louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06642480: Distribution of CYP2D6 Multiplication, CYP2D6*5, and Clinical Implications in Postoperative Patients Receiving Tramadol Analgesia in the Minangkabau Ethnic Group, Indonesia
Official title: Determination of Patients&#39; Visual Analogue Scale (VAS) in Postoperative Patients Receiving Tramadol Analgesia in the Minangkabau Ethnic Group, Indonesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Operative Analgesia
Tramadol
Keywords: Tramadol
Post Operative
Minangkabau
Lead sponsor: Kementerian Riset dan Teknologi / Badan Riset dan Inovasi Nasional, Indonesia
Sponsor class: OTHER_GOV
Collaborators: name: Andalas University
First posted: 2024-10-15
Enrollment: 63
Sex: ALL
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: VAS of 63 patients was determined by injecting tramadol at a dose of 100 mg 30 minutes before the operation was completed. It was observed in the recovery room at 30, 60, and 120 minutes. Tramadol had an onset time of 15-60 minutes, with peak effectiveness at 2-6 hours postoperatively. Pain level was categorized into 0 (no pain), 1-3 (signifying mild), 4-6 (middle), and 7-10 ( heavy pain).
Primary purpose: SCREENING

Brief summary: Cytochrome P450 2D6 (CYP2D6) is an important enzyme in metabolizing commonly used drugs such as Tramadol hydrochloride (widely used opioid analgesic). Genetic polymorphisms of the CYP2D6 gene have been shown to influence the pharmacodynamic properties of the administered drug. This study aimed to screen 63 postoperative patients (wild-type, CYP2D6\*5, and CYP2D6 multiplication) of Minangkabau ethnicity in West Sumatera, Indonesia, who received tramadol using a modified long PCR method and to investigate the clinical impact of tramadol on the patients.

Detailed description: VAS of 63 patients was determined by injecting tramadol at a dose of 100 mg 30 minutes before the operation was completed. It was observed in the recovery room at 30, 60, and 120 minutes. Tramadol had an onset time of 15-60 minutes, with peak effectiveness at 2-6 hours postoperatively. Pain level was categorized into 0 (no pain), 1-3 (signifying mild), 4-6 (middle), and 7-10 ( heavy pain).

Eligibility criteria: Inclusion Criteria:

* Post operative patients who get analgesic tramadol

Exclusion Criteria:

* No exclusion criteria

Primary outcomes:
measure: Determination of Patients&#39; Visual Analogue Scale (VAS)
timeFrame: . It was observed in the recovery room at 30, 60, and 120 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Padang
country: Indonesia
facility: Rsup Dr M Djamil Padang
state: Sumatera Barat
Study officials:
References:
Clinical trial NCT01706380: 3M Study - Maria Malmö Mobile Telephone Study
Official title: A Randomized Controlled Trial of Interactive Voice Response With and Without Personal Feedback in the Treatment of Adolescents With Substance Use Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Use Disorders
Keywords: Substance use disorders
Adolescents
Retention
Mobile telephone
Follow-up
Interactive voice response
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2012-10-15
Enrollment: 73
Sex: ALL
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The present study, in an out-patient setting for substance use treatment in adolescents, examines the effect on treatment retention of a mobile telephone follow-up technique (interactive voice response), with or without personal feedback. Subjects in treatment for substance use disorders will be followed by automated mobile telephone contact with questions about psychiatric symptoms and substance use, and the investigators hypothesize that this technique, including a personal feedback reporting back to the client whether his or her status is changing in one way or another, may increase the treatment retention, possibly by means of an intensified treatment contact.


Eligibility criteria: Inclusion Criteria:

* Patient applying for substance use disorder treatment at out-patient facility Maria Malmö, Malmö, Sweden, who are less than 25 years old and who provide written informed consent to participate in the study.

Exclusion Criteria:

* Patients who do not provide written informed consent to the study, or whose psychiatric condition or language difficulties make it impossible for them to understand patient information and give informed consent to the study.

Primary outcomes:
measure: Retention in substance use disorder treatment
timeFrame: 3 months
Secondary outcomes:
measure: Improvement in substance use
timeFrame: 3 months
measure: Improvements in psychiatric symptoms
timeFrame: 3 months
Other outcomes:
measure: Clinical course with respect to emergency visits
timeFrame: 12 months
measure: Clinical course with respect to hospitalizations
timeFrame: 12 months
measure: Clinical course with respect to repeated treatment episodes
timeFrame: 12 months
Locations:
city: Malmö
country: Sweden
facility: Maria Malmö, Dept of Psychiatry Skane and City of Malmö, Sweden
state: Skane
Study officials:
References:
Clinical trial NCT04549480: Bioequivalence Study of Bosutinib Pediatric Capsule Relative to Commercial Tablet Under Fed Condition
Official title: A PHASE 1, OPEN-LABEL, RANDOMIZED, 2-PERIOD, 2-SEQUENCE, CROSSOVER STUDY TO EVALUATE THE BIOEQUIVALENCE OF BOSUTINIB PEDIATRIC CAPSULE AND THE COMMERCIAL TABLET FORMULATIONS IN HEALTHY PARTICIPANTS UNDER FED CONDITION
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Keywords: bosutinib,
bioequivalence,
Cmax,
AUC
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2020-09-16
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study is intended to establish bioequivalence of the bosutinib age-appropriate capsule formulation to the commercial tablet formulation in healthy participants under fed condition. The comparison will be performed using the pharmacokinetic parameters that define the rate and extent of absorption, those are Cmax and AUC. A statistical analysis will be performed comparing these parameters calculated after administration of a single 100 mg dose with the tablet formulation (100 mg x 1) as the Reference treatment and the capsule formulation (100 mg x 1) as the Test treatment.


Eligibility criteria: Inclusion Criteria:

1. Female participants of non childbearing potential and/or male participants must be 18 to 54 years of age, inclusive, at the time of signing the ICD.
2. Capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.

Exclusion Criteria:

1. Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, dermatological, or allergic disease.
2. Any condition possibly affecting drug absorption.

Primary outcomes:
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-inf)]
timeFrame: 6 days
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: 6 days
Secondary outcomes:
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
timeFrame: 6 days
measure: Time to Cmax (Tmax)
timeFrame: 6 days
measure: Apparent Oral Clearance (CL/F)
timeFrame: 6 days
measure: Apparent Volume of Distribution (Vz/F)
timeFrame: 6 days
measure: Plasma elimination half-life (t1/2)
timeFrame: 6 days
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: PRA Health Sciences
city: Utrecht
country: Netherlands
facility: PRA Health Sciences Utrecht
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT05462080: Correlation of Motor Metrics and Neurological Data
Official title: Correlation of Motor Metrics and Neurological Data (COMMAND)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Movement Disorders (Incl Parkinsonism)
Lead sponsor: Ceraxis Health, Inc
Sponsor class: INDUSTRY
First posted: 2022-07-18
Enrollment: 29
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Movement disorders patients being treated at the site

Brief summary: This is a pilot study to collect data with the Ceraxis product and standard movement disorders tests in order to prove and codify potential correlations.


Eligibility criteria: Inclusion Criteria:

* Adult with a diagnosis of idiopathic Parkinson's disease or essential tremor by a movement disorders neurologist
* Age greater than or equal to 21 years
* Hoehn and Yahr stage I-III
* Ability to ambulate 200+ meters independently
* Ability to follow 2-step commands
* Clinically responsive to medication or Deep Brain Stimulation (DBS)
* Clinically optimized medication or DBS for at least six months
* Able to tolerate withdrawal of medication and/or DBS

Exclusion Criteria:

* Any comorbidity which would exclude them from being able to use the Ceraxis product
* Inability to learn how to use the system
* Diagnosis of dementia or impairment that compromises the ability to provide informed consent
* Neurological disease other than Parkinson's disease or essential tremor (i.e. multiple sclerosis, stroke with residual motor deficits)
* Musculoskeletal injury that significantly alters gait

Primary outcomes:
measure: Collection of data with Ceraxis product (stylus product with a built-in Inertial Measurement Unit (IMU) which includes a 3-axis accelerometer, gyroscope, and magnetometer, as well as a force sensing tip)
timeFrame: Day 1
Secondary outcomes:
measure: UPDRS-I, UPDRS-II, and UPDRS-III assessment for patients with Parkinson's disease
timeFrame: Day 1
measure: TETRAS tremor rating scale for patients with Essential Tremor
timeFrame: Day 1
measure: Upper extremities motor strength, assessed by neurological examination
timeFrame: Day 1
measure: Coordination test for the upper extremities to evaluate dysdiadochokinesia
timeFrame: Day 1
measure: Archimedes Spiral task
timeFrame: Day 1
measure: Freezing of Gait questionnaire
timeFrame: Day 1
measure: Usage Survey
timeFrame: Day 1
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
Study officials:
References:
Clinical trial NCT00805480: Multiple-loading Dose Regimen Study in Patients With Chronic Plaque-type Psoriasis
Official title: Phase II Randomized, Double-blind, Multi-center, Parallel-group, Placebo-controlled Multiple-loading Dose Regimen Study to Assess the Safety, Efficacy and Duration of Response of AIN457 in Patients With Chronic Plaque-type Psoriasis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Plaque Psoriasis
Keywords: Plaque
psoriasis
inflammatory skin disease
skin condition, thickening
flaking
scaly patches
skin disease
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-12-09
Enrollment: 130
Sex: ALL
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: Loading dose, four arm, double-blind, parallel group, placebo-controlled study comparing single and multiple doses of AIN457 to placebo in patients with a diagnosis of moderate to severe chronic plaque psoriasis.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of plaque psoriasis for at least 6 months prior to screening. The patients must meet all of the following criterion:

  1. Coverage of the body surface area (BSA) of 10% or more with plaques
  2. A score of 3 or more on the IGA scale
  3. A PASI score of at least 12 at baseline

     Exclusion Criteria:
* Have forms of psoriasis other than the required "plaque psoriasis"
* Women of childbearing potential
* Recent use of investigational drugs or treatment with other biological therapies (wash-out periods required)
* Previous treatment with this investigational drug
* Subjects with active or history of clinically significant cardiac, kidney or liver abnormalities;

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Change From Baseline in Psoriasis Area and Severity Index (PASI) Scores
timeFrame: Baseline, Week 12
measure: Percentage of Participants Who Had Not Relapsed at Any Time in the Trial
timeFrame: Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52 and 56
Secondary outcomes:
measure: Percentage of Participants With at Least 50% Improvement From Baseline in PASI
timeFrame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, end of study (EOS) (up to week 56)
measure: Percentage of Participants With at Least 75% or 90% Improvement From Baseline in PASI
timeFrame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, EOS (up to week 56)
measure: Percentage of Participants in Each Investigator Global Assessment (IGA) Category
timeFrame: Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, EOS (up to week 56)
Other outcomes:
Locations:
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
affiliation: Novartis Investigator Site
name: Novartis
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02537080: The Effect of Nimodipine on the Postoperative Cognitive Dysfunction
Official title: The Effect of Nimodipine in the Preoperative Period on the Onset of Postoperative Cognitive Dysfunction in Adults
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: Postoperative cognitive dysfunction
Nimodipin
Anesthesia
Lead sponsor: University Hospital Hradec Kralove
Sponsor class: OTHER
First posted: 2015-09-01
Enrollment: 15
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The calcium channel blocker nimodipine dilates cerebral blood vessels and can pass through the blood-brain barrier, providing neuroprotective effects by selectively improving cerebral blood flow and inhibiting neuronal necrosis and apoptosis. Nimodipine significantly inhibited the production of tumor necrosis factor TNF-α and interleukin IL-1β, and also of nitric oxide and prostaglandin E2 from lipopolysaccharide-stimulated microglia. Abnormal cytokine networks are important in the development of nerve cell damage that leads to cognitive impairment.

Detailed description: All patients aged above 60 years undergoing planned neurosurgical operations in the duration up to 4 hours under general anesthesia will be included in the study. The patients will not be sedated by any type of benzodiazepine. A dose of 30 mg nimodipine or placebo will be applied 45 minutes before the surgery according to the randomization. Anesthesia will be managed according to the standardised protocol. Concentration of desflurane will be adjusted according to entropy values (target 40-50). Analgetics will be applied according to surgical pleth index (SPI) values. Sufentanil will not be applied in the last 15 minutes. Extubation will be performed at the operating theatre when meeting all extubation criteria including train of four ratio (TOFR) above 92%. Neither syntophylline, nor pharmacological decurarization (syntostigmine) will be applied to the patients.During the surgery, blood pressure will be maintained within ± 15% of the patient's normal blood pressure. Cognitive dysfunction tests will be executed on the day before the surgery, two hours after the surgery and on the third postoperative day.

Eligibility criteria: Inclusion Criteria:

* Glascow coma scale GCS 15 preoperatively
* American Society of Anesthesiologists ASA risk I - III
* planned brain surgery
* duration of procedure up to 4 hours.

Exclusion Criteria:

* blood pressure below 130/80 torr preoperatively
* previous vascular surgery
* concomitant use of antiepileptic drugs, rifampicin
* allergy to nimodipine
* known liver cirrhosis

Primary outcomes:
measure: Change in cognitive behavior
timeFrame: within the first 3 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Hradec Kralove
country: Czechia
facility: University Hospital
Study officials:
affiliation: University Hospital Hradec Kralove
name: Vlasta Dostalova, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00158080: Hemofiltration for Contrast-Induced Nephropathy
Official title: Prevention of Contrast-Induced Nephropathy by Real-Time Hemofiltration
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Kidney Disease
Cardiac Catheterization
Lead sponsor: Nara Medical University
Sponsor class: OTHER
First posted: 2005-09-12
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Contrast-induced acute renal failure can be prevented with hemofiltration which is performed during cardiac catheterization


Eligibility criteria: Inclusion Criteria:

* Patients with serum creatinine\>2.0mg/dl and/or GFR\<50ml/min

Exclusion Criteria:

* Emergent cardiac catheterization
* Patients on chronic dialysis
* Patients with HYHA\>III heart failure

Primary outcomes:
measure: Prevention of contrast-induced acute renal failure, Elevation of serum creatinine
Secondary outcomes:
measure: Need for hemodialysis
Other outcomes:
Locations:
city: Kashihara
country: Japan
facility: First Dept of InternalMedicine, Nara Medical University
state: Nara
Study officials:
affiliation: Nara Medical University
name: Yoshihiko Saito, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Kashyap AS, Anand KP, Kashyap S. Hemofiltration and the prevention of radiocontrast-agent-induced nephropathy. N Engl J Med. 2004 Feb 19;350(8):836-8; author reply 836-8. No abstract available.
Clinical trial NCT01203280: Icing Effects on Neck Functions of the Boxers
Official title: Icing Effects on Neck Functions of the Boxers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Balance
Keywords: icing
boxer
balance
neck range of motion
neck isometric strength
balance performance
Lead sponsor: Taipei Physical Education College
Sponsor class: OTHER
First posted: 2010-09-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Most boxing injuries occurs over head and neck which leads to potentially acute or chronic head and neck injuries. Patients with whiplash injury has been reported, reflected by increased body sway and reduced ability to overcome challenging balance tasks. The purpose of this research is to evaluate the fitness and balance outcomes between the boxers and the control group, and boxers undergoing posterior-neck icing effects.

Detailed description: Injuries are common in boxing, occurring most often to the head, neck, face, and hands. Traumatic minor cervical strains are common place in high-impact sports and premature degenerative changes have been documented in sports people exposed to recurrent impact trauma or repetitive forces. Whiplash injury may result in extensive trauma to muscles and ligamentous structures within the cervical spine . Many of these structures, particularly the muscles, contain mechanoreceptors that play a key role in position sense. Studies have shown that head and neck position sense may become impaired following whiplash injury. Subsequently, poor movement patterns, together with the perpetuation of pain and other symptoms may develop.

Posture control is achieved by integration of sensory inputs emanating from somatosensory, vestibular, and visual systems. Patients with whiplash injury has been reported, reflected by increased body sway and reduced ability to overcome challenging balance tasks. In this study we have attempted to evaluate the influence of boxing on balance performances, isometric strength and flexibility; furthermore, evaluate the therapeutic effect of ice massage on boxers.

Eligibility criteria: Inclusion Criteria:

* boxers
* Must be able to cooperate to our intervention

Exclusion Criteria:

* Any head and neck injury in recent six months
* personal history of head and neck surgery, tumor, infection, and musculoskeletal disease of neck
* Lesions of central or peripheral nervous system, such as visual or vestibular system, any of which may also affect performance of balance

Primary outcomes:
measure: balance performance on the sensory organization test (SOT)
Secondary outcomes:
measure: neck isometric strength in six directions
measure: neck range of motion in six directions
Other outcomes:
Locations:
city: Taoyuan County
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
References: