louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00482287: Pharmacokinetics and Pharmacodynamics of MTR105 in Hypotensive Cardiac Surgery Patients
Official title: A Phase II, Randomized, Double Blind, Placebo-controlled, Dose-escalating Study to Assess the Pharmacokinetics and Pharmacodynamics of MTR105 in Cardiac Surgery Induced Hypotension Patients During Weaning Off Cardiopulmonary Bypass
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Hypotension
Cardiopulmonary Bypass
Lead sponsor: Meditor Pharmaceuticals Ltd.
Sponsor class: INDUSTRY
First posted: 2007-06-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety, pharmacokinetic and the pharmacodynamic effects of escalating doses of MTR105 while weaning from bypass in a hypotensive population of cardiac surgery patients.

Detailed description: The study is a prospective, randomized, four-arm, dose-escalating, double blind, placebo controlled study evaluating the safety, pharmacokinetics, and pharmacodynamics of four dose levels of MTR105 in patients undergoing cardiac surgery utilizing cardiopulmonary bypass presenting hypotension upon weaning off bypass.

Eligibility criteria: Inclusion Criteria:

* Men or women age 18 years or older
* Referred for cardiac surgery requiring the use of CPB.
* Elective or urgent surgeries (non emergency operations).
* LVEF ≥40 based on cardiac catheterization results
* Normal renal function at study entry
* Normal hepatic function (within normal laboratory ranges) at study entry
* Normal coagulation status at study entry as judged by PT, PTT, fibrinogen and platelet count.
* Willingness to participate in the study and adhere to the study design.
* Willingness to sign an informed consent form.

Exclusion Criteria:

* Emergency operation
* Pulmonary hypertension (PA systolic pressure \>60 mmHg)
* Ejection fraction less than 35% during weaning from bypass or cardiac index of less than 1.8
* Neurological events such as prior CVA, TIA or symptomatic carotid stenosis within 1 year of presenting for surgery
* Body weight \<40 Kg
* Pregnancy
* Malignancy within 1 year of presenting for surgery
* Systemic infection as evidenced by elevated WBC or fever \>38.5 C
* Usage of vasoactive medications within 24 hours except short term use of a vasoconstrictor during induction.
* Participation in any other investigational drug or device study within 30 days of randomization

Primary outcomes:
measure: Hemodynamic parameters
timeFrame: 24 hours
Secondary outcomes:
measure: Pharmacokinetics
timeFrame: 10 hours
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh Medical Center
name: Penny Sappington, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03405987: Association of T1-mapping and LV Strain Analysis by CMR
Official title: Association of T1-mapping and LV Strain Analysis by CMR
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Myocardial Fibrosis
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2018-01-23
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: PROBABILITY_SAMPLE
Study population: Patients undergoing CMR for whatever reason will be invited to participate. A specific subgroup of patients are heart failure with preserved ejection fraction.

Brief summary: The association of T1-mapping (both native and ECV) and strain analysis of LV and RV by CMR will be assessed. Results from strain analysis will be investigated in terms of their prognostic value.


Eligibility criteria: Inclusion Criteria:

* undergoing CMR
* willingness to participate

Exclusion Criteria:

* \<18 years old
* pregnancy

Primary outcomes:
measure: Association of native LV T1-values and strain analysis
timeFrame: Baseline
measure: Association of ECV and strain analysis
timeFrame: Baseline
measure: Association of strain analysis and outcome
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
References:
Clinical trial NCT01224587: Magnetic Marker Monitoring (MMM) Study With Gel Matrix Tablets Under Fasting and Fed Conditions
Official title: Characterisation of Gastrointestinal Transit of Four New Developed Gel Matrix Tablets With Different Erosion Rates by Means of MMM Measurement Under Fasting and Fed Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Magnetic Marker Monitoring
Gastrointestinal-transport
Gastric Emptying Time
Small Intestinal Transit Time
Time for Colon Arrival
Food Effect
Keywords: Imaging technique
gastric transport through the gut
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-10-20
Enrollment: 5
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to monitor the gastrointestinal transport of eroding gel matrix placebo tablets in healthy male volunteers under fasting and fed conditions. The method which is used is an imaging technique.


Eligibility criteria: Inclusion Criteria:

* Ethnic origin: Caucasian
* Body-mass index (BMI): ≥ 19 kg/m² and ≤ 27 kg/m²
* Good health
* Written informed consent, after having been informed about benefits and potential risks of the trial

Exclusion Criteria:

* Diseases which could influence the gastric emptying and gastrointestinal transport
* Diet which could influence the gastric emptying and gastrointestinal transport
* Surgery in the gastrointestinal tract which may interfere with the safety and transport of test product
* Ferromagnetic implants or any other magnetic disturbance, which can affect the Magnetic Marker Monitoring measurement
* Regular medical treatments which could affect the gastric emptying and gastrointestinal transport

Primary outcomes:
measure: The time from an administration of each of the placebo gel matrix tablets of each arm until Gastric Emptying Time (GET)
measure: The time from an administration of each of the placebo gel matrix tablets of each arm until Colon Arrival Time (CAT)
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Research Site
Study officials:
affiliation: Socra Tec R&D GmbH, Clinical Pharmacology Unit
name: Frank Donath, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Socra Tec R&D GmbH
name: Maria Anschütz
role: STUDY_CHAIR
References:
Clinical trial NCT00613587: Roflumilast In-Vitro Basophil Release
Official title: Effect of Roflumilast In-Vitro on Basophil Histamine, Leukotriene, IL-4 and IL13-release.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Allergy
Asthma
Keywords: Interleukin 13
Interleukin 4
Leukotrienes
Basophil Histamine Release
Lead sponsor: Creighton University
Sponsor class: OTHER
Collaborators: name: Takeda
First posted: 2008-02-13
Enrollment: 15
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Allergic Asthma, non-smoker

Brief summary: This study is looking for allergic asthmatics. Lung and allergy testing will be done to verify. If qualified, blood will be drawn for laboratory studies.

Detailed description: Non-smoking allergic asthmatics will be verified using pulmonary function, skin prick testing, exhaled nitric oxide and serum IgE. If qualified, blood will be drawn, treated with study medication and then stimulated with the allergen to which the subject is allergic. Mediators including Histamine, IL-13, IL-4, and leukotrienes will be measured.

Eligibility criteria: Inclusion Criteria:

* Age 19 and above Allergic Asthma Serum IgE greater than 30iu/ml Exhaled Nitric Oxide greater than 17ppb

Exclusion Criteria:

* smoking history

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Creighton University Medical Center
state: Nebraska
Study officials:
affiliation: Creighton University
name: Robert G Townley, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01598259: Randomized Controlled Trial to Assess Efficacy of Melatonin for Children During Burn Rehabilitation
Official title: Randomized Controlled Trial to Assess Efficacy of Melatonin for Children During Burn Rehabilitation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Burns
Lead sponsor: Shriners Hospitals for Children
Sponsor class: OTHER
First posted: 2012-05-15
Enrollment: 10
Sex: ALL
Minimum age (years): 5
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The specific aims of this investigation in children during burn rehabilitation include 1.) to determine the efficacy of melatonin intervention on improving sleep-related outcomes 2.) investigate the hypothesis that sleep inadequacy is associated with cognitive deficits and 3.) develop a new methodology specific for burn patients that accurately screens for the presence of intrinsic dyssomnia.


Eligibility criteria: Inclusion Criteria:

* History of burn injury
* Scheduled for an elective surgical procedure
* 5 - 22 years of age, inclusive

Exclusion Criteria:

* History of anoxic brain injury
* History of head injury within the last year
* Pre-existing seizure disorder
* Pre-existing neurological disorder
* Pre-existing blindness
* Known hypersensitivity to melatonin
* Anticoagulant use or aspirin therapy
* Antihypertensive medication use
* Diabetes mellitus or other endocrine disorders
* Autoimmune disorders
* Schizophrenia
* Inability to access internet
* Intellectual disability or inability to follow directions

Primary outcomes:
measure: sleep
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Shriners Hospital for Children
state: Ohio
Study officials:
References:
Clinical trial NCT01764659: 4D-CT for Pancreatic Adenocarcinoma in Radiotherapy Simulation
Official title: Individually Optimized Contrast-Enhancement 4D-CT for Pancreatic Adenocarcinoma in Radiotherapy Simulation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Adenocarcinoma
Keywords: 4D-CT
Contrast Enhanced CT
Radiotherapy Simulation
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2013-01-09
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: GI/GU multi-d clinic

Brief summary: The primary objective is to study the feasibility and efficacy of individually optimized CE 4D-CT for PDA in radiotherapy simulation.

Detailed description: Compared with current clinical practice, the individually optimized CE 4D-CT can potentially provide much improved tumor-to-parenchyma conspicuity of pancreatic adenocarcinoma. This will help the radiation oncologists or radiologists to contour the tumor with higher precision and confidence, and compute the tumor volume and tumor motion more accurately.

Eligibility criteria: Inclusion Criteria:

1. Patients 18 years old or older
2. Patients with PDA who have not had surgical removal of their tumor and who are planned for treatment with radiotherapy in the Radiation Oncology Department at the University of Maryland.
3. Patients who have signed the contrast consent form and have been recommended by physicians to have contrast-enhanced CT scans.
4. Patients who have signed the consent form for this study

Exclusion Criteria:

1. Pregnant or breast-feeding women.
2. Patients with severely decreased renal function19-21.
3. Patients with known severe allergic reactions to contrast.
4. Patients who have difficulty lying flat on their back for extended periods of time.
5. Patients with breaths per minute (BPM) rate less than 10, due to the limitation of 4D-CT image reconstruction software.

Primary outcomes:
measure: Individually Optimized Contrast-enhanced 4DCT for Radiotherapy Simulation
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Ummc Msgcc
state: Maryland
Study officials:
affiliation: UMMC MSGCC
name: Wei Lu, Ph. D., DABR
role: PRINCIPAL_INVESTIGATOR
affiliation: UMMC
name: Hao H Zhang, Ph. D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05763459: A Phase 1 Study of ABBV-CLS-7262, Rosuvastatin, and Digoxin in Healthy Subjects
Official title: A Phase 1 Study to Evaluate the Drug-Drug Interaction Between ABBV-CLS-7262, Rosuvastatin, and Digoxin Following Multiple Doses of ABBV-CLS-7262
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Digoxin
Rosuvastatin
Molecular Mechanisms of Pharmacological Action
Physiological effects of drugs
Lead sponsor: Calico Life Sciences LLC
Sponsor class: INDUSTRY
Collaborators: name: AbbVie
First posted: 2023-03-10
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study follows an open-label, single arm design with two periods with rosuvastatin, digoxin and ABBV-CLS-7262

Detailed description: Period 1: One single dose of rosuvastatin and one single dose of digoxin on Day 1.

Period 2: Multiple doses of ABBV-CLS-7262 once daily from Day 1 to Day 8. On Day 5, one single dose of rosuvastatin and one single dose of digoxin with the dose of ABBV-CLS-7262 on that day.

Eligibility criteria: Inclusion Criteria:

* Adult volunteers in general good health
* Must voluntarily sign and date an informed consent, approved by an independent ethics committee (IEC)/institutional review board (IRB), prior to the initiation of any screening or study-specific procedures
* Individuals between 18 and 65 years of age inclusive at the time of screening
* BMI is ≥ 18.0 to ≤ 32.0 kg/m2
* All male subjects who are sexually active and not surgically sterilized must agree to use an acceptable contraceptive method. Additionally, male subjects must agree to not donate sperm during the study until 30 days after the final dose of study drug
* All female subjects who are sexually active and of childbearing potential must agree to use a highly effective contraceptive method. Additionally, female subjects must agree to not donate eggs during the study and for 30 days after the final dose of study drug.

Exclusion Criteria:

* Subject who, in the opinion of the investigator, is incapable of completing study-required visits and procedures
* Pregnant or breastfeeding.
* Treatment with any other investigational treatment within 30 days

Primary outcomes:
measure: Pharmacokinetics of Rosuvastatin
timeFrame: Two Weeks
measure: Pharmacokinetics of Digoxin
timeFrame: Two Weeks
Secondary outcomes:
measure: Safety and Tolerability
timeFrame: Two Weeks
Other outcomes:
Locations:
city: Grayslake
country: United States
facility: AbbVie Clinical Pharmacology Research Unit (ACPRU)
state: Illinois
Study officials:
References:
Clinical trial NCT01394159: 22G FNA Needle vs. 22G ProCore Needle
Official title: Randomized Trial Comparing the 22-gauge Aspiration and 22-gauge Biopsy Needles for EUS-guided Sampling of Solid Pancreatic Mass Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Neoplasm
Keywords: passes required to establish diagnosis
Lead sponsor: AdventHealth
Sponsor class: OTHER
First posted: 2011-07-14
Enrollment: 56
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this research study is to identify the best needle for performing biopsy during EUS procedures. There are two types of needles for performing biopsy: A FNA needle that provides a small sample of tissue for analysis and a 22G ProCore needle that provides larger amount of tissue. It is not clear at this point which of the two needles is superior for performing biopsy. This study will attempt to identify the better needle by assessing the performance of both needles in a randomized fashion.

Detailed description: In this randomized trial, the 22G standard fine needle aspiration needle was compared with the newly developed 22G ProCore needle for sampling pancreatic mass lesions during endoscopic ultrasound. Patients were randomized into the two needle groups and then various outcomes were compared between the two needle types, including the number of passes needed to establish a diagnosis, the ability to procure enough tissue sample to be able to make a diagnosis, the rates of needle failure and complication rates.

Eligibility criteria: Inclusion Criteria:

-All patients with solid pancreatic mass lesions

Exclusion Criteria:

* Coaguloapthy,
* minors,
* prgenant patients

Primary outcomes:
measure: Compare the Median Number of Passes Required to Establish a Diagnosis
timeFrame: 6 months
Secondary outcomes:
measure: Diagnosis Achieved With the Needle
timeFrame: 6 months
measure: Technical Failure
timeFrame: 6 months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Shyam Varadarajulu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bang JY, Hebert-Magee S, Trevino J, Ramesh J, Varadarajulu S. Randomized trial comparing the 22-gauge aspiration and 22-gauge biopsy needles for EUS-guided sampling of solid pancreatic mass lesions. Gastrointest Endosc. 2012 Aug;76(2):321-7. doi: 10.1016/j.gie.2012.03.1392. Epub 2012 May 31.
Clinical trial NCT00213759: Prevention Trial of Nosocomial Infections in Neutropenic Prematures With G-CSF
Official title: Prevention Trial of Nosocomial Infections in Neutropenic Prematures With G-CSF
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Neutropenia in Prematures
Keywords: neutropenia
prematurity
nosocomial infection
G-CSF
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2005-09-21
Enrollment: 200
Sex: ALL
Minimum age (years): 2
Maximum age (years): 35
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Prevention trial of nosocomial infections in neutropenic prematures with G-CSF


Eligibility criteria: Inclusion Criteria:

\< 33 weeks GA neutropenic during at least 24 hours in the first 3 weeks of life and not infected at time of inclusion \< 35 if birth weight \< 1500 g

Primary outcomes:
measure: survival without infection at 4 weeks after treatment
timeFrame: one month
Secondary outcomes:
measure: survival free of infection at 2 weeks after treatment,mortality, increase of neutrophile, number of septic event, incidence of chronic lung disease, necrotizing enterocolitis, cerebral us abnormalities, retinopathy , duration of hospitalisation stay
timeFrame: one month
Other outcomes:
Locations:
city: Bayonne
country: France
facility: Xavier Hernandorena
city: Besancon
country: France
facility: Alain Menget
city: Bordeaux
country: France
facility: Jean-Louis Demarquez
city: Caen
country: France
facility: Bernard Guillois
city: Calais
country: France
facility: Marie Thieuleux
city: Clermont-Ferrand
country: France
facility: André Labbe
city: Dijon
country: France
facility: Jean-Bernard Gouyon
city: Grenoble
country: France
facility: Pierre Andrini
city: Strasbourg
country: France
facility: Jean Messer
Study officials:
affiliation: Hopitaux Universitaires de Strasbourg
name: Jean Messer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kuhn P, Messer J, Paupe A, Espagne S, Kacet N, Mouchnino G, Klosowski S, Krim G, Lescure S, Le Bouedec S, Meyer P, Astruc D. A multicenter, randomized, placebo-controlled trial of prophylactic recombinant granulocyte-colony stimulating factor in preterm neonates with neutropenia. J Pediatr. 2009 Sep;155(3):324-30.e1. doi: 10.1016/j.jpeds.2009.03.019. Epub 2009 May 24.
Clinical trial NCT00002059: A Double-Blind Placebo Controlled Study To Determine the Optimal Immunopharmacological Dose Level of Isoprinosine in Immunodepressed Volunteers
Official title: A Double-Blind Placebo Controlled Study To Determine the Optimal Immunopharmacological Dose Level of Isoprinosine in Immunodepressed Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Keywords: T-Lymphocytes, Suppressor-Effector
Neoplasms
Inosine Pranobex
Killer Cells
T-Lymphocytes, Helper-Inducer
Acquired Immunodeficiency Syndrome
AIDS-Related Complex
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The objective of this double-blind placebo-controlled study is to evaluate the effect of Isoprinosine in a group of homogenous male volunteers who present with immunologic defects relative to:

* Comparison of total helper and suppressor T-cell number between the groups.
* Comparison of the phytohemagglutinins (PHA) and concanavalin A lymphoproliferative response and natural killer (NK) cell activity between the groups.
* Determination of the clinical course of the volunteers after discontinuance of Isoprinosine.


Eligibility criteria: Exclusion Criteria

Co-existing Condition:

Patients with the following are excluded:

* Opportunistic infections or Kaposi's sarcoma.
* Critical illness.
* History of gout, urolithiasis, nephrolithiasis, renal dysfunction, and severe gastric ulcer.

Concurrent Medication:

Excluded:

* Steroids.
* Cytotoxic immunosuppressive agents.

Concurrent Treatment:

Excluded:

* Radiotherapy.

The following are excluded:

* Opportunistic infections or Kaposi's sarcoma.
* Critically ill patients.
* Patients receiving steroids, cytotoxic immunosuppressive agents, and/or radiotherapy.
* Patients who have received any other immunotherapy.
* Patients with a history of gout, urolithiasis, nephrolithiasis, renal dysfunction, and severe gastric ulcer.

Prior Medication:

Excluded:

* Any other immunotherapy.

Patients who fall into the group which is at risk of developing cutaneous sarcoma and/or opportunistic diseases but at present have no signs or symptoms of these diseases.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Laguna Hills
country: United States
facility: Newport Pharmaceuticals International Inc
state: California
Study officials:
References: