louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01484288: Baroreflex Activation Therapy in Heart Failure
Official title: Baroreflex Activation Therapy in Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Lead sponsor: CVRx, Inc.
Sponsor class: INDUSTRY
First posted: 2011-12-02
Enrollment: 12
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical investigation is to evaluate the efficacy and safety of the CVRx Barostim Neo System in the treatment of patients with heart failure.


Eligibility criteria: Inclusion Criteria:

* Age at least 21 years
* Symptomatic heart failure despite optimal, stable pharmacological therapy for at least 4 weeks

Exclusion Criteria:

* Significant carotid plaque or stenosis
* Known or suspected baroreflex failure or autonomic neuropathy
* Myocardial infarction, unstable angina, syncope, cerebral vascular accident, SCD, or received defibrillation therapy within the past 3 months
* Heart failure secondary to a reversible condition

Primary outcomes:
measure: Changes in Sympathetic Nervous System Activity (MSNA Bursts/Min)
timeFrame: 6 months
measure: Changes in Sympathetic Nervous System Activity (MSNA Bursts/100 Heartbeats)
timeFrame: 6 months
Secondary outcomes:
measure: Change in Systolic Blood Pressure
timeFrame: 6 months
measure: Change in Diastolic Blood Pressure
timeFrame: 6 months
measure: Change in Heart Rate
timeFrame: 6 months
measure: Change in Six-Minute Hall Walk
timeFrame: 6 months
measure: New York Heart Association (NYHA) Class
timeFrame: Six months
measure: Change in Quality of Life (Minnesota Living With Heart Failure Questionnaire)
timeFrame: Six months
measure: Change in Left Ventricular Ejection Fraction (LVEF)
timeFrame: Six months
Other outcomes:
Locations:
city: Milan
country: Italy
facility: MultiMedica
Study officials:
affiliation: MultiMedica
name: Edoardo G Gronda, MD, FESC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03380988: Fiber-enriched Buckwheat Pasta and Glucose Variability in Patients With Type 1 Diabetes and Celiac Disease
Official title: Fiber-enriched Buckwheat Pasta Reduces Daily Glucose Variability in Patients With Type 1 Diabetes and Celiac Disease: an Acute Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Celiac Disease
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2017-12-21
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The intervention was preceded by a 1-week run-in period during which participants underwent continuous glucose monitoring (CGM) and filled in a 7-day dietary record to optimize basal infusion rate and insulin-to-glycemic load ratio. The study had a randomized crossover design with each subject studied on 2 occasions at least 1 week apart. Participants were assigned to consume, in random order, two test meals with the same amount of carbohydrates (50g): a meal containing fiber-enriched buckwheat pasta (FBP) or corn pasta (CP), used as control. Over the experimental period, participants underwent CGM, wearing their sensors 7 days/week.


Eligibility criteria: Inclusion Criteria:

* Age: 20-50 years
* Documented history of celiac disease and type 1 diabetes.

Exclusion Criteria:

* Pregnancy/breast feeding
* Serious microvascular and macrovascular diabetes complications
* Any other chronic or acute disease apart from diabetes seriously affecting health status

Primary outcomes:
measure: Postprandial glucose response
timeFrame: 6 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Department of Clinical Medicine and Surgery
Study officials:
References:
Clinical trial NCT04310488: Assessment of Effects of Museum Prescription of A Montreal Museum of Fine Arts Visit Tour in Primary Care Patients
Official title: Assessment of Effects of Museum Prescription of A Montreal Museum Of Fine Arts Visit Tour in Primary Care Patients: a Cross-Sectional Study
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Museum
Mental Health
Quality of Life
Health, Subjective
Keywords: Museum
Art
Lead sponsor: Jewish General Hospital
Sponsor class: OTHER
First posted: 2020-03-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Montreal Museum of Fine Arts visitors

Brief summary: The objective of this study is to examine effects on mental and physical health and quality of life in primary care patients visiting the Montreal Museum of Fine Arts (MMFA), this visit being prescribed by their physician. To visit the MMFA and to complete after this visit a series of self-administered questionnaires within the two days after their visit at the museum

Detailed description: During the past decade, museums have become involved in the care of patients by using art to improve their quality of life and well-being. Museums have, thus, emerged as new partners in public health. Very few programs developed by museums have focused on primary care patients who are a target audience for museum health program preventions. For the development of appropriate museum programs based on visit tour, there is a need to improve knowledge the effects of a museum visit prescribed by a primary care physician in patients. The objective of this study is to examine effects on mental and physical health and quality of life in primary care patients visiting the Montreal Museum of Fine Arts (MMFA), this visit being prescribed by their physician. Based on a cross-sectional study it will be prescribed to all patients consulting their primary care physician to visit the MMFA and to complete after this visit a series of self-administered questionnaires within the two days after their visit at the museum. The period of recruitment will be one year. The outcomes are the scores of the different questionnaires.

Eligibility criteria: Inclusion Criteria:

1. ≥ 18 years old
2. Home Internet access with an electronic device (computer, pad or cellular phone)
3. Patient without dementia
4. Speak the language of the recruitment centre (French or English)

Exclusion Criteria:

1. dementia
2. participation refusal

Primary outcomes:
measure: Socio-demographic characteristics from the primary care physician questionnaire
timeFrame: 1 day
measure: Mental health condition from the primary care physician questionnaire
timeFrame: 1 day
measure: Physical health condition
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Jewish General Hospital
state: Quebec
Study officials:
References:
Clinical trial NCT01857778: Breast Tissue Before And After Breastfeeding Or The Use Of A Breast Pump
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: To Collect Measurements of the Nipple
To Record Clinical Observations of the Nipple, Areola, and Breast Tissue Before and After Breastfeeding
To Record Clinical Observations of the Nipple, Areola, and Breast Tissue Before and After Expressing Milk With 3 Different Electric Breast Pumps.
Keywords: Breastfeeding
Breast tissue
Breast pump
Lead sponsor: Foundation for Maternal Infant and Lactation Knowledge
Sponsor class: OTHER
First posted: 2013-05-20
Enrollment: 28
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Lactating women.

Brief summary: There will be breast tissue changes after use of a breast pump.


Eligibility criteria: Inclusion Criteria:

* Lactating women who were breastfeeding.

Exclusion Criteria:

* Non breastfeeding or non lactating women.

Primary outcomes:
measure: Breast Tissue Change
timeFrame: 10 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Reno
country: United States
facility: Renown Medical Center
state: Nevada
Study officials:
affiliation: Foundation for M.I.L.K.
name: Dr. Jimi Francis, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01623778: Optimization of Antiviral Therapy of Chronic HBV Infection
Official title: Observation Study of Different Optimized Therapy Method of Patients With Chronic Hepatitis B
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Australia Antigen Positive
Hepatitis B
Adverse Effects
Keywords: HBeAg seroconversion
Peginterferon alfa-2a
chronic hepatitis B(CHB
Optimal therapy
Response guild treatment(RGT);
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2012-06-20
Enrollment: 67
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: cases of HBeAg-positive CHB with inadequate response to 24 weeks Peg interferon alpha-2a were enrolled.

Brief summary: Along with the improvement of the accuracy of detection of HBV serological markers, the optimization of antiviral therapy for patients with chronic hepatitis B (CHB) infection becomes feasible. Currently, the recommendation of optimized treatment especially interferon therapy are mainly based on retrospective studies, it still lacks prospective evidence. This study is aimed to evaluate the efficacy, safety and pharmacoeconomics benefits of 48 weeks optimized interferon therapy (switch to telbivudine or plus adefovir dipivoxil) for HBeAg positive CHB with inadequate response to 24 weeks interferon treatment.

Detailed description: Patients with inadequate response to interferon therapy at 24 weeks were enrolled in this study and accepted the optimized therapy (add on ADV or switch to LDT) for 48weeks. All these patients were followed for 48 weeks and the HBeAg seroconversion and HBV DNA level were observed. Safety and the economic effect of the two optimized therapy methods also were observed.

Eligibility criteria: Inclusion Criteria:

patients receiving Peg interferon α-2a with inadequate response at 24 weeks (HBeAg titer ≥ 100Paul Ehrlich Institute Unit (PEIU)/ml and HBV DNA ≥ 5.0 Log copies/ml or HBV DNA titer decline \<1 Log copies/ml) were enrolled into this study.

Exclusion Criteria:

* no decompensated cirrhosis,
* no hepatitis C, hepatitis D or human immunodeficiency virus (HIV) co-infection,
* no hepatocellular carcinoma and other tumors or history of severe hepatitis,
* no other systems diseases, such as a history of cardiopulmonary diseases, thyroid disorders, immune system disorders, epilepsy or mental illness (such as severe depression).

Primary outcomes:
measure: HBeAg seroconversion rate
timeFrame: 48weeks
Secondary outcomes:
measure: HBV DNA decline
timeFrame: 48weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai hospital
state: Shanghai
Study officials:
affiliation: Changhai Hospital affiliated to the Second Military Medical University
name: Wan Mo Bin, Dr
role: STUDY_DIRECTOR
References:
Clinical trial NCT01550978: Evaluation of the Safety and Efficacy of the AnapnoGuard 100 System
Official title: The Safety of Using the AnapnoGuard 100 System in Intubated Critical Care Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation Complications
Lead sponsor: Hospitech Respiration
Sponsor class: INDUSTRY
First posted: 2012-03-12
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to evaluate the safety of using the AnapnoGuard 100 system during the course of mechanical ventilation and intubation of critical care patients in Intensive Care Unit.


Eligibility criteria: Inclusion Criteria:

* Age above 21 (men and women);
* Patient is admitted to ICU and expected to receive mechanical ventilation for more than 12 hours
* Absence of clear signs of pneumonia and lung contusion on chest X ray;
* For study patients, connection of the ETT to the AnapnoGuard system less than 6 hours from intubation initiation;
* No fever or fever from a known non chest/lung origin;

Exclusion Criteria:

* Patients who had been treated with mechanical ventilation during the last 3 months;
* Patients with facial, oropharyngeal or neck trauma
* BMI \> 40
* Pregnant women
* Patients ventilated in prone position
* Difficult intubation (defined as more than 3 intubation attempts)

Primary outcomes:
measure: Rate of AE (adverse events) and SAE (serious adverse events)
timeFrame: participants will be followed for the entire duration of intubation (an expected average of 8 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Policlinico Universitario A. Gemelli
Study officials:
affiliation: Director of General ICU and Institute of Anesthesiology and Intensive Care, Policlinico Universitario A. Gemelli
name: Massimo Antonelli, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: De Pascale G, Pennisi MA, Vallecoccia MS, Bello G, Maviglia R, Montini L, Di Gravio V, Cutuli SL, Conti G, Antonelli M. CO2 driven endotracheal tube cuff control in critically ill patients: A randomized controlled study. PLoS One. 2017 May 11;12(5):e0175476. doi: 10.1371/journal.pone.0175476. eCollection 2017.
Clinical trial NCT05423678: Clinical Trial - Analyzing Participation Experiences Of Amyotrophic Lateral Sclerosis Patients
Official title: In Depth Observational Clinical Trial - Analyzing Participation Experiences Of Amyotrophic Lateral Sclerosis Patients
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: ALS
Amyotrophic Lateral Sclerosis
Keywords: als
als clinical trials
als diversity studies
amyotrophic lateral sclerosis
Lead sponsor: Power Life Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2022-06-21
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Amyotrophic Lateral Sclerosis patients who are actively considering enrolling in an interventional clinical trial, but have not yet completed enrollment and registration.

Brief summary: Clinical trial participation has always been substantially skewed toward certain demographic groups. However, there has been little study on whether trial qualities impact participation in either a positive or negative way. The goal of this research is to identify the characteristics that consistently restrict patients' ability to participate in or complete a trial in which they were initially interested. This data will be analyzed via a number of demographic lenses in order to find trends that could benefit future ALS sufferers.


Eligibility criteria: Inclusion Criteria:

* Lives in the United States
* Is 18+ years old
* Participant has a diagnosis of Amyotrophic Lateral Sclerosis (ALS)
* Participant has enrolled in an interventional clinical for ALS (self-reported)

Exclusion Criteria

* Inability to perform regular electronic reporting
* Patient does not understand, sign, and return consent form
* No diagnosis of Amyotrophic Lateral Sclerosis (ALS) confirmed

Primary outcomes:
measure: Number of patient decides to enroll in clinical trial
timeFrame: 3 months
measure: Rate of patients who remain in clinical trial to trial completion
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Power Life Sciences Inc.
name: Michael B Gill
role: STUDY_DIRECTOR
References:
citation: Chio A, Canosa A, Gallo S, Cammarosano S, Moglia C, Fuda G, Calvo A, Mora G; PARALS group. ALS clinical trials: do enrolled patients accurately represent the ALS population? Neurology. 2011 Oct 11;77(15):1432-7. doi: 10.1212/WNL.0b013e318232ab9b. Epub 2011 Sep 28.
citation: Sabatelli M, Conte A, Zollino M. Clinical and genetic heterogeneity of amyotrophic lateral sclerosis. Clin Genet. 2013 May;83(5):408-16. doi: 10.1111/cge.12117. Epub 2013 Mar 12.
citation: Powell JH, Fleming Y. Making medicines for America: the case for clinical trial diversity. J Natl Med Assoc. 2000 Nov;92(11):507-14. No abstract available.
Clinical trial NCT04888078: Bassini Inguinal Hernia Repair: Obsolete Or Still A Viable Surgical Option?
Official title: Incidence of POUR in the Veteran Population After Elective Inguinal Hernia Repair: A Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inguinal Hernia
Surgery--Complications
Surgical Complication
Lead sponsor: Hunter Holmes Mcguire Veteran Affairs Medical Center
Sponsor class: FED
First posted: 2021-05-17
Enrollment: 203
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Veterans who underwent inguinal hernia repair without mesh

Brief summary: Retrospective review of hernia surgery patients at HHMcGuire VAMC focusing on repair type and postoperative complications.


Eligibility criteria: Inclusion Criteria: Inguinal hernia repair without mesh -

Exclusion Criteria: Mesh repair

-

Primary outcomes:
measure: Inguinal hernia recurrence
timeFrame: 5-13 years postoperatively
Secondary outcomes:
measure: wound infection
timeFrame: 5-13 years
measure: urinary retention
timeFrame: 5-13 years
measure: groin pain
timeFrame: 5-13 years
measure: durability of repair
timeFrame: 5-13 years postop
measure: testicular ischemia
timeFrame: 5-13 years
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Hunter Holmes McGuire VAMC
state: Virginia
Study officials:
References:
Clinical trial NCT05112978: Evaluation of Patellar Dimension and Bristol Index in Asian Population
Official title: Evaluation of Patellar Dimension and Bristol Index in Asian Population: an MRI Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patello Femoral Syndrome
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2021-11-09
Enrollment: 101
Sex: ALL
Minimum age (years): 17
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: all patients came to clinic

Brief summary: Restoration of patellar thickness is pivotal during a total knee arthroplasty (TKA). Several studies showed there are differences in the knee measurements between Asian and Western population. This study aims to evaluate the patellar dimension and Bristol Index of patellar width to thickness (BIPWiT) using magnetic resonance imaging (MRI) in Asian population.


Eligibility criteria: Inclusion Criteria:

* knee pain

Exclusion Criteria:

* degenerative joint disease
* patellofemoral pathology

Primary outcomes:
measure: bristol index
timeFrame: 1 day MRI examination
Secondary outcomes:
measure: patellar sizes
timeFrame: 1 day MRI examination
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Pondok Indah Hospital
Study officials:
References:
Clinical trial NCT06288178: The Effect of Consumption of Bread Types Made From Various Flours on Blood Glucose Fluctuations
Official title: The Effect of Consumption of Bread Types Made From Various Flours on Blood Glucose Fluctuations in Individuals With Obesity and Normal-Weight: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Glycemic Index
Blood Glucose
Bread
Keywords: obesity
Glycemic index
Blood glucose
Cornbread
Buckwheat bread
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2024-03-01
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The obesities were aimed at the effect of whole wheat (WWB), buckwheat (BWB), and cornbread (CB) on blood glucose by comparing the glycemic index values with reference bread (RB).

Overall, WWB consumption had a positive effect on blood glucose in individuals with obesity, while BWB consumption caused an increase in blood glucose levels.


Eligibility criteria: Inclusion Criteria:

* The study group consisted of volunteer individuals aged between 18 and 35 years.
* The first blood glucose measurement was taken after at least 8 hours of fasting and any of the bread types were given to the participants for consumption.
* All measurements were taken between 09.00-13.00.
* During the measurements, the volunteers were observed to avoid water, coffee, and any food intake and to avoid excessive exercise.

Exclusion Criteria:

* Pregnant,
* lactating women
* patients with physician-diagnosed chronic diseases
* Medication use

Primary outcomes:
measure: One loaf of bread was been consumed every week. Blood glucose measurements were performed with a glucometer at 0 (fasting), 30, 60, 90, and 120 minutes after each bread consumption.
timeFrame: Within research completion, an average of 4 week
Secondary outcomes:
measure: This classification as obese and normal-weight individuals was made with the BIA (Bioelectrical impedance analysis) method. This classification was understood by anthropometric measurements made in the first week.
timeFrame: Within research completion, an average of 1 week
Other outcomes:
Locations:
city: Trabzon
country: Turkey
facility: Avrasya University
Study officials:
References: