cyrilzakka/clinical-trials huggingface dataset:
Carvedilol Effect in Preventing Chemotherapy - Induced Cardiotoxicity

The purpose of this study is to evaluate if carvedilol can prevent the cardiotoxicity after chemotherapy in breast cancer.

Dilated cardiomyopathy secondary to chemotherapy accounts for approximately 1% of all dilated cardiomyopathies.

Initial studies showed beneficial effect of the use of carvedilol for the prevention of chemotherapy-induced cardiomyopathy. This study has the objective to evaluate the effectiveness of carvedilol for the prevention of chemotherapy-induced cardiomyopathy. Will be selected 200 patients referred for chemotherapy that includes anthracyclines for breast cancer.These patients will be randomized to carvedilol or placebo and will have periodic assessment of cardiac function with echocardiography and biomarkers until complete chemotherapy and 24 months later.

Eligibility Criteria:
Inclusion Criteria:

Patients diagnosed with breast cancer, with an indication of chemotherapy that includes anthracycline.

Exclusion Criteria:

Failure analysis of ventricular function; History of chemotherapy or radiotherapy; Previous symptoms of heart failure; Presence of cardiomyopathy; Presence of Coronary Artery Disease; Aortic valve disease or moderate to severe mitral regurgitation; Contraindication to the use of β-blocker; Use of inhibitors of angiotensin converting enzyme, angiotensin receptor blockers or β-blockers.

Patients with HER 2 expression
A Study to Investigate Safety, Tolerability and Pharmacokinetics of Single and Repeat Doses of CHF6333 in Healthy Subjects

Human Neutrophil Elastase (HNE) plays a pivotal role in innate immunity and in neutrophilic lung inflammation that characterized many diseases. CHF 6333 is a potent and 24h-durable inhibitor of HNE, developed as Dry Powder Inhaler (DPI) formulation. This study is designed to investigate the tolerability, safety and pharmacokinetics of inhaled CHF6333 DPI in healthy male subjects.

The study will comprise two parts:

Part 1 will consist of two alternated cohorts of healthy male subjects to assess the safety, tolerability and pharmacokinetics of Single Ascending Dose (SAD) of CHF6333.

Part 2 will consist of four sequential cohorts of healthy male subjects to assess the safety, tolerability and pharmacokinetics of Multiple Ascending Dose (MAD) of CHF6333


Eligibility Criteria:
Inclusion Criteria:

* Male subjects aged 18-55 years
* BMI between 18-30 kg/m2
* Non smokers
* Lung function above 80% of predicted normal value
* Healthy subjects based on medical evaluation including medical history, physical examination, laboratory tests and cardiac testing

Exclusion Criteria:

* Any clinically relevant abnormalities and/or uncontrolled diseases
* Abnormal laboratory values
* Recent respiratory tract infection
* Hypersensitivity to the drug or excipients
* Positive serology results
* Positive cotinine, alcohol, drug of abuse tests
* Unsuitable veins for repeated venepuncture
Blood Pressure Monitor Clinical Test (Cuff Range: 13.5cm-19.5cm）

The purpose of this study is to verify the accuracy of the blood pressure cuffs with blood pressure monitor device.

Cuff circumference is 13.5cm-19.5cm.


Eligibility Criteria:
Inclusion Criteria:

* Normal blood pressure and hypertensive patients over 12 years old.

Exclusion Criteria:

* Patients with serious arrhythmias or a high frequency of arrhythmias
* Pregnant woman
* Other investigators believe that it is not suitable to participate in this clinical trial
Impact of CMV-Specific Immune Reconstitution At the End of Letermovir Prophylaxis on the Development of Late Cytomegalovirus Infection in Hematopoietic Stem Cell Transplant Recipients (INMUNOEND)

Cytomegalovirus (CMV) infection is a common complication in patients undergoing hematopoietic stem cell transplantation (SCT). Fixed-duration letermovir (LTV) prophylaxis during the first 100 days post-SCT is effective and safe in preventing this infection, although it may be associated with a delay in CMV-specific immune reconstitution. Hence, it is needed a study to evaluate whether the absence of CMV-specific immune reconstitution at the end of LTV prophylaxis is associated with the development of late infection. This could facilitate the individualization of CMV prophylaxis duration in these patients.

Methods and analysis: INMUNOEND is a multicenter, prospective, observational, non-interventional study including CMV seropositive patients undergoing allo-SCT who receive LTV prophylaxis during the first 100 days post-SCT. Immunological and virological monitorization will be conducted until day +200 post-SCT. The primary outcome variable is the percentage of patients who develop clinically significant CMV infection up to day +200 post-SCT after completing LTV prophylaxis. Data collected will include: baseline characteristics of the hematological diseases and comorbidities, variables related to SCT (i.e. engrafment, graft-versus-host disease, use of letermovir and CMV replication) and variables related to CMV-specific immune reconstitution.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years.
* CMV seropositivity (positive IgG) in the recipient at the time of SCT.
* First allogeneic hematopoietic stem cell transplant recipient (bone marrow, peripheral blood, or cord blood).
* Within the first 28 days post-SCT at the time of inclusion.
* Indication for LTV prophylaxis within the first 28 days post-transplant up to 100 days post-SCT, according to the criteria established in each center.

Exclusion Criteria:

* CMV seronegativity (negative IgG) in the recipient at the time of transplant.
* Previous allogeneic stem cell transplant (patients with a prior autologous transplant are allowed to be included).
* History of CMV disease in the 6 months prior to inclusion.
* Need for preemptive therapy in the month prior to inclusion in the study.
* Received any of the following in the 14 days prior to inclusion: Ganciclovir, valganciclovir, foscarnet, acyclovir (at doses \>3200 mg orally per day or \>25 mg/kg IV per day), valacyclovir (at doses \>3000 mg orally per day), famciclovir (at doses \>1500 mg orally per day).
* Received any of the following in the 30 days prior to screening: Cidofovir, CMV hyperimmune immunoglobulin, any CMV antiviral in the investigational phase.
* Suspected or confirmed hypersensitivity reaction to the LTV formulation or any of its components.
* Severe hepatic insufficiency (defined as Child-Pugh class C).
* History of primary immunodeficiency prior to transplant.
* Participation in a clinical trial involving the administration of CMV vaccines, other investigational CMV drugs, or monoclonal antibodies.
MD.2 Medication Dispenser Medication Adherence Study

The objective of this study is to quantify the benefits of using the MD.2 on health outcomes.

A sizeable portion of admissions to hospital and even nursing homes can be avoided if individuals with medication management problems were provided assistive devices to assist with their medications. The MD.2 medication dispenser and monitoring system was developed by Interactive Medical Developments LC and may offer increased support to the elderly with fewer human resources and a substantially reduced cost to the public health system. A rigorous evaluation of this technology has not been conducted. The objective of this Phase III clinical trial (Phase II of this STTR Fast Track Application) is to quantify the benefits of using the MD.2 on health outcomes. The specific aims are to: (1) Quantify healthcare utilization including hospitalizations and emergency room visits for MD.2 clients compared to control clients, (2) Determine the length of time in case management for MD.2 clients compared to control clients, (3) Measure changes in caregiver burden between those with the MD.2 and those with usual medication routines and (4) Determine if cognitive and functional characteristics influence compliance rates among the MD.2 clients and control clients. This study will be conducted in all counties in four of the Area Agencies on Aging in Iowa (who participated in the Phase I study), with the Veteran's Administration(VA)in Iowa, and with Area Agencies on Aging in Illinois. One hundred and fifty clients will be randomized to receive the MD.2 and 150 clients will be randomized to the control group. Primary caregivers for these 300 subjects will also be recruited. Nurses employed by Interactive Medical Developments LC will collect all data. From homecare charts/claims, age, sex, residence, living status, social support, activities of daily living, instrumental activities of daily living, cognition, medical conditions and medication lists will be obtained. Enrolled subjects will also complete an interviewer-administered survey of the Geriatric Depression Scale, SF-12 Health Status Inventory, self-reported medication compliance and recent hospitalizations and emergency room visits. Caregivers will complete the Caregiver Burden Interview. Poisson regression and Cox proportional hazards models will be the primary statistical approaches.

Eligibility Criteria:
Inclusion Criteria:

A client must:

* Be coming up for regular review in Case or Medication Management
* Require medication management services
* Have two or more doses of medication per day
* Have someone to fill MD.2
* Be in independent living (may be assisted living with NO medication management services)
* Be expected to live through follow-up period of six months
* Have an active phone line that can be utilized by the MD.2 system.

Exclusion Criteria:

A client cannot have/or be the following:

* Have someone available to administer medications for every dose
* Have someone in household who is likely to interfere with MD.2
* Blind AND deaf
* Eligible for hospice
* An MD.2 currently
Burden of Illness and Treatment Assessment of Patients With Dry Eye Disease: A Cross-Sectional Survey of Real-World Patients With Dry Eye Disease in the US

This study employed secondary database analysis of the Adelphi Dry Eye Disease (DED) Disease Specific Programme™ (DSP™), a templatized cross-sectional survey with retrospective data collection that is administered by Adelphi to a convenience sample of patients diagnosed with DED, and their consulting physicians in the United States. In addition to the survey data, the DED DSP also included recorded medical history data as reported by physicians (optometrists, ophthalmologists or refractive surgeons).


Eligibility Criteria:
Inclusion Criteria:

Main Sample:

* ≥ 18 years of age.
* Physician-confirmed DED diagnosis (at time of data collection).

Xiidra® Oversample:

* ≥ 18 years of age.
* Physician-confirmed DED diagnosis (at time of data collection).
* Have a current prescription for Xiidra® for their DED (at time of data collection).

Exclusion Criteria:

Main Sample:

• Involved in a DED clinical trial (at time of data collection).

Xiidra® Oversample:

* Involved in a DED clinical trial (at time of data collection).
* Included in the main sample previously.
Muscle Relax Affects Outcomes of Robotic Surgery

During robotic laparoscopic surgery, a high intraperitoneal pressure may result in high airway pressure and inadequate perfusion of the abdominal organs, and as a result the postoperative outcomes. Degree of neuromuscular blockade (NMB) can affect the intraperitoneal pressure. In this study, the patients undergoing robotic laparoscopic surgery will be assigned to deep NMB group and moderate NMB group. Perioperative outcomes including maximal intraperitoneal pressure, maximal intraoptic pressure, quality of emergence, postoperative pain, and incidence of postoperative respiratory complication will be compared. The results of this study will provide evidence for optimizing NMB protocol of robotic laparoscopic surgery.


Eligibility Criteria:
Inclusion Criteria:

* patients scheduled for elective robotic laparoscopic surgery under general anesthesia
* American Society of Anesthesiologists status 1-2
* Body mass index of 18-30kg/m2
* Patients scheduled to be positioned in trendelenburg position during surgery

Exclusion Criteria:

* Patients allergic to rocuronium
* Patients with neuromuscular dysfunction
* Patients with existed pulmonary diseases
* Patients with hepatic or renal dysfunction
Femoral Nerve Block Compared to Exparel in Total Knee Replacement

The main objective of the study is to determine if intrarticular injection with liposomal bupivicaine (Exparel) provides better postoperative pain relief and functional outcome following total knee replacement (TKR) than the current standard New England Baptist Hospital regimen of femoral nerve block combined with intraarticular injection of a standard bupivicaine solution.

A prospective, single blind study comparing femoral nerve blockade and intraarticular posterior capsular injection to interarticular injection of bupivicaine and liposomal bupivicaine (Exparel) alone.

Eligibility Criteria:
Inclusion Criteria:

• Patients between the ages of 18 - 73 who are undergoing primary, unilateral, Total Knee Replacement at the New England Baptist Hospital in Boston, Massachusetts are eligible to participate.

Exclusion Criteria:

* Patients with Revision or Complex Total Knee Replacements and are under the age of 18, or over the age of 73 will be excluded.
* Patients with an ASA 4 level will be excluded.
* Patients with a Body Mass Index of less than 20, and over 40, will be excluded.
* Patients taking preoperative narcotics, patients with extreme sensitivity or allergy to narcotics or local anesthetics, and patients using opioid medications for at least 3 months leading up to surgery, will also be excluded.
Study to Evaluate the Effects of Age & Gender on PK, Safety & Tolerability of HCV-796 Administered to Healthy Subjects

This study is an open-label, single-dose, parallel group study to evaluate the effects of age and gender on the pharmacokinetics, safety, and tolerability of HCV-796 administered orally to healthy subjects.


Eligibility Criteria:
Inclusion:

* Men or nonlactating and nonpregnant women, aged 18 to 45, and \>65 years.
* Men must agree to practice barrier contraception for 12 weeks after the last test article administration.
* Estimated (calculated) creatinine clearance must be within the age-appropriate normal range.

Exclusion:

* History of seizures.
* History of rhabdomyolysis.
* History of thyroid disease.
Savvy System Project

The study goal is to develop a web-based system that uses distance education methods and provides manuals and protocols to train, certify, and monitor the performance of interventionists to deliver the Savvy Caregiver program (Savvy), an evidence-based dementia family caregiver psychoeducation program. The system has a potential to increase the scalability of Savvy.

The number of People Living With Disability (PLWD) in the U.S. will rise from 5.7 million to 14 million by 2050, and the number of family caregivers who maintain these persons in the community will rise proportionately from 15 million at present. Several psychoeducation programs, including Savvy, have successfully ameliorated the adverse effects of caregiving, but these programs are only minimally available and accessible.

The study goal is to develop a web-based system that uses distance education methods and provides manuals and protocols to train, certify, and monitor the performance of interventionists to deliver the Savvy Caregiver program (Savvy), an evidence-based dementia family caregiver psychoeducation program. The system has a potential to increase the scalability of Savvy.

Eligibility Criteria:
Inclusion Criteria:

Organizational Leaders

1. Able to understand and speak English
2. Affiliated with an organization serving caregivers for family members living with Alzheimer's disease or related dementias
3. 18 years or older

Interventionists

1. Able to understand and speak English
2. Affiliated with a participating organization
3. 18 years or older

Caregivers

1. Able to understand and speak English
2. Caregiver for a person living with Alzheimer's disease or related dementias (PLWD) who is providing informal care for at least 3 hours a day. PLWD should not be bound for institutional care within the next 6 months.
3. 18 years or older
A Novel Diagnostic Method for Exotropia Using Video-oculography

Thirty-four subjects with constant exotropia were included. Two independent ophthalmologists measured the angle of ocular deviation using alternate prism cover test (APCT). The video files and data with the changes in ocular deviation during the alternate cover test were obtained using video-oculography (VOG). To verify the accuracy of VOG, Investigator compared the value obtained using VOG and the angle of a rotating model eye, and subsequently made a new linear equation using these data. The calculated values obtained using VOG were compared with those obtained using APCT to determine the diagnostic accuracy of VOG.


Eligibility Criteria:
Inclusion Criteria:

* have horizontal strabismus, cooperative, visual acuity \>= 1.0/1.0

Exclusion Criteria:

* have vertical strabimus\> 5prism diopter, not cooperative, no agree
The Association Between the Duration of Acute Kidney Injury and New-onset Chronic Kidney Disease After Cardiac or Thoracic Aortic Surgery

The investigators aimed to evaluate the association between the duration and stage of acute kidney injury (AKI) and the development of chronic kidney disease during postoperative three years in patients undergoing cardiac or thoracic aortic surgery.

Postoperative acute kidney injury (AKI) has been investigated as an important contributor to postoperative morbidity and mortality after cardiovascular surgery. Also, temporary worsening of renal function after aortic surgery is associated with higher long-term mortality. Although the associations between AKI and chronic kidney disease (CKD) in medical or other surgical settings were reported, only a few studies evaluated this relationship in patients undergoing cardiac surgery. More specifically, the association of the severity or duration of AKI with the risk of the development of new-onset CKD after cardiac surgery has not been clearly elucidated.

It would be important to find predictors of the long-term renal function or risk factors for the development of CKD after cardiac surgery because postoperative management of high-risk patients to develop long-term renal dysfunction may prevent further deterioration in renal function and improve patient prognosis.

The investigators aimed to evaluate (1) the long-term renal function after cardiac surgery and (2) the association between the duration and stage of acute kidney injury (AKI) and the development of chronic kidney disease during postoperative three years in patients undergoing cardiac or thoracic aortic surgery.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients who underwent cardiac or thoracic aortic surgery under cardiopulmonary bypass at Seoul National University Hospital between 2008 and 2017

Exclusion Criteria:

* Those with off-pump coronary artery bypass
* Missing baseline serum creatinine
* Missing postoperative serum creatinine values of more than three among seven postoperative days
* Preoperative baseline chronic kidney disease with estimated glomerular filtration rate \<60 ml/min/1.73m2
Clinical Study on Disposable Sterile Urinary Catheter

This study is a multicenter, randomized controlled study, with the urinary tract infection rate at the time of catheter insertion for 1 week as the primary end point. By comparing the clinical safety and effectiveness of two kinds of urethral catheters, to evaluate the clinical application effect of one kind of urethral catheters.


Eligibility Criteria:
Inclusion Criteria:

* 18-80 year old patients;
* Retained catheter ≥ 7 days;
* Patients who were conscious and had good communication skills and volunteered to participate in the study.

Exclusion Criteria:

* Pregnant and lactating female patients;
* Diabetes patients;
* Patients allergic to sulfadiazine, silica gel and stainless steel;
* Urethral malformation, acute urethral injury, prostate disease, intermittent catheterization, suprapubic cystostomy and other patients who are not suitable for catheterization;
* Patients who have used urinary catheters for a long time or had catheters retained within one week;
* Patients who are participating in other clinical trials that interfere with this trial.
Cutivate Lotion HPA Axis Pediatric Study

A multi-center, open-label, Phase IV, unblinded study using Cutivate (fluticasone propionate, 0.05%)lotion and it's possible effects on the HPA axis of infants diagnosed with atopic dermatitis.


Eligibility Criteria:
Inclusion Criteria:

* Subjects are 3-12 months of age
* Subjects diagnosed with Atopic Dermatitis (AD) and have ≥35% of Body Surface Area
* Subjects meet protocol specific AD signs and symptom severity score

Exclusion Criteria:

* Subjects with conditions effecting the HPA Axis
* Subjects with clinically significant systemic disease
* Subjects who require treatment with systemic or topical retinoids during the study
* Subjects who have been treated with various chronic therapies identified in the protocol
* Subjects who have received other investigational drug treatment within 30 days prior to study entry
Effect of Dopaminergic Medication on Recovery of Aphasia

The investigators have been offering computer assisted therapy of aphasia (CAT) as a complement to traditional treatments to aphasia patients of the "Service of Neurorehabilitation" for some years. The investigators have shown its efficacy in hospitalised patients with recently acquired aphasia.

In addition to studies stressing the importance of treatment intensity, several studies suggest that pharmacological treatment can also improve recovery after a cerebral lesion. The underlying idea is that the administration of medication influencing the system of neurotransmitters can play a role in functional recovery. Studies have assessed mainly substances acting on the dopaminergic (amphetamine and bromocriptine) and GABAergic system (piracetam).

The main objective of the present study concerns the evaluation of the effects of levodopa on recovery of anomia in patients with aphasia. In particular, the investigators use CAT to control intensity and quality of therapy and they will assess whether the administration of levodopa promotes recovery.

In each patient, two periods of anomia therapy with CAT, each performed with a different word list, will be compared. In addition to speech therapy, each period will be associated with the administration of either levodopa and benserazide (Madopar ®), or placebo. Evaluations at baseline and after each treatment period will be performed with the material and denomination battery


Eligibility Criteria:
Inclusion Criteria:

* Patient with aphasia hospitalised at the "Service of neurorehabilitation" with presence of anomia absence of comprehension deficits, absence of executive or apraxic dysfunctions that might impede the handling of keyboard or mouse, absence of stereotypies or perseverations dominating the aphasic symptoms.

Exclusion Criteria:

* Patients who do not have their ability to judge or who suffer from Parkinson's syndrome requiring dopaminergic treatment will be excluded. Moreover, absolute medical contraindications for the medication will be respected: known hypersensitivity to one of the components, patients taking MAO inhibitors or sympathomimetics, severe hormonal, renal, hepatic, or cardiac affections, pregnancy or breastfeeding, women at reproductive age without reliable contraception, angle closure glaucoma, psychosis or severe neurosis, age \< 25 years, malign melanoma, or planned anesthesia during the study period + 48 hours.