louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04813458: A Multi-centre Survey on Tramadol Abuse in Singapore
Official title: A Multi-centre Survey on Tramadol Abuse in Singapore
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Opioid Abuse
Lead sponsor: Singapore General Hospital
Sponsor class: OTHER
First posted: 2021-03-24
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who attends pain clinic in SGH, SKGH and CGH.

Brief summary: The rampant prescription of opioid has in part contributed to the ongoing worldwide opioid crisis. In the United States of America, it is estimated that death from the use of opioids outnumber death from motor vehicle accident deaths by more than 40%. Consequently, many countries such as America and Canada have drawn up guidelines pertaining to safe opioid prescribing.

Tramadol is often used by pain physicians to treat chronic pain. As it is a weak opioid and unscheduled in many countries, it is often considered to have a lower addiction potential compared to strong opioids. Despite this, the literature does reveal evidence of abuse, addiction and withdrawal - although the incidence of this is unclear.

In this study, the investigators aim to determine the prevalence of tramadol misuse in a pain clinic population. The investigators also aim to determine the real-life compliance of physicians to guidelines provided by International regulatory bodies (CDC) and the modifiable risk factors associated with tramadol misuse.


Eligibility criteria: Inclusion Criteria:

* All patients attending pain clinic in Singapore General Hospital, Seng Kang General Hospital and Changi General Hospital

Exclusion Criteria:

-

Primary outcomes:
measure: Current Opioid Misuse Measure (COMM)
timeFrame: Baseline
Secondary outcomes:
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Baseline
measure: General Anxiety Disorder-7 (GAD-7)
timeFrame: Baseline
measure: Opioid Risk Tool (ORT)
timeFrame: Baseline
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Changi General Hospital
city: Singapore
country: Singapore
facility: Seng Kang General Hospital
city: Singapore
country: Singapore
facility: Singapore General Hospital
Study officials:
References:
Clinical trial NCT06281158: A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-DNL343 Following a Single Oral Dose in Healthy Male Participants
Official title: A Study of the Pharmacokinetics of [14C]-DNL343 Following a Single Oral Dose in Healthy Male Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Denali Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2024-02-28
Enrollment: 7
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a Phase 1, open-label, nonrandomized, single-dose study in healthy male participants to investigate the absorption, metabolism and excretion of DNL343.


Eligibility criteria: Inclusion Criteria:

* Males, aged between 18 to 65 years, inclusive
* Body mass index between 18.0 and 32.0 kg/m2
* In good health
* When engaging in sex with a woman of child bearing potential, both the male participant and his female partner must use highly effective contraception
* History of a minimum of 1 bowel movement per day

Exclusion Criteria:

* History or clinical manifestation of any clinically significant metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder
* Have a history of malignancy, except fully resected basal cell carcinoma
* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance
* History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs
* Have previously completed or withdrawn from this study or any other study investigating DNL343 and have previously received DNL343

Primary outcomes:
measure: PK Parameter: AUC0-∞
timeFrame: 28 days
measure: PK Parameter: AUC0-tlast
timeFrame: 28 days
measure: PK Parameter: Cmax
timeFrame: 28 days
measure: PK Parameter: Tmax
timeFrame: 28 days
measure: PK Parameter: t1/2
timeFrame: 28 days
measure: Total radioactivity in plasma and whole blood
timeFrame: 28 days
measure: Total radioactivity in blood-to-plasma ratio
timeFrame: 28 days
measure: Extent and rate of recovery of total radioactivity in urine and feces
timeFrame: 28 days
Secondary outcomes:
measure: PK Parameter: AUC0-∞
timeFrame: 28 days
measure: PK Parameter: AUC0-tlast
timeFrame: 28 days
measure: PK Parameter: Cmax
timeFrame: 28 days
measure: PK Parameter: Tmax
timeFrame: 28 days
measure: PK Parameter: t1/2
timeFrame: 28 days
measure: DNL343 and a DNL343 metabolite recoveries in urine
timeFrame: 28 days
measure: Incidence, severity, and seriousness of treatment-emergent adverse events (TEAEs)
timeFrame: 28 days
Other outcomes:
Locations:
city: Madison
country: United States
facility: Clinical Site
state: Wisconsin
Study officials:
affiliation: Denali Therapeutics
name: Ana-Claire Meyer, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03686358: Evaluation of Renal Angioplasty on Atherosclerotic Stenosis Since 2010
Official title: Evaluation of Renal Angioplasty on Atherosclerotic Stenosis Since 2010
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Angioplasty on Atherosclerotic Stenosis
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2018-09-26
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients having undergone renal arterial angioplasty on atherosclerotic stenosis between 01/01/2010 and 12/31/2013 at Rennes University Hospital

Brief summary: The interest of renal angioplasty in the nosological framework of atherosclerotic stenosis has been significantly challenged by STAR and ASTRAL clinical trials in 2009, confirmed by the CORAL study in 2014.

These studies did not show any benefit of the gesture on renal function, morbidity and cardiovascular mortality or the tension control. The aim of the study is to evaluate renal angioplasty on atherosclerotic stenosis.

Detailed description: Previous studies did not concern the indication of renal angioplasty in some high-risk situations, such as malignant or resistant renal vascular hypertension, OAP (Acute pulmonary oedema) flash or acute renal failure of ischemic origin.

There is no work in the literature that has studied retrospectively the evolution of angioplasty practices renal artery disease on atherosclerotic stenosis since 2009, nor their remote results of the gesture.

Eligibility criteria: Inclusion Criteria:

* OAP flash: hospitalization for Acute congestive heart failure without any other identified etiology than renal artery stenosis
* Resistant arterial hypertension under treatment including a diuretic
* Acute renal failure or ischemic renal failure quickly progressive
* Radiological criteria: renal ischemia visualized at arterial time of angio-CT or renal angio-MRI

Exclusion Criteria:

* Renal transplant patients
* Patients with another etiology of secondary hypertension, including fibro-muscular dysplasia of renal artery
* Restenosis on stent, angioplasty of accessory renal artery
* Patients subject to legal protection (safeguard of justice, guardianship) and persons deprived of liberty
* Patients objecting to participate to the study

Primary outcomes:
measure: Composite endpoint at 3 years
timeFrame: The inclusion day
Secondary outcomes:
Other outcomes:
Locations:
city: Rennes
country: France
facility: CHU Rennes
state: Bretagne
Study officials:
affiliation: CHU Rennes
name: Thierry FROUGET
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03968458: Effect of Exercise Timing on Energy Intake and Appetite in Adolescents With Obesity: the TIMEX 3 Study
Official title: Effect of Exercise Timing on Energy Intake and Appetite in Adolescents With Obesity: the TIMEX 3 Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pediatric Obesity
Keywords: appetite control
obesity
Adolescents
exercise timing
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: Laboratoire des Adaptations Métaboliques à l'Exercice en conditions Physiologiques et Pathologiques
First posted: 2019-05-30
Enrollment: 18
Sex: ALL
Minimum age (years): 12
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the present study is to compare the effect of the timing (30 vs. 90 minutes) between a fixed exercise and the following test meal on energy intake, appetite feelings and food reward in adolescents with obesity.

Detailed description: The present study will compare the nutritional response to the realisation of an acute exercise 90 minutes or 30 minutes before an ad libitum buffet meal in adolescents with obesity. 18 adolescents with obesity will be asked to randomly complete three experimental sessions: i) one control session (rest); ii) one session with an acute exercise realized 90 minutes before lunch; iii) one session with the same exercise performed 30 minutes before lunch. Their ad libitum energy intake will be assessed during lunch as well as at dinner time. Appetite feelings will be assessed at regular intervals and their food reward in response to the lunch will also be assessed.

Eligibility criteria: Inclusion Criteria:

* BMI percentile \> 97th percentile according to the french curves.
* ages 12-16 years old
* Signed consent form
* being registered in the national social security system
* no contraindication to physical activity

Exclusion Criteria:

* Previous surgical interventions that is considered as non-compatible with the study.
* Diabetes
* weight loss during the last 6 months
* cardiovascular disease or risks

Primary outcomes:
measure: Change of energy intake measured during an ad libitum buffet meal (in kcal).
timeFrame: day 1 , day 8, day 15
Secondary outcomes:
measure: Hunger feelings
timeFrame: day 1 , day 8, day 15
measure: Food reward
timeFrame: day 1 , day 8, day 15
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: yves Boirie
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00396058: The Effect of Methylphenidate on Motor Learning in Stroke Patients
Official title: Methylphenidats Betydning for motoriskindlæring Hos Patienter Med Apopleksi
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Cerebrovascular Accident
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2006-11-06
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine whether methylphenidate facilitates so called short-term plasticity as measures with transcranial magnetic stimulation, in patients with stroke.

Detailed description: Stroke patients are to be examined with transcranial magnetic stimulation (TMS) before and after a short training session. TMS will be used to demonstrate changes in cortical excitability (motor threshold) and intracortical inhibition and facilitation. The effect of methylphenidate on baseline TMS measures will be evaluated as well as the effect on training induced changes in TMS measures (by comparing baseline and posttraining measures). The patients will be trained on two separate occasions, to compare the effect of Methylphenidate to placebo.

Eligibility criteria: Inclusion Criteria:

* Less than two months after first stroke.
* Moderate to light hand paralysis
* Measurable MEP in the abductor pollicis brevis muscle
* Able to read and understand the written information
* Signed informed consent

Exclusion Criteria:

* Epilepsy
* Glaucoma
* Hyperthyroidism
* Cardiac arrythmia
* Known heart disease or angina.
* Metal implants
* Pacemaker
* Pregnancy
* Diastolic BP\>100 mmHg
* In treatment with MAO-inhibitor, SSRIs og Ritalin

Primary outcomes:
measure: Training induced changes in Short interval Intracortical Inhibition (SICI).
measure: Training induced changes in Intracortical facilitation (ICF)
Secondary outcomes:
measure: Baseline SICI, ICF, and motor threshold compared between methylphenidate and Placebo
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of neurology
city: Hammel
country: Denmark
facility: Hammel neurocenter
Study officials:
affiliation: Hammel neurocenter Aarhus University Hospital Denmark
name: Jakob U Blicher, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03405558: Performance Developement of Patients With Paraplegia During First Rehabilitation
Official title: Effects of an Individually Tailored Endurance Training on the Performance Developement of Patients With Paraplegia During First Rehabilitation: an Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Physical Activity
Lead sponsor: Swiss Paraplegic Research, Nottwil
Sponsor class: NETWORK
First posted: 2018-01-23
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with a paraplegia during the first rehabilitation

Brief summary: A high physical fitness is crucial for a good quality of life in persons suffering from a spinal cord injury. The aim of the present observational study is to investigate the influence of an individually tailored 8-week endurance training program on endurance performance of patients with a paraplegia during their first rehabilitation.


Eligibility criteria: Inclusion Criteria:

* Written informed consent
* male or female, paraplegia (AIS A-C, lesion Level Th1-Th12)
* Age 18-65 years
* Manual wheelchair user
* Patient during first rehabilitation

Exclusion Criteria:

* BMI ≥ 30
* unable to use an arm-crank Ergometer due to e.g. spasticity
* physical impairment, which makes it impossible to perform an arm-crank ergometry
* Progressive disease (g.g. tumor, MS)
* Ventilator dependent
* existing cardiopulmonary disease
* Unstable medical situation

Primary outcomes:
measure: Peak power
timeFrame: 10min
Secondary outcomes:
Other outcomes:
Locations:
city: Nottwil
country: Switzerland
facility: Swiss Paraplegic Centre
state: Lucerne
Study officials:
affiliation: Swiss Paraplegic Research, Nottwil
name: Claudio Perret
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00000358: Evaluation of Lofexidine for Treatment of Opioid Withdrawal - 7
Official title: Safety Evaluation of Lofexidine for Treatment of Opioid Withdrawal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Opioid-Related Disorders
Substance-Related Disorders
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: University of Pennsylvania
First posted: 1999-09-21
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety of lofexidine in the treatment of opiate withdrawal. Preliminary data will also be obtained to assess the ability of lofexidine to alleviate opiate withdrawal signs and symptoms.


Eligibility criteria: Please contact site for information.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: PDVAMC Treatment Research Center
name: Charles O'Brien, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01811758: Culturally Specific Interventions: African American Smokers
Official title: Culturally Specific Interventions and Acculturation in African American Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Smoking
Smoking Cessation
Keywords: Culturally Specific Cognitive Behavioral Therapy
Standard Cognitive Behavioral Therapy
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: University of Minnesota
First posted: 2013-03-15
Enrollment: 345
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The investigators expect that a culturally specific group intervention targeting African American smokers will result in greater smoking cessation rates compared to a standard intervention.


Eligibility criteria: Inclusion Criteria:

1. self-identification as African American
2. current smoker of ≥ 5 cigarettes/day or expired CO level of ≥ 8 ppm;
3. age 18-65;
4. able to speak and read English;
5. permanent contact information;
6. access to transportation by public transit or car;
7. no current behavioral or pharmacological treatment ;
8. interest in quitting smoking; (9) have availability to attend sessions.

Exclusion Criteria:

1. enrolled in another cessation program,
2. do not speak and read English,
3. do not have access to transportation by car or bus to attend sessions,
4. do not have childcare during session times,
5. have contraindications for patch use (pregnant/breastfeeding),
6. if they are in treatment for substance abuse (e.g., illicit drugs, alcohol abuse),
7. if they endorse active addiction to another substance (e.g., illicit drugs or alcohol),
8. if they have been diagnosed with an acute cardiac or respiratory condition;
9. people identified as having a severe mental illness

Primary outcomes:
measure: 7-day point prevalence abstinence
timeFrame: Overall effect at 12-months
Secondary outcomes:
measure: 7-day point prevalence abstinence
timeFrame: 6-months
Other outcomes:
Locations:
city: Coral Gables
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Monica Hooper, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hooper MW, Larry R, Okuyemi K, Resnicow K, Dietz NA, Robinson RG, Antoni MH. Culturally specific versus standard group cognitive behavioral therapy for smoking cessation among African Americans: an RCT protocol. BMC Psychol. 2013 Aug 21;1(1):15. doi: 10.1186/2050-7283-1-15. eCollection 2013.
Clinical trial NCT02850458: Clinical Results of Implant-retained Mandibular Overdentures in Edentulous Patients
Official title: Clinical Results of Implant-retained Mandibular Overdentures in Edentulous Patients: A 5-year Retrospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Edentulous
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2016-08-01
Enrollment: 54
Sex: ALL
Minimum age (years): 45
Maximum age (years): 83
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients treated with implant retained overdentures at the Department of Prosthodontics, School of Stomatology of the Fourth Military Medical University between July 2011 to May 2014.

Brief summary: The purpose of this study is to evaluate the clinical results of implant-retained mandibular overdentures in edentulous patients.

Detailed description: The survival of implants,condition of the peri-implant soft tissue were evaluated. And patients' perceptions regarding the outcome were assessed on visual analog scales (VAS), oral health impact profile-14 (OHIP) and semantic differential scale questionnaires.

Eligibility criteria: Inclusion Criteria:

1. Patients treated with implant retained overdentures
2. With the ability to read and sign the informed consent document

Exclusion Criteria:

1. Jaw radiotherapy treatment before and after implanting
2. Patients who suffered with mental and psychological disease will influence their oral health normal maintenance
3. Can not read and sign the informed consent document

Primary outcomes:
measure: Survival of implants
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Gingival Bleeding on Probing
timeFrame: through study completion, an average of 1 year
measure: Pocket depths
timeFrame: through study completion, an average of 1 year
measure: Marginal bone loss
timeFrame: through study completion, an average of 1 year
Other outcomes:
measure: patients' satisfaction
timeFrame: through study completion, an average of 1 year
measure: oral health-related quality of life
timeFrame: through study completion, an average of 1 year
Locations:
city: Xi'an
country: China
facility: Stomatological Hospital of Fourth Military Medical University
state: Shanxi
Study officials:
affiliation: IRB of Stomatological Hospital of FMMU,PLA
name: Yong jin chen
role: PRINCIPAL_INVESTIGATOR
References: