cyrilzakka/clinical-trials huggingface dataset:
Identification of Genetic Causes of Calcific Aortic Valve Disease

This study aims to identify the molecular genetic causes of the variability in development of calcific aortic valve disease in bicuspid and tricuspid aortic valves and their associated aortic dilation.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a plan to undergo elective aortic valve replacement and/or ascending aortic surgery

Exclusion Criteria:

* Age \< 20 years
* Unable/unwilling to consent
* History of aortic valve replacement or transcatheter aortic valve replacement (TAVR)
* History of endocarditis
* History of rheumatic fever
* History of chest radiotherapy
* History of organ transplant
Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of AV411 in Neuropathic Pain

The purpose of this study is to determine the safety, tolerability and pharmacokinetics of AV411 after single and multiple doses in patients with chronic neuropathic pain due to diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of diabetic neuropathy or complex regional pain syndrome of at least 6 months duration
* VAS score of 4 cm or higher at Screening
* No clinical abnormality in laboratory and urine analyses
* Electrocardiogram within normal limits at Screening
* Negative pregnancy test on Study Day 1 for female subjects of childbearing potential
* On stable doses of medications, analgesic or others for at least 8 weeks prior to study enrollment
* Willing to use barrier contraceptive during the period of the study

Exclusion Criteria:

* Known hypersensitivity to AV411 or its components
* Conditions which might affect drug absorption, metabolism or excretion
* Untreated mental illness, current drug addiction or abuse or alcoholism
* Donated blood in the past 90 days or have poor peripheral venous access
* Platelets \<100,000mm3 or a history of thrombocytopenia
* Known or suspected chronic liver disease
* GFR \<=90mL/min/1.73m2 (Cockcroft-Gault)
* Female subjects who are pregnant or nursing mothers
* Received an investigational drug in the past 90 days
* Unable to swallow large capsules
Bevacizumab (Avastin) and Erlotinib (Tarceva) in Previously Treated Mesothelioma

The purpose of this study is to determine whether the combination of the investigational drugs Avastin and Tarceva are effective in patients with mesothelioma who have previously been treated with chemotherapy.

Each cycle of study treatment lasts 21 days. The patient will take erlotinib by mouth once daily. On day 1 of every cycle, the patient will receive bevacizumab intravenously over a 30-90 minute time period.

CT scan(s), MRI(s) and/or x-ray(s) of the cancer site will be performed every 6 weeks (2 cycles) to assess the extent of the response to treatment.

Bloodwork will be performed before the first dose of erlotinib and bevacizumab at Cycle 1, Cycle 2, Cycle 3, and at the end of treatment.

At the completion of the treatment a physical exam, vital signs, blood tests, urine tests and standard radiologic testing will be performed.

The duration of study depends upon how the patients' mesothelioma responds to treatment as well as how well the patient tolerates the medication.

Eligibility Criteria:
Inclusion Criteria:

* Mesothelioma that has been previously treated with at least one chemotherapy regimen
* 18 years of age or older
* Must at least be able to walk and capable of taking care of oneself although unable to carry out work activities
* Four or more weeks since last major surgery
* Four or more weeks since last radiation therapy
* Three or more weeks since last chemotherapy
* Life expectancy of 12 weeks or more
* Blood tests that show kidneys, liver and bone marrow to be working adequately
* Able to comply with study and/or follow-up procedures

Exclusion Criteria:

* Prior exposure to Tarceva (OSI-774, erlotinib), trastuzumab, ZD1839 or C225
* Receiving anticoagulation medication other than low dose Coumadin
* Clinically significant heart disease such as uncontrolled hypertension, previous heart attack within past 12 months, uneven heartbeat, etc.
* History of central nervous system disease such as seizures not controlled with standard medical therapy, brain metastases or history of stroke
* Major surgery within 28 days of screening
* Daily treatment with aspirin or anti-inflammatory medications
* Pregnant or lactating (pertaining to women only)
* Serious or nonhealing wound, ulcer or bone fracture
* Difficulty swallowing
* A disease or disorder that interferes with ability to digest and absorb food
* History of coughing up more than 1/4 teaspoon of blood
* A medical condition that could make it unsafe for patient to participate in this study
Modeling Genotype and Other Factors to Enhance the Safety of Coumadin Prescribing

The study goal is to conduct a randomized controlled trial to compare safety and accuracy of dosing based on clinical information including the clinical reason for your taking coumadin, your age, gender, your body surface area, and other medical conditions you may have with dosing estimated by a dosing calculator which adjusts for factors affecting coumadin dosing variability including genotypes for genes important in Coumadin metabolism and response. The hypothesis to be tested by this trial states that:when compared to patients managed with a best practices standard-of-care coumadin dosing regimen, patients randomized to coumadin dosing based on genetically programmed metabolic capacity and other known clinical and environmental factors affecting dose will: 1)show reduced risk of adverse events (using surrogate measures of such events); and 2)more rapidly achieve Coumadin dosing.

The study goal is to conduct a randomized controlled trial to compare safety and accuracy of dosing based on clinical information including clinical reason for taking coumadin, your age, gender, your body surface area, and other medical conditions you may have and dosing with dosing estimated by a dosing calculator which adjusts for factors affecting coumadin dosing variability including genotypes for genes important in Coumadin metabolism and response. The hypothesis to be tested by this trial states that:when compared to patients managed with a best practices standard-of-care coumadin dosing regimen, patients randomized to coumadin dosing based on genetically programmed metabolic capacity and other known clinical and environmental factors affecting dose will: 1)show reduced risk of adverse events (using surrogate measures of such events); and 2)more rapidly achieve Coumadin dosing

Eligibility Criteria:
Inclusion Criteria:

* Caucasian male and female patients(including Hispanic white) greater than or equal to 40 years of age;
* Patients initiating coumadin therapy without a documented history of stabilized dose of coumadin therapy;
* Target INR of 2 to 3.5;
* Women of childbearing potential must use an effective method of birth control(e.g. condom,oral contraceptives, indwelling intrauterine device, abstinence.

Exclusion Criteria:

* Age less than 40 years;
* Patients of known Native American, Asian, or African descent;
* Patients with thrombocytopenia(platelet count\<50x10 cells/ml);
* Patient has previously received coumadin and information on dosing of the patient is known at time of restarting coumadin;
* Patients with severe to moderate hepatic insufficiency (AST or ALT less than 2x the upper limit of normal;
* Clinical contraindication for coumadin therapy;
* Female patients with a positive pregnancy test or women who are breastfeeding
Effect of a Family Empowerment Program on Coping, Problem Solving in Parents, and Quality of Life in Children With Cystic Fibrosis

Parents of children with cystic fibrosis (CF) experience high levels of stress and problems. Family empowerment interventions provide important support for many patients with CF and their families. However,there is a lack of research exploring the effects of such empowerment programs on coping, and Problem Solving among parents, and Quality of Life in Children with CF.

The present study aimed to assess the effect of a family empowerment program-based nursing intervention on parents coping with stress and problem solving, and quality of life children with CF.

Parents of children with cystic fibrosis (CF) experience high levels of stress and problems. Family empowerment interventions provide important support for many patients with CF and their families. However,there is a lack of research exploring the effects of such empowerment programs on coping, and Problem Solving among parents, and Quality of Life in Children with CF. The present study aimed to assess the effect of a family empowerment program-based nursing intervention on parents coping with stress and problem solving, and quality of life children with CF.

A single-blinded, parallel group pretest and posttest design randomized controlled trial was used.

Data were collected over 5 months (January 2017-May 2017) from 48 participants in a medical faculty hospital. They were randomly assigned to the experimental (n = 24) and control (n = 24) groups. Nursing interventions applied to the experimental group for ten weeks with the intent of strengthening families consist of; providing individualized training and booklet concerning disease management and providing phone calls and consultancy services for the purpose of reinforcing the training and increasing the motivation. A routine polyclinic follow-up was applied to the control group. Problem Solving Inventory (PSI), Scale of Ways of Coping with Stress (SWCS), and The Cystic Fibrosis Questionnaire-Revised scale (CFQ-R) were used reliable and valid instruments. The data were evaluated using the Wilcoxon Signed Ranks test in evaluating dependent groups and the Mann-Whitney U test in independent groups.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 6-18 years old;
* Pulmonary functions Forced Expiratory Volume (FEV 1) over 40%
* being able to communicate in Turkish,
* voluntary parents in the study.

Exclusion Criteria:

* had mental disorders;
* receiving mechanical ventilation;
* Being in the process of lung transplantation;
* having a sister/brother who died due to CF
* Being in enteral or parenteral feeding;
* having a chronic disease other than CF.
Effects of Community-center Based Dietary Intervention on Frailty Prevention and Regression in the Elderly.

Recent interventional studies have shown that frailty can be improved by modifying dietary quality. In this study, a set of nutrition-centric health promotion activities was developed in accordance with the Taiwanese Daily Food Guide for elderly participants of the community centers to improve their nutrition in everyday practice and examined the efficacy of these activities on slowing down the development or regression of frailty. The study was a cluster-randomized controlled trial. Recruited community centers were randomly assigned into either the control or the intervention group. The intervention period lasted for 3 months. Both the control and intervention groups received weekly one-hour group exercise training. The intervention group had an additional weekly one-hour group nutrition session. The intervention programs included: (a) training on-site staffs to use motivational interview techniques to communicate, to estimate participant's energy requirements, and to learn how to provide proper amounts of foods to individual elderlies, (b) nutrition grouped activities on ①know my plate, ②wholegrains, ③drinking teas with dairy, and nuts, ④novel ways to eat fruit and vegetables, ⑤healthy breakfast ideas. In the first month, participants were intervened with the activities laid out above; in the second month, participants were intervened with qualitative discussions on dietary changes; in the third month, participants were intervened with designed activities that helped break down barriers in order to establish a long-term change in dietary habits. Improvement in nutritional status was the primary outcome. Secondary outcomes included frailty scores, physical performance, and mental health. The measurements were performed at baseline, 3 months, and 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Aged 65 years or older
* Able to walk independently for 14 meters within 1 minute
* Willing to sign the informed consent

Exclusion Criteria:

* Under dietary control by doctors' instructions
* With mental illness, mental disorders, or unable to communicate
* With severe diseases such as under treatments for cancer
A Study of Emicizumab Administered Subcutaneously (SC) in Pediatric Participants With Hemophilia A and Factor VIII (FVIII) Inhibitors

This non-randomized, multicenter, open-label, Phase III clinical study will evaluate the efficacy, safety, and pharmacokinetics of emicizumab administered subcutaneously initially once weekly (QW) in pediatric participants with hemophilia A with FVIII inhibitors. This study will open two additional non-randomized cohorts to investigate once every 2 weeks (Q2W) and once every 4 weeks (Q4W) regimens in pediatric participants.


Eligibility Criteria:
Inclusion Criteria:

* Children less than (\<) 12 years of age, with allowance for participants 12 to 17 years of age who weigh \<40 kilograms (kg) (Cohort A only); and participants \<2 years of age will be allowed to participate only after the protocol-defined interim data review criteria are met (Cohort A only)
* Diagnosis of congenital hemophilia A of any severity and documented history of high-titer inhibitor (that is \[i.e.\], greater than or equal to \[\>/=\] 5 bethesda units \[BU\])
* Requires treatment with bypassing agents
* Adequate hematologic, hepatic, and renal function

Exclusion Criteria:

* Inherited or acquired bleeding disorder other than hemophilia A
* Ongoing (or planning to receive during the study) immune tolerance induction (ITI) therapy or prophylaxis treatment with FVIII
* Previous (in the past 12 months) or current treatment for thromboembolic disease or signs of thromboembolic disease
* Other disease that may increase risk of bleeding or thrombosis
* History of clinically significant hypersensitivity associated with monoclonal antibody therapy or components of the emicizumab injection
* Known infection with human immunodeficiency virus (HIV) or hepatitis B or C virus
* Use of systemic immunomodulators at enrollment or planned use during the study period
* Planned surgery (excluding minor procedures such as tooth extraction or incision and drainage) during the study
* Inability (or unwillingness by caregiver) to receive (allow receipt of) blood or blood products (or any standard-of-care treatment for a life-threatening condition)
* Participants who are at high risk for thrombotic microangiopathy (TMA) (e.g., have a previous medical or family history of TMA), in the investigator's judgement
Theory Based Integrated Program on Medication Adherence Among Community Dwelling Schizophrenia

This clinical trial aims to evaluate the effectiveness of the theory-based integrated program in promoting medication adherence in patients with schizophrenia. The purpose of this study are:

* To explore the effectiveness of the theory-based integrated program in promoting community-based schizophrenia patients' adherence to medication(like :motivation, attitude and behavior)
* To explore the effectiveness of the theory-based integrated program in improving the psychiatric symptoms of patients with schizophrenia in the community.

Participants (the experimental group) received routine home visits from psychiatric mental nurses, including drug administration, drug side effects and symptom management, life care, and the theory-based program provided by the researcher(treatment as usual + the theory-based integrated program).

The comparison group: received routine home visits from psychiatric mental nurses, including drug administration, drug side effects, and symptom management, life care,(treatment as usual).

Members of the experimental group received routine home visits, plus a 1-hour the theory-based program intervention 12 times in the 1st, 3rd, 5th, 7th, 9th, 11th, 13th, 15th, 17th, 19th, 21st, and 23rd weeks, and each patient received a total of 12 hours of intervention.

The control group received routine home visits by psychiatric mental nurses, and the nurse provided patients with answers to questions about medications or care and handling of life events. The visits and intervention time frequency were the same as those in the experimental group.

Both groups were received baseline (T0), after the 6th hours intervention (T1) and 12th hours intervention by nurses to collect data on the main outcome variables: adherence to medication, mental symptoms, motivation to take medication, and attitude towards medication.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnosis of schizophrenia group, including schizophrenia, affective schizophrenia (schizoaffective disorder);
2. Age between 20 and 64 years old;
3. At least one oral antipsychotic drugs;
4. Living in the community, not participating in day wards, community rehabilitation centers and other rehabilitation institutions on weekdays, no psychiatric outpatient clinics, only home visits by home nurses;
5. Those who can communicate in Chinese and Taiwanese

Exclusion Criteria:

1. Those who have a diagnosis related to organic problems, substance abuse, dementia or mental retardation, and are unable to communicate;
2. Those who have received long-acting injections from the psychiatric department. -
High Flow Nasal Oxygen for Acute Hypoxemic Respiratory Failure in the Emergency Room

The aim of this multicenter, randomized, controlled, open-label trial is to investigate the efficacy of early treatment with HFNO compared with SOT in preventing early deterioration of patients admitted to the ER because of acute hypoxemic respiratory failure.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years;
* PaO2/FiO2 ratio between 250 and 150 mmHg or SpO2/FiO2 ratio between 190 and 274, after at least 15 minutes of spontaneous breathing through a Venturi mask (VM), with a FiO2 targeted at a SpO2 94-97%;
* Respiratory rate(RR)≤35breaths/min,afteratleast15minutesofspontaneous breathing through a VM, with a FiO2 targeted at a SpO2 94-97%;
* PaCO2 ≤ 45 mmHg;
* Unilateral or bilateral infiltrate(s), as detected with chest radiography and/or computed tomography and/or with lung ultrasound not fully explained by effusions, atelectasis, or nodules/masses. Infiltrates at lung ultrasound are defined as presence of focal B-lines, consolidations (with irregular marginal contour, air bronchogram, air trapping sign) and irregularity of the pleural line.

Exclusion Criteria:

* Respiratory failure due to:

  * Acute asthma or COPD exacerbation,
  * Cardiac failure or fluid overload as primary cause of respiratory failure;
* Unstable angina or ongoing acute myocardial infarction;
* Acute respiratory acidosis with pH \< 7.35 and PaCO2 \> 45 mmHg;
* Hemodynamic instability and/or use of vasopressors/inotropes;
* Altered mental status (Kelly \>3), see Figure 1;(18)
* Contraindications to NIV (high risk of aspiration pneumonia, impaired airways protection, head-facial trauma and/or burns, uncooperative patient, cranial/thoracic/abdominal open wounds);
* Indications to urgent intubation performed according to the clinician in charge;
* Body Mass Index \> 35 kg/m2;
* Pregnancy;
* Patient's refusal to participate.
Study Comparing Veliparib Plus Carboplatin and Paclitaxel Versus Placebo Plus Carboplatin and Paclitaxel in Previously Untreated Advanced or Metastatic Squamous Non-Small Cell Lung Cancer

The purpose of this study is to evaluate the safety and efficacy of the addition of veliparib plus carboplatin and paclitaxel versus the addition of placebo plus carboplatin and paclitaxel in adults with advanced or metastatic squamous non-small cell lung cancer (NSCLC).


Eligibility Criteria:
Inclusion Criteria:

1. Life expectancy \> 12 weeks
2. Subject must have cytologically or histologically confirmed squamous NSCLC.
3. Subject must have advanced or metastatic squamous NSCLC that is not amenable to surgical resection or radiation with curative intent at time of study Screening.
4. Subjects with recurrent squamous NSCLC after surgical treatment that is not amenable to surgical resection or radiation with curative intent are eligible.
5. Subject must have at least 1 unidimensional measurable NSCLC lesion on a computerized tomography (CT) scan as defined by Response Evaluation Criteria In Solid Tumors (RECIST - version 1.1).

Exclusion Criteria:

1. Subject has a known hypersensitivity to paclitaxel or to other drugs formulated with polyethoxylated castor oil (Cremophor).
2. Subject has a known hypersensitivity to platinum compounds.
3. Subject has peripheral neuropathy \>= grade 2.
4. Subject has non-squamous NSCLC, or a known epidermal growth factor receptor (EGFR) mutation of exon 19 deletion or L858R mutation in exon 21, or a known anaplastic lymphoma kinase (ALK) gene rearrangement.
5. Subject has received prior cytotoxic chemotherapy (including definitive chemoradiotherapy) for NSCLC, except for adjuvant or neoadjuvant therapy.
Hyperoxic Oxidative Stress During Abdominal Surgery

Our aim is to compare the effects of 80% and 40% Fraction of inspired oxygen on oxidative stress, antioxidant response (in plasma and bronchoalveolar lavage), extubation quality, preanesthetic and postanesthetic expiration tidal volumes.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing abdominal surgery, between 20-60 years old, with American Society of Anesthesiology score I or II

Exclusion Criteria:

* Patients with Chronic Obstructive Pulmonary Disease, Diabetes Mellitus, muscle-bone diseases, inflammatory bowel diseases and patients with malnutrition.

Patients will be recruited through general surgery service of our hospital
Biomechanics Based Prediction of Preterm Delivery

Quantitative information on the biomechanical properties of the ecto-cervix in mid-pregnancy will be compared between women with term vs. preterm delivery. We aim to demonstrate that biomechanical data (ASP and CCI) might complement morphological data (CL) to improve prediction of preterm delivery. It is expected that women with preterm delivery will show stronger weakening of cervical tissue. Aspiration (ASP) and cervical CCI (cervical consistency index) measurements are performed at mid-pregnancy: detection at this time point is useful for therapy and biomechanical modifications are already significant so to enable differentiation by biomechanical measurements (ASP and CCI).


Eligibility Criteria:
Inclusion Criteria:

* All pregnant women presenting at their mid pregnancy consultation (18+0 - 22+0 weeks of pregnancy) are eligible
* Signed informed consent after being informed is a prerequisite for enrollment.

Exclusion Criteria:

* Communication problems
* Missing consent
* Age\<18
* Active bleeding / Premature Rupture of Membranes (PROM)
* Active genital infection
* Known carrier of HIV or Hepatitis B or C
* Placenta praevia
* Müllerian anomalies
* known or suspected non-compliance, drug or alcohol abuse
* cerclage
* use of pessary