Kornimate/medical-research-clean huggingface dataset:
losartan for improved vascular endothelial function after preeclampsia

Conditions: Preeclampsia Postpartum

Summary: women who develop preeclampsia during pregnancy are more likely to develop and die of cardiovascular disease later in life, even if they are otherwise healthy. the reason why this occurs is unclear but may be related to blood vessel damage and increased inflammation that occurs during the preeclamptic pregnancy and persists postpartum. the purpose of this investigation is to determine the mechanisms contributing to this lasting blood vessel damage and to test whether taking a medication that blocks angiotensin ii receptors (losartan) decrease these negative effects in women who have had preeclampsia. identification of these mechanisms and treatment strategies may lead to better clinical management,of cardiovascular disease risk in these women. in this study we use the blood vessels in the skin as a representative vascular bed. using a minimally invasive technique (intradermal microdialysis for the local delivery of pharmaceutical agents) we examine the blood vessels in a nickle-sized area of the skin in women who have had preeclampsia. we make these measurements after the subjects take a placebo and after they take losartan (an angiotensin ii receptor blocker) to test whether this treatment improves vascular function in these women. as a compliment to these measurements, we also draw blood from the subjects and isolate the inflammatory cells to test how sensitive their inflammatory responses are following the placebo and the losartan treatment.


Eligibility criteria:
inclusion criteria: post-partum women, * 18 years or older, * who have delivered within 24 months of the study visit * who have had a preeclamptic pregnancy diagnosed by their obstetrician and confirmed according to the american college of obstetricians and gynecologists criteria for preeclampsia. \[this information will be self-reported by the subjects.\] * using an effective method of birth control and not planning to become pregnant in the next 6 months. exclusion criteria: * skin diseases, * current tobacco use, * diagnosed or suspected hepatic or metabolic disease including chronic kidney disease (ckd) defined as reduced egfr \< 60 ml/min/1.73m2, * statin or other cholesterol-lowering medication, * current antihypertensive medication, * history of hypertension prior to pregnancy, * history of gestational diabetes, * current pregnancy or breastfeeding, * body mass index \<18.5 kg/m2, * allergy to materials used during the experiment.(e.g. latex), * known allergies to study drugs.
use of morphine gel topically in patients with stage 2-3 wounds

Conditions: Wounds

Summary: morphine gel applied topically to wounds will reduce wound pain and decrease patients use of oral and intravenous pain medications, therefore reducing side effects.

patients will be randomized to receive either placebo (versa base gel) or morphine gel to wound. patients receiving morphine gel will have a decrease in pain score and use less oral/intravenous pain medications.

Eligibility criteria:
inclusion criteria: * signed and dated consent form \& hipaa * \> 18 yo * single stage 2-3 wound * no allergy to morphine * alert and oriented (thinking ability clear and intact, physician approval) * english language proficiency exclusion criteria: * allergy to morphine, codeine, or versa base, pts taking medications for acute condition, other than for the wound pain * patients with neuropathies * patients with respiratory conditions
ai-prognosis - digital biomarkers development study (dbm-dev)

Conditions: Parkinson Disease

Summary: dbm-dev study is a multicentre low-intervention research study which concerns rem sleep behaviour disorder (rbd) who is the best predictor for neurodegenerative diseases including parkinson's disease (pd). rbd can only be confirmed by polysomnography, which is a cumbersome procedure. the main objective of this study is to identify a novel, robust dbm for the detection of rbd using smartwatch-based recordings of passive data.the study is conducted step-wise on two subsequent cohorts referred to as the development cohort and the confirmation cohort.

the development cohort comprises 30 patients with rbd and 30 matched controls on sex and age with patients rbd. the confirmation cohort comprises 30 patients with pd. following a baseline visit comprising standard clinical evaluation and parkinson questionnaires, participants will undergo daily-life dbm tracking over a duration of 4 weeks for development cohort and 3 months for confirmation cohort. additionally, pd patients enrolled in the confirmation cohort will receive a polysomnography which permits to verificate if they have a rbd. the investigation is conducted in four european sites.

Eligibility criteria:
inclusion criteria for development cohort: group of rbd patients * diagnosis of rbd (confirmed by polysomnography) * able to use a compatible smartphone with the study app * having a care partner with whom they share their bedroom at night group of healthy matched controls: * healthy volunteers age and sex matched to the enrolled rbd patients. * able to use a compatible smartphone with the study app * no history of rbd. inclusion criteria for confirmation cohort * clinical confirmed diagnosis of pd * rbd screening questionnaire score : 3 - 12 points * absence of dementia * able to use a compatible smartphone with the study app * having a care partner with whom they share their bedroom at night exclusion criteria for all cohorts: inability to consent for study procedures as judged by the investigator. lacking motivation to participate in study procedures as judged by the investigator. lack of social security.

Keywords: rem sleep behaviour disorder
clofarabine in chinese pediatric patients with refractory or relapsed acute lymphoblastic leukemia

Conditions: Acute Lymphoblastic Leukemia

Summary: outcomes for children with relapsed/refractory (r/r) acute lymphoblastic leukemia (all) are dismal. therefore, the investigators performed this multicenter, phase ii study to evaluate the efficacy and , safety and pharmacokinetic of clofarabine in chinese pediatric patients with r/r all


Eligibility criteria:
inclusion criteria: * pediatric patients (younger than 21 years old) with acute lymphoblastic leukemia confirmed by histology * refractory or relapsed acute lymphocytic leukemia who had received at least two drugs treatment * no prior chemotherapy within 2 weeks before entry and resolution of toxic effects from prior therapy * normal cardiac function, adequate hepatic function \[total bilirubin ≤1.5× upper limit of normal (uln), aspartate aminotransferase (ast) alanine aminotransferase (alt) ≤ 3uln\] and renal function (serum creatinine ≤ 2 uln) * eastern cooperative oncology group (ecog) performance status 0-2 * life expectancy more than 3 months exclusion criteria: * aes not recovered from prior therapy * within 3 months from allogeneic or autologous stem cell transplantation * with central nervous involvement or uncontrolled infection * patients who used clofarabine before or allergic to fludarabine or cladribine
evaluation of low and high nicotine tobacco free nicotine pouches

Conditions: Cigarette Smoking; Nicotine Dependence; Smoking Cessation

Summary: tobacco-free oral nicotine pouches (such as zyn brand) are a less harmful alternative to cigarette smoking. pouches, however, contain nicotine, and addictive substance that is not risk-free. the present study is evaluating how well nicotine pouches, at different nicotine levels, help people switch away from smoking cigarettes. people who smoke cigarettes will be asked to answer questions about their tobacco product use and provide breath samples and cheek swab samples at an in-person visit to musc charleston. participants will then be provided with a 28-day supply of nicotine pouches, and will be asked to switch from smoking to pouches over the course of 4 weeks. finally, participants will complete a final visit at musc, and will answer more questions about their tobacco use 1-month later.

the proposed research project evaluates the potential for tobacco-free oral nicotine pouches (tfnps) to serve as harm reduction tools at two nicotine concentrations, inclusive of behavioral and biomarker outcomes, using a clinical trial design. specifically, in a randomized pilot study, participants who smoke will be recruited and sent tfnps to sample for 4 weeks in either high (6 mg) or low (3 mg) nicotine content strengths. participants will report tobacco use behaviors and submit biological samples throughout the study. this design allows for evaluation of the effect of nicotine content within alternative, harm-reducing tobacco products on key outcomes including: 1) complete switching from cigarette smoking to non-cigarette product use; 2) cigarette smoking reduction; 3) changes in biomarkers of harm (dna damage, respiratory symptoms), 4) nicotine dependence, and 5) subjective effects of product use.

Eligibility criteria:
inclusion criteria: * age 21+ * current cigarette smoking (25+ days per previous month, 5 or more cigarettes/day, for greater than 1yr, greater than 100 lifetime cigarettes) * have not used tnfps more than 5 times during their lifetime * willing and able to attend 2 in-person visits in charleston (to assess biomarkers) * have internet access exclusion criteria: * lack of proficiency in english. * use of other combustible tobacco products (i.e., cigars, cigarillos, hookahs) and/or other non-combusted nicotine/tobacco products (i.e., e-cigarettes, smokeless tobacco) in the past 30 days. * current use of smoking cessation medications (i.e., varenicline, bupropion, nicotine replacement therapy). * use of marijuana within the past month, and unwillingness to abstain from marijuana during course of study. * medical conditions contraindicated to nrt use (including pregnancy, breastfeeding, and nursing, past month myocardial infarction, current untreated cardiac arrhythmia, current severe angina, current uncontrolled severe vascular disease).

Keywords: smoking
evaluation of the safety, systemic pharmacokinetics, and tolerability

Conditions: Eye Pain

Summary: evaluation of the safety, systemic pharmacokinetics, and tolerability of single and repeat ocular instillations of loteprednol etabonate ophthalmic gel, in normal healthy volunteers

the primary objective of this study is to evaluate the systemic pharmacokinetics (pk) of le (loteprednol etabonate ophthalmic gel), 0.38% in normal healthy volunteer subjects at least 18 years of age and with a normal ophthalmic history. systemic pk will be assessed in this study after a single dose and after 2 weeks of daily bid dosing.

Eligibility criteria:
key inclusion criteria: * are able to read, understand and provide written informed consent on an informed consent form (icf) approved by the institutional review board (irb)/independent ethics committee (iec). * be a non-smoking male or female at least 18 years of age on the date the icf is signed and with the capacity to provide voluntary informed consent. * be in general good health and free of any concomititant conditions or treatment that could interfere with study conduct, influence the interpretation of study observations/results, or place the subject at increased risk during the study. * be willing/able to return for all required study visits and follow instructions from the study investigator and his/her staff. * are able to self-administer eye drops or have a clinical staff member deliver the single dose of investigational product (ip) on specified study days. * have a normal physical examination and clinical laboratory evaluation key exclusion criteria: * have a history/presence of chronic generalized systemic disease that the investigator feels might increase the risk to the subject, confound the result(s) of the study, or preclude study treatment or follow-up. * have any current disease or medical condition that requires medicinal therapy. * have a history of drug or alcohol abuse in the last 6 months. * have a positive urine screen for alcohol, amphetamines, barbiturates, benzodiazepines, cocaine (or cocaine metabolite), cannabinoids, methadone, methamphetamine, opiates and/or phencyclidine. * are known to have a prior positive blood screen for hepatitis b surface antigen, hepatitis c antibody, or human immunodeficiency virus types 1 and 2.
patient initiated note about goals

Conditions: Chronic Disease

Summary: this is a randomized controlled trial of the patient-initiated note about goals (ping).

the ping is a brief survey designed to elicit patients' goals, preferences, and preferred surrogate decision-maker. in the ping study, patients will be assigned to receive either a nurse-administered ping or usual care. outcomes include ping completion, subsequent goals of care conversations with providers, and healthcare utilization.

Eligibility criteria:
inclusion criteria: * patient referred for annual wellness visit at participating clinic exclusion criteria: * non-english speaking
acceptance and mindfulness for exercise in anxiety

Conditions: Anxiety

Summary: anxiety is a common experience, with the u.s. lifetime prevalence of any anxiety disorder at 28.8%. exercise has shown large effect sizes relative to controls in reducing mood and anxiety symptoms. an anxious population generally has more difficulty when beginning or increasing an exercise regimen, due to a higher level of sensitivity to discomfort. mindfulness practices may be helpful in improving adherence to an exercise program. a similar study has shown that mindfulness may reduce perceived effort and make exercise more enjoyable. furthermore, mindfulness has been shown to be an effective intervention in reducing anxiety and physical discomfort. the investigators intend to use a brief intervention incorporating strategies of mindfulness and acceptance and commitment therapy (act) in conjunction with exercise to ease the transition into regular/increased physical exercise. measures of anxiety sensitivity and perceived stress will be included to measure whether they change, and their possible effect as moderating variables on exercise adherence.


Eligibility criteria:
inclusion criteria: * students who are enrolled in psychology 301 at the university of texas at austin, as well as adult and student volunteers recruited from the university of texas at austin campus and the greater austin community, who are 18-65 will be eligible for this study. * participants must exercise less than 150 minutes per week doing moderate-intensity exercise consistently within the last two months. * they will have at least mild anxiety, as measured with either a minimum score of 8 on the beck anxiety inventory, or 5 on the generalized anxiety disorder-7. exclusion criteria: * those that are at moderate or high risk based on the pre-participation exercise health screening by the american college of sports medicine, or any participants that have been advised to not participate in exercise or aerobic activity by a qualified medical provider. * those with cardiovascular or pulmonary diseases, immunological diseases, neurological disorders, or have serious bone or joint problems. * the beck depression inventory's item on suicidality will be actively checked for a response of 2 or 3, with further screening given to those participants using questions from the c-ssrs to screen for current suicidal ideation and past suicidal behavior. participants who endorse imminent intent or a plan to act on suicidal thoughts will be immediately referred to one of the imhr's psychologists, or 911 will be contacted if they are at immediate risk of suicidal self-harm. participants endorsing intent or a specific plan will not be included in the study. participants expressing suicidal thoughts without imminent intent or a specific plan will be given resources to pursue mental health treatment.
prognosis of resection and radiotherapy in the treatment of intrahepatic cholangiocarcinoma patients

Conditions: Intrahepatic Cholangiocarcinoma

Summary: the purpose of this study is to confirm that prognosis of intrahepatic cholangiocarcinoma (icc) with resection and radiotherapy ,to find which is safe and effective treatment.

intrahepatic cholangiocarcinoma (icc), the second most common primary liver cancer and constitutes 10% of primary liver malignancies. current therapies for the treatment of icc are ineffective and the role of liver transplantation is not well defined. this study reviews our experience with this tumor and looks for preoperative and pathologic indices that may help determine long term prognosis

Eligibility criteria:
inclusion criteria: * male or female patients \> 17 years and \<=60 years of age. confirmed case (patients with icc) tumors can be radical removed and resection volume was ≤50%. criteria of liver function: child a level, serum bilirubin ≤ 1.5 times the upper limit of normal value,alanine aminotransferase and aspartate aminotransferase ≤ 2 times the upper limit of normal value. no dysfunction in major organs; blood routine, kidney function, cardiac function and lung function are basically normal. hbg ≥ 90g/l, wbc ≥ 3.000 cells/mm³,platelets ≥ 80.000 cells/mm³. karnofsky performance score performance over 60. patients who can understand this trial and have signed information consent. exclusion criteria: * patients who have undergone previous treatment by resection or radiotherapy. patients with apparent cardiac, pulmonary, cerebronic and renal dysfunction, which may affect the treatment of liver cancer. patients with other diseases which may affect the treatment mentioned here. patients with medical history of other malignant tumors. subjects participating in other clinical trials. extrahepatic metastasis, portal vein or other major vascular involvement. liver function: child b c. patients would not sign the consent to the trial.

Keywords: intrahepatic cholangiocarcinoma prognosis resection radiotherapy
impact of myofuntional therapy program on increasing tongue strength and improving sleep apnea

Conditions: Obstructive Sleep Apnea

Summary: this research studies for compare muscle strength among osa patients who treat with myofunctional therapy program in rajavithi hospital


Eligibility criteria:
inclusion criteria: * patients who diagnose with obstructive sleep apnea 18-65 years exclusion criteria: * bmi\>=35kg/m2 * alcoholic and smoke * use sleeping pill * craniofacial syndrome * hypertrophic tonsils grade 3+, 4+ * severe comorbidity * use cap

Keywords: myofunctional therapy iopi obstructive sleep apnea (osa)
an investigational immuno-therapy study for safety of nivolumab in combination with ipilimumab to treat advanced cancers

Conditions: Lung Cancer

Summary: a study to evaluate the safety of nivolumab given in combination with ipilimumab in patients with advanced cancers. the initial group will enroll patients with newly diagnosed stage 4 or non-small cell lung cancer that has come back.


Eligibility criteria:
inclusion criteria: * histologically confirmed stage 4 or recurrent non-small cell lung cancer * eastern cooperative oncology group (ecog) score 0-1 (physically able to carry out light housework or office work through to being fully active as you were before cancer) * no prior systemic anticancer therapy (including egfr and alk inhibitors) * tissue or programmed death-ligand 1 (pd-l1) results available cohort 1a inclusion criteria: * eastern cooperative oncology group (ecog) score 2 or * eastern cooperative oncology group (ecog) score 0-1 and one disease specific criteria as listed in the protocol cohort c inclusion criteria: * high tumor mutation burden exclusion criteria: * untreated brain metastases * an active malignancy that requires concurrent intervention * active, known or suspected autoimmune disease * carcinomatous meningitis, which means there is inflammation of the covering of the brain, caused by cancer other protocol-defined inclusion/exclusion criteria apply
effectiveness of musicotherapy in reducing pain induced by leg ulcer care

Conditions: Debridement Care; Leg Ulcer; Leg Ulcers Venous; Pain

Summary: venous leg ulcer is the final stage of chronic venous disease and only develops due to advanced chronic venous insufficiency. the problems caused by venous disease are initially minor and often neglected, but can impact the quality of life of patients. the prevalence of leg ulcers is estimated at 1% of the general population and 3% to 5% of subjects over 65 years old. its prevalence increases with age in both men and women. managing chronic ulcers requires a certain number of care procedures, including debridement. the act of treatment by mechanical debridement is little relieved by the analgesics given beforehand, and can be painful, with risks of bleeding. musicotherapy, particularly the u-shaped method, has shown its effectiveness in the treatment of pain and anxiety in several areas (geriatrics, intensive care, rheumatology, oncology, etc.). the standardized musicotherapy method of the u-shaped sequence was developed and initially evaluated by clinical studies coordinated by the inserm unit u1061 (pr. jacques touchon; dr. stéphane guétin). following the publication of numerous controlled, randomized studies presenting results on the effectiveness in the treatment of pain and anxiety, a digital application was developed in order to standardize the method. the music care health application is now a class 1 medical device, with ce marking obtained. this "u-shaped sequence" is standardized and has been clinically validated, which makes music care a unique tool available for pain relief. no studies have been found in the literature regarding the use of music therapy during debridement care.


Eligibility criteria:
inclusion criteria: * adult patient, * patient followed at the m@dicicat healing center requiring wound debridement : * for a venous or arterial ulcer or necrotizing angiodermatitis of the lower limbs, * having the ability to verbalize about their pain (communicating), * with a planned debridement time of less than 40 minutes. * patient affiliated to or beneficiary of a social security scheme, * patient having given free, informed and express consent. exclusion criteria: * patient with a diabetic foot (loss of sensitivity-neuropathy), * patient not requiring a debridement session, * patient with an infected ulcer (abscess, etc.), * patient with critical ischemia, * patient with hearing problems, * patient with cognitive disorders, * patient placed under legal protection, guardianship or curatorship, * pregnant or breastfeeding woman.

Keywords: debridement venous leg ulcer pain