Kornimate/medical-research-clean huggingface dataset:
chemotherapy plus bone marrow transplantation in treating patients with metastatic melanoma

Conditions: Melanoma (Skin)

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. combining chemotherapy with bone marrow transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. purpose: clinical trial to study the effectiveness of chemotherapy plus bone marrow transplantation in treating patients with metastatic melanoma that has not responded to previous therapy.

objectives: i. determine the response rate and survival of patients with metastatic malignant melanoma who have failed first-line therapy when treated with match-related allogeneic bone marrow transplantation. outline: this is a pilot study. patients receive a preparative regimen of busulfan and cyclophosphamide. busulfan po is administered every 6 hours on days -7 to -4. cyclophosphamide iv is administered on days -3 to -2 followed by one day of rest. bone marrow infusion occurs on day 0. cyclosporine begins on day -1 and continues until day 180. methotrexate iv is administered on days 1, 3, 6, and 11. granulocyte colony-stimulating factor is administered as a continuous iv every 2 hours starting on day 12 and continuing until absolute neutrophil count is greater than 1,000 g/dl for 2 consecutive days. patients receive weekly follow up for the first 180 days and monthly thereafter. patients are followed until death. projected accrual: 6 patients with melanoma will be accrued.

Eligibility criteria:
disease characteristics: biopsy proven relapsed malignant melanoma that has failed prior standard regimen for metastatic disease must have hla-matched or related bone marrow donor (5- or 6-antigen match) no history of cns metastases patient characteristics: age: 16 to 44 performance status: ecog 0-2 life expectancy: at least 3 months hematopoietic: not specified hepatic: sgot and sgpt less than 1.5 times upper limit of normal bilirubin less than 1.5 mg/dl renal: creatinine less than 1.5 mg/dl and/or creatinine clearance greater than 75 ml/min cardiovascular: no history of cardiac disease no symptomatic cardiac disease ejection fraction greater than 50% pulmonary: fev1 greater than 50% predicted (greater than 75% if received thoracic irradiation) dlco greater than 50% predicted other: not pregnant fertile women must use effective contraception hiv negative no active bacterial, fungal, or viral infection hepatitis b negative prior concurrent therapy: at least 1 prior standard regimen for metastatic disease

Keywords: recurrent melanoma
the population pharmacokinetics of montelukast in infants and children

Conditions: Asthma

Summary: the investigators' aim was to evaluate the population pharmacokinetics of montelukast in infants and children and define the appropriate dose in order to optimize montelukast treatment in this vulnerable population.


Eligibility criteria:
inclusion criteria: * patients have been diagnosed with asthma; age range: 1 month to 12 years old; montelukast used as part of regular treatment. exclusion criteria: * expected survival time less than the treatment cycle; patients with other factors that researcher considers unsuitable for inclusion.
role of 13c methacetin breath test in predicting prognosis among patients with acute or acute on chronic liver failure (aclf).

Conditions: Acute Liver Failure; Acute on Chronic Liver Failure

Summary: blood will be collected after venepuncture from all patients for complete blood counts, serum bilirubin (direct and indirect), aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, gamma glutamyl transferase, prothrombin time and inr, urea, creatinine, sodium, potassium, serum total protein and albumin, within 24 hours after admission and twice a week there after or as and when needed. time line for blood tests and evaluation of clinical parameters \& 13c-mbt for alf patients: on days 0, 1, 3, and 7 for aclf patients: on days 0, 7 (week 1), 14(week 2), 28 (weeks 4) blood tests would include: serum bilirubin (total and direct), aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase, gamma-glutamyltransferase, serum proteins (total and albumin), prothrombin time \& international normalized ratio (inr), serum urea and creatinine, serum electrolytes, arterial ammonia and arterial blood gas analysis.


Eligibility criteria:
inclusion criteria: - all patients presenting with acute liver failure and acute on chronic liver failure (between 18 - 70 years of age) to institute of liver \& biliary sciences (ilbs), new delhi, india. exclusion criteria: 1. patients with significant co-morbid illnesses such as cardiovascular or respiratory or intrinsic renal diseases which by themselves may have a bearing on the outcome. 2. patients with previous intestinal bypass surgery for morbid obesity 3. patients with extensive small bowel resection 4. patients currently receiving total parenteral nutrition 5. pregnant women 6. patients with history of allergy to paracetamol 7. patients on steroids or anti-fungal agents 8. patients in encephalopathy 9. patients unwilling to participate in the protocol 10. patients on medications which can alter the activity of cyp 1a2 enzymes such as corticosteroids, amiodarone, tetracycline, niacin, valproic acid, methotrexate, stavudine and zidovudine.
a pilot study of pet-ct in the assessment of pulmonary nodules in children with malignant solid tumors

Conditions: Pulmonary Nodules

Summary: because the management of children with solid tumors hinges on the extent of disease, it is crucial to identify metastatic sites. helical chest computed tomography (ct) is the standard method of excluding pulmonary metastases. however, ct lacks molecular information regarding nodule histology and often biopsy is required to exclude malignancy. biopsy procedures carry known risks including those associated with anesthesia and sedation, infection, pneumothorax, hemorrhage, pain and other post-procedure and post-operative complications and may also add unnecessary cost to the management of the patient. we found that the ability of three experienced pediatric radiologists to correctly predict nodule histology based on ct imaging features was limited (57% to 67% rate of correct classification). also, there was only slight to moderate agreement in nodule classification between these reviewers. furthermore, of 50 children who have undergone pulmonary nodule biopsy at st. jude in the last five years, 44% (22/50) had only benign nodules. adult studies have shown that a nuclear medicine scan called fluoro-deoxyglucose (fdg) positron emission tomography (pet) and the fusion modality pet-ct are superior to diagnostic ct in distinguishing benign from malignant pulmonary nodules because fdg pet gives information about the metabolic activity of the nodule. nodules that are malignant have more metabolic activity, hence more fdg uptake/intensity, than those that are benign. there has been little work done in children to determine the value of pet or pet-ct in the evaluation of pulmonary nodules.

in this study, we seek to assess the feasibility of performing pet-ct for the evaluation of pulmonary nodules in children to obtain preliminary data for sample size determination for a larger multi-institutional trial. the primary objective of the multi-institutional trial will be to compare the accuracy of diagnostic ct alone to pet-ct in distinguishing benign from malignant nodules in children with solid malignancies. we are hopeful that pet-ct will allow us to better direct the clinical management of these patients and to reduce the number of invasive procedures performed to confirm the presence of benign disease.

Eligibility criteria:
inclusion criteria: * participant has a known or clinically suspected solid malignancy (excluding brain tumor) * nodule must be discovered at the time of diagnosis of the primary malignancy or after the completion of therapy exclusion criteria: * participant has not been off therapy for at least 3 weeks before undergoing pet-ct

Keywords: pulmonary nodules
study to evaluate a single dose of sti-2020 (covi-amg™) in adults with mild covid-19 symptoms

Conditions: Covid19

Summary: this study investigates the safety, pharmacokinetic (pk) profile and efficacy of a single injection of covi-amg in outpatient adults with mild covid-19 symptoms.

this is a multi-center, randomized, double-blind study designed to investigate the safety, pharmacokinetic (pk) profile and efficacy of a single injection of covi-amg in outpatient adults with mild covid-19 symptoms. subjects will be followed for approximately 70 days post dosing.

Eligibility criteria:
inclusion criteria: * positive for covid-19 by an approved antigen test * mild symptoms consistent with a covid-19 viral infection * willing and able to comply with all planned study procedures and be available for all study visits and follow-up as required by the protocol * willing to follow contraception guidelines exclusion criteria: * evidence of moderate covid-19 per fda severity categorization * pregnant or lactating and breast feeding or planning on either during the study * has a documented infection other than covid-19 * has received a covid-19 vaccine * has participated, or is participating, in a clinical research study evaluating covid-19 convalescent plasma, monoclonal antibodies (mabs) against sars-cov-2, or intravenous immunoglobulin (ivig) within 3 months or less than 5 half-lives of the investigational product (whichever is longer) prior to the screening visit

Keywords: covid-19
efficacy of fibrin sealant to reduce the amount of post-thyroidectomy drain

Conditions: Thyroid Carcinoma; Thyroidectomy

Summary: fibrin sealant has been studied to reduce post-thyroidectomy drain and hospital stay as well. however, no strong evidence from well-designed clinical trials is available. harmonic scalpel is a ultrasonic vibrating scissors which makes it easy to cut and coagulate the tissues, thus reducing op time and postoperative drain, which is important to minimize hospital stay. the investigators hypothesized that fibrin sealant combined with harmonic scalpel-assisted procedure could guarantee no-drain postoperative care in total thyroidectomy with anterior compartment neck dissection.


Eligibility criteria:
inclusion criteria: * proven thyroid carcinoma * thyroidectomy with anterior compartment neck dissection exclusion criteria: * no use of harmonic scalpel during surgery * coagulation abnormality * refuse to participate

Keywords: neck dissection
subconjunctival versus direct mitomycin c in trabeculectomy

Conditions: Open Angle Glaucoma

Summary: trabeculectomy is routinely used as a surgical treatment for open angle glaucoma. success of trabeculectomy is greatly augmented by the use of antimetabolites to inhibit wound healing, specifically mitomycin c (mmc). mmc can be applied to the eye at various sites, concentrations and times. this study aims to compare the two application routes that are commonly employed: subconjunctival pre-operative injection and intraoperative direct scleral application in terms of iop lowering effect, bleb appearance and complications.

trabeculectomy is widely used as a surgical treatment of uncontrolled open glaucoma. success of trabeculectomy at halting or slowing glaucoma progression primarily relies on the extent of conjunctival and sclera wound healing. the success rates of trabeculectomy increased dramatically with the introduction of anti-metabolites. for more than two decades mitomycin-c (mmc), a chemotherapeutic agent capable of decreasing fibroblast activity and modulating wound healing at the bleb, has been used with trabeculectomy. the complications of mmc are well known and several studies have described various methods of application based on exposure time, dose and surface area. numerous retrospective and prospective studies have compared the efficacy of mmc applied beneath the conjunctival flap with soaked sponges versus intrascleral application. in 2008, lee et al. first described an alternative route of application: subconjunctival injection of mmc directly into the intra-tenon area. seventy-six eyes with primary and secondary open angle glaucoma underwent trabeculectomy with this approach and were followed for one year post-operatively. eighty-six percent of eyes achieved an iop \ 20% below baseline without medications or additional surgery) was greater in the injection group at 3 years. the sponge group experienced more encapsulated blebs but complication rates were similar in both groups. to date, there have been no prospective studies comparing the iop-lowering efficacy and safety of intra-tenon injection versus direct scleral application of mmc.

Eligibility criteria:
inclusion criteria: * medically uncontrolled glaucoma * healthy and freely mobile conjunctiva in superior bulbar region exclusion criteria: * previous incisional glaucoma surgery * no light perception vision * pregnant or nursing women * iris neovascularization or proliferative retinopathy * iridocorneal endothelial syndrome * chronic or recurrent uveitis * steroid-induced glaucoma * pathologic myopia or refractive error less than -6.00 diopters * unwillingness or inability to give consent * inability to return for scheduled protocol visits

Keywords: trabeculectomy, mitomycin-c, glaucoma
study of the effect of once a week risedronate on the microstructure of tibia and radius using a new scanning method

Conditions: Osteopenia

Summary: the primary purpose of the protocol is to evaluate the sensitivity of 3d-pqct (3d-peripheral quantitative computed tomography) technology to detect minute changes in bone microarchitecture.

the 3d-pqct equipment allows the evaluation of changes occurring within the bone at "microarchitecture" level, without the need for invasive bone biopsies. the primary objective is to evaluate the sensitivity of the technology to detect a difference between those treated with risedronate 35mg oaw (once a week) or placebo. early phase postmenopausal women with osteopenia have been chosen because they have a more rapid and higher level of bone loss during the first few years of the menopause.

Eligibility criteria:
inclusion criteria: * cessation of menstruation (surgical or natural) between 6 and 36 months prior to study enrollment; * osteopenic * must have at least 1 evaluable radius and tibia, without history of fracture (traumatic or atraumatic) * bmi (body mass index) between 18 and 28 kg/m2 inclusive; exclusion criteria: * history of any generalized bone disease, including hyperparathyroidism, paget's disease of bone, renal osteodystrophy, or any other acquired or congenital bone disease; or any known condition that would interfere with the assessment of dxa (dual-energy x-ray absorptiometry) at either the lumbar spine (3 non-evaluable lumbar vertebrae at lumbar spine l1 - l4) or the femoral neck. * clinical or radiological evidence of osteoporosis, such as atraumatic vertebral compression fracture (\* 20% reduction in anterior-to-posterior or middle-to-posterior height ratio; or 20% reduction of the anterior, middle, and/or posterior height as compared with the adjacent vertebrae) documented by spinal x ray or a history of osteoporosis-related atraumatic fracture of the hip or of the wrist; * glucocorticoid-induced osteopenia; * previous bisphosphonate therapy;
sex, psychopharmacology, and diabetes

Conditions: Schizophrenia; Schizophrenia Spectrum and Other Psychotic Disorders; Diabetes Mellitus; PreDiabetes; Sexual Dysfunction; Drug-Related Side Effects and Adverse Reactions; Education

Summary: the term sexual (sd) dysfunction covers conditions that prevent people from having a satisfactory sex life. sd is a frequent and sometimes debilitating complication of mental illness and a known adverse reaction to psycho-pharmacological treatment. sd is also associated with diabetes, a common somatic comorbidity in psychiatric patients. sd is associated with both reduced quality-of-life and reduced treatment adherence, yet sd is far too rarely addressed between the patient and the healthcare professional in clinical consultations. the purpose of the study is to investigate whether targeted education of patients with schizophrenia and diabetes/prediabetes and/or their healthcare professionals in causes and management of sd: * increases the number of systematic examinations of sexual side effects, * causes changes in the psycho-pharmacological treatment, and * reduces the severity or perception of sexual side effects. the study is a multicenter randomized controlled trial (rct) with four arms, in which the educational intervention is provided to patients, healthcare professionals, or both groups. the effect of the educational intervention is compared to a non-educated control group. the study is expected to include 192 patients recruited from 16 assertive community treatment centers evenly distributed in four danish regions. the study is part of an interdisciplinary project named secret. the educational intervention was developed in an ethnographic pre-study incorporating stakeholder engagement. parallel to the present rct, an ethnographic field study will be carried out to broaden the perspective on the effects of the intervention.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * a diagnosis in the schizophrenic spectrum (icd10 f2x) * one of the following: 1. a diagnosis of diabetes (icd10 e10x, e11x, e12x, e13x, 14x) 2. a current or previous prediabetes defined as an hba1c between 39-47 mmol/mol (both included) measured in at least two blood samples collected with ≥3 months intervals as part of the patient's routine clinical monitoring 3. obesity defined as a body-mass index (bmi) ≥30 kg/m2 * ongoing treatment with at least one antipsychotic agent * a sd that can be rated using changes in sexual function questionnaire-14 (csfq-14) exclusion criteria: * incapacitated or subject to mental health probation * unable to speak danish

Keywords: randomized controlled trial treatment adherence and compliance antipsychotic agents patient education as topic
bed rest, alternate daily fasting and incretin effect

Conditions: Metabolic Syndrome; Type 2 Diabetes; Critical Illness

Summary: bed rest produces insulin resistance in healthy volunteers. in this study the investigators aim to investigate the effect of 8 days bed rest on the incretin effect and how alternate daily fasting affects cognitive function and the insulin resistance produced by bed rest. the subjects will be randomized to either 3 meals a day (isocaloric diet), alternate daily fasting or one meal/day every second day (25% of daily calorie need) and four meals/day every second (175% of daily calorie need). the investigators hypothesize: 1. bed rest reduces the incretin effect 2. alternate daily fasting improves the cognitive function (memory and concentration) compared to isocaloric diet 3. alternate daily fasting reduces insulin resistance produced by bed rest compared to isocaloric diet

all subjects will undergo 8 days of bedrest. outcome measures will be performed before, under and immediately after the bed rest period. the individual study period will be 10 days in total.

Eligibility criteria:
inclusion criteria: * bmi\<25kg/m2 * vo2 max normal for age exclusion criteria: * tobacco smoking * alcohol ingestion \> 14 units per week * diabetes in nearby relatives * resection of the small intestine * history of gastric bypass surgery * risk of deep venous thrombosis * female
ramosetron on late ponv (postoperative nausea and vomiting)

Conditions: Postoperative Nausea and Vomiting; Breast Cancer Female

Summary: the purpose of this study was to evaluate the effectiveness of additional ramosetron injection for controlling late postoperative nausea and vomiting (ponv) after breast surgery in high risk ponv patients. the investigators compared ponv amomng 3 groups- group c: no additional ramosteron, group b: two additional ramosteron doses at 12 hour interval, group m: two additional ramosetron doses mix to the intraveonus patient controlled analgesia.

the investigators included high risk patients of ponv with a score of 3 or more as measured by the apfel's score and over 18 years old who receive breast surgery and intravenous patient controlled analgesia. all patients was received ramosetron 0.3 mg at the end of surgery. the patients were evaluated for number of ponv (nausea, vomiting, retching) at 1, 6, 24, and 48 hours postoperatively. nausea was defined as an unpleasant feeling of vomiting. retching was defined as an excessive contraction or a regular movement. of the respiratory muscles where no gastric contents were excreted, and vomiting was defined as the excretion of gastric contents. ponv were further detailed quantified using the rinvr score (rhodes index of nausea, vomiting, and retching) which enabled the patients' objective and subjective symptoms to be evaluated as a simple and reliable methods. intravenous injection of ondansetron 4 mg was administered as a rescue antiemetic. the patients were evaluated 2 hours after ondansetron administration. if the symptom persisted, use of second rescue antiemetics dexamethasone 5 mg.

Eligibility criteria:
inclusion criteria: * age over 18 years * american society of anesthesiologists (asa) physical status i or ii * requesting iv pca (patient control of analgesia) for pain control * the high-risk group of ponv with a score of 3 or more as measured by the apfel's score. exclusion criteria: * emergency operation * re-operation * drug abuse, allergy * major organ disease (gastrointestinal, cardiovascular, respiratory, cerebral, renal or hepatic disease) * smoker * pregnancy * lactation * previously use of antiemetics or systemic steroids within 48 before surgery

Keywords: mastectomy postoperative nausea and vomiting ramosetron