louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04637087: Precision Medicine in Ischemic Stroke and Atrial Fibrillation
Official title: Precision Medicine in Ischemic Stroke and Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Ischemic Stroke
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Boston University
First posted: 2020-11-19
Enrollment: 805
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The overall goal of this study is to minimize morbidity due to Atrial Fibrillation (AF). The specific objective is to develop and implement a rational and personalized approach to AF risk estimation that can inform management decisions with ischemic stroke. The investigators propose to develop a clinical AF risk estimation tool in the electronic health record and to test the effectiveness of implementing a clinical AF risk estimation tool into care for use by stroke neurologists during the care of acute ischemic stroke patients at Massachusetts General Hospital. The investigators will evaluate cardiac monitoring utilization calibrated to AF risk by stroke neurologists using a custom electronic health record (EHR) notification module.

The investigators hypothesize that cardiac rhythm monitoring utilization will be positively correlated with the predicted risk of AF.


Eligibility criteria: Inclusion Criteria:

* Patients aged 18 years or older
* Presenting with a primary diagnosis of ischemic stroke or transient ischemic attack admitted to Massachusetts General Hospital inpatient stroke service

Exclusion Criteria:

* Patients not meeting above inclusion criteria

Primary outcomes:
measure: Incidence of cardiac rhythm monitoring
timeFrame: 6-months
Secondary outcomes:
measure: Proportion of patients with implantable loop recorder orders
timeFrame: 12-months
measure: Proportion of patients with ambulatory wearable cardiac rhythm monitoring orders
timeFrame: 12-months
measure: Proportion of patients with cardiac monitor ordered by neurologist
timeFrame: 1-month
measure: Proportion of patients with a new atrial fibrillation diagnosis
timeFrame: 12-months
measure: Proportion of patients with recurrent stroke
timeFrame: 12-months
measure: Proportion of patients deceased
timeFrame: 12-months
measure: Proportion of patients with transesophageal echocardiogram utilization
timeFrame: 3-months
measure: Proportion of patients with oral anticoagulation prescription
timeFrame: 12-months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Christopher D Anderson, MD, MMSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01864187: Pharmacokinetics of Dexmedetomidine in Morbid Obesity
Official title: A Study of the Pharmacokinetics of Dexmedetomidine in Morbid Obesity.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Obesity
Keywords: Pharmacokinetics
Dexmedetomidine
Obesity
Lead sponsor: Guangzhou General Hospital of Guangzhou Military Command
Sponsor class: OTHER
First posted: 2013-05-29
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Dexmedetomidine hydrochloride ,a relatively new drug in Chinais ,is a highly selective, potent a2-adrenoceptor agonist with significant analgesic, sedative and anxiolytic effects. The morbid obesity in Chinese population is rapidly increasing. But the pharmacokinetics of the drug in these people is still unknown.This research was designed to study the pharmacokinetics of dexmedetomidine in Chinese morbidly obese population.

Detailed description: For the obese are sensitive to the disease such as hypertension, ischaemic heart disease and diabetes, the changes of the state may affect the pharmacokinetics of dexmedetomidine. Besides,the clearance of dexmedetomidine is parallel with liver function and it is excreted by kidney, so differences in the obese may be expected.

About 10 obese patients and 10 matched healthy volunteers with normal weight would be chosen to receive a normal dosage of dexmedetomidine. And venous samples will be collected in different time points. Next the investigators can get the plasma concentration of dexmedetomidine by the use of HPLC-MS. And then the plasma concentration could be analyzed.

Eligibility criteria: Inclusion Criteria:

1. Weight:28≦BMI≦45 and 18.5≦BMI≦24
2. Written informed consent from the patient or the relatives of the participating patient.

Exclusion Criteria:

1. A previous history of intolerance to the study drug or related compounds and additives.
2. Existing significant haematological, endocrine, metabolic or gastrointestinal disease.

Primary outcomes:
measure: Plasma Concentration of dexmedetomidine
timeFrame: 0, 5, 10, 15, 20, 25, 30, 45 , 60, 90, 120, 150,180,240,360,480 hours post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou Military Region General Hospital, Department of Anesthesiology
state: Guangdong
Study officials:
References:
citation: Iirola T, Aantaa R, Laitio R, Kentala E, Lahtinen M, Wighton A, Garratt C, Ahtola-Satila T, Olkkola KT. Pharmacokinetics of prolonged infusion of high-dose dexmedetomidine in critically ill patients. Crit Care. 2011;15(5):R257. doi: 10.1186/cc10518. Epub 2011 Oct 26.
citation: Xu B, Zhou D, Ren L, Shulman S, Zhang X, Xiong M. Pharmacokinetic and pharmacodynamics of intravenous dexmedetomidine in morbidly obese patients undergoing laparoscopic surgery. J Anesth. 2017 Dec;31(6):813-820. doi: 10.1007/s00540-017-2399-y. Epub 2017 Aug 21.
Clinical trial NCT01496287: Tympanostomy Tube Placement in Children in the Office (Inova Study)
Official title: Tympanostomy Tube Placement in Children in the Office (Inova Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Otitis Media
Lead sponsor: Integra LifeSciences Corporation
Sponsor class: INDUSTRY
Collaborators: name: Acclarent
First posted: 2011-12-21
Enrollment: 70
Sex: ALL
Minimum age (years): 6
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of the study is to evaluate the safety and efficacy of the Acclarent Tula TDS for the placement of tympanostomy tubes under local anesthesia in an office/clinic setting.


Eligibility criteria: Inclusion Criteria:

1. Scheduled to undergo tympanostomy tube insertion
2. At least 6 months old and younger than 22 years old
3. Behavioral capacity and cooperative temperament to undergo an awake procedure (based on physician judgement)
4. No history of sensitivity or reaction to anesthesia chosen for the procedure

Exclusion Criteria:

1. Pregnant or lactating females
2. Significantly atrophic, bimeric, or completely atelectatic tympanic membrane
3. Otitis externa
4. Lacerations or abrasions to the external auditory canal or damaged or denuded skin in the auditory canal
5. Cerumen impaction resulting in a significant amount of cleaning required to visualize the tympanic membrane
6. Electrically sensitive subjects and subjects with electrically sensitive support systems (pacemakers, defibrillators, etc.)
7. Anatomy that precludes sufficient visualization of and access to the tympanic membrane
8. Anatomy that necessitates tympanostomy tube placement in the posterior half of the tympanic membrane

Primary outcomes:
measure: Number of Participants With Procedural, Serious, and Device-Related Adverse Events
timeFrame: procedure up to 2 weeks post procedure
measure: Device Success
timeFrame: Day 0 (day of procedure)
Secondary outcomes:
measure: Procedure Success
timeFrame: Day 0 (day of procedure)
measure: Procedure Tolerability
timeFrame: Day 0 (day of procedure)
measure: Tube Retention
timeFrame: 2 weeks post procedure
Other outcomes:
Locations:
city: Port Saint Lucie
country: United States
facility: South Coast Ear, Nose & Throat
state: Florida
Study officials:
affiliation: South Coast Ear, Nose & Throat
name: Jacob W Zeiders, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zeiders JW, Syms CA, Mitskavich MT, Yen DM, Harfe DT, Shields RD, Lanier BJ, Gould AR, Mouzakes J, Elliott CL. Tympanostomy tube placement in awake, unrestrained pediatric patients: A prospective, multicenter study. Int J Pediatr Otorhinolaryngol. 2015 Dec;79(12):2416-23. doi: 10.1016/j.ijporl.2015.11.003. Epub 2015 Nov 10.
citation: Cohen LL, Martin SR, Gamwell KL, McCarty C, Shih SW. Behavioral techniques to optimize success of in-office pediatric tympanostomy tube placement without sedation. Int J Pediatr Otorhinolaryngol. 2015 Dec;79(12):2170-3. doi: 10.1016/j.ijporl.2015.09.041. Epub 2015 Oct 8.
Clinical trial NCT03981887: Safety, Tolerability, and Pharmacokinetics of Multiple Doses of Intravenous Nafithromycin
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Multiple Doses of Intravenous Nafithromycin in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Wockhardt
Sponsor class: INDUSTRY
Collaborators: name: Clinartis, LLC
name: Keystone Bioanalytical, Inc.
First posted: 2019-06-11
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This will be a Phase 1, randomized, double-blind, single-center, placebo-controlled study in healthy male and female adult subjects. Subjects will be randomly assigned to receive either nafithromycin or placebo by intravenous (IV) infusion based on a double-blind randomization schedule. The following treatments will be administered:

* Nafithromycin 200 mg or placebo administered as IV infusions twice daily (q12h) over a period of 3 hours for 3 days.
* Eight subjects (n=8) will receive nafithromycin and 2 subjects (n=2) will receive placebo.


Eligibility criteria: Inclusion Criteria:

* Body mass index (BMI) ≥18 to ≤32 kg/m2, both inclusive.
* Stable health based on a medical history without any major pathology/surgery in the 6 months before Screening and no clinically significant physical examination findings or clinical laboratory test results
* Resting supine blood pressure of 90 to 139 mmHg (systolic) and 60 to 89 mmHg (diastolic) and a resting heart rate of 50 to 100 beats per minute at Screening and Check-in (Day -1).
* Calculated creatinine clearance ≥80 mL/min (Cockroft-Gault method) at Screening.
* Computerized 12-lead electrocardiogram (ECG) recording without signs of clinically significant pathology and showing no clinically significant deviation as judged by the investigator

Exclusion Criteria:

* Participation in another investigational drug or device study or treated with an investigational product within 30 days or 5 half-lives, whichever is longer, before study drug administration in this study.
* History/evidence of clinically relevant pathology
* History of clinically significant food or drug allergy
* Positive alcohol or urine drug screen

Primary outcomes:
measure: To assess safety
timeFrame: Day 19
measure: To assess multiple dose drug tolerability
timeFrame: Day 19
Secondary outcomes:
measure: To assess plasma PK parameters profile
timeFrame: Day 3
measure: To assess plasma PK parameters profile
timeFrame: Day 3
measure: To assess plasma PK parameters profile
timeFrame: Day 3
measure: To assess plasma PK parameters profile
timeFrame: Day 3
Other outcomes:
Locations:
city: West Bend
country: United States
facility: Spaulding Clinical Research
state: Wisconsin
Study officials:
affiliation: Spaulding Clinical Research LLC
name: Carlos Sanabria, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01987687: Effect of Timing of a Post-exercise Oral Glucose Tolerance Test on Glycaemic Control.
Official title: Effect of Timing of a Post-exercise Oral Glucose Tolerance Test on Glycaemic Control.
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Area Under Curve [N06.850.520.830.200]
Lead sponsor: Northumbria University
Sponsor class: OTHER
First posted: 2013-11-19
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Postprandial glycaemic control is an important risk factor for the development of type 2 diabetes, cardiovascular disease and all-cause mortality.

Previous research has demonstrated that exercise performed in the postprandial state paradoxically results in a deterioration in glucose tolerance in the immediate post-exercise period (Gonzalez et a. 2013; Gonzalez and Stevenson 2013). This study aims to assess the timecourse of this post-exercise effect.


Eligibility criteria: Inclusion Criteria:

* Normal weight (18-25 kg/m2)
* Physically active (\>or= 3 times per week)
* Male

Exclusion Criteria:

* Contraindications to exercise
* Food intolerances
* Food allergies

Primary outcomes:
measure: Postprandial glucose concentration area under the curve
timeFrame: 90 min
Secondary outcomes:
measure: Postprandial insulin concentration area under the curve
timeFrame: 90 min
Other outcomes:
Locations:
city: Newcastle upon Tyne
country: United Kingdom
facility: Northumbria University
state: Tyne and Wear
Study officials:
affiliation: Northumbria University
name: Javier T Gonzalez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gonzalez JT, Stevenson EJ. Assessment of the post-exercise glycemic response to food: considering prior nutritional status. Nutrition. 2014 Jan;30(1):122-3. doi: 10.1016/j.nut.2013.05.015. Epub 2013 Sep 18. No abstract available.
citation: Gonzalez JT, Veasey RC, Rumbold PL, Stevenson EJ. Breakfast and exercise contingently affect postprandial metabolism and energy balance in physically active males. Br J Nutr. 2013 Aug;110(4):721-32. doi: 10.1017/S0007114512005582. Epub 2013 Jan 29.
Clinical trial NCT06271187: Dynamic-orthosis Programs for Stroke Hand Function
Official title: Development of Innovative Modular 3D-Printed Dynamic Orthoses: Application Programs for Hand Function Facilitation in Patients With Stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
Collaborators: name: National Science and Technology Council, Taiwan
First posted: 2024-02-21
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to investigate the training benefits of modular 3D printed dynamic orthoses on upper limb function in stroke survivors.

Detailed description: This study is a randomized controlled intervention trial. Participants are recruited from two medical centers in Taiwan and undergo a continuous 6-week intervention for post-stroke movement rehabilitation. The control group receives traditional stroke occupational therapy rehabilitation. The experimental group, in addition to traditional treatment, supplements their therapy with the use of modular 3D printed dynamic orthoses developed by the research team for home training. Both groups undergo two effectiveness follow-up assessments, one month and two months after the intervention.

Eligibility criteria: Inclusion criteria:

1. Onset of stroke at least three months ago;
2. Upper limb Brunnstrom stage II\~IV;
3. Shoulder can actively flex at least 45 degrees.

Exclusion criteria:

1. Affected hand has regained autonomous grasping function, able to grasp and release a tennis ball 10 times within 2 minutes;
2. Joint deformity or stiffness in the affected hand that prevents the use of the dynamic orthosis;
3. Diagnosis of other neurological disorders affecting motor control, such as neglect, Parkinson's disease, etc.;
4. Inability to follow therapist guidance;
5. Currently undergoing other specific treatments affecting motor function recovery (such as rTMS and BTX).

Primary outcomes:
measure: Fugl-Meyer Assessment- Upper Extremity
timeFrame: Pre-test(Week 0), post-test(Week 6), follow-up assessment（Week 10 & Week 14）
measure: Box and Block Test
timeFrame: Pre-test(Week 0), post-test(Week 6), follow-up assessment（Week 10 & Week 14）
measure: Motor Activity Log
timeFrame: Pre-test(Week 0), post-test(Week 6), follow-up assessment（Week 10 & Week 14）
Secondary outcomes:
measure: Modified Ashworth scale
timeFrame: Pre-test(Week 0), post-test(Week 6), follow-up assessment（Week 10 & Week 14）
measure: Upper limb joint range of motion
timeFrame: Pre-test(Week 0), post-test(Week 6), follow-up assessment（Week 10 & Week 14）
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Cheng Kung University
Study officials:
affiliation: National Cheng Kung University
name: JERHAO CHANG, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02612987: iCBT for Adolescents With Co-morbid Insomnia
Official title: Internet-delivered Cognitive Behaviour Therapy for Adolescents With Co-morbid Insomnia Attending Children and Youth Psychiatry: An Open Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dyssomnias
Keywords: CBT
Internet based
Lead sponsor: Uppsala University Hospital
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
name: Uppsala University
First posted: 2015-11-24
Enrollment: 21
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Insomnia is a commonly reported comorbidity for adolescents with psychiatric conditions. It is well-known that insomnia can exacerbate the concurrent psychiatric symptom load. Treatment of insomnia has been extensively examined in adults, but studies with adolescents are sparse. The purpose of this pilot study is to assess the feasibility and efficacy of internet-based cognitive behavioral therapy for insomnia (iCBT) in outpatients of Children and Youth Psychiatry. Twenty-one adolescents will be recruited and receive 7 weeks of iCBT. Outcome will be measured at pre treatment, at post treatment and at a three months follow-up. Weekly assessments will also be made during treatment on primary outcome and a presumed process variable constructed for the purpose of this trial.


Eligibility criteria: Inclusion Criteria:

* To fulfill the diagnostic criteria for insomnia
* To have access to a computer with Internet connection
* No previous or ongoing CBT for insomnia
* No psychotropic medication or being on a stable dosage for at least six weeks before enrollment

Exclusion Criteria:

* Ongoing manic or psychotic episode
* Being at high risk of triggering manic or psychotic episode
* Ongoing sleep apnea

Primary outcomes:
measure: Insomnia Severity Index (ISI; Morin, 1993)
timeFrame: Pre treatment, weekly during treatment (e.g. from date of treatment start for seven weeks until treatment is terminated), post treatment (e.g. seven weeks after the patient has started treatment), 3 month follow-up
Secondary outcomes:
measure: The Core Consensus Sleep Diary (Core CSD; Carney et al., 2012)
timeFrame: Pre treatment, weekly during treatment (e.g. from date of treatment start for seven weeks until treatment is terminated), post treatment (e.g. seven weeks after the patient has started treatment), 3 month follow-up
measure: Symptoms Checklist (SCL-90; Derogatis et al., 1994)
timeFrame: Pre treatment, post treatment (e.g. seven weeks after the patient has started treatment), 3 month follow-up
measure: Montgomery-Åsberg Depression Rating Scale - Self report (MADRS-S; Svanborg & Åsberg, 1994)
timeFrame: Pre treatment, post treatment (e.g. seven weeks after the patient has started treatment), 3 month follow-up
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
state: Uppsala Län
Study officials:
affiliation: Uppsala University Hospital
name: Vendela Zetterqvist, Ph D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01799187: Research of Revascularization in Immature Teeth With Periapical Periodontitis
Official title: Randomized Controlled Research of Revascularization in Immature Permanent Teeth With Periapical Periodontitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Periapical Periodontitis
Keywords: Immature Permanent Teeth
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: Sun Yat-sen University
First posted: 2013-02-26
Enrollment: 190
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Revascularization is an alternative new treatment of immature permanent teeth with necrotic pulp nowadays while apexification is the traditional therapy. The investigators suppose that revascularization is superior to apexification at developing the root of immature permanent teeth and reducing the risk of root fracture,and the research is designed.

Detailed description: The investigators design to collect a group of patients presenting immature permanent teeth with periapical periodontitis in certain criterion. The investigators will divide the patients into two groups randomly. One group will get treated with revascularization while the other with apexification. The investigators want to evaluate the short-term and long-term effects of the two groups to get a conclusion of the clinical value of revascularization.

Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of periapical periodontitis
* must be immature permanent teeth
* must be local Guangzhou

Exclusion Criteria:

* blood disease
* residual root that is advised to extract
* serious periodontitis
* women in pregnancy

Primary outcomes:
measure: Evidence of lesion healing confirmed by cone beam computed tomography
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guanghua hospital of stomotology,Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Guanghua hospital of stomotology,Sun Yat-sen University
name: ling j qi, PhD
role: STUDY_CHAIR
References:
citation: Jung IY, Lee SJ, Hargreaves KM. Biologically based treatment of immature permanent teeth with pulpal necrosis: a case series. J Endod. 2008 Jul;34(7):876-87. doi: 10.1016/j.joen.2008.03.023. Epub 2008 May 16.