louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05401383: Implementation of Upper Gi Endoscopy Preparation: Fasting Versus Lumevis
Official title: Implementation of Upper Gi Endoscopy Preparation: RCT Fasting Versus Lumevis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: EGDS Preparation; Fasting; Lumevis
Lead sponsor: Azienda USL Modena
Sponsor class: OTHER
First posted: 2022-06-02
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: adult patients who had to perform EGDS

Brief summary: One of the major problems for the endoscopist during esophagogastroduodenoscopy (EGDS) is the presence of foam, bubbles, mucus and saliva, whether small or large, which can compromise correct endoscopic visibility. Endoscopy of the upper gastrointestinal tract, like that of the lower gastrointestinal tract, requires optimal visualization of the mucosa. It is clear that endoscopic vision is often hindered by the presence of bubbles and foam: multiple aspirations alternating with intraprocedural washes are therefore necessary, which lengthen the time necessary for the endoscopic examination. Nowadays there's no universal raccomandation about a specific preparation before EGDS.

The aim of our study is to compare fasting versus the use of simethicone premedication in combination with N-acetyl- cysteine and acetic acid (LumevisTM).

The study is observational, randomized 1:1, and double blind. Primary outcomes are: grade of mucosa visualization defined by visual analogue scale (0-10) for each analyzed segment (esophagus, stomach and duodenum).

Secondary aims: general patient satisfaction defined by visual analogue scale, eventual adverse events, duration of the exam.


Eligibility criteria: Inclusion Criteria:

* adult patients that underwent EGDS

Exclusion Criteria:

* previous upper GI surgery
* previous endoscopic bariatric procedures
* known upper GI stenosis (benign and malign)
* previous diagnosis of achalasia or motility disorders
* diabetes
* allergy to one of lumevis components
* cystinuria
* fasting not correctly respected
* pregnant or brest-feeding women
* urgent-emercengy setting
* inpatients
* patients who don't give their consent to partecipate to the trial

Primary outcomes:
measure: grade of mucosa visibility
timeFrame: 6 months
Secondary outcomes:
measure: general patient satisfaction
timeFrame: 6 months
measure: eventual adverse events
timeFrame: 6 months
measure: duration of the exam
timeFrame: 6 months
Other outcomes:
Locations:
city: Carpi
country: Italy
facility: Mauro Manno
state: MO
Study officials:
References:
Clinical trial NCT01505283: Effect of Epidural Analgesia on the Parameter ANI During Childbirth
Official title: Effect of Epidural Analgesia on the Parameter ANI During Childbirth
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Labor Pain
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2012-01-06
Enrollment: 42
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: There are many methods used for the assessment of pain in the area of anesthesia including heart rate variability which reflects the influence of the autonomic nervous system on the heart. An original index, the ANI (Analgesia Nociception Index), quantifies pain during anesthesia. Obstetric epidural analgesia is particularly suited to evaluate ANI in conscious patients with a comparison of ANI with the measurement of pain by a visual analog scale (VAS).

Evaluation of ANI is performed just before epidural catheter insertion and during the 10 first minutes after saline, sufentanil or lidocaine epidural administration.


Eligibility criteria: Inclusion Criteria:

* Over 18 years,
* ASA I or II,
* No history of cardiovascular or respiratory disease
* No cardiovascular medication
* No treatment with a tocolytic agent(salbutamol, nicardipine)
* Desiring epidural analgesia at the early phase of labor pain

Exclusion Criteria:

* Too fast labour
* A pain score at or above 70 on the pain scale
* A disturbed EKG signal or extrasystoles
* Pace-Maker
* Diabetes mellitus

Primary outcomes:
measure: Comparison of the ANI parameter with the VAS during labour
timeFrame: 2 hours
Secondary outcomes:
measure: Effects of epidural sufentanil and of epidural local anesthetic on ANI
timeFrame: 2 hours
measure: Effects of anxiety score on ANI
timeFrame: 2 hours
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Hopital Foch
state: Ile de France
Study officials:
affiliation: Hopital Foch
name: Marc Fischler, MD
role: STUDY_CHAIR
affiliation: Hopital Foch
name: Morgan Le Guen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05203783: Short-term Effects of Kinesio Taping in Patients With Mechanical Low Back Pain
Official title: Short-term Effects of Kinesio Taping in Patients With Mechanical Low Back Pain: A Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2022-01-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to estimate the effect of Kinesio tape (KT) combined with supervised exercise programs compared to exercise alone on pain, lumbar range of motion, and self-reported disability of adults with mechanical low back pain (LBP).

Methods: This was a randomized, controlled clinical trial carried out on 60 individuals with mechanical LBP. Participants were randomly assigned to the control group (n=30) that received McKenzie exercises for 7 days or experimental group (n=30) that received KT application in addition to McKenzie exercises for 7 days. Pain measured by visual analogue scale, lumbar range of motion, and the disability measured by Oswestry Disability Index (ODI) were used as outcome measures. Pre and Post measurements were taken at baseline and after 7 days.


Eligibility criteria: Inclusion Criteria:

* Individuals diagnosed with mechanical LBP by a physician

Exclusion Criteria:

* Individuals with any structural or pathological changes (spondylitis, spondylolisthesis, cauda equina syndrome, lumbar canal stenosis) in lumbar spine on X-ray or MRI
* Individuals with or without neurological signs in the lower extremity suggestive upper motor or lower motor neuron involvement,
* Individuals with a history of trauma or any surgery in the region of back,
* Individuals with recent aggravation of symptoms,
* Individuals on a waiting list for spinal surgery or had a spinal surgery in the past 6 months

Primary outcomes:
measure: Visual analogue scale (VAS)
timeFrame: The pain was measured at baseline
measure: Visual analogue scale (VAS)
timeFrame: The pain was measured at the end of intervention (7th day).
Secondary outcomes:
measure: The Oswestry Disability Index (ODI)
timeFrame: The ODI was measured at study entry 2 minutes after the pain assesment.
measure: The Oswestry Disability Index (ODI)
timeFrame: The ODI was measured at the end of intervention (7th day) 2 minutes after the pain assesment.
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Marmara University
Study officials:
References:
Clinical trial NCT00275483: Prevention of Postoperative Nausea and Vomiting (PONV) by Acupressure
Official title: Prevention of PONV by Acupressure. A Study of the Effect of a Recently Generated Danish Bracelet Vital-Band(R) Which Stimulates the Acupressure Point P6
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Nausea and Vomiting
Acupressure Point P6
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
First posted: 2006-01-12
Enrollment: 132
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether stimulation to the akupressurpoint P6 with a recently developed bracelet are effective preventing postoperative nausea and vomiting


Eligibility criteria: Inclusion Criteria:

* Female,
* Non-smoker,
* \>18 years,
* ASA 1 or 2,
* Signed patient information,
* IV-anaestesia.

Exclusion Criteria:

* Male,
* Smoker,
* ASA 3 or 4,
* Pregnancy,
* Nausea and vomiting within the last 24 h before operation,
* Diabetes,
* Carpaltunnel syndrome,
* Lymphedema of arms,
* Eczema of forearm,
* Patients who earlier has undergone removal of lymph nodes in the armpits,
* Inhalation anaestesia.

Primary outcomes:
measure: Postoperative nausea and vomiting
Secondary outcomes:
measure: 1: The use of conventionel antiemetic treatment.
measure: 2: Lenght of stay in the perioperative unit.
measure: 3: overall lenght of stay
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Herlev University Hospital, department of anaestesiology
state: Herlev
Study officials:
affiliation: Herlev Hospital
name: Birgitte Majholm, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01466283: Biomarkers in Patients With Rhabdomyosarcoma
Official title: Integrative Epigenomic Approach to Gene Discovery in Rhabdomyosarcoma (RMS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sarcoma
Keywords: childhood rhabdomyosarcoma
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2011-11-06
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cooperative Human Tissue Network (CHTN)

Brief summary: RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is studying biomarkers in patients with rhabdomyosarcoma.

Detailed description: OBJECTIVES:

* Determine genome-wide alterations in DNA methylation in ARMS and ERMS.
* Determine genome-wide DNA copy number alterations in ARMS and ERMS.
* Determine pathogenic genes and pathways by integrative genomic analysis.

OUTLINE: Genome-wide DNA-methylation analysis on ARMS, ERMS, and normal human skeletal myoblasts will be conducted using the HELP (HpaII tiny fragment Enrichment by Ligation-mediated PCR) assay. The methylation status of 1.3 million CpGs at promoters, gene bodies, and intergenic areas will be analyzed. Parallel gene expression analysis will be done and correlated with changes in methylation to uncover genes regulated by epigenetic alterations and altered by genomic losses or gains.

Genes that are altered by both genetic and epigenetic alterations in different sets of patients will be selected by the MIGHT (Multi-dimensional Integration of Genomic data from Human Tissues) algorithm to uncover new genes that are potentially involved in the pathogenesis of ARMS and ERMS. Gene ontology, pathway, and DNA motif analysis algorithms, and other computational approaches will be used to determine the biological consequences of the changes. Prioritized set of epigenetic and genetic alterations will be validated by bisulfite MassArray, FISH, and qRT-PCR in larger numbers of ARMS and ERMS samples.

Eligibility criteria: DISEASE CHARACTERISTICS:

* 10 ARMS and 10 ERMS frozen samples will be collected from the COG bank via the Cooperative Human Tissue Network (CHTN)
* Human skeletal myoblasts (ZenBio, Research Triangle Park, NC) will serve as controls

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: Genome-wide alterations in DNA methylation in ARMS and ERMS
measure: Genome-wide DNA copy number alterations in ARMS and ERMS
measure: Pathogenic genes and pathways by integrative genomic analysis
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Tomorrows Children's Institute at Hackensack University Medical Center
name: Caroline Y. Hu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03313583: French One Day Survey in 2011 - Knowing Our Population of Labile Blood Products Recipients
Official title: French Transfusion Recipients Cross Sectional Study : Get to Know the Transfusion Recipients Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blood Product Transfusion for All Conditions
Trauma
Surgical Blood Loss
Hematologic Diseases
Lead sponsor: Etablissement Français du Sang
Sponsor class: OTHER
Collaborators: name: Centre Hospitalier Universitaire de Besancon
name: Centre Hospitalier Universitaire de Nice
name: Assistance Publique Hopitaux De Marseille
name: Région Nord-Pas de Calais, France
First posted: 2017-10-18
Enrollment: 4720
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: french population of recipients

Brief summary: Describe the epidemiologic profile and clinical context of transfusion recipients in France. Describe the clinical context of transfusion.

Describe the characteristics of the transfusion prescriptions, the use of blood products and the main indications for transfusion.

Describe transfusion practice according the type of hospital stay.


Eligibility criteria: Inclusion Criteria:

• Transfusion with at least one blood product on the day of the study.

Exclusion Criteria:

* None

Primary outcomes:
measure: Number of red blood cell concentrates received
timeFrame: 1 day (cross sectional)
measure: Number of platelet concentrates recevied
timeFrame: 1 day (cross sectional)
measure: Number of plasma units received
timeFrame: 1 day (cross sectional)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Fillet AM, Desmarets M, Assari S, Quaranta JF, Francois A, Pugin A, Schuhmacher A, Lassale B, Monnet E, Cabre P, Legrand D, Binda D, Djoudi R. Blood products use in France: a nationwide cross-sectional survey. Transfusion. 2016 Dec;56(12):3033-3041. doi: 10.1111/trf.13887. Epub 2016 Nov 2.
Clinical trial NCT04768283: Cardiac Rehabilitation and Additional Physical Training in Elderly Patients After Acute Coronary Syndrome
Official title: Evaluation of Cardiac Rehabilitation Functional and Physical Capacity, Health-related Quality of Life and Associations With Frailty in Older Patients After Ischemic Heart Disease and Interventional Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Frailty Syndrome
Ischaemic Heart Disease
Keywords: Frailty
Cardiac surgery
Cardiac rehabilitation
Exercise training
Resistance training
Balance training
Lead sponsor: Lithuanian University of Health Sciences
Sponsor class: OTHER
First posted: 2021-02-24
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate functional and physical capacity, health-related quality of life and associations with frailty in older patients after ischemic heart disease and interventional treatment with an individualized physical training program in the second phase of cardiac rehabilitation.


Eligibility criteria: Inclusion Criteria:

* Patients after acute coronary syndrome and percutaneous coronary intervention or coronary bypass surgery;
* Age 65 years and older;
* 6-minute walk distance (6-MWD) ≥150 meters;
* Left ventricular ejection fraction ≥ 40%;
* Patient's agreement to participate in the study.

Exclusion Criteria:

* combined coronary artery bypass grafting and valve surgery;
* Cardiac devices;
* Diseases in the musculoskeletal system or other organs complicating physical activity and exercise training;
* Exercise-limiting comorbidities (primarily orthopedic and neurological conditions that would exclude individuals from participating in cardiac rehabilitation according to study protocol), cognitive or linguistic deficits.

Primary outcomes:
measure: Frailty level by Edmonton frail scale score
timeFrame: baseline
measure: Change from baseline functional capacity by six minutes walking test (6MWT)
timeFrame: baseline, 3 weeks
measure: Change from baseline cardiopulmonary exercise capacity by maximal load (maxWatt)
timeFrame: baseline, 3 weeks
measure: Change from baseline cardiopulmonary exercise capacity by maximal oxygen consumption (peakVO2)
timeFrame: baseline, 3 weeks
measure: Change from baseline quality of life by MacNew questionnaire
timeFrame: baseline, 3 weeks
Secondary outcomes:
measure: Change from baseline physical performance by Short Physical Performance Battery (SPPB)
timeFrame: baseline, 3 weeks
measure: Change from baseline muscular strength by one repetition maximum test (1RM)
timeFrame: baseline, 3 weeks
Other outcomes:
Locations:
city: Kulautuva
country: Lithuania
facility: LUHS hospital Kaunas Clinics Rehabilitation hospital of Kulautuva
state: Kaunas
Study officials:
References:
Clinical trial NCT04590183: The Effectiveness and Safety of FK-506 for the Treatment of Posner-Schlossman Syndrome
Official title: Peking University Third Hospital Medical Science Research Ethics Committee
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Posner Schlossman Syndrome
Keywords: Posner Schlossman Syndrome
FK-506
effectiveness
safety
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 30
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: To evaluate the effectiveness and safety of tacrolimus eye drops (FK-506) in the treatment of Posner-Schlossman Syndrome. It is expected to collect 30 patients with PSS who are in the Ophthalmology Department of Peking University Third Hospital. The included PSS patients were divided into experimental group and control group using simple randomization method. Among them, the experimental group was treated with FK-506 twice a day, and the control group was treated with prednisolone acetate ophthalmic suspension 1% 4 times a day.

For all PSS patients whose intraocular pressure is higher than 30mmHg, also add brinzolamide eye drops 3 times a day. Best corrected visual acuity, Goldmann intraocular pressure, anterior section photographs, corneal endothelial cells，corneal confocal microscope, Heidelberg retinal nerve analysis, Octopus visual field were examined on baseline and 1 week, 2 weeks, 3 weeks, 4 weeks after the treatment.


Eligibility criteria: Inclusion Criteria:

- Clinical diagnosis of PSS Must be able to communicate with doctor and understand this study

Exclusion Criteria:

- Fuchs syndrome

Primary outcomes:
measure: Silt-lamp examination of the cornea
timeFrame: 1 week after the treatment
measure: Silt-lamp examination of the cornea
timeFrame: 2 weeks after the treatment
measure: Silt-lamp examination of the cornea
timeFrame: 3 weeks after the treatment
measure: Silt-lamp examination of the cornea
timeFrame: 4 weeks after the treatment
Secondary outcomes:
measure: Goldmann ophthalmotonometer examination of intra-ocular pressure
timeFrame: 1 week after the treatment
measure: Goldmann ophthalmotonometer examination of intra-ocular pressure
timeFrame: 2 weeks after the treatment
measure: Goldmann ophthalmotonometer examination of intra-ocular pressure
timeFrame: 3 weeks after the treatment
measure: Goldmann ophthalmotonometer examination of intra-ocular pressure
timeFrame: 4 weeks after the treatment
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hosipital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Chun Zhang, PHD,MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00733083: A Comparative Study With Parenteral Oxycodone, Morphine and Dexamethasone in Postoperative Pain in Paediatric Patients
Official title: A Comparative Study With Pre-Emptive Parenteral Oxycodone, Morphine and Dexamethasone in the Treatment of Postoperative Pain in Paediatric Patients 4 to 12 Years of Age
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Post Tonsillectomy Pain
Keywords: tonsillectomy
paediatric
pain
child
opiates
pre-emptive
oxycodone
morphine
dexamethasone
Lead sponsor: University of Turku
Sponsor class: OTHER
First posted: 2008-08-12
Enrollment: 100
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this randomized, double-blind study is to compare parenteral pre-emptive oxycodone, morphine and dexamethasone with placebo in the treatment of postoperative pain in paediatric patients 4 to 12 years of age. The investigators hope to find out whether there are any differences in postoperative pain and/or adverse effects among these groups.

Detailed description: After the induction of anaesthesia and before intubation the child receives one of the research drugs in a double-blind fashion: 0.1 mg/kg of oxycodone , 0.1 mg/kg of morphine, 0.5 mg/kg dexamethasone (max 24 mg), or placebo. All the research drugs are diluted into a dose of 10 ml with NaCl 0.9%, the placebo being solely the dilute.

The patients are followed minimum 4h postoperatively: first in the recovery room, and after the patient is stable enough the study is continued in the day-patient unit. Level of pain and adverse effects are registered all on same predetermined intervals being 15 min during the first postoperative hour, followed by interval of 30 min until the discharge.

The safety measurements noted include pulse, respiratory rate, non-invasive blood pressure and peripheral oxygen saturation are recorded on the same intervals The registering of pain, adverse effects and given medication continues at home for 48 hours post operatively with a questionnaire filled by the parents.

Eligibility criteria: Inclusion Criteria:

* 4 to 12 years of age
* Scheduled to tonsillectomy
* ASA class I or II
* Written informed consent is obtained from the parents and the child (when appropriate).

Exclusion Criteria:

* Allergy to morphine, oxycodone or dexamethasone

Primary outcomes:
measure: The difference of needed rescue pain medication post operatively
timeFrame: predetermined intervals being 15 min during the first postoperative hour, followed by interval of 30 min for 4 first postop hours. At home pain and adverse effects are registered by parent at 24 hours and 48 hours.
Secondary outcomes:
measure: differences in adverse effects
timeFrame: In hospital 4 hours with first hour in 15 min intervals, then 30 min. At home 24+48h
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Turku University hospital
Study officials:
affiliation: Turku University Hospital
name: Tuula Manner, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: