louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03277833: Efficacy and Safety of Gynostemma Pentaphyllum(Dungkulcha) Extract on Alleviation of Chronic Stress-induced Strain
Official title: Efficacy and Safety of Gynostemma Pentaphyllum(Dungkulcha) Extract on Alleviation of Chronic Stress-induced Strain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Stress-Induced Strain
Lead sponsor: Chonbuk National University Hospital
Sponsor class: OTHER
First posted: 2017-09-11
Enrollment: 72
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators performed a 8-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Gynostemma Pentaphyllum(Dungkulcha) on alleviation of chronic stress-induced strain. The investigators measured decrement of body fat parameters, State\&Trait version of STAI, Beck Anxiety Inventory(BAI), Hamilton Anxiety Inventory(HAM-A), and monitored their blood pressure.


Eligibility criteria: Inclusion Criteria:

• Age 20-65 years with chronic stress( S-STAI score 40\~60)

Exclusion Criteria:

* excessive physically chronic fatigue
* Subjects taking antidepressants, anxiolytics, hypnotics within the last 2 months prior to the study
* Cardiovascular disease
* Allergic or hypersensitive to any of the ingredients in the test products
* History of reaction to any of the test products or of gastrointestinal diseases such as Crohn's disease or gastrointestinal surgery
* Participation in any other clinical trials within past 2 months
* Renal disease
* Abnormal hepatic function
* Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study
* History of alcohol or substance abuse
* Pregnancy or lacting women etc.

Primary outcomes:
measure: Change in score of State&Trait version of STAI
timeFrame: Baseline and 8 weeks
Secondary outcomes:
measure: Change of Blood Norepinephrine Level
timeFrame: Baseline and 8 week
measure: Change of Blood Cortisol Level
timeFrame: Baseline and 8 week
measure: Change in score of Beck Anxiety Inventory
timeFrame: Baseline and 8 week
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01814033: Use of the LRU Pillow in the Acute Setting Following Total Knee Arthroplasty
Official title: Use of the LRU Pillow in the Acute Setting Following Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Osteoarthritis
Keywords: LRU
Total Knee Arthroplasty
Total Knee Replacement
Acute Rehabilitation Total Knee
Total Knee Range of Motion
Total Knee Acute care Outcomes
Lead sponsor: Newton-Wellesley Hospital
Sponsor class: OTHER
First posted: 2013-03-19
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The Null Hypothesis is that there is no significant change in range of motion (ROM), pain, or function for a group of patients following total knee arthroplasty (TKA) who use the LRU pillow as compared to a control group of total knee arthroplasty patients who do not use the pillow.

Detailed description: 1. Study design will be a Pretest-Posttest Control Group Design . Enrollment would be random assignment of 20 patients to a control group vs 20 patients to a treatment group for patients with the diagnosis of osteoarthritis (OA) of the knee admitted for primary total knee arthroplasty. For specifics of patient assignment, please see below under Recruitment Procedures.
2. Unpaired t-Tests will be used to determine differences between mean scores for the dependent variables (pain, range of motion, functional mobility). Analysis of Covariance will be run to quantify the effect of the co-variates of age, gender, body mass index (BMI), and contralateral previous TKA. Confidence Intervals will be set at 95%.

Eligibility criteria: Inclusion Criteria:

* Primary total knee arthroplasty patients with primary diagnosis of osteoarthritis.

Exclusion criteria:

* bilateral total knee arthroplasties
* revision total knee arthroplasties
* unexpected decline in medical or mental status
* Subjects will range from 30 years of age to 80 years of age
* primary diagnosis of rheumatoid arthritis

Primary outcomes:
measure: Range of Motion
timeFrame: 3 Days
Secondary outcomes:
measure: Pain
timeFrame: 3 Days
Other outcomes:
measure: Function
timeFrame: 3 Days
Locations:
city: Newton
country: United States
facility: Newton Wellesley Hospital
state: Massachusetts
Study officials:
affiliation: Newton-Wellesley Hospital
name: Theresa J Gustus, PT, DPT, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Khanasuk Y, Ngarmukos S. Contemporary pain management in total knee arthroplasty. J Med Assoc Thai. 2012 Oct;95 Suppl 10:S238-44.
Clinical trial NCT01936233: Clinical Study of Antiviral and Aspirin Treatment in Liver Cancer After Radical Surgery
Official title: Liver Cancer Institiute ,Fudan University
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hepatocellular Carcinoma
Recurrence
Keywords: Hepatocellular Carcinoma
Aspirin
antiviral treatment
recurrence free survival
radical therapy
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2013-09-06
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Evaluation the Treatment Outcome of Antiviral and Aspirin Treatment in Liver Cancer After Radical Surgery.

Detailed description: The investigators conduct this clinical trial to evaluate the treatment outcome of Antiviral and Aspirin Treatment in Liver Cancer After Radical Surgery.The primary outcome is overall survival and objective response rate.

Eligibility criteria: Inclusion Criteria:

* Hepatocellular carcinoma confirmed with pathology or identified with radiological images with typical features
* Age ≥ 18 years and ≤ 75 years
* At least one tumor nodule with one uni-dimension of ≥ 2 cm
* Child-Pugh Class A or B
* HBV-DNA\>10\^4
* Total bilirubin ≤ 1.5 x upper limit of normal
* ALT and AST ≤ 2.0 x the upper limit of normal
* PT-INR\<2.3,PTT \< 1.5 x upper limit of normal
* Serum creatinine ≤ 1.5x upper limit of normal
* Peripheral white blood cell count of or more than 3×10(9)/L
* Peripheral platelet of or more than 50×10(9)/L
* Expected survival time not less than 3 months
* ECOG score 0-2

Exclusion Criteria:

* Tumor thrombi in main branch of portal vein
* Tumor involvement more than 70% of whole liver
* With extrahepatic metastasis
* Prior systemic chemotherapy or chemoembolization
* Congestive heart failure \> NYHA class 2
* History of HIV infection
* Active clinically serious infections (\> 2 NCI-CTC Version 3.0)
* Recurrence of HCC after liver transplantation
* Pregnant or breast-feeding
* Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in this study
* Known or suspected allergy to any agent given in association with this trial
* Patients unable to swallow oral medication
* Inclined to thrombosis
* Inclined to hemorrhage or active hemorrhage with 1 month

Primary outcomes:
measure: recurrence free survival
timeFrame: 36 months
Secondary outcomes:
measure: overall survival
timeFrame: 36 months
measure: adverse events
timeFrame: 36 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Liver Cancer Institute
state: Shanghai
Study officials:
affiliation: Fudan University
name: Zhenggang Ren, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00610233: Effect of Deep Brain Stimulation on Lower Urinary Tract Function
Official title: Effect of Deep Brain Stimulation (DBS) on Lower Urinary Tract (LUT) Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Movement Disorder
Urinary Tract Disease
Keywords: deep brain stimulation
urodynamics
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
First posted: 2008-02-07
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: The precise mechanisms underlying cerebral regulation of lower urinary tract (LUT) function are still poorly understood. Patients with deep brain stimulation (DBS) offer the unique opportunity to investigate the role of different cerebral centers on LUT function.

We hypothesize that DBS has a significant effect on LUT function and that these effects depend on the specific stimulated cerebral center.


Eligibility criteria: Inclusion Criteria:

* Patients with deep brain stimulation (DBS)

Exclusion Criteria:

* Pregnancy
* Age \<18 years

Primary outcomes:
measure: Effect of deep brain stimulation (DBS) on urodynamic parameters
timeFrame: immediately and 3 months after study inclusion
Secondary outcomes:
measure: Changes in questionnaire data due to deep brain stimulation (DBS)
timeFrame: 3 months
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: Department of Neurology, University of Bern
city: Bern
country: Switzerland
facility: Department of Urology, University of Bern
Study officials:
affiliation: Department of Urology, University of Bern, 3010 Switzerland
name: Thomas M Kessler, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04533633: German Epicardial Collateral CTO Registry
Official title: German Multicentre Registry to Evaluate the Technical Feasibilty of Epicardial Collateral Connections in CTO PCI
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Chronic Total Occlusion
Percutaneous Coronary Intervention
Lead sponsor: Universitätsmedizin Mannheim
Sponsor class: OTHER
Collaborators: name: University Heart Center Freiburg - Bad Krozingen
First posted: 2020-08-31
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: EPIC will observationally evaluate all patients undergoing retrograde CTO-PCI using epicardial collateral connections during daily clinical practice from German CTO centres.

Brief summary: The EPIC registry is an observational multicentre registry evaluating the technical feasibility of retrograde CTO-PCI using epicardial collateral connections. It will evaluate the frequency, effectiveness, safety and outcomes of patients who underwent CTO-PCI using this approach. The EPIC registry retrieves data from CTO centres across Germany.

Detailed description: The EPIC registry is the first German-wide observational multicentre registry evaluating the technical feasibility, clinical success and safety of retrograde CTO-PCI using epicardial collateral connections. The EPIC registry retrieves data from CTO centres across Germany. All patients will be followed-up to 30 days after inclusion.

Eligibility criteria: Inclusion Criteria:

* All patients undergoing retrograde CTO-PCI using epicardial collateral connections during daily clinical practice.

Exclusion Criteria:

* None.

Primary outcomes:
measure: Rate of technically successful retrograde CTO-PCI using epicaridal collaterals
timeFrame: 30 days
Secondary outcomes:
measure: Rate of clinically successful retrograde CTO-PCI using epicaridal collaterals
timeFrame: 30 days
measure: Rate of failed retrograde CTO-PCI using epicaridal collaterals
timeFrame: 30 days
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: University Medical Centre Mannheim
state: Baden Württemberg
Study officials:
References:
Clinical trial NCT04560933: A Study to Evaluate Seroprevalence and Seroconversion of Antibodies to Adeno-Associated Virus (AAV) in Patients With Hemophilia A
Official title: A Prospective, Observational Study Evaluating Seroprevalence and Rate of Seroconversion of Antibodies Against Adeno-associated Virus (AAV) Serotypes and Exploratory Vectors in Subjects With Hemophilia A in the United States
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemophilia A
Lead sponsor: BioMarin Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2020-09-23
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects diagnosed with Hemophilia A

Brief summary: To quantify the seroprevalence of antibodies to AAV5, AAV6, and AAV8 and the seroconversion rate over varying follow-up intervals in subjects with hemophilia A

Detailed description: This is a single-center, decentralized, patient-centered, prospective, observational study utilizing biospecimen samples collected from hemophilia A subjects across the United States to evaluate and characterize seroprevalence and the rate of seroconversion of antibodies against AAV serotypes and exploratory vectors, and to investigate the associated factors that may influence the vector titers.

Relevant medical findings will also be collected from the subject, as well as symptoms related to hemophilia A. The collection of medical history may include major illnesses, diagnoses, and surgeries.

Eligibility criteria: Inclusion Criteria:

* Subjects diagnosed with Hemophilia A
* Subjects aged 18years or over at time of entry

Exclusion Criteria:

* Currently participating in an interventional study of any investigational product, device or procedure.
* Subjects who have been previously treated with AAV vector gene therapy

Primary outcomes:
measure: Assess the Seroprevalence of antibodies to AAV vectors in patients with hemophilia A
timeFrame: Baseline
measure: Assess the rate of Seroconversion of antibodies to AAV vectors in patients with hemophilia A
timeFrame: Change from baseline through Week 12
Secondary outcomes:
measure: To describe and characterize AAV vector titer values in subjects with Hemophilia A
timeFrame: Change from baseline through Week 12
measure: To describe and characterize AAV vector titer values in subjects with Hemophilia A
timeFrame: Change from baseline through Week 24
Other outcomes:
Locations:
city: Madison
country: United States
facility: Covance Inc
state: Wisconsin
Study officials:
affiliation: Covance
name: Stephen Flach, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04788433: Registry of Coronavirus Complications - CORRELATION WITH GLYCOMIC PROFILE in COVID-19 Patients
Official title: ROCCO - Registry of Coronavirus Complications. Prospective Observational Study on Coronavirus Complications and Correlation With Glycomic Profile in COVID-19 Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Pain
Morbidity, Multiple
Covid19
Lead sponsor: Papa Giovanni XXIII Hospital
Sponsor class: OTHER
Collaborators: name: GENOS
First posted: 2021-03-09
Enrollment: 374
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with documented infection by Sars-CoV2 with different degrees of clinical severity.

Brief summary: COVID infection has resulted in multi-organ injury and may result in cardiovascular, pulmonary, neurological, and muscular damage. It is associated with significant asthenia and the long-term effects of the infection are still unclear, particularly for the development of pain and delayed functional rehabilitation.

Glycomics "is the systematic study of the structure of glycans in a given cell type or organism. Glycans are complex oligosaccharides attached to proteins and lipids that regulate a variety of organic processes, including immunity Thus, glycans may influence different moments of the response to the virus and involved in the clinical severity of the disease, but may also change depending on the severity of symptoms and the organic response to SARS-CoV-2 infection.

Glycomic data could provide important insights into interindividual differences at the molecular level that directly interact with SARS-CoV-2 and the development of mid- and long-term side effects. The ability to identify early those susceptible to developing COVID-19 infection and at higher risk for COVID-19 with unfavorable outcomes long after infection would help guide therapeutic strategy and provide important guidance for rational health care organization, which is of outmost importance.

Long-term outcome data regarding post-COVID patient functional capacity and glycomics will be compared to assess whether there may be differences in protein glycosylation that may predict patient outcome.


Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of COVID19 virus infection (buffer/BAL/positive IgG serology)
* Age \>18 years
* Able to express informed consent to participate in the study

Exclusion Criteria:

* patients unable to express consent,
* patients aged \<18 yr,
* with signs and symptoms compatible with Covid-19 but without certified diagnosis by swab/BAL or serological examination of presence of COVID IgG antibodies

Primary outcomes:
measure: Glycomic profile as predictor of long-term morbidity
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Bergamo
country: Italy
facility: Aast Papa Giovanni Xxiii
Study officials:
References:
Clinical trial NCT01598233: Effects of Intragastric Balloon on Bone, Metabolic and Respiratory Parameters
Official title: Effects of Intragastric Balloon on Bone, Metabolic and Respiratory Parameters
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Overweight
Obesity
Metabolic Syndrome
Lead sponsor: Universidade Federal do Rio de Janeiro
Sponsor class: OTHER
First posted: 2012-05-15
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effects of intragastric balloon on bone, metabolic and respiratory parameters in 50 patients with metabolic syndrome.


Eligibility criteria: Inclusion Criteria:

* metabolic syndrome (IDF criteria)

Exclusion Criteria:

* menopause
* older than 50 years
* diabetes mellitus

Primary outcomes:
measure: Change in bone mineral density and body composition
timeFrame: Baseline and 6 months
measure: Change in fasting and postprandial glucose
timeFrame: Baseline and 6 months
measure: Change in Pulmonary function tests
timeFrame: Baseline and 6 months
measure: Change in bone microarchitecture
timeFrame: Baseline and 6 months
measure: Change in lipid profile
timeFrame: Baseline and 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Universidade Estadual do Rio de Janeiro
Study officials:
References:
citation: Guedes EP, Madeira E, Mafort TT, Madeira M, Moreira RO, de Mendonca LMC, de Godoy-Matos AF, Lopes AJ, Farias MLF. Impact of 6 months of treatment with intragastric balloon on body fat and quality of life in obese individuals with metabolic syndrome. Health Qual Life Outcomes. 2017 Oct 24;15(1):211. doi: 10.1186/s12955-017-0790-x.
citation: Guedes EP, Madeira E, Mafort TT, Madeira M, Moreira RO, Mendonca LM, Godoy-Matos AF, Lopes AJ, Farias ML. Impact of a 6-month treatment with intragastric balloon on body composition and psychopathological profile in obese individuals with metabolic syndrome. Diabetol Metab Syndr. 2016 Dec 19;8:81. doi: 10.1186/s13098-016-0197-6. eCollection 2016.
Clinical trial NCT02681133: How is Physical Activity Level and Educational Expectations of Patient With Knee Osteoarthritis : Epidemiological Study in Spa Therapy
Official title: How is Physical Activity Level and Educational Expectations of Patient With Knee Osteoarthritis : Epidemiological Study in Spa Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Knee Osteoarthritis
Physical Activity
Keywords: Physical activity level
Knee osteoarthritis
Non pharmacological treatment
Survey
Socio-demographic, clinical variables
Barriers, facilitators Fears and beliefs
Function
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: Innovatherm
First posted: 2016-02-12
Enrollment: 500
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with knee pain reported to osteoarthritis

Brief summary: The primary purpose is to evaluate the level of physical activity in patients with knee osteoarthritis in a spa treatment and doing epidemiological study about this patient.

Detailed description: Explain the physical activity level of knee osteoarthritis by socio-demographic, clinical variables, barriers and facilitators of regular physical activity practice, fears and beliefs about their condition, functional limitations and physical inactivity.

Eligibility criteria: Inclusion Criteria:

* Patients, male or female, aged 50 to 75 years.
* Patients with knee pain reported to osteoarthritis
* Patient affiliated to a social security scheme (beneficiary entitled)
* Patient registered spa

Exclusion Criteria:

-

Primary outcomes:
measure: Level of physical activity with IPAQ short form
timeFrame: During the spa treatment
Secondary outcomes:
measure: Socio-demographic variables as assessed by : age, sex, family situation, level of study
timeFrame: During the spa treatment
measure: Fears and beliefs as assessed by KOFBeQ
timeFrame: During the spa treatment
measure: Pain as assessed by EVA
timeFrame: During the spa treatment
measure: Functional status as assessed by WOMAC
timeFrame: During the spa treatment
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU Clermont-Ferrand
Study officials:
References: