louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04928378: Bone Resistant Tuberculosis
Official title: Management of Osteoarticular Infection Due to Multidrug Resistant Mycobacterium Tuberculosis Strains in France
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bone and Osteoarticular Infection Due to MDR M. Tuberculosis Strains
Keywords: Mycobacterium tuberculosis
Multi drug resistance
Bone
osteoarticular
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2021-06-16
Enrollment: 23
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients registered in the database of the National Reference Center (CNR) for MDR IOATB in France, treated for MDR IOATB between January 1, 2007 and December 31, 2018 will be included and analyzed.

Brief summary: The recommendations for the treatment of MDR tuberculosis are based on pulmonary tuberculosis since there is a lack of specific recommendations for TB bone and osteoarticular disease, including those due to multi drug resistance strains (MDR IOATB). Given the lack of data regarding MDR IOATB, it may be helpful to study the diagnosis, medical treatment, surgical indications and prognosis of a cohort of MDR IOATB patients.

Detailed description: Due to the lack, in the guidelines regarding bone and osteoarticular infections due to MDR M. tuberculosis strains, this study aims to characterize the diagnosis, management and outcome of patients with osteoarticular infection due to MDR M. tuberculosis in France (MDR IOATB).

Aim: descriptive study of diagnosis, therapeutics and outcome of patients with bone and osteoarticular infection with MDR IOATB in France.

Set up: patients registered in the database of the National Reference Center (CNR) for MDR IOATB in France, treated for MDR IOATB between January 1, 2007 and December 31, 2018 will be included and analyzed.

Study design: retrospective study on historical cohort

Eligibility criteria: Inclusion Criteria:

* Any patient with an MDR IOATB whose sample and / or strain has been referred to the National Reference Center (CNR) for mycobacteria in France, will be included.

Exclusion Criteria:

* Patient refusing to have their data used.
* Patients under guardianship or curators, patients under legal protection will not be included.

Primary outcomes:
measure: study of infected population with MDR TB IOATB
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Drug susceptibility testing
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Paris
country: France
facility: Pitié Salpêtrière Hospital
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Alexandra Aubry, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06006078: Aersosolization During Upper Endoscopy
Official title: Does Use of a Facemask Reduce the Risk of Aerosolization During Anesthesia Assisted Upper Endoscopic Procedures: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infectious
Gastro-Intestinal Disorder
Safety Issues
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2023-08-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: One group of patients will be randomly assigned to receive an endoscopic facemask and one group of patients will undergo endoscopy without a facemask.
Primary purpose: PREVENTION

Brief summary: Given the current Covid-19 pandemic alongside the lack of evidence on aerosolization during upper endoscopy the investigators are conducting a randomized controlled trial seeking to assess both the level of aerosolization that occurs during these procedures along with determining if utilization of an endoscopic patient face-masks reduces the level of aerosolized particles. The protocol includes the use of a commercially available particle counter the investigators are employing for the measurement of aerosols before, during, and after anesthesia assisted upper endoscopic procedures. The investigators are recruiting patients undergoing these procedures with a target of 30 patients undergoing endoscopy without a facemask and 30 patients undergoing endoscopy with one.


Eligibility criteria: Inclusion Criteria:

* All patients undergoing elective upper endoscopic procedures (upper endoscopy, ERCP, endoscopic ultrasound) with monitored anesthesia care at main campus Cleveland Clinic inpatient endoscopy unit.

Exclusion Criteria:

* Any patient requiring endotracheal intubation
* Pregnant patients
* Emergency procedures
* Patients who require use of a facemask before or during the procedure due to medical necessity
* Patients under the age of 18
* Non-English speaking individuals
* Patients unable to provide consent.
* Any procedure done outside the designated procedure room.
* If in the opinion of the anesthesiologist, a subject who was randomized to the control arm requires placement of the procedural mask to augment oxygenation, the subject will be removed from the study

Primary outcomes:
measure: Aersolization of particles during upper endoscopy
timeFrame: Start of endoscopy through the end of endoscopy
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
Study officials:
affiliation: Physician
name: John Vargo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05530278: A Study to Assess the Pharmacokinetics and Safety of Co-administered Oral Galicaftor, Navocaftor, and ABBV-576 in Healthy Adults for the Treatment of Cystic Fibrosis
Official title: Assessment of Multiple-Dose Pharmacokinetics and Safety of the Co-administration of Galicaftor, Navocaftor and ABBV-576 and Potential of ABBV-576 for CYP3A Induction in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Galicaftor
Navocaftor
ABBV-576
Cystic Fibrosis
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2022-09-07
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cystic Fibrosis (CF) is a rare, life-threatening, genetic disease that affects the lungs and digestive system, significantly impairing the quality of life, with those affected having a median age of death at 40. The main objectives of this study are to assess the safety and pharmacokinetics of the combination therapy of galicaftor/navocaftor/ABBV-576.


Eligibility criteria: Inclusion Criteria:

* Body Mass Index (BMI) is ≥ 18.0 to ≤ 29.9 kg/m2 after rounding to the tenths decimal.
* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG).

Exclusion Criteria:

* History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.
* History of any clinically significant sensitivity or allergy to any medication or food.
* History of any clinically significant condition listed in the protocol.

Primary outcomes:
measure: Maximum Plasma Concentration (Cmax)
timeFrame: Up to Day 52
measure: Time to maximum observed plasma concentration (Tmax)
timeFrame: Up to Day 52
measure: Apparent terminal phase elimination rate constant (BETA or β)
timeFrame: Up to Day 52
measure: Mean terminal phase elimination half-life (t1/2)
timeFrame: Up to Day 52
measure: Area under the plasma curve (AUC)
timeFrame: Up to Day 52
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Up to Day 82
Secondary outcomes:
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Anaheim Clinical Trials LLC /ID# 248824
state: California
city: Miami
country: United States
facility: Clinical Pharmacology of Miami /ID# 248823
state: Florida
city: Las Vegas
country: United States
facility: PPD Clinical Research Unit -Las Vegas /ID# 248853
state: Nevada
city: Austin
country: United States
facility: PPD Clinical Research Unit - Austin /ID# 248854
state: Texas
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References:
Clinical trial NCT04665778: Prediction of the Patient Pathway in Emergency Room in an Exceptional Sanitary Situation
Official title: Prediction of the Patient Pathway in Emergency Room in an Exceptional Sanitary Situation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Emergencies
Keywords: Covid19
patient flow
emergency overcrowding
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2020-12-14
Enrollment: 1516
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients that consults in adult emergency department should be included

Brief summary: The COVID-19 outbreak leads to optimize the pathway in emergency departments. The length of time spent in the Emergency Department is linked to the morbi-mortality and the risk of COVID-19 transmission. The Amiens-Picardy University Hospital has developed an application (3P-U) that optimizes patient flow. It identifies the need of hospitalization and problems on the care path. Patients are categorized in high risk or not high probabilty of hospitalization. The main goal of this project is to evaluate the impact on the patient flow of the 3P-U application. Early lookup of bed for high probability hospitalization should be linked to a reduced time of length. This study will compare the time of length between this both groups.


Eligibility criteria: Inclusion Criteria:

* every patient that consults in the Adult Emergency Department

Exclusion Criteria:

* patients directly transferred to Intensive Care Units

Primary outcomes:
measure: Variation of the length of stay between high probability of hospitalization group and not high risk of hospitalization group.
timeFrame: up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
References:
Clinical trial NCT05734378: Prognosis of Cerebral Small Vessel Disease
Official title: Prognosis of Cerebral Small Vessel Disease - a Prospective Cohort Study (PRO-SVD)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cerebral Amyloid Angiopathy
Small Vessel Cerebrovascular Disease
Cadasil
CAA - Cerebral Amyloid Angiopathy
Keywords: small vessel disease
CAA
cerebral amyloid angiopathy
hypertensive arteriopathy
deep perforator arteriopathy
CADASIL
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2023-02-17
Enrollment: 900
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This is a prospectively recruited cohort of patients treated with cerebral small vessel disease at Inselspital Bern University Hospital. Patients are recruited at the emergency department, neurology in-patient ward, Stroke Unit, IMC, ICU and outpatient clinics.

Brief summary: Prognosis of small vessel disease (SVD) depends on the underlying type of SVD and index manifestation.

The aim of this prospective, observational cohort study is to determine the risk of different outcome events among patients with SVD according to the type of index presentation.


Eligibility criteria: Inclusion Criteria:

* Hypertensive deep perforator arteriolopathy (DPA), clinically symptomatic with either ICH, ischaemic stroke, cognitive impairment or severe radiological manifestation (Fazekas ≥II)
* Cerebral amyloid angiopathy (CAA according to modified Boston or Edinburgh criteria), clinically symptomatic with either ICH (including cSAH), amyloid spells, cognitive impairment or severe radiological manifestation (CMB≥2)
* Other SVD (i.e. CADASIL or other sporadic or genetic SVD)

Exclusion Criteria:

* Life expectancy of \<6 months due to not-SVD related causes (i.e. cancer)
* Patient is unlikely to attend follow-up visits

Primary outcomes:
measure: Intracerebral haemorrhage (ICH)
timeFrame: 1 year
measure: Ischaemic stroke
timeFrame: 1 year
measure: Cardio-vascular death
timeFrame: 1 year
Secondary outcomes:
measure: Other intracranial bleeding
timeFrame: 1 year
measure: Other (transient) neurological attacks
timeFrame: 1 year
measure: Cognitive impairment
timeFrame: 1 year
measure: New-onset of extracranial vascular disease
timeFrame: 1 year
measure: Functional outcome
timeFrame: 1 year
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Department of Neurology, Inselspital Bern University Hospital
Study officials:
affiliation: Department of Neurology, Inselspital Bern University Hospital
name: David J Seiffge, Prof, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06033378: Blood Pressure Treatment in ICU Patients with Subarachniodal Haemorrhage.
Official title: Blood Pressure Treatment in ICU Patients with Subarachniodal Haemorrhage. -Can Blood Pressure Be Used As a Surrogate Marker for Blood Flow
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Blood Pressure
Subarachnoid Hemorrhage
Aneurysm Cerebral
Keywords: magnetic resonance imaging
norepinephrine
blood flow
Lead sponsor: Umeå University
Sponsor class: OTHER
Collaborators: name: Region Västerbotten
First posted: 2023-09-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: An MRI study to examine the relationship between blood pressure and cerebral blood flow in patients with subarachnoidal hemorrhage and suspect or verified vasospasm.

Detailed description: Subarachnoidal hemorrhage (SAH) is a type of stroke with high mortality rates and often requires care at the intensive care unit. Cerebral blood flow (CBF) needs to be ensured so that the brain receives optimal nourishment, and this is largely controlled by regulating blood pressure (BP) using medications that affect the heart and blood vessels. Approximately 3-7 days after SAH onset, vasospasm (SAH-V) can occur. Treatment usually includes maintaining blood pressure (BP) above a certain threshold to achieve adequate cerebral blood flow (CBF). An important component of raising BP is increasing vascular resistance using vasoconstrictive medications, which paradoxically can decrease CBF.

The study objective is to investigate the correlation between BP changes and their impact on CBF in patients with suspect or verified SAH-V using MRI.

To achieve this purpose, the investigators plan to examine the relationship between BP and CBF in patients with SAH-V who require neuro-intensive care. To measure CBF, two techniquis will be used: phase-contrast MRI and arterial spin labeling.

Flow measurement with MRI:

1. Baseline images will be acquired at baseline blood pressure.
2. Mean arterial pressure (MAP) will be increased using norepinephrine. New images will be acquired when MAP is increased by approximately 20-30% from the baseline.

All BP levels will be maintained within clinically acceptable ranges. All data will be recorded in the patient's medical record, and MRI images will be processed at a later stage.

Eligibility criteria: Inclusion Criteria:

* Coiled or clipped aneurysm
* Suspected or confirmed vasospasm

Exclusion Criteria:

* BMI \>30
* Pregnancy
* Pacemaker or other MRI contraindications
* Severe congestive heart failure (NYHA III-IV) or cardiac arrhythmia.
* Severe respiratory failure or FiO2 \>0.6
* Severe kidney failure

Primary outcomes:
measure: Cerebral blood flow
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Umeå
country: Sweden
facility: Umeå University Hospital
Study officials:
affiliation: Region Västerbotten
name: Laleh Zarrinkoob
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00174278: Treatment With Recombinant Human Growth Hormone Genotonorm (Registered) In Children With Short Stature Secondary
Official title: Treatment With Recombinant Human Growth Hormone (Genotonorm®) In Children With Short Stature Secondary To A Long Term Corticoid Therapy. A Study of Efficacy and Safety.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Growth Hormone Deficiency
Growth Retardation
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 14
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To assess the effect of long-term treatment by Genotonorm on linear growth


Eligibility criteria: Inclusion Criteria:

* All the patients who have benefit during one year of a treatment by Genotonorm during the study 94-8123-014
* All patients who have stopped during one year will be included if a signed written informed consent

Exclusion Criteria:

* Endocrine disease, except well substituted hypothyroidism
* Other severe chronic diseases (e.g. diabetes mellitus, cardiac or liver insufficiency)

Primary outcomes:
measure: The main efficacy variable is the height SDS (SEMPE) before and after treatment.
measure: The standing height of the patients is measured during the inclusion visit and at each follow-up visit.
measure: The height measurements are always performed at the same time of the day by
measure: use of a wallmounted device (e.g. Harpenden Stadiometer).
measure: Each child has to be measured three times, the mean of these measurements is recorded in the Case Report Form as the present height.
measure: The body weight is measured by use of a balance scale.
measure: Puberty stage is assessed (according to Tanner´s cotation) at the same visits as height is measured.
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: David H, Aupiais C, Louveau B, Quartier P, Jacqz-Aigrain E, Carel JC, Simon D. Growth Outcomes After GH Therapy of Patients Given Long-Term Corticosteroids for Juvenile Idiopathic Arthritis. J Clin Endocrinol Metab. 2017 Dec 1;102(12):4578-4587. doi: 10.1210/jc.2017-01455.
Clinical trial NCT02691078: Validation of 99mTc- EDDA - HYNIC -TOC Kits for Diagnosis of Neuroendocrine Tumors
Official title: Validation of 99mTc- EDDA - HYNIC -TOC Kits for Diagnosis of Neuroendocrine Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neuroendocrine Tumors
Lead sponsor: Latin American Cooperative Oncology Group
Sponsor class: OTHER
Collaborators: name: Financiadora de Estudos e Projetos
name: Instituto do Cérebro do Rio Grande do Sul - InsCer
First posted: 2016-02-25
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Evaluation of the properties of the image capture test using 99m Tc - HYNIC -TOC EDDA (octreotide labeled with 99mTc) for the diagnosis of neuroendocrine tumors compared to the 111In - DTPA-octreotide.


Eligibility criteria: Inclusion Criteria:

* Patients with histological diagnosis of neuroendocrine tumors
* Patients with indication for the staging exam with 11In
* Patients diagnosed in any tumor stage
* Patients with \> 18 years
* Male and female patients
* Patients not receiving somatostatin analogues for at least 1 month before image capturing

Exclusion Criteria:

* Pregnant women
* Patients with previous tumor resection of the primary tumor without metastatic disease

Primary outcomes:
measure: Analysis of the images captured with 99m Tc - HYNIC -TOC EDDA ( octreotide labeled with 99mTc ) and 111In - DTPA-octreotide for the diagnosis of neurocrine tumors
timeFrame: Up to 30 days
Secondary outcomes:
measure: Visualization of the ocurrence of the neuroendocrine tumor lesions with both radiopharmaceutical agents
timeFrame: Up to 30 days
measure: Number of neuroendocrine tumor lesions visualized with both radiopharmaceutical agents
timeFrame: Up to 30 days
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Instituto do Cérebro do Rio Grande do Sul
state: Rio Grande Do Sul
Study officials:
affiliation: Latin American Cooperative Oncology Group
name: Gustavo Werutsky, MD
role: STUDY_DIRECTOR
References:
citation: Moriguchi-Jeckel CM, Madke RR, Radaelli G, Viana A, Nabinger P, Fernandes B, Gossling G, Berdichevski EH, Vilas E, Giacomazzi J, Rocha MS, Borges JA, Hoffmann E, Greggio S, Venturin GT, Barrios CH, Zaffaroni F, Werutsky G, da Costa JC. Clinical validation and diagnostic accuracy of 99mTc-EDDA/HYNIC-TOC compared to 111In-DTPA-octreotide in patients with neuroendocrine tumours: the LACOG 0214 study. Ecancermedicalscience. 2023 Jul 26;17:1582. doi: 10.3332/ecancer.2023.1582. eCollection 2023.
Clinical trial NCT06567678: The Effect of Colchicine on Platelet Function Profiles in Patients With Stable Coronary Artery Disease
Official title: The Effect of Colchicine on Platelet Function Profiles in Patients With Stable Coronary Artery Disease in Trinidad and Tobago. The Pilot ECLIPSE Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Coronary Artery Disease
Lead sponsor: The University of The West Indies
Sponsor class: OTHER
First posted: 2024-08-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The effects of colchicine on cardiovascular health in patients with stable coronary artery disease have been shown to be beneficial due to its anti-inflammatory properties. This present study aims to explore the effects of colchicine on platelet reactivity in patients with coronary artery disease on dual antiplatelet therapy.

Detailed description: Recent landmark clinical trials on the use of colchicine in patients with chronic coronary artery disease has led to its implementation as an FDA approved drug for secondary prevention in patients with coronary artery disease. Colchicine exerts a range of anti inflammatory effects which plays a major role in reduction of atherosclerosis and prevention cardiovascular events. This current study aims to investigate the effect of colchicine on platelet reactivity in patients with stable coronary artery disease already on dual anticoagulants.

Eligibility criteria: Inclusion Criteria:

* Patients with stable coronary artery disease.
* Patients older than 18 years of age.
* Patients currently on dual anti platelets, aspirin and clopidogrel

Exclusion Criteria:

• Patients already on colchicine

Primary outcomes:
measure: P2Y12 reaction units and Aspirin reaction units
timeFrame: two weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Augustine
country: Trinidad and Tobago
facility: The University of The West Indies
Study officials:
affiliation: The University of The west Indies, Saint Augustine, Trinidad and Tobago.
name: Naveen Seecheran
role: PRINCIPAL_INVESTIGATOR
References: