Kornimate/medical-research-clean huggingface dataset:
an extension study of imr-687 in adult patients with sickle cell anemia

Conditions: Sickle Cell Disease

Summary: this is an open-label extension study of imr-687 in adult patients who completed imara's blinded phase 2a study (imr-scd-102). the open-label extension study will evaluate long-term safety and tolerability.

this is an open-label extension study of imr-687 in adult patients with sca who were previously participants in the phase 2a study titled "a phase 2a, randomised, double-blind, placebo-controlled study of imr-687 in adult patients with sickle cell anaemia (homozygous hbss or sickle-β0 thalassemia)." this open-label extension study with imr-687 will evaluate the long-term safety and tolerability of imr 687 in adult sca patients. exploratory long-term pd parameters will also be examined.

Eligibility criteria:
inclusion criteria: 1. completed study imr-scd-102. 2. female subjects must not be pregnant, not be breast feeding, and be highly unlikely to become pregnant. male subjects must be unlikely to impregnate a partner. 3. subjects must be capable of giving informed consent and reading and signing the informed consent form after the nature of the study has been fully explained to them 4. subjects must be willing and able to complete all study assessments and procedures and to communicate effectively with the investigator and site staff. exclusion criteria: 1. subjects with hb \>12.5 g/dl or \<6 g/dl 2. subjects with known active hepatitis b or hepatitis c, with active or acute event of malaria or who are known to be positive for human immunodeficiency virus (hiv) 3. egfr \<50 ml/min 4. ast/alt \> 3x the upper limit of normal
effect of breathing exercises and upper limb endurance exercises in pregnant women presented with physiological dyspnea

Conditions: Pregnancy Related; Dyspnea

Summary: to evaluate the effects of breathing exercises and upper limb endurance exercises in pregnant women presented with physiological dyspnea

pregnant women undergo various anatomical and physiological changes so that they can cope with the increased physical and metabolic demands of their pregnancies. cardiovascular, respiratory, haematological, renal, gastrointestinal and endocrine systems undergo important physiological adaptations needed to allow development of the fetus and to allow the mother and fetus to survive the demands of childbirth . on the other hand, dyspnea can be caused by pregnancy complications, thus requiring specific medical treatment. shortness of breath is common during pregnancy, occurring in 60% to 70% of healthy pregnant women . the aim of the study is to evaluate the effects of breathing exercises and upper limb endurance exercises in pregnant women presented with physiological dyspnea

Eligibility criteria:
1. inclusion criteria: pregnant women presented with physiological dyspnea. 2. exclusion criteria: 1. non physiological causes of dyspnea in pregnancy * cardiac: arrhythmia, constrictive pericarditis , pericardial effusion , coronary heart disease , congestive heart failure , intracardiac shunt , cardiomyopathy , valvular heart disease. * chest wall, pleura, lungs: bronchial asthma, bronchiectasis ,bronchiolitis ,chronic obstructive pulmonary disease, pulmonary emphysema, interstitial lung disease, sarcoidosis ,lung tumor narrowing or compressing the airways , pleural effusion , pulmonary right-to-left shunt , pulmonary hypertension ,elevated hemi diaphragm, phrenic nerve palsy, kyphoscoliosis * cns and neuromuscular: amyotrophic lateral sclerosis , mitochondrial disease polymyositis/ dermatomyositis * metabolic: renal failure , thyroid disease * head and neck : laryngeal tumor ,vocal cord paralysis , vocal cord dysfunction , tumor compressing the upper airways , tracheal stenosis , goiter * others: anemia , anxiety disorder, panic attacks, , ascites , obesity, abdominal wall hernia 2. refusal to participate

Keywords: dyspnea breathing exercises pregnancy
cont. of a study to evaluate implanting peripheral nerve grafts into subjects with parkinson's disease (pd) during dbs

Conditions: Parkinson's Disease

Summary: this pilot study is designed to follow up on a previous, preliminary study and test the long-term safety and feasibility of the implantation of autologous peripheral nerve grafts into the substantia nigra, basal forebrain, putamen, and/or stn of participants with pd undergoing deep brain stimulation (dbs) surgery. peripheral nerve tissue contains schwann cells which produce growth factors that have been demonstrated to support the survival and function of neurons. participants will serve as their own donor for the tissue, which will be implanted at the time they undergo dbs surgery.

the primary objective of this pilot study is to demonstrate safety of the approach: introducing a minor modification of a standard, fda approved neurosurgical procedure in use for over a decade to implant autologous peripheral nerve into the central nervous system. as such, the study is designed to pose minimal risk and minimal inconvenience to the subjects. additionally, the test paradigm is performed strategically to not interfere with the surgery or delivery of the scheduled clinical dbs therapy. the scientific basis for this study is that the implanted peripheral nerve tissue is naturally well suited to provide multiple growth factors that have been shown experimentally to support the survival and function of dopaminergic neurons. central to this proposal is the hypothesis that the implanted tissue will physiologically deliver growth factors to restore to normal function the afflicted neurons found in pd. the first specific aim is to assess the feasibility and safety of the combined peripheral nerve graft/dbs surgical procedure. the second specific aim is to evaluate the long term clinical safety of the peripheral nerve implant. this pilot study will provide safety data that can be used to generate a larger phase iii clinical trial. if successful, it would herald the development of a new treatment for pd in which patients are able to provide their own tissue as a source of growth factors that could arrest or reverse the ongoing cellular loss that is responsible for their devastating dysfunction.

Eligibility criteria:
inclusion criteria: * undergoing dbs of the stn or gpi * between the ages of 40-75 * able to give informed consent * show a positive response to sinemet (carbidopa/levodopa) * be able to tolerate the surgical procedure exclusion criteria: * any condition that would not make the subject a candidate for dbs of the stn or gpi * under the age of 40 or over the age of 75 * unable to give informed consent * female who is pregnant, lactating, or of child-bearing potential unwilling to use an adequate birth control method during the period of the study

Keywords: deep brain stimulation schwann cells
evaluation comparing tau pet radiotracers, [18f]gtp1 and [18f]pi-2620 or [18f]mk-6240 in subjects with normal cognition or prodromal to moderate alzheimer's disease

Conditions: Alzheimer Disease (AD)

Summary: the study aims to compare tau targeted radiotracers \[18f\]gtp1 and \[18f\]pi-2620 or \[18f\]mk-6240 in subjects with normal cognition or prodromal to moderate alzheimer's disease (ad).


Eligibility criteria:
inclusion criteria * cognitively normal subjects aged 65 to 90 years and prodromal to mild ad subjects aged 50 to 90 years, inclusive at the time of screening. * prodromal to moderate ad subjects: meet the national institute on aging - alzheimer's association (nia-aa) core clinical criteria for mild cognitive impairment (mci) due to ad, probable ad dementia or ad dementia * have a clinical dementia rating (cdr) score of 0 (cognitively normal) or 0.5 (prodromal to moderate ad) at screening * have an mini-mental state examination (mmse) score 10-30 inclusive * have aβ pet imaging demonstrating aβ binding based on qualitative visual read at screening or using an acceptable historical pet scan (cognitively normal subjects will be assessed with aβ pet at screening but will not be required to demonstrate aβ binding). * a brain mri consistent with normal cognition or that supports a diagnosis of prodromal to moderate ad, with no evidence of other significant neurologic pathology. a previously acquired research mri within the last 12 months may be used if deemed acceptable by the investigator and no significant clinically relevant changes have occurred since the prior mri was obtained * the subject has an appropriate study partner capable of participating in cdr assessment and, if necessary, of accompanying the subject * for cognitively normal subjects only: history of at least one first degree relative with diagnosis of alzheimer's disease (self-reported by the potential subject and/or confirmed by the study partner). exclusion criteria * current or prior history of any alcohol or drug abuse within the last 2 years * prior participation in other research protocols or clinical care in the last year in addition to the radiation exposure expected from participation in this clinical study, such that radiation exposure exceeds the effective dose of 50 millisievert (msv), which would be above the acceptable annual limit established by the us federal guidelines * evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, alternative neurological, immunodeficiency, pulmonary, or other disorder or disease * mri evidence of cerebrovascular disease, infectious disease, space-occupying lesions, normal pressure hydrocephalus, or other central nervous system (cns) disease * implants that have not been certified for mri or history of claustrophobia in mri, unless an acceptable previously acquired research mri is available
urdu version of maastricht upper extremity questionnaire reliability validity study.

Conditions: Carpal Tunnel Syndrome

Summary: in this study, the examiners will investigate the reliability and validity of mastrict upper extremity scale in urdu language in pakistani patients with carpal tunnel syndrome.

the objective of this study is to translate as well as culturally adapt the mastrict upper extrimity scale (mueq) into urdu language and to test its reliability and validity in patients with carpal tunnel syndrome. this cross-sectional survey will use convenience sampling technique to enroll the participants on a pre-defined criteria. the outcomes of this study will help in finding the reliability and validity of mueq in patients with cts. the reliability of this scale will be examined using internal consistency and test-retest methods. the internal consistency will be checked by cronbach's alpha value. the test-retest reliability will be analyzed using an interclass correlation with patients.

Eligibility criteria:
inclusion criteria: * individuals who had to execute computer jobs in office. * individuals who have been working in present position for minimum 6 months * individuals who have been working for at least 4 hours or more in a day exclusion criteria: * individuals who had severe phsycytric and behavioral complaint * individuals who had prior injury of upper extremity * individuals who had any surgery of upper extremity
remote interactive intervention for loneliness

Conditions: Older Adults

Summary: background: during the covid-19 pandemic, governments around the world adopted the practice of physical distancing, which increased the loneliness experienced by seniors and indirectly affected their quality of life and social support. remote interaction through online social apps may be the safest and easiest way to address these problems. however, the empirical research on this issue is very limited. objective: this study investigated the impact of a 12-week remote interaction intervention on loneliness, quality of life, and social support for seniors living in a community during the covid-19 pandemic. methods: this study adopted a randomized controlled trial design and was conducted in communities in central taiwan. participants in the intervention group received a 12-week bidirectional remote interaction intervention, while participants in the control group received a 12-week unidirectional remote interaction intervention. the study's primary assessment tools were the ucla loneliness scale and the world health organization quality of life-bref scale (whoqol-bref). the secondary assessment tool was the inventory of socially supportive behavior.


Eligibility criteria:
inclusion criteria: * participants had to satisfy several inclusion requirements. they had to (1) be seniors aged 65 years or older; (2) be able to communicate in mandarin and taiwanese; (3) have an mmse score higher than 20 20 (following chiang et al., 2010); (4) be able to use a smartphone; and (5) have no previous psychiatric diagnosis. exclusion criteria: * the study excluded (1) those who were unable to understand how to use line or youtube; (2) participants in the experimental group who did not fully participate in the 12-week intervention (at least three days of interaction per week); (3) those who were unable to understand the content of the questionnaire or cooperate with those assigned to help them fill it in; and (4) those who had a major illness or surgery such as a fracture within the last three months.
efficacy and safety of eplivanserin treatment for sleep maintenance insomnia followed by optional extension up to 1 year

Conditions: Sleep Initiation and Maintenance Disorders; Insomnia

Summary: the purpose of the study is to assess efficacy and safety of eplivanserin in the population of patients complaining of sleep maintenance insomnia. the patients suffering from that condition frequently wake up during the night, their sleep is nonrestorative and they suffer from a significant distress or impairment in their daily activities consecutive to insomnia.

the study is being conducted worldwide. it consists of 4 segments: * segment a: 7-day run-in (screening) * segment b: 12-week double blind treatment * segment c: 40-week open treatment extension * segment d: 2-week run-out period

Eligibility criteria:
inclusion criteria: * out patients * each patient must have primary insomnia in accordance with dsm-iv-tr-axis i criteria * based on patient's information, the patient has spent at least 6.5 hours and not more than 9.0 hours, in bed, each night, over the preceding two weeks. * based on patient's information, the patient must complain of at least one hour of wakefulness after sleep onset for at least 3 nights per week over the preceding month * patient must report impact daytime functioning associated with sleep maintenance insomnia as measured by question 3 of insomnia severity index at screening visit and randomization visit. exclusion criteria: * females who are lactating or pregnant * woman of childbearing potential with a positive serum beta human chorionic gonadotropin pregnancy test at screening and not using an acceptable form of contraception * patients presenting with acute or chronic pain resulting in insomnia * patients with history of epilepsy or seizures * consumption of xanthine containing beverage (i.e. tea, coffee, or cola) comprising more than 5 glasses/day * evidence of any clinically significant, severe, or unstable acute or chronically progressive medical or surgical disorder which may affect patient safety * bmi \>32 * acute or chronic pain resulting in insomnia * patients with current psychiatric disorders according to dsm-iv-tr criteria, mental retardation, or dementia * clinically significant and abnormal ekg (qtc interval \>500 msec) * positive for hepatitis b or c * serious head injury or stroke within 1 year * use of otc medications such as valerian root, kava, melatonin, st. john's wort, or alluna; prescription sleep medications or anxiolytics within 1 week or 5 half-lives * participation in another trial within two month before the screening visit * use of any substance with psychotropic effects or properties known to affect sleep/wake * unable to complete the study questionnaires * night shift workers, and individuals who nap 3 or more times per week over the preceding month * history of: * primary hypersomnia * narcolepsy * breathing-related sleep disorder (such as sleep apnea) * circadian rhythm sleep disorder * parasomnia (somnambulism) * dyssomnia (such as periodic leg movements)

Keywords: primary insomnia sleeplessness early awakening chronic insomnia
breathing training and exercise capacity in non-cfb

Conditions: Non-cystic Fibrosis Bronchiectasis

Summary: the purpose of this research is to investigate whether a home-based and health coach supported specific breathing and respiratory muscle training program improves the ability to exercise, the function of the lungs and breathing muscles, and general clinical status in people with non-cystic fibrosis bronchiectasis (non-cfb).


Eligibility criteria:
inclusion criteria: * mayo clinic patient with confirmed diagnosis of non-cystic fibrosis bronchiectasis (non-cfb): non-cfb as confirmed by clinical history, including cough, shortness of breath, exertional dyspnea, pulmonary function tests, and high-resolution computed tomography. patients will be considered clinically stable if there is no evidence of an exacerbation or change(s) in medical therapy in the previous three weeks. * able and willing to provide informed consent to participate in the study. exclusion criteria: * presence of significant coexisting disease, neurological conditions, and/or orthopedic complications that affect ability to undertake exercise. * presence of advanced heart failure. * current use of antibiotics. * acute exacerbation(s) within 3-weeks prior to study commencement. * participation within a pulmonary rehabilitation program within 6-months prior to study commencement.
effect of nafamostat on postreperfusion syndrome (prs)

Conditions: Liver Transplantation; Postreperfusion Syndrome

Summary: this study intends to see the effect of nafamostat on the attenuation of postreperfusion syndrome (prs) that frequently occurs during liver transplantation.


Eligibility criteria:
inclusion criteria: * \>= 18 year old scheduled to undergo liver transplantation exclusion criteria: * previous history of pulmonary, cardiovascular, or renal disease * previous history of allergic reactions to nafamostat
assessment of human herpes virus reactivation 6 post autologous stem cells

Conditions: Hematologic Diseases

Summary: the purpose of this study is to assess the human herpes virus reactivation 6 post autologous stem cells in 196 patients. the aim of our study was to describe the incidence of reactivation of hhv-6 in patients requiring autologous hsct and determine the pathogenic role in this target population.


Eligibility criteria:
inclusion criteria: * all patients hospitalized in the hematology clinic of saint-etienne and clermont-ferrand and receiving autologous hematopoietic stem cells, according to the decision of the consultative meeting multidisciplinary service; * autologous recipients are included irrespective of causal hemopathy (myeloma, lymphoma, acute leukemia, mainly). exclusion criteria: * the non-consenting patients or unable to give consent
effects of neuromuscular electrical stimulation on muscle mass and strength in critically ill patients after cardiothoracic surgery

Conditions: Neuromuscular Electrical Stimulation; Intensive Care Unit Acquired Weakness; Muscle Wasting; Muscle Loss

Summary: the purposes of this study are 1) to determine whether neuromuscular electrical stimulation (nmes) is effective in preventing loss of muscle mass and strength and 2) to observe the time variation of mlt and strength from preoperative day to hospital discharge.

in the amendment of june 2011, a twofold study setting was defined in order to recruit patients not only before, but also after cardiothoracic surgery. in sample a, patients were recruited before surgery. in sample b, patients were recruited after surgery. on postoperative day 1, randomization was performed for sample a and b separately. to ensure balance of the nmes and control groups with respect to disease severity, randomization was stratified by the saps ii score on the first postoperative day. in the intervention group, the anterior muscles of both thighs were electrically stimulated from the first postoperative day until icu discharge for a maximum of 14 days. in the control group, the electrodes were applied, but no electricity was delivered.the primary outcomes muscle layer thickness (mlt) and muscle strength were assessed from the first postoperative day to icu discharge and at hospital discharge. all patients in sample a had an additional assessment of mlt and strength before surgery. all data are analyzed according to the intention-to-treat principle with no imputation for any missing data. linear mixed models are used to account for the repeated measurements per patient and to determine any fixed effects on mlt and mrc score.

Eligibility criteria:
inclusion criteria: * patients before/after cardiothoracic surgery * icu stay \> 48 hours exclusion criteria: * body mass index \> 40 kg/m2 * severe leg swelling * implanted ventricular assist device (rvad, lvad, bivad) * implanted intra-aortic balloon pump (iabp) * neuromuscular diseases * skin lesions in stimulation area * leg excluded if implant (hip or knee replacement) in stimulation area
video telehealth exercise training in cystic fibrosis

Conditions: Cystic Fibrosis

Summary: the purpose of this research study is to begin an exercise program for patients with a cystic fibrosis (cf) exacerbation.

the study will enroll 25 patients with cf during an introduction visit and initiate an ambulatory 1) tailored exercise regimen and 2) behavior change techniques focused on adherence and sustainability of exercise. the intervention will be delivered via a data-enabled smartphone with video capabilities facilitating live and interactive two-way video-conferencing using a hipaa compliant app. participants will receive supervised exercise paired with coaching on behavior change techniques over 12 weeks in 3 weekly 1-hour sessions, and will have monthly phone follow-ups and clinic follow-ups at 3 and 6 months.

Eligibility criteria:
inclusion criteria: diagnosed with cystic fibrosis 18 years old and older clinically stable with no exacerbation within 6 weeks exclusion criteria: any comorbidity that precludes exercise -