Kornimate/medical-research-clean huggingface dataset:
a trial of thymalfasin in adult patients with hepatocellular carcinoma

Conditions: Carcinoma, Hepatocellular

Summary: the objective of this phase ii trial is to compare the efficacy and safety of 6 months of treatment with thymalfasin plus trans arterial chemoembolization (tace) with tace alone in adult patients with non-surgical hepatocellular carcinoma (hcc).


Eligibility criteria:
inclusion criteria: * signed written informed consent. * diagnosis of hcc by: 1. presence of hcc on biopsy (core biopsy), or, if biopsy is strongly contra-indicated due to safety or patient-related concerns, then the diagnosis of hcc can be determined by: 2. a new hepatic defect on imaging with an afp \> 1000 ng/ml, or 3. a new hepatic defect on ultrasound or ct with an afp \< 1000 ng/ml when one of the following is present: 1. at least two additional imaging techniques show signs characteristic of hcc, or 2. the new hepatic defect has doubled in diameter over time, or 3. the afp has progressively risen to \> 200 ng/ml and triples the mean baseline. * hcc must be unresectable and non-transplantable. * hematocrit \> 30%, platelet count \>= 50,000 per microliter, wbc \> 2.0 x 109/l, and polymorphonuclear white cell count \>= 1.0 x 109/l. * adequate renal function as demonstrated by serum creatinine level \< 1.5 mg/dl. * if the patient is a woman, she is using a definitive method of birth control in consultation with her physician, or is surgically sterile or post-menopausal. exclusion criteria: * concomitant chronic use of any drug known to be hepatotoxic, or of any immunosuppressive drug (use of oral contraceptives will not exclude an otherwise eligible patient). * presence of main portal vein thrombosis or hepatic artery malformation. * hcc amenable to treatment by surgical resection or hepatic transplantation. * hiv infection diagnosed by hiv seropositivity and confirmed by western blot. * concomitant or prior history of malignancy other than hcc within the last 10 years, except for curatively treated skin cancer or surgically cured in situ carcinoma of the cervix. * active infectious process that is not of a self-limiting nature. tb and aids are examples of infectious processes that are not of a self-limiting nature. * pregnancy as documented by a urine pregnancy test. women with reproductive potential must agree to practice an adequate method of birth control for the duration of the study. * alcohol or intravenous drug abuse within the previous 1 year. * previous treatment with thymalfasin. * patients with known hypersensitivity to iodine. * simultaneous participation in another investigational drug study, or participation in any clinical trial involving investigational drugs within 30 days of study entry.
effects of contact lens care regimens on the corneal epithelium

Conditions: Myopia

Summary: the purpose of this study is to compare the performance of two different contact lens care solutions, specifically their affects on the front surface of the eye.


Eligibility criteria:
inclusion criteria: 1. is at least 18 years old and has full legal capacity to volunteer. 2. has read, understood and signed an information consent letter. 3. is willing and able to follow instructions and maintain the appointment schedule. 4. is correctable to a visual acuity of 6/6 or better (each eye), with their habitual visual correction. 5. has normal binocular vision (no strabismus, no amblyopia, and anisometropia less than or equal to 1.00 d). 6. has clear corneas and no active ocular disease. 7. has had an ocular examination in the last 2 years. 8. has not worn contact lenses before, or has worn contact lenses only for a trial period, with no trials occurring within the last six months. an ineligible contact lens wearer is one who: 9. responds positively to points 1 to 7 above. 10. has a distance contact lens prescription between -0.50d and -9.00 d. 11. has astigmatism less than or equal to -1.00d cyl. 12. currently wears silicone hydrogel contact lenses successfully. 13. agrees to wear the study lenses on a daily wear basis without the use of ocular or lens lubricants. exclusion criteria: 1. has undergone corneal refractive surgery. 2. is aphakic. 3. has any active ocular disease. 4. has any systemic disease affecting ocular health. 5. is using any systemic or topical medications that may affect ocular health. 6. has known sensitivity to the diagnostic pharmaceuticals to be used in the study. 7. is pregnant or lactating. 8. is participating in any other type of clinical or research study. an ineligible contact lens wearer is one who: 9. responds positively to any of points 1 to 8 above for exclusion criteria. 10. has known sensitivity to the contact lens care solutions used in the study. 11. has ocular or systemic allergies that could adversely affect contact lens wear. 12. has any ocular pathology or severe insufficiency of lacrimal secretion (dry eyes) that would affect the wearing of contact lenses. 13. has pinguecula/pterygium that in the investigator's judgement makes contact lens wear inadvisable.
hetrombopag for the treatment of chemotherapy-induced thrombocytopenia in subjects with malignancy.

Conditions: Chemotherapy-Induced Thrombocytopenia

Summary: randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of hetrombopag in subjects with chemotherapy-induced thrombocytopenia receiving chemotherapy for the treatment of solid tumors.


Eligibility criteria:
inclusion criteria: 1. men and women, 18-75 years of age; 2. participant with a confirmed diagnosis of solid tumor receiving a chemotherapy regimen; 3. participant experienced thrombocytopenia and chemotherapy delay; 4. ecog performance status 0-1; exclusion criteria: 1. screening and baseline platelet count\< 30×109/l; 2. participant has experienced thrombocytopenia due to any etiology other than chemotherapy within 6 months of screening; 3. participant has any history of hematologic diseases other than chemotherapy-induced thrombocytopenia; 4. participant has serious bleeding symptoms; 5. participant has no hepatic metastases, alt/ast\>3uln, tbil\>3uln; with hepatic metastases, alt/ast≥5uln, tbil≥5uln; 6. blood cr≥1.5uln or egfr≤60 ml/min（cockcroft-gault）; 7. history of allergy to the study drug; 8. participant with hiv; 9. pregnant or lactating women; 10. other conditions that may affect participant's safety or trial evaluations per investigator's discretion
study of avutometinib (vs-6766) +defactinib with gemcitabine and nab-paclitaxel in patients with pancreatic cancer

Conditions: KRAS Activating Mutation; Metastatic Cancer; Pancreas Cancer; Neoplasms Pancreatic; Malignant Neoplasm of Pancreas

Summary: this study will assess the safety and efficacy of avutometinib (vs-6766) and defactinib in combination with gemcitabine and nab-paclitaxel in patients with pancreatic ductal adenocarcinoma (pdac) who have been previously untreated.

this is a multicenter, non-randomized, open-label phase 1/2 study designed to evaluate safety, tolerability and efficacy of avutometinib (vs-6766) and defactinib in combination with gemcitabine and nab-paclitaxel in patients previously untreated metastatic pancreatic ductal adenocarcinoma (pdac).

Eligibility criteria:
inclusion criteria: * male or female subjects ≥ 18 years of age * histologic or cytologic evidence of metastatic pancreatic ductal adenocarcinoma. * an eastern cooperative group (ecog) performance status ≤ 1 * measurable disease according to recist 1.1 * adequate organ function * adequate cardiac function * agreement to use highly effective method of contraceptive exclusion criteria: * patients with pancreatic neuroendocrine tumors * prior or concomitant treatment for metastatic pancreatic ductal adenocarcinoma * prior treatment with inhibitors of the ras /mapk pathway \[e.g. mek inhibitors\] or inhibitors of fak * history of prior malignancy, with the exception of curatively treated malignancies * major surgery within 4 weeks (excluding placement of vascular access) * concurrent heart disease or severe obstructive pulmonary disease * concurrent ocular disorders * active skin disorder that has required systemic therapy within the past 1 year * patients with interstitial lung disease or pulmonary fibrosis or severe lung disease, pulmonary edema, and adult respiratory distress syndrome * known sars-cov2 infection ≤28 days prior to first dose of study therapy

Keywords: avutometinib (vs-6766) metastatic cancer kras mutation pancreatic cancer
liver steatosis and stiffness in hiv

Conditions: HIV Infections; Fatty Liver; Liver Fibroses

Summary: background: with the advances in treatment and clinical care, individuals with human immunodeficiency virus (hiv) infection have experienced an increase in life expectancy. liver disease is common among hiv-infected patients due to the shared routes of transmission of hiv and viral hepatitis. nonalcoholic fatty liver disease (nafld) is the most common cause of elevated aminotransferases in hiv-monoinfected adults without hbv or hcv. vibration-controlled transient elastography (vcte) has been shown to have good sensitivity and specificity for assessment of liver fibrosis in hiv and viral hepatitis coinfected patients, as well as in hiv-negative nash population. controlled attenuation parameter (cap), a novel physical parameter developed using the postulate that fat affects ultrasound propagation, measures the ultrasound attenuation at the center frequency of the fibroscan®. study design: this is a prospective observational study. objective: the aim of this study is to evaluate the liver steatosis and fibrosis in hiv-infected patients by noninvasive methods of vcte and cap. methods: patient number: 200 inclusion criteria: 1. age: 20-65 years 2. males and females with hiv infection diagnosed by infection doctors 3. willing and able to comply with the study requirements 4. willing and able to provide written informed consent to participate in the study exclusion criteria: 1. pregnancy 2. unable to complete the noninvasive procedure of vcte and cap 3. unwilling to provide written informed consent to participate in the study


Eligibility criteria:
inclusion criteria: 1. age: 20-65 years 2. males and females with hiv infection diagnosed by infection doctors 3. willing and able to comply with the study requirements 4. willing and able to provide written informed consent to participate in the study exclusion criteria: 1. pregnancy 2. unable to complete the noninvasive procedure of vcte and cap 3. unwilling to provide written informed consent to participate in the study

Keywords: human immunodeficiency virus liver steatosis liver fibrosis controlled attenuation parameter transient elastography
randomized, controlled trial of kangaroo mother care in increasing the rate of weight gain among neonates

Conditions: Low Birth Weight Among Neonates

Summary: a randomized, controlled trial of kangaroo mother care (kmc) to determine the effectiveness in increasing the rate of weight gain among low birth weight neonates.

a randomized, controlled trial of kangaroo mother care (kmc) versus conventional care to determine the effectiveness of kmc in increasing the rate of weight gain among low birth weight neonates and if it will decrease sepsis rate and shorten hospital stay among the group.

Eligibility criteria:
inclusion criteria: * birth weight \<1500 grams and stable neonates (no dependency on oxygen and /or intravenous fluid, ability (at least partial) to feed) with stable vital signs for the past 24 hours (normal temperature (36.5-37.5 °c), * normal heart rate (120-160 bpm), normal blood pressure per age * no apnea * no intravenous lines or with well-secured peripheral line * no sepsis * no emerging signs of sepsis * on iv antibiotic therapy but clinically stable * can require photo therapy but with stable and not rising total serum bilirubin (tsb) level or tsb is not in high risk zone. exclusion criteria: * neonates with chromosomal and life threatening congenital anomalies, who were severally ill * whose mothers are critically ill and whose mothers were unable to comply with the follow up schedule.

Keywords: kangaroo mother care(kmc), low-birth weight, neonates
study of cetuximab in squamous cell carcinoma of the skin expressing egfr

Conditions: Skin Diseases; Carcinoma, Squamous Cell

Summary: the purpose of this study is to determine whether cetuximab is effective in the treatment of locally advanced or metastatic squamous cell carcinoma of the skin expressing egfr.

patients with locally advanced or metastatic squamous cell carcinoma (scc) of the skin are often bad responders to conventional chemotherapy included cisplatin. the investigation of the egfr expression may allow identifying new molecular targets for novel therapeutic strategies in patients with locally advanced or metastatic scc of the skin. several publications in the literature for primary lesions and one publication for metastatic lesions showed that egfr was expressed in 80-90% of scc of the skin. immunohistochemistry studies performed at the gustave roussy institute confirm these data: they found an over-expression of egfr in 90% of patients with metastatic disease. these results are in favor of the investigation of cetuximab in patients with locally advanced or metastatic scc of the skin expressing egfr. cetuximab is a monoclonal antibody targeted against egfr administered weekly by intravenous route; it may be prescribed as out hospital to patients with locally advanced or metastatic scc of the skin expressing egfr. due to the low occurrence of locally advanced or metastatic scc of the skin, a multicenter trial will be required.

Eligibility criteria:
inclusion criteria: * histological scc of the skin expressing (ihc) moderately or highly the egfr (++ and +++, on a semi-quantitative scale). * locally advanced or metastatic scc of the skin not suitable for local surgery with documented progression. * presence of at least one measurable target lesion by recist criteria. * at least one lesion accessible to biopsies. * ecog performance status \< 2. * life expectancy \> 3 months. * age \> 18 years. * normal hematological (neutrophils \> 1.5x109 cells/l, platelets \> 100x109 cells/l), hepatic (bilirubin \< 1.5 times the upper limit of the normal range (uln); alkaline phosphatase and transaminases \< 5 x unl in case of hepatic metastases or \< 2.5 x unl in absence of hepatic metastases) and renal (serum creatinine \< 150 micromol/l) functions. * written informed consent. * in case of second tumor,excepted carcinoma of the cervix and adequately treated basal or squamous cell skin carcinoma, the possibility for including a patient may be discussed with the principal investigator. exclusion criteria: * prior chemotherapy * prior radiotherapy \< 1 month. * prior therapy with agent targeting egfr * unstable systemic diseases or active uncontrolled infections. * patients (male and female) not using effective contraception if of reproductive potential. * females pregnant or lactating. women of child bearing potential must have a negative serum or urine pregnancy test prior to start each cycle of treatment.

Keywords: carcinoma, squamous cell skin cetuximab epidermal growth factor receptor
a study to determine the location of the blind spot and the macula-disc centre distance on a fundus photograph

Conditions: Generalized Visual Field Contraction or Constriction

Summary: the study is aimed to develop a new reaction-time based method for examining the visual field and to study the effect of refractive error on the magnification of a fundus photograph in order to evaluate the true size of a retinal feature.


Eligibility criteria:
inclusion criteria: * no disease that effect the fundus photograph or visual field exclusion criteria: * any disease that effects the fundus photograph or visual field

Keywords: keyword: blind spot
food-effect and metabolism study in healthy subjects

Conditions: Solid Tumor

Summary: this study evaluates the food-effect of one-dose fluzoparib in healthy subjects. the participants receive fluzoparib 120mg in fed state in period 1 followed by administration of fluzoparib 120mg in fasted state in period 2.


Eligibility criteria:
inclusion criteria: * able and willing to give written informed consent. * must be willing to comply with the requirements of the study. * willing to use a medically acceptable method (as defined by the investigator) of birth control in the 6 months. * male or female aged 18-50 years. * weight more than 45kg, bmi within 18 and 28 kg/m2. * no clinically significant abnormalities in physical examination and lab tests. exclusion criteria: * pregnant or breast-feeding women. * no history of alcohol or drug abuse within the past year. * participation in any clinical trial of an experimental drug or device in the previous 3 months. * any medical condition or clinical laboratory test which in the judgment of the investigator makes the subject unsuitable for the study.
effect of position on back pain and comfort after angiography

Conditions: Coronary Angiography

Summary: after coronary angiography, back pain and comfort levels were measured while the intervention group was positioned and the control group was not positioned

patients were assigned to the control and intervention groups by the minimization method. data were collected using the visual analog scale (vas) and a patient introduction form to assess the pain and comfort levels of the patients. prior to the starting the research, the necessary permissions were obtained from the institution where the study was conducted, from the patients and the ethics committee. in the analysis of data, frequency and percentage values, kolmogorov-smirnov test for the normal distribution of continuous variables, chi-square for comparisons of qualitative variables, two-way analysis of variance for comparison of repeated measurements of pain and comfort scores according to groups, and the relationship between two continuous variables were evaluated with the pearson correlation coefficient. p\<0.05 was considered statistically significant. ibm spss statistics 23 package program was used for the analysis of the date. the intervention group was hospitalized in supine position after coronary angiography. the first measurement was taken when the patient was placed in bed after the procedure, and the patient introduction form and vas for comfort and pain were applied (hour 0). following the withdrawal of the mattresses, the patient was given the semi-fowler position. vas was applied at the 2nd and 4th hours after the positioning. patients in the control group were placed to bed in the supine position in accordance with the routine practice of the clinic at the exit of coronary angiography and were allowed to stay in this position for six hours. when the patients were put to in bed, the patient introduction form, vas were applied for comfort and pain (0. hour). vas was applied at the 2nd and 4th hours following the removal of the mattresses. patients' back pain and comfort were evaluated, and the results were recorded on the relevant forms.

Eligibility criteria:
inclusion criteria: * coronary angiography for the first time in the coronary intensive care unit and cardiology clinic * volunteer to participate in the study * femoral angiography procedure performed * it created patients who had no obstacle to communication. exclusion criteria: * more than one coronary angiography procedure was performed * not volunteering to participate in the study * radial angiography procedure was performed * having a history of back surgery, existing hernia, or chronic waist or back pain
an extension study of enclomiphene citrate in the treatment of men with secondary hypogonadism

Conditions: Secondary Hypogonadism

Summary: to determine the safety profile of androxal in men with secondary hypogonadism.

this study is an open-label, multi-center phase 3 extension study to evaluate the safety on continued treatment with androxal in subjects who completed either za-301 or za-302. the study requires 6 study visits (1 for an eye exam) and is approximately 7 months in duration. subjects will be treated for 26 weeks, starting at a daily dose of 12.5 mg. at visit 2 (week 6) subjects who do not achieve morning t values ≥450 ng/dl will be up-titrated to 25 mg. safety will be assessed by physical and visual acuity exams, slit lamp and fundoscopy, refraction eye exams, clinical laboratory tests and adverse event reporting.

Eligibility criteria:
inclusion criteria: • successful completion of either za-301 or za-302 exclusion criteria: • any condition which, in the opinion of the investigator, would make the subject an unsuitable candidate for enrollment in the study
clinical outcome of pacemaker patients according to pacing modality and primary indications

Conditions: Bradyarrhythmia

Summary: the study objective is to collect mid-term clinical outcome in a group of patients implanted with permanent pacemaker (pm) according to real-life clinical practice in a multicenter and international environment.

the principal objective of the opti-mind study is to collect data on two-year all-cause mortality in a general population implanted with a pm according to current clinical practice. additionally, the study aims to stratify the outcome by both known patient-related risk factors and by physiologic pacing mode setting (a specifically defined pm programming). stratification will be done for pre-specified classes of patients on the basis of their primary rhythm disease.

Eligibility criteria:
inclusion criteria: * patients implanted with a current boston scientific pacemaker (all altrua models) or any future commercially available boston scientific pm families according to international and local guidelines for pacemaker implantation; * patients who are willing and capable of providing informed consent, participating in all testing associated with this clinical investigation at an approved clinical investigational centre; * patients whose age is 18 years or above, or of legal age to give informed consent specific to state and national law. exclusion criteria: * unable to be followed up by the participating centres for a period of two years; * current device implanted for more than 15 days; * women of childbearing potential who are, or plan to become, pregnant during the time of the study (method of assessment upon physician's discretion); * patients who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the patient is participating in a mandatory governmental registry or extensions/amendments of the current protocol. each instance should be brought to the attention of the sponsor to determine eligibility.

Keywords: cardiovascular pacemaker mortality physiologic pacing