cyrilzakka/clinical-trials huggingface dataset:
Contrast-Induced Nephropathy After Revision of the Prophylaxis Threshold

After administration of intravascular iodinated contrast media Contrast-Induced Nephropathy (CIN), also known as Contrast-Induced Acute Kidney Injury (CIAKI), may occur. CIN/CI-AKI is associated with increased risk of dialysis and mortality. No treatment exists for CIN/CI-AKI, therefore the focus lies on prevention. Clinical practice guidelines for the prevention of CIN/CI-AKI exist and are implemented in most hospitals. Generally, intravascular volume expansion with normal saline is recommended as prophylaxis.

Earlier this year the results of the AMACING study (A MAastricht Contrast-Induced Nephropathy Guideline study) were published in The Lancet (NL47173.068.14/METC 14-2-006; Clinical Trials.gov NCT02106234; http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(17)30057-0/fulltext). These results show that for the greater part (\>90%) of patients considered to be at risk of CIN/CI-AKI by the guidelines, withholding prophylaxis is non-inferior to giving standard intravenous prophylactic hydration in the prevention of CIN/CI-AKI. Furthermore, the standard prophylactic hydration confers some risk (5.5% complications of intravenous hydration were recorded in the AMACING study).

As a result the clinical protocol in the Maastricht University Medical Centre (MUMC+) has been adapted, and patients with an estimated Glomerular Filtration Rate (eGFR) \>29mL/min/1.73m2 no longer receive intravenous prophylactic hydration before or after procedures with intravascular iodinated contrast material administration.

CINART is a one year prospective observational study with the aim to evaluate the consequences of the protocol change for 1. for incidences of CIN/CI-AKI, dialysis and mortality, 2. for clinical practice in terms of patient burden (complications of prophylaxis), hospital burden (extra hospitalisations for prophylaxis), and costs, as derived from the number of elective procedures carried out in patients formerly eligible for prophylaxis.


Eligibility Criteria:
Inclusion Criteria:

* referred for an elective procedure with intravascular iodinated contrast administration at Maastricht University Medical Centre
* eGFR30-44mL/min/1.73m2 OR eGFR45-59mL/min/1.73m2 + DM OR eGFR45-59mL/min/1.73m2 + \>1 risk factor (\>age \>75 years, anaemia, cardiovascular disease, prescribed NSAID or Diuretic medication) OR multiple myeloma/lymphoplasmacytic lymphoma with small chain proteinuria.

Exclusion Criteria:

* eGFR\<30mL/min/1.73m2
* Dialysis/renal replacement therapy
* emergency procedure
* intensive care patient
Adefovir and Lamivudine for Entecavir Resistance (ALTER Study)

* Entecavir has been one of the option for treatment of lamivudine resistant chronic hepatitis B (CHB).
* In case of entecavir resistance, adefovir could be used. However, sequential monotherapy may result in multidrug resistance.
* It is thought that adefovir and lamivudine combination therapy reduce the risk of adefovir resistance, thereby continued therapy will lead to suppression of hepatitis B virus (HBV) DNA to be undetectable in patients with entecavir resistance.
* This study aim to evaluate the efficacy of adefovir and lamivudine combination therapy in CHB patients with entecavir resistance.

Entecavir is a potent antiviral agent for the treatment of chronic hepatitis B (CHB). However, the incidence of entecavir resistance increases over 50% at 5th year in lamivudine-refractory CHB patients. Considering cross resistance profile, adefovir is a good option for managing entecavir resistance. However adefovir monotherapy may lead to adefovir resistance, because entecavir resistant hepatitis B virus (HBV) retain lamivudine resistance. Previously, combination of adefovir and lamivudine was reported to be effective in a patient with entecavir resistance, but only as a case report form. No further data are available on this combination therapy in a sufficient number of patients. It is thought that adefovir and lamivudine combination therapy reduce the risk of adefovir resistance, thereby continued combination treatment will result in suppression of HBV DNA to be undetectable in patients with entecavir resistance.

The aim of this study is to evaluate the efficacy of adefovir and lamivudine combination therapy in CHB patients with entecavir resistance.

Eligibility Criteria:
Inclusion Criteria:

1. Chronic hepatitis B patients (positive HBsAg \> 6 months)
2. Age \> 18 year old
3. History of treatment with entecavir more than 6 months
4. Proven entecavir resistant mutation (rtT184S/A/I/L/G/C/M, rtS202G/C/I, or rtM250I/V)
5. HBV DNA level\> 2000 IU/mL
6. Compensated liver disease (Child-Pugh-Turcotte score over 7; prothrombin time prolonged more than 3 sec above ULN or INR over 1.5; serum albumin \>3 g/dL; total bilirubin \<2.5 mg/dL; No history of variceal bleeding, ascites, or hepatic encephalopathy)
7. Patients willing to give informed consent

Exclusion Criteria:

1. Out of inclusion criteria
2. Any one of following

   * Serum phosphorus level under 2.4 mg/dL
   * Serum creatinine level over 1.5 mg/dL or creatinine clearance \<50 mL/min
   * Absolute neutrophil count lower than 1000 cell/mL
   * Hb level under 10 g/dL (male), under 9 g/dL (female)
   * Serum AFP \>100 ng/mL
3. History of treatment with interferon-alfa, thymosin-alfa 1, or nucleos(t)ide analogue other than entecavir in 6 months of screening
4. History of adefovir resistance (detection of rtA181T/Vor rtN236T at screening or in the past)
5. Recipient of organ transplantation
6. Positive antibody test to HIV, HCV or HDV
7. Pregnant or breast feeding women
8. Patients with hepatocellular carcinoma or uncontrolled malignant disease
9. Habitual alcohol drinker (\>140 g/week for men, \>70 g/week for women) -
Sarpogrelate-Aspirin Comparative Clinical Study for Efficacy and Safety in Secondary Prevention of Cerebral Infarction (S-ACCESS)

Sarpogrelate (MCI-9042) is an antiplatelet drug that decreases 5-hydroxytryptamine (5-HT) levels in platelets via a blockade of 5-HT2 receptors; it has been used in atherosclerotic peripheral arterial disease.

S-ACCESS was a randomized, double-blinded trial to compare the relative efficacy of sarpogrelate (100mg three times daily) and aspirin (81mg once daily) in 1510 patients with recent cerebral infarction. Patients were followed for 0.9 to 3.5 years. The primary endpoint was recurrence of cerebral infarction; relative safety was also assessed.


Eligibility Criteria:
Inclusion Criteria:

* Cerebral infarction except cardiac source of embolism
* Onset ≧ 1 week to ≦ 6 months before randomization
* Neurological signs persisting ≧ 1 day from onset
* Computed tomography (CT) or magnetic resonance imaging (MRI) detection of responsible site
* Age ≧ 20 years
* Systolic pressure ≦ 180 mmHg; diastolic pressure ≦ 110 mmHg

Exclusion Criteria:

* Functional outcome at randomization: Modified Rankin Scale = 4, 5
* Previous or planned vascular surgery for cerebral infarction
* History of intracranial hemorrhage
* History of systemic bleeding, or other history of bleeding diathesis or coagulopathy
* Severe complications (renal or hepatic insufficiency, heart failure, hemopathy, etc.)
* Pregnant or possibly pregnant women, or nursing mothers
* History of sarpogrelate and aspirin sensitivity
* Treating malignant tumor or treated within 5 years
* Current peptic ulceration
REvascularization CHoices Among Under-Represented Groups Evaluation: The RECHARGE Trial - Women

This is a research study in women to compare the outcomes of two procedures that restore blood flow to the arteries of the heart. In one procedure the blockages are ballooned and then stented with a small wire mesh tube through a small incision in the wrist or the groin. The other procedure is an open-heart operation in which healthy blood vessels from inside the chest, leg, and/or forearm are used to "bypass" the blockages (like a detour). Outcomes will be measured by comparing survival and improvement in quality-of-life.

The RECHARGE: Women Trial is a multicenter, 1:1 randomized, open-label superiority trial.

Patients meeting the eligibility criteria for whom there is equipoise for revascularization with CABG and PCI, as determined by the local Heart Team, will be included. Participants will be followed for 5-10 years. Telephone follow-up will be conducted by the a central follow-up coordinating center at 30 days, 3 months, 6 months, and thereafter every 6 months through 36 months post-randomization. After 36 months, follow-up will be performed every year (48, 60, 72, 84, 96, 108, 120 months). A repeat transthoracic echocardiogram and blood draw for serum creatinine, hemoglobin and lipids should be performed at 1 year, as per standard of care, at either an out-patient facility or in a hospital.

Eligibility Criteria:
Inclusion Criteria:

1. Female sex
2. Patient is at least 18 years old.
3. Multivessel or left main CAD is present for which revascularization is intended and for which there is equipoise between CABG and PCI according to local Heart Team assessment.
4. Ability to provide written informed consent and comply with all follow-up procedures, including QOL questionnaires.

Exclusion Criteria:

1. ST-segment elevation MI within 3 days
2. Cardiogenic shock
3. Prior PCI within 1 year or any prior CABG anytime
4. Planned hybrid revascularization (PCI after CABG or CABG after PCI)
5. Planned single vessel revascularization (other than isolated left main disease)
6. Need for any cardiac surgical or interventional procedure other than coronary revascularization at the present time or anticipated within 3 years
7. Pregnancy (women of child-bearing potential must have a negative pregnancy test within 1 week before randomization) or intent to become pregnant within 1 year after randomization
8. Unable to tolerate, obtain or comply with dual antiplatelet therapy for at least 3 months if presentation with stable CAD or 6 months if presentation with a troponin-positive acute coronary syndrome
9. Current participation in another investigational drug or device study that has not reached its primary endpoint
10. Life-expectancy less than 3 years due to concomitant non-cardiac conditions
11. Any condition(s) are present that are likely to interfere with the study protocol procedures including medication adherence and follow-up through 10 years (e.g. mental disability, substance abuse, anticipated international relocation, etc.)
A Study of mRNA-1608, a Herpes Simplex Virus -2 (HSV-2) Therapeutic Candidate Vaccine, in Healthy Adults 18 to 55 Years of Age With Recurrent HSV-2 Genital Herpes

The purpose of this study is to generate safety and immunogenicity data and establish a proof-of-concept of clinical benefit of the mRNA-1608 vaccine candidate.

Participants with a history of recurrent genital herpes will be randomly assigned in a 1:1:1:1 ratio to receive mRNA-1608 at 1 of the 3 dose levels or control (BEXSERO) administered as 2 doses at 0 and 2 months (Day 1 and Day 57).

Eligibility Criteria:
Inclusion Criteria:

* Participant has a diagnosis of genital HSV-2 infection for at least 1 year before the Screening Visit.
* Seropositive for HSV-2 as determined by Western Blot.
* Participant has a history of recurrent genital herpes defined as at least 3 and no more than 9 reported genital herpes recurrences in the 12 months preceding the Screening Visit, or if currently on suppressive therapy, prior to initiation of suppressive therapy.
* Willing to refrain from taking suppressive antiviral therapy from the Screening Visit until the end of the study.
* Willing to refrain from the use of episodic antiviral therapy during the three 28-day anogenital swabbing periods. Episodic therapy may be used outside the three 28-day swabbing periods.
* For female participants of childbearing potential: negative pregnancy test, adequate contraception, and not currently breastfeeding.

Exclusion Criteria:

* Prior immunization with a vaccine containing HSV antigens.
* History of any form of ocular HSV infection, HSV-related erythema multiforme, or HSV-related neurological complications.
* History of genital HSV-1 infection.
* History of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) types 1 or 2 (HIV-1, HIV-2).
* Reported history of anaphylaxis or severe hypersensitivity reaction after receipt of any mRNA vaccine(s) or any components of the mRNA vaccines.
* Previously received BEXSERO or other vaccine to prevent serogroup B meningococcal disease (also known as meningitis B).
* History of allergic disease or reactions likely to be exacerbated by any component of BEXSERO vaccine.
* Has received or plans to receive any licensed or authorized vaccine, including COVID-19 vaccines, ≤ 28 days prior to the first study injection (Day 1), or plans to receive a licensed or authorized vaccine within 28 days before or after study injection with the exception of licensed influenza vaccines, which may be received more than 14 days before or after any study injection.

Note: Other inclusion and exclusion criteria may apply.
Atorvastatin Versus Ezetimibe and Fenofibrate as a Lipid-lowering Strategy

The primary aim of this study is to evaluate the efficacy and non-inferiority of a lipid-lowering medication regimen comprised of the medications ezetimibe and fenofibrate taken daily, versus atorvastatin daily in lowering levels of low-density lipoprotein (LDL-C) cholesterol. Additionally, other aims would include effects on other types of blood cholesterol and examining the safety of the ezetimibe and fenofibrate regimen, as compared to atorvastatin.

It has been demonstrated in several previous primary and secondary studies that lowering low-density lipoprotein cholesterol (LDL-C) with the use of medications such as 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors improves mortality and morbidity related to cardiovascular events in patients with hypercholesterolemia. Such inhibitors, which are known as 'statins', act to block the synthesis of cholesterol in the liver. These medications are generally well tolerated by the vast majority of patients, but a small number experience side effects, most seriously those of myopathies, rhabdomyolysis and elevated liver enzymes - recognition of this fact, that statins are not universally without problems, highlights the need for viable alternatives.

Ezetimibe is a relatively new medication in Canada, approved for use in patients with cholesterol problems. It is an intestinal cholesterol binder that is known to be well-tolerated, with side effects similar to placebo. Alone, it has a modest effect in the lowering of LDL-C. Fenofibrate is a medication that also works through the liver and has long been used to adjust blood lipid levels in patients with mixed lipid problems. Alone it also has a modest effect in the lowering of LDL-C. Recent study, however, has shown that the effect of ezetimibe and fenofibrate together in the lowering of LDL-C is greater than that of either drug alone. This combination, if as effective in this regard as atorvastatin, would prove a valid alternative to the use of the atorvastatin in the lowering of LDL-C, and a benefit for patients who have had problems tolerating statin therapy but still require medication for elevated cholesterol.

Eligibility Criteria:
Inclusion Criteria:

-Study is confined to subjects with elevated LDL-C levels 3.0 mmol/L and greater.

Exclusion Criteria:

* Abnormal liver enzymes (ie, AST, ALT greater than three times the upper limit of normal);
* Creatine kinase levels more than two times the upper limit of normal;
* Uncontrolled ethanol use (this may affect compliance);
* Pregnant or breastfeeding women or women not using adequate contraceptive methods;
* Previous history of intolerance or adverse effects with statins;
* Previous history of intolerance or adverse effects with fibric acid derivatives;
* Previous history of intolerance or adverse effects with ezetimibe;
* Uncontrolled diabetes (HbA1c \> 10%);
* Recent myocardial infarction (within 6 weeks);
* Concurrent enrollment in another study.
Video Tool to Promote Knowledge of Syphilis as Facilitator of HIV Transmission

During the winter of 2007, the Syphilis Advisory Group and Bureau of STD Control of the NYC Department of Health funded the Emergency Department of Jacobi Medical Center to further evaluate the effectiveness of the Syphilis and Men video in additional settings where men access STD related information and testing and where high-risk groups, such as MSM, frequent. The video was evaluated for promoting knowledge of syphilis, especially as facilitator of HIV transmission, and in encouraging concurrent testing (syphilis and HIV) among men recruited from a community-based organization, an ambulatory care setting, and a dance club.

The Solomon-four group design was applied to assess the effectiveness of the video in raising syphilis knowledge among participants, while controlling for the influence of the pre-test knowledge survey in skewing post-knowledge survey scores. Participants in Group 1 received a pre-test survey, the video intervention, and the post-test survey; Group 2 received the pre-test and post-test surveys; Group 3 received the video intervention and post-test survey; and Group 4 received the post-test survey only. A computer-generated randomization list was used to assign participants to one of the four groups.

Eligibility Criteria:
Inclusion Criteria:

* must speak english or spanish

Exclusion Criteria:

* excluded if hearing or visually impaired
A Study to Evaluate the Efficacy and Safety of DR-103 for the Prevention of Pregnancy

This is an open-label, single-treatment study. All subjects will receive 12 months of oral contraceptive therapy with DR-103. Study participants will receive physical and gynecological exams, including Pap smear. During the study, all participants will be required to complete a diary.


Eligibility Criteria:
Inclusion Criteria:

* Sexually active at risk for pregnancy
* Agreement to use study OC therapy as their only method of birth control during the study
* history of regular spontaneous menstrual cycles or withdrawal bleeding episodes
* Others as dictated by FDA-approved protocol

Exclusion Criteria:

* Any contraindication to the use of oral contraceptives
* Pregnancy or plans to become pregnant in the next 14 months
* Smoker and age ≥ 35 years
* Others as dictated by FDA-approved protocol
A Study to Assess the Bioequivalence Between Brivaracetam Tablet and Dry Syrup in Healthy Male Japanese Study Participants

The purpose of the study is to demonstrate the bioequivalence between the BRV tablet and BRV as dry syrup after a single oral dose in healthy Japanese male study participants.


Eligibility Criteria:
Inclusion criteria:

* Study participant must be between 20 to 50 years of age (inclusive) at the time of signing the Informed Consent Form (ICF)
* Study participant is overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring
* Study participant is of Japanese descent as evidenced by appearance and verbal confirmation of familial heritage (a study participant has all 4 Japanese grandparents born in Japan)

Exclusion criteria:

* Study participant has used other drugs, including over-the-counter medications, herbal/traditional medicines, or dietary supplements (excluding medicines for external use),with the exception of paracetamol, within 14 days before first administration of IMP or has received a coronavirus disease 2019 (COVID-19) vaccine within 7 days of initiating IMP
* Study participant has used hepatic enzyme-inducing drugs (eg, glucocorticoids, phenobarbital, isoniazid, phenytoin, rifampicin) within 2 months before the first administration of Investigational Medicinal Product (IMP)
* Study participant has a positive result for hepatitis B surface antigen, hepatitis C virus antibody test, human immunodeficiency virus antibody test, or syphilis at Screening Visit
* Study participant has donated blood or plasma or has experienced blood loss ≥400 mL within 90 days, ≥200 mL within 30 days, or has donated any blood or plasma within 14 days before first administration of IMP
* Study participant is a current smoker or has used nicotine-containing products (eg, tobacco, patches, gum) within 30 days before the first administration of IMP
* Consumption of more than 600 mg of caffeine/day (1 cup of coffee contains approximately 100mg of caffeine, 1 cup of tea approximately 30 mg, and 1 glass of cola approximately 20 mg)
A Novel Motivational Ecological Momentary Intervention for Anorexia Nervosa

The aim of this study is to pilot an innovative motivational text-message intervention for individuals with anorexia nervosa and subthreshold anorexia nervosa. Patients will receive personalized motivational text-messages as an adjunct to cognitive behavioral therapy (CBT). CBT will be provided to patients at no cost for the duration of the study. The investigators hypothesize that the text-messages will help increase motivation to change and kilocalorie intake and decrease eating disordered behavior.


Eligibility Criteria:
Inclusion Criteria:

* Anorexia nervosa/subthreshold anorexia nervosa (i.e., individuals who exhibit significant dietary restraint)
* 18+ years old

Exclusion Criteria:

* BMI \< 16.5
* Medication instability for 6 weeks
* Recent/current suicidal risk
* Comorbid substance abuse or dependence, bipolar disorder, schizophrenia, or mental retardation
* Inability to provide release of information to a medical provider
Cardiac Output Monitoring by ccNexfin© in Pregnant Women

Variations of cardiac output are frequent in pregnant women during obstetrical procedures, and may participate to poor foetal outcomes through decrease of uteroplacental bloodflow. Thus, monitoring maternal cardiac output appears of major interest, as it would open the way to early initiation of hemodynamic supportive management.

The ccNexfin© is a non-invasive hemodynamic monitoring device, whose relevance for continuous monitoring of cardiac output has been reported in a non-pregnant population.

The hypothesis is that ccNexfin© gives acceptable measurement of maternal cardiac output in pregnant women.


Eligibility Criteria:
Inclusion Criteria

* Pregnancy \> 32 weeks of amenorrhea
* Informed consent to participate to the study
* Health insurance

Exclusion Criteria:

* Poor echogenicity for Transthoracic echocardiography
* Cardiopathy
* Difficulties to move
* Necessity of strict supine or lateral position
* Impossibility to receive information or to give inform consent to participate to the study Refusal to sign inform consent