louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01485146: A Multiple Ascending Dose Study of ETC-1002 in Healthy Subjects
Official title: A Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ETC-1002 at Doses Above 120 mg/Day in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Safety Evaluation of Escalating Doses
Lead sponsor: Esperion Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2011-12-05
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This Phase 1, double-blind (sponsor open), placebo controlled study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses of ETC-1002 in healthy subjects.


Eligibility criteria: Major Inclusion Criteria:

* Healthy male and female subjects of non-child bearing potential as determined by medical history, physical exam and vial sign measurements
* Body Mass Index of 18-32 kg/m2 inclusive with body weight \>50 kg

Major Exclusion Criteria:

* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>1.2 x Upper Limit of Normal(ULN), serum creatinine \>ULN, Hemoglobin \<12.0 g/dL
* Clinically significant disease that requires a physician's care and/or would interfere with study evaluations
* History of drug or alcohol abuse, consumption of alcohol within 48 hours prior to randomization, or a positive test for alcohol or drugs with a high potential for abuse prior to randomization
* Use of any prescription or nonprescription drugs, vitamins, or dietary supplements within 14 days prior to randomization
* Other exclusion criteria apply

Primary outcomes:
measure: Measuring subject safety by collecting and evaluating vital signs, adverse events, and laboratory measures.
timeFrame: 14 days
Secondary outcomes:
measure: Measuring the level of ETC-1002 and its metabolite ESP15228 in the blood.
timeFrame: 14 days
Other outcomes:
Locations:
city: Kalamazoo
country: United States
facility: Jasper Clinic, Inc.
state: Michigan
Study officials:
affiliation: Esperion Therapeutics, Inc.
name: Narendra Lalwani, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04864769: Effect of Intake of Hydrolyzed Krill Protein Isolate on Plasma Amino Acid Profile
Official title: Effect of Intake of Hydrolyzed Krill Protein Isolate, Whey Protein Isolate and Soy Protein Isolate on Plasma Amino Acid Profile
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Nutrition
Keywords: Protein
Amino Acids
Krill
Whey
Soy
Satiety
Insulin
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aker BioMarine Human Ingredients AS
First posted: 2021-04-29
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Design and Method: Randomized, controlled, double-blind cross-study, in which 12 healthy adult young men in randomized order ingest 35 g of protein of crude protein from one of the three protein sources or water on four different experimental days. Before and up to three hours after ingestion of the test beverage, blood samples are collected for 8 time points during each experimental day.
Primary purpose: BASIC_SCIENCE

Brief summary: Purpose: To examine the absorption of three different protein sources: hydrolyzed krill protein isolate, whey protein isolate, and soy protein isolate.

Detailed description: Design and Method: Randomized, controlled, double-blind cross-study, in which 12 healthy adult young men in randomized order ingest 35 g of protein of crude protein from one of the three protein sources or water on four different experimental days. Before and up to three hours after ingestion of the test beverage, blood samples are collected for 8 time points during each experimental day.

Eligibility criteria: Inclusion Criteria:

* men
* 18-30 years

Exclusion Criteria:

* smoking,
* medication,
* health issues conflicting with the experimental trial

Primary outcomes:
measure: Amino acids concentrations
timeFrame: 10 minutes prior to supplement up to 180 minutes after supplement
Secondary outcomes:
measure: Visual Analogue Scale (VAS)
timeFrame: 10 minutes prior to supplement up to 180 minutes after supplement
measure: Insulin
timeFrame: 10 minutes prior to supplement up to 180 minutes after supplement
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University, Department for Public Health, Section for Sport Science
Study officials:
References:
Clinical trial NCT04317469: Evaluation of Von Willebrand Factor as a Marker For Early Diagnosis of Acute Respiratory Distress Syndrome (A.R.D.S) in Comparison to Interleukin 6 [IL-6]
Official title: Evaluation of Von Willebrand Factor as a Marker For Early Diagnosis of Acute Respiratory Distress Syndrome (A.R.D.S) in Comparison to Interleukin 6 [IL-6]
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: ARDS, Human
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2020-03-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 60 patients, admitted to the ICUs, staying \>24 hrs will be randomly assigned to enter this study.

Brief summary: In this prospective study of 60patients, we tested the hypothesis That markedly elevated levels of plasma von Willebrand factor (VWF) a marker of endothelial cell injury might predict the development of acute respiratory distress syndrome (A.R.D.S) in risky patients. We compared our result to IL.6 as control biomarker for A.R.D.S development.

Acute lung injury was quantified on two -point scoring system (Berlin definition of ARDS and Murray score of acute lung injury).

Plasma levels of both vWF and IL.6 were be measured on T=0 i.e. (at start of the study once the patient considered to be risky for A.R.D.S development to obtain their baseline levels), T=48 (after 48 hours), and T=72 (after 72 hours).


Eligibility criteria: Inclusion Criteria:

* Patients between 18 and 80 years old of both sexes.
* risk factor for development of acute respiratory distress syndrome or acute lung injury either by:
* Direct lung injury includes: Severe pneumonia (infection), Breathing a vomited stomach contents (aspiration), Breathing harmful fumes or smoke, severe trauma to the chest or other accident that bruises the lungs.
* Indirect lung injury includes: sepsis, Severe injury or trauma with shock, blood transfusions , drug overdose acute pancreatitis, fracture of the long bones, near drowning ,anaphylaxis, uremia, fat embolus , and intracranial insult.

Exclusion Criteria:

* (1) pregnancy;
* (2) a preexisting medical condition with a life expectancy less than 3 months
* (3) evidence of cardiogenic pulmonary edema
* (4) age under 18 years old or above 80 years old
* (5) late stages of liver cell failure, renal failure
* (6) severe myocardial infarction
* (7) deep coma.

Primary outcomes:
measure: level of vwf at 72 hours
timeFrame: 72 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00044369: Role of the Toxic Metal Cadmium in the Mechanism Producing Infertility With a Varicocele
Official title: Increased Testicular Cd2+ & Infertility With Varicocele ( a Varicose Vein in the Scrotum)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Varicocele
Male Infertility
Hypospermatogenesis
Non-Obstructive Azoospermia
Keywords: Varicocele
environmental toxins
male infertility
cadmium
Lead sponsor: National Institute of Environmental Health Sciences (NIEHS)
Sponsor class: NIH
First posted: 2002-08-28
Enrollment: 400
Sex: MALE
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: Varicose veins in the scrotum (varicocele) are responsible for \>20% of male infertility in the US. Varicocele are associated with decreased sperm number and markedly reduced sperm fertilizing ability. Surgical repair or removal of varicocele restores fertility in only 1/3 of cases. The goal of this study is to identify markers that predict the outcome of variocele correction. This would offer considerable health cost savings.

Based on preliminary findings, we will obtain testis biopsies and semen specimens from infertile men with varicocele and prospectively examining the levels of cadmium, a toxic metal, and expression of genes required for normal sperm function. The semen and biopsies will be obtained during clinically dictated procedures. Cadmium and gene expression will be compared with response to varicocele repair (i.e., increased sperm production; pregnancy).


Eligibility criteria: * Healthy male with varicocele (grades 2 \[palpable\] or 3 \[visible, palpable\]) and no other diagnosed cause for infertility
* Non-smoker
* Actively desiring children but never having initiated a pregnancy
* Female partner having no unresolved fertility issues

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Camden
country: United States
facility: University of Medicine and Dentistry of NJ, Robert Wood Johnson Medical School at Camden
state: New Jersey
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
Study officials:
affiliation: North Shore University Hospital
name: Susan H Benoff, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Benoff S, Gilbert BR. Varicocele and male infertility: part I. Preface. Hum Reprod Update. 2001 Jan-Feb;7(1):47-54. doi: 10.1093/humupd/7.1.47. No abstract available.
citation: Benoff S, Hurley IR, Barcia M, Mandel FS, Cooper GW, Hershlag A. A potential role for cadmium in the etiology of varicocele-associated infertility. Fertil Steril. 1997 Feb;67(2):336-47. doi: 10.1016/S0015-0282(97)81921-8.
citation: Benoff S, Cooper GW, Centola GM, Jacob A, Hershlag A, Hurley IR. Metal ions and human sperm mannose receptors. Andrologia. 2000 Sep;32(4-5):317-29. doi: 10.1046/j.1439-0272.2000.00401.x.
citation: Benoff S, Jacob A, Hurley IR. Male infertility and environmental exposure to lead and cadmium. Hum Reprod Update. 2000 Mar-Apr;6(2):107-21. doi: 10.1093/humupd/6.2.107.
Clinical trial NCT02479269: The Influence of Aerobic Exercise on Serum Brain Natriuretic Peptide and C- Reactive Protein in Cardiovascular Disease
Official title: The Influence of Aerobic Exercise on Serum Brain Natriuretic Peptide and C- Reactive Protein in Cardiovascular Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Disease
Keywords: Brain Natriuretic Peptide
aerobic execise
C- Reactive Protein
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Islamic Azad University, Shiraz
First posted: 2015-06-24
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study was to investigate the effects of 8 weeks of aerobic exercise on serum concentrations of Brain Natriuretic Peptide and C - reactive protein in patients with cardiovascular disease. Patients were divided randomly into two groups: control and experimental aerobic group. This study was done with two - stage blood sampling: at the beginning and at the end of the treatment phase. All subjects were requested to avoid any exercise at least 48 hours before blood sampling. To study Brain Natriuretic Peptide and C - reactive protein changes, 5 milliliters of blood were taken from patient's brachial vein. Blood samples for subsequent measurements were frozen immediately and transported to the Hormone Laboratory for serum separation. The experimental group did the aerobic exercise programs for 8 weeks for 3 sessions per week and the control group did not receive any training. After completion of training, the final blood samplings were performed. Exercise intensity according to the heart rate remained stable until the last week. Brain Natriuretic Peptide and C - reactive protein levels were measured by ELISA tests. All statistical analysis were done using SPSS software (version 16) and at the significance level of p≤ 0.05


Eligibility criteria: Inclusion Criteria:

* In this trial patients with coronary artery disease more than 70 percent at least in one coronary vessel with Ejection Fraction more than 40 percent in recent Echo cardiograph without acute evidence of ischemia or congestive heart failure symptoms were selected and are divide randomly into two groups.

Exclusion Criteria:

* Patients with acute evidence of ischemia or congestive heart failure symptoms are excluded.

Primary outcomes:
measure: Brain Natriuretic Peptide
timeFrame: 8 weeks
measure: serum C - reactive protein
timeFrame: 8 weeks
Secondary outcomes:
measure: serum lipoproteins
timeFrame: 8 weeks
measure: Body Mass Index
timeFrame: 8 weeks
measure: blood pressure
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Shiraz University of Medical Sciences
name: Dr Mohammad Ali Ostovan, Cardiologist
role: STUDY_DIRECTOR
References:
Clinical trial NCT05126069: Ab Interno Gelatin Microstent With MMC vs. Trabeculectomy With MMC: 3 Year Retrospective Cohort Analysis
Official title: Longitudinal Gelatin Stent vs. Trabeculectomy (LongGVT Study): Ab Interno Gelatin Stent With Mitomycin C Versus Trabeculectomy With Mitomycin C: a Retrospective Cohort Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Filtering Surgery
Trabeculectomy
Keywords: Xen
Ab Interno Gelatin Microstent
Lead sponsor: Prism Eye Institute
Sponsor class: OTHER
First posted: 2021-11-18
Enrollment: 242
Sex: ALL
Minimum age (years): 30
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Glaucoma patients who received received a gelatin stent 45 with MMC (mitomycin C) or a trabeculectomy with MMC

Brief summary: To compare 3-year post-operative efficacy and safety of standalone ab interno gelatin microstent (Xen45®) versus trabeculectomy.

Detailed description: This is a single-center retrospective cohort study. Patients included were consecutive patients from June 2012 - July 2017 who received standalone Xen45® or standalone trabeculectomy. The primary outcome was time to failure, defined as intraocular pressure (IOP) outside of 6mmHg - 17mmHg on no medications on two consecutive visits despite in-clinic maneuvers (including needling). Secondary outcomes included IOP cutoffs of 14mmHg and 21mmHg with and without medications, as well as interventions, complications, and reoperations.

Eligibility criteria: Inclusion Criteria:

* Patients aged 30-90
* primary or pigmentary/pseudoexfoliative open angle, primary closed angle, narrow angle or combined mechanism glaucoma
* IOP of 18-40 on maximum tolerated medical therapy
* received a gelatin stent 45 with MMC or a trabeculectomy with MMC at Prism Eye Institute from June 2012 to July 2018, and have at least 3 years of follow-up.

Exclusion Criteria:

* Other forms of glaucoma
* prior incisional glaucoma surgery
* CPC
* combined surgery (cataract, cornea, or retina)
* prior corneal graft (PKP, DALK, DSAEK, DMEK)

Primary outcomes:
measure: time to failure
timeFrame: up to 3 years
Secondary outcomes:
measure: included IOP cutoffs of 14mmHg and 21mmHg with and without medications, as well as interventions, complications, and reoperations
timeFrame: up to 3 years
Other outcomes:
Locations:
city: Oakville
country: Canada
facility: Prism Eye Institute
state: Ontario
Study officials:
References:
citation: J Liu, M Schlenker, I Ahmed. Long-Term Efficacy & Safety of Standalone Ab Interno Gelatin Microstent Implantation with MMC Vs. Trabeculectomy with MMC: 3 Year Follow-up. ASCRS Conference 2021.
Clinical trial NCT05509569: A Survey of Icatibant in Pediatric Participants with Hereditary Angioedema
Official title: Specified Drug Use Surveillance of FIRAZYR Subcutaneous Injection 30mg Syringe for Pediatric Subjects with Hereditary Angioedema (All-Case Investigation)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Hereditary Angioedema (HAE)
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2022-08-22
Enrollment: 32
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The population of this survey are all participants who meet the inclusion/exclusion criteria.

Brief summary: This study is a survey in Japan of Icatibant subcutaneous injection 30 mg syringe used to treat children or teenagers with acute attacks of hereditary angioedema (HAE). The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study.

The main aim of the study is to check for side effects related from Icatibant subcutaneous injection 30 mg syringe and to check if Icatibant subcutaneous injection 30 mg syringe improves acute attacks of HAE.

During the study, pediatric participants with HAE will take Icatibant subcutaneous injection 30mg syringe according to their clinic's standard practice. The study doctors will check for side effects from Icatibant subcutaneous injection 30 mg syringe for 3 months.


Eligibility criteria: Inclusion Criteria:

- All participants with HAE who are 2 to \<18 years of age, treated with Icatibant subcutaneous injection 30 mg syringe for the first time.

Exclusion Criteria:

- Participants who have been treated with Icatibant subcutaneous injection 30 mg syringe in clinical trials or transfer cases, and so on.

Primary outcomes:
measure: Number of Participants who Experience at Least One Treatment-Emergent Adverse Events (TEAE)
timeFrame: Up to 3 Months
Secondary outcomes:
measure: Time from Onset of Seizure to Start of Treatment
timeFrame: Up to 3 Months
measure: Time from First Drug Administration to Symptom Resolution
timeFrame: Up to 3 Months
measure: Duration of Seizure
timeFrame: Up to 3 Months
Other outcomes:
Locations:
city: Tokyo
country: Jordan
facility: Takeda selected site
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00482469: The DIEP-Flap as a Model of Ischemia-Reperfusion
Official title: The DIEP-Flap as a Model of Ischemia-Reperfusion
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemia-Reperfusion
Keywords: ischemia-reperfusion
ischemia
reperfusion
DIEP-flap
flap
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2007-06-05
Enrollment: 45
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Clinical patients hospitalized for surgery.

Brief summary: It is our goal to study the mechanism of ischemia-reperfusion injury. Our DIEP-operation is actually a clinical model of ischemia-reperfusion. Ischemia-reperfusion injury has never been directly studied in a human, clinical model of autologous transplant.


Eligibility criteria: Inclusion Criteria:

* patient is undergoing a DIEP-breast reconstruction, unilateral as well as bilateral
* is aged 18 years or older

Exclusion Criteria:

* diabetes mellitus
* diseases of the kidneys
* diseases of the liver
* patients who are taking immunosuppressants

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Department of Plastic and Reconstructive surgery, Maastricht University Hospital
Study officials:
affiliation: Maastricht University Hospital
name: René R Van der Hulst, MD, PhD
role: STUDY_CHAIR
affiliation: Maastricht University Hospital
name: Marieke GW Van den Heuvel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: van den Heuvel MG, Bast A, Haenen GR, Ambergen AW, Mermans JF, van der Hulst RR. The role of antioxidants in ischaemia-reperfusion in a human DIEP flap model. J Plast Reconstr Aesthet Surg. 2012 Dec;65(12):1706-11. doi: 10.1016/j.bjps.2012.06.010. Epub 2012 Jul 11.
citation: van den Heuvel MG, Mermans JF, Ambergen AW, van der Hulst RR. Perfusion of the deep inferior epigastric perforator flap measured by laser Doppler imager. Ann Plast Surg. 2011 Jun;66(6):648-53. doi: 10.1097/SAP.0b013e3181e37bc8.
Clinical trial NCT03065569: A Comparison of Epidural Techniques for Labour Analgesia
Official title: A Comparison of Epidural Techniques for Labour Analgesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labour Analgesia
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2017-02-28
Enrollment: 150
Sex: FEMALE
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A trial comparing outcomes for different epidural techniques in labour analgesia

Detailed description: Epidurals are the most common form of pain relief in labour. There are two techniques in use at the moment to place the epidural: epidural or combined spinal epidural (CSE). CSE has been shown to work faster and provide better pain relief than epidural alone. The investigators aim to show that CSE also requires less medication over the course of labour as this may mean it has fewer side effects. The amount of medication needed during labour between the two different techniques given in a standardized way will be compared.

Eligibility criteria: Inclusion Criteria:

* Healthy, singleton presentation at term

Exclusion Criteria:

* Significant comorbidities likely to alter outcome of labour

Primary outcomes:
measure: Bupivacaine requirement for analgesia
timeFrame: From randomization until delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: BC Women's Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: British Columbia's Women's Hospital
state: British Columbia
Study officials:
affiliation: UBC
name: Anton Chau, MD MMSc
role: PRINCIPAL_INVESTIGATOR
References: