louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00748059: The Pathophysiology of Orthostatic Hypotension
Official title: The Pathophysiology of Orthostatic Hypotension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Autonomic Nervous System Diseases
Orthostatic Hypotension
Dopamine Beta-Hydroxylase Deficiency
Orthostatic Intolerance
Keywords: autonomic nervous system diseases
blood pressure
congenital
orthostasis
catecholamines
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2008-09-08
Enrollment: 10
Sex: ALL
Minimum age (years): 12
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The purpose of this study is to determine the cause of low blood pressure in selective patients who have problems with their involuntary (autonomic) nervous system. These patients frequently have had symptoms throughout their life, and their disorder might have a genetic basis. The biochemical, physiological and pharmacological procedures in this study should help us define the problem and perhaps lead to more effective treatment.


Eligibility criteria: Inclusion Criteria:

* severe orthostatic hypotension and other autonomic symptoms but do not meet criteria for standard diagnosis
* non-smokers
* drug-free
* able to give informed consent
* free of pulmonary, renal, hematopoietic, hepatic and cardiac disease

Exclusion Criteria:

* medications affecting the autonomic nervous system
* any chronic illness
* anemia (Hct\<30)
* women of childbearing age who are pregnant or nursing
* smokers

Primary outcomes:
measure: hemodynamic changes with standing
timeFrame: following test
Secondary outcomes:
measure: blood and urine hormones
timeFrame: after test
measure: blood volume
timeFrame: during supine and/or upright postures
measure: sympathetic nerve activity
timeFrame: during stimulation of sympathetic nervous system
measure: quantitative sweat testing
timeFrame: 2 hours
measure: Eye function
timeFrame: once
measure: Sleep efficiency
timeFrame: once
measure: Metabolic rate
timeFrame: once
measure: Pain response
timeFrame: once
measure: Responses on questionnaires and computer tasks designed to assess brain function
timeFrame: once
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: Emily M Garland, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Arnold AC, Garland EM, Celedonio JE, Raj SR, Abumrad NN, Biaggioni I, Robertson D, Luther JM, Shibao CA. Hyperinsulinemia and Insulin Resistance in Dopamine beta-Hydroxylase Deficiency. J Clin Endocrinol Metab. 2017 Jan 1;102(1):10-14. doi: 10.1210/jc.2016-3274.
Clinical trial NCT02101359: Efficacy and Safety Assessment of Intracameral Injection of T2380 in Cataract Surgery
Official title: Efficacy and Safety Assessment of Intracameral Injection of T2380 in Cataract Surgery Versus Reference Group (Topical Mydriatics and Anaesthetic)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cataract
Lead sponsor: Laboratoires Thea
Sponsor class: INDUSTRY
First posted: 2014-04-02
Enrollment: 609
Sex: ALL
Minimum age (years): 40
Maximum age (years): 88
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the efficacy and safety assessment of T2380 for mydriasis and anaesthesia in phacoemulsification cataract surgery versus reference group (topical mydriatics and anaesthetic) 2X246 patients.

Detailed description: In order to perform pupil size measurements and ocular discomfort assessments at specific times, the surgical procedure was divided into 5 time periods according to the following time points: T1 (just before first incision), T2 (just before viscoelastic injection), T3 (just before capsulorhexis), T4 (just before intraocular lens injection), and T5 (just before cefuroxime injection).

Eligibility criteria: Inclusion Criteria:

* Signed and dated informed consent
* Male or female aged from 40 to 88 years old
* Scheduled to undergo unilateral cataract surgery

Exclusion criteria:

* Combined surgery
* Previous intraocular surgery

Primary outcomes:
measure: The Primary Efficacy Variable is Response Based on the Realisation of the Capsulorhexis Without Use of Any Additive Mydriatic Treatment.
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Clermont- Ferrand
country: France
facility: Laboratoires Thea
Study officials:
name: Joseph COLIN
role: PRINCIPAL_INVESTIGATOR
name: Marc LABETOULLE
role: PRINCIPAL_INVESTIGATOR
References:
citation: Labetoulle M, Behndig A, Tassignon MJ, Nuijts R, Mencucci R, Guell JL, Pleyer U, Szaflik J, Rosen P, Berard A, Chiambaretta F, Cochener-Lamard B; Intracameral Mydrane (ICMA), Ethics Group. Safety and efficacy of a standardized intracameral combination of mydriatics and anesthetic for cataract surgery in type-2 diabetic patients. BMC Ophthalmol. 2020 Mar 3;20(1):81. doi: 10.1186/s12886-020-01343-x.
citation: Labetoulle M, Findl O, Malecaze F, Alio J, Cochener B, Lobo C, Lazreg S, Hartani D, Colin J, Tassignon MJ, Behndig A; Intracameral Mydrane Study 2 Group. Evaluation of the efficacy and safety of a standardised intracameral combination of mydriatics and anaesthetics for cataract surgery. Br J Ophthalmol. 2016 Jul;100(7):976-985. doi: 10.1136/bjophthalmol-2015-307587. Epub 2015 Nov 3.
Clinical trial NCT03654859: Silesian Registry of Out-of-Hospital Cardiac Arrests
Official title: Silesian Registry of Out-of-Hospital Cardiac Arrests
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Out-Of-Hospital Cardiac Arrest
Keywords: OHCA
cardiac arrest
cardiopulmonary resuscitation
Lead sponsor: Silesian Centre for Heart Diseases
Sponsor class: OTHER
Collaborators: name: Voivodeship Rescue Service in Katowice
First posted: 2018-08-31
Enrollment: 1560
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The area covered by the registry is a part of Silesian Voivodeship, Poland, which is the region of activity of Voivodeship Rescue Service in Katowice. There are 2,700,000 inhabitants in the area covered by the registry. All cases of out-of-hospital cardiac arrest with cardiopulmonary resuscitation started or continued by emergency medical services of Voivodeship Rescue Service in Katowice, as well as cases in which resuscitation is not attempted will be included.

Brief summary: Silesian Registry of Out-of-Hospital Cardiac Arrests (SIL-OHCA) which is an initiative of the Voivodeship Rescue Service in Katowice in cooperation with the Silesian Center for Heart Diseases in Zabrze is a prospective, population-based registry of out-of-hospital cardiac arrests (OHCA). The main aim of the SIL-OHCA is to asses the frequency of OHCA in the population of Upper Silesia and analyze prognostic factors for long-term survival in patients with OHCA.


Eligibility criteria: Inclusion Criteria:

* Out-of-hospital cardiac arrest treated by emergency medical services of Voivodeship Rescue Service in Katowice.

Exclusion Criteria:

* none

Primary outcomes:
measure: All-cause mortality
timeFrame: 12 months
Secondary outcomes:
measure: 30-day survival or survival to discharge
timeFrame: 30 days
measure: Any return of spontaneous circulation
timeFrame: from OHCA until transfer to the hospital or decision to withdraw CPR (assessed up to 24 hours after OHCA)
measure: Event survival
timeFrame: within first 24 hours after OHCA
Other outcomes:
Locations:
city: Katowice
country: Poland
facility: Voivodeship Rescue Service
Study officials:
References:
Clinical trial NCT00774059: Evaluation of Safety and Performance of the Orbix Breast Lift System
Official title: Phase 1 Study to Evaluate the Safety and Performance of the Orbix Breast Lift System
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Breast Ptosis
Keywords: Breast ptosis, Breast lift
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2008-10-16
Enrollment: 0
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study is using a new breast lift system to complement a breast-lift operation.

In general there will be recurrence of breast-ptosis after a correcting operation.

With this device we want to minimize this recurrence and provide an "internal bra".


Eligibility criteria: Inclusion Criteria:

1.Female subject between 30-50 years of age 2. Subject is referred for mastopexy(breast lifting)due to one of the following reasons:

* Breast ptosis grade I or II (minimal invasive)
* Breast ptosis grade I to IV (open procedure)
* pseudoptosis following breast reduction surgery 3. subject willing to participate as evidenced by signing the written informed consent 4. Minimal invasive: breast cup size \<C

Exclusion Criteria:

1. Pregnant or lactating women
2. history of surgical procedures involving the ribs and rib cage
3. Osteoporosis
4. breast implants
5. breast carcinoma
6. auto-immune disease -

Primary outcomes:
measure: Result after using the breast lift system,recurrence of ptosis.
timeFrame: one year
Secondary outcomes:
measure: complications
timeFrame: one year
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht Univeristy Hospital
Study officials:
affiliation: Maastricht University Hospital
name: Marjoes MP Schuckman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Orbix medical
name: Adi Cohen
role: STUDY_DIRECTOR
References:
Clinical trial NCT06421259: Descriptive Analysis of Changes in Hepatitis B Markers in People Living With HIV on Injectable Therapy.
Official title: To Switch or Not to Switch to CAB/RPV in PLWH With Past HBV Infection? Risk of HBV Reactivation? A Need for New HBV Markers?
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Hiv Infection
Hepatitis B
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2024-05-20
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: HIV infected patients attending care in the infectiious disease department of the Universitary Hospital of Nice

Brief summary: In order to assess the risk of hepatitis B reactivation in people living with HIV and undergoing injection therapy, we propose to carry out a descriptive analysis of the evolution of hepatitis B markers in this population.


Eligibility criteria: Inclusion Criteria:

-HIV infected patients under injectable ART

Exclusion Criteria:

-Active HBV infection

Primary outcomes:
measure: Risk of HBV reactivation under injectable HIV ART
timeFrame: From start of injectable HIV treatment to hepatitis B reactivation, assessed up to 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU NiICE
state: Alpes Maritimes
Study officials:
affiliation: Centre Hospitalier Universitaire de Nice
name: Alissa NAQVI
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01823159: Cortical Excitability Changes Induced by Retigabine: a Transcranial Magnetic Stimulation Study
Official title: Cortical Excitability Changes Induced by Retigabine: a Transcranial Magnetic Stimulation Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Epilepsy
Keywords: retigabine
cortical excitability
Transcranial Magnetic Stimulation
Lead sponsor: University Hospital of Mont-Godinne
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
name: Université Catholique de Louvain
First posted: 2013-04-04
Enrollment: 15
Sex: ALL
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: The objective of this study is to characterize the effects of a single-dose of retigabine on cortical excitability in healthy subjects, as quantified by means of TMS.

Detailed description: Epilepsy is a disorder of brain excitability. Antiepileptic drugs (AEDs) modulate this excitability and transcranial magnetic stimulation (TMS) imposed itself as one of the best noninvasive methods to study cortical excitability in human subjects.

Based on several recent studies, we hypothesize that measuring TMS parameters in the patients suffering from epilepsy can rapidly predict the effectiveness of the newly given AED and, ultimately, guide the optimization of the AED therapy. Characterizing the neurophysiological properties of innovative AEDs such as retigabine with TMS will allow 1) to better understand how AEDs modulate, in vivo, cortical excitability in humans in relation to their mode of action and 2) to establish TMS as a tool for assessing individual responsiveness to a particular AED treatment and for antiepileptic treatment monitoring.

The effects of most AEDs on cortical excitability have been investigated. The modifications of the excitability parameters are related to the specific mode of action of each AED. For the new AED retigabine, at least two modes of action are known: 1) increase in cellular potassium efflux by changing conformation of the KV7.2-7.3 channels and 2) enhancement of GABA-A activity.

Eligibility criteria: Inclusion Criteria:

* age 18-50 years
* being "healthy"
* willing to participate and able to understand study and provide informed consent

Exclusion Criteria:

* intake of psycho-active drugs (AEDS, antidepressants, benzodiazepines, neuroleptics, hypnotics, ...)
* alcohol or drug abuse
* antecedent of seizure
* contra-indication to TMS (metal in the head, skull fracture)
* contra-indication to retigabine.

Primary outcomes:
measure: Measurement of TMS cortical excitability parameter before and after drug intake
timeFrame: Two hours after oral intake
Secondary outcomes:
measure: Assessing tolerability of a single dose intake of retigabine
timeFrame: 24 hours after drug intake
Other outcomes:
Locations:
city: Yvoir
country: Belgium
facility: CHU Mont-Godinne
state: Namur
Study officials:
affiliation: CHU Mont-Godinne
name: Michel Ossemann, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05470959: Bioactive Composite Versus Resin-Modified Glass Ionomer Liners: 2-Year Clinical Trial
Official title: Bioactive Ionic Resin Composite Versus Resin-Modified Glass Ionomer Cavity Liners: 2-Year Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2022-07-22
Enrollment: 20
Sex: ALL
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: compare 2-year clinical performance of recent bioactive ionic resin composite to resin-modified glass ionomer liner in indirect dental pulp treatment.

Detailed description: patients were enrolled in the clinical trial. Each patient had two deep carious lesions, one on each side of the mouth. After selective caries removal, cavities were lined with bioactive ionic resin composite (Activa Bioactive Liner/Base) or resin-modified glass ionomer liner (Riva Light Cure RMGI). All cavities were then restored with nanofilled resin composite (Filtek Z350xt). All materials were placed according to the manufacturers' instructions. Clinical evaluation was accomplished using World Dental Federation (FDI) criteria at baseline and after 6 months, one year, one and half years, and two years.

Eligibility criteria: Inclusion Criteria:

* presence of two deep carious lesions, one on each side of the mouth (ICDAS 5 or 6)
* vital teeth
* no sensitivity to teeth percussion
* no spontaneous pain
* no radiolucency in the periapical or furcation area of teeth
* complete and normal occlusion
* good oral hygiene

Exclusion Criteria:

* poor oral hygiene
* severe or chronic periodontal problems
* periapical lesions
* heavy bruxism
* non-vital teeth
* visibly cracked teeth
* spontaneous dental pain
* sensitivity to teeth percussion

Primary outcomes:
measure: assess clinical performance of bioactive ionic resin composite and resin-modified glass ionomer liner by using FDI clinical criteria
timeFrame: 2-years
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Faculty of Dentistry
Study officials:
affiliation: faculty of dentistry, mansoura university
name: salah mahmoud, professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05712759: Nosocomial Influenza Surveillance of 2022 - 2027 Seasonal Period
Official title: Surveillance of Nosocomial Influenza at Edouard Herriot University Hospital, Lyon, France
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Infection Viral
Keywords: influenza
hospital
nosocomial
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2023-02-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any volunteer adult patient (≥ 18 years of age) hospitalized at Edouard Herriot Hospital for at least 24 hours on a study unit, who had a nasopharyngeal swab taken as part of care for the purpose of diagnosing influenza by PCR testing and who had an influenza-like illness meeting the following definition

Brief summary: Hospital-Acquired Influenza (HAI) is closely linked to the intensity of influenza in the community. HAI is associated with significant morbidity, mortality and extra costs due to prolonged hospital stay. The incidence of laboratory confirmed HAI has been reported rarely. The proportion of HAI among influenza cases was 11.38% (95% Confidence Interval: 5.19%-19.55%) in a meta-analysis of 14 studies. In France, a prospective surveillance study of adults with Influenza-Like Illness (ILI) over 11 years, reported that 35.6% of the influenza cases diagnosed at hospital were hospital-acquired.

HAI is transmitted via respiratory droplets and by hand contacts. The spread is facilitated by Health Care Professionals (HCPs), patients and visitors.

Prevention and control of HAI is of upmost importance to preserve patient safety and limit the related economic costs. While vaccination of HCPs has been shown to contribute to the reduction of HAI, less is known on the impact of patient vaccination on the risk of HAI during hospitalization.

The aim of this study is to describe the hospital-acquired influenza in a french university hospital.


Eligibility criteria: Inclusion Criteria:

* Any volunteer adult patient (≥ 18 years of age) hospitalized for at least 24 hours on a study unit, who had a nasopharyngeal swab taken as part of care for the purpose of diagnosing influenza by PCR testing and who had an influenza-like illness meeting the following definition:
* Fever greater than 37.8°C in the absence of antipyretics; And/or
* Cough or pharyngeal pain.

Exclusion Criteria:

* Any person who does not meet the above definition or who has expressed opposition.

Primary outcomes:
measure: To describe and document cases of nosocomial influenza occurring at Edouard Herriot Hospital.
timeFrame: At inclusion
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00529659: A Study of the Safety and Efficacy of MK-0773 in Women With Sarcopenia (Loss of Muscle Mass)(MK-0773-005)
Official title: A Phase IIa Randomized, Placebo-Controlled Clinical Trial to Study the Efficacy and Safety of MK-0773 in Patients With Sarcopenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Sarcopenia
Keywords: Sarcopenia (loss of muscle mass)
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-09-14
Enrollment: 170
Sex: FEMALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A study to evaluate the safety, tolerability, and efficacy of MK-0773 in women with sarcopenia (loss of muscle mass).


Eligibility criteria: Inclusion Criteria:

* Patient is a woman who is 65 years of age or older
* Patient's lean body mass is at least 1 standard deviation below the mean of a healthy young adult population
* Patient has difficulty climbing 10 steps or walking outside on level ground for 1/4 mile without resting or Activity Measure for Post Acute Care (AM-PAC)\<66

Exclusion Criteria:

* Patient has serious neurological, rheumatologic, cardiac, respiratory, kidney, psychiatric conditions
* Patient has a history of certain types of cancer

Primary outcomes:
measure: Change From Baseline in Participant Lean Body Mass
timeFrame: Baseline, Month 6
measure: Change From Baseline in Bilateral Leg Press (BLP) Measurement
timeFrame: Baseline, Month 6
Secondary outcomes:
measure: Change From Baseline in Participant Short Physical Performance Battery (SPPB)
timeFrame: Baseline, Month 6
measure: Change From Baseline in Participant Gait Speed
timeFrame: Baseline, Month 6
measure: Change From Baseline in Stair Climbing Power
timeFrame: Baseline, Month 6
measure: Change From Baseline in Activity Measure for Post Acute Care (AM-PAC) Physical Movement Score
timeFrame: Baseline, Month 6
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Papanicolaou DA, Ather SN, Zhu H, Zhou Y, Lutkiewicz J, Scott BB, Chandler J. A phase IIA randomized, placebo-controlled clinical trial to study the efficacy and safety of the selective androgen receptor modulator (SARM), MK-0773 in female participants with sarcopenia. J Nutr Health Aging. 2013;17(6):533-43. doi: 10.1007/s12603-013-0335-x.
Clinical trial NCT01492959: Observational Study With InnoLet® in Daily Clinical Practice
Official title: A Prospective, Open, Uncontrolled, Observational Study With Innolet in Daily Clinical Situations According to the Product Labelling, Without Any Study Specific Investigations
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2011-12-15
Enrollment: 1030
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Korean patients with diabetes mellitus in need of insulin treatment

Brief summary: This study is conducted in Asia. The aim of this study is to review the efficacy and safety of insulin treatment with InnoLet® in daily clinical practice.


Eligibility criteria: Inclusion Criteria:

* Diabetes mellitus (Type 1 or type 2)
* Need insulin treatment

Primary outcomes:
measure: Change in HbA1c (glycosylated haemoglobin)
Secondary outcomes:
measure: Adverse events: Serious and non-serious
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References: