louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05991713: Geolocation Positional System (GPS) Experience
Official title: Individual Differences in Emotional and Behavioral Patterns and Their Relationship to Cognition
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Emotions
Anhedonia
Depression
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2023-08-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to use smartphone technology to capture individual location emotional and cognitive data, to examine how real-world behaviors thoughts, emotions, and brain activity are related to one another.

Detailed description: The observational portion of this study was initially approved in 2015, this is a subset of the initially approved study and it is a clinical trial of 100 participants.

Eligibility criteria: Inclusion Criteria:

* Must agree to give informed consent
* Must be willing to have an functional Magnetic Resonance Imaging (FMRI) scan
* Must be able to receive and respond to daily text messages assessing current emotion
* Must be willing to download and run a GPS tracking application (FollowMee) onto their smartphone for a four-month period

Exclusion Criteria:

* history of head trauma, seizures, or neurological disorders
* severe/unstable medical conditions
* conditions that interfere with MRI
* pregnancy
* lifetime psychotic/bipolar disorder
* chronic/severe substance or alcohol abuse/dependence
* antipsychotic medication

Primary outcomes:
measure: Change in positive emotional response as measured by ecological momentary assessment
timeFrame: Baseline, up to 6 months
Secondary outcomes:
measure: Change in negative emotional response as measured by ecological momentary assessment
timeFrame: Baseline, up to 6 months
Other outcomes:
Locations:
city: Coral Gables
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Aaron S Heller, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04499313: Dexamethasone Vs Methylprednisolone for the Treatment of Patients With ARDS Caused by COVID-19
Official title: The Outcome of Dexamethasone and Methylprednisolone Treatment for Patients With ARDS Caused by COVID-19
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Covid19
ARDS
Keywords: COVID 19
Dexamethasone
Methylprednisolone
ARDS
Lead sponsor: Chattogram General Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Xi'an Jiaotong University
First posted: 2020-08-05
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized clinical trial designed and intended to evaluate the efficacy of Dexamethasone and Methylprednisolone as a treatment for severe Acute Respiratory Distress Syndrome (ARDS) caused by coronavirus disease 19 (COVID-19). Our aim is to find the best option for the treatment and management of ARDS in COVID-19 patients.


Eligibility criteria: Inclusion Criteria:

• Moderate to severe COVID-19 requires hospitalization. SARS-CoV-2 infection will be confirmed by RT PCR / CT Chest in every case.

Exclusion Criteria:

* Participants with uncontrolled clinical status who were hospitalized from the before.
* Contraindication / possible drug interaction.
* Participants who have any severe and/or uncontrolled medical conditions like, Severe ischemic heart disease, epilepsy, malignancy, Pulmonary/renal/hepatic disease, pregnancy, Corpulmonale, etc.

Primary outcomes:
measure: Mortality rate (In hospital)
timeFrame: Following randomization 30 days.
measure: Clinical improvement
timeFrame: Following randomization 30 days.
Secondary outcomes:
measure: Ventilator free days
timeFrame: Following randomization 30 days.
measure: Changes in Oxygen level
timeFrame: Following randomization 30 days.
Other outcomes:
Locations:
city: Chittagong
country: Bangladesh
facility: Chattogram General Hospital
city: Dinajpur
country: Bangladesh
facility: M. Abdur Rahim Medical College Hospital
Study officials:
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Abu Taiub Mohammed Mohiuddin Chowdhury, MBBS, MD
role: STUDY_DIRECTOR
affiliation: First Affiliated Hospital Xi'an Jiaotong University
name: Abu Taiub Mohammed Mohiuddin Chowdhury, MBBS, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01105013: Evaluate the Efficacy and Safety of Tolnaftate Cream in the Treatment of Patients With Fungal Infections
Official title: Study Clinical, Multicenter, Phase III, to Evaluate the Efficacy and Safety of Tolnaftate Cream in the Treatment of Patients With Fungal Infections Like Tinea Foot, Tinea and Tinea Crural Body"
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Fungal Infections
Tinea Pedis
Tinea Cruris
Tinea Corporis
Keywords: fungal infections
tinea
tonaftato
Lead sponsor: Laboratório Teuto Brasileiro S/A
Sponsor class: INDUSTRY
First posted: 2010-04-16
Enrollment: 90
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a study clinical, multicenter, Phase III trial, to evaluate the efficacy and safety of tolnaftate cream in the treatment of patients with fungal infections such as Tinea foot, Tinea and Tinea crural body.

Detailed description: Study Clinical, multicenter, Phase III, to evaluate the efficacy and safety of 10mg/g tolnaftate cream in the treatment of patients with fungal infections such as Tinea foot, Tinea and Tinea crural body.

Eligibility criteria: Inclusion Criteria:

* Patients of both sexes, of any race, aged 12 years;
* Ability to understand and sign the IC (for patients older than age) in the case of minors monitoring and consent of a guardian;
* Clinical diagnosis of fungal infections for tinea pedis (ringworm of the feet) or tinea cruris (ringworm of the groin region), or tinea corporis (ringworm in other body areas);
* Direct mycological exam positive for fungi;

Exclusion Criteria:

* Pregnant women or nursing mothers;
* Use of topical or oral antifungal;
* Use of steroids;
* Allergy or hypersensitivity to any component of product;
* Clinical cases of tinea infection by bacteria and / or eczema, tinea extensive and onychomycosis.

Primary outcomes:
measure: Evaluate the efficacy and safety of the tolnaftate cream 10 mg / g.
timeFrame: 97 days
Secondary outcomes:
Other outcomes:
Locations:
city: Santo André
country: Brazil
facility: Faculdade de Medicina do ABC
state: São Paulo
Study officials:
affiliation: PHC - Pharma Consulting
name: Dagoberto Brandão
role: STUDY_DIRECTOR
References:
Clinical trial NCT03802513: Somatosensory Tinnitus Study
Official title: A New Therapeutic Approach for Somatosensory Tinnitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tinnitus
Keywords: tinnitus
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2019-01-14
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Somatosensory tinnitus is suspected when the tinnitus perception changes following head, neck, or jaw maneuvers. The prevalence of this type of tinnitus in Veterans in unknown. The Cleveland Clinic evaluates all tinnitus patients for this condition and when detected, prescribes individualized physiotherapy. Cleveland Clinic's novel approach to tinnitus assessment and management provides the framework for this proof of concept pilot study.

Detailed description: Phase 1A involves adapting Cleveland Clinic's assessment and treatment approach for somatosensory tinnitus to make it feasible for a VA population.

Phase 1B involves screening Veterans with tinnitus to evaluate and describe the prevalence of somatosensory tinnitus (in Veterans with tinnitus).

Phase 2 involves Veterans with somatosensory tinnitus receiving 3 individualized physical therapy sessions using the adapted approach developed during Phase 1A.

Phase 3 will evaluate the feasibility and tolerability of the adapted treatment approach.

Eligibility criteria: Inclusion Criteria:

* Veteran
* chronic tinnitus
* positive screen for somatosensory tinnitus

Exclusion Criteria:

* Non-Veteran
* participation in new (\< 1 month) tinnitus management or treatment
* current participation in tinnitus research involving an intervention

Primary outcomes:
measure: Tinnitus Functional Index
timeFrame: Baseline and 1 month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: VA Portland Health Care System, Portland, OR
state: Oregon
Study officials:
affiliation: VA Portland Health Care System, Portland, OR
name: Sarah Theodoroff, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00852813: Tolerance and Prebiotic Activity of Arabinoxylan-Oligosaccharides in Healthy Subjects
Official title: Tolerance and Prebiotic Activity of Arabinoxylan-Oligosaccharides in Healthy Subjects: a Randomized, Placebo-Controlled Cross-Over Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy
Keywords: tolerance
prebiotic
gastrointestinal effects
Lead sponsor: KU Leuven
Sponsor class: OTHER
First posted: 2009-02-27
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the tolerance of a higher dose of arabinoxylan-oligosaccharides (AXOS) and their prebiotic activity in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* healthy
* 18-45 years
* regular eating pattern

Exclusion Criteria:

* gastrointestinal complaints
* antibiotic intake
* medication influencing gut transit or microbiota
* abdominal surgery
* pregnancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Department of Gastrointestinal Research, Laboratory Digestion and Absorption
Study officials:
affiliation: KU Leuven
name: Kristin Verbeke, PhD
role: STUDY_DIRECTOR
References:
citation: Cloetens L, De Preter V, Swennen K, Broekaert WF, Courtin CM, Delcour JA, Rutgeerts P, Verbeke K. Dose-response effect of arabinoxylooligosaccharides on gastrointestinal motility and on colonic bacterial metabolism in healthy volunteers. J Am Coll Nutr. 2008 Aug;27(4):512-8. doi: 10.1080/07315724.2008.10719733.
Clinical trial NCT06574113: Validation of Cuffless Blood Pressure Measurements Using the Perin Health Patch
Official title: Validation of Cuffless Blood Pressure Measurements Using the Perin Health Patch
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Blood Pressure
Keywords: Cuffless blood pressure
Wearable device
Lead sponsor: Perin Health Devices
Sponsor class: INDUSTRY
First posted: 2024-08-27
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of male and female adult participants aged 18 years or older who are willing and able to provide informed consent and comply with the study procedures. Participants may be healthy or have comorbidities, so long as participants are members of any 'Special Population' as defined by the AAMI standards, including but not limited to pregnant individuals, children, and those with an arm circumference greater than 42 cm. Due to the nature of the investigational device, individuals with pacemakers or a history of reactions to medical adhesives may not participate.

Brief summary: This study aims to validate a proprietary cuffless blood pressure algorithm using measurements from a multi-modal chest-worn medical device, the Perin Health Patch (PHP).

Detailed description: The study will compare the performance of the PHP to an ambulatory blood pressure cuff across 85 subjects for a 10-minute monitoring period, followed by an optional cold pressor test and an additional 10-minute monitoring period. The study aims to confirm that the calibrated measurement from the wearable device meets AAMI performance standards.

Eligibility criteria: Inclusion Criteria:

* Adults aged 18 years or older,
* Willing and able to provide informed consent,
* Able to comply with study procedure.

Exclusion Criteria:

* Any member defined under 'Special Population' in the AAMI standards (Pregnant, children, arm circumference \> 42 cm),
* Patient with a pacemaker,
* History of reactions to medical adhesives,
* Inability to comply with the study procedure,
* Non-English Speaker.

Primary outcomes:
measure: Cuffless blood pressure measurement performance
timeFrame: 3 months
Secondary outcomes:
measure: Demographic performance variance
timeFrame: 3 months
Other outcomes:
Locations:
city: Woodland Hills
country: United States
facility: Perin Health Devices
state: California
Study officials:
affiliation: Perin Health Devices
name: Ian M McLane, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04503213: A Study to Assess CSF1R-related Leukoencephalopathy After Stem Cell Transplantation
Official title: Longitudinal Assessment of CSF1R-Related Leukoencephalopathy Following Stem Cell Transplantation
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: CSF1R-related Leukoencephalopathy
ALSP
POLD
Hematopoietic Stem Cell Transplantation
Keywords: HDLS, Leukoencephalopathy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-08-07
Enrollment: 20
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: Subjects will be identified through the Mayo Clinic Florida Neurology and/or Hematology Departments. Qualifying individuals will be identified on the basis of a genetically-confirmed diagnosis of CSF1R-related leukoencephalopathy and a tentative treatment plan including haematopoietic stem cell transplantation (HSCT).

Brief summary: The purpose of this study is to measure the effect of Hematopoietic Stem Cell Transplantation (HSCT) on symptoms of CSF1R-related Leukoencephalopathy.

Detailed description: The purpose of this study is to measure the effect of Hematopoietic Stem Cell Transplantation (HSCT) on symptoms of CSF1R-related Leukoencephalopathy.

Eligibility criteria: Inclusion Criteria:

* ≥ 18 years of age.
* Genetic confirmation of a mutation in the CSF1R gene.
* Diagnosis of CSF1R-related leukoencephalopathy.
* Anticipated to undergo haematopoietic stem cell transplantation (HSCT).

Exclusion Criteria:

* Concurrent diagnoses that may confound neuropsychological testing; e.g., major hearing/visual impairment.
* Concurrent diagnoses that may confound ambulatory measurements; e.g., amputee.
* Inability to undergo magnetic resonance imaging (MRI); e.g., MR-incompatible implant.

Primary outcomes:
measure: Improvement in cognitive and motor function
timeFrame: Through study completion, approximately 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Zbigniew K Wszolek, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00469313: Efficacy of Inspiratory Muscle Training on Inspiratory Capacity in Patients With COPD
Official title: Efficacy of Inspiratory Muscle Training on Inspiratory Capacity in Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COPD
Keywords: copd
inspiratory muscle training
IF
Lead sponsor: Hospital Hietzing
Sponsor class: OTHER
First posted: 2007-05-04
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: Hypothesis:benefits of inspiratory muscle strenght training with Respifit S decreases symptoms, disability or handicap of patients affected by COPD. The inspiratory fraction (inspiratory capacity IC/ total lung capacity TLC)may be functionally more representative than other traditional indices.


Eligibility criteria: Inclusion Criteria:

* COPD GOLD II-III (FEV1\<80 and \>30%)

Exclusion Criteria:

* Pregnancy
* Lung cancer
* Diabetes mellitus
* Primary exacerbation of COPD

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Hospital Hietzing
Study officials:
affiliation: Hospital Hietzing, A 1130, Vienna, Austria
name: Michael Reiter
role: STUDY_CHAIR
References:
citation: Petrovic M, Reiter M, Zipko H, Pohl W, Wanke T. Effects of inspiratory muscle training on dynamic hyperinflation in patients with COPD. Int J Chron Obstruct Pulmon Dis. 2012;7:797-805. doi: 10.2147/COPD.S23784. Epub 2012 Nov 30.
Clinical trial NCT01188213: Efficacy of Methylsulfonylmethane Supplementation on Osteoarthritis of The Knee: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Osteoarthritis
Lead sponsor: Assaf-Harofeh Medical Center
Sponsor class: OTHER_GOV
First posted: 2010-08-25
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT

Brief summary: The aim of this study was to determine the efficacy of methylsulfonylmethane (MSM) in treating patients with knee OA.


Eligibility criteria: Inclusion Criteria:

* symptomatic knee OA for at least 6 months according to the clinical criteria of the American College of Rheumatology (ACR)
* radiographic confirmed knee OA according to the Kellgren \& Lawrence scale

Exclusion Criteria:

* acute septic arthritis
* inflammatory arthritis
* any other type of arthritis
* history of knee buckling or recent knee injury
* lack of physical or mental bility to perform or comply with the treatment procedure
* diabetes mellitus
* fibromyalgia or other chronic pain syndromes
* concurrent anti-coagulant/anti-platelet drugs
* arthroscopy or intra-articular injections in the previous 3 months

Primary outcomes:
measure: WOMAC questionnaire
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Debbi EM, Agar G, Fichman G, Ziv YB, Kardosh R, Halperin N, Elbaz A, Beer Y, Debi R. Efficacy of methylsulfonylmethane supplementation on osteoarthritis of the knee: a randomized controlled study. BMC Complement Altern Med. 2011 Jun 27;11:50. doi: 10.1186/1472-6882-11-50.
Clinical trial NCT01426113: A Study of the Safety and Efficacy of Bimatoprost Ophthalmic Solution in Paediatric Patients With Glaucoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Glaucoma
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2011-08-31
Enrollment: 6
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety and efficacy of a new formulation of bimatoprost ophthalmic solution compared to timolol ophthalmic solution in the treatment of paediatric patients with glaucoma.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of congenital, juvenile glaucoma
* Requires treatment with IOP-lowering medication in one or both eyes

Exclusion Criteria:

* Surgical intervention is indicated or planned to lower IOP
* Abnormally low body weight (below 5th percentile)
* Any active eye infection or disease
* Anticipated use of contact lenses during the study
* Topical ocular steroid use within 2 months
* History of ocular trauma in either eye
* Required chronic use of ocular medications (other than study medication) during the study (intermittent use of artificial tears permitted)

Primary outcomes:
measure: Change From Baseline in Intraocular Pressure (IOP) in the Study Eye
timeFrame: Baseline, Week 6
Secondary outcomes:
Other outcomes:
Locations:
city: Louisville
country: United States
state: Kentucky
city: Amiens
country: France
city: Milan
country: Italy
city: Parma
country: Italy
city: Seoul
country: Korea, Republic of
city: Makati
country: Philippines
city: Taguig
country: Philippines
city: Taipei
country: Taiwan
city: London
country: United Kingdom
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01150513: Docetaxel+Carboplatin vs Epirubicin+Cyclophosphamide Followed by Docetaxel as Adjuvant Treatment in Triple-negative Breast Cancer
Official title: Docetaxel Plus Carboplatin Versus Epirubicin Plus Cyclophosphamide Followed by Docetaxel as Adjuvant Treatment in Triple-negative Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Breast Cancer
Keywords: TRIPLE-NEGATIVE
BREAST CANCER
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2010-06-25
Enrollment: 320
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Triple-negative breast cancer (TNBC) has a relatively bad prognosis whereas there is no standard regimen. Some data showed that platins could improve the efficacy of advance TNBC. In this trial, it is the hypothesis that TP (docetaxel plus carboplatin) has a better efficacy than EC-T (epirubicin plus cyclophosphamide followed by docetaxel).


Eligibility criteria: Inclusion Criteria:

* Triple-negative breast cancer
* Older than 18 years old
* Have tumor resection surgery
* Sufficient organ function (marrow, heart, liver)

Exclusion Criteria:

* Other malignancy
* Other serious disease( marrow, heart, liver)

Primary outcomes:
measure: Disease Free Survival (DFS) of 3 years
timeFrame: 3 years after mastectomy
Secondary outcomes:
measure: Safety Profiles
timeFrame: Up to 24 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Institute & Hospital Chinese Academy of Medical Sciences
Study officials:
affiliation: Chinese Academy of Medical Sciences
name: Peng Yuan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zheng F, Du F, Wang W, Wang Y, Li M, Zhao J, Wang X, Yue J, Wang J, Yang Z, Cai R, Ma F, Fan Y, Li Q, Zhang P, Xu B, Yuan P. Updated efficacy of adjuvant epirubicin plus cyclophosphamide followed by taxanes versus carboplatin plus taxanes in early triple-negative breast cancer in phase 2 trial: 8.1-year median follow-up. Breast Cancer Res Treat. 2022 Jan;191(1):97-105. doi: 10.1007/s10549-021-06401-6. Epub 2021 Oct 14.