Kornimate/medical-research-clean huggingface dataset:
trial on the effect of optically modified fiber mattress covers on sleep disturbances in patients with chronic back pain

Conditions: Back Pain; Insomnia

Summary: sleep quantity and quality can be influenced by the type of mattress used. this study is being done to see if a mattress cover with optically active particles can help back pain and improve sleep quality.

it is commonly observed that sleep in its quantity and quality is influenced by the type of mattress used at night. a recent study in patients with back pain showed that waterbeds and foam mattresses did influence back symptoms, function and sleep more positively than did a hard mattress. pain improves with airbeds compared to regular innerspring mattresses. this study will analyze the effect of optically active particles mattress covers on sleep. the researcher is interested in learning if regular mattress or the study mattress cover (containing optically modified polyethylene terephthalate fiber mattress cover) is more useful in helping back pain and sleep quality.

Eligibility criteria:
inclusion criteria: you are eligible to participate in this study if you: 1. have a clinical diagnosis of chronic lower back pain 2. have pain measured on the visual analogue scale 3. have sleep disturbances at night associated with chronic lower back pain 4. are 18 years or older 5. sign the written, informed consent form prior to the initiation of any study procedures 6. have an habitual bedtime between 8 p.m. and 12 a.m. 7. are on a stable pain management regime exclusion criteria: you are not eligible to participate in this study if you: 1. are unwilling or unable to comply with the protocol or scheduled appointments 2. are unable to understand the language in which the approved informed consent is written 3. have no pain measured on the visual analogue scale 4. are unable to walk, wheel chair bound or confined to bed 5. are deemed by the investigator to be unreliable to wear the actigraphy, to complete the sleep log, to use the provided mattress covers at the proper time, to come to the scheduled visits or to answer questions regarding the subject's condition or medication use 6. lack a mobile arm to which to attach an actigraphy. 7. are currently participate or participated in another clinical study within the past 30 days 8. demonstrate an unwillingness to comply with the maximum limit of two alcoholic drinks per day and only 1 alcoholic drink after 6:00 p.m. for the duration of the protocol 9. use tobacco products or any other products during nightly awakenings that may interfere with the sleep wake cycle 10. have any unstable medical condition as determined by the investigator, or any other serious disease or condition that might affect life expectancy or make it difficult to successfully manage and follow the subject according to the protocol

Keywords: back pain sleep
tila-tace in treatment of hepatocellular carcinoma

Conditions: Tumor Response Rate; Overall Survival

Summary: to validate the tumor response rate: in the previous study, the investigators showed that tila-tace achieved 100% tumor response rate. however, as the study sample size was 40, the investigators need to validate the tumor response rate using a larger sample size; to validate the overall survival: in the previous study, the investigators showed that tila-tace significantly prolonged the overall survival of the patients with large and massive tumor. again, the sample size was small, the investigators need to validate the data using a large sample size.


Eligibility criteria:
inclusion criteria: * hepatocellular carcinoma is confirmed by tissue pathology or in accordance with clinical diagnosis standard; * ecog score 0-1; * hcc bclc grading 0, a, b, c; * child-pugh score prior to therapy a and b; * as judged by investigators, the patient can comply with the study protocol; * patient voluntarily participates in this study, understands the process of the study, and is willing to sign the written consent form. exclusion criteria: * hcc bclc grading d; * child-pugh score prior to therapy c.
ultrasound-guided alveolar recruitment in laparoscopic gynecological surgery

Conditions: Pulmonary Atelectasis

Summary: the study aims to compare the degree of atelectasis between ultrasound-guided alveolar recruitment group and conventional alveolar recruitment group in patients receiving laparoscopic gynecologic surgery


Eligibility criteria:
inclusion criteria: * adult patients scheduled to undergo elective laparoscopic gynecological surgery (laparoscopic ovarian cystectomy or laparoscopic salpingo-oophorectomy or laparoscopic hysterectomy or laparoscopic myomectomy) under general anesthesia, with asa physical status classification i or ii exclusion criteria: * previous history of lung surgery * patients having pneumonia, pneumothorax, or pleural effusion in preoperative chest x-ray * patients with copd, emphysema * patients with previous history of pneumothorax, or bullae * morbid cardiac disease * adolescent aged \< 18 years * anticipated duration of surgery \< 1 hour
natural history in ccfdn and ibm syndromes

Conditions: Inclusion Body Myositis, Sporadic; Inclusion Body Myopathy, Autosomal-recessive; Inclusion Body Myopathy, Autosomal-dominant; Congenital Cataracts, Facial Dysmorphism, And Neuropathy

Summary: so far, only limited data is available regarding the natural course in congenital cataract facial dysmorphism neuropathy syndrome (ccfdn) and sporadic and hereditary inclusion body myopathies (ibm). several criteria and outcome measures have led to contradicting results. the investigators want to retrospectively assess the natural course of the disease in ccfdn and ibm patients according to the data recorded during clinical routine visits.

we wanted to assess the natural course in congenital cataract facial dysmorphism neuropathy syndrome (ccfdn) and sporadic and hereditary inclusion body myopathies (ibm) over 10 years to gain new insights in both conditions.

Eligibility criteria:
inclusion criteria: * clinical and/or genetic diagnosis of congenital cataract facial dysmorphism neuropathy syndrome (ccfdn) and sporadic and hereditary inclusion body myopathies (ibm) exclusion criteria: * additional neuromuscular diseases
life satisfaction of fathers of children with cerebral palsy

Conditions: Cerebral Palsy; Father-Child Relations; Life Satisfaction

Summary: the purpose of this study is to examine the determinants of life satisfaction among fathers of children diagnosed with cerebral palsy.


Eligibility criteria:
inclusion criteria: * to be literate and to have no communication problems * to be the father of a child with cerebral palsiy (cp) and no other medical diagnosis (aged between 1-18 years) * to have a child with cp who regularly receives physiotherapy and rehabilitation * to live in the same house with his wife and child/children * to be willing to participate in the study exclusion criteria: * to care for individuals in need of care (such as disabled, elderly, chronically ill) additionally to the child with cp * to have a chronic disorder (such as neurological, rheumatologic, psychiatric disorder) that would affect life satisfaction.
implementation program to improve screening and management for ckd in diabetes (iris-ckd) (program 2)

Conditions: Chronic Kidney Disease(CKD); Type 2 DM; Type 2 Diabetes Mellitus (T2DM)

Summary: iris-ckd is a two-program implementation study to improve guideline-recommended screening and treatment of chronic kidney disease (ckd) in individuals with type 2 diabetes (t2d) in the united states.

iris-ckd management program: will compare prescriptions for guideline-directed medical therapies (gdmt) during the study period. to account for variable gdmt requirements, we will use opportunity scores to compare intervention arms. patients will be screened, identified and undergo consent by the study site. patients will receive educational materials related to ckd screening in t2d and details regarding the testing intervention study as per site specific recruitment requirements. the primary objective is to determine whether implementing a guided management program versus education alone will improve prescription of gdmt for people with ckd and t2d. patients will complete approximately 6 months of follow-up.

Eligibility criteria:
inclusion criteria: * (ckd management) * adults with type 2 diabetes (t2d) * receiving primary care within the healthcare system, visit within 24 months (any pcp provider, including app) * evidence of ckd based on laboratory testing within the past 2 years (must be confirmed during screening if not checked within 3 months of enrollment): * uacr \>300 mg/g or * egfr \<45 ml/min/1.73 m2 or * uacr ≥30 mg/g with egfr \<60 ml/min/1.73 m2 * receiving \<100% gdmt at baseline. for patients with uacr \<30 mg/g, gdmt includes sodium-glucose cotransporter-2 inhibitors (sglt2i) therapy. for all other eligible patients, gdmt includes acei/arb, sglt2i, and finerenone, unless contraindications for any of these therapies exist (e.g., hyperkalemia, diabetic ketoacidosis, etc.). exclusion criteria: * (ckd management) * type 1 diabetes * most recent egfr \<20 ml/min/1.73 m2 * prior kidney transplant * autosomal dominant polycystic kidney disease (adpkd) * active pregnancy or plans for conception within 1 year

Keywords: ckd t2dm t2d type 2 diabetes chronic kidney disease
effect of chlorhexidine cleansing on skin flora of newborns in nepal

Conditions: Bacterial Infection

Summary: the purpose of this study is to compare the reductions in skin flora of newborns after a single cleansing of the body with three concentrations of chlorhexidine (0.25%, 0.5%, 1.0%) and to examine the safety of skin cleansing in neonates in nepal.

studies in malawi, egypt, and nepal suggest that neonatal skin cleansing with chlorhexidine solutions may reduce the risk of infection and mortality. cleansing with 0.25% chlorhexidine in nepal resulted in a 28% reduction in mortality among low birth weight infants, while there was no impact on infants of normal weight. the mechanism of action for this observed benefit is not clear. chlorhexidine may remove pathogens from the skin of the newborn and/or prevent exposure to pathogens that may otherwise cause infection and lead to sepsis. the benefit of chlorhexidine cleansing may be extended with higher concentrations of chlorhexidine. infants born at the tribhuvan university teaching hospital in katmandu, nepal will be randomized to skin cleansing with chlorhexidine at one of three concentrations (0.25%, 0.50%, 1.00%). skin swabs will be collected before wiping, and two and twenty-four hours after wiping in order to compare levels of bacteria on the skin across the treatment groups. a small quantity of blood will be collected at 24 hours after wiping to determine the potential for absorption of chlorhexidine

Eligibility criteria:
inclusion criteria: * babies born at tribhuvan university teaching hospital * greater than 1500 grams exclusion criteria: * less than 1500 grams * requires major surgical procedure * clinically evident skin infection * generalized skin disease * major congenital anomoly

Keywords: chlorhexidine neonatal skin flora skin cleansing bacterial colonization
clinical trial in the treatment of allogeneic post-transplant cytopenias with sequential infusion of allogeneic mesenchymal cells expanded in vitro

Conditions: Cytopenia

Summary: the purpose of this study is to evaluate the safety and efficacy of the sequential infusion of allogeneic mesenchymal stem cells (msc), expanded "in vitro" with platelet lysate without addition of animal products in the treatment of patients undergoing allo-hsct who developed one or more cytopenias.


Eligibility criteria:
inclusion criteria: * patients with hematologic malignancies who have been subjected to allo-hsct and that are diagnosed with one or more peripheral cytopenias with complete chimerism in bone marrow (determined by molecular-str-studies). they may include: 1. patients who have received as a source of cells mo or sp 2. patients who have received cells from a related donor or unrelated hla-matched 3. patients transplanted with myeloablative or non-myeloablative conditioning * adequate cardiac function assessed from a clinical point of view by the researcher, with no history of ischemic heart disease (angina or myocardial infarction) in the previous 6 months. * adequate pulmonary function assessed clinically without evidence of severe obstructive or restrictive lung disease. * patients between 18 and 70 years * signed informed consent exclusion criteria: * patients whose haemopathy has not been controlled by the transplantation or is in progress at the time of treatment. * patients who do not have complete chimerism in bone marrow (performed within 28 days prior to baseline by molecular study -str-). * patients with thrombotic microangiopathy. * patients with post-transplant cytopenias with toxic origin in relation to antiviral treatment (eg ganciclovir, valganciclovir) without concomitant graft against host disease. * patients with bacterial, viral or fungal infection that is not being controlled with proper treatment. * patients with a history of ischemic heart disease (angina or myocardial infarction) in the previous 6 months, and those considered by the investigator does not have adequate cardiac function, evaluated from a clinical point of view. * patients with poor lung function, evaluated clinically, according to the researcher. * patients who, in the opinion of the investigator, are not on a good position to tolerate treatment. * patients who do not have the required donor. * women pregnant or at risk of pregnancy by contraceptive measures inadequate. * patients \ 70 years. * patients who did not sign the informed consent.

Keywords: cytopenia
fludeoxyglucose (fdg) positron emission tomography/computed tomography (pet/ct) cervical heterogenity imaging study

Conditions: Cervical Cancer

Summary: rationale: diagnostic procedures, such as positron emission tomography (pet) using fluorodeoxyglucose (fdg), may help determine response to standard cancer therapy in patients with cervical cancer the purpose of this study is to evaluate the change in cervical tumor heterogenity as measured by fdg-pet/ct imaging.


Eligibility criteria:
inclusion criteria: 1. biopsy-proven cervical cancer. (figo stage-ib2-iva) 2. age ≥ 18 3. able to receive chemoradiation therapy with cisplatin. 4. non-pregnant status in women of childbearing potential. 5. no other active cancer at the time of diagnosis of cervical cancer patients cannot have received treatment for any malignancy, with the exception of non-melanoma skin cancer, in the past 5 years. 6. patients with distant metastatic disease are eligible provided the estimated survival of the patient is at least 1 year. 7. scheduled to undergo or have already undergone fdg-pet/ct imaging for clinical staging of cervical cancer at barnes-jewish hospital clinical pet facility on a biograph 40 pet/ct scanner 8. able to give informed consent exclusion criteria: 1. age \< 18 2. patients with a known active malignancy other than cervical carcinoma. 3. pregnant and breastfeeding patients. 4. subjects whose tumors are not fdg avid on baseline standard of care fdg-pet/ct imaging

Keywords: cervical cancer positron emission tomography fluorodeoxyglucose
reproducibility of an immobilization device (bodyfix) - hodgkins/lymphoma

Conditions: Hodgkin's Disease; Lymphoma, Non-Hodgkin

Summary: radiation therapy has a well-established role in the treatment of hodgkin's disease and non-hodgkin's lymphoma. with technological developments, 3-d dimensional (3d) planning has evolved as a highly precise treatment planning option. high-precision radiation therapy has the potential for more accurate dose delivery to the tumour volume and can result in a greater sparing of normal tissue. an important component of safe radiotherapy delivery is the feasibility and reproducibility of current and new immobilization devices for highly conformal treatment. the purpose of this study is to determine the reproducibility of an immobilization device known as bodyfix(tm) using conventional treatment techniques.


Eligibility criteria:
inclusion criteria: * all patients undergoing curative or palliative treatment in whom it is considered that immobilization of part or all of an anatomical region would be of benefit to their care. exclusion criteria: * any case where ideal treatment may be compromised with use of immobilization method. * if the patient has any social issues, language barriers resulting in difficulties comprehending the nature of the study, or poor performance status, that could compromise compliance with the study guidelines.
prj2203: dolutegravir post authorization safety study (pass)

Conditions: Infection, Human Immunodeficiency Virus I

Summary: dolutegravir (dtg) is recommended for both treatment-naïve and treatment-experienced, hiv infected adults and paediatric subjects aged 12 years and older and weighing at least 40 kg. one case of suspected dtg hypersensitivity (hsr) reaction from among over 1500 subjects exposed to the drug at the time of submission in 4q2012, has been identified; this subject experienced a diffuse maculopapular rash with fever and elevated liver enzymes. isolated rash was uncommon in the dtg programme with less than 1% of clinical trial subjects experiencing treatment related rash. the pharmacovigilance strategy for dtg and dtg-containing products is to implement a post-marketing risk management program to further quantify the risk of hsr and compare it to that of other integrase inhibitors, and to possibly determine associated risk factors. in addition, the post-authorization safety study will monitor and compare hepatotoxicity and severe skin rash following initiation of dtg or other integrase inhibitor (raltegravir (ral) or elvitegravir (egv) based antiretroviral regimens (arv). further to be able to distinguish the above symptoms and reactions caused by dtg or the other integrase inhibitor regimen from that of abacavir (abc), known to cause hypersensitivity reaction, the integrase inhibitor groups will be compared in combinations with and without abc. this five year-long safety study will be conducted through collaboration with eurosida, a well established prospective observational cohort study of more than 18,200 subjects followed in 107 hospitals in 31 european countries, plus israel and argentina. this is a five year-long non-interventional prospective cohort study nested within the eurosida study. the study population will include hiv positive subjects over the age of 16 years from eurosida clinical sites, who are new users of dtg or other integrase inhibitors with and without abc. following initiation of dtg with abc based antiretroviral regimen or dtg without abc or regimens containing other integrase inhibitors (ral, egv) with or without abc or any other dtg based arv regimen as monotherapy or two-drug regimens, the study will aim to a) monitor and compare hypersensitivity reaction, b) monitor and compare hepatotoxicity, and c) monitor and compare severe skin rash among all subjects discontinuing dtg or other integrase inhibitor regimens for any reason.


Eligibility criteria:
inclusion criteria: * new users of dtg or users of other integrase inhibitor regimens (ral and egv) exclusion criteria: * none

Keywords: hypersensitivity reactions (hsr) hiv dolutegravir
a study to evaluate the safety and efficacy of paltusotine for the treatment of acromegaly

Conditions: Acromegaly

Summary: a randomized, placebo-controlled study designed to evaluate the safety and efficacy of paltusotine (also known as crn00808; an orally administered nonpeptide somatostatin agonist) in subjects with acromegaly previously treated with somatostatin receptor ligand (srl) based treatment regimens.


Eligibility criteria:
inclusion criteria: 1. male and female subjects ≥18 years of age 2. confirmed diagnosis of acromegaly and controlled (as measured by igf-1 ≤1.0×uln) via stable dose of protocol defined somatostatin receptor ligand therapy 3. females must be non-pregnant and non-lactating, and either surgically sterile, post-menopausal, or using effective method(s) of birth control 4. willing to provide signed informed consent exclusion criteria: 1. treatment naïve or treatment-withdrawn acromegaly subjects 2. prior treatment with paltusotine 3. pituitary surgery within 24 weeks prior to screening or history of pituitary radiation therapy 4. history or presence of malignancy except adequately treated basal cell and squamous cell carcinomas of the skin within the past 5 years 5. use of any investigational drug within the past 30 days or 5 half-lives, whichever is longer 6. known history of hiv, hepatitis b, or active hepatitis c 7. history of alcohol or substance abuse in the past 12 months 8. any condition that in the opinion of the investigator would jeopardize the subject's appropriate participation in this study 9. cardiovascular conditions or medications associated with prolonged qt or those which predispose subjects to heart rhythm abnormalities 10. subjects with symptomatic cholelithiasis 11. subjects with clinically significant abnormal findings during the screening period, or any other medical condition(s) or laboratory findings that, in the opinion of the investigator, might jeopardize the subject's safety or ability to complete the study 12. subjects currently taking pasireotide lar (within 24 weeks prior to screening) or pegvisomant, dopamine agonists (within 12 weeks prior to screening), or short acting somatostatin analogs (within 12 weeks prior to first dose of study drug)

Keywords: acromegaly pathfndr paltusotine crn00808
effects on ck, rpe, vas scale and physical performance of three recovery methods in elite basketball players

Conditions: Cold-water Immersion; Protein-carbohydrates Supplementation; Active Recovery; Placebo

Summary: the aim of this study was to compare the effects of cold water intermittent ion (cwi), carbohydrate and protein supplementation (suppl), and active recovery (act) on creatine kinase (ck), perceptual and performance markers of recovery in elite basketball players after a specific fatigue protocol. fifteen elite basketball players participated in this crossover controlled trial. all participants were randomly measured in 4 conditions of the recovery method 1 week apart after a fatigue exercise protocol (\~ 45 'of high intensity intermittent effort with specific basketball movements). the recovery methods consist of cwi at 10oc in periods of 2 minutes submerged and 2 minutes out of the water, supplementation with 0.3gr / kg of maltodextrin and 0.2gr / kg of neutral whey protein in 0.5 liters of water, pedaling act for 25 minutes at 50% of maximum heart rate or a placebo drink (pla). the visual analogue fatigue scale (vas), perceived exercise rate (rpe), ck and physical performance (jumping, speed, isometric and dynamic tests of resistance to squats) were measured before, after and 24 hours after of the protocol. the vas scale and rpe were also measured immediately after application of the recovery method. repeated 2-way post-hoc comparisons of anova and bonferroni measures were applied, with a significance set at p \<0.05.


Eligibility criteria:
inclusion criteria: * having at least 10 years of sports practice, * having been training during the season a minimum of four times a week, * not having suffered serious or minor but recently injuries, * having competed and trained regularly in the previous season. exclusion criteria: * suffering an injury during the study period * not having gone through all the treatment groups (cwi, carbohydrate-protein supplementation, active recovery and placebo)

Keywords: cryotherapy recovery strategies nutrition team sports invisible training exercise-induced muscle damage