Kornimate/medical-research-clean huggingface dataset:
isotonic solution administration logistical testing

Conditions: Acute Kidney Injury

Summary: the administration of intravenous crystalloids is ubiquitous in the care of the critically ill. commonly available crystalloid solutions contain a broad spectrum of electrolyte compositions including a range of chloride concentrations. recent studies of associated higher fluid chloride content with acute kidney injury and mortality but no large, randomized trials have been conducted. in preparation for a large, cluster-randomized, multiple-crossover trial comparing 0.9% sodium chloride to physiologically-balanced isotonic crystalloids (lactated ringers or plasmalyte-a) in intensive care unit patients, this pilot study will enroll all patients admitted to the medical intensive care unit at a single tertiary center for a sixth month period. the primary objective will be to test the ability of an electronic order entry tool to ensure administration of assigned study fluid or record contraindications to assigned study fluid. the pilot study will also demonstrate the feasibility of collecting demographic, severity of illness, fluid management, vital sign, laboratory, acute kidney injury and renal replacement therapy, and outcome data in an automated, electronic fashion.


Eligibility criteria:
inclusion criteria: * admitted to the adult medical intensive care unit (micu) at vanderbilt university medical center exclusion criteria: * age\<18 years old

Keywords: pilot projects plasmalyte a ringer's lactate sodium chloride critical care resuscitation"
efficacy and safety of a cutaneous formulation of gonyautoxin 2/3 (gtx 2/3) for the treatment of facial wrinkles

Conditions: Facial Wrinkles

Summary: the main objective of the trial is to determine whether the current topical formulation of gtx 2/3 reduces the wrinkling of the skin (crow's feet) after a single application other evaluation criteria include: safety assessment and local tolerance, depth of facial wrinkles (video microscopy imaging).

this is a single volunteer group study. each volunteer will be her own control. a volunteer will receive the active product containing cream on one side of her face and will receive the placebo cream on the other side.

Eligibility criteria:
inclusion criteria: * women with no bearing-child potential or with adequate birth control method. * volunteers between 30 to 60 years of age. * subjects with bilateral crow's feet wrinkles. * regular user of cosmetic products, willing and able to comply with the study objectives. * signed informed consent. exclusion criteria: * any medical condition or any use of a medication that could modify the study results (e.g.: nsaids, immunosuppressant drugs, insulin...). * any other significant medical condition (e.g.: diabetes mellitus, heart disease, liver disease...). * any other condition that in the investigator's opinion could not be appropriate with the participation in this trial. * any health condition that could affect the evaluation of study parameters. * acute or chronic skin disease. * history of allergic reaction to cosmetic compounds. * pregnancy, planned pregnancy or breast-feeding. * allergy to shellfish, fish or sea product (seaweed). * known or suspected hypersensitivity to any of the study product compounds. * participation in another clinical trial within 30 days previous to enrolment. * known or suspected alcohol or drug abuse.

Keywords: gonyautoxin
leucine enriched essential amino acid powder as an add-on to a classic ketogenic diet in refractory epilepsy

Conditions: Refractory Epilepsy; Drug Resistant Epilepsy

Summary: the main purpose of this study is to evaluate the safety and tolerability of a leucine-enriched essential amino acid (leaa) powder as an add-on to a classic ketogenic diet (kd) in pediatric and adult patients with refractory epilepsy.

this is a single center, single-arm, open label study to evaluate the safety, tolerability, and nutritional effect of leucine-enriched essential amino acid powder (leaa) when added to classical kd in pediatric and adult patients whose epilepsy is insufficiently controlled on the diet. the study will enroll patients who have previously been compliant with their classical kd regimen for at least 28 days prior to enrollment and have experienced some response (≥40% reduction in seizures), but not complete response (\<90% reduction in seizures) to dietary management with kd. study duration is 84 days and will have 3 remote study visits (baseline- remote visit 1, dose adjustment- remote visit 2, and final- remote visit 3) and a pre-screening communication via telephone/video.

Eligibility criteria:
inclusion criteria: 1. male or female patients ages 2 years and up at enrollment. 2. a diagnosis of epilepsy, with at least 2 seizures per week according to the parent/guardian report to study staff and investigator medical notes if applicable. all seizure types allowed. 3. under stable treatment with a classic ketogenic diet (kd) regimen with a kd ratio ≥ 1:1, with or without antiseizure medications (asms), for at least 28 days with documented, partial response (≥40% reduction in seizures), but not a complete response (\<90% reduction in seizures) based on patient medical records or parental report. 4. patient and/or parent/caregiver able and willing to follow all study procedures and successfully complete the study. exclusion criteria: 1. patients who have changed their kd regimen or antiseizure medication (asm) or vagus nerve stimulation (vns) within the last 28 days. 2. allergy, sensitivity to, or inability to metabolize any component of leucine enriched essential amino acid (leaa). 3. those who are pregnant or breastfeeding. 4. patients who have received an investigational drug or product or participated in a drug study within 4 weeks before the first dose of leucine enriched essential amino acid (leaa) powder. 5. patients who have a clinically significant condition or have had either clinically relevant symptoms or a clinically significant illness in the 4 weeks prior to the baseline visit 1, other than epilepsy, that would negatively impact study participation, collection of study data, or pose a risk to the patient including liver disease. 6. patients with history of suicidal ideation in past 6-months and suicidal behavior in past 2-years

Keywords: refractory epilepsy ketogenic diet leucine-enriched essential amino acid
donor peripheral stem cell or bone marrow transplant in treating patients with relapsed or refractory metastatic kidney cancer

Conditions: Kidney Cancer

Summary: rationale: a peripheral stem cell transplant or bone marrow transplant from a brother or sister may be an effective treatment for kidney cancer. purpose: this phase ii trial is studying how well a donor peripheral stem cell or bone marrow transplant works in treating patients with relapsed or refractory metastatic kidney cancer.

objectives: * determine the efficacy of nonmyeloablative sibling allogeneic peripheral blood stem cell transplantation in patients with relapsed or refractory metastatic renal cell carcinoma. * determine the toxic effects of this regimen in these patients. outline: this is a pilot study. * conditioning regimen: patients receive cyclophosphamide iv on days -7 and -6 and fludarabine iv on days -5 to -1. patients receiving 5/6-mismatched cells also receive anti-thymocyte globulin iv on days -5 to -3. * allogeneic peripheral blood stem cell (pbsc) infusion: patients undergo allogeneic pbsc or bone marrow transplantation on day 0. * graft-versus-host disease (gvhd) prophylaxis: patients receive oral mycophenolate mofetil twice daily on days 0-30. patients receive tacrolimus iv continuously or orally twice daily beginning on day -2 and continuing up to day 44-100 in the absence of gvhd. * donor lymphocyte infusion: patients with partial or complete t-cell chimerism receive up to 3 donor lymphocyte infusions in the absence of gvhd or progressive disease. after completion of study treatment, patients are evaluated periodically for 3 years. projected accrual: a total of 35 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed metastatic renal cell carcinoma * relapsed or refractory disease * tumor not amenable to complete surgical resection * no bone metastases only * no untreated brain metastases * measurable disease * available sibling donor who is hla-identical or who has a mismatch at a single hla locus (i.e., a 6/6 or 5/6 match at the hla-a, -b, and -dr loci) patient characteristics: performance status * ecog 0-2 life expectancy * not specified hematopoietic * not specified hepatic * bilirubin \< 3 mg/dl renal * creatinine \< 2 mg/dl * no untreated hypercalcemia cardiovascular * lvef ≥ 40% pulmonary * dlco ≥ 40% other * not pregnant or nursing * fertile patients must use effective contraception * negative pregnancy test * hiv-1 and -2 negative * no uncontrolled infection * no other active malignancy except basal skin cancer or carcinoma in situ of the cervix prior concurrent therapy: * at least 15 days since prior treatment for renal cell carcinoma * no other concurrent anticancer therapy

Keywords: recurrent renal cell cancer stage iv renal cell cancer
autologous cord blood transfusion in preterm infants

Conditions: Anemia of Prematurity

Summary: the purpose of this study is to investigate the efficacy and safety of autologous cord blood transfusions in very-low-birth-weight premature infants, and to evaluate the developmental outcomes of the infants who received autologous transfusions.

blood transfusions have many risks including transfusion reactions and infections. cord blood is accepted as an alternative method for red cell transfusions in low-birth weight (lbw) premature newborns. however, experience and scientific evidence concerning in-vivo efficacy and safety of red blood cell (rbc) concentrates derived from cord blood in very lbw premature newborns is still insufficient. a total of 50 umbilical cord blood (ucb) collected from infants born before 32 weeks' gestational age and processed into autologous rbc products. infants requiring blood transfusion were randomly assigned to an autologous or allogeneic product. two randomized groups were compared on the 14th, 28th, 35th days and \>35th days with respect to hemoglobin levels, transfusion numbers, transfusion and phlebotomy volumes, and hemoglobin, reticulocyte counts and erythropoietin levels in the postconceptional 36th and 40th weeks' gestation, and hemoglobin levels at postnatal 6-months age. all transfused infants were developmentally assessed by the end of the postnatal first year.

Eligibility criteria:
inclusion criteria: * preterm infants born at ≤ 32 weeks gestational age * parental consent exclusion criteria: * rhesus incompatibility * hydrops fetalis * maternal viral or bacterial infections including suspected chorioamnionitis * parental refuse

Keywords: umbilical cord blood premature autologous transfusion allogeneic transfusion
activation patterns of respiratory muscles to loaded inspiratory muscle tests in healthy adults under different posture

Conditions: Accessory Muscle

Summary: whether minimizing sternocleidomastoid (scm) activation in supine position would increase diaphragm activation during loaded inspiratory muscle tests remains to be determined. therefore, the purpose is to exam diaphragm and scm activation during loaded inspiratory muscle tests in sitting and supine position in healthy adults.

inspiratory muscle training usually performed in the upright sitting position. in healthy individuals, sternocleidomastoid (scm) is rarely recruited during tidal breathing, but previous studies have demonstrated scm activation during loaded inspiratory muscle tests in upright sitting position. whether minimizing scm activation in supine position would increase diaphragm activation during loaded inspiratory muscle tests remains to be determined. therefore, the purpose is to exam diaphragm and scm activation during loaded inspiratory muscle tests in sitting and supine position in healthy adults.

Eligibility criteria:
inclusion criteria: * age \> 20 years old * without exercise habit (any exercise that less than 3 days/week) * can cooperate with the measurements of this study exclusion criteria: * any clinical diagnosis that will influence the measurement, including any history of neuromyopathy * angina, acute myocardial infarction in the previous one month * pregnancy * participated in inspiratory muscle training program in the previous three months * any psychiatric or cognitive disorders, for example: mini-mental state examination (mmse) \< 24, that will disturb the communication and cooperation of the study
effects of aprepitant/dexamethasone versus mertazepine /dexamethasone on postoperative nausea and vomiting

Conditions: Nausea and Vomiting, Postoperative

Summary: laparoscopic sleeve gastrectomy (lsg) is an emerging treatment modality among the various types of surgical approach to obesity (1). the incidence of ponv in obese patients undergoing bariatric surgery, who did not receive antiemetic prophylaxis, is high at nearly 70-80 % (2,3). postoperatively, bariatric patients appear to suffer from nausea and vomiting more frequently than normal weight or obese patients.

currently, available interventions for ponv prophylaxis, especially as monotherapy, lack universal efficacy. use of combination therapies with different pharmacological basis is likely to bring down rates of ponv. (6) intravenous dexamethasone (8-10mg) reduces the incidence of ponv, minimizing activity of phospholipase a2 and blocking the expression of cyclooxygenase (cox)2 mrna that reduce production of prostaglandin and control the release of endorphins. aprepitant has demonstrated powerful additive effects when combined with dexamethasone and a 5-ht3 to prevent both acute and delayed chemotherapy-induced nausea and vomiting (cinv), and in the prevention of postoperative nausea and vomiting (ponv) the use of mirtazapine in the management of nausea and vomiting has been reported for both treatment and premedication

Eligibility criteria:
inclusion criteria: * asa physical status i or ii * body mass index (bmi) ≥ 35 kg/cm-2 exclusion criteria: * patients with gastrointestinal disorders, * patients with significant major organ disease, * patients received antidepressant drugs, * patients received an anti-emetic drug within 48 h before surgery, * patients on treatment with systemic glucocorticoids within 4 weeks before surgery.
frequency of parasite infection in hyraxes and sandflies during outbreak of leishmania tropica epidemic in the west bank

Conditions: Cutaneous Leishmaniasis

Summary: the objective of the project is to study the pathogenesis of leishmania tropica infection in a focus of infection, to learn about relationship of infection in humans with ecological factors such as infection in hyraxes reservoir hosts and vector sandflies


Eligibility criteria:
inclusion criteria: * people living on regular basis in peduel (the site of current leishmania tropica epidemic)with and without cutaneous signs of leishmania infection exclusion criteria: * none

Keywords: leishmania tropica hyrax sandfly
imatinib discontinuation in patients with chronic myeloid leukemia chronic phase with sustained mr4log

Conditions: Leukemia, Myeloid, Chronic-Phase

Summary: this study will evaluate the proportion of subjects with chronic myeloid leukemia chronic phase that sustain major molecular response after imatinib discontinuation. to be eligible for this protocol, the subject must have received imatinib as first line regiment for at least 3 years with sustained molecular response of 4log (rm4log) or higher for one year.

patients will be followed for 2 years, with molecular monitoring, every month in the first year and then every 2 months. imatinib will be restarted if the major molecular response (rm3log) is lost during the study or if the subject withdraw the informed consenting. the primary objective is to measure the number of subject that sustain the major molecular response (rm3log or bcr-abl level below 0.1%) after 2 years of follow-up. bcr: breakpoint cluster region abl: abelson murine leukemia rm3log: major molecular response, bcr-abl level below 0.1% (is)

Eligibility criteria:
inclusion criteria: * chronic myeloid leukemia chronic-phase, defined by the world health organization criteria * treatment with imatinib for at least 36 months * bcr-abl levels below 0,01% (is) or mr4log in the last 12 months exclusion criteria: * previous allogeneic stem cell transplantation * previous treatment with dasatinib, nilotinib, bosutinib or ponatinib * imatinib dose escalation at any time, due to loss or inadequate response * bcr-abl mutation is: international scale mr4log: molecular response of 4log or \<0,1% (is)
incisional correction of corneal astigmatism during phacoemulsification

Conditions: Astigmatism

Summary: today, cataract surgery is regarded as refractive surgery, mainly aiming emmetropia, and this makes eliminating corneal astigmatism is critical. corneal astigmatism of more than 1 diopter has been reported in up to 45% of the cataract surgery candidates. it is possible to reduce pre-existing corneal astigmatism by creating a clear corneal incision at the steep meridian of the cornea, however; creating a small incision can correct the only astigmatism up to 1 diopter, and sometimes this method may not be easy to perform due to the location of steep meridian like the difficulty while creating a superonasal or inferonasal incision at the left eye. this approach is usually sufficient for correcting astigmatism less than 1 d in most eyes. an opposite side clear corneal incision (occi) could enhance the flattening effect on the cornea.


Eligibility criteria:
inclusion criteria: * clear cornea * no history of previous ocular surgery * central corneal thickness (cct) \<640 exclusion criteria: * irregular corneal astigmatism or lenticular astigmatism * corneal opacities or pathology like fuch's endothelial dystrophy * previous ocular surgeries like glaucoma surgery or pkp or pterygium excision * posterior segment diseases and pathology * complicated phacoemulsification
anti-adhesive effect and safety of "thermo-sensitive adhesion barrier (mediclore)"

Conditions: Adhesion; Thyroidectomy

Summary: one of most important complication of thyroid surgery is adhesion. there are many anti-adhesive materials, but none of them showed significant outcomes. the investigators planned double blind prospective study of "thermo-sensitive adhesion barrier (mediclore)" to reveal anti-adhesive effect of mediclore. the investigators will recruit total 90 patients (control group 45, experimental group 45) and compare postoperative outcomes about adhesion.


Eligibility criteria:
inclusion criteria: * planned to perform thyroidectomy due to thyroid nodule * no evidence of distant metastasis or invasion to adjacent organ in thyroid cancer * normal preoperative vocal cord movement * normal preoperative laboratory study exclusion criteria: * uncontrolled hypertension, diabetes, chronic renal failure, coagulopathy * history of keloid or hypertrophic scar * graves disease or hashimoto thyroiditis patients * aspirin or anticoagulant medication within 7 days * radiation exposure to the head and neck * previous operation to the neck * history of allergic reaction to drugs * pregnant women
the effect of noise control during anesthesia induction in laparoscopic cholecystectomy surgery

Conditions: Cholecystectomy, Laparoscopic; Noise; Anesthesia Induction

Summary: this study aims to determine the effects of active and passive noise control method and headphone usage and noise level during anesthesia induction in laparoscopic cholecystectomy surgery on hemodynamic parameters, pain, nausea and vomiting, and recovery time from anesthesia in patients after surgery.

when the studies in the literature are examined, there is no study evaluating the effects of noise level and active and passive noise control method and headphone usage during anesthesia induction on patients undergoing laparoscopic cholecystectomy surgery, which is the most frequently applied among laparoscopic surgeries. this study aims to eliminate these deficiencies in the literature, to reveal the benefits of active and passive noise control headphone usage for noise control as it is an easy and cheap method and has no side effects, and to popularize this application.

Eligibility criteria:
inclusion criteria: * patients aged between 18-65, * diagnosed with cholecystitis or cholelithiasis, * planned for elective laparoscopic cholecystectomy, * have an asa i or asa ii anesthesia classification, * oriented to person, place and time, * undergoing general anesthesia, * not having a psychiatric or cognitive/mental disease (dementia etc.), * not having vision, hearing and communication problems, * speaking, reading and writing turkish, * patients who agree to participate in the study verbally and in writing will be included. exclusion criteria: * patients who underwent spinal anesthesia, * transferred to units such as intensive care after surgery, * underwent emergency laparoscopic cholecystectomy, * patients who were planned for elective open cholecystectomy will not be included in the study.

Keywords: anesthesia induction noise control laparoscopic cholecystectomy
a study of safety, tolerability and pharmacokinetics of nivolumab in chinese subjects with previously treated advanced or recurrent solid tumors

Conditions: Solid Tumors

Summary: the purpose of this study is to determine whether nivolumab is safe and effective in the treatment of advanced or recurrent solid tumors in chinese subjects.


Eligibility criteria:
inclusion criteria: * chinese subjects with advanced or recurrent solid tumors exclusion criteria: * subjects with brain metastases are excluded unless clinically stable for more than 2 weeks at the time of enrollment as determined by the investigator * subjects with carcinomatous meningitis are excluded
a trial of ciclesonide in adults with mild-to-moderate covid-19

Conditions: COVID-19

Summary: according to in vitro studies, ciclesonide showed good antiviral activity against severe acute respiratory syndrome coronavirus 2 (sars-cov-2). although some cases were reported for the clinical effectiveness of ciclesonide in the treatment of covid-19, there is no clinical trial to evaluate the antiviral effect on the reduction of viral load in patients with covid-19. in this study, we aimed to investigate whether ciclesonide inhalation could eradicate sars-cov-2 compared to standard supportive care in patients with mild covid-19.


Eligibility criteria:
inclusion criteria: * patients with mild covid-19 (news scoring system 0-4) * patient within 7 days from symptom onset or patient within 48 hous after laboratory diagnosis (sars-cov-2 rt-pcr) exclusion criteria: * hypoxia (sao2 \<95%) * unable to take oral medication * unable to use inhaler * pregnancy or breast feeding * immunocompromising conditions * moderate/severe renal dysfunction : creatinine clearance (ccl) \< 30 ml/min * moderate/severe liver dysfunction: ast or alt \> 5 times upper normal limit * asthma or chronic obstructive lung disease

Keywords: sars-cov-2 ciclesonide viral load coronavirus