louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00745784: Prolonged Grief in Young Bereaved Spouses and Partners
Official title: Lost to Cancer: Prolonged Grief in Young Bereaved Spouses and Partners
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Grief
Keywords: Young Bereaved Spouses
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Calvary Hospital, Bronx, NY
First posted: 2008-09-03
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Only spouses/partners of deceased Calvary and Memorial Sloan Kettering patients will be assessed in this study.

Brief summary: The purpose of the research is to learn more about the experience of grief in young bereaved spouses/partners. Recent research has shown that young bereaved spouses/partners experience grief uniquely from other age groups, but it is still unclear how certain factors affect the experience of grief. The investigators research team is interested in studying how the psychological factors of trauma, personality, and meaning of the loss affect grief reactions in young spouses/partners after the loss of a spouse to cancer.


Eligibility criteria: Inclusion Criteria:

* Participants must be at least 20 years old and no older than 49 years and 11 months old.
* Participants must have lost a spouse/domestic partner to cancer 6 months to 3 years earlier.
* Participants must be able to give informed consent.
* Participants must be able to comprehend English to complete study assessments.

Exclusion Criteria:

* Major psychopathology or cognitive impairment likely in the judgment of the research staff to interfere with the participation or completion of the protocol.

Primary outcomes:
measure: To determine the rate and levels of prolonged grief in young bereaved spouses/partners of cancer patients
timeFrame: conclusion of the study
Secondary outcomes:
measure: To determine associations among prolonged grief, personality characteristics , previous trauma, & subjective meanings of the loss to the bereaved spouse in young bereaved spouses/partners of cancer
timeFrame: conclusion of the study
measure: To evaluate whether unique themes emerge among those reporting prolonged grief
timeFrame: conclusion of the study
measure: To evaluate whether unique themes emerge among those reporting obsessive and histrionic personality traits
timeFrame: conclusion of the study
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Calavery Hospital
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Calvary Hospital, Bronx, NY
name: Sherry Schacter, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02860884: Using Infrared Spectroscopy for Diagnosis Severity of Nonalcoholic Fatty Liver Disease
Official title: Using Infrared Spectroscopy for Diagnosis Severity of Nonalcoholic Fatty Liver Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fatty Liver
Non-alcoholic Fatty Liver Disease
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2016-08-09
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who have undergone a liver biopsy for simple fatty liver or NASH and for which a serum sample is serum bank

Brief summary: The main objective of this study is to evaluate the ability of infrared spectroscopy to discriminate simple hepatic steatosis from NASH


Eligibility criteria: Inclusion Criteria:

* Patients who have undergone a liver biopsy for simple fatty liver or NASH and for which a serum sample is serum bank
* Men or Women
* aged of 18 years or more
* After giving their consent to participate in research

Exclusion Criteria:

* Known Cancer
* Refusal of consent
* Inflammatory disease

Primary outcomes:
measure: Sensitivity
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Rennes
country: France
facility: Centre hospitalier universitaire de Rennes
Study officials:
References:
Clinical trial NCT00545584: Addition Of Januvia (Sitagliptin) Improves Glycemic Control In Patients Inadequately Controlled By Metformin (MK0431-078)
Official title: Multicenter, Open, Pragmatic, Randomized Trial Comparing the Efficacy of 3 Different Lifestyle Interventions After Addition of Sitagliptin to Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Non-Insulin-Dependent
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-10-17
Enrollment: 1512
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the efficacy of three strategies of lifestyle changes associated with Januvia (sitagliptin) 100 mg/day in patients with Type 2 Diabetes Mellitus (T2DM) inadequately controlled by metformin (hemoglobin A1c \[HbA1c\] 6.5-9%). A difference between the three strategies of lifestyle changes was expected.


Eligibility criteria: Inclusion Criteria:

* Man or woman aged \>/= 18 years,with T2DM and treated with the maximal tolerated dose of metformin, with documented or high likely inadequate control of diabetes (HbA1c 6.5-9%)

Exclusion Criteria:

* Daily insulin treatment or one insulin dose or more within the last 8 weeks or expected insulin treatment within the next 3 months.
* Hypoglycemia unawareness or recurrent major hypoglycemia or history of acidoketosis
* Known hypersensitivity or contraindication to metformin

Primary outcomes:
measure: Hemoglobin A1c Measurement
timeFrame: Baseline and Week 24
Secondary outcomes:
measure: Fasting Plasma Glucose (FPG) Measurement
timeFrame: Baseline and Week 24
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT04500184: Exercise-based Cardiac Rehabilitation After Thoracoscopic Ablation in Patients With Persisent Atrial Fibrillation
Official title: Can Exercise-based Cardiac Rehabilitation Increase Physical Activity in Patients Who Undergoing Totally Thoracoscopic Ablation?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation, Persistent
Cardiac Rehabilitation
Cardiopulmonary Fitness
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2020-08-05
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who underwent thoracoscopic ablation were included. cardiac rehabilitation was performed according to the willingness of each patients.

Brief summary: Thoracoscopic ablation is a promising treatment of persistent atrial fibrillation. However, the postoperative rehabilitation is very important to prevent early recurrence of atrial arrhythmia. The purpose of this study is to evaluate the efficacy of professional cardiac rehabilitation in patients after thoracoscopic ablation.


Eligibility criteria: Inclusion Criteria:

* patients who underwent thoracoscopic ablation due to persisent atrial fibrillation

Exclusion Criteria:

* below 18 years
* over 80 years old
* malignancy
* pregnancy

Primary outcomes:
measure: Recurrence of atrial fibrillation
timeFrame: every 6 months for 1 year
measure: functional recovery
timeFrame: 6 months after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Dong Seop Jeong, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02010502: Beet Root Supplement Trial
Official title: Effects of Two Forms of Beetroot Juice Supplementation on Exercise Performance in Cyclists
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trained or Competitive Cyclists
Keywords: Beet root
exercise performance
cyclists
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2013-12-12
Enrollment: 12
Sex: MALE
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: To examine the effects of two forms of beetroot juice supplementation on exercise performance in trained cyclists.


Eligibility criteria: Inclusion Criteria:

* good physical health
* trained or competitive cyclist
* between 18-40 years of age

Exclusion Criteria:

- have used any anabolic or ergogenic supplementation in the last 1-3 months

Primary outcomes:
measure: Time to completion
timeFrame: Baseline to week 8
Secondary outcomes:
measure: O2 consumption
timeFrame: Baseline to Week 8
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: Richardson Centre for Functional Foods and Nutraceuticals
state: Manitoba
Study officials:
References:
Clinical trial NCT02726802: Effectiveness of Two Different Entry Portal Pathways Into Primary Care for Musculoskeletal Injury
Official title: Effectiveness of Two Different Entry Portal Pathways Into Primary Care for Musculoskeletal Injury: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Physical Therapy Direct Access
Physical Therapy Primary Care
Lead sponsor: Reynolds Army Community Hospital
Sponsor class: FED
Collaborators: name: Brooke Army Medical Center
name: Temple University
First posted: 2016-04-04
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to compare the self-report functional outcome measures, medical readiness and healthcare utilization (overall cost of imaging, prescription medications for pain, and follow-up visits) of soldiers with musculoskeletal injuries first seen by a physical therapist versus primary care provider.


Eligibility criteria: Inclusion Criteria:

* Adults over age 18
* Musculoskeletal injury or complaint \< 3 months since onset
* Active duty service member, reachable by phone/e-mail within 3 months of initial encounter

Exclusion Criteria:

* Subject currently has a permanent profile for any reason OR subject has a temporary profile for a body part in the same half of the body as the current complaint OR solider is pending physical examination board (PEB) or undergoing/pending medical examination board (MEB)
* Individuals undergoing PEB/MEB are made aware that the end-state of the process includes a certain percentage of government monetary compensation based on their physical or mental disability, i.e, higher disability equates to greater pay. Because of this, individuals may be motivated to demonstrate worse outcomes as it may result in a higher disability "rating". For this reason, these individuals will be excluded from the study.
* Subject has been treated previously for the same condition within the past 3 months
* Subject has history of surgery for the same body part within the past 24 months

Primary outcomes:
measure: Patient Specific Functional Scale
timeFrame: 3 months
measure: PROMIS physical function scale
timeFrame: 3 months
measure: Global Rating of Change (GROC)
timeFrame: 3 months
measure: Defense and Veterans Pain Rating Scale
timeFrame: 3 months
Secondary outcomes:
measure: Self-Report Medical Readiness Questionnaire
timeFrame: 3 months
measure: Medical Profile Status
timeFrame: 3 months
measure: Overall Healthcare Consumption
timeFrame: 12 months
measure: Patient Satisfaction
timeFrame: 3 months
measure: Report of adverse events
timeFrame: 3 months
Other outcomes:
Locations:
city: Fort Sill
country: United States
facility: Reynolds Army Community Hospitral
state: Oklahoma
Study officials:
References:
Clinical trial NCT04355702: Covid-19 in Lupus Patients
Official title: Manifestations Related to Covid-19 in Patients With Systemic Lupus Erythematosus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Systemic Lupus Erythematosus
Covid-19
Keywords: Systemic lupus erythematosus
Hydroxychloroquine
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2020-04-21
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult patients with systemic lupus erythematosus followed by the departments of rheumatology and nephrology, seen during the last year

Brief summary: The Covid-19 pandemic is a major public health issue. Potential treatments are essential to control the infection. Hydroxychlorquine is currently tested in several clinical trials to evaluate its efficiency.The objective of this study was to evaluate the symptoms related to COVID-19 occuring in patients with systemic lupus erythematosus (SLE)

Detailed description: Introduction:The Covid-19 pandemic has had a major impact on many countries on the sanitary and economic level. Finding an efficient cure is paramount in order to reduce its severity and mortality. Several medications are currently under investigation. Among them, hydroxychloroquine can prevent viral replication at several sites and has been shown efficient in vitro. Several clinical trials are in progress to evaluate its efficiency in vivo. However, no study so far has evaluated the covid-19 infection in patients with SLE.

Objectives and methods: The primary objective was to describe the prevalence and the severity of Covid-19 infection in patients wih systemic lupus erythematosus. The secondary objective was to compare these parameters in patients treated by hydroxychloroquine and those not treated by hydroxychloroquine. This observational study of a historical-prospective cohort focuses on all adult lupus patients seen during the last year in the departments of rheumatology and nephrology in CHU Montpellier. It will collect information concerning the patient's condition, treatments and main comorbidities (cardio-vascular, respiratory, hepatic and immune depression), as well as symptoms suggesting covid-19 infection, its confirmation and its course and severity.

Eligibility criteria: Inclusion criteria:

- adult patient with systemic lupus erythematosus seen during the last year in the departments of rheumatology or nephrology

Exclusion criteria:

- patient not speaking french nor english

Primary outcomes:
measure: prevalence and severity of Covid-19 infection in patients with SLE
timeFrame: 1 day
Secondary outcomes:
measure: prevalence and severity of Covid-19 infection in patients treated by hydroxychloroquine
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Christian JORGENSEN, Resident
role: STUDY_DIRECTOR
References:
Clinical trial NCT06745102: Hop Compounds on the Immune System in Overweight People
Official title: Effect of Iso-alpha Acids and Xanthohumol on the Human Immune System in Overweight People With the Onset of Metabolic Diseases
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Inflammatory Response
Lead sponsor: University of Vienna
Sponsor class: OTHER
First posted: 2024-12-20
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of the present study is to determine the effect of Iso-alpha Acids and Xanthohumol from hops on the immune response in overweight participants.

Detailed description: The aim of the present study is to investigate whether the oral intake of Xanthohumol and Iso-alpha Acids has different protective effects on the immune response of isolated blood cells from overweight people with people with incipient metabolic diseases, what the time course of the effect is and whether the levels of the substances differ from normal-weight individuals.

After taking a fasting blood sample, the study participants receive one of the study drinks and a light breakfast. Both should be consumed within 15 minutes. Further blood samples are taken 1, 2, 3, 4 and 6 hours after the drinks have been consumed. To assess the effect of Xanthohumol and Iso-alpha Acids or a combination of both, clinical parameters, blood lipids, blood glucose, uric acid and inflammatory markers will be determined. Furthermore, blood cells, isolated from blood samples of each time point, will be stimulated for measuring inflammatory markers.

Eligibility criteria: Inclusion Criteria:

* BMI 25 - 29,9 kg/m²

as well as one or more of the following incipient metabolic diseases:

* pre-diabetes (fasting blood glucose 100-125 mg/dL),
* fatty liver (grade 1-3),
* high-normal blood pressure to mild hypertension (grade 1, systolic 140-159 mmHg)

Exclusion Criteria:

* History of diseases that could falsify the study results
* inflammatory bowel diseases
* malignant diseases of the gastrointestinal tract
* food allergies
* malabsorption
* kidney or liver disease (except simple fatty liver)
* symptomatic heart failure
* Taking medication to treat these diseases
* Consumption of special diets (e.g. vegan, gluten-free)
* Pregnancy

Primary outcomes:
measure: Changes in parameters of immune response
timeFrame: 6 hours
measure: Changes in parameters of immune response
timeFrame: 6 hours
measure: Changes in parameters of immune response
timeFrame: 6 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: University of Vienna
Study officials:
References:
Clinical trial NCT04068402: Vivio AS (Aortic Stenosis) Algorithm Optimization Study
Official title: Optimization of the Vivio System Algorithm as an Aid in the Identification of Heart Sounds Associated With Severe Aortic Stenosis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Aortic Stenosis
Lead sponsor: Avicena LLC
Sponsor class: INDUSTRY
First posted: 2019-08-28
Enrollment: 0
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Optimize a candidate software algorithm using data collected with the Vivio system for use as an aid in the identification of heart sounds associated with severe aortic stenosis

Detailed description: Prospective, non-randomized, single-center study of adult subjects referred for echocardiography. Total of 200 enrolled subjects at 1 site

Enrolled subjects will undergo:

Vivio system data capture, standard of care transthoracic echocardiogram (TTE). Vivio analysis will not be available to non-Avicena personnel

Eligibility criteria: Inclusion Criteria:

1. Adult subjects (21 years of age or older).
2. Referred for transthoracic echocardiography by physician/primary care provider/cardiologist.
3. Willing and able to participate in all study evaluations and allow access to medical testing and records.
4. Ability to understand and sign an informed consent or have a legally authorized representative to provide informed consent on behalf of the subject.

Exclusion Criteria:

1. Acute coronary syndrome, cardiogenic shock or the need for inotropic/mechanical circulatory support.
2. Need for bedside echocardiogram (inpatient).
3. Prosthetic device previously implanted at aortic valve position.
4. Inability to palpate carotid pulse
5. History of carotid sinus hypersensitivity (i.e. fainting in response to touching or positioning the neck).
6. History of significant carotid artery disease or treatment (surgery, stenting, \> 50% stenosis in both left and right carotid artery).
7. Open skin lesions at target site of Vivio examination.

Primary outcomes:
measure: Primary Endpoint - Generation of an optimized algorithm that can be used to develop an algorithm for use as an aid in the identification of heart sounds associated with severe aortic stenosis.
timeFrame: 48 hours
Secondary outcomes:
measure: Secondary Endpoint - Incidence of Adverse Events: Summary of all reported adverse events during the study
timeFrame: 48 hours
Other outcomes:
Locations:
city: Grand Rapids
country: United States
facility: Spectrum Health
state: Michigan
Study officials:
affiliation: Avicena LLC
name: Sean Brady, JD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00605202: Effect of Licorice and Hydrochlorothiazide on Plasma Potassium
Official title: Effect of Licorice and Hydrochlorothiazide on Plasma Potassium
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypokalemia
Lead sponsor: University of Oulu
Sponsor class: OTHER
First posted: 2008-01-30
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This clinical trial is designed to study the effect of the combination of licorice and hydrochlorothiazide on plasma potassium levels in volunteers. In one arm, 10 healthy volunteers will be given 32 grams of licorice a day together with a 25 mg dose of daily hydrochlorothiazide for 14 days. This combination is compared with 32 grams of licorice a day for 14 days given in the other arm. The study is a randomized, open-label cross-over trial. There is at least a 3-week wash-out between the arms. The hypothesis is that the combination of licorice and hydrochlorothiazide will cause hypokalemia. The main outcome measure is the change in the plasma level of potassium between the arms.


Eligibility criteria: Inclusion Criteria:

* Healthy volunteer
* Age 18-40 years

Exclusion Criteria:

* Any continuous medication
* Any significant disease
* Hypotension or hypertension
* Allergy to licorice or hydrochlorothiazide
* Pregnancy and breast feeding
* Fear of needles and previous difficult blood samplings
* Substance abuse
* Participation in another clinical drug trial within 1 month of enrollment

Primary outcomes:
measure: Plasma Potassium
timeFrame: Baseline and 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: Oulu University Hospital
Study officials:
affiliation: Oulu University Hospital
name: Markku Savolainen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hukkanen J, Ukkola O, Savolainen MJ. Effects of low-dose liquorice alone or in combination with hydrochlorothiazide on the plasma potassium in healthy volunteers. Blood Press. 2009;18(4):192-5. doi: 10.1080/08037050903072515.