Kornimate/medical-research-clean huggingface dataset:
efficacy study of water drinking on pkd progression.

Conditions: Autosomal Dominant Polycystic Kidney Disease; Disease Progression

Summary: this is a prospective 5-year study to compare the change in total kidney volume (tkv) before and after tolvaptan therapy, as the primary endpoint, in patients with adpkd.

tolvaptan was approved in japan for the treatment of autosomal dominant polycystic kidney disease (adpkd) in march 2014. this is a prospective 5-year study to compare the change in total kidney volume (tkv) before and after tolvaptan therapy, as the primary endpoint, in patients with adpkd. study results will be summarized, analyzed, and compiled into a research paper at 3 years (data cut-off, march 31, 2018) and at 5 years (data cut-off, march 31, 2020)

Eligibility criteria:
inclusion criteria: * the patients with adpkd * the patients who consent to the study protocol * estimated glomerular filtration rate (egfr) or creatinine clearance greater than 50ml/min/1.73m2 exclusion criteria: * patients who might be danger to drink large amount of water such as having heart failure or past history of cerebrovascular or cardiovascular disorders. * the patients who take habitual medication which affects the avp action such as selective serotonin reuptake inhibitors (ssri ), tricyclic antidepressants or diuretics. * the patients who is considered inappropriate by physicians.

Keywords: autosomal dominant polycystic kidney disease. arginine vasopressin total kidney volume glomerular filtration rate
deep vein thrombosis (dvt) prevention in total hip arthroplasty: continuous enhanced circulation therapy (cect) versus low molecular weight heparin (lmwh)

Conditions: Deep Vein Thrombosis of Lower Limb; Pulmonary Embolism (PE); Bleeding

Summary: evaluation of the safety and effectiveness of activecare+ cect device +/- baby dose aspirin (81 mg qd) for lowering the potential risk for bleeding and of dvt during and after tha surgery in comparison with lmwh.

patients undergoing total hip arthroplasty surgery are at particular risk for thromboembolic disease. to date two prophylactic modalities are being used: mechanical (intermittent pneumatic compression \[ipc\]) and pharmacological (anticoagulant). both are effective; however each carries its own advantages and disadvantages. the purpose of this study is to compare in total hip arthroplasty (tha) patients the safety and effectiveness of the mobile activecare cect based prophylaxis protocol and compare it with lmwh standard of care protocol for this patient population. the protocol is based upon the cect system as the primary dvt prophylaxis method (with or without the addition of low dose baby aspirin \[81 mg\]).

Eligibility criteria:
inclusion criteria: adult patient (age \>18). patient intended to undergo elective primary unilateral tha surgery. patient is able and willing to follow instructions of care after surgery. patient is able and willing to sign the institution human subjects committee approved informed consent form. exclusion criteria: patient who has a known coagulation disorder. patient currently treated with anticoagulant medications. patient with known thrombophilia patient with current signs and symptoms of or history of dvt/pe. patient who is uncooperative or unable to follow instructions. patient currently suffering from a solid tumor malignancy. patient with active peptic disease. patient with known allergy to baby aspirin (81 mg) or enoxaparin. patient with contraindication to use of the device including patients with leg gangrene, recent skin graft or medical situations where increase venous and lymphatic return is undesirable.patient has major surgery procedure within 3 months prior to the study surgery, or patients with a major surgery procedure planning during the study period.pregnant women.patient who is participating in another clinical drug trial.

Keywords: safe cect sft activecare activecare+sft deep vein thrombosis prevention total hip replacement total hip arthroplasty low molecular weight heparin mcs
effectiveness and safety of celstat for hemostasis in intraoperative tissue bleeding

Conditions: Bleeding Active

Summary: the study is to evaluate the effectiveness and safety of celstat vs active control.


Eligibility criteria:
inclusion criteria: preoperative 1. subject is undergoing planned cardiothoracic, general or vascular surgery intraoperative 1. mild or moderate soft tissue, vascular or parenchymal bleeding present at target bleeding site after standard conventional surgical hemostatic methods prove to be ineffective or impractical. exclusion criteria: preoperative 1. subject needs emergency surgery 2. subject will undergo renal transplantation, or minimally invasive/laparoscopic surgery 3. subject will undergo neurological or ophthalmological surgery 4. subject will undergo urological or gynecological surgery 5. subject has congenital coagulation disorder 6. subject is pregnant or lactating at the time of enrollment, or becomes pregnant prior to the planned surgery intraoperative: 1. occurrence of any surgical complication that requires resuscitation or deviation from the planned surgical procedure prior to identification of target bleeding site 2. disseminated intravascular coagulopathy

Keywords: hemostasis oxidized cellulose strip traumacel traumastem cardiothoracic surgery general surgery vascular surgery
post-market clinical evaluation of the zephyr valve 5.5-lp ebv

Conditions: Pulmonary Emphysema

Summary: this is a post-market evaluation of the zephyr valve 5.5-lp ebv to assess treated lobar volume reduction (tlvr), changes in lung function and the safety profile of the zephyr valve treatment with the use of at least one zephyr valve 5.5-lp ebv.

this is a multi-center, single-arm, prospective, observational study. approximately 70 study participants undergoing zephyr valve treatment with the use of at least one zephyr valve 5.5-lp ebv will be enrolled and followed out to 3 months. assessments will be conducted at 45 days and 3 months. the evaluation will be conducted at up to 6 sites. patients prescribed zephyr valve treatment for their emphysema will be consented and will be enrolled only after: 1) determination of little to no collateral ventilation between target and ipsilateral lobes and 2) implantation of at least one zephyr valve 5.5-lp ebv. baseline data will be collected retrospectively after enrollment of a patient in the post-market evaluation. performance and safety of the zephyr valve treatment with the use of at least one zephyr valve 5.5-lp will be evaluated post-treatment based on data collected until 3 months after the treatment.

Eligibility criteria:
inclusion criteria: * patients with severe emphysema prescribed treatment with zephyr valves * zephyr valve treatment with the use of at least one zephyr valve 5.5-lp ebv exclusion criteria: * patients determined to have collateral ventilation between the target(s) and ipsilateral lobe(s). * patients who undergo zephyr valve treatment, but no zephyr valve 5.5-lp ebv implanted.
oral anticoagulant discontinuation, adherence patterns, hospitalizations and costs in non-valvular atrial fibrillation (nvaf) patients

Conditions: Atrial Fibrillation

Summary: to describe the rate of discontinuation among non-valvular atrial fibrillation (nvaf) patients who were on warfarin and have switched to the novel oral anticoagulants(noacs).


Eligibility criteria:
inclusion criteria: * individuals with nvaf who were on warfarin and have switched to the noacs (dabigatran, rivaroxaban and apixaban) within the study period january 01, 2013 through march 31, 2014 * individuals ≥18 years old on the index date * at least 1 year of baseline period with history of continuous warfarin use in the baseline period for at least 3 months immediately before the index date * at least 1 diagnosis of af in the 12 months prior to index date * continuous eligibility with medical and pharmacy benefits for at least 12 months before the index date through 1 month after the index date exclusion criteria: * individuals with a diagnosis of valvular heart disease or cardiac surgery during the 12 months prior to index date
the therapeutic effect of catgut embedding in obesity

Conditions: Obese Women

Summary: the aim of this double-blind, randomized, placebo-controlled trial is to evaluate the therapeutic effects of acupoint stimulation by catgut embedding on complexion, quality of life, lipid profile, inflammatory markers, and obesity-related hormone peptide of obese women.

we will recruit 90 females aged from 16 year-old to 65 year-old with body mass index(bmi) 27㎞/㎡ and waist circumference≧80cm. after inform consent, they will be randomly assigned into two groups. in group a, catgut embedding will be applied to six acupuncture points on the abdomen including qihai (ren-6), shuifen (ren-9), bilateral shuidao (st-28) and siman (st-26), which have been proved to be effective on obesity in our previous study, once each week for six times. in group b, sham catgut embedding will be applied on the same acupoints once each week for six weeks. this trial will go on for six weeks with six course of treatment. our primary outcome measurements is complexion which included body mass index(bmi),waist circumstances, and waist-hip ratio. in our second outcome measurments, we will evaluate the life quality of these patients using 12-item short form health survey (sf-12) which developed for the medical outcomes study (mos) and also using questionnaire of quality of life that was designated by world health organization. we will also classify the patients by questionnaire designed for tcm syndrome of obesity. we will check blood test included lipid profile (tg, chol, hdl-c, ldl-c), inflammatory markers, and hormone peptide related to obesity such as insulin,leptin,ghrelin,adiponectin. each enrolling patients will be evaluated at the baseline before treatment and after 6 times treatments completed by above parameters to find out the therapeutic effects and mechanism of catgut embedding in acupoints in obese women.

Eligibility criteria:
inclusion criteria: * body mass index (bmi) ≥ 27 kg/m2 waist circumference (wc) ≥ 80 cm and willing to participate in and fill out the questionnaires for this trial. exclusion criteria: * endocrine disease(thyroid disease, pituitary disease, diabetes mellitus) autoimmune disease（sle、sss、ra） heart disease(heart failure, arrhythmia etc.） abnormal liver function（got\>80u/l、gpt\>80u/l） abnormal kidney function（serum creatinine\>2.5 mg/dl） stroke disease in past one year under breast feeding or pregnancy coagulation disorder subjects with keloid disorder accept weight reduction treatment in last two months

Keywords: catgut embedding obese women obesity-related hormones
the possible efficacy and safety of lansoprazole co-administration with neoadjuvant chemotherapy in women with breast cancer

Conditions: Breast Cancer

Summary: investigation of the possible efficacy and safety of lansoprazole co-administration with neoadjuvant chemotherapy in tumor response in women with breast cancer who will be planned for surgery.

several studies revealed that ppis inhibit not only the h+/k+ atpase in gastric parietal cells, but also the vacuolar h+ atpase (v-atpase) overexpressed in tumor cells, the v-atpase is an atp-dependent proton pump that transports h+ across both intracellular and plasma membranes to regulate intracellular and extracellular ph. co-administration or pretreatment with ppis could inhibit h+ transport via the v-atpase in tumor cells, resulting in lower extracellular acidification and intracellular acidic vesicles which increase the sensitivity of the tumor cells to the anticancer agents. moreover, the low extracellular ph induces an increased activity of drug efflux pumps p-glycoprotein (p-gp), which is closely associated with multi-drug resistance (mdr) of tumors. as a consequence, there remains a lower concentration of chemotherapeutic drugs in tumor cells and reduced cytotoxic efficacy, thus restoring the normal extracellular ph will decrease mdr.

Eligibility criteria:
inclusion criteria: * females with age ≥ 18 years old. * newly diagnosed breast cancer patients. * planned neoadjuvant chemotherapy. exclusion criteria: * pregnancy. * nursing mothers. * active or uncontrolled infection. * presence of another malignancies. * inadequate blood picture. * serum creatinine more than 1.5 mg /dl. * ast and alt more than 2.5 upper limit. * history of known hypersensitivity to lansoprazole.
prevalence and prognosis of cardiac amiloidosis in turkey

Conditions: Cardiac Amyloidosis

Summary: patients with left ventricular hypertrophy are further examined according to an algorithm to check if they have a cardiac amyloidosis


Eligibility criteria:
inclusion criteria: * patients with left ventricular hypertrophy without left ventricular pressure or volume (ivs≥13mm) * patients with left ventricular hypertrophy and hypertension or aortic stenosis without left ventricular pressure or volume (ivs\>15mm) exclusion criteria: * patients with left ventricular pressure or volume except the ones with aortic stenosis and arterial hypertension * patients with sigmoid septum and their hypertrophy limited in sigmoid area * patients with highly probable sarcometric hypertrophy cardiomyopathy confirmed with lv morhpology and genetic testing
therapeutic response of ultrasound and muscular stretching in temporomandibular disorder patients

Conditions: Temporomandibular Joint Disorders

Summary: the combination of ultrasound and muscular stretching may have positive effects on pain relief and on the balance of the masticatory muscles activity.

this study aimed to evaluate the therapeutic response of ultrasound (us) and ultrasound associated with stretching of the masticatory muscles on the pressure pain threshold and the electrical activity of masseter and anterior temporal muscles in temporomandibular disorder (tmd) patients . the study included 18 women with tmd diagnosed by the instrument research diagnostic criteria for temporomandibular disorders (rdc / tmd). the pressure pain threshold, evaluated through algometry, and the electrical activity of the masticatory muscles were evaluated, by means of surface electromyography, before and immediately after the therapeutic procedures. the volunteers underwent three different interventions: ultrasound, ultrasound associated with stretching and ultrasound placebo, with a 1-week of minimum interval between them.

Eligibility criteria:
inclusion criteria: * diagnosis of myogenic or mixed tmd according to the research diagnostic criteria for temporomandibular disorders (rdc / tmd) * women aged 20 to 35 years. exclusion criteria: * psychomotor impairment ; * history of orthopedic trauma involving the temporomandibular region , orofacial surgery or poor training ; * analgesics , anti-inflammatories , muscle relaxants , antidepressants ; * presence of acute tmj pain ( last 3 months) ; * have perform physical therapy or speech therapy for the past 6 months; * periods of the end of the menstrual cycle (7 days prior to menstruation ) and onset of menstruation ( first 2 days ) were excluded for conducting evaluations of volunteers who did not use oral contraception and those who used it to break.

Keywords: temporomandibular joint disorders, ultrasonics, electromyography, pain measurement, muscle stretching exercise
non-invasive spinal cord stimulation after spinal cord injury

Conditions: Spinal Cord Injuries; Spinal Cord Diseases

Summary: spinal cord injury (sci) is a central nervous system injury that often leads to motor dysfunction. non-invasive electrical stimulation of the spinal cord has been recognized as a potential method of reactivating lost spinal neural networks to improve motor recovery and exercise response after sci. trans-spinal electrical stimulation (ts-es) has been found to increase functional gains in people after sci when applied in combination with other motor training protocols. this project aims to evaluate the effects of non-invasive lumbar spinal cord electrical stimulation on the motor function of trunk and lower limbs in people with sci after augmenting their locomotor training (treadmill stepping) with step-cycle-based electrical peripheral neural stimulation methods.

this project will evaluate the effects of non-invasive lumbar ts-es on locomotor function in people with incomplete motor sci (isci) who retain some ability to stand or walk. this study has 3 phases: baseline assessment - 2 sessions - week 1 -lab visits #1-2 locomotor training with varied electrical stimulation- 12 sessions - weeks 2-5 - lab visits #3-14 (1hr, x3/week) end of training assessment - 2 sessions - week 6- lab visits #15-16. specific locomotor deficits of each participant will be evaluated, and their step-cycle-based peripheral muscle or nerve stimulation strategy will be determined accordingly to improve stance or step capacity. after augmenting their locomotor function with muscle or peripheral nerve stimulation-induced activation strategies that address particular and unique motor deficits, they will receive intermittent bouts of stance or locomotor training supplemented with ts-es. the locomotor training will consist of standing/walking on a treadmill with appropriate bodyweight support and added muscle or peripheral nerve stimulation. specifically, the project aims to assess the following: 1. does combined muscle (nmes) or peripheral nerve (pn) stimulation with ts-es during treadmill stepping facilitate locomotor performance? 2. does four weeks of combined training as described above (1hrx3/week) facilitate exercise capacity (measured by submaximal vo2) in persons with chronic isci?

Eligibility criteria:
inclusion criteria: * has spinal cord injury, 6 mo or longer since injury * is between 20 and 65 years of age * has difficulty with trunk and/or lower limb function * stable medical condition * non-progressive etiology of spinal injury * no ventilatory support exclusion criteria: * genetic or degenerative etiology of spinal injury * need for ventilatory or other life-sustaining medical support * history of cardiovascular or pulmonary complications (heart failure, severe hypertension etc.)

Keywords: trans-spinal electrical stimulation locomotor training functional electrical stimulation peripheral nerve stimulation
laparoscopic versus vaginal cuff closure during lh in benign gynecological lesions

Conditions: Uterine Diseases

Summary: to compare vaginal cuff closure via bakay purse string with vaginal cuff closure via vaginal route with continuous locked suturing after total laparoscopic hysterectomy for benign lesions.

the objective of the present study is to compare 2 different methods for vaginal cuff closure after total laparoscopic hysterectomy for benign lesions regarding operative time, vaginal length, vaginal cuff dehiscene, hematoma formation. the first method is the bakay purse string and the second is the closure of the vault via vaginal route with continuous locked suturing.

Eligibility criteria:
inclusion criteria: * benign uterine lesions e.g fibroid, adenomyosis,...etc. * patient acceptance to undergo laparoscopic hysterectomy. exclusion criteria: * gynecological malignancy. * low corporeal myoma obsecuring cervicovaginal junction. * history of extensive abdominal surgery other than cesarean section.

Keywords: tlh bakay purse string
quantifying digital behavior on smart phones - data from stroke survivors

Conditions: Stroke

Summary: in this study, we want to continuously record the interaction of 50 stroke survivors with their smartphones during the first 3 months after discharge. the linkage of smart phone use to function and quality of life will be assessed with standardized outcome measures at defined time points.

people with stroke are among the most relevant target groups for unobtrusive monitoring. worldwide, stroke is the second most frequent cause for lasting disability and causes a substantial burden for the individual, caregivers and society. thanks to improved treatment, many stroke survivors can be discharged to their homes. however, many have to live with disabilities and are prone to declining function, cognitive impairment and depression. with the acquired data, we want to create a database where digital behavior is analyzed with advanced computational methods. in collaboration with the department of cognitive psychology, university of leiden, netherlands, these data will be used to discover specific features for different health issues and to develop tools for the early detection of functional decline for different populations.

Eligibility criteria:
inclusion criteria: * new or recurrent stroke, admitted to rehabilitation, discharge to own home * owns an android smart phone * smart phone is used by the patient only exclusion criteria: * severe cognitive impairments and / or psychiatric and behavioral conditions that interfere with compliance. * not able to provide informed consent * discharge to nursing homes or other care facilities

Keywords: stroke, digital behavior, health-related quality of life, cognitive function
feasibility of a hybrid delivery of home-based cluster set resistance training in lung cancer

Conditions: Non Small Cell Lung Cancer; Resistance Exercise

Summary: symptom burden remains a critical concern for individuals with non-small cell lung cancer (nsclc) following the completion of treatment. of those, symptom clusters such as dyspnea (shortness of breath) and fatigue, contribute to physical decline, reductions in quality of life, and a higher risk of comorbidities and mortality. it has been proposed that dyspnea is a primary limiter of exercise capacity in individuals with lung cancer, resulting in exercise avoidance and an accelerated physical decline. as such, specifically designing resistance exercise programs with cluster sets, to mitigate feelings of dyspnea and fatigue may result in improved exercise tolerance, resulting in the maintenance of physical function and quality of life. the purpose of this project is to investigate the feasibility and preliminary efficacy of a hybrid-delivery of home-based cluster-set resistance exercise in individuals with nsclc. methods: individuals with nsclc (n=15), within 12-months of completion of treatment will be recruited to participate in this single arm feasibility trial. participants will complete 8-weeks of home-based resistance training (rt) designed to target dyspnea and fatigue. the hybrid-delivery of the program will include supervised sessions in the participants home, and virtual supervision via video conferencing. the primary outcome of feasibility will be measured via recruitment rates, retention, acceptability and intervention fidelity. exploratory outcomes (dyspnea, fatigue, quality of life, physical function and body composition) will be assessed pre- and post- intervention.

analysis plan. descriptive statistics (percentages and means (with standard deviations)) will be used to report on feasibility outcomes (recruitment, retention, fidelity etc.). unless explicitly stated, means and standard deviations will be reported for assessments of exploratory outcomes at baseline and follow-up.

Eligibility criteria:
inclusion criteria: * completed definitive treatment for localized nsclc (stages i-iii) * has access to stable internet access for zoom participation * willing to complete an 8-week, home-based intervention program that includes face-to-face and zoom interaction. * willing to consider behavior change at this time. * able to speak and read english. * capable of informed consent * has obtained medical clearance from medical practitioner or medical team exclusion criteria: * individuals with a known diagnosis of advanced lung cancer (stage iv; due to potential added burden) or diagnosis of small-cell lung cancer, * anyone for whom physical activity is not recommended. * aren't comfortable having study staff visit their homes for exercise sessions * have any neuromuscular, cardiovascular, or psychological condition precluding safe exercise; * have participated in structured re ≥2 times/week for the past 6 months; * are unable to read/understand english.

Keywords: exercise physical activity lung cancer