louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02569502: A Study of Enfuvirtide (Fuzeon) in Patients With Advanced Human Immunodeficiency Virus-1 (HIV-1) Infection
Official title: Open Label, Nonrandomized Clinical Trial of Safety and Tolerability of Enfuviritide (Fuzeon®, HIV Fusion Inhibitor) in Patients With Advanced HIV1 Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: HIV Infections
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-10-06
Enrollment: 6
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety and tolerability of subcutaneous Fuzeon in patients with advanced HIV-1 infection unable to construct an appropriate treatment regimen from currently available antiretroviral agents. The anticipated time on study treatment is 3-12 months, and the target sample size is 9 individuals.


Eligibility criteria: Inclusion Criteria:

* Adult or adolescent patients greater than (\>)16 years of age
* HIV-1 infection
* CD4 count less than (\<)350/cubic millimeters (mm\^3)
* HIV RNA viral load \>10,000 copies per milliliter (copies/mL) while on highly active antiretroviral therapy (HAART)
* Documented resistance, treatment-limiting toxicity, and/or \>=6 months' prior experience with each of 3 currently available classes of antiretroviral drugs.

Exclusion Criteria:

* Women who are pregnant or breastfeeding;
* Patients unable to self-inject;
* Active, untreated opportunistic infection.

Primary outcomes:
measure: Percentage of participants who discontinue enfuvirtide due to adverse events\n
timeFrame: Up to 102 weeks
measure: Percentage ofparticipants who discontinue from tratment since they no longer wish to continue with the injections
timeFrame: Up to 102 weeks
measure: Percentage of participants with Serious Adverse Events (SAEs) and Serious AIDS-Defining events
timeFrame: Up to 102 weeks
Secondary outcomes:
measure: Percentage os participants reporting serious adverse events on the first day of study dosing and up to 28 days after discontinuiation of the study drug
timeFrame: Up to 28 days after discontinuation of enfuvirtide
measure: Percentage of participants with Injection Site Reactions (ISR) and who discontinued enfuvirtide due to ISR
timeFrame: Up to 102 weeks
Other outcomes:
Locations:
city: Sofia
country: Bulgaria
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_CHAIR
References:
Clinical trial NCT00000302: Study Comparing Liquid and Tablet Buprenorphine Formulations - 5
Official title: Expanded Steady-State Pharmacokinetic Study, Comparing Liquid and Tablet Buprenorphine Formulations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Heroin Dependence
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 1999-09-21
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare liquid and tablet buprenorphine formulations.

Detailed description: Participants were inducted on either liquid or tablet buprenorphine, in a double-blind, double-dummy manner. They each reached a steady state by the second week, and were scheduled to have blood draws in weeks 3, 4, 7, 8, 11, 12, 15, and 16.

Eligibility criteria: Inclusion Criteria:

M/F ages 21-50. Opiate dependence according to DSM-IV criteria. Currently enrolled in the outpatient protocol comparing liquid and tablet formulations of Buprenorphine. Agreeable to conditions of study and signed informed consent.

Exclusion Criteria:

Psychiatric disorder that requires medication therapy. History of seizures. Pregnant and/or nursing women. Dependence on ETOH or benzodiazepines or other sedative-hypnotics. Acute hepatitis. Other medical conditions that deem participation to be unsafe.

Primary outcomes:
measure: Drug use
measure: Retention
measure: Drug craving
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Friends Research Institute
state: California
Study officials:
affiliation: Friends Research Institute, Inc.
name: Walter Ling, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03925402: Ertapenem for Initial Empirical Treatment of Third Generation Cephalosporin Resistant Enterobacteriaceae Bacteremia
Official title: Ertapenem for Initial Empirical Treatment of Third Generation Cephalosporin Resistant Enterobacteriaceae Bacteremia: a Propensity Score Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bacteremia
Infection, Bacterial
Lead sponsor: Phramongkutklao College of Medicine and Hospital
Sponsor class: OTHER
First posted: 2019-04-24
Enrollment: 427
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients 18 years of age and older admitted to Phramongkutklao Hospital, and Ananda Mahidol Hospital with 3GCRE monomicrobial bacteremia will be prospectively identified. In given a patient, only the initial episode of 3GCRE monomicrobial bacteremia during the study period will be included.

Brief summary: This study aims to assess whether ertapenem as an empiric treatment of third-generation-cephalosporin resistant Enterobacteriaceae (3GCRE) bacteremia is non-inferior to other carbapenems in term of 30-day mortality.

Detailed description: There are limited data of the efficacy of ertapenem as the empiric treatment of serious invasive infections, such as bloodstream infections (BSIs), that are due to ESBL-producing Enterobacteriaceae. Previous studies of ertapenem were done in small group of patients, in less invasive infection, as a definite 'step-down' therapy, or as compared to other non-carbapenem antibiotics.

Eligibility criteria: Inclusion Criteria:

* Adults, either sex, ages 18 years or above
* Patients with 3GCRE bacteremia
* Patients admitted to any of the study sites

Exclusion Criteria:

* Discontinuation of antibiotic due to transition to hospice care
* Polymicrobial bacteremia
* Empirical antibiotic after 24 hours of first evidence of bacteremia

Primary outcomes:
measure: 30-day mortality
timeFrame: 30 days
Secondary outcomes:
measure: In-hospital mortality
timeFrame: 90 days
measure: 14-day mortality
timeFrame: 14 days
measure: 90-day mortality
timeFrame: 90 days
measure: • Length of stay
timeFrame: 90 days
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Phramongkutklao Hospital
Study officials:
References:
Clinical trial NCT01161602: A Study to Evaluate the Safety, Tolerability and Pharmacodynamics of Pumosetrag in Patients With Gastroesophageal Reflux Disease (GERD)
Official title: A Phase IIa, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Pharmacodynamics of Multiple Dose Levels of Pumosetrag in Patients With Symptoms Associated With Gastroesophageal Reflux Disease (GERD) Receiving a Standard Refluxogenic Meal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastroesophageal Reflux Disease
Keywords: Symptoms of Gastroesophageal Reflux Disease (GERD)
Lead sponsor: Edusa Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2010-07-13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: The purpose of this study is to determine if pumosetrag is effective in treating Gastroesophageal Reflux Disease (GERD) symptoms in patients who have a history of GERD symptoms and are currently taking an acid suppression therapy, such as a Proton Pump Inhibitor (PPI).


Eligibility criteria: Inclusion Criteria:

* Patients with history of Gastroesophageal Reflux Disease (GERD) symptoms (heartburn, regurgitation, acid taste in mouth).
* Between ages of 18 - 70 inclusive.
* Develop GERD symptoms following ingestion of a refluxogenic meal.
* Able to take a stable Proton Pump Inhibitor (PPI) regimen for duration of study.
* Understand and sign the informed consent form.

Exclusion Criteria:

* Pregnant or lactating women.
* Allergic to pumosetrag or formulation excipients.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic Scottsdale
state: Arizona
city: Anaheim
country: United States
facility: Advanced Clinical Research Institute
state: California
city: Jacksonville
country: United States
facility: Mayo Clinic Jacksonville
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
Study officials:
References:
Clinical trial NCT02145702: Impact of Exercise on Cognitive Impairment in End-Stage Renal Disease
Official title: Impact of Exercise on Cognitive Impairment in End-Stage Renal Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cognitive Impairment
End-Stage Renal Disease
Keywords: ESRD
Kidney Failure
Exercise
Cognitive impairment
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2014-05-23
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the impact of 12 weeks of exercise on cognition in patients with end stage renal disease.

Detailed description: Patients with end stage renal disease have higher cognitive impairment than general population. They also have decreased physical and functional capacity. Exercise has shown to improve cognition in general population. This study will evaluate if exercise improves cognition in dialysis patients. It will also evaluate whether exercise affects performance in daily activities, mood or depression and inflammatory markers in the blood.

Eligibility criteria: Inclusion Criteria:

* Patients with ESRD on dialysis
* Age greater than 20 years
* Have means of transportation to and from the exercise session
* Speak English (as the neuropsychological tests will be performed in English)

Exclusion Criteria:

* Recent myocardial infarction (within 6 weeks), unstable angina, uncontrolled arrhythmias, congestive heart failure (\> NYHA grade II)
* History of stroke in the last 2 months
* Active respiratory disease
* Uncontrolled hypertension
* Severe uncontrolled diabetes
* Persistent predialysis hyperkalemia
* Active decompensated liver disease
* Symptomatic peripheral vascular disease
* Musculoskeletal abnormalities that will be prohibit their participation in the exercise program
* Health conditions needing frequent hospitalizations
* Other health conditions causing inability to follow exercise program correctly
* Unwillingness to participate in structured exercise program
* Current use of antipsychotics or anti-epileptics
* Inability to hear, read or write which will limit their ability to perform the cognitive tests

Primary outcomes:
measure: Feasibility
timeFrame: Up to 26 Weeks
Secondary outcomes:
measure: Cognitive function
timeFrame: Baseline, within1 week before and within 1 week after exercise intervention
measure: Markers of inflammation
timeFrame: Baseline, within 1 week before and within 1 week after exercise intervention
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Aditi Gupta, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01472302: Closed Loop Ventilation Strategy in Intensive Care Unit (ICU) Patients
Official title: Effect of a Closed Loop Ventilation Strategy on Reducing the Total Duration of Mechanical Ventilation of Intubated Intensive Care Unit Patients: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Respiratory Failure
All Intubated Patients
Lead sponsor: Izmir Dr Suat Seren Chest Diseases and Surgery Education and Research Hospital
Sponsor class: OTHER
First posted: 2011-11-16
Enrollment: 229
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Adaptive support ventilation (ASV) is a closed loop ventilation mode that can act both like PCV and PSV automatically. Some studies suggest that ASV can reduce the weaning time in ICU patients. The investigators hypothesized that using ASV from the beginning of intubation can reduce the total duration of MV and LOS in the ICU when compared to conventional modes such as PCV+PSV


Eligibility criteria: Inclusion Criteria:

* Intubated and mechanically ventilated ICU patients for more than 24 hours

Exclusion Criteria:

* Patient with a tracheostomy
* Patients under home mechanical ventilation

Primary outcomes:
measure: Duration of mechanical ventilation
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Izmir Chest Diseases and Surgery Education and Research Hospital, Intensive Care Unit
state: Yenisehir
Study officials:
affiliation: Izmir Dr. Suat Seren Chest Diseases and Surgery Training Hospital
name: Cenk Kirakli, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kirakli C, Naz I, Ediboglu O, Tatar D, Budak A, Tellioglu E. A randomized controlled trial comparing the ventilation duration between adaptive support ventilation and pressure assist/control ventilation in medical patients in the ICU. Chest. 2015 Jun;147(6):1503-1509. doi: 10.1378/chest.14-2599.
Clinical trial NCT03271502: Effect of Anesthesia on Optic Nerve Sheath Diameter in Patients Undergoing Robot-assisted Laparoscopic Prostatectomy
Official title: Effect of Inhalation Anesthesia With Sevoflurane and Total Intravenous Anesthesia With Propofol on Optic Nerve Sheath Diameter in Patients Undergoing Robot-assisted Laparoscopic Prostatectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2017-09-05
Enrollment: 36
Sex: MALE
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study was to evaluate the difference between the optic nerve sheath diameter measured during total intravenous anesthesia and the optic nerve sheath diameter measured during inhalation anesthesia in patients undergoing robot-assisted laparoscopic prostatectomy.

Detailed description: The purpose of this study was to evaluate the difference between the optic nerve sheath diameter measured during total intravenous anesthesia with propofol and remifentanil and the optic nerve sheath diameter measured during inhalation anesthesia with sevoflurane and remifentanil in patients undergoing robot-assisted laparoscopic prostatectomy.

Eligibility criteria: Inclusion Criteria:

Patients who have undergone a robot-assisted laparoscopic prostatectomy with a prostate cancer and who are 20 years of age or older and under 80 years of age and who agree to participate in this study.

Exclusion Criteria:

Patients with a history of cerebral hemorrhage or cerebral infarction, Patients \< 20 years of age, Patients ≥ 80 years of age, Patients with unexpected hemodynamic instability during surgery, Failure to measure optic nerve sheath diameter.

Primary outcomes:
measure: Difference in optic nerve sheath diameter
timeFrame: 60 minutes after pneumoperitoneum and steep Trendelenburg position
Secondary outcomes:
measure: Difference in optic nerve sheath diameter
timeFrame: 30 minutes after pneumoperitoneum and steep Trendelenburg position
measure: Difference in optic nerve sheath diameter
timeFrame: 5 minutes after pneumoperitoneum and steep Trendelenburg position
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Young-Kug Kim, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yu J, Hong JH, Park JY, Hwang JH, Cho SS, Kim YK. Propofol attenuates the increase of sonographic optic nerve sheath diameter during robot-assisted laparoscopic prostatectomy: a randomized clinical trial. BMC Anesthesiol. 2018 Jun 20;18(1):72. doi: 10.1186/s12871-018-0523-7.
Clinical trial NCT01983202: Obstetric Outcomes in Women With PCOS
Official title: Size at Birth in Newborn Children and Obstetric Outcomes in Women With PCOS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Polycystic Ovary Syndrome, PCOS
Keywords: PCOS
Pregnancy
Obstetric
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2013-11-13
Enrollment: 1248
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 208 women diagnosed with PCOS at Department of Endocrinology and Metabolism and giving birth at Odense University Hospital during 2003-2011. Women with PCOS are matched 1:5 to a date-of-childbirth matched control group of 1040 pregnant women giving birth at Odense UNivesity Hospital.

Brief summary: The aim of the study is to investigate body composition in newborn children of women with PCOS and controls and to investigate adverse obstetric outcomes in pregnant women with PCOS.

Detailed description: A prospective cohort study investigating 208 women with PCOS giving birth after singleton pregnancies at Odense Univesity Hospital during 2003-2011 and a date-of-childbirth matched control group of 1040 women. Anthropometric data from children is recorded as well as data on maternal parity, age, pre-gestational BMI, and adverse obstetric outcomes.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with PCOS and giving birth during 2003-2011

Exclusion Criteria:

* Multiple pregnancy

Primary outcomes:
measure: Anthropometric measures
timeFrame: Date of birth (1 day)
Secondary outcomes:
measure: Adverse obstetric outcomes
timeFrame: From beginning of pregnancy until the date of delivery (approximately 9 months)
Other outcomes:
measure: Neonatal complications
timeFrame: Date of birth (1 day)
Locations:
city: Odense
country: Denmark
facility: Department of Endocrinology, Odense University Hospital
Study officials:
affiliation: Odense University Hospital
name: Marianne Andersen, DMSci
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01989702: Effect of a Probiotic-based Product on Blood Pressure
Official title: The Effect of a Probiotic-based Product on Blood Pressure and Other Known Risk Factors Linked to Cardiovascular Diseases.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Pressure
Lead sponsor: Probi AB
Sponsor class: INDUSTRY
First posted: 2013-11-21
Enrollment: 142
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the present study was to examine the efficacy of a probiotic-based product on either reducing hypertension or preventing a high normal blood pressure from reaching hypertensive levels.


Eligibility criteria: Inclusion Criteria:

* Healthy individuals at the age of 40-75 years.
* Blood-pressure \>140/90 mmHg that has been confirmed at 2-3 separate occasions or represents the mean value of a 24-hour measurement.
* Triglycerides \>1,7 mmol/L and/or HDL \<1 mmol/L (men)/1,29 mmol/L (women).
* Fasting plasma glucose levels \>5,6 mmol/L and/or waist circumference \>102 cm (men)/88 cm (women).
* BMI \<40.

Exclusion Criteria:

* Medically treated allergy or allergy to any of the ingredients of the study product.
* Medication for high levels of blood lipids.
* Metabolic disease, such as type one diabetes.
* Confirmed diseases of the heart, liver of kidneys.
* Chronic inflammatory disease requiring medication.
* Pregnant or nursing.
* Regular intake of other probiotic products (5-7 days per week during the last three months before inclusion into the study).

Primary outcomes:
measure: Changes from baseline in systolic and diastolic blood pressure after 3 months of probiotic intervention
timeFrame: Baseline, 3 months
Secondary outcomes:
measure: Changes from baseline of blood parameters, such as inflammatory markers and blood lipids, linked to increased risk for cardiovascular diseases
timeFrame: Baseline, 3 months
Other outcomes:
measure: Effect of study product on intestinal microbiota as analysed in fecal samples
timeFrame: Baseline, 3 months
Locations:
city: Malmö
country: Sweden
Study officials:
References:
Clinical trial NCT00688402: Study to Compare Different Formulations of AZD3355
Official title: A Double-blind, Randomized, Cross-over Design, Phase 1 Pharmacodynamic Study to Investigate the Effect of Different Formulations of AZD3355 for the Development of Paresthesiae After Dosing in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Gastroesophageal Reflux Disease
Keywords: Reflux Inhibitor
GERD
formulations
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-06-03
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the study is to compare different formulations of AZD3355 in regard to possible adverse events such as sensations of numbness, tinglings and heat in the skin.


Eligibility criteria: Inclusion Criteria:

* Provision of written informed consent
* Female subjects with no childbearing potentials or using highly efficient contraceptive methods
* Clinically normal physical findings

Exclusion Criteria:

* Clinically significant illness within 2 weeks prior to the first dose of investigational product
* History of clinically significant disease
* Use of prescribed medication during the 2 weeks before administration of the first dose of investigational product

Primary outcomes:
measure: Specific AE questions
timeFrame: During 0-4 hours post dose
Secondary outcomes:
measure: PK variables
timeFrame: Frequent sampling up to 36 hours post dose
measure: Safety variables (other adverse events, blood pressure, pulse, safety lab)
timeFrame: During the whole treatment period
Other outcomes:
Locations:
city: Varvsgatan
country: Sweden
facility: Research Site
state: Lulea
Study officials:
affiliation: AstraZeneca R&D, Mölndal, Sweden
name: Eva Ersdal, PhD
role: STUDY_DIRECTOR
affiliation: Quintiles Hermelinen, Varvsgatan 53, SE-972 33 Luleå, Sweden
name: Aslak Rautio, MD
role: PRINCIPAL_INVESTIGATOR
References: