louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06706336: Radon Asthma Intervention Trial
Official title: Radon Asthma Intervention Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Asthma
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2024-11-26
Enrollment: 180
Sex: ALL
Minimum age (years): 5
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine if radon mitigation can improve asthma

Detailed description: We will conduct a randomized, double-blind, sham controlled trial to investigate the efficacy of radon mitigation in the homes of susceptible individuals to provide evidence for health benefits by improving indoor air quality. The trial will include 180 children with asthma. We will install a standard radon specific mitigation system in the participant's home. Health outcomes will be followed over 48 weeks to determine the outcomes of the intervention versus inactive (sham) control.

Eligibility criteria: 1. Have physician-diagnosed asthma at least 1 year prior to the screening visit
2. Have evidence of uncontrolled disease as defined by at least one of the following:

Use of an asthma medication during the prior 12 months, report of asthma symptoms over the prior 12 months (wheezing/whistling in the chest)(3)

OR

One or more asthma-related hospitalization, emergency room visit

OR

Unscheduled clinic or urgent care facility visit resulting in a burst of systemic steroids (3 days or more of prednisone or equivalent; 1 or more doses of dexamethasone) in the previous 12 months

Exclusion Criteria

1. Not residing at the household for at least 5 days a week or family planning to move from the current home within the next twelve months, or homes with active radon mitigation systems (if home uses a HEPA filter air purifier, family must agree to disable the purifier for 28 days prior to randomization).
2. Lung disease, other than asthma, that requires daily medication (inflammatory diseases, chronic lung diseases aside from asthma, congenital cardiopulmonary conditions requiring medication or surgical treatment),
3. Homes with active HEPA filters will be excluded (even though the role of HEPA filters on radon and radon particles s is expected to be minimum and other exposures can be adjust for in the analysis)
4. Cardiovascular disease that requires daily medication, excluding hypertension
5. Taking a beta-blocker
6. Currently receiving unstable level of Immunotherapy (allergy shots)
7. Coordinator/PI judgment
8. Inability to perform lung function testing
9. Intake of abuse drugs or alcohol, have psychiatric disorders or severe mental disability that interferes with answering questions or following instructions.

Primary outcomes:
measure: Asthma symptoms
timeFrame: past 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Boston Children's Hospital
name: Wanda Phipatanakul
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03258736: Caudal Block Versus Ultrasound Guided Ilioinguinal/Iliohypogastric Block in Pediatric Patient
Official title: Comparison of Caudal Block and Ultrasound Guided Ilioinguinal/Iliohypogastric Block for Bilateral Inguinal Surgery in Pediatric Patient: A Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery
Keywords: pediatric, inguinal hernia, caudal, ilioinguinal/ilioihypogastric
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2017-08-23
Enrollment: 110
Sex: ALL
Minimum age (years): 1
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The caudal block is the most common technique for inguinal surgery. Increased use of ultrasound in regional analgesia techniques has been improved the practise of the peripheral nerve blocks. Ilioinguinal and iliohypogastric nerve blocks are possible to alternative methods to the central blocks. The aim of this study is to compare analgesic efficiency of caudal block and ultrasound guided Ilioinguinal and iliohypogastric nerve blocks for bilateral inguinal hernia in pediatric patients

Detailed description: In this prospective randomized study, pediatric patients between 1- 10 years old who were scheduled to bilateral inguinal hernia surgery wil be enrolled the study. The patients wil randomly assign to receive an ultrasound-guided Ilioinguinal/iliohypogastric block group or caudal block group Ilioinguinal/iliohypogastric block was performed with 2 mg/kg bupivacaine as 0.25 % and total volum wil be divided equally for each side, Caudal block wil performe with bupivacaine 2 mg/kg as 0.2%. Supplemental analgesia will consist of as requred intraoperative remifentanyl, for recovery unit rescue tramadol, as requred at home ibuprofen. Patients wil be evaluated in the recovery unit for analgesia with FLACC pain scale, analgesic requirement, complications and parental satisfaction. Parents will be also called for analgesia and satisfaction after discharge of the patients in first 24 hours. The evaluation will be performed by a researcher whom does not know which participants belong to the caudal or ilioinguinal/iliohypogastric nerve block group

Eligibility criteria: Inclusion Criteria:1- 10 year- old who were scheduled to bilateral inguinal hernia surgery -

Exclusion Criteria: Patients with neurological disoder, reoperation for inguinal hernia surgery, coagulation disorder

-

Primary outcomes:
measure: Analgesic requirements
timeFrame: up to 24 hours
Secondary outcomes:
measure: Postoperative complications
timeFrame: up to 24 hours
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Cerrahpasa Medical Faculty
state: Cerrahpasa
Study officials:
References:
Clinical trial NCT00234936: Quality of Life Study With Adalimumab in Rheumatoid Arthritis
Official title: Quality of Life Study With Adalimumab in Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Keywords: rheumatoid arthritis
adalimumab
quality of life
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2005-10-10
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the ability of adalimumab combined with methotrexate to improve the quality of life in patients with active RA.


Eligibility criteria: Inclusion Criteria:

* Subject is age 18 or older and in good health (Investigator discretion) with a recent stable medical history
* Subject has a diagnosis of rheumatoid arthritis as defined by the 1987 ACR criteria
* Subjects with treatment failure criteria to Mtx or Mtx + another DMARD

Exclusion Criteria:

* Subject considered by the investigator, for any reason, to be an unsuitable candidate for the study
* Female subject who is pregnant or breast-feeding or considering becoming pregnant
* Previous treatment with approved biological agents (etanercept, infliximab, anakinra) in the last 2 months

Primary outcomes:
measure: QOL
timeFrame: 12 months
Secondary outcomes:
measure: Patient reported outcomes
measure: Clinical response indicators
measure: Safety parameters
Other outcomes:
Locations:
Study officials:
affiliation: Abbott
name: Global Medical Information
role: STUDY_DIRECTOR
References:
Clinical trial NCT02226536: Vestibular Dysfunction and Glucose Metabolism
Official title: Fractionated and Restrictive Glucose Diet in Patients With Vestibular Dysfunction: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dysfunction of Vestibular System
Glucose Intolerance
Keywords: Posture
Vertigo
glucose metabolism
diet
scales
dinamic posturography
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2014-08-27
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Introduction: the global sugar consumption has increased in the past 50 years and their abusive intake is responsible for the insulin resistance and causes the metabolic syndrome - obesity, diabetes mellitus, hypertension and coronary heart disease. Objective: To evaluate the effect of scheduled diet without glucose as treatment of labyrinthine disorders associated with glucose-insulin index. Study Design: A prospective randomized controlled trial. Patients and Methods: A study conducted at the University of São Paulo with 51 patients divided into two groups: Diet Group (DG) that comprises subjects treated with fractionated diet with glucose restriction and control group (CG) where individuals were not counseled regarding diet. Patients underwent computerized dynamic posturography - sensory organization test (CDP - SOT) and Visual Analog Scale (VAS) in the first and thirtieth days of the study.

Detailed description: 51 patientes with dizziness and glucose intolerance diagnosed by the glucose tolerance test were selected.

The subjects were submited to CDP SOT conditions and a visual analogue scale to measure his self perception about dizziness.

Then, they were randomized in two groups: with and without fractioned diet without glucose during 30 days.

The CDP was repeated in order to verify a statistical difference of SOT condition 5 that reflects the individual hability to maintain the own posture with the vestibule solely and CS - that represents the final balance situation.

The VAS was repeated too in order to verify the self perception of the dizziness after diet.

Eligibility criteria: Inclusion Criteria:

* dizziness related to fasting or glucose intake
* alterations of glucose tolerance test

Exclusion Criteria:

* dizziness not related to vestibular problems
* ortopedical or neurological diseases
* diabetes mellitus

Primary outcomes:
measure: Assessment of equilibrium score through the computerized dynamic posturography (CDP) in 51 patients
timeFrame: 30 days
Secondary outcomes:
measure: Self perception of dizziness mesured by the visual analogue scale
timeFrame: 30 days
Other outcomes:
Locations:
Study officials:
affiliation: University of São Paulo, Brazil
name: Roseli SM Bittar, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04376736: Home Visits for Patients at Risk for Appointment No-shows
Official title: SNAP HOME: Smart No-show Analytics Paired With Home-based Outpatient Medical Engagement
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Utilization, Health Care
Engagement, Patient
No-Show Patients
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2020-05-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Unused clinic visits due to patient no-shows continue to plague American healthcare as a large source of waste and avoidable constraint on access. The average no-show rate across 105 studies was 23% though with wide variation (4% to 79%). No-show behavior has adverse effects on patients, providers, and healthcare organizations' operational and financial outcomes. Patients that miss clinic visits are more likely to need acute care and suffer poor health outcomes. There have been increasingly sophisticated efforts focused on predicting which patients are likely to no-show. This can allow for tactful over-booking and/or patient outreach. At Hopkins, investigators have implemented a novel machine learning based approach for identifying those patients at high-risk for no-show. Offering home visits for patients who are most likely to no-show is an appealing strategy to connect medical providers with patients who need care but are otherwise unlikely to receive it. Yet, it is unclear if this would be helpful to engage patients in their care, and encourage subsequent attendance, or if it would encourage future missed appointments, fostering a reliance on possible ongoing home visits. This study would link existing efforts with no-show prediction to home visits by internal medicine residents and evaluate its clinical impact. Patients at high-risk for no-show will be randomized into the control arm where patients will be called to remind patients of their visits. Those randomized into the intervention arm will be offered a one time home visit in lieu of their in-person visit to help understand barriers to in-person care and build rapport. Outcomes evaluated include future in-person show rates and healthcare cost/utilization


Eligibility criteria: Inclusion Criteria:

* One or more poorly controlled chronic medical illness
* More than one chronic illness, regardless of its level of control
* Acute illness

Exclusion Criteria:

* No documented medical illnesses (acute or chronic)
* Single well controlled chronic illness

Primary outcomes:
measure: Engagement
timeFrame: 1 year post enrollment
Secondary outcomes:
measure: Healthcare utilization as assessed by number of hospitalizations
timeFrame: 1 year post enrollment
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Outpatient Center
state: Maryland
Study officials:
References:
Clinical trial NCT03802136: Multiple Biomarkers in ICU Sepsis Patients
Official title: Prognostic Value of Early Oxidative Stress Biomarkers in Patients With Sepsis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sepsis, Severe
Sepsis
Septic Shock
AKI
Keywords: AKI
Sepsis
Biomarker
renal function
oxidative stress
Lead sponsor: Zhongnan Hospital
Sponsor class: OTHER
First posted: 2019-01-14
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients admitted to ICU of Zhongnan Hospital

Brief summary: Acute kidney injury (AKI) is a common condition among sepsis patients in the intensive care unit (ICU) and is associated with high morbidity and mortality. Oxidative stress biomarkers were investigated in panels and were reported to predict renal failure in sepsis patients. Some biomarkers would be able to identify who will recover and not recover better than serum creatinine. Thus, a combining oxidative stress biomarkers are needed to predict the occurrence or progression of AKI in critically ill patients.

Detailed description: Acute kidney injury (AKI) is a common condition among sepsis patients in the intensive care unit (ICU) and is associated with high morbidity and mortality. Oxidative stress biomarkers were investigated in panels and were reported to predict renal failure in sepsis patients. Research on AKI has focused on new damage biomarkers for early detection of AKI and worsening of renal function. Some biomarkers would be able to identify who will recover and not recover better than serum creatinine. Thus, a combining functional and damage markers as well as oxidative stress biomarkers are needed to predict the occurrence or progression of AKI in critically ill patients. Therefore, this prospective, observational study will be conducted in Mainland China

Eligibility criteria: Inclusion Criteria:

* sepsis patients in appropriate age

Exclusion Criteria:

* ever blood transfusion ever CPR（cardiopulmonary resuscitation)

Primary outcomes:
measure: presence of AKI
timeFrame: a week after admission to ICU
measure: Death of the patients
timeFrame: 2 weeks after admission to ICU
Secondary outcomes:
measure: Use serum creatinine to assess renal function of the patients
timeFrame: the 1 day when the patients admitted to ICU
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Zhongnan Hospital of Wuhan University
state: Hubei
Study officials:
affiliation: Zhongnan Hospital
name: zhiyong peng, professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05449236: A Reliability and Validity Study of Urdu Version of Western Ontario And MacMaster Osteoarthritis Index
Official title: A Reliability and Validity Study of Urdu Version of Western Ontario And MacMaster Osteoarthritis Index Among Pakistani Primary Knee Osteoarthritis Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Knee Osteoarthritis
Keywords: Western Ontario And MacMaster Osteoarthritis Index
Urdu Version
Reliability
Validity
Knee Osteoarthritis
Lequesne Index
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-07-08
Enrollment: 87
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pakistani population with primary knee Osteoarthritis will be included in the study.

Brief summary: The aim of the study is to translate and culturally adapt Western Ontario And MacMaster Osteoarthritis Index into Urdu language and to investigate its reliability and validity Pakistani population with primary knee osteoarthritis while assessing its correlation with Lequesne Index.

Detailed description: As per preceding commendation, Western Ontario And MacMaster Osteoarthritis Index will be translated into Urdu language from its English version and adapted culturally in Pakistan. Among primary knee osteoarthritis population, Western Ontario And MacMaster Osteoarthritis Index will be distributed among 87 patients recruited by convenience sampling technique under the pre-defined inclusion and exclusion criteria after signing consents forms. For testing inter-observer reliability and intra-observer reliability of Western Ontario And MacMaster Osteoarthritis Index and Lequesne Index will be administrated by two observers, on the same day, with a time interval of 2 hours between 1st and 2nd conduction. As for the 3rd conduction, it will be carried out after seven days by the first observer, for intra-observer assessment. Statistical Package of Social Sciences software version 24 will be used for the purpose of data entry and analysis. Internal consistency will be assessed by using an intra-class correlation coefficient. The Western Ontario And MacMaster Osteoarthritis Index will be evaluated for content validity, construct validity, criterion validity and responsiveness

Eligibility criteria: Inclusion Criteria:

* Male and Female patients
* Age above 40 years
* Participants with primary knee Osteoarthritis
* Patients willing to participate.

Exclusion Criteria:

* History or presence of ;
* Rheumatic diseases,severe articulation inflammation and cardiac disease.
* Participants with secondary knee Osteoarthritis.

Primary outcomes:
measure: Western Ontario And MacMaster Osteoarthritis Index
timeFrame: 1st day
measure: Lequesne Index
timeFrame: 1st day
Secondary outcomes:
Other outcomes:
Locations:
city: Faisalabad
country: Pakistan
facility: Ripah International University
state: Punjab
Study officials:
affiliation: Riphah International University
name: Muhammad Kashif
role: STUDY_CHAIR
References:
Clinical trial NCT01589536: Social Medical Progression of Coronary Heart Disease With Associated Psychosocial Comorbidity -Interval Rehabilitation.
Official title: Improvement of the Social Medical Progression of Coronary Heart Disease With Associated Psychosocial Comorbidity by the Use of Interval Rehabilitation.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiovascular Events
Keywords: psychocardiological
interval intervention
disability pension
risk profile
mental comorbidity
Lead sponsor: Clinic Roderbirken
Sponsor class: OTHER
First posted: 2012-05-02
Enrollment: 480
Sex: ALL
Minimum age (years): 18
Maximum age (years): 58
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to verfiy the hypothesis if a short intensive psychocardiological interval-intervention, combined with a structured follow up, decreases the rate of disability retirements caused by psychosocial co-morbidity of patients with coronary heart disease.

Detailed description: The purpose of the study is to verfiy the hypothesis if a short intensive psychocardiological interval intervention, combined with a structured follow up, decreases the rate of disability retirements caused by psychosocial co-morbidity of patients with coronary heart disease.

Eligibility criteria: Inclusion Criteria:

* Coronary heart disease
* Disease-related psychosocial morbidity
* not a disability retirements
* Insured with the German Rheinland pension (deutsche Rentenversicherung Rheinland)
* Sufficient language skills
* Age 18-58

Exclusion Criteria:

* Acute cardiac decompensation
* consuming the underlying disease
* psychotic disorder
* Acute suicidality
* pregnancy

Primary outcomes:
measure: Improvement of the social medical progression of coronary heart disease with associated psychosocial comorbidity by the use of interval rehabilitaion
timeFrame: 24 months after including study
Secondary outcomes:
measure: Improvement of the social medical progression of coronary heart disease with associated psychosocial comorbidity by the use of interval rehabilitaion
timeFrame: 24 months after including study
Other outcomes:
Locations:
city: Leichlingen
country: Germany
facility: Clinic Roderbirken
state: NRW
Study officials:
affiliation: Clinic Roderbirken
name: Wolfgang Mayer-Berger, MD
role: PRINCIPAL_INVESTIGATOR
References: