Kornimate/medical-research-clean huggingface dataset:
safety and efficacy of fidaxomicin versus placebo for prophylaxis against clostridium difficile-associated diarrhea in adults undergoing hematopoietic stem cell transplantation (mk-5119-001)

Conditions: Clostridium Difficile-Associated Diarrhea (CDAD)

Summary: the objective of this study is to demonstrate the efficacy and safety of fidaxomicin versus placebo for prophylaxis against clostridium difficile-associated diarrhea (cdad) in adult participants undergoing hematopoietic stem cell transplantation (hsct). the primary hypothesis is that fidaxomicin is superior to placebo in preventing cdad in participants undergoing hsct.


Eligibility criteria:
inclusion criteria: * male or female 18 years of age or older. * females of childbearing potential must be using an adequate and reliable method of contraception (e.g., abstinence, barrier with additional spermicide foam or jelly, intrauterine device, hormonal contraception). males and females must agree to avoid conception during treatment and for four weeks following the end of study treatment. * is undergoing hsct with planned fluoroquinolone prophylaxis. * informed consent is provided. exclusion criteria: * ongoing active cdad infection (as evidenced by clinical signs of diarrhea along with the presence of either toxin a and/or b \[or their respective genes, tcda and/or tcdb\] of c. difficile in the stool) or current treatment for cdad. * undergoing cord blood transplants. * has fulminant colitis, toxic megacolon, or ileus. * a history of inflammatory bowel disease (ulcerative colitis or crohn's disease). * women who are pregnant or are actively breast feeding (all women of childbearing potential must have a negative pregnancy test result prior to dosing study drug). * use of any drugs potentially useful in the treatment of cdad (e.g. oral vancomycin, metronidazole, oral bacitracin, fusidic acid, rifaximin, and nitazoxanide). * any other condition that, in the opinion of the investigator, would jeopardize the safety or rights of the participant in the study, would make it unlikely for the participant to complete the study, or would confound the results of the study. * participation in other clinical research studies utilizing an investigational agent within one month prior to screening and during the study treatment period.

Keywords: clostridium difficile clostridium difficile-associated diarrhea prophylaxis hematopoietic stem cell transplantation
increasing psychological resilience in combat soldiers applying advanced eye-tracking-based attention bias modification

Conditions: PTSD; Depression; Anxiety Disorders

Summary: military service in combat units entails exposure to traumatic events that require mental adjustment. to develop and efficiently apply attention bias modification interventions aimed at enhancing soldiers' mental resilience, it is essential to test the efficiency of such training programs in rcts. the purpose of the current study is to examine the efficiency of a new attention eye-tracking-based training protocol, in comparison to an rt-based training protocol, and to a control group, in reducing risk for post-trauma symptoms in combat deployed soldiers.

following the explanation to participants regarding the study process, those who give written consent to participate will be randomly placed into one of three groups: gcft (n=180), abmt (n=180), and a neutral control group - rt-based task (n=180). the study will include 3 measurement points: before attention training (in basic training before deployment), after attention training (in basic training camp, still before deployment), and after a combat deployment cycle (6-12 months - to be determined based on the military deployment mission of the participants). in each measurement point, the participants will complete computerized tasks to measure attention and will complete self-report questionnaires.

Eligibility criteria:
inclusion criteria: * each soldier from the allocated cohort who gives written consent will be able to participate in the study. exclusion criteria: * hebrew proficiency is insufficient to complete the study questionnaires.

Keywords: attention bias modification eye-tracking randomized control trial
mt2022-01: mscs for ald

Conditions: Cerebral Adrenoleukodystrophy

Summary: this is a single-institution study to evaluate the use of intravenously administered allogeneic, 3rd party mesenchymal stem cells (iv-msc) in patients with active, cerebral adrenoleukodystrophy (cald), as a bridge to hematopoietic stem cell transplant or gene therapy, or in patients who are too advanced for gene therapy or hsct. the intervention will occur in the time between diagnosis of active cald and transplant which is currently 8-12 weeks.


Eligibility criteria:
inclusion criteria: * age ≥ 3 years * diagnosis of ald, as established by elevation of very long chain fatty acid levels or gene mutation * evidence of active cerebral disease as determined by the presence of gadolinium enhancement * ald mri (loes) score ≥ 1 * patients who have not received prior gene therapy or transplant * life expectancy of \> 6 months as determined by the enrolling researcher * have adequate organ function confirmed by laboratory values obtained within 28 days prior to enrollment exclusion criteria: * inability to undergo sedation or mri studies for any reason * other concurrent life-threatening disease (life expectancy \<6 months) or eligible for hospice care * known or suspected hypersensitivity to human serum albumin, diphenhydramine, acetaminophen, methylprednisolone, or any of the components of ims001.
sitz bath vs no sitz bath in acute anal fissure treatment

Conditions: Pain, Postoperative

Summary: to compare the efficacy of 'sitz bath' and 'no sitz bath' treatment in terms of pain improvement, rate of cure and fissure healing in acute anal fissure.

abstract objective to compare the efficacy of 'sitz bath' and 'no sitz bath' treatment in terms of pain improvement, rate of cure and fissure healing in acute anal fissure. study design randomized controlled trial place and duration of study department of surgery combined military hospital, quetta, from15 january 2019 to 15 august 2021. patients and methods individual patients were randomized to either receive 'sitz baths' or 'no sitz baths' treatment for 4 weeks. patients were asked to have 'sitz bath' once in morning and again at bedtime, after each week pain scores and healing of fissure were assessed. main outcome measures were validated. keywords acute anal fissure, pain, sitz bath

Eligibility criteria:
inclusion criteria: * patients of acute anal fissure of both genders between 18 to 60 years exclusion criteria: * while the patients with history of recurrent fissure, chronic anal fissure, pregnant woman and patients who were operated previously for any anorectal pathology were excluded from the study.

Keywords: acute anal fissure, pain, sitz bath
study of exercise and heart function in patients with heart failure and pulmonary vascular disease

Conditions: Exercise Tolerance; Dyspnea; Heart Failure; Pulmonary Hypertension

Summary: heart failure with preserved ejection fraction (hfpef) and pulmonary hypertension (ph) can be diagnosed noninvasively by exercise echocardiography (exe) and cardiopulmonary exercise testing (cpx) as compared with gold standard invasive hemodynamic assessment.

* the broad objective of this proposal is to characterize the dynamic changes in cardiopulmonary mechanics during stress in patients with exertional dyspnea, establishing a comprehensive multimodality diagnostic approach to the evaluation of exercise intolerance. * the specific objective is to prospectively compare established and novel parameters derived from echocardiography and cpx with simultaneous, gold standard invasive measures of cardiovascular hemodynamics at rest and with exercise stress to define the role of noninvasive testing in the diagnostic workup. * the primary hypothesis is that combined exe and cpx can noninvasively identify hfpef.

Eligibility criteria:
inclusion criteria: * exertional intolerance/dyspnea of unknown etiology * referral to cardiac catheterization laboratory * undergoing invasive hemodynamic evaluation for clinical purposes exclusion criteria: * hypertrophic cardiomyopathy * constrictive pericarditis * infiltrative myopathy (e.g. amyloid) * congenital heart disease * resting lvef \<50% * \> moderate mitral annular calcification * moderate or greater left-sided valvular stenosis or regurgitation * prior valve surgery * basal septal wall motion abnormalities * \>70% epicardial coronary artery stenosis * right ventricular infarction * pregnancy

Keywords: cardiac catheterization echocardiography
study of stim1 membrane expression

Conditions: Autoimmune Diseases

Summary: the aim of this study is to determine the expression of stim1 in the plasma membrane of lymphocytes from patients suffering from different autoimmune diseases in order to identify new pathologies of interest presenting an over-expression of stim1pm. this would allow to initiate, following this study, research and development programs on the use of anti-stim1 antibodies in these identified autoimmune diseases of interest.


Eligibility criteria:
inclusion criteria: * diagnosis of one of the autoimmune diseases exclusion criteria: * treatment with rituximab in the previous 12 months

Keywords: autoimmune diseases
outcomes after repair of acute rotator cuff tears

Conditions: Rotator Cuff Tear

Summary: few studies are considering acute traumatic rotator cuff tears in previously asymptomatic patients. the purpose of the current study was to investigate if delay of surgery, age at repair and the number of cuff tendons involved affected the structural and clinical outcomes.


Eligibility criteria:
inclusion criteria: * significant trauma to the shoulder * sudden onset of symptoms * asymptomatic in the shoulder before trauma * pseudoparalysis in the shoulder after trauma * full thickness rotator cuff tear of at least one tendon exclusion criteria: * patients with previous or gradual onset of symptoms in the traumatised shoulder * partial rotator cuff tear * displaced fracture

Keywords: rotator cuff tear rotator cuff repair age timing to surgery
multi-joint coordination underlies upright balance control in elderly with osteoporosis

Conditions: Osteoporosis

Summary: osteoporosis is a prevalent health concern among older adults and is associated with an increased risk of falls that can cause fracture, injury and even mortality. identifying the factors related to falls occur within this population is essential for the development of effective regimes for fall prevention. the long-term objectives of this work are to ascertain the mechanisms for effectively controlling balance in seniors with osteoporosis and to provide a basis for developing fall prevention programs. the entire body's center of mass (com) is a critical indicator for balance control and the coordination among joints and muscles to control the com is still unclear. the aim1 of this study is to develop biomechanical models that control the entire body's center of mass (com) during upright quiet stance in seniors with osteoporosis. the aim2 of this study is to identify the mechanism to control the entire body's com after receiving a balance perturbation in seniors with osteoporosis. the findings of this research can provide needed information regarding the processes of balance control in this vulnerable osteoporosis population, and has the potential to be applied to individuals with other neuromuscular and orthopedic deficits.


Eligibility criteria:
inclusion criteria: * for healthy older adults (oa) 1. can stand for 5 minutes and walk for 6 minutes independently 2. normal or corrected to normal vision 3. an age between 65-85 years 4. no osteoporosis (t-score above -2.5) * for osteoporosis participants (op) 1. can stand for 5 minutes and walk for 6 minutes independently 2. normal or corrected to normal vision 3. an age between 65-85 years 4. no osteoporosis (t-score below -2.5) exclusion criteria: 1. pregnant women 2. cancer diagnosis 3. sensory-motor deficits 4. the bmi is larger than 30 or smaller than 18

Keywords: to ascertain the mechanisms for effectively controlling balance in seniors with osteoporosis and to provide a basis for developing fall prevention programs. to develop biomechanical models that control the entire body's center of mass (com) during upright quiet stance in seniors with osteoporosis. to identify the mechanism to control the entire body's com after receiving a balance perturbation in seniors with osteoporosis.
carpal tunnel syndrome evaluation with ultrasound in rheumatoid arthritis patients

Conditions: Median Nerve Entrapment

Summary: in rheumatoid arthritis (ra) patients, the diagnosis of carpal tunnel syndrome (cts) was made based on clinical findings and physical examinations. then, the cross-sectional areas of the participants' median nerves from different levels were measured. meidolateral and anteroposterior diameter were measured at the level of the carpal tunnel inlet. flattening ratio was calculated. wrist to forearm ratio and wrist to forearm difference were calculated. the obtained data were compared between ra with cts, ra without cts and healthy control.


Eligibility criteria:
inclusion criteria: * ra patients identified according to the 2010 american college of rheumatology/europan leage against rheumatism classification criteria * healthy controls (hc) with no history of rheumatic diseases and cts. * individuals aged 18-65 years. exclusion criteria: * thoese with hypothyroidism, * gout, * diabetes mellitus, * history of cts surgery, * upper extremity plexopathy, * polinöropathy, * uncontrollable fibromyalgia, * steroid injection for cts * for the hc group, those with phalen or tinnel detected in at least one wrist and those with bifid median nerve detected during us evaluation were not included in the study.

Keywords: rheumatoid arthritis ultrasound carpal tunnel syndrome
safety and efficacy in premenopausal women with heavy menstrual bleeding (hmb) associated with uterine fibroids (uf)

Conditions: Heavy Uterine Bleeding; Uterine Fibroids

Summary: this is a phase 2b randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of elagolix alone and in combination with add-back therapy versus placebo on heavy menstrual bleeding in premenopausal women 18 to 51 years of age with uterine fibroids.


Eligibility criteria:
inclusion criteria: * subject is pre-menopausal female 18 to 51 years of age at screening. * subject has diagnosis of uterine fibroids documented by a pelvic ultrasound. * subject has heavy uterine bleeding associated with uterine fibroids. exclusion criteria: * subject has had a myomectomy, uterine artery embolization or high intensity focused ultrasound for fibroid destruction within 6 months prior to screening or endometrial ablation within 5 years prior to screening. * subject has a history of osteoporosis or other metabolic bone disease. * subject shows evidence of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric (including depression, schizophrenia, bipolar disorder), or neurologic diseases or any uncontrolled medical illness such as uncontrolled type 2 diabetes. subject has any history of attempted suicide. * subject has a history of clinically significant condition(s) including but not limited to: \* symptomatic endometriosis \* epilepsy or seizures \* type 1 diabetes \* chronic kidney disease \* any cancer (except treated basal cell carcinoma of the skin), including breast or ovarian cancer or subject has taken any systemic cancer chemotherapy

Keywords: uterine fibroids leiomyomata elagolix menorrhagia elagolix sodium heavy uterine bleeding abt-620
positional device aimed at patients with low back pain

Conditions: Low Back Pain

Summary: the project aims to idealize a pelvic suspension device as an auxiliary physiotherapeutic resource for patients with reduced mobility and functional capacity, which should favor autonomous and independent performance in personal, social and work tasks of the target population. this is a controlled clinical trial study. the research sample will be composed of patients of both sexes, aged 21 to 65 years, diagnosed with low back pain, referred to ueafto/uepa, through the sus care network. the research participants will be evaluated by posture, active mobility and muscle strength of the spine, evaluation of pain intensity and functional capacity. a device will be built with the function of keeping the user in position of pelvic suspension promoting lumbar traction that will consist of a structure of pvc pipes and connections and padded material. participants will be submitted to 10 sessions of use of the device, after which they will be reevaluated through the same procedures. the information collected will be analyzed through the graphpad prism software. to compare measured values, the shapiro-wilk test will be used for normality distribution. student's t-tests will be used for the treatment of variables with normal distribution, and fisher's and mann-whitney's exact tests for variables without normal distribution. it is expected to collaborate in the social integration, labor and quality of life of people affected by low back pain, as well as to promote the development of low-cost technologies in the routine of physiotherapy and public health in the state of pará.


Eligibility criteria:
inclusion criteria: * patients with low back pain exclusion criteria: * patients with a history of vertebral surgery * patients with spinal tumors * patients with intervertebral disc infections * patients with vertebral fractures * patients with severe osteoporosis * patients with ankylosing processes of the spine * patients with heart diseases
cognitive multi-tasking training in healthy older adults

Conditions: Age-related Cognitive Decline

Summary: this study evaluated the feasibility of a remote web-based ecological cognitive training protocol to healthy older adults. the training protocol involves 5 training sessions.

previous research demonstrated the relevance in training cognitive abilities that typically decline with age, such as those associated with executive control (e.g., abstract thinking, selective and divided attention, planning, task-switching and inhibitory control). the aim of the present study is to investigate the feasibility of a web-based cognitive training focused on executive control to cognitively healthy older adults. the participants will undergo the web-training in a daily type situation of meal preparation (i.e., breakfast game). the training protocol combines the tasks of table setting and cooking in a multi-tasking fashion. in some sessions emphasis change approach will be apply to the training, in order to assess it feasibility and potential effects in optimizing the performance. in addition, participants will undergo a brief web-based cognitive evaluation before and after training. if feasible, the investigators protocol will allow training older adults in critical cognitive skills for daily life situations. the web-based training is an advancement since it can be delivered at-home, remotely supervised, and is easily scalable. recently, remote interventions have been particularly relevant to older adults due to the covid-19 pandemic, which may limit in-person research participation.

Eligibility criteria:
inclusion criteria: * cognitively healthy older adults exclusion criteria: * low test scores (below 26 on the montreal cognitive assessment - moca) * presence of certain medical conditions (i.e., major neurological or psychiatric disorder, or a medical condition that may impact cognitive functioning). * subjects which english is not the primary language, or with lack of capacity to consent will not be enrolled.

Keywords: web-based cognitive training executive functions attention multi-tasking aging healthy adults
cycle pilot randomized trial

Conditions: Intensive Care Unit Acquired Weakness; Critical Care; Mechanical Ventilation; Respiratory Failure

Summary: background: patients in the intensive care unit (icu) are the sickest in hospital, and need advanced life-support. survivors of critical illness are very weak and disabled. up to 1 in 4 have severe leg weakness impairing their quality of life for as long as 5 years after icu discharge. in-bed cycling involves use of special equipment that attaches to a patient's hospital bed, allowing them gentle exercise while in the icu. methods: adult patients admitted to the icu who need a breathing machine and are expected to survive their icu stay are eligible. patients will randomly receive 30 minutes of in-bed cycling each day they are in the icu or routine physiotherapy, both delivered by specially trained physiotherapists. outcomes: feasibility: the investigators will study whether patients can cycle on most days of their icu stay, whether patients and their families agree to be a part of the study, and whether investigators can systematically assess patients' strength. relevance: effective methods of physiotherapy are needed for critically ill patients to minimize muscle weakness, speed recovery, and improve quality of life. this pilot randomized study is the second of several future larger studies about in-bed cycling in the icu. our pilot work includes cycle pilot and cycle vanguard. cycle pilot is an external pilot and enrolled 66 patients from 3/2015 to 6/2016. cycle vanguard is an internal pilot and enrolled 47 patients from 11/2016 to 3/2018. cycle vanguard patients will be analyzed in the main cycle rct (nct03471247).


Eligibility criteria:
inclusion criteria: * adults admitted to a medical-surgical icu within the 1st 4 days of mechanical ventilation (mv) and 1st 7 days of icu, and * could ambulate independently before hospital admission. exclusion criteria: * acute condition impairing patients' ability to cycle (e.g., leg fracture), * proven or suspected neuromuscular weakness affecting the legs (e.g., stroke or guillain-barré syndrome), * unable to follow commands in english pre-icu, * temporary pacemaker, * expected hospital mortality \>90%, * unable to fit the bike, palliative goals of care, or persistent therapy exemptions in the 1st 4 days of mv (e.g., cardiorespiratory instability, active major bleeding)
long-term neurovascular complications after radiation therapy in head and neck cancer

Conditions: Radiation Treatment; Neurovascular Complications

Summary: head and neck cancer is a group of cancers develop from the soft tissues, salivary gland, mucosa of the upper respiratory or digestive system covering the oral and nasal cavity. radiotherapy is usually the standard treatment of head and neck cancers. in the present study, investigators aim to study the prevalence of cervical-cranial vascular complications during the early stages in these head and neck cancer patients receiving radiotherapy. investigators will also compare the results between nasopharyngeal cancer and other head and neck cancerpatients receiving radiotherapy.


Eligibility criteria:
population: prospective cohort inclusion criteria: 1. age ≥20 years. 2. head and neck cancer patient . 3. had ever received radiation therapy (rt) ≦ 72 months before inclusion in the registry. 4. had ≥ 1 brain images and cervical-cranial vascular studies between the end of rt and d date of enrolment. exclusion criteria: 1. age \<20 years. 2. patients not willing to sign the informed consent. population: retrospective validation cohort inclusion criteria: 1. age ≥20 years. 2. head and neck cancer patient. 3. had ever received radiation therapy (rt) \> 120 months before the adoption date of irb at the participant site. 4. had ≥ 2 brain images and cervical-cranial vascular studies between the end of rt and 6\~10 years after rt, one within 5 years after rt, the other after 5 years after rt. exclusion criteria: 1.age \<20 years.