Kornimate/medical-research-clean huggingface dataset:
combination of inhaled dnase, baricitinib and tocilizumab in severe covid-19

Conditions: COVID-19 Severe Respiratory Failure

Summary: in patients with covid-19, severe hypoxemic respiratory failure (srf) leading to invasive mechanical ventilation (imv), raises the mortality rate substantially. thus, the management of patients with srf to avoid intubation and intensive care admission is a challenging and crucial issue. this study describes, as rescue/compassionate treatment, a therapeutic protocol based on the multi-mechanistic nature of severe covid-19, using the combination of inhaled dnase, baricitinib and tocilizumab on top of standard of care (soc) consisting of heparin and dexamethasone. covid-19 patients with srf who were treated with soc, soc plus anakinra (ana), and soc plus tocilizumab (toci) will be studied as comparators. primary endpoint will be the reduction of the in-hospital mortality rate, whereas secondary endpoints concern intubation rate, days of hospitalization and overall survival as derived from the last follow-up visit, either in-office or remote. this is a non-randomized, open-label, study, conducted in the first department of internal medicine, university hospital of alexandroupolis, greece.


Eligibility criteria:
inclusion criteria: 1. adult patients ≥18 years old, of any gender 2. positive polymerase-chain-reaction (pcr) test for sars-cov-2 rna in nasopharyngeal swab 3. pulmonary infiltrates suggestive of covid-19 4. severe respiratory failure (srf) as defined by pao2/fio2\<100 mm hg 5. written informed consent from the patients or legal representatives for the current compassionate therapeutic protocol. exclusion criteria: 1. need for intubation/imv during the first 24 hours after the initiation of treatment 2. multi-organ failure, 3. systemic co-infection 4. srf due to cardiac failure or fluid overload 5. glomerular filtration rate (gfr) \<30 ml/min/1.73 m2) 6. any stage iv solid tumor or immunosuppression due to hematological disorders 7. any immunosuppressive therapy and/or chemotherapy during the last 30 days 8. low patient's functional performance as defined by a palliative performance scale (pps) score ≤30% 9. pregnancy.

Keywords: covid-19 respiratory failure inhaled dnase baricitinib tocilizumab low molecular weight heparin dexamethasone anakinra
phase 1 study of ds-6051b in japanese subjects with advanced solid malignant tumors

Conditions: Advanced Solid Malignant Tumors

Summary: this is a phase 1 study to evaluate the safety, tolerability, and pharmacokinetics of ds-6051b in japanese subjects with advanced solid malignant tumors harboring either a ros1 or ntrk fusion gene.

this study is single arm study with ds-6051b in approximately 9 subjects with advanced solid malignant tumors harboring either a ros1 or ntrk fusion gene. safety and tolerability, pharmacokinetics (pk), maximum tolerated dose/recommended phase 2 dose (mtd/rp2d) and preliminary efficacy of ds-6051b will be evaluated.

Eligibility criteria:
inclusion criteria: * advanced solid malignant tumors that are refractory to standard therapy or for which no standard therapy is available. * an eastern cooperative oncology group (ecog) performance status (ps) 0-1. exclusion criteria: * previously had or currently has any of the following diseases: cardiac failure (nyha functional classification ≥ class iii), myocardial infarction, cerebral infarction, unstable angina, arrhythmia requiring treatment, coronary/peripheral artery disease, pulmonary thrombosis, uncontrolled deep vein thrombosis, clinically severe thromboembolic event, or autoimmune disease requiring treatment. * previously had or currently has clinically severe pulmonary disease (eg, interstitial pneumonia, pneumonitis, pulmonary fibrosis, radiation pneumonia). * severe or uncontrolled concomitant disease. * clinically active brain metastases or central nervous system tumor requiring steroid or anticonvulsant treatment.

Keywords: advanced solid tumor ds-6051b ros1 ntrk refractory to standard therapy no standard therapy
motor outcomes to validate evaluations in fshd (move fshd)

Conditions: FSHD

Summary: the primary goal of this proposal is to collect motor and functional outcomes specific to fshd over time. by collecting measures specific to fshd, this will help ensure the best level of clinical care is being provided. also, the hope is to speed up drug development by gaining a better understanding of how having fshd impacts motor function and other health outcomes (i.e. breathing, wheelchair use, etc.) and how big a change in motor function would be clinically meaningful to those with fshd. motor outcomes to validate evaluations in fshd (move fshd) will have approximately 450 fshd participants followed for a minimum of 3 years. a subset of move fshd participants, approximately 200, will participate in the move+ sub-study which includes whole body mri and reachable workspace, as well as optional muscle biopsy and wearable device (us participants only).


Eligibility criteria:
inclusion criteria: * genetically confirmed fshd (types 1 or 2) or clinical diagnosis of fshd with characteristic findings on exam and an affected parent or offspring. exclusion criteria: * unwilling or unable to provide informed consent. * any other medical condition which in the opinion of the investigator would interfere with study participation.
endometriosis and psychological support

Conditions: Endometriosis

Summary: endometriosis is a common disease, causing significant pain (dysmenorrhea, dysuria, dyspnea, dyspareunia, and chronic pelvic pain) and infertility, drastically reducing patients' quality of life. endometriosis surgery is often a stressful event for the patient. for that reason, psychological support can improve patients' general health state.

patients with clinical and trans-vaginal / abdominal ultrasound diagnosis of endometriosis, undergoing surgery for the removal of endometriotic lesions are included in the study. psychological support is offered to all women one month before and one month after surgery. a group of patients will receive intensive psychological support during hospitalization. patients are divided into 2 groups: group a: patients receiving intensive psychological support during hospitalization group b: patients not receiving intensive psychological support during hospitalization after surgery, patients will be included in the post-operative follow-up, as usual in the investigator's clinical practice.

Eligibility criteria:
inclusion criteria: * patients undergoing surgery for endometriosis * patients that have signed an informed consent exclusion criteria: * patients with active or history of psychological/psychiatric diseases * patients that refuse psychological support

Keywords: endometriosis psychological support
hyperbaric oxygen for carbon monoxide induced chronic encephalopathy

Conditions: Carbon Monoxide Poisoning; Chronic Encephalopathy

Summary: in some patients, a few days or weeks after recovery from carbon monoxide poisoning, new symptoms develop. these can affect mood, ability to think or remember clearly, and movements. some people develop movement problems that are similar to parkinson's disease. this damage to brain tissue is called "encephalopathy," and this study will look at the effect of pressurized oxygen therapy on long term, or chronic, encephalopathy.

carbon monoxide (co) poisoning is a leading cause of unintentional poisoning deaths in the united states. after a period of apparent recovery, survivors of acute co-poisoning can develop a potentially permanent neurologic deterioration (dns). dns is a rare, poorly known encephalopathy with a 25-50% prevalence among severely poisoned co-poisoned patients. its symptoms and signs range from subtle abnormalities to severe dementia, parkinsonism, gait disturbances, mutism, and incontinence. recovery from delayed neuropsychiatric syndrome occurs in 50-75% of patients within 1 year. however, this leaves 25-50% permanently impaired. hyperbaric oxygen therapy (hbo2) is useful after acute poisoning to reduce the chance of developing dns. however, appropriate therapy for dns is widely debated; particularly, the role of hyperbaric oxygen therapy (hbo2) after dns has developed is controversial. this study proposes to ascertain whether hyperbaric oxygen is efficacious in the treatment of chronic dns brain injury from carbon monoxide (co) poisoning. ten participants suffering from dns for longer than one year will be recruited to the study, which will be prospective, blinded, sham-controlled and crossover in design. participants will be divided into two groups of five. one group will receive 40 hbo2 treatments \[100% oxygen at twice normal air pressure (2 ata)\] followed by 40 sham hbo2 treatments \[air at near normal pressure (1.2 ata)\]. treatments will be done once daily for 2 hours, monday through friday. neurological and psychologic assessments will be done prior to starting treatments, after each group of 40 treatments. the second group will be treated similarly except that they will receive sham treatments in the first and oxygen treatments second. in this manner, all participants will act as both experimental and control subject and will receive treatment which we believe is therapeutic.

Eligibility criteria:
inclusion criteria: * co induced neurological or cognitive sequelae assessed as at least mild (e.g. updrs part 3 (motor)\>15). * chronicity- signs or symptoms present for greater than one year after exposure. exclusion criteria: * age \>90 or less than 10 years * other morbidities which may contribute to chronic neurocognitive deficits (such as traumatic brain injury, poisoning by other toxins, other neurodegenerative diseases) * pregnancy (if a subject becomes pregnant she will be removed from the study) * routine contraindications to hyperbaric oxygen
comparison of creatinine clearance calculation for estimation of gfr in patients receiving hd methotrexate

Conditions: CNS Lymphoma; CNS Involvement of Systemic Lymphoma

Summary: the purpose of this study is to compare different estimates of calculating creatinine clearance by mathematical formula and compare them to creatinine clearance based on a timed urine collection in patients who received high-dose methotrexate for the treatment of primary cns lymphoma or cns involvement of systemic lymphoma.

we intend to perform a retrospective chart review to identify a serum creatinine-based equation that gives the best estimate of crcl as compared with an equation derived from a 24-hour urine collection. study subjects will be identified using the brigham and women's hospital and dana-farber cancer institute's adult pharmacy systems to identify patients who received high-dose methotrexate. data will be collected starting with december 31, 2010 and proceeding chronologically backwards until the target enrollment of 40 patients is reached.

Eligibility criteria:
inclusion criteria: * age \>/= 18 years * received high-dose methotrexate therapy at dana-farber cancer institute/brigham and women's hospital for the treatment of primary cns lymphoma or cns involvement of systemic lymphoma * available timed urine collection within 1 week of hdmtx exclusion criteria: * receiving high-dose methotrexate for indications other than primary cns lymphoma or cns involvement of systemic lymphoma * documented viral hepatitis
costoclavicular vs paracoracoid approach to infraclavicular brachial plexus block: a feasibility study

Conditions: Upper Limb Injury

Summary: patients for upper limb surgeries who are candidates for infraclavicular block will be screened. two techniques of infraclavicular block will be compared. measured outcomes are performance times, block onset times, patient satisfaction, quality of block, and requirement for supplementary analgesia.

infraclavicular brachial plexus block under ultrasound guidance is used for surgeries on the upper limb. traditionally, the block is performed at the lateral infraclavicular fossa where the cords are variable in position relative to the axillary artery. a recently introduced technique is the costoclavicular approach where the cords are viewed as relatively more superficial and clustered together compared to the traditional technique. those meeting the inclusion criteria and will consent to participate in the study will be randomized to have either an infraclavicular block in the paracoracoid approach (group 1) or an infraclavicular block in the costoclavicular approach (group 2). all groups will have the same injectable volume (35 mls) and local anesthetic concentration (ropivacaine 0.5%). there will be 35 study patients for each group for a total of 70 patients.

Eligibility criteria:
inclusion criteria: * ambulatory elective surgery of the upper limb * asa (american society of anesthesiologists physical status classification system) 1-4 * suitable for procedure to be carried out under infraclavicular block exclusion criteria: * inability to give informed consent, allergy to local anesthetics, morphine or fentanyl * ongoing major medical or psychiatric problems * narcotic abuse * peripheral neuropathy or major neurological problems * scarring in area of blockade * inability to co-operate with post-operative evaluation * major coagulopathy * pregnancy and breast-feeding * women of childbearing age who are not taking adequate contraceptive precautions
mhealth intervention to support diabetes medication adherence (pilot study)

Conditions: Diabetes Mellitus, Type 2

Summary: this study aims at evaluating the feasibility of an intervention based on the use of a mobile-device based system delivering automated, tailored brief text messages to offer support for medicine use and lifestyle recommendations alongside usual care to people with type 2 diabetes.

a list of patients registered in primary care centers of the balearic islands and potentially meeting the eligibility criteria will be obtained from electronic health records (ehrs). a research assistant will contact the potential participants via phone to invite them to the study and confirm eligibility. all eligible participants will complete informed consent followed by baseline assessment over the phone before randomization. participants will be randomly allocated using a computer-generated randomization sequence. all participants will continue with their usual diabetes care including all medical visits, tests, and diabetes support programs throughout the study. in addition, the intervention group will receive the text messaging intervention. control participants will receive usual care only. after three months of follow-up, all participants will complete post-intervention assessments via phone interview. data on glycemic control (hba1c) at baseline and post-intervention will be extracted from ehrs, as according to the protocol used for primary care providers in the balearic islands, patients with poor glycemic control (hba1c \>8% ) must request an hba1c determination every six months. results of the most recent determination will be extracted from electronic medical records. for those patients with no recorded hba1c within the previous three months, the research assistant will contact the primary care center and the patient to arrange blood test analyses.

Eligibility criteria:
inclusion criteria: * patients registered in the public health service of the balearic islands * with type 2 diabetes * at least one prescription of an oral glucose-lowering drug * with results of hba1c\>8% from 3 months prior to recruitment. exclusion criteria: * younger than 18 years old * with insulin treatment.

Keywords: diabetes medication adherence glycaemic control healthy lifestyle mhealth sms
hexvix photodynamic therapy in patients with bladder cancer

Conditions: Intermediate or High-risk Bladder Cancer

Summary: the purpose of the study is to investigate the safety and feasibility of hexaminolevulinate based photodynamic therapy in patients with intermediate or high-risk transitional cell carcinoma of the bladder.

non-muscle invasive bladder cancer is currently treated by transurethral resection (turb) and/or fulguration. however, recurrence and progression rates following endoscopic treatment of visible lesions are significant. to prevent recurrent and progressive disease, adjuvant intravesical chemotherapy and immunotherapy are applied. there is also increasing interest in new therapeutic strategies such as photodynamic therapy.

Eligibility criteria:
inclusion criteria: * male or female aged 18 years or above who have given written informed consent. * patients with intermediate or high-risk superficial bladder cancer, defined as low-grade early recurrence within 6 months after local chemotherapy or bcg, primary or recurrent high-grade disease (tag3, tag3 with cis or cis alone) or patients with primary t1g3 who are tumour free at second resection. exclusion criteria: * patients with muscle invasive tumour * patients with bladder shrinkage * patients who have received prior pdt for bladder cancer * history of t1g3 disease or other indications for cystectomy * patient with porphyria * gross haematuria. (note: gross haematuria is defined as a heavy bladder bleed resulting in marked amounts of blood in the urine, which may interfere with pdt) * patients who have received bcg or chemotherapy within three months prior to hexvix instillation, except for a single dose of chemotherapy for prevention of seeding after resection * known allergy to hexaminolevulinate or a similar compound * participation in other clinical studies either concurrently or within the last 30 days * women of child-bearing potential. * conditions associated with a risk of poor protocol compliance
effects of black soy peptide supplementation on blood pressure

Conditions: Hypertension

Summary: black soy peptides have been shown to possess properties that may decrease blood pressure. to examine the effects of black soy peptides supplementation on blood pressure and oxidative stress in subjects with pre-hypertension or stage i hypertension.

trial participants included men and women aged 30 to 65 years who had an average systolic blood pressure (sbp) between 130 to 159 mmhg, average diastolic blood pressure (dbp) between 80 to 99 mmhg, or both, based on an average of six measurements during two screening visits. participants were supplied with 84 pouches of placebo (casein) or black soy peptide (3 pouches/day) at 0-week and at 4-week visits. test group subjects received pouches containing black soy peptides (4.5 g/day total soy peptides for 8 weeks). the control group received pouches containing casein that had a similar appearance to the black soy peptide tablet. during the intervention, we instructed study participants to continue their current food intake patterns and lifestyles so that total energy intake and energy expenditure would be constant during the course of trial. participants brought back unconsumed pouches at their 4- and 8-week follow-up visits. the dietitian counted the number of returned pouches, and we used this to assess the participants' adherence to their assigned intervention.

Eligibility criteria:
inclusion criteria: * average systolic blood pressure (sbp) between 130 to 159 mmhg * average diastolic blood pressure (dbp) between 80 to 99 mmhg, or both, based on an average of six measurements during two screening visits exclusion criteria: * previous diagnosed clinical hypertension * self-reported use of anti-hypertensive medication * abnormal liver or renal function * history of cardiovascular disease, cancer, thyroid or pituitary disease, or any other serious life-threatening illness that required regular medical treatment
a real-time ultrasound guided approach for spinal anesthesia

Conditions: Patients Aged 55 or Older; BMI More Than 40 kg/m2; Scoliosis

Summary: our goal was to compare the number of attempts to perform spinal anesthesia using real-time ultrasound guidance versus landmark technique in patients meeting predefined criteria for difficult spinal anesthesia.

patients who consent to receive spinal anesthesia (as opposed to some other anesthetic technique) and who meet the inclusion/exclusion criteria for the study (given below) will be randomized on day of surgery after obtaining informed consent to either ultrasound-guided or standard spinal anesthesia technique. a block randomization scheme with random block sizes ranging from 2-8 patients will be used. the outcomes will be recorded by a third party observer in the block room/operating room who might be a nurse or resident or clinical research fellow not directly involved with performing the block. the post procedure outcomes will also be recorded by a clinical research fellow or resident who was not directly involved with performing the block. no sample size estimation methodology currently exists for the right-censored count data models. we expect less number of attempts in the ultrasound group a 20 % difference between the two groups which we feel is a minimum of a clinically-relevant effect. at the 0.05 level of significance with a power of 0.8, we will require a minimum of 20 patients per group,therefore we plan to recruit 40 patients in total. the analysis will be conducted by a statistician who will be blinded.

Eligibility criteria:
inclusion criteria: 1. patients aged 55 or older 2. bmi more than 40 3. scoliosis exclusion criterion: 1 patients who have undergone previous spine surgery
detection of biomarkers in abnormal cervical cells in women with abnormal pap test results

Conditions: Cervical Cancer

Summary: rationale: examining biomarkers in abnormal cervical cells may improve the ability to detect these cells and plan effective treatment. purpose: diagnostic trial to detect specific biomarkers in abnormal cervical cells in women who have abnormal pap test results.

objectives: i. compare the detection of transferrin receptor, epidermal growth factor receptor, and the matu-mn protein in exfoliated cervical epithelial cells from women with abnormal pap test using fluorescent labeled antibody probe vs histology. outline: patients undergo a pap test and a colposcopy. cervical epithelial cells are collected from the most abnormal appearing lesion. cells are examined for molecular markers using a fluorescent antibody test. the presence or absence of these markers is compared to results of the pap test and the histology of the cells. projected accrual: a total of 100 patients will be accrued for this study within 6 months.

Eligibility criteria:
disease characteristics: diagnosis of abnormal pap test, as indicated by one of the following: atypical squamous cells of undetermined significance (ascus) low grade squamous intraepithelial lesion (lgsil) high grade squamous intraepithelial lesion (hgsil) visible lesion on cervix by colposcopy patient characteristics: age: any age performance status: ecog 0-4 life expectancy: not specified hematopoietic: not specified hepatic: not specified renal: not specified other: pregnant or nursing women allowed prior concurrent therapy: biologic therapy: not specified chemotherapy: not specified endocrine therapy: not specified radiotherapy: no prior pelvic irradiation surgery: no prior total hysterectomy

Keywords: cervical cancer
topic compatibility dermacyd delicata - new fragrance - lactoserum - hygiene

Conditions: Hygiene

Summary: the purpose of this study is to demonstrate the absence of potential irritation (primary dermic irritability and cumulated dermic irritability) and allergy (sensibilization) of the product dermacyd delicata (new fragrance of dermacyd)


Eligibility criteria:
inclusion criteria: * phototype skin i,ii, iii and iv * integral skin test in the region; exclusion criteria: * lactation or gestation * use of antiinflammatory and/or immunosuppression drugs * personal history of atopy; * history of sensibilization or irritation for topic products; * active cutaneous disease; * use of new drugs or cosmetics during the study