louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03647579: Dexmedetomidine Versus Midazolam Added to Ketamine in Pediatric Patients Undergoing Bone Marrow Aspiration and Biopsy
Official title: Effect of Single Dose Dexmedetomidine Versus Midazolam on Emergence Agitation and Recovery Profile When Added to Ketamine for Procedural Sedation and Analgesia in Pediatric Patients Undergoing Bone Marrow Aspiration and Biopsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Procedural Sedation and Analgesia During Bone Marrow Aspiration and Biopsy
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-08-27
Enrollment: 100
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Group I :The patients will receive midazolam intravenously (i.v.) in a dose of 0.05 mg/kg diluted by 50ml saline over 10 minutes using syringe pump plus 1 mg/kg ketamine (iv).

Group II : The patients will receive Dexmedetomidine intravenously (i.v.) in a dose of 2mic/kg diluted by 50ml saline over 10 minutes using syringe pump plus 1 mg/kg ketamine (iv).

The objective of this study to evaluate the clinical effects, adverse effects and recovery time of two different sedative agents (midazolam and Dexmedetomidine) combined with ketamine during conscious sedation for child patient with haematological cancer undergoing BMA \&biopsy.


Eligibility criteria: Inclusion Criteria:

* All consecutive children with acute lymphoblastic leukemia undergoing bone marrow aspiration and biopsy.

Exclusion criteria:

* previous sensitization or anaphylactic reaction to Dexmedetomidine, ketamine,and midazolam;
* evidence of head injury,
* raised intracranial or intraocular tension;
* use of drugs known to interact with either study agent;
* an American Society of Anesthesiologists (ASA) physical status score greater than 2.
* Also Patients with cardiovascular, respiratory, hepatic diseases and epilepsy will be excluded.

Primary outcomes:
measure: efficacy of drug mixture on procedural sedation and analgesia: Ramsay sedation score
timeFrame: within the time of the procedure of bone marrow aspirate and biopsy
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: South Egypt Cancer Institute, Assiut University
Study officials:
References:
Clinical trial NCT06527079: Evaluation of Clinical Decision Support in Opioid Tapering
Official title: Evaluation of Clinical Decision Support in Opioid Tapering
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Medication Abuse
Harm Reduction
Opioid Use Disorder
Opioid Prescribing
Opioid Overdose
Prevention
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: National Institutes of Health (NIH)
First posted: 2024-07-30
Enrollment: 200000
Sex: ALL
Minimum age (years): 12
Maximum age (years): 89
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Residents and visitors to the state of Colorado who seek healthcare within the University of Colorado Health (UCHealth) primary care system receiving long-term opioid treatment.

Brief summary: The 2022 Center for Disease Control and Prevention (CDC) clinical practice guideline for prescribing opioids for pain recommends that when tapering a patient's opioid dose, doses should be decreased at a slow rate to reduce the risk of withdrawal symptoms, overdose, and to promote tolerance of the tapering. This project will evaluate a clinical decision support (CDS) tool in the form of a clinical care pathway that gives providers information, recommendations, and educational material on strategies for opioid tapering. Primary care providers will be randomized at the clinic location to a control arm or intervention arm. The control arm will have the clinical care pathway available, but will not be reminded of the pathway when tapering a patient. The intervention arm will receive a nudge when prescribing a tapering opioid strategy to a patient to use the clinical care pathway. The rate of opioid tapering in line with CDC guidelines will be examined as well as long-term patient outcomes of opioid overdose or poisoning using existing patient health records. The study period will be approximately 18 months.


Eligibility criteria: Inclusion Criteria: Primary care patients being tapered from an opioid. Tapering patients:

* Have an active opioid prescription for more than 3 months and
* Prescribed more than 90 morphine milligram equivalents (MME) per day or
* Co-prescribed an opioid and benzodiazepine or
* Received a reduction in opioid dosage by more than 5% MME per day

Exclusion Criteria:

* Patients \<12 and \>89
* Patients with active cancer diagnosis in last 1 year
* Patients with hospice care/palliative care order
* Patients with sickle cell disease diagnosis

Primary outcomes:
measure: Percentage of encounters tapering within CDC guidelines
timeFrame: 18 months
Secondary outcomes:
measure: Clinical decision support (CDS) acceptance rate
timeFrame: 18 months
measure: Subsequent opioid overdose/poisoning rates
timeFrame: 6 months after taper encounter
measure: Health care utilization
timeFrame: 6 months after taper encounter
Other outcomes:
Locations:
Study officials:
affiliation: University of Colorado, Denver
name: Jason Hoppe, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00258479: Safety of Combining Modafinil and Nicotine Replacement Therapy in Treating Nicotine Dependent Adolescents
Official title: Modafinil and Nicotine in Adolescents: Phase I Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Tobacco Use Disorder
Keywords: Nicotine Dependence
Nicotine Use Disorder
Tobacco Dependence
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2005-11-24
Enrollment: 24
Sex: ALL
Minimum age (years): 16
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: Nicotine is one of the most widely abused substances in the United States. Nicotine replacement therapy (NRT) is currently an effective treatment for nicotine dependence; however, even with NRT most people fail at quitting smoking after their first attempt. Modafinil is a promising drug that may be useful in treating nicotine dependent individuals. The purpose of this study is to evaluate the safety of the combination of modafinil and NRT in treating nicotine dependent adolescent smokers.

Detailed description: NRT is a critical part of treating nicotine withdrawal symptoms, such as cravings, sleeplessness, poor concentration, and anxiety. The addition of modafinil, a promising pharmacologic agent, may enhance the effectiveness of NRT by further reducing inattention and depressed mood. The purpose of this study is to examine the safety of using both modafinil and NRT in treating nicotine dependent adolescents. In addition, this study will examine the effects of modafinil and NRT, alone and in combination, on alleviating symptoms of inattention and depressed mood.

Participants in this 12-day dose escalation study will be tested under eight different dose conditions. Modafinil and NRT will first be tested alone; participants will be exposed to low doses prior to higher doses of medication. Various modafinil-NRT dose combinations will then be tested. Modafinil will be administered at 5 p.m. each day, and NRT will be self-administered at the start of each day in which a participant must complete lab tests. The following measures will be obtained at study visits occurring before and after the various modafinil-NRT dose combinations: nicotine withdrawal symptoms, medication side effects, activity level, cardiovascular response, and profile of mood states (POMS).

Eligibility criteria: Inclusion Criteria:

* Smokes 10 or more cigarettes per day

Exclusion Criteria:

* Current use of any medication for a psychiatric disorder
* Positive drug screen test
* Uses smokeless tobacco

Primary outcomes:
measure: Safety of combination drug treatment and physiological response; measured after treatment with each dose combination
timeFrame: laboratory session
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Catherine Martin, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT04908579: Efficacy of Preventive Ketamine on Postoperative Pain
Official title: Efficacy of Preventive Ketamine on Postoperative Pain: A Randomized, Double-blind Trial of Patients Undergoing Laparoscopic Sleeve Gastrectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Postoperative Pain
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-06-01
Enrollment: 90
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: * Although bariatric surgery is mainly performed laparoscopically, analgesic optimization is still essential to reduce complications and to improve the patients' comfort. In laparoscopic sleeve gastrectomy, the intraoperative peritoneal instillation of bupivacaine hydrochloride (30 ml, 0.25%) was known to be safe and effective in reducing postoperative pain, nausea, and vomiting.
* Furthermore, usage of ketamine both as a pre and post-operative pain management is well established. Ketamine can be used solely or in combination with other co-adjuvant drugs, increasing their efficacy. Many therapeutic properties of ketamine have been attributed to its antagonism mechanism to N-Methyl-D-aspartate receptors.


Eligibility criteria: Inclusion Criteria:

* - Body mass index \> 35 and \< 60 kg/m2
* Either medically free or with well controlled hypertension and/or diabetes.

Exclusion Criteria:

* - Patient's refusal to participate in the study
* BMI \> 60 kg/m2.
* Age less than 21 years.
* Patients with severe systemic disease which is not life-threatening.
* Patients on antipsychotics, antidepressants and/or corticosteroids.
* Patients with history of obstructive sleep apnea.
* Allergic reaction to any of the study medications.

Primary outcomes:
measure: Time to first given rescue analgesia(minutes)
timeFrame: 24 hours postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain-Shams University Hospitals
Study officials:
References:
Clinical trial NCT05795179: Stress & Self-Control Costs
Official title: Neural and Affective Mechanisms Underlying Prospective Self-control Costs
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Self-Control
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2023-04-03
Enrollment: 300
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: Self-control failures are a universal challenge for healthy and clinical populations. Recent work suggests these failures may arise from excessive cognitive costs associated with exercising self-control, yet the mechanisms underlying these costs are unknown. To address this, the investigators will use a validated decision-making task that measures how much individuals will pay (from a study endowment) to restrict access to tempting rewards that may lead to self-control failures. The investigators will examine these costs to identify their cognitive, neural and affective mechanisms. First, the investigators will identify the cognitive and computational mechanism that gives rise to self-control costs. Second, the investigators will characterize the neural correlates of self-control costs and identify neural mediators and connectivity patterns stemming from these costs. Finally, the investigators will examine how different classes of stressors (physical, social, or lifetime stress) shape the behavioral and neural representations of self-control costs.


Eligibility criteria: Inclusion Criteria:

* 18-70 years of age, able to speak, read, and write fluently in English
* be willing and able to follow study procedures and provide informed consent.
* Must additionally confirm they are on a diet to maintain/lose weight and are implementing/maintaining dietary changes.

Exclusion Criteria:

* History of or medication for neurologic or psychiatric disease
* High-blood pressure or heart condition
* Diabetes, food allergies, metabolic disorders or history of eating disorder
* Use of corticosteroids or beta-blockers
* Metallic implants or devices contraindicating magnetic resonance imaging.
* Pregnancy is considered an exclusion criteria due to all stress and scanning procedures, thus pregnant participants will not be permitted to participate in the study.

Primary outcomes:
measure: Average Self-Control Cost
timeFrame: Day 1
measure: Change in fMRI BOLD Signal During Self-Control Decisions
timeFrame: Day 1 (Up to 1.5 Hours)
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Candace Raio
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00735579: Wound Healing Abnormalities in Major Abdominal Surgery
Official title: Incidence of Wound-healing-abnormalities in Major Abdominal Surgery - Association With Factors of Coagulation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Impaired Wound Healing
Factor XIII Deficiency
Keywords: major abdominal surgery
coagulation
extracellular matrix proteins
wound healing after major abdominal surgery
Lead sponsor: Klinikum St. Georg gGmbH
Sponsor class: OTHER
First posted: 2008-08-15
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients undergoing major abdominal surgery

Brief summary: This clinical observational study investigates the incidence of wound healing abnormalities in patients undergoing major abdominal surgery. Second aim of the study is, if wound healing deficits may be accompanied by abnormalities in blood coagulation parameters.


Eligibility criteria: Inclusion Criteria:

* Age \>= 18 years
* Male or female
* Informed consent
* Major abdominal surgery

Exclusion Criteria:

* Pre-existing coagulation abnormalities
* Pre-existing severe renal or liver failure
* Chemo- or radiochemotherapy

Primary outcomes:
measure: Incidence of wound healing abnormalities
timeFrame: from baseline to postoperative day 28
Secondary outcomes:
measure: Abnormalities in coagulation parameters
timeFrame: postoperative day 28
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: Klinikum St. Georg gGmbH
state: Sachsen
Study officials:
affiliation: Klinikum St. Georg gGmbH
name: Armin R Sablotzki, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04310384: 'Single Hand Used inTubaTing Laryngoscope Evaluation' Study
Official title: A Randomized Cross-Over Trial to Determine Whether the 'ShuttleScope® Laryngoscope is Inferior, Equal or Superior Compaired to Macintosh Laryngoscope to Perform Successful Endotracheal Intubation in a Manikin Model.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Respiratory Failure
Cardiac Arrest
Difficult Intubation
Anesthesia Intubation Complication
Keywords: Airway management
Videolaryngoscope
Mannequin
Endotracheal Intubation
Lead sponsor: University of the Basque Country (UPV/EHU)
Sponsor class: OTHER
First posted: 2020-03-17
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DEVICE_FEASIBILITY

Brief summary: This is a study to compare the new ShuttleScope with the standard Macintosh Laryngoscope

Detailed description: Following a 5 minutes workshop with an instructor structured demonstration and practice with both devices, the participants attempt intubation in a normal airway scenario with the Macintosh Laryngoscope and the novel ShuttleScope®, in a manikin model.

Eligibility criteria: Inclusion Criteria:

* Medecine students from the Basque Country University (UPV/EHU)

Exclusion Criteria:

* Other operators different from the ones described above
* Previous experience with ShuttleScope videolaryngoscope
* informed consent non available

Primary outcomes:
measure: Success Rate
timeFrame: During intubation time, intubation attempts allows maximum 3 times, within 90 sec in each time
measure: Time to Endotracheal Intubation
timeFrame: During intubation time, intubation attempts allows maximum 3 times, within 90 sec in each time
Secondary outcomes:
measure: Incidence of' oesophageal intubation
timeFrame: During intubation time, intubation attempts allows maximum 3 times, within 90 sec in each time
measure: Ease of insertion
timeFrame: During intubation time, intubation attempts allows maximum 3 times, within 90 sec in each time ]
Other outcomes:
Locations:
city: Vitoria
country: Spain
facility: Hospital Virtual, Unidad Docente de Medicina, Facultad de Medicina y Enfermeria de la Universidad del País Vasco (UPV/EHU)
state: Alava
Study officials:
affiliation: Airwaymedicalinnovations
name: Julio Miguel Alonso Babarro
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01592084: Hyperlipidemia and Statin Therapy in Amyotrophic Lateral Sclerosis
Official title: Cohort Study of the Relationship of Hyperlipidemia and Statin Therapy on Survival and Disease Progresssion in Amyotrophic Lateral Sclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Amyotrophic Lateral Sclerosis
Keywords: lipid lowering therapy
survival
ALSFRS
age
BMI
weight
Lead sponsor: The Methodist Hospital Research Institute
Sponsor class: OTHER
First posted: 2012-05-07
Enrollment: 267
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: the Methodist Neurological Institute

Brief summary: The role of hyperlipidemia and lipid lowering therapy (LLT) in Amyotrophic Lateral Sclerosis (ALS) pathophysiology and its impact on disease progression and survival is unclear. The investigators analyzed the correlation between lipid levels with disease progression and survival in ALS patients and the association of LLT with these outcomes.


Eligibility criteria: Inclusion Criteria:

* A clinical diagnosis of laboratory-supported probable, probable, or definite familial, sporadic ALS, according to a modified El Escorial criteria (ref), by the study investigators
* Time from disease onset is less than three years

  * 18 years of age
* Subjects with diagnosis of hyperlipidemia and/or taking lipid lowering medications will not be excluded from study.

Exclusion Criteria:

* Requirement for tracheotomy ventilation or non-invasive ventilation for \> 23 hours per day
* Diagnosis of other neurodegenerative diseases (Parkinson disease, Alzheimer disease, etc)
* A clinically significant history of significant medical illness (advanced cancer, chronic inflammatory/infectious conditions, etc) within six months of baseline
* Use of progestins, anabolic steroids, and corticosteroids within 45 days of baseline visit. Therapy is allowed as medically indicated after baseline visit.

Primary outcomes:
measure: survial(tracheostomy free,<23 hours on NIPPV, from enrollment)
timeFrame: 3years
Secondary outcomes:
measure: ALSFRS(measure of disability)
timeFrame: at first evaluation(time 0-T0) to six months (T6)
Other outcomes:
Locations:
city: Houston
country: United States
facility: the Methodist Neurological Institute
state: Texas
Study officials:
affiliation: the Methodist Neurological Institute
name: Ericka P Simpson, M.D
role: STUDY_DIRECTOR
References:
Clinical trial NCT03942484: Efficacy of rPMS for Improvement of Urinary Incontinence and Female Sexual Function
Official title: Efficacy of Repetitive Pulse Magnetic Stimulation for Improvement of Urinary Incontinence and Female Sexual Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Lead sponsor: BTL Industries Ltd.
Sponsor class: INDUSTRY
First posted: 2019-05-08
Enrollment: 45
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Evaluation of the repetitive pulse magnetic stimulation (rPMS) for the treatment of urinary incontinence and a female sexual satisfaction.


Eligibility criteria: Inclusion Criteria:

* Age between 21 and 65 years
* Voluntarily signed informed consent form
* Suffers from UI
* Sexually active
* FSFI Questionnaire score ≤ 26.55 points

Exclusion Criteria:

* Suffers from other types of urinary incontinence other than SUI, UUI, MUI
* Currently lactating
* Cardiac pacemakers
* Implanted defibrillators and/or neurostimulators
* Electronic implants
* Metal implants, including copper IUD
* Drug pumps
* Hemorrhagic conditions
* Anticoagulation therapy
* Fever
* Pregnancy
* Following recent surgical procedures when muscle contraction may disrupt the healing process
* Application over areas of the skin which lack normal sensation

Primary outcomes:
measure: Evaluation of quality of life improvement using the ICIQ-UI questionnaire
timeFrame: 18 months
measure: Evaluation of quality of life improvement using the FSFI questionnaire
timeFrame: 18 months
measure: Evaluation of quality of life improvement using the PISQ-12 questionnaire
timeFrame: 18 months
Secondary outcomes:
measure: Safety evaluation: Incidence of adverse events (AE) associated with study device will be followed.
timeFrame: 18 months
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Julene Samuels
state: Kentucky
city: Farmington Hills
country: United States
facility: Joseph Berenholz
state: Michigan
city: Hillsborough
country: United States
facility: Gynecological Solutions
state: New Jersey
city: West Columbia
country: United States
facility: Southern Urogynecology
state: South Carolina
city: Sugar Land
country: United States
facility: Hillcroft Medical Clinic
state: Texas
Study officials:
References: