Kornimate/medical-research-clean huggingface dataset:
clinical study of time optimizing of endoscopic photodynamic therapy on esophageal and/or gastric cardiac cancer

Conditions: Stage I Esophageal Adenocarcinoma; Stage II Esophageal Adenocarcinoma; Stage III Esophageal Adenocarcinoma; Stage I Esophageal Squamous Cell Carcinoma; Stage II Esophageal Squamous Cell Carcinoma; Stage III Esophageal Squamous Cell Carcinoma

Summary: the therapy of photofrin pdt was effective in improving life quality of patients with advanced esophageal and/or gastric cardiac cancer and the time optimizing for employing laser irradiation was of great importance.the purpose of this study is to evaluate the clinical efficacy and adverse effects of photodynamic therapy (pdt) on esophageal and/or gastric cardiac cancer during different time after inject photofrin.

the investigators plan to recruit the patients who were pathologically confirmed with esophageal squamous cell carcinoma or gastric cardia adenocarcinoma from the oct.2015. the patients will be divided into two groups. group 1: following intravenous administration of photofrin at dose of 2 mg/kg.b.w. as the photosensitizer, 630 nm laser irradiation (diomed) with 400 mw/cm was applied on each part of tumor for 750 seconds through cylinder diffusing quartz fibers localizing in the biopsy channel of a flexible endoscope at 24th. group 2: following intravenous administration of photofrin at dose of 2 mg/kg.b.w. as the photosensitizer, 630 nm laser irradiation (diomed) with 400 mw/cm was applied on each part of tumor for 750 seconds through cylinder diffusing quartz fibers localizing in the biopsy channel of a flexible endoscope at 48th.

Eligibility criteria:
inclusion criteria: * in the esophagus, patients with severe dysplasia and carcinoma in situ * the patients have not received the surgery or chemo-radiotherapy. * hb≥80g/l, absolute neutrophil count ≥1.5×109/l, plt≥90×109/l, alt、ast≤2.5\*n,cr≤1.5\*n. * performance status score 0-2 exclusion criteria: * pregnant, lactating women * history of organ transplantation * the peripheral nervous system disorders * severe infection * oral capecitabine who have difficulty with,such as dysphagia,the activities of digestive ulcer, gastrointestinal bleeding * severe chronic diseases, such as, hepatopathy, nephropathy, respiratory disease,high blood pressure, diabetes. * other malignant tumor in recent 5 years.
prediction of acute postoperative pain and analgesic consumption

Conditions: Postoperative Pain

Summary: pain is an expected part of surgical recovery but effective pain management remains challenging. the high variability in postoperative pain experience and analgesic treatment response between patients is part of the challenge. few studies have yet combined preoperative assessment of responses to experimental pain with measurements of cognitive and emotional processes in the prediction of postoperative pain. we hypothesize, that preoperative evoked brain potentials (using standard electroencephalographic brain imaging), endogenous pain inhibition capacity (conditioned pain modulation), responses to pressure/thermal pain stimulation, and/or situational pain-related catastrophic thinking are useful clinical predictors of postoperative pain and analgesic consumption.

preselected preoperative predictor variables/individual patient characteristics include the following: * evoked brain potentials (using standard electroencephalographic brain imaging) * capacity of descending pain inhibition induced by a cold pressor test (2c in 120 sec) * pressure pain detection and tolerance thresholds in muscle (m.quadriceps) * pressure pain tolerance thresholds in bone (sternum and tibia) * heat pain tolerance threshold in skin (forearm) * responses to the situational and dispositional pain catastrophizing scale * response to the state-trait and anxiety inventory * response to the beck's depression inventory

Eligibility criteria:
inclusion criteria: * elective minimally invasive surgical correction of funnel chest (pectus excavatum * age ≥15 years. exclusion criteria: * previous thoracic surgical interventions * presence of diseases affecting the central and/or peripheral nervous system * presence of chronic pain conditions * inability to speak and/or understand danish * inability to understand and participate in the experimental pain session * presence of psychiatric disorders * history of frostbite in the non-dominant upper limb * presence of sores or cuts on non-dominant upper limb * presence of cardiovascular disease * history of fainting and/or seizures * presence of fractures of the non-dominant upper limb * presence of reynaud's phenomenon. secondary exclusions included: * insensitivity to experimental cold pressor pain * lack of epidural catheter placement * re-operation

Keywords: funnel chest (pectus excavatum)
sugammadex hypersensitivity study (study p06042)

Conditions: Hypersensitivity

Summary: this trial was conducted to study the potential for hypersensitivity symptoms at the time of initial exposure to sugammadex and upon repeat exposure, since it was unknown whether the frequency or severity of hypersensitivity symptoms may worsen at repeat exposure over a prolonged period. in total 450 participants (all healthy subjects) were to be randomized to receive one of three study treatments: three repeated doses of either sugammadex 4 mg/kg, sugammadex 16 mg/kg, or placebo. participants were to receive one dose of study treatment on day 8, day 36, and day 78 of the study in order to determine the safety of each treatment dose.

all subjects were to be admitted to the study center the day before each scheduled dose and were to leave the unit the morning of the day after each dose. in cases of suspected hypersensitivity symptoms, healthy subjects were to remain confined to the study center until all signs and symptoms regressed, the subject was stable, and the investigator considered it safe for the subject to leave the study center. four sites participated in this trial.

Eligibility criteria:
inclusion criteria: * 18-55 years of age * serum tryptase \<=11.4 mcg/l and fasting triglyceride levels within normal limits * safety laboratory tests and vital signs must have been within normal limits * screening electrocardiogram must have been clinically acceptable and parameters within normal limits * body mass index between 19 and 32 kg/m\^2 * females must have agreed to use contraceptives * other certain administrative criteria as described in the protocol exclusion criteria: * females who were pregnant or intending to become pregnant * subjects who would not be able to participate optimally in the study, in the opinion of the investigator * certain surgical or medical conditions, recent infections, or mental instability * positive test for certain drugs or history of alcohol or drug abuse * positive test for hepatitis b, hepatitis c, or human immunodeficiency virus (hiv) * blood donation in the past 60 days * a history of unexplained reaction or hypersensitivity reaction during previous surgery and/or anesthesia * history of anaphylaxis from any cause, suspected history of hypersensitivity to cyclodextrins, or multiple drug hypersensitivities * heavy smoker * received certain medications in the past * history of allergy, hypersensitivity, or intolerance to epinephrine at greater risk of developing adverse reactions after epinephrine administration * other certain administrative criteria as described in the protocol
feasibility and impact of malaria rapid diagnostic tests in the african retail sector

Conditions: Malaria

Summary: the purpose of this study is to assess the feasibility and impact of introducing subsidized malaria rapid diagnostic tests (rdts) into retail sector drug shops in uganda. this is a randomized controlled trial at the village level, taking place in 6 districts in eastern uganda. licensed drug shops in selected villages were trained in proper rdt storage, administration, interpretation and disposal and were given access to subsidized rdts for sale. this study explores whether drug shop owners--when given access to training and subsidized rdts--will choose to promote and sell rdts to customers and, if so, at what volume and what price. the investigators also explore whether shops will safely store, administer, interpret and dispose of rdts and to what extent they will use rdt results to guide treatment recommendations. finally, the study explores whether making rdts available for sale in local drug shops has a community level impact on diagnostic testing and appropriate treatment for malaria.


Eligibility criteria:
inclusion criteria: drug shops: * licensed and registered as a drug shop with the ugandan national drug authority households: * live in the village of participating drug shop * female household head is 18 or over exclusion criteria: drug shops: * drug shop not registered with ugandan national drug authority * female household head is under 18

Keywords: malaria diagnosis rapid diagnostic tests rdts private sector retail sector drug shops
clinical study of intermittent positive pressure breathing (ippb)

Conditions: Lung Diseases; Lung Diseases, Obstructive; Chronic Obstructive Pulmonary Disease

Summary: to evaluate the efficacy of long-term intermittent positive pressure breathing (ippb) treatment when used as an adjunct to the overall care of ambulatory outpatients with chronic obstructive pulmonary disease. the evaluation compared the use of ippb with use of a powered nebulizer.

background: intermittent positive pressure breathing may be a useful adjunct therapy for patients with chronic obstructive pulmonary disease. it is, however, quite expensive; moreover, in 1976 its treatment efficacy had not been determined. although the effectiveness of ippb had been previously studied, the influence of long-term treatment was not known for the following reasons: the individuals studied had been too few and were not randomly assigned to treatment groups, the patient groups were not homogeneous and their clinical and functional status were not well-documented, and precise descriptions of the manner in which ippb was administered were not recorded. based on these facts, a conference on the scientific basis of respiratory therapy, co-sponsored by the american thoracic society and the division of lung diseases, issued a recommendation to develop a controlled clinical study of ippb. contracts were awarded to five clinical centers and a data center in november 1976. planning of the trial ended in november 1977. recruitment began in april 1978 for the 985 individuals who took part in this trial and ended in october 1980. patients enrolled after march 31, 1980, were followed for 30 months instead of 36 months. follow-up was completed in may 1983. design narrative: randomized, fixed sample of 985 patients. eligible patients were assigned to a treatment group using intermittent positive pressure breathing or to a control group using a powered nebulizer for treatment 3-4 times a day. treatments continued for 3 years. endpoints related to quality of life and respiratory function and capability.

Eligibility criteria:
men and women, ages 30 to 74, who were ambulatory and had symptomatic chronic bronchitis or emphysema.
association between abdominal body composition, inflammation, and risk for cardiovascular disease (the mesa abd study)

Conditions: Cardiovascular Diseases; Obesity

Summary: obesity is a growing public health concern, with approximately 31% of americans considered obese. the link between abdominal obesity and cardiovascular disease (cvd) has been well established, but the effect of distinct types of abdominal fat tissue on cvd risk is not well known. the rate of obesity and the distribution of abdominal fat differ with age, sex, and ethnicity. these differences may have important implications for determining ethnic-specific relationships between abdominal body composition (abc), inflammation, and cvd events. this study will evaluate the association between measures of abdominal fat, cvd risk, and inflammation in terms of ethnicity-, sex-, and age-specific differences.

abdominal obesity is a serious condition and increases the risk for potentially life-threatening cardiovascular diseases (cvds). abdominal fat is made up of structurally and functionally different tissues, which include visceral fat, subcutaneous fat, and intramuscular fat. the distribution and levels of these fat tissues are highly variable among obese people, and the effects of abc differences on cardiovascular health are not well known. notably, the standard measure of body mass index cannot distinguish between different kinds or ratios of tissue types that make up body weight and, therefore, may not be the best measurement tool. determining the specific measures of these tissue types by computed tomography (ct) may provide better insight into the varied cvd risk seen among different ethnicities, sexes, and ages. this study will evaluate the association between volumetric measures of abc, cvd risk, and inflammation in terms of ethnicity-, sex-, and age-specific variables. this substudy will use data and specimens, including blood samples and ct scans, from participants in the multi-ethnic study of atherosclerosis (mesa) for abdominal aortic calcium (aac). stored blood samples will be used to perform assays for several measures of inflammation and to generate new data on biomarkers and subclinical cvd measures. the existing ct scans will be used to calculate five discrete volumetric measures of abc, which will include subcutaneous fat, visceral fat, intramuscular fat, the visceral fat to visceral cavity ratio, and the lean muscle to visceral fat ratio. there will be no study visits for this study. the study completion date listed in this record was obtained from the "completed date" entered in the query view report system (qvr).

Eligibility criteria:
inclusion criteria: * participant in the mesa study exclusion criteria: * history of cardiovascualar disease

Keywords: body composition abdomen atherosclerosis
an observational study on predicting the efficacy of immunotherapy for nsclc based on lirascore

Conditions: Non-small Cell Lung Cancer

Summary: this is a multi-center, observational clinical study to explore the role of lirascore in predicting immunotherapy monotherapy and combination with chemotherapy efficacy and prognosis in locally advanced or metastatic non-small-cell lung cancer. the study plans to enroll 108 patients. the primary endpoint of this study was orr, and secondary endpoints were pfs, os, dor, dcr, and safety.


Eligibility criteria:
inclusion criteria: 1. patients voluntarily participated in the study, signed the informed consent, and had good compliance; 2. histologically and/or cytologically confirmed previously untreated, locally advanced or metastatic non-small-cell lung cancer (stage iiib/iiic or stage iv) without driver gene mutation; 3. patients are willing to receive immunotherapy monotherapy or immunotherapy combined with chemotherapy; 4. the patient agrees to provide the remaining tissue samples after clinical routine diagnosis during the baseline period for lira score and pd-l1 immunohistochemical testing; 5. the eastern organization for oncology (ecog) physical fitness score is 0 or 1; 6. the patient has at least one measurable or unmeasurable but evaluable lesion. exclusion criteria: 1. according to clinical routine, patients do not meet the criteria for receiving standard anti-tumor treatment; 2. patients with known egfr mutations, alk rearrangements or ros1 rearrangements are not eligible to participate in this study; 3. according to the researcher's judgment, the patient is not suitable to participate in this study.

Keywords: immunotherapy lira score biomarker
patient-reported outcomes in real-life of cabotegravir and rilpivirine

Conditions: Quality of Life

Summary: context the introduction of the long-acting injectable antiretroviral treatment cabotegravir and rilpivirine into the therapeutic armamentarium for people living with hiv represents a potentially significant evolution in patients' experience of their treatment and pathology. its effects on the quality of life of plhiv are explored in this research. in addition, the two-monthly intra-muscular injection regimen also raises questions about the city-to-hospital transition of care for plhiv, as well as compliance with the therapeutic window. main objective to evaluate the effect of switching hiv treatment to cab+rpv la on health-related quality of life on the "treatment impact" dimension of the proqol-hiv questionnaire, 15 months after switching treatment. population people living with hiv-1 whose arv treatment has been changed to an injectable cab+rpv la treatment study design observational study. inclusion at hiv medical follow-up visit for change of arv treatment to cab/rpv. self-administered questionnaires at m3, m9 and m15 after change of treatment (first cab/rpv injection).


Eligibility criteria:
inclusion criteria: * hiv-1 carriers * patients who changed treatment (as part of routine care) to injectable cab+rpv at the same visit as the inclusion visit * hiv-rna less than or equal to 50 copies/ml for at least 6 months prior to inclusion visit * patient 18 years of age or older * patient able to read, understand and answer self-questionnaires in french exclusion criteria: * pregnant or breast-feeding women * known hypersensitivity to cabotegravir or rilpivirine * documented resistance to cabotegravir or rilpivirine * chronically active hepatitis b (hbsag+) * any pathology or history of treatment which, in the investigator's judgment, would contraindicate the patient's inclusion in the study or prevent him/her from following the constraints of the protocol.

Keywords: long-acting injectable regimen hiv patient-reported outcomes treatment switch
yoga as a treatment for insomnia

Conditions: Insomnia

Summary: the purpose of this study is to evaluate the effectiveness of a daily, 8-week treatment for insomnia using yoga, relaxation exercises or sleep hygiene.

insomnia is a sleep disorder characterized by a chronic difficulty in initiating and maintaining sleep which has a relatively high prevalence and a significant socioeconomic cost. there is good evidence that cognitive and/or physiological arousal, associated with sustained sympathetic activation, is one of the underlying causes of insomnia. relaxation treatments such as progressive relaxation and meditation which address the cognitive and somatic arousal associated with insomnia have been found to be effective. yoga is a comprehensive discipline which includes physical exercises, postures, breathing techniques, and meditation, for the purpose of improving health and well being. research studies have documented the effectiveness of yoga in reducing sympathetic activation and cognitive and somatic arousal and in the treatment of specific medical disorders. although it has been used and recommended for the treatment of insomnia, its effectiveness has not been evaluated in a randomized, controlled study. the aim of this proposal is to evaluate the effectiveness of yoga, relaxation exercises or sleep hygiene in the treatment of chronic psychophysiological insomnia. a subjective measure of sleep onset latency will be derived from daily sleep diaries, and an objective measure will be drawn from polysomnographic recordings. sleep onset latency will be evaluated before and after a two month treatment period in a total of 48 young men and women who have been carefully screened for psychiatric and medical disorders. subjects will be assigned to a yoga, relaxation exercise, or sleep hygiene treatment group. we anticipate that yoga practice will prove to be an effective treatment for insomnia which will yield significant improvements in sleep onset latency. we also anticipate that these improvements will be maintained at long-term follow up evaluation.

Eligibility criteria:
inclusion criteria * a primary complaint of sleep-onset insomnia for at least 6 months. * reside in the metropolitan boston area exclusion criteria * no current other nonpharmacological treatment for insomnia. * ability or willingness to discontinue use of hypnotic medications. * no rotating or night shift work, or transcontinental travel throughout the course of the study protocol. * no recent or anticipated major life stressors over the course of the study protocol (e.g. impending divorce or terminal illness of a relative).

Keywords: insomnia yoga meditation behavioral treatment
emst and swallowing in long-term survivors of hnca

Conditions: Head and Neck Neoplasms; Deglutition Disorders

Summary: this study is a randomized trial examining the impact of expiratory muscle strength training (emst) on oral intake, swallowing function, and swallow-related quality of life in persons treated for cancer of the head and neck (hnca) with radiation therapy or chemoradiotherapy (rt/crt) at least 5 years previously.

twenty (20) persons treated for cancer of the head and neck (hnca) with radiation therapy or chemoradiotherapy (rt/crt) at least 5 years previously will be randomized to an 8-week program of either emst only and standard care only in order to examine the impact of emst on swallowing function. the emst program will consist of 5 sets of 5 breaths, 5 days per week for 8 weeks at 75% of maximum expiratory strength. patients randomized to the emst group will use the emst150 (product name) expiratory muscle strength trainer according to package instructions. standard care will include swallowing exercises designed to strengthen muscles that contribute to pharyngeal phase motor events and increase structural range of motion. subjects will be instructed to practice these exercises following a progressive protocol 5 days per week for 8 weeks. all subjects will be evaluated at baseline and at the completion of their rehabilitation program. assessment will include measurement of maximum expiratory pressure (mep), a videofluoroscopic swallow study (vfss) to objectively document swallow function, administration of swallow-related quality of life (qol) questionnaires, and documentation of current diet using the international dysphagia diet standardisation initiative (iddsi) drink levels and food levels.

Eligibility criteria:
inclusion criteria: 1. subject was treated for cancer in the oral cavity, oropharynx, hypopharynx, larynx, or for an unknown primary at least 5 years prior to enrollment. subjects may have had surgery as long as a minimum dose of 50 gy of radiation was part of the treatment; 2. subject must have a current swallow complaint or impairment; these include but are not limited to reduced oral intake, perceived difficulty with bolus transport (e.g. feeling of food sticking in throat); aspiration on various bolus consistencies; 3. ability to follow directions and engage in a program of rehabilitation exclusion criteria: 1. the subject's swallowing problems are unrelated to treatment for hnca (e.g. cognitive impairment, history of stroke); 2. the subject presents with contraindications for emst as specified in the emst150 package insert unless cleared for participation by the subject's physician. these conditions include untreated hypertension, untreated gastroesophageal reflux diseas, recent stroke, lung disease, and pregnancy.

Keywords: oropharyngeal cancer laryngeal cancer swallow chemoradiation expiratory muscle strength training long-term survivor