louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06968611: Improving Patient-centered Care for Diabetes in Bangladesh Through "Dynamic Integration" of Vision Care on the Demand Side
Official title: Improving Patient-centered Care for Diabetes in Bangladesh Through "Dynamic Integration" of Vision Care on the Demand Side
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Diabetes Mellitus
Diabetic Retinopathy (DR)
Lead sponsor: Orbis
Sponsor class: OTHER
Collaborators: name: District Diabetes Hospital, Dinajpur district of Bangladesh
name: Gausul Azam BNSB Eye Hospital, Dinajpur district of Bangladesh
First posted: 2025-05-13
Enrollment: 569
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this clinical trial is to review if there is an increase in participant uptake of diabetes mellitus (DM) and diabetic retinopathy (DR) services and improve the quality of patient-centered diabetic care through the use of automated voice message reminders to sensitize people with DM about the potential for sight loss alongside the provision of free reading glasses.

The main questions it aims to answer are:

1. Will the proportion of patients defaulting on their scheduled DR and DM appointments be significantly reduced in the group receiving the automated voice messages compared with participants not receiving the messages?
2. What is the cost-effectiveness, measured as total intervention cost per additional patient complying with the suggested exam.

Researchers will compare the number of participants that received automated voice messages that completed their diabetes or DR exam within 3 weeks of the scheduled date to participants that did not receive the messages.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with DM within the last 6 months
* Diagnosed with high-risk DR
* Over 30 years of age
* Currently treated at the Dinajpur Diabetes Hospital
* Possess a mobile phone to receive voice messages
* Willingness to participate in the study

Exclusion Criteria:

* Other significant causes of vision loss
* Medical conditions that could impair compliance with follow-up (such as stroke, dementia, etc.)
* Do not possess a mobile phone to receive voice messages
* Not willing to participate in the study

Primary outcomes:
measure: Proportion of patients completing their diabetes or DR exam within 3 weeks of the scheduled date.
timeFrame: 3 weeks following scheduled exam date
Secondary outcomes:
measure: Cost-effectiveness, measured as total intervention cost per additional patient adherence with the suggested exam.
timeFrame: Enrollment to 3 weeks following suggested exam date
Other outcomes:
Locations:
city: Dinajpur Sadar
country: Bangladesh
facility: Dinajpur Diabetes & Swasthoseba Hospital
city: Dinajpur
country: Bangladesh
facility: Gausul Azam BNSB Eye Hospital
Study officials:
affiliation: Orbis Bangladesh
name: Munir Ahmed
role: PRINCIPAL_INVESTIGATOR
affiliation: Orbis
name: Nathan Congdon
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00186511: Expanding Rural Access: Distance Delivery of Support
Official title: Expanding Rural Access: Distance Delivery of Support
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Stress Disorders, Post-Traumatic
Depression
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: University of California, Berkeley
First posted: 2005-09-16
Enrollment: 40
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The major goal of this project is to test the feasibility and acceptability of using videoconferencing to provide support groups led by trained facilitators to rural women with breast cancer in northern California.

Detailed description: Women with breast cancer in rural areas are likely exhaust their usual sources of psychosocial support while still facing challenges posed by breast cancer, but are unlikely to have access to professionally-led support groups. In this community-based project, we assessed the feasibility and acceptability of providing support groups to women with breast cancer in a large rural area using videoconferencing and a workbook journal, and we assessed the intervention's potential to reduce distress and increase emotional expression and self-efficacy for coping with cancer. Twenty-seven women in the Intermountain Region of northeastern California participated in 8-session support groups led by an oncology social worker by going to nearby videoconferencing sites. Feasibility and acceptability were demonstrated. Older as well as younger women were comfortable using videoconferencing and said the groups were valuable because they promoted information sharing and emotional bonds with other women with breast cancer. They emphasized the importance of a professional facilitator and identified advantages of using videoconferencing for support groups. Pretest and posttest comparisons showed significant decreases in depression and posttraumatic stress disorder symptoms. The results suggest that the intervention has the potential to provide a valuable service that is not readily available in rural communities.

Eligibility criteria: Inclusion Criteria:

* 1) has been diagnosed with breast cancer, and 2) is a woman

Exclusion Criteria:

* 1) under 21 years of age, and 2) does not speak and read English

Primary outcomes:
measure: Center for Epidemiological Studies Depression Scale
measure: Posttraumatic Stress Checklist
Secondary outcomes:
measure: Cancer Behavior Inventory
measure: Courtauld Emotional Control Scale
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Cheryl Koopman, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06622811: Effect of Educational Program of Virtual Reality on Critical Thinking Disposition Among Nursing Students at Damietta University
Official title: Effect of Educational Program of Virtual Reality on Critical Thinking Disposition Among Nursing Students at Damietta University
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Educational Program
Virtual Reality
Critical Thinking
Nursing Students
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2024-10-02
Enrollment: 190
Sex: ALL
Minimum age (years): 21
Maximum age (years): 22
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The present study aims to evaluate the effect of an educational program of virtual reality on critical thinking disposition among nursing students at Damietta University.

Detailed description: Education is the basis for a thriving society, and the transfer of knowledge has been a top priority for civilization since the very beginning, in all the world people are constantly looking for more easily, more quickly, and more effective in a world where technology is a dominant feature in our daily life.

Virtual reality in the field of medical and nursing education is defined as a type of computer-based 3D simulation that makes users feel like they are in clinical settings where they can practice skills without putting patients at risk. Therefore, such simulations with active engagement improve learning retention and enable participants to learn interactively and analyze problems.

Critical thinking disposition is one of the skills that need to be developed in the current era. Critical thinking skills can be defined as a student's ability to test their idea in dealing with problems the art of analyzing and evaluating thinking, deducting and inferring conclusions from problems and facts.

Eligibility criteria: Inclusion Criteria:

* Age from 21 to 22 years.
* Both sexes.
* Nursing students.

Exclusion Criteria:

- Mental retardation

Primary outcomes:
measure: Students' Knowledge about Virtual Reality Questionnaire
timeFrame: Two months after educational program
Secondary outcomes:
measure: Students' Knowledge about Virtual Reality Questionnaire
timeFrame: Two months after educational program
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University
state: Dakahlia
Study officials:
References:
Clinical trial NCT04740411: Online Wellness Intervention for College Students
Official title: An Online Wellness Intervention for American College Students: Investigating the Efficacy of The Common Elements Toolbox
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Anxiety
Well-being
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Indiana University
name: Ohio State University
name: University of Missouri, St. Louis
First posted: 2021-02-05
Enrollment: 850
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: We are evaluating the effects of an online single-session mental health intervention (the Common Elements Toolbox; COMET). To evaluate COMET, we are conducting a randomized controlled trial with college students attending American universities. Students will be randomized to the COMET condition or to a wait-list control condition.


Eligibility criteria: Inclusion Criteria:

* At least 18 years old and a student at a participating university. Access to the internet.

Exclusion Criteria:

* Cannot have participated in a previous version of COMET.

Primary outcomes:
measure: Change in the Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Up to 8 weeks post-intervention
measure: Change in the Generalized Anxiety Disorder Screener-7 (GAD-7)
timeFrame: Up to 8 weeks post-intervention
measure: Change in the Short Warwick-Edinburgh Mental Well-being Scale
timeFrame: Up to 8 weeks post-intervention
measure: Change in items from the PERMA Profiler (positive emotion and negative emotion subscales).
timeFrame: Up to 8 weeks post-intervention
Secondary outcomes:
measure: Ratings on the Acceptability of Intervention Measure (AIM)
timeFrame: Immediately after the intervention
measure: Ability to Cope with COVID-19
timeFrame: Up to 8 weeks post-intervention
measure: Change in Secondary Control
timeFrame: Up to 8 weeks post-intervention
measure: Change in the Positive and Negative Affect Schedule
timeFrame: Up to 8 weeks post-intervention
measure: Perceived Utility Ratings
timeFrame: Immediately after the intervention
measure: Change in the Perceived Stress Scale-4
timeFrame: Up to 8 weeks post-intervention
measure: Change in the Gratitude Adjective Checklist
timeFrame: Up to 8 weeks post-intervention
measure: Change in the Self-kindness subscale of the Self-Compassion Scale
timeFrame: Up to 8 weeks post-intervention
measure: Change in Cognitive Restructuring
timeFrame: Up to 8 weeks post-intervention
measure: Change in items from the Behavioral Activation for Depression Scale
timeFrame: Up to 8 weeks post-intervention
measure: Beck Hopelessness Scale
timeFrame: Up to 8 weeks post-intervention
measure: Change in module-specific skills
timeFrame: Up to 8 weeks post-intervention
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
References:
Clinical trial NCT02917811: Red Cell Distribution Width (RDW) as a Prognostic Marker in ICU
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blood Transfusion
Biochemical Marker
Lead sponsor: Università degli Studi di Ferrara
Sponsor class: OTHER
First posted: 2016-09-28
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients admitted to ICU will be considered for the study

Brief summary: The aim of this study is to verify if high values of RDW are useful prognostic marker for ICU mortality and 90-days mortality. Moreover, we will investigate the prognostic value of RDW in specific subgroup population with some clinical characteristic wich may modify RDW baseline values, i.e. transfused patients or patients with high markers of hemolysis


Eligibility criteria: Inclusion Criteria:

* Unselected ICU patients

Exclusion Criteria:

* Length of stay in ICU \<48 hours
* Hematological disease
* Age \<18 years

Primary outcomes:
measure: 90-days mortality
timeFrame: 90 days
Secondary outcomes:
measure: ICU mortality
timeFrame: 90 days
measure: Length of mechanical ventilation
timeFrame: 90 days
Other outcomes:
Locations:
city: Ferrara
country: Italy
facility: Sant'Anna Hospital
Study officials:
References:
citation: Kim CH, Park JT, Kim EJ, Han JH, Han JS, Choi JY, Han SH, Yoo TH, Kim YS, Kang SW, Oh HJ. An increase in red blood cell distribution width from baseline predicts mortality in patients with severe sepsis or septic shock. Crit Care. 2013 Dec 9;17(6):R282. doi: 10.1186/cc13145.
citation: Lorente L, Martin MM, Abreu-Gonzalez P, Sole-Violan J, Ferreres J, Labarta L, Diaz C, Gonzalez O, Garcia D, Jimenez A, Borreguero-Leon JM. Red blood cell distribution width during the first week is associated with severity and mortality in septic patients. PLoS One. 2014 Aug 25;9(8):e105436. doi: 10.1371/journal.pone.0105436. eCollection 2014.
Clinical trial NCT03297411: Clinical Outcomes With Electroconvulsive Therapy: Insights From Computational Modelling
Official title: Clinical Outcomes With Electroconvulsive Therapy: Insights From Computational Modelling
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Depression
Keywords: electroconvulsive therapy
computer modelling
Lead sponsor: The University of New South Wales
Sponsor class: OTHER
Collaborators: name: Wesley Mission
First posted: 2017-09-29
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Each participant will be randomly allocated to a sequence of treatments using designs for crossover studies with fewer periods (3) than treatments (4) involving two sets of ECT electrode placements and two sets of pulse width.
Primary purpose: TREATMENT

Brief summary: This study will generate new information on how to optimise brain targets with ECT stimulation.

Detailed description: This study will differentiate the brain regions which are related to the effectiveness of electroconvulsive therapy (ECT) as a treatment, from the brain regions associated with memory impairment, with ECT stimulation. This will be done by 1) testing effects on memory of 4 different forms of ECT, which stimulate the brain differently; 2) in a subset of participants, use computer modelling to assess the pattern of brain stimulation with the 4 forms of ECT, and match these results to memory outcomes.

Eligibility criteria: Inclusion Criteria:

* Aged ≥18 years; right-handed
* DSM-5 Major Depressive Episode
* Prescribed with a course of ECT

Exclusion Criteria:

* Diagnosis (as defined by DSM-V) of psychotic disorder (apart from Major Depressive Episode with Psychotic features), current drug or alcohol abuse or dependence;
* ECT treatments in last 3 months from a prior course of ECT;
* Score \<23 on the Montreal Cognitive Assessment Battery (MoCA);
* Past or current neurological illness or injury, medical illness which may significantly affect neuropsychological function;
* Inability to give informed consent or comply with study procedures; or
* Not having worked or studied in an English speaking background (to ensure validity of neuropsychological testing).
* Not be claustrophobic (if having an MRI brain scan).
* Not have any metal in your head or body (if having an MRI brain scan).
* Likely non response to RUL forms of ECT, as indicated by past non response to RUL ECT

Primary outcomes:
measure: HVLT-R
timeFrame: Approximately 30 min after ECT treatment
measure: BVMT-R
timeFrame: Approximately 30 min after ECT treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Wesley Hospital Kogarah
state: New South Wales
Study officials:
affiliation: The University of New South Wales
name: Colleen Loo, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03677011: Andrositol® TEST as Diagnostic Assay to Predict the Fertilization Potential in IVF
Official title: Andrositol® TEST as Diagnostic Assay to Predict the Fertilization Potential of the Sperm in the in Vitro Fertilization (IVF) Procedures.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Male Infertility
Keywords: myo-inositol
fertilization rate
infertility
Intracytoplasmic Sperm Injection
sperm
Lead sponsor: Lo.Li.Pharma s.r.l
Sponsor class: INDUSTRY
First posted: 2018-09-19
Enrollment: 249
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Andrositol® test allows to obtain additional information besides the WHO parameters and to evaluate the semen energetic status. The diagnosis is performed by analyzing the semen at two different time points: before the treatment and 30' after the addiction of myo-inositol directly to the semen. The purpose of this study is to evaluate if the responsiveness to the Andrositol® test of a sperm sample can be predictive of its fertilization rate in an ICSI (Intracytoplasmic Sperm Injection) cycle (primary outcome). Secondary outcomes as embryo development, embryo euploidy status and embryo implantation rate will be evaluated.


Eligibility criteria: Inclusion Criteria:

* male partners of couples undergoing an egg donor cycles

Exclusion Criteria:

* sperm volume lower than 1 ml
* sperm count lower than 5 X 106 /ml
* total sperm motility lower than 10%

Primary outcomes:
measure: increment of the fertilization rate
timeFrame: up to 20 hours after ICSI
Secondary outcomes:
measure: Increment of implantation rate
timeFrame: up to 10 days after ICSI
measure: embryo development
timeFrame: up to 6 days after ICSI
measure: embryo euploidy
timeFrame: from 10 days after ICSI
Other outcomes:
Locations:
city: Pasadena
country: United States
facility: HRC Pasadena
state: California
Study officials:
affiliation: HRC Pasadena 333 S Arroyo Pkwy Fl 3 Pasadena, CA 91105
name: Tih T. Tan, Ms
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04603911: RCT Comparing ESPB Solutions in Breast Surgery
Official title: An Investigator-Initiated, Double-Blind, Patient-Controlled, Randomized Control Trial Comparing the Effectiveness of Liposomal Bupivacaine to a Solution of Bupivacaine, Epinephrine Clonidine and Dexamethasone in Bilateral, Single Shot, Erector Spinae Plane Blocks During Oncoplastic Breast Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: bilateral breast surgery
Lead sponsor: Tufts Medical Center
Sponsor class: OTHER
First posted: 2020-10-27
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The object of our research is to investigate the relative efficacy of liposomal bupivacaine administered via an Erector Spinae Plane (ESP) block as compared to our standard of care medication solution of (bupivacaine mixed with epinephrine, dexamethasone, and clonidine) for pain management in subjects undergoing bilateral surgical intervention for breast cancer. This will be an investigator-initiated, double-blind, patient-controlled, randomized control trial comparing pain scores at 48 hours after injection.


Eligibility criteria: Inclusion Criteria:

1. Adults 18 to 75 years of age at screening
2. Scheduled to undergo oncoplastic bilateral mastectomy and reconstruction surgery at Tufts Medical Center

Exclusion Criteria:

1. Adults unable to consent (inability to read, write, or has some impairment that hampers consent process or documentation, or cognitively impaired adults)
2. Pregnant women
3. Pregnant minors
4. Woman of childbearing potential who are unwilling or unable to complete a pregnancy test
5. Minors i.e., individuals who are not yet adults (neonates, children, teenagers)
6. Wards of the state
7. Non-viable neonates
8. Neonates of uncertain viability
9. Prisoners
10. Adults with known allergy, hypersensitivity, intolerance or contraindication to study medication

Primary outcomes:
measure: Pain Score at 48 hours
timeFrame: 48 hours
Secondary outcomes:
measure: Pain Scores at 6, 12, 18, 24, 30, 38, 42, and 72 hours
timeFrame: 72 hours
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
Study officials:
References:
Clinical trial NCT05101811: Vitamin D Levels in Women With Polycystic Ovary Syndrome
Official title: Assessment of Serum Vitamin D Levels in Women With Polycystic Ovary Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Polycystic Ovary Syndrome
Lead sponsor: Ghamra Military Hospital
Sponsor class: OTHER
Collaborators: name: Al-Azhar University
First posted: 2021-11-01
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel study
Primary purpose: DIAGNOSTIC

Brief summary: Polycystic ovary syndrome is the commonest endocrinopathy among women of reproductive age. Its worldwide prevalence has been estimated between5-10%.

Vitamin D, a fat-soluble vitamin, can be produced in two ways: by intestinal absorption and endogenous synthesis from a precursor of 17-hydroxyl cholesterol on the skin with sufficient exposure to ultraviolet sunlight.

Detailed description: The aim of this work is assessment of the level of vitamin D in female have polycystic ovary syndrome \& healthy female.and also make diagnostic criteria for patient who is in need for supplementations with vitamin D.

Eligibility criteria: Inclusion criteria:

* Hyperandrogenism
* Polycystic ovary syndrome

Exclusion Criteria:

* Thyroid disease
* Parathyroid disease
* Diabetes Mellitus
* Cushing syndrome
* Congenital adrenal hyperplasia
* Hyperprolactinemia
* Renal, liver or chronic disease

Primary outcomes:
measure: Levels of vitamin D in Polycystic ovary syndrome
timeFrame: 1 year
Secondary outcomes:
measure: Levels of vitamin D in fertile women
timeFrame: 1 year
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Misr Al Gadida Military hospital
Study officials:
affiliation: Ghamra Military Hospital
name: Osama Mohamed
role: PRINCIPAL_INVESTIGATOR
References: