louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05711771: Medication Therapy Management (MTM) for a Medicaid Managed Care Population Within Patient-Centered Medical Homes
Official title: Medication Therapy Management (MTM) for a Medicaid Managed Care Population Within Patient-Centered Medical Homes
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Medication Therapy Management
Estimated Cost Avoidance
MTM
Medication Management
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2023-02-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients of the CareSource™ Medicaid managed care population who have a primary care physician within the patient-centered medical homes of The Ohio State University Division of General Internal Medicine

Brief summary: The primary objective of this project is to determine the estimated cost avoidance (ECA) resulting from medication therapy management (MTM) interventions in a patient-centered medical home (PCMH). The secondary objective of this study is to quantify the number and types of MTM interventions recommended by pharmacists and accepted by physicians within a PCMH.

Detailed description: CareSource™, the largest Medicaid managed care provider in Ohio, pays for pharmacist-provided MTM using the OutcomesMTM™ platform for claims submissions. In May of 2013, pharmacists at three PCMHs affiliated with a large academic medical center began providing MTM to patients with CareSourceTM through the OutcomesMTMTM platform. A retrospective chart review of the OutcomesMTM™ platform was performed for all patients who received MTM services between May 2013 and October 2014. The number and type of MTM interventions was tracked. For each intervention, the ECA level submitted to and accepted by the third party reviewer was collected. The ECA will be calculated using the cost associated to the CareSource™ managed care provider for each ECA level.

Eligibility criteria: Inclusion Criteria:

* Patient of a primary care doctor within The Ohio State University Division of General Internal Medicine
* CareSource™ Medicaid managed care as the insurance provider

Exclusion Criteria:

* n/a

Primary outcomes:
measure: Estimated cost avoidance
timeFrame: 1.5 years of data collected retrospectively
Secondary outcomes:
measure: Number of medication therapy management claims made
timeFrame: 1.5 years of data collected retrospectively
measure: Types of medication therapy management claims made
timeFrame: 1.5 years of data collected retrospectively
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01109771: Absorbable Versus Permanent Mesh Fixation Trial in Laparoscopic Midline Ventral Hernia Repair
Official title: Absorbable Versus Permanent Mesh Fixation Trial in Laparoscopic Midline Ventral Hernia Repair (SORBET Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventral Hernia
Keywords: Ventral hernia
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: Medtronic - MITG
First posted: 2010-04-23
Enrollment: 105
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: To compare the use of absorbable tackers versus permanent tack fixation using a polyester large pore mesh in laparoscopic midline ventral hernia repair in a multicenter (Belgian) prospective randomized single-blinded trial.

All patients referred for elective midline ventral hernia repair should be assessed for eligibility and entered in a study log, detailing all included patients during the study period.


Eligibility criteria: Inclusion Criteria:

* written informed consent from the adult patient (18 years and older, no maximum age)
* primary, incisional or recurrent midline ventral hernia requiring elective laparoscopic repair

Exclusion Criteria:

* no written informed consent
* hernia defects larger than 10cm diameter in width
* 'hostile' abdomen; open abdomen treatment
* contraindication to pneumoperitoneum
* emergency surgery (incarcerated hernia)
* lateral or parastomal hernia sites

Primary outcomes:
measure: number of patients with a VAS scale more than 40
timeFrame: 1 year after surgery
Secondary outcomes:
measure: number of invasive interventions (local infiltrations, reoperations) postoperatively
timeFrame: 1 year after surgery
measure: number of patients taking analgetics using MCGill painscore
timeFrame: 1 year post-surgery
measure: perioperative morbidity rate
timeFrame: 1 year after surgery
measure: quality of life by using EQ5D score
timeFrame: 1 year post-surgery
measure: recurrence rate
timeFrame: 1 year post-surgery
Other outcomes:
Locations:
city: Hasselt
country: Belgium
facility: Virga Jesseziekenhuis
state: Limburg
city: Bonheiden
country: Belgium
facility: Imelda Ziekenhuis
city: Charleroi
country: Belgium
facility: CHU Charleroi
city: Deinze
country: Belgium
facility: St-Vincentius Ziekenhuis
city: Geel
country: Belgium
facility: AZ Sint-Dymphna
city: Ghent
country: Belgium
facility: University Hospital Ghent
city: Maaseik
country: Belgium
facility: Ziekenhuis Maas en Kempen
city: Mechelen
country: Belgium
facility: AZ Sint-Maarten
city: Mol
country: Belgium
facility: Heilig Hart Ziekenhuis
city: Namur
country: Belgium
facility: UCL Mont-Godinne
city: Oostende
country: Belgium
facility: H. Serruys Ziekenhuis
Study officials:
affiliation: University Hospital, Ghent
name: Frederik Berrevoet, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02828371: Early Stepping Verticalization in ICU for ABI Patients
Official title: Effectiveness of a Very Early Stepping Verticalization Protocol in Severe Acquired Brain Injured Patients: a Randomized Pilot Study in ICU
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Injury
Consciousness Disorders
Lead sponsor: Ospedale Generale Di Zona Moriggia-Pelascini
Sponsor class: OTHER
First posted: 2016-07-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Verticalization was reported to improve the level of arousal and awareness in patients with severe acquired brain injury (ABI) and to be safe in ICU. The investigators evaluated the effectiveness of a very early stepping verticalization protocol on the functional and neurological outcome of patients affected by disorder of consciousness due to ABI.

Consecutive patients with Vegetative State or Minimally Conscious State were enrolled in ICU on the third day after an ABI. They were randomized to undergo conventional physiotherapy alone or associated to fifteen 30-minute sessions of verticalization, using a tilt table with robotic stepping device. Once stabilized, patients were transferred to a Neurorehabilitation unit for an individualized treatment. Outcome measures were assessed on the third day from the injury (T0), at ICU discharge (T1) and at Rehab discharge (T2).


Eligibility criteria: Inclusion Criteria:

* Glasgow Coma Scale (GCS) ≤8 for ≥24h from the event;
* diagnosis of vegetative state or minimally conscious state on the third day after the injury;
* adequate pulmonary gas exchanging function;
* stable hemodynamics

Exclusion Criteria:

* sedation;
* unstable intracranial pressure (ICP);
* cerebral perfusion pressure (CPP) \<60 mmHg;
* fractures or skin lesions in thorax, abdomen or lower limbs;
* deep vein thrombosis;
* body weight \>130 kg; height \>210 cm.

Primary outcomes:
measure: Coma Recovery Scale change
timeFrame: through study completion, average 18 weeks
measure: Glasgow Coma Scale change
timeFrame: through study completion, average 18 weeks
measure: Levels of Cognitive Functioning change
timeFrame: through study completion, average 18 weeks
measure: Disability Rating Scale change
timeFrame: through study completion, average 18 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Gravedona ed Uniti
country: Italy
facility: Ospedale Generale di Zona "Moriggia Pelascini"
state: CO
Study officials:
References:
citation: Frazzitta G, Zivi I, Valsecchi R, Bonini S, Maffia S, Molatore K, Sebastianelli L, Zarucchi A, Matteri D, Ercoli G, Maestri R, Saltuari L. Effectiveness of a Very Early Stepping Verticalization Protocol in Severe Acquired Brain Injured Patients: A Randomized Pilot Study in ICU. PLoS One. 2016 Jul 22;11(7):e0158030. doi: 10.1371/journal.pone.0158030. eCollection 2016.
Clinical trial NCT01152671: A Study of RO5024048 in Japanese and Caucasian Healthy Volunteers
Official title: A Multiple Center Randomized, Double-Blind, Single-Ascending-Dose, Placebo-Controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics Following Oral Administration of RO5024048 in Healthy Japanese and Caucasian Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-06-29
Enrollment: 97
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This randomized, double-blind, placebo-controlled study will assess the safety, tolerability and pharmacokinetics of RO5024048. Japanese and Caucasian healthy volunteers will be randomized to receive either single oral doses of RO5024048 or placebo. Follow-up is 7-10 days.


Eligibility criteria: Inclusion Criteria:

* Healthy male and female adults, 20 to 55 years of age, inclusive
* Body mass index (BMI) 18 - 30 kg/m2 inclusive
* Non-smoker, or previous smoker who discontinued smoking \>/= 6 month prior to study entry
* Japanese subjects must be first generation: born in Japan, not having lived outside Japan \>5 years, able to trace maternal and paternal Japanese ancestry
* Female subjects of childbearing potential and male subjects and their partners of childbearing potential must agree to use two forms of contraception
* Agree to abstain from alcohol consumption and from strenuous exercise up to 3 days before dosing and throughout study (including the follow-up visit)

Exclusion Criteria:

* Positive pregnancy test
* Males whose female partner is pregnant or trying to become pregnant
* Positive urine test for drugs of abuse
* Positive for alcohol
* Positive result on hepatitis B, hepatitis C, or HIV test
* Clinically significant disease or abnormalities in laboratory parameters
* Participation in an investigational drug, biologic or device study within 3 months before study drug administration
* Donation or loss of any blood over 450 mL within 3 months before study drug administration

Primary outcomes:
measure: Pharmacokinetics of RO4995855 (parent of the prodrug RO5024048) and its metabolite(s)
timeFrame: Day 1 to Day 4
Secondary outcomes:
measure: Safety and tolerability: Adverse events, laboratory parameters, ECG
timeFrame: Day 1 to Day 10
Other outcomes:
Locations:
city: Glendale
country: United States
state: California
city: Eatontown
country: United States
state: New Jersey
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT00002171: A Study of Viracept in HIV-Positive Women
Official title: A Phase II, Randomized, Placebo-Controlled Study of the Safety and Efficacy of Viracept in Combination With Antiretroviral Therapy in HIV Positive Women With <= 1 Month of Prior Treatment With d4T and/or 3TC
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Infections
Keywords: Placebos
Drug Therapy, Combination
Stavudine
HIV Protease Inhibitors
Lamivudine
Nelfinavir
Anti-HIV Agents
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Sex: FEMALE
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see if it is safe and effective to give Viracept plus stavudine (d4T) plus lamivudine (3TC) to HIV-positive women with a CD4 count \<= 400 cells/mm3. This study also examines how the body handles Viracept when given with d4T and 3TC.


Eligibility criteria: Inclusion Criteria

Patients must have:

* HIV infection.
* CD4 T cell count \<= 400 cells/mm3.

Exclusion Criteria

Prior Medication:

Excluded:

* Prior therapy or less than 1 month of therapy with d4T and/or 3TC.
* Prior protease inhibitor therapy.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Univ of Alabama at Birmingham
state: Alabama
city: Los Angeles
country: United States
facility: Univ of Southern California / LA County USC Med Cntr
state: California
city: New Orleans
country: United States
facility: HIV Outpatient Clinics / LA State Univ Med Ctr
state: Louisiana
city: Houston
country: United States
facility: Baylor Univ
state: Texas
Study officials:
References:
Clinical trial NCT02213471: Patient Preference for Biopsy Notification
Official title: Patient Preference for Biopsy Notification
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Elevated Risk for Melanoma
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2014-08-11
Enrollment: 301
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: Individuals at increased risk for melanoma due to past history of melanoma, family history of melanoma, the presence of many moles, the presence of a genetic mutation known to increase the risk of melanoma. Individuals were followed in a Pigmented Lesion Clinic.

Brief summary: Effective communication between physician and patient is fundamental to effective care. The recent introduction of electronic patient on-line portals has the potential to change the communication landscape. The investigators surveyed patients to assess their preferred modality for biopsy notification at 3 institutions with differing patient access to on-line portals, to ascertain what patient preferences are currently and if it has changed from historical preferences. Our hypothesis is that as patients become more familiar with ln-line portals, their preferences will likely reflect familiarity with this modality.


Eligibility criteria: Inclusion Criteria:

* Patients who were 18 years of age or older and English speaking were eligible to participate

Exclusion Criteria:

* Younger than 18, non-English speaking.

Primary outcomes:
measure: Patient preference for biopsy notification
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California
state: California
Study officials:
affiliation: University of California, San Francisco
name: Maria L Wei, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05014971: Telehealth in Lewy Body Dementia
Official title: Multi-Stakeholder Engagement for Interdisciplinary Telehealth in Lewy Body Dementia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lewy Body Dementia With Behavioral Disturbance
Lewy Body Parkinson Disease
Lewy Body Disease
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2021-08-20
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: tele-neurohub model of care
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Lewy body dementia (LBD) is the 2nd most common neurodegenerative dementia in the US. Optimal care requires an interdisciplinary approach, however often faced barriers include rural residence, limited access to specialists, travel distance, limited awareness of resources, and physical, cognitive, and behavioral impairments making travel to appointments challenging. Delivering interdisciplinary care remotely using video technology has the potential to improve access to care for patients with LBD.

Detailed description: The purpose of this study is to convert an in-person patient-centric interdisciplinary care model to a virtual platform using stakeholder engagement from individuals with LBD, their caregivers and healthcare providers. Subsequently researchers will conduct a prospective, randomized, controlled pilot study implementing the virtual stakeholder developed interdisciplinary care model (tele-neurohub) for 6 month and assess the implementation outcomes of feasibility, acceptability, and appropriateness of the tele-neurohub model. The research goal is to establish and iteratively improve a virtual interdisciplinary model of care allowing patients with LBD and their caregivers to access sub-specialty care from their home.

Eligibility criteria: Participant with Lewy Body Dementia (LBD) Inclusion Criteria:

* LBD diagnosis by a dementia or movement disorders specialist
* Clinician-determined mild-moderate dementia severity
* Internet access with a Zoom-compatible device
* Caregiver who resides in the patient's home and is willing to participate
* Fluency in English

Primary outcomes:
measure: Number of completed tele-health visits
timeFrame: 6 months
Secondary outcomes:
measure: Satisfaction assessed by Patient Assessment of Communication of Telehealth questionnaire.
timeFrame: 6 months
measure: Appropriateness assessed by Intervention Appropriateness Measure
timeFrame: 6 months
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Bhavana Patel, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05204771: Prenatal US Assessment of Superior Mesenteric Vessels for Digestive Rotation
Official title: Prenatal Ultrasound Assessment of the Relative Position of the Superior Mesenteric Artery and Vein to Define the Status of Digestive Rotation: a Prenatal Tool of Intestinal Malrotation Diagnosis?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Singleton-Merten Syndrome
Postnatal Complication
Keywords: Evolution and complication
Mesenteric vessels positionning
3rd ultrasound examination
Pediatric follow up +/- treatment
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2022-01-24
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant women attending for 3rd timester scan

Brief summary: Digestive malrotation is an anatomical anomaly of the positionning of the mesenteric vessels and the digestive tract that can lead in some form to a dangerous neonatal complication: intestinal volvulus. This requires emergency surgery with a risk of digestive resection. Visualizing during pregnancy the normal or abnormal anatomical positionning of the mesenteric vessels could make it possible to diagnose this malrotation and prevent the occurrence of this complication.

The aim of the study is ti evaluate the ability to identiy prenataly during ultrasound examination, the relative positionning of the fetal mesenteric vessels, and then to correlate it with the real postnatal positionning (gold standard)

Detailed description: * Prenatal US assessment of mesenteric vessels positioning (relative position of the vein vs artery) during routine 3rd trimester US scan
* Description of various anatomical situation
* Comparison of this prenatal positioning with postnatal positioning obtained through abdominal ultrasound examination. Post-natal ultrasound being the gold standard

Eligibility criteria: Inclusion criteria:

* Pregnant women attending for 3rd trimester ukltrasound
* Uneventfull pregnancy
* No foetal malformation
* Singleton pregnancy
* Age \>18 years

Exclusion criteria:

- Other condition

Primary outcomes:
measure: Prenatal ultrasound evaluation
timeFrame: day 1
Secondary outcomes:
measure: Prenatal ultrasound evaluation
timeFrame: day 1
measure: Prenatal ultrasound evaluation
timeFrame: day 1
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Florent FUCHS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03189888: Granulocyte-monocyte Apheresis in Ulcerative Colitis
Official title: Granulocyte-monocyte Apheresis in Steroid-dependent, Azathioprine-intolerant/Resistant Moderate Ulcerative Colitis: a Prospective Multicentre Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ulcerative Colitis
Lead sponsor: Valduce Hospital
Sponsor class: OTHER
First posted: 2017-06-16
Enrollment: 33
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: BACKGROUND: Granulocyte-monocyte apheresis has been proposed for the treatment of ulcerative colitis, although is limited by costs and variability of results.


Eligibility criteria: Inclusion Criteria:

* moderate UC with steroid-dependence and azathioprine intolerance or resistance

Primary outcomes:
measure: steroid-free clinical remission
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Imperiali G, Amato A, Terpin MM, Beverina I, Bortoli A, Devani M, Vigano C; Study Group on IBD (GSMII). Granulocyte-Monocyte Apheresis in Steroid-Dependent, Azathioprine-Intolerant/Resistant Moderate Ulcerative Colitis: A Prospective Multicenter Study. Gastroenterol Res Pract. 2017;2017:9728324. doi: 10.1155/2017/9728324. Epub 2017 Dec 21.