louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03216486: An Exploratory Study of BPS804 Treatment in Adult Patients With Type I, III or IV Osteogenesis Imperfecta
Official title: A Phase 2, Non-controlled, Open-Label, Exploratory Study of BPS804 Treatment in Adult Patients With Type I, III or IV Osteogenesis Imperfecta
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Osteogenesis Imperfecta
Lead sponsor: Ultragenyx Pharmaceutical Inc
Sponsor class: INDUSTRY
Collaborators: name: Mereo BioPharma
First posted: 2017-07-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm, open-label
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the effect of BPS804 on strength/quality of bone in patients with Type I, III or IV Osteogenesis imperfecta using a special type of CT scanner. Participants will be treated for 1 year.

Detailed description: This study was previously posted by Mereo Biopharma and was transferred to Ultragenyx in February 2021.

Eligibility criteria: Inclusion Criteria:

* Patients with a clinical diagnosis of OI Type I, III or IV
* Capable of giving signed consent

Exclusion Criteria:

* History of skeletal malignancies or other bone diseases (other than OI)
* History of endocrine or thyroid/parathyroid conditions that could affect bone metabolism
* Treatment with bisphosphonates within 3 months of randomisation
* Treatment with teraparatide, denosomab or other anabolic/antiresorbative medications within 6 months of randomisation

Primary outcomes:
measure: Change in radial Trabecular Volumetric Bone Mineral Density (mgHA/cm3)
timeFrame: 12 months
measure: Change in radial bone strength on Finite Element Analysis (N)
timeFrame: 12 months
Secondary outcomes:
measure: Change in tibial Trabecular Volumetric Bone Mineral Density (mgHA/cm3)
timeFrame: 12 months
measure: Change in tibial bone strength on Finite Element Analysis (N)
timeFrame: 12 months
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: Mereo Investigator Site
state: New Mexico
city: Houston
country: United States
facility: Mereo Investigator Site
state: Texas
Study officials:
affiliation: Ultragenyx Pharmaceutical Inc
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03462186: Promoting Patient Engagement in Clinical Preventive Services: Evaluating the Use of Healthfinder
Official title: Promoting Patient Engagement in Clinical Preventive Services: Evaluating the Use of Healthfinder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Knowledge, Attitudes, Practice
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2018-03-12
Enrollment: 1092
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Clinical preventive services (CPS) are fundamental to early disease detection and improvement of health outcomes but are often poorly understood and utilized by patients. Myhealthfinder is a web-based tool developed by the Office of Disease Prevention and Health Promotion (https://healthfinder.gov). This study tests the "prescription" of myhealthfinder to engage patients in CPS, improve patient-clinician communication and increase uptake of CPS.


Eligibility criteria: Inclusion Criteria:

* Scheduled wellness appointment with primary care provider

Exclusion Criteria:

* Inability to read English

Primary outcomes:
measure: Uptake of clinical preventive services
timeFrame: 3 months
measure: Change in communication and health knowledge
timeFrame: Immediately after the intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Sebastian Tong, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04529486: Kinesio Taping in Cerebral Palsy Upper Extremity Functionality
Official title: Effects of Kinesio Taping on Upper Extremity Functionality in Participants With Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: Kinesiotape
Cerebral palsy
upper extremity functionality
Lead sponsor: Baskent University
Sponsor class: OTHER
First posted: 2020-08-27
Enrollment: 14
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The children with Cerebral Palsy included in this study consisted of 2 groups, the study group and the control group. No application was made to the control group. The same participant group was included as the experimental group after 1 week of rest. The assessments were done three times for each group (beginning - 45min later - 1 week later)
Primary purpose: TREATMENT

Brief summary: Purpose: The aim of this study is to investigate the effects of kinesio taping on upper extremity functionality in participants with Cerebral Palsy.

Methods: This study included 14 children aged 6-16 years, diagnosed with Cerebral Palsy. The children with Cerebral Palsy were divided into 2 groups, the study group and the control group. Assessments were done three times for each group (beginning - 45min later - 1 week later). Frenchay Arm Test was used to evaluate upper extremity functionality in participants with Cerebral Palsy. Kinesio taping was applied to study group to improve posture and function in shoulder area.


Eligibility criteria: Inclusion criteria were as follows;

* To have a cognitive level to comprehend the instructions
* Not having a cooperative problem that may prevent communication
* Continuing special education regularly Exclusion criteria were as follows;
* Those with orthopedic problems
* Any surgical procedure
* Participants with cognitive problems
* Participants who do not regularly receive physiotherapy

Primary outcomes:
measure: Upper extremity functionality
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Baskent University
Study officials:
affiliation: Baskent University
name: Nihan O Pekyavas
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05968586: Non-Invasive Neurally Adjusted Ventilatory Assist (NAVA) Prone vs Supine in Premature Infants
Official title: Effect of Body Position on Oxygenation, Ventilation, and Diaphragmatic Workload in Premature Infants on Non-Invasive Neurally Adjusted Ventilatory Assist (NAVA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neonatal Oxygen Desaturation
Premature
Ventilator Lung; Newborn
Apnea of Prematurity
Keywords: apnea of prematurity
NAVA
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2023-08-01
Enrollment: 30
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This research study is being done to investigate the effect of changing an infant's body position on how hard the baby works to breathe, the baby's oxygen level, the baby's carbon dioxide level, the baby's lung volume, the baby's lung compliance (ability of the lung to expand and fill with air), and how frequently the baby develops clinically significant events such as apnea (baby stops breathing on his own), bradycardia (low heart rate), and desaturation (low oxygen) events.


Eligibility criteria: Inclusion Criteria:

* Viable infants born at ≤32 weeks of gestation on non-invasive NAVA.
* Infant must be stable on NAVA for at least 24 hours prior to the study

Exclusion Criteria:

* Infants with congenital heart disease (CHD)
* Infants with persistent pulmonary hypertension (PPHN)
* Infants with contraindications to using NAVA (e.g. neuromuscular blockage or paralysis, absent electrical signal from the diaphragm, esophageal tears or bleeding, cardiac pacemakers) or infants in whom an NG/OG catheter cannot be placed.

Primary outcomes:
measure: Peak electrical activity of the diaphragm (Edi peaks)
timeFrame: From enrollment in study to end of study (a total of twelve hours)
measure: Minimum electrical activity of the diaphragm (Edi mins)
timeFrame: From enrollment in study to end of study (a total of twelve hours)
measure: Number of apenic events
timeFrame: From enrollment in study to end of study (a total of twelve hours)
measure: Number of bradycardia events
timeFrame: From enrollment in study to end of study (a total of twelve hours)
measure: Number of desaturation events
timeFrame: From enrollment in study to end of study (a total of twelve hours)
Secondary outcomes:
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Health Milton S Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Penn State College of Medicine
name: Kristin Glass, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02383186: Dermal Suturing Only Versus Layered Cutaneous Closure
Official title: Dermal Suturing Only Versus Layered Cutaneous Closure: A Randomized Split Wound Comparative Effectiveness Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Wound Closure Techniques
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2015-03-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine whether a single layer dermally sutured wound results in superior outcomes to a layered closure.

Detailed description: The purpose of this study is to determine whether a single layer dermally sutured wound results in superior outcomes to a layered closure. Our aims are to compare outcomes using a split wound model, where half the wound is sutured with one technique and the other half is sutured with the other. This will be measured via the physician observer scar assessment scale, a validated scar instrument and via wound width. Our hypothesis is that wounds with a single layer closure will result in cosmetically superior wound outcomes.

Eligibility criteria: Inclusion Criteria:

* Able to give informed consent themselves
* Patient scheduled for cutaneous surgical procedure with predicted linear closure
* Willing to return for follow up visits

Exclusion Criteria:

* Mentally handicapped
* Incarceration
* Pregnant Women
* Wounds with predicted closure length less than 3 cm
* Wounds unable to be fully closed via primary closure

Primary outcomes:
measure: Assessment of Scar on the Patient and Observer Scar Assessment Scale at 3 Months
timeFrame: 3 months
measure: Assessment of Scar on the Patient and Observer Scar Assessment Scale at 12 Months
timeFrame: 12 months
Secondary outcomes:
measure: Measurement of Scar Width
timeFrame: 3 months and 12 months
measure: Assessment of Complications
timeFrame: 3 months and 12 months
Other outcomes:
Locations:
Study officials:
affiliation: University of California, Davis
name: Daniel Eisen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04366986: International Registry of Coronavirus (COVID-19) Exposure in Pregnancy
Official title: International Registry of Coronavirus Exposure in Pregnancy (IRCEP)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid-19
Lead sponsor: Pregistry
Sponsor class: INDUSTRY
Collaborators: name: Harvard School of Public Health (HSPH)
First posted: 2020-04-29
Enrollment: 17318
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women, or women who have been pregnant in the last 6 months, who were tested for SARS-CoV-2 (regardless of the result) or were clinically diagnosed with COVID-19 by a health care professional.

Brief summary: The International Registry of Coronavirus Exposure in Pregnancy (IRCEP) is a prospective cohort study of pregnant and recently pregnant women who have been tested for SARS-CoV-2 (regardless of the result) or have been clinically diagnosed with COVID-19 by a health care professional. Data from the IRCEP will be used to evaluate the impact of COVID-19 on pregnancy and birth outcomes.

Detailed description: The International Registry of Coronavirus Exposure in Pregnancy (IRCEP) will enroll women 18 years of age and older who are currently pregnant or have been pregnant women within the last 6 months, and who have been tested for SARS-CoV-2 (regardless of the result) or have been clinically diagnosed with COVID-19 by a health care professional. As this is an international registry, women from all countries are welcome to participate.

Women will enroll and provide information to the IRCEP via website and mobile app. After signing the electronic informed consent document, registrants will answer questions on the following modules: Demographics, Reproductive History, Height and Weight, Habits, Health Conditions, Medications, Current Pregnancy, COVID-19 Infection Test, and COVID-19 Infection Symptoms. Monthly follow-up modules will continue until the pregnancy outcome. In case of a live birth, the Registry participant will continue with the Post-Partum Outcomes module until the newborn is 90 days of age. Medical records from the mother and neonate will also be requested.

Eligibility criteria: Inclusion Criteria:

* Pregnant women or women who have been pregnant within the last 6 months
* Able to give electronic informed consent
* Tested for SARS-CoV-2 (regardless of the result) or clinically diagnosed with COVID-19 by a health care professional

Exclusion Criteria:

* \<18 years of age

Primary outcomes:
measure: Pregnancy outcomes
timeFrame: 1 year
measure: Birth outcomes
timeFrame: Birth to 90 days post-partum
measure: Birth outcomes
timeFrame: Birth to 90 days post-partum
measure: Birth outcomes
timeFrame: Birth to 90 days post-partum
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Pregistry
state: California
Study officials:
affiliation: CEO Pregistry
name: Diego Wyszynski, MD, MHS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00829686: Trial of Antibiotic Treatment for Skin Abscess in Patients at Risk for Methicillin-Resistant Staphylococcus Aureus (MRSA) Infection
Official title: Prospective Randomized Controlled Trial of Antibiotic Treatment for Uncomplicated Skin Abscess in Patients at Risk for Community Acquired Methicillin-Resistant Staphylococcus Aureus Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abscess
Keywords: abscess
cellulitis
antibiotics
MRSA
Lead sponsor: 59th Medical Wing
Sponsor class: FED
First posted: 2009-01-27
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients will be enrolled in a multi-center study to prospectively evaluate outcome after treatment for an uncomplicated skin abscess. All patients will receive incision and drainage and wound cultures. Patients will then be randomized to 1)no antibiotic or 2) bacterium double strength (DS) (800/160) two tablets per oral (PO) twice a day x 7 days. This is the dose recommended for treating skin and soft tissue infections. (Ellis et al. Current Opinion in Infectious Diseases. 18(6):496-501, December 2005) Patients will then return to the emergency room (ER) on days 3 and 7 for wound repacking and evaluation. The primary outcome is clinical cure of abscess at 7 days after incision and drainage and recurrence rates within 30 days of treatment. Patients who are not improving at the following visit will then be treated with additional antibiotics or admission if needed. Data will be analyzed both by initial randomization and intention to treat. This serves as the pilot for the full placebo controlled randomized trial.


Eligibility criteria: Inclusion Criteria:

* all patients age 18-55 who present to the emergency department with a skin abscess that requires incision and drainage.

Exclusion Criteria:

* patients with diabetes, HIV, cancer or other immunocompromised patients
* patients who received antibiotics within one week of presentation or were hospitalized in previous month will be excluded to minimize potential confounding variables
* pregnant and breastfeeding patients will also be excluded due to possible safety concerns with antibiotic treatment
* basic Military Trainees will also be excluded from participation
* patients with abscesses on head, face, perirectal, or periananal regions, abscesses with known tracks or fistulas to deeper structures, or abscesses requiring surgical drainage in an operating room are excluded
* patients with sulfa allergy will be excluded.

Primary outcomes:
measure: Clinical Improvement at 7 Days After Incision and Drainage
timeFrame: 7 days
Secondary outcomes:
measure: Recurrence Rates
timeFrame: 30 days
Other outcomes:
Locations:
city: Lackland Air Force Base
country: United States
facility: Wilford Hall Medical Center
state: Texas
Study officials:
References:
Clinical trial NCT04231786: Breast Ultrasonography and Polycystic Ovary Syndrome
Official title: Breast Ultrasonography Findings in Patients Over 30 Years With Polycystic Ovary Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Diseases
Polycystic Ovary
Keywords: breast diseases
fibrocystic breast
polycystic ovari syndrome
fibroadenoma
Lead sponsor: Kanuni Sultan Suleyman Training and Research Hospital
Sponsor class: OTHER
First posted: 2020-01-18
Enrollment: 1
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients over 30 years of age diagnosed with polycystic ovary syndrome breast ultrasonography findings in these patients

Brief summary: The results of the evaluation of breast ultrasonography results of patients with polycystic ovary syndrome diagnosis over 30 years of age will be evaluated.

Patients admitted to the outpatient clinic and rotterdam criteria according to laboratory data and polycystic ovary syndrome patients diagnosed by the same radiologist the next day after the end of menstrual breast ultrasonography. The aim of this study is to show the association of polycystic ovary syndrome and fibrocystic breast.


Eligibility criteria: Inclusion Criteria:

* Over 30 years
* diagnosed with polycystic ovary syndrome according to rotterdam criteria
* no previous history of breast disease
* female patients

Exclusion Criteria:

* Under 30 years
* polycystic ovary syndrome
* patients with a previously known history of breast disease

Primary outcomes:
measure: Breast ultrasonography findings
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Kanuni Sultan Süleyman Training and Research Hospital
Study officials:
References:
Clinical trial NCT04437186: The Effectiveness of a Recovery Program for People With Mental Illness: A Multicenter Study
Official title: The Effectiveness of a Recovery Program for People With Mental Illness: A Multicenter Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Illness
Lead sponsor: National Cheng-Kung University Hospital
Sponsor class: OTHER
First posted: 2020-06-18
Enrollment: 48
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Recovery-oriented approach has been the main trend in mental health field. However, few recovery-oriented programs are available in Taiwan, and many Taiwanese people with mental illness don't understand the concepts of recovery. A program which provides recovery knowledge and assists in setting recovery goals is beneficial for Taiwanese people with mental illness. Hence, this study aimed to investigate the effectiveness of a recovery program for people with mental illness.

Detailed description: This is a randomized control trial. Participants will be recruited from the psychiatric rehabilitation organizations in Taiwan. They will be randomly assigned to the intervention group or control group. The recovery program has 2 phases and consists of 20 classes, 1.5 hour per class and one class per week. We will introduce concepts of recovery and personal strengths in phase 1. Then, we will help participants to set goals and implement their plans in phase 2. Participants will fill out five questionnaires during the recruitment meeting, including Stages of Recovery Scale, Medical Outcomes Study Social Support Survey, The Hope Scale, Rosenberg Self-Esteem Scale and Brief Symptom Rating Scale-50. They will fill out the same questionnaires plus the course satisfaction survey in the end of phase 1 and 2. Six months later, participants will receive a follow-up interview and fill out the questionnaires again. The control group will receive a spiritual book and complete the questionnaires at the same time as the intervention group.

Eligibility criteria: Inclusion Criteria:

* diagnosis of mental illness
* lived in community

Exclusion Criteria:

-

Primary outcomes:
measure: Stages of Recovery Scale (SRS)
timeFrame: Change from Baseline at 10 weeks, 20 weeks and 44 weeks
Secondary outcomes:
measure: Medical Outcomes Study Social Support Survey (MOS-SS)
timeFrame: Change from Baseline at 10 weeks, 20 weeks and 44 weeks
measure: The Hope Scale (THS)
timeFrame: Change from Baseline at 10 weeks, 20 weeks and 44 weeks
measure: Rosenberg Self-Esteem Scale (RSE)
timeFrame: Change from Baseline at 10 weeks, 20 weeks and 44 weeks
measure: Brief Symptom Rating Scale-50 (BSRS-50)
timeFrame: Change from Baseline at 10 weeks, 20 weeks and 44 weeks
Other outcomes:
measure: Qualitative data
timeFrame: At 10 weeks, 20 weeks and 44 weeks
Locations:
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
Study officials:
References: