louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05289180: Brachial Right Ventricle - Endomyocardial Biopsy
Official title: A Novel Method for Cardiac Allograft Monitoring:Transbrachial Right Ventricle Endomyocardial Biopsy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Transplantation
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2022-03-21
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Right heart endomyocardial biopsy is classically approached via jugular or femoral access. Brachial access has not been widely studied and appears to be an efficient and safe method for performing endomyocardial biopsies. We hypothesize that transbrachial right endomyocardial biopsy is a safe, comfortable and equally effective procedure to endomyocardial biopsies via classical access methods. This single arm study will focus on brachial endomyocardial biopsy and will be compared with historical data.

Brief summary: This is an observational study that will recruit NYU Langone patients undergoing standard of care right ventricle endomyocardial biopsy. Patients who undergo planned RV-EMB via transbrachial access will be invited to take part in the study.

Detailed description: Data including severity of tricuspid regurgitation and tamponade from pre and post procedure bedside echocardiograms, total procedure duration, radiation exposure and fluoroscopy time, sedatives used (if any) and bleeding/hematoma formation (if any) will be collected. A post-procedural survey will be administered to patients by study staff to assess comfort level and anxiety during procedure. A post procedure phone call will take place 3-5 days after procedure to assess for bruising, swelling or bleeding at the site of Brachial RV-EMB.

Eligibility criteria: Inclusion Criteria:

* Patient is 18 to 90 years old
* Patient is undergoing standard of care right heart catheterization with endomyocardial biopsy
* Patient has right arm brachial access available
* Patient is willing and able to provide written informed consent.

Exclusion Criteria:

* Peripherally inserted central catheter (PICC) line or arteriovenous (AV) fistula
* Severe untreated tricuspid valve regurgitation
* Female patients who are pregnant

Primary outcomes:
measure: Patient Satisfaction in Right endomyocardial biopsy via brachial access
timeFrame: Day 1 to Day 540
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Tajinderpal Saraon
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01433380: A Study To Evaluate PF-05175157 In Healthy Volunteers
Official title: Phase 1 Study To Evaluate The Effect Of Single Doses Of Pf-05175157 On Pharmacodynamic And Metabolic Parameters In Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 2
Keywords: Phase 1
Single Doses
Pharmacodynamics
Healthy Volunteers
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-09-13
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The primary purpose of this study is to evaluate the pharmacodynamics of single oral doses of PF-05175157 in healthy volunteers


Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive.
* Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests.
* In addition, subjects must have normal pulmonary function tests and normal ocular examination.
* Body Mass Index of 20.0 35.0 kg/m2; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* Evidence or history of any chronic ongoing or current pulmonary disease.
* History of smoking in the past 5 years or history or evidence of habitual use of other (non smoked) tobacco or nicotine-containing products within 3 months of Screening or positive cotinine test at Screening or Day 0.
* Active ocular disease including infection, glaucoma, seasonal allergies, dry eye symptoms or retinal/optic nerve disease.

Primary outcomes:
measure: Changes in carbohydrate and lipid metabolism
timeFrame: 24 hours
Secondary outcomes:
measure: Pharmacokinetics: 0.5, 1, 1.5, 2.5, 6.5, 10.5, 24 hrs after dosing, parameters: Cmax, Tmax and Area under the Curve (AUC)
timeFrame: 24 hours
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Pfizer Investigational Site
state: Louisiana
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT04600180: The Gut Immune System During Immune Checkpoint Inhibitor Therapy
Official title: Deep Phenotyping of the Gut Immune System During Immune Checkpoint Inhibitor Therapy - DEFENCE
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
Keywords: Immune Checkpoint Inhibitor
Cancer
Gut Wall
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2020-10-23
Enrollment: 38
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 cancer and an indication for palliative treatment with immune checkpoint inhibitors.

Brief summary: This exploratory study aims to gain insight in gut immune system phenotypes before and after immunotherapy. After informed consent is obtained, sigmoidoscopies at baseline and during treatment with immunotherapy will be performed, During the endoscopies, biopsies from the sigmoid and rectum will be obtained. Subsequent immune cell analyses in these biopsies will be performed. Parallel to the sigmoidoscopies, venous blood samples will be obtained to monitor inflammatory markers.


Eligibility criteria: Inclusion Criteria:

* Indication for treatment with anti PD1/PDL1 based immunotherapy
* Written informed consent
* Evaluable according to iRECIST v1.1

Exclusion Criteria:

* Concomitant, chronic or infectious illness in the past 6 months causing moderate to severe colitis
* Use of a medication in the past 6 months with an elevated risk of moderate to severe colitis
* Gastrointestinal resection or enterostomy
* Abdominal radiotherapy in the past 6 months

Primary outcomes:
measure: CD8+ T cell count in the gut mucosa
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
affiliation: University Medical Center Groningen
name: Jacco J. de Haan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04164680: Simultaneously PET/MRI in Prolonged DOC Patients
Official title: Relationship Between Simultaneously Acquired Resting-state Regional Cerebral Glucose Metabolism and Functional MRI in DOC: a PET/MR Hybrid Scanner Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Disorder of Consciousness
Minimally Conscious State
FDG-PET
Rs-fMRI
Keywords: Disorder of Consciousness
Unresponsive wakefulness syndrome
Multimodal Neuroimaging
Lead sponsor: Hangzhou Normal University
Sponsor class: OTHER
First posted: 2019-11-15
Enrollment: 24
Sex: ALL
Minimum age (years): 16
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Distinguishing patients in unresponsive wakefulness syndrome, UWS \[i.e. patients showing eyes opening but no behavioral evidence of consciousness \] from patients in minimally conscious state, MCS \[i.e., patients showing minimal, inconsistent but clearly discernible intentional behaviors \] is pivotal for decision making in the entire care pathway of patients with DoC.

Brief summary: Recently introduced hybrid PET/MR scanners provide the opportunity to measure simultaneously, and in direct spatial correspondence, both metabolic demand and functional activity of the brain, hence capturing complementary information on the brain's physiological state. Here we exploited PET/MR simultaneous imaging to explore the relationship between the metabolic information provided by resting-state fluorodeoxyglucose-PET (FDG-PET) and fMRI (rs-fMRI) in patients with disorders of consciousness.


Eligibility criteria: Inclusion Criteria:

* DOC patients （acute, subacute or chronic period）: Coma, UWS and MCS.

Exclusion Criteria:

* neuromuscular blocking agents or sedative drugs administered within the prior 24 hours；
* unstable medical condition；
* mental implant in the brain

Primary outcomes:
measure: resting-state fMRI
timeFrame: Within 7 days
measure: fludeoxyglucose (FDG-)PET
timeFrame: Within 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: International Vegetative State and Consciousness Science Institute, Hangzhou Normal University
state: Zhejiang
Study officials:
References:
citation: Cavaliere C, Kandeepan S, Aiello M, Ribeiro de Paula D, Marchitelli R, Fiorenza S, Orsini M, Trojano L, Masotta O, St Lawrence K, Loreto V, Chronik BA, Nicolai E, Soddu A, Estraneo A. Multimodal Neuroimaging Approach to Variability of Functional Connectivity in Disorders of Consciousness: A PET/MRI Pilot Study. Front Neurol. 2018 Oct 18;9:861. doi: 10.3389/fneur.2018.00861. eCollection 2018.
Clinical trial NCT01814280: Reducing Medication Errors on Basis of an Individual Risk Assessment
Official title: Differentiated Intervention Aimed at Reducing Medication Errors on Basis of an Individual Risk Assessment - a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Drug Safety
Keywords: Medication errors
Medication review
Risk stratification
Patient safety
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
First posted: 2013-03-19
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Background:

Medication reviews performed on admission to hospitals reduce medication errors; however, evidence of effect on morbidity and mortality is currently inconsistent. It is known that patients' risks of experiencing medication errors are dependent on both patient- and drug factors, e.g. age, co-morbidity, number of drugs, risk of side effects.

Aim and hypothesis:

The aim of this pilot study is to study acute medical patients' risk of getting a medication error based on an algorithm that takes into account both patient and drug related factors. Secondary, the investigators will explore whether our methods are applicable in a randomised controlled trial. The investigators will also decide the number of patients in a randomised controlled trial based on this pilot study.

The hypothesis is that an algorithm that has already been developed can stratify patients according to their risk of experiencing a medication error.

Methods:

100 acute admitted patients will be risk stratified at admission (\>8 hours after). The patients who have highest risks of medication errors will receive a medication review performed by either a clinical pharmacist or a clinical pharmacologist.


Eligibility criteria: Inclusion Criteria:

* Acutely admitted patients
* Age\>17 years

Exclusion Criteria:

* Dying patients
* Suicial patients

Primary outcomes:
measure: Medication errors
timeFrame: During the patients' hospital stay
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital,
Study officials:
References:
Clinical trial NCT02971280: Influence of Heavy Metals Exposure on in Vitro Fertilization (IVF) Outcome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fertilization in Vitro
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2016-11-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: IVF patients (women and men)

Brief summary: Exposure to heavy metals may interfere with basic cellular functions, including DNA synthesis.

The aim of the study is to correlate heavy metals concentration in body fluids of reproductive importance and IVF outcome.

Detailed description: Concentration of heavy metals will be measured in blood, urine, semen fluid and follicular fluid of IVF patients.

Study group: poor prognosis patients: repeated IVF failure, implantation failure, poor ovarian response, low sperm quality (according to WHO criteria) Control group: Good prognosis patients. Normal sperm count. Heavy metals concentrations will be measured using atomic absorption spectrometer, and will be correlated with IVF outcomes: number of mature oocytes obtained, fertilizations, embryos quality, and reproductive outcome post embryo transfer.

Eligibility criteria: Inclusion Criteria

* Age of female patients: \<=39
* Age of male patients: 18-50

Exclusion Criteria:

* Smoking
* Alcohol/drug abuse
* Long-term/chronic medications
* Severe health/mental problems
* Dental or other transplants
* Fragile X mutations
* Fertility preservation

Primary outcomes:
measure: Live birth rate ("take-home baby")
timeFrame: 9 months from embryo transfer
Secondary outcomes:
measure: Clinical pregnancy rate
timeFrame: 1 month from embryo transfer
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01679080: The Effect of Treatment With Teriparatide and Zoledronic Acid in Patients With Osteogenesis Imperfecta
Official title: The Effect of Treatment With Teriparatide and Zoledronic Acid in Patients With Osteogenesis Imperfecta
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Osteogenesis Imperfecta
Keywords: Drug therapy
Adult
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2012-09-05
Enrollment: 9
Sex: ALL
Minimum age (years): 22
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Osteogenesis imperfecta (OI) is an inherited disease of the connective tissue. Symptoms are fractures, growth retardation, blue sclera, bad teeth, impaired hearing a.o. The aim of the present study is to investigate the effect of treatment of adult OI patients with bisphosphonate (zoledronic acid), parathyroid hormone (PTH) or placebo on bone mass, fracture risk and quality of life.

The investigators will therefore conduct a double blind, placebo controlled trial, taking genotype and previous antiresorptive therapy into account.


Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of osteogenesis imperfecta
* BMD\<-1.0 or

Exclusion Criteria:

* creatinine clearance \<30mL/min
* treatment with glucocorticoids \> 5mg daily during the last 3 months
* metabolic bone disease or vitamin d deficiency
* liver or kidney disease
* contradictions to zoledronic acid or teriparatide
* increased baseline risk of osteosarcoma

Primary outcomes:
measure: Bone Mineral Density (BMD)
timeFrame: Three years
Secondary outcomes:
measure: Fracture risk
timeFrame: Three years
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Osteoporosis clinic; department of endocrinology and metabolism
state: Aarhus C
city: Hvidovre
country: Denmark
facility: Department of endocrinology
city: Odense
country: Denmark
facility: Department of Endocrinology M
Study officials:
affiliation: Aarhus University Hospital
name: Bente Langdahl, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06607562: Effectiveness and Safety of Probiotics in Protecting Liver Function
Official title: Protective Effect of Probiotics BC99 on Liver Function in Long-Term Alcohol Consumers: A Randomized, Double-Blind, Placebo-Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alcohol Abuse
Lead sponsor: Wecare Probiotics Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-09-23
Enrollment: 80
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the effectiveness and safety of using probiotics to protect the liver function of long-term alcohol consumers


Eligibility criteria: Inclusion Criteria:

1. A history of long-term heavy alcohol consumption, equivalent to ethanol intake ≥40g/day for over 1 year. The conversion formula is: ethanol (g) = volume of ethanol-containing beverage (mL) × ethanol content (%) × 0.8 (specific gravity of ethanol);
2. Body Mass Index (BMI) between 18kg/m² and 25kg/m²;
3. Voluntarily signed a written informed consent form, agreeing to participate in this study;
4. Agreed to comply with the study protocol and restrictions;
5. Subjects (including male participants) have no plans for conception from 14 days prior to screening until 6 months after the end of the trial and voluntarily agree to use effective contraception.

Exclusion Criteria:

1. Patients with various types of viral hepatitis, autoimmune liver disease, drug-induced liver damage, vascular liver disease, genetic metabolic liver disease, or primary liver cancer;
2. Individuals who have recently consumed substances with similar functions to the tested product, potentially affecting the study results;
3. Patients with severe allergies or immune deficiencies;
4. Pregnant, breastfeeding, or women with plans for pregnancy;
5. Individuals with severe diseases of vital organs such as cardiovascular, pulmonary, hepatic, renal conditions, or those with diabetes, severe thyroid disorders, metabolic diseases, malignant tumors, or severe immune system disorders;
6. Individuals who have used antibiotics within the past two weeks;
7. Participants who did not comply with the required consumption of the tested product or missed follow-ups, making it impossible to evaluate the effectiveness;
8. Other participants deemed unsuitable by the researchers.

Primary outcomes:
measure: liver function changes
timeFrame: 56 days
Secondary outcomes:
Other outcomes:
Locations:
city: Luoyang
country: China
facility: Wu Ying
state: Henan
Study officials:
affiliation: Henan University of Science and Technology
name: Ying Wu, Dr.
role: STUDY_CHAIR
References:
Clinical trial NCT04134962: Evaluation of a New Tool for Measuring Hindfoot Alignment Under Load and in 3D.
Official title: Evaluation of a New Tool for Measuring Hindfoot Alignment Under Load and in 3D. 3D-HAM Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ankle Surgery
Foot Surgery
3D Imaging
Lead sponsor: Ramsay Générale de Santé
Sponsor class: OTHER
Collaborators: name: Dr François Lintz
First posted: 2019-10-22
Enrollment: 125
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's patients for which a Cone Beam under load is prescribed for a preoperative assessment of a foot or ankle surgery or for a follow-up consultation.

Brief summary: The automated TALAS measurement tool, working with the Cone Beam 3D scanner under load, provides a reproducible measurement of the Foot Ankle Offset (FAO). It is possible to determine an average value and the standard deviation of FAO in the relevant population. And to differentiate significantly the populations with a neutral alignment, varus or valgus.

Detailed description: The analysis of the alignment of the foot is fundamental in the management of pathologies of the foot and ankle. The advent of 3D imaging under load (Scanner Cone Beam), less radiant and more precise, requires the development and evaluation of new measurement tools.

The automated TALAS measurement tool, working with the Cone Beam 3D scanner under load, provides a reproducible measurement of the Foot Ankle Offset (FAO). It is possible to determine an average value and the standard deviation of FAO in the relevant population. And to differentiate significantly the populations with a neutral alignment, varus or valgus.

Eligibility criteria: Inclusion Criteria:

* Patient selected for a preoperative assessment in foot or ankle surgery, or patient seen in follow-up consultation for which a Cone Beam under load is prescribed
* Patient having been informed of this study and having given their consent
* Patient over 18 years old
* Unprotected adult

Exclusion Criteria:

* Patient with a contraindication to the Cone Beam under load
* Patient refusing to participate in this study
* Non-plantigrade foot under load (impossibility of simultaneously resting M1, M5 and Calcaneus on the ground)
* Patient who has already participated in the 3D HAM study (patients who would have participated in the study during the preoperative consultation for which another Cone Beam would be prescribed during the follow-up consultation. These patients would not be able to participate again in this study).

Primary outcomes:
measure: FAO value measured
timeFrame: 1 day
measure: FAO Reliability
timeFrame: 1 day
measure: FAO sensitivity-specificiy
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Saint-Jean
country: France
facility: Clinique de L'Union
Study officials:
References: