Kornimate/medical-research-clean huggingface dataset:
ieat 2.0 open trial

Conditions: Gastrointestinal Disorders

Summary: the purpose of this study is to learn more about the eating behaviors of children with chronic food refusal. specifically, investigator's aim to see how the integrated eating aversion treatment (ieat) may affect a child's food consumption. the manual is a structured multidisciplinary treatment, including a psychologist and dietitian with consultation from a speech-language pathologist. the treatment is designed to increase the volume of foods a child eats and decrease their reliance on a feeding tube or formula. the manual includes informational handouts, data collection forms, and instructions to guide the increase in feeding demands while reducing reliance on formula to meet a child's nutritional needs. children with chronic food refusal will participate in this study at the marcus autism center. all children who enroll will receive the ieat treatment. this involves 10 bi-weekly sessions that last approximately one hour, over the course of 5 months and a 1 month follow-up visit. therefore, the study will last a total of 6 months.

this study seeks to further the development of ieat by including participants that demonstrated improvements in a previously conducted pilot study, and finalize the treatment manual to include the standardized decision rules to increase feeding demands, further integrate the multidisciplinary team (nutrition and speech pathology), and include supplementary sessions to better address individual treatment needs. investigators propose to enroll participants with chronic food refusal and formula or feeding tube dependence. treatment will involve 10 biweekly outpatient appointments and 1 follow-up appointment of about 1 hour in length. assessment and treatment will involve a multidisciplinary team including behavioral psychology, speech pathology and nutrition. target behaviors including grams consumed, percent dependence on formula/feeding tube, and the clinical global impression scale, which will be assessed during a meal observation, 3-day food record, and evaluation with the dietitian and independent evaluator. participants will be assessed pre-treatment, mid-treatment, and post-treatment and complete a one month follow-up to assess long term effects.

Eligibility criteria:
inclusion criteria: * present with partial food refusal as evidenced by greater than 75% of caloric needs met by bottle, formula, or tube feedings * have a medical history significant for an organic factor (e.g., gastrointestinal issues) which influenced the development of feeding concern * safe to consume up to 100% of his/her needs orally * parents of subjects must be english literate * ability to complete at least 2 structured meals each day exclusion criteria: * active medical diagnoses requiring hospitalization or significant oversight from a physician * active medical, structural, or functional limitations preventing safe oral intake of pureed foods

Keywords: nutrition behavioral
the effect of simulated obstructive apnoea and hypopnoea on heart rhythm in patients with paroxysmal atrial fibrillation

Conditions: Patients With Paroxysmal Atrial Fibrillation

Summary: in this randomised controlled cross-over study we will investigate whether intrathoracic pressure changes induced by simulated obstructive apnoea and hypopnoea trigger premature supraventricular and ventricular contractions as well as atrial fibrillation in patients with paroxysmal atrial fibrillation.


Eligibility criteria:
inclusion criteria: * age 18-75 years * history of ecg-documented paroxysmal atrial fibrillation within the last 12 months and currently in sinus rhythm * informed consent exclusion criteria: * mental or physical disability precluding informed consent or compliance with the protocol * amiodarone or dronedarone medication * previous radiofrequency ablation for atrial fibrillation * severe structural heart disease
a phase 2, multi-center study to evaluate the efficacy and safety of ono-2952 in female subjects with diarrhea-predominant irritable bowel syndrome (ibs-d)

Conditions: Irritable Bowel Syndrome (IBS)

Summary: the objective of this study is to explore efficacy, safety and tolerability of ono-2952 in female subjects with diarrhea-predominant irritable bowel syndrome (ibs-d).


Eligibility criteria:
inclusion criteria: 1. female 18-65 years of age (inclusive) 2. diagnosed with ibs based on the following criteria (rome iii criteria): * symptom onset at least 6 months prior to diagnosis, and * recurrent abdominal pain or discomfort at least 3 days per month for the past 3 months, and * abdominal discomfort or pain associated with two or more of the following at least 25% of the time: 1. improvement with defecation 2. onset associated with a change in frequency of stool/defecation 3. onset associated with a change in form (appearance) of stool 3. diagnosed with ibs-d, defined as loose/watery stools ≥ 25% and hard/lumpy stools ≤ 25% of defecations exclusion criteria: * any structural abnormality of the gastrointestinal (gi) tract (other than esophagitis or gastritis) * history of crohn's disease, ulcerative colitis, diabetes mellitus, lactose malabsorption, malabsorption syndromes, celiac sprue, or any upper gi symptoms that may impact the assessment of ibs symptoms

Keywords: irritable bowel syndrome ibs ono-2952
a study of abt-378/ritonavir combination in hiv-infected patients who have taken protease inhibitors

Conditions: HIV Infections

Summary: the purpose of this study is to see if it is safe and effective to give abt-378/ritonavir combination plus nevirapine plus two nucleoside transcriptase inhibitors to hiv-infected patients who previously have taken protease inhibitors. this study also examines how the body handles this combination of anti-hiv drugs.


Eligibility criteria:
inclusion criteria concurrent medication: allowed: - antiretroviral regimen containing a protease inhibitor and one or two nucleoside reverse transcriptase inhibitors that has not changed in the last 12 weeks. patients must have: - hiv infection with plasma hiv rna of at least 1,000 copies/ml and less than or equal to 100,000 copies/ml at screening. prior medication: allowed: naive to or has had less than 8 weeks of at least one nucleoside reverse transcriptase inhibitor and an acceptable regimen of two nucleoside reverse transcriptase inhibitors. exclusion criteria concurrent medication: excluded: * medications that are contraindicated with abt-378/ritonavir for the duration of the study, such as midazolam, triazolam, terfenadine, astemizole, cisapride, pimozide, ergotamine and dihydroergotamine. * over-the-counter medicine or alcohol, without knowledge or permission of the investigator. patients with the following prior conditions are excluded: * evidence of acute illness determined by vital signs, physical examination, or laboratory results. * clinically significant abnormal ecg results. * positive test result for drug abuse with the exception of cannabis, unless the investigator anticipates cannabis use will interfere with compliance with the study. prior medication: excluded: * investigational drugs with the exception of amprenavir within 28 days prior to the initiation of study dosing. * treatment with a non-nucleoside reverse transcriptase inhibitor. * treatment with a protease inhibitor different from the current protease inhibitor for more than 6 weeks prior to current regimen. * treatment with more than one protease inhibitor concurrently. risk behavior: excluded: * active substance abuse, alcohol abuse, psychiatric illness. * presumption, by investigator, of poor compliance to regimen.

Keywords: drug therapy, combination nevirapine hiv protease inhibitors ritonavir reverse transcriptase inhibitors
global self-management telematic support for patients with obstructive sleep apnea.

Conditions: Obstructive Sleep Apnea; Telemedicine; Compliance, Patient

Summary: this clinical trial compares the usual follow-up to a program of telematic control and self-management in a group of patients with severe obstructive sleep apnea-hypopnea syndrome (osahs), few symptoms and treated with continuous positive airway pressure (cpap). the objective of the intervention is to achieve a cpap compliance of ≥4 hours per day in at least 90% of the subjects.

low cpap compliance in osahs could mean that its possible cardiovascular benefits are not achieved. telemedicine can be an effective tool to increase cpap compliance with low cost. the researchers propose to carry out a randomized study about patients with severe osahs and few symptoms, who are expected to have low cpap compliance. the main objective is to evaluate if a telematic control and self-management program can increase the compliance with cpap treatment compared to conventional follow-up, getting at least 90% of patients to use cpap ≥ 4 hours per day. sixty patients from the pneumology departments of two hospitals, diagnosed with severe osahs and with few symptoms (epworth sleepiness scale ≤10) will be randomized to two follow-up groups, telematic and conventional, for 6 months. patients in the intervention group (telematic monitoring) will collect variables related to symptoms of sleep apnea and side effects of cpap treatment, using their own smartphone or a tablet provided during the study if they prefer. other variables as the hours per day of cpap use, leaks and residual apnea-hypopnea index (ahi) will be transmitted daily and automatically from latest generation cpap. all information will be processed and each variable will generate alarms and instructions for each patient, allowing the self-management and an early solution of the possible problems related to the treatment. alarms may also be generated in the database if the professional intervention is necessary. in addition, before starting cpap treatment and after six months of treatment, patients will be monitored during a week with a watch-like device. variables related to circadian rhythm will be collected and analyzed to know the effect of cpap treatment in both groups (control and intervention groups).

Eligibility criteria:
inclusion criteria: * patients with a recent diagnostic of osahs with ahi≥ 30 and indication of cpap. * age≥ 18 years * few symptoms, so that, without hypersomnolence (epworth sleepiness scale ≤ 10) * absence of clinic suspect or confirmation of other sleep pathology * with interest in the use of new technologies exclusion criteria: * nasal obstruction that prevents the use of cpap * psycho-physical inability to complete questionnaires and carry out the program * patients undergoing uvulopalatopharyngoplasty * cheyne-stoke syndrome * pregnancy * absence of informed consent * shift work in the last 3 months and transmeridian trips in the last month.

Keywords: cpap treatment self-management
turmeric as treatment in epilepsy

Conditions: Epilepsy; Dravet Syndrome; Lennox-Gastaut Syndrome; Tuberous Sclerosis; Focal Seizures

Summary: this is a single center open-label pilot clinical trial of patients 1-70 years of age with greater than 6 seizures per month diagnosed with dravet syndrome, lennox-gastaut syndrome, tuberous sclerosis, or focal seizures. twenty patients will be enrolled and treated with a stable dose of orally administered turmeric oil daily for 3 months. patients and caregivers will be asked to keep a seizure diary logging all clinical events during the course of the study. serum comprehensive metabolic panel, complete blood count with differential, and antiseizure medication levels, will be monitored at baseline, 1.5 months, and at the end of 3 months.


Eligibility criteria:
inclusion criteria: * patients with greater than greater than six seizures per month diagnosed with dravet syndrome, lennox-gastaut syndrome, tuberous sclerosis, or focal seizures followed at nyu cec. exclusion criteria: * patients expected to have changes to any medications or supplements during study period * exposure to any investigational agent in the month prior to study entry * pregnant or breast feeding women, positive pregnancy test * history of non-compliance * known drug or alcohol dependence * known baseline hematologic * liver function * renal function * absorption * absorption

Keywords: turmeric oil antiseizure medications ar-turmerone
assessing parathyroid glands vascularisation by icg fluoroscopy

Conditions: Parathyroid Function Low Adverse Event

Summary: evaluate parathyroid gland perfusion during total thyroidectomy or thyroid totalisation surgery. create an objective basis for the decision whether or not to transplant the parathyroid glands. avoide postoperative serum calcium and parathyroid hormone dosages, and thus abstention of systematic supplementation with calcium and vitamin d in case of good perfusion.

parathyroid intraoperative indocyanine green (icg) angiography is a new concept. to simplify the procedure the investigators have classified images into three categories: icg 2: good blood supply (the gland has a white color); icg 1: traumatic gland (the gland has a grayish color) and icg 0: the gland is not vascularized (she has a black color). the investigators have applied the same criteria for visual values. the investigators will randomize 138 patients with good icg test values (at least one gland that is visually ≥1 and icg 2): 69 will be subject to the usual postoperative care in the investigators service: 24 hours monitoring with dosage of calcium and pth in the morning on postoperative day 1 and routine supplementation with calcimagon d3 forte (1g calcium and 800 iu of 25-oh-vitamin d) bd by mouth until postoperative follow-up appointment, which takes place between day 10 and 15. depending on the results of blood tests patients will also be given rocaltrol substitution (1, 25-oh-vitamin d) 0.5mcg bd. the remaining patients will be monitored 24 hours in hospital looking for clinical signs and symptoms of hypocalcemia but without any blood dosage or systematic supplementation. if signs and / or symptoms of hypocalcemia develop (tingling, muscle spasms, chvostek sign), a blood test will be performed and patients will be substituted by the usual protocol. all patients will be reviewed at 10 - 15 days of the intervention with the relevant balance sheet.

Eligibility criteria:
inclusion criteria: * adult patients undergoing total thyroidectomy or a totalisation thyroid procedure. * patients capable of understanding and able to understand the study. * values visually 2 and icg 2 exclusion criteria: * parathyroid disease or prior parathyroidectomy * lack of informed consent * altered mental status of the patient. * icg values \<2.

Keywords: parathyroid gland angiography parathyroid gland indocyanine green angiography parathyroid gland indocyanine green fluoroscopy
the effect of bms-986142 on the pharmacokinetics of a combined oral contraceptive (oc) containing ethinyl estradiol (ee) and norethindrone acetate (net) in healthy female subjects

Conditions: Arthritis

Summary: this is an open-label, 2-cycle, multiple-dose, single-sequence study in women of child-bearing potential. the primary objective is to assess the effect of bms-986142 on the pharmacokinetics (pk) of combined oral contraceptive containing ethinyl estradiol and norethindrone acetate.


Eligibility criteria:
inclusion criteria: * signed informed consent * target population: healthy females with no clinically significant deviations from normal in medical history, physical examinations, vital signs, electrocardiograms (ecgs), physical measurements, and clinical laboratory tests that are willing to switch to loestrin during the study. * body mass index (bmi) between 18 to 32 kg/m2. * women of childbearing potential with intact ovarian function and history of regular menstrual cycles must have been on a stable regimen of combination of birth control containing ethinyl estradiol without evidence of clinically significant breakthrough bleeding or spotting for at least 2 consecutive months prior to day -1. * women of childbearing potential must agree to follow instructions for method(s) of contraception for the duration of treatment with study drugs (53 days) plus 5 half-lives of bms-986142 (3 days) plus 30 days (duration of ovulatory cycle) for a total of 86 days. exclusion criteria: * history of any chronic or acute illness including active tb in the last 3 years, recent infection, gastrointestinal disease, smoking within less than 6 months prior to dosing, alcohol abuse, inability to tolerate oral medication, or inability to be venipunctured. * history of jaundice or irregular bleeding associated with taking oral contraceptives, frequent headaches, cerebrovascular or coronary-artery disease, retinal vascular lesions, cancer of the breast or endometrium, deep venous thrombosis, pulmonary embolism, stroke, transient ischemic attack, or phlebitis. * vaccination or plans for vaccination with any live vaccine 12 weeks prior to first dose of study drug, during the course of the study, or 30 days after the last dose of study drug. * evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, electrocardiograms, or clinical laboratory determinations beyond what is consistent with the target population. * history of allergies and adverse drug reaction to any oral contraceptive compounds or bruton tyrosine kinase (btk) inhibitors.

Keywords: rheumatoid
green tea extract and prostate cancer

Conditions: Prostate Cancer

Summary: the purpose of the study is to see if a green tea extract can beneficially alter several markers of cancer risk and progression.

to evaluate the short-term effects of a daily dose of polyphenon e administered during the interval between prostate biopsy and radical prostatectomy in men with recently diagnosed prostate cancer. endpoints will be changes in serum and tissue biomarkers related to progression of cancer. the effect of polyphenon e on tumor cell c-met expression and phosphorylation is the primary objective. secondary objectives include the effects on the other tissue and serum biomarkers. evaluation of the safety and tolerability of polyphenon e in this subject population is another objective. 1.1 determine the effects of polyphenon e on tumor cell c-met expression and phosphorylation levels in patients with prostate cancer 1.2 determine the effects of polyphenon e on pi-3k activation in patients with prostate cancer 1.3 determine the effects of polyphenon e on mapk activation in patients with prostate cancer 1.4 determine the effects of polyphenon e on expression levels of other proteins involved in motility and invasion such as rho gtpases and extracellular proteinases in patients with prostate cancer 1.5 determine the effects of polyphenon e on markers of angiogenesis in patients with prostate cancer 1.6 determine the effects of polyphenon e on serum prostate specific antigen (psa) in patients with prostate cancer 1.7 determine the effects of polyphenon e on other serum markers: c-reactive protein (crp), insulin-like growth factor i (igf-i), insulin-like growth factor binding protein 3 (igfbp-3), hepatocyte growth factor hgf 1.8 evaluate the safety and tolerability of polyphenon e in this subject population

Eligibility criteria:
inclusion criteria: * recent biopsy positive for prostate cancer * scheduled for prostatectomy * must be able to swallow capsules * palpable mass by digital rectal examination (dre) * ability to give informed consent and willingness to adhere to study protocol * age ≥ 18 years and less than 75 exclusion criteria: * abnormal liver function * prior hormonal or surgical therapy for prostate cancer * liver or kidney problems that would interfere with metabolism of study drug * any condition that would hamper informed consent or ability to comply with study protocol * participation in another research study in the last three months * known malignancy at any site other than prostate * recent consumption of green tea (5 or more cups per day, within one week prior to biopsy)

Keywords: egcg polyphenols biomarkers prostate specific antigen
treatment of metastatic melanoma with lenvatinib + anti-pd1

Conditions: Metastatic Melanoma

Summary: the hypothesis is that treatment with lenvatinib + pembrolizumab is less effective in real life than in clinical trials. in fact, an objective response rate \&lt; 20% and a worse tolerability of the treatment in real life with ≥50% of severe toxicities are expected.


Eligibility criteria:
inclusion criteria: * metastatic melanoma (stage iii non operable or stage iv according to american joint committee on cancer staging rules) refractory to immunotherapy (≥ 2nd treatment line after minimum a failure of immunotherapy) exclusion criteria: * uveal melanoma
efalizumab in the treatment of alopecia, phase ii

Conditions: Alopecia Totalis

Summary: determine the effect that treatment with efalizumab has on scalp hair re-growth in younger adults affected by severe variants of alopecia areata, including alopecia totalis, alopecia universalis, and severe ophiasis variants.

this is a phase ii trial (single-center, open-label, prospective study) where subjects with severe forms of alopecia areata, namely alopecia totalis, universalis, and severe ophiasis, will be treated with efalizumab (raptiva), a humanized monoclonal anti-cd11a antibody that reversibly inhibits t cell activation and migration, weekly for 48 weeks. we will assess for effect on hair and body re-growth as well as record any serious adverse events such as serious infections, thrombocytopenia, development of malignancy, and severe arthralgias to monitor for safety outcome data. subjects will have regular physical examinations and laboratory studies throughout the study, as well as telephone interviews.

Eligibility criteria:
inclusion criteria: * ability to provide written informed consent and comply with study assessments for the full duration of the study. * clinical diagnosis of alopecia totalis, alopecia universalis, or severe ophiasis variant of alopecia areata. * 18-40 years of age. * if a female of childbearing potential, a negative pregnancy test and commitment to the use of two forms of effective contraception (birth control) for the duration of the study are necessary. * if a non-sterile male, commitment to the use of two forms of effective contraception (birth control) for the duration of the study is necessary. exclusion criteria: * known hypersensitivity to efalizumab (raptiva) or any of its components. * known liver disease, including active hepatitis * history of autoimmune diseases causing alopecia other than alopecia areata. * prior biologic therapy within 6 months prior to study initiation. * history of any malignancy within last ten years, except treated non-melanoma skin cancers. * any woman currently pregnant or lactating. * intake of systemic immunosuppressive agents, including oral corticosteroids, within 3 months prior to study initiation. * history of positive ppd and/or tuberculosis. * history of hiv/aids * prior enrollment in any efalizumab study * any condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated. * participation in another simultaneous clinical trial involving investigational agents. * positive hiv screening test obtained at screening visit. * positive quantiferon-tb test obtained at screening visit. * positive hepatitis screen obtained at screening visit. * platelet count 150 x 10(9)/l at baseline visit. * presence of any abnormal laboratory value obtained at screening visit assessed as clinically significant by principal investigator.

Keywords: alopecia areata universalis severe ophiasis variants