Kornimate/medical-research-clean huggingface dataset:
comparing the prognosis of patients with hcc and pvtt treated with surgery versus locoregional therapy.

Conditions: Hepatocellular Carcinoma

Summary: hepatocellular carcinoma is prone to invade the portal vein and form portal vein thrombosis, and patients in this period are directly included in the advanced stages, i.e. barcelona clinical liver cancer stage c. for the treatment of pvtt, there are differences between eastern and western guidelines, with systemic drugs being the standard of care in western countries, while surgical treatment is often actively practiced in the asia-pacific region. more research is needed to explore the differences between these two approaches.

hepatocellular carcinoma is prone to invade the portal vein and form portal vein thrombosis, and patients in this period are directly included in the advanced stages, i.e. barcelona clinical liver cancer stage c. for the treatment of pvtt, there are differences between eastern and western guidelines, with systemic drugs being the standard of care in western countries, while surgical treatment is often actively practiced in the asia-pacific region. in recent years, breakthroughs have been made in the treatment of advanced hcc, and systemic drug combinations such as pd-1 inhibitors combined with targeted therapies, and local area therapy combined with systemic therapy have shown excellent anti-tumor effects. postoperative adjuvant therapy is also advancing, and the combination of adjuvant systemic medications for patients after pvtt has also been effective in reducing postoperative recurrence. which approach is better for pvtt patients needs to be explored in depth.

Eligibility criteria:
inclusion criteria: * aged 18-75 years * pathological type is hcc, and with pvtt * no extrahepatic hcc * eastern cooperative oncology group (ecog) performing status of 0-1 and child-pugh grade a for the liver resection group * ecog performing status of 0-2 and child-pugh grade a-b for the locoregional-based group * adequate hematologic and organ function exclusion criteria: * any history of other malignant tumors or recurrent hcc * any acute active infectious diseases, active or history of autoimmune disease, or immune deficiency * any persistent serious liver resection or locoregional therapy-related complications * esophageal and/or gastric variceal bleeding within 6 months * inability or refusal to comply with the treatment and monitoring * participation in other clinical trials

Keywords: hepatocellular carcinoma adjuvant therapy overall survival liver resection combined therapy
lutrepulse hypogonadotropic hypogonadism

Conditions: Primary Amenorrhea With Hypogonadotropic Hypogonadism

Summary: to compare the ovulation rate in women with primary amenorrhea with hypogonadotropic hypogonadism following pulsatile gonadotropin-releasing hormone (gnrh) treatment using the omnipod pump versus placebo


Eligibility criteria:
inclusion criteria: * women 18-40 years old * body mass index (bmi) between 18 and 38 kg/m2 * clinical history or recently diagnosed with primary amenorrhea with hypogonadotropic hypogonadism * hormonal values in a centrally analyzed fasting blood sample: fsh \<5 iu/l and mean lh \<5 iu/l * desire to become pregnant * discontinued estrogen-progesterone replacement therapy at least 1 month before screening * negative progestin challenge test performed during screening * pap smear within 24 months of the initial visit * normal or stable ct scan or mri scan of the hypothalamic pituitary region * prolactin and thyroid-stimulating hormone (tsh) within normal clinical laboratory limits * male partner with normal semen analysis, including volume, liquefaction time, sperm count, and motility, according to the local laboratory normal criteria, within the past year * normal transvaginal ultrasound at screening with respect to uterus and adnexa (presence of both ovaries and tubes, without evidence of clinically significant abnormality) and with normal uterine cavity and normal cervix * tube patency on saline tubal perfusion, hysterosalpingography or laparoscopy on file within the past 2 years exclusion criteria: * any medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the drug * a history of, or currently diagnosed with clinically important cardiovascular, pulmonary (e.g. serious corticosteroid-dependent asthma), gastrointestinal, hepatic, metabolic, renal, endocrinological (e.g. insulin dependent diabetes mellitus), or neurological (e.g. epilepsy, serious migraine, central nervous system (cns) lesions (in cases where hypogonadotropic hypogonadism is secondary to a cns lesion or its treatment) abnormality * a history of adrenal or uncontrolled thyroid disorders, or hyperprolactinemia * prior treatment cycle with gonadotropins or gnrh within the last 2 months * known allergy to study drug or its components * infection with human immunodeficiency virus (hiv), hepatitis b or hepatitis c * ovarian enlargement or cyst of unknown etiology * abnormal gynecological bleeding of undetermined origin * previous or current hormone-dependent tumor * known active substance abuse * planning to undergo in vitro fertilization procedure in the course of a study treatment cycle * currently undergoing treatment with gonadotropin hormones (fsh and lh), psychotropic medication, sex hormones, or any other medication known to interfere with normal reproductive function or that can affect gnrh secretion (e.g. neuroleptics, dopamine antagonists, spironolactone, levodopa, phenothiazine, digoxin) * ongoing pregnancy or lactation
changes in cerebral oxygenation related to intraoperative position changes

Conditions: Scoliosis Patients

Summary: this is a prospective, observational study. this study will assess the effect of temporary changes in body position (supine, head of bed elevated 30 degrees, head of bed elevated 60 degrees) in anesthetized patients. tissue oxygenation will be assessed non-invasively using near infrared spectroscopy (nirs) by a device that is used in our operating rooms and the icu setting to assess cerebral and tissue oxygenation.


Eligibility criteria:
inclusion criteria: * patients 10-21 years of age undergoing posterior spinal fusion, requiring neurophysiologic monitoring and an arterial cannula exclusion criteria: * patients in whom an arterial cannula is not indicated for the surgical procedure * patients with comorbid conditions that may impact cerebral blood flow, cerebral perfusion or place them at risk for cerebral hypoperfusion * patients in whom an invasive arterial cannula cannot be placed
a phase i study of inc280 in japanese patients with advanced solid tumors

Conditions: Advanced Solid Tumor

Summary: inc280 will be administered to japanese patients with advanced soid tumors whose disease has progressed despite standard therapy or for whom no standard therapy exists. the trial will assess the safety and tolerability and determine the maximum tolerated dose (mtd) on inc280


Eligibility criteria:
inclusion criteria: * advanced solid tumors that are refractory to currently available therapies or for which no effective treatment is available. * eastern cooperative oncology group (ecog) performance status ≤ 2 * good organ (hepatic, kidney, bm) function at screening/baseline visit. exclusion criteria: * symptomatic cns metastases that are neurologically unstable or requiring increasing doses of steroids to control cns disease. * impairment of gastrointestinal (gi) function or gi disease that may significantly alter the absorption of inc280. * undergone a bone marrow or solid organ transplant. * women who are pregnant or breast feeding. other protocol-defined inclusion/exclusion criteria may apply

Keywords: c-met advanced solid tumor
opv as potential protection against covid-19

Conditions: Poliovirus Vaccine, Oral; COVID; Mortality; Morbidity; Non-Specific Effects of Vaccines

Summary: since the 1960s, studies have shown that oral polio vaccine (opv) may have beneficial non-specific effects, reducing morbidity and mortality from other infections than polio. such beneficial non-specific effect have been observed for other live vaccines, including measles, smallpox and bcg vaccine. for bcg, the vaccine for which the mechanism has been studied the most, the effects appear to be mediated through the innate immune system. the covid-19 pandemic caused by the novel coronavirus sars-cov-2 has now caused over 7.1 million cases and \>400,000 deaths worldwide. as everywhere else, it is anticipated that in africa the older part of the population will be at risk of severe covid-19. opv is widely used in africa, but for children. both polio and coronavirus are positive-strand rna viruses, therefore it is likely that they may induce and be affected by common innate immune mechanisms. in a randomised trial at the bandim health project in guinea-bissau, the investigators will assess the effect of providing opv vs no vaccine to 3400 persons above 50 years of age. the trial will have the power to test the hypothesis that opv reduces the combined risk of morbidity admission or death (composite outcome) by at least 28% over the subsequent 6 months.


Eligibility criteria:
inclusion criteria: * living in a household which has had a census visit conducted after 1 january in 2017. age above 50. exclusion criteria: * previous adverse events to opv; previous documented covid-19; acute severe infection.
safety, tolerability, efficacy and pharmacokinetics of copanlisib in pediatric patients

Conditions: Relapsed or Refractory Solid Tumors or Lymphoma in Children; Neuroblastoma; Osteosarcoma; Rhabdomyosarcoma; Ewing Sarcoma

Summary: this study is designed to investigate whether the use of copanlisib is safe, feasible and beneficial to pediatric patients with solid solid tumors or lymphoma that are recurrent or refractory to standard therapy.


Eligibility criteria:
inclusion criteria: * signed informed consent form by patients and/or patients' parents/legal guardians and age appropriate assent form by the patients obtained before any study specific procedure * male or female patients from 6 months to ≤ 21 years old at the time of study enrollment * confirmation of diagnosis: * phase i: patients must have histologic verification of a solid tumor or lymphoma malignancy at diagnosis, with measurable or evaluable disease, for which there is no standard curative anti-cancer treatment or treatment is no longer effective and must have received ≥ 1 prior line of therapy. * phase ii: patients must have histologically verified tumor at initial diagnosis and radiologically or histologically confirmed status at inclusion as indicated in the following: neuroblastoma, osteosarcoma, rhabdomyosarcoma or ewing sarcoma. * patients with solid tumors must have measurable disease (evaluable disease is acceptable for neuroblastoma and ewing sarcoma). tumor assessment will be done via computed tomography (ct), magnetic resonance imaging (mri) or positron emission tomography-computed tomography (pet-ct). tumor lesions situated in a previously irradiated area, or in an area subjected to other loco-regional therapy, may be considered measurable if there has been demonstrated progression in the lesion. bone scans (if clinically indicated) should be obtained within ≤ 4 weeks prior to the start of treatment. * performance level: lansky ≥ 50% for patients ≤ 16 years of age and karnofsky ≥ 50% for patients \> 16 years of age. * adequate bone marrow, renal and liver function. exclusion criteria: * active or uncontrolled infection (national cancer institute (nci)-ctcae grade ≥ 2). * history or concurrent condition of interstitial lung disease of any severity and/or severely impaired lung function (as judged by the investigator). * diabetes mellitus. * uncontrolled arterial hypertension despite optimal medical management (per institutional guidelines). * patients with central nervous system (cns) malignancies.

Keywords: phase i: relapsed or refractory solid tumors or lymphoma phase ii: relapsed or refractory solid tumors (neuroblastoma, osteosarcoma, rhabdomyosarcoma or ewing sarcoma)
a study to evaluate symptomatic remission in schizophrenia with long acting risperidone microspheres

Conditions: Schizophrenia

Summary: the purpose of this study is to evaluate symptomatic remission rate in patients with schizophrenia using long acting risperidone microspheres

although most of korean schizophrenic patients currently take oral antipsychotic medications, it is estimated that up to 75% of them have difficulty adhering to daily oral regimen. long-acting injectable formulation may eliminate this need for daily medication. this is a prospective, open-label, multicenter study to determine the long-term efficacy, especially symptomatic remission rate of long-acting risperidone microspheres administrered in the muscle at 2 week intervals in patients with schizophrenia. the patients will receive intramuscular injections either 25, 37.5, 50 mg equivalent of risperidone at every 2 weeks for 1 year

Eligibility criteria:
inclusion criteria: * subjects with schizophrenia or schizoaffective disorder - subjects who have experienced relapse or re-admission previously - subject and/or his/her relative, guardian or legal representative who has signed the informed consent form exclusion criteria: * first antipsychotic treatment ever - on clozapine during the last 3 months - serious unstable medical condition, including recent and present clinically relevant laboratory abnormalities - subjects that are previously on concomitant use of risperdal consta within 60 days prior to entry - previous sensitivity history to risperidone - history or current symptoms of tardive dyskinesia - history of neuroleptic malignant syndrome - pregnant or breast-feeding female - female patient of childbearing age without adequate contraception (adequate contraception includes: abstinence, oral contraceptive, intrauterine devices, barrier method (diaphragm or condom) plus spermicide - norplant tm or depo-provera tm. a female patient of childbearing potential must have an adequate contraception and a negative urine pregnancy test at every visit)

Keywords: schizophrenia risperidone intramuscular injection, long-acting risperidone
study to evaluate the safety, pharmacokinetics and efficacy of recombinant factor viii fc fusion protein (rfviiifc) in previously treated subjects with severe hemophilia a

Conditions: Severe Hemophilia A

Summary: the primary objectives of this study are: to evaluate the safety and tolerability of rfviiifc administered as a prophylaxis (arm 1), weekly (arm 2), on-demand (arm 3), and surgical treatment regimen; to evaluate the efficacy of the rfviiifc tailored prophylaxis regimen (arm 1); to evaluate the efficacy of rfviiifc administered as an on-demand (arm 3) and surgical treatment regimen. the secondary objectives of this study are: to characterize the pk profile of rfviiifc and compare the pk of rfviiifc with the currently marketed product, advate®; to characterize the range of dose and schedules required to adequately prevent bleeding in a prophylaxis regimen, maintain hemostasis in a surgical setting, or to treat bleeding episodes in an on-demand, weekly treatment, or prophylaxis setting.

participants are assigned to one of three treatment regimens: 1) a tailored prophylaxis regimen, 2) a weekly dosing regimen, or 3) an on-demand regimen. treatment continued for 28 (±2) to 52 (±2) weeks. pk assessments for all participants are conducted on varying schedules, according to participants' group assignments. additionally, two subgroups are defined. one subgroup of participants undergo pk profiling with a single dose of the comparator advate®. a second subgroup consists of participants from any of the treatment arms that required surgery during the study. depending upon country location, participants might have the option of continuing treatment within study 8ha01ext (nct01454739).

Eligibility criteria:
inclusion criteria: * male, ≥12 years of age with weight at least 40 kg * diagnosed with severe hemophilia a, defined as \<1 iu/dl (\<1%) endogenous factor viii) * history of at least 150 documented prior exposure days to any factor viii product * platelet count ≥100,000 cells/μl exclusion criteria: * history of factor viii inhibitors * kidney and liver dysfunction * diagnosed with other coagulation disorder(s) in addition to hemophilia a * prior history of hypersensitivity or anaphylaxis associated with any fviii or iv immunoglobulin administration
efficacy of cognitive behavioral therapy in treatment of adults with attention deficit hyperactivity disorder

Conditions: Attention Deficit Hyperactivity Disorder

Summary: the purpose of the project is to evaluate the efficacy of cognitive behavioral therapy (cbt) for adults with attention deficit hyperactivity disorder (adhd) with and without stimulant medication and compare it to medication alone. subjects will be randomly assigned to stimulant medication only, cbt only and combined cbt and stimulant medication group. patients will be evaluated at baseline, following mediation optimization (for medicated groups), following 12 months of treatment, after 3 months of follow up, and after 6 months of follow up. the investigators hypothesize that the combined group will have the best outcome at all evaluation points. adhd in adults is associated with significant morbidity and impaired academic, occupational, social, and emotional functioning. developing optimal treatment approaches for this population is key in improving their functioning.


Eligibility criteria:
inclusion criteria: * diagnostic and statistical manual of mental disorders, 4th edition, text revision (dsm-iv-tr) criteria for adult adhd of any of three subtypes via conners' adult adhd diagnostic interview for the dsm-iv (caar-d) and clinician's assessment; * barkley childhood and current symptom of adhd (1998) completed by self and informants (parents or siblings). required cut off's on these scales are scores 1.5 standard deviation above relevant gender and age norms; * conners' adult adhd rating scale (1999). required cut off's on these scales are scores 1.5 standard deviation above relevant gender and age norms; * between 18 and 60 years old * be able to give informed consent and comply with study procedures; * i.q. of 80 or above on wechsler adult intelligence scale, 3rd edition (wais-iii) subtests of three verbal and three nonverbal subtests * adequate command of english to be able to participate in cbt group. exclusion criteria: * psychotic symptoms, past or current * current psychiatric comorbidity, e.g. bipolar disorder, depression, suicidality, current substance use disorder (must be free of substance abuse for 6 months) * medical condition that preclude use of the stimulant medication, e.g. hypertension, cardiac disease, tourette's syndrome, etc. * organic mental disorders or other significant neurological disorders, e.g. epilepsy, head injury, chorea, multiple sclerosis, deafness, blindness.

Keywords: cognitive behavioral therapy stimulant medication efficacy symptoms functional outcomes
the effect of low dose aspirin in increasing the chance of pregnancy

Conditions: Infertility

Summary: it has been reported that low-dose aspirin and heparin would lead to an increased pregnancy rate in patients undergoing ivf-et. low-dose aspirin may improve uterine and ovarian perfusion and that aspirin might enhance endometrial receptivity and ovarian responsiveness as well, which could result in better implantation and pregnancy rates after ivf or icsi treatment. this study assesses potential effects of low-dose aspirin (100 mg daily) on pregnancy rate following frozen embryo transfer.

in the present randomized double-blind prospective study, the patients will be randomly assigned to the study and control groups. with the onset of endometrial preparation and estrogen treatment, the study group will receive 100 mg of oral aspirin and the control group will be given placebo. when endometrial thickness will be found between 8-14 mm, therapy with progesterone (100 mg im daily) will be started and embryo transfer will be performed 48 to 72 hours later. doppler ultrasonography also is done to calculate resistive index (ri) and pulsatility index (pi), the day after progesterone administration. βhcg will be assessed 14 days after et. if a pregnancy will be achieved, the patients in study and control groups will be instructed to continue the aspirin or placebo through 5 weeks and if the pregnancy test result will be negative, the treatment with aspirin or placebo will be stopped. the patients will be followed until 20 weeks of gestation and the results of treatment cycle will be compared in two groups.

Eligibility criteria:
inclusion criteria: * patients with "long or antagonist" protocol * women who did not achieve a pregnancy following a fresh embryo transfer or women whom their embryos had not been transferred due to ohss * the women who had frozen embryos available for another transfer no contraindications for aspirin exclusion criteria: * the patients with history of recurrent abortion

Keywords: low dose aspirin endometrial thickness pregnancy rate icsi ivf embryo transfer
expanded access to gallium-68 psma-11 pet in patients with biochemical recurrent prostate cancer

Conditions: Prostate Adenocarcinoma

Summary: this is an expanded access program using 68ga psma-hbed-cc (68ga-psma-11). the primary goal of this expanded access program is to make 68ga psma-11 pet/ct imaging available to patients.

imaging and staging of prostate cancer is critical for surgical and treatment planning. gallium-68 labeled hbed-cc psma (more commonly called 68ga-psma-11) has recently been approved by the fda for clinical use in a formulation utilized at the university of california in los angeles ucla) and san francisco (ucsf). the production process for 68ga-psma-11 at the university of michigan (um) is different and not fda approved. this expanded access program was established to allow a continued use of 68ga-psma-11 produced at the university of michigan for clinical management for prostate cancer at the university of michigan.

Eligibility criteria:
inclusion criteria: * histopathological proven prostate adenocarcinoma * elevated psa after initial therapy: post radical prostatectomy (rp) - aua recommendation. psa greater than 0.2 ng/ml measured more than 6 weeks after rp and confirmatory persistent psa greater than 0.2 ng/ml * elevated psa after initial therapy: post radiation therapy or post focal therapy of prostate gland. nadir + greater than or equal to 2 ng/ml rise in psa * ability to understand a written informed consent document and the willingness to sign it exclusion criteria: * current investigational therapy for prostate cancer * unable to lie flat, still, or tolerate a pet/ct scan

Keywords: prostate cancer