louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05208957: Cardiovascular Outcomes and Mortality in Vascular Surgical Patients
Official title: Cardiovascular Outcomes and Mortality in Vascular Surgical Patients. A Registry-based Study of in Hospital Mortality and Postoperative Complications in Elective Vascular Surgery at Groote Schuur Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Perioperative Complication
Cardiovascular Complication
Lead sponsor: University of Cape Town
Sponsor class: OTHER
First posted: 2022-01-26
Enrollment: 175
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population comprises all patients, 18 years and older, undergoing any elective moderate- to high-risk vascular surgical intervention at Groote Schuur Hospital. Surgical risk as defined by ESC/ESA 2014 guidelines.

Brief summary: This is a registry-based study of elective vascular surgical patients undergoing intermediate or high-risk vascular surgical interventions at Groote Schuur hospital, a tertiary academic center, over a 12 month period.


Eligibility criteria: Inclusion Criteria:

-

All patients undergoing vascular surgery:

1. 18 years and older
2. Elective procedures
3. Moderate- to high-risk surgical interventions

Exclusion Criteria:

1. Emergency vascular procedures
2. Low risk vascular surgery, i.e. venous stripping
3. All non-vascular surgical interventions

Primary outcomes:
measure: Determine in-hospital mortality in elective vascular surgical patients
timeFrame: 12 months
Secondary outcomes:
measure: Determine incidence of MACE in elective vascular surgical patients.
timeFrame: 12 months
measure: Describe the risk factors associated with MACE in elective vascular surgical patients
timeFrame: 12 months
measure: Determine incidence of post-operative complications in elective vascular surgical patients
timeFrame: 12 months
Other outcomes:
Locations:
city: Cape Town
country: South Africa
facility: Groote Schuur Hospital
state: Western Cape
Study officials:
affiliation: University of Cape Town
name: Christella Alphonsus, MBChB
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05996757: Effect of Wet Clothing Removal Compared to Use of a Vapor Barrier in Accidental Hypothermia
Official title: Effect of Wet Clothing Removal in the Treatment of Accidental Hypothermia: A Human Crossover Field Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Accidental Hypothermia
Emergencies
Keywords: Accidental hypothermia
Mountain Medicine
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
First posted: 2023-08-18
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The optimal method of prehospital insulation and rewarming of hypothermic patients have been subject of debate, and there is a substantial lack og high-quality evidence to guide providers.

One question concerns whether or not the patients clothing should be removed prior to being wrapped in an insulating model with a vapor barrier. Evaporative heat loss is one of four mechanisms of heat loss, and preventing evaporative heat loss should be a prioritized task for providers. Removal of wet clothing usually means subjecting the patient to the environment, but will reduce the evaporative heat loss considerably. An other alternative is to encapsulate the patient in a vapor barrier. Evaporative heat loss will stop when the humidity inside the vapor barrier reaches 100%.

We aim to investigate whether it is recommended to removed wet clothing or encase the patient in a vapor barrier.


Eligibility criteria: Inclusion Criteria:

* Age \<18
* American Society of Anaesthesiologists class 1
* No nicotine use

Exclusion Criteria:

* Acute illness on study day, fever or malaise

Primary outcomes:
measure: Mean skin temperature
timeFrame: 60 minutes
Secondary outcomes:
measure: Subjective thermal comfort and shivering
timeFrame: 60 minutes
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
Study officials:
affiliation: Haukeland University Hospital
name: Øyvind Thomassen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Henriksson O, Lundgren PJ, Kuklane K, Holmer I, Giesbrecht GG, Naredi P, Bjornstig U. Protection against cold in prehospital care: wet clothing removal or addition of a vapor barrier. Wilderness Environ Med. 2015 Mar;26(1):11-20. doi: 10.1016/j.wem.2014.07.001.
Clinical trial NCT03864757: APrevent Vocal Implant System (VOIS) for Adjustable Treatment of Unilateral Vocal Fold Paralysis (UVFP)
Official title: APrevent Vocal Implant System (VOIS) for Adjustable Treatment of Unilateral Vocal Fold Paralysis (UVFP) - an Open-label, Non-randomized Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Paralysis, Unilateral, Vocal Cord
Keywords: unilateral vocal fold paralysis
type I thyroplasty
Lead sponsor: APrevent Biotech GmbH
Sponsor class: INDUSTRY
First posted: 2019-03-06
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The objective of this study is to evaluate pre- and intraoperative voice quality, the degree of vocal fold closure and the Maximum Phonation Time (MPT), first determined after temporary APrevent® VOIS implantation and then after permanent existing product implantation.


Eligibility criteria: Inclusion Criteria:

* Male and female patients between 18 and 80 years
* Diagnosed with permanent UVFP and insufficient glottal closure and planned type I thyroplasty with conventional implant
* Ability to co-operate with the investigator and to comply with the requirements of the entire study

Exclusion Criteria:

* Any other significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the clinical investigation may influence the result of the clinical investigation, or the participant's ability to participate in the clinical investigation
* Scheduled elective surgery or other procedures requiring general anaesthesia during clinical investigation
* Had medialization thyroplasty before
* Had injection medialization laryngoplasty in the past two years.
* Presence of structural vocal fold lesions such as polyp or nodules
* Status post total cordectomy
* Previous laryngeal framework surgery (any type of thyroplasty, arytenoid adduction)
* Significant non-laryngeal speech abnormality (severe dysarthria determined by a panel of trained speech therapists)
* Severe coagulopathy

Primary outcomes:
measure: Change in voice quality by RBH-Scale
timeFrame: pre-surgery, right after temporarily implantation
measure: Change in Glottal closure by Södersten and Lindestad classification
timeFrame: pre-surgery, right after temporarily implantation
measure: Change in maximum phonation time in seconds
timeFrame: pre-surgery, right after temporarily implantation
Secondary outcomes:
measure: Evaluation of surgical handling and device fitting using a VAS scale
timeFrame: right after temporarily implantation
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna
Study officials:
affiliation: Medical University of Vienna
name: Berit Schneider-Stickler, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05865457: Efficacy and Safety of BUFY02 Versus TRB02 in the Treatment of Dry Eye Disease
Official title: Efficacy and Safety of BUFY02 Versus TRB02 in the Treatment of Dry Eye Disease: a Non-inferiority Investigation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dry Eye Disease
Lead sponsor: TRB Chemedica International SA
Sponsor class: INDUSTRY
First posted: 2023-05-18
Enrollment: 80
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 goal of this interventional investigation is to compare BUFY02 with TRB02 in the treatment of patients with dry eye disease. The main questions it aims to answer are:

* Is BUFY02 non-inferior to TRB02 in terms of signs of DED?
* Is BUFY02 non-inferior to TRB02 in terms of symptoms of DED?

Participants will be asked to:

* Visit the trial site at 4 different timepoints
* Use the allocated study treatment everyday until the end of the study (during 3 months)
* Be examined by the investigator
* Complete several questionnaires
* Return unused study treatment.

Researchers will compare BUFY02 to TRB02 to see if both study treatments provide similar effects on signs and symptoms of the disease, together with comparable safety.


Eligibility criteria: Inclusion Criteria include:

* At least a 3-month documented history of bilateral dry eye syndrome needing artificial tears;
* At least one eye with Oxford score ≥ 4 and ≤ 9;
* At least one objective sign of tear deficiency (in at least one eligible eye);
* Having a health insurance.

Exclusion Criteria include:

* Wear of contact lenses starting within the last 2 months;
* Best-corrected visual acuity (BCVA) \< 1/10;
* Severe DED with one of the listed conditions:
* Severe blepharitis;
* Seasonal allergy;
* Any issues of the ocular surface not related to DED;
* History of ocular trauma, infection or inflammation not related to DED;
* History of ocular surgery, including laser surgery;
* Unstable glaucoma;
* Use of artificial tears with preservative within the last 2 weeks;
* Systemic (enteral or parenteral) or local (topical) use of one of the listed medications:
* Known hypersensitivity to any constituent of the study treatments;
* Pregnancy or breastfeeding;
* Participation in another clinical study within the last 90 days;
* Legally restricted autonomy, freedom of decision and action.

Primary outcomes:
measure: Signs
timeFrame: Day 28
Secondary outcomes:
measure: Symptoms
timeFrame: Day 28
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00129857: Dexanabinol in Severe Traumatic Brain Injury
Official title: Efficacy and Safety Evaluation of a Single Intravenous Dose of Dexanabinol in Patients Suffering From Severe Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Traumatic Brain Injury
Lead sponsor: Pharmos
Sponsor class: INDUSTRY
First posted: 2005-08-12
Enrollment: 860
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Each year a large number of patients are hospitalized at Shock Trauma Centers with severe head injuries. Bleeding into and swelling of these patients' brains may cause compression of vital structures, disability and death. Sometimes surgery is needed. Unfortunately, the investigators have no medication to treat the bad effects of head trauma. Part of the brain damage is due to toxic chemicals (including one called glutamate) that are released by the damaged nerves. Dexanabinol may prevent some of the bad effects of glutamate on the brain and may protect the brain against uncontrollable swelling and death.

Detailed description: Dexanabinol is a synthetic, non-psychotropic cannabinoid derivative that because of its dextro-configuration is compatible with activation of cannabinoid receptors in the brain. It combines the ability to block NMDA receptors and neuroinflammatory cascades in the same molecule. Dexanabinol scavenges free radicals, protects neurons from toxicity of free radical generators and inhibits lipopolysaccharide-induced production of prostaglandin E2, NO and TNF-a by macrophages in culture.

Eligibility criteria: Inclusion Criteria:

* Traumatic head injury within the last 6 hours
* Glasgow Coma Motor score of 2 to 5; severity requires intracranial pressure (ICP) monitoring
* Brain computed tomography (CT) showing intracranial parenchymal abnormality and hemodynamically stable
* An informed consent

Exclusion Criteria:

* Penetrating head injury
* Spinal cord injury
* Coma due to pure epidural hematoma with initial Glasgow Coma Scale (GCS) of =\> 12
* Previous major cerebral damage
* Concomitant severe conditions

Primary outcomes:
measure: Glasgow Outcome Scale Extended (GOSE) at 6 months
Secondary outcomes:
measure: GOSE at 3 months
measure: Mortality rates at 10 days and 6 months
measure: Intracerebral pressure during first 72 hours of trauma
measure: Neuroworsening at 10 days
measure: Quality of life
Other outcomes:
Locations:
Study officials:
affiliation: Dept. of Neurosurgery, Dijkzigt Hospital, Rotterdam, Holland
name: Andrew Maas, M.D.
role: STUDY_CHAIR
References:
citation: Maas AI, Murray G, Henney H 3rd, Kassem N, Legrand V, Mangelus M, Muizelaar JP, Stocchetti N, Knoller N; Pharmos TBI investigators. Efficacy and safety of dexanabinol in severe traumatic brain injury: results of a phase III randomised, placebo-controlled, clinical trial. Lancet Neurol. 2006 Jan;5(1):38-45. doi: 10.1016/S1474-4422(05)70253-2.
Clinical trial NCT00805857: Surveillance Cohort Long-term Toxicity Antiretrovirals in HIV-infected Patients Enrolled in TPV Cohort
Official title: SCOLTA: SURVEILLANCE COHORT LONG-TERM TOXICITY ANTIRETROVIRALS
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: HIV Infections
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2008-12-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: The SCOLTA project is a system for online surveying of adverse events to recently commercialized antiretroviral drugs and a sentinel for unexpected and late adverse events reactions arising during any antiretroviral treatment.Aim of the proposed study is:

1. to evaluate the prevalence and incidence of serious adverse events and serious unexpected adverse events in HIV-infected patients enrolled in the SCOLTA project Tipranavir cohort and to identify possible risk factors
2. the evaluation of tipranavir containing regimens durability, considering treatment interruption for each reason.


Eligibility criteria: Inclusion Criteria:

* All patients \> 18 years old HIV infected treated with tipranavir

Exclusion Criteria:

Primary outcomes:
measure: To evaluate the prevalence and incidence of serious adverse events and serious unexpected adverse events in HIV infected patients enrolled in Tipranavir cohort and to identify possible risk factors
timeFrame: 48wks
Secondary outcomes:
measure: the evaluation of tipranavir containing regimens durability, considering treatment interruption for each reason
timeFrame: 48wks
Other outcomes:
Locations:
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
Clinical trial NCT00484757: Effect of Intranasal Administration of Orexine A on IL-6-System, Sleep-Wake-Regulation and Neurocognition
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Narcolepsy
Keywords: Narcolepsy
Orexines
sleep
cognition
cytokines
Lead sponsor: Zentrum für Integrative Psychiatrie
Sponsor class: OTHER
First posted: 2007-06-11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: 15 patients with narcolepsy and 15 healthy controls will be included in the study. According to a randomized, double-blind protocol they will receive intranasally at night first Orexine A and approximately two weeks later placebo or vice versa. Thereafter sleep will be recorded, the cytokine-system and neurocognition characterized.


Eligibility criteria: Inclusion Criteria:

* Narcolepsy
* Age \>18
* Informed consent
* GERMAN fluently spoken

Exclusion Criteria:

* Additional severe psychiatric or somatic disorders
* Pregnancy or nursing
* Anemia (Hb\<10g/dl)

Primary outcomes:
measure: Effect of orexine A on sleep, neurocognition and immune-system
Secondary outcomes:
Other outcomes:
Locations:
city: Kiel
country: Germany
facility: Zentrum für Integrative Psychiatrie
Study officials:
affiliation: Zentrum für Integrative Psychiatrie
name: Dunja Hinze-Selch, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01128257: A Study of Ibandronate [Bonviva/Boniva] and Alendronate in Female Patients With Post-Menopausal Osteoporosis
Official title: Controllability and Real Life Efficacy of Bonviva 3 mg iv Quarterly vs. Oral Alendronate Generics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postmenopausal Osteoporosis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-05-21
Enrollment: 6054
Sex: FEMALE
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Female post-menopausal patients over the age of 55 years

Brief summary: This observational study will assess the compliance and persistence of patients, real life efficacy and safety of intravenously quarterly administered 3 mg ibandronate \[Bonviva/Boniva\] in comparison to oral alendronate generics in female patients with post-menopausal osteoporosis. The anticipated time of assessment is 12 months. The target sample size is 5000-7000 patients.


Eligibility criteria: Inclusion Criteria:

* Adult patients, \>/= 55 years of age
* Postmenopausal osteoporosis
* Patients who are in the opinion of the physician eligible to participate in this study

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Assessment of compliance and persistence of Bonviva therapy: Number of prescriptions, number of applied injections, number of taken oral medication, continuation and duration of treatment
timeFrame: 12 months
Secondary outcomes:
measure: Pain intensity and reduction in use of analgesics
timeFrame: 12 months
measure: Quality of life and patients satisfaction
timeFrame: 12 months
measure: Degree of patient's mobility
timeFrame: 12 months
measure: Incidence of new osteoporotic fractures
timeFrame: 12 months
measure: Controllability and management of therapy by the physician
timeFrame: 12 months
measure: Patient baseline characteristics
timeFrame: 12 months
measure: User friendliness
timeFrame: 12 months
measure: Safety: AEs and SAEs
timeFrame: 12 months
Other outcomes:
Locations:
city: Marburg
country: Germany
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT03195257: Glucose-Dependent Insulinotropic Polypeptide - Effects on Markers of Bone Turnover in Patients With Type 1 Diabetes
Official title: Glucose-Dependent Insulinotropic Polypeptide - Effects on Markers of Bone Turnover in Patients With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
First posted: 2017-06-22
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Investigate GIP effects on biomarkers involved in bone homeostasis


Eligibility criteria: Inclusion Criteria:

* Patients with type 1 diabetes (positive islet cell/ glutamic acid decarboxylase-65 antibodies)
* Patients without measurable beta cell function (i.e. incremental C-peptide below detection limit (\<0.16 nmol/l) following an 5 g-iv-arginine stimulation test,

Exclusion Criteria:

* HbA1c \>9% (75 mmol/mol),
* standard plasma biochemical measurements outside normal reference interval (alanine aminotransferase, bilirubin, thyroid-stimulating hormone, hemoglobin, creatinine, and spot urine albumin-creatinine ratio);
* an abnormal state of hypoglycemia awareness,
* significant diabetic complications (i.e. proliferative diabetic retinopathy, neuropathy, severe atherosclerosis, heart disease) and,
* treatment with medication (besides insulin) that could not be paused for 12 hours up to and during the days of the experiments.

Primary outcomes:
measure: C-terminal telopeptide of type I collagen (CTX).
timeFrame: 30 minutes intervals, time 0 up to 120 min
Secondary outcomes:
measure: Parathyroid hormone (PTH)
timeFrame: 30 minutes intervals, time 0 up to 120 min
measure: N-terminal propeptide of type 1 procollagen (P1NP).
timeFrame: 30 minutes intervals, time 0 up to 120 min
Other outcomes:
Locations:
Study officials:
References:
citation: Christensen MB, Lund A, Calanna S, Jorgensen NR, Holst JJ, Vilsboll T, Knop FK. Glucose-Dependent Insulinotropic Polypeptide (GIP) Inhibits Bone Resorption Independently of Insulin and Glycemia. J Clin Endocrinol Metab. 2018 Jan 1;103(1):288-294. doi: 10.1210/jc.2017-01949.
Clinical trial NCT03723057: Expanded Access for AG-221
Official title: Expanded Access for AG-221
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Acute Myeloid Leukemia
Keywords: Expanded Access
Compassionate Use
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2018-10-29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: This is an expanded access program (EAP) for eligible participants designed to provide access to AG-221.


Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

-

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Summit
country: United States
facility: Celgene
state: New Jersey
Study officials:
References:
Clinical trial NCT03138057: BM Characterization Pilot
Official title: Comparison of Fecal Digestive Enzymes in Infant Aged Between 0-1 Years Old
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diaper Rash
Lead sponsor: Kimberly-Clark Corporation
Sponsor class: INDUSTRY
First posted: 2017-05-03
Enrollment: 25
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sample of male and female infants who are not formula fed

Brief summary: This is a prospective, pilot study to explore the relationship between an infant's nutrition, skin and stool composition at different ages.


Eligibility criteria: Inclusion Criteria:

* Infants aged 0-12 months

Exclusion Criteria:

* Formula Fed
* Use of topical or oral antibiotics or antifungals within the past 4 weeks

Primary outcomes:
measure: To determine enzymes in infant stools
timeFrame: approximately 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: Midwest Children's Health Research Institute
state: Nebraska
Study officials:
affiliation: Midwest Children's Health Research Institute
name: Amy Bargen, MD
role: PRINCIPAL_INVESTIGATOR
References: