Kornimate/medical-research-clean huggingface dataset:
validation of the hospital frailty score in france

Conditions: Elderly; Emergency Hospitalization; Frailty

Summary: older people are increasing users of health care globally. constraints in bed capacity and resources raise important challenges with regards to management of older people with complex needs, which usually require assertive and holistic assessment. it is important, therefore, to identify aged patients most likely to benefit from such frailty-attuned approaches of care. a previous study using national hospital episodes statistics conducted in the united kingdom (uk) showed that patients aged over 75 years with characteristics of frailty and at risk of adverse health-care outcomes can be identified using routinely collected data (gilbert t et al., lancet 2018). this study lead to the development of the hospital frailty risk score (hfrs), which is based on international statistical classification of diseases and related health problems 10 (icd-10) diagnosis codes and has the potential to be used in other countries worldwide, using the icd-10 coding framework, to identify patients at risk of frailty at the hospital and commissioners levels, as well as for database research purposes. this score has successfully been validated in canada, australia and switzerland. the aim of the present study is to evaluate the ability of the hfrs to predict 30-day in-patient mortality of patients aged 75 years and older admitted to french hospitals as an emergency.


Eligibility criteria:
inclusion criteria: * age 75 years or over (on the day of the index admission) * hospitalized as an emergency (i.e. after visit to ed) exclusion criteria: * none
a phase 1 study of ertugliflozin in healthy male participants (mk-8835-020)

Conditions: Type 2 Diabetes Mellitus

Summary: this study will evaluate the absolute oral bioavailability (f) and fraction absorbed (fa) of ertugliflozin following oral administration of unlabeled ertugliflozin (mk-8835) and intravenous (iv) and oral administration of 14\^c-labeled ertugliflozin in healthy male participants.


Eligibility criteria:
inclusion criteria: * healthy male subjects between the ages of 18 and 65 years. * body mass index (bmi) of 17.5 to 30.5 kg/m\^2; and a total body weight \>50 kg (110 lbs.) exclusion criteria: * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies). * any clinically significant malabsorption condition (eg, gastrectomy, bowel resection). * a positive urine drug screen for drugs of abuse or recreational drugs. * positive hepatitis b surface antigen (hbsag), hepatitis c virus antibody (hcv ab) or human immunodeficiency virus (hiv) results. * history of abuse of alcohol or binge drinking and/or any other illicit drug use or dependence within 6 months of screening. * current smokers and those who have smoked any substance within the last 12 months. * treatment with an investigational drug within 1 month preceding the first dose of study medication. * have participated in any clinical study with exposure to 14\^c in the last 12 months. * any radiation exposure, including that which is projected to result from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures. no occupationally exposed worker, as defined in the ionising radiation regulation 1999, shall participate in the study. * use of prescription or nonprescription drugs (including vitamins and dietary supplements) within 7 days prior to the first dose of study medication. * use of herbal supplements within 28 days prior to the first dose of study medication. * blood donation (excluding plasma donations) of approximately 1 pint (500 ml) or more within 56 days prior to dosing. * participants who have previously participated in a clinical trial for ertugliflozin. * serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients.
internet-delivered act for treating the psychological effects of hearing loss

Conditions: Hearing Loss

Summary: randomized trial comparing internet-delivered act with therapist support against waiting list for persons with hearing loss and comorbid psychological distress

hearing loss is the most common sensory disability in the world. hearing loss is an auditory disability which affects not only speech recognition, but also the ability to recognize, locate and identify sounds in one's environment. today there are a variety of studies investigating the relationship between hearing loss and mental health. for example, there are studies showing that hearing loss can lead to depression, somatization, social isolation, worrying or anxiety, loneliness, smaller social networks, lower self-efficacy, sensitivity to stress, burnout, and impaired sleep quality and quality of life in comparison with people with normal hearing. initial results from other studies indicate that acceptance may be of importance, as it in turn can lead to increased help-seeking.to avoid prolonged stress and a healthy self-efficacy could contribute to greater well-being of people with hearing loss. this is the first study to use act to improve psychological health in people with hearing loss through the process of psychological flexibility. the treatment is eight weeks long and internet delivered through self-help texts with weekly therapist support.

Eligibility criteria:
inclusion criteria: * hhie-s score over 8 * indication of comorbid psychological suffering/distress (defined as total score above 0 on phq9/gad7 or below 1sd on qoli) exclusion criteria: * no computer with internet connection * unability to understand written content * incomplete screening procedure * a health condition that needs immediate care

Keywords: psychological effects
embolization for the treatment of pain secondary to adhesive capsulitis

Conditions: Frozen Shoulder; Adhesive Capsulitis

Summary: this study is to test a new treatment method, arterial embolization of the shoulder (aes), to reduce the severity of pain and improve range of motion (rom), and to see if it can be performed safely.

purpose: the primary aims of this study are to determine if arterial embolization of the shoulder will reduce the severity of pain as well improve range of motion (rom) caused by adhesive capsulitis and if it can be performed safely. the secondary aim is to determine if aes can result in the decreased necessity for ongoing conservative therapies, such as medication therapy and joint injections. participants: twenty patients with adhesive capsulitis, resulting in shoulder pain that is refractory to conservative therapies, who are not planning to undergo surgery within 6 months. procedures (methods): this will be an open label 24-month pilot study with a small population undergoing aes to determine safety and efficacy. clinical procedures and evaluations will consist of a preoperative screening assessment to determine if the potential study subject meets the inclusion and exclusion criteria, enrollment, surgical procedure for arterial embolization of the shoulder, and follow-up visits at 24 hours, 1, 3 \& 6 months. an mri will be performed at the 1-month visit to detect a change in capsular vascularity and to exclude complication.

Eligibility criteria:
inclusion criteria: * moderate to severe shoulder pain (vas greater than 40mm), and * diagnosis of adhesive capsulitis, and * age \> 21, and * pain refractory to at least 30 days of conservative therapy (pain medications, physical therapy, etc.) exclusion criteria: * current local infection, or * life expectancy less than 6 months, or * known advanced atherosclerosis, or * rheumatoid or infectious arthritis, or * prior shoulder replacement surgery, or * uncorrectable coagulopathy as defined by inr \> 2.5 or platelets \< 30,000, or * iodine allergy resulting in anaphylaxis, or * renal dysfunction as defined by grf of \< 45, or * contraindication for magnetic resonance imaging, or * known complete full thickness tear of rotator cuff, or * currently pregnant
continued treatment with docetaxel versus switch to cabazitaxel after minor prostate specific antigen response to docetaxel in patients with castration-resistant metastatic prostate cancer

Conditions: Prostatic Neoplasms

Summary: primary objective: * to compare the continuation of treatment with docetaxel versus switching to cabazitaxel regarding the time to psa (prostatic specific antigen) progression (ttp-psa), in patients with castration-resistant prostate cancer (crpc) that, after four cycles of docetaxel, have minor psa response (defined as a reduction between 1% and 49%) or increase of up to 24% in psa levels. secondary objectives: * psa response rate * overall survival (os) * incidence of adverse events

screening: 21days (+7 days) treatment: until psa progression post-treatment follow-up: 2 years

Eligibility criteria:
inclusion criteria : * documentation of histological prostate cancer; * patients with metastatic crpc (castration-resistant metastatic prostate cancer) who progressed with hormone deprivation, including the withdrawal of antiandrogen-class drugs for at least 4 weeks, and 6 weeks for bicalutamide or if documented that psa did not decrease during 3 months of this therapy; * documentation of metastasis by imaging (computerized tomography \[ct\], magnetic resonance imaging \[mri\] or bone scan), in patients with psa \< 20 ng/ml at the time of inclusion * provide minor psa response (characterized by a reduction between 1% and 49%) or increase up to 24% in psa levels, in relation to the value measured before starting docetaxel therapy, measured at least 7 days after the fourth cycle of docetaxel; * patient has received 4 cycles of docetaxel at a dose of 75 mg/m2 ; * ecog performance status of 0 or 1; * marrow, liver and renal function within acceptable values; * psa ≥ 2 ng/ml; * testosterone level ≤ 50 ng/dl (for patients with no prior history of orchiectomy). exclusion criteria: * prior use of chemotherapy, except for docetaxel for four cycles; * documented disease progression during treatment with docetaxel (first 4 cycles); * patients with metastases resulting in neurological damage; * inability to continue receiving gonadotropin-releasing hormone agonists in patients with no prior history of orchiectomy; * use of recombinant methionyl human granulocyte-colony stimulating factor non-glycosylated (g-csf) in the 24 hours preceding baseline; * any other current neoplasia or over the past 5 years, except for basal cell skin carcinoma or squamous skin cell carcinoma; * known seropositivity for hiv (human immunodeficiency virus ); * concomitant diseases, such as significant neurological or psychiatric disease; uncontrolled hypercalcemia or any other serious comorbidity; * hypersensitivity or allergy to any of the study treatments. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
noninvasive electrical stimulator as a pain control treatment post-ureteroscopy

Conditions: Kidney Stone; Ureteral Calculi; Nephrolithiasis

Summary: the investigators will assess the use of transcutaneous neurostimulation (tens), a pharmacological alternative, for treatment of ureteral stent pain post-ureteroscopy. the primary aim for the investigators is to determine if use of a tens unit will reduce post-operative pain and nausea associated with the ureteral stent. secondary aim will be to assess if it can help minimize narcotic use.


Eligibility criteria:
inclusion criteria: * adult patients undergoing standard of care ureteroscopy and laser lithotripsy for urinary stone disease * patients receiving a stent following their ureteroscopy and laser lithotripsy exclusion criteria: * children * pregnant patients * patients unable to answer pain questionnaire * patients undergoing pcnl * patients being treated for urologic malignancy with ureteroscopy * patients who require long term or chronic ureteral stent management * patient with implantable stimulators * patient with epilepsy * patients undergoing laser lithotripsy without stent placement
an open-label, single dose study in patients with alcohol use disorder

Conditions: Alcohol Use Disorder

Summary: an open-label, phase 2a study to evaluate the safety, tolerability, and pharmacodynamic effects of a single intranasal dose of bpl-003 combined with relapse prevention psychological support, to explore the potential effects on alcohol use and related symptoms in patients with alcohol use disorder.

approximately 12 eligible participants will be receive a single dose of bpl-003, given intranasally, with 12 weeks of follow-up assessments. psychological support will be given before, during and after dosing

Eligibility criteria:
inclusion criteria: 1. willing and able to give informed consent. 2. age 18 to 64 years at screening. 3. diagnosed with moderate to severe aud. 4. minimum of 4 heavy drinking days in the 28 days before screening. 5. no more than 14 days have elapsed since the last hdd or completion of detoxification, with no hdd in the 72 hours prior to dosing and no alcohol at all in the 24 hours prior to dosing 6. willing to abstain from using recreational drugs from screening until end of the study 7. willing to abstain from smoking during their time in the clinic on the day of dosing. 8. willing to refrain from psychedelic drug use from screening until the end of the study. 9. living in stable/secure accommodation in the community. 10. in possession of a personal mobile phone and able to nominate at least one locator individual (eg, a family member, friend, or recovery mentor), with a verifiable address and a telephone number to assist with the arrangement of follow-up appointments. exclusion criteria: 1. personal or first-degree family history of schizophrenia, bipolar disorder, psychotic disorder, delusional disorder, paranoid disorder or schizoaffective disorder. 2. any major psychiatric disorders, with the exception of mild or moderate anxiety and/or depression. 3. a clinical diagnosis of post-traumatic stress disorder. 4. suicide ideation or behaviour or self-injurious behaviours within the 12 months before screening 5. regular use of or dependence on other drugs other than caffeine or nicotine. 6. any self-reported use of psychedelic compounds in the past 6 months. 7. history of seizures. 8. patients who are exhibiting any signs of alcohol withdrawal on dosing day. 9. positive for alcohol on dosing day. 10. positive urine drug screen for illicit drugs or drugs of abuse. 11. any nasal obstruction, blockage, or symptoms of congestion. 12. any personal or family history of malignant hyperthermia. 13. patients with an uncontrolled cardiovascular disorder that, in the opinion of the investigator, may interfere with the interpretation of study results or constitute a health risk for the patient if he/she takes part in the study. 14. uncontrolled or insulin-dependent diabetes.
evaluating the clinical value of traditional chinese medicine in the adjuvant therapy of triple-negative breast cancer

Conditions: Triple Negative Breast Cancer

Summary: this is a prospective, single site, randomized, double-blind phase iii clinical trial to evaluate the clinical value of traditional chinese medicine in the adjuvant therapy of triple-negative breast cancer patients.


Eligibility criteria:
inclusion criteria: * women aged 18-70 years old; * pathologically confirmed stage i-iii breast cancer after early breast cancer surgery, and is confirmed by histopathology to be triple negative breast cancer (estrogen receptor (er)-negative/ progesterone receptor (pr)-negative/ human epidermal growth factor receptor 2 (her2)-negative). her2-negative is defined as a negative in situ hybridization test or an immunohistochemistry (ihc) status of 0, 1+ or 2+. if ihc is 2+, a negative in situ hybridization test is required by local laboratory testing; * has an eastern cooperative oncology group (ecog) performance status of 0 or 1; life expectancy is ≥ 6 months; * has adequate organ function meeting the following criteria: (1) adequate bone marrow function: hemoglobin ≥ 90 g/l (no blood transfusion within 14 days); absolute neutrophil count ≥ 1.5 x 109 /l; platelet count ≥ 100 \* 109 /l; (2)adequate liver and kidney function: alanine aminotransferase (alt) ≤ 3×upper limit of normal (uln), aspartate aminotransferase (ast) ≤ 3×uln, total bilirubin (tbil)≤ 1.5×uln, serum creatinine ≤ 1×uln，and with endogenous creatinine clearance rate of \>50 ml/min (cockcroft-gault formula). * participant has completed the last of their post surgical radiotherapy and chemotherapy within the last 6 months before date of enrollment, and no tumor recurrence or metastasis at the time of enrollment. * participants voluntarily joined the study, has signed informed consent before any trial related activities are conducted, has good compliance and has agreed to follow-up. exclusion criteria: * has bilateral breast cancer; * has previous history of additional malignancy, with the exception of adequately treated basal cell carcinoma and cervical carcinoma in situ. * has metastatic (stage 4) breast cancer; * has any \>t4 lesion (uicc1987) (with skin involvement, mass adhesion and fixation, and inflammatory breast cancer); * is pregnant, is breast feeding women, or women of childbearing age who cannot practice effective contraceptives; * patients participating in other drug related clinical trials at the same time; * has severe organ dysfunction (cardiopulmonary liver and kidney) insufficiency, left ventricular ejection fraction (lvef) \ 150/90mmgh, myocardial infarction, or cerebral blood vessel); diabetic patients with poor blood glucose control; patients with severe hypertension; * has known allergy to study medication; * has severe or uncontrolled infection; * has a history of psychotropic substance abuse and were unable to abandon drug habits, or those with history of mental disorders; * the researchers judged patients to be unsuitable for the study.

Keywords: adjuvant therapy traditional chinese medicine
the acute effects of commercially available drinks on the endothelial function of humans following a high-fat meal

Conditions: Endothelial Dysfunction

Summary: high fat diets are associated with impaired endothelial function and increased cardiovascular disease risk amongst our population. these negative effects are likely caused by triglyceride induced suppression of nitric oxide, which is produced from the endothelium, and/or an increase in oxidative stress. interestingly, previous studies have found that some beverages that are high in polyphenols and antioxidants may suppress the impairment in endothelial function observed following high fat meals/diets. typically, these studies have investigated the ingestion of red wine, orange juice or green tea on outcome measures (typically flow mediated dilatation (fmd) of the brachial artery). despite this previous research, no study has compared the effects of different beverages on endothelial outcomes following a high-fat meal within the same participants.


Eligibility criteria:
inclusion criteria: * females to be postmenopausal and not on hormone replacement therapy * 25 \> bmi \< 35 * sedentary to light activity lifestyle. exclusion criteria: * history of cardiovascular disease (hypertension, atherosclerosis, endothelial issues etc). * history of diabetes (type 1 or type 2) * vegan or with food allergies or intolerances. * taking any antioxidants over the counter (vit c, e or polyphenol supplements) * taking prescription medication for hypertension.

Keywords: antioxidants polyphenols flow-mediated dilatation
assessing outcomes with microprocessor knee utilization in a k2 population

Conditions: Lower Limb Amputation Above Knee (Injury); Congenital Amputation of Lower Limb; Lower Limb Amputation Knee

Summary: two-phased randomized controlled trial comparing the impact of microprocessor controlled knee prostheses (mpk) with the impact of non-microprocessor controlled knee prostheses (npmk) in patients with a transfemoral/knee disarticulation level amputation categorized as k2 ambulators.

randomized controlled trial investigating the benefits of microprocessor controlled knee prostheses (mpk) in patients with a transfemoral or knee disarticulation level amputation categorized by medicare functional classification level (mfcl) as a limited community ambulator (k-level 2). there are two aims for the study. aim 1 is to understand the effect of mpk technology for the k2 ambulator on reducing fear and anxiety of falling, improving health-related quality of life, and participation in society and activities. aim 2 is to understand the long-term effect of mpk technology the aspects from aim 1 as well as reducing morbidity. the trial will be conducted in two phases. phase 1 will cover the initial 12-month period to address aim 1, and phase 2 will monitor from 12 months to 5 years to address aim 2.

Eligibility criteria:
inclusion criteria: * unilateral transfemoral or knee disarticulation amputation * received prosthesis between 4 - 24 months prior * currently uses prosthesis * k2 ambulator status * able to speak english or spanish language * age ≥ 65 years at baseline assessment (one month after enrollment) * minimum socket comfort score (scs) of 6/10 exclusion criteria: * upper limb involvement * individuals ≥ 275 lbs * unable to provide informed consent * history of acute or chronic residual limb breakdown * history of 2 or more socket adjustments or replacements in the past 6 months * amputation of the contralateral limb * active malignancy * rapidly declining health status resulting in reduced activity in the past 6 months, as determined by patient's clinician and confirmed by clinical \& scientific affairs personnel * patient unable or unwilling to follow study procedures * pregnant women, institutionalized persons, and children

Keywords: prosthetic knee, lower limb amputation, microprocessor controlled knee, k2
timecard(taiwan network of post-arrest management for cardiac arrest)iiregistry

Conditions: Cardiology, Critical Care Medicine, Emergency Medical Service

Summary: this study aims to collect the post-cardiac arrest patients with icu admission.

the purpose of this study is to establish protocolized and standard post-arrest care as well as constitute a multicenter registry of post-arrest survivors, and thus to develop the taiwan predictive model of cardiac arrest survivors. the registry system may help evaluate the severity of disease illness and improve the post-arrest care.

Eligibility criteria:
inclusion criteria: * non-traumatic cardiac arrest patients * admitted to the icu exclusion criteria: * below 18 year old * pregnant * terminal illness or not receiving medical treatment * when emergency icu crowded can not provide critical care

Keywords: prognosis, post-cardiac arrest syndrome, sudden cardiac arrest, registry database, predictive model
deep friction massage for intercostal pain in patients with heart disease

Conditions: Heart Diseases; Pain

Summary: studies show that chest pain is a common complaint presented in both general practice and in emergency units. musculoskeletal causes are common, but frequently overlooked. no studies about treatment of chest pain from the intercostal muscles were found by search in medical literature databases. the purpose of this study is to evaluate the effect of two different physical therapy interventions on intercostal pain in patients with stable heart disease. the hypothesis was that deep friction massage combined with heat-pack is more effective than heat-pack only.


Eligibility criteria:
inclusion criteria: * increasing chest pain during a cardiac rehabilitation class * stable coronary disease * new re-vascularisation is not planned exclusion criteria: * unstable coronary disease * not able to perform the study * abuse of drugs or alcohol * participating in other ongoing study

Keywords: thorax intercostal muscles massage heat-pack hot temperature