Kornimate/medical-research-clean huggingface dataset:
study of addition of panitumumab to chemoradiation therapy in patients with locally advanced head and neck cancer

Conditions: Head and Neck Cancer; Squamous Cell Carcinoma

Summary: the addition of chemotherapy to radiotherapy (chemoradiation) has improved outcomes for patients with locally advanced squamous cell carcinoma of the head and neck but additional improvements to treatment regimens are needed. the study is investigating if the addition of a targeted therapy (panitumumab) can improve the efficacy of chemoradiation without adding unmanageable toxicity.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of stage iii or iva-b (m0) squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx or larynx * eastern cooperative oncology group (ecog) performance status of 0 or 1 (you must be well enough to receive chemoradiation therapy) * you must be at least 18 years of age * your test results must show that your kidneys, liver and blood cells are working adequately and that, if you are female, you are not pregnant * you must have measurable disease exclusion criteria: * cancer of the nasopharynx, sinus, salivary gland or skin * history of another cancer (other than head and neck) unless treated with curative intent and with no evidence of disease for more than 3 years, with the exception of non-melanoma skin cancer or in situ cervical cancer * previous treatment with anti-endothelial growth factor receptor (egfr) antibody therapy or egfr inhibitors * previous treatment for head and neck cancer, with chemotherapy, surgery (except nodal sampling or biopsy) or radiotherapy * clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) within one year before you join the study * chronic obstructive pulmonary disease (pneumonia or respiratory decompensation) resulting in hospitalization within 6 months of study screening * history or evidence of interstitial lung disease (e.g. pneumonitis or pulmonary fibrosis) * major surgery within 28 days of screening

Keywords: head and neck cancer panitumumab
assessment of right ventricular function in advanced heart failure

Conditions: Dilated Cardiomyopathy; Heart Failure

Summary: we examined the feasibility and reliability of a combined echocardiographic and right heart catheterization (rhc) approach for right ventriculo/arterial (r-v/a) coupling assessment in hf patients with dilated cardiomyopathy (d-cmp).

this is a single center, retrospective cross-sectional study. in 2016-17, for 6 months, we evaluated for eligibility 81 consecutive d-cmp patients afferent to "niguarda great metropolitan hospital" for rhc and echocardiography. all participants underwent the exams in the context of heart-transplant or advanced hf evaluation. inclusion criteria were: 18 years old, given informed consent, d-cmp, new york heart association (nyha) functional class ii or iii and reduced ef (≤ 35%). on the contrary, exclusion criteria were: missing the inclusion criteria and refused informed consent. the final sample consisted of 68 study participants (mean age 64±7 years, 82 % male).

Eligibility criteria:
inclusion criteria: * 18 years old * given informed consent * d-cmp * new york heart association (nyha) functional class ii or iii * reduced ef (≤ 35%) exclusion criteria: * missing the inclusion criteria * refused informed consent

Keywords: heart failure ventricular elastance dilated cardiomyopathy right heart systolic function right ventriculo-arterial coupling
multi-drug resistant bacteria carriage after travel

Conditions: Beta Lactam Resistant Bacterial Infection (Disorder)

Summary: during one month, from 1st to 30th november 2016, all patients admitted in one of the medical dpt of our hospital (internal medicine dpt, endocrinology, icu) will be screened for multi-drug resistant bacteria carriage (after written consent). they will answer to a questionnaire about previous travel in a foreign country during the previous year, hospitalization or not during this travel.

during one month, from 1st to 30th november 2016, all patients admitted in one of the medical dpt of our hospital (internal medicine dpt, endocrinology, icu) will be screened for multi-drug resistant bacteria carriage (after written consent), regardless a travel in a foreign country during the past year, or not. they will answer to a questionnaire about previous travel in a foreign country during the previous year, hospitalization or not during this travel. the aim of the study will be to compare the rate of carriage of multi-drug resistant bacteria among previous travelers, or not.

Eligibility criteria:
inclusion criteria: * all patients admitted in one of the medical dpt of our hospital who have travelled in a foreign country during the previous year exclusion criteria: * patients who were unable to give written consent
observation of clozapine treatment safety in bipolar disorder.

Conditions: Bipolar Disorder

Summary: the purpose of the registry is to record incidence of adverse events during treatment with clozapine in patients suffering from bipolar disorder.

bipolar disorder, with its spectrum, remains a life-long and significant mental health concern due to its unpredictable nature and varied symptomatology. despite the wide array of available treatments, some cases of bipolar disorder remain resistant to traditional medications. clozapine, traditionally used for treatment-resistant schizophrenia, has shown promising results in managing resistant cases of bipolar disorder, particularly reducing the risk of suicide. there are not enough controlled studies on clozapine, especially in treatment resistant bipolar depression. there are certain limitations associated with the use of clozapine, primarily related to the possibility of adverse events including agranulocytosis, myocarditis, pneumonia, intestinal obstruction and seizures. therefore, there is a need for more studies on safety and tolerability of this treatment in patients with bipolar disorder.

Eligibility criteria:
inclusion criteria: * diagnosis of treatment-resistant depressive episode in the course of bipolar disorder according to dsm-5. * age from 18 to 65 years old. exclusion criteria: * patients unable to give fully written informed consent * patients unable to comply with the requirements

Keywords: clozapine bipolar disorder suicidality adverse events
usefulness of medroxyprogesterone acetate in follicular phase in oocyte donors. undergoing ovarian stimulation

Conditions: Infertility

Summary: the purpose of this study is to determine whether medroxyprogesterone acetate (mpa) administration in follicular phase prevents premature luteinization with equal efficiency as gnrh antagonists and otains similar clinical results in oocyte donation.

within the new guidelines for stimulation, the use of oral progesterone in follicular phase allows gnrh analogue administration, resulting in greater comfort for patients as well as a reduction in cost. obtained results are similar to those from conventional protocols in terms of: early luteinization, number of oocytes, embryos number and rate of implantation and gestation or appearance of congenital malformations. another advantage is the lower incidence of ohss (ovarian hyperstimulation syndrome). from a scientific point of view, it would allow a better understanding of folliculogenesis, of progesterone mechanism of action on blocking lh secretion and its effect on ovarian and later embryonic level. from a clinical point of view, it would simplify cos (controlled ovarian stimulation) by reducing the number of medication administered subcutaneously and their possible side effects on both systemic and local levels. it would be of special interest in 2 groups of patients, for example, oocyte donors and patients undergoing preservation of fertility. to date, there is a lack of studies along these lines.

Eligibility criteria:
inclusion criteria: * age between 18-35 years (both included) * regular menses (between 25-35 days) * absence of physical and psychic pathologies at the time of oocyte donation * bmi: 18-28 kg(m2 at the time of oocyte donation. * other criteria to comply with: i. with no relevant personal or family medical history ii. signing of informed consent iii. from a medical point of view: 1. healthy ovaries and uterus, with no organic pathology 2. ovaries without polycystic aspect 3. antral follicle count \> 12 in the sum of both ovaries 4. normal karyotype 5. negative results in infectious illness screening (hepatitis b virus; hepatitis c virus, vih virus syphilis) 6. results within range of general analysis of hemogram, hemostasia y biochemistry. exclusion criteria: * any systemic or metabolic disorder which contraindicate the use of gonadotrophines * medical background of trombophlebitis or thromboembolic phenomena or arterial hypertension * severe hepatic insufficiency, cardiovascular illness * suspicion or evidence of malignity of mamarian glands or other hormone dependant genital organs * known infection of hepatitis b virus; hepatitis c virus or vih virus * known hypersensitivity to pma or its excipients * any reason or cause which excluede from the oocyte donation program * participation in another clinical trial in the two months prior to the inclusion on this study
effect of riociguat on bone metabolism

Conditions: Pharmacology, Clinical

Summary: investigation of the effect of riociguat, administered as 2.5 mg ir-tablets tid over 14 days, on bone metabolism.

clinical pharmacology

Eligibility criteria:
inclusion criteria: * healthy male white subjects * 18 to 45 years of age * bmi between 18 and 28 kg/m2 * subjects who are able to understand and follow instructions and who are able to participate in the study for the entire period exclusion criteria: * relevant deviation from the normal range in the clinical examination; in clinical chemistry, hematology, or urinalysis * resting heart rate in the awake subject below 45 bpm or above 90 bpm * systolic blood pressure below 100 mmhg or above 145 mmhg * diastolic blood pressure above 95 mmhg * relevant pathological changes in the ecg such as a second or third-degree av block, prolongation of the qrs complex over 120 msec or of the qt / qtc-interval over 450 msec for males * history of genetic muscle or bone disease of any kind * completely sedentary or extremely fit subjects * fractures in the preceding 12 months * psychiatric diseases * history of peptic ulcers or relevant gastro-esophageal reflux disease * subjects with hypersensitivity to the investigational drug riociguat or ranitidine, or to inactive constituents * regular daily consumption of more than half a liter of usual beer or the equivalent quantity of approximately 20 g of alcohol in another form, more than 1 l of xanthine-containing beverages, recent smoking history * use of medication within the 2 weeks preceding the study which could have interfered with the investigational drug riociguat or ranitidine * subjects with a medical disorder, condition or history of such that would have impaired the subject's ability to participate or complete this study in the opinion of the investigator or the sponsor

Keywords: bone metabolism
endometriosis biomarker discovery study

Conditions: Chronic Pelvic Pain; Endometriosis

Summary: this is a prospective, single time point, discovery study intending to identify biomarkers that can differentiate endometriosis from other underlying reasons for pelvic pain. patients undergoing laparoscopy for evaluation of chronic pelvic pain or elective tubal ligation will be enrolled for collection of tissue samples at the time of laparoscopy.

this study will be a prospective collection of blood, urine, and endometrial tissue from women with chronic pelvic pain symptoms, with or without infertility, who require evaluation by laparoscopy. women undergoing laparoscopy for elective tubal ligation will also be investigated similarly and serve as the negative control. subjects will be queried regarding sociodemographic characteristics, medical and reproductive history, pain and lifestyle as well as assessment for differential diagnoses such as interstitial cystitis and idiopathic bowel syndrome. endometriosis severity will be captured by rasrm staging during laparoscopy.

Eligibility criteria:
inclusion criteria: 1. able to give informed consent. 2. aged 18-45 years old who has a regular menstrual cycle (26 to 32 days in length). 3. undergoing a planned diagnostic or therapeutic laparoscopy for the indication of pelvic pain or for elective tubal ligation. 4. one prior pregnancy for tubal ligation patients. exclusion criteria: 1. prior surgical diagnosis of endometriosis. 2. currently pregnant or breastfeeding. 3. clinical suspicion of pelvic inflammatory disease (pid) or urinary tract infection. 4. current malignancy except non-melanoma skin cancer adequately treated. 5. known major systemic disease, including but not limited to inflammatory disease, autoimmune disease. 6. use of immunosuppressants in the past 3 months. 7. use of injectable reproductive hormonal therapy within the past 3 months and have not menstruated since last dose. 8. if reproductive hormonal implant has been used in the past, it must have been removed \> 3 months prior to study entry and subject must have menstruated since removal. 9. use of intrauterine device (iud) in the past 3 months. 10. use of any other reproductive hormone therapy within the past 3 months, except for oral contraceptives (ocps).
printed aligners for nasoalveolar molding treatment

Conditions: Unilateral Complete Cleft Lip and Palate

Summary: study will provide nasoalveolar molding (nam) treatment, special care for infants born with cleft lip and palate. this novel appliance will help to provide the care in accurate and easy form by help of both digital work flow and new material which provide a unique properties.

a sample of 10 infants born with unilateral cleft lip and palate (uclp) ranging in age from seven to 45 days who meet the inclusion criteria will be recruited and subjected to the following study procedures: maxillary impression, extraoral scanning for nasolabial area and facial photos. for digital workflow; the following steps will be done: 1. digital model preparation. 2. model segmentation and modification. 3. virtual treatment simulation. 4. virtual appliance construction. 5. three-dimensional aligner printing. after aligners printing, each infant will be delivered his own set of aligners. the nasal stent will be fixed to the aligner then delivered with a meticulous demonstration for parents regarding adhesive placement, insertion, and removal. parents will be instructed to remove the aligner once per day for proper cleaning. infants will be followed up every two weeks till maxillary arch segments approximation and improvement of nasolabial tissue morphology. finally, post-treatment records will be taken. • study setting: the study will be performed in the clinic of the orthodontic department, faculty of dentistry, ain-shams university. • study procedure: infants who meet the inclusion criteria and approve participation in the study will be included. an informed consent will be signed by the infant's parents before their enrollment in the study in which the aim of the study, the methodology, and possible complications will be clearly described. this research will be reviewed by the research ethics committee, faculty of dentistry, ain shams university. ix. statistical analysis methods of assessment 1. pre-operative t1 and postoperative t2 models will be digitally measured, assessed and compared. 2. pre-operative t1 and postoperative t2 soft tissue scans will be digitally measured, assessed and compared. 3. final virtual models and final infant models will be digitally compared. 4. total treatment duration will be calculated. finally, data will be tabulated and statistically analyzed

Eligibility criteria:
inclusion criteria 1. non-syndromic complete unilateral cleft lip, alveolus, and palate. 2. age is up to 45 days. 3. cleft size more than 5mm between anterior margins of cleft segments. exclusion criteria 1. infants are diagnosed with other congenital malformations. 2. parents refusing nam treatment. 3. parents are unable to attend the clinic every 2 weeks. 4. infants are born with another form of clefts like facial and median clefts.

Keywords: 3-dimensional aligner nam segmentation approximation
immobilization in external rotation of acute shoulder dislocations

Conditions: Anterior Shoulder Dislocation

Summary: the purpose of this study is to determine whether immobilizing the affected shoulder of first time anterior shoulder dislocation patients in external rotation (vs immobilization in traditional internal rotation) reduces the rate of recurrent dislocations experienced in 24 months.

immobilizing the affected shoulder of first time anterior shoulder dislocation patients in external rotation (vs immobilization in traditional internal rotation)should reduce the rate of recurrent dislocations experienced in 24 months.

Eligibility criteria:
inclusion criteria: * skeletally mature patients less than 30 years of age * sustained an acute, first-time, traumatic anterior dislocation of the shoulder as defined by; i. mechanism of abduction, external rotation ii. sudden pain in the shoulder iii. manipulative reduction required or iv. radiograph documenting a dislocated joint * willing to participate in follow-up for at least two years exclusion criteria: * incompetent or unwilling to consent * inability or unwillingness to comply with rehabilitative protocol or required follow-up assessments * previous instability of the affected shoulder * significant associated fracture (exception hill sachs or bankart lesions) * concomitant ipsilateral upper extremity injuries which may affect the patient's ability to participate in, or benefit from, a rehabilitative program * a history of significant ligamentous laxity or demonstrated multi-directional instability of the contralateral shoulder * neurovascular compromise of the affected limb * a medical condition making the patient unable to wear a brace or sling

Keywords: immobilization in external rotation acute primary anterior shoulder dislocation
mefirst: a tailored intervention to hpv vaccine decision making

Conditions: Human Papillomavirus-Related Carcinoma

Summary: this study will test whether a tailored, online educational intervention increases hpv vaccine uptake and intent among female college students.

mefirst is the first web-based, online, educational tool designed to promote human papillomavirus (hpv) vaccine awareness and understanding in an effort to improve hpv vaccine intent and uptake among female university students. hpv is the most common sexually transmitted infection and causes genital warts and cancer. the hpv vaccine has been recommended for girls ages 11-26 since 2006, yet vaccination rates remain low. tailored online interventions may be more effective tools to promote behavior change among college students than traditional static interventions. the proposed study is a randomized controlled trial testing the efficacy of the mefirst tool vs. standard static educational material on increasing hpv vaccination intent and uptake among female university students aged 18-26.

Eligibility criteria:
inclusion criteria: * enrolled at the university of michigan exclusion criteria: * receipt of any doses of hpv vaccine

Keywords: tailored intervention college aged students hpv
effects of nervous system mobilization

Conditions: Healthy Individuals

Summary: this study aims to compare the effect of tension neural mobilization versus sliding neural mobilization of the peroneal nerve on the heat and cold threshold, on pressure pain threshold and on flexibility both in the dominant lower limb (subjected to mobilization) and the non-dominant lower limb (not subjected to mobilization) in healthy young participants.

sixty young and healthy participants will be randomly allocated to receive tension neural mobilization (n=30) or sliding neural mobilization (n=30). data on heat threshold, cold threshold, pressure pain threshold and lower limb flexibility will be collected before the intervention, immediately after the intervention and at least 24h after the intervention.

Eligibility criteria:
inclusion criteria: * naïve to nervous system mobilization; exclusion criteria: * any surgery or trauma in the previous 6 months; neurological, cardiorespiratory or rheumatic pathology; cancer.
mechanisms and management of infant dysphagia

Conditions: Dysphagia; Airway Aspiration; Airway Penetration

Summary: the purpose of the investigator's study is to evaluate the causes of feeding difficulty in infants. new treatments can be possible only if the cause is known. in this study, the investigator plans to evaluate the movement of the muscles in an infant's mouth, throat (pharynx) and food pipe (esophagus) that are responsible for moving the food down into the stomach and that help protect an infants airway.

infants with chronic feeding difficulties exhibit inadequacy of suck-swallow and breathe coordination, regurgitation or vomiting, gastroesophageal reflux disease, and airway aspiration. often these infants must rely on feeding tubes, either inserted through the nose or surgically placed, to meet their nutrition and hydration needs until they are able to orally feed safely, effectively, and efficiently. the process of assessment and treatment of swallowing disorders is often stressful for the infants and their providers, including parents. the goal of this study is to combine two commonly used diagnostic techniques (video fluoroscopy swallow studies and esophageal manometry) to more comprehensively evaluate feeding from the mouth to the stomach in infants. the hope is that by doing so treatment strategies can be improved. : eligible subjects (study) will undergo diagnostic vfss in combination with manometry, either concurrent or sequential. they will have parental choice of preferred feeding therapy. the data is from single center prospective observational study. the controls are those who had vfss alone with provider recommendations from the same single center. in addition, we are also embarking on alternate strategies to achieve the original stated aims: 1) mechanisms of dysphagia is ascertained by studying concurrent recordings of vfss and manometry. 2) feeding outcomes of dysphagic infants are ascertained by evaluating the discharge outcomes and 1-year feeding outcomes among those that had evaluation of dysphagia using vfss. 3) dysphagic infants that had sequential vfss and manometry studies are evaluated to test which method is a better predictor of stated outcomes.

Eligibility criteria:
inclusion criteria: * infants with feeding-related aero-digestive symptoms * ≤60 weeks pma (both pre-term and full term) * history of orally feeding ≥ 25% of least 50% of prescribed feeding volume * room air or supplemental oxygen of ≤1liter/minute (lpm) exclusion criteria: * direct breast feeding exclusively * known genetic, metabolic or syndromic disease * neurological diseases such as grade 3 or 4 intraventricular hemorrhage (ivh) or intracranial hemorrhage (ich), moderate to severe perinatal asphyxia or stroke * craniofacial, airway or foregut malformations * history of craniofacial, foregut, ears, nose and throat (ent) or neurosurgery

Keywords: infant feeding difficulties dysphagia