louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01349608: Physical Activity Coaching in Chronic Obstructive Pulmonary Disease (COPD)
Official title: Physical Activity Coaching in COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Physical Activity
Health Behavior
Keywords: Chronic Obstructive Pulmonary Disease
Motivational Interviewing
Health Coaching
Physical Activity
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2011-05-06
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is designed to explore a new approach to help people with chronic obstructive pulmonary disease (COPD) become more physically active. Through weekly telephone sessions with a health coach utilizing motivational interviewing, participants will be empowered to set goals for increased physical activity (emphasis on walking). The objective of the study is to determine if telephone-based health coaching is a reasonable and effective way to increase physical activity, as measured by a gold-standard activity monitor, in people with COPD.


Eligibility criteria: Inclusion Criteria:

* Men and women age 40 years and older
* Current or former cigarette smoker of at least 10 pack-years
* Diagnosis of COPD stage II to IV COPD as documented by pulmonary function testing (FEV1 \<80% predicted, FEV1/FVC ration \<0.71) within the past 24 months
* Able to ambulate independently or with a walking aid (wheeled or standard walker or cane)

Exclusion Criteria:

* Unable to walk without assistance of another person
* patients with a high likelihood of being lost to follow-up or contact (patients with active chemical dependency), are planning to move out of the state, are not able to be contacted by telephone
* patients with an inability to provide good data or follow commands (patients who are disoriented or have a severe neurologic/psychiatric condition)

Primary outcomes:
measure: Effectiveness of telephone-based health coaching in COPD.
timeFrame: 3 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Roberto P Benzo, M.D., MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00144508: Phase III Comparative Study(Open-Label) of MRA for Rheumatoid Arthritis(RA)
Official title: An Open-Label, Phase III Study to Evaluate the Efficacy and Safety of MRA in Patients With RA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Lead sponsor: Chugai Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2005-09-05
Enrollment: 306
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate clinical efficacy and tolerability of MRA, patients with RA are randomized to receive either MRA or conventional DMARDs.


Eligibility criteria: Inclusion criteria

* Diagnosed as having RA, on the basis of the criteria stipulated by the American Conference on Rheumatism (ACR) in 1987.
* With RA that has continued for at least 6 months but less than 5 years, with the date of first appearance being taken as the date of RA diagnosis.
* Active RA despite at least one DMARD or immunosuppressant. Active disease is defined as having at least 6 tender and 6 swollen joints among 49 and 46 joints stipulated by the Japanese Rheumatism Foundation's Drug Evaluation Committee and ESR at least 30 mm/hr and CRP not less than 2.0mg/dL.

Exclusion criteria

* Shown to have class-IV Steinbrocker's functional activity in an evaluation carried out within 4 weeks before administration of the study drug.
* Treated with drugs that delay joint destruction (infliximab, etanercept, leflunomide, etc.) within 3 months before administration of the study drug.
* The oral corticosteroid dose (prednisolone equivalent of up to 10 mg/day)has not been fixed 2 weeks before administration of the study drug.
* Subjected to any of the following within 4 weeks before administration of the study drug: (i) Change in dosage of currently administered DMARDs and/or immunosuppressive agents. (ii) Plasma exchange method. (iii) Surgical treatment (operations, etc.).

Primary outcomes:
measure: Change in the erosion score, as determined by the modified Sharp method.
timeFrame: week 52
measure: Frequency and severity of adverse events and adverse drug reactions
timeFrame: throughout study
Secondary outcomes:
measure: Change in the erosion score
timeFrame: week 28
measure: Changes in the joint space narrowing score and total Sharp score
timeFrame: week 28, 52
Other outcomes:
Locations:
Study officials:
affiliation: Chugai Pharmaceutical
name: Takahiro Kakehi
role: STUDY_DIRECTOR
References:
Clinical trial NCT03670108: "SMS - Heals My Health"
Official title: Impact of Personalized SMS in Relay of Therapeutic Education Programs to Improve the Physical Activity of Patients in Rheumatology
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: to Help Improve the Quality of Life of Patients
Lead sponsor: Hôpital Cochin
Sponsor class: OTHER
First posted: 2018-09-13
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with osteoporosis or inflammatory rheumatism aged between 18 and 75 years, who participated in the patient's therapeutic education program

Brief summary: Therapeutic patient education is an approach that has shown its usefulness in rheumatology, but the duration of its impact is limited, and therapeutic revisions are regularly necessary. The practice of physical activity is one of the goals of TPE in rheumatology and new technologies, such as SMS messages represent a possible complementary tool to amplify behavioral changes The study primary objective is to evaluate the impact of individualized SMS compared to standard SMS messages on the physical activity of patients with chronic inflammatory rheumatism or osteoporosis, included in a therapeutic education program. Our hypothesis is that individualized SMS has a higher efficiency compared to standard SMS messages to increase the practice of physical activity in these patients.


Eligibility criteria: Inclusion Criteria:

* patient age from 18 to 75 years
* Participated in therapeutic patient education program osteoporosis disease and inflammatory rheumatism disease
* Having given their written consent
* French speaking
* Possessing a telephone tool that accepts SMS

Exclusion Criteria:

* Patients unable to read SMS for practical, linguistic or cognitive reasons
* Patients who can not, for medical reasons or disability, set up 30 minutes of moderate physical activity (walking or other moderate activity) per day
* Having already participated in a similar study in inflammatory rheumatism or osteoporosis
* Already having the required level of physical activity: performing more than 30 minutes of moderate physical activity (walking or other moderate activity)

Primary outcomes:
measure: physical activity
timeFrame: 1 YEAR
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Cochin Hospital
Study officials:
References:
Clinical trial NCT02930408: Compare Train and 3D-4D Left Ventricular Systolic Function in Subjects Suffering From Dystrophy and Healthy Subjects
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Steinert's Disease
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2016-10-12
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT

Brief summary: Steinert's disease is an orphan disease. The prognosis of patients with this disease is conditioned by cardiac involvement. Search an early stage alterations in contractile function in subjects suffering from dystrophy would detect patients at risk of sudden death. The first stage of work is to validate the tools to detect early stage of infringement systolic function in a population of patients with myotonic dystrophy.


Eligibility criteria: Inclusion Criteria:

* patients suffering from muscular dystrophy type 1 followed CHU Poitiers.
* age ≥ 18 years

Exclusion Criteria:

* duration QRS\> 120 ms ECG permanent ventricular stimulation
* trouble segmental kinetic obvious to echocardiography in visual analysis

Primary outcomes:
measure: Ventricular Ejection Fraction Left 3D
timeFrame: Immediately
measure: Global longitudinal systolic Strain
timeFrame: Immediately
measure: Strain of the dispersion index
timeFrame: Immediately
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01215708: Effects of the Use of Adjuvant Drugs After Extracorporeal Shockwave Lithotripsy (ESWL) in Renal Calculus
Official title: Effect of Tamsulosin and Nifedipine on the Elimination of Fragments After Extracorporeal Shock Waves Lithotripsy in Patients With Kidney Stones - a Prospective, Double-blind and Randomized Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Renal Calculi
Keywords: Kidney calculi
Lithotripsy
Calcium channel blockers
Adrenergic alpha-antagonists.
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
First posted: 2010-10-06
Enrollment: 136
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 investigators objective is to study if some drugs can improve the success rate of extracorporeal shockwave lithotripsy for renal stones.

Detailed description: Extracorporeal shockwave lithotripsy is one of the modalities of treatment of renal stones. It´s a machine that breaks the renal stones extracorporeally. Some drugs, like alpha blockers and calcium channel blockers, can improve the success rates of this procedure. Our objective is to study the real effects of two drugs, tamsulosin and nifedipine, compared to placebo, in the elimination of fragments after the extracorporeal shockwave lithotripsy treatment.

Eligibility criteria: Inclusion Criteria:

* radiopaque renal stone, 5 to 20 mm, located at renal pelvis or superior or middle calix

Exclusion Criteria:

* inferior calix, any contraindication for extracorporeal shockwave lithotripsy, pregnancy, coagulopathy, previous renal surgery, age under 18, abdominal aorta aneurism and urinary infection.

Primary outcomes:
measure: To evaluate the effects of Tamsulosin and Nifedipine in the success rates after treatment of radiopaque renal stones between 5-20 mm with only one session of SWL
timeFrame: 30 days
Secondary outcomes:
measure: To evaluate the effects of Tamsulosin and Nifedipine in the episodes of pain after treatment of radiopaque renal stones between 5-20 mm with only one session of SWL
timeFrame: 30 days
measure: To evaluate the effects of Tamsulosin and Nifedipine in the velocity of elimination of fragments after treatment of radiopaque renal stones between 5-20 mm with only one session of SWL
timeFrame: 30 days
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Clinics Hospital of University of Sao Paulo
Study officials:
affiliation: University of Sao Paulo
name: Miguel Srougi, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05859308: A Novel Virtual Reality Task in Parkinson's Disease
Official title: A Crossover Pilot Study of a Novel Virtual Reality Task in Parkinson's Disease Compared to a Group In-Person Rock Steady Boxing Program; Task Performance, Cognitive Outcomes, Perceptions, and Comparisons
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: New York Institute of Technology
Sponsor class: OTHER
First posted: 2023-05-15
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare experiences and effects of a virtual reality physical program to an in-person Rock Steady Boxing Program. People with Parkinson's disease, age 18 and up, who participate in Rock Steady Boxing weekly may join this study.

Detailed description: If you agree to be in this study, we will ask you to do the following things:

Provide basic information about yourself, complete tests of thinking on the computer and in person, participate in your regular Rock Steady boxing, and for three weeks replace your Rock Steady Boxing with a virtual reality game done with a headset. You will work independently with a study team member.

* Visit 1 or Visit 1 and 2 if split up: Beginning Measures/Demographics, Parkinson's disease symptoms, Cognition (about 45 minutes), VR training (30 minutes) or Regular Rock Steady Boxing (1 hour)
* Visit 2-5: Virtual Reality training (30 minutes or Regular Rock Steady Boxing (1 hour)
* Visit 6: Virtual Reality training (30 minutes) or Regular Rock Steady Boxing (1 hour), Cognitive measures (about 20 minutes)
* Visit 7: Cognitive measures (about 20 minutes), Virtual Reality training (30 minutes) or Regular Rock Steady Boxing (1 hour); Intrinsic Motivation Inventory (5 minutes)
* Visit 8-11: Virtual Reality training (30 minutes) or Regular Rock Steady Boxing (1 hour)
* Visit 12 or Visit 13 if baseline was split up: Virtual Reality training (30 minutes) or Regular Rock Steady Boxing (1 hour), Cognitive Measures (20 minutes), Intrinsic Motivation Inventory (5 minutes), End of Study Survey (5-10 minutes)

Eligibility criteria: Inclusion criteria:

* Diagnosed with Parkinson's disease
* Age 18+ years
* Currently involved in rock steady boxing
* Willing to participate 2-3 days/week

Exclusion criteria:

* Known history of movement-induced vertigo
* Other cognitive or movement disorders

Primary outcomes:
measure: Stroop Test, Inquisit Millisecond
timeFrame: through study completion, an average of one year
Secondary outcomes:
Other outcomes:
Locations:
city: Old Westbury
country: United States
facility: NYIT
state: New York
Study officials:
affiliation: NYIT
name: Amber Sousa, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05625308: Effect of Natural Compounds on the Severity of HPV-induced Cervical Lesions
Official title: Effect of Natural Compounds on the Severity of HPV-induced Cervical Lesions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Papilloma
Cervix Lesion
Lead sponsor: Lo.Li.Pharma s.r.l
Sponsor class: INDUSTRY
First posted: 2022-11-22
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: 40 HPV-positive women displaying chronic cervicitis, mild dysplasia or moderate dysplasia.
Primary purpose: TREATMENT

Brief summary: To test the efficacy of a newly-commercialized formula, 40 HPV-positive women displaying chronic cervicitis, mild dysplasia or moderate dysplasia. Women in the study group took one tablet per day containing 200 mg of EGCG, 400 mcg of Folic Acid, 1 mg of Vitamin B12 and 50 mg of Hyaluronic Acid for twelve weeks. Women in the control group received no treatment.


Eligibility criteria: Inclusion Criteria:

* HPV infections
* Occurrence of low-grade cervical lesions

Exclusion Criteria:

* Diagnosis of malignancy or severe cervical lesions
* Concurrent uterine pathologies
* Pregnancy or intended to seek pregnancy in the next three months
* Cancer

Primary outcomes:
measure: Regression of cervical lesions
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Clinica Alma Res
Study officials:
affiliation: Clinica Alma Res
name: Cesare Aragona, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02250508: A Study to Compare the Pharmacokinetics and Safety of Optivate® and Haemate P® in Patients With Von Willebrand Disease.
Official title: A Randomised, Comparative, Single Dose, Open Study to Compare the Pharmacokinetics and Safety of Optivate® and Haemate P® in Patients With Different Types of Von Willebrand Disease.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: vonWillebrand's Disease
Lead sponsor: Bio Products Laboratory
Sponsor class: OTHER
First posted: 2014-09-26
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The main objectives of the study were

* to compare the pharmacokinetics (PK) of Optivate® and Haemate P® in various types of vonWillebrand disease (VWD) using the results from the VWF: RCo, VWF:Ag, VWF:CBA and Factor VIII assays.
* to compare the clinical tolerance and safety of these two treatments after single IV infusions in subjects with VWD.


Eligibility criteria: Inclusion Criteria:

* Previously treated subjects of at least 12 years of age, with any type of VWD were eligible for entry into this study.

Exclusion Criteria:

-

Primary outcomes:
measure: AUC (0-48h) for VWF: RCo
timeFrame: Pre-dose, 30 min, 1, 2, 5, 8, 24, 48 hours post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Hematology Dept., Sackler School of Medicine, Tel Aviv University
Study officials:
References:
Clinical trial NCT03885908: Automated Geriatric Co-Management Program in Older Patients With Solid Mass or Nodule Suspicious for Cancer
Official title: Feasibility and Effectiveness of Automated Geriatric Co-Management Program on Improving the Perioperative Care of Older Patients With Solid Mass or Nodule Suspicious for Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cancer
Keywords: Automated Geriatric Co-Management Program
Perioperative Care
Solid mass
Nodule
19-066
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2019-03-22
Enrollment: 20
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The proposed study is a randomized controlled trial study.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to find out if it is possible to use the automated geriatric co-management program to manage the participants care before, during and after surgery.


Eligibility criteria: Inclusion Criteria:

* Solid mass or nodule suspicious for cancer
* Aged 65 or older
* Being considered for surgical resection of the solid mass or nodule, with anticipated hospital length of stay of at least two days,
* Completed the eRFA per routine care

Exclusion Criteria:

* Unable to read or comprehend English
* Not having a completed electronic Rapid Fitness Assessment within 2 months of surgery\*\*Note) To avoid excluding patients based this item, patients have to complete another eRFA within two months of surgery.
* Being discharged in one day or earlier from the hospital.

Primary outcomes:
measure: Feasibility of Automated Geriatric Co-management Program
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Armin Shahrokni, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00736008: Thrombophilic Risk Factors in Pediatric Patients Diagnosed at the Ha'Emek Medical Center
Official title: The Study Will Summarize the Clinical and Laboratory Data of All the Pediatric Patients Diagnosed With Thrombotic Events at the Pediatric Hematology Unit
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thrombosis
Keywords: Factor V Leiden
Prothrombin Mutation
Hypercoagulability
Pediatrics
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2008-08-15
Enrollment: 100
Sex: ALL
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population cohort will include about 100 patients diagnosed with thrombotic events at the Pediatric Hematology Unit

Brief summary: The study will assess the clinical and laboratory data of about 100 pediatric patients diagnosed and treated at the Pediatric Hematology Unit during the years 1980 until 2007 because of thrombotic events.

The results, the treatment given, and the outcome of the patients will be summarized.


Eligibility criteria: Inclusion Criteria:All the patients diagnosed since 1980.

Exclusion Criteria:Patients with insufficient data records.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Pediatric Hematology Unit - Ha'Emek Medical Center
Study officials:
affiliation: Pediatric Hematology Unit - Ha'Emek Medical Center - Afula - 18101 - Israel
name: Carina Levin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Pediatric Dpt B - Ha'Emek Medical Center - Afula - Israel
name: Ayala Mari, Student
role: PRINCIPAL_INVESTIGATOR
References: