louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01558895: Infrared Ray Heat Treatment in Liver Cirrhosis Patients With Refractory Ascites
Official title: Infrared Ray Heat Treatment in Hepatic Area in Liver Cirrhosis Patients With Refractory Ascites
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Liver Cirrhosis
Refractory Ascites
Keywords: Infrared ray heat treatment
liver cirrhosis
refractory ascites
Lead sponsor: First People's Hospital of Foshan
Sponsor class: OTHER
First posted: 2012-03-20
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to evaluate the therapeutic efficacy of Infrared ray heat treatment in hepatic area in cirrhosis patients with refractory ascites. The evaluation of the efficacy includes the ascites pressure, portal vein velocity，SAAG before and after the treatment. Clinical symptoms were also observed simultaneously.


Eligibility criteria: Inclusion Criteria:

* Male
* aged 18\~60 years
* inpatient
* Diagnosed with liver cirrhosis and liver stubborn ascites.

Exclusion Criteria:

* Severe problems in other vital organs(e.g.the heart,renal or lungs).
* combined with malignant tumour.
* combined with endocrine diseases.
* combined with high fever.
* infected with the AIDS virus

Primary outcomes:
measure: ascites pressure
timeFrame: 30 min
Secondary outcomes:
Other outcomes:
Locations:
city: Foshan
country: China
facility: The first people's hospital of Foshan
state: Guangdong
Study officials:
affiliation: First People's Hospital of Foshan
name: Yinong Ye, doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02943395: Color Stability of E.Max CAD Laminate Veneers Cemented With Light Cure Versus Dual Cure Amine Free Adhesive Resin Cement
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Tooth Discoloration
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2016-10-24
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Light curing cements used for laminate veneers may be not totally cured in certain areas, so dual cured resin cements may solve this problem yet the dual cured cements containing amines cause yellowish discoloration of the veneers after time.

A new dual cured cement which is amine free is introduced so the investigators have to try it clinically using parallel groups in randomized clinical trial.


Eligibility criteria: Inclusion Criteria:

All subjects are required to be:

* From 18-60 years old, and able to read and sign the informed consent document
* physically and psychologically able to tolerate conventional restorative procedures
* Have no active periodontal or pulpal diseases, have teeth with good restorations
* Patients with teeth problems indicated for laminate veneer (e.g. discoloration, fracture not involve more than 50% enamel loss, mild malposition, ....)
* Willing to return for follow-up examinations and evaluation

Exclusion Criteria:

* Patients in the growth stage with partially erupted teeth
* Patient with fractured teeth of more than 50% enamel loss
* Patients with poor oral hygiene and motivation
* Pregnant women
* Psychiatric problems or unrealistic expectations
* Lack of opposite occluding dentition in the area intended for restoration

Primary outcomes:
measure: Color stability assessed clinically using easy shade vita device
timeFrame: 1 Year
Secondary outcomes:
measure: Patient satisfaction assessed using a Questionnaire
timeFrame: 1 Year
Other outcomes:
Locations:
Study officials:
References:
citation: Magalhaes AP, Cardoso Pde C, de Souza JB, Fonseca RB, Pires-de-Souza Fde C, Lopez LG. Influence of activation mode of resin cement on the shade of porcelain veneers. J Prosthodont. 2014 Jun;23(4):291-5. doi: 10.1111/jopr.12098. Epub 2013 Oct 7.
citation: Gresnigt MM, Kalk W, Ozcan M. Clinical longevity of ceramic laminate veneers bonded to teeth with and without existing composite restorations up to 40 months. Clin Oral Investig. 2013 Apr;17(3):823-32. doi: 10.1007/s00784-012-0790-5. Epub 2012 Jul 21.
Clinical trial NCT02051595: The Effects of Modified Ultrafiltration on Vancomycin Levels During Cardiopulmonary Bypass in Cardiac Surgery
Official title: The Effects of Modified Ultrafiltration on Vancomycin Levels During Cardiopulmonary Bypass in Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Infection
Keywords: heart lung machine
blood pump
cardiac surgery
cardiopulmonary bypass
circulation
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2014-01-31
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Antibiotics are routinely used to prevent surgical wound infection. Vancomycin is a widely used antibiotic for surgery in patients with an allergy to penicillin. During cardiac surgery, cardiopulmonary bypass (CPB) and modified ultrafiltration (MUF) are routinely used and can lower the level of the antibiotic. The purpose of this study is to quantify the change in plasma vancomycin concentration associated with cardiopulmonary bypass and modified ultrafiltration.

Detailed description: Subjects having cardiac surgery in which they will be on a heart-lung machine and will receive the antibiotic vancomycin, will be able to participate.

Up to ten blood samples testing for vancomycin concentrations will be collected in subjects administered vancomycin as prophylaxis before cardiac surgery with cardiopulmonary bypass and modified ultrafiltration. Participation will be complete once the cardiac surgery has been finished.

Eligibility criteria: Inclusion Criteria:

* Scheduled to undergo cardiac surgery with cardiopulmonary bypass and modified ultrafiltration
* age greater than 18 years old
* penicillin allergy or in-hospital stay greater than 24 hours
* normal renal function
* normal liver function
* absence of clinical and laboratory signs of infection

Exclusion Criteria:

* vancomycin allergy
* pregnancy
* impaired renal function
* impaired liver function
* morbid obesity
* active infections
* Jehovah's Witness

Primary outcomes:
measure: Circulating Vancomycin Concentration
timeFrame: Time points: pre CPB (t=1), post CPB at 5 (t=2), 30 (t=3), 60 (t=4), 108 (t=5), 240 (t=6) minutes, prior to ultrafiltration (t=7), end of ultrafiltration (t=8), ultrafiltrate (t=9) ,effluent of cell saver (t=10)
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF Health
state: Florida
Study officials:
affiliation: University of Florida
name: Ettore Crimi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04495595: Influence of the Biological Maturation on the Antrhopometric Variables and Sport Performance in Volleyball Players
Official title: Influence of the Biological Maturation on the Antrhopometric Variables and Sport Performance in Volleyball Players
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Development, Adolescent
Body Weight Changes
Keywords: Sport performance
Volleyball
Anthropometry
Biological maturation
Lead sponsor: Universidad Católica San Antonio de Murcia
Sponsor class: OTHER
First posted: 2020-08-03
Enrollment: 213
Sex: ALL
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The sample objetive of the present study are all the volleyball players of Región of Murcia, Spain, that meet the inclusion criteria and voluntarily decide to take part in the study.

Brief summary: The project consists of a cross-sectional study in which anthropometric variables, general and specific performance variables of volleyball will be measured, and the biological maturity stage will be calculated. The main objective is to establish a relationship between the biological maturation state, the anthropometric characteristics and the performance in physical fitness tests in volleyball players between 12 and 15 years of age. To do this, there will be all the clubs in the Region of Murcia that have federated teams in these categories.


Eligibility criteria: Inclusion Criteria:

* To play volleyball in a regular basis
* To have between 12 and 15 years
* To participate in volleiball competitions with the team

Exclusion Criteria:

* To be injured in the moment of the measurement session
* To have skipped most of the training sessions the last month
* To have less than a year of experience playing volleyball

Primary outcomes:
measure: Volleyball performance
timeFrame: through study completion, an average of 1 year
measure: Biological maturation
timeFrame: through study completion, an average of 1 year
measure: Muscle mass
timeFrame: through study completion, an average of 1 year
measure: Fat mass
timeFrame: through study completion, an average of 1 year
measure: Bone mass
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Universidad Católica San Antonio
Study officials:
References:
Clinical trial NCT00217295: A Safety Study of Combination Treatment With Avonex and Placebo-Controlled Dosing of Topamax in Relapsing-Remitting Multiple Sclerosis
Official title: A Safety Study of Combination Treatment With Avonex and Placebo-Controlled Dosing of Topamax in Relapsing-Remitting Multiple Sclerosis.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Multiple Sclerosis
Keywords: Relapsing-remitting multiple sclerosis
Brain atrophy
Disease progression
Lead sponsor: Multiple Sclerosis Institute
Sponsor class: OTHER
First posted: 2005-09-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a clinical trial in relapsing-remitting Multiple Sclerosis to determine if Topamax added to Avonex has a neuroprotective effect as measured by the brain parenchymal fraction ( a measure of brain shrinkage) and by clinical assessment scores to evaluate disease progression.

Detailed description: The protocol requires all participants to be treated with Avonex and in addition patients will be blindly assigned to either a group who receive Topamax or a placebo control. Repeated neurological and clinical examinations are performed with laboratory tests to determine any possible adverse drug effects. The scaled neurologic examinations (EDSS and MSFC) and brain MRI's are done at regular intervals to evaluate possible treatment effects.

Eligibility criteria: Inclusion Criteria:

Relapsing-remitting multiple sclerosis

-

Exclusion Criteria:

Secondary progressive multiple sclerosis Contraindication to MRI Systemic disease Pregnancy -

Primary outcomes:
measure: Safety and tolerability
Secondary outcomes:
measure: Brain atrophy on nMRI
measure: Disease progression on EDSS and MSFC
measure: Relapse rate
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Multiple Sclerosis Institute
state: Pennsylvania
Study officials:
affiliation: MSI
name: Jeffrey I Greenstein, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01968395: Pharmacokinetics of Caspofungin After One Dose in Patients With Liver Failure
Official title: Pharmacokinetics of Caspofungin After One Dose in Patients With Liver Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bacterial Infections and Mycoses
Liver Disease
Lead sponsor: Erasme University Hospital
Sponsor class: OTHER
First posted: 2013-10-24
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The objective of this study is to conduct a population pharmacokinetic analysis of caspofungin in a population of patients with moderate and severe acute alcoholic hepatitis or liver disease with Child-Pugh score B and C in order to better characterize pharmacokinetic parameters in case of moderate and severe liver dysfunction.

Detailed description: patients admitted for alcoholic hepatitis or decompensated cirrhosis and Child-Pugh score 7-9 and 10-15 will be included; all patients without invasive aspergillosis.

Eligibility criteria: Inclusion Criteria:

* Liver failure Child-Pugh B and C

Exclusion Criteria:

* Cachexia (BMI \< 15 kg/m²)
* Pregnancy
* HIV
* Hepatitis C patients

Primary outcomes:
measure: Measurement of serum caspofungine concentrations to determine the pharmacokinetic parameters of Caspofungin in patients with liver failure
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Erasme University Hospital
Study officials:
affiliation: Erasme University Hospital
name: Frédérique JACOBS, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gustot T, Ter Heine R, Brauns E, Cotton F, Jacobs F, Bruggemann RJ. Caspofungin dosage adjustments are not required for patients with Child-Pugh B or C cirrhosis. J Antimicrob Chemother. 2018 Sep 1;73(9):2493-2496. doi: 10.1093/jac/dky189.
Clinical trial NCT00435695: Study Of Safety, Blood Levels, And Brain Receptor Occupancy Of GSK163090 Using PET Imaging In Healthy Males
Official title: An Open Label, Non-randomized Positron Emission Tomography Study in Healthy Male Subjects to Investigate Brain 5-HT1A Receptor Occupancy, Pharmacokinetics and Safety of Single Oral Doses of GSK163090, Using the Ligand [11C]-WAY100635.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Depressive Disorder and Anxiety Disorders
Keywords: PET scan
healthy males
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-02-15
Enrollment: 13
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to look at how much of a new drug, GSK163090, binds to proteins in the brain and how much stays in the blood over a range of different doses. This study will use a medical imaging technique called Positron Emission Tomography (PET) which uses an imaging agent called \[11C\]-WAY100635.


Eligibility criteria: Inclusion Criteria:

* Healthy male subjects, aged 18-45 years Body weight \> 50 kg
* Non-Smoker
* Normal ECG, heart rate and blood pressure

Exclusion Criteria:

* History of any cardiac disease
* History of regular alcohol consumption averaging \>14 drinks/week
* Current or recent gastrointestinal disease; History of psychiatric illness including any history of suicidal attempts
* Positive for Hepatitis B and C, and HIV.
* History of drug abuse.
* Exposure to research and/or medical protocol involving nuclear medicine, PET or radiological investigations with significant radiation burden
* Family history of cancer (one or more first-degree relative diagnosed before the age of 55).
* Suffers from claustrophobia
* History or presence of neurological or psychiatric conditions
* Presence of a cardiac pacemaker or other implanted electronic device or metal implants

Primary outcomes:
measure: Brain receptor occupancy of GSK163090 Plasma concentrations of GSK163090
timeFrame: throughout the study
Secondary outcomes:
measure: Vitals signs ECGs Clinical Laboratory test results
timeFrame: throughout the study
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: GSK Investigational Site
state: Ontario
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT05899595: Effects of a Personalized Physical Training to Reduce Fatigue
Official title: Effects of a Personalized Physical Training to Reduce Fatigue in Chronic Fatigue Patients: a Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Fatigue Syndrome, Chronic
Keywords: Fatigue
Neuromuscular function
Personalized training
Physical capacity
Fatigue status
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: Laboratoire Interuniversitaire de Biologie de la Motricité
First posted: 2023-06-12
Enrollment: 130
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: Chronic fatigue (CF) is a pathological fatigue over at least 6 months, without improvement after rest or sleep. In primary care, it is the major complaint in 5 to 10% of the consultations. Physical activity is an efficient therapy to help reducing this fatigue in addition to the improvement of muscular and cardiorespiratory functions. However, it remains little exploited. Yet the studies focus mainly on precise chronic pathologies with general trainings, without considering the fatigue status and reveal a large heterogeneity. Personalizing the physical training appears to be the next step in order to improve chronic fatigue patients care.

The objective of this study will be to investigate the relevance and the effects of a personalized physical training to reduce fatigue in chronic fatigue patients.


Eligibility criteria: Inclusion Criteria:

* Aged ≥ 18
* Men or women
* FACIT-F score ≤ 34
* Ability to walk during 10 minutes without stopping
* Ability to receive the Myocene® stimulation protocol
* Have given written consent
* Members or beneficiaries of a social security program

Exclusion Criteria:

* Contraindication to experimental procedures
* Important health issues that would compromise the participant security during the study
* Persistent atrial fibrillation or 2nd or 3rd degree atrioventricular block
* Currently participating in an other interventional study or having so in the past thirty days
* Patient is pregnant
* Patient is unable to give an informed consent
* Patient is deprived of liberty or under guardianship

Primary outcomes:
measure: The primary outcome is the change in the FACIT-F score obtained before and after the exercise procedure.
timeFrame: Month 1, 4
Secondary outcomes:
Other outcomes:
Locations:
city: Saint-Etienne
country: France
facility: Centre Hospitalier de Saint-Etienne
Study officials:
affiliation: CHU SAINT-ETIENNE
name: David HUPIN, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01042795: Trial of Adjuvant Sutent for Patients With High Risk Urothelial Carcinoma After Neoadjuvant Chemotherapy and Cystectomy
Official title: Phase II Trial of Adjuvant Sutent for Patients With High Risk Urothelial Carcinoma After Neoadjuvant Chemotherapy and Cystectomy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Urothelial Carcinoma
Bladder Cancer
Keywords: sunitinib
bladder neoplasm
adjuvant treatment
disease free survival
cystectomy
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2010-01-06
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether sutent (sunitinib)is effective in preventing tumor recurrence in patients with high risk bladder cancer who have previously had chemotherapy and cystectomy (bladder removal).

A 4 month supply of the drug is given to patients beginning 2-3 months after bladder removal. The patients are followed up to 2 years.


Eligibility criteria: Inclusion Criteria:

* Histologic diagnosis of bladder carcinoma (\>50% urothelial carcinoma)
* Prior treatment with at least one cycle of platin-based neoadjuvant chemotherapy
* Prior treatment with radical cystectomy revealing pT3NxM0 or pTanyN+M0
* ECOG performance status of 0-1 (Appendix 2).
* No evidence of metastases within 4 weeks of registration
* Adequate organ and marrow function obtained within 14 days of registration

Exclusion Criteria:

* Severe or uncontrolled acute or chronic medical or psychiatric condition
* Prior antiangiogenic therapy
* Prior pelvic radiation for bladder cancer

Primary outcomes:
measure: Disease Free Survival
timeFrame: 2- year
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
References:
Clinical trial NCT04213495: Czech Anesthesia Day 2019
Official title: Czech Anesthesia Day 2019: Observational Trial
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anesthesia Practice
Keywords: Anesthesia
Practice
Czech Republic
Lead sponsor: Brno University Hospital
Sponsor class: OTHER
Collaborators: name: Krajská zdravotní a.s. University Hospital Ústí nad Labem
First posted: 2019-12-30
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing surgical or diagnostic procedure under anesthesia in the Czech Republic

Brief summary: Czech Anesthesia Day 2019 was designed as a prospective observational trial with the aim to evaluate the current anesthesiology practice in Czech Republic.

Detailed description: Anesthesiology centers in Czech Republic was screened for cooperation during the year 2018. Data from centers with previously confirmed cooperation will be screened and filled into the electronic database. The basic information about the centre, patient´s demography, American Society of Anesthesiologist classification (ASA), type of surgery/anesthesia, airway management, type of anesthesia induction, drugs for anesthesia induction a and anesthesia maintenance, used monitors of vital signs and functions, type and amount of infusions, temperature management, intravenous lines management, patient blood management, mechanical ventilation settings and postoperative admission will be recorded.

Eligibility criteria: Inclusion Criteria:

* Patients from confirmed Anesthesiology Centers - previously confirmed the cooperation (center is registered in the online database with the unique identification)

Exclusion Criteria:

* Data from centers with not confirmed cooperation

Primary outcomes:
measure: Anesthesia description
timeFrame: From anesthesia induction until the admission to postanesthesia care
Secondary outcomes:
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: Brno University Hospital
state: South Moravian Region
city: Ústí Nad Labem
country: Czechia
facility: Krajska zdravotni a.s. University Hospital Usti nad Labem
Study officials:
affiliation: University Hospital Brno
name: Petr Stourac, assoc.Prof.MD.Ph.D
role: STUDY_CHAIR
affiliation: Krajska zdravotni a.s. University Hospital Usti nad Labem
name: Vladimir Cerny, Prof.MD.Ph.D.
role: STUDY_DIRECTOR
References: