louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05067738: Same Day Discharge for Wedge Resection
Official title: The Development of a Novel Same Day Discharge Program After Pulmonary Resection: A Safety and Feasibility Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery
Minor
Lung Cancer
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2021-10-05
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: 2 phases
Primary purpose: OTHER

Brief summary: Monitoring carefully selected participants to determine if participants can be safely discharged the same day of pulmonary resection

Detailed description: Determination of the feasibility of implementing a same day discharge program after minor pulmonary surgery. This will be determined by evaluating the percentage of participants who have chest tubes removed successfully, as well as evaluating the percentage of participants who would be classified as discharged on the day of surgery. The investigators will also be evaluating morbidity associated with this protocol by capturing rates of pleural reintervention.

Eligibility criteria: Inclusion Criteria:

Patients aged 18 years of age and older who are scheduled to undergo an elective minimally invasive wedge resection of their lung.

Exclusion Criteria:

1. Pulmonary function tests demonstrating forced expiratory volume in 1 second (FEV1) \<50% predicted, FEV1 \<1.5L and/or diffusion lung capacity of carbon monoxide (DLCO) \<50% predicted.
2. Patient receives an intraoperative pleurodesis.
3. Conversion to open thoracotomy or mini thoracotomy intraoperatively.
4. Active pregnancy.
5. Thoracic Revised Cardiac Risk Index Score (ThRCRI)8 \>2.
6. Underlying cognitive disorder resulting in inability to complete activities of daily living.

Primary outcomes:
measure: Rate of successful same day discharge
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
Study officials:
affiliation: Western University
name: Rahul Nayak
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01271738: Evaluating and Comparing Two Surgical Methods for Treatment of Early Stage Breast Cancer
Official title: Measuring the Effect of Additional Tumor Cavity Margins Excision at the Time of Breast Conserving Surgery for Stage 0, I, II, and III Breast Cancer Patients on Re-excision Rate, Cosmetic Results and Total Costs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Neoplasms
Breast Cancer
Breast Tumors
Cancer of Breast
Cancer of the Breast
Human Mammary Carcinoma
Neoplasms, Breast
Keywords: Breast Cancer
Tumors or cancer of the human breast
Breast Tumors
Cancer of Breast
Cancer of the Breast
Human Mammary Carcinoma
Neoplasms, Breast
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2011-01-07
Enrollment: 79
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this study is to compare two different types of breast surgery. In the first type, the doctor removes only the tumor. In the second type, the doctor removes the tumor and some of the tissue around the tumor called margins. The amount of breast tissue removed is similar. The removal of the tumor only has up to 40% chance of reoperation because the tumor is too close to the margin. The primary goal of this study is to see if the additional margins can decrease the need to return to the operating room. Both types of surgery are well accepted, and participating in the study would not give you a better chance to cure the cancer. At present, most breast surgeons remove the tumor without the additional margins. For all patients who have this operation, there is a high incidence of return to the operating room for margins re-excision: as many as 40% as patients can have a re-operation.

At present, we do not know if taking the additional margins prevents the cancer from returning in the breast or not. If the cancer comes back in your breast, this is a recurrence and your breast will have to be removed (mastectomy).


Eligibility criteria: Inclusion Criteria:

* Female Patients with the diagnosis of Stage 0, I, II and III breast cancer diagnosed/treated at the AVON Foundation Comprehensive Breast Center (AFCBC) of Grady Memorial Hospital
* Age: no limit

Exclusion Criteria:

* Stage IV breast cancers

Primary outcomes:
measure: Comparing 2 surgical methods for treatment of early stage breast cancer
timeFrame: Post operative evaluation will be at 30 days, then at 4-7 months and last at 12-15 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Winship Cancer Institute
state: Georgia
Study officials:
affiliation: EmoryUniversity Winship Cancer Institute
name: Monica Rizzo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06647238: Pharmacist Interventions in Cholesterol Management of Very High Risk Patients
Official title: Second Time's the Charm: Evaluation of Pharmacist Interventions in Lipid Management for Secondary Prevention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperlipidemia
Coronary Artery Disease
Keywords: Pharmacist intervention
Hyperlipidemia treatment
secondary prevention of cardiovascular disease
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2024-10-17
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Control group will not directly interact with investigators. Will perform retrospective chart review only.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The primary objective of this research project is to compare the effect of pharmacist interventions versus usual care in the implementation of guideline directed lipid lowering therapies for secondary prevention.

Detailed description: Studies have shown prevention of cardiovascular adverse events is directly proportional to percent reduction in low-density lipoprotein (LDL). This evidence explains why LDL targets for secondary prevention have continued to be lowered. Cholesterol guidelines have been updated recently and encourage the use of multiple lipid lowering therapies, in addition to statins, for secondary prevention. However, these novel agents can be expensive and difficult to acquire, making prescribing challenging for providers.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of coronary artery disease
* low-density lipoprotein (LDL) \> 55
* Primary Care Physician at 1 of 6 identified clinics

Exclusion Criteria:

* Patients who are no longer an active patient of one of the internal medicine practices
* Patients whose cholesterol is managed by another practice
* Women of childbearing age/potential
* Patients residing in hospice/Long Term Care facilities
* End-stage liver disease

Primary outcomes:
measure: Number of Subjects who meet low-density lipoprotein (LDL) at goal (<55)
timeFrame: Month 5
Secondary outcomes:
measure: Percent change in low-density lipoprotein (LDL)
timeFrame: Baseline to end of study period up to Month 5
measure: Number of Medication related problems identified and solved
timeFrame: Baseline to end of study period up to Month 5
measure: Number of Medications initiated or titrated
timeFrame: Baseline to end of study period up to Month 5
measure: Number of patients provided assistance with medication access
timeFrame: Baseline to end of study period up to Month 5
measure: Number of Subjects with Prevalence of elevated Lipoprotein(a)
timeFrame: Baseline to end of study period up to Month 5
Other outcomes:
Locations:
city: Concord
country: United States
facility: Atrium Health Cabarrus
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Kayla Marvin, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02676843: Tau PET Imaging With 18F-AV-1451 in Subjects With MAPT Mutations
Official title: Tau PET Imaging With 18F-AV-1451 in Subjects With MAPT Mutations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Frontotemporal Lobar Degeneration (FTLD)
Frontotemporal Dementia (FTD)
Tauopathies
Keywords: FTLD
FTD
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2016-02-08
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The study will investigate the ability of a new PET tracer, 18F-AV-1451, to detect depositions of a protein, called tau, in the brains of people with a mutation in the tau gene that causes deposition of the protein, and in people without the mutation. Up to three 18F-AV-1451 scans will be performed (one per year) on control subjects without MAPT mutations, presymptomatic mutation carriers, and symptomatic mutation carriers.

Detailed description: Approximately 40% of cases of Frontotemporal lobar Degeneration (FTLD) are also associated with abnormal deposition of tau protein. The purpose of this study is to image MAPT mutation carriers and their non-carrier relatives in order to study the use of this tracer as a biomarker in Frontotemporal Lobar Degeneration with tau deposition (FTLD-tau).

Eligibility criteria: Inclusion Criteria:

* Members of families with established MAPT mutations, who either have the capacity to consent to participate in the protocol, or else have designated a surrogate/proxy to consent to participate in this study

Exclusion Criteria:

* Unwillingness to participate
* Usage of medication which significantly prolongs QT interval
* Pregnancy or plans for pregnancy within 90 days after participating in study

Primary outcomes:
measure: SUVR of 18F-AV-1451
timeFrame: Baseline, 12-month follow up
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Morton A. Kreitchman PET Center
state: New York
Study officials:
affiliation: Columbia University
name: Edward Huey, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01505543: Proprioceptive Postural Control and Chronic Obstructive Pulmonary Disease (COPD)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Proprioceptive Postural Control
Chronic Obstructive Pulmonary Disease
Lead sponsor: KU Leuven
Sponsor class: OTHER
Collaborators: name: Universitaire Ziekenhuizen KU Leuven
First posted: 2012-01-06
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: patients from the University Hospital Leuven - Respiratory Disvision

Brief summary: Proprioceptive weighting changes may explain differences in postural control performance. In addition, the respiratory movement has a disturbing effect on postural balance. Postural balance seems to be impaired in individuals with respiratory disorders. Increased risk of falling is reported in individuals with chronic obstructive pulmonary disease. Besides the essential role of respiration, the diaphragm may also play an important role in the control of the trunk and postural balance.

The aim of the study is to clarify whether proprioceptive postural control is impaired in individuals with chronic obstructive pulmonary disease.


Eligibility criteria: Inclusion Criteria individuals with chronic obstructive pulmonary disease:

* Age: 40-80 years old
* Spirometry (post-bronchodilator) based diagnosis of COPD (GOLD criteria)
* Willingness to sign the informed consent

Inclusion Criteria healthy controls:

* Age: 40-80 years old
* No COPD (spirometry based: FEV1/FVC ≥ 0.7 and FEV1 \> 80%)
* Willingness to sign the informed consent

Exclusion Criteria:

* History of major trauma and/or major orthopedic surgery of the spine, the pelvis or the lower quadrant
* One of the following conditions: Parkinson, multiple sclerosis, stroke, history of vestibular disorder
* Respiratory disorder other than COPD
* α1-antitrypsin deficiency
* Known history of significant inflammatory disease other than COPD
* COPD exacerbation within 4 weeks prior to study
* Lung surgery
* Recent diagnosis of cancer
* Therapy with oral corticosteroids in the last 6 weeks
* Significant cardiovascular comorbidity

Primary outcomes:
measure: Proprioceptive postural control
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Katholieke Universiteit Leuven
state: Vlaams-Brabant
Study officials:
affiliation: KU Leuven
name: Simon Brumagne, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: KU Leuven
name: Thierry Troosters, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: KU Leuven
name: Wim Janssens, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: KU Leuven
name: Marc Decramer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Janssens L, Brumagne S, Polspoel K, Troosters T, McConnell A. The effect of inspiratory muscles fatigue on postural control in people with and without recurrent low back pain. Spine (Phila Pa 1976). 2010 May 1;35(10):1088-94. doi: 10.1097/BRS.0b013e3181bee5c3.
Clinical trial NCT01025843: Safety and Tolerability of MK-5478 in Participants With Hypertension (5478-001)
Official title: A Single Dose Study to Evaluate the Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of MK5478 in Subjects and in Patients With Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hypertension
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-12-04
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a two part introductory clinical trial with MK-5478. Part I will evaluate the safety, tolerability and pharmacokinetics and pharmacodynamics of MK-5478 in young, healthy males. Part II will evaluate the safety, tolerability and pharmacodynamic effects of MK-5478 in participants with hypertension. The primary hypothesis is that single oral doses of MK-5478 are sufficiently safe and well tolerated.


Eligibility criteria: Inclusion Criteria:

Part I:

* Is a male between 18 to 50 years of age
* Is in good health
* Is a non-smoker

Part II:

* Is male of non-child bearing potential between 18 and 50 years of age
* Has hypertension (high blood pressure)

Exclusion Criteria:

Part I and Part II:

* Has a history of stroke, seizures or major neurological disorder
* Has a history of cancer
* Has a history of any cardiovascular disease
* Is unable to refrain from the use of any prescription or non-prescription drugs
* Consumes excessive amounts of alcohol or caffeine
* Has had major surgery, donated blood or participated in another investigational study in the past 4 weeks

Primary outcomes:
measure: Number of Participants With One or More Adverse Events (AEs)
timeFrame: Up to 14 days after administration of last dose of study drug (up to Day 52)
measure: Number of Participants Who Discontinued Treatment Due to an AE
timeFrame: Up to 24 hours after administration of study drug
Secondary outcomes:
measure: Area Under the Plasma Concentration Versus Time Curve (AUC 0-infinity) of MK-5478 and Candesartan
timeFrame: Pre-dose and up to 48 hours postdose
measure: Change From Baseline in Aortic Augmentation Index (AIx) of MK-5478 and Candesartan
timeFrame: Baseline and 1 to 3 hours postdose
measure: Maximum Plasma Concentration (Cmax) of MK-5478 and Candesartan
timeFrame: Pre-dose and up to 48 hours postdose
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT00189943: Study on Safety, Tolerability and Immunogenicity of an MVA Vaccine Administered to Healthy Subjects
Official title: Phase I Study on Safety, Tolerability and Immunogenicity of the MVA-BN Vaccine Administered to Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Smallpox
Lead sponsor: Bavarian Nordic
Sponsor class: INDUSTRY
First posted: 2005-09-19
Enrollment: 90
Sex: MALE
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to collect information on the safety, tolerability and immunogenicity of an investigational smallpox vaccine at different doses and using different routes of administration in vaccinia-naive and vaccinated healthy volunteers


Eligibility criteria: Inclusion Criteria:

* Healthy male subjects, aged 20 - 55 years
* Signed informed consent

Exclusion Criteria:

* Prior vaccination against smallpox (study part I only)
* Abnormalities suspicious of any underlying disease, detected at routine tests prior to study inclusion.
* Any immune modifying therapy within 4 weeks prior to entry
* Participation in any other investigating drug trial
* Known allergy to a component which may be part of the vaccine
* Allergic reaction or any other severe adverse effects experienced after previous smallpox vaccination (study Part II only)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Moenchengladbach
country: Germany
facility: PharmPlanNet Contract Research GmbH
Study officials:
affiliation: PharmPlanNet Cantract Research GmbH
name: Karl M Eckl, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03918343: Lipopolysaccharide Metabolism and Identification of Potential Biomarkers Predictive of Graft-versus-host Disease After Allogeneic Stem Cell Transplantation
Official title: Study of Lipopolysaccharide Metabolism for Identification of New Biomarkers Predictive of Graft-versus-host Disease After Allogeneic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hematologic Diseases
Stem Cell Transplantation
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2019-04-17
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This study is designed to assess the hypothesis that the lipopolysaccharide (LPS) activity index can be quantified early after transplantation, as well as the the PhosphoLipid Transfer Protein (PLTP) activity and these both biological variables are independent variables for predicting the risk of severe Graft versus Host Disease (GVHD).


Eligibility criteria: Inclusion Criteria:

* Hematologic malignancy in complete remission
* Patients eligible for allogeneic hematopoietic cell transplantation from a related or unrelated donor and after myeloablative or non-myeloablative conditioning.
* Regular follow-up in the center

Exclusion Criteria:

* Treatment with a statin in progress
* Umbilical cord blood transplantation
* Hemoglobin level less than or equal to 8g / dl
* Known chronic inflammatory bowel disease or gastroenteritis at the time of inclusion.
* Chronic enteropathy with Clostridium Difficile

Primary outcomes:
measure: Area under the ROC curve for PLTP in the occurrence of GVHD
timeFrame: 3 months
measure: Area under the ROC curve for LPS in the occurrence of GVHD
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: Centre Hospitalier Universitaire de Besançon
city: Nancy
country: France
facility: Centre Hospitalier Universitaire de Nancy
Study officials:
affiliation: CHU Besançon
name: Etienne Daguindau, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06106243: Evaluation of Digital 3D Printed Temporary Removable Partial Denture.
Official title: Oral Health-Related Quality of Life and Retention in Digitally Versus Conventionally Fabricated Flexible Removable Partial Dentures in Maxillary Class III Modification 1 Patients: A Cross-over Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Partial-edentulism
Temporary Partial Denture
3D Printing
Oral Health Related Quality of Life
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-10-30
Enrollment: 13
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study aims to compare oral health-related quality of life and retention between digitally- fabricated temporary flexible RDPs and conventionally-fabricated temporary flexible RDPs.


Eligibility criteria: Inclusion Criteria:

* Maxillary Class III, modification I partially edentulous patients that enables measuring the retention values intraorally without denture rotation.
* Fully dentulous or partially edentulous opposing mandibular arch.
* Patients that require temporary partial dentures for aesthetic reasons or as an interim denture during mouth rehabilitation treatment or after implant placement.
* Age range (30-55 years).
* Cooperative patients that are willing to attend all follow-up periods.
* Patients with healthy attached mucosa of appropriate thickness free from any inflammation.
* Patients with healthy abutments and healthy periodontium and no more than grade I mobility.

Exclusion Criteria:

* Patients with Parkinson's disease
* Patients with xerostomia.
* Patients with a history of allergy to dentures made of resins.
* Patients with pathological changes of residual ridges as recurrent or persistent ulcers, osteomyelitis and infections.
* Patients with large irregular bony exostosis.
* Patients with medical or psychological conditions as physical disability or mental retardation that hinder cooperation in the follow up visits and answering the questionnaires.

Primary outcomes:
measure: Oral health-related quality of life.
timeFrame: Baseline and 6 months
measure: Retention of a removable partial denture
timeFrame: Baseline and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Faculty of dentistry , Cairo university
Study officials:
References: