Kornimate/medical-research-clean huggingface dataset:
phase 2 trial of prophylactic rituximab therapy for prevention of cgvhd

Conditions: Leukemia, Mast-Cell; Mantle-cell Lymphoma

Summary: to determine if rituximab administered after allogeneic transplantation decreases the incidence of chronic graft-vs-host disease (cgvhd)

to test if prophylactic anti-b-cell therapy (weekly rituximab) given within 60 to 90 days after allogeneic transplantation will decrease allogeneic donor b-cell immunity and possibly the incidence of chronic graft-vs-host disease (cgvhd).

Eligibility criteria:
recipient inclusion criteria: * between 18 and 76 years of age * chronic lymphocytic leukemia (cll): * unmutated igg vh gene status * mutated igg vh genes (\> 2% nucleotide change compared to somatic sequence) * complete remission benefit most from allogeneic hematopoietic stem cell transplant (hsct). (physicians will be encouraged to provide aggressive chemotherapy prior to nonmyeloablative transplantation.) * mantle cell lymphoma (mcl): transplant physicians believe subject would benefit from allogeneic hsct. * adequate renal (cr \< 2.4 mg/dl) and hepatic (bilirubin \< 3.0 mg/dl, aspartate aminotransferase (ast) \< 100 iu) function. * men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for six months after completion of treatment. * all subjects must provide written informed consent donor inclusion criteria: * genotypically or phenotypically human leukocyte antigen (hla)-identical. * age \< 76 unless cleared by institutional pi * capable of giving written, informed consent. * must consent to peripheral blood stem cell (pbsc) mobilization with g-csf and apheresis recipient exclusion criteria: * recipient has a 9 of 10 or 10 of 10 hla identical donor (high resolution molecular genotyping at hla a, b, c and drb1, and dq) * pregnancy * lactating * serious uncontrolled infection * hiv seropositivity * hepatitis b or c seropositivity * cardiac function: ejection fraction \< 40% or uncontrolled cardiac failure * pulmonary: diffusing capacity - carbon monoxide (dlco) \< 50% predicted * liver function abnormalities: elevation of bilirubin to ≥ 3 mg/dl and/or ast \> 100 * renal: creatinine \> 2.4 * karnofsky performance score ≤ 60% * patients with poorly controlled hypertension (systolic blood pressure \> 150 or diastolic blood pressure \> 90 repeatedly). * known life-threatening hypersensitivity to rituximab or other anti-b cell antibodies. * inability to comply with the allogeneic transplant treatment. * uncontrolled central nervous system (cns) involvement with disease donor exclusion criteria: * identical twin to subject * contra-indication to subcutaneous g-csf at a dose of 16 mg/kg/d for 5 consecutive days * serious medical or psychological illness * prior malignancy within the preceding five years, with the exception of non-melanoma skin cancers. * hiv seropositivity
prevention of white spot lesions using bioactive gel

Conditions: White Spot Lesions

Summary: white spot lesions are a common problem and are reported in up to 96% of orthodontic patients. in this study, the preventive effect of bioactive gel is evaluated in comparison to fluoride.

dental caries is a chronic infectious disease present worldwide and is among one of the most common oral diseases. it is a multifactorial disease resulting from imbalance between demineralization and remineralization initiated by acid producing bacteria in the microenvironment. the incipient form of caries, white spot lesions (wsl), is characterized by primitive enamel surface and subsurface demineralization and could be identified clinically by their chalky white appearance . orthodontic treatment is a major risk factor for the development of wsl. they are reported in up to 96% of orthodontic patients. many materials are being used to prevent white spot lesions with fluoride being the most commonly used . new materials have been emerged such as giomer based bioactive gel with the ability to release six ions fluoride inhibits demineralization and promotes deposition of fluoroapatite. aluminum helps to decrease demineralization as well by forming alumino fluoro complexes. borate reduces biofilm formation beside its antibacterial effect. silica promotes remineralization by inducing apatite nucleation on the tooth surface. strontium converts hydroxyapatite into strontium apatite thus increasing acid resistance and has an inhibitory effect on bacterial growth. other ions such as na act as strong base and have acid buffer capacity.

Eligibility criteria:
inclusion criteria: * patients assigned for orthodontic treatment with fixed appliances * sound teeth with fixed orthodontic appliances * either maxillary or mandibular teeth or both exclusion criteria: * patients with poor oral hygiene * allergic reaction to the materials used. * lack of compliance. * xerostomia * evidence of parafunctional habits. * active carious lesions * dental fluorosis * hypocalcified teeth * systemic diseases affecting teeth such as amelogenesis imperfecta * severe periodontal affection

Keywords: white spot lesions orthodontic treatment prevention bioactive gel
functional outcome in operative and nonoperative management in isolated greater tuberosity fracture of humerus bone

Conditions: Greater Tuberosity Fracture

Summary: constant score for functional outcome in operative and non-operative management in isolated greater tuberosity fractures of humerus bone.

fractures of the greater tuberosity (gt) often occur with more complex proximal humerus fractures and are less frequently observed as an isolated pathology. only 14-20% of proximal humerus fractures are isolated lesions of the gt. up to 30% of these fractures are associated with anterior glenohumeral dislocations. according to neer, a displacement of the fragment \>5mm and 30°, or \>3 mm of displacement in active patients involved in frequent overhead activity is believed to be an indication for operative treatment. however, indication for all other fractures had managed by nonoperative treatment is unclear. currently, there is a lack of evidence in the literature to support either conservative or operative treatment strategies in gt humerus fractures. the fracture type and the etiology of the fracture impact the decision- making and the final outcome also remains unclear. age of more than 65 years as an important risk factor for secondary displacement in the conservative management of fractures of the greater tuberosity. furthermore, fracture type and shoulder joint dislocations were factors associated with show increased relative risks for secondary fragment displacement.

Eligibility criteria:
inclusion criteria: * 1-history of traumatic isolated gt fracture. exclusion criteria: - 1- associated proximal humeral fracture. 2 - previous shoulder pathology.
a study to evaluate the impact of lactobacillus rhamnosus gg on proton pump inhibitor-induced gut dysbiosis

Conditions: Healthy

Summary: the purpose of this study is to investigate the impact of the probiotic lactobacillus rhamnosus (lgg) on proton pump inhibitor (ppi)-induced changes to the microbes that live in the gastrointestinal tract and are passed out in the stool. ppi medicines reduce stomach acid and are commonly used to treat acid reflux disease.


Eligibility criteria:
inclusion criteria: * individuals on an unrestricted regular diet with no dietary restrictions (vegan, low fodmap, gluten free, dairy-free etc) or other fad diets (e.g., keto, intermittent fasting, etc.). * healthy subjects will be screened for current or chronic gi symptoms using a 16-item questionnaire. * only those with an absence of symptoms will eligible to participate. exclusion criteria: * for healthy volunteers, will include prior surgery altering the esophagus, stomach, and intestine (except appendectomy). * chronic daily use of medications affecting gi secretion or motor function. * the presence of any gi-motility affecting systemic diseases or untreated psychiatric disease. * pregnancy.
microdevice for evaluating drug response in site in lung lesions

Conditions: Lung Tumor; Lung Cancer

Summary: this is a pilot study for placement of a tiny microdevice into lung tumors to more precisely predict tumor-specific drug sensitivity, and to help inform systemic therapeutic decisions. the microdevice will provide a novel technique for interrogating human lung tumor tissue in situ, and will uniquely facilitate assessment of response to multiple drugs simultaneously. this will not only increase the specificity of a particular participant's chosen systemic therapy, it will also augment the speed and efficiency with which investigators are able to make clinical decisions regarding choice of therapy.

the initial aims in this pilot study will focus on the safety and feasibility of microdevice placement and retrieval in participants with suspicious lung lesions. the microdevice, which is 5.5 mm in length and approximately 750 µm in diameter (i.e., comparable in size and shape to commonly used fiducial markers), will be placed in the suspected tumor tissue at the time of surgical resection. multiple agents will passively diffuse into local, confined regions (several microns) of the surrounding microenvironment. the agents are released at approximately one millionth of a systemic dose. the device(s) will be removed for analysis at the time of resection, which will be performed for clinical indications independent of enrollment in this study. the investigators will collect data regarding the safety and feasibility of the placement and retrieval of the microdevices, and perform detailed tissue analysis of drug response. investigators hope to compile preliminary data regarding correlations between in situ drug response and the genetic and histopathologic features of tumors, systemic treatment response, and ultimately, clinical outcomes.

Eligibility criteria:
inclusion criteria: * patients with a suspicious lung lesion for which surgery is indicated for either diagnostic or therapeutic purposes, as determined by the treating thoracic surgeon * masses with a minimum longest dimension of 1 cm * 18 years of age or older * documented, signed, dated informed consent for both the surgical resection as well as the proposed research study obtained prior to any procedures exclusion criteria: * subjects who do not wish to undergo surgical resection, or those who are high-risk or not candidates for surgical resection in the opinion of the treating surgeon * women of childbearing potential without a negative pregnancy test; or women who are lactating

Keywords: microdevice chemotherapy lung lesions
the temporo-spatial dynamics of genital tract microbiota

Conditions: Infertility, Female

Summary: the investigators aim to examine the endometrium with state of the art sequencing techniques to investigate the endometrial microbiota. the endometrial microbiota has been perceived to be sterile, however, this seems incorrect from recent studies. thus, the primary outcome is to compare the rate of ascending infection from the semen to the vagina to the endometrium and to investigate which bacteria are capable of inhabiting these environments. furthermore, cervical mucus will be obtained in order to test for immunological, microbiological and mechanical properties that may be involved in ascending infection. finally, the study aim to characterize the temporal changes in the vaginal microbiota during estrogenic treatment with estrofem® or vivelle dot (r) for preparation of the endometrium prior to embryo transfer.


Eligibility criteria:
inclusion criteria: * patients in ivf freeze-all/segmentation treatment protocol. * written informed consent. exclusion criteria: * uterine malformations * hiv, hepatitis b or c positivity. hpv cin 2 or higher. chlamydia trachomatis positivity. * any uncontrolled concomitant disease (e.g. uncontrolled diabetes, uncontrolled hypertension etc.)
comparing two techniques of haemostasis after cervical conization

Conditions: Cervical Intraepithelial Neoplasia; Cervix Neoplasm

Summary: the leep conization is commonly used for cervical pathologies treatment. the techniques for hemostasis usually used are: cautery, monsel's solution and vaginal pack. actually, there is no consensus about the best technique and there is not much information that validates the use of some of that. to compare the use or not of vaginal pack as methods of hemostasis after leep conization for management of cervical lesions.

a randomized clinical trial was conducted at gynecology oncology department/barretos cancer hospital for patients with indication of leep conization. after local irb approval, patients were allocated in two arms (50 patients each): without vaginal pack (group 1 - gp1) and with vaginal pack (group 2 - gp2). the monsel's solution was used in all patients. intraoperative and postoperative outcomes will be evaluated: operative time, intraoperative and postoperative bleeding, hormonal status, age, parity and cone specimens' characteristics as well as short-term outcome were recorded and compared using chi-square test, fisher exact test and t-test where appropriate.

Eligibility criteria:
inclusion criteria: * indication of cervical conization. exclusion criteria: * we excluded patients who were not treated by our department physicians or if the patient did not return for follow-up.

Keywords: cervical intraepithelial neoplasia haemostasis vaginal pack loop electrical excision procedure randomized clinical trials uterine cervical neoplasm
simcoach evaluation: a virtual human intervention to encourage servicemember help-seeking for ptsd and depression

Conditions: Post-traumatic Stress Disorder; Depression

Summary: simcoach, a computer program featuring a virtual human that speaks and gestures in a videogame-like interface, is designed to encourage servicemembers, especially those with signs or symptoms of post-traumatic stress disorder (ptsd) or depression, to seek help to improve their psychological health. the assessment included a formative component assessing simcoach's design, development, and implementation approaches, as well as a summative component assessing outcomes among participants in a user experience survey and a randomized controlled trial (rct).


Eligibility criteria:
inclusion criteria: * 18 years of age and * active duty or reserve servicemember or national guard servicemember and * being off duty exclusion criteria: * under the age of 18 years * retired servicemember or not a servicemember * currently on duty * currently incarcerated, on parole, or on probation
stress reduction study for partners of early stage dementia

Conditions: Dementia Caregiving

Summary: this is a study designed to pilot a woop (wish outcome obstacle plan) intervention for spouses of persons with early stage dementia for the purposes of future research. the investigators will be using two cohorts. one who will get the intervention and the other who will be wait listed and receive the intervention at a later date. spouses of persons with dementia will use woop, a brief goal attainment sequence, every day for 16 days. participants will complete surveys before the intervention, at day 16, and at a 3-month follow-up. the outcome measures are goal attainment, emotion regulation skills, psychological health, and support quality. as of 9/2020 this entire study is being conducted remotely.


Eligibility criteria:
inclusion/exclusion criteria: * the couple is married or in a cohabiting, committed relationship. * one partner has early adult dementia (ad) or a related dementia using criteria: symptoms consistent with early-stage dementia or memory impairment (e.g., ad, vascular dementia) and scores on the neuropsychiatric inventory (npi) ≥3; mini-mental state examination (mmse) ≥18 and ≤27; and barthel index (bi) ≥5 and ≤1923. or\>20 on telephone interview for cognitive status. (tics) * the spouse will have to score 27 or higher on the mmse. or\>25 on tics. * both participants must agree to participate and complete baseline interviews. * both partners are at least 60 years old.
analgesia comparison of nalbuphine and morphine for laparoscopic myomectomy

Conditions: Postoperative Pain

Summary: to compare the analgesia and side effect of nalbuphine and morphine for elective laparoscopic myomectomy.

to compare the analgesia and side effect of nalbuphine and morphine for elective laparoscopic myomectomy, by using patient controlled analgesia postoperatively, a randomized, double blind clinical trial. patients undergoing elective laparoscopic myomectomy are randomly divided into two groups: nalbuphine and morphine groups. all patients are under general anesthesia with routine methods. the nalbuphine group receive postoperative patient controlled analgesia using nalbuphine 30mg/120ml, while the morphine group receive postoperative patient controlled analgesia using morphine 60mg/120ml. perioperative parameters are to be collected to compare the two groups.

Eligibility criteria:
inclusion criteria: * elective laparoscopic myomectomy patients 24hr post-operative patient controlled analgesia analgesia no mild or severe liver or renal disfunction exclusion criteria: * can't understand patient controlled analgesia device refuse trial
a study of t-20 in hiv-positive adults

Conditions: HIV Infections

Summary: the purpose of this study is to see if it is safe and effective to give t-20 to hiv-positive adults. t-20 is an anti-hiv drug.

patients are randomly placed into 1 of 6 groups: 4 dose levels of t-20 are given by subcutaneous infusion and 2 by subcutaneous injection. the entire study lasts 7 weeks; including a 2-week screening period, followed by 28 days of treatment and 1 week of follow-up.

Eligibility criteria:
inclusion criteria concurrent medication: allowed: * any antiretroviral agent, provided the regimen has not changed within 6 weeks of the screening visit. * antibiotics for bacterial infections. * prophylactic medications for p. carinii pneumonia and for m. avium, including azithromycin. * medications for symptomatic treatment such as antipyretics, analgesics, and antiemetics. patients must have: hiv-1 seropositive status. exclusion criteria co-existing condition: patients with the following symptoms or conditions are excluded: concurrent neoplasm (except for basal cell carcinoma of the skin, in situ carcinoma of the cervix, and non-disseminated stable kaposi's sarcoma). concurrent medication: excluded: * patients must not be taking any concurrent antiretroviral therapy (for at least 2 weeks prior to baseline) or the patient is to be on a stable antiretroviral regimen which has not changed for at least 6 weeks prior to baseline. * treatment with any of the following: * immunomodulators, biological response modifiers, chemotherapy that cannot be discontinued for the duration of the study, astemizole, terfenadine, cisapride, triazolam, midazolam, rifampin, clarithromycin, or an investigational drug within 30 days prior to the initial visit. patients with the following prior conditions are excluded: * evidence of active opportunistic infections, or unexplained temperature greater than or equal to 38.5 celsius for 7 consecutive days within 30 days prior to screening visit. * chronic diarrhea (defined as greater than 3 liquid stools per day which persists for 15 days) within 30 days prior to screening visit. * diagnosis of hemophilia or other clotting disorders. prior medication: excluded: - prior treatment with an hiv vaccine. prior treatment: excluded: major organ allograft. risk behavior: excluded: evidence of substance abuse or addiction that, in the opinion of the investigator, may interfere with the patient's ability to comply with the dosing schedule and protocol evaluations.

Keywords: injections, subcutaneous hiv-1 anti-hiv agents peptide t20
subjective memory complaints, objective memory performance and cognitive training

Conditions: Fatigue Syndrome, Chronic; Chronic Pain; Anxiety Disorders; Depressive Disorder; Sleep Disorders

Summary: the aim of this study is to examine if repetitive computerized cognitive training improves working memory in patients who are on sick leave due to complex symptom disorders (chronic pain, chronic fatigue, anxiety, depression and or sleep disorders), and whether effects of cognitive control training transfer to other tasks.


Eligibility criteria:
inclusion criteria: * on sick leave due to complex symptom disorders: chronic pain, chronic fatigue, anxiety, depression and/or sleep disorders * on sick leave for at least eight weeks. exclusion criteria: * severe mental disorder * acute psychosis * ongoing manic episode * suicidal ideation * ongoing abuse of alcohol or any other substance. * not able to communicate in norwegian

Keywords: cognitive therapy
a study of ly3209590 in japanese participants with type 2 diabetes mellitus

Conditions: Diabetes Mellitus, Type 2

Summary: the main purpose of this study is to evaluate the safety of a study drug known as ly3209590 in japanese participants with type 2 diabetes. side effects and tolerability will be documented. blood samples will be taken to compare how the body handles the drug and how it affects blood sugar levels. the study will last almost five months for each participant.


Eligibility criteria:
inclusion criteria: * have type 2 diabetes mellitus (t2dm) for at least 1 year * have received a stable daily dose of basal insulin at screening * have hemoglobin a1c (hba1c) greater than or equal to (≥)6.5 percent (%) and less than or equal to (≤)10.0% at screening * have a body mass index greater than (\>)18.5 and ≤40.0 kilograms per square meter (kg/m²) at screening exclusion criteria: * have received a total daily dose of insulin \>1.2 units per kilogram (u/kg) of body weight at screening * have received insulins except for basal insulins * have received sulfonylurea at more than half of the maximum approved dose level * have a history of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reaction or history of significant atopy * have had more than 1 episode of severe hypoglycemia within 6 months before entry
twenty-five-year experience with the medtronic-hall valve prosthesis

Conditions: Aortic Valve Disease

Summary: background-:. the medtronic-hall (mh) valve was developed and for the first time implanted in oslo in 1977. a total of 1,104 patients received this valve at rikshospitalet-radiumhospitalet hf in the period 1977-87. in the present study we followed all 816 patients undergoing aortic valve replacement (avr) over a 25-year period.

the medtronic-hall (mh) tilting valve disk was first implanted in oslo in june 1977. from 1977 through 1987, the valve was used as the only valve of choice and inserted in a total of 1,104 consecutive patients at our department. the mh valve is made of a single piece of titanium with no welds. the disk is made of tungsten impregnated graphite with a carbon pyrolytic coating. the tungsten renders the disk radiopaque. in the aortic position the maximal opening is 75˚. a central aperture in the disk allows free rotation. the valve is rotatable in the sewing ring. the sewing ring is made of teflon. aortic sizes are 20-31 mm (outer diameter). the initial clinical results were published in 1979 (1). the cohort of patients has been followed-up and analysed at 5, 10 and 15 years (2-5). in the present study we report our 25-year follow-up data for the 816 patients undergoing aortic valve replacement (avr) with special reference to survival, functional status, valve-related complications and the impact of concomitant surgery.

Eligibility criteria:
inclusion criteria: * all patients with aortic valve replacement 1977-87

Keywords: valves, heart disease, prosthesis.