Kornimate/medical-research-clean huggingface dataset:
assessing the prognosis of tace in combination with pd-1/pd-l1 inhibitors and molecular target therapies for hcc by using clinical and imaging biomarkers

Conditions: Hepatocellular Carcinoma

Summary: the purpose of this study is to id transarterial chemoembolization (tace) in combination with immune checkpoint inhibitors (icis) and molecular targeted therapies in patients with hepatocellular carcinoma (hcc) .


Eligibility criteria:
inclusion criteria: 1. has a diagnosis of hcc confirmed by radiology, histology, or cytology; 2. has not received any previous systemic therapy for hcc (including chemotherapy, molecularly targeted therapy, immunotherapy); 3. both pd-1/pd-l1 inhibitors and anti-angiogenesis drugs patients received only include marketed drugs but are not limited to hcc approval; 4. tace was performed up to 3 months after the first pd-1/pd-l1 inhibitor/anti-angiogenic drug treatment or within 1 month before treatment; 5. received at least 1 cycle of pd-1/pd-l1 inhibitor/anti-angiogenic drug combination therapy after tace treatment； 7. has repeated measurable intrahepatic lesions according to recist v1.1; exclusion criteria: 1. cholangiocarcinoma, fibrolamellar, sarcomatoid hepatocellular carcinoma, and mixed hepatocellular/cholangiocarcinoma subtypes(confirmed by histology, or pathology) are not eligible; 2. unable to meet criteria of combination timeframe described above; 3. missing follow-up data;

Keywords: hepatocellular carcinoma immune checkpoint iinhibitors transarterial chemoembolization real-world study
pp100-01 (calmangafodipir) for overdose of paracetamol

Conditions: Paracetamol Overdose

Summary: investigate the safety and tolerability of pp100-01 add-on treatment to the 12hr nac treatment regime in patients treated for paracetamol/acetaminophen overdose (pod) when nac treatment is initiated before 24hours post pod.

the study will be an open label, randomised, exploratory, rising dose design, nac controlled, phase 1 safety and tolerability study in patients treated with nac for paracetamol/acetaminophen overdose. entry into the study will depend on the patient's blood results confirming the need for nac. a total of 24 patients will be assigned into one of 3 dosing cohorts of 8 patients (n=6 for pp100-01 and nac; n=2 for nac alone). the study will primarily evaluate safety and tolerability for treatment with pp100-01 in combination with nac as compared to nac alone.

Eligibility criteria:
inclusion criteria: 1. any patient with capacity admitted to hospital within 24 hrs either a single acute pod or more than one dose of paracetamol (staggered) and deemed to require treatment with nac. 2. provision of written informed consent 3. males and females of at least 16 years of age exclusion criteria: 1. patients that do not have the capacity to consent to participate in the study 2. patients detained under the mental health act or deemed unfit by the investigator to participate due to mental health. 3. patients with known permanent cognitive impairment 4. patients who are pregnant or nursing 5. patients who have previously participated in the study 6. unreliable history of pod 7. patients presenting after 24hrs of pod 8. patients who take anticoagulants (e.g. warfarin) therapeutically or have taken an overdose of anticoagulants 9. patients who, in the opinion of the responsible clinician/nurse, are unlikely to complete the full course of nac e.g. expressing wish to self-discharge 10. prisoners 11. non-english speaking patients. (study information material will only be produced in english in view of the known and stable demographic of the edinburgh self-harm population).
progesterone treatment in female smokers - 12

Conditions: Tobacco Use Disorder

Summary: the purpose of this study is to investigate progesterone effects in female smokers

limited research has been done on the effects of gender and menstrual cycle in response to drugs of abuse in humans. the main goal of this pilot study is to investigate the safety and tolerability of progesterone treatment in female nicotine users. in addition, plasma progesterone levels reached with a single 200 mg dose of progesterone treatment will be measured. the study will be a double-blind placebo controlled, crossover trial in which 12 female smokers who are in the early follicular phase of their menstrual cycle will be enrolled. druing the experimental sessions, subjects will be given a single 200 mg dose of micronized progesterone or placebo and multiple blood samples will be obtained to measure the plasma levels of progesterone. starting 2 hours after progesterone or placebo treatment, subjects will have a self-administration period that will last around 2.5 hours. we hypothesize that administration of 200 mg of progesterone will achieve plasma progesterone concentrations similar to those found in the luteal phase of the menstrual cycle, 3-30 ng/ml.

Eligibility criteria:
inclusion criteria: female subjects aged 21-45 years with a smoking history of at least 20 cigarettes daily for at least 1 year. in good health as verified by medical history, screening examination, and screening laboratory tests. not pregnant as determined by pregnancy screening nor breast feeding, and using acceptable birth control methods other than hormonal contraceptives. exclusion criteria: history of heart disease, peripheral vascular disease, copd, liver diseases, abnormal vaginal bleeding, suspected or known breast malignancy, or any other medical condition which physician investigator deems inappropriate for subject participation. use of regular psychotropic medication (antidepressants, antipsychotics, or anxiolytics) and recent psychiatric history. amenorrhea. current use of oral or other types of hormonal contraceptives. abuse of alcohol or any other recreational or prescription drug. regular use of any other tobacco products, including smokeless tobacco and nicotine products. known allergy to progesterone or peanuts.
success rate, continence, and quality of life with a bioprosthetic plug for treating complex anal fistula

Conditions: Complex Anal Fistula

Summary: anal abscess-fistula disease is of common occurrence and has a significant impact on the quality of life of affected individuals. the course of abscess-fistula disease as well as its treatment modalities may affect anal continence. the present cohort study investigates the results of anal fistula plug surgery. in particular, this study focus on the impact of anal fistula plug surgery on fistula healing, quality of life, and anal continence. fifty patients will be included and followed up at 6 weeks and 6 months after surgery in the clinic of participating surgeons.

anal abscess-fistula disease is of common occurrence and has a significant impact on the quality of life of affected individuals. the clinical course of abscess-fistula disease as well as its treatment modalities may affect anal continence. anal fistula plug surgery is an health canada and fda approved surgical treatment that has demonstrated promising results in terms of fistula healing and minimal patients' burden. the present cohort study prospectively investigates the results of anal fistula plug surgery performed in teaching hospitals affiliated to the university of toronto. in particular, this study focus on the impact of anal fistula plug surgery on health-related quality of life, and its 2 major determinants anal continence and fistula healing. fifty patients will be included and followed up at 6 weeks and 6 months after surgery in the clinic of participating surgeons. quality of life and anal continence will be measured with the validated short form-36 health survey (sf-36 v2) and fecal incontinence score index (fisi) questionnaires, respectively. it is expected that the present study will provide objective information on the results and generalizability of anal fistula surgery, as well as on its impact on health-related quality of life and anal continence.

Eligibility criteria:
inclusion criteria: complex anal fistula as defined by * high transsphincteric fistula * extrasphincteric fistula * suprasphincteric fistula * recurrent fistula * multiple fistula openings, including horseshoe fistula * imperfect continence- jeopardized anal continence (anterior transsphincteric fistula, prior anal surgery) exclusion criteria: * uncomplicated fistula curable by simple fistulotomy * history of inflammatory bowel disease * chronic immunosuppressive treatment (ie, systemic steroids for \>3 days) * clinical heart failure as defined by a ccs angina severity class ≥ iii * untreated cancer or cancer diagnosed/treated (all modalities) within 6 months * estimated life expectancy inferior to 6 months * incompetent subject * pregnancy

Keywords: anal fistula anal continence health-related quality of life
predictive multimodal signatures associated with response to treatment and prognosis of patients with stage iv non-small cell lung cancer

Conditions: Non-small Cell Lung Cancer Metastatic

Summary: predicting response to therapy and disease progression in stage iv nsclc patients treated with pembrolizumab monotherapy, chemotherapy-pembrolizumab combination therapy or chemotherapy alone in the first-line setting.


Eligibility criteria:
inclusion criteria: * adult ≥18 years old * patient diagnosed with stage iv nsclc (de novo or earlier stage progression to stage iv) * absence of oncogene activating mutations eligible patients to targeted therapy (egfr, alk) * cohort a: received first line treatment with pembrolizumab monotherapy * cohort b: received first line treatment with chemotherapy and pembrolizumab combination therapy * cohort c: received first line treatment with chemotherapy doublet exclusion criteria: * prior anti-cancer therapy for actual stage iv nsclc * critical data missing (e.g., pd-l1 status, baseline millimetric imaging, first evaluation millimetric imaging) * patients participating in other clinical trials that modify the standard of care

Keywords: nsclc immunotherapy chemotherapy predictive models radiomics multimodal genomics machine learning
evaluating the safety and pharmacokinetics of abt-414 for subjects with glioblastoma multiforme

Conditions: Glioblastoma Multiforme

Summary: this study is evaluating the safety and pharmacokinetics of abt-414 in subjects with glioblastoma multiforme.


Eligibility criteria:
inclusion criteria: 1. glioblastoma multiforme (gbm) 2. 70 or above on karnofsky performance status 3. adequate bone marrow function 4. recurrent gbm per rano criteria 5. subjects must have confirmed egfr amplification by central lab exclusion criteria: 1. for subjects with recurrent gbm in arm b, subject has received prior treatment with bevacizumab, nitrosourea, or has secondary gbm 2. for subjects with recurrent gbm in arm c, subject has received prior treatment with bevacizumab, or has secondary gbm 3. allergies to temozolomide, dacarbazine, igg containing agents 4. anti-cancer treatment 28 days prior to study day 1, except in arm b expanded cohort temozolomide therapy is allowed 5. subjects that have had more than one disease recurrence

Keywords: gbm
head-to-head comparison of [18f]f-psma-n5 with [18f]f-psma-1007 pet/ct in pca diagnosis, recurrence, and metastasis

Conditions: Prostate Cancer; PET/CT

Summary: to prospectively evaluate the radiodrug biodistribution of a novel pet imaging agent \[18f\]f-psma-n5 in different organs of prostate cancer patients and its diagnostic efficacy in the diagnosis, recurrence and metastasis of prostate cancer, and to compare with \[18f\]f-psma-1007.

\[18f\]f-psma-n5 pet/ct was used for initial assessment of prostate cancer or detection of recurrence. the maximum standardized uptake value (suvmax) was used to evaluate tumor uptake. the sensitivity, specificity, the number and accuracy of lesions identified and the distribution of lesions in each organ were calculated and compared with those of \[18f\]f-psma-1007 pet/ct.

Eligibility criteria:
inclusion criteria: * aged from 18 to 90 years old; * complete mri images and clinical data (such as psa level, gleason grade, etc.); * prostate cancer detected by psa or imaging examination, or clinically suspected recurrence after standardized treatment; * simultaneous \[18f\]f-psma-n5 and \[18f\]f-psma-1007 examinations within two weeks; * willing to undergo surgery or needle biopsy for pathological examination after examination, or confirmed as prostate cancer by histopathology before or after treatment; * sign informed consent. exclusion criteria: * patients who cannot cooperate with the examination; * concurrent malignant tumors; * previous alcohol allergy; * patients with liver and kidney dysfunction; * other circumstances deemed by the investigator to be inappropriate for trial participation.
a cohort study of hyperthermia and imiquimod for the treatment of flat warts

Conditions: Human Papilloma Virus

Summary: flat warts are a superficial viral skin disease, extremely common in childhood.treatment of warts is often difficult and involves different destructive procedures.although several pharmacological and physical topical treatments are available (keratolytic agents, electrosurgery, cryotherapy, carbon dioxide laser), results are often unsatisfactory in terms of efficacy (frequent recurrence) and cosmetic outcome (scars, inflammatory reactions, transient or permanent hyper- or hypopigmentation). mild local hyperthermia with a certain temperature range has been successfully used in the treatment of some diseases. it has been utilised in the treatment of some neoplasm, fungal and hpv infections. investigators' study found that local hyperthermia at 44°c could cleared hpv in more than half of the patients with plantar warts. investigators also note the fact that in patients with multiple lesions, the clearance of the target lesion is commonly followed by clearance of other distant lesions, a phenomenon suggesting that local hyperthermia could aid in establishing a specific immune response to eliminate hpv.so the purpose of the study is to evaluation local hyperthermia in the treatment of flat warts appropriate control arms were designed for different conditions.


Eligibility criteria:
inclusion criteria: * 12-65 years old; * diagnosis confirmed; * signed informed consent exclusion criteria: * pregnant woman; * local or systematic treatment within 3 months; * comorbidity of other severe gynecological inflammation, * infection, or tumor; * comorbidity of other serious illnesses; * no guarantee of timely treatment and follow-up

Keywords: hyperthermia human papillomavirus virus flat warts
efficacy and safety of ttm in adults with ecpr.

Conditions: Cardiac Arrest

Summary: investigators hypothesize that there is a difference in the 30-day survival rate and good neurological outcome rate between two groups of cardiac arrest patients undergoing ecpr, one group receiving hypothermia and the other group receiving normothermia. among the patients undergoing extracorporeal cardiopulmonary resuscitation, after screening with inclusion criteria as well as exclusion criteria, informed consent for the experiment was signed and randomly assigned into 2 groups. one group underwent extracorporeal cardiopulmonary resuscitation combined with hypothermia (34°c) and the other group underwent extracorporeal cardiopulmonary resuscitation combined with normothermia (36.5-37.5℃). information related to the prognosis of the participants in both groups was obtained, evaluated statistically, and final conclusions were drawn.


Eligibility criteria:
inclusion criteria: 1. patients aged ≥18 and ≤60 years; 2. patients with in-hospital and out-of-hospital cardiac arrest of any initial rhythm; 3. patients who have received cardiopulmonary resuscitation for \>10 minutes without achieving return of spontaneous circulation; 4. patients with a reversible cause of cardiac arrest (acute myocardial infarction, pulmonary embolism, all initial defibrillatable rhythm, cardiomyopathy); exclusion criteria: 1. cardiac arrest due to trauma; 2. pregnant and lactating women; 3. unwitnessed cardiac arrest; 4. out-of-hospital cardiac arrest not receiving cpr within 5 minutes; 5. \> 60 minutes from the onset of cardiac arrest to the initiation of extracorporeal cardiopulmonary resuscitation; 6. achievement of return of spontaneous circulation before the start of external cardiopulmonary resuscitation; 7. intracranial hemorrhage or suspected intracranial hemorrhage; 8. pre-existing neurologic impairment (cpc ≥ 3) prior to the onset of cardiac arrest; 9. those with end-stage heart failure; 10. those with new-onset cerebral hemorrhage or cerebral infarction; 11. other vascular conditions such as severe plaque in bilateral femoral arteries that cause difficulty in tube placement; 12. patients with combined malignant tumors; 13. other serious diseases with a life expectancy of \<1 year; 14. refusal to perform extracorporeal cardiopulmonary resuscitation and/or target temperature administrators. 15. temperature \<30°c.

Keywords: cardiac arrest extracorporeal cardiopulmonary resuscitation hypothermia normothermia clinical outcome randomized controlled trial
subjective and objective outcome of ess in crswnp

Conditions: CRS

Summary: (a): beidseitige fronto-spheno-ethmoidektomie mit erweiterung des natürlichen zuganges zur stirnhöhle (draf typ ii): unter einem draf typ ii zugang versteht man die erweiterung des natürlichen zuganges zur stirnhöhle mit entfernung des bodens der stirnhöhle zwischen der lamina papyracea zur augenhöhle und der mittleren nasenmuschel. (b): beidseitige fronto-spheno-ethmoidektomie mit maximaler erweiterung des zuganges zur stirnhöhle (draf typ iii): unter einem draf typ iii verste. (c) beidseitige spheno-ethmoidektomie: abtragung des processus uncinatus, die eröffnung der kieferhöhle, die eröffnung des vorderen und hinteren siebbeinsystems und die eröffnung der keilbeinhöhle.

(a): beidseitige fronto-spheno-ethmoidektomie mit erweiterung des natürlichen zuganges zur stirnhöhle (draf typ ii): unter einem draf typ ii zugang versteht man die erweiterung des natürlichen zuganges zur stirnhöhle mit entfernung des bodens der stirnhöhle zwischen der lamina papyracea zur augenhöhle und der mittleren nasenmuschel. (b): beidseitige fronto-spheno-ethmoidektomie mit maximaler erweiterung des zuganges zur stirnhöhle (draf typ iii): unter einem draf typ iii verste. (c) beidseitige spheno-ethmoidektomie: abtragung des processus uncinatus, die eröffnung der kieferhöhle, die eröffnung des vorderen und hinteren siebbeinsystems und die eröffnung der keilbeinhöhle.

Eligibility criteria:
inclusion criteria: * symptomatic crswnp patients without improvement after conservative treatment for at least 6 months extent of disease at least davos polyp score ≥ 4 points age 18-65 years signed consent exclusion criteria: * previous sinunasal surgery high resolution paranasal sinus ct shows other pathology (e.g. mucocele) incapable of judgement
effectiveness of kerastat gel for improved cosmesis of partial thickness burns

Conditions: Partial-thickness Burn

Summary: a randomized, controlled, 30-subject, within-subject trial for examining the effectiveness of kerastat gel, as opposed to the institutional standard of care, silver sulfadiazine, in improving cosmesis of the healed wound.

the study seeks to determine whether the use of kerastat gel as the primary dressing for partial thickness burns results in improved cosmesis of the healed wound, and results in less painful dressing changes, faster reepithelialization, and reduction in need for excision and grafting. the study will enroll 30 subjects. the study design is a randomized, controlled, within-subject trial to compare the effectiveness of kerastat gel vs. standard of care (soc), silver sulfadiazine (ssd). each of two distinct burns will be randomized to the use of kerastat gel or soc. patients will be seen weekly for the first month and then at months 3, 6, and 12 post burn.

Eligibility criteria:
inclusion criteria: * presenting with at least two comparable, discrete, and separate partial thickness thermal burns, as determined by the investigator, measuring 50 - 1,000 cm2 each * study wounds identified are partial thickness depth * kerastat gel and ssd can be applied to randomized study burn wounds as definitive care treatment within 24 hours from time of injury\] * overall total body surface area burned \< 20% exclusion criteria: * pregnant or nursing * prisoner * presence of inhalation injury, as determined by the investigator * injury requiring formal intravenous fluid resuscitation * concomitant non-thermal traumatic injuries * chronic medical conditions including, but not limited to, documented renal impairment (cr \> 2.5 mg/dl), hepatic impairment (total bilirubin \> 2.5 mg/dl), thromboembolic disorders, active infection in study wound areas, uncontrolled diabetes (hba1c \> 7%), hiv infection, history of melanoma or systemic malignancy within the last 10 years * receiving corticosteroids, immunosuppressive agents, radiation or chemotherapy, topical growth factors, or any other medication the investigator feels will affect wound healing * not expected to live at least 13 months post-burn * received an investigational drug or biologic within 3 months prior to injury * previously treated with a skin graft at either of the treatment sites * chemical or electrical burn * known or documented allergy to sulfonamides * proposed study wounds are full thickness * any condition the investigator determines will compromise subject safety or prevent the subject from completing the study

Keywords: wound dressing keratin hydrogel burn dressing
hetrombopag for the treatment of chemotherapy-induced thrombocytopenia in adults with solid tumors.

Conditions: Chemotherapy-Induced Thrombocytopenia

Summary: the purpose of current study is to evaluate the efficacy and safety of hetrombopag for the treatment of chemotherapy-induced thrombocytopenia in patients with solid tumors.


Eligibility criteria:
inclusion criteria: 1. men and women, 18-75 years of age; 2. participant with a histologically or cytologically confirmed solid tumor receiving treatment with chemotherapeutic agents; 3. participant experienced thrombocytopenia and chemotherapy delay; 4. ecog performance status 0-1; 5. adequate liver function; aspartate aminotransferase (ast) and alanine aminotransferase (alt) \< 3.0 x uln for participants without liver metastases or 5.0 x uln for participant with liver metastases); 6. adequate renal function; serum creatinine \< 1.5 x uln or egfr≤60 ml/min（cockcroft-gault） exclusion criteria: 1. participant has any history of hematologic diseases other than chemotherapy-induced thrombocytopenia; 2. participant has serious bleeding symptoms; 3. history of allergy to the study drug; 4. participant with hiv; 5. pregnant or lactating women; 6. participant has received any experimental therapy within 4 weeks prior to screening 7. other conditions that may affect participant's safety or trial evaluations per investigator's discretion
perioperative lactate kinetics in patient undergoing major liver surgery

Conditions: Liver Failure, Acute

Summary: major liver surgery is associated with increased incidence of perioperative complications and increased mortality if these are not addressed quickly in a high dependency intensive care unit. of these, posthepatectomy liver failure (phlf) represents one of the most important cause of postoperative unfavourable outcome. the present study investigates the correlation between lactate levels and phlf. lactate levels were collected at six specific timepoints: preoperative, pre-dissection phase, post-dissection phase, end of surgery and 24-hours and 48-hours in the postoperative period.


Eligibility criteria:
inclusion criteria: * patients undergoing major liver surgery for primary or secondary tumours exclusion criteria: * unsigned patient consent * death within 24 hours * need for perioperative renal replacement therapy * underlying liver disease (e.g. liver cirrhosis) * other causes of raised lactate levels (e.g. shock)