louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00625170: Metabolic Effects of Subchronic Dopamine D2 Receptor Blockade by Antipsychotic Drugs in Healthy Humans
Official title: Metabolic Effects of Subchronic Dopamine D2 Receptor Blockade by Antipsychotic Drugs in Healthy Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insulin Resistance
Dyslipidemia
Keywords: Antipsychotics
Olanzapine
Haloperidol
Insulin resistance
Dyslipidemia
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
Collaborators: name: Dutch Diabetes Research Foundation
First posted: 2008-02-28
Enrollment: 11
Sex: MALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: We hypothesized that short-term treatment with AP drugs induces insulin resistance through a mechanistic route that is independent of weight gain and that atypical drugs exert stronger effects than typical compounds in this respect. We therefore treated healthy non-obese men with olanzapine (atypical AP) or haloperidol (typical AP) for 8 days, and studied the impact of these interventions on glucose and lipid metabolism by hyperinsulinemic euglycemic clamp, isotope dilution technology and indirect calorimetry.


Eligibility criteria: Inclusion Criteria:

* Healthy men, with and without a positive family history of schizophrenia.
* 20 kg/m2 \< BMI \< 26 kg/m2
* Age 20-40 years
* Fasting plasma glucose \< 6 mmo/L

Exclusion Criteria:

* FPG \> 6 mmol/L
* BMI \> 26 kg/m2
* Psychiatric disorders and/or use of antipsychotic or antidepressants drugs at present or in the past.
* Any significant chronic disease
* Renal, hepatic or endocrine disease
* Use of medication known to influence lipolysis and/or glucose metabolism
* Total cholesterol \> 7mmol/L and/or triglycerides \> 2 mmol/L
* Recent weight changes or attempts to loose weight (\> 3 kg weight gain or loss, within the last 3 months)
* Difficulties to insert an intravenous catheter
* Smoking (current)
* Severe claustrophobia (ventilated hood)
* Recent blood donation (within the last 2 months)
* Recent participation in other research projects (within the last 3 months), participation in 2 or more projects in one year
* Extensive sporting activities (more than 10 hours of exercise per week)

Primary outcomes:
measure: To determine the effect of subchronic olanzapine and haloperidol treatment on HGO, whole body peripheral glucose disposal, fatty acid flux and fuel oxidation.
timeFrame: 8 days
Secondary outcomes:
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
Study officials:
affiliation: Leiden University Medical Center
name: Hanno Pijl, Phd MD
role: STUDY_CHAIR
References:
Clinical trial NCT04748770: Access to Kidney Transplant of Obese Patients Beginning Dialysis
Official title: Access to Kidney Transplant of Obese Patients Beginning Dialysis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Kidney Transplant Access
Obese Patients
Dialysis
Comorbidities
Keywords: Kidney transplant access
obese patients
dialysis
comorbidities
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2021-02-10
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be included in the study one month after the dialysis initiation. All clinical (obesity history, comorbidities, nephropathy aetiology and treatment...) and biological (nutrition markers, hemoglobin, brain natriuretic peptide (BNP)...) informations after one month and during the two years of follow-up (weight evolution, obesity complications, transplant path...) will be collected.

Brief summary: Obesity is in constant increase all over the world and affects 35% of the global population according to the World Health Organisation. It is associated with other cardiovascular risk factors (particularly hypertension and diabetes) and with high morbi-mortality. It is also responsible for an increase of the risk of developing chronic kidney diseases (CKD). In fact, obese patients represent 25% of the dialysis population and Picardy is one of the most affected areas. However, their access to kidney transplant is still restricted and the reasons are not completely understood.


Eligibility criteria: Inclusion Criteria:

* Age over 18 years old.
* Patients with BMI≥30 kg/m2 (for study population) and 25≤BMI≤30 kg/m2(for control population) one month after dialysis initiation.
* Patients agree with their data collection.

Exclusion Criteria:

* Patients with bariatric surgery history.
* Patients needed dialysis for graft dysfunction.
* Data loss.

Primary outcomes:
measure: variation of pre-transplant status two years after the obese patients' dialysis initiation between both groups
timeFrame: two years
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
References:
Clinical trial NCT00889070: Respiratory Events Among Premature Infants
Official title: Respiratory Events Among Premature Infants (32-<36 w/GA) - Outcomes & Risk Tracking Study (The REPORT Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Syncytial Virus
Lead sponsor: MedImmune LLC
Sponsor class: INDUSTRY
First posted: 2009-04-28
Enrollment: 50
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male or female preterm infants 32-≤36 wGA

Brief summary: Assess the burden of disease associated with RSV infection with premature children in an outpatient setting.

Detailed description: The primary objective of this prospective study is to assess the burden of disease associated with RSV infection, as measured/determined by rates of outpatient medically attended LRI, emergency room visits and hospitalization among preterm infants (32-≤36 wGA) during RSV season, and its medical/health consequences, as measured by wheezing events, the infant's first RSV season, up to May 2009.

Eligibility criteria: Inclusion Criteria:

* Written informed consent from parent/guardian to participate in study
* Male or female preterm infants 32-≤36 wGA
* Infant is ≤ 6month old at the time of enrollment
* Parent/guardian has the ability and willingness to follow study protocol (during the first RSV season) as required by the protocol

Exclusion Criteria:

* Receipt of any RSV prophylactic agent: palivizumab, IGIV, or motavizumab at any time prior to enrollment
* Participation in trials of investigational RSV prophylaxis or RSV therapeutic agents
* Presence of BPD or CHD (other than surgically treated PDA, ASD or VSD)
* Condition that limits life span to 6 months or less from the date of enrollment

Primary outcomes:
measure: The rate of RSV positivity and rate of outpatient and/or inpatient LRI events as well as the rate of outpatient and inpatient wheezing events.
timeFrame: Seasonal: 2008-09
Secondary outcomes:
measure: Evaluate characteristics of infants in RSV risk factor and rate and reason of attrition.
timeFrame: Seasonal: 2008-09
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Children's Primary Care Medical Group, Inc.
state: California
city: Lake City
country: United States
facility: North Florida Pediatrics
state: Florida
city: Woburn
country: United States
facility: Woburn Pediatric Associates
state: Massachusetts
city: Syracuse
country: United States
facility: Suny Upstate Medical University
state: New York
city: Cleveland
country: United States
facility: Senders Pediatrics
state: Ohio
Study officials:
affiliation: MedImmune LLC
name: Hanaa Elhefni, MD, MS, MPH
role: STUDY_DIRECTOR
References:
Clinical trial NCT03659370: Chinese Herbal Fumigation With Acupuncture for the Knee Osteoarthritis
Official title: Chinese Herbal Fumigation in Conjunction With Acupuncture for the Knee Osteoarthritis: a Three-armed Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Keywords: Osteoarthritis
Knee
Fumigation
Acupuncture
Lead sponsor: Taipei City Hospital
Sponsor class: OTHER_GOV
First posted: 2018-09-06
Enrollment: 45
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the effect of fumigation in conjunction with acupuncture for knee osteoarthritis, participators were collected from acupuncture and Chinese traumatology clinic at Linsen Chinese Medicine and Kunming Branch, Taipei City Hospital. Participators were randomized into 3 groups, one for acupuncture with fumigation, one for acupuncture with diluted fumigation, one for acupuncture only.

Detailed description: Patient population. Between June 2015 and November 2017, research subjects were recruited via poster display and clinician referral, to participate in a three-armed, randomized, controlled trial to be conducted in the Traumatology Department Linsen Chinese Medicine and Kunming Branch, Taipei City Hospital.

Eligibility criteria: Inclusion Criteria:

* Osteoarthritis of knee diagnosed by X-ray films
* According Ahlbäck System, more than stage1
* The Visual Analogue Scale of pain over 20mm in 100mm

Exclusion Criteria:

* The Visual Analogue Scale of pain less than 20mm in 100mm
* Received injection or scope treatment over knees
* Received more than 3 times of operation
* With severe inflammation (including fever, fluid, pus, gout, Rheumatic arthritis, etc.)
* With sever systemic diseases (including metastatic cancer, coronary artery disease, lung disease, etc.)
* With history of skin problem after other thermal treatment
* Under other experiments
* Women with pregnant, breastfeeding or prepare for pregnancy

Primary outcomes:
measure: Visual Analogue Scale of pain
timeFrame: This numeric measure is assed and recorded pre and post intervention at each of the study protocols bi-weekly interventions over (4) weeks, for a maximum of (8) sessions and a total of (16) measurements per individual patient.
Secondary outcomes:
measure: Questionnaire
timeFrame: This questionnaire is administered and recorded after patients have been enrolled in the trial and prior to their first intervention to establish a baseline. At the completion of the protocol's full course of treatment, bi-weekly treatment over (4) weeks
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: Linsen Chinese Medicine and Kunming Branch, Taipei City Hospital
Study officials:
affiliation: Taipei City Hospital, Linsen Chinese Medicine & Kunming Branch,
name: CHUNG-HUA HSU, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT02510170: Fetal and Maternal Head Circumference During Pregnancy in Israeli Population
Official title: Fetal and Maternal Head Circumference During Pregnancy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Maternal-Fetal Relations
Microcephaly
Keywords: Fetus
Skull
ultrasonography
Lead sponsor: Clalit Health Services
Sponsor class: OTHER
First posted: 2015-07-29
Enrollment: 188
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary care clinic

Brief summary: In this study, measurements of fetal and maternal head circumference will be collected. This data will be presented in table or graph form. The effect of maternal head circumference on fetal head circumference will be evaluated and presented in either formula or graph form.


Eligibility criteria: Inclusion Criteria:

* Singleton pregnancy
* Valid first trimester sonogram

Exclusion Criteria:

* Women under 18 years of age
* Women over 40 years of age
* Multi fetal pregnancy
* No accurate dating of pregnancy age
* Participant non compliance or cannot complete contact details
* Technical difficulty measuring fetal or maternal skull
* Abnormal fetal or maternal skull
* Familial hereditary disease, mental retardation
* Chronic maternal illness
* Maternal on chronic medication
* Abnormal screening test during current pregnancy
* Abnormal sugar metabolism or Hypertension during current pregnancy

Primary outcomes:
measure: Fetal head circumference (millimeters)
timeFrame: 14 through 40 weeks pregnancy
Secondary outcomes:
measure: Relationship of fetal head circumference (mm) to maternal head circumference (mm)
timeFrame: 14 through 40 weeks pregnancy where applicable
measure: Maternal head circumference (millimeters)
timeFrame: age 18 through 40
Other outcomes:
Locations:
city: Tel-Aviv
country: Israel
facility: Women's Health Center - Lev Tel-Aviv
Study officials:
References:
Clinical trial NCT03876470: Conquering Hepatitis C Via Micro-Elimination in Southwest Virginia
Official title: Micro-elimination of Hepatitis C in a Rural Appalachian Community: The Implementation and Expansion of an Innovative Collaborative Care Model of Telehealth and Knowledge Sharing Focusing on People Who Inject Drugs
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatitis C
Keywords: Hepatitis C
Telehealth
Injection Drug Use
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: Gilead Sciences
First posted: 2019-03-15
Enrollment: 300
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: A total of 300 subjects will be enrolled. Of these, 20 will be enrolled in the qualitative interviews and 4 will be enrolled in the ethnographic case studies.

Brief summary: The objective of this protocol is to conduct a comprehensive quantitative and qualitative assessment of the impact of our innovative collaborative telehealth HCV care model on patient treatment experiences and quality of life.

Detailed description: The investigators will evaluate the proportion of patients at each step of the HCV care cascade before and after implementation of the collaborative care model. Additionally, participants will complete questionnaires at three time points: at the initiation of hepatitis C treatment, at treatment completion, and at the assessment of sustained virologic response. Questionnaires will assess quality of life, mental health, chronic liver disease outcomes, and substance use. A subset of participants will also complete semi-structured interviews at each of the three time points. Then, a smaller subset of participants will be selected for a detailed ethnographic case study focusing on treatment experiences, quality of life, forms of social support, and illness experience.

Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Detectable HCV viral load
* Attended a clinic appointment at one of our participating sites

Exclusion Criteria:

* Cognitive disability such that informed consent cannot be obtained
* Prisoners
* Unable to understand English

Primary outcomes:
measure: Cohort-level Hepatitis C Treatment Progress
timeFrame: 12 months
Secondary outcomes:
measure: Patient Reported Quality-of-Life
timeFrame: 12 months
measure: Depression
timeFrame: 12 months
measure: Health-Related Quality-of-Life
timeFrame: 12 months
measure: Semi-Structured Qualitative Interview about Impact of HCV Treatment
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Virginia
name: Rebecca Dillingham, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00664170: A Bioequivalence Study of Docetaxel for Injectable Emulsion (ANX-514) in Patients With Advanced Cancer
Official title: A Bioequivalence Study of Docetaxel for Injectable Emulsion (ANX-514) in Patients With Advanced Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Advanced Cancer
Lead sponsor: Mast Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2008-04-22
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare an injectable emulsion form of docetaxel to Taxotere in patients with advanced cancer.


Eligibility criteria: Inclusion Criteria:

* Over 18 years old.
* Advanced cancer potentially sensitive to single agent docetaxel; ie.. locally advanced or metastatic breast cancer, locally advanced non-small cell lung cancer, hormone refractory metastatic prostate cancer, other tumor type with no standard treatment.
* ECOG performance status of 0-2 and Karnofsky Score of 100-70.

Exclusion Criteria:

* Patients who have more effective therapy available than single agent docetaxel for the malignancy.
* Pregnancy or lactation.
* Intolerance to any antineoplastic agents belonging to the taxoid family.
* Hypersensitivity to drugs formulated with polysorbate 80.
* Active infection.
* Prior anticancer therapy within 30 days prior to the first day of study treatment.
* Participation in another experimental drug study within 30 days prior to the first day of study treatment.

Primary outcomes:
measure: Pharmacokinetic equivalence of ANX-514 and Taxotere
Secondary outcomes:
Other outcomes:
Locations:
city: Muscle Shoals
country: United States
facility: Northwest Alabama Cancer Center
state: Alabama
city: La Jolla
country: United States
facility: UCSD Moores Cancer Center
state: California
city: Middletown
country: United States
facility: Signal Point Hematology/Oncology Inc.
state: Ohio
city: Buenos Aires
country: Argentina
facility: Hospital Universitario Austral
state: Provincia de Buenos Aires
city: Rosario
country: Argentina
facility: Centro Oncologico de Rosario
state: Santa Fe
city: Concepcion
country: Argentina
facility: Hospital Regional de Concepcion
state: Tucuman
city: Buenos Aires
country: Argentina
facility: Marcelo T de Alvear
city: Mendoza
country: Argentina
facility: Centro Oncologico de Integracion Regional
city: Salta
country: Argentina
facility: Hospital Privado Santa Clara de Asis
city: Santa Fe
country: Argentina
facility: Isis Centro Especializado
city: Tucuman
country: Argentina
facility: Centro Medico San Roque
city: Tallinn
country: Estonia
facility: Tallinn Cancer Clinic
city: Tartu
country: Estonia
facility: Tartu University Hospital, Clinic of Hematology and Oncology
Study officials:
affiliation: Mast Therapeutics, Inc.
name: Jeff Stewart, MBA
role: STUDY_DIRECTOR
References:
Clinical trial NCT01128270: Pharmacotoxicology of Trichloroethylene Metabolites
Official title: Pharmacotoxicology of Trichloroethylene Metabolites Aim 3
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Healthy
Keywords: Dichloroacetate
Chloral Hydrate
Metabolism
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2010-05-21
Enrollment: 27
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

Brief summary: This is a research study to look at how Dichloroacetate (DCA), and investigational drug and chloral hydrate are broken down in the body. The purpose of the study is to better understand how humans metabolize these two common chemicals that are widely present in the environment. The study focuses on how the drug chloral hydrate is broken down and how it effects DCA

Detailed description: The subject's general health is assessed by a history and physical exam and routine blood work. I normal the individual undergoes five nights of receiving 1.5ug/kg of chloral hydrate. On day 6 the individual receives 2.5 micrograms/kg of Dichloroacetate (DCA) and kinetics are drawn. After 30 days the subject comes back and receives 1.5ug/kg of chloral hydrate for five nights and has kinetics drawn on night one and five. On days 6-9 the subject returns for a blood draw. After 30 days the same process as above is done except the subject receives 1gram of chloral hydrate for five nights and 25mg/kg of Dichloroacetate one day then 30 days later the subject receives 1gram of chloral hydrate for five nights and has kinetics done on night one and five and blood samples drawn on days 6-9

Eligibility criteria: Inclusion Criteria:

* healthy
* normal screening labs

Exclusion Criteria:

* no gastrointestinal surgery
* no smoking
* no medication
* not pregnant

Primary outcomes:
measure: Plasma DCA (Microgram/ml) After 5 Days of Therapeutic Level Chloral Hydrate on Arm 2A.
timeFrame: 6 Days
measure: Difference in Half Lives 5 Day Less One Day Exposure in Trichloroacetate
timeFrame: 5 days
measure: Urinary Maleylacetone Levels After 5 Day Exposure to Therapeutic Chloral Hydrate (Arm 2B)
timeFrame: 5 days
Secondary outcomes:
measure: Detectable DCA After Day 1 in Serum (0=No 1=Yes)
timeFrame: 1 day
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida College of Medicine
state: Florida
Study officials:
affiliation: University of Florida
name: Peter W. Stacpoole, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References: