louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05782140: ALgorithms Adapted From Remote Monitoring
Official title: ALgorithms Adapted From Remote Monitoring
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Surgery
Keywords: Remote Monitoring
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2023-03-23
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: NON_PROBABILITY_SAMPLE
Study population: Subjects undergoing surgery in the Mayo Clinic Rochester Department of Surgery.

Brief summary: Through the aid of remote monitoring and early symptom detection, a patient's response to stress and normalization to their individual baseline can better contribute towards algorithms which are predictive of clinical decline.


Eligibility criteria: Inclusion Criteria:

* 18 years and older
* Scheduled to undergo surgery resulting in a complex recovery as evaluated by the treating Department of Surgery surgeon. This includes but is not limited to the following inpatient elective surgery procedures: esophagectomy, pancreatectomy, major liver resections, open vascular surgery, lower extremity bypass, colectomy, and complex pulmonary resections (lobes and above).
* Subjects are committed to daily exercise as outlined in the protocol.

Exclusion Criteria:

* \<18 years of age
* Subject is pregnant
* Subject is dismissed from the hospital to a nursing home or long term care facility.
* Subject cannot commitment to daily exercise as outlined in the protocol.
* Subjects enrolled in another device or drug study does not necessarily preclude them from participating in this study. Please check with the PI for inclusion if the subject is on another device or drug study.

Primary outcomes:
measure: Rate of Compliance of Remote Monitoring
timeFrame: Pre-operative to 15 days post discharge.
Secondary outcomes:
measure: Correlation of Compensatory Reserve Algorithm
timeFrame: Pre-operative to 15 days post discharge.
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Janani Reisenauer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02642640: Interaction of Melatonin and MTNR1B Genotype on Glucose Control - Study 1
Official title: Interaction of Melatonin and MTNR1B Genotype on Glucose Control - Study 1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glucose
Circadian Rhythm
Melatonin
Genes
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2015-12-30
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This project aims to test the impact of melatonin and MTNR1B variation on regulation glucose regulation in a highly controlled in-laboratory setting and ex vivo in pancreatic islets.

Detailed description: The investigators' recent GWAS discovery of MTNR1B as a novel type 2 diabetes gene has sparked great interest into the role of melatonin in glycemic control, for which the mechanism is largely unknown. This research will determine the effect of melatonin and MTNR1B on glycemic control under highly-controlled, in-laboratory protocols while manipulating circulating melatonin concentrations (both up and down) and assessing glycemic control by frequently-sampled intravenous glucose tolerance tests, as well as in ex vivo human pancreatic islets. This research will provide mechanistic insights into the metabolic effects of melatonin and the MTNR1B risk variant and may help in evidence-based approaches and personalized recommendations to improve glycemic control in night shift workers and late-night eaters.

Eligibility criteria: Inclusion Criteria:

* Body Mass Index: 20 and 35 kg/m2
* Age: 21-55 years of age
* Caucasian
* Non-smoking
* With regular sleep-wake cycle
* Passed medical and psychological screening tests

Exclusion Criteria:

* Acute, chronic or debilitating medical conditions
* History of neurological or psychiatric disorder
* History of sleep disorder or regular use of sleep-promoting medication
* Current prescription, herbal, or over-the-counter medication use
* Traveling across 2 or more time zones within past 3 months
* Worked night or rotating shift work within past 1 year
* Drug or alcohol dependency

Primary outcomes:
measure: change in disposition index
timeFrame: Day 2 and/or 4 of the in-lab protocol
Secondary outcomes:
measure: change in first-phase insulin release
timeFrame: Day 2, 3, 4 and/or 5 of the in-lab protocol
measure: change in insulin sensitivity
timeFrame: Day 2, 3, 4 and/or 5 of the in-lab protocol
measure: change in glucose tolerance
timeFrame: Day 2, 3, 4 and/or 5 of the in-lab protocol
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Frank AJL Scheer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05922540: a Cohort Study of Ischemic Cerebrovascular Disease
Official title: a Prospective, Multicenter Cohort Study of Ischemic Cerebrovascular Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ischaemic Stroke
Lead sponsor: Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2023-06-28
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Continuously enroll hospitalized patients who meet the inclusion criteria

Brief summary: This study aims to establish a multicenter, large-scale, prospective cohort of patients with ischemic stroke. Various biological samples such as blood, feces, and urine are collected to identify biomarkers associated with ischemic stroke. By integrating demographic information, clinical indicators, imaging parameters, and biomarker parameters, the study aims to develop risk assessment, early warning, and prognosis prediction models. Additionally, the study aims to identify key genes and explore relevant signaling pathways related to ischemic stroke.


Eligibility criteria: Inclusion Criteria:

1. Clinical diagnosis of ischemic stroke.
2. Age ≥ 18 years.
3. Signed informed consent form.

Exclusion Criteria:

1. Patients with moderate to severe mental disorders or dementia who cannot cooperate to complete the informed consent and follow-up procedures.
2. Patients with neurological functional impairment caused by conditions such as migraine aura, epilepsy, or other non-ischemic strokes.
3. Agitated patients who cannot cooperate with imaging examinations.
4. Pregnant or lactating patients, as well as those planning to become pregnant within 90 days.
5. Patients with concurrent malignant tumors or severe systemic diseases with an expected survival period of less than 90 days.
6. Patients who have participated in other clinical studies within 30 days prior to enrollment or are currently participating in other interventional clinical studies.

Primary outcomes:
measure: Cerebrovascular events
timeFrame: 3 months of onset in patients
measure: mRS scores
timeFrame: 3 months of onset in patients
Secondary outcomes:
Other outcomes:
Locations:
city: Hunan
country: China
facility: Xiangya Hospital, Central South University
Study officials:
References:
Clinical trial NCT02536040: Stopping Cavities Study: Diammine Silver Fluoride
Official title: Pragmatic Trial of Topical Diammine Silver Fluoride for Dental Caries Arrest
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dental Caries
Keywords: silver diamine fluoride
diammine silver fluoride
children
Lead sponsor: Advantage Dental Services, LLC
Sponsor class: INDUSTRY
First posted: 2015-08-31
Enrollment: 66
Sex: ALL
Minimum age (years): 24
Maximum age (years): 60
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is being conducted to test whether the use of diammine silver fluoride (also called silver diamine fluoride) hardens the cavity sufficiently so that it arrests.

Detailed description: Phase III RCT with two arms: (1) 38% diammine silver fluoride; (2) distilled fluoride free water. Subjects are 200 preschool children in good general health with untreated tooth decay. Intervention is topical application of the study drug to the open cavity. Primary outcome is caries activity at 14-21 days.

Eligibility criteria: Inclusion Criteria:

* Nyvad criteria 3
* Active carious lesion

Exclusion Criteria:

* Allergy to silver
* Stomatitis or oral ulcerative condition
* Weight less than 15 kg

Primary outcomes:
measure: Dental Caries Activity
timeFrame: 14-21 days
Secondary outcomes:
Other outcomes:
Locations:
city: Redmond
country: United States
facility: Advantage Dental Plans
state: Oregon
Study officials:
affiliation: Advantage Dental Plans
name: Peter Milgrom, DDS
role: STUDY_DIRECTOR
References:
Clinical trial NCT06147440: Different Dietary Patterns
Official title: Different Dietary Patterns: Investigations in Healthy Participants
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diet, Healthy
Endotoxemia
Lead sponsor: University of Vienna
Sponsor class: OTHER
First posted: 2023-11-27
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of the present study is to determine the effects of different standardized dietary patterns on general health markers, intestinal function, immune response and affective processes/ cognitive skills in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* BMI between 18.5 kg/m² und 24.9 kg/m²

Exclusion Criteria:

* Chronic inflammatory diseases
* Metabolic diseases
* Viral or bacterial infections in the last 3 weeks
* Allergic reactions in the last 3 weeks
* Intake of anti-inflammatory drugs
* Malignant diseases
* Pregnancy and lactation
* Smoking
* Alcohol consumption \> 10 g/d for women and \> 20 g/d for men
* Drug consumption
* Vegetarian or vegan diet
* Food intolerances

Primary outcomes:
measure: Changes in parameters of intestinal barrier function
timeFrame: 1 week
Secondary outcomes:
measure: Changes in parameters of immune response
timeFrame: 1 week
measure: Changes in blood lipid levels
timeFrame: 1 week
measure: Changes in cognitive skills
timeFrame: 1 week
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: University of Vienna
Study officials:
References:
Clinical trial NCT02948140: Evaluation of New Diagnostic Methods of Cardio-embolic Related (Atrial Fibrillation) Cerebral Infarction
Official title: Evaluation of New Diagnostic Methods of Cardio-embolic Related (Atrial Fibrillation) Cerebral Infarction
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Stroke
Keywords: Subdiaphragmatic infarction
Lead sponsor: Hopital Foch
Sponsor class: OTHER
First posted: 2016-10-28
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of the study is to estimate the contribution of abdominal imaging by magnetic resonance Imaging (MRI) and abdominal scanner in the detection of subdiaphragmatic infarction associated to the atrial fibrillation in the cerebral infarction.


Eligibility criteria: Inclusion Criteria:

* Patient over 18
* Patient having a CHADS-VAsc Score ≥ 2;
* Patient hospitalized for a secondary established ischemic accident in an atrial fibrillation not anticoagulated (INR\<2 and/or receiving antiplatelet (aspirin, clopidogrel)) for less than 14 days;
* Patient affiliated to a national insurance scheme or beneficiary
* Patient having given a written consent

Exclusion Criteria:

* Patient presenting cognitive disorders incompatible with the planned examinations (MRI / SCANNER).
* Pacemaker or implantable defibrillator, or other contraindication in the MRI (metallic eye brightness, intra cerebral clip).
* Contraindication in injected scanner.
* Current pregnancy

Primary outcomes:
measure: Number of patients with subdiaphragmatic infarctions detected by abdominal MRI
timeFrame: 14 days
Secondary outcomes:
measure: Number of patients with subdiaphragmatic infarctions detected by abdominal scanner
timeFrame: 14 days
Other outcomes:
Locations:
city: Suresnes
country: France
facility: Hôpital Foch
Study officials:
affiliation: Hôpital Foch
name: Bertrand Lapergue, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Slaoui T, Klein IF, Guidoux C, Cabrejo L, Meseguer E, Abboud H, Lavalllee PC, Mazighi M, Labreuche J, Amarenco P. Prevalence of subdiaphragmatic visceral infarction in cardioembolic stroke. Neurology. 2010 Mar 30;74(13):1030-2. doi: 10.1212/WNL.0b013e3181d76aaa. Epub 2010 Mar 3.
citation: Abboud H, Labreuche J, Gongora-Riverra F, Jaramillo A, Duyckaerts C, Steg PG, Hauw JJ, Amarenco P. Prevalence and determinants of subdiaphragmatic visceral infarction in patients with fatal stroke. Stroke. 2007 May;38(5):1442-6. doi: 10.1161/STROKEAHA.106.476804. Epub 2007 Mar 22.
citation: Flint AC, Tayal AH. The search for paroxysmal atrial fibrillation in cryptogenic stroke: leave no stone unturned. Neurology. 2013 Apr 23;80(17):1542-3. doi: 10.1212/WNL.0b013e31828f1938. Epub 2013 Mar 27.
citation: White H, Boden-Albala B, Wang C, Elkind MS, Rundek T, Wright CB, Sacco RL. Ischemic stroke subtype incidence among whites, blacks, and Hispanics: the Northern Manhattan Study. Circulation. 2005 Mar 15;111(10):1327-31. doi: 10.1161/01.CIR.0000157736.19739.D0.
Clinical trial NCT04425044: AiM Covid Self Monitoring
Official title: Efficacy of AiM Covid Self Monitoring in Detecting Infection of COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Lead sponsor: Aarogyam UK
Sponsor class: OTHER
Collaborators: name: University of Warwick
name: NMP Medical Research Institute
name: Mothers Touch Foundation
First posted: 2020-06-11
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Anyone worried about heath status relating with infection of COVID-19

Brief summary: The objectives of this study are to test the level of accuracy of the prediction models that could be used as a 'digital test' to evaluate whether an individual is infected with COVID-19, based on their symptoms reported in the "AiM COVID-19" app


Eligibility criteria: Inclusion Criteria:

* Participants resident in India
* Voluntary completion of the self-test and evaluation.

Exclusion Criteria:

* People can not use mobile app
* Below 18 years old

Primary outcomes:
measure: Fever
timeFrame: 1 day
Secondary outcomes:
measure: Shortness of Breath
timeFrame: 1 day
measure: Cough
timeFrame: 1 day
measure: Sore Throat
timeFrame: 1 day
measure: Headache
timeFrame: 1 day
measure: Muscle/ Joint Pain
timeFrame: 1 day
measure: Diarrhoea
timeFrame: 1 day
measure: Vomiting/ Nausea
timeFrame: 1 day
measure: Runny Nose
timeFrame: 1 day
measure: Loss of Smell/Taste
timeFrame: 1 day
measure: Other symptoms
timeFrame: 1 day
Other outcomes:
Locations:
city: Mumbai
country: India
facility: Mothers Touch Foundation
state: Maharashtra
city: Jaipur
country: India
facility: NMP Medical Research Institite
state: Rajasthan
Study officials:
affiliation: University of Warwick
name: Vishwes Kulkarni
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06765044: Textbook Outcomes in Urgent Appendectomy
Official title: Textbook Outcomes of Surgical Treatment of Acute Appendicitis
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Valid MeSH Conditions
Keywords: Textbook Outcomes
Laparoscopy
Acute Appendicitis
Open Surgery
Urgent Appendectomy
Lead sponsor: Hospital del Mar
Sponsor class: OTHER
First posted: 2025-01-09
Enrollment: 500
Sex: ALL
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: All the admissions with diagnostic of Acute Appendicitis in an University Hospital

Brief summary: A "textbook outcome" patient is defined as one whose surgical course is uneventful, with no complications, readmissions, or mortality. There is a lack of published research regarding textbook outcomes with an acute appendicitis that are treated with an appendectomy.

Detailed description: The objective of this study is to analyze the attainment of textbook outcomes (TO) in patients undergoing urgent appendicectomy (UA) for acute appendicitis and to identify the factors associated with achieving TO.

Eligibility criteria: Inclusion Criteria:

* Acute Appendicits in older than 18 years old
* Acute Appendicitis that needs appendectomy

Exclusion Criteria:

* Age under 18 years old
* Other diagnostic than an Acute Appendicitis

Primary outcomes:
measure: Textbook Outcomes
timeFrame: 2022-2024
Secondary outcomes:
measure: Appendectomy in less than 24h
timeFrame: 2022-2024
measure: Hospital Stay less than 5 days
timeFrame: 2022-2024
measure: Intraoperative incidences
timeFrame: 2022-2024
measure: Short antibiotics treatment
timeFrame: 2022-2024
measure: Patient comorbidities
timeFrame: 2022-2024
measure: Surgical Risk
timeFrame: 2022-2024
measure: Intraoperative appendicitis gradding
timeFrame: 2022-2024
measure: Postperative complications
timeFrame: 2022-2024
measure: Readmision index
timeFrame: 2022-2024
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00005744: Increased Physical Activity in African-American Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Heart Diseases
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2000-05-26
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To conduct a randomized demonstration and education trial of churches in East Baltimore testing a self-help, minimal intervention compared with an intensive physical activity intervention.

Detailed description: BACKGROUND:

The study filled an existing gap by examining how a culturally sensitive physical activity intervention conducted in a community setting was associated with increased daily energy expenditure in African American women -- a group of women who are sedentary and at risk for health problems for which regular physical activity can provide benefits.

DESIGN NARRATIVE:

An evaluation was conducted of the effectiveness of a six-month moderate-intensity physical activity intervention for increasing total daily energy expenditure of sedentary African-American women who were between the ages of 50 and 70 years. The goal of the intervention was to increase total daily energy expenditure by 150 kilocalories per day and time spent in moderate-intensity physical activity by 30 minutes per day. Effects of increased physical activity on selected cardiovascular risk factors (e.g., peak oxygen uptake, blood pressure, HDL cholesterol, serum insulin and plasma glucose) were also determined. Six churches were randomized into intensive or minimal intervention status, and 33 women per church were recruited, for a total of 100 women in each condition. The physical activity intervention consisted of twice-weekly aerobics classes conducted at the churches and additional group-and home-based programming. Volunteer lay leaders were trained as neighborhood exercise specialists to supplement certified aerobics instructors in conducting the intervention.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Johns Hopkins University
name: Deborah Young
References:
citation: Young DR, Gittelsohn J, Charleston J, Felix-Aaron K, Appel LJ. Motivations for exercise and weight loss among African-American women: focus group results and their contribution towards program development. Ethn Health. 2001 Aug-Nov;6(3-4):227-45. doi: 10.1080/13557850120078143.
citation: Young DR, Jee SH, Appel LJ. A comparison of the Yale Physical Activity Survey with other physical activity measures. Med Sci Sports Exerc. 2001 Jun;33(6):955-61. doi: 10.1097/00005768-200106000-00015.
citation: Young DR, King AC, Sheehan M, Stefanick ML. Stage of motivational readiness: predictive ability for exercise behavior. Am J Health Behav. 2002 Sep-Oct;26(5):331-41. doi: 10.5993/ajhb.26.5.2.