Kornimate/medical-research-clean huggingface dataset:
lavender during intrauterine insemination

Conditions: Infertility, Female; Anxiety

Summary: the researchers hope to learn if by using lavender aromatherapy during an intrauterine insemination patients have decreased anxiety and pain at the time of the procedure.

infertility patients have a high level of anxiety before and during infertility treatments due to anticipated discomfort of a procedure and anticipation of a long awaited pregnancy. aromatherapy with lavender, an essential oil, has been shown to be effective in reducing anxiety and pain in a variety of procedures such as botox injections, cesarean delivery and intrauterine device placement.

Eligibility criteria:
inclusion criteria: * women undergoing intrauterine insemination * english speaking exclusion criteria: * allergy to lavender oil or its components * currently using aromatherapy * contraindication to intrauterine insemination * contraindication to pregnancy
bone metabolism after laparoscopic gastric bypass surgery (babs)

Conditions: Evaluation of Expected Bone Loss After Bariatric Surgery; Possible Prevention of Bone Loss After Surgery by Calcium and Vitamin D Supplementation

Summary: bariatric surgery leads to rapid weight loss in female and male patients. less data are available about its impact on bone metabolism. the aim of this study is the investigation of changes in bone mineral density,bone histomorphometric changes, serum bone turnover markers and changes in body fat and muscle composition in patients after laparoscopic gastric bypass surgery.

obese female and male adult patients eligible for laparoscopic gastric bypass surgery according to the national austrian guidelines will be included in this study upon request and after patient approval. baseline data collection and quarterly follow up visits are planned to investigate the changes in bone mineral density and body composition measured by dual energy x-ray absorptiometry as well as the evaluation of serum bone turnover markers of bone formation and resorption. after surgery subjects will be randomized into two groups: daily oral calcium (500mg) and weekly vitamin d3 supplementation (16.000 iu calciferol)or no supplementation of calcium and calciferol. a sub-study (approximately 15% of study population) with transiliac bone biopsies will also be performed to investigate histomorphometric and histologic changes in bone (biopsy baseline and after 24 months). the planned duration of the study is 24 months for each subject. serum bone turnover markers will be collected every 3 months, dual energy x-ray absorptiometry measurements will be performed every 6 months.

Eligibility criteria:
inclusion criteria: * body mass index \>35 * female and male patients * age 18 - 65 years * eligible for laparoscopic gastric bypass surgery according to the austrian national guidelines exclusion criteria: * any history of malignancy except basalioma * any prior antiresorptive treatment * any prior calcium or vitamin d supplementation * any secondary disease affecting bone metabolism
microwave ablation versus liver resection for early hepatocellular carcinoma in patients with borderline liver function

Conditions: Carcinoma, Hepatocellular

Summary: we propose a randomized controlled study to compare the treatment efficacy of microwave ablation to liver resection for hepatocellular carcinoma (hcc) in patients with borderline liver function.

hepatocellular carcinoma (hcc) is a common cancer and is diagnosed at an earlier stage and with increasing frequency because of the wider implementation of screening programs. whether liver resection or local ablation should be the first-line treatment in early hcc remains a hot topic for debate. both are regarded as acceptable curative treatment for early hcc in many international guidelines. underlying liver function is the key in treatment selection. the general consensus is that liver resection should be the treatment of choice in patients with good liver function while local ablation should be considered in patients with poor liver function. there exists a group of patients with apparently good liver function that harbor significant liver cirrhosis which is not easily picked up by the current assessment or scoring systems. liver resection in this group of patients is burdened by potentially life-threatening complications and the overall survival is limited by their underlying liver cirrhosis. this is particularly important in early hcc as local ablation is another curative treatment option. in order to improve the prognosis of patients with early hcc, it is important to identify (1) patients with liver dysfunction to the extend that the risk of liver resection will outweigh the survival benefit it provides; (2) the best ablative method for hcc. the investigators propose to carry out a prospective randomized controlled study to compare the treatment outcome of microwave ablation with liver resection in patients with borderline liver function whose hcc that are amendable to both liver resection and microwave ablation.

Eligibility criteria:
inclusion criteria: * age \>18 years * hcc amendable for both mwa and liver resection * liver function of albi grade 2 * tumour size \</= 5cm * absence of extrahepatic metastasis * absence of radiology evidence of major vascular or bile duct invasion exclusion criteria: * informed consent not available * patients with albi 3, child-pugh b or above * multifocal tumour * presence of portal vein or hepatic artery thrombosis * anticipation of concomitant procedures * emergency hepatectomy * ruptured hcc * patients with chronic renal failure * pregnant female patients

Keywords: hepatocellular carcinoma hepatectomy microwave ablation local ablation
actinic keratosis study

Conditions: Actinic Keratosis

Summary: the main purpose of this study is to determine the effectiveness of a new combination therapy for actinic keratosis. this study investigates a new indication for an fda-approved topical medication, calcipotriol, for treatment of actinic keratosis, including how well it works and how safe it is when used in combination with the standard of care medication (5-fluorouracil) for the skin condition.


Eligibility criteria:
inclusion criteria: * age of at least 50 years * presence of four to fifteen clinically typical, visible, and discrete actinic keratoses in 25 cm2 on any of the four anatomical sites: scalp, face, right upper extremity and left upper extremity * ability and willingness of the patient to participate in the study (informed consent is obtained) exclusion criteria: * treatment area is within 5 cm of an incompletely healed wound or a suspected basal-cell or squamous-cell carcinoma * treatment area contained hypertrophic and hyperkeratotic lesions, cutaneous horns, or lesions that had not responded to repeated cryotherapy * recent (within a month) use of medications that could interfere with evaluation of the treatment area (e.g., topical medications, artificial tanners, immunosuppressive medications, immunomodulating agents, cytotoxic drugs, ultraviolet b phototherapy, other therapies for actinic keratoses, or oral retinoids) * premenopausal women (to avoid any risk of pregnancy) * history of hypercalcemia or clinical evidence of vitamin d toxicity
cyp2d6 genotyping by amplichiptm cyp450 for tamoxifen-treated breast cancer patients

Conditions: Breast Cancer

Summary: the aim of the study is to examine whether tamoxifen-treated israeli breast cancer patients who are cyp2d6 poor metabolizers (cyp2d6\*4/\*4 genotype) are at higher cancer relapse risk during 2.5-5-year follow-up period from initial diagnosis and primary treatment.

tamoxifen, the first-line drug for preventing breast cancer relapse, is typically prescribed for a 5-year follow-up period after diagnosis and primary treatment of estrogen receptor-positive breast cancer. recent studies show that tamoxifen is only a pro-drug, while its major active metabolite, endoxifen, is formed in vitro by the liver enzyme cyp2d6. preliminary observations from the us and italy have suggested that tamoxifen is less efficacious for cancer relapse prevention in patients with deficient cyp2d6 activities. the fda is currently reviewing the new data and is likely to modify the tamoxifen label accordingly. it was suggested that an aromatase inhibitor drug such as letrozole might be more beneficial for these patients. the proposed study would retrospectively test cyp2d6 genotypes in 200 - 300 estrogen receptor (er) positive breast cancer patients who are treated with tamoxifen post-operatively. blood collected with informed consent would be used for examining the patients cyp2d6 genotype, and identifying those who are cyp2d6 poor metabolizers (cyp2d6\*4/\*4 genotype), and for measurement of endoxifen blood level in those women who are on the drug. amplichiptm cyp450 is a microarray chip which contains millions of tiny dna molecules, providing comprehensive coverage of gene variations that play a role in the metabolism of approximately 25% of all prescription drugs. the amplichiptm cyp450 test is intended to be an aid for physicians in individualizing treatment doses for patients receiving therapeutics metabolized through these enzymes. the clinical data collected would examine if these individuals, as well as those treated with cyp2d6 inhibiting drugs such as paroxetine and fluoxetine, have higher cancer relapse rates. the study, combined with similar findings from other countries, and possibly integrated later on with an international network study, would be imperative for modifying treatment recommendations for breast cancer therapy. specifically, if the us and italian findings are confirmed, it might be advisable to switch the 5-year follow-up treatment for breast cancer patients with er positive primary tumors who are cyp2d6 poor metabolizers from tamoxifen to an aromatase inhibitor drug such as letrozole.

Eligibility criteria:
inclusion criteria: * female * age \> 18 * treated with tamoxifen following diagnosis of breast cancer exclusion criteria: * none

Keywords: receptor positive breast cancer tamoxifen treatment cyp2d6 status relapse
non-invasive mapping using ultra-high frequency electrocardiography

Conditions: Left Bundle-Branch Block; Right Bundle-Branch Block; Non-Specific Intraventricular Conduction Defect

Summary: cardiac electrical mapping is an important tool that allows doctors to study the electrical activity of the heart in detail. electrical mapping systems used in clinical practice are time consuming, invasive and very costly. ultra-high frequency electrocardiography is a novel non-invasive cardiac mapping system. ultra-high frequency electrocardiography (uhf-ecg) can be performed in 10-15 minutes without any risk or discomfort to patients. the aim of this study is to refine this mapping system, verify it against invasive mapping and develop software to bring this novel system into routine clinical use including predicting which patients will respond to cardiac resynchronisation therapy.

this is a single centre laboratory study aiming to utilise ultra-high frequency electrocardiography to construct cardiac electrical activation maps. all participants will attend for an uhf-ecg. this involves placing standard electrocardiography electrodes (up to 48) followed by electrocardiography recording using the uhf-ecg machine for 10-15 minutes. participants undergoing a clinically indicated vt ablation procedure will their uhf-ecg done before the procedure at a separate time. the ablation procedure itself will proceed as standard with no alternation whatsoever in study participants and no invasive measurements will be undertaken during the procedure. after the procedure is complete the 3d electrical maps collected to guide vt ablation will be analyzed and used for the study. the invasive maps will be compared with the non-invasive maps obtained using uhf-egc.

Eligibility criteria:
inclusion criteria: * adults (age \> 18 years) * able to give consent * some patients will be recruited from those listed for a clinically indicated vt ablation * patient subgroups as follows; 60 participants with lbbb undergoing a clinically indicated vt ablation , 20 participants with normal 12 lead ecg and normal left ventricular function assessed using standard echocardiography, 20 participants with right bundle branch block morphology on 12 lead ecg, 40 participants with non-specific conduction delay on 12 lead ecg, 60 participants with left bundle branch block morphology on 12 lead ecg and 20 participants who developed left bundle branch block morphology on 12 lead ecg after undergoing aortic valve replacement exclusion criteria: * unable to give consent * children (age \< 18 years)

Keywords: ultra-high frequency electrocardiography left bundle branch block cardiac resynchronization therapy his bundle pacing
rct: fentanyl plus ketamine versus fentanyl alone for acute burn pain

Conditions: Acute Pain; Wound Care; Posttraumatic Stress Disorder

Summary: the ketamine for acute pain in burns study is a randomized, double-blind, parallel group trial (rct) with active control (usual care) contrasting the efficacy and safety of "ketamine plus opiate-based usual care" (o+k) with the safety and efficacy of the "current standard of care". the current standard of care is an opiate medication alone, fentanyl (usual care-opiate (uc-o), dose/timing as per burn center protocol).

department of defense (dod) and the u.s. army medical research and materiel command (usamrmc) are funding this rct for the following reasons: primary aims: 1. to evaluate the safety and efficacy of fentanyl (usual care) + placebo versus fentanyl + ketamine (low-dose, sub-anesthetic, slow-infusion) during twice daily burn wound care across a 7-day study period and 30 day outcome period. 2. to evaluate the opiate sparing effect of fentanyl (usual care) + placebo versus fentanyl + ketamine (low-dose, sub-anesthetic, slow-infusion) during the 7-day study period and 30 day outcome period. and secondary aims: 1. to determine the short and long term effect of the ketamine augmentation condition versus the usual care condition on symptoms and syndromes of posttraumatic stress disorder and of depression, 2. to evaluate several established and hypothesized moderators of the relationship between the ketamine augmentation condition versus the usual care condition on: 1) pain severity reported during wound care, 2) opiate use during wound care, 3) posttraumatic stress and 4) depression.

Eligibility criteria:
inclusion criteria: * total body surface area (tbsa) greater than or equal to 2%; less than or equal to 40% tbsa * english speaking * pain in emergency room during initial wound evaluation (on admission) greater than 5 /10 * estimated length of stay greater than or equal to 5 days exclusion criteria: * requiring endotracheal intubation and sedation, * severe hearing impairment, * cognitive impairment status - mini-mental state examination (mmse) \</=20, * diminished capacity unable to provide informed consent; * past medical history (pmh): insensate (eg. spinal cord injury, peripheral neuropathy) * safety: contraindication (e.g., potential drug interactions or medical comorbidities)

Keywords: opioid ketamine
neural biomarkers of electroconvulsive therapy response

Conditions: Electroconvulsive Therapy Treated Patients

Summary: in the proposed study, the investigators will utilize resting-state functional mri (fmri) and structural mri-based electrical field modeling to study the effect of electroconvulsive therapy on human neural circuitry. our study will recruit patients who are beginning treatment with bilateral electroconvulsive therapy (n=75). our design will be longitudinal where patients will be followed up until their 8th week electroconvulsive therapy clinically. the primary measure of interest will be the slope of clinical change estimated with mixed effect modeling (see approach). secondary measures will be the cognitive performance change between baseline and the 8th week electroconvulsive therapy time point.


Eligibility criteria:
inclusion criteria: 1. current positive symptoms rated ≥4 (moderate) on one or more of these bprs 53 items: hallucinatory behavior, unusual thought content, suspiciousness, conceptual disorganization; 2. has failed at least one trial of treatment with antipsychotic drug, lasting 6 weeks in duration, 3. competent and willing to sign informed consent; 4. for women, negative pregnancy test and agreement to use a medically accepted birth control method; and 5. diagnostic and statistical manual (dsm)-iv diagnosis of schizophrenia, schizoaffective or schizophreniform disorder. exclusion criteria: 1. serious neurological or endocrine disorder; 2. any medical condition which requires treatment with a medication with psychotropic effects; 3. significant risk of suicidal or homicidal behavior; 4. cognitive (mmse ≤ 23) or language limitations that would preclude subjects providing informed consent; 5. contraindications to treatment with electroconvulsive therapy; 6. contraindications to magnetic resonance imaging (e.g. pacemaker)
glucose and lipid metabolism in adolescents

Conditions: Exercise; Obesity; Insulin Sensitivity

Summary: a 12 wk aerobic exercise program will reduce visceral, hepatic and intramyocellular fat accumulation and improve insulin sensitivity and glucose metabolism in obese sedentary hispanic adolescents.

lean and obese post pubertal adolescents perform an aerobic exercise program 30 minx4/week at a heart rate corresponding to at least 70% of that obtained at vo2 peak. the exercise program is preceded and followed by a 7 d diet delivered by the metabolic research kitchen (identical on both study occasions); metabolic studies (identical on both study occasions) including 24h calorimetry, measurements of glucose and lipid metabolism and insulin sensitivity and secretion using compounds labelled with stable i.e. non radioactive isotopes and gas chromatography-mass spectrometry.fat mass and lean body mass are measured by dxa and visceral/subcutaneous, hepatic and intramyocellular fat by mri/mrs. since we want to specifically determine the effects of exercise, there is no intent of weight loss. the subjects are weighed twice a week to assure weight stability.

Eligibility criteria:
inclusion criteria: * healthy * no medication * sedentary * no first degree relative with diabetes, * hispanic * bmi \>30 or \<25 kg/m2. exclusion criteria: * any medication including birth control pills * performing more than \>45 min of moderate to light physical activity/week * chronic illness

Keywords: exercise in obesity
preliminary evaluation of the clinical safety and effectiveness of the bionic nerve scaffold

Conditions: Peripheral Nerve Injuries

Summary: the objective of the study is to preliminarily evaluate the clinical safety and effectiveness of the bionic nerve scaffold with longitudinally oriented microchannels. 10 patients with peripheral sensory nerve defects will be involved and divided into 2 groups: the experimental group is treated with the nerve scaffold, and the control group without that. then follow the cases up and draw conclusion according to the results of observation and examination.

the objective of the study is to preliminarily evaluate the clinical safety and effectiveness of the bionic nerve scaffold with longitudinally oriented microchannels developed in the department of orthopaedics in xijing hospital in repairing the peripheral nerve defect. according to the inclusion and exclusion criteria, 10 patients with peripheral sensory nerve defects of 1 to 3 cm in size will be involved. divided them into 2 groups. the experimental group of 5 cases will be treated with the nerve scaffold, and the control group without that. then follow the cases up at about 2 weeks, 3 months and 6 months after surgery. observe the condition of the healing of the local wound and the whole body of the 10 patients. examine the blood routine and biochemical indexes of the experimental group. sensory recovery of injured nerves will be tested at about 3 months and 6 months after surgery. record the results in the case report forms. analyze the data statistically and draw conclusion.

Eligibility criteria:
inclusion criteria: * age from 18-50 yeas old, male or female, course of disease is within one year; * good heart, liver and kidney function; * with peripheral sensory nerve defects of 1-3 cm in size, and willing to repair it with the nerve scaffold; * no significant damage existing in the skin and soft tissue in the operative region * have signed the informed consent form * good adherence and willing to return for follow-up visits as required. exclusion criteria: * with acute or severe infection * suffering from serious primary diseases of heart, brain, liver and kidney, blood system, endocrine system and so on, and can not tolerate surgery * with histories of peripheral vascular disease, immunological disorder chronic alcoholism, and drug abuse and so on * with family history of genetic * allergic to collagen and chitosan * pregnancy and lactating women * serious damage existing in the skin and soft tissue in the operative region * bad adherence and can not return for follow-up visits on time as required

Keywords: scaffold peripheral nerve injures repair safety effectiveness