louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04945590: The VIDA After COVID Study
Official title: Virtual Intervention and Direct Assessment (VIDA) of Social Determinants of Health in Southern Minnesota Latino Communities After Coronavirus Disease 2019 (COVID-19): a Pilot Study. the VIDA After COVID Study.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Covid19
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-06-30
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to objectively identify and address social determinants of health (SDOH) priorities and barriers in Latino patients who survived or are vulnerable to COVID-19, and to understand the consequences of COVID-19 survivorship in local Latino communities.


Eligibility criteria: Inclusion Criteria:

* Study population will be identified via community partnerships and peer referrals.
* Participants include Latino families in Southern Minnesota (Dover, Olmsted and Mower county, Minnesota) who survived COVID-19 after requiring ICU or hospital admission, and their families and/or their care partners, or Latino patients who are vulnerable to COVID-19, that have provided research authorization o identified via electronic health registries (following Institutional Review Board approved guidelines).

Exclusion Criteria:

* Families that do not identify as Latino.
* Those living outside Dover, Olmsted and Mower County, Minnesota.
* Those that do not provide written consent.

Primary outcomes:
measure: Social Determinants of Health (SDOH) Assessment Completed
timeFrame: Through study completion, approximately 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Mayo Clinic
name: Alice Gallo De Moraes, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00308490: Changes in Iron Markers Following Iron Loading in Hemodialysis Patients
Official title: Phase IV Study of Iron Indices' Kinetics in Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anemia in Chronic Renal Disease
Lead sponsor: Papageorgiou General Hospital
Sponsor class: OTHER
First posted: 2006-03-29
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to describe alterations of serum ferritin, transferrin saturation, soluble transferrin receptor, % hypochromic erythrocytes, % reticulocytes, reticulocyte hemoglobin content after iron loading in hemodialysis patients.


Eligibility criteria: Inclusion Criteria:

* hemodialysis for three months minimum
* stable epoetin dose for two months minimum
* serum ferritin concentration \< 1000 ng/ml
* transferrin saturation \< 50%
* parathormone concentration \< 800 pg/ml

Exclusion Criteria:

* hemoglobin concentration \> 13g/dl
* serum ferritin concentration \< 20 ng/ml
* vitamin B12 and/or folic deficiency
* other hematologic disease than anemia
* cancer
* hypothyroidism
* infectious disease

Primary outcomes:
measure: Ferritin alterations after iron loading at six and twelve weeks from the beginning of iron loading.
Secondary outcomes:
measure: All iron indices' alterations during twelve weeks from the beginning of iron loading.
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: Papageorgiou General Hospital
Study officials:
affiliation: Papageorgiou General Hospital
name: Efstathios Mitsopoulos, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03297190: Impact on Nutritional Practices: SMS and Interpersonal Communication
Official title: Evaluating the Impact of Text Messages and Interpersonal Community Support Groups on MICN Practices in Tanzania
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nutritional Deficiency
Lead sponsor: Helen Keller International
Sponsor class: OTHER
Collaborators: name: Tanzania Food and Nutrition Centre
First posted: 2017-09-29
Enrollment: 2245
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Four arms: (1) SMS only; (2) SMS + interpersonal; (3) interpersonal only; (4) none
Primary purpose: PREVENTION

Brief summary: This cluster randomized controlled study aims to add to the evidence base on mHealth interventions by assessing the main effects of delivering nutrition messages on key maternal, infant, and young child nutrition (MIYCN) behaviors and outcomes through three innovative behavior change strategies. The strategies compared will be: (i) an interpersonal communication strategy using the Tanzanian government's Mkoba wa Siku 1000 maternal, infant and young child nutrition (MIYCN) curriculum (MwS) through clinic- and community-based channels, (ii) the mNutrition SMS text messaging module of the government's Wazazi Nipendeni program, and (iii) the combination of both of these strategies (interpersonal and SMS messaging). They will be compared with the current standard of care in Tanzania. The goal will be to determine which has the greatest impact on key MIYCN and hygiene practices and care-seeking behaviors. It will be paired with a costing analysis so that these effects can be understood in the context of their costs.


Eligibility criteria: Inclusion Criteria:

* Mothers of children aged 0-12 mo. or pregnant at time of enrollment
* Consent to participate in the study

Exclusion Criteria:

* Unable to consent to participate in the study

Primary outcomes:
measure: Children's Dietary Diversity
timeFrame: 24 h
measure: Women's dietary diversity
timeFrame: 24 h
measure: Children's Minimum Meal Frequency
timeFrame: 24 h
Secondary outcomes:
Other outcomes:
Locations:
city: Dar es Salaam
country: Tanzania
facility: HKI-Tanzania
Study officials:
References:
Clinical trial NCT01612390: Comparison of Sublingual Misoprostol and Intravenous Oxytocin in Active Management of the Third Stage of Labor
Official title: Comparison of Sublingual Misoprostol and Intravenous Oxytocin in Active Management of the Third Stage of Labor
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Postpartum Hemorrhage Prevention by Using Oxytocin Verses Misoprostol
Keywords: postpartum hemorrhage
Lead sponsor: Ain Shams University
Sponsor class: OTHER
Collaborators: name: Ain Shams University
First posted: 2012-06-05
Enrollment: 180
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will include (180)randomly allocated

Brief summary: Sublingual misoprostol is superior to oxytocin in reduction of blood loss during the third and fourth stages of labor

Detailed description: Sublingual misoprostol is superior to oxytocin in reduction of blood loss during the third and fourth stages of labor as The data from a pharmacokinetics study suggested that the bioavaiblitiy of misoprostol after sub-lingual administration was higher than those after oral or vaginal administration

Eligibility criteria: Inclusion Criteria:

* Women with aheathy singleton pregnancy in spontaneous or induced labor at term .

Exclusion Criteria:

* Hypersensitivity/Contraindication to prostaglandins Antepartum hemorrhage Multiple pregnancy Cardiac disease Malpresentation Rhesus- negative mother hypersensitive disorders Severe anaemia(hemoglobin\<7g/dl)

Primary outcomes:
measure: reduce blood loss during third and fourth stages of labor.
timeFrame: 1 year
Secondary outcomes:
measure: the duration of the third stage of labor ,need for oxytocics ,blood transfusion and any adverse effects of the drugs
timeFrame: 1 year
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: AinShamsU
Study officials:
affiliation: Ain Shams University
name: RBadawi mohamed, M.B;B.CH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01538290: Validating Non-invasive Measurements of Central Blood Pressure in Type 2 Diabetic Patients
Official title: Validating Non-invasive Measurements of Central Blood Pressure in Type 2 Diabetic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 2
Blood Pressure
Keywords: Calibration
Validation
Transfer function
SphygmoCor
Arteriograph
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2012-02-24
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with type 2 diabetes mellitus referred to elective coronary angiography.

Brief summary: The investigators want to validate two non-invasive devices for the determination of central blood pressure, i.e. blood pressure in the aorta (artery leaving the heart).


Eligibility criteria: Inclusion Criteria:

* Diabetes Mellitus, Type 2
* Age above 18 years

Exclusion Criteria:

* Atrial fibrillation or other cardiac arrhythmia
* known stenosis of aorta or arteria subclavia/brachialis

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital, Skejby, Department of Cardiology
Study officials:
affiliation: Aarhus University Hospital, Skejby, Department of Cardiology
name: Hans Erik Bøtker, MD,Professor
role: STUDY_DIRECTOR
References:
citation: Laugesen E, Rossen NB, Peters CD, Maeng M, Ebbehoj E, Knudsen ST, Hansen KW, Botker HE, Poulsen PL. Assessment of central blood pressure in patients with type 2 diabetes: a comparison between SphygmoCor and invasively measured values. Am J Hypertens. 2014 Feb;27(2):169-76. doi: 10.1093/ajh/hpt195. Epub 2013 Dec 4.
citation: Rossen NB, Laugesen E, Peters CD, Ebbehoj E, Knudsen ST, Poulsen PL, Botker HE, Hansen KW. Invasive validation of arteriograph estimates of central blood pressure in patients with type 2 diabetes. Am J Hypertens. 2014 May;27(5):674-9. doi: 10.1093/ajh/hpt162. Epub 2013 Aug 31.
Clinical trial NCT03381690: Preoperative Epidural Labor Analgesia and Postoperative Pain
Official title: The Influence of Preoperative Epidural Labor Analgesia on Postoperative Pain in Parturients Undergoing Cesarean Section: a Retrospective Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cesarean Section
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2017-12-22
Enrollment: 222
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients underwent elective or emergent Cesarean section.

Brief summary: Parturients who undergo emergency Cesarean section (C-sec) after experiencing labor pain are likely to develop pain-induced central sensitization. The investigators hypothesized that those without epidural labor analgesia undergoing subsequent emergency C-sec would experience more severe postoperative pain or require more analgesia after C-sec compared to those with epidural labor analgesia. Thus, the investigators conducted this retrospective study by grouping parturients undergoing emergency C-sec after experiencing labor pain into two groups (epidural labor group and no epidural labor group) and those undergoing elective C-sec aimed to compare the effect of epidural labor analgesia on postoperative pain severity and analgesic consumption.


Eligibility criteria: Inclusion Criteria:

* Cesarean section(C-sec) under spinal anesthesia

Exclusion Criteria:

* Patients without accurate medical records
* Failure of epidural analgesia

Primary outcomes:
measure: The change of numerical rating scale for postoperative pain
timeFrame: At postoperative 6h, 24h, 48h, and 72h.
Secondary outcomes:
measure: The change of postoperative analgesic consumption
timeFrame: At postoperative 6h, 24h, 48h, and 72h.
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi
Study officials:
References:
Clinical trial NCT03687190: Could Tai-chi Help Maintain Balance of Spinocerebellar Ataxia Patients
Official title: Integrative Medicine and Tai-chi in Clinical Status of Spinocerebellar Ataxia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinocerebellar Ataxias
Tai Chi
Lead sponsor: Changhua Christian Hospital
Sponsor class: OTHER
First posted: 2018-09-27
Enrollment: 21
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Spinocerebellar atrophy is the most common autosomal dominant inherited ataxia. There are over thirty subtypes, which characterize neurologic features differently. They all have obvious substantial cerebellar atrophies in image, and unstable gait、ataxia. In general a prevalence of about three cases per 100 000 people is assumed, but this may be an underestimate. Progressive neurologic degeneration, in about 10-20 years, will leads to disability or wheelchair-dependent. Accompanying with fatigue, downhill course of the disease often made patients depressive and hopeless. The recent review of researches concludes no effective therapy for the disease. The purpose of the investigator's study is to explore the Tai-chi exercise effect for spinocerebellar ataxia.


Eligibility criteria: Inclusion Criteria:

* progressive ataxia accompanied with the observation of cerebellar atrophy on magnetic resonance or computed tomography images
* SARA score of less than 20

Exclusion Criteria:

* Patients with complicated cerebellar disorders, such as multiple system atrophy, Parkinson-plus syndromes, secondary cerebellar degeneration from encephalitis, trauma, hypoxia, cerebrovascular diseases, and toxic- or drug-induced cerebellar degeneration
* SARA score of larger than 20

Primary outcomes:
measure: Scale for the Assessment and Rating of Ataxia(SARA)
timeFrame: assessed at baseline and 9 months, 9 months reported as Outcome Measure Data
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Director of Chinese Medicine
name: Lun-Chien Lo
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05631990: A Study to Evaluate the Efficacy and Safety of AD-209
Official title: A Randomized, Double-Blind, Parallel, Multi-Center, Phase 2 Clinical Trial to Evaluate the Efficacy and Safety of AD-209 in Patients With Essential Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypertension, Essential
Lead sponsor: Addpharma Inc.
Sponsor class: INDUSTRY
First posted: 2022-11-30
Enrollment: 221
Sex: ALL
Minimum age (years): 19
Maximum age (years): 74
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 evaluate the efficacy and safety of AD-209

Detailed description: Condition or disease : hypertension Intervention/treatment Drug : AD-209 Drug : AD-209-1A Drug : AD-209-1B Drug : AD-209-1C Drug : AD-209 Placebo Drug : AD-209-1 Placebo Phase : Phase 2

Eligibility criteria: Inclusion Criteria:

* Signed informed consent
* Other inclusions applied

Exclusion Criteria:

* orthostatic hypotension with symptom
* Other exclusions applied

Primary outcomes:
measure: Change rate of MSSBP
timeFrame: Baseline, Week 8
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
Study officials:
affiliation: Korea University Guro Hospital
name: Chang Gyu Park, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02461290: Rituximab Therapy in Follicular Lymphoma in Combination With Chemotherapy - REFLECT 1
Official title: Open, Noninterventional, Multicentre Trial of Rituximab in Combination With Chemotherapy (CVP, CHOP or FCM) Chemotherapy in Patients With Follicular Lymphoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Follicular Lymphoma
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-06-03
Enrollment: 99
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with follicular lymphoma

Brief summary: The primary objective is to evaluate the safety profile and tolerability of rituximab in combination with different chemotherapy regimens.


Eligibility criteria: Inclusion Criteria:

* New diagnosed Stage III/IV NHLs
* Grades 1, 2 follicular lymphoma need to be treated
* mCD20 positive
* Have an expected survival of 3 months or more
* ECOG 0-2 grade
* Normal renal function
* ALT less than double normal level

Exclusion Criteria:

* Presence of CNS lymphoma
* Severe infectious disease or organic disease
* Having another malignant tumor
* Pregnant or breast-feeding female
* Organic heart disease, heart failure, II or higher grade AV bundle block.
* Subject is allergic to Rituximab
* Known HIV infection or chronic HBV infection

Primary outcomes:
measure: Number of Participants With an Adverse Event (AE), Serious AE, or Death Related to AE
timeFrame: Up to 3 years (at Screening, Baseline, end of induction therapy, and in accordance with routine practice)
Secondary outcomes:
measure: Percentage of Participants With Complete Remission (CR) or Partial Remission (PR) According to International Working Group Response Criteria for Non-Hodgkin's Lymphoma (NHL)
timeFrame: Up to 18 months (at Screening, Baseline, end of induction therapy, and in accordance with routine practice)
measure: Percentage of Participants With CR According to International Working Group Response Criteria for NHL
timeFrame: Up to 18 months (at Screening, Baseline, end of induction therapy, and in accordance with routine practice)
measure: Percentage of Participants Alive at 1, 2, and 3 Years
timeFrame: At 1, 2, and 3 years
Other outcomes:
Locations:
city: Belgrade
country: Serbia
city: Belgrade
country: Serbia
city: Kragujevac
country: Serbia
city: NIS
country: Serbia
city: Novi Sad
country: Serbia
city: Sremska Kamenica
country: Serbia
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT04256590: Tongue Depressor-related Tongue Swelling
Official title: Tongue Depressor-related Tongue Swelling in Adenoidectomy Surgeries in Pediatric Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Children, Only
Adenoidal Hypertrophy
Adenoid Disease - Chronic
Complication
Side Effect
Keywords: children
tongue disease
ultrasonography
enlarge tongue
adenoid
Lead sponsor: Selcuk University
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 67
Sex: ALL
Minimum age (years): 2
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients aged 16 years or younger who were to undergo adenoidectomy surgery were eligible for inclusion in this group. Informed consent was obtained from the parents of all the patients with a clinical diagnosis of chronic adenoiditis and adenoid hypertrophy (except tonsillectomy surgeries) and were to undergo adenoidectomy surgery.

Brief summary: This study aimed to detect tongue swelling induced by the pressure exerted by tongue depressor; swelling detection was made through tongue surface area measurement using ultrasonography (USG) in pediatric patients who underwent adenoidectomy surgeries.

Detailed description: The tongue is an ideal organ for ultrasonography (USG) evaluation. This study aimed to detect the occurrence of tongue swelling through USG examination and to educate clinicians about the association between subacute tongue swelling and tongue depressor in pediatric patients.

Eligibility criteria: Inclusion Criteria:

* Patients aged 16 years or younger
* Undergo adenoidectomy surgery
* Patients informed consent obtained from the parents

Inclusion Criteria for control group:

* Patients aged 16 years or younger
* Patients who did not need adenoidectomy surgery and any head and neck procedures
* Patients who underwent endotracheal intubation under general anesthesia except adenoidectomy and head and neck surgery.

Exclusion Criteria:

* Patients aged older than 16 years
* Patients with a history of syndromal craniofacial abnormalities
* Patients with systemic disorders and other otolaryngologic problems

Primary outcomes:
measure: Change from preoperative measurement to postoperative measurement in tongue surface area on the ultrasonography imaging.
timeFrame: 2018-2019 (6 months)
Secondary outcomes:
measure: Detection of swelling formation in tongue by using ultrasonography imaging.
timeFrame: 2018-2019 (6 months)
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Selcuk University
state: Selcuklu
Study officials:
affiliation: Selcuk University
name: Merih Onal
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05911490: Effects of Breaking Sitting on Human Behaviour and Metabolic Health
Official title: Effects of Breaking Prolonged Sitting on 24-h Human Behaviours, Self-feelings, Metabolic Health and Cognition in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Energy Balance
Physical Activity Level
Cognition
Metabolic Health
Keywords: Breaking up sitting
Eating behaviour
Spontaneous physical activity
Executive function
Energy balance
Lead sponsor: National Taiwan Normal University
Sponsor class: OTHER
Collaborators: name: Division of Endocrinology and Metabolism, Tri-Service General Hospital
First posted: 2023-06-22
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study primarily aimed to investigate effects of breaking up prolonged sitting with intermittent brisk walking in healthy young individuals on (1) post-trial human behaviours including energy intake and physical activity under free-living conditions and (2) cognitive performance in a simulated workplace environment.


Eligibility criteria: Inclusion Criteria:

* Without current and any history of brain injury, neurological disorder, cardiometabolic related diseases, diabetes or cancers.
* Weight stable (not self-reported weight change ± 3 kg at least 3 months)
* Body mass index (BMI) ranging between 18.5 to 27 kg/m2
* Can walk safely on a treadmill

Exclusion Criteria:

* Smokers, post-menopausal female, and volunteers who used any medications that could influence metabolic and inflammatory responses.

Primary outcomes:
measure: Physical activity level
timeFrame: 480 minutes
measure: Energy intake
timeFrame: 480 minutes
measure: Cognitive performance
timeFrame: 320 minutes
measure: Cognitive function
timeFrame: 320 minutes
Secondary outcomes:
measure: Postprandial glucose concentrations
timeFrame: 320 minutes
measure: Blood pressure
timeFrame: 320 minutes
measure: Visual analogue scale (VAS)
timeFrame: 320 minutes
measure: Continuous glucose monitoring
timeFrame: 320 minutes
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan Normal University
Study officials:
References: