louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00217152: A Kidney Transplant Study to Look at the Effects of Taking Fixed Doses of CellCept Versus Taking Doses of CellCept Based on the Concentration of CellCept in the Blood When Taking Full or Reduced Dose Calcineurin Inhibitors
Official title: An Open Label, Prospective, Randomized, Controlled, Multicenter Study Assessing Fixed Dose vs. Concentration Controlled CellCept Regimens for Patients Following a Single Organ Renal Transplantation in Combination With Full Dose and Reduced Dose Calcineurin Inhibitors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Kidney Transplantation
Delayed Graft Function
Keywords: Kidney Transplant
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Roche Pharma AG
First posted: 2005-09-22
Enrollment: 12
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: This research is being done to study the effects (good and bad) of taking CellCept based on blood concentrations versus taking a fixed dose of CellCept without measuring the blood concentration. CellCept is one of the three immunosuppressant drugs (drugs that suppress the immune system) which will be taken as part of this kidney transplant study. Cyclosporine or tacrolimus and corticosteroids are the two other drugs which will be taken.

Detailed description: This study is an open label study, which means the participant will know which drugs they are on. Participants will be put in one of three groups within 24 hours of the participant's transplant. The participant will be asked to return throughout the 24 months for physical exams, blood and urine tests.

Eligibility criteria: Inclusion Criteria:

* Participants must be between 18 and 70 years of age and should be receiving their first or second kidney transplant.

Primary outcomes:
measure: Treatment failure defined as a biopsy proven acute rejection, graft loss, death, or lost to follow-up
timeFrame: during the first 12 months following randomization
measure: Assessment of renal function
timeFrame: 12 months post randomization
Secondary outcomes:
measure: The proportion of patients experiencing biopsy proven acute rejections
measure: The total number of biopsy proven, acute rejection episodes, per patient
measure: The proportion of patients treated for acute rejection
measure: The time to the first proven acute rejection
measure: The time to the treatment failure
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Mark D. Stegall, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00772252: Oxidative Stress and Microcirculation in Patient With Hepatic Failure Undergoing Liver Support Treatment
Official title: Oxidative Stress and Microcirculation in Patient With Hepatic Failure Undergoing Liver Support Treatment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver Failure
Critical Care
Keywords: Liver support treatment
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2008-10-15
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients require liver support treatment

Brief summary: Background: In patients undergoing hemodialysis or hemofiltration will suffer from the injury of reactive oxidative species. Oxidative stress will affect cell membrane, protein, and DNA. It will damage the cell and result in organ dysfunction. We believe that in patients, who have acute hepatic failure, undergoing plasma exchange or Molecular Absorbent Recirculating System for bridge therapy will suffer from the injury of reactive oxidative species, too. It will damage the kidney, lung, cerebral cortex, and other organs. It may result in death before the recovery of liver function or undergoing liver transplantation.

Aims: 1. Investigate the severity of oxidative stress and risk factors of high oxidative stress in acute hepatic failure patient undergoing plasma exchange or Molecular Absorbent Recirculating System. 2. Investigate the microcirculation status and risk factors in acute hepatic failure patient undergoing plasma exchange or Molecular Absorbent Recirculating System. 3. Study the relationship between oxidative stress and microcirculation status. 4. Study the correlation between oxidative stress and prognosis. 5. Study the correlation between microcirculation status and prognosis.


Eligibility criteria: Inclusion Criteria:

1. Age \> 18 years old
2. Patients with acute deterioration on Chronic liver failure, who required liver support treamtment
3. Patients with acute liver failure due to acute hepatitis, who reauired liver support treatment
4. Patients with acute liver dysfunction within 7 days after liver transplantation, who required liver support treatment

Exclusion Criteria:

1. Age \> 70 years old
2. Cancer, not curable
3. Patients who had used of antioxidant therapy within 24 hours before study
4. Patients who had received hyperbaric oxygen therapy within 24 hours before study
5. Patients who had received peroxide treatment within 24 hours before study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Department of Anesthesiology, NTUH
name: Yu-Chang Yeh, Bacehlor
role: STUDY_DIRECTOR
References:
Clinical trial NCT04803552: Non-contact Sleep Apnea Identification in Neurological Rehabilitation
Official title: Identification of Patients With Clinically Relevant Sleep Apnea With a Contactless Device in Rehabilitation Clinic
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sleep Apnea
Stroke
Keywords: stroke
sleep apnea
contactless
screening
Lead sponsor: Sleepiz AG
Sponsor class: INDUSTRY
First posted: 2021-03-17
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: To improve the quality of medical care in the group of poststroke patients, we are planning to examine neurological patients in a rehabilitation clinic simultaneously with a non-contact method (Sleepiz One) and a standard diagnostic polygraphy measurement. This easy and comfortable pre-screening (Sleepiz One) should reduce the barrier for ward physicians to request a sleep study. The method could help to overcome the bottleneck of resource-intense procedures. It is simple to carry out and does not disturb the sleep of the patients.

The scoring is done according to the AASM Manual Version 2.6. Patients with a confirmed diagnosis will be informed about therapy options by a sleep physician and receive a recommendation for further therapy in the discharge letter from the rehabilitation clinic.

The goal of the study is then to evaluate if a non-contact method, the Sleepiz One, presents an opportunity for a fast and easy pre-screening during rehabilitation. Therefore, the precision of binary classification of subjects based on their sleep apnea severity (AHI \>= 15) made by Sleepiz One will be compared to PG data manually scored by expert sleep scorers.


Eligibility criteria: Inclusion Criteria:

* Age \>18years
* Ability and consent to undergo electrophysiological routine assessment
* Informed Consent as documented by signature
* In-patients of RehaClinic Bad Zurzach

Exclusion Criteria:

* Previous enrolment into the current study,
* Enrolment of the investigator, his/her family members, employees and other dependent persons
* Cardiac pacemaker or another implanted electrical device
* Women who are pregnant or breastfeeding
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, delirium etc. of the participant

Primary outcomes:
measure: Binary classification of the apnea severity
timeFrame: 1 night
Secondary outcomes:
Other outcomes:
Locations:
city: Bad Zurzach
country: Switzerland
facility: KSM Bad Zurzach
state: Aargau
Study officials:
affiliation: KSM Bad Zurzach
name: Jens Acker, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02980952: Amino Acid Balance During Physical Inactivity
Official title: Amino Acid Balance During Physical Inactivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Assessing Muscle Amino Acid Balance
Lead sponsor: University of Exeter
Sponsor class: OTHER
First posted: 2016-12-02
Enrollment: 22
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The aim is to assess the impact of physical inactivity on muscle amino acid balance and forearm glucose uptake. In addition, we will evaluate how high-fat overfeeding will modulate muscle amino acid balance and forearm glucose uptake.

Detailed description: The aim is to assess the impact of forearm cast immobilization on muscle amino acid balance and forearm glucose uptake. In addition, we will evaluate how high-fat overfeeding during immobilization will modulate muscle amino acid balance and forearm glucose uptake.

Eligibility criteria: Inclusion Criteria:

* BMI between 18 and 30

Exclusion Criteria:

* Any diagnosed metabolic impairment (e.g. type 1 or 2 Diabetes).
* Any diagnosed cardiovascular disease or hypertension.
* Elevated blood pressure at the time of screening. (An average systolic blood pressure reading of ≥140 mmHg over two or more measurements and an average diastolic blood pressure of ≥90 mmHg over two or more measurements.)
* Chronic use of any prescribed or over the counter pharmaceuticals.
* Regular use of nutritional supplements (e.g. creatine, protein supplementation)
* Metallic implants (including heart pacemaker, cochlear implants, medication pumps, surgical clips, plates or screws).
* A personal or family history of thrombosis, epilepsy, seizures or schizophrenia.
* Any previous motor disorders.

Primary outcomes:
measure: Muscle amino acid balance
timeFrame: 3 hours
Secondary outcomes:
measure: Glucose uptake
timeFrame: 3 hours
Other outcomes:
Locations:
Study officials:
affiliation: University of Exeter
name: Benjamin T Wall, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wall BT, Cruz AM, Otten B, Dunlop MV, Fulford J, Porter C, Abdelrahman DR, Stephens FB, Dirks ML. The Impact of Disuse and High-Fat Overfeeding on Forearm Muscle Amino Acid Metabolism in Humans. J Clin Endocrinol Metab. 2020 Jul 1;105(7):dgaa184. doi: 10.1210/clinem/dgaa184.
citation: Dirks ML, Wall BT, Otten B, Cruz AM, Dunlop MV, Barker AR, Stephens FB. High-fat Overfeeding Does Not Exacerbate Rapid Changes in Forearm Glucose and Fatty Acid Balance During Immobilization. J Clin Endocrinol Metab. 2020 Jan 1;105(1):dgz049. doi: 10.1210/clinem/dgz049.
Clinical trial NCT04899752: Motivational Interviewing & Clinician Centered Interviewing on Cardiac Rehab
Official title: The Effect of Motivational Interviewing and Clinician Centered Interviewing Based Cardiac Rehabilitation on Core Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Rehabilitation
Motivational Interviewing
Lead sponsor: Auburn University
Sponsor class: OTHER
First posted: 2021-05-24
Enrollment: 89
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are randomly assigned to one of three groups.
Primary purpose: TREATMENT

Brief summary: The purpose of this project is to examine the differences in outpatient cardiac rehab (OPCR) core component outcomes on different intervention conditions. Conditions include traditional OPCR (control), OPCR + motivational interviewing (MI) and OPCR + Clinician centered interviews.

Detailed description: Participants who are beginning a OPCR program at a local hospital are eligible for the program. During the standard admission procedures, eligible participants will be provided with a consent from and asked to participate in the study. Participants who provide consent will complete their admission packet. The standard admission packet includes: the Outpatient Fall Assessment Risk, Patient Health Questionnaire (PHQ-9),the Dartmouth Quality of Life, and the Rate Your Plate. In addition participants will complete three additional surveys: the Intrinsic Motivation Inventory (IMI), the FPS, (FACES Pain Scale), and the Brief Resilience Scale (BRS). During their second appointment participants will complete the standard 6 minute walk test which is scheduled at their convenience and the grip strength. Participants will then be randomly assigned to the traditional OPCR, the OPCR + MI, or the OPCR - Clinician centered. Post-testing will include all baseline information as well as information from patients charts (lipid profile, HbA1c, risk factors and family history). Analysis will determine differences in core outcomes between the three groups.

Eligibility criteria: Inclusion Criteria:

* Enrolled in outpatient cardiac rehab
* Able to complete the paperwork independently

Exclusion Criteria:

* Unable to complete assessments and paperwork independently.

Primary outcomes:
measure: Adherence to CR
timeFrame: 12 weeks
measure: 6-minute walk
timeFrame: 12 weeks
measure: Rate my plate
timeFrame: 12 weeks
measure: Dartmouth Quality of Life index
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Auburn
country: United States
facility: Auburn University
state: Alabama
Study officials:
affiliation: Auburn University
name: Danielle D Wadsworth, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04358952: Myocardial Involvement of Severe Acute Respiratory Syndrome-Cov-2 (Covid19) Infected Patients
Official title: Imaging Cardiac Phenotype of SARS-Cov-2 (Covid19) Infected Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiomyopathies
Keywords: Left ventricular systolic function
left ventricular diastolic function
global longitudinal strain
SARS-Cov-2
Covid-19
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2020-04-24
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Major patients hospitalized for respiratory criteria for SARS-Cov-2 infection confirmed by RT-PCR

Brief summary: The effects of severe acute respiratory syndrome SARS-Cov-2 (Covid-19) on the myocardium and their role in the clinical course of infected patients are still unknown. Epidemiological studies report biological myocardial involvement in 10 to 25% of cases. The objective of this study is to cardiac phenotype using comprehensive cardiac imaging tools of patients infected with Covid 19 in order to explore the functional impact of the infection on the myocardium.

Detailed description: A large population of Covid 19 infected patients of different ages and severity levels will be explored by transthoracic echocardiography with measurement of myocardial functional parameters such as ejection fraction, longitudinal strain and relaxation parameters and will be compared to an uninfected population paired for age and sex.

Patients with biological myocardial involvement will be followed to determine the evolution of their myocardial functional parameters during the course of the infection.

Eligibility criteria: Inclusion Criteria:

* Major patients hospitalized for respiratory criteria for SARS-Cov-2 infection confirmed by RT-PCR

Exclusion Criteria:

* Underage patients. Patients refusing to participate in research. Patients with a history of heart disease.

Primary outcomes:
measure: Left ventricular function
timeFrame: Day 0
measure: Left ventricular function
timeFrame: Day 3
measure: Left ventricular function
timeFrame: Day 7
Secondary outcomes:
measure: inflammatory biological parameters
timeFrame: Day 0
Other outcomes:
Locations:
city: Toulouse
country: France
facility: UHToulouse
Study officials:
affiliation: University Hospital, Toulouse
name: Vincent MINVILLE, PU-PH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lairez O, Blanchard V, Balardy L, Vardon-Bounes F, Cazalbou S, Ruiz S, Collot S, Houard V, Rolland Y, Conil JM, Minville V. COCARDE Study-Cardiac Imaging Phenotype in Patients With COVID-19: Protocol for a Prospective Observational Study. JMIR Res Protoc. 2022 Jan 6;11(1):e24931. doi: 10.2196/24931.
Clinical trial NCT04930952: Complications of Ethanol-amine Oleate Intralesional Sclerotherapy
Official title: Complications of Ethanol-amine Oleate Intralesional Sclerotherapy Injections of Maxillofacial Venous Malformations in Pediatric Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Venous Malformation
Keywords: Maxillofacial
Pediatric
Venous Malformations
Ethanol-amine Oleate
Lead sponsor: Suez Canal University
Sponsor class: OTHER
First posted: 2021-06-18
Enrollment: 15
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Pediatric patients of age up to 12 years having maxillofacial venous malformations

Brief summary: The aim of this study is to clarify complications of Ethanolamine Oleate intralesional injections of maxillofacial venous formations in pediatric patients

Detailed description: Maxillofacial Venous malformations cause many functional and esthetic complications in children, intralesional sclerotherapy is the best choice of treatment; and Ethanol-amine Oleate has been the most commonly used sclerosing agent.

The aim of this study is to clarify complications of Ethanolamine Oleate intralesional injections of maxillofacial venous formations

Eligibility criteria: Inclusion Criteria: maxillofacial venous malformation

-

Exclusion Criteria:

1. Patients with lung, liver, or kidney diseases
2. Patients with Klippel-Trenaunay syndrome
3. Patients mental or physical disabilities

Primary outcomes:
measure: Clinical Response
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ismailia
country: Egypt
facility: Suez Canal University
Study officials:
affiliation: Assistant Lecturer
name: Sarah Arafat, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04481152: Impact of Environmental Exposures on Tumor Risk in Subjects at Risk of Hereditary SDHx Paraganglioma
Official title: Impact of Environmental Exposures on Tumor Risk in Subjects at Risk of Hereditary SDHx-related Paragangliomas, Pilot Phase
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Genetic Predisposition
SDH Gene Mutation
Environmental Exposure
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
name: ANSES
First posted: 2020-07-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 50 cases and 50 controls will be enrolled in a single referral center where they are regurlarly managed and followed for a SDHx-related tumor risk. They will be matched on their date of birth

Brief summary: The main objective of the pilot phase of PGLEXPO will be to assess the faisability and to precise methodology of a case-control study designed for testing the impact of environmental and professional exposures on the tumoral risk in SDHx-mutation carriers

Detailed description: The main objective of the pilot phase of PGLEXPO will be to assess the faisability and to precise methodology of a case-control study designed for testing the impact of environmental and professional exposures on the tumoral risk in SDHx-mutation carriers.

Patients will be selected from subjects with a mutation in one of the SDHx genes. The cases will have developed a tumor, while the controls will be tumor-free. Controls will be matched to the cases according to sex, age and type of gene affected. Past exposures will be sought through a telephone questionnaire.

Eligibility criteria: Inclusion Criteria:

1. Cases: SDHx mutation carriers diagnosed for a SDHx-related tumor
2. Controls: SDHx mutation carriers with no SDHx-related tumor

Exclusion Criteria:

Incapacity to exercise free and informed consent for the study

Primary outcomes:
measure: Feasability of the protocol of a national case/control study (PGL.EXPO2)
timeFrame: 2 years
Secondary outcomes:
measure: Feasibility of matching cases and controls
timeFrame: 2 years
measure: Ease of matching cases and controls
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Anne-Paule GIMENEZ-ROQUEPLO, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00002452: A Study on the Safety and Effectiveness of L-756423 Plus Indinavir in HIV-Positive Patients Who Have Previously Taken Indinavir
Official title: A Multicenter, Open-Label, Pilot Study to Evaluate the Safety and Activity of L-756423/Indinavir Sulfate, 800/400 Mg b.i.d. in Combination With Two nRTIs in HIV-Infected Patients Who Failed an Indinavir Containing Regimen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV Infections
Keywords: Drug Therapy, Combination
HIV Protease Inhibitors
Indinavir
Reverse Transcriptase Inhibitors
Anti-HIV Agents
Viral Load
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see if L-756423, an anti-HIV drug, is safe to give with indinavir and if it works well at lowering the level of HIV in the blood (viral load).

Detailed description: All patients receive L-756423 plus indinavir plus two licensed nucleoside reverse transcriptase inhibitors (NRTIs), at least one to which the patient is naive. Patients remain on the drug regimen for 12 weeks (with possible extension to 16 weeks). Patients are evaluated with physical examinations and laboratory tests for blood and urine at Weeks 1, 2, 4, 6, 8, and 12 and two weeks post study. Plasma viral RNA is measured at Weeks 1, 2, 4, 6, 8, and 12. CD4 cell counts are measured at Weeks 2,4,8, and 12.

Eligibility criteria: Inclusion Criteria

You may be eligible for this study if you:

* Are HIV-positive.
* Are at least 18 years old.
* Have a viral load of at least 1,000 copies/ml.
* Have a CD4 cell count of at least 100 cells/mm3.
* Have experienced treatment failure (your viral load increased significantly) within 24 weeks of study entry while taking indinavir.

Exclusion Criteria

You will not be eligible for this study if you:

* Are taking nonnucleoside reverse transcriptase inhibitors (NNRTIs).

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Univ of Alabama at Birmingham
state: Alabama
city: Washington
country: United States
facility: Georgetown Univ
state: District of Columbia
city: Atlanta
country: United States
facility: AIDS Research Consortium of Atlanta
state: Georgia
city: Honolulu
country: United States
facility: Hawaii AIDS Clinical Trial Unit
state: Hawaii
city: Chicago
country: United States
facility: The CORE Ctr
state: Illinois
city: New York
country: United States
facility: Cornell Clinical Trials Unit - Chelsea Clinic
state: New York
city: Pittsburgh
country: United States
facility: Pittsburgh Treatment Ctr / Univ of Pittsburgh
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt Univ Med Ctr
state: Tennessee
Study officials:
References: