Kornimate/medical-research-clean huggingface dataset:
topiramate augmentation in bulimia nervosa partial responders

Conditions: Bulimia Nervosa

Summary: the goal of this study is to generate pilot data exploring the addition of an augmentation (additional) medication to patients suffering from bulimia nervosa who have responded but not had complete symptom resolution with a course of standard medication treatment.

the aim of this study is to determine whether the addition of an augmentation medication (topiramate 200mg/d) will confer additional reductions in symptomatology in bn patients who have received six weeks of standard pharmacological treatment with fluoxetine 60 mg/day or its equivalent and had a partial response but are not in symptomatic remission.

Eligibility criteria:
inclusion criteria: * male or female subjects meeting diagnostic and statistical manual iv edition (dsm-iv) diagnostic criteria for bulimia nervosa (bn). * subjects must be between the ages of 18 and 60 years. * subjects must currently demonstrate partial response to a standard bn pharmacotherapy treatment. * women of child-bearing potential must be practicing an accepted method of birth control (barrier method or oral contraceptive) and have a negative pregnancy test at baseline. * subjects must be of good general health by history, laboratory assessment and physical exam. * subject's bmi must be \>20 and \<27 kg/m\^2. exclusion criteria: * subjects who are allergic to topiramate. * subjects who meet dsm-iv criteria for anorexia nervosa. * women who are pregnant or nursing at the time of study. * subjects experiencing clinically significant, unstable neurological, cardiac, hepatic or renal disease or narrow angle glaucoma. * subjects with a history of nephrolithiasis. * subjects with a serum potassium \<3.0 mmol/l * subjects cannot start psychotherapy during the study. * subjects currently or with a past history of meeting dsm-iv diagnostic criteria for schizophrenia, schizoaffective disorder, or bipolar disorder. * subjects receiving antipsychotic agents, mood stabilizers, antianxiety agents or other non-antidepressant psychotropic agent currently. * subjects currently or with a history within the past year of meeting dsm-iv diagnostic criteria for substance abuse. * subjects who are experiencing clinically significant suicidal ideation (subjects will be referred to appropriate caregiver). * subjects who have participated in an investigational drug study in the past 30 days. * subjects who are receiving any prescription medications other than oral contraceptives that will interact with any of the study medication.

Keywords: bulimia nervosa topiramate augmentation
sc12267 (4sc-101) in combination with methotrexate in patients with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the purpose of the study is to determine the efficacy, safety and pharmacokinetics of sc12267 (4sc-101, 35 mg) in combination with methotrexate in comparison to methotrexate alone in the treatment of patients suffering from rheumatoid arthritis.


Eligibility criteria:
main inclusion criteria: * patients with active ra of functional classes i, ii or iii according to the criteria of american rheumatism association for ra * das28(esr) ≥ 4.5 (das28 formula with 4 variables using esr) * patients who have received weekly doses of mtx (10-25 mg/week) for a minimum of 3 months prior to day 1 dosing, and who have received a stable mtx dose of 10-25 mg/week without any change in route or change in folic acid supplementation for at least 6 weeks prior to day 1 dosing * patients may receive up to 10 mg/day of oral prednisolone or steroid equivalent. dose must have been stable for at least 30 days and must not be changed during the washout, screening and treatment periods, unless dictated by tolerability requirements main exclusion criteria: * patients with ra of functional classes iv according to the criteria of american rheumatism association for ra * patients who have received any of the following treatments must abide by the indicated washout period: 1. leflunomide requires a 6 month washout period prior to day 1 dosing 2. oral or injectable gold, azathioprine, penicillamine, anakinra require a 30 day washout period prior to day 1 dosing 3. cyclosporine, abatacept, etanercept, adalimumab, infliximab, and rituximab require a 60 day washout period prior to day 1 dosing 4. cyclophosphamide requires a 180 day washout period prior to day 1 dosing 5. parenteral or intra-articular corticosteroids require a 30 day washout period prior to day 1 dosing * receipt of the following drugs within 4 weeks prior to dosing: 1. sulfasalazine 2. hydroxychloroquine 3. use of corticosteroids \> 10 mg/day

Keywords: rheumatoid arthritis sc12267 4sc-101 methotrexate phase ii
safety and efficiency of γδ t cell against breast cancer(her-, er-, and pr-)

Conditions: Breast Cancer

Summary: in this study, effects of γδt cells on human breast cancer (her2-, er-,pr-) in combination with tumor reducing surgery, for example cryosurgery going to be investigated.

breast tumor will be removed using tumor reducing surgery such as cryosurgery. pbmc of the patient will be separated from peripheral blood. after making them potential cancer killer γδ t cell and dc-cik, they will be infused to the patients as immunotherapy.

Eligibility criteria:
inclusion criteria: 1. age:18-75 2. karnofsky performance status \>50 3. diagnosis with breast tumors based on histology or the current accepted radiological measures. 4. classification tumor,nodes,metastasis-classification(tnm) stage: ⅱ,ⅲ,ⅳ 5. will receive cryosurgery, gd tcells/ dc-cik. 6. life expectancy: greater than 3 months 7. ability to understand the study protocol and a willingness to sign a written informed consent document exclusion criteria: 1. patients with other kinds of cancer 2. history of coagulation disorders or anemia 3. patients with heart disease and diabetes

Keywords: γδ t cell breast cancer her2- er- pr-
efficacy and safety study of me-609 and acyclovir for treatment of herpes simplex labialis

Conditions: Herpes Labialis

Summary: the purpose of this study is to determine whether me-609 is more efficient than acyclovir and placebo for the treatment of recurrent herpes labialis.

this was a randomized, double-blind, active- and vehicle-controlled study comparing the effects of me-609, acyclovir in me-609 vehicle, and vehicle alone. treatment was subject-initiated within 1 hour of experiencing the first signs or symptoms of a herpes recurrence. the subject visited a study clinic as soon as possible after treatment initiation, but no later than midnight of the following day, for evaluation.

Eligibility criteria:
inclusion criteria: * generally good health * history of recurrent herpes labialis with at last three episodes during the prior 12 months exclusion criteria: * treatment with antivirals or immunosuppressive agents within 2 weeks prior to randomization * pregnant and/or nursing women * continuous daily treatment with pain medication * significant skin condition that occur in the area of herpes recurrences
study of cetuximab to treat gastric cancer

Conditions: Gastric Cancer

Summary: the purpose of this study is to evaluate the efficacy and safety of cetuximab combined with folfiri in patients with advanced gastric cancer who failed first-line chemotherapy

up to now, although fu based, cisplatin based and taxane based regimen, and ecf regimen have been suggested as the first line therapy for a/mgc by fda, there is no standard regimen for patients with a/mgc as second line treatment. based on the promising results of cetuximab combined with folfiri in metastatic colorectal cancer, we design this clinical trial to evaluate the efficacy and safety of cetuximab combined with folfiri for a/mgc patients as a second line treatment.

Eligibility criteria:
inclusion criteria: * histologically confirmed advanced or metastatic adenocarcinoma of the stomach * ecog performance scale ≤ 1 * at least one measurable lesion (larger than 10 mm in diameter by spiral ct scan) * adequate hepatic, renal, heart, and hematologic functions (platelets\>80 × 109/l, neutrophil\>2.0 × 109/l, serum creatinine ≤ 1.5mg/dl, total bilirubin within upper limit of normal(uln), and serum transaminase≤2.5×the uln) exclusion criteria: * pregnant or lactating women * concurrent cancer * history of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix * neuropathy, brain, or leptomeningeal involvement * uncontrolled significant comorbid conditions and previous radiotherapy

Keywords: time to progression toxicity overall survival response rate quality of live
dexmedetomidine dosage for postoperative delirium and cognitive function in elderly tka patients

Conditions: Post Operative Delirium

Summary: this study aims to evaluate the efficacy of dexmedetomidine in reducing the incidence of postoperative delirium and cognitive dysfunction in elderly patients undergoing total knee arthroplasty (tka). the study will compare the outcomes of patients receiving dexmedetomidine to those receiving a standard anesthetic or sedative, focusing on factors such as patient characteristics, surgical duration, and postoperative care. the research will explore the potential neuroprotective effects of dexmedetomidine and its ability to mitigate the risks associated with anesthesia and surgery in vulnerable elderly populations.


Eligibility criteria:
inclusion criteria: * patients with severe chronic knee osteoarthritis inducing limitation of movement and required knee replacements; * patients of american society of anesthesiologists classification grades ii-iii; * patients free of exclusion criteria. exclusion criteria: * patients of american society of anesthesiologists classification grade \>iii; * patients show a high risk for getting post operative delirium or have severe cognitive dysfunction; * patients had a history of uncompensated cardiac, renal, or hepatic diseases; * patients had uncontrolled diabetes mellitus or hypertension; * patients had other causes for limited movement; * patients had autoimmune disease, coagulopathy, severe anemia with a hemoglobin concentration of \<7 g%; * patients had local bone disorders that may prevent prosthesis stability; * patients had allergies or contraindications to the study drugs.
a mindfulness approach to ua for afro-descendants

Conditions: Anxiety; Stress

Summary: the goal of this clinical trial is to test an app-based mindfulness training program in an afro-descendant population. the main question\[s\] it aims to answer are: * what changes, if any, does the app need? * is it effective in reducing anxiety among this population? participants will be asked to: * use an app-based mindfulness training program daily * complete online surveys at baseline and 2 months post-treatment initiation * complete focused interviews via zoom at baseline and 2 months post-treatment initiation * complete daily voice diaries via zoom


Eligibility criteria:
inclusion criteria: * gad-7 ≥ 10 * self-identify as black american and/or afro-descendant * located in united states or canada * able to speak english * owns a smartphone exclusion criteria: * any usage of psychotropic medication: not on a stable dosage 6+ weeks * as needed (i.e., prn) benzodiazepine use * psychotic disorder (e.g., bipolar disorder, schizophrenia, schizoaffective disorder, psychosis) * cohabiting with a study participant

Keywords: worry
norwegian occipital ischemic stroke study

Conditions: Ischemic Stroke; Visual Field Defect

Summary: patients who suffer an ischemic stroke in the occipital lobe often experience visual field defects. visual field defects are negatively correlated to falling, institutionalisation, rehabilitation outcome and quality of life. patients are often not properly examined and seldom receive rehabilitation. nor-occip aims to evaluate the natural history of visual field defects after occipital infarction and to determine whether rehabilitation is effective.

background: visual field defects after cerebral infarction is an increasingly acknowledged problem, which has consequences for patient outcome. the aim of the norwegian occipital ischemic stroke study (nor-occip) is to: 1.) improve clinical diagnostics and management of visual field defects in occipital stroke. 2.) identify and estimate the need for visual rehabilitation among patients with vfd by studying the natural course and the rate of spontaneous recovery. 3.) study the effect of visual rehabilitation both on visual function as well as on quality of life. methods: patients with acute ischemic occipital stroke on mri are recruited from bergen, stavanger and trondheim. patients are included for a period of 1.5 years, starting august 15th 2013. patients are eligible for inclusion if \>18 years, written consent is obtained and the patient is able to co-operate to examination with autoperimetry. within one week patients are examined by ophthalmologist after a standardized protocol including autoperimetry. during week four patients are examined by vision teacher after a standardized protocol and a structured interview on vision specific function and quality of life (vfq-25) is conducted by a study nurse via telephone. if visual rehabilitation is provided by the municipality in which the patient lives, the patient will be referred to such. eye examination including autoperimetry, vision teacher assessment and vfq-25 is repeated after 6 months. all patients will be registered in the national stroke registry, and the following variables will be analysed: demographic variables, lifestyle factors, clinical status at admission (scores on nihss), clinical status at discharge and 3 months post-stroke (scores on modified rankin scale). so far 62 patients have been included. limited research exists on visual impairment after cerebral infarction. it is important to establish the natural course of visual impairment after ischemic stroke, and to evaluate the effect of visual rehabilitation.

Eligibility criteria:
inclusion criteria: * written consent obtained, * age \>18, * acute occipital infarction on brain imaging and ability to cooperate for examination with autoperimetry exclusion criteria: * pathological processes that severely affect eyesight.
exploring disease immunogenicity and the immunological effects of hypomethylating agents in acute myeloid leukemia

Conditions: Acute Myeloid Leukemia

Summary: this is a multicenter, prospective, translational study, to evaluate the immunogenic profile of aml cases according to immune checkpoint molecule expression.

this is a multicenter, prospective, translational study. pharmacological treatments will not be object of the present study. patients will follow the prescribed therapeutic indications according to regular clinical practice. biological samples and clinical data will be collected at fixed timepoints. aim of the study is to evaluate the immunogenic profile of aml cases according to immune checkpoint molecule expression. a total of 75 aml patients affected by primary or secondary aml, at diagnosis ( 45 patients) or relapse (30 patients) will be enrolled in the protocol (18 months for patient enrolment). blood,bm and saliva samples will be collected from each patients; for patients enrolled at diagnosis, samples will be collected before and after treatment with hypomethylating agents.

Eligibility criteria:
inclusion criteria: 1. patients with new diagnosis of primary or secondary aml candidate to first line treatment with hypomethylating agents (specific for cohort 1) patients with primary or secondary aml who relapse after/during first line treatment with hypomethylating agents (specific for cohort 2) for each cohort: 2. participant is willing and able to give informed consent for participation in the study 3. male or female, aged \>18 years 4. availability of clinical data exclusion criteria: 1. age \< 18 years 2. aml m3 subtype according to fab classification

Keywords: aml acute myeloid leukemia immunogenic profile transcriptome analysis
a trial of the irradiance level of phototherapy for neonatal jaundice

Conditions: Neonatal Jaundice

Summary: the aim of this trial is to show that the low irradiance level is not worse than the high irradiance level in the phototherapy for neonatal jaundice.

neonatal jaundice is a commonly disease. phototherapy is performed to prevent from kernicterus.however, light sources and irradiance level are different among hospitals, and it was controversial whether the improvement of jaundice is related to the irradiance level of phototherapy or not. in addition, long-term side effects are not clear, therefore, excessive irradiation should be avoided. the purpose of this study is to show that the low irradiance level is not worse than the high irradiance level in the phototherapy for neonatal jaundice. this study is multicenter randomized controlled trial conducted by nagoya university hospital, anjo kosei hospital, kasugai municipal hospital, handa hospital, toyota memorial hospital, national hospital organization nagoya medical center, japan red cross nagoya daiichi hospital, hekinan municipal hospital, and ogaki municipal hospital.

Eligibility criteria:
inclusion criteria: * asian full-term neonates with jaundice between 48 and 96 hours of age. exclusion criteria: * patients with low-birth-weight, early onset jaundice before 48 hours of age, perinatal asphyxia, antimicrobial therapy or respiratory disorders. patients with jaundice caused by hemolysis, or functional or anatomic obstruction. patients who need treatments except for phototherapy.

Keywords: neonatal jaundice phototherapy neonate
function and quality of life after emergency vs planned creation of a stoma

Conditions: Colorectal Cancer

Summary: the aim is to compare functional outcome and or quality of life in patients with a stoma that was constructed as an emergency procedure with patients where a stoma was created as a planned procedure. to do this data will be retrieved from the swedish patient register to identify all patients with a diagnosis of colorectal cancer and a stoma construction procedure during two previous calender years. to collect data on stoma function and quality of life a specific questionnaire will be sent to the cohort approximately within 2 years of the procedure.

the cohort will be identified through the national in-patient register, held by the swedish board of health and welfare, by using a combination of icd10 and nomesco codes. two calender years will be the collecytion period to reach group size allowing for statistical analysis. data from the register will be used to describe the groups (demography) and data from the prescribed drug register to calculate costs for stoma appliances after discharge. using the patient id, all patients still alive at the time, will be contacted first by a letter followed within 2-4 days by a phomecall from the study secretariate, to ask for consent and thereafter to send out the questionnaire. the questionnaire includes validated questions used before as well as validated instruments, to analyze stoma function in detail as well as quality fo life, as well as questions where answers will be used for adjustment in analyses.

Eligibility criteria:
inclusion criteria: * stoma permanently or for shorter period exclusion criteria: * not understanding swedish
investigation of tolterodine, pregabalin and a tolterodine - pregabalin combination for the treatment of overactive bladder

Conditions: Overactive Bladder

Summary: tolterodine is approved for use in the treatment of overactive bladder (oab). the study is designed to a investigate whether pregabalin may have efficacy in oab and whether the efficacy is altered when it is combined with tolterodine.


Eligibility criteria:
inclusion criteria: * women \> 18 years old * diagnosis of oab (micturition frequency \>/= 8 times per day; urinary urgency \>/= 4 times per week) exclusion criteria: * subjects with symptoms of overactive bladder for less than 6 months prior to randomization. * significant stress incontinence as determined by the investigator e.g. stress predominant mixed incontinence, positive cough provocation test. * subjects with any condition that would contraindicate the use of tolterodine or pregabalin, including: uncontrolled narrow angle glaucoma; urinary retention; myasthenia gravis; gastric retention; severe ulcerative colitis; toxic megacolon; rare hereditary problems of galactose intolerance; fructose intolerance; sucrose-isomalate insufficiency; lapp lactase deficiency; glucose-galactose malabsorption.
spinal cord stimulation research study

Conditions: Chronic Low Back and Leg Pain

Summary: the purpose of this study is to characterize subjects' response to spinal cord stimulation with postural changes.


Eligibility criteria:
inclusion criteria: * be ambulatory * be 18 years of age or older * have chronic low back pain and/or leg pain due to neuropathic causes * be implanted with the restore or restore advanced system for greater than or equal to 3 months * be implanted with percutaneous thoracic leads * have stable pain control * adjust stimulation parameters manually on a regular basis * be willing and able to complete protocol requirements * be willing and able to provide written informed consent * be male or nonpregnant female exclusion criteria: * plan to enroll in another clinical study during participation in this study, or currently enrolled in another clinical study * be morbidly obese * had pain-related surgery in the previous 12 weeks of enrollment or intend to undergo surgery during the period of the study

Keywords: subject's response changes in spinal cord stimulation during postural
oral carbohydrate in dm patients undergoing total knee arthroplasty

Conditions: Total Knee Arthroplasty

Summary: the primary purpose of this study is to investigate the effects of carbohydrate-rich drink on postoperative nausea and vomiting in diabetic patients undergoing total knee arthroplasty. the secondary purpose is to investigate the effects of carbohydrate-rich drink on quality of recovery and inflammation in diabetic patients after total knee arthroplasty.

carbohydrate-rich drink has been proved to neither delay gastric emptying nor affect gastric acidity and is therefore considered safe to use in elective surgical patients without risk factors for pulmonary aspiration. it reduced postoperative nausea and vomiting and improved sense of well-being after surgery. moreover, carbohydrate-rich drink was not found to be affected by delayed gastric emptying in patients with uncomplicated type 2 diabetes. therefore, carbohydrate drink may be safely administered 3 h before anesthesia without risk of hyperglycemia or aspiration.

Eligibility criteria:
inclusion criteria: * type 2 dm patients undergoing elective total knee arthroplasty exclusion criteria: * contraindication to regional anesthesia * patients whose operation is scheduled to start after 9:00 am * dementia or cognitive dysfunction * hba1c \> 8% * gastroesophageal reflux disease
pharmacotherapy for schizophrenic drug users - 6

Conditions: Cocaine-Related Disorders; Substance-Related Disorders; Shcizophrenia

Summary: the purpose of this study is to evaluate maintenance neuroleptics for schizophrenic patients who are cocaine abusers.


Eligibility criteria:
please contact site for information.

Keywords: anti psychotic agents