Kornimate/medical-research-clean huggingface dataset:
cmv-specific t cell immunity test indicated prophylaxis of letermovir after all-hsct

Conditions: Hematologic Malignancy

Summary: to evaluate the efficacy of cmv-specific t cell immunity test in prolonged usage of letermovir for avoiding late-onset cscmvi after all-hsct.

reactivation of cytomegalovirus (cmv) leads to significant morbidity and mortality following allogeneic hematopoietic stem cell transplantation (allo-hsct). letermovir (ltv) has substantially reduced the risk of clinically significant cmv infection (cscmvi) in cmv seropositive recipients of allo-hsct. ltv discontinuation after day 100 (d100) has been reported to increase the risk of late-onset cscmvi, causing by impaired reconstitution of cmv-specific t immunity. the investigator sought to decrease the probability of cs-cmvi after letermovir withdrawal. restoration of cmv-specific t cells is imperative for effective control of cmv reactivation following allo-hsct. letermovir has been found impending recovery of cmv-specific t immunity. the investigators' retrospective study has proved that lower cmv-specific cd4+ t cells (\<2.01 cells/µl) at week 8 increased the risk of late-onset cmv reactivation (50.0%) compared to the higher ones (7.69%, p=0.04) in letermovir prophylaxis. thus, the guidance of cmv-specific cell immunity is recommended in letermovir prophylaxis. therefore, the investigator conduct a multicenter, randomized, controlled study based on retrospective research to further explore and validate the efficacy of cmv-specific t cell immunity test guiding the prolonged usage of letermovir.

Eligibility criteria:
inclusion criteria: * first allogeneic hematopoietic stem cell transplantation; * 18-70 years old; * use cytomegalovirus prophylaxis with letemovir after allo-hsct; * cmv ig g d+/r+; exclusion criteria: * allergy, known hypersensitivity to letermovir tablet or injection components; * cmv dnaemia within six months before transplantation or previous cmv disease; * presence of organ failure and inability to tolerate allogeneic hematopoietic stem cell transplantation; * second transplantation; * combination of immunodeficiency diseases; * those judged by the investigator to be unsuitable for participation in this trial.
real-world study on liver cancer risk in chronic hepatitis b patients with family history of liver cancer

Conditions: HBV; HCC

Summary: this study is a prospective, multicenter, real-world cohort study designed to compare the long-term outcomes of chronic hepatitis b patients with a family history of hbv-related hepatocellular carcinoma (hcc) who receive peg ifnα-2b combined with nucleos(t)ide analogues or nucleos(t)ide monotherapy. the primary endpoint is the incidence rate of hcc, and secondary endpoints include the rate of hbsag seroclearance, changes in liver fibrosis, and survival rates. the study will last for 5 years and enroll approximately 15,000 patients, aiming to provide evidence-based optimization for chb treatment regimens.


Eligibility criteria:
inclusion criteria: * (1) chronic hepatitis b (chb) patients with hbsag positivity for over 6 months; (2) family history of hbv-related hepatocellular carcinoma (hcc) (first- or second-degree relatives with hbv-related hcc); (3) age ≥ 30 years, regardless of gender; (4) based on real-world clinical practice, patients receiving nucleos(t)ide analogue (na) therapy, such as entecavir (etv), tenofovir disoproxil fumarate (tdf), tenofovir alafenamide fumarate (taf), or tenofovir amibufenamide (tmf), or those receiving combination therapy with nucleos(t)ide analogues and peg ifnα-2b; (5) negative pregnancy test within 24 hours before the first dose (for women of childbearing potential); (6) voluntary participation, with the ability to understand and sign the informed consent form. exclusion criteria: * (1) patients diagnosed with hepatocellular carcinoma (hcc) or malignancies in other organ systems prior to treatment; (2) patients with contraindications to peg ifn α-2b (refer to the guidelines for the prevention and treatment of chronic hepatitis b (2022 edition) for details); (3) patients in the immune-tolerant phase of hbv infection; (4) patients scheduled for or with a history of organ transplantation; (5) patients with hypersensitivity to interferon or any contraindication listed in the drug's prescribing information; (6) other conditions deemed unsuitable for enrollment by the investigator.
effect of oral isotretinoin on the level of serumykl40 in acne vulgaris patients

Conditions: Acne Vulgaris

Summary: the aim of the study is to evaluate the effect of oral isotretinoin on serumykl40 in acne vulgaris patients.

acne vulgaris is a common chronic inflammatory disease of the skin. it is found in about 80% of young adults and adolescents. it is a disease that affects the pilosebaceous units of the skin and may result in inflammatory or non-inflammatory lesions,oral isotretinoin (13-cis-retinoic acid) is the only drug that counteracts all the pathogenetic mechanisms that contribute to the development of acne .the standard dose of isotretinoin is 0.5 to 1 mg/kg per day for 4 months to a cumulative dose of 120-140 mg/kg is effective in the management of acne vulgaris the scope of our study is to detect serum ykl-40 level in acne patient before and after oral isotretinoin treatment

Eligibility criteria:
inclusion criteria: 1. healthy persons of both sexes with moderate and severe acne. 2. age above 14 years. exclusion criteria: 1. pregnant and lactating women, immunocompromised patients. 2. history of chronic liver disease, hyperlipidemia, non-inflammatory acne conditions, , history of neurologic disorders, history of neoplastic disorders, and history of cardiac disease. 3. history of systemic acne treatment for at least 4 weeks prior to inclusion and no topical treatments for at least 2 weeks. 4. cases with known hypersensitivity reaction to isotretinoin.
study of enzastaurin with 5-fluorouracil/leucovorin (5-fu/lv) plus bevacizumab as maintenance regimen following first line therapy for metastatic colon cancer

Conditions: Colorectal Cancer

Summary: this study will evaluate the addition of enzastaurin to 5-fu (5-fluorouracil)/lv (leucovorin) plus bevacizumab in the maintenance of best response obtained with 6 cycles of first-line therapy consisting of 5-fu/lv + oxaliplatin (folfox) or 5-fu/lv + irinotecan (folfiri), plus bevacizumab in patients with metastatic colorectal cancer.


Eligibility criteria:
inclusion criteria: * histologic diagnosis of locally advanced or metastatic colorectal cancer (crc) that is not curable. the histology types to be included are adenocarcinoma, mucinous adenocarcinoma, signet ring, and undifferentiated. patients with neuroendocrine carcinomas will be excluded. * received 6 cycles (3 months \[12 weeks\]) of first-line therapy with folfox or folfiri, plus bevacizumab for metastatic crc. patients have received at least 5 cycles with bevacizumab. patients who received 6 cycles of first-line therapy with folfox or folfiri, plus bevacizumab for recurrent crc that has relapsed at least 12 months after completion of adjuvant therapy will also be included. all standard folfox (folfiri) regimens given on a biweekly schedule will be permitted; however, 21-day regimens will not be allowed. * no more than 4 weeks may pass between the end of first-line therapy (that is, day 14 of cycle 6) and randomization. * documented evidence of tumor response of complete response (cr), partial response (pr), or stable disease (sd) by computed tomography (ct) scan or magnetic resonance imaging (mri). confirmation of response is not required. exclusion criteria: * are unable to swallow tablets. * have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry. * have known central nervous system metastases. * are receiving concurrent administration of any other antitumor therapy. * patients who have significant heart, liver, kidney, or psychiatric disease or have an active infection
endostar combination with chemotherapy for the metastatic nasopharyngeal carcinoma

Conditions: Nasopharyngeal Carcinoma

Summary: the investigators designed this study to evaluate the efficiency and the acute toxicities of recombinant human endostatin (endostar) combined with chemotherapy in the metastatic nasopharyngeal carcinoma (npc).

to evaluate the progression free survival (pfs), overall survival (os), acute adverse reaction of recombinant human endostatin (endostar) combined with chemotherapy to the metastatic nasopharyngeal carcinoma (npc).

Eligibility criteria:
inclusion criteria: * diagnosed metastatic npc patient who have received radiotherapy or chemoradiotherapy with an at least 6 months interval * have measurable lesions * no dysfunction of the major organs * can understand this study and give a signed informed consent certificates * without a history of allergic reaction to the biological agents exclusion criteria: * pregnant or lactating women; women of child-bearing age without contraception * with a serious infection or dysfunction of the major organs * have taken other antitumor drugs during the period of 30 days ahead of this clinical trial * allergic to the escherichia coli preparations * cann't understand this study and give a signed informed consent certificates

Keywords: recombinant human endostatin nasopharyngeal carcinoma chemotherapy
self-management telehealth program for scleroderma

Conditions: Scleroderma

Summary: scleroderma causes the skin on the hands to harden, causing the hands to contract, and the fingers to bend abnormally, which affect the patient's work and quality of life. this project aims to test the effect of a self-management telehealth program. the goal of this clinical trial is to improving hand strength and function in ssc patients. participants will: randomly into 3 groups; a) usual education, b) watching 3.27-minute video guide as needed adding on usual education, c) watching video guide and weekly telephone notifications adding to usual education. a physical therapist coached home program for self-hand and joint exercise, a nursing coach home routine hand care. visit the clinic with a diary at 6 weeks after program for checkups and tests researchers will compare hand strength and function, self-management behavior, hamis scores, hand grip strength (hgs), and quality of life (qol) between groups, as well as the changes in these parameters at week 6 compared to baseline.


Eligibility criteria:
inclusion criteria: adult ssc patients who met the 2013 classification criteria of the american college of rheumatology/european alliance of associations for rheumatology and fulfilled all of the following criteria were included: * ability to communicate in the thai language * stable disease * hand involvement defined as a hand mobility in scleroderma score ≥1 or a limited range of motion in at least one hand joint * ownership of a smartphone capable of recording video clips * ability to access videos on their smartphone independently exclusion criteria: * severe contracture deformity of the hands (defined as a hand mobility in scleroderma score of 27) * impaired hand sensation; cognitive, hearing, or visual impairment; or physical limitations (e.g., paralysis, muscle weakness) * scheduled surgery involving the hand, eyes, or ears; or required hospitalization within the past 6 weeks * presence of infected wounds or active inflammation on the hand, wrist, or fingers that prevents performance of hand exercises

Keywords: systemic sclerosis scleroderma and related disorders exercise hand function hand deformity disability clinical trials
phase i/ii, open-label trial of three monoclonal antibodies

Conditions: HIV Infections

Summary: monoclonal antibody infusions will prevent rebound of viremia in well-suppressed haart-treated individuals who began therapy during acute and early hiv-1 infection.


Eligibility criteria:
inclusion criteria: hiv-1 infection, as documented by any licensed elisa test kit and confirmed by western blot at any time prior to study entry. acute or early hiv-1 infection at the time of haart initiation defined by hiv-1 rna detectable with a negative serology or a negative detuned elisa. haart for at least 15 months and no more than 1 detectable hiv-1 rna value (above the 50 copy/ml) for at least 6 months prior to screening. laboratory values * absolute neutrophil count (anc) equal to or greter than 750/mm3. * hemoglobin equal to or greater than 9.5 g/dl. * platelet count equal to or greater than 50,000/mm3. * calculated creatinine clearance (crcl) equal to or greater than 80 ml/min according to the cockcroft-gault formula: men: (140-age in years) x (wt in kg) = crcl (ml/min) 72 x (serum creatinine in mg/dl) female: (140-age in years) x (wt in kg) x 0.85 = crcl (ml/min) 72 x (serum creatinine in mg/dl) * ast (sgot), alt (sgpt), and alkaline phosphatase equal to or less than 5 x uln. * total bilirubin equal to or less than 2.5 x uln. * serum lipase equal to or less than 1.5 x uln negative serum pregnancy test within 14 days. all females of childbearing potential must agree to practice active birth control measures (barrier methods such as condoms, diaphragms, cervical cap, etc. or an intrauterine device such as a coil) to avoid pregnancy while receiving the study drugs and for 30 days after the last dose of the study drugs. additionally, men enrolled in the study should practice active birth control for the same period of time with their female partners of childbearing potential. men and women age \>18 years. ability and willingness of subject to give written informed consent - exclusion criteria: more than 1 detectable hiv-1 rna value (\>50 copies/ml) within 6 months of screening visit pregnancy and breast-feeding. active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements. serious illness (requiring systemic treatment and/or hospitalization) until subject either completes therapy or is clinically stable on therapy, in the opinion of the investigator, for at least 30 days prior to study entry. -

Keywords: treatment experienced hiv
use of color doppler in routine examination of fetal heart in second trimester

Conditions: Congenital Heart Defects

Summary: to evaluate the percentage of severe heart defect diagnosed with the use of color doppler at a routine fetal scan in the second trimester of pregnancy

almost all women in norway have a routine ultrasound examination in the second trimester, however, the detection rate of heart defect are only around 50%. in this study we use color doppler at three different levels in the fetal heart; the four chamber view, the outlet of the aorta on on the level of the great arteries. all heart defects at delivery are recorded and compared with the ultrasound findings.

Eligibility criteria:
inclusion criteria: * pregnant * 2nd trimester exclusion criteria: * unwilling

Keywords: ultrasound pregnancy fetal heart defects color doppler
effect on post-operative pain of tranexamic acid injection during shoulder surgery

Conditions: Shoulder Disease

Summary: arthroscopic shoulder surgery is a commonly performed minimally invasive surgery in which a camera (an arthroscope) is inserted inside the shoulder joint. this surgery is responsible for moderate to severe pain. it may require the use of opioid analgesics in the acute phase. one of the components of this pain may be the postoperative hematoma. pain is one of the main causes of patient satisfaction failure after shoulder surgery. finding ways to reduce this pain is a primary principle in the management of this surgery. until now, this management requires the frequent use of morphine. however, this use of morphine may conduct to adverse effects (nausea/vomiting, constipation, malaise, sweating), and even public health problems such as addiction. it is therefore interesting to look for ways to increase the patient's analgesia by other means, which will thus increase patient satisfaction and make his management more fluid. the effect on pain of hematoma reduction is rarely described in the scientific literature. the hypothesis of this study is that the intraoperative administration of intravenous (iv) tranexamic acid can reduce the hematoma and thus decrease postoperative pain.the aim of this study is to demonstrate that the use of iv tranexamic acid intraoperatively, compared to a placebo (sodium chloride 0.9%), reduces postoperative pain after arthroscopic shoulder surgery.


Eligibility criteria:
inclusion criteria: 1 - male or female aged 18 years old or more; 2- patient requiring shoulder arthroscopy; 3 - patient affiliated to a social security scheme; 4 - patient informed on the study and who has signed the informed consent form. exclusion criteria: 1. - tranexamic acid contraindications (hypersensitivity to the active substance or to any of the excipients, acute venous or arterial thrombosis, severe renal impairment, history of convulsions); 2. - pregnant or breastfeeding patient; 3. - patient under legal protection; 4. - patient taking part simultaneously to another clinical trial.

Keywords: shoulder pain arthroscopic shoulder surgery
asia pdl1 study among nsclc patients

Conditions: Locally Advanced or Metastatic NSCLC

Summary: medi-apex is a non-interventional, retrospective, cohort study to characterize pd-l1 expression and to assess the clinical characteristics and outcomes among nsclc patients

medi-apex is a non-interventional, retrospective, cohort study to characterize pd-l1 expression among nsclc patients and to assess the clinical characteristics and outcomes of these patients with specific attention to egfr, alk, and kras mutations. the study will determine whether pd-l1 is a prognostic factor in the asia-pacific patient population; the study will enrol nsclc patients with disease diagnosis between january 2010 and december 2014; the patients will be recruited from asia-pacific, potentially china, japan, and south korea. a total of approximately 750 patients will be enrolled in the study; around 250 nsclc patients will be enrolled per country.

Eligibility criteria:
inclusion criteria: 1. adult male or female (according to age of majority as defined in local regulations). 2. nsclc diagnosis between 01 january 2010 and 31 december 2014. 3. ffpet collected via core needle biopsy or resection and available in sufficient amount to complete pd-l1 testing. 4. ffpet tissue samples collected for nsclc original diagnosis determination or for further analysis (e.g. research or treatment purposes) until the index date. 5. patients with locally advanced or metastatic nsclc who have initiated 1st line palliative chemotherapy by 31 december 2014. exclusion criteria: 1. patients with locally advanced nsclc with resectable disease and treated with curative intent.

Keywords: nsclc
treatment of patients with covid-19 with convalescent plasma

Conditions: COVID-19

Summary: the covid-19 pandemic has been spreading continuously, and in brazil, until may 31, 2020, there have been more than 450.000 cases with more than 28.000 deaths, with daily increases. the present study proposes to evaluate the efficacy and safety of convalescent plasma in treatment of severe cases of covid-19 in a multicenter, randomized, open-label and controlled study

eligible patients will be randomized 1:1:1 into 3 treatment groups: a- standard (control); b- standard and convalescent plasma in a volume of 200ml (150-300ml); c- standard and convalescent plasma in a volume of 400ml (300-600ml). the bayesian multi-arm and multi-stage model will be used, which will allow an interim analysis after the inclusion of 30 patients, with repeated interim analyses for every 30 additional patients. with this, we expect to define not only the efficacy of convalescent plasma, but also the volume of plasma needed if efficacy is proven. the study will be interrupted if the efficacy of the convalescent plasma group is proven, so that all severely ill patients as defined in the study can receive the convalescent plasma treatment. the same will occur if there is no difference in primary outcome with the use of convalescent plasma or serious adverse effects.

Eligibility criteria:
inclusion criteria: * age = or \> than 18 years; . * laboratory-proven covid-19 infection by rt-pcr in any clinical sample . time since symptom onset less than 10 days at the time of screening; - . presence of covid-19 pneumonia, with a typical, indeterminate or atypical compatible image in a chest tomography exam (see definition below) - * presence of one of the following criteria: * need for\> 3l of o2 in the catheter / mask or\> 25% in the venturi mask to maintain o2 saturation\> 92% b presence of respiratory distress syndrome with pao2 / fio2 \<300mmhg if intubated, within 48 hours of orotracheal intubation * absence of a history of serious adverse reactions to transfusion, for example, anaphylaxis; - .participation approval by the research clinician exclusion criteria: * already enrolled in another clinical trial evaluating antiviral or immunobiological therapy for the treatment of covid-19. * iga deficiency * presence of a clinical condition that does not allow infusion of 400 ml of volume at clinical discretion * pregnancy or breastfeeding * receipt of immunoglobulin in the last 30 days * presence of significant risk of death within the next 48 hours at clinical discretion.

Keywords: covid-19 convalescent plasma efficacy safety
crustal study in china

Conditions: Coronary Artery Disease; Calcification

Summary: this is a prospective, multicenter, single-arm registry study, aimed to evaluate the clinical outcomes of using shockwave ivl catheter in the treatment of coronary artery calcification in real-world clinical practice.


Eligibility criteria:
inclusion criteria: * age ≥18 years. * patients with coronary artery calcification who are planned to undergo pci and are deemed in need of shockwave ivl catheter treatment by their physicians. * the subject or their legal representative agrees to sign the informed consent form. exclusion criteria: * the physician evaluates that the subject's expected lifespan is \<1 year. * the subject did not receive ivl treatment in the index procedure. * the subject is pregnant or lactating. * the subject is currently participating in another clinical study.
supporting parents of young children with type 1 diabetes in closed-loop system

Conditions: Type 1 Diabetes Mellitus

Summary: this study will examine the impact of a closed-loop insulin delivery system intervention on health and psychological outcomes in families with young children with type 1 diabetes (t1d).


Eligibility criteria:
to be eligible for the study, a child must meet the following criteria since enrollment in the cep 302 trial: 1. diagnosis of type 1 diabetes according to ada diagnostic criteria 2. time since diagnosis of at least six months 3. age between 2.00 and 6.99 years at enrollment 4. parental consent to participate in the study 5. completion of the cep 302 trial and in the continuation phase of the medtronic cep 302 trial using the medtronic minimed 670g pump with enlite3 sensor. to be eligible for the study, a parent must meet the following criteria: 1. parent or legal guardian of a child with type 1 diabetes meeting the "child" criteria outlined above. 2. age of 18.0 years or older. 3. parent comprehends written english. 4. parent understands the study protocol and signs the informed consent document. the presence of any of the following is an exclusion for the study (since enrollment in the cep 302 trial): 1. child has a medical disorder that in the judgment of the investigator will interfere with completion of any aspect of the protocol (e.g., pregnancy, kidney disease, adrenal insufficiency, skin condition that may hinder sensor application). 2. child has a neurologic disorder that in the judgment of the investigator will affect completion of the protocol 3. current use of oral glucocorticoids or other medications, which in the judgment of the investigator would be a contraindication to participation in the study 4. child is unable to completely avoid acetaminophen for duration of study

Keywords: 670g hybrid closed-loop system pediatric