louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00132912: Safety of SCH 530348 in Subjects Undergoing Non-Emergent Percutaneous Coronary Intervention (Study P03573)
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety of SCH 530348 in Subjects Undergoing Non-Emergent Percutaneous Coronary Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Arterial Obstructive Diseases
Coronary Disease
Keywords: Platelets
Platelet Aggregation Inhibitors
Protease-Activated Receptor 1
Hemorrhage
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2005-08-22
Enrollment: 1030
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The object of the study is to determine whether different doses of SCH 530348, when added to standard medical care in persons undergoing percutaneous coronary intervention, will increase the risk of bleeding.

A secondary objective is to determine whether patients treated with SCH 530348 have fewer cardiac events such as heart attack, bypass surgery, or death compared with those persons treated with the standard of care.


Eligibility criteria: Inclusion Criteria:

* A person who is 45 years or older and is mentally competent to provide a signed written informed consent.
* A person who is scheduled to undergo a percutaneous coronary intervention or a heart catheterization with the intent to undergo a percutaneous coronary intervention.
* If a woman is of childbearing potential (ie, before menopause), she must test negative for pregnancy and agree to use a reliable method of birth control.

Exclusion Criteria:

* Pregnancy
* Recent stroke
* Active internal bleeding or a history of a bleeding disorder
* Increased risk of bleeding
* Severe high blood pressure
* Liver or kidney disease
* Low platelet count
* Condition such as alcoholism, mental illness, or drug dependence
* Ongoing chest pain
* Planned or ongoing treatment with a blood thinning medication
* A serious condition or illness that would interfere with participation in the study

Primary outcomes:
measure: Incidence of bleeding through the end of treatment in subjects undergoing percutaneous coronary intervention
Secondary outcomes:
measure: Incidence of bleeding throughout treatment and follow-up
measure: Incidence of death and major adverse cardiac events
Other outcomes:
Locations:
Study officials:
References:
citation: Becker RC, Moliterno DJ, Jennings LK, Pieper KS, Pei J, Niederman A, Ziada KM, Berman G, Strony J, Joseph D, Mahaffey KW, Van de Werf F, Veltri E, Harrington RA; TRA-PCI Investigators. Safety and tolerability of SCH 530348 in patients undergoing non-urgent percutaneous coronary intervention: a randomised, double-blind, placebo-controlled phase II study. Lancet. 2009 Mar 14;373(9667):919-28. doi: 10.1016/S0140-6736(09)60230-0.
Clinical trial NCT05072912: Screening Study to Identify Patients With Complement Factor I Deficiencies
Official title: Screening Study to Identify Patients With Complement Factor I Deficiencies
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Previous Diagnosis With a Complement-mediated Disease and/or With Clinical Manifestations Reasonably Associated With Complement Factor I Deficiency
Lead sponsor: Catalyst Biosciences
Sponsor class: INDUSTRY
First posted: 2021-10-11
Enrollment: 113
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients previously diagnosed with a complement-mediated disease and/or with clinical manifestations in which a reasonable etiological association with Complement Factor I (CFI) deficiency has been reported.

Examples of these diseases and conditions are (but not limited to): atypical hemolytic uremic syndrome, Complement 3 Glomerulopathy, membranoproliferative glomerulonephritis, systemic lupus erythematosus, leukocytoclastic vasculitis, recurrent bacterial infections, unexplained inflammation or edema, and some autoimmune disorders.

Brief summary: This is screening study to identify patients with Complement Factor I deficiencies. The primary objective is to identify participants with CFI deficiencies and assess the prevalence in the screened population.


Eligibility criteria: Inclusion Criteria:

An individual must meet all the following criteria to be eligible to participate in this study:

1. A male or female ≥6 months of age who has been diagnosed with a complement-mediated disease in which a reasonable etiological association with CFI deficiency has been reported
2. Affirmation of participant's informed consent or LAR's willingness to provide informed consent with signature confirmation before any study-related activities. (Study-related activities are any procedures that would not have been performed during normal clinical management of the participant.) The participant (if a minor) must be willing to give written informed assent if the minor is within the age groups 7 to 11 years old and 12 to 17 years old.

Exclusion Criteria:

1) Diagnosis of age-related macular degeneration that is complement-related with no concurrent systemic complement involvement

Primary outcomes:
measure: Complement Factor I Deficiency Identification
timeFrame: At Screening
Secondary outcomes:
measure: Demographics, Disease Characteristics, Medication Use
timeFrame: At Screening
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Nephrology Consultants, LLC
state: Alabama
Study officials:
References:
Clinical trial NCT01469312: Effect of Pasta on Blood Glucose Response in Normal Subjects
Official title: Effect of Pasta on Blood Glucose Response in Normal Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Glucose Concentration
Type 2 Diabetes
Metabolic Syndrome
Keywords: Low Biologically Available Glucose Diet (LoBAG diet)
Diabetes
Glycemic Index
Lead sponsor: Minneapolis Veterans Affairs Medical Center
Sponsor class: FED
First posted: 2011-11-10
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The objective of this study is to determine whether ingestion of modified pasta products (Dreamfields, Miracle Noodles) result in an improvement in blood glucose concentration when compared with a traditional pasta.

Detailed description: On one occasion the pasta will be a traditionally available pasta; on another occasion, approximately 1 week later a modified pasta, advertised to contain \~ 5 grams of digestible carbohydrate, or to be low in digestible starch, will be studied.

Eligibility criteria: Inclusion Criteria:

* Normal blood glucose concentration

Primary outcomes:
measure: Change in Blood Glucose
timeFrame: 0, 30, 60, 90, 120, and 180 minutes after ingestion
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Minneapolis VA Health Care System
state: Minnesota
Study officials:
affiliation: Minneapolis Veterans Affairs Medical Center
name: Frank Q Nuttall, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Minneapolis Veterans Affairs Medical Center
name: Mary C Gannon, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nuttall FQ, Schweim K, Hoover H, Gannon MC. Effect of the LoBAG30 diet on blood glucose control in people with type 2 diabetes. Br J Nutr. 2008 Mar;99(3):511-9. doi: 10.1017/S0007114507819155. Epub 2007 Sep 10.
Clinical trial NCT05135312: Etanercept Therapy for Nails Psoriasis Monitoring With Noninvasive Imaging
Official title: Monitoring Nail Changes in Patients With Psoriatic Disease Treated With Etanercept Using Non- Invasive Optical Coherence Tomography
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Psoriasis
Psoriatic Arthritis
Psoriatic Nail
Keywords: Psoriasis Nails
Psoriatic Arthritis
Enbrel
Biologic
Lead sponsor: OptiSkin Medical
Sponsor class: OTHER
Collaborators: name: Amgen
First posted: 2021-11-26
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: OptiSkin is now enrolling a new study to monitor nail changes in patients with nail psoriasis treated with Enbrel® (etanercept) with optical coherence tomography (OCT).

Detailed description: Psoriasis often affects the fingernails, making them yellow, brittle, painful and prone to infections. These symptoms can be difficult to manage, so OptiSkin is now enrolling a new study to monitor nail changes in patients with nail psoriasis treated with Enbrel® (etanercept) with optical coherence tomography (OCT).

OCT is being studied as a way to better diagnosis psoriatic nail disease, monitor response to therapy, and identify changes even before they become apparent, potentially leading to earlier treatment or prevention of future psoriatic arthritis.

Study-related care and medication are provided at no cost, and reimbursement for reasonable local transportation may be available to qualified individuals.

Eligibility criteria: Inclusion Criteria:

* Moderate to severe psoriasis
* Psoriasis affecting the fingernails

Exclusion Criteria:

* Previous treatment with Enbrel® (etanercept)
* Active infection
* Rheumatoid arthritis
* Any personal or family history of any neurologic demyelinating disease
* Receipt of investigational drugs or "biologics" within 4 weeks of the screening visit

Primary outcomes:
measure: NAPSI
timeFrame: Baseline to 24 weeks
measure: OCT (clinical)
timeFrame: Baseline to 24 weeks
Secondary outcomes:
measure: OCT (sub-clinical)
timeFrame: Baseline to 24 weeks
measure: Dermoscopy
timeFrame: Baseline to 24 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: OptiSkin Medical
state: New York
Study officials:
affiliation: OptiSkin Medical
name: Orit Markowitz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03893812: Color Doppler and Mri Diffusion in Major Salivary Gland Masses
Official title: Combined Role of Color Doppler and Diffusion Weighted MRI In Differentiation Between Benign and Malignant Tumors of Major Salivary Glands
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Salivary Gland Diseases
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2019-03-28
Enrollment: 50
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: Adult patients with a suspicious swelling in major salivary glands.

Brief summary: This study intend to evaluate the combined value of ADC and COLOR DOPPLER in differentiating benign and malignant salivary gland tumors in comparison to histopathological findings and its use in preoperative prediction of benign and malignant masses.

Detailed description: the study aim to achieve preoperative differentiation between benign and malignant masses of the major salivary glands using the ADC values and Color Doppler values (PSV - PI - RI)

Eligibility criteria: Inclusion Criteria:

1- patients must be 18 of age or older. 2= patients must have a suspicious swelling in major salivary glands.

Exclusion Criteria:

1. Patients with history of metal plates or screws or artificial joints.
2. Patients who have phobia of indoor places.
3. Patients with contraindication to MRI like intra-cerebral aneurysmal clips, cardiac pacemaker, and metallic foreign body at region of examination.

Primary outcomes:
measure: The ADC values and Color Doppler values (PSV-PI-RI) of major salivary gland masses
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03289312: Dissecting How Peripheral Lymphocytes Are Lost During Sepsis
Official title: Dissecting How Peripheral Lymphocytes Are Lost During Sepsis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sepsis
Keywords: sepsis, lymphocyte
Lead sponsor: Southeast University, China
Sponsor class: OTHER
First posted: 2017-09-20
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inclusion Criteria:

* Diagnosis of new onset sepsis within 24h.

Exclusion Criteria:

* History of tumor, hematological or immunological disease, and treatment with chemotherapy agents or corticosteroids within 6 months prior to or during the hospitalization.

Brief summary: There is an observational, clinical study. We recruit sepsis patients to investigate what drives peripheral lymphocyte loss in sepsis.

Detailed description: There is an observational, clinical study. We recruit patients with diagnosis of new onset sepsis within 24h, collect and record clinical characteristics：

①Demography data，diagnosis, admission source, infection source, APACHE II,SOFA scores;②Endotoxin levels and PaO2 measured;③Immune and systemic inflammatory indicators：T, RR, WBC, ALC, etc.;④Complicated organs dysfunctions: duration and therapy;⑤Incidence of ICU-acquired infection and prognosis.The blood samples were collected for apoptosis,necrosis,autophagy,pyroptosis measurements.The aim of this study is to investigate how peripheal lymphocyte loss relates to outcome and the mechanisms of peripheal lymphocyte loss in different condition.

Eligibility criteria: Inclusion Criteria:

* Health volunteers

Exclusion Criteria:

* History of tumor, hematological or immunological disease, and treatment with chemotherapy agents or corticosteroids within 6 months prior to or during the hospitalization.

Primary outcomes:
measure: lymphocyte loss
timeFrame: day of inclussion and 7th day after inclussion
Secondary outcomes:
measure: prognosis
timeFrame: 28-day after inclussion
measure: Complicated organ dysfunction
timeFrame: during 28 days after inclussion
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Zhongda Hospital
state: Jiangsu
Study officials:
References:
Clinical trial NCT01239212: Dosing of Levetiracetam (Keppra) in Neonates
Official title: Pharmacokinetics and Safety of 50 mg/kg IV Levetiracetam (Keppra) in Full Term and Preterm Neonates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Seizures
Keywords: seizures
neonate
levetiracetam
Epilepsy
central nervous system diseases
anticonvulsants
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2010-11-11
Enrollment: 7
Sex: ALL
Minimum age (years): 1
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to determine the pharmacokinetic profile of a 50 mg/kg loading dose of intravenous levetiracetam (LEV) in term and late preterm infants with seizures. Secondary objectives are to evaluate the safety and efficacy of a 50 mg/kg loading dose of levetiracetam in term and preterm infants with seizures, and to obtain data on steady state drug levels of levetiracetam in neonates.


Eligibility criteria: Inclusion Criteria:

* Gestational age ≥ 32 weeks
* Postnatal age ≤ 30 days
* Birth weight ≥ 2000 grams
* Admitted to the Neonatal Intensive Care Unit at Cincinnati Children's Hospital
* Clinical or electrographic seizures of any etiology
* Seizures or seizure prophylaxis requiring treatment with levetiracetam
* Parental consent obtained

Exclusion Criteria:

* Infants with renal insufficiency indicated by serum creatinine \> 2.0 at any time
* Infants who have previously received levetiracetam
* Parents refuse consent
* Attending physician does not wish the infant to be enrolled in the study
* Infants who are currently receiving an investigational drug

Primary outcomes:
measure: Pharmacokinetic Profile
timeFrame: 5-20 minutes after the dose, 1-2 hours after the dose, 6-10 hours after the dose, and possibly 4-7 days after loading dose (if infants remained on maintenance doses)
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Stephanie Merhar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03154112: Validation of a Novel Oxygen Consumption Measurement Technique in Neonates
Official title: Validation of a Novel Oxygen Consumption Measurement Technique in Neonates
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neonatal Respiratory Failure
Congenital Heart Defect
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: Innovision
First posted: 2017-05-16
Enrollment: 14
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be selected from inpatients in the neonatal or cardiac intensive care unit who are mechanically ventilated.

Brief summary: The measurement of how much oxygen a baby consumes provides important information about the health of the baby, and of how much energy they are consuming. Currently, there is no device which measures either oxygen consumption, or another variable that depends on oxygen consumption - resting energy expenditure - in neonates or infants. Our group has developed a new device which can attach to any ventilator and measures these two variables with accuracy in the preclinical setting, including in rodents as small as severely preterm infants. The purpose of this study is to compare measurements of oxygen consumption and energy expenditure in neonates using this device and comparing it with a gold standard which is rarely used, a Douglas bag method in which expired gas is collected and later analyzed.


Eligibility criteria: Inclusion criteria.

1. Mechanically ventilated neonates and infants (\<1 year of age).
2. Inpatients in the cardiac or neonatal intensive care unit at Boston Children's Hospital.
3. Assent of patient's intensive care attending physician, including agreement to place patient on 40% oxygen for up to 60 minutes.
4. Written parental informed consent.

Exclusion criteria.

1. Hemodynamic or respiratory instability.
2. Patients on extracorporeal membrane oxygenation support.
3. Clinically significant tracheo-esophageal fistula
4. Measured endotracheal tube leak \>20% (i.e. difference between inspiratory and expiratory tidal volumes)

Primary outcomes:
measure: Oxygen consumption
timeFrame: 1 hour
measure: Carbon dioxide production
timeFrame: 1 hour
measure: Respiratory quotient
timeFrame: 1 hour
measure: Resting energy expenditure
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
References:
citation: Nachman E, Clemensen P, Santos K, Cole AR, Polizzotti BD, Hofmann G, Leeman KT, van den Bosch SJ, Kheir JN. A Device for the Quantification of Oxygen Consumption and Caloric Expenditure in the Neonatal Range. Anesth Analg. 2018 Jul;127(1):95-104. doi: 10.1213/ANE.0000000000003308.
Clinical trial NCT01668212: Perifollicular Doppler in Natural Cycle In Vitro Fertilization
Official title: Perifollicular Doppler in Natural Cycle In Vitro Fertilization
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Lead sponsor: Clinique Ovo
Sponsor class: INDUSTRY
First posted: 2012-08-20
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women following In Vitro Fertilization cycle

Brief summary: Perifollicular Doppler could reflect the quality of the follicle's vascularization and, consequently, the one of the oocyte that ensues from it. Perifollicuar Doppler is the analysis, in ultrasound, of the blood flow in vessels surrounding the follicle.

The goal of this study is to evaluate if there is a link, in natural cycle In Vitro Fertilization, between the quality of the vascularization and the one of the oocyte, the embryo and the pregnancy.


Eligibility criteria: Inclusion Criteria:

* Patient with a natural In Vitro Fertilization cycle.
* Patient under 38 years old
* Body mass indice under 35
* Ovulatory cycles between 20-35 days

Exclusion Criteria:

* Patient with a stimulation In Vitro Fertilization cycle
* Patient with a naturalIn Vitro Fertilization cycle with egg donor
* Patient with a natural In Vitro Fertilization cycle with freezing embryo
* Smoking patient
* Diabetic patient
* Patient with treatment of antihypertensive drug, anticoagulant, antiplatelet, vasodilator
* Body mass indice over 35
* Patient over 38 years old
* Patient without ovulation or cycle over 35 days
* Percutaneous Epididymal Sperm Aspiration (PESA), Testicular Sperm Extraction (TESE) or micro TESE

Primary outcomes:
measure: Quality perifollicular doppler and quality of the oocyte
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Ovo Fertilité
state: Quebec
Study officials:
affiliation: Clinique Ovo
name: Delphine Delrieu, MD
role: PRINCIPAL_INVESTIGATOR
References: