louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01064674: Cardiovascular Evaluation Before Renal Transplantation
Official title: Cardiovascular Diagnostic Before Renal Transplantation: a Prospective Study to Assess Cardiovascular Morbidity Before Renal Transplantation and to Improve Standard Diagnostic Procedures.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Kidney Disease
Coronary Artery Disease
Keywords: renal transplantation
cardiovascular morbidity
evaluation before renal transplantation
Lead sponsor: University Hospital Muenster
Sponsor class: OTHER
First posted: 2010-02-08
Enrollment: 100
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: All patients with endstage renal disease which are awaiting their ergsitration to our transplantation programm since July 2009 until July 2010.

Brief summary: Due to rising importance of cardiovascular disease before and after renal transplantation we have changed our standard diagnostic procedure and perform stress echocardiography and myocardial scintigraphy. We would like to monitor these results and the outcome of our patients.

Detailed description: Chronic kidney disease is a well-known risk factor for cardiovascular disease. Patients waiting for a renal transplantation usually undergo an extensive diagnostic procedure to avoid complications after transplantation such as neoplasia or inflammation. In the past years, cardiovascular complications before and after renal transplantation have gained more attention. We therefore have changed our standard diagnostic procedure before renal transplantation and perform stress echocardiography and myocardial scintigraphy. Thus we would like to evaluate our new standard diagnostic procedure and observe the results of these diagnostic procedures as well as their impact on clinical outcome.

Eligibility criteria: Inclusion Criteria:

* endstage renal disease
* preparing for renal transplantation

Exclusion Criteria:

* children (\< 18 years)
* women who are pregnant or nursing
* patients who are also awaiting heart transplantation or have already a heart transplant
* severe mental illness

Primary outcomes:
measure: cardiovascular morbidity
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Muenster
country: Germany
facility: Department of Internal Medicine D, University Hospital Muenster
Study officials:
affiliation: University Hospital Muenster
name: Barbara Suwelack, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Muenster
name: Hermann Pavenstädt, MD
role: STUDY_CHAIR
affiliation: University Hospital Muenster
name: Holger Reinecke, MD
role: STUDY_CHAIR
affiliation: University Hospital Muenster
name: Otmar Schober, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05453474: Cell-based Non-invasive Prenatal Testing as an Alternative to Invasive Chorionic Villus Sampling
Official title: Cell-based Non-invasive Prenatal Testing - Evaluation of Time of Blood Sampling and Whole Genome Amplification Prior to Genetic Testing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hereditary Diseases
Keywords: cell-based non-invasive prenatal testing
Hereditary disorders
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
Collaborators: name: Arcedi Biotech
name: Aarhus University Hospital
First posted: 2022-07-12
Enrollment: 48
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All patients had either one or two blood samples collected. Each blood sampled had either all cells lyzed or cells were split between lysis and whole genome amplification. Hence, the study is considered to have to seperate analysis each with two arms.
Primary purpose: DIAGNOSTIC

Brief summary: The study aims to evaluate cell-based non-invasive prenatal testing (cbNIPT) as an alternative to invasive chorionic villus sampling (CVS) in patients who achieve pregnancy following preimplantation genetic testing for hereditary disorders.

Detailed description: The study has three main objects:

1. to evaluate the optimal time of blood sampling (gestational week 7-8 or 11-14)
2. to evaluate whole genome amplification prior to genetic analysis og isolated fetal cells (only relevant for monogenic disorders)
3. evaluating specificity and sensitivity

Eligibility criteria: Inclusion Criteria:

* Pregnancy following preimplantation genetic testing

Exclusion Criteria:

* None

Primary outcomes:
measure: Evaluation of the fetal cell yield when blood sampling is performed at Gestational weeks 7-8 compared to gestational weeks 11-14.
timeFrame: Within 2 years
measure: Percentage of test with an informative test result from genetic testing following whole genome amplification or direct testing without whole genome amplification.
timeFrame: Within 2 years (since data analysis is carried out later than sample collection)
measure: Specificity and sensitivity of single cell analysis.
timeFrame: Within 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Fertility Unit, Aalborg University Hospital
Study officials:
References:
citation: Toft CLF, Ingerslev HJ, Kesmodel US, Hatt L, Singh R, Ravn K, Nicolaisen BH, Christensen IB, Kolvraa M, Jeppesen LD, Schelde P, Vogel I, Uldbjerg N, Farlie R, Sommer S, Ostergard MLV, Jensen AN, Mogensen H, Kjartansdottir KR, Degn B, Okkels H, Ernst A, Pedersen IS. Cell-based non-invasive prenatal testing for monogenic disorders: confirmation of unaffected fetuses following preimplantation genetic testing. J Assist Reprod Genet. 2021 Aug;38(8):1959-1970. doi: 10.1007/s10815-021-02104-5. Epub 2021 Mar 7.
Clinical trial NCT03239574: MightySat - Clinical Performance Comparison Study
Official title: MightySat - Clinical Performance Comparison Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Conditions: Healthy
Lead sponsor: Masimo Corporation
Sponsor class: INDUSTRY
First posted: 2017-08-04
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study compares the performance of respiratory rate from pleth (RRp) measured with MightySat device on healthy subjects.Subjects will be asked to breathe at specific rates ranging from 5 to 30 breaths per minute.


Eligibility criteria: Inclusion Criteria:

* 18 to 45 years old
* Physical status of ASA I or II
* Must be able to read and communicate in English
* Has signed all necessary related documents, e.g. written informed consent, confidentiality agreement
* Passed health assessment screening
* Negative pregnancy test for female subjects of child bearing potential

Exclusion Criteria:

* Younger than 18 years old, older than 45 years old
* ASA physical status of III, IV, and V
* Subject has any medical condition which in the judgement of the investigator, renders them inappropriate for participation in the study
* Inability to tolerate sitting still or minimal movement for at least 30 minutes
* Positive pregnancy test for female subjects
* Refusal to take pregnancy test for women of child bearing potential
* Nursing female subjects
* Refusal of male subjects to agree to shave hair off areas where sensors will be applied (neck)
* Excluded at Principal Investigator's discretion

Primary outcomes:
measure: Accuracy of RRp Determination
timeFrame: approximately 30-40 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Masimo Clinical Lab
state: California
Study officials:
References:
Clinical trial NCT01637974: Efficiency of INTERCOAT (Oxiplex/AP Gel) in Preventing Intrauterine Adhesion Formation in Hysteroscopic Surgery
Official title: Efficiency of INTERCOAT (Oxiplex/AP Gel) in Preventing Intrauterine Adhesion Formation in Hysteroscopic Surgery - a Prospective Double Blind Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Asherman Syndrome
Endometrial Polyp
Uterine Myoma
Lead sponsor: Carmel Medical Center
Sponsor class: OTHER
First posted: 2012-07-11
Enrollment: 130
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study purpose is to examine the influence of INTERCOAT in prevention of intra-uterine adhesions formation after any hysteroscopic surgery.


Eligibility criteria: Inclusion Criteria:

* Age between 18 and 50 years
* Must be able to understand, read and sign consent form

Exclusion Criteria:

* Signs of infection upon admission
* Ongoing pregnancy
* Carcinoma of the uterus or cervix
* Recurrent PID
* Women admitted for endometrial ablation
* Women that gave birth 6 weeks ago
* Women participating in another study

Primary outcomes:
measure: Presence of intra-uterine adhesions in a follow up diagnostic hysteroscopy
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Carmel Medical Center
Study officials:
References:
Clinical trial NCT03134365: Palatability and Postprandial Sensations
Official title: Factors to Determine the Responses to Meal Ingestion: Palatability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: meal ingestion
palatability
postprandial responses
hedonic response
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
First posted: 2017-04-28
Enrollment: 22
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Aim: to determine the effect of palatability on the cognitive (satiation/fullness) and emotive (digestive well-being/mood) responses to meal ingestion. The postprandial responses to conventional (potato and cheese cream followed by vanilla cream) versus unconventional test meals (mixture of both creams) with identical composition (350 Kcal) and physical characteristics (colour, texture, consistency, temperature) but distinctively different palatability will be studied on a cross over-design. The responses to the meals will be tested on 2 different days.

Participants (22 non-obese healthy men) will be instructed to eat a standard dinner the day before, to consume a standard breakfast at home after overnight fast, and to report to the laboratory, where the test meal will be administered 5 h after breakfast. Studies will be conducted in a quiet, isolated room with participants sitting on a chair. Perception will be measured at 5 min intervals 10 min before and 20 min after ingestion and at 10 min intervals up to 60 min after the probe meal.


Eligibility criteria: Inclusion Criteria:

* non obese

Exclusion Criteria:

* history of gastrointestinal symptoms
* prior obesity
* use of medications
* history of anosmia and ageusia
* current dieting
* alcohol abuse
* psychological disorders
* eating disorders

Primary outcomes:
measure: Meal palatability
timeFrame: 1 day
measure: Change in digestive well-being measured after the test meal
timeFrame: 1 day
Secondary outcomes:
measure: Change in satiety measured after the test meal
timeFrame: 1 day
measure: Change in fullness sensation measured after the test meal
timeFrame: 1 day
measure: Change in abdominal discomfort/pain sensation measured after the test meal
timeFrame: 1 day
measure: Change in mood measured after the test meal
timeFrame: 1 day
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: University Hospital Vall d'Hebron
Study officials:
References:
Clinical trial NCT04050865: A Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Allergic Conjunctivitis
Official title: CLN-0052, A Multi-Center, Randomized, Double-Masked, Vehicle Controlled Phase 3 Study Evaluation the Efficacy and Safety of OTX-DP for the Treatment of Allergic Conjunctivitis Using a Modified Conjunctival Allergen Challenge Model (Ora-CAC®)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Allergic Conjunctivitis
Lead sponsor: Ocular Therapeutix, Inc.
Sponsor class: INDUSTRY
First posted: 2019-08-08
Enrollment: 96
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 objective of the study is to evaluate the efficacy and safety of OTX-DP as a dexamethasone ophthalmic insert when placed in the canaliculus of the eyelid for the treatment of the signs and symptoms of allergic conjunctivitis.


Eligibility criteria: Inclusion Criteria:

* Has a positive history of ocular allergies and a positive skin test reaction to a perennial allergen and a seasonal allergen
* Has a positive bilateral CAC reaction to a perennial allergen within minutes of instillation

Exclusion Criteria:

* History of refractive surgery (including LASIK procedures) within the past 2 years
* History of retinal detachment, diabetic retinopathy, or active retinal disease
* Presence of an active ocular infection or positive history of an ocular herpetic infection at any visit
* History of IOP increase as a result of steroid treatment
* A female who is currently pregnant, planning a pregnancy, or lactating

Primary outcomes:
measure: Ocular Itching Post-CAC (Conjunctival Allergen Challenge) at Visit 6 (7 Days Post-insertion)
timeFrame: 3 minutes
measure: Ocular Itching Post-CAC (Conjunctival Allergan Challenge) at Visit 6 (7 Days Post-insertion)
timeFrame: 5 minutes
measure: Ocular Itching Post-CAC (Conjunctival Allergan Challenge) at Visit 6 (7 Days Post-insertion)
timeFrame: 7 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Colorado Springs
country: United States
facility: Vision Institute
state: Colorado
city: Louisville
country: United States
facility: The Eye Care Institute
state: Kentucky
city: Raynham
country: United States
facility: Andover Eye Associates
state: Massachusetts
city: Kansas City
country: United States
facility: Silverstein Eye Centers
state: Missouri
city: Memphis
country: United States
facility: Total Eye Care, P.A.
state: Tennessee
city: Round Rock
country: United States
facility: Eye Associates of Texas
state: Texas
Study officials:
References:
Clinical trial NCT00566865: Drug-Drug Interaction Study of Mitiglinide and Gemfibrozil
Official title: A Double-Blind, Placebo-Controlled Study to Assess the Effect of Gemfibrozil Co-Administration on the Pharmacokinetics and Pharmacodynamics of Mitiglinide in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Elixir Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2007-12-04
Enrollment: 14
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 primary objective of this study is to determine the extent of effect of gemfibrozil on the pharmacokinetics and pharmacodynamics of mitiglinide.


Eligibility criteria: Inclusion Criteria:

* non-smoker
* Body mass index (BMI) of 19-28 kg/m2
* no relevant food allergies

Exclusion Criteria:

* any subject for whom gemfibrozil is contraindicated
* any subject with a history of hypoglycemia or who tend to get easily hypoglycemic
* clinically significant history of or current abnormality or disease of any organ system

Primary outcomes:
measure: pharmacokinetics of mitiglinide
timeFrame: 3 days of treatment with gemfibrozil
measure: pharmacodynamics of mitiglinide
timeFrame: 3 days of treatment with gemfibrozil
Secondary outcomes:
measure: safety and tolerance of mitiglinide when co-administered with 600 mg gemfibrozil
timeFrame: 3 days of treatment with gemfibrozil
Other outcomes:
Locations:
Study officials:
affiliation: Quintiles Phase I Services
name: Erin Nulf, RN, BSN
role: STUDY_DIRECTOR
References:
Clinical trial NCT02356965: Study Testing Ketamine Sublingual Wafer After Wisdom Tooth Extraction
Official title: A Randomized, Double-Blind, Parallel Group, Placebo-Controlled, Dose Ranging Study to Assess the Analgesic Efficacy, Tolerability, Safety and Pharmacokinetic/Pharmacodynamic Properties of A Sublingual Wafer Formulation of Ketamine Following Third Molar Extraction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain
Keywords: Third molar extraction
Wisdom tooth extraction
Lead sponsor: iX Biopharma Ltd.
Sponsor class: OTHER
Collaborators: name: Jean Brown Research
name: Lotus Clinical Research, LLC
First posted: 2015-02-06
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to test two different doses of ketamine sub-lingual (under the tongue) wafer against placebo to see how effective the medication is to treat moderate to severe pain after wisdom tooth extraction.

Detailed description: This is a Phase 2, randomized, double-blind, parallel group, dose-ranging placebo-controlled evaluation of the analgesic efficacy, safety and pharmacokinetics of ketamine sublingual wafer in adult subjects who experience post-operative pain after undergoing third molar extraction.

The study will enroll approximately 80 subjects at a single site. Subjects will be at least 18 years to 38 years of age. Subjects will receive a single dose of 70 mg or 100 mg sublingual ketamine wafer or placebo.

Efficacy assessment will include pain intensity, use of rescue medication, and Patient Global Assessment (PGA) of pain control. Safety assessments will include monitoring of AEs and SAEs, clinical laboratory tests, vital sign measurements, oral assessments, and ECGs.

A maximum of eight 4ml blood samples will be taken from each participant up to 8 hours after study drug administration for plasma analysis.

Eligibility criteria: Healthy male and female subjects, ages 18-38 years old, who are scheduled to undergo two ipsilateral third molar extractions.

Primary outcomes:
measure: Sum of Pain Intensity Difference
timeFrame: 3 hours
Secondary outcomes:
measure: Sum of Pain Intensity Difference
timeFrame: 6 hours
measure: Safety and Tolerability evaluated by physical examination, vital signs, pulse oximetry, clinical laboratory tests, ECGs and Incident of Adverse Events (AEs) and Serious Adverse Events (SAEs).
timeFrame: 8 hours
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Jean Brown Research
state: Utah
Study officials:
affiliation: Jean Brown Research
name: Derek D Muse, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04607265: Sudden Death Stratification
Official title: Channel Detection to Predict Ventricular Arrhythmia in Patients With Non-ischemic Cardiomyopathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-ischemic Cardiomyopathy
Keywords: LGE MRI
Ventricular tachycardia
sudden cardiac death
non-ischemic cardiomyopathy
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2020-10-29
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients that underwent VT ablation, had a cardiac MRI prior to the ablation and suffered from non-ischemic cardiomyopathy (NICM) were included in the VT group. A 2:1 ratio of patients with non-ischemic cardiomyopathy and no history of ventricular tachycardia were included in the control group.

Brief summary: Sudden cardiac death (SCD) risk stratification is a challenge in non-ischemic cardiomyopathy (NICM). The underlying mechanism of monomorphic ventricular tachycardia (VT) is mostly scar related. While electrophysiological mechanisms underlying ventricular arrhythmia are well known, late gadolinium enhanced (LGE) cardiac MRI-3D reconstructions are now able to guide VT ablation procedures. Such exam may help in identifying specific properties of scar at risk of malignant arrhythmia.


Eligibility criteria: Inclusion Criteria:

* Adult with NICM
* Previous history of ventricular tachycardia (VT) and no previous history of VT

Exclusion Criteria:

* Inherited cardiomyopathies
* Previous history of myocarditis WITHOUT oedema/scar at the MRI

Primary outcomes:
measure: Detect pro arrhythmogenic scar characteristics
timeFrame: baseline : collected at the time of the cardiac MRI
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01001065: Association of the Intrarenal Resistance Index (RI) of Transplanted Kidneys With Generalized Atherosclerosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Renal Transplantation
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2009-10-23
Enrollment: 160
Sex: ALL
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: Patients after renal transplantation with stable renal function

Brief summary: Cross sectional observational ultrasound study of transplanted kidneys and the carotid artery in consecutive recruited outpatients.


Eligibility criteria: Inclusion criteria:

* Patients after renal transplantation with stable renal function

Exclusion criteria:

* Known impairment of renal function (e.g. acute rejection)
* Known renal artery or carotid artery stenosis

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
Study officials:
affiliation: UniversitaetsSpital Zuerich
name: 01 Studienregister MasterAdmins
role: STUDY_DIRECTOR
References:
Clinical trial NCT01381965: Foveal Cone Outer Segment Resumption to Predict Visual Recovery After Macular Hole Surgery
Official title: Foveal Cone Outer Segment Resumption to Predict Visual Recovery After Macular Hole Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Macular Holes
Keywords: spectral-domain optical coherence tomography
idiopathic macular hole
cone outer segment tips line
vitrectomy
Lead sponsor: Kyorin University
Sponsor class: OTHER
First posted: 2011-06-27
Enrollment: 72
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Spectral domain optical coherence tomography (SD-OCT) was used to determine whether the repair of photoreceptor cone outer segment tips defect is significantly correlated with the visual outcomes after macular hole surgery.

Detailed description: Spectral domain optical coherence tomography (SD-OCT) was used to calculate the mean length of photoreceptor cone outer segment tips (COST) defect on 1, 3, 6, 9, and 12 months after macular hole surgery. The correlation between the mean length of COST defect and the BCVA was determined. Prognostic factors might have influenced for COST repair was also evaluated by multivariable analysis.

Eligibility criteria: Inclusion Criteria:

* macular hole patients with surgically-closed hole

Exclusion Criteria:

* macular hole patients failed to close hole
* presence of retinal diseases including a treated rhegmatogenous retinal detachment, diabetic retinopathy, and high myopia with an axial length \>27.0mm or refractive error \> -8.0 diopters(D).
* patients who were not followed at least 6 months

Primary outcomes:
measure: Visual acuity
timeFrame: one year
Secondary outcomes:
measure: Integrity of cone outer segment tips line
timeFrame: one year
Other outcomes:
Locations:
city: Mitaka
country: Japan
facility: Makoto Inoue
state: Tokyo
Study officials:
affiliation: Kyorin Eye Center
name: Makoto Inoue, MD
role: PRINCIPAL_INVESTIGATOR
References: