louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00562211: Efficacy of a New Topical Anesthetic
Official title: A Single-blind, Randomized, Controlled Trial to Assess the Efficacy of a New Topical Anesthetic in Reducing Pain Associated With Venipuncture in Children.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Pain
Keywords: children
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2007-11-21
Enrollment: 40
Sex: ALL
Minimum age (years): 12
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A new topical anesthetic which contains 5% lidocaine and a disinfection ingredient has been developed and is tested in this study (LidoDyn).

The study examines the efficacy of LidoDyn by comparing it with an already proven anesthetic agent (EMLA crème).


Eligibility criteria: Inclusion Criteria:

* Previously healthy children of whom venipuncture is needed to be performed.

Exclusion Criteria:

* History of allergic reaction to any local anesthetic.
* History of chronic disease
* Patient's condition requires urgent treatment (e.g. severe dehydration, shock)
* Active local skin infection or skin pathologic condition at the antecubital fossa
* Tattoo, surgical scar or skin condition that might interfere with skin sight assessment.
* Patient undergone venipuncture at the antecubital fossa within the pror two weeks.
* Uncooperative or exceptionally anxious patient.

Primary outcomes:
measure: Self report assessment of pain (using the Visual Analog Scale)
timeFrame: 60 Min+ 5-10 Min
Secondary outcomes:
measure: Medical staff observational assessment of pain (in a scale of 0 to 10)
timeFrame: 60 Min + 5-10 Min
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Emergency Department of the Meyer Children Hospital, Rambam Health Care Campus
Study officials:
affiliation: Rambam Health Care Campus
name: Itai Shavit, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Rambam Health Care Campus
name: Hadas Knaani-Levinz, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Rambam Health Care Campus
name: Amir Hadash, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06637111: Ultrasound Guidance of Office Hysteroscopy in Patients With History of Failure of Office Hysteroscopy Due to Cervical Stenosis.
Official title: Ultrasound Guidance of Office Hysteroscopy in Patients With History of Failure of Office Hysteroscopy Due to Cervical Stenosis.A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hysteroscopy
Keywords: Hysteroscopy
Ultrasound
Pain
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Bedaya Hospital
First posted: 2024-10-15
Enrollment: 58
Sex: FEMALE
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: The study is conducted to assess whether ultrasound guidance can facilitate the access of the office hysteroscope into the uterine cavity of patients with previous failure of office hysteroscopy due to cervical stenosis.


Eligibility criteria: Inclusion Criteria:

* Patients with history of failure of office hysteroscopy

Exclusion Criteria:

* Pelvic inflammatory disease
* Severe vaginal bleeding
* Pregnancy
* Allergy to lidocaine, prilocaine or diclofenac potassium

Primary outcomes:
measure: Success of office hysteroscopy [ ability to gain access of the hysteroscope into uterine cavity]
timeFrame: Immediately after the procedure
Secondary outcomes:
measure: Intensity of pain
timeFrame: Immediately after the procedure
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of medicine, Cairo university
city: Cairo
country: Egypt
facility: Obstetrics &Gynecology Department , Faculty of medicine ,Cairo university
Study officials:
affiliation: Cairo University
name: Usama M Fouda
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kresowik JD, Syrop CH, Van Voorhis BJ, Ryan GL. Ultrasound is the optimal choice for guidance in difficult hysteroscopy. Ultrasound Obstet Gynecol. 2012 Jun;39(6):715-8. doi: 10.1002/uog.11072.
Clinical trial NCT02273011: Combined Spinal-epidural Versus Spinal Analgesia for Elective Caesarean Section in the Postoperative Period
Official title: Combined Spinal-epidural Versus Spinal Analgesia for Elective Caesarean Section in the Postoperative Period
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Satisfaction
Pain
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2014-10-23
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: healthy parturients scheduled for elective caesarean section

Brief summary: Combined spinal epidural (CSEA) and single shot spinal anesthesia (SSSA) are both well-established anesthetic methods for caesarean section. CSEA combines the advantages of spinal anesthesia for the surgery, and epidural anesthesia for postoperative pain management. The aim of this randomized trial was to compare analgesia and patient satisfaction with CSEA continuous epidural administration of local anesthetics versus SSSA with oral pain medication in the postoperative period.

Detailed description: Combined spinal epidural (CSEA) and single shot spinal anesthesia (SSSA) are both well-established anesthetic methods for caesarean section. CSEA combines the advantages of spinal anesthesia for the surgery, and epidural anesthesia for postoperative pain management. However, it is more time-consuming, and adds potentially risks of both single techniques.

The aim of this randomized trial was to compare analgesia and patient satisfaction with CSEA continuous epidural administration of local anesthetics versus SSSA with oral pain medication in the postoperative period.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists-physical status: I or II
* elective caesarean section

Exclusion Criteria:

* age under eighteen
* maternal systemic diseases
* allergies against the drugs used
* systemic infection or local infection in the puncture area
* dysfunctional coagulation
* coagulation-inhibiting drugs

Primary outcomes:
measure: patient's satisfaction
timeFrame: perioperative
Secondary outcomes:
measure: additional oral pain medication
timeFrame: perioperative
measure: pain score
timeFrame: perioperative
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
Study officials:
affiliation: Universitätsklinukum Hamburg-Eppendorf
name: Daniel Reuter
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05382611: miRNA in Patients With Thoracic, Abdominal and Intracranial Aneurysms
Official title: miRNA in Patients With Thoracic, Abdominal and Intracranial Aneurysms
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vascular Aneurysm
Keywords: miRNA
Lead sponsor: Na Homolce Hospital
Sponsor class: OTHER
Collaborators: name: Czech Academy of Sciences
First posted: 2022-05-19
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study group will be made up of 50 subjects followed for the diagnosis of AAA or TAA and 20 patients with intracranial aneurysm. The control group comprises 20 subjects in total and will be made up of patients who are treated for lipid metabolism disorder

Brief summary: To assess the expression of miRNA in patients with TAA, AAA in aneurysmatic tissue and to compare this expression with the healthy tissue in the same patient.

In the same cohort, to asses the presence of miRNA in plasma and to compare with the control group.

Over the period of three years,to follow subjects in order to assess if the presence of certain miRNAs speeds up or slows down the progression of disease.

In patients with intracranial aneurysms to detect miRNA in plasma especially in patients with familial occurrence.

Detailed description: MicroRNAs constitute a recently discovered class of non-coding RNAs that play key roles in the regulation of gene expression. Acting at the post-transcriptional level, MicroRNAs have been shown to be involved in a wide range of biological processes such as cell cycle control, apoptosis and several developmental and physiological processes including stem cell differentiation, hematopoiesis, hypoxia, cardiac and skeletal muscle development. In addition to their important roles in healthy individuals, microRNAs have also been implicated in a number of diseases including a broad range of cancers, cardiovascular and heart disease. Their different expression in aortic tissue in patients with aortic abdominal aneurysm and their association with the progression of the disease were confirmed. They represent the potential target for the treatment of the disease. MiRNA act as biomarkers showing the potential risk of the presence of TAA, AAA and intracranial aneurysm, for the prediction of TAA and AAA progression and for the discovery of new treatment possibilities.

Eligibility criteria: Inclusion Criteria:

1. 18 years of age or older
2. Patient willing and able to sign clinical trial Informed Consent
3. Patient with AAA or TAA who require an open surgical procedure, or patient with intracranial aneurysm indicated for radiological intervention

Exclusion Criteria:

1. Patient with multiorgan failure

Primary outcomes:
measure: The comparison of miRNA in healthy and aneurysmatic tissue
timeFrame: 2020 at end of trial
Secondary outcomes:
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Na Homolce Hospital
Study officials:
References:
Clinical trial NCT02206711: Study of the Absorption, Metabolism, and Route of Elimination of a Novel Class of Anti-HIV 1 Drugs (BMS-955176) in Humans.
Official title: Pharmacokinetics and Metabolism of [14C] BMS-955176 in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infections
Lead sponsor: ViiV Healthcare
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2014-08-01
Enrollment: 21
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to assess the pharmacokinetics (PK), metabolism, routes and extent of elimination, safety and tolerability of a single oral dose of \[14C\] BMS-955176 in healthy male subjects. There is no formal research hypothesis to be statistically tested for this study.


Eligibility criteria: Inclusion Criteria:

* Healthy Male subjects
* Ages 18-50 years
* Body weight of at least 110 lbs (50kg)
* BMI of 18 to 32 kg/m\^2
* non-smoking

Exclusion Criteria:

* Clinically significant diagnostic or therapeutic radiation exposure within the previous 12 months (eg serial X-ray or CAT scans, barium meals).
* gastrointestinal disease including gastrointestinal surgery
* constipation or irregular bowel movements

Primary outcomes:
measure: To asses the PK (AUC, Cmax) of a single oral dose
timeFrame: Day 1 through Day 13 (predose to 288 hours)
measure: To estimate extent of elimination of a single oral dose (% TRA recovery)
timeFrame: Day 1 through Day 13 (predose to 288 hours)
Secondary outcomes:
measure: Safety Assessment
timeFrame: Day 1 through Day 13
Other outcomes:
Locations:
city: Madison
country: United States
facility: GSK Investigational Site
state: Wisconsin
Study officials:
affiliation: ViiV Healthcare
name: Viiv Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT03404011: Acute Effects of Propylene Glycol/Glycerol Intake on Blood Parameters
Official title: Acute Effects of Propylene Glycol/Glycerol Intake on Cardiorespiratory Blood Parameters
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Complication
Lead sponsor: Université Libre de Bruxelles
Sponsor class: OTHER
First posted: 2018-01-19
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this study is to evaluate the acute effect of propylene glycol and glycerol intake on cardiorespiratory blood parameters.

Detailed description: Background : Propylene glycol/glycerol intake is increasingly popular. Acute effect of propylene glycol and glycerol intake on cardiorespiratory blood parameters is unknown. The investigators postulate that intake of propylene glycol and glycerol could modifiy cardiorespiratory blood parameters.

Aims of this study : to test the following hypotheses :

1) Acute intake of propylene glycol and glycerol modifies cardiorespiratory blood parameters.

To test this hypothesis, we will perform blood samples before and after intake of propylene glycol and glycerol. Participants will be tobacco smoker between 18 and 70 years old, with multiple cardiovascular risk factors, and who will undergo a cardiac catherization. After the cardiac catherization, the catheter will be used to perform serial blood samples.

Eligibility criteria: Inclusion Criteria:

* Subject undergoing cardiac catherization
* Subject must be an active tobacco smoker

Exclusion Criteria:

* Symptoms of infection or inflammation
* Acute disease including heart rhythm disorder, acute coronary syndrome or decompensation of a chronic disease (heart failure, COPD,...)
* Unexpected and undesirable effects during the cardiac catherization procedure
* Respiratory failure requiring supplementary oxygen

Primary outcomes:
measure: Cardiorespiratory biological variables
timeFrame: 5 minutes
Secondary outcomes:
measure: Cardiorespiratory biological variables
timeFrame: 20 minutes
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Saint-Pierre Hospital
Study officials:
affiliation: Université Libre de Bruxelles
name: Martin Chaumont, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05760911: Myopia Prevention Through Monitoring and Motivating Outdoor Activities With Smartwatches
Official title: A Multi-center Clinical Study on the Myopia Prevention by Monitoring and Motivating Outdoor Activities With Smartwatches
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Myopia, Progressive
Lead sponsor: Shanghai Eye Disease Prevention and Treatment Center
Sponsor class: OTHER
Collaborators: name: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
First posted: 2023-03-09
Enrollment: 1200
Sex: ALL
Minimum age (years): 4
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this multi-center, randomized, parallel-controlled clinical trial is to evaluate the effectiveness of outdoor activities monitoring and motivating by smartwatches to prevent myopia progression in children. The main question it aims to answer are:

1. To evaluate the two-year change of spherical equivalent progression.
2. To evaluate the change in axial length, the incidence of myopia, the time of outdoor activity, the choroid thickness, and blood flow through the two-year intervention.

Participants will wear smartwatches and receive Mini Program outdoor activity reminders and motivations. The required outdoor activity time is 2 hours from Monday to Friday and more than 2 hours on weekends. The control group will only wear smartwatches for monitoring. Researchers will compare the control group and the intervention group to see if outdoor activities can protect myopia or not.


Eligibility criteria: Inclusion Criteria:

1. Gender is not limited;
2. Age: 4 \~ 9 years old;
3. Spherical equivalent: -0.5D \< SE \< 2.5D;
4. Be able to follow up for at least 2 years;
5. Be able to wear a smartwatch on a daily basis as required;
6. Parents or guardians sign an informed consent form;
7. Children over 6 years old need oral consent to participate.

Exclusion Criteria:

1. Anisometropia \> 1.50D;
2. Using other interventions for controlling myopia including atropine, rigid orthokeratology lenses, bifocal lenses or progressive lenses, red light, acupuncture, etc.;
3. Strabismus and/or amblyopia;
4. Previous history of eye surgery (including strabismus correction);
5. Ocular or systemic diseases that may be related to the development of myopia or myopia: such as Marfan syndrome, neonatal retinopathy, diabetes, etc.;
6. Other circumstances that the investigator judges inappropriate to participate in the trial.

Primary outcomes:
measure: The change of spherical equivalent
timeFrame: Two years
Secondary outcomes:
measure: The change of axial length
timeFrame: Two years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00079911: A Clinical Research Study For The Suppression And Treatment Of Genital Herpes Infection In HIV-Infected Persons
Official title: An International, Randomized, Double-Blind, Placebo-Controlled Study of Valaciclovir for the Suppression and Episodic Treatment of Genital HSV Infection in HIV-Infected Persons With CD4+ Lymphocyte Count <100 Cells/mm3.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Herpes Genitalis
Keywords: Herpes
Genital Herpes
HIV
HSV
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2004-03-19
Enrollment: 7
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: This clinical research study will be an international trial evaluating the safety and effectiveness of a marketed drug compared to placebo (like a sugar pill) for the suppression of repeated genital herpes infections in HIV-infected subjects with CD4+ count \<100 cells/mm3.


Eligibility criteria: Inclusion Criteria:

* CD4+ lymphocyte count \<100cells/mm3 at the screening visit.
* Documented history of HIV infections
* Must have received stable, combination anti HIV drugs for at least 4 months immediately prior to participation, and per the investigator, are unlikely to require change in anti-HIV drugs during the six-month study.
* Laboratory confirmation of genital herpes (a positive Herpes Simplex Virus-2 antibody test).
* 3 or more outbreaks of genital herpes in the previous 12 months if not on genital herpes medicines currently.
* 3 or more outbreaks of genital herpes per year in the period prior to beginning of treatment for chronic genital herpes.

Exclusion Criteria:

* Kidney diseases.
* Liver diseases.
* Known allergic reactions to VALTREX (valaciclovir), ZOVIRAX (acyclovir), FAMVIR (famciclovir), or CYTOVENE (ganciclovir).
* Vomiting syndrome.
* Must be willing to discontinue taking current genital herpes medicines 1 week prior to participation.
* Active AIDS-indicator conditions, as defined by CDC Category C.
* Other protocol inclusion and exclusion criteria to be evaluated by the research physician.

Primary outcomes:
measure: Adverse Events
timeFrame: Up to 6 months
Secondary outcomes:
measure: Proportion of recurrence of genital HSV
timeFrame: Up to 6 months
measure: Time to first culture-positive recurrence of genital HSV
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Altamonte Springs
country: United States
facility: GSK Investigational Site
state: Florida
city: Chicago
country: United States
facility: GSK Investigational Site
state: Illinois
city: Boston
country: United States
facility: GSK Investigational Site
state: Massachusetts
city: Darlinghurst
country: Australia
facility: GSK Investigational Site
state: New South Wales
city: Kowloon Bay
country: Hong Kong
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT03391128: Circulating P3NP and Cardiovascular Events in Hemodialysis Patients
Official title: Involvement of Circulating Aminoterminal Propeptide of Type 3 Procollagen in Cardiovascular Events in Patients on Hemodialysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Events
Cardiac Fibrosis
Lead sponsor: Toujinkai Hospital
Sponsor class: OTHER
First posted: 2018-01-05
Enrollment: 244
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Of 302 patients who met the inclusion criteria, 58 patients were excluded based on the exclusion criteria. Consequently, 244 patients (126 men and 118 women; mean age, 64 ± 11 years; dialysis duration, 11.5 ± 7.8 years) were enrolled in the study.

Brief summary: This study evaluates whether circulating levels of aminoterminal propeptide of type III procollagen (PIIINP) can predict the cardiovascular events in hemodialysis patients.

Detailed description: Type III collagen abundantly exists in the cardiovascular system including the aorta and heart. The aminoterminal propeptide of type III procollagen (PIIINP) is an extension peptide of type III procollagen, which is cleaved off stoichiometrically during conversion from type III procollagen to type III collagen and liberated to serum. Elevated serum concentrations of PIIINP are considered a marker of higher collagen turnover and tissue fibrosis including the heart and vascular system. In this study, the investigators prospectively examined whether serum levels of PIIINP could be a biomarker for predicting cardiovascular events in hemodialysis patients.

Eligibility criteria: Inclusion Criteria:

* End-stage kidney disease patients who had been undergoing maintenance hemodialysis over one year in Toujinkai Hospital at the point of January 1, 2005

Exclusion Criteria:

* Histories of coronary events and/or interventions
* Congestive heart failure of New York Heart Association grades III to IV
* Moderate or worse valvular heart disease
* Permanent pacemaker implantation
* Idiopathic cardiomyopathy
* Chronic obstructive pulmonary disease
* Malignancy
* Acute hepatitis, chronic hepatitis, or liver cirrhosis including carrier of hepatitis virus

Primary outcomes:
measure: Cardiovascular events
timeFrame: January 1, 2005 to January 31, 2011
Secondary outcomes:
Other outcomes:
Locations:
city: Kyoto
country: Japan
facility: Toujinkai Hospital
Study officials:
affiliation: Tojinkai Hospital
name: Masato Nishimura, MD
role: PRINCIPAL_INVESTIGATOR
References: