louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02439190: CV004-007 Thrombosis Chamber Study
Official title: A Single Dose Study to Evaluate the Effect of BMS-986120 on Thrombus Formation in an Ex Vivo Thrombosis Chamber Model in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Thrombosis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2015-05-08
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to determine whether BMS-986120, aspirin, or aspirin and clopidogrel decrease blood clotting.


Eligibility criteria: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs and clinical laboratory determinations
* Body Mass Index (BMI) of 18 to 32 kg/m2 inclusive. BMI = weight (kg)/ \[height (m)\]2
* Females who are not of childbearing potential (i.e., who are post-menopausal or surgically sterile) and men ages 18 to 65, inclusive
* Azoospermic males and women who are not of child-bearing potential (i.e. are postmenopausal or surgically sterile; see section 3.3.3 for the definition of WOCBP) are exempt from contraceptive requirements. However, women must still undergo pregnancy testing as described in this section

Exclusion Criteria:

* Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population
* Any condition that could affect drug absorption
* Other protocol-defined exclusion criteria could apply

Primary outcomes:
measure: Change from baseline in thrombus area (post-treatment with BMS-986120 vs. pre-treatment)
timeFrame: 2 days
Secondary outcomes:
measure: Safety and tolerability of BMS 986120 or aspirin administered with and without clopidogrel based on adverse events,clinical laboratory tests, physical examinations and vital signs per the collection schedule
timeFrame: 2 days
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: Local Institution
state: Scotland
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Wilson SJ, Ismat FA, Wang Z, Cerra M, Narayan H, Raftis J, Gray TJ, Connell S, Garonzik S, Ma X, Yang J, Newby DE. PAR4 (Protease-Activated Receptor 4) Antagonism With BMS-986120 Inhibits Human Ex Vivo Thrombus Formation. Arterioscler Thromb Vasc Biol. 2018 Feb;38(2):448-456. doi: 10.1161/ATVBAHA.117.310104. Epub 2017 Dec 21.
Clinical trial NCT01798290: Impact of Narrative Medicine (Workshop Reading Diaries)
Official title: Impact of an Educational Program 'Narrative Medicine (Workshop Reading Diaries) ' Dedicated to Medical Students. A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Empathy
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2013-02-25
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Objective: The aim of this study is to assess the impact of an educational program of Narrative Medicine "workshop reading diaries" dedicated to medical students on their empathy.

Design: Randomized Controlled Trial in 2 arms. Participants: Medical students (4th years) of the University Paris Descartes. Methods: participants will be randomized in 2 groups. The allocation of participants will be done by a computerized randomization list, the sequence will be created by an independent statistician. Participants will be blinded of the study hypothesis. Allocation concealment will be provided because only the statistician will have access to the randomization list.

A program of Narrative Medicine with lesson in small group of "workshop reading patients' diaries " vs "workshop reading literature".

Outcome: The primary endpoint will be a first measure of the empathy of the medical students. The secondary endpoints will be a second measure of the empathy of the medical student; satisfaction of the student relative to the educational program .

Potential interests: We believe that the workshop "reading patients' diaries" can develop the thinking of the student with respect to his behavior with the patient, and so the relation between student and patient.

Sample size expected: 200 participants.


Eligibility criteria: Inclusion Criteria:

* All students in the fourth year of medical

Exclusion Criteria:

* refuse to participate

Primary outcomes:
measure: The Jefferson Scale of Physician Empathy
timeFrame: 5 months after randomization (i.e. 1 month after the end of the intervention)
Secondary outcomes:
measure: The Interpersonal Reactivity Index
timeFrame: 5 months after randomization (i.e. 1 month after the end of the intervention)
measure: students' satisfaction
timeFrame: 4 months after randomization (i.e. 1 month after the end of the intervention)
Other outcomes:
Locations:
city: Paris
country: France
facility: Centre d'épidémiologie clinique, Hôtel Dieu
Study officials:
References:
Clinical trial NCT01720290: Comparison of Repaglinide and Metformin Administered Alone or in Combination in Type 2 Diabetes
Official title: A 3-month, Open-label, Randomized, Multi-center Study of Repaglinide in Combination With Metformin as Compared to Metformin or Repaglinide Given as Monotherapy for the Treatment of Type 2 Diabetes.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-11-02
Enrollment: 150
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Asia. The aim of this trial is to compare repaglinide and metformin administered alone or in combination in subjects with type 2 diabetes.


Eligibility criteria: Inclusion Criteria:

* Previously treated with oral hypoglycaemic agents (OHA) as monotherapy (if metformin, less than 1500 mg daily)
* Body Mass Index (BMI) of 21-35 kg/m\^2
* HbA1c (glycosylated haemoglobin A1c) between 7.0-10%

Exclusion Criteria:

* Treatment with insulin within the last 3 months preceding the trial
* Uncontrolled treated or untreated hypertension (systolic blood pressure above or equal to 180 mm Hg, and/or diastolic blood pressure above 105 mm Hg)
* Participation in any other clinical trial within 30 days of screening

Primary outcomes:
measure: Change in HbA1c (glycosylated haemoglobin A1c)
Secondary outcomes:
measure: Fasting blood glucose (FBG)
measure: 1-hour post prandial blood glucose (PPBG)
measure: Incidence of hypoglycemic episodes
Other outcomes:
Locations:
city: Beijing
country: China
facility: Novo Nordisk Investigational Site
state: Beijing
city: Beijing
country: China
facility: Novo Nordisk Investigational Site
city: Shanghai
country: China
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT00244790: The Effects of Obesity and Protein Intake on the Kidney
Official title: The Effects of Obesity and Protein Intake on the Kidney
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Kidney Diseases
Keywords: glomerular hyperfiltration
proteinuria
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2005-10-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine if being overweight and eating lots of protein causes separate changes in the kidney that lead to kidney disease over time. These questions are important because the number of people who have kidney disease is quickly growing. If being overweight and eating lots of protein is found to cause kidney disease, then doctors may be able to limit the number of people with kidney disease by recommending weight loss and eating less protein

Detailed description: The purpose of this study is to test the hypothesis that being obese leads to changes in kidney function that are independent of, and enhanced by, high dietary protein intake. Kidney function will be measured by the kidney's ability to filter blood and by the amount of protein in the urine. The hypothesis will be tested in the following manner: The first part of the study will involve a crossover design comparing kidney function in obese people with stable weights on a low and high protein diet ("Low/High Protein Study"). The second part of the study will compare kidney function in obese people before and after weight reduction surgery ("Before/After Surgery Study"). Since certain changes in kidney function may lead to kidney disease over time, it is important to confirm the effects of obesity and dietary protein intake on the kidney, especially with the current rise in obese people and the popularity of high protein diets.

Eligibility criteria: Inclusion Criteria:

* Greater than 18 years of age
* Ability to give informed consent
* Not pregnant and using appropriate contraceptive methods, or not of childbearing potential
* BMI of 30 or higher

Exclusion Criteria:

* Iodine or shellfish allergy
* History of adverse reaction to intravenous contrast
* Dialysis dependence
* Diagnosis of diabetes mellitus or taking medicine for diabetes mellitus

Primary outcomes:
measure: glomerular filtration rate
timeFrame: days
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: University Hospital
state: Indiana
Study officials:
affiliation: Indiana University
name: Allon Friedman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00550290: Prophylactic Antibiotics for Prevention of Wound Complications Following Vulvectomy
Official title: Prophylactic Antibiotics for Prevention of Wound Complications Following Vulvectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Wound Infection
Keywords: vulvectomy
wound infection
wound complication
prophylactic antibiotic
Post-operative wound complications following vulvectomy
Lead sponsor: Aultman Health Foundation
Sponsor class: OTHER
First posted: 2007-10-29
Enrollment: 18
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This randomized prospective study will specifically investigate the efficacy of a 24 hour post-operative course of broad-spectrum prophylactic antibiotics - namely Cefazolin - in preventing wound infection and wound breakdown following vulvectomy.

Detailed description: Infectious morbidity in gynecologic oncology has not been thoroughly investigated to date. Included in the literature are several studies that highlight substantial numbers of post-surgical infectious complications. Specifically among patients undergoing radical vulvectomy, the incidence of post-operative wound complication is as high as 58%. Surgery is the treatment of choice for vulvar cancer, but few studies establish protocols or management strategies to prevent the complications of post-operative wound infection and breakdown. This proposed randomized prospective study would specifically investigate the efficacy of a 24 hour post-operative course of broad-spectrum prophylactic antibiotics - namely Cefazolin - in preventing wound infection and wound breakdown following vulvectomy. This same regimen has been described by a leader in the field of gynecology in his text - TeLinde's Operative Gynecology. This study will utilize two arms - one as the treatment arm utilizing 24 hours of prophylactic antibiotics and the other as control.

Eligibility criteria: Inclusion Criteria:

* All female patients 18 years of age or older undergoing surgery for vulvar carcinoma (this includes female patients undergoing any form of vulvectomy - radical, vulvectomy without groin node dissection, and partial vulvectomy)
* Disease State will not affect inclusion in the study. Women with previous surgery for vulvar carcinoma will be included as will those undergoing initial operation.
* Number of subjects: 160

Exclusion Criteria:

* Women simultaneously undergoing treatment for other forms of cancer
* Women under the age of 18
* Pregnant patients

Primary outcomes:
measure: Wound Complications
timeFrame: Two-week post-operative
Secondary outcomes:
Other outcomes:
Locations:
city: Canton
country: United States
facility: Aultman Health Foundation
state: Ohio
Study officials:
affiliation: Aultman Health Foundation
name: Michael P Hopkins, MD
role: STUDY_CHAIR
affiliation: Aultman Health Foundation
name: William T. Schnettler, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03380390: Safety and Tolerability of Oxymetazoline and Energy-Based Therapy in Participants With Rosacea
Official title: Multicenter, Open-Label, Interventional Study on the Safety and Tolerability of Oxymetazoline and Energy-Based Therapy in Subjects With Rosacea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rosacea
Lead sponsor: Aclaris Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2017-12-21
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the safety and tolerability of oxymetazoline HCl cream 1.0% when used as an adjunctive treatment to energy-based therapy for participants with moderate to severe persistent facial erythema associated with rosacea.


Eligibility criteria: Inclusion Criteria:

-Documented clinical diagnosis of rosacea.

Exclusion Criteria:

* History of any of the following conditions: Raynaud's syndrome, narrow angle glaucoma, orthostatic hypotension, cerebral or coronary insufficiency, thromboangiitis obliterans, scleroderma, Sjögren's syndrome, severe or unstable or uncontrolled cardiovascular disease, or any other current uncontrolled systemic disease
* Diagnosis or presence of any of the following conditions: rosaceaconglobata, rosacea fulminans, isolated rhinophyma, isolated pustulosis of the chin, peri-oral dermatitis, demodicidosis, facial keratosis pilaris, seborrheic dermatitis, acute lupus erythematosus, or chronic recurring facial acne
* Current treatment with monoamine oxidase (MAO) inhibitors
* Current treatment with niacin ≥ 500 mg/day
* Greater than 3 inflammatory lesions on the face
* History or current evidence of drug or alcohol abuse within 12 months prior to the screening visit.

Primary outcomes:
measure: Percentage of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
timeFrame: Baseline (Day 1) to Day 56
measure: Percentage of Participants With at Least a 1-Grade Improvement From Baseline in the Clinical Erythema Assessment Scale at Any Time-point
timeFrame: Baseline (Day 1) to Day 56
measure: Percentage of Participants With at Least a 1-Grade Worsening From Baseline in the Clinician's Telangiectasia Assessment (CTA) at Any Time-point
timeFrame: Baseline (Day 1) to Day 56
Secondary outcomes:
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Center for Dermatology and Laser Surgery
state: California
city: Chestnut Hill
country: United States
facility: SkinCare Physicians
state: Massachusetts
city: Hackensack
country: United States
facility: Skin Laser and Surgery Specialists of NY/NJ
state: New Jersey
city: New York
country: United States
facility: Laser & Skin Surgery Center of New York Professional Corporation
state: New York
Study officials:
affiliation: Allergan
name: Nancy Alvandi
role: STUDY_DIRECTOR
References:
Clinical trial NCT04482790: Restoring Black Triangle With Bioclear Matrix Versus Celluloid Conventional Matrix Method
Official title: Restoring Black Triangle With Bioclear Matrix and Injection Molding Technique Versus Celluloid Conventional Matrix Method: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gingival Black Triangle
Keywords: black triangle
bio-clear cervical matrix
dental esthetics
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-07-23
Enrollment: 26
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Assessment of bioclear matrix and injection molding technique against conventional celluloid matrix technique in management of black triangle.

Detailed description: Patients with black triangle defect in anterior teeth (Cl I and Cl II according to Nordland and Tarnow classification) managed by Bioclear matrix with injection molding technique and conventional celluloid matrix technique.

Eligibility criteria: Inclusion Criteria:

* Patients eligible for the trial must comply with all of the following:

  * Cl I and cl II according to Nordland and Tarnow classification
  * Good oral hygiene
  * Good general health
  * Cooperative patient
  * Subjects who signed the informed consent
  * Patient compliance

Exclusion Criteria:

* Cl III according to Nordland and Tarnow classification
* Uncontrolled parafunction.
* Insufficient oral hygiene
* Periodontal and gingival diseases
* Pregnant and nursing
* Disabilities
* Systemic disease or severe medical complications
* Lack of compliance

Primary outcomes:
measure: Esthetic evaluation
timeFrame: 12 months
Secondary outcomes:
measure: Marginal adaptation
timeFrame: 12 months
Other outcomes:
measure: Phonetics
timeFrame: 12 months
measure: Food impaction
timeFrame: 12 months
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry, Cairo University
Study officials:
affiliation: Cairo University
name: Aya O Hussien, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06153290: Patient Perceptions Following a Single Session of Simulated or Genuine HVLA Manual Chiropractic Adjustments
Official title: Blinding Integrity Following a Single Session of Simulated or Genuine High Velocity, Low Amplitude (HVLA) Manual Chiropractic Adjustments: a Randomized Controlled Proof-of-concept Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Subluxation
Keywords: randomized
sham-controlled
chiropractic
blinding
Lead sponsor: Life University
Sponsor class: OTHER
First posted: 2023-12-01
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, sham-controlled, proof-of-concept trial
Primary purpose: OTHER

Brief summary: The primary aim of this trial is to assess blinding following simulated/sham or genuine/real high velocity, low amplitude (HVLA) manual chiropractic adjustments.

Detailed description: The primary aim of this trial is to assess blinding following simulated/sham or genuine/real high velocity, low amplitude (HVLA) manual chiropractic adjustments. Briefly, 30 eligible participants will be randomized (1:1 ratio) to receive a single session of either simulated/sham or genuine/real chiropractic spinal adjustments and be given a brief survey immediately following their session and 48 hours later that captures their perceptions and experiences regarding the intervention they received. This study is intended to inform a future multi-session, randomized, sham-controlled trial.

Eligibility criteria: Inclusion Criteria:

* 18-60 years of age

Exclusion Criteria:

* History of stroke or transient ischemic attack or current symptoms including dizziness or vertigo, tinnitus (ringing in the ears), or visual, sensory, or motor disturbances
* New pattern headache complaint
* Recent whiplash injury (within 12 months)
* Cervical fracture/dislocation
* Disc problem with radiating symptoms to the arms or legs
* Severe degenerative joint disease in the spine
* Connective tissue disorder
* Primary fibromyalgia
* Metabolic or metaplastic bone disease
* History of cervical, thoracic, or lumbar spine surgery
* Uncontrolled high blood pressure or vascular disease
* Current use of anticoagulant therapy
* Doctor of Chiropractic (DC) or a DC student in 5th quarter or above
* Present, self-reported pregnancy

Primary outcomes:
measure: Participant blinding
timeFrame: Immediately after intervention
measure: Participant blinding
timeFrame: 48 hours after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Marietta
country: United States
facility: Dr. Sid E. Williams Center for Chiropractic Research
state: Georgia
Study officials:
affiliation: Life University
name: Tyson Perez, DC, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04393090: eHealth for the Elderly
Official title: Multiple Myeloma Patients and Their HCPs Tested eHealth Support
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Myeloma
Lead sponsor: Cankado GmbH
Sponsor class: INDUSTRY
First posted: 2020-05-19
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 30 patients (median age 75 years) suffering from multiple myeloma treated by oral IMiDs in 8 medical centers were asked to use the open eHealth platform CANKADO as a digital therapy-supporting tool.

Brief summary: Since internet usage as a complementing element in cancer care is becoming more and more important in oncological routine we launched My-eStEPs (eHealth Strategy for Elderly Patients with Multiple Myeloma) to investigate how specifically elderly patients and their Healthcare Professionals (HCPs) adopt electronic Health (eHealth) support during outpatient treatment. The purpose of this project is to explore how eHealth support influences patients' interaction with their HCPs and how both can benefit from this.


Eligibility criteria: Inclusion Criteria:

* multiple myeloma patients
* treated by oral IMiDs

Exclusion Criteria:

-

Primary outcomes:
measure: Frequency of patient's internet use
timeFrame: 3 months
measure: Purpose of patient's internet use
timeFrame: 3 months
measure: Patient's internet use for health-related topics
timeFrame: 3 months
measure: Patient's technical equipment
timeFrame: 3 months
measure: eHealth usage satisfaction
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Aschaffenburg
country: Germany
facility: Hämato-Onkologische Schwerpunktpraxis
city: Eschweiler
country: Germany
facility: St.-Antonius-Hospital
city: Hamburg
country: Germany
facility: Praxis am Albertinen- Krankenhaus
city: Koblenz
country: Germany
facility: Institut für Versorgungsforschung in der Onkologie GbR
city: Köln
country: Germany
facility: Onkologie-Köln,
city: Langen
country: Germany
facility: Gemeinschaftspraxis für Hämatologie und Onkologie
city: Neuwied
country: Germany
facility: Praxis Dr. med. Peter Ehscheidt, Facharzt für Innere Medizin, Hämatologie, Onkologie, Medikamentöse Tumortherapie und Palliativmedizin
city: Wiesbaden
country: Germany
facility: Medicum
Study officials:
affiliation: Cankado GmbH
name: Timo Schinköthe, PhD
role: STUDY_DIRECTOR
References: