louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04892810: Immunomonitoring of Interventional Radiology Procedures in the Management of Hepatocellular Carcinoma
Official title: Immunomonitoring of Interventional Radiology Procedures in the Management of Hepatocellular Carcinoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatocellular Carcinoma
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2021-05-19
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients older than 40 years old that can benefit for ablation (either RFA or MWA) for HCC

Brief summary: This cohort study compares immune response induced in two groups of small HCC patients treated by ablation (group1 RFA, group 2 MWA). Patients will benefit for tumoral and non tumoral biopsies prior to treatment and stepped peripheral blood samples juste before ablation and during the first month after.


Eligibility criteria: Inclusion Criteria:

* Histologically proven HCC for less than 3 months before ablation
* Decision of ablation treatment in multidisciplinary meeting

Exclusion Criteria:

* Fibrolamellar HCC
* Hepatocholangiocarcinoma

Primary outcomes:
measure: To compare induced immunomodulation by RFA and MWA in HCC patients
timeFrame: one month
Secondary outcomes:
measure: To evaluate early induced immunomodulation after RFA in HCC patients
timeFrame: one month
measure: To evaluate early induced immunomodulation after MWA in HCC patients
timeFrame: one month
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03412110: (MIST2)-Part2: AEs Following DC Care at DC Teaching Clinic: Electronic
Official title: Assessment & Feasibility of an Electronic Post-Symptoms Evaluation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patient Safety
Manipulation, Spinal
Keywords: chiropractic
SMT
Active surveillance reporting system
Lead sponsor: Parker University
Sponsor class: OTHER
Collaborators: name: Canadian Memorial Chiropractic College
name: University of Alberta
First posted: 2018-01-26
Enrollment: 416
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Each supervising faculty clinician in the Parker Wellness Clinic had data collected from interested patients during a pre-specified one week period of time.

Brief summary: This study aims to compare different ways to establish severity from patients reporting a new or worsening symptom (adverse event) following a chiropractic treatment at a teaching clinic using an electronic platform.

Detailed description: Healthcare systems acknowledge the importance of patient safety including the reduction of preventable adverse events (AE). For healthcare providers who perform spinal manipulation therapy (SMT), the investigation of AEs remains in its infancy for several reasons including finding a reporting system that accurately collects AEs information, varied descriptions of AE's severity and occurrence frequency and the variable natural history of musculoskeletal conditions treated by SMT. Together, these factors act together to conspire against the implementation of systematic changes in SMT application that would result in improved patient care and safety.

In addition, it is vital that patient safety training initiates at the start of a healthcare worker's career. This pilot active surveillance study was designed to assess the feasibility of collecting data with an electronic platform for patients' self-report of symptom changes as well as interns' report at a chiropractic teaching clinic.

Eligibility criteria: Inclusion Criteria:

* Patients at the Parker University Wellness Clinic
* Agreed to participate

Exclusion Criteria:

* none

Primary outcomes:
measure: patient - report of an adverse event
timeFrame: Up to 7 days post treatment - Day 0-7
measure: intern - report of an adverse event
timeFrame: Immediate after treatment - Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Parker University
state: Texas
Study officials:
affiliation: Parker University
name: Katherine A Pohlman, DC, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00739310: Study Assessing High-Frequency Chest Wall Oscillation (HFCWO) in Preventing Pulmonary Exacerbations
Official title: A Pilot Study to Assess the Efficacy and Effectiveness of High-Frequency Chest Wall Oscillation (HFCWO) in Preventing Pulmonary Exacerbations in Children With Muscle Weakness and Restrictive Lung Disease CR-0088
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Palsy
Keywords: High Frequency Chest Wall Oscillation
Cerebral Palsy
Restrictive lung disease
Lead sponsor: Hill-Rom
Sponsor class: INDUSTRY
First posted: 2008-08-21
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: To asssess efficacy of airway clearance provided by Vest therapy (HFCWO) in the reduction of respiratory exacerbations requiring hospitalization or antibiotic utilization in patients with muscle weakness and restrictive lung disease.

Detailed description: This non-randomized home based pre-post intervention study. The study will compare the efficacy of Vest® therapy (HFCWO) for mucus secretion clearance in a population of patients with muscle weakness and restrictive lung disease with frequent pulmonary exacerbations. Enrolled subjects with a tracheostomy will be evaluated for microbial load and inflammatory status as a pilot evaluation of microbial load and inflammatory status outcomes.

The total number of evaluable subjects to be recruited is estimated at 40. Subjects will be considered evaluable if they have completed at least 6 months of follow up.

Eligibility criteria: Inclusion Criteria:

* Subject is at least 18 months old.
* Subject has a chest circumference of greater than 19 inches.
* Subject has a diagnosis of muscle weakness and restrictive lung disease.
* Ability to provide Informed consent from legal guardian.
* Subject has had 2 or more exacerbations requiring either hospitalization or antibiotics (IV or oral) in the past 12 months
* If inhaled Tobramycin has been prescribed prophylacticly, subjects must discontinue the medication at least 2 weeks prior to study enrollment

Exclusion Criteria:

* Subject has a diagnosed allergy with a respiratory trigger.
* Participation in another clinical trial.
* Unstable head or spinal injury.
* Unresolved pneumothorax or pneumomediastinum present
* Unresolved hemorrhage
* Hypotension requiring vasopressors or positioning
* Bronchopleural fistula
* Gross hemoptysis within the past eight hours
* Pulmonary embolism or history of pulmonary embolism within the past two months
* Burns, open wounds and skin infections on the thorax
* Osteomyelitis of the ribs
* Osteoporosis with history of fractures.

Primary outcomes:
measure: Hospitalizations Lasting at Least 24 Hours in This Patient Population
timeFrame: end of study
Secondary outcomes:
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: Maimonides Medical Center
state: New York
Study officials:
affiliation: Maimonides Medical Center
name: Mikail Kazachkov, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03734510: The Effect of Supplementation of Flaxseed, Hesperidin, Flaxseed and Hesperidin Together in Non-alcoholic Fatty Liver Disease: A Randomized, Controlled Study
Official title: Evaluation of the Effects of Supplementation of Flaxseed, Hesperidin, Flaxseed and Hesperidin Together on Hepatic Enzymes, Inflammatory Factors, Lipid Profile, Blood Glucose, Insulin Sensitivity, and Hepatic Steatosis Grade in Patients With Non-alcoholic Fatty Liver Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Non Alcoholic Steatohepatitis
Lead sponsor: National Nutrition and Food Technology Institute
Sponsor class: OTHER
First posted: 2018-11-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To study the effects of Hesperidin, flaxseed and both together on lipid profile, liver enzymes, inflammatory factors and hepatic fibrosis in patients with Nonalcoholic Steatohepatitis (NASH), 100 patients who referred to Gastrointestinal (GI) clinic with steatosis grade 2 and 3 will be randomly allocated to one of following four groups: control group, hesperidin group (2 capsules Hesperidin), flaxseed group (30 gram flaxseed) or flaxseed-hesperidin group (2 capsules Hesperidin and 30 gram flaxseed) for 12 weeks; both groups will be advised to adherence the investigators' diet and exercise program too. At the first and the end of the intervention, lipid profiles, liver enzymes, some inflammatory markers, and liver fibrosis will be assessed and compared between groups.


Eligibility criteria: Inclusion Criteria:

* Age of 18 to 70 years
* Body Mass Index (BMI) between 25-40
* Sonographic findings compatible with hepatic steatosis (degree 2 or more)

Exclusion Criteria:

Diabetes Taking any kind of antibiotics two weeks before recruitment History of alcohol consumption pregnancy or lactation Professional athletes Other liver disease (viral/etc) Use of drugs such as calcium channel blockers, high dose synthetic estrogens, methotrexate , amiodarone, steroids, chloroquine, immunosuppressive drugs, lipid-lowering agents, metformin and vitamin E A history of Hypertension, Cardiovascular disease, Pulmonary disease, Renal disease \& Celiac disease; Cirrhosis History of Upper GI surgery / Prior surgical procedures such as jejunoileal or jejunocolic bypass, gastroplasty Following program to lose weight in recent 3 mo A history of hypothyroidism or Cushing's syndrome

Primary outcomes:
measure: liver fibrosis
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: National Nutrition and Food Technology Research Institute
state: Iran (the Islamic Republic Of)
Study officials:
References:
Clinical trial NCT02929810: Sleep Extension and Blood Pressure
Official title: Lowering Blood Pressure by Sleep Extension: a Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Extension
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2016-10-11
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Emerging evidence suggests that approximately 30% of the US adult population sleeps less than 7 hours per night, and those who do exhibit 20-52% enhanced risk to develop cardiovascular diseases and particularly hypertension. Since sleep curtailment is largely voluntary, sleep deficiency can be corrected and its detrimental health consequences potentially reversed. The purpose of the present proposal is to investigate the cardiovascular and metabolic effects of sleep extension in prehypertensive and stage 1 hypertensive subjects who report habitual short sleep.


Eligibility criteria: Inclusion Criteria:

* Age: 18 to 65 (inclusive)
* Gender: both males and females
* Body mass index (BMI): 18.5-34.9 kg/m2
* Habitual sleep duration: \<7 hours
* Presence of either:

  * Prehypertension: office systolic BP (SBP) 120-139 mmHg and/or diastolic BP (DBP) 80- 89 mmHg;
  * Stage 1 hypertension: office SBP 140-159 mmHg and/or DBP 90-99 mmHg
* Either on no prescription medications (other than oral contraceptive pills, or intrauterine devices) or on stable medical regimen for at least 1 month, if taking prescription medications for chronic conditions
* Not pregnant or breast feeding and not intending to become pregnant or breast feed
* Not a current smoker or tobacco user
* Ability to provide written informed consent

Exclusion Criteria:

* Vulnerable study populations will be excluded
* Pregnancy
* Smoking
* Presence of overt cardiovascular diseases, diabetes, chronic kidney disease, cancer, sleep disorders, psychiatric disorders
* If taking prescription medications for chronic conditions, change in therapy (type, frequency and/or dosage) over the previous month
* Habitual sleep duration ≥7 hours
* Excessive alcohol (≥15 drinks/week in men and ≥8 drinks/week in women) and/or excessive caffeine intake (\>400 mg)
* Currently on a diet and/or actively trying to lose weight
* Currently or previously (during the past 2 months) participation in any other research study at the discretion of study personnel
* Blood/plasma donation during the past 2 months
* Unwillingness or inability to adjust sleep schedule.

Primary outcomes:
measure: change in 24-hour mean arterial pressure
timeFrame: 8 weeks
Secondary outcomes:
measure: change in baroreflex sensitivity
timeFrame: 8 weeks
measure: change in endothelial function
timeFrame: 8 weeks
measure: change in insulin sensitivity
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Virend Somers, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03115710: The K-Map Study, Global Prevalence of KC
Official title: The K-Map Study, Global Prevalence of KC
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Keratoconus
Keywords: Keratoconus
Prevalence
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
Collaborators: name: ELZA Institute
First posted: 2017-04-14
Enrollment: 700
Sex: ALL
Minimum age (years): 6
Maximum age (years): 23
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This project will include children and adolescent age (6 - 23).The rationale for selecting this age range is to detect the disease KC at early stages.

Brief summary: Keratoconus is a ocular disease classified under ectatic diseases which often results in bilateral and asymmetrical corneal distortion. It usually affects patients at young age and can cause severe visual loss.

The overall goal of this study is to assess the prevalence of keratoconus (KC) in children and adolescents in various regions of the world based on modern tomographic imaging methods, and to verify whether the occurrence rates reported from literature should be corrected. Our hypothesis is that the prevalence of the disease is much higher than that traditionally reported.

At each site, corneal tomography examinations (Pentacam) will be performed bilaterally in children and adolescents, who are not ill or with any ophthalmological symptom. The population to be studied will be composed of children and adolescents on medical visits for non-ophthalmologic reasons, aged between 6 and 20 years. Multiple cities, from different continents (North America, South America, Asia and Europe) will participate.


Eligibility criteria: Inclusion Criteria:

* Male or female, 6-23 years of age.
* Subjects seen for a non-ophthalmic appointment
* Provide signed and dated patient consent form (signed by parents / legal guardians).
* Willing to comply with all study procedures and be available for the duration of the study

Exclusion Criteria:

* Patients with a preexisting ocular disease / condition
* Pregnancy or breastfeeding

Primary outcomes:
measure: Prevalence of keratoconus
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC Roski Eye Institute
state: California
city: Wenzhou
country: China
facility: Eye Hospital of Wenzhou Medical College
city: Riyadh
country: Saudi Arabia
facility: King Saud University
Study officials:
affiliation: ELZA Institute
name: Farhad Hafezi
role: STUDY_DIRECTOR
References:
Clinical trial NCT02794610: Ocular Penetration of Topical Tacrolimus Eye Drops
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ocular Penetration of Topical Tacrolimus
Keywords: Tacrolimus
Ocular penetration
Topical
Lead sponsor: The Eye Center and The Eye Foundation for Research in Ophthalmology
Sponsor class: OTHER
First posted: 2016-06-09
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Investigators aim to evaluate the ocular penetration of topical tacrolimus 0.03% eye drops.

Topical tacrolimus 0.03% will be instilled into the eyes of patients 15 minutes before cataract surgery. Aqueous samples will be collected at the time of cataract surgery and will be subjected to detection of presence and level of tacrolimus.


Eligibility criteria: Inclusion Criteria:

* Any age or gender
* Patients scheduled for routine cataract surgery
* Clear healthy cornea

Exclusion Criteria:

* Corneal pathology
* Ocular surface disease
* Intraocular inflammation

Primary outcomes:
measure: Detection of the concentration of tacrolimus ( nanograms/milliliter) in the anterior chamber following ocular topical application.
timeFrame: From date of obtaining the aqueous samples until getting the laboratory results of concentration of topical tacrolimus in the aqueous humor up to 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: The Eye Center
Study officials:
References:
citation: Shoughy SS, Aljassar FM, Tabbara KF. Aqueous penetration of topical tacrolimus. Am J Ophthalmol Case Rep. 2020 Jan 17;17:100582. doi: 10.1016/j.ajoc.2019.100582. eCollection 2020 Mar.
Clinical trial NCT04729010: Acupuncture for Anxiety in Parkinson's Disease
Official title: Acupuncture as a Symptomatic Treatment for Anxiety in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Anxiety
Keywords: Acupuncture, Anxiety, Parkinson's Disease
Lead sponsor: Xiamen University
Sponsor class: OTHER
First posted: 2021-01-28
Enrollment: 30
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a single-center, double-blind, placebo-controlled trial to see if acupuncture can safely and effectively manage anxiety in Parkinson's Disease. Eligible subjects will receive either real or sham acupuncture THREE times weekly for a total of SIX weeks.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with Parkinson's Disease by authorized Neurologist.
* Patients 40-75 years of age
* Patients who have significant anxiety symptom
* Patients must be on a stable medication regimen for the treatment of PD

Exclusion Criteria:

* Patients who have had previous acupuncture within the past SIX months
* Patients with dementia, depression, or sleep disorder
* Patients who are currently taking medications known to affect anxiety

Primary outcomes:
measure: Change in the Hamilton Anxiety Scale (HAM-A) between the treatment group.
timeFrame: SIX weeks
measure: Change in the Generalized Anxiety Disorder 7-Item (GAD-7) scale between the treatment group.
timeFrame: SIX Weeks
Secondary outcomes:
measure: Change in the Unified Parkinson's Disease Rating Scale between the treatment group.
timeFrame: THREE months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00281710: Urinary Aquaporin 2 Excretion After Methylprednisolone in Fasting Healthy Humans
Official title: Urinary Aquaporin 2 Excretion After Methylprednisolone in Fasting Healthy Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy
Keywords: AQP-2
Methylprednisolone
Urinary concentrating ability
Lead sponsor: Regional Hospital Holstebro
Sponsor class: OTHER
First posted: 2006-01-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: We wanted to test the hypotheses that methylprednisolone up regulates u-AQP-2 in fasting healthy humans


Eligibility criteria: Inclusion Criteria:

* (1) Genders; both mal and female
* (2) Age; 18- 65 years old
* (3) BMI; below 30
* (4) Females had to bee in oral contraceptive treatment

Exclusion Criteria:

* (1) Clinical signs or history of disease in the heart, lungs, kidneys or endocrine organs
* (2) Abnormal laboratory test (blood haemoglobin, white cell count, platelets, plasma sodium, plasma potassium, plasma creatinine, plasma albumin, plasma bilirubin, plasma alanine aminotransferase, plasma cholesterol and blood glucose)
* (3) Albuminuria or glucosuria
* (4) Cancer
* (5) Arterial hypertension
* (6) Alcohol abuse
* (7) Use of tobacco
* (8) Medical treatment, except oral contraceptives
* (9) Pregnancy or breast feeding
* (10) Medicine abuse
* (11) Donation of blood less than 1 month before the study.

Primary outcomes:
measure: u-AQP-2
measure: FeNa+
Secondary outcomes:
Other outcomes:
Locations:
city: Holstebro
country: Denmark
facility: Department of Medicine, Holstebro Hospital
Study officials:
affiliation: Holstebro Hospital, 7500 Holstebro, Denmark
name: Erling B Pedersen, Professor
role: STUDY_CHAIR
affiliation: Holstebro Sygehus
name: Thomas G Knudsen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00619710: Complicated Skin and Skin Structure Infections
Official title: A Multicenter, Randomized, Double Blind, Comparative Trial of Intravenous MERREM (Meropenem, ICI 194,660) vs PRIMAXIN I.V. (Imipenem-cilastatin) in the Treatment of Hospitalised Subjects With Complicated Skin and Skin Structure Infections.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Skin Infection
Abscess
Cellulitis
Keywords: skin infections
MERREM
PRIMAXIN IV
complex abscess
perirectal abscess
wound infections
infected ischemic/diabetic ulcers
cellulitis
Meropenem
Imipenem-cilastatin
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-02-21
Enrollment: 1000
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to demonstrate the non-inferiority of meropenem (Merrem) and imipenem in hospitalised subjects with complicated skin and skin structure infections.


Eligibility criteria: Inclusion Criteria:

* Subjects are hospitalized males and females, aged 13 years or older, with clinical evidence of complicated skin and skin structure bacterial infection with material suitable for culture from 1 primary site of infections
* Within 72 hours before enrollment or at the time of enrollment, all subjects must provide an appropriate specimen for culture and susceptibility testing
* Subjects who have been given prior antibacterial therapy within 14 days of trial entry may be entered only if a culture is obtained showing persistence of a pathogen in blood or at the site of infection

Exclusion Criteria:

* Subjects with a known or suspected hypersensitivity to cephalosporins, penicillins, or carbapenems
* Subjects with a history of seizure disorders or subjects currently receiving antiepileptic medication
* Subjects with underlying infections or conditions which would interfere with evaluation of this study

Primary outcomes:
measure: The primary measure is clinical response after all antibacterial treatment is stopped).
timeFrame: 7-28 days
Secondary outcomes:
measure: clinical and microbiological response
timeFrame: Twice 3-28 days
Other outcomes:
Locations:
Study officials:
References: