louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04295486: Optimal Dosing For Low-Dose Aspirin Chemoprophylaxis For VTE Following Total Joint Arthroplasty
Official title: Optimal Dosing For Low-Dose Aspirin Chemoprophylaxis For Venous Thromboembolism (VTE) Following Total Joint Arthroplasty - A Multi-center Prospective Randomized Control Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Venous Thromboembolism
Keywords: Chemoprophylaxis
Hip Surgery
Knee Surgery
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2020-03-04
Enrollment: 5478
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This research study is attempting to answer the question of whether 81 mg aspirin once daily is as effective as 81 mg aspirin twice daily in preventing blood clots after total joint replacement surgery.


Eligibility criteria: Inclusion criteria:

* \> 18 years of age
* Planning to undergo a primary total hip or knee arthroplasty

Exclusion Criteria:

* High risk patients for VTE as defined by:

  * History of venous thromboembolism
  * Active malignancy
  * Known pro thrombotic condition
* BMI \> 40
* Patients requiring anticoagulation for pre-existing conditions
* Patients with the contraindication for use of aspirin or nonsteroidal antiinflammatory drugs for reasons such as peptic ulcer disease, intolerance, others.
* Patients not fluent in the language of the informed consent form
* Prisoners
* Pregnancy
* Reported to have mental illness or belonging to a vulnerable population

Primary outcomes:
measure: Incidence of symptomatic thromboembolic events
timeFrame: 90 days
Secondary outcomes:
measure: Incidence of specific adverse events
timeFrame: 90 days
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami Hospital
state: Florida
Study officials:
affiliation: University of Miami
name: Victor Hernandez, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00632086: Evaluate Relative Bioavailability of PA32540 (Asa/Omeprazole), Its Aspirin Component, and Ecotrin® in Healthy Volunteers
Official title: A Phase 1, Open-Label, Randomized, 3-Way Crossover Study to Evaluate the Relative Bioavailability of a Single Oral Dose of Aspirin Administered as PA32540 (Aspirin/Omeprazole) or as the Aspirin Component of PA32540 or as Ecotrin® 325 mg in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: PK
Lead sponsor: POZEN
Sponsor class: INDUSTRY
First posted: 2008-03-10
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: Study to determine a single dose bioavailablity of PA32540 is similar to EC aspirin 325 mg with respect to salicylic acid.


Eligibility criteria: Inclusion Criteria:

* Standard for PK
* Ages 18-55 years old
* Males and females

Exclusion Criteria:

* Standard for PK

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02930486: Ziptight or Tricortical Screw Fixation of Acute Tibiofibular Syndesmotic Injury
Official title: Ziptight or Tricortical Screw Fixation of Acute Tibiofibular Syndesmotic Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ankle Fractures
Keywords: Syndesmosis
Injury
Ankle
Fracture
Weber C
Lead sponsor: Vestre Viken Hospital Trust
Sponsor class: OTHER
Collaborators: name: Oslo University Hospital
name: Ostfold Hospital Trust
First posted: 2016-10-12
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Treatment of syndesmotic injury with Weber C fracture. A randomized study comparing ZipTight suture endobutton and one tricortical 3,5 mm syndesmotic screw.

Detailed description: Syndesmotic injuries are common and often associated with unstable ankle fractures. The most common treatment is with a syndesmotic screw through the fibula and tibia which is later removed, usually after 10-12 weeks. The ZipTight suture endobutton (Biomet) is used for the same indication. It does not need removal and thus avoids subsequent surgery. This trial will compare these two methods and see if they are equal.

patients 18-70 years presenting to one of the three hospitals with and acute syndesmotic injury are eligible for inclusion. 120 patients are randomized to two treatment groups. One group will be treated with a ZipTight suture endobutton fixation and the other receives a tricortical screw fixation. Neither suture endobutton or screw is routinely removed. Follow up intervals are at 6 weeks, 6, 12 and 24 months with clinical and-points. Standardized CT scans are taken postoperatively and at 12 and 24 months.

Eligibility criteria: Inclusion Criteria:

* 18 to 70 years
* Acute syndesmotic injury with Weber type C fracture

Exclusion Criteria:

* Prior injury og the same ankle
* Severe injury of the same leg affecting rehabilitation
* Symptomatic osteoarthritis of same ankle
* open injury
* Decubital injury affecting surgical site
* Dementia or unable to sign informed consent
* neuropatic conditions affecting same leg

Primary outcomes:
measure: OTA Score (Modified American Orthopaedic Foot and Ankle Society ankle hind foot score)
timeFrame: 24 months
Secondary outcomes:
measure: Manchester-Oxford Foot questionnaire (MOxFQ)
timeFrame: 24 months
measure: Dorsiflexion angle
timeFrame: 24 months
measure: Health-related quality of life (EQ-5D)
timeFrame: 24 months
measure: CT measurements of syndesmotic distance
timeFrame: 24 months
measure: VAS
timeFrame: 24 months
Other outcomes:
Locations:
city: Sandvika
country: Norway
facility: Baerum Hospital, Vestre Viken
state: Gjettum
Study officials:
References:
citation: Raeder BW, Stake IK, Madsen JE, Frihagen F, Jacobsen SB, Andersen MR, Figved W. Randomized trial comparing suture button with single 3.5 mm syndesmotic screw for ankle syndesmosis injury: similar results at 2 years. Acta Orthop. 2020 Dec;91(6):770-775. doi: 10.1080/17453674.2020.1818175. Epub 2020 Sep 10.
Clinical trial NCT00032786: Safety and Efficacy of Natalizumab in the Treatment of Crohn's Disease
Official title: A Phase 3, International, Multicenter, Double-blind, Placebo-controlled Study of the Efficacy, Safety, and Tolerability of Intravenous Antegren (Natalizumab) in Maintaining Clinical Response and Remission in Subjects With Crohn's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Crohn's Disease
Lead sponsor: Biogen
Sponsor class: INDUSTRY
Collaborators: name: Elan Pharmaceuticals
First posted: 2002-04-04
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 the safety and efficacy of natalizumab in individuals diagnosed with moderate to severely active Crohn's disease. It is thought that natalizumab may stop the movement of certain cells, known as white blood cells, into bowel tissue. These cells are thought to cause damage in the bowel leading to the symptoms of Crohn's disease.


Eligibility criteria: Male and female patients at least 18 years of age who have at least a six-month history of Crohn's disease and who are currently experiencing moderate to severely active Crohn's disease. Women must not be breastfeeding or pregnant, and must not become pregnant during this study. Patient enrollment requires previous participation in study AN100226-CD301 (please refer to the clinical trial listing for CD301).

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Sandborn WJ, Colombel JF, Enns R, Feagan BG, Hanauer SB, Lawrance IC, Panaccione R, Sanders M, Schreiber S, Targan S, van Deventer S, Goldblum R, Despain D, Hogge GS, Rutgeerts P; International Efficacy of Natalizumab as Active Crohn's Therapy (ENACT-1) Trial Group; Evaluation of Natalizumab as Continuous Therapy (ENACT-2) Trial Group. Natalizumab induction and maintenance therapy for Crohn's disease. N Engl J Med. 2005 Nov 3;353(18):1912-25. doi: 10.1056/NEJMoa043335.
Clinical trial NCT01157286: Obstructive Apnea in Patients Submitted to Partial Laryngectomy
Official title: Obstructive Apnea in Patients Submitted to Partial Laryngectomy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: OBSTRUCTIVE SLEEP APNEA
Keywords: OBSTRUCTIVE SLEEP APNEA LARINGECTOMY CPAP
Lead sponsor: Hospital do Servidor Publico Estadual
Sponsor class: OTHER
First posted: 2010-07-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: PATIENTS OVER 18 YEARS, SUBMITED IN THE LAST 15 YEARS TO PARTIAL LARINGECTOMY IFNO TRACHEOSTOMY IS PRESENT

Brief summary: The investigators intend to study the prevalence of obstructive apnea in patients submitted to partial laryngectomy by larynx cancer. Volunteers will be evaluated using polissonografy. We will try to correlate the residual glotic area with the number of apneas per hour.

Detailed description: We are trying to avaliate the residual glotic area using spirometry e laryngoscopy

Eligibility criteria: Inclusion Criteria:

* PARTIAL LARINGECTOMY, OVER 18 YEARS,

Exclusion Criteria:

* TRACHEOSTOMY DEPRESSION USE OF DRUGS SEVERE DPOC CANCER RECURRENCE

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Instituto de Assistência Médica ao Servidor Público Estadual
Study officials:
affiliation: HSPE
name: raquel teixeira, doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: pos graduatin student
name: Raquel Teixeira, doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06875986: REXULTI Drug General Use-results Survey (Excessive Motor Activity or Physically/Verbally Aggressive Behavior Due to Rapid Changes in Mood, Irritability, and/or Outbursts Associated With Dementia Due to Alzheimer's Disease)
Official title: REXULTI Drug General Use-results Survey (Excessive Motor Activity or Physically/Verbally Aggressive Behavior Due to Rapid Changes in Mood, Irritability, and/or Outbursts Associated With Dementia Due to Alzheimer's Disease)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Alzheimer Disease
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-03-14
Enrollment: 200
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in Japan who are planned to be newly started on Brexpiprazole OD tablets therapy for the excessive motor activity or physically/verbally aggressive behavior due to rapid changes in mood, irritability, and/or outbursts associated with dementia due to Alzheimer's disease

Brief summary: The purpose of this study is to evaluate safety of REXULTI in patients under daily clinical settings. In addition, information on efficacy will be collected.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with Alzheimer's disease

Exclusion Criteria:

-

Primary outcomes:
measure: Safety Information (Adverse Event)
timeFrame: 24 weeks from the initiation of brexpiprazole treatment
measure: Safety Information (Special Situations)
timeFrame: 24 weeks from the initiation of brexpiprazole treatment
measure: Safety Information (Number of off-Label Use)
timeFrame: 24 weeks from the initiation of brexpiprazole treatment
measure: Safety Information (Serious Adverse Event)
timeFrame: 24 weeks from the initiation of brexpiprazole treatment
measure: Safety Information (Non-serious Adverse Events)
timeFrame: 24 weeks from the initiation of brexpiprazole treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Osaka
country: Japan
facility: Pharmacovigilance Department
Study officials:
References:
Clinical trial NCT01444586: Russian Non-Interventional Study on Compliance of Venous Thromboembolism (VTE)
Official title: Prospective Multicentre Non-interventional Study on Compliance and Patient/Doctor Behavior of VTE Prevention in Major Orthopedic Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthroplasty, Replacement, Hip
Arthroplasty, Replacement, Knee
Keywords: non-interventional
Xarelto
knee replacement
hip replecement
Russia
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Janssen Research & Development, LLC
First posted: 2011-10-03
Enrollment: 2293
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients will be treated according to the routine practice. All the patients meeting the criteria of inclusion and exclusion to whom administration of Xarelto is indicated are fit for participation in this non-interventional study.

Brief summary: This is a local, prospective, multicenter, non-interventional, observational study. Primary objective is to describe how in "real life" thromboprophylaxis is carried out after the discharge from a hospital in the patients who undergo elective knee and hip replacement and who receive Xarelto during hospitalization.


Eligibility criteria: Inclusion Criteria:

* Male and female patients ≥ 18 years old
* Elective hip or knee replacement
* Planned VTE prevention with Xarelto
* Written informed consent
* The decision for treatment type and duration is taken by the investigator and is made before inclusion into the study.

Exclusion Criteria:

* Contraindications for the use of Xarelto in accordance with the effective instruction
* Any reasons of medical and non-medical character, which in the opinion of the physician can hamper participation of the patient in NIS, including a potentially low compliance, impossibility of making the final visit due to distant place of residence of the patient.

Primary outcomes:
measure: Real life out-patient thromboprophylaxis after arthroplasty: Share of patients who follow physician's prescriptions; true duration of out-patient thromboprophylaxis; duration of treatment interruptions; in case of switching - reasons, drug regimen.
timeFrame: Not more than 8 weeks
Secondary outcomes:
measure: Descriptive characteristics of prescription behaviour of orthopedists (VTE prevention recommended at discharge): continuation of rivaroxaban, switching to other products (name, dose, duration, efficacy control), mechanical prophylaxis, etc.
timeFrame: Not more than 8 weeks
measure: Adverse event characteristics (frequency, severity, relation to VTE prevention treatment, AE treatment, AE outcome)
timeFrame: Not more than 8 weeks
Other outcomes:
Locations:
city: Many locations
country: Russian Federation
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT06194786: Diet and Physical Activity Program in Colorectal Cancer Survivor: a Randomized Controlled Trial
Official title: Diet and Physical Activity Program in Colorectal Cancer Survivor: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Colorectal Cancer
Keywords: Diet
Physical activity
Lead sponsor: Habib Bourguiba University Hospital
Sponsor class: OTHER
Collaborators: name: National cancer institute -Misurata
First posted: 2024-01-08
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: Colorectal cancers (CRC) represent the 1st digestive cancer and the 3rd cancer in the world. The World Cancer Research Fund summarized evidence from observational studies and concluded that low dietary fiber, and high red and processed meat (RPM) intakes were associated with higher risk of (CRC), whilst physical activity (PA) protected against developing colon cancer.

Post-treatment management is essential for improving the health and quality of life of colorectal cancer (CRC) survivors. The number of cancer survivors is continually increasing, which is causing a corresponding growth in the need for effective post- treatment management programs. To date, there is insufficient information available from the published literature as to the most effective way in promoting lifestyle changes in CRC survivors. Moreover, none of these interventions have been conducted in an African population. We aim to assess whether the proposed program may effectively modify the targeted behaviors, to evaluate whether the dietary and PA interventions of the "Moving Bright, Eating Smart" program are effective in reducing the consumption of red and processed meat (RPM) and refined grain (RG), increasing the physical activity (PA) levels in north African (Libyan and Tunisian) adult colorectal cancer (CRC) survivors and to assess the efficacy of behavioral interventions on cancer outcomes (overall survival, disease free survival).


Eligibility criteria: Inclusion Criteria:

* Histologically proven colorectal adenocarcinoma patients above the age of 18 years within one year of completion of main cancer treatment who are able to provide informed consent.

Exclusion Criteria:

* Colorectal cancer patients who have persistent or recurrent disease at the time of the recruitment, are receiving cancer treatment, have known contraindication to physical activity, have psychiatric disease.

Primary outcomes:
measure: physical activity target-cancer outcome
timeFrame: 0-6-12-18-24 months
measure: Dietary target-red meat
timeFrame: 0-6-12-18-24 months
Secondary outcomes:
measure: overall survival
timeFrame: 12-2 months
measure: Disease free survival
timeFrame: 12-24 months
Other outcomes:
Locations:
city: Sfax
country: Tunisia
facility: Wala Ben Kridis
Study officials:
References:
Clinical trial NCT01525186: Observational Study of Parental Feeding Practices to Improve Child's Food Intake and Weight Status
Official title: The Relationship of Parental Feeding Control Practices to Food Intake of 3-5Yr Children in Families With Limited Incomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Feeding Behaviors
Keywords: Weight
Food intakes
Feeding
Lead sponsor: Michigan State University
Sponsor class: OTHER
First posted: 2012-02-02
Enrollment: 660
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Low income mother and preschool children participating national school readiness program, HeadStart.

Brief summary: Background:

A topic of interest in the etiology of child obesity is if and how parental feeding behaviors are associated with child food intake and weight status.

Objectives:

The objective was to explore if and how directive (overt) and non-directive (covert and food environmental structure) types of parental feeding control were associated with children's food intake and weight status.

Design:

This was a cross-sectional, exploratory study using structural equation modeling to determine directional associations between maternal feeding practices and their child's food intakes and weight status. Researchers collected data from 330 dyads of 3-5yr children and mothers participating in a federal preschool program for low-income families (Head Start) in Michigan. Mothers' feeding practices (directive and non-directive control), children's food intakes, height and weight of both mothers and children were measured. Structural equation models tested the relationships between maternal feeding practices, the child's food intake and weight status.

Hypotheses:

1. Child weight is negatively associated with parents' directive feeding control practices.
2. Less directive control or greater non-directive control is associated with healthier food intakes in children.


Eligibility criteria: Inclusion Criteria:

* Dyads of child (3-5yrs) and the primary female caregiver
* Participating Head Start program in central Michigan

Exclusion Criteria:

* Children with disability except speech disorders
* Caregivers younger than 18 years old

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Michigan State University
name: Sharon L Hoerr, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Murashima M, Hoerr SL, Hughes SO, Kaplowitz SA. Feeding behaviors of low-income mothers: directive control relates to a lower BMI in children, and a nondirective control relates to a healthier diet in preschoolers. Am J Clin Nutr. 2012 May;95(5):1031-7. doi: 10.3945/ajcn.111.024257. Epub 2012 Mar 28.
Clinical trial NCT01413386: Efficacy and Safety of the Paclitaxel Eluting Covered Biliary Stent to the Common Covered Metallic Biliary Stent
Official title: A Randomized Clinical Trial Comparing Patency and Safety of the Paclitaxel Eluting Covered Metallic Biliary Stent (Niti-S Mira-Cover II Biliary Stent) to the Common Covered Metallic Biliary Stent.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Biliary Stricture
Malignant Neoplasms
Keywords: paclitaxel
drug eluting stent
Lead sponsor: Taewoong Medical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2011-08-10
Enrollment: 74
Sex: ALL
Minimum age (years): 19
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Paclitaxel covered metal biliary stent is non-inferior to common covered metal biliary stent in their patency rate and safety at the 6 months after stenting.

Detailed description: Paclitaxel covered metal biliary stent (Niti-S Mira-Cover II Biliary Stent) is non-inferior to common covered metal biliary stent (Niti-S Biliary Stent_ComVi type)in their patency rate and safety at the 6 months after stenting.

Eligibility criteria: Inclusion Criteria:

* Patient who submitted a written informed consent for the this trial, and 18 \~ 90 years old
* Patient who have pancreatic cancer and/or biliary cancer with mid or distal CBD invasion
* Patient who is inoperable and/or unresectable cases of malignant pancreatic stenosis
* Patient who is attempting of endoscopic biliary metallic stenting (by ERBD) firstly
* Patient who have life expectancy at least longer than 3 months (Karnofsky score \>60%)

Exclusion Criteria:

* Patient who previously had surgical biliary drainage
* Patient who carrying bleeding disorder
* Patient who have combined Hilar and/or intra-hepatic duct cancer
* Patient who is improper to endoscopic treatment

Primary outcomes:
measure: Accumulative Patency Rate
timeFrame: 6 months
Secondary outcomes:
measure: Accumulative Survival Rate
timeFrame: 6 months
measure: Stent migration rate
timeFrame: 6 months
measure: Possibility of Other Treatment after Obstruction
timeFrame: 6 months
Other outcomes:
Locations:
city: Incheon
country: Korea, Republic of
facility: In Ha University Hospital
state: In Chun
city: Kangnam
country: Korea, Republic of
facility: Kangnam Severance Hospital
state: Seoul
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Kangnam Severance Hospital
name: Dong Ki Lee, Ph.D
role: STUDY_CHAIR
affiliation: Asan Medical Center
name: Mung Whan Kim, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Inha University Hospital
name: Don Haeng Lee, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: