louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03123575: Polypharmacy and Clinically Significant Drug Interactions Among HIV-Infected Patients Receiving Antiretroviral Therapy
Official title: Polypharmacy and Clinically Significant Drug Interactions Among HIV-Infected Patients Receiving Antiretroviral Therapy in The Region Of Madrid: A Population-Based, Cross-Sectional Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: HIV
Lead sponsor: Hospital General Universitario Gregorio Marañon
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dohme LLC
name: SERMAS
name: Molecular-Clinical Pharmacol/Instit.Translational Medicine/University Liverpool
First posted: 2017-04-21
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ART-treated patients who picked up ARVs and of all HIV-uninfected individuals who picked up Co-meds in the study period.

Brief summary: This will be a cross-sectional population-based study carried out in the region of Madrid (6,468,322 inhabitants according to current census) to quantify the number of Co-meds in HIV-infected individuals on ART in the region of Madrid, categorized by age and gender, and to compare the number of Co-meds between the ART-treated population and HIV-uninfected population in the region of Madrid, categorized by age and gender.

Detailed description: This will be a cross-sectional population-based study carried out in the region of Madrid (6,468,322 inhabitants according to current census) to quantify the number of Co-meds in HIV-infected individuals on ART in the region of Madrid, categorized by age and gender, and to compare the number of Co-meds between the ART-treated population and HIV-uninfected population in the region of Madrid, categorized by age and gender.

Eligibility criteria: Inclusion Criteria:

* patients who picked-up Co-meds in the study period

Exclusion Criteria:

* NONE

Primary outcomes:
measure: the number of Co-meds in HIV-infected individuals on ART
timeFrame: 6 months
measure: number of Co-meds between the ART-treated population and HIV-uninfected
timeFrame: 6 months
measure: prevalence of potential CSDIs between ARVs and Co-meds in ART-treated individuals
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00764075: Guided Placement of CRT-Leads
Official title: CT and 3D-Echocardiography Placement of CRT-Leads
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: heart failure; EF<35%; NYHA II, III or IV
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
Collaborators: name: University of Chicago
First posted: 2008-10-01
Enrollment: 132
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: In this open, prospective, randomized, parallel group, German-American, two-center, Phase I study the standard-approach CRT-implantation will be compared to a guided CRT-implantation after determining the site of latest contraction and placement of the electrode as close as possible to this site, using a 5-step-scheme of imaging methods determining the site of latest contraction prior to implantation.

Detailed description: Patients will be allocated to two groups with either

1. Guided implantation of the left ventricular lead
2. Empirical implantation of the left ventricular lead (current clinical standard)

For Treatment Group a) the target vessel, which is the vessel with smallest distance between RLC and CVS is determined in advance and provided to the implanting physician. In case, this vessel is not amenable for lead positioning, a second vessel which is the second closest to the RLC is defined.

For Treatment Group b), the physician has to choose the vessel where to place the electrode without knowing the exact spatial orientation between that particular side-branch and the RLC.

In all patients, standard biventricular devices and leads are to be used. Aspects that are evaluated are:

1. Technical success in placing the electrode in the target vessel.
2. Failure due to dislocation during the implantation procedure or phrenic nerve stimulation.

Also, procedure duration, radiation exposure, and complications occurring during the procedure as well as post- operatively will be documented.

Eligibility criteria: Inclusion Criteria:

* Congestive heart failure,
* Ejection fraction \<35%,
* Complete left bundle branch block \>120ms,
* NYHA II,III or IV

Exclusion Criteria:

* Patients not fulfilling the inclusion criteria or not capable/mental able to understand and follow the instructions;
* Impaired kidney function (GFR \<30ml/min;
* Pregnant or breastfeeding women

Primary outcomes:
measure: Rate of non-responders regarding ejection fraction
timeFrame: 6 months
Secondary outcomes:
measure: rate of non-responders regarding NYHA-classification, left end-diastolic and end-systolic volume
timeFrame: 6 months
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Department of Medicine, Division of Cardiology, Pulmonology and Vascular Medicine
state: NRW
Study officials:
affiliation: RWTH Aachen University Departement of Cardiology, Pulmonology and Vascular Medicine
name: Christian Knackstedt, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03916575: PEComas: Natural History and Prognostic Factors
Official title: National Multicenter Retrospective Study: PEComas: Natural History and Prognostic
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: PEComas
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2019-04-16
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient having PEComas diagnosed in France between 1990 and 2018

Brief summary: Perivascular epithelioid cell tumors are rare and characterized by the expression of myomelanocytic markers. They belong to a complex tumor family that includes angiomyolipomas, lymphangioleiomyomatosis and other soft-tissue tumors. Given their rarity, the natural history of pecomas is not yet understood, and a comprehensive classification that integrates clinical, pathological and molecular features has not been achieved as of today.

This study is a national multicenter retrospective study to better understand the natural history of PEComas, excluding lymphangioleiomyomatosis and classic triphasic angiomyolipomas.

The primary purpose is the identification of prognostic markers impacting the relapse. Secondaries purposes are to identify prognostic markers impacting the overall survival and to have a better understanding of natural history


Eligibility criteria: Inclusion Criteria:

* Major patient (≥18 years old)
* Minor patient (1 to 17 years old)
* PEComas diagnosed in France between 1990 and 2018 and read back by a pathologist referent of sarcomas
* Patient having agreed to the use of his medical data for the purpose of this research.
* Parental authorities having given their agreement for the reuse of their child's medical data for the purpose of this research.

Exclusion Criteria:

* Opposition of the patient (or his legal representative) to the reuse of his data for the purposes of this research
* Impossibility of giving the subject clear information
* Patient under safeguard of justice
* Patient under guardianship
* Lymphangioleiomyomatosis
* Classic triphasic angiomyolipoma

Primary outcomes:
measure: Study of the prognostic factors associated with the risk of relapse
timeFrame: The period from January 1st, 1990 to December 31, 2018 will be examined
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service D'Hematologie Et D'Oncologie
Study officials:
References:
Clinical trial NCT00623675: Heavy Metal Urine Analysis in 20 Healthy Persons Taking Mineralox
Official title: Heavy Metal Urine Analysis in 20 Healthy Persons Taking Mineralox
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: PHASE4
Conditions: Healthy
Keywords: zeolites
nutraceuticals
natural supplements
Healthy volunteers
Lead sponsor: CreoMed, Inc.
Sponsor class: INDUSTRY
First posted: 2008-02-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Researchers want to find out if urine heavy metal levels are changed in persons who use Mineralox Basic C™ (Mineralox). Mineralox is a zeolite (clinoptilolite) in combination with Vitamin C. Zeolites are natural supplements (nutraceuticals) that work at the cellular level to remove heavy metals and toxins that are accumulated in every day life safely from the body through the urine. The study doctor will give Mineralox to 20 people in this study to see if it helps with the heavy metal removal from the body.


Eligibility criteria: Inclusion Criteria:

1. Females and Males age 18-75 without significant health problems as determined by the Principal Investigator.
2. Nonsmoker
3. Ability to understand informed consent

Exclusion Criteria:

1. Pregnancy
2. Any serious or unstable disease within 6 months; seizure risk; diabetes mellitus requiring insulin or oral hypoglycemic medication; diagnosis of eating disorder, use of MAOI in the prior 14 days; hepatic or renal impairment; clinically significant cardiovascular disease within 6 months; uncontrolled hypertension; severe chronic obstructive pulmonary disease; baseline systolic blood pressure higher than150mm Hg or diastolic blood pressure higher than 95 mm Hg; history of cancer (except treated basal cell or squamous cell carcinoma of the skin); history of clinically significant allergic reactions or laboratory abnormalities,and patients taking AREDS Eye Vitamins.
3. Major depressive disorder within the past year requiring treatment; history of panic disorder, psychosis, bipolar disorder, or eating disorder
4. Intention to donate blood or blood products during treatment phase of the study;
5. Alcohol or drug abuse/dependency within the past year
6. Use of tobacco products other than cigarettes or use of marijuana
7. Body mass index (calculated as weight in kilograms divided by the square height in meters) less than 15 or greater than 38 or weight less than 45.5 kg
8. NRT, antidepressants, antipsychotics, mood stabilizers/anticonvulsants, naltrexone, steroids or insulin.

Primary outcomes:
measure: Heavy Metal Urine Analysis
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Naples
country: United States
facility: NEMA Research
state: Florida
Study officials:
affiliation: NEMA Research, Inc.
name: Joseph V Pergolizzi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02014675: SD01 Registry (SD01 ICD Lead)
Official title: SD01 Registry (SD01 ICD Lead)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventricular Fibrillation
Ventricular Tachycardia
Heart Failure
Keywords: ICD
CRT-D
Lead
Lead sponsor: Biotronik SE & Co. KG
Sponsor class: INDUSTRY
First posted: 2013-12-18
Enrollment: 280
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 standard ICD/CRT-D (cardiac resynchronization therapy plus defibrillator) indication

Brief summary: This registry is designed to gather further evidence, in addition to the SD01 Master Study, for the safety and efficacy of the SD01 ICD lead.


Eligibility criteria: Inclusion Criteria:

* Meet a standard indication for ICD/CRT-D therapy
* First ICD/CRT-D implantation or upgrade from pacemaker
* Signed informed consent form
* Willing to participate for the whole duration of the registry
* Patient accepts Home Monitoring concept and is able to activate and use the Cardiomessenger
* Patient has legal capacity and ability to consent

Exclusion Criteria:

* Meet a standard contraindication for an ICD/CRT-D therapy
* Age \<18 years
* Pregnant or breast-feeding women
* Cardiac surgery planned within the next six months
* Enrollment in another cardiac clinical investigation with active treatment arm
* Mechanical tricuspid valve prosthesis or severe tricuspid valve disease
* Dexamethasone acetate intolerance

Primary outcomes:
measure: SADE-free rate
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
measure: Pacing threshold of SD01
timeFrame: 3-month follow-up
measure: Sensing amplitude of SD01
timeFrame: 3-month follow-up
measure: Device deficiencies
timeFrame: 10 years
measure: Long-term pacing impedance, pacing threshold, sensing amplitude and painless shock impedance of SD01 and other leads, if applicable
timeFrame: 10 years
measure: Analysis of arrhythmias and their treatment
timeFrame: until 3-month follow-up
measure: ICD/CRT-D system performance
timeFrame: 10 years
measure: SD01 implantation information, handling and operation time record
timeFrame: Implantation
Locations:
city: Berlin
country: Germany
facility: DRK Klinikum Berlin-Köpenick
city: Berlin
country: Germany
facility: Vivantes Humboldt Klinikum Berlin
city: Hamburg
country: Germany
facility: Universitäres Herzzentrum Hamburg
city: Leverkusen
country: Germany
facility: Klinikum Leverkusen
city: Lübeck
country: Germany
facility: University Clinic of Schleswig-Holstein
city: Merseburg
country: Germany
facility: Carl-von-Basedow Klinik
city: Papenburg
country: Germany
facility: Marienkrankenhaus Papenburg
city: Ratzeburg
country: Germany
facility: DRK Krankenhaus Moelln-Ratzeburg
city: Suhl
country: Germany
facility: SRH Zentralklinikum Suhl
city: Würzburg
country: Germany
facility: Universitätsklinik Würzburg
Study officials:
References:
Clinical trial NCT05532475: Vitreous Level Of Tumor Necrosis Factor Alpha In Patients With Retinal Vein Occlusion
Official title: Vitreous Level Of Tumor Necrosis Factor Alpha In Patients With Retinal Vein Occlusion
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Retinal Vein Occlusion
Keywords: Tumor necrosis factor alpha
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2022-09-08
Enrollment: 40
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: PROBABILITY_SAMPLE
Study population: Retinal venous occlusion patients admitted in KasrAlainy Hospital for Intravitreal Injection of Lucentis (Cases) compared to patient without retinal vein occlusion admitted for cataract surgery (Controls).

Brief summary: To assess the levels of TNF- α in vitreous samples of patients with retinal vein occlusion prior to administration of intravitreal anti-VEGF and compare them to levels in vitreous samples of normal subjects so as to investigate the association of vitreous tumor necrosis factor with the pathogenesis of retinal vein occlusion.


Eligibility criteria: Inclusion Criteria:

* Any patient with retinal vein occlusion not older than 6 months with no history of Anti-VEGF injection

Exclusion Criteria:

1. Diabetic patients.
2. Other causes of retinal vascular diseases.
3. Patients with history of treatment of retinal vein occlusion.
4. Previous intraocular surgery except cataract surgery performed 6 months before the study.
5. Subjects with severe systemic inflammatory diseases
6. Retinal vein occlusion secondary to retinal vasculitis.
7. All retinal pathologies.
8. Patients receiving Systemic steroids or Immunosuppressive therapy.

Primary outcomes:
measure: to assess vitreous level of tumor necrosis factor alpha in retinal vein occlusion and compare it to patient undergoing cataract surgery
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr ALainy University hospital
Study officials:
References:
Clinical trial NCT03326375: Comparison of SBRTand Repeat TACE for HCC
Official title: Comparison of Stereotactic Body Radiation Therapy (SBRT)and Repeat Transarterial Chemoembolization (TACE) for Hepatocellular Carcinoma (HCC) as a Local Salvage Treatment After Incomplete TACE : A Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: HepatoCellular Carcinoma
Keywords: TACE
SBRT
Lead sponsor: Gangneung Asan Hospital
Sponsor class: OTHER
Collaborators: name: Soonchunhyang University Hospital
First posted: 2017-10-31
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparison of Stereotactic Body Radiation Therapy (SBRT) and repeated transarterial chemoembolization (TACE) for Hepatocellular Carcinoma (HCC)as a Local Salvage Treatment after first incomplete TACE

Detailed description: The aim of this study is to evaluate the effect of SBRT after first incomplete TACE.

In HCC patients with incomplete TACE response, repeated TACE did not showed good response. In this case, SBRT could have better results than TACE.

Eligibility criteria: Inclusion Criteria:

* Age \>18 years
* Eastern cooperative oncology group(ECOG) score 0 to 2
* Primary HCC
* HCC (single nodule ≤ 7 cm or max 3 nodules ≤ 3 cm)
* Child-Turgottei-Pugh A or B
* Unresectable lesion or medically contraindicated surgery or a case in which surgery was declined.
* No evidence of radiologically definable major vascular invasion or extrahepatic disease
* Previously incomplete TACE with radiologically defined residual disease after first TACE
* Informed consent

Exclusion Criteria:

* Prior TACE to the target lesion
* Contraindication to receiving radiotherapy or TACE
* Decompensated liver cirrhosis
* Extrahepatic mets
* Pregnancy
* Patients with other cancers

Primary outcomes:
measure: Local tumor control (efficacy fo SBRT)
timeFrame: 1 year
Secondary outcomes:
measure: progression free-survival
timeFrame: 2 year
measure: overall survival
timeFrame: 2 year
measure: Radiation induced liver disease (RILD)
timeFrame: 1 year
Other outcomes:
Locations:
city: Wŏnju
country: Korea, Republic of
facility: Gangneung Asan Hospital
state: Gangwondo
Study officials:
affiliation: University of Ulsan College of Medicine, Gangneung Asan Hospital
name: Gab Jin Cheon, M.D, Ph. D
role: STUDY_DIRECTOR
References:
Clinical trial NCT03234075: Evaluation of a New Regional Organization to Promote Access to Renal Transplantation
Official title: Promoting Access to Renal Transplantation: Impact of a Patient-centered Regional Organization
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Renal Failure
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2017-07-31
Enrollment: 4000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population participating in the study is composed of patients with a terminal Chronic Kidney Disease (CRD) requiring renal function supplementation.

Brief summary: Patients with terminal chronic kidney disease (CRD) need renal function supplementation, namely dialysis or renal transplantation. Transplantation is the most efficient and cost-effective treatment. Early and equitable access to transplantation is a public health issue. Access to transplantation is facilitated by early and systematic information and assessment of patients for inclusion in the national waiting list for transplantation prior to the onset of dialysis, and by the development of transplantation from living donors. In France, there are wide disparities in access to national waiting list registration and transplantation. One of the causes of these inequalities in access would be the disparity in referral practices to a transplant medical and surgical team authorized to register the individual on the national waiting list.

The aim of the TRACE study is to evaluate the impact of a new regional organization promoting renal transplantation on access to renal transplantation.


Eligibility criteria: Inclusion Criteria:

* Patient older than 18 years and younger than 85 years.
* Entered in the French Network Epidemiology and Information in Nephrology register
* Renal function supplementation begun in 2013 -- 2014 (period before regional organization implementation) or in 2018 -- 2019 (period after regional organization implementation).

Exclusion Criteria:

- Patient followed in a Center of nephrology-dialysis or of Renal transplantation located outside French Auvergne Rhône Alpes or Center Regions.

Primary outcomes:
measure: Cumulative incidence rate of access to renal transplantation for patients with end-stage renal failure
timeFrame: At 24 months after initiation of renal function supplementation
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Service de Transplantation, Groupement Hospitalier Edouard Herriot, Hospices Civils de Lyon
Study officials:
References:
Clinical trial NCT00627575: AED/Statin Interaction Study
Official title: An Open-label, Two-cohort Study to Assess the Effect of Lamotrigine and Phenytoin on the Pharmacokinetics of Atorvastatin in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Epilepsy
Keywords: drug interaction
pharmacokinetics
healthy volunteers
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2008-03-03
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will evaluate the amount of the cholesterol-lowering drug atorvastatin available in the bloodstream, when taken together with the anti-seizure drugs lamotrigine or phenytoin.


Eligibility criteria: Key Inclusion Criteria:

* Body weight \>50kg (men) or \>45kg (women) and BMI within the range 19-32 kg/m2 inclusive.
* No clinically significant abnormality on clinical examination

Key Exclusion Criteria:

* History or evidence of drug or alcohol abuse or active tobacco use.
* Women of childbearing potential
* Use of prescribed or non-prescribed medications during and within 14 days of starting study medication.

Primary outcomes:
measure: Steady-state Cmax and AUC (0-t) of atorvastatin
timeFrame: Pre-dose,0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 20 and 24 hrs post dose.
Secondary outcomes:
measure: To assess the effect of lamotrigine or phenytoin on the pharmacokinetics of 2-OH atorvastatin and 4-OH atorvastatin
timeFrame: Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 20 and 24 hrs post dose.
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: GSK Investigational Site
state: New York
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Bullman J, Nicholls A, Van Landingham K, Fleck R, Vuong A, Miller J, Alexander S, Messenheimer J. Effects of lamotrigine and phenytoin on the pharmacokinetics of atorvastatin in healthy volunteers. Epilepsia. 2011 Jul;52(7):1351-8. doi: 10.1111/j.1528-1167.2011.03118.x. Epub 2011 Jun 2.