louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02782286: Morphine Versus Ketorolac in Low Back Pain
Official title: The Analgesic Effects of Morphine Versus Ketorolac in Low Back Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Low Back Pain
Keywords: ketorolac
pain relieve
morphine
Lead sponsor: Bucharest Emergency Hospital
Sponsor class: OTHER
First posted: 2016-05-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The study is prospective, double blinded, randomised controlled and has the purpose to compare the analgesic effects of ketorolac or morphine intravenous in low back pain.

Detailed description: The study will take place in the Emergency Department of the Clinical Emergency Hospital Bucharest and will compare the analgesic effects of ketorolac tromethamine against morphine in low back pain.

The patients will be randomised to receive either ketorolac 30 mg intravenous (diluted in 20 ml of 0,9% saline) or morphine 0,1 mg/kg weight intravenous. A scale of 1-10 will be used for measuring the pain, and the effects of the treatment will be evaluated at 15 minutes and 30 minutes from the administration of the drugs. After 30 minutes if there is no significant reduction of the pain a rescue therapy will be used : acetaminophen 1 g, sodic metamizole 1g both diluted in 500 ml saline and the other medication not used from the study (morphine or ketorolac tromethamine).

Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of musculoskeletal low back pain
* grade 5 pain on a 1-10 visual pain scale

Exclusion Criteria:

* contraindications of ketorolac or opioids
* pregnancy
* known allergies to ketorolac or opioids
* post-traumatic low back pain
* refusal of participation

Primary outcomes:
measure: Reducing the grade of pain
timeFrame: 15 minutes, 30 minutes
Secondary outcomes:
measure: Time of staying in emergency department
timeFrame: 30 minutes, 1 hour, 2 hours, 3 hours
measure: The necessity neurosurgery consult - questionnaire
timeFrame: 1 month
measure: The cost of each treatment
timeFrame: 1 hour
measure: The necessity to use rescue therapy
timeFrame: 30 minutes
measure: Side effects of each treatment
timeFrame: 30 minutes
Other outcomes:
Locations:
Study officials:
affiliation: Clinical Emergency Hospital Bucharest
name: Dan Marinescu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01218386: Pretreatment With Estradiol Valerate
Official title: Programmation of GnRH Antagonist Cycles With Estradiol Valerate: Impact on the Stimulation in IVF/ICSI.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Infertility
Keywords: ICSI
GnRH antagonists
planning
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2010-10-11
Enrollment: 80
Sex: FEMALE
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 present study is set up to evaluate the efficacy of a programmation by administration of estrogen valerate during 6 or more consecutive days. In this prospective randomised trial, we study the impact of administration of Progynova® during 6, 7,8 9 or 10 consecutive days during the luteo-follicular transition period of the menstrual cycle.

Detailed description: See Section Interventions

Eligibility criteria: Inclusion Criteria:

\< 36 years old on day of randomisation FSH \< 12 (in the early follicular phase) Normal ultrasound scan, i.e. presence of both ovaries, without evidence of abnormality within 6 months prior to randomisation.

Regular menstrual cycles of 21-35 days, presumed to be ovulatory. BMI between 18 and 29 (both inclusive) 1st or 2nd trial IVF or ICSI

Exclusion Criteria:

≥ 36 years old on day of randomisation Endometriosis ≥ grade 3 PCOS Poor responders (development of \< 4 follicles in a previous IVF/ICSI cycle) Endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver or kidney)

Primary outcomes:
measure: number of egg retrievals on weekend days
timeFrame: up to 9 months
Secondary outcomes:
measure: The mean number of coc in each treatment group
timeFrame: up to 9 months
Other outcomes:
Locations:
city: Brussel
country: Belgium
facility: UZ Brussel, Centre for Reproductive Medicine
Study officials:
affiliation: Universitair Ziekenhuis Brussel
name: Paul Devroey, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05052086: Magnetomotoric Ultrasound (MMUS) in Rectal Cancer
Official title: Magnetomotoric Ultrasound (MMUS) in the Staging of Rectal Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Rectal Cancer
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2021-09-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Included patients will undergo magnetomotoric ultrasound in addition to conventional MRI. The results of MRI examination and magnetomotoric ultrasound will be compared with final histopathology.
Primary purpose: DIAGNOSTIC

Brief summary: Magnetomotoric ultrasound, combines conventional ultrasound with a time-varying magnetic field. The aim is to improve diagnosis of mesolectal lymph nodes.

Detailed description: Magnetomotoric ultrasound, combines conventional ultrasound with a time-varying magnetic field. Nanoparticles are injected close to the rectal cancer and migrate to adjacent lymph nodes.The time-varying magnetic field will influence the nano particles in the lymph node enhancing diagnosis of affected lymph nodes. The aim is to improve diagnosis of mesolectal lymph nodes and compare the results of magnetomotoric ultrasound with MRI and final histopathology.

Eligibility criteria: Inclusion Criteria:

* Rectal cancer
* Scheduled for total mesorectal surgery
* Informed consent

Exclusion Criteria:

* Not able to give informed consent
* Synchronus colorectal cancer

Primary outcomes:
measure: Accuracy of mesorectal lymph node diagnosis with MMUS, compared with final histopathology
timeFrame: Approximately 1 hour after MMUS
measure: Accuracy of mesorectal lymph node diagnosis with MMUS, compared with preoperative MRI
timeFrame: Approximately 1 hour after MMUS
Secondary outcomes:
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: Skane University Hospital, Malmö, section of Surgery
state: Skåne
Study officials:
References:
Clinical trial NCT03714386: Study to Explore Morbimortality in Patients Dialyzed With the Theranova HDx in Comparison to On-Line-Hemodiafiltration
Official title: A Multicentre, Open-label, Prospective, Randomized Study to Explore the Morbimortality in Patients Dialyzed With the Theranova HDx in Comparison to On-Line - Hemodiafiltration (Study MoTHER HDx)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Kidney Disease Requiring Chronic Dialysis
Lead sponsor: Fundación Senefro
Sponsor class: OTHER
First posted: 2018-10-22
Enrollment: 700
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: study to evaluate the safety and efficacy of Expanded Hemodialysis (HDx) compared to hemodiafiltration (HDF) in patients with chronic kidney disease in Spain for up to 36 months.

Approximately 700 patients will be included.

Detailed description: This is an open-label, prospective, 1:1 randomized, parallel-group, study to evaluate the safety and efficacy of Expanded Hemodialysis (HDx) compared to hemodiafiltration (HDF) in patients with chronic kidney disease in Spain for up to 36 months.

Stable incident hemodialysis patients from hemodialysis in-hospital units and related satellite centers in Spain.

Eligibility criteria: Inclusion Criteria:

* End stage Renal Disease (ESRD) patients
* Age\> 18 years old
* HD therapy three times per week for 3 months at least and a maximum of 24 months.

Exclusion Criteria:

* No informed consent provided
* Synthetic membrane allergy
* Pregnant, breastfeeding, or planning to become pregnant
* Active systemic diseases: liver cirrhosis, malignancy prior to enrollment (except basal cell skin or similar) and / or immunosuppressive treatment in the 3 months before the recruitment.
* Scheduled for living-donor transplantation within the study period
* Patients with a significant residual renal function (defined as Urea clearance \>2,5 ml/min.
* Currently participating in another interventional clinical study or has participated in another interventional clinical study in the last 3 months that may interfere with this study.

Primary outcomes:
measure: Cardiovascular morbility
timeFrame: every 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario Infanta Leonor
Study officials:
affiliation: Hospital Universitario Infanta Leonor
name: Rafael Perez Garcia, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00921986: Biospecimen Repository for Cardiac Arrhythmias at the Cleveland Clinic
Official title: Cleveland Clinic Arrhythmia Biospecimen Repository (Cleveland Clinic Arrhythmia BioBank)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Arrhythmias, Cardiac
Keywords: genetics
biorepository
cardiac death
atrial fibrillation
ventricular fibrillation
ventricular tachycardia
supraventricular tachycardias
premature ventricular complexes
premature atrial complexes
atrioventricular and intraventricular blocks
sinus node dysfunction
syncope
vasovagal reactivity
postural orthostatic tachycardia syndrome
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2009-06-17
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing arrhythmia procedures, cardiac surgery or inpatient or outpatient evaluations for arrhythmias at the Cleveland Clinic or from outside collaborative institutions or from other clinical trials.

Brief summary: Biorepository of blood and or tissue samples from patients presenting with cardiac arrhythmia syndromes.

Detailed description: The long-term objective of this research is to find genes and biologic pathways causing arrhythmia syndromes and other diseases or conditions. In order to achieve this objective the investigators will collect comprehensive phenotypic data and corresponding blood and/or tissue samples into a biorepository registry of patients, presenting for cardiac arrhythmia evaluation and/or treatment, and control subjects without arrhythmias. This biorepository will be composed of two parts: 1) An Arrhythmia Biorepository of blood and tissue from patients undergoing arrhythmia procedures, cardiac surgery, or inpatient or outpatient evaluations for arrhythmias, and 2) A Collaborative Sample Biorepository for de-identified samples and data from outside institutions and clinical trials.

Eligibility criteria: Inclusion Criteria:

* Male or female at least 18 years old
* Subjects with a history of or current cardiac arrhythmia, family members of subjects with cardiac arrhythmias, or no cardiac arrhythmia if a Control Subject.

Exclusion Criteria:

* Subjects previously enrolled in the Arrhythmia BioBank

Primary outcomes:
measure: Genetic variants associated with arrhythmias
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Mina K. Chung, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06727786: Serious Game to Teach Opioid Overdose Response
Official title: Using a Serious Game to Teach People How to Recognize and Respond to Opioid Overdose
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Opioid Overdose
Lead sponsor: University of Nevada, Reno
Sponsor class: OTHER
First posted: 2024-12-11
Enrollment: 850
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study evaluates the efficacy of a serious game to teach students how to recognize and respond to opioid overdose

Detailed description: This study uses an interactive realistic film depicting an opioid overdose to teach high school/middle school students how to recognize and respond to opioid overdose. The film features a person who finds their friend unresponsive, with evidence of opioid use. The unresponsive friend demonstrates signs of opioid overdose. The hero must recognize opioid overdose, administer naloxone (opioid antedote) and perform CPR. The film is made interactive by the narrator pausing the action of the film, and asking learners to answer questions/make choices.

Efficacy is tested on the day of training, and 2-4 months later. Efficacy is measured by student ability to correctly administer naloxone to a manikin, perform CPR, and answer knowledge questions about opioid overdose. Other studied metrics include student engagement/enjoyment, attitudes/biases, and emotions created by the training. These will be tested through validated questionnaires.

Eligibility criteria: Inclusion Criteria:

* Student at participating school, enrolled in Health or Science Class

Exclusion Criteria:

* None

Primary outcomes:
measure: Naloxone administration Skill
timeFrame: Day of training, and 2-3 months
Secondary outcomes:
measure: CPR Skill
timeFrame: Day of training, and 2-3 months
measure: Attitudes towards opioid overdose
timeFrame: Day of training, and 2-3 months
measure: Knowledge of opioid overdose response
timeFrame: Day of training, and 2-3 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01876186: Comparisons of 3-month Versus 6-month Solifenacin Treatment for Female OAB Patients
Official title: Comparisons of Urodynamic Effects, Urinary Nerve Growth Factor Levels and Outcomes in Female Overactive Bladder Patients After 3-month Versus 6-month Solifenacin Treatment: a Randomized Prospective Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Overactive Bladder Syndrome
Keywords: antimuscarinic treatment
urodynamic studies
nerve growth factor
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2013-06-12
Enrollment: 200
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate whether prolonged period of treatment (6 months) can have a better therapeutic outcome than conventional period (3 months) of antimuscarinics.

Detailed description: Overactive bladder syndrome (OAB), with or without urge incontinence, is characterized by urinary urgency, frequency and nocturia. Thus, patients with OAB could be considered to have a reduced quality of life. Patients with overactive bladder syndrome have a higher risk of falling and fracture due to nocturia. OAB affects around 17 % of female population. At present, muscarinic receptor antagonists are the ﬁrst-line pharmacotherapeutic agents for OAB. However, discontinuation of the treatment often results in symptom relapse. Until now, optimal duration of the treatment and durability of the efﬁcacy have not been determined. We plan to use urodynamic studies outcome to evaluate therapeutic effect, with the change of urinary nerve growth factor level. This study is a randomized prospective study, comparing female OAB patient after 3 months and 6 months of antimuscarinic treatment.

The purpose of this study is to investigate the difference of urodynamic effects, therapeutic effect and urinary urinary nerve growth factor level between OAB females after 3 months and 6 months antimuscarinic treatment.

Eligibility criteria: Inclusion Criteria:

* Women who have overactive bladder syndrome

Exclusion Criteria:

* Women who are less than 20 year-old

Primary outcomes:
measure: The rate of normalized urodynamic findings
timeFrame: 6 months
Secondary outcomes:
measure: The cure rate of overactive bladder
timeFrame: 24 weeks
measure: The recurrence rate of overactive bladder
timeFrame: 2.5 years
measure: The difference of urine nerve growth factor level
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Obstetrics & Gynecology, National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Ho-Hsiung Lin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02156986: Chewing Capability Study for Infants and Toddlers
Official title: Effect of Food Structural Properties on Infants and Toddlers Mastication Abilities
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2014-06-05
Enrollment: 68
Sex: ALL
Minimum age (years): 9
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The subjects investigated will be healthy infants and toddlers ranging from 9 to 36 months in 5 groups:

* 9 months (±2 weeks),
* 12 months (±1 month),
* 18 months (±2 months),
* 24 months (±2 months),
* 36 months (±3 months).

Brief summary: The main objective of the study is to conduct a pilot study on the characterization of the mastication abilities of infants and toddlers using different commercial cereal based products in order to gain knowledge and be able to plan future studies.


Eligibility criteria: Inclusion Criteria:

* Born at term (37+ weeks)
* Familiar with solid foods
* No known history of food allergies
* Child must be within 2 weeks of the targeted age group for 9 months, within 1 month for 12 months, within 2 months for 18 and 24 months, and within 3 months for 36 months for this study.
* English must be the primary language of the participant and family.
* Having obtained his/her caregiver's or legal representative's informed consent.

Exclusion Criteria:

* History of speech/language, cognitive, or physical impairments as indicated on the self-reported medical history questionnaire completed by caregiver or legal guardian
* Any previously undiagnosed speech/language or cognitive impairment detected by the Investigator. In the case a subject is identified as being at risk for a communication or feeding impairment, the caregiver will be notified and provided with a list of local speech-language pathology providers who could perform a formal assessment
* History of poor weight gain/ weight loss, food allergies, difficulties with sucking, difficulties with chewing and/ or swallowing, frequent drooling (for age groups 18, 24, and 36 months), frequent choking, gastro-esophageal reflux, frequent spitting up/ vomiting (for age groups 18, 24, and 36 months) or irritability after feedings/ eating
* Latex allergies
* Currently participating in or having participated in a similar clinical trial related to food/diet within the last 9 months
* Caregiver must not be under the age of 18 years old.

Primary outcomes:
measure: Muscle activities involved in the mastication using Electromyography (EMG)
timeFrame: One day during the study visit 2
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: MGH Institute of Health Professions
state: Massachusetts
Study officials:
References:
Clinical trial NCT04199286: Bilateral and Unilateral Horizontal Strabismus Surgery
Official title: Assessment of Symmetrical and Asymmetrical Horizontal Strabismus Surgery: Efficacy and Lateral Incomitance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Strabismus
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2019-12-13
Enrollment: 40
Sex: ALL
Minimum age (years): 4
Maximum age (years): 28
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was done in alternating strabismus patients to compare symmetrical muscle surgery and asymmetrical one as regard efficacy and lateral incomitance after surgery


Eligibility criteria: Inclusion Criteria:

* more than 3 years old.
* alternating esotropia or exotropia

Exclusion Criteria:

* unilateral strabismus
* paralytic or restrictive strabismus

Primary outcomes:
measure: There was 95% success rate in asymmetrical group compared with 90% in symmetrical one
timeFrame: one and half year
Secondary outcomes:
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Faculty of Medicine
state: Minia
city: Minya
country: Egypt
facility: Mohamed F K Ibrahiem
Study officials:
affiliation: Assistant professor
name: Sahar TA Abdelaziz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ismail AA, Abdelkader MF, Mohamed AA, Abdelaziz ST. Evaluation of Efficacy and Lateral Gaze Incomitance in Symmetrical and Asymmetrical Surgery for Concomitant Esotropia and Exotropia. Clin Ophthalmol. 2021 Aug 26;15:3613-3621. doi: 10.2147/OPTH.S326659. eCollection 2021.
Clinical trial NCT05408286: Post Covid-19 Quality of Life After Hospital Discharge in Patients Treated With NIV/C-PAP
Official title: Impact of COVID-19 on Quality of Life After Hospital Discharge in Patients Treated With NIV/C-PAP: an Observational, Prospective Multicenter Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Quality of Life
Lead sponsor: Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
Sponsor class: OTHER
First posted: 2022-06-07
Enrollment: 145
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consisted of patients treated with NIV/CPAP, admitted to the COVID-19 wards of the AO SS Antonio e Biagio and Cesare Arrigo in Alessandria (the promoting center), the Azienda Sanitaria Locale Bt (Barletta, Andria, Trani) and the Azienda Socio Sanitaria Territoriale in Lecco, from November 2020 to June 2021

Brief summary: A multicenter longitudinal study with data collection at 4 and 8 months after hospital discharge.

Detailed description: The study population consisted of patients treated with NIV/CPAP, admitted to the COVID-19 wards of the AO SS Antonio e Biagio and Cesare Arrigo in Alessandria (the promoting center), the Azienda Sanitaria Locale Bt (Barletta, Andria, Trani) and the Azienda Socio Sanitaria Territoriale in Lecco, from November 2020 to June 2021. The study assessed at 4 and 8 months after hospital discharge in the patient's home environment, quality of life, residual disability, anxiety and insomnia.

Enrollment took place only after the approval of the Ethics Committee of each participating center.

Eligibility criteria: Inclusion Criteria:

All patients aged ≥18 years admitted for COVID-19 pneumonia treated with NIV/CPAP, discharged to their home with a negative molecular swab and signed informed consent were included in the study

Exclusion Criteria:

Exclusion criteria were set in; patients admitted for COVID-19 pneumonia treated with NIV/CPAP and invasive ventilation and patients with pre-existing cognitive disorders at the hospital admission date.

Primary outcomes:
measure: COVID-19 qualità di vita
timeFrame: 8 mesi
Secondary outcomes:
Other outcomes:
Locations:
city: Alessandria
country: Italy
facility: Azienda ospedaliera nazionale SS Antonio e Biagio e Cesare Arrigo
Study officials:
affiliation: Azienda Ospedaliera nazionale SS Antonio e Biagio e Cesare Arrigo, Alessandria, Italy, EU
name: Tatiana Bolgeo, PhD
role: PRINCIPAL_INVESTIGATOR
References: