cyrilzakka/clinical-trials huggingface dataset:
Assesment of the Effectiveness of High Frequency Oral Oscillation and Mask of PEP in Children With Pneumonia

The hypothesis of this study is that the physiologic effects of these (PEP/ HFOO) resources may have positive effects in this population of children with acute respiratory illness.

Thinking about this physical and physiological issue and due to the absence of a study that has evaluated the effectiveness of these instruments in patients with pneumonia, the objective of this study is to evaluate the short-term effects OOAF and mask of EPAP in children hospitalized for community-acquired pneumonia.

The pneumonia is characterized by an acute infectious and inflammatory process, usually compromises the alveoli, bronchioles and interstitial space difficulting hematosis and may be in some or all of the cells filled with liquid and blood cells. The accumulation of secretion occurs as a consequence of this infectious and inflammatory process and contributes to clinical worsening by increasing airway resistance.

Respiratory physiotherapy has been questioned in patients with pneumonia and recent clinical studies have shown that there is no benefit to these patients. Respiratory physical therapy in addition to manual techniques has in his repertoire instrumental resources such as therapeutic high-frequency oral oscillator (HFOO) and the mask of expiratory positive pressure (PEP). The hypothesis of this study is that physical and physiological effects of these resources may have positive effects in this population of children with acute respiratory illness. The aim of this study is to evaluate the short-term effects HFOO and mask of PEP in children hospitalized for community-acquired pneumonia.

Eligibility Criteria:
Inclusion Criteria:

* age between 03 and 11 years old;
* have Pneumonia diagnosis done by a physician pediatrician (1) presence of cough and/or fever; (2) tachypnea according to age group (1-5 years-40 bpm; 5 years -30 bpm); (3) radiological change with consolidation or infiltrators associated or not with other findings compatible with pneumonia. All films will be evaluated by a radiologist and a pediatrician

Exclusion Criteria:

* chronic neurological Disease, or respiratory arrest
* failure to collaborate with therapy or assessment
* need of invasive or non-invasive ventilatory assistance
* hemodynamic instability
* vomiting or nausea
* not drained Pneumothorax
* not drained extensive pleural effusion
* dyspnea
* do not agree with research
My-HyperCVAD in the Treatment of Relapsed Refractory Adult Acute Lymphoid Leukemia

The patient receive 2 different drug combinations on this study. The first combination will consist of an intensive chemotherapy regimen (cyclophosphamide, mesna, methotrexate, doxorubicin liposomal or doxorubicin, vincristine, ARA-C (cytarabine) and dexamethasone). The second combination will consist of another intensive chemotherapy regimen (methotrexate and Ara-C \[cytarabine\]).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of ALL (any type included), in patients who:

  * have relapsed after conventional chemotherapy\* or,
  * are refractory to at least 1 cycle of chemotherapy\*
* ECOG Performance score of 0-3
* Adequate hepatic and renal function, as defined by serum transaminases \<2.5x ULN, bilirubin \<1.5xULN, and creatinine \<1.5x ULN.
* Age 18 years or greater.
* Documentation of written informed consent to participate in the trial.
* Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
* at least 3 weeks from prior chemotherapy or other investigational anticancer therapy with full recovery from prior toxicities.
* either men or women, accepting to practice effective contraception during the entire study period unless documentation of infertility exists.

Exclusion Criteria:

* Treatment with any investigational agent within 3 weeks prior to study therapy.
* Major surgeries within 4 weeks from study start or not fully recovered from any previous surgical procedure.
* Presence of any medical or psychiatric condition which may limit full compliance with the study or increase the risk associated with study participation or study drug administration, including but not limited to:

  * Presence of central nervous system (CNS) leukemia.
  * Active uncontrolled bacterial infection.
  * Known human immunodeficiency virus (HIV) infection.
  * Significant cardiovascular disease (i.e., uncontrolled arrhythmias, unstable angina), or a major thromboembolic event (myocardial infarction, stroke, transient ischemic attack, pulmonary embolism, or non-catheter-related deep-vein thrombosis) in the last 6 months.
  * Pregnancy or breast-feeding.
  * Malabsorption syndromes
German TAVI-Register

The TAVI - Register is a Germany-wide scientific elevation in which data about the aortic valve treatment and the therapeutic consequences are documented.

Documentation of all consecutive patients of the participating centers with significant aortic stenosis, undergoing one of the following therapies:

1. Percutaneous transfemoral aortic valve replacement
2. Percutaneous aortic valve replacement transapical
3. Percutaneous aortic valve replacement transaortic
4. Aortic valve balloon valvuloplasty
5. Surgical aortic valve replacement
6. Conservative treatment

   * Documentation of the indications, procedural results and clinical short-and long-term results of the above therapies
   * Documentation of operational risk and quality of life
   * Documentation of the technical implementation of the procedure and success of the intervention and of hospital reinterventions
   * Documentation of hospital mortality, nonfatal major complications (stroke, TIA, myocardial infarction, dialysis, vascular complications, bleeding, neuropsychological status)
   * Documentation of discharge medication and the length of hospital stay
   * Documentation of the serious long-term complications, including mortality, stroke, TIA, myocardial infarction, dialysis, the reintervention and quality of life and of drug therapy within 30 days, 1 year, 3 years and 5 years.

Eligibility Criteria:
Inclusion Criteria:

patients with aortic stenosis (degree III) who received one of the following therapies:

* transapical operative aortic valve implantation
* operative aortic valve implantation
* percutaneous aortic valve implantation
* balloon valvuloplasty

Exclusion Criteria:

* missing signed informed consent
The Prevalence, Disease Burden and Prognosis of COPD in Patients With Cardiovascular Diseases

This is a multi-center, prospective, and interventional study conducted in 3 types of cardiovascular diseases (CVD) subjects , including 3 cohorts which are patients with newly or previously diagnosed coronary heart disease ( CHD), atrial fibrillation ( AF) and chronic heart failure (CHF).

The mainly purpose of this study is describe the prevalence of COPD of the subjects with 3 types of CVD who are aged 40 years or older, and also observe the effect of cardiopulmonary co management on the short term prognosis of subjects with CVD and COPD.

This study will enroll approximately 3,000 subjects, with approximately 1,000 subjects in each cohort.

Eligibility Criteria:
Inclusion Criteria:

1. Give signed written informed consent to participate.
2. At least 40 years of age at baseline visit.
3. Previous or newly diagnosed by at least one of the 3 types of CVD which are,

   * Coronary heart disease ( CHD )
   * Atrial fibrillation (AF )
   * Chronic heart failure ( CHF )
4. Subjects have no absolute contraindications to spirometry testing.
5. Subjects have the cognitive ability to conduct questionnaires after e valuated by investigators.

Exclusion Criteria:

1. Significant diseases or conditions, which, in the opinion of the investigator, may put the subject at risk because of participation in the study or may influence either the results of the study or the subject's ability to participate in the study.
2. Women who are pregnant or lactating or are planning to become pregnant, or women of childbearing potential who are not using an acceptable method of contraception.
3. Subjects who are not able to provide written informed consent.
4. Treatment with investigational study drug or device in another clinical study within the last 30 days or five half lives prior to baseline visit , whichever is longer.
Using Baby Books to Promote Maternal and Child Health

The Baby Books Project tests whether embedding educational information into baby books can improve the health and wellbeing of first-time mothers and their young children.

This study tests the efficacy of embedding educational information (i.e., pediatric anticipatory guidance) into baby books that first-time mothers read to their infants. This 3-group longitudinal study recruited first-time mothers in their third trimester of pregnancy, randomly assigned them to conditions, and followed them until the child was 18 months of age. One group received educational baby books, another group was given the same illustrated books with non-educational text, and the third group was not given any books. Thus, the effects of educational reading could be parsed from the effects of reading alone. The study aimed to test whether embedding pediatric anticipatory guidance in picture books is an effective method for increasing maternal knowledge of child development, parenting strategies, and safety practices, improving parenting beliefs and attitudes (e.g., parenting efficacy, importance of reading, use of corporal punishment), supporting optimal parenting practices (e.g., breastfeeding and nutrition, responsiveness, safety practices), improving maternal health (stress, depression), and supporting children's healthier development (injuries, illness, immunizations, and linguistic, social, and cognitive development).

Survey and observational data collection occurred in participants' homes during their third trimester of pregnancy and when their child was 2, 4, 6, 9, 12, and 18 months of age. Twelve phone call interviews were conducted between these home visits. When children were 18 months, a retrospective medical chart audit was conducted.

Eligibility Criteria:
Inclusion Criteria:

* Women who are pregnant with first child and able to read in English at a first grade reading level

Exclusion Criteria:

* Women with other children, men, those not able to read in English at a first grade level
Quality of Life in Patients With Clinically Localized Prostate Cancer Treated With Radiosurgery

Quality of life data following SBRT for prostate cancer has been obtained in only a small numbers of patients. A prospective study using validated quality of life questionnaires is needed to determine outcomes after treatment with SBRT. Our study will be the first essential step in developing a better evidence base on the comparative risks and benefits of SBRT treatment with regards to quality of life assessment and outcomes.

Study Design (for example, hypothesis, research question, standard and experimental procedures, special or unusual equipment or procedures):

The main goal of this study is to evaluate quality of life outcomes and changes in patient reported symptoms (e.g. urinary, bowel and sexual function) in patients receiving SBRT treatment for clinically localized prostate cancer. Validated quality of life questionnaires will be administered in a deidentified, prospective fashion. Eligible subjects will be patients undergoing SBRT treatment for prostate cancer.

Hypothesis: Patients undergoing SBRT will have similar cancer control and symptoms as men who are treated with other radiation therapy modalities.

Primary objective: To evaluate quality of life outcomes (e.g. fatigue, urinary, bowel and sexual function) for patients with clinically localized prostate cancer treated with SBRT.

Secondary objectives: Prospective data on cancer control and toxicity following SBRT for clinically localized prostate cancer.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed adenocarcinoma of prostate
* Signed study-specific consent
* Prostate Specific Antigen (PSA) within 60 days of registration

Exclusion Criteria:

* Prior pelvic radiotherapy
* Prior radical prostate surgery
* Medical or psychiatric illness that would interfere with treatment or follow up
* Implanted hardware adjacent to the prostate that would prohibit appropriate treatment planning and/or treatment delivery
Comparison of Skin Prick Testing and Intradermal Skin Test Result of Local and Imported Insect Allergen Extracts

Comparison the results of skin prick testing and Intradermal skin test result of local and imported insect allergen extracts in patients with serious insect sting allergy reactions

The patients with serious insect sting allergy reactions were evaluated and skin prick test and intradermal test with local and imported insect allergen extracts were performed. Specific IgE for insects was also performed. The results of skin prick testing and Intradermal skin test of local and imported insect allergen extracts were compared. The results also compared with specific IgE to insects

Eligibility Criteria:
Inclusion Criteria:

* Patients with severe insect allergy reaction
* Allow being done skin test and blood foe specific IgE

Exclusion Criteria:

* Serious systemic diseases
* severe asthma
* pregnant or nursing
* severe and extended skin lesion
Semi-Quantification of Her2/Neu Protein Expression in Formalin Fixed, Paraffin-Embedded Normal and Neoplastic Tissue

The purpose of the study is the identification and quantification of protein expression level in breast cancer tissues.

The imaging system is intended for diagnostic use as an aid to the pathologist in the detection, counting and classifying her2 immunohistochemical (IHC) stained samples.

The anti Her2/neu Kit is a semi-quantitative immunohistochemical (IHC) assay to identify the Human Epithelial growth factor receptor (Her2/neu) expression in formalin-fixed, paraffin-embedded human breast cancer tissue specimens. Results from the Her-2 test is indicated as an aid in the assessment of patients for whom HERCEPTIN® (Trastuzumab) treatment is being considered. While the Her-2 kit provides the antibodies that offer direct visualization and semi-quantification of the HER2 protein expression through a brightfield microscope, the GenASIs GoPath system is designed to complement the routine workflow of the pathologist in the review of immunohistochemically stained histologic slides.

Eligibility Criteria:
Inclusion Criteria:

* Women having breast cancer aged 21 and up
* Borders of tumor nuclei are distinguishable
* Nuclei should have good integrity
* Background should not contain particles that interfere with the analysis

Exclusion Criteria:

* Slides that cannot be analyzed manually by Pathologist
Evaluating Image Quality and Comfort of an Investigational Curved Paddle Compared to a Standard Paddle

The goal of this study is to evaluate patient comfort during compression with a standard flat mammographic paddle and an investigational curved paddle. This is a study that will be performed with x-ray imaging and will be used to determine if an overall reduction in pain can be appreciated in patients without loss in image quality as compared to the current standard mammogram. Another benefit of the curved paddle may be an increase of perceivable and measurable tissue capture.

The study will be conducted in the United States at up to 5 centers. The study will enroll up to 600 subjects. The number of subjects was chosen to allow evaluation of screening and diagnostic patients with a variety of breast densities (fatty, scattered densities, heterogeneously dense or extremely dense) and women with a range of breasts sizes that fit on the current detector. The evaluation of pain reduction will be the primary endpoint, while examining the potential of increased tissue capture without a compromise in image quality will be assessed as secondary endpoints. The enrollment will be consecutive for subjects who sign informed consent to participate. Women participating in the study will present for a screening or diagnostic imaging exam.

Eligibility Criteria:
Inclusion Criteria:

* Subject is female of any race and ethnicity
* Screening Subject is at least 40 years old, Diagnostic subjects are at least 25 years old
* Subject will be referred for a screening or a diagnostic work-up with tomosynthesis as part of the exam

Exclusion Criteria:

* Subjects who are pregnant or who think they may be pregnant
* Subjects lactating or presenting with discharge
* Women too large for the detector
* Subjects who cannot give informed consent
Comparison Between GnRH Agonist and GnRH Antagonist Protocols of Ovarian Stimulation in PCOS Patients

The purpose of this study is to compare pregnancy rates and the occurrence of OHSS in PCOS patients who were treated with GnRH agonist and GnRH antagonist protocols ovarian stimulation during an IVF cycle. Our hypothesis is that the GnRH antagonist protocol reduces the occurrence and severity of OHSS compared to the GnRH agonist protocol.

Women with polycystic ovarian syndrome (PCOS) represent a group of patients at high risk of developing ovarian hyperstimulation syndrome (OHSS), an iatrogenic complication of ovarian stimulation during IVF treatment. In contrast to mild OHSS, severe OHSS is a life-threatening complication, characterized by massive ovarian enlargement, ascites, pleural effusion, oliguria, haemoconcentration and thromboembolic phenomena. Currently, no curative therapy for OHSS is available and thus prevention is considered the most effective "treatment". Several measures have been adopted to reduce the occurrence of the syndrome, the most effective being cycle cancellation and withholding of human chorionic gonadotropin (hCG), which seems to be the most critical factor for the development of OHSS.

COMPARISON: This study aims to compare the development and severity of OHSS, as well as ongoing pregnancy rates in PCOS patients who received a flexible GnRH antagonist (Ganirelix) protocol vs a long GnRH agonist (Arvekap) protocol of ovarian stimulation.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of PCOS (presence of oligo-ovulation/anovulation and polycystic ovaries)

Exclusion Criteria:

* Normal responders
* Poor responders
Progressively Decreasing Titration Schedules of Bifeprunox in Subjects With Schizophrenia or Bipolar Disorder

This study is to assess the tolerability of bifeprunox with the progressive elimination of titration steps to achieve the shortest tolerated titration dosing to a dose of 40 mg/day in either schizophrenia or bipolar disorder subjects. Study duration is 2 months with an optional open-label 26-week extension study.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with the current Diagnosis of Schizophrenia, Bipolar Type I Disorder according to DSM-IV TR criteria
* Age 18 to 55
* Body weight 100-250 lbs
* Be sufficiently stable to allow discontinuation of antipsychotic medication

Exclusion Criteria:

* Acutely psychotic subjects
* Subjects that are acutely manic
* Subjects with a psych diagnosis other than Bipolar Type I Disorder
Safety and Tolerability of Repeat Doses of ACU-4429 in Healthy Subjects

The purpose of this study is to evaluate the safety and tolerability of repeated doses of a new investigational drug (ACU-4429) in healthy human subjects.


Eligibility Criteria:
Inclusion Criteria:

* males or females, between 25 and 55 years of age, inclusive
* within BMI range 19 to 32 kg/m2 at Screening
* in good health, determined by no clinically significant findings from medical history, 12-lead ECG, and vital signs;
* clinical laboratory evaluations (including serum for Chem-20 \[fasted at least 10 hours\], CBC with differential and platelet counts, PT, INR, and aPTT, and UA) within the reference range for the test laboratory, unless deemed not clinically significant by the Investigator;
* Males (or female partners of male subjects)and females must be sterile, or agree to use approved contraceptive measures throughout the study period and 45 days after the End of In House Study.
* able to comprehend and willing to sign an Informed Consent Form.

Exclusion Criteria:

* significant history or clinical manifestation of any significant metabolic, endocrine, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, or psychiatric disorder (as determined by the Investigator);
* history of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator;
* history of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs, except that appendectomy, hernia repair, and/or cholecystectomy will be allowed;
* history or presence of an abnormal ECG, which, in the Investigator's opinion, is clinically significant;
* participation in any other investigational study drug trial in which receipt of an investigational study drug occurred within 30 days prior to Check-in;
* Is currently using, or has recently received treatment with a medication disallowed by the Protocol.
Osteoporosis Among Men Treated With Androgen Deprivation for Prostate Cancer

The purpose of this study is

* to determine the rate of osteoporosis among patients with advanced prostate cancer.
* to propose an algorithm for early detection of patients with advanced prostate cancer who are at risk of developing osteoporosis.

Patients with advanced prostate cancer are included at the initiating of androgen deprivation therapy.

The patients are followed for 2 years after inclusion with blood sampling, DXA-scan, questionnaire, bone scintigraphy.

Eligibility Criteria:
Inclusion Criteria:

* Prostate cancer
* Initiation of androgen deprivation therapy
* Oral and written informed consent

Exclusion Criteria:

* They withdraw their consent
* Treatment for osteoporosis within the last year
* Other malignancy
* Other bone disease, bedbound, use of steroid