Kornimate/medical-research-clean huggingface dataset:
a study to assess efficacy, safety, tolerability, and pharmacokinetics of abbv-8e12 in subjects with progressive supranuclear palsy (psp)

Conditions: Progressive Supranuclear Palsy

Summary: the purpose of this study was to assess efficacy, safety, tolerability, and pharmacokinetics of abbv-8e12 in participants with progressive supranuclear palsy (psp).

this was a phase 2, randomized, double-blind, placebo-controlled, multiple dose, multicenter study consisting of a screening period of up to 8 weeks (56 days), a 52-week double-blind treatment period, and a post-treatment follow-up period of approximately 20 weeks following last study drug administration (for those participants who prematurely discontinued from treatment, declined to participate in or did not qualify for participation in a long term extension \[lte\] study). at the end of the treatment period, extended treatment was available for eligible participants who completed the 52-week treatment period and entered the separate long-term extension study (nct03391765; study m15-563). there were 3 cohorts in the study (cohort 1, cohort j1, and cohort 2). cohort 1 had augmented safety and pharmacokinetic (pk) assessments in the first 30 participants enrolled into the global study from countries other than japan. cohort j1 had augmented safety and pk assessments in the first 9 participants enrolled into the study from japan. cohort 2 consisted of all other participants enrolled in the global study not participating in cohort 1 or cohort j1. this study was prematurely discontinued because the program for progressive supranuclear palsy was discontinued due to lack of efficacy of study drug.

Eligibility criteria:
key inclusion criteria: * male or female participant with age 40 years or greater at the time of signed consent * meets the criteria for possible or probable progressive supranuclear palsy (psp; steele-richardson-olszewski syndrome) * presence of psp symptoms for less than 5 years * participant is able to walk 5 steps with minimal assistance (stabilization of one arm or use of cane/walker) * participant has an identified, reliable, study partner (e.g., caregiver, family member, social worker, or friend) key exclusion criteria: * participants who weigh less than 44 kg (97 lbs) at screening * mini-mental state examination (mmse) score less than 15 at screening * any contraindication or inability to tolerate brain magnetic resonance imaging (mri) * participant resides at a skilled nursing or dementia care facility, or admission to such a facility is planned during the study period * evidence of any clinically significant neurological disorder other than psp * the participant has a history of or currently has schizophrenia, schizoaffective disorder or bipolar disorder according to diagnostic and statistical manual of mental disorders, 5th edition (dsm-v) or international classification of diseases (icd-10) criteria * participant has had a significant illness or infection requiring medical intervention in the past 30 days

Keywords: psp steele-richardson-olszewski syndrome tauopathy
rapid on site evaluation of pleural touch preparations in diagnosing malignant pleural effusion in patients undergoing pleuroscopy

Conditions: Malignant Neoplasm; Malignant Respiratory Tract Neoplasm; Malignant Thoracic Neoplasm

Summary: this trial studies how well rapid on site evaluation of pleural touch preparations works in diagnosing cancerous fluid in between the linings of the lungs (malignant pleural effusion) in patients undergoing a pleuroscopy. a type of laboratory testing called rapid on site evaluation of pleural touch preparations that uses pleural biopsy tissue samples collected during an already-scheduled pleuroscopy may be able to diagnose malignant pleural effusion.

primary objectives: i. to estimate the specificity of rapid on site evaluation (rose) of touch preparations (preps) for predicting malignancy on final pathology in pleuroscopy. secondary objectives: i. to estimate the sensitivity of rapid on site evaluation (rose) of touch preparations (preps) for predicting malignancy on final pathology in pleuroscopy. ii. to estimate the specificity and sensitivity of visual assessment of pleura for predicting malignancy on final pathology in pleuroscopy. iii. to compare the specificity and sensitivity of rose of touch preps between centers. outline: patients undergo biopsy of the lining of the lung using pleuroscopy. medical chart of patients is also reviewed.

Eligibility criteria:
inclusion criteria: * patients who will undergo pleuroscopy with biopsy exclusion criteria: * patients with known malignant pleural effusion * inability or unwillingness to give informed consent
a behavioral intervention for pain catastrophizing in primary dysmenorrhea

Conditions: Pain Catastrophizing; Primary Dysmenorrhea

Summary: the purpose of this study is to test the feasibility and efficacy of a brief group therapy treatment program focused on reducing pain catastrophizing in adolescents and young adults (ages 16-25) with menstrual pain.


Eligibility criteria:
inclusion criteria: * female ages 16-25 years * self-reported menstrual cycle averaging 24-32 days * menstrual pain rating of ≥4 on the numeric rating scale for at least the previous three menstrual cycles prior to participation * written informed consent or assent (if a minor, parent must also provide written parental permission) * able to read and understand english exclusion criteria: * use of oral contraceptives or any exogenous hormones in the previous 3 months * presence of persistent pelvic pain throughout the menstrual cycle * acute illness or injury that may impact lab performance or that affects sensitivity of the extremities * diagnosis of an underlying medical cause for dysmenorrhea symptoms * no or minimal menstrual pain (nrs rating of ≤ 3) during any of the 3 previous cycles prior to study participation * daily use of opioids; participants using other analgesics will be included, but will be asked not to take these analgesics on the days of the lab sessions * developmental delay, autism, or significant anatomic impairment that may preclude understanding of study procedures

Keywords: cognitive behavioral therapy laboratory pain responsivity
characterisation and epidemiology of breakthrough cancer pain in spain

Conditions: Breakthrough Cancer Pain

Summary: the purpose of this study is to determine the prevalence of breakthrough cancer pain and characterize breakthrough cancer pain in an unselected, representative cohort of cancer outpatients with or without pain who attend consultations.

this study has been designed as a non-interventional, non post-authorization, cross-sectional, epidemiological study to determine the prevalence of breakthrough cancer pain and characterize breakthrough cancer pain in an non-selected, representative cohort of cancer outpatients with or without pain. the study enrolled 3765 patients. this multicenter trial will be conducted in spain. data from participants will be collected through questionnaire and medical history in a single visit (up to 1 month).

Eligibility criteria:
inclusion criteria: * participants≥ 18 years old * participants with baseline cancer pain that is adequately controlled with opioids * presence of episodes of breakthrough pain associated with the cancer pain * meeting the diagnostic criteria for breakthrough cancer pain (participant history and portenoy's criteria) and the davies algorithm * participants who are not receiving treatment for breakthrough cancer pain. it is not permitted the inclusion of participants receiving treatment for breakthrough cancer pain in order to avoid bias that may affect the characterization or taxonomy of breakthrough cancer pain * signing of the informed consent exclusion criteria: * severe mental illness * any medical condition or situation complicating the collection of study data as determined by the investigator

Keywords: drug therapy
ferric carboxymaltose to improve skeletal muscle metabolism in heart failure patients with functional iron deficiency

Conditions: Iron-deficiency

Summary: the purpose of this study is to better understand how body levels of iron affect the ability to exercise in patients with heart failure (hf). heart failure is a condition in which abnormal pumping action of the heart reduces the flow of blood to the body. patients with heart failure may feel shortness of breath or leg fatigue when they exercise. iron is an essential nutrient in the diet. in heart failure patients, low body levels of iron might increase shortness of breath and fatigue.

the purpose of this prospective, double blind parallel group randomized study is to compare the effects of ferric carboxymaltose vs. placebo on skeletal muscle mitochondrial oxidative capacity, submaximal exercise tolerance, and health-related quality of life in non-anemic heart failure (hf) patients with functional iron deficiency.

Eligibility criteria:
inclusion criteria: * symptomatic nyha class ii-iii heart failure \>3 months * guideline-recommended heart failure treatment for \> 3 months * hemoglobin \>13 g/dl for men and \>12 g/dl for women * functional iron deficiency (defined as serum ferritin level \<100 ng/ml or between 100 and 299 ng/ml with transferrin saturation \<20%) * left ventricular ejection fraction \ 28 ml/m2) and/or left ventricular hypertrophy (left ventricular mass index \>95 g/m2 (women) or \>115 g/m2 (men) determined by echocardiogram within last 24 months. * able and willing to provide written informed consent exclusion criteria: * presence of implantable defibrillator, permanent pacemaker, other metal implant not compatible with 3tmrs/mri, or other contraindication to 3t mrs/mri procedures * heart failure due to infiltrative cardiomyopathy, restrictive cardiomyopathy, or hypertrophic cardiomyopathy * weight \ 120 kg * coronary or cerebral atherothrombotic events in the past 6 months * hospitalization of emergency room visit for heart failure within past 3 months * icd shock in last 3 months * known peripheral artery disease or ankle-brachial index \<0.9 at screening visit * exercise primarily limited by angina, lung disease or neuromuscular disease * systolic blood pressure \ 160 mmhg * heart rate \ 110 min-1 * estimated glomerular filtration rate \<30 ml/min * liver function tests \>3 times upper limit of normal * serum phosphate below normal limit * pregnant or breast-feeding women * women of child-bearing potential unwilling to use recommended contraception methods during the study * treatment with oral iron supplements (except multivitamins) in past year * treatment with intravenous iron in past year * treatment with erythropoiesis stimulating agents in the past year * known intolerance of intravenous iron * history of anaphylaxis * participation in another clinical trial within last 30 days.

Keywords: injectafer ferric carboxymaltose supplemental iron
effect of pioglitazone on cardiovascular outcome on higashi-saitama trial in patients with type 2 diabetes

Conditions: Type 2 Diabetes; Hypertension; Dyslipidemia; Diabetic Nephropathy

Summary: we want to investigate the effects of pioglitazone on cardiovascular events in japanese patients with type 2 diabetes.

primary composite endpoints: cardiovascular death non-fatal myocardial infarction and angina non-fatal stroke renal failure (hemodialysis/doubling of serum creatinine) secondary endpoints: urinary albumin excretion diabetic retinopathy hyperlipidemia hypertension gout

Eligibility criteria:
inclusion criteria: * type 2 diabetes hba1c: more than 7% and less than 9% exclusion criteria: * insulin treatment
effectiveness of an interventional intervention in improving the work environment of nurses and nursing assistants in the hospital

Conditions: Healthy Work Environment; Burnout; Intention to Leave; Engagement

Summary: the goal of this interventional study is to evaluate the effectiveness of a training course on a healthy work environment for nurses and nursing assistants in a hospital. the main questions it aims to answer are: * to evaluate the effectiveness of a training course on a healthy work environment * to know the perception of nursing and nursing assistants on what is needed to have a healthy work environment, what elements it should contain and whether it has changed after the course has been completed participants in the intervention group will receive the training course and the control group will not. researchers will compare intervention group with control group to see if the training course on healthy work environment is effective.

concurrent mixed study consisting of different phases in which the qualitative and quantitative parts will be interspersed. the qualitative part will include focus groups, and the quantitative part will be a controlled non-randomised experimental study by convenience sampling according to hospital unit and professional category (nurses and nursing assistants). multicenter study carried out at hospital general de granollers and the consorci sanitari de terrassa in nursing professionals and nursing assistants with one year of experience working in the hospital in any of the hospitalization services or special services. once the subjects have been included in the study, they will be assigned in each group (control group and intervention group) through a stratification by quotas following the same criteria as in the sampling. the intervention group will receive training (n=56), and the control group will not (n=112). the training will be based on the american association of critical care nurses standards on a healthy work environment. in both groups, the same data will be collected at different times (before and just after the training, at 6 months and 12 months post-training). the focus groups will not be conducted in the control group after the training. work environment, burnout, intention to leave the job and staff engagement will be assessed.

Eligibility criteria:
inclusion criteria: * voluntary acceptance to participate in the study * having worked at least one year in the hospital exclusion criteria: * nursing supervisors/nursing assistants or people with management positions * professionals working in more than one care center * professionals working in the outpatient area

Keywords: healthy work environment burnout intent to leave engagement educational intervention nursing
genotype-guided versus standard for warfarin dosing

Conditions: Atrial Fibrillation; Valvular Heart Disease

Summary: to compare the efficiency and safety between gene-oriented group and standard care group during 90 days of initial warfarin-treatment for requiring anticoagulation patients with valve replacement or atrial fibrillation with or without valvular heart disease。

due to narrow therapeutic window, and individual differences in dosage, inappropriate use of warfarin may lead to serious complications and ineffective. based on the results of the research on the transformation of warfarin pharmacogenomics, this study investigates the clinical application of gene-directed warfarin dose prediction model through the preset dosage regimen of warfarin during the initial treatment phase. compared with the conventional treatment, that is to say empirical medication, this study is to verify the feasibility and value of gene-oriented warfarin dose prediction model, in order to establish a practical guidance to optimize the rational use of warfarin treatment program, to enable patients to obtain effective, safe warfarin dose, and to achieve the established anticoagulant strength faster and safer, as the same time, to reduce the times of patients was blood and the incidence of bleeding/embolism, and to save costs and ensure the safety of warfarin clinical medication.

Eligibility criteria:
inclusion criteria: * patients aged from 18 to 70 years old, requiring anticoagulation because of valvular or non-valvular atrial fibrillation or after valvular replacement. patients could visit to be followed up in our hospital clinic regularly and agree to participate in the clinical trial and sign a written informed consent. exclusion criteria: * patients will be excluded from the trial if aged \ 75 years old, pregnant and lactating, if treated tricuspid valve replacement, or coronary artery bypass grafting before, if diagnosed with congenital heart disease, if known their cyp2c9 or vkorc1 genotype, if taken dicoumarol drugs previously or taking them now, if not suitable for enrollment judged by researchers.

Keywords: warfarin gene
masseter muscle thickness and craniofacial skeletal patterns

Conditions: Masseter; Ultrasonography; Malocclusions; Cephalometry

Summary: facial morphology is influenced by hard and soft tissues, including bone and muscle. while numerous factors can lead to changes in bone tissue, soft tissues such as muscle also have an important influence. it is widely acknowledged that the function, shape and thickness of masticatory muscles have substantial effects on facial morphology and skeletal development, and are correlate with other anthropometric variables. furthermore, a correlation has been observed between masseter muscle thickness and various characteristics of the dental arches, such as alveolar process thickness and intermaxillary width. the evaluation of soft tissue in the region of the face is a more challenging process in comparison to that of hard tissue.the recent development of cone beam computed tomography has improved the analysis of three-dimensional skeletal morphology and jaw. however, the radiographic assessment of soft tissue remains more difficult.the thickness of masticatory muscles can be measured using computerised tomography; however, this has the disadvantage of exposing the patient to radiation. magnetic resonance imaging (mri) is an imaging technique that can be used to assess soft tissues. however, this technique is expensive and time-consuming. furthermore, mri is a static rather than a dynamic imaging technique, which makes it difficult to analyse during muscle contraction and relaxation. ultrasound is a technique that provides dynamic imaging that can assess the masticatory muscles without the use of ionising radiation. there are many publications in the literature that indicate that malocclusions in the vertical and sagittal dimensions can be assessed with measurements from lateral cephalometric radiographs.


Eligibility criteria:
inclusion criteria: patients who * patients who were 18 years of age or older, * had skeletal malocclusion, * were systemically healthy, * were not taking any medication, * had no missing teeth except for the third molars, * had no history of congenital and/or acquired anomalies in the lips, mouth and facial regions, * had not received orthodontic treatment before exclusion criteria: patients who * were younger than 18 years of age * were with systemic disease, * used antidepressant drugs before, * has bruxism habit, * had orthodontic treatment or has active orthodontic treatment, * had history of trauma and surgery in the maxillofacial region

Keywords: masseter muscle malocclusion ultrasonography cephalometry maxillofacial development
comparison of subacromial ozone (o2-o3) and corticosteroid injections in the treatment of rotator cuff tendinopathy

Conditions: Rotator Cuff Tendinopathy

Summary: shoulder pain accounts for approximately 16% of all musculoskeletal symptoms. rotator cuff tendinopathy is the most common cause of shoulder pain. the aim of this study is to compare the effects of ultrasound-guided subacromial ozone (o2-o3) versus corticosteroid injection in patients with chronic rotator cuff tendinopathy.

shoulder pain accounts for approximately 16% of all musculoskeletal symptoms. rotator cuff tendinopathy is the most common cause of shoulder pain. there are limited studies comparing the efficacy of ozone and corticosteroid injections in rotator cuff tendinopathy. in this context, the aim of this study is to compare the effects of ultrasound-guided subacromial ozone (o2-o3) versus corticosteroid injection in patients with chronic rotator cuff tendinopathy.

Eligibility criteria:
inclusion criteria: * aged between 18 and 70 years * pain in the shoulder region and increase in pain with overhead-throwing activity * chronic shoulder pain for more than 3 months * partial rotator cuff tear or rotator cuff tendinosis diagnosed by us or magnetic resonance imaging (mri). exclusion criteria: * a full-thickness rotator cuff tear diagnosed by us or mri * allergic reaction betamethasone or lidocaine * contraindications for ozone (o2-o3) injection, such as uncontrolled hyperthyroidism, glucose-6 phosphate dehydrogenase deficiency (g6pdd), pregnancy and platelet level \<50 103/µl * history of coagulopathy, diabetes, or hepatitis * intra-articular/subacromial injections in the last 3 months * history of shoulder infection, fracture, trauma, bony lesion, tumor or inflammatory rheumatic diseases * history of brachial plexus lesion/cervical radiculopathy.

Keywords: rotator cuff tendinopathy ozone steroid ultrasonography
viome precision nutritional programs to improve clinical outcomes for mental health conditions

Conditions: Mental Health Issue; Mental Health Disorder; Mental Health; Depression; Depression, Anxiety; Anxiety; Anxiety Disorders; Anxiety Depression; Anxiety State

Summary: us residents who have obesity and sign the informed consent form and are screened and enrolled for this study. participants who are enrolled complete a survey upon enrollment and are randomized into one of two arms. this study is direct to participant and will not utilize clinical sites.

participants who meet the eligibility criteria are randomized into any of the two arms including: the placebo arm or the viome precision nutrition program (vpnp) arm. placebo and viome's precision nutrition program include supplements and/or dietary recommendations towards improving the symptoms associated with metabolic wellness. the trial will last approximately 4 months for each participant.

Eligibility criteria:
inclusion criteria: * resident of the united states * 50 years old and older or bmi of 25 or greater * able to speak and read english * no unexplained weight loss, fevers, anemia, or blood in stool * willing and able to follow the trial instructions, as described in the recruitment letter * signed and dated informed consent prior to any trial-specific procedures. * phq9 score of 5-24 (inclusive) exclusion criteria: * unwilling to change their current diet * prior use of viome products or services * antibiotic use in the previous 4 weeks * pregnancy (current or planned in the next 4 months) * \< 90 days postpartum * breast feeding * active infection * unable or unwilling to use viome's app on an iphone or android smartphone * significant diet or lifestyle change in the previous 1 month * ibd diagnosis -major psychiatric/dsm-4 disease diagnosis (e.g. schizophrenia, bipolar disorder, post- traumatic stress disorder, obsessive compulsive disorder) * use of investigational drugs, products or devices within 1 month prior to and 4 months after the start of the trial * cancer therapy within the previous 1 year * major surgery in the last 6 months or planned in the next 4 months * allergies to any supplement ingredients listed in the screening survey * currently on a specific diet: fodmap, keto, paleo * answered yes to the question, "in the past few weeks, have you wished you were dead or had thoughts about killing yourself?" * gastrointestinal disease including: * gi surgery except: * appendectomy and benign polypectomy * esophagitis * celiac disease * gi malignancy or obstruction * peptic ulcer disease * duodenal or gastric ulcer disease

Keywords: mental health diet supplements vitamins stress
effects of physical activity on the brain in parkinson's disease (pd)

Conditions: Parkinson's Disease

Summary: the aim of the study is to investigate whether exercise improves cognitive and motor functions in parkinson's disease. to test this hypothesis, the researchers study general brain functions in subjects with pd during a 6-months exercise program.


Eligibility criteria:
inclusion criteria: * updrs \<15 * l-dopa responsive * \<5 yrs since diagnosis exclusion criteria: * severe other diseases * mmse \< 26 * treatment with psychiatric medication