Kornimate/medical-research-clean huggingface dataset:
analysis of tokuhashi score

Conditions: Cancer; Metastases

Summary: 70% of all cancer patients develop some form of visceral (internal organs) or skeletal metastases (spread of disease). approximately one third of cancer patients develop metastases to the spinal column. the prognosis once spinal metastases have been diagnosed and the most appropriate treatment still remains controversial. to date there is no one good diagnostic tool to predict survival and/or outcome after radiotherapy or surgical intervention. tokuhashi, et al, formulated and presented a preoperative scoring system to evaluate indications for surgery and predict outcome in patients with metastases to the spinal column. six variables are measured to calculate this score: general medical condition, number of extraspinal metastases, number of vertebral metastases, status of metastases to the major internal organs, primary tumor type, and presence of a neurologic deficit. this scoring system has been gaining acceptance in literature. in 1998, tokuhashi, et al, modified this scoring system by diversifying the tumor types into six categories. after a retrospective analysis tokuhashi reported that patients with scores less than or equal to 8 will die of their disease within 6 months and those with scores of 12 or greater will survive an average of 12 months or more. the purpose of this study is to determine 1) the tokuhashi score's validity in predicting survival after developing spinal metastases, 2) the relationship of treatment on survival after detecting spinal metastases in relation to the tokuhashi score. patients will be enrolled into the study and followed prospectively for as long as possible regardless of intervention. there will be three groups based on their tokuhashi score, each group will require approximately 163 subjects statistically.

all info is in brief summary

Eligibility criteria:
inclusion criteria: * all patients diagnosed with any form of spinal metastases, whether symptomatic or not, regardless of tumor biology, and seen by a physician in the department of orthopedic surgery, will be asked to enter this trial. * must be a patient of our practice exclusion criteria: * there is no exclusion criteria

Keywords: cancer patients with metastases to the spinal column
the effect of marketing variable on effect of active drugs

Conditions: Pain

Summary: the efficacy of the placebo effect has been proved in many prior studies by comparing the symptoms and measures of patients. placebo has been proved to help in treating illnesses such as depression, stomach ulcer and chronic headaches. a meta analysis checked 47 studies about placebo and showed great significance when a patient is treated with placebo pill, no active substance, just by activating conditioning and expectation mechanism in his body, thus providing to the healing process, and that is it's importance. in recent years studies established a relationship between marketing variables (such as price, label) to the efficacy of a product. in addition- a unique research run in 2008 showed a significant relationship between the marketing strategies and the efficacy of medication; more specifically, patients in this research experienced less (controlled) pain when treated with placebo medication introduced to them as more expensive than patients treated with placebo medication that was introduced to them as much cheaper. all patients were treated with the exact same medication. in the investigator's experiment the investigators design a laboratory experiment to determine if marketing factors could invoke the placebo effects described earlier. for the initial laboratory experiment, we decided to examine the difference in price, on the efficacy of an otc analgesic through the mediation of low- voltage electrical pulses to the patient's wrist. the investigators study hypothesis is that marketing variables such as price and brand name will affect the therapeutic efficacy of an analgesic, i.e. a medicine will have greater influence when the patient is aware of its price compared to one who is not.


Eligibility criteria:
inclusion criteria: * healthy volunteer participants will be between the ages of 18 and 65 exclusion criteria: * candidates who have had a history of cardiac problems, epilepsy, diabetes, or are pregnant will be excluded. * taking no pain medication at the time of the experiment.

Keywords: placebo effect; pain; analgesic; electrical shock control in healthy volunteers
retrospective observational study about long-term effect of fampridine in patients with multiple sclerosis

Conditions: Multiple Sclerosis

Summary: mobility problems in multiple sclerosis (ms) is a frequent symptom. it might appear in almost 93% of patients in the first 15 years of the disease, being a clear problem for their normal living. nevertheless, therapeutic options for this symptom are few and optimal for only some patients.

the mechanism of action of fampridine has a direct effect on mobility and it´s based on voltage-dependent potassium channels functioning, causing an improvement of conductivity of action-potential in neurons. this is why nowadays is the only approved drug to treat walking and mobility problems in ms. results obtained after phase iii randomized clinical trials proved improvement in walking ability measured using the timed 25 walking feet test (t25wf). there are few studies regarding fampridine effects on symptoms different from mobility. the enable phase vi study found the first data related with the long-term impact of this treatment in physical and psychological function in patients according to their own perception. results from this study indicated that, after one year of treatment, patients perceived a sustained benefit in their health, both physical and psychologically.

Eligibility criteria:
inclusion criteria: * patients with multiple sclerosis with fampridine treatment exclusion criteria: * none
food effect study of brexpiprazole once-weekly (qw) formulation in patients with schizophrenia

Conditions: Schizophrenia

Summary: to investigate the effect of food on the pharmacokinetics of a single dose of brexpiprazole qw formulation.


Eligibility criteria:
inclusion criteria: * patients with a diagnosis of schizophrenia based on dsm-5® at the time of informed consent * patients who are able to be hospitalized for the protocol-defined hospitalization period * patients with a body mass index \[bmi = body weight (kg)/height (m)²\] of 18.5 kg/m² or higher and lower than 35.0 kg/m² at screening * patients who, in the judgment of the investigator, have stable psychotic symptoms maintained by administration of an antipsychotic within the dosing range indicated below, before commencement of imp administration \[upper limit of dose and regimen\] antipsychotic medication comprising no more than 2 active components, and a daily dose equivalent to ≤600 mg/day of chlorpromazine * patients who are able to finish the high-fat meal specified in this protocol within 20 minutes exclusion criteria: * patients with a concurrent mental disorder besides schizophrenia who are judged by the investigator to be unsuitable for participation in the trial * patients who have met the dsm-5® diagnostic criteria for substance-related or addictive disorder, including alcohol and benzodiazepines but excluding caffeine and tobacco, within 180 days before commencement of investigational medicinal product (imp) administration * patients who fall under any of the following criteria regarding suicidal ideation and suicidal behavior * patients who answered "yes" to question 4 "active suicidal ideation with some intent to act, without specific plan" or question 5 "active suicidal ideation with specific plan and intent" regarding c-ssrs suicidal ideation at screening (for the past 6 months) or at the period 1 baseline examination (since the last assessment) * patients who exhibited suicidal behavior on c-ssrs at screening (for the past 2 years) or at the period 1 baseline examination (since the last assessment) * patients who present a serious risk of suicide based on the judgment of the investigator * patients who have previously undergone gastrointestinal surgery that could affect pk evaluation * patients who have a clinically significant neurological, hepatic, renal, metabolic, hematological, immunological, cardiovascular, pulmonary, or gastrointestinal disorder. medical conditions that are minor or well-controlled may be considered acceptable if the condition does not interfere with safety and pk assessments. * patients who are using clozapine at the time of informed consent * patients whose clinical symptoms have worsened to the point where use of prohibited concomitant therapy or medication is required during the washout period for prior medication * patients whose cytochrome p450 2d6 (cyp2d6) phenotype is judged to be either poor metabolizers (pm) or unknown based on the results of cyp2d6 genotyping at screening
retrospective analysis of pulmonary arterial hypertension (pah) and related complications in juvenile idiopathic arthritis (jia) participants treated with biologic and non-biologic disease-modifying anti-rheumatic drugs (dmards)

Conditions: Juvenile Idiopathic Arthritis

Summary: this study is designed to analyze the frequency and incidence rate of pulmonary complications in jia participants who received biological dmards and non-biologic dmards. the participants having evidence of of a prescription or administration of one of the biologic or non-biologic dmards will be included in five different treatment groups. data from the thomson reuters marketscan® commercial claims and medicare supplemental databases will be used to estimate the incidence rate of pulmonary complications.


Eligibility criteria:
inclusion criteria: * participants with less than (\<) 18 years of age at index * continuously enrolled for greater than (\>) 6 months prior to index (baseline period) * one diagnosis of jia (714.3) on a non-diagnostic claim either during the baseline period (the complete participant record prior to the episode index will be defined as the episode baseline period) or within the first 30 days following the index date * had both medical and pharmacy benefit plus complete data availability during both baseline and follow-up periods exclusion criteria: * for biologic dmard cohorts, prior use of any qualifying biologic belonging to the biologic dmard of interest (using all available claims history) * for non-biologic dmard cohort, prior use of any non-biologic dmard or biologic dmard * any record of rituximab use in complete participant record * a prior safety event during the baseline period
targeting pregnancy-related weight gain to reduce disparities in obesity

Conditions: Pregnancy; Body Weight Changes; Behavioral; Obesity

Summary: the purpose of this study is to find out whether a technology-base healthy lifestyle program is an acceptable and effective way for african-american mothers to improve their eating and activity during pregnancy, compared to usual obstetric care. the goal of the program is to enhance the health of african-american mothers and their babies.

black women are in particular need for obesity prevention and treatment. the childbearing period represents a critical life stage of heightened vulnerability for new or persistent obesity, especially among black women, who retain 2-3 times more weight after pregnancy than white women. pregnancy weight gain is the strongest identified risk factor for retaining a substantial amount of weight after pregnancy, yet few published interventions have been effective in reducing excessive weight gain in pregnancy, particularly among low-income black mothers. the proposed research aims to meets the needs of low-income, black mothers by developing a novel pregnancy intervention that 1) focuses solely on black women, 2) incorporates black mothers' information needs, values, and social context, and 3) uses technology to facilitate participant engagement.

Eligibility criteria:
inclusion criteria: * pregnant african-american women at least 18 years of age * bmi at recruitment between 25.0-44.9 kg/m2 * singleton pregnancy * gestational age of ≤ 20 weeks as determined by last menstrual period * plan to carry the pregnancy to term and keep the baby * own a cell phone with a text messaging plan * member of facebook social networking site * able to participate in physical activity * participants must be willing to comply with all study-related procedures exclusion criteria: * 1. bmi ≤ 24.9 or ≥ 45.0 * uncontrolled hypertension (systolic blood pressure \> 160 or diastolic blood pressure \> 95 mmhg). participants with controlled hypertension on medication for at least three months are allowable. * known atherosclerotic cardiovascular disease * known congestive heart failure * known diabetes mellitus (type 1 or type 2) * uncontrolled thyroid disease. participants with controlled thyroid disease on medication for at least three months are allowable. * known cancer * any major active rheumatologic, pulmonary, hepatic, dermatologic disease or inflammatory condition requiring steroids or immune modulating medications * history of testing hiv positive * current smoker or tobacco user * current or recent history (past 6 months) of drug or alcohol abuse or dependence * participation in any weight control or investigational drug study within 6 weeks of screening * serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety for successful participation in the study * gastrointestinal disorders (gallbladder disease, crohn's disease, etc) * previous weight loss surgery * history of bulimia or anorexia

Keywords: pregnancy weight control behavioral technology-based intervention
dupilumab step-down strategy to maintain remission in adult and adolescents patients with atopic dermatitis

Conditions: Atopic Dermatitis; Eczema, Atopic

Summary: the goal of this clinical trial is to compare a step-down strategy of spacing dupilumab injections with a standard maintenance treatment in adolescents and adults with controlled atopic dermatitis (ad) for at least six months. the impact of dosage reduction strategies will be assessed with an innovative primary endpoint: the area under the curve of the weekly adct assessment.

for both groups: at inclusion visit : * patient information and signature of consent form * randomisation * previous medical history * clinical exam * recording adct, easi, iga, nrs pruritus, dlqi or cdlqi, eq-5d-5l weekly during 12 months (by patients on https://hestia.chu-nantes.fr) : * self-assessment of adct * date of dupilumab injections * batch number of dupilumab * amount of topical corticosteroids visits at m4, m8 and m12 will be performed for : * clinical exam * recording secondary end points (easi, iga, nrs pruritus, dlqi or cdlqi, eq-5d-5l) and adverse events * collect out-of-pocket expenses (m4 and m12).

Eligibility criteria:
inclusion criteria: * age ≥ 12 years * moderate to severe ad treated with dupilumab every 2 weeks * written informed consent (patient and/or person who has parental authority) * dupilumab treatment for at least one year * controlled ad (adct\<7 and iga ≤ 2) and assessed as controlled by the investigator since at least 6 months without tapering dosage of dupilumab * amount of topical treatment (tcs or calcineurin inhibitor) stable for 6 months and less than 60 g/month exclusion criteria: * patients with side effects of dupilumab * non controlled ad: adct ≥ 7 or iga ≥ 3 * female patient must not be pregnant\*, breastfeeding or considering becoming pregnant * patient under judicial protection * adults under guardianship or trusteeship
influence of intensive lipid-lowering on ffrct (the flow-promote study)

Conditions: Coronary Artery Disease

Summary: the flow-promote study is an investigator-initiated, danish multicenter study of patients with stable chest pain investigating whether lipid lowering is associated with recovery of impaired coronary flow as assessed by ct derived fractional flow reserve (ffrct).

multicenter study (4 centers in denmark), including 120 patients with stable chest pain and hemodynamically significant coronary artery disease as assessed by ffrct. by using two lipid lowering treatment strategies ("usual" vs "intensive" care) over 18 months, the effect on coronary plaque regression and flow recovery are assessed from repeated ct angiograms with plaque and ffrct analyses at 9 and 18 months.

Eligibility criteria:
inclusion criteria: 1. symptoms suggestive of stable coronary artery disease (cad) 2. no known cad 3. at least one coronary stenosis with \>49% lumen reduction determined by ct angiography 4. sinus rhythm 5. at least one lesion with ffrct \<0.81 (see below) 6. life expectancy \>3 years 7. fertile women must use safe contraception throughout the study period 8. signed informed consent 5. ldl cholesterol \>2.0 mm (patients already on lipid lowering medical therapy \< 3 months can be included if meeting all of the above mentioned criteria) exclusion criteria: 1. unstable angina 2. known cad 3. body mass index \>40 4. allergy to iodinated contrast media 5. known statin intolerance 6. poor coronary ct angiography image quality inadequate for ffrct calculation (determined by core-laboratory) 7. significant left main coronary artery (stenosis \>49%) or three-vessel cad determined by coronary ct angiography leading to direct referral to ica 8. ffrct \<0.81 over the left main coronary artery or the proximal left anterior descendens artery (lad) segment, or \<0.76 over the mid-lad, proximal circumflex, right coronary artery or intermediate coronary segments 9. pregnancy (women with age \>45 will be screened for pregnancy) 10. moderate to severe liver failure 11. estimated glomerular filtration rate (egfr) \< 60 ml/min 12. participation in another trial 13. does noes not wish to participate

Keywords: coronary artery disease, fractional flow reserve
pedobarographic assessments of clubfoot treated patients

Conditions: Clubfoot

Summary: the purpose of this study is to determine the utility of pedobarographs in evaluating clubfoot post-treatment.

detailed description: using tekscan's hrmat pressure assessment system or emed pedobarography system the distribution of force will be measured across the plantar surface of the subject' foot. the tekscan system is comprised of a 50 cm square pressure sensor connected to a computer interface. the data collection will be made up of two parts: part i: static profile: the child will be asked to stand on the mat for 6 seconds for five trials. during this time the data collection software will collect force data across the foot 60 times per second. the software will then calculate centre of force as well as changes in pressure during the static trial. the foot will be assessed into the distribution of forces across the hindfoot, midfoot, forefoot, and the big toe. in addition, the centre of gravity will also be determined. part ii: dynamic profile: the dynamic test will involve the child walking across the mat for a total of 5 passes per foot. measurements of force will again be taken at 60 hz. the emed-x400 sensor is rectangular and its dimensions are 47.5 cm by 32 cm. measurements of force will be recorded at up to rates of 400 hz. foam pieces (included with the emed platform) are constructed around the platform to establish a levelled and safe runway for the patient to walk along. the emed platform is connected to a computer interface which operates on the novel analysis software. the subject will be asked to walk across the mat independently at their ordinary pace. the foot is required to land in the centre of the mat, at a minimum of three trials per foot10. plantar pressure recording takes 10-20 minutes for each subject.

Eligibility criteria:
inclusion criteria: inclusion criteria - all clubfoot patients seen at bc children's hospital who have commenced walking and compliant to the study protocol. as the goal of the study is to evaluate the utility of pedobarographs in evaluating clubfoot treatment, we will be following subjects with all presentations of clubfoot (this includes idiopathic clubfoot and clubfoot that is secondary to another global disorder). exclusion criteria:

Keywords: evaluation of an outcome tool clubfoot foot pressure profiles pedobarographs
metformin and systemic inflammation in hiv

Conditions: PreDiabetes; HIV-1-infection

Summary: the purposes of this study are to find out if: metformin can be combined with anti-hiv drugs to reduce systemic inflammation measured by the determination of cytokines and other series of serum markers. to determine if the concomitant administration of metformin with tara improves the immune function on the cd4 t cell count and its relation with the cd8 t cells, during the treatment and after its interruption. to this end, in the present study, patients with prediabetes (who meet the fasting impaired glucose criteria) will be identified and treated with metformin or placebo for 8 weeks, receiving stable tara and with a cd4 + level\> 200 cells / μl. 40 patients from the hiv unit of the civil hospital of guadalajara "fray antonio alcalde" will be included in this study and the intervention will last 8 weeks.


Eligibility criteria:
inclusion criteria: * both sexes, * age ≥18 years of age * with a diagnosis of hiv-1 infection, * that they are receiving tare for at least 12 months (time necessary to establish a stable reservoir), * patients with undetectable viral load (\<40 copies / ml) for at least 12 months, * have a cd4 + level\> 200 cells / μl, * that they do not have a diagnosis of co-infection with hcv or hbv, * patients who do not have a severe alcohol intake (\<21 glasses / week in men and \<14 glasses / week in women), * patients who do not use drugs during the last 90 days prior to the screening visit, or during the study, * who wish to participate voluntarily in the study and give their written consent. exclusion criteria: * individuals with a known hypersensitivity / allergy to metformin. * patients with contraindications to the use of metformin \*. * individuals who are actively involved in an experimental therapy study or who have received experimental therapy in the last 6 months. * people suffering from stage iv-v chronic kidney disease, uncontrolled heart failure or active infections. * individuals with diabetes mellitus (according to the criteria of the american diabetes association \*). * patients with indication for the use of statins, aspirin or immunomodulators.