louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01065649: Effect of Nortriptyline in Cortical Representation of Heartburn in Nonerosive Reflux Disease (NERD) Patients
Official title: Effect of Nortriptyline in the Cortical Representation of Heartburn in Patients With Nonerosive Reflux Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastroesophageal Reflux Disease
Keywords: reflux disease
heartburn
Lead sponsor: Universidade de Passo Fundo
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2010-02-09
Enrollment: 20
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: Patients with nonerosive reflux disease (NERD) are less responsive to standard treatment with proton pump inhibitors. The hypothesis of this study was that nortriptyline in analgesic doses may decrease heartburn perception and its corresponding cortical activity measured by magnetic resonance image. Therefore, the aim of this study was to assess the cortical representation of heartburn in patients with NERD under treatment with nortriptyline and placebo.


Eligibility criteria: Inclusion Criteria:

* more than 17 years old, heartburn at least twice a week, naive to antireflux medications and antidepressive agents

Exclusion Criteria:

* active esophagitis at endoscopy, contraindications to nortriptyline use

Primary outcomes:
measure: Cortical representation of heartburn
timeFrame: 3 months
Secondary outcomes:
measure: Subjective assessment of heartburn
timeFrame: 3 months
Other outcomes:
Locations:
city: Passo Fundo
country: Brazil
facility: Kozma
state: RS
Study officials:
References:
Clinical trial NCT06971549: Accelerated iTBS for Depression: Monitoring Brain Hemodynamics With Simultaneous iTBS/fNIRS
Official title: Accelerated iTBS for Depression: Monitoring Brain Hemodynamics With Simultaneous iTBS/fNIRS
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Depression
Keywords: Theta-Burst stimulation (iTBS)
Functional near-infrared spectroscopy (fNIRS)
Concurrent TMS/fNIRS
Prefrontal hemodynamic response
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2025-05-14
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will investigate the cortical hemodynamic response variability of an accelerated form of TBS stimulation over left dorsolateral prefrontal cortex (DLPFC) using a concurrent TBS/fNIRS setup. The accelerating TMS protocol that will be used in this study is similar to the Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT), i.e., fifty iTBS sessions (1,800 pulses per session, 50-minute intersession interval) will be delivered as 10 daily sessions over 5 consecutive days at 90% resting motor threshold. The investigators will recruit a depressed patient and conduct a concurrent iTBS/fNIRS protocol for each iTBS session. Moreover, the depression symptoms of the patient will be assessed before and after treatment.


Eligibility criteria: Inclusion Criteria:

* aged 18 to 65;
* a clinical diagnosis of current nonpsychotic major depressive disorder by an experienced psychiatrist according to DSM-IV;
* no or stable (≥2 weeks) psychopharmacological medication;
* have not responded to at least one antidepressant medication;
* have not received any TMS treatment;
* and have a 17-item HAMD score ≥ 20.

Exclusion Criteria:

* severe internal diseases;
* neurological disorders or a history of severe head injuries;
* having suicidal ideation;
* pregnancy;
* common MRI, fNIRS and TMS exclusion criteria, such as a history of brain surgery, head injury, cardiac pacemaker, deep brain stimulation, intracranial metallic particles, history of seizures
* antiepileptics and benzodiazepines corresponding to a dose of \>1 mg lorazepam/d.

Primary outcomes:
measure: Oxygenated and deoxygenated hemoglobin (HbO and HbR) change compared to baseline
timeFrame: Before, during and immediately after the intervention
measure: Hamilton Depression Rating Scale (HAM-D)
timeFrame: through study completion, an average of 5 days
Secondary outcomes:
measure: Montgomery-Asberg depression rating scale (MADRS)
timeFrame: through study completion, an average of 5 days
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: daily for 5 days
measure: Verbal Analogue Scale (VAS) fatigue and pain level
timeFrame: immediately after the intervention
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Hong Kong Polytechnic University
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Georg Kranz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02720549: The Effect of Remote Ischemic Postconditioning on Postoperative Renal Dysfunction in Patients Undergoing Valvular Heart Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Valvular Heart Disease Patients
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2016-03-28
Enrollment: 252
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Ischemic reperfusion injury of cardiopulmonary bypass and postoperative renal dysfunction is a common problem which influence poor outcome in subjects undergoing valvular heart surgery. The incidence of postoperative renal dysfunction was reported as high as 7\~8% in heart surgery using bypass, and is thought to be caused by ischemia/reperfusion injury. Remote ischemic postconditioning was also reported to be protective for ischemic/reperfusion injury in previous animal studies and stoke patients. Therefore, the investigators are trying to evaluate the clinical effect of remote ischemic postconditioning on postoperative renal dysfunction in subjects undergoing valvular heart surgery with bypass.


Eligibility criteria: Inclusion Criteria:

* patients who are undergoing valvular heart surgery
* Adult
* age 19-80

Exclusion Criteria:

* peripheral vascular disease with circulation deterioration
* Renal replacement therapy
* preconditioning medication
* Myocardiac infarction within 3 weeks
* active infective endocarditis
* high dosage steroid therapy
* mental retardation
* unlettered person

Primary outcomes:
measure: incidence of postoperative renal dysfunction using AKIN(acute kidney injury network) criteria
timeFrame: 5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine and Anesthesia
Study officials:
References:
citation: Song JW, Lee WK, Lee S, Shim JK, Kim HJ, Kwak YL. Remote ischaemic conditioning for prevention of acute kidney injury after valvular heart surgery: a randomised controlled trial. Br J Anaesth. 2018 Nov;121(5):1034-1040. doi: 10.1016/j.bja.2018.07.035. Epub 2018 Sep 18.
Clinical trial NCT01479049: The Myocardial Protective Effects of a Moderate-potassium Blood Cardioplegia in Pediatric Cardiac Surgery
Official title: The Myocardial Protective Effects of a Moderate-potassium Blood Cardioplegia in Pediatric Cardiac Surgery：a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congenital Heart Disease
Keywords: congenital heart disease
cardiac surgery
cardiopulmonary bypass
cardioplegia
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2011-11-24
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators previously investigated the cardioprotective effect of an adenosine-lidocaine cardioplegia with moderate-potassium (K+, 10.0 mmol/L) in pediatric cardiac surgery, which was associated with better myocardial protective effects when compared with conventional high-potassium cardioplegia. However, this cardioplegia could not be sucked back into the cardiopulmonary bypass (CPB) circuit because of excessive hemodilution and severe systemic hypotension induced by adenosine. Therefore, the investigators supposed that a moderate-potassium (K+, 10.0 mmol/L) blood cardioplegia without adenosine could also arrest the heart and have better myocardial protective effects compared with conventional hyperkalamic cold blood cardioplegia during cardiac operations without excessive hemodilution and systemic hypotension.


Eligibility criteria: Inclusion Criteria:

* pediatric patients (body weight\<10 kg)
* congenital heart diseases and scheduled for a repair operation with CPB in the Department of Cardiovascular Surgery, Xijing Hospital.

Exclusion Criteria:

* other systemic diseases

Primary outcomes:
measure: post-operative Serum cTnI concentration decreased significantly in 24hours
timeFrame: 24h after myocardial reperfusion
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Department of Cardiovascular Surgery, Xijing Hospital
state: Shaanxi
Study officials:
affiliation: Department of Cardiovascular Surgery, Xijing Hospital
name: Zhenxiao Jin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06918249: Lupine Allergy in Children
Official title: Lupine Allergy in Children: Relevance of Sensitization and Severity of Reaction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Food Allergy in Children
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2025-04-09
Enrollment: 39
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children under 18 years as the study was done in the Pediatric Allergy department

Brief summary: All children sensitized to lupine who have performed an oral food challenge (OFC) to lupine between January 2017 and May 2024 in the Pediatric Allergy Unit of the University Hospital of Nancy were included. Retrospective data regarding food and respiratory allergies were collected as well as information regarding lupine skin prick test (SPT), specific IgE (sIgE) and OFC. Severity of allergic reaction was evaluated by CoFAR grade and reactogenic cumulative threshold dose.

Aims of this study were (i) to assess relevance of sensitization to lupine in children and (ii) to describe severity of reactions in case of allergy.


Eligibility criteria: Inclusion Criteria:

* cutaneous or biological sensitization to lupine

Exclusion Criteria:

* oral food challenge done with something other than lupine flour

Primary outcomes:
measure: diagnostic value of prick test and specific IgE
timeFrame: baseline
Secondary outcomes:
measure: severity of allergic reaction in oral food challenge
timeFrame: baseline
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05714449: OCT Eccentric Fixation and Amblyopia in Children
Official title: OCT Eccentric Fixation, Fixation Stability, and Amblyopia in Children
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Amblyopia
Keywords: eccentric fixation
amblyopia
patching
foveation therapy
OCT
Lead sponsor: State University of New York College of Optometry
Sponsor class: OTHER
First posted: 2023-02-06
Enrollment: 30
Sex: ALL
Minimum age (years): 4
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objectives of this proposal are to characterize the relationship between OCT eccentric fixation (OCT-EF), fixation eye movement (FEM), macular sensitivity in children with amblyopia.

Detailed description: Aim 1. OCT EF changes with patching treatment at 12 weeks visit.

Aim 2. OCT EF changes with foveation therapy.

Eligibility criteria: Inclusion Criteria:

1. children with best-corrected visual acuity (BCVA) of 20/40 (equivalent to 0.3 logMAR) or worse in the amblyopic eye (ranging from 20/40 to 20/400), and interocular difference of BCVA was at least two logMAR lines,
2. ocular causes of amblyopia that were identified as refractive(i.e., anisometropic, strabismus, or strabismic-anisometropic.

   * Anisometropia included interocular difference of spherical equivalent \>=1D or interocular difference of astigmatism cylinder magnitude \>=1D;
   * strabismus included those with deviation \>=10PD or good alignment after prior strabismus surgery;
   * combined type included those who meet the criteria of both anisometropia and strabismus.
   * For the patching group, we will enroll 15 children with strabismic amblyopia who are prescribed patching treatment. Age: 4-12 years old.
   * For the foveation therapy group, we will enroll 15 children with strabismic amblyopia who are prescribed foveation therapies. Age: 8-16 years old.

Exclusion Criteria:

* born before 32 weeks gestational age;
* neurologic, developmental, or systemic illnesses known to be associated with ocular pathologies;
* congenital or acquired macular pathology.

Primary outcomes:
measure: OCT eccentric fixation
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: SUNY College of Optometry
state: New York
Study officials:
affiliation: SUNY College of Optmetry
name: Jingyun Wang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01696149: Effects of High and Low Frequency TENS on Sympathetic Skin Response and Skin Temperature
Official title: The Effects of High and Low Frequency Transcutaneous Electrical Nerve Stimulation on Sympathetic Skin Response and Skin Temperature
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Effects of TENS on Sympathetic Skin Response
Keywords: TENS, sympathetic skin response, skin temperature
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
First posted: 2012-09-28
Enrollment: 15
Sex: ALL
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this study was to determine the effects of 4 Hz and 110 Hz transcutaneous electrical nerve stimulation on the sympathetic nervous system via measuring the sympathetic skin response (SSR) and skin temperature.

Detailed description: 15 healthy subjects (8 females, 7 males) with a mean age of 22.6 ± 3.7 years participated in this study.

All subjects participated, randomly, in a 4 Hz TENS session, a 110 Hz TENS session, and a control (off-TENS) session. Each session consisted of a 20- minute stimulation period and a 10-minute follow up period.

Outcome measures: Sympathetic skin response from the simulated (Right) hand and skin temperature of both stimulated (Right) and none stimulated (Left) hand was measured 15 seconds before, just 15 seconds after, and 10 minutes after application of interventions.

Eligibility criteria: Inclusion Criteria:

* Men and women aged 18 to 30 years

Exclusion Criteria:

* History of cardiovascular, neurologic or musculoskeletal disease
* Taking medication at the time of the study

Primary outcomes:
measure: Changes of sympathetic skin response
timeFrame: 15 seconds before, just 15 seconds after, and 10 minutes after application of interventions
Secondary outcomes:
measure: Changes of skin temperature
timeFrame: 15 seconds before, just 15 seconds after, and 10 minutes after application of interventions
Other outcomes:
Locations:
Study officials:
affiliation: Shiraz University of Medical Sciences
name: Farzaneh Dehghan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00000249: Effects of Subanesthetic Concentrations of Nitrous Oxide - 1
Official title: Effects of Subanesthetic Concentrations of Nitrous Oxide
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Opioid-Related Disorders
Substance-Related Disorders
Keywords: nitrous oxide
subjective effects
healthy volunteer
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 1999-09-21
Enrollment: 10
Sex: ALL
Minimum age (years): 21
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to conduct experiments to examine subjective and reinforcing effects of nitrous oxide. Mood altering and psychomotor effects will be tested on non-drug abusers and preference procedures will be used to assess reinforcing effects. To examine effects of subanesthetic concentrations of nitrous oxide on cold-pressor pain in humans.


Eligibility criteria: Please contact site for information.

Primary outcomes:
measure: Pain intensity
timeFrame: during cold test at 10 min & 30 min of inhalation
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago, Anesthesia & Critical Care
state: Illinois
Study officials:
affiliation: University of Chicago
name: James Zacny, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pharmocol Biochem and Behavior 1995, 51( 2): 323-329
Clinical trial NCT00396149: Safety, Tolerability and Pharmacodynamic Effects of Sublingual Immunotherapy (Tablets) With Recombinant Bet v1
Official title: A Phase I Study to Investigate the Safety, Tolerability and Pharmacodynamic Effects of SLIT(Tablets) With Recombinant Bet v1 Given in Single Rising Doses and in Higher Multi Dose Regimens to Subjects Sensitised to Birch Pollen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Birch Pollen-Related Rhinoconjunctivitis
Rhinitis, Allergic, Seasonal
Keywords: rBet v 1
Birch pollen allergy
Sublingual Immunotherapy
Lead sponsor: Stallergenes Greer
Sponsor class: INDUSTRY
Collaborators: name: Quintiles, Inc.
First posted: 2006-11-06
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the safety and tolerability of successive single rising doses of SLIT in subjects with allergic rhinitis and to investigate the safety and tolerability of multi high dose regimens of SLIT in subjects with allergic rhinitis.


Eligibility criteria: Inclusion Criteria:

* written consent
* Symptoms of birch pollen induced allergic rhinitis for at least the last 2 years.
* Sensitisation to birch pollen as demonstrated with a positive SPT to birch pollen and specific IgE level (birch pollen and r Bet v1) of at least Class 2 at screening.
* FEV1 at least of 80% of predicted values at screening.

Exclusion Criteria:

* Patient who previously received desensitization treatment to birch pollen and/or other betulaceae (e.g., hazel tree, alder...) or who plan to start desensitization treatment during this study.

Primary outcomes:
measure: Local tolerability
timeFrame: Assessed every day over 2 weeks
measure: Global safety
timeFrame: Assessed every day over 2 weeks
Secondary outcomes:
measure: Immunological markers (IgE and IgG4)
timeFrame: Between selection and follow-up visit
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: National University Hospital - Allergy Unit 4222
Study officials:
affiliation: National University Hospital, Copenhagen
name: Hans-Jorgen MALLING, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: L. Winther, L.K. Poulsen, B. Robin, M. Mélac, H. Malling Safety and Tolerability of Recombinant Bet v 1 (rBet v 1) Tablets in Sublingual Immunotherapy (SLIT) The Journal of Allergy and Clinical Immunology February 2009 (Vol. 123, Issue 2, Page S215)
Clinical trial NCT01055249: UVB Model Validation Study
Official title: Single Centre, Subject and Observer Blinded, Placebo Controlled, Cross-over Study of the Effect of Oral Ibuprofen and Topical Hydrocortisone-21-acetate on Ultraviolet Radiation (UVR) Induced Pain and Inflammation in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pain
Inflammation
Healthy Volunteers
Keywords: UVB
pain
inflammation
model
healthy volunteers
Ultraviolet radiation (UVR) induced pain and inflammation in healthy volunteers
Lead sponsor: X-pert Med GmbH
Sponsor class: INDUSTRY
First posted: 2010-01-25
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Single centre, subject and observer blinded, placebo controlled, cross-over study of the effect of oral ibuprofen and topical hydrocortisone-21-acetate on ultraviolet radiation (UVR) induced pain and inflammation in healthy volunteers conducted in two segments and using an intra-individual comparison of application areas.

Detailed description: Single centre, subject and observer blinded, placebo controlled, cross-over study of the effect of oral ibuprofen and topical hydrocortisone-21-acetate on ultraviolet radiation (UVR) induced pain and inflammation in healthy volunteers conducted in two segments and using an intra-individual comparison of application areas.

Subjects that signed the informed consent and are eligible to the study will be irradiated on the back to evaluate their individual minimal erythema doses (MEDs). Read out to determine MED will be done within 24 h after UVR.

A training session (without study medication) using the MED definition areas will be performed in order to introduce subjects to the testing and rating procedures.

Subjects will come in within 14 days of screening to start the first Segment of the study. Eligible subjects will be randomised to receive either:

1. IB 600 mg, applied orally b.i.d., or
2. OP, applied orally b.i.d.

Allocation of topical treatment to these areas will be randomly assigned to:

1. PG, 15 μl/cm2 applied topically b.i.d., or
2. HC, 15 μl/cm2 applied topically b.i.d.

Defined areas will be irradiated with defined dosages of UVR. Assessment of hyperalgesia to heat and signs of inflammation (erythema, skin temperature) for all areas will be performed.

Subjects return within 4 to 11 days to the study site for the second segment of the study. Treatment allocation will be crossed-over and new treatment areas will be selected on the back.

Eligibility criteria: Inclusion Criteria:

* healthy volunteers

Exclusion Criteria:

-

Primary outcomes:
measure: Hyperalgesia to heat
timeFrame: 72 h
Secondary outcomes:
measure: Erythema, Skin temperature
timeFrame: 72 h
Other outcomes:
Locations:
city: Graefelfing
country: Germany
facility: X-pert Med GmbH
state: Bavaria
Study officials:
References: