cyrilzakka/clinical-trials huggingface dataset:
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ACZ885 in Healthy Japanese Male Volunteers

This study will evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of ACZ885 administered via intravenous infusion and subcutaneous injection in healthy Japanese male volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Japanese healthy male subjects age 20 to 45 years of age, and in good health
* At screening and baseline, the subjects must be in good health as determined by past medical history, physical examination, electrocardiogram, laboratory tests and urinalysis.
* Body mass index within the range of 18 to 28 kg/m2 and weigh 50 to 100 kg

Exclusion Criteria:

* Smokers.
* Use of any prescription drugs within 4 weeks prior dosing, or over-the-counter medication (vitamins, herbal supplements, dietary supplements) within 2 weeks prior to dosing. Acetaminophen is acceptable. Treatment of any biologics within three months prior to dosing. Having live vaccinations within six months prior to dosing.
* Participation in any clinical investigation within 4 months prior to dosing.
* Donation or loss of 400 mL or more of blood within 3 months; donation or loss of 200 mL or more of blood within 1 month; or donation of component blood within 2 weeks prior to participation.
* Significant illness (sinusitis, pneumonia, cystitis, sepsis, etc) within two weeks prior to dosing.
* A past personal or close family medical history of cardiac disorders
* History of:

  * fainting,
  * low blood pressure when standing,
  * abnormal heart rhythms
  * acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease, treated or not treated).
* Clinically significant drug allergy or history and complication of atopic allergy (asthma, urticaria, eczematous dermatitis)
* Known hypersensitivity to the study drug or similar drugs
* Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs or jeopardize participation in the study.
* History of immunodeficiency diseases, including a positive HIV test result.
* A positive Hepatitis B surface antigen (HBsAg), Hepatitis C or Syphilis test result.
* Drug or alcohol abuse within the 12 months prior to dosing
* Tuberculosis symptoms, complication of tuberculosis, contact with patients with suspected tuberculosis symptoms

Other protocol-defined inclusion/exclusion criteria may apply
Impact of Admission SOFA Score and 48-hour Delta SOFA on Clinical Outcomes in Critically Ill Patients

Organ dysfunctions are associated with high morbidity and mortality. The SOFA (Sequential Organ Failure Assessment) score developed by Vincent et al. sequentially assesses the presence and severity of dysfunctions in six organ systems: respiratory, cardiovascular, coagulation, hepatic, neurological and renal. Although the SOFA score was created to quantify organ dysfunctions, the obvious relationship between organ dysfunctions and mortality has been widely documented. Dynamic measurements of the SOFA score assess response to treatment and can be used to search for perpetuating sources of severity and reassess the treatment plan.

The primary objective of this study will be to assess the impact of an admission SOFA score equal to or greater than 2 and subsequent interventions on outcomes related to the 48-hour delta SOFA on ICU and hospital mortality, length of stay in the ICU, duration of mechanical ventilation, time of vasoactive drug use.

Patients will be divided into three groups: those who did not trigger the SOFA trigger on admission to the ICU (Group 1), those who triggered the SOFA trigger and improved on the third day (Group 2) and, finally, those who triggered the SOFA trigger and worsened on the third day (Group 3).


Eligibility Criteria:
Inclusion Criteria:

* Included all patients over 18 years old admitted to the ICU during the study period

Exclusion Criteria:

* Excluded were patients who remained in the ICU for a period of less than 48 hours and pregnant women
Stress Reduction Intervention for Women With Ischemic Heart Disease

This is a single center, randomized controlled trial which will include women with ischemic heart disease to receive either a self-directed stress reduction program delivered through a smart-phone application or activity tracking only for the first month ("early SR intervention" and "delayed SR intervention", respectively). Patients will be monitored for 1 month for application use and step counts via telephone or email interview and/or collection of screen-captured data. Baseline questionnaires will be repeated at the end of one month to assess for all primary and secondary measures, at which time the control group (activity tracking only) will be introduced to the intervention program. The early SR intervention group will not receive a new intervention but will be encouraged to continue using the app. Data will be collected for an additional 2 months with all participants in both groups. After the three-month study period, the study will close with the collection of final questionnaire data.


Eligibility Criteria:
Inclusion Criteria:

* Presence of ischemic heart disease as defined by one or more of the following within the last 2 years:
* Positive stress test
* Admission for ACS, PCI, or CABG
* Typical or atypical ischemic symptoms within one month of enrollment
* On stable dose of anti-anginal medications for at least 2 months
* Able and willing to provide informed consent and comply with all aspects of the protocol
* Owns a smartphone with the ability to download applications for stress reduction and activity tracking
* English-speaking (apps are not available in other languages)

Exclusion Criteria:

* Planned for revascularization during the study period
* Self-reported or chart-reviewed diagnosis of psychotic disorder including schizophrenia or schizoaffective disorder, bipolar disorder
* Current participation in a cardiac rehab program or planned participation during the study period
New Approaches to Cocaine Abuse Medications (A) - 6

The purpose of this study is to measure the effect of desipramine in cocaine abusers selected for major depression or dysthymia.

This is a randomized, 12-week, double-blind, 'placebo-controlled trial of outpatients meeting DSM-III-R criteria for cocaine dependence and major depression or dysthymia (by SCID interview). Participants were treated with desipramine, up to 300 mg per day, or matching placebo. All patients received weekly individual manual-guided relapse prevention therapy. Weekly outcome measures included the Clinical Global Impression Scale, self-reported cocaine use and craving, urine toxicology, and the Hamilton Depression Scale.

Eligibility Criteria:
Inclusion:

1. Meets DSM-IV criteria for current cocaine dependence.
2. Used cocaine at least one day in the past month.
3. Currently meets DSM-IV criteria for Major Depression or Dysthymia.
4. Depressive disorder is either:

   1. primary (antedates earliest lifetime substance abuse or
   2. persistent during 6 months of abstinence in the past or
   3. at least 3 months duration in the current episode
5. Age 18-60.
6. Able to give informed consent and comply with study procedures.

Exclusion:

1. Meets DSM-IV criteria for past mania (i.e. bipolar disorder), schizophrenia or any psychotic disorder other than transient psychosis due to drug abuse.
2. History of seizures.
3. History of allergic reaction to desipramine or imipramine.
4. Chronic organic mental disorder.
5. Significant current suicidal risk.
6. Pregnancy, lactation or failure in sexually active female patients to use adequate contraceptive methods.
7. Unstable physical disorders which might make participation hazardous such as hypertension, hepatitis or diabetes.
8. Coronary vascular disease as indicated by history or suspected by abnormal ECG or history or cardiac symptoms.
9. Cardiac conduction system disease as indicated by QRS duration \>0.11.
10. Current use of other prescribed psychotropic medications within the last 2 weeks.
11. History of failure to respond to a previous adequate trial of desipramine or another tricyclic antidepressant.
12. Currently meets criteria for another substance dependence disorder (DSM-IV) other than nicotine, marijuana or alcohol.
Prognostic Value of Delta LUS Score of Patients Hospitalized for Acute Heart Failure

prognostic value of delta LUS score of patients hospitalized for acute heart failure within 30 days of discharge.

The aim of our study is to evaluate the contribution of the variation of the LUS score performed at the time of admission (LUS1) and at discharge (LUS2) in predicting the clinical course of patients admitted for acute cardiac decompensation 30 days after discharge.

Delta LUS score=((LUS2-LUS1) \*100)/LUS1

Eligibility Criteria:
Inclusion Criteria:

* Patients aged over 18 years,
* Patients hospitalized in the emergency department for dyspnea having as etiology an acute heart failure and in whom will be performed two pulmonary ultrasound examinations (at entry and exit).

Exclusion Criteria:

* Age less than 18 years
* Dyspnea of non-cardiac etiology (cause: pulmonary, traumatic, toxic...)
* Altered state of consciousness (Glasgow score\<14)
* Hemodynamic instability: presence of peripheral signs of shock, use of vasoactive drugs
* Mechanical ventilation from the outset
* Cardiorespiratory arrest
* Inability to give consent to the study
* Missing one of two ultrasound examinations
* Unable to make telephone contact after one month.
Clinical Validation of iCare IC1000 Tonometer

Clinical validation of iCare IC1000 tonometer per ANSI Z80.10:2014 standard


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years

Exclusion Criteria:

* Subjects with only one functional eye
* Subjects having poor or eccentric fixation in the study eye
* High corneal astigmatism \>3D in the study eye
* Central corneal scarring
* History of prior incisional glaucoma surgery or corneal surgery, including corneal refractive laser surgery in the study eye
* Microphthalmos
* Buphthalmos
* Contact lens use within one week of continuous wear and within one hour if lens is worn occasionally
* Dry eyes (clinically significant)
* Lid squeezers - blepharospasm
* Nystagmus
* Keratoconus
* Any other corneal or conjunctival pathology or infection relevant to this study
* Central corneal thickness greater than 600 µm or less than 500 µm in the study eye
* Cataract Extraction within last 2 months in the study eye
Incontinence Management System ICU Field Evaluation

The objective of this Field Evaluation is to assess usage and satisfaction associated with the Hill-Rom Incontinence Management System.


Eligibility Criteria:
Inclusion Criteria:

* Patients with urinary, fecal, or dual incontinence who are ≥ 18 years old
* The patient, or the patient's legal authorized representative (LAR), is willing and able to provide written informed consent

Exclusion Criteria:

- Patients that are considered to be near death or require palliative care
Assessing the Efficiency of Cognitive Group Therapy for Patient With Subjective Memory Complains Using the WebNeuro System From Brain Resource(BRC)

assessing the Efficiency of cognitive group therapy for patients with subjective memory complains, using the neuropsychological computerized assessment of WebNeuro by Brain resource (BRC).

the study includes patients with subjective memory complains - who are concerned about having memory problems, that passed successfully the conventional basic cognitive assessment and who are not demented.

the patients were referred to our occupational therapy clinic for cognitive group therapy.

the aim of the study is to assess the efficiency of such therapy, using the neuropsychological computerized assessment of WebNeuro by Brain resource (BRC). the computerized assessment last 40 minutes and provide information about different cognitive aspects compared to a norm according to age, sex and education.

each patient will pass the neuropsychological computerized assessment twice: at the beginning of the study and after participating in the cognitive group therapy.

the cognitive group therapy is composed of eight meetings including information about memory processes, learning and practicing tools and strategies to improve cognition and memory.

each individual will be his one control, we will compare the patient achievements in the different cognitive aspects before and after the cognitive intervention.

our hypothesis is that the cognitive group therapy will improve the participants achievements in the neuropsychological computerized assessment.

Eligibility Criteria:
Inclusion Criteria:

* age 50 years old and more
* 8 years of education
* know reading and writing in hebrew
* know how to use the computer

Exclusion Criteria:

* neurologic or psychiatric conditions: apraxia, aphasia, depression, brain tumor
Atrasentan Spermatogenesis and Testicular Function

This study is being conducted to evaluate the effects of Atrasentan on sperm production and testicular function in male subjects with Type 1 or 2 Diabetes and Nephropathy.

This study included 2 periods: a Treatment Period (up to 26 weeks) followed by an Observational Period (up to an additional 52 weeks).


Eligibility Criteria:
Inclusion Criteria:

* Males 30 to 75 years of age
* Type 1 or 2 diabetes and receiving treatment with at least one anti-hyperglycemic medication and angiotensin-converting enzyme inhibitors (ACEi)/angiotensin receptor blockers (ARB) (renin-angiotensin system \[RAS\] inhibitor)
* Estimated Glomerular Filtration Rate (eGFR) equal to or greater than 35 mL/min/1.73 m\^2 with the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) Formula and Urine Albumin-to-Creatinine Ratio (UACR) equal to or greater than 30 and less than 5,000 mg/g creatinine.
* Able to provide a semen specimen at the required intervals.
* Baseline sperm concentration equal to or greater than 30 million per mL.

Exclusion Criteria:

* Treatment with hormone suppressive agents or cancer chemotherapy within the 6 months prior to the initial screening visit or planned during the study.
* History of severe peripheral edema or facial edema unrelated to trauma or history of myxedema in the prior 4 weeks prior to screening.
* History of pulmonary hypertension, pulmonary fibrosis or any lung disease requiring oxygen therapy.
* Documented diagnosis of heart failure, previous hospitalization for heart failure or current or constellation of symptoms (dyspnea on exertion, pedal edema, orthopnea, paroxysmal nocturnal dyspnea) felt to be compatible with heart failure, that was not explained by other causes, and for which there was a change in medication or other management directed at heart failure.
* Currently receiving or has received hormone replacement therapy within 6 months prior to screening.
Trial of the Reactogenicity, Safety and Immunogenicity of the Flu-M Vaccine Manufactured by FSUE SPbSRIVS FMBA

To trial the reactogenicity, safety and immunogenicity of the Flu-M inactivated split influenza vaccine in volunteers aged 18-60 years

All subjects will be followed up for 21 days post-randomization. The subjects will further be assessed at 2 days, 7 days, 21 days following the booster vaccination. Blood samples will be collected for reactogenicity and safety and immunogenicity assessments before injection and 21 days after vaccination.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent of the volunteers to participate in the clinical trial;
* Healthy volunteers (men and women) aged 18-60 years;
* Volunteers able to fulfill requirements of the protocol (fill out the patient's diary, come to follow-up visits);
* If the participant is female, she was required to have negative pregnancy test results and use contraceptives throughout the follow-up period (complete contraception of women of reproductive period)

Exclusion Criteria:

* Allergic reactions to chicken protein or any previous influenza vaccination;
* Leukemia, cancer or a positive reaction to human immunodeficiency virus infection, hepatitis B and C, syphilis in the past medical history;
* Volunteers who received immunoglobulin or blood products within the last 3 months before the trial;
* Guillain-Barré syndrome (acute polyneuropathy) in the medical history;
* Long-term use (more than 14 days) of immunosuppressants or other immunomodulatory drugs for 6 months prior to the trial.
* Any confirmed or suspected immunosuppressive or immunodeficiency condition;
* Respiratory, cardiovascular failure, impaired liver or kidney function found during a physical examination or laboratory tests during Visit 1;
* Severe birth defects or serious chronic diseases, including any clinically significant chronic diseases of lungs, kidneys, cardiovascular, nervous system, psychiatric diseases or metabolic disorders, confirmed by medical history or objective examination;
* Being (or having been) a patient of a tuberculosis dispensary and/or narcological dispensary and/or neuropsychiatric dispensary;
* acute infectious and/or non-infectious diseases at the time of inclusion in the trial;
* Exacerbation of chronic diseases;
* chronic alcohol abuse and/or use of drugs in the past history;
* Pregnancy and lactation;
* Participation in another clinical trial within the last 3 months;
* Immunization with influenza vaccines in the last 6 months
Both Short- and Long-term Outcome Differences According to Patient Frailty

The evaluation for cancer treatment successful has been used by overall survival rate and/or postoperative complications, especially surgical area. Now postoperative QOL has been more importantly required. Therefore this study was conduced to investigate the association between postoperative outcomes and patients frailty.


Eligibility Criteria:
Inclusion Criteria:

* surgical patients

Exclusion Criteria:

* a body weight loss of \>10% during the 6 months before surgery; the presence of distant metastases; or seriously impaired function of vital organs because of respiratory, renal, or heart disease
Study of Enzalutamide (Formerly MDV3100) as a Neoadjuvant Therapy for Patients Undergoing Prostatectomy for Localized Prostate Cancer

The purpose of this study is to determine if enzalutamide is an effective therapy in treating localized prostate cancer prior to prostatectomy.


Eligibility Criteria:
Inclusion Criteria:

* Willing to provide informed consent
* 18 years of age or older
* Histologically confirmed adenocarcinoma of the prostate
* Must be a candidate for radical prostatectomy and considered surgically resectable

Exclusion Criteria:

* Stage T4 prostate cancer by clinical or radiologic evaluation
* Treatment with an investigational agent within 4 weeks prior to randomization
* Received therapy for other neoplastic disorders within 5 years
* Hypogonadism or severe androgen deficiency
Inhaled Nitric Oxide in Neonates With Elevated A-a DO2 Gradients Not Requiring Mechanical Ventilation

The purpose of this pilot study is to evaluate whether administration of nitric oxide (NO)gas by oxygen hood at 20 ppm significantly increases PaO2, as compared to placebo gas (oxygen), within one hour of initiation and with no significant adverse effects.

It is possible that administration of inhaled NO to neonates with abnormal gas exchange earlier, rather than later as a rescue therapy in a moribund state, might accelerate the transition of the circulation from the fetal to neonatal physiology and improve oxygenation. This may in turn decrease the need for mechanical ventilation, its associated morbidity and perhaps even ECMO.

This study is designed as a pilot study to evaluate the physiologic efficacy (rather than effect on clinical outcomes) of NO administered by hood in improving oxygenation of neonates with elevated A-a DO2.

Eligibility Criteria:
Inclusion criteria:

* Gestational age \>34 completed weeks (\>=35)
* Age \<48 hours
* A-a DO2 400 to 600, on two post-ductal arterial blood gases one hour apart, while on 100% O2 by oxygen hood
* Post-ductal arterial access
* Admitted to The University of Alabama Birmingham Regional NICU

Exclusion criteria:

* Cardiac disease (structural disease with right to left or mixing lesions), not including patent ductus arteriosus (PDA) or patent foramen ovale (PFO)
* Rapid deterioration requiring mechanical ventilation before entry into the study
* Major malformations
* Major neurologic or metabolic disorder or other illness leading to hypoventilation and hypercarbia
Using Technology to Promote Mental Acuity

The study plans to test the effectiveness of behavioral economics based incentives to promote the daily use of computer programs designed to improve memory and mental acuity. Subjects will be recruited from the Pittsburgh metropolitan area. The primary objective is to determine the impact of structured financial incentives on the number of computer-based cognitive exercises completed during a 3 month intervention period.


Eligibility Criteria:
Inclusion Criteria:

* 55-80 years old

Exclusion Criteria:

* Unable to read or understand the informed consent form
Personalized PRRT of Neuroendocrine Tumors

In this study, peptide receptor radionuclide therapy (PRRT) with 177Lu-Octreotate (LuTate) will be personalized, i.e. administered activity of LuTate will be tailored for each patient to maximize absorbed radiation dose to tumor, while limiting that to healthy organs.

The purpose of this study is to:

* Assess the objective (radiological), symptomatic and biochemical response rates following an induction course of personalized PRRT;
* Assess the overall, the disease-specific, and the progression-free survival following P-PRRT;
* Correlate therapeutic response and survival with tumor absorbed radiation dose;
* Evaluate the acute, subacute and chronic adverse events following P-PRRT;
* Correlate toxicity (i.e. occurence and severity of adverse events) with absorbed radiation doses to organs at risk;
* Optimize the quantitative SPECT imaging-based dosimetry methods in a subset of 20 patients (sub-study funded by the Canadian Institutes of Health Research).

This study also has a compassionate purpose, which is to provide access to PRRT to patients.

A prospective, single-center, non-comparative, open phase 2 study. In this study, personalized peptide receptor radionuclide therapy (P-PRRT) with 177Lu-Octreotate (LuTate) will be administered to patients with progressive and/or symptomatic inoperable neuroendocrine tumors (NET) of any origin expressing the somatostatin receptor.

The primary objective to assess the objective response rate at 3 months following a four-cycle induction course of P-PRRT will be assessed for at least the first 85 participants.

This study as a compassionate aim to provide access to personalized PRRT patients at CHU de Québec - Université Laval center, and therefore this study has no pre-determined recruitment period duration or limited number of participants, and may remain open as long as necessary to fulfill this aim.

The study will continue until all participants have completed a minimum follow-up of 5 years. Interim analyses will be conducted annually.

Eligibility Criteria:
Inclusion Criteria:

* Patient suffering from a progressive and/or symptomatic NET (any site);
* Patient ineligible to, or refusing a potentially curative treatment such as surgical resection;
* Patient who did not respond, is intolerant or refuses other indicated and available palliative treatments;
* Demonstration of overexpression of somatostatin receptor by tumor lesions by scintigraphic imaging (Octreoscan or 68Ga positron emission tomography.

Exclusion Criteria:

* Pregnancy;
* Breastfeeding;.
* Very limited survival prognosis (i.e. less than a few weeks, because of the NET disease or any other condition) or Eastern Cooperative Oncology Group (ECOG) 4 performance status;
* Inability to obtain informed consent of the participant.