Kornimate/medical-research-clean huggingface dataset:
anlotinib with trastuzumab deruxtecan for previously treated her2-low advanced breast cancer

Conditions: Breast Cancer

Summary: this study will evaluate the safety, tolerability and efficacy of anlotinib and trastuzumab deruxtecan in human epidermal growth factor receptor 2 (her2)-low unresectable and/or metastatic breast cancer who had received ≤1 line of prior chemotherapy.


Eligibility criteria:
inclusion criteria: * 1. age 18 - 75 years; ecog ps 0 or 1. 2. pathologically documented breast cancer that: 1. is unresectable or metastatic. 2. has a history of low her2 expression (ihc 1+\& ihc 2+/ish- or 0\<ihc\<1+). 3. is hr-positive or hr-negative. 4. has progressed on, and would no longer benefit from, endocrine therapy. 5. has been treated with ≥1 prior lines of chemotherapy/adjuvant in the recurrent or metastatic setting. 3. at least 1 measurable lesion per response evaluation criteria in solid tumors version 1.1（previously treated lesions with radiotherapy or focal therapy and no progression cannot be included as target lesion for assessment）. 4. has protocol-defined adequate bone marrow, renal, hepatic and blood clotting functions. 5. male and female subjects of reproductive/childbearing potential must agree to use a highly effective form of contraception or avoid intercourse during and upon completion of the study and after the last dose for at least 6 months. exclusion criteria: 1. has previously been treated with anti-angiogenic targeted small molecule therapy. 2. prior treatment with antibody drug conjugate with a topoisomerase i inhibitor exatecan derivative. 3. has a history of (noninfectious) ild/pneumonitis that required steroids, has current ild/pneumonitis, or where suspected ild/pneumonitis cannot be ruled out by imaging at screening. 4. has unresolved toxicities from previous anticancer therapy. 5. has uncontrolled or significant cardiovascular disease. 6. has any bleeding event, unhealed wounds, ulcerative or fractures. 7. has arterial or venous thromboembolic events occurred within 6 months. 8. has spinal cord compression or clinically active central nervous system metastases. 9. has any other condition that per protocol or in the opinion of the investigator is inappropriate for the study.
non-interventional trial about treatment of haemorrhages in cholecystectomy with tachosil (tc-027-de)

Conditions: Hemorrhage

Summary: * effectiveness and reliability of tachosil in cholecystectomy (elective and acute) * evaluation of tachosil in laparoscopic cholecystectomy * risk profile of patient under anticoagulant therapy undergoing acute cholecystectomy * pharmaco-economic evaluation * recording of ae's/sae's considering the total number of cholecystectomies in germany (170.000 cases/y), out of them about 75% laparoscopic and 10.000 conversions totally it seems urgent to record data about usage of tachosil in such procedures. for the time being tachosil is applied in about 2% of the gall bladder procedures. aim is to evaluate a possible patient and procedure profile where tachosil is most beneficial.


Eligibility criteria:
inclusion criteria: * patients undergoing elective or acute cholecystectomy * the only restrictions of use will be those resulting from the contraindications (see section 4.3 of the summary of product characteristics)

Keywords: patients undergoing elective or acute cholecystectomy
phase-1 study of folinic acid to modulate mgmt gene in glioblastoma

Conditions: Grade IV Astrocytoma; Glioblastoma

Summary: o6-méthylguanine méthyltransférase (mgmt) is the main repair gene after dna lesion induced by temozolomide in combination with radiation therapy of glioblastoma (gbm) in stupp.r et al published regimen. in preclinical models, it has been demonstrated that mgmt methylation (which is silencing the dna repair process) is achievable by folic acid. about half of the patients with operated gbm have an un-methylated mgmt gene status and therefore a poorer prognosis. a phase-1 dose escalation study is proposed with pharmacologic doses of folinic acid in combination with temozolomide and radiotherapy of operated gbm.

glioblastoma treated by stupp regimen (temozolomide + radiation therapy) have a different outcome depending on the methylation status of mgmt gene: when the gene is unmethylated, the repair process is active and the prognostic poor. in pre-clinical models, it has been demonstrated that folic acid could re-methylate the mgmt gene and therefore the repair process to radiation and temozolomide could be limited, allowing a better prognosis. the proposed phase-1 study will explore the safety and efficacy of escalated doses of oral folinic acid concomitantly with stupp regimen. to determine the mtd is the main objective of the study, then the toxicty profile, the rdp2 and the methylation process efficacy at the mgmt gene level.

Eligibility criteria:
inclusion criteria: * operated gbm (complete or near complete resection) * un-methylated mgmt gene exclusion criteria: * non operable gbm * methylated mgmt

Keywords: high-grade glioma epigenetic
late evening supplementation with branched chain amino acids in liver transplantation

Conditions: Liver Cirrhosis

Summary: assess the impact in body composition and handgrip strength of the nocturne supplementation by a month with bcaa (enterex hepatic in patients awaiting liver transplantation)

clinical trial study was make, data were obtained from people awaiting liver transplantation and with at least a criteria of protein/energy malnutrition (fase angle \< 5.4°, subjective global assessment b or c and/or handgrip strength \< 30 in men and \< 20 in women). the investigators make them body composition assessment (weight, height, body mass index \[bmi\], mean arm circumference \[mac\], muscle arm area \[maa\], tricipital skinfold, dual x ray absorptiometry \[fat mass and fat free mass\]) and handgrip strength at beginning and after 30 days of nocturne supplementation with bcaa and standardized diet (35-40 kcal, 55% carbohydrates, 25% lipids and 20% proteins).

Eligibility criteria:
inclusion criteria: * patients on waiting list for liver transplantation. * diagnosis of undernutrition. exclusion criteria: * hepatorrenal syndrome. * hepatopulmonar syndrome * diabetes * overweight

Keywords: liver transplantation liver cirrhosis branched chain amino acids late evening supplementation nutritional status
complement regulatory proteins expression and clinical response in rheumatoid arthritis (ra) patients treated with rituximab

Conditions: Rheumatoid Arthritis

Summary: there is a correlation between the cd55, cd59, cd35 and cd46 expression on b lymphocytes of patients before and after treatment with rituximab and the level of depletion and repopulation time for these cells. the theoretical rationale of the study assumes that the correlation, if any, will be a negative correlation. however, the hypothesis of positive correlation (two-tailed test) will also be tested.

rituximab, an anti-cd20 monoclonal antibody, is a new alternative treatment for patients with severe immune diseases and resistance to conventional treatment. one of the mechanisms of action of this drug is the complement-mediated lysis. most ra patients respond well to rituximab treatment, however, some are refractory and mechanism of this non-response is still unclear. the role of cd55 and cd59 protein and its overexpression as a mechanism of resistance to rituximab treatment in lymphoma patients have been investigated. however, there has not been studied a correlation between the intensity of expression of these regulatory molecules on b cells of ra patients and resistance to treatment with rituximab.

Eligibility criteria:
inclusion criteria: 1. patients of both gender, aged greater than or equal to 18 years; and lower than 70 years. 2. patients diagnosed with ra for at least 6 months according to the criteria of the american college of rheumatology (acr) in 1987 for classification of ar. 3. patients with a medical indication for therapy with rituximab, with prescription of this therapy for the first time and have not yet received the first dose. 4. das28 score greater than or equal to 3.2. 5. use of adequate contraception, as judged from the attending physician. 6. desire to participate voluntarily, the ability to understand the protocol, documented by signing the consent form (attached). exclusion criteria: 1. overlapping rheumatic disease, autoimmune lymphoproliferative and neoplastic. 2. active infection, patients with the use of cytotoxic drugs, presence of positive serology for hcv, hbv and hiv, active or latent tuberculosis. 3. allergy or hypersensitivity to rituximab. 4. pregnant woman or performing breastfeeding. 5. participating in another clinical study with intervention. 6. with functional class iv defined based on the criteria of steinbrocker functional classification for ra. 7. prior therapy with rituximab.

Keywords: rituximab, rheumatoid arthritis, cd55, cd59
folic acid interferes with radiation esophagitis

Conditions: Lung Cancer

Summary: this randomized study compared the incidence and severity of radiation esophagitis with folic acid and with conventional symptomatic treatment.

by prospective randomized controlled study, this study research plans to recruit with diagnosis of lung cancer patients, according to whether there is drug intervention were divided into treatment group and control group, compared two groups of acute radiation esophagitis in the before and after the intervention, extent of occurrence of folic acid and clinical curative effect, so as to verify whether folic acid can be used as an intervention in the treatment of radioactive esophagitis, to explore the safety of folic acid in the treatment of radioactive esophagitis and explore the standardized treatment of radioactive esophagitis.

Eligibility criteria:
inclusion criteria: 1. patients with malignant lung cancer (incluedig non-small cell lung cancer, small cell lung cancer) diagnosed by histopathology or cytology. 2. tnm stage n2\~n3 (iaslc international tnm staging standard for lung cancer, 8th edition) was indicated by radiotherapy and the patients were treated for the first time. 3. aged between 18 and 75 years old,no limit on the gender. 4. ecog≤2 or kps≥70. 5. no contraindication of concurrent chemoradiotherapy. 6. patients without important organ dysfunction,hematology: it is within the normal range according to the standards of each laboratory; cardiac function: normal range; liver function: normal range; renal function: normal range; pulmonary function: fev1 \> 50%, mild to moderate impairment of pulmonary function. 7. patients with good compliance to treatment received and follow-up. exclusion criteria: 1. prior to treatment, there were other esophageal diseases, such as gastrointestinal ulcer, reflux esophagitis, cardia relaxation. 2. patients with severe nutritional anemia prior to treatment. 3. the iv stage patients with uncontrolled malignant pleural effusion,with diffuse liver or lung metastasis which lead to liver or pulmonary dysfunction. 4. patients with severe heart, lung or kidney diseass,such as uncontrolled hypertension, diabetes, unstable angina, a history of myocardial infarction or heart failure, or uncontrolled arrhythmias; there is clearly clinically diagnosed heart valve disease; the active phase of a bacterial, fungal, or viral infection; mental disorders; severely impaired lung function. 5. a history of previous tumors complicated with other malignant tumors. 6. the pregnant or breast-feeding patients. 7. patients with mental and neurological diseases.
the efficiency of using supportive postures and holding techniques to minimize premature infant pain (pap)

Conditions: Premature Infant

Summary: out of the most commonly performed procedures in neonates, naso-gastric tube insertion is rated as the fifth most painful. the pain is often under estimated due to the frequency with which the procedure is carried out. it has been shown that the environment in which the procedure is performed (e.g with skin to skin contact and specific positioning), reduces the discomfort felt by the newborn. however, this has not yet been proven with regards to naso-gastric tube insertion.

our clinical study (carried out in the neonatology unit of mercy regional hospital) has shown that when positioning and other non drug related analgesic techniques are used, newborns undergoing naso-gastric tube insertion feel less pain. several different techniques were used, such as skin-to-skin contact with the mother and/or positioning the infant using appropriate equipment, or the "four hands" technique carried out by two health care professionals. neonatal unit staff were able to choose the method used depending on whether the mother was present at the time of the procedure. in cases where the mother was absent, the "four hands technique" was favored, but in the presence of the mother skin-to-skin contact was preferable.

Eligibility criteria:
inclusion criteria: * preterm baby born between the 32th and the 35th weeks of amenorrhea plus 6 days * prescription of enteral nutrition via naso-gastric tube * naso-gastric tube in-situ * informed consent of both parents exclusion criteria: for the newborn * under respiratory assistance * with nasal or buccal malformation * with abnormal heart rhythm or congenital heart disease * with hemodynamic instability * transfer to type 3 neonatal unit * with a dan score \> 0 before treatment * with an umbilical venous catheter in-situ * fed with thickened milk * prescription of analgesic medications for the parents * minor * under legal protection * difficulties which do not permit the mother to carry out skin-to skin contact or holding support

Keywords: pain naso-gastric tube
subcutaneous testosterone replacement efficacy and safety in adult men diagnosed with hypogonadism

Conditions: Hypogonadism

Summary: evaluation of efficacy and safety of testosterone enanthate administered subcutaneously using an auto-injector

this study will evaluate, if testosterone enanthate administered subcutaneously once each week by an auto-injector to men with low testosterone, can raise their levels into the normal range. the study will investigate the ability to adjust testosterone enanthate dose levels using single point blood concentrations. safety and tolerability of testosterone administration will be evaluated along with the patient's ability to use the auto-injector and follow the instructions for auto-injector use.

Eligibility criteria:
inclusion criteria: * adult males aged ≥ 18 year of age with a documented diagnosis of hypogonadism * total testosterone levels \< 300 ng/dl at two qualification visits * patients in good general health exclusion criteria: * allergy to sesame or testosterone products * bmi ≥ 40 kg/m2 * hematocrit ≥ 52% * history or current evidence of breast or prostate cancer * elevated psa (prostate-specific antigen) for age. * abnormal dre (digital rectal examination) * obstructive uropathy of prostatic origin * poorly controlled diabetes * congestive heart failure * within 6 months of screening, mi (myocardial ischemia), unstable angina leading to hospitalization, percutaneous coronary intervention, coronary artery bypass graft, uncontrolled cardiac arrhythmia, stroke transient ischemia attack, ceratoid revascularization, endovascular procedure, or surgical intervention for peripheral vascular disease. * history or current treatment of thromboembolic disease. * use of acth (adrenocorticotropic hormone) or oral/depot corticosteroids within 6 weeks of screening. * history of severe, untreated sleep apnea * subjects with any clinically significant medical condition which, in the opinion of the investigator, would make the subject an unsuitable candidate for enrollment in the study * positive serology for hiv, hepatitis b or hepatitis c * current evidence of drug or alcohol abuse. * skin conditions in injection site that could confound injection site assessments. * administration of other investigational compounds within one month of screening or 5 half-lives of the investigational compound, whichever is longer). * use of estrogen, gnrh (gonadotropin-releasing hormone) or growth hormone within 12 months of screening. * use of other androgens (dhea(dehydroepiandrosterone), anabolic steroids, other sex hormones) or other substances/supplements know to affect the pk (pharmacokinetics) of testosterone enanthate * considered or scheduled surgical or dental procedures associated with blood loss ≥500 ml during study. * donation of plasma or blood within 56 days of screening or history of donation of \> 50 ml of blood or plasma within 3 months of screening. * donation of plasma or blood during study

Keywords: hypogonadism testosterone enanthate
effectiveness of malaria camps as part of the odisha state malaria elimination drive

Conditions: Malaria

Summary: the odisha state malaria control program (india) has introduced 'malaria camps' where teams of health workers visit villages to educate the population, enhance vector control with long-lasting insecticide nets (llins) and indoor residual spraying (irs), and perform village-wide screening with rapid diagnostic tests and treatment for malaria. the long-term goal of this project is to evaluate the effectiveness of malaria camps (mcs) by determining if they reduce malaria, and to characterize malaria transmission in mcs.

the persistently high malaria burden in the remote forested areas of odisha, india has led to the introduction of 'malaria camps' by the odisha state malaria control program where teams of health workers visit villages to educate the population, enhance vector control with long-lasting insecticide nets (llins) and indoor residual spraying (irs), and perform village-wide screening with rapid diagnostic tests and treatment for malaria. the camps appear to be very effective but this is hard to assess in the context of ongoing changes such as llin introduction. the long-term goal of this project is to evaluate the effectiveness of malaria camps (mcs) by determining if they reduce malaria, and to characterize malaria transmission in mcs. the major objective to achieve this is through a quasi-experimental study (i.e., pretest-post-test control group design) of the effectiveness of the intervention, to determine if mcs reduce the prevalence of clinical and asymptomatic malaria as detected by pcr. in the first year, villages will be assigned across three study arms: arm 1 to receive new mcs; arm 2 is a control with no mcs but with standard malaria control; and arm 3 consists of villages already in receipt of mcs to study longer term effects. in the second year, both arm 1 and arm 2 villages will receive the intervention (i.e., a non-randomized stepped-wedge design). mc effectiveness will be evaluated from epidemiologic surveys and pcr detection of malaria prevalence with and without mcs.

Eligibility criteria:
inclusion criteria: * written informed consent by individuals greater than 17 years old, or consent by a parent/guardian of children 1-6 years old, or assent of individuals from 7-17 years old along with consent from his or her parent or legal guardian. * a complete understanding of study procedures/protocols, as delineated in the consent and assent forms and information sheets. * individuals have the ability and are willing to comply with study procedures for the entire length of the study. exclusion criteria: * individuals less than 12 months or more than 69 years of age will be excluded. * persons who do not understand the study or are physically unable to make monthly visits.
the use of virtual reality applications in tension-type headaches

Conditions: Headache; Analgesia; Tension-Type Headache

Summary: the primary aim of this research is to objectively assess the impact of virtual reality (vr) technology on pain symptoms in tension-type headache patients. this study is designed to understand the potential of vr in the treatment of tension-type headaches, exploring its ability to reduce pain severity and improve patients' quality of life.

tension-type headache is a prevalent health issue that can cause significant discomfort to patients. the potential use of vr goggles as an effective alternative treatment option in these patients is crucial in clinical applications. the quality of life of tension-type headache patients is often affected. if vr goggle technology can enhance the quality of life for these patients, it would be a significant finding. additionally, our research may contribute more data to the scientific literature on the impact of vr goggle technology in headache treatment. this could assist future researchers in designing similar studies and better understanding the results. if vr goggle technology proves effective, it could contribute to diversifying treatment options for tension-type headache patients and improving access to treatment. the primary objective of the study is to investigate the effect of virtual reality therapy on pain symptoms in tension-type headache patients. if the results are positive, vr technologies may alleviate pain and enhance the quality of life for these patients. it could also help them function better in their daily lives. if relaxation is found to be effective in the vr group, a new treatment option would be introduced for tension-type headache patients. this could contribute to the diversification of treatment options. the study poses no risk to the patient. the patient will lie on the bed, and the vr goggles will be used accordingly.

Eligibility criteria:
inclusion criteria: * patients between the ages of 18 and 65 * patients meeting the criteria for tension-type headache (tth) in the third edition of the international classification of headache disorders * patients willing to participate in the study * patients indicating a vas score of 50 and above * patients without other suspected diagnoses * patients with no known history of adverse reactions to the active ingredients of the drugs to be used * conscious patients * patients who are oriented and cooperative exclusion criteria: * patients under the age of 18 and over the age of 65 * patients who do not consent to participate in the study * patients with vital signs outside normal limits * patients with a history of adverse reactions to known nsaids * individuals unable to determine pain intensity on the vas * patients with a vas score of 50 mm and below * pregnant individuals * those with advanced systemic diseases * patients with malignancies * individuals with chronic liver and kidney diseases * those using sedative and analgesic neuro-psychiatric drugs * individuals with a history of psychological and neurological diseases * patients who used analgesics within 8 hours before the examination