Kornimate/medical-research-clean huggingface dataset:
oral zinc therapy for the prevention of mucositis

Conditions: Mucositis

Summary: zinc is an intracellular mineral with important enzymatic cofactor activities for cell membrane stability, dna and rna structure. zinc deficiency is associated with delayed wound healing and immune dysfunction. in patietns with hematological malignancies an inverse correlation was found between disease stage and zinc level. patients undergoing high dose chemotherapy for hematologic malignancies are predisposed to develop oral and gastrointestinal complications, in particular oral mucositis. these patients may have relative zinc deficiency, therefore oral zinc therapy may be benefical in the prevention of these complications.

patients candidate for high dose chemotherapy with stem cell support for the diagnosis of relapsed/resistant hodgkins or nhl or mm will be screened for enrollment in the study. patients will be randomized in a 1:1 ratio to therapy with either zincol 1 tab tid or placebo 1 tab tid. therapy will start on the morning before commencing chemotherapy and will continue untill the first of either discharge day or day 21. response assesment will include: 1. mucositis assesment using nci-ctc and omas scores- to be done eod from baseline and untill day 21/discharge day if before day 21 2. evaluation of zinc levels in the serum, pbmc and saliva- to be done at baseline, day 6/7 and day 21/discharge day if before day 21. 3. collection of clinical outcome data regarding infectious complications including- presence and length of febrile neutropenia,use of antibacterial and antifungal medications,

Eligibility criteria:
inclusion criteria: * patients undergoing high dose chemotherapy with stem cell support for relapsed or resistant hodgkins or nhl (treated with beam protocol) or mm (treated with high dose melphalan). * ecog performance less than or equal to 2 * adequate renal and hepatic function exclusion criteria: * presence of any other active malignancy other than bcc of the skin

Keywords: stem cell transplantation mucositis zinc
a study with self-administered rocatinlimab in adolescent and adult participants with moderate-to-severe atopic dermatitis

Conditions: Atopic Dermatitis

Summary: the primary objective of this study is to assess successful self-administration of rocatinlimab subcutaneously using devices for injection.


Eligibility criteria:
inclusion criteria: * age ≥ 12 at day 1. * diagnosis of ad according to american academy of dermatology (aad) consensus criteria (2014) that has been present for at least 12 months. * history of inadequate response to topical corticosteroids (tcs) of medium to higher potency (with or without topical calcineurin inhibitors \[tci\]). * validated investigator global assessment for atopic dermatitis (viga-ad™) score ≥ 3 at screening and pre-randomization. * eczema area and severity index (easi) score ≥ 16 at initial at screening and pre-randomization. * ≥ 10% body surface area (bsa) of ad involvement at screening and pre-randomization. exclusion criteria: * treatment with a biological product within 12 weeks or 5 half-lives, whichever is longer, prior to day 1 pre-randomization. * treatment with any of the following medications or therapies within 5 half-lives prior to day 1 pre-randomization: 1. systemic corticosteroids 2. non-biologic, non-targeted systemic immunosuppressants 3. oral or topical janus kinase inhibitors * treatment with any of the following medications or therapies within 1 week before day 1 pre-randomization: 1. topical phosphodiesterase 4 (pde4) inhibitors 2. other topical immunosuppressive agents (not including tcs/tci) 3. combination topical agents containing any of the above components
ultrasound guided thoracic paravertebral block for percutaneous nephrolithotomy operations in children

Conditions: Postoperative Pain

Summary: the investigators aimed to evaluate the effect of ultrasound guided thoracic paravertebral block with bupivacaine on both perioperative anesthetic agent consumption and postoperative analgesia in pediatric patients undergoing percutaneous nephrolithotomy for kidney stone.

this study was performed after approval of ethics committee and parents written consent. between the ages 1-5, planned percutaneous nephrolithotomy due to kidney stones 40 patients were enrolled in this study, and patients were randomly divided into two group. all patients were performed general anaesthesia. the group i patients was given ultrasound guided thoracic paravertebral block with 0.5 ml/kg bupivacaine %0.5 after giving prone position and the group ii patients was given 15 mg/kg of paracetamol as postoperative analgesia. in the period of postoperative, if the flacc \> 4; it was planned to dose 1 mg/kg of tramadol. patients' hemodynamic parameters, oxygen saturation, sevoflurane concentration were recorded 10, 15, 30 and 60 minutes intraoperatively. patients' hemodynamic parameters, oxygen saturation, pain scores (flacc), satisfaction of parents, the number of patients who additional analgesic requirements and side effects (nausea,vomiting, hypotension, bradycardia, respiration problems etc) were recorded in the postoperative period. primary outcome measures was pain scores using flacc scale.

Eligibility criteria:
inclusion criteria: * asa physical status i-ii * between the ages of 1-5 years * forty children exclusion criteria: * refusals by parents * children with spine deformities * cutaneous infection * bleeding diathesis * allergy to drugs used * asa physical status iii-iv
promaster - prospective cohort mrc abpi stratification and extreme response mechanism in diabetes

Conditions: Diabetes

Summary: this study will examine extreme responders to second- and third-line type 2 diabetes therapy using a prospective approach, and patients with slow or fast diabetes progression using a retrospective approach.

pilot phase (march 2013 - dec 2014) participants will be recruited initially from 4 centres. patients due to start second- and third-line type 2 diabetes treatments, and patients progressing to insulin either particularly quickly or particularly slowly, will be recruited from primary care, secondary care, or community settings. fasting blood and urine samples will be collected, together with standard biomeasures and information about medical history and prescribing history. participants in responders arm will be contacted by telephone approximately 3 months after starting their new second/third-line agent to review their current medication and blood glucose level. if a 3 month hba1c has not been collected as part of routine clinical care, the research team will arrange this. participants will be asked to return for a blood and urine test approximately 6 months after their new treatment was started. this visit will be brought forward should the participant advise they are about to further change their treatment, to enable their samples to be collected in advance of their proposed treatment change. all study documentation and sample materials will be distributed to sites from the coordinating centre. sites will be expected to process and freeze samples and send them to the chief investigator's central laboratory where they will be analysed for genetic factors, glycaemic markers and other markers related to drug response. post-pilot phase (jan 2015 - oct 2017) subject to feasibility, interim analysis and continuation of funding from medical research council (mrc), this study will continue for another 3 years.

Eligibility criteria:
inclusion criteria: * demographics: age 18-90 inclusive * ethnicity: reflective of local demographic * medical history: clinical diagnosis of type 2 diabetes * mental capacity: capacity to consent exclusion criteria: * age less than 18 years old and greater than 90 years old * incapacity to consent * type 1 diabetes.

Keywords: diabetes type 2 diabetes diabetes therapy response diabetes progression
sodium (23na) mri for tumour characterisation and assessment of therapy response in breast cancer

Conditions: Breast Cancer

Summary: the scope of this study is the methodological development and optimisation of sodium mri (23na-mri) protocols for breast cancer imaging. the study further proposes to utilise biomarkers obtained from 23na-imaging (cell integrity), fdg-pet (metabolism), multi-parametric mri (perfusion, vascularity, cellularity, morphology) to generate parameter maps specific for physiological processes in breast cancer.

this is a prospective, non-randomised, exploratory study on ≤20 healthy female volunteers (\>18 years), and ≤45 female patients (\>18 years) diagnosed with primary breast cancer. healthy volunteers (n≤20) will be scheduled to undergo an 23na-mr examination. patients scheduled for primary surgery (n≤30) will undergo a single mr examination, involving 23na-imaging prior to their planned surgery. immunohistochemical analysis will be performed on surgical tissue specimens to determine tissue markers of interest for correlation with the imaging findings. patients undergoing neo-adjuvant therapy (n≤15) will undertake up to two (2) combined pet/mr examinations with fdg (18f-2-fluoro-2-deoxy-d-glucose) and 23na-mri. patient imaging will occur at two time points prior to their planned surgery: (i) baseline (prior to initiation of treatment) and (ii) mid-treatment (after 3-4 cycles of chemotherapy). histopathological analysis will be performed on pre-treatment biopsies for histological markers of interest for correlation with the imaging findings.

Eligibility criteria:
inclusion criteria: healthy volunteers * female, aged 18 years or above * participant is willing and able to give informed consent for participation in the study. patients * female, aged 18 years or above * pathologically confirmed primary breast cancer * tumour \>1 cm diameter on mammography and/or ultrasound. exclusion criteria for healthy volunteers and patients: * pregnant or lactating; * history of serious breast trauma within past 3 months * implants known to be contraindicated at 3t mri * significant or uncontrolled medical problems which according to the opinion of the principal investigator render the participant unsuitable for participation in the study * underlying conditions, including but not limited to medical or psychiatric conditions, which in the opinion of the principal investigator would preclude the participant from adhering to the study protocol or completing the study per protocol * lacking the capacity to provide informed consent. additional exclusion criteria for patients * has undergone chemotherapy or hormonal therapy for breast cancer in the previous 12 months * previous surgery or radiotherapy for breast cancer to the ipsilateral breast within the past 4 months * previous surgery for benign breast disease within the past 4 months * history of kidney disease or known allergic reaction to gadolinium contrast agent.
ketamine as an adjuvant therapy for acute vaso occlusive crisis in pediatric patients with sickle cell disease

Conditions: Sickle Cell Disease

Summary: the primary objective of the proposed study is to determine the potential role of ketamine as an analgesic agent in pediatric sickle cell disease patients with refractory symptoms in acute (voc).

the primary objective of the proposed study is to determine the potential role of ketamine as an analgesic agent in pediatric sickle cell disease patients with refractory symptoms in acute (voc). our study design is as follows: prospective observational study of 20 pediatric sickle cell disease patients with refractory pain to conventional analgesic regimens seen in the pediatric emergency medicine department. consenting patients with refractory pain meeting inclusion criteria will be given a single intravenous bolus of ketamine at a set dosage of 0.25 milligrams per kilogram of weight. participants' perception of pain will then be recorded using standard pain scoring scales (flacc score). physiologic criteria such as heart rate, blood pressure, blood oxygen saturation, total analgesic pharmacologic requirements for adequate analgesia during hospitalization, and duration of hospitalization will be measured. observational study group will continue to get standard of care outside of single bolus of ketamine. 48 hour follow up after hospital discharge will be obtained to assess degree of pain control and general clinical status.

Eligibility criteria:
inclusion criteria: * pediatric patients (\> 3 yrs and \<18yrs) with a previous diagnosis of sickle cell disease (including hgb s beta thalassemia +, hgb s alpha thalassemia, hgb s hpfh) ) seen in the pediatric emergency room setting for acute vaso-occlusive pain crisis. exclusion criteria: * patients not to have sequelae indicative of complicated disease outside of acute voc: 1. acute chest syndrome (new pulmonary infiltrate and hypoxemia) 2. aplastic episode 3. evidence of infection 4. pregnancy or chf 5. fever (\> 38.4) 6. cholangitis or cholecystitis 7. hypoxia (sao2 \<90% on ra), or o2 saturation decrease of more than 5% from patient's baseline 8. unstable vital signs 9. patients who have received intravenous pain medicine within 24 hours of visit to the emergency department. 10. history of allergic reaction or serious reaction to ketamine. 11. history of significant psychiatric illness 12. patients with no refractory pain after receiving conventional analgesia regimen per protocol.
propofol versus sevoflurane on acute postoperative pain

Conditions: Postoperative Pain

Summary: this study was performed to compare the acute postoperative pain intensity and opioid consumption after total shoulder arthroplasty between propofol-remifentanil and sevoflurane-remifentanil anesthesia.

after approval of the institutional review board and written informed consent, 48 patients, aged 18-65 years for shoulder arthroplasty were enrolled in this prospective, randomized, double-blinded study. patients were assigned to one of two groups : group pr, the propofol-remifentanil group; and group sr, the sevoflurane-remifentanil group. in the group pr, anesthetic induction was achieved with an initial target concentration of propofol 4 ㎍/ml and remifentanil 3-4 ng/ml using target controlled infusion (tci) devices and rocuronium 0.8 mg/kg. after intubation, anesthesia was maintained with fixed target concentration of propofol 2-4 ㎍/ml and remifentanil 2-3 ng/ml to keep acceptable hemodynamic response and bispectral index (bis) values 40-60. in the group sr, anesthetic induction was achieved with thiopental 5 mg/kg and initial target concentration of remifentanil 3-4 ng/ml using tci and rocuronium 0.8 mg/kg. anesthesia was maintained with 1.5-2.5% end-tidal concentration sevoflurane in 50% oxygen with air and remifentanil 2-3 ng/ml was continuously infused adjusting to maintain an acceptable hemodynamics and bis values 40-60. the administration of propofol or sevoflurane with remifentanil was stopped at the surgery ended. postoperative pain intensity was assessed using a numerical rating scale (nrs: 0; no pain, 10; worst pain) at the 30 min, 2, 6, 12, 24 h. also, the patient-controlled analgesia (pca) was infused immediately after post anesthetic care unit arrival. the pca device was set to deliver 0.38 ㎍/kg/h of fentanyl as a basal infusion rate and 20 ㎍ on demand with a 15 min lockout time. the total pca volume, number of patients to need rescue analgesics was recorded.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists (asa) i or ii and aged 18-65 years for total shoulder arthroplasty exclusion criteria: * use of routinely using analgesics, history of neurologic or psychologic disease, body mass index more than 35 kg/m2, and intake of any sedatives or analgesics within 24 h before surgery

Keywords: propofol sevoflurane anesthesia shoulder arthroplasty
prospective multicenter registry on radiation dose estimates of cardiac ct angiography in daily practice in 2017 (protection vi)

Conditions: Coronary Artery Disease; Coronary Disease; Myocardial Ischemia; Arterial Occlusive Diseases; Arteriosclerosis

Summary: background: ccta is a common way to evaluate coronary artery disease. it stands for coronary computed tomography angiography. it uses scanning to look at the arteries that supply blood to the heart. it is noninvasive, widely available, and generally accurate. but it does expose people to radiation. exposure to high amounts of radiation can increase a person s risk of getting cancer. researchers want to learn more about the relationship between ccta and radiation exposure. objective: to see how much radiation is used to take pictures of the heart and how measures to reduce radiation are used around the world. eligibility: people ages 18 years and older who need a computed tomography (ct) scan of the heart design: participants will be screened with a review of their medical records. participants may have a pregnancy test. participants will have the scheduled scan. small, sticky discs will be placed on the chest. a small tube will be placed into a vein in the arm. a contrast material (dye) will be given through it. participants will lie on the ct scanning table. a ccta scan usually takes about 15 minutes if the heart rate is slow and steady.

cardiac ct angiography is a commonly used test to take detailed pictures of the heart to diagnose heart disease; however, it is associated with radiation exposure. several technological advances in both scanner hardware and software are now available to reduce the radiation exposure to patients. the purpose of this study is to evaluate the worldwide usage of these radiation dose saving strategies in daily practice and analyze their effect on image quality.

Eligibility criteria:
* inclusion criteria: 1. clinical indication for cardiac ct angiography to evaluate coronary arteries or other cardiac structures 2. age equal to or greater than 18 years 3. able to understand and willing to sign the informed consent form exclusion criteria: 1) female participants who are pregnant or nursing

Keywords: cardiac computed tomography radiation iterative reconstruction natural history
a study to compare the amount of tasocitinib (cp-690,550) that is absorbed into the blood of healthy subjects following oral administration of three different tablet versions of tasocitinib (cp-690,550)

Conditions: Rheumatoid Arthritis

Summary: in this study, a 10 mg dose of tasocitinib (cp-690,550) will be given to study subjects on three separate occasions using one of three different tablet formulations (tablet versions) each time. the amount of tasocitinib (cp-690,550) available in the blood following administration of each tablet formulation will be measured and compared. the overall aim of the study is to establish that a similar amount of tasocitinib (cp-690,550) is absorbed into the blood following administration of the same dose of each different tablet formulation.

this is a pivotal bioequivalence study for tasocitinib (cp-690,550).

Eligibility criteria:
inclusion criteria: * healthy male and/or female (non-childbearing potential) subjects between the ages of 21 and 55 years, inclusive. * body mass index (bmi) of 17.5 to 30.5 kg/m2; and a total body weight for males\>50 kg (110 lbs). for females, total body weight \>45 kg (99 lbs). * no evidence of active or latent or inadequately treated infection with mycobacterium tuberculosis (tb). exclusion criteria: * evidence of any clinically significant illness, medical condition, or disease. * evidence or history of any clinically significant infections within the past 3 months. * use of tobacco- or nicotine-containing products in excess of the equivalent of 5 cigarettes per day.

Keywords: bioequivalence healthy volunteer study rheumatoid arthritis
the biology of hiv transmission

Conditions: HIV Infections

Summary: the purpose of this study is to look at the amount of hiv in the blood, genital fluid, and saliva of the partners of patients with early hiv infection. this study will also look at the strength of the immune systems of patients with early hiv infection. because hiv multiplies very quickly in the early stages of infection, patients with early hiv infection may be more likely to transmit hiv to their partners. the amount of hiv in blood, genital fluid, and saliva may determine the risk for transmission.

persons with early hiv infection may represent high transmission risk to their partners. early infection, characterized by rapid virologic replication, insufficient immunologic control of infection, and more rapid course of disease progression, may be associated with increased infectiousness. the viral determinants of transmission may in part be explained by viral burden in blood, genital fluids, and oral cavity fluids. all three fluids may be the source for transmitted virus. persons with suspected hiv infection are asked to identify their possible source partners. the importance of partner referral is emphasized and assisted recruitment or active tracing is offered if necessary. source partners will not be approached uninvited. if a partner states that he/she does not want to be contacted, then he/she will not be contacted further for the purpose of this study or for any other study. all patients are offered hiv counseling and plasma testing for hiv-1 rna and cd4+ cells. blood specimens are collected for plasma determination, and cellular and plasma fractions are collected for caf and neutralization antibodies. neutralization assays are used to detect humoral immune response in patients with primary hiv infection. genital fluids and saliva are analyzed for viral rna. patients are seen in the clinic on day 1 for blood draw and return 2 weeks later for blood test results. a follow-up period of at least 4 weeks is planned. compensation is provided to all patients.

Eligibility criteria:
inclusion criteria patients may be eligible for this study if they: * are at least 18 years old. * have sex with or share injection drugs with a person who is thought to have early hiv infection, or if they have recently become hiv-positive. * can provide written consent. * are available for a follow-up period of at least 4 weeks.

Keywords: semen hiv-1 sexual partners drug resistance, microbial cd8-positive t-lymphocytes saliva blood cervix uteri vagina acute infection