louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01523054: Metoprolol in Acute Myocardial Infarction. A PK/PD Study
Official title: A Pharmacokinetic and Pharmacodynamic Study Comparing Metoprolol IR and Metoprolol CR/XL Subsequent to Initial Treatment With Intravenous and/or Oral Metoprolol in Patients With Suspected Acut Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acute Myocardial Infarction
Keywords: metoprolol, acute myocardial infarction, pharmacokinetics, pharmacodynamics
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2012-02-01
Enrollment: 27
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The objective of the study was to compare treatment with two different oral formulations of metoprolol, metoprolol immediate release (IR) and metoprolol extended release (CR/XL) in patients with acute myocardial infarction regarding the following:

Pharmacokinetics, peak and trough plasma concentrations and area under the plasma concentration curve.

Pharmacodynamics, hourly means of Holter recorded heart rate. Tolerability. An open, randomised design with two parallel groups was employed.

Detailed description: A pharmacokinetic and pharmacodynamic study comparing metoprolol IR and metoprolol CR/XL subsequent to initial treatment with intravenous and/or oral metoprolol in patients with suspected acut myocardial infarction

Eligibility criteria: Inclusion Criteria:

* Male and female patients admitted to the CCU with suspected acute myocardial infarction
* Age 18 years or older
* Treated with and tolerated the full dose of metoprolol IR 50 mr four times daily or metoprolol CR/XL 200 mg once daily on study day 1
* Expected to stay in the CCU until the morning of study day 4
* Sinus rhythm on the day of admission and at randomisation

Exclusion Criteria:

* Pregnancy or childbearing potential without adequate contraception
* Participation in a clinical study during the last 30 days or previous randomisation in the present study

Primary outcomes:
measure: Pharmacokinetic profile in terms of Cmax, Cmin, AUC
timeFrame: Treatment duration: 4 days
measure: Pharmacodynamics in terms of Hourly means of heart rate (Holter recorded)
timeFrame: Treatment duration: 4 days
measure: Safety profile in terms of adverse events
timeFrame: Treatment duration: 4 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: AstraZeneca R&D Mölndal
name: Dag Elmfeldt, MD, PHD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02430454: Impact of Bed Availability and Cognitive Load on Intensive Care Unit Bed Allocation: a Vignette-based Clinical Trial
Official title: Vignette-based Randomized Controlled Trial of the Decision Making Process of Bed Allocation in the Intensive Care Unit: Impact of Bed Availability and Cognitive Load.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: There Are no Specific Conditions Under Study
This Study Evaluates the Clinical Decision-Making Associated With Intensive Care Units Rationing
Keywords: ICU
decision making
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2015-04-30
Enrollment: 178
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Decisions about ICU beds allocations are made everyday, specially in countries with scarcity of ICU beds, such as Brazil. ICU triage, most of the time, is not structured, which may lead to faulty decision making, possibly leading to bad clinical outcomes. It has been shown that external factors may influence the decision making process. The investigators intend to evaluate the impact of bed availability and cognitive load on the ICU bed allocation process by submitting groups of individuals to a vignette based randomized controlled trial simulating conditions with or without increased cognitive load and conditions with or without scarcity of ICU beds.

Detailed description: Vignettes will be constructed based on consecutive patients for whom ICU bed was solicited. Vignettes will be validated through the evaluation of 8 experts in situations with or without bed scarcity. Vignettes with more than 80% concordance on ICU disposition (admission or refusion) will be used in the trial.

Intensive care doctors in Brazil will be asked to answer an online questionnaire with demographic characteristics and randomized to one of two groups. The experimental group will be submitted to increased cognitive load conditions, meaning that they will be encouraged to give their first impression on the vignettes, will have a time limit to answer the questions and will have popups with sound and videos, with the purpose to distract the respondents. The control group will be encouraged to think thoroughly and will have no time limit or distractions.

Vignettes will be presented, randomly, in conditions with or without scarcity of ICU beds to both groups. So, respondents with and without increased cognitive load will evaluate vignettes in conditions with and without scarcity of ICU beds.

Eligibility criteria: Inclusion Criteria:

* Intensive care unit doctors participating in specialty email lists

Exclusion Criteria:

* Consent not provided

Primary outcomes:
measure: simulated ICU admission rates
timeFrame: 24 hours
Secondary outcomes:
measure: Time to complete the questionnaire
timeFrame: 60 minutes
Other outcomes:
Locations:
Study officials:
affiliation: Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
name: Joao G Ramos, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00228254: Vitamin A and Zinc: Prevention of Pneumonia (VAZPOP) Study
Official title: Vitamin A and Zinc: Prevention of Pneumonia (VAZPOP) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pneumonia
Diarrhea
Acute Upper Respiratory Tract Infections
Keywords: acute respiratory infection
acute lower respiratory infection
diarrhea
Lead sponsor: Tufts University
Sponsor class: OTHER
Collaborators: name: Corporacion Ecuatoriana de Biotecnologia
First posted: 2005-09-28
Enrollment: 2582
Sex: ALL
Minimum age (years): 6
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: Children with malnutrition are often low in some nutrients, like zinc or vitamin A, that could help them fight off infections like pneumonia. Our study was designed to see if children who got supplements of zinc or vitamin A had fewer infections.

Detailed description: The Vitamin A and Zinc: Prevention of Pneumonia (VAZPOP) study was a multi-year nutritionally-stratified, placebo-controlled, double-blind study of low-dose vitamin A and/or zinc in 2,582 normal and malnourished urban children aged 6 to 36 months in Quito, Ecuador. Four group of \~ 645 children were enrolled in 2000, 2001, 2002, and 2003 with each child participating for up to 50 weeks. Children were visited 4 days each week. Outcome measures were pneumonia, other respiratory tract infections, diarrheal disease, and growth.

Eligibility criteria: Inclusion Criteria:

Age 6 to 36 months at the time of enrollment No recent vitamin or micronutrient use Residence of 1 year or longer in the neighborhood Full and free written consent No clinical evidence of zinc or vitamin A deficiency Absence of severe malnutrition such as weight \< or = to 60% of expected weight

-

Exclusion Criteria:

Age less than 6 months or greater than 36 months at enrollment Recent vitamin or micronutrient use Residence for less than 1 year in neighborhood Lack of full and free consent Any evidence of zinc or vitamin A deficiency Severe malnutrition

Primary outcomes:
measure: Incidence of acute lower respiratory infection (pneumonia)
measure: Growth
Secondary outcomes:
measure: Additive or synergistic effects of zinc and vitamin A
measure: Incidence of diarrheal disease
measure: Incidence of other respiratory infections
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts University School of Medicine
state: Massachusetts
city: Quito
country: Ecuador
facility: Corporacion Ecuatoriana de Biotecnologia
state: Pinchincha
Study officials:
affiliation: Tufts University School of Medicine
name: Jeffrey K Griffiths, MD MPH&TM
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00002154: A Study of Thioctic Acid and Deprenyl in HIV-Infected Patients With Dementia
Official title: Parallel Group, Placebo-Controlled, Tolerability and Safety Study of Thioctic Acid and Deprenyl in HIV Dementia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cognitive Disorders
HIV Infections
Keywords: Drug Therapy, Combination
Cognition Disorders
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Thioctic Acid
Selegiline
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see if it is safe and effective to give thioctic acid and deprenyl (selegiline hydrochloride), alone or in combination, to HIV-infected patients who have mild to moderate dementia (a decline in their mental abilities).

Detailed description: Patients are randomized to receive thioctic acid alone, deprenyl alone, thioctic acid/deprenyl, or placebo alone for 10 weeks, after which all patients may receive active drug on an open-label basis. Patients must have seven clinic visits.

Eligibility criteria: Inclusion Criteria

Concurrent Medication:

Allowed:

* Antiretrovirals provided dose has been stable for at least 6 weeks prior to study entry.

Patients must have:

* HIV seropositivity.
* Mild to moderate cognitive impairment (problems with short term memory, concentration, and feeling slowed down).
* No active opportunistic CNS infection.
* Ability to give informed consent.

Prior Medication:

Allowed:

* Prior antiretrovirals provided dose has been stable for at least the past 6 weeks.
* Prior thioctic acid or deprenyl.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Severe premorbid psychiatric illness including schizophrenia and major depression that would interfere with study compliance.
* CNS neoplasms.
* Any other clinically significant condition or laboratory abnormality that would preclude participation on study.
* Current participation in other drug studies.

Concurrent Medication:

Excluded:

* Chemotherapy for malignancy.

Patients with the following prior conditions are excluded:

* History of chronic neurological disorders such as serious head injury, documented stroke, multiple sclerosis, uncontrolled epilepsy, Tourette's syndrome, and other neurodegenerative processes such as Huntington's disease.
* Prior participation in this study.
* History of adverse reaction/allergy to thioctic acid or deprenyl.

Prior Medication:

Excluded:

* Other investigational drugs within 30 days prior to study entry.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hosp
state: Maryland
city: New York
country: United States
facility: Columbia Univ
state: New York
city: Rochester
country: United States
facility: Univ of Rochester Med Ctr
state: New York
Study officials:
References:
Clinical trial NCT02691754: Impact of a Free Distribution of Paracetamol to Osteoarthritic Patients on Non-steroidal Anti-inflammatory Drugs (NSAID) and Proton Pump Inhibitors (PPI) Prescription
Official title: A Cluster Randomised Trial to Measure the Impact of a Free Distribution of Paracetamol to Osteoarthritic Patients on Non-steroidal Anti-inflammatory Drugs (NSAID) and Proton Pump Inhibitors (PPI) Prescription
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis
Keywords: Paracetamol
PPI
Opioids
NSAID
Drug Prescription
Lead sponsor: Azienda USL Reggio Emilia - IRCCS
Sponsor class: OTHER_GOV
First posted: 2016-02-25
Enrollment: 16
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Paracetamol is recommended as first line treatment for pain control in osteoarthritis, but it is not included in list of drugs than can be prescribed in charge of National Health System by General Practitioners. The hypothesis is that removing this economical barrier the investigators can decrease the prescription of NSAID and of the Proton Pump Inhibitors (PPI), often given for gastric bleeding prophylaxis in NSAID chronic users. As secondary outcome, opioids use was also monitored to see.

Aim of the study is to test if allowing prescription of free paracetamol decreases the prescription of NSAID in osteoarthritic patients.

Detailed description: The trial was conducted in two primary care units of the province of Reggio Emilia. The units have about 34.000 inhabitants. In this units 16 General Practitioners are active, the average beneficiaries per General Practitioner are 1500, about one fourth over 65 years old.

Eligibility criteria: Inclusion Criteria:

* Patients with osteoarthritis assisted by a General Practitioners working in Reggio Emilia Province who agreed to participate in the study

Exclusion critera:

- none

Primary outcomes:
measure: Consumption of NSAID
timeFrame: one year
Secondary outcomes:
measure: Consumption of PPI
timeFrame: one year
measure: Consumption of opioids
timeFrame: one year
Other outcomes:
Locations:
Study officials:
affiliation: Inter-Institutional Pharmaceutical Department, Local Health Authority, Reggio Emilia, Italy
name: Alessandra Ferretti, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vicentini M, Mancuso P, Giorgi Rossi P, Di Pede S, Pellati M, Gandolfi A, Zoboli D, Ricco D, Busani C, Ferretti A. A cluster randomized trial to measure the impact on nonsteroidal anti-inflammatory drug and proton pump inhibitor prescribing in Italy of distributing cost-free paracetamol to osteoarthritic patients. BMC Fam Pract. 2019 Dec 6;20(1):169. doi: 10.1186/s12875-019-1050-4.
Clinical trial NCT03714854: Study of Motor Control Mechanisms in DBS-implanted Parkinson's Disease Patients
Official title: Study of Motor Control Mechanisms in DBS-implanted Parkinson's Disease Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2018-10-22
Enrollment: 6
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Akinesia is one of the most prominent symptom in Parkinson's Disease (PD) patients. It typically consists in a inability to initiate voluntary movement, and it affects patients' quality of life. This study aims at exploring the influence of Deep Brain Stimulation (DBS) in the quality of motor control, and particularly of voluntary movement initiation, and its neural correlates. They will be evaluated using behavioral and motor tasks together with Transcranial Magnetic Stimulation (TMS) and electrophysiology (EMG and EEG).


Eligibility criteria: Inclusion Criteria:

* PD patients that are monitored for the tuning of their DBS stimulator by Grenoble's Hospital.
* PD patients that are hospitalized for the tuning routine 12 months after the surgical implantation.
* Good tolerance following temporary stops of the DBS stimulator
* Affiliated to a social security system
* Mental abilities sufficient for performing the behavioral tasks (MMSE score \>= 24, tested less than 6 months ago)

Exclusion Criteria:

* Patients that are concerned by articles L1121-5, L1121-6, L1121-7 and L1121-8 of French Code de la Santé Publique,
* History of psychiatric or neurological illness other than PD
* Patients that are currently excluded from an other clinical trial
* Contraindications for TMS practice
* Inability to stay seated without pain for two hours
* Pregnancy

Primary outcomes:
measure: Corticospinal excitability
timeFrame: 60 minutes
Secondary outcomes:
measure: Cortical excitability
timeFrame: 60 minutes
measure: Cortico-subcortical connectivity
timeFrame: 20 minutes
measure: Correlation between behavioral and neural responses
timeFrame: 60 minutes
Other outcomes:
Locations:
city: Grenoble
country: France
facility: CHU de GRENOBLE ALPES
Study officials:
References:
Clinical trial NCT00528554: Laser Acupuncture Against Nausea in Children
Official title: Laser Acupuncture to Alleviate Nausea and Vomiting in Children and Adolescents Receiving Highly Emetogenic Chemotherapy. A Prospective, Double-Blinded, Placebo-Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nausea
Vomiting
Cancer
Keywords: CINV
chemotherapy induced nausea and vomiting (CINV)
Lead sponsor: University Children Hospital Homburg
Sponsor class: OTHER
Collaborators: name: University Hospital Tuebingen
First posted: 2007-09-12
Enrollment: 25
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: To investigate whether nonthermal low level laser acupuncture has beneficial effects on nausea and vomiting in children receiving highly emetogenic chemotherapy for a malignant solid tumor. In a previous crossover study comparing needle acupuncture to no intervention in an otherwise similar setting we found beneficial effects, but this trial was not even single-blinded and therefore the results are questionable. The hypothesis is that active laser acupuncture is more effective than placebo laser acupuncture concerning episodes of retching/vomiting (primary outcome measure) and rescue antiemetic medication (secondary outcome measure) with a fix standard antiemetic medication


Eligibility criteria: Inclusion Criteria:

* Age 0-17,
* Highly emetogenic chemotherapy with at least 4 similar courses of chemotherapy concerning applied drugs (equivalent dosages)

Exclusion Criteria:

* Age older than 17 years,
* Participation in another clinical trial on supportive care

Primary outcomes:
measure: episodes of retching/vomiting per day during 1 chemotherapy course
timeFrame: 1 chemotherapy course (5 days)
Secondary outcomes:
measure: rescue antiemetic medication during 1 chemotherapy course
timeFrame: 1 chemotherapy course (5 days)
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: University Children's Hospital Tübingen
state: Baden-Wuerttemberg
city: Homburg
country: Germany
facility: University Children's Hospital Homburg
state: Saarland
Study officials:
affiliation: University Children's Hospital Homburg, Germany
name: Sven Gottschling, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Children's Hospital Homburg, Germany
name: Norbert Graf, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04389554: D-dimer Levels in Pregnant With COVID-19
Official title: Assessment of D-dimer Levels in Pregnant Women Diagnosed With COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
D-dimer
Keywords: pregnancy
COVID-19
D-dimer
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2020-05-15
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Kanuni Sultan Suleyman Training and Research Hospital Obstetrics and Gynecology Clinic Patients

Brief summary: D-dimer measurements act as a global indicator of coagulation and activation of fibrinolytic systems. An optimal cut-off value for D-dimer and its effect on prognosis has not yet been assessed to predict mortality in admission. Therefore, studies comparing D-dimer values of COVID-19 patients and healthy pregnant women are needed. Our study gives us the opportunity to make this comparison.


Eligibility criteria: Inclusion Criteria:

* Pregnant women with COVID-19

Exclusion Criteria:

- Having a chronic disease that raises D-dimer levels

Primary outcomes:
measure: Compare D-dimer values of COVID-19 patients and healthy pregnant women
timeFrame: one day
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Kanuni Sultan Suleyman Training and Research Hospital
state: Turgut Ozal
Study officials:
References:
citation: Gutierrez Garcia I, Perez Canadas P, Martinez Uriarte J, Garcia Izquierdo O, Angeles Jodar Perez M, Garcia de Guadiana Romualdo L. D-dimer during pregnancy: establishing trimester-specific reference intervals. Scand J Clin Lab Invest. 2018 Oct;78(6):439-442. doi: 10.1080/00365513.2018.1488177. Epub 2018 Jul 5.
Clinical trial NCT02079454: Post-operative Cardiac Outcome of Non-cardiac Surgery Predicted by INVOS
Official title: Valeur Predictive de l'INVOS Sur l'Outcome Cardiaque en Post-opératoire. (French Title)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Invos
Peri-operative
Cardiac Outcome
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2014-03-05
Enrollment: 34
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: patient with high cardiac comorbidities undergoing a general anesthesia for a surgery of over two hours with bleding potential.

Brief summary: Research aimed to find a correlation with an invos drop and cardiac events in the peri-operative period of non cardiac surgery.

The investigators postulate that a drop in the Invos numbers (with or without significant drop in BP) is associated with a variable degree of cardiac suffering.

The idea is to prevent per and foremostpost-operative myocardial necrosis complications by acting as soon as we have an INVOS drop during anesthesia.

The "cardiac events" will be monitored and defined according to the EHA (european heart association) guidelines.

(Changes of the EKG and/or troponin I values above the threshold). Patient will be monitored per and post operatively.


Eligibility criteria: Inclusion Criteria:

* Male and female
* Age minimum 18 years old

Exclusion Criteria:

* Chronic renal failure

Primary outcomes:
measure: A composite measurement of major vascular events in the post-operative period
timeFrame: 96 hours post-operative
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: cliniques universitaires St Luc
state: Brabant
Study officials:
References: