louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01137838: Changes in the Use of Opioids, Antidepressants, and Benzodiazepines in Rheumatoid Arthritis Patients Treated With Biologic Agents
Official title: Changes in the Use of Opioids, Antidepressants, and Benzodiazepines in Rheumatoid Arthritis Patients Treated With Biologic Agents
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2010-06-07
Enrollment: 1810
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: Commercial insurance claims database

Brief summary: To compare the proportion of rheumatoid arthritis (RA) patients prescribed opioids, benzodiazepines, and antidepressants before versus after starting each of the following biologics: abatacept, infliximab, etanercept, adalimumab, utilizing an administrative claims database.


Eligibility criteria: Inclusion Criteria:

* ICD 9 diagnosis RA 714.0
* Documented first biologic prescription ("index" prescription) for abatacept, infliximab, etanercept, or adalimumab
* Continuous therapy (gap between scripts no greater than 150% days supply) for minimum 6 months from index
* Prescription claims data available for 6 months before and 12 months after index biologic prescription
* Continuous eligibility for 6 months before and 12 months after index biologic prescription

Exclusion Criteria:

* Prescription claims for another biologic during the observation period (including rituximab and anakinra)
* Prescriptions not continuous for at least 6 months

Primary outcomes:
measure: Proportion of RA patients prescribed opioids, benzodiazepines, and antidepressants
timeFrame: 0-6 months after index biologic prescription
measure: Proportion of RA patients prescribed opioids, benzodiazepines, and antidepressants
timeFrame: 7-12 months after index biologic prescription
Secondary outcomes:
measure: Prevalence of depression and/or anxiety (ICD-9 diagnosis code)
timeFrame: Between 0-6 months after index biologic prescription
measure: Prevalence of depression and/or anxiety (ICD-9 diagnosis code)
timeFrame: 7-12 months after index biologic prescription
Other outcomes:
Locations:
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT00184938: Opioid Receptors Influence Ischemia-Reperfusion Injury
Official title: Opioid Induced Acute Preconditioning
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Ischemia-Reperfusion Injury
Keywords: opioids
ischemic preconditioning
morphine
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2005-09-16
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The most powerful protective mechanism against ischemia-reperfusion injury other than rapid reperfusion is ischemic preconditioning. Ischemic preconditioning is defined as the development of tolerance to ischemia-reperfusion injury by a previous short bout of ischemia resulting in a marked reduction in infarct size. This mechanism can be mimicked by several pharmacological substances such as adenosine and morphine.

We, the researchers at Radboud University Nijmegen Medical Centre, have recently developed a method in which we can detect ischemia-reperfusion injury in the human forearm by using Annexin A5 scintigraphy (Rongen et al). With this method we will determine whether opioid receptors are involved in ischemic preconditioning. We expect to find that morphine can mimic ischemic preconditioning and that acute ischemic preconditioning can be blocked with the opioid receptor antagonist naloxon. This study will increase our knowledge about the mechanism of ischemic preconditioning and may also provide leads to exploit this endogenous protective mechanism in a clinical setting.


Eligibility criteria: Inclusion Criteria:

* Healthy male volunteers

Exclusion Criteria:

* Exposition to radiation due to imaging techniques in the previous five years

Primary outcomes:
measure: Percentual difference in Annexin A5 targetting between the experimental and control arm 1 and 4 hours after intravenous injection
Secondary outcomes:
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Centre / Department of Pharmacology and Toxicology
state: Gelderland
Study officials:
affiliation: Radboud University Nijmegen Medical Centre / Department of Pharmacology and Toxicology
name: Gerard Rongen, MD, Phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rongen GA, Oyen WJ, Ramakers BP, Riksen NP, Boerman OC, Steinmetz N, Smits P. Annexin A5 scintigraphy of forearm as a novel in vivo model of skeletal muscle preconditioning in humans. Circulation. 2005 Jan 18;111(2):173-8. doi: 10.1161/01.CIR.0000151612.02223.F2. Epub 2004 Dec 27.
Clinical trial NCT01059838: Speech Perception for Children With Cochlear Implants
Official title: Speech Perception in Noise for Children With Cochlear Implants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hearing Loss
Keywords: pediatrics
cochlear implant
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2010-02-01
Enrollment: 30
Sex: ALL
Minimum age (years): 4
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine whether speech recognition in noise can be improved by the addition of a special listening program to the sound processor. Thus we propose to assess speech perception in noise for pediatric cochlear implant patients using both their everyday listening program as well an ASC program.

Detailed description: The purpose of this study is to determine whether speech recognition in noise can be improved by the addition of a special listening program to the sound processor. Thus we propose to assess speech perception in noise for pediatric cochlear implant patients using both their everyday listening program as well an ASC program.

You will be asked to listen to sentences in quiet and in noise and repeat the sentences. You will be seated in a comfortable chair inside the sound booth with 8 loudspeakers placed in a circular pattern around your head. We will test your sentence recognition abilities in your listening program as well as in the new listening program. The sentences and noise will be presented through loudspeakers at levels typically encountered in everyday communication environments. Your participation would involve approximately 20 minutes of testing plus 10 minutes to add the new listening program to their processor.

Eligibility criteria: Inclusion Criteria: Children with bilateral sensorineural hearing loss who have 1) one or two Nucleus 24 series cochlear implants, 2) at least 1 year experience with their cochlear implant, and, 3) the ability to score \> 50% correct for HINT sentences in quiet.

Exclusion Criteria: 1) Patients under 4 years of age or over 17 years of age, 2) patients who have had at least 1 year experience with their cochlear implant and, 3) patients who score \> 50% for HINT sentence recognition in quiet

Primary outcomes:
measure: The Objective is to examine speech perception performance in the presence of restaurant noise for pediatric cochlear implant recipients in two listening conditions: ADRO alone & ASC + ADRO.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Cynthia A Hargenrader, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05667038: Effect of Probiotics Among Overweight and Obese Saudi Adults
Official title: Effect of Multi-Strain Probiotics as an Anti-Obesity Among Overweight and Obese Saudi Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Obesity
Adult
Lead sponsor: King Saud University
Sponsor class: OTHER
First posted: 2022-12-28
Enrollment: 90
Sex: ALL
Minimum age (years): 19
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study is a 12-week, a single center, double-blind, placebo-controlled, randomized, trial, 90 overweight or first-class obese subjects will be divided equally into two groups, a probiotics group, and a placebo group.
Primary purpose: TREATMENT

Brief summary: Obesity is classified as a low-grade chronic and systemic inflammatory disease and results from complicated interactions between genes and environmental factors, which leads to many diseases and affects the quality of life. There are growing interests in the effectiveness of probiotics as a supplementation to treat obesity through regulating microbiota host metabolism. Probiotics may influence the interplays among gut, brain, adipose, and liver in a way leading to weight. Since limited studies have been conducted on human subjects, more investigation is needed in this field. Therefore, this study sheds light on the investigation of the anti-obesity effect of probiotic supplementation.

Detailed description: This study expects that the multi-strain probiotic product will induce beneficial changes in gut microbiota including reduction in weight, especially the visceral fat, which leads to reduction in systemic inflammatory state associated with fat accumulation. In order to evaluate the changes, ninety adult Saudi overweight or obese adult will be enrolled in this clinical trial and randomized to receive daily placebo or probiotics "MCP® BCMC® strains" for 12 weeks in a double-blind study. Biochemical markers will be measured through blood samples analyzed. Measurements and samples will be obtained at baseline and by the end of the study, at 12 weeks of treatment.

Eligibility criteria: Inclusion Criteria:

1. Adult's male and female ages between 19 to 40 years.
2. BMI (in kg/m2) from 25 to 35, (WHO, n. d.) Waist Circumference (WC) \> 88 cm (women) or \> 102 cm (men) (lean et al, 1995).
3. Stable body weight in the previous month of the trial.

Exclusion Criteria:

* Participants who suffer from diseases and on treatment, such as immune system diseases or thyroid disorders.
* Pregnant women or who plans to be pregnant.
* Participants who had gastrointestinal surgery.
* Hormone replacement therapy.
* Participants who taking antibiotic.
* Participants who consume probiotic or prebiotic supplementation regularly.

Primary outcomes:
measure: waist circumference
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: King Saud University
Study officials:
affiliation: King Saud University
name: Hanan A Alfawaz, Prof
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05764538: DAOIB for the Treatment of Brain Fog
Official title: DAOIB for the Treatment of Cognitive Impairment Induced by COVID-19 -An Open Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Long COVID
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2023-03-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a 24-week open trial. We will enroll long-COVID patients with cognitive impairments. All patients will receive DAOIB for 24 weeks. We will assess the patients every 8 weeks during the treatment period (weeks 0, 8, 16, and 24). We hypothesize that DAOIB treatment will be beneficial in improving the cognitive function, mood symptoms, global functioning and quality of life in long-COVID patients with cognitive impairments.


Eligibility criteria: Inclusion Criteria:

* "post-COVID-19 condition" defined by WHO (symptoms present at three months after SARS-CoV-2 infection and last for at least 2 months which cannot be explained by an alternative diagnosis)(Cabrera Martimbianco, Pacheco et al. 2021) and COVID-induced cognitive impairments
* physically healthy and have all laboratory assessments (including urine/blood routine, biochemical tests, and electrocardiograph) within normal limits
* have sufficient education to communicate effectively and are capable of completing the assessments of the study

Exclusion Criteria:

* history of significant cerebrovascular disease
* Hachinski Ischemic Score \> 4
* major neurological, psychiatric or medical conditions other than long COVID-induced cognitive impairments
* memantine use (memantine is an NMDAR partial antagonist)
* substance (including alcohol) abuse or dependence
* delusion, hallucination or delirium symptoms
* severe visual or hearing loss
* inability to follow the protocol

Primary outcomes:
measure: Change from baseline in the Alzheimer's disease assessment scale - cognitive subscale at week 8, 16 and 24
timeFrame: week 0, 8, 16, 24
Secondary outcomes:
measure: Change from baseline in Clinician's Interview-Based Impression of Change plus Caregiver Input score at week 8, 16 and 24
timeFrame: week 8, 16, 24
measure: Change from baseline in Alzheimer's disease Cooperative Study scale for ADL in MCI (ADCS-MCI-ADL) score at week 8, 16 and 24
timeFrame: week 0, 8, 16, 24
measure: Change from baseline in Quality of life score at week 8, 16 and 24
timeFrame: week 0, 8, 16, 24
measure: Change from baseline of 17-item Hamilton Rating Scale for Depression
timeFrame: week 0, 8, 16, 24
measure: Change from baseline of Hamilton Anxiety Rating Scale
timeFrame: week 0, 8, 16, 24
measure: Change from baseline of Perceived Stress Scale
timeFrame: week 0, 8, 16, 24
measure: Change from baseline in the score of a battery of additional cognitive tests
timeFrame: week 0, 8, 16, 24
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
Study officials:
References:
Clinical trial NCT06625138: Trial of Latex Vs Non-latex Hemorrhoid Banding
Official title: Single-blinded Randomized Trial of Latex Vs Non-latex Hemorrhoid Banding
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hemorrhoid
Hemorrhoid Bleeding
Keywords: hemorrhoid
banding
Lead sponsor: Huntington Memorial Hospital
Sponsor class: OTHER
First posted: 2024-10-03
Enrollment: 164
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: This study will involve the recruitment of adult patients with hemorrhoids for whom rubber band ligation is the recommended treatment. Patients will be randomized to receive banding with a latex band or non-latex band. Our goal will be to measure the performance of latex bands vs non-latex bands.

Detailed description: This study will involve the recruitment of adult patients with symptomatic grade 2-3 internal hemorrhoids for whom rubber band ligation is the recommended treatment. Patients will be randomized to receive banding with a latex band or non-latex band. Our hypothesis is that non-latex hemorrhoidal bands are non-inferior to latex bands for the treatment of grade 2-3 internal hemorrhoids.

The secondary objective of the study is to compare banding-related adverse effects including pain, bleeding, and complications assessed both immediately and within 3 weeks following each hemorrhoidal banding.

Eligibility criteria: Inclusion Criteria:

* Symptomatic grade 2-3 internal hemorrhoids undergoing rubber band ligation

Exclusion Criteria:

* Previous hemorrhoidal banding within the past year
* Known latex allergy
* Pregnancy
* Anticoagulation use
* Bleeding disorder
* Portal hypertension
* Inflammatory bowel disease
* Immunosuppression
* Functional neurologic disorder
* Pelvic floor dysfunction
* Any records flagged "break the glass" or "research opt out".

Primary outcomes:
measure: Hemorrhoid Band Efficacy
timeFrame: 2-4 months
Secondary outcomes:
measure: Banding-related Adverse events
timeFrame: 2-4 months
Other outcomes:
Locations:
city: Pasadena
country: United States
facility: Huntington Memorial Hospital
state: California
Study officials:
affiliation: Huntington Health
name: Adam Truong, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01308138: Myocardial Physiology And Microanatomy In Individuals Undergoing Heart Surgery
Official title: Study of Gaining Further Understanding of the Underlying Mechanisms of Myocardial Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Injury
Keywords: Physical Activity
pathology
Physical Deconditioning
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
First posted: 2011-03-03
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The main focus of the project is to determine to what degree myocardial energy metabolism is linked to impaired function in human cardiomyocytes, whether exercise training and remote ischemic preconditioning can restore cardiomyocyte function and whether this is linked to improved mitochondrial and cell function.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing coronary heart surgery and heart transplantation

Exclusion Criteria:

* myocardial infarction closer than 4 weeks to project start, serious valve defects, diabetes, unstable angina, uncontrolled hypertension, kidney failure (creatinin \> 140)

Primary outcomes:
measure: Mitochondrial respiration
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Norwegian University of Science and Technology, Medical Faculty
state: Sør-Trondelag
Study officials:
affiliation: National Taiwan Normal University
name: Katrine Hordnes, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Slagsvold KH, Moreira JB, Rognmo O, Hoydal M, Bye A, Wisloff U, Wahba A. Remote ischemic preconditioning preserves mitochondrial function and activates pro-survival protein kinase Akt in the left ventricle during cardiac surgery: a randomized trial. Int J Cardiol. 2014 Dec 15;177(2):409-17. doi: 10.1016/j.ijcard.2014.09.206. Epub 2014 Oct 14.
citation: Slagsvold KH, Rognmo O, Hoydal M, Wisloff U, Wahba A. Remote ischemic preconditioning preserves mitochondrial function and influences myocardial microRNA expression in atrial myocardium during coronary bypass surgery. Circ Res. 2014 Feb 28;114(5):851-9. doi: 10.1161/CIRCRESAHA.114.302751. Epub 2013 Dec 26.
Clinical trial NCT06209138: 5-fluorouracil for Treatment of Stable Vitiligo
Official title: Tailoring of HPMC-Zein Based Film Forming Gel of 5-fluorouracil for Treat-ment of Stable Vitiligo: a Strategy Assisted by Carbon Dioxide Laser Dermabra-sion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitiligo
Keywords: 5FU
Film forming gel
vitiligo
JAK3 gene expression
Dermabrasion
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2024-01-17
Enrollment: 40
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Vitiligo, a significant dermatologic challenge affecting 0.5 to 2% of the global population. Despite various existing medical approaches, current vitiligo treatments are still far from optimal.

Detailed description: Vtiligo, a significant dermatologic challenge affecting 0.5 to 2% of the global population. Despite various existing medical approaches, current vitiligo treatments are still far from optimal. 5FU is a well-known chemotherapeutic agent that has been used for colorectal cancer treatment. The drug prevents DNA synthesis by inhibiting the thymidylate synthetase. The hyperpigmenta-tion of the skin is the most side effect observed with 5-FU therapy which directed its use in treat-ment of vitiligo. Besides, many studies reported that 5-FU could induce regimentation in vitiligo by direct stimulation of melanocytes and increasing melanosomes numbers in the keratinocytes.

Eligibility criteria: Inclusion Criteria:

* Patients with stable vitlligo

Exclusion Criteria:

* patients under the age of 10 years.
* Individuals with a history of the Koebner phenomenon, a tendency for keloid or hypertrophic scarring
* Pregnancy.
* Recent isotretinoin therapy within the last 6 months.

Primary outcomes:
measure: Guartile grading scale
timeFrame: 2 months
measure: analysis of Jak3 expression in vitiligo lesions
timeFrame: 2months
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Al-Azhar University
state: No State
Study officials:
References:
Clinical trial NCT01184638: Long-term Outcome of General Anesthesia on Dysgnosia
Official title: Long-term Outcome Followed-up of the Cognitive Disorders After General Anesthesia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Delirium,
Dementia,
Amnestic,
Cognitive Disorders
Keywords: Cognitive Disorders
General anesthesia
Sevoflurane
Propofol
Memory
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
First posted: 2010-08-19
Enrollment: 10000
Sex: ALL
Minimum age (years): 10
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cognitive disorders in patients underwent general anesthesia are discussed for decades, but whether there were precise relationship between general anesthesia and dysgnosia is yet to be guaranteed. Although controversial data reported from experimental studies in animals, the investigators still proposed that general anesthetics could impair the normally organized system of the central nervous system, which finally displayed a dysfunction of cognition after general anesthesia in a short- or long-term period. Therefore, different types of general anesthetics such as inhalational anesthetics and intravenous anesthetics, the investigators hypothesized, had a long-term influence on patients' cognitive ability.


Eligibility criteria: Inclusion Criteria:

* Patients with informed consents
* Without basal disorders of neurology and psychiatrics

Exclusion Criteria:

* With the history of cognitive disorders
* With chronic neurological disorders
* Cannot communicate with investigators
* Cannot stand general anesthesia

Primary outcomes:
measure: Cognitive ability
timeFrame: The 10th year since postoperation
Secondary outcomes:
measure: Cognitive ability
timeFrame: One hour before operation
measure: Cognitive ability
timeFrame: Immediately after operation (0 day)
measure: Cognitive ability
timeFrame: One month after operation
measure: Cognitive ability
timeFrame: Six month after operation
measure: Cognitive ability
timeFrame: One year after operation
measure: Cognitive ability
timeFrame: Once a year from the 1st year after operation up to 9th year
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Maternity and Child Health Care Hospital
state: Jiangsu
Study officials:
affiliation: Nanjing Medical University
name: FuZhou Wang, PhD MD
role: STUDY_DIRECTOR
References: