Kornimate/medical-research-clean huggingface dataset:
effects of ritalin on postural stability of hyper active children

Conditions: Attention Deficit Disorder With Hyperactivity

Summary: experimental design overview the proposed project is a prospective experimental study design. children (age \<15) suffer from attention deficit hyperactivity disorder (adhd) that their parents willing to participate in the study will be tested with well-established measuring techniques of balance control before and 1 hour after taking of methylphenidate (ritalin) in the movement and rehabilitation laboratory at bgu. an automated algorithm will be used to extract standardized stabilogram-diffusion parameters from each of the cop data sets collected during quiet standing. these parameters include diffusion coefficients, critical displacement, critical time and scaling exponents for both lateral and anterior-posterior sway directions (collins \& de luca, 1993). for each of the conditions (before and 1 hour after the use of ritalin) in three task conditions single task; dual task (concentrating and identifying specific music); and just listening to a relaxing music. participants will be required to stand on the platform 10 times for 30 s. for each trial, they will be instructed to sway as little as possible.


Eligibility criteria:
inclusion criteria: * age 6-12 years old * diagnosed as adhd childrens by a neurologist * taking methylphenidate (ritalin) exclusion criteria: * children who suffer from cp, or other neurological disease * children who suffer from psychiatric state * children who suffer from orthopedic condition (1/2 a year after a fracture in the lower limb)

Keywords: attention deficit hyperactivity disorder (adhd) dual tasking postural control methylphenidate (ritalin) the focus of the study is to explore the effects of ritalin on postural control in adhd children, during single and dual task conditions.
continuous measurement of the activity for clinical evaluation at home, for non-ambulant neuromuscular patients

Conditions: Neuromuscular Disease

Summary: validation of a measure specifically suitable to evaluate the residual function of upper limbs of non-ambulant neuromuscular patients, especially with duchenne muscular dystrophy and spinal muscular atrophy. this approach is of fundamental importance for clinical monitoring and preparing the future therapeutic trials.

the main objective is the continuous measurement of muscle activity in a standardized setting and in the non ambulatory patient's natural environment. this measure uses an innovative technology based on accelerometer and magneto-inertial sensors. the system is intended to measure the physical activity of patients from the extraction of data recorded by the sensors in the three space axes. the non ambulatory patients will be included and evaluated at baseline and 14 days later. the patients wear the accelerometer device during some standard evaluations and also at home continuously for 14 days. with this protocol the investigators want to try to find the best variable that characterizes the movement of the upper limbs of non-ambulant neuromuscular patients. the aim of pre-acti is to propose a primary outcome measure that may be used in clinical monitoring of patients.

Eligibility criteria:
inclusion criteria: * age over 10 years * neuromuscular disease documented by genetic testing or by muscle biopsy * not able to walk 10 meters without support * capable of sitting upright in a wheelchair for at least 3 hours * subject affiliated to a social security system * subject who signed an informed consent exclusion criteria: * severe intellectual impairment limiting the comprehension of the demanded tasks * acute neurologic, inflammatory, infectious, endocrine, orthopedic disease in the month preceding the inclusion * surgery scheduled within 3 weeks after enrollment * surgery at upper limbs in the three months preceding the inclusion * pregnant or nursing women

Keywords: accelerometry neuromuscular disease
phase ii metastatic er+/pgr+ nolvadex +/- iressa study

Conditions: Breast Neoplasms

Summary: this study is being carried out to see if zd1839 is effective in treating metastatic breast cancer in combination with nolvadex, and if so, how it compares with nolvadex alone.


Eligibility criteria:
inclusion criteria: * histologically confirmed metastatic adenocarcinoma of the breast (seetnm staging appendix i) that is er and/or pr positive as determined in local laboratories at each investigator site (central verification of er status will be performed after the patient starts treatment * a tissue block from either the metastatic or primary tumor site is required. * who performance status (ps) 0-2 * patients must not be pregnant or breast-feeding. a negative pregnancy test is required within 7 days prior to randomization if pre- or peri-menopausal. postmenopausal patients are defined as: * natural menopause with last menses \> 1 year ago, * radiation induced oophorectomy with last menses \> 1 year ago, * chemotherapy induced menopause with 1 year interval since last menses, or * serum fsh and lh and plasma estradiol levels in the postmenopausal range for the institution. * bilateral oophorectomy exclusion criteria: * patients cannot be on hormone replacement therapy or received prior chemotherapy for metastatic disease. * patients previously treated with a tyrosine kinase inhibitor or have evidence of an active interstitial lung disease are not eligible. * treatment with lh-rh analog. * laboratory values as follow bilirubin \>1.5 times upper limit of normal uln, alanine amino transferase (alt) or aspartate amino transferase (ast) \>2.5 times the uln if no demonstrable liver metastases, or \>5 times the uln in the presence of liver metastases * bone marrow function: wbc \<1500 mm3

Keywords: breast cancer metastatic breast cancer
drip-infusion of remifentanil for rih

Conditions: Hyperalgesia

Summary: the development of remifentanil-induced hyperalgesia (rih) is an unpleasant experience for surgical patients. an alternative management, gradual withdrawal of remifentanil was effective in prevention of rih. the investigators designed a simple modality to assess if under withdrawal of remifentanil and further drip-infusion of remifentanil immediately after extubation affected postoperative pain score, the requirement of rescue analgesics, and adverse effects.

in clinical practice, the gradual withdrawal of remifentanil during surgery is unsatisfied. thus, the investigators conducted a simple modality in a single center retrospective cohort study to assess how under baseline gradual withdrawal of remifentanil and further drip infusion of remifentanil immediately after extubation affected postoperative pain score and use of analgesics.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists (asa) score of i-iii patients receiving total intravenous anesthesia exclusion criteria: * the use of inhalation agents or propofol combined with inhalation anesthesia * pregnancy * previous substance abuse * known allergies to opioids, propofol or any drugs used in the study * history of neuropsychiatric disorder * age \ 80 years

Keywords: remifentanil hyperalgesia drip-infusion
cardiovascular risk assessment for patients with rheumatoid arthritis arthritis:

Conditions: Rheumatoid Arthritis; Cardiovascular Diseases; Hyperlipidemias

Summary: one of the greatest success stories in rheumatology - the achievement of rheumatoid arthritis (ra) remission - is tempered by the fact that individuals with ra are dramatically under evaluated and under treated to reduce the risk for heart attacks and strokes. this project will build the foundation for an intervention that will test the hypothesis that the patient-centered intervention tailored to patients with ra to improve hyperlipidemia screening and treatment, thereby decreasing the risk for heart attacks and strokes. the aims of this proposal are: aim 1: to identify patient and physician barriers to lower the risk for heart attacks and strokes in patients with ra. aim 2: to develop an intervention designed to optimize lipid screening and management in ra patients. this will consist of patient education and a decision support program to facilitate screening for hyperlipidemia (high cholesterol level) or initiation of medications to lower cholesterol (primary outcome) and self-efficacy (level of confidence in performing a task) in taking medications to lower cholesterol secondary outcome). aim 3: to pilot test the efficacy and feasibility of intervention developed in aim 2. the investigators will apply methods related to clinical trials to test the feasibility of the newly developed intervention.


Eligibility criteria:
inclusion criteria: * have ra * age between 40 and 75 years (inclusive) * provide a date of their next appointment with their rheumatologist or other physician on their care team * willing to work with a peer coach * speaks english * have a phone * has access to the internet * resides or lives in the us exclusion criteria: * do not have rheumatoid arthritis * younger than age 40 or older than age 75 * taking a statin * no known history of diabetes * no known history of cvd defined by: * open heart surgery * coronary angioplasty * history of heart failure * history of heart attack or stroke

Keywords: self-efficacy patient activation social cognitive theory peer coaches
evaluation of implants placed immediately or delayed into extraction sites

Conditions: Dental Caries

Summary: irb4729 study hypothesis: is there a significant difference in the hard and soft tissue response comparing immediate with delayed implant after tooth removal, with immediate provisionalization, in maxillary anterior sites. the purpose of this study is to determine and compare the crestal bone levels as the primary endpoint variable for implants placed and temporized in extraction sites, to implants placed into extraction sites after the extraction site has been grafted and healed for 4 months, all immediately restored with an anatomic provisional restoration.


Eligibility criteria:
inclusion criteria: * all patients will be willing to be present for examination two times a year for at least three years, as well as maintenance cleaning twice a year 3 months prior to the data collection visit * all patients will be free of uncontrolled diabetes (any type, existing malignancy, and will not be receiving any therapy that suppresses their immune system, such as radiation, chemotherapy, or chronic steroid usage * need for extraction of a single rooted maxillary central or lateral incisor, canine, or premolar, with no signs of acute infection (purulent exudate, erythema, pain and swelling). * patients will have bone present on all surfaces of the tooth within 3mm of the gingival margin of the planned restoration, in order to provide sufficient bone to circumferentially cover the implant. * all patients will have adequate space for satisfactory restoration of the edentulous space. * each patients dentition will be free of active periodontal disease or exhibit controllable periodontal disease such that their teeth will clinically be non-mobile and have probing depths less than 3mm. * all prospective sites will have at least 2mm of attached or keratinized gingiva. * the crestal bone width should be enough to accommodate either a 3.75mm diameter implant for the central incisor, canine, and premolar sites or a 3.25 mm diameter implant for the lateral incisor tooth sites. bone heights should be at least 14mm for accommodation of the implant. exclusion criteria: * patients with labial dehiscence defects greater than 3mm from the proposed gingival margin of the planned restoration will be excluded from this study. * patients who cannot come for follow up due to conflicts of schedules will not be accepted into the study. * patients with advanced cardiovascular, pulmonary, renal, liver disease that place them in an asa iii or iv rating will be excluded. post-menopausal women with known osteoporosis as determined by their medical internist, will be excluded. patients with known alcohol abuse will be excluded.

Keywords: partial edentulism bone atrophy bone healing
a study of dideoxycytidine in hiv-infected patients

Conditions: HIV Infections

Summary: to determine how much of a dose is absorbed by the body when zalcitabine ( dideoxycytidine; ddc ) is given orally and how long the drug stays in the body after absorption or intravenous (iv) administration. laboratory tests have shown that ddc is effective in stopping the growth of the hiv in test tubes. the study will reveal the pharmacokinetic (blood levels) properties of this new drug and how long the drug remains in the body at each of six doses. this should be useful background information and should allow a simple and efficient comparative study of any new oral formulation, such as a tablet or capsule, since dose-related problems will already be known.

laboratory tests have shown that ddc is effective in stopping the growth of the hiv in test tubes. the study will reveal the pharmacokinetic (blood levels) properties of this new drug and how long the drug remains in the body at each of six doses. this should be useful background information and should allow a simple and efficient comparative study of any new oral formulation, such as a tablet or capsule, since dose-related problems will already be known. patients are hospitalized and receive ddc twice, once by mouth and once by iv injection. each patient receives the drug at one of six increasing doses, and no patient is studied at more than one dose level. following each dose, toxicity is measured before the next higher dose is given. several blood samples and urine specimens are taken to permit measurement of the amount of drug in the bloodstream and of the speed with which it is eliminated from the body.

Eligibility criteria:
inclusion criteria prior medication: allowed: * oral nonabsorbable antifungal agents. exclusion criteria * active drug or alcohol abuse. co-existing condition: * patients with fever \> 102 degrees f at study entry will be excluded. * patients with fever \> 102 degrees f at study entry will be excluded. prior medication: excluded: * chronic systemic medications. * any other experimental drug within 2 weeks of study entry. * drugs with known nephrotoxic or hepatotoxic effects within 2 weeks of study entry. * drugs known to cause neutropenia within 2 weeks of study entry. * rifampin or rifampin derivatives, phenytoin, or barbiturates within 2 weeks of study entry. * any other medication except oral nonabsorbable antifungal agents within 72 hours of study entry. all medications, including aspirin, must be approved by investigator. all medications, including aspirin, must be approved by investigator. patients must demonstrate the following clinical and laboratory findings: * aids, aids related complex (arc), or persistent generalized lymphadenopathy as defined by the cdc classification. * no ascites. * off all medications except oral antifungal, nonabsorbable agents for 72 hours prior to study entry.

Keywords: zalcitabine drug evaluation acquired immunodeficiency syndrome aids-related complex biological availability
transdermal trigeminal electrical neuromodulation on mild cognitive impairment with insomnia

Conditions: Insomnia; Alzheimer Disease; Mild Cognitive Impairment; Amyloid

Summary: this study aims to validate the safety and impact of transdermal trigeminal electrical neuromodulation(cefaly) on mild cognitive impairment patients with insomnia on brain functional and structural connectivity as well as sleep parameters evidenced by polysomnography and sleep surveys, with consideration for amyloid positivity and brain-derived neurotrophic factor .

this study aims to validate the safety and impact of transdermal trigeminal electrical neuromodulation(cefaly) on mild cognitive impairment patients with insomnia on brain functional and structural connectivity as well as sleep parameters evidenced by polysomnography and sleep surveys, with consideration for amyloid positivity and brain-derived neurotrophic factor . a 3-month intervention with transdermal trigeminal electrical neuromodulation will be implemented and sleep surveys, polysomnography and brain mri will be attained both at baseline and post-intervention.

Eligibility criteria:
inclusion criteria: * diagnosed with mild cognitive impairment by modified peterson's criteria * identified as amyloid positive by amyloid pet result * insomnia severity index of more than 15 or diagnosed with insomnia disorder by diagnostic statistical manual-5 exclusion criteria: * subjects with active psychiatric or neurological disorders * unstable medical conditions (myocardial infarction, cerebral infarction, congestive heart failures etc.) * moderate to severe obstructive sleep apnea (apnea hypopnea index of more than 15), rapid eye movement disorder, narcolepsy * on regular hypnotic medication (can enroll if there was 2-week wash out period) * currently receiving or having a past history of cognitive behavioral therapy for insomnia * patients who received transcranial magnetic stimulation (tms), transcranial direct current stimulation, within 2 weeks before enrollment * who are on cognitive enhancers (choline alfoscerate, acetylcarnitine, acetylcholinesterase inhibitors, nmda receptor antagonist) * history of cerebral infarction or parkinson's disease * history of facial or brain trauma * a subject with allergy to acrylic acid * a subject who is sensitive to electrical devices * a subject who are uncooperative to mri process
3d printed oral stents for patients with head and neck cancer receiving radiation therapy

Conditions: Malignant Head and Neck Neoplasm

Summary: this trial studies how a customized 3d-printed oral stent compares to a standard stent made by a dentist for use in imaging scans in patients with head and neck cancer receiving radiation therapy. oral stents are designed to help prevent radiation-related side effects while receiving radiation therapy. traditional oral stents are created by dentists, require at least 2 separate appointments, and may not be as cost-effective. a customized, 3d-printed oral stent may perform as well as a standard stent made by a dentist and have a significantly shorter turnaround to device delivery.

primary objectives: i. to evaluate whether a customized 3 dimensional (3d) printed oral stent achieves non-inferior levels of patient reported outcomes as the standard dental-fabricated oral stents at the time prior to starting treatment. secondary objectives: i. to evaluate the performance of the 3d stent on imaging parameters (i.e. mandibular and soft tissue displacement) for degree of normal tissue sparing. ii. evaluate the levels of patient reported outcomes after patients have developed side effects from radiation treatment. iii. to evaluate the commercially available truguard oral cavity positioning system. outline: patients wear a customized 3d printed oral stent over 5-10 minutes in the supine position at the time of radiation simulation, before starting radiation therapy, and in the 3rd to 5th week of radiation therapy. patients may also optionally wear the commercially-made stent called truguard at these timepoints.

Eligibility criteria:
inclusion criteria: * patient is dispositioned to receive definitive or adjuvant radiotherapy for treatment of a diagnosed head and neck malignancy. * treating radiation oncologist has determined the necessity of an oral stent and a device has been fabricated by dentistry at md anderson cancer center (mdacc). * patient has received pre-treatment imaging which includes the mandibular and maxillary dentition. * eastern cooperative oncology group performance status (ecog ps) 0-2. * signed study-specific consent form. exclusion criteria: * no pre-treatment computed tomography (ct) imaging including the maxilla and mandible is available. * prior head and neck radiotherapy. * severe trismus with an incisal opening of \< 10 mm. * inability to comply with the study procedures. * patients who have received dental stents fabricated outside of mdacc.
trip-patch vs duplex

Conditions: Erectile Dysfunction

Summary: to measure saturation and desaturation of the cavernosal tissue with a cutaneous placed penile sensor, before and during full rigidity. to validate discriminating sensor-readings between flaccid state and full rigidity of the penis

to measure saturation and desaturation of the cavernosal tissue with a cutaneous placed penile sensor, before and during full rigidity. to validate discriminating sensor-readings between flaccid state and full rigidity of the penis

Eligibility criteria:
inclusion criteria: * indication for a penile duplex in our andrology clinic signed informed consent male between 18-60 year exclusion criteria: * patients who are unwilling to sign written informed consent * patients unable to undergo a duplex of the penis * patients with sickle cell anemia because this could affect the accuracy of the measurements

Keywords: rigiscan erectile dysfunction
the safety and effectiveness of mk0476 (montelukast) in patients with chronic asthma (0476-388)

Conditions: Chronic Asthma

Summary: this study will test the safety and effectiveness of a range of doses of mk0476 (montelukast) compared to placebo on improved lung function in patients with chronic asthma.


Eligibility criteria:
inclusion criteria: * a person is 15 to 65 years of age. a person has had chronic asthma for at least one year exclusion criteria: * a person is a smoker or has smoked more that a pack a day for more than 10 years before stopping * a person has other lung disorders such as copd (chronic obstructive pulmonary disorder)

Keywords: chronic asthma
a study to assess efficacy and safety of resp301 plus standard of care (soc) compared to soc alone in hospitalized participants with covid-19

Conditions: COVID-19

Summary: the effect of resp301 as an add on treatment to soc will be evaluated for its efficacy in reducing rate of progression to a more severe level of covid-19 and for safety, by comparison with soc alone in hospitalized covid-19 patients.

this is an open-label, randomized, multicenter, parallel group, concurrent, controlled study using a sequential adaptive design to evaluate the efficacy and safety of resp301 plus soc versus soc alone in hospitalized patients with covid-19 (world health organization \[who\] ordinal scale level 3 or 4). approximately 300 participants will be enrolled and randomized 2:1 to the investigational arm or the control arm. the study will be divided into the following periods: screening period: (up to 2 days), intervention (up to 10 days), follow-up (day 14 and day 28).

Eligibility criteria:
inclusion criteria: 1. participant has laboratory-confirmed sars-cov-2 infection as determined by reverse transcriptase polymerase chain reaction (rt-pcr) or other approved clinical testing prior to randomization. 2. participant is hospitalized in relation to covid-19, requiring supplemental oxygen to maintain spo2 at a safe level (who level 3 \& 4). 3. participant is capable of giving signed informed consent 4. participant is male or female. all females of childbearing potential, including pregnant females, must consent to urine pregnancy testing at screening to be eligible for the study. exclusion criteria: 1. rapidly deteriorating or likely to require escalation to high flow oxygen, invasive or non-invasive ventilatory support within 24 hours according to investigator's opinion. 2. unable to safely receive a nebulized treatment for approximately 8 minutes according to investigator's opinion. 3. unable to receive or considered ineligible for invasive or non-invasive ventilatory support. 4. history of methemoglobinemia. 5. presence of uncontrolled asthma, history of severe bronchospasm. 6. presence of severe chronic respiratory disease and tracheostomy. 7. suspected or confirmed untreated, active tuberculosis. 8. severely immune-compromised participants in investigator's opinion. 9. recent active coronary artery disease or decompensated heart failure.