louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04962477: Understanding Host-pathogen Interaction in the Respiratory Mucosa During Pregnancy
Official title: Understanding Host-pathogen Interaction in the Respiratory Mucosa During Pregnancy
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Pregnancy Related
Innate Inflammatory Response
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2021-07-15
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant cohort: pregnant women in their third trimester admitted to the hospital for any elective procedure (cesarean delivery, labor induction etc.,)

Non-pregnant cohort: age-matched female volunteers

Brief summary: The clinical presentation of the ongoing coronavirus disease-19 (COVID-19) pandemic in pregnant women is unique with more asymptomatic infection, higher morbidity when symptomatic, yet without a difference in mortality rate. This is strikingly different from the high mortality observed during the past influenza A pandemics. Though both influenza A virus (IAV) and SARS-CoV-2 are single-stranded RNA viruses, the exquisite vulnerability of pregnant women to influenza A but not COVID-19 remains a mystery. Our objective, therefore, is to determine the mechanisms that predispose pregnant women to severe influenza A but confer protection against SARS-CoV-2 infection by examining the viral entry factors and innate immune response mechanisms in the nasal epithelium of pregnant vs. non-pregnant age-matched women.


Eligibility criteria: Inclusion Criteria:

* Healthy, uncomplicated pregnant subjects in the third trimester ((≥ 28 ≤ 41 weeks' gestation)
* Healthy non-pregnant adult female volunteers between the ages of 18 - 45 years.
* Between 18-45 years old
* Able to provide consent

Exclusion Criteria:

* Patients in labor
* Critically ill patients needing intubation and mechanical ventilation
* Patients with fever or influenza-like illness
* H/o epistaxis or rhinosinusitis
* Nasal polyposis and deviated nasal septum
* Preeclampsia and chronic hypertension
* Use of anti-hypertensives
* Ongoing seasonal allergy
* H/o asthma
* Recent recovery from SARS-CoV-2 or influenza A infection (≤ 4 weeks)
* Recent receipt of either COVID-19 or influenza A vaccine (≤ 4 weeks)
* Use of immunosuppressive medications
* Use of inhaled corticosteroids
* Use of hormonal contraceptives in non-pregnant population
* Allergy to local anesthetic

Primary outcomes:
measure: Expression of viral entry factors
timeFrame: Dec 2021
Secondary outcomes:
measure: Expression of genes involved in innate immune response and host-pathogen interaction
timeFrame: Dec 2021
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Arvind Palanisamy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03726177: Aspirin for Prevention of Preeclampsia
Official title: Comparison of Two Doses (81 mg Versus 162mg) of Aspirin for the Prevention of Preeclampsia in High-Risk Pregnant Women: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Preeclampsia
Keywords: preeclampsia
low dose aspirin
high risk pregnancy
Lead sponsor: Aswan University Hospital
Sponsor class: OTHER
First posted: 2018-10-31
Enrollment: 600
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This will be a randomized control trial to estimate the efficacy of two doses (80 mg versus 160 mg) of aspirin for prevention of preeclampsia in High-Risk Pregnant Women identified in the first trimester to be at high risk.
Primary purpose: PREVENTION

Brief summary: Prophylaxis with low-dose aspirin has been recommended to prevent preeclampsia, the rationale being that hypertension and abnormalities of coagulation in this disease are caused in part by an imbalance between vasodilating and vasoconstricting prostaglandins. Low-dose aspirin therapy inhibits thromboxane production more than prostacyclin production and therefore should protect against vasoconstriction and pathologic blood coagulation in the placenta. Initially, several single-center trials, mostly among women at increased risk for preeclampsia, demonstrated a substantial reduction in the risk of proteinuric hypertension as well as reductions in the incidences of preterm birth, infants small for gestational age, and perinatal death,

Detailed description: This will be a randomized control trial to estimate the efficacy of two doses (80 mg versus 160 mg) of aspirin for prevention of preeclampsia in High-Risk Pregnant Women identified in the first trimester to be at high risk.

Eligibility criteria: Inclusion Criteria:

* Pregnant women presenting prior to 17+0 weeks' gestation.
* Moderate to high risk of preeclampsia.
* One or more of the following: previous history of preeclampsia, antiphospholipid antibodies, pre-existing diabetes, pre-existing hypertension, pre-existing renal disease, autoimmune disease, nulliparity, family history of preeclampsia, elevated BMI \> 25, and maternal age \<20 or \>35.
* Give written informed consent.

Exclusion Criteria:

* Multiple gestations,
* fetal aneuploidy
* major fetal structural anomaly
* bleeding disorder
* allergy to aspirin
* women already on aspirin or heparin.

Primary outcomes:
measure: Number of Participants With early Preeclampsia
timeFrame: 6 months
Secondary outcomes:
measure: Prevention of preeclampsia between 37 and 41
timeFrame: 6 months
measure: The number of cases of Fetal Growth Restriction
timeFrame: 6 months
measure: The number of cases of preterm birth
timeFrame: 6 months
Other outcomes:
Locations:
city: Aswan
country: Egypt
facility: Aswan University
Study officials:
affiliation: Aswan University Hospital
name: hany f sallam, md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06031077: Effectiveness and Safety of Distal Left Transradial Access in Coronary Procedures.
Official title: Effectiveness and Safety of Distal Left Transradial Access in Coronary Procedures.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Cardiomyopathies
Keywords: Distal Radial Artery Angiogram
Anatomical Snuff Box Angiogram
Lead sponsor: The University of The West Indies
Sponsor class: OTHER
First posted: 2023-09-11
Enrollment: 150
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Caribbean decent population of Trinidad and Tobago.

Brief summary: To evaluate the effectiveness and safety of distal left radial (dLR) access in coronary procedures at a tertiary center in Trinidad and Tobago.

Detailed description: An observational, retrospective study will be carried out. Roughly 111 patients were registered at EWMSC and Cardiac Angiograms were done via approached through the left radial access between January 2020 and June 2021 at EWMSC. However since 2021 Cardiac Angiograms were also done via the anatomical snuff box. This study seeks to compare the results of Cardiac Angiograms vs Left Radial Access and the Anatomical Snuff box.

Eligibility criteria: Cardiologist recommended guidelines.

Primary outcomes:
measure: Comparison of snuff box access to radial access for coronary angiography in Trinidad and Tobago.
timeFrame: roughly 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Port Of Spain
country: Trinidad and Tobago
facility: Eric Williams Medical Sciences Complex
state: North Central
Study officials:
References:
Clinical trial NCT00706277: Effect of Total Intravenous Anesthesia and Balanced Anesthesia on Postoperative Lung Function
Official title: Effect of Total Intravenous Anesthesia and Balanced Anesthesia on Postoperative Lung Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Lung Function
Keywords: forced vital capacity
forced expired volume in 1 s
Lead sponsor: Medical University Innsbruck
Sponsor class: OTHER
First posted: 2008-06-27
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the study is to investigate the effects of total intravenous anesthesia (TIVA; propofol, remifentanil) and balanced anesthesia (BAL; induction with propofol and fentanyl; maintenance of anesthesia with sevoflurane and nitrous oxide) on pulmonary function 30 minutes after emergence from the general anesthesia.


Eligibility criteria: Inclusion Criteria:

* ASA 1-2
* BMI normal

Exclusion Criteria:

* lung disease
* Nicotine abuse

Primary outcomes:
measure: FEV1 forced expiratory volume; FVC forced vital capacity
timeFrame: preoperative, 30 minutes postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: TILAK Hospitals
Study officials:
affiliation: TILAK Hospitals
name: Arnulf Benzer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gunnarsson L, Lindberg P, Tokics L, Thorstensson O, Thorne A. Lung function after open versus laparoscopic cholecystectomy. Acta Anaesthesiol Scand. 1995 Apr;39(3):302-6. doi: 10.1111/j.1399-6576.1995.tb04066.x.
citation: Regli A, von Ungern-Sternberg BS, Reber A, Schneider MC. Impact of spinal anaesthesia on peri-operative lung volumes in obese and morbidly obese female patients. Anaesthesia. 2006 Mar;61(3):215-21. doi: 10.1111/j.1365-2044.2005.04441.x.
citation: Natalini G, Franceschetti ME, Pletti C, Recupero D, Lanza G, Bernardini A. Impact of laryngeal mask airway and tracheal tube on pulmonary function during the early postoperative period. Acta Anaesthesiol Scand. 2002 May;46(5):525-8. doi: 10.1034/j.1399-6576.2002.460509.x.
Clinical trial NCT01997177: Assessment of Competence in Colonoscopy Using Motion Capture
Official title: Assessment of Competence in Colonoscopy Using Motion Capture
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sensitivity Training Groups
Keywords: simulation
training
colonoscopy
standard setting
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2013-11-27
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Doctors in gastroenterology

Brief summary: Aim: To study the basic technical skills of colonoscopy using a MS Kinect for motion analysis. In order to develop a non-biased tool to monitor competence.

Detailed description: To compare a group of novices to a group of experienced endoscopists performining colonoscopy.

Analyzing the motion pattern of the performers using a Kinect. Use the contrasting group method to set standards.

Eligibility criteria: Inclusion Criteria: none experience in colonoscopy or experience more than 350 colonoscopy procedures -

Exclusion Criteria: none

-

Primary outcomes:
measure: to identify metrics of importans in colonoscopy training program
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: CEKU, Centre of Clinical education
Study officials:
affiliation: CEKU, Centre of clinical education, University of Copenhagen
name: Louise Preisler, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Preisler L, Sondergaard Svendsen MB, Sondergaard B, Brink L, Nordentoft T, Svendsen LB, Konge L. Automatic and unbiased assessment of competence in colonoscopy: exploring validity of the Colonoscopy Progression Score (CoPS). Endosc Int Open. 2016 Dec;4(12):E1238-E1243. doi: 10.1055/s-0042-118226. Epub 2016 Nov 17.
Clinical trial NCT06647277: Fecal MicrobiotaTransplant for the Treatment of Parkinson's Disease
Official title: An Open-Label Phase I Clinical Trial of Vancomycin Followed by Fecal Microbiota Transplant for the Treatment of Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Parkinson Disease
Lead sponsor: ProgenaBiome
Sponsor class: OTHER
First posted: 2024-10-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: FMT may significantly improve quality of life and Parkinson Disease (PD) symptom severity measurements. We hypothesize that gut microbial dysbiosis is a major contributing factor in Parkinson's disease.

Detailed description: This is an open-label clinical trial to evaluate the Safety of fecal microbiota transplant following a 10 day treatment with Vancomycin in adult subjects with Parkinson's disease. Subjects in the study are required to meet with the study clinician on 11 occasions: two (2) visits for informed consent and baseline assessment, one (1) visit prior to FMT for colonoscopy instructions and exam, one (1) visit for the fecal microbiota transplant procedure by colonoscopy at an outpatient surgical center, seven (7) visits for post-FMT assessment. There are also daily phone calls in the week following the FMT, and weekly phone call visits (during weeks in which there is not a physical visit) to check up on how the subject is doing, any change in medications, side effects, and answer any questions.

Eligibility criteria: Inclusion Criteria:

* Individuals diagnosed with PD

Exclusion Criteria:

* Non-PD individuals

Primary outcomes:
measure: Parkinson's disease symptoms
timeFrame: 6.5 months for each subject
Secondary outcomes:
measure: Alterations in Subject microbiome from baseline
timeFrame: 6.5 months for each subject
Other outcomes:
Locations:
city: Ventura
country: United States
facility: Sabine Hazan
state: California
Study officials:
References:
Clinical trial NCT04390477: Study to Evaluate the Effect of a Probiotic in COVID-19
Official title: The Intestinal Microbiota as a Therapeutic Target in Hospitalized Patients With COVID-19 Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Coronavirus Infection
Keywords: Probiotic
Lead sponsor: Bioithas SL
Sponsor class: INDUSTRY
First posted: 2020-05-15
Enrollment: 41
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: A prospective case-control pilot study to evaluate the possible effect of a probiotic mixture in the improvement of symptoms, the reduction in the number of days of hospitalization and the increase in the percentage of patients with negative PCR after infection with the coronavirus SARS-CoV-2.

Detailed description: In this study, the investigators hypothesize a positive effect of probiotic on the gut microbiome that could led to produce a less severe clinical evolution of the disease.

Eligibility criteria: Inclusion Criteria:

* Patients with a confirmed diagnosis of SARS-Cov.2 infection using the PCR and that require admission to the hospitalization area.

Exclusion Criteria:

* Inability or refusal to sign informed consent.
* Allergy or intolerance to the intervention product or its components.

Primary outcomes:
measure: Cases with discharge to ICU.
timeFrame: 30-days
measure: Patients with resolution of digestive symptoms
timeFrame: 30 days
Secondary outcomes:
measure: Patients with home discharge.
timeFrame: 30-days
measure: Mortality.
timeFrame: 30-days
measure: Treatment safety assessed by number of adverse events.
timeFrame: 30-days
measure: New cases of SARS-Cov-2 infection among healthcare personnel caring for the patients.
timeFrame: 30-days
measure: Patients with negative PCR and/or Antigen test result for SARS-CoV-2 infection.
timeFrame: 10-15 days
measure: Patients with resolution of non-digestive symptoms
timeFrame: 30 days
Other outcomes:
Locations:
city: Elche
country: Spain
facility: Hospital Universitario del Vinalopó
state: Alicante
city: Torrevieja
country: Spain
facility: Hospital Universitario de Torrevieja
state: Alicante
Study officials:
affiliation: Hospital universitario del Vinalopo, Elche, Spain
name: Vicente Navarro
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00911677: Does APOE-e4 Predict Delirium and Cognitive Dysfunction After Surgery?
Official title: Does Apolipoprotein E Genotype Predict Delirium and Postoperative Cognitive Dysfunction?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Delirium
Postoperative Cognitive Dysfunction
Keywords: Delirium (MeSH Unique ID D003693)
Cognition Disorders (MeSH Unique ID D003072)
Postoperative Complications (MeSH Unique ID D011183)
Apolipoproteins E (MeSH Unique ID D001057)
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: Canadian Anesthesiologists' Society
name: University of Ottawa
First posted: 2009-06-02
Enrollment: 100
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: Patients 60 years of age or greater undergoing open repair of the abdominal aorta at an academic tertiary care hospital.

Brief summary: Patients with the APOE-ε4 genotype are at increased risk of both vascular dementia and peripheral vascular disease. Patients undergoing major vascular surgery are at particularly high risk of delirium and other, more subtle, changes in cognitive function following surgery. The hypothesis of this trial is that the APOE-ε4 genotype is associated with both delirium and postoperative cognitive dysfunction (POCD).


Eligibility criteria: Inclusion Criteria:

* Age 60 or greater
* Open repair of the abdominal aorta

Exclusion Criteria:

* refusal;
* planned endovascular repair;
* emergency surgery;
* previous diagnosis of dementia, Parkinson's disease, or psychiatric illness;
* active alcohol or substance abuse; and
* physical inability to complete neuropsychometric testing.

Primary outcomes:
measure: Delirium as assessed by the Confusion Assessment Method
timeFrame: 7 days postoperatively
Secondary outcomes:
measure: POCD as assessed by a battery of 9 neuropsychometric tests
timeFrame: 7 days postoperatively
measure: POCD as assessed by a battery of 9 neuropsychometric tests
timeFrame: 3 months postoperatively
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: The Ottawa Hospital - Civic Campus
state: Ontario
Study officials:
affiliation: Department of Anesthesiology, The Ottawa Hospital
name: Gregory L Bryson, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bryson GL, Wyand A, Wozny D, Rees L, Taljaard M, Nathan H. A prospective cohort study evaluating associations among delirium, postoperative cognitive dysfunction, and apolipoprotein E genotype following open aortic repair. Can J Anaesth. 2011 Mar;58(3):246-55. doi: 10.1007/s12630-010-9446-6. Epub 2011 Jan 11.
citation: Bryson GL, Wyand A, Wozny D, Rees L, Taljaard M, Nathan H. The clock drawing test is a poor screening tool for postoperative delirium and cognitive dysfunction after aortic repair. Can J Anaesth. 2011 Mar;58(3):267-74. doi: 10.1007/s12630-010-9448-4. Epub 2010 Dec 31.
Clinical trial NCT01588977: Subchondral Microfracture of Tibia After Arthroscopic Anterior Cruciate Ligament Surgery Reconstruction
Official title: Subchondral Microfracture of Tibia After Arthroscopic Anterior Cruciate Ligament Surgery Reconstruction With Two Different Drilling Techniques. Correlation With Postoperative Pain
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anterior Cruciate Ligament Reconstruction
Subchondral Microfractures of Tibia
Lead sponsor: Hospital Ambroise Paré Paris
Sponsor class: OTHER
First posted: 2012-05-01
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary arthroscopic reconstruction surgery of an Anterior Cruciate Ligament tear

Brief summary: The arthroscopic anterior cruciate (ACL) ligament reconstruction surgery is widespread. The creation of the tibial tunnel, retrograde or antegrade, is not consensual. A cadaveric study demonstrated tibial subchondral microfractures in the group "antegrade tibial tunnel" unlike group "retrograde tibial tunnel." To our knowledge, no clinical evaluation was performed. The investigators hypothesize that retrograde drilling will cause less local bone injury than antegrade drilling in creation of the tibial tunnel for ACL reconstruction.


Eligibility criteria: Inclusion Criteria:

* arthroscopic reconstruction surgery of an Anterior Cruciate Ligament tear

Exclusion Criteria:

* previous reconstruction of ACL
* associated lesions (meniscal tear, other ligament...)
* Refusal consent

Primary outcomes:
measure: Subchondral microfracture of tibia on MRI
timeFrame: 2 days after surgery
Secondary outcomes:
measure: Pain on Visual Analogue Scale
timeFrame: During two days after surgery, twice a day
Other outcomes:
Locations:
city: Boulogne-Billancourt
country: France
facility: Ambroise Paré Hospital
city: Nantes
country: France
facility: Hôtel-Dieu CHU Nantes
city: Saint-Nazaire
country: France
facility: Polyclinique de L'Europe
Study officials:
References:
Clinical trial NCT06361277: To Evaluate the Pharmacokinetic Characteristics and Safety in Healthy Volunteers
Official title: A Randomized, Open-label, Single Dose, Crossover Study to Compare the Pharmacokinetic Characteristics and Safety of JW0202 and C2202 or C2205 and JW0201 After Oral Administration in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: JW Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2024-04-11
Enrollment: 56
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: OTHER

Brief summary: The objective is to evaluate the safety and pharmacokinetic characteristics after co-administration of JW0202 and C2202 and co-administration of C2205 and JW0201 in healthy volunteers under fasting conditions

Detailed description: Pharmacokinetic characteristics: Describes the blood concentration statistically by pharmacokinetic blood collection time and treatment group.

Safety: All adverse events are summarized in terms of the number of subjects, expression rate, and number of expressions of adverse reactions by treatment group.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers

Exclusion Criteria:

* Subjects does not meet the Inclusion Criteria

Primary outcomes:
measure: AUCt
timeFrame: Day1 0h ~ Day3 48h
measure: Cmax
timeFrame: Day1 0h ~ Day3 48h
Secondary outcomes:
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Clinical Trial Center, Jeonbuk National University Hospital
Study officials:
affiliation: Jeonbuk National University Hospital
name: MinGul Kim
role: PRINCIPAL_INVESTIGATOR
References: