Kornimate/medical-research-clean huggingface dataset:
retrospective cohort study of the efficacy of axona® (medium chain triglycerides) in patients with alzheimer's disease

Conditions: Alzheimer's Disease

Summary: this evaluation of the efficacy and safety of axona will be a chart review carried out at 16 practices in which axona has been prescribed for the treatment of patients with mild-to-moderate ad. efficacy of axona will be assessed by comparison of patient status before and after initiation of treatment.

the primary objective is to assess the efficacy of axona (medium chain triglycerides \[mcts\]) when used alone or in combination with other agents in patients with mild-to-moderate alzheimer's disease (ad) in routine clinical practice.

Eligibility criteria:
patient inclusion criteria: * male or female outpatients aged ≥ 50 years with a diagnosis of probable ad of mild-to-moderate severity * mmse score between 14 and 24 inclusive at the initiation of axona treatment (if available) * has received axona for a duration of ≥ 6 months caregiver inclusion criteria (if applicable): * must be at least 21 years of age, has been the primary caregiver since prior to the initiation of axona, provides at least 4 hours of supervision or direct assistance per day for the patient and is able to perform assessments. patient exclusion criteria: * mmse score \< 14 at the time when axona treatment was initiated * presence of co-morbid disease known to adversely impact cognitive function (e.g., parkinson's disease, history of cerebral infarcts, dementia with lewy bodies) * vascular dementia

Keywords: alzheimer's disease retrospective axona
topiramate to aid smoking cessation in alcohol dependent men

Conditions: Nicotine Dependence; Alcohol Dependence

Summary: the purpose of this study is to determine whether topiramate is effective as an aid to smoking cessation for recovering alcohol dependent men.

this study is a 12-week, double-blind, placebo-controlled trial to test the efficacy of topiramate versus placebo as an aid to smoking cessation for recovering alcohol dependent men. another aim of the study is to explore whether or not topiramate reduces relapse to alcohol use in patients with comorbid alcohol and nicotine dependence. all participants will receive a standardized psychosocial intervention in combination with the medication (or placebo). following completion of the treatment phase of the study, participants will enter a 24-week follow-up period during which the longer-term outcome of the intervention will be assessed.

Eligibility criteria:
inclusion criteria: subjects will be included if they: * are 18-70 years of age, inclusive; * are male outpatients with a diagnosis of dsm-iv-tr nicotine dependence and alcohol dependence in early full remission (1-36 months abstinence); * are current tobacco smokers who smoke an average of 10 or more cigarettes per day in the two months prior to the screening visit; * are motivated to try to quit smoking and maintain abstinence from alcohol and other illicit drugs; exclusion criteria: subjects will be excluded if they: * have any clinically significant laboratory evidence of hematologic, hepatic, cardiovascular, renal, pulmonary, or thyroid disease; * have a current significant neurologic, hepatic, renal, gastrointestinal, pulmonary, metabolic, cardiovascular, infectious, or endocrine disease; * have a history of known hypersensitivity to topiramate; * in the investigator's judgment, pose a current suicidal or homicidal risk; * have taken any investigational drug within 30 days of baseline; and * have a current seizure disorder or a history of severe alcohol withdrawal (alcohol withdrawal seizures, hallucinations / illusions, delirium tremens).

Keywords: tobacco use disorders alcoholism
ctdna in patients with thyroid nodules

Conditions: Thyroid Cancer; Thyroid Nodules; Thyroid Adenoma; Thyroiditis

Summary: when the dna inside of human cells undergoes certain alterations (mutations), the cells may develop into a cancer. the cancer cells may shed this dna into the blood stream. this circulating tumor dna (ctdna) can be detected by very sensitive, specialized laboratory tests. measurement of ctdna has been shown to be useful for following patients with known cancer. the purpose of this study is to examine blood specimens for the presence of ctdna in individuals without known cancer who are scheduled to undergo a fine needle aspiration biopsy of the thyroid gland because of one or more thyroid nodules in order to see if the ctdna test can detect a cancer at a very early stage. the results of this study should help define the role of ctdna in the detection of early stage thyroid cancer and to define how sensitive it is (i.e. how well it picks up cancer when it is present) and how specific it is (i.e. how often is ctdna found in patients with benign thyroid nodules).

after the participants with thyroid nodules or other abnormalities have undergone the informed consent process, they will have 30 milliliters (approximately two tablespoons) of blood drawn. this will be done prior to the performance of the fine needle aspiration biopsy of the thyroid. if the patient has indicated a desire to receive the results of their test, they will receive a written description, as will their physician. the patients will be contacted yearly for up to 5 years by the study staff to learn whether they have been found to have a diagnosis of thyroid or other cancer.

Eligibility criteria:
inclusion criteria: * 18 years of age or older; * presence of one or more thyroid nodules who are going to have a fine needle aspiration biopsy performed as part of their normal care. exclusion criteria: * prior history of cancer excluding basal cell carcinoma of the skin.

Keywords: thyroid cancer thyroid nodules thyroid neoplasia thyroiditis
prevention of acute cholecystitis with etgbd

Conditions: Biliary Obstruction; Acute Cholecystitis

Summary: the goal of this clinical trial is to learn about efficacy of the etgbd parallel insertion with fully covered self-expandable metal stent for preventing acute cholecystitis in patients with low cystic duct insertion. in this study, we hypothesized that endoscopic transpapillary gallbladder drainage (etgbd) with parallel insertion of a fully covered self-expanding metal stent(fcsems) through an endoscopic biliary drainage tunnel is superior in preventing complications such as cholecystitis when the gallbladder ducts confluence within the distal third of the common bile duct. and we aimed to confirm its efficacy by comparing the frequency, severity, and rate of invasive additional procedures due to cholecystitis complications to provide evidence of clinical utility.


Eligibility criteria:
inclusion criteria: 1. adults 19 years of age or older 2. patients requiring endoscopic retrograde cholangiography and drainage for therapeutic purposes. 3. patients with imaging (ct, cholangiogram) confirmed confluence of the cystic duct with the distal third of the common bile duct. 4. patients who have voluntary informed consent to participate in the study. exclusion criteria: * patients who have undergone percutaneous/surgical bile duct or gallbladder drainage prior to study enrollment. * patients with anatomic deformity of the upper gastrointestinal tract after gastric or hepatobiliary surgery * patients with concomitant gastric/duodenal obstruction * patients with confirmed or suspected cystic duct obstruction on imaging studies * patients with acute cholecystitis, acute pancreatitis * patients who underwent cholecystectomy * patients with a life expectancy of less than 3 months * patients who are otherwise unable to undergo endoscopic retrograde cholangiopancreatography

Keywords: malignant biliary obstruction fully covered self expandable metal stent endoscopic transpapillary gallbladder drainage preventive effect acute cholecystitis
laterality discrimination in patients with non-specific chronic neck pain

Conditions: Neck Pain

Summary: chronic neck pain is one of the most common causes of pain, affecting 15% of the adult population, and the fourth leading cause of disability. the recognition of laterality is the ability to recognize a part of the body that belongs to the left or right which is used as a tool to create a normal process of motor planning.

the most consistent data come from the investigation of the primary motor cortex, in which the cortical representations of the altered body part are affected when there is chronic pain. occasionally, the primary motor cortex is smaller on the affected side than on the contralateral side. recognition of the body schema is altered in the presence of painful disorders. the most common way of assessing the body schema is by motor imagery through the laterality discrimination of the left and right.

Eligibility criteria:
inclusion criteria: * the inclusion criteria were as follows: a) men and women aged between 18- and 65-years b) medical diagnosis of non-specific chronic neck pain with more than 6 months of evolution of neck pain. exclusion criteria: * exclusion criteria included the following: a) patients with rheumatic diseases, cervical hernia, cervical whiplash syndrome, neck surgeries or history of arthrodesis, b) systemic diseases, c) vision, hearing or vestibular problems, d) severe trauma or traffic accident which has had an impact on the cervical area.

Keywords: laterality task, neck pain
tolerability and satisfaction with evie

Conditions: Infertility

Summary: the purpose of this study is to determine patient satisfaction and tolerability of the evie® slow-release insemination device for us population. additionally, to assess cramping with the device and to determine pregnancy rates using the slow insemination device compared to standard iui.


Eligibility criteria:
the inclusion criteria: * infertile women age ≤39 undergoing first iui cycle for relatively unexplained infertility * irb approval and informed consent signed exclusion criteria: * women \<18 or ≥40 years old * women with abnormalities of the uterine cavity * women with tubal occlusion * history of documented pelvic adhesions or endometriosis * uncorrected ovulatory dysfunction * uncorrected thyroid function * amh \<1 ng/ml * \<5 million total motile sperm expected for insemination in prior analyses or on the day of sperm preparation for insemination

Keywords: infertility intrauterine insemination slow-release insemination evie
exercise training as a novel primary therapy for men with localised prostate cancer

Conditions: Prostate Cancer

Summary: study design: the study is a two arm randomised controlled trial (randomisation ratio 1:1) comparing an aerobic exercise training intervention to usual care plus exercise advice. the primary outcome is the feasibility of the intervention as novel primary therapy in men with localised prostate cancer.


Eligibility criteria:
inclusion criteria: in accordance with nice active surveillance guidelines, men: * who have been evaluated using a combination of clinical, bio-chemical, imaging and/or biopsy, within the last 12 months * with histologically confirmed low or intermediate risk prostate cancer, gleason score ≤7 (3+4, not 4+3) * with up to t2a clinical stage tumours * with pre-treatment psa ≤20 ng/ml * who are willing to participate in optimal active surveillance and provide written informed consent * with life expectancy of ≥10 years exclusion criteria: men: * with unstable angina * with uncontrolled hypertension * with recent myocardial infarction (within the past 6 months) * with pacemakers * already undertaking regular physical activity (greater than 90 minutes of moderate intensity exercise, per week) will be excluded * with any other physical or mental limitation preventing participation in trial assessments * participating in other clinical trials which might bias the evaluation of the primary objectives of the present study
vdr snps & 25ohd correlated with dyslipidemia

Conditions: Dyslipidemias; Single Nucleotide Polymorphism

Summary: the project was aimed to explore the associations of single nucleotide polymorphisms (snps) of vitamin d receptor gene with specific circulating lipids in adult chinese. the circulating 25-hydroxyvitamin d concentration was also tested to explore its interactions with snps in the associations.


Eligibility criteria:
inclusion criteria: * 1) ≥ 20 years old han chinese; * 2) living in shenzhen for \> 2 years; * 3) free of liver diseases, renal diseases, and any cancers in the past 6 months; and * 4) not in pregnancy for women. exclusion criteria: * 1) had severe organic diseases, * 2) had acute infection symptoms, allergic diseases, and malignant tumors, * 3) had a family history of genetic diseases, * 4) took vd supplements in the past 6 months, * 5) took medicines to control lipid levels within 12 hours, or * 6) took diuretics, did strenuous exercise, or overate within 24 hours before the test.

Keywords: gene polymorphism vitamin d receptor vitamin d lipid dyslipidemia
nutritional safety and metabolic benefits of oncometabolic surgery for obese gastric cancer patients

Conditions: Oncology; Metabolic Disease; Gastric Cancer

Summary: the metabolic effect of oncometabolic surgery (long limb roux-en y reconstruction) for early gastric cancer patients has been revealed in a few pilot studies. however, the nutritional safety has not been dealt with in previous literatures. this is a prospective pilot study for evaluating the nutritional safety and metabolic benefits of oncometabolic surgery for obese early gastric cancer patients.

we performed long limb uncut roux-en y gastrojejunostomy (urygj) in 20 patients with clinical t1n0 stage and preoperative body mass index (bmi) ≥ 32.5 kg/m2 or ≥ 27.5 kg/m2 with co-morbidities between september 2015 and july 2016. the primary endpoint was the incidence of micronutrients' deficiency (iron, folate, vitamin b12) at postoperative 1 year and secondary endpoints were anemia incidence, bmi change and remission rates of co-morbidities.

Eligibility criteria:
inclusion criteria: * lesion located on distal or mid stomach lesion confined to submucosa (ct1b) : early gastric cancer no evidence of metastatic enlarged lymph nodes preoperative body mass index (bmi) ≥ 32.5 kg/m2 or ≥ 27.5 kg/m2 with co-morbidities exclusion criteria: * being unable to understand the risks, benefits and compliance requirements of this trial non- korean speaker american society of anesthesiology (asa) class iv or higher other malignancy within 5 years.

Keywords: oncometabolic surgery long limb uncut roux-en-y gastrojejunostomy obesity diabetes early gastric cancer
incisionless treatment for patients with inadequate weight loss following roux-en-y gastric bypass

Conditions: Obesity

Summary: it is estimated that up to 20% of patients who have roux-en-y gastric bypass (rygb) surgery will not meet their weight loss goal, or may even regain some of the weight they initially lost. one possible explanation is that the opening between the stomach pouch and the intestine becomes stretched. if this opening becomes too wide, food may be able to pass from the stomach to the intestine too quickly - causing patients to feel less full after eating. for some patients, doctors may recommend additional invasive surgery to tighten the opening between the stomach pouch and the small intestine. although this may help patients resume their weight loss, the risk of complications during a second surgical procedure is significantly higher than the risk during the original gastric bypass. the purpose of this study is to evaluate an incisionless procedure for patients who have either had inadequate weight loss or have regained weight following gastric bypass. the procedure is designed to tighten the opening between the stomach pouch and the small intestine, which may slow down the passage of food to help patients feel full longer after eating.


Eligibility criteria:
inclusion criteria: * 6 months post primary rygb with inadequate weight loss or weight regain * bmi \>30 and ≤ 50 * dilated gastrojejunal anastomosis * successfully completes screening process * signed consent exclusion criteria: * recently quit smoking or plan to quit within the next year * pregnant or planning to become pregnant over the course of the next 9 months * mallampati score of 4 * serious systemic disease or active disease of the gastrointestinal tract * gastric pouch abnormalities * significant movement limitations * use of weight-promoting or weight-reduction drugs during study period * severe eating disorders * uncontrolled depression or psychoses * ongoing severe complication resulting from initial rygb or other condition that in the investigators' assessment would make the patient an unsuitable candidate for the study procedure * history of significant cardiovascular, cerebrovascular or pulmonary disease * not a candidate for conscious or general sedation * anticoagulant therapies * active substance abuse * life expectancy \< 1 year * enrolled in another investigational drug or device trial that has not completed the primary endpoint or that clinically interferes with this trial's study endpoints

Keywords: weight loss transoral suturing dilated gastrojejunostomy inadequate weight loss following primary rygb
clinical trial with clobetasol and dexamethasone for topical treatment of oral lesions of chronic graft-versus-host disease

Conditions: Graft vs Host Disease; Oral Manifestations

Summary: the purpose of this study is to perform a randomized, double-blind, clinical trial comparing the topical treatment with clobetasol or dexamethasone for symptomatic oral lesions of chronic graft-versus-host disease.

all patients with symptomatic oral lesions of cgvhd were included in the study. exclusion criteria were patients with 12 years or less of age, history of allergy to any of the studied medications and patients already under other topical treatment for oral lesions of cgvhd. patients were randomly assigned between two study groups: one group rinsed with a solution of clobetasol propionate 0.05% associated to nystatin 100,000 ui/ml; and another group rinsed with a solution of dexamethasone 0.1 mg/ml associated to nystatin 100,000 ui/ml. patients were instructed to use the solution 3 times a day, during 1 minute, for 28 days. clinical exams were performed at baseline and after 28 days. patients were evaluated by an oral medicine expert, previously calibrated for evaluation of oral cgvhd lesions. oral lesions of cgvhd were diagnosed according to nih 2005 criteria, and graded according to the modified oral mucositis rating scale. evaluation of the symptoms of the oral mucosa and of xerostomia were performed through visual analogue scale. samples for fungal culture were obtained before and after the topical treatment. results were submitted to a descriptive analysis. chi-square was used for the comparison of categorical variables. mann-whitney and wilcoxon tests were used for the comparison of measurable data inter and intra-groups, respectively. significance level was set at 5%.

Eligibility criteria:
inclusion criteria: * patients with symptomatic oral lesions of chronic graft-versus-host disease exclusion criteria: * patients with less than 12 years of age * patients physically of mentally disabled * history of allergy to any of the medications under study * patients already under topical treatment for oral lesions of chronic gvhd

Keywords: bone marrow transplantation graft vs host disease oral manifestations
efficacy, safety and pharmacokinetics of topical timolol in infants with infantile hemangioma (ih)

Conditions: Infantile Hemangioma

Summary: the purpose of this study is to assess the safety and efficacy of timolol 0.25% and 0.5% doses.

primary: describe the efficacy of 0.25% and 0.5% topical timolol maleate gel-forming solution (gfs) as assessed through infantile hemangioma (ih) changes in volume. secondary: describe the safety of topical timolol maleate gfs for treatment of ih.

Eligibility criteria:
inclusion criteria 1. documented informed consent from legal guardian 2. 0-84 days postnatal age at time of first study dose or when enrolled into the non-intervention cohort. 3. clinical diagnosis of superficial cutaneous or mucosal infantile hemangioma (must include all of the following): 1. superficial lesion in the dermis 2. thin \<2 mm in thickness 3. small \>=5 cm at its longest dimension and \<=10cm2 4. involves skin or keratinized mucosa exclusion criteria 1. history of previous treatment with any pharmacologic or laser therapy for ih 2. ongoing therapy with an oral beta blocker or oral corticosteroid (e.g., cardiac arrhythmia, adrenal insufficiency, upper airway obstruction, tetralogy of fallot (tof), hypertension, reactive airways disease) 3. ih that requires systemic therapy (defined by dynamic complication scale \>3) 4. ih of the non-keratinized mucosa 5. infants with more than one hemangioma that requires therapy 6. hemodynamically significant cardiovascular disease, as determined by the investigator 7. known allergy to beta blockers or vehicle 8. heart rate \<100 beats per minute at screening visit 9. known prenatal or postnatal diagnosis of 2nd/3rd degree atrioventricular block 10. history of reactive airways disease (rad) 11. any condition which would make the participant, in the opinion of the investigator unsuitable for the study.

Keywords: hemangioma infantile hemangioma pharmacokinetics