Kornimate/medical-research-clean huggingface dataset:
using bite counter for weight loss: a one-month usability trial to test the effectiveness of using the bite counter

Conditions: Obesity

Summary: this is a 1-month study that will examine the use of podcasting and a wearable wrist-worn device to track calorie intake and promote weight loss. a podcast is a digital audio file that can be listened to on portable media players, like ipods, and personal computers. this study will run from july 14, 2015 to august 11, 2015. in this study, you will receive weight loss information delivered via twice weekly podcasts. you will also track each meal you eat by wearing a provided watch-like device.

this study will last approximately 1 month (about 4 weeks). participants will need to attend one 1.5-hour orientation meeting, baseline assessment, and training meeting, and then weekly 1-hour meetings for four weeks (5 meetings total). participants will listen to 2 podcasts per week and will be encouraged to monitor exercise and body weight and track each meal using the provided wearable, wrist worn device. each of the podcasts will take about 15 - 20 minutes to listen to and so participants should expect to spend 30 - 40 minutes each week listening to podcasts and up to 3 hours completing other study-related activities each week-including attending the weekly meetings-for a total of about 4 hours per week.

Eligibility criteria:
inclusion criteria: * 18-65 years of age * bmi between 25- 49.9 kg/m2 * live in columbia, south carolina area * be able to attend all assessment visits * have access to the internet, a computer, and a smartphone (iphone, android, etc.) * have md consent for participation if currently on blood pressure medications, have issues with dizziness, or have bone or joint issues * be free of an eating disorder as screened by the eating disorder screen for primary care. (if a participant has an eating disorder, they will be referred to their family physician) * no current participation in a weight loss program or taking weight loss medications (although participants may be trying to lose weight on their own) * able to prepare all their own meals (i.e. not living on-campus) exclusion criteria: * major health or psychiatric diseases, drug or alcohol dependency, thyroid conditions, or pregnancy * pregnant (or have been pregnant in the last 6 months), anticipating on becoming pregnant in the next 7 months, or currently breastfeeding o women who are pregnant should not be pursuing weight loss and should be under the direct care of a physician. therefore women who are pregnant or who are anticipating they might be pregnant should not participate in this study. if a woman becomes pregnant during the study, she will be advised to consult her care provider and will be dropped from the weight loss study.
exercise interventions for breast cancer patients undergoing neoadjuvant chemotherapy

Conditions: Breast Cancer

Summary: the benefit-study is a randomized controlled 3-arm intervention trial investigating the currently discussed hypothesis that exercise concomitant to chemotherapy (ctx) may have a beneficial effect on cancer prognosis by boosting the anti-tumoral effect of the cytostatics or by enhancing therapy compliance. this hypothesis is based on pre-clinical and exploratory clinical trials. breast cancer patients scheduled for neoadjuvant ctx will be randomized to either a resistance training or an aerobic training concomitant to the neoadjuvant ctx, or a waiting list control group that will get no exercise intervention during neoadjuvant ctx (i.e. usual care) but will exercise after breast surgery. the primary study endpoint is the tumor size. further, the effects of resistance and aerobic exercise on the clinical-pathologic stage (cps-eg) score, the pathological complete response (pcr), tolerability and compliance to ctx, physical fitness, patient reported outcomes such as fatigue, sleep problems, quality of life, depressive symptoms, anxiety and pain, as well as cognitive function, and selected biomarkers will be investigated. a confirmation of the study hypothesis would be a strong argument for patients to engage in exercise as early as during neoadjuvant ctx. the trial will also provide evidence-based guidance for patients regarding type and timing of training.


Eligibility criteria:
inclusion criteria: * women ≥ 18 years of age * unilateral or bilateral primary carcinoma of the breast, confirmed histologically by core biopsy * scheduled for neoadjuvant ctx (but not yet started) * confirmed hormone receptor and her2 status * sufficient german language skills * willing to train at the exercise facilities twice per week exclusion criteria: * any physical or mental conditions that would hamper the adherence to the training programs or the completion of the study procedures * engaging in systematic intense exercise training (at least 1h twice per week)

Keywords: exercise resistance training aerobic training breast cancer neoadjuvant chemotherapy fatigue quality of life tumor response
anal fistula treatment outcome - collagen plug versus advancement flap surgery

Conditions: Perianal Fistula

Summary: the purpose of this study is to determine whether the outcome of anal fistula repair with a collagen plug is comparable to that of repair by a mucosal advancement flap.

perianal fistula can occur as a complication to a perianal abscess. a perianal fistula is associated with significant morbidity and reduced quality of life. anal fistulas seldom heal spontaneously and may require surgical intervention. the main purpose of the operation will be to close the fistula and preserve anal continence. the traditional surgical fistula closing techniques often show disappointing results. today, a collagen plug for fistula treatment is commercially available. the mounting of this plug is technically easy and less invasive than the traditional closure of the fistula by making a lid of anal mucosa (advancement flap). the purpose of this study is to determine whether the outcome of anal fistula repair with a collagen plug is comparable to that of repair by a mucosal advancement flap, with regard to healing of fistula, anal continence and pain. plug treatment has so far shown promising results, but prospective, randomised controlled trials are needed.

Eligibility criteria:
inclusion criteria: * patients with fistula involving \> 1/3 of the external anal sphincter * single, continuous fistula tract at time of inclusion (implies pre-treatment with seton) * patients with previous fistula surgery can be included (max. 1 lambeau or 1 plug) * all patients included must be able to fill in an informed, written consent and to understand its implications and contents and to participate in the follow-up exclusion criteria: * fistula tract shorter than 2 cm * complex fistula tract system (branching of the fistula tract) * age \< 18 years * pregnancy * hiv-positivity * fistula caused by malignancy * tuberculosis * hidrosadenitis suppurativa * pilonidal sinus disease * no internal fistula opening found * unable/contra indications to go through mri scanning * crohn´s disease * ulcerative proctitis
study of sacituzumab govitecan combinations in first-line treatment of participants with advanced or metastatic non-small-cell lung cancer (nsclc)

Conditions: Non-small Cell Lung Cancer

Summary: the goal of this clinical study is to learn more about the study drug, sacituzumab govitecan-hziy (sg), and its dosing in combination with pembrolizumab or pembrolizumab and a platinum agent (carboplatin or cisplatin), in participants with advanced or metastatic (cancer that has spread) non-small-cell lung cancer (nsclc).


Eligibility criteria:
key inclusion criteria: * individuals with pathologically documented evidence of stage iv non-small cell lung cancer (nsclc) disease at the time of enrollment * measurable disease by computed tomography (ct) or magnetic resonance imaging (mri) as per recist version 1.1 criteria by investigator * no prior systemic treatment for metastatic nsclc * eastern cooperative oncology group (ecog) performance status score of 0 or 1 * adequate hematologic counts * adequate hepatic function key exclusion criteria: * mixed sclc and nsclc histology * active second malignancy * nsclc that is eligible for definitive local therapy alone * has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy * has an active autoimmune disease that has required systemic treatment in past 2 years * has had an allogenic tissue/solid organ transplant. * has severe (≥ grade 3) hypersensitivity to sg, pembrolizumab, carboplatin, or cisplatin, their metabolites, or formulation excipient * has received radiation therapy to the lung * individuals may not have received systemic anticancer treatment within the previous 6 months * is currently participating in or has participated in a study of an investigational agent * clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses * known active central nervous system (cns) metastases * history of cardiac disease * active chronic inflammatory bowel disease * active serious infection requiring antibiotics * active or chronic hepatitis b infection * positive hepatitis c antibody * positive serum pregnancy test or women who are lactating note: other protocol defined inclusion/exclusion criteria may apply.
evaluation of magnetic resonance imaging (mri) vs molecular breast imaging (tc-mbi) in breast cancer patients

Conditions: Breast Cancer

Summary: the objective of this study is to evaluate the usefulness of tc-99m sestamibi molecular breast imaging as an imaging modality for breast cancer screening. tc-mbi has shown significantly higher sensitivity and equivalent specificity in the detection of breast cancer among high risk women when compared to mammography. however, there is little published data comparing tc-mbi to mri for evaluating extent of disease in women with known breast cancer. the study will target twenty (20) women with newly diagnosed breast cancer who are scheduled to undergo biopsy of additional suspicious lesions that were identified on standard of care contrast- enhanced breast mri. prior to the biopsy, these subjects will receive a tc-mbi scan of the breast. the results from both imaging methods will be compared to histological findings. these results may be used to design larger and more comprehensive studies with an overarching goal to determine if there is a role for tc-mbi in the pre-operative evaluation of patients with known breast cancer.


Eligibility criteria:
inclusion criteria: women patients must be 18 years of age or older. patients will have biopsy proven unilateral breast cancer with ipsilateral or contralateral suspicious lesions on contrast-enhanced breast mri and be a candidate for additional tissue biopsy. patients must be able to remain still for tc-mbi scanning patients must be able to provide written informed consent exclusion criteria: men, age less than 18, inability to remain still for tc-mbi scanning, cannot provide written informed consent, known untreated bilateral breast cancer, evidence of distant metastasis disease (m=1), pregnancy.
measure: metreleptin effectiveness and safety registry

Conditions: Generalised Lipodystrophy; Partial Lipodystrophy

Summary: the study is a post-authorization, prospective, voluntary registry of patients treated with commercial metreleptin including, but not limited to, patients in the us and eea.

this is a non-interventional, multicentre, prospective, observational study of patients receiving treatment with commercial metreleptin for lipodystrophy in the us (gl) and eea (gl and pl). this registry will add to the knowledge about metreleptin gained from clinical trials by providing information on the incidence rates of acute pancreatitis associated with the discontinuation of metreleptin; and all cases of fatal or necrotizing pancreatitis, hepatic adverse events, hypoglycemia, hypersensitivity reactions, serious and severe infections, including serious infections resulting in hospitalization and death, loss of efficacy, new diagnoses of autoimmune disorders, exacerbation of existing autoimmune disorders, all cancers (excluding non-melanoma skin cancer) by cancer type, exposed pregnancies, and all-cause deaths, in patients treated with metreleptin in routine clinical practice.

Eligibility criteria:
inclusion criteria: * patients treated with metreleptin through commercial supply at the time or before enrolment into registry * patients who provide a written consent * patient coming off metreleptin clinical studies and continuing or restarting treatment with metreleptin through commercial supply exclusion criteria: • patients currently treated with an investigational agent as part of a clinical trial

Keywords: lipodystrophy metreleptin registry
optimization of percutaenous coronary intervention with liberal use of post-dilatation

Conditions: Coronary Artery Disease

Summary: to achieve optimal long-term clinical results after percutaneous coronary intervention (pci), adequate deployment of stents is essential. thorough expansion of the stent and full apposition of stent struts against the vessel wall are determining factors for preventing stent thrombosis and restenosis for bare-metal as well as drug-eluting stents (des). standard coronary angiography is limited in assessing accurate vessel size and characterizing tissues and calcium load. therefore, stent underexpansion frequently occurs after stent deployment. post-dilation is often performed to achieve optimal stent expansion and reduce stent malapposition of stent struts, aiming to reduce stent thrombosis and restenosis both short term as long term. however, there are limited studies that have explored the effect of post-dilatation for stent optimization on clinical outcomes. as a result of the restricted evidence, there is no consensus whether post-dilatation should be used routinely in clinical practice and the extent to which post-dilatation is being utilized remains unclear. for this reason, the optimize pci was designed, a national registry-based quality improvement project to implement a liberal post-dilatation strategy in multiple pci centers in the netherlands. as part of the optimize-pci, a retrospective observational analysis will eventually be conducted to evaluate whether adopting this strategy has led to improved clinical outcomes after pci in terms of major adverse cardiac events.

the netherlands heart registration (nhr) is an independent organization in which dutch hospitals prospectively register standard sets of baseline, procedural and outcome data for all invasive cardiac procedures, including pci. data provided to the nhr are extensively checked on completeness and quality, reviewed with audit reports by independent trained research nurses and discussed by cardiologists in registration committees. multiple audits are conducted annually by the nhr for data validation and verification. a waiver for informed consent for analysis with the data of the nhr data registry is obtained.

Eligibility criteria:
inclusion criteria: * all patients \>18 years old who undergo pci for any indication are included in the register of the netherlands heart registration and therefore included in the final analysis of this project exclusion criteria: - if a patient has multiple pcis within 365 days, only the first procedure is included.

Keywords: percutaneous coronary intervention coronary artery disease stent optimization post-dilatation
the functional magnetic resonance imaging study on the processing of acute pain and cognition among perimenopause women

Conditions: Menopause; Migraine

Summary: there lacks effective early screen system for the migraine-susceptible women during the peri-menopause period. the processing of acute pain and cognition as well as the underling functional magnetic resonance imaging (fmri) features are suitable for screening pain-susceptible individual. however, there is no study on this issue among the large sample peri-menopause women. the investigators thus designed the current trial to investigate the processing of acute pain and cognition as well as the underling featured functional magnetic resonance imaging (fmri).the investigators will combine pain behavior,cognitive task, fmri analysis, psychophysiological interaction (ppi) and suitable statistical package to investigate the relationship between the above mentioned features and the occurrence of migraine and then test the efficacy of these features in predicting migraine development. the investigators will then try to establish the screening system for migraine-susceptible individuals in peri-menopause women.

although the prevalence of migraine is very high during peri-menopause period, there exist significant individual differences in whether developing migraine among this population. however, there still lacks effective early screen system for the migraine- susceptible women during the peri-menopause period. individual acute pain processing and its interaction with cognition as well as the underling featured functional magnetic resonance imaging (fmri) are suitable for screening pain-susceptible individual. actually, the featured acute pain processing and its interaction with cognition as well as fmri alterations were reported in two previous small sample trials among pre-menopause population, however, there is no similar study on large sample peri-menopause women. the investigators previously reported abnormal acute pain processing and decreased cognition in the experimental peri-menopause rats as well as peri-menopause women with migraine. the investigators thus raised the current hypothesis that the acute pain processing and its interaction with cognition as well as the underling featured functional magnetic resonance imaging (fmri) are usable for screening migraine-susceptible individuals among peri-menopause women. in the current project, the investigators will combine pain behavior,cognitive task, fmri analysis, psychophysiological interaction (ppi) and suitable statistical package to investigated the relationship between the above mentioned features and the occurrence of migraine and then test the efficacy of these features in predicting migraine development. the investigators will then try to establish the screening system for migraine-susceptible individuals in peri-menopause women.

Eligibility criteria:
inclusion criteria: * 25 years old or above * healthy women exclusion criteria: * those with history of present illness * past history of significant neurological and psychiatric disorders or mri contraindication
oral misoprostol versus intravenous oxytocin in preventing blood loss after non-scheduled cesarean section

Conditions: Postpartum Hemorrhage

Summary: postpartum hemorrhage (pph) ranks among the leading causes of maternal morbidity and mortality, both in developed and developing countries. with this trial, we sought to determine the effectiveness of oral misoprostol as an uterotonic drug in comparison with intravenous oxytocin, in patients with a low risk of pph undergoing non-scheduled cesarean section. we therefore compared the intra- and postoperative blood loss, as well as drug related side effects in patients, treated by the same surgical and anesthesiological team in one institution.

postpartum hemorrhage (pph) is still among the leading causes of maternal morbidity and mortality. the incidence of pph is reduced by active management of the third stage of labor which includes the use of uterotonics for pharmacological prophylaxis. however, there is an on-going debate about the optimal drug selection since uterotonics such as oxytocin and methylergometrine are liable for specific side effects and complications when administered within a dose range needed to be effective for pph. in the search for an alternative to these conventional standard uterotonics, misoprostol (prostaglandin e1) has turned out to be an effective therapeutic option and has been implemented in actual treatment regimens. the objective of this study was to compare the effectiveness of oral applicated misoprostol versus intravenous oxytocin in reducing blood loss in low risk obstetric patients undergoing non-scheduled cesarean section (cs) under spinal anesthesia. comparison: in this prospective, double blind study, parturients undergoing cs were randomized to receive either a) oral misoprostol and an infusion of normal saline supplemented with placebo, or b) an oral placebo and an infusion of normal saline, supplemented with oxytocin subsequently to intravenous oxytocin after cord clamping in both groups. the primary outcomes were the amount of intra- and postoperative blood loss and the occurrence of drug-related side effects.

Eligibility criteria:
inclusion criteria: * non-scheduled primary or secondary cesarean section (cs) after the 37th week of gestation exclusion criteria: * emergency cs * fetal distress * fetal malformations * preeclampsia and hellp (hemolysis-elevated liver enzymes-low platelet count syndrome) * hypersensitivity to prostaglandins * coagulopathy * severe systemic disorders * an american society of anesthesiologists (asa) physical status \>/= 3 * severe asthma * prior myomectomy * maternal fever (\> 38.5 °c)

Keywords: maternal morbidity mortality pregnancy postpartum hemorrhage cesarean section
influence of additional physician's consultations and short message service (sms) reminders to patient compliance

Conditions: Lipid Metabolism Disorders

Summary: a systematic collection of retrospective and prospective data based on non-interventional patient observation, aimed to assess the risks, course and outcomes of a disease or a group of diseases: * the retrospective part: database of patients with cardiovascular risks; * the prospective part: observation of patients in the real world medical practice.

the research program will have two parts: stage 1: identification of patients with moderate, high and very high cardiovascular risk, not having diseases of atherosclerotic genesis and requiring lipid-lowering drugs. stage 2: a prospective observation of patients receiving primary medical prophylaxis of cvd with atorvastatin.

Eligibility criteria:
inclusion criteria: data on the following subjects is planned to be collected in the project: * aged from 40 to 65 years inclusively * with a high (≥5%) cardiovascular risk measured by score and low density lipoprotein (ldl) levels of ≥2,5 mmol/l, or with a very high (≥10%) cardiovascular risk measured by score and ldl levels ≥1,8 mmol/l or with atherosclerotic stenosis of brachiocephalic arteries of \>50% in the absence of cerebrovascular disease exclusion criteria: * no contraindications to statin treatment and not taking stating at study entry. * history of the following clinically significant events and conditions: (а) myocardial infarction (б) stroke (в) transient ischemic attack * presence of the following diseases at the time of a statin administration: (а) ischemic heart disease (б) heart failure (в) peripheral artery atherosclerosis (г) atherosclerotic stenosis of brachiocephalic arteries with cerebrovascular disease . subjects must give their consent for processing of their personal data for the purposes of this scientific project.

Keywords: prevention of cardiovascular diseases atorvastatin