Kornimate/medical-research-clean huggingface dataset:
effect of hsa or saline diluent on immunotherapy extract stability as determined by graded id skin tests

Conditions: Allergic Rhinitis

Summary: this is a double-blind study with respect to the diluents used, with patients known to be allergic to the specific allergen tested. three study sites will be involved, each testing one allergen (cat, mite, timothy grass pollen). subjects who are known to be allergic to the allergen in question will be tested with serial three-fold dilutions to determine the id 50 and relative extract potency using the method described by turkeltaub.

the specific objective of this study is to determine the stability of immunotherapy extract dilutions. higher dilutions (lower potency) have been shown in vitro to decrease in potency over time more rapidly than less dilute preparations. the investigators hope to determine whether there is a detectable difference in skin test reaction of dilutions of three common antigens (cat, timothy grass, dust mite). the diluents used strongly affect the strength when extract potency is tested in vitro. therefore, the investigators expect to find a detectable difference in skin test potency based on the diluents used (saline vs. hsa saline \[300mcg/ml\]).

Eligibility criteria:
inclusion criteria: * 1. subjects must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent. 2. subjects of either gender, ages 18-60 years, with a history of allergic rhinitis related to exposure to the allergen of interest. 3. previous positive routine skin test to the allergen to be tested: minimum 5mm wheal diameter with 10,000bau/ml cat or minimum 5mm wheal diameter with 10,000au/ml dermatophagoides farinae or minimum 8mm wheal diameter with timothy 100,000bau/ml. 4. and (in addition to #3) sum of erythema after spt of at least 50mm or erythema in largest diameter of at least 30mm. 5. subject's skin coloring should permit evaluation of erythema. 6. ability to stop medication that might interfere with the results of the skin prick test. exclusion criteria: - 1. spirometry with fev1 below 80% of predicted normal value and/or poorly controlled asthma 2. known pregnancy 3. patients with a history of anaphylaxis or severe allergic reactions. 4. patients with absolute necessity of antihistamines to control their allergies 5. patients with active and extensive atopic dermatitis. 6. patients that take psychotropic medication. 7. general skin hyperreactivity (negative control greater than 3 mm wheal diameter) or with known tendency for dermatographic urticaria. 8. patients currently under allergen immunotherapy treatment or with a history of immunotherapy treatment within the last 5 years to the extract to be tested in this study

Keywords: diluent rhinitis allergic
a phase iii study of a 2-dose regimen of a multivalent human papillomavirus (hpv) vaccine (v503), administered to 9 to 14 year-olds and compared to young women, 16 to 26 years old (v503-010)

Conditions: Human Papillomavirus Infection

Summary: this was a 37-month safety and immunogenicity study conducted in boys and girls 9 to 14 years of age and in young women 16 to 26 years of age. from this study, the goal was to establish that the investigational 2-dose regimens (0, 6 months and 0, 12 months) studied in boys and girls 9 to 14 years of age are generally safe and immunogenic, with an antibody response that is not inferior to that observed in young women 16 to 26 years of age who received the standard 3-dose regimen of v503 (i.e., the population and dose regimen used to establish v503 efficacy).


Eligibility criteria:
inclusion criteria: all participants: -judged to be in good physical health on the basis of medical history, physical examination and laboratory results boys and girls 9 to 14 years: -must not have had coitarche and does not plan on becoming sexually active during the vaccination period women 16 to 26 years: * has never had a papanicolaou (pap) test or only had normal pap test results * a lifetime history of 0 to 4 male and/or female sexual partners exclusion criteria: all participants: * known allergy to any vaccine component * history of severe allergic reaction that required medical intervention * thrombocytopenia or any coagulation disorder * females only: participant is pregnant or expecting to donate eggs during day 1 through month 7 * currently immunocompromised, or been diagnosed with immunodeficiency * had a splenectomy * receiving or has received immunosuppressive therapies within the last year * received any immunoglobulin product or blood-derived product within 3 months * received a marketed hpv vaccine or has participated in an hpv vaccine clinical trial
gleevec/low-dose ara-c study for elderly patients with aml and myelodysplastic syndromes

Conditions: Leukemia, Myeloid; Myelodysplastic Syndromes

Summary: the goal of this clinical research study is to learn if the combination of gleevec (imatinib mesylate) and low doses of cytarabine (ara-c) may help to control leukemia while causing fewer side effects than standard high dose chemotherapy.

imatinib mesylate is a drug that blocks a certain protein. this protein is thought to be important in the growth of leukemia cells. ara-c is a chemotherapy drug that has been used for many years to treat aml and mds. imatinib mesylate (gleevec) is a protein-tyrosine kinase inhibitor that inhibits the bcr-abl tyrosine kinase, as well as the receptor tyrosine kinases for platelet- derived growth factor (pdgf) and stem cell factor (scf), c-kit, and inhibits pdgf- and scf-mediated cellular events. c-kit is expressed in over 90% of patients with aml. the treatment of aml for patients age 65 or older with aml or high-risk mds (age ³ 60 if high-risk cytogenetics) have a poor prognosis with induction chemotherapy. response rate is no more than 45% with an induction mortality of at least 25%, and 1-year survival no better than 20%. indeed, most patients in these age groups are not even offered therapy and are managed with supportive care only. thus, new therapies that are better tolerated are needed. imatinib alone can induce response in nearly 20% of patients, and there is synergy with low concentrations of ara-c. in this study we plan to investigate the combination of imatinib and low-dose ara-c.

Eligibility criteria:
inclusion criteria: * patients who are not candidates for intensive chemotherapy with any of the following diagnosis: 1. aml or mds (with \>/=5% blasts) age \>/= 65 years old (or age \>/= 60 if high-risk cytogenetics), or 2. aml or mds (raeb or raebt) of any cytogenetic group age 60 or older with minimally treated disease who have relapsed disease or are refractory to therapy and not likely to require cytoreductive therapy within one month, and, or 3. cmml. * patients with who performance status of 0 to 2 * patients must have recovered from prior cytotoxic chemotherapy; treatment with hydrea is allowed up to 24 hours prior to day 1 of study drug administration * written informed consent obtained according to local guidelines * patients must have a serum creatinine of \</= 1.5 x uln, sgpt \</= 3 x uln and total bilirubin \</= 2.0 x uln. * patients with \>/= 20% blasts positive for c-kit (cd117) (except for cmml) * postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. male and female patients of childbearing potential must agree to employ an effective method of birth control throughout the study and for up to 3 months following discontinuation of study drug. exclusion criteria: * patients with uncontrolled active infection * patients with nyha class iii or iv * women who are pregnant * women who are breast feeding

Keywords: aml mds gleevec ara-c c-kit positive acute myeloid leukemia high-risk myelodysplastic syndromes
tracking the brain in myotonic dystrophies: a 5-year longitudinal follow-up study

Conditions: Myotonic Dystrophy 1; Myotonic Dystrophy 2

Summary: the natural history of brain affection in myotonic dystrophy types 1 and 2 is still unknown. the investigators designed a 5-year longitudinal neuropsychological and neuroimaging follow-up study to address this issue. myotonic dystrophy type 1, myotonic dystrophy type 2 patients, and healthy controls were enrolled. all participants undergo clinical-neurological examinations, neuropsychological analyses according to a 13-item neuropsychological test battery, and 3t-brain mri including voxel-based morphometry and diffusion tensor imaging at baseline and at follow-up using identical examination protocols.

it is unknown whether brain affection in myotonic dystrophy types 1 and 2 is due to neurodevelopmental defects, neurodegeneration, or both. an exact definition of the nature and dynamic of brain affection is of urgent need for the identification of clinical trial outcome parameters and the design of therapy compounds. the investigators planned a 5-year longitudinal study to examine the natural history of functional and structural brain affection. myotonic dystrophy type 1, myotonic dystrophy type 2 patients, and healthy controls were enrolled. all participants undergo clinical-neurological examinations, neuropsychological analyses according to a 13-item neuropsychological test battery, and 3t-brain mri at baseline and at follow-up using identical examination protocols. the intended time span between baseline and follow-up examinations is 5 years minimum. to investigate gray and white matter affection, voxel-based morphometry and diffusion tensor imaging are performed, and data are statistically analyzed including (i) group comparisons between patients and controls at baseline and follow-up, and (ii) group comparisons using difference maps to focus on isolated disease-related effects over time.

Eligibility criteria:
inclusion criteria for healthy controls: * written informed consent * normal neurological examination without any acute or former neurological or severe psychiatric disease, no medical history of traumatic brain injury inclusion criteria for patients: * written informed consent * diagnosis confirmed by genetic testing * no other neurological or severe psychiatric disease, no medical history of traumatic brain injury exclusion criteria for healthy controls and patients: * use of psychoactive substances including alcohol (except nicotine), formerly or currently; treatment with modafinil * severe psychiatric disorders, serious physical illnesses, particularly cardiovascular diseases, formerly or currently * non-removable ferromagnetic metallic implants, sensors, stimulators, prostheses, pacemaker, large tattoos * claustrophobia * age under 18 years

Keywords: neuromuscular disorders mri white matter brain myotonic dystrophy
one year of velocity-based resistance training in older people living in nursing homes

Conditions: Aging; Muscle Mass and Strength; Muscle Power; Frailty Syndrome; Cognitive Function

Summary: this study is an exercise intervention assessing the efficacy of a velocity-based resistance training (vbrt) in institutionalized older adults. the aim of this study is to assess the effects of one year of velocity-based resistance training on skeletal muscle mass, muscle function, and physical and cognitive function in older adults living in nursing homes.

evidence supports the fact that resistance exercise training is effective in improving old adult's health and palliate age-related disorders. new approaches in resistance training are emerging to maximize monitoring control, providing more tailored and potentially more effective exercise interventions. among them, the velocity-based resistance training (vbrt) is being established in healthy populations or populations with pathologies. however, the effects of long-term vbrt in institutionalized older adults are still unknown. thus, the aim of this study is to assess the effects of one year of velocity-based resistance training on skeletal muscle mass, muscle function, and physical and cognitive function in older adults living in nursing homes.

Eligibility criteria:
inclusion criteria: * older people living permanently in nursing home. * age ≥ 65 years old. * are able to walk with/without assistance. * have ability to communicate with the research team. exclusion criteria: * terminal illness. * any illness not controled (cardiac, pulmonary, etc). * if there is a risk of bone fracture according to medical staff.
effect of smoking on activated clotting time values during coronarography and angioplasty

Conditions: Ischemic Cardiomyopathy

Summary: analyzing influence of smoking on patients anti-coagulation status as assessed by act measurements during coronary angioplasty

during angioplasty, activated clotting time (act) measurements are recommended to attest the correct anticoagulation level and if anticoagulation levels are suboptimal after the two first boluses, additional unfractionated heparin (ufh) injections are recommended until obtention of a therapeutic act values (250-350s). the study hypothesis was that the procoagulant effect of the tobacco may be responsible of reduced anticoagulation levels after standardized ufh administrations and thus presenting an ufh resistance requiring increased ufh dosages to obtain a therapeutic act values.

Eligibility criteria:
inclusion criteria: * any patient older than 18 years needing a diagnostic coronarography was eligible for enrollment exclusion criteria: * unconscious patient * any patient presenting with one of the following characteristic known to impact either on act or aptt measurements as: oral anticoagulation medication (anti-vitamin k and non-vitamin k antagonist oral anticoagulants \[noac\]), fondaparinux or lmwh usage, coagulopathy defined as prothrombin time \ 1.2 presence of lupus anticoagulant, connective tissue disease, active cancer * a person as defined by the law articles l. 1121-5, l. 1121-7 et l1121-8 of the code de la santé publique, france (pregnant, parturient women or breastfeeding women, legally adult patient under legal protection measure \[tutelage, protection of vulnerable adults\]), * a person as defined by the law articles l. 3212-1 et l. 3213-1 of the code de la santé publique, france (legally adult patient unable to consent, person with legal or administrative freedom restriction or person under psychiatric treatment)
hemfitbit, an observational study of physical activity in people with moderate and severe haemophilia a

Conditions: Hemophilia A Without Inhibitor

Summary: the study aims to describe physical activity (pa) levels in young people with haemophilia a in norway compared with non-haemophilia controls, and to identify factors influencing pa. this will be conducted through an observational study measuring pa over 12 weeks. forty young people with moderate and severe haemophilia a will be enrolled. pa data will be compared to demographically and seasonally matched non-haemophilia controls. pa will be measured using the activity tracker fitbit charge 3. a subgroup of participants will also wear the hip-worn accelerometer actigraph gtx+bt for seven consecutive days in order to validate the two devices against each other.


Eligibility criteria:
inclusion criteria: * moderate or severe haemophilia a * no inhibitor * on continuous prophylaxis exclusion criteria: * current inhibitor
spectral analysis of bowel sounds in preterm babies of less than 32 weeks of amenorrhea (wa) as predictive factor of enterocolitis

Conditions: Bowel Sounds; Spectral Analysis; Necrotizing Enterocolitis; Preterm Babies

Summary: the recording or bowels is easy and cheap. the investigators wonder if these sounds are modified in babies with high risk of necrotizing enterocolitis. in this study, the investigators suggest to record and do a spectral analysis of 30 seconds of bowel sounds in preterm babies of less than 32wa before and after enteral nutrition, every day until the end of hospitalization. a spectral analysis will be made for each record to determine frequencies of the signal. the investigators will try to determine physiological frequencies and look for modifications in pathological situations.


Eligibility criteria:
inclusion criteria: * preterm babies of less than 32wa exclusion criteria: * preterm babies of more than 32wa, * digestive congenital malformation

Keywords: bowel sounds spectral analysis necrotizing enterocolitis preterm babies
artificial intelligence to measure adherence to oral medication

Conditions: First Episode Psychosis

Summary: the aims of this project is to use an artificial intelligence (ai) smartphone app to provide support for medication adherence by patients with first episode psychosis.

the challenge of oral medication adherence in first-episode psychosis (as in any potentially chronic illness) is enormous, and numerous studies have linked non-adherence to increased rates of relapse/ hospitalization. determining whether a patient is adhering to medication is a challenge. pill counts, pharmacy records, technology-assisted monitoring, biological assays, and a range of self-report and interviewer-rated scales have been employed. in other areas of medicine such as antiretroviral treatment direct observation of treatment (dot) has been employed with excellent success both in monitoring and demonstrated improvement of important clinical outcomes. dot is clearly not feasible in community settings. an artificial intelligence (ai) platform that can be downloaded as an application onto a smart phone app represents a novel approach to offering dot to support participant oral medication adherence and thereby improve outcomes. aims of the project are: 1) to document acceptability to patients of the ai smartphone app based upon participation in the study and 2) to compare rates of hospitalization and emergency room visits between participants who receive the ai smartphone app with participants who receive standard care.

Eligibility criteria:
inclusion criteria: * enrolled in a csc program * prescribed an oral antipsychotic exclusion criteria: * none
effects of baby massage on parenting stress and attachment in premature

Conditions: Premature Birth

Summary: this study is an experimental randomized controlled clinical trial. to explore the effect of infant massage on parental pressure and parent-child attachment of premature infants. the intervention time was from 5 days after birth to discharge from premature infants. data were collected at five time points in longitudinal, before massage (t0), one week (t1), four weeks (t2), and eight weeks ( t3), 12 weeks (t4). parents in the experimental group were given massage interventions when visiting premature babies, while parents in the control group visited premature babies as usual and contacted premature babies according to general nursing instructions.

the organ development of premature infants is not yet mature, leading to higher morbidity and mortality. even with advanced technology, parents and families still need to put more effort into taking care of these premature babies so that they can survive. empirical evidence indicates that baby massage can help parents reduce stress and establish parent-child relationships, but few studies have been applied to parents of premature babies during hospitalization. based on this, the purpose of this study is: 1. to explore the effect of infant massage on reducing parental pressure; 2. to compare the gender differences of parental pressure; 3. to explore the effect of infant massage on parent-child attachment; 4. compare the gender difference of parent-child attachment relationship between parents of premature infants. an experimental randomized controlled clinical trial study design was adopted to collect data at five points in time, namely before massage (t0), one week (t1), four weeks (t2), eight weeks (t3), and 12 weeks (t4 ). using the parental stress scale and parent-child attachment scale. parents in the experimental group were given massage interventions when visiting premature babies, while parents in the control group were routinely visiting premature babies. the effects of infant massage on parental pressure and parent-child attachment of premature babies at different time points were discussed, and the differences gender of parental pressure and parent-child attachment were compared. the results can increase the empirical research on baby massage, use the empirical knowledge to arouse the attention of nursing staff to baby massage, improve the quality of family-centered care, and pay attention to the needs of parents of different genders.

Eligibility criteria:
inclusion criteria: 1. single premature infants with a birth week of 30-37 weeks, weighing 1500-2500 grams; 2. the pediatrician assesses the stability of vital signs; 3. premature infants without congenital abnormalities (such as congenital heart disease) or central nervous system dysfunction (such as intraventricular hemorrhage, epilepsy, etc.); parents who meet the conditions for premature infants are the study subjects. exclusion criteria: 1. parents performing kangaroo care; 2. parents younger than 20 years of age; 3. parents with mental illness or substance abuse; 4. single parent father or mother.
a clinical trial of docetaxel and oxaliplatin in patients with recurrent or metastatic breast cancer

Conditions: Recurrent Breast Cancer; Metastatic Breast Cancer

Summary: the purpose of this study is to evaluate the overall response rate, toxicity, progression free survival and quality of life of chemotherapy with docetaxel and oxaliplatin in recurrent or metastatic breast cancer.

recent therapeutic developments, such as the introduction of new cytotoxic agents (taxanes, platinum, liposomal anthracyclines, etc) have resulted in constant improvements in treatment efficacy and consequently in recurrent or metastatic outcome. this single arm, multicenter phase ii study was designed to evaluate the response rate, toxicity, progression free survival of docetaxel and oxaliplatin in patients with recurrence or metastatic breast cancer.

Eligibility criteria:
inclusion criteria: 1. women aged : 20\~70 years 2. who (ecog) performance status 0-2 3. patients with measurable lesion assessed by imaging using the recist (response evaluation criteria in solid tumor) guideline 4. patients had previously not received chemotherapy of recurrent or metastatic lesion. 5. have given written informed consent and are available for prolonged follow-up exclusion criteria: 1. patients with previous chemotherapy for recurrent breast cancer 2. breast cancer recurrence within 12 months after taxane treatment 3. her-2/neu expression breast cancer 4. patients with malignancies (other than breast cancer) within the last 5 years, except for adequately treated in situ carcinoma of the cervix or basal cell, squamous cell carcinoma of the skin. 5. brain metastasis 6. uncontrolled infection, medically uncontrollable heart disease 7. other serious medical illness or prior malignancies 8. pregnant or lactating women were excluded.

Keywords: recurrent breast cancer metastatic breast cancer docetaxel oxaliplatin