louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04505891: Enhanced Kidney Follow-up for AKI Survivors in Care Transitions
Official title: Enhanced Kidney Follow-up for AKI Survivors in Care Transitions (The ACT Study): Impact on Patient Reported Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Kidney Injury
Keywords: transitions of care
education
patient reported outcomes
chronic kidney disease
acute kidney injury
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-08-10
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to assess the ability of education and outpatient kidney care follow-up in order to improve patient knowledge about acute kidney injury (AKI).


Eligibility criteria: Inclusion Criteria:

* KDIGO Stage 3 AKI
* Primary care provider at Mayo Rochester.

Exclusion Criteria:

* Patient with need for dialysis at discharge from hospital or hospice.
* Enrolled in the Primary Care Transition Program.
* Non-English speaking.
* Cognitive impairment.
* Dementia.
* Mini-Cog score of less than 3.

Primary outcomes:
measure: Modified Kidney Knowledge Survey (mKIKS)
timeFrame: 14-days after last study contact
Secondary outcomes:
measure: Brief health literacy screen
timeFrame: 30-days post hospitalization
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health 10
timeFrame: 30-days post hospitalization
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Erin F Barreto, PharmD, RPh
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06262191: Testing an Adjustable Ankle Orthosis During Walking in Cerebral Palsy
Official title: An Adjustable Stiffness Orthosis to Maintain Muscle Engagement and Push-off Power in Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Cerebral Palsy
Lead sponsor: Northern Arizona University
Sponsor class: OTHER
First posted: 2024-02-15
Enrollment: 11
Sex: ALL
Minimum age (years): 8
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study seeks to determine how an adjustable stiffness ankle braces affects walking performance and biomechanics in cerebral palsy.

Detailed description: Our first aim is to confirm that the differential and adjustable stiffness (DAS) AFO improves plantarflexor push-off power and range of motion compared to standard (physician prescribed) AFOs during walking in CP.

Our second aim is to confirm that the differential and adjustable stiffness (DAS) AFO improves plantarflexor muscle activity while maintaining improved posture compared to standard AFOs during walking in CP.

Our third aim is to validate the need and usability of real-time stiffness adjustment during play and school activities; obtain feedback from the children, their parents, and orthotists to design the MVP.

Eligibility criteria: Inclusion Criteria:

* Age between 8-35 years old, inclusive
* Diagnosis of cerebral palsy (CP)
* Gross motor functional classification score level I, II, or III
* Physician-prescribed AFOs of common design (i.e., rigid molded thermoplastic)
* Ability to walk for 6 minutes on a treadmill
* At least 20° of passive plantar-flexion range of motion
* No concurrent treatment other than those assigned during the study
* No condition other than CP that would affect safe participation
* No surgery within 6 months of participation.

Exclusion Criteria:

-Excessive knee flexion during walking caused by CP

Primary outcomes:
measure: Change in Muscle Activity
timeFrame: day 1
measure: Change in Metabolic Cost of Transport
timeFrame: day 1
measure: Change in Ankle Power
timeFrame: 1 day during walking
Secondary outcomes:
Other outcomes:
Locations:
city: Flagstaff
country: United States
facility: Northern Arizona University
state: Arizona
Study officials:
References:
Clinical trial NCT01215591: Trial of Weaning of Nasal Continuous Positive Airway Pressure (CPAP)
Official title: Randomized Controlled Trial of Gradual Versus Sudden Weaning From Nasal CPAP in Preterm Neonates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preterm Neonates
Keywords: Neonatal
Nasal CPAP
Randomized controlled trial
Weaning
Lead sponsor: Maimonides Medical Center
Sponsor class: OTHER
First posted: 2010-10-06
Enrollment: 56
Sex: ALL
Minimum age (years): 24
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the 2 methods of weaning of nasal CPAP in premature babies born at 32 weeks or less

Detailed description: Objective: To study the weight and the post menstrual age (PMA) at the time of nasal CPAP (NCPAP) wean utilizing the method of sudden wean as compared to gradual wean. . Methods: A prospective randomized trial was conducted comparing sudden weaning with gradual weaning from NCPAP in neonates with gestational age (GA) \<32 weeks. The patients were randomized to one of the two methods of weaning from NCPAP and their success was compared.

Eligibility criteria: Inclusion Criteria:

All babies born with GA \<32 weeks admitted to the neonatal intensive care units at the Maimonides Infant and Children's Hospital, between 1st January 2008 and 31st March 2009 and required to be on NCPAP for longer than 48 hours.-

Exclusion Criteria:

Those with severe congenital anomalies and chromosomal defects including congenital heart disease and neurological malformations, chest wall or airway abnormalities and lung hypoplasia, were excluded from the cohort

Primary outcomes:
measure: Weight when preterm neonates could come off nasal CPAP
timeFrame: During the initial NICU stay
measure: Post-menstrual age when preterm neonates could come off nasal CPAP
timeFrame: During the initial NICU stay
Secondary outcomes:
measure: Weights when the neonates could come off oxygen
timeFrame: During the initial NICU stay
measure: length of stay in the hospital
timeFrame: During the initial NICU stay
measure: Post-menstrual age when preterm neonates could come off oxygen
timeFrame: During the initial NICU stay
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: Maimonides Medical Center
state: New York
Study officials:
affiliation: Maimonides Medical Center
name: Shantanu Rastogi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Maimonides Medical Center
name: Alok Bhutada, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00848991: Comparison of Propofol to Precedex With Propofol for Emergence and Recovery in Patients Having Craniotomy Surgery
Official title: Comparison of Propofol Standard Anesthetic to Precedex With Propofol for Emergence and Recovery in Patients Having Craniotomy Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Cranitomy Surgery
Keywords: precedex
propofol
Lead sponsor: The Cooper Health System
Sponsor class: OTHER
First posted: 2009-02-23
Enrollment: 15
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Primary Hypothesis: The use of a Precedex infusion, in addition to propofol during surgery, will improve patient management through the anesthesia postoperative recovery period determined by improvement in patients? tolerance of the endotracheal tube.

Secondary hypothesis: The use of a Precedex infusion, in addition to propofol during surgery will provide improved hemodynamic stability.

Detailed description: The purpose of this study is to compare the addition of Precedex to a propofol intravenous anesthetic for emergence from anesthesia in patients having craniotomy surgery for brain tumors.

Eligibility criteria: Inclusion Criteria:

* ASA status 1, 2, and 3

Exclusion Criteria:

* ASA status 4 and 5 patients
* Patients with positive pregnancy tests

Primary outcomes:
measure: The use of Precedex for craniotomy surgery offers the potential for improved hemodynamic control and improved tolerance of the endotracheal tube, therefore potentially benefiting these patients.
timeFrame: 4 hours after awaking from surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Camden
country: United States
facility: Cooper University Hospital
state: New Jersey
Study officials:
affiliation: The Cooper Health System
name: Michael Misbin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05227391: Live Birth After Letrozole-stimulated Cycles Versus Hormone Replacement Treatment Cycles for the First Frozen Embryo Transfer in Women With PCOS
Official title: Live Birth After Letrozole-stimulated Cycles Versus Hormone Replacement Treatment Cycles for the First Frozen Embryo Transfer in Women With PCOS: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: PCOS
Lead sponsor: Reproductive & Genetic Hospital of CITIC-Xiangya
Sponsor class: OTHER
First posted: 2022-02-07
Enrollment: 1078
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multicenter randomized controlled trial comparing the efficacy and safety of two endometrial preparation protocols for the first frozen embryo transfer cycle in PCOS with whole embryo freezing. Subjects will be randomized to letrozole-stimulated group or hormone replacement treatment group in their first frozen embryo transfer cycle, and their pregnancy and perinatal outcomes during this cycle will be followed up and analysis.


Eligibility criteria: Inclusion Criteria:

* 1. women diagnosed with PCOS according to modified Rotterdam criteria;
* 2. Women who are participating in their first cycle of IVF or ICSI.
* 3. Women whose IVF/ICSI ovarian stimulation protocol was either GnRH antagonist protocol or long agonist protocol.
* 4. Women with whole embryos freezing.
* 5. Women aged 20 to 38 years old;
* 6. Women BMI 18 kg/m2 to 30 kg/m2
* 7. Women with at least one good-quality embryo suitable for transfer, including day 3 cleavage stage embryo with grade 7CI /8CI and day 5 or day 6 blastocyst with grade 4BB or higher.

Exclusion Criteria:

* 1. Women who has a history of recurrent spontaneous abortion.
* 2. Women with unilateral/bilateral oophorectomy.
* 3. Women with untreated Hydrosalpinx.
* 4. Women with a uterine cavity abnormality, such as a uterine congenital malformation, untreated uterine septum (except shallow uterine septum), adenomyosis, submucous myoma, or moderate to severe intrauterine adhesions.
* 5. Women with uncontrolled diabetes mellitus, thyroid disease and hypertension.
* 6. Women who are indicated and planned to undergo preimplantation genetic test (PGT).

Primary outcomes:
measure: Live birth rate
timeFrame: 11 months
Secondary outcomes:
measure: Clinical pregnancy rate
timeFrame: 2 months
measure: Biochemical pregnancy rate
timeFrame: 1.5 months
measure: Miscarriage rate
timeFrame: 9 months
measure: Cycle cancellation rate
timeFrame: 1 month
measure: Birth weight
timeFrame: 11 months
measure: Incidence of obstetric and perinatal complications
timeFrame: 11 months
measure: Incidence of neonatal complications
timeFrame: 11 months
measure: Ectopic pregnancy rate
timeFrame: 2 months
Other outcomes:
Locations:
city: Changsha
country: China
facility: Reproductive & Genetic Hospital of CITIC-Xiangya
state: Hunan
Study officials:
References:
Clinical trial NCT02883491: Pulmonary Embolism Short-term Clinical Outcomes Registry
Official title: Pulmonary Embolism Short-term Clinical Outcomes Registry (PE-SCOR)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Embolism
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2016-08-30
Enrollment: 815
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who present to the Emergency Department (ED) with image confirmed acute pulmonary embolism diagnosed within 12 hours of presentation.

Brief summary: The overall goal of this clinical research study is to prospectively assess primary outcomes related to pulmonary embolism (PE) that occur immediately (within 5 days) and within 30 days. The secondary goal is to compare validated prediction models and a modified European Society of Cardiology (ESC) approach that is primarily right ventricle dysfunction (RVD) driven with clinical risk assessment being secondary, and with primary outcomes of clinical deterioration within 5 days.

Detailed description: The investigators wish to develop the Pulmonary Embolism Short-term Clinical Outcomes Registry (PE-SCOR). The investigators also wish to determine the incidence of death and circulatory and respiratory deterioration, and administration of reperfusion therapy within 5 days in PE patients. The study will also evaluate the sensitivity, specificity and positive and negative predictive values of each RVD assessment option. The investigators will also derive a prediction model for PE patients for the primary outcome within five days. Finally, investigators will determine the functional outcomes of PE patients 30 days after PE.

Eligibility criteria: Inclusion Criteria:

* Patients 18 years or older with image confirmed acute pulmonary embolism diagnosed within 12 hours of ED presentation will be eligible for enrollment.

Exclusion Criteria:

* Patients who refuse consent for 30-day clinical contact and follow-up.

Primary outcomes:
measure: Clinical Deterioration
timeFrame: 5 days
measure: Right ventricular dysfunction (RVD)
timeFrame: Index visit
Secondary outcomes:
measure: Functional Outcome
timeFrame: 30 days
measure: Pulmonary Embolism Complications
timeFrame: 30 days
Other outcomes:
Locations:
city: San Diego
country: United States
facility: San Diego Medical Center
state: California
city: Newark
country: United States
facility: Christiana Care Health System
state: Delaware
city: Orlando
country: United States
facility: Orlando Regional Medical Center
state: Florida
city: Charlotte
country: United States
facility: Carolinas Healthcare System
state: North Carolina
city: Nashville
country: United States
facility: Vanderbilt Medical Center
state: Tennessee
city: Salt Lake City
country: United States
facility: University of Utah Hospital
state: Utah
Study officials:
affiliation: Wake Forest University Health Sciences
name: Anthony Weekes, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00269191: A Study to Assess the Safety and Efficacy of an Investigational Drug in Patients With Osteoarthritis (0663-071)(COMPLETED)
Official title: A 12-Week, Randomized, Placebo- and Active-Comparator-Controlled, Parallel-Group, Double-Blind Study to Assess the Safety and Efficacy of Etoricoxib 30 mg Versus Ibuprofen 2400 mg in Patients With Osteoarthritis (Study 1)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis
Keywords: Arcoxia
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2005-12-23
Enrollment: 528
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was conducted to assess the safety and tolerability of the drug and to evaluate its efficacy in the treatment of osteoarthritis of the hip or knee in men and women.


Eligibility criteria: Inclusion Criteria:

* Patients with a clinical and radiographic diagnosis of osteoarthritis of the hip or knee
* Either prior NSAID or Acetaminophen users within the the ARA functional class I,II or III
* Patients required to demonstrate a "flare" of the signs and symptoms of OA following withdrawal of NSAID treatment
* Prior acetaminophen users also required to demonstrate greater than a defined minimum level of signs and symptoms of OA.

Exclusion Criteria:

* No history of concurrent arthritic disease
* uncontrolled hypertension or an active cardiac condition
* No history of hepatitis, neoplastic disease, stroke or transient ischemic attack within a specified duration.

Primary outcomes:
measure: Pain and physical function over 12-weeks as assessed by the WOMAC VA 3.0 pain subscale, WOMAC VA 3.0 physical function subscale, and Patient Global Assessment of Disease Status, as well as safety over 12-weeks as assessed by adverse experiences.
Secondary outcomes:
measure: Patient Global Assessment of Response to Therapy, Investigator Global Assessment of Disease Status, Stiffness, and Overall WOMAC scales as assessed over 12-weeks.
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Wiesenhutter CW, Boice JA, Ko A, Sheldon EA, Murphy FT, Wittmer BA, Aversano ML, Reicin AS; Protocol 071 Study Group. Evaluation of the comparative efficacy of etoricoxib and ibuprofen for treatment of patients with osteoarthritis: A randomized, double-blind, placebo-controlled trial. Mayo Clin Proc. 2005 Apr;80(4):470-9. doi: 10.4065/80.4.470.
citation: Laine L, Curtis SP, Cryer B, Kaur A, Cannon CP; MEDAL Steering Committee. Assessment of upper gastrointestinal safety of etoricoxib and diclofenac in patients with osteoarthritis and rheumatoid arthritis in the Multinational Etoricoxib and Diclofenac Arthritis Long-term (MEDAL) programme: a randomised comparison. Lancet. 2007 Feb 10;369(9560):465-73. doi: 10.1016/S0140-6736(07)60234-7.
Clinical trial NCT00806091: Functional Proteomics of Alveolar Macrophages
Official title: Functional Proteomics of Alveolar Macrophages
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD
Keywords: AM proteomes will be compared between smokers with and without COPD
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2008-12-10
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: smokers with and without COPD, general population

Brief summary: The purpose of this study is to obtain young white blood cells (monocytes) from the investigators donated blood for research into how these cells change into large, mature white blood cells (macrophages) and how smoking causes Chronic Obstructive Pulmonary Disease (COPD).

Detailed description: Our research goal is to identify new targets and strategies to help care for patients with Chronic Obstructive Pulmonary Disease (COPD). COPD is a chronic airway inflammatory disorder characterized by a progressive loss of pulmonary function. Mononuclear phagocytes are known to be critically involved in both repair/remodeling and destructive events in COPD. Although smoking is the chief environmental risk factor for COPD, the molecular details responsible for the genesis and progression of smoking-mediated COPD require further investigation. In searching for new knowledge and research strategies for this challenging topic, we have made substantial progress in mononuclear phagocyte proteomics and laid the groundwork for this translational research of COPD.

Eligibility criteria: Inclusion Criteria:

* COPD, smoker
* COPD, non smoker

Exclusion Criteria:

* none

Primary outcomes:
measure: to define AM's pathogenic pathways underlying the development of COPD
timeFrame: end of study
Secondary outcomes:
measure: to determine protein polymorphism(s) that impact genetic susceptibility to COPD
timeFrame: end of study
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: Haifeng Wu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01357291: Evaluating New Mexico's Recidivism Reduction Program
Official title: Evaluating New Mexico's Prison-Based Recidivism Reduction Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Behavior
Keywords: Behavior
Drug users
Inmates
Lead sponsor: Pepperdine University
Sponsor class: OTHER
Collaborators: name: University of California, Los Angeles
First posted: 2011-05-20
Enrollment: 159
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A a multi-site trial to measure the efficacy of the Recidivism Reduction Program, a prison based, twenty-one module reentry program operated by the New Mexico Department of Corrections.

Detailed description: The New Mexico Department of Corrections Recidivism Reduction Program (RRP) is designed to provide offenders with knowledge and skills that are transferable to the community setting and to address issues that offenders will invariably face upon release to the community. Transitional coping skills, offender expectations upon release, family issues, and dealing with authority figures are a few of the challenges facing offenders upon reintegration. The Recidivism Reduction Program is aimed at preparing offenders for the potential obstacles that they may encounter upon release to the community and providing them skills to overcome the challenges that they will face. The RRP curriculum focuses on belief systems, self-esteem, and rational thinking. The RRP is a twenty-one module clinician-led program (approximately 100 hours) delivered in a group setting within months of release. Outcomes focus on measures of transition readiness, successful transition into the community, and recidivism.

Eligibility criteria: Inclusion Criteria:

* Inmates who have six months prior to release
* Inmates housed at one of the four experimental prisons
* Inmates willing to participate in the Recidivism Reduction Program

Exclusion Criteria:

- Housed in security Level 4 or 5

Primary outcomes:
measure: Revocation rate
timeFrame: 12 months
Secondary outcomes:
measure: Days incarcerated
timeFrame: 12 months
measure: New arrests
timeFrame: 12 months
measure: Self esteem
timeFrame: 2 months
measure: Drug use self efficacy
timeFrame: 2 months
measure: Criminal thinking
timeFrame: 2 months
measure: Depression
timeFrame: 2 months
measure: Anxiety
timeFrame: 2 months
measure: Hostility
timeFrame: 2 months
Other outcomes:
Locations:
city: Grants
country: United States
facility: Western New Mexico Correctional Facility (WNMCF)
state: New Mexico
city: Los Lunas
country: United States
facility: Central New Mexico Correctional Facility (CNMCF)
state: New Mexico
city: Santa Fe
country: United States
facility: Penitentiary of New Mexico (PNM)
state: New Mexico
city: Springer
country: United States
facility: Springer Correctional Facility (SCF)
state: New Mexico
Study officials:
affiliation: Pepperdine University
name: Angela Hawken, PhD
role: PRINCIPAL_INVESTIGATOR
References: