Kornimate/medical-research-clean huggingface dataset:
the preoperative administration of icg improves tumor detection in patients undergoing minimally invasive hepatic resection guided by conventional intraoperative ultrasound.

Conditions: Liver Tumor; Surgery

Summary: summary: preoperative administration of indocyanine green (icg) improves the detection of liver tumors in patients undergoing minimally invasive liver resection guided by conventional intraoperative ultrasound. the primary objectives of this study are to evaluate the efficacy of icg fluorescence uptake in combination with intraoperative ultrasonography and preoperative magnetic resonance imaging for detecting liver tumors. additionally, a machine-learning algorithm will be developed to enhance liver tumor detection using icg through photographic analysis. secondary objectives include investigating the distribution of icg in liver tissue and its correlation with hepatic fibrosis and steatosis, as well as describing patterns of icg uptake and their relationship with liver tumors. the study also aims to analyze various clinical outcomes such as the 30-day comprehensive complication index, operation time, conversion to open surgery rate, length of hospital stay, liver tumor recurrence, readmission rate, complications, and 90-day mortality. this research seeks to advance tumor detection methods and improve patient outcomes in minimally invasive liver resection procedures.


Eligibility criteria:
inclusion criteria * patients with liver tumors with an indication for minimally invasive surgery, evaluated by the hospital's multidisciplinary liver tumor board (mdtb). * contrast enhanced mri within 6 weeks prior to liver surgery * ≥18 years old * absence of exclusion criteria and able to provide consent for data collection and analysis exclusion criteria * emergency surgery * patients in which icg is contraindicated: previous history of iodine hypersensitivity, patients with renal failure (gfr \<60 ml/min/1.73 m2), uremia, clinical hyperthyroidism, autonomic thyroid adenomas, or focal and diffuse autonomic abnormalities of the thyroid gland. * previous liver surgery.
efficacy and safety of hd-6277 in adult patients with inadequate control of type 2 diabetes mellitus by diet and exercise

Conditions: Type 2 Diabetes Mellitus

Summary: a multi-center, double-blind, randomized, placebo-controlled, parallel-group, phase 2 study to assess the efficacy and safety of hd-6277 in adult patients with inadequate control of type 2 diabetes mellitus by diet and exercise


Eligibility criteria:
inclusion criteria: * diagnosis of t2dm with hba1c between 7.0% and 10.0% (inclusive) while on diet and exercise alone for at least 6 weeks prior to screening. exclusion criteria: * type 1 diabetes or another immune-mediated diabetes syndrome
a trial of neoadjuvant chemotherapy + surgery vs. surgery for bulky stage i/ii cervical cancer

Conditions: Cervical Neoplasms

Summary: to investigate the clinical benefits of neoadjuvant chemotherapy for bulky stage i/ii cervical cancer

we designed this randomized study to investigate the clinical benefits of neoadjuvant chemotherapy for bulky stage i/ii cervical cancer. patients with figo stage i/ii with bulky disease are randomized to either neoadjuvant chemotherapy (bomp: cisplatin 14mg/m2 day 1-5, bleomycin 7mg day 1-5, mitomycin 7mg/m2 day 5, and vincristine 0.7mg/m2 day every 21 days for 2-4 cycles followed by radical hysterectomy or radical hysterectomy alone. the primary endpoint is overall survival and the secondary endpoints are progression-free survival, complication of surgery, completeness of radical hysterectomy, omission of postsurgical irradiation, completeness of postsurgical irradiation, response rate, and adverse events. a total 200 patients (100 per treatment arm) planned to accrue for this study within 5.5 years.

Eligibility criteria:
inclusion criteria: 1. untreated cervical cancer 2. pathologically diagnosed squamous carcinoma 3. figo stage ib2, iia (\>4cm), and iib 4. measurable lesions 5. possible to radical hysterectomy 6. age: 20 to 70 years 7. ps: 0 and 1 8. wbc \> 3,000/mm3, hb \> 9.0g/dl, platelet \> 100,000 /mm3, sgot/sgpt \ 80 torr, normal ecg 9. written informed consent exclusion criteria: 1. patients who have any evidence of the other cancer present within the last 5 years with the exception of carcinoma in situ or intramucosal cancer those are curable with local therapy 2. women during pregnancy or breast-feeding 3. patients with psychiatric illness 4. patients who have active infection 5. patients who have uncontrolled diabetes or uncontrolled hypertension 6. patients who have positive hbs 7. patients who have had heart failure, unstable angina, or myocardial infarction within the past 6 months 8. patients with interstitial pneumonitis or pulmonary fibrosis 9. patients who are unable to undergo radical hysterectomy for complication of excessive obesity, liver cirrhosis, or bleeding tendency

Keywords: cervical cancer drug therapy cisplatin bleomycin mitomycin vincristine
a study on induced weight gain during atypical antipsychotic treatment and its management with psychoeducational programme

Conditions: Weight Gain

Summary: olanzapine is an atypical antipsychotic agent indicated for the treatment of schizophrenia and moderate to severe manic episode. olanzapine is among the many antipsychotic agents associated with weight gain . the mechanism for antipsychotic drug-related weight gain is not known, although antagonism of serotonin receptors, especially the 5ht2c , and histamine receptors has been hypothesized. the purpose of this study is to observe the efficacy of a psychoeducational programme in managing the increased weight as a side effect of the olanzapine treatment. interventions to prevent weight gain associated with olanzapine should at least include periodic monitoring and recommendations for changes in diet and physical activity. this is a phase iv, randomised, parallel study of subjects previously treated with olanzapine as antipsychotic monotherapy, which have shown an increase of b.m.i. \>7% from the beginning of antipsychotic treatment (assessed during the routine visits). for the first 12 weeks of the trial approximately 60 outpatients, enrolled in one site during a period of one year, will be randomised in a 1:1 ratio into 2 treatment groups: olanzapine + psychoeducational programme or olanzapine alone. in the following 12 weeks of the study all patients undergo the psychoeducational programme. the efficacy of this programme will be assessed monitoring the mean difference from baseline to endpoint in total body weight and bmi.


Eligibility criteria:
inclusion criteria: * all patients, previously treated with olanzapine as antipsychotic monotherapy, which have shown a weight gain with an increase of bmi \>7% (assessed during the routine visits from the beginning of antipsychotic treatment). * male or female subjects at least 18 and no more than 65 years of age. * subjects must be considered reliable. * each subject must have a level of understanding sufficient to perform all tests and examinations required by the protocol. * each patient, (and a patient's legal representative if mandated by local law), must understand the nature of the study and must sign an informed consent document. exclusion criteria: * serious, unstable illnesses such that death is anticipated within 1 year or intensive care unit hospitalization for the disease is anticipated within 6 months. this includes hepatic (specifically any degree of jaundice), renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic diseases (specifically current agranulocytosis with an absolute neutrophil count \<500 mm3). * prior treatment with any antipsychotic drugs associated to olanzapine. * judged clinically to be at significant suicidal or homicidal risk and/or agitated enough to necessitate use of restraints.
etanercept for non-infectious lung injury following bone marrow transplantation

Conditions: Respiratory Distress Syndrome, Adult; Bronchiolitis Obliterans; Pneumonia

Summary: the purpose of this study is to determine the effects of etanercept, and define the toxicity, when administered to patients with acute non-infectious lung injury (idiopathic pneumonia syndrome, ips) and with subacute pulmonary dysfunction after allogeneic stem cell transplantation.

over the last 2 decades, allogeneic bone marrow transplantation (bmt) has emerged as an important treatment option for a number of malignant and non-malignant disorders. unfortunately, pulmonary dysfunction remains a frequent and severe complication of allogeneic bmt. one of the main chemicals felt to cause lung damage is tumor necrosis factor (tnf). etanercept is an experimental drug that attempts to block tnf lung damage. patients will undergo blood tests, x-rays, and a bronchoscopy with broncho-alveolar lavage prior to treatment with etanercept to check for infection. if no infection is evident after 24 hours, the etanercept will be started and administered twice weekly for 4 weeks by subcutaneous injection. there will be weekly blood tests and bronchoscopy after the last drug dose.

Eligibility criteria:
inclusion criteria: * diagnosis of acute idiopathic pneumonia syndrome (ips) or sub-acute lung injury * at least 1 year of age for ips stratum * at least 6 years of age for sub-acute lung injury stratum and able to perform formal pulmonary function testing * at least 14 days since prior treatment with an investigational drug for graft-versus-host disease * previously treated with allogeneic stem cell or bone marrow transplantation for primary disease exclusion criteria: * documented evidence of active systemic or pulmonary infection * cardiogenic failure as cause of pulmonary dysfunction * known hypersensitivity to etanercept * currently receiving dialysis * currently receiving inotropic medications except dopamine * pregnant or nursing

Keywords: tnfr-fc fusion protein stem cell transplantation transplantation, homologous respiratory function tests
a study of tak-861 for the treatment of narcolepsy type 1

Conditions: Narcolepsy Type 1

Summary: the main aim of this study is to learn how effective tak-861 is in improving excessive sleepiness during the day (called excessive daytime sleepiness or eds) after 3 months of treatment. other aims are to learn how effective tak-861 is in lowering the number of sudden, unexpected attacks of muscle weakness while staying conscious (cataplexy) in a week; to learn the effect tak-861 has on participants' ability to maintain attention, participant's overall quality of life, the spectrum of narcolepsy symptoms, and daily life functions; and to learn about the safety of tak-861.

the drug being tested in this study is called tak-861. tak-861 is being tested to evaluate its efficacy and safety in people with narcolepsy type 1 (nt1). the study will enroll approximately 152 patients. participants will be randomly assigned (by chance, like flipping a coin) to one of the three treatment groups: 1. tak-861 dose 1 2. tak-861 dose 2 3. placebo the study drug will be administered for 12 weeks. this multi-center trial will be conducted globally.

Eligibility criteria:
inclusion criteria: 1. the participant has a body mass index (bmi) within the range 18 to 40 kilograms per meter square (kg/m\^2). 2. the participant has an international classification of sleep disorders, third edition (icsd-3) or international classification of sleep disorders, third edition, text revision (icsd-3-tr) diagnosis of nt1. 3. the participant has greater than or equal to (≥)4 partial or complete episodes of cataplexy/week (wcr). 4. the participant is positive for the human leukocyte antigen (hla) genotype hla-dqb1\*06:02 or results from radioimmunoassay indicate the participant's cerebrospinal fluid (csf) orexin (ox)/hypocretin-1 concentration is less than or equal to (≤)110 picograms per milliliter (pg/ml) \[or less than one-third of the mean values obtained in normal participants within the same standardized assay\]. exclusion criteria: 1. the participant has a current medical disorder, other than narcolepsy with cataplexy, associated with eds. 2. the participant: (a) has a history of myocardial infarction; (b) has a history of clinically significant hepatic disease, thyroid disease, coronary artery disease, cardiac rhythm abnormality or heart failure; or (c) has any medical condition (such as unstable cardiovascular, pulmonary, renal or gastrointestinal disease). 3. the participant has current or recent (within 6 months) gastrointestinal disease that is expected to influence the absorption of drugs. 4. the participant has a history of cancer in the past 5 years. 5. the participant has a clinically significant history of head injury or head trauma. 6. the participant has a history of epilepsy, seizure, or convulsion. 7. the participant has a history of cerebral ischemia, transient ischemic attack (\<5 years from screening), intracranial aneurysm, or arteriovenous malformation.

Keywords: drug therapy
study for pre-surgical weight loss in type ii diabetes patients

Conditions: Type 2 Diabetes; Obesity

Summary: the purpose of this study is to determine whether the gi sleeve is safe and effective in treating type ii diabetes patients

patients with obesity are at significantly greater risk of developing complications such as pulmonary dysfunction, diabetes, hypertension, and other co-morbid risks. nih panel recommendations state that even a 10% short-weight loss would greatly reduce these risks. gi dynamics' gi sleeve represents a viable alternative to other short-term pre-surgical weight loss methods. gi sleeve is a device that can be implanted and removed through minimal invasive endoscopic techniques. this endoscopic procedure brings potential benefits to patients in that it is minimally invasive, efficacious, and allows patients to recover faster with less morbidity and mortality.

Eligibility criteria:
inclusion criteria: * age 18 to 65 * bmi 40 to 60 * type ii diabetes * candidates for bariatric surgery exclusion criteria: patients with * hepatitis b or c * gastroesophageal reflux disease (gerd) * hiv positive diagnosis * pancreatitis * conditions of gastrointestinal tract, such as ulcers or crohn's * an infection or who are h. pylori positive

Keywords: type 2 diabetes
botulinum toxin in burning mouth syndrome

Conditions: Burning Mouth Syndrome

Summary: the effect of botulinum neurotoxin type a intradermal injection in will be evaluated in 4 patients with clinical diagnosis of burning mouth syndrome involving the anterior two-thirds of the tongue and the lower lip for at least 6 months, refractory to common pharmacological treatments. pain severity will be measured by the visual analog scale (vas) indicating average week pain before injection. each patient will be injected with a total dose of 16 units (dilution: 2 ml saline) of incobotulinuma: 4 units into each side of the lower lip and 4 units into each antero-lateral side of the tongue. in order to determine if a placebo effect may be involved, we will inject 2 additional patients with saline solution using the same volumes and the same injection sites. patients will be evaluated at 48 hours and then at 4, 8, 12, 16 and 20 weeks after the treatment. patients treated with placebo will be treated after 4 weeks with incobotulinuma with the same dose reported above.


Eligibility criteria:
inclusion criteria: * burning mouth syndrome exclusion criteria: * any other mouth disorder
a study that evaluates the decrease in irritation when using additional acne treatment products

Conditions: Acne Vulgaris

Summary: this study is to see if there's any difference in the amount of facial irritation when two acne products are used together on one side of the face, compared to one acne treatment product used alone on the other side of the face. all people participating in this trial will be required to return to the same study center every weekday for two weeks for the investigator to check for irritation on the face and to have the products applied - on weekends they will have to put them on at home. if one side of the face is more irritated than the other side, a picture will be taken as well.

this is an investigator-blind, randomized, balanced study comparing two treatment regimens in a split-face model. all subjects will apply retin-a micro gel (tretinoin) 0.1 % pump, and aczone gel (dapsone) 5% daily to one side of the face (with 1 hour between applications, applying aczone gel first) and retin-a micro gel 0.1 % pump to the other side of the face in a randomized scheme for two consecutive weeks. subjects will return to the study center daily for evaluation and for application of both products (weekend applications will be done at home). at each visit the subject will be evaluated and scored for irritation and cutaneous treatment effects. subjects presenting with differences in irritation between one side of the face and the other will be photographed and have chromometer readings taken. a single treatment center is expected to enroll at least 24 subjects.

Eligibility criteria:
inclusion criteria: * fitzpatrick skin type i, ii or iii with healthy skin as judged by the investigator * bilateral skin is clear of any confounding irritation, rashes, acne, rosacea, etc., prior to study start * subjects are willing to avoid applying emollients or cosmetics to the face 24 hours before they start, and during the study * if subject is of childbearing potential, subject has been using a protocol-approved method of birth control for a certain amount of time, and is willing to continue using it throughout the study exclusion criteria: * subjects who are pregnant or nursing, or intend to be during the study * subjects with any condition or medical history, or using any drug or medication, that might negatively affect the subject's safety or the validity of study results, either as listed in the protocol or in the opinion of the investigator * subjects who have facial hair that may obstruct or hinder the evaluation of any reactions * subjects who use any known photosensitizing agents

Keywords: acne irritation
hepatectomy with or without the thoraco-abdominal approach

Conditions: Surgery; Liver Tumors; Hepatectomy; Liver Resection

Summary: the performance of hepatectomy for liver tumors using the thoraco-abdominal approach (taa) versus the abdominal approach (aa) is still debated. the aim of the study is the analysis of the perioperative outcome of patients operated with or without the taa for liver tumors.

the prospectively maintained database was queried. a 1:1 propensity score-matched analysis was applied. among 744 patients, 246 undergoing hepatectomy with taa and 246 undergoing hepatectomy with aa were compared. these patients were matched for baseline characteristics, underlying liver disease, comorbidity, tumor features, and extent of the resection. the rates of morbidity and mortality were the study endpoints.

Eligibility criteria:
inclusion criteria: * first liver surgery; * any type of malignant liver tumor, including hepatocellular carcinoma on cirrhosis. exclusion criteria: * previous history of liver surgery; * any type of benign liver tumor; * incomplete clinical, surgical, pathological or postoperative data; * patients treated with radiofrequency ablation alone or in combination with surgery were also excluded.
parallel-group study to assess the effect of rasagiline on cognition in patients with parkinson's disease

Conditions: Parkinson's Disease

Summary: this is a 24-week, multicenter, randomized, double-blind, placebo-controlled, add-on, parallel-group study to evaluate the effect of rasagiline on cognitive function in adults with mild cognitive impairment (mci) in parkinson's disease (pd-mci).


Eligibility criteria:
inclusion criteria: 1. nondemented man or woman 45 through 80 years of age with idiopathic parkinson's disease (pd) based on the united kingdom (uk) parkinson's disease society brain bank clinical diagnostic criteria 2. hoehn and yahr stage ≥ 1 (symptoms on only 1 side of the body) with treatment and ≤ 3 (mild-to-moderate bilateral disease; some postural instability; physically independent) 3. mild cognitive impairment in parkinson's disease based on the movement disorder society (mds) task force diagnostic criteria and the montreal cognitive assessment (moca) rating scale (range, 20-25, inclusive) 4. medically stable outpatient, based on the investigator's judgment 5. the patient is on a stable dopaminergic medication regimen for ≥ 30 days before entering the study (screening/baseline visit) 6. other inclusion criteria apply; please contact the site for more information exclusion criteria: 1. clinically relevant history of vascular disease (eg, stroke) 2. history of melanoma 3. history of deep brain stimulation (dbs) 4. impaired hepatic function, based on the investigator's judgment 5. psychosis or is receiving antipsychotic treatment 6. clinically significant or unstable medical or surgical condition that may preclude safe and complete study participation, based on the investigator's judgment 7. other exclusion criteria apply; please contact the site for more information

Keywords: parkinson's disease cognition rasagiline
study of perinatal transmission of zidovudine-resistant hiv among pregnant women treated with zidovudine

Conditions: HIV Infections; Pregnancy

Summary: to identify patterns of zidovudine ( azt ) susceptibility among mother/infant pairs with perinatal hiv transmission. most hiv-infected infants acquire their disease via perinatal transmission. since transmission of hiv-resistant strains to infants could alter the course of disease and response to currently recommended treatment, a study to assess the patterns of azt susceptibility among mother/infant pairs with perinatal transmission is essential to delineate future therapeutic strategies.

most hiv-infected infants acquire their disease via perinatal transmission. since transmission of hiv-resistant strains to infants could alter the course of disease and response to currently recommended treatment, a study to assess the patterns of azt susceptibility among mother/infant pairs with perinatal transmission is essential to delineate future therapeutic strategies. hiv-infected pregnant women are enrolled at 20-36 weeks gestation. patients have blood drawn for hiv culture at study entry and at delivery. infants have blood drawn for hiv culture at delivery and at 1, 3, 6, and 18 months of age.

Eligibility criteria:
inclusion criteria prior medication: required: * at least 6 months of prior azt, including continuously during the current pregnancy. patients must have: * hiv seropositivity. * cd4 count \<= 300 cells/mm3. * gestational age of 20-36 weeks, with intention to carry pregnancy to term. * at least 6 months of prior azt therapy, including continuous azt therapy during the current pregnancy. exclusion criteria co-existing condition: patients with the following symptoms or conditions are excluded: * evidence of pre-existing fetal anomalies that would preclude survival to the end of the study, such as anencephaly, renal agenesis, or potter's syndrome. concurrent medication: excluded: * antiretrovirals other than azt.

Keywords: pregnancy pregnancy complications, infectious acquired immunodeficiency syndrome aids-related complex zidovudine drug resistance, microbial disease transmission, vertical