Kornimate/medical-research-clean huggingface dataset:
molecular hydrogen for cognitive function and performance in elderly

Conditions: Cognitive Impairments; Aging

Summary: a variety of non-pharmacological interventions have been used in the management of alzheimer's disease (ad) and similar cognitive disorders in elderly, yet no therapeutic modality has demonstrated conclusive positive results in terms of effectiveness. although it is still unknown what triggers ad, recent studies have shown that ad is associated with brain energy depletion, oxidative stress, and mitochondrial dysfunction. since supplemental molecular hydrogen (h2) supports cell energy production and acts as a highly bioavailable mitochondria-related antioxidant, it may provide an ideal agent to facilitate treatment and perhaps prevention of ad and similar cognitive disorders in elderly. the overall hypothesis to be evaluated in this project is that administration of h2 will positively affect patient-reported outcomes and clinical biomarkers in men and women suffering from ad.


Eligibility criteria:
inclusion criteria: * age over 65 * no psychiatric comorbidities exclusion criteria: * use of dietary supplements 4 weeks before study commence
impact of apathy on caregiving in hd. version 1

Conditions: Huntington Disease

Summary: huntington's disease (hd) can affect motivation. people with hd may not wash often, keep their house clean and tidy, or eating healthy food. this loss of motivation, or apathy, can also affect the way they talk to people and how willing they are to be in social situations. there are thought to be four different subtypes of apathy. these include reduced (1) motivation for planning and organising, (2) emotional reactions, (3) thoughts and actions and (4) social interaction. it is clear from talking to patients and their families in clinic that apathy has a big impact. it is often a source of distress for the people around the patient, who are trying to support and care for them. we know from previous research, that having good social support helps people with huntington's disease to live independently for longer. this research aims to understand the ways in which apathy can impact the levels of burden felt by caregivers of people with hd. caregivers will be asked to take part in a single interview. they will be asked questions about caring for someone with apathy. there will also be the opportunity to share their own first-hand experiences. these interviews will be analysed for common themes using framework analysis. attention will be given to the relationship between burden and the different types of apathy. understanding the factors that lead to increased caregiver burden is the first step towards finding way to support caregivers of people with hd.


Eligibility criteria:
inclusion criteria: participants will be included in the study if: * they hold significant caring responsibilities for someone with clinically manifest hd * the person they care for scores above the abnormality cut-off determined for hd on one or more subscale of the dimensional apathy scale - companion version, or the proposed clinical cut-off for the apathy motivational index - companion. * they are 18 years or older and able to give valid, informed consent for study participation. exclusion criteria: individuals will be excluded from the study is they: * have a lack of spoken english, sufficient to affect their understanding of the interview questions or compromise their ability to express their opinions. * did not consent to the interview being recorded.
validating interventions for diverse adolescents

Conditions: Substance-Related Disorders

Summary: the purpose of this study is to compare a culturally adapted and a non-culturally adapted group-based substance abuse treatment with latino adolescents.


Eligibility criteria:
inclusion criteria: * adolescent between 13-18 years of age * parental consent * adolescent speaks english and spanish * adolescent assent to participate in treatment and assessments * adolescent meets either dsm-iv diagnostic criteria for substance abuse or dependence * adolescent identifies as hispanic exclusion criteria: * adolescent younger than 13 or older than 18 years of age * adolescent requires higher level of care than what is provided in study * adolescent speaks only english or spanish * parental consent not obtainable * adolescent does not assent to study * adolescent is overtly psychotic, severely depressed/suicidal, and/or presents with other mental disorder that will limit participation in group treatment * adolescent has completed substance abuse treatment elsewhere in the past 90 days * adolescent does not identify as hispanic

Keywords: substance abuse substance addiction
the application of ursodeoxycholic acid for the prevention of sars-cov-2 infection (covid-19)

Conditions: COVID-19

Summary: evaluation of the efficacy and safety of ursodeoxycholic acid in blocking the transmission of infectious novel coronaviruses in a population of medical workers

this is a single-center, open-ended, single-arm clinical study to evaluate the effectiveness of daily ursodeoxycholic acid plus routine protective measures for the prevention of novel coronavirus infection. the target sample size is 130 medical workers and each healthy volunteer will be followed weekly for nucleic acid/antigen testing or disease progression over an 8-week period for new crown infections.

Eligibility criteria:
inclusion criteria: 1. age 18 - 65 years old. 2. no restriction on gender. 3. medical-related personnel (working hours \>20 hours per week) serving during the covid-19 outbreak, including physicians, nurses, medical technicians, administrators, and medical students 4. covid-19 nucleic acid test negative within 48 hours 5. sign the informed consent form exclusion criteria: 1. exhibit covid-19 symptoms, including fever, muscle pain, headache, cough, sore throat, and loss of smell and taste 2. previous infection with novel coronavirus within 6 months 3. previous (past 30 days), current or planned (during the study period) use of immunomodulatory-related drugs 4. those with allergy or intolerance to ursodeoxycholic acid, gallbladder or bile duct disease, severe liver failure, or liver function impairment 5. pregnancy and lactation 6. use of drugs with which ursodeoxycholic acid is contraindicated 7. other reported health conditions that make participation in the study not in the best interest of the individual

Keywords: ursodeoxycholic acid covid-19 prevention
single fraction preoperative radiotherapy for early stage breast cancer

Conditions: Breast Cancer

Summary: this is a phase i/ii, single-arm and open-label single-centre clinical trial with the aim to test the feasibility, safety and the efficacy, in terms of complete pathological response, of preoperative ablative radiotherapy in single fraction for selected breast cancer patients.

the research plan is conceived in two sections, as follows. (i)the technical study handles the set-up, motion and dosimetric issues of the radioablation technique using cyberknife system. (ii)the clinical section is organized in two studies: a phase i dose escalation study to identify the maximum tolerated dose (mtd) delivering 18 gy, 21 gy and 24 gy in single fraction and a phase ii study to evaluate the rate of pathological complete response (pcr) when a dose level is chosen according to the results of the previous phase i study. study population includes patients affected by ct1-t2 (up to 2.5 cm) cn0, adenocarcinoma of the breast, diagnosed with conventional workup. surgical tumor removal will be scheduled after 4-8 weeks after radioablation. whole breast radiation therapy without boost will be performed after surgery.

Eligibility criteria:
inclusion criteria: * histologically proven unifocal adenocarcinoma * t1-t2 * tumor size up to 2.5 cm * cn0 * age ≥ 18 years old * good general condition (ecog 0-2) * planned bcs * written informed consent exclusion criteria: * tumor close to skin or chest wall * pure non-invasive tumor * prior rt to the chest * neoadjuvant chemotherapy * collagenopathies * coagulation or autoimmunitary disorders * previous malignancies

Keywords: preoperative radiotherapy radiosurgery
the effect of transcutaneous electrical nerve stimulation on pain during propofol injection

Conditions: Transcutaneous Electrical Nerve Stimulation; Pain; Propofol Adverse Reaction

Summary: propofol, an intravenous sedative agent, frequently produces pain during injection. this study was designed to investigate whether transcutaneous electrical nerve stimulation could reduce pain during propofol injection. in minimizing propofol injection pain.

twenty min after transcutaneous electrical nerve stimulation, the electrodes were removed and propofol 0.5 mg/kg was administered at the rate of 0.5 ml/sec using syringe pump. propofol injection pain was evaluated by a study blinded anesthesiologist using a four point scale: 0=no (negative response to questioning), 1=mild pain (pain reported only in response to questioning without any behavioral sings), 2=moderate pain (pain reported in response to questioning and accompanied by a behavioral signs or pain reported spontaneously without questioning, 3=severe pain (strong vocal response or response accompanied by facial grimacing, arm withdrawal or tears).

Eligibility criteria:
inclusion criteria: - exclusion criteria: * american society of anesthesiologists physical status classification \> 3 * patient with a history of allergy to drugs * patient who takes opioid, sedative, anticonvulsant * patient with a history of neurologic disease and psychological disorders * patient with skin problem * patient with pacemaker or electric medical device * pregnancy
perioperative glucocorticoid administration in the treatment of adult distal radius fractures

Conditions: Distal Radius Fracture

Summary: the purpose of this investigation is to compare functional outcome measures and range of motion for patients receiving glucocorticoid (gc) injections versus those not receiving gcs for the treatment of distal radius fractures. the investigators hypothesize that patients who receive gc will have improved rom and functional outcome measures compared to patients who do not receive gc. in addition, this study aims to determine if there is a difference in rates of complications and postoperative pain control between the gc and non-gc groups. in order to accomplish these aims, the investigators will conduct a prospective, randomized, controlled investigation.


Eligibility criteria:
inclusion criteria: * patient 18 years of age and older. * patients undergoing orif with vp fixation of an acute, isolated drf with or without associated distal ulna fracture and with or without associated carpal tunnel release exclusion criteria: * worker's compensation patient * non-operatively treated fractures * open fractures * preoperative neurovascular injury * coexisting fractures or injuries * diabetes mellitus * allergy or contraindication to gcs * associated non-orthopedic injury that would prohibit the administration of gcs * patients currently incarcerated * pregnant patients
taste evaluation of different liquid formulations with eliglustat

Conditions: Gaucher Disease

Summary: primary objective: the purpose of this study is to assess the palatability of eliglustat prototype liquid formulations in healthy subjects.

the total duration of the study for each subject will be approximately 5 weeks (screening period from day -28 to day -2, treatment period of 3 days, and follow-up call on day 5).

Eligibility criteria:
inclusion criteria : * healthy male and female subjects, 18 to 55 years of age, inclusive. * normal smell and taste ability to discriminate odor and flavor differences. exclusion criteria: * poor metabolizer phenotype status for cyp2d6 (predicted based on genotype). * subject who has smoked within 3 months of inclusion. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
bo and do in women with cystocele before and after cystocele repair

Conditions: Bladder Oversensitivity; Detrusor, Overactive

Summary: the changes of lower urinary tract function after cystocele repair are important for perioperative consultation and management. thus, the aim of this retrospective study was to evaluate the prevalence of bladder oversensitivity and detrusor overactivity in women with ≥ stage ii cystocele and the changes of storage function after cystocele repair.

bladder oversensitivity and detrusor overactivity are two important diagnosis of urodynamic study regarding storage function of bladder. between november 2010 and october 2020, all women with ≥ stage ii cystocele who visited the urogynecological department of a medical center for cystocele repair were reviewed. those women who had complete data of preoperative and postoperative 3-month follow-up urodynamic data were excluded from this study. bladder oversensitivity was diagnosed if the volume of strong desire was less than 300ml. detrusor overactivity was defined as the occurrence of involuntary detrusor contractions during filling cytometry. stata software was used for statistical analysis. chi2 test, univariate and multivariable logistic regression tests were used for statistical analysis as appropriate. a p \< 0.05 was considered as statistically significant.

Eligibility criteria:
inclusion criteria: * women with ≥ stage ii cystocele * received cystocele repair * complete urodynamic study before and after surgery exclusion criteria: * recurrent cystocele after repairment * incomplete data * chronic infection

Keywords: bladder oversensitivity detrusor overactivity cystocele
cardiovascular and endothelial markers during ogtt before and at six and twelve months post-treatment in women with pcos

Conditions: PCOS; Hyperinsulinism; Hyperandrogenism; Metabolic Syndrome

Summary: the aim of the present study is to investigate a) the presence of subclinical markers of vascular, myocardial and endothelial function in women with pcos b) the acute alterations in these markers during the oral glucose tolerance test (ogtt) c) the impact of potential treatment interventions in these markers.

all the woman who will recruited in the study will undergo ogtt. at 0, 60, and 120 min of glucose load the investigators will measure: a) glucose and insulin, b) pulse wave velocity (pwv) c) augmentation index (aix) and d) perfused boundary region of sublingual microvessels (high pbr values represent reduced glycocalyx thickness). at 0 and 120 min of glucose load, the investigators will assess: a) coronary flow reserve (cfr) using doppler echocardiography, b) lv longitudinal strain (ls) of subendocardial, mid-myocardial and subepicardial layers and global ls (gls) c) peak twisting (ptw), untwisting velocity (putwvel) by speckle tracking echocardiography d) flow mediated dilation (fmd) of the brachial artery, e) carotid intima-media thickness. matsuda index, insulin sensitivity index (isi) and homa index will be also measured. the levels of testosterone (τesto), sex hormone binding globulin (shbg), dehydroepiandrosterone sulfate (dhea-s), prolactin (prl), 17-hydroxyprogesterone (17-oh-prg) ,androstenedione (δ4) and metalloproteinase 9 will be also assessed. after six months of treatment intervention, the patient will undergo the previously described measurements. primary endpoints include the change in gls, pwv, and pbr during ogtt and six months after treatment intervention. secondary endpoints include the change in cfr and fmd during ogtt and six months after treatment intervention.

Eligibility criteria:
inclusion criteria: 1. age \> 16 years old 2. diagonis of pcos according to rotterdam criteria: presence of two of the three of the following: * clinical or biochemical hyperandrogenism * anovulation or oligo-ovulation * polycystic ovarian morphology (pcom) 3. absence of treatment for pcos the last six months 4. patients who have the ability to understand and sign the consent form. exclusion criteria: 1. disorders with clinical presentation similar to pcos: thyroid disease, hyperprolactinemia, and non-classic congenital adrenal hyperplasia (primarily 21-hydroxylase deficiency by serum 17-hydroxyprogesterone \[17-ohp\]), cushing syndrome, acromegaly 2. treatment with contraceptive or metformin 3. type 2 diabetes mellitus 4. treatment for diabetes 5. pregnancy 6. lactation 7. malignancy
pilot trial to assess the feasibility of implementing objective parameters in patients affected by knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: pilot, open non-controlled trial to assess the feasibility of implementing objective parameters as primary endpoints in a clinical trial with patients affected by knee osteoarthritis.

• to assess the feasibility of implementing ultrasonography and range of motion (rom) as objective measurements to correlate the improvement of the knee mobility with the pain reduction of the affected knee in the patients assuming nutraceutical containing ha. the secondary objectives of the trial are: * to assess the feasibility of implementing actigraphy as objective measurements to correlate the improvement of the knee mobility with the pain reduction (optional). * to evaluate the enrollment range in one month. the explorative objectives of the trial are: • preliminary data on efficacy of the tested product

Eligibility criteria:
inclusion criteria: * any gender and age from 50 to 70 years * symptomatic osteoarthritis (oa) of the knee with mild joint discomfort for at least 6 months prior to enrollment, following acr criteria with history and physical examination (1). subjects diagnosed with bilateral knee oa will be asked to specify the most affected knee at baseline, and this knee will be evaluated throughout the study period. * available confirmatory x-ray (performed within the previous 6 months) diagnosis (kellgren/lawrence score 2) at the evaluated knee joint (2). * subjects experienced pain for at least 15 of the 30 days prior to the start of the study. exclusion criteria: * subjects who have any inflammatory arthritic condition (different from the oa of the knee), fibromyalgia, multiple sclerosis or autoimmune disorder. * treatment with oral corticosteroids within 4 weeks before screening. * intra-articular injections of ha or corticosteroids in the target joint within 3 months before screening. * treatment with anti-inflammatory or chondroprotective drugs (chondroitin sulfate, glucosamine, methylsulfonylmethane, ha, diacerein) 2 weeks before the selection. * ha-containing nutritional supplements or cosmetics during the month before the study. * previous surgical treatment of knee joint(s) or its necessity; complication(s) necessary for hospitalization and surgical treatment. * significant injury to the target joint within the past 6 months prior to screening (identified from medical history). * subjects following an energy-restricted diet for weight loss. * pregnant women, nursing mothers, or women (only if childbearing potential) not using adequate methods of contraception. * subjects with cardiovascular, hepatic, renal, respiratory, or hematologic illness, or other medical or psychiatric condition that, in the opinion of the investigator, would compromise participation or be likely to lead to hospitalization during the course of the study. * participation in an interventional clinical study in the previous 30 days. * presence of any clinically significant medical condition judged by the investigator to preclude the patient's inclusion in the study.
intravenous vs oral analgesia in cancer patients with severe pain after successful titration

Conditions: Cancer Pain

Summary: pain is one of the most common and fear symptoms for cancer patients, which seriously affects the quality of life in cancer patients. at present, oral opioid is the most common route to administrate cancer pain. however, the patients do not satisfy the pain administration with oral opioid after successful titration in many cases, especially the cases with severe cancer pain. patient controlled analgesia (pca) with hydromorphone can take analgesic effect rapidly. the aim of this trial is to compare the maintenance with hydromorphone pca intravenously or switch to sustained-release morphine orally after successful titraton with hydromorphone pca intravenously in severe cancer pain.


Eligibility criteria:
inclusion criteria: 1. the patients were 18-80 years old and diagnosed as malignant tumor by pathology; 2. patients with cancer pain is nrs pain score ≥ 7 during previous 24 hours; 3. patients who will not be treated with radiotherapy within 7 days prior to randomization and during study ; 4. patients who need chemotherapy, long term administration of hormone, targeted therapy, or bisphosphonates therapy should undergo a stable anti- tumor therapy prior to randomization ; 5. patients or his/her caregivers who are able to fill out the questionnaire forms ; 6. ability to correctly understand and cooperate with medication guidance of doctors and nurses ; 7. without psychiatric problems; 8. ecog performance status ≤3; 9. not participated in another drug clinical trial within one month before inclusion（including hydromorphone）; 10. the subjects voluntarily signed the informed consent. exclusion criteria: 1. the pain is confirmed not due to cancer; 2. patients with severe post-operative pain; 3. patients with paralytic ileus; 4. patients with brain metastasis; 5. patients hypersensitive to opioids; 6. patients with abnormal lab results that have obvious clinical significance, such as creatine ≥ 2 fold of upper limit of normal value, alanine aminotransferase (alt) or aspartate aminotransferase (ast) ≥ 2.5 fold of upper limit of normal value, or liver function of child c grade; 7. patients who cannot take drugs orally; 8. patients with an incoercible nausea or vomiting; 9. those who have received monoamine oxidase inhibitor (maoi) within two weeks before randomization; 10. patients who are pregnant or in lactation, or who plan to be pregnant within one month after the trial; 11. those with opioid addiction; 12. alcoholic patients; 13. those with cognitive dysfunction; 14. those with severe depression; 15. patients with other conditions or reasons causing the patients unable to complete the clinical trial.

Keywords: orally pca intravenously analgesia severe cancer pain
a long term study to assess the safety of fostamatinib in patients in asia with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the purpose of this study is to evaluate the long term safety and tolerability of fostamatinib in patients in asia with rheumatoid arthritis (ra).

(oskira-asia-1x): a long-term study to assess the safety of fostamatinib in the treatment of rheumatoid arthritis in asia

Eligibility criteria:
inclusion criteria: * provision of informed consent prior to any study-specific procedures. * patients who have successfully completed study d4300c00008 and whose disease is adequately controlled, in the opinion of the investigator. exclusion criteria: * premature withdrawal from study d4300c00008 or in the opinion of the investigator the patient's disease is not adequately controlled on current treatment. * development of any of the withdrawal criteria from study d4300c00008 * females who are pregnant or breast feeding * any other clinically significant disease or disorder, which in the opinion of the investigator might put the patient at risk due to participation in the study, or may influence the results of the study

Keywords: rheumatoid arthritis