Kornimate/medical-research-clean huggingface dataset:
in-us-276-1340: pre-exposure prophylaxis to prevent hiv acquisition in us women: a demonstration project

Conditions: PrEP Adherence Monitoring

Summary: the overall aim of this study is to assess attitudes toward prep, feasibility of truvada prep procurement through the established access procedures, and adherence to truvada prep among us women at risk for hiv acquisition.

study design: this is a 24 week prospective pilot study assessing attitudes toward and feasibility of using truvada prep in a population of women at risk for hiv acquisition.at this site 31 hiv- uninfected women desiring prep will be enrolled at each site (confirm number). we will have to consent about 50 women which includes screen failures.the study will assess attitudes towards and adherence to prep with questionnaires at weeks 12 and 24. tenofovir levels procured at week 12 and 24 week of prep will be used to assess adherence to prep. primary objectives: 1. describe attitudes toward prep among a population of women at risk for hiv acquisition, living in hiv prevalent areas. 2. assess feasibility of truvada procurement through the established gilead access program 3. evaluate adherence at week 12 and week 24 using dried blood spots secondary objective: 1. describe hiv incidence 2. describe associations of positive and negative attitudes toward prep with acceptance of prep and subsequent adherence 3. assess adherence at weeks 12 and 24 4. evaluate the relationship between prep adherence and sexual activity 5. compare geographic areas with respect to prep attitudes 6. mentor junior investigators at each site.

Eligibility criteria:
inclusion criteria: * 18 - 64 years old * able to give consent * "at risk" for hiv as defined by any of the following: 1. unprotected sex (in past 6 months) with 1 or more men of unknown hiv status 2. evaluated for an sti within 6 months prior to screening 3. sex in last 6 months with an hiv-infected partner 4. idu with report of using previously used or shared needles in past 6 months or has been in a methadone, buprenorphine, or suboxone treatment program in past 6 months or engaging in high-risk sexual behaviors 5. individuals engaging in transactional sex (i.e sex for money, drugs, or housing) 6. infrequently uses condoms during sex with 1 or more partners of unknown hiv status who are known to be at substantial risk of hiv infection (idu or bisexual male partner) * crcl ≥ 60 ml/min * hiv- uninfected women desiring prep exclusion criteria: * active alcohol or drug use or dependence which may interfere with adherence to study requirements * hiv-infected at screening or enrollment * estimated crcl \< 60 ml/min * past participation in an hiv vaccine study * positive hepatitis b surface antigen test * underlying medical condition with survival unlikely during follow-up period * any condition that in the opinion of study staff would make participation in the study unsafe or interfere with achieving study objectives * pregnant or breast feeding * actively trying to achieve pregnancy

Keywords: hiv truvada
preference comparisons for algorithms to hear speech

Conditions: Hearing Loss

Summary: twenty people with hearing impairment will be tested and fitted binaurally with hearing aids. during a real-world listening situation, each participant will be asked to compare one program with a novel algorithm to one with a standard microphone configuration. they will provide ratings on a range of outcome measures including overall preference and awareness of background noise. overall and specific preferences for the different programs/algorithms will be determined by their subjective responses to determine if there is a significant difference between the two programs.

people with hearing loss/impairment often have difficulty not only hearing certain sounds (e.g., environmental and speech sounds) but also listening in certain situations such as those where noise competes with speech. this is a common situation in people's real life conversations and one which different hearing instrument algorithms could facilitate. this study will investigate the listening preferences of people with hearing impairment while wearing hearing aids. they will listen to speech in a situation which is commonly reported as difficult for people who wear hearing aids. participants will wear one set of hearing aids set to their hearing loss with two programs providing these different algorithms. by having the participants toggle (with a remote control) back and forth between algorithms designed for these real-life difficult listening situations, they can rate their preferences and listening experiences. of particular interest, in addition to overall preference, are ratings of the background noise, listening effort and annoyance of artefacts.

Eligibility criteria:
inclusion criteria: subjects fulfilling all of the following inclusion criteria are eligible for the investigation: * including adults with sensorineural mild to moderate-severe hearing loss * hearing aid experience (greater than 6 months) * who are able to complete the task in english. * language: can speak and understand english fluently hearing loss within the fitting ranges of the investigational products. * healthy outer ear. * ability to understand instructions. * ability to describe listening experiences. * ability to fill out questionnaires. * informed consent as documented by signature. exclusion criteria: - the presence of any one of the following exclusion criteria will lead to the exclusion of the subject: * contraindications to the md in this study (e.g. known hypersensitivity or allergy to the investigational product). * limited mobility and not able to attend to appointments or not able to go in a car. * reported symptoms of vertigo and dizziness by subject. * severe tinnitus
brain energy activation with ketones to prevent alzheimer's disease

Conditions: MCI

Summary: a six month randomized controlled intervention with an exogenous ketone salt (eks) supplement in mild cognitive impairment. participants will receive 15 g of the supplement twice daily (equivalent to 24 g/day of eks). outcomes: brain energy metabolism, cognition, plasma biomarkers, brain imaging (volumetric, functional, structural) and quality of life will be analyzed before and after the intervention.


Eligibility criteria:
inclusion criteria: * the participant must answer yes to the question ''do you think your memory is not as good as it was?'' * have a moca score between 20/30 and 26/30 * have a qaf score of less than 9/30 * understand, read and talk french * having good visual and hearing acuity exclusion criteria: * major cognitive decline or neurodegenerative disease. * already consuming a daily medium chain triglyceride or ketone supplement. * soy, milk, gluten or allergy to the study product * controlled or uncontrolled diabetes * uncontrolled chronic disease * vitamin b12 deficit * clinical anomaly in the blood chemistry profile * qsp-9 score over 19/27 * taking an anti-cholinergic drugs * recent change in medication * active cancer in the last 2 years * general anesthesia in the last 6 months * history of alcohol abuse or dependence in the last 2 years * participation in other interventional or pet research project * unable to undergo an mri or pet scan * history of kidney stones or hypercalcemia * history of cardiovascular events or insufficiency * renal failure and / or creatinine \ 110 umol for men and \ 92 umol for women or if the gfr (glomerular filtration rate) \<60 ml / min / 1.73 m2 * chronic disease of the digestive system or intestinal malabsorption (celiac disease, chronic pancreatitis, crohn's disease, etc.) * body mass index \<20 or voluntary weight loss of more than 5% in the last 6 months.
resting heart rate monitoring for optimized treatment and surveillance of hyperthyroidism

Conditions: Hyperthyroidism; Graves Disease

Summary: the investigators want to investigate if a continuous heart rate monitoring with a wrist worn fitnesstracker can be useful in the treatment and surveillance of patients suffering from graves' disease.the aim of our research project is two-fold: first, to evaluate the use of continuous heart rate monitoring as a potential substitute for hormone measurements during treatment of hyperthyroidism. second, to use continuous heart rate monitoring as a tool for early detection of relapse after discontinuation of antithyroid drugs.


Eligibility criteria:
inclusion criteria: all participants: * bmi 17 to 35 kg/m2 * diagnosis of graves' disease (matching one of the following criteria: elevated trab and/or ultrasonography and functional imaging consistent with graves' disease) * in possession of a smart phone * able to use a wearable device and willing to regularly upload their biometric data * informed consent as documented by signature (appendix informed consent form) group "treatment": * tsh \< 0.2 miu/l and * ft4 \> 25 pm or ft3 \> 8 pm * atd planned, additional treatment with propranolol allowed group "surveillance": * tsh within the reference range between 0.3 and 4.5 mlu/l * cessation of atd is planned within the next 2-4 weeks exclusion criteria: * chronic treatment with beta blocker or verapamil-type calcium antagonist for other reason than symptomatic treatment of hyperthyroidism (propranolol) * treatment with amiodarone * pacemaker with continuous stimulation. * severe concomitant diseases: chronic heart failure, liver cirrhosis, kidney failure, active cancer * abuse of alcohol or illicit drugs * allergic to nickel or silicone * inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant

Keywords: heart rate; pulse rate
recombinant endostatin combined with vinorelbine and cisplatin in patients with advanced non-small cell lung cancer

Conditions: Advanced Non-small Cell Lung Cancer

Summary: the main object of this trial is to offer treatment of recombinant endostatin ( sulijia) combined with vinorelbine and cisplatin (np) plus maintenance therapy with sulijia for advanced non-small cell lung cancer, expecting to improve progression free survival (pfs) , disease control rate(dcr) , objective response rate(orr) and overall survival (os) compared with chemotherapy alone, and evaluate the efficacy and safety of sulijia.

recombinant endostatin injection sulijia is a new type of recombinant protein drugs inhibiting tumor angiogenesis developed by a group of chinese scientists and clinician. it is expressed in e. coli which consists of 184 amino acids. it appears to be better than np chemotherapy alone in terms of efficacy in phase i/ii trials for advanced nsclc. in this study, a randomized, double-blind, placebo plus np as control, multi-center phase iii trial was designed to evaluate the safety and efficacy of sulijia plus np in the treatment of advanced nsclc patients. pfs (progress free survival) is the primary end-point with os (overall survival), orr (objective response), dcr (disease control rate) and safety as the secondary end-point. a total of 560 patients have been recruited.

Eligibility criteria:
inclusion criteria: 1. male and female aged 18 to 70 years old; 2. patients with histological confirmed stage iv nsclc; 3. according to the standard of recist1.1, they should have at least one of accurately measurable lesions with the largest diameter \>=10mm by spiral ct, pet-ct, with the largest diameter \>=20mm by ordinary ct and mri; 4. general condition ecog performance scale (ps) 0-1; 5. life expectancy of more than 3 months; 6. no major organ dysfunction and laboratory indicators should meet the following requirements: absolute neutrophil count \> 1.5\*10\^9/l, platelet count\> 90\*10\^9/l, hemoglobin\> 9g/dl; liver function: serum bilirubin was less than 2\* maximum normal value; alt and ast were less than 2.5\*maximum normal value; bun, cr within 80% of normal range; 7. patients could understand the circumstances of this study and those who have signed the informed consent form. exclusion criteria: 1. receive the treatment of other experimental trials in the same period; on the medication of other anticancer drugs at the same time; 2. patients who have uncontrolled brain metastasis; 3. suffered from any other malignant tumors in the five years except for complete cure of cervical carcinoma in situ, basal cell cancer; 4. pregnant or lactating women; 5. severe infected patients; 6. patients who have serious cardiovascular disease such as coronary heart disease, unstable cardiac angina and high blood pressure; 7. patients who have vein thrombus; 8. patients who have psychiatric illness; 9. patients who are allergic to e. coli preparation; 10. researchers believe that those who do not fit.

Keywords: non-small cell lung cancer sulijia recombinant endostatin vinorelbine cisplatin
eszopiclone co-administered with escitalopram for insomnia in elderly adults with major depressive disorder

Conditions: Insomnia

Summary: research has established the incidence of insomnia increases with age and the possible causes contributing to sleep problems in the elderly are still being explored and debated. older adults use a disproportionately large share of sleep aids with non-prescription sleep aid use having increased over the past decade. this study is a double blind safety and effectiveness trial examining the response of eszopiclone co-administered with escitalopram for the treatment of insomnia symptoms in geriatric depressed adults with insomnia symptoms.

this is a double-blind, randomized, placebo-controlled, parallel-group study. there are two groups of subjects with major depressive disorder and insomnia symptoms randomized to treatment either with eszopicone 2mg or placebo daily at bedtime for 14 weeks beginning at visit 2. also, all subjects receive open label treatment with escitalopram 10 or 20mg daily in the morning. safety and efficacy is evaluated as well as rating scales and patient sleep diaries.

Eligibility criteria:
inclusion criteria: * diagnosis of mdd, hamd score 20 or greater at screening and baseline, total sleep time less than 6 hours at screening and baseline, isi 15 or greater at screening and baseline exclusion criteria: * may not use any other psychoactive drugs/psychotropics during study, may not have any type of dementia, may not have any significant/unstable medical problems, no nightshift work permitted, no current seizure disorders/head injuries

Keywords: insomnia major depression geriatric
evaluation of group cbt programme with breast cancer patients

Conditions: Breast Cancer

Summary: the purpose of this study is to examine whether a group cbt intervention is effective in reducing psychological distress in women with primary breast cancer.

the diagnosis and treatment of cancer is associated with high levels of psychological distress, which can be long-term in duration. the end of adjuvant therapy can be a time which patients find anxiety provoking; as concerns of recurrence and how to return to life after treatment often arise at this juncture. cognitive behaviour therapy has demonstrated efficacy in reducing anxiety and depression in people with cancer on a 1:1 basis. the cbt model has been shown to be significantly more beneficial than supportive counselling. therapy delivered in groups is considered desirable because of its cost effectiveness, and its potential to confer additional benefits in terms of peer support, reduced isolation and modelling of adaptive strategies by other group members. no studies have looked at the changes in participants health beliefs and beliefs about their ability to copy (self-efficacy) with stress and tolerance of uncertainty following group cbt and the relationship with psychological distress. the aim of this study is to evaluate a gcbt programme intervention against a waiting list control and to examine its effects on health beliefs, self-efficacy, coping, tolerance of uncertainty and psychological distress in women with early diagnosed breast cancer.

Eligibility criteria:
inclusion criteria: * female * primary breast cancer * post adjuvant treatment exclusion criteria: * women with metastatic disease * severe cognitive impairment (will not be able to obtain consent or participant in group intervention) * inability to complete a questionnaire

Keywords: breast cancer cognitive behaviour therapy psychological
pre-emptive analgesia with qutenza in lower limb amputation

Conditions: Neuropathic Pain; Lower Limb Amputation

Summary: neuropathic (nerve pain) following amputation of a limb is very common, affecting 60-80% of patients (sherman et al, 1984). it can prolong their recovery making it difficult to fit protheses and mobilise. current treatment options are limited and existing painkillers have significant side effects. nevertheless there is some evidence that pre-emptive analgesia (pain relief provided prior to the surgery) has additional benefits after the surgery (ypsilantis \& tang, 2010) qutenza (topical capsaicin 8%)is a novel analgesic agent which is applied directly onto the skin. it works by desensitising to pain receptors in the skin (nolano et al., 1999) and has been shown to be effective in reducing neuropathic pain in other conditions (backonja et al., 2008) we propose to evaluate the use of qutenza for pre-emptive analgesia in patients undergoing amputation of a limb. this is a small, pilot, randomised controlled study of 30 patients undergoing lower limb amputation who will have qutenza or active control applied prior to surgery. they will be followed up for 12 weeks post-operatively with regular assessment of pain scores, quality of life and wound healing.


Eligibility criteria:
inclusion criteria: * all adult patients \>18 years old undergoing lower limb amputation exclusion criteria: traumatic amputation severe active sepsis in non-viable limb illness necessitating urgent surgery \ 200) proven cardiac event during the preceding 3 months women who are pregnant or breast feeding lack of capacity or inability to provide informed consent declines participation in the study

Keywords: neuropathic pain lower limb amputation pre-emptive analgesia
high dose rate interstitial brachytherapy with three dimensional printing template for recurrent gynecologic tumors

Conditions: Cervical Cancer

Summary: this is a single-center study.eligible patients will have histologically proven pelvic recurrence of cervical cancer after radiotherapy .

the results of treatment, examination and follow-up of patients with recurrent cervical cancer after radiotherapy who recieved imaging guided three dimensional printing personalized template assisted with 192ir high dose rate interorganizational braided therapy were statistically analyzed .

Eligibility criteria:
inclusion criteria: * patients with histologically confirmed pelvic recurrence of cervical cancer. * age ≥ 18 years and ≤ 75 years. * previous accept pelvic radiotherapy; * karnofsky ≥60； * patients reject or cannot tolerate surgery; * received 192ir high dose rate intertissue salvage therapy; * ultrasound guidance or computed tomography guidance; * regular review and follow-up. exclusion criteria: * patients participated in clinical trials of other drugs within four weeks; * the patient had a previous history of bleeding, and any bleeding event with severity rating of ctcae5.0 or above occurred within 4 weeks prior to screening; * there are any puncture taboos. * patients with severe cardiovascular and cerebrovascular diseases. * unable to treat as planned. * patients lack major indicators and cannot participate in post-treatment review and follow-up.
vaccine therapy of prostate cancer patients with recombinant soluble prostate-specific membrane antigen (rs-psma) plus the immunological adjuvant alhydrogel

Conditions: Prostate Cancer

Summary: the purpose of this research is to help us study a vaccine treatment for patients with prostate cancer. a vaccine is a medicine that teaches the body to destroy harmful infections and other diseases, such as cancer. your immune system is made up of many different types of cells which fight infection and disease in your body. a vaccine may stimulate the immune system to destroy the cancer cells. it may also help to slow the growth of the cancer. the vaccine is a solution given as an injection into or under the skin. it is made up of several parts. the first part is psma, a protein present in many cancers, especially prostate cancer. it is referred to as rspsma when made in a laboratory for this study and is mixed with a material called alhydrogel® (aluminum hydroxide suspension) which helps the immune system to make more cancer-fighting cells.


Eligibility criteria:
inclusion criteria: * non-castrate metastatic patients must have biochemically progressive disease as defined by serial changes in psa (with a serum testosterone \> or = to 180 ng/ml)following definitive primary therapy such as prostatectomy or radiation. castrate metastatic patients must have biochemically progressive disease in the absence of radiographic evidence of disease progression with rising psa values despite castrate (\<50 ng/ml) levels of testosterone following an adequate course of hormonal therapy. an adequate course of hormonal therapy is treatment with an lh-rh analog (with or without an anti-androgen) or orchiectomy. * prostate cancer must be histologically confirmed by the department of pathology at mskcc. * karnofsky performance status \>70%. * patients must have adequate organ function as defined by: * wbc \> or = to 3000/mm3, neutrophils \> or = to1000/mm3, platelet count \> or = to l00,000 mm3 * bilirubin \<2.0 mg/dl * alkaline phosphatase and sgot \<3.0 times the upper limit of normal * creatinine \< or = to 2.0 mg/dl * hemoglobin \>9.0 g/dl * alt \<2.5 times the upper limit of normal * patients must be at least 18 years of age * expected survival must be \>6 months * patients must sign informed consent. * non-castrate metastatic patients must have a serum testosterone \>180 ng/ml. exclusion criteria: * radiographic evidence of disease progression. * clinically significant cardiac disease (new york heart association class iii/iv or severe debilitating pulmonary disease). * active cns or epidural tumor. * an infection requiring antibiotic treatment. * lymphopenia defined by lymphocytes \<1000/mm3. * cancer related pain requiring the use of opioid containing analgesics. * positive stool guaiac, excluding hemorrhoids or documented radiation-induced proctitis. * concurrent treatment with nutritional or herbal supplements (e.g., pc spes or similar agents) which could potentially confound the interpretation of study results. * history of an active secondary malignancy except for non-melanoma skin cancer.

Keywords: prostate alhydrogel rs-psma