louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04496375: An Evaluation of Patients Access to Their Electronic Medical Records Via the IPC Connect Application
Official title: An Evaluation of Patients Access to Their Electronic Medical Records Via the IPC Connect Application
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Solid Tumor
Hematologic Malignancy
Keywords: Electronic Medical Records
Patients anxiety
Lead sponsor: Institut Paoli-Calmettes
Sponsor class: OTHER
First posted: 2020-08-03
Enrollment: 8000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All outpatients with an solid tumor or an hematologic malignancy who will attend Institut Paoli-Calmettes Outpatients clinic during 1 months

Brief summary: The aim of our study is to investigate the effect of providing patients access to their electronic medical records Via the IPC Connect Application on their A Survey will be proposed to all outpatients with a solid or hematologic malignancy who will attend an appointement at Institut Paoli Calmettes clinic.

Data will be collected during a 1-month period. The auto-questionnaire will be composed of 31 questions addressed to all patients, 17 questions will be specifically addressed to patients using IPC connect application and 7 questions will be addressed to patients who do not use the application.


Eligibility criteria: Inclusion Criteria:

* Man or woman, age\> 18 Years
* Solid tumor or hematologic malignancy
* Patient attending an appointment at Institut Paoli Calmettes
* Non-opposition

Exclusion Criteria:

* emergency, Vulnerable person or unable to provide informed consent
* First appointment at Institut Paoli Calmettes

Primary outcomes:
measure: Impact of Patients Access to Their Electronic Medical Records Via the IPC Connect Application on patients anxiety level
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Institut Paoli-Calmettes
name: Gwenaelle Gravis
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04727775: Antiviral Drugs on the Treatment of SARS-CoV-2
Official title: A Retrospective Study of the Effect of Antiviral Drugs on the Treatment of SARS-CoV-2 COVID19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Complication of Medical Care
Pneumonia, Viral
Lead sponsor: Astana Medical University
Sponsor class: OTHER
First posted: 2021-01-27
Enrollment: 150
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: patients with previous covid 19 pneumonia

Brief summary: Retrospective Non-Randomized Analytical Cohort Study of Completed SARS-CoV2 COVID19 Cases

Detailed description: Analyzing the case histories of patients with SARS-CoV2 COVID19 infection and the impact on the outcomes of prescribing antiviral drugs

Eligibility criteria: Inclusion Criteria:

main group

* Patients with COVID19 with medium and easy condition disease
* take favipiravir/remdisivir control group
* Patients with COVID19 with medium and easy condition disease
* not take favipiravir/remdisivir

Exclusion Criteria:

* patients younger 18
* severe conditionis

Primary outcomes:
measure: Outcome without comlications
timeFrame: 14 days
Secondary outcomes:
measure: Heart rate
timeFrame: 14 days
measure: SpO2
timeFrame: 14 days
measure: Blood pressure
timeFrame: 14 days
measure: Respiratory rate
timeFrame: 14 days
Other outcomes:
Locations:
city: Astana
country: Kazakhstan
facility: Aidos Konkaev
city: Semey
country: Kazakhstan
facility: Semey Medical University
Study officials:
References:
Clinical trial NCT02353975: Effect of a High-fat Meal on the Pharmacokinetics of SHR3824 and Mass Balance Study in Healthy Subjects
Official title: An Open Label, Randomized, Two-period, Crossover Study to Assess the Effect of Food on SHR3824 and Mass Balance Study in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes
Keywords: SHR3824
food effect
mass
balance
Phase I
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-02-03
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This open-label, randomized, two-period, two-treatment (single doses of 10 mg SHR3824 fasted or fed), crossover study was conducted to evaluate the effect of a high-fat meal on the pharmacokinetics of SHR3824 and mass balance study in 12 healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy.
* BMI 18-25 kg/m2.

Exclusion Criteria:

* History of clinically significant illness.
* History of alcohol or drug abuse.

Primary outcomes:
measure: The maximum plasma concentration (Cmax) of SHR3824
timeFrame: Day 1-4 on visit 2 and visit 3
measure: The area under the plasma concentration-time curve (AUC) of SHR3824
timeFrame: Day 1-4 on visit 2 and visit 3
measure: The accumulative excretion rate of SHR3824 and its metabolites in urine and feces
timeFrame: Day 1-4 on visit 2 and visit 3
Secondary outcomes:
measure: The number of volunteers with adverse events as a measure of safety and tolerability.
timeFrame: Up to Day 12
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00952770: Effect of Statins on the Radial Intima-media Thickness After Transradial Angioplasty
Official title: Effect of Statins on the Progression of the Intima-media Thickness of the Radial Artery After Radial Angioplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Coronary Artery Disease
Keywords: Coronary artery disease
Coronary intervention
intima-media thickness
Lead sponsor: Chungnam National University
Sponsor class: OTHER
First posted: 2009-08-06
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The first event of the atherosclerotic plaque formation is the accumulation of the low density lipoprotein-cholesterol (LDL-cholesterol) in to the intima of the arterial wall. After accumulation of the LDL-cholesterol, the oxidation of the LDL-cholesterol particles and recruitment of monocytes to the intima and media are the next steps. The thickening of intima-media thickness (IMT) is resulted from these initial events. The IMT can be easily measured by high-resolution ultrasonography in various arteries including carotid, brachial and radial arteries. The increased carotid IMT can be used as a non-invasive independent parameter indicating increased cardiovascular mortality. Some investigators reported increased radial IMT is associated with increased early failure of the radiocephalic arteriovenous fistula in the hemodialysis patients. Moreover, radial IMT is increased in patients underwent radial artery intervention because of denudation injury of the radial artery. Recently, the use of statin can halt the progression of the carotid IMT progression. However, it is unknown that the use of statin can prevent the progression of radial IMT after the transradial coronary intervention. The investigators want to evaluate the effect of statins on the progression of the radial IMT after the transradial intervention.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing coronary intervention via the radial artery

Exclusion Criteria:

* Contraindication to statins
* Left ventricular ejection fraction less than 30%
* Recent history of hematologic disease or leukocyte count \<3000/mm3 and/or platelet \<100 000/mm3
* Hepatic dysfunction with AST or ALT \>3 times the upper normal reference limit
* History of renal dysfunction or a serum creatinine level \>2.0 mg/dL
* Serious noncardiac comorbid disease with a life expectancy \<1 year
* Inability to follow the protocol

Primary outcomes:
measure: Difference of IMT between two groups
timeFrame: 1 month, 6 months
Secondary outcomes:
measure: Difference of epicardial fat thickness Difference of cholesterol level
timeFrame: 6 months
Other outcomes:
Locations:
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
Study officials:
affiliation: Chungnam National University, Chungnam National University Hospital
name: Jae-Hyeong Park, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05764070: Impact of Vagus Nerve Stimulation on Post-Aerobic Activity Recovery in Post SARS-CoV-2 Patients
Official title: Impact of Vagus Nerve Stimulation on Post-Aerobic Activity Recovery in Post Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-COVID-19 Syndrome
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2023-03-10
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Chronic fatigue, weakness, dyspnea, headaches, cognitive dysfunction, stress, sadness, anxiety, sleep disturbances, and orthostatic intolerance are among the symptoms of acute Covid-19 in patients, and these symptoms persist for more than 12 weeks after recovery. Extended Covid-19 syndrome, also known as Post-Covid-19 syndrome, is described as

Detailed description: Therapeutic exercises are an evidence-based method for the maintenance of musculoskeletal, cardiovascular and neurological well-being and the prevention and treatment of chronic diseases. The effects of therapeutic exercises on the human body varied according to the frequency, intensity, duration and type of exercise.

Increasing physiological and psychological recovery after exercise can lead to results such as better performance and reducing the risk of injury. Therefore, various methods are used to facilitate post-exercise recovery.

The best-known and most widely used post-exercise recovery method is active cooling, also known as active rest or cool-down. Active cooling; It is defined as any activity that includes voluntary, low/moderate intensity exercise or movement performed within one hour of exercise. Passive rest, on the other hand, is defined as no or minimal voluntary/intentional exercise movement.

Eligibility criteria: Inclusion criteria:

* Covid
* be between 18-45 years old
* Having pulmonary involvement in the covid process

Exclusion criteria:

* Being a professional in any sport
* Having a cardiopulmonary, orthopedic, neurological and metabolic disease

Primary outcomes:
measure: Visual Analogue Scale (VAS)
timeFrame: a day
measure: Autonomic nervous system device (Polar H10)
timeFrame: a day
measure: Lactate Analysis
timeFrame: one day
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Bahçeşehir University
state: Istanbul Avrupa Kitasi
Study officials:
References:
citation: McNarry MA, Berg RMG, Shelley J, Hudson J, Saynor ZL, Duckers J, Lewis K, Davies GA, Mackintosh KA. Inspiratory muscle training enhances recovery post-COVID-19: a randomised controlled trial. Eur Respir J. 2022 Oct 6;60(4):2103101. doi: 10.1183/13993003.03101-2021. Print 2022 Oct.
Clinical trial NCT05699070: Drug-drug Interactions Between DWC202211 and DWC202212 in Healthy Subjects
Official title: An Open-label Phase 1 Study to Evaluate Pharmacokinetic/Pharmacodynamic Drug-drug Interactions and Safety/Tolerability of DWC202211 and DWC202212 Compared to Coadministration in Healthy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Drug-drug Interaction
Lead sponsor: Daewoong Pharmaceutical Co. LTD.
Sponsor class: INDUSTRY
First posted: 2023-01-26
Enrollment: 24
Sex: ALL
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: An open-label phase 1 study to evaluate pharmacokinetic/pharmacodynamic drug-drug interactions and safety/tolerability of DWC202211 and DWC202212 compared to coadministration in healthy


Eligibility criteria: Inclusion Criteria:

* Healthy adults aged ≥ 19 and ≤ 50 years at screening
* Subjects with a body weight ≥ 50.0 kg to ≤ 90.0 kg with a body mass index (BMI) of ≥ 18.0 kg/m2 to ≤ 27.0 kg/m2 at screening

  ※ BMI (kg/m2) = body weight (kg)/\[height (m)\]2
* Subjects who voluntarily decided to participate in the study and provided written consent to follow precautions after receiving a sufficient explanation on this study and fully understanding the information
* Subjects who are eligible to participate in the study at the discretion of the investigator by physical examination, laboratory tests, and investigator questioning, etc.

Primary outcomes:
measure: Cmax
timeFrame: up to 27 days
measure: AUClast
timeFrame: up to 27 days
Secondary outcomes:
measure: DWC202211 Tmax,ss
timeFrame: up to 27 days
measure: DWC202211 T1/2,ss
timeFrame: up to 27 days
measure: DWC202211 Cmin,ss
timeFrame: up to 27 days
measure: DWC202211 Cavg,ss
timeFrame: up to 27 days
measure: DWC202211 CLss/F
timeFrame: up to 27 days
measure: DWC202211 Vdss/f
timeFrame: up to 27 days
measure: DWC202211 PTF
timeFrame: up to 27 days
measure: DWC202212 Tmax,ss
timeFrame: up to 27 days
measure: DWC202212 T1/2,ss
timeFrame: up to 27 days
measure: DWC202212 Cmin,ss
timeFrame: up to 27 days
measure: DWC202212 Cavg,ss
timeFrame: up to 27 days
measure: DWC202212 CLss/F
timeFrame: up to 27 days
measure: DWC202212 Vdss/f
timeFrame: up to 27 days
measure: DWC202212 PTF
timeFrame: up to 27 days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT04145570: A Single-Dose,ComparativeBioavailability Study ofTwo Formulations ofErlotinib150mgTabletsunderFastingConditions
Official title: A Single-Dose,ComparativeBioavailability Study ofTwo Formulations ofErlotinib150mgTabletsunderFastingConditions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Lung Cancer
Lead sponsor: Quadras Scientific Solutions
Sponsor class: OTHER
First posted: 2019-10-30
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Based on the log-transformed parameters, the following criteria were used to evaluate the bioequivalence between the test and reference products:

* The 90% confidence interval of the relative mean AUCt of the test to reference products should be between80% and125%.
* TherelativemeanCmaxofthetesttoreferenceproductsshouldbebetween80% and125%
Primary purpose: OTHER

Brief summary: Theobjectiveofthisstudyistoevaluatethecomparativebioavailabilitybetween:

* ErlotinibHCl150mgTablets(Novopharm Limited,Canada)and
* Tarceva® 150mgTablets(Hoffmann-LaRocheLimited,Canada) afterasingle-doseinhealthysubjectsunderfastingconditions.

Detailed description: This is a blinded,single-dose,randomized,two-period,two-sequence,two-treatment,cross over study, designed to evaluate the comparative bioavailability of two formulations of erlotinib HCl 150mg tablets administered to healthy male and female subjects under fasting conditions.

• SubjectswererandomlyassignedtooneofthetwodosingsequencesABorBA underfasting conditions.

Eligibility criteria: Inclusion Criteria:

* Healthy, non-smoking, post-menopausal and/or surgically sterile female subjects
* Healthy,non-smoking male subjects. Allsubjects willbe from 18 to 55 years ofage.

Exclusion Criteria:

* Known history or presence of any clinically significant medicalcondition.
* Known or suspected carcinoma.
* Presence ofclinically significant gastrointestinal disease or history of malabsorption within the last year.
* Presence of a medical condition requiring regular medication (prescription and/or over-the-counter) with systemic absorption.
* Use of tobacco or nicotine-containing products within 6 months priorto drug administration.

Primary outcomes:
measure: Bioequivalence (Biodisponibility)
timeFrame: 72 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02686970: Spanish Adaptation and Study of Reliability of the European Quality Questionnaire (EuroQ2)
Official title: Spanish Adaptation and Study of Reliability of the European Quality Questionnaire (EuroQ2)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Critical Illness
Keywords: Family
Quality
Validate
ICU
Lead sponsor: Corporacion Parc Tauli
Sponsor class: OTHER
First posted: 2016-02-22
Enrollment: 132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Family member or person responsible for patient decision making in the ICU

Brief summary: The aim of this study is to adapt and validate to the Spanish the European Quality Questionnaire (EuroQ2) to evaluate families' experiences of quality of care for critically ill and dying patients in the ICU.

Detailed description: The aim of this study is to adapt and validate a Spanish-language version of the European Quality Questionnaire (EuroQ2). Using a forward-backward translation methodology, we will translate the EuroQ2 into Spanish and will evaluate its psychometric characteristics in a clinical sample of 200 family members responsible for making medical decisions for patients who are discharged from the ICU or who died in the ICU. Cronbach's alpha values, confirmatory factor analysis (CFA) will be evaluated in order to know the reliability, construct validity, and convergent validity.

Eligibility criteria: Inclusion Criteria:

* Family members of patients admitted to the ICU for 48 hours or more.
* Family members responsible for patient decision making in the ICU who consent participate.

Exclusion Criteria:

* Family members younger than 18 years,
* Family members not able to read or write Spanish

Primary outcomes:
measure: European Quality Questionnaire (euroq2)
timeFrame: 48 h after discharge of patients alive from ICU or 1 month after the death into ICU
Secondary outcomes:
Other outcomes:
Locations:
city: Sabadell
country: Spain
facility: Corporacion Parc Taulí
state: Barcelona
Study officials:
affiliation: Corporacion Parc Tauli
name: Francisca Pérez-López, RN, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jensen HI, Gerritsen RT, Koopmans M, Zijlstra JG, Curtis JR, Ording H. Families' experiences of intensive care unit quality of care: Development and validation of a European questionnaire (euroQ2). J Crit Care. 2015 Oct;30(5):884-90. doi: 10.1016/j.jcrc.2015.06.004. Epub 2015 Jun 16.
citation: Gerritsen RT, Hofhuis JGM, Koopmans M, van der Woude M, Bormans L, Hovingh A, Spronk PE. Perception by family members and ICU staff of the quality of dying and death in the ICU: a prospective multicenter study in The Netherlands. Chest. 2013 Feb 1;143(2):357-363. doi: 10.1378/chest.12-0569.
Clinical trial NCT00821470: Treatment of Osteonecrosis of the Femoral Head by Bone Marrow Transplantation
Official title: Treatment of Osteonecrosis of the Femoral Head With Implantation of Autologous Bone Marrow Cells, a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Necrosis
Keywords: osteonecrosis
bone marrow
core decompression
femoral head
Lead sponsor: Erasme University Hospital
Sponsor class: OTHER
Collaborators: name: Fonds National de la Recherche Scientifique
First posted: 2009-01-13
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aseptic non traumatic osteonecrosis (ON) is a painful disorder of the hip which often leads, in its final stage, to femoral head collapse and subsequent total hip replacement. Core decompression of the hip is the most widespread procedure used to treat early stage ON of the femoral head. Notwithstanding the fact that this procedure has been employed for more than three decades (2), its efficacy remains controversial (3;4). Recently, one suggested that ON might be a disease of bone cells and/or of mesenchymal cells. The levels of activity and the number of mesenchymal stem cells in both the hematopoietic and in the stromal compartments of the bone marrow have been shown to be depressed in patients with ON of the femoral head (9). The investigators have showed previously that the capacity of osteoblastic cells to replicate was decreased in the proximal femur of patients with ON of the femoral head (10). This finding raised the possibility that bone marrow containing stromal cells which have many of the characteristics of stem cell for mesenchymal tissues including bone could be implanted into the necrotic lesion of the femoral head.


Eligibility criteria: Inclusion Criteria:

* ARCO stage 1 or 2 osteonecrosis of the femoral head

Exclusion Criteria:

* The investigators excluded patients with evidence of a malignant disorder during the past five years.

Primary outcomes:
measure: WOMAC Score
timeFrame: 60 months
Secondary outcomes:
measure: Disease progression defined as progression to a fractural stage of osteonecrosis
timeFrame: 60 months
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Erasme Hospital
Study officials:
affiliation: Erasme hospital
name: valerie gangji
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01518270: Epidemiologic Analysis of Change in Eyelash Characteristics With Age in Healthy Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Health
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2012-01-25
Enrollment: 179
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy Females

Brief summary: This study will asses epidemiologic changes in eyelash characteristics with increasing age.


Eligibility criteria: Inclusion Criteria:

* Willing to have photographs taken of the face/eye regions

Exclusion Criteria:

* No visible eyelashes
* Permanent eyeliner or eyelash implants
* Semi-permanent eyelash tint, dye, or extensions within the last 3 months
* Use of prescription eyelash growth products in the last 6 months

Primary outcomes:
measure: Eyelash Length as Measured by Digital Image Analysis (DIA)
timeFrame: Baseline
Secondary outcomes:
measure: Eyelash Thickness as Measured by Digital Image Analysis (DIA)
timeFrame: Baseline
measure: Eyelash Darkness as Measured by Digital Image Analysis (DIA)
timeFrame: Baseline
Other outcomes:
Locations:
city: Irvine
country: United States
state: California
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Glaser DA, Jones D, Carruthers J, Campo A, Moench S, Tardie G, Largent J, Caulkins C. Epidemiologic analysis of change in eyelash characteristics with increasing age in a population of healthy women. Dermatol Surg. 2014 Nov;40(11):1208-13. doi: 10.1097/DSS.0000000000000170.