Kornimate/medical-research-clean huggingface dataset:
sad study of apr002 investigating the safety/tolerability, pharmacokinetics/pharmacodynamics in healthy subjects

Conditions: COVID-19

Summary: this study will investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending doses of apr002 in healthy subjects.

a phase 1, randomized, blinded, placebo-controlled, first-in-human, single ascending dose study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of apr002 administered by inhalation in healthy volunteers

Eligibility criteria:
inclusion criteria: * healthy men or women aged 18 to 55 years (inclusive) with suitable veins for cannulation or repeated venipuncture. * women can be of childbearing potential and must have been stable on a highly effective contraceptive method for at least 3 months prior to visit 1 (screening) and be willing to continue on the chosen contraceptive method * male subjects should be willing to use a condom (with spermicide) to prevent pregnancy and drug exposure of a female partner and refrain from donating sperm or fathering a child from the day of the investigational product administration until 3 months * have a body mass index (bmi) between 18 and 32 kg/m2 and weigh at least 45 kg. exclusion criteria: * history or presence of clinically significant medical (e.g., chronic obstructive pulmonary disease, asthma, covid-19, etc.) or psychiatric condition or disease * abnormal vital signs, after minutes rest, defined as any of the following (sbp \> 140 mmhg, diastolic blood pressure (dbp) \> 90 mmhg, heart rate \ 99 beats per minute) * prolonged qtcf \> 450 ms or family history of long qt syndrome
anti-cd22 car-t cell therapy targeting b cell malignancies

Conditions: Leukemia; Lymphoma

Summary: the study will evaluate safety and efficacy of the cd22-targeted chimeric antigen receptor modified-t cell(car-t) cells in the treatment of b-cell malignancies.

clinical success with chimeric antigen receptor (car)- based immunotherapy for leukemia has been accompanied by the associated finding that antigen-escape variants of the disease are responsible for relapse. despite anti-cd19 car-t exhibited the ability to re-induce remissions for many patients with relapsed and refractory b cell malignancies, a part of those patients will relapse with cd19-negative malignancies. cd22 is a type i transmembrane protein expressed on most mature b lymphocyte in the b cell malignancies，and plays a significant role in signal transduction pathway. the investigators design and conduct this trial to test the safety and effectiveness of cd22-targeted car-t.

Eligibility criteria:
inclusion criteria: 1. age: 18-65 years 2. patients with cluster of differentiation 22(cd22) positive b cell malignancies as confirmed by flow cytometry 3. refractory or relapsed b cell-acute lymphoblastic leukemia 4. no available curative treatment options (such as hematopoietic stem cell transplantation) 5. stage iii-iv disease 6. creatinine \< 2.5 mg/dl 7. aspartate transaminase-alanine transaminase ratio \< 3x normal 8. bilirubin \< 2.0 mg/dl 9. karnofsky performance status \>= 60 10. expected survival time \> 3 months 11. adequate venous access for apheresis 12. ability to understand and provide informed consent exclusion criteria: 1. pregnant or lactating women 2. patients requiring t cell immunosuppressive therapy 3. active central nervous system leukemia 4. any concurrent active malignancies 5. patients with a history of a seizure disorder or cardiac disorder 6. previous treatment with any immunotherapy products 7. patients with human immunodeficiency virus, hepatitis b or c infection 8. uncontrolled active infection

Keywords: cd22 car-t leukemia lymphoma
toric intraocular lens (iol) implantation for management of cataracts

Conditions: Toric Intraocular Lens Stability; Visual Quality

Summary: this study included cataract patients who underwent toric intraocular lens (iol) implantation, which aimed to evaluate the stability and clinical visual quality of toric iols.

this study included cataract patients who underwent the implantation of toric intraocular lens (iol) with haptic design, which aimed to evaluate the stability and clinical visual quality of toric iols.

Eligibility criteria:
inclusion criteria: * cataract exclusion criteria: * • small pupil * zonular dehiscence * preexisting corneal pathology * glaucoma * uveitis * a history of ocular trauma or surgery * severe intraoperative and postoperative complications
pharmacokinetics of the tablet formulation of lopinavir/r as standard and increased dosage during pregnancy

Conditions: HIV Infections; Pregnancy

Summary: this is a multicenter, open, prospective and randomized study aimed at evaluating the pharmacokinetics of the tablet formulation of lopinavir/r administered in combination with two nucleoside analogs to hiv-infected pregnant women at two different dosages: * group 1 (standard dosage): 200/50 mg lopinavir/r, 2 tablets every 12 hours, plus two nucleoside analogs. * group 2 (increased dosage): 200/50 mg lopinavir/r, 2 tablets every 12 hours until the end of the second trimester of gestation (24 weeks) and 3 tablets every 12 hours in the third trimester (from 25 weeks on), plus two nucleoside analogs. treatment will be initiated at any time between 14 and 30 weeks of gestation and will be maintained for at least 6 weeks after delivery. the objectives are: * to compare the pharmacokinetic parameters of the standard and increased dosage of the tablet formulation of lopinavir/r during pregnancy. * to determine whether the standard and/or increased dosage of the tablet formulation of lopinavir/r during pregnancy confers the same exposure to the drug as that observed in the same women after the end of pregnancy and in historic controls. * to evaluate the transplacental passage of lopinavir/r based on the ratio between the serum concentration in maternal blood at the time of delivery and in cord blood of the two drug dosages (standard and increased) administered during pregnancy. * to evaluate the tolerability of the two lopinavir/r dosages (standard and increased) during pregnancy. * to describe the vertical transmission rate of hiv to the children of the pregnant women included in the study.


Eligibility criteria:
inclusion criteria: * capacity to consent and wish to participate in the study, documented by signing the specific informed consent form (icf) of the study. * age of 18 years or older. * pregnancy documented by urine or blood examination or ultrasound. * gestational age of 14 to 30 weeks calculated by ultrasound, obstetric examination or date of last menstruation, depending on what is considered to be more exact by the medical investigator. * hiv infection documented by two serological tests using different methods or analysis of hiv viral load with a positive result. * no use of antiretroviral drugs at the time of diagnosis of pregnancy (previous prophylaxis and treatment are allowed). * intention to continue the treatment of the study for at least 6 weeks after delivery. exclusion criteria: * history of hypersensitivity to lopinavir or ritonavir. * need for the concomitant use of contraindicated drugs in combination with lopinavir/ritonavir. * any condition that, in the opinion of the medical researchers, impairs the participation in and fulfillment of the procedures of the study.

Keywords: hiv pregnancy vertical disease transmission pharmacokinetics hiv seronegativity
lanreotide autogel in patients with acromegaly previously treated with octreotide lar

Conditions: Acromegaly

Summary: the purpose of this study is to assess the efficacy, safety and patient acceptability of somatuline autogel in patients with acromegaly previously treated with octreotide lar.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of acromegaly * the patient must have been tested at week -4 (4 weeks prior to the baseline visit) and shown to have a gh level \<10 mu/l. * the patient must have been treated with a stable dose of octreotide lar for at least four months prior to study entry * life expectancy of at least 2 years exclusion criteria: * adenectomy within past 6 months, or likely during study period * radiotherapy for acromegalic disease within 1 year, or likely during study period * unstable concomitant dopamine agonist therapy

Keywords: acromegaly growth hormone
domestic surgical robot clinical study

Conditions: Gastric Ulcer With Perforation But Without Obstruction; Colon Cancer; Cholecystolithiasis; Appendicitis; Sleeve Gastrectomy; Gastric Bypass; Gastric Cancer; Rectal Cancer

Summary: central south university in collaboration with tianjin university developed the first domestically produced chinese minimally invasive surgical (mis) robot system which named "micro hand s" in 2013. recently, as the domestic surgical robot research project's main section, this new mis robot had been authorized to enter the clinical trial stage by the ethics committee of the third xiangya hospital at central south university.

one surgeon perform these surgical trials using the robot "micro hand s". all of the patients were followed for 12 months, and pre- and postoperative changes in blood route test and hepatorenal function examination, surgery duration, hospital stay, total robotic setup time, total robotic operation time, intraoperative blood loss, total postoperative drainage amount, duration of bearing drainage tubes were recorded. in addition, the pre- and postoperative changes in the pathological and functional outcomes were measured.

Eligibility criteria:
inclusion criteria: * diagnosis of gastric tumor, colorectal tumor, acute cholecystitis and ileocecal tumor respectively * 18years\<age\<65years * male or female exclusion criteria: * patients with a history of open abdominal surgery * unstable psychiatric illness * an inability or reluctance to cooperate during long-term follow-up * alcohol or drug addiction * or relatively high surgical risks, such as abnormal coagulation function or bad heart, lung, liver and kidney function, were excluded from this study
correlation salivary cortisol and free serum cortisol to total serum cortisol in micu septic shock

Conditions: Septic Shock

Summary: the purpose of the study is: * to correlate salivary cortisol to free serum cortisol (as salivary cortisol is considered to be almost complete free cortisol) and, * to correlate free serum cortisol to total serum cortisol levels both in patients with septic shock (severe sepsis requiring vasopressors). we believe that: * total serum cortisol does not correlate with free serum cortisol in patient with septic shock and, * that salivary cortisol correlates with free serum cortisol and can be used to determine the level of free serum cortisol.

free serum cortisol is considered the active hormone. in patients with septic shock only the total serum cortisol level is available, however, the free cortisol level can be normal despite a low total cortisol level due to changes in the serum protein. the hormone can be replaced improperly in these patients and contribute to poor outcome in septic shock. we are studying adult micu patients with septic shock who are not receiving corticosteroid replacement. this study does not include any intervention. in-hospital or 28-day mortality are registered in all the patients.

Eligibility criteria:
inclusion criteria: * adult patients with septic shock exclusion criteria: * corticosteroid replacement * blood in mouth

Keywords: cortisol
flow-restorative yoga to decrease pain and inflammation

Conditions: Pain; Inflammation

Summary: the restorative flow yoga study is a pilot project looking at whether restorative flow yoga will reduce inflammation and pain in women 60 and older who experience chronic pain.

the aims of the study are to (1) evaluate the feasibility of implementing a restorative-flow yoga randomized trial (24 classes, held twice per week) for women aged 60 or older who experience chronic pain; and (2) evaluate the preliminary efficacy of restorative-flow yoga to decrease pain and inflammation among women aged 60 or older. feasibility measures will include three areas of focus (a) acceptability, (b) implementation, and (c) demand and use, evaluated using recruitment rate, retention rate, class and home practice adherence rates, resource utilization, and safety. with a sample size of 40, this pilot feasibility study is likely under-powered to determine intervention effects. however, the study will evaluate preliminary efficacy of the yoga intervention. the study will measure bmi, blood pressure, resting heart rate, physical function measures, and inflammatory markers c-reactive protein, il-2, il-1β, tnf-α, il-6, il-4, and il-10) at baseline and outcome assessments (after 24 class sequence).

Eligibility criteria:
inclusion criteria: * female * age 60 or older * report average severity of 3 or higher on the brief pain inventory * blood pressure is less than 160/100 mm hg * heart rate is between 55-110 bpm * able and willing to obtain physician's approval to participate exclusion criteria: * currently practicing yoga two or more times per week * cognitively impaired
clinical effect of neoadjuvant hierarchical treatment based on chemotherapy

Conditions: Rectum Cancer

Summary: clinical effect of neoadjuvant hierarchical treatment based on chemotherapy for t3-4n0-2m0 middle and lower rectal cancer

by setting 3-year disease-free survival (dfs) as main objective, the treatment strategy will be optimizing as neoadjuvant chemotherapy alone and chemo-radio-chemo sequential treatment.

Eligibility criteria:
* inclusion criteria * pathologically confirmed to be rectal adenocarcinoma. * distance \< 10cm from the end of the tumor to the anal verge found on colonoscopy * tumor in stage t3-4n0-2 (pelvic mri evaluation) * patients without distant metastases (such as liver and peritoneum, lungs, aortic lymph nodes) * patients with karnofsky score greater ≥ 70 * wbc \> 3.5 x 109/ml , plt \> 10 x 109/ml , tbil\ 50ml/min (evaluated using the cockcroft-gault formula: creatinine clearance (male) = {(140 - age) x lbm (kg)} / {plasma creatinine (mg/dl) x 72} ; creatinine clearance (female) = 0.85 x {(140 - age) x lbm(kg)}/ { plasma creatinine (mg/dl) x 72}) * patients must sign the informed consent form * female subjects must be contraceptive during the trial * patients who did not receive any form of chemotherapy and radiotherapy * no other important related diseases (such as other tumors, severe heart disease and central nervous system diseases, etc.) * age must be equal or more than 20 and must be equal or less than 70 * exclusion criteria * previously received radiation therapy, chemotherapy or anti-tumor biological therapy * previously received immuno-suppressive therapy * participation in interventional clinical trial over the past time * suffering from malignant colonic neoplasms simultaneously * with peripheral neuropathy(above who i level) * affected cognitive abilities because of neurological or psychiatric abnormalities including central nervous system metastasis * medical history of severe allergies or allergic constitution * severe pulmonary or heart disease history * female patients who are in pregnancy or lactation and refuse contraception * previously with other malignant tumors * exit criteria * occurrence of bleeding, obstruction, perforation and other complications * occurrence of distant metastasis during the period of neoadjuvant therapy * adverse reactions, not be tolerated and do not want to continue to receive treatment * patients voluntarily quit * capecitabine-related grade 4 hand-foot syndrome

Keywords: neoadjuvant chemotherapy
determining the role of social reward learning in social anhedonia

Conditions: Psychosis

Summary: this is a clinical trial study that aims to evaluate the specificity of the relationship between reduced sensitivity to social reward and social anhedonia at both behavioral and neural levels. individuals who recently experienced their first-episode psychosis will be recruited. participants will be randomized 1:1 to motivational interviewing or a time- and format-matched control probe. at pre- and post-probe, participants will perform two social reward learning tasks in the scanner. with this design feature, we will examine the relationship between sensitivity to social reward and reduced subjective experience of social pleasure at both the behavioral and neural levels.


Eligibility criteria:
inclusion criteria: * age 18-35 years * a first episode of a psychotic illness that began within the past three years * diagnostic and statistical manual of mental disorders (dsm)-5 diagnosis of schizophrenia, schizophreniform, or schizoaffective disorder * taking 2nd generation antipsychotic medications * estimated premorbid iq not less than 70 as assessed with the wechsler test of adult reading * appropriate for scanning (i.e., no pacemaker or metal implants) and expressed willingness to participate in scanning * sufficient fluency in english to comprehend testing procedures * corrected vision of at least 20/30 exclusion criteria: * no evidence that substance use makes the diagnosis ambiguous (rule out substance-induced psychosis) * no evidence of moderate or severe alcohol or substance use disorder in the past 3 months * no clinically significant disease based on medical history (e.g., epilepsy) or significant head injury * for females: no current pregnancy * no sedatives or anxiolytics on the day of assessment * no medication change 3 weeks prior to enrollment

Keywords: social anhedonia, social reward learning, fmri, sensitivity to reward
uncemented hemiarthroplasty, radiological features comparing lateral versus anterolateral approach

Conditions: Femoral Neck Fractures; Hemiarthroplasty; Heterotopic Ossification

Summary: uncemented hemiarthroplasty, radiological features comparing lateral versus anterolateral approach. comparing leg length discrepancy, femoral offset, valgus/varus position of the stem. also is there a difference in heterotopic ossification at 12 months.

between january 2014 and july 2017 a rct was conducted at sorlandet hospital kristiansand, norway. the trial was approved by the regional ethics committee (2013/1853/rek) and registered at clinicaltrials.gov (clinicaltrials.gov identifier nct02028468). this study is a follow-up on the same study population. 150 patients (70 to 90 years) with a displaced femoral neck fracture was randomized to be operated with either anterolateral og direct lateral surgical approach. investigators want to compare the radiological features of the femoral stem between the two groups.

Eligibility criteria:
inclusion criteria: * patients between 70 and 90 years of age with displaced femoral neck fractures * intact cognitive function * ability to walk with or without a walking aid prior to falling. exclusion criteria: * dementia * fractures in pathologic bone * patients not belonging to the hospital community * patients with sepsis or local infection * fracture not eligible to be treated with a hemiarthroplasty

Keywords: femoral offset leg length discrepancy valgus/varus position lateral approach anterolateral approach
the effects of l-arabinose and d-xylose on intestinal sucrase activity in man

Conditions: Insulin Resistance

Summary: the purpose of this study is to investigate the effect of l-arabinose and d-xylose in a sugar-rich drink on intestinal sucrase activity in healthy volunteers by measuring postprandial blood glucose and insulin, and selected intestinal hormonal responses to increasing doses of l-arabinose and d-xylose.

based on previous scientific results we hypotesize, that pentoses decreases the demand for insulin in metabolizing a given dose of sucrose.

Eligibility criteria:
inclusion criteria: * healthy males * bmi between 18.4-25 kg/m2 * age between 18 and 30 exclusion criteria: * donation of blood 3 months before or during the study * gastrointestinal disorders, diabetes, hypertension, hyperlipidemia, chronic infectious disease (hiv or hepatitis) * smoking * consumption of more than 21 alcoholic drinks/week * elite athletes * on medication

Keywords: l-arabinose d-xylose sucrose glucose insulin c-peptide glp-1
new pharmacological treatment for obstructive sleep apnea

Conditions: Obstructive Sleep Apnea

Summary: this study will determine if mirtazapine, a unique antidepressant that does not disturb sleep, will improve obstructive sleep apnea (osa). the design is randomized, crossover, double blind, and placebo controlled. on two consecutive nights of one week, the patients receive either 30 mg mirtazapine or placebo at bedtime. the following week, the alternative medication is administered. the patients have known mild to moderate sleep apnea. the endpoints of the study are the apnea + hypopnea index (ahi), sleep quality, and the degree of arterial oxygen desaturation.


Eligibility criteria:
inclusion criteria: * known osa mild to moderate exclusion criteria: * on antidepressant or antipsychotic medications

Keywords: sleep apnea mirtazapine sleep
allopurinol in acute gout

Conditions: Gout

Summary: the objectives of the present study are to determine if starting treatement of hyperuricemia with allopurinol during an acute gout crises has an impact on the duration or the severity of the crises


Eligibility criteria:
inclusion criteria: more than 18 years old able to sign informed consent indication of long-term treatment with allopurinol acute gout crisis exclusion criteria: les than 18 years-old unable to consent contra-indication to allopurinol

Keywords: gout uric acid allopurinol
high ankle block versus regional block for acute pain control after ankle surgery

Conditions: Ankle Surgery

Summary: researchers are trying to determine if a high ankle block during ankle surgery provides the same pain relief as the standard regional block.

participants scheduled for elective ankle surgery will be randomized to have either a high ankle nerve block or a regional nerve block. pain levels after surgery will be assessed to determine whether one type of block provides better pain relief compared to the other.

Eligibility criteria:
inclusion criteria * adults undergoing elective foot and ankle surgery * adults ≥18 years, intact presurgical peripheral sensation based on 5.07 monofilament testing, foot and ankle surgery exclusion criteria * presurgical neurologic discrepancies (peripheral neuropathy, radiculopathy) * complex regional pain syndrome * peripheral nerve surgery * surgery above the level of the tibiotalar joint * narcotic dependency * anyone unable to receive a high ankle block

Keywords: nerve block