louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04728009: Safety and Efficacy of Longan and Lingzhi Mushroom Syrup on Immune and Inflammatory Responses in Healthy Volunteers
Official title: Safety and Efficacy of Longan and Lingzhi Mushroom Syrup on Immune and Inflammatory Responses in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Safety Issues
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2021-01-28
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study aimed to preliminarily determine safety and efficacy of longan and lingzhi mushroom syrup on immune and inflammatory responses. Apparently healthy Thai adults (N = 8) aged 18-60 years were recruited into a prospective, single-group study. All participants were assigned to consume 5 mL of longan and lingzhi mushroom syrup daily for 12 weeks. Blood concentrations of fasting plasma glucose (FPG), glycated hemoglobin (HbA1c), aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), BUN (blood urea nitrogen), creatinine (Cr), immunoglobulins (IgG, IgM, IgA, and IgE), and C-reactive protein (CRP) were measured at baseline (week 0), week 4, week 8, and week 12.


Eligibility criteria: Inclusion Criteria:

1. Apparently healthy adults at Mae Fah Luang University and Chulalongkorn University
2. aged 18-60 years
3. HbA1c \< 7%

Exclusion Criteria:

1. self-reported immunodeficiency diseases, autoimmune diseases, infectious diseases, diabetes, thyroid diseases, cancer, hepatic- and/or renal dysfunction, uncontrollable illnesses and life-threatening diseases
2. being allergic to longan and lingzhi products
3. taking medications, herbs, and diet supplements affecting immune system, inflammatory response, and blood glucose a month before study enrollment
4. pregnant and breastfeeding women

Primary outcomes:
measure: Adverse effects on fasting blood glucose
timeFrame: 12 weeks
measure: Adverse effects on long-term glycemic control
timeFrame: 12 weeks
measure: Adverse effects on hepatic function (1)
timeFrame: 12 weeks
measure: Adverse effects on hepatic function (2)
timeFrame: 12 weeks
measure: Adverse effects on hepatic function (3)
timeFrame: 12 weeks
measure: Adverse effects on renal function (1)
timeFrame: 12 weeks
measure: Adverse effects on renal function (2)
timeFrame: 12 weeks
Secondary outcomes:
measure: Effect on immune responses (1)
timeFrame: 12 weeks
measure: Effect on immune responses (2)
timeFrame: 12 weeks
measure: Effect on immune responses (3)
timeFrame: 12 weeks
measure: Effect on immune responses (4)
timeFrame: 12 weeks
measure: Effect on inflammatory responses
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Chulalongkorn Unviersity
Study officials:
References:
Clinical trial NCT05456009: Exhaled Breath Analysis in Human Subjects
Official title: Exhaled Breath Analysis by Secondary Electrospray Ionization - Mass Spectrometry (SESI-MS) in Human Subjects
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Exhaled Breath Pattern After Medication Intake, in OSA Patients, or Other Pulmonary Diseases
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Deep Breath Intelligence (DBI)
First posted: 2022-07-13
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Population of human subjects with heart failure, dementia syndrome, parkinson disease, obstructive sleep apnea, chronic obstructive pulmonary disease, pneumonia, specific medication use.

Brief summary: Identification of exhaled breath pattern of human subjects

Detailed description: Breath analysis with mass spectormetry as a non-invasive method to identfy exhaled breath patterns.

Eligibility criteria: Inclusion Criteria:

* \>= 18 years
* Informed consent

Exclusion Criteria:

* specific exclusion criteria for different subgroups

Primary outcomes:
measure: Exhaled breath pattern
timeFrame: baseline
Secondary outcomes:
measure: Chemical structure of exhaled breath molecules
timeFrame: baseline
measure: Body fluids
timeFrame: baseline
measure: Disease marker
timeFrame: baseline
measure: Distinguish between disease
timeFrame: baseline
measure: Health state
timeFrame: baseline
measure: Medication
timeFrame: baseline
measure: Excretion of drugs
timeFrame: baseline
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: University Hospital Zurich
state: Zurich
Study officials:
References:
Clinical trial NCT06263309: Mid-Term Radiological Outcomes of Femoral Neck Fractures Treated With Osteosynthesis: A Comparative Analysis
Official title: Mid-Term Radiological Outcomes of Femoral Neck Fractures Treated With Osteosynthesis: A Comparative Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Femoral Neck Fractures
Femoral Neck Shortening
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2024-02-16
Enrollment: 10
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who underwent osteosynthesis for femoral neck fracture (FNF)

Brief summary: OBJECTIVES: This study assesses the efficacy of dynamic hip screw (DHS) versus cannulated screws for femoral neck fractures, focusing on femoral neck shortening, avascular necrosis (AVN) incidence, and functional outcomes.

METHODS:

Design: Retrospective cohort study. Setting: Academic Level I Trauma Center. Patient Selection Criteria: Included were patients with femoral neck fractures treated with DHS or cannulated screws, with follow-up data available.

Outcome Measures and Comparisons: Main outcomes were femoral neck shortening, incidence of AVN, and Harris Hip Score (HHS) for functional assessment.


Eligibility criteria: Inclusion Criteria:

* Patients aged 80 years and younger
* Minimum of 2 years' follow-up
* Diagnosed with a femoral neck fracture
* Treated with either cannulated screws or a Dynamic Hip Screw (DHS).

Exclusion Criteria:

* Patients with multiple fractures in the same extremity
* Presence of malignancy
* Diagnosis of osteoporosis
* Systemic inflammatory or metabolic diseases
* Infection or malignancy in the hip joint
* Insufficient medical records
* Patients unwilling to participate in the study.

Primary outcomes:
measure: Harris Hip score
timeFrame: minimum 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: University
Study officials:
References:
Clinical trial NCT00934609: Training Study to Evaluate the Benefit of Exercise for Patients With Chronic Heart Failure
Official title: Effects of 12-weeks Endurance Training in Patients With Chronic Heart Failure Due to Dilated Cardiomyopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dilated Cardiomyopathy
Chronic Heart Failure
Keywords: Exercise
heart failure
dilated cardiomyopathy
Endurance training
Lead sponsor: Universität des Saarlandes
Sponsor class: OTHER
Collaborators: name: The German Heart Foundation
First posted: 2009-07-08
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study investigates the safety and effectiveness of a 12 week endurance training program for patients with chronic heart failure


Eligibility criteria: Inclusion Criteria:

* chronic heart failure NYHA stage 2 and 3

Exclusion Criteria:

* Valvular disease
* recent decompensation
* Other complaints that might interfere with ergometer exercise

Primary outcomes:
measure: Physical capacity
Secondary outcomes:
measure: Left ventricular function
measure: occurence of complications
timeFrame: within study period
Other outcomes:
Locations:
city: Saarbrücken
country: Germany
facility: Institute of Sports- and Preventive Medicine, Saarland University
state: Saarland
Study officials:
References:
Clinical trial NCT04724109: A Study of Equfina® on the Incidences of Adverse Drug Reactions in Participants With Parkinson's Disease (Including Participants With Hepatic Impairment)
Official title: Protocol for Study EQF01S: General Drug Use-Results Observational Study of Equfina® TABLETS 50 mg Observational Study on the Incidences of Adverse Drug Reactions in Patients With Parkinson's Disease (Including Patients With Hepatic Impairment)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Keywords: Parkinson Disease
Parkinsonian Disorders
Prospective
Non-interventional
Hepatic Impairment
Equfina
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2021-01-26
Enrollment: 1088
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Approximately 1000 participants with parkinson's disease (including approximately 30 participants with hepatic impairment)

Brief summary: The purpose of the study is to investigate the incidences of psychiatric symptoms (example, hallucinations), somnolence and sudden onset of sleep, dyskinesia, and retinal degeneration-related events during treatment with Equfina in participants with parkinson's disease (including participants with hepatic impairment).


Eligibility criteria: Inclusion Criteria:

1. Participants with Parkinson's disease, who are naïve to Equfina

Exclusion Criteria:

1. Participants previously treated with Equfina
2. Participants who have contraindications on package insert of Equfina

Primary outcomes:
measure: Number of Participants with Adverse Events (AEs) and Adverse Drug Reactions (ADRs)
timeFrame: Up to 24 Weeks
measure: Incidence Rate of ADRs Based on Baseline Characteristics of the Participants
timeFrame: Up to 24 Weeks
measure: Change From Baseline in Symptoms of Parkinson's Disease After the Start of Treatment with Equfina
timeFrame: Baseline, up to Week 24
Secondary outcomes:
Other outcomes:
Locations:
city: Osaka
country: Japan
facility: Eisai Trial Site 2
city: Tokyo
country: Japan
facility: Eisai Trial Site 1
Study officials:
References:
Clinical trial NCT02585609: Sleep Quality in Patients With Advanced Cancer
Official title: Sleep Quality in Patients With Advanced Cancer. A Comparison of Objective Assessments and Self-reports of Sleep Quality
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Disorders
Neoplasms
Keywords: Sleep
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
First posted: 2015-10-23
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with advanced cancer using opioids (step III on the WHO pain ladder)

Brief summary: The primary focus of this clinical study is the objective and subjective measurements of sleep quality in patients with advanced cancer using opioids. It also examines sleep disturbances and associations between sleep quality and symptoms in order to improve symptom management in patients with advanced cancer.

The overall aim of this study is to improve the clinical understanding of sleep quality in patients with advanced cancer using opioids and to improve the understanding of how sleep quality may best be measured in order to improve symptom management.


Eligibility criteria: Inclusion Criteria:

* A verified diagnosis of a malignant disease
* Presence of metastatic/disseminated disease
* Regularly scheduled oral, subcutaneous, transdermal or intravenous opioid treatment corresponding to step III at the WHO pain ladder with a duration of treatment not less than 3 days
* Able to comply with all study procedures
* Signed informed consent according to ICH Good Clinical Practice and national/local regulations

Exclusion Criteria:

* Not consenting to participation
* Not mastering the language used at the study centre
* Severe cognitive impairment as judged by the principal investigator
* Any reason why, in the opinion of the investigator, the patient should not participate
* Impaired use of the dominant arm
* Local anatomical illness or abnormalities precluding the use of polysomnography (e.g. facial tumour)
* having received chemotherapy for more than 4 weeks, having received the previous dose less than 5 days ago and receiving the next dose within the study period.

Primary outcomes:
measure: total sleep time
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Institutt for sirkulasjon og bildediagnostikk
Study officials:
affiliation: Norwegian University of Science and Technology
name: Pål Klepstad, md phd
role: STUDY_DIRECTOR
References:
Clinical trial NCT01210209: Study of Blood Samples From Patients With Ewing Sarcoma and Their Relatives
Official title: GENEWING - A Genome Wide Association Study in Ewing Sarcoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sarcoma
Keywords: Ewing sarcoma
Ewing sarcoma/peripheral primitive neuroectodermal tumor (PNET)
Lead sponsor: Institut Curie
Sponsor class: OTHER
First posted: 2010-09-28
Enrollment: 350
Sex: ALL
Minimum age (years): 0
Maximum age (years): 120
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: FAMILY_BASED
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Ewing's sarcoma, with idenfication of a specific translocation of Ewing's sarcoma

Brief summary: RATIONALE: Studying samples of blood in the laboratory from patients with cancer and their relatives may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is looking at blood samples collected from patients with Ewing sarcoma and their relatives.

Detailed description: OBJECTIVES:

* To identify and characterize a genetic susceptibility factor to Ewing's sarcoma by performing a Genome-Wide Association Study with as many as possible Ewing sarcoma patients.

OUTLINE: This is a multicenter study.

Blood samples are collected from patients and their relatives. Blood DNA samples are analyzed for susceptibility genes of Ewing Sarcoma.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Patients with Ewing sarcoma
* Relatives of Ewing sarcoma patients

PATIENT CHARACTERISTICS:

* Patients with a fusion genes specific of Ewing Sarcoma

PRIOR CONCURRENT THERAPY:

* Not applicable

Primary outcomes:
measure: Identification and characterization of susceptibility genes in patients with Ewing sarcoma
timeFrame: Through study completion, an average of 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Institut Curie Hopital
Study officials:
affiliation: Institut Curie
name: Olivier Delattre, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04838509: Diagnoses Associated With Persistent Elevation of Creatine Kinase
Official title: Diagnoses Associated With Persistent Elevation of Creatine Kinase
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Creatine Kinase
Muscular Diseases
Keywords: Creatine Kinase
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2021-04-09
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients hospitalised in the ward of internal medicin of Nancy University Hospital or UNEOS General Hospital of Metz between 2009 and 2018.

Brief summary: Serum creatinine kinase (CK) level varies with age, gender, race and physical activity. For these reasons there is no normal serum CK level. Many pathological situations cause hyperCKemia, such as neuromuscular disorders (muscular dystrophy, inflammatory myositis, mitochondrial myopathy) and multiple systemic causes. The diagnostic approach to pauci or asymtomatic hyperCKemia can therefore be difficult and lead to multiple, and sometimes invasive tests, such as muscle biopsy. This study aims to describe the diagnoses associated with persistent elevation of serum creatine kinase and to precise the role of the muscule biopsy.


Eligibility criteria: Inclusion Criteria:

* patients hospitalised in a ward of internal medicin
* having a persistent elevation of serum creatine kinase \>3 times the upper normal laboratory value, repeated for 2 times

Exclusion Criteria:

* known neuro-muscular disease causing elevation of creatine kinase
* evident post-traumatic cause responsible for the elevation of creatine kinase
* incomplete medical records

Primary outcomes:
measure: Diagnosis
timeFrame: at the end of all investigations, an average of 12 months
Secondary outcomes:
measure: Muscle biopsy
timeFrame: at the end of all investigations, an average of 12 months
measure: Clinical presentation
timeFrame: at the end of all investigations, an average of 12 months
measure: Paraclinical presentation
timeFrame: at the end of all investigations, an average of 12 months
Other outcomes:
Locations:
city: Nancy
country: France
facility: CHRU Nancy
Study officials:
References:
Clinical trial NCT02017509: Immunoscore in Rectal Cancer
Official title: A Study to Determine the Immunopheotype of Locally Advanced Rectal Adenocarcinoma and Its Correlation With the Efficacy of Neoadjuvant Chemoradiotherapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer of the Rectum
Neoplasms, Rectal
Rectal Cancer
Rectal Tumors
Rectal Adenocarcinoma
Keywords: Immunophenotype
Immunoscore
MRI
RNA Later
Lead sponsor: Providence Health & Services
Sponsor class: OTHER
Collaborators: name: Oregon Health and Science University
First posted: 2013-12-20
Enrollment: 3
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: Patients with a diagnosis of a rectal mass suspicious for or known to be an adenocarcinoma of the rectum.

Brief summary: This is an observational study of tumor samples and MRI imaging in patients with colorectal cancers. A tumor sample, MRI scans, and treatment outcome data will be used for research purposes to see if it is possible to predict patients' response to treatment.

Detailed description: The quality of the immune environment in colorectal cancer biopsy samples correlates with disease-free survival and overall survival more so than current staging conventions. This study will use a scoring system called 'immunoscore' to characterize the immune enviroment. Researchers hypothesize that the immunoscore will correlate with outcomes of colorectal patients treated with neoadjuvant chemoradiation.

Eligibility criteria: Inclusion Criteria:

* Patients with a diagnosis of a rectal mass suspicious for or known to be an adenocarcinoma of the rectum.
* Age \> 18
* Ability to give informed consent and comply with the protocol. Patients with a history of psychiatric illness must be judged able to understand fully the investigational nature of the study and the risks associated with the therapy.

Exclusion Criteria:

* History of other malignancy in the past 2 years except carcinoma in situ of the cervix or bladder, or non-melanomatous skin cancer
* Other medical or psychiatric conditions that in the opinion of the Principal Investigator would preclude safe participation in protocol.

Primary outcomes:
measure: Correlation of the number of infiltrating leukocytes within a biopsy sample with pathologic response
timeFrame: 16 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Providence Health & Services
state: Oregon
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Earle A. Chiles Research Institute at Providence Health & Services
name: Marka Crittenden, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01224509: The Effect of Mifepristone on the Expression of Cervical Prostaglandin EP3 Receptors
Official title: Cervical Prostaglandin EP3 Receptor mRNA Expression 48 Hours After Administration of Mifepristone
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cervical Prostaglandin EP3 Receptors
Pregnancy
Keywords: Cervix
EP3 receptors
Mifepristone
Prostaglandin
Receptors
Steroids
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2010-10-20
Enrollment: 18
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine the effect of mifepristone on the expression of three cervical EP3 receptor isoforms (EP3-2, EP3-3 and EP3-6) in pregnant women ≤63 days gestational age.


Eligibility criteria: Inclusion Criteria:

* good general health
* ≥18 years old
* seeking termination of a viable intrauterine pregnancy of ≤63 days, without any evidence of a threatened or spontaneous abortion

Exclusion Criteria:

* medical problems
* confirmed or suspected ectopic pregnancy
* having taken medications in the seven days prior to enrollment that would affect PG synthesis or metabolism of mifepristone

Primary outcomes:
measure: The amount of expression of EP3 receptor mRNA levels in cervical tissue after the administration of mifepristone
timeFrame: 48 hours after the administration of mifepristone
Secondary outcomes:
measure: The degree of cervical dilation after the administration of mifepristone
timeFrame: 48 hours after the administration of mifepristone
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Women's and Children's Hospital, Reproductive Research Center
state: California
Study officials:
affiliation: University of Southern California
name: Marie-Soleil Wagner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Southern California
name: John K Jain, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00761709: Safety and Intraocular Pressure (IOP)-Lowering Efficacy of AL-39256 in Patients With Open-Angle Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Open-Angle Glaucoma
Ocular Hypertension
Keywords: Open Angle Glaucoma
Ocular Hypertension
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2008-09-29
Enrollment: 104
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: The purpose of this study is to evaluate the safety and intraocular pressure (IOP)-lowering efficacy of AL-39256 in patients with open-angle glaucoma or ocular hypertension.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with open-angle glaucoma or ocular hypertension.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Females of childbearing potential.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Mean change from baseline in IOP
timeFrame: Week 4
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Theresa Landry, Ph.D.
role: STUDY_DIRECTOR
References: