Kornimate/medical-research-clean huggingface dataset:
tai ji quan and cognitive function in older adults with mild cognitive impairment

Conditions: Mild Cognitive Impairment

Summary: to determine the efficacy of a cognitively enhanced exercise intervention - tai ji quan: moving to maintain brain health in improving global cognitive function and dual-task ability in older adults with mild cognitive impairment.

the primary aim of the study is to determine the efficacy of a cognitively enhanced exercise intervention - tai ji quan: moving to maintain brain health, relative to a standard tai ji quan intervention and an exercise stretching control, in improving global cognitive function and dual-task ability among community-dwelling older adults with amnestic mild cognitive impairment.

Eligibility criteria:
inclusion criteria: * complaint of memory loss * clinical dementia rating (cdr) scale score ≤0.5 * having normal general cognitive function screened, with mmse ≥24 * capable of exercising safely, as determined by a healthcare provider * willingness to be randomly assigned to an intervention condition and complete the 24-week intervention and 6-month follow-up exclusion criteria: * having medical conditions likely to compromise survival, such as metastatic cancer, or render a participant unable to engage in physical activity, such as severe cardiac failure * participating in any type of tai ji quan or daily and/or structured vigorous physical activity (i.e., brisk walking for exercise 30 minutes or longer at a time, or engaging in muscle-strengthening activities, e.g., weight lifting on 3 or more days per week 3 months prior to the study)

Keywords: cognitive function mild cognitive impairment tai ji quan
outcome of carbon dioxide versus air insufflations during endoscopic retrograde cholangiopancreatography (ercp)

Conditions: Obstructive Jaundice

Summary: to assess the safety and efficacy of co2 insufflations during ercp 1. primary objective: to assess the patient's symptoms, abdominal pain and abdominal distension post procedure (ercp) in the study group. 2. secondary objective: endoscopist: * to assess the adequacy of bowel distension for adequate luminal visualization * to assess the peristaltic movement during the ercp anesthetist: * to measure the pco2 level in patient post procedure. * to assess the amount of sedation required during the procedure. * to assess saturation and vital signs through out the procedure. * to assess requirement of buscopan.

mentioned in complete

Eligibility criteria:
inclusion criteria: * all consecutive adult patients referred for ercp to aig hyderabad exclusion criteria: * age \< 18 years old excluded from the study. * patients with copd. * patients with poor ejection fractions and decompensated heart failure. * patients with acute illness that require emergency ercp and not fit for pre procedure and post procedure assessments. * patients with recent endoscopic procedure within 24 hours. * patient with history of recent surgery within 7 days of duration. * pregnant patients. * patients not keen to give consent for the study.

Keywords: carbon dioxide insufflation
therapeutic substance abuse treatment in pregnancy - 1

Conditions: Alcohol Abuse; Cocaine Abuse; Marijuana Abuse

Summary: the purpose of this study is... to assess whether a behavioral treatment that combines motivational enhancement and cognitive skills training therapy (met-cbt) is more effective than brief advice in: 1) decreasing use of a full range of psychoactive substances (e.g. marijuana, cocaine, methamphetamines, alcohol, nicotine, opioids) in pregnant substance using and dependent women; 2) decreasing hiv risk behavior; 3) improving birth outcomes (longer gestations and greater birth weight).

we propose an integrated system of counseling services onsite in primary care obstetrical clinics, comparing a manualized brief advice (closely approximating "treatment as usual") to manualized motivationally enhanced cognitive behavioral therapy. treatment providers are obstetrical nurses. therapy patients are taught skill sets designed to enhance motivation to abstain from drugs of abuse, as well as designed to prevent relapse during the perinatal period. it is our hypothesis that therapy patients will be more successful at achieving stated study aims than those receiving brief advice.

Eligibility criteria:
inclusion criteria: pregnant women, age 16 or older, alcohol or illicit drug use in the past 30 days - exclusion criteria: nonfluent in english or spanish, pending incarceration, psychotic, cognitively unable to give informed consent, actively suicidal or homicidal, already engaged in addictions treatment, primarily addicted to nicotine or heroin. -
relationship between health literacy and physical activity in adult patients with cystic fibrosis

Conditions: Cystic Fibrosis

Summary: the purpose of this study investigation of relationship between health literacy and physical activity, anxiety and depression, adherence to airway clearance techniques in adult patients with cystic fibrosis.

the assessment will begin with demographic information then health literacy, depression and anxiety and physical activity level will evaluation with related questionnaires.

Eligibility criteria:
inclusion criteria: be between the ages of 18-65 volunteering to participate exclusion criteria: having any cardiopulmonary disease having cognitive problems being illiterate
stem cell transplant for high risk central nervous system (cns) tumors

Conditions: Glioblastoma; Astrocytoma; Pineoblastoma; Rhabdoid Tumor; Supratentorial Neoplasms

Summary: the primary goal of this study is to determine if a stem cell transplant in patients with newly diagnosed high risk cns tumors (glioblastoma multiforme \[gbm\], high grade astrocytoma, pineoblastoma, rhabdoid tumor, supratentorial primitive neuroectodermal tumor \[pnet\]) increases overall survival.


Eligibility criteria:
inclusion criteria: * patient's age must be greater than (\>) 18 months and less than or equal to (≤) 25 years at the time of diagnosis or recurrence. * neuroradiographic evidence of a recurrent posterior fossa medulloblastoma or recurrent cns germ cell tumor. * the presence of a histologically confirmed high grade astrocytoma, gbm, rhabdoid tumor, supratentorial pnet, or pineoblastoma either at the time of diagnosis or recurrence. * patients must be brought to state of minimum residual disease by surgical reduction and/or chemotherapy and/or radiation therapy or a combination of above prior to myeloablative chemotherapy and tandem stem cell rescue. * documentation of chemotherapy sensitivity is required for enrollment. chemotherapy-sensitive tumors are defined as those tumors which have had a reduction of 50% after 2-4 cycles of chemotherapy (ctx or platinum). for patients with no evidence of disease post resection, continued complete remission after 2-4 cycles of chemotherapy defines chemosensitivity. * adequate physiologic function, defined as follows: * creatinine clearance \> 70 ml/minutes/1.73 m2. * sgpt \< 10 x normal and bilirubin \< 10 mg/dl. * adequate complete blood count (cbc): hemoglobin \> 10 gm/dl, absolute neutrophil count (anc) \> 1500/ul, and platelets \> 100,000/ul. * informed consent. the patient and/or the patient's legally authorized guardian must acknowledge in writing that consent to become a study subject has been obtained, in accordance with institutional policies provided by the united states (u.s.) department of health and human services. * protocol approval. approval for the use of this institution's human rights committee must be obtained in accordance with the institutional assurance policies of the u. s. department of health and human services. * patients with high-risk medulloblastoma after initial surgery. * to allow non-english speaking patients to participate in this study, bilingual health care services will be provided in the appropriate language. exclusion criteria: * patients with brain stem glioma are ineligible.

Keywords: brain tumor medulloblastoma germ cell tumor cns tumor glioblastoma astrocytoma pineoblastoma rhabdoid tumor supratentorial pnet high grade astrocytoma
aldosterone blockade in chronic kidney disease: influence on arterial stiffness and kidney function

Conditions: Chronic Kidney Disease

Summary: patients with chronic kidney disease (ckd) have a poor prognosis primarily due to cardiovascular disease. the cardiovascular risk can be assessed by measurements of arterial stiffness. a decrease in stiffness has been shown to decrease the risk of cardiovascular disease as well as death. most of the ckd population also have hypertension and the control of blood pressure is one of the corner stones in inhibition of disease progression. using drugs that specifically block the renin-angiotensin-system for blood pressure control has been shown to have a beneficial impact on inhibition of progression beyond that of the achieved blood pressure control. it has been reported that inhibition of the hormone aldosterone has a positive effect on survival in patients with heart failure, hypertension and diabetic as well as on-diabetic nephropathy. this study undertakes the investigation of the influence on arterial stiffness of adding an aldosterone receptor inhibitor to the medication ckd patients are already taking. besides the primary end point which is pulse wave velocity (pwv), arterial stiffness is also quantified thorough ambulatory blood pressure measurements.


Eligibility criteria:
inclusion criteria: * ≥ 18 years age ≤ 80 years age * voluntarily signed informed consent * 15 ml/min/1,73 m2 ≤ estimated glomerular filtration rate \< 60 ml/min/1,73 m2 * bp ≥ 130/80 mmhg or undergoing anti-hypertensive treatment exclusion criteria: * p-potassium is \> 5.0 mm * allergy to contents * treated with spironolactone * treated with potent inhibitors of cyp3a4 (see spc for details) * treated with lithium, ciclosporin, tacrolimus, prednisolone, or other immunosuppressing drug * inborn errors of metabolism (see spc for details) * pregnancy or lactation * fertile woman, not using safe contraception devices * dementia or other psychiatric disorder, making understanding of the study conditions impossible * other severe, chronic illness besides ckd, including liver insufficiency, according to investigators' judgement * vascular surgery including stenting or graft implantation on a. brachialis, aorta or the carotid arteries * systolic bp \> 200 mmhg * immeasurable pulse amplitude

Keywords: aldosterone receptor inhibition arterial stiffness ambulatory arterial stiffness index
the biological activity of cediranib (azd2171) in gastro-intestinal stromal tumours(gist).

Conditions: Gastrointestinal Stromal Tumors; Soft Tissue Sarcomas

Summary: to determine the anti-tumour activity and biological effects of cediranib (azd2171) at a dose of 45mg, primarily in gastrointestinal stromal tumour (gist) patients who are resistant to imatinib mesylate (current standard therapy) and also in patients with metastatic soft tissue sarcoma (sts) resistant to standard therapy.


Eligibility criteria:
inclusion criteria: * histological or cytological confirmation of gist which is resistant or intolerant to imatinib mesylate, or metastatic sts, which is refractory to standard therapies or for which no standard therapy exists exclusion criteria: * patients with type i insulin-dependent diabetes or poorly-controlled type ii insulin-independent diabetes. * patients with a history of poorly controlled high blood pressure

Keywords: cancer tumour advanced cancer metastatic gastro-intestinal stromal tumours gastro-intestinal cancer recentin
phase 1 study of ulsc in patients with polymyositis (pm) and dermatomyositis (dm)

Conditions: Polymyositis; Dermatomyositis

Summary: this study will investigate umbilical cord lining stem cells (ulsc) as an investigational medicinal product and its use in patients with polymyositis (pm) or dermatomyositis (dm) to see if a single intravenous (iv) infusion of allogeneic umbilical cord lining stem cells (ulsc) safe, tolerable, and feasible to administer.


Eligibility criteria:
inclusion criteria: 1. adult, male or female, age ≥18 years old 2. diagnosis of definite or probable dm or pm, according to the criteria of bohan and peter 3. patients with pm will either be positive for a myositis-associated antibody or have undergone evaluation to exclude mimics, as deemed appropriate by the investigator (see note below). 4. signs informed consent. exclusion criteria: 1. a diagnosis of inclusion body myositis, juvenile dm or pm, myositis in the context of significant overlap with another systemic autoimmune rheumatologic disease. 2. non immune myopathies. 3. cancer associated myositis. 4. hypersensitivity to study product components. history of hypersensitivity to dimethyl sulfoxide (dmso). 5. pregnant or lactating women. 6. concomitant severe cardiac, pulmonary disease, active infection or other conditions that preclude assessment of safety and efficacy of the study product. 7. patients with predominant muscle atrophy secondary to uncontrolled or chronic dm or pm, based on clinical, biochemical, and/or radiologic assessment, despite previous optimized treatment. 8. anticipated need for surgery during the trial period. 9. a history of prevalent noncompliance with medical therapy. 10. recipient of an organ transplant. 11. neutropenia (absolute neutrophil count\<1,800/mm3 \[or \<1,000/mm3 in african-american subjects\]). 12. severe impairment in renal function (estimated glomerular filtration rate \<30 ml/kg\*min). 13. recent or planned use of vaccination with live attenuated viruses. 14. active cancer or prior diagnosis of cancer within the past 2 years (patients with basal and squamous cell cancer of skin will not be excluded). 15. condition that would impair an assessment of muscle strength, including neurological disorders such as parkinson's disease or severe musculoskeletal condition. 16. any other condition that, in the judgment of the investigator or sponsor, would be a contraindication to enrollment, study product administration, or follow-up. 17. history of atrial septal defect or ventricular septal defect
comparison of two daily disposable soft contact lenses

Conditions: Astigmatism Bilateral

Summary: the aim of this study was to investigate the short-term clinical performance and subjective acceptance of the two study lenses.

this study was a randomised, double-masked, crossover, bilateral dispensing study, controlled by cross-comparison. fifty-five subjects will wear each lens brand for approximately one week in random order. lenses were worn on a daily wear, daily disposable basis.

Eligibility criteria:
inclusion criteria: 1. they are between 18 and 40 years of age (inclusive). 2. they understand their rights as a research subject and are willing to sign a statement of informed consent. 3. they are willing and able to follow the protocol. 4. they are an existing silicone hydrogel reusable spherical contact lens wearer in both eyes. 5. they have a contact lens spherical prescription between -0.25d and -6.00d (inclusive) based on ocular refraction. 6. they own a wearable pair of spectacles and wear them on the day of the initial visit. 7. at dispensing, they can attain at least 0.20 logmar distance high contrast visual acuity in each eye with the study lenses within the available power range. 8. they are willing to comply with the wear schedule (at least five days per week and for at least eight hours per day). 9. they agree not to participate in other clinical research for the duration of the study. exclusion criteria: 1. they have an ocular disorder, which would normally contra-indicate contact lens wear. 2. they have a systemic disorder, which would normally contra-indicate contact lens wear. 3. they are using any topical medication such as eye drops or ointment, or use any rewetting/lubricating drops whilst on this study. 4. they are aphakic. 5. they have had corneal refractive surgery. 6. they have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus. 7. they are pregnant or breastfeeding. 8. they have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear 9. they have any infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or they have any immunosuppressive disease (e.g. hiv), or a history of anaphylaxis or severe allergic reaction. 10. they have taken part in any contact lens or care system clinical research within two weeks prior to starting this study.
a dose-ranging study to evaluate the safety and efficacy of unr844 in subjects with presbyopia.

Conditions: Presbyopia

Summary: study of safety and efficacy of unr844 in subjects with presbyopia.

this was a randomized, placebo-controlled, double-masked,multi-arm, parallel-group, multi-center 13-month study which consisted of: * a 1 week run-in period * a 3-month treatment course with unr844 and/or placebo * a 9-month treatment holiday period participants were randomized equally to one of five treatment arms: unr844 5 mg/ml,unr844 13.3 mg/ml, unr844 23 mg/ml, unr844 30 mg/ml, or placebo eye drops twice-a-day for three months. participants underwent a 1 week run-in period where they were assessed for entry criteria during the screening visit. during the run-in period, participants self-administered 1 drop of artificial tears twice-a-day (1 drop in the morning and 1 drop in the evening) in each eye at home. this run-in period was designed to help minimize any potential variability in distance corrected near visual acuity (dcnva) caused due to initial ocular surface issues and help to establish an accurate baseline prior to randomization. the run-in period was to help exclude participants with a change in dcnva of 0.10 logmar difference between screening and baseline. this study was conducted to determine the optimum dose of unr844 treatment and the duration of effect of unr844 treatment for further development.

Eligibility criteria:
inclusion criteria: * written informed consent must be obtained before any assessment is performed * impaired near vision in each eye and when using both eyes, without any near correction * need a certain level of near correction exclusion criteria: * impaired distance vision in either eye, with distance correction (if any) * severe short- or long-sightedness * any significant medical or clinical conditions affecting vision, the eyes or general health

Keywords: loss of elasticity in lens lens lens disorder loss of near vision presbyopia unr844 farsightedness
neurophysiological correlates of cognitive tasks in healthy volunteers -wp3 p003

Conditions: Alzheimer Disease; ELECTROENCEPHALOGRAPHIC VARIANT PATTERN 1 (Disorder)

Summary: in the perspective to better evaluate the efficacy of new treatment strategies for alzheimer disease (ad), it appears important to develop experimental paradigms to precisely measure cognitive endpoints/biomarkers that may be used in healthy volunteers as tools to validate drug efficacy profile. the use of electroencephalography (eeg) may be, therefore, a good candidate. the purpose of the present study is to use eeg to more precisely explore cognitive processes in healthy subjects, with a particular interest in episodic and working memory functions that are usually altered in both ad and mild cognitive impairment (mci) as well as to better understand underlying neural mechanisms involved in these processes.


Eligibility criteria:
inclusion criteria: * right-handed * in good health on the basis of the medical interview (medical history, symptoms), the physical examination and vital signs * non smoker and with no history of drug or alcohol abuse * without chronic treatment * with normal hearing and normal vision including color (with correction) * french speaker and able to understand the test instructions * has provided written informed consent * able to read and understand the information form and comply with the protocol instructions and restrictions exclusion criteria: * cognitive impairment (moca \< 26) * cognitive complaint (macnair scale \> 15) * history of brain disease (severe brain trauma, stroke, cerebral tumor...) or current cerebral disease * major medical or surgical history * current chronic disease * vascular or metabolic risk factor * history or current mental disease or addiction (mini) * family history of young onset dementia * family history of chronic or severe neurological or mental disease (first degree relatives) * in the opinion of the investigator, is unlikely to comply with the study protocol or is unsuitable for any other reason * participates to another clinical trial or is still being within a washout period of a previous clinical trial * already exposed to cognitive tests used in this study.

Keywords: cognitive tasks mild cognitive impairment neurophysiological correlates healthy volunteers
an open-label, bioequivalence study to evaluate lev administered as a 45-min intravenous infusion and same dosage lev oral tablet in chinese

Conditions: Human Volunteers

Summary: the part a of n01362 is to evaluate the bioequivalence of levetiracetam (lev) 1500 mg intravenous (iv) infusion when compared to tablet oral administration in chinese healthy volunteers.

the study includes 2 parts, part a is to evaluate the bioequivalence of levetiracetam (lev) 1500 mg intravenous (iv) infusion when compared to oral tablet, part b is to assess pharmacokinetic profile of lev infusion during repeated dosing in chinese healthy volunteers.

Eligibility criteria:
inclusion criteria: * chinese, age 18-40, weight ≥ 50 kg * healthy volunteers with normal vital signs, good physical and mental health status and normal electrocardiogram and laboratory test exclusion criteria: * history or presence of each systems disorders capable of altering the absorption, metabolism or elimination of drugs, or of constituting a risk factor when taking the study medication * history or presence of drug addiction or excessive use of alcohol * symptomatic or asymptomatic orthostatic hypotension at screening * current smokers and former smokers * heavy caffeine drinker * history of frequent and severe headache * any drug treatment * subjects who are known to have serum hepatitis or who are carriers of the hepatitis b surface antigen, or hepatitis c antibody or who are hiv positive * subjects on a controlled sodium diet * subject has made a blood donation or had a comparable blood loss

Keywords: keppra levetiracetam intravenous oral tablets bioequivalence pharmacokinetics safety chinese healthy volunteers
transauricular vagus nerve stimulation in the treatment of chemotherapy-induced peripheral neuropathy

Conditions: CIPN; Chemotherapy-induced Peripheral Neuropathy

Summary: chemotherapy induced peripheral neuropathy is common in tumor patients receiving chemotherapy. nowaday, cipn is mainly treated with drugs, but the therapeutic effect is not satisfactory. previous studies have found that inflammatory immune mechanism plays an important role in neuropathic pain. vagus nerve stimulation can not only relieve pain by regulating the autonomic nervous system, but also participate in the immune response. investigators hope that the treatment by vagus nerve electrical stimulation through ear skin can improve the pain and neurotoxicity scores of cipn patient.if it is proved that vagus nerve stimulation can effectively treat cipn, it will become a simple and safe non-drug treatment which has good application prospects.


Eligibility criteria:
inclusion criteria: 1. patient is currently receiving chemotherapy drugs with neurotoxicity 2. new or worsening numbness and / or pain in the hands and / or feet, and no other cause explains the above symptoms exclusion criteria: 1. patients with sinus bradycardia, long qt syndrome, sick sinus syndrome or other arrhythmias, mental diseases, cardiac pacemakers or other electrical stimulation devices after implantation. 2. patients taking analgesics due to pain in other parts of the body.