louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01667107: A Pharmacokinetic Analysis of Posaconazole in Lung Transplant Recipients (MK-5592-105)
Official title: A Pharmacokinetic Analysis of Posaconazole in the Plasma and Alveolar Compartment of Lung Transplant Recipients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Fungal Infection
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2012-08-17
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This single site study will examine plasma and alveolar compartment (AC) levels of posaconazole in cystic fibrosis (CF) and non-cystic fibrosis (non-CF) lung transplant recipients receiving routine post-operative anti-fungal prophylaxis. Invasive fungal infection rates will be assessed following transplantation.


Eligibility criteria: Inclusion Criteria:

* Scheduled to undergo lung transplantation
* Able to take oral/nasogastric medication
* Females of childbearing potential, males, and the sexual partners of males must use an effective method of birth control during this study and for 6 weeks after completing the study.

Exclusion Criteria:

* Severe liver disease
* Current use of cytochrome P-450 (CYP)-3A4 inhibitors including terfenadine, astemizole, cisapride, pimozide, halofantrine or quinidine within 7 days before transplant
* Treatment with posaconazole within 14 days before transplant
* Breastfeeding

Primary outcomes:
measure: Time to Reach 90% of the Steady State Serum Concentration of Posaconazole
timeFrame: Four hours after the first daily dose on Days 1-12 and every Monday and Thursday on Days 13-43
measure: Concentration of Posaconazole in Bronchoalveolar Lavage (BAL) and Serum
timeFrame: Up to Day 42
Secondary outcomes:
measure: Percentage of Participants Who Develop Invasive Fungal Infection
timeFrame: Up to Day 84
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03913507: Efficacy of a New Sweat Collection Support: Impact on Neonatal Screening and Early Treatment of Cystic Fibrosis
Official title: Efficacy of a New Sweat Collection Support: Impact on Neonatal Screening and Early Treatment of Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Keywords: Cystic Fibrosis Children
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2019-04-12
Enrollment: 57
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: In nearly 25% of children under 3 months, the sweat test produces a quantity of sweat that does not meet international recommendations and is insufficient to allow reliable and reproducible biological analyzes in the sweat collected. In children between 3 and 12 months, this rate is about 10% when it should not exceed 5%. Insufficient amount of sweat prevents confirmation or reversal of the early diagnosis of cystic fibrosis and early treatment before irreversible complications of the disease.

In this trial, a new support of sweat collection (Macroduct® Advanced Model 3710 Sweat Collection System, Wescor) will be tested with the goal to increase the amount of sweat collected during the sweat test, in comparison with the clinical routine method.


Eligibility criteria: Inclusion Criteria:

* Subject aged of 2 days to 12 months
* Indication of a sweat test prescribed by a clinician in a context of neonatal screening
* Clinically stable
* Well hydrated
* Not under treatment with mineralocorticoids

Exclusion Criteria:

* Subjects weighing less than 2 kg
* Subjects less than 48 hours old
* Presence of an acute infectious condition
* Presence of mineralocorticoid treatment

Primary outcomes:
measure: chloride concentration
timeFrame: day 1
Secondary outcomes:
measure: sweat
timeFrame: day 1
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques Universitaires St Luc
Study officials:
affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
name: Teresinha Leal
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06154707: Clinical Controlled Study on the Efficacy of Denosumab in Treating Osteoporosis in the Domestic Population and Its Impact on Sarcopenia-related Outcomes
Official title: Clinical Controlled Study on the Efficacy of Denosumab in Treating Osteoporosis in the Domestic Population and Its Impact on Sarcopenia-related Outcomes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Sarcopenia
Osteoporosis
Denosumab
Lead sponsor: Wuhan Union Hospital, China
Sponsor class: OTHER
First posted: 2023-12-04
Enrollment: 86
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: Through the method of a clinical randomized controlled trial, patients meeting the study criteria are randomly assigned to either the Denosumab treatment group or a placebo group. After a treatment period of 12 months, the differences in osteoporosis and sarcopenia-related baseline assessment changes between the two groups are compared. This is to explore the effect of Denosumab in treating osteoporosis and its impact on sarcopenia. The goal is to evaluate the efficacy of Denosumab in treating osteoporosis in the domestic population and its related impact on sarcopenia, with the aim of providing an effective treatment option for the domestic population suffering from 'osteoporosis-sarcopenia syndrome.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of postmenopausal/senile osteoporosis after examination and assessment.
* Clinical diagnosis of postmenopausal/senile osteoporosis combined with sarcopenia after examination and assessment.
* Have not previously taken any other anti-osteoporosis drugs.

Exclusion Criteria:

* Clinical diagnosis of pathological fractures.
* Have participated in another clinical trial within the past 3 months or have taken other anti-osteoporosis drugs within the past 6 months.
* Severe chronic metabolic diseases or serious organ failure.

Primary outcomes:
measure: Osteoporosis-related Primary Outcome
timeFrame: 1 year
measure: Sarcopenia-related Primary Outcome
timeFrame: 1 year
Secondary outcomes:
measure: Quality of life and fall risk
timeFrame: 1 year
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Union Hospital Tongji Medical College Huazhong University of Science and Technology
state: Hubei
Study officials:
References:
Clinical trial NCT01125007: Capacity of Biofilm Removal and Gingival Abrasion After Utilization Medium and Soft Toothbrushes
Official title: Biofilm Capacity Removal and Gingival Abrasion After Utilization Medium and Soft Toothbrushes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Biofilm Removal
Gingival Abrasion
Keywords: Dental plaque
Gingival abrasion
toothbrushing
Lead sponsor: Franciscan University Center
Sponsor class: OTHER
First posted: 2010-05-18
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: This study compared the removal of dental biofilm between soft and medium toothbrushes. The patients refrained from performing mechanical or chemical plaque control for 96 hours to allow dental biofilm accumulation on the tooth surfaces. After the period of dental biofilm formation, the quadrants were randomized and the participants brushed different quadrants with soft and medium toothbrushes, with or without dentifrice. The plaque indices were analyzed by a blinded examiner before and after toothbrushing. The 2Tone was used for plaque disclosure and analysis was performed by the Quigley-Hein index modified by Turesky et al. (1970).


Eligibility criteria: Inclusion Criteria:

* The study was conducted on 25 participants selected among undergraduate dental students of UNIFRA (Santa Maria, Rio Grande do Sul, Brazil)
* Males and Females
* All systemically healthy
* Aged 18 to 30 years (mean age 21.4 ± 3.9 years) with at least 20 present teeth

Exclusion Criteria:

* The exclusion criteria comprised presence of sites with attachment loss ≥ 2mm
* Orthodontic appliances
* Prostheses
* Dental implants
* Aabrasions, restorations and/or carious lesions on the cervical region

Primary outcomes:
measure: Gingival abrasion
timeFrame: Presence of gingival abrasion
Secondary outcomes:
Other outcomes:
Locations:
city: Santa Maria
country: Brazil
facility: Franciscan Universtity center
state: RS
Study officials:
References:
Clinical trial NCT05415007: GOLD: Brief Intervention to Reduce Anxiety and Promote Resilience in Families of Youth With Cancer
Official title: Brief Intervention to Reduce Anxiety and Promote Resilience in Caregivers of Youth With Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Keywords: Any types of cancer
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2022-06-10
Enrollment: 40
Sex: ALL
Minimum age (years): 8
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to examine a psychotherapeutic and psycho-educational intervention offered in virtual settings to caregivers of youth with cancer. Human subjects must be used because they are the object of the intervention.

Detailed description: PRIMARY OBJECTIVE(S)- To examine the feasibility and accessibility of a brief intervention for caregivers of youth with newly-diagnosed cancer as a preliminary, data-generating step toward applying for a larger NCI R34 grant evaluating the efficacy of the program in a randomized controlled trial.

SECONDARY OBJECTIVE(S)- We hope to learn whether a psycho-educational, psychotherapeutic intervention offered in a virtual setting to caregivers of children diagnosed with cancer is feasible, is acceptable, and can prevent, minimize, or improve symptoms of psychological distress (including symptoms of anxiety, depression, and post-traumatic stress disorder). We also hope to further our understanding of family stress and expand the idea for a need of mental health services in pediatric oncology. We aim to further understand intervention strategies for domains of family stress, reducing levels of caregiver anxiety, and promoting resilience for caregivers. This is important because these symptoms can affect the quality of life of caregivers and affect their ability to adhere to their children's treatments.

Eligibility criteria: Inclusion and Exclusion Criteria: Parents

Inclusion

* Child (0-17yrs) with recent (\<12 mo) cancer diagnosis
* Fluent in English
* Consent to research

Exclusion:

* Lack of proficiency in written and spoken English
* Parent is under age 18
* Active Suicidal Ideation
* Child with cancer does not provide assent

Inclusion and Exclusion Criteria: Children

Inclusion:

* Recent (\<12 mo) cancer diagnosis in child
* 8-17 Years old
* Provides assent to participate in the study

Exclusion:

* Cannot read English
* Parent is not enrolled in the study

Anyone who is not a caregiver of children who have been diagnosed with cancer within the past 12 months will be excluded.

Primary outcomes:
measure: Number of caregivers who enroll in the GOLD program
timeFrame: 1 month
Secondary outcomes:
measure: Acceptability of the GOLD Program for caregivers
timeFrame: 1 month
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: Stanford Cancer Institute
state: California
Study officials:
affiliation: Stanford University
name: Victoria E. Cosgrove, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04352907: Accuracy of CGM in the ICU, Compared to Standard of Care
Official title: Accuracy of Dexcom G6 Continuous Glucose Sensor in the Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diabetes
Keywords: insulin infusion
continuous glucose sensor
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: DexCom, Inc.
First posted: 2020-04-20
Enrollment: 20
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: Subjects in the Intensive Care Unit

Brief summary: To determine the performance of the Dexcom CGM device in comparison to arterial glucose samples.

Detailed description: The performance of the Dexcom continuous glucose sensor will be compared with the current standard of care which is arterial glucose samples analyzed on a glucose meter. Subjects will be ICU patients receiving intravenous insulin infusions.

Eligibility criteria: Inclusion Criteria:

* minimum age 18 years
* anticipated to be on an insulin infusion for 3-7 consecutive days
* 10 of these subjects will be on vasopressors who will be receiving large volume fluid resuscitation

Exclusion Criteria:

* subjects not on insulin infusion

Primary outcomes:
measure: Continous Glucose Sensor values (CGM)
timeFrame: 3 to 7 consecutive days
Secondary outcomes:
measure: Vasopressor Use
timeFrame: 3 to 7 consecutive days
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
Study officials:
References:
Clinical trial NCT06434207: Extracellular Vesicle Micro RNA Profiling in Congenital Heart Disease: Fetal-Maternal Regulation in Neonatal Thrombosis
Official title: Extracellular Vesicle Micro RNA Profiling in Congenital Heart Disease: Fetal-Maternal Regulation in Neonatal Thrombosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Congenital Heart Disease
Single-ventricle
Thrombosis
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2024-05-30
Enrollment: 10
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All neonates with a diagnosis of severe Congenital Heart Disease undergoing surgery at Boston Children's Hospital in the first week of life.

Brief summary: Newborns with congenital heart disease (CHD) are at increased risk of developing postpartum and postoperative blood clots after cardiac surgery. The molecular mechanisms that are responsible for the clotting profile predisposing children to blood clots in the early stages of life are currently not well described.

The goal of this proposal is to prospectively collect plasma samples from ten (10) neonates with antenatal diagnosis of severe congenital heart disease (CHD) to better understand mechanisms responsible for abnormal clotting in the perioperative period.


Eligibility criteria: Inclusion Criteria:

* All neonates with a diagnosis of severe Congenital Heart Disease undergoing surgery at Boston Children's Hospital in the first week of life

Exclusion Criteria:

* None

Primary outcomes:
measure: Characterization of microRNA in whole blood samples from neonates
timeFrame: 2 days
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
References:
Clinical trial NCT04675307: Multimodal, Task-Aware Movement Assessment and Control: Clinic to the Home
Official title: Multimodal, Task-Aware Movement Assessment and Control: Clinic to the Home
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Frailty
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: Boston University
First posted: 2020-12-19
Enrollment: 50
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: Study population will consist of frail adults and frail older adults. Frailty is defined as a state of increased vulnerability and reduced ability to recover after a stressful event, leading to adverse health outcomes.

Brief summary: The investigators seek to construct a novel, multimodal, distributed system that facilitates a new paradigm of home-based medical surveillance and treatment for frail older adults centered on timely diagnosis of movement system impairments and personalized intervention. Measurements from a heterogeneous set of complementary sensors will be combined with clinically-informed and data-learned dynamic models of human motion to enable real-time activity recognition (e.g., sitting, standing, walking) and movement assessments (e.g., speed, repetition, quality). As the study progresses, the system will be integrated with wearable assistive technology to provide "smart", activity-specific assistance of movement deficits or the activation of caregivers if a decline in function is detected. Finally, the investigators will test the combined assessment and intervention system in the clinic and the home, identifying challenges and solutions for the scaling up to unconstrained real-world settings.


Eligibility criteria: Inclusion Criteria:

* Age \>= 18 years
* Capacity to consent
* Community dwelling
* Ability to follow 3-step commands
* Lives within 15 miles of Boston

Exclusion Criteria:

* Undomiciled
* Active substance use disorder
* Active psychosis
* Domestic violence or neglect
* Inability to communicate with investigators
* Other comorbidities that prevent full participation in the research

Primary outcomes:
measure: Video and inertial motion unit capture
timeFrame: 1 recording episode, approximately 3 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
References:
Clinical trial NCT01763307: A Study to Examine the Effect of Reconval K1 Cream to Prevent Skin Toxicity From EGFRI
Official title: A Phase II Randomized, Double Blind, Placebo Study to Evaluate the Efficacy of Vitamin K1 Cream Treatment Compared to Placebo for the Prevention of Papulo-pustular Rash in Metastatic Colorectal Patients Receiving First Line EGFRI Treatment.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Rash Due to Epidermal Growth Factor Receptor Inhibitors
Keywords: EGFRI
COLON CANCER
SKIN TOXICITY
RECONVAL K1 cream
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2013-01-08
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Vitamin K1 cream may prevent papulopustular rash induced by EGFRI given to metastatic colorectal cancer patients.

This study will prospectively accrue metastatic colorectal patients receiving EGFRI and treat with reconval cream half face versus placebo cream half face to study whether Vitamin k1 cream can prevent the typical skin eruption caused by EGFRI.


Eligibility criteria: Inclusion Criteria:

* metastatic colon cancer patients
* male or female
* age\> 18
* treated EGFRI

Exclusion Criteria:

* prior treatment with EGFRI

Primary outcomes:
measure: Potential reduction in skin toxicity by Vitamin K1 cream in metastatic colorectal patients treated with EGFRI
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hadassah Medcial Organization
name: Sharon Merims, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02960607: High-dose Icotinib Treatment Beyond Progression in EGFR Mutant NSCLC
Official title: A Phase II Study of High-dose Icotinib in Previously Treated Non-small Cell Lung Cancer Patients With Epidermal Growth Factor Receptor Mutation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Carcinoma, Non-Small-Cell Lung
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
First posted: 2016-11-09
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate whether high-dose icotinib treatment beyond disease progression is beneficial for NSCLC patients who have EGFR mutation and who have responded to EGFR TKI.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed stage IIIB/IV NSCLC
* Investigator confirmed progression according RECIST 1.1 during previous icotinib treatment
* Patients whose tumors:

  * are EGFR mutation-positive or
  * T790M mutation-negative
* Performance status: WHO 0-2
* Measurable disease according to RECIST 1.1

  * at least one measureable lesion .if only one measureable lesion, the biological nature must be confirmed by cytology or histology
  * a single diameter of lesion could be measured by at least one of the following methods: Chest or abdominal computed tomography(CT)or magnetic resonance imaging(MRI),conventional methods of diameter at least 20mm diameter spiral CT OR at least 10mm
* ANC ≥ 1.5\*109/L, Platelets ≥ 75\*109/L, Hgb≥ 9g/dL, Alanine amino transferase ≤ 2 × Upper limit of normal (ULN), Alkaline phosphatase ≤ 2.5 × ULN (\< 5 × ULN if liver metastases), Serum Creatinine ≤ 1.5 × ULN
* Women of childbearing age must have a pregnancy test 7 days before treatment and the result were negative ,men of childbearing age: surgical sterilization or treatment during and after the end of three months to take contraceptive measures
* Patient must be able to comply with the protocol

Exclusion Criteria:

* Patient with symptomatic central nervous system metastases
* Patient has known active hepatitis B or C, or HIV infection
* Pregnant or breastfeeding.
* Patient with uncontrolled undercurrent illness or circumstances that could limit compliance with the study

Primary outcomes:
measure: Progression Free survival
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese Academy of Medical Sciences
Study officials:
References: