louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02328573: The Impact of Group Singing on Patients With Stroke and Their Personal Caregivers
Official title: The Impact of Group Singing on Patients With Stroke and Their Personal Caregivers
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Stroke and Aphasia
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2014-12-31
Enrollment: 80
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: The study will focus on the impact of communal singing on patients with stroke and their personal caregivers. Forty post-stroke patients will be randomly assigned to two groups: the first group of 20 stroke survivors and their caregivers (up to 40 total participants) will receive 6 months (approximately 24 sessions) of music therapy. The second control groups of 20 stroke survivors and their caregivers will receive standard post-stroke care

Detailed description: The study will focus on the impact of communal singing on patients with stroke and their personal caregivers. Forty post-stroke patients will be randomly assigned to two groups: the first group of 20 stroke survivors and their caregivers (up to 40 total participants) will receive 6 months (approximately 24 sessions) of music therapy. The second control groups of 20 stroke survivors and their caregivers will receive standard post-stroke care.

All enrolled participants will be assessed on their mood, past music experience and music genre preference (music therapy assessment). They will complete the abridged Beck (BDI-2-fastscreen) questionnaire, the stoke and aphasia quality of life scale; a Likert which measures distress; the Western Aphasia Battery (WAB); the NIH Stroke Scale (SS); the Figely compassion scale; and the driving scene test (Stern and White); and the Rankin. In additional we will take saliva samples from all participants to measure hormone levels.

Participants can attend zoom or live.

Eligibility criteria: Inclusion Criteria:

* Stroke victim, regardless of level of stroke

Exclusion Criteria:

* None

Primary outcomes:
measure: Change in mood and quality of life as indicated through saliva (cortisol and melatonin sampling)
timeFrame: 6 months
Secondary outcomes:
measure: Change in language aphasia outcome improvement
timeFrame: 6 months
Other outcomes:
measure: Change in motivation and verbal expression
timeFrame: 6
Locations:
city: New York
country: United States
facility: Mount Sinai Beth Israel
state: New York
Study officials:
affiliation: Beth Israel Medical Center
name: Joanne Loewy, DA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06063473: A Study Comparing Trifarotene Cream 0.005% to AKLIEF® Cream in the Treatment of Acne Vulgaris
Official title: A Multi-center, Double-blind, Randomized, Placebo Controlled, Parallel-group Study, Comparing Trifarotene Cream 0.005% (Taro Pharmaceuticals U.S.A, Inc.) and to AKLIEF® Cream (Trifarotene 0.005%,Galderma) and Both Active Treatments to a Placebo Control in the Treatment of Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acne Vulgaris
Lead sponsor: Taro Pharmaceuticals USA
Sponsor class: INDUSTRY
First posted: 2023-10-02
Enrollment: 762
Sex: ALL
Minimum age (years): 12
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To demonstrate therapeutic equivalence and safety of Trifarotene cream 0.005% (Taro Pharmaceuticals U.S.A., Inc.) and AKLIEF® cream in the treatment of acne vulgaris

Detailed description: A multi-center, double-blind, randomized, placebo-controlled, parallel-group study, comparing Trifarotene Cream 0.005% (Taro Pharmaceuticals U.S.A., Inc.) to AKLIEF® Cream and both active treatments to a placebo control in the treatment of acne vulgaris

Eligibility criteria: Inclusion Criteria:

* Healthy male or non-pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris.
* Subjects who are 18 years of age or older (up to the age of 40) must have provided IRB approved written informed consent. Subjects ages 12 to 17 years of age inclusive must have provided IRB approved written assent;
* Subjects must have a definite clinical diagnosis of acne vulgaris of severity grade 2, 3,or 4 as per the Investigator's Global Assessment (IGA)
* Subjects must have ≥ 25 non-inflammatory lesions (i.e., open and closed comedones) AND ≥ 20 inflammatory lesions (i.e., papules and pustules) AND ≤2 nodulocystic lesions (i.e., nodules and cysts), at baseline on the face.

Exclusion Criteria:

* Female Subjects who are pregnant, nursing or planning to become pregnant during study participation
* Subjects with a history of hypersensitivity or allergy to tretinoin, retinoids, or any of the study medication ingredients.
* Subjects with the presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris (e.g., on the face: rosacea, dermatitis, psoriasis,squamous cell carcinoma, eczema, acneiform eruptions caused by medications,steroid acne, steroid folliculitis, or bacterial folliculitis).

Primary outcomes:
measure: Demonstration in Therapeutic Equivalence & Safety of the Investigational Product
timeFrame: Baseline to Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Hawthorne
country: United States
facility: Taro Pharmaceuticals USA Inc.
state: New York
Study officials:
affiliation: Taro Pharmaceuticals, Inc.
name: Natalie Yantovskiy
role: STUDY_DIRECTOR
References:
Clinical trial NCT00697073: Study to Assess the Safety and Tolerability of Idebenone in the Treatment of Friedreich's Ataxia Patients
Official title: A Phase III Open-Label, Single Group Extension Study of the Safety and Tolerability of Idebenone in the Treatment of Friedreich's Ataxia Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Friedreich's Ataxia
Keywords: Friedreich's Ataxia
Idebenone
ICARS
Lead sponsor: Santhera Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2008-06-13
Enrollment: 68
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is meant to assess the safety and tolerability of idebenone in patients with Friedreich's Ataxia over a 12 months period.

Detailed description: The study involves 6 clinic visits.

Eligibility criteria: Inclusion criteria:

* Friedreich's ataxia patients completing core study SNT-III-002 (NCT00537680) and presenting at Week 24 (Visit 5) of that study
* Body weight ≥ 25kg/55 lbs
* Negative urine pregnancy test
* Patients who in the opinion of the investigator are able to comply with the requirements of this study

Exclusion criteria:

* Adverse events during the course of SNT-III-002(NCT00537680)which in the opinion of the investigator are attributable to idebenone and preclude further treatment with idebenone
* Clinically significant abnormalities of clinical hematology or biochemistry including, but not limited to, elevations greater than 2 times the upper limit of normal of AST, ALT or creatinine
* Treatment with coenzyme Q10, vitamin E (if taken at a dose 5 times above the daily requirement) or other sources of idebenone within the past month
* Parallel participation in another clinical drug trial
* Past or present history of abuse of drugs or alcohol
* Pregnancy or breast-feeding

Primary outcomes:
measure: Change in ICARS
timeFrame: baseline and 12 months
Secondary outcomes:
measure: FARS (Friedreich's Ataxia Rating Scale)
timeFrame: baseline and 12 Months
measure: Nature of Adverse Events
timeFrame: 12 Months
measure: Frequency/Number of Mild, Moderate, and Severe Adverse Events
timeFrame: 12 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: David Geffen School of Medicine, UCLA
state: California
city: Philadelphia
country: United States
facility: The Children's Hopsital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: University of California, Los Angeles
name: Susan Perlman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Children's Hospital of Philadelphia
name: David Lynch, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Meier T, Perlman SL, Rummey C, Coppard NJ, Lynch DR. Assessment of neurological efficacy of idebenone in pediatric patients with Friedreich's ataxia: data from a 6-month controlled study followed by a 12-month open-label extension study. J Neurol. 2012 Feb;259(2):284-91. doi: 10.1007/s00415-011-6174-y. Epub 2011 Jul 22.
Clinical trial NCT06423573: A Study to Assess the Incidence of Skin Cancers in Patients With Epidermolysis Bullosa Receiving Filsuvez
Official title: A Long-term Non-interventional Study to Assess the Incidence of Skin Malignancies in Patients With Dystrophic and Junctional Epidermolysis Bullosa Receiving Treatment With Filsuvez
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Epidermolysis Bullosa, Dystrophic
Epidermolysis Bullosa, Junctional
Keywords: Filsuvez
Birch bark extract
Lead sponsor: Amryt Pharma
Sponsor class: INDUSTRY
Collaborators: name: Chiesi Farmaceutici S.p.A.
First posted: 2024-05-21
Enrollment: 580
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with dystrophic EB or junctional EB, whether they are receiving Filsuvez, receiving another treatment for EB, or not receiving any treatment.

Brief summary: In patients with epidermolysis bullosa (EB), collagen does not form properly, so their skin is very fragile and blisters easily. Such patients are also at greatly increased risk of developing skin cancers. Filsuvez is a topical gel used to promote healing of skin lesions in patients with certain types of EB. In this observational study, patients with either dystrophic EB (DEB) or junctional EB (JEB) will receive standard of care treatment, whether Filsuvez or something else, and will be followed for up to 5 years. The main purpose is to see if the use of Filsuvez affects the likelihood of developing skin malignancies in these patient populations.

Detailed description: Some forms of EB are associated with a greatly increased incidence of aggressive skin and mucosal squamous cell carcinoma (SCC), as well as increased incidence of other skin malignancies including basal cell carcinoma (BCC) and malignant melanoma (MM). This long-term non-interventional study will assess all types of skin malignancies (SCC, BCC, and MM) in DEB and JEB patients. It is an observational study of real-world treatment practices, in which patients will receive standard of care therapy whatever that may entail. Data will be obtained from two sources: clinical study centers in the European Union (EU) and the United Kingdom (UK), and pre-existing EB registries in the EU. Participants will be followed for up to 5 years, and information about the development and nature of skin malignancies will be collected over this time period both from patients who are taking and those who are not taking Filsuvez.

Eligibility criteria: Inclusion Criteria:

* Patients with a confirmed diagnosis of dystrophic EB or junctional EB

Exclusion Criteria:

* None

Primary outcomes:
measure: Incidence of first skin malignancy during follow-up in EB patients receiving Filsuvez
timeFrame: Up to 5 years
Secondary outcomes:
measure: Incidence of first skin malignancy during follow-up in EB patients not receiving Filsuvez
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Toulouse
country: France
facility: CHU de Toulouse, Hôpital Larrey
Study officials:
References:
Clinical trial NCT02030873: The Effect of Virtual Simulation Training in Mastoidectomy
Official title: The Effect of Virtual Simulation Training With the Visible Ear Simulator on Mastoidectomy Performance of Otorhinolaryngology Trainees
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medical Education
User-Computer Interface
Clinical Skills
Motor Skills
Temporal Bone
Keywords: virtual simulation
temporal bone
surgical training
medical education
self-directed learning
final product assessment
cognitive load
reaction time
skills training
simulator metrics
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2014-01-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study is to investigate the effect of virtual simulation training on mastoidectomy dissection performance of otorhinolaryngology trainees, to explore performance assessment using a final-product analysis approach and to explore the role of cognitive load.

Detailed description: Traditional dissection training in temporal bone surgery is not evidence-based yet gold standard. In the recent years the Visible Ear Simulator has been used as an introduction to mastoidectomy in the Danish temporal bone course curriculum before letting the participants move on to dissection training in order to maximize the yield from the dissection training. Instructors have the impression that participants perform better in dissection after the simulator training session has been introduced. Our pilot study suggests that participants perform better in the simulator compared to traditional dissection training. This could be due to a reduction of the cognitive load in the virtual simulator.

These observations lead to the hypothesis that virtual simulation training of mastoidectomy provides an effect that improves performance in traditional dissection training.

Eligibility criteria: Inclusion Criteria:

* Resident in otorhinolaryngology postgraduate year 2-5
* Informed written consent

Exclusion Criteria:

* Previous participation in formal mastoidectomy training in a virtual simulator

Primary outcomes:
measure: Change in Final Product Assessment Score
timeFrame: 3 hours
Secondary outcomes:
measure: Change in simulator metrics
timeFrame: 3 hours
measure: Change in reaction time
timeFrame: 3 hours
measure: Simulation experience
timeFrame: At recruitment
measure: Demographics
timeFrame: At recruitment
measure: Computer skills
timeFrame: At recruitment
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Steven AW Andersen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04213573: Efficacy of Silver Diamine Fluoride and Its Parental Perception
Official title: Parental Perception of Silver Diamine Fluoride Staining and Its Efficacy on Caries Arrestment in Comparison to Sodium Fluoride With Casein Phosphopeptide-amorphous Calcium Phosphate
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE2
PHASE3
Conditions: Dental Caries in Children
Lead sponsor: University of Baghdad
Sponsor class: OTHER
First posted: 2019-12-30
Enrollment: 60
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized clinical trial aims to compare the effectiveness of two topical fluoride application protocols, namely 38% silver diamine fluoride and sodium fluoride with added casein phosphopeptide-amorphous calcium phosphate (CPP-ACP) in arresting dental caries in children.

Detailed description: The present randomized clinical study is aiming to evaluate the effectiveness of silver diamine fluoride (SDF) in arresting dentin caries lesions when compared to MI Varnish a 5% sodium fluoride varnish which also contains RECALDENT™\* (CPP-ACP): Casein Phosphopeptide-Amorphous Calcium Phosphate. For this, healthy children aged 4-8 years with at least one active dentin carious lesion will be allocated randomly to one of two treatment groups: Group (1) SDF and Group (2) MI Varnish. Each participant will be assigned to one treatment group to avoid the possible synergistic effect of the different agents.

Parents/ guardians of each child will be fully informed regarding the study design, objectives and probable advantages and side effects especially the black discoloration of SDF before their involvement by written consent. The International Caries Detection and Assessment System (ICDAS II) will be used to determine caries diagnosis and activity.visual and tactile examination will be done with a WHO probe to assess the primary outcome. the secondary outcome will be conducted by a questionnaire given to the parents.

Eligibility criteria: Inclusion Criteria:

1. Normal healthy children without any systemic disease ASA 1 physical status.
2. Children with at least one carious dentin lesion in their primary teeth, code 5 (ICDAS II)

Exclusion Criteria:

1. Children who suffer from major systemic diseases and require long term medications.
2. Children refuse the study intervention.
3. Children with silver or milk product sensitivity.
4. Presence of any gingival or perioral ulceration or stomatitis.
5. Tooth with abscess, fistula or severe pain.

Primary outcomes:
measure: caries arrestment
timeFrame: 2 weeks
Secondary outcomes:
measure: Parent perception
timeFrame: 0 - 2 weeks
Other outcomes:
Locations:
city: Baghdad
country: Iraq
facility: al-Ameriya dental specialized center
state: Al-karkh
Study officials:
References:
Clinical trial NCT00144573: Clinical Pharmacology Study of MRA in Patient With Rheumatoid Arthritis (RA) With Renal Impairment
Official title: An Open-Label, Clinical Pharmacology Study to Evaluate the Safety and PK of MRA in Patients With RA With Renal Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis
Lead sponsor: Chugai Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2005-09-05
Enrollment: 14
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is an open-label, clinical pharmacology study to evaluate the safety and PK of MRA in patients with RA with Renal Impairment.


Eligibility criteria: Inclusion criteria

* Patients who are diagnosed with RA according to the 1987 ACR (American College of Rheumatology) classification criteria
* Patients with RA at least 6 months prior to enrollment
* Patients with a creatinine clearance not less than 10 mL/min but no higher than 80 mL/min

Exclusion criteria

* Patients with Class IV Steinbrocker functional impairment at enrollment
* Patients who are undergoing dialysis
* Patients who have been treated for the underlying disease with a biological agent, such as infliximab or etanercept, and have been receiving treatment with leflunomide, within 12 weeks before treatment with the investigational product

Primary outcomes:
measure: 20% improvement based on the ACR criteria compared with the baseline value.
timeFrame: throughout study
Secondary outcomes:
measure: Time courses taken from baseline values for DAS28, for ACR20%, 50%, and 70% improvement, and for each ACR core set variable.
timeFrame: Week 0, Week 4
Other outcomes:
Locations:
Study officials:
affiliation: Chugai Pharmaceutical
name: Takahiro Kakehi
role: STUDY_DIRECTOR
References:
Clinical trial NCT02575573: Resuscitation Decisions in the Emergency Department (ED)
Official title: Influencing Factors on Resuscitation Decisions in the ED
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Resuscitation
Keywords: resuscitation decision
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: University of Basel
name: Max Planck Institute for Human Development
First posted: 2015-10-14
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Admitted patients from the Emergency Department of the University Hospital of Basel between the 1st of January 2010 and the 31st of December 2014.

Brief summary: The investigators will retrospectively examine the connection between resuscitation decisions of admitted patients at the ED of the University Hospital of Basel and several demographic and health related measures. Additionally there will be an examination, which patient characterestics may have lead to patients not having been asked about resuscitation decisions.


Eligibility criteria: Inclusion Criteria:

* Patients admitted to the emergency department (duration of hospitalisation more than 24 h).
* Patients with a research consent "yes".

Exclusion Criteria:

* Patients being discharged within less than 24 hours.
* Patients with a research consent "no".

Primary outcomes:
measure: Resuscitation decision of the patient
timeFrame: During stay at ED (range: <1 hour until 31 days)
Secondary outcomes:
measure: Patient characterestics, which may have lead to patients not having been asked about resuscitation decisions
timeFrame: During stay at ED (range: <1 hour until 31 days)
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel, Emergency Department
state: Baselstadt
Study officials:
affiliation: University Hospital Basel, Emergency Department
name: Roland Bingisser, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00076973: An Investigational Drug Study to Treat Respiratory Symptoms Associated With Respiratory Syncytial Virus (RSV) Bronchiolitis (0476-272)
Official title: A Randomized, 2-Period, Multicenter, Dble-Blind, Parallel-Group Study Comparing Effects of 2 Doses of MK0476 and Placebo in the Tx of Respiratory Symptoms Associated w/ Respiratory Syncytial Virus-Induced Bronchiolitis in Children 3 to 24 Mths
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bronchiolitis
Keywords: RSV Bronchiolitis
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2004-02-16
Enrollment: 1125
Sex: ALL
Minimum age (years): 3
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to look at whether an investigational drug can treat the breathing symptoms of RSV bronchiolitis in children 3 to 24 months of age.


Eligibility criteria: Inclusion Criteria:

* Hospitalized or in an urgent/emergent-care setting at least 24 hours for a first or second episode of RSV-induced bronchiolitis. Approximately twenty percent of patients will be allowed in the study with a stay of less than 24 hours but need to meet a minimum predefined Respiratory Severity Score as required by the study.

Exclusion Criteria:

* Asthma or other wheezing disorder. The Primary Investigator will evaluate whether there are other reasons why a child may not participate.

Primary outcomes:
measure: Percentage of Symptom-Free Days
Secondary outcomes:
measure: Percentage of Patients with Exacerbations and Percentage of Bronchiolitis-Free Days
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Bisgaard H, Flores-Nunez A, Goh A, Azimi P, Halkas A, Malice MP, Marchal JL, Dass SB, Reiss TF, Knorr BA. Study of montelukast for the treatment of respiratory symptoms of post-respiratory syncytial virus bronchiolitis in children. Am J Respir Crit Care Med. 2008 Oct 15;178(8):854-60. doi: 10.1164/rccm.200706-910OC. Epub 2008 Jun 26.