louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00004312: Establishment of a Database for Long-Term Monitoring of Patients With Nephropathic Cystinosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystinosis
Keywords: cystinosis
rare disease
renal and genitourinary disorders
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: University of California, San Diego
First posted: 1999-10-19
Enrollment: 400
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: OBJECTIVES: I. Establish a computerized databank to monitor the progress of patients with cystinosis treated with cysteamine.

II. Track and monitor all patients including renal transplant, dialysis and post renal transplants.

Detailed description: PROTOCOL OUTLINE:

Data are collected from patients and physicians. Information includes disease, treatment, family history, demographic, and physical exam data. The dates of kidney transplantation and/or dialysis initiation are also recorded.

Eligibility criteria: PROTOCOL ENTRY CRITERIA:

Nephropathic cystinosis diagnosis by white-cell cystine measurement, including infantile and late-onset forms

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California San Diego School of Medicine
state: California
Study officials:
affiliation: University of California, San Diego
name: Jerry A. Schneider
role: STUDY_CHAIR
References:
Clinical trial NCT03193112: Melatonin Decreases Eye Pressure in Normotensive Patients
Official title: Melatonin Decreases Eye Pressure in Depressive Patients With Normal Intraocular Pressure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depressive Disorder
Keywords: Agomelatine
Depression
Intraocular pressure
Lead sponsor: Kahramanmaras Sutcu Imam University
Sponsor class: OTHER
First posted: 2017-06-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 66
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Investigators seek to analyze the intraocular pressure changes depending on Agomelatin treatment. Depressive patients who are deemed suitable for agomelatine treatment on a routine basis by psychiatry clinic will be monitored with regard to intraocular pressure changes. Treatment decision will be given by the psychiatrist independently from patient's enrollment to the study. Then, investigators will measure intraocular pressure before the treatment and one month after the treatment.

Brief summary: Agomelatine is a melatonin drug used to treat depressive disorder. Agomelatine may also some effects on ocular pressures. In this study, we aimed to demonstrate that melatonin decreases intraocular pressures when given depressive patients.

Detailed description: Melatonin has been shown to be effective to decrease intraocular pressure in experimental animal researches. Agomelatine is a melatonin derivative drug approved for the treatment of depression, which is also available in our country. Depending on animal experiments, it can be assumed that agomelatine can decrease intraocular pressure. Demonstrating that agomelatine is effective to reduce eye pressure may give a concurrent treatment of depressive patients with glaucoma. With this it may be possible to treat both diseases at the same time with single drug. In this study, the researchers intended to investigate the changes in ocular tension in normotensive depressive patients treated with agomelatine.

Eligibility criteria: Inclusion Criteria:

* Depressive patients suitable for Agomelatine therapy for the treatment of their primary disease.

Exclusion Criteria:

- Any past history of ocular surgery, ocular trauma or existing ocular diseases

Primary outcomes:
measure: Intraocular pressure
timeFrame: One month
Secondary outcomes:
Other outcomes:
Locations:
city: Kahramanmaraş
country: Turkey
facility: Kahramanmaras Sutcuimam University Ophthalmology Department
Study officials:
affiliation: KSU
name: Gokhan Ozdemir, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00184912: The Effect of Caffeine on Ischemic Preconditioning
Official title: Caffeine Reduces Acute Ischemic Preconditioning
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caffeine
Ischemic Preconditioning
Ischemia-Reperfusion Injury
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: ZonMw: The Netherlands Organisation for Health Research and Development
First posted: 2005-09-16
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Ischaemic preconditioning (IP) describes the phenomenon that brief periods of ischaemia render the (myocardial) muscle more resistant to a subsequent more prolonged period of ischaemia and reperfusion. Animal studies have provided evidence that adenosine receptor stimulation is an important mediator of IP. As caffeine is an effective adenosine receptor antagonist already at concentrations reached after regular coffee consumption, we aimed to assess whether caffeine impairs IP in humans in vivo. We used a novel and well-validated model to study IP in humans: 99m-Tc-annexin A5 scintigraphy in forearm skeletal muscle.

24 healthy volunteers were randomly assigned to either caffeine (4 mg/kg/iv in 10 minutes) or saline before a protocol for IP.


Eligibility criteria: Inclusion Criteria:

* healthy male volunteers

Exclusion Criteria:

-

Primary outcomes:
measure: Percentual difference in Annexin A5 targetting between the experimental and control arm one and four hours after intravenous injection.
Secondary outcomes:
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Centre / Department of Pharmacology and Toxicology
state: Gelderland
Study officials:
affiliation: Radboud University Nijmegen Medical Centre / Department of pharmacology and Toxicology
name: Gerard Rongen, MD, Phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rongen GA, Oyen WJ, Ramakers BP, Riksen NP, Boerman OC, Steinmetz N, Smits P. Annexin A5 scintigraphy of forearm as a novel in vivo model of skeletal muscle preconditioning in humans. Circulation. 2005 Jan 18;111(2):173-8. doi: 10.1161/01.CIR.0000151612.02223.F2. Epub 2004 Dec 27.
citation: Riksen NP, Zhou Z, Oyen WJ, Jaspers R, Ramakers BP, Brouwer RM, Boerman OC, Steinmetz N, Smits P, Rongen GA. Caffeine prevents protection in two human models of ischemic preconditioning. J Am Coll Cardiol. 2006 Aug 15;48(4):700-7. doi: 10.1016/j.jacc.2006.04.083. Epub 2006 Jul 24.
Clinical trial NCT01596712: Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of QGE031 in Japanese Atopic Male Subjects
Official title: A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity Following Subcutaneous Injections of QGE031 in Japanese Atopic Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Allergy
Keywords: Allergy,
Asthma,
Atopic dermatitis,
Japanese,
QGE031,
IgE
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2012-05-11
Enrollment: 209
Sex: MALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of QGE031 in Japanese atopic male subjects in order to determine the eligibility of Japanese patients in subsequent clinical studies.


Eligibility criteria: Inclusion Criteria:

* Male Japanese subjects who are atopic as determined by an in vitro test (CAP-RAST or MAST test)
* Serum IgE level must be equal to or greater than 30 IU/mL at screening.

Exclusion Criteria:

* Poorly controlled asthma i.e. symptoms of asthma (daytime or night-time) or use of short-acting beta agonist for relief of asthma (except with exercise) more than once a week
* Worsening of asthma signs and symptoms prompting a medical intervention within 1 year prior to dosing
* Severe atopic dermatitis within 1 year prior to dosing, defined by a history of eruption with severe inflammation such as erythema, papule, erosion, infiltration and lichen
* Severe allergic rhinitis strongly disturbing daily life within 1 year prior to dosing
* Severe allergic conjunctivitis (e.g., episodes of giant papillary, limbal proliferation, shield ulcer) within 1 year prior to dosing
* Prior use of Xolair® or other anti-IgE antibodies
* Concomitant use of allergy vaccination therapy

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Number of Patients with Adverse Events
timeFrame: Day 113
Secondary outcomes:
measure: QGE031 serum concentration
timeFrame: Pre-dose, 2, 4, 12, 24, 48, and 96 h post-dose, Days 8, 15, 22, 29, 43, 57, 71, 85, 99 and 113
measure: Free and total IgE serum concentrations
timeFrame: Pre-dose, 2, 4, 12, 24, 48, and 96 h post-dose, Days 8, 15, 22, 29, 43, 57, 71, 85, 99 and 113
measure: FcεRI expression and IgE binding on basophiles
timeFrame: Pre-dose, 2, 24, 48, 96 h post-dose; Days 8, 15, 22, 29, 43, 57, 71, 85, 99, and 113
measure: Immunogenicity (Anti-QGE031 antibody in serum)
timeFrame: Pre-dose, Days 29, 57 and 113
Other outcomes:
Locations:
city: Sagamihara
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT01144312: Population Pharmacokinetics of Fentanyl in Patients Undergoing Living Donor Liver Transplantation
Official title: Population Pharmacokinetics of Fentanyl in Patients Undergoing Living Donor Liver Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Living Donor Liver Transplantation
Keywords: LDLT
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
Collaborators: name: Ministry of Health & Welfare, Korea
First posted: 2010-06-15
Enrollment: 20
Sex: ALL
Minimum age (years): 19
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 aim of this study was to characterize pharmacokinetics of fentanyl during and after Living Donor Liver Transplantation (LDLT), using population pharmacokinetic analysis with non linear mixed effects modeling.

Detailed description: Patients received an initial intravenous bolus of fentanyl 100 μg and infused at variable rates ranging from 250 to 400 μg/hr.

Arterial blood samples (3ml) were taken immediately before the start of infusion (baseline), and at scheduled time which were coincident with laboratory tests during surgery as follows. In pre-anhepatic phase, blood were taken at 10min, 30min, 1hr, 3hr, 5hr until clamping of the hepatic blood supply and venous drainage, after the star of anhepatic phase, blood were taken at 5 min, 10 min, 30 min, 60 min, 90 min, 2hr until the vessels were reconnected to new liver. In neo-hepatic phase, blood were taken at 5min, 10min, 30min, 60min, 90min, 2hr, 3hr, 5hr until fentanyl-infusion stop, and at 0hr, 1hr, 3hr, 5hr, 8hr, 12hr, 24hr immediately after the stop of infusion. Samples were collected into tubes containing heparin as an anticoagulant and immediately placed on ice. After centrifugation for 8 min at 1800 g, the plasma was transferred to a cryovial and stored at -70°C until assay.

Eligibility criteria: Inclusion Criteria:

* Patients between 19 - 65 years of age
* Over 45kg of weight
* Written Informed consent
* Patients receiving a liver graft from living donor (ASA PS III or IV)

Exclusion Criteria:

* Patients with renal dysfunction
* Patients with Fulminant hepatic failure
* Patients participated other clinical trials within 2 months
* Unable or Unwilling to give informed consent
* Abnormal test results with clinical significance

Primary outcomes:
measure: pharmacokinetic parameters of fentanyl during LDLT
timeFrame: 48 Hours (during anesthesia of LT and after infusion stop)
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
References:
Clinical trial NCT04940481: TROLLEY Study - TRansit Opportunities for HeaLth, Livability, Exercise and EquitY
Official title: TROLLEY Study - TRansit Opportunities for HeaLth, Livability, Exercise and EquitY
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Physical Activity
Keywords: active travel, equity, commute mode
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2021-06-25
Enrollment: 479
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We will study UCSD staff. We will aim to recruit 50% from people of color, and 50% low income (\<80% Area Median Income), 50% female, and 50% living within 1 mile of a transit stop that connects to the Mid-Coast Trolley.

Brief summary: The researchers are evaluating longitudinal changes in multiple health, economic, and environmental outcomes over a 3-year COVID recovery period and in the context of a new light rail transit (LRT) line, called the Mid-Coast Trolley, among 465 UC San Diego (UCSD) staff. The primary aim is to evaluate change in objectively measured total and moderate to vigorous physical activity (MVPA), travel mode, and vehicle miles traveled (VMT).


Eligibility criteria: Inclusion Criteria:

1. are 18 years of age or older;
2. are a full or part-time employee at UC San Diego
3. Prior to COVID-19, you used to commute to La Jolla at least 2 days per week;
4. have lived in the neighborhood selected for the study for at least one year;
5. are able to walk without human assistance;
6. are comfortable reading and writing in English or Spanish;
7. have a reliable phone where you can be reached;
8. spend most of your time in San Diego County;
9. don't plan on moving in the next year;
10. are able to give informed consent and comply with the protocol;
11. are willing to complete all assessments and wear all devices for 7 days at 3 different time points in the next 2 years.

Exclusion Criteria:

1) pregnant, 2) mental state that would preclude understanding the protocol, 3) medical condition that would affect physical activity, 4) taking part in another physical activity related research study, and 5) live or regularly travel outside of San Diego County.

Primary outcomes:
measure: Moderate to vigorous physical activity
timeFrame: 2 years
Secondary outcomes:
measure: Active commute mode
timeFrame: 2 years
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UC San Diego
state: California
Study officials:
References:
citation: Crist K, Benmarhnia T, Frank LD, Song D, Zunshine E, Sallis JF. The TROLLEY Study: assessing travel, health, and equity impacts of a new light rail transit investment during the COVID-19 pandemic. BMC Public Health. 2022 Aug 2;22(1):1475. doi: 10.1186/s12889-022-13834-1.
Clinical trial NCT01448681: A Continuous, Non-Invasive, Real-time Method for Estimating and Predicting Intracranial Hypertension
Official title: A Continuous, Non-Invasive, Real-time Method for Estimating and Predicting Intracranial Hypertension
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intracranial Hypertension
Elevated ICP (Intracranial Pressure)
Keywords: Intracranial Hypertension
Elevated ICP (Intracranial Pressure)
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2011-10-07
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Surgical intensive care unit patients

Brief summary: There is statistically significant correlation between invasive measures of intracranial pressure (ICP) and non-invasive, real-time, continuous physiologic waveform data algorithms to predict ICP. Furthermore, characteristics within this physiologic waveform data will allow modeling for trend prediction of derived ICP information. Specific aims:

1. Develop models to estimate ICP and cerebral perfusion pressure (CPP) after traumatic brain injury in humans.
2. Predict and anticipate changes in ICP for preemptive management purposes.
3. Analyze characteristics of changes in ICP after treatment failure.
4. Analyze data to predict/anticipate confounding physiologic factors that affect ICP and its treatment.
5. Test the resulting models in real time.


Eligibility criteria: Inclusion Criteria:

* patients with severe traumatic brain injury resulting in motor Glasgow Coma Score (GCS) score \< 5
* age 18-89 years
* health care provider indicating the need for hyperosmolar therapy for elevated ICP

Exclusion Criteria:

* pregnancy
* incarceration
* brain death (GCS 3 with fixed, dilated pupils)
* life-threatening systemic injuries (Abbreviated Injury Scale (AIS) \>4 in an organ system other than CNS)

Primary outcomes:
measure: Algorithm development
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: Denver Health Medical Center
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Steven Moulton, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01800981: Functionality Assessments in Patients (Adults and Children) Following Treatment With Debrase Compared to Standard of Care
Official title: Functionality Assessments in Patients (Adults and Children) Following Treatment With Debrase Compared to Standard of Care (SOC) Protocol MW2012-12-12
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Burns, Upper Extremity
Burns, Lower Extremity
Keywords: Functionality
extremities
ROM
Upper and lower Extremity for burned patients
Lead sponsor: MediWound Ltd
Sponsor class: INDUSTRY
First posted: 2013-02-28
Enrollment: 53
Sex: ALL
Minimum age (years): 10
Maximum age (years): 61
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adults and children who had participated and completed study MW2004-11-02 (previous phase 3 study) will be contacted. Patients who will agree to participate in the study will be invited to the clinic for a one day visit for assessments.

Brief summary: Once the victim survived the acute phase, the outcome of wound healing, the scarring, became a major medical issue with complications that may lead to cosmetic and functional sequelae. Scar tissue is clinically distinguished from normal skin by an aberrant color, rough surface texture, increased thickness (hypertrophy), contraction, firmness and sometimes, decrease function.

Thus, functional and cosmetic outcomes became at least important as wound closure in assessing wound healing products

Detailed description: This is a multi-center, assessor-blinded study aiming to evaluate the long term functionality in adults and children who have participated in study MW2004-11-02 (previous phase 3 study).

We had previously shown that by using the MVSS scale which includes objective assessment of the physical characteristics of size, shape, volume, color, texture, and pliability as well as structural, mechanical and physiologic characteristics, lower (favorable) scores in Debrase vs. SOC group were observed in sub-groups of highly functional body parts of the hands and feet. This study will include specific functionality evaluation using the "Lower Extremity Functional Scale" test for burns in the lower extremities and the "QuickDASH" outcome measure for burns in the upper extremities as well as range of motion measurements of the joints (knee, ankle, shoulder, elbow and wrist, as relevant).

Eligibility criteria: Inclusion Criteria:

* Adults and children who had participated and completed study MW2004-11-02. Patients must be able to sign and dated written informed consent prior to study entry (by Patient or by a guardian, when applicable).

Exclusion Criteria:

* None

Primary outcomes:
measure: Functionality evaluation using self reported questionnaires and ROM measurements
timeFrame: 2-5 years following to acute treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Kosice
country: Slovakia
facility: Clinic of Burns and reconstructive surgery hospital
Study officials:
affiliation: Department Head of Burs and Reconstructive Surgery
name: Jan Koller, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03064581: A Pap Test Intervention to Enhance Decision Making Among Pacific Islander Women
Official title: A Pap Test Intervention to Enhance Decision Making Among Pacific Islander Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Cancer
Keywords: Cervical Cancer
Screening
Pap Test
Pacific Islander Americans
Lead sponsor: California State University, Fullerton
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2017-02-27
Enrollment: 1014
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This community-based randomized trial tested the effects of a social support intervention to increase Chamorro, Samoan, and Tongan women's Pap test behavior and social support among their male spouses or significant others in Southern California.

Detailed description: The purpose of this five-year community-based randomized trial was to: 1) examine the Pap test decision making process in Pacific Islander women; 2) assess the role of social support within the decision making process; and 3) develop and test an intervention to increase Pap testing among Pacific Islander women, and support among their male spouses/significant others. The intervention was created utilizing a Multi-Attribute Utility model and social support theory resulting in gender-specific educational workshops consisting of a social support intervention that informed both Pacific Islander women and men about cervical cancer and the importance of Pap testing for Pacific Islander women, and aimed to increase social support among their male spouses/significant others.

Eligibility criteria: Inclusion Criteria:

* Women ages 21 to 65
* Of Chamorro, Samoan, and/or Tongan ethnicity
* Has a significant other (married or in a long-term relationship for more than 5 years).

Exclusion Criteria:

* Not a member of one of the churches or clans visited for recruitment

Primary outcomes:
measure: Change in receipt of a Pap test
timeFrame: Assessed at baseline and 6-month follow-up
Secondary outcomes:
measure: Change in knowledge of cervical cancer risk factors
timeFrame: Assessed at baseline and 6-month follow-up
measure: Change in fatalistic attitudes towards cancer
timeFrame: Assessed at baseline and 6-month follow-up
measure: Change in perceived social support
timeFrame: Assessed at baseline and 6-month follow-up
measure: Scheduled a Pap test
timeFrame: Assessed at 6 month follow-up
Other outcomes:
Locations:
city: Fullerton
country: United States
facility: California State University, Fullerton
state: California
Study officials:
affiliation: California State University, Fullerton
name: Sora Park Tanjasiri, DrPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Guam Communications Network
name: Lola Sablan-Santos
role: PRINCIPAL_INVESTIGATOR
References: