louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04550533: DESIGN OF A SCALE TO MEASURE COMPLIANCE WITH DRUG TREATMENT IN PATIENTS WITH ORAL CHEMOTHERAPY
Official title: DESIGN AND VALIDATION OF A SCALE TO EVALUATE THERAPEUTIC ADHERENCE IN PATIENTS WITH ANTINEOPLASTIC DRUGS
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Adherence, Medication
Lead sponsor: Universidad Miguel Hernandez de Elche
Sponsor class: OTHER
First posted: 2020-09-16
Enrollment: 288
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients over the age of 18 in treatment with oral anti-cancer drugs (groups L01 and L02 according to the ATC drug classification) who come to hospital to collect their medication,

Brief summary: Introduction: In recent years, there has been an increase in the use of oral chemotherapy, for its comfort and for allowing a higher quality of life. However, one of the main drawbacks is the lack of adherence to treatment with important clinical, social and economic consequences. In this scenario, the investigators did not have a questionnaire designed and validated to measure adherence in onco-hematological patients, a population that was erroneously considered very adherent.

The objective of the investigators is to build and validate a questionnaire to measure adherence to treatment in oncohematological patients in treatment with oral anti-cancer drugs.

Methods and analysis: An observational study to validate questionnaires will be carried out combining qualitative and quantitative research techniques. With the results of a systematic review of the literature and a qualitative study based on focus groups, a questionnaire will be designed to measure adherence in oncohematological patients in treatment with with oral anti-cancer drugs. The investigators will include patiens from two hospitals in the Valencian Community.

Discussion: It is essential to have a simple, reliable and validated instrument for measuring adherence in cancer patients undergoing treatment with oral antineoplastic agents. With this, lack of therapeutic compliance and its causes can be detected in order to establish interventions that improve it.


Eligibility criteria: Inclusion Criteria:

* Patients over the age of 18 in treatment with oral anti-cancer drugs (groups L01 and L02 according to the ATC drug classification), that come to the San Juan Hospital or Elda General Hospital to collect their medication, will be included.

Exclusion Criteria:

* Those patients with communication difficulties, and/or do not agree to take part in the study, will be excluded

Primary outcomes:
measure: Measure of therapeutic adherence
timeFrame: At least 3 month after treatment
Secondary outcomes:
measure: Barriers and difficulties in evaluating adherence
timeFrame: At least 3 month after treatment
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04462133: Optimal Tailored Treatment for H. Pylori Infection
Official title: Optimal Tailored Treatment for H. Pylori Infection According to the Presence of DPO-PCR Based Clarithromycin Resistance
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Helicobacter Pylori Infection
Antibiotic Resistant Infection
Lead sponsor: Incheon St.Mary's Hospital
Sponsor class: OTHER
First posted: 2020-07-08
Enrollment: 0
Sex: ALL
Minimum age (years): 19
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Empirical treatment versus tailored therapy
Primary purpose: TREATMENT

Brief summary: The efficacy of the current standard triple therapy is at an unacceptably low level. Resistance to antibiotics is suspected to be the major cause of the low efficacy of standard triple therapy. Point mutations in the 23S rRNA gene are known to be the primary mechanism of clarithromycin resistance against H pylori. Recently, a point mutation detection kit using a dual-priming oligonucleotide (DPO)-based multiplex polymerase chain reaction (PCR) assay was introduced and made commercially available. The primary goal of our study was to compare the eradication rates of empirical therapy and tailored therapy. Specifically we examined the eradication rates of 7-d, 14-d empirical therapy with 7-d, 14-d tailored therapy. Our secondary goal was to examine the adverse events of each treatment, cost effectiveness of each treatment methods, and accuracy of DPO-PCR for detecting H. pylori resistance.

Detailed description: Patients are randomly assigned to the empirical therapy group and tailored therapy group.

The empirical therapy group recieves triple therapy of 7 or 14 days. The tailored therapy group receives treatment based on their DPO-PCR results.

Patients who are sensitive to clarithromycin based on DPO-PCR receives triple therapy for 7 or 14 days. Patients who are resistant to clarithromycin based on DPO-PCR recieves bismuth quadruple therapy for 7 or 14 days.

Eligibility criteria: Inclusion Criteria:

* consecutive subjects who underwent upper gastrointestinal endoscopy and who had a confirmed diagnosis of H pylori infection

Exclusion Criteria:

* subjects younger than 18 years old
* subjects with a history of H pylori eradication
* subjects who had previous gastric surgery
* subjects who were pregnant or lactating
* subjects with serious concurrent illness
* subjects who were administered antibiotics, bismuth, or PPIs in the 8 weeks preceding the study
* subjects with a history of allergy to any one of the compounds in this study

Primary outcomes:
measure: Eradication success
timeFrame: 8-12 weeks after eradication
Secondary outcomes:
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: Incheon St. Mary's Hospital
Study officials:
affiliation: Incheon St.Mary's Hospital
name: Byung-Wook Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05684133: REMISE Study: REMnant Biospecimen Investigation in SEpsis
Official title: REMISE Study: REMnant Biospecimen Investigation in SEpsis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Vanderbilt University
name: National Institute of General Medical Sciences (NIGMS)
First posted: 2023-01-13
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with Sepsis-3 presenting to eligible emergency departments.

Brief summary: In the REMISE is study, we will compare blood proteins, biomarkers, and other -omics prospectively collected from patients with sepsis from two sources, i.) remnant (discarded) samples from the clinical laboratory, and ii.) prospectively collected in UPMC Presbyterian hospital research coordinator specimen collected biospecimens.

Analyses will include traditional biomarkers, quantitative proteomics, metabolomics, lipidomics, transcriptomics, and pathogen genomic sequencing in both sets of samples. This data will allow the assessment of the feasibility, integrity, and scientific value of remnant samples compared to research coordinator samples collected at the bedside for mechanistic sepsis research.


Eligibility criteria: Inclusion Criteria:

* Adult patient, at least 18 years of age
* Meeting Sepsis-3 criteria within 6 hours of admission
* Biospecimens obtained for routine clinical care and measurement
* Peripheral intravenous access

Exclusion Criteria:

* Patients who do not have Sepsis-3
* Traumatic injury,
* Inability to consent or contact legal representative,
* Cardiac arrest,
* Stroke,
* Comfort measures only,
* Unable to obtain intravenous access, and/or
* Subject declines to participate.
* No residual blood left in clinical sample

Primary outcomes:
measure: Difference in traditional biomarkers, proteomics, pathogen sequencing, and metabolomics/lipidomics between prospectively collected biospecimens and remnant biospecimens.
timeFrame: 01/2024
Secondary outcomes:
measure: Measurement of traditional biomarkers in all samples
timeFrame: 1/2024
measure: Measurement of proteomics in all samples
timeFrame: 1/2024
measure: Measurement of metabolomics/lipidomics in all samples
timeFrame: 1/2024
measure: Pathogen sequencing in all samples
timeFrame: 1/2024
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh / UPMC
name: Christopher Seymour, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02694133: Efficacy of Telerehabilitation in the Patients With Aphasia
Official title: Efficacy of Telerehabilitation in the Patients With Aphasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aphasia
Keywords: telerehabilitation
aphasia
speech therapy
rehabilitation device
visual action therapy
naming drills
Lead sponsor: Kaohsiung Veterans General Hospital.
Sponsor class: OTHER
First posted: 2016-02-29
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study will invite 30 patients to join, and they will be arranged in the face to face group and telerehabilitation group randomly.

In the telerehabilitation group, the investigators use the mobile device, which with the camera and speaker, for patients to practice the naming training at home, and assess the speech ability every 2-4weeks by speech therapist via telerehabilitation platform.

Concise Chinese Aphasia Test (CCAT) and ASHA FACS conceptual framework Test will be used as the assessment tool for evaluation speech ability and functional ability.

The investigators expect that patients can improve their speech ability, functional ability, and quality of life via telerehabilitation speech therapy.

And the investigators can establish the standard telerehabilitation speech therapy protocol for aphasia therapy.


Eligibility criteria: Inclusion Criteria:

* patients diagnosed as aphasia

Exclusion Criteria:

* poor auditory comprehension

Primary outcomes:
measure: Concise Chinese Aphasia Test
timeFrame: monthly changes within 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05972733: Serologic Assay Validation and Proficiency Testing of HIL-214 in Adults
Official title: Phase 2, Single-arm, Open-label Trial for Serologic Assay Validation, Proficiency Testing, Safety and Immunogenicity of the Intramuscular HIL-214 Norovirus Vaccine in Adults Aged 18 to 49 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastroenteritis
Lead sponsor: HilleVax
Sponsor class: INDUSTRY
First posted: 2023-08-02
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-arm, Open-label Trial
Primary purpose: PREVENTION

Brief summary: The purpose of this trial is to obtain serum for proficiency testing to confirm assay validity is maintained following the dosing of adults with a pediatric dose of HIL-214.

Detailed description: This single-arm trial serves to obtain serum for proficiency testing to confirm assay validity is maintained. Exploratory aspects of this trial include evaluating additional assays used for the assessment of immune responses to HIL-214 in peripheral-blood samples. Given the large volume of blood required, the pediatric dose will be tested in healthy adults. The main scientific rationale for the trial is to identify immune assays that can assess the generation of serum antibodies or cell-mediated immunity (CMI) specific to norovirus strains not represented in the HIL-214 vaccine (i.e. cross-reactivity).

Eligibility criteria: Inclusion Criteria:

* Male or female subjects aged 18 to 49 years, inclusive.
* Individuals who are in good health at the time of entry into the trial as determined by medical history, physical examination (including vital signs) and clinical judgment of the investigator.
* The individual signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any trial procedures, after the nature of the trial has been explained according to regulatory requirements.
* Individuals willing and able to comply with trial procedures and are available for the duration of follow-up.

Exclusion Criteria:

* Females who are pregnant or breastfeeding.
* Gastroenteritis within 14 days before planned dosing (can warrant delay of trial vaccine administration).
* Known hypersensitivity or allergy to any of the HIL-214 components (including excipients).
* Known or suspected impairment/alteration of immune function, including history of any autoimmune disease or neuro-inflammatory disease.
* Any serious chronic or progressive disease (including hepatitis B or C).
* Previous exposure to an experimental norovirus vaccine.
* Subject or subject's first-degree relatives are involved in the trial conduct.

Primary outcomes:
measure: Primary Immunogenicity for Panel Formation
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rolling Hills Estates
country: United States
facility: Pennisula Research Associates
state: California
city: Stockbridge
country: United States
facility: Clinical Research Atlanta
state: Georgia
Study officials:
References:
Clinical trial NCT04720833: Effect of Dried Plum on Bone and Markers of Bone Status in Men
Official title: Effect of Dried Plum on Bone and Markers of Bone Status in Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis
Osteopenia
Keywords: Prunes
dried plum
nutrition
bone
Lead sponsor: San Diego State University
Sponsor class: OTHER
First posted: 2021-01-22
Enrollment: 66
Sex: MALE
Minimum age (years): 50
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects will be randomly assign to one of the arms.
Primary purpose: PREVENTION

Brief summary: The principal objective of this study is to examine whether the addition of 100 g dried plum to the diets of men, regardless of their bone status, positively influences their indices of bone turnover in comparison with their corresponding baseline values and the control regimen.

Detailed description: To test the bone protective properties of dried plum, 66 men (50 to 79 years of age) will receive either 100 g dried plum/day or a control regimen for 12 months. Both groups will receive 500 mg calcium and 400 IU vitamin D daily.

Evaluation will be based on analyses of bone mineral density at baseline, 6 and 12-months and serum and urine markers of bone formation and resorption at baseline and 3, 6, and 12-months.

Eligibility criteria: Inclusion Criteria:

* Healthy men (50-79 year-old)

Exclusion Criteria:

* endocrine (e.g., prednisone, other glucocorticoids) or neuroactive (e.g., dilantin, phenobarbital) drugs or any drugs known to influence bone and calcium metabolism
* Men whose BMD t-score at any site falls below 2.5 SD of the mean will be excluded from the study and referred to their primary care physician
* subjects treated with calcitonin, bisphosphonates, raloxifene, sodium fluoride, anabolic agents, e.g. PTH and growth hormone, or steroids for less than 3 months prior to the start of the study will be excluded.
* body mass index (BMI) \<18 and \>30 will be excluded to avoid extremes in leanness/adiposity and to readily allow body composition assessment.
* If subjects smoke 20 cigarettes or more per day, they will be excluded.
* Men who regularly consume dried plum or prune juice will not be accepted into the study.

Primary outcomes:
measure: Bone biomarkers
timeFrame: changes from baseline to 3 months
Secondary outcomes:
measure: Bone mineral density
timeFrame: changes from baseline to 12 months
Other outcomes:
Locations:
city: San Diego
country: United States
facility: School of Exercise and Nutritional Sciences
state: California
Study officials:
affiliation: San Diego State University
name: Shirin Hooshmand, PhD, RD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hooshmand S, Gaffen D, Eisner A, Fajardo J, Payton M, Kern M. Effects of 12 Months Consumption of 100 g Dried Plum (Prunes) on Bone Biomarkers, Density, and Strength in Men. J Med Food. 2022 Jan;25(1):40-47. doi: 10.1089/jmf.2021.0080. Epub 2021 Oct 29.
Clinical trial NCT03176433: Post Static Cold Storage Normothermic Machine Liver Perfusion
Official title: A Multicentre, Single-arm, Prospective Clinical Trial to Investigate the Safety and Feasibility of Cold Storage Prior to Normothermic Machine Perfusion in Adult Human Liver Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Liver Transplantation
Lead sponsor: University of Oxford
Sponsor class: OTHER
First posted: 2017-06-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to assess the safety and feasibility of a short period of cold storage prior to normothermic machine perfusion in adult liver transplantation.


Eligibility criteria: Donor Inclusion Criteria:

* Donors over the age of 16 years.
* Liver allografts from donation after brain death (DBD), standard and extended criteria donors. (SCD, ECD) and donation after circulatory death (DCD) donors.
* Liver must be perfused on OrganOx metra perfusion device within 8 hours of in situ cold perfusion.
* The perfusion should last a minimum of 4 hours and maximum of 24 hours.

Donor Exclusion Criteria:

* Living donors.
* Liver being transplanted as part of a multi-organ transplant (eg liver and kidney).
* Liver intended for split transplant.
* Donor age \<16 years
* Liver which investigator is unwilling to recruit to study.
* Any liver in which logistics prevent perfusion on the OrganOx metra perfusion device within 8 hours of in situ cold perfusion.

Recipient Inclusion Criteria:

* Adult patients (18 years or more).
* Active on the waiting list for liver transplantation.
* Able to give informed consent.

Recipient Exclusion Criteria:

* Age less than 18 years.
* Acute/fulminant liver failure.
* Transplantation of more than one organ (e.g. liver and kidney).
* Refusal of informed consent.
* Unable to give informed consent.

Primary outcomes:
measure: Patient and Graft Survival
timeFrame: 30 days
Secondary outcomes:
measure: Peak serum AST (U/L)
timeFrame: 7 days
measure: Early allograft dysfunction (EAD)
timeFrame: 7 days
measure: Primary non-function
timeFrame: 10 days
measure: Adverse events, transplantation and organ discard rates.
timeFrame: 30 days
measure: Biliary investigation or intervention
timeFrame: 6 months
measure: Patient and Graft Survival
timeFrame: 6 months
measure: Patient and Graft Survival
timeFrame: 12 months
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital
city: London
country: United Kingdom
facility: King's College Hospital
city: London
country: United Kingdom
facility: Royal Free Hospital
Study officials:
affiliation: University of Oxford
name: Peter Friend
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00909233: LEVITRA® 20mg Special Drug Use Investigation (Long-term)
Official title: LEVITRA® 20mg Special Drug Use Investigation (Long-term)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Erectile Dysfunction
Keywords: Erectile dysfunction,
Phosphodiesterase Inhibitors
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2009-05-27
Enrollment: 1221
Sex: MALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic

Brief summary: This investigation targets either the patients of 18 years-old or older and under 65 years-old with organic or mixed erectile dysfunction (ED) who cannot obtain sufficient efficacy by dose 10mg of Levitra, and the target patients dose is increased to Levitra 20mg. This investigation will be limited to the patients whose tolerability of Levitra 10mg is judged to be no problem.


Eligibility criteria: Inclusion Criteria:

* This investigation targets either the patients of 18 years-old or older and under 65 years-old with organic or mixed erectile dysfunction who cannot obtain sufficient efficacy by dose 10mg of Levitra, and the target patients dose is increased to Levitra 20mg. This investigation will be limited to the patients whose tolerability of Levitra 10mg is judged to be no problem.

Primary outcomes:
measure: Efficacy of patients with LEVITRA treatment
timeFrame: After 6 months
Secondary outcomes:
measure: LEVITRA treatment improved the patient's erection
timeFrame: After 6 months
measure: LEVITRA improved the patient's erection after Minimum and Maximum Intervals between LEVITRA intake and the start of intercourse
timeFrame: After 6 months
measure: Reporting a second successful intercourse within 24 hours of dosing
timeFrame: After 6 months
measure: Patients prefer LEVITRA over last Erectile Dysfunction treatment
timeFrame: After 6 months
measure: Tolerability of patients with LEVITRA treatment
timeFrame: After 6 months
Other outcomes:
Locations:
city: Many locations
country: Japan
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03701633: Uterine Artery Doppler Changes Prior and After Breastfeeding
Official title: Postpartum Uterine Artery Doppler Changes Prior and After Breastfeeding
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breastfeeding
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2018-10-10
Enrollment: 500
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Every woman who had vaginal delivery, instrumental delivery or cesarean section.

Brief summary: We aim to determine whether there are any differences in the UtA doppler measurements in postpartum women prior and right after breastfeeding.

Detailed description: There is emerging evidence linking abnormal UtA Doppler indices in the postpartum period as a risk factor for developing future cardiovascular disorders. Thus far, no study considered the postpartum physiology itself as a possible confounder. If one wishes to draw conclusions about future cardiovascular risk, the role of oxytocin as a confounder must be determined. In the current study, we aim to determine whether oxytocin, physiologically produced during breastfeeding, has an effect on the UtA Doppler measurements in the postpartum period.

Eligibility criteria: Inclusion Criteria:

-Every woman who had vaginal delivery, instrumental delivery or cesarean section.

Exclusion Criteria:

-Patient's refusal, women who decided not to breastfeed, women who wish to breastfeed, but in whom no milk production commenced yet.

Primary outcomes:
measure: Postpartum uterine artery doppler changes prior and after breastfeeding.
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam health care campus
Study officials:
affiliation: Rambam Health Care Campus
name: Yaniv Zipori, M.D
role: PRINCIPAL_INVESTIGATOR
References: