louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05830409: Multisensory Stimulation in Infants for Eye Examination
Official title: Effect of Multisensory Stimulation on Pain During the Preterm Infant's Eye Examination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Premature Retinopathy
Pain, Eye
Keywords: preterm infants
Multisensorial stimulation
Lead sponsor: Akdeniz University
Sponsor class: OTHER
Collaborators: name: Burdur Mehmet Akif Ersoy University
First posted: 2023-04-26
Enrollment: 80
Sex: ALL
Minimum age (years): 32
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aimed to evaluate the effects of multisensory stimulation on pain and physiological parameters resulting from ROP examination in preterm newborns.

It was planned as a randomized controlled trial. trying to reach 80 newborns in total. Multisensory stimulation will be applied to the intervention group during the examination. In the control group, routine care will be applied during the examination.

Detailed description: Preterm retinopathy may develop due to intubation in preterm newborns. Therefore, this population undergoes eye examinations at regular intervals. This procedure is painful procedure for babies. Nurses can apply interventions to reduce this pain. In this study, it was planned to apply multisensory stimulation to reduce the pain of the newborn. A randomized controlled trial and routine care were planned in the control group. Neonatal pain will be assessed using the PIPP scale.

Eligibility criteria: Inclusion Criteria:

* According to the registry, premature neonates with a gestational age of ≤ 32 weeks or newborns with a birth weight of \< 1500 g.
* Newborns undergoing a first-time eye exam to screen for retinopathy of prematurity.

Exclusion Criteria:

* Newborns who need CPR during the examination.
* Newborns experience apnea during the examination.

Primary outcomes:
measure: Pain level
timeFrame: first 30 minutes during procedure
Secondary outcomes:
measure: Heart rate
timeFrame: first 30 minutes during procedure
measure: Oksigen saturation
timeFrame: first 30 minutes during procedure
Other outcomes:
Locations:
city: Antalya
country: Turkey
facility: Akdeniz University
Study officials:
affiliation: Burdur Mehmet Akif Ersoy University
name: Halil I Taşdemir, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02025309: Intraoperative Methylprednisolone and Sugammadex
Official title: Does Intraoperatively Administered Methylprednisolone Prolong the Neuromuscular Blocade Reversal Effect of Sugammadex?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Neuromuscular Monitoring
Sugammadex Effect
Keywords: train of four
neuromuscular recovery
sugammadex
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2014-01-01
Enrollment: 164
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: SCREENING

Brief summary: Sugammadex, a modified γ-cyclodextrin is a selective relaxant-binding agent that reverses the effects of steroidal neuromuscular blocking agents, rocuronium and vecuronium. It shows its activity by encapsulating these. Likewise, some other steroid hormones and drugs like flucloxacillin, toremifene, fusidic acid can also be effected. Thus, assuming that methylprednisolone would also be encapsulated by sugammadex and decrease its efficiency, in this study we aimed to compare the recovery times from recuronium-induced muscle relaxation after reversal with sugammadex between patients who receive intraoperative methylprednisolone or not.

After institutional review board (IRB) approval and informed consent, 100 patients will be enrolled in this prospective, single center, controlled study. Anaesthesia will be induced with propofol (3mg/kg) and rocuronium (0.6 mg/kg), followed by sevoflurane maintenance. Patients will be divided randomly into two groups methylprednisolone administered group and control group respectively). Neuromuscular blockade will be monitored using calibrated acceleromyography train-of-four (TOF WATCH SX Organon Ltd, Dublin, Ireland). Once rocuronium-induced neuromuscular blockade recovers spontaneously to TOF-count-two, all patients will receive 2.0 mg/kg of sugammadex. Neuromuscular monitoring will be continued until recovery of the TOF ratio to 0.9 at the ulnar nerve. The time to recovery of TOF to 0.9 will be compared in both groups. The statistical analyses will be performed using Student T Test and Mann-Whitney U test.


Eligibility criteria: Inclusion Criteria:

* patient operated under general anesthesia and endothracheal intubation.
* 18-65 years old
* ASA II

Exclusion Criteria:

* Neuromuscular desease
* Renal desease
* Liver failure
* Hypersensitivity to the medications used in the study.
* Being on steroid medication
* Pregnanacy, Lactation

Primary outcomes:
measure: Train of four ratio 0.9
timeFrame: During the procedure period.
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University Faculty of Medicine, Ibni Sina Hospital OR
Study officials:
affiliation: Ankara University Faculty of Medicine
name: Merve Hayriye Kocaoglu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03132909: Attitudes and Feelings of Doctors Caring for Their Colleagues: a Qualitative Study in Picardy
Official title: Attitudes and Feelings of Doctors Caring for Their Colleagues: a Qualitative Study in Picardy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Feelings
Attitude
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2017-04-28
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Doctors caring for their colleagues

Brief summary: The sick doctor is a patient apart. His right of prescription and his knowledge of semiology easily lead him to self-medication.

Detailed description: The sick doctor is a patient apart. His right of prescription and his knowledge of semiology easily lead him to self-medication. Several factors linked to his profession may also lead to a delay in care: overworking with schedules that are not compatible to organize follow-up, poor access to prevention or occupational medicine for liberal doctors but also modesty And ashamed of being sick (and especially unfit to heal). Specialized centers and specific training courses concerning burnout, addictions and psychiatric pathologies of doctors are currently emerging.

To look after a colleague also seems to imply certain specificities like the sharing of knowledge or the medical vocabulary. The physician-patient relationship may seem easier, but it can also lead to confusion of roles and create ambiguity. In this case, the doctor may feel too close to the doctor-patient to maintain his objectivity and to treat him properly. In the same way, the relationship of trust can be altered by sharing medical knowledge, communication techniques or confidence building which can thus lose their effectiveness.

This physician-caregiver relationship has already been the subject of some qualitative research demonstrating the difficulty from the point of view of the treated. The feelings and attitudes of the doctor caring for his colleague remains a field very little studied. The research hypothesis is that there are specificities to this relationship.

Eligibility criteria: Inclusion Criteria:

* Practicing general practitioners, registered with the Order, caring for or having treated other doctors whatever their specialties

Exclusion Criteria:

* No

Primary outcomes:
measure: Analyze the feelings of doctors who care for their colleagues through a questionnaire
timeFrame: 10 months
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens Picardie
state: Picardie
Study officials:
References:
Clinical trial NCT01939509: Hemodynamic Changes of Patients Receiving Atenolol/Bisoprolol
Official title: Comparison of the Hemodynamic Changes in Patients Under Treatment With Bisoprolol Versus Atenolol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Metabolic Syndrome
Lead sponsor: Hospital Italiano de Buenos Aires
Sponsor class: OTHER
First posted: 2013-09-11
Enrollment: 80
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: At hemodynamic level, the greater affinity of bisoprolol by the beta 1 receptor in theory could improve the peripheral arterial perfusion and could have a greater antihypertensive effect. At the same time, this could carry objectifiable improvements in the vascular tree, such as the level of arterial stiffness.

This study attempts to mark the hemodynamic differences in the same individual with hypertension and metabolic syndrome who will be exposed to both drugs at different moments. Parameters will be objectified with impedance cardiography, pulse wave velocity and central blood pressure assessment before and after taking each one of the drugs. The results will be compared to the baseline data and between themselves.


Eligibility criteria: Inclusion Criteria:

* Hypertension
* Metabolic syndrome

Exclusion Criteria:

* Severe hypertension \>180/110
* Secondary hypertension
* Contraindication for betablockers
* Prior treatment with betablockers (up to one month before inclusion)
* History of neoplastic disease
* Patients that do not sign informed consent

Primary outcomes:
measure: central blood pressure
timeFrame: two months
Secondary outcomes:
measure: peripheral resistance
timeFrame: two months
measure: cardiac index
timeFrame: two months
measure: pulse wave velocity
timeFrame: two months
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires
city: Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires
city: Buenos Aires
country: Argentina
facility: Hospital Italiano de Buenos Aires
Study officials:
affiliation: Hospital Italiano de Buenos Aires
name: Gabriel D Waisman, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00503009: Study Of RV-39 In Patients Who Also Have Asthma
Official title: An Exploratory Study to Evaluate the Response of Salmeterol Plus Fluticasone vs Fluticasone Alone to Experimental Nasal Inoculation With Rhinovirus
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Asthma
Keywords: Rhinovirus
Asthma
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-07-18
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will last up to 9 weeks. Subjects will visit the clinic up to 14 times. Certain clinic visits will include a physical examination, lung function tests, inflammatory cell analysis from nasal secretions and/or sputum, and blood draws. Subjects will inhale an FDA approved virus through their nose which is known to cause the common cold. All study related medications and medical examinations will be provided at no cost to the subject. The drugs used in this study are approved for the age group under study.


Eligibility criteria: Inclusion Criteria:

* Have asthma for at least 3 months prior to the study.
* Have been using an allowed pre-study asthma therapy for at least 3 months prior to study.
* Demonstrate airway hyperresponsiveness following inhalation of bronchoconstrictor.
* Have a positive allergic status antibody test.

Exclusion Criteria:

* Have a history of life-threatening asthma.
* Been hospitalized for asthma within the 24 months prior to the study.
* Have certain conditions that would make study participation unsafe.
* The study doctor will evaluate other inclusion and exclusion criteria.

Primary outcomes:
measure: Change From Baseline in the Cumulative Lower Respiratory Symptom Score Averaged Over Days 1-4
timeFrame: Days 1 through 4
Secondary outcomes:
measure: Change From Baseline in the Morning Peak Expiratory Flow (PEF) Averaged Over Days 1-4
timeFrame: Days 1 through 4
measure: Change From Baseline in the Morning Forced Expiratory Volume in One Second (FEV1) Averaged Over Days 1-4
timeFrame: Days 1 through 4
measure: Change From Baseline in Exhaled Nitric Oxide (eNO) Averaged Over Days 1-4
timeFrame: Days 1 through 4
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: GSK Investigational Site
state: Virginia
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT00340509: A Genome-Wide Scan For Quantitative Trait Loci of Serum Bilirubin - A Framingham Study
Official title: A Genome-Wide Scan For Quantitative Trait Loci of Serum Bilirubin - A Framingham Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Genetics
Keywords: Genetics
Population
CHD Risk
Epidemiology
Gene Mapping
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2006-06-21
Enrollment: 1888
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: Studies have shown that there is a significant association between serum bilirubin concentrations and risk of coronary artery disease (CAD). So far, no linkage analysis in humans between serum bilirubin and DNA markers has been reported. The purpose of this protocol is to identify chromosome regions that contain quantitative trait loci (QTL) involved in serum bilirubin metabolism and bilirubin concentration. In the Framingham Study, a 10cM genome scan (about 400 markers) has been conducted in more than three hundred families. Serum bilirubin was measured in the first and second exams of the Framingham Offspring. These data provide us the opportunity to undertake linkage analyses to map QTL of serum bilirubin.

Detailed description: Many studies showed that there is a significant relationship between serum bilirubin levels and risk of coronary artery disease (CAD). We carried out a genome-wide scan for quantitative trait loci of serum bilirubin through the 330 extended Framingham families and found significant evidence of linkage of serum bilirubin to chromosome 2q telomere where an important candidate gene, Uridine diphosphate glycosyltransferase 1 gene (UGT1A1), resides. The purposes of this protocol are to confirm linkage between serum bilirubin and UGT1A1, mathematical modeling and association studies between the genotypes of UGT1A1 and CAD.

Eligibility criteria: * INCLUSION CRITERIA:

The study population will include the members of the 330 Framingham Study families and 1888 random individuals.

The Original Cohort will also be included.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Heart, Lung and Blood Institute (NHLBI), 9000 Rockville Pike
state: Maryland
Study officials:
affiliation: National Heart, Lung, and Blood Institute (NHLBI)
name: Gang PH Zheng, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Djousse L, Levy D, Cupples LA, Evans JC, D'Agostino RB, Ellison RC. Total serum bilirubin and risk of cardiovascular disease in the Framingham offspring study. Am J Cardiol. 2001 May 15;87(10):1196-200; A4, 7. doi: 10.1016/s0002-9149(01)01494-1. No abstract available.
citation: Breimer LH, Wannamethee G, Ebrahim S, Shaper AG. Serum bilirubin and risk of ischemic heart disease in middle-aged British men. Clin Chem. 1995 Oct;41(10):1504-8.
citation: Almasy L, Blangero J. Multipoint quantitative-trait linkage analysis in general pedigrees. Am J Hum Genet. 1998 May;62(5):1198-211. doi: 10.1086/301844.
Clinical trial NCT03394807: LaGRA Trial in Laparoscopic Cholecystectomy
Official title: Laparoscopic Guided Regional Analgesia (LaGRA) Reduces Post Operative Pain After Laparoscopic Cholecystectomy - a Randomised, Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Regional Anesthesia Morbidity
Gallbladder Stone
Pain
Lead sponsor: Health Service Executive, Ireland
Sponsor class: OTHER
First posted: 2018-01-09
Enrollment: 76
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomised, placebo controlled trial
Primary purpose: TREATMENT

Brief summary: This study investigated the effectiveness of a surgeon administered, laparoscopic guided, regional anaesthesia technique.

Detailed description: A prospective, double blind, randomised controlled trial was performed. Consenting patients undergoing laparoscopic cholecystectomy were randomised, by envelope, to a laparoscopic guided 2-point blockade (subcostal transversus abdominis plane and rectus sheath) using either Chirocaine® 2.5mg/ml (LaGRA) or 0.9% Saline (Placebo) after specimen extraction.

Primary endpoints were post-operative pain in the first 6 hours. Secondary endpoints were analgesic/anti-emetic usage and day case and re-admission rates. Data was analysed using GraphPad Prism (V7).

Eligibility criteria: Inclusion Criteria:

* Patients undergoing laparoscopic cholecystectomy
* ASA I, II or III

Exclusion Criteria:

* Patients that don't consent to be included
* Allergy to levobupivacaine

Primary outcomes:
measure: Post operative pain score
timeFrame: 6 hours post operatively
Secondary outcomes:
measure: Opioid use
timeFrame: Perioperative period including first 6 hours post operatively
measure: Analgesic use
timeFrame: Perioperative period including first 6 hours post operatively
measure: Readmission rate
timeFrame: 30 days post operative
measure: Daycase rates
timeFrame: Day of surgery
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02010307: Polymorphonuclear Cells' Sensitivity to Aggregatibacter Actinomycetemcomitans Bacteria in Patients With Aggressive Periodontitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Periodontal Disease
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2013-12-12
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: aggressive periodontitis is an inflammatory disease which damage the teeth supporting structures mostly in young patients. and has genetic basis.

a specific bacteria: Aggregatibacter actinomycetemcomitans (Aa) is associated with this disease, and found to damage leukocytes by using a specific leukotoxin.

in the research the investigators are aiming to find molecular and immunological basis to aggressive periodontitis.


Eligibility criteria: Inclusion Criteria:

* patients in periodontal department
* healthy
* diagnosed with chronic/aggressive periodontal disease
* interested in participating the research

Exclusion Criteria:

* diagnosed with diabetes, heart disease, immunosuppression, thrombocytopenia, clotting enzyme deficiency.
* using alcohol, or drugs
* pregnancy

Primary outcomes:
measure: flow cytometry
timeFrame: 12 hours after blood extraction
Secondary outcomes:
measure: microscopy observation
timeFrame: 12 hours after blood extraction
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization, Jerusalem, Israel
Study officials:
affiliation: Haddasah Medical Center
name: David Polak, DMD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00758407: Methylphenidate Treatment of Cancer-Related Fatigue
Official title: Placebo Controlled Double Blind Study With Methylphenidate in Treatment of Adults With Cancer-Related Fatigue
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Cancer-related Fatigue
Keywords: Fatigue, Cancer, Methylphenidate,
Lead sponsor: Medice Arzneimittel Pütter GmbH & Co KG
Sponsor class: INDUSTRY
First posted: 2008-09-25
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this randomized controlled clinical trial is to investigate the efficacy and safety of methylphenidate in patients with fatigue caused by cancer.


Eligibility criteria: Inclusion Criteria:

* history of Cancer
* MFI \>40
* Karnofsky Index \>=70
* outpatient
* patient are able to give informed consent

Exclusion Criteria:

* treatment with psychostimulants in the past two weeks before screening
* active tumor disease
* depression (HADS \>10)
* cachexia (BMI \<18kg/m2)
* clinically relevant kidney disorders
* clinically relevant liver disorder
* pathological ECG-finding
* high blood pressure
* occlusive arterial disease
* angina pectoris
* cardiac arrhythmias
* CHD
* post heart-attack status
* post stroke status
* known elevated intra-ocular pressure
* known enlarged prostates
* latent and manifest hyperthyreosis
* alcohol, medication or drug dependency in the past six months or manifest drug abuse
* participation in a clinical study within the past 30 days
* participation in this study at an earlier point in time
* simultaneous participation in another clinical trial
* women of child-bearing age without adequate contraception (contraceptives, intrauterine device , no sexual intercourse)
* pregnancy (positive pregnancy test) or lactation period

Primary outcomes:
measure: General Fatigue measured by the Multidimensional Fatigue Inventory (Subscale General Fatigue)
timeFrame: 6 weeks
Secondary outcomes:
measure: Quality of Life (EORTC-QLQ C30)
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Bad Sooden-Allendorf
country: Germany
facility: Sonnenbergklinik
city: Dortmund
country: Germany
facility: Praxis Dr. Lathan
city: Hamburg
country: Germany
facility: Praxis Dr. Verpoort - Dr. Zeller
city: Köln
country: Germany
facility: Dr. J.-U. Rüffer
city: Leipzig
country: Germany
facility: Medizinische Fakultät der Universität Leipzig
city: München
country: Germany
facility: Medizinisches Versorgungszentrum - MOP
Study officials:
affiliation: Sonnenbergklinik, Hardstr. 13, D-37242 Bad Sooden-Allendorf
name: Manfred Heim, Prof.
role: PRINCIPAL_INVESTIGATOR
References: