Kornimate/medical-research-clean huggingface dataset:
cyclosporine in treating patients with recurrent or refractory angioimmunoblastic t-cell lymphoma

Conditions: Lymphoma

Summary: rationale: cyclosporine may help the immune system slow the growth of angioimmunoblastic t-cell lymphoma. purpose: this phase ii trial is studying how well cyclosporine works in treating patients with recurrent or refractory angioimmunoblastic t-cell lymphoma.

objectives: primary * determine the response rate (complete and partial) in patients with recurrent or refractory angioimmunoblastic t-cell lymphoma treated with cyclosporine. secondary * determine the disease-free, progression-free, and overall survival of patients treated with this drug. * determine the toxicity of this drug in these patients. outline: patients receive oral cyclosporine twice daily for up to 36 weeks in the absence of unacceptable toxicity or disease progression during weeks 1-6. patients experiencing disease progression during weeks 7-36, receive an additional 36 weeks of therapy. patients are followed every 3 months for 2 years and then every 6 months for 1 year. projected accrual: a total of 27 patients will be accrued for this study within 2.5 years.

Eligibility criteria:
inclusion criteria: * diagnosis of angioimmunoblastic t-cell lymphoma (recurrent or refractory) based on histologic examination. * at least one objective measurable or evaluable disease parameter. * have failed at least one type of treatment: chemotherapy, auto-transplant, or steroid treatment. patients may not receive concurrent chemotherapy. * eastern cooperative oncology group (ecog) performance status of 0-2. * adequate renal function as indicated by creatinine \<= 1.5 the upper limit of normal (uln). * adequate liver function as indicated by alkaline phosphatase, aspartate aminotransferase (ast), and alanine aminotransferase (alt) \<= 2x the upper limit of normal. * total bilirubin \<= 2x the upper limit of normal. * age 18 or older. exclusion criteria: * prior cyclosporine or tacrolimus (fk506). * prior allogeneic transplant. * evidence of active infection. * congestive heart failure, kidney failure, liver failure, or other severe co-morbidities. * evidence of active neurological impairment. * previous history of hypersensitivity to cyclosporine and/or cremorphor el (polyoxyethylated oil). * history of other malignancies (other than cured carcinomas in situ of the cervix or basal cell carcinoma of the skin). * pregnant or breastfeeding women. * human immunodeficiency virus (hiv) positive.

Keywords: angioimmunoblastic t-cell lymphoma
garden of life once daily women's probiotic: vaginal ph and quality of life study

Conditions: Vaginal Health

Summary: this decentralized observational study is designed to understand the effects of daily consumption of once daily woman's probiotic (odwp) on vaginal ph levels in healthy female populations ages 19-70 years of age across the united states.

this decentralized observational study is designed to understand the effects of daily consumption of once daily woman's probiotic (odwp) on vaginal ph levels in healthy female populations ages 19-70 years of age across the united states. participants will be divided into two cohorts of 100 participants each; one with a history of vaginal bacteriosis and one with no history of bacterial vaginosis, with between 20-30 percent of the total participants being post-menopausal. participants will be provided and trained to use ph tests on a daily basis over the course of four menstrual cycles (or equivalent time for amenorrheic participants). during the first cycle (or equivalent timeframe) of measurement, participants will not consume neither placebo or once daily woman's probiotics (odwp); allowing the establishment of a baseline or wash out period prior to active consumption and measurement of effect. participants will receive odwp at no charge for consumption over the course of the study. participants will be instructed to start and continue consumption over three menstrual cycles (or equivalent timeframe) based on participant's menstrual status and her demonstrated ability to self-measure and report vaginal ph via the validcare study app based platform (aka "the app), which is provided as a free, downloadable 21 cfr part 11 compliant interface for all patient facing activities and communication with/from the principal investigator for the study duration.

Eligibility criteria:
inclusion criteria: 1. age: 19-70 (21-70 for residents of mississippi) 2. non-menopausal women must have a regular menstrual cycle (26-32 days) 3. using birth control 4. sexually active (intercourse at least 2x/month) 5. agree to not introduce any other probiotic during the three months of study exclusion criteria: 1. ocp or systemic hormonal contraception 2. no antibiotic treatment for at least 30 days 3. no active vaginal infection or symptoms of infection 4. no probiotic use for 30 days 5. routine douching (except for immediately after menses)

Keywords: probiotics bacterial vaginosis vaginal ph
comparison of chest ultrasound techniques to identify clinically significant pneumothorax

Conditions: Pneumothorax

Summary: patients with chest trauma undergo ultrasound to detect a collapsed lung. two techniques have been described. a single view for each hemi-thorax, and multiple views for each hemithorax. the investigators are comparing these two techniques in a randomized prospective trial.

this is a randomized, prospective blinded study on trauma patients arriving to an emergency department. study setting and population this study will be conducted on the university campus of the university of massachusetts medical center, which is an urban academic emergency department that sees 80,000 patients annually and has a dedicated level i trauma service that is staffed by trauma surgery and emergency medicine. adult patients with acute traumatic injury who are undergoing a ct scan of the chest are eligible for enrollment. study protocol trauma patients are enrolled as they arrived to the emergency department. the investigators will include any trauma patient aged 18 and over. the investigtors will exclude any patient who was too unstable and required clinical care that prevented performing a chest wall ultrasound, patients with a chest tube in place prior to arrival, pregnant women, and prisoners. imaging decisions on trauma patients will be made early on in their evaluation. the patient will be assigned using a pre-determined randomization scheme to a single view or four views of each hemi-thorax prior to any imaging being done. ultrasounds will be performed and interpreted by credentialed physicians using a 7.5mhz linear array transducer on a portable ultrasound machine (zonare z.one ultra) with digital clips recorded for later review. when the investigators obtain a single view of each hemi-thorax, the probe will be placed in a longitudinal orientation on the midclavicular line in the third intercostal space. when the investigators obtain four views of each hemi-thorax, the first image location will be the same as in the single view and then the probe will be moved inferiorly and laterally to obtain the additional three images. immediately following the ultrasound examination, the patient will be transported to the ct scanner for further imaging. the goal of this study is to determine if a single view of each hemi-thorax can identify a pneumothorax or if additional images should be included. the primary study endpoint is the presence of a pneumothorax on ultrasound.

Eligibility criteria:
inclusion criteria: * patients who had trauma and are receiving a chest ct. exclusion criteria: * clinically unstable * clinical care prevented ultrasound * patient with a chest tube in place * pregnant women * prisoners
circulating tumor dna as a prognostic marker in patients with pancreatic cancer

Conditions: Pancreatic Cancer

Summary: the aim of this study is to determine the usefulness of circulating tumor dna as a prognostic factor in patients with pancreatic cancer.

there is currently no strong prognostic factor in pancreatic cancer. k-ras is the most commonly mutated gene in pancreatic cancer, with a mutation rate of 75% to 95%. these high mutation rates are expected to be useful for diagnosis and prognostic factors in future. currently, k-ras mutation tests are often performed in tissues, and there are various limitations, in particular, limited obtaining of sufficient tissues. in this regard, analyzing the prognosis of pancreatic cancer through non-invasive blood testing has significant advantages. and prognosis analysis through blood tests can be done through blood circulating tumor dna. the relationship between prognosis and blood circulating tumor dna has already been studied in other cancers such as colorectal cancer, and there have been several studies in pancreatic cancer. however, there are not many research results yet, and there are cases in which the results differ from study to study. therefore, the purpose of this study is to compare the overall survival of patients with pancreatic cancer diagnosed by eus-fna according to the presence and amount of blood circulating tumor dna with k-ras mutation.

Eligibility criteria:
inclusion criteria: * patients diagnosed with pancreatic cancer through eus-fna. exclusion criteria: * severe mental illness * severe co-morbidity (esrd, advanced copd, severe heart failure, poorly controlled blood sugar) * pregnancy * patients who have received chemotherapy * coagulopathy
user acceptability of a device-based opioid overdose intervention

Conditions: Opioid Overdose; Opioid-use Disorder; Substance Use Disorders

Summary: this pilot study evaluates the needs of opioid users for a device-based intervention for opioid overdoses. the results of this one-time short questionnaire will inform development of a novel naloxone delivery device.

all opioid overdose related deaths can be prevented with the timely delivery of naloxone. this study is a one-time, preliminary survey of participants with opioid use disorder to assess the need for, and community attitudes towards, a wearable device capable of autonomously detecting and responding to an opioid overdose. the results of this survey will be used to guide ongoing development of a de novo device. this study will be conducted over a 3 month period and survey participants from the kensington neighborhood in north philadelphia.

Eligibility criteria:
inclusion criteria: * have used opioids for more than 3 months or will be having surgery where opioids will be administered * able to provide informed consent * moderate to severe chronic pain treated with opioids or recreational use exclusion criteria: * pregnancy

Keywords: naloxone delivery survey
iv paracetamol, dexketoprofen or morphine for the treatment of low back pain

Conditions: Low Back Pain

Summary: this randomized, controlled trial evaluates the analgesic efficacy and safety of intravenous single-dose paracetamol, dexketoprofen and morphine for the treatment of low back pain.

study design and setting: this is a single-center, prospective, randomized, double-blind, clinical trial performed in an ed of a tertiary care hospital with annual census of approximately 37.000 visits. the local ethics committee approved the study. interventions: we conducted a randomized, controlled clinical trial comparing single intravenous doses of paracetamol (1 g), dexketoprofen (50 mg) and morphine (0.1 mg/kg) for patients presenting to the emergency department (ed) with suspected low back pain. subjects with inadequate pain relief at 30 minutes received rescue fentanyl (0.75 microg/kg). we compared changes in pain intensity 30 minutes after treatment. methods of measurements: subjects reported pain intensity on both a 100-mm visual analogue scale (limited by 'no pain' and 'the worst pain') and a 4-point verbal rating scale (no pain, mild, moderate, or severe pain) just before the drug administration, 15th minutes and 30th minutes after the study drug administration. the demographic features of study patients and adverse effects, nausea, vomiting, dizziness, vertigo, headache, hypotension, altered mental status, allergic reaction, itching, urinary retention, thoracic rigidity, respiratory depression and dry mouth, were recorded to the study form. outcome measures the primary outcome measure was the pain reduction in vas and vrs at 15th and 30th minutes. secondary outcome measures were the need for rescue drug and the presence of any adverse event. primary data analysis: the present study was planned as a superiority trial. when the 20 mm difference in vas is accepted as clinically significant and the standard deviation is accepted as 25 mm, 35 patients are needed with each group with 95% power. all the analysis were implemented according to the intention to treat analysis. the precise of differences between time intervals within groups and between groups and statistical significance were expressed by 95% confidence intervals (95% ci).

Eligibility criteria:
inclusion criteria: * adults (aged 16 to 55 years) with acute low back pain were eligible for inclusion in the study- - exclusion criteria: * exclusion criteria included known allergy or contraindication to morphine, paracetamol,dexketoprofen or any opioid analgesic * hemodynamic instability * fever (temperature \>38°c \[100.4°f\]) * evidence of peritoneal inflammation * documented or suspected pregnancy * known or suspected aortic dissection or aneurysm, lombar disc hernia * use of any analgesic within 6 hours of ed presentation * previous study enrollment. * patients with known renal, pulmonary, cardiac, or hepatic failure, as well as those with renal transplantation, were also excluded.

Keywords: low back pain paracetamol dexketoprofen morphine
a mobile smart exercise support program to improve fatigue in lung cancer patients - a rct

Conditions: Lung Cancer

Summary: lung cancer (lc) is a common cancer in the world. among all symptoms, fatigue is considered as the most distressing medical condition of lc. prior studies revealed that physical activity effectively relieve fatigue and related problems. the current study attempt to explore the effectiveness of smart exercise support program (ses) with the use of mobile instant messaging application, on reducing symptoms such as fatigue, and improving physical activity level, physical fitness performance, sleep quality and habits, and quality of life in advanced lung cancer (alc) patients.

lung cancer (lc) is the most and second most common cancer globally and locally, respectively. nearly half of lc patients are diagnosed in the advanced stage. fatigue is perceived to be the most distressing symptom. physical activity has been proposed as an alternative treatment to relieve fatigue and related problems. mobile instant messaging applications (e.g. whatsapp/wechat) are popular and inexpensive for interactive messaging. a systematic review showed a majority of messaging interventions were effective in diabetes self-management, weight loss, physical activity (pa), smoking cessation, and medication adherence. the proposed randomized controlled trial (rct) aims to examine the effectiveness of ses on relieving fatigue, pain, dyspnea, happiness, anxiety and depression symptoms, physical activity level, physical fitness performance, sleep quality and habits, and quality of life in alc patients (ses group), compared to the general hygiene information (ghi, control) group. questionnaires and simple fitness tests will be used at baseline, 6-week, and 24-week assessments. qualitative feedback will be obtained at the completion of the trial.

Eligibility criteria:
inclusion criteria: * aged 18 years and above; * diagnosis of stage iii or iv non-small cell lung cancer; * edmonton symptom assessment system scale fatigue symptom score ≥4 out of 10 * self-reported engagement of \<150 minutes of moderate intensity pa each week, * ambulatory and capable of all self-care activities (european co-operative oncology group (ecog) performance status of ≤2) * either undergoing or finished oncology therapy, biological agents and/or support care; * mentally, cognitively and physically fit to join the trial as determined by the doctor in-charge and responsible clinical investigators; * able to speak and read chinese; * willing to complete the patient-reported outcome questionnaire; * completion of the physical activity readiness questionnaire; and * possession of a smartphone with instant messaging functions such as whatsapp or wechat. exclusion criteria: * those preparing for lung operation; * skeletal fragility; * serious active infection; * inability to walk; * previously untreated symptomatic brain metastases; * severe respiratory insufficiency; * uncontrolled pain; or * diagnosed psychiatric illness with or without medication such as major depressive disorder.
epigenetics and the origin of muscle insulin resistance in humans

Conditions: Diabetes Mellitus Type 2 in Obese; Obesity

Summary: the investigators are trying to understand the role of dna (deoxyribonucleic acid) methylation in insulin resistance in skeletal muscle and blood tissues. dna methylation is a normal chemical process in the body that modifies dna. by studying this, the investigators hope to better understand the causes of insulin resistance.

insulin resistance is defined as the decreased ability of insulin to perform its biological function in the muscle, liver and fat. genetic and environmental factors are known to influence insulin sensitivity. it is not known how this is mediated. this study looks at the role of epigenetics (modifications of proteins associated with dna and methylation of dna) in alterations in insulin resistance. we will study lean healthy people, obese non-diabetic people and people with type 2 diabetes to characterize the dna methylation patterns in muscle in each group. the second aim of the study is to see how a single bout of exercise affects the dna methylation in the muscle. the third aim looks at the effect of 8 weeks of supervised exercise on the dna methylation.

Eligibility criteria:
volunteers must be: * 21 - 55 years old * must be non-lactating, non-pregnant * not taking medications known to affect glucose or if taking them, on stable doses. * free of significant heart or lung disease

Keywords: insulin resistance exercise type 2 diabetes mellitus obesity epigenetic studies
pilot study of the effects of the desipramine on the neurovegetative parameters of the child with rett syndrome

Conditions: Rett Syndrome

Summary: rett syndrome is a neurodevelopmental disorder characterized by cognitive impairment, communication dysfunction, stereotypic movement disorder, and growth failure. rett syndrome is caused by mutations in the methyl cpg-binding protein-2 (mecp2) gene and has no treatment. a mouse experimental model of rett syndrome created by genetic invalidation of the mecp2 gene is available. it had been then observed that adult mecp2-deficient mice show respiratory alterations and found that endogenous noradrenaline helps to maintain a normal respiratory rhythm. desipramine, a selective inhibitor of norepinephrine reuptake, seems to be efficient to reduce the respiratory alteration occuring in mecp2-deficient mice (insem patent 2005, villard and roux 2006). the aim of the study is to evaluate these obtained results in mecp2-deficient mice on patients with rett syndrome.

rett syndrome is a neurodevelopmental disorder characterized by cognitive impairment, communication dysfunction, stereotypic movement disorder, and growth failure. the diagnosis of rett syndrome is based on consensus clinical criteria. rett syndrome is caused by mutations in the methyl cpg-binding protein-2 (mecp2) gene and has no treatment. only a few improved cases have been reported concerning buspirone (andaku, 2005, 1 patient), topiramate (goyal, 2004, 8 patients), diazepam (kurihara, 2001, 1 patient) and carnitin (plochl, 2004, 1 patient). only one randomized study versus placebo has been published about a treatment by naltrexone including 25 patients. a light improvement of respiratory parameters was then observed with a deterioration of the cognitive function (percy, 2004). a mouse experimental model of rett syndrome created by genetic invalidation of the mecp2 gene is available. it had been then observed that adult mecp2-deficient mice show respiratory alterations and found that endogenous noradrenaline helps to maintain a normal respiratory rhythm. desipramine, a selective inhibitor of norepinephrine reuptake, seems to be efficient to reduce the respiratory alteration occuring in mecp2-deficient mice (insem patent 2005, villard and roux 2006). the aim of the study is to evaluate these obtained results in mecp2-deficient mice on patients with rett syndrome.

Eligibility criteria:
inclusion criteria: * rett syndrome; * girls weighing less than 60 kg; * respiratory alteration; * diagnosis of rett syndrome confirmed by mecp2 genotyping (xq28). exclusion criteria: * boys; * pregnancy and breath feeding; * case history of status epilepticus; * patient treated by imao or sultopride; * hepatic or renal failure.

Keywords: rett syndrome
cycle ergometer training and heart failure on heart rate recovery and mind fullness

Conditions: Heart Failure NYHA Class I; Heart Failure NYHA Class II

Summary: to evaluate the effects of cycle ergometer training on heart rate recovery in newyork heart association (nyha) class i and ii heart patients. to evaluate the effects of cycle ergometer training on mind fullness in nyha class i and ii heart patients. previous studies were designed to target only cardiac functions and no psychological aspect was studied so this study cover this aspect as well so from the outcomes of this study we can determine both psychological satisfaction and cardiac function as well.

a review stated that "clinical and experimental data shows that physical training is an important aspect in the management of chronic heart failure patients. also, it stated that physical exercise training plays an important role to modulate peripheral immune responses if congestive heart failure (chf) patients show high pro-inflammatory cytokines, soluble cellular adhesion molecules, which further resulted in an improvement in exercise capacity in chf patients. heart rate recovery (hrr) improved in patients who were enrolled in the cardiac rehabilitation stage 2 program while similar outcomes were not noted among the control group. it was concluded that cardiac rehabilitation exercise program improves heart rate recovery. also, hrr may be used in a cardiac rehabilitation program to recognize high risk factors and also useful in evaluating the outcomes. a systematic review about the effects of exercise training in patients with chf was published who concluded that short-term physical exercise training in selected subgroups of patients with chf, has physiological benefits and positive effects on quality of life. a meta-analysis by the collaborative group concluded that there is no evidence that supervised medical training programs for patients with chf are dangerous and indeed there is clear evidence of an overall reduction in mortality. the authors did not perform a quantitative analysis on the outcome of cardiac performance, exercise capacity, or quality of life.

Eligibility criteria:
inclusion criteria: * vitally stable patients with hf 6-8 weeks post-discharge from the hospital * nyha class i, ii * ef: 25-40% exclusion criteria: * arrhythmias /regular pvc/permanent pacemaker/tpm * any systematic disease /infections * uncontrolled dm/htn * unable to perform the 6-min walk test

Keywords: cycle ergometer heart rate recovery mindfulness heart failure