Kornimate/medical-research-clean huggingface dataset:
microvascular and cardiac dysfunction in paroxysmal nocturnal hemoglobinuria and sickle cell disease

Conditions: Rheologic Disease; Sickle Cell Disease; Paroxysmal Nocturnal Hemoglobinuria

Summary: the purpose of this study is to examine how abnormal blood flow in the small vessels (microvessels) of the heart, muscle and kidney in paroxysmal nocturnal hemoglobinuria (pnh) or sickle cell disease leads to poor functioning of the heart and kidney. to test this question, the investigators will perform imaging tests (contrast ultrasound perfusion imaging) to look at the flow and function of these microvessels and compare this information to heart and kidney function. to further look at this question, patients who have pnh will be studied before and after starting a new drug (soliris) that decreases damage to blood cells. in patients with sickle cell disease, patients will be studied at baseline (not during a pain crisis) and also during a pain crisis if one develops.


Eligibility criteria:
inclusion criteria: * established diagnosis of pnh or scd age \> 18 years old exclusion criteria: * pregnant or lactating women presence of significant right to left shunting allergy to ultrasound contrast agent reactive airways disease significant peripheral or coronary artery disease

Keywords: rheology sickle cell paroxysmal nocturnal hemoglobinuria contrast ultrasound
feasibility study of renal denervation for the treatment of resistant hypertension

Conditions: Uncontrolled Hypertension

Summary: the aim of this study is to assess the potential therapeutic benefit of catheter-based renal sympathetic denervation using therapeutic unfocussed ultrasound in a single-arm feasibility trial.


Eligibility criteria:
inclusion criteria: * uncontrolled hypertension (defined as sbp ≥ 140 mmhg during 24hr ambulatory bp monitoring) * current treatment with ≥ 3 anti-hypertensive drugs (including at least one diuretic) * renal artery diameter ≥5mm by digital angiography * accessibility of renal vasculature exclusion criteria: * estimated gfr \< 45 * type 1 diabetes * known renovascular abnormalities (eg, renal artery stenosis, previous renal artery stenting or angioplasty)

Keywords: hypertension uncontrolled hypertension resistant hypertension
study of glucarpidase (cpg2) for the management of patients with delayed methotrexate clearance

Conditions: Neoplasms

Summary: to evaluate the safety and efficacy of glucarpidase in patients with impaired methotrexate (mtx) clearance owing to mtx-induced renal failure following high-dose mtx therapy, or with intrathecal mtx overdose.


Eligibility criteria:
inclusion criteria: * written informed consent by patient or legally valid representative * patients receiving high-dose mtx (\>1 g/m2 body surface area (bsa) given as an infusion over 24 hours) for the treatment of all, nhl or a solid tumour (e.g. osteosarcoma) * age ≥ 18 years * serum mtx \>5 µmol/l 42 hours or later after the start of mtx infusion, or serum mtx \>1 μmol/l 42 hours or later after the start of mtx infusion together with renal insufficiency, or serum mtx \>0.4 µmol/l 48 hours or later after the start of mtx infusion together with renal insufficiency. renal insufficiency was defined as serum creatinine \>1.5 × the upper limit of normal (uln) and/or oliguria (urine output \< 500 ml/24 hours despite adequate hydration, diuretics and alkalinisation). exclusion criteria: * pregnant or lactating females * unwillingness of patient or relative/legal representative to give informed consent

Keywords: methotrexate delayed elimination renal insufficiency cpg2 voraxaze
topical loperamide gel for pain reduction during repeat finger lancing

Conditions: Pain

Summary: this study evaluates topical loperamide 5% gel in reducing pain during repeat finger lancing (finger stick) in healthy adults. half of participants received 5% loperamide gel applied to their fingertip prior to their second lance and the other half received the gel only.

lancing the finger and heel to obtain capillary blood for specimen collection and diagnostic testing is a painful and tissue damaging procedure. with each lance, there is direct splicing of capillaries along with free nerve endings resulting in an immediate localized pain response and hyperalgesia from the release of pain producing substances. opioid agonists (morphine, fentanyl, loperamide) have demonstrated significant analgesia when locally injected or topically applied to a site of inflammation/injury in animal models. loperamide, a piperdine derivative with a structure similar to the synthetic opioid meperidine, has strong affinity for mu opioid receptors. it was approved by the fda in 1969 as an anti-diarrheal agent with mu opioid activity mimicked the constipating effects of other opioids, but with markedly reduced cns effects due to its affinity for p-glycoprotein, preventing crossing the blood brain barrier (bbb) under normal circumstances. this prospective, double-blind, repeated measures, randomized investigational new drug trial used loperamide developed as a topical gel in 34 adult participants to determine its analgesic effects during repeat finger lancing. the investigators also assessed for any local skin reaction to the gel application and for any constipation or abdominal cramping which might be evidence of systemic absorption and mu opioid agonist activity on the gut. this study would be applicable for use in 28.9 million adults who are diabetic and require finger lancing for blood glucose monitoring and the high risk newborn population who require repeat heel lancing for specimen collection.

Eligibility criteria:
inclusion criteria: * healthy volunteers willing to have 2 consecutive finger sticks completed. exclusion criteria: * participants are excluded if they have a history of drug induced hypersensitivity reactions; took any anti-inflammatory medications in the past 12 hours; if they routinely performed finger lancing for blood specimen monitoring (e.g. diabetes); or had calloused fingers pads.

Keywords: fingerstick opioid heelstick loperamide topical opioid
ramelteon and citicoline for delirium

Conditions: Delirium

Summary: primary aim of this study is to assess the feasibility of conducting clinical research for delirium (confusion due to medical problems) at clements university hospital in dallas, texas. a secondary aim is to assess whether an fda-approved sleeping aid called ramelteon or an over-the-counter supplement called citicoline are safe and beneficial in delirium.

this will be a 5-day, non-randomized, open-label, consecutive case series of ramelteon treatment followed by a separate consecutive case series of citicoline treatment, both running in parallel with a non-randomized, observation-only, treatment as usual arm in hospitalized patients with delirium. on the drug treatment arm, first five consecutive subjects meeting diagnostic and statistical manual (dsm)-5 criteria for delirium will be given ramelteon 8 mg daily at bedtime for 5 days. the next five consecutive patients will be given citicoline 250 mg daily at bedtime for 2 days, followed by 500 mg daily at bedtime for 3 days. patients on the observation-only arm will be screened and followed similarly, except they will not be given any experimental drugs. all subjects will continue to receive standard medical care for delirium, including optimal medical treatment, psychotropic medications and consultations with specialty services as necessary. the study is a small pilot to see if there is good feasibility, tolerability and a signal for delirium improvement efficacy with the two medications. the goal is to develop the ability to conduct delirium research at this institution and obtain some preliminary pilot data. these data will be used to design and obtain funding for future, larger research studies. the data from each medication will be examined to look for patterns suggesting that one may be preferable for further research. however, given the very small sample size, meaningful between-group statistical analyses are not possible.

Eligibility criteria:
inclusion criteria: * admitted to inpatient units commonly known as 12-south or 12-north at clements university hospital * has capacity to give informed consent or legally authorized representative is available at bedside * expected duration of hospitalization longer than 48 hours * fluent in english * can be screened by study physician within 24 hours of admission exclusion criteria: * history of angioedema or any other allergic reaction with previous ramelteon therapy * pregnant or currently breast-feeding * concurrent use of fluvoxamine * severe hepatic impairment * severe obstructive sleep apnea

Keywords: citicoline, ramelteon, rozerem
a comparative study of the effect of epidural dexmedetomidine versus fentanyl added to ropivacaine in pediatric orthopedic surgery

Conditions: Congenital Skelectal Anomaly

Summary: the purpose of this study is to evaluate the effect of epidural dexmedetomidine added to ropivacaine in pediatric orthopedic surgery


Eligibility criteria:
inclusion criteria: * pediatric patients aged from 3 to 12 years undergoing orthopedic mechanical correction surgery exclusion criteria: * coagulopathy, refusal (parents), current infection on the lumbar area, spinal tract pathology
study to determine safety, pharmacokinetics and efficacy of gmi-1271 in combination with chemotherapy in aml

Conditions: Leukemia, Myeloid, Acute

Summary: this study will evaluate gmi-1271, a specific e-selectin antagonist, in acute myeloid leukemia in combination with standard agents used to treat this disease.


Eligibility criteria:
inclusion criteria: 1. aml (including secondary aml) diagnosed as per who criteria 2. for relapsed/refractory subjects only: * subjects age ≥ 18 years with relapsed or refractory aml after ≤ 2 prior induction regimens, at least one containing anthracyclines * medically eligible to receive mec * absolute blast count (abc) ≤ 40,000/mm 3. for treatment-naïve subjects only: * subjects ≥ 60 years of age with newly diagnosed aml * medically eligible to receive "7+3" cytarabine/idarubicin * abc count ≤ 40,000/mm 4. ecog performance status 0-2 5. hemodynamically stable and adequate organ function exclusion criteria: 1. acute promyelocytic leukemia 2. acute leukemia of ambiguous lineage (biphenotypic leukemia) 3. active signs or symptoms of cns involvement by malignancy 4. no prior g-csf, gm-csf or plerixafor within 14 days of study drug dosing 5. known history or evidence of active hepatitis a, b, or c or hiv 6. uncontrolled acute life threatening bacterial, viral or fungal infection 7. active graft versus host disease (gvhd) ≥ grade 2 or extensive chronic gvhd requiring immunosuppressive therapy 8. hematopoietic stem cell transplantation ≤ 4 months of dosing 9. clinically significant cardiovascular disease

Keywords: aml acute myeloid leukemia e-selectin relapse refractory elderly newly diagnosed induction
triple target treatment (3t) which combines stimulation with amplitude modulated middle frequency (am-mf), electromyography (emg)-triggered stimulation and emg-biofeedback compared with emg-biofeedback in anal incontinence

Conditions: Fecal Incontinence

Summary: the efficacy of biofeedback and/or low frequency electrical stimulation for the treatment of anal incontinence has not been proven. first, large well-designed clinical trials are missing. second, only few patients reach therapeutically relevant intensities with low frequency stimulation. in this study, a novel therapeutic concept, termed triple target treatment (3t) was evaluated. 3t combines stimulation with amplitude modulated middle frequency (am-mf), electromyography (emg)-triggered stimulation and emg-biofeedback. 3t was compared with emg-biofeedback alone after a nine month treatment period. methods in this parallel-group randomised multicenter study with blinded observer we enrolled 158 patients with anal incontinence. primary endpoints were changes from baseline to nine months in the cleveland clinic score (ccs) and the st. mark's score (vaizey score).


Eligibility criteria:
inclusion criteria: * all patients with fecal incontinence i-iii. exclusion criteria: * all patients with cid´s * definite or possible pregnancy

Keywords: exercise therapy biofeedback (psychology) adult fecal incontinence/*therapy emg - biofeedback emg - triggered stimulation augmented biofeedback
efficacy of different nerve stimulation methods in individuals with chronic constipation

Conditions: Constipation

Summary: constipation is the most common digestive complaint in the general population. normal stool frequency ranges from at least three times a week to a maximum of two times a day. constipation can be classified into three main groups as constipation with normal transit time, constipation with slow transit time and dyssynergic defecation disorders.

in chronic constipation, treatment should be directed towards the underlying cause. in the treatment of chronic constipation, lifestyle changes and physiotherapy are in the first place, pharmacological treatment is in the second place, and surgical treatment is in the third place. physiotherapy modalities such as defecation training, classical massage, electrical stimulation, anorectal biofeedback and exercise training can be used in the treatment of chronic constipation.

Eligibility criteria:
inclusion criteria: •being diagnosed with chronic constipation exclusion criteria: * metabolic diseases * severe heart or kidney disease, previous gastrointestinal, spinal or pelvic surgery other than cholecystectomy, hysterectomy or appendectomy, * neurological diseases such as multiple sclerosis, stroke, parkinson's disease or spinal injury, impaired awareness * mini-mental score \< 15 * legal blindness, pregnancy, rectal prolapse, anal fissure, and alternating pattern of constipation and diarrhea.

Keywords: vagus tibial nerve stimülation
hybrid closed loop therapy and verapamil for beta cell preservation in new onset type 1 diabetes (clver): extension study

Conditions: Type1 Diabetes

Summary: the purpose of this extension study is to continue to follow the participants who completed the clver rct for up to 3 additional years. the goal for cohort a is to evaluate the longer-term effects of verapamil on preservation of β-cell function as measured by c-peptide levels obtained during a mixed meal tolerance test (mmtt). for both cohorts a and b, the goal is to determine if the high degree of glycemic control achieved during clver with hcl can be maintained once the intensive engagement of the study team is discontinued. at the completion of the rct, study treatments end. thus, during the extension study, diabetes management is performed as part of usual care and there is no study treatment.

participants who complete the clver rct will be eligible to enroll in the clver extension study. informed consent and assent, when applicable, will be obtained. participants will be contacted every 3 months at which time continuous glucose monitoring (cgm) data will be obtained if a cgm device is being used and medical history (including recent point-of-care or local laboratory hba1c values) will be reviewed; a usual care visit performed by study staff may be considered a study contact. a study visit will occur yearly to update the diabetes and medical history, measure height and weight, determine tanner staging, download cgm data if available, perform an mmtt, and obtain blood samples for central lab measurement of hba1c and plasma for storage if consented. other than the central lab samples, there are no study-specific procedures or data collection that would not be performed as part of standard care.

Eligibility criteria:
completed clver rct 12 month visit and willing to join observational extension.
efficacy, safety and tolerability of telbivudine in hbeag positive chronic hepatitis b pregnant women with elevated alanine aminotransferase levels

Conditions: Chronic Hepatitis B; Pregnancy Complications; High Viral Load; Elevated Alanine Aminotransferase Levels

Summary: telbivudine reduces dna and normalizes alanine aminotransferase levels (alt) in chronic hepatitis b patients with few adverse effects, but its use during pregnancy has not been explored. in this open-label, prospective study from the second trimester to post-partum week 28. this trial is to study the efficacy, safety and tolerability of telbivudine in hbeag positive chronic hepatitis b pregnant women with high level of serum hbv dna and elevated alanine aminotransferase levels.


Eligibility criteria:
inclusion criteria: * age between 20-40 years * gestational age between 12-30 weeks * serum hbsag and hbeag positivity * hbv dna levels \>6log10 copies/ml * alt \>1x uln (40 iu/ml) and \< 10x uln. exclusion criteria: * co-infection with hepatitis a, c, d, e or hiv * evidence of hepatocellular carcinoma; decompensated liver disease or significant renal, cardiovascular, respiratory or neurological co-morbidity * concurrent treatment with immune-modulators, cytotoxic drugs, or steroids * clinical signs of threatened miscarriage in early pregnancy * evidence of fetal deformity by 3-dimensional ultrasound examination * the biological father of the child had chb

Keywords: chronic hepatitis b hepatitis b virus perinatal transmission telbivudine
neuropsychological functioning among children with tourret's disorder and adhd

Conditions: Tourette Disorder; Attention-Deficit/Hyperactivity Disorder

Summary: tourette's disorder (td) is a childhood-onset neuropsychiatric disorder, manifesting motor and vocal tics with increased likelihood of comorbid with attention-deficit/hyperactivity disorder (adhd) and other psychiatric disorders. literature documents the comorbid condition with adhd predicts an increased functional deficit among individuals with adhd. the information about neuropsychological functioning among individuals with td adn/or adhd is little in asian population. this study aims to validate the diagnoses of td, adhd, and td comorbid adhd by symptomatology, neuropsychological measures, and social adjustment. this is a case-control study with a sample of 30 subjects with td, 60 with adhd, 30 with td+adhd, and 60 controls aged from 6 to 18. all subjects will receive comprehensive assessment including standard psychiatric diagnostic interviews using (k-sads-e), behavioral assessments (snap-iv, cprs:r-s, ctrs:r-s, cbcl, ybocs, ygtss), social adjustment (saica, gcas), parenting (pbi, apgar) and neuropsychological assessment (cpt, cantab, wisc-iii). we anticipate that this study will provide the primitive data to validate the td and adhd using neuropsychological and clinical measures.


Eligibility criteria:
inclusion criteria: * patients aged 8-16 without the diagnosis of adhd, and/or tourette's disorder * iq \> 80 * both children/adolescents and their parents consent to participate and have the ability to complete self-administered measures in this study exclusion criteria: * diagnosis of psychotic disorders, bipolar affective disorders, pervasive developmental disorder, seizure, or major physical disorders. * in addition, control subjects will be excluded from the control group if have a history of the following condition as defined by dsm-iv: adhd, odd, or cd in addition to the above exclusion criteria.

Keywords: tourette disorder, adhd, comorbidity, neuropsychological
preoperative ultrasound as a predictor for difficulty in bariatric surgery

Conditions: Obesity, Morbid

Summary: the left lobe of the liver in obese patient usually fatty and enlarged and may cause difficulty during bariatric surgery. the aim of this study is to test the impact of routine preoperative ultrasound to evaluate the size of left lobe of the liver as a preoperative predictor for difficulty

the left lobe of the liver in obese patient usually fatty and enlarged and may cause difficulty during bariatric surgery. the aim of this study is to test the impact of routine preoperative ultrasound to evaluate the size of left lobe of the liver as a preoperative predictor for difficulty. two equal groups of patients are operated by laparoscopic sleeve gastrectomy with loop bipartition, in one group routine abdominal ultrasound is done, in the other group ultrasound not routinely done.

Eligibility criteria:
inclusion criteria: * morbidly obese patient with bmi more than 40 with or without co-morbidity * morbidly obese patient with bmi more than 35 with co-morbidity exclusion criteria: * unfit patients for laparoscopy * patients refuse to share in the study * revisional surgery for obesity * previous upper abdominal surgery
ctc in lung caner patients with bone metastases

Conditions: Lung Cancer; Bone Metastases; Single Cell Sequencing Technology

Summary: 1. evaluate the feasibility of single cell sequencing technology based on three-dimensional bionic capture network; 2. to build a risk prediction model of bone related events based on single cell sequencing; 3. to verify the risk prediction model of bone related events by single cell sequencing; 4. to verify the comprehensive treatment of non-small cell lung cancer ( nsclc) bone metastases.


Eligibility criteria:
inclusion criteria: 1. age 18-75 years 2. pathology-proven diagnosis of lung cancer and radiographical/pathological evidence of bm 3. no previous treatment for bm 4. good general condition (eastern cooperative oncology group, ecog performance scores: 0-2) with an estimated survival time \> 3 months. exclusion criteria: -
safety and efficacy study of tesofensine/metoprolol treatment in subjects with type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus

Summary: safety and efficacy study of tesofensine/metoprolol treatment in subjects with type 2 diabetes mellitus

this is a double-blind, randomized, placebo-controlled, multiple-dose, two-center, safety and efficacy study of co-administration of tesofensine/metoprolol treatment in subjects with t2dm. study medication will be administered for ninety (90) days (+2 days after the final assessments with half-dose of metoprolol). following all baseline assessments, eligible subjects will be randomly assigned to one of the two arms (1:1).

Eligibility criteria:
inclusion criteria: 1. males and females 2. confirmed diagnosis of t2dm 3. 18-70 years of age 4. hba1c ≥7.0% exclusion criteria: 1. hypersensitivity to tesofensine/metoprolol 2. heart failure class ii or greater according to the new york heart association (nyha) or decompensated heart failure 3. history of myocardial infarction or stroke within 12 months prior to enrolment 4. history of coronary revascularisation or angioplasty in the last 12 months prior to enrolment 5. patients reporting angina in the last 6 months prior to enrolment 6. treatment with insulin and/or other injectable anti-diabetic medications, or tzds 7. any clinically significant cardiac arrhythmia
quality of recovery of remimazolam versus sevoflurane in transurethral bladder resection.

Conditions: Quality of Recovery

Summary: this study was designated to investigate the quality of recovery after transurethral bladder resection. because, patients undergoing transurethral bladder resection are mostly old age, and because of catheter-related bladder discomfort are common after transurethral bladder resection, study on the quality of recovery after transurethral bladder resection seems to be meaningful. in general, sevoflurane is commonly used as an anesthetic agent for general anesthesia of transurethral bladder resection. the purpose of this study is to investigate whether remimazolam is not inferior to sevoflurnane in terms of quality of recovery after transurethral bladder resection.


Eligibility criteria:
inclusion criteria: * adult patients aged from 19 years * americaln society of anesthesiologist's class i, ii, and iii * scheduled to undergo elective transurethral bladder resection under general anesthesia exclusion criteria: * refuse to participate in the study * cannot read, or sign the consent form (e.g., iliterate, foreigner, eye disease) * history of allergy to benzodiazepines * decreased liver, kidney, or heart function * pregnant women or breastfeeding patients * history of drug or alcohol abuse * obesity (body mass index \> 30kg/m2)