cyrilzakka/clinical-trials huggingface dataset:
Role of Human Milk Bank in the Protection of Severe Respiratory Disease in Very Low Birth Weight Premature Infants

Acute respiratory infections are the leading cause of hospitalization in premature infants worldwide. Severity rates are particularly high in developing countries. Numerous viruses can cause severe disease, but the most frequent agent of hospitalization is respiratory syncytial virus (RSV). In a recent study in Argentina, 58% of RSV infected VLBW infants required hospitalization and 19% required mechanical ventilation. One every twenty infected infants died. Unlike industrialized nations, VLBW infants in developing countries often lack access to prophylaxis against RSV with a commercially available monoclonal antibody (palivizumab). No vaccine or preventive intervention is available against any respiratory virus for infants younger than 6 months of age in developing countries and the public sector of most middle-income countries.

The protective role of breastfeeding against respiratory infections in developing countries is well established. But while similar beneficial effects have been described for premature infants, the dropout rate for breastfeeding in families exposed to the uncertainties and stress of the early months of life in the neonatal intensive care unit is very high. The World Health Organization recommends the use of Human Milk Donor Banks to feed infants that cannot be breastfed by their own mothers. These banks are established with the purpose of collecting, screening, processing (including pasteurizing), testing and distributing donated human milk. The potential benefit of donated milk against acute disease elicited by RSV is unknown. The investigators propose to study the role of supplemental donated human milk in the prevention of hospitalizations caused by RSV in non-breastfeeding premature infants. Since the investigators expect the benefits of breast milk to extend beyond protection against RSV, the effect of human milk against respiratory infections elicited by other viruses will also be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* VLBW preterm neonates (birth weight \<1,500 g at birth; gestational age \<37 weeks) born alive at any of the two participating maternity hospitals integrating our network in Argentina will be enrolled in the study after signature of informed consent.

Exclusion Criteria:

* VLBW infants older than one month of age (e.g.: transferred from another institution), or formula fed for over ten days, or with congenital heart disease, congenital anomalies of the respiratory tract (i.e.: tracheoesophageal fistula, pulmonary hypoplasia, diaphragmatic hernia), immune suppression, severe malformations affecting breathing (i.e. anencephaly) as well as infants who die prior to completion of the first questionnaire, or living more than 40 km away from the Hospital will be excluded from participation. Infants born from human immunodeficiency virus (HIV) positive mothers will also be excluded
Very Low Frequency Magnetic Fields in the Treatment of Fibromyalgia

The purpose of the study is to determine the effectiveness of treatment with very low frequency electromagnetic fields on the reduction of pain in patients with fibromylgia, disease presenting with widespread musculoskeletal pain usually associated with other symptoms such as stiffness, fatigue, sleep disturbances, depression, anxiety.


Eligibility Criteria:
Inclusion Criteria:

* Fibromyalgia diagnosed according to the criteria proposed by the American College of Rheumatology (ACR 2010)
* Subjects aged between 18 and 60 years

Exclusion Criteria:

* Pregnant patients
* Patients with pacemaker or other metal implants
* Systemic infectious disorders
* Neoplastic disorders
* Epilepsy
* Severe heart disease
Clinical Investigation of Erlotinib as an HCV Entry Inhibitor

Chronic Hepatitis C Virus (HCV) infection is a major cause of liver cirrhosis and hepatocellular carcinoma world-wide. Current combination therapy of pegylated interferon-alfa, ribavirin and protease inhibitors is limited by resistance and substantial side effects.

The investigators identified epidermal growth factor receptor (EGFR) as host factor for HCV infection. Inhibition of kinase function of EGFR by approved inhibitor Erlotinib (TarcevaTM) broadly inhibits HCV infection of all major genotypes including viral escape variants resistant to host immune responses.

Completed preclinical proof-of-concept studies in HCV cell culture and animal model systems demonstrate that inhibition of EGFR function by Erlotinib constitutes a novel antiviral approach for prevention and treatment of HCV infection (European patent application EP 08 305 604.4, Filing date: September 26, 2008; Inserm, Paris, France and Lupberger et al. Nature Medicine 2011).

Since Erlotinib (TarcevaTM) is an established approved drug for cancer treatment and has a well characterized safety profile in humans, the aim of the study is to investigate the safety, efficacy and pharmacokinetics of Erlotinib, a first-in-class entry inhibitor, for treatment of HCV infection in a randomized placebo-controlled double blind clinical trial in patients chronically infected with HCV. Following completion, this trial will set the stage for a further investigation of entry inhibitors as antivirals in combination with standard of care or direct antivirals such as HCV protease inhibitors. Thus, this randomized clinical trial will be an important step in the development of novel urgently needed antiviral therapies overcoming resistance.


Eligibility Criteria:
Inclusion Criteria:

* Chronic genotype 1b hepatitis C infection with detectable HCV RNA (\> 1x104 UI/mL)
* Naïve, relapser or non-responder to interferon with or without ribavirin
* Weight \> 45kg, BMI between 18 and 25 Kg/m2 who had a liver biopsy or liver FibroScan eliminating the presence of cirrhosis in the year before enrollment,
* Non-smoker or occasional smoker ( ie \< 3 cig/day)

Exclusion Criteria:

* HIV or HBV infection
* Cirrhosis or Liver decompensation
* Chronic liver disease non related to HCV
Sepraspray™ Laparoscopic Myomectomy Study

The purpose of this research study is to obtain preliminary data of the safety and effectiveness of Sepraspray in a limited number of patients who are under going a laparoscopic myomectomy. Sepraspray will be applied to the organs in the pelvic cavity following laparoscopic myomectomy. We will compare treatment with Sepraspray as a adhesion prevention barrier after laparoscopic myomectomy versus no adhesion barrier.


Eligibility Criteria:
Inclusion Criteria:

* The patient must be a premenopausal women with myomas associated with clinical symptoms deemed suitable for laparoscopic myomectomy and SLL.

Exclusion Criteria:

* Pregnant/lactating women.
* The patient has a history of hypersensitivity to exogenous carboxymethylcellulose products and/or hyaluronic acid.
* The patient's procedure resulted in entry of the endometrial cavity, or entry of the bowel including appendectomy.
Cardiovascular Diseases in HIV-infected Patients HIV-HEART Study: 7.5 Years Follow-up

Since the introduction of antiretroviral therapy life expectancy of HIV-infected persons is rising. Different cohorts are observing an increased risk for cardiovascular diseases in this aging HIV-infected population. Traditional cardiovascular risk factors like smoking are more frequent in HIV-infected persons. For example chronic inflammation due to HIV-infection and metabolic disorders also caused by some antiretroviral substances as special non-traditional risk factors in HIV-infected persons can influence the development of cardiovascular diseases additionally. Therefore new research focus in special risk profile associated with HIV-infection or antiretroviral treatment and prevention for HIV-infected patients is developing.

This present study is an ongoing prospective regional multicenter trial that was conducted to analyse the incidence, prevalence and clinical course of cardiovacular disorders in HIV-infected out-patients.

Cardiac disorders witch are associated with HIV are pericarditis, pleural effusion, pulmonary hypertension, dilated cardiomyopathy, heart failure, myocarditis, bacterial endocarditis and heart valve disorders. In addition to previously stated disorders of the heart, the premature atherosclerosis of coronary arteries, a further even more important disease of the heart in this patient population, went into the focus of most HIV-researchers and physicians.

A comprehensive detailed description of the study procedures had been previously published (European Journal of medical research 2007;12:243-248).

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Known HIV-infection
* Written informed consent

Exclusion Criteria:

* Acute cardiovascular disease
* Unstable hemodynamic status in the three weeks before inclusion
* Pregnancy
A Study of BR Alone Versus in Combination With Acalabrutinib in Subjects With Previously Untreated MCL

This study is evaluating the efficacy of acalabrutinib in combination with bendamustine and rituximab (BR) compared with placebo plus BR in subjects with previously untreated mantle cell lymphoma.

To evaluate the efficacy of acalabrutinib in combination with bendamustine and rituximab (BR) compared with placebo plus BR based on Independent Review Committee (IRC) assessment of progression-free survival (PFS) per the Lugano Classification for Non-Hodgkin Lymphoma (NHL) in subjects with previously untreated mantle cell lymphoma (MCL).

Eligibility Criteria:
Inclusion Criteria:

* Men and women, ≥ 65 years of age.
* Pathologically confirmed MCL, with documentation of a chromosome translocation t(11;14)(q13;q32) and/or overexpression of cyclin D1 in association with other relevant markers (eg, CD5, CD19, CD20, PAX5) .
* MCL requiring treatment and for which no prior systemic anticancer therapies have been received.
* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2.
* Agreement to use highly effective forms of contraception during the study and 6 months after the last dose of bendamustine, or 12 months after the last dose of rituximab, whichever is longest .

Exclusion Criteria:

* Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of first dose of study drug, or any Class 3 or 4 cardiac disease as defined by the New York Heart Association Functional Classification, or corrected QT interval (QTc) \> 480 msec (calculated using Friderica's formula: QT/RR0.33) at screening. Exception: Subjects with controlled, asymptomatic atrial fibrillation during screening are allowed to enroll on study.
* Malabsorption syndrome, disease significantly affecting gastrointestinal function, resection of the stomach, extensive small bowel resection that is likely to affect absorption, symptomatic inflammatory bowel disease, partial or complete bowel obstruction, or gastric restrictions and bariatric surgery, such as gastric bypass.
* Uncontrolled active systemic fungal, bacterial, viral, or other infection (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment), or intravenous anti infective treatment within 2 weeks before first dose of study drug.
* Concurrent participation in another therapeutic clinical trial.
Virtual Patients - An Interactive Educational Module for Higher Education

Popular Science Summary (for the whole project)

In modern healthcare, several challenges exist: short patient visits, highly specialized care, and limited opportunities for education and professional development among healthcare staff. In theoretical training efforts, it can be difficult to highlight and provide opportunities to practice complex patient interactions. The overall goal of this project is to evaluate the effects of an interactive educational module that includes training with virtual patients (VP). Single training sessions rarely lead to behavioral changes in clinical practice, but concrete training with a clear connection to clinical tasks can have a better effect.

In this research project, VPs will be part of an educational module at universities and colleges, where the overarching goal is for students to practice clinically relevant communication areas. Two main areas have been selected for the VP in this project: intimate partner violence and suicide risk assessment. Both of these areas are of great significance to public health and have direct relevance to clinical care, especially in psychiatry. Specific objectives of the project include exploring the user experience of the VP, examining whether the VP contributes to increased knowledge and confidence in asking questions within the chosen focus area, studying students' experiences of using the VP, how it has influenced their work with patients after graduation, and finally, examining user patterns on the VP platform.

Previous research suggests that virtual patient cases can have positive effects on learning and engagement and may even be more effective than traditional education in improving clinical decision-making and critical thinking skills. VPs have been studied in various medical specialties, but there is a lack of knowledge specifically in psychiatry. In this project, researchers will evaluate the use of VPs in psychiatric training within medical, nursing, and psychology programs.

Overall purpose (for the whole project):

To investigate virtual patient cases (VP) as an interactive educational module for students in universities and colleges. The educational module will consist of three parts: a theoretical and preparatory lecture, training with VP, and a follow-up seminar. The aim is to evaluate how well this module prepares students to ask clinically relevant questions in focus areas such as intimate partner violence and suicide risk assessment. The target group for the project is students in nursing, medical, and psychology programs at various universities and colleges in Sweden.

Specific aims for this study:

To investigate whether VP contributes to an increased level of knowledge and confidence in asking questions within the selected focus areas among students in nursing, medical, and psychology programs.

Focus areas for VP:

Intimate partner violence

Eligibility Criteria:
Inclusion Criteria:

\* Students in Nursing Program

Exclusion Criteria:

\* None, except if the student does not want to participate
Extension to a Study on the Efficacy and Safety of Vildagliptin in Combination With Pioglitazone in Patients With Type 2 Diabetes

Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a single oral drug. This is a 28-week extension to a study to assess the safety and effectiveness of vildagliptin, an unapproved drug, in lowering overall blood glucose levels when added to pioglitazone in people with type 2 diabetes not at target blood glucose levels on pioglitazone or rosiglitazone alone. The purpose of the extension study is to gather data on the long-term safety and effectiveness of vildagliptin in people with type 2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Only patients successfully completing study CLAF237A2304 are eligible
* Written informed consent
* Ability to comply with all study requirements

Exclusion Criteria:

* Premature discontinuation from study CLAF237A2304
* Other protocol-defined exclusion criteria may apply
Effect of Remazolam Besylate Combined With Remifentanil Analgesic Sedation on the Prognosis of Patients With Sepsis

In this study, midazolam was used as a control to investigate the effect of remazolam besylate combined with remifentanil on analgesia and sedation in patients with mechanical ventilation of sepsis on the prognosis of patients, and to provide evidence for the safe application of remazolam besylate in patients with sepsis.


Eligibility Criteria:
Inclusion Criteria:

1. Mechanical ventilation patients with sepsis who are expected to stay in ICU for ≥48h;
2. The condition was allowed to remain in shallow sedation (RASS-2 \~0);
3. Obtain informed consent from patients or family members

Exclusion Criteria:

1. pregnancy or breastfeeding;
2. General anesthesia surgery within 48 hours;
3. Severe, pre-existing parenchymatous liver disease with clinically significant portal hypertension, Child-Pugh grade C cirrhosis or acute liver failure;
4. Patients with acute and chronic renal insufficiency requiring dialysis treatment;
5. Severe craniocerebral injury, brain tumor, increased intracranial pressure, cerebrovascular accident, coma, epileptic status, etc. 6 Medical Ethics Committee of the First Affiliated Hospital of Ningbo University;
6. Patients with a history of alcohol or drug abuse;
7. Any condition that prevents the correct assessment of cognitive function, such as speech and sensory disorders or mental disorders (language difficulties or organic mental dysfunction);
8. Failure to obtain informed consent or authorization;
9. Participate in other exploratory clinical trials within 6 months prior to screening;
10. Known or suspected allergy to the study drug.
Strength on Wheels: A Meal Delivery and Exercise Intervention for Homebound Older Adults

The purpose of this study is to implement a home-based exercise program, administered through Interfaith Ministries of Greater Houston Meals on Wheels (MOWGH), and evaluate its effects on frailty status and nutritional markers in homebound older adults.


Eligibility Criteria:
Inclusion Criteria:

* enrolled in UT-Health Harris Health House Call Program (HCP)
* Frail or pre frail by FFP
* medically stable

Exclusion Criteria:

* robust by FFP
* Mini-Cog score \<3 and/or are unable to follow instructions
* pre-diagnosed terminal illness
* unable to ambulate,and/or are unable to use their upper extremities
Comparison of Self- and Balloon-expandable Valves in Patients With Ascending Aortic Dilation Undergoing Transcatheter Aortic Valve Replacement: The AAD-CHOICE

This study aimed at comparing the performance of self-expandable valves versus balloon-expandable valves in patients with ascending aortic dilation undergoing transcatheter aortic valve replacement.

Ascending aortic (AA) dilation is a common feature in patients with aortic stenosis (AS), especially in those with bicuspid aortic valve (BAV). For patients undergoing surgical aortic valve replacement (SAVR), current guidelines recommend concomitant aortic repair or replacement if the diameter of AA exceeds 45mm to avoid aortic dissection or rupture.

Transcatheter aortic valve replacement (TAVR) has profoundly changed the clinical management of AS patients who cannot tolerate SAVR. For patients who are candidates for TAVR, simultaneous repair of a dilated AA can be technically difficult. The safety and feasibility of the procedure and the fate of AA after the procedure in these patients remain unclear. Moreover, there are limited data comparing the performance of self-expandable valves versus balloon-expandable valves in these patients. The aim of the present study is to evaluate the impact of type of transcatheter heart valves on intra-procedural device success and post-procedural AA progression in patients with dilated AA (≥45mm) undergoing TAVR.

Eligibility Criteria:
Inclusion Criteria:

* Severe aortic stenosis;
* Transfemoral access;
* Preoperative aortic CT suggesting maximum ascending aortic diameter ≥45mm and \<55mm;
* Anticipated life expectancy \>1 year;
* Age ≥ 65 years.

Exclusion Criteria:

* Dominant aortic regurgitation,;
* A history of SAVR or TAVR;
* A history of aortic surgery;
* Emergent TAVR.
Safety and Effectiveness of Transdermal Buprenorphine in Cancer Pain

Buprenorphine transdermal patch is newly available in Taiwan in June 2017, the trade name is Transtec, and the available dosages are 35 μg/h and 52.5 μg/h. Taiwan is the first Asia country which launched Transtec for cancer pain treatment. Although the efficacy of transdermal buprenorphine has been demonstrated in some randomized, placebo-controlled studies and also conducted a large scale post-marketing surveillance study in Germany, therefore the local scientific data is required for Asia experience. Due to above rationale, this observational study will be initiated in Taiwan, to build up the first real-world scientific data in Asia.

The objective of this study is to collect the safety and effectiveness of transdermal buprenorphine in routine clinical practice, in particular, to collect data in population with controlled cancer pain and stable titration from previous opioid analgesics in Taiwan.

The objective of this observational study is to collect effectiveness and safety data on the labelled use of buprenorphine transdermal patches (Transtec 35 μg/h and 52.5 μg/h) under regular and routine clinical conditions in Taiwan for cancer patients with moderate to severe cancer pain (NRS Score\>=4) and strong opioids are needed for their pain treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Cancer patients aged 20 years old and over
2. ECOG \<3
3. Moderate or severe pain intensity with stable titration from previous opioid analgesics, 7 days at least prior to enrolment and with the dose equivalent to oral morphine ranging from 60 to 120 mg/day in previous treatment
4. Cancer-related pain that requires treatment with continuous around-the-clock strong opioid analgesic
5. Patients who are going to start Transtec treatment per clinical judgment, according to the locally approved labeling, are eligible.
6. Patients who are able to communicate and fill out the questionnaire forms
7. Patient provided signed informed consent

Exclusion Criteria:

1. Patients diagnosed with non-cancer pain or unexplained pain
2. Patients who have constipation (CTCAE grade 3 and above)
3. Patients with uncontrolled or unstable cardiac disease
4. Abnormal lab results, with obvious clinical significance, such as ALT or AST\>= 3 fold of upper limit of normal value or liver function of Child C grade prior to study
5. ALT or AST \>= 5 fold of upper limit of normal value for patients with liver metastasis or primary liver cancer
6. Pregnant or nursing (lactating) women
7. Patients who are drug or alcohol abuse
8. Patients who have hypersensitivity to buprenorphine
9. Patients who are clinically unstable or have a life expectancy of less than 8 weeks making completion of the trial unlikely
10. With any contraindications or using prohibited medication per locally approved