Kornimate/medical-research-clean huggingface dataset:
study to determine the antiviral activity and safety of alovudine in nucleoside-experienced hiv-infected subjects experiencing virologic failure

Conditions: HIV Infections

Summary: the primary objective was to determine the mean change in hiv viral load from baseline to week 4 compared with placebo after 4 weeks of treatment in highly experienced hiv-infected patients. secondary objectives were to determine (1) the tolerability, hematologic and hepatic safety of different doses of alovudine and (2) the effect of baseline nucleoside genotypic susceptibility on virologic response after 4 weeks of alovudine administration


Eligibility criteria:
inclusion criteria: * signed informed consent before any trial procedure * hiv-1 infected males or females ≥18 years of age * screening genotypic resistance report indicating two or more of the following nucleoside reverse transcriptase inhibitors (nrti) resistance mutations: 41, 67, 70, 210 and 215 * stable nrti regimen without stavudine and zidovudine for at least 6 weeks before screening and stable antiretroviral (arv) background treatment for 3 months before screening * hiv-1 viral load ≥1000 copies/ml and \<75,000 copies/ml at screening * change in viral load between previous test within 3 months before screening, using local laboratory for routine tests, and screening test was \<1.0 log10 copies/ml * acceptable medical history, as assessed by the investigator * current stable arv medication regimen between screening (visit 1) and visit 2 exclusion criteria: * arv medication naïve * patients on recent drug holiday, defined as off arv medications for at least 7 consecutive days within the previous 3 months * female patients of child-bearing potential who : * have a positive serum pregnancy test * are breast feeding, * are planning to become pregnant, or * are not willing to use a barrier method of contraception * prior alovudine use * use of investigational medications within 30 days before study entry or during the trial * use of immunomodulatory drugs within 3 months before study entry or during the trial (e.g. interferon, cyclosporine, hydroxyurea, interleukin-2) * current use of rifampin, rifabutine, isoniazid, pyrazinamide, stavudine, zidovudine, ganciclovir, chronic use of hepatotoxic drugs, anti-tumour therapy or probenecid * laboratory values: * neutrophils of grade 2 or greater abnormality * hemoglobin of grade 2 or greater abnormality * platelets: grade 2 or greater abnormality * creatinine of ≥1.25 upper limit of the normal (uln) * lipase of grade 1 or greater abnormality * alanine aminotransaminase (alt) or aspartate aminotransaminase (ast) of grade 2 or greater abnormality * direct bilirubin of grade 1 or greater abnormality * cd4 ≤50 cells/mm3 * hepatitis b (+hbsag or +hbcab) or c +hepatitis c virus (+hcv ab ) co-infection, chronic hepatitis, on-going hepatitis or pancreatitis * any new or active aids-defining event within 30 days before study entry * inability to adhere to the requirements of the protocol, including active substance abuse as assessed by the investigator * in the opinion of the investigator, likely survival of less than 6 months because of underlying disease
skeletal health and bone marrow composition among youth

Conditions: Gender Dysphoria in Children; Puberty; Bone Development

Summary: children and adolescents experiencing gender dysphoria feel increased distress with the onset of puberty. gender clinics treat these young adolescents by "blocking" puberty using gonadotropin-releasing hormone (gnrh) agonist medications. this has the possibility of impacting bone development as sex steroids are important to bone mass development. in this multi-site study, the investigators will examine bone marrow composition (by mri) in 40 transgender youth and bone density and body composition before/after pubertal blockade compared to healthy participants.

the investigators propose to identify the effects of pubertal blockade on bone density and size in pediatric transgender individuals. information is limited regarding bone health and metabolism for this group, and especially for children who are transgender. further, the team's expertise in magnetic resonance imaging (mri), magnetic resonance spectroscopy (mrs), dual-energy x-ray absorptiometry (dxa), and peripheral quantitative computed tomography (pqct), examining the natal female skeleton in previous nih funded studies, and extensive clinical expertise, provide an ideal foundation to apply this protocol to examine transgender female and transgender male skeleton. findings from this study will allow us to identify potential preventative strategies to counter the long-term effects of puberty blockade such as osteoporosis and raise awareness of this medical consequence to medical care providers of transgender patients. the proposed project seeks to answer the clinically relevant question of how bone marrow composition relates to body composition, and its relation to both bone density and skeletal strength, in transgender patients who are undergoing puberty blockade, the first phase of therapy preceding gender-affirming hormone therapy.

Eligibility criteria:
inclusion criteria: 1. be willing to give informed consent/assent (parent or legal guardian able to provide informed consent) 2. tanner stage ii/iii 3. age 9-14 years old for assigned male at birth (amab) and 9-13 for assigned female at birth (afab) 4. current patient at the boston children's hospital transgender clinic or cincinnati children's hospital medical center clinic, within six weeks of initiating pubertal blockade treatment (e.g., gnrh agonist- lupron or vantas) 5. controls are matched on age within 2 years, race/ethnicity, sex assigned at birth and bmi within 25% exclusion criteria: the participant must not: 1. have chronic disease known to affect skeletal metabolism (e.g. cystic fibrosis, celiac disease, sickle cell disease, inflammatory bowel disease etc.) 2. receipt of other medications within previous 3 months known to affect skeletal metabolism (e.g., glucocorticoids, anticonvulsants, etc.) 3. have metal implants or hardware in their body that would not allow them to get an mri 4. have a diagnosis of a developmental disorder or claustrophobia that would prevent them from undergoing an mri
treatment of hairy cell leukaemia variant and relapsing hairy cell leukaemia with cladribine plus rituximab

Conditions: Hairy Cell Leukemia (HCL)

Summary: the study will test the effectiveness (rate of complete remissions, total remission rate and duration of remission) and toxicity of the combined immuno/chemotherapy with subcutaneous cladribine (litak®) plus anti-cd20\* antibody rituximab in patients requiring treatment for relapsed hairy cell leukaemia or hairy cell leukaemia variant independent of any previous therapy. cd20\* = cluster of differentiation antigen 20

the trial is a prospective, multi-centre, open phase ii study on patients with hairy cell leukaemia variant or with relapsed hairy cell leukaemia.

Eligibility criteria:
inclusion criteria: * patients with histologically verified hairy cell leukaemia (hcl) hairy cell leukaemia variant (hclv) or * relapse of hairy cell leukaemia after therapy with cladribine or pentostatin * need for treatment is indicated (see 4.3 below) * age at least 18 years * general state of health according to who 0-2 * written declaration of consent by the patient * current histology, which should not be older than 6 months, is necessary exclusion criteria: * patients, who do not fulfil the above-mentioned inclusion criteria. * patients with severe functional limitations of the heart according to new york heart association iii / iv, of the lung according to who degree iii / iv, the liver (bilirubin \> 2mg/dl, alkaline phosphatase, raised got and gpt (glutamate- pyruvate transaminase) values more than twice normal), diseases of the central nervous system, including psychoses. creatinine \> 2 mg/dl, or creatinine clearance \< 50 mg/min * patients with proven hiv infections * patients with active hepatitis * patients with other florid infections * patients with anamnesis / diagnosis of another malignant disease (other than nonmelanoma associated skin tumours or stage 0 in situ carcinoma of the cervix) * pregnant or lactating women

Keywords: hcl variant hcl relapse risk stratified
insomnia and sleep disturbances in chronic pain patients - relation to physical activity level and opioid use

Conditions: Chronic Pain; Insomnia; Exercise; Sleep; Sleep Disorder; Opioid Use

Summary: pain is one of the most common causes of healthcare contact and long-term sick leave, with negative consequences on physical and mental health. poor sleep is common in chronic pain patients. epidemiological studies indicate that 5-7% of patients with chronic pain are treated regularly with strong opioids. negative side effects of pain modulating drugs on sleep quality have been reported, which may have negative influence on overall disease management in chronic pain patients. however, to date there are conflicting results regarding the effects of opioids on sleep, since the pain relieving effect of opioids seem to affect sleep positively. there is data suggesting that physical activity has positive effects on both pain perception and sleep quality (and duration). the aim of the study is to explore insomnia and characteristics of sleep in patients with chronic pain and the relationship with physical activity level and opioid use.

one hundred participants with planned follow-up (decision according to clinical routine) at the pain centre will be consecutively recruited. after signed informed consent, the participants will wear two accelerometers during one week, one for recording sleep and one for recording physical activity. the participants will be asked to fill out a sleep and pain diary during the same week. furthermore, the participants will fill out questionnaires regarding sleep, life style, mental fatigue and self-efficacy. all study participant are included in the swedish quality registry for pain rehabilitation (sqrp). data from the sqrp will be used regarding patient health characteristics, pain and pain associated symptoms, health related quality of life, sleep and self-reported physical activity level. data regarding co-morbidity, drug use, pharmacological treatment and other interventions at the pain center will be collected from the patient charts. in addition, the participants blood pressure and neck circumference will be measured. blood samples will be analysed for biomarkers associated with pain and sleep disturbance.

Eligibility criteria:
inclusion criteria: * chronic pain (i.e. pain \> 3 months) * planned follow up at the pain centre * age ≥18 years * consents to participation in the study exclusion criteria: * inadequate knowledge of the swedish language * alcohol or substance abuse * severe untreated psychiatric disorders including psychiatric disease and/or psychological conditions which are the primary determinant to the patient's pain condition * malignant disease with short expected survival

Keywords: accelerometry mental fatigue self-efficacy
mild and rapidly improving stroke study

Conditions: Ischemic Stroke

Summary: the objective of this study is to determine the 90-day outcomes of mild and rapidly improving ischemic stroke.


Eligibility criteria:
inclusion criteria: * mild or spontaneously rapidly improving ischemic stroke confirmed by neuroimaging * arrival to hospital within 4.5 hours of symptom onset * willing to provide consent * available for a telephone interview at 30 and 90 days exclusion criteria: * onset \>4.5 hours * unable to provide informed consent (patient or legally appointed representative * premorbid modified rankin scale \>1 * unavailable by telephone for follow-up
resistance training program and cardiovascular exercise in increasing muscle mass in adolescent and young adult stem cell transplant survivors

Conditions: Malignant Neoplasm

Summary: this pilot trial studies how well a resistance training program and cardiovascular exercise work in increasing muscle mass in adolescent and young adult stem cell transplant survivors. resistance training and cardiovascular exercise may increase physical activity, muscular strength and improve lean body mass which is beneficial to improving the overall health of stem cell transplant survivors.

primary objectives: i. determine the feasibility of a 12-week resistance training (rt) intervention in adolescent and young adult (aya) hematopoietic cell transplant (hct) survivors starting +100 days post-hct. secondary objectives: i. examine the change from baseline of a rt intervention on muscle strength and body composition at day +200 and day +365. ii. determine the effectiveness of rt exercise on improving the cardio-metabolic risk factor profile at day +200 and day +365. iii. determine the effectiveness of rt exercise on improving quality of life (qol) measures. iv. compare day +80 and day +365 assessments to subjects in a historical control population. outline: patients undergo moderately intense aerobic/cardiovascular exercise over 30-60 minutes and complete 1-2 sets of 8 to 10 resistance/strength training exercises, 8 to 12 repetitions of each exercise, 3 days per week for 12 weeks. patients also participate in weekly phone calls with an exercise physiologist to ensure adherence to the program and to provide support. after completion of study intervention, patients are followed up within 2 weeks, then at 365 days post hct.

Eligibility criteria:
inclusion criteria: * \> 80 days but less than \<120 days post-autologous or allogeneic hct for a malignancy. * platelet transfusion independent. * fully mobile on an independent basis. * for patients who have been on steroid therapy for graft versus (vs) host disease, doses of prednisone must be =\< 1.0 mg/kg/day and they must be on a tapering schedule. * english speaking. exclusion criteria: * individuals who are determined by the investigators or primary treating physician to not be physically able to participate in an independent exercise intervention such as hospitalized, wheel chair bound, unable to ambulate independently, on oxygen. * women who are pregnant will be excluded.
clinical and genetic analyzes of age-related macular degeneration

Conditions: Macular Degeneration

Summary: the purpose of this collection is to search for susceptibility genes for age-related macular degeneration (amd) alone or in combination with environmental factors and to look for genes that modulate the amd phenotype (particularly the response to treatment).


Eligibility criteria:
inclusion criteria: * age\> 55 years * diagnosis of exudative or atrophic amd in at least one eye * patient informed of the objectives of the study and having freely signed the informed consent letter * patient affiliated to a social security scheme exclusion criteria: * other retinal or choroidal lesion in the studied eye * history of severe systemic disease that could potentially hinder patient adherence to the study protocol: mental disorder, cancer, recent stroke or heart failure less than 3 months old. * known allergy to fluorescein, indocyanine green, iodine or ranibizumab
micafungin versus intravenous itraconazole as empirical antifungal therapy for febrile neutropenic patients with hematological diseases

Conditions: Febrile Neutropenia; Hematological Diseases

Summary: this study of chemotherapy occurred during the neutropenic fever in patients with antibiotic refractory fever. the investigators evaluate efficacy and safety of micafungin sodium (mycamine ® injection) 100mg dose compare to itraconazole (sporanox ® injection) 200mg as a control and this study is prospective, randomized, non-inferiority trials. therefore, this study was planned for review of the safety and efficacy in korean patients.


Eligibility criteria:
inclusion criteria: * the male and female patients over 18 years * to participate in clinical trials and voluntary written consent requirement to comply with a patient * chemotherapy with a variety of hematologic malignancies or patients undergoing stem cell transplantation * fever (temperature ≥ 38.4 ℃) showing neutropenia (absolute neutrophil count \<500/mm3) patients * combined antibiotic therapy 72 hours after the expiration of term lasts three patients exclusion criteria: * of clinical trials of breast-feeding or pregnant women of childbearing age with intent to * adapted species (candida genus, aspergillus genus) colitis caused by fungi other than the patients with fungal infection * hiv-positive patient serum * this test within 30 days of assignment to the other patients participating in clinical trials * within 72 hours of registration before the patients treated with systemic antifungal agents
prevalence of disruptive behavior in children with attention deficit hyperactivity disorder(adhd)

Conditions: Attention Deficit Hyperactivity Disorder

Summary: identification of prevalence and risk factors for disruptive behavior in children with attention deficit hyperactivity disorder and early recognition of disruptive behavior in children with adhd

adhd is asustaible pattern of inattention hyperactivity and lmpulsive behavior which can have harmful consequences for the patients social life it was called childhood hyperkinetic reaction before it is estimated that 3 to 5 percent of children show symptoms in primary school in addition to the role of genetic factor in the incidence of this mental disorder ,family imbalance and other anxiety factors play arole in the continuity of disorder.disruptive behavior with a prevalence of 1 to 10percent is a prevalent disorder in primary school similar to adhd it is 4 to 12 times more frequent among boys compared with girls . disruptive behavior characterized by aggression and violating others rights . this study is screening survey questionnaire study will be done in assuit university children hospital neuro psychiatric outpatient clinic in all children under 18 years old have adhd and exclude other psychiatric problems as :autism , depression , schizophrenia or mental retardation . investigator will take full history : personal history : name , date of birth ,age,sex ,age of onset of adhd ,type of adhd,severity of adhd ,type of disruptive behavior , history of treatment,family history : sibling have adhd,smoking of parents,drug use parents,social problems: divorce or death of parents . investigator will use dsm v criteria as adignostic criteria and screening data evaluated by adhd symptoms check list -4 (adhd -sc4 scale scores) : symptoms count scores and symptoms severity scores . all for detect outcome of the patient with adhd .

Eligibility criteria:
inclusion criteria: * all children under 18 years old with adhd at neuro pyshictric outpatient clinic exclusion criteria: * any psychiatric problems other than adhd like :autism, depression, schizophrenia or mental retardation
study of crenolanib combined with chemotherapy in flt3-mutated acute myeloid leukemia patients

Conditions: Acute Myeloid Leukemia

Summary: this is an open label, two-arm, phase i-ii trial, non-randomized. arm 1: crenolanib with standard chemotherapy (idarubicin/cytarabine, mec;mitoxantrone/etoposide/cytarabine, flag-ida: fludarabine/cytarabine/g-csf/idarubicin) arm 2: crenolanib with 5-azacitidine

for each arm: the phase i with dose-limiting toxicity (dlt) determination will use 3+3 design. phase ii total of 52 patients (26 per arm) will be treated at established phase i dose. enrollment to be simultaneous to each arm.

Eligibility criteria:
inclusion criteria: 1. confirmed diagnosis of refractory/relapsed aml or high-risk mds * arm 1: subjects must have received at least one prior therapy and a maximum of three prior therapies * arm 2: subjects must have received at least one prior therapy and a maximum of three prior therapies. no prior treatment with 5-azacitidine is allowed in this arm. 2. flt3 mutation positive (itd, tkd or other) 3. ecog ps 0-2 4. adequate liver and renal function 5. negative pregnancy test 6. extramedullary leukemia allowed except cns disease exclusion criteria: * arm 1 and 2 exclusion: 1. \<5% blasts in marrow or blood at time of screening 2. active hiv, hepatitis b or c 3. cns leukemia 4. clinically significant gvhd or organ dysfunction where chemotherapy specified by protocol cannot be given 5. patient with aml-m3 (apl) 6. pre-existing liver diseases (i.e. cirrhosis, chronic hepatitis b or c, nonalcoholic steatohepatitis, sclerosing cholangitis)
laparoscopic hernia repair with lateral umbilicus ligament for children

Conditions: Inguinal Hernia

Summary: the role of laparoscopic surgery in pediatric inguinal hernia repair is clear. laparoscopic hernia repair is especially advantageous for bilateral diseases and minimally invasive technique in children because it avoids vas injury. however, the problem of recurrent rate has not been resolved. the aim of this study was to refine the current criteria used the lateral umbilicus ligament covering the internal hernia opening region, and eliminated recurrence in laparoscopic inguinal hernia (lih) repair in children. the investigators hypothesized that the lateral umbilicus ligament covering the internal hernia opening region after the laparoscopic purse-string knot would result in lower recurrence and the same operation relative complication

the primary outcome measure was the recurrence rate after surgery, and the secondary outcome measures included degree of postoperative pain, the amount of postoperative analgesia, procedural duration, number of days to recovery normal activity, surgical complications, cosmetic results, and patient satisfaction. the outcome was recorded at the outpatient visits 10 days, 6 months, 1 year, 3 years and 5 years after the surgery. the cosmetic result was scored (unsatisfactory = 0, satisfactory = 1, good = 2, and excellent = 3) by the patients or parents, the attending nurse, and the surgeon (maximum points = 9). the patient satisfaction was scored similarly (unsatisfactory = 0, satisfactory = 1, good = 2, and excellent = 3). the long axis of the testes was measured.

Eligibility criteria:
inclusion criteria: * unilateral inguinal hernia * age between 2 years and 17 years * no history of abdominal or inguinal operations * the age range was based on the day surgery criteria of our hospital * of male patients, only those with completely descended testes were included exclusion criteria: * the bilateral hernia * the recurrence hernia

Keywords: inguinal hernia laparoscope lateral us ligament recurrence pediatric unilateral inguinal hernia