louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03880643: Rituximab in Refractory Primary Membranous Nephropathy
Official title: Efficacy and Safety of Rituximab in Patients With Refractory Primary Membranous Nephropathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glomerulonephritis, Membranous
Keywords: membranous nephropathy
rituximab
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2019-03-19
Enrollment: 36
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 with primary membranous nephropathy who were treated using rituximab following resistance to at least one set of prior therapies including corticosteroids, alkylating agents or calcineurin inhibitors.

Brief summary: Primary membranous nephropathy (PMN), an autoimmune disease mostly associated with anti-phospholipase-A2-receptor (PLA2R) antibodies, is one of the most common causes of nephrotic syndrome in adults. In 30% to 40% of all cases, patients with PMN undergo spontaneous remission with conservative approaches. Corticosteroids, alkylating agents and calcineurin inhibitors are recommended treatment options in persistent disease activity despite supportive therapies. Nevertheless, patients with refractory disease constitute an important clinical aspect of PMN, and uncontrolled proteinuria may culminate in rapid progression to end-stage renal disease. In recent years, several studies demonstrated the efficacy of rituximab as a treatment option in patients with refractory PMN; however, data regarding daily clinical practice of this agent is still needed. Therefore, we conducted a study using our registry data to evaluate the efficacy and safety of rituximab in patients with refractory PMN.


Eligibility criteria: Inclusion Criteria:

* Having biopsy-proven primary membranous nephropathy.
* Showing resistance to at least one set of prior therapies including corticosteroids, alkylating agents or calcineurin inhibitors.
* Having a history of rituximab use (375 mg/m2/wk for 2-4 weeks) following resistance aforementioned agents.

Exclusion Criteria:

* Not providing or withdrawing consent.

Primary outcomes:
measure: Complete Remission
timeFrame: 6 months
measure: Partial Remission
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University
Study officials:
affiliation: Department of Internal Medicine, Istanbul Faculty of Medicine
name: Halil Yazici, MD
role: STUDY_CHAIR
affiliation: Department of Internal Medicine, Istanbul Faculty of Medicine
name: Safak Mirioglu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dahan K, Debiec H, Plaisier E, Cachanado M, Rousseau A, Wakselman L, Michel PA, Mihout F, Dussol B, Matignon M, Mousson C, Simon T, Ronco P; GEMRITUX Study Group. Rituximab for Severe Membranous Nephropathy: A 6-Month Trial with Extended Follow-Up. J Am Soc Nephrol. 2017 Jan;28(1):348-358. doi: 10.1681/ASN.2016040449. Epub 2016 Jun 27.
Clinical trial NCT06511843: Music for Pain in the Waiting Room
Official title: Examining Brief, Music Interventions for Acute Pain in the X-Ray Waiting Room
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Acute
Lead sponsor: Florida State University
Sponsor class: OTHER
First posted: 2024-07-22
Enrollment: 225
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 is a single-site, three-arm, parallel-group randomized clinical trial (RCT). The clinical effects of two, 4-minute, audio-recorded, music interventions (one with lyrics and the other without) for orthopedic patients will be investigated relative to a 4-minute audio-recoding about pain psychoeducation.


Eligibility criteria: Inclusion Criteria:

* Age ≥18
* Seeking treatment at the Tallahassee Orthopedic Center

Exclusion Criteria:

* Cognitive impairment preventing completion of study procedures.
* Other unstable illness judged by research staff to interfere with study involvement.

Primary outcomes:
measure: Change in Pain Unpleasantness Numeric Rating Scale
timeFrame: Immediately before to after 4-minute audio recording
Secondary outcomes:
measure: Change in Pain Intensity Numeric Rating Scale
timeFrame: Immediately before to after 4-minute audio recording
measure: Change in Anxiety Numeric Rating Scale
timeFrame: Immediately before to after 4-minute audio recording
Other outcomes:
measure: Change in Self-Transcendent State
timeFrame: Immediately before to after 4-minute audio recording
measure: Experience of Emotional Chills
timeFrame: Immediately after 4-minute audio recording
Locations:
city: Tallahassee
country: United States
facility: Tallahassee Orthopedic Clinic (TOC)
state: Florida
Study officials:
References:
Clinical trial NCT06671743: Premedication on Post-endodontic Pain
Official title: Effect of Premedication on Post-endodontic Pain in Patients With Symptomatic Irreversible Pulpitis, a Triple-blinded Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Premedication
Lead sponsor: Gulf Medical University
Sponsor class: OTHER
First posted: 2024-11-04
Enrollment: 48
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to compare the efficacy of preoperative administration of alpha-chemo-trypsin, ibuprofen, and acetaminophen in managing post-endodontic pain in patients with symptomatic irreversible pulpitis. The main question it aims to answer is:

What is the efficacy of preoperative administration of alpha-chemo-trypsin, ibuprofen, and acetaminophen in managing post-endodontic pain in patients with symptomatic irreversible pulpitis? Participants will undergo root canal treatment after premedication. Researchers will compare \[alpha-chemo-trypsin, ibuprofen, and acetaminophen\] to see the intensity of post-endodontic pain.


Eligibility criteria: Inclusion Criteria:

* Eligibility for root canal treatment Patients diagnosed with symptomatic irreversible pulpitis with normal apical tissue in mandibular molars

Exclusion Criteria:

* • Patient under any medication or analgesic intake for pain management.

  * Patients with any systemic health issues
  * Patient allergies to trypsin-chymotrypsin, ibuprofen, and paracetamol
  * Pregnancy.
  * Non-restorable teeth.
  * Immature roots.
  * Calcifications.
  * Resorptions.

Primary outcomes:
measure: Post-endodontic pain score
timeFrame: 6 hours
measure: Post-endodontic pain score
timeFrame: 12 hours
measure: Post-endodontic pain score
timeFrame: 24 hours
measure: Post-endodontic pain score
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Ajman
country: United Arab Emirates
facility: Gulf Medical University
Study officials:
References:
Clinical trial NCT00005343: Social Support and CHD Risk Factors--A Community Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Heart Diseases
Coronary Disease
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2000-05-26
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To examine the mechanism through which social support affects morbidity and mortality from coronary heart disease.

Detailed description: BACKGROUND:

Two hypotheses have been proposed to account for the effects of social support on cardiovascular morbidity and mortality. Both hypotheses operate through effects on risk factors for coronary heart disease, specifically arterial blood pressure and serum lipids. The stress- buffering hypothesis states that social support functions as a social resource for individuals exposed to social stressors; those persons with more support are less vulnerable to the risk-enhancing effects of stressors. The health behavior hypothesis states that persons with more support engage in more positive health behaviors, such as avoiding tobacco; moderate alcohol use; exercise; and, a prudent diet. A major limitation in research to evaluate these alternative hypotheses has been the failure to conceptualize and measure social support in a way appropriate to detect its effects in varying social and cultural contexts. This is a major issue in research in sub-cultural communities that are also high risk communities, such as African-Americans.

DESIGN NARRATIVE:

A cross-sectional survey of social stressors, social supports, health behaviors, and arterial blood pressure and serum lipids was conducted in a Black community in the rural South to evaluate the relative strengths of the stress-buffering versus the health behavior hypothesis. Social support was measured using a culturally appropriate technique which was sensitive both to the distinction between kin and nonkin social support, and the modification of the effects of that support by generational status. Multiple regression analysis and path analysis were used to evaluate the alternative hypotheses.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Dressler WW. Social identity and arterial blood pressure in the African-American community. Ethn Dis. 1996 Winter-Spring;6(1-2):176-89.
citation: Dressler WW. Hypertension in the African American community: social, cultural, and psychological factors. Semin Nephrol. 1996 Mar;16(2):71-82.
citation: Dressler WW. Social status and the health of families: a model. Soc Sci Med. 1994 Dec;39(12):1605-13. doi: 10.1016/0277-9536(94)90074-4.
Clinical trial NCT00674843: The Efficacy of Using Far Infrared Radiation to Manage Muscular Dystrophies
Official title: Phase 1 Study to Determine the Efficacy of Using Far Infrared Radiation to Manage or Treat Muscular Dystrophies.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Muscular Dystrophies
Keywords: MYOTONIC DYSTROPHY
MYOPATHIES
Distal Myopathies
Muscular Dystrophy, Duchenne
Phosphorylase Deficiency (McArdle Disease)
Lead sponsor: GAAD Medical Research Institute Inc.
Sponsor class: OTHER
First posted: 2008-05-08
Enrollment: 4
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The muscular dystrophies (MD) are a group of more than 30 neuromuscular disorders that are characterized by progressive skeletal muscle weakness, defects in muscle proteins and the death of muscle cells and tissue. This study will investigate the use of far infrared radiation for managing muscular dystrophies.

Detailed description: Observations from our research studies indicate that, far infrared rays provide energy to the body, improve the autonomic functions of the nervous system, restore the functions of the endocrine system, strengthen the immune system, improve blood circulation and increase the level of oxygen in the cells and promote the regeneration of muscle cells, nerves and brain cells.

It is hereby postulated that irradiation using far infrared, with wavelength between 5 to 20 microns, of the central nervous system, the endocrine system and the whole body could prevent, control, manage or possibly cure these neuromuscular disorders.

Eligibility criteria: Inclusion Criteria:

* Persons with muscular dystrophies

Exclusion Criteria:

* None

Primary outcomes:
measure: Management and Cure of muscular dystrophies
timeFrame: 2 Years
Secondary outcomes:
measure: Rehabilitation of people with muscular dystrophies
timeFrame: 2 Years
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Centre for Incurable Diseases
state: Ontario
Study officials:
affiliation: GAAD Medical Research Institute Inc.
name: Ken Nedd, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01937143: A Hospital-based Postnatal Parent Education Intervention About Infant Immunizations
Official title: Immunizing Infants Against Pain: a Hospital-based Postnatal Parent Education Intervention About Infant Immunizations
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Postpartum Women
Keywords: parent education
immunization
vaccination
infant
pain management
Lead sponsor: University of Toronto
Sponsor class: OTHER
First posted: 2013-09-09
Enrollment: 3420
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Immunization injections are the most common recurring painful medical procedure undertaken in childhood. Numerous evidence-based and feasible interventions are available to mitigate immunization pain, however, there is low uptake of these interventions in clinical practice, revealing a knowledge-to-care gap between what is known about pain and pain management. This is a 4-year single-centre, randomized, parallel 3-group add-on trial that will enrol 3420 mothers hospitalized following the birth of an infant at Mount Sinai Hospital (MSH) in Toronto. The trial will evaluate and compare the impact of two levels of intensity of maternal education about pain management during infant immunizations ('low': pamphlet vs. 'high': pamphlet + video) compared to placebo control after the birth of an infant on maternal behaviour during future infant immunizations at up to 6 months of age (use of analgesic interventions), maternal knowledge and attitudes about pain and pain management up to 6 months after birth.


Eligibility criteria: Inclusion Criteria:

* mothers rooming in with infants on postnatal ward

Exclusion Criteria:

* mothers with significant psychiatric conditions
* mothers unable to communicate in English
* mothers sharing room whereby another mother already participated

Primary outcomes:
measure: Analgesic utilization
timeFrame: Up to 6 months
Secondary outcomes:
measure: Knowledge
timeFrame: Up to 6 months
measure: Attitudes
timeFrame: Up to 6 months
measure: Specific analgesic utilization
timeFrame: Up to 6 months
measure: Immunization compliance
timeFrame: Up to 6 months
Other outcomes:
measure: Attempted analgesic utilization
timeFrame: Up to 6 months
Locations:
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
Study officials:
affiliation: University of Toronto
name: Anna Taddio, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Taddio A, Shah V, Bucci L, MacDonald NE, Wong H, Stephens D. Effectiveness of a hospital-based postnatal parent education intervention about pain management during infant vaccination: a randomized controlled trial. CMAJ. 2018 Oct 22;190(42):E1245-E1252. doi: 10.1503/cmaj.180175.
Clinical trial NCT05620043: Gene Expression Study Between Two Dermal Injectables Hydroxylapatite Semi-permanent Filler
Official title: A Randomized, Single-center, Prospective Biopsy Study Comparing a Poly L-lactic Acid Biostimulator and a Calcium Hydroxylapatite Semi-permanent Filler
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gene Expression
Lead sponsor: Galderma R&D
Sponsor class: INDUSTRY
First posted: 2022-11-17
Enrollment: 21
Sex: ALL
Minimum age (years): 22
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, single-center, comparative study
Primary purpose: TREATMENT

Brief summary: To compare gene expression stimulated by a semi-permanent filler and a biostimulator via punch biopsy

Detailed description: This is a randomized, single-center, comparative study to evaluate gene expression after treatment with a semi-permanent filler or a biostimulator.

This study is designed to enroll and randomize approximately 20 subjects in a 1:1 ratio of treatment to PLLA or CaHA. All randomized subjects are to have contour deficiency at the nasolabial folds.

Eligible subjects randomized to receive punch biopsy followed by treatment injection by the Treating Investigator at baseline. The method of injection was at the discretion of the Treating Investigator. A sufficient amount of product is injected to achieve optimal correction of the nasolabial folds, in the opinion of the Treating Investigator. PLLA group receives a second treatment at week 4 while CaHA group receives an optional touch-up if needed.

All subjects have final follow-up visit for a second punch biopsy on the other side of the nasolabial fold.

Eligibility criteria: Inclusion Criteria:

* Subject with a minimum of shallow nasolabial fold (NLF) contour deficiencies as assessed via the wrinkle assessment scale
* Subject with identical WAS scores on both NLFs
* Ability of giving consent for participation in the study
* Agreement to have skin biopsies on NLFs

Exclusion Criteria:

* Significant NLF asymmetry, or different WAS score on each NLF
* Pregnant, planning pregnancy during the course of the study or breastfeeding
* History of allergy or hypersensitivity to any ingredient of the treatment products
* History of allergy or hypersensitivity to anesthetics or lidocaine

Primary outcomes:
measure: Analyze gene expression via punch biopsy
timeFrame: 12 weeks after baseline
Secondary outcomes:
measure: Evaluate volume change in the treated area using 3D imaging
timeFrame: 4 and 12 weeks after baseline
Other outcomes:
Locations:
city: Miami
country: United States
facility: Miami Dermatology & Laser Institute
state: Florida
Study officials:
affiliation: Miami Dermatology & Laser Institute
name: Jill S Waibel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06303843: The Effect of Electric Ride-On Cars Use During Transport to the Operating Theatre
Official title: The Effect of Electric Ride-On Cars Use During Transport to the Operating Theatre on Preoperative Anxiety in Children Undergoing Elective Ambulatory Surgery: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Preoperative Anxiety
Pediatric Surgery
Lead sponsor: Uşak University
Sponsor class: OTHER
First posted: 2024-03-12
Enrollment: 118
Sex: ALL
Minimum age (years): 2
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of our study was to evaluate the effect of the use of a electric ride-on car during transport to the operating theatre on preoperative anxiety in children undergoing elective ambulatory surgery. As a distraction method, children in the experimental group will be introduced to the operating theatre with a electric ride-on car. Yale Modified Preoperative Anxiety Scale Child Form will be used to evaluate anxiety. The sample size was determined as 118 as a result of power analysis. 59 children will be included in the experimental group and 59 children in the control group.

Translated with DeepL.com (free version)


Eligibility criteria: Inclusion Criteria:

* Being between 2-10 years old,
* Less than 35 kg (according to the manufacturer's instructions for ride-on battery cars),
* To undergo elective surgery,
* Volunteering to participate in the study.

Exclusion Criteria:

* having cognitive or physical disabilities that may prevent riding a electric ride-on car
* premedication before surgery

Primary outcomes:
measure: Perioperative anxiety
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Usak
country: Turkey
facility: Usak University Training and Research Hospital
Study officials:
References:
Clinical trial NCT00180843: Assessment of Ventilation-perfusion Abnormalities in Patients With Stable Smoking-related Airways Disease
Official title: Assessment of Ventilation-perfusion Abnormalities in Patients With Smoking-related Airways Disease in Stable Condition and the Effect of Bronchodilator Therapy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2005-09-16
Enrollment: 2
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Subjects undergo history, examination, lung function assessment after informed consent has been obtained. All subjects will undergo ventilation-perfusion scans. If there first scan is normal they will undergo a second and final scan four weeks later. If abnormal they will undergo two further scans with either nebulized bronchodilator or nebulized saline prior to their second and third scans. Each time they will have repeat lung function tests prior to scanning. We will examine the regional changes in ventilation and perfusion and there relationship to lung function.

Detailed description: As in Brief description

Eligibility criteria: Inclusion Criteria:

* FEV1 \< 70% predicted at baseline on spirometry
* significant smoking history or alpha 1 antitrypsin deficiency
* no evidence of current infection or restrictive lung disease

Exclusion Criteria:

* history of other significant respiratory disease
* significant respiratory infection within 6 weeks
* history of significant physical or mental illness rendering them unfit for the study in the opinion of the investigator
* taken part in any other research within the past 12 months, or received exposure to ionizing radiation

Primary outcomes:
measure: scan grade
timeFrame: post scan
Secondary outcomes:
measure: lung function
timeFrame: pre scan
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Imperial College Hammersmith Campus
Study officials:
affiliation: Imperial College Hammersmith
name: Philip W Ind, MB BChir MRCP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03966443: Fluciclovine PET/CT in Multiple Myeloma Patients
Official title: PET i Diagnostikk og Behandlingsrespons av Pasienter Med Myelomatose
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Myeloma, Multiple
PET-CT
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2019-05-29
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Multiple myeloma patients

Brief summary: Comparison between image findings at aminoacid PET/CT and FDG PET/CT for myeloma patients


Eligibility criteria: Inclusion Criteria:

* Multiple myeloma patients suitable for ASCT treatment

Exclusion Criteria:

* Patients with contraindications to ASCT treatment

Primary outcomes:
measure: Comparing of image findings at PET
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hosptal
Study officials:
References: