louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05313100: Sugammadex and Smoker's Neuromuscular Block
Official title: The Evaluation of the Effects of the Use of Rocuronium and Sugammadex on Neuromuscular Block in Smoker
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Neuromuscular Blockade
Smoking
Keywords: sugammadex
smoking
neuromuscular blockade
Lead sponsor: Duzce University
Sponsor class: OTHER
First posted: 2022-04-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: We compared the durations of antagonizing and of the severity of effect of sugammadex used in antagonizing the rocuronium in smoker and non-smoker total 40 patients with using Train of Four(TOF) neuromuscular monitorization.

Detailed description: 40 patients from American Society of Anesthesiologist (ASA) I- II class, being smokers for at least 10 years or non-smokers, who will undergo elective surgery were included in this randomized prospective study. Patients underwent routine monitoring and neuromuscular monitoring. Propofol 2 mg/kg and intravenous fentanyl 1 mcg/kg were applied at induction. After the loss of eyelash reflex, intravenous rocuronium 0,6 mg/kg was administered. The patient was intubated at a Train of Four count of 2. Anesthesia was continued with 50% O2 + 50% air and sevoflurane 2 % . Rocuronium 0,15 mg/kg was administered when TOF (Train of Four) counter reached 2 during the operation. Sugammadex 2 mg/kg was administered at the end of the operation. The time to reach Train of Four values of 0,7-0,8-0,9 were recorded.

Eligibility criteria: Inclusion Criteria:

* Elective surgery,
* 1-2 according to the ASA ( American Society of Anesthesiologist ) physical status classification.
* Patients who have smoked at least 10 packs or have been smoking for 10 years and currently smoking
* Or never smoked patients

Exclusion Criteria:

* neuromuscular diseases
* radiotherapy and/or chemotherapy anamnesis,
* liver and/or renal disease,
* electrolyte balance,
* history of drug use which affects neuromuscular transmission,
* Body Mass Index (BMI) of more than 27,
* use alcohol

Primary outcomes:
measure: Neuromuscular block recovery time
timeFrame: six months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Duzce University
name: Gulbin Sezen
role: STUDY_DIRECTOR
References:
Clinical trial NCT04196400: The Role of Local Long Acting Corticosteroid Injection in Hypospadias Surgery.
Official title: Prospective Comparative Trial to Assess the Role of Local Long Acting Steroid Injection After Hypospadias Surgery in Decreasing Complications and Preserving Better Cosmesis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Hypospadias
Keywords: hypospadias, edema, failure, fistula, steroids
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-12-12
Enrollment: 40
Sex: MALE
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: comparative prospective clinical trial
Primary purpose: PREVENTION

Brief summary: Post-operative tissue oedema is one of the main causes of failure of hypospadias repair. Severe oedema may disrupt the suture line, invite infection and result in repair failure. Thus, we suggested that local injection of corticosteroids in just below coronal sulcus into dartos and buck's fascia may limit this oedema thus improving the outcome of hypospadias repair.

Detailed description: This is a prospective comparative trial : comparing the use of local steroids injection to reduce tissue edema after hypospadias and to preserve the final cosmesis after tissue repair.

The patients will be divided into 2 groups(each group 20 patients): one group will be injected steroids just after hypospadias surgery while the other will not.

The short and long term outcomes between both groups will be compared.

Eligibility criteria: Inclusion Criteria:

* Hypospadias Patient
* Recurrent Cases
* 6 months or more
* Distal, and mid penile hypospadias

Exclusion Criteria:

* None

Primary outcomes:
measure: Failure rate
timeFrame: 2 weeks
Secondary outcomes:
measure: incidence of Tissue edema
timeFrame: 3 days, 5 days, 10 days, 2 weeks
measure: Infection Rate
timeFrame: 3 days, 5 days, 10 days, 2 weeks
measure: Fistula rate
timeFrame: 2 weeks
measure: Final cosmesis
timeFrame: 3 days, 5 days, 10 days, 2 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo Univeristy Hospital
Study officials:
References:
Clinical trial NCT03900000: Improved Orthostatic Tolerance = Better Cognitive Function in Parkinson's Disease
Official title: Improved Orthostatic Tolerance = Better Cognitive Function in Parkinson's Disease: Does a Successful Treatment of Orthostatic Hypotension Measurably Enhance Attention and Memory Functions in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypotension, Orthostatic
Parkinson Disease
Autonomic Failure
Cognitive Impairment
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2019-04-02
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: Study on orthostatic Hypotension in Parkinson's disease

Detailed description: Orthostatic hypotension (OH) in Parkinson's disease (PD) may not only be related to dizziness or light headedness but to deficits in attention, visual, and verbal memory. Would a successful treatment of OH which includes physiotherapy significantly improve OH and these cognitive deficits? By means of a randomized cross-over trial, we want to measure and compare the effects of OH therapy on orthostatic tolerance, as well as on attention, visuo-spatial working memory, and verbal memory in patients with PD. If confirmed, therapy of orthostatic hypotension would provide a sound and simple approach to improve those cognitive deficits originating from orthostatic hypotension.

Eligibility criteria: Inclusion Criteria:

* Parkinson's patients
* Diagnostis of OH
* able to perform an ambulatory physiotherapy at Aachen University Hospital.

Exclusion Criteria:

* deep brain stimulation or Pacemaker
* severe psychiatric disease
* severe heart disease
* severe vascular encephalopathy
* dementia
* pregnant or lactating women
* extreme pain or immobility

Primary outcomes:
measure: Blood Pressure in mmHg
timeFrame: 10months
Secondary outcomes:
measure: Attention in TAP
timeFrame: 10months
measure: Orthostatic symptoms (Winkler Scale)
timeFrame: 10months
measure: daytime sleepiness
timeFrame: 10months
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: University Hospital, RWTH Aachen
state: NRW
Study officials:
affiliation: Universitiy hospital RWTH Aachen, Department of Neurology
name: Andrea Maier, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Husch S, Schauermann J, Fimm B, Haubrich C, Reetz K, Schulz JB, Maier A. Effect of strength training on orthostatic hypotension in Parkinson's disease-a pilot study. Clin Auton Res. 2022 Jun;32(3):213-217. doi: 10.1007/s10286-022-00870-5. Epub 2022 Jun 15. No abstract available.
Clinical trial NCT04544800: Development of Upper Aerodigestive Tract Splint
Official title: Development of Upper Aerodigestive Tract Splint
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Splints
Keywords: Upper Aerodigestive Tract
Visualization
Surgical Instrumentation
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2020-09-10
Enrollment: 7
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The study hypothesis is that a splint will improve access to the upper aerodigestive tract (UADT) for diagnosis and treatment.

Detailed description: This is a pilot study of 30 patients. We will tabulate the data for efficacy, there will be no statistical analysis.

Eligibility criteria: Inclusion Criteria:

* Require a procedure involving the upper aerodigestive tract (UADT)

Exclusion Criteria:

* Prior surgery to tongue or mouth that precludes the use of the splint
* Trismus with mouth opening that does not allow for use of the splint
* TMJ dysfunction that precludes the use of the splint
* Allergy to local anesthetic

Primary outcomes:
measure: Patient Splint Satisfaction Questionnaire
timeFrame: Immediately after the intervention/procedure/surgery
measure: Physician Splint Satisfaction Questionnaire
timeFrame: Immediately after the intervention/procedure/surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Douglas B Chepeha, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02588300: Upper Airway Collapse in Patients With Obstructive Sleep Apnea Syndrome by Drug Induced Sleep Endoscopy
Official title: Evaluation of the Upper Airway Collapse in Patients With Obstructive Sleep Apnea Syndrome by Drug Induced Sleep Endoscopy According to the Munich Sleep Video Protocol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Apnea Syndrome
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2015-10-27
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a prospective, interventional cohort study of drug-induced sleep endoscopy (DISE). The goal is to evaluate the upper airway in a cohort of patients with obstructive sleep apnea hypopnea syndrome (OSAHS) diagnosed in a prior polysomnography.

This study correlates the sedation level measured by entropy during DISE using propofol via a TCI pump with the local obstruction patterns of the upper airway according to the VOTE classification.

As OSAHS is a widespread disease and the DISE procedure has become a common tool for diagnosis and evaluation of further treatment, a growing number of research articles deal with this topic. These articles are available through pubmed.


Eligibility criteria: Inclusion Criteria:

* documented sleep apnea Syndrome with an AHI \> 5 diagnosed by polysomnography

Exclusion Criteria:

* active infection
* performed oral, head or neck surgery, pregnancy,
* ASA classification III or higher,
* chronic use of alcohol, sedatives or illicit drugs and chronic
* obstructive pulmonary disease.

Primary outcomes:
measure: collapse of the upper airway according to the VOTE classification
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Klinik für Anaesthesiologie
state: Bayern
Study officials:
affiliation: Klinikum rechts der Isar
name: Guenther Edenharter, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Heiser C, Fthenakis P, Hapfelmeier A, Berger S, Hofauer B, Hohenhorst W, Kochs EF, Wagner KJ, Edenharter GM. Drug-induced sleep endoscopy with target-controlled infusion using propofol and monitored depth of sedation to determine treatment strategies in obstructive sleep apnea. Sleep Breath. 2017 Sep;21(3):737-744. doi: 10.1007/s11325-017-1491-8. Epub 2017 Mar 31.
Clinical trial NCT00330200: Effects of ISIS 113715 on Insulin Sensitivity, Glucose, and Lipid Metabolism and Energy Expenditure in Type 2 Diabetics
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Examine the Effects of ISIS 113715 Monotherapy on Insulin Sensitivity, Glucose and Lipid Metabolism and Energy Expenditure in Subjects With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Type 2 Diabetes Mellitus
Keywords: Fasting plasma glucose
HbA1c
Metabolism
Lead sponsor: Ionis Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2006-05-26
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to examine the effects of ISIS 113715 monotherapy on insulin sensitivity, glucose and lipid metabolism and energy expenditure in subjects with type 2 diabetes mellitus.


Eligibility criteria: Inclusion Criteria:

* Male or female (post menopausal and/or surgically sterile)
* Aged 18 to 70 years
* Treatment naïve subjects with fasting blood glucose levels of 150-220 mg/dL, hematocrit of \>/= 35% and HbA1c levels of \>/= 7% and \</= 10.0%
* Subjects on antidiabetic therapy with fasting blood glucose levels of 100-200 mg/dL, hematocrit of \>/= 35%, and HbA1c levels of \>/= 6.5% and \</= 9.0%

Exclusion Criteria:

* Greater than 3 severe hypoglycemic episodes within six months of screen
* Pregnant, breastfeeding, or intends to become pregnant
* Clinical signs or symptoms of liver disease, acute or chronic hepatitis, or ALT greater than 1.5 times the upper limit of normal
* History of hepatitis B surface antigen, hepatitis C antibody, or HIV
* Complications of diabetes (e.g., neuropathy, nephropathy, and retinopathy)
* Clinically significant and currently active diseases
* Clinically significant abnormalities in medical history, physical examination, or laboratory examination

Primary outcomes:
measure: Evaluate the effects of ISIS 113715 on hepatic and peripheral insulin sensitivity
measure: Examine the effect on whole body energy expenditure
measure: Evaluate the effects on fasting and postprandial glucose excursions
measure: Evaluate the effects on hemoglobin A1c (HbA1c)
Secondary outcomes:
measure: Expand the safety and tolerability profile for ISIS 113715
measure: Assess the effects of ISIS 113715 on rates of basal and insulin stimulated whole body glycerol turnover
measure: Assess the effects of ISIS 113715 on insulin suppression of local rates of lipolysis (microdialysis)
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale - New Haven Hospital
state: Connecticut
Study officials:
affiliation: Ionis Pharmaceuticals, Inc.
name: Isis Pharmaceuticals
role: STUDY_CHAIR
References:
Clinical trial NCT04583800: Prediction of Heart Failure and Cognitive Decline in Type 2 Diabetes
Official title: Prediction of Heart Failure and Cognitive Decline in Type 2 Diabetes : Longitudinal Cohort Study of Immuno-inflammation, Cardiac Energetics and Cognition.PreciDIAB-HEART&BRAIN
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes Mellitus, Type 2
Heart Failure
Cognitive Decline
Keywords: Dementia
Stroke Prevention
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2020-10-12
Enrollment: 600
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: People with type 2 diabetes and free of heart failure (≥stade B).

Brief summary: Type 2 diabetes is a risk factor of heart failure and cognitive decline. Heart failure at its early stage is often silent. At present, primary prevention for heart failure is not available. Our aim is to identify diabetic patients at risk of heart failure in order to develop personalized preventive strategies.

Type 2 diabetes is vascular and metabolic risk factor for cognitive decline though a direct lesional effect but also through an interaction with underlying neurodegenerative lesions. Our aim is to identify diabetic patients at risk of cognitive decline in order to develop personalized preventive strategies


Eligibility criteria: Inclusion Criteria:

* Adults
* Persons able to understand and object to the information provided.
* Type 2 diabetic patient free of heart failure ≥stade B
* Patient affiliated with a social security scheme.
* Patient agreeing to sign the informed consent form

Exclusion Criteria:

* Patient with dementia
* Patient with at least one of the criteria for heart failure ≥stade B

Primary outcomes:
measure: Heart failure (≥ stade B).
timeFrame: at 48 months
Secondary outcomes:
measure: Cognitive decline (composite endpoint)
timeFrame: at 48 months
measure: Major cardio-neuro-vascular events
timeFrame: at 48 months
Other outcomes:
Locations:
city: Lille
country: France
facility: Hopital Roger Salengro, CHU Lille
Study officials:
affiliation: University Hospital, Lille
name: Charlotte Cordonnier, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01497600: Pharmacokinetics of Insulin Detemir in Subjects With Type 2 Diabetes
Official title: A Randomised, Double-blind, Six-period, Cross-over, Dose-response Trial Investigating the Pharmacodynamics and Pharmacokinetics of Single Doses of Insulin Detemir and NPH Insulin in Subjects of Blacks or African American, Whites of Hispanic or Latino Origin and Whites Not of Hispanic or Latino Origin With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2011-12-22
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in the United States of America (USA). The aim of this trial is to evaluate the the dose-response of insulin detemir and insulin NPH in subjects with type 2 diabetes of various race and ethnicity.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes
* Insulin treatment with any insulin preparation/regimen for at least three months with or without combination with below or equal to 2 oral antidiabetic agents (OADs)
* Duration of diabetes at least 12 months
* Body Mass Index (BMI) below 33 kg/m\^2
* HbA1c maximum 10 % based on analysis from the central laboratory

Exclusion Criteria:

* Current treatment with insulin above 1.2 U/kg/day
* Current treatment with drugs known to interfere with glucose metabolism other than OADs such as systemic corticosteroids, non-selective beta-blockers, and monoamino oxidase (MAO) inhibitors
* Blood donation of more than 500 mL within the last three months

Primary outcomes:
measure: Area under the glucose infusion rate curve
Secondary outcomes:
measure: Maximum glucose infusion rate
measure: Time to maximum glucose infusion rate.
measure: Area under the serum insulin curve
measure: Maximum serum insulin concentration
measure: Time to maximum insulin concentration
measure: Terminal rate constant of insulin
measure: Terminal half-life of insulin
measure: Adverse events
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: Novo Nordisk Investigational Site
state: California
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Hompesch M, Troupin B, Heise T, Elbroend B, Endahl L, Haahr H, Heinemann L. Time-action profile of insulin detemir and NPH insulin in patients with type 2 diabetes from different ethnic groups. Diabetes Obes Metab. 2006 Sep;8(5):568-73. doi: 10.1111/j.1463-1326.2006.00643.x.
Clinical trial NCT00260000: Study of BH4, a New and Simple Treatment of Mild PKU
Official title: Study of the Response of Tetrahydrobiopterin on S-Phenylalanine in Patients With PKU Housing the Y414C Mutation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Phenylketonuria
Keywords: mild PKU
Y414C
5,6,7,8-tetrahydrobiopterin, BH4
treatment without protein restriction
Lead sponsor: The Kennedy Institute-National Eye Clinic
Sponsor class: OTHER_GOV
Collaborators: name: Sygekassernes Helsefond
First posted: 2005-12-01
Enrollment: 15
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The main purpose is to test whether treatment with BH4-tablets can replace the protein restrictive diet in patients with mild PKU caused by a certain frequent mutation.

Detailed description: PKU, phenylketonuria, is a rare, inherited metabolic disorder that results in mental retardation if not a very strict low-protein diet is started within the first weeks of life.

The conversion of phenylalanine, phe, to tyrosine is defect, phe accumulates, leading to brain damage. There are different degrees of severity, reflecting the spectrum of mutant genes. BH4, tetrahydrobiopterin, is a co-enzym for the conversion of phe to tyrosine. It is known that BH4 can lower phe in some patients with milder forms of PKU.

The main purpose is to test whether treatment with oral BH4 can replace the protein restrictive diet in patients with mild PKU caused by the frequent mutation Y414C in the phenylalanine hydroxylase gene.

Eligibility criteria: Inclusion Criteria:

Diagnosed mild PKU with 2 known mutations in the PAH gene, hereof at least one Y414C From the age of eight Informed consent -

Exclusion Criteria:

Less than 8 years of age Pregnancy or treated with the intensive diet of pregnancy

-

Primary outcomes:
measure: Fasting S-phenylalanine at day 0, 1, 2, 5, 7 in each week of treatment with BH4.
Secondary outcomes:
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: The Kennedy Institute-National Eye Clinic
state: Copenhagen
Study officials:
affiliation: The Kennedy Institute-National Eye Clinic
name: Jytte B Nielsen, DMSc
role: PRINCIPAL_INVESTIGATOR
References: