louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01099748: Estimate The Effect Of Lersivirine On The Pharmacokinetics Of S- And R-Methadone
Official title: Open Label, Single-Sequence Study To Estimate The Effect Of Lersivirine (UK-453,061) On S- And R-Methadone In Subjects Receiving Chronic Methadone Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Drug interaction
pharmacokinetics
lersivirine
methadone
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-04-07
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study is to estimate the effect of lersivirine on the pharmacokinetics of R-methadone and S-methadone and to investigate the safety and tolerability of lersivirine when co-administered with methadone. Symptoms of methadone withdrawal will also be assessed.


Eligibility criteria: Inclusion Criteria:

* Healthy male and/or female subjects (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history except drug abuse), full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).
* Body Mass Index (BMI) of 17.5 to 35.5 kg/m2; and a total body weight \>50 kg (110 lbs).
* Receiving stable methadone maintenance treatment for at least 3 months (dose range 50-150 mg QD).

Exclusion Criteria:

* Subjects on therapy for Hepatitis B and/or Hepatitis C; Evidence of impaired liver function (ie, AST and/or ALT greater than 3 times the upper limit of normal, total bilirubin \>1.5 times the upper limit of normal, albumin \<3.5 g/dL).
* 12-lead ECG demonstrating QTc \>450 msec for males and QTc \>470 msec for females or any other clinically significant abnormalities at screening.

Primary outcomes:
measure: R-methadone and S-methadone plasma pharmacokinetic parameters: AUC24, Cmax, Tmax, and C24h on Days 1 and 11
timeFrame: Day 12
Secondary outcomes:
measure: Safety and toleration assessed by spontaneous reporting of adverse events, vital signs, 12-lead ECG and laboratory safety assessments
timeFrame: Day 12
measure: Symptoms of methadone withdrawal as assessed by the Short Opiate Withdrawal Scale (SOWS), Desires for Drug Questionnaire (DDQ) and Pupillary Diameter measurement performed on Days 0 -12.
timeFrame: Day 12
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Pfizer Investigational Site
state: Pennsylvania
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01142648: Sugammadex and Brain Waves
Official title: The Effect of Sugammadex of EEG-derived Index Values
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anaesthesia
Keywords: Electroencephalogram
Electromyogram
Entropy Index
Bispectral Index
Reversal of neuromuscular blockade
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
First posted: 2010-06-11
Enrollment: 30
Sex: FEMALE
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: According to our experience, electroencephalogram-based indices of anaesthetic state show elevated numbers after administration of sugammadex (new reversal of neuromuscular blockade). This can be due to altered anaesthetic state, or some kind of artefact. In this study, the phenomenon is evaluated in detail.

Detailed description: Rocuronium-induced neuromuscular blockade is antagonized with sugammadex or neostigmine. BIS, Entropy and the biosignal collected from the Entropy strip are collected on computer. The behaviour of these parameters before, during and after reversal on neuromuscular blockade will be analyzed in detail.

Eligibility criteria: Inclusion Criteria:

* females giving informed consent
* age range 18-65 years
* elective surgery: gynaecological
* general anaesthesia
* ASA classification 1 or 2

Exclusion Criteria:

* pregnancy
* body mass index \> 30
* disease affecting CNS
* overuse of alcohol
* drug abuse
* unability to understand, read or use Finnish language

Primary outcomes:
measure: The behaviour of depth of anaesthesia indexes (BIS,SE,RE)
timeFrame: 30 minutes
Secondary outcomes:
measure: The behaviour of electroencephalography
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Tampere
country: Finland
facility: Tampere University Hospital
Study officials:
affiliation: Tampere University Hospital
name: Arvi Yli-Hankala, MD
role: STUDY_CHAIR
affiliation: Tampere University Hospital
name: Arvi Yli-Hankala, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01101126: Disease Management in Asthma or Chronic Obstructive Pulmonary Disease (COPD) Patients
Official title: Disease Management Program for Chronic Obstructive Pulmonary Diseases in Maccabi Health Services
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Asthma
Keywords: Chronic obstructive pulmonary disease (COPD)
Asthma
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Maccabi Healthcare Services, Israel
First posted: 2010-04-09
Enrollment: 492
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether disease management program is effective in preventing acute exacerbations in patients with unstable chronic obstructive pulmonary disease (COPD) or asthma.

Detailed description: The aim of the present study is to test the efficacy of a comprehensive community disease management program in patients with unstable chronic obstructive pulmonary disease (COPD) or asthma. The intervention is delivered by designated nurses and pulmonologists, in collaboration with the primary practitioners and other healthcare professionals at the community, in the Jerusalem and the Lowland District of Maccabi Health Services in Israel.

The main purpose is to evaluate the effect of the intervention on the use acute care and emergency health services for acute exacerbation of the lung disease.

Secondary objectives include the evaluation of the effect of the intervention on quality of life, physical function, pulmonary function test, depression and all-cause mortality.

Eligibility criteria: Inclusion Criteria:

1. Men and women
2. 40 years or older
3. Having unstable COPD or Asthma

Exclusion Criteria:

1. Significant LV dysfunction
2. Other severe chronic morbidity compromising short-term survival
3. Significant cognitive impairment or psychiatric disease
4. Bedridden
5. Homeless or no telephone connection

Primary outcomes:
measure: Healthcare services utilization for acute exacerbations of pulmonary disease
timeFrame: Every 6 months during 1-3 years' follow-up
Secondary outcomes:
measure: Quality of life
timeFrame: Every 6 months during 1-3 years' follow-up
measure: Pulmonary function tests
timeFrame: Every 6 months during 1-3 years' follow-up
measure: Physical function
timeFrame: Every 6 months during 1-3 years' follow-up
measure: Depression
timeFrame: Every 6 months during 1-3 years' follow-up
Other outcomes:
Locations:
city: Bat-Yam
country: Israel
facility: Maccabi Pulmonary Clinic
city: Holon
country: Israel
facility: Maccabi Pulmonary Clinic
Study officials:
affiliation: Maccabi Healthcare Services, Israel
name: Meir Raz, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Sheba Medical Center
name: Ofra Kalter - Leibovici, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02921126: Real-World Evidence of Anticoagulation Treatment In Non-Valvular Atrial Fibrillation In Italy
Official title: Real-World Evidence of Anticoagulation Treatment In Non-Valvular Atrial Fibrillation In Italy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anticoagulation
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2016-10-03
Enrollment: 9914
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study will include adults with NVAF who are newly prescribed apixaban, rivaroxaban, dabigatran, and VKA in 10 Italian Local Health Units (LHUs), during the study period, and meet the inclusion and exclusion criteria.

Brief summary: To quantify rates of bleeding events and investigate the characteristics of prescribed patients, rates of bleeding events, persistence and healthcare resource utilization of Oral Anticoagulants (OACs) prescribed in routine clinical practice.


Eligibility criteria: Inclusion Criteria:

* are at least 18 years of age at index date
* Initiated new OAC therapy ( no previous prescriptions of the same index OAC in the last 12 months prior to the index date ) during the study period
* Had at least 1 claim with diagnosis of AF anytime in their records

Exclusion Criteria:

* Have a record that is indicative of Valvular Atrial Fibrillation during this period
* Have a history of the OACs prescribed during the study period as assessed during the period of data availability(i.e. history of index OAC, as patients need to be newly prescribed either apixaban, rivaroxaban, dabigatran or VKA)
* Have more than one OAC exposure which starts on the same date

Primary outcomes:
measure: Incidence of clinically relevant bleeding events among Non-valvular atrial fibrillation (NVAF) patients following treatment initiation on an oral OAC in Italy
timeFrame: Approximately 30 months
Secondary outcomes:
measure: Distribution of patient demographics at the time of OAC initiation
timeFrame: at baseline
measure: Distribution of clinical characteristics at the time of OAC initiation
timeFrame: at baseline
measure: Composite of number and percentage of patients who are persistent with their newly prescribed OAC
timeFrame: Approximately 30 months
measure: Incidence of major bleeding events following treatment initiation among NVAF patients following treatment initiation on an oral OAC in Italy
timeFrame: Approximately 30 months
measure: Composite of number and percentage of patients with major bleeding events, thromboembolic events, or death while exposed to the newly prescribed OAC
timeFrame: Approximately 30 months
Other outcomes:
Locations:
city: Ravenna
country: Italy
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT01075126: Safety Study of Depakote Versus Lithium in African Americans With Bipolar Disorder
Official title: Depakote Vs. Lithium in African Americans With Bipolar Disorder
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Bipolar Disorder
Keywords: bipolar affective disorder
African American
antimanic
lithium
depakote
Lead sponsor: Lawson, William B., M.D., PhD, DFAPA
Sponsor class: INDIV
Collaborators: name: Abbott
First posted: 2010-02-24
Enrollment: 50
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: It is hypothesized that Depakote will be better tolerated then lithium in treating African Americans with bipolar disorder.

Detailed description: This is a 14 week randomized open study of 50 inpatients or outpatients with bipolar I r II. African American subjects will receive lithium or depakote ER. Measures will be made of psychopathology, reported side effects, and study completers. Measures will also be made of RBC/plasma lithium to determine if this level is better predictive of lithium tolerability.

Eligibility criteria: Inclusion Criteria:

* Male or female
* Females must be using a contraceptive
* Understand and sing informed consent
* Meet criteria for DSM IV bipolar I or II
* Must have been receiving treatment with depakote or lithium for at least 4 weeks
* Must not have used illicit substances 48 hours before the study

Exclusion Criteria:

* Not takin g lithium o valproate at time of screening
* Alcohol intoxicated or using drugs of abuse other then cannibis
* Presence of psychotic features
* Participation in clinical trail within 1 month of study
* Female subjects pregnant or nursing
* Serious unstable medical or psychiatric illness
* Uncorrected hypothyroidism or hyperthyroidism
* Seizures without a clear and resolved etiology
* Hypersensitivity or intolerance to lithium or valproic acid
* Treatment with injectable depot neuroleptic less then one dosing interval
* Treatment with reversible MAOI, guanethidine, or guanadrel within i week of study
* Treatment with fluoxetine within 8 weekS of study
* treatment with clozapine or ECT 3 months prior to study
* current diagnosis of schizophrenia or other psychotic disorder
* judged to be at serious suicidal risk

Primary outcomes:
measure: psychopathology: YMRS, MADRS
measure: Tolerability: Uku side effect rating, drop out rate, failure to switch rate
Secondary outcomes:
measure: HAMD, CGI-BP, HAM A,CORE, MADRS
Other outcomes:
Locations:
city: Washington
country: United States
facility: Howard University Hospital
state: District of Columbia
Study officials:
affiliation: Professor and Chair, Howard University College of Medicine
name: William B. Lawson, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05918926: Digitally Delivered Exercise in Helping People to Move More
Official title: Salaso Moving More: The Impact of Digitally Delivered Precision Exercise in Helping People to Move More
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Keywords: Physical activity
Lead sponsor: Bangor University
Sponsor class: OTHER
Collaborators: name: Betsi Cadwaladr University Health Board
name: Salaso Health Solutions Ltd
First posted: 2023-06-26
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The main objective of this study is to examine the influence of the digital exercise prescription platform in increasing habitual physical activity in people on a weight management programme.

Detailed description: Participants will be provided with individualised exercise training from exercise specialists. Participants will be recruited from the BCUHB NHS KindEating programme for people who have obesity (BMI of \>30 kg/m2). Participants will be recruited remotely, via their KindEating dietitian. The assessments and exercise programme will be conducted remotely in the participants' own home.

Eligibility criteria: Inclusion Criteria:

* Enrolled into the KindEating programme with BCUHB
* ≥ 18 years of age
* Able to provide written informed consent

Exclusion Criteria:

* Any uncontrolled medical condition that is exacerbated by exercise
* Unstable angina, unstable or acute heart failure, new or uncontrolled arrhythmias, resting or uncontrolled tachycardia, uncontrolled hypertension \>180/100 (in either), symptomatic hypotension, febrile illness, acute uncontrolled psychiatric illness, other rapidly progressing terminal illness, uncontrolled diabetes \>16.7mmol, patient's currently undergoing anti-biotic treatment for cellulitis, acute infections active foot ulceration
* Inability to provide informed consent

Primary outcomes:
measure: Habitual physical activity
timeFrame: Change between baseline and 3 months (post intervention)
Secondary outcomes:
Other outcomes:
Locations:
city: Bangor
country: United Kingdom
facility: Betsi Cadwaladr University Health Board
state: North Wales
Study officials:
affiliation: Bangor University
name: Sophie E Harrison, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02308826: Multi-Component Early Intervention for Socially Inhibited Preschool Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Behavioral Inhibition
Anxiety
Lead sponsor: University of Maryland, College Park
Sponsor class: OTHER
First posted: 2014-12-04
Enrollment: 169
Sex: ALL
Minimum age (years): 45
Maximum age (years): 64
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This project is intended to provide a rigorous test of the Turtle Program, an early intervention program for behaviorally inhibited preschoolers. The proposed project will extend promising pilot study findings by: (a) evaluating the integrated intervention in a larger sample (n = 150) of 45-64 month children and their parents, which will allow for an examination of mediators and moderators of treatment effects; (b) comparing the Turtle Program to the best available treatment for preschool behavioral inhibition, the Cool Little Kids (CLK) parent psychoeducation group; (c) examining heart rate reactivity and regulation as both baseline moderators of treatment response and as outcome measures; (d) examining parent anxiety disorders as a moderator of treatment response; (e) including a mid-treatment assessment and extending follow-up to one year.


Eligibility criteria: Inclusion Criteria:

* child must be attending preschool; child must score within top 15% on parent-rated Behavioral Inhibition Questionnaire

Exclusion Criteria:

* child has a diagnosis of pervasive developmental disorder, selective mutism, or mental retardation; child scores above clinical cutoff on Social Communication Questionnaire; child is currently receiving treatment for anxiety; child does not have a custodial parent who has also consented to participate

Primary outcomes:
measure: Change in child anxiety disorder symptoms
timeFrame: pre-treatment, mid-treatment (week 4), post-treatment (week 8), and 1-year follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: College Park
country: United States
facility: Maryland ADHD Program
state: Maryland
Study officials:
affiliation: University of Maryland
name: Andrea Chronis-Tuscano, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Maryland
name: Kenneth Rubin, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chronis-Tuscano A, Novick DR, Danko CM, Smith KA, Wagner NJ, Wang CH, Druskin L, Dougherty LR, Rubin KH. Early intervention for inhibited young children: a randomized controlled trial comparing the Turtle Program and Cool Little Kids. J Child Psychol Psychiatry. 2022 Mar;63(3):273-281. doi: 10.1111/jcpp.13475. Epub 2021 Jun 29.
Clinical trial NCT05876026: MRI T1 Relaxation Time in Rectal Cancer
Official title: MRI T1 Relaxation Times in Evaluating Neoadjuvant Treatment of Rectal Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rectal Cancer
Locally Advanced Rectal Carcinoma
Lead sponsor: Vejle Hospital
Sponsor class: OTHER
First posted: 2023-05-25
Enrollment: 108
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: People with rectal cancer (\>18 years of age) and no previous history of radiochemotherapy. The population will consist of people from the Region of Southern Denmark.

Brief summary: The goal of this observational study is to learn about the T1 relaxation time and T1 relaxation time properties of the disease in people with locally advanced rectal cancer. The main question it aims to answer is:

Does MRI T1 relaxation time have a high diagnostic performance in recognizing fibrosis as a complete response to neoadjuvant treatment of rectal cancer?

Participants will receive standard neoadjuvant treatment and be part of the standard examination programme regarding rectal cancer.


Eligibility criteria: Inclusion Criteria:

* rectal cancer, age \>18 years

Exclusion Criteria:

* contraindications for MRI (pacemaker, claustrophobia, implanted medical injectors and nerve stimulators),
* previous radiochemotherapy or another disease which investigator judges inappropriate for the persons continued participation.

Primary outcomes:
measure: Difference in T1 relaxation time (ms) in the rectal cancer tumor measured in IntelliSpace-software before and after neoadjuvant radiochemotherapy.
timeFrame: 6 to 8 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Vejle
country: Denmark
facility: Vejle Hospital
state: Jylland
Study officials:
affiliation: Vejle Hospital
name: Søren Rafaelsen, DMSc
role: STUDY_CHAIR
References:
Clinical trial NCT03061526: Spectral-domain Optical Coherence Tomography Findings in Retinal Vessel Occlusion
Official title: Spectral-domain Optical Coherence Tomography Findings in Retinal Vessel Occlusion - A Pilot Study of Detecting Ischemia in OCT
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Retinal Ischemia
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
First posted: 2017-02-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chart Review of patients treated b/o retinal vessel occlusion, who were examined with optical coherence tomography

Brief summary: Retinal vessel occlusions might lead to ischemia of the inner retina, more severe so in artery occlusions. Intracellular edema may develop and decrease transparency of those layers, showing retinal edema. In spectral domain optical coherence tomography (SD-OCT) retinal reflectivity changes as a result of retinal edema. The investigators examine the reflectivity changes of different retinal layers between healthy eyes and eyes with retinal artery occlusion and ischemic or non-ischemic vein occlusions. Aim of the study is to evaluate whether those changes can be used to measure the level of ischemia in the inner retina.

Detailed description: Several studies tried to classify retinal ischemia due to retinal artery or vein occlusion into different grades. In some cases prognosis is dependent on grade of severity, especially in cases of retinal vein occlusion. State of the art to Diagnose the severity of retinal ischemia is lfuorescein angiography. However, this technique is invasive and might cause Problems like anaphylactic shock. Optical coherence tomography is a non-invasive technique, but up to now there is no standardized method to quantify the grade of severity of retinal ischemia in such conditions like retinal vessel occlusion. The study hope to find criteria by which such a classification can be constructed.

Eligibility criteria: Inclusion Criteria:

* acute Retinal vessel occlusion on one eye
* healthy contralateral eye
* examined with spectral Domain optical coherence tomography

Exclusion Criteria:

* retinal occlusion older than 1 week
* OCT Image not obtainable/missing

Primary outcomes:
measure: reflectivity
timeFrame: December 2017
Secondary outcomes:
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: University Eye Hospital
Study officials:
affiliation: Technical University Dresden
name: Egbert Matthé, MD
role: PRINCIPAL_INVESTIGATOR
References: