louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05866627: A Study to Assess the Effect of Famotidine on the Drug Levels of Afimetoran in Healthy Participants
Official title: A Phase 1 Open-label, 2-Part Crossover Study to Assess the Effect of Acid-reducing Agent Famotidine on the Pharmacokinetics of Afimetoran (BMS-986256) in Healthy Participants
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: BMS-986256
Famotidine
Gastric pH
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2023-05-19
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to confirm there is no significant effect of gastric pH changes of famotidine on the drug levels of afimetoran in healthy participants.


Eligibility criteria: Inclusion Criteria:

* Weight ≥ 50 kilograms (kg), at screening and first admission, and body mass index between 18.0 kilogram per square meter (kg/m\^2) and 32.0 kg/m\^2, inclusive, at screening.
* A negative QuantiFERON-TB Gold test result at screening or documentation of a negative result within 3 months before screening.
* Normal renal function at screening as evidenced by an estimated glomerular filtration rate (eGFR) ≥ 80 milliliter per minute (mL/min)/1.732 m\^2 calculated with the Chronic Kidney Disease Epidemiology Collaboration formula.

Exclusion Criteria:

* Any significant acute or chronic medical illness.
* Current or recent (within 3 months of study drug administration) gastrointestinal (GI) disease that could impact upon the absorption of study treatment.
* GI surgery, including cholecystectomy, that could impact upon the absorption of study treatment, at the investigator's discretion.

Primary outcomes:
measure: Maximum observed plasma concentration (Cmax)
timeFrame: Up to 20 Days
measure: Time to attain maximum observed plasma concentration (Tmax)
timeFrame: Up to 20 Days
measure: Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC[0-T])
timeFrame: Up to 20 Days
Secondary outcomes:
measure: Number of participants with adverse events (AEs)
timeFrame: Up to 52 Days
measure: Number of participants with clinical laboratory abnormalities
timeFrame: Up to 52 Days
measure: Number of participants with vital sign abnormalities
timeFrame: Up to 52 Days
measure: Number of participants with electrocardiogram (ECG) abnormalities
timeFrame: Up to 52 Days
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Quotient Sciences
state: Nottinghamshire
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT00294827: Liver Transplantation and Metastatic Colo-rectal Cancer.
Official title: Liver Transplantation and Metastatic Colo-rectal Cancer.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Colo-rectal Cancer
Keywords: Liver transplantation
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2006-02-22
Enrollment: 25
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: Survival of colo-rectal cancer patients after liver transplantation.

Detailed description: Survival, time to progression, other malignancy, side-effects, quality of life.

Eligibility criteria: Inclusion Criteria:Colo-rectal cancer -

Exclusion Criteria:

-

Primary outcomes:
measure: Survival
timeFrame: 6 years
Secondary outcomes:
measure: Time to progression side-effects
timeFrame: 6 years
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Rikshospitalet-Radiumhospitalet HF
Study officials:
affiliation: Rikshospitalet-Radiumhospitalet RRHF
name: Svein Dueland, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Foss A, Adam R, Dueland S. Liver transplantation for colorectal liver metastases: revisiting the concept. Transpl Int. 2010 Jul;23(7):679-85. doi: 10.1111/j.1432-2277.2010.01097.x. Epub 2010 Apr 30.
Clinical trial NCT03371927: Effect of SINC Feeding Protocol on Weight Gain, Transition to Oral Feeding and the Length of Hospitalization
Official title: Effect of SINC Feeding Protocol on Weight Gain, Transition to Oral Feeding and the Length of Hospitalization in Premature Infants: Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Feeding; Difficult, Newborn
Keywords: Premature Infants
SINC feeding protocol
Lead sponsor: Selcuk University
Sponsor class: OTHER
Collaborators: name: The Scientific and Technological Research Council of Turkey
First posted: 2017-12-13
Enrollment: 76
Sex: ALL
Minimum age (years): 24
Maximum age (years): 33
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Feeding is one of the most common problems encountered by preterm infants. Besides, effective and safe feeding is one of the important discharge criteria. Feeding problems of premature infants lead to prolonged hospitalization and increased healthcare cost. SINC feeding protocol was developed based on evidence-based feeding protocol (such as cue-based, infant-driven feeding) and individualized developmental care.

The aim of the study is to determine the effect of the SINC feeding protocol on weight gain, transition to oral feeding and the length of hospitalization in premature infants according to traditional feeding method.

Randomized controlled study, including 30 infants of 28-33+6 weeks gestation receiving either Standard Feeding or SINC Feeding Protocol.


Eligibility criteria: Inclusion Criteria:

Having been born between 24-33+6 weeks of gestational age 28-33+6 postmenstrual weeks Monitoring with the diagnosis of healthy preterm infants

Exclusion Criteria:

* Receiving mechanical ventilation
* Congenital anomalies
* Having a surgical operation
* Having serious health problems

Primary outcomes:
measure: Weight Gain
timeFrame: from birth to discharge (average 15 weeks)
Secondary outcomes:
measure: Transition to Oral Feeding
timeFrame: from birth to discharge (average 15 weeks)
Other outcomes:
measure: Length of Hospitalization
timeFrame: from birth to discharge (average 15 weeks)
Locations:
city: Konya
country: Turkey
facility: Selcuk University Medical Faculty Hospital
state: Selcuklu
Study officials:
affiliation: Selcuk University
name: Raziye CELEN, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Selcuk Universiy
name: Fatma TAS ARSLAN, Ass.Prof.
role: STUDY_DIRECTOR
affiliation: Selcuk University
name: Hanifi SOYLU, Prof
role: STUDY_DIRECTOR
References:
Clinical trial NCT05577273: Does Antibiotic Prophylaxis at Urinary Catheter Removal Prevent Urinary Tract Infections
Official title: Does Antibiotic Prophylaxis at Urinary Catheter Removal Prevent Urinary Tract Infections
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Urologic Diseases
Urinary Tract Disease
Lead sponsor: Clalit Health Services
Sponsor class: OTHER
First posted: 2022-10-13
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 arms: antibiotic prophylaxis vs no treatment
Primary purpose: PREVENTION

Brief summary: At the end of most urological procedures, the doctor inserts a urethral catheter for a period of up to 5 days. According to AUA's guidelines, prophylactic antibiotic is indicated during catheter removal.

The aim of our study is to check the influence of the antibiotic treatment on urinary tract infections after catheter removal


Eligibility criteria: Inclusion Criteria:

* performing urological operation for other reason

Exclusion Criteria:

* cannot give informed consent
* \<18 years

Primary outcomes:
measure: UTI
timeFrame: 30 day
Secondary outcomes:
measure: positive culture approved UTI
timeFrame: 30 day
measure: Hospitalizations due to UTI
timeFrame: 30 day
measure: Bacteremia
timeFrame: 30 day
Other outcomes:
Locations:
city: Kfar-Sava
country: Israel
facility: Meir Medical Center
Study officials:
References:
Clinical trial NCT05325073: Erythropoietin Therapy to Induce Regulatory T Cells in Liver Transplant Recipients
Official title: Erythropoietin Therapy to Induce Regulatory T Cells in Liver Transplant Recipients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Liver Transplant Rejection
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2022-04-13
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The hypothesis of this proof-of-concept study is that EPO increases the frequency, stability and/or function of Tregs in liver transplant recipients. We also hypothesize that EPO will have a greater effect in everolimus vs. tacrolimus treated LTR, thus providing the rationale for a subsequent clinical trial to utilize EPO in combination with everolimus as a more successful pathway toward tolerance.


Eligibility criteria: Inclusion Criteria:

* Male or female
* Age 18-74 years
* History of liver transplantation \> 2 years prior for non-immune causes
* Use of immunosuppressive monotherapy (either tacrolimus or everolimus) for treatment of liver transplantation
* Stable immunosuppression regimen at least 3 months prior to enrollment.
* Ability to provide verbal and written informed consent

Exclusion Criteria:

* • Hgb above average normal value (15.7 g/dL in men, 13.8 g/dL in women); ALT \> 2 times upper limit of normal; uncontrolled hypertension with SBP\>160 or DBP\>100; end-stage renal disease on hemodialysis; history of venous thromboembolism including deep vein thromboses or pulmonary emboli, stroke, heart failure, seizure disorder, significant cardiovascular disease including a history of myocardial infarction, pure red cell aplasia, intolerance or allergy to erythropoietin; Active malignancy (untreated or undergoing therapy); known hypersensitivity to mammalian cell-derived products; known hypersensitivity to human albumin; presence of vascular access; prior recipient of erythropoietin within 12 weeks of the study; and pregnancy

  * Patient unable to provide consent including infants, children, teenagers, prisoners, cognitively impaired adults.
  * Prisoners and other vulnerable populations will also be excluded

Primary outcomes:
measure: EPO effects on Treg induction
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Josh Levitsky, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01535573: Citalopram for Cocaine Dependence
Official title: Clinical Trial of Serotonin Medication Combination in Cocaine Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cocaine Dependence
Keywords: Cocaine
citalopram
treatment
serotonin
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2012-02-17
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a phase 2 clinical trial of citalopram pharmacotherapy for treatment of cocaine dependence. Using a double-blind, randomized controlled design, eligible cocaine dependent patients will be assigned equally to one of three medication conditions: placebo or the Selective serotonin re-uptake inhibitor (SSRI) agent, citalopram at either 20 mg per day or 40 mg per day. It is hypothesized that citalopram will reduce cocaine use and increase periods of sustained abstinence substantially more than placebo. Performance on a set of behavioral tasks of impulsivity will be analyzed as potential predictors of treatment response.


Eligibility criteria: Inclusion Criteria:

* between 18 and 60 years of age
* meet Diagnostic and Statistical Manual 4 (DSM-IV) criteria for current cocaine dependence
* be in acceptable health on the basis of interview, medical history and physical exam
* able to provide the names of at least 2 persons who can generally locate their whereabouts.

Exclusion Criteria:

* diagnosis of any psychoactive substance dependence other than cocaine, marijuana, or nicotine
* have a psychiatric disorder or neurological disease or disorder requiring ongoing treatment and/or making study participation unsafe
* medical conditions contraindicating citalopram pharmacotherapy
* taking medications known to have significant drug interactions with the study medication
* pregnant or nursing for female patients
* having plans to leave the immediate geographical area within 3 months

Primary outcomes:
measure: Number of Participants Who Are Cocaine Abstinent During the Last 2 Weeks of Treatment (Weeks 8-9), as Assessed by Urine Test
timeFrame: 9 weeks
Secondary outcomes:
measure: Proportion of Cocaine-positive Urines Per Week
timeFrame: 9 weeks
measure: Number of Participants With Cocaine-negative Urines Collected During Treatment Period
timeFrame: 9 weeks
measure: Retention as Assessed by Number of Participants Remaining in Treatment
timeFrame: 9 weeks
Other outcomes:
Locations:
city: Houston
country: United States
facility: UT-Houston Behavioral and Biomedical Sciences Building
state: Texas
Study officials:
affiliation: University of Texas at Houston
name: Joy M Schmitz, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06710873: Analysis of Clinical Application of China's First Batch of TYRX Absorbable Antibacterial Envelope
Official title: Analysis of Clinical Application of China's First Batch of TYRX Absorbable Antibacterial Envelope
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: CIED Infection
TYRX Absorbable Antibacterial Envelope
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2024-11-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who received the TYRX absorbable antimicrobial envelopes at our hospital from December 2023 to September 2024

Brief summary: This study is the first to use TYRX domesticly, reporting and summarizing its usage to validate its real-world effectiveness in CIED infection prevention.

Detailed description: This study is the first to use TYRX domesticly, reporting and summarizing its usage to validate its real-world effectiveness in CIED infection prevention.

Eligibility criteria: Inclusion Criteria:

* All patients who received the TYRX absorbable antimicrobial envelopes at our hospital from December 2023 to September 2024

Exclusion Criteria:

* Allergies to the envelope materials or antimicrobial drugs (minocycline and other tetracyclines, rifampin)
* Existing infections at the CIED implantation site
* Pregnant or breastfeeding women
* children and adolescents

Primary outcomes:
measure: CIED infection
timeFrame: three months post-surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun-Yatsen Memorial Hospital of Sun-Yatsen University
state: Guangdong
Study officials:
References:
Clinical trial NCT03748173: Infasurf®(Calfactant) Aerosol for Infants With Bronchiolitis-AERO-04
Official title: Infasurf®(Calfactant) Aerosol for Infants With Bronchiolitis-AERO-04 A Pilot Study of Aerosol Surfactant for Bronchiolitis in Infants
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Bronchiolitis
Lead sponsor: ONY
Sponsor class: INDUSTRY
First posted: 2018-11-20
Enrollment: 13
Sex: ALL
Minimum age (years): 0
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Delivery of aerosolized Infasurf to bronchiolitis patients with who are not on assisted ventilation can provide sufficient delivery of Infasurf to small airways to improve ventilation and thereby shorten the duration of the respiratory illness.

Detailed description: This pilot clinical trial will compare "usual care" to aerosolized Infasurf. The study objective is to determine

1. Do bronchiolitis patients tolerate aerosolized Infasurf?
2. Does aerosolized Infasurf induce an improvement in respiration?
3. If it does how large a dose is required to observe a positive effect?
4. Is the positive effect transient, if so what is the range of duration of the effect?
5. Does retreatment also result and a positive response?
6. Does aerosolized Infasurf result in more rapid sustained improvement? is superior to.

Eligibility criteria: Inclusion Criteria:

1. Infant ≤ 4 months of age admitted to the PICU with the clinical diagnosis of bronchiolitis
2. Severe illness as reflected by a bronchiolitis score ≥ 4 and requiring high flow nasal cannula or continuous positive airway pressure for respiratory support
3. Within 4 hours of PICU admission.

Exclusion Criteria:

1. Need for non-invasive BiPAP or invasive ventilation
2. Significant Co-morbidities

   1. Chronic lung disease (evidenced by supplemental oxygen, home ventilation, or chronic diuretic therapy for CLD)
   2. Unrepaired congenital heart disease
   3. Immune compromise
   4. Neuromuscular weakness
3. Tracheostomy
4. Influenza as the etiologic agent of bronchiolitis
5. Inability to stabilize the infant to a bronchiolitis score \< 8

Primary outcomes:
measure: Improvement in Respiratory Status
timeFrame: 24 hours post PICU admission
Secondary outcomes:
measure: Need of Respiratory support
timeFrame: 24 hours post PICU admission
Other outcomes:
measure: Dose as Measured as duration of the therapy
timeFrame: 24 hours post PICU admission
Locations:
city: Richmond
country: United States
facility: Children's Hospital of Richmond at VCU
state: Virginia
Study officials:
References:
Clinical trial NCT05079373: Study of Neurological Damage From Coronavirus Disease (COVID-19)
Official title: Study of Neurological Damage From Coronavirus Disease (COVID-19): Extraction of Quantitative Imaging Biomarkers for the Characterization of Pathological Profiles
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Keywords: COVID-19
SARS-COV-2
Central nervous system
Headache
Loss of smell
Coma
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2021-10-15
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patient having covid and presenting with neurological symptoms leading to an MRI.

Brief summary: The objective of this study is to support the exploration of the NEURO-COVID-19 database and in particular to carry out the post-treatments necessary to derive quantitative information on the characterization of the lesion load, in particular with regard to of the vascular tree


Eligibility criteria: Inclusion criteria:

* Adult patient (≥18 years old)
* COVID + patient presenting with neurological symptoms leading to an MRI.
* Patient taken care of in one of the care centers associated with this research
* Patient not having expressed his opposition, after information, to the reuse of his data for the purposes of this research.

Exclusion criteria:

* Patient who expressed his opposition to participating in the study
* COVID patient not having neurological symptoms or not having received an MRI
* Patient under guardianship or guardianship
* Patient under legal protection

Primary outcomes:
measure: Retrospective study of the neurological damage in patients with Covid-19
timeFrame: Files analysed retrospectively from January 01, 2020 to October 31, 2021 will be examined]
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service d'Imagerie 2 - Neuroradiologie et Radiologie Ostéo-articulaire - Hôpitaux Universitaires de Strasbourg
Study officials:
References:
Clinical trial NCT00329173: PULSAR - A Prospective Study to Evaluate the Utility of Low Doses of the Statins Atorvastatin and Rosuvastatin.
Official title: A 6-Week Open-Label, Randomised, Multicentre, Phase IIIb, Parallel-Group Study to Compare the Efficacy and Safety of Rosuvastatin (10 mg) With Atorvastatin (20 mg) in Subjects With Hypercholesterolaemia and Either a History of CHD or Clinical Evidence of CHD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypercholesterolaemia
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-05-24
Enrollment: 1000
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: To compare reduction of LDL-C and safety between 10mg rosuvastatin and 20mg atorvastatin after 6 weeks treatment


Eligibility criteria: Inclusion Criteria:

* Male or female 18 or over.
* A history of CHD or clinical evidence of atherosclerosis (diabetic or non-diabetic) or a CHD risk equivalent (10-year risk score \> 20% for CHD as described in NCEP ATP III guidelines1.

Exclusion Criteria:

* History of statin induced myopathy, or serious hypersensitivity reaction to other HMG-CoA reductase inhibitors (statins), including rosuvastatin
* Pregnancy
* History of homozygous familial hypercholesterolaemia.

Primary outcomes:
measure: Reduction in LDL-c after 6 weeks
Secondary outcomes:
measure: Changes in other lipids and lipoproteins
measure: Achievement of NCEP -ATP III target goal LDL-Cholesterol and non HDL-C
measure: Achievement of EAS LDL-c and non HDL-C target goals after 6 weeks treatment.
measure: Comparison of cost effectiveness and also safety
Other outcomes:
Locations:
Study officials:
affiliation: AstraZeneca
name: Crestor Medical Science Director, MD
role: STUDY_DIRECTOR
References: