louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00002218: A Phase I Maximum Tolerated Dose Study of CI-1012 in Late-Stage HIV+ Patients
Official title: A Phase I Maximum Tolerated Dose Study of CI-1012 in Late-Stage HIV+ Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infections
Keywords: HIV-1
Dose-Response Relationship, Drug
Anti-HIV Agents
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: To determine the maximum tolerated dose of CI-1012 in late-stage HIV-1-infected patients. To determine the antiretroviral activity of CI-1012 when added to combination therapy. To assess the multiple-dose pharmacokinetic characteristics of CT-1012 when added to combination therapy. To assess the effect of CI-1012 on the pharmacokinetics of other antiretroviral agents.

Detailed description: Doses are escalated based on safety assessments: As soon as a dose meets the criteria for "tolerated" or "not tolerated", doses are escalated or terminated, respectively. All patients are treated for 2 weeks, with follow-up visits scheduled 1 week and 1 month post-treatment.

Eligibility criteria: Inclusion Criteria

Patients must have:

* Serological evidence of late-stage HIV-1 infection (ELISA and Western Blot).
* CD4 T cell count less than or equal to 200 mm3.
* HIV-1 RNA greater than or equal to 5,000 copies/mL.

Exclusion Criteria

Prior Medication:

Excluded:

* Anti-HIV treatment within 8 weeks prior to entry.
* Systemic steroids within 4 weeks prior to entry.

Prior Treatment:

Excluded:

Treatment with anticancer agents within 4 weeks prior to study.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Palm Springs
country: United States
facility: ViRx Inc
state: California
city: San Francisco
country: United States
facility: ViRx Inc
state: California
city: Maitland
country: United States
facility: Central Florida Research Initiative
state: Florida
city: Bethesda
country: United States
facility: Natl Institutes of Health
state: Maryland
city: Ann Arbor
country: United States
facility: Univ of Michigan
state: Michigan
city: Salt Lake City
country: United States
facility: Univ of Utah Med School / Clinical Trials Ctr
state: Utah
Study officials:
References:
Clinical trial NCT02774018: Life Satisfaction and Psychopathology in Institutionalized Elderly People
Official title: Life Satisfaction and Psychopathology in Institutionalized Elderly People: The Results of an Adapted Mindfulness-Based Stress Reduction Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Depression (Mild or Not Persistent)
Keywords: Mindfulness
Elderly
Psychopathology
Lead sponsor: Irmandade da Misericórdia de Albergaria-a-Velha
Sponsor class: OTHER
First posted: 2016-05-16
Enrollment: 12
Sex: ALL
Minimum age (years): 65
Maximum age (years): 95
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The present study attempted to test the benefits of a Mindfulness-Based Stress Reduction (MBSR) program in Portuguese institutionalized elderly people, as a way to improve life satisfaction and reduce psychopathology. The sample included 12 institutionalized elderly people, with ages between 65 and 91 (M = 82.58 years; SD = 7.87), that filled several selfreport questionnaires and were assessed with Mini Mental State Examination. Participants attended to an adapted Mindfulness-Based Stress Reduction program (KabatZinn,1994), with 48 sessions (16 weeks) and Participants were evaluated before and after the intervention.


Eligibility criteria: Inclusion Criteria:

* literacy
* age above 65 years

Exclusion Criteria:

* presence of cognitive or sensorial
* impairment

Primary outcomes:
measure: Change in depression levels assessed with the GDS
timeFrame: Pre-test and Post-test (4 months later)
measure: Change in anxiety levels assessed with the DASS-21
timeFrame: Pre-test and Post-test (4 months later)
measure: Change in experiential avoidance levels assessed with the AAQ-II
timeFrame: Pre-test and Post-test (4 months later)
measure: Change in subjective pain levels assessed with the Faces Scale
timeFrame: Pre-test and Post-test (4 months later)
measure: Change in life satisfaction levels assessed with the SWLS
timeFrame: Pre-test and Post-test (4 months later)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02481518: Preloading Magnesium Attenuate Cisplatin-induced Nephrotoxicity
Official title: Preloading Magnesium Attenuate Cisplatin-induced Nephrotoxicity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Kidney Injury
Keywords: Cisplatin nephrotoxicity
Acute kidney injury
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2015-06-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether magnesium preloading reduce incident of cisplatin induced acute kidney injury in head and neck cancer who receiving low dose cisplatin (40 mg/m2 weekly for 7 weeks).

Detailed description: Randomized controlled trial comparing efficacy of magnesium preloading versus normal saline for prevention of acute and chronic nephrotoxicity of cisplatin.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Eastern Cooperative Oncology Group score 0-2
* First Diagnosed Head and neck cancer and plan for treatment with cisplatin
* Serum creatinine ≤1.5 mg/dl or eGFR≥60(ml/min/1.73 m2)

Exclusion Criteria:

* Prior treatment with cisplatin before randomization
* Uncontrolled concurrent disease
* Pregnancy

Primary outcomes:
measure: Acute kidney injury
timeFrame: 7 days after cisplatin administration
Secondary outcomes:
measure: Nephrotoxicity
timeFrame: up to 12 weeks
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Faculty of medicine, Ramathibodi Hospital, Mahidol University
Study officials:
affiliation: Ramathibodi hospital, Mahidol university
name: Arkom Nongnuch, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01375218: Efficacy and Satisfaction Comparing Two Braces in the Treatment of Developmental Dysplasia of the Hip (DDH) in Infants
Official title: Efficacy and Satisfaction Comparing Two Braces in the Treatment of DDH in Infants: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hip Dislocation, Congenital
Congenital Deformity of Hip Joint
Lead sponsor: OrthoCarolina Research Institute, Inc.
Sponsor class: OTHER
First posted: 2011-06-17
Enrollment: 30
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to 1) evaluate the effectiveness of the Plastizote abduction brace compared to the Pavlik harness in the treatment of developmental dysplasia of the hip (DDH) and 2) compare parent/caregiver satisfaction between the Plastizote abduction brace and the Pavlik harness. The investigators hope to learn which brace treatment is best for a definable population so the appropriate brace can be chosen initially avoiding the time, expense, and frustration of a failed technique.


Eligibility criteria: Inclusion Criteria:

1. 0-2 months of age
2. Nonterratological developmental dysplasia of the hip diagnosed by physical exam and standard of care ultrasound

Exclusion Criteria:

1. Ages greater than 2 months
2. Neurological condition
3. Terratological congenital dysplasia of the hip diagnosed by physical exam and standard of care ultrasound
4. Chromosomal abnormality

Primary outcomes:
measure: Resolution of instability
timeFrame: 3-4 week interval
Secondary outcomes:
measure: Resolution of instability
timeFrame: 6 month interval
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: OrthoCarolina Research Institute, OrthoCarolina, P.A.
state: North Carolina
Study officials:
References:
citation: Dwan K, Kirkham J, Paton RW, Morley E, Newton AW, Perry DC. Splinting for the non-operative management of developmental dysplasia of the hip (DDH) in children under six months of age. Cochrane Database Syst Rev. 2022 Oct 10;10(10):CD012717. doi: 10.1002/14651858.CD012717.pub2.
Clinical trial NCT03290118: The Efficacy of Front-of-package Labelling Schemes: an Experimental Study
Official title: The Efficacy of Front-of-package Labelling Schemes: an Experimental Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diet Modification
Cardiovascular Diseases
Nutrition
Lead sponsor: University of Toronto
Sponsor class: OTHER
First posted: 2017-09-21
Enrollment: 2008
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is an online study that aims to test the effectiveness of Interpretative Nutrition Rating Systems (INRS) such as the Health Star Rating System (HSR or Star System), traffic light system and warning labels (high sodium, saturated fat and sugar) proposed by Health Canada. The study will incorporate the use of a Smartphone application (app), FoodFlip®, to help educate consumers on each INRS prior to their exposure on food packages.


Eligibility criteria: Inclusion Criteria:

* speak English as a primary language
* reside in Canada excluding the Northern Territories
* are 18 years or over
* provide informed consent
* do at least some of the household grocery shopping
* own a smartphone (version iPhone 3 or later or Android)
* are able to complete the survey on a minimum screen size of 9.7 inches.

Primary outcomes:
measure: Comprehension task - ability to identify healthy products (survey measure)
timeFrame: 1 day (assessed immediately after app task and while viewing products with labelling system applied
measure: Comprehension task - ability to identify unhealthy products (survey measure)
timeFrame: 1 day (assessed immediately after app task and while viewing products with labelling system applied
Secondary outcomes:
measure: Comprehension task - ability to identify the overall 'healthiness' of a product (survey measure - Likert scale)
timeFrame: 1 day (assessed immediately after app task and while viewing products with labelling system applied
measure: Hypothetical purchasing of products (survey measure - Likert scale)
timeFrame: 1 day (assessed immediately after app task and while viewing products with labelling system applied
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University of Toronto
state: Ontario
Study officials:
References:
citation: Vanderlee L, Franco-Arellano B, Ahmed M, Oh A, Lou W, L'Abbe MR. The efficacy of 'high in' warning labels, health star and traffic light front-of-package labelling: an online randomised control trial. Public Health Nutr. 2021 Jan;24(1):62-74. doi: 10.1017/S1368980020003213. Epub 2020 Oct 6.
citation: Ahmed M, Oh A, Vanderlee L, Franco-Arellano B, Schermel A, Lou W, L'Abbe MR. A randomized controlled trial examining consumers' perceptions and opinions on using different versions of a FoodFlip(c) smartphone application for delivery of nutrition information. Int J Behav Nutr Phys Act. 2020 Feb 12;17(1):22. doi: 10.1186/s12966-020-0923-1.
Clinical trial NCT00248118: Efficacy and Safety of Bupropion for Treatment of Adolescent Smoking
Official title: Neurocognitive and Affective Correlates of Tobacco Dependence in Adolescent Smokers and Efficacy and Safety of Bupropion for Treatment of Adolescent Smoking
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Tobacco Dependence
Keywords: Randomized
Double-blind
Placebo-controlled
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2005-11-03
Enrollment: 72
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine: 1) the short-term clinical efficacy and safety of bupropion for helping adolescent tobacco smokers quit, and 2) The role of withdrawal symptoms in the maintenance of smoking in adolescents.

Detailed description: This 10-week study consists of an unassisted (pretrial) acute tobacco withdrawal (AW) phase and a 7-week randomized double-blind placebo-controlled trial of bupropion (300 mg/day) for tobacco dependence. Neuropsychological examinations will be conducted at baseline, during acute withdrawal, and during treatment (incl. early withdrawal) with bupropion. We expect smoking cessation in approximately 25% of the active medication group and significant overall smoking reduction. We postulate that bupropion will also reduce the irritability, depressed mood and anxiety symptoms that typically occur during tobacco withdrawal. We expect to observe optimal cognitive performance, (i.e., attention, memory), and affective state during satiety, impairment during pre-treatment abstinence, and intermediate level cognitive performance in the abstinent active-treatment group. Because limited data are available on cognitive tasks in adolescent smokers, a non-smoking group will be included in order to establish the validity and appropriateness of our paradigm with a normative sample.

Eligibility criteria: Inclusion Criteria:

* More than 100 lbs
* IQ greater than 80
* General good health
* Not pregnant
* Non-Smoker: No cigarettes in last 6 months, less than 5 in lifetime
* Smokers: Smoke more than 6 cigarettes per day for at least 6 months

Exclusion Criteria:

* Cardiac, Central Nervous System (CNS) or severe psychiatric disorder
* Psychoactive medications (including nicotine replacement)
* Substance use disorder

Primary outcomes:
measure: Bupropion will be safe and tolerable, increase cessation rates, and reduce smoke and nicotine exposure
timeFrame: 7 weeks
Secondary outcomes:
measure: Reduction of smoking-related urges and cravings.
timeFrame: 7 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Teen Tobacco Addiction Research Clinic, NIDA Intramural Research Program
state: Maryland
Study officials:
affiliation: National Institute on Drug Abuse, Intramural Research Program
name: Eric T. Moolchan, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01964118: Can Intermittent Fasting Mimic the Metabolic and Cardiovascular and Anti-aging Effects of Calorie Restriction?
Official title: Can Intermittent Fasting Mimic the Metabolic and Cardiovascular and Anti-aging Effects of Calorie Restriction?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Overweight
Keywords: intermittent fasting
obesity
calorie restriction
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2013-10-17
Enrollment: 50
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of Intermittent Fasting study is to investigate whether intermittent fasting could decrease the chronic inflammation levels in overweight/obese people.

Detailed description: The primary objective of this study is to determine whether or not IF reduces the level of chronic inflammation as evidenced by a decrease in high sensitive C-reactive protein (hsCRP), as the main outcome measure

Eligibility criteria: Inclusion Criteria:

* The participants in this study will be 50 men and women in the 30 to 65 year age range, who have a BMI in the high normal to moderately obese range (i.e. 24 to 35 kg/m2),
* Participants who are eating usual US diets and are sedentary to moderately active (i.e. not exercise trained).

Exclusion Criteria:

* History of any chronic disease process that could interfere with interpretation of results
* Smoking, pregnancy, alcoholism, psychiatric problems, life situations that would interfere with study participation and compliance.

Primary outcomes:
measure: Change in HSCRP ( high sensitivity C-reactive protein) at 6 and 12 months
timeFrame: Every 6 months- baseline, 6 month and 12 month
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Valeria Tosti, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Washington University School of Medicine
name: Luigi Fontana, MD, Phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: Goodrick CL, Ingram DK, Reynolds MA, Freeman JR, Cider NL. Effects of intermittent feeding upon growth and life span in rats. Gerontology. 1982;28(4):233-41. doi: 10.1159/000212538.
citation: Allaf M, Elghazaly H, Mohamed OG, Fareen MFK, Zaman S, Salmasi AM, Tsilidis K, Dehghan A. Intermittent fasting for the prevention of cardiovascular disease. Cochrane Database Syst Rev. 2021 Jan 29;1(1):CD013496. doi: 10.1002/14651858.CD013496.pub2.
Clinical trial NCT06745518: A Phase 2 Study of TS-172 in Hyperphosphatemia Patients on Hemodialysis With Phosphate Binders
Official title: A Phase 2, Randomized, Placebo-controlled, Double-blind, Phosphate Binder-combination Study of TS-172 in Hyperphosphatemia Patients on Hemodialysis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Hyperphosphatemia Patients on Hemodialysis
Lead sponsor: Taisho Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-12-20
Enrollment: 62
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: A phase 2, randomized, placebo-controlled, double-blind, phosphate binder-combination study of TS-172 in hyperphosphatemia patients on hemodialysis


Eligibility criteria: Inclusion Criteria:

1. Hyperphosphatemia patients (outpatients) with chronic kidney disease receiving hemodialysis (HD or HDF) 3 times a week for at least 12 weeks prior to Visit 1 (Week -3)
2. Patients aged \>= 18 years at the time of obtaining informed consent
3. Patients with a serum phosphorus concentration of \>= 5.5 mg/dL and \< 10.0 mg/dL at Visit 1 (Week -3)
4. Patients who have been prescribed at least one phosphate binder within the approved dosage, and the prescribed drug and dosage regimen should have been unchanged during the last 2 weeks prior to Visit 1 (Week -3)

Exclusion Criteria:

1. Patients with confirmed serum intact PTH concentration \>500 pg/mL from Visit 1 (Week -3) to Visit 4 (Week 0)
2. Patients who have undergone previous parathyroid intervention (PTx, PEIT, etc.)

Primary outcomes:
measure: Achievement rate of the target serum phosphorus level
timeFrame: Week 8
Secondary outcomes:
measure: Change from baseline in serum concentration of phosphorus
timeFrame: Up to Week 8
measure: Concentration of corrected serum calcium
timeFrame: Up to Week 8
measure: Serum Ca × P product
timeFrame: Up to Week 8
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Taisho Pharmaceutical Co., Ltd selected site
Study officials:
affiliation: Taisho Pharmaceutical Co., Ltd.
name: Taisho Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00011518: Bladder Cancer Case Control Study of Arsenic in Water
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bladder Cancer
Keywords: Arsenic
Bladder Cancer
Drinking Water
Lead sponsor: National Institute of Environmental Health Sciences (NIEHS)
Sponsor class: NIH
First posted: 2001-02-26
Enrollment: 600
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE

Brief summary: This study is examining the relationship between ingested arsenic and bladder cancer in two areas of California where a large percentage of the population was exposed to drinking water containing arsenic at low to moderate levels.

Detailed description: Water supplies in many parts of the world contain naturally occurring arsenic. Previous studies have shown that arsenic at high doses can cause cancer of the bladder. The risk at lower doses is unknown. This study is examining the relationship between ingested arsenic and bladder cancer in central Nevada and Kings County, California, two areas where a large percentage of the population was exposed to drinking water containing arsenic at low to moderate levels. Approximately 200 people with bladder cancer and 400 people without bladder cancer will be included. Subjects are interviewed by telephone about past residences, occupations, diet, drinking water consumption, and other lifestyle factors. Arsenic measurements in well water have been collected from the appropriate state agencies and are being matched with residences and drinking water consumption rates to estimate lifetime arsenic exposures for each subject. People with bladder cancer will then be compared to those without to see if people with cancer were more likely to have lived in areas with arsenic in their drinking water.

Eligibility criteria: Cases must meet the following criteria:

* Diagnosed with primary bladder cancer from January 1, 1997 until December 31, 2000.
* Live in the following counties at the time of diagnosis: Churchill, Lyon, Mineral, Storey, Douglas, Carson City, Nevada, and Kings County, California
* Ages 20-85 at the time of diagnosis.

Controls will be matched to cases based on gender and five year age groups.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Berkeley
country: United States
facility: Allan Smith Research Office
state: California
Study officials:
References: