louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03477838: Pharmacist-driven CGM Use in the Uninsured Population
Official title: A Pharmacist-driven Continuous Glucose Monitoring Program for Advanced Diabetes Management in an Uninsured Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: continuous glucose monitoring
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2018-03-26
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a pilot study. The purpose is to (1) provide access to continuous glucose monitoring (CGM) to patients (purchased through a grant) and (2) systematically record and analyze the results of the glucose monitoring by the clinical pharmacists at the clinic.


Eligibility criteria: Inclusion Criteria:

1. adult 18 years of age or older
2. diagnosis of Type 1 or Type 2 diabetes
3. A1c greater than 8%
4. prescribed basal insulin plus either prandial insulin or a glucagon-like peptide-1 (GLP-1) receptor agonist

Exclusion Criteria:

1. pregnant or breast-feeding
2. on dialysis
3. not appropriate for CGM use based on clinical judgment by the investigators
4. patients with limited English proficiency

Primary outcomes:
measure: Change in A1c
timeFrame: Baseline to week 12
Secondary outcomes:
measure: Medication Changes
timeFrame: Baseline to week 12
measure: Glycemic Variability
timeFrame: Baseline to week 12
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Evan Sisson, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00481338: Prevalence,Natural History,Prognosis Factor,QualityofLife,Health Care Consumption and Social Consequences of Symptomatic Knee and Hip Osteoarthritis in France
Official title: Knee and Hip OsteoArthritis Long Term Assessment. Prevalence, Natural History, Prognosis Factor, Quality of Life, Health Care Consumption and Social Consequences of Symptomatic Knee and Hip Osteoarthritis in France
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hip Osteoarthritis
Knee Osteoarthritis
Keywords: Cohort
Quality of life
Health resource use
Disability
Prognosis
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2007-06-01
Enrollment: 878
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The aim of the project is to assemble and to follow on a 10-year period a nationwide representative sample of lower limb OA patients.

General objectives: To document the natural history and to identify predictive factors of the evolution and consequences of hip and knee OA in terms of pain, functional disability, structural damage, quality of life, autonomy, medical and health care use and cost of disease.


Eligibility criteria: Inclusion Criteria:

* male and female aged between 40 and 75 years
* symptomatic hip or knee, uni or bilateral OA with clinical diagnosis confirmed by a medical physician and satisfying ACR classification criteria
* Representative of prevalent cases in France at the cohort set-up time

Exclusion Criteria:

* presence of hip or knee joint replacement surgery
* comorbidities severe enough to affect quality of life significantly or likely to induce a high health care consumption independently of OA
* an history of osteotomy
* Patello-femoral osteoarthritis without tibio-femoral osteoarthritis
* Other joint diseases of the target joints
* adult under legal protection or not able to consent

Primary outcomes:
measure: Quality of life, patient reported outcome measures
timeFrame: every year, up to 10 years
Secondary outcomes:
measure: health care consumption
timeFrame: every year, up to 10 years
Other outcomes:
Locations:
city: Amiens
country: France
facility: Patrice Fardellone
city: Brest
country: France
facility: CHU de la Cavale Blanche
city: Nancy
country: France
facility: CHU Nancy, hopital brabois
city: Nice
country: France
facility: CHU l'Archet
city: Paris
country: France
facility: Hôpital de la Pitié-Salpêtrière
city: Toulouse
country: France
facility: CHU Rangueil
Study officials:
affiliation: CHU Nancy (promoteur)
name: Francis Guillemin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00255138: Efficacy of Atomoxetine Therapy Versus Placebo for Cognitive Late Effects
Official title: Efficacy of Atomoxetine Therapy Versus Placebo For Ameliorating Cognitive Late Effects Among Survivors of Childhood Cancers
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Cancer
Cognitive Late Effects
Keywords: Cancer
Cognitive Late Effects
Stimulants
Atomoxetine
Attention
Children
Lead sponsor: Temple University
Sponsor class: OTHER
Collaborators: name: Eli Lilly and Company
First posted: 2005-11-17
Enrollment: 0
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the effectiveness and safety of atomoxetine in enhancing attention and concentration among childhood survivors of cancer.

Detailed description: In previous years, it had often been assumed that cognitive and behavioral declines in children who survived cancer therapy were largely a function of the prophylactic therapies (e.g., radiation, chemotherapy) that these children had received. Regardless of the etiologies of these specific late effects, the data regarding the long-term outcome of these children are strikingly consistent. Generally, the studies to date suggest significant impairments in attention and concentration that result in marked declines in academic performance and social and behavior difficulties.

Despite the clear evidence of problems with attention and concentration, as well as associated fucntional impairments (e.g., poor academic achievement and poor peer relationships), there have been few clinical trials designed to manage the cogntive late effects and neurological toxicities associated with radiation therapy and chemotherapy for children and adolescents who have survived cancer.

Eligibility criteria: Inclusion Criteria:

* Age 6-18
* Patient has received chemotherapy, radiation, or a combination of both.
* Patient is at least 12 months post-competion of therapy but no more than five years post-completion of therapy.

Exclusion Criteria:

* No ongoing pharmacological management of ADHD
* Not currently pregnant

Primary outcomes:
measure: Conner's Parent Rating Scale (CPRS)
Secondary outcomes:
measure: Conner's Teacher Rating Scale (CTRS)
measure: Continuous Performance Test (CPT)
measure: Side Effects Rating Scale
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
Study officials:
affiliation: Temple University
name: Ronald T Brown, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05694338: Frailty in Patients With Gastrointestinal Cancer Who Are Undergoing Major Surgery
Official title: A Descriptive and Comparative Analysis of Frailty in Rural Versus Urban Cancer Patients Undergoing Major Surgical Oncologic Procedures
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gastrointestinal Cancer
Lead sponsor: The Guthrie Clinic
Sponsor class: OTHER
First posted: 2023-01-23
Enrollment: 100
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: Participants with gastrointestinal cancer who are referred for elective major surgery

Brief summary: This research is for patients who have gastrointestinal cancer and have a planned major surgery. The purpose of this research is to identify cancer patients who may be at risk for frailty. Frailty is common in older adults and may include symptoms of weight loss, weakness, fatigue, low activity, slow walking and other illnesses. Frailty may increase the risk of problems after major surgery. The study will involve a survey, a blood sample, and a review of medical records.

Detailed description: The goals of the study are to:

* Describe the rate of frailty in surgical cancer patients
* Assess if frailty correlates with problems (adverse outcomes) after major surgery

Participants taking part will be asked to complete a survey to assess frailty before surgery. The frailty survey is referred to as the Clinical Risk Analysis Index (RAI-C).

Participants will have about 10 ml (2 teaspoons) of blood drawn before surgery. Blood tests will include complete blood count (CBC), vitamin A, creatinine, C-Reactive Protein (CRP), DHEA, albumin, and prealbumin.

Eligibility criteria: Inclusion Criteria:

* 18 years old or older
* histologically proven gastrointestinal malignancy
* referral for elective major surgical procedures at including operations for upper and lower gastrointestinal malignancies and hepato-pancreato-biliary
* referral for neoadjuvant treatment followed by any of the above major surgical procedures

Exclusion Criteria:

* under 18 years
* pregnant women

Primary outcomes:
measure: Percent of patients considered frail assessed by Clinical Risk Analysis Index (RAI-C) Scores of 21 or higher
timeFrame: pre-operative
Secondary outcomes:
measure: Adverse outcomes after major surgery
timeFrame: 30 days post-operative
Other outcomes:
Locations:
city: E. Corning
country: United States
facility: Guthrie Medical Group
state: New York
city: Sayre
country: United States
facility: Robert Packer Hospital
state: Pennsylvania
Study officials:
affiliation: The Guthrie Clinic
name: Rebekah Macfie, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03719638: Comparison of Two Blades of Videolaryngoscope in Simulated Difficult Airway in Children
Official title: Comparison of Two Blades of Videolaryngoscope in Simulated Difficult Airway in Children, a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation;Difficult
Keywords: D-Blade
Macintosh videolaryngoscope blade
Simulated difficult intubation
Lead sponsor: Kocaeli University
Sponsor class: OTHER
First posted: 2018-10-25
Enrollment: 47
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Airway management and tracheal intubation are routinely performed in paediatric anaesthesia and yet are associated with preventable adverse events. The D-blade of videolaryngoscope is preferred in difficult intubation with a more curved blade then the Macintosh videolaryngoscope blade, which may be more useful in difficult intubation. The aim of the study is to compare the D-blade of videolaryngoscope with Macintosh videolaryngoscope blade.


Eligibility criteria: Inclusion Criteria:

* ASA I-II patients
* Undergoing elective surgeries
* Age between 1-5 years

Exclusion Criteria:

* Anticipated difficult intubation
* Pulmonery diseases
* \>III ASA scores

Primary outcomes:
measure: intubation time
timeFrame: time between handling videolaryngoscope and inserting endotracheal tube
Secondary outcomes:
measure: Cormack and Lehane score
timeFrame: During the intubation
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: Kocaeli University
Study officials:
affiliation: Kocaeli University School of Medicine
name: Alparslan Kus, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04003038: Negative Pressure Wound Therapy in Healing Abdominal Incision in Obese Patients Undergoing Breast Reconstruction Surgery
Official title: A Randomized, Prospective Evaluation of Negative Pressure Wound Therapy on Abdominal Donor Site in Free Flap Breast Reconstruction in Obese Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Body Mass Index Greater Than or Equal to 30
Malignant Breast Neoplasm
Mammoplasty Patient
Obesity
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-07-01
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This trial studies the safety and how well negative pressure wound therapy works in healing the abdominal incision in obese patients undergoing free flap breast reconstruction surgery. Using negative pressure wound therapy (NPWT) instead of standard dressing (bandages) may improve wound healing at the surgical site in the abdomen where tissue was collected for breast reconstruction surgery.

Detailed description: PRIMARY OBJECTIVES:

I. Determine the impact of negative pressure wound therapy on wound healing as measured by wound dehiscence rate.

II. Long-term follow-up on wound healing complications.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients receive wound care with a standard dressing (bandage) after surgery for 7 days.

GROUP II: Patients receive negative pressure wound therapy (NPWT) after surgery for 7 days.

After completion of study, patients are followed up at 2 weeks, and at 1 and 3 months.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing a free abdominal flap, including a superficial inferior epigastric artery (SIEA), deep inferior epigastric artery perforator (DIEP), or muscle-sparing transverse rectus abdominus myocutaneous (MS-TRAM) flap for breast reconstruction.
* Patients are willing and able to give consent.
* Body mass index (BMI) greater than or equal to 30.0.

Exclusion Criteria:

* Patients who are unable to provide consent.
* Patients who are suspected or known to be pregnant.
* Known allergy to topical adhesives.

Primary outcomes:
measure: Rate of wound dehiscence
timeFrame: Up to 3 months
measure: Wound healing complications
timeFrame: Up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Edward H Chang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02625038: Evaluation of the Intraoperative Accuracy of 3D-planned and Guided Osteotomies of the Hand and Forearm
Official title: CT-based Evaluation of the Intraoperative Implementation Accuracy of 3D-planned Osteotomies of the Hand and Forearm Performed With Patient-specific Instruments
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic or Congenital Bone Deformity
Lead sponsor: Balgrist University Hospital
Sponsor class: OTHER
First posted: 2015-12-09
Enrollment: 110
Sex: ALL
Minimum age (years): 15
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Target of the study is to evaluate the reduction accuracy of 3D computer-planned osteotomies that are performed with patient-specific instruments.

Due to the higher accuracy achieved it is expected that complaints can be resolved or effectively revealed. The Research hypothesis to prove is "The medical product permits the surgical reduction of deformed bones of the hand and forearm (radius, ulna, distal humerus, carpal, metacarpal, and finger bones) by corrective osteotomy within an accuracy of 2 mm and 2º. Secondary outcome is an assessment of the surgical outcome using the "Disabilities of the Arm, Shoulder and Hand" (DASH) and the "Patient related wrist Evaluation" (PRWE) scores.


Eligibility criteria: Inclusion criteria

* Posttraumatic or congenital bone deformity or pseudoarthrosis in the field of hand Surgery requiring correction by corrective osteotomy
* Clinical indication for a computer tomography scan of the forearms
* \> 18 years old
* written informed consent

Exclusion criteria

* pregnant or nursing women
* other clinical significant accompanying symptoms (Tumor, infection)
* non-compliance of the patient to follow the clinical study protocol, drug or alcohol abuse
* Participation in a different clinical trial within the last 30 days before inclusion or during the study

Primary outcomes:
measure: 3D difference between preoperative plan and surgery
timeFrame: 42 month
Secondary outcomes:
measure: Surgical Outcome
timeFrame: 42 month
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Balgrist
Study officials:
affiliation: University of Zurich
name: Andreas Schweizer, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00866138: Masitinib in Relapse or Refractory Multiple Myeloma With t(4/14) Translocation Expressing or Not FGFR3
Official title: Phase II Study of AB1010 in Patients With Relapse or Refractory Multiple Myeloma With t(4/14) Translocation Expressing or Not Expressing FGFR3
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Myeloma
Keywords: multiple myeloma
t(4/14)
relapsing
refractory
Lead sponsor: AB Science
Sponsor class: INDUSTRY
First posted: 2009-03-20
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This phase 2 study was designed to assess the safety and efficacy of masitinib (AB1010) in patients with relapsing/refractory t(4;14) Multiple Myeloma. Response and progression were assessed according to the Bladé revised IMWG criteria1 from lowest point.


Eligibility criteria: Inclusion Criteria:

* Confirmed multiple myeloma with a t (4; 14) translocation by FISH and PCR, expressing or not expressing FGFR3 identified by FACS
* Patients with Multiple Myeloma progressing or relapsing after at least two prior therapies (including conventional chemotherapy and/or high dose therapy) or who get a reduction of M-protein less than 75% within 3 months after a high dose treatment (Melphalan 200mg/m2) or after the plateau obtained for 3 months duration following to a conventional chemotherapy
* Patient with rapidly progressive disease with cytopenia and / or renal failure have to be stabilized with chemotherapy (if possible 3 cycles of VTD ( Bortezomib/Thalidomide/dexamethasone) or high dose Melphalan regimen followed by a 4 weeks washout period before the inclusion in the study.
* Patients must have a clearly detectable and quantifiable monoclonal M- component value (\>5 g/l) in the serum and / or urine light chain excretion (\>0,5 g/d)

Exclusion Criteria:

* Prior corticosteroids within two weeks before enrolment
* Prior local irradiation within two weeks before enrolment
* Prior experimental or standard treatment (other than steroids and local irradiation) within 30 days before enrolment

Primary outcomes:
measure: Tumor Response Rate, based on the criteria published by Blade and on the criteria SWOG
timeFrame: 16 weeks
Secondary outcomes:
measure: Tumor response rate with AB1010 plus dexamethasone
timeFrame: 16 weeks
measure: Time to tumor progression and duration of response in responder patients
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Paris
country: France
facility: Hopital Saint Louis
Study officials:
References:
Clinical trial NCT01534338: Effect of Mindfulness Training on Sleep and Inflammation Among Older Adults With Sleep Problems
Official title: A Randomized Controlled Trial Testing the Effect of Mindfulness Practices Versus Sleep Education on Sleep and Inflammation Among Older Adults With Sleep Problems
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Sleep Problems
Inflammation
Keywords: Sleep
inflammation
mindfulness
meditation
randomized controlled trial
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2012-02-16
Enrollment: 48
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary aim of the study is to test the effect of mindfulness training on sleep parameters among older adults with insomnia symptoms

The secondary aims are to examine if changes in mindfulness meditation practice (daily log) and level of mindfulness (self-report) are associated with changes in sleep parameters, and to determine if mindfulness training is associated with in vitro biological markers of peripheral inflammation


Eligibility criteria: Inclusion Criteria:

* Men and women (all races and ethnicities) 55 years of age and older
* Have current problems sleeping
* Fluent in English
* Able to understand and provide signed informed consent
* Willing to be randomly assigned to treatment condition

Exclusion Criteria:

* Individuals currently undergoing major medical treatment such as surgery, radiation, or immunotherapy
* Individuals living outside of a 20 mile radius from the UCLA Medical Center
* Individuals with current substance dependence

Primary outcomes:
measure: Sleep
timeFrame: Within 2 weeks post-intervention
Secondary outcomes:
measure: Mindfulness
timeFrame: Within 2 weeks post-intervention
measure: Inflammatory Biology
timeFrame: Within 2 weeks post-intervention
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
Study officials:
affiliation: University of California, Los Angeles
name: David S Black, M.P.H., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Black DS, O'Reilly GA, Olmstead R, Breen EC, Irwin MR. Mindfulness meditation and improvement in sleep quality and daytime impairment among older adults with sleep disturbances: a randomized clinical trial. JAMA Intern Med. 2015 Apr;175(4):494-501. doi: 10.1001/jamainternmed.2014.8081.