Kornimate/medical-research-clean huggingface dataset:
dendritic cells in patients following allogeneic hematopoietic stem cell transplantation

Conditions: Graft Versus Host Disease

Summary: we plan to investigate prospectively and simultaneously skin and blood dc subtypes, their donor/recipient origin and the correlation of dc reconstitution kinetics with treatment, clinical outcome and incidence of agvhd in patients undergoing allogeneic hematopoietic stem cell transplantation.

blood and skin dc reconstitution shall be investigated in patients affected by hematological diseases and receiving hla-matched, mobilized peripheral blood stem cells from related or unrelated donors. we plan to simultaneously collect and process double biopsies, i.e. from graft versus host disease affected and non-lesional skin of patients at onset of acute graft versus host disease following allogeneic hematopoietic stem cell transplantation. emigration assay, chimerism analysis and immunohistochemistry will be performed.

Eligibility criteria:
inclusion criteria: * patient undergoing an allogeneic hematopoietic stem cell transplantation * older than 18 years * who-performance-status 0 to3 * informed consent * graft versus host disease of the skin exclusion criteria: * clotting parameters more than double of normal * infection of the skin * leucocytes \< 1000/µl; thrombocytes \< 20 000/µl

Keywords: graft versus host disease allogeneic hematpoietic stem cell transplantation
pain and discomfort during maxillary expansion

Conditions: Crossbite; Maxillary Hypoplasia

Summary: the aim of the present study is to investigate and analyze the perception of pain and function impairment during the first week of activation with two different palatal expansion screw to identify an effective pain prevention protocol.

maxillary expansion with fixed appliance is a well-known and consolidated practice in clinical orthodontics but current findings of "evidence based dentistry" have not yet identified a better clinical expansion protocol. this issue is due both to the several expansion screws available on the market and to the different screw activation protocols, which could be grouped into rapid and slow, with several customizations. a recent systematic review has shown that both rapid and slow expansion protocols are clinically effective on the primary outcome, i.e. the resolution of the crossbite with a significant increase of skeletal transversal dimension in the maxillary transverse deficiency subjects. if the type of appliance based on its ability to solve the maxillary constriction is not any more the main selection criteria, the choice of the orthodontist should, therefore, be based on the timing and on a "patient-oriented" device, that minimizes the side effects, such as e.g. appliance breakages, functional impairments and pain. in the orthodontic daily practice, the pain of the little patient is the most frequent symptom during treatment and is the one that most frightens/worries the child and the family. literature shows that rapid maxillary expansion is, among the early orthodontic therapies, the one with the highest frequency of pain (up to 98%) as an adverse symptom reported by patients. the pain is statistically linked to the rapid expansion protocol (2/turn/day), during which, for each activation of the screw (0.2 or 0.25 mm) the force expressed can reach up to 10 pounds which acts in an orthopaedic manner on the palatine suture and the circummascellar sutures. following this orthopedic action, a disorganized and highly vascularized connective tissue (inflammatory) is formed in palatine suture area, which becomes the main receptor of the pain perceived by the patient during the active maxillary expansion. in the literature the prevention and management of pain during palate expansion is a poorly analyzed topic, despite being a daily problem in orthodontic clinical practice and so the aim of the present study is to investigate and analyze the perception of pain and function impairment during the first week of activation with two different palatal expansion screw to identify an effective pain prevention protocol.

Eligibility criteria:
inclusion criteria: * subjects with transversal maxillary deficiency (with or without crossbite). * class i or class ii dental malocclusion with uni- or bilateral crossbite and/or constricted maxilla * before the pubertal peak (cvm 1-3). exclusion criteria: * patients with previous orthodontic treatment * hypodontia in any quadrant excluding third molars * inadequate oral hygiene * craniofacial syndromes, or cleft lip or palate
optic nerve sheath diameter: a non-invasive indicator of intracranial pressure in the intensive care unit monitoring

Conditions: ICP (Intracranial Pressure) Increase; Optic Nerve Sheath Diameter; Intracranial Hypertension

Summary: determination of high intracranial pressure (icp) is necessary for the treatment of patients with raised icp to improve long-term neurological outcomes. ultrasonographic optic nerve sheath diameter (onsd) measurement is a noninvasive, easily performed and cost effective technique for detecting high icp.

icp measurements via ventricular catheters provide csf drainage and icp reduction. the normal icp value is less than 15 mmhg in adults. in the literature the correlation of onsd and invasive icp measurements were determined. the aim of study is to evaluate the correlation of onsd and direct icp measurements and to determine cut off onsd value to detect icp ≥15 mmhg.

Eligibility criteria:
inclusion criteria: * 18-80 aged patients * with an external ventricular drainage catheter due to intracranial pathology exclusion criteria: * under the age of 18 * orbital tumors * graves' disease * exophthalmos * sarcoidosis * optic neuropathy * meningitis * ocular trauma * lung diseases

Keywords: onsd ultrasonography noninvasive increased intracranial pressure
safety and efficacy of idec-114 in the treatment of non-hodgkin's lymphoma

Conditions: Non-Hodgkin's Lymphoma

Summary: the purpose of this study is to determine whether anti-cd80 monoclonal antibody (idec-114) is effective in the treatment of follicular b-cell non-hodgkin's lymphoma. this drug has never been studied in patients with lymphoma, however, it has been studied in psoriasis patients at various dose levels and schedules.


Eligibility criteria:
inclusion criteria: * histologically confirmed follicular lymphoma that has relapsed or has failed primary therapy * progressive disease requiring further treatment * bidimensionally measurable disease * acceptable hematologic status * prestudy who performance status of 0, 1, or 2 * expected survival of \>/= 3 months * patients with reproductive potential must follow accepted birth control methods during treatment and for 3 months after completion of treatment * female patients must not be pregnant or lactating * recovered fully from any significant toxicity associated with prior surgery, radiation treatments, chemotherapy, biological therapy, abmt, or investigational drugs exclusion criteria: * cancer radiotherapy, biological therapy, or chemotherapy within 3 weeks of first scheduled treatment (6 weeks if nitrosourea or mitomycin-c) * prednisone or other immunosuppressive therapy within 3 weeks of first scheduled treatment * prior antibody therapy for lymphoma (including radioimmunotherapy) within 6 months prior to first scheduled treatment * previous exposure to idec-114 or any anti-cd80 antibody * abmt within 6 months prior to first scheduled treatment * abnormal liver function * abnormal renal function * presence of chronic lymphocytic leukemia (cll) * presence of cns lymphoma * presence of hiv infection or aids * prior diagnosis of aggressive non-hodgkin's lymphoma or mantle-cell lymphoma * another primary malignancy (other than squamous cell and basal cell carcinoma of the skin, in situ carcinoma of the cervix, or treated prostate cancer with a stable psa) for which the patient has not been disease-free for at least 3 years * serious nonmalignant disease which would compromise protocol objectives in the opinion of the investigator and/or the sponsor * new york heart association class iii or iv cardiac disease or myocardial infarction within 6 months prior to first scheduled treatment * major surgery, other than diagnostic surgery, within 4 weeks prior to first scheduled treatment * pleural invasion and/or effusion with positive cytology for lymphoma * peritoneal invasion and/or ascites with positive cytology for lymphoma
adventhealth research institute non-alcoholic fatty liver disease biobank and registry (avail)

Conditions: Non-Alcoholic Fatty Liver Disease

Summary: the purpose of this study is to create a resource that will advance research that is focused on discovery of novel therapies, risk stratification, and aggressive interventions for those at highest risk for non-alcoholic fatty liver disease (nafld). to achieve this, we will generate a biobank of liver tissue collected during standard of care liver biopsies. paired blood/urine samples, fibroscan and relevant data will also be collected.


Eligibility criteria:
inclusion criteria * females and males ≥ 18 years of age. * understands the procedures and agrees to participate by giving written informed consent. biopsy group only: • scheduled for standard of care liver biopsy for any reason. non-biopsy group only: • bmi ≥ 25, with or without type 2 diabetes, without any level of nafld based on: (1) recent medical history (within 6 months of screening visit). (2) data collected from participation in a prior research study where they consented to be re-contacted for future studies. exclusion criteria * women who are pregnant when referred for a liver biopsy will be excluded. * presence of any condition that, in the opinion of the investigator, compromises participant safety or data integrity or the participant's ability to complete the study. otherwise, all eligible patients who consent will be included in avail. if participants in the non-biopsy group are found to have nafld based on the fibroscan done for this study, then they will be informed of this and advised to follow up with their physician. their data will still be part of the registry and analyzed with the biopsy group that is found to have nafld.

Keywords: nafld
a study to assess neuroendocrine tumour (net) patients currently treated by somatuline autogel for history of carcinoid syndrome associated with episodes of diarrhea

Conditions: Neuroendocrine Tumors; Carcinoid Syndrome

Summary: the purpose of the protocol is to to assess subject's overall satisfaction regarding control of diarrhea. the study aims to supplement results obtained through clinical trials with data obtained from a population of patients receiving treatment with somatuline autogel in routine practice.


Eligibility criteria:
inclusion criteria: * out-patients 18 years of age and older, who have agreed to participate in the study * diagnosed with a neuroendocrine tumour (net) and receiving treatment with somatuline autogel exclusion criteria: * subjects for whom there are reasons that may hinder the conduct of the study (patients who have difficulty expressing themselves or who are unable to complete the questionnaires, or with insufficient data in the their files will not be enrolled in the study).
safety of sildenafil in premature infants

Conditions: Bronchopulmonary Dysplasia

Summary: describe the safety of sildenafil in premature infants at risk of bronchopulmonary dysplasia and determine preliminary effectiveness and pharmacokinetics (pk) of sildenafil. funding source - fda oopd.

this will be a multi-center, randomized, placebo-controlled, sequential dose escalating, double masked, safety data study of sildenafil in premature infants. this is a phase ii study design, premature infants (inpatient in neonatal intensive care units) will be randomized in a dose escalating approach 3:1 (sildenafil: placebo) into 3 cohorts with escalating doses of sildenafil. there will be 40 randomized and dosed participants in each cohort for a total of up to 120 participants. cohort 1 sildenafil dose will be 0.125 mg/kg q 8 hours iv or 0.25 mg/kg q 8 hours enteral. cohort 2 sildenafil dose will be 0.5 mg/kg q 8 hours iv or 1.0 mg/kg q 8 hours enteral. cohort 3 sildenafil dose will be 1 mg/kg q 8 hours iv or 2 mg/kg q 8 hours enteral.

Eligibility criteria:
inclusion criteria: * receiving positive airway pressure (nasal continuous airway pressure, nasal intermittent positive pressure ventilation, or nasal cannula flow \> 1lpm) or mechanical ventilation (high frequency or conventional) * \<29 weeks gestational age at birth * 7-28 (inclusive) days postnatal age at time of randomization exclusion criteria: * currently receiving vasopressors * currently receiving inhaled nitric oxide * baseline mean arterial pressure \< gestational age (in weeks) plus postnatal age (in weeks) within 2 hours of sildenafil administration * known allergy to sildenafil * known sickle cell disease * ast \> 225 u/l \< 72 hours prior to randomization * alt \> 150 u/l \< 72 hours prior to randomization
allogenic transplantation of ex-vivo expanded cord blood (cb)

Conditions: Umbilical Cord Blood; Stem Cell Transplantation; Hematological Malignancies

Summary: the aim of this study is to evaluate the safety profile and tolerability of infusion of cord blood cells expanded in the lab and to evaluated whether through the infusion of expanded cells it is possible to expedite engraftment time after transplantation.

stem cell transplantation is a curative approach for patients with hematological malignancies. umbilical cord blood is a source of stem cells for transplantation in patients with no related donor. however, in adults, the number of stem cells in a single unit, may be too low to allow engraftment, and the time to engraftment may be prolonged, increasing the risks of the transplant. in this study, we expand part of the cord blood unit, in the lab, trying to increase unit size, such that it would be suitable for adults, and would allow safe engraftment.

Eligibility criteria:
inclusion criteria: * age \> 18 years * hematological malignancy * standard indication for allogeneic transplantation * expected survival time over 12 weeks * no related or unrelated donor * availability of a cord blood unit of compatible placental blood cryopreserved in at least 2 different bags; one of the two units should have a cellular content at least equal to the minimum dose of 2 x 107 nucleated cells per kilogram of body weight exclusion criteria: * eastern cooperative oncology group (ecog) performance status \>2 * prior allogeneic transplantation * pregnant or nursing women * positive serology for hepatitis b or c * hiv positive * left ventricular ejection fraction \< 50% * dlco \< 50% * psychiatric, addictive, or any disorder/disease which compromises ability to give informed consent for participation in this study * treatment with other investigational drugs within 4 weeks of enrolling in this protocol

Keywords: umbilical cord blood ex vivo expansion engraftment gvhd
venlafaxine for postoperative pain of laparoscopic cholecystectomy

Conditions: Laparoscopic Cholecystectomy

Summary: recent studies on the impact of perioperative venlafaxine for treatment of acute postoperative pain have yielded positive outcomes . the aim of the present study is to investigate the role of perioperative venlafaxine on the management of postoperative pain in patients undergoing lc.


Eligibility criteria:
inclusion criteria: * 1. patients who are scheduled to undergo elective lc exclusion criteria: 1- patients with acute pancreatitis 2. patients undergoing chronic pain treatment 3. patients who received analgesics or sedatives 24 h before scheduled surgery 3. patients had alcohol or drug addiction 4. severe hepatic and renal dysfunction 5. previous allergic response to duloxetine 6. pregnancy and lactation 7. patients with communication problems, cognitive dysfunction, or psychological disorders
relationship between gut microbiome and adjuvant chemotherapy in patients with early breast cancer

Conditions: Breast Cancer; Adjuvant Chemotherapy

Summary: breast cancer is the most common cause of cancer death in women. adjuvant chemotherapy significantly reduces the risk of recurrence of high-risk breast cancer. however, about 30% of patients still have distant metastasis or local recurrence after chemotherapy. moreover, 60% of patients had 3-4 degrees of adverse drug reactions during chemotherapy. the purpose of the study is to investigate relationship between gut microbiome and adjuvant chemotherapy in early breast cancer patients.

breast cancer is the most common cause of cancer death in women. adjuvant chemotherapy significantly reduces the risk of recurrence of high-risk breast cancer. however, about 30% of patients still have distant metastasis or local recurrence after chemotherapy. moreover, 60% of patients had 3-4 degrees of adverse drug reactions during chemotherapy. the human gut microbiota have been considered the most important microecosystem living in symbiosis with the body. it is identified as a crucial determinant in cancer occurrence and development . besides, gut microbial alterations may influence the therapy efficacy and adverse drug event. we collect the fresh tail stool sample 24h before adjuvant chemotherapy and 24h after adjuvant chemotherapy then the composition of intestinal microbiota and subsequent short-term alterations are analysed by 16srrna sequencing.the purpose of the study is to investigate relationship between gut microbiome and adjuvant chemotherapy in early breast cancer patients.

Eligibility criteria:
inclusion criteria: * histologically diagnosed stage i-iii breast cancer; * plan to receive adjuvant chemotherapy in our hospital; * sign the informed consent; * good compliance and willing to follow up. exclusion criteria: * those who have started receiving adjuvant chemotherapy; * chemotherapy contraindications;
internet-based vs face-to-face cognitive behavioural therapy for obsessive-compulsive disorder

Conditions: Obsessive-compulsive Disorder

Summary: randomized controlled non-inferiority trial comparing therapist-guided internet-based cognitive behavioral therapy (icbt), self-guided icbt, and individual face-to-face (f2f) cbt for obsessive-compulsive disorder (ocd) in adults. the primary objective is to evaluate whether icbt is a non-inferior treatment option compared to the best possible available treatment for ocd, individual face to face (f2f) cbt. a second objective is to compare the efficacy of self-guided vs. therapist-guided icbt. as this question has cost implications for the health system, a third objective is to carry out a health economic evaluation of both forms of icbt, in relation to the gold standard f2f cbt. a fourth objective is to explore whether icbt is equally suited for clinic-referred cases compared to self-referred patients. finally, a fifth objective is to investigate whether genetic markers, in combination with clinical variables, can be employed to predict treatment outcomes with cbt in general. research questions: q1: is therapist-guided internet-based cbt (icbt) for ocd non-inferior to face-to-face (f2f) cbt with regard to ocd symptoms, function and quality of life? q2: is entirely self-guided icbt non-inferior to f2f cbt with regard to ocd symptoms, function and quality of life? q3: is icbt a cost-effective treatment, compared to f2f cbt? q4: is there a difference in treatment outcome between self-referred and clinical referred patients? q5: can clinical variables and genetic markers be useful to predict which patients will benefit from cbt?


Eligibility criteria:
inclusion criteria: * ≥ 18 years of age, * internet access, * primary diagnosis of ocd according to the diagnostic and statistical manual of mental disorders, fifth edition (dsm-5), * written consent of participation in the study. exclusion criteria: * other psychological treatment for ocd during the treatment period, * adjustment of concurrent psychotropic medication within the last two months, * bipolar disorder, * psychosis, * alcohol or substance dependence, * completed cbt for ocd in the last 12 months, * hoarding disorder or ocd with primary hoarding symptoms, * suicidal ideation, * subjects that lack the ability to read written swedish or lack the cognitive ability to assimilate to the written material, * autism spectrum disorder, * organic brain disorder.
effect of cannabinoids on spasticity and neuropathic pain in spinal cord injured persons

Conditions: Muscle Spasticity as a Result of Spinal Cord Injury

Summary: this study is being conducted to study the effect of nabilone (a synthetic cannabinoid)on spasticity in spinal cord injured persons.the study will be a phase 2, randomized, placebo-controlled crossover study. each eligible subject will participate for 26 weeks.subjects will be randomized to receive either nabilone or placebo during phase 1 of the study. study drug will be titrated up from 0.5mg daily to a maximum of 3.0 mg daily over the first 11-week phase. following a 4-week washout period, subjects will be crossed-over to the opposite arm for another 11 week treatment period (phase 2).


Eligibility criteria:
inclusion criteria: * spinal cord injury * 12 months post -injury * c2-t12, asia a-d, stable level of injury * moderate to severe spasticity or moderate to severe neuropathic pain * no cognitive impairment * spasticity medications unchanged for at least 30 days or inadequate pain control at a stabilized dose of either gabapentin or pregabalin for at least 30 days * no botulinum toxin injections x 6 months exclusion criteria: * significant cardiovascular disease * major illness in another body area * history of psychological disorders or predisposition to psychosis * sensitivity to cannabinoids * severe liver disfunction * history of drug dependancy * fixed tendon contractures * used cannabis in the past 30 days * unwilling to refrain from smoking cannabis during the study * pregnant or nursing mother

Keywords: spasticity, spinal cord injury
comprehensive cardiac rehabilitation feasibility after stroke

Conditions: Stroke, Ischemic

Summary: comprehensive cardiovascular rehabilitation feasibility after stroke (ccr fast) will evaluate the feasibility of enrolling regions hospital stroke patients in a comprehensive cardiovascular rehabilitation (ccr) program. ccr will include aerobic exercise and patient education (regarding risk factors and medication compliance), similar to the rehabilitation program for cardiac disease patients. the overall goal of ccr fast is to demonstrate the feasibility and safety of including stroke patients in a ccr program, while examining the clinical value in reducing stroke recurrence, myocardial infarction, readmission, and mortality in stroke patients.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * patient has suffered an ischemic stroke * patient should be ambulatory (non-disabling stroke) to be able to participate in the ccr exercise program * patient is able to start cardiac rehabilitation within 2 weeks of stroke exclusion criteria: * no baseline (index admission for ischemic stroke) mri completed * life expectancy \< 1-year * presence of brain hemorrhage: intracerebral hemorrhage, subarachnoid hemorrhage, subdural hematoma, or epidural hematoma * concurrent diagnosis of seizure disorder * patient with moderate or severe neurologic deficits, limiting their ability to participate in the ccr exercise program * cardiopulmonary conditions preventing the patient from participation, such as severe heart failure, severe aortic stenosis, and exercise-induced asthma * patient with cognitive dysfunction impairing their ability to follow directions * anticipated procedures such as carotid stenting, carotid endarterectomy, and intracranial aneurysm coiling * patient unable to commit to the frequent visits of the ccr program * participation in other interventional research (observational research is allowed) * unable to have brain mri * non-english speaker * pregnant women