louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01225263: Statin/Vitamin D & Migraine Study
Official title: Combined Statin and Vitamin D Therapy for Prophylactic Treatment of Episodic Migraine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Migraine
Keywords: Migraine disorders
Headache
Simvastatin
Vitamin D
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2010-10-20
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators are studying if taking simvastatin and vitamin D together will help prevent episodic migraines. Simvastatin is an FDA approved drug that is typically used to treat high cholesterol and reduce the risk of stroke and heart attack. Vitamin D is a vitamin found in certain foods like some types of fish, and in nutritional supplements. This study is 9 months long. Some people who participate will receive simvastatin and vitamin D, and some people will receive a placebo. A placebo is a "sugar pill" that looks like medication but does not have any active ingredients in it.

The investigators hypothesize that taking vitamin D and simvastatin daily may reduce the number of migraines people who have episodic migraine get.


Eligibility criteria: Inclusion Criteria:

* Age 18 years or older
* Have had migraines for at least 3 years
* Have between 4 and 15 migraines a month
* Able to speak and read the English language

Exclusion Criteria:

* Women who are pregnant or nursing, or planning on becoming pregnant in the next 10 months
* Individuals who have a had a heart attack, stroke, peripheral artery disease, atherosclerotic aortic disease, carotid artery disease, or diabetes
* individuals at high risk for cardiovascular disease

Primary outcomes:
measure: Migraine Frequency: Change From Baseline 12-week Period to Weeks 1 to 12
timeFrame: Weeks 1 to 12
measure: Migraine Frequency: Change From Baseline 12-week Period to Weeks 13 to 24
timeFrame: Weeks 13 to 24
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Catherine Buettner, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Beth Israel Deaconess Medical Center
name: Rami Burstein, PhD
role: STUDY_DIRECTOR
References:
citation: Buettner C, Nir RR, Bertisch SM, Bernstein C, Schain A, Mittleman MA, Burstein R. Simvastatin and vitamin D for migraine prevention: A randomized, controlled trial. Ann Neurol. 2015 Dec;78(6):970-81. doi: 10.1002/ana.24534. Epub 2015 Nov 13.
Clinical trial NCT02964663: Comparison of the Ability of the esCCO and the Volume View to Measure Trends in Cardiac Output During Cardiac Surgery
Official title: Comparison of the Ability of the esCCO and the Volume View to Measure Trends in Cardiac Output During Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Output, Low
Anesthesia
Lead sponsor: Université Libre de Bruxelles
Sponsor class: OTHER
First posted: 2016-11-16
Enrollment: 19
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: Patients scheduled for elective cardiac surgery

Brief summary: The purpose of this study was to compare CO measured by two easy to use non-invasive monitors, the esCCO (Nihon Kohden, Tokyo, Japan) to the Volume View (Edwards Lifesciences, Irvine, USA) and to assess their trending ability in patients undergoing cardiac surgery.

Detailed description: Cardiac output (CO) is a major physiological variable that should be monitored closely during cardiac surgery in order to assess and guide therapeutic interventions so as to decrease postoperative morbidity. The purpose of this study was to compare CO measured by two easy to use non-invasive monitors, the esCCO (Nihon Kohden, Tokyo, Japan) to the Volume View (Edwards Lifesciences, Irvine, USA) and to assess their trending ability in patients undergoing cardiac surgery. After Internal review board approval and written informed consent, 19 patients were included in this study. Before cardiopulmonary bypass (CPB), CO was measured simultaneously using both the esCCO and the Volume View device before and after 3 CO-modifying maneuvers \[passive leg raise (PLR), end expiratory occlusion test (EEOT) and positive end expiratory pressure (PEEP) at 10 cm H2O. Five CO values for esCCO and three for volume view were averaged and compared during a one minute period of time before and after each maneuver. The precision error and its 95% confidence interval (CI) that corresponds to the least significant change (LSC) were calculated within this period of time. The Bland-Altman analysis was used to compare bias, precision and limits of agreement (LOA) of both devices. Trending ability of CO changes was assessed by a modified 4 quadrant plot analysis, within angular limits of agreement considered as acceptable when the mean angle between both delta CO was less than 30°.

Eligibility criteria: Inclusion Criteria:

* patients scheduled for elective cardiac surgery

Exclusion Criteria:

* age less than 18 years
* known or potential pregnancy
* arrhythmias
* known significant tricuspid or aortic valve insufficiency
* left or right ventricular dysfunction
* peripheral arteriopathy
* low perfusion index.

Primary outcomes:
measure: interchangeability of both devices (esCCO vs VV)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Erasme Hospital
Study officials:
References:
Clinical trial NCT06258863: Investigating the Effects of Different Incision Types on Aesthetic Outcomes and Incision-related Complications After Breast Reconstruction Surgery
Official title: Investigating the Effects of Different Incision Types on Aesthetic Outcomes and Incision-related Complications After Breast Reconstruction Surgery
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Breast Neoplasm Female
Lead sponsor: Hubei Cancer Hospital
Sponsor class: OTHER
First posted: 2024-02-14
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: About 300 female patients who underwent breast reconstruction at Hubei Cancer Hospital between January 2019 and September 2023 were collected.

Brief summary: 1. DATA COLLECTION: About 300 cases of female patients who underwent breast reconstruction at Hubei Cancer Hospital(HBCH) between February 2013 and June 2023 were retrospectively collected. The incision was defined as the mastectomy incision and was grouped by the commonly used inframammary fold incision, lateral chest wall incision, circumareolar incision, and radial incision. The incidence of postoperative incision-related complications was recorded for different incision types;
2. DATA ORGANIZATION: Patients were divided into subgroups based on history of previous breast surgery, location and size of the lump, retention of the nipple-areola complex, timing of reconstruction, and type of the implant. The correlation of each subgroup with incision design is discussed;
3. FOLLOW-UP: Collected cases were followed up by telephone to complete the Breast-Q questionnaire (aesthetic score);
4. DATA ANALYSIS: The incidence of postoperative incision-related complications and aesthetic scores for different incision types were statistically analyzed.


Eligibility criteria: Inclusion Criteria:

1. total mastectomy
2. implant and/or autologous breast reconstruction.

Exclusion Criteria:

1. No total mastectomy
2. loss of data or loss of follow-up
3. fatal cases

Primary outcomes:
measure: Breast-Q Version 2.0 Reconstruction Module
timeFrame: three months after surgery; six months after surgery; 1 year after surgery
Secondary outcomes:
measure: Incision-Related Complications
timeFrame: within 1 year after surgery
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Hubei Cancer Hospital
state: Hongshan District
Study officials:
References:
Clinical trial NCT02124863: Influence of IPV on GOR in Infants From 0 to 12 Months.
Official title: Influence of Intrapulmonary Percussive Ventilation (IPV) on Gastro-oesophageal Reflux (GOR) in Infants From 0 to 12 Months.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastro-oesophageal Reflux
Lead sponsor: Vrije Universiteit Brussel
Sponsor class: OTHER
First posted: 2014-04-28
Enrollment: 67
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether Intrapulmonary Percussive Ventilation ( airway clearance technique) provokes or aggravates gastro-oesophageal reflux in infants from 0 to 12 months.


Eligibility criteria: Inclusion Criteria:

* infants from 0 to 12 months
* impedance monitoring

Exclusion Criteria:

* gestational age \< 24w
* anti-reflux medication
* Nissen fundoplication
* no parental consent

Primary outcomes:
measure: Number of Refluxes
timeFrame: during 20 minutes of IPV compared to mean number of refluxes during 20 minutes.
Secondary outcomes:
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: UZ Brussel
state: Brussels
Study officials:
affiliation: Vrije Universiteit Brussel
name: fili van ginderdeuren
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03927963: The Neuroprotection Effect of Dexmedetomidine
Official title: The Anti-inflammatory Effect and Hemodynamic Stability of Dexmedetomidine in Aneurysmal Clipping Operation; Compare With Propofol
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dexmedetomidine
Lead sponsor: Ajou University School of Medicine
Sponsor class: OTHER
First posted: 2019-04-25
Enrollment: 70
Sex: ALL
Minimum age (years): 19
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The brain protection effect of dexmedetomidine has been approved in several studies.

Basically, the anti-inflammatory effects and reducing catecholamines are thought to be a main role of the protection effect. In many studies reported the advantage of dexmedetomidine as a substitution of other sedative drugs for anesthesia.

The anesthesia of intra-cranial aneurysmal clipping operation commonly use intravenous anesthetic agents combined with inhalation anesthesia for neuroprotection, and mostly propofol is used.

The aim of this study is to examine the effects of dexmedetomidine on serum inflammatory markers and research the hemodynamic stability of dexmedetomidine compared to propofol in aneurysmal clipping operation.


Eligibility criteria: Inclusion Criteria:

* ASA class I,II patient needs operation of intracranial aneurysmal clipping without SAH

Exclusion Criteria:

* Any history of neurologic disease, dementia
* Allergic history of propofol or dexmedetomidine

Primary outcomes:
measure: The concentration of inflammatory markers
timeFrame: Baseline: Before injection study drugs
measure: The concentration of inflammatory markers
timeFrame: 1 minute after operation
measure: The concentration of inflammatory markers
timeFrame: Day 1 after operation
measure: The concentration of inflammatory markers
timeFrame: Day 2 after operation
measure: The concentration of norepinephrine
timeFrame: Baseline: Before injection study drugs
measure: The concentration of norepinephrine
timeFrame: 1 minute after operation
measure: The concentration of norepinephrine
timeFrame: Day 1 after operation
measure: The concentration of norepinephrine
timeFrame: Day 2 after operation
measure: The concentration of inflammatory markers
timeFrame: Baseline: Before injection study drugs
measure: The concentration of inflammatory markers
timeFrame: 1 minute after operation
measure: The concentration of inflammatory markers
timeFrame: Day 1 after operation
measure: The concentration of inflammatory markers
timeFrame: Day 2 after operation
Secondary outcomes:
measure: The frequency of hypotension or hypertension
timeFrame: during operation
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03264963: Upper Airway Training for Treatment of Snoring
Official title: Upper Airway Training for Treatment of Snoring Using Smartphone Application
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Snoring
Keywords: Upper airway exercises
Smart phone application
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: UMN Medical Devices Center
name: Fairview Sleep Center
First posted: 2017-08-29
Enrollment: 32
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to reduce the incidence or intensity of snoring in a patient population of known simple snorers without sleep apnea using smartphone based application which allows participants to play voice controlled games using various articulations resulting in tongue base movements.


Eligibility criteria: Inclusion Criteria:

1. Fluent in English.
2. Age is between 20 and 65.
3. BMI less than 32
4. Less than 5% variance in weight since sleep study.
5. Snoring without health risk related to sleep apnea and not currently receiving treatment.

   1. Mild OSA or negative HSAT or PSG within past year with AHI 0-14
   2. Has refused oral appliances, CPAP, weight loss, surgery or positional therapy.
6. Owns an iPhone 4 or newer and is comfortable downloading and using apps.
7. Complaint of habitual snoring 3 or more nights per week
8. Rated by polysomnograph technologist as moderate or loud snoring.

Exclusion Criteria:

1. Non-fluent in English.
2. Persistent rhinitis diagnosis or nasal obstruction.
3. BMI \> 32
4. Greater than 5% variance in weight since sleep study.
5. Diagnosis of moderate to severe sleep apnea or any other sleep disorder (insomnia, RLS)
6. Insufficient sleep, defined as getting fewer than 6 hours of sleep on an average night based on self report.
7. Spouse/partner is also a habitual snorer.
8. Lacking ability to consent for themselves.
9. Heavy drinker (self reported average more than 2 drinks per day).
10. Regular narcotics (greater than 3 times/week)
11. Epworth sleepiness scale score \> 11 or one near miss accident in the past 6 months.
12. Medical conditions as follows: symptomatic cardiopulmonary disease, chronic renal insufficiency, poorly controlled mental illness.

Primary outcomes:
measure: Snoring Intensity
timeFrame: 12 weeks
measure: Snoring Rate
timeFrame: 12 weeks
Secondary outcomes:
measure: Sleep Quality
timeFrame: 12 weeks
measure: Bed Partner Sleep Quality
timeFrame: 12 weeks
measure: Sleepiness
timeFrame: 12 weeks
Other outcomes:
Locations:
Study officials:
References:
citation: Goswami U, Black A, Krohn B, Meyers W, Iber C. Smartphone-based delivery of oropharyngeal exercises for treatment of snoring: a randomized controlled trial. Sleep Breath. 2019 Mar;23(1):243-250. doi: 10.1007/s11325-018-1690-y. Epub 2018 Jul 21.
Clinical trial NCT03419663: Systematic Review and Meta-analysis of Cereal or Grain Consumption and Gastric Cancer
Official title: Cereal or Grain Consumption and Gastric Cancer Risk: a Systematic Review and Meta-analysis of Observational Studies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastric Cancer
Keywords: cereal
whole grain
refined grain
gastric cancer
meta analysis
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2018-02-05
Enrollment: 11
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All individuals, both children and adults, regardless of health status

Brief summary: This project involved a systematic literature review of published trials of cereal or grain in relation to the risk of gastric cancer. Data was extracted from the publications on PubMed, EMBASE, Cochrane Library.A traditional meta-analysis, subgroup analysis, and heterogeneity was conducted on the extracted data.

Detailed description: Investigators searched PubMed, EMBASE, Cochrane Library for studies focusing on cereal or grain in relation to the risk of gastric cancer up to October 2017. Summary odd ratios (OR) and 95% confidence intervals (CI) were calculated by using either random effect models or fixed effect models according to the heterogeneity of included studies. Subgroup analysis, heterogeneity, and publication bias were also performed.

Eligibility criteria: Inclusion Criteria:

* a case-control studies or a cohort study
* investigate the association between cereal or grain intake and GC occurrence
* report an odds ratio (OR) or relative risk (RR) with corresponding 95% confidence intervals (CI)
* provide sufficient data to estimate OR or RR

Exclusion Criteria:

* Non-human studies
* GC mortality-based cohort studies

Primary outcomes:
measure: the relationship between overall cereal consumption and gastric cancer occurance
timeFrame: up to 2 years
Secondary outcomes:
measure: the relationship between whole grain and gastric cancer occurance
timeFrame: up to 2 years
measure: the relationship between refined grain and gastric cancer occurance
timeFrame: up to 2 years
measure: the relationship between other grain and gastric cancer occurance
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
Study officials:
References:
citation: Xu Y, Yang J, Du L, Li K, Zhou Y. Association of whole grain, refined grain, and cereal consumption with gastric cancer risk: A meta-analysis of observational studies. Food Sci Nutr. 2018 Nov 11;7(1):256-265. doi: 10.1002/fsn3.878. eCollection 2019 Jan.
Clinical trial NCT05273463: Comparing Perioperative Education Modalities for ACL Reconstruction on Patient Satisfaction, Self-Efficacy, and Surgical Outcomes
Official title: Comparison of Perioperative Education Modalities for ACL Reconstruction on Patient Satisfaction, Self-Efficacy, and Surgical Outcomes: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: ACL Injury
Anterior Cruciate Ligament Injuries
Keywords: ACL Reconstruction
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-03-10
Enrollment: 105
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this research is to find out whether the way information about surgery is presented to patients affects patient satisfaction, knowledge retention, and surgical outcomes such as anxiety


Eligibility criteria: Inclusion Criteria:

* Patients of Senior Attending orthopedic sports medicine surgeons at Mayo Clinic Arizona
* Patients with a proficiency in English in order to participate without need for translator.
* Patients with a diagnosis of a primary ACL injury in need of surgical reconstruction utilizing any surgical technique for ACL reconstruction.

Exclusion Criteria:

* Patients with a diagnosis of ACL injury in need of a surgical revision.
* Patients who have any multi-ligamentous injuries to the knee requiring modified postoperative unloading.
* Patients who have history of previous anterior cruciate ligament reconstructions in either leg.
* Patients who have either auditory or visual impairments.
* Patients who are medical professionals with work-related knowledge of ACL reconstruction.
* Patients with an inability or unwillingness of individual or legal guardian to give written informed consent.

Primary outcomes:
measure: Patient Satisfaction
timeFrame: 24 months
Secondary outcomes:
measure: Anxiety
timeFrame: 24 months
measure: Self-Efficacy
timeFrame: 24 months
measure: Kinesiophobia
timeFrame: 24 months
measure: Physical Function
timeFrame: 24 months
measure: Knowledge Retention
timeFrame: 24 months
measure: Pain Interference
timeFrame: 24 months
measure: History of Falls
timeFrame: 24 months
measure: Lysholm Knee Score
timeFrame: 24 months
measure: Activity Level
timeFrame: 24 months
measure: Confidence in Returning to Sport
timeFrame: 24 months
measure: Resilience
timeFrame: 24 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Hayley Powell, MSN, RN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06564363: The Efficacy of the IUrisure for Detection of Recurrent Urothelial Carcinoma
Official title: The Efficacy of the IUrisure for Detection of Recurrent Urothelial Carcinoma: a Single Center Prospective Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Urothelial Carcinoma
Keywords: Bladder cancer
Upper tract urothelial carcinomas
Recurrence
Methylation
Lead sponsor: Wuhan Ammunition Life-tech Co., Ltd
Sponsor class: INDUSTRY
First posted: 2024-08-21
Enrollment: 148
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: All urothelial carcinoma patients were not Ta stage or low-grade who met the indications for surgery. Surgical modalities include transurethral resection of bladder tumours (TURbt), partial cystectomy, radical nephroureterectomy, and kidney-sparing surgery. Urine samples were collected before and after surgery, and IUrisure methylation test was performed on each urine sample. The follow-up period was 24 months, and the patients underwent routine tests during the follow-up period. The gold standard for recurrence of urothelial carcinoma is surgical/biopsy pathology.

Brief summary: The clinical trial was designed to determine the efficacy (sensitivity and specificity) of the IUrisure test compared to the gold standard cystoscopy and pathology in patients under monitoring for recurrence of urothelial carcinoma.


Eligibility criteria: Inclusion Criteria:

1. Patients with high suspicion/confirmed urothelial carcinoma by CT, CTU, MR and other imaging examinations and meet the indications for surgery, including TURbt, partial cystectomy, radical nephroperectomy and kidney-sparing surgery;
2. Patients with highly suspected/confirmed recurrence of urothelial carcinoma who meet the indications for surgery, including TURbt, partial cystectomy, radical nephroperectomy and kidney-sparing surgery;
3. The patient agrees to participate in this study and has signed the informed consent form.

Exclusion Criteria:

* (1) Patients with urothelial carcinoma combined with other malignant tumors; (2) Patients with a history of other non-urothelial carcinoma cancers; (3) Samples that are not urothelial carcinoma in surgical pathology; (4) Samples of Ta/low-grade urothelial carcinoma shown by surgical pathology.

Primary outcomes:
measure: Specificity of IUrisure test
timeFrame: Day 1
measure: Sensitivity of IUrisure test
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
Study officials:
References: