louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00696904: Study of ABT-333 in Both Healthy Volunteers and Hepatitis C Virus (HCV) + Genotype 1 Infected Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HCV Infection
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2008-06-13
Enrollment: 133
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to assess the safety, tolerability, pharmacokinetics of ABT-333 in healthy volunteers and the antiviral activity in HCV infected subjects.

Detailed description: Phase 1, double-blind, randomized, placebo-controlled clinical trial in healthy and HCV genotype 1 infected adults to evaluate safety, tolerability, antiviral activity and pharmacokinetics of ABT-333.

Eligibility criteria: Inclusion Criteria:

* Main Selection Criteria for Healthy Volunteers:

  * Subject has provided written consent.
  * Subject is in general good health.
  * If female, subject is postmenopausal.
  * If female, subject is not pregnant and is not breast-feeding.
* Main Selection Criteria for HCV+ Subjects:

  * Subject is HAV-IgM, HBsAg or HIV Ab negative.
  * Subject is HCV genotype 1 with HCV RNA of \> 50,000 IU/mL.
  * Subject is excluded if they have previously received antiviral therapy for HCV infection
  * Subjects must demonstrate chronic hepatitis C infection for at least 6 months prior to study enrollment
  * Subjects must have a prior liver biopsy with histology consistent with HCV induced liver damage, and with no evidence of cirrhosis or liver pathology due to any cause other than chronic HCV.

Exclusion Criteria:

See above for main selection criteria

Primary outcomes:
measure: Analysis of pharmacokinetic variables and mean change in HCV RNA level from baseline.
timeFrame: approximately 1 week or less
measure: Analysis of safety measures, including but not limited to tabulation of adverse events, physical exam, clinical lab results (include chemistry, hematology and urine) and vital signs.
timeFrame: approximately 1 week
Secondary outcomes:
measure: Analysis of variance of pharmacokinetic variables for subjects fasting or nonfasting.
timeFrame: approximately 1 week
Other outcomes:
Locations:
Study officials:
References:
citation: Mensing S, Polepally AR, Konig D, Khatri A, Liu W, Podsadecki TJ, Awni WM, Menon RM, Dutta S. Population Pharmacokinetics of Paritaprevir, Ombitasvir, Dasabuvir, Ritonavir, and Ribavirin in Patients with Hepatitis C Virus Genotype 1 Infection: Combined Analysis from 9 Phase 1b/2 Studies. AAPS J. 2016 Jan;18(1):270-80. doi: 10.1208/s12248-015-9846-1. Epub 2015 Nov 23.
Clinical trial NCT00251004: Efficacy and Safety Study of Everolimus Plus Reduced Cyclosporine Versus Mycophenolic Acid Plus Cyclosporine in Kidney Transplant Recipients
Official title: Efficacy and Safety Study Comparing Concentration-controlled Everolimus in Two Doses (1.5 and 3.0 mg/Day Starting Doses) With Reduced Cyclosporine Versus 1.44 g Mycophenolic Acid (as Sodium Salt) With Standard Dose Cyclosporine in de Novo Renal Transplant Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Kidney Transplantation
Graft Rejection
Keywords: Renal transplantation, kidney, and organ transplant
Renal transplant rejection
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-11-09
Enrollment: 833
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to compare the safety and efficacy of three immunosuppressive treatment regimens following a kidney transplant.


Eligibility criteria: Inclusion Criteria:

* Male and female patients of any race between 18 to 70 years old (inclusive)
* Patients who gave written informed consent to participate in the study

Exclusion Criteria:

* Recipients of multi-organ transplantation
* Recipients of a primary cadaveric or primary non-human leucocyte antigen (HLA) identical living donor kidney transplantation.
* Graft cold ischemia time greater than 40 hours.

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Number of Participants With Composite Efficacy Endpoints - 12 Month Analysis
timeFrame: 12 months
measure: Non-inferiority Analysis on Percentage of Participants With Composite Efficacy Endpoints
timeFrame: 12 months
Secondary outcomes:
measure: Percentage of Participants With the Composite Incidence of Graft Loss, Death or Loss to Follow up at 12 Months Post-transplantation
timeFrame: 12 months
measure: Non-inferiority Analysis of Renal Function, Calculated by Glomerular Filtration Rate (cGFR) Using Modification of Diet in Renal Disease (MDRD) Formula
timeFrame: at 12 months
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis
state: New Jersey
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_DIRECTOR
References:
citation: Cibrik D, Silva HT Jr, Vathsala A, Lackova E, Cornu-Artis C, Walker RG, Wang Z, Zibari GB, Shihab F, Kim YS. Randomized trial of everolimus-facilitated calcineurin inhibitor minimization over 24 months in renal transplantation. Transplantation. 2013 Apr 15;95(7):933-42. doi: 10.1097/TP.0b013e3182848e03.
citation: Shihab FS, Cibrik D, Chan L, Kim YS, Carmellini M, Walker R, Zibari G, Pattison J, Cornu-Artis C, Wang Z, Tedesco-Silva H Jr. Association of clinical events with everolimus exposure in kidney transplant patients receiving reduced cyclosporine. Clin Transplant. 2013 Mar-Apr;27(2):217-26. doi: 10.1111/ctr.12045. Epub 2012 Dec 12.
Clinical trial NCT05189704: The Effect of PCA on PONV After Microvascular Decompression
Official title: The Effect of Patient-controlled Analgesia (Ketorolac vs. Fentanyl) on the Development of Postoperative Nausea and Vomiting in Patients Undergoing Microvascular Decompression: a Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Postoperative Nausea and Vomiting
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2022-01-12
Enrollment: 94
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study is a randomized, controlled, double-blinded, and parallel design study. A total 94 patients will be randomized to receive ketorolac or fentanyl based patient-controlled analgesia after microvascular decompression surgery.


Eligibility criteria: Inclusion Criteria:

* Patients who undergo elective microvascular decompression surgery
* American Society of Anesthesiologists grade 1 or 2
* 19 - 65 years old

Exclusion Criteria:

* Refuse to participate to the study
* Refuse to use Patient-controlled analgesia
* Body Mass Index \< 18.5 kg/m2 or \> 35 kg/m2
* history of craniotomy or chemotheraphy
* Patients who used preoperative antiemetics within 24h before surgery
* Severe renal or hepatic dysfunction
* Pregnant

Primary outcomes:
measure: Postoperative nausea and vomiting
timeFrame: postoperative 48 hours
Secondary outcomes:
measure: Postoperative nausea and vomiting
timeFrame: Postoperative 30 minutes, 1 hours, 24 hours, 48 hours
measure: Postoperative pain
timeFrame: Postoperative 30 minutes, 1 hours, 24 hours, 48 hours
measure: Postoperative PCA consumption
timeFrame: Postoperative 30 minutes, 1 hours, 24 hours, 48 hours
measure: Rescue antiemetics requirement
timeFrame: Postoperative 30 minutes, 1 hours, 24 hours, 48 hours
measure: Rescue analgesic requirement
timeFrame: Postoperative 30 minutes, 1 hours, 24 hours, 48 hours
measure: Satisfaction score for postoperative nausea and vomiting
timeFrame: postoperative 48 hours
measure: Satisfaction score for postoperative pain
timeFrame: postoperative 48 hours
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Chang-Hoon Koo
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06181604: Multicenter Symphony IL-6 Monitoring Sepsis ICU Study
Official title: Multicenter Symphony IL-6 Monitoring Sepsis ICU Pilot Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Sepsis
Septic Shock
Keywords: Interleukin-6
IL-6
Risk Stratification
Infections
Toxemia
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Sepsis
Septic Shock
Shock
Lead sponsor: Bluejay Diagnostics, Inc.
Sponsor class: INDUSTRY
First posted: 2023-12-26
Enrollment: 143
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients diagnosed with sepsis or septic shock, in accordance with the Sepsis-3 criteria, admitted or intended to be admitted to the ICU.

Brief summary: The primary objective of this study is to establish an IL-6 concentration cutoff and optimal time point(s) for using Symphony IL-6 that predict 28-day mortality in patients who are admitted or are intended to be admitted to the intensive care unit (ICU) diagnosed with sepsis or septic shock.


Eligibility criteria: Inclusion Criteria:

* Adult patients (≥22 years of age)
* Diagnosis of sepsis or septic shock based on: the Third International Consensus Definitions (Sepsis-3 criteria) defined as at least one of the following criteria as determined by a treating physician or study physician investigator.
* Admitted or intended to be admitted to the ICU
* At least 0.4ml plasma drawn and available for collection (or is anticipated to be able to be drawn and available) within 12 hours of the earliest diagnosis of sepsis or septic shock.

Exclusion Criteria:

* Prisoners or imprisonment at time of enrollment
* Prior enrollment into this study
* Informed consent as approved by IRB is unable to be obtained.

Primary outcomes:
measure: 28-day all-cause mortality
timeFrame: Within 28 days after inclusion
Secondary outcomes:
measure: In-hospital mortality up to 28 days
timeFrame: Within 28 days after inclusion
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Saint Louis
country: United States
facility: Washington University of St. Louis
state: Missouri
city: Brooklyn
country: United States
facility: NewYork-Presbyterian Brooklyn Methodist Hospital
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest School of Medicine
state: North Carolina
city: Columbus
country: United States
facility: The Ohio State University/Wexner Medical Center
state: Ohio
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Salt Lake City
country: United States
facility: Intermountain Healthcare
state: Utah
Study officials:
References:
Clinical trial NCT06961604: A Novel Method for Determination of Thromboembolic Stroke Origin
Official title: A Novel Method for Determination of Thromboembolic Stroke Origin
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Thromboembolic Stroke
Lead sponsor: Atlantic Health System
Sponsor class: OTHER
First posted: 2025-05-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Rupture of vulnerable carotid, vertebral, and intracranial arterial plaques results in thromboembolic stroke. Identification of these culprit lesions is an important component of post-stroke care. This study seeks to test the feasibility of NaF PET-CT to detect these plaques and alter patient care. Prior studies have shown a high degree of correlation between NaF PET+ lesions and high-risk plaque features on high resolution MRI, including mirocalcification, necrosis, and ulceration.


Eligibility criteria: Inclusion Criteria: 18 years of age or older with a non-cardiogenic thromboembolic stroke in the past 14 days.

Exclusion Criteria: Less than 18 years of age, any other kind of stroke, not clinically stable to undergo PET-CT

Primary outcomes:
measure: Culprit lesion
timeFrame: Within 14 days of the stroke
Secondary outcomes:
measure: Recurrent stroke
timeFrame: Within 1 year of imaging
measure: Management change
timeFrame: Within 1 year of imaging
Other outcomes:
Locations:
city: Summit
country: United States
facility: Overlook Medical Center
state: New Jersey
Study officials:
References:
Clinical trial NCT02336204: Alcohol Consumption Relation With Nutritional Knowledge and Body Weight
Official title: Effect of Alcohol Consumption and Nutritional Knowledge on Body Weight and Composition in a Group of Piacenza Students
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Binge Drinking
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
First posted: 2015-01-12
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 19
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 104 healthy subjects (56 males and 54 females)

Brief summary: The increase of overweight and obesity in young Italian people, nowadays showed by several epidemiological data, has been related to the misuse of alcohol and to a lack in nutritional knowledge.

Thus the aim of our study was to investigate if different nutritional knowledge from could affect body composition and drinking habits of a cohort of local young people.

104 healthy subjects (56 males and 54 females) were recruited using oral advertisements among the students of 18-19 years-old belonging to the Istituto Agrario and the Istituto alberghiero Raineri-Marcora of Piacenza. The subjects were asked to complete a questionnaire on alcohol consumption and another one related to nutritional knowledge. Then anthropometric data were measured: height, weight, waist and hips circumferences, waist-hips ratio and skinfolds were evaluated for each subject and body fat mass was calculated.


Eligibility criteria: Inclusion Criteria:

* students

Exclusion Criteria:

* pregnant or breast feeding
* vegan or vegetarian

Primary outcomes:
measure: anthropometric measures
timeFrame: 1day
measure: questionnaires on nutritional knowledge
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00006504: Flavonoids and Cardiovascular Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Heart Diseases
Cerebrovascular Accident
Myocardial Infarction
Coronary Disease
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2000-11-17
Sex: ALL
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To determine the association between flavonoids intake and the prevention of incident cardiovascular disease (CVD).

Detailed description: BACKGROUND:

Basic science, clinical observation, and epidemiologic studies have all contributed to an emerging body of evidence on the potential role of flavonoids, a group of polyphenolic compounds with antioxidant properties, in the prevention of cardiovascular disease. However, the few existing studies on flavonoids or its food sources have provided inconsistent results, usually focusing on the primary prevention of coronary heart disease mortality. The study used the small grant mechanism (R03) to analyze previously collected data.

DESIGN NARRATIVE:

The investigators examined whether flavonoid intake was associated with the risk of incident CVD, and whether specific food sources of flavonoids--including tea, onions, apples, red wine, and other foods--were associated with the risk of incident CVD. The investigators processed and analyzed previously collected data of 39,876 middle-aged and older women free of CVD; the Women's Antioxidant Cardiovascular Study (WACS), a prospective study of 8,171 middle-aged and older women with pre-existing CVD or more than three coronary risk factors; the Normative Aging Study (NAS), a prospective study of 2,280 middle-aged and older men; and the Boston Area Health Study (BAHS), a case-control study of first nonfatal myocardial infarction in men and women aged less than 76 years. Using data from semiquantitative food frequency questionnaires administered in each study, the investigators determined individual intake of flavonoids and its food sources. Unlike previous studies, they examined flavonoids in relation to both the primary and secondary prevention of incident cardiovascular disease (CVD), consisting of confirmed cases of nonfatal myocardial infarction (Ml), nonfatal stroke, revascularization procedures, and CVD death.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Brigham and Women's Hospital
name: Howard Sesso
References:
citation: Sesso HD, Liu S, Gaziano JM, Buring JE. Dietary lycopene, tomato-based food products and cardiovascular disease in women. J Nutr. 2003 Jul;133(7):2336-41. doi: 10.1093/jn/133.7.2336.
citation: Sesso HD, Gaziano JM, Liu S, Buring JE. Flavonoid intake and the risk of cardiovascular disease in women. Am J Clin Nutr. 2003 Jun;77(6):1400-8. doi: 10.1093/ajcn/77.6.1400.
Clinical trial NCT01950104: Day 3 Embryo Biopsy Versus Blastocyst Biopsy in PGS Cases
Official title: Comparative Study Between Day 3 Embryo Biopsy and Blastocyst Biopsy in Preimplantation Genetic Screening Cases
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Infertility
Embryo Biopsy
Keywords: Embryo biopsy
Blastocyst stage
Day 3
Preimplantation genetic screening
Lead sponsor: Vida Recoletas Sevilla
Sponsor class: OTHER
First posted: 2013-09-25
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Preimplantation genetic diagnosis (PGS) is a technique that allow us to improve the results of assisted reproduction techniques through the selection of embryos free of chromosomal abnormalities.

At present, it has not been proved that the usage of PGS really improves the live birth rate in IVF cycles. However, it has been stated that the reason of not having better results when using PGS is that the methodology applied is not adequate.

Several authors propose that the optimal methodology for PGS includes the application of comparative genomic hybridization (CGH) arrays for genetic testing and carrying out embryo biopsy at the blastocyst stage. Nevertheless, most IVF centres still applies the day 3 embryo biopsy as a daily routine. Despite this fact, there is a gradual transition towards the usage of blastocyst-stage biopsy instead of day 3 biopsy.

The purpose of this clinical study is analysing the results of the IVF cycles with embryo biopsy for PGS. Live birth rates and other parameters as the pregnancy and implantation rates together with embryo quality will be analysed and compared between two groups of patients undergoing IVF cycles with PGS. In one group the biopsy will be applied in day 3 of the embryo development, while in the other group the embryo biopsy will be fulfilled at the blastocyst stage.


Eligibility criteria: Inclusion Criteria:

Patients under 49 years undergoing IVF cycles with PGS for one of the following reasons:

* Advanced maternal age
* Recurrent implantation failure
* Recurrent abortion
* Severe male-factor infertility

Exclusion Criteria:

* Not being able to sign the informed consent to participate in the study
* Patients undergoing preimplantation genetic diagnosis

Primary outcomes:
measure: Live birth rate
timeFrame: 20 months
Secondary outcomes:
measure: Fertilization rate
timeFrame: 1 year
measure: Embryo quality
timeFrame: 1 year
measure: Implantation rate
timeFrame: 1 year
measure: Pregnancy rate
timeFrame: 20 months
Other outcomes:
Locations:
city: Seville
country: Spain
facility: IVI Sevilla
Study officials:
References:
Clinical trial NCT05114304: Prevalence of Mood and Anxiety Disorders in Adult Patients With Pulmonary Langerhans Cell Histiocytosis
Official title: Prevalence of Mood and Anxiety Disorders in Adult Patients With Pulmonary Langerhans Cell Histiocytosis: an Exploratory Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pulmonary Langerhans Cell Histiocytosis
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2021-11-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with pulmonary Langerhans cell histiocytosis

Brief summary: Pulmonary Langerhans cell histiocytosis (PLCH) is a rare disease, of unknown etiology, that occurs almost exclusively in smokers.The clinical experience suggests a high prevalence of anxiety symptoms and an addictive profile. However, no study to date has precisely investigated the prevalence of co-morbid psychiatric disorders in this population.The aim of the study is to evaluate the prevalence of co-morbid psychiatric disorders in adult PLCH patients.

This study should allow:

* to assess the prevalence of psychiatric disorders co-morbid in PLCH patients
* a targeted and more effective management of patients
* a better response rate to smoking and cannabis weaning, that represents a major goal for these patients.


Eligibility criteria: Inclusion Criteria:

* Patients of 18 years of age or older with PLCH diagnosed at adulthood
* Patients affiliated to the French Health Care System
* Informed patients

Exclusion Criteria:

* Patient unable to understand the interview (language barrier)
* Patient under guardianship or curatorship
* Patient under AME (French medical help for foreigners)

Primary outcomes:
measure: Proportion of patients with at least one of the disorders detailed in the Mini International Neuropsychiatric Interview (MINI) test
timeFrame: at inclusion
Secondary outcomes:
measure: Proportion of patients with at least one comorbid addictive disorder among: tobacco, alcohol, cannabis, benzodiazepines, cocaine, opiates
timeFrame: at inclusion
measure: Proportion of patients with active tobacco consumption with or without comorbid psychiatric disorder
timeFrame: at inclusion
measure: Proportion of patients with persistent tobacco consumption despite nicotine replacement treatment
timeFrame: at inclusion
measure: Number of previous tobacco weaning episodes and co-morbid psychiatric disorders
timeFrame: at inclusion
measure: Number of co-morbid psychiatric disorders
timeFrame: at inclusion
measure: Factors associated with psychiatric disorders as assessed by Mini International Neuropsychiatric Interview (MINI) test
timeFrame: at inclusion
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Saint-Louis, Centre de référence national des histiocytoses, Service de Pneumologie
Study officials:
References: