louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01960829: Everolimus in Selected Patients With Metastatic Melanoma: Efficacy and Safety Study
Official title: A Single-armed, Open-labeled and Single-centered Phase II Trial of Everolimus in Selected Patients With Metastatic Melanoma: Efficacy and Safety Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Melanoma
TOR Serine-Threonine Kinases
Neoplasm Metastasis
Keywords: melanoma
TOR Serine-Threonine Kinases
Lead sponsor: Peking University Cancer Hospital & Institute
Sponsor class: OTHER
First posted: 2013-10-11
Enrollment: 60
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: This is a single-armed, open-labeled and single-centered study of everolimus in selective patients with metastatic melanoma for evaluation of the efficacy and safety. The study objective is to evaluate efficacy profile of everolimus.

The patients who comply with the inclusion and exclusion criteria will be enrolled. The estimated recruiting duration is 18 months. Everolimus will be given in the dose of 10 mg orally each day at lease 6 months unless disease progression or intolerance. The follow-up is till death(at least 1 year).


Eligibility criteria: Inclusion Criteria:

Clinical diagnosis of metastases melanoma. Must have evidence of mutations(Kinase domain) of mTOR . Must be ECOG performance status 0,1, or 2 . Must be estimated life expectancy of 3 months or greater. Must be age 18 years or older, male or female. Must have at least one measurable site of disease as defined by at least 1 cm in greatest dimension.

Adequate organ function. Must be willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.

Exclusion Criteria:

Prior systemic therapy for metastatic disease within 4 weeks. Second malignancy within the last 5 years. Severe and/or uncontrolled medical disease. Received RAD001 or other mTOR inhibitors previously . Hypersensitivity to everolimus Current treatment on another clinical trial. Pregnancy or breastfeeding.

Primary outcomes:
measure: To assess the progression-free survival (PFS) after treatment with everolimus in selected patients with metastatic melanoma (with mTOR mutation).
timeFrame: 18 months
Secondary outcomes:
measure: To assess the overall survival (OS) after treatment with everolimus in selected patients with metastatic melanoma (with mTOR mutation).
timeFrame: 18 months
measure: To evaluate the safety of and tolerability to everolimus in Chinese melanoma patients.
timeFrame: 18 months
measure: To evaluate the quality of life. Strategic goal: Explore and Capitalize on New Indications.
timeFrame: 18 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: LuSi
state: Beijing
Study officials:
References:
Clinical trial NCT05639829: Time-restricted Eating in Survivors Trial
Official title: Time-restricted Eating in Survivors Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer, Breast
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2022-12-06
Enrollment: 22
Sex: FEMALE
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Breast cancer survivors aged 60+ and with overweight/obesity who had completed chemotherapy 1-6 years earlier completed 8 weeks of 12-8 pm weekday-only time-restricted eating. The intervention was delivered by a registered dietitian call, twice-daily automated text messages asking about eating start/stop times, and three support phone calls.


Eligibility criteria: Inclusion Criteria:

* history of early-stage (I-III) breast cancer
* completed anthracycline-based chemotherapy 1-6 years earlier
* aged ≥60 years
* had a body mass index (BMI) \>25 kg/m2

Exclusion Criteria:

* taking lipid, glucose, or weight-lowering medications
* contraindications to maximal exercise testing or research MRI
* unstable thyroid disorder
* self-reported history of an eating disorder
* self-reported diagnosis of type 1 or 2 diabetes
* weight loss of ≥15 lbs in previous 3 months
* working night shifts
* could not provide consent in English

Primary outcomes:
measure: Framingham 10-year cardiovascular risk score (%)
timeFrame: 8 weeks
Secondary outcomes:
measure: Visceral adipose tissue
timeFrame: 8 weeks
measure: Thigh adipose tissue fraction
timeFrame: 8 weeks
measure: Liver adipose tissue fraction
timeFrame: 8 weeks
measure: Cardiorespiratory fitness
timeFrame: 8 weeks
measure: Resting energy expenditure
timeFrame: 8 weeks
measure: Respiratory quotient
timeFrame: 8 weeks
measure: Lipid profile
timeFrame: 8 weeks
measure: Hemoglobin A1c
timeFrame: 8 weeks
measure: Waist circumference
timeFrame: 8 weeks
measure: Fasting glucose
timeFrame: 8 weeks
measure: Fasting insulin
timeFrame: 8 weeks
measure: Resting systolic and diastolic blood pressure
timeFrame: 8 weeks
measure: Body mass
timeFrame: 8 weeks
measure: Whole-body fat mass
timeFrame: 8 weeks
measure: Whole-body fat-free mass
timeFrame: 8 weeks
Other outcomes:
measure: Dietary intake
timeFrame: 8 weeks
measure: Activity
timeFrame: Change between measurement at baseline and 8 weeks
measure: Adherence to intervention
timeFrame: Ongoing for duration of intervention
measure: Participant acceptability
timeFrame: 8 weeks
measure: Intervention fidelity
timeFrame: 8 weeks
measure: Intervention sustainability
timeFrame: 1 month post intervention
measure: Intervention sustainability confidence
timeFrame: 8 weeks
measure: Intervention delivery cost
timeFrame: Through study completion, lasting 12-24 weeks depending on chemotherapy protocol
measure: Symptoms
timeFrame: Through study completion, lasting 12-24 weeks depending on chemotherapy protocol
Locations:
city: Edmonton
country: Canada
facility: Edmonton Clinic Health Academy
state: Alberta
Study officials:
References:
Clinical trial NCT04351529: Austrian COVID-19 Registry
Official title: Austrian COVID-19 Registry (AGMT_COVID-19)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infectious Disease
COVID-19
Lead sponsor: Arbeitsgemeinschaft medikamentoese Tumortherapie
Sponsor class: OTHER
First posted: 2020-04-17
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: The AGMT_COVID-19 Registry is designed as multicenter observational cohort of patients, that are tested positive for SARS-CoV-2.

Brief summary: The AGMT_COVID-19 Registry is designed as multicenter observational cohort of patients, that are tested positive for SARS-CoV-2. Data will be collected from all sites in Austria willing to participate.

Due to the non-interventional nature of the AGMT_COVID-19 registry, only routine data, which has already been recorded in the patient's medical chart, is transferred to the eCRF.

Detailed description: Coronavirus disease 2019 (COVID-19) is an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The disease was first identified at the end of 2019 in Wuhan, the capital of Hubei province in central China, and has since spread globally.

There are currently no authorised vaccines or treatments in the EU (European Union) to prevent or treat novel coronavirus disease (COVID-19) specifically or any other coronaviruses.

The AGMT_COVID-19 Registry is designed as multicenter observational cohort of patients, that are tested positive for SARS-CoV-2. Data will be collected from all sites in Austria willing to participate.

Due to the non-interventional nature of the AGMT_COVID-19 registry, only routine data, which has already been recorded in the patient's medical chart, is transferred to the eCRF. Treatment indication, the decision to offer treatment, treatment choice, dose, schedule and dose reductions/escalations, and response assessments shall be exclusively based on the risk/benefit estimation of the treating physician.

Eligibility criteria: Inclusion Criteria:

* Age \>=18 years
* Positive test for SARS-CoV-2

Exclusion Criteria:

* Due to the non-interventional design of the registry there are no specific exclusion criteria.

Primary outcomes:
measure: Documentation of natural course and the therapeutic landscape of patients with COVID-19.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Feldkirch
country: Austria
facility: LKH Feldkirch: Innere Medizin II/ Interne E (Hämatologie und Onkologie)
city: Linz
country: Austria
facility: Kepler Universitätsklinikum Linz, Med. Campus III., Klinik für Lungenheilkunde / Pneumologie
city: Salzburg
country: Austria
facility: IIIrd Medical Department, Private Medical University Hospital Salzburg
city: Zams
country: Austria
facility: KH Zams: Innere Medizin Internistische Onkologie und Hämatologie
Study officials:
affiliation: IIIrd Medical Department, Private Medical University Hospital Salzburg
name: Richard Greil, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06226129: Gadopiclenol in Contrast Enhanced MRI of the Prostate
Official title: Gadopiclenol (Elucirem): A New Gadolinium Based Contrast Agent With High Relaxivity for Increased Contrast and Improved Differentiation of Clinically Significant Prostate Cancer on Contrast Enhanced MRI: A Prospective Study.
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE4
Conditions: Prostate Cancer
Keywords: MRI
Prostate
Contrast Agent
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: Guerbet
First posted: 2024-01-26
Enrollment: 150
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The fundamental aim of this study is to show that the novel contrast agent Gadopiclenol (Elucirem), with its high relaxivity, facilitates increased contrast enhancement and improved differentiation of clinically significant prostate cancer on Prostate MRI, as categorized by the PI-RADS v2 classification categories.

Detailed description: Gadolinium based contrast agents with higher relaxivity have been shown to improve contrast enhancement and differentiation of tissues with increased blood perfusion or with higher microvascular density (MVD), and therefore increase visibility of cancerous tissue. In this study, the objective is to demonstrate that Gadopiclenol facilitates the detection and classification of clinically significant prostate cancer, compared to T2-W (T2 weighted image) and diffusion weighted imaging (DWI), using the detailed location-specific (individual biopsy core for each annotated target) results of subsequently performed MRI-US fusion biopsies.

Eligibility criteria: Inclusion Criteria:

* Scheduled to undergo a clinically indicated MRI of the prostate with contrast.
* Scheduled to undergo, or likely to be scheduled to undergo, a prostate MRI-US fusion biopsy with histology results available within 6 months of their MRI.

Exclusion Criteria:

* Prisoner
* Have already begun therapeutic treatment for prostate cancer including surgery (TURP, prostatectomy), radiotherapy, hormone therapy or chemotherapy.
* Patients with end stage renal failure who are on dialysis. Patients who have chronic kidney disease or acute kidney injury are contraindicated for MRI per FDA and ACR (American College of Radiologists) guidelines and would thus be excluded as well.

Primary outcomes:
measure: Blinded Radiology Review of Enhancement of Images, Graded 1-5
timeFrame: Through Study Completion (An Average of 1 Year Post-MRI)
Secondary outcomes:
measure: Quantitative Measurements of Wash-In/Wash-Out Contrast Curve
timeFrame: Through Study Completion (An Average of 1 Year Post-MRI)
Other outcomes:
Locations:
city: Worcester
country: United States
facility: UMass Medical School
state: Massachusetts
Study officials:
affiliation: UMass Chan Medical School
name: B. Nicolas Bloch, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03966729: Relationships and Differences Analysis in Heart Failure
Official title: Retrospektive Datenanalyse Von Herzinsuffizienzpatienten in Der Kardiologie Des Universitätsklinikums Würzburg
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure
Chronic Heart Failure
Chronic Heart Disease
Keywords: HFmrEF
HFrEF
HFpEF
Heart Failure
Lead sponsor: Wuerzburg University Hospital
Sponsor class: OTHER
First posted: 2019-05-29
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Our cohort consists of patients who attended the Cardiology Department of University Hospital Wuerzburg in the time period between 2009 and 2019.

Brief summary: This study characterizes heart failure patients who attended the University Hospital Würzburg. The primary aim is a better understanding of the relationships and differences between the subgroups HFrEF (EF \< 40%), HFmrEF (EF 40-49%), and HFpEF (EF\>50%), contributing to an improved diagnosis, prognosis and therapy of patients with heart failure.

Detailed description: The varying clinical picture of heart failure (HF) represents a major challenge for patient care in Germany. HF is one of the most common reasons for hospitalization in the Western world. In the chronic course of heart failure, affected patients are committed to morbidity, lifelong therapy and high risk of cardiac decompensation, also associated with high mortality.

Heart failure patients, who visited the Cardiology Department of the University Hospital Wuerzburg, shall be analyzed with regard to all clinical data and outcome. This retrospective work should help to better understand the three groups HFrEF (EF \< 40%), HFmrEF (EF 40-49%) and HFpEF (EF\>50%) and help identifying similarities and differences between the groups.

Hereby we hope for progress in diagnostic, prognostic and therapeutic aspects of heart failure.

Eligibility criteria: Inclusion Criteria:

* Diagnosis: Heart failure
* Minimum of two echocardiographic examinations in a minimum time frame of six months
* Patients must have reached the age of 18

Primary outcomes:
measure: Long-term survival in heart failure patients with preserved, mid-range or reduced left ventricular ejection fraction
timeFrame: 1 year follow up after last examination
Secondary outcomes:
measure: Impact of clinical imaging and laboratory parameters on long-term survival in heart failure patients with precerved, mid-range or reduced left ventricular ejection fraction
timeFrame: 6 months
Other outcomes:
Locations:
city: Würzburg
country: Germany
facility: University Hospital Würzburg
state: Bavaria
Study officials:
affiliation: Wuerzburg University Hospital
name: Peter Nordbeck, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05481229: Nutrition Childhood Cancer Survivors
Official title: Nutritional Status of Cured Pediatric Cancer Patients in Adulthood, the Role of Adipokines in the Development of Cardiometabolic Complications and Desirable Nutritional Interventions
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Childhood Cancer
Nutrition Disorders
Keywords: children cancer survivors
adiposity
late effects
nutriton
adipokines
Lead sponsor: Masaryk University
Sponsor class: OTHER
Collaborators: name: St. Anne's University Hospital Brno, Czech Republic
First posted: 2022-08-01
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population is patients who have been treated for childhood or adolescent cancer and who are now being followed up in a dispensary clinic.

Brief summary: NUTRITION CCS is a cross-sectional, descriptive study to assess the relationship between body composition and demographic, socioeconomic status, treatment modalities and blood samples of survivors who were in remission. The study was conducted in the Clinic for childhood cancer survivors. The clinic is attended by patients older than 18 years and was built in 2016 at the St. Anne's Hospital in Brno.

Detailed description: NUTRITION CCS is a cross-sectional, descriptive study to assess the relationship between body composition and demographic, socioeconomic status, treatment modalities and blood samples of survivors who were in remission.

Objectives of the study

1. to determine the prevalence (incidence) of nutritional disorders, especially obesity and metabolic syndrome, in cured paediatric cancer patients in adulthood;
2. to investigate the role of adipokines in the development of cardiometabolic complications in this group of patients; 3. to determine whether targeted dietary and lifestyle interventions can lead to improvements in nutritional status and subjectively perceived quality of life of treated paediatric cancer patients in adulthood and objectively assessed cardiometabolic risk

Eligibility criteria: Inclusion Criteria:

* Patients after treatment from childhood and adolescent cancers.
* The subject is male or female, aged 18 - 64 years

Exclusion Criteria:

* Patients with acute cancer therapy
* Pregnant women

Primary outcomes:
measure: Define the relationship between the levels of adipokines and cardiometabolic diseases.
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Determine the prevalence of hight body fat and decreased skeletal muscle.
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: Masaryk University
city: Brno
country: Czechia
facility: St. Anne Hospital in Brno
Study officials:
affiliation: Department of Pathological Physiology and RECETOX, Masaryk University, Kamenice 5,
name: Julie Bienertová-Vašků, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06560229: Giving Resources to LOw-income Children to Enhance RecoverY
Official title: Giving Resources to LOw-income Children to Enhance RecoverY
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Discharged Pediatric Patients and Their Families
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2024-08-19
Enrollment: 400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this clinical trial is to learn if an intervention to provide food support to families who are part of a Medicaid Accountable Care Organization will provide benefits. The main question it aims to answer:

Does this monthly food support intervention reduce food insecurity and healthcare utilization in these patients.

Participants will complete surveys in the hospital, 14-days after discharge, and then quarterly for up to 18 months. Families randomized to the intervention group will receive monthly grocery gift cards for one year.


Eligibility criteria: Inclusion Criteria:

* Parent of a pediatric patient admitted to one of two units at our hospital with HealthVine insurance

Exclusion Criteria:

* Previous study participation

Primary outcomes:
measure: Reutilization
timeFrame: 30-days after discharge, 90-days after discharge, and quarterly after discharge up to 20 months
measure: UDSA 6-question food insecurity survey
timeFrame: 14-days after discharge, 90-days after discharge, and quarterly after discharge up to 20 months
Secondary outcomes:
measure: Primary Care Healthcare Utilization
timeFrame: 30-days after discharge, 90-days after discharge, and quarterly after discharge up to 20 months
measure: Vaccine uptake at primary care clinic
timeFrame: 30-days after discharge, 90-days after discharge, and quarterly after discharge up to 20 months
measure: Recovery and return to normal routine
timeFrame: 14-days after discharge
measure: Post-Discharge Difficulty Coping Scale
timeFrame: 14-days after discharge
measure: Ability to pay for medications
timeFrame: 14-days after discharge, 90-days after discharge, and quarterly after discharge up to 20 months
measure: Perceived Stress Scale
timeFrame: 14-days after discharge, 90-days after discharge, and quarterly after discharge up to 20 months
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
References:
Clinical trial NCT01845129: Impact of Transcranial Direct Current Stimulation of the Motor Cortex on Language Functions in Residual Aphasia
Official title: Impact of Transcranial Direct Current Stimulation of the Motor Cortex on Language Functions in Residual Aphasia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Residual Aphasia
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2013-05-03
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The present study assesses whether language functions in patients with residual post-stroke aphasia can be improved by transcranial direct current stimulation administered to the primary motor cortex in the language dominant (left) hemisphere.

Detailed description: Patients will participate in two tDCS sessions (atDCS; sham) in a cross-over within subjects design. tDCS or placebo will be administered during simulatneous fMRI to assess neural signatures of the stimulation. Order of stimulation will be counterbalanced between subjects

Eligibility criteria: Inclusion Criteria:

* right handedness
* German native speaker
* cerebrovascular stroke in left hemisphere (\>6 months)
* mild aphasia (according to Aachen Aphasia Test Battery Classification, Huber et al., 1983)
* residual anomia in naming test (\>75 correct responses)

Exclusion Criteria:

* other current or previous neurological or psychiatric diseases
* alcohol or drug abuse
* MRI contraindication (e.g. magnetic metal, pacemaker, claustrophobia)

Primary outcomes:
measure: Response latency during picture naming task (max. 80)
timeFrame: Change in response latency between assessment 1 (week 1) and assessment 2 (week 2), assessments 1 and 2 are seperated by one week
Secondary outcomes:
measure: Change in neural activity measured by functional magnetic resonance imaging
timeFrame: Change in fMRI activity between Assessment 1 (week 1) and Assessment 2 (week 2), assessments 1 and 2 are seperated by one week
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charite, University Medicine, Dept. of Neurology
Study officials:
affiliation: Charite, University Medicine, Neurology
name: Marcus Meinzer, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Charite, University Medicine, Neurology
name: Agnes Flöel, MD
role: PRINCIPAL_INVESTIGATOR
References: