louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06479213: REACH (Restore Energy, Activity Can Help) Lupus Study
Official title: REACH (Restore Energy, Activity Can Help) Lupus Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Systemic Lupus Erythematosus
Fatigue
Keywords: Physical activity
Peer coaching
Mobile health application
Chronic disease self-management
Lead sponsor: Tufts Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
First posted: 2024-06-28
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this clinical trial is to pilot test the REACH peer coaching program for fatigue in people with systemic lupus erythematosus. The main questions it aims to answer are:

1. Is the REACH program feasible and acceptable to participants?
2. What is the impact of the REACH program on fatigue?

Researchers will compare the REACH peer coaching program to the REACH mobile health application to see if the REACH program works to reduce fatigue.

Participants will:

* Use the REACH mobile health application to set weekly movement goals and log daily physical activity
* Meet weekly with their REACH peer coach (if they have one) to talk about their movement goals and progress
* Complete weekly symptom surveys
* Complete study surveys when they start the program, in the middle of the program, at the end of the program, and 12 weeks after the program ends
* Participate in an interview to provide feedback on the program


Eligibility criteria: Inclusion Criteria:

* Diagnosis of systemic lupus erythematosus based on 2019 American College of Rheumatology classification criteria
* ≥ 18 years of age
* English-speaking
* Ownership of a smartphone
* Physician's permission to participate in the study (including engagement in physical activity)
* Fatigue Severity Scale score ≥ 4

Exclusion Criteria:

* Inability to consent or comply with the study protocol (cognitively impaired adults).

Primary outcomes:
measure: Feasibility
timeFrame: 6 months
measure: Adherence
timeFrame: 12 months
measure: Acceptability
timeFrame: 12 to 24 weeks
Secondary outcomes:
measure: Fatigue
timeFrame: 12 weeks and 24 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
Study officials:
References:
Clinical trial NCT01922713: Effect of Daily Consumption of Orange Maize on Breast Milk Retinol in Lactating Zambian Women
Official title: Effect of Daily Consumption of β-carotene Biofortified Maize on Milk Retinol Concentration in Lactating Zambian Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitamin A Deficiency
Keywords: biofortification
vitamin A
maize
beta-carotene
breastmilk
Zambia
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: Johns Hopkins University
name: Tropical Diseases Research Centre, Zambia
First posted: 2013-08-14
Enrollment: 149
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of the study is to determine whether daily consumption of beta-carotene biofortified maize will increase breast milk retinol concentration in lactating Zambian women.

Detailed description: Lactating women were randomly assigned to one of three intervention groups to receive 6d/wk for 3 wk either 1) provitamin A biofortified orange maize and a corn oil capsule, 2) white maize and a vitamin A capsule, or 3) white maize and a corn oil capsule. The 'orange maize' and 'vitamin A' groups received \~600 ug RAE/d as provitamin A biofortified maize or retinyl palmitate, respectively. The 'white maize' group was a negative control group that did not receive any supplemental vitamin A.

Eligibility criteria: Inclusion Criteria:

* Apparently healthy lactating women 18-35 years of age
* who are breastfeeding a single infant, 4-12 mo of age.

Exclusion Criteria:

* Pregnancy,
* Chronic disease,
* Hb concentration \<90 g/L,
* Signs or symptoms of vitamin A deficiency

Primary outcomes:
measure: Breast milk retinol concentration
timeFrame: After 3 weeks of intervention
Secondary outcomes:
measure: Breastmilk beta-carotene concentration
timeFrame: After 3 wk of intervention
Other outcomes:
measure: Plasma retinol concentration
timeFrame: After 3 wk of intervention
Locations:
city: Mkushi
country: Zambia
facility: Center for Human Nutrition
state: Mkushi District
Study officials:
affiliation: University of California, Davis
name: Marjorie Haskell, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Palmer AC, Chileshe J, Hall AG, Barffour MA, Molobeka N, West KP Jr, Haskell MJ. Short-Term Daily Consumption of Provitamin A Carotenoid-Biofortified Maize Has Limited Impact on Breast Milk Retinol Concentrations in Zambian Women Enrolled in a Randomized Controlled Feeding Trial. J Nutr. 2016 Sep;146(9):1783-92. doi: 10.3945/jn.116.233700. Epub 2016 Jul 27.
Clinical trial NCT01792713: Sertaconazole 2% Cream to Improve Symptoms Associated With Atopic Dermatitis
Official title: Randomisierte, Doppelblinde, Plazebo-kontrollierte Prüfung Zum Nachweis Der Wirksamkeit Und Der Lokalen Verträglichkeit Einer 2%Igen Sertaconazol-Crème Bei Patienten Mit Atopischer Dermatitis (Abridged)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Skin Alterations Associated With Atopic Dermatitis
Keywords: Skin alterations
Atopic Dermatitis
Lead sponsor: Spirig Pharma Ltd.
Sponsor class: INDUSTRY
First posted: 2013-02-15
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Investigation aimed to explore the efficacy of a topical Sertaconazole cream 2% in patients with skin alterations associated with atopic dermatitis


Eligibility criteria: Inclusion Criteria:

* Informed consent
* Atopic Dermatitis Patients with SCORing Atopic Dermatitis (SCORAD) ≤ 40
* Atopic lesion localisation: arms; additional legs, neck

Exclusion Criteria:

* SCORAD \> 40
* Unstable, uncontrolled medical status (e.g. active systemic or topical infection)
* Active immunosuppression or cancer
* Narcotics- or Alcohol abuse
* Participation in another clinical trial until one month prior inclusion
* Known allergies against an ingredient of the investigational medicinal product
* Different periods of grace for certain pre-treatments, e.g. topical corticosteroids, immune modulating drugs
* Pregnancy or lactation

Primary outcomes:
measure: Change in Patient Global Assessment (PGA)
timeFrame: day 1, day 28
Secondary outcomes:
measure: Change in Eczema Area and Severity Index (EASI)
timeFrame: day 1, day 28
measure: Change in Dermatology Life Quality Index (DLQI)
timeFrame: d1, d28
measure: Change in Patient Benefit Index (PBI)
timeFrame: day 1, day 28
Other outcomes:
measure: Change in Transepidermal water loss (TEWL)
timeFrame: d1, d14, d28, d42
Locations:
city: Berlin
country: Germany
facility: Universitätsmedizin Charité Berlin, Abteilung für Dermatologie und Allergologie
city: Münster
country: Germany
facility: Universitätsklinikum Münster, Klinik für Hautkrankheiten
Study officials:
References:
citation: Stander S, Metz M, Ramos F MH, Maurer M, Schoepke N, Tsianakas A, Zeidler C, Luger TA. Anti-pruritic Effect of Sertaconazole 2% Cream in Atopic Dermatitis Subjects: A Prospective, Randomized, Double-blind, Vehicle-controlled, Multi-centre Clinical Trial of Efficacy, Safety and Local Tolerability. Acta Derm Venereol. 2016 Aug 23;96(6):792-6. doi: 10.2340/00015555-2268.
Clinical trial NCT01734213: Efficacy and Safety of Eriobotyra Japonica Lindley Extract on Improvement of Cognitive Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Function
Lead sponsor: Chonbuk National University Hospital
Sponsor class: OTHER
First posted: 2012-11-27
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators performed a 12-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Eriobotyra Japonica Lindley Extract on improvement of Cognitive Function. The investigators measured improvement of Cognitive Function parameters , including K-MMSE, Ability to perform working memory tasks, CNT and BCRS, and monitored their blood pressure.


Eligibility criteria: Inclusion Criteria:

* Males and females ≥ 65 years old
* Able to give informed consent

Exclusion Criteria:

* History of underlying neurodegenerative disease such as Alzheimer's disease, and Parkinson's disease
* Subjects with medical conditions such as Severe Dementia
* Allergic or hypersensitive to any of the ingredients in the test products
* History of reaction to any of the test products or of gastrointestinal diseases such as Crohn's disease or gastrointestinal surgery
* History of alcohol or substance abuse
* Participation in any other clinical trials within past 2 months
* Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study etc.

Primary outcomes:
measure: Changes in K-MMSE(Korean Mini-Mental State Examination)
timeFrame: 12 weeks
measure: Changes in ability to perform working memory tasks
timeFrame: 12 weeks
Secondary outcomes:
measure: Changes in CNT(Computerized neurocognitive function test)
timeFrame: 12 weeks
measure: Changes in BCRS(Brief Cognitive Rating Scale)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Jeonju
country: Korea, Republic of
facility: Clinical Trial Center for Functional Foods; Chonbuk National University Hospital
state: Jeollabuk-do
Study officials:
References:
Clinical trial NCT01069913: Pharmacokinetics Profile Study of BG00012 Standard Formulation and BG00012 Active Pharmaceutical Ingredient
Official title: A Pharmacokinetics Profile Determination of BG00012 Standard Formulation and the BG00012 Active Pharmaceutical Ingredient (API) After a Single Oral Dose Administered to Healthy Male Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy Volunteer
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2010-02-17
Enrollment: 14
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study is to measure two different formulations of BG00012 to determine how much of each formulation of BG00012 reaches the blood stream and how long it takes the body to get rid of it, when given as a single dose.


Eligibility criteria: Inclusion Criteria:

1. Males 18 to 55 years old, inclusive, at the time of informed consent.
2. Must weigh between 50 kg and 110 kg, inclusive.
3. Must have a body mass index (BMI) between 19 kg/m2 and 30 kg/m2, inclusive.
4. All subjects must practice effective contraception during the study and be willing and able to continue contraception for 30 days after their last dose of study treatment.
5. Must be a non-smoker, and no use of chewing tobacco, for at least 6 months prior to Day -1.
6. Must have a screening physical examination and ECG without any clinically significant abnormality (as determined by the Investigator).

Exclusion Criteria:

1. History of malignancy (subjects with basal cell carcinoma that has been completely excised prior to study entry remain eligible).
2. History of severe allergic or anaphylactic reaction.
3. History of any clinically significant endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, and renal, or other major diseases, as determined by the Investigator.
4. Clinically significant abnormal hematology or blood chemistry values, as determined by the Investigator.
5. Serious infection (e.g., pneumonia, septicemia) within the 2 months prior to Day -1.

Primary outcomes:
measure: PK profiles of the current BG00012 standard formulation and the BG00012 API formulation in healthy volunteers. Primary PK parameter will be the area under the plasma concentration curve
timeFrame: 4 days post dosing period 2
Secondary outcomes:
measure: To assess the safety and tolerability of the current oral BG00012 standard formulation and the encapsulated oral BG00012 API
timeFrame: 4 days after dosing period 2
Other outcomes:
Locations:
Study officials:
affiliation: Biogen Idec, Cambridge, MA USA
name: Biogen Idec Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02089113: OTX-14-003: A Phase 3 Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Ocular Inflammation and Pain After Cataract Surgery
Official title: A Prospective, Multicenter, Randomized, Parallel-Arm, Double-Masked, Vehicle Controlled Phase 3B Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Ocular Inflammation and Pain After Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Post-Surgical Ocular Pain
Post-Surgical Ocular Inflammation
Lead sponsor: Ocular Therapeutix, Inc.
Sponsor class: INDUSTRY
First posted: 2014-03-17
Enrollment: 241
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 objective of the study was to evaluate the safety and efficacy of OTX-DP (dexamethasone insert) 0.4 mg for intracanalicular use when placed in the canaliculus of the eyelid for the treatment of post-surgical inflammation and pain in subjects who had undergone cataract extraction with intraocular lens implantation


Eligibility criteria: Inclusion Criteria:

* Has a cataract and is expected to undergo clear corneal cataract surgery with phacoemulsification and implantation of a posterior chamber lens
* Has a potential post-operative pinhole corrected Snellen VA of at least 20/200 or better in both eyes

Exclusion Criteria:

* Any intraocular inflammation in the study eye present during the screening slit lamp examination
* Score greater than "0" on the Ocular Pain Assessment in the study eye at Screening
* Any intraocular inflammation in the study eye present during the screening slit lamp examination

Primary outcomes:
measure: Number of Participants With an Absence of Anterior Chamber Inflammation
timeFrame: Day 14
measure: Number of Participants With an Absence of Ocular Pain
timeFrame: Day 8
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06540313: Efficacy, Safety and Neural Mechanism of Stellate Ganglion Block in the Treatment of Anxiety. Disorder.
Official title: Efficacy, Safety and Neural Mechanism of Stellate Ganglion Block in the Treatment of Anxiety.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Anxiety Disorders
Stellate Ganglion Block
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
First posted: 2024-08-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: 1. In this study, ultrasound-guided Stellate Ganglion Block(SGB) will be used in the treatment of anxiety disorders, combined with relevant scales, HRV indicators and resting state functional magnetic resonance data, to explore the safety and effectiveness of SGB in the treatment of anxiety disorders, and to explore whether its mechanism of action is related to the excitability of sympathetic nervous system and the activity changes of insular cortex.
2. Verify the following hypothesis:

(1) SGB is a safe, well-tolerated and acceptable treatment technique; (2) After SGB treatment, the anxiety symptoms of the patients were relieved to a certain extent and the psychological function was restored; (3) The sympathetic excitability of patients after SGB treatment is reduced, and this effect can be monitored by heart rate variability; (4) The activity of insular cortex decreased after SGB treatment.


Eligibility criteria: Inclusion Criteria:

1. Aged 18-60 years old
2. Diagnosed with various types of anxiety disorders according to the DSM-5, and meet the diagnostic criteria for pain disorders
3. Right-handed
4. Voluntarily join the study and sign the informed consent.

Exclusion Criteria:

1. Suicidal thoughts and behaviors
2. serious physical disease
3. diseases of the nervous system or other mental diseases
4. Contraindications for MRI examination
5. During pregnancy or lactation
6. Allergy to narcotic drugs
7. Contraindications with stellate ganglion block

Primary outcomes:
measure: Heart rate variability index
timeFrame: 8 weeks
measure: Insular cortex activity
timeFrame: 8 weeks
measure: Numeric Rating Scale
timeFrame: 8 weeks
measure: Hamilton Anxiety Rating Scale
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing Brain Hospital
state: Jiangsu
Study officials:
References:
Clinical trial NCT04378413: Aquatic and Land Exercises in Chronic Low Back Pain
Official title: The Effect of Aquatic and Land Exercises on Pain, Health Related Quality of Life, Kinesiophobia and Disability in Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low-back Pain
Keywords: Aquatic Exercises
Chronic Low Back Pain,
Land Exercises
Pain,
Functional status
Lead sponsor: Baskent University
Sponsor class: OTHER
First posted: 2020-05-07
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aquatic and Land Exercises on Chronic Low Back Pain

Detailed description: The Effect of Aquatic and Land Exercises on Pain, Health Related Quality of Life, Kinesiophobia and Disability in Chronic Low Back Pain

Eligibility criteria: Inclusion Criteria:

* patients had to be diagnosed with clinical examination and radiological findings of low back pain from at least 6 months.

Exclusion Criteria:

* acute pain

Primary outcomes:
measure: pain in low back pain after aqua and land exercises
timeFrame: 4 week
measure: quality of life after aqua and land exercises
timeFrame: 4 week
Secondary outcomes:
measure: disability in low back paitients after aqua and land exercise
timeFrame: 4 week
measure: kinesiophobia in low back paitients after aqua and land exercise
timeFrame: 4 week
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ayça Aytar
Study officials:
References:
Clinical trial NCT00178113: A Pilot Study of Lycopene Supplementation in Prostatic Intraepithelial Neoplasia
Official title: Phase I Clinical Trial: Randomized Lycopene Supplementation in Tobago Men With High-Grade Prostatic-Intraepithelial Neoplasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Prostatic Intraepithelial Neoplasia
Keywords: Prostatic Intraepithelial Neoplasia
Prostate-Specific Antigen
lycopene
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2005-09-15
Enrollment: 80
Sex: MALE
Minimum age (years): 40
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether dietary lycopene supplementation lowers serum prostate specific antigen(PSA) in men with high grade intraepithelial neoplasia (HGPIN).

Detailed description: Observational studies suggest higher lycopene intake or higher lycopene blood levels are associated with a lower risk for prostate cancer. Two recent trials of lycopene supplementation conducted in men with prostate cancer, during the three weeks prior to radical prostatectomy, found a reduction in serum PSA suggesting a regression of prostate cancer.

High grade intraepithelial neoplasia (HGPIN)is thought to be a precancerous lesion, and men with HGPIN have an elevated risk of prostate cancer diagnosis on subsequent biopsy. The objective of this study is to determine whether dietary lycopene supplementation lowers serum prostate specific antigen(PSA)over four months of supplementation. Serum PSA is compared in men randomized to 30 mg/day lycopene plus a standard multivitamin versus standard multivitamin alone.

Eligibility criteria: Inclusion Criteria:

* biopsy reported high grade prostatic intraepithelial neoplasia
* and/or biopsy reported atypia
* and/or persistently elevated serum prostate specific antigen with normal biopsy

Exclusion Criteria:

* biopsy diagnosed prostate cancer
* serum prostate specific antigen \> 40 ng/ml
* hospitalization in past six months
* history of allergy to tomatoes
* history of allergic dermatitis
* serious concurrent illness
* inability to provide informed consent

Primary outcomes:
measure: Serum PSA at randomization, one month, four months
Secondary outcomes:
measure: Serum lycopene at randomization, one month, four months
Other outcomes:
Locations:
city: Scarborough
country: Trinidad and Tobago
facility: Tobago Prostate Survey Office
state: Tobago
Study officials:
affiliation: University of Pittsburgh
name: Clareann H Bunker, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pittsburgh
name: Lewis H Kuller, MD
role: STUDY_DIRECTOR
References: