louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01021189: Study to Assess Safety, Tolerability and Pharmacokinetics After Single and Multiple Doses of AZD1446 to Japanese Subject
Official title: A Phase I, Randomised, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD1446 in Healthy Young and Elderly Japanese Volunteers After Oral Single and Multiple Ascending Doses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: safety
tolerability
AZD1446
AD
Japanese
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-11-26
Enrollment: 97
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The primary aim of this study is to assess the safety and tolerability of AZD1446 following single and multiple ascending doses of an orally administered solution of AZD1446 in healthy young and elderly Japanese subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy Japanese subjects, aged ≥20 to ≤50 years for male young subjects, ≥65 to ≤80 years for male or post-menopausal female elderly subjects.
* BMI between 18 and 27 kg/m2 and weigh at least 50 kg and no more than 90 kg (for the elderly female, weigh at least 45 kg and no more than 90 kg).

Exclusion Criteria:

* History of Quincke oedema or angiooedema, or history of repeated episodes of urticaria.
* History or present symptoms or signs of asthma, airway hyperreactivity or obstructive lung disease.

Primary outcomes:
measure: To assess the safety and tolerability of AZD1446 following single and multiple ascending doses of an orally administered solution of AZD1446 in healthy young and elderly Japanese subjects by adverse events, vital signs, laboratory variables and ECG.
timeFrame: During the whole study period, ca. 50 days.
Secondary outcomes:
measure: To determine pharmacokinetics(PK) of AZD1446 following single and multiple dosing of AZD1446 in healthy young and elderly Japanese subjects.
timeFrame: PK sampling taken at defined timepoints during residential period, 12 days.
Other outcomes:
Locations:
city: Fukuoka
country: Japan
facility: Research Site
Study officials:
affiliation: AstraZeneca R&D Södertälje
name: Björn Paulsson, MD, PhD
role: STUDY_DIRECTOR
affiliation: Kyusyu Clinical Phramacology Research Clinic
name: Shunji Matsuki, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04597489: Fractional FLOw Reserve In Cardiovascular DiseAses
Official title: Fractional FLOw Reserve In Cardiovascular DiseAses
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Acute Coronary Syndrome
Lead sponsor: LinkCare GmbH
Sponsor class: INDUSTRY
Collaborators: name: Abbott
name: Charite University, Berlin, Germany
name: University Hospital, Zürich
name: University Hospital Schleswig-Holstein
name: Ruhr University of Bochum
First posted: 2020-10-22
Enrollment: 64045
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Out of a dataset of 4,395,540 anonymized age- and sex-stratified people from an anonymized German health claims database, patients undergoing at least one inpatient coronary angiography for suspected coronary artery disease between January 2014 and December 2015 were included in the analysis. The discharge date of the first hospital stay involving a coronary angiography was defined as the patient's individual index date. Patients were included into the study population regardless of their underlying disease (all-comers approach), if they were observable for at least four years (one year prior the time of inclusion and three years after the time of inclusion), or died within follow-up.

Brief summary: The FLORIDA (Fractional FLOw Reserve In cardiovascular DiseAses) study sought to investigate outcomes of FFR-guided versus angiography-guided treatment strategies in a large, real-world cohort.

Detailed description: The objective of the FLORIDA study was to investigate mortality outcomes of FFR-guided versus angiography-guided treatment strategies in a large, real-world patient cohort, including patients with different stages of coronary artery disease as well as patients with acute coronary syndrome (ACS). All patients were followed for a period of 3 years after the index date. The analysis period extended from the individual index date to the date of death or the end of the 3-year follow-up period. Patients were matched for sex, presence of acute coronary syndrome, age ± 5 years, and propensity scores estimated with logistic regression based on 72 variables , with each FFR patient matched to the closest angiography-only patient

Eligibility criteria: Inclusion Criteria:

* At least one inpatient coronary angiography for suspected coronary artery disease between January 2014 and December 2015.

Exclusion Criteria:

* Loss to follow-up of other reasons than death (i.e. change of insurance)

Primary outcomes:
measure: All-cause mortality
timeFrame: 36 months
Secondary outcomes:
measure: All-cause mortality
timeFrame: 12 months
measure: All-cause mortality
timeFrame: 24 months
Other outcomes:
Locations:
city: Stuttgart
country: Germany
facility: LinkCare GmbH
Study officials:
affiliation: LinkCare GmbH
name: Tobias Vogelmann, MSc
role: STUDY_CHAIR
References:
Clinical trial NCT04771689: Buprenorphine/Naloxone Micro-Dosing for Postoperative Pain Management in Opioid-Tolerant Patients
Official title: Assess the Efficacy of Buprenorphine/Naloxone Micro-Dosing for Postoperative Pain Management in Opioid-Tolerant Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Post-operative Pain
Keywords: pain
pain management
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2021-02-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized clinical study evaluating the effect of buprenorphine/naloxone (bup/nx) sublingual film on postoperative pain management in opioid-tolerant patients.


Eligibility criteria: Inclusion Criteria:

1. Opioid tolerance, defined as the daily use of greater than or equal to 60mg of oral morphine or an equianalgesic dose of any other opioid for more than 7 days immediately prior to the surgery
2. Undergoing orthopedic or general surgery
3. 18 years of age or older
4. Willing and able to adhere to the study protocol and follow-up schedule
5. Able to provide written informed consent to participate in the clinical trial
6. If female and of childbearing potential, agree to use an effective method of birth control approved by the study investigators throughout the study

Exclusion Criteria:

1. Buprenorphine or buprenorphine/naloxone use in the last two weeks
2. Patients receiving pre-, intra-, or post-operative regional blocks or neuraxial anesthesia
3. Patients receiving postoperative ketamine or lidocaine boluses or infusions
4. Patients receiving postoperative nonsteroidal anti-inflammatory drugs (NSAIDs) for pain control
5. Diagnosis of severe medical or psychiatric conditions contraindicated for bup/nx treatment
6. Liver disease, including clinically significant transaminitis, active hepatitis infection, cirrhosis with evidence of impaired synthetic function
7. Anticipated deterioration of health due to discontinuation of medications that are contraindicated with bup/nx
8. Positive pregnancy test for women of childbearing potential
9. Known allergy or sensitivity to bup/nx
10. Anticipation that the subject may need to initiate pharmacological treatment during the trial that is deemed unsafe by the study physician or could prevent study completion
11. Current participation in additional pharmacologic research study
12. Active suicidal ideation as determined by PI or study clinician

Primary outcomes:
measure: Postoperative Pain Scores
timeFrame: through study completion, an average of 6 days
measure: Postoperative Opioid Consumption
timeFrame: through study completion, an average of 6 days
measure: Length of Hospital Stay
timeFrame: through study completion, an average of 6 days
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Karina de Sousa
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Yi Zhang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04503889: The Effect of Transauricular Electrical Vagal Nerve Stimulation on Temporal Summation of Pain in Patients With Back Pain
Official title: The Effect of Transauricular Electrical Vagal Nerve Stimulation on Temporal Summation of Heat Pain in Patients With Chronic Low-back Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain Intensity
Lead sponsor: University Medicine Greifswald
Sponsor class: OTHER
First posted: 2020-08-07
Enrollment: 60
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The effect of transauricular electrical vagal nerve stimulation (taVNS) will be studied on temporal summation of heat pain (TSP) in 30 patients with chronic low-back pain and in 30 heathy volunteers. Participants will receive either taVNS or sham stimulation before and during TSP induction in a randomized crossover manner. The participants will be unaware regarding the type of intervention.


Eligibility criteria: Inclusion Criteria:

* Patients with chronic low-back pain
* age 30-60 yrs old
* without heart disease
* low-back pain intensity at least 4 out of 10 points measured using NRS-10
* without cognitive deficits (Mini Mental State Shake \< 23)

Exclusion Criteria:

* opioid medication
* more than 1 low-back surgery
* sensory of motor neurological deficits at the level of back pain
* spinal stenosis
* diabetic polyneuropathy
* skin pathology at the site (cymba conchae) of stimulation

Primary outcomes:
measure: Unpleasantness of pain
timeFrame: Continuously 5 minutes during the experimental heat pain stimulation
Secondary outcomes:
measure: Heart rate
timeFrame: 10 minutes (before, during and after stimulation of heat pain)
measure: blood pressure
timeFrame: 10 minutes (before, during and after stimulation of heat pain)
Other outcomes:
Locations:
city: Greifswald
country: Germany
facility: University Medicine of Greifswald
Study officials:
affiliation: University Medicine of Greifswald
name: Taras Usichenko, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00715689: Dose Study in Growth Hormone Deficient Adults Investigating Safety, Pharmacokinetics and Pharmacodynamics of NNC126-0083
Official title: Dose Study Investigating Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of NNC126-0083 in Growth Hormone Deficient Adults (GHDA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Growth Hormone Disorder
Adult Growth Hormone Deficiency
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2008-07-15
Enrollment: 33
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of NNC126-0083 in growth hormone deficient adults


Eligibility criteria: Inclusion Criteria:

* GHDA subjects as defined in the Consensus guidelines for the diagnosis and treatment of adults with GH deficiency II
* Fertile females must agree to use appropriate contraceptive methods and have a negative pregnancy test at inclusion
* GH replacement therapy for more than 3 months
* Body Mass Index (BMI, kg/m2) of 22.0 to 35.0 kg/m2, both inclusive

Exclusion Criteria:

* Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods
* Malignant disease
* Proliferative retinopathy judged by retina-photo within the last year - only with concomitant diabetes
* Heart insufficiency, NYHA class greater than 2
* Subjects with diabetes with an HbA1C above 8.0%
* Diabetic receiving insulin treatment
* Stable pituitary replacement therapy for less than 3 months
* Impaired liver function
* Impaired kidney function

Primary outcomes:
measure: Safety and tolerability (adverse events, local tolerability, physical examination)
timeFrame: 0 to 10 days after third dosing, (day 15-25 after first dose)
Secondary outcomes:
measure: Cmax, maximum concentration of IGF-I
timeFrame: after trial product administration
Other outcomes:
Locations:
city: København Ø
country: Denmark
facility: Novo Nordisk Investigational Site
city: Odense
country: Denmark
facility: Novo Nordisk Investigational Site
city: Århus C
country: Denmark
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Sondergaard E, Klose M, Hansen M, Hansen BS, Andersen M, Feldt-Rasmussen U, Laursen T, Rasmussen MH, Christiansen JS. Pegylated long-acting human growth hormone possesses a promising once-weekly treatment profile, and multiple dosing is well tolerated in adult patients with growth hormone deficiency. J Clin Endocrinol Metab. 2011 Mar;96(3):681-8. doi: 10.1210/jc.2010-1931. Epub 2010 Dec 22.
Clinical trial NCT03484689: MBCT for DM Distress: a Pilot Qusai-experimental Study
Official title: Mindfulness-based Cognitive Therapy (MBCT) for Type II Diabetes Mellitus (DM) Patients With High Diabetes Distress and Suboptimal DM Control: a Pilot Qusai-experimental Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes-related distress
Mindfulness
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2018-04-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Background: Diabetes-related distress (DRD) is very common among people with type II diabetes mellitus (DM). DRD led to poorer DM control and may led to adverse prognosis. Yet, there is no widely accepted or recommended DRD treatment.

Mindfulness was shown to relieve psychological distress in various physical and mental conditions.

Aim: as a pilot project, we aim to determine if mindfulness-based cognitive therapy (MBCT), which is one of the widely used mindfulness program, is feasible and acceptable and may improve DRD in our Chinese population.

Method: 20 Chinese participants with suboptimally controlled DM and high DRD will be recruited to a 8- week MBCT group. Pre-group and post-group (immediate and 2-month post-group) data including DRD score, quality-of life measures will be compared.


Eligibility criteria: Inclusion Criteria:

* received a clinical diagnosis of type II DM
* aged \>=18
* can provide valid consent
* can speak Cantonese
* can read and write simple Chinese
* HbA1c \>7%
* have CDDS score \>=3

Exclusion Criteria:

* diagnosed active mental illness
* have severe hearing loss
* non-Chinese
* have active suicidal ideation as screened by Q9 of PHQ-9
* unwilling to join at least 6 out of 8 session of MBCT
* received mindfulness training in the past year or having regular mindfulness practice
* received psychotherapy last year
* severe physical illness limiting them from coming repeatedly to the group

Primary outcomes:
measure: Rate of recruitment
timeFrame: From recruitment (1 April) till 20 patients are recruited (within 1 month)
measure: Dropout rate
timeFrame: Week 1 (start of MBCT, intervention) till week 8
Secondary outcomes:
measure: Chinese Version of Diabetes Distress Scale (CDDS-15)
timeFrame: At pre-group (week1), immediate post-group (week8) and 2 months post-group (week16)
measure: 9-item patient Health Questionnaire (PHQ-9)
timeFrame: At pre-group (week1), immediate post-group (week8) and 2 month post-group (week16)
measure: The Audit of Diabetes-Dependent Quality of Life (ADDQOL)
timeFrame: At pre-group (week1), immediate post-group (week8) and 2 month post-group (week16)
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Pok Oi Hopsital
Study officials:
References:
Clinical trial NCT02876289: Retrospective Evaluation of Perampanel in a French Neurology and Epileptology Department (Hospices Civil de Lyon)
Official title: Retrospective Evaluation of Perampanel in a French Neurology and Epileptology Department (Hospices Civil de Lyon)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Refractory Epilepsy
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-08-23
Enrollment: 110
Sex: ALL
Minimum age (years): 16
Maximum age (years): 86
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with refractory focal epilepsy in which Perampanel were introduced between May 2014 and April 2015

Brief summary: Perampanel is a non-competitive antagonist of the AMPA ( 2-amino-3-(5-méthyl-3-hydroxy-1,2-oxazol-4-yl)) propanoïc acid receptors which was approved by the European Medicines Agency as adjunctive treatment for partial-onset seizures in patients 12 years and older, in 2012. The aim of this study is to evaluate effectiveness and safety of perampanel as add-on treatment in patients with refractory epilepsy.

The investigators retrospectively collected and analyzed the data of patients with refractory epilepsy who had been treated with perampanel between May of 2014 and April of 2015. In total, one hundred and ten patients were included (mean age 41 \[SD = 15.2\]). The mean duration of epilepsy was 25 years (SD = 14.4). The mean perampanel dose was 5.7 mg/d (SD = 2.3). The retention rate was 77% at 6 months and 61% at 12 months. After 6 months, the responder rate was 35.5%. Eight patients (7.3%) became seizure free. Adverse effects were reported in 60 patients (54.5%). Most common side effects were behaviour disturbance (22.7%), dizziness (15.5%), asthenia (11.8), somnolence (10%) and ataxia (9.1).


Eligibility criteria: Inclusion Criteria:

* Patients with refractory focal epilepsy
* Initiation of perampanel between 05/2014 and 04/2015

Exclusion Criteria:

* Exact date of initiation of Perampanel not defined
* Patients without follow-up data

Primary outcomes:
measure: Retention rate
timeFrame: 6 months
Secondary outcomes:
measure: Retention rate
timeFrame: 12 months
measure: Seizure freedom
timeFrame: 6 months
measure: Responder rates
timeFrame: 6 months
measure: Responder rates
timeFrame: 12 months
measure: Total withdrawal rate
timeFrame: 6 months
measure: Total withdrawal rate
timeFrame: 12 months
measure: Observed adverse effects during the observation period
timeFrame: 12 months
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital neurologique
Study officials:
affiliation: Hospices Civils de Lyon
name: Sylvain RHEIMS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00026689: Evaluation for NCI Radiation Oncology Branch Clinical Research Protocols
Official title: Evaluation for NCI Radiation Oncology Branch Clinical Research Protocols
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate
Brain
Breast
Lung
Endometrial
Keywords: Evaluation
Screening
Cancer
Radiation
Eligibility
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2001-11-15
Enrollment: 903
Sex: ALL
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL

Brief summary: Background:

-This protocol will provide a means for screening potential candidates for NCI Radiation Oncology Branch (ROB) protocols.

Objectives:

-To permit evaluation of patients referred to the NCI Radiation Oncology Branch in order to identify individuals who will be suitable candidates for Radiation Oncology Branch clinical research protocols.

Eligibility:

-Patients suspected of having, or with biopsy proven malignant disease or patients with a benign condition for whom radiotherapy is a potential treatment.

Design:

-This is a screening protocol. No investigational treatments will be administered on this protocol.

Detailed description: Background:

-This protocol will provide a means for screening potential candidates for NCI Radiation Oncology Branch (ROB) protocols.

Objectives:

-To permit evaluation of patients referred to the NCI Radiation Oncology Branch in order to identify individuals who will be suitable candidates for Radiation Oncology Branch clinical research protocols.

Eligibility:

-Patients suspected of having, or with biopsy proven malignant disease or patients with a benign condition for whom radiotherapy is a potential treatment.

Design:

-This is a screening protocol. No investigational treatments will be administered on this protocol.

Eligibility criteria: * INCLUSION CRITERIA:

Patients suspected of having, or with biopsy proven malignant disease or patients with a benign condition for whom radiotherapy is a potential treatment.

Patient or guardian is able to provide informed consent.

EXCLUSION CRITERIA:

Candidates who do not meet the inclusion criteria.

Primary outcomes:
measure: To permit evaluation of patients referred to the NCI Radiation Oncology Branch in order to identify individuals who will be suitable candidates for Radiation Oncology Branch clinical research protocols.
timeFrame: Completion of study
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center, 9000 Rockville Pike
state: Maryland
Study officials:
affiliation: National Cancer Institute (NCI)
name: Kevin A Camphausen, M.D.
role: PRINCIPAL_INVESTIGATOR
References: