louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01160120: Therapeutic Drug Monitoring (TDM) in Generic Tenofovir/Lamivudine/Efavirenz
Official title: Generic Fixed Dose Combination (FDC) of Tenofovir(TDF) /Lamivudine(3TC)/Efavirenz (EFV) Tablets 300/300/600 mg
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV
Keywords: fixed dose combinations
tenofovir
lamivudine
efavirenz
therapeutic drug levels
safety and efficacy
HIV
To evaluation new formulations of FDC of TDF/3TC/EFV
Lead sponsor: The HIV Netherlands Australia Thailand Research Collaboration
Sponsor class: OTHER
Collaborators: name: Mylan Laboratories
First posted: 2010-07-12
Enrollment: 100
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 purpose of this study is to determine the mid levels of the tenofovir, lamivudine, and efavirenz, and 144 weeks safety and efficacy of the generic fixed dose combination of tenofovir /lamivudine/efavirenz tablets 300/300/600 mg in Thai HIV-infected patients.

Detailed description: The trial drug FDC of TDF/3TC/EFV is a new formulation combining fixed doses of the nucleoside reverse transcriptase inhibitors lamivudine 300 mg and tenofovir disoproxil fumarate 300 mg with the non nucleoside reverse transcriptase inhibitor efavirenz 600 mg for once daily and one-tablet HAART. Co-formulated TDF/3TC/EFV demonstrated bioequivalent to original individual EFV 3TC and TDF in Indian healthy volunteers (unpublished data). It has not been evaluated in clinical trials.

Eligibility criteria: Inclusion Criteria:

* Signed informed consent
* Evidence of HIV infection
* Age\> 18 years
* On a TDF/3TC/EFV (separated pills) containing HAART regimen with a VL \< 50 copies within 24 weeks or ARV naïve
* eGFR \>70 cc/min
* Currently having no AIDS defining illness
* No history of NRTI/NNRTI/PI failure
* Willing to adhere to the protocol requirements

Exclusion Criteria:

* Any history of taking CYP450 inhibitors or inducers drugs within 14 days of enrollment in the study
* Current pregnancy or lactating or plan to be pregnant
* Active opportunistic infection
* ALT more than 2 x upper limit
* Creatinine more than 1.5 time the upper limit
* Active drug abuse

Primary outcomes:
measure: mid levels of TDF, 3TC, and EFV between brand and generic
timeFrame: 144 weeks
Secondary outcomes:
measure: kidney, liver, CD4 and viral load overtime
timeFrame: 144 weeks
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: HIV-NAT
Study officials:
affiliation: The HIV Netherlands Australia Thailand Research Collaboration
name: Anchalee Avihingsanon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Avihingsanon A, Sophonphan J, Thammajaruk N, Chaihong P, Burger D, Cressey TR, Ramautarsing RA, Praditornsilpa K, Avihingsanon Y, Ruxrungtham K and HIV-NAT 114 study team. Plasma Tenofovir Concentrations and Proximal Tubular Dysfunction in HIV-Infected Adults Receiving Tenofovir in Thailand. AIDS Clin Res 2015, 6:7 Doi: http://dx.doi.org/10.4172/2155-6113.1000477
Clinical trial NCT05238220: Utilization of the Viracor® Assay for Valganciclovir Prophylaxis in CMV High Risk Kidney Transplant Recipients
Official title: Utilization of the Viracor® Assay in Directing Duration of Valganciclovir Prophylaxis in CMV High Risk Kidney Transplant Recipients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Transplant; Complications
Lead sponsor: Piedmont Healthcare
Sponsor class: OTHER
Collaborators: name: ViraCor Laboratories
First posted: 2022-02-14
Enrollment: 37
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: CMV High Risk Kidney Transplant Recipients

Brief summary: The purpose of this study is to evaluate whether the use of the Viracor® CMV immunity assay at 6 months post-transplant in CMV high risk kidney transplant recipients would help identify those patients at higher risk of post-prophylaxis CMV viremia or disease and thereby select those patients in which a longer duration of valganciclovir prophylaxis would be beneficial.

Detailed description: Kidney transplant patients that are cytomegalovirus (CMV) seronegative (IgG negative) at time of transplant and receive a graft from a donor that is CMV seropositive (IgG positive) are at increased risk of developing post-transplant CMV viremia and disease. These patients receive standard CMV prophylaxis with valganciclovir for 6 months post-transplant. However, a considerable proportion of these patients (25 - 42% at our center over the last 5 years) will go on to develop CMV viremia and/or disease after this valganciclovir prophylaxis is discontinued. To date, there is no strong data regarding whether certain patients would benefit from extension of valganciclovir prophylaxis beyond the standard 6-month period.

The purpose of this study is to evaluate whether the use of the Viracor® CMV immunity assay at 6 months post-transplant in CMV high risk kidney transplant recipients would help identify those patients at higher risk of post-prophylaxis CMV viremia or disease and thereby select those patients in which a longer duration of valganciclovir prophylaxis would be beneficial.

Eligibility criteria: Inclusion Criteria:

* Able to provide consent
* Kidney Transplant Recipients
* Classified as CMV high risk at time of transplant (donor CMV IgG positive and recipient CMV IgG negative)

Exclusion Criteria:

* none

Primary outcomes:
measure: Use of Viracor CMV immunity assay
timeFrame: 6 months post-transplant through 12 months prophylaxis
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Piedmont Atlanta Hospital
state: Georgia
Study officials:
References:
Clinical trial NCT03190720: Development of Exercise Promotion Program Using a Mobile Community
Official title: Development of Exercise Promotion Program Using a Mobile Community Based on a Smart Phone Application in Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Physical Activity
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2017-06-19
Enrollment: 64
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two different single-arm study
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aims to investigate the effect of a mobile community based on a smart phone application to enhance physical activities of breast cancer survivors.


Eligibility criteria: Inclusion Criteria:

* Stage 0-III breast cancer

Exclusion Criteria:

* Stage IV breast cancer
* Breast cancer recurrence or metastasis
* Severe medical illness

Primary outcomes:
measure: Distress
timeFrame: up to 3months
Secondary outcomes:
measure: Physical activity
timeFrame: up to 3months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
state: Korea
Study officials:
References:
citation: Chung IY, Jung M, Park YR, Cho D, Chung H, Min YH, Park HJ, Lee M, Lee SB, Chung S, Son BH, Ahn SH, Lee JW. Exercise Promotion and Distress Reduction Using a Mobile App-Based Community in Breast Cancer Survivors. Front Oncol. 2020 Jan 10;9:1505. doi: 10.3389/fonc.2019.01505. eCollection 2019.
Clinical trial NCT00543920: A Study of MK0777 in the Treatment of Outpatients With Generalized Anxiety Disorder (0777-020)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Anxiety Disorders
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-10-15
Enrollment: 60
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: The study will look at the effect of MK0777on reducing anxiety in subjects with general anxiety disorder.

This is an early phase trial and some specific protocol information is in progress and not publicly available at this time. (Full information is available to trial participants).


Eligibility criteria: Inclusion Criteria:

* Diagnosis of General Anxiety Order

Exclusion Criteria:

* Women who are pregnant or breast-feeding
* History of severe drug reaction
* History of severe drug withdrawal symptoms such as seizures or delirium
* Disease of cardiovascular system
* Disease of the liver, kidneys, endocrine system, metabolic system or eyes
* History of seizures or seizure disorder
* History of drug or alcohol abuse

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02894320: Dynamic ASPECTS of Internal PRE-ACTIVATION of Effects Sensors of Voluntary ACTION in PARKINSON's Disease
Official title: The Impact of Parkinson's Disease on Internal Preactivation of Sensory Effects of Intention-based Actions. A Subliminal Priming Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson's Disease
Keywords: Parkinson's disease
Voluntary action
Action-effect preactivation
Action-effect prediction
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2016-09-09
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with Parkinson's disease, according to the MDS-UPDRS III (Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale), matched for gender and for age with healthy subjects from a database.

This database has already been constituted by the CNRS (Centre national de la recherche scientifique, Laboratory of Psychology of Perception - UMR8242).

Brief summary: The ability to predict sensory effects of people's own motor actions is a key component of Human action realization. Recent studies revealed this anticipation process to be involved in early and late stages of voluntary actions. Nevertheless, the question whether the action-effect anticipation is impacted or not by "motor pathologies", such as the Parkinson's disease, remains unclear. The current study is aimed to clarify this issue by using a subliminal priming paradigm in patients with Parkinson's disease and in matched control participants. Indeed, subliminal primes corresponding to visual action-effects are displayed at different time points before the actions' execution. Results should allow to determine whether or not the action-effect prediction is impaired at different stages of voluntary action in patients with Parkinson's disease.


Eligibility criteria: Inclusion Criteria:

* Adults age 18 years and older
* Parkinson's disease

Exclusion Criteria:

* Other pathology or neurological or psychiatric history
* Known pregnancy or breastfeeding
* Absence of affiliation to social security or universal health coverage (CMU)
* Person under legal protection
* Patient's opposition to participate

Primary outcomes:
measure: Reaction time
timeFrame: baseline
measure: error rate
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation Ophtalmologique Adolphe de Rothschild
Study officials:
References:
Clinical trial NCT06276920: Evaluation of Joint Position Sense in Healthy Individuals
Official title: Comparison of Elbow Joint Position Sense in Healthy Individuals in Open and Closed Kinetic Positions
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Proprioception
Keywords: Proprioception
Joint Position Sense
healthy individuals
Open Kinetic Position
Closed Kinetic Position
Lead sponsor: Inonu University
Sponsor class: OTHER
First posted: 2024-02-26
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy individuals

Brief summary: It was aimed to measure the elbow joint position sense in healthy individuals in the case of a closed kinetic chain and to compare it with the measurement made in the case of an open kinetic chain.

Detailed description: The study was designed as a non-invasive, cross-sectional study. The population of this research will consist of healthy individuals. Joint position sense will be measured in open kinetic chain and closed kinetic chain via universal goniometer . Each angle position will be repeated 3 times with the elbow in 45, 60, 75 degree flexion angle positions and the average will be calculated. Measurements will be evaluated simultaneously but independently with the 2 different evaluators. Measurements will be repeated after 3 days.

Eligibility criteria: Inclusion Criteria:

* Being between the ages of 18-25
* Being healthy
* Agreeing to participate in the study

Exclusion Criteria:

* Those who have had upper extremity surgery within the last year
* Those with neurological, orthopedic, rheumatic or cardiovascular problems affecting the neck, shoulder, elbow, hand and wrist
* Those with central and peripheral nervous system involvement Having pain anywhere in the body

Primary outcomes:
measure: Joint position sense measurement with universal goniometer in close kinetic chain
timeFrame: 3 days
measure: Joint position sense measurement with universal goniometer in open kinetic chain
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Malatya
country: Turkey
facility: Inonu University
Study officials:
affiliation: Inonu University
name: gulfem ezgi ozaltin, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Inonu University
name: Dilan Demirtaş Karaoba, PhD
role: STUDY_CHAIR
affiliation: Inonu University
name: Havva Adli
role: STUDY_CHAIR
affiliation: Inonu University
name: burcu talu
role: STUDY_CHAIR
References:
Clinical trial NCT01859520: Swim up and Gradient Methods Used in Assisted Reproduction Techniques on DNA Fragmentation of Spermatozoa
Official title: The Effect of Swim up and Gradient Methods Used in Assisted Reproduction Techniques on DNA Fragmentation of Spermatozoa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Male Infertility
Unexplained Infertility
Keywords: Spermatozoa
DNA fragmentation
Swim-up
Density gradient
Lead sponsor: Gazi University
Sponsor class: OTHER
First posted: 2013-05-22
Enrollment: 65
Sex: MALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Sperms are prepared by sperm washing techniques before used in assisted reproductive technologies. Most commonly used sperm preparation methods are the swim up and the density gradient. Recent studies shows that the DNA integrity status of the spermatozoa is related to the success in assisted reproduction techniques. Sperm preparation methods may theoretically cause damage to sperm DNA. Therefore it is important to select the optimum method of sperm preparation causing least sperm DNA damage. Aim of our study is to investigate and compare the effect two different sperm preparation techniques on DNA fragmentation.


Eligibility criteria: Inclusion Criteria:

Male factor subfertile group:

Couples of having at least two abnormal sperm analysis according to WHO criteria.

Unexplained subfertile group:

Couples with normal sperm parameters, plus females with normal ovulatory status and patent fallopian tubes by hysterosalpingography or laparoscopy.

No previous IVF or IUI attempts before the study

Exclusion Criteria:

Severe oligospermia (Sperm count \< 5 Millions/ per ml) Systemic diseases or therapies influencing DNA integrity for male partner

Primary outcomes:
measure: The change in the rate of DNA fragmentation of spermatozoa after sperm preparation with either swim-up or density gradient techniques.
timeFrame: DNA fragmentation assay is performed just before and immediately after the sperm preparation is completed. The time frame is within an hour.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Gazi School of Medicine Department of Obstetrics and Gynecology
name: Ahmet erdem, Professsor, MD
role: STUDY_DIRECTOR
affiliation: University of Gazi School Of Medicine Department of Obstetrics and Gynecology
name: Yuksel Oguz, Resident, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01177020: The Role of Pro-angiogenic Immune Cells in Human Pregnancies
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fetal Growth Retardation
Preeclampsia
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2010-08-06
Enrollment: 300
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Placentas after delivery or abortion

Brief summary: Identification of the presence of proangiogenic immune cells in normal human placentas may enable predication of some pregnancy disorders.


Eligibility criteria: Inclusion Criteria:

* Placentas that have been delivered in the Medical Center

Exclusion Criteria:

* None

Primary outcomes:
measure: To find the angiogenic potential of proangiogenic immune cells derived from human placentas.
timeFrame: Two years
Secondary outcomes:
Other outcomes:
Locations:
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
Study officials:
References:
Clinical trial NCT01342120: PHARMO Institute Seroquel Safety Study
Official title: Seroquel Safety Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Schizophrenia
Major Depressive Disorder
Bipolar Disorder
Generalized Anxiety Disorder
Keywords: atypical antipsychotics
quetiapine
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: PHARMO Institute for Drug Outcomes Research
First posted: 2011-04-27
Enrollment: 18325
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Population based sample of about 2.5 millions residents in the Netherlands

Brief summary: The purpose of this observational study is to study specific outcomes of interest in users of quetiapine compared with all other atypical antipsychotics and specifically olanzapine and risperidone. The outcomes of interest are all-cause mortality, failed suicide attempts, extrapyramidal symptoms, diabetes mellitus, hypothyroidism, acute myocardial infarction and stroke. This retrospective cohort study is based on population-based record linkage system (PHARMO RLS) capturing about 2.5 millions residents in the Netherlands.


Eligibility criteria: Inclusion Criteria:

* Episode of new use of atypical antipsychotics in naïve (not used antipsychotic drugs for a year) users of antipsychotics.

Exclusion Criteria:

* less than a year of recorded history before the cohort entry date
* use of multiple antipsychotics concomitantly
* duration and dose of the antipsychotic drug cannot be determined

Primary outcomes:
measure: The outcomes of interest will be evaluated by means of relative risk based on incidence rates estimates in users of quetiapine vs corresponding incidence rates in users of comparison drugs
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: PHARMO Institute for Drug Outcomes Research
name: Edith Heintjes
role: PRINCIPAL_INVESTIGATOR
References:
citation: Heintjes EM, Overbeek JA, Penning-van Beest FJ, Brobert G, Herings RM. Post authorization safety study comparing quetiapine to risperidone and olanzapine. Hum Psychopharmacol. 2016 Jul;31(4):304-12. doi: 10.1002/hup.2539. Epub 2016 Jun 13.
Clinical trial NCT03006120: Treatment Management and Factors Affecting Mortality in Retroperitoneal Hemorrhage Due to Cardiac Catheterization; Single Center Experience
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Treatment Procedure
Mortality
Lead sponsor: Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2016-12-30
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Retroperitoneal hematoma following cardiac catheterization in our institution between January 2010 and October 2016.

Brief summary: Bleeding complications after cardiac catheterization have been reviewed previously, but there are very few studies on retroperitoneal hematoma and appropriate treatment of patients is not well defined. For this reason, the investigators aimed to analyze the clinical manifestations of retroperitoneal hematomas in a single center using a case-control study design, to analyze the treatment procedure determinants and consequently to provide an updated and usable treatment algorithm.


Eligibility criteria: Inclusion Criteria:

* Retroperitoneal hematoma following cardiac catheterization

Exclusion Criteria:

* Patients with retroperitoneal hematomas other than cardiac catheterization and patients with missing file records.

Primary outcomes:
measure: Mortality
timeFrame: 01/01/2010- 31/10/2016
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: