louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02303002: Efficacy and Safety of Botulinum Toxin Type A for Injection to Treat Glabellar Lines
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Glabellar Frown Lines
Lead sponsor: Revance Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2014-11-27
Enrollment: 268
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a safety and efficacy study of botulinum toxin type A in subjects with glabellar frown lines.


Eligibility criteria: Inclusion Criteria:

* Moderate or severe glabellar frown lines
* Female or male, 30 to 65 years of age in good general health
* Women of childbearing potential must agree to use an effective method of birth control during the course of the study
* Willing to refrain from receipt of facial fillers, laser treatments or use of products that affect skin remodeling and causes an active dermal response

Exclusion Criteria:

* Any neurological condition that may place the subject at increased risk with exposure to Botulinum Toxin Type A such as amyotrophic lateral sclerosis and motor neuropathy, Lambert-Eaton syndrome, and myasthenia gravis
* Muscle weakness or paralysis, particularly in the treatment area
* Active skin disease or infections or irritation at the treatment area
* Facial asymmetry, deep dermal scarring, or inability to substantially lessen the glabellar frown lines by manually spreading them apart
* Treatment with Botulinum Toxin Type A in the face in the last 6 months or in the last 3 months anywhere in the body

Primary outcomes:
measure: Proportion of subjects assessed as responders by investigator assessment of severity of glabellar lines at maximum frown
timeFrame: Week 24
measure: Duration of response assessed by investigator assessment of severity of glabellar lines at maximum frown from the date of injection to when subject reverts to baseline severity
timeFrame: Up to Week 36
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
state: British Columbia
Study officials:
References:
citation: Bertucci V, Humphrey S, Carruthers J, Solish N, Muhn C, Swift A, Rubio RG, Shears G, Rosen N. Comparing Injectable DaxibotulinumtoxinA and OnabotulinumtoxinA in Moderate and Severe Glabellar Lines: Additional Analyses From a Phase 2, Randomized, Dose-Ranging, Double-Blind, Multicenter Study. Dermatol Surg. 2017 Dec;43 Suppl 3:S262-S273. doi: 10.1097/DSS.0000000000001364.
citation: Carruthers J, Solish N, Humphrey S, Rosen N, Muhn C, Bertucci V, Swift A, Metelitsa A, Rubio RG, Waugh J, Quiring J, Shears G, Carruthers A. Injectable DaxibotulinumtoxinA for the Treatment of Glabellar Lines: A Phase 2, Randomized, Dose-Ranging, Double-Blind, Multicenter Comparison With OnabotulinumtoxinA and Placebo. Dermatol Surg. 2017 Nov;43(11):1321-1331. doi: 10.1097/DSS.0000000000001206.
Clinical trial NCT04496102: Cemented vs Cementless in Bilateral TKA
Official title: Comparison of Efficacy Between Cemented and Cementless Total Knee Arthroplasty in Bilateral Total Knee Arthroplasty. A Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis
Total Knee Arthroplasty
Keywords: cemented
cementless
total knee arthroplasty
short term outcome
functional outcome
Lead sponsor: Thammasat University
Sponsor class: OTHER
First posted: 2020-08-03
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the functional outcomes between cemented and cementless TKA in bilateral knee replacement patient.

Detailed description: To compare early functional outcomes, radiographic finding and operative time between cemented and cementless modern implant in sequential bilateral total kee arthroplasty.

Eligibility criteria: Inclusion Criteria:

* ASA status 1 or 2
* Diagnosed with bilateral osteoarthritis of the knees
* Participant understand and consent to the protocol of the trial

Exclusion Criteria:

* Morbid obesity (BMI \>40)
* Inflammatory arthritis
* Osteoporosis
* Metabolic bone disease
* Bone defect that seen from radiographs

Primary outcomes:
measure: Compare mean Forgotten joint score between 2 groups
timeFrame: at 1 year
Secondary outcomes:
measure: Operative time
timeFrame: intra-operative assessment
measure: modified the Western Ontario and McMaster Universities Osteoarthritis Index score
timeFrame: post-op 2, 6 week, 3, 6, 12 month
measure: Pain level
timeFrame: Once daily 1-14 days after surgery then once a week until 3 months
measure: Range of knee motion
timeFrame: post-op 2, 6 week, 3, 6, 12 month
measure: complication
timeFrame: until 1 year after surgery
measure: Radiological finding
timeFrame: post-op 2, 6 week, 3, 6, 12 month
Other outcomes:
Locations:
city: Khlong Luang
country: Thailand
facility: Thammasat University
state: Pathum Thani
Study officials:
References:
Clinical trial NCT06277102: Effects of Music on Acute Postoperative Pain Intensity and Mobility After Fragility Hip Fracture
Official title: Effects of Music on Acute Postoperative Pain Intensity and Mobility After Fragility Hip Fracture: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hip Fractures
Keywords: pain control
music
fragility hip fracture
Lead sponsor: Hospital Authority, Hong Kong
Sponsor class: OTHER_GOV
First posted: 2024-02-26
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Music has been proven to be beneficial in postoperative care by reducing pain. The effects of music listening to reduce pain postoperatively are well studied among cases undergoing elective orthopaedic surgery. No study has been conducted focusing on pain control among cases with fragility hip fractures in an acute ward setting with non-schedule non-elective orthopaedic operation.

In Queen Elizabeth Hospital a standardized analgesic protocol is used for all fragility hip fracture cases unless contraindicated, a suboptimal post-operative pain control is not uncommonly seen. Stepping up analgesics is usually a concern in the elderly with a higher rate of side effects, a safe and simple non-pharmacological intervention for pain control is therefore needed.

The aim of this study is to study the effectiveness of incorporating music on pain intensity and mobility with the standard postoperative rehabilitation care of fragility hip fracture in Queen Elizabeth Hospital.


Eligibility criteria: Inclusion Criteria:

1. Emergency admitted to QEH/G9 due to fragility hip fracture (#NOF or # TOF) within the study period
2. Plan for surgical intervention
3. Able to provide written informed consent
4. Able to communicate in Cantonese/ Putonghua/ English

Exclusion Criteria:

1. History of dementia
2. Acute delirium upon admission
3. Disorientated to time, person or place
4. Concurrent fracture at other sites
5. Utilization of other analgesics on top of pain protocol
6. Appreciable deficits in hearing or vision
7. Hemodynamically unstable
8. Plan for neurolysis/ nerve block as definite treatment or opt for conservative treatment

Primary outcomes:
measure: Pain intensity measured by 11-point pain intensity numerical rating scale after music listening in postoperative Day 1 - 2 among subjects with fragility hip fracture
timeFrame: postoperative day 1 and 2
Secondary outcomes:
measure: Modified functional ambulatory classification (MFAC) in postoperative Day 3 among subjects with fragility hip fracture
timeFrame: postoperative day 3
measure: New mobility score (NMS) in postoperative Day 3 among subjects with fragility hip fracture
timeFrame: postoperative day 3
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: Ward G9, Queen Elizabeth Hospital
Study officials:
References:
Clinical trial NCT02921802: A Study of Special Use Results Surveillance of Revlimid 5mg Capsules
Official title: Revlimid 5 mg Capsules Special Use-results Surveillance (All-case Surveillance)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Myeloma
Myelodysplastic Syndromes
Keywords: Teratogenicity
Thrombocytopenia and haemorrhage
Neutropenia and infection
Venous thromboembolism
Allergic reactions
Diarrhoea or constipation
Peripheral neuropathy
Cardiac failure
Arrhythmia
Renal failure
Myocardial infarction
Interstitial lung disease
Tumour lysis syndrome
Transformation from myelodysplastic syndrome to acute myeloid leukemia
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2016-10-03
Enrollment: 4626
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Among relapsed or refractory multiple myeloma and Myelodysplastic syndrome (MDS) with a deletion 5q cytogenetic abnormality patients, all patients who received Pomalyst will be targeted in this surveillance.

Brief summary: To understand the safety and efficacy of Revlimid® 5 mg Capsules (hereinafter referred to as Revlimid) in all patients who are treated with it under the actual condition of use pursuant to the conditions of approval.

1. Planned registration period This period started on the date of initial marketing of Revlimid and will end at the time when the planned number of patients to be enrolled is reached.
2. Planned surveillance period This period started on the date of initial marketing of Revlimid and will end on the day when the approval condition related to all-case surveillance is terminated.


Eligibility criteria: Inclusion Criteria:

* Among relapsed or refractory multiple myeloma and Myelodysplastic syndrome (MDS) with a deletion 5q cytogenetic abnormality patients, all patients who received Revlimid will be targeted in this surveillance.

Exclusion Criteria:

N/A

Primary outcomes:
measure: Adverse Events (AEs)
timeFrame: Up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kobe
country: Japan
facility: Shinko Hospital
state: Hyogo
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT03236402: "A Study to Assess Knowledge and Opinion Regarding Adoption Among Adults Residing in Rural and Urban Area"
Official title: "A Cross-sectional Comparative Study to Assess Knowledge and Opinion Regarding Adoption Among Adults Residing in Rural and Urban Area of Ambala, Haryana"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Knowledge
Keywords: Knowledge
Opinion
Adoption
Adults
Cross-Sectional
Lead sponsor: Maharishi Markendeswar University (Deemed to be University)
Sponsor class: OTHER
First posted: 2017-08-01
Enrollment: 400
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population of the present study was Adults residing in rural and urban area of Haryana.

Target population:- Adults residing in rural areas and urban areas of Ambala District Haryana.

Accessible population:- Adults residing in rural area (Mullana) and urban area (muncipal corporator ward number 14 and ward number 15 of Mahesh Nagar) of Ambala District Haryana and available during data collection.

Brief summary: A cross - sectional comparative study to assess knowledge and opinion regarding adoption among adults residing in rural and urban area of Ambala, Haryana.

Detailed description: ABSTRACT INTRODUCTION: Children are regarded as the precious gift in world. It is estimated that between 8% and 12% of couples worldwide suffer from infertility with rate of 10% in India and about 20 million children are orphan even then adoption rates are falling in India.

OBJECTIVES: To assess and compare the knowledge score and opinion score regarding adoption among adults of different age groups.To determine relationship between knowledge and opinion regarding adoption among adults.To seek association of knowledge score and opinion score regarding adoption with selected variables.

METHODOLOGY: A descriptive cross sectional survey design was used. 400 adults of rural (200) and urban (200) area were selected by using quota sampling technique. The data was collected by structured knowledge questionnaire and structured likert scale.

Eligibility criteria: Inclusion Criteria:

* Adults who were able to understand Hindi and English.
* Who were willing to participate in the study.

Exclusion Criteria:

* Adults who were not available at the time of data collection.
* Adults having any psychological impairment.

Primary outcomes:
measure: Structured Questionnaire
timeFrame: 25-30 minutes
Secondary outcomes:
measure: Likert Scale
timeFrame: 18-20 minutes
Other outcomes:
Locations:
Study officials:
affiliation: Maharishi Markandeshwar University
name: Poonam Sheoran, Ph.D Nursing
role: STUDY_DIRECTOR
References:
citation: Ezugwu FO, Obi SN, Onah HE. The knowledge, attitude and practice of child adoption among infertile Nigerian women. J Obstet Gynaecol. 2002 Mar;22(2):211-6. doi: 10.1080/01443610120113463.
Clinical trial NCT00845702: Renal Magnetic Resonance Angiography (MRA) Study Comparing Dotarem and Time Of Flight (TOF)
Official title: Evaluation of Dotarem-enhanced Magnetic Resonance Angiography (MRA) Compared to Time-Of-Flight (TOF) MRA in the Diagnosis of Renal Arterial Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Renal Artery Stenosis
Keywords: Renal artery stenosis
Contrast agent
MRA
Lead sponsor: Guerbet
Sponsor class: INDUSTRY
First posted: 2009-02-18
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The study will evaluate the efficacy and safety of Dotarem enhanced MRA compared to TOF MRA in patients suffering from renal arterial disease.

Detailed description: Each participant will undergo first a TOF MRA followed by a Dotarem-enhanced MRA.

Eligibility criteria: Inclusion Criteria:

* Male or female, aged more than 18 years,
* Strongly suspected of having renal arterial disease,
* Scheduled (or to be scheduled) to undergo arterial catheter-based X-ray angiography examination,

Exclusion Criteria:

* Known grade IV or V chronic kidney disease (GFR\<30 mL/min/1.73m²),
* Contraindication to MRI,
* Acute renal dysfunction within the 6 months preceding Dotarem®-enhanced MRA examination,

Primary outcomes:
measure: Percent of Non Assessable Renal Artery Segments
timeFrame: 1 to 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Bloomington
country: United States
facility: Guerbet LLC
state: Indiana
Study officials:
References:
Clinical trial NCT01536002: Pharmacokinetics of Propofol in Morbidly Obese Patients
Official title: Pharmacokinetics (PK) of Propofol in Bariatric (Morbidly Obese) Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obesity, Morbid
Keywords: Bariatric surgery
Anesthetics, intravenous
Propofol
Pharmacokinetics
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2012-02-20
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The objectives of this study are

* To determine PK of propofol in bariatric patients
* To identify the physiological variables that induce propofol PK changes in bariatric patients, when compared to a normal-weight population.
* To define context-sensitive half-time profiles for propofol in bariatric patients.


Eligibility criteria: Inclusion Criteria:

* Consecutive patients admitted to the Aker University Hospital, scheduled for general or bariatric surgery,
* Both genders. Female subjects of childbearing potential must be using adequate contraception (i.e. using oral or IM contraception or an IUCD) and must have a negative pregnancy test (urine beta-HCG).
* Aged 18 - 60 years, both inclusive
* Body mass index (BMI) ≥ 20 kg/m2
* Written informed consent

Exclusion Criteria:

* Patients that are considered not to tolerate a standard dose of propofol administered as a bolus.
* Known hypersensitivity to propofol or its ingredients (soy, lecithin, glycerol, oil acid)
* Known hypersensitivity to any of the anesthetic agents to be used
* Pregnant women
* Lactating women

Primary outcomes:
measure: Propofol plasma concentrations
timeFrame: 0-24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital, Oslo, Norway
name: Tom Heier, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04853602: IFx-Hu2.0 Expanded Access Program
Official title: IFx-Hu2.0 Expanded Access Program
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Cutaneous Melanoma, Stage III
Cutaneous Melanoma, Stage IV
Merkel Cell Carcinoma
Cutaneous Squamous Cell Carcinoma
Keywords: CM
MCC
cSCC
pDNA
plasmid DNA
pAc/emm55
IFx-Hu.20
Immunotherapy
Gene Therapy
Immunology
Oncology
Immuno-Oncology
Lead sponsor: TuHURA Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2021-04-21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: Expanded access requests for IFx-Hu2.0 may be considered for the treatment of adult patients (greater than or equal to 18 years of age) with stage III through IV cutaneous melanoma, advanced Merkel cell carcinoma (MCC), or advanced cutaneous squamous cell carcinoma (cSCC) who have failed all available treatment options.

To request access, use Responsible Party contact information provided in this record..


Eligibility criteria: Inclusion Criteria:

* To request more information use Responsible Party contact information provided in this record

Exclusion Criteria:

* To request more information use Responsible Party contact information provided in this record

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Bunch BL, Kodumudi KN, Scott E, Morse J, Weber AM, Berglund AE, Pilon-Thomas S, Markowitz J. Anti-tumor efficacy of plasmid encoding emm55 in a murine melanoma model. Cancer Immunol Immunother. 2020 Dec;69(12):2465-2476. doi: 10.1007/s00262-020-02634-4. Epub 2020 Jun 18.
Clinical trial NCT03995121: SV2 PET Imaging with [11C]APP311
Official title: Synaptic Density in Psychiatric Disorders Using SV2A Receptor PET Imaging with [11C]APP311
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Schizophrenia and Other Psychotic Disorders
Cannabis Use Disorder
Healthy
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2019-06-21
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Recruiting Subjects with Schizophrenia and other Psychotic disorders Cannabis Use Disorder Healthy controls

Brief summary: The aim of this study is to evaluate a new SV2A tracer, \[11C\]APP311, in healthy aging and neuropsychiatric disorders including psychotic disorders and cannabis use disorders.

Detailed description: The overall goal of this protocol is to study synaptic density in two psychiatric disorders (namely schizophrenia and other psychotic disorders, and cannabis use disorder) with this exciting new PET tracer. Secondary outcomes will include electroencephalography (EEG). A battery of EEG paradigms assessing sensory, perceptual, and cognitive functions will also be administered. The primary dependent measures will be traditional event related potentials (ERPs; e.g. latency and amplitude) as well as time X frequency analysis (inter-trial coherence and spectral power).

Eligibility criteria: Inclusion Criteria:

* Willing and able to give voluntary written informed consent
* Male and Female subjects, age 18 to 65 years, inclusive

Exclusion Criteria:

* MRI metal exclusions and claustrophobia.
* Education completed is less than 12 years

Primary outcomes:
measure: Synaptic density in psychiatric disorders using SV2A receptor PET Imaging with [11C]APP311
timeFrame: One test day (one time point).
Secondary outcomes:
measure: Correlation of Synaptic density with cognition and EEG
timeFrame: One test day (one time point).
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Conneticut Mental Health Center
state: Connecticut
Study officials:
References:
Clinical trial NCT04400721: Efficacy of an Erector Spinae Plane Block in VATS/RATS
Official title: The Effects of Thoracic Nerve Blocks on Postoperative Pain, Respiratory Function and Recovery in Patients Undergoing Thoracoscopic Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Pain, Postoperative
Post-Op Complication
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2020-05-22
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-blinded, single-center, randomized, prospective study
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aims to study the analgesic and respiratory effects of the erector spinae plane block for patients undergoing video-assisted thoracic surgery (VATS) or robotic assisted thoracic surgery (RATS).

Detailed description: A total of 120 subjects will be randomized into three groups (30 per group). Arm A: IV PCIA Arm B: IV PCIA + ultrasound guided Erector spinae block (ESPB, Single shot of 30ml of 0.5% solution of Naropin \[Ropivacaine\]) Arm C: IV PCIA + multilevel intra-thoracic intercostal nerve block (ICB, Single shot of 30ml of 0.5% solution of Naropin \[Ropivacaine\]) PCIA pumps for all study cohorts will be programmed according to our institution's standard protocol (Dipidolor \[Piritramide\] bolus: 2mg, interval: 7 min, max 4h dose: 30mg). The erector spinae block will be placed preoperatively, the intercostal block will be placed at the beginning of the procedure. All patients will receive standard postoperative care. The patients will be blinded for the study arm.

The primary endpoint of this study is postoperative pain and will be recorded by using the numerical rating scale (NRS) pain score. Pain scores will be measured by the investigator at rest and during coughing. Opioid consumption will be monitored and registered for.

Eligibility criteria: Inclusion Criteria:

* Male and female patients
* age between 18 to 100 years old
* ASA 1-3
* scheduled for VATS
* informed consent explained and signed

Exclusion Criteria:

* Patients \< 18 years old, \> 100 years old
* ASA physical status \> 3
* previous cardiac surgery or ipsilateral thoracic surgery
* neuropsychiatric diseases
* allergy to analgesics or local anesthetics or other medications used in the study
* abuse of opioids or sedatives
* contraindication to receive regional anesthesia (e.g. coagulation defect)
* patients who could not understand the VAS pain-scoring system
* patient refusal to follow participation
* expected post operative mechanical ventilation
* intolerance or allergy to any prescribed medication

Primary outcomes:
measure: Efficacy of ESP block in decreasing postoperative pain intensity
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: