louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01952626: Prevention of Intrathecal Morphine Induced Pruritus: Comparison of Ondansetron and Palonosetron
Official title: Prevention of Intrathecal Morphine Induced Pruritus: Comparison of Ondansetron and Palonosetron
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Morphine Adverse Reaction
Keywords: intrathecal
morphine
ondansetron
palonosetron
pruritus
Lead sponsor: Kyungpook National University Hospital
Sponsor class: OTHER
First posted: 2013-09-30
Enrollment: 80
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Intrathecal administration of morphine is often used for control of postoperative pain. However, pruritus is one of the most common side effects of intrathecal morphine . Specific serotonin receptor antagonists could be an effective prophylactic treatment of neuraxial opioid-induced pruritus. It was reported that palonosetron is more effective than ondansetron for prevention of postoperative nausea and vomiting. Therefore, the investigators evaluated the efficacy of prophylactic administration of ondansetron and palonosetron for the prevention of intrathecal morphine-induced pruritus.

Detailed description: Intrathecal administration of morphine is often used for relief of postoperative pain. However, pruritus is one of the most common side effects associated with intrathecal morphine. Specific serotonin receptor antagonists such as ondansetron could be an effective prophylactic treatment of neuraxial opioid-induced pruritus. It was reported that palonosetron is more effective than ondansetron for prevention of postoperative nausea and vomiting. Therefore, the investigators evaluated the efficacy of prophylactic administration of ondansetron and palonosetron for the prevention of intrathecal morphine-induced pruritus.

Eligibility criteria: Inclusion Criteria:

* 19-70 years,
* American Society of Anesthesiology physical status 1 and 2
* Scheduled for elective urologic surgery under spinal anesthesia.

Exclusion Criteria:

* Patients with cardiac and psychological problems.
* Patients who take sedatives or narcotics.
* Patient who have allergy to study drugs.

Primary outcomes:
measure: Incidence of pruritus
timeFrame: 24 hours after spinal anesthesia
Secondary outcomes:
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Kyungpook National Hospital
Study officials:
affiliation: Kyungpook National University Hopsital
name: Younghoon Jeon, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02293226: Video-laryngoscopy During Chest Compression
Official title: Comparison of Four Video-laryngoscopes During Pediatric Intubation During Simulated Resuscitation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiac Arrest
Intubation, Endotracheal
Lead sponsor: International Institute of Rescue Research and Education
Sponsor class: OTHER
First posted: 2014-11-18
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The investigators will compare the success rates and time to successful intubation of endotracheal intubation during simulated pediatric and infant resuscitation with and without chest compression using four different video-laryngoscopes.


Eligibility criteria: Inclusion Criteria:

* Give voluntary consent to participate in the study
* Minimum 1 year of work experience in nursing

Exclusion Criteria:

* Not meet the above criteria
* Wrist or low back diseases

Primary outcomes:
measure: Time to intubation
timeFrame: 1 day
Secondary outcomes:
measure: Success of intubation
timeFrame: 1 day
measure: Cormack-Lehan scale
timeFrame: 1 day
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: International Institute of Rescue Research and Education
state: Masovia
Study officials:
affiliation: Institute of Cardiology
name: Lukasz Szarpak
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06345326: Greater Occipital Nerve Block Versus Pulse Radiofrequency in Migraine
Official title: Comparison of the Clinical Effectiveness of Repeated Ultrasound-guided Greater Occipital Nerve Blocks and Greater Occipital Nerve Pulse RF in the Treatment of Migraine
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Migraine
Keywords: migraine
greater occipital nerve block
pulse radiofrequency
Lead sponsor: Adiyaman University Research Hospital
Sponsor class: OTHER
Collaborators: name: Ankara City Hospital Bilkent
First posted: 2024-04-03
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective observational
Primary purpose: TREATMENT

Brief summary: The aim of the study is to evaluate the clinical efficacy of the repeated greater occipital nerve(GON) blokcs with GON pulse radiofreaquency (PRF)

Detailed description: The nerve blocks will be performed at the Cervical-2 (C2) level with ultrasound guidance.Also , the PRF will be done as above proximally.

Eligibility criteria: Inclusion Criteria:

* ICHD- migraine with minimum 4 attacks
* no benefit with proflactic therapies

Exclusion Criteria:

* primary headhache other than migraine according to ICHD
* the change of medical teatment of migrane in last 1 month.

Primary outcomes:
measure: NRS
timeFrame: Before the application then every month following the intervention for 3 months
Secondary outcomes:
measure: Complications
timeFrame: Before the application then every month following the intervention for 3 months
measure: the frequency of headhache
timeFrame: Before the application then every month following the intervention for 3 months
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara City Hospital Bilkent
Study officials:
References:
Clinical trial NCT04612426: the Effectiveness of Brain-computer Interface-pedaling Training System on the Rehabilitation of Stroke
Official title: the Effectiveness of Brain-computer Interface-pedaling Training System on Motor and Cognitive Function Rehabilitation of Stroke Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rehabilitation
Stroke
Brain-computer Interface
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2020-11-03
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Stroke has become the first cause of death and disability among Chinese adults. 70%-80% of patients cannot live independently due to disability, which has brought a heavy burden to families, medical institutions and society. How to better evaluate and improve post-stroke motor and cognitive dysfunction has always been a hot research topic. With the rapid development of brain-computer interface technology, rehabilitation assessment based on quantitative EEG analysis is gradually being applied in the medical field. So we designed a brain-computer interface based on hierarchical task induction-pedaling rehabilitation training system to investigate the effectiveness on the rehabilitation of stroke patients.


Eligibility criteria: Inclusion Criteria:

* Aged 40-80 years old；
* Patients with first ischemic stroke onset from 1 week to 3 months；
* Hemiplegia and cognitive impairment (Mini-Mental State Examination (MMSE) score \<28 or Montreal Cognitive Assessment (MoCA) \<25)；
* Consciousness, sitting balance level 1 or above, can cooperate with assessment and treatment;
* The patient or its authorized agent signs the informed consent form.

Exclusion Criteria:

* Severely impaired cognition, unable to pay attention to and understand screen information;
* Severe pain and limited mobility of lower extremity.

Primary outcomes:
measure: The change of Fugl-Meyer motor function score of lower limbs
timeFrame: Two weeks after enrollment.
Secondary outcomes:
measure: Attention index
timeFrame: Two weeks after enrollment.
measure: Digital Span Test (DST)
timeFrame: Two weeks after enrollment.
measure: Symbol Digit Modalities Test (SDMT)
timeFrame: Two weeks after enrollment.
Other outcomes:
Locations:
city: Xi'an
country: China
facility: First Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
Study officials:
References:
citation: Yuan Z, Peng Y, Wang L, Song S, Chen S, Yang L, Liu H, Wang H, Shi G, Han C, Cammon JA, Zhang Y, Qiao J, Wang G. Effect of BCI-Controlled Pedaling Training System With Multiple Modalities of Feedback on Motor and Cognitive Function Rehabilitation of Early Subacute Stroke Patients. IEEE Trans Neural Syst Rehabil Eng. 2021;29:2569-2577. doi: 10.1109/TNSRE.2021.3132944. Epub 2021 Dec 21.
Clinical trial NCT06871826: Tissue Inhibitor of Metalloproteinases 2 Level in Patients Undergoing Cardiac Surgery
Official title: Tissue Inhibitor of Metalloproteinases 2 Level Predicts Acute Kidney Injury in Patients Undergoing Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Acute Kidney Injury
Extracorporeal Circulation; Complications
Surgery
Lead sponsor: Wuhan University
Sponsor class: OTHER
First posted: 2025-03-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: TIMP2 level
Primary purpose: OTHER

Brief summary: Acute kidney injury (AKI) is one of the most frequent major complications in patients undergoing cardiac surgery. CSA-AKI is independently related to increased perioperative mortality, increased hospital and ICU length of stay as well as heath care expenditure. Identification of relevant biomarkers may lead to early diagnosis and improve patient outcomes and health care costs. The pathophysiology of CSA-AKI is complex and ischemia-reperfusion injury is one of the important factors. Recently, it has been shown that Tissue Inhibitor of Metalloproteinases 2 (TIMP2) is associated with ischemia-reperfusion injury. In this study, relationship between TIMP2 with the risk of CSA-AKI was analyzed and the predictive value of elevated level of TIMP2 for early prediction of CSA-AKI was further evaluated.


Eligibility criteria: Inclusion Criteria:

* Patients (≥18 years old) underwent on-pump cardiac surgery
* admitted to ICU immediately after surgery

Exclusion Criteria:

* Patients younger than 18 years
* with prior AKI
* end-stage kidney disease
* need for chronic hemodialysis
* pregnant patients
* unable to give written consent for participation

Primary outcomes:
measure: the development of CSA-AKI
timeFrame: 1 Week
Secondary outcomes:
measure: AKI severity
timeFrame: 1 Week
measure: need for RRT
timeFrame: 1 Week
measure: duration of AKI (≥7 days)
timeFrame: 1 Week
measure: length of ICU stay
timeFrame: up to 28 days
measure: post-operative hospital stay
timeFrame: up to 28 days
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Zhongnan Hospital
state: Hubei
Study officials:
References:
Clinical trial NCT01995526: A Study of Insulin Peglispro in Healthy Male Japanese Participants
Official title: A Single Dose Study to Evaluate the Pharmacokinetics and Glucodynamics of Insulin Peglispro (LY2605541) in Healthy Male Japanese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2013-11-26
Enrollment: 11
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The main purpose of this study is to evaluate how the body processes the study drug known as insulin peglispro and how the study drug affects blood sugar in healthy male Japanese participants. This study will also evaluate safety of the study drug. The study will last up to 46 days for each participant, not including screening.


Eligibility criteria: Inclusion Criteria:

* Participants are overtly healthy male Japanese.
* Participants have Body Mass Index (BMI) between 18.5 and 25.0 kilograms per square meter (kg/m\^2), inclusive.

Exclusion Criteria:

* Participants have known allergies to insulin peglispro or related compounds.
* Participants have a fasting venous blood glucose \>108 milligrams per deciliter (mg/dL) (\>6 millimoles per liter \[mmol/L\]).

Primary outcomes:
measure: Pharmacokinetics: Observed Maximum Concentration (Cmax) of Insulin Peglispro
timeFrame: Predose and 2, 4, 8, 12, 24, 30, 36, 48, 96, 144, and 192 hours postdose
measure: Pharmacokinetics: Area Under the Concentration Curve (AUC) of Insulin Peglispro
timeFrame: Predose and 2, 4, 8, 12, 24, 30, 36, 48, 96, 144, and 192 hours postdose
measure: Pharmacokinetics: Time of Maximum Observed Drug Concentration (Tmax) of Insulin Peglispro
timeFrame: Predose and 2, 4, 8, 12, 24, 30, 36, 48, 96, 144, and 192 hours postdose
measure: Glucodynamics: Maximum Glucose Infusion Rate (Rmax)
timeFrame: Predose up to 36 hours post clamp procedure
measure: Glucodynamics: Total Amount of Glucose Infused (Gtot)
timeFrame: Predose up to 36 hours post clamp procedure.
Secondary outcomes:
Other outcomes:
Locations:
city: Fukuoka
country: Japan
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT04986826: Exercise Effect on Transthyretin Stability
Official title: Exercise Effect on Transthyretin Stability in Master Athletes and Patients With Transthyretin Amyloidosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Amyloidosis Transthyretin
Athlete Heart
Keywords: exercise
amyloidosis
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2021-08-03
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Master athletes without evidence of transthyretin amyloidosis. Genotype positive phenotype negative transthyretin amyloidosis, and phenotype positive transthyretin amyloidosis.

Brief summary: The goal of this study to investigate if exercise predisposes to transthyretin instability. The investigators will evaluate the effect of exercise on transthyretin biochemistry.

Detailed description: This is an investigator initiated observational study, designed to study the effect of exercise on transthyretin stability in three main populations: Group 1: healthy master athletes who are 60 years or older. Group 2: Genotype positive (G+) cardiac phenotype negative (P-) patients with variant ATTR (i.e. carriers without evidence of disease). Group 3: Patients with ATTR CA who have not been on a stabilizer (tafamidis) within the last 14 days prior to enrollment.

Eligibility criteria: Inclusion Criteria:

General inclusion criteria: patients should be able to exercise on a treadmill or a bike, willing to consent to the study procedures and willing to return to site during the follow up period of 72 hours for repeated blood and urine collection

Specific inclusion criteria:

* Group 1: Subjects must be at least 60 years of age and meet the master athlete definition of: athletes engaged in cycling ≥8 hours per week or running ≥6 hours per week or triathlon training (combination of swimming, cycling, running) ≥8 hours per week, or equivalent sports activities, for at least 6 months prior to enrollment.
* Group 2: Genotype positive (G+) cardiac phenotype negative (P-) patients with variant ATTR (i.e. carriers without evidence of disease)
* Group 3: Patients with ATTR CA who have not been on a stabilizer (tafamidis) within the last 14 days prior to enrollment.

Exclusion Criteria:

Taking diflunisal or daily non-steroidal anti-inflammatory drugs (NSAIDs) use within 2 weeks.

Primary outcomes:
measure: Change in percent transthyretin stability assay
timeFrame: Change from baseline to 72 hours post-exercise
Secondary outcomes:
measure: Plasma transthyretin level
timeFrame: Change from baseline to 72 hours post-exercise
measure: Plasma transthyretin fragments
timeFrame: Change from baseline to 72 hours post-exercise
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
References:
Clinical trial NCT02832726: TRIM: Danish Form and Dose Study on Vitamin B12
Official title: TRIM: Danish Form and Dose Study in Vitamin B12
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: absorption of Vitamin B12
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2016-07-14
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The study investigates the absorption of different doses of hydroxocobalamin and cyanocobalamin in a vitamin B12-replete Danish population.


Eligibility criteria: Inclusion Criteria:

* At least 18 years old

Exclusion Criteria:

* Use of vitamin pills with vitamin B12 within the last two weeks of the study
* Treatment with vitamin B12 injections within the last year
* Known chronic systemic disease
* Not able to give informed consent.

Primary outcomes:
measure: Vitamin B12 absorption (increase in holotranscobalamin)
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Greibe E, Mahalle N, Bhide V, Heegaard CW, Naik S, Nexo E. Increase in circulating holotranscobalamin after oral administration of cyanocobalamin or hydroxocobalamin in healthy adults with low and normal cobalamin status. Eur J Nutr. 2018 Dec;57(8):2847-2855. doi: 10.1007/s00394-017-1553-5. Epub 2017 Oct 16.
Clinical trial NCT02252926: Local Anesthetic Treatment of Oral Pain in Patients With Mucositis
Official title: Clinical Trial With Lozenges as Local Anesthetic Treatment for Head/Neck Cancer Patients With Oral Mucositis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Mucositis
Keywords: Anesthetics, Local
Bupivacaine
Lozenge
Administration, Topical
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
Collaborators: name: Moberg Pharma, Sweden
First posted: 2014-09-30
Enrollment: 70
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: SUPPORTIVE_CARE

Brief summary: Oral mucositis is a damage to the mucosa of the oral cavity and pharynx. It is a serious and painful adverse effect caused by the radio therapy and/or chemo therapy patients with head and neck cancer receive. The pain caused by oral mucositis can be difficult to treat as the current treatment with opioids is not sufficient and can cause adverse effects.

Our hypothesis is that treatment with a local anesthetic lozenge with bupivacaine can reduce the oral pain caused by mucositis compared with the current standard treatment.


Eligibility criteria: Inclusion Criteria:

* diagnosed with head/neck cancer and starting radio therapy treatment
* age between 18 and 80 years (both included)
* able to talk, read and understand Danish
* ability to give informed consent

Exclusion Criteria:

* known hypersensitivity towards bupivacaine or other local anesthetics of the amide type
* pregnancy
* women breastfeeding a child

Primary outcomes:
measure: Reduction of oral and pharyngeal pain measured on Visual Analogue Scale (VAS)
timeFrame: 7 days
Secondary outcomes:
measure: Duration of the effect of the lozenge
timeFrame: 7 days
measure: Effect of the bupivacaine lozenge
timeFrame: 7 days
measure: Safety: Peak plasma concentrations of bupivacaine
timeFrame: 90 minutes
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Oncology, Rigshospitalet
city: Herlev
country: Denmark
facility: Department of Oncology, Herlev Hospital, Denmark
Study officials:
affiliation: Department of Oncology, Rigshospitalet, Denmark
name: Claus A Kristensen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Oncology Herlev Hospital, Denmark
name: Jens Bentzen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mogensen S, Treldal C, Kristensen CA, Bentzen J, Lawson-Smith L, Petersen J, Andersen O. Effect of bupivacaine lozenges on oral mucositis pain: a randomized controlled multicenter phase II study. Pain Rep. 2017 Aug 23;2(5):e619. doi: 10.1097/PR9.0000000000000619. eCollection 2017 Sep.