Kornimate/medical-research-clean huggingface dataset:
prepubertal children with growth failure associated with primary insulin-like growth factor-1 (igf-1) deficiency

Conditions: Growth Disorders; Insulin-Like Growth Factor-1 Deficiency

Summary: this study is intended to determine whether twice daily weight based dosing with recombinant human insulin-like growth factor (rhigf-1) will safely and effectively increase the growth of prepubertal children with short stature associated with low igf-1 levels but who produce sufficient growth hormone (gh). subjects will be randomized to either an observation arm or to active treatment.

prepubertal growth failure associated with primary igf-1 deficiency (igfd). primary igfd is a term that has been used to describe patients with intrinsic cellular defects in gh action. in this protocol, primary igfd is defined as short stature (height standard deviation score\[sds\]\<-2 below the mean for age and gender), low serum igf-1 (igf-1 sds \<-2 below the mean for age and gender), and levels of growth hormone (gh) that are normal (≥7ng/ml) after a gh stimulation test. primary igfd is believed to result from a lower than normal ability to produce igf-1 when exposed to normal levels of gh, i.e., a type of gh insensitivity or gh resistance. this trial is one year, randomized, open label, observation-controlled, parallel-dose comparison efficacy and safety study conducted in approximately 40 centers across the united states.

Eligibility criteria:
inclusion criteria: * chronological age ≥ 3 and chronological or bone age less than or equal to 11 years inclusive in girls; * chronological age ≥ 3 and chronological or bone age less than or equal to 12 years inclusive for boys * prepubertal * height sd score of \< -2 * igf-1 sd score of \< -2 exclusion criteria: * prior treatment with rhgh, rhigf-1, or other growth-influencing medications * growth failure associated with other identifiable causes (e.g., syndromes, chromosomal abnormality) * chronic illness such as diabetes, cystic fibrosis, etc.

Keywords: primary igf-1 deficiency
fgf-21 and exercise in relation to insulin secretion

Conditions: Physical Activity

Summary: fgf-21 and insulin are key hormones in the regulation of glucose metabolism. furthermore, both hormones are influenced by physical activity. the following hypothesis will be tested: fgf-21 is regulated insulin-dependent during exercise.

type 2 diabetes mellitus (t2dm) is a metabolic disorder characterized by rising global importance. in germany alone, more than seven million people are being treated currently. t2dm is characterized by permanently elevated blood glucose levels, based on insulin resistance and followed by associated beta cell failure. in our previous work the investigators could already shown that increased fgf-21 levels are accompanied by an increased risk of t2dm. physical activity is essential in the treatment and the prevention of t2dm. interestingly, it was shown that acute physical exercise was leading to decreased insulin levels and increased fgf-21 values. in this study the effects of acute physical activity on fgf-21 values should be investigated in 3 groups: a) healthy volunteers b) persons with t2dm c) persons with t1dm.

Eligibility criteria:
inclusion criteria: * healthy volunteers,persons with t2dm, persons with t1dm exclusion criteria: * patients with contraindications to an exercise ecg or spirometry be excluded from participation in the study.
safety, tolerability and efficacy of presbidrops (csf-1) in presbyopic subjects

Conditions: Presbyopia

Summary: a study to establish safety, tolerability, and efficacy of presbidrops (csf-1) in presbyopic subjects.


Eligibility criteria:
inclusion criteria: 1. men and women between 40 and 65 years of age (inclusive) 2. subjects who provide written informed consent to participate in the study 3. subjects have signs of presbyopia upon ophthalmic examination 4. subjects have normal presbyopia with no distance correction or with distance refraction, which is within those limits: sphere between +3 dioptres and -3 dioptres, cylinder no greater than ± 0.75 dc (based on subjective refraction test) 5. subjects must have best corrected vision of at least 20/20 in both eyes, and currently depend on reading glasses or bifocals in which the near addition is \> +1.00 dioptres 6. subjects in general good health in the opinion of the investigator as determined by medical history 7. women with childbearing potential must have a negative urine pregnancy test at screening and be willing and able to use a medically acceptable method of birth control or postmenopausal. acceptable methods of birth control in this study include: vasectomy, tubal ligation, consistent use of an approved oral contraceptive (birth control pill), intrauterine device, hormonal implants, contraceptive injection or a double barrier method (diaphragm with spermicidal gel or condom with contraceptive foam). postmenopausal women are defined as women with menstruation cessation for 12 consecutive months prior to signing of the informed consent form. 8. subjects must be able to understand the requirements of the study and must be willing to comply with the requirements of the study exclusion criteria: 1. history of macular disease or any other ocular conditions or congenital malformation 2. any medical condition known to affect the structure of uvea, cornea, lens or retina or main function of the eyes 3. no cataract or minimal nuclear sclerosis 4. severe dry eye 5. any topical ophthalmic medications, other than artificial tears (up to a maximum of 4 times per day) and medications that are associated with fluctuation of accommodative capacity and/or pupil size, unless on a stable dose for at least 3 months before screening 6. contact lenses for the past three months before the screening visit 7. a difference of more than 0.50 dioptres between the manifest spherical equivalent and the objective refraction spherical equivalent 8. pupil size less than 2.5 mm in either eye prior to dilation at ambient light of 8-15 lux prior to the baseline visit 9. a history of herpes (of any kind) in either eye 10. cataract surgery and/or refractive surgery in either eye 11. known contraindication, hypersensitivity and/or allergy to any study drugs or excipients 12. any acute illness (e.g. acute infection) within 48 hours of first study drug administration, which is considered of significance by the investigator 13. participation in another clinical trial with drugs received within 30 days of screening 14. pregnant or currently lactating women
tavr in adults with pure severe aortic regurgitation

Conditions: Transcatheter Aortic Valve Replacement; Aortic Regurgitation

Summary: the study aimed to evaluate the efficacy and safety of transcatheter aortic valve replacement (tavr) in patients with severe native valve aortic insufficiency. it is a multicentre, observational cohort study. the primary endpoint consisted of a composite of all-cause death, disabling stroke, or rehospitalization for heart failure at 12 months postoperatively. according to previous research results and opinions of expert groups, the sample size was expected to be 76 cases.


Eligibility criteria:
inclusion criteria: * age ≥ 60 years; * patients with severe aortic regurgitation (\> grade 3) diagnosed by transthoracic echocardiography should meet any of the following conditions for semi-quantitative assessment of the degree of aortic regurgitation and any condition for quantitative assessment of the degree of aortic regurgitation: (1) semi-quantitative assessment of the degree of aortic regurgitation: aortic regurgitation bundle width/left ventricular outflow tract diameter ≥ 65%; or aortic regurgitation neck width \> 6 mm; or full-diastolic blood flow reflux in the proximal abdominal aorta; (2) quantitative assessment of the degree of aortic regurgitation: aortic regurgitation volume ≥ 60 ml/beat; or aortic regurgitation fraction ≥ 50%; or effective regurgitation orifice area ≥ 0.3 cm2 * tavr has been performed; * patients can understand and voluntarily participate in this clinical study, sign informed consent, and adhere to clinical follow-up. exclusion criteria: * history of aortic valve replacement; * combined with moderate-severe mitral regurgitation and moderate aortic stenosis; * acute endocarditis or other acute cardiac inflammation; * allergic or contraindicated to related drugs (aspirin, clopidogrel, warfarin, contrast agent); * other conditions judged by the investigator as not suitable for the study

Keywords: transcatheter aortic valve replacement aortic regurgitation observational
changes in cerebral oxygenation during laparoscopy in patients with single ventricle anatomy

Conditions: Congenital Heart Disease; Single Ventricle

Summary: patients with single ventricle physiology (hypoplastic left heart syndrome, tricuspid atresia) frequently have feeding difficulties necessitating procedures such as nissen fundoplication and g-tube placement. with advances in minimally invasive surgery, these are frequently performed using laparoscopic techniques. although generally safe and effective, the increase in iap during laparoscopy may increase systemic and pulmonary vascular resistance and decrease cardiac output. this prospective study will include 50 patients with single ventricle physiology presenting for laparoscopic procedures. there will be no change in the anesthetic or perioperative care of these patients. tissue and cerebral oxygenation will be monitored using near infrared spectroscopy (nirs).


Eligibility criteria:
inclusion criteria: * patients with single ventricle physiology presenting for laparoscopic procedures. exclusion criteria: * none
allergy diagnostic test based on microchip technology

Conditions: Allergy; Allergy;Food; Allergy Pollen; Allergy Drug

Summary: the purpose of this study is to develop a microarray-based diagnostic test system for the determination of allergen specific ige in human blood serum.

the purpose of this study is to develop a microarray-based diagnostic test system for the determination of allergen specific ige in human blood serum samples and to assess the sensitivity and specificity of the developed system.

Eligibility criteria:
inclusion criteria: * type i allergy (food, drug, pollen) * the patient can read, understand, follow the examination procedures and complete, if necessary, the required documentation * written informed consent exclusion criteria: * acute or chronic diseases in the stage of decompensation (except allergy) * chronic infectious diseases: hiv, viral hepatitis b, c, tuberculosis * patients who are pregnant, breastfeeding * chronic and protracted mental disorders, all diseases with the presence of the syndrome of dependence on alcohol, drugs and psychoactive substances, any other condition that makes the patient unable to understand the nature, extent and possible consequences of the study or, in the opinion of the researcher, prevents the patient from observing and performing protocol * patients are unable or unwilling to give written informed consent and / or follow research procedures * any other medical condition that, in the opinion of the investigator, may be associated with an increased risk to the patient or may affect the outcome or evaluation of the study
phase i study of perifosine + lenalidomide and dexamethasone for patients with multiple myeloma

Conditions: Multiple Myeloma

Summary: this is a phase i study of perifosine in combination with lenalidomide and dexamethasone for patients with relapsed or refractory multiple myeloma. the current protocol will enroll patients with relapsed or refractory multiple myeloma requiring second or third line therapy. six patients each will be treated with at one of 4 dose levels in a phase 1 study. all patients will receive perifosine, lenalidomide and dexamethasone of each 28 day cycle. the doses of perifosine and lenalidomide will be varied in each group. the dose of dexamethasone will remain constant.

this is a phase i study of perifosine in combination with lenalidomide and dexamethasone for patients with relapsed or refractory multiple myeloma. all patients will receive lenalidomide daily for days 1 to 21 of each 28 day cycle. perifosine will be given daily qhs with food. dexamethasone will be given on days 1-4, 9-12 and 17-20 for 4 cycles. after 4 cycles dexamethasone will be given only on days 1-4. four dose levels will be studied: 1. perifosine 50 mg, lenalidomide 15 mg and dexamethasone 20 mg 2. perifosine 50 mg, lenalidomide 25 mg and dexamethasone 20 mg 3. perifosine 100 mg, lenalidomide 15 mg and dexamethasone 20 mg 4. perifosine 100 mg, lenalidomide 25 mg and dexamethasone 20 mg six patients will be enrolled at each dose level until the maximum tolerated dose (mtd) is reached. six additional patients will be treated at the mtd.

Eligibility criteria:
inclusion criteria: * subject was previously diagnosed with multiple myeloma based on standard diagnostic criteria, as follows. * major criteria: 1. plasmacytomas on tissue biopsy. 2. bone marrow plasmacytosis (\> 30% plasma cells). 3. monoclonal immunoglobulin spike on serum electrophoresis immunoglobulin g (igg) \>3.5 g/dl or immunoglobulin a (iga) \> 2.0 g/dl; kappa or lambda light chain excretion \> 1 g/day on 24 hour urine protein electrophoresis. * patients must have relapsed or refractory disease (refractory is defined as progression during treatment or within 60 days after the completion of treatment) requiring 2nd or 3rd line therapy * patients refractory to a combination of lenalidomide and dexamethasone will not be eligible. patients may have received lenalidomide and/or dexamethasone exclusion criteria: * renal insufficiency (serum creatinine levels \> 3 mg/dl).. * history of allergic reactions attributed to compounds of similar chemical or biologic composition to perifosine (miltefosine or edelfosine). * known hypersensitivity to thalidomide

Keywords: multiple myeloma perifosine lenalidomide dexamethasone
expectations regarding mobility and self-care

Conditions: Benign Neoplasms; Malignant Neoplasms of Independent (Primary) Multiple Sites

Summary: the goal of this research study is to learn if there is a difference between your expectations of how well you will perform daily living activities after short-term inpatient rehabilitation and the doctor's expectations of how well you will perform daily living activities.

if you agree to take part in this study, you will complete questionnaires before your inpatient rehabilitation and after you complete inpatient rehabilitation. the questionnaires will ask about how well you currently perform daily living activities, your expectation of how well you will perform daily living activities after you complete inpatient rehabilitation, your symptoms in the past 24 hours, and your physical, functional, social, and emotional well-being. these questionnaires should take about 15 minutes total to complete. information from your medical record (such as your age, gender, religion, cancer diagnosis, stage of cancer, and so on) will be collected. length of study: you participation on this study will be over after you complete the questionnaires. this is an investigational study. up to 111 participants will take part in this study. all will be enrolled at md anderson.

Eligibility criteria:
inclusion criteria: 1. participants are willing and able to give written informed consent and to comply with all of the study visits and surveys 2. patients with any type of cancer admitted on the acute inpatient rehabilitation unit who can tolerate 3 hours of rehabilitation therapies per day 3. patients 18 years and older 4. patients must be able to understand, read, write, and speak english. exclusion criteria: 1. patients who have delirium, severe symptom distress, or cognitive impairment. 2. patients who return to primary service prior to discharge from the acute inpatient rehabilitation unit.

Keywords: questionnaires surveys benign neoplasms malignant neoplasms of independent (primary) multiple sites inpatient rehabilitation therapy
treating onychomychosis

Conditions: Onychomycosis

Summary: a study to treat 4 toes at a time to eliminate onychomycosis


Eligibility criteria:
inclusion criteria: * 18 years or older * positive onychomycosis * negative pregnancy exclusion criteria: * peripheral neuropathy
phase ii trial of (il-2) with priming and (gm-csf) in patients with advanced melanoma

Conditions: Malignant Melanoma

Summary: high-dose il-2 treatment for metastatic melanoma has been approved by the fda in 1998. studies of gm-csf plus il-2 have not addressed the approved dose and schedule. this protocol will study the combination of hd-il2 and gm-csf given the potential synergistic interactions discussed above.

the primary objectives of this phase ii multicenter trial are to: determine the 1 and 2-year survival of patients treated according to protocol. assess the safety and toxicity of this regimen in this patient population. the secondary objectives are to: determine the freedom from progression (ffp). measure the response rate (rr). obtain immunological data from the use of this regimen in vivo (as separate project: moffitt?). the proposed study is a multicenter phase ii trial of hd-il-2 in combination with gm-csf. gm-csf will be started 7 days before day 1 of hd-il-2 and will be continued for 4 weeks to day 28, encompassing two cycles of hd-il2. the first 9 patients will be closely monitored for unexpected toxicity.

Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of melanoma with measurable disease * patients with stage iv or unresectable advanced melanoma * age at least 16 years. * ecog performance status of 0-1 * life expectancy \> 3 months * adequate major organ function to tolerate therapy, as defined by: * total bilirubin 2.0 mg/dl. * creatinine 1.8 mg/dl. * wbc 3,000/mm3. * platelet count 100,000/mm3. * patients 50 years of age with one or more cardiac risk factors must demonstrate normal exercise stress test, stress thallium test, or comparable cardiac ischemia evaluation * left ventricular ejection fraction \> 40% * women of childbearing age must agree to use barrier method birth control and demonstrate a negative pregnancy test prior to initiation of protocol therapy. periodic negative urine pregnancy tests will also be required. * patients must give written informed consent exclusion criteria: * no prior hd- il-2 for stage iv/unresectable advanced disease. prior low dose il-2 is allowed. * no more than 2 prior chemotherapy regimens are allowed. * no active cns metastases. treated cns metastases without recurrence or progression for \> 8 weeks are allowed. * no concurrent use of systemic corticosteroids * pregnant and/or lactating are excluded * no concurrent antineoplastic treatments, including chemotherapy, biologic response modifiers, radiation, vaccines, or other experimental therapies. * no treatment for melanoma within the previous 4 weeks.

Keywords: gm-csf interleukin il-2 sargrostim
pre-op chemo-rt w/cddp/5fu vs chemo w/ docetaxel/irinotecan in pet non responder resectable esophagus cancer

Conditions: Carcinoma of Esophagus

Summary: the purpose of this study is to improve their outcome by either changing the chemotherapy drugs or giving them radiation therapy with concurrent chemotherapy, hoping that this will improve their outcome.

this study is aimed at improving the outcome of resectable non pet responders, esophageal carcinoma, by either changing the chemotherapy drugs or giving them radiation therapy with concurrent chemotherapy, hoping that this will improve their outcome.

Eligibility criteria:
inclusion criteria: * histologically proven squamous cell or adenocarcinoma of the thoracic esophagus and gastro-esophageal junction. * no distant metastases. * signed written informed consent. * age less than 75 years. * potentially resectable tumor (radiological evidence of resection with no residual disease). * ecog 0 to 2. * normal serum creatinine and adequate hepatic function, serum bilirubin less than 30 mmol/l, serum alkaline phosphatase less than 2 times upper limit of normal and alt and ast of less than 4 upper limits of normal. * normal bone marrow function with absolute neutrophile count of more than 1500/ml, hemoglobin more than 80 gm/l and platelets more than 100,000 /ml exclusion criteria: 1. serious underlying medical condition which could impair the patient ability to participate in the clinical trial or comply to follow up 2. prior treatment with other anti cancer therapy or radiation therapy. 3. legal incapacity. 4. previous malignancy within 5 years except adequately treated non melanomatous skin cancer or in situ cervical cancer. 5. psychiatric or mental disorder precluding the understanding of the information of the trial topics and giving valid informed consent.

Keywords: randomized trial, pre-operative chemo-rt with cddp and 5-fu multicenter study
effect of sbg in patients with breast cancer

Conditions: Breast Cancer

Summary: this study is set up to determine whether soluble beta-glucan (sbg) has * unfavourable side effects * beneficial treatment effects when given in combination with standard antibody and chemotherapy to patients with breast cancer.


Eligibility criteria:
inclusion criteria: 1. women with histologically/cytologically confirmed locally advanced or metastatic breast cancer 2. primary tumor or metastases are her2-ich3+ or fish+ 3. measurable or non-measurable disease 4. the patients must not have received treatment with the combination trastuzumab and vinorelbine previously 5. expected lifetime of more than 12 weeks 6. age ≥ 18 years 7. performance status ≤ 2 according to world health organization (who) scale 8. the patient must be able to comply with the protocol 9. verbal and written informed consent exclusion criteria: 1. women who are pregnant or breast-feeding. a negative pregnancy test must be provided during the screening period for fertile women. fertile women must use effective contraceptive methods 2. clinical symptoms indicating central nervous system involvement 3. other current or former malignant disease, with the exception of adequately treated and cured carcinoma in situ cervicis uteri and basocellular skin carcinomas 4. left ventricular ejection fraction (lvef) \< 50% of normal range 5. reduced bone marrow function defined by leukocyte counts \< 3.0 x 109/l and neutrophil counts \< 1.5 x 109/l, or thrombocyte counts ≤ 100 x 109/l 6. reduced liver function defined by bilirubin \> 3 x upper normal limit and/or asat/alat \> 3 x upper normal limit and/or alkaline phosphatase \> 3 x upper normal limit. 7. reduced renal function defined by serum creatinine \> 2 x upper normal limit
translation of the sydney swallow questionnaire and validation of the german version

Conditions: Dysphagia

Summary: translation of a validated questionnaire (ssq) from english to german and validation of the german version. the ssq consists of 17 well-structured questions for the assessment and quantification of patient reported difficulties in swallowing function. the tool is specifically designed to evaluate important aspects of swallowing function the questions cover the symptoms related to combinations of variables like the anatomic region, type of dysfunction, and the consistency of swallowed bolus.


Eligibility criteria:
inclusion criteria: - patients with diagnosed dysphagia "of any causes" * sufficient proficiency in german * voluntary participation exclusion criteria: - insufficient knowledge of the german language * cognitive limitations * reduced general state of health

Keywords: dysphagia, swallowing functions, questionnaire in german