cyrilzakka/clinical-trials huggingface dataset:
Improving Asthma Communication in Minority Families

The purpose of this study is to determine if teaching children with asthma how to talk to their doctor about controlling their asthma including symptom frequency in an asthma diary and medication use techniques, will result in less symptom and missed school days, fewer emergency room visits and reduce the cost of asthma health care.

Children with persistent asthma are often not receiving regular preventive asthma care despite experiencing frequent asthma symptoms. When linked to timely and appropriate asthma medication use, good physician-parent-child communication is associated with a decrease in asthma morbidity and mortality. Removing obstacles to preventive asthma care and improving communication between the parent-children and PCP are two necessary prerequisites to improving asthma outcomes in low-income minority children.

We, the researchers at Johns Hopkins University, hypothesize that a culturally-tailored parent and child asthma communication intervention (ACI) designed to teach parent and child communication skills for use with their health care provider regarding asthma symptom severity, medication use, personal goal of treatment and quality of life issues will significantly reduce emergency room utilization for asthma care. We propose to compare this parent/child asthma communication intervention (ACI) to a developed standard asthma education intervention (SAE) designed to increase basic asthma self-management.

This study will advance nursing science by improving asthma self-management for school age children, who may be self-administering their asthma medications, yet not participate in receiving information or making their own medical decisions regarding their asthma. The proposed study is targeted at low-income minority school-aged children with evidence of poorly controlled, high-risk asthma. If successful, this intervention could have significant practical applications as a component of asthma nurse-case management, to practice currently being employed by many managed care groups across the country as an intervention for their high-risk/high ED use asthma patients. Because of the high prevalence and enormous health impact of asthma and the disproportionate asthma burden experienced by minority children, the outcome of the proposed study will have significant pediatric nursing applicability.

Eligibility Criteria:
Inclusion Criteria:

* Age 6-12 years
* Physician diagnosis of asthma
* Reside in metropolitan Baltimore
* English speaking
* Able to read 80% of parent educational brochure in English
* Emergency Department (ED) visit within the past 12 months and can identify a primary care provider
* No other co-morbid pulmonary disease

Exclusion Criteria:

* Enrolled in another asthma study
A Study to Assess the PK and Pharmacodynamics of IPX203 in Patients With Advanced Parkinson's Disease

This is a randomized, open-label, rater-blinded, multicenter, 3-treatment, 3 period, single-dose crossover study. Approximately 51 qualified immediate-release (IR) CD-LD-experienced advanced Parkinson's disease patients will be randomized to 1 of 3 dosing sequences.

Objectives:

* Assess the pharmacodynamics and pharmacokinetics (PK) of IPX203 (carbidopa and levodopa) in subjects with advanced Parkinson's disease.
* Characterize the safety of IPX203 in subjects with advanced Parkinson's disease.

IPX203 contains two different drugs called levodopa and carbidopa in one capsule.

* levodopa turns into a material called 'dopamine' in your brain. The dopamine helps to improve the symptoms of your Parkinson's disease.
* carbidopa belongs to a group of medicines called 'aromatic amino acid decarboxylase inhibitors'. It helps levodopa work more effectively by slowing the speed at which levodopa is broken down in your body.

Eligibility Criteria:
Inclusion Criteria:

Male or female subjects diagnosed with idiopathic PD with motor complications, who are currently being treated chronically with stable regimens of CD-LD.

Requiring at least 400 mg but not more than 1600 mg LD per day during the waking hours; and at least 100 mg but not more than 250 mg LD from IR CD-LD for the first morning dose.

Dosing frequency of IR CD-LD of at least 4 times daily excluding nighttime dosing.

Have an average of at least 2 hours per day "off" time during the waking hours and at least 1 hour "off" time per day, based on the PD diary collected for 3 consecutive days prior to Visit 1.

Exclusion criteria:

Have used first morning dose of controlled-release (CR) CD-LD or Rytary for at least 4 weeks prior to Visit 1.

Female subjects who are currently breastfeeding or lactating.

Had prior functional neurosurgical treatment for PD (ablation or deep brain stimulation) or if such procedure(s) are planned or anticipated during the study period.

Allergic to study drugs

History of medical conditions or of a prior surgical procedure that would interfere with LD absorption, such as gastrectomy or small-bowel resection.

History of peptic ulcer disease or upper gastrointestinal hemorrhage.

History of narrow angle glaucoma.

History of myocardial infarction with residual atrial, nodal, or ventricular arrhythmias; neuroleptic malignant syndrome; or nontraumatic rhabdomyolysis.

History of psychosis.

Employees or family members of the Investigator, study site, or Sponsor.

Subjects who, in the opinion of the clinical investigator, should not participate in the study.

Based on clinical assessment, subject does not adequately comprehend the terminology needed to complete the PD diary.
Determining the Relationship Between the Atherosclerosis and Periodontopathogenic Microorganisms

Determine the relationship between the systemic indications of atherosclerosis by means of the change in the ratio of periodontopathogenic microorganisms following periodontal treatment of individuals who have been diagnosed with chronic periodontitis-atherosclerosis and for individuals who have been diagnosed with systemically healthy-chronic periodontitis.

It has been aimed in this study to compare 1) the change in periodontal status; 2) the change of the periodontopathogen microorganisms (A. actinomycetemcomitans, P. gingivalis, T. forsythia, T. denticola, P. intermedia, P. micros, F. nucleatum/periodonticum, C. rectus, E. nodatum, E. corrodens, and C. gingivalis/ochracea/sputigena) in dental plaque samples, 3) the changes of the amounts of HDL, LDL, hs-CRP white blood cell levels (WBC), platelet levels (PLT), creatinine, and fibrinogen in serum samples; and 4) the correlation between periodontopathogen microorganisms (A. actinomycetemcomitans, P. gingivalis, T. forsythia, T. denticola, P. intermedia, P. micros, F. nucleatum/periodonticum, C. rectus, E. nodatum, E. corrodens, and C. gingivalis/ochracea/sputigena) and HDL, LDL, hs-CRP WBC, PLT, creatinine, and fibrinogen in patients that have been diagnosed with atherosclerosis-chronic periodontitis and systemic healthy patients and patients diagnosed with chronic periodontitis, following non surgical periodontal treatment.

Eligibility Criteria:
Inclusion Criteria:

* had no systemic disease,
* had not used any antibiotics
* had not used medications with an impact on the immune system,
* had not received any periodontal and/or medical treatment within the last 6 months.

Exclusion Criteria:

* smokers of cigarettes or other tobacco products,
* pregnant or breastfeeding,
* non-stable cardiovascular condition.
Blood Vessel Anatomy and Blood Flow Regulation

Brain blood flow regulation will be measured in response to environmental changes using MRI.

Global brain blood flow decreases with advancing age; however, some adults have accelerated declines in brain blood flow, placing them at a greater risk of cognitive impairment. Similarly, brain reactivity to increased levels of carbon dioxide decreases with age, with a greater decline in adults with vascular risk factors and is impaired in early Alzheimer's disease. Preclinical models suggest that reduced brain blood flow, results in low levels of oxygen regionally. Currently, there are a lack of human studies that investigate the cause or consequence of altered blood flow regulation in the brain.

The research aims are:

1. Determine the impact of vertebral artery hypoplasia (VAH) on brain reactivity to increased levels of carbon dioxide.
2. Determine the impact of VAH on the brain blood flow response to acute low levels of oxygen.

Eligibility Criteria:
Inclusion Criteria:

* BMI ≤38.5 kg/m2
* Nonsmoker
* Female subjects: postmenopausal
* Currently enrolled in the Wisconsin Alzheimer's Disease Research Clinical Core

Exclusion Criteria:

* Diagnosis of mild cognitive impairment or Alzheimer's disease
* Uncontrolled hypertension
* History or evidence of hepatic disease, hematological disease, or peripheral vascular disease
* Severe kidney injury requiring hemodialysis
* Cardiovascular disease including: severe congestive heart failure, coronary artery disease, ischemic heart disease (stents, coronary artery bypass grafts) and tachycardia
* History of clinically significant ischemic or hemorrhagic stroke, or significant cerebrovascular disease
* History of HIV/AIDS
* Severe untreated obstructive sleep apnea
* History of diabetes with HbA1c greater than 9.5%
* Major neurologic disorders other than dementia (e.g., multiple sclerosis, amyotrophic lateral sclerosis, brain surgery, etc.)
* Current or recent (\<1 year) major psychiatric condition (Axis I) or addictive disorders
* Contraindications to MRI
Tonsillectomy vs. Tonsillotomy in Adults With Obstructive Sleep Apnea

The primary purpose of this randomized controlled trial s to investigate whether surgical reduction of palatine tonsils (tonsillotomy) is a superior treatment compared to complete surgical removal of palatine tonsils (tonsillectomy) in adults patients with obstructive sleep apnea and concomitant enlarged tonsils in regards of perioperative and postoperative morbidity.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Tonsil size 2, 3, or 4 (Friedman tonsil scale)
* Confirmed OSA with sleep analysis not older than a year either CRM or PSG
* ASA 1 or 2
* BMI \< 35 kg/m2

Exclusion Criteria:

Children age \< 18 years

* Previous pharyngeal surgery such as previous tonsillotomy, tonsillectomy or palatal surgery
* Epileptic disease or severe neurological comorbidity.
* ASA 3, or 4.
* Central sleep apnea
* Previous thrombotic disease.
* Currently treated with sleep medications
* No collapse of oropharyngeal lateral wall during DISE
* Dropout of study, lack of sleep analysis or lack of postoperative DISE.
Medico-economic Study of the Subglottic Secretions Drainage in Prevention of Ventilator-associated Pneumonia (DEMETER)

In France, despite the implementation of bundles to prevent Ventilator-Associated Pneumonia (VAP) in the last decades, the VAP incidence remains high above 10 per cent. In the last american recommendations of VAP prevention, the drainage of subglottic secretions (SSD) has been notified among the "basic practices" to prevent VAP. Nevertheless, the diffusion of SSD in ICUs remains limited. This situation is largely due to the initial overcost of the specific endotracheal tubes allowing SSD and to the unavailability of these devices in medical units in which patients are intubated before the ICU admission. So, this pragmatical cluster randomized and cross-over study evaluates the medico-economic impact of the subglottic secretions drainage in addition to VAP prevention bundles in ICU.


Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years
* Invasive mechanical ventilation delivered via an endotracheal tube and expected to be required more than 24 hours
* Intubation performed in units in which the specific endotracheal tube allowing the subglottic secretions drainage (SSD) will be available during the SSD period of the trial
* Information delivered

Exclusion Criteria:

* Previous inclusion in the study
* Patients moribund at the ICU admission
* Pregnant, parturient or breast-feeding woman
* Patient hospitalized without consent and/or deprived of liberty by court's decision
* Patient under guardianship or curators
* Lack of social insurance
* Concomitant inclusion in a trial on VAP prevention
* Patient with no comprehension of the French language
Supervised Exercise, Sleep in Patients With Non Metastatic Breast Cancer

Insomnia affects about 60% of the patients treated with radio-chemotherapy, a percentage twice higher compared to that observed in the general population. This sleep disorder increases cancer-related fatigue (CRF), the side effect most often reported by patients. Conversely, it is well accepted that adapted physical activity (APA) improves tolerance to treatment, decreases the risk of recurrence, increases survival, and reduces CRF. The present study aims to evaluate, in non-metastatic breast cancer patients, the composition and architecture of sleep by ambulatory polysomnography and to verify the effects of an APA rehabilitation program (3 times a week during 12 weeks), on the quality and quantity of sleep, daytime sleepiness. The biological markers: melatonin and body temperature will be studied to better understand the chronobiological mechanisms of the sleep-wake rhythm. Finally, the physiological responses to exercise, pain, CRF and finally quality of life will be studied at the beginning, at the end of the program and at a distance from it. Improved sleep-wake rhythm by a physical activity may reduce CRF, prevent recurrence and comorbidities.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 to 65
* Patients with non-metastatic breast cancer undergoing chemotherapy
* Patients with insomnia
* Certificate of non-contraindication to the practice of physical activity
* Women who have been postmenopausal for at least 24 months, surgically sterilized, or, for women of childbearing potential, use an effective method of contraception (oral contraceptives, contraceptive injections, intrauterine devices, double-barrier method, contraceptive patches)
* Signature of informed consent to participate indicating that the subject has understood the purpose and procedures required by the study and that he agrees to participate in the study and to comply with the requirements and restrictions inherent in this study
* Affiliation to a French social security scheme or beneficiary of such a scheme.

Exclusion Criteria:

* Patients treated with melatonin or taking hypnotics
* Patients with metastases
* Oxygen saturation at rest (SaO2) ≤ 92%
* Patients without insomnia and / or sleep disorders
* Autoimmune disease (systemic lupus erythematosus, rheumatoid arthritis)
* Symptomatic osteoarthritis, cardiovascular disease (angina pectoris or uncontrolled hypertension) or lung disease (chronic obstructive pulmonary disease)
* Patients suffering from malnutrition (BMI \<18 kg.m-2) or weight loss\> 10% during the previous 3 months
* Patients with psychiatric or cognitive disorders deemed unsuitable for physical activity
* Pregnant or breastfeeding women
* Legal incapacity or limited legal capacity
* Subject unlikely to cooperate with the study and / or weak cooperation anticipated by the investigator
* Subject without health insurance
* Subject being in the period of exclusion from another study or provided for by the "national file of volunteers".
A Study of Poziotinib in Combination With T-DM1 in HER2-Positive Breast Cancer

This is a Phase 1b, open-label, multicenter study to determine the Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of poziotinib when administered with standard dosing of T-DM1 (3.6 mg/kg IV on Day 1 of each 21-day cycle) in women with advanced or metastatic HER2+ breast cancer. The poziotinib dose identified in Part 1 of the study will be used in combination with standard dose of T-DM1 in Part 2 of the study to confirm the poziotinib dose and evaluate the preliminary efficacy of the combination therapy.

In Part 1, the dose of poziotinib, in combination with the standard dose of T-DM1 (3.6 mg/kg IV) on Day 1 of each cycle will be determined using a "3+3" design with up to 3 dose levels tested beginning with 8 mg/day.

Poziotinib dose escalation/de-escalation for the next dose cohort will proceed based on the occurrence of dose-limiting toxicities (DLTs) during Cycle 1 of the dose cohort. Patients in the dose cohort, if not discontinued, will continue treatment until discontinuation.

In Part 2 of the study, approximately 10 patients will be treated at the MTD/MAD to confirm dose for safety of the combination and to evaluate preliminary efficacy. Treatment for all patients will continue until disease progression, unacceptable toxicity, or continuation of study treatment is not in the best interest of the patient.

The Screening period (Day -30 to Day -1) will last up to 30 days prior to Cycle 1, Day 1.

During each 21-day cycle, eligible patients will receive poziotinib at the assigned dose, orally, once daily. T-DM1 3.6 mg/kg IV will be administered on Day 1 of each treatment cycle.

All treated patients will be followed for response until disease progression or the start of new treatment and then for survival (3 year study duration).

Eligibility Criteria:
Inclusion Criteria:

* Patient must be female, at least 18 years of age, but not older than 90 years, with advanced or metastatic HER2+ breast cancer and a life expectancy of more than 6 months
* Patient must have confirmed HER2 overexpression or gene-amplified tumor via immunohistochemistry \[IHC\] with IHC 3+ or IHC 2+ with confirmatory fluorescence in situ hybridization \[FISH\]+ or \[ISH\]+
* Patients must have had at least 1 line of anti-HER2 directed therapy either in the metastatic or early-stage disease setting
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Exclusion Criteria:

* Patient has had previous treatment with poziotinib.
* Patient has received anticancer chemotherapy, TKIs, biologics, immunotherapy, radiotherapy, or investigational treatment within 15 days. (There is no washout for hormonal therapy for breast cancer).
* Patient has a life expectancy less than 3 years due to other malignancies.
* Patient is pregnant or breast-feeding.
A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of FIAsp in Subjects With Type 1 Diabetes

This trial is conducted in Europe. The aim of the trial is to investigate the pharmacokinetic (the exposure of the trial drug in the body) and pharmacodynamic (the effect of the investigated drug on the body) properties of FIAsp (faster-acting insulin aspart) in subjects with type 1 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months
* Body mass index 18.5-28.0 kg/m\^2 (both inclusive)

Exclusion Criteria:

* Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
* Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)
* Not able or willing to refrain from smoking and use of nicotine substitute products during the inpatient period inpatient period
Dry Pleurodesis With Talcum and Afatinib is Used to Treat Patients With Non-Small Cell Lung Carcinoma

In non-small cell lung cancer and metastases in the pleural cavity, pathological effusion is formed.

Currently, the most common and effective method of obliteration of the pleural cavity is pleurodesis with talcum powder.

Talc, when it surface of the pleura, causes chemical inflammation that leads to the soldering of the lungs and chest wall. As a result, the liquid ceases to accumulate.

The addition of a therapeutic dose of afatinib to talc not only blocks effusion into the pleural cavity, but also reduces tumor and metastatic processes.

The proposed procedure for dry pleurodesis consists of one stage.

Talc is introduced into the pleural cavity in several ways:

* Drainage - a tube is inserted into the pleural cavity through a puncture in the chest, and then a pasty talcum is delivered into the cavity, which spreads through the cavity during the change of the patient's body position.
* Talcum powder - under the control of thoracoscopy, dry talc is blown into the pleural cavity of the patient, which allows him to evenly distribute and significantly increases the effectiveness of the procedure.

In this Clinical Trial investigators will use the method of thoracoscopy - the blow in of talcum powder and therapeutic dose of Afatinib. Before injection, a suspension of talc and afatinib is subjected to the procedure of pharmaceutical mixing.

The operation is well tolerated by participants and lasts no more than 30 minutes. The effectiveness of the method is 90%.

Eligibility Criteria:
Inclusion Criteria:

* Non-small cell lung cancer with positive mutation of EGFR verified
* Malignant pleural effusion
* Recurrent pleural effusion
* Complete lung expansion (\> 80%) after puncture emptying confirmed by chest radiography.
* Karnofsky index \> 50
* Agreed to participate in the study and sign an Informed Consent

Exclusion Criteria:

* Radiotherapy not earlier than 3 months before the pleurodesis procedure
* Previous surgeries on the same hemitorace
* Thrombocytopenia or coagulation disorders
* Trapped lung syndrome
* Patients with estimated life expectancy \< 4-8 weeks
* Pleural or active systemic infection
Semaphorins 3A and 4D Levels in Heart Failure Patients

This study hypothesis is that Semaphorins 3A and 4D levels are overexpressed in patients with heart failure. Study protocol:

Hospitallized patients with new onset or previously diagnosed heart failure will be recruited to the study. Control group will include healthy people with no medical records or chronic treatment at the same age range. After signing an informed constent form, full medical history and blood samples will be collected. A second blood sample will be collected 8 weeks later, assuming the patient was discharged and not hospitalized since than. The blood samples will be analyzed by Bnai Zion Medical Center Immunology labs for the above semaphorins levels in the heart failure group and control group. Statistical analysis will then commence for possible correlatoion with different clinical parameters.

In few previous published studies, Semaphorins 3A levels are overexpressed in patients with heart failure. The aim of our study is the compare semaphorin 3A and 4D in patients with acute decompansated heart failure with healthy donors. Second aim is to compare semaphorin level in the same patients in time of hospitalization and few weeks later when the heart failure presumingly controled. Statistical analysis will then commense for possible correlatoion with different clinical parameters like NYHA (new york heart association) status of the patient, lenghts of hospitalization and BNP (brain natriuretic peptide) levels at time of admition.

Eligibility Criteria:
Inclusion Criteria:

* Patients with new onset or previously diagnosed heart failure.
* Heart failure diagnosis can be based on clinical judgment, echocardiography or elevated BNP levels

Exclusion Criteria:

* Patients with acute myocardial infarction diagnosed clinicly and labratory