louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05557123: Mobile App for Improving Adherence of Rivoxaban (RIVOX-AF)
Official title: The ReInforcement of Adherence Via Self-monitoring App Orchestrating Biosignals and Medication of RivoXaban in Patients with Atrial Fibrillation and Co-morbidities: Randomised Control Study(RIVOX-AF Study)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Atrial Fibrillation
Keywords: atrial fibrillation
mobile app
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
Collaborators: name: SAMJIN PHARM
First posted: 2022-09-27
Enrollment: 1042
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: RIVOX-AF study is a prospective, multicenter, randomized controlled study in which patients with AF are allocated to medication-app group or conventional treatment group. The App based feed-back algorithm will provide the patients with check taking drug or reminding of taking drug.


Eligibility criteria: Inclusion Criteria:

* Patients with AF aged 19 years or older with one or more comorbidities including heart failure, myocardial infarction, stable angina, hypertension or diabetes mellitus (Patients can be enrolled 3 months after myocardial infarction or percutaneous coronary intervention).
* patients who already took or plan to take rivoxban
* patients who able to use smart phone

Exclusion Criteria:

* creatinine clearance \<15ml/min
* moderate or severe mitral stenosis
* mitral valve operation history
* current alcohol abuse or alcohol abus history
* Not eligible for study due to legal or psychiatric problem
* enrolled other clinical study within 4 weeks
* declined to enroll the study

Primary outcomes:
measure: Drug adherence
timeFrame: 24 week
measure: Proportion of adequate medication adherence at 24 weeks
timeFrame: 24 weeks
Secondary outcomes:
measure: The occurrence of clinical composite end point
timeFrame: 24 week
measure: The occurrence of MACCE and hospitalization
timeFrame: 24 week
measure: The occurrence of Thromboembolism (Stroke, TIA, Pulmonary embolism)
timeFrame: 24 week
measure: The occurrence of bleeding
timeFrame: 24 week
measure: Drug adherence
timeFrame: 12 week
measure: Proportion of adequate medication adherence at 12 weeks
timeFrame: 12 week
measure: medication adherence by zero-inflated model
timeFrame: 12 week and 24 weeks
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
Study officials:
affiliation: Seoul National Univeristy Bundang Hospital
name: Dong-Ju Choi, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT06818123: Exploring the Effectiveness of Interventions on Menstrual Hygiene Awareness in Slum Communities of Karachi, A Quasi- Experimental Analysis
Official title: Exploring the Effectiveness of Interventions on Menstrual Hygiene Awareness in Slum Communities of Karachi, A Quasi- Experimental Analysis.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Menstruations
Menstruation Hygiene
Hygiene Practices and Knowledge
Knowledge Gaps
Social Stigma
Keywords: Hygiene Practice
Slums Area
Knowledge and practices
Knowledge Gaps
Poor Hygiene
Menstruation Hygiene
Lead sponsor: SINA Health Education and Welfare Trust
Sponsor class: OTHER
First posted: 2025-02-10
Enrollment: 400
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Proper menstrual hygiene knowledge and practices are crucial among women. People of urban slum's areas have no or less knowledge and practices of Menstruation hygiene due to low socio-economic status. This study helps in Improving menstrual hygiene knowledge and practices and can empower individuals to manage their periods with dignity and comfort. This study also contributes in creating a more open and supportive environment for menstruation by addressing stigma and misconception. The study also helps in reducing the risk of reproductive tract infections.


Eligibility criteria: Inclusion Criteria:

* Woman age in between 15-45years of age
* Those who used reusable items for menstruations
* Those who are willing to participate voluntarily will be included in the study

Exclusion Criteria:

* Participants who are suffering from any serious medical condition.
* live in other than slums area of Karachi will be excluded from the study.

Primary outcomes:
measure: Improved Menstruations Hygiene knowledge
timeFrame: one month
Secondary outcomes:
measure: Reduction in vaginal infection
timeFrame: one month
measure: promoting better self-esteem and confidence
timeFrame: one month
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: SINA Health Education and Welfare Trust
state: Sindh
Study officials:
References:
Clinical trial NCT02116023: The Effects of Processed Whole Orange on Subjective Ratings of Satiety
Official title: The Effect of Different Doses of Processed Whole Orange on Subjective Ratings of Satiety
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Self Reported Ratings of Hunger
Keywords: Satiety, beverage, crossover
Lead sponsor: PepsiCo Global R&D
Sponsor class: INDUSTRY
First posted: 2014-04-16
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The study is a human dietary test meal study that is a randomized, controlled, double blind, cross over design with 3 intervention arms that will investigate the subjective ratings of satiety in response to different levels of processed whole orange compared with a sugar-matched isocaloric control


Eligibility criteria: Inclusion Criteria:

* Gender: male or female
* Age at start of the study: males and females ≥ 21and ≤ 65 years
* Females taking contraceptive pill or post menopausal
* Body Mass Index (BMI) ≥ 18.5 and ≤ 27 kg/m2
* Apparently healthy: measured by questionnaire, no reported current or previous -metabolic diseases or chronic gastrointestinal disorders
* Reported dietary habits: no medically prescribed diet, no slimming diet within the past 3 months, used to eating 3 meals a day
* Reported intense sporting activities ≤ 10h/w
* Reported alcohol consumption ≤21 units/w Informed consent signed
* Recruitment form filled out

Exclusion Criteria:

* Smoking
* Premenopausal females not taking the contraceptive pill
* Dislike, allergy or intolerance to test products
* Possible eating disorder (measured by SCOFF questionnaire score \>1)
* Eating habits questionnaire score \>14
* Reported medical treatment that may affect eating habits/satiety
* Food allergies or intolerance

Primary outcomes:
measure: Self reported ratings of hunger and fullness
timeFrame: 0-2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Reading
country: United Kingdom
facility: University of Reading
Study officials:
References:
Clinical trial NCT02014350: Outcomes Following Delta Xtend Reverse Shoulder System
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Reverse Total Shoulder Arthroplasty
Lead sponsor: Rothman Institute Orthopaedics
Sponsor class: OTHER
First posted: 2013-12-18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: patients who were implanted with the DePuy Delta Xtend Reverse Total Shoulder Arthoplasty between 2008-2012

Brief summary: To collect medium to long-term survivorship implant outcomes on the DePuy Delta Xtend Reverse Shoulder Stystem.


Eligibility criteria: Inclusion Criteria:

Patients whom were implanted with the DePuy Delta Xtend Reverse Total Shoulder System in the time frame indicated. Patients must be willing to sign the consent form and complete all follow-up visits.

Primary outcomes:
measure: Implant Survivorship
timeFrame: 10 years post-operative
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Rothman Institute
state: Pennsylvania
Study officials:
References:
Clinical trial NCT04921150: Standardized Management of Complex Twins
Official title: Standardized Management of Complex Twins
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Twins
Lead sponsor: Shengjing Hospital
Sponsor class: OTHER
Collaborators: name: Shengjing Hospital
First posted: 2021-06-10
Enrollment: 100
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: At present, the incidence of monochorionic twins in all pregnancies is around 3-5‰ worldwide.In 2019, the twin Committee of China Maternal and Child Health Association conducted statistics from 48 medical units all over the country, showing that there were 4,876 cases of monochorionic twins, accounting for 10.2‰ of all pregnancies.In addition to increased incidence of preterm delivery, miscarriage, and maternal complication, the unique placental vascular structure of monochorionic twins is associated with complex fetal complication such as twin-twin transfusion syndrome, selective intraurine growth restriction, twin anaemia-erythrocytosis sequence, twin reversed arterial perfusion sequence, one of twin with dysplasia, twins with single amniotic sac and conjunctions are common. At present, there is no unified standard for the diagnosis and treatment of these complicated twins, and various treatment methods have a great impact on the pregnancy outcome and fetal prognosis.Therefore, the standardized management of complex twins benefits diagnosis and treatment of complex twins and improves fetal prognosis.


Eligibility criteria: Inclusion Criteria:

complex twin disease 18-45 years

Exclusion Criteria:

single pregnancy normal twin pregnancy

Primary outcomes:
measure: Standardized management system of twin pregnancy clinic
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05072223: Ultrasound-guided PENG Block for Shoulder Surgery
Official title: Efficacy and Safety of Pericapsular Nerve Group (PENG) Block for Patients Undergoing Shoulder Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain After Shoulder Surgery
Lead sponsor: Henan Provincial People's Hospital
Sponsor class: OTHER
First posted: 2021-10-08
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Significant pain after shoulder surgery induce worse experience and may delay recovery of patients undergoing shoulder surgery. Interscalene brachial plexus block (ISB) is a common and rapid-onset procedure for pain control of patients undergoing shoulder surgery. However, the high incidence of adverse events such as hemidiaphragmatic paresis, horner syndrome after interscalene block threatened patients' safety and raised clinicians' concerns on them. Hence, effective analgesia alternatives to interscalene block with less complications are needed.

Recently, pericapsular Nerve Group (PENG) Block, a new technology is reported for block of articular branches of the shoulder and well pericapsular spread around the glenohumeral joint. In this study, we assume that PENG Block may offer a noinferior analgesia and less incidence of nerve block related adverse events compared with ISB.


Eligibility criteria: Inclusion Criteria:

* ASA I-III
* 18 years and older
* Shoulder surgery

Exclusion Criteria:

* Severe pulmonary diseas
* Chronic pain disorders
* Infection of shouler skin
* Pregnant women
* Patients allergy to local anesthetics

Primary outcomes:
measure: Postoperative pain scores
timeFrame: 3 month
Secondary outcomes:
measure: Adverse events
timeFrame: 3 month
Other outcomes:
Locations:
Study officials:
References:
citation: Yamak Altinpulluk E, Teles AS, Galluccio F, Simon DG, Olea MS, Salazar C, Fajardo Perez M. Pericapsular nerve group block for postoperative shoulder pain: A cadaveric radiological evaluation. J Clin Anesth. 2020 Dec;67:110058. doi: 10.1016/j.jclinane.2020.110058. Epub 2020 Sep 26. No abstract available.
citation: Yamak Altinpulluk E, Galluccio F, Salazar C, Olea MS, Garcia Simon D, Espinoza K, Teles AS, Gonzalez-Arnay E, Fajardo Perez M. A novel technique to Axillary Circumflex Nerve Block: Fajardo approach. J Clin Anesth. 2020 Apr 16;64:109826. doi: 10.1016/j.jclinane.2020.109826. Online ahead of print. No abstract available.
citation: Kupeli I, Yazici Kara M. Anesthesia or analgesia? New block for shoulder surgery: pericapsular nerve group block. Braz J Anesthesiol. 2022 Sep-Oct;72(5):669-672. doi: 10.1016/j.bjane.2021.05.009. Epub 2021 Jun 9.
citation: Lee MG, Shin YJ, You HS, Lim CH, Chang YJ, Shin HJ. A Comparison of Anesthetic Quality Between Interscalene Block and Superior Trunk Block for Arthroscopic Shoulder Surgery: A Randomized Controlled Trial. Pain Physician. 2021 May;24(3):235-242.
Clinical trial NCT06017050: BullyDown, a Text Messaging-based Bullying Prevention Program for Middle School-aged Youth
Official title: Developing a Bullying Prevention Program That Transcends Physical Boundaries
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bullying
Lead sponsor: Center for Innovative Public Health Research
Sponsor class: OTHER
Collaborators: name: University of North Carolina, Chapel Hill
First posted: 2023-08-30
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Youth will be randomized to either the intervention or control group.
Primary purpose: PREVENTION

Brief summary: Given the limited impact of existing school-based interventions and the time associated with implementing them during school time, more efficient and effective intervention methods are needed. Programs that can be delivered to middle school youth irrespective of whether they are attending school physically or virtually may be especially relevant as school boundaries become more fluid. BullyDown addresses this critical need by providing a scalable program that could be quickly and cost-effectively disseminated nationally.


Eligibility criteria: Inclusion Criteria:

* 7th or 8th grade
* English speaking
* Own their own cell phone
* Home internet
* Provide informed assent

Exclusion Criteria:

* Non-English speakers
* Unable to read the screener
* Know someone else in the RCT
* Know they are not on an unlimited text messaging plan

Primary outcomes:
measure: Feasibility of the intervention
timeFrame: Through study completion, anticipated to be 1 year
measure: Acceptability of the intervention
timeFrame: Intervention end, 8 weeks after program enrollment
Secondary outcomes:
Other outcomes:
measure: Relatively lower rates of bullying perpetration in the intervention versus control group
timeFrame: In the past 30 days at 3-months post-randomzied controlled trial (RCT) end
measure: Relatively lower rates of aggressive behavior in the intervention versus control group
timeFrame: In the past 30 days at 3-months post-RCT end
measure: Relatively higher rates of bystanding behavior in the intervention versus control group
timeFrame: In the past 30 days at 3-months post-RCT end
Locations:
city: San Clemente
country: United States
facility: Center for Innovative Public Health Research
state: California
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
References:
Clinical trial NCT06566950: BFR Training on Muscle Morphology
Official title: Effectiveness of Blood Flow Restriction Training on Muscle Morphology and Prevention of Patellofemoral Pain Syndrome and Anterior Cruciate Ligament Injury
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Blood Flow Restriction Training
Eccentric Training
Muscle Morphology
Patellofemoral Pain Syndrome
Anterior Cruciate Ligament Injuries
Lead sponsor: Udayana University
Sponsor class: OTHER
First posted: 2024-08-22
Enrollment: 75
Sex: ALL
Minimum age (years): 15
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This randomized clinical trial study compares high-load eccentric training (HL-Et), sham LL-BFRt, and low-load blood flow restriction (LL-BFRt) in sportsmen. The primary inquiries it seeks to address are:

Is LL-BFR superior to HL-Et and sham LL-BFRt in terms of improving muscle morphology? Is LL-BFR a more effective Patellofemoral Pain Syndrome and ACL injury preventive than HL-Et and sham LL-BFRt?

The three intervention groups that will be randomly assigned to participants are LL-BFRt, sham LL-BFRt, and HL-Et. Participants are expected to carry out:

Participants in LL-BFRt will be required to perform LL eccentric training at 30% of their repetition maximum (RM) and 70% of their artery occlusion pressure (AOP). This training will include stairs, single leg squat, and single leg deadlift.

Participants in HL-Et will be required to perform LL eccentric training at 70% of their maximum number of repetitions (RM).

In order to determine whether muscular morphology and the prevention of Patellofemoral Pain Syndrome and ACL injury improve following the interventions and follow-up, researchers will compare LL-BFRt, sham LL-BFRt, and HL-Et.


Eligibility criteria: Inclusion Criteria:

* Being between the ages of 15 and 35
* Play level 1 sports (fight martial arts, basketball, futsal, and soccer) at least twice a week
* Never experienced an Patellofemoral Pain Syndrome or ACL injury before
* Never experienced a grade III sprain or strain
* Consent to participate in the study until its conclusion and provide informed consent.

Exclusion Criteria:

* Having a tumor, cancer, vena thromboembolic disease, obesity, diabetes, hypertension, anemia, and renal failure
* Disabilities or those who are disabled.

Primary outcomes:
measure: Muscle cross-sectional area
timeFrame: 8 weeks
measure: Vastus medial obliques fiber angle
timeFrame: 8 weeks
measure: Patella position
timeFrame: 8 weeks
Secondary outcomes:
measure: Incidence of patellofemoral pain syndrome
timeFrame: 1 year
measure: Incidence of anterior cruciate ligament injury
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06084923: Outcomes of Unfit Patients With CLL Included in the GIMEMA LLC1114 Trial Who Discontinued Ibrutinib Due to Reasons Other Than Disease Progression
Official title: Outcomes of Unfit Patients With Chronic Lymphocytic Leukemia (CLL) Included in the Front-line GIMEMA LLC1114 Trial Who Discontinued Ibrutinib Due to Reasons Other Than Disease Progression: a Multicenter Retrospective/ Prospective Observational Study.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Chronic Lymphocytic Leukemia
Lead sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto
Sponsor class: OTHER
First posted: 2023-10-16
Enrollment: 73
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: CLL patients enrolled in the front-line GIMEMA LLC1114 study who discontinued ibrutinib due to reasons other than CLL progression, Richter syndrome, malignancy or death, or lost to the follow-up.

Brief summary: The goal of this observational study is to assess in the cohort of CLL patients enrolled in the front-line GIMEMA LLC1114 study who discontinued ibrutinib the time to subsequent treatment. The main question it aims to answer is:

• The 12 and 24-month TTNT measured from the time of ibrutinib discontinuation due to reasons other than CLL progression, Richter syndrome, malignancy or death, or lost to the follow-up.

Participants will be observed for the duration of the study.

Detailed description: This is an observational, multicenter, retrospective and prospective study aimed at analyzing in the cohort of CLL patients enrolled in the front-line GIMEMA LLC1114 study the time to next treatment in patients who discontinued ibrutinib due to reasons other than CLL progression, Richter syndrome, malignancy or death, or lost to the follow-up.

Eligibility criteria: Inclusion Criteria:

* Patients treated with ibrutinib included in the LLC1114 GIMEMA study who have discontinued ibrutinib after completing 78-months of treatment per protocol OR patients treated with ibrutinib included in the LLC1114 GIMEMA study who were treated for at least 12 months before discontinuing ibrutinib due to reasons other than CLL progression, Richter syndrome, malignancy or death, or lost to the follow-up and had achieved a response (CR or PR/PR-L) lasting at least 6 months before discontinuing ibrutinib
* Informed consent, if applicable.

Exclusion Criteria:

- Patients with concomitant conditions that may interfere with an appropriate assessment of the TTNT in the physician opinion.

Primary outcomes:
measure: The 12 and 24-month Time To Next Treatment (TTNT) measured from the time of ibrutinib discontinuation due to reasons other than CLL progression, Richter syndrome, malignancy or death, or lost to the follow-up.
timeFrame: 12 and 24 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Roma La Sapienza
name: Francresca Romana Mauro
role: PRINCIPAL_INVESTIGATOR
References: