Kornimate/medical-research-clean huggingface dataset:
clinical trial to assess the safety and efficacy of sodium stibogluconate (ssg) and ambisome® combination, miltefosine and ambisome® and miltefosine alone for the treatment visceral leishmaniasis in eastern africa

Conditions: Primary Visceral Leishmaniasis

Summary: this study is to assess if shorter combinations of ssg plus single dose ambisome®, miltefosine plus single dose ambisome® and miltefosine alone are effective in treating visceral leishmaniasis in eastern africa.

the current study intends to look at potential feasible short course combination therapies as well as evaluate (and possibly register) miltefosine in its conventional dose against vl in sudan and kenya.

Eligibility criteria:
inclusion criteria: * patients with clinical signs and symptoms of vl and diagnosis confirmed by visualization of parasites in tissue samples (lymph node, bone marrow or spleen where relevant) on microscopy. * patients aged between 7 (to allow for blood sampling) and 60 years (inclusive) who are able to comply with the protocol. * patients for whom written informed consent has been signed by the patients themselves (if aged 18 years and over) or by parents(s) or legal guardian for patients under 18 years of age. * hiv negative status exclusion criteria: * patients who have received any anti-leishmanial drugs in the last 6 months/ relapse cases. * patients with a negative lymph node/bone marrow (or spleen) smears. * patients with severe protein and or caloric malnutrition (kwashiorkor or marasmus ; adults: bmi \</= 15, children w/h\<70, presence of oedema) * patients with previous history of hypersensitivity reaction to ssg or amphotericin b. * patients suffering from a concomitant severe infection such as tb or any other serious underlying disease (cardiac, renal, hepatic) which would preclude evaluation of the patient's response to study medication. * patients suffering from other conditions associated with splenomegaly such as schistosomiasis. * patients with previous history of cardiac arrhythmia or an abnormal ecg * patients who are female of child bearing age (all females who have achieved menarche) / pregnant or lactating. * patients with haemoglobin \< 5gm/dl. * patients with wbc \< 1 x 10³/mm³. * patients with platelets \< 40,000/mm³. * patients with abnormal liver function (alt and ast) tests of more than three times the normal range. * patients with serum creatinine outside the normal range for age and gender. * major surgical intervention within 2 weeks prior to enrolment.

Keywords: phase ii randomised clinical trial visceral leishmaniasis
dna biomarkers in tissue samples from patients with osteosarcoma

Conditions: Localized Osteosarcoma; Metastatic Osteosarcoma; Recurrent Osteosarcoma

Summary: this research study is studying dna biomarkers in tissue samples from patients with osteosarcoma. studying samples of tumor tissue and blood from patients with cancer in the laboratory may help doctors learn more about changes the occur in dna and identify biomarkers related to cancer. dna analysis of tumor tissue may also help doctors predict how well patients will respond to treatment.

objectives: i. to comprehensively detect genomic, epigenomic, and transcriptomic aberrations in tissue samples from patients with osteosarcoma that may play a role in chemoresistance and metastasis using high-resolution genome-wide technologies. ii. to identify recurrent genetic mutations involved in the pathogenesis of osteosarcoma, especially for the development of chemoresistance and metastatic tumors. iii. to identify and validate these biomarkers for new therapeutic targets for patients with osteosarcoma, especially those with metastatic disease and whose tumors are resistant to standard chemotherapy. outline: this is a multicenter study. archived tumor tissue and peripheral blood dna specimens are analyzed for dna copy number profiling, gene expression profiling, dna methylation profiling, microrna profiling, and genomic resequencing. clinical data including demographics; date of diagnosis, surgery, chemotherapy, recurrence, progression, and death; imaging; toxicity; and pathologic data elements associated with the specimens are also collected and analyzed.

Eligibility criteria:
inclusion criteria: * diagnosis of osteosarcoma * fresh-frozen samples collected at the time of diagnosis with matchedblood dna (preferred) from patients enrolled on the following osteosarcoma biology protocols: * cog-p9851 * cog-aost06b1 * available clinical outcome data * not specified * not specified
the neuro-epigenetics biomarkers of postoperative delirium in elderly patients undergoing hip/knee replacement

Conditions: Postoperative Delirium

Summary: introduction: postoperative delirium (pod), an acute, transient, fluctuating disturbance in attention, cognition, and level of consciousness, is a common (15-53%) postoperative complication, and it is associated with longer hospital stays, worse functional outcomes, higher healthcare costs, and increased mortality. however, at the current time, effective prevention and treatment are not only hampered by lack of knowledge about the neuropathogenesis of pod but also by a lack of biomarkers that could predict individual risk and assess diagnosis and severity of pod. recent studies have focused on inflammatory markers (il-1, il-6, il-8, il-10, crp), alzheimer's disease-related factors (tau, aβ40/42), and nerve injury factors (s100β, nse), but failed to establishing causality between these markers and pod. furthermore, these results were contradictory. previous study of the investigators found that the dysregulation of preoperative microrna (mir)-146a and mir-181c in cerebrospinal fluid (csf) and serum was associated with the development and severity of pod. therefore, the investigators hypothesized these neurimmirs and other neuro-epigenetics biomarkers might participate in the neuropathogenesis of pod. purpose: aims to search for neuro-epigenetics biomarkers to predict and diagnose pod.

method: 1. study design: this study is a prospective investigation that searches for neuro-epigenetics biomarkers to predict and diagnose pod. 2. inclusion criteria / exclusion criteria inclusion criteria: eligible patients were at least 65 years old and were scheduled to have hip/knee replacement. exclusion criteria: 1. a past medical history of neurological or clinically evident neurovascular disease (e.g., alzheimer's disease, other forms of dementia, stroke); 2. patients diagnosed with malignant or benign tumors; 3. mini-mental state examination (mmse) scores of 26 or less; 4. american society of anesthesiologists (asa) score \[a global score that assesses the physical status of patients before surgery, ranging from 1 (normal health) to 5 (moribund)\] greater than 3; 5. a history of alcohol abuse and drug dependence; 6. inability to read or severe visual or auditory deficits; 7. unwillingness to comply with the protocol or procedures.

Eligibility criteria:
inclusion criteria: eligible patients were at least 65 years old and were scheduled to have hip/knee replacement. exclusion criteria: 1. a past medical history of neurological or clinically evident neurovascular disease (e.g., alzheimer's disease, other forms of dementia, stroke); 2. patients diagnosed with malignant or benign tumors; 3. mini-mental state examination (mmse) scores of 26 or less; 4. american society of anesthesiologists (asa) score greater than 3; 5. a history of alcohol abuse and drug dependence; 6. inability to read or severe visual or auditory deficits; 7. unwillingness to comply with the protocol or procedures.
mhealth smartphone app and postpartum glucose intolerance for patients with gdm

Conditions: Gestational Diabetes; PreDiabetes; Pregnancy Related; Pregnancy, High Risk

Summary: without intervention, approximately 70% of women diagnosed with gdm will develop type 2 diabetes mellitus in their lifetime. abnormal results of a 2 hour oral glucose tolerance test (ogtt) performed as early as 2 days postpartum are predictive of impaired glucose tolerance 1 year postpartum. the investigators hypothesize that use of the malama smartphone application to optimize antenatal glycemic control will result in lower incidence of postpartum glucose intolerance, which may decrease long term risk of progression to diabetes mellitus.

the effect of smartphone applications for gestational diabetes management on risk of postpartum glucose intolerance, antenatal glycemic control, and other perinatal outcomes is unknown. this study is a randomized control trial in which patients diagnosed with gestational diabetes will be randomized to use of the malama app vs. standard care as described above. the primary aim of the study is to investigate if the incidence of postpartum glucose intolerance is lower in patients using the malama app for gestational diabetes management compared to patients receiving standard care. secondary outcomes that will be investigated include several markers of maternal and neonatal perinatal morbidity. maternal outcomes that will be investigated include postpartum hemoglobin a1c level, interval pregnancy weight gain, incidence of hypertensive disorders of pregnancy, cesarean delivery, operative delivery, postpartum hemorrhage, and advanced perineal lacerations. neonatal secondary outcomes include gestational age at delivery, birthweight and incidence of large for gestational age infants, shoulder dystocia, nicu admission, length of nicu stay, neonatal blood glucose nadir, and need for neonatal iv glucose support.

Eligibility criteria:
inclusion criteria: 1. pregnant women receiving prenatal, delivery, and postpartum care at tufts medical center 2. gestational diabetes diagnosed between 14 0/7 and 31 6/7 weeks gestation on basis of 1-hour glucose challenge test result of \>=200 mg/dl or carpenter-coustan criteria 3. \>= 18 years of age 4. literate in english or spanish (?additional languages pending app translation) 5. access to or ownership of a smartphone compatible with malama 6. willing and able to sign the informed consent exclusion criteria: 1. unable to tolerate oral glucose tolerance test (i.e. history of gastric bypass surgery) 2. diagnosis of pregestational diabetes 3. prescribed medications for chronic disease that affect glucose metabolism (e.g., long term oral steroids) 4. does not own smartphone compatible with malama application 5. severe life-limiting fetal anomaly
comparison of cerebral artery pressure gradient and cerebral blood flow measured by arterial spin labeling

Conditions: Stroke, Ischemic; Intracranial Atherosclerosis

Summary: the goal of this observational study is to explore the ability of intravascular pressure gradients to identify hemodynamic disturbance in patients with intracranial atherosclerotic diseases (icas). the main questions that aim to answer are: * the correlation between intravascular pressure gradient and cerebral blood flow (cbf) * the threshold for intravascular pressure gradients to predict hemodynamic disturbance in icas patients will undergo intravascular pressure measurement and arterial spin labeling (asl) for cbf during pre- and post-operation respectively.


Eligibility criteria:
inclusion criteria: 1. patients aged 40 years or older. 2. patients with transient ischemic attack (tia) or nondisabling ischemic stroke caused by a focal icas lesion located in intracranial anterior circulation (vertebral artery, basilar artery or intracranial internal carotid artery and their major branches). 3. 50% to 99% stenosis (calculated by modified wasid method) of responsible arterial occlusion, confirmed by digital subtraction angiography (dsa). 4. informed of the study protocol and objectives. exclusion criteria: 1. non-atherosclerotic mca stenosis 2. combined with moderate or severe stenosis of other extracranial and intracranial arteries 3. previous endovascular treatment or surgery for cerebrovascular diseases 4. large cerebral infarction (more than 1/2 mca perfusion area) 5. combined with other neurological diseases, such as aneurysm, arteriovenous malformation, tumor, hydrocephalus, cerebral trauma, cerebral hemorrhage, multiple sclerosis, epilepsy and intracranial infection. 6. vascular abnormality or stunting, resulting in the impossibility of endovascular intervention 7. liver and kidney dysfunction, or severe allergy to the contrast agent 8. severe coagulation dysfunction 9. pregnancy or in the preparation for pregnancy 10. patients who cannot tolerate or do not allow mr screening, including metal implanting and claustrophobia 11. patients with severe dementia or mental disorders, who cannot cooperate with examination

Keywords: intracranial atherosclerotic diseases fractional flow reserve intravascular pressure gradients cerebral blood flow arterial spin labeling
early orthodontic treatment of dental crowding

Conditions: Dental Crowding

Summary: aim of the study is to compare treatment duration and effects of orthodontic treatment of dental crowding between treatments started at different stages of mixed dentition phase. the randomized controlled trial study will be conducted in a public health care center.


Eligibility criteria:
inclusion criteria: * dental developmental stage of mixed dentition * crowding on both dental arches * skeletal discrepancy not suspected exclusion criteria: * national criteria for publicly funded treatment not met by the severity of the malocclusion * other malocclusions * angle class iii relationship of the molars * malocclusion related to a syndrome * non-compliance to orthodontic treatment
investigation of pharmacokinetics and safety of hrs-7535 in subjects with hepatic impairment and normal hepatic function

Conditions: Diabetes Mellitus

Summary: the study is being conducted to compare the pharmacokinetics and safety of hrs-7535 in subjects with mild to moderate hepatic impairment and normal hepatic function.


Eligibility criteria:
inclusion criteria: 1. ability to understand the study procedures and methods, participate voluntarily and be able to complete the study according to the protocol requirements, and sign the informed consent form (icf) in writing. 2. aged 18-70 years old on the date of signing the icf (including the threshold), both male and female. 3. at the time of screening, male subjects weighing no less than 50 kg and female subjects weighing no less than 45 kg; body mass index (bmi): 18\~32 kg/m2 (including the threshold). exclusion criteria: 1. in the judgment of the investigator, may be allergic to the study drug or its components. 2. smoking an average of more than 10 cigarettes per day within 3 months prior to screening. 3. alcoholics of within 3 months prior to screening, who consume more than 14 units of alcohol per week (1 unit=beer)360 ml of alcohol, or 45 ml of strong liquor with an alcohol content of 40%, or 150 ml of wine. 4. history of drug or substance abuse, or a positive urine drug test at screening. 5. donated or lost ≥ 400 ml of blood within 3 months prior to screening. 6. individuals with a history of severe hypoglycemia. 7. undergone surgery within 6 months prior to screening, or plan to undergo surgery during the trial period.
6-month extension trial of asenapine with olanzapine in negative symptom patients who completed the protocol 25543 (25544)(p05777)

Conditions: Schizophrenia

Summary: this is an extension study to further test the efficacy and safety of asenapine compared with a marketed agent (olanzapine) in the treatment of patients with persistent negative symptoms of schizophrenia.


Eligibility criteria:
inclusion criteria: * continue to meet all demographic and procedural inclusion criteria of the 25543 trial (nct 00212836; p05817) to enter into this extension trial. * have demonstrated an acceptable degree of compliance and completed the 25543 trial, and would benefit from continued treatment according to the investigator. exclusion criteria: * have an uncontrolled, unstable clinically significant medical condition. * have been judged to be medically noncompliant in the management of their disease.
follow-up after surgery for colon cancer. general practice vs. surgical-based follow-up?

Conditions: Colon Cancer

Summary: the purpose of this study is to clarify cost effectiveness and quality of life issues among colon cancer patients followed up in a hospital setting or by their gp's.statement of study hypothesis:postoperative follow up of colon cancer patients (according to national guidelines) by general practitioners will not have any influence on patients' quality of life. there will not be observed any increase in serious clinical events and cost effectiveness will be improved.


Eligibility criteria:
inclusion criteria: * surgery for colon cancer (including rectosigmoid) with histological grade duke stages a, b or c. * completion of postsurgical chemotherapy (dukes stage c patients). * informed consent. exclusion criteria: * patients with rectal cancer defined as cancer within 15 cm from anus. * a poor health status or operative complications making it natural to perform follow up by specialists. * additional cancer diagnoses. * disseminated cancer. * poor mental status.

Keywords: colonic neoplasms/surgery* continuity of patient care* follow-up studies quality of life patient satisfaction
bioequivalence study for benzyl alcohol lotion 5%.

Conditions: Head Lice

Summary: to establish the therapeutic equivalence and safety of a generic benzyl alcohol lotion 5% with ulesfia lotion 5% in eradication of head lice in the study subjects.


Eligibility criteria:
inclusion criteria: * healthy males or non-pregnant females aged 6 month or over with an upper age limit of 60 years. * prospective participants upon examination are confirmed to have at least 3 live head lice (defined as lice adults or nymphs) and at least 5 viable appearance louse eggs (nits). * prospective participants who give written informed consent or, if the participant is under 17 years of age, whose parent/guardian gives written informed consent to participate in the study. * prospective participants who will be available for follow up visits over the 21 days following first treatment. * prospective female participants (including female caregivers) of childbearing potential who are willing to provide a urine pregnancy test. * prospective participants who agree not to shave their hair or use any other pediculicide, nit combing, or louse treatment method during the course of the study. exclusion criteria: * prospective participants with a known sensitivity to any of the ingredients in benzyl alcohol lotion 5% (hi-tech pharmacal inc) or ulesfia 5% (shionogi inc). * prospective participants with a known history of irritation or sensitivity to pediculicides or hair care products. * prospective participants with a secondary bacterial infection of the scalp (eg. impetigo/pyoderma) or have a secondary or long term scalp condition that could make it difficult to evaluate the extent and severity of an infestation or that would present a problem in the evaluation of response to therapy (e.g., psoriatic lesions of the scalp, extensive seborrheic dermatitis). * prospective participants who have been treated with other head lice products within 4 weeks prior to randomization. * prospective participants who regularly shave their hair, have bleached their hair, used a permanent color on their hair, or their hair has been permanently straightened or waved within the previous 2 weeks. * prospective participants who have been treated with trimethoprim containing products within the previous 4 weeks, or who are currently taking such a course. * females who are pregnant, planning to become pregnant, during the course of the study period, or are currently breast feeding mothers. * females of childbearing potential who are unwilling to use an adequate method of contraception from at least 4 weeks prior to the first application of treatment and until 4 weeks after the last application of treatment, or who are unwilling to take a urine pregnancy test. * prospective participants who have participated in another clinical study or used an investigational new drug within 1 month before entry into this study. * participants who have already participated in this clinical study.
safety, tolerability and pd activity of inhaled tpi 1020 versus inhaled budesonide in copd patients

Conditions: Copd Bronchitis

Summary: this study will assess and compare the safety and tolerability of inhaled tpi 1020 (repeated nominal doses; 500 μg bid x 6 weeks) versus inhaled budesonide (repeated doses; 800 μg bid x 6 weeks) and a matching placebo. pharmacodynamic (pd) activity on fev1, sputum and blood cells and cytokines will also be studied.

a multi-centre, randomized, placebo and active-controlled, 6-week study of inhaled tpi 1020, inhaled budesonide or matching placebo (random allocation of eligible patients to the three treatments at a ratio of 3:3:1), to evaluate the safety, tolerability and pharmacodynamic activity of tpi 1020 in 42 evaluable copd subjects.

Eligibility criteria:
inclusion criteria: * outpatients, male or female, smoker or ex-smoker (who quit at least a year ago) with a smoking history equal or greater than 10 pack years. * age between 40 and 80 years old with a diagnosis (for at least 12 months) of mild to moderate copd exclusion criteria: * copd exacerbations indicated by a treatment with oral or systemic glucocorticosteroids and/or hospitalization and/or clinically relevant respiratory infection requiring antibiotics within 3 month of the start of the study. * failure to produce a sufficient sputum sample during the screening sputum induction procedure, required for tcc and differential cell count determination.
reliability and validity of the spinal cord injury secondary conditions scale

Conditions: Spinal Cord Injuries; Reliability; Validity

Summary: people living with spinal cord injury (sci) experience a range of secondary health conditions that impact their quality of lives. the spinal cord injury secondary conditions scale (sci-scs) is a 16-item questionnaire that assess secondary health conditions in persons with sci. the total score of sci-scs range from 0 to 48 and is derived by adding the scores for each item. higher scores indicate greater problems with secondary conditions. the investigators aimed to determine the reliability and cross-cultural validation of the turkish translation of the sci-scs.

after translation and back translation of the sci-scs, 93 patients between the ages of 18 and 78 years with sci, american spinal injury association impairment scale grades from a to d and at least 6 months after injury were assessed. participants rated the sci-scs 2-3 day apart, and test-retest agreement was investigated. factor analysis was done and convergent validity was investigated by correlating the sci-scs with the spinal cord injury spasticity evaluation tool (sci-set), functional ambulation categories (fac), 36-item short form health survey (sf-36), and spinal cord independence measure iii (scim-iii).

Eligibility criteria:
inclusion criteria: patients between the ages of 18 and 80 years with sci, american spinal injury association impairment scale grades from a to d and at least 6 months after injury. those who volunteered to participate in the study. exclusion criteria: * patients with sci for less than 6 months * patients with impaired cognitive functions, * patients with other neurological diseases, * patients with malignancy