louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01334567: Rollover Protocol Continued Access to Tenofovir Disoproxil Fumarate (TDF) for Subjects in Taiwan
Official title: A Rollover Protocol to Provide Subjects From Taiwan Continued Access to Tenofovir Disoproxil Fumarate After Completing Study GS-US-174-0108
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis B
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2011-04-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to offer subjects from centers in Taiwan who successfully complete 168 weeks of treatment in study GS US 174-0108 access to treatment with tenofovir DF for up to three additional years (144 weeks). Subjects will be followed per local standard of care. Serious adverse events (SAEs), drug accountability and patient disposition will be recorded.


Eligibility criteria: Inclusion Criteria:

Subjects must meet all of the following inclusion criteria to be eligible for participation in this study.

* Complete all end of study visit procedures for the GS US 174-0108 study.
* Willing and able to provide written informed consent.
* A negative pregnancy test is required for female subjects at the end of study visit (i.e., screening visit for study GS-US-174-0141) for GS US 174-0108 (unless surgically sterile or greater than two years post-menopausal)
* All sexually active female subjects who are not post menopausal, or surgically sterile and are of childbearing potential must agree to use a highly effective method of contraception during heterosexual intercourse throughout the study.
* Male subjects who are sexually active are required to use barrier contraception (condom with spermicide) during heterosexual intercourse through to study completion.

Exclusion Criteria:

• Not Applicable

Primary outcomes:
measure: No statistical analyses are planned. Listings will include subject enrollment, subject disposition and SAEs.
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Kaoshiung Hsien
country: Taiwan
city: Tainan
country: Taiwan
city: Taipei
country: Taiwan
city: Taoyuan Hsien
country: Taiwan
Study officials:
affiliation: Gilead Sciences
name: John Flaherty, PharmD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06910267: Leveraging Adult Protective Service Interaction to Offer Evidence-Based Treatment for Depression in Elder Neglect/Self Neglect
Official title: Leveraging Adult Protective Service Interaction to Offer Evidence-Based Treatment for Depression in Elder Neglect/Self Neglect
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Depression in Old Age
Keywords: Elder neglect
Self neglect
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2025-04-04
Enrollment: 50
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test the feasibility and acceptability of an evidence-based treatment for depression delivered over an ipad, computer, or smartphone can help Adult Protective Services (APS) clients with their activities of daily living to evaluate whether reductions on measures of depression and apathy (a) mediate reduced Elder Neglect/Self Neglect (EN/SN) behaviors; and (b) whether secondary posited mediating mechanisms are also active in impacting depression and apathy


Eligibility criteria: Inclusion Criteria:

* APS Case in APS Region VI- Must have open case
* PHQ 9 score- Must have score of nine (9) or more

Exclusion Criteria:

* Previous mental health diagnosis of bipolar disorder, psychotic disorders, and moderate to severe dementia
* Assessment of Consent Proxy- Those who need assessment of consent proxy
* Suicidal Intent (as indexed by PhQ-9 question 9)- Those scoring 2 or 3
* Current Alcohol and Drug Dependency- As evidenced by Cut down, Annoyed, Guilty, and Eye-opener (CAGE) score of 3 or more

Primary outcomes:
measure: Change in depression as assessed by the Patient Depression Questionnaire (PHQ-9)
timeFrame: baseline, post-treatment ( 8 weeks after baseline), and 3 months
measure: Change in apathy as assessed by the Apathy Motivations Index (AMI)
timeFrame: baseline, post-treatment ( 8 weeks after baseline), and 3 months
measure: Change in Elder Neglect/Self Neglect (EN/SN) as evidenced by study developed goal attainment scale
timeFrame: baseline, post-treatment ( 8 weeks after baseline), and 3 months
Secondary outcomes:
measure: Change in social connection as assessed by the Lubben Social Network Scale
timeFrame: baseline, post-treatment ( 8 weeks after baseline), and 3 months
measure: Change in social isolation as assessed by Patient-Reported Outcomes Measurement Information System (PROMIS 8)
timeFrame: baseline, post-treatment ( 8 weeks after baseline), and 3 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Leila Wood, PhD, MSSW
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06099067: Harmonizing RCT-Duplicate Emulations In A Real World Replication Program (HARRP)
Official title: Harmonizing RCT-Duplicate Emulations: A Real World Replication Program Analyzing Three Clinical Trials, CANVAS, LEADER, and SAVOR TIMI in Type 2 Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes Mellitus
Keywords: Clinical Trial
Emulation
Epidemiology
Type 2 Diabetes
Regulatory
Real World Evidence
Real World Data
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2023-10-25
Enrollment: 239990
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Type 2 diabetes mellitus (T2DM) adult patients enrolled in the two claims databases and are eligible to be included according to the inclusion and exclusion criteria of each of the three investigated clinical trial studies: CANVAS, LEADER and SAVOR-TIMI.

All subjects meeting the inclusion and exclusion criteria will be assessed. Remaining sample size will be dependent on the number of matched subjects in each cohort using the two data sources combined.

Brief summary: Replication of three clinical trial emulations CANVAS, LEADER, and SAVOR TIMI that form part of the RCT-Duplicate initiative, sponsored by the FDA and delivered by the Brigham and Women's Hospital and Harvard Medical School. AstraZeneca will use the Instant Health Data platform PANALGOS (IHD) for the analyses.

Detailed description: RCT-duplicate (RCT-D) is an initiative led by the Brigham and Women's Hospital and Harvard Medical School, that selected 30 clinical trials as part of an empirical experiment where these trials would be emulated using RWD. AstraZeneca will replicate three emulations CANVAS, LEADER, and SAVOR TIMI from among the 30 plus clinical trials analyzed in RCT-D. These clinical trials assess type 2 diabetes mellitus drugs. The replications will be conducted on the Instant Health Data PANALGOS (IHD) platform to assess these studies in two claims databases Optum and IBM Watson Market Scan. The aim is to recreate these three emulations to investigate the reproducibility of the emulations, increase transparency and better understand the process of trial emulations; and where possible, contribute with potential improvements to the RCT-D framework.

Eligibility criteria: The Eligibility Criteria for CANVAS, LEADER and SAVOR-TIMI are replicated

Please see the Criteria for each under:

* CANVAS: https://clinicaltrials.gov/ct2/show/NCT03936010
* LEADER: https://clinicaltrials.gov/ct2/show/NCT03936049
* SAVOR-TIMI: https://clinicaltrials.gov/ct2/show/NCT03936023

Primary outcomes:
measure: 3-point MACE
timeFrame: Follow up begins the day after drug initiation for the three investigated studies [a median of 134-167 days]
Secondary outcomes:
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Research Site
Study officials:
References:
Clinical trial NCT03669367: EFFECTS OF ABATACEPT on the Progression to Rheumatoid Arthritis(PALABA Study)
Official title: EFFECTS OF ABATACEPT ON THE PROGRESSION TO RHEUMATOID ARTHRITIS IN PATIENTS WITH PALINDROMIC RHEUMATISM (PALABA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Palindromic Rheumatism, Wrist
Lead sponsor: Fundacion Clinic per a la Recerca Biomédica
Sponsor class: OTHER
First posted: 2018-09-13
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: National multi-center study, open, controlled and randomized
Primary purpose: TREATMENT

Brief summary: The main objective of this trial is to test the hypothesis that abatacept can reduce the progression of rheumatoid arthritis in ACPA+ or RF+ patients with palindromic rheumatism compared with patients treated with hydroxychloroquine.

Detailed description: The main objective of this trial is to test the hypothesis that abatacept can reduce the progression of rheumatoid arthritis in ACPA+ or RF+ patients with palindromic rheumatism compared with patients treated with hydroxychloroquine.

Eligibility criteria: Inclusion Criteria:

* Patients with PR according to Guerne and Weissman modified criteria (18) and with:
* Disease evolution \> 3 months and \< 24 months.
* ACPA positivity proven by ELISA test or chemiluminescence (CCP2) and/or Rheumatoid factor positivity (ELISA, nephelometry or chemiluminescence).
* Greater than 18 years of age.

Exclusion Criteria:

* Persistent arthritis: (involvement in one or more joints \> 1 week).
* Criteria of other rheumatic diseases (RA, SLE, etc.).
* Evidence of radiographic damage (join erosions).
* Absence of ACPA or RF.
* Contraindication or intolerance to study drugs (abatacept or hydroxychloroquine).
* Steroid treatment one month before study entry.
* Previous antitrheumatic therapy with synthetic DMARDS (methotrexate, leflunomide, sulfasalazine, cyclosporine, antimalarials.) or biological DMARDs.
* Pregnant women or who want to be pregnant during the study.

Primary outcomes:
measure: The main objective of this trial is to test abatacept efficacy
timeFrame: At any time during the follow-up (up to 24 months)
Secondary outcomes:
measure: Number of participants with treatment-related adverse events as asesed
timeFrame: At any time during the follow-up (up to 24 months)
measure: number of participants with titles positives on serum ACPA.(anti-CarP antibodies)
timeFrame: At any time during the follow-up (up to 24 months)
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial de Barcelona
Study officials:
References:
Clinical trial NCT02650167: Impact of Oropharyngeal Administration of Colostrum in the First 48 Hours of Life Term Premature Newborn ≤ 32 Weeks of Amenorrhea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant, Premature
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2016-01-08
Enrollment: 140
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Colostrum is the first milk secreted by the mother when the tight junctions of mammary epithelium open, allowing the cellular transport of a multitude of components and immunological protective derivatives of the maternal circulation to the milk, and especially immunoglobulins A type. Colostrum is not given to preterm neonates. The assumption behind this work is that the oro pharyngeal administration of colostrum early in preterm infants could help deliver an oral immunotherapy even before the installation of enteral nutrition, through interactions with lymphoid tissues of the oropharynx and the gastrointestinal tract. This practice would improve the digestive tolerance and the establishment of enteral feeding, the decrease in mucosal inflammatory phenomena, but also to provide any protection against subsequent infections. Finally, there could be an improvement in the secondary immune tolerance with a decrease in the occurrence of allergic phenomena.


Eligibility criteria: Inclusion Criteria:

* New premature infant with a term weight ≤ 32 weeks amenorrhea at Nice University Hospital
* Mother seronegative for HIV

Exclusion Criteria:

* Neonates with congenital pathologies immediate prenatal or neonatal diagnosis will not be included.
* Therapy of the mother incompatible with breastfeeding during pregnancy

Primary outcomes:
measure: Measuring caloric intake (number of days required for the calorie intake)
timeFrame: 2 days
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice
Study officials:
affiliation: Centre Hospitalier Universitaire de Nice
name: Stéphanie DE SMET, Dr
role: STUDY_DIRECTOR
References:
Clinical trial NCT03514667: The Effects of Nanocurcumin on Serum Oxidative Stress,Inflammation,Adiponectin and NF-kB in Blood Mononuclear Cells in Metabolic Syndrome Patients (Nuclear Factor-κB)
Official title: The Effects of Nanomicielle Curcumin on Oxidative Stress, Systemic Inflammation, Adiponectin in Serum and NF-kB in Blood Mononuclear Cells, in Patients With Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Metabolic Syndrome
Lead sponsor: National Nutrition and Food Technology Institute
Sponsor class: OTHER
First posted: 2018-05-02
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Metabolic syndrome is a public health challenge that includes a range of conditions including abdominal obesity, dyslipidemia, hyperglycemia, and hypertension. The syndrome is associated with an increase in the risk of Cardiovascular disease and death. Curcumin is a very active compound obtained from turmeric root. Curcumin has antioxidant and anti-inflammatory effects, and is also involved in the regulation of several signaling pathways. Since curcumin powder has low bioavailability, fast metabolism and low absorption, nanomicielle curcumin will be used in this study. Therefore, this study is planned to determine the effects of supplementation of nanomicielle curcumin on oxidative stress, systemic inflammation, adiponectin in serum and NF-kB in peripheral blood mononuclear cells in patients with metabolic syndrome.


Eligibility criteria: Inclusion Criteria:

* 25\<body mass index \>40
* waist circumference \>102 cm in men or \>88 cm in women
* Fasting blood glucose \>100 mg/dL
* Triglycerides (TG) \> 150 mg/dL
* High density lipoprotein cholesterol (HDL-C) \<50 in women or \<40 in men
* Systolic blood pressure (SBP) \>130 mmHg and diastolic blood pressure (DBP) \>85mmHg

Exclusion Criteria:

* insulin administration for diabetes control
* hypo- or hyperthyroidism,
* renal failure or other chronic diseases
* pregnancy and breastfeeding
* taking weight loss supplements and obeying unusual weight loss plans

Primary outcomes:
measure: Serum Total antioxidant capacity (TAC)
timeFrame: 12 weeks
measure: Serum Malondialdehyde (MDA)
timeFrame: 12weeks
measure: Serum C-reactive protein (CRP)
timeFrame: 12weeks
measure: Serum Adiponectin
timeFrame: 12weeks
measure: NF-kB(p65) transcription in PBMC
timeFrame: 12weeks
measure: Serum curcumin
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Golbon Sohrab
state: National Nutrition And Food Technology Research Institute
Study officials:
References:
Clinical trial NCT01103167: Body Composition Monitor in Hemodialysis Patients
Official title: The Association Between Body Composition and Biomarkers in Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: End Stage Renal Disease
Keywords: body composition
blood pressure
hemodialysis
Lead sponsor: Gachon University Gil Medical Center
Sponsor class: OTHER
Collaborators: name: Seoul National University Hospital
name: Seoul National University Bundang Hospital
First posted: 2010-04-14
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Control of volume status is a pivotal issue in haemodialysis therapy. Objective and practical management for maintaining normovolemia is needed.

The investigators hypothesized that intervention of volume status with the body composition monitor (BCM) may improved hemodynamic parameters and biomarkers in hemodialysis patients.

Detailed description: The investigators will assess BCM in enrolled hemodialysis patients by 4 weeks for 16 weeks During the former 8-week intervention period, The investigators will adjust patients' volume status according to the results of BCM.

During the latter 8-week observational period, The investigators will evaluate the changes of patients' hemodynamic parameters and biomarkers.

Eligibility criteria: Inclusion Criteria:

* 6-month or more stable hemodialysis patients
* 18 years or more
* less than 5% of changes of dry weight for last 3 months

Exclusion Criteria:

* pregnancy
* active malignancy
* cardiac pacemaker or defibrillator
* history of extremity amputation
* active infectious disease within 3 months
* admission history for complication related to hemodialysis within 3 months

Primary outcomes:
measure: blood pressure
timeFrame: up to 16 weeks
Secondary outcomes:
measure: biomarkers
timeFrame: up to 16 weeks
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Sejoong Kim
Study officials:
affiliation: Gachon University Gil Medical Center
name: Sejoong Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00321867: Graft-Augmented Rectocele Repair-A Randomized Surgical Trial
Official title: Porcine-Derived Small Intestine Submucosa Graft-Augmented Rectocele Repair-A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rectocele
Keywords: rectocele
pelvic prolapse
graft
surgical repair
Lead sponsor: Women and Infants Hospital of Rhode Island
Sponsor class: OTHER
First posted: 2006-05-04
Enrollment: 160
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether adding a graft during a rectocele repair will improve the success rate of the repair.

Detailed description: Rectoceles may have a significant effect on the quality of life of women. Symptoms associated with rectoceles include a protruding vaginal mass, persistent pelvic pressure, and sexual dysfunction. Surgical repair is the most common treatment with success rates ranging from 65%-85% at 1-2 years. In an attempt to improve surgical outcomes, clinicians are using graft materials to augment weakened tissues in rectocele repairs: however, there is little data to support or refute these practices. The purpose of this study is to estimate the effect of graft augmentation on objective and subjective outcomes.

Comparison: Rectocele repair without graft, compared to rectocele repair with the SurgiSIS (TM) graft.

Eligibility criteria: Inclusion Criteria:

* Women with stage 2 or greater symptomatic rectocele
* Women electing to undergo surgical rectocele repair
* Women over age 21 years
* Women willing to comply with study procedures and follow-up

Exclusion Criteria:

* Pregnant or nursing women
* History of porcine allergy
* History of connective tissue disease, pelvic malignancy, or pelvic radiation
* Women undergoing concurrent sacral colpopexy

Primary outcomes:
measure: Anatomic cure defined by standardized POPQ measures
timeFrame: 12 months
Secondary outcomes:
measure: Quality of life
timeFrame: 12 months
measure: Sexual function
timeFrame: 12 months
measure: Patient centered goals
timeFrame: 12 months
Other outcomes:
Locations:
city: Providence
country: United States
facility: Women and Infants Hospital of Rhode Island
state: Rhode Island
Study officials:
affiliation: Women and Infants Hospital
name: Vivian W Sung, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sung VW, Rardin CR, Raker CA, Lasala CA, Myers DL. Porcine subintestinal submucosal graft augmentation for rectocele repair: a randomized controlled trial. Obstet Gynecol. 2012 Jan;119(1):125-33. doi: 10.1097/AOG.0b013e31823d407e.
Clinical trial NCT03614767: Sacral Neuromodulation & Urodynamics
Official title: Assessment of Predictive Role of Urodynamics in Sacral Neuromodulation Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Overactive Bladder
Non-obstructive Urinary Retention
Lead sponsor: Universiteit Antwerpen
Sponsor class: OTHER
First posted: 2018-08-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with overactive bladder or non-obstructive urinary retention.

Brief summary: In the field of urology, sacral neuromodulation (SNM) is a well-accepted, second-line, minimally invasive treatment for patients with overactive bladder dry (OABD) or wet (OABW), and for patients with non-obstructive urinary retention (NOUR).

Long-term vary between 50-60%. This study examines whether urodynamics can be used as a predictor for successful SNM therapy


Eligibility criteria: Inclusion Criteria:

* Overactive bladder
* Non-obstructive urinary retention

Exclusion Criteria:

* Neurogenica disorder (e.g. cerebrovascular accident, spinal cord injury)

Primary outcomes:
measure: Change in bladder volume
timeFrame: 3 weeks
measure: Change in bladder sensation
timeFrame: 3 weeks
measure: Change in ice water test
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
facility: University of antwerp
state: Edegem
Study officials:
affiliation: University Hospital, Antwerp
name: Stefan De Wachter, MD PhD FEBU
role: STUDY_DIRECTOR
References: