Kornimate/medical-research-clean huggingface dataset:
virtual reality-based training in cerebellar ataxia

Conditions: Cerebellar Ataxia

Summary: the purpose of this study was to investigate the effects of virtual reality-base training for cerebellar ataxia.


Eligibility criteria:
inclusion criteria: * diagnosis of sca 1, 2, 3 and 6 by a neurologist * ability to walk independently with or without any walking aids * age ≥ 20 * a score of ≥ 24 on the mini-mental state examination exclusion criteria: * histories of other neurological, cardiovascular, or orthopedic diseases affecting motor performance and balance * uncontrolled chronic diseases
trial for evaluation of safety of escalating dose levels of medi-507 in patients for treatment of at least grade ii graft-versus-host disease (gvhd)

Conditions: Graft-Versus-Host Disease

Summary: a trial to assess safety of four doses of medi 507 combined with another drug for initial treatment of at least grade ii acute graft-vs-host disease in recipients.

the primary objective of this study is to assess safety of four dose levels of medi 507 combined with methylprednisolone for initial treatment of at least grade ii acute gvhd in stem cell or bone marrow allograft recipients.

Eligibility criteria:
inclusion criteria: 1. allogeneic bone marrow or hematopoietic stem cell graft recipients 2. acute gvhd of at least grade ii severity 3. receipt of at least 2 mg/kg of methylprednisolone (or equivalent corticosteroid) within eight to 24 hours prior to initial receipt of study drug 4. evidence of engraftment (anc over 1,000 cells/mm3) 5. histologic evidence of gvhd from biopsy performed during the current episode 6. receipt of gvhd prophylaxis of methotrexate, tacrolimus or cyclosporine 7. age at least 18 years 8. body weight under 130 kg 9. both males and females are eligible, but females of childbearing potential, unless previously surgically sterilized, agree to use an effective method of birth control (e.g., abstinence, intrauterine contraceptive device, oral contraceptives, diaphragm or condom in combination with contraceptive jelly, cream or foam, norplant7 or depoprovera7) beginning with the first study injection and continuing through 60 days after the final study injection. exclusion criteria: 1. previous receipt of medi 507 2. diagnosis of chronic gvhd 3. previous treatment with any anti-t-cell monoclonal antibodies such as okt73 or daclizumab (zenapax7) 4. receipt of antithymocyte globulin (atgam7 or other atg) within 14 days 5. treatment with more than 0.3 mg/kg/day of methylprednisolone (or equivalent corticosteroid) for more than 72 hours for the treatment of gvhd 6. intolerance or history of intolerance to corticosteroids such that it is unlikely the patient will be able to complete at least ten days of corticosteroid therapy (2 mg/kg/day of methylprednisolone or equivalent) 7. more than one allogeneic bone marrow or hematopoietic stem cell allograft
cognitive retraining and brain stimulation for alcohol use

Conditions: Binge Drinking

Summary: the overarching goal of this study is to determine whether combined cognitive training and transcranial direct current stimulation (tdcs) reduces drinking in high-risk drinkers. to this end, specific study purposes are: 1) replicate previous findings that cognitive retraining reduces drinking levels, 2) test whether cognitive retraining can be enhanced with tdcs, and 3) investigate the neural changes that result from cognitive retraining and tdcs. we hypothesize that those participants who receive alcohol avoidance cognitive training will have greater reductions in drinking. in turn, those participants who receive a higher level of applied tdcs during alcohol avoidance response training will have better avoidance learning, as well as, a larger reduction in drinking behavior. finally, those participants receiving a higher level of applied tdcs will have more neuronal response associated with alcohol avoidance during the brain imaging session.


Eligibility criteria:
inclusion criteria: * age 21-30 years * at least five binge drinking episodes (4+ drinks for men; 3+ drinks for women) for the past month * alcohol use disorder identification test (audit) score greater than 8 * right handed exclusion criteria: * history of treatment for alcohol dependence (ad) or desire for treatment * history of alcohol withdrawal * history of brain injury * currently taking psychotropic medications (e.g. antidepressants, antipsychotics) * female subjects who are pregnant * evidence of recent illicit drug use on a urine screen * left handed * prior participation in a brain stimulation study * implanted brain medical devices * electromedical devices * latex allergy
concomitant chemoradiotherapy (ccrt) with weekly docetaxel and cisplatin for locally advanced head and neck cancer

Conditions: Head and Neck Cancer

Summary: this phase ii trial is evaluating the efficacy of concurrent chemoradiation therapy with weekly docetaxel and cisplatin combination regimen.

many studies have shown the superiority of concurrent chemoradiotherapy over radiotherapy only in locally advanced head and neck cancer. concurrent chemoradiotherapy with high dose cisplatin has been universally used regimen. in a large-scaled phase ii trial, however, conducted by the european organization for the research and treatment of cancer (eortc), docetaxel (100mg/m2) plus cisplatin (75mg/ m2) every three weeks regimen produced improved survival, nonetheless there was significant limitation to deliver full doses of treatment due to significant hematologic and non-hematologic toxicities. previously, we showed the safety of the combination regimen of weekly docetaxel and cisplatin in concurrent chemoradiation treatment in a phase i study. we determined the mtd of docetaxel to be 20mg/m2 weekly when concurrently administered with conventional fractionation rt and weekly 20mg/m2 of cisplatin.

Eligibility criteria:
inclusion criteria: 1. histologically confirmed squamous cell carcinoma of the head and neck (scchn) of one of following sites : oral cavity, oropharynx, larynx, or hypopharynx 2. unresectable stage iii - ⅳb disease 3. previously untreated for head \& neck cancer with chemotherapy or radiotherapy 4. 18 and over 5. performance status ecog 0-1 6. absolute neutrophil count ≥ 1,500/mm3 7. platelet count ≥ 75,000/mm3 8. hemoglobin \> 9.0 g/dl 9. bilirubin ≤ 1.5 times upper limit of normal (uln) 10. ast or alt, and alkaline phosphatase meeting 1 of the following parameters:alkaline phosphatase ≤ 1.5 times uln and ast or alt ≤ 5 times uln alkaline phosphatase ≤ 2.5 times uln and ast or alt ≤ 1.5 times uln alkaline phosphatase ≤ 5 times uln and ast or alt ≤ uln 11. serum creatinine ≤ 1.5 mg/dl or creatinine clearance ≥ 60 ml/min exclusion criteria: 1. distant metastatic disease (m1) 2. prior chemotherapy or rt for head and neck cancer 3. synchronous or concurrent head and neck primary tumors 4. lip, nasopharynx, nasal cavity, salivary gland, or sinuses 5. no other invasive malignancy within the past 3 years except nonmelanoma skin cancer or papillary thyroid cancer 6. other concurrent illness that would preclude study participation 7. other concurrent physical condition (e.g., infectious disease) that would preclude study participation 8. pregnant or nursing 9. fertile patients must use effective contraception during and for 3 months after study participation

Keywords: locally advanced squamous cell carcinoma
study of canfosfamide in refractory or relapsed mantle cell, diffuse large b cell lymphoma and multiple myeloma

Conditions: Mantle Cell Lymphoma; B Cell Lymphoma; Multiple Myeloma

Summary: this is a phase 2 study to determine the efficacy and safety of canfosfamide treatment in relapsed or refractory mantle cell lymphoma, diffuse large b cell lymphoma and multiple myeloma. the study will be conducted in two stages with 5-6 patients in each indication in stage 1 and if responses are observed an additional 10 patients in stage 2 in each group.


Eligibility criteria:
inclusion criteria: * relapsed or refractory disease * histologically or cytologically confirmed disease * characteristic immunophenotypic profiles * measurable disease (for lymphoma patients) * ecog performance status of 0-2 * adequate liver and kidney function * adequate bone marrow reserves * ineligible or unwilling to undergo autologous stem cell transplantation exclusion criteria: * failure to recover from any major surgery within 4 weeks of study entry * pregnant or lactating women * women of child-bearing potential not using reliable and appropriate contraception * routine prophylactic use of g-csf required within 2 weeks of study entry * grade 3 or higher peripheral neuropathy * history of hepatitis b virus or hiv * central nervous system or meningeal involvement by lymphoma or multiple myeloma

Keywords: nhl non-hodgkins lymphoma lymphoma mantle cell diffuse large b cell multiple myeloma telcyta canfosfamide tlk286 prodrug enzyme activated drug glutathione transferase p1-1 activated drug gstp1-1 activated drug glutathione transferase activated drug glutathione glutathione analong
hiv testing strategies in the perinatal setting

Conditions: HIV Infections; Pregnancy Related

Summary: the purpose of the study is to determine whether an abbreviated pretest/post-test cdc recommended counseling is as equally acceptable to prenatal patients as the standard strategy using prenatal care nurses and medical providers at san francisco general hospital \[sfgh\]).

approximately 40% of hiv-infected infants in the united states in 2000 were born to women not diagnosed with their hiv prior to delivery. (1) there are now effective medical therapies to prevent perinatal transmission, including anti-retroviral therapy, but this requires diagnoses of maternal hiv prior to delivery. both the centers for disease control and prevention (cdc) and institute of medicine (iom) have published strong recommendations for universal hiv-antibody testing of pregnant women. this will be a randomized controlled, non-inferiority trial comparing two hiv testing strategies among english and spanish-speaking patients presenting for prenatal care at sfgh whc over the course of approximately one year. eligible participants will be randomized by study personnel to either standard hiv counseling and testing (control arm) or abbreviated counseling and testing (study arm). participants will receive a standard prenatal hiv testing brochure, undergo one of two hiv counseling/testing strategies, submit blood for an hiv-1 antibody test, and will follow-up with their medical provider for hiv test results. upon completion of counseling, participants will undergo a short, structured (pre-test) questionnaire administered by study staff. following testing and receipt of results, participants will complete a second (post-test) structured questionnaire administered by study staff. eligible women presenting to sfgh physician or midwife prenatal clinics will be recruited, consented and randomized by study staff to either the standard or abbreviated testing strategy. the outcomes studied will be patient satisfaction and the proportion of study participants who undergo hiv testing. potential confounder variables to be measured will include demographic characteristics, prior hiv testing history, knowledge about hiv/aids, attitudes towards hiv testing, hiv test result, and type of provider (physician versus midwife).

Eligibility criteria:
inclusion criteria: * women 16 years of age or above seeking prenatal care at san francisco general hospital exclusion criteria: * women who do not speak spanish or english * women younger than 16 years of age * women who obtained an hiv test during the index pregnancy prior to initiation of prenatal care at sfgh * women known to be infected with hiv at initiation of prenatal care at sfgh

Keywords: hiv seronegativity
novii external fetal monitoring device

Conditions: Pregnancy Related; Fetal Distress

Summary: this study will be conducted on women in labor. fetal heart rate monitoring will be conducting using the novii fetal ecg/emg system and comparing it to current standard of care external fetal heart rate and tocometry. these approaches will be compared with the respect to need for additional monitoring, amount of nursing intervention, cost and satisfaction of patients and healthcare providers.

interpretation of fetal heart rate monitoring during labor is one of the most common procedures performed in the practice of obstetrics. continuous monitoring of the fetal heart rate is used to identify infants at risk for hypoxic ischemic encephalopathy and allow for intervention to prevent this terrible complication. the quality of the fetal heart rate signal is critical for appropriate interpretation of the characteristics that identify risk. this is a prospective, randomized pragmatic trial comparing the novii fetal ecg/emg system to external fetal heart rate and tocometry (standard of care) for the amount of time of interpretable fetal heart rate during labor. randomization will occur in blocks based on bmi to control for the potential effect of bmi. fetal heart rate tracings from both groups of women will be reviewed in a blinded fashion by experienced maternal fetal medicine (mfm) physicians who will assess the tracing for quality and interpretability. in addition, both approaches will be compared with respect to the need for additional monitoring modalities, amount of nursing intervention, cost and satisfaction of the patients and healthcare providers.

Eligibility criteria:
inclusion criteria: * pregnant women ≥ 18 years of age; gestational age ≥ 37 weeks * singleton pregnancy. * these women will be those presenting to labor and delivery for one of the following: * rule out labor * spontaneous labor * induction of labor exclusion criteria: * age \< 18 years old; multiple gestation pregnancy; gestational age \< 37 weeks * fetal distress or vaginal bleeding prior to monitor placement * previous cesarean section * planned cesarean delivery. * women who are enrolled in the study but have less than 1 hour of fetal heart rate monitoring after randomization will be excluded from analysis.

Keywords: external fetal heart rate monitor fetal heart rate monitor
interfacial injection in low back pain

Conditions: Low Back Pain

Summary: its effect on thoracolumbar fascia and low back pain has been investigated in different studies.these studies suggest that the anatomical and histological features of the fascia may have an effect on low back pain. this study aimed to investigate the effectiveness of interfacial injection in patients with chronic back pain.


Eligibility criteria:
inclusion criteria: * low back pain for more than 6 months; * presence of mr findings radiologically diagnosing ldh; * numeric rating scale (nrs) \> 5 exclusion criteria: * spinal stenosis; * spondylolisthesis; * previous lumbar * spinal surgery
iron-deficiency anemia in infants in two weekly programs

Conditions: Anemia

Summary: this work aims at establishing the effectiveness of weekly doses of ferrous sulfate administered by mothers compared with weekly supplements administered directly by healthcare professionals, to reducing anemia prevalence.

some studies have shown satisfactory results in reducing the prevalence of iron deficiency using weekly doses of ferrous sulfate, thereby avoiding these side effects. this deficiency is the most common nutritional disorder during childhood and does not only affect individuals from developing countries but also those from industrialized nations. for infants with ages between six and 24 months, iron supplementation is the main treatment for iron deficiency. in this age range the prevalence of anemia is at least 20%. however, studies have shown a low rate of compliance by mothers during the recommended period, which may be caused by a lack of care or, more probably, due to the side effects caused by long-term daily ferrous sulfate supplementation, which include nausea, vomiting, diarrhea, staining of teeth and abdominal pain. this specific study is randomized clinical trial study, achieved in a government healthcare clinic in sao jose do rio preto, sao paulo, brazil. this study was carried out using two intervention groups. all children received 12 weekly doses of 25 mg of elemental iron, either administered in the government healthcare clinic or at the children's home. the study showed treatment compliance in both groups. prevalence of anemia for all children was 75% at the beginning of supplementation and 46.3% at the end of the period (p \< 0.0005). reduction rate for anemic children was 38.3%. average increases in hemoglobin concentration levels were 0.75 g/dl and 0.65 g/dl, respectively, for home interventions and healthcare clinic administration (p \< 0.00005).

Eligibility criteria:
inclusion criteria: * ages ranging between six and 24 months old exclusion criteria: * positive results for the guthrie test * use of ferrous sulfate supplements * infections process at the time of first consultation

Keywords: infants prevalence iron deficiency treatment
post discharge circadian rhythms post adenotonsillectomy

Conditions: Circadian Dysrhythmia

Summary: the purpose of this study is to utilize non-invasive, easily measurable biomarkers (heart rate, skin temperature, sleep, and activity) in the post surgical discharge period to identify trends which correlate with improved outcome and early recovery (return to baseline activity). these are measured (captured) utilizing a wearable technology (wt) device. return to baseline (rtb) activity for the purpose of this study is defined primarily as step count normalization as a surrogate of activity (pre versus post operative step count), and heart rate variability normalization back to preoperative baseline. increased heart rate variability has been studied in acute care settings as a marker of poor prognosis. please note that return to baseline is not defined for the pediatric population in the same way as adults (which is primarily questionnaire based and not applicable in children).

wearable technology has tremendous advantages over current methods of assessing rtb activity in the post-discharge pediatric population after at, which rely on quality of life (qol) scales, caregiver and patient reports, as well as nurse phone calls and office visits. these methods are biased, time and labor intensive, disease focused, and caregiver dependent. the investigators propose to use wearable technology in order to assess rtb activity. the device has validated methodology in sleep metrics (as compared to polysomnography), heart rate and activity monitoring (optical sensor and 3 plane accelerometry), and temperature measuring (galvanic skin resistance). so far, no investigators have utilized wearable technology and biomarker (heart rate, skin temperature, activity, sleep) data in the manner proposed. rtb is a difficult to measure entity in children and the investigators have defined it using step count as a marker of activity. there are no studies or "standard" to measure quality of recovery in children.

Eligibility criteria:
inclusion criteria: * as stated previously, osa v. non osa exclusion criteria: -
therapeutic metabolic intervention in patients with spastic paraplegia spg5

Conditions: Spastic Paraplegia, Hereditary

Summary: the purpose of this project is to study the efficacy of three candidate molecules (xenbilox, tahor and resveratrol) in order to decrease the production of oxysterols by reducing the synthesis of cholesterol and/or regulate the production of bile acids and/or enabling neuroprotective action within the motor neuron.

the primary objective of the study is: - decrease the accumulation of metabolites which can have a negative impact on neurological and systemic function of patients with spg5. the secondary objectives of the study are: * confirm the clinical and biological tolerance of the different candidate molecules under study * improve the serum bile acid profile of patients with spg5

Eligibility criteria:
inclusion criteria: * patients that have confirmed through genetic testing their status as carriers of 2 mutations in the cyp7b1 gene * age ≥ 18 years * patients that have signed the informed consent form * presence of health care coverage exclusion criteria: * known hypersensitvity to chenodeoxycholic acid, atorvastatin, resveratrol or to any of their byproducts * cholesterol lowering medications other than the study treatment * hepatic failure with transaminases \>3 times the normal level * progressive biliary pathology * chronic diarrhea * serious mental illness * significant comorbid neurological disorder * incapacity to understand information about the protocol * unwilling or unable to participate in any part of the study * participation in another clinical trial during the study period * person deprived of liberty by judicial or administrative decision * adult subject under legal protection or unable to consent * pregnant or breastfeeding women * lack of health care coverage * absence of a signed informed consent form

Keywords: spastic paraplegia metabolism oxysterols neurogenetics
biomarkers and choroidal neovascularization

Conditions: Choroidal Neovascularization; Mineralocorticoid Excess

Summary: the aim of the study is to find biomarkers in the blood and aqueous humor of patients with type 1 choroidal neovascularization and correlate them with the response to anti-vegf treatment.

age-related macular degeneration (amd) is the most frequent cause of blindness in industrialized countries. multiple molecular pathways have been implicated in the pathogenesis of choroidal neovascularization (cnv). currently, the treatment relies on neutralization of vegf (vascular endothelial growth factor). however some patients have an incomplete response to anti-vegf treatment. a recent study suggested the implication of the mineralocorticoid receptor pathway in the formation of cnv. the study (of investigators) aim is to evaluate the concentation of metabolites of mr pathway in the blood and aqueous humor of patients with cnv and compared them with patients without cnv in order to increase our understanding of cnv pathogenesis and find potential biomarker of response to anti-vegf treatment.

Eligibility criteria:
inclusion criteria: patients of group 1: * patients with type 1 choroidal neovascularization in a context of central serous chorioretinoathy or age related macular degeneration * patients without intravitreal injection or last intravitreal injection \> 3 months * informed signed consent patients of group 2: * patients without choroidal neovascularization * patients with intraocular surgery (cataract or vitrectomy surgery) * signed consent exclusion criteria: * myocardial infarction \< 12 months * chronic renal failure * inflammatory disease * infectious disease :hiv, viral hepatitis, tuberculosis * type 1 or 2 diabetes * patients treated by mineralocorticoid antagonist treatment. * type 2 or 3 choroidal neovascularization * pregnant woman

Keywords: central serous chorioretinopathy age related macular degeneration biomarker