louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02811224: Ovarian Cancer Hemoscope Trial
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Ovarian Neoplasms
Lead sponsor: Scripps Translational Science Institute
Sponsor class: OTHER
First posted: 2016-06-23
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women undergoing surgery as part of the treatment plan for ovarian cancer or a benign gynecological neoplasm.

Brief summary: This is a prospective, gold standard observational trial designed to enroll consecutive, consenting ovarian cancer patients for the purpose of determining sensitivity of an assay that detects circulating tumor DNA. This observational pilot trial will also be used to examine the genetic variants/mutations present in the tumor tissue DNA.


Eligibility criteria: Inclusion Criteria:

Case Group

* Patients with ovarian cancer undergoing surgery (all stages)
* Over 18 years old

Control Group

* Patients with a benign gynecological condition undergoing surgery
* Over 18 years old

Exclusion Criteria:

* Previous cancer diagnosis (all)
* Radiation therapy before surgical treatment
* Bone marrow transplant
* Chemotherapy before surgical treatment
* Invasive procedure resulting in damage to tissue (e.g., surgery, biopsy, thermal ablation) in the 7 days prior to baseline (pre-surgical) blood collection

Primary outcomes:
measure: Sensitivity of an assay that detects circulating tumor DNA
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02481024: Impact of Care Transition on Medication Adherence in Cardiac Patients
Official title: 'Moving From Hospital to Home' - Exploring the Impact of Care Transition on Medication Adherence in Cardiac Patients: a Qualitative Study Protocol
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Coronary Syndrome
Keywords: Qualitative
Care transition
Medication
Lead sponsor: King's College London
Sponsor class: OTHER
First posted: 2015-06-25
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients hospitalised after an acute coronary syndrome event.

Brief summary: Background:

Medication adherence following acute coronary syndrome (ACS) is often sub-optimal. Poor adherence is associated with increased risk of rehospitalisation along with higher rates of morbidity and mortality. After a cardiac event, transitioning from hospital into primary care can be problematic if it is not organised or coordinated properly. Patients can often find themselves unprepared and lacking the necessary information for self-management of their disease. The impact of care transition on medication adherence has not been studied in ACS.

Objectives:

This study will explore how an ACS patients' journey from hospital into primary care affects medicines use. Further, to understand how medicine information is communicated and how this influences patient beliefs about medicines.

Methods:

This is an interview study with recently hospitalised ACS patients discussing medication beliefs, communication of medicine information and the challenges when transitioning from specialist to primary care. Patients will be recruited from Guy's and St Thomas' NHS Foundation Trust and telephone interviews will be scheduled 3-4 weeks post-discharge. An inductive thematic analysis will be used to identify, construct and analyse patterns in the data and to develop a framework analysis. Analysis will be an iterative process conducted in parallel with data collection to highlight when data saturation has been reached.

Dissemination:

The primary objective is to develop a pharmacist-led behaviour change intervention to improve rates of medication adherence following an ACS. The in-depth patient data collected in this current study will contribute to the design and development of the intervention. Understanding the research topic from the patients' perspective is a necessity when designing an intervention targeting behaviour change.


Eligibility criteria: Inclusion Criteria:

* over 18 years of age
* have a confirmed index diagnosis of ACS
* have sufficient spoken English to partake in an interview

Exclusion Criteria:

* under 18 years of age
* lack the level of spoken English required to be interviewed

Primary outcomes:
measure: Patient experiences
timeFrame: 3-4 weeks after discharged from hospital
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Guy's and St Thomas' NHS Foundation Trust
Study officials:
References:
Clinical trial NCT01798524: Kidney Allograft Recipients in England - an Observational Cohort Study
Official title: An Observation Cohort Study of Kidney Allograft Recipients in England by Data Linkage Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Transplantation
Keywords: Transplant
Kidney
England
Lead sponsor: University Hospital Birmingham NHS Foundation Trust
Sponsor class: OTHER
First posted: 2013-02-26
Enrollment: 19688
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: All kidney allograft recipients transplanted at an English transplant centre between April 2001 and March 2012

Brief summary: Kidney transplantation is the renal replacement therapy of choice for the majority of patients with end-stage kidney disease. Epidemiological studies of kidney allograft recipients can aid in the understanding of cause and effect of health and disease post-transplantation. The combination of health care and information technology has made the potential of transplant professionals to use health information effectively crucial to guide kidney transplant management. The aim of this study is to undertake an observational cohort study of kidney allograft recipients, supported by linking analysis across different database sources, to provide a comprehensive biomedical dataset of information.


Eligibility criteria: Inclusion Criteria:

* Kidney transplant alone
* English Transplant centre
* All ages
* Kidney allograft receipt between April 2001 and March 2012

Exclusion Criteria:

* Multiple organ transplant
* Transplant performed at non-English centre

Primary outcomes:
measure: Mortality within the first year post kidney transplantation
timeFrame: One year
Secondary outcomes:
measure: Mortality beyond the first year post kidney transplantation
timeFrame: Up to 12 years
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: University Hospitals Birmingham NHS Foundation trust
Study officials:
References:
Clinical trial NCT01834924: Improving Communication of Medication Instructions to Parents
Official title: Dissemination of a Health Literacy Intervention to Improve Provider-Patient Communication of Medication Instructions and Decrease Outpatient Pediatric Medication Errors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medication Errors
Medication Adherence
Keywords: Health literacy
Patient education
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: New York City Health and Hospitals Corporation
name: Robert Wood Johnson Foundation
First posted: 2013-04-18
Enrollment: 1196
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Almost half of all US adults have trouble understanding and using health information, or low health literacy. Health literacy is considered to be an important patient safety issue, and has been linked to poor medication management. Low health literacy is a risk factor for parent errors in administering medications to their children; difficulty understanding provider medication instructions is likely to contribute to errors.

To address these issues, bilingual (English/Spanish), low literacy, picture-based medication instruction sheets were developed. This study will look at the effectiveness and feasibility of the medication instruction sheet-based intervention as it is used by providers in 2 pediatric emergency department settings, as part of a planned roll out of HELPix within the hospital system. The investigators hypothesize that there will be reduced medication dosing errors, improved medication adherence, reduced hospital revisit rates, and improved provider-parent communication. The investigators also hypothesize that provider technology experience, knowledge, and attitudes, will affect the extent to which providers use the tool.


Eligibility criteria: Parent Inclusion Criteria:

* child \<=8 years
* child prescribed a daily dose short course (\<14 day) liquid medication

Parent Exclusion Criteria:

* caregiver not legal guardian of child
* caregiver non-English/ Spanish language
* caregiver residency outside of New York City
* hospital admission of child
* child with psychiatric or child protection-related issue
* no listed phone number for caregiver
* person reached by phone not person counseled in the emergency department
* no eligible medication prescribed

Primary outcomes:
measure: Medication dosing error (observed)
timeFrame: within 8 weeks of the end date of prescribed course of medication
Secondary outcomes:
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: Woodhull Hospital
state: New York
city: New York
country: United States
facility: Bellevue Hospital Center
state: New York
Study officials:
affiliation: NYU School of Medicine / Bellevue Hospital Center
name: H. Shonna Yin, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05316324: A Study of the Use of Acellular Dermal Matrix for Breast Reconstruction
Official title: A Randomized Controlled Trial of Prepectoral Breast Reconstruction With and Without Acellular Dermal Matrix
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Breast Cancer
Keywords: Acellular Dermal Matrix
Breast Reconstruction
Mastectomy
22-071
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: The Plastic Surgery Foundation
First posted: 2022-04-07
Enrollment: 353
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The researchers are doing this study to look at the number of complications that occur immediately after prepectoral breast reconstruction when Acellular Dermal Matrix (ADM) is used compared to when ADM is not used. These complications include infections, the need for Tissue Expander (TE) or implant removal, and other conditions that lead to additional surgery.


Eligibility criteria: Inclusion Criteria:

* Females aged 21-60 years
* Planning to undergo unilateral or bilateral mastectomy, prophylactically or to treat breast cancer
* Planning to undergo immediate two-stage prosthetic breast reconstruction with TE placement as the first stage
* Planning to undergo nipple-sparing or skin-sparing mastectomy
* Adequate mastectomy skin perfusion or adequate perfusion but nonviable mastectomy skin that can be excised (≤4 cm) at the defect margins with otherwise adequate perfusion
* Intraoperative confirmation of prepectoral plane viability by operating physician

Exclusion Criteria:

* History of radiotherapy to the operative breast
* Current smoker
* Non-English speaking patients
* Planning to undergo direct-to-implant reconstruction
* Prior sternotomy

Primary outcomes:
measure: Percentage of patients who experience major complications
timeFrame: 90 days
Secondary outcomes:
measure: Estimate rates of minor complications (specifically seroma)
timeFrame: 90 days
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (All Protocol Activities)
state: New York
city: Rockville Centre
country: United States
facility: Memorial Sloan Kettering Nassau (Limited Protocol Activities)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Evan Matros, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03129724: Retrospective Study in Patients With Metastatic Renal Cancer Treated With TKI Sequence (Tyrosine Kinase Inhibitors of VEGFR) - mTOR- Axitinib Inhibitors or Anti-VEGF Antibody -Inhibiteurs mTOR - Axitinib
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Kidney Neoplasms
Keywords: Kidney Neoplasms
Kidney
Neoplasms
TKI
Axitinib
VEGF
mTORi
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2017-04-26
Enrollment: 100
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: Patient with metastatic kidney cancer (all histological types) Patient has been treated or under treatment with axitinib (Inlyta®) in the third line after the first line of targeted TKI therapy and after mTORi in 2nd line, or Patient receiving the treatment sequence VEGFmAb - mTORi - axitinib

Brief summary: Describe in patients with metastatic kidney cancer treatment modalities with the type sequences: TKI - mTORi - Axitinib or VEGF mAb - mTORi - Axitinib.


Eligibility criteria: Inclusion criteria:

* Patient with metastatic kidney cancer (all histological types)
* Male or female aged (e) of 18 or more
* Patient has been treated or under treatment with axitinib (Inlyta®) in the third line after the first line of targeted TKI therapy and after mTORi in 2nd line, or
* Patient receiving the treatment sequence VEGFmAb - mTORi - axitinib For living patients: patient informed and having given oral consent

Exclusion criteria:

* Patient who received more than one line of antiangiogenic therapy in the metastatic phase before initiation of treatment with axitinib (except patients in the study Pisces) Patient received a second line treatment with TKI Patient refused to participate in the study

Primary outcomes:
measure: Evolution of Kidney cancer
timeFrame: after surgery, up to 1 year]
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01697124: The Children in Action Feasibility Study
Official title: The Children in Action Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Motor Activity
Keywords: Physical activity
children
Head Start
SPARK-EC
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2012-10-02
Enrollment: 274
Sex: ALL
Minimum age (years): 3
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The Children in Action (CIA) program was a five month physical activity intervention. This intervention was a feasibility study with 3- to 5-year-olds enrolled in four Head Start centers. After baseline assessment, centers were matched by ethnicity and for number of participants and randomly assigned to either the intervention or the control condition. A total of 224 preschool children were randomly selected across the four centers. To evaluate the efficacy of the CIA intervention, the change in physical activity, gross motor skills and weight during the awake time and used mixed effect time-series regression models was compared. Observations did not show a statistical difference between intervention and control groups in physical activity level during the awake time, gross motor development or weight status. It was demonstrated that it is feasible to conduct the SPARK-EC curriculum among preschool children attending Head Start Centers but that an increased dose and/or longer intervention duration will be required to impact gross motor skills, weight status and physical activity levels during this critical early childhood development stage.


Eligibility criteria: Inclusion Criteria:

* 3-5 years old
* attends Head Start
* African-American
* Hispanic-American

Exclusion Criteria:

* older than 5 years old
* does not attend Head Start
* race/ethnicity other than African-American or Hispanic-American
* has a disability or handicap that would prevent them from participating in physical activities

Primary outcomes:
measure: Change from baseline in physical activity at post-intervention.
timeFrame: 8 months
Secondary outcomes:
measure: Change from baseline in gross motor skills at post intervention.
timeFrame: 8 months
measure: Body Mass Index
timeFrame: 8 months
Other outcomes:
Locations:
Study officials:
affiliation: Baylor College of Medicine
name: Theresa A Nicklas, DrPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06898424: Impact of Ketoflex 12/3 Diet on Early-to-Mid Stage Alzheimer's Progression
Official title: Effects of Concurrent Plant-Based Ketogenic Diet and Intermittent Fasting (Ketoflex 12/3) on the Clinical Progression of Early-to-Mid Stage Alzheimer's Dementia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Type Dementia
Alzheimer&#39;s Disease (AD)
Keywords: Alzheimer's Disease
Ketogenic Diet
Intermittent Fasting
Ketoflex 12/3
Cognitive Decline
Neurodegeneration
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2025-03-27
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study investigates the effects of the Ketoflex 12/3 diet on the clinical progression of early-to-mid stage Alzheimer's disease. The study evaluates cognitive function, metabolic changes, and overall health outcomes in participants following the Ketoflex 12/3 dietary protocol.


Eligibility criteria: Inclusion Criteria:

* Age between 50-85 years
* Clinical Dementia Rating (CDR) score of 0.5 or 1
* Diagnosis of Alzheimer's disease (AD) according to NINCDS-ADRDA criteria

Exclusion Criteria:

* Alcohol and/or substance dependence
* Diagnosis of chronic renal failure
* Diagnosis of another neuropsychiatric disorder
* Presence of amalgam dental fillings and/or failure to have them removed following the SMART protocol

Primary outcomes:
measure: Change in Cognitive Function as Measured by the MMSE Score
timeFrame: Baseline and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medipol Universitesi
Study officials:
affiliation: Medipol University
name: Lütfü Hanoğlu, Prof. MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02570724: HES Patch Versus Blood Patch
Official title: Clinical Effect and Cerebral Vasoconstriction Induced After Epidural Blood Patch Versus Epidural Hydroxyethyl Starch Patch in Patients With Headache Due to Intracranial Hypotension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intracranial Hypotension
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2015-10-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The injection of autologous blood Blood Patch (BP) into the epidural space is the standard treatment for headache associated with intracranial hypotension. It provokes cerebral vasoconstriction. It is cons-indicated in a number of situations (HIV positive, fever, sepsis, leukemia). The purpose of this study is to evaluate another technique using a patch made by injecting an epidural hydroxyethylstarch solution (HES 130, 0.4, 6%) instead of blood patch. This alternative technique is simple to implement and does not have some of the specific blood pressure contra-indications. The study aims at comparing the "Blood Patch" group versus the "HES Patch" in terms of clinical efficacy , tolerance, satisfaction of the anesthetist, ease of implementation and effect of the injection of epidural anesthesia on cerebral blood flow within 24 hours.


Eligibility criteria: Inclusion Criteria:

* Subjects older than 18 years.·
* Subjects with an intracranial hypertension syndrome secondary to an epidural, spinal or lumbar puncture (and therefore presumed iatrogenic) with a sub arachnoid space or subjects with intracranial hypertension syndrome of primitive origin requiring treatment with epidural Patch ·
* subjects with a temporal window of sufficient quality to carry out the transcranial Doppler ·
* Subjects haven read the informed consent, signed and dated prior to the start of any proceedings related to the tial·
* Subjects affiliated to health insurance·
* Subjects having been informed of the results of a prior medical consultation

Exclusion Criteria:

* Subjects with a cons-indication to an epidural Patch:
* blood disorders constitutional or acquired coagulation with platelets
* Subjects under treatment with curative doses of antiplatelet drugs or anticoagulants
* subjects under shock and / or hypovolemia
* subjects under generalized sepsis or at the puncture site
* any other cons-indication to performing an epidural

Primary outcomes:
measure: Variation of the pulsatility index (PI) of the middle cerebral artery transcranial Doppler
timeFrame: 36 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service Anesthésie Réanimation Chirurgicale Hôpitaux Universitaires de Strasbourg, 1 avenue Molière
state: Strasbourg Cedex
Study officials:
References: