Kornimate/medical-research-clean huggingface dataset:
a phase ⅳ study of decitabine in myelodysplastic syndrome

Conditions: Myelodysplastic Syndrome

Summary: the purpose of this study is to evaluate of the safety and efficacy of decitabine treatment of myelodysplastic syndrome.

total subjects: 240, doseⅰgroup of 120 patients, doseⅱgroup of 120 patients. subjects are stratified randomize. if necessary, participants accepted best supportive therapy.

Eligibility criteria:
inclusion criteria: * age≥18; * the diagnosis of mds patients comply who2008 standards; * ipss score≥0.5; * who classification for patients rcud, rars and transfusion-dependent rcmd; * ecog ps score: 0-2; * expected survival≥3 months; * serum bilirubin≤1.5\*uln, serum alt and ast≤2.5\*uln, serum cr≤1.5\*uln; * subjects signed informed consent form in line with gcp requirements. exclusion criteria: * can not marrow biopsy; * previously diagnosed aml; * received azacitidine or decitabine treatment any time before; * being diagnosed with other malignancies in the prior 12 months; * pregnant or lactating women; * failure to control systemic fungal, bacterial or viral infection; * known or suspected allergy to decitabine; * known human immunodeficiency virus (hiv) or hepatitis b or c classes of active viral infection; * have a history of neurological or psychiatric disorders, including epilepsy or dementia; * ctcae 3 or 4 degree peripheral neuropathy; * according to the investigator's judgment, there are concomitant diseases with a serious safety hazard or affect the patients completed the study in patients; * using other experimental drugs or participating in other clinical trials in the prior one months.
the comparison of laryngeal mask airway and endotracheal tube in general anesthesia for premature neonates

Conditions: Preterm Infant; Anesthesia; Respiratory Complication

Summary: objectives: to compare the perioperative respiratory adverse events between using laryngeal mask airway and endotracheal tube in preterm neonates receiving general anesthesia for hernia surgery.

the participant patients will be randomly allocated into two groups: the laryngeal mask airway group (lma group) and endotracheal tube group (ett group). masking ventilation with sevoflurane will be used for anesthesia induction till the adequate anesthetic depth. intubation with laryngeal mask airway (lma) or endotracheal tube (ett) will be done as allocated group. after the surgery completed and the patient wakened up, the anesthesiologist will remove the lma or ett according to the clinical criteria for extubation.

Eligibility criteria:
inclusion criteria: * preterm neonates (gestational age \ 2000g at surgery exclusion criteria: * emergent surgery, infants who was intubated before surgery, long-term oxygen or mechanical ventilation dependence, severe congenital cardiopulmonary disease, lacking of birth history, combination with other major surgery, postmenstrual age \> 52 weeks at surgery

Keywords: pediatric airway management
pilot car-t cells therapy for children/young adults with cd19+ r/r leukemia/lymphoma

Conditions: B-cell Acute Lymphoblastic Leukemia; Lymphoblastic B-Cell Lymphoma

Summary: the purpose of this study is to estimate the safety and the efficacy of car- t cells immunotherapy for children/young adults with relapsed or refractory acute lymphoblastic leukemia/lymphoma.

locally manufactured second generation autologous cd19 car-t cells are used for immunotherapy. protocol treatment includes lymphodepleting conditioning (fludarabine + cyclophosphamide) followed by one car-t cells intravenous infusion with tocilizumab premedication.

Eligibility criteria:
inclusion criteria: * cd19+ relapsed or refractory lymphoblastic leukemia/lymphoma; * karnofsky or lansky performance scale greater or equal to 70; * t-cells count in peripheral blood \>150 cells/µl; * written informed consent. exclusion criteria: * primary immunodeficiencies or genetic syndromes; * neurologic diseases; * autoimmune diseases or polyallergie; * transfusion of donor lymphocyte less than 6 week before car-t cells infusion; * gvhd grade 2-4; * uncontrolled systemic infection; * hypoxia (sp02\<90%) * severe hepatic dysfunction: alt or ast \>=3x upper limit of normal for age; * renal dysfunction: serum creatinine level \>=3x upper limit of normal for age; * positive serology for human immunodeficiency virus (hiv), active hepatite c or b; * pregnancy.

Keywords: immunotherapy car-t cells cd19
auxiliary diagnosis of liver nodules using cfdna whole-genome signatures

Conditions: Focal Liver Lesions

Summary: as a prospective, multi-center study, guider will recruit 400 liver nodules participants from different provinces and regions across china. except for cfdna signatures, serum biomarkers, histopathological biopsy and enhanced mri will also be performed. the sensitivity and specificity of the cfdna signature based-model in liver nodules diagnosing will be evaluated.

patients with liver nodules will be recruited for 1 year. peripheral blood samples of all participants will be collected after being informed about the study and potential risks. cfdna extraction, library construction, and whole genome sequencing will be performed. a machine learning method will be implemented for cfdna signatures-based model construction at the end of the study. sensitivity and specificity will be used to evaluate the performance of cfdna signatures-based model in liver nodules diagnosis.

Eligibility criteria:
inclusion criteria: * eighteen years or elder； * participants underwent enhanced mri for the evaluation of liver nodules ≤5 cm； * participants whose platelet count ≥ 50×109/l, prothrombin activity (pta) ≥ 60%； * participants who are willing and able to perform hepatectomy or tissure biopsy. exclusion criteria: * participants with different enhancement mode liver nodules that detected by enhanced mri and without ceus confirmation； * diagnosis of malignant tumors before recruitment； * anti-tumor therapy before recruitment ； * hiv infection； * pregnancy； * allogenic blood transfusion or cell therapy within 14 days before peripheral blood samples collection; * participants with hepatic encephalopathy, hemangioma, ascites, gastrointestinal bleeding, jaundice, liver failure, congestive heart failure, or any other serious diseases that causing organ damage. * participants with any other factors that may leading to termination of the study.

Keywords: hepatocellular carcinoma liver nodules auxiliary diagnosis liquid biopsy peripheral blood cfdna
a comparison study between protopic (tacrolimus) ointment and elidel (pimecrolimus) cream in treating subjects with atopic dermatitis

Conditions: Dermatitis, Atopic

Summary: a study to compare efficacy of protopic ointment to that of elidel cream in treating patients with atopic dermatitis


Eligibility criteria:
inclusion criteria: * diagnosis of atopic dermatitis rated at least mild using the investigator's global atopic dermatitis assessment involving a minimum of 5% of the body surface area * negative pregnancy test and agrees to practice effective birth control during the study exclusion criteria: * skin disorder other than atopic dermatitis in the areas to be treated * extensive scarring or pigmented lesions in the areas to be treated that would interfere with rating of efficacy parameters * clinically infected atopic dermatitis at baseline * likely to require systemic corticosteroids; or likely to require intranasal or inhaled corticosteroids for an off-label indication or at higher doses than the maximum labeled dosing for the drug * known hypersensitivity to macrolides or any excipient of either study medication * chronic condition which is either not stable or not well controlled * pregnant or breast feeding an infant

Keywords: atopic dermatitis protopic elidel
genetics of progressive multifocal leukoencephalopathy and acquired immunodeficiency syndrome

Conditions: PML; AIDS

Summary: this study will identify genetic factors associated with the development of progressive multifocal leukoencephalopathy (pml) in patients with acquired immunodeficiency syndrome (aids). pml is a life-threatening infection of the brain that affects about 5 percent of untreated patients with aids. its symptoms include mental deterioration, vision loss, speech disturbances, ataxia (inability to coordinate movements), paralysis, and coma. pml is caused by a polyomavirus called the jc virus. it is estimated that up to 80 percent of the human population has been exposed to the jc virus, but the disease is very rare. the virus only becomes active in people who have compromised immune systems, such as those undergoing immune suppressive chemotherapy for cancer and those with damaged immune systems due to hiv. patients who have participated in the multicenter aids cohort study may be eligible for this study, as well as healthy normal volunteers who will serve as controls. the study will review clinical information from patients and analyze genetic factors from both patients and control subjects to investigate genes associated with aids and jc virus infection.

the purpose of this study is to identify host genetic factors that contribute to the development of progressive multifocal leukoencephalopathy (pml) associated with jc virus. jc virus is one of many opportunistic infections that arise in aids patients. jc virus is widely distributed in the general population, with estimates of population exposure ranging from 30-80%. jc virus remains latent in the host, and in profoundly immunosuppressed patients, jc virus can cause pml, a fatal disease associated with neurotropic jc virus that lytically infects oligodendrocytes. in untreated aids populations, the frequency of pml has been estimated at roughly 5%. this study will identify host genetic factors that may contribute to the development of pml in the aids population.

Eligibility criteria:
* no available subjects will be excluded.

Keywords: jc virus opportunistic infection single nucleotide polymorphism genotype sequencing
evaluation of intermittent triple therapies in real life

Conditions: HIV Infections

Summary: the strategy of intermittent triple therapy for people living with hiv was validated in france following the randomized clinical trial quatuor. there is little data in real life, as shown in the meta-analysis of parienti jj et al. currently this strategy is proposed by some teams in france, but is not recommended internationally. the research hypothesis is that intermittent treatment is an effective and safe option in a therapeutic lightening strategy in people living with hiv people living with hiv adults followed in strasbourg who have benefited from intermittent treatment the expected results will consist of an improvement in knowledge on the efficacy and tolerance of this therapeutic strategy.


Eligibility criteria:
inclusion criteria: * adult subject (≥ 18 years old) * living with hiv monitored at the trait d'union/infectious diseases department in strasbourg * having benefited from intermittent triple therapy between 01/01/2017 and 31/01/2024 exclusion criteria: * subject (and/or their legal representative if applicable) having expressed their opposition to the reuse of their data for scientific research purposes.

Keywords: hiv infections intermittent triple therapy
a comparison of the efficacy and safety of topiramate versus placebo in preventing migraine headaches in children

Conditions: Migraine

Summary: the purpose of this study is to assess the safety and efficacy of topiramate as compared to placebo in preventing migraines in children.

pediatric migraine headache is a common cause of severe recurring headaches in children, especially children between the ages of 5 and 15 years. these headaches can be disabling and tend to interfere with a child's daily activities, such as going to school or playing with friends. because pediatric migraine children tend to be misdiagnosed, they are often not treated effectively. topiramate, an anti-seizure medication, has been shown to prevent migraines in adults, and it has been approved to treat seizures in children as young as 2 years of age as add-on treatment (used with another drug) and also can be used alone (monotherapy) in children as young as 10 years old. since topiramate has already been studied in children, information about its safety in children is available. in this study, children with migraine headaches will be identified. it is not necessary for the child to have the migraine aura (having blurry vision; seeing flashing lights) to be included in this study. this is a randomized, double-blind, placebo-controlled study of topiramate (or placebo) given for 4 to 5 months. an optional 3-month open-label extension (topiramate only; no placebo) will follow. the objective of the study is to demonstrate that topiramate is effective and safe when used to prevent migraine headaches (with or without aura) in children. safety will be assessed throughout the study. topiramate sprinkle capsules (or placebo), starting at 15 milligrams per day for 1st week; increased to 30 milligrams per day for week 2; increased to 50 milligrams (in tablets) per day in week 3, then adjusted as needed to 2 to 3 milligrams/kilogram/day for the rest of study (140 days total).

Eligibility criteria:
inclusion criteria: * children who have had several attacks of headaches that meet the international headache society classification of pediatric migraine with or without aura (for example, headache lasts up to 48 hours, has a throbbing quality, is accompanied by nausea or sensitivity to light, is made worse by physical activity) * average of 3 to 10 migraine days per month for previous 3 months * weighs more than 20 kilograms (44 pounds) * able to swallow a tablet whole (without crushing it) exclusion criteria: * took topiramate previously to prevent migraines but it was not effective * had to stop taking topiramate because of side effects * presence of cluster headaches, migraine aura without headache * had taken any medications for migraine prevention within 2 weeks before study start * presence of active liver disease or abnormal kidney function

Keywords: pediatric migraine migraine headache migraine prophylaxis migraine prevention migraine
a study to evaluate the safety, tolerability, and immunogenicity of v114 followed by pneumovax™23 in adults infected with human immunodeficiency virus (hiv) (v114-018)

Conditions: Pneumococcal Infections

Summary: this study is designed to 1) describe the safety, tolerability, and immunogenicity of v114 and prevnar 13™ in pneumococcal vaccine-naïve adults infected with hiv and to 2) describe the safety, tolerability, and immunogenicity of pneumovax™23 when administered 8 weeks after receipt of either v114 or prevnar 13™.


Eligibility criteria:
inclusion criteria: * male or female infected with human immunodeficiency virus (hiv) and cluster of differentiation 4+ (cd4+) cell count ≥50 cells/µl and plasma hiv ribonucleic acid (rna) \<50,000 copies/ml * receiving combination anti-retroviral therapy (art) for at least 6 weeks before enrollment with no intention of changing therapy for 3 months after randomization * female participant: not pregnant, not breastfeeding and 1) not of childbearing potential, or 2) of childbearing potential and agrees to practice contraception through 6 weeks after administration of study vaccine. exclusion criteria: * history of opportunistic infections within 12 months before the first study vaccination * history of non-infectious acquired immune deficiency syndrome-related illness such as kaposi's sarcoma, wasting syndrome, or hiv-associated nephropathy * history of invasive pneumococcal disease * known hypersensitivity to any vaccine component * known or suspected congenital immunodeficiency, functional or anatomic asplenia, or history of autoimmune disease * coagulation disorder contraindicating intramuscular vaccination * history of malignancy ≤5 years before enrollment, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer * female participant: positive urine or serum pregnancy test * prior administration of any pneumococcal vaccine * received systemic corticosteroids for ≥14 consecutive days and have not completed within 30 days of enrollment * received immunosuppressive therapy * received a blood transfusion or blood products within 6 months of enrollment * participated in another clinical study of an investigational product within 2 months of enrollment * current user of recreational or illicit drugs or recent history of drug or alcohol abuse or dependence.

Keywords: conjugate pneumococcal vaccine, 15-valent, 22f, 33f
yoga cancer rehabilitation study: a randomized trial of adaptive yoga for older cancer survivors

Conditions: Neoplasms

Summary: with advances in the detection and treatment of cancer, there are now 14 million cancer survivors in the u.s., 500,000 of whom are treated in the veterans health administration. the mental and physical health consequences of cancer and its treatment may affect a veteran's functioning and re-integration back into family, work, and daily life. recent studies suggest that yoga may be an effective intervention for improving both the physical and mental health of individuals after cancer, although this has not been studied in veterans. this study has three components: (1) determine factors that increase participation in yoga by veterans using individual interviews and focus group; (2) create a yoga protocol for veterans adapted from an existing empirically supported treatment, akin to a phase 1 clinical trial for safety and tolerability; (3) evaluate the efficacy of yoga for improving fatigue, insomnia, anxiety, and depression after treatment for colorectal cancer, akin to a phase 2 trial with randomization.

with a 1 and 2 lifetime risk of diagnosis, cancer is a highly prevalent disease. cancer and its treatment are associated with long term mental and physical side effects that impair physical, vocational, and social role functioning. in order to provide excellent care for veterans, rehabilitative strategies to improve mental and physical health after cancer treatment need empirical study. the objective of the proposed pilot project is to create a veterans' yoga rehabilitation program for cancer survivors who receive care in the veterans health administration, that is based on an existing evidence based protocol which is systemically adapted, marketed, and tested in a veteran population, with 3 aims: aim 1: enhancing acceptability to determine factors that will increase participation in yoga in veterans after treatment for cancer, who are primarily male and older than age 60. aim 2: adapting to veterans to create a yoga protocol by adapting an empirically supported yoga protocol to the needs of veterans. aim 3: evaluating efficacy to evaluate the efficacy of the yoga protocol for improving health related quality of life in four domains, and, to determine if efficacy varies as a function of patient age or pre-existing post traumatic stress disorder. the long term goal is to develop an evidence based mind-body yoga intervention to support healing and restore function in veterans health administration patients for use after treatment for cancer.

Eligibility criteria:
inclusion criteria: * cancer treated in the past 3 years exclusion criteria: * dementia * psychotic disorder * in hospice care

Keywords: neoplasms
benefit of follicular flushing during oocyte retrieval for poor responder patient in an assisted reproductive technology program

Conditions: Infertility, Female; Ovarian Insufficiency

Summary: the object of this study is to determine the benefit of follicular flushing with a double channel needle in a poor responder population for a maximum number of oocytes to be retrieved. the investigators compare two methods of oocyte retrieval with or without flushing. 220 patients undergoing an in vitro fertilization (ivf) or intracytoplasmic sperm injection (icsi) have to be included. all patients with less than 5 follicles of 14 mm and more the day of ovulation induction will be included, following a randomized protocol in two groups, group a: oocyte retrieval is performed with a single lumen aspiration needle 17g. group b: oocyte retrieval is performed with a double lumen aspiration needle 17g. all follicles are flushed with flushing solution in addition to direct aspiration of the follicular fluid, 20cc of flushing medium is provided for all the procedure and flushing medium is collected separately from direct fluid aspiration in order to follow up each oocyte one by one. first criterion of our comparison is the number of oocyte retrieved. second criteria are: oocyte quality, fertilization rate, number and quality of embryos obtained, clinical pregnancy rate. in group b the investigators will compare two subgroups: oocytes collected in flush medium and oocytes from direct follicle fluid. then the investigators will know the capability of oocyte collected after follicular flushing to be fertilized and to increase the success chance of pregnancy for poor responder patients.


Eligibility criteria:
inclusion criteria: * patients undergoing an ivf or icsi treatment * long agonist, antagonist or short stimulations protocols * less than 5 follicles of 14mm or more day of hcg * major patients aged under 43 years * patient within a couple married or can prove a married life of over 2 years exclusion criteria: * all the cons indication to the oocyte retrieval * oocyte donor * couple supported viral loop * patient does not speak french or unable to give informed consent * patients major protected * patients with biopsy performed on weekends are also excluded due to unavailability of adequate personnel and equipment * absence of follicles
electrical stimulation in traumatic brain injury (tbi) induced aphasia

Conditions: Aphasia; TBI (Traumatic Brain Injury); tDCS

Summary: the aim of this study is to investigate whether a tdcs-accompanied intensive naming therapy leads to a performance improvement in patients with chronic aphasia induced by a moderate tbi


Eligibility criteria:
inclusion criteria: * aphasia assessed by aachener aphasie test (aat) \> 6 month after moderate tbi * age: 18 - 80 years * right handedness exclusion criteria: * dementia or other neurological diseases * history of severe alcoholism or use of drugs * severe psychiatric disorders such as depression, psychosis (if not in remission) * severe untreated medical problems such as cancer