Kornimate/medical-research-clean huggingface dataset:
non motoric reactions in vojta reflex locomotion

Conditions: Locomotion Disorder, Neurologic

Summary: monitoring of non-motor manifestations of reflex locomotion according to professor vojta in laboratory conditions on healthy woman probands.

the accompanying non-local manifestations during a maximum of 20 minutes of pressure stimulation of the zones defined by the concept of professor vojta will be observed. we will also examine the possible correlation between the magnitude of the response to vojta reflex locomotion (vrl) and the degree of stress and anxiety on the part of the study participants. approximately 20-30 participants will take part in the research. manual stimulation of defined zones will be performed by an experienced physiotherapist who has successfully completed a course in the vojta method. a trigno wireless emg system delsys device will be used to measure electrical muscle activity. kistler force plates and a pliance-x® sensing system pedobarography device will be used to measure changes in standing. the sp-10 pocket spirometer gima and wireless ecg will be used to measure changes in breathing and circulation. in addition, the dass-42 and poms questionnaires will be used. the aim of the study is to clarify whether during manual pressure stimulation of the zones defined by the above concept there is a change in electrical muscle activity, specific activity of the autonomic nervous system and whether there is a different partial pressure distribution in standing after the stimulation. last but not least, the aim of the study is also to determine a possible correlation between the response rate to vrl and the level of stress and anxiety on the part of the study participants. all probands will be familiarized with the experimental measurement procedure and will sign an informed consent form prior to the start of the experiment. measurements will be taken in the kinesiology laboratory of physiotherapy department.

Eligibility criteria:
inclusion criteria: these will be healthy adult women. the expected number of participants is 20-30. to participate in the study, participants must agree to participate voluntarily. exclusion criteria: contraindications for participation include psychiatric illness, cancer, acute inflammatory diseases, and pregnancy. persons with signs of acute illness or injury or in recovery from acute illness or injury will not be eligible for testing.

Keywords: reflex locomotion according to vojta, stress
phase ii study of rr110 in patients with active crohn's disease

Conditions: Crohn's Disease

Summary: the purpose of this study is to evaluate the safety, efficacy and pharmacokinetics profile of 1 and 4 mg/kg/day rr110 administrated orally for 8 weeks in patients with active crohn's disease.


Eligibility criteria:
inclusion criteria: * patients with cdai score ranging from 220 to 450 * patients with crp \> 1 mg/dl * patients who can be hospitalized at least 2 weeks after first administration exclusion criteria: * patients who have previously used anti-tnf antibody, cyclosporine, methotrexate or tacrolimus within 12 weeks of screening * patients who have had surgical bowel resections within 4 weeks of screening * patients who have previously used total parental nutrition or more than 900 kcal/day of enteral nutrition within 4 weeks of screening
clostridium difficile vaccine efficacy trial

Conditions: Clostridium Difficile Infection

Summary: the clover trial is evaluating an investigational vaccine that may help to prevent clostridium difficile infection. participants in the study are adults 50 years of age and older, who are at risk of developing clostridium difficile infection. the study will assess whether the vaccine prevents the disease, and whether it is safe and well tolerated. each subject will receive 3 doses of clostridium difficile vaccine or placebo and be followed for up to 3 years after vaccination for potential clostridium difficile infection.


Eligibility criteria:
inclusion criteria: * evidence of a personally signed and dated informed consent document. * willing and able to comply with study procedures. * subjects with an increased risk of future contact with healthcare systems or subjects who have received systemic antibiotics in the previous 12 weeks. * ability to be contacted by telephone during study participation. * negative urine pregnancy test for female subjects of childbearing potential. exclusion criteria: * investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or subjects who are pfizer employees, including their family members, directly involved in the conduct of the study. * participation in other studies involving investigational drug(s)/vaccine(s) within 28 days prior to study entry until 1 month after the third vaccination. * previous administration of an investigational c difficile vaccine or c difficile mab therapy. * prior episode of cdi.. * receipt of blood products or immunoglobulins within 6 months before enrollment. * subjects who may be unable to respond to vaccination due to: * metastatic malignancy; or * end-stage renal disease; or * any serious medical disorder likely to be fatal within the next 12 months; or * congenital or acquired immunodeficiency; or * receipt of high dose systemic corticosteroids for 14 days within 28 days of enrollment; or * receipt of chronic systemic treatment with other known immunosuppressant medications, or radiotherapy, within 6 months of enrollment. * known infection with human immunodeficiency virus (hiv). * any bleeding disorder or anticoagulant therapy that would contraindicate intramuscular injection. * any contraindication to vaccination or vaccine components, including previous anaphylactic reaction to any vaccine or vaccine-related components. * prior small- or large-bowel resection. * any condition or treatment resulting in frequent diarrhea. * other acute or chronic condition or abnormality that may increase the risk associated with study participation or ip administration or may interfere with interpretation of study results * pregnant or breastfeeding female subjects; male subjects and female subjects who are sexually active and at risk for pregnancy and will not/cannot use 2 methods of contraception
continue entecavir rollover from china

Conditions: Chronic Hepatitis B Virus

Summary: the purpose of the study is to determine if treatment with entecavir is safe and well tolerated in patients who completed dosing in a previous entecavir study in china, but are requiring further treatment of their chronic hepatitis b virus infection.


Eligibility criteria:
inclusion criteria: * subjects who had completed the required dosing period in a previous etv phase 2 or 3 study in china (studies ai463012, ai463023, ai463056), and had been assessed by the investigators as likely to benefit from additional therapy for treatment of their hbv infection * alt ≤ 15 x upper limit of normal * compensated liver disease exclusion criteria: * coinfection with hiv, hcv, or hdv
oxycodone (10, 20 mg) in a postoperative dressing

Conditions: Burns

Summary: the study mainly focuses on pain management using 10- or 20mg oxycodone burn wound dressing at poznan university of medical sciences.

subjects were randomly assigned to one of the two treatment groups, a and b. patients scheduled for burn surgery will sign written consent pre-operatively about procedural pain management. group a received 10mg of oxycodone in wound dressing, while those in group b received 20mg of oxycodone in wound dressing.

Eligibility criteria:
inclusion criteria: * adults scheduled for surgical burn treatment * aged \> 18 years * asa physical status 1,2 or 3 exclusion criteria: * opioid abuse * asa physical status 4, 5
tips with 8- or 10-mm covered stent for preventing variceal rebleeding

Conditions: Decompensated Cirrhosis; Portal Hypertension; Bleeding Varices

Summary: the purpose of this study is to determine whether transjugular intrahepatic portosystemic shunt (tips) with 10-mm covered stent is associated with lower shunt dysfunction in comparing tips with 8-mm covered stent in cirrhotic patients with at least one episode of variceal bleeding.


Eligibility criteria:
inclusion criteria: * cirrhotic patients with at least one episode of variceal bleeding * no active bleeding within 5 days before tips * child-pugh score ≤13 * signed written informed consent exclusion criteria: * an age \ 75 years * with tips contraindications * past or present history of hepatic encephalopathy * pregnancy or breast-feeding * hepatic carcinoma and/or other malignancy diseases * sepsis * spontaneous bacterial peritonitis * uncontrollable hypertension * serious cardiac or pulmonary dysfunction * renal failure * portal vein thrombosis * history of organ transplantation * history of hiv (human immunodeficiency viruses) infection

Keywords: transjugular intrahepatic portosystemic shunt tips liver cirrhosis variceal bleeding 8- or 10-mm covered stent
a compassionate case study to assess the hypotensive efficacy of rho-kinase inhibitor ar-12286 ophthalmic solution 0.5% and 0.7% in glaucoma patients with uncontrolled intraocular pressure to avoid surgical intervention

Conditions: Glaucoma

Summary: a. to evaluate the ocular hypotensive efficacy of the rho-kinase inhibitor (ar-12286 0.5% and 0.7%) ophthalmic solutions in open-angle glaucoma patients with uncontrolled iop who are facing surgical intervention. patients will be treated for 6 months in this initial trial. b. to evaluate the efficacy of ar-12286 in enabling treated patients to delay or avoid the necessity of surgical intervention.


Eligibility criteria:
inclusion criteria: 1. patients with open-angle glaucoma. 2. iop above the target range or visual field progression with use of maximum standard drug therapy. 3. have given written informed consent, prior to any investigational procedures. 4. ability to attend for the 6-month duration of treatment. exclusion criteria: 1. angle-closure glaucoma 2. eyes having had previous incisional glaucoma surgery 3. known hypersensitivity to any component of the formulation (benzalkonium chloride, etc.), or to topical anesthetics. 4. ocular medication of any kind within 30 days of base-line visit, with the exception of ocular hypotensive medications and/or lubricating drops for dry eye (which may be used throughout the study). 5. any abnormality preventing reliable applanation tonometry of the treated eye. 6. clinically significant systemic disease (e.g., uncontrolled diabetes, myasthenia gravis, hepatic, renal, endocrine or cardiovascular disorders) which might interfere with the study. 7. participation in any investigational study within the past 30 days. 8. inability to perform reliable visual field testing. 9. unwilling to sign the consent form approved by the institutional review board (irb) of the new york eye and ear infirmary. 10. self-reported poor compliance to treatment. 11. reluctance to return for scheduled follow-up visits. 12. patients not able to understand the nature of the study.
odm-207 in patients with advance solid tumours

Conditions: Solid Tumors

Summary: this is a first-in-man study to assess the safety and tolerability and to characterise the pharmacokinetics of odm-207.


Eligibility criteria:
inclusion criteria: * patients with histologically or cytologically confirmed locally advanced or metastatic cancer for which no effective standard therapy exists or are refractory or resistant to conventional therapy * life expectancy \>12 weeks * patient may have either measurable or non-measurable disease, but must have disease that can be evaluated for improvement of progression * ecog performance status of 0 to 1 exclusion criteria: * history of bleeding disorder or significant bleeding episode within 6 months prior to study treatment * subjects receiving anticoagulants or medications that durably inhibit platelet function (7-day wash-out prior to study treatment) * history of or current leptomeningeal or brain metastasis or spinal cord compression.
personal web page in clinical trial participant education

Conditions: Prostate Cancer; Kidney Cancer; Genitourinary Cancer

Summary: this research study is evaluating the effectiveness of video and web-based communication in clinical research compared to standard practices.

research has shown that many clinical trial participants are confused about clinical trials. common participant misunderstandings include the idea of randomization, benefits to participants' health, the proven nature of the study intervention, and failure to recognize the primary purpose of the trial. there can sometimes be unintended miscommunication between the study doctor and/or nursing staff and participants. thus, there is a clear need to identify ways to improve communication during clinical trials. the investigator's current culture of web-based information presentation, whether it takes the form of powerpoint presentations, videos, websites, or audio tools, suggests that adding such technology to the cancer research realm may improve a participant's clinical trial experience and possibly improve participant understanding and safety while enrolled on a clinical trial. video and web-based tools in cancer research have the potential to transform clinical trial practice.

Eligibility criteria:
* participants must be ≥ 18 years of age * participants must have an advanced or metastatic genitourinary malignancy (prostate or kidney cancer) * participants must be consented to one of the selected clinical trials (see appendix a) * participants must be able to read and write english * participants must have access to the internet at a minimum of once per week * participants must use the internet at a minimum of once per week * participants must feel at least somewhat confident in how to use the internet, as determined by the eligibility questionnaire to be completed by the participant

Keywords: web based tools video communication web-based communication
correlation between laboratory markers and origin of new brain ischemic lesions after carotid stenting

Conditions: Carotid Stenosis; Brain Ischemia; Laboratory Problem

Summary: new brain ischemic lesions are detected in about 50% of patients undergoing carotid artery stenting (cas). the aim was to assess correlation between selected laboratory markers and occurrence of new brain infarctions after cas.

methods: all consecutive patients 1) with internal carotid artery stenosis \>70%, 2) indicated to cas, 3) with signed informed consent were enrolled to the prospective study during 16 months. all patients used dual antiplatelet therapy (acetylsalicylic acid \[asa\] 100 mg + clopidogrel 75 mg per day) at least 7 days before cas. neurological examination and brain magnetic resonance imaging (mri) were performed before and 24 hours after cas in all patients. venous blood samples were collected within 24 hours before cas in all patients: hematology + reticulocytes, coagulation markers (pt, aptt, inr, fbg, clauss), vwf antigen, pai-1 activity, pai-1 polymorphism 4g/g, multiplate (asa and clopidogrel resistance test). blood samples for the assessment of anti xa activity were collected during cas. t-test was used for statistical evaluation.

Eligibility criteria:
inclusion criteria: patients 1. with internal carotid artery stenosis \>70% 2. indicated to cas 3. with signed informed consent. able to use (acetylsalicylic acid \[asa\] 100 mg + clopidogrel 75 mg per day) at least 7 days before cas exclusion criteria: * contraindication for magnetic resonance imaging

Keywords: ischemic stroke carotid stenting mri diffusion weighted imaging laboratory marker
clinical use and safety of the xtreme touch (magic touch pta)- neo sirolimus coated pta balloon catheter in the treatment of infrainguinal peripheral arterial disease

Conditions: Peripheral Artery Disease; Atherosclerosis

Summary: this study postulates that the application of sirolimus, an anti-proliferative agent that inhibits neointimal hyperplasia, via sirolimus coated balloon (scb) will be safe and will result in better arterial patency in infrainguinal peripheral arterial disease (pad). the aim is to evaluate the efficacy (12 month freedom from clinically driven target lesion revascularisation) and safety (freedom from major adverse events) of sirolimus coated balloons in the treatment of infrainguinal pad.

it is imperative to have effective treatment strategies for pad which can maintain the patency of arteries. the current standard of care for pad is angioplasty which includes usage of drug coated balloons (dcb). paclitaxel is the only anti-proliferative drug available in all currently available dcb technology. sirolimus is another highly effective anti-proliferative drug of immense potential as demonstrated by superior results in sirolimus drug eluting stents in coronary disease. the physical properties of sirolimus have made it challenging for it to be similarly applied to dcb technology and it is only due to recent advances in nanotechnology that it is now possible to develop sirolimus coated balloons (scb), which is the study device used in this study. the study device allows delivery and deposition of sirolimus to the arterial wall. by applying this agent into lesions in peripheral arterial disease, this study aim to effectively reduce neointimal hyperplasia, and therefore prolong the patency of the artery and improve our limb salvage rates for pad and cli patients. subjects will be followed up in the clinic at 6 month, 12 month, and 24 month post-intervention to assess primary and secondary outcome of safety and efficacy.

Eligibility criteria:
inclusion criteria: * age ≥ 21 years or minimum age * subject must be willing to sign a patient data release form or patient informed consent where applicable * lesion(s) in the infrainguinal arteries between 3 to 6mm which are suitable for endovascular treatment treated with the xtreme touch - neo sirolimus pta balloon catheter. for below the knee (btk) arteries, lesions located in the proximal 200mm of the artery. exclusion criteria: * life expectancy ≤ 1 year * subject is currently participating in another investigational drug or device study that has not reached ist primary endpoint yet * subject is pregnant or planning to become pregnant during the course of the study * failure to achieve less than 30% residual stenosis in pre-existing lesion after plain balloon angioplasty * failure to successfully cross the target lesion with a guide wire (successful crossing means tip of the guide wire distal to the target lesion in the absence of flow limiting dissections or perforations

Keywords: pad btk sfa dcb scb
comparative effects of using black seed and cumin seed on bcp of obese grade i

Conditions: Obese

Summary: the goal of this randomized clinical trial is to compare effectiveness of of using black seed (nigella sativa) and cumin seed (cuminum cyminum) on body composition profile of obese grade 1. the primary objective of this study is to compare effectiveness of of using black seed (nigella sativa) and cumin seed (cuminum cyminum) on body composition profile of obese grade 1. subjects will be given a consent form and after subjects read and sign the informed consent, they would be included in study according to eligibility criteria.

obesity is a global pandemic that is associated with high morbidity and mortality. natural herbs are commonly used for weight reduction and appetite suppression. worldwide data based on 1698 studies has shown that the global prevalence of obesity has increased from 3.2 to 10.8% in men and from 6.4 to 14.9% in women. meanwhile, herbal products are marketed for their weight-loss properties, such as nigella sativa which has been used for centuries to treat rheumatoid arthritis, diabetes, and asthma; recently, the anti-obesity characteristics of n. sativa have also been indicated. the antihyperglycemic activity, inhibition of free radical formation, anti-obesity and anti-inflammatory activity of cumin seed extract have also been reported previously.

Eligibility criteria:
inclusion criteria: * subject having bmi between 30 kg/m2 - 34.5 kg/m2 exclusion criteria: * subjects having kidney or liver problems * having ulcers in git * subjects having hypertension, thyroid, diabetes or cardiovascular disorders * pregnant and lactating mothers * subjects who are using hormonal or anti-obesity medications

Keywords: cumin seeds black seed obese grade i
decreasing unnecessary antibiotics prescribed for possible pneumonia despite normal respiratory rate and oxygenation

Conditions: Pneumonia

Summary: the purpose of this study is to decrease unnecessary antibiotics prescribed to hospitalized patients for possible pneumonia by flagging patients with respiratory rates and oxygenation levels within reference ranges given prior data suggesting that discontinuing antibiotics in this population is safe. patients will be randomized to 3 arms: 1) usual care, 2) electronic alert, or 3) pharmacist outreach.

prior data suggest antibiotic starts for patients with normal vital signs are common and there does not appear to be harm associated with stopping antibiotics after only 1 or 2 days in patients with normal oxygen saturations. we therefore propose a pilot patient-level three-way randomized trial to determine the best way to operationalize professional society recommendations for post-prescription antibiotic reviews amongst patients started on antibiotics with a stated indication of pneumonia despite normal respiratory rates and oxygenation levels. if the patient's median respiratory rate and oxygen saturation is normal after 1-2 days of antibiotics they will be randomized to usual care versus a ehr-based best practice alert versus pharmacist outreach. the ehr-based best practice alert will highlight the patient's normal respiratory rate and oxygenation and encourage stopping antibiotics if there isn't another indication for antibiotics. pharmacist outreach will involve contacting the responding clinician or attending physician to determine the working diagnosis, review the patient's vital signs, and to ask the team to consider stopping antibiotics if there are no clear indications for antibiotics. in all cases, the final decision on whether to stop or continue antibiotics will be up to the primary team. we will assess the impact of these post-prescription review strategies to decrease unnecessary antibiotic utilization on antibiotic utilization (antibiotic days and antibiotic-free days) compared to usual care. safety outcomes will include time to discharge, readmissions, hospital-free days, and mortality. we will also assess for change in the primary outcome over time.

Eligibility criteria:
inclusion criteria: * all patients admitted to brigham and women's and bwh faulkner hospitals and prescribed antibiotics with a stated indication of pneumonia who have a median respiratory rate of ≤20 and oxygen saturation of ≥95% without supplemental oxygen sustained for at least 24 hours. exclusion criteria: * patients under 18 years old, patients on transplant and oncology services, patients who are pregnant, patients in an intensive care unit, patients with cystic fibrosis or bronchiectasis, patients on immunosuppressive medications, and patients with positive blood cultures (other than common skin contaminants)

Keywords: antibiotic stewardship pneumonia