Kornimate/medical-research-clean huggingface dataset:
safety and immunogenicity of a commercially available influenza vaccine (formulation 2006/2007) when administered to elderly subjects

Conditions: Influenza

Summary: to evaluate the antibody response to each influenza vaccine antigen when administering a single dose to subjects aged 65 years and over


Eligibility criteria:
inclusion criteria: * 65 years of age or older exclusion criteria: * any serious disease such as cancer, autoimmune disease, advanced arteriosclerotic disease or complicated diabetes mellitus, chronic obstructive pulmonary disease (copd) that requires oxygen therapy, acute or progressive hepatic disease, acute or progressive renal disease, congestive heart failure and bleeding diathesis or conditions associated with prolonged bleeding time * hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the vaccine - - history of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine * known or suspected (or high risk of developing) impairment/alteration of immune function within the past 7 days * any acute disease or infections requiring systemic antibiotic or antiviral therapy fever within the past 3 days

Keywords: adjuvanted influenza vaccine
effect of brisk walking on primary dysmenorrhea

Conditions: Dysmenorrhea Primary

Summary: dysmenorrhea is a common problem in women. exercise is commonly cited as a possible remedy. we will measure the effect of brisk walking on primary dysmenorrhea among medical students.


Eligibility criteria:
inclusion criteria: * bmi: 18-25 * regular menstrual cycles exclusion criteria: * marriage or previous sexual activity * medical disorders * previous abdominal or pelvic surgery * skeletal disorders * hormonal or psychiatric treatment * atheletes
peripheral blood biomarkers in idiopathic interstitial pneumonias

Conditions: Idiopathic Interstitial Pneumonias

Summary: we hypothesize that a peripheral blood biomarker or biological signature (gene or protein expression pattern) of idiopathic interstitial pneumonias (iips) will simplify and improve the accuracy of diagnosis of iip and diagnose individuals at an earlier, more treatable, stage of their disease.

the broad challenge area addressed in this proposal is (03) biomarker discovery and validation, and the specific challenge topic is 03-hl-101 (identify and validate clinically relevant, quantifiable biomarkers of diagnostic and therapeutic responses for blood, vascular, cardiac, and respiratory tract dysfunction). idiopathic interstitial pneumonia (iip) is a lung disease(s) that primarily affects the elderly, but is present in all age groups. iip causes respiratory insufficiency and is often fatal. in about half of the patients, the diagnosis requires an invasive lung biopsy which can cause complications, and is not always accurate. the current diagnostic tools for iip are inadequate. in addition to inaccurate diagnosis, they are very costly, and often result in delayed diagnosis and treatment. the challenge(s) we intend to address in this proposal is to improve the accurate and early diagnosis of idiopathic interstitial lung pneumonia (iip), and to improve the ability to differentiate the subtypes of idiopathic interstitial pneumonias (iips) by developing peripheral blood biomarkers.

Eligibility criteria:
inclusion criteria: * sporadic cases of idiopathic pulmonary fibrosis and other types of idiopathic interstitial pneumonias. * family members ( with or without clinical disease) with a family history of pulmonary fibrosis. exclusion criteria: * none.
moderately preterm infants with caffeine at home for apnea (mocha) trial

Conditions: Apnea of Prematurity

Summary: the objective of this study is to evaluate the effect of continuing treatment with caffeine citrate in the hospital and at home in moderately preterm infants with resolved apnea of prematurity on days of hospitalization after randomization.

study subjects will be patients in the nicu at one of the participating hospitals at a neonatal research network site. infants who meet the eligibility criteria will be randomized to either caffeine citrate at 10 mg/kg/dose or placebo (equal volume of all the excipients except for the active ingredient, caffeine citrate) to be given daily beginning within 72 hours of open label caffeine discontinuation. the infant may still require hospitalization for observation after discontinuation of open label caffeine or for other discharge issues such as temperature control or feeding tolerance. once deemed ready for discharge, infants will be continued at home on the same dose of caffeine citrate or placebo for the first 28 days after hospital discharge. on the day of discharge, the parent will be supplied with 28 numbered vials with oral caffeine citrate (intervention group) or placebo at an equivalent volume (placebo group). the parents will be educated by the research nurse, discharge nurse, physician, or pharmacist on storage and administration of study medication. a member of the research team will contact the parents to obtain post-discharge information within 72 hours after discharge, once a week for the first 4 weeks, and biweekly during the weeks 5 to 8 after discharge.

Eligibility criteria:
inclusion criteria: * inborn and outborn infants of 29 0/7 to 33 6/7 weeks gestational age at birth * admitted to hospitals of the nichd nrn who, are at time of enrollment: * ≤35 6/7 weeks post-menstrual age at the time of randomization * receiving caffeine with plan to discontinue treatment or just discontinued caffeine treatment * receiving feeds at a volume of ≥120 ml/kg/day by oral and/or tube feeding * ability to start study medication within 72 hours after stopping caffeine exclusion criteria: * on respiratory therapy (oxygen more than room air equivalent for high altitude sites, nasal cannula, continuous positive pressure ventilation, and/or mechanical ventilation) * infants who would otherwise be discharged home on apnea monitor due to underlying disease or family history, including history of a sibling with sudden infant death syndrome * parental request for apnea monitor * congenital heart disease other than atrial septal defect, ventricular septal defect, or patent ductus arteriosus * neuromuscular conditions affecting respiration * major congenital malformation and/or genetic disorder * plans to transfer to a non-nrn site before discharge * unable to obtain parental or guardian consent

Keywords: moderate preterm infant caffeine citrate
ptcy and and ruxolitinib for gvhd prophylaxis after hsct with thymoglobulin in conditioning regimen in patients with inborn errors of immunity

Conditions: Inborn Errors of Immunity

Summary: the aim of the current study is to evaluate the efficacy of combined regimen of gvhd prophylaxis with thymoglobulin in conditioning regimen and ptcy with ruxolitinib used after hsct in patients with inborn errors of immunity (iei)

hematopoietic stem cell transplantation (hsct) is widely used in inborn errors of immunity (iei), and risks of graft-versus-host disease (gvhd) remain high. use of post-transplant cyclophosphamide (ptcy) for gvhd prophylaxis revolutionized the outcomes of hsct from mismatched related donor (mmrd). use of ruxolitinib for gvhd prophylaxis demonstrates promising results in adult patients. another well-known option for gvhd prevention is antithymocyte globulin. to evaluate the efficacy of combination of thymoglobulin with ptcy and ruxolitinib for gvhd prophylaxis, conditioning regimen containing treosulfan 30-42 g/m2, fludarabine 150 mg/mg, and thiotepa 10 mg/kg or melphalan 140 mg/m2 and gvhd prophylaxis regimen containing cyclophosphamide 50 mg/kg for mmrd, 25 mg/kg for matched unrelated and related donors at days +3, 4 post-hsct and ruxolitinib at dose 7 mg/m2 from day +5 after hsct will be used in patients with iei.

Eligibility criteria:
inclusion criteria: 1. patients aged ≥ 0 months and \< 21 years 2. patients diagnosed with nbs eligible for an allogeneic hsct 3. signed written informed consent signed by a parent or legal guardian exclusion criteria: concomitant severe somatic disease associated with an additional risk of severe complications
bpdo-1603 intervention trial in patients with moderate-to-severe alzheimer's disease

Conditions: Moderate-to-severe Alzheimer's Disease

Summary: a multicenter, randomized, double-blind, active-controlled, phase iii clinical trial to evaluate the efficacy and safety of bpdo-1603 in patients with moderate-to-severe alzheimer's disease


Eligibility criteria:
inclusion criteria: * a voluntary, written informed consent from the patient or the patient´s representative. * male or female patients ≥ 45 years of age as of the date of informed consent. * diagnosed with probable ad according to the national institute on aging-alzheimer's association \[nia-aa (2011)\] criteria. * mmse score of ≥ 5 and ≤ 20 during screening period. * cdr-gs of 2 \~ 3 or gds of 4 \~ 7 during screening period. * ongoing cholinesterase inhibitor therapy with stable dose of 10 mg/day donepezil hydrochloride for more than 12 weeks (inclusive) prior to screening, and can continue this therapy until randomization without any change in the dosage regimen of donepezil hydrochloride. exclusion criteria: * magnetic resonance imaging (mri) or computed tomography (ct) findings obtained within the past 12 months (ie, 48 weeks) from screening or at screening, as a cause of dementia other than probable ad. * history of other organic disease, such as vascular dementia, cns infections (e.g., human immunodeficiency virus \[hiv\], syphilis), head injury, creutzfeldt-jakob disease, niemann-pick's disease, huntington's disease, parkinson's disease, epilepsy, or stroke. * evidence of other neurological disorders which include seizure disorder that may interfere with the patient's cognition or ability to perform the study procedures. * use of memantine hydrochloride within 1 month prior to screening
safety, tolerability study of sg2000 in the treatment of advanced chronic lymphocytic leukemia and acute myeloid leukemia

Conditions: Acute Myeloid Leukemia; Chronic Lymphocytic Leukemia

Summary: the purpose of this study is to determine if the experimental drug, sg2000 is safe and tolerable in the treatment of participants with advanced chronic lymphocytic leukemia and acute myeloid leukemia whose standard treatment did not work, whose cancer came back or who are not candidates for other types of standard therapy.


Eligibility criteria:
inclusion criteria: * male or female greater than or equal to 18 years of age * have one of the following disease states: acute myeloid leukemia (aml) (age \<60 years) with relapsed/refractory disease; •chronic lymphocytic leukemia (cll) with relapsed disease following a fludarabine-based regimen or relapsed disease following an alkylator-based regimen * are recovered from the acute adverse effects of prior therapies (excluding alopecia and grade ≤2 neuropathy). * have blast counts that can be controlled by the use of hydroxycarbamide (500 to 3000 mg daily). * have adequate hepatic function and renal function * have an estimated life expectancy of \>3 months * female subject must have a negative serum pregnancy result within 7 days before the start of the study; both men and women must agree to use a medically acceptable form of contraception throughout the treatment period and for 3 months after discontinuation of treatment exclusion criteria: * are eligible for any standard therapy known to be life prolonging or life saving * have diagnosis of aml french-american-british (fab) classification (fab) m3 (acute promyelocytic leukemia (apl)) * are receiving concurrent chemotherapy, radiotherapy, immunotherapy, biological or hormonal treatment for cancer. * have undergone anticancer therapy including chemotherapy (except for hydroxycarbamide at a maximum daily dose of 3000 mg), endocrine therapy, immunotherapy, or the use of other investigational agents within 4 weeks before study entry. * prior radiation therapy with volume of bone marrow treated over 25%. * use of immunosuppressive therapy, including systemic steroids within 7 days before the first dose of sg2000. * hyperleukocytosis (blast counts \>30 000/mm3). * history of allogeneic stem cell or solid organ transplantation. * positive serology for human immunodeficiency virus (hiv), hepatitis b or hepatitis c or have hiv-aids, or active hepatitis b or c. * history of other invasive malignancy within 3 years except for cervical carcinoma in situ, nonmelanomatous carcinoma of the skin or ductal carcinoma in situ of the breast that has been surgically cured. * have any coexisting medical condition that will substantially increase the risk associated with the subject's participation in the study. * have psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or completion of necessary studies. * have persistent grade 2 or greater toxicities from any cause (except alopecia or peripheral neuropathy). * are pregnant or breast-feeding.

Keywords: leukemia
the effect of virtual reality glasses on pain and anxiety during the kidney stone lithotripsy procedure

Conditions: Pain Management; Extracorporeal Shock Wave Lithotripsy; Virtual Reality

Summary: to determine the pain and anxiety levels of patients using virtual reality glasses during the extracorporeal shock wave lithotripsy procedure.

this randomized clinical trial included 60 patients with lithotripsy procedure. the research group of 60 people was divided into two groups, 30 in the experimental group and 30 in the control group. while the standard stone crushing process was applied to the control group, the experimental group was watched with virtual reality glasses during the procedure. the state-trait anxiety inventory and the numerical rating scale, which was used to measure the level of pain and anxiety level.

Eligibility criteria:
inclusion criteria - performing eswl procedure exclusion criteria * presence of psychiatric disease * vision problem * hearing problem * drug and alcohol addiction

Keywords: extracorporeal shock wave lithotripsy pain virtual reality anxiety
safety and efficacy of carboxymethylcellulose for ocular surface integrity in symptomatic dry eye

Conditions: Dry Eye Syndromes; Keratoconjunctivitis Sicca

Summary: this study will evaluate the safety and efficacy of optive® md for ocular surface integrity in symptomatic dry eye condition in absence of obvious eye-lid inflammation.


Eligibility criteria:
inclusion criteria: * have been using artificial tears for at least 3 months prior to study inclusion * have been using preservative free artificial tears at least three times daily (tib) for at least 2 weeks immediately prior to study inclusion * having moderate to severe symptoms suggestive of dry eye exclusion criteria: * current enrollment in an investigational drug or device study or participation in such a study within 3 months prior to entry into this study * moderate to severe blepharitis * history or active signs of ocular trauma, ocular infection, or ocular inflammation within the last 3 months * history or active signs of ocular allergic disease or ocular herpes within the last year * history or active signs of severe or serious ocular conditions such as inflammatory corneal ulcers, recurrent erosions, and uveitis at any time.
a study to evaluate the effectiveness, safety, and tolerability of canagliflozin in combination with metformin in the treatment of patients with type 2 diabetes mellitus with inadequate glycemic control with diet and exercise

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this study is to assess the effectiveness of the co-administration of canagliflozin and metformin extended release (xr) compared with canagliflozin alone, and metformin xr alone in patients with type 2 diabetes mellitus with inadequate control despite treatment with diet and exercise. the safety and tolerability of canagliflozin will also be assessed.

this study will be a randomized (the study medication is assigned by chance), double-blind (neither physician nor participant knows the identity of the assigned treatment), active-controlled (one of the treatments is an established effective treatment for type 2 diabetes mellitus), parallel-group (each group of participants will be treated at the same time), 5-arm (groups), multicenter study. approximately 1,200 participants will be randomly assigned to the 5 treatment arms in a 1:1:1:1:1 ratio for 26 weeks.

Eligibility criteria:
inclusion criteria: * must have type 2 diabetes mellitus with inadequate glycemic control on diet and exercise * not on antihyperglycemic agent therapy (at least 12 weeks before screening) and have a screening visit fingerstick glycated hemoglobin (hba1c) of more than or equal to 7 percent and less than or equal to 12.5 percent * have a screening visit hba1c of more than or equal to 7.5 percent and less than or equal to 12 percent as determined by the central laboratory * must have a fasting plasma glucose of less than or equal to 300 mg/dl (16.7 mmol/l) prior to randomization * must have a fasting fingerstick glucose of greater than 120 mg/dl (6.7 mmol/l) performed at home or at the study center prior to randomization exclusion criteria: * history of diabetic ketoacidosis, type 1 diabetes mellitus (t1dm), pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy * fasting c-peptide less than 0.70 ng/ml (0.23 nmol/l) in participants for whom the investigator cannot reasonably exclude t1dm based upon clinical evaluation * repeated (2 or more over a 1 week period) fasting self-monitored blood glucose measurements more than 300 mg/dl (16.7 mmol/l) prior to randomization, despite reinforcement of diet and exercise counseling * history of hereditary glucose-galactose malabsorption or primary renal glucosuria * has history of, or currently active, illness considered to be clinically significant by the investigator or any other illness that the investigator considers should exclude the patient from the study or that could interfere with the interpretation of the study results

Keywords: diabetes mellitus, type 2 diabetes mellitus canagliflozin (jnj-28431754) metformin
effects of directional subthalamic deep brain stimulation on gait and balance in parkinson's disease patients

Conditions: Parkinson Disease

Summary: deep brain stimulation of the nst is effective for cardinal motor signs in patients with idiopathic parkinson's disease (ipd), its effects on gait disturbances, especially freezing of gait-fog, and falls are variable from one patient to another, in part depending on the location of the nst-stimulating contact. the ability to change the shape of the current field, and thus the volume of activated tissue, with a directional stimulation electrode is a new treatment option for nsc scp patients with parkinson's disease. in this pilot research program, the main objective is to determine the impact of directional dbs on gait and balance issues for pd patients implanted in the stn, using previously described anatomical and functional data for gait disturbances to guide directional programming. ten patients with patients with severe form of parkinson's disease eligible to deep brain stimulation of the subthalamic nucleus, will be included in two french sites.


Eligibility criteria:
inclusion criteria: 1. age between 18 and 70 years 2. diagnosis of parkinson's disease; as defined by the united kingdom parkinson's disease society brain bank (ukpdsbb) criteria 3. patients eligible for subthalamic bilateral deep brain stimulation (stn-dbs) according to local inclusion criteria; 4. freezing of gait in the off-dopa condition with item 2.13 of the mds-updrs \> 0 in usual life; 5. patient having read and understood the information letter and signed the informed consent form 6. patient affiliated with, or beneficiary of a social security category 7. stability of others medical disorders or that do not interfere with the research protocol. 8. woman of childbearing potential with effective contraception according to who definition (estrogen-progestin or intra-uterine device or tubal ligation) since at least 3 months (negative urinary pregnancy test at inclusion) exclusion criteria: 1. actual and severe psychiatric pathology or other neurological disorder 2. dementia (mms \<24/30) 3. contraindication to research mri (without contrast product) such as claustrophobia, metallic splinters in the eyes, ferromagnetic foreign bodies close to nerve structures, cardiac, orl and neurological devices not mri compatible, wearing of osteosynthseis equipment prior to 1980, metal prostheses, bypass valves ventriculoperitoneal neurosurgery, tattoos containing iron particles... 4. contraindication to surgery: hemostasis trouble, anticoagulants or antiagregants treatment, ongoing infection 5. hypersensitivity to contrasts agents 6. persons under guardianship, tutorship or any other administrative or judicial measure of deprivation of rights and liberty 7. subject at the time of exclusion from other biomedical research or participating in any other biomedical research or therapeutic trial 8. pregnant or parturient or lactating woman or lack of proven and effective contraception according to who definition (estrogen-progestin or intra-uterine device or tubal ligation) (for women of childbearing age)