louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03075293: Pain Management of Children With Appendicitis in the Emergency Department (ER)
Official title: Pain Management of Children With Appendicitis in the Emergency Department (ER)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pain
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2017-03-09
Enrollment: 500
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All children with appendicitis admitted to the ER

Brief summary: The aim of this retrospective study is to determine the percentage of children with appendicitis who were given analgesics or opioids in the ER, to reduce their pain.


Eligibility criteria: Inclusion Criteria:

* Children with appendicitis

Exclusion Criteria:

-

Primary outcomes:
measure: Percentage of children given pain medication
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
affiliation: Hillel Yaffe Medical Center
name: Muna Kanaani, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03661593: Aniseikonia in Epiretinal Membrane Patients
Official title: Aniseikonia in Epiretinal Membranes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Epiretinal Membrane
Lead sponsor: Glostrup University Hospital, Copenhagen
Sponsor class: OTHER
First posted: 2018-09-07
Enrollment: 25
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Examination of aniseikonia in epiretinal membranes patients before and after surgery

Detailed description: Phakic patients woth epiretinal membranes are examined for aniseikonia and refractive status before and after surgery. Follow up is one year.

Eligibility criteria: Inclusion Criteria:

* Epiretinal membrane Phakic on both eyes

Exclusion Criteria:

* no previous eye surgeries
* refractive status +/- 2 seq

Primary outcomes:
measure: Aniseikonia
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Eye department, Nordre ringvej 56
state: Glostrup
Study officials:
References:
Clinical trial NCT05814393: To Evaluate the Efficacy and Safety of JW0201 Added on in Patients with Type 2 Diabetes Mellitus
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel, Phase Ⅲ Study to Evaluate the Efficacy and Safety of JW0201 Added on in Patients with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control with C2202 and C2203
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: JW Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2023-04-14
Enrollment: 200
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A multicenter, randomized, double-blind, placebo-controlled, parallel, phase Ⅲ study to evaluate the efficacy and safety of JW0201 added on in patients with type 2 diabetes mellitus who have inadequate glycemic control with C2202 and C2203

Detailed description: A multicenter, randomized, double-blind, placebo-controlled, parallel, phase Ⅲ study

Eligibility criteria: Inclusion Criteria:

* Type 2 Diabetes Mellitus

Exclusion Criteria:

* Type 1 Diabetes Mellitus
* The subject not meet the specified HbA1c and FPG

Primary outcomes:
measure: HbA1c (24 Weeks) lowering effect
timeFrame: 24 Weeks
Secondary outcomes:
measure: HbA1c lowering effect
timeFrame: 6, 12, 18, 32, 40, 52 Weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
Study officials:
affiliation: Kangbuk Samsung Hospital
name: Cheol-Young Park
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01478893: Safety and Pharmacodynamics of SEL-068 Vaccine in Smokers and Non-Smokers
Official title: A Phase 1 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Pharmacodynamics of Increasing Subcutaneous Doses of SEL-068 in Healthy Non-Smoker and Smoker Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Smoking Cessation
Keywords: nicotine vaccine
smoking vaccine
smoking cessation
SEL-068
Lead sponsor: Selecta Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2011-11-23
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and pharmacodynamics of SEL-068. Increasing subcutaneous doses of SEL-068 will be administered to healthy non-smoker and smoker volunteers. The resulting safety profile and anti-nicotine antibody levels will be evaluated.


Eligibility criteria: Primary Inclusion Criteria:

* Healthy Smokers
* Healthy non-smokers
* Written informed consent

Primary Exclusion Criteria:

* Prior exposure to nicotine vaccines
* Female subjects of childbearing potential
* Current use of immunosuppressive agents
* History of or current autoimmune disorder of immunosuppressive condition (e.g. HIV infection)
* Concurrent participation or participation within 8 weeks prior to the initial study drug administration in a drug/device or biologic investigational research study.

Primary outcomes:
measure: To assess the safety and tolerability of multiple subcutaneous injections of SEL-068 as assessed by frequency of vaccine related adverse events, graded by severity
timeFrame: 36 weeks
Secondary outcomes:
measure: Immunogenicity of SEL-068 by measuring anti-nicotine antibody titers by Enzyme-Linked Immunosorbent Assay (ELISA).
timeFrame: 36 weeks
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: SGS LSS Clinical Pharmacology Unit
Study officials:
affiliation: SGS LSS Clinical Pharmacology Unit - Antwerpen
name: Eva Vets, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04904393: Subanalysis in Patients With CARDIoLAMinopathy Enrolled to REPORT-CCM Registry
Official title: Subanalysis in Patients With CARDIoLAMinopathy Enrolled to Retrospective and Observational Registy on Cardiac Contractility Modulation Therapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Laminopathy
Lamin A/C Gene Mutation
Heart Failure
Keywords: Heart Failure
Cardiac Contyractility Modulation
Quality of Life
Lead sponsor: Monaldi Hospital
Sponsor class: OTHER
First posted: 2021-05-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with standard indication to CCM therapy device implantation with Cardiolaminopahy aetiology and in HF status.

Brief summary: Observational, retrospective registry with acute and chronic endpoints

Detailed description: This registry includes patients who have undergone CCM device implant and due to the presence of heart failure with reduced left ventricular systolic function and symptomatic despite optimal therapy, with LMNA-DCM etiology for to assess the impact on CCM therapy in term of improvemente of QoL and reduction HF hospitalizations

Eligibility criteria: Inclusion Criteria:

* Male or non-pregnant female, aged 18 or older;
* chronic heart failure with symptomatic left ventricular systolic function (NYHA class II-IVa) with or without device already implanted (for example AICD, pace-maker);
* Appropriate and optimized medical therapy;
* Patient signed and dated informed consent form at enrollment;
* life expectancy\> 1 year due to the absence of comorbidities that reduce the prognosis

Exclusion Criteria:

* absence of venous access available for implant;
* contraindication to the interventional procedure of CCM device implant (for example presence of Mechanical tricuspid vale);
* pregnant patients

Primary outcomes:
measure: Improvement of QoL
timeFrame: 12 months
measure: Reduction of HF Hospitalizations and Emergency Ward accesses
timeFrame: 12 months
measure: Improvement of Fuctional Capacity
timeFrame: 12 months
Secondary outcomes:
measure: Assess of HF biomarkers trends
timeFrame: 12 months
Other outcomes:
Locations:
city: Naples
country: Italy
facility: AO dei Colli - Monaldi Hospital
Study officials:
affiliation: Ao dei Colli - Monaldi Hospital
name: Antonio D'Onofrio, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03487393: VitalFlow Healthy Volunteer Study
Official title: Determination of Threshold of Stimulation, Tolerability and Safety of Magnetic Nerve Stimulation In Healthy Subjects: an Exploratory Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Normal Subject / Healthy Volunteers
Keywords: facial nerve
magnetic stimulation
cerebral blood flow
Lead sponsor: Nervive, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Centro Nacional de Investigacion en Imagenologia e Instrumentacion Medica (CI3M)
First posted: 2018-04-04
Enrollment: 37
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective
Primary purpose: TREATMENT

Brief summary: Find the stimulation threshold of the facial nerve (ganglion Geniculate) associated with tolerability and safety in subjects Healthy humans.

Detailed description: Magnetic stimulation of the facial nerve (geniculate ganglion) in humans can induce changes in cerebral blood flow safely, without generating adverse effects unknown to the technique.

Our specific objectives:

1. Perform tolerability and safety tests of magnetic stimulation on the facial nerve.
2. Establish the optimal stimulation threshold associated with tolerability in order to apply it to the final design of the Magnetic Stimulation (MS) system.
3. Measure whether the threshold found shows any increase in cerebral perfusion in the subject with respect to their baseline.

Eligibility criteria: Inclusion Criteria:

* Healthy subjects
* Normal audiometry chart (Evaluated at the time of your inclusion).
* Normal neurological examination at time of inclusion.

Exclusion Criteria:

* Subjects with a diagnosis of epilepsy, seizures, facial nerve palsy, migraine or recurrent headaches, glaucoma or neuropathies.
* Subjects in breastfeeding or in pregnancy. (To be confirmed with test strip).
* Subjects with acute or acute chronic medical conditions.
* Age less than 20 years or greater than 40 years.
* Carotid surgery.
* Episodes of syncope.
* Known arteriosclerosis anywhere on the body
* Metal implants (cochlear implants, pacemakers, metal prostheses).
* Intracranial abnormalities observed by MRI or MRA (Evaluated at time of inclusion of the subject).
* Intraocular pressure\> 22mmHg (Evaluated at time of inclusion of the subject)

Primary outcomes:
measure: Change in perfusion index of cerebral blood flow
timeFrame: 10 minutes post-stimulation
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Centro Nacional de Investigación en Imagenología e Instrumentación Medica
state: Cdmx
Study officials:
References:
Clinical trial NCT02105493: Nitroglycerin Prevents Radial Artery Occlusion
Official title: A Novel Approach to Reduce Radial Artery Occlusion After Trans-Radial Catheterization: Post-Procedural/Pre-Hemostasis Intra-Arterial Nitroglycerin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Injury of Radial Artery
Keywords: Nitroglycerin
Radial Artery Occlusion
Transradial Catheterization
Lead sponsor: National Cardiovascular Center Harapan Kita Hospital Indonesia
Sponsor class: OTHER
First posted: 2014-04-07
Enrollment: 1706
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: PREVENTION

Brief summary: Trans-radial approach (TRA) has becoming popular and widely adopted over the last decade. However, radial artery occlusion (RAO) continues to be one of the limitation of trans-radial access and potentially limits the radial artery as an access site in the future. Several strategies have been used to decrease the incidence of RAO including the use of anticoagulation, maintenance of patency during hemostasis, or shortening the duration of compression. Currently, there is no data whether vasoactive pharmacological therapy such as nitroglycerin administered intra-arterially at the end of the procedure may reduce the incidence of RAO. It is hypothesized that the addition of nitroglycerin (nitric oxide donor) at the end of a TRA procedure may reduce the incidence of RAO.


Eligibility criteria: Inclusion Criteria:

* Sequential patients undergoing trans-radial catheterization in the institution will be consented to be randomized to receive either 500 microgram nitroglycerin (Group A) or a placebo (Group B) administered intra-arterially through the sheath at the end of the procedure.

Exclusion Criteria:

* Patients with cardiogenic shock or hemodynamically unstable
* Unable to tolerate nitrates

Primary outcomes:
measure: Incidence of radial artery occlusion as confirmed by absence of antegrade flow in vascular high resolution ultrasound
timeFrame: One Day After the Index Procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: National Cardiovascular Center Harapan Kita
Study officials:
affiliation: National Cardiovascular Center Harapan Kita
name: Surya Dharma, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dharma S, Kedev S, Patel T, Sukmawan R, Gilchrist IC, Rao SV. Post-procedural/pre-hemostasis intra-arterial nitroglycerin after transradial catheterization: A gender based analysis. Cardiovasc Revasc Med. 2016 Jan-Feb;17(1):10-4. doi: 10.1016/j.carrev.2015.12.002. Epub 2015 Dec 22.
Clinical trial NCT00037193: Acute Regulation of Parathyroid Hormone by Dietary Phosphate
Official title: Acute Regulation of Parathyroid Hormone by Dietary Phosphate
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Secondary Hyperparathyroidism
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
First posted: 2002-05-17
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: Patients with end stage renal disease often have secondary hyperparathyroidism due to high phosphorus and low calcium levels in the blood. Preliminary animal studies and our initial human study indicate that the parathyroid hormone levels may change quickly based on the ingestion of phosphorus, prior to any change in the blood levels of calcium or phosphorus. This follow-up study will attempt to determine if the effect is independent of an increase in the blood glucose level. If so, this would suggest an as yet unidentified gastrointestinal receptor that mediates parathyroid hormone levels. This may affect the timing of administration and the type of phosphate binder used in treating patients with secondary hyperparathyroidism. The knowledge that parathyroid hormone levels can change acutely may also affect the recommended timing of blood samples

Detailed description: This study is observational and no drugs or other interventions will be used. The population targeted in this study will be adult patients already on chronic hemodialysis with a diagnosis of secondary hyperparathyroidism. Experimental design will involve the use of a glucose clamp to maintain a constant, mild increase in blood glucose levels. Frequent, scheduled lab tests will be obtained during the period of hyperglycemia to evaluate phosphorous, calcium, and glucose levels and the relationship of any change in their values to changes in the parathyroid hormone level. The primary outcome will be to evaluate for any change in the parathyroid hormone level in the presence of hyperglycemia and to compare these results to that of our initial study

Eligibility criteria: 1. Patients 21 years of age or older
2. Receiving treatment with hemodialysis for at least 90 days.
3. Serum parathyroid hormone level greater than 200 pg/ml
4. Serum phosphorus level greater than 4 mg/dl

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: St. Louis
country: United States
facility: Washington University Medical School
state: Missouri
Study officials:
References:
Clinical trial NCT05924893: The Use of Naltrexone Hydrochloride to Promote Healing in Patients With Resistant Non-infectious Corneal Ulcer
Official title: The Use of Naltrexone Hydrochloride to Promote Healing in Patients With Resistant Non-infectious Corneal Ulcer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cornea Ulcer
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2023-06-29
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The opioid growth factor-receptor antagonist-naltrexone hydrochloride (NTX)- has gained much reach interest for applications in ophthalmology, because of its novel mechanism of action for speeding up corneal wound healing in both diabetics and non-diabetics, effective both locally and systemically and its availability as a low molecular weight synthetic drug.

Detailed description: Corneal epithelial defects generally heal within 2 days without complications, in some patients with decreased corneal sensitivity, such as patients with severe dry eye, corneal neuropathy, or autoimmune diseases, the corneal epithelium shows a reduced tendency for spontaneous healing Resistant corneal ulcers may appear as epithelial defects associated to Bowman's layer disruption with associated damage and partial variable loss of superficial corneal stroma larger than 2 mm in diameter that persist more than 2 weeks even treated with conventional treatment . Noninfectious corneal ulcers have a similar clinical presentation like that of infectious ulcers but with no known infectious cause . Resistant corneal ulcer can lead to serious complications such as infection, inflammation, corneal scarring, opacification, corneal thinning, and perforation . In our study NTX accelerated healing of resistant corneal ulcers that was refractory to conventional treatment with lubricant eye drops and was safe with no complications reported in all treated eyes.

Eligibility criteria: Inclusion Criteria:

* refractory non infective corneal ulcer

Exclusion Criteria:

* infection

Primary outcomes:
measure: healing of ulcer
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Faculty of Medicine
Study officials:
affiliation: Minia University
name: Hossam Moharram, professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Alio JL, Abad M, Artola A, Rodriguez-Prats JL, Pastor S, Ruiz-Colecha J. Use of autologous platelet-rich plasma in the treatment of dormant corneal ulcers. Ophthalmology. 2007 Jul;114(7):1286-1293.e1. doi: 10.1016/j.ophtha.2006.10.044. Epub 2007 Feb 26.
Clinical trial NCT00888693: A Multiple Dose Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ABT-288 in Stable Subjects With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Schizophrenia
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2009-04-28
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Evaluate the safety, tolerability and pharmacokinetics of ABT-288 in order to determine the maximum tolerated dose of ABT-288 in stable schizophrenic volunteers receiving treatment with an atypical antipsychotic.


Eligibility criteria: Inclusion Criteria:

* Subject has signed informed consent;
* Current DSM-IV-TR diagnosis of schizophrenia;
* Clinically stable on the same single second-generation antipsychotic for the past 8 weeks;
* Meets study-specific PANSS criteria;
* Willing and able to cooperate with cognitive testing
* Females are not pregnant, not breast-feeding;
* Females are post-menopausal or surgically sterile or practicing birth control;
* Males are surgically sterile or agree to be sexually inactive or use barrier method of birth control

Exclusion Criteria:

* Subject has a substance dependence disorder that has not been in sustained remission for at least 1 year;
* Diagnosis of schizoaffective disorder;
* Bipolar disorder, manic episode, dementia, OCD, or drug-induced psychosis or current major depressive disorder;
* Diagnoses with mental retardation; acute psychosis hospitalization within past 6 months;
* Current clozapine treatment; suicidal ideation or behavior;
* BMI of 39 or greater; current homicidal or violent ideation;
* Medical or CNS condition other than schizophrenia that could affect cognitive performance or testing; relevant drug sensitivity or allergy; positive urine screen for alcohol or drugs of abuse;
* Positive hepatitis or HIV test result;
* Recent clinically significant illness/infection or surgery;
* Recent blood product transfusion, donation or loss of 5 mL/kg of blood;
* Visual, hearing or communication disability

Primary outcomes:
measure: Physical Exams, Brief Neurological Exams, Vitals, Orthostatic Vitals, ECG, Laboratory tests,
timeFrame: Days -1 to 21
measure: Pharmacokinetics; optional CSF for arms 7, 8 & 9
timeFrame: Days -1 to 21
Secondary outcomes:
measure: Extrapyramidal Symptom Rating Scale
timeFrame: Day -1, Day 14
measure: Columbia Suicide Severity Rating Scale
timeFrame: Screening, Day 15
measure: Pharmacodynamics: CANTAB & PANSS
timeFrame: Screening, Day -1, Day 14
measure: Pharmacodynamics: Pittsburgh Sleep Quality Index-Modified
timeFrame: Day -1, Day 15
Other outcomes:
Locations:
Study officials:
References:
citation: Othman AA, Haig G, Florian H, Locke C, Gertsik L, Dutta S. The H3 antagonist ABT-288 is tolerated at significantly higher exposures in subjects with schizophrenia than in healthy volunteers. Br J Clin Pharmacol. 2014 Jun;77(6):965-74. doi: 10.1111/bcp.12281.