Kornimate/medical-research-clean huggingface dataset:
cbm in the context of exposure for acrophobia

Conditions: Acrophobia

Summary: the proposed study will apply a one-session exposure treatment combined with cbm training modifying interpretational processing biases versus a sham training in acrophobic individuals. the main aim is to advance our understanding of the mechanisms underlying exposure treatment.

the present study will apply a one-session exposure treatment followed by a computerized interpretational training (cbm) or sham training in acrophobic individuals. by doing so, it aims to better understand the mechanisms underlying exposure, i.e., the role of cognitive change. specifically, this study aims to enhance changes in disorder-relevant cognitive processing post-exposure, compared to a sham training. further, we hope to improve both therapy outcomes and the generalization of therapeutic effects.

Eligibility criteria:
inclusion criteria: 1. informed consent 2. sufficient german language skills to complete the experimental tasks and questionnaires 3. aged between 18 and 65 years 4. current primary diagnosis of acrophobia as defined by dsm-5 (based on dips) 5. lives within reasonable travelling distance of the research center exclusion criteria: 1. currently in psychotherapeutic treatment 2. impaired therapy capability (as judged by researcher/clinician) 3. current diagnosis of substance use disorder (via dips) 4. current or past diagnosis of psychotic disorder or bipolar disorder (via dips) 5. acute suicidality (via dips) 6. diagnosis of chronical physical or neurological diseases (self-reported by participant) 7. personality disorder (via dips or via clinical judgement) 8. attention-deficit hyperactivity disorder (self-reported by participant or via dips) 9. intellectual disability (self-reported by participant or via clinical judgment) 10. women: pregnancy or breast feeding (self-reported by participant) 11. intake of medication that could impede the effects of exposure therapy or cbm training (e.g., lorazepam)

Keywords: anxiety disorders acrophobia exposure cognitive bias modification interpretational processing biases
impact of probiotic use on immune cell function in children

Conditions: Respiratory Tract Infections

Summary: probiotics are microorganisms that are believed to provide health benefits when consumed. the term probiotic is currently used to name ingested microorganisms associated with beneficial effects to humans and animals. probiotics are popularized in the lay literature for many different clinical problems. they have been studied in infants and children as a preventive or treatment for a variety of infections. studies on the medical benefits of probiotics have yet to reveal a cause-effect relationship, and their medical effectiveness has yet to be conclusively proven for most of the studies conducted thus far. the putative benefit of probiotics in the prevention of infection relates to potential benefits to the innate and adaptive immune systems of infants. the goals of this investigation are to study immune system cell function and microbiome in children who are taking probiotics. to accomplish this goal, we propose a pilot study for which we will obtain blood and nasopharyngeal and stool samples prior to and post probiotic use in children greater than 12 months-36 months over a 27-38 day period


Eligibility criteria:
inclusion criteria * healthy children greater than 12 months-36 months of age * english speaking parent * child has not received a live vaccine such as mmr or varicella in the past 2 weeks exclusion criteria * asthma/allergic rhinitis * premature birth (\< 36 weeks gestation) * known to be lactose intolerant * immunodeficiency or any underlying problem requiring the use of steroids or other immunosuppressive agents * use of nonsteroidal anti-inflammatory drugs (nsaids) such as ibuprofen in the last 2 weeks * currently taking probiotics, have received probiotics in the previous two weeks or are unwilling to refrain from the use of non-study probiotics during the next 30 days * any antibiotic treatment in the last 2 weeks * conditions which might interfere with dispersion of the probiotic after oral administration such as short gut or anomalies of the digestive tract * concurrently participating in another clinical study, in which the child has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).

Keywords: immune system probiotics
study of tipifarnib as postconsolidation therapy for acute myeloid leukemia in patients 60 years and older

Conditions: Acute Myeloid Leukemia

Summary: the purpose of this study is to determine if giving tipifarnib after standard treatment will prevent leukemia from coming back (relapsing). tipifarnib belongs to a class of drugs called farnesyl transferase inhibitors (fti). it blocks proteins that make leukemia cells grow.

the study is an open-label evaluation of treatment with tipifarnib in approximately 127 subjects, 60 years and older, with aml in complete remission (cr) after consolidation therapy. prior to enrollment, patients will receive 1 or 2 cycles of induction chemotherapy. patients who attain a cr will receive 1 or 2 cycles of consolidation chemotherapy. patients in postconsolidation complete remission who meet the eligibility criteria are offered enrollment in the study. subjects enrolled in the study are treated with tipifarnib a dose-modification scheme is followed to maintain adequate specified laboratory values and to minimize other adverse events. postconsolidation treatment with tipifarnib continues until the time of relapse, death, completion of 24 cycles of treatment, or discontinuation as advised by study doctor. tipifarnib, film coated, compressed tablets containing 100 mg active drug, will be administered orally at a dose of 300 mg (three 100 mg film coated tablets) taken twice a day for 21 consecutive days on a 28-day cycle schedule for up to 24 months.

Eligibility criteria:
inclusion criteria: * newly-diagnosed aml * leukemia in remission * eastern cooperative oncology group (ecog) performance status 0 or 1 exclusion criteria: * acute promyelocytic leukemia (apl) * previous history of myelodysplasia or antecedent hematologic malignancy * previous therapy with a farnesyl transferase inhibitor

Keywords: zarnestra acute myeloid leukemia tipifarnib
efficacy and safety of sofosbuvir/velpatasvir fixed dose combination with ribavirin in chronic hcv infected adults who participated in a prior gilead sponsored hcv treatment study

Conditions: Hepatitis C Virus Infection

Summary: the primary objective of this study is to evaluate the efficacy, safety and tolerability of treatment with sofosbuvir/velpatasvir (epclusa®; sof/vel) with ribavirin (rbv) for 24 weeks in adults with chronic hepatitis c virus (hcv) infection who participated in a prior gilead sponsored study and did not achieve sustained virologic response (svr).


Eligibility criteria:
key inclusion criteria: * willing and able to provide written informed consent * hcv genotype determined by the central laboratory * hcv rna \> lloq at screening * participated and completed a gilead sponsored hcv treatment study of direct acting antiviral (daa) containing regimens. * male and female of childbearing potential must agree to use protocol specified method(s) of contraception key exclusion criteria: * current or prior history: clinically-significant illness (other than hcv) or any other major medical disorder that may interfere with treatment, assessment or compliance with the protocol; individuals currently under evaluation for a potentially clinically-significant illness (other than hcv) are also excluded. * screening ecg with clinically significant abnormalities * laboratory results outside of acceptable ranges at screening * infection with hepatitis b virus (hbv) or human immunodeficiency virus (hiv) note: other protocol defined inclusion/ exclusion criteria may apply.
a study to access safety and efficacy of nebulized tobramycin in patients with bronchiectasis

Conditions: Bronchiectasis

Summary: this is a study to evaluate the efficacy,indications,adverse reactions and resistance of combined administration of nebulized tobramycin compared with systemic administration alone in patients with bronchiectasis in acute exacerbation of bronchiectasis.

bronchiectasis is a chronic disorder of the major bronchi and bronchioles characterized by permanent dilation, microbial infection, a persistent inflammatory response with the release of immune mediators and microbial toxins leading to destruction. the origin of bronchiectasis varies, but the presence of microbial infection and a persistent inflammatory response is typical of the disease. the chronic nature of the infection and the associated considerable morbidity provides the rationale for using aerosolized antibiotics for the treatment of bronchiectasis patients. this is a study of safety and efficacy of combined administration of nebulized tobramycin compared with systemic administration alone in patients with bronchiectasis in acute exacerbation of bronchiectasis. study subjects will be randomized to receive either study drug or placebo by inhalation via a nebulizer. each subject will complete 14 days of daily dosing. clinical laboratory parameters,clinical adverse events and pulmonary function will be evaluated for all study subjects in order to determine the qualitative and quantitative safety and efficacy of nebulized tobramycin.

Eligibility criteria:
inclusion criteria: 1. male or female study subjects ≥18 years of age and ≤80 years of age 2. confirmed diagnosis of idiopathic bronchiectasis or postinfectious bronchiectasis 3. confirmation of infection with p. aeruginosa at screening 4. are sensitive to tobramycin 5. acute exacerbation of bronchiectasis - exclusion criteria: 1. bronchiectasis due to special causes. 2. smokers. 3. are associated with bronchial asthma. 4. have any serious or active medical or psychiatric illness. 5. are not tolerant to nebulised tobramycin 6. fev1.0 reduces ≥ 15% after inhaling tobramycin. -

Keywords: bronchiectasis tobramycin nebulised
comparison of a new automated ventilatory mode named intellivent to standard controlled ventilation in brain injured patients

Conditions: Brain Injured Patients

Summary: comparison of the ability of a new automated ventilatory mode named intellibrain to maintain capnia and oxgen partial pressure within predefined ranges in comparison to the control of capnia and oxgen partial pressure obtained by using standard controlled ventilation modes in brain injured patients. comparison of the numbers of alarms and required settings modifications observed with each ventilatory mode.


Eligibility criteria:
inclusion criteria: * brain injury ( traumatic brain injury, subarachnoi8dal haemorrhage, intracerebral hemorrhage, ischemic stroke) * glasgow coma scale of 9 or less * controlled mechanical ventilation required * intracranial pressure monitoring required for clinical reasons exclusion criteria: * age under 16 years old * clinical signs of brainstem lesions * patients with withdrawal order or for whom organ donation is under discussion * major haemodynamic instability * high carbon dioxide alveoloarterial gradient (\>10 mmhg) and/or suffering of severe hypoxemia (pao2/fio2 \< 150 mmhg) * patients included in another interventional clinical study

Keywords: brain injury controlled ventilation intellivent capnia control
an open label multi-center extension study to evaluate long-term safety/ tolerability of dovitinib in patients with solid tumors who continue to receive treatment with dovitinib (tki258) in novartis-sponsored single agent dovitinib studies which fulfilled the requirements for the primary objective

Conditions: Solid Tumors

Summary: the study allowed continued safety follow-up of patients who were on single agent dovitinib or dovitinib in combination with fulvestrant treatment in a novartis-sponsored study which had met its primary endpoint and were benefiting from the treatment as judged by the investigator.


Eligibility criteria:
inclusion criteria: * patient was currently enrolled in novartis sponsored study, which had met its endpoint and was receiving single agent oral dovitinib or dovitinib and fulvestrant coadministration * patient was currently benefiting from treatment with single agent oral dovitinib or dovitinib and fulvestrant coadministration as determined by the guidelines of the parent protocol and according to the investigator's clinical judgment. * patient had demonstated compliance * patient had given written informed consent. exclusion criteria: * patient had been permanently discontinued from oral dovitinib study treatment, either alone or in combination with fulvestrant, in the parent study * patient was pregnant or nursing at the time of entry * women of child-bearing potential and male patients with sexual partners of child-bearing potential unwilling to use highly effective methods of contraception during dosing and for a specified duration after stopping study treatment

Keywords: solid tumors tki258 dovitinib fulvestrant cancers with a mass bulky tumor nodule lump cancer solid malignancies
pharmacokinetics of linezolid in children with cystic fibrosis

Conditions: Cystic Fibrosis

Summary: to determine the pharmacokinetic profile of iv (intravenous) and po (oral) formulations of linezolid among children with cystic fibrosis and establish a dose regimen that will be safe and effective.

patients with cystic fibrosis who have pulmonary exacerbations associated with the isolation of methicillin-resistant staphylococcus aureus (mrsa) in their sputum will be identified by their primary physicians and by laboratory record review. if they meet the inclusion criteria, they will be invited to participate in the study. the primary outcome variables include pharmacokinetic and pharmacodynamic indices. the study end points include completion of the sputum and blood sampling for pharmacokinetic studies of both intravenous and oral formulations of linezolid and collection of microbiologic specimen (sputum and anterior nares cultures) one month after discharge. additionally, pharmacokinetic data will be analyzed for effects of age and cystic fibrosis transmembrane conductance regulator (cftr) mutation on clearance of linezolid and for relationship between levels of linezolid achieved in sputum and blood and clinical outcome

Eligibility criteria:
inclusion criteria: * subjects \< 18 years of age inclusive, with a confirmed diagnosis of cystic fibrosis being admitted to the hospital for acute pulmonary exacerbation with mrsa isolated from sputum culture. * female subject of childbearing potential must have a negative pregnancy test prior to the first dose of study drug, and if sexually active agrees to use an acceptable method of birth control per investigator judgment for the duration of the study. * subjects who are receiving medications with serotonergic (such as certain types of antidepressants) and adrenergic activity that can not be discontinued based on clinical judgment of the primary physician may be enrolled. these subjects will be monitored closely for serotonin- and sympathomimetic-associated toxicity. * subject (when able) and subject's parent /legal guardian agree to comply with the study requirements. * subject has sufficient venous access to permit administration of the study medication, collection of pharmacokinetic samples and monitoring of safety variables. * duration of linezolid therapy is expected to exceed 7 days. * english and spanish-speaking subjects. exclusion criteria: * subjects with clinical or laboratory evidence of severe hepatic (child-pugh class c) disease * subjects with severe renal impairment (estimated creatinine clearance \<30 ml/min) * subjects with a history of allergy to linezolid. * pregnant and breastfeeding subjects.

Keywords: pharmacokinetic
combination chemotherapy plus radiation therapy in treating patients with advanced pancreatic cancer

Conditions: Pancreatic Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. combining radiation therapy with chemotherapy may kill more tumor cells. purpose: phase ii trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have locally advanced pancreatic cancer.

objectives: * determine the efficacy of gemcitabine, cisplatin, and radiotherapy, in terms of 1-year survival, in patients with locally advanced pancreatic cancer. * determine the toxicity of this regimen in these patients. * determine the quality of life of patients treated with this regimen. outline: this is a multicenter study. patients undergo radiotherapy once daily five days a week for 5.5 weeks. patients receive gemcitabine iv over 30 minutes followed by cisplatin iv over 1 hour twice a week for the first 3 weeks of radiotherapy. beginning 4 weeks after the completion of radiotherapy, patients receive gemcitabine iv over 30 minutes on days 1, 8, and 15. treatment repeats every 28 days for a total of 3 courses in the absence of disease progression or unacceptable toxicity. quality of life is assessed at baseline, at completion of radiotherapy, at completion of chemotherapy, and 3 months after completion of therapy. patients are followed every 3 months for 2 years and then every 6 months for 1 year. projected accrual: a total of 20-47 patients will be accrued for this study within 12-28 months.

Eligibility criteria:
disease characteristics: * histologically confirmed unresectable adenocarcinoma of the pancreas * no cystadenocarcinoma of the pancreas or pancreatic tumors of neuroendocrine origin * prior subtotal resection or gross residual disease * no microscopic residual disease only * no metastatic disease outside of planned study radiotherapy field patient characteristics: age: * 18 and over performance status: * ecog 0-1 life expectancy: * not specified hematopoietic: * absolute neutrophil count at least 1,500/mm\^3 * platelet count at least 100,000/mm\^3 hepatic: * bilirubin no greater than 2 times upper limit of normal (uln) * ast no greater than 3 times uln renal: * creatinine no greater than 1.5 times uln other: * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * able to maintain adequate oral nutrition * no significant infection * no other medical condition that would preclude study * no other malignancy within the past 5 years except non-melanoma skin cancer * no significant nausea or vomiting prior concurrent therapy: biologic therapy: * no prior or concurrent biologic therapy chemotherapy: * no prior chemotherapy * no other concurrent chemotherapy endocrine therapy: * not specified radiotherapy: * see disease characteristics * no prior radiotherapy that would overlap planned study radiotherapy fields surgery: * see disease characteristics * at least 21 days since prior laparotomy

Keywords: stage iii pancreatic cancer adenocarcinoma of the pancreas stage iv pancreatic cancer
prompt - palifermin in reduction of oral mucositis in pbsc transplantation

Conditions: Non-Hodgkin's Lymphoma; Multiple Myeloma

Summary: this is an open-label, single-arm, multicentre study conducted in spain to estimate the effectiveness of palifermin administered at a dose of 60 mg/kg/day iv for 3 consecutive days before the start of the conditioning regimen and for 3 consecutive days after autologous pbsct for treating oral mucositis in patients with nhl and mm who have received high-dose conditioning chemotherapy.


Eligibility criteria:
inclusion criteria: * non-hodgkin's lymphoma (nhl) subjects scheduled to receive beam conditioning chemotherapy followed by autologous pbsct, or multiple myeloma (mm) subjects scheduled to receive high-dose melphalan (200 mg/m2) conditioning chemotherapy, in a one or two-day schedule, followed by autologous pbsct * ≥age 18 years * ecog performance status \ 2 will be accepted provided that it is exclusively due to mm (e.g. pathological fracture) * adequate pulmonary function as measured by a corrected carbon monoxide (co) diffusing capacity (dlco) ≥ 60% of predicted * left ventricular ejection fraction (lvef) ≥ 50% * minimum of 1.5 x 10\^6 cd34+ cells/kg for autologous transplantation * adequate haematological function (anc ≥ 1.5 x 10\^9/l and platelet count ≥ 100 x 10\^9/l) * serum creatinine \<= 2.0 mg/dl * total bilirubin \<= 2 mg/dl * aspartate aminotransferase (ast) and alanine aminotransferase (alt) \<= 4.0 x iuln * negative serum or urine pregnancy test for women of child bearing potential within 14 days prior to enrolment * each subject must give informed consent directly or through a legally acceptable representative before participating in any study specific procedure, or receiving any study medication. exclusion criteria: * history of or concurrent cancer other than nhl or mm * prior treatment with palifermin, or other keratinocyte growth factors (eg, kgf-2)- prior autologous or allogeneic transplants * oral abnormalities defined as baseline oral assessment of who grade \>0 * other investigational procedures are excluded * subject currently is enrolled in or has not yet completed at least 30 days since ending other investigational device or drug study(s), or subject is receiving other investigational agent(s) * subject of child-bearing potential is evidently pregnant (eg, positive hcg test) or is breast feeding * subject is not using adequate contraceptive precautions * known to be sero-positive for human immunodeficiency virus (hiv), hepatitis b virus (hbv), or hepatitis c virus (hcv) * subject has known sensitivity to any of the products to be administered during dosing, including e coli-derived products * subject has previously been treated on this study or with other keratinocyte growth factors * unwilling or unable to complete the patient-reported outcome questionnaires * subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with study procedures.

Keywords: oral mucositis non-hodgkin's lymphoma (nhl) conditioning chemotherapy autologous pbsct multiple myeloma (mm) melphalan
hydrolysed rice formula study

Conditions: Cow's Milk Protein Allergy

Summary: this non-inferiority study aims to determine whether a hydrolysed rice protein formula is as effective as a cow's milk protein based extensively hydrolysed formula using a double-blind, randomised-controlled design over a 28-day intervention period followed by a 2-month follow-up period in infants 0-13 months of age presenting with symptoms/clinical history suggestive of cow's milk allergy. the primary outcome is growth, and secondary outcomes are gastrointestinal tolerance, and differences in intake, allergic symptoms, parental qol, acceptability, dietary intake, and safety.


Eligibility criteria:
inclusion criteria: * male or female * aged 0-13 months * presenting to primary or secondary care with symptoms/clinical history suggestive of cma * will receive at least 30% of energy requirements from the study formula * written informed consent from parent/carer exclusion criteria: * severe cma (including anaphylaxis) and/or requiring an aaf * faltering growth (based on nice guidelines36 - appendix 1) * previous allergy to any study product ingredients (including whey hydrolysate and/or rice) * primary lactose intolerance * food protein-induced enterocolitis syndrome (fpies) * exclusively breast fed * severe concurrent or chronic disease or genetic syndrome that may impact growth or other outcomes * severe hepatic or renal insufficiency * premature infants (born \<37 weeks) with a corrected age of \<4 weeks * requirement for any parenteral nutrition * participation in other clinical intervention studies within 1 month of recruitment * concern around the willingness/ability of the caregiver to comply with the study protocol and/or study requirements