louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00006433: Phase I/II Trial of Doxil and Hyperthermia for Breast Cancer Patients With Chest Wall Recurrence or Stage IV Disease With Locally Advanced Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: National Center for Research Resources (NCRR)
Sponsor class: NIH
First posted: 2000-11-06
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: Purpose: The purpose of this protocol is to evaluate the combination of Doxil chemotherapy and heat treatment for recurrent breast cancer located on the chestwall following mastectomy. This protocol also includes patients with metastatic breast cancer who have not had mastectomy but have advanced tumor remaining within the breast. Doxil is the drug adriamycin (also called doxorubicin) encapsulated in liposomes, which coats the drug with a small amount of lipid (fat). This chemotherapy is in a newer form which can be better delivered to the tumor tissue without causing as much systemic toxicity. We are combining heat treatment with this drug in an effort to further increase the delivery of drug to the tumor, which may give an increased tumor response.

Methods: The patients will be treated with chemotherapy followed by heat treatment. This will be given for 6 cycles approximately every 4 weeks. For the first cycle patients will need to be hospitalized 3 days for measurement of blood levels of drug as well as some additional radiology studies which will help us to determine whether the drug is preferentially distributed within tumor.


Eligibility criteria: Inclusion Criteria:

* Patients with recurrent or metastatic breast cancer

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Radiation Oncology, Duke University Medical Center
state: North Carolina
Study officials:
name: Leonard R. Prosnitz, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05235633: ADLs at the End of Acute Treatment for Childhood Leukemia and Non-Hodgkin Lymphoma
Official title: Activities of Daily Living at the End of Acute Treatment for Acute Leukemia or Non-Hodgkin Lymphona During Childhood and Adolescence
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Childhood Cancer
Keywords: Activities of daily living
Leukemia
Non-Hodgkin Lymphoma
Physical activity
Motor performance
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
Collaborators: name: Ludwig-Maximilians - University of Munich
First posted: 2022-02-11
Enrollment: 20
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study polulation will be recruited at the Oncology and Hematology Day Hospital at the Dr. von Hauner Children's Hospital of the University of Munich.

Brief summary: Reduced activity levels and reduced muscular strength could severely impair the activities of daily living (ADLs) in pediatric leukemia and Non-Hodgkin lymphoma patients. Increased muscle strength is associated with improved accomplishment of ADLs and consequently greatest possible normality, autonomy and mobility. This associated investigation to the study with the ClinicalTrials.gov Identifier NCT03934060 aims at collecting data in a comparison cohort with respect to ADLs in children and adolescents who did not receive a standardized strenght training intervention during the whole course of treatment.


Eligibility criteria: Inclusion Criteria:

* Children and adolescents aged 4-18 years
* At the end of acute treament for leukemia or non-Hodgkin lymphoma
* Diagnosed and/or treated at the Dr. von Hauner Children's Hospital, University of Munich
* Informed consent as documented by signature

Exclusion Criteria:

* Medical contraindication to perform this unique test battery (e.g., acute bleeding risk, pain, nausea, acute orthopedic impairments)
* Inability to follow study procedures (e.g., language problems, mental retardation)

Primary outcomes:
measure: Score of the Activities Scale for Kids - performance version
timeFrame: During the procedure
Secondary outcomes:
measure: Motor Performance
timeFrame: During the procedure
measure: Performance in a Parkour in Activities of Daily Living
timeFrame: During the procedure
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Kinderklinik München Schwabing, TUM School of Medicine, Department of Paediatrics and Children's Cancer Research Center, Technical University of Munich, Germany
Study officials:
affiliation: Kinderklinik München Schwabing TUM School of Medicine, Department of Pediatrics and Children's Cancer Research Center, Technical University of Munich
name: Sabine Kesting
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04350333: Efficacy of Digital CBT-I Intervention During Pregnancy
Official title: Efficacy of Digital Cognitive Behavioral Therapy for Insomnia (CBT-I) Intervention During Pregnancy in Prevention of Post-partum Depression: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Insomnia in Pregnancy
Lead sponsor: University of Rome G. Marconi
Sponsor class: OTHER
First posted: 2020-04-17
Enrollment: 114
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This randomized controlled trial aims to evaluate the efficacy of Cognitive Behavioral Therapy for Insomnia in pregnant women. Particularly, this study aim to explore the effect of this intervention in ameliorating insomnia symptoms and in preventing post-partum depression disorder. The experimental intervention is a digital CBT-I and the control intervention group is an assertive communication training. Both interventions include a screening phase and will be delivered in a digital way and will be composed of 5 sessions. Furthermore, both interventions protocol include a baseline, half time and follow up assessments.


Eligibility criteria: Inclusion Criteria:

* Healthy pregnancy
* Women that not consume nicotine or alcool
* BMI \< 30
* Women who complains of insomnia or bad sleep quality

Exclusion Criteria:

* BMI\> 30
* Complicated pregnancy
* Women who consume nicotine or alcool

Primary outcomes:
measure: Depression
timeFrame: Follow up: 2 weeks post partum
measure: Depression
timeFrame: Follow up: 3 months post partum
measure: Depression
timeFrame: Follow up: 6 months post partum
measure: Anxiety
timeFrame: Follow up: 2 weeks post partum
measure: Anxiety
timeFrame: Follow up: 3 months post partum
measure: Anxiety
timeFrame: Follow up: 6 months post partum
Secondary outcomes:
measure: Sleep pattern (sleep onset latency; total sleep time; wake after sleep onset; sleep efficiency)
timeFrame: Post intervention: after 5 weeks from the start of intervention
measure: insomnia symptoms
timeFrame: Post intervention: after 5 weeks from the start of intervention
measure: Emotion regulation
timeFrame: Post intervention: after 5 weeks from the start of intervention
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00378833: Tolerability of MK0524A Versus Niacin Extended-Release (0524A-054)
Official title: A Worldwide, Multicenter, Double-Blind, Parallel Study to Evaluate the Tolerability of MK0524A Versus Niacin Extended-Release
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypercholesterolemia
Hyperlipidemia
Keywords: Primary Hypercholesterolemia or Mixed Hyperlipidemia
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2006-09-21
Enrollment: 1300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a 16-week clinical trial in lipid clinic patients for whom niacin therapy is appropriate to evaluate the tolerability of MK0524A versus niacin extended-release. There will be 6 scheduled clinic visits and 2 treatment groups.


Eligibility criteria: Inclusion Criteria:

* Patient is an appropriate candidate for niacin therapy (at risk for heart disease) and triglycerides \< 500 mg/dL

Exclusion Criteria:

* Patients with a history of any cardiovascular event directly linked to atherosclerosis with a low density lipoprotein-cholesterol (LDL-C) \>/= 130 mg/dL and/or not on a statin
* Patients with diabetes and LDL-C \>/= 130 mg/dL. Patients with \>/= 2 heart disease risk factors and LDL-C \>/= 160 mg/dL.
* Patients who have had a cardiovascular event (e.g., heart attack, stroke) within the previous 3 months.

Primary outcomes:
measure: Global Flushing Severity Score (GFSS) over 16 weeks
Secondary outcomes:
measure: Safety/tolerability
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Maccubbin D, Koren MJ, Davidson M, Gavish D, Pasternak RC, Macdonell G, Mallick M, Sisk CM, Paolini JF, Mitchel Y. Flushing profile of extended-release niacin/laropiprant versus gradually titrated niacin extended-release in patients with dyslipidemia with and without ischemic cardiovascular disease. Am J Cardiol. 2009 Jul 1;104(1):74-81. doi: 10.1016/j.amjcard.2009.02.047.
Clinical trial NCT05883033: VAC and Conventional Dressing in the Healing Process of Necrotizing Fasciitis
Official title: Comparative Study Between Vacuum Assisted Closure (VAC) and Conventional Dressing in the Healing Process of Necrotizing Fasciitis After Surgical Debridement.. Clinical and Laboratory Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Necrotizing Fascitis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-05-31
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Find out the best management of Necrotizing Fasciitis after surgical debridement

Detailed description: Necrotizing fasciitis is a life-threatening condition that can occur as a result of trauma or foreign bodies in surgical wounds as well as idiopathically. Necrotizing fasciitis is characterized by a progressive infection in fascial planes with necrosis of the subcutaneous tissue. Necrotizing fasciitis affects the extremities more frequently than central areas. Risk factors for necrotizing fasciitis include diabetes mellitus, trauma wound infections, decubitus ulcers, alcoholism, carcinoma, peripheral vascular disease, smoking, and intravenous drug abuse. A varieties of micro-organisms, including gram-positive group A streptococcus, haemolytic streptococci, and staphylococcus aureus; gram-negative Enterobacteriaceae, Escherichia coli, Klebsiella spp., and Proteus spp.; anaerobes including Peptostreptococcus, Clostridium, and Pacteroides; and fungi such as Candida and acid-fast bacteria have all been implicated in the pathogenesis of Necrotizing fasciitis.

Necrotizing fasciitis is a surgical emergency for detoxification by debridement with good antibiotic coverage. It has mortality rate reaching 20-30% , this mortality rate is high and requires prompt diagnosis, antibiotic treatment and extensive necrosectomy up to intensive care units admission in some cases, the aim of our prospective analysis is to assess with a hypothesis-generating and exploratory purpose the possible role of VAC versus ordinary dressings in the wound therapy of Necrotizing Fasciitis in terms of expected time for wound closure and survival rate.

Eligibility criteria: Inclusion Criteria:

* Immunocompromised patients such as; diabetic, HIV and leukaemia.

And other chronic debilitating diseases.

Exclusion Criteria:

* Necrotizing Fasciitis of Head and neck and upper limbs.

Primary outcomes:
measure: Hospital staying length
timeFrame: Baseline
Secondary outcomes:
measure: Required other stages of debridement
timeFrame: Baseline
measure: Expected closure of the wound by secondary intention
timeFrame: Baseline
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University
Study officials:
References:
citation: Zhang R, Zhang Y, Hou L, Yan C. Vacuum-assisted closure versus conventional dressing in necrotizing fasciitis: a systematic review and meta-analysis. J Orthop Surg Res. 2023 Feb 4;18(1):85. doi: 10.1186/s13018-023-03561-7.
Clinical trial NCT04351633: Psychological Impact of Quarantine in Osteoporosis Patient During COVID-19 Outbreak
Official title: Psychological Impact of Quarantine in Osteoporosis Patient During COVID-19 Outbreak
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sars-CoV2
Osteoporosis
Keywords: Psychological impact
COVID-19
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2020-04-17
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: FAMILY_BASED
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: osteoporosis patient will be interviewed par internet questionnaire (patient association / AFLAR)

Brief summary: In the context of quarantine with COVID-19, we wish to study the experience and psychological impact in adult patients living with osteoporosis.


Eligibility criteria: Inclusion Criteria:

* Patient with osteoporosis
* Patient in confinement
* Patient with sufficient understanding of the French language

Exclusion Criteria:

* Non adult patient
* patient without quarantine

Primary outcomes:
measure: percentage of patient with feeling of disabilities
timeFrame: maximum 1 week from baseline on
Secondary outcomes:
Other outcomes:
Locations:
city: Lille
country: France
facility: Hopital Roger Salengro, CHU Lille
Study officials:
affiliation: University Hospital, Lille
name: Bernard Cortet, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06332833: Availability of Venous Conduits in Patients With Varicose Veins for Arterial Bypass Surgery
Official title: Availability of Venous Conduits in Patients With Varicose Veins for Arterial Bypass Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Varicose Veins
Peripheral Arterial Disease
Keywords: varicose veins
Peripheral Arterial Disease
phlebectomy
Lead sponsor: Pirogov Russian National Research Medical University
Sponsor class: OTHER
First posted: 2024-03-27
Enrollment: 285
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with PAD having superficial femoral artery (SFA) occlusion.

Brief summary: Patients with PAD having superficial femoral artery (SFA) occlusion were consecutively enrolled. Demographic data and medical history were taken. Physical examination and duplex ultrasound were performed.

Detailed description: Patients with PAD having superficial femoral artery (SFA) occlusion were consecutively enrolled. Demographic data and medical history were taken. Physical examination and duplex ultrasound were performed. The investigators registered presence of varicose veins, type of previous invasive procedure and availability of saphenous trunks as possible grafts

Eligibility criteria: Inclusion Criteria:

* Older than 18 Years

Exclusion Criteria:

* Those unwilling to sign an informed consent were also included.

Primary outcomes:
measure: availability of saphenous trunks as possible grafts
timeFrame: at the moment of inclusion
Secondary outcomes:
measure: presence of varicose veins
timeFrame: at the moment of inclusion
measure: type of previous invasive procedure
timeFrame: at the moment of inclusion
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Veronika Golovina
state: Pirogov Russian National Research Medical University
Study officials:
References:
Clinical trial NCT06417333: A Smart-wrist Band Connected Mobile Application for the Assessment and Management of Dementia Symptoms
Official title: A Smart-wrist Band Connected Mobile Application for the Assessment and Management of Dementia Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia, Mild
Keywords: dementia health data fitness tracking
Lead sponsor: Muğla Sıtkı Koçman University
Sponsor class: OTHER
First posted: 2024-05-16
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: 2 15 people groups were distributes wristbands during a 6 month span
Primary purpose: PREVENTION

Brief summary: In this study, we developed a mobile application that will enable caregivers to continuously monitor the vital health, medication, activity, and location of the patients with MCI with a smart wristband while enabling them caregivers to track the progress of the disease by a machine learning model that predicts MMSE of the patient using speech

Detailed description: 3-month vital health data collection has been performed on 30 participants who are over 60 years old via smart fitness wristbands distributed to them. A mobile application has been developed that caregivers can register their patients, wristbands and allow them to monitor their health data along with their location. medication and activities while synchronizing data anonymously to the application database.

The data collection has been performed with relatively cheap, simple Xiaomi MI Band 7 wristbands that track only HR, RHR, sleep, steps and move minutes due to reasonable price and light weight and easy wearability of these devices.

Mobile application synchronizes data from wristband to application servers continuously using Google Fit services that synchronize with device software. This made it possible for the patient's data to still be collected when he or she is not using any of them.

MMSE scores of patients were taken at the beginning and at the end of the 3 month period to correlate scores with the collected aggregated health data and patient information

Eligibility criteria: Inclusion Criteria:

* Older patients who are willing to wear a smart wristband and have an Android smart phone

Exclusion Criteria:

-

Primary outcomes:
measure: Each participant's written Mini Mental State Examination (MMSE) score was taken in the first and last week of data collection period
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mugla
country: Turkey
facility: Mugla Sitki Kocman University - Dementia Clinic
Study officials:
affiliation: Head of The Bioinformatics Department
name: Tugba Suzek, Dr.
role: STUDY_CHAIR
References:
Clinical trial NCT06484933: Risk Management in Primary Care
Official title: Assessing Risk Management in Primary Care Teams
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Primary Care
Keywords: Primary care
Risk management
Teamwork
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2024-07-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care organizations in France

Brief summary: The proposed research is a prospective, non-comparative study based on a qualitative method, comprising a literature review followed by 2 successive series of Focus Groups with users and healthcare professionals of primary care in the French AURA region. The 2 Focus Group phases will make it possible to :

* propose an operational definition of the notion of a professional team in primary care (validation by consensus between the participants of the first 4 Focus Groups based on the definitions in the literature)
* describe the ways in which risks are managed in primary care teams (qualitative analysis of the contributions made by the participants in the next 12 Focus Groups organized in 12 primary care teams)


Eligibility criteria: Inclusion Criteria:

Healthcare professional

* Healthcare professional over 18 years of age, registered with the professional association on which he/she depends and holding an RPPS identification number with care activity as part of a coordinated practice, within a legally formalised care team working on a territorial health project, or care activity within a care team that is not legally formalized but defined as an entity bringing together ≥ 4 different professionals to care for the same patient.
* Most care provided on an outpatient basis
* Care activity in the AURA region
* Agreement to participate in the focus group Users
* Any user of the healthcare system over the age of 18
* Consulting a healthcare professional from a team included in the research
* Agreement to participate in the focus group

Exclusion Criteria:

Healthcare professional

* Primary care healthcare professional with a specific exclusive practice that does not form part of the overall management of a patient (e.g. homeopathy, mesotherapy, acupuncture, etc.) Users
* Persons deprived of their liberty by a judicial or administrative decision
* Adults under legal protection (guardianship, curatorship)
* Persons not affiliated to a social security scheme or beneficiaries of a similar scheme

Primary outcomes:
measure: Operational definition of the notion of a professional team in primary care in the France, by means of focus groups and validation by consensus.
timeFrame: up to 23 months
Secondary outcomes:
Other outcomes:
Locations:
city: Oullins
country: France
facility: Cabinet Medical
Study officials:
References:
Clinical trial NCT00553033: Laparoscopic Liver Resection
Official title: Prospective Evaluation of Laparoscopic Liver Resection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Tumors
Keywords: Patients must be candidable to liver resection
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2007-11-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients udergoing liver resection for benign or malignant tumors

Brief summary: The aim of this study is to evaluate the feasibility and safety of laparoscopic liver surgery.

Detailed description: Perioperative course of patients undergoing liver resection is evaluated.

Eligibility criteria: Inclusion Criteria:

* benign or malignant tumors
* tumor size less than 12 cm

Exclusion Criteria:

* Operations that required laparotomic procedures

Primary outcomes:
measure: Perioperative Morbidity and mortality
timeFrame: Perioperative
Secondary outcomes:
measure: Patient satisfation
timeFrame: Perioperative
measure: Patients satisfaction
timeFrame: Postoperative
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Department of Surgery - Liver Unit, Scientific Institute San Raffaele
Study officials:
affiliation: Department of Surgery - Liver Unit, Scientific Institute San Raffaele
name: Luca Aldrighetti, M.D PhD
role: STUDY_DIRECTOR
References:
citation: Aldrighetti L, Pulitano C, Catena M, Arru M, Guzzetti E, Casati M, Comotti L, Ferla G. A prospective evaluation of laparoscopic versus open left lateral hepatic sectionectomy. J Gastrointest Surg. 2008 Mar;12(3):457-62. doi: 10.1007/s11605-007-0244-6. Epub 2007 Aug 14.