louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05964270: Telemonitoring Among Patients With Multiple Myeloma
Official title: The Impact of Telemonitoring on Correct Drug Use, Complications and Quality of Life Among Patients With Multiple Myeloma (MM)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Myeloma
Keywords: Value-base health care
e-coach
adherence
Lead sponsor: Isala
Sponsor class: OTHER
First posted: 2023-07-27
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A two-arm open-label parallel-group randomized controlled trial (RCT) will be conducted at a supra regional cancer center (referred to as 'het oncologisch centrum Isala'), which provides hematology services to a population with 0.5 million adherence and a population of 1 million referral, in the Northern-East region of The Netherlands.
Primary purpose: OTHER

Brief summary: A two-arm open-label parallel-group randomized controlled trial will be conducted to compare the telemonitoring (MM e-coach) with standard MM care. This study aimed to recruit 150 patients with recently diagnosed multiple myeloma (RDMM), starting first or second line of treatment. Blinded primary outcome is adherence by pill count after start of treatment at 1-3 months. Secondary outcomes are patient reported outcomes: Groninger frailty index (GFI), quality of life (EQ-5D-5L, EORTC-QLQ-C30), shared decision making (SDM-Q-9), self-reported adherence (MARS-5), single item questions, patient experiences (PREMs), adverse events, overall survival (OS) and progression free survival (PFS). Patient reported outcomes were developed and integrated in the e-coach MM to regularly measure digitized outcomes of MM patients from time of RDMM until 12 months post-diagnosis. Online measurements will be performed at baseline (0), 3, 6, 9 and 12 months.


Eligibility criteria: Inclusion Criteria:

In order to be eligible to participate in this study, a participant (patient) must meet all of the -following criteria:

* signed informed consent
* \>18 years
* recently diagnosed MM patients with first-line or second-line treatment
* able to complete patient-reported outcome measures and experiences
* have minimal digital skills to check if they are able to interact with an e-coach
* can read and understand Dutch.

Participants who meet any of the following criteria will be excluded from participation in this study

* psychiatric illness requiring secondary-care intervention
* too ill to engage with the intervention in the opinion of the clinical care team
* no perspective of \>12 months survival.

Primary outcomes:
measure: blinded primary outcome by pill count
timeFrame: over a time periode of 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Zwolle
country: Netherlands
facility: Isala Klinieken
state: Overijssel
Study officials:
affiliation: Isala klinieken department clinical pharmacy
name: Job Eijsink, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01258270: Efficacy and Patient Satisfaction With AQUACEL® Ag Surgical Dressing Compared to Standard Surgical Dressing
Official title: Efficacy and Patient Satisfaction With AQUACEL® Ag Surgical Dressing Compared to Standard Surgical Dressing. A Prospective, Randomized Study in Primary Total Joint Arthroplasty.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wound Healing
Lead sponsor: OrthoCarolina Research Institute, Inc.
Sponsor class: OTHER
Collaborators: name: ConvaTec Inc.
First posted: 2010-12-10
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to determine the safety and effectiveness of the AQUACEL® Ag Surgical Dressing (treatment group) as compared to prepackaged island wound dressings consisting of traditional tape and gauze (control group) for total hip and total knee arthroplasty.


Eligibility criteria: Inclusion Criteria:

1. Patients presenting for primary total hip performed through a posterior or posterior-lateral surgical approach or primary total knee arthroplasty
2. Patients between the ages of 18 and 90
3. The subject is willing and able to understand, sign and date the study specific patient Informed Consent, to volunteer participation in the study
4. The subject is having surgery at a Carolinas HealthCare System facility
5. The subject is psychosocially, mentally and physically able to comply with the requirements of the study

Exclusion Criteria:

1. Patients presenting for revision total hip or total knee arthroplasty
2. Patients with topical hypersensitivity or allergy to any disposable components of the dressing system such as: ionic silver, polyurethane film
3. Any systemic or local active dermatological disease that might interfere with the evaluation of the surgical site such as eczema, psoriasis, skin cancer, scleroderma, chronic urticaria
4. Patients currently participating in another clinical trial that may affect your participation in this trial
5. Patients with insurance coverage not included in Gentiva list of payers
6. Patients residing outside of Gentiva's geographical coverage area
7. Patients having surgery at a NON-Carolinas HealthCare System facility

Primary outcomes:
measure: The incidence of postoperative severe skin reactions (defined as blisters) around the surgical incision site
timeFrame: 4 weeks postop
Secondary outcomes:
measure: Patient pain and satisfaction (1-100 visual analog scale)
timeFrame: immediate postop, 5-7 days postop, 4 weeks postop
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: OrthoCarolina, PA
state: North Carolina
Study officials:
affiliation: OrthoCarolina, PA
name: Bryan D Springer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02402270: Safety and Tolerability Study of an Edible Colon Preparation
Official title: An Adaptive, Single-Blind, Parallel, Randomized, Phase 2, Formulation Screening/Proof of Concept, Safety, Tolerability and Efficacy Study of Three Formulations/Dosing Regimens of ECP (PEG 3350) Colon Prep Kit Compared to Comparators.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bowel Preparation
Keywords: Colonoscopy
Preparation
Lead sponsor: ColonaryConcepts LLC
Sponsor class: INDUSTRY
First posted: 2015-03-30
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to learn about a new bowel preparation that uses food to clean the colon.

In order to learn about this new food preparation, some people in this study will get the food preparation, and others will get the standard liquid bowel preparation.

Patients will be randomized (like flipping a coin) to one of five groups:

Group 1 - Menu A Meal Kit - contains bars, shakes, soup, and a rice bowl Group 2 - Menu B Meal Kit - contains bars, shakes, soup, and a rice bowl Group 3 - Menu C Meal Kit - contains bars and shakes Group 4 - MoviPrep Group 5 - NuLYTELY

Detailed description: The purpose of this Phase 2 formulation screening/proof of concept study is to evaluate the safety, tolerability, and efficacy of up to 3 ECP-019 formulations/dosing regimens comprising a PEG 3350 Colon Prep Kit, containing electrolytes provided by the foods, in 3 formulations/ dosing regimens as compared to 2 comparators in a Phase 2 study.

Eligibility criteria: Inclusion Criteria:

* Patients whose physician has prescribed colonoscopy for colorectal cancer screening or surveillance for colorectal cancer.
* Patients with a previous history of completing a bowel cleansing procedure for a colonoscopy.

Exclusion Criteria:

* Known intestinal stricture of any etiology.
* History of diabetes mellitus.

Primary outcomes:
measure: The proportion of patients with successful colon cleansing as assessed by the blinded gastroenterologists using the Aronchick Scale.
timeFrame: One year
Secondary outcomes:
measure: Percentage of patients who completed each of the ECP-019 formulation/dosing regimens
timeFrame: One year
Other outcomes:
Locations:
city: Indianapolis
country: United States
state: Indiana
city: Lebanon
country: United States
state: New Hampshire
Study officials:
References:
Clinical trial NCT01084070: Early Oral Feeding Versus Traditional Postoperative Care in Emergency Abdominal Surgery
Official title: Randomized Clinical Trial of Early Oral Feeding Versus Traditional Postoperative Care in Emergency Abdominal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postoperative Care
Keywords: early feeding
postoperative care
emergency surgery
Lead sponsor: Hospital General de Agudos "Dr. Cosme Argerich"
Sponsor class: OTHER
First posted: 2010-03-10
Enrollment: 336
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The traditional postoperative care after abdominal surgery included the need of nasogastric tube, fasting until resumed bowel function and progressive reinstitution of oral intake from liquid to solid diet. Recent studies have shown no benefits of this traditional management over early oral feeding. Nevertheless, the researches in emergency surgery are scarce.


Eligibility criteria: Inclusion Criteria:

* Patients over 14 years after abdominal emergency surgery.

Exclusion Criteria:

* Lack of consensus of the patient
* Concurrent extra-abdominal surgery
* Short bowel or other clear indication of parenteral nutrition
* Inability to feed orally (eg, decreased level of consciousness)
* Interventional procedure
* Esophageal surgery
* Reoperations
* Pancreatitis

Primary outcomes:
measure: Postoperative Complications
timeFrame: At 30 days or at discharge
Secondary outcomes:
measure: Gastrointestinal leaks
timeFrame: At 30 days or at discharge
measure: Time to resume bowel functions
timeFrame: At 30 days or at discharge
measure: Oral diet intolerance
timeFrame: At 30 days or at discharge
measure: Postoperative hospital stay
timeFrame: At 90 days
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Argerich Hospital
Study officials:
affiliation: Argerich Hospital
name: Roberto F Klappenbach, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Klappenbach RF, Yazyi FJ, Alonso Quintas F, Horna ME, Alvarez Rodriguez J, Oria A. Early oral feeding versus traditional postoperative care after abdominal emergency surgery: a randomized controlled trial. World J Surg. 2013 Oct;37(10):2293-9. doi: 10.1007/s00268-013-2143-1.
Clinical trial NCT00868270: Urinary Cytokine Levels as a Prognostic Marker for Kidney Scarring After Pyelonephritis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Kidney Scarring Post-Febrile UTI
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2009-03-24
Enrollment: 35
Sex: ALL
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Hospitalized children with UTIs

Brief summary: The prevalence of kidney scarring after UTI is approximately 5-57%. UTIs are caused mainly by bacteria that cause local and systemic immunological reaction that are accompanied by cytokines. These cytokines are a main factor in the inflammatory process. They are produced by leukocytes, macrophages, fibroblasts, endothelial cells and epithelial cells in the kidney tissue. Interleukin 6 and 8 (IL-6 IL-8) were found in high levels in the urine of children and adults who suffer from UTIs. Other studies on animals have found a relationship between inflammatory reaction and scarring in the kidney. We hypothesize that we will find a similar relationship between the level of IL-6, IL-8 in the urine during acute pyelonephritis in children and the probability of kidney scarring.


Eligibility criteria: Inclusion Criteria:

* Children aged 0-7
* First episode febrile UTI

Exclusion Criteria:

* Recurrent UTI

Primary outcomes:
measure: High prevalence of kidney scarring in children with high levels of urine interleukins
timeFrame: six months
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
References:
Clinical trial NCT03303170: Non-Significant Risk Study of Sebacia Microparticles in the Treatment of Facial Acne Vulgaris
Official title: A Prospective, Multicenter, Randomized, Controlled, Evaluator-Blinded Study of the Safety and Effectiveness of Sebacia Microparticles as an Accessory to 1064 nm Nd:Yag Laser in the Treatment of Facial Inflammatory Acne Vulgaris
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acne Vulgaris
Lead sponsor: Sebacia, Inc.
Sponsor class: INDUSTRY
First posted: 2017-10-05
Enrollment: 168
Sex: ALL
Minimum age (years): 12
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Prospective, randomized, controlled, parallel group clinical study with blinded assessment evaluating Sebacia Microparticles (SM) with Nd:Yag laser in facial inflammatory acne vulgaris


Eligibility criteria: Inclusion Criteria:

* Mild to moderate acne vulgaris
* At least 15 inflammatory acne lesions
* Skin phototype I - III
* Able to understand and comply with study requirements

Exclusion Criteria:

* Severe acne vulgaris
* Nodulocystic acne
* Ongoing use of medications and/or treatments for acne
* New hormone regimen (used for less than 12 weeks)
* Significant medical or mental health condition

Primary outcomes:
measure: Change in number of inflammatory acne lesions
timeFrame: Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Clear Dermatology & Aesthetics Center
state: Arizona
city: San Diego
country: United States
facility: Scripps Health
state: California
city: Miami
country: United States
facility: Miami Dermatology & Laser Institute
state: Florida
city: Savannah
country: United States
facility: Meridian Clinical Research
state: Georgia
city: Saint Joseph
country: United States
facility: MediSearch Clinical Trials
state: Missouri
city: Charlotte
country: United States
facility: Dermatology, Laser & Vein Institute
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates
state: North Carolina
city: Murfreesboro
country: United States
facility: International Clinical Research
state: Tennessee
city: Austin
country: United States
facility: Austin Institute for Clinical Research
state: Texas
city: Katy
country: United States
facility: The Center for Skin Research
state: Texas
city: Spokane
country: United States
facility: Premier Clinical Research
state: Washington
Study officials:
References:
Clinical trial NCT02972970: Feasibility Study to Assess the Scan, Fit and Print Process for the Aveera "Patient Matched" CPAP Mask
Official title: Feasibility Study to Assess the Scan, Fit and Print Process for the Aveera "Patient Matched" CPAP Mask
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: Metamason
Sponsor class: INDUSTRY
First posted: 2016-11-25
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Feasibility study to assess the scan, fit and print process for the Aveera "Patient Matched" CPAP Mask

Detailed description: 1. Assess the process of scan, fit and print
2. Subjective/objective assessment of fit of the Aveera during the 2 week use for leaks and comfort
3. Ethnographic insights into the user experience of the scan, fit, print process.

Eligibility criteria: Inclusion Criteria:

* ≥ 18 years of age
* Both genders
* Currently prescribed fixed pressure CPAP or APAP for the treatment of OSA
* Currently CPAP pillows and nasal mask users
* Patients who are adherent as defined by conventional standards (i.e. 4 hours per night/70% of the nights)

Exclusion Criteria:

* Unwilling to wear the AVEERA
* Concern about privacy of data
* Pregnant
* Full face mask user
* Any medical condition deemed by the investigator to pose an issue with the subject's participation.
* Upper limit of CPAP pressure of ≥ to 15 cm H20 or APAP a upper limit pressure setting of ≥17cm H2O
* Requires the use of supplemental oxygen

Primary outcomes:
measure: 1) Measure time frame from scanning to mask fit and subjective patient feedback of mask fit
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Tower Sleep Medicine
state: California
Study officials:
affiliation: Consultant
name: robyn woidtke
role: STUDY_DIRECTOR
References:
Clinical trial NCT04649970: Antegrade Double-J Stent Placement for the Treatment of Malignant Obstructive Uropathy
Official title: Antegrade Double-J Stent Placement for the Treatment of Malignant Obstructive Uropathy: a Single Center Experience
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urologic Neoplasms
Lead sponsor: Université de Sousse
Sponsor class: OTHER
First posted: 2020-12-02
Enrollment: 174
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 174 patients (sexe ratio = 0.51, age range 9-91 years; mean age, 54 years) were included in the study.

Brief summary: Ureteral double- J stent is usually inserted by retrograde approach for the treatment of obstructed upper urinary tract. The antegrade approach, can a suitable alternative in certain situations without the need for general or spinal anesthesia. The present study demonstrates the indications, success rate, and complications of this approach in the treatment of malignant obstructive uropathy.

Detailed description: Data of consecutive patients in whom antegrade ureteral stent¬ing was performed between January 2013 and February 2020 were retrospectively analysed using patient records and radiology reports. A total of 174 patients (sexe ratio = 0.51, age range 9-91 years; mean age, 54 years) were included in the study.

Ureteral obstruction was caused by bladder cancer (n=92), uterin cancer (n=31), prostate cancer (n=28), colorectal cancer (n= 15) and retroperitoneal tumor (n= 8) (Table 1).

Eligibility criteria: Inclusion Criteria:

* malignant uropathy obstruction

Exclusion Criteria:

* benign uropathy obstruction

Primary outcomes:
measure: number of patient having Antegrade double-J stent placement for the treatment of malignant obstructive uropathy
timeFrame: 7 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: university of sousse
name: ghaassen tlili, PROFESSOR
role: STUDY_DIRECTOR
References:
citation: Tlili G, Ammar H, Dziri S, Ben Ahmed K, Farhat W, Arem S, Acacha E, Gupta R, Rguez A, Jaidane M. Antegrade double-J stent placement for the treatment of malignant obstructive uropathy: A retrospective cohort study. Ann Med Surg (Lond). 2021 Aug 16;69:102726. doi: 10.1016/j.amsu.2021.102726. eCollection 2021 Sep.
Clinical trial NCT04568070: Turkish Version of the Mini-BESTest: Transcultural Adaptation and Validation Study in Stroke Patients
Official title: Turkish Version of the Mini-BESTest: Transcultural Adaptation and Validation Study in Stroke Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Balance; Distorted
Keywords: balance
stroke
validity
reliability
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
First posted: 2020-09-29
Enrollment: 50
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: "mini-BESTest (Turkish version)", "Berg Balance Test", "Timed Up and Go Test" and "Functional Reach Test" will be used for balance measurement in patients and the correlation of the mini-BEST with these tests will be checked.

Detailed description: The first part of the study is the Turkish translation of mini-BESTest. After the translation process, "mini-BESTest (Turkish version)", "Berg Balance Test", "Timed Up and Go Test" and "Functional Reach Test" will be used for balance measurement in patients and the correlation of the mini-BEST with these tests will be checked. All tests will be applied by 2 researchers on the same day, 2 times with 10 minutes intervals.

Eligibility criteria: Inclusion Criteria:

1. Chronic stroke patients
2. Patients who can execute commands
3. Patients who are ambulatory enough to complete most balance tasks
4. Patients participating in the study voluntarily

Exclusion Criteria:

1. Acute stroke patients
2. Patients who cannot execute commands
3. Non-ambulatory patients
4. Pediatric patients and pregnant patients

Primary outcomes:
measure: mini-BESTest
timeFrame: 3 months
measure: Berg Balance Scale
timeFrame: 3 months
measure: Timed Up and Go Test
timeFrame: 3 months
measure: Functional Reach Test
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medeniyet University Faculty of Medicine, Physical Medicine and Rehabilitation Department
Study officials:
affiliation: Istanbul Medeniyet University Physical Therapy And Rehabilitation Department
name: Bilinç Karatekin
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05370170: Ottawa Nutritional Guidelines for Nausea and Vomiting
Official title: Effect of Implementing Ottawa Nutritional Guidelines on the Course of Nausea and Vomiting During Pregnancy (A Randomized Control Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nausea Gravidarum
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-05-11
Enrollment: 60
Sex: FEMALE
Minimum age (years): 22
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Effect of Implementing Ottawa Nutritional Guidelines on the Course of Nausea and Vomiting During Pregnancy (A Randomized Control Trial)

Detailed description: Studying the Effect of Implementing Ottawa Nutritional Guidelines on the Course of Nausea and Vomiting During Pregnancy (A Randomized Control Trial) using no pharmacological agents and life style modification in addition to acupressure to treat nausea and vomiting of pregnancy

Eligibility criteria: Inclusion Criteria:

1. primigravida
2. gestational age of 7-13 weeks
3. singleton pregnancy
4. having a score of 7-12 on the (PUQE 24)
5. can read and write
6. having phone number
7. not receiving medications for reducing NVP, except for vitamin B6
8. wanted pregnancy.

Exclusion Criteria:

1. subject's unwillingness to continue the study
2. occurrence of obstetric complications during the study
3. hyper-emesis gravidarum
4. having physical or mental disorders
5. having oral/speech impairments
6. having assisted reproductive techniques for the present pregnancy
7. having two consecutive miscarriages before the current pregnancy
8. old primigravida
9. narcotic use or alcohol drinking
10. and subjects who will show signs and symptoms of hyperemesis gravidarum during the study will be dropped out and referred to medical care.

Primary outcomes:
measure: control nausea and vomiting
timeFrame: 3 weeks
Secondary outcomes:
measure: maintain normal body weight and prevent hospitalization
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Nursing
Study officials:
affiliation: Cairo University
name: Noura Mo Eltoukhi, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Nursing Cairo University
name: Noura M Eltoukhi, lecturer
role: PRINCIPAL_INVESTIGATOR
References: