louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03968536: Measuring the Impact of a Multimodal Intervention on Falls and Fear Falls Among People 65 Years Old, Residents at Home
Official title: Measuring the Impact of a Multimodal Intervention on Falls and Fear Falls Among People 65 Years Old, Residents at Home
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fall
Old Age; Atrophy
Lead sponsor: Gérond'if
Sponsor class: OTHER
First posted: 2019-05-30
Enrollment: 71
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Autonomous elderly people walking

Brief summary: Measuring the Impact of a Multimodal Intervention on Falls and Fear Falls among People 65 Years Old, Residents at Home in Boulogne city

Detailed description: We hypothesize that participation in the multimodal program " Autonomy Prevention Kit " would lead to a decrease in falls and the fear of falling.

this study targets retired people, 65 years of age and over, living at home, identified as being independent (Iso Group Resources type 4-5-6 without formal validation being carried out) but who represent statistically an increased risk of falls in comparison to the general population.

The inclusion takes place before the first session of the Equilibr'Age® workshop. Subjects will have already benefited from a first collective information organized by the Boulogne City Council (see annexes of the CRF). 3 times mark the collection of data.

At the time of inclusion, at the end of the 12 sessions of the Equilbr'Age® workshop (M3) and 3 months after the end of the workshop ( 6 months after the beginning of inclusion).

The study does not involve new acts since it is only an assessment of the effects of a protocol that proposes non-sports activities as well as advice to citizens of the municipality.

Eligibility criteria: Inclusion Criteria:

* Retired
* Age ≥ 65 years;
* GIR ≥ 4
* Commitment to participate in all interventions of the "autonomy prevention" Kit
* Autonomous in its travels
* The person expressed no objection to participating in the KitPA study.

Exclusion Criteria:

* In professional activity
* Age \< 65 years;
* GIR \< 4
* Person under guardianship or curatorship

Primary outcomes:
measure: Comparison of the number of falls before/after and the fear of falling before/after according Equilibr'Age® workshop
timeFrame: 6 months
Secondary outcomes:
measure: Comparison of life quality before/after according EQ-ED scale
timeFrame: 6 months
Other outcomes:
measure: Assesssment of health status according Self Perceived Health (SPH) scale
timeFrame: 6 months
measure: Assessment of the impacte of workshops according Likert scale
timeFrame: 6 months
Locations:
city: Paris
country: France
facility: Gerond'if
state: Ile De France
Study officials:
affiliation: Gérond'if
name: Frederic Nicolas, master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00910936: Exercise for Patients With HIV Infections
Official title: Effects of an Exercise Program on Metabolic Parameters of Patients With a HIV Infection.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: HIV Infections
Lipodystrophy
Inflammation
Keywords: HIV
Exercise
Inflammation
Quality of life
Lipodystrophia
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2009-06-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The investigators will evaluate the effects of an endurance exercise program on the physical performance, the well being, and indicators of metabolic function in patients with an HIV infection.


Eligibility criteria: Inclusion Criteria:

* Age 18 to 65
* HIV infection
* Antiviral therapy
* Understanding of written German

Exclusion Criteria:

* Diabetes mellitus
* All conditions which can be aggravated by exercise

Primary outcomes:
measure: Maximal oxygen uptake (VO2max)
timeFrame: At recruitment and after 12 weeks
Secondary outcomes:
measure: Quality of life
timeFrame: At recruitment and after 12 weeks
measure: Indicators of fat metabolism
timeFrame: At recruitment and after 12 weeks
measure: Markers of inflammation
timeFrame: At recruitment and after 12 weeks
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Section Sports Medicine, Charité Universitätsmedizin Berlin, Hindenburgdamm 30
Study officials:
affiliation: Charite University, Berlin, Germany
name: Fernando Dimeo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02338336: A Phase I/II Double-blind Safety and Efficacy Evaluation of Nowarta110 in Patients With Plantar Warts
Official title: A Phase I/II, Two- Staged Randomized, Double-blind Study to Evaluate the Safety and Efficacy of Nowarta110 in Patients With Plantar Warts and Clinical Recovery Successfully Completed
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Plantar Warts
Lead sponsor: Nowarta Biopharma Inc
Sponsor class: INDUSTRY
First posted: 2015-01-14
Enrollment: 54
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: To evaluate drug safety and efficacy in patients treated with Nowarta110 and to determine therapeutic activity against Plantar Warts

* Clinical Tolerance
* Clinical Recovery
* Evaluate Safety

Detailed description: Plantar Warts occur on the soles (plantar surface of feet) and can be severely debilitating for patients even for normal walking. The severity and magnitude of the warts can vary, but they are the cause of much pain and discomfort for all age groups. Nowarta 110 has been evaluated for the therapy of plantar warts caused by the HPV virus, (HPV infection). Clinical experience in a totals of 124 patients receiving Nowarta 110 for 5 weeks treatment in multiple clinics overseas has demonstrated the potential of Nowarta110 with absolutely no side effect.

Eligibility criteria: Inclusion Criteria:

* Patients with refractory or recurrent Plantar Warts.
* No wart treatment for the last 12 weeks
* Healthy male or non-pregnant, non-lactating female aged ≥ 18 years or greater
* If female of childbearing potential, use an acceptable form of birth control during the study
* Provide written informed consent or (HIPAA consent/authorization, as applicable

Exclusion Criteria:

* Concurrent medical disorder or disease making implementation or interpretation of the protocol or results difficult or unsafe
* Female subjects who are breast-feeding or planning to become pregnant
* Patients with a history of allergy to silver or fruits
* Subjects with clinically significant unstable medical disorder, life threatening disease, or current malignancies
* Subjects with History of Alcohol abuse or other drug abuse within 2 years prior to Randomization
* Subjects who have been treated with an investigational drug or investigational device within a period of 30 days prior to study enrollment
* Concomitant Medications: any other wart therapy is prohibited during the study.

Primary outcomes:
measure: Lesion Assessment
timeFrame: 6 weeks
measure: Incidence of Zero Lesion Measurement
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Huntington Beach
country: United States
facility: Nowarta Biopharma Inc
state: California
Study officials:
affiliation: Chairman
name: Dr. Iraj E Kiani
role: STUDY_CHAIR
References:
Clinical trial NCT01220336: Study of Medical Assistant Health Coaching in Primary Care for Patients With Chronic Conditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Hypertension
Hyperlipidemia
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2010-10-13
Enrollment: 441
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Randomized control trial studying the effect of medical assistant health coaching for patients with diabetes, hypertension and hyperlipidemia within two San Francisco primary care community clinics, Mission Neighborhood Health Center and Southeast Health Center


Eligibility criteria: Inclusion Criteria:

Active patients at Mission Neighborhood Health Center, SF, USA or Southeast Health Center, SF, USA age 18-75 years Uncontrolled diabetes II, hypertension or hyperlipidemia Spanish or English speaking

Exclusion Criteria:

Cognitive dysfunction, mental health or physical condition that prevents participation in health coaching.

Primary outcomes:
measure: Composite clinical outcome measure- improvement in either HgA1C, SBP, or LDL
timeFrame: 12 months
Secondary outcomes:
measure: Composite clinical outcome measure- improvement in either HgA1C, SBP, or LDL
timeFrame: 24 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Mission Neighborhood Health Center
state: California
city: San Francisco
country: United States
facility: Southeast Health Center
state: California
Study officials:
affiliation: University of California, San Francisco
name: Ellen Chen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: David Thom, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Willard-Grace R, DeVore D, Chen EH, Hessler D, Bodenheimer T, Thom DH. The effectiveness of medical assistant health coaching for low-income patients with uncontrolled diabetes, hypertension, and hyperlipidemia: protocol for a randomized controlled trial and baseline characteristics of the study population. BMC Fam Pract. 2013 Feb 23;14:27. doi: 10.1186/1471-2296-14-27.
Clinical trial NCT03660436: An Investigational Study of Experimental Medication BMS-986165 in Healthy Participants
Official title: An Open-label, Single-sequence Study to Investigate the Effects of BMS-986165 at Steady State on the Single Dose Pharmacokinetics of Mycophenolate Mofetil (MMF) in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2018-09-06
Enrollment: 131
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the effects of experimental medication BMS-986165 in healthy male participants.


Eligibility criteria: For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Healthy participant, as determined by no clinically significant deviation from normal in physical examination, electrocardiograms (ECGs), and clinical laboratory determinations
* Body mass index of 18.0 to 32.0 kg/m2, inclusive, and weight ≥ 50 kg, at screening
* Normal renal function at screening as evidenced by an estimated GFR (glomerular filtration rate) \> 80 mL/min/1.732 m2

Exclusion Criteria:

* Any medical condition that presents a potential risk to the participant and/or may compromise the objectives of the study, including a history of or active liver disease
* Positive anti- John Cunningham virus (JCV) antibody test at Screening
* History of allergy to MMF, BMS-986165, related compounds or any significant drug allergy

Other protocol defined inclusion/exclusion criteria could apply

Primary outcomes:
measure: Maximum plasma concentration (Cmax) of mycophenolic acid (MPA)
timeFrame: 18 days
measure: Area under the concentration vs time curve from time zero to the last quantifiable plasma concentration (AUC[0-T]) of MPA
timeFrame: 18 days
measure: AUC extrapolated to infinity (AUC[INF]) of MPA
timeFrame: 18 days
Secondary outcomes:
measure: Number of adverse events (AE)
timeFrame: Up to 48 days
measure: Number of serious adverse events (SAE)
timeFrame: Up to 48 days
measure: Number of AEs leading to discontinuation
timeFrame: Up to 48 days
measure: Incidence of clinically significant changes in laboratory test results, vital sign measurements, electrocardiograms (ECGs) and physical examination results
timeFrame: 18 days
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: PRA Health Sciences
state: Utah
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT01208636: Environmental & Genetic Influences on Vitamin D Status
Official title: Environmental & Genetic Influences on Vitamin D Status
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vitamin D Deficiency
Keywords: Vitamin D deficiency
Sun
Genetics
Lead sponsor: Creighton University
Sponsor class: OTHER
Collaborators: name: Procter and Gamble
First posted: 2010-09-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will include 50 "healthy" unrelated community dwelling males or females.

The subjects will be between ages 18-60.

Brief summary: The purpose of this study is to determine the effect of environmental and genetic influences on Vitamin D status.

Detailed description: Vitamin D deficiency is a common problem. The principal source of vitamin D for humans is solar exposure, with cutaneous synthesis of vitamin D by photoconversion of 7-dehydrocholesterol in the skin to pre-vitamin D3. Latitude, altitude, season, skin pigmentation, and age are recognized factors that influence how much vitamin D can be made by solar exposure. Surprisingly, Vitamin D deficiency has been described in people dwelling in southern Florida and in surfers in Hawaii. We hypothesize that genetic variations in vitamin metabolism accounts for these differences.

Eligibility criteria: Inclusion Criteria:

* Able to consent and come for a study visit.
* Male or female between ages 18-60.
* Sun exposure \>3 hours daily for at least 5 days weekly for the last 3 months.

Exclusion Criteria:

* Unable to consent or come to a visit
* Taking Vitamin D supplements, anticonvulsants, barbiturates, steroids, having granulomatous disease, or liver or kidney disease as these medications and conditions interfere with Vitamin D metabolism.
* Related to another participant by blood.

Primary outcomes:
measure: 25(OH)D levels
timeFrame: 1 month
Secondary outcomes:
measure: Genetic testing of 13 candidate genes
timeFrame: 1 month
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Creighton University
state: Nebraska
Study officials:
affiliation: Creighton University
name: Laura Armas, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00021736: Phase II/III Study of Anti-VEGF in Neovascular AMD
Official title: Phase II/III Randomized, Double-Masked, Trial, to Establish the Safety and Efficacy of Intravitreal Injections of EYE001 (Anti-VEGF Pegylated Aptamer) Given Every 6 Weeks for 54 Weeks, in Patients With Exudative AMD).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Macular Degeneration
Choroidal Neovascularization
Keywords: choroidal neovascularization (CNV)
subretinal neovascularization
Lead sponsor: Eyetech Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2001-08-06
Enrollment: 540
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine whether the anti-VEGF drug is effective at stabilizing and/or improving vision in patients with the wet form of AMD

Detailed description: This will be a randomized, double-masked, controlled, dose-ranging, multi-center comparative trial, in parallel groups. Patients will be stratified by clinical center, by percentage of classic CNV vessels: \[predominantly classic (\>50%) vs. minimally classic (1-49%) vs. purely occult (0%)\], and according to whether, or not, they have received prior PDT with Visudyne (no more than once). All patients will be re-randomized after 54 weeks of treatment to either, continue or discontinue therapy for further 48 weeks.

Eligibility criteria: Patients of either gender, aged 50 years or above, diagnosed with subfoveal CNV secondary to AMD and with best corrected visual acuity of 20/40 to 20/320 in the absence of subfoveal atrophy or scarring in the study eye, and better or equal to 20/800 in the fellow eye, may be enrolled. Clinically significant concomitant diseases will be excluded.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Foundation for Fighting Blindness
state: Maryland
Study officials:
References:
Clinical trial NCT01199536: Helicobacter Pylori Eradication Treatment in Patients With Duodenal Ulcers
Official title: Observational Study to Evaluate Helicobacter Pylori Eradication at the End of Routine Triple Eradication Therapy With Duodenal Ulcer Relapses Control.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Duodenal Ulcer
Keywords: Helicobacter-positive duodenal ulcer
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-09-13
Enrollment: 59
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: Hospital patients

Brief summary: The Study purpose is to evaluate Helicobacter pylori susceptibility to Clarithromycin and to estimate eradication and healing rates of duodenal ulcer routine eradication therapy at the end of treatment and 52 weeks from the therapy start


Eligibility criteria: Inclusion Criteria:

* Active duodenal ulcer with duodenal ulcer exacerbation confirmed by endoscopic signs of duodenal ulcer disease (acute ulcer or scar deformity of the duodenal bulb) and anamnesis data.
* Helicobacter pylori positive diagnosis at entry by 13C-Urea Breath Test (UBT)
* Prescription of the standard 7-day eradication therapy including esomeprazole 20 mg bd, amoxicillin 1000 mg bd, clarithromycin 500 mg bd
* Written informed consent provided prior the start of participation in the study.

Exclusion Criteria:

* Subjects who are unwilling or unable to provide informed consent
* Current complication of duodenal ulcer disease, e.g. perforation, bleeding or pyloric stenosis
* History of esophageal/gastric/duodenal surgery except of the patients underwent perforated ulcer closure or endoscopic hemostasis more than 6 months ago
* Contraindications to Esomeprazole, Amoxicillin or Clarythromycin including known or suspected hypersensitivity or allergy
* Treatment with Amoxicillin, Clarythromycin or Bismuth containing drugs one month prior to inclusion
* Two or more previous attempts to eradicate H. Pylori

Primary outcomes:
measure: Eradication rate of H. pylori at the end routine triple eradication therapy
timeFrame: 1 year
Secondary outcomes:
measure: Recurrence rate of duodenal ulcer (in patients with ulcer defects in inclusion stage)
timeFrame: 2 years
measure: Frequency of duodenal ulcer relapses
timeFrame: 2 years
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Research Site
Study officials:
affiliation: Head of Chair of Internal Diseases Propedeutics and Gastroenterology at MMA n/a I.M. Sechenov
name: Vladimir T. Ivashkin
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04361136: Clinical Trial to Evaluate Light-induced Skin Reactions After Application of Delgocitinib Cream
Official title: A Phase 1 Clinical Trial to Evaluate the Phototoxic Potential of Delgocitinib Cream After Single Topical Occlusive Application on Healthy Skin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: LEO Pharma
Sponsor class: INDUSTRY
First posted: 2020-04-24
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All subjects will receive all treatments with treatments randomised over test fields.
Primary purpose: OTHER

Brief summary: This is a single-centre, randomised, vehicle-controlled, double-blind, within-subject comparison phase 1 clinical trial. The trial is designed to find out if delgocitinib cream can cause skin irritation after light exposure in people with healthy skin.


Eligibility criteria: Key Inclusion Criteria:

* Healthy subjects aged 18-64 years (inclusive).
* Fitzpatrick skin type of I, II, or III.

Key Exclusion Criteria:

* Atopic dermatitis, eczema, psoriasis, acne, dermatitis solaris or suntan that could interfere with the test field evaluation, hyperpigmentation, multiple naevi, tattoos, blemishes or dense body hair in the range of the test fields.
* Any history of or presence of cancerous or precancerous skin lesions.
* Any other skin disease or other visible skin condition noted on physical examination which in the investigator's opinion might interfere with the evaluation of the test field reaction.
* Known disease that can be induced by ultraviolet (UV) light.
* Use of any topical or systemic medication which could interfere with the trial objective within 2 weeks before randomisation until end of trial.
* Use of drugs which might cause photobiologic or phototoxic reactions within 4 weeks before randomisation until end of trial.
* Foreseeable intensive UV light exposure (solar or artificial) to test fields within 4 weeks before randomisation until end of trial.

Primary outcomes:
measure: Positive skin reaction at 24 hours or 48 hours after irradiation
timeFrame: Up to 48 hours after irradiation
Secondary outcomes:
measure: Positive skin reaction at 24 hours after irradiation
timeFrame: 24 hours after irradiation
measure: Positive skin reaction at 48 hours after irradiation
timeFrame: 48 hours after irradiation
Other outcomes:
measure: Number of treatment-emergent adverse events from baseline to Day 4
timeFrame: From time of first investigational medicinal product application (Day 1) until Day 4
Locations:
city: Hamburg
country: Germany
facility: Bioskin Research Center Dermatology
Study officials:
affiliation: LEO Pharma
name: Medical Expert
role: STUDY_DIRECTOR
References: