louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03503240: QI: Patient Satisfaction With Facial Appearance, Scar Outcome and Quality of Life After Skin Cancer Surgery
Official title: QI: Patient Satisfaction With Facial Appearance, Scar Outcome and Quality of Life After Skin Cancer Surgery
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Skin Cancer
Keywords: Quality of Life
survey
18-168
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2018-04-19
Enrollment: 3000
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: At MSK potential participants will be identified as having undergone surgery/ treatment for the treatment of a cutaneous malignancy on the face or patients w ill be recruited in the clinic when they present for consultation or the day of skin surgery/ treatment.

Brief summary: The purpose of this study is to evaluate patient satisfaction and quality of life as it relates to skin cancer surgery. This research study involves taking a one-time survey online.


Eligibility criteria: Inclusion Criteria:

* Patients ≥ 18 years of age at the time of surgery.
* Had a diagnosis of a cutaneous malignancy on the face

  * Cutaneous malignancy includes, but is not limited to basal cell carcinoma, squamous cell carcinoma, and melanoma
  * The face is defined as location in the following areas: forehead, temple, eyebrow, eyelids, cheek, nose, lips, chin, and ears.
* Able to speak and read English
* MSK Only Cross Sectional Study: Radiation therapy patients ≥ 18 years of age who have received RT for skin cancer

Exclusion Criteria:

* Unable to speak and read English

Primary outcomes:
measure: number of patients satisfied with facial appearance
timeFrame: 1 year
measure: number of patients satisfied with scar outcome
timeFrame: 1year
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis Comprehensive Cancer Center
state: California
city: Boston
country: United States
facility: Brigham and Women's Hospital (Data Collection Only)
state: Massachusetts
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center at Dallas
state: Texas
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Erica Lee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02371044: Point-of-Care Testing of Coagulation in Patients Treated With Direct Oral Anticoagulants 1
Official title: Point-of-Care Testing of Coagulation in Patients Treated With Direct Oral Anticoagulants 1
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anticoagulation With Direct Oral Anticoagulants
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
Collaborators: name: Heart and Diabetes Center North Rhine-Westphalia
First posted: 2015-02-25
Enrollment: 60
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: Consecutive stroke patients, who were newly started on oral anticoagulation with rivaroxaban, apixaban or dabigatran for secondary prevention of thromboembolic events.

Brief summary: The investigators study aims to test the correlation between the CoaguChek point-of-care testing (POCT) device (Roche, Switzerland) and low plasma levels of all three currently approved direct oral anticoagulants (DOAC; rivaroxaban, apixaban and dabigatran) and to determine the diagnostic accuracy of POCT to rule out or detect relevant levels of DOAC in real-life stroke patients.


Eligibility criteria: Inclusion Criteria:

* Stroke patients, who were newly started on oral anticoagulation with rivaroxaban, apixaban or dabigatran for secondary prevention of thromboembolic events
* Age ≥ 18 years

Exclusion Criteria:

* Vitamin K antagonists or direct oral anticoagulants ≤ 14 days prior to study participation
* Low-molecular weight heparin ≤ 24 hours
* Unfractionated heparin ≤ 12 hours
* Abnormal coagulation values at baseline (Quick \< 70% or activated thromboplastin time (aPTT) \> 40sec.)
* History of coagulopathy

Primary outcomes:
measure: Effect/Correlation of direct oral anticoagulants (DOAC) on CoaguChek point-of-care testing (POCT) result
timeFrame: 24 hours
Secondary outcomes:
measure: Diagnostic accuracy of the CoaguChek POCT to rule out or detect relevant DOAC levels
timeFrame: 24h
measure: Effect/Correlation of DOAC on prothrombin time (PT), activated thromboplastin time (aPTT), anti-Xa activity and Hemoclot assay
timeFrame: 24h
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital Tuebingen
name: Sven Poli, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ebner M, Birschmann I, Peter A, Hartig F, Spencer C, Kuhn J, Blumenstock G, Zuern CS, Ziemann U, Poli S. Emergency Coagulation Assessment During Treatment With Direct Oral Anticoagulants: Limitations and Solutions. Stroke. 2017 Sep;48(9):2457-2463. doi: 10.1161/STROKEAHA.117.017981. Epub 2017 Aug 3.
citation: Ebner M, Peter A, Spencer C, Hartig F, Birschmann I, Kuhn J, Wolf M, Winter N, Russo F, Zuern CS, Blumenstock G, Ziemann U, Poli S. Point-of-Care Testing of Coagulation in Patients Treated With Non-Vitamin K Antagonist Oral Anticoagulants. Stroke. 2015 Oct;46(10):2741-7. doi: 10.1161/STROKEAHA.115.010148. Epub 2015 Aug 13.
Clinical trial NCT00233844: Studying the Analgesic Mechanism of the "Cough-Trick"
Official title: Studying the Analgesic Mechanism of the "Cough-Trick" - Randomized Crossover Volunteer Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pain
Acute Pain
Venipuncture
Keywords: Acute pain
pain on venipuncture
"cough-trick"
distraction
Lead sponsor: University Medicine Greifswald
Sponsor class: OTHER
First posted: 2005-10-06
Enrollment: 21
Sex: MALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of the trial is to study the possible mechanism of the pain reducing effect of CT at peripheral venipuncture


Eligibility criteria: Inclusion Criteria:

1. Male volunteers aged 20-40 years, height 165-190 cm.
2. Physical status I according to American Society of Anesthesiologists (ASA) classification.
3. Straight run of the vein on the dorsum of the non-dominant hand at least 4 cm long and 3 mm thick
4. No analgesics, anticoagulants and/or antiplatelet agents, sedatives or alcohol

Exclusion Criteria:

1. History of peripheral neuropathy
2. Abnormal skin conditions (infection, scars, psoriasis, eczema)
3. Unsuccessful venipuncture
4. Inflamed site of VP within 1 week after VP

Primary outcomes:
measure: Pain intensity measured on VAS-100 scale
Secondary outcomes:
measure: Heart rate, arterial pressure, hand withdrawal, sweating
Other outcomes:
Locations:
Study officials:
affiliation: Anesthesiology and Intensive Care Medicine Department, Ernst Moritz Arndt University of Greifswald, Germany
name: Taras I. Usichenko, Assistant Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02549144: Effects of a Large Increase in Dietary Fats and Cholesterol on HDL Composition and Function in Healthy Subjects
Official title: Effects of a Large Increase in Dietary Fats and Cholesterol on HDL Composition and Function in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lipids
Keywords: HDL biochemical composition and function
Lead sponsor: Azienda Ospedaliero, Universitaria Pisana
Sponsor class: OTHER
First posted: 2015-09-15
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: In this study the investigators aimed at measuring the effect of a two-week high-fat/high-cholesterol (HFHC) normocaloric diet on HDL particles biochemical composition and HDL function compared to a two-week low-fat/low-cholesterol (LFLC) normocaloric diet.

Detailed description: HDL particles can change their composition and function in response to a variety of pathological conditions and environmental stimuli. It has been previously shown that a western diet is able to drastically modify biochemical composition, anti-inflammatory and anti-oxidant properties of HDL in animals. In humans little is known on the role of diet on HDL function and composition.

Eligibility criteria: Inclusion Criteria:

* Subjects ≥ 18 and ≤40 years of age
* Lean or overweight (BMI: 18 to 29,9 kg/m2)
* Normal liver and kidney function
* Normal thyroid function
* Stable weight in the last 3 months
* Read and understood the informed consent form and signed it voluntarily

Exclusion Criteria:

* Liver, heart, kidney, lung, infectious, neurological, psychiatric, endocrine, immunological or neoplastic diseases
* Chronic use of drugs or vitamin supplements
* Smoking
* Pregnancy or lactation

Primary outcomes:
measure: Dichlorofluorescein fluorescence slope
timeFrame: 14 days
Secondary outcomes:
measure: hydroxyeicosatetraenoic acid
timeFrame: 14 days
measure: hydroxyoctadecadienoic acid
timeFrame: 14 days
Other outcomes:
Locations:
city: Pisa
country: Italy
facility: Azienda Ospedaliero-Universitaria Pisana
state: PI
Study officials:
affiliation: Azienda Ospedaliero, Universitaria Pisana
name: Andrea Natali, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Morgantini C, Trifiro S, Trico D, Meriwether D, Baldi S, Mengozzi A, Reddy ST, Natali A. A short-term increase in dietary cholesterol and fat intake affects high-density lipoprotein composition in healthy subjects. Nutr Metab Cardiovasc Dis. 2018 Jun;28(6):575-581. doi: 10.1016/j.numecd.2018.03.005. Epub 2018 Mar 19.
citation: Trico D, Trifiro S, Mengozzi A, Morgantini C, Baldi S, Mari A, Natali A. Reducing Cholesterol and Fat Intake Improves Glucose Tolerance by Enhancing beta Cell Function in Nondiabetic Subjects. J Clin Endocrinol Metab. 2018 Feb 1;103(2):622-631. doi: 10.1210/jc.2017-02089.
Clinical trial NCT03898544: Gait Kinematics After Primary Total Knee Arthroplasty (TKA) Versus Revision TKA
Official title: Assessment at Short Term of the Gait Kinematics After Primary TKA (Stryker) Versus After Revision TKA. Prospective and Controlled Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Knee Arthroplasty, Total
Gait Analysis
Keywords: gait kinematics
TKA
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
Collaborators: name: Stryker Nordic
First posted: 2019-04-02
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Primary TKA group: symptomatic femorotibial osteoarthritis, with an indication of primary TKA (as Triathlon Stryker)

Revision group: first TKA removal in 1 step for mechanical failure, by a revision TKA (as Triathlon Stryker)

Brief summary: The functional outcomes after TKA are satisfying with a full recovery at 6 months - 1 year. Nevertheless, the revisions of TKA have often lower functional results than primary TKA with a long delay of recovery. The Stryker TKA present the same device for primary TKA and for revision.

The aim of this study is to compare the gait kinematics at 6 months after primary Stryker TKA or Revision Stryker TKA to assess if the objective outcomes are similar with this device.


Eligibility criteria: Inclusion Criteria:

* Primary TKA group: symptomatic femorotibial osteoarthritis, with an indication of primary TKA (as Triathlon Stryker)
* Revision group: first TKA removal in 1 step for mechanical failure, by a revision TKA (as Triathlon Stryker)

Exclusion Criteria:

* Septic failure
* Second or more failure in the revision group
* Associated surgical procedure as osteotomy, allograft...
* Not full weight bearing postoperatively
* Refusal to participate

Primary outcomes:
measure: Femorotibial mechanical axis (varus, valgus) analysis
timeFrame: at 6 months postoperatively
measure: range of motion (flexion, extension) analysis
timeFrame: at 6 months postoperatively
measure: internal/external rotation analysis
timeFrame: at 6 months postoperatively
measure: Walking speed
timeFrame: at 6 months postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hôpital de la Croix Rousse
Study officials:
affiliation: Hospices Civils de Lyon
name: Sébastien Lustig, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05981144: Exploration of Clonal Hematopoiesis of Indeterminate Potential in Non-ischemic Heart Failure With Reduced Ejection Fraction
Official title: Exploration of Clonal Hematopoiesis of Indeterminate Potential in Non-ischemic Heart Failure With Reduced Ejection Fraction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure With Reduced Ejection Fraction
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2023-08-08
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who need ACEI for cardiovascular disease

Brief summary: Clonal hematopoiesis of indeterminate potential (CHIP) refers to a phenomenon in which blood cells with somatic mutation circulate in the peripheral blood due to abnormal proliferation and differentiation of mutant hematopoietic cells.

CHIP is considered one of the aging phenomena, and the mutant blood cells increased by CHIP cause chronic inflammation, thereby increasing the occurrence of atherosclerotic cardiovascular disease. Therefore, CHIP is known to be closely related to poor prognosis of ischemic heart failure. Meanwhile, chronic inflammation may be involved in the development of non-ischemic myocardial disease, which is one of the major causes of heart failure.

This study will identify CHIP and perform NLRP3 inflammasome assay in 100 non-ischemic heart failure patients and evaluate the relationship between CHIP and inflammation, imaging markers of heart failure, Left ventricle reverse remodeling after guideline-directed medical treatment, and prognosis of heart failure with reduced ejection fraction.


Eligibility criteria: Inclusion Criteria:

1. As an adult over the age of 19
2. A history of left ventricular ejection fraction less than 40% on imaging tests within 3 years (HFrEF diagnosis),
3. Have a cardiac MRI taken within 3 months of being diagnosed with HFrEF,
4. A person who was diagnosed with non-ischemic heart failure by performing coronary artery imaging (angiography, CT) at the time of diagnosis of HFrEF

Exclusion Criteria:

1. Patients with confirmed ischemic cardiomyopathy (when stenosis of 75% or more of major coronary arteries is confirmed on coronary artery imaging or ischemic cardiomyopathy findings such as transmural late gadolinium enhancement on cardiac MRI)
2. History of solid cancer diagnosis and chemotherapy (drugs, radiation)
3. History of blood cancer

Primary outcomes:
measure: Left ventricular reverse remodeling
timeFrame: 3 months after guideline-directed medical treatment
Secondary outcomes:
measure: Clinical outcome
timeFrame: 3 years after enrollment
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance hospital
Study officials:
affiliation: Division of Cardiology, Severance Hospital, Yonsei University College of Medicine
name: Chan Joo Lee
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05205044: Evaluation of Apelin-13 and Apelin-36 in Women With Recurrent Pregnancy Loss
Official title: Evaluation of Apelin-13 and Apelin-36 Concentrations in Women With Primary Unexplained Recurrent Pregnancy Loss
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Recurrent Pregnancy Loss
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2022-01-24
Enrollment: 88
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant females in first trimester

Brief summary: Lower Apelin levels are associated with hypertensive disorders with pregnancy, yet no studies investigated its levels in recurrent pregnancy loss


Eligibility criteria: Inclusion Criteria:

* pregnant women in first trimester
* negative antiphospholipid markers
* normal karyotype

Exclusion Criteria:

* multiple pregnancy
* fetal malformations
* maternal diseases
* smoking or alcohol use
* history of or risk factors for preterm labor

Primary outcomes:
measure: Apelin-13 and Apelin-36
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Maternity Hospital
state: Cairo/القاهرة
city: Cairo
country: Egypt
facility: AinShams Maternity Hospital
Study officials:
References:
Clinical trial NCT02891044: Sun Protection Factor Assay (SPF Assay 105/2016)
Official title: Sun Protection Factor (SPF) Assay: UVA Protection Factor Assay Minimal Persistent Pigment-Darkening Dose
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sunscreening Agents
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2016-09-07
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: To evaluate the Sun Protection Factor efficacy on human skin.


Eligibility criteria: Inclusion Criteria:

* Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing.
* Male and female.
* Aged between 18-70 years old.
* Good health as determined from the HRL SHF (Subject History Form).
* Signed and dated Informed Consent Form.
* Signed and dated HIPAA (Health Insurance Portability and Accountability Act) form.
* An unambiguous MED (Minimal Erythema Dose) or MPPD (Minimal Persistent Pigment Darkening Dose)

Exclusion Criteria:

* Subjects on test at any other research laboratory or clinic.
* Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light.
* Pre-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.)which would interfere with this study.
* Pre-existing other medical conditions (e.g. adult asthma, diabetes).
* Treatment with antihistamines or corticosteroids within one week prior to initiation of the test.
* Treatment with antibiotics within two weeks prior to initiation of the test.
* Chronic medication which could affect the results of the study.
* Known pregnant or nursing women.

Primary outcomes:
measure: Minimal Erythema Dose (MED)
timeFrame: Up to 15 minutes
measure: Minimal Persistent Pigment Darkening Dose (MPPD)
timeFrame: Up to 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Union
country: United States
state: New Jersey
Study officials:
References:
Clinical trial NCT03951844: Wearability, Saefty and Usability Assessment for the Upper Limb Exoskeleton BRIDGE/EMPATIA
Official title: Wearability, Saefty and Usability Assessment for the Upper Limb Exoskeleton BRIDGE/EMPATIA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Muscular Dystrophies
Keywords: Exoskeleton
Upper limb
Assistive device
Lead sponsor: Politecnico di Milano
Sponsor class: OTHER
First posted: 2019-05-15
Enrollment: 14
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The study is a feasibility study or pilot study, that is a clinical investigation to acquire the preliminary information on a motorized exoskeleton (BRIDGE / EMPATIA exoskeleton) for the movement of the upper limb in order to develop it, including design changes. The primary objective of the clinical trial is to assess the fit, safety and usability of the device in supporting the execution of daily activities for patients suffering from muscular dystrophy. The risk analysis for the BRIDGE / EMPATIA device does not present particular criticalities that preclude the use of the device in the target population. In any case, during the trial eventual adverse events are recorded for the verification of safety..


Eligibility criteria: Inclusion criteria:

1. Availability of the patient and/or caregiver at the signing of the informed consent for participation in a clinical trial study protocol
2. Defined diagnosis of Muscular Dystrophy (Duchenne, Becker, Cingoli type 2 and facio-scapulo-humeral). Biopsy will not be performed except in cases where a diagnostic need arises.
3. Wheelchair bounded
4. Significant weakness in the muscular districts of the shoulder girdle and the proximal upper limb portion detected by the MRC scale (between 0 and 2)
5. Cognitive skills that allow the understanding and management of the device
6. Arm length measured from the shoulder to the elbow between 26.5 cm and 28.7 cm; forearm length, measured between elbow and wrist, maximum 22.4 cm

Exclusion criteria:

1. Presence of important comorbidities (epilepsy, dependence 24/24 hours from non-invasive and invasive ventilation)
2. Behavioral and psychiatric disorders (e.g., emotional problems, depression)
3. Inability to maintain a sitting position in a wheelchair

Primary outcomes:
measure: Performance of Upper Limbs scale (PUL)
timeFrame: Change from baseline PUL without the exoskeleton and PUL wearing the exoskeleton within 15 days.
Secondary outcomes:
measure: ABILHAND
timeFrame: Change from baseline PUL without the exoskeleton and PUL wearing the exoskeleton within 15 days.
measure: Technology acceptance model (TAM) questionnaire
timeFrame: Within 15 days from the baseline
measure: System usability scale (SUS)
timeFrame: Within 15 days from the baseline
Other outcomes:
Locations:
city: Bosisio Parini
country: Italy
facility: IRCCS E. Medea - La Nostra Famiglia
state: LC
city: Costa Masnaga
country: Italy
facility: Villa Beretta
state: LC
Study officials:
References: