Kornimate/medical-research-clean huggingface dataset:
tace and sorafenib for advanced hepatocellular carcinoma (hcc)

Conditions: Hepatocellular Carcinoma

Summary: for patients with advanced hcc not suitable for resection or liver transplantation but without extrahepatic manifestations, local therapy with tace is regarded as standard treatment. the present study is planned to evaluate the combination of tace and sorafenib. a combination of tace with a multitarget inhibitor like sorafenib may further improve the outcome of patients with hcc.


Eligibility criteria:
inclusion criteria: * with histologically confirmed hcc not suitable for resection or liver transplantation * patients with measurable disease according to recist * performance status ecog 0-2 * normal organ and bone marrow function (defined) * women of childbearing potential must have performed a negative serum pregnancy test * male or female patients must use an approved contraceptive method during treatment and for 3 months after end of treatment after the end of treatment with study medication * written informed consent exclusion criteria: * patient is eligible for liver resection or liver transplantation * extrahepatic tumor manifestation * thrombosis of the portal vein * \> 8 points according to child pugh classification * prior tace or rfta or any other local ablative treatment * prior systemic anticancer chemotherapy or radiotherapy for hcc * total bilirubin \> 4.5 mg/dl * life expectancy of less than 12 weeks * esophageal varices grade iii without prophylactic band ligation * cardiac diseases (defined) * uncontrolled hypertension * known or suspected hyperthyroid state * known brain metastasis * patients with seizure disorder requiring medication * history of organ allograft * active clinically serious infections \> ctcae grade 2 * thrombotic or embolic events * hemorrhage/bleeding event (defined) * acute variceal bleeding * therapeutic anticoagulation with vitamin k antagonists (defined) * known or suspected allergies to sorafenib, doxorubicin or lipiodol or any agent given in the course of this trial * contraindications to the use of sorafenib, doxorubicin or lipiodol * previous cancer distinct in primary site or histology from hcc (defined) * substance abuse * participation in another clinical trial with any investigational study drug * lactating women * incapability to give valid informed consent

Keywords: tace hepatocellular carcinoma
long term immunogenicity of quadrivalent human papillomavirus vaccine (gardasil®)in hiv-infected adolescents and young adults

Conditions: HPV; HIV

Summary: infection with human immunodeficiency virus (hiv) is an important risk factor for hpv infection and the development of hpv-associated lesions in female and male anogenital tract. data on safety and immunogenicity of quadrivalent human papillomavirus vaccine in hiv-infected population are few. the present study is a non-randomized controlled clinical trial with the primary objective to determine safety ad immunogenicity of quadrivalent human papillomavirus vaccine (gardasil®) in hiv-infected female and male adolescents and young adults.


Eligibility criteria:
inclusion criteria: * for both hiv-infected and healthy subjects: * subjects aged 13-27 years, females and males * written informed consent from parent or guardian if applicable (age\<18 years) * for hiv-infected subjects: * hiv-positive * asymptomatic subjects (generalized lymphadenopathy is accepted) * lymphocyte cd4+ count \> or equal to 350 cells/mm3 * for subjects receiving haart: * good compliance to therapy * at least two suppressed viral loads hiv-rna (\<37copies/ml9 during 6 months prior to enrollment. exclusion criteria: * for female subjects (both hiv-infected and healthy) * pregnancy or breastfeeding * total hysterectomy. participants who have undergone partial hysterectomy and have a cervix are not excluded. * for both females and males (hiv-infected and healthy): * prior vaccination with quadrivalent hpv vaccine gardasil before study entry. * history of severe allergic reaction after previous vaccination or hypersensitivity to any vaccine component. * any serious chronic or progressive disease (other than hiv) according to the judgment of the investigator: * acute infection requiring therapy or fever at time of enrollment * chronic autoimmune or oncologic disease receiving chemotherapy * concomitant therapies (other than haart): * chronic therapy (for more than 14 days consecutively) with immunosuppressive or immunomodulating agents or chemotherapy during the 6 months prior to study entry. * receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation prior to study entry. * use of investigational agents within 4 weeks prior to study enrollment. * current drug or alcohol use or dependence. * documented history of non-adherence to antiretroviral treatment regimen within 12 months prior to study entry.

Keywords: quadrivalent human papillomavirus vaccine (hpv) gardasil hiv infection evaluation of quadrivalent hpv vaccine in adolescents and young adults.
efficacy and safety of high-dose interferon alfa-2b (intron a®) for the adjuvant treatment of malignant melanoma (study p04083)

Conditions: Melanoma

Summary: the aim of this observational study is to document the efficacy and tolerability of high-dose interferon therapy in adult participants with malignant melanoma at high risk of relapse and to compare them with the survival times and relapse rates in previous studies (historical control).

observational study to evaluate the tolerability and efficacy (vs historical controls) of a high-dose therapy scheme with interferon-α-2b (introna®): adjuvant treatment with interferon-α-2 has been demonstrated in a number of studies to have an antiproliferative effect on malignant melanoma. in these cases a response rate of up to 20% could be achieved with a dose of 10 million iu or more 3x/week or daily. kirkwood et al. showed in a study carried out in ecog (the eastern cooperative oncology group, study no. 1684) that there was a clear and significant survival advantage versus the observation group with the following dose: 20 mio iu/m² interferon-α-2b (introna®) 5x/week iv over the course of one month followed by 11 months with 10 mio iu/m² 3x/week sc.

Eligibility criteria:
inclusion criteria: * male and female participants * age 18-70 years * malignant melanoma stage ii or iii (\>/= 1.5 mm tumor thickness, no distant metastases or malignant melanoma with lymph node metastases or lymph node metastases with unknown primary tumor * an excision border of at least 2 cm around the primary tumor * therapy must start within 12 weeks after surgery of the tumor/of the lymph node metastases * ecog status 0-1 (= karnofsky index \>/= 80) * laboratory parameters * hematocrit \>= 33% * leukocytes \>= 3000/μl * thrombocytes \>= 100000/μl * alanine aminotransferase(alt) \<= 2x normal values * bilirubin \<= 2x normal values exclusion criteria: * known allergy to one of the medications or any of its component parts * refusal on the part of participants capable of childbearing to use a reliable contraceptive * lactating mothers * presence of distant metastases * another primary tumor of different histological origin than corresponding to the indication (except when the relapse-free interval is \> 5 years, or the tumor is a cervical carcinoma in situ, a basal cell carcinoma or cutaneous squamous cell carcinoma) * participants on corticosteroid treatment or treatment with an immunomodulating substance * preexisting psychiatric illness, particularly serious depression * prior adjuvant radio-, chemo-, or immuno-therapy * treatment with an investigational drug within the prior 30 days * participant history that includes cardiac arrhythmia, cardiac insufficiency requiring treatment, or anthracycline administration * myocardial infarction within the prior year * an unstable medical condition (apart from the indication) that in the judgment of the investigating physician excludes the participants from the study * psoriasis (a relative exclusion criterion, since interferon can aggravate psoriasis; decision to be based on risk/benefit analysis)

Keywords: interferon-alpha
reliability and validity of the turkish version of the sensory eating problems scale

Conditions: Feeding and Eating Disorders

Summary: the aim of this study was to adapt to the sensory eating problems scale to turkish. within the scope of the study, firstly the turkish version of the scale will be developed and then its reliability and validity will be examined.

the etiology of childhood feeding problems is often complex and likely due to multiple factors, such as biological issues, oral motor deficits, and environmental contingencies. sensory processing, or the ability to receive, integrate, and process sensory input, such as visual, olfactory, or gustatory information, has also been speculated to influence eating. a growing literature has examined the association between sensory processing and eating behavior in several populations of children. while child feeding problems have been found to be associated with withsensory processing problems, clinicians could benefit from more specifics about the types of oral sensory problems most associated with feeding problems. for example, the oral sensory processing subscale of the sensory profile includes a collection of sensory problems associated with feeding difficulties such as gagging easily to food or utensils in the mouth, rejecting certain food tastes or smells, accepting limited food textures, biting the tongue or lips , but without documentation that identifies the separate dimensions of oral sensitivity problems relevant to children's feeding problems. further, along theoral sensory processing subscale of the sp, a particular oral sensory problems, such as sensitivity to texture, may be measured by only one or two items. sensory eating problems scale is a newly developed scale and can measure specific oral sensory problems in children. seps can also provide a more detailed assessment of sensory eating behavior than provided in previous studies by developing the sensory eating problems scale (seps) to identify specific dimensions of oral sensitivity children show during feeding. however; there is no short, easy to use and easy to understand sensory eating problems scale with the turkish version.

Eligibility criteria:
inclusion criteria: * the children had been referred to the clinics for eating problems that included failure to gain weight, dependence on tube feeding or oral supplements, difficulties with texture or learning to chew, limited diet variety, and mealtime behavior problems. exclusion criteria: -

Keywords: sensory feeding problems
amniotic fluid analysis

Conditions: Obstetric Labor Complications

Summary: this is a prospective study that will aid in ensuring the feasibility of timely and correct aspiration of amniotic fluid by study research team that include the clinical team taking care of the patient during her labor, timely transport and interpretation of specimens. it will also assist in providing information for the computation of necessary statistical measures (e.g. sample size, power analysis, etc.) for the study cohorts that lack the needed data in the medical literature.

can amniotic fluid be serially aspirated via an intrauterine pressure catheter (iupc) and successfully analyzed in labor? do abnormal amniotic fluid results collected serially predict which laboring patients will develop an intrapartum infection? can the results predict infection sooner than the current clinical diagnostic criteria as outlined by the 2015 nichd guidelines? how do the sensitivity, specificity, positive and negative predictive values compare to the 2015 nichd diagnostic criteria?

Eligibility criteria:
inclusion criteria: * singleton pregnancy * gestational age ≥ 37 weeks * age of participant ≥ 18 years old exclusion criteria: * multiple gestation * gestational age \< 37 weeks * intrauterine fetal demise * fetal anomalies * pre-gestational diabetics / gestational diabetics * chronic immune suppression with steroids (defined as \> 1 month of consistent steroid use) * oligohydramnios * women with documented non-obstetric infections within 2 weeks of admission; including use of any antibiotics within 2 weeks of admission for non-documented/suspected infections * repeat temperature not performed within 45 minutes of index fever (100.4 f) * index fever (100.4 f) is \> 1 hour after delivery * expectantly managed premature rupture of membranes
nab-paclitaxel in patients with er+/her2- recurrent metastatic breast cancer

Conditions: Breast Cancer

Summary: this study is a single-arm, open, multi-center clinical study of nab-paclitaxel as the therapy er+/her2- recurrent metastatic breast cancer。


Eligibility criteria:
inclusion criteria: 1. female, 18 to 70 years old; 2. histologically confirmed recurrent or metastatic breast cancer, er-positive (\> 10%), her-2 negative (definition: immunohistochemical \[ihc\] 0, 1+, or in situ hybridization \[ish\] negative it is defined as the ratio of her2 gene copy number to the number of cep17 signals is less than 2.0, or for single probe detection, the her2 gene copy number is less than 6); 3. after transfer, ≤2 lines and ≥1 line endocrine therapy, and progress; 4. at least one measurable lesion according to recist 1.1 ; 5. ecog score≤2; 6. expected survival≥3 months; 7. bone marrow function: white blood cells≥3×109/l, neutrophils≥1.5×109/l, platelets ≥100×109 / l, hemoglobin≥90g / l; 8. liver and kidney function: total bilirubin (tbil) ≤1.5 times the upper limit of normal value, alanine aminotransferase (alt), aspartate aminotransferase (ast) are ≤2.5 times the upper limit of normal value; if due to liver metastasis, the above indicators ≤5 times the upper limit of normal value; serum creatinine (cr) ≤1.5 times the upper limit of normal value; 9. taxane adjuvant chemotherapy for more than 1 year; 10. women of childbearing age have a negative pregnancy test and must agree to take effective contraceptive measures during the study and within 3 months after the last dose 11. sign written informed consent before the test. exclusion criteria: 1. received chemotherapy after transfer; 2. patients with congestive heart failure with a grade ii or above identified by the new york heart association (nyha) score; 3. uncontrolled brain metastases; 4. severe systemic infections; 5. peripheral neuropathy of degree ii or above within 4 weeks before enrollment, or patients known to be allergic or intolerant to this drug; 6. important organ diseases:liver and kidney dysfunction, history of myocardial infarction, unstable heart disease, chronic active hepatitis, etc .; 7. history of other malignant tumors within 5 years (except cured cervical cancer or skin basal cell carcinoma); 8. received other anti-tumor treatments or other experimental drugs within 1 month before starting treatment; 9. patients participating in other clinical trials at the same time; 10. any medical condition in which the investigator considers the patient unsuitable for study
schistosoma mansoni morbidity in children aged 1-5 years

Conditions: Intestinal Schistosomiasis

Summary: this study is about intestinal schistosomiasis, commonly known as bilharzia, in children aged 1-5 years along lake victoria shoreline.the children will be screened for s. mansoni and the effects of the disease will be assessed.children found positive with s. mansoni will be treated with praziquantel and followed up for a year.

the study has three phases: in the first phase (phase i) a baseline pretreatment schistosomiasis morbidity assessment of children aged 1-5 years will take place. the kato-katz technique will be used to detect and enumerate s. mansoni eggs in faecal samples from each participating child. communities with the highest s. mansoni prevalence and intensity will be chosen and included in the study. in the second phase (phase ii) the s. mansoni positive children will be divided randomly into two intervention groups, single and double dose praziquantel treatment arms. abdominal ultrasound will be combined with clinical examination to accurately identify hepatosplenomegaly. the sizes of both the liver and spleen will be examined. anthropometric measurements and hb for each child will also be recorded. in the last phase (phase iii), the effect of praziquantel on s. mansoni morbidity will be evaluated in all the treated children aged 1-5 years.

Eligibility criteria:
inclusion criteria: 1-5 years exclusion criteria: \ years

Keywords: schistosoma mansoni morbidity chemotherapy
sensory symptoms in tourette syndrome

Conditions: Tourette Syndrome

Summary: patients with tics will be asked to complete a series of validated questionnaires (in electronic and/or paper format) regarding symptoms and conditions often associated with tourette syndrome, including premonitory urges, sensory experiences, inattention, obsessive-compulsive tendencies, anxiety, and depression. participants will also be asked to complete a quality of life assessment. this series of questionnaires will be administered annually.

patients with tics will be recruited to participate in an observational study assessing extent and variation in non-motor features of tourette syndrome over time. each participant will complete a battery of validated questionnaires and scales online or in paper format (per patient preference), including the premonitory urge to tic scale (puts), the sensory gating inventory (sgi), the sensory perception quotient, the adhd self-report screening scale, and others. these questionnaires will be administered annually to patients. for the analysis, participants will be stratified by age into late adolescents (18-25 years old) and adults (older than 25 years) since adolescent development ends at approximately age 25.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * ability to provide informed consent and answer self-report questionnaires independently in english * diagnosis of tourette syndrome (ts), chronic motor tic disorder, or chronic vocal tic disorder exclusion criteria: * history of psychotic disorder * history of significant neurologic disorder (e.g., stroke) other than ts or another chronic tic disorder

Keywords: tourette syndrome premonitory urge sensory dysregulation hypersensitivity
robot-assisted intelligent rehabilitation treatment for methamphetamine use disorders.

Conditions: Amphetamine Addiction

Summary: the purpose of this research is to evaluate the efficacy and safety of robot-assisted rehabilitation intelligent system as a virtual stand-alone treatment, delivered with minimal clinical monitoring compared with treatment as usual in methamphetamine (ma) use disorders.

based on artificial intelligence technology, face recognition technology, virtual reality technology to develop an available robot-assisted rehabilitation intelligent system. then, using this intelligent system as a new way of psychotherapy to provide treatment for methamphetamine patients, and compare it with traditional treatment to verify the efficacy and safety of robot-assisted rehabilitation intelligent system in chinese methamphetamine patients.

Eligibility criteria:
inclusion criteria: * in accordance with the diagnostic and statistical manual of mental disorders-5 (dsm-5) for methamphetamine (ma) use disorders; * education level equal or more than 9 years; * have normal or corrected-to-normal vision; * have normal or corrected-to-normal hearing; * less than 3 months before last drug use; exclusion criteria: * current substance use (except nicotine or caffeine); * history of disease which influence cognition，such as seizure disorder、cerebrovascular disease、head injury or other severe medication conditions; * intelligence quotient less than 70.
risks of covid19 in the pregnant population

Conditions: COVID19

Summary: it is unclear how covid19 can be passed from mother to infant. the study investigators aim to collect maternal and neonatal samples from covid19-infected pregnant women and compare them to pregnant women who have clinical indications for covid 19 testing at the time of hospital admission but end up being covid19 negative. pregnant women who are either covid19 positive or covid19 negative with respiratory symptoms will be enrolled and followed during this study.

the objectives are to understand the prevalence of maternal fetal transmission, risk factors and outcomes of a covid19 positive pregnancy, and how the virus can be passed from mother to infant in the pregnant population at mayo clinic rochester mn. assessments will include the viral detection and viral load in maternal and fetal specimens collected from covid19 positive mother-baby dyads, presence of maternal and fetal inflammatory markers in blood and tissues, anti-covid igg and igm in maternal and neonatal blood, viral load and viral antigens in maternal and fetal specimens. placental gross and histopathologic changes in covid19 infected mothers, stratified by gestational age and disease severity, compared to control samples. .

Eligibility criteria:
inclusion criteria: * pregnant women ages 18 - 45 years of age and their newborn infants * willing and able to provide written informed consent * planning to deliver at mayo clinic in rochester, mn exclusion criteria: * positive for hiv, hbv, or tb * delivery does not occur at mayo clinic

Keywords: covid19 coronavirus pregnancy viral infection
trial of ped-1 in male patients with premature ejaculation

Conditions: Premature Ejaculation

Summary: the purpose of this study is to evaluate whether ped-1 is more effective than placebo in the treatment of premature ejaculation.

this study is to evaluate whether ped-1 is effective than placebo in the treatment of premature ejaculation. the patients will be randomized and allocated to two treatment groups into placebo, ped-1. the criteria for intravaginal ejaculation latency time(ielt) for enrollment will be \> or =2 min in the at least 75% of the sexual intercourse. to diagnosis premature ejaculation, the pedt(premature ejaculation diagnosis tool) will be used. the patients undergone drug free baseline period will take test drugs for 12 weeks.

Eligibility criteria:
inclusion criteria: * informed consent for subjects and partners * men 20-65 ages * stable monogamous relation at least for 6 mo * premature ejaculation diagnosis tool (pedt) more than 9 * at least 6 mo of premature ejaculation hx * ielt of =\ = 75% of evaluable events during 4 week screening period exclusion criteria: * history of medical or psychiatric illness * erectile dysfunction (\<21 international index of erectile function-erectile function (iief-ef) domain score) or other forms of sexual dysfunction * partner sexual dysfunction * known hypersensitivity to clomipramine and contraindications for clomipramine

Keywords: pe ielt dcit