louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00544245: Is Monitoring Activity Important for Short- and Long-term Weight Loss?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Keywords: overweight
obesity
accelerometer
pedometer
energy balance
weight loss
weight maintenance
Lead sponsor: University of Hawaii
Sponsor class: OTHER
Collaborators: name: The Apex Fitness Group
name: Bookman Publishing Company
First posted: 2007-10-16
Enrollment: 83
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This study is comparing the effectiveness of two techniques for monitoring physical activity and energy balance on long-term weight management (two years). The focus is on weight loss, prevention of weight gain, and the maintenance of a healthy weight over time. It is expected that both techniques will benefit long-term weight management.

Detailed description: The major objective of this study is to determine if two techniques for monitoring physical activity and energy balance promote the maintenance of weight loss in healthy overweight and obese individuals. The study compares two approaches designed to help individuals monitor physical activity and to adjust their calorie intake to maintain a reasonable energy balance (bodybugg® \& Step Diet Book systems). Full subject participation in the study spans two years. Participants periodically report to a pre-arranged location to be measured by a qualified fitness professional for height, weight, circumferences, and estimated body fat using a bioelectric impedance scale (body fat scale).

Eligibility criteria: Inclusion Criteria:

* Desire to lose weight
* Height: 60-76 inches
* BMI 27-40
* Healthy

Exclusion Criteria:

* Currently enrolled in a weight loss program
* Currently under medical care for obesity treatment
* Using drug, supplement, or similar treatment to promote weight loss
* Have undergone bariatric surgery or have breast implants
* Intend to have surgery within the next 24 months
* Have had an eating disorder
* Are pregnant, breast-feeding, or plan to become pregnant within 24 months
* Are planning an extended vacation, absence, or relocation within 24 months
* Use tobacco products
* Frequently consume 2 or more alcoholic drinks per day
* Use illegal drugs, steroids, or growth hormone
* Use any appetite-affecting medications
* Are eating a physician-supervised diet
* Have other problems that might interfere with ability to participate

Primary outcomes:
measure: Change in measures of body weight, body circumferences, and estimated body composition
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Honolulu
country: United States
facility: Univ of Hawaii Dept of Human Nutrition, Food & Animal Sci
state: Hawaii
Study officials:
affiliation: Human Nutrition, Food & Animal Sci / Univ of Hawaii
name: Charles A Titchenal, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Human Nutrition, Food & Animal Sci / Univ of Hawaii
name: Joannie C Dobbs, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02772445: Stroke Caregiver Empowerment
Official title: Stroke Caregiver Empowerment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Empowerment
Caregiver
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2016-05-13
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to refine STROKE-CARE for caregivers and explore changes in caregiver and care-recipient outcomes

Detailed description: Individuals with disabilities rely heavily on unpaid family caregivers to help perform necessary occupations. The emotional and physical demands of caregiving often contribute to caregivers experiencing burden. Caregivers with burden are at-risk for poor health and a heightened risk of mortality. This is likely, in turn, to negatively impact care-recipient quality of life. The proposed study refines a behavioral intervention that teaches caregivers to facilitate problem solving over the course of daily activities. The long-term goal for this project is to establish an effective rehabilitation intervention that promotes caregiver health and well-being, which ultimately influences care-recipient health. This study will use an open-case series and a single-arm clinical trial to refine the intervention and examine caregiver and care-recipient response to the intervention. This research applies to the priorities and objectives of this research initiative through examination of a caregiver-centered, standardized intervention that is based on occupational theories and principles, investigating outcomes experienced by caregivers of individuals with cognitive deficits after stroke. Data from this pilot project will be used to design and obtain federal funding for a randomized controlled trial to examine the efficacy of the refined intervention on caregiver and care-recipient health outcomes.

Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Primary caregiver for an individual post-stroke
* Live with the care-recipient
* Provide 1 hour of caregiving per day
* Subjective caregiver burden

Exclusion Criteria:

* non-English speaking
* Active treatment (chemotherapy, radiation therapy) for cancer
* Imminent placement of care-recipient into a nursing home or with another caregiver (within 6 months)
* Involvement in another clinical trial for caregivers

Primary outcomes:
measure: The proportion of caregivers that use the universal strategy in daily activities
timeFrame: after study completion, an average of 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
References:
Clinical trial NCT02479945: Peripheral vs. Selective Tumor Marker Venous Sampling in Prostate Cancer
Official title: Peripheral vs. Selective Tumor Marker Venous Sampling in Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2015-06-24
Enrollment: 6
Sex: MALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The investigators will compare tumor marker levels, including PSA, in samples taken from a peripheral upper limb vein and the internal iliac veins. These will be collected from patients who are scheduled for prostatectomy as part of their standard of care for prostate cancer. A selective internal iliac vein sampling procedure will be performed in Interventional Radiology. Venous samples will be correlated with prostatectomy specimens. The aim is to predict the side of the prostate containing tumor.


Eligibility criteria: Inclusion Criteria:

1. All male patients, age 18 to 99, with biopsy proven prostate adenocarcinoma prior to planned radical prostatectomy.
2. Informed Consent/HIPAA Form discussed and signed by subject.
3. Baseline lab values obtained within 120 days of planned selective venous sampling.

Exclusion Criteria:

1. Skin related problems around the planned venepuncture site (infection, phlebitis, scars)
2. Documented allergy to iodinated contrast or lidocaine.
3. Coagulopathy with an INR of greater than 1.5
4. Thrombocytopenia with platelets less than 25,000 uL
5. Renal insufficiency with a creatinine of 1.5 mg/dL
6. Documented current upper extremity or central venous thrombosis
7. DRE within 4 weeks prior to selective venous sampling
8. Prostate biopsy within 6 weeks prior to selective venous sampling.
9. Patient unable to sign his own consent or does not demonstrate full understanding of the procedure.
10. Patient has known metastatic disease or a known primary cancer other than prostate adenocarcinoma.
11. Patient has already been enrolled in this research study.
12. Life expectancy less than 6 months.

Primary outcomes:
measure: Number of Adverse Events
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: Micah Watts, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01417845: The Effect of Exercise Training Intensity in Patients With Type 2 Diabetes
Official title: The Effect of Moderate Versus High Intensity Exercise Training on Physical Fitness and Physical Function in Patients With Type 2 Diabetes: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: University of Central Arkansas
Sponsor class: OTHER
First posted: 2011-08-16
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this randomized clinical trial is to compare the effect of moderate versus high intensity exercise training on physical fitness and physical function in patients with type 2 diabetes. The research hypothesis is that high intensity exercise training will be superior to moderate intensity on such outcomes in individuals with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* All participants meet the American Diabetes Association diagnostic criteria for type 2 diabetes.
* A physician must consider each participant to be medically stable to participate in this investigation.

Exclusion Criteria:

* Any individual with a history of a medical condition identified by the American Heart Association as an absolute contraindication to exercise testing is excluded from this study.
* Any individual with angina (stable or unstable), uncontrolled hypertension, proliferative retinopathy, severe peripheral neuropathy, nephropathy, autonomic neuropathy, history of coronary artery disease, history of myocardial infarction, or unable to participate in this study due to a physical impairment is excluded from this investigation.
* Any individual involved in resistance training or aerobic training within 3 months of the beginning of this investigation is excluded.

Primary outcomes:
measure: Muscle Strength
timeFrame: Baseline and 3 months thereafter
measure: Physical Function
timeFrame: Baseline and 3 months thereafter
measure: Exercise Capacity
timeFrame: Baseline and 3 months thereafter
Secondary outcomes:
Other outcomes:
Locations:
city: Conway
country: United States
facility: University of Central Arkansas
state: Arkansas
Study officials:
affiliation: University of Central Arkansas
name: James D Taylor, PhD, PT
role: PRINCIPAL_INVESTIGATOR
References:
citation: Taylor JD, Fletcher JP, Mathis RA, Cade WT. Effects of moderate- versus high-intensity exercise training on physical fitness and physical function in people with type 2 diabetes: a randomized clinical trial. Phys Ther. 2014 Dec;94(12):1720-30. doi: 10.2522/ptj.20140097. Epub 2014 Jul 31.
Clinical trial NCT06066645: Travoprost Intraocular Implant + iStent Infinite vs. iStent Infinite Alone
Official title: Multicenter, Randomized, Double-masked Trial to Evaluate the Safety and Efficacy of iDose® TR (Travoprost Intraocular Implant) in Conjunction With the Placement of iStent Infinite vs. iStent Infinite Alone in Subjects With Open-angle Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Glaucoma, Open-Angle
Lead sponsor: Glaukos Corporation
Sponsor class: INDUSTRY
First posted: 2023-10-04
Enrollment: 150
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: Adult subjects with elevated intraocular pressure who have successfully undergone placement of iStent infinite trabecular bypass system will be randomized to receive a travoprost intraocular implant or receive a sham procedure and be followed for 12 months.


Eligibility criteria: Inclusion Criteria:

* diagnosis of open-angle glaucoma or ocular hypertension
* qualifying IOP in the study eye

Exclusion Criteria:

* unmedicated (washed out) IOP of \>36 mmHg in the study eye
* hypersensitivity to travoprost or any other components of the travoprost intraocular implant
* vertical cup/disc ratio \> 0.8 in the study eye
* best spectacle corrected visual acuity of worse than 20/80 in either eye eye
* any ocular disease or condition that, in the opinion of the investigator, may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study

Primary outcomes:
measure: change from baseline in mean diurnal intraocular pressure (IOP)
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Colorado Springs
country: United States
facility: Glaukos Clinical Study Site
state: Colorado
Study officials:
affiliation: Glaukos Corporation
name: Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01075945: Dihydroartemisinin- Piperaquine Versus Artemether- Lumefantrine in the Treatment Uncomplicated Plasmodium Falciparum Malaria in Sudan
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Malaria
Keywords: antimalarials
ACTs
Piperaquine
uncomplicated
Lead sponsor: University of Khartoum
Sponsor class: OTHER
Collaborators: name: Southeast University, China
First posted: 2010-02-25
Enrollment: 140
Sex: ALL
Minimum age (years): 5
Maximum age (years): 95
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Dihydroartemisinin- Piperaquine is not inferior to artemether-lumefantrine


Eligibility criteria: Inclusion Criteria:

* Uncomplicated malaria

Exclusion Criteria:

* Severe cases
* Pregnancy

Primary outcomes:
measure: comparing the cure rate between the two drugs
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cinnar
country: Sudan
facility: Sinnar
state: Blue Nile
Study officials:
References:
citation: Adam I, Elmardi KA, Malik EM. Predictors of antimalarial treatment failure in an area of unstable malaria transmission in eastern Sudan. Trans R Soc Trop Med Hyg. 2009 Jan;103(1):21-4. doi: 10.1016/j.trstmh.2008.07.005. Epub 2008 Aug 20.
Clinical trial NCT04294745: Comparing Buccal Infiltration and Inferior Alveolar Nerve Block for Extraction of Mandibular Teeth
Official title: Effectiveness of Buccal Infiltration and Inferior Alveolar Nerve Block With Articaine for Extraction of Mandibular Teeth- A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Buccal Infiltration Inferior Alveolar Nerve Block Articaine
Keywords: Buccal infiltration inferior alveolar nerve block Articaine
Lead sponsor: Melaka Manipal Medical College
Sponsor class: OTHER
First posted: 2020-03-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study compares the effectiveness of two techniques of local anesthesia in the extraction of mandibular teeth. One group received inferior alveolar nerve block and the other group received buccal infiltration of 4% Articaine

Detailed description: Inferior alveolar nerve block is the commonly used local anesthetic injection technique for extraction of mandibular teeth. Buccal infiltration technique alone is considered to be ineffective in treating mandibular teeth due to the thickness of buccal cortical plate. However, buccal infiltration, if provided with an agent with higher penetration capability, may be used instead of Inferior alveolar nerve block. Articaine, due to its thiophene ring, has higher liposolubility and bony diffusion than any other agent.

This study compares the effectiveness of inferior alveolar nerve block and buccal infiltration using 4% Articaine in the extraction of mandibular teeth

Eligibility criteria: Inclusion Criteria:

* Mandibular teeth
* grossly decayed teeth
* root stumps
* therapeutic extractions
* American society of anesthesiologist classification I \& II patients

Exclusion Criteria:

* patients allergic to local anesthesia
* infected teeth
* grade 2 and grade 3 mobile teeth
* patients already taking medications which influences the anaesthetic assessment

Primary outcomes:
measure: Pain during injection using a visual analogue scale measuring 10 cm with 0 depicting no pain and 10 depicting severe pain
timeFrame: During injection
measure: Pain during extraction using a visual analogue scale measuring 10 cm with 0 depicting no pain and 10 depicting severe pain
timeFrame: During extraction
measure: Requirement of rescue injection
timeFrame: During extraction
Secondary outcomes:
Other outcomes:
Locations:
city: Melaka
country: Malaysia
facility: Melaka Manipal Medical College
Study officials:
affiliation: Melaka Manipal Medical College
name: Abdul R Ismail
role: STUDY_DIRECTOR
References:
Clinical trial NCT01816945: The Momba Mobile Application-based Community
Official title: The Momba Mobile Application-based Community
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Health Wellness 1
Keywords: Depression
Stress
Social support
Social capital
Maternal
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2013-03-22
Enrollment: 47
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The investigators' mobile application-based community, termed Momba, will provide a bi-directional flow of information on maternal and infant mental health to traditionally underrepresented groups of mothers and their infants. The overall goal of this mobile application-based community of low-income postpartum women and infants is to increase the social support, social networks, and social capital of low-income mothers; thereby, leading to a positive change in the health behaviors, utilization of health services, and mental health status of both mothers and their infants.


Eligibility criteria: Inclusion Criteria:

* Women will be recruited in their third trimester of pregnancy from Yale-New Haven Hospital (YNHH) and followed for 8 months postpartum.
* Women are eligible if they are over the age of 18, in their third trimester of pregnancy, will deliver a baby at YNHH and receive prenatal care at the Women's Center.
* Meet criteria for minor or major depressive disorder.

Exclusion Criteria:

* Mothers are not eligible to participate if they have previously given birth
* Are placing the baby for adoption
* Are planning to move in the next 18 months
* Are actively suicidal, psychotic or unable to provide informed consent

Primary outcomes:
measure: Phone Retention
timeFrame: 15 months
measure: Test the Proper Operating and Functioning of the MOMBA Application
timeFrame: Baseline
Secondary outcomes:
measure: Acceptability and Performance of Structured Questionnaires
timeFrame: 12 months
Other outcomes:
measure: Patient Health
timeFrame: 12 months
measure: Confident Network Score
timeFrame: 12 months
Locations:
city: New Haven
country: United States
facility: Yale School of Medicine
state: Connecticut
Study officials:
affiliation: Yale University
name: Megan V Smith, DrPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01764347: Magnetic Resonance Imaging-Transrectal Ultrasound Fusion Image-Guided Prostate Biopsy Following Radical Prostatectomy in Patients With Prostate Cancer
Official title: Accuracy of Targeted Biopsies Using MRI-TRUS Fusion Guidance: Pilot Study on Ex Vivo Radical Prostatectomy Specimens
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2013-01-09
Enrollment: 24
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This pilot clinical trial studies magnetic resonance imaging (MRI)-transrectal ultrasound (TRUS) fusion image-guided prostate biopsy following radical prostatectomy in patients with prostate cancer. Diagnostic procedures, such as MRI-TRUS fusion image-guided prostate biopsy may help find and diagnose prostate cancer

Detailed description: PRIMARY OBJECTIVES:

I. To evaluate accuracy of the new image-guided targeted needle biopsy using the ex-vivo human prostate as obtained from fresh radical prostatectomy specimens.

OUTLINE: Patients undergo robotic radical prostatectomy, followed by 3 MRI-TRUS fusion image-guided prostate biopsies.

Eligibility criteria: Inclusion Criteria:

* Subjects must have biopsy-proven prostate cancer, or prostate-specific antigen (PSA) \>= 4 ng/ml or an abnormal digital rectal examination (DRE) if consented before prostate biopsy
* Subjects must have at least 2, preferably 3, pre-operative magnetic resonance imaging (MRI)-identified malignant or benign lesions that measure between 10 mm and 15 mm in diameter within the prostate
* Subjects must have decided to have their prostate surgically removed

Exclusion Criteria:

* Patients who do not give informed consent
* Patients with extracapsular extension of their prostate cancer

Primary outcomes:
measure: Number of times the first biopsy needle is placed within 3.0 mm of the center lesion
timeFrame: One month after last patient enrolled is taken off study
measure: Number of times the second biopsy needle is placed within 3.0 mm of the center lesion
timeFrame: One month after last patient enrolled is take off study
Secondary outcomes:
measure: Average distance of the first needle to the center of the lesion
timeFrame: One month after last patient enrolled is taken off study
measure: Average distance of the second needle from the first needle minus 2.0 mm
timeFrame: One month after last patient enrolled is taken off study
measure: Average distance of the third needle from the first needle minus 2.0 mm
timeFrame: One month after last patient enrolled is taken off study
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC Norris Comprehensive Cancer Center
state: California
Study officials:
affiliation: University of Southern California
name: Osamu Ukimura
role: PRINCIPAL_INVESTIGATOR
References: