kinetics
state: Washington
Study officials:
affiliation: Charles River Northwestern Kinetics
name: Linda Bavisotto, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04646954: DNA Methylation Testing for the Screening of Uterine Cervical Lesion
Official title: DNA Methylation Testing for the Screening of Uterine Cervical Lesion: A Multicenter, Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Cervical Cancer
Cervical Intraepithelial Neoplasia
DNA Methylation
High-risk Human Papillomavirus
Cytology
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2020-11-30
Enrollment: 12000
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: All eligible participants accept DNA methylation testing, with cytology and/or hrHPV assay in a hospital-based community。
Primary purpose: DIAGNOSTIC

Brief summary: In our published work, host DNA methylation testing has been proved to be sensitive and specific to cervical intraepithelial neoplasia (CIN) 2 or more severe lesions (CIN2+). Its screening effects are independent of high-risk human papillomavirus (hrHPV) status. Based on the results of training and validation sets of our previous work, we perform this multicenter, prospective cohort study in unselected participants asking for cervical cancer screening in a hospital-based community. All eligible participants accept DNA methylation testing, with cytology and/or hrHPV assay. The primary endpoint is the diagnostic accuracy of DNA methylation compared with cytology and/or hrHPV status based on histology results. The accuracy analysis includes sensitivity, specificity, negative predictive value and positive predictive value.


Eligibility criteria: Inclusion Criteria:

* Aged 21 years or older
* Signed an approved informed consents
* Feasible to be followed up
* Available residual cytology samples for methylation analysis

Exclusion Criteria:

* Without history of cervical disease, including cervical intraepithelial neoplasia (CIN) 2 or more severe lesions (CIN2+)
* No requirement of cervical cancer screening of cytology or high-risk human papillomavirus

Primary outcomes:
measure: Diagnostic accuracy
timeFrame: Two years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Lei Li
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Lei Li, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05330754: Caffeine Intake Inrelation to Perioperative Analgesic Consumption
Official title: Effect Of Daily Caffeine Intake On Perioperative Analgesic Consumption And Recovery Time In Patients Undergoing Laparoscopic Surgeries.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Analgesia
Caffeine
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2022-04-15
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 18 - 65 years old, physical status American Society of Anesthesiology (ASA) I\&II, body weight from 70-80 kg,

Brief summary: Caffeine is the most widely consumed psychoactive drug in the world. Natural sources of caffeine include coffee, tea, and chocolate. Synthetic caffeine is also added to products to promote arousal, alertness, energy, and elevated mood.

We designed this prospective observational study to determine if caffeine consumption would influence intraoperative analgesic consumption

Detailed description: Caffeine is a well-known natural compound present in various plant products. Caffeine is an integral component of several daily drinks, including tea, coffee, soft drinks, and energy drinks \[1\]. (e consumption habits of these caffeinated drinks have facilitated the wide distribution of and dependence on caffeine. For instance, 89% of the US adult population has an average caffeine intake of 200 mg/day \[2\]. Among the multiple effects and side effects, caffeine also has an analgesic action and is used to reduce pain in several pharmaceutical forms as an adjuvant \[1\]. Several studies have reported a role for caffeine in controlling pain and suggested that caffeine may block the central processing of pain signals in the brain and enhance the body's natural pain resistance pathways \[3\]. In addition, Overstreet et al. found that habitual caffeine consumption diminishes pain sensitivity in a laboratory setting \[4\]

Eligibility criteria: Inclusion Criteria:

* Patients scheduled to undergo elective laparoscopic surgery

Exclusion Criteria:

* Patients converted to an open surgery, postoperative complications that increased postoperative pain, and those with psychological or nervous system diseases were also excluded. Liver disease

Primary outcomes:
measure: total intraoperative fentanyl consumption in microgram
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Hospitals
Study officials:
References:
Clinical trial NCT01786954: iCare vs Tonopen vs Goldmann Applanation Post-vitrectomy Surgery
Official title: A Comparative Study of Icare Rebound Tonometry With Other Tonometry Modalities in Patients Following Vitreoretinal Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intraocular Pressure
Keywords: vitreoretinal surgery
intraocular pressure
applanation
rebound
tonometry
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2013-02-08
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of the study is to compare the measurement of pressure inside the eye using three different FDA-approved devices (Icare, Tonopen, and Goldmann applanation).

Detailed description: The three above devices will be used to measure intraocular pressure in patients one day following vitreoretinal surgery. The underlying reason for surgery is not being considered in this study. The measured pressures will be compared across devices in eyes filled with fluid, gas, and silicone oil.

Eligibility criteria: Inclusion Criteria:

* Duke Eye Center patients 18 years or older
* capacity to give legally effective consent
* scheduled to undergo vitreoretinal surgery

Exclusion Criteria:

* individuals unable to give consent
* minors

Primary outcomes:
measure: Measurement of Intraocular Pressure
timeFrame: postoperative day #1
Secondary outcomes:
measure: Adverse Events
timeFrame: postoperative day #1
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Eye Center
state: North Carolina
Study officials:
affiliation: Duke University Eye Center
name: Paul Hahn, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: