louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06734455: Robot-Assisted Pyeloplasty in Young Children
Official title: Robot-Assisted Laparoscopic Pyeloplasty in Children Younger Than 5 Years Old
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ureterohydronephrosis
Ureter Obstruction
Child, Only
Keywords: Robot-Assisted Pyeloplasty
Child
Retrospective Study
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2024-12-16
Enrollment: 9
Sex: ALL
Minimum age (years): 0
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients younger than 5 years old, with pyeloureteric syndrome, who underwent primary robotic pyeloplasty

Brief summary: The goal of this retrospective study is to analyse the outcomes of Robot-Assisted Pyeloplasty in participants younger than 5 years old:

* indication criteria
* clinical symptoms
* operating time
* length of stay
* complications
* follow-up

Detailed description: Outcomes of Robot-Assisted Pyeloplasty in participants younger than 5 years old and comparison with the outcomes in the literature.

Eligibility criteria: Inclusion Criteria:

* Patients younger than 5 years old, who underwent primary robotic pyeloplasty, was launched between January 2014 and December 2022

Exclusion Criteria:

* Patients older than 5 years old, who underwent primary robotic pyeloplasty, was launched between January 2014 and December 2022

Primary outcomes:
measure: Presence of ureterohydronephrosis
timeFrame: Before surgery
measure: Presence of abdominal pain
timeFrame: Before surgery
measure: Presence of urinary calculi
timeFrame: Before surgery
measure: Presence of abnormal nuclear renal scans
timeFrame: Before surgery
measure: Presence of urinary tract infection
timeFrame: Before surgery
Secondary outcomes:
measure: Postoperative pain
timeFrame: After surgery and before discharge home, up to 20 days
measure: Postoperative complications
timeFrame: Through study completion, an average of 2 years
measure: Operation time
timeFrame: During surgery
measure: Hospitalization length
timeFrame: From admission to discharge home, up to 20 days
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: University Hospital, Clermont-Ferrand
state: Auvergne
Study officials:
References:
citation: Esposito C, Cerulo M, Lepore B, Coppola V, D'Auria D, Esposito G, Carulli R, Del Conte F, Escolino M. Robotic-assisted pyeloplasty in children: a systematic review of the literature. J Robot Surg. 2023 Aug;17(4):1239-1246. doi: 10.1007/s11701-023-01559-1. Epub 2023 Mar 13.
Clinical trial NCT03652155: Evaluating the Relationship Between Hard and Soft Tissue Advancement in Orthognathic Surgery
Official title: Evaluating the Relationship Between Hard and Soft Tissue Advancement in Orthognathic Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dentofacial Deformities
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
First posted: 2018-08-29
Enrollment: 45
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any patient undergoing orthognathic surgery for correction of a pre-existing dentofacial deformity.

Brief summary: This study aims to evaluate the relationship between hard and soft tissue advancement during orthognathic surgery. The use of typical pre and post operative imaging consisting of con-beam computed tomography will be used, in conjunction with a 3D camera to evaluate hard and soft tissue points before and after surgery.


Eligibility criteria: Inclusion Criteria:

* Patient's undergoing orthognathic surgery for correction of a dentofacial deformity

Exclusion Criteria:

* patients with previous orthognathic surgery patients with cranio-facial syndromes

Primary outcomes:
measure: Hard and soft tissue change
timeFrame: pre operative and post operative imaging is taken immediately before, and 24 hours post operatively, respectively.
Secondary outcomes:
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Nova Scotia Health Authority
state: Nova Scotia
Study officials:
References:
Clinical trial NCT06577155: Spinal Nalbuphine for Analgesia in Total Hip Arthroplasty
Official title: The Effect of Nalbuphine as an Adjuvant to Levobupivacaine in Subarachnoid Anesthesia in Total Hip Arthroplasty. A Double-blind, Randomized, Controlled Study.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Total Hip Arthroplasty
Analgesia
Lead sponsor: Asklepieion Voulas General Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Anastasios Mpontozis
First posted: 2024-08-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 60 patients ASA I-III, undergoing total hip arthroplasty were randomly assigned, into one of two groups, namely group E (n=30), where levobupivacaine will be administeral intrathecally ; and group N (n=30), where levobupivacaine plus nalbuphine will be administeral intrathecally. All patients will receive a standardized multimodal analgesic regimen, including a PENG block and PCA morphine. Morphine consumption during the first 24 hours postoperatively will be measured and additionally the investigators will record: Time of morphine first dose administration, NRS scores in static and dynamic conditions in 4 hours, 6 hours, 12 hours, 18 hours, 24 hours, 36 hours and 48 hours postoperatively, complications, patient satisfaction and duration of hospitalization.


Eligibility criteria: Inclusion Criteria:

* Physical status according to American Society of Anesthesiologists (ASA) I-III
* Patients scheduled for total hip arthroplasty

Exclusion Criteria:

* BMI above 40
* Serious psychiatric, mental and cognitive disorders
* Contraindication for central and/or peripheral nervous blockade
* History of allergic or other adverse reactions on the agents used in the study
* Chronic opioid

Primary outcomes:
measure: Morphine consumption
timeFrame: 24 hours
measure: NRS scores
timeFrame: 48 hours
Secondary outcomes:
measure: sensory block level
timeFrame: 1 hour
measure: motor block level
timeFrame: 1 hour
measure: sensory block onset
timeFrame: 1 hour
measure: motor block onset
timeFrame: 1 hour
measure: sensory block duration
timeFrame: 4 hours
measure: motor block duration
timeFrame: 4 hours
measure: Complications
timeFrame: 24 hours
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Asklepieion Hospital of Voula
state: Ελλάδα (+30)
Study officials:
References:
Clinical trial NCT02792855: Comparing the "snifﬁng Position" , "Simple Head Extension" and "Neutral Position"
Official title: Randomized Study Comparing the "snifﬁng Position" , "Simple Head Extension" and "Neutral Position" for Awake Orotracheal Intubation With Fiberoptic in Anticipate Difficult Airway Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Therapeutic Procedural Complication
Keywords: Snifﬁng Position
Simple Head Extension
neutral position
Lead sponsor: The First Hospital of Qinhuangdao
Sponsor class: OTHER_GOV
First posted: 2016-06-08
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: OTHER

Brief summary: The simple head extension is recommended for optimization of glottic visualization during awake orotracheal intubation whith fiberoptic bronchoscope (FOB) . However, no study to date has conﬁrmed its superiority over "snifﬁng position" . In a prospective, randomized study, the authors compared the snifﬁng position , simple head extension and "Neutral Position" in awake orotracheal Intubation.

Detailed description: The study included seventy-five patients with anticipated difficult airways. The snifﬁng position was obtained by placement of a 7-cm cushion under the head of the patient. The extension head position was obtained by by placement of a 7-cm cushion under the shoulder.

The head position was randomized as follows: neutral position group (NP group), sniffing position group (SP group) or extension position group (EP group) Randomization was performed by placing index cards with the letter NP or SP or EP into75 sealed envelopes , which were then placed in random order. At the time of a patient's enrollment, the next available envelope was placed with the patient's chart. At the time of intubation, the envelope was opened and the sequence was thus determined.

Eligibility criteria: Inclusion Criteria:

* BMI greater than 30 kg/m2
* ASA classifications of I-II, modified Mallampati classification of 3 or 4, requiring general anesthesia were included.

Exclusion Criteria:

* Exclusion criteria included age younger than 18 yr
* ASA class IV or V
* Abnormalities of the heart, brain, liver, lung, kidney and coagulation functions

Primary outcomes:
measure: Intubation Time
timeFrame: Ten minutes
Secondary outcomes:
measure: Occurrence of throat pain measured by VAS
timeFrame: one day Postoperative
Other outcomes:
Locations:
city: Qinhuangdao
country: China
facility: 中国
state: Hebei
Study officials:
affiliation: The First Hospital of Qinhuangdao
name: Ximing Qi
role: STUDY_DIRECTOR
References:
citation: Liu Z, Zhao L, Ma Z, Liu M, Qi X, Jia Q, Liang S, Yang X. Effects of head positions on awake fiberoptic bronchoscope oral intubation: a randomized controlled trial. BMC Anesthesiol. 2021 Jun 23;21(1):176. doi: 10.1186/s12871-021-01397-4.
Clinical trial NCT05303155: The Association of Gut Microbiota With COVID 19 Infection in Children
Official title: The Association of Gut Microbiota With Early Infection Stages of COVID-19 in Children
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronavirus Infections
Gut Microbiome
Childhood ALL
Lead sponsor: Hallym University Kangnam Sacred Heart Hospital
Sponsor class: OTHER
First posted: 2022-03-31
Enrollment: 40
Sex: ALL
Minimum age (years): 3
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Those who were hospitalized because of the COVID 19 were enrolled.

Brief summary: Although COVID-19 infects gastrointestinal tissues, little is known about the roles of gut commensal microbes in susceptibility to and severity of infection. The investigators will analyze the alterations in fecal microbiomes of patients with COVID-19 infection during hospitalization.


Eligibility criteria: Inclusion Criteria:

* patients infected with COVID 19

Exclusion Criteria:

* congenital heart, renal, intestinal disease
* malignancy
* immunologic disease

Primary outcomes:
measure: The analysis of fecal microbiome of patient with COVID 19
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hallym University Kangnam Sacred Heart Hospital
Study officials:
affiliation: Hallym University Kangnam Sacred Heart Hospital
name: KY YOUNG CHO, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02042755: Pilot Study With a Diffractive Trifocal IOL (POD AY 26P FineVision)
Official title: Pilot Study With a Diffractive Trifocal IOL (POD AY 26P FineVision)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bilateral Cataract
Keywords: cataract
IOL
trifocal
FineVision
Lead sponsor: Beaver-Visitec International, Inc.
Sponsor class: INDUSTRY
First posted: 2014-01-23
Enrollment: 19
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cataract patients wishing high spectacle independance after the surgery

Brief summary: The principal objective of the study is to determine the visual acuity at far, intermediate and near distances tested with optotypes at different distances from the eyes and tested with defocus addition lenses of patients implanted bilaterally with the POD 26P AY FineVision.

Secondary objective will be to test the glare and contrast sensitivity.

Detailed description: This study is a pilot study. As such it will recruit a limited number of patients : 20. Patients recruited will suffer from cataract, have no comorbidity, expressed the desire for spectacle independence and have realistic expectations.

Descriptive statistics will be used to determine the visual acuities at any distance. The occurence of glare and the determination of the contrast sensitivity will also be determined.

Eligibility criteria: Inclusion Criteria:

* - Age-related cataract
* Preoperative Corneal astigmatism \< 0.75 D
* Age 21 and older
* Visual Acuity \> 0.05
* Normal findings in the medical history and physical examination unless the investigator considers an abnormality to be clinically irrelevant.
* Patient willing multifocal implantation and with realistic expectations.

Exclusion Criteria:

* Relevant other ophthalmic diseases such as pseudoexfoliation syndrome, floppy iris syndrome, corneal pathologies, retinal pathology (diabetic maculopathy, myopic maculopathy, age related macular degeneration...)
* Previous ocular surgery or trauma.

Primary outcomes:
measure: Visual acuity
timeFrame: 3 months
Secondary outcomes:
measure: Contrast sensitivity
timeFrame: 3 months
Other outcomes:
Locations:
city: Petach Tikva
country: Israel
facility: Rabin Medical Center 49Th Jabotinsky Street
Study officials:
affiliation: Rabin Medical Center
name: Irit Bahar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01955655: Recurrent Crying Spells in Cerebral Palsy
Official title: Recurrent Crying Spells in Cerebral Palsy With Spastic Quadriparesis - A Crossover Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Recurrent Crying Spells
Keywords: Baclofen
cerebral palsy
colic
crying infant
recurrent crying spells
spasticity
therapy
Lead sponsor: Sathbhavana Brain Clinic
Sponsor class: OTHER
First posted: 2013-10-07
Enrollment: 70
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a study of recurrent crying spells in Spastic Cerebral Palsy patients and their treatment.

Detailed description: This is the first study of recurrent crying spells in Cerebral Palsy with Spastic quadriparesis depicting the diagnostic criteria and treatment.

Eligibility criteria: Inclusion Criteria:

* Recurrent Crying Spells in Cerebral Palsy with Spastic Quadriparesis.
* Age range 0-12 years.

Exclusion Criteria:

* Crying due to known causes (like hunger, sleep, food intolerance etc.),
* Crying that responded to routine management (changes in food or feeding techniques, anticolic, analgesics),
* Fever of ≥100.4ºF (38ºC),
* The infant refuses to eat or drink for more than a few hours, vomits excessively, has bloody stools, or has a change in behavior (lethargy or decreased responsiveness).
* Colic
* Worst ever crying occurring for the first time
* Respiratory, renal and hepatic diseases,
* Progressive encephalopathies,
* Received Baclofen in the previous 30 days

Primary outcomes:
measure: Change from baseline cry duration in seconds over a 10-day period while on placebo.
timeFrame: 11th to 20th day and 51st day to 60th day
Secondary outcomes:
Other outcomes:
Locations:
city: Secunderabad
country: India
facility: Sathbhavana Brain Clinic
state: Andhra Pradesh
Study officials:
affiliation: Sathbhavana Brain Clinic, Secunderabad, India
name: Nagabhushana Rao Potharaju, BScDCHMDDM
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01800955: Effectiveness of Resistive Capacitive Diathermy in Patients Affected by Knee Osteoarthritis
Official title: The Effectiveness of Resistive Capacitive Diathermy in Patients Affected by Knee Osteoarthritis: a Sham-controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Keywords: physical therapy
diathermy
knee
osteoarthritis
pain
physical function
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
First posted: 2013-02-28
Enrollment: 60
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: It is a double-blind randomized sham-controlled clinical trial to evaluate the effectiveness of resistive capacitive diathermy in subjects affected by knee osteoarthritis in comparison with a "sham" diathermy treatment. The resistive capacitive diathermy is a medical device supplying low (448 KHz) radiofrequencies with maximum output power of 200 W, used to reduce pain and inflammation and allowing healing processes. The sham diathermy treatment is administered with the device set on "on" but not active (not supplying energy). Each subject, randomly assigned to either resistive capacitive diathermy treatment (group 1) or sham-treatment (group 2) is submitted to a thirty minutes session, three times per week for a total of ten sessions. The outcome measures are the WOMAC scale (Western Ontario and McMaster Universities Arthritis Index) to assess pain and physical functioning, a visual analogic scale (VAS) for pain, the femoral quadriceps strength (MRC = Medical Research Council Scale). Outcome measures are administered at baseline (T0), at the end of the treatment protocol (T1), at 1 month (T2) and 3 months (T3) after the end of treatment.


Eligibility criteria: Inclusion Criteria:

* Patients affected by Knee osteoarthritis established by clinical examination and X-ray in postero-anterior and lateral views

Exclusion Criteria:

* Neurologic Disorders involving the lower limbs
* Systemic inflammatory disorders
* pace-maker implantation
* Severe heart disease
* Acute infections or bone tuberculosis
* Acute skin diseases
* History of surgery on the affected knee
* Cognitive or psychiatric disorders

Primary outcomes:
measure: changing of the Western Ontario and McMaster Universities Arthritis Index WOMAC)scale
timeFrame: baseline (T0), at the end of the treatment protocol (T1), at 1 month (T2) and 3 months (T3) after the end of treatment
Secondary outcomes:
measure: changing of visual analogic scale (VAS)
timeFrame: baseline (T0), at the end of the treatment protocol (T1), at 1 month (T2) and 3 months (T3) after the end of treatment
measure: MRC scale = Medical Research Council Scale
timeFrame: baseline (T0), at the end of the treatment protocol (T1), at 1 month (T2) and 3 months (T3) after the end of treatment
Other outcomes:
Locations:
city: Rome
country: Italy
facility: University Hospital "A. Gemelli", Catholic University of the Sacred Heart
Study officials:
References:
Clinical trial NCT00344955: Acute Effect of HMG-CoA Reductase Inhibition (Atorvastatin)on Renal Hemodynamics, Tubular Function and Vasoactive Hormones on Healthy Subjects
Official title: Acute Effect of HMG-CoA Reductase Inhibition (Atorvastatin)on Renal Hemodynamics, Tubular Function and Vasoactive Hormones on Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy
Keywords: HMG-COA reductase inhibition
GFR
RPF
FE
CL
Lead sponsor: Regional Hospital Holstebro
Sponsor class: OTHER
First posted: 2006-06-27
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: We wanted to test the acute effect of HMG-CoA reductase inhibition (atorvastatin) on renal hemodynamics, renal tubular function and vasoactive hormones on healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Both men and women
* Age: Between 20-50
* BMI\<30

Exclusion Criteria:

* Clinical signs or history of disease of heart, lungs, kidneys or endocrine organs.
* Abnormal lab. tests( haemoglobin, pl. sodium, pl. potassium, pl.creatinine, pl.bilirubin, pl.ALAT, pl. cholesterol, blood glucose)
* Albuminuria or glucosuria
* Cancer
* Art. hypertension
* Alcohol abuse
* Medical treatment, except oral contraceptives
* Pregnancy or breast feeding
* Blood donation less than 1 month before study

Primary outcomes:
measure: GFR
measure: RPF
measure: FEna
measure: FELi
measure: CLna
measure: CLli
Secondary outcomes:
Other outcomes:
Locations:
city: Holstebro
country: Denmark
facility: Medical Research
Study officials:
affiliation: Holstebro Sygehus
name: Erling B. Pedersen, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT01847014: Clinical Study of Macitentan in Patients With PAH to Psychometrically Validate PAH-SYMPACT Instrument
Official title: AC-055-402: An Extension of AC-055-401, a Multi-center, Open-label, Single-arm, Phase 3b Study of Macitentan in Patients With Pulmonary Arterial Hypertension to Psychometrically Validate the PAH-SYMPACT Instrument
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Pulmonary Arterial Hypertension
Keywords: Pulmonary Arterial Hypertension (PAH)
psychometric instrument
PAH-SYMPACT
Lead sponsor: Actelion
Sponsor class: INDUSTRY
First posted: 2013-05-06
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: SYMPHONY Extension is an extension of AC-055-401, a multi-center, open-label, single-arm, Phase 3b study of macitentan in patients with Pulmonary Arterial Hypertension to psychometrically validate the PAH-SYMPACT instrument. The objective is to assess the long-term safety of macitentan in subjects with PAH beyond the treatment in the AC-055-401 study.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent prior to any study-mandated procedure.
* Patients with PAH who completed study AC-055-401
* Women of childbearing potential must:
* Have a negative urine pregnancy test at Visit 1 and agree to perform monthly serum pregnancy tests.
* Agree to use two methods of contraception from Visit 1 until 1 month after study drug discontinuation.

Exclusion Criteria:

* Patients who prematurely discontinued study drug in study AC-055-401
* Females who are lactating or pregnant (positive Visit 1 pregnancy test) or plan to become pregnant during the study
* Known hypersensitivity to macitentan or its excipients or drugs of the same class

Primary outcomes:
measure: Incident Rate of Adverse Events (AEs).
timeFrame: From Visit 1 to Post-treatment safety follow-up visit (30 days after discontinuation of the study drug).
Secondary outcomes:
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Kentuckiana Pulmonary Associates
state: Kentucky
city: Cincinnati
country: United States
facility: The Carl & Edyth Lindner Center for Research & Education at The Christ Hospital
state: Ohio
Study officials:
affiliation: Actelion Pharmaceuticals US, Inc
name: Alain Romero, MD
role: STUDY_CHAIR
affiliation: Actelion Pharmaceuticals US, Inc.
name: Gary Palmer, MD, MBA
role: STUDY_CHAIR
References: