louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03120260: Comparing Effect of Short Sleep Duration on Weight Loss of Overweight and Obese Women Attending a Weight Loss Program
Official title: Comparing the Effect of Short Sleep Duration on Weight Loss of Overweight and Obese Women Attending a Weight Loss Program: A 12 Week Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Overweight
Keywords: Caloric Restriction
weight loss
sleep
Lead sponsor: Novindiet Clinic
Sponsor class: OTHER
Collaborators: name: University of Nottingham
name: Tehran University of Medical Sciences
First posted: 2017-04-19
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the present study is to evaluate the effect of sleep duration on weight loss of obese and overweight adult when they are in a weight loss plan (NovinDiet Protocol). The investigators aim is to compare the effects of short term sleep duration with normal sleep duration with respect to body weight (and abdominal adiposity).


Eligibility criteria: Inclusion Criteria:

* Must be female
* Must have \< 7 hour sleep per night
* Must be 18-45 years of age.
* Must have Body mass index (BMI) between 27-35 kg/ m².
* Must be able to have moderate exercise.
* Must be interested to have weight loss.

Exclusion Criteria:

* Participating in a research project involving weight loss or physical activity in the previous six months.
* Pregnancy or lactation during the previous 6 months, or planned pregnancy in the next six months.
* Taking medication that could affect metabolism or change body weight.
* Report heart problems, chest pain, and cancer within the last five years.
* Smoking
* Menopause
* Diagnosis of any chronic disease such as fatty liver, cancer, chemo/radio therapy, heart disease, immune compromised conditions, abnormal thyroid hormone level.

Primary outcomes:
measure: weight loss
timeFrame: 12 Weeks
Secondary outcomes:
measure: Body mass index reduction
timeFrame: 12 Weeks
measure: Fasting plasma glucose level
timeFrame: 12 Weeks
measure: lipid profiles
timeFrame: 12 Weeks
measure: Insulin resistance (HOMA)
timeFrame: 12 Weeks
measure: liver enzymes (SGOT, SGPT)
timeFrame: 12 Weeks
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: NovinDiet Clinic
Study officials:
References:
Clinical trial NCT03529760: Chemotherapy Efficacy and Follow-up Study of Hepatitis B Virus Infection and Reactivation in Children With Leukemia
Official title: Chemotherapy Efficacy and Follow-up Study of Hepatitis B Virus Infection and Reactivation in Children With Leukemia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Reactivation of Hepatitis B Virus
Keywords: Leukemia, occult hepatitis B virus infection
Lead sponsor: Children's Hospital of Chongqing Medical University
Sponsor class: OTHER
First posted: 2018-05-18
Enrollment: 600
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1-16-year-old leukemia hospitalized chemotherapy children

Brief summary: Children with clinically diagnosed leukemia may experience occult HBV infection after chemotherapy immunosuppressive therapy, which may affect the normal course of leukemia treatment. However, this is not caused by clinically relevant diagnosis and treatment measures but exists in vivo.

Detailed description: The clinical diagnosis of children with leukemia may be due to the influence of leukemia disease on the immune cells of the children and the damage to the immune system due to immunosuppressive therapy in children. Therefore, the risk of contracting hepatitis B virus is relatively high, and some children are In the treatment of immunosuppressive chemotherapy (later), the reactivation of occult HBV infection has an impact on the normal course of leukemia treatment. However, this is not a clinically relevant diagnosis and treatment measure. It is necessary to avoid unnecessary conflicts between clinical doctors and patients as much as possible.

Eligibility criteria: Inclusion Criteria:

The clinical diagnosis of children with leukemia received systemic chemotherapy.

Exclusion Criteria:

Children with non-leukemia and children without appropriate treatment.

Primary outcomes:
measure: HBV-DNA positive
timeFrame: 1-year
Secondary outcomes:
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Chongqing Children's Hospital of Chongqing Medical University
state: Chongqing
Study officials:
affiliation: Chongqing Children's Hospital of Chongqing Medical University
name: Yao Zhao
role: STUDY_DIRECTOR
References:
Clinical trial NCT06881160: Mi-RNA and COVID-19
Official title: Circulating Mi-RNA Associated With Disease Severity and Outcome in COVID-19 Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: COVID-19
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2025-03-18
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted at the Fondazione Policlinico Gemelli IRCCS hospital with Covid-19 were enrolled. Peripheral blood samples were collected at the time of hospital admission. Plasma were separated from whole blood by centrifugation for 15 min at 3.000 rpm at 4°C and stored at -80°C until processing

Brief summary: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the cause of coronavirus disease 2019 (COVID-19), induces a spectrum of clinical conditions ranging from asymptomatic infection to life threatening severe disease, characterized by respiratory failure, shock and multi-organ dysfunction requiring admission in the intensive care unit (ICU).

The aim of the present study is to analyze miRNAs associated with SARS-CoV-2 infection, disease severity and mortality.


Eligibility criteria: Inclusion Criteria:

* 18 years
* diagnosis of SARS-CoV-2 infection confirmed by molecular testing on nasopharyngeal swabs

Exclusion Criteria:

* pregnant women

Primary outcomes:
measure: Severity of Covid-19
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS
state: RM
Study officials:
References:
Clinical trial NCT01626560: The Effects of Daptomycin and Cytokines Production in Comparison With Vancomycin
Official title: Effects of Daptomycin in the Levels of IL-1, IL-6 and TNF in Patients With Complicated Cellulitis/Erisipela in Comparison With Vancomycin or Oxacillin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cellulitis
Lead sponsor: Hospital Universitario Evangelico de Curitiba
Sponsor class: OTHER
First posted: 2012-06-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Primary: To determine the influence of daptomycin on inflammatory cytokine (IL-1, TNF and IL-6) for the treatment of complicated cellulitis/erysipela compared with alternative treatment (vancomycin or oxacillin). Secondary: To evaluate the clinical outcome of both groups according to levels of the cytokines evaluated.


Eligibility criteria: Inclusion Criteria:

1. Eligible patients will be age between 18 and 65 who required hospitalization and parenteral antimicrobial therapy
2. Clinical documentation of cellulitis / erysipela
3. Documentation of a minimal surface area 75 cm2 based on the length and / or width of the redness, swelling and / or induration
4. Documented fever, defined as oral or tympanic temperature greater than or equal to 38 ° C

Exclusion Criteria:

1. Infections and other minor addition of erysipelas / cellulitis
2. Any recent use of antibacterial drug therapy (systemic or topical antibacterial drugs within 14 days of enrollment)
3. Patients with clinical conditions that alter the interpretation of the primary outcome as patients with neutropenia or compromised immune function, as HIV infection, autoimmune disorders, use of corticosteroids.
4. Patients with known or suspected osteomyelitis.
5. Patients with suspected or confirmed septic arthritis.
6. Patients with complicated skin infections, such as diabetic foot infections. 7. Chronic use of antipyretic drugs (eg, daily use of naproxen).

8. Less than 18 years of age. 9. pregnancy 10. Patients with mixed infections of Gram-negative or be deleted since the therapy of gram-negative can influence the levels of cytokines.

11. Patients with renal clearance \<30 mL / min. 12. Patients who are not susceptible to daptomycin or vancomycin. 13. Allergy to study medication.

Primary outcomes:
measure: Cytokine levels
timeFrame: AUC will be calculated with multiple time points over a period of 14 days (0, 4, 8, 12 , 16, 24, 48, 72, 96, 120 and 168 hours post-dose)
Secondary outcomes:
Other outcomes:
Locations:
city: Curitiba
country: Brazil
facility: Hospital Universitário Evangelico de Curitiba
state: Parana
Study officials:
References:
Clinical trial NCT05664360: Incidence and Outcomes of Emergency Department Patients Requiring Emergency General Surgery
Official title: Incidence and Outcomes of Emergency Department Patients Requiring Emergency General Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Emergency General Surgery
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2022-12-23
Enrollment: 310914
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients visiting the emergency department

Brief summary: The objectives of this study were (1) to estimate the incidence of emergency general surgery in a Swiss University Hospital, (2) to describe the characteristics and outcomes of patients undergoing such interventions, and (3) to study the impact of age on the outcomes.


Eligibility criteria: Inclusion Criteria:

- consecutive patients visiting the emergency department

Exclusion Criteria:

* admitted primarily for a psychiatric reason
* left without consultation

Primary outcomes:
measure: Incidence of emergency general surgery
timeFrame: Day 3
Secondary outcomes:
measure: Admission to intensive care unit rate
timeFrame: During index hospitalization
measure: ICU length of stay
timeFrame: During index hospitalization
measure: 30-day mortality rate
timeFrame: 30 days
measure: 90-day mortality rate
timeFrame: 90 days
measure: One-year mortality rate
timeFrame: One year
measure: Hospital length of stay
timeFrame: During index hospitalization
measure: Rate of patient dependent at discharge
timeFrame: Hospital discharge
Other outcomes:
Locations:
Study officials:
affiliation: Genava University Hospitals
name: Christophe A Fehlmann, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01674660: Factors Associated With Interdialytic Blood Pressure Variability in Maintenance Hemodialysis Patients
Official title: Factors Associated With Interdialytic Blood Pressure Variability in Maintenance Hemodialysis Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Kidney Failure, Chronic
Keywords: hemodialysis
blood pressure variability
volume status
Lead sponsor: Beijing Chao Yang Hospital
Sponsor class: OTHER
First posted: 2012-08-29
Enrollment: 100
Sex: ALL
Minimum age (years): 24
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: hemodialysis patients of Beijing Chaoyang Hospital

Brief summary: The purpose of this study is to explore the factors associated with interdialytic blood pressure variability in maintenance hemodialysis patients, especially the association between volume status and blood pressure variability.

Detailed description: Hemodialysis patients experience higher rates of cardiovascular morbidity and mortality than the general population and many populations with other chronic diseases. This exceptional risk is explained in part by known risk factors such as diabetes, hypertension, and other uremia-related factors, including vascular calcification and stiffness, autonomic dysfunction, and a high burden of circulating inflammatory mediators. However, additional unidentified risk factors also likely contribute to the disproportionately high prevalence of cardiovascular morbidity in hemodialysis patients. Blood pressure variability may represent one plausible cardiovascular risk factor. Data from nonuremic human populations show an association between greater blood pressure variability and cardiovascular events,nonfatal cardiovascular events,stroke,and increased left ventricular mass. There has been comparatively little work examining the causes and effects of blood pressure variability in hemodialysis populations. So the purpose of this study is to explore the factors associated with interdialytic blood pressure variability in maintenance hemodialysis patients, especially the association between volume status and blood pressure variability.

Eligibility criteria: Inclusion Criteria:

* age 18 years or older
* receipt of thrice-weekly in-center hemodialysis
* no anticipation of imminent(\<6 months)living related kidney transplant
* not transfer of care to a nonparticipating facility
* no dialytic modality change
* free of vascular, infectious, or bleeding complication within 1 month Exclusion Criteria:
* who missed \>2 hemodialysis treatments over 1 month
* abused drugs
* severe anemia，malnutrition，chronic atrial fibrillation
* body mass index of 40 \>kg/m2

Primary outcomes:
measure: interdialytic blood pressure
timeFrame: 44 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Nephrology, dialysis center,Beijing Chaoyang Hospital
state: Beijing
Study officials:
affiliation: Beijing Chao Yang Hospital
name: Ma WH weihua, Master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05952960: Optimizing Open Label Placebo Rationales
Official title: Optimizing Open Label Placebo Rationales for Chronic Pain
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Pain
Lead sponsor: Rhode Island Hospital
Sponsor class: OTHER
First posted: 2023-07-19
Enrollment: 30
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: A 3-arm randomized trial where all chronic pain patients will receive honest placebos, but the information about the placebos will differ between conditions. Outcomes are measured for 21 days and a qualitative survey will be conducted.


Eligibility criteria: Inclusion Criteria:

* chronic pain
* 18 years old
* English speaking
* have a smartphone or computer with video access
* Taking prescription opioids for chronic pain
* the chronic pain is concentrated into the patient's lower back.

Exclusion Criteria:

* suspect an allergy to any placebo ingredient
* problematic substance use
* cancer diagnosis causing pain
* anticipated change in opioid script during the study period.

Primary outcomes:
measure: Pain Reports
timeFrame: 21 days
Secondary outcomes:
measure: Opioids
timeFrame: 21 Days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04894760: Evaluation of a COVID-19 Rapid Diagnostic Test in ER Departments in Mexico: a Multi-center Study
Official title: Evaluation of a Rapid Diagnostic Test of SARS-COV-2 Carried Out in the Emergency Units of Reference Hospitals in Mexico and in Primary Care: Multi-center Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Keywords: rapid test
diagnosis
antigen test
Lead sponsor: National Institute of Respiratory Diseases, Mexico
Sponsor class: OTHER_GOV
First posted: 2021-05-20
Enrollment: 567
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients that arrive to the ER department of each reference center.

Brief summary: An observational (cross-sectional) study in the emergency services of participating hospitals, receiving patients with COVID-19 and influenza, aiming to evaluate the diagnostic performance of the rapid antigen detection test for COVID-19 both in nasal sampling and saliva, in patients attending emergency services in the 2020-2021 winter season, performed on site, compared to the gold standard (RT-qPCR).

Detailed description: This study aims to analyze the usefulness of rapid tests, especially: a) as a diagnostic test in people attending care for nonspecific, respiratory symptoms, in emergency services of referral hospitals b) as a diagnostic test in contacts of known patients. c) as a diagnostic test to differentiate influenza from COVID-19 in the circumstance of an overlap of both viruses in the community. d) In the 3 cases, the gold standard would be the RT-PCR test for influenza and for SARS-COV-2 performed in the usual laboratory following the officially approved technique in Mexico. If the test were in saliva, it would also be much more accepted and could come close to performing a test at home that would greatly facilitate the diagnosis. So it is important to see the performance of a saliva test.

As an observational (cross-sectional) study in the emergency services of participating hospitals, receiving patients with COVID-19 and influenza, aiming to evaluate the diagnostic performance of the rapid antigen detection test for COVID-19 both in nasal sampling and saliva, in patients attending emergency services in the 2020-2021 winter season, performed on site, compared to the gold standard (RT-qPCR).

Eligibility criteria: Inclusion Criteria:

* At least 18 years of age
* Signed Informed consent
* Emergency room visit or screening site with respiratory symptoms consistent with COVID-19 / influenza.

Exclusion Criteria:

* Positive pregnancy test
* Lactation
* Decision of the responsible physician to remove patient from the study.
* Transfer of the patient to another hospital unit

Primary outcomes:
measure: Diagnostic accuracy
timeFrame: At 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico, City
country: Mexico
facility: Instituto Nacional de Enfermedades Respiratorias, "Ismael Cosío Villegas"
Study officials:
References:
Clinical trial NCT01545960: Evaluating Acupuncture Points With Scanning Kelvin Probe
Official title: Scanning Kelvin Probe Measurements of Acupuncture Point
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Healthy Individuals
Acupuncture Points
Electrical Potential
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2012-03-07
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy volunteers

Brief summary: The purpose of this study is to characterize the surface electrical potential of acupuncture points with a Scanning Kelvin Probe.

Detailed description: Acupuncture points are anatomical structures described by traditional Chinese medicine. To this day, however, their scientific and Western anatomical characterizations remain unclear. Past studies have suggested that acupuncture points are distinct electrically (increased electrical conductivity). To evaluate this claim, this study uses a Scanning Kelvin Probe to study the electrical potential of three acupuncture points and their respective adjacent controls in 24 healthy individuals. The Scanning Kelvin Probe is a novel device that measures the electrical potential of skin without actually touching the skin surface.

Eligibility criteria: Inclusion Criteria:

* Individuals without chronic medical condition requiring daily medications (hypertension, diabetes, hypothyroidism, etc).

Exclusion Criteria:

* Individuals with autonomic disorders (sweating irregularities), skin disorders, extensive burns/scars on the hand, tremors, neuromuscular conditions, restless leg syndrome, movement disorders, and implanted cardiac defibrillator/pacemaker

Primary outcomes:
measure: Electrical Potential at Acupuncture points
timeFrame: One day
Secondary outcomes:
Other outcomes:
Locations:
city: Charlestown
country: United States
facility: Massachusetts General Hospital - Martinos Center for Biomedical Imaging
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Andrew C. Ahn, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06184360: Real-world Evaluation of BEOVU (Brolucizumab) Effectiveness and Durability for Treatment of Neovascular (Wet) Age-related Macular Degeneration (AMD)
Official title: Real-world Evaluation of BEOVU (Brolucizumab) Effectiveness and Durability for Treatment of Neovascular (Wet) Age-related Macular Degeneration (AMD)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neovascular (Wet) Age-related Macular Degeneration
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2023-12-28
Enrollment: 2079
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: This was a retrospective, noninterventional cohort study.

Brief summary: This was a retrospective, observational cohort study. Data were analyzed from the Intelligent Research in Sight (IRIS) registry from October 8, 2019, through November 26, 2021, with a follow-up period of 12 months following the first brolucizumab injection (index date).


Eligibility criteria: Inclusion Criteria:

* At least 18 years old at the time of their first (index) injection of brolucizumab.
* Had documented neovascular age-related macular degeneration (nAMD) on or within 3 years before the index injection.
* Used only brolucizumab for at least 12 months (± 45 days) after the index injection, with at least 1 brolucizumab injection given within the first 6 months after the index injection and at least 1 additional brolucizumab injection given at 6-12 months after the index injection.

Exclusion Criteria:

* Had received any other anti-VEGF agent between the index injection and 12-month follow-up.
* Lacked information about the laterality of disease at the time of the index injection.
* Lacked visual acuity assessments on or within 30 days before the index injection or at 6, 9, and 12 months after the index injection (all of the latter ± 45 days).

Primary outcomes:
measure: Change in Best Recorded Visual Acuity, Stratified by Prior Treatment Status
timeFrame: Baseline up to 12 months
measure: Change in Injection Interval at 12 Months of Brolucizumab Treatment Compared with Prior Anti-vascular Endothelial Growth Factor (VEGF) Treatment
timeFrame: Baseline up to 12 months
measure: Number of eyes with adverse events
timeFrame: Baseline up to 12 months
measure: Time to adverse event
timeFrame: Baseline up to 12 months
measure: Number of brolucizumab injections prior to adverse event
timeFrame: Baseline up to 12 months
Secondary outcomes:
measure: Brolucizumab Injection Interval and Interval Extension, Stratified by Pre-Switch Interval
timeFrame: Baseline up to 12 months
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis
state: New Jersey
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: