louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05388097: Effect of a Quality Improvement Initiative to Address Social Determinants of Health on Rehospitalization Rates in Patients With Heart Failure
Official title: A Novel Strategy for Addressing Social Barriers to a Successful, Sustained Discharge From the Hospital for Acute Heart Failure
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Heart Failure
Keywords: heart failure
Lead sponsor: Saint Luke's Health System
Sponsor class: OTHER
Collaborators: name: Truman Medical Center
name: University of Missouri, Kansas City
name: Mid America Regional Council
First posted: 2022-05-24
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The objective of this program is to improve post-acute care coordination for necessary social services for patients leaving the hospital after recovering from an episode of decompensated heart failure.


Eligibility criteria: Inclusion Criteria:

* Aged 18-99 years
* Resident of Missouri or Kansas
* Current inpatient admission for acute heart failure

Exclusion Criteria:

* Under 18 years or over 99 years of age

Primary outcomes:
measure: Reduction in all-cause re-hospitalization
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Olathe
country: United States
facility: Olathe Health System
state: Kansas
city: Kansas City
country: United States
facility: University Health Truman Medical Center
state: Missouri
city: Kansas City
country: United States
facility: Saint Luke's Hospital of Kansas City
state: Missouri
Study officials:
References:
Clinical trial NCT04725097: A Study to Evaluate Rapid Throughput Screening for Human COVID-19 Infection
Official title: Rapid Throughput Screening for Human COVID-19 Infection: A ECG Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Covid19
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-01-26
Enrollment: 2821
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Detection of COVID-19 when compared to a PCR test in asymptomatic patients.

Brief summary: The purpose of this study is to assess the ability of an artificial intelligence smartphone-enabled point of care ECG to detect COVID-19.


Eligibility criteria: Inclusion Criteria:

* Adult males and females age 18 or greater.
* Undergoing COVID-19 testing by PCR.
* Willing and able to provide informed consent.
* Pregnant females (minimal risk study, no risk from ECG).

Exclusion Criteria:

- Unwilling or unable to provide informed consent.

Primary outcomes:
measure: COVID 19 Detection
timeFrame: One time screening within 4 hours of PCR test
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic
state: Arizona
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: Shreveport
country: United States
facility: LSUHSC Shreveport
state: Louisiana
city: West Bloomfield
country: United States
facility: Henry Ford Health System
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Hackensack
country: United States
facility: Hackensack Meridian Health
state: New Jersey
city: Bengaluru
country: India
facility: Sri Jayadeva
state: Karnataka
city: Mumbai
country: India
facility: King Edward Memorial Hospital
state: Maharashtra
city: Madrid
country: Spain
facility: Gregorio Marañon Hospital
city: London
country: United Kingdom
facility: Imperial College
state: England
Study officials:
affiliation: Mayo Clinic
name: Elie F Berbari, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01564797: Partnership for a Hispanic Diabetes Prevention Program
Official title: Partnership for a Hispanic Diabetes Prevention Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Pre-diabetes
Keywords: Diabetes
haemoglobin A1C
Hispanic
Behavioural Intervention
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
First posted: 2012-03-28
Enrollment: 430
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aims of the study are to investigate

1. the effects of an intervention vs. control on levels of glycosylated haemoglobin (haemoglobin A1c) in Hispanic participants, older than 18 years, who have elevated hA1c at baseline (\>6.0%). Glycosylated haemoglobin provides an indication of blood sugar levels over the past 3 months. Elevated hA1c levels are seen in diabetics and pre-diabetics.
2. the effects of the intervention vs control on consumption of fresh fruit and vegetables
3. the effects of the intervention vs control on levels of physical activity


Eligibility criteria: Inclusion Criteria:

* Aged 18 years and older
* Haemogloblin A1c ≥ 6.5%
* Hispanic Ethnicity

Primary outcomes:
measure: Effect of the intervention on serum levels of hA1c in diabetics and pre-diabetic participants
timeFrame: Baseline, 3 months
measure: Effect of the intervention on consumption of fresh fruit and vegetables in diabetics and pre-diabetic participants
timeFrame: Baseline, 3 months
measure: Effect of the intervention on physical activity levels in diabetics and pre-diabetic participants
timeFrame: Baseline, 3 months
Secondary outcomes:
measure: Effect of the intervention on changes in knowledge and attitudes about diabetes
timeFrame: Baseline, 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Fred Hutchinson Cancer Center
name: Beti Thompson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Duggan C, Carosso E, Mariscal N, Islas I, Ibarra G, Holte S, Copeland W, Linde S, Thompson B. Diabetes prevention in Hispanics: report from a randomized controlled trial. Prev Chronic Dis. 2014 Feb 27;11:E28. doi: 10.5888/pcd11.130119.
Clinical trial NCT00598897: Use of Clarithromycin and Rifabutin for the Treatment of M. Avium Complex (MAC) Lung Disease
Official title: Open, Noncomparative Trial of Multidrug Regimens Containing Clarithromycin and Rifabutin Administered Three Times Per Week for the Treatment of M. Avium Complex (MAC) Lung Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Mycobacterium Avium Complex Lung Disease
Keywords: MAC
Lead sponsor: The University of Texas Health Science Center at Tyler
Sponsor class: OTHER
Collaborators: name: Abbott
name: Pfizer
First posted: 2008-01-23
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To determine the safety and tolerance of clarithromycin given three times per week in combination with multiple drugs including rifabutin three times per week

Detailed description: Safety and tolerance of clarithromycin given 3 times weekly with multiple drugs including ethambutol and rifampin/rifabutin

Eligibility criteria: Inclusion Criteria:

* Meet American Thoracic Society criteria for nontuberculous mycobacterial lung disease: two or more AFB smear positive, culture positive sputums or bronchoscopic samples and/or two or more AFB smear negative respiratory samples with moderate to heavy growth (2+-4+); abnormal CXR consistent with M. avium lung disease; absence of other potential mycobacterial or fungal lung pathogens (except for the coexistence of M. abscessus).
* Adults age 18 and older
* Pretreatment isolate of M. avium complex available for MIC determination

Exclusion Criteria:

* History of allergy to study drugs
* If a mensruating female, not pregnant and on adequate birth control.
* Children less than 18 years of age
* HIV + or at high risk for HIV infection.

Primary outcomes:
measure: Clinical and microbiological outcomes such as clinical symptoms and laboratory cultures
timeFrame: 6 months
Secondary outcomes:
measure: Clinical and microbiological outcomes
timeFrame: 1 yr
Other outcomes:
Locations:
city: Tyler
country: United States
facility: The University of Texas Health Science Center at Tyler
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center at Tyler
name: Richard J Wallace Jr., M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00725205: Patient Compliance During PegIntron and Rebetol Combination Therapy in Chronic Hepatitis C (Study P04690)
Official title: Patient Compliance During PegIntron (Injection Pen) and Rebetol Combination Therapy in Chronic Hepatitis C
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C, Chronic
Hepatitis C
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-07-30
Enrollment: 294
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: Untreated chronic hepatitis C (CHC) participants starting Peginterferon alfa-2b (injection pen) and Ribavirin combination therapy as their usual medical treatment according to the approved dosage/regimen were selected for this study.

Brief summary: Participants will receive PegIntron injection pen (Peginterferon alfa-2b) and Rebetol (Ribavirin) combination therapy as their usual medical treatment. The current study aims to evaluate whether the previously introduced, and now widely accepted and implemented educational program, which represents additional efforts in everyday practice to increase patient compliance, will succeed in achieving adherence rate in treated participants similar to the extent demonstrated by clinical trials.


Eligibility criteria: Inclusion Criteria:

* Before inclusion, all participants must be informed and must give consent for the use of his/her anonymized health data related to his/her treatment with Peginterferon alfa-2b (injection pen) and Ribavirin.

Exclusion Criteria:

* According to Peginterferon alfa-2b/Ribavirin label.

Primary outcomes:
measure: Number of Participants Who Are Triple-80 Compliant
timeFrame: 24 or 48 Weeks
Secondary outcomes:
measure: Number of Participants Who Achieved Sustained Virological Response as Assessed at 24-week Post-treatment Follow-up
timeFrame: 24 Weeks following completion of 24 or 48 weeks of therapy
measure: Number Of Participants Self-Administering Pegylated Interferon Alfa-2b
timeFrame: Up to 48 Weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04954105: Influence of the COvid-19 Epidemic on STRESS and Heart-Rate Variability in Health-care Workers
Official title: Influence of the COvid-19 Epidemic on STRESS and Heart-Rate Variability in Health-care Workers
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stress
Heart Rate Variability, Biomarker of Stress
Burnout
Keywords: Stress
Coronavirus
HAZMAT
Epidemics
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: University Hospital of Clermont-Ferrand (CHU), Clermont-Ferrand, France
name: UMR CNRS 6024 LaPSCo, Clermont-Ferrand, France
name: Wittyfit, Paris, France
First posted: 2021-07-08
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Emergency health care worker

Brief summary: The COVID-19 pandemic is an exceptional and particularly anxiety-provoking health situation. In particular, for healthcare professionals who come into contact with patients who are contaminated or suspected of contamination, such as emergency rooms. The management of these patients requires reinforced protective equipment. However, in the context of this pandemic, data is currently non-existent on the objective measurement of the stress of these professionals. Sinus variability of heart rate is a biomarker of stress measured with a simple heart rate monitor or a watch, completely painless, non-intrusive, and used by the general public routinely in many areas (monitoring sports sessions, etc.).

Detailed description: This is an observational study. In the emergency room, each participant will wear a heart rate monitor and a consumer watch throughout the working day (there will be no measurement on duty at night, nor measurement at home). The days will be notified as being in the "COVID sector", "non-COVID sector" or "Trauma Room".

Each participant will complete a questionnaire comprising visual analog scales on the feeling (health concern, stress, fatigue, quality of sleep, anxiety, morale, burnout, decisional latitude, psychological demand, support, self-esteem), time of start and end of work, and socio-demographic data (sex, age, weight, height, smoking)

Eligibility criteria: Inclusion Criteria:

* Emergency health care worker

Exclusion Criteria:

* refusal to participate

Primary outcomes:
measure: Heart-Rate Variability (HRV)
timeFrame: up to day 1
Secondary outcomes:
measure: Stress
timeFrame: hours 0 at day 1
measure: Stress
timeFrame: hours 24 at day 1
measure: Perception of the epidemic
timeFrame: day 1
measure: Sociodemographic factors and lifestyle habits
timeFrame: day 1
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU clermont-ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Jean-Baptiste Bouillon-Minois
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06533605: Phase I Clinical Study to Evaluate the Safety and Efficacy of SSGJ-706 Monotherapy for Patients With Advanced Solid Tumors
Official title: Phase I Clinical Study to Evaluate the Safety, Tolerability, and Initial Efficacy of SSGJ-706 Monotherapy for Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Advanced Solid Tumors Patients
Keywords: Solid Tumors
Lead sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-08-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study includes two parts, different part has different administration frequencies of SSGJ-706.

Detailed description: This study is a study of SSGJ-706 monotherapy in advanced Solid Tumors. This study includes two parts, different part has different administration frequencies of SSGJ-706. Part A is QW and part B is Q3W. Each part will assess the efficacy and safety of the preset several dose levels of SSGJ-706 in advanced Solid Tumors.

Eligibility criteria: Inclusion Criteria:

1. Males and/or females over age 18
2. Histologically and/or cytologically documented advanced or metastatic Solid Tumors .
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
4. Expected survival \>=3 months.
5. Signed informed consent form.

Exclusion Criteria:

1. Known uncontrolled or symptomatic central nervous system metastatic disease.
2. Adverse events (with exception of alopecia and fatigue) from any prior anticancer therapy of grade \>1 (National Cancer Institute Common terminology Criteria \[NCI CTCAE\] v.5.0).
3. Inadequate organ or bone marrow function.
4. Pregnant or breast-feeding woman.
5. Known allergies, hypersensitivity, or intolerance to SSGJ-706 The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Primary outcomes:
measure: DLTs
timeFrame: 12 months
measure: MTD or MAD
timeFrame: 12 months
Secondary outcomes:
measure: The blood concentration of SSGJ-706
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02491905: Safety and Efficacy of HL Tablet in Non-alcoholic Fatty Liver Disease Patients
Official title: Phase 2 Study to Assess Safety and Efficacy of HL Tablet on Reducing Hepatic Fat in Non-alcoholic Fatty Liver Disease Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-alcoholic Fatty Liver Disease
Lead sponsor: Huons Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-07-08
Enrollment: 69
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the safety and efficacy of HL tablet on reducing hepatic fat in non-alcoholic fatty liver disease patients. The patients are allocated to three groups; low dose, high dose, and placebo control group.


Eligibility criteria: Inclusion Criteria:

1. Age between 19 and 75
2. Non-alcoholic fatty liver disease patient

   * Diagnosed by abdomen ultrasonic examination
   * Non-drinker (alcohol intake per week : female-under 140g, male-under 210g)
3. ALT or AST higher than normal range (not over 4 times normal range)
4. Voluntary agreement and enrollment

Exclusion Criteria:

1. The ratio of AST/ALT over 2
2. Type I diabetes mellitus patient
3. Any dysfunction of liver besides non-alcoholic fatty liver disease
4. Alcoholic fatty liver disease patient or heavy drinker
5. Prior treatment with any medicine which affects the treatment of non-alcoholic fatty liver disease within 3 months
6. Patient taking any product which affects the BMI or hyperlipidemia
7. Any dyscrasia that investigator considers not to appropriate for this study
8. Bariatric surgery within 6 months
9. Any disease which is able to change the distribution of cytokines
10. Any treatment that affects liver functions within 1 month
11. Participation in other clinical trials within 3 months
12. Person who can not use MRS
13. Pregnancy or breast-feeding
14. Fertile women who do not use contraception
15. Sensitive to the investigational product
16. Any conditions that the investigator considers not to appropriate for this study

Primary outcomes:
measure: To assess the change of hepatic fat by Magnetic Resonance spectroscopy (MRS) after administration of HL tablet compared with baseline
timeFrame: 12 weeks
Secondary outcomes:
measure: Changes in Alanine Transaminase (ALT)
timeFrame: 8 and 12 week
measure: Changes in Asparate Transaminase (AST)
timeFrame: 8 and 12 week
measure: Changes in cholesterol
timeFrame: 8 and 12 week
measure: Changes in triglyceride
timeFrame: 8 and 12 week
measure: Changes in free fatty acid
timeFrame: 8 and 12 week
measure: Changes in insulin resistance
timeFrame: 8 and 12 week
measure: Changes in Body Mass Index (BMI)
timeFrame: 8 and 12 week
Other outcomes:
Locations:
city: Ansan
country: Korea, Republic of
facility: Huons
state: Kyeonggi-do
Study officials:
References:
Clinical trial NCT04192305: Impact of LPV During OFA on Postoperative Oxygen Saturation.
Official title: Observational Study Evaluating the Impact of Lung Protective Ventilation (LPV) During Opioid Free Anesthesia (OFA) on Postoperative Oxygen Saturation.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Oxygen Saturation
Lead sponsor: AZ Sint-Jan AV
Sponsor class: OTHER
First posted: 2019-12-10
Enrollment: 100
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: bariatric surgery is performed in obese patients with BMI \> 35

Brief summary: Observational study comparing patients with lung protective ventilation (LPV) following the consensus guidelines by Young C with patients getting routine lung ventilation, both during opioid free anesthesia (OFA).

Detailed description: The paper by C Young et al describes the essential steps in protecting the lungs and preventing post operative pulmonary complications (PPC) like alveolar collapse.

Alveolar collapse can be measured by oxygen saturation drop when no oxygen therapy is given, when full neuromuscular block (NMB) reversal and no opioid is given intra and postoperative.

LPV means:

tidal volume of 6 ml/kg, inspiratory-expiratory (I/E) ratio of 1/1, positive end expiratory pressure (PEEP) minimum 5 cmH20 and higher during laparoscopy in obese patients, Inspiratory oxygen concentration (FIO2) max 80% during induction and max 40 % during maintenance and extubation. Extubation in an awake, full NMB reversed patient getting no opioids while giving continuous positive airway pressure (CPAP) during withdrawal of the tube. Lung recruitment maneuver (LRM) when lung compliance decreases below 40 milliliter per centimeter water. (ml/cmH2O)

Eligibility criteria: Inclusion Criteria:

* bariatric surgery
* morbid obesity ( BMI \> 35)

Exclusion Criteria:

* patients with pre existing severe cardio-pulmonary diseases having oxygen saturation without oxygen below 94%.

Primary outcomes:
measure: postoperative oxygen saturation
timeFrame: up to maximum 4 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Brugge
country: Belgium
facility: Azsintjan
Study officials:
affiliation: AZSint Jan AV
name: Jan Paul Mulier
role: PRINCIPAL_INVESTIGATOR
References: