louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05872321: Assessment of the New Lateral Sinus Floor Elevation Technique Using Piezosurgery: A Clinical and Radiographic Retrospective Study
Official title: Assessment of the New Lateral Sinus Floor Elevation Technique Using Piezosurgery: A Clinical and Radiographic Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lateral Sinus Lift
Per-operation Complications
Lead sponsor: Saint-Joseph University
Sponsor class: OTHER
First posted: 2023-05-24
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All the patient needing lateral sinus lift procedure prior to implant placement.

Brief summary: All patients who received lateral sinus floor elevation using this new piezosurgery technique, were selected. The personal file of each patient was retrieved and the following data were taken: age, sex, smoking habits, occurrence of per-operative complications (mucosal perforation, hemorrhage) and post-operative infectious complications. Pre-operative CBCT of included patients were all performed using the same Newtom VGI radiographic machine and collected from the radiology unit at the Faculty of Dental Medicine at Saint Joseph University of Beirut. The measurement of the studied factors was performed on Newtom VGI viewer software, by two evaluators J.B. and A.M.


Eligibility criteria: Inclusion Criteria:

* Patients who received lateral sinus floor elevation using this new piezosurgery technique.

Exclusion Criteria:

* the usual exclsion criteria for external sinus lift procedure

Primary outcomes:
measure: Perioperative complication
timeFrame: During surgical procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: Saint Joseph University
Study officials:
References:
Clinical trial NCT05074121: NAC for Attenuation of COVID-19 Symptomatology
Official title: N-acetylcysteine for Attenuation of COVID Symptomatology
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Covid19
COVID-19 Pneumonia
COVID-19 Respiratory Infection
COVID-19 Lower Respiratory Infection
SARS-CoV2 Infection
SARS-CoV-2 Acute Respiratory Disease
SARS-Associated Coronavirus as Cause of Disease Classified Elsewhere
Oxidative Stress
Keywords: acetylcysteine
N-acetylcysteine
N-acetyl-cysteine
NAC
glutathione
Lead sponsor: Cambridge Health Alliance
Sponsor class: OTHER
Collaborators: name: The Thoracic Foundation
name: Alturix
First posted: 2021-10-12
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Double-Blinded Placebo-Controlled
Primary purpose: TREATMENT

Brief summary: The objective of this study is to determine whether oral NAC is effective at attenuating COVID-19 disease symptom severity and duration of symptoms.

Detailed description: STUDY DESIGN: Randomized double-blinded placebo-controlled trial

ELIGIBILITY

Inclusion criteria:

* age 18 years and older
* participants will need daily access to use of a smartphone for at least six weeks from time of enrollment
* Positive COVID-19 test within 10 days of date of enrollment
* not already hospitalized for treatment of COVID

Exclusion criteria:

* pregnant
* already hospitalized for treatment of COVID

PROTOCOL

* 50:50 randomization: half of participants will take NAC, half will take placebo
* Participants will take NAC/placebo following this outpatient protocol:
* 2400 mg x 1 PO then
* 1200 mg PO BID x 14 days
* Participants will complete an online symptom-tracker for six weeks (daily for three weeks, weekly for three weeks)

Eligibility criteria: Inclusion Criteria:

* positive COVID test \<= 7 days of enrollment

Exclusion Criteria:

* pregnant
* already hospitalized due to COVID

Primary outcomes:
measure: Symptom severity
timeFrame: 24 weeks starting the day after enrollment
measure: Symptom duration
timeFrame: 24 weeks starting the day after enrollment
Secondary outcomes:
measure: Need for higher level of care/hospitalization
timeFrame: 24 weeks starting the day after enrollment
Other outcomes:
Locations:
city: Everett
country: United States
facility: Cambridge Health Alliance
state: Massachusetts
Study officials:
References:
Clinical trial NCT03908021: The Salivary Microbiome in Children With Type 1 Diabetes Mellitus
Official title: The Salivary Microbiome in Children With Type 1 Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type1 Diabetes Mellitus
Keywords: diabetes mellitus
children
microbiome
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2019-04-09
Enrollment: 66
Sex: ALL
Minimum age (years): 5
Maximum age (years): 15
Standard ages: CHILD
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Saliva from 50 children ages 5 to 15 years old who had been diagnosed with type 1 diabetes mellitus and are followed at the Pediatric Endocrinology Clinic, Hadassah University Hospital Mt. Scopus and Ein Kerem, Jerusalem, Isreal, will be compared to 50 healthy children, preferably their siblings, matched in age and gender.

Brief summary: Aims: To profile the oral microbiome of children with type 1 diabetes mellitus, and to compare it to healthy children while taking into account other aspects of the oral environment.

Research: exploring the differences between oral microflora of children with type 1 diabetes mellitus and control healthy children using salivary microbiome. The investigators will furthermore intend to analyze the differences of salivary flow rate, pH, glucose, calcium, inorganic phosphate and urea between the two groups.

Detailed description: Saliva from 50 children ages 5 to 15 years old who had been diagnosed with type 1 diabetes mellitus and are followed at the Pediatric Endocrinology Clinic, Hadassah University Hospital Mt. Scopus and Ein Kerem, Jerusalem, Isreal, will be compared to 50 healthy children, preferably their siblings, matched in age and gender. Each patient or their legal guardian will sign an informed consent to participate in the study. The investigators will request a permission to access the medical records of the patients. Data will be collected from patient medical history. The investigators will measure salivary flow rate, pH and glucose, salivary Calcium, inorganic phosphate and urea and perform microbiome analysis and 16S rRNA gene-based analysis comparing children with diabetes to healthy children.

Eligibility criteria: Inclusion Criteria:

• Children with type 1 diabetes mellitus

Exclusion Criteria:

* Children Unable to give saliva sample
* Children On antibacterial medicaments

Primary outcomes:
measure: profile the oral bacteria related to caries and periodontal disease of children with type 1 diabetes mellitus
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
References:
Clinical trial NCT06587321: Remote Assessment of Signs and Symptoms in Palliative Care
Official title: The ReASSure-PC Study: A Feasibility Study of Remote Assessment of Signs and Symptoms in Palliative Care
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Palliative Care
Vital Signs
Remote Monitoring
Keywords: Remote monitoring
Lead sponsor: Our Lady's Hospice and Care Services
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have a diagnosis of a life-limiting condition, who are receiving care from the community palliative care team

Brief summary: Digital health interventions, including remote monitoring of patients, have been identified as a possible way to address current problems within the health service, including insufficient numbers of staff, and an increasing number of patients requiring services.

The aim of this study is to assess the feasibility of using remote monitoring for patients who are receiving palliative care and to see whether remote monitoring can improve care and outcomes for patients and their families.

Participants in this study will complete regular (daily, weekly, monthly) questionnaires online about how they are feeling. They will also be given equipment to measure their vital signs every day. The clinical team will have access to the results and be able to respond to any new problems as they arise. Patients and their carers will then complete a questionnaire at one month to assess satisfaction with the use of remote monitoring.


Eligibility criteria: Inclusion Criteria:

* Primary diagnosis of advanced cancer or another life-limiting condition
* Estimated prognosis greater than 3 months
* Referred for community-based specialist palliative care
* Living in own home (or home of family carer)
* Living with a family carer

Exclusion Criteria:

* Estimated prognosis less than 3 months or more than 12 months
* Cognitive impairment - unable to provide consent / complete assessments
* Non-English speaker
* Living in care home / nursing home / hospice / community hospital
* Not living with a family carer

Primary outcomes:
measure: Completion rates of assessments
timeFrame: At the end of 1 month
Secondary outcomes:
measure: Recruitment rate
timeFrame: 6 months
measure: Retention rate
timeFrame: 6 months
measure: Acceptability
timeFrame: 1 month
measure: Use of community palliative care resources
timeFrame: 6 months
measure: Use of GP / hospital resources
timeFrame: 6 months
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Our Lady's Hospice & Care Services
Study officials:
affiliation: Our Lady's Hospice & Care Services
name: Jenny Power
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00292721: Effects of Celecoxib After Percutaneous Coronary Intervention
Official title: Effects of Celecoxib on Restenosis After Percutaneous Coronary Intervention and Evolution of Atherosclerosis (COREA) Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Arteriosclerosis
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2006-02-16
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Several studies including ours have reported that celecoxib improves endothelium-dependent vasodilation and reduces inflammation and neointimal hyperplasia. Our hypothesis is that celecoxib may reduce the late luminal loss after coronary stent implantation (paclitaxel-eluting stent.


Eligibility criteria: Inclusion Criteria:

* Coronary artery disease with at least 1 de novo lesion greater than 50% stenosis on coronary angiography

Exclusion Criteria:

* Acute ST elevation MI
* Left main disease
* Contraindications to aspirin, clopidogrel or celecoxib
* Severe congestive heart failure
* Expected survival \< 2 years
* Hepatic dysfunction
* Currently taking NSAIDs or any COX-2 inhibitor
* Renal dysfunction
* Use of warfarin

Primary outcomes:
measure: Late luminal loss at 6 months
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Bon-Kwon Koo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chung JW, Yang HM, Park KW, Lee HY, Park JS, Kang HJ, Cho YS, Youn TJ, Koo BK, Chae IH, Choi DJ, Oh BH, Park YB, Kim HS. Long-term outcome of adjunctive celecoxib treatment after paclitaxel-eluting stent implantation for the complex coronary lesions: two-year clinical follow-up of COREA-TAXUS trial. Circ Cardiovasc Interv. 2010 Jun 1;3(3):243-8. doi: 10.1161/CIRCINTERVENTIONS.109.889881. Epub 2010 May 18.
citation: Koo BK, Kim YS, Park KW, Yang HM, Kwon DA, Chung JW, Hahn JY, Lee HY, Park JS, Kang HJ, Cho YS, Youn TJ, Chung WY, Chae IH, Choi DJ, Oh BH, Park YB, Kim HS. Effect of celecoxib on restenosis after coronary angioplasty with a Taxus stent (COREA-TAXUS trial): an open-label randomised controlled study. Lancet. 2007 Aug 18;370(9587):567-74. doi: 10.1016/S0140-6736(07)61295-1.
Clinical trial NCT01211821: Effect of BMS-914392 on Pharmacokinetics of Metoprolol
Official title: Effect of BMS-914392 on the Pharmacokinetics of Metoprolol and on Heart Rate After Co-administration of BMS-914392 and Metoprolol in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Atrial Fibrillation
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
Collaborators: name: PRA Health Sciences
First posted: 2010-09-30
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of the study is to assess the effects of BMS-914392 administration on the pharmacokinetics of a single-dose of metoprolol in healthy subjects.

Detailed description: Protocol designed to evaluate the potential for a drug-drug-interaction

Eligibility criteria: Inclusion Criteria:

* Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations.
* Subjects genotyped as Intermediate, Extensive or Ultra-rapid CYP2D6 metabolizers
* Women of childbearing potential (WOCBP) and men must be using an acceptable method of contraception to avoid pregnancy

Exclusion Criteria:

* Any significant acute or chronic medical illness.
* Current or recent (within 3 months of study drug administration) gastrointestinal disease.
* Current or history of neurological diseases or psychiatric disorders, cardiovascular diseases, and bronchospastic diseases.
* CYP2D6 poor metabolizers based on genotype

Primary outcomes:
measure: Pharmacokinetics of single dose of metoprolol derived from serial measurements of metoprolol plasma concentrations
timeFrame: Pre-dose and 0.5 Hr, 1 Hr, 1.5 Hr, 2 Hr, 3 Hr, 4 Hr, 6 Hr, 8 Hr, 12 Hr, 24 Hr, and 36 Hr after dosing of metoprolol alone or in combination with BMS-914392
Secondary outcomes:
measure: The effect of multiple doses of BMS-914392 on PR, QRS, RR, and QTc intervals derived from serial electrocardiograms (ECGs)
timeFrame: Pre-dose and 0.5 Hr, 1 Hr, 1.5 Hr, 2 Hr, 3 Hr, 4 Hr , 6 Hr, 8 Hr, 12 Hr, 24 Hr after dosing with metoprolol alone or in combination with BMS-914392
measure: Number of subjects with adverse events as a measure of safety and tolerability of BMS-914392
timeFrame: Daily
Other outcomes:
Locations:
city: Lenexa
country: United States
facility: Pra International
state: Kansas
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT00086021: Acupuncture for the Treatment of Chronic Daily Headaches
Official title: Acupuncture for the Treatment of Chronic Daily Headaches
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Headache Disorders
Keywords: Headache
Acupuncture
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
First posted: 2004-06-22
Enrollment: 74
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: The purpose of this study is to determine whether acupuncture can reduce pain in long-term headache sufferers.

Detailed description: Acupuncture has been shown to reduce the frequency and severity of some types of headaches, but the efficacy of acupuncture for chronic daily headaches has not been studied. The long-term goals of this study are to reduce the symptoms that are associated with recurrent headaches and to collect data that can be used for future acupuncture studies.

Participants in this study will be randomly assigned to receive 8 weeks of either standard care or ten acupuncture treatments in addition to medical care. Self-report questionnaires will be used to assess headaches and daily pain severity.

Eligibility criteria: Inclusion Criteria:

* Ability to communicate in English
* Presence of headache 15 or more days in the past month

Exclusion Criteria:

* Known intracranial mass
* Recent surgery to the head and neck region

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Harvard Medical School
state: Massachusetts
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
Study officials:
References:
Clinical trial NCT03796221: Parenting Intervention for Pediatric Obesity
Official title: Integrating Parenting Interventions Into Pediatric Obesity Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Obesity
Parenting
Keywords: Childhood obesity
Parenting intervention
Video intervention
Healthcare delivery
Lead sponsor: Nemours Children's Health System
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2019-01-08
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see if educational videos about how to help children develop healthy behaviors, paired with treatment in a pediatric obesity clinic, can increase caregiver confidence and improve child behaviors and weight. Caregivers of children between the ages of 4 and 11 years old who are new patients to a pediatric obesity clinic will be invited to take part in the study. All families will receive the standard treatment provided in the pediatric obesity clinic. Half of the caregivers will be assigned to also watch a few educational videos every month for 3 months in between clinic visits.


Eligibility criteria: Inclusion Criteria:

* Legal guardian of a new patient to the Nemours pediatric obesity clinic
* Child with body mass index (BMI) greater than the 95th percentile for age and sex
* Child 4-11 years of age

Exclusion Criteria:

* Not proficient in English or Spanish
* Not able to access the internet on any type of device
* Child has a genetic syndrome or primary endocrine disorder associated with obesity
* Child is taking a medication known to impact weight

Primary outcomes:
measure: Change in child weight status
timeFrame: 6 months
measure: Change in child weight status
timeFrame: 6 months
measure: Change in caregiver confidence managing child lifestyle behaviors
timeFrame: 6 months
measure: Change in child lifestyle behaviors
timeFrame: 6 months
Secondary outcomes:
measure: Discussion of parenting topics during visits to the pediatric obesity clinic
timeFrame: 1 month, 2 months, 3 months, 6 months
measure: Change in child weight status
timeFrame: 3 months
measure: Change in child weight status
timeFrame: 3 months
measure: Change in caregiver confidence managing child lifestyle behaviors
timeFrame: 3 months
measure: Change in child lifestyle behaviors
timeFrame: 3 months
Other outcomes:
Locations:
city: Wilmington
country: United States
facility: Nemours Alfred I. duPont Hospital for Children
state: Delaware
Study officials:
affiliation: Nemours Children's Health System
name: Thao-Ly T Phan, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04303221: Effects of the Anchor System in the Postural Stability
Official title: Effects of the Anchor System in the Postural Stability of Women Submitted to the Treatment of Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Balance; Distorted
Keywords: Breast cancer
Lymphedema
Postural balance
Falls
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2020-03-11
Enrollment: 80
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluate the effect of a balance rehabilitation program associated or not with the use of the anchor system, on the postural control of women undergoing breast cancer treatment.

Detailed description: The aim of this study is to compare the effects of an exercise program associated or not with a non-rigid instrument, called the anchor system, on the postural control of women undergoing breast cancer treatment. For this purpose, 80 women submitted to breast cancer treatment will be invited to participate, divided into four homogeneous groups, determined by the sample calculation: women submitted to breast cancer treatment in the age group of 35 to 59 years (young adult) with lymphedema (GAJL), women in the same age group without lymphedema (GAJ), women in the age group 60 to 80 years (elderly) with lymphedema (GIL), and women in the same age group without lymphedema (GI). Cognitive status will be assessed by the Mini Mental State Examination. To assess the subsystems responsible for maintaining balance, the Balance Evaluation Systems Test (BESTest) will be used, presented in order to guide clinical intervention, in addition to the Falls Efficacy Scale -International (FES-I). The distribution of plantar pressure and balance will be assessed using baropodometry. For data analysis, a normality test and data distribution will be performed, in addition to a statistical test consistent with the appropriate intra and intergroup comparisons, with a significance level of 5%.

Eligibility criteria: Inclusion Criteria:

* Women undergoing treatment for breast cancer, in the 35 to 59 age group with lymphedema, women in the same age group without lymphedema, women in the 60 to 80 age group with lymphedema, and women in the same age group without lymphedema.

Exclusion Criteria:

* Women diagnosed with rheumatic-orthopedic diseases; with complaints of balance; with injury to the peripheral nervous system of upper or lower limbs.

Primary outcomes:
measure: Functional balance
timeFrame: 5 minutes
measure: Accidental falls
timeFrame: 5 minutes
measure: Plantar pressure distribution
timeFrame: 10 minuntes
Secondary outcomes:
Other outcomes:
Locations:
city: Ribeirão Preto
country: Brazil
facility: Medical School of Ribeirão Preto
state: São Paulo
Study officials:
affiliation: University of Sao Paulo - Ribeirao Preto - Brazil
name: Elaine Guirro, PhD
role: PRINCIPAL_INVESTIGATOR
References: