louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01345617: A Study of Sweat Testing Using a Quantitative Patch
Official title: A Study of Sweat Testing Using a Quantitative Patch
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystic Fibrosis
Lead sponsor: Polychrome Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2011-05-02
Enrollment: 170
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pediatric pulmonology clinic

Brief summary: The primary aim of the study is to determine if the CF Quantum Sweat Test provides sweat chloride results that are equivalent to the results from traditional sweat testing. The secondary aim of the study is to assess the quantity not sufficient rate of the CF Quantum Sweat Test compared to traditional sweat testing.

Detailed description: All 50 states and the District of Columbia are performing newborn screening for cystic fibrosis (CF). Infants who have a positive newborn screen require follow-up with a sweat test. Gibson-Cooke Quantitative Pilocarpine Iontophoresis (GCQPIT) requires collecting sweat in microbore tubing or on gauze/filter paper and analyzing sweat using a chloridometer. This test has many difficulties including specimens that are quantity not sufficient (QNS), many steps of pipetting solutions in the laboratory, and the need for a chloridometer to analyze sweat chloride concentration. The only manufacturer of a chloridometer has ceased production of this instrument. The CF Quantum® Sweat Test System (CFQT) overcomes all of the difficulties of GCQPIT. This pilot study will determine if the CFQT provides results that are equivalent to GCQPIT.

Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of cystic fibrosis
* patients who require a sweat test

Exclusion Criteria:

* Infants less than 48 hours of age
* Patient is receiving oxygen by open delivery
* collection site has diffuse inflammation or rash

Primary outcomes:
measure: sweat chloride value
timeFrame: once, at enrollment (baseline)
Secondary outcomes:
measure: QNS rate
timeFrame: once, at enrollment (baseline)
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Madison
country: United States
facility: American Family Children's Hospital
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Michael J Rock, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01058317: Propranolol Administration in Pediatric Patients With Recurrent Respiratory Papillomatosis
Official title: Propranolol Administration in Pediatric Patients With Recurrent Respiratory Papillomatosis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Recurrent Respiratory Papillomatosis
Keywords: respiratory, papilloma, pediatric, juvenile
Lead sponsor: Massachusetts Eye and Ear Infirmary
Sponsor class: OTHER
First posted: 2010-01-28
Enrollment: 0
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Juvenile onset recurrent respiratory papillomatosis (JORRP) is a rare, difficult to treat, benign tumor of the pediatric airway. Current therapy is mainly surgical, but in a significant portion of patients adjuvant therapy is required to control the disease process. Although multiple adjuvant medical therapies have been tried, success has been limited. We have seen some success in a limited amount of patients using orally administered propranolol. Our goal is to enroll a larger cohort of patients to determine the effectiveness of propranolol as an adjuvant therapy for JORRP.


Eligibility criteria: Inclusion Criteria:

* 1. Biopsy proven with appropriate Human Papilloma Virus typing Recurrent Respiratory Papilloma
* 2. Child under age 10
* 3. Informed consent and where appropriate informed assent
* 4. Children who have undergone at least 4 documented surgical interventions in the past year.

Exclusion Criteria:

* Parental or child refusal to participate
* Heart failure
* Atrio-ventricular heart block
* Cardiac anomalies
* Low resting heart rate
* Low resting blood pressure
* Wolff-Parkinson White Syndrome
* Unexplained syncope
* Asthma or Reactive airway disease
* Renal or liver failure
* Expected long fasting periods, \>12 hours
* Diabetes Mellitus
* Hypersensitivity to propranolol

Primary outcomes:
measure: Decreased number of surgeries
timeFrame: 3 months
Secondary outcomes:
measure: Improved voice quality
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Massachusetts Eye and Ear Infirmary
name: Christopher Hartnick, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00793117: The Effect of Packing in Post Operative Management of FESS
Official title: The Evaluation of Effect of Pva Sponge in Prevention of Complications in Fess
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Epistaxis
Nasal Obstruction
Pain
Keywords: chronic sinusitis
FESS
packing
Lead sponsor: Tehran University of Medical Sciences
Sponsor class: OTHER
First posted: 2008-11-19
Enrollment: 66
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Chronic sinusitis is a very common problem. The functional endoscopic sinus surgery is a prevalent option to treat this disease.During usage of different techniques of surgery, the need for packing after surgery is debatable problem. So to solve this problem this research has been designed.

Detailed description: Chronic sinusitis is a very common problem. The functional endoscopic sinus surgery is a prevalent option to treat this disease.During usage of different techniques of surgery, the need for packing after surgery is debatable problem.

Someone claimed packing is unnecessary and other one propose different material to packing after surgery. So to solve this problem this research has been designed.

Eligibility criteria: Inclusion Criteria:

* All patients with chronic sinusitis who candid of fess

Exclusion Criteria:

* Systemic disease
* Corticosteroid usage counterindication
* Immune suppresive usage
* Choncha bollusa resection-

Primary outcomes:
measure: complication
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Imam Khomaimee hospital
Study officials:
affiliation: Tehran University of Medical Sciences
name: babak saedi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04687917: The Substance Abuse Treatment to HIV Care II (SAT2HIV-II) Project
Official title: The Substance Abuse Treatment to HIV Care II (SAT2HIV-II) Project
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Substance Use
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2020-12-29
Enrollment: 428
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster-randomized trial
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: An experiment to test the effectiveness of providing monetary bonuses to staff for achieving pre-defined performance targets regarding the implementation of a motivational interviewing-based brief intervention for substance use.

Detailed description: A cluster-randomized type 3 hybrid trial with HIV service organizations across the United States. The primary aims is to test the effectiveness of an innovative pay-for-performance (P4P) strategy for improving the implementation of a motivational interviewing-based brief intervention for substance use.

Eligibility criteria: Inclusion Criteria:

* Inclusion criteria for staff participants:

  * 18+ years of age

Inclusion criteria for client participants:

* 18+ years of age
* Diagnosed with HIV

Exclusion Criteria:

* Exclusion criteria for staff participants:

  * None

Exclusion criteria for client participants:

\* None

Primary outcomes:
measure: Staff-level Implementation Consistency
timeFrame: Assessed at the end of month 12
measure: Staff-level Implementation Quality
timeFrame: Assessed at the end of month 12
Secondary outcomes:
measure: Staff-level Average Change (Follow-up Minus Baseline) in Their Client Participant's Days Using Primary Substance
timeFrame: Assessed at 4-weeks from the baseline assessment
measure: Staff-level Average Change (Follow-up Minus Baseline) in Their Client Participant's Generalized Anxiety Disorder 7-item (GAD-7) Score
timeFrame: Assessed at 4-weeks from the baseline assessment
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
affiliation: Ohio State University
name: Bryan R Garner, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05396417: How Well do the Current Cesarean Deliveries Adhere to the Published ERAS Guidelines?
Official title: Early Recovery After Surgery for Patients Undergoing Cesarean Delivery; Adherence to the Institutional Guideline
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cesarean Section Complications
Lead sponsor: Women's Hospital HUS
Sponsor class: OTHER
First posted: 2022-05-31
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women undergoing cesarean delivery at the University of Helsinki central hospital/Women's hospital

Brief summary: Local guidelines for the postoperative care of women who have undergone cesarean delivery at the HUS/Women's hospital are based recommendations by the ERAS society. This study will take a prospective sample of 500 parturients who have gone through a cesarean delivery and their care will be verified against the local check-list for cesarean delivery.

Detailed description: The study will produce a snapshot of the current state of treatment in the third largest delivery hospital in Europe. The study will include cesarean deliveries in all urgency categories.

The data will be collected prospectively by enrolling parturients in consecutive order from the study start date. The data will be collected in the form of a paper check list that is to be filled up by the nursing staff and doctors who are taking care of the parturient through her stay at the hospital.

Eligibility criteria: Inclusion Criteria:

* Eligible for ERAS protocol cesarean delivery
* Cesarean delivery for any indication
* Any anesthesia method
* Any urgency category

Exclusion Criteria:

* Age under 18 years

Primary outcomes:
measure: Level of adherence to the ERAS guidelines after elective or emergency cesarean delivery
timeFrame: 3 days post surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: HUS/Women's hospital dept of obstetrics
Study officials:
References:
Clinical trial NCT06622317: Abdominal Aortic Junction Tourniquet (AAJT-S) for Non-compressible Torso Haemorrhage
Official title: Abdominal Aortic Junction Tourniquet (AAJT-S) for Non-compressible Torso Haemorrhage: a Prospective Observational Pilot Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Exanguination
NCTH
Polytrauma
Keywords: NCTH
aortic occlusion
exanguniation
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2024-10-02
Enrollment: 10
Sex: ALL
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: all patients meeting the eligibility criteria that are being transported to the rescucitation room of the Medical University of Graz

Brief summary: This study seeks to evaluate the feasibility of a Abdominal Aortic Balloon Occlusion of the Aorta (AAJT-S) in exanguinating trauma patients with non-compressible truncal haemorrhage in the emergency room and the pre-hospital setting.

Detailed description: The study is designed as a prospective observational study to accomapany the impementation of this device in clinical routine. However, the device has already been used in the emergency room and AAJT-S application is no study specific intervention.

Eligibility criteria: Inclusion Criteria:

* aged, or believed to be aged, 18 years or above,
* confirmed or suspected life-threatening lower body trauma (i.e. signs of inadequate perfusion of tissues, tachycardia, hypotension, suspected blood loss)
* is thought to benefit from trauma resuscitation with AAJT-S or REBOA zone III

Exclusion Criteria:

* suspected additional bleeding source proximal to the umbilicus, or
* known or suspected pregnancy at presentation, or
* known abdominal aortic aneurysm

Primary outcomes:
measure: effective placement of the device
timeFrame: 1 hour
Secondary outcomes:
measure: 30-day mortality
timeFrame: 30 days
measure: Complications
timeFrame: 90 days
measure: Heart rate
timeFrame: 1 hour
measure: Base excess
timeFrame: 1hour
measure: Blood pressure (systolic and diastolic)
timeFrame: 1 hour
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz
state: Styria
Study officials:
References:
Clinical trial NCT00863317: Trial of Montelukast for Treatment of Acute Bronchiolitis
Official title: A Randomized, Double Blind, Placebo Controlled Trial of Daily Montelukast for the Treatment of Viral Bronchiolitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bronchiolitis
Keywords: Bronchiolitis
montelukast
leukotriene inhibitor
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
First posted: 2009-03-18
Enrollment: 141
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary rationale for this study is to evaluate the effect of once daily montelukast on duration of acute illness in infants with first-time bronchiolitis.


Eligibility criteria: Inclusion Criteria:

* Male or female infants aged 3 to 12 months of age
* Diagnosis by emergency physician of bronchiolitis

Exclusion Criteria:

* Any previous episode, as determined by a physician, of wheezing, bronchiolitis or asthma
* Any history of previous bronchodilator use prior to this illness
* Treatment with corticosteroids in the 14 days prior to the current illness
* Immunosuppression
* Immunodeficiency
* Caregiver does not speak English
* Diagnosis by the treating ED physician of croup
* Diagnosis by the treating ED physician of pneumonia
* Caregiver does not have access to a telephone

Primary outcomes:
measure: Duration of Cough
timeFrame: up to 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Children's Hospital of Wisconsin
state: Wisconsin
Study officials:
affiliation: Medical College of Wisconsin
name: Marc Gorelick, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03668717: Survivorship and Outcomes of Robotic-Arm Assisted Medial Unicompartmental Knee Arthroplasty
Official title: Survivorship and Outcomes of Robotic-Arm Assisted Medial Unicompartmental Knee Arthroplasty
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Osteoarthritis
Keywords: osteoarthritis
medial
unicompartmental
Lead sponsor: St. Helena Hospital Coon Joint Replacement Institute
Sponsor class: OTHER
Collaborators: name: Stryker Orthopaedics
First posted: 2018-09-13
Enrollment: 133
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients over 21 years of age who required a primary robotic-arm assisted medial unicompartmental arthroplasty.

Brief summary: The purpose of the study is to determine the survivorship of robotic-arm assisted MCK medial onlay Unicompartmental knee arthroplasty implants at two, five and tem year follow up.

Detailed description: The purpose of the study is to determine the survivorship of robotic-arm assisted MCK medial onlay unicompartmental knee arthroplasty implants at two, five, and ten year follow up. Study participants will also be asked about their level of satisfaction with their knee function following their robotic-arm assisted Unicompartmental Arthroplasty.

Eligibility criteria: Inclusion Criteria:

* All patients over 21 years of age who underwent primary robotic-arm assisted unicompartmental arthroplasty and received a medial MCK onlay implant and are at least 24 months post-operative.
* Patient has signed an IRB approved Informed Consent Form or with IRB approved waiver of written consent, patient has verbally consented to study participations.
* Patient willing to comply with follow up.

Exclusion Criteria:

* Patient will be excluded from participation in the study if they are cognitively unable to answer questions related to their index procedure and health related quality of life forms.
* Patient had active infection
* Medial MCK onlay implants were implanted without bone cement
* Patients did not have sufficient bone stock to allow for insertion and fixation of components
* Patient did not have sufficient soft tissue integrity to allow for stability
* Patient had a neurological or muscular deformity that did not allow for control of the knee.

Primary outcomes:
measure: % of patients with revisions
timeFrame: 10 year after surgery
Secondary outcomes:
measure: % of patients with revisions
timeFrame: 2 years after surgery
Other outcomes:
measure: % of patients with revisions
timeFrame: 5 years after surgery
Locations:
city: Saint Helena
country: United States
facility: St. Helena Hospital Coon Joint Replacement Institute
state: California
Study officials:
affiliation: St. Helena Hospital Coon Joint Replacement Institute
name: Thomas Coon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01469117: Feeding Trial in Pediatric Patients
Official title: Enteral Formula Tolerance In Pediatric Patients With Developmental Disabilities
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Developmental Disabilities
Keywords: Developmental disabilities
Enteral Nutrition
Tube feeding
Nutrition support
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2011-11-10
Enrollment: 16
Sex: ALL
Minimum age (years): 1
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric patients with developmental disabilities

Brief summary: This is a single center, prospective, non-randomized, uncontrolled, observational study of the use of an enteral nutrition product in pediatric patients with developmental disabilities.

Detailed description: This prospective observational study seeks to assess ability to achieve enteral feeding goals with a new tube feeding product in pediatric patients with developmental disabilities.

Eligibility criteria: Inclusion Criteria:

* Child aged 1-13 years old with development disabilities
* Currently tolerating enteral feeding
* Requiring nutritional management to meet 50-90th% weight for age on the Kennedy Kreiger Growth Charts
* Requires enteral tube feeding for at least 14 days.

Exclusion Criteria:

* Unable to access gastrointestinal tract for feeding via tube
* Other condition which contraindicates tube feeding

Primary outcomes:
measure: Time to feeding goal achievement
timeFrame: up to 14 days
Secondary outcomes:
measure: Gastrointestinal measures assessment
timeFrame: up to 21 days
measure: Percentage of nutrition goal met
timeFrame: daily up to 21 days
measure: Serum biochemical markers assessment
timeFrame: baseline and completion of study
measure: Assessment of frequency and nature of adverse events
timeFrame: daily up to 21 days
Other outcomes:
Locations:
city: Bethany
country: United States
facility: The Children's Center
state: Oklahoma
Study officials:
affiliation: The Children's Center
name: Darin Brannan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05596617: Safety and Efficacy of Medications COVID-19
Official title: Safety and Efficacy of Drugs Given Off-label for COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Severe Covid-19
Keywords: Covid-19
Adverse events
Organ dysfunction
Mortality
Lead sponsor: Hospital San Carlos, Madrid
Sponsor class: OTHER
First posted: 2022-10-27
Enrollment: 335
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: quasi-experimental
Primary purpose: TREATMENT

Brief summary: We performed a quasi-experimental open-label pragmatic study alternating standard of care (SOC) and oral bedtime melatonin (OBM) at different high doses over 4 consecutive time periods enrolling all consecutive RT-PCR SARS-CoV-2 severe Covid-19 admissions.

Detailed description: The 4 successive study time periods spanned from March 2020 to April 2021 and included: 1) standard of care (SOC) (C1), 2) SOC + oral bedtime melatonin (OBM) (T1), 3) SOC (C2), and 4) SOC + OBM (T2). During T1, 3 consecutive subgroups received 50 mg, 100 mg and 200 mg OBM. During T2, 100 mg OBM was given. Melatonin was administered from ICU admission to hospital discharge or death.

The main objectives were occurrence of predefined severe adverse events (SAEs), Sequential Organ Failure Assessment (SOFA) scores and day-30 (D30) and 90 (D90) mortality. Study subjects were followed for modified Rankin scale (mRS) at 30 days after the last OBM dose or hospital discharge.

Eligibility criteria: Inclusion Criteria:

* Positive RT-PCR for SARS-CoV-2

Exclusion Criteria:

* Anticipated death within 48 hours or paliative care

Primary outcomes:
measure: Severe adverse events
timeFrame: From date of inclusion until date of hospital discharge or death
measure: Organ dysfunction
timeFrame: On days 1, 4, 7, 14 and 30 since first dose of melatonin
measure: Mortality
timeFrame: On days 30 and 90 since first dose of melatonin
Secondary outcomes:
measure: Length of stay
timeFrame: Date of inclusion until date of ICU and hospital discharge or death
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
Study officials:
affiliation: Universidad Complutense Madrid
name: Jesus Fernandez-Tresguerres, MD.PhD
role: STUDY_CHAIR
References: