louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02562937: Reducing Sedentary Behaviour in University Students Using Text Messages
Official title: Reducing Sedentary Behaviour In University Students Using A Text Message-Based Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sedentary Lifestyle
Lead sponsor: Western University, Canada
Sponsor class: OTHER
First posted: 2015-09-29
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary purpose of the current study was to determine whether a text message intervention would increase break frequency and length of break from sitting, time spent standing, and time spent in light and moderate intensity physical activity in university students

Detailed description: Sedentary behaviour (SB) has been linked to many health problems (e.g., type 2 diabetes, heart disease). Interventions aimed at office workers, overweight and obese individuals have proven successful in reducing SB; however, no studies have examined university students.Text message-based interventions have succeeded to aid in smoking cessation and increase both physical activity and healthy eating, but have not been shown to reduce SB. Eighty-two university students were randomized into intervention (SB related text messages) or control (text messages unrelated to SB) groups. Participants received daily text messages and reported various SBs (i.e., breaks from sitting, standing, light and moderate intensity physical activity) at four time points (baseline, 2, 4 and 6 weeks).

Eligibility criteria: Inclusion Criteria:

* be able to read and write English
* own a cell phone with unlimited incoming text messages
* be a student at Western University

Exclusion Criteria:

* be under 18 or over 64

Primary outcomes:
measure: Change in length of break from sitting in minutes
timeFrame: baseline, 2, 4, and 6 weeks
measure: Change in frequency of break from sitting in minutes
timeFrame: baseline, 2, 4, and 6 weeks
measure: Change in minutes spent standing
timeFrame: baseline, 2, 4, and 6 weeks
measure: Change in minutes spent in light intensity physical activity
timeFrame: baseline, 2, 4, and 6 weeks
measure: Change in minutes spent in moderate intensity physical activity
timeFrame: baseline, 2, 4, and 6 weeks
Secondary outcomes:
measure: Change in self-efficacy for sedentary behaviour measured by percentage of confidence
timeFrame: baseline, 2, 4, and 6 weeks
Other outcomes:
Locations:
Study officials:
References:
citation: Cotten E, Prapavessis H. Increasing Nonsedentary Behaviors in University Students Using Text Messages: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2016 Aug 19;4(3):e99. doi: 10.2196/mhealth.5411.
Clinical trial NCT02020837: A Pilot Study Assessing the Effect of Lymphaticovenous Micro-Anastomosis in the Treatment of Postmastectomy Lymphedema
Official title: A Pilot Study Assessing the Effect of Lymphaticovenous Micro-Anastomosis in the Treatment of Postmastectomy Lymphedema
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: EARLY_PHASE1
Conditions: Lymphedema
Post Mastectomy
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2013-12-25
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A lymphatic diversion with lymphaticovenous microanastomosis will be performed.
Primary purpose: TREATMENT

Brief summary: This study will assess the impact of lymphaticovenous microanastomosis in volume reduction of postmastectomy upper extremity lymphedema. We hypothesize that multiple lymphaticovenous micro-anastomosis in the distal arm will result in the reduction of volume and improvement in quality of life of patients with post-mastectomy lymphedema


Eligibility criteria: Inclusion Criteria:

* Subject is 18-70 years of age
* Subject is Stage II-IV unilateral lymphedema

Exclusion Criteria:

* Subject is less than 6 months from completion of cancer treatment
* Subject has allergic reaction to the lymphatic contrast agent (Indocyanine Blue)
* Subject is medically unfit for the procedure
* Subject is unable to complete the follow-up visits
* Women with a positive urine pregnancy test are excluded from this study; women of childbearing potential (defined as those who have not undergone a hysterectomy or who have not been postmenopausal for at least 24 consecutive months) must agree to refrain from breast feeding and practice adequate contraception as specified in the informed consent. Adequate contraception consists of oral contraceptive, implantable contraceptives, injectable contraceptives, a double barrier method, or abstinence.
* Subject has bilateral lymphedema

Primary outcomes:
measure: Changes Relative to Baseline in the Volume of the Affected Limb at 3 and 6 Months From Surgery
timeFrame: 3 and 6 months from surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Mauricio Moreno, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02860637: Level and Degree of Spinal Cord Injury and Its Impact on Male Sexual Function
Official title: Level and Degree of Spinal Cord Injury and Its Impact on Male Sexual Function
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Cord Injury
Keywords: Sexuality
Spinal cord injuries
Penile erection
erectile dysfunction
Lead sponsor: Universidade Federal de Pernambuco
Sponsor class: OTHER
First posted: 2016-08-09
Enrollment: 45
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Observational study, conducted between March 2015 and ending in January 2016, with males, aged between 18 and 60 years; clinical diagnosis of traumatic spinal cord injury, injury time equal to or greater than six months, heterosexual and sexually active.

Brief summary: In addition to the motor and sensory functions, sexual function changes after spinal cord injury and is considered one of the most common problems, ranging from a decrease in sexual desire to disturbances of erection, orgasm and ejaculation.

Objective: To assess the impact of the complexity of traumatic spinal cord injury in male sexual function.

Detailed description: Methods: Observational study (CEAC 41221414.5.0000.5208) conducted with 45 men, mean age 34 (CI 31.5 to 37.1), with spinal cord injury and active sex life. Sexual function was assessed by the International Index of Erectile Function (IIEF) and level and degree of injury were determined following the guidelines of the International Standards for Neurological and Functional Examination Classification of Spinal Cord Injury. Data were collected after at least six months of injury in referral hospitals. Descriptive statistics and bivariate analysis were applied to observe the association between sexual function and complexity of the lesion, with a 0.05 significance level.

Eligibility criteria: Inclusion Criteria:

* men
* aged between 18 and 60 years
* clinical diagnosis of traumatic spinal cord injury
* injury time equal to or greater than six months
* heterosexual
* sexually active.

Exclusion Criteria:

* patients with erectile dysfunction attributed to endocrine or metabolic disease order
* those who underwent surgery as radical prostatectomy or penile implant
* cognitive impairment.

Primary outcomes:
measure: Sexual function
timeFrame: one day
Secondary outcomes:
measure: Degree of neurological lesion
timeFrame: one day
measure: Level of neurological lesion
timeFrame: one day
Other outcomes:
Locations:
city: Recife
country: Brazil
facility: Josepha Karinne de Oliveira Ferro
state: Pernambuco
Study officials:
affiliation: Universidade Federal de Pernambuco
name: Josepha KO Ferro, master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05185037: NIBP (Non-invasive Blood Pressure) Algorithm Enhancements (Characterize the Robustness of Motion Artifact Suppression)
Official title: NIBP Algorithm Enhancements - MA_PM_NIBP Algorithm Enhancements_2021_11266
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Movement, Involuntary
Lead sponsor: Philips Clinical & Medical Affairs Global
Sponsor class: INDUSTRY
First posted: 2022-01-11
Enrollment: 17
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant Laboring Females scheduled for Caesarean Section Delivery

Brief summary: The study intervention consists of a non-invasive blood pressure (NIBP) measurement device and cuff (FDA-cleared Philips IntelliVue X3 Rev. N.04 patient monitor) running a non-approved modified software containing an enhanced measurement algorithm for NIBP.

Detailed description: The purpose of this study is to compare measurements of NIBP taken by the study device and measurements taken by the current FDA-approved algorithm included in Rev. N.0 software for the IntelliVue patient monitors during motion artifact in patients undergoing caesarian section deliveries under epidural anesthesia.

Eligibility criteria: Inclusion Criteria:

* Obstetric patient at Yale New Haven Hospital
* Receiving epidural anesthesia
* Age at least 18 years
* Willing and able to provide informed consent in a Sponsor approved language
* Willing and able to comply with study-related procedures
* Priority classification II, III, or IV

Exclusion Criteria:

* Non-caesarian section deliveries
* Ruptured uterus, prolonged fetal bradycardia, cord prolapse, or other emergent condition
* Procedures under general anesthesia
* Altered mental status
* Currently participating in another clinical trial with any product, treatment and/or medication that clinically interferes with the study endpoint(s)
* Priority classification I or V

Primary outcomes:
measure: NIBP measurements with no technical alarms/INOPs
timeFrame: 1 Visit
measure: NIBP measurements with Diastolic, Systolic, and mean pressure within a physiologically plausible range for the patient population, treatment, and medication
timeFrame: 1 Visit
measure: NIBP measurements with pulse pressure greater than 20% of the systolic blood pressure
timeFrame: 1 visit
Secondary outcomes:
measure: Number of minutes between valid NIBP measurements compared to SoC
timeFrame: 1 visit
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
affiliation: Yale New Haven Hospital
name: Aymen Alian, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02585037: Changes in Grip Strength by Using Bandage Kinesio Taping
Official title: Changes in Grip Strength by Using Bandage Kinesio Taping
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hand Strength
Lead sponsor: University of Mogi das Cruzes
Sponsor class: OTHER
First posted: 2015-10-23
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The Kinesio Taping® method, therapeutic bandage, is another feature can be used in physical therapy, aiming to muscle enhancement, weakened muscles correction, analgesia, among others, by cutaneous stimulation of mechanoreceptors. This study aims to evaluate the efficiency of the use and effects offered by Kinesio Taping® method, changes in muscle strength of grip in normal subjects for clinical application.

Detailed description: A sample of 45 subjects will be divided randomly into three groups (G1: muscle activation technique; G2: muscle inhibition technique; G3: Placebo Effect) aged over 18 years male or female, where it will be initially measured the strength of grip with a dynamometer Jamar® pressure. Then the Kinesio Taping® bandage will be applied in an "I" format in the wrist flexor muscles of a dominant and non-dominant limb in G1, G2, and G3 groups. Investigators will follow the application protocol suggested by method of technical. To provide the facilitation of muscle activity (G1 group) a Kinesio Taping® bandage will be applied to the muscle starting at its origin up to the location of muscle insertion. For inhibition of muscle activity (G2 group), the bandage will be placed over the muscle starting at the insertion location and ending at the muscle origin. For the control group (G3 group) the bandage will be placed from the lateral extremity to the medial axis. The measurement of grip strength was carried out in four stages: immediately before placing the Kinesio Taping®, 24 h, 48 h, and 72 h after its application. After collecting the data statistical Investigators will held the analysis of the data.

Eligibility criteria: Inclusion Criteria:

* Men or women aged greater than 18 years and with muscle / nerve integrity of upper limbs, hearing and responsive to verbal commands with understanding the information that aware and according to the study.

Exclusion Criteria:

* Individuals who refused to participate in this research and / or do not meet the inclusion criteria.

Primary outcomes:
measure: Change handgrip strength at 72 hours
timeFrame: 24, 48 and 72 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Mogi das Cruzes
name: Silvia R. Boschi, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01586637: Art Therapy to Treat Women With Fibromyalgia
Official title: Assessment of Art Therapy Program for Women With Fibromyalgia: Randomized, Controlled, Blinded Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Fibromyalgia
Keywords: Fibromyalgia
Art Therapy
Pain
Quality of life
Body Image
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2012-04-27
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Effectiveness of an art therapy program for the treatment of pain and improvements in both quality of life and body image of patients with fibromyalgia.

Detailed description: Fibromyalgia (FM) is a chronic non-inflammatory syndrome characterized by diffuse pain throughout the body, sleep disorder, stiffness, fatigue, depression and other psychological problems. Patients with FM feel incapable of performing the majority of activities of daily living. Medication offers only short-term benefits. Thus, it is necessary to include other measures for treatment, such as physical activity and patient education. Art therapy combine the field of psychology with artistic activities, working with therapeutic and instructive aspects as well as the potential for personal growth contained in all forms of art.

Eligibility criteria: Inclusion Criteria:

* Classification of fibromyalgia by ACR criteria (Wolf et al, 1990)
* Females
* Without distinction of race
* Age 18 to 65 years
* Do not have changed treatment for fibromyalgia for at least 3meses
* signing the consent form

Exclusion Criteria:

* Other ostearticulares rheumatic and painful
* Decompensated cardio-respiratory diseases
* Perform physical activity more than 2x a week for more than 3 months

Primary outcomes:
measure: Change in Pain
timeFrame: baseline, after 10 weeks, 20 weeks and 40 weeks
Secondary outcomes:
measure: Change in fibromyalgia impact
timeFrame: Baseline, after 10, 20 and 40 weeks
measure: Change in Quality of life
timeFrame: Baseline, after 10, 20 and 40 weeks
measure: Change in Body image
timeFrame: Basline, after 10, 20 and 40 weeks
measure: Change in Functional capacity
timeFrame: Baseline, after 10, 20 and 40 weeks
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Andréia Salvador Baptista
Study officials:
affiliation: Federal University of São Paulo
name: Andréia S Baptista, PT, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05290337: ZR-CHOP in DLBCL With Specific Gene Abnormality
Official title: Phase 2 Study of Zanubrutinib Plus RCHOP (ZR-CHOP) in Newly Diagnosed Diffuse Large B-cell Lymphoma With Specific Gene Abnormality
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Diffuse Large B Cell Lymphoma
Keywords: Zanubrutinib
gene mutation
MYC translocation
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2022-03-22
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a phase 2, single center clinical trial. to evaluating the efficacy and safety of Zanubrutinib in combination with R-CHOP in newly diagnosed diffuse large B-cell lymphoma with specific gene abnormality.

Detailed description: This is a phase 2, single center clinical trial. to evaluating the efficacy and safety of Zanubrutinib in combination with R-CHOP in newly diagnosed diffuse large B-cell lymphoma with specific gene abnormality, including MYC translocation, MYD88 mutation, CD79B mutation, NOTCH1 mutation and TP53 mutation. all patients received 6 cycle therapy.

Eligibility criteria: Inclusion Criteria:

1. 18-75 years old;
2. histological confirmed, newly-diagnosed diffuse large B-cell lymphoma with one of the following gene abnormality including MYC translocation, MYD88 mutation, CD79B mutation, NOTCH1 mutation and TP53 mutation;
3. Eastern Cooperative Oncology Group (ECOG) status of 0-1; 4) hospitalized patients and received the whole cycle treatment in Fudan University Shanghai Cancer Center-
4. normal hematological, hepatic and renal function.
5. Life expectancy of more than 3 months;
6. Patients had at least one measurable target lesion;
7. LVEF ≥ 50%
8. signed informed consent forms

Exclusion Criteria:

1. hypersensitivity to immunoglobulin;
2. primary central nerves lymphoma
3. History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix;
4. With contraindication of steroid including uncontrolled diabetes;
5. Serious uncontrolled diseases and intercurrent infection;
6. Pregnant or lactating women;
7. hepatitis B infection with HBV-DNA ≥ 104

Primary outcomes:
measure: 3-year progression free survival
timeFrame: assessed up to 36 months
Secondary outcomes:
measure: Objective response rate
timeFrame: assessed up to 36 months
measure: 3-year event free survival
timeFrame: assessed up to 36 months
measure: 3-year overall survival
timeFrame: assessed up to 36 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
References:
Clinical trial NCT00706537: Phase 1 Pharmacokinetic Study Of CP-945598 In Patients With NASH
Official title: A Multiple Dose, Randomized, Double-Blind (3rd Party Open), Placebo-Controlled Phase 1 Study To Evaluate The Pharmacokinetics And Safety Of CP-945598 In Subjects With Nonalcoholic Steatohepatitis (NASH)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Non-Alcoholic Steatohepatitis(NASH)
Keywords: Pharmacokinetic safety NASH patients
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-06-27
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: CP-945598 is a potent and selective Cannabinoid-1 (CB1) receptor antagonist currently being developed for the treatment of obesity. CP-945598 is also being considered as a potential treatment for non-alcoholic steatohepatitis (NASH). This study will investigate the steady-state safety, toleration and pharmacokinetics of multiple oral dose administration of CP-945598. Results will be used to estimate the pharmacokinetic characteristics in NASH patients and underwrite the safety of this compound prior to any further studies in NASH patients.


Eligibility criteria: Inclusion Criteria:

* Body Mass Index (BMI) of 25 to 40 kg/m2
* Subjects with biopsy evidence of NASH in the 2 years prior to the screening visit.

Hemoglobin ≥11 g/dL, platelet count ≥100,000 cells/mm3, neutrophil count ≥1,500cells/mm3.

Exclusion Criteria:

* Other forms than NASH liver disease.
* Decompensated or severe liver disease.

Primary outcomes:
measure: Urine 6-β-hydroxycortisol:cortisol ratio
timeFrame: 3 weeks
measure: Adverse event monitoring, physical examinations, sitting vital sign measurements (blood pressure and pulse rate), 12-lead ECGs, laboratory safety assessments.
timeFrame: 8 weeks
measure: PK for CP-945598 and its primary circulating metabolite
timeFrame: 6 weeks
Secondary outcomes:
measure: Breath ID® tests (methacetin and octanoate)
timeFrame: 6 weeks
measure: Soluble and exploratory biomarkers
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Pfizer Investigational Site
state: California
city: Anaheim
country: United States
facility: Pfizer Investigational Site
state: California
city: Durham
country: United States
facility: Pfizer Investigational Site
state: North Carolina
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: