louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04714658: Education Program in Myasthenia
Official title: Efficiency of a Therapeutic Patient Education Program in Myasthenia Gravis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Auto-immune Myasthenia
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2021-01-19
Enrollment: 100
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: Patient therapeutic education (PTE) has become "a must" in the modern management of chronic diseases. Its main objective is to improve compliance with treatment and the application of preventive measures. The main goal of this study is to assess the influence of the therapeutic education program on the perception of the disease in patients with autoimmune myasthenia. Secondary objectives are to assess quality of life, patient satisfaction of the PTE program, the acquisition of therapeutic goals and the influence of therapeutic education on the evolution of autoimmune myasthenia Study team hypothesize that therapeutic education could improve the patient's perception of myasthenia and its quality of life. By improving patient's adherence to treatments and his knowledge of the disease, it could also improve the evolution of myasthenia gravis. Study team suppose that PTE program can reduce the absenteeism at work, the number and duration of hospitalizations, particularly those in intensive care units.


Eligibility criteria: Inclusion Criteria:

* Patient with generalized autoimmune myasthenia with Acetylcholine Receptor Antibodies (AChR Ab) or with antibodies to the muscle-specific receptor tyrosine kinase (MuSK Ab)
* Patient agreeing to participate in the therapeutic education program
* Signing consent
* Subject affiliated with a health insurance social protection regiment

Exclusion Criteria:

* Patients without serological confirmation of myasthenia or pure ocular form
* Patient with cognitive impairment or behavioral problems that, in the investigator's opinion, will compromise their ability to comply with study procedures
* Refusal of the patient to participate in the study
* Patient who has already benefited from the therapeutic education program in myasthenia
* Age \< 18 y.o.
* Subject under safeguarding justice
* Subject under guardianship or under curatorship

Primary outcomes:
measure: Brief Illness Perception Questionnaire
timeFrame: 6 month after the first visit
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02106858: Stivarga Regulatory Post-Marketing Surveillance Study in Korea
Official title: Stivarga® Regulatory Post-Marketing Surveillance Study in Korea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Neoplasms
Keywords: Stivarga / Regorafenib / Metastatic Colorectal Cancer / Metastatic or unresectable locally advanced GIST (Gastrointestinal stromal tumors)
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2014-04-08
Enrollment: 316
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with metastatic colorectal cancer or metastatic or unresectable locally advanced GIST(Gastrointestinal stromal tumors) by physician.

Brief summary: To investigate and collect post-marketing data on the safety of Stivarga in real world practice in its registered indication(s) as required by Health Authority.


Eligibility criteria: * Inclusion Criteria:
* Signed and dated informed consent
* Patients diagnosed with histologically confirmed metastatic colorectal cancer and/or metastatic or unresectable locally advanced gastrointestinal stromal tumors and/or HCC who have been previously treated with sorafenib by physician
* Patients who are prescribed with Stivarga tablet 40mg(Regorafenib) for the first time
* Exclusion Criteria:
* Patients participating in an investigational program with interventions outside of routine clinical practice
* All contra-indications according to the local marketing authorization have to be considered.

Primary outcomes:
measure: Percentage of patients with serious adverse events
timeFrame: Up to 30 days after terminating treatment
measure: Percentage of patients with adverse drug reactions (ADRs)
timeFrame: Up to 30 days after terminating treatment
Secondary outcomes:
measure: Overall response
timeFrame: Up to 6 years
measure: Progression free survival (PFS)
timeFrame: Up to 6 years
measure: Overall survival (OS)
timeFrame: Up to 6 years
Other outcomes:
Locations:
city: Multiple Locations
country: Korea, Republic of
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT03982758: Acute Effect of Isometric Exercise on Blood Pressure in Hypertensive Patients
Official title: Acute Effect of Isometric Physical Exercise on Blood Pressure in Patients With Controlled Hypertension
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Arterial Hypertension
Lead sponsor: Instituto de Cardiologia do Rio Grande do Sul
Sponsor class: OTHER
First posted: 2019-06-12
Enrollment: 80
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: International recommendations advocate dynamic or isometric strength training as an adjunct to aerobic exercise. Due to a lack of consensus, this research addresses the acute effects of isometric exercises by handgrip or lower limb isometry as a hypotensive strategy in hypertensive adults.

Detailed description: This study is characterized as a randomized, controlled and blinded clinical trial for the evaluators and carried out integrally in the Laboratory of Clinical Investigation (LIC) of the Cardiology Institute of Rio Grande do Sul / University Foundation of Cardiology (ICFUC). The project follows all recommendations proposed by the CONSORT Statement.

The study will consist of individuals of both genders, aged between 40 and 70 years who have blood pressure above 120mmhg by 80mhg. The participants, after signing the informed consent, answered a questionnaire that will evaluate the habitual level of physical activity and will be submitted to isometric exercises of palmar grip or quadriceps muscle. Pre- and post-exercise blood pressure will be monitored through the ambulatory blood pressure monitoring (ABPM) method.

Eligibility criteria: Inclusion Criteria:

* Controlled hypertensive patients (use of medication) sedentary or physically inactive

Exclusion Criteria:

* Pregnant women;
* Unstable angina;
* Class II, III or IV heart failure;
* Recent cardiovascular event (last 3 months);
* Chronic renal insufficiency;
* Diabetes;
* History of malignant diseases with life expectancy \<2 years;
* Or Orthopedic limitations or any physical or mental limitation that impedes the performance of physical exercises.

Primary outcomes:
measure: blood pressure
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Instituto de Cardiologia/ fundação Universitária de Cardiologia
state: Rio Grande Do Sul
Study officials:
affiliation: Instituto de Cardiologia/ Fundação Universitária de Cardiologia
name: Patricia Caetano, graduate
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05159258: Morphological Analysis and Classification of Posterior Malleolar Fractures Based on CT Scans
Official title: Morphological Analysis and Classification of Posterior Malleolar Fractures Based on CT Scans
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Morphological Analysis and Classification
Posterior Malleolar Fractures
CT Scans
Keywords: Ankle fractures
Posterior malleolar fractures
Classification
Mechanism
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
First posted: 2021-12-16
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: OTA/AO type 44 fractures involving posterior malleolus

Brief summary: The study was to propose a classification system of posterior malleolar fractures by fracture lines with the use of CT scans, including 3D CT reconstruction, which can better understand morphological characteristics, analyze the mechanism and guide the surgeon to choose optimal approach and fixation.

Detailed description: The investigators retrospectively analyzed consecutive patients with ankle fractures from January 2013 and December 2019 . Participants were included with OTA/AO type 44 fractures involving posterior malleolus and CT scans. The exclusion criteria were: (1) previous ankle surgery; (2) pathological fractures; (3) previous deformity in ankle joint; (4) age ≤16 years old. Finally, A total of 128 patients were included in this study. 128 consecutive participants with posterior malleolar fractures from January 2013 and December 2019. CT data were loaded into Mimics software (V20.0, Materialize), in which 3D CT reconstruction, morphological analysis and data measurements were made. Statistical analysis was performed using the Statistical Packages for Social Sciences V23.0 (SPSS, Chicago, IL, USA). Mann-Whitney U test were used. P value of \< 0.05 was considered statistically significant.

Eligibility criteria: Inclusion Criteria:

* OTA/AO type 44 fractures involving posterior malleolus and CT scans

Exclusion Criteria:

* Previous ankle surgery
* Pathological fractures
* Previous deformity in ankle joint
* Age ≤16 years old

Primary outcomes:
measure: posterior malleolar fracture classification
timeFrame: 2013-2019
measure: area of posterior malleolar fragment
timeFrame: 2013-2019
measure: area of remaining stable plafond
timeFrame: 2013-2019
measure: length of remaining fibular notch
timeFrame: 2013-2019
measure: length of involving fibular notch
timeFrame: 2013-2019
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03427658: Repeated Sweet Consumption and Subsequent Sweet Food Preferences and Intake
Official title: Impact of Repeated Sweet and Non-sweet Food Consumption on Subsequent Sweet Food Preferences and Intake
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Repeated Sweet Food Consumption
Keywords: sweet taste
food preferences
food intake
Lead sponsor: Bournemouth University
Sponsor class: OTHER
Collaborators: name: University of Bristol
First posted: 2018-02-09
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study will assess the impact of repeated sweet versus non-sweet food consumption on subsequent sweet and non-sweet food preferences and intakes

Detailed description: Participants will be randomized to receive instructions to either increase or decrease sweet food consumption for 6 days, and impacts on food preferences and intakes will be assessed at baseline and after 1 week. Preferences for sweet and non-sweet foods will be assessed during two taste tests at each assessment time, where six different foods will be rated. Sweet and non-sweet food consumption will also be measured at two meals at each assessment time - breakfast and lunch. Identical buffet meals composed of sweet and non-sweet foods suitable for consumption at breakfast and lunch will be provided ad-libitum.

Eligibility criteria: Inclusion Criteria:

* No known food allergy
* No known taste or appetite allergies
* Non-smokers
* Do not habitually consume exclusively / almost exclusively a sweet or non-sweet diet
* Able to provide consent and complete all study measures

Race / ethnicity will not be requested.

Primary outcomes:
measure: Food Preferences
timeFrame: Change from Baseline to 1 week
measure: Food Intake
timeFrame: Change from Baseline to 1 week
Secondary outcomes:
measure: Hunger Ratings
timeFrame: Change from Baseline to 1 week
Other outcomes:
Locations:
city: Bristol
country: United Kingdom
facility: University of Bristol
Study officials:
affiliation: University of Bristol
name: Peter Rogers, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Bournemouth University, UK
name: Katherine Appleton, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00442858: Incidence of Cardiovascular Diseases in Patients With Hypopituitarims
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Keywords: cardiac disease
cerebrovascular disease
GH deficiency
diabetes mellitus
hypertension
GH therapy
GH deficiency and hypopituitarims
Lead sponsor: Lund University Hospital
Sponsor class: OTHER
First posted: 2007-03-05
Enrollment: 800
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: DEFINED_POPULATION
Time perspective: RETROSPECTIVE

Brief summary: The aim of the present study was therefore two-fold: 1) to make a retrospective comparison of incidence of non-fatal stroke and cardiac events between a large cohort of patients with confirmed GHD on replacement therapy (including GH) and a control cohort from the general population; 2) to compare the prevalence of DM and cardioprotective medication between the cohorts at the time of questionnaire distribution with adjustment for possible confounders and effect modifiers.


Eligibility criteria: Inclusion Criteria:

* Confirmed GH deficiency

Exclusion Criteria:

* Not confirmed GH deficiency

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Endocrine Unit, Department of Medicine, University Hospital, Lund
name: Eva Marie T Erfurth, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05216458: Using Personalized Letters and Emails to Increase Health Insurance Take-up and Improve Plan Choice Quality
Official title: Using Personalized Letters and Emails to Increase Health Insurance Take-up and Improve Plan Choice Quality in California's ACA Marketplace
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Behavior
Keywords: Affordable Care Act
randomized controlled trial
nudge
American Rescue Plan
Lead sponsor: Office of Evaluation Sciences
Sponsor class: FED
First posted: 2022-01-31
Enrollment: 44000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: With the passage of the American Rescue Plan (ARP) in March 2021, more consumers than ever before are now eligible for $0 -- or $1 per member per month (PMPM) in Marketplaces that include abortion coverage -- health insurance coverage across the ACA Marketplaces. But many individuals may not be aware of the new subsidies, or of their eligibility for Cost-Sharing Reduction (CSR) Silver plans. This project's goal is to examine whether personalized letters and email reminders can increase health insurance enrollment, CSR Silver take-up and $1 PMPM coverage.


Eligibility criteria: Inclusion Criteria:

* Submitted a Covered California application for the 2021 coverage year and found eligible for a $1 PMPM Enhanced Silver 94 plan

Exclusion Criteria:

-

Primary outcomes:
measure: Percent of households enrolled in an ACA plan
timeFrame: Three months
measure: Percent of households who chose a CSR Silver plan
timeFrame: Three months
measure: Percent of households who enrolled in a $1/month net-of-subsidy premium plan
timeFrame: Three months
Secondary outcomes:
measure: Percent of households who logged into their online account
timeFrame: Three months
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: Covered California
state: California
Study officials:
affiliation: Covered California
name: Andrew Feher, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02827058: The Influence of Needle Diameter on Post Dural Puncture Headache
Official title: The Influence of Needle Diameter on Needle Failures and Post Dural Puncture Headache in Relation to Cesarean Section and Vaginal Delivery; a Prospective, Randomised Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Post-Dural Puncture Headache
Keywords: Delivery, obstetric
Analgesia, Epidural
Injections, Epidural
Needles
Cesarean Section
Lead sponsor: Helse Nord-Trøndelag HF
Sponsor class: OTHER
Collaborators: name: Sykehuset Ostfold
First posted: 2016-07-11
Enrollment: 65
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine whether injection needle pen point type 'PP Gauge 25' should be recommended as a primary choice of needle (in stead of 'PP Gauge 27') for healthy pregnant women who at delivery (vaginal or cesarean section) get spinal anesthesia.


Eligibility criteria: Inclusion Criteria:

* healthy
* pregnant
* spinal anesthesia at delivery (vaginal delivery or cesarean section emergency grade 2-4)
* informed consent

Exclusion Criteria:

* chronic headache
* (attempt to) epidural anesthesia

Primary outcomes:
measure: number of attempts until successful injection
timeFrame: 0 (injection time before delivery)
Secondary outcomes:
measure: incidence of post dural puncture headache
timeFrame: 48 hrs
Other outcomes:
Locations:
city: Fredrikstad
country: Norway
city: Fredrikstad
country: Norway
facility: Østfold Hospital
city: Levanger
country: Norway
facility: Levanger Hospital
Study officials:
affiliation: Østvold Hospital
name: Jan Sverre Vamnes, md
role: STUDY_DIRECTOR
References:
Clinical trial NCT03529058: Hypophosphatemia as a Predictive Marker of Mortality During Sepsis in ICU
Official title: Evaluation of Hypophosphatemia as a Predictive Marker of Mortality During Sepsis in ICU
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypophosphatemia
Infection
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2018-05-18
Enrollment: 193
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients admitted to 21-bed medical ICU, 15-bed surgical ICU and 8-bed cardiothoracic ICU between June 1, 2014 and December 31, 2015 were screened for inclusion.

Brief summary: Retrospective study in the 3 intensive care units of the Brest Teaching Hospital (France) during a 18-months period (June 2014 -December 2015) to study the independent association between hypophosphatemia and 90-day mortality.


Eligibility criteria: Inclusion Criteria:

* Blood stream infection

Exclusion Criteria:

* Less than 18 years old

Primary outcomes:
measure: 90-day mortality
timeFrame: 90 days since the first blood stream infection in ICU
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
Study officials:
References:
citation: Padelli M, Aubron C, Huet O, Hery-Arnaud G, Vermeersch V, Hoffmann C, Bettacchioli E, Maguet H, Carre JL, Leven C. Is hypophosphataemia an independent predictor of mortality in critically ill patients with bloodstream infection? A multicenter retrospective cohort study. Aust Crit Care. 2021 Jan;34(1):47-54. doi: 10.1016/j.aucc.2020.05.001. Epub 2020 Jul 27.
Clinical trial NCT02343796: Clinical Follow-up of Direct/Indirect Bridge, Orthodontic and Periodontal Splint by Using Fibre-reinforced Composite
Official title: Clinical Follow-up of Direct/Indirect Bridge, Orthodontic and Periodontal Splint Applications by Using Fibre-reinforced Composite.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tooth Loss
Tooth Mobility
Keywords: Fiberglass reinforced resins
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2015-01-22
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
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 determine whether fibre-reinforced composite resin restorations are effective for single tooth replacement, elimination of tooth mobility following periodontal treatment and as an orthodontic retainer.

Detailed description: Adhesive dentistry is based on preventive dental approach. In presence of such advanced and minimally invasive techniques, destructive treatment methods should not be preferred for clinical situations, such as missing single tooth cases, tooth mobility following periodontal treatment and prevention of relapse after orthodontic treatments. Glass fibre is a reinforcement material, and increases the flexibility of the material together which it has been used. Fibre-reinforced applications by using direct or indirect techniques. This material and method is easily applicable, biocompatible, repairable and economical on a high extent.

Eligibility criteria: Inclusion Criteria:

* referring patients for missing tooth replacement or fixation of tooth mobility following periodontal treatment or maintenance of teeth in corrected positions following orthodontic treatment

Exclusion Criteria:

* insufficient interocclusal distance
* poor oral hygiene

Primary outcomes:
measure: Number of participants with clinical survival of the applied restoration, splint or retainer, as indicated by observations for any fractures on composite.
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Izmir
country: Turkey
facility: Ege University
Study officials:
affiliation: Ege University
name: Ovul Kumbuloglu, Assoc Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kumbuloglu O, Ozcan M, User A. Fracture strength of direct surface-retained fixed partial dentures: effect of fiber reinforcement versus the use of particulate filler composites only. Dent Mater J. 2008 Mar;27(2):195-202. doi: 10.4012/dmj.27.195.