louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01784133: A Twelve Week Safety and Efficacy Study in Rosacea
Official title: A Phase 2, Randomized, Vehicle-Controlled, Double-Blind, Multicenter Study to Evaluate the Safety and Efficacy of Three Once-Daily CLS001 Topical Gels Versus Vehicle Administered for 12 Weeks to Subjects With Papulopustular Rosacea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Papulopustular Rosacea
Keywords: rosacea
Lead sponsor: Maruho Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2013-02-05
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate th safety and efficacy of one-daily topical application of CLS001 low, mid and high dose compared to vehicle gel in subjects with papulopustular rosacea.


Eligibility criteria: Inclusion Criteria:

* diagnosis of papulopustular rosacea (at least 15 lesions)

Exclusion Criteria:

* nodular rosacea or subtype 3
* clinically significant abnormal findings that would interfere with study objectives

Primary outcomes:
measure: Change in inflammatory lesion count
timeFrame: 0, 1, 3, 6, 9 and 12 weeks
Secondary outcomes:
measure: Success on IGA defined as clear or almost clear
timeFrame: Week 12
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Radiant Research Inc.
state: Alabama
city: Santa Monica
country: United States
facility: ATS Clinical Research
state: California
city: New Haven
country: United States
facility: The Savin Center, PC
state: Connecticut
city: Boca Raton
country: United States
facility: Skin Care Research, Inc
state: Florida
city: Dunedin
country: United States
facility: Dunedin Research Specialists
state: Florida
city: Jacksonville
country: United States
facility: North Florida Dermatology Associates
state: Florida
city: Indianapolis
country: United States
facility: Dawes Fretzin Clinical Research Group
state: Indiana
city: Warren
country: United States
facility: Grekin Skin Institute
state: Michigan
city: Rochester
country: United States
facility: Rochester General Medical Group Center for Dermatology at Linden Oaks
state: New York
city: Stoney Brook
country: United States
facility: Derm Research Center of NY Inc.
state: New York
city: Raleigh
country: United States
facility: Wake Resarch
state: North Carolina
city: Portland
country: United States
facility: Oregon Dermatology and Research Center
state: Oregon
city: Johnson City
country: United States
facility: TriCities Skin and Cancer
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Clinical Research Center
state: Tennessee
city: San Antonio
country: United States
facility: Progressive Clinical Research, PA
state: Texas
city: Salt Lake City
country: United States
facility: Dermatology Research Center
state: Utah
city: Norfolk
country: United States
facility: Virginia Clinical Research Inc.
state: Virginia
Study officials:
References:
Clinical trial NCT06767033: Inferior Vena Cava Collapsibility Index Assessment in Predicting Post Spinal Anaesthesia Hypotension in Patients Undergoing Arthroscopic Knee Surgeries.
Official title: Inferior Vena Cava Collapsibility Index Assessment in Predicting Post Spinal Anaesthesia Hypotension in Patients Undergoing Arthroscopic Knee Surgeries.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post Spinal Anaesthesia Hypotension
Inferior Vena Cava Collapsibility Index
Keywords: Inferior Vena Cava Collapsibility Index
Post Spinal Anaesthesia Hypotension
Arthroscopic Knee Surgeries
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2025-01-09
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients American Society of Anesthesiologists Physical Status (ASA) I to II undergoing arthroscopic knee surgeries under spinal anaesthesia.

Brief summary: The aim of this study was to evaluate the role of inferior vena cava collapsibility index assessment in predicting post spinal anaesthesia hypotension in patients undergoing arthroscopic knee surgeries.

Detailed description: Prospective Cohort Study conducted in Ain Shams University Hospitals.

Eligibility criteria: Inclusion Criteria:

* Patients: American Society of Anesthesiologists Physical Status (ASA) I to II undergoing arthroscopic knee surgeries under spinal anaesthesia.
* Both Sexes.
* Aged 30 to 60 years.
* Body mass index \<35 kg/m2

Exclusion Criteria:

* Patients' refusal of procedure or participation in the study.
* Patients with contraindication to spinal anaesthesia.
* Patients with severe cardiovascular or pulmonary disease.
* Patients with pre-procedural hypotension (systolic arterial pressure less than 90 mmHg and/or mean arterial pressure less than 60 mmHg).

Primary outcomes:
measure: to determine the optimal cut-off value of ultrasound guided IVCCI to predict post spinal anaesthesia hypotension.
timeFrame: 6 months
Secondary outcomes:
measure: to measure the total amount of fluids and vasopressor drugs administered to patients to manage post spinal anaesthesia hypotension
timeFrame: 6 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Hospitals
Study officials:
References:
Clinical trial NCT04837833: An Ultrasound Imaging Technique to Measure Tumors in People With Pancreatic Ductal Adenocarcinoma (PDAC) or Gastrointestinal (GI) Adenocarcinoma
Official title: Machine Learning Approach to Sonographic Assessment of Tumor Volumes for Response Assessment in Patients With Pancreas or Gastrointestinal Adenocarcinoma: A Pilot Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pancreas Cancer
Gastrointestinal Adenocarcinoma
Keywords: Sonographic Assessment
Tumor Volumes for Response
21-138
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2021-04-08
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to see if ultrasound images that are analyzed by a special computer program can be used to measure the size of PDAC tumors in the liver as accurately as CT scans that involve contrast material (also called contrast-enhanced CT scans). All participants in this study will have pancreatic ductal adenocarcinoma (PDAC) that has spread (metastasized) to the liver, and all participants will be scheduled for a routine CT scan that will measure their cancer.


Eligibility criteria: Inclusion Criteria:

* Male and female patients, 18 years of age or older
* Confirmed diagnosis of PDAC or GI tract adenocarcinoma metastatic to liver
* Scheduled for imaging with contrast enhanced CT

Exclusion Criteria:

* Inability to tolerate intravenous contrast medium
* All liver metastases ≤ 10 mm in maximal diameter on the contrast enhanced CT used for comparison to the planned research ultrasound
* Multiple confluent liver metastases or tumor burden \> 50% of the liver as estimated by a radiologist

Primary outcomes:
measure: measurement differences between ultrasound tumor volumes
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Kinh Gian Do, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03396133: Efficacy of Snap on Symptomatic Arrhythmia
Official title: Assessment of Portable Remote Health Monitor Using the Snap to Symptomatic Arrhythmia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Arrhythmia
Keywords: Snap
symptomatic arrhythmia
diagnosis
follow-up
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2018-01-10
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Participants in the Snap arm were instructed to undertake once-day recording and transmission of a 30-second single-lead iECG trace to a secure server, plus additional submissions if symptomatic over a 3-month period. Snap traces were analyzed by an automated analysis software and cardiologists. Clinical review and appropriate care was arranged for those clinically significant arrhythmia. Patients in the RC group were followed up as normal methods including ECG, Holter.

Detailed description: Individuals with symptomatic arrhythmia without known arrhythmia were recruited.

Participants were required to have access to the internet via WiFi and to be able to operate the Snap system after simple instruction. Written consent was obtained, and eligible participants were randomized (1:1) to an intervention (Snap) group or RC group.

Eligibility criteria: Inclusion Criteria:

* symptomatic arrhythmia

Exclusion Criteria:

* can not use the Snap instrument and Sign informed consent

Primary outcomes:
measure: Evaluating the ability of handheld device with remote interpretation to screen for arrhythmia
timeFrame: 3-month
Secondary outcomes:
measure: Evaluating the patients' quality of life
timeFrame: 3-month
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Dyno
state: Jiangsu
city: Nanjing
country: China
facility: the First Affiliated Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Chun-Jian Li, PHD
role: STUDY_CHAIR
affiliation: Suqian People's Hospital of Nanjing Drum Tower Hospital Group
name: Jin-Shuang Li, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Liang-Hong Ying, MD
role: STUDY_CHAIR
References:
citation: Halcox JPJ, Wareham K, Cardew A, Gilmore M, Barry JP, Phillips C, Gravenor MB. Assessment of Remote Heart Rhythm Sampling Using the AliveCor Heart Monitor to Screen for Atrial Fibrillation: The REHEARSE-AF Study. Circulation. 2017 Nov 7;136(19):1784-1794. doi: 10.1161/CIRCULATIONAHA.117.030583. Epub 2017 Aug 28.
Clinical trial NCT00659633: The Effect of Intravenous Lidocaine on Allodynia
Official title: The Effect of Intravenous Lidocaine on Allodynia (Carl Koller Grant)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: lidocaine
allodynia
chronic regional pain syndrome
pain
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: American Society of Regional Anesthesia
First posted: 2008-04-16
Enrollment: 10
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to study if lidocaine, given intravenously, reduces pain.

Detailed description: Clinicians use lidocaine intravenously in a fashion that suggests that it might have analgesic effects. Therefore, we test the hypothesis that lidocaine reduces pain intensity in response to experimental pain.

Eligibility criteria: Inclusion Criteria:

* Chronic Regional Pain Syndrome diagnostic criteria by the Work Safe BC. vi

Exclusion Criteria:

* History of Substance abuse
* Other Medications: CRPS patients are expected to be treated for chronic pain, whether the current treatment regimen interferes with sensory motor testing will be determined on a case by case basis.
* Coronary Artery Disease (CAD): unstable
* Congestive Heart Failure (CHF): unstable
* Heart Arrhythmia: symptomatic
* Chronic Obstructive Pulmonary Disease (COPD)
* Lidocaine Allergy
* Diagnostic and Statistical Manual of Mental Disorders (Rev IV): Axis I: Common Axis I disorders include depression, anxiety disorders, bipolar disorder, ADHD, and schizophrenia. Axis II: borderline personality disorder, schizotypal personality disorder, antisocial personality disorder, and mild mental retardation.
* Presence of Contraindications for MRI
* Presence of electronically, magnetically, and mechanically activated implants
* Electronically, magnetically, and mechanically activated implants
* Ferromagnetic or electronically operated active devices like automatic cardioverter defibrillators
* Cardiac pacemakers
* Metallic splinters in the eye
* Ferromagnetic haemostatic clips in the central nervous system (CNS)
* Claustrophobia
* Pregnancy

Primary outcomes:
measure: Pain Perception
timeFrame: Participants will be followed from baseline through 128 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Michael Froelich, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02318433: Intra-Articular Dexamethasone to Prevent Post-Traumatic Osteoarthritis: A Pilot Study
Official title: Intra-Articular Dexamethasone to Prevent Post-Traumatic Osteoarthritis: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Distal Radius Fracture
Osteoarthritis
Keywords: DRF
PTOA
dexamethasone
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2014-12-17
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary aim of the study is to see if a single wrist injection (intra-articular) of dexamethasone at the time of treatment will reduce the incidence of early-onset of post traumatic osteoarthritis.

Detailed description: Our hypothesis is that the intra-articular administration of dexamethasone soon after joint injury will prevent the subsequent development of PTOA, and restore normal joint homeostasis. We plan to generate the data needed to test this hypothesis in a Phase 0 (pilot) clinical trial using patients who have suffered distal radius fractures.

Eligibility criteria: Inclusion Criteria:

1. Unstable distal radius fracture
2. Fracture type AO B1, B2, B3, C1, C2 or C3.
3. 18-65 years old
4. Understand and read English
5. Community dwelling (not in assisted living or NH)

Exclusion criteria:

1. Open or bilateral DRF
2. Associated upper extremity carpal fracture or carpal ligament injuries requiring casting or surgical repair at the time of DRF fixation.
3. Greater than 2 weeks post injury
4. Neurologic disorders affecting the hand, wrist or arm.
5. History of permanent dementia, Alzheimer's or other neurologic dx
6. Substance abuse
7. Pathologic fractures
8. Known pregnancy
9. Radiocarpal joint arthritis

Primary outcomes:
measure: PTOA incidence
timeFrame: 3 years
Secondary outcomes:
measure: Functional assessment
timeFrame: 3 years
measure: Patient-rated evaluations
timeFrame: 3 years
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Sanjeev Kakar, M.D., M.B.A
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00732433: Digital Mammography: Computer-Aided Breast Cancer Diagnosis
Official title: Digital Mammography: Computer-Aided Breast Cancer Diagnosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tumors, Breast
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2008-08-12
Enrollment: 433
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to develop computer programs to assist radiologists in finding breast cancer on mammograms and to compare the computer's accuracy of detecting cancers on direct digital and film mammograms.

Detailed description: To develop a computer-aided diagnosis (CAD) system for full field digital mammography (FFDM) using advanced computer vision techniques and to evaluate the effects of CAD on interpretation of digital mammograms (DMs). This system will assist radiologists with the four most important areas in mammographic interpretation: (1) detection of masses, (2) classification of masses, (3) detection of microcalcifications, (4) classification of microcalcifications. The proposed approach is distinctly different from previous approaches in that image information from two-view and bilateral mammograms will be fused with that from the single-view mammogram to improve lesion detection and characterization.

Eligibility criteria: Inclusion Criteria:

* Females who have been scheduled for mammographic exams.
* Females who have been recommended for work-up or biopsy due to a suspicious finding on their mammogram.
* Females who can give informed consent.

Exclusion Criteria:

* No subject under 18 years of age

Primary outcomes:
measure: Using computer aided programs to assist in detection and characterization of breast lesions in digital mammography.
timeFrame: Research scan will be completed at the time of scheduled clinical visit.
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
Study officials:
affiliation: University of Michigan
name: Heang-Ping Chan, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03535233: Topical 5% Minoxidil and Potent Topical Corticosteroid Versus Intralesional Corticosteroid in the Treatment of Alopecia Areata
Official title: Combined Topical 5% Minoxidil and Potent Topical Corticosteroid Versus Intralesional Corticosteroid in the Treatment of Alopecia Areata A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Alopecia Areata
Keywords: Alopecia areata, intralesional corticosteroid, minoxidil, clobetasol propionate, IL-23, TGFβ-1
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-05-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Alopecia areata (AA) presents with circumscribed patches of non-scarring hair loss. It inflects a significant psychological and social burden. Many treatment options are used for the treatment of AA. Randomized controlled trials comparing intralesional and topical therapy and comparing combinations are few.

The aim of this work is to evaluate the efficacy of combined topical 5% minoxidil and potent topical corticosteroid therapy compared to intralesional triamcinolone injection in alopecia areata


Eligibility criteria: Inclusion Criteria:

* Patients presenting with scalp alopecia areata, patchy type, of at least 2 months duration.

Exclusion Criteria:

* Alopecia totalis and alopecia universalis.
* Alopecia areata solely affecting the beard.
* Pregnant and lactating.
* Patients known to have autoimmune diseases e.g. autoimmune thyroid disease, vitiligo or SLE.
* Patients receiving systemic treatment relevant to alopecia areata within 3 months before enrollment into the study or topical treatment relevant to alopecia areata within 2 months before.
* Patients with a dermatological condition affecting the scalp other than AA: e.g. psoriasis, eczema.
* Patients with psychiatric illness or psychological state interfering with compliance or influencing the expectation of the patient.

Primary outcomes:
measure: Clinical assessment using SALT score (Severity of Alopecia Tool score)
timeFrame: 3 months
Secondary outcomes:
measure: Dermoscopic evaluation
timeFrame: 3 months
measure: Quantitative measurement of Transforming growth factor-beta 1 (TGF-β1)
timeFrame: 3 months
measure: Quantitative measurement of Interleukin-23 (IL-23)
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Nermine H El-Eishi, MD
role: STUDY_CHAIR
affiliation: Cairo University
name: Heba M Mashaly, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo University
name: Solwan I El-Samanoudy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo University
name: Mona MI ElKalioby, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo University
name: Olfat G Shaker, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo University
name: Rania M Abdel-Hay, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03323333: Psychosocial Intervention Pilot for Partners in BRCA Testing
Official title: Psychosocial Intervention Pilot for Partners in BRCA Testing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Georgetown University
Sponsor class: OTHER
First posted: 2017-10-27
Enrollment: 10
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: A brief psychosocial intervention for partners of women affected by or at risk for breast cancer and harboring BRCA genetic alterations.


Eligibility criteria: Inclusion Criteria:

* Age, married/partnered status

Exclusion Criteria:

-

Primary outcomes:
measure: Communication of genetic test results
timeFrame: 1 Month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04999033: The Development of Patient Experience With Nursing Care Scale
Official title: The Development of Patient Experience With Nursing Care Scale in China
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Patient Experience
Nurse-Patient Relations
Keywords: patient experience
nursing care
scale
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2021-08-10
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible inpatients will be invited to participate the study. For anonymity, participants will be are identified with the letter P followed by a number

Brief summary: Nurses are a vital and central part of the health care system, accounting for nearly half of the global health workforce and spending more time with patients than any other medical professionals. Patient experience with nursing care, as a process indicator, reflects the interpersonal aspects of care received and has an important impact on overall experience and satisfaction with hospital care. The results of the previous study showed that the most important predictor of patient satisfaction with hospitals was patient experiences with nursing care.

Since nurses are so deeply and widely involved in patients' care, an instrument with a clear conception definition, systematically developed and psychometrically validated will be extremely valuable in measuring patient experience with nursing care, so as to collect and analyze patient feedback toward nursing services, and push the quality improvement according to the preferences, needs and values of the healthcare recipients.

This study, therefore, aimed to develop construct and validate a comprehensive and internally consistent instrument to measure patient experience with nursing care in the Chinese hospital setting.


Eligibility criteria: Inclusion Criteria:

1. had been hospitalized for 2 days or more;
2. able to speak and understand Chinese.

Exclusion Criteria:

patients with cognitive impairment.

Primary outcomes:
measure: patient experience with nursing care
timeFrame: September. 2021
Secondary outcomes:
measure: patient satisfaction with nursing care
timeFrame: September. 2021
Other outcomes:
Locations:
city: Shanghai
country: China
facility: 180 Fenglin Road
Study officials:
References: