Kornimate/medical-research-clean huggingface dataset:
effect of a polyphenol rich diet on vascular and platelet function

Conditions: Hypertension

Summary: previous work has shown that increasing fruit and vegetable intake in patients with high blood pressure improves cardiovascular function. research indicates that this may be partly owing to compounds called polyphenols, which are found in abundance in fruits and vegetables and other foods such as wine, tea and dark chocolate. the investigators now wish to test if consuming fruits and vegetables (including berries which are very rich in polyphenols), as well as dark chocolate, has further benefits for cardiovascular function. a total of 110 subjects with high blood pressure will be recruited and asked to follow a low polyphenol diet (2 portions of fruit and vegetables daily and no berries or dark chocolate) for four weeks (a washout period). they will then be randomised to continue this diet or to consume 6 portions of fruits and vegetables (to include 1 portion berries) and 1 portion of dark chocolate daily for 8 weeks. the fruit, vegetables and dark chocolate will be provided free of charge and delivered to the homes of the participants who are randomised to the high fruit and vegetable arm of the study. assessment of microvascular and platelet function will be undertaken before and after consuming this diet. improvements in these tests of cardiovascular function have previously been linked to reduced risks of heart disease in people with high blood pressure. this study will provide evidence as to whether or not a polyphenol rich diet can reduce the risk of developing heart disease.


Eligibility criteria:
inclusion criteria: * age 40-65 years old * systolic blood pressure 140-179 mmhg or diastolic blood pressure 90-109 mmhg exclusion criteria: * diabetes mellitus * an acute coronary syndrome or transient ischaemic attack within the past 3 months * special dietary requirements, food sensitivities or vegetarian/vegan diet by choice * oral anticoagulation therapy * body mass index greater than 35kg/m2 * excessive alcohol consumption (defined as \> 28 units/week in men and 21 units/week in women) * fasting triglyceride concentration \> 4 mmol/l * pregnancy/lactation * taking antioxidant supplements * medical conditions or dietary restrictions that would substantially limit ability to complete the study requirements

Keywords: hypertension microvascular function
neramexane for tinnitus

Conditions: Tinnitus

Summary: tinnitus is commonly referred to as "ringing of the ears" - the perception of sounds in the absence of an external source of acoustic signals. tinnitus may represent a severe disease and symptoms include depression, sleeping difficulties, decreased sound tolerance and hearing loss. one hypothesis is that tinnitus is caused by an increased activity of nmda glutamate and dysfunctional alpha9/alpha10 acetylcholine receptors in the inner ear and central nervous system. neramexane may alleviate tinnitus symptoms due to its nmda and alpha9/alpha10 nach receptor blocking activity. the purpose of this study is to assess the safety and efficacy of neramexane compared with placebo in patients with subjective tinnitus.


Eligibility criteria:
inclusion criteria: * main inclusion criterion: persistent, subjective, uni- or bilateral tinnitus exclusion criteria: * main exclusion criterion: intermittent or pulsatile tinnitus
a study to assess the effect of hepatic function on the pharmacokinetics and safety of asp1941

Conditions: Liver Disease

Summary: the purpose of this study is to evaluate the pharmacokinetics (pk) and safety following oral administration of asp1941 in subjects with moderate hepatic impairment and in subjects with normal hepatic function based on the child-pugh classification (cpc).

study drug will be orally administered on day 1. subjects will be admitted to the clinic until completion of clinic discharge procedures on day 7 with an outpatient follow-up visit 6-9 days after clinic discharge.

Eligibility criteria:
inclusion criteria: * subjects with moderate hepatic impairment * agrees to practice highly effective birth control until 7 days post dose. if female, two years post-menopausal, surgically sterile, and not pregnant or lactating * weights at least 45 kg * body mass index between 18 and 34 kg/m2 * meets criteria for moderate hepatic impairment defined by child-pugh method * subjects with normal hepatic function * agrees to practice highly effective birth control until 7 days post dose. if female, two years post-menopausal, surgically sterile, and not pregnant or lactating * weights at least 45 kg * body mass index between 18 and 34 kg/m2 * must have normal hepatic function defined by child-pugh method exclusion criteria: * subjects with moderate hepatic impairment * has history or presence of biliary obstruction or biliary disease, hepatic encephalopathy, advanced ascites, portal hypertension, esophageal /gastric variceal bleeding, hepatocellular carcinoma, previous liver transplantation. * has severe or moderate renal dysfunction * known to be human immunodeficiency virus (hiv) positive * has clinically significant history or presence of illness, malignancy or immunodeficiency * has had a blood transfusion or donated / lost 450 ml of blood or more within 60 days of study drug administrations or donated plasma within 7 days prior to clinical check-in * has history of alcoholism or drug/chemical/substance abuse within past 2 years * subjects with normal hepatic function * has severe or moderate renal dysfunction * known to be human immunodeficiency virus (hiv) positive * has clinically significant history or presence of illness, malignancy or immunodeficiency * has had a blood transfusion or donated / lost 450 ml of blood or more within 60 days of study drug administrations or donated plasma within 7 days prior to clinical check-in * has history of alcoholism or drug/chemical/substance abuse within past 2 years

Keywords: liver disease asp1941
a study to compare two forms of ly2608204 in healthy people

Conditions: Healthy Volunteers

Summary: the purpose of this study is to compare 2 formulations of the study drug (ly2608204) in terms of how much gets into the blood stream and how long it takes the body to get rid of it. information about any side effects that may occur will also be collected.


Eligibility criteria:
inclusion criteria: * must be a healthy male or a female who cannot become pregnant * must have body mass index (bmi) of 18.5 to 32 kg/m², inclusive * blood pressure as well as blood and urine laboratory test results must be acceptable for the study * the veins must be suitable for easy blood collection * must be willing to be available for the whole study and be willing to follow study procedures * must have given written informed consent exclusion criteria: * were in another new drug or medical research study in the last 30 days * have participated in this study or any other study with ly2608204 before * have taken drugs similar to ly2608204 (glucokinase activators) before and was found to be allergic to the drug * have drug allergy to more than 3 types of medications given by injection * currently have or used to have health problems or laboratory test results that in the opinion of the doctor, could interfere with understanding the results of this study * electrocardiogram (ecg) readings are not suitable for the study * are infected with hepatitis b * are infected with human immunodeficiency disease virus (hiv) * are using or intend to use over-the-counter medication or prescription medications within 14 days, from the start of the first study dosing until end of study * are unwilling to follow dietary restrictions/requirements for the study including (i) refrain from consuming foods or beverages containing grapefruit pomelo, star fruit, or seville orange within 14 days of the start of the study drug dosing until collection of the last blood sample for drug assay; (ii) consume only the meals provided during dosing day at the clinical research unit (cru) * have a regular alcohol intake greater than 21 units per week (males) and 14 units per week (females) or are not willing to abstain from alcohol while in the research unit * smoke more than 10 cigarettes per day or are not willing to abstain from smoking while at the clinic * have a history of drug or alcohol abuse * have donated 450 milliliter (ml) or more of blood in the last 3 months (this is about the same as the usual volume given in a blood donation) * the study doctor thinks the subject should not participate for any other reasons

Keywords: diabetes mellitus, type 2
non-pharmacologic interventions to relief pain in healthy newborns submitted to vaccination to hepatitis b

Conditions: Pain; Analgesia

Summary: acute procedural pain in neonates may be alleviated by non-pharmacological procedures. this study objective is to test the efficacy regarding pain attenuation of 3 interventions (skin-to-skin contact versus glucose 25% versus skin to skin associated to glucose 25) versus control in healthy newborn infants submitted to intra-muscular vaccination for hepatitis b at 48-72 hours of life.


Eligibility criteria:
inclusion criteria: * written informed consent. * gestational age of 37 0/7 to 41 6/7 weeks. * patients cared in rooming-in, with post-natal age of 12 to 72 hours of life. * adequate for gestational age and healthy infants. * no other painful stimuli before study except for vitamine k injection soon after birth. * interval from last feeding between 30 and 60 minutes. exclusion criteria: * mothers that used opioid at gestation labor or birth. * delivery under general anesthesia. * apgar score less than seven in the 1st or 5th minute of life. * neonates that received any venous, arterial, capillary or spinal puncture. * any congenital malformation or cns abnormality.

Keywords: pain newborn infant analgesia
monitoring of oral human papillomavirus infection (hpv) in hpv-positive oropharyngeal squamous cell carcinoma (opscc)

Conditions: Carcinoma, Squamous Cell; Head and Neck Neoplasms; Oropharyngeal Neoplasms

Summary: the purpose of this research study is to determine whether and when patients with human papilloma virus positive squamous cell cancer of the oropharynx treated with radiation and chemotherapy clear their human papilloma virus infection.


Eligibility criteria:
inclusion criteria: 1. ≥ 18 years of age (no upper age limit) 2. anyt, anyn, m0 squamous cell carcinoma of the oropharynx 3. biopsy proven squamous cell carcinoma that is hpv positive via standard pathological assessment of tumor tissues in pathology department at the treating institution 4. scheduled for definitive crt as primary treatment of their oropharynx cancer exclusion criteria: 1. prior history of radiation therapy to the head and neck 2. prior history of mucosal head and neck cancer. 3. not willing or able to comply with study specific procedures

Keywords: human papilloma virus oropharynx oropharyngeal squamous cell carcinoma squamous cell carcinoma radiation therapy chemotherapy
pain smart: shared medical appointments to refocus treatment

Conditions: Chronic Pain

Summary: the proposed study will test whether a shared medical appointment for veterans with chronic pain is feasible and acceptable to veteran patients and their providers. the shared medical appointment, called pain smart (shared medical appointments to refocus treatment), is a brief, one-visit shared medical appointment where providers in primary care and a behavioral health specialist (e.g., a psychologist) meet with a group of patients with chronic pain. the overall goal of pain smart is to improve pain care for veterans. veterans will be randomized in equal numbers to either attend a pain smart visit or to receive educational information in the mail. the primary outcome of this pilot study is whether or not the shared medical appointment is feasible and acceptable to patients and providers.

objectives: the primary purpose of this study is to understand the feasibility and acceptability of a shared medical appointment for patients with chronic pain called pain smart (shared medical appointments to refocus treatment). intervention: the overall goal of pain smart is to increase the use of evidenced-based pain management strategies including pain self-management and other non-pharmacological pain management approaches. pain smart is a brief one-visit shared medical appointment delivered by primary care team members (e.g., primary care providers) and a behavioral health specialist (e.g., a clinical health psychologist). pain smart uses motivational interviewing to enhance effective and mutually rewarding communication among providers and veterans to increase pain self-management, including uptake of non-pharmacological approaches to pain management, to ultimately enhance quality of care and veteran functioning. study participants: primary care providers/staff will be recruited to participate in pain smart visits as shared medical appointment facilitators. additionally, up to 80 veterans with chronic pain will be recruited. research design: this study is a randomized pilot study in which veteran participants are randomized to attend pain smart or to a minimally enhanced usual care condition (i.e., receive an educational brochure via mail). veteran participants will be randomized in equal numbers to both conditions. data collected from veteran participants at baseline and three months following baseline; data will also be collected from primary care participants regarding their experience with pain smart. data collection will include quantitative measures (e.g., information regarding pain and pain management approaches used) and qualitative measures (e.g., interviews about participants' experiences with pain smart).

Eligibility criteria:
veteran inclusion criteria: * receives primary care from provider at va connecticut who is participating in the study * prescribed an opioid for chronic pain veteran exclusion criteria: * active suicidal ideation * psychotic disorder * active consult to opioid reassessment clinic at va connecticut

Keywords: chronic pain shared medical appointment veterans
carbon dioxide laser vs. electrocoagulation for the therapy of condyloma

Conditions: Condylomata Acuminata

Summary: in a randomized clinical trial of 114 women undergoing treatment for condyloma acuminata, two surgical methods, the carbon dioxide laser ablation and the excision by electrocoagulation, will be compared. the primary outcome of the study is the cosmetic result judged by the patient 6 weeks after treatment using a 11-step visual analogue scale (vas), secondary outcomes are intervention time, operative complications, subjects and users satisfaction, postoperative pain and recurrence of genital warts.


Eligibility criteria:
inclusion criteria: * informed consent * women with anogenital affection of condyloma acuminata exclusion criteria: * significant language barrier * pregnancy * unwillingness to participate * the use of blood thinner or known coagulation disorder * the use of immunosuppressive medicament * hiv-infection * malignant diseases * local therapy within 8 weeks before treatment * wound healing disorder

Keywords: sexually transmitted disease genital warts venereal warts
[18f] dihydro-testosterone pet and mr imaging in patients with localized prostate cancer

Conditions: Prostate Cancer; Localized Prostate Cancer

Summary: the purpose of this study is to test the ability of a new pet scan radiotracer, called fdht (stands for \[18f\] dihydro-testosterone), to better find and monitor prostate cancer. radiotracers are a type of drug that carries small amounts of radioactivity that can be seen by the pet scanner. fdht is a radiotracer that looks for a protein which is present in almost all prostate cancer cells. the investigators want to find out if we can find and monitor changes in cancer using a fdht pet scan.


Eligibility criteria:
inclusion criteria: * male aged 21 years or older and below 80 years of age. * signed written informed consent and willingness to comply with protocol requirements. * histologically confirmed diagnosis of prostate cancer. * staging imaging workup including a baseline mri of the prostate and pelvis performed at mskcc. * baseline imaging to rule out distant metastatic disease (99mtc bone scan, naf pet, total body mri, or ct chest/abdomen/pelvis) * karnofsky performance status ≥ 70 * clinical criteria required to be eligible: a. one of the following i.pre-treatment psa ≥10 ng/dl, or ii. clinical t-stage assessed by digital rectal exam of ≥t2a, or ii . radiographic ≥t3a on mri, or iv. gleason score of ≥3+4=7 c. visible intraprostatic tumor foci ≥1 cm in largest dimension on t2-weighted images based on initial pre-treatment mri * physician recommendation of adt. exclusion criteria: * metastatic disease on standard staging imaging (beyond regional lymph node involvement). o absence of metastatic disease (beyond regional lymph node involvement) as defined by a negative bone scan, naf pet, ct chest/abdomen/pelvis, or total body mri. * prior treatment of the prostate gland for malignant conditions (surgery, cryotherapy, radiotherapy, or photodynamic therapy). * physician prescription of androgen receptor antagonist therapy (examples: bicalutamide, flutamide, or enzalutamide) during time of protocol scans. o note: adt consists of chemical castration (i.e. degarelix) to remove endogenous dht. androgen receptor antagonists will bind to the androgen receptor and inhibit fdht from binding. * patients receiving testosterone supplementation . * any contraindication to baseline mri based on departmental mr questionnaire, or inability to cooperate for an mri scan. * history of allergic reactions attributed to compounds of similar chemical or biologic composition to fdht. * hepatic laboratory values: 1. bilirubin \>1.5 x uln (institutional upper limits of normal) 2. ast/alt \>2.5 x uln 3. albumin \<2 g/dl * creatinine \>2.5 mg/dl * calcium \>11 mg/dl * other serious illness(es) which might preclude completion of this study or interfere with determination of causality of any adverse effects experienced in this study.

Keywords: [18f] dihydro-testosterone pet scan mri 14-185
erector spinae plane block for congenital hip dislocation surgery

Conditions: Congenital Hip Dysplasia

Summary: developmental dysplasia of the hip (ddh) is one of the major disorder of the pediatric population with an incidence of 3 to 5 per 1000 children. open surgical reduction of congenital hip dislocation (chd) is typically performed after an ineffective closed reduction or older than 18 months. multiple femoral or pelvic osteotomies and tenotomies are performed during this surgical treatment and cause severe postoperative pain. the aim of this study was to evaluate the analgesic effect of ultrasound guided erector spinae plane block (esp) in pediatric patients undergoing chd surgery.


Eligibility criteria:
inclusion criteria: * american society of anesthesiologist's physiologic state i-ii patients undergoing hip dislocation surgery exclusion criteria: * chronic pain * bleeding disorders * renal or hepatic insufficiency * patients on chronic non-steroidal anti-inflammatory medications * emergency cases * incomplete patient forms * infection of the skin at the site of needle puncture area * patients with known allergies to any of the study drugs * asa iii-iv

Keywords: postoperative analgesia ultrasound guided erector spinae plane block
exercise for advanced prostate cancer: a multicomponent feasibility trial

Conditions: Prostate Cancer Metastatic; Castration-resistant Prostate Cancer

Summary: this feasibility study will investigate whether men with metastatic prostate cancer can take part in and progress through a home-based exercise program. this study will evaluate the effects of exercise on a range of disease and treatment-related outcomes.

this 12 week multicomponent, tailored, progressive program will consist of both moderate intensity walking and strengthening exercises at home. this single centre, single arm study will incorporate a behavioural change consultation at baseline and weekly behavioural support throughout. this study will follow-up patients at 24 weeks to determine exercise maintenance. outcome measures will be completed at baseline, 12 and 24 weeks. a qualitative evaluation will be conducted after the 24 week follow-up to determine impact, patient experience and measures that might assist in refining the program.

Eligibility criteria:
inclusion criteria: * histologically documented adenocarcinoma of the prostate with progressive systemic metastatic disease despite castrate levels of testosterone (\<50ng/dl). * at enrolment, patients must have demonstrated progressive disease since the most recent change in therapy. * patients must be on adt with a gnrh agonist/antagonist or prior bilateral orchiectomy. all patients must be on adt during the study period. * ≥ 4 weeks since last surgery and fully recovered. * no known contraindications to moderate intensity exercise such as (but not limited to) brain metastases, acute congestive heart failure, unstable angina, serious or non-healing wound, peripheral neuropathy greater than or equal to grade 3. recent myocardial infarction. * age ≥ 18 years. * ecog performance status 0-2. * medical clearance by treating clinician. exclusion criteria: * men currently exceeding acsm recommended exercise guidelines (150 mins of moderate and/or 60 mins of high intensity exercise per week). * men with brain metastases. * men with a currently active second malignancy other than non-melanoma skin cancer. * congestive heart failure or recent serious cardiovascular event. * chest pain brought on by physical activity.

Keywords: exercise metastatic castrate-resistant prostate cancer
the effect of electrode implantation for deep brain stimulation (dbs) on brain function using single photon emission computed tomography (spect) with technetium-99m-ethyl cysteinatedimer (tc-ecd)

Conditions: Parkinson's Disease; Deep Brain Stimulation

Summary: the goal of this study is to explore the effect of subthalamic nucleus (stn)-dbs surgery and stimulation in pd (parkinson's disease) patients on regional cerebral blood (cbf) flow during cognitive task performance or at rest.

in this study subjects undergo spect scans for cbf mapping. pd patients before the surgery and healthy controls undergo two scans. pd patients after the surgery undergo four scans. pd patients who undergo two scans before the surgery, undergo only two scans after the surgery. uptake of tc-ecd, a cbf radiotracer, is done in the following conditions: * for pd patients before the surgery - during the performance of the semantic verbal fluency task or at rest (total of 2 scans). * for pd patients after the surgery- during the performance of the semantic verbal fluency task or at rest, either at on-stimulation or off-stimulation condition (total of 4 scans). the stimulator is turned off by the neurologist for 10 min. * pd patients before and after the surgery- during performance of the semantic verbal fluency task or at rest before the surgery and during performance of the semantic verbal fluency task or at rest after the surgery only at off-stimulation condition (total of 4 scans). * healthy controls - during the performance of the semantic verbal fluency task or at rest (total of 2 scans). following the tc-ecd injection, the subjects are scanned by irix spect camera for 15min. scans are analyzed and the regional cbf is measured using imaging software. statistical analysis is done to discover the effect of the surgery, stimulation and the disease on blood flow at rest and during task performance. in addition, differences between groups in number of words produced during the task are also statistically analyzed.

Eligibility criteria:
inclusion criteria: * progressive idiopathic pd * for control group - age-matched to study groups exclusion criteria: * progressive dementia or other psychiatric disorders * other neurological conditions * other physical disease * intolerance of "off stimulation" state * involuntary head motions * hearing deficits

Keywords: pd dbs