louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00092885: An Approved Drug to Study a New Indication for Seasonal Allergic Rhinitis in Patients With Asthma (0476-269)
Official title: A Multicenter, Double-Blind, Randomized Study Investigating the Clinical Effect of Montelukast on Allergic Rhinitis in Patients With Seasonal Allergic Rhinitis and Chronic Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rhinitis, Allergic, Seasonal
Asthma, Bronchial
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2004-09-28
Enrollment: 831
Sex: ALL
Minimum age (years): 15
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effect of an approved medication on the symptoms of seasonal allergic rhinitis (a seasonal variety of inflammation of the mucous membrane of the nose) in patients who are experiencing symptoms of seasonal allergic rhinitis and asthma.

Detailed description: The duration of treatment is 2 weeks.

Eligibility criteria: Inclusion Criteria:

* Non-smoker
* A 2-year documented history of seasonal allergic rhinitis
* A 1-year documented history of chronic asthma
* Positive allergy testing

Exclusion Criteria:

* Medical history of a lung disorder (other than asthma) or a recent upper respiratory tract infection.

Primary outcomes:
measure: Daily Rhinitis Symptoms score; the Daytime Nasal Symptoms score and Nighttime Symptoms score
Secondary outcomes:
measure: (1) Rhinoconjunctivitis Quality-of-Life Questionnaire overall score; (2) Global Evaluation of Allergic Rhinitis by Patient; (3) Global Evaluation of Allergic Rhinitis by Physician
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Philip G, Nayak AS, Berger WE, Leynadier F, Vrijens F, Dass SB, Reiss TF. The effect of montelukast on rhinitis symptoms in patients with asthma and seasonal allergic rhinitis. Curr Med Res Opin. 2004 Oct;20(10):1549-58. doi: 10.1185/030079904x3348.
Clinical trial NCT00443885: Resistance Rates and Mechanisms of Resistance to Imipenem and Meropenem at UPMC
Official title: Resistance Rates and Mechanisms of Resistance to Imipenem and Meropenem at UPMC to Problematic Gram-negative Organisms
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gram Negative Organism
Keywords: meropenem
imipenem
gram negative organism
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2007-03-07
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: gram negative bacteria

Brief summary: The isolate samples will be collected over a period of one year once IRB approval has been obtained. These isolates were collected as part of the patient's clinical care and once all clinical testing is complete, all isolates will be discarded. The honest broker of our area will collect the isolates and deidentify all information once all clinical testing is complete. The isolates will be obtained from the microbiology lab.

Detailed description: The study will collect two hundred pseudomonas and 20 acinetobacter baumanti consecutive bacterial isolates from microbiology. These isolates are collected as part of the patient's clinical care and are discarded once all clinical testing is complete. The honest broker will obtain these samples after all clinical testing is complete. All isolates will be deidentified. These isolates will be tested using standardized susceptibility methods for meropenem and imipenem. The activity of doripenem, a carbapenem currently being studied, and arbekacin an aminoglycoside, will also be tested. The honest broker will also collect limited patient data including underlying condition, presence of a solid organ transplant, ward location, and antibiotic history over the three months prior to organism isolation. For resistant isolates found, analytical and molecular techniques will be performed to determine the mechanisms of resistance and whether resistant isolates are coming from a single source/being transmitted from person to person.

Eligibility criteria: Inclusion Criteria:

* Samples" for the purpose of this study are Gram negative bacteria in a Petri dish of growth media.

Primary outcomes:
measure: dead or alive
timeFrame: end of study
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Brian Potoski, Pharm D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00447785: Endocrine Regulation of Energy and Fluid Supplies in Alcoholic Patients
Official title: Etude Des déterminants Endocrinologiques Des Apports énergétiques et Fluides Des Patients Alcooliques en Cours de Sevrage
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Alcoholism
Keywords: alcoholism
nutrition
craving
energy supplies
water supplies
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2007-03-15
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE

Brief summary: This study is about the endocrine regulation of energy and fluid supplies in alcoholic patients. A large proportion of energy and fluid is supplied by alcohol beverages in alcoholic patients. In this study, we evaluated the importance of these supplies with a detailed questionnaire, a nutrition software that evaluated the importance of each macro- and micronutrients and correlated these values with several hormones such as Leptin, Insulin, Cortisol, Ghrelin, and PYY involved in the regulation of energy balance or AVP involved in the regulation of plasma osmolality

Detailed description: This study was conducted in a stepwise manner : study of the energy supplies first, of water supplies next.

Interviews and samples were performed or collected at two times of alcohol withdrawal to evaluate the possibility of parallel changes in craving for alcohol, supplies and endocrine function.

Eligibility criteria: Inclusion Criteria:

* Alcoholic patients still under the effect of alcohol at entry

Exclusion Criteria:

* Other type of addiction

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques Universitaires St Luc
Study officials:
affiliation: Cliniques Universitaires St Luc, Université Catholique de Louvain
name: Roussaux Jean Paul, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00991185: Cerebrospinal Fluid (CSF) Pharmacokinetics of Antimicrobials in Children
Official title: CSF Pharmacokinetics of Antimicrobials in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infections
Keywords: Infections in Children
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2009-10-07
Enrollment: 8
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children (\<18) receiving antimicrobial agents and having cerebrospinal fluid collected as part of standard of care

Brief summary: The purpose of this study is to learn more about antimicrobials, especially drug levels in the CSF that would normally be used in young children as part of standard care. These drugs are approved by the Food and Drug Administration (FDA) for treating infections. They are used extensively in children in the United States, but they have not been extensively studied in children or babies. The investigators do not have very much information on how children and babies handle these drugs; that is, how long it takes for the drugs to be removed from the blood circulation and to pass out of the body and how much goes into the central nervous system. The investigators also do not have good information to guide how often the investigators should give the drugs to children and babies to get the maximum effect on infections with the minimum amount of drug. Thus, the investigators will collect more information about how these drugs should be used in children and babies by doing this drug levels research study.


Eligibility criteria: Inclusion Criteria:

* Children receiving antimicrobial agents and having cerebrospinal fluid collected as part of standard of care

Exclusion Criteria:

* Lack of consent

Primary outcomes:
measure: CSF:Serum Ratio of Vancomycin
timeFrame: within 1 week of drug administration
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
References:
citation: Autmizguine J, Moran C, Gonzalez D, Capparelli EV, Smith PB, Grant GA, Benjamin DK Jr, Cohen-Wolkowiez M, Watt KM. Vancomycin cerebrospinal fluid pharmacokinetics in children with cerebral ventricular shunt infections. Pediatr Infect Dis J. 2014 Oct;33(10):e270-2. doi: 10.1097/INF.0000000000000385.
Clinical trial NCT00033085: Ondansetron for the Treatment of Cocaine Dependence - 1
Official title: Double-Blind, Placebo-Controlled Trial of Ondansetron for the Treatment of Cocaine Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cocaine-Related Disorders
Drug Administration Schedule
Keywords: cocaine dependence
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: University of Texas
First posted: 2002-04-08
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
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 assess the efficacy and safety of ondansetron to reduce cocaine use in subjects with cocaine dependence.

Detailed description: Double-blind, placebo-controlled, 4-parallel group design to assess the efficacy and safety of 3 wide range doses of ondansetron to reduce cocaine use in subjects with cocaine dependence and to determine the optimal dose of ondansetron.

Eligibility criteria: Inclusion Criteria:

Male/Female, at least 18 yrs of age; DSM-4 diagnosis of cocaine dependence; seeking Treatment for cocaine dependence; have ability to understand, having understood and provide written consent; females of child bearing potential that use accepted method of birth control

Exclusion Criteria:

Additional criteria available during screening at the site.

Primary outcomes:
measure: Cocaine use
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: University of Texas Hlth Sci Ctr San Ant
state: Texas
Study officials:
affiliation: University of Texas
name: John Roache, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01355237: Observational Cohort Study of Chronic Low Back Pain
Official title: Use and Effectiveness of a Model Integrative Care Clinic in an Academic Hospital: Study II - Observational Cohort Study of Chronic Low Back Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Back Pain Lower Back Chronic
Keywords: Complementary and alternative medicine (CAM)
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Harvard Medical School (HMS and HSDM)
name: Beth Israel Deaconess Medical Center
First posted: 2011-05-18
Enrollment: 309
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The CLBP patients will be identified from two different sources at Brigham and Women's Hospital (BWH): those coming to be treated at the OCC, and those coming to non-OCC physician providers at BWH (comparison group).

Brief summary: This research study is being done to understand the outcomes of back pain treatment and costs associated with it in an academic hospital outpatient setting. The investigators will conduct a prospective observational cohort study to assess the clinical outcomes and utilization of health care services of 175 Osher Clinical Center (OCC) patients with chronic low back pain (CLBP) compared with a comparison group of 175 non-OCC CLBP patients treated within Brigham and Women's Hospital. Outcomes will include assessment of functional status, symptom relief, satisfaction with care, health-related quality of life, and worker productivity, and will be measured in person at baseline, and by phone by an interviewer blinded to cohort group at 3, 6, and 12 months.


Eligibility criteria: Inclusion Criteria:

* 3 months or more of chronic low back pain or 6 months or more of intermittent low back pain OR
* having at least one of a list of ICD-9 diagnostic codes for uncomplicated low back pain
* having two or more visits for back pain within the past two years; one of these visits must have happened within the past year (as a screening marker of chronicity)

Exclusion Criteria:

* under the age of 21
* unable to understand English
* have complicated low back pain (e.g. history of back pain related to cancer, fracture, or infection)
* unable to participate in the phone follow-up for the next one-year period.

Primary outcomes:
measure: Change in functional disability related to low back pain
timeFrame: 6 months
measure: Change in Bothersomeness of pain
timeFrame: 6 months
Secondary outcomes:
measure: Cost-effectiveness of integrative care for chronic low back pain
timeFrame: 12 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Julie E Buring, ScD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00814437: Physiological Role of KiSS-1/GPR54 System in the Human Ovary
Official title: Physiological Role of KiSS-1/GPR54 System in the Human Ovary
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Infertility
Lead sponsor: Vida Recoletas Sevilla
Sponsor class: OTHER
First posted: 2008-12-24
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy oocyte donors

Brief summary: The aim of this project is to study the physiological role of the KiSS-1/GPR54 system in the granulosa cells of the human ovary.


Eligibility criteria: Inclusion Criteria:

* Consenting oocyte donors

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Vida Recoletas Sevilla
name: Manuel Fernández-Sánchez, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01931137: A Trial Investigating the Pharmacokinetics and Pharmacodynamics of NNC0123-0000-0338 in a Tablet Formulation With Three Different Coatings in Healthy Subjects
Official title: A Trial Investigating the Pharmacokinetics and Pharmacodynamics of NNC0123-0000-0338 in a Tablet Formulation With Three Different Coatings in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2013-08-29
Enrollment: 45
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of the trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of NNC0123-0000-0338 (insulin 338) in a tablet formulation with three different coatings in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Body mass index 18.0-28.0 kg/m\^2 (both inclusive)
* Subject who is considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, ECG (electrocardiogram) and clinical laboratory tests performed during the screening visit, as judged by the investigator

Exclusion Criteria:

* Known or suspected hypersensitivity to trial products or related products
* Previous participation in this trial. Participation is defined as informed consent
* Presence of clinically significant acute gastro-intestinal symptoms (e.g. nausea, vomiting, heartburn or diarrhoea) within 2 weeks prior to first dosing, as judged by the investigator

Primary outcomes:
measure: Area under the serum insulin 338 concentration-time curve
timeFrame: From dosing to infinity calculated from a 0-288 hours NNC0123-0000-0338 serum concentration-time-curve based on 38 sampling time points.
Secondary outcomes:
measure: Area under the serum insulin 338 concentration-time curve
timeFrame: From 0 to 288 hours after a single dose (SD)
measure: Area under the glucose infusion rate (GIR)-time curve
timeFrame: From 0 to 24 hours after a single dose
measure: Number of treatment emergent adverse events
timeFrame: As recorded from trial product administration (Day 1) at Sub-visit A and until Sub-visit G (Day 13)
Other outcomes:
Locations:
city: Neuss
country: Germany
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT02405637: Simulated Amniotic Fluid In Preventing Feeding Intolerance and Necrotizing Enterocolitis VLBW Neonates
Official title: Enteral Administration of a Simulated Amniotic Fluid In Preventing Feeding Intolerance And Necrotizing Enterocolitis In Very Low Birth Weight Neonates
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Necrotizing Enterocolitis
Keywords: Feeding intolerance
Simulated amniotic fluid
Necrotizing enterocolitis
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2015-04-01
Enrollment: 40
Sex: ALL
Minimum age (years): 28
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The human fetus swallows over 200 ml of amniotic fluid per kilogram of weight each day and such swallowing is essential for normal small bowel development.Growth factors found in the amniotic fluid have been shown to promote proliferation of fetal intestinal cells. As feeding intolerance is a common problem among premature neonates, the investigators will study the role of enteral administration of simulated amniotic fluid solution in prevention of feeding intolerance and NEC in premature neonates.

Detailed description: Very Low Birth Weight (VLBW) neonates.

Participants will be followed for the duration of hospital stay until discharge or death.

Eligibility criteria: Inclusion Criteria:

* Premature infants with birth weight 1.5 Kg

Exclusion Criteria:

* Congenital or acquired anomaly of the gastrointestinal tract (i.e., omphalocele, tracheoesophageal fistula, intestinal perforation).
* Other major congenital anomalies (congenital heart disease, neural tube defect, congenital diaphragmatic hernia, trisomy, etc.).

Primary outcomes:
measure: Necrotizing enterocolitis by modified Bell criteria, mortality in percentage, hospital stay in days. The outcome measure will be assessed within 2 months
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
affiliation: ASU
name: Rania A El-Farrash, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06165237: A Study to Evaluate the Drug-drug Interaction and Safety Between "BR6001-1" and "BR6001-2"
Official title: A Phase I Clinical Trial to Evaluate the Drug-drug Interaction and Safety Between "BR6001-1" and "BR6001-2" in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Gastric or Duodenal Ulcer
Lead sponsor: Boryung Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2023-12-11
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this clinical trial is to evaluate the drug-drug interaction and safety between "BR6001-1" and "BR6001-2" in healthy adult volunteers


Eligibility criteria: Inclusion Criteria:

* Those who weigh 50 kg or more and have body mass index (BMI) within the range of 18.0 to 30.0kg/m² at screening visit.
* Those who sign written consent spontaneously to follow the study directions after listening to and understanding sufficient explanation of this clinical trial.

Exclusion Criteria:

* Those who have a medical history of gastrointestinal diseases(Crohn's disease, ulcer, acute or chronic pancreatitis, etc.) or gastrointestinal surgery (Except for simple appendectomy, hernia surgery) that may affect the absorption of investigational products.
* Those who have hypersensitivity reaction to investigational products or their additives in addition to other painkillers, anti-inflammatory drugs, antirheumatic drugs, benzimidazole.
* Those who have a history of clinically significant hypersensitivity reaction.
* Those taking anticoagulants, atazanavir, Rilpivirine and methotrexate.
* Those who eat an abnormal food that may affect the absorption, distribution, metabolism and excretion of investigational products or who eat food that may affect drug metabolism.
* Those who take any prescription drugs(including herbal medicines) that may affect characteristics of investigational product within 14 days prior to the date of first administration or who take any over-the-counter (OTC) drugs or vitamins within 10 days prior to the date of first administration (however, if it don't affect subject's safety and study's result according to the judgment of the investigator, they may participate in the study.)
* Those who take inducer and inhibitor of drug metabolizing enzymes such as barbiturates, etc. within 1 month prior to the first administration

Primary outcomes:
measure: AUCτ,ss
timeFrame: 0~24 hours after administration
measure: Cmax,ss
timeFrame: 0~24 hours after administration
measure: The change(%) of Aspirin Reaction Units(ARU) & Thromboxane B2 (TxB2) at 24h after repeated administration (last administration date) compared to baseline (first administration date)
timeFrame: 0, 6, 24 hours after administration
Secondary outcomes:
Other outcomes:
Locations:
city: Chungbuk
country: Korea, Republic of
facility: ChungBuk National University Hospital
Study officials:
References: