louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01079338: Salivary Proteome and Sensitivity to Bitterness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: sensitivity to caffeine
Lead sponsor: Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
Sponsor class: OTHER
First posted: 2010-03-03
Sex: MALE
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Primary purpose: BASIC_SCIENCE

Brief summary: This study aims to establish whether the protein composition of healthy males contribute to their sensitivity to the bitterness of caffeine.


Eligibility criteria: Inclusion Criteria:

* healthy volunteers

Exclusion Criteria:

* smokers
* currently suffering from oral pathologies
* sensory aversion to bitterness

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Institut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement
name: Martine Morzel, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03681938: Indication to Transplant Patients With High Risk B Cells Lymphoma in Metabolic Complete Remission?
Official title: Indication to Transplant Patients With High Risk B Cells Lymphoma in Metabolic Complete Remission After 2 Cycles of Chemotherapy ?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lymphoma, B-Cell
Lead sponsor: Institut Paoli-Calmettes
Sponsor class: OTHER
First posted: 2018-09-24
Enrollment: 183
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients With High Risk Big B Cells Lymphoma

Brief summary: The autograft of patients with prognostically unfavourable B-cells lymphoma cells in first remission remains controversial, in particular since the association of Rituximab with chemotherapy. Even though many randomized and non-randomized studies have been conducted, their is still no standard procedure . Recently, the use of early TEP (positron emission topography) answer, after 2 in 3 cures of chemotherapy allowed to select the poor-responder patients who remain candidate to autograft in front-line. Nevertheless, in good-responder patients, the benefits of an intensification therapy ins term of long-lasting disease control remains discussion.

This institutional retrospective study aims at comparing the outcome of early metabolic responder patients who received an intensification treatment to those who received a standard chemotherapy.


Eligibility criteria: Inclusion Criteria:

* Patients with High Risk Big B Cells Lymphoma
* Age \> 18 years

Exclusion Criteria:

* Not applicable

Primary outcomes:
measure: Compare the survival without progress of transplanted patients versus not transplanted patients
timeFrame: From the date of complete remission post C2 of chemotherapy up to 120 months
Secondary outcomes:
measure: Cumulative Relapse Incidence
timeFrame: From the date of complete remission post C2 of chemotherapy up to 120 months
measure: Overall survival
timeFrame: From the date of complete remission post C2 of chemotherapy up to 120 months
Other outcomes:
Locations:
city: Marseille
country: France
facility: Institut Paoli-Calmettes
Study officials:
affiliation: Institut Paoli-Calmettes
name: BOUABDALLAH Réda, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03923738: A Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Tocilizumab (TCZ) Administered to Participants With Giant Cell Arteritis (GCA).
Official title: A Phase Ib, Open-Label, Dose-Ranging Study to Evaluate the Pharmacokinetics, Pharmacodynamics, and Safety of Tocilizumab Administered by Intravenous Infusion to Patients With Giant Cell Arteritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Giant Cell Arteritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2019-04-23
Enrollment: 24
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the pharmacokinetics, pharmacodynamics, and safety of two dose levels of tocilizumab (TCZ) administered by intravenous (IV) infusion every 4 weeks (Q4W) to participants with giant cell arteritis (GCA).


Eligibility criteria: Inclusion Criteria:

* Diagnosis of GCA as classified according to protocol-specified criteria;
* Participants entering Period 1 must be receiving treatment with TCZ 8 mg/kg IV Q4W.

Exclusion Criteria:

* Treatment with any other investigational agent besides TCZ within 12 weeks (or 5 half-lives of the investigational drug, whichever is longer) prior to screening;
* Evidence of serious uncontrolled disease;
* Known active current or history of recurrent bacterial, viral, fungal, mycobacterial, or other infections;
* Active TB requiring treatment within the previous 3 years.

Primary outcomes:
measure: Maximum Serum Concentration (Cmax) of TCZ
timeFrame: Baseline; Weeks 4, 8, 12, 16-24
measure: Trough Serum Concentration (Ctrough) of TCZ at Steady State
timeFrame: Baseline; Weeks 4, 8, 12, 16-24
measure: Area Under the Concentration-Time Curve Over the Dosing Interval of 4 Weeks (AUC4weeks) of TCZ at Steady State
timeFrame: Baseline; Weeks 4, 8, 12, 16-24
measure: Percentage of Participants With Adverse Events
timeFrame: Baseline - Day 151
Secondary outcomes:
measure: Serum Concentration of Interleukin-6 (IL-6)
timeFrame: Baseline; Weeks 12, 16, 20, 24
measure: Serum Concentration of Soluble Interleukin-6 Receptor (sIL-6R)
timeFrame: Baseline; Weeks 12, 16, 20, 24
measure: Serum Concentration of C-Reactive Protein (CRP)
timeFrame: Baseline; Weeks 4, 8, 12, 16-24
measure: Erythrocyte Sedimentation Rate (ESR)
timeFrame: Baseline; Weeks 4, 8, 12, 16-24
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Universitätsspital Basel; Rheumatologie
city: Bern
country: Switzerland
facility: Inselspital Bern; Rheumatologie; Klinische Immunologie und Allergologie
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Schmitt C, Brockwell L, Giraudon M, Zucchetto M, Christ L, Bannert B, Daikeler T, Villiger PM. Intravenous tocilizumab for the treatment of giant cell arteritis: a phase Ib dose-ranging pharmacokinetic bridging study. Arthritis Res Ther. 2022 Jun 4;24(1):133. doi: 10.1186/s13075-022-02815-9.
Clinical trial NCT01592838: Impact on Quality of Hospital Care During Pre- and Post- Rotavirus (RV) Vaccination Introduction in Belgium
Official title: Feasibility Pilot Study Assessing the Impact on the Quality of Hospital Care After the Introduction of Rotavirus Vaccination in Belgium
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infections, Rotavirus
Keywords: Belgium
Quality of hospital care
Rotavirus vaccination
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2012-05-07
Enrollment: 1
Sex: ALL
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children ≤15 years old hospitalised for any reason between June 2004 and May 2010.

Brief summary: This study aims to investigate whether a change in the pattern of hospitalisation was observed in paediatric wards over the last 6 years (June 2004 - May 2010), whether a change in staff workforce availability was observed in paediatric wards over the last 6 years (during a whole year or during specific time periods of the year) and if changes of any of the variables measured during the observation period could be linked to the introduction of rotavirus vaccination.

Detailed description: This retrospective study will use data extracted from hospital databases during the period of the 1st of June 2004 until the 31st of May 2010. A coded list of all hospitalisations and of the different infection tests performed in children will be generated, together with a list of Full time equivalents (FTE) in paediatric ward and the number of sick leave days of the working personnel.

Eligibility criteria: Inclusion Criteria:

* All children aged ≤15 years being hospitalised (with overnight stay or day clinic) for whatever reason during the study period

Exclusion Criteria:

* Not Applicable

Primary outcomes:
measure: Determination of changes in hospitalisation pattern and workforce availability at the level of a pediatric ward in a hospital setting.
timeFrame: During the study period (from June 1st 2004 up to 6 years)
Secondary outcomes:
measure: Expression of the changes into a quality of hospital care score that can be easily applied in different hospital settings.
timeFrame: During the study period (from June 1st 2004 up to 6 years)
measure: Determination through factor and regression analysis which variable influences most the score in order to improve the score calculation.
timeFrame: During the study period (from June 1st 2004 up to 6 years)
measure: Investigation of whether a change in the quality of hospital care score could be linked to the introduction of rotavirus vaccination.
timeFrame: During the study period (from June 1st 2004 up to 6 years)
measure: Observation of other changes in the hospital organisation as a consequence of a change in the quality of hospital care score.
timeFrame: During the study period (from June 1st 2004 up to 6 years)
Other outcomes:
Locations:
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT01198938: Postoperative Melatonin Administration and Delirium Prevention in Patients Undergoing Vascular and Cardiac Surgery
Official title: Postoperative Melatonin Administration and Delirium Prevention in Patients Undergoing Vascular and Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Surgery
Keywords: Cardiac surgery, delirium, melatonin
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2010-09-10
Enrollment: 100
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The investigators plan to evaluate the effect of postoperative melatonin administration on postoperative delirium in patients undergoing vascular and cardiac surgery. A total of 302 patients older than 60, undergoing elective vascular surgery will be randomly divided into 2 groups: treatment and control. During the first 5 postoperative days patients will receive sublingually either melatonin 5 mg or placebo at 9:00 pm. The patients will be assessed for the signs of delirium, quality of sleep and severity of pain daily for the first postoperative week. Screening of delirium will be performed by the specially trained research assistant and based on the Confusion Assessment Method and the validated chart review. Diagnosis of delirium will be confirmed by the psychiatrist. Incidence of delirium will be compared between the groups.


Eligibility criteria: Inclusion Criteria:

* Non-emergent vascular surgery, with an expected length of stay ≥ 48hours, ASA categories I to IV, signed informed consent, age \>60

Exclusion Criteria:

* Lack of informed consent, ASA category V, history of psychiatric illness (schizophrenia, psychosis, bipolar disorder, major depression), Mini Mental State Examination score (MMSE) ≤ 24, history of autoimmune disease, liver cirrhosis, minimally invasive procedures (endovascular aneurysm repair ), history of chronic insomnia, chronic benzodiazepines and/or hypnotics use ( \> 3 times /week during a month prior to surgery), treatment with tricyclic antidepressants within a month prior to surgery, history of seizures, allergy to placebo ingredients or melatonin ( WN Pharmaceuticals.LTD), melatonin consumption in the last months prior to surgery.

Primary outcomes:
measure: Incidence of postoperative delirium
timeFrame: preoperative assessment up to 7 days postoperatively
Secondary outcomes:
measure: Pain score, using the standard 10-cm visual analog score (0-no pain, 10-worst, unbearable pain)
timeFrame: Preoperative assessment upt to 7 days postoperatively
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto General Hospital, UHN
state: Ontario
Study officials:
affiliation: Toronto General Hospital, UHn
name: Rita Katznelson, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04963738: A Study of JNJ-73763989 in Adult Participants With Renal Impairment
Official title: An Open-label, Single-dose, Parallel-group Study to Evaluate the Effect of Renal Impairment on the Pharmacokinetics of JNJ-73763989 in Adult Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Renal Impairment
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2021-07-15
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to evaluate the pharmacokinetics (PK) of a single subcutaneous (SC) dose of JNJ-73763989 in adult participants with renal impairment compared with healthy participants with normal renal function.


Eligibility criteria: Inclusion Criteria:

* Must have stable renal function defined as a less than (\<) 20 percent (%) change in serum creatinine concentrations between screening and Day -1
* Concomitant medications should be stable for the previous 1 month and throughout the duration of the study
* Women, except for postmenopausal women, must have a negative highly sensitive serum (beta-human chorionic gonadotropin \[beta-hCG\]) at screening and urine (beta-hCG) pregnancy test on Day -1
* Must sign an informed consent form (ICF) indicating they understand the purpose of, and procedures required for the study and are willing to participate in the study
* Participants with kidney disease without dialysis using benzodiazepines, tricyclic antidepressants, and prescription opiates with a positive urine test for drugs prescribed by their physician may be included following prior discussion with the sponsor

Exclusion Criteria:

* Have kidney disease requiring dialysis
* Renal transplants, systemic lupus erythematosus, or participant with malignancy
* Known allergies, hypersensitivity, or intolerance to JNJ-73763989 or its excipients
* Received an experimental drug (including investigational vaccines) or used an experimental medical device within 1 month or within a period less than 10 times the drug's half-life, whichever is longer, before the administration of the study drug is scheduled
* Preplanned surgery or procedures that would interfere with the conduct of the study

Primary outcomes:
measure: Plasma Concentration of JNJ-73763989
timeFrame: Predose, up to 72 hours postdose (up to Day 4)
Secondary outcomes:
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Up to 42 days
measure: Number of Participants with AEs by Severity Grades
timeFrame: Up to 42 days
measure: Number of Participants with Abnormalities in Clinical Laboratory Tests, Electrocardiograms (ECGs), Vital Signs and Physical Examination
timeFrame: Up to 42 days
Other outcomes:
Locations:
city: Kiel
country: Germany
facility: CRS Clinical Research Services Kiel GmbH
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References:
Clinical trial NCT00158938: Clinical Study of the EASYTRAK 3 Spiral Fixation Coronary Venous Bipolar Pace/Sense Lead
Official title: Clinical Study of the EASYTRAK 3 Spiral Fixation Coronary Venous Bipolar Pace/Sense Lead
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Congestive Heart Failure
Keywords: Artificial Cardiac Pacemaker
Implanted Electrodes
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical investigation was to assess the safety and effectiveness of the EASYTRAK 3 lead

Detailed description: This clinical study was a prospective, multi-center, clinical evaluation to document safety and effectiveness of the EASYTRAK 3 lead in humans. Patients implanted with the EASYTRAK 3 lead were followed through pre-discharge, 1-month, 3-month and 6-month follow-ups

Eligibility criteria: Inclusion Criteria:

* Moderate to severe heart failure (NYHA Class III/IV) including left ventricular dysfunction (EF \<= 35%) and QRS duration \>= 120 ms remaining symptomatic despite stable, optimal heart failure drug therapy.
* Creatinine \< 2.5 mg/dL obtained no more than two weeks prior to enrollment.
* Age 18 or above, or of legal age to give informed consent specific to state and national law.
* Willing and capable of providing informed consent, undergoing a device implant, participating in all testing associated with this clinical investigation at an approved clinical investigational center and at the intervals defined by this protocol.

Exclusion Criteria:

* A known hypersensitivity to a 1.0 mg (0.5 mg per electrode) dose of dexamethasone acetate.
* Previous cardiac resynchronization therapy, a coronary venous pace/sense lead or attempted LV lead placement.
* Pre-existing cardioversion/defibrillation leads other than those specified in this investigational plan (unless the investigator intends to replace them with permitted cardioversion/defibrillation leads).
* Requiring dialysis.
* A myocardial infarct, unstable angina, percutaneous coronary intervention, or coronary artery bypass graft during the preceding 30 days prior to enrollment.
* Hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy (e.g., amyloidosis, sarcoidosis).
* A documented life expectancy of less than 6 months or expected to undergo heart transplant within 6 months.
* Enrolled in any concurrent study, without prior Guidant written approval, that may confound the results of this study.
* Have a mechanical tricuspid heart valve.

Primary outcomes:
measure: Pacing thresholds at 6 months
measure: Pacing impedances at 6 months
measure: R-wave amplitudes at 6 months
measure: 6-month complication free rate
Secondary outcomes:
measure: left ventricular bipolar pacing and sensing with RENEWAL 3 H173 safety
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01133938: Predictive Factors for the Development of Osteonecrosis After the Treatment of the Developmental Dislocated Hip
Official title: Predictive Factors for the Development of Osteonecrosis After the Treatment of the Developmental Dislocated Hip. A Comparison of Early Open Reduction Versus Late Open Reduction With Combined Pemberton and Femoral Osteotomies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Predictors of Osteonecrosis of the Femoral Head After Treatment of the Dislocated Hip
Lead sponsor: Orthopedic Hospital Vienna Speising
Sponsor class: OTHER
First posted: 2010-05-31
Enrollment: 79
Sex: ALL
Minimum age (years): 1
Maximum age (years): 15
Standard ages: CHILD
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive series of patients hospitalized because of developmental dislocated hip between 1198 and February 2007

Brief summary: Several risk factors for the development of osteonecrosis of the femoral head following treatment of developmental dislocated hip have been reported. The need for further research with a large-enough sample size including statistical adjustment of confounders was demanded. The purpose of the present study was to find reliable predictors of osteonecrosis in patients managed for developmental dislocation of the hip and to evaluate if delayed treatment increased the risk of residual acetabular dysplasia requiring secondary surgeries.


Eligibility criteria: Inclusion Criteria:

* Follow-up \> 3 years

Exclusion Criteria:

* teratological hip dislocation
* neuromuscular disease
* previous open reduction at another medical institution

Primary outcomes:
measure: Osteonecrosis of the femoral head
Secondary outcomes:
measure: Secondary reconstructive procedures due to residual acetabular dysplasia
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Orthopedic Hospital Vienna Speising
Study officials:
References:
Clinical trial NCT05279638: ATG5 as a Serum Marker of Autophagy in Psoriatic Patient
Official title: Evaluation of ATG5 as Aserum Marker of Autophgy in Psoriasis Vulgaris Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Psoriasis Vulgaris
Autophagy
Keywords: serum marker
ATG5
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-03-15
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with psoriasis vulgaris and healthy participatins

Brief summary: it will be of interest to know the ATG 5 as a serum marker of autophagy in serum of psoriasis vulgairs patients and explore its relationship with psoriasis severity.


Eligibility criteria: Inclusion Criteria:

Psoriasis vulgaris of both sex, age 18-55 years

Exclusion Criteria:

i. Patients with other types of psoriasis ii. Pregnant or lactating women iii. patients with hepatic or renal diseases iv. patients receive any systemic treatment in last 3 months

Primary outcomes:
measure: serum level of ATG5 in psoriatic patients
timeFrame: Within 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag University
Study officials:
References:
Clinical trial NCT03249038: Estimated Blood Loss: Novel Model for Estimating Surgical Blood Loss.
Official title: Estimated Blood Loss: Novel Model for Estimating Surgical Blood Loss.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blood Loss, Surgical
Blood Loss
Blood Loss, Postoperative
Lead sponsor: Hospital Clinic of Barcelona
Sponsor class: OTHER
First posted: 2017-08-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients scheduled for elective urologic laparoscopy surgery.

Brief summary: Estimated blood loss is an important parameter recognized as a standard practice in anesthesiology and others medical specialties, with relevant clinical and research applications. Currently is no model capable of accurately estimate blood loss. The purpose of this study is to evaluate the accuracy of a novel model.


Eligibility criteria: Inclusion Criteria:

* Patients scheduled for elective urologic laparoscopy surgery.

Exclusion Criteria:

* Patient with suspected or confirmed heart failure, severe hypertension, hepatic cirrhosis, chronic kidney disease on dialysis, coagulopathy, as well as patient receiving diuretics, anticoagulant or antiplatelet agents.
* Cases in which surgical gauzes were used, including conversion to open surgical technique. - Patients who have received transfusions of RBCs during the perioperative period.
* Patients who have showed postoperative bleeding, defined by an amount greater than 50 ml in surgical drains, or any other type of blood loss.

Primary outcomes:
measure: Hemoglobin mass lost
timeFrame: Intraoperative
measure: Postoperative serum hemoglobin concentration
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: