louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04074304: Developing and Piloting a Multi-component Technology-based Care Intervention to Address Patient Symptoms and Caregiver Burden in Home Hospice. Phase 1.
Official title: Developing and Piloting a Multi-component Technology-based Care Intervention to Address Patient Symptoms and Caregiver Burden in Home Hospice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Home Hospice
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: Visiting Nurse Service of New York
name: National Institute on Aging (NIA)
First posted: 2019-08-30
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: With the growth of hospice, older adults have the opportunity to receive home-based care aimed at reducing suffering and focusing on quality of life at the end of life. While use of technology and educational videos has yet to be fully developed, structured, and evaluated in home hospice care, it has shown promise to improve care in other settings. Therefore, this study aims to develop and evaluate a multi-component technology-based care intervention, i.e., Improving Home hospice Management of End of life issues through technology (I-HoME), that focuses on assessing and addressing patient symptoms and caregiver burden in the home hospice setting through synchronous live video visits and educational videos. The aim of the first phase of the project is to employ an iterative user-centered design process to develop I-HoME for home hospice patients and their caregivers prior to implementation.


Eligibility criteria: Inclusion Criteria:

* Home hospice providers (N=10) and family caregivers (N=10) must be English speaking, 18 years of age or older, not blind, and either providing or receiving home hospice care. Home hospice patients (N=10) must be English speaking, 65 years of age or older, not blind, and enrolled in home hospice care.

Exclusion Criteria:

* Patients with a terminal diagnosis of dementia or patients who have cognitive impairment and unable to sign a written informed consent will be excluded.

Primary outcomes:
measure: Participants' experience using the intervention as measured by the I-HoME User-centered design questionnaire
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: The Visiting Nurse Service of New York
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Veerawat Phongtankuel, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01865604: Impact of tDCS on Cerebral Autoregulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Microangiopathy
CADASIL
Migraine With Aura
ICA Stenosis
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2013-05-31
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of the study is to investigate whether there is a polarity-specific influence of tDCS on cerebral vasomotor reactivity monitored by transcranial doppler sonography.


Eligibility criteria: Inclusion Criteria:

1. severe cerebral Microangiopathy
2. NOTCH3 carrier
3. Migraine with aura (IHS Classification ICHD-II)
4. Stenosis \>80%, ECST-Criteria

Exclusion Criteria:

* seizure disorder
* history of severe alcohol or drug abuse, psychiatric illness like severe depression, poor motivational capacity
* dementia

(1+2) history of stroke in past 3 months (3) migraine prophylaxis (4) contralateral stenosis \>50%,

Primary outcomes:
measure: Cerebral vasomotor reactivity assessed by transcranial Dopplersonography
timeFrame: on 3 days within 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Department of Neurology, Charité Universitätsmedizin Berlin
Study officials:
affiliation: Charite University, Berlin, Germany
name: Agnes Flöel, Prof. MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00551304: Native Kidney Denervation in Patients With End Stage Renal Disease
Official title: Native Kidney Denervation in Patients With End Stage Renal Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: End Stage Renal Disease
Lead sponsor: Medtronic Vascular
Sponsor class: INDUSTRY
First posted: 2007-10-30
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: To investigate the utility of renal denervation in the treatment of patients with End Stage Renal Disease (ESRD).


Eligibility criteria: Inclusion Criteria:

* adult \>= 18 years of age
* end stage renal disease, undergoing concurrent dialysis treatment
* poorly controlled blood pressure on at least 2 antihypertensive drugs
* agrees to have the study procedure(s) performed and additional procedures and evaluations, including interventions and follow up visits
* competent and willing to provide written, informed consent to participate in this clinical study.

Exclusion Criteria:

* renal arterial abnormalities
* myocardial infarction, unstable angina pectoris, or a cerebrovascular accident within six (6) months
* hemodynamically significant valvular heart disease
* implantable cardioverter defibrillator (ICD) or pacemaker
* respiratory support.
* pregnant, nursing or planning to be pregnant
* other

Primary outcomes:
measure: To provide confirmation that renal denervation in ESRD patients is safe and feasible.
Secondary outcomes:
measure: To provide evidence of denervation, indication of physiologic response, and assess device performance.
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: The Alfred Hospital
state: Victoria
city: Cracow
country: Poland
facility: John Paull II Hosptial
Study officials:
affiliation: The Alfred
name: Markus Schlaich, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schlaich MP, Hering D, Sobotka PA, Krum H, Esler MD. Renal denervation in human hypertension: mechanisms, current findings, and future prospects. Curr Hypertens Rep. 2012 Jun;14(3):247-53. doi: 10.1007/s11906-012-0264-9.
citation: Hering D, Esler MD, Krum H, Mahfoud F, Bohm M, Sobotka PA, Schlaich MP. Recent advances in the treatment of hypertension. Expert Rev Cardiovasc Ther. 2011 Jun;9(6):729-44. doi: 10.1586/erc.11.71.
citation: Schlaich MP, Sobotka PA, Krum H, Whitbourn R, Walton A, Esler MD. Renal denervation as a therapeutic approach for hypertension: novel implications for an old concept. Hypertension. 2009 Dec;54(6):1195-201. doi: 10.1161/HYPERTENSIONAHA.109.138610. Epub 2009 Oct 12. No abstract available.
Clinical trial NCT06557304: The Real World Study of BTK Inhibitor in the Treatment of Chronic Lymphocytic Leukemia in China
Official title: This is a Multicenter, Retrospective Real-world Study of BTK Inhibitor in the Treatment of Chronic Lymphocytic Leukemia in China
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: CLL
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2024-08-16
Enrollment: 1000
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: Investigators participating in this observational study should include all patients with CLL who initiated treatment with BTK inhibitor over the period from Dec. 1st, 2017 to the present, regardless of the treatment status at the time of inclusion. Thus, at the time of enrolment and retrospective data collection, patients may still be on treatment or have stopped treatment for any reason.

Brief summary: This is a Multicenter, Retrospective Real-world Study of Zanubrutinib in the Treatment of Chronic Lymphocytic Leukemia in China


Eligibility criteria: Inclusion Criteria:

1. Patients aged ≥18 years old
2. Must have a confirmed diagnosis of Chronic Lymphocytic Leukemia (CLL) requiring treatment (iwCLL \[International Workshop on Chronic Lymphocytic Leukemia\] criteria)；
3. Treatment-naïve OR Refractory Recurrence CLL patients who were initiated on BTK inhibitor;
4. Prior or current use of BTK inhibitor for ≥3 months
5. At least one follow-up was recorded during BTK inhibitor treatment

Primary outcomes:
measure: Overall Survival
timeFrame: up to five years
Secondary outcomes:
measure: Time to Next Therapy (TTNT)
timeFrame: up to two years
measure: Adverse Events
timeFrame: up to five years
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05666401: Effect of Duration and Follicle Diameter During Oocyte Pick up on Embryological Parameters
Official title: Does Follicle Diameter and Total Duration Spent for Oocyte Pick up Has Any Effect on Embryological Parameters and Clinical Pregnancy Rates
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Follicle Size
Embryologic Parameters
Duration
Keywords: follicle
dimension
IVF
embryological parameters
duration
Lead sponsor: Eurofertil IVF Health Center
Sponsor class: OTHER
First posted: 2022-12-27
Enrollment: 291
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Couples attending to our clinic for IVF - ICSI without history of RIF and severe male factor

Brief summary: Investigators aim to investigate if the time spent for smaller follicles worth to deal with. The difference between follicle groups are recorded for embryological parameters. Results will be analysed for yielding transfer embryo and pregnancy rates between groups.

Detailed description: There are papers about follicle dimensions and volumes studying their effect on embryologic parameters. But most of these studies are far from practical approach and are not easily applicable, such as 3D volumetric measurement is not feasible for most of the clinics. Also one of the points important for us it to evaluate the duration of the procedure and the possible positive effect of shortening the duration for better results. Investigators plan to measure the follicles just before puncture and arrange two groups. Group 1,follicles with diameter of 17 mm and more, and group 2 follicles between14-17 mm. Maturation, fertilization, cleavage characteristics are recorded. The source of chosen transfer embryo and crio-preserved embryos per cycle is also point of interest.

Eligibility criteria: Inclusion Criteria:

* 20-40 year old women

Exclusion Criteria:

* History of recurrent implantation failure (RIF)
* Known chromosomal abnormality
* Severe male factor and azospermia

Primary outcomes:
measure: transfer embryo
timeFrame: 5 to 7 days
Secondary outcomes:
measure: clinical pregnancy
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Bursa Eurofertil IVF center
city: Bursa
country: Turkey
facility: Eurofertil IVF center
Study officials:
affiliation: bursa Eurofertil IVF center
name: gercek aydin
role: STUDY_DIRECTOR
References:
Clinical trial NCT05182801: Banana Flower Extract in the Efficacy Verification Program of Hair and Body Health Care
Official title: Banana Flower Extract in the Efficacy Verification Program of Hair and Body Health Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hair Loss
Lead sponsor: TCI Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-01-10
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: To assess Banana flower extract supplement on hair and body health care


Eligibility criteria: Inclusion Criteria:

* Healthy adults aged above 20 years old

Exclusion Criteria:

* Subject who is not willing to participate in this study.
* Patients with diseases of the skin, liver, kidney.
* Subjects who have known cosmetic, drug or food allergies, difficulty in digestive tract absorption or disorder.
* Female who is pregnant or nursing or planning to become pregnant during the course of the study.
* The students taught by the PI.
* Subjects who have wounds on the scalp and subjects who have used drugs to treat the scalp, received hair transplants or other scalp treatments within six months

Primary outcomes:
measure: The change of hair loss amount
timeFrame: Change from Baseline hair loss amount at 12 weeks
measure: The change of hair density
timeFrame: Change from Baseline hair density at 12 weeks
measure: The change of hair follicle strength
timeFrame: Change from Baseline hair follicle strength at 12 weeks
Secondary outcomes:
measure: The change of scalp gloss
timeFrame: Change from Baseline scalp gloss at 12 weeks
measure: The change of scalp redness
timeFrame: Change from Baseline scalp redness at 12 weeks
measure: The change of scalp health
timeFrame: Change from Baseline scalp health at 12 weeks
measure: The change of hair diameter
timeFrame: Change from Baseline hair diameter at 12 weeks
measure: The change of dihydrotestosterone of blood
timeFrame: Change from Baseline hair diameter at 12 weeks
measure: The change of testosterone of blood
timeFrame: Change from Baseline testosterone at 12 weeks
measure: The change of SRD5A1 gene expression of blood
timeFrame: Change from Baseline SRD5A1 gene expression at 12 weeks
measure: The change of AR gene expression of blood
timeFrame: Change from Baseline AR gene expression at 12 weeks
measure: The change of TGF-β gene expression of blood
timeFrame: Change from Baseline TGF-β gene expression at 12 weeks
measure: The change of IGF-1 gene expression of blood
timeFrame: Change from Baseline IGF-1 gene expression at 12 weeks
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: Chia Nan University of Pharmacy ＆ Science
Study officials:
References:
Clinical trial NCT05078801: Endoscopic Versus Radiologic Biliary Drainage for Perihilar Malignant Obstruction
Official title: Comparison of Efficacy and Safety of Endoscopic Biliary Drainage and Percutaneous Transhepatic Biliary Drainage for the Management of Perihilar Malignant Biliary Obstruction: a Monocentric Retrospective Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Perihilar Cholangiocarcinoma
Jaundice, Obstructive
Keywords: ERCP
EUS-guided biliary drainage
Percutaneous transhepatic biliary drainage
hilar obstruction
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2021-10-15
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: all adults patients hospitalized in Nancy University Hospital with perihilar biliary malignant obstruction who underwent either endoscopic or percutaneous approach for biliary drainage.

Brief summary: This retrospective monocentric study aims at comparing multimodality endoscopic biliary drainage versus percutaneous radiologic biliary drainage in case of perihilar malignant obstruction.

Data from patients admitted in the Nancy University Hospital, France, between january 2016 and march 2022 with jaundice and perihilar obstruction will be retrospectively collected.


Eligibility criteria: Inclusion Criteria:

* hospitalization between january 2006 and march 2022
* perihilar obstruction
* indication of biliary drainage

Exclusion Criteria:

* distal biliary obstruction
* perihilar obstruction without indication of biliary drainage

Primary outcomes:
measure: Bilirubin serum level
timeFrame: 7 days
Secondary outcomes:
measure: Complications
timeFrame: 16 years
measure: number of procedures
timeFrame: 16 years
measure: bilirubin serum level on day 30 and on day 90
timeFrame: 90 days
measure: median survival in months
timeFrame: 16 years
measure: number of unplanned hospital admissions
timeFrame: 16 years
Other outcomes:
Locations:
city: Nancy
country: France
facility: Nancy Hospital Center
Study officials:
References:
Clinical trial NCT00920101: Anti-inflammatory Effect of Atorvastatin in Atherosclerotic Plaques Assessed by FDG-PET Imaging
Official title: Effect of Atorvastatin on Inflammatory Atherosclerotic Plaques Assessed by FDG-PET Imaging
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Atherosclerosis
Inflammation
Keywords: atherosclerotic plaques
hypercholesterolemia
HMG-CoA reductase inhibitor
statin
lipid-lowering therapy
Lead sponsor: National Defense Medical College, Japan
Sponsor class: OTHER
First posted: 2009-06-15
Enrollment: 30
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: The purpose of this study is to determine whether HMG-CoA reductase inhibitor, atorvastatin attenuates inflammation in atherosclerotic plaques detected by 18F-fluorodeoxyglucose(FDG) PET.


Eligibility criteria: Inclusion Criteria:

* Subjects with accumulation of FDG-PET in carotid artery or aorta

Exclusion Criteria:

* LDL cholesterol level (calculated by using Friedewald formula) higher than 180 mg/dl or less than 120 mg/dl
* subjects currently taking HMG CoA-reductase (Statins) or fibrates
* symptomatic coronary artery diseases
* symptomatic cerebrovascular diseases
* subjects suffered from myocardial infarction or stroke within 6 months
* subjects underwent percutaneous vascular interventions or vascular operations within 6 months
* diabetic patients with poor glycemic control (HbA1c\>8.5)
* hypertensive patients with poor blood pressure control
* subjects with neoplasms
* subjects with systemic inflammatory diseases

Primary outcomes:
measure: Standardized uptake value (SUV) of 18-FDG detected in carotid/aortic atherosclerotic plaques
timeFrame: Baseline and 3 months after intervention
Secondary outcomes:
measure: Flow-mediated vasodilation of brachial artery determined by ultrasonography
timeFrame: Baseline and 3 months after intervention
measure: Serum markers for inflammation such as high-sensitive CRP, IL-6 or soluble ICAM-1
timeFrame: Baseline and 3 months after intervention
measure: Serum and urine markers for anti- or pro-oxidant stress such as oxidized LDL or 8-Hydroxydeoxyguanosine
timeFrame: Baseline and 3 months after intervention
measure: Max-intima-media thickness (Max-IMT), Mean-IMT and plaque score determined by carotid artery ultrasonography
timeFrame: Baseline and 3 months after intervention
measure: Serum lipids such as total cholesterol, LDL-cholesterol, HDL-cholesterol, RLP-cholesterol and triglycerides
timeFrame: Baseline and 3 months after intervention
Other outcomes:
Locations:
city: Tokotozawa
country: Japan
facility: National Defense medical College
state: Saitama
Study officials:
affiliation: National Defense Medical College
name: Katsunori Ikewaki
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03946501: Clinical Research and Data Collection During the Investigation: Influence of a Dedicated Staff
Official title: Clinical Research and Data Collection During the Investigation: Influence of a Dedicated Staff
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Clinical Research Inclusion
Keywords: missing data
clinical research
clinical research assistant
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2019-05-10
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: clinical research visit performed in Reims university hospital, with or without the help of a clinical research assistant

Brief summary: The aim of the study was to evaluate the interest of the recourse of a staff dedicated as CRA to data collection in clinical research

Detailed description: Objectives of clinical studies are notably to evaluate new therapies, to improve diagnostic techniques, to make medico-economic decisions and to enrich scientific knowledge. Clinical studies findings can influence medical practice, or even motivate decisions by public health authorities. The rigor in their behavior is therefore an imperative to respect.

Thus, the quality of the data collected is essential. However, even if the reliability of the clinical data is guaranteed by the monitoring, the completeness of the data remains exceptional.

The increase of data required in clinical studies has led to the emergence of a specialized staff to assist investigators: the clinical research assistants. With dedicated time and specialization in data collection, they facilitate the conduct of clinical studies. However, this data collection aid has not been evaluated.

Eligibility criteria: Inclusion Criteria:

- clinical research visit performed in Reims university hospital between January 2010 and January 2015

Primary outcomes:
measure: Missing data
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Reims
country: France
facility: Damien JOLLY
Study officials:
References:
citation: Ghenim S, Feron T, Barbe C, Wolak-Thierry A, Jolly D. [Clinical research and data collection during the investigation: Influence of a dedicated staff]. Therapie. 2018 May-Jun;73(3):267-272. doi: 10.1016/j.therap.2017.10.003. Epub 2017 Nov 11. French.