louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05411029: Study of Disrupted Sleep in Somali Americans
Official title: Disrupted Sleep in Somali Americans - Implications for Hypertension Risk
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hypertension
Sleep Disorder
Healthy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2022-06-08
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The research team will partner with Somali operated community-based health clinics, faith-based establishments, community organizations, charter schools and other educational/community centers. In addition, the research team will partner with the Somali Health Advisory Committee (SHAC), a community advisory board based in Rochester and Minneapolis/St. Paul and the Somali Community Resettlement Agency (SCRS) and Somali American Social Services Association (SASSA), two community organizations aimed at integrating Somali immigrants to the United States.

Brief summary: The aims of this study are to determine the types and severity of previously undiagnosed sleep deficiencies in otherwise healthy Somali Americans, apply a research framework to define psychosocial, behavioral, environmental, and biological mechanisms mediating sleep deficiencies in Somali Americans, and examine the relationship between sleep deficiencies and increased blood pressure in Somali Americans.


Eligibility criteria: Inclusion Criteria:

* Subjects diagnosed with no known history of hypertension, diabetes, or sleep disorders.
* Self-identify as Somali.
* Adult males and females who are older than 18 years of age.

Exclusion Criteria:

* Anyone under 18 years or over 70 years.
* Positive pregnancy.

Primary outcomes:
measure: Undiagnosed sleep deficiency-short sleep
timeFrame: 1 night sleep study, approximately 8-9 hours
measure: Undiagnosed sleep deficiency-insomnia
timeFrame: 1 night sleep study, approximately 8-9 hours
measure: Undiagnosed sleep deficiency-obstructive sleep apnea (OSA)
timeFrame: 1 night sleep study, approximately 8-9 hours
measure: Disrupted sleep
timeFrame: 1 night sleep study, approximately 8-9 hours
measure: Blood pressure (BP) during wakefulness
timeFrame: Day 2
measure: Blood pressure (BP) during sleep
timeFrame: Day 2
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Virend Somers, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05703529: Group-based Positive Psychotherapy in Psychological Resilience of Only-Child-Lost People
Official title: The Impact of Group-based Positive Psychotherapy in Psychological Resilience of Only-child-lost People: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Resilience, Psychological
Bereavement
Mental Health
Lead sponsor: Central South University
Sponsor class: OTHER
First posted: 2023-01-30
Enrollment: 68
Sex: ALL
Minimum age (years): 49
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized controlled trial was conducted to evaluate the effectiveness of group-based positive psychotherapy on psychological resilience, depression, well-being, sleep quality, dehydroepiandrosterone in only-child-lost people. A total of 80 only-child-lost people who met the inclusion and exclusion criteria were expected to recruit. There were six weeks in the intervention, including positive introduction, positive reaction, gratitude, meaningful, three good things, and using personal strength. The measurements were conducted at the baseline, immediately after the intervention, 3-month after the intervention.


Eligibility criteria: Inclusion Criteria:

1. having only one child or legally adopting;
2. No surviving children;
3. basic language expression and comprehension skills;
4. the score of Connor-Davidson Resilience Scale is lower than 82

Exclusion Criteria:

1. in the acute bereavement period (\<6 months);
2. unable to participate in activities due to severe physical illness;
3. having diagnosis of sever mental illness;
4. receiving other psychological therapy.

Primary outcomes:
measure: Change of psychological resilience
timeFrame: Baseline, immediately after the intervention, 3-month after the intervention
Secondary outcomes:
measure: Change of depressive symptoms
timeFrame: Baseline, immediately after the intervention, 3-month after the intervention
measure: Change of index of well-being
timeFrame: Baseline, immediately after the intervention, 3-month after the intervention
measure: Change of Dehydroepiandrosterone (DHEA) in saliva
timeFrame: Baseline, immediately after the intervention, 3-month after the intervention
measure: Change of Sleep Quality
timeFrame: Baseline, immediately after the intervention, 3-month after the intervention
measure: Change of Social Avoidance and Social Distress
timeFrame: Baseline, immediately after the intervention, 3-month after the intervention
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02040129: Reduction of Corneal Astigmatism With Toric Intraocular Lens Implantation in Congenital Cataract
Official title: Reduction of Corneal Astigmatism With Toric Intraocular Lens Implantation : Early Results in Patients With Congenital Cataract
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congenital Cataract
Lead sponsor: Kyungpook National University Hospital
Sponsor class: OTHER
First posted: 2014-01-20
Enrollment: 4
Sex: ALL
Minimum age (years): 1
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study was conducted to evaluate changes of reduction of corneal astigmatism with toric intraocular lens(IOL) in congenital cataract.

Detailed description: This retrospective study included 6 eyes from 4 patients (mean age 7.2 years) with congenital cataract who had an astigmatism of 2.5 to 4.0 D prior to cataract surgery. Review of preoperative and postoperative visual acuity (UCVA), refraction, toric axis was performed.

Eligibility criteria: Inclusion Criteria:

* Children less than 14 years
* Congenital cataract at initial visit
* Symmetrical keratometric astigmatism more than 2.0 D

Exclusion Criteria:

* Microcornea (horizontal corneal diameter less than 9.5mm-asper that particular age)
* Corneal pathology
* Keratoconus
* Irregular astigmatism

Primary outcomes:
measure: Change from baseline in astigmatism after cataract surgery at 24 months
timeFrame: preop, 3,6,12,24 month postop
Secondary outcomes:
measure: Change from baseline in quality of vision after cataract surgery at 24 months.
timeFrame: preop, 3,6,12,24 months postop
Other outcomes:
Locations:
city: Daegu
country: Korea, Republic of
facility: Bo Young Chun, M.D.
state: Kyungsangpookdo
Study officials:
affiliation: Kyungpook National University Hospital
name: Bo Young Chun, M.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06275529: Evaluation of Transforaminal Epidural Steroid Injection in Radicular Low Back Pain According to MSU Classification
Official title: Evaluation of Pain and Oswestry Disability Index in Different Types of Disc Herniation According to MSU Classification in Patients Undergoing Transforaminal Epidural Steroid Injection for Radicular Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Radiculopathy Lumbar
Low Back Pain
Disc Herniation
Injections, Epidural
Lead sponsor: Başakşehir Çam & Sakura City Hospital
Sponsor class: OTHER_GOV
First posted: 2024-02-23
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Low back pain is a common disease in all ages and it effects seriously quality of life. Medical treatment,interventional methods and surgery are the treatment options. Transforaminal epidural steroid injections (TFSI) is one of the interventional method for radiculopathy with low back pain. Michigan State University(MSU) classification is a MRI based disc herniation classification. It helps to classified disc herniation in types, places and sizes.

The aim of this study to evaluate the pain and oswestry disability index in patients who have radiculopathy with low back pain, undergone TFSI according to MSU classification.


Eligibility criteria: Inclusion Criteria:

* between the ages of 18-65
* After outpatient evaluation, a decision was made to perform transforaminal steroid injection,
* Low back pain of more than 6 on a numeric rating scale (NRS)
* Radiculopathy for more than 4 weeks and less than one year and straight leg raising \<45
* Disc herniation at the L4-L5 or L5-S1 level on MRI
* Failure to respond to medical treatment for at least one month

Exclusion Criteria:

* Neurological deficit,
* Bleeding problems,
* Localized infection,
* Spinal pathologies (such as tumors),
* Fractures,
* Severe stenosis,
* Uncontrolled diabetes,
* Pregnancy,
* Red flag symptoms (such as motor and/or sphincter dysfunction)
* Patient reluctance,
* Computed tomography (CT) and MRI findings in favor of sequestrated fragments from herniated disc,
* Sphincteric disorders,
* Previous spine surgeries

Primary outcomes:
measure: Change of the pain severity score
timeFrame: Pre-intervention, post-intervention 1th month and post-intervention 3rd month
measure: Change of the disability score
timeFrame: Pre-intervention, post-intervention 1th month and post-intervention 3rd month
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Başakşehir Çam and Sakura City Hospital
Study officials:
affiliation: Başakşehir Çam & Sakura City Hospital
name: Tuba Tanyel Saraçoğlu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04121429: Stopping Cardiovascular Treatments and Mortality in a MICU
Official title: Impact on Mortality of Cardiovascular Treatments Interruption in a Medical Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Critical Care
Medication
Cardiovascular Diseases
Outcome, Fatal
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2019-10-09
Enrollment: 150
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Data will be extracted from the computerized medical datafile All patients with a medical history of cardiovascular disease and medication will be included within the time frame of the study All types of cardiovascular treatment will be considered: antiarrythmic drugs, anticoagulant and platelet aggregation inhibitors, vasodilators, inotropic drugs, antihypertensive agents, betablockers, statins

Brief summary: Cardiovascular treatments should not be interrupted following hospital admission, in order to decrease patients' morbidity. However, following ICU admission, such treatments are frequently interrupted and/or modified. The question of the study is to investigate wether such treatment interruption might be responsible for prognosis modifications.

Detailed description: Cardiovascular treatments should not be interrupted following hospital admission, in order to decrease patients' morbidity. However, following ICU admission, such treatments are frequently interrupted and/or modified.

Few studies have investigated the outcome impact of medications interruption and/or modifications following hospital admission. We did consider that it might be interesting to study whether treatment continuation, interruption, and/or re-introduction following ICU admission may modify patients' outcome either in the ICU or following hospital discharge (at 3,6 and 12 months).

Eligibility criteria: Inclusion Criteria:

* All patients with cardiovascular treatment prior to ICU admission

Exclusion Criteria:

* Data unavailability
* Consent withdrawal following information

Primary outcomes:
measure: ICU Mortality
timeFrame: 2 months following ICU Discharge
Secondary outcomes:
measure: Hospital mortality
timeFrame: 2 months following Hospital Discharge
measure: Mortality at Month 3 following discharge
timeFrame: 3-months following discharge
measure: Mortality at Month 6 following discharge
timeFrame: 6-months following discharge
measure: Mortality at Month 12 (1-year) following discharge
timeFrame: 12-months following discharge
Other outcomes:
Locations:
city: Brest
country: France
facility: Medical Intensive Care Unit, Brest University Hospital
Study officials:
References:
Clinical trial NCT00242229: Study Evaluating DVS-233 SR in Elderly Outpatients With Major Depressive Disorder
Official title: A 6 Month, Open-Label Evaluation of the Long-Term Safety of DVS-233 SR in Elderly Outpatients With Major Depressive Disorder (MDD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Keywords: Depression
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2005-10-19
Enrollment: 52
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: To evaluate the overall safety and tolerability profile of two dose levels of DVS-233 SR during 6 months of open-label treatment in elderly outpatients with major depressive disorder.


Eligibility criteria: Inclusion Criteria:

* Outpatients men and women aged 65 years or older.
* Mini Mental State Examination score of 24 or above.
* Subjects must have a primary diagnosis of MDD based on the criteria in the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV), single or recurrent episode, without psychotic features, on study day 1, if depressive symptoms for at least 30 days prior to screening visit and minimum screening and study day -1 (baseline) scores of 16 on the Hamilton Psychiatric Rating Scale for Depression (HAM-D17).

Exclusion Criteria:

* Significant risk of suicide based on clinical judgment, including common suicidal thoughts, and suicide being considered as a possible solution, even without specific plans or intention.
* Current (within 12 months of baseline) psychoactive substance abuse or dependence (including alcohol), manic episode, posttraumatic stress disorder, obsessive-compulsive disorder, or a lifetime diagnosis of bipolar or psychotic disorder as assessed by the modified Mini International Neuropsychiatric Interview (MINI). Current (within 12 months of baseline) generalized anxiety disorder, panic disorder, or social anxiety disorder as assessed by the modified MINI and considered by the investigator to be primary, causing a higher degree of distress or impairment than MDD. Presence (within 12 months of baseline) of a clinically important personality disorder (such as antisocial, schizotypal, histrionic, borderline, narcissistic). Presence of dementia.
* Depression associated with the presence of an organic mental disorder due to a general medical condition or a neurologic disorder.

Other exclusion applies.

Primary outcomes:
measure: To evaluate the long-term safety and tolerability of DVS SR in elderly outpatients with MDD.
Secondary outcomes:
measure: To evaluate the long-term response of subjects receiving DVS SR for the clinical global evaluation, functionality, general well-being, pain and absence of depressive symptoms (Hamilton Psychiatric Rating Scale for Depression 17-item score < or = 7).
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01037829: Novartis Pandemic Influenza A (H1N1) Vaccine(s) Observational Comparative Safety Study
Official title: A Post-Marketing, Observational, Comparative Safety Study of the Novartis Pandemic Influenza A (H1N1) Vaccine(s) in Pregnant Women Versus Non-Vaccinated Pregnant Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Influenza
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-12-23
Enrollment: 4529
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women

Brief summary: The primary objective of this observational, comparative safety study is to evaluate the safety of the Novartis Pandemic Influenza A (H1N1) vaccine in pregnant women and their off spring, followed for up to 3 months of age as compared to pregnant women who have not received the Novartis Pandemic Influenza A (H1N1) vaccine. This study will be conducted at investigative sites within the Netherlands, Italy, and Argentina.


Eligibility criteria: Inclusion Criteria:

* Currently pregnant OR was pregnant following the introduction of the Novartis Pandemic Influenza A (H1N1) vaccine in the country of interest and have already experienced a pregnancy outcome
* Consents to participate in the study

Exclusion Criteria:

* Is not currently pregnant OR was not pregnant at the time of or after the introduction of the Novartis Pandemic Influenza A (H1N1) vaccine in the country of interest
* Does not consent to participate in the study
* Has received a non-Novartis pandemic influenza vaccinee

Primary outcomes:
measure: Normal live-born delivery
timeFrame: 3 months follow-up on all live births
measure: Spontaneous and elective abortions
timeFrame: 3 months follow-up on all live births
measure: Congenital malformations
timeFrame: 3 months follow-up on all live births
measure: Pre-term birth (prematurity)
timeFrame: 3 months follow-up on all live births
measure: Low birth weight
timeFrame: 3 months follow-up on all live births
measure: Neonatal mortality
timeFrame: 3 months follow-up on all live births
Secondary outcomes:
measure: Maternal complications of gestational diabetes, preeclampsia, maternal death
timeFrame: During pregnancy and post delivery
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
city: Cordoba
country: Argentina
city: Villa Nueva de Guaymallen
country: Argentina
city: Bari
country: Italy
city: Cagliari
country: Italy
city: Como
country: Italy
city: Milano
country: Italy
city: Milano
country: Italy
city: Monza
country: Italy
city: Prato
country: Italy
city: Roma
country: Italy
city: Rome
country: Italy
city: Siena
country: Italy
city: Trieste
country: Italy
city: Udine
country: Italy
city: Vicenza
country: Italy
city: Ilsselstein
country: Netherlands
facility: Podiumweg
Study officials:
References:
Clinical trial NCT02340429: Using a Video Otoscope in Pediatric Ear Examination: A Prospective Randomized Controlled Study:
Official title: The Impact of Using a Video Otoscope on Parents' Satisfaction in Pediatric Ear Examination: A Prospective Randomized Controlled Study:
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parental Satisfaction of Using Video Otoscopy in Pediatric Emergency Room
Lead sponsor: Ziv Hospital
Sponsor class: OTHER_GOV
First posted: 2015-01-16
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Medical care today is moving towards patient centered care (PC) and patient empowerment (PE), both in practice and in medical staff training . Applying this methodology enhances patient autonomy in the clinical setting and allows shared decision making.

Current mobile and video technology enables the caregiver(clinician) to share visual data with the patient, making him or her a more active participant in the medical procedure. It has been shown that higher patient satisfaction rate regarding the patient/physician encounter, has a positive effect on medical procedure outcome and patient compliance.

Patient centered care and Patient Empowerment benefits are maximized using the proper tools. One such tool is the video otoscope. In this study we apply the PC/PE approach of medical care and introduce video otoscopy in the setting of a pediatric emergency room. We use an affordable (\~300$), FDA approved, High Res. video otoscope. (DE500 Digital Video Otoscope,Firefly global Inc.) Patients will be randomized upon admission into two groups: video otoscopy and standard otoscopy. Upon discharge from the pediatric ER, parents will be asked to answer a short questionnaire regarding their satisfaction with the ER visit and the otoscopic examination.

We aim to study the impact of affordable, high res. video otoscopy, on the general satisfaction of parents from their emergency room experience, vs their experience when undergoing a regular otoscopic examination.

Inclusion criteria: children under 18y admitted to the pediatric ER for any reason, undergoing routine otoscopy, who's parents have signed an informed consent.

Exclusion criteria: no parental informed consent,lake of compliance or inability to perform otoscopy.

Number of participants: 60 (30 in each group) Study start: January 2015 Study ends:January 2016 Study location: Ziv medical center, Zefat Israel


Eligibility criteria: Inclusion Criteria:

* Children under 18y admitted to the pediatric ER for any reason, undergoing routine otoscopy, who's parents have signed an informed consent.

Exclusion Criteria:

* no parental informed consent, lack of compliance or inability to perform otoscopy.

Primary outcomes:
measure: parental satisfaction questionnaire
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02876029: Food Design for Improved Day-long Glycaemic Regulation
Official title: The Effect on Glucose Tolerance at a Second Meal Provided After Breakfast Meal Giving Late Increment in Postprandial Glycaemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Poor Glycemic Control
Lead sponsor: Lund University
Sponsor class: OTHER
First posted: 2016-08-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The study focus is on the possible improvement in glucose tolerance at a second standardized meal that can be achieved when preceded by a test meal with a low GI and a high GP.

Detailed description: A study in healthy subjects using spaghetti as the test breakfast and a white wheat bread as the reference. Glycaemia, insulinaemia, NEFA, TG and subjective appetite are studied up to the time of the lunch meal that is served 4h after breakfast. After lunch the blood sampling continues for 2 hours.

Eligibility criteria: Inclusion Criteria:

* BMI 19-25

Exclusion Criteria:

* Smoker, Diabetes, Gluten intolerance, vegetarian

Primary outcomes:
measure: Glucose
timeFrame: 0-6 h
Secondary outcomes:
measure: Non-esterified fatty acids (NEFA)
timeFrame: 0-6 h
measure: Triglycerides (TG)
timeFrame: 0-6 h
measure: Appetite rating (Visual Analogue Scale)
timeFrame: 0-6 h
measure: Insulin
timeFrame: 0-6 h
Other outcomes:
Locations:
Study officials:
affiliation: Food for Health Science Centre (Medicon Village) - Lund University
name: Elin Östman, Ass prof
role: STUDY_DIRECTOR
References: