louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00293046: Assessment of Grazax® Treatment Compliance
Official title: A Randomised, Parallel-Group, Open, Controlled Phase III Trial Assessing the Treatment Compliance With GRAZAX® in Subjects With Seasonal Grass Pollen Induced Rhinoconjunctivitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Allergy
Keywords: Allergy
Lead sponsor: ALK-Abelló A/S
Sponsor class: INDUSTRY
First posted: 2006-02-17
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This trial is performed to assess whether the Grazax® treatment compliance can be improved by use of a compliance device (Memozax®).


Eligibility criteria: Inclusion Criteria:

* Grass pollen induced rhinoconjunctivitis
* Males and females, 18-65 years of age
* Positive skin prick test

Exclusion Criteria:

* Previous treatment with grass pollen allergen

Primary outcomes:
measure: Assessment of treatment compliance by recording of drug accountability
Secondary outcomes:
measure: Recording of adverse events
Other outcomes:
Locations:
city: Wien
country: Austria
facility: Allgergie - Ambulatorium Rennweg
Study officials:
affiliation: ALK-Abelló A/S
name: Kim Simonsen, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03752346: Multimodal Exercise Program on Parkinson's Disease Patients With Depression
Official title: Effectiveness of Multimodal Exercise Program on Depression and Health-Related Quality of Life in Patients With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Keywords: Parkinson's Disease
A Multimodal Exercise Program
Aerobic Exercise
Depression
Health Related Quality of Life
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2018-11-26
Enrollment: 98
Sex: ALL
Minimum age (years): 40
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Depression symptoms are common in Parkinson's Disease, it affects health-related quality of life. The evidence showed that exercise improved depression and HRQOL in PD patients. However, studies rarely considered the appropriate exercise program for PD patients, we want to find the best exercise program for PD patients.

Detailed description: Objective: Evaluate the effectiveness of a 8-week multimodal exercise program on depression and HRQOL in PD Patients.

Methods: Single-blinded, randomized controlled trial, from March 2016 to January 2017. Ninety-eight patients recruited to 2 groups: exercise group (n = 49) and control group (n = 49). The primary outcomes were depression and HRQOL; the secondary outcomes were activity of daily living, motor ability, fatigue, sleep quality and anxiety. Data collection at baseline, week 4 and 8 after intervention. Intervention were Multimodal Exercise Program, at least three times (30 - 50 minutes per section) a week or 10-15 minutes per section every day to accumulate 150 minutes a week for 8 weeks.

Eligibility criteria: Inclusion Criteria:

* be diagnosed PD in Hoehn and Yahr stage I-II22
* under stable medication treatment at least 3 months
* no disease limiting the patient's ability to perform the exercises

Exclusion Criteria:

* severe cardiovascular disorders
* neuromusculoskeletal disorder
* cognitive impairment
* recent participation in any physiotherapy or rehabilitation program
* have exercise regularly

Primary outcomes:
measure: GDS-15
timeFrame: 3 minutes
measure: PDQ-8
timeFrame: 3 minutes
Secondary outcomes:
measure: UPDRS part II (ADL)
timeFrame: 5 minutes
measure: UPDRS part III (motor ability)
timeFrame: 10 minutes
measure: Fatigue (FSS)
timeFrame: 5 minutes
measure: Sleep quality (PSQI)
timeFrame: 5 minutes
measure: Anxiety (HAS)
timeFrame: 3 minutes
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02733146: Histones and Free-plasma DNA After Cardiac Arrest
Official title: Histones and Free-plasma DNA in the Days Following the Cardiac Arrest
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Arrest
Hypothermia
Post Cardiac Arrest Syndrome
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2016-04-11
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cardiac arrest patients with a presumed cardiac origin, treated with targeted temperature management for 24 hours.

For comparison; 20 healthy individuals were used.

Brief summary: To evaluate the significance of free-plasma deoxyribonucleic acid (DNA) and plasma histones in cardiac arrest patients.


Eligibility criteria: Inclusion Criteria:

* Out of hospital cardiac arrest of presumed cardiac cause
* Return of spontaneous circulation (ROSC)
* Glasgow Coma Score \< 8
* Age \> 18 years and \< 80 years

Exclusion Criteria:

* \>60 minutes from the circulatory collapse to ROSC
* Time interval \> 4 hours from cardiac arrest to initiation of targeted temperature management
* Terminal illness
* Coagulation disorder
* Unwitnessed asystolia
* Cerebral performance category 3-4 before the cardiac arrest
* Severe persistent cardiogenic shock
* Pregnancy
* Persistent cardiogenic shock (systolic blood pressure \< 80 despite inotropic treatment)
* New apoplexy or intracerebral hemorrhage
* Lack of consent from the relatives
* Lack of consent from the general practitioner
* Lack of consent from the patient if he/she wakes up and is relevant

Primary outcomes:
measure: Plasma histones
timeFrame: Approximate 24 hours after cardiac arrest
measure: Free-plasma DNA
timeFrame: Approximate 24 hours after cardiac arrest
Secondary outcomes:
measure: Plasma histones
timeFrame: Approximate 48 hours and 72 hours after cardiac arrest
measure: Free-plasma DNA
timeFrame: Approximate 48 hours and 72 hours after cardiac arrest
Other outcomes:
measure: Simplified Acute Physiology Score (SAPS) score
timeFrame: Approximate 24 hours, 48 hours and 72 hours after cardiac arrest
measure: Platelet count
timeFrame: Approximate 24 hours, 48 hours and 72 hours after cardiac arrest
Locations:
city: Aarhus
country: Denmark
facility: Dept of Anesthesiology and Intensive Care and Dept of Clinical Biochemistry, Aarhus University Hospital
state: Aarhus N
Study officials:
References:
Clinical trial NCT00259246: The Role of Peptide YY (PYY)Infusions in Inhibiting Food Intake.
Official title: Fasting and Postprandial Response After Infusion of Saline, PYY1-36 and PYY3-36 and Effects on Appetite, Energy Intake and Energy Expenditure in Overweight/Obese Compared to Normalweight Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: EC-FP6 (contract number: LHM-CT-2003-503041)
name: Aditech Pharma AB
First posted: 2005-11-29
Enrollment: 24
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of the study is to compare fasting and postprandial PYY levels between overweight/obese and lean subjects during and after an infusion of saline, PYY1-36 or PYY3-36 and to evaluate the efects on appetite, energy intake and energy expenditure.

Detailed description: The study is a randomised dobbelblinded placebo controlled study with 24 male subjects ( 12 lean and 12 overweight/obese subjects). VAS scores are used to assess appetite and two ad libitum meals are served in the hours following the infusion. Energy expenditure is measured by ventilated hood system and blood is sampled during part of the study day.

Eligibility criteria: Inclusion Criteria:

* Normal weight (BMI: 18-23 kg/m2) or 12 overweight/obese (BMI: 27-40 kg/m2)
* Body weight fluctuations \< 5 kg over the past 2 months.
* Blood pressure normal to mildly hypertensive (\<159/99 mm Hg)
* Non-elite athletes and not planning to change physical activity during the study.

Exclusion Criteria:

* Any physiological or psychological illnesses that could influence the study results
* Regular use of medicine
* Smoking defined as \<1 cigarette per day.
* Substance abuse or dependence.
* Blood donation within the past 3 months before entering the study
* Drinking \>21 alcoholic units/week.
* Food allergies.
* Special diets (e.g. vegetarian) or dislikes to any of the foods served during the study.

Primary outcomes:
measure: Appetite
measure: Energy intake
Secondary outcomes:
measure: Energy expenditure and substrate oxidation
measure: Blood parameters
measure: Blood pressure and heart rate
Other outcomes:
Locations:
Study officials:
affiliation: Department of Human Nutrition, RVAU
name: Arne Astrup, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02864446: Intestinal Fatty Acid Binding Protein in Very Low Birth Weight Infants With Meconium Obstruction
Official title: The Clinical Utility of Urine Intestinal Fatty Acid Binding Protein in the Management of Very Low Birth Weight Infants With Meconium Obstruction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Meconium Obstruction of Prematurity
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2016-08-12
Enrollment: 100
Sex: ALL
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Preterm infants weighing \<1,250g who were admitted in neonatal intensive care unit at Seoul National University Children's Hospital

* Initial urine samples are collected at the time of 12, 24, 48 hours (+/- 6 hours) after birth.
* Further urine samples are collected every 48 hours when the enteral feeding starts. (till the amount of feeding reaches to 40mL/kg/day)

Brief summary: Urinary intestinal fatty acid binding protein (i-FABP), a marker of intestinal mucosal cell damage, has recently been proposed as a clinically useful measure in the early detection of necrotizing enterocolitis (NEC). However, there are no data on urinary i-FABP in meconium obstruction of prematurity (MOP). This study aimed to evaluate urinary i-FABP in MOP patient as a marker for early detection.


Eligibility criteria: Inclusion Criteria:

* preterm infants weighing \<1,250g

Exclusion Criteria:

* major congenital anomalies
* perinatal asphyxia (cord pH \<7.0)

Primary outcomes:
measure: Comparison of i-FABP level between the meconium obstruction group and the normal feeding advance group
timeFrame: within 48 hours after birth
Secondary outcomes:
Other outcomes:
measure: Comparison of i-FABP level between breast milk feeding and formular feeding in the normal feeding advance group
timeFrame: through study completion (an average of 1 month)
measure: Comparison of i-FABP level between preterm infants with small for gestational age and without small for gestational age in the normal feeding advance group
timeFrame: within 48 hours after birth
measure: Comparision of i-FABP level between preterm infants with chorioamnionitis and without chorioamnionitis in the normal feeding advance group
timeFrame: within 48 hours after birth
measure: Comparision of i-FABP level between preterm infants with maternal pregnancy induced hypertension (PIH) and without maternal PIH in the normal feeding advance group
timeFrame: within 48 hours after birth
measure: Comparison of i-FABP level between preterm infants with maternal premature rupture of membrane (PROM) and without PROM in the normal feeding advance group
timeFrame: within 48 hours after birth
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT00467246: Sub-Cutaneous Insulin in Hyperglycaemic Emergencies
Official title: The Use of a Long-Acting Sub-Cutaneous Insulin Analogue in the Management of Hyperglycaemic Emergencies
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Diabetes Mellitus
Keywords: Diabetes emergencies
Lead sponsor: The Royal Bournemouth Hospital
Sponsor class: OTHER
First posted: 2007-04-30
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: Hyperglycaemic emergencies are associated with significant mortality (mortality in Diabetic Ketoacidosis 0.65 - 3.3% and in HyperOsmolar Non-Ketotic Coma 12 -17%). To reduce morbidity and mortality, prompt intervention and coma and close monitoring are essential. The study is designed to investigate whether a simple intervention with a long acting insulin can improve resolution of acidosis and hyperglycaemia, prevent recurrence of ketoacidosis and shorten hospital stay.

Detailed description: This is a randomised trial concerning patients presenting in A \& E with a diabetic emergency, either a Diabetic Ketoacidosis (DKA) or a Hyperosmolar Non-Ketotic Coma (HONC). Once informed consent has been given, each patient will receive standard intravenous treatment. They will also receive a daily sub-cutaneous bolus of either a long-acting insulin or a placebo.

Blood will be taken at regular intervals to analyse the rate of fall of glucose and normalisation of blood pH.

Eligibility criteria: Inclusion Criteria:

* Patients presenting with a diabetic emergency aged 18 and above.

Exclusion Criteria:

* Patients who do not speak English and need a translator.
* Patients under the age of 18 years.
* Patients who are unable to give their consent and who do not have a relative present wiling to give assent.

Primary outcomes:
measure: Time to normoglycaemia
measure: Reduction of recurrence of ketoacidosis and hyperglycaemia.
Secondary outcomes:
measure: To investigate time to treatment in patients presenting with a hyperglycaemic emergency
Other outcomes:
Locations:
Study officials:
affiliation: Royal Bournemouth Hospital
name: David Kerr, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Royal Bournemouth Hospital
name: Martin Taylor, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01582646: Analgesic Effect of Beta 2-mimetics in the Treatment of Neuropathic Pain
Official title: Analgesic Effect of Beta 2-mimetics in the Treatment of Neuropathic Pain
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Postthoracotomy Pain
Postthoracoscopy Neuropathic Pain
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2012-04-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Neuropathic pain is due to a lesion or disease affecting the nervous system. Antidepressants (ADs) are recommended as the first line treatment. In a murine model, the investigators evidenced that antidepressants antiallodynic action is mediated through β2-adrenergic receptor stimulation and that β-mimetics display the same effect. These data support the idea that β-mimetics could offer a therapeutic alternative to ADs for neuropathic pain treatment. This study will aim at assessing the effects of terbutaline on neuropathic pain symptoms.


Eligibility criteria: Inclusion Criteria:

* adults from 18 to 75 years old
* neuropathic painful condition following a thoracotomy or thoracoscopy for at least 3 months

Exclusion criteria:

* cardiovascular risk
* unstable diabetes mellitus
* allergy for terbutaline
* hypokaliemia without treatment
* untreated hypothyroidism
* HIV- or chemotherapy-induced neuropathy
* cancer being treated by chemo- or radio-therapy
* concomitant treatment with β-blockers, tricyclic ADs or morphine
* concomitant pain more severe than neuropathic pain- pregnant women

Primary outcomes:
measure: Change from baseline in the average intensity of pain during the last 24 hours reported by the patient on a 11 points Numeric Scale
timeFrame: Day one, day 14 and day 28 of each 4 weeks period
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon,
country: France
facility: CHU de Besançon
city: Strasbourg
country: France
facility: Hôpitaux Universitaires de Strasbourg
Study officials:
affiliation: University Hospital, Strasbourg, France
name: André Muller, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02435446: Cone Beam and CT Scan for the Diagnosis of Otosclerosis (TACOS)
Official title: Comparison of Cone Beam With CT Scan for the Diagnosis of Otosclerosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Otosclerosis
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2015-05-06
Enrollment: 31
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: Computed tomography scan (CT) is routinely used for the diagnosis and the pre-operative assessment of otosclerosis.

The cone-beam computed tomography (CBCT) is a imaging technique with reduced irradiating and, therefore, could replace the CT.

In this study, a CBCT will be proposed to all patients undergoing a CT exam for the diagnosis and/or the pre-operative assessment of an otosclerosis.

The results of the CBCT will be compared to those of the CT scan.


Eligibility criteria: Inclusion Criteria:

* CT scan indicated for the diagnosis and pre-operatice assessment of an otosclerosis

Exclusion Criteria:

* Pregnancy
* Breast feeding
* Patient under a legal protection procedure
* Patient denying to participate to the study
* Lack of affiliation to a social security system

Primary outcomes:
measure: Sensitivity of the cone-beam computed tomography vs CT scan assessed by the presence or absence of areas of sclerosis
timeFrame: 1 minute
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation Ophtalmologique A de Rothschild
Study officials:
References:
Clinical trial NCT04333446: Circulating Levels of Pealbumin in Relation to Overweight or Obesity
Official title: Independent Relationship Between Prealbumin and Circulating Levels of Parathormone Triglycerides and FT3 in Subjects With Overweight or Obesity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Lead sponsor: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Sponsor class: OTHER
First posted: 2020-04-03
Enrollment: 84
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who came to the Outpatient Clinic of Nutrition at the National Institute of Gastroenterology "S. de Bellis," Research Hospital, Castellana Grotte, Italy.

Brief summary: The study was aimed to investigating the relationship between circulating level of prealbumin and parathormone (PTH), triglycerides and triiodothyronine (FT3) in overweight and obese subjects (BMI≥25 Kg/m2)


Eligibility criteria: Inclusion Criteria:

* Overweight or obesity (BMI\> 25 Kg/m2)

Exclusion Criteria:

* Any kind of drug Hypertension Endocrine diseases (diabetes mellitus, hypo or hyperthyroidism, hypopituitarism, etc.), Chronic inflammatory diseases Renal failure Liver failure Angina pectoris Myocardial infarction and heart failure Genetic heart diseases Thrombocytopenias

Primary outcomes:
measure: Prealbumin
timeFrame: baseline
measure: Free Triiodothyronine (FT3)
timeFrame: baseline
measure: Parathormone (PTH)
timeFrame: baseline
measure: Triglycerides
timeFrame: baseline
Secondary outcomes:
measure: Height
timeFrame: baseline
measure: Weight
timeFrame: baseline
measure: Body mass Index (BMI)
timeFrame: baseline
Other outcomes:
Locations:
city: Castellana Grotte
country: Italy
facility: Luisa Lampignano
Study officials:
References:
Clinical trial NCT02947646: Feasibility of BabyGentleStick- Adult Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lack of Adverse Events
Reduced Pain Response
Lead sponsor: Actuated Medical, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Milton S. Hershey Medical Center
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2016-10-28
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DEVICE_FEASIBILITY

Brief summary: This is a pilot, randomized, safety and efficacy study of an investigational device (i.e. BabyGentleStick™; BGS, Actuated Medical, Inc). The primary study objectives are to obtain subject feedback, assess device performance; and ascertain potential harm in healthy adult volunteers.


Eligibility criteria: Inclusion Criteria:

* Healthy adult volunteers 18-29 years of age.
* Fluent in written and spoken English
* Sex: male or female

Exclusion Criteria:

* Pregnant women
* Cognitive impairment
* Prisoner
* Individuals with known hematologic conditions or bleeding disorders
* Individuals with immune disorders where a finger lance puts them at risk for infection.

Primary outcomes:
measure: Number of Adverse Events
timeFrame: 24 hours after the intervention is received for each subject
Secondary outcomes:
measure: Reduced Pain Response
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Actuated Medical, Inc.
name: Ryan Clement, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: The Pennsylvania State University College of Medicine
name: Kim K Doheny, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: