Kornimate/medical-research-clean huggingface dataset:
clinical research platform on decision making and clinical impact of biomarker-driven precision oncology

Conditions: Advanced Solid Tumors or Hematologic Malignancies

Summary: the retrospective cohort study infinity will be an instrument to analyze the current practice of precision oncology in the real-world setting. it will provide insight into real-world biomarker-directed treatment of cancer patients not eligible for standard therapies. the study will retrospectively collect medical records' data of patients who received a targeted treatment based on a potentially actionable alteration or biomarker identified by molecular diagnostics. data of deceased patients will be included. the study will analyze how molecular test results guided clinical decision making. the compiled treatment and outcome data will be a valuable resource to analyze the use and effectiveness of targeted therapy approaches in biomarker-defined and entity-defined subpopulations of cancer patients. these signals might generate new insights and foster progress of targeted cancer treatment. the associated biomarker profiling module aims to set up a decentral biobank for future research on molecular alterations or central re-testing.


Eligibility criteria:
inclusion criteria: * advanced solid tumors (i.e. locally advanced, inoperable and/or metastatic) or hematologic malignancies not eligible for standard therapy options (i.e. without further treatment options with drugs approved for the specific indication based on the judgement of the treating physician) * started or completed at the documenting study site a non-standard targeted therapy based on an actionable alteration or biomarker identified by molecular diagnostics * results on molecular diagnostics (e.g. tumor genomic or protein expression test) must be available; based on these results the therapy decision was taken * targeted therapy (given as monotherapy or as part of a therapy regimen) must be non-standard at time point of patient registration in the ecrf * age ≥ 18 years * signed and dated informed consent form (only if patient is alive at time of data entry into the project; not applicable for inclusion of deceased patients' data) exclusion criteria: * non-standard targeted therapy was given within a clinical trial * the targeted therapy was given in a line of treatment for which it is non-standard (e.g. treatment in first line instead of second line where it is approved); the targeted therapy is however in principle approved for the given entity * the targeted therapy was non-standard because a certain prior treatment has not been applied (e.g. targeted therapy is only approved after platin-based treatment but has been given without prior platin-based treatment); the targeted therapy is however in principle approved for the given entity * the targeted therapy was non-standard because a different or no chemotherapy back-bone has been applied (e.g. targeted therapy is approved in combination with cisplatin but has been given with oxaliplatin or without chemotherapy backbone); the targeted therapy is however in principle approved for the given entity
efficacy of intravenous iron administration in hemodialysis patients

Conditions: Chronic Renal Failure; Hemodialysis; Renal Anemia; Iron Deficiency Anemia

Summary: the purpose of this study is to determine whether the frequency of intravenous iron administration has an effect on anemia correction and oxidative stress formation in hemodialysis patients.

in patients who are on chronic hemodialysis (hd), anemia is a major complication and is associated with poor clinical outcomes. consequently, management of anemia by recombinant erythropoietin is reported consistently to improve outcome measures in hd patients. because iron is essential for hemoglobin formation, as is erythropoietin, most patients routinely receive iron intravenously (ivir) for anemia correction. although ivir has been shown to improve both survival and quality of life of hd patients, it has been suggested that ivir may enhance the generation of hydroxyl radicals in the body through the inflammation process and the fenton reaction. previously we demonstrated that that serum albumin is highly oxidized in hd patients and that ivir on these patients significantly increased the oxidation status of albumin. in 2004, the committee on the guidelines of the japanese society for dialysis therapy (jsdt) published the original japanese "guidelines for renal anemia in chronic hemodialysis patients". in the jsdt guidelines 2004, the committee recommended two ivir schedules for iron deficient patients; 1) administer 40 mg of iv iron at the end of dialysis session 3 times a week for 4 weeks (total 520 mg of iron), 2) administer 40 mg of iv iron at the end of dialysis session once a week for 3 months (total 520 mg of iron). both administration schedules are effective for the correction of iron deficiency and consequently for the amelioration of anemia. however, the effect of ivir frequency (three times a week vs. once a week) on the oxidative stress formation has not been investigated before. comparison: the two ivir schedules recommended by the jsdt guideline 2004 will be compared by measuring both hemoglobin and oxidized albumin in chronic hd patients.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of chronic renal failure * clinical diagnosis of iron deficiency anemia * must be on regular hemodialysis exclusion criteria: * allergic to intravenous iron administration

Keywords: intravenous iron administration
colchicine plus phenolic monoterpenes to treat covid-19

Conditions: COVID-19

Summary: in this randomized controlled clinical trial, defined cases of covid-19 with mild, moderate, or severe pneumonia (according to the nih guideline) were treated with conventional treatment regimens (controls) as well as in combination with oral administration of colchicine plus herbal phenolic monoterpene fractions (intervention arm). after randomization, each group received the mentioned treatments and were evaluated for different variables including mortality, hospitalization duration, intensive care unit (icu) administration ratios as well as laboratory variables such as leukocytes and lymphocytes count. the follow-up period considered as 2 weeks after discharge. the mentioned variables were assessed as before and after receiving the treatment in each group as well as intergroup analysis for comparing both baseline and final values.


Eligibility criteria:
inclusion criteria: * defined cases of covid-19 based on laboratory and/or radiological and clinical manifestation exclusion criteria: * age \<10, pregnancy, sever kidney dysfunction, previous history of allergy to colchicine, not willing to sign informed consent form

Keywords: covid-19 colchicine phenolic monoterpenes
treatment of chronic anemia with epoetin alfa in elderly

Conditions: Anemia

Summary: the purpose of this study is to determine if chronic anemia can be corrected with epoetin alfa and does the subsequent correction lead to an improvement in fatigue,quality of life or mobility among elderly.

chronic anemia is common among elderly. given their somewhat non-specific nature, the clinical symptoms of anemia are often difficult to attribute directly to the anemia itself. however, it is known that anemic older adults are at an increased risk of mortality, disability, higher risk of falls, poorer quality of life, worsening cognitive function, increase hospitalization risk, and increased healthcare utilization than their non-anemic counterparts. yet so far, there have been no treatment studies to demonstrate the benefits of correction of chronic anemia. epoetin alfa (procrit) is a manufactured form of a naturally occurring hormone that is given as an injection by a medical professional to stimulate the bone marrow's production of red blood cells. this study is to explore, can chronic anemia be corrected with epoetin alfa and does the subsequent correction lead to an improvement in fatigue, quality of life or mobility among elderly. overall this is a 32 week treatment study. in this study, participants with chronic anemia will receive either epoetin alfa or placebo (saline injection) under the skin for 16 weeks. after 16 weeks the participants who were receiving epoetin will be switched to placebo and those who were receiving placebo earlier will go on now to receive epoetin alfa for 16 weeks. at the end of 32 weeks we will compare, if epoetin alfa corrected the anemia, how individuals felt in respect to their fatigue levels, quality of life and did mobility improve during the study.

Eligibility criteria:
inclusion criteria: * 65 years of age or older diagnosed with chronic anemia hemoglobin level less than or equal to 11.5 g/dl community dwelling able to make monthly clinic visits exclusion criteria: * currently on epoetin alfa or similar preparations having nutritional anemia having active cancer or received recent treatment for cancer on treatment for kidney disease diagnosis of dementia inability to ambulate

Keywords: chronic anemia anemia chronic diseases elderly epoetin alfa fatigue quality of life mobility
audiovisual assessment after dural puncture during epidural placement in obstetric patients

Conditions: Hearing Loss

Summary: the study involves assessment of hearing and visual complications along with headache after accidental dural puncture in patients receiving epidurals. hearing loss will be assessed by clinical examination and audiometry testing, while visual complications will be assessed by clinical examination. the patients will receive standard treatment for headache in the form of drugs and if required an epidural blood patch ( injecting patient's blood in the epidural space). the course of these complications and response to treatment will be investigated over a period of time. audiometry results from patients with dural puncture will be compared to those of patients who also had epidurals, but without a dural puncture. the investigators hypothesize that audiovisual complications occur more frequently in patients having accidental dural puncture with epidural needle and that the symptoms resolve with the administration of epidural blood patch.

although many studies have reported auditory complications after spinal, none have been done in obstetric patients with accidental dural puncture with epidural needle. long term follow up of these complications has been unknown. the incidence of both auditory and visual complications is likely to be high in patients getting accidental dural puncture with 17g touhy epidural needle as compared to small gauge spinal needles. several case reports have been reported with such temporary and permanent hearing and visual loss. a prospective study to understand these complications is required. the study will provide us with the true incidence of audiovisual complications of dural puncture with an epidural needle. early intervention in cases of dural puncture may alleviate or halt symptoms.

Eligibility criteria:
inclusion criteria: * parturients having accidental dural puncture during epidural placement for labour analgesia. * patients who give written informed consent to participate in the study. * dural puncture with 17g touhy needle with/out headache * postural headache after 24 hours of epidural * labouring women undergoing vaginal or cesarean delivery * for the control group, patients with no dural puncture during epidural placement exclusion criteria: * patients refusing to consent * dural puncture with spinal needle

Keywords: audiometry dural puncture epidural
stigma and psychological profile in rectal-anal cancer patients

Conditions: Rectal Cancer; Anal Cancer

Summary: in 2022, italy is estimated to have 48,100 cases of colon-rectum cancer. locally advanced mid-lower rectal cancers require preoperative chemo-radiotherapy with fluoropyrimidine. the diagnosis and treatment of rectal cancer have a significant impact on patients' well-being, causing physical and psychological distress. symptoms such as abdominal pain, fatigue, diarrhea, are commonly reported. while distress levels have been examined before, the relationship between other aspects of the patient experience, such as psychosocial factors, stigma, temperament and personality, alexithymia, have not been extensively explored. colorectal cancer is associated with specific socially stigmatized challenges. stigmatization is defined as societal identification of an individual as abnormal and worthy of separation, leading to discrimination and loss of social status. rectal cancer patients may perceive high levels of stigma and blame due to factors such as defecation-related symptoms, colonoscopy or rectal examinations, physical limitations, loss of work ability and the use of colostomy or ileostomy. anal cancer, although traditionally surrounded by social stigma, is gaining awareness worldwide due to increasing diagnoses. in other forms of cancer, stigma has been linked to personality traits. given the characteristics related to the illness and the profile of rectal and anal cancer patients, it is important to assess the psychological traits and psychological resources, also in order to establish tailored psychological pathways during the disease trajectory that comprehend chemoradiations and possible subsequent surgery. currently, there is no documented data on the relationship between stigma, and psychological profiles in rectal and anal cancer patients. aim of this protocol is to evaluate the stigma, and psychopathological profile in rectal and anal cancer patients and to evaluate changes in those variables over time.


Eligibility criteria:
inclusion criteria: locally advanced rectal and anal cancer patients undergoing a long course of radiotherapy * patients in chemo-radiation treatment * ability to understand and complete the questionnaires * age ≥18 years * informed consent signed exclusion criteria: * age \> 75 years * rectal and anal cancer patients undergoing short-course radiotherapy * rectal and anal cancer patients undergoing palliative radiotherapy * patients with inability to express informed consent * patients denying informed consent * patients with psychopathological disturbances preexisting to the cancer diagnosis * patients affected by severe language deficits
combined application of een in the induction of remission in puc

Conditions: Exclusive Enteral Nutrition; Ulcerative Colitis; Children

Summary: the role of exclusive enteral nutrition (een) in the induction of remission in pediatric patients with crohn's disease had been well documented. but the role of een in children with ulcerative colitis (uc) was not clear. in this study, een will be combined with corticosteroids or infliximab in the induction of remission in pediatric uc patients with moderate to severe disease activity. the mucosal healing rate at week12 will be compared between the two groups (combine with een group vs non-combine group).

the role of exclusive enteral nutrition (een) in the induction of remission in pediatric patients with crohn's disease(cd) had been well documented. several randomized controlled trial studies found that the overall induction of remission was equipotent with een compared to corticosteroids for pediatric cd. however, in promoting mucosal healing and improving the nutritional status, een was much better than corticosteroids. but the role of een in children with ulcerative colitis (uc) was not clear. in this study, een will be combined with corticosteroids or infliximab in the induction of remission in pediatric uc patients with moderate to severe disease activity. the mucosal healing rate at week 12 will be compared between the two groups (combine with een group vs non-combine group).the sustained corticosteroid-free clinical remission rate and treatment modification rate during the first year will also be evaluated.

Eligibility criteria:
inclusion criteria: 1. newly diagnosed uc 2. years 6 to 18 3. moderate to severe disease activity at diagnosis exclusion criteria: 1. with mild disease activity at diagnosis 2. had been treated with corticosteroids or biologics
a study of niraparib in combination with abiraterone acetate and prednisone versus abiraterone acetate and prednisone for treatment of participants with metastatic prostate cancer

Conditions: Castration-Resistant Prostatic Cancer

Summary: the purpose of this study is to evaluate the effectiveness of niraparib in combination with abiraterone acetate plus prednisone (aap) compared to aap and placebo.


Eligibility criteria:
inclusion criteria: * hrr gene alteration (as identified by the sponsor's required assays) as follows: 1. cohort 1: positive for hrr gene alteration 2. cohort 2: not positive for drd (that is, hrr gene alteration) 3. cohort 3: eligible by hrr status * metastatic disease documented by positive bone scan or metastatic lesions on computed tomography (ct) or magnetic resonance imaging (mri) * metastatic prostate cancer in the setting of castrate levels of testosterone less than or equal to (\<=) 50 nanogram per deciliter (ng/dl) on a gonadotropin releasing hormone analog (gnrha) or bilateral orchiectomy * able to continue gnrha during the study if not surgically castrate * score of \<= 3 on the brief pain inventory-short form (bpi-sf) question number 3 (worst pain in last 24 hours) exclusion criteria: * prior treatment with a poly (adenosine diphosphate \[adp\]-ribose) polymerase (parp) inhibitor * systemic therapy (that is, novel second-generation ar-targeted therapy such as enzalutamide, apalutamide, or darolutamide; taxane-based chemotherapy, or more than 4 months of abiraterone acetate plus prednisone \[aap\] prior to randomization) in the metastatic castration-resistant prostate cancer (mcrpc) setting; or aap outside of the mcrpc setting * symptomatic brain metastases * history or current diagnosis of myelodysplastic syndrome (mds)/acute myeloid leukemia (aml) * other prior malignancy (exceptions: adequately treated basal cell or squamous cell skin cancer, superficial bladder cancer, or any other cancer in situ currently in complete remission) \<= 2 years prior to randomization, or malignancy that currently requires active systemic therapy
effects of two in-hospital antepartum interventions on functional ability and quality of life in early postpartum women.

Conditions: High-Risk Pregnancy

Summary: the current standard of care for pregnant women deemed to be high-risk often involves recommending varying levels of activity-restriction, up to and including hospitalization. high levels of activity-restriction can lead to physical deconditioning of the mother, which can be difficult to recover from after birth. the proposed study will investigate whether a mild muscular conditioning program conducted in bed and given to hospitalized activity-restricted high-risk pregnant women will improve functional ability, cardiovascular deconditioning and overall quality of life in the postpartum period compared to a control group with no in hospital bed-rest exercise program. we hypothesize that women with a in-hospital muscle conditioning program will be better able to perform functional ability tasks and activities of daily living than a control group with no exercise program.


Eligibility criteria:
inclusion criteria: * hospitalized high-risk pregnant women in hospital for at least 7 days * diagnosed with gestational hypertension * diagnosed with preeclampsia (mild to moderate) * diagnosed with intrauterine growth restriction * single baby * expecting twins * expecting triplets * diagnosed with shortened cervix * diagnosed with threatened pre-term labour (not actively contracting) exclusion criteria: * diagnosed with symptomatic placenta previa (bleeding) * diagnosed with severe pre-eclampsia (immediate delivery) * diagnosed with conditions indicating a short term hospital stays of less than 7 days * diagnosed with infections * diagnosed with heart and renal disease * diagnosed with diabetes * diagnosed with metabolic bone disease * diagnosed with hyper-or-hypo-thyroidism * diagnosed with cushing disease and anemia * women carrying more than 3 babies

Keywords: hospitalized activity restriction bed rest antepartum pregnant high risk
surveillance of cardiovascular risk factors in cameroonian garrison

Conditions: Cardiovascular Risk Factor

Summary: purpose: the objective of our study was to assess the cardiovascular risk of a cameroonian military population and compare it to the cardiovascular risk of the neighboring civilian population. patients and methods: we will conduct a cross-sectional study that involved subjects aged from 18 to 58 years, recruited from october 2017 to november 2018 at the fifth military sector health center in ngaoundéré. data collection and assessment was done according to world health organization steps manual for surveillance of risk factors of non-communicable chronic diseases; and the alcohol use disorders identification test. five cardiovascular risk factors were assessed, smoking, harmful alcohol consumption, obesity/overweight, hypertension and diabetes. cardiovascular risk was considered high in subjects with three or more cardiovascular risk factors. univariates analysis and multivariate logistic regression were carried out according to their indications.


Eligibility criteria:
inclusion criteria: * agree to participate, * had to be aged between 18 and 58 years old, * representing ages of enrollment and retirement for cameroonian soldiers respectively. exclusion criteria: -

Keywords: prevention non-communicable disease cardiovascular diseases cardiovascular risk soldiers
a study to evaluate the efficacy and safety of hsk39297 in patients with paroxysmal nocturnal hemoglobinuria（pnh）

Conditions: Paroxysmal Nocturnal Hemoglobinuria (PNH)

Summary: this is a multicenter, randomized, open-label phase 2 study. adult patients with paroxysmal nocturnal hemoglobinuria naïve to complement inhibitor therapy were included. subjects were treated with hsk39297 for 24 weeks.


Eligibility criteria:
inclusion criteria: 1. male and female participants ≥ 18 years of age; 2. diagnosis of pnh based on flow cytometry with clone size \> 10% by granulocytes; 3. have not received complement inhibitor treatment; 4. blood lactate dehydrogenase(ldh) values \> 1.5 ×upper limit of the normal range (uln) ; 5. hemoglobin level \< 100 g/l during the screening period. exclusion criteria: 1. hereditary or acquired complement deficiency; 2. active primary or secondary immunodeficiency; 3. history of splenectomy, bone marrow/ hematopoietic stem cell or solid organ transplants; 4. history of recurrent invasive infections caused by encapsulated organisms( e.g. meningococcus or pneumococcus) or mycobacterium tuberculosis; 5. patients with laboratory evidence of bone marrow failure (reticulocytes \< 100x10\^9/l, or platelets \< 30x10\^9/l or neutrophils \< 0.5x10\^9/l) ; 6. active systemic infection within 2 weeks prior to study drug administration; 7. history of serious comorbidities that have been determined to be unsuitable for participation in the study. 8. pregnant or lactating women.