louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00807794: A Safety Clinical Trial of Different Doses of MEDI-507 in the Prevention of Acute Renal Allograft Rejection
Official title: Phase I Evaluation of the Pharmacokinetics, Pharmacodynamics and Safety of Different Doses of MEDI-507 in the Prevention of Acute Renal Allograft Rejection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Kidney Diseases
Lead sponsor: MedImmune LLC
Sponsor class: INDUSTRY
First posted: 2008-12-12
Enrollment: 13
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: To evaluate the clinical safety of different doses of MEDI-507 through day 33.

Detailed description: To evaluate the pharmacokinetic characteristics of MEDI-507 given in dose intervals.

Eligibility criteria: Inclusion Criteria:

* Renal allograft recipients receiving their first or second allograft
* Age over 18
* Maintained on conventional immunosuppression
* Completed informed consent document

Exclusion Criteria:

* Known hypersensitivity to MEDI-507
* More than two renal allografts
* Moribund and unlikely (in the opinion of the investigator) to survive the duration of the trial
* Simultaneous use of other investigational agents (this does not include the use of licensed agents for indications not listed in the package insert)
* Any of the following clinical settings or diagnoses posttransplant:

pregnancy or nursing mother: Ø Human Immunodeficiency Virus infection Ø hemodialysis or chronic peritoneal dialysis Ø use of a ventilator Ø hyperacute rejection

* Having received OKT3, tacrolimus, or antilymphocyte globulin during the current allograft
* Less than 10 ml/hr average urine output over 4 hours since the end of surgery

Primary outcomes:
measure: To evaluate the clinical safety of MEDI-507. Each adverse event will be reported by severity grade, relationship to study drug, organ system, and need for medical intervention.
timeFrame: Day 33
Secondary outcomes:
measure: To collect initial pharmacokinetic parameters, the incidence and time to first episode of acute rejection, the number of episodes of rejection and graft survival.
timeFrame: Day 33
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Bloomington
country: United States
facility: Indiana University
state: Indiana
city: San Antonio
country: United States
facility: San Antonio Community Hospital
state: Texas
city: Charlottesville,
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: MedImmune LLC
name: J. Bruce McClain, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT03626194: Prospective Evaluation of the Efficacy and Safety of Endoscopic Tissue Apposition
Official title: Prospective Evaluation of the Efficacy and Safety of Endoscopic Tissue Apposition
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Endoscopic Tissue Apposition
Endoscopic Suturing
Endoscopic Clipping
Bariatric Endoscopy
Transoral Outlet Reduction
Endoscopic Sleeve Gastroplasty
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2018-08-10
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A prospective database/registry of patients undergoing endoscopic tissue apposition will be formed. Women and minorities will be included as they are frequently found to have indications for which endoscopic tissue apposition may be indicated.

Brief summary: This study is a prospective registry of patients undergoing endoscopic suturing and/or clip placement at our institution to assess the efficacy and safety of endoscopic tissue apposition.

1.1 Hypothesis: Endoscopic tissue apposition is efficacious and safe in the practice of gastrointestinal endoscopy.

1.2 Aims: To prospectively evaluate the efficacy and safety of Endoscopic Tissue Apposition in the practice of gastrointestinal endoscopy.


Eligibility criteria: Inclusion Criteria:

* Patients\>18 years of age undergoing endoscopy for any of the following indications:

Indications for Tissue Apposition:

* Closure of perforations
* Closure of full thickness defects created during endoscopic full thickness resection
* Closure of defects after endoscopic submucosal dissection and endoscopic mucosal resection
* Closure of mucosotomy after Peroral Endoscopic Myotomy (POEM)
* Stent fixation
* Closure of fistulas
* Natural Orifice Transluminal Endoscopic Surgery defect closures
* Post-bariatric surgery gastrojejunal anastomosis and gastric pouch revision (transoral outlet repair)
* Primary endoscopic sleeve gastroplasty

Exclusion Criteria:

* Patients unable or unwilling to provide consent
* Pregnant patients
* Coagulation disorders (INR \>1.8, platelet \<50,000)
* GI Bleeding
* Hemodynamic instability
* Enrollment in another device or drug study that may confound the results

Primary outcomes:
measure: Technical and clinical success in endoscopic tissue apposition
timeFrame: From baseline to one year
measure: Adverse Events
timeFrame: From baseline to one year
Secondary outcomes:
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
Study officials:
References:
Clinical trial NCT06974994: Resilience to Antibiotic-induced Obesogenic Microbiota: Discovering Mechanism of Microbiota Modulation
Official title: Resilience to Antibiotic-induced Obesogenic Microbiota Vertically Transferred to the Neonatal Gut: Discovering Mechanism of Microbiota Modulation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Healthy Newborn Infants
Keywords: antibiotics
human milk oligosaccharides
probiotics
newborn
microbiome
microbiota
obesity
infectious diseases
Lead sponsor: Turku University Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Lallemand Health Solutions
First posted: 2025-05-16
Enrollment: 125
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, placebo-controlled trial
Primary purpose: OTHER

Brief summary: The aim is to study whether the microbiota of children who are exposed to antibiotics at birth could be modified by synbiotic supplement and thereby reduce the risk of obesity, chronic diseases and respiratory tract infections. A total of 125 mother-child pairs will be recruited in this randomized, double-blind, placebo-controlled study. Infants are randomized to receive either a synbiotic supplement or a placebo for 2 months, after which their growth and morbidity will be monitored at the research clinic for 2 years.


Eligibility criteria: Inclusion Criteria:

Pregnant women (n=125) and their newborn children who receive antibiotic treatment at delivery.

Exclusion Criteria:

* Chorioamnionitis
* Pre-eclampsia and hepatogestosis
* Suspected malformation or serious condition of the foetus and neonates
* Serious infection or other conditions not permitting breast milk feeding

Primary outcomes:
measure: BMI at 24 months of age
timeFrame: From enrollment to 24 months of age
Secondary outcomes:
measure: Height
timeFrame: From enrollment to 24 months of age
measure: Weight
timeFrame: From enrollment to 24 months of age
measure: Growth velocity
timeFrame: From enrollment to 3 months of age
measure: Child's microbiome
timeFrame: From enrollment to 24 months of age
measure: Mother's microbiome
timeFrame: From enrollment to 6 months after giving birth
measure: Breast milk microbiome
timeFrame: From enrollment to 6 months of age
measure: Hormonal levels
timeFrame: From enrollment to 6 months of age
measure: Inflammatory markers
timeFrame: From enrollment to 6 months of age
measure: Respiratory tract infections
timeFrame: From enrollment to 24 months of age
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Department of Paediatrics and Adolescent Medicine, Turku University Hospital and University of Turku
state: Valitse maakunta.
Study officials:
References:
Clinical trial NCT05349994: Extended Physiotherapy After Intensive Care Unit (ICU) Stay
Official title: Extended Physiotherapy After Intensive Care Unit (ICU) Stay: A Prospective Before and After Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Illness
Physical Disability
Keywords: Physical therapy
Physical function
Lead sponsor: Stockholm South General Hospital
Sponsor class: OTHER
First posted: 2022-04-27
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study design was a before and after study. A control group was included for three months and received standard care. An intervention group was then included for six months and received extended amount of physical therapy.
Primary purpose: TREATMENT

Brief summary: Patients in an Intensive Care Unit (ICU) are at great risk of muscle atrophy and neuromuscular complications, that could lead to respiratory complications, decreased physical functioning and deteriorated health related quality of life. The objective is to investigate if extended physical therapy in a general ward could lead to increased physical functioning for post-ICU patients.The study hypothesis is that extended physical therapy would lead to increased physical function at hospital discharge compared to standard amount of physical therapy.

Detailed description: The study design is a before and after study. A control group was included for three months and received standard amount of physical therapy at surgical wards, corresponding to 1.75 employment. An intervention group was then included for six months and received extended amount of physical therapy corresponding to an extra 0.5 employment for study participants (2-4 patients/day). The primary outcome was physical function measured with the Chelsea Critical Care Physical Assessment Tool (CPAx), in the ICU and the surgical ward.

Eligibility criteria: Inclusion Criteria:

* Age over 18 years
* ICU stay \>48 hours
* Understand the Swedish language

Exclusion Criteria:

• Patients palliative care with no intention of rehabilitation

Primary outcomes:
measure: Changes in physical function according to Chelsea Critical Care Physical Assessment tool (CPAx)
timeFrame: Through study completion, an average of 2 weeks per participant
Secondary outcomes:
measure: Feasibility of intervention
timeFrame: Through study completion, an average of 2 weeks per participant
measure: Length of stay at the ward
timeFrame: Through study completion, an average of 2 weeks per participant
measure: Readmission to ICU
timeFrame: Through study completion, an average of 2 weeks per participant
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Stockholm South General Hospital
Study officials:
affiliation: Stockholm South General Hospital
name: Katinka Siesage
role: PRINCIPAL_INVESTIGATOR
affiliation: Stockholm South General Hospital
name: Eva Alm- Joelsson
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03522194: Left Ventricular Diastolic Function During Anesthesia Induction
Official title: Influence of Left Ventricular Diastolic Function on Hemodynamic Stability During Anesthesia Induction and on Postoperative Complications
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Left Ventricular Diastolic Dysfunction
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2018-05-11
Enrollment: 200
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients scheduled for surgery under general anesthesia

Brief summary: Diastolic dysfunction is an important cause of hemodynamic instability in the perioperative field.Therefore this study aims to investigate the influence of existing diastolic dysfunction or deterioration of diastolic function on hemodynamic stability during induction of anesthesia and postoperative complications. The impact of different anesthetics on diastolic function is investigated.

Detailed description: In this prospective observational study two cohorts of patients with different anesthesia regimes are investigated. Anesthesia is maintained with sevoflurane or propofol. Before induction of anesthesia a transthoracic echocardiography is performed to examine systolic and diastolic function. Immediately after induction, during maintenance and after completion of anesthesia any changes of diastolic function are examined with transthoracic echocardiography. All anesthetic medications, fluids, vasoactive medications and catecholamines are registered.

Eligibility criteria: Inclusion Criteria:

* Patients older than 60 years scheduled for general anesthesia

Exclusion Criteria:

* Mitral regurgitation or stenosis \> I°
* Sp. mitral valve repair or replacement
* Pericardial effusion
* Atrial fibrillation/flutter
* Patients with pacemaker
* BMI \> 35 kg/m2

Primary outcomes:
measure: Norepinephrine
timeFrame: 30 minutes after induction of anesthesia
Secondary outcomes:
measure: e'
timeFrame: Directly after induction of anesthesia
measure: E / e'
timeFrame: Directly after induction of anesthesia
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
Study officials:
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Katharina Roeher, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kahl U, Vens M, Pollok F, Menke M, Duckstein C, Gruetzmacher J, Schirren L, Yu Y, Fischer M, Zollner C, Goepfert MS, Roeher K. Do Elderly Patients With Diastolic Dysfunction Require Higher Doses of Norepinephrine During General Anesthesia for Noncardiac Surgeries? A Prospective Observational Study. Anesth Analg. 2021 Feb 1;132(2):420-429. doi: 10.1213/ANE.0000000000005304.
Clinical trial NCT00534794: Study of Two Marketed Ocular Anti-Allergy Medications in Subjects With Allergic Conjunctivitis
Official title: A Single-Center, Masked, Randomized Study Comparing Two Marketed Ocular Anti-Allergy Medications in the Cat Room Model
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Allergic Conjunctivitis
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-09-26
Enrollment: 79
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: The purpose of this study is to compare the effects of two marked ocular anti-allergy medications in cat sensitive subjects with allergic conjunctivitis.


Eligibility criteria: Inclusion Criteria:

* Documented history of ocular allergy to cats.
* Positive skin prick allergen reaction to cat dander.

Exclusion Criteria:

* Use of any topical or systemic corticosteroids, immunosuppressive agents, antihistamines, decongestants, NSAIDs, or asprin during the two weeks prior to enrollment into the study.
* History of severe asthma, reactive airway disease or bronchial obstruction.
* Ocular surgery or trauma in the last year.

Primary outcomes:
measure: Change in Ocular Itch Score From Baseline
timeFrame: 0 hours, 12 hours
Secondary outcomes:
measure: Ocular Comfort Score at 12 Hours
timeFrame: 12 hours
Other outcomes:
Locations:
city: Boston
country: United States
facility: Ophthalmic Consultants of Boston
state: Massachusetts
Study officials:
affiliation: Ophthalmic Consultants of Boston
name: Michael Raizman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02647294: Polyunsaturated Fatty Acids in Patients With NAFLD.
Official title: Nutrition-based Therapy of Liver Disease of Different Origin: Effect of n-3 Polyunsaturated Fatty Acid in Patients With Nonalcoholic Fatty Liver Disease (NAFLD) and Metabolic Syndrome.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: NAFLD
Lead sponsor: General University Hospital, Prague
Sponsor class: OTHER
First posted: 2016-01-06
Enrollment: 60
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: Patients with metabolic syndrome and Nonalcoholic fatty liver disease (NAFLD) will be randomly allocated for the treatment with n-3 PUFA (3.6 g/day) or placebo for 12 months. At the beginning and at the end of the study basic clinical and anthropometric data, as well as parameters of liver steatosis and fibrosis will be tested.

Detailed description: Patients with metabolic syndrome and Nonalcoholic fatty liver disease (NAFLD) will be randomly allocated for the treatment with n-3 PUFA (3.6 g/day) or placebo for 12 months. At the beginning and at the end of the study basic clinical and anthropometric data will be recorded and the following parameters will be tested:

panel of biochemistry and liver function tests: triglycerides, cholesterol, HDLcholesterol, LDL-cholesterol, glucose, insulin, serum bilirubin, liver tests, thyroid hormones, bile acids and their metabolites, albumin, total protein.

Bioactive metabolites, Inflammatory markers Non-invasive serum markers of liver fibrosis and steatohepatitis. Hyaluronic acid, NAFLD fibrosis score, cytokeratine-18 fragments. Ultrasonography with non-invasive measurement of fibrosis and steatosis, magnetic resonance spectroscopy for visceral and liver fat determination.

Eligibility criteria: Inclusion Criteria:

* Patients with metabolic syndrome and NAFLD

Exclusion Criteria:

* Age below 18 years
* Gravidity
* Incompliance.

Primary outcomes:
measure: Number of patients with decreased liver fat content.
timeFrame: 12 months
Secondary outcomes:
measure: Number of patients with progression of liver fibrosis.
timeFrame: 12 months
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: General University Hospital
state: Prague 2
Study officials:
affiliation: General University Hospital, Prague
name: Radan Bruha, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Smid V, Dvorak K, Sedivy P, Kosek V, Lenicek M, Dezortova M, Hajslova J, Hajek M, Vitek L, Bechynska K, Bruha R. Effect of Omega-3 Polyunsaturated Fatty Acids on Lipid Metabolism in Patients With Metabolic Syndrome and NAFLD. Hepatol Commun. 2022 Jun;6(6):1336-1349. doi: 10.1002/hep4.1906. Epub 2022 Feb 11.
Clinical trial NCT05028894: 23andMe IPF Research Study
Official title: 23andMe Idiopathic Pulmonary Fibrosis Research Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Idiopathic Pulmonary Fibrosis
Keywords: idiopathic pulmonary fibrosis
IPF
pulmonary fibrosis
lung diseases
lung
respiratory tract diseases
rare
rare diseases
Hermansky-Pudlak syndrome
HPS
Lead sponsor: 23andMe, Inc.
Sponsor class: INDUSTRY
First posted: 2021-08-31
Enrollment: 690
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: The study population will only include participants who meet the eligibility criteria as described above. Participants in the study will be diagnosed with IPF or HPS.

Brief summary: The long term goal of this study is to increase genetic understanding of IPF to enable the development of an effective drug for IPF that can improve the lives of those living with the condition.

Detailed description: This study will recruit 1,000 people who have been diagnosed with IPF or Hermansky-Pudlak syndrome (HPS). Eligible participants who consent to participate in 23andMe Research and the IPF Research Study will receive a 23andMe Health + Ancestry kit at no cost. Participants will provide a saliva sample and take a baseline survey online answering questions about their disease diagnosis, testing, treatment, and symptoms. Participants will also be asked to take the same survey 3, 6, and 9 months after completing the baseline survey. The data collected from this study will be incorporated into the 23andMe Database and used to better understand the underlying genetic and environmental factors that contribute to IPF.

Eligibility criteria: Inclusion Criteria:

* Have been diagnosed with IPF or Hermansky-Pudlak syndrome (HPS)
* Are 18+ years old
* Live in the US

Exclusion Criteria:

- Have been diagnosed with sarcoidosis or hypersensitivity pneumonitis

Primary outcomes:
measure: IPF Symptom Progression Baseline
timeFrame: Baseline
measure: IPF Symptom Progression 3 month follow-up
timeFrame: 3 months post baseline
measure: IPF Symptom Progression 6 month follow-up
timeFrame: 6 months post baseline
measure: IPF Symptom Progression 9 month follow-up
timeFrame: 9 months post baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Sunnyvale
country: United States
facility: 23andMe
state: California
Study officials:
affiliation: 23andMe, Inc.
name: Suyash Shringarpure
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04763694: Dynamic Change in Accommodation After Wearing Multifocal Soft Contact Lenses for Myopia Control
Official title: Dynamic Change in Accommodation After Wearing Multifocal Soft Contact Lenses for Myopia Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Accommodation
Lead sponsor: State University of New York College of Optometry
Sponsor class: OTHER
First posted: 2021-02-21
Enrollment: 10
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to report the changes in accommodation, aberrations, and myopia in patients wearing multifocal soft contact lens for various durations.

The study objectives are to:

1. Determine the effects of wearing multifocal soft contact lens on accommodation and aberrations over a 12-month period.
2. Determine the effect of wearing multifocal soft contact lens on myopia over a 12-month period.


Eligibility criteria: Inclusion Criteria:

* Age: 8-17 years
* Refractive error: Sphere ≤ -10.00D, Cylinder ≤ 1.00D
* Monocular BCVA 20/25 or better
* No previous CL experience required

Exclusion Criteria:

* History of ocular pathology, binocular vision anomalies, refractive surgery, previous myopia control therapy, pharmaceutical agent known to affect accommodation.

Primary outcomes:
measure: Axial length
timeFrame: 12 months
measure: Refractive error
timeFrame: 12 months
measure: Accommodation
timeFrame: 12 months
Secondary outcomes:
measure: Phoria
timeFrame: 12 months
Other outcomes:
Locations:
city: New York
country: United States
facility: State University of New York
state: New York
Study officials:
affiliation: State University of New York College of Optometry
name: Stewart Bloomfield, PhD
role: STUDY_DIRECTOR
References: