Kornimate/medical-research-clean huggingface dataset:
topotecan in combination with pemetrexed in patients with advanced malignancies

Conditions: Ovarian Cancer; Endometrial Cancer; Cervical Cancer; Lung Cancer

Summary: currently, no data exists regarding the safety and tolerability of a combination regimen utilizing weekly topotecan in combination with pemetrexed. although both drugs are associated with myelosuppression, it is hoped that the utilization of the weekly topotecan dosing schedule will allow the drugs to be easily combined. this phase i trial will evaluate the safety and tolerability of weekly topotecan in combination with pemetrexed in patients with advanced solid tumors.

three patients will be accrued at each of 5 dose levels. dose escalation will only proceed if none of the additional 3 patients experience dlt. the highest dose level that generates dlt in 0/3 or 1/6 patients will be the maximum tolerated dose (mtd) or the doses recommended for subsequent studies. a total of 10 patients will be treated at the mtd to further assess the toxicity of the dosing regimen and its suitability for use in subsequent trials. patients may continue to receive treatment until unacceptable toxicity or disease progression is encountered. treatment cycles will be repeated every 21 days. the protocol is also designed to enroll an additional 10 patients at the maximum tolerated dose to increase the confidence in the safety and suitability of the doses that are chosen for subsequent studies. * topotecan day 1 and 8 * pemetrexed day 1

Eligibility criteria:
inclusion criteria: * histologically proven advanced solid tumors * measurable or evaluable disease * age ≥ 18 years * karnofsky performance status ≥ 80% (ecog 0 or 1) * adequate liver, bone marrow and kidney function exclusion criteria: * more than 3 prior chemotherapy regimens in the metastatic setting * prior treatment with topotecan or pemetrexed * clinically significant third space fluid present at the time of treatment * unable to interrupt aspirin, other non-steroidal anti-inflammatory drugs * inability to take steroid premedications or vitamin supplementation * the presence of active brain metastases * prior radiotherapy within 4 weeks prior to the first day of treatment * prior surgery within 3 weeks prior to the first day of treatment * prior chemotherapy within 3 weeks prior to the first day of treatment

Keywords: ovarian carcinoma endometrial carcinoma cervical carcinoma lung carcinoma
intralipid therapy for recurrent implantation failure and recurrent miscarriages: is it a hope or myth?a randomized clinical trial

Conditions: Pregnancy Complicated by Low Implantation

Summary: both organ-specific and systemic autoimmunity are associated with an increased prevalence of recurrent miscarriage and reproductive failure, rendering the role of the maternal immunological system in fertility a key concept. it is believed by some that central to this theme is the maternal cytokine profile, with particularly t-helper (th) cells. immune modulating therapies have therefore been mooted as potential therapeutic strategies. recent reports of high pregnancy rates achievable in women with rif have added fuel to the debate regarding the effectiveness of intralipids in modulating the immune system.

the investigators would like to assess if that intralipids therapy is an effective treatment for women undergoing repeated failed assisted reproduction cycles and recurrent miscarriages against traditional methods in randomised clinical trial (rct).

Eligibility criteria:
inclusion criteria: 1. recurrent unexplained failed ivf, icsi. 2. recurrent unexplained miscarriages. 3. high level of peripheral and uterine nk. exclusion criteria: 1. age above forty years old. 2. antiphospholipid syndrome (lupus anticoagulant and/or anticardiolipin antibodies \[igg or igm\]); other recognised thrombophilic conditions (testing according to usual clinic practice). 3. intrauterine abnormalities (as assessed by ultrasound, hysterosonography, hysterosalpingogram, or hysteroscopy). 4. fibroids distorting uterine cavity. 5. abnormal parental karyotype. 6. other identifiable causes of recurrent miscarriages (tests initiated only if clinically indicated) e.g., diabetes, thyroid disease and systemic lupus erythematosus (sle).

Keywords: implantation failure recurrent abortion intralipid
tbtc study 23: treatment of hiv-related tuberculosis using a rifabutin-based regimen

Conditions: HIV Infections; Tuberculosis

Summary: primary objective: to determine the rate of confirmed treatment failure and relapse with an intermittent rifabutin-based regimen for the treatment of isoniazid and rifamycin-susceptible hiv-related tuberculosis (tb).


Eligibility criteria:
inclusion criteria * clinical diagnosis of pulmonary \&/or extrapulmonary tb confirmed by a positive culture and susceptibility to rifampin. patients having isoniazid or pyrazinamide (pza)-resistant isolates are eligible to continue in the study on a modified regimen * evidence of hiv infection confirmed by a positive serologic test (elisa and western blot). * absolute neutrophil count \>500/mm3 (use of colony stimulating factors, filgrastim, or sargramostim is allowed) * \> 18 years of age * willingness to practice effective contraception if applicable * signed informed consent exclusion criteria * pregnancy or breastfeeding * ast \> 10 times the upper limit of normal * bilirubin \> 3.0 times the upper limit of normal * creatinine \> 3.0 times the upper limit of normal * intolerance to any of the study drugs except isoniazid or pyrazinamide * concomitant disorder that is contraindication to the use of the study drugs * more than 28 days of treatment for active tuberculosis within the 6 months prior to this course of therapy * bone/joint tuberculosis or silicotuberculosis

Keywords: tuberculosis tb
effect of oral vitamin d3 on chronic rhinosinusitis treatment in adults with lower vitamin d levels

Conditions: Chronic Rhinosinusitis With Nasal Polyps

Summary: the purpose of the study is to test the clinical efficacy of oral vitamin d3 on wound healing in patients with chronic rhinosinusitis with nasal polyposis and lower vitamin d levels after endonasal endoscopic sinus surgery


Eligibility criteria:
inclusion criteria: * 1. clinical diagnosis of chronic rhinosinusitis with nasal polyps 2. be 18-60 years old of chinese people and of either sex，the han nationality 3. vitamin d level of less than 30 ng/ml exclusion criteria: * 1. women must not be pregnant, breast feeding 2. chronic oral corticosteroid therapy 3. history of physician-diagnosed nephrolithiasis 4. chronic diseases（ diabetes，hypertension，renal insufficiency, severe liver disease） 5.prior surgeries of the paranasal sinuses 6. with an upper respiratory tract infection within 4 weeks of entering the study
a study in adults with grass pollen-induced rhinoconjunctivitis

Conditions: Allergy

Summary: this is a 2 year clinical study to compare 5-grass mix slit-drops with placebo in relieving grass pollen-induced rhinoconjunctivitis symptoms and in use of symptom-relieving medication during the second grass pollen season (peak grass pollen season, pgps) the study will collect health-related quality of life data in the groups treated with 5-grass mix slit-drops or with placebo during the first and second pgps. the trial medication used is already approved to treat allergic rhinitis caused by grass pollen in adults in several countries.

this trial is a 2 year, parallel-group, double-blind, placebo-controlled phase iii trial to evaluate efficacy and safety of the 5-grass mix slit-drops in adults with grass pollen-induced rhinoconjunctivitis with or without asthma. approximately 440 adults will be enrolled in the trial and will receive the 5-grass mix slit-drops or placebo. the trial is conducted in several european countries.

Eligibility criteria:
inclusion criteria: 1. male or female aged ≥18 years on the day informed consent is obtained 2. a clinical history of grass pollen-induced allergic rhinoconjunctivitis for two years or more with or without asthma 3. a clinical history of severe allergic rhinoconjunctivitis symptoms (interfering with usual daily activities or sleep) induced by grass pollen, which remain troublesome despite symptomatic treatment with antihistamines, nasal steroids or eye drops during the previous grass pollen season 4. positive specific immunoglobulin e (ige) (defined as ≥class 2, ≥0.70 ku/l) against grass: phleum pratense 5. positive skin prick test to phleum pratense at screening exclusion criteria: 1. has a clinically relevant history of symptomatic seasonal and/or perennial allergic rhinoconjunctivitis and/or asthma caused by an allergen other than grass pollen, to which the subject is exposed, which could potentially overlap with the efficacy assessment periods 2. within the last 3 months before the randomisation visit, has had an occurrence of any clinical deterioration of asthma that resulted in emergency treatment, hospitalisation, or treatment with systemic corticosteroids 3. slit treatment with any grass pollen ait for more than 1 month within the last 5 years. in addition, any slit treatment with grass pollen ait within the previous 12 months 4. scit treatment with any grass ait reaching the maintenance dose within the last 5 years. in addition, any scit treatment with grass ait within the previous 12 months 5. ongoing treatment with any allergy immunotherapy product 6. uncontrolled or severe asthma requiring daily use of more than 800 mcg budesonide or equivalent at screening

Keywords: allergic rhinoconjunctivitis adults grass
clopidogrel as adjunctive reperfusion therapy - thrombolysis in myocardial infarction

Conditions: Acute Coronary Syndromes

Summary: the purpose of this study is to determine if the combination of aspirin plus clopidogrel is more effective than aspirin alone in preventing another heart attack, chest pain, stroke or death in people who have already had a heart attack that was treated with fibrinolytic therapy.


Eligibility criteria:
inclusion criteria: * stemi within 12 hours of randomization * planned treatment with a fibrinolytic agent and aspirin exclusion criteria: * intention of performing coronary angiography within 48 hours of fibrinolysis * treatment with clopidogrel or ticlopidine within 7 days prior to enrollment, or planned treatment with clopidogrel or ticlopidine. * contraindication to fibrinolysis * planned use of a glycoprotein iib/iiia inhibitor * prior cabg * evidence of cardiogenic shock or acute pulmonary edema requiring intubation or an intraaortic balloon pump * known renal or hepatic insufficiency
the combined use of prp with lipoaspirate and/or bone marrow aspirate in osteoarthritis

Conditions: Osteoarthritis

Summary: to demonstrate the efficacy of the combined use of platelet-rich plasma (prp) with lipoaspirate and/or bone marrow aspirate in osteoarthritis of major joints, and to compare the outcomes achieved using three combinations: prp plus lipoaspirate, prp plus bone marrow aspirate, and prp plus both lipoaspirate and bone marrow aspirate.

the purpose of this study is to demonstrate the efficacy of the combined use of platelet-rich plasma (prp) with lipoaspirate and/or bone marrow aspirate in osteoarthritis of major joints, and to compare the outcomes achieved using three combinations: prp plus lipoaspirate, prp plus bone marrow aspirate, and prp plus both lipoaspirate and bone marrow aspirate. a total of 240 participants will be randomly assigned to one of three treatment groups: group a will receive prp plus lipoaspirate, group b will receive prp plus bone marrow aspirate, and group c will receive tri-partite therapy of prp + lipoaspirate + bone marrow aspirate which allows for 80 in each group. the combination of biologic materials will be injected in to an arthritic joint.

Eligibility criteria:
inclusion criteria: 1. capable of providing written informed consent and willing and able to adhere to all protocol requirements. 2. male or female at least 19 years of age at the time of providing written informed consent. 3. evidence of osteoarthritis in a major joint requires recent (within one year) imaging, either by x-ray or mri. kellgren \& lawrence grades 1-3 are accepted for participation. exclusion criteria: 1. bmi \> 35 2. arthroscopic surgery to the treatment joint within 12 months 3. cortisone or ha injection within the last 3 months prior to stem cell injection 4. inability to hold antiplatelet therapy according to treating provider prior to procedure 5. kellgren \& lawrence grade 4 osteoarthritis 6. participants with a platelet count less than 100 x 109 7. participants with a hemoglobin less than 100 g/l 8. participants who have an active infection with fever and/or elevated white blood cell (wbc) count 9. participants with an active cancer diagnosis. 10. participants with autoimmune disorders including rheumatoid arthritis and lupus. 11. women who are pregnant will be excluded due to the possibility of fetal harm associated with x-rays. should a participant become pregnant during the study, she will be withdrawn from further treatment and imaging, but can participate in symptom follow-up. female participants of childbearing potential will be counseled at screening about contraception and encouraged to use birth control for the duration of the study. 12. participants with allergies to lidocaine, heparin, or epinephrine.

Keywords: osteoarthritis platelet rich plasma (prp) micronized lipoaspirate (mat) bone marrow aspirate (bma)
s9704-s0014-s0313a studying genes in samples from patients with limited or advanced diffuse large b-cell lymphoma

Conditions: Lymphoma

Summary: rationale: studying samples of tumor tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. it may also help doctors find better ways to treat cancer. purpose: this research trial studies genes in samples from patients with limited and advanced diffuse large b-cell lymphoma.

objectives: * to determine the proportion of the cell of origin subtypes (germinal center b-cell-like \[gcb\] vs non-gcb) and expression levels of prognostic genes previously identified in diffuse large b-cell lymphoma (dlbcl) in patient biopsy samples from swog trials of limited- and advanced-stage dlbcl, and to assess the association between the results and progression-free survival (pfs). * to assess the association between these marker results and overall survival (os). outline: archived formalin-fixed paraffin-embedded tissue are analyzed for gene expression profile by quantitative nuclease protection assay (qnpa) and immunohistochemical analyses. results are then compared with each patient's progression-free survival and overall survival.

Eligibility criteria:
disease characteristics: * diffuse large b-cell lymphoma - initial diagnostic tissue block, or 4 unstained slides * tissue from patients with limited-stage dlbcl enrolled on swog trials treated with cyclophosphamide, doxorubicin hydrochloride, prednisone, and vincristine sulfate (chop), and monoclonal anti-cd20 antibody backbone * swog-s0014 * swog-s0313 * tissue from patients with advanced-stage dlbcl enrolled on swog trials treated with chop and monoclonal anti-cd20 antibody backbone * swog-s9704 * swog-s0433 * swog-s0515 * swog-s0806 patient characteristics: * not specified prior concurrent therapy: * see disease characteristics

Keywords: contiguous stage ii adult diffuse large cell lymphoma noncontiguous stage ii adult diffuse large cell lymphoma stage iii adult diffuse large cell lymphoma stage iv adult diffuse large cell lymphoma
urinary transglutaminase 2 as a biomarker for kidney allograft fibrosis

Conditions: Kidney Allograft Fibrosis; Kidney Transplant Failure and Rejection

Summary: the aim of this study is to verify the ability of transglutaminase type 2 to predict rejection or chronic allograft nephropathy of renal allograft. on the basis of biomolecular mechanisms aggravating chronic allograft nephropathy, we eventually expect to develop the remedy to prevent chronic allograft nephropathy after kidney transplantation.


Eligibility criteria:
inclusion criteria: * kidney transplant recipients from cadaveric or living donors * kidney transplant recipients who take immunosuppressants regularly * kidney transplant recipients who voluntarily agree to participate in this trial exclusion criteria: * multiorgan transplant recipients * kidney transplant recipients with active infection * kidney transplant recipients with alcohol or drug addiction

Keywords: transglutaminase type 2 kidney transplantation chronic allograft nephropathy biomarker
morphine analgesia in patients with acute appendicitis

Conditions: Appendicitis

Summary: the purpose of the study is to evaluate morphine effect on pain reduction and diagnostic accuracy in patients admitted to emergency ward with the diagnosis of acute appendicitis.

analgesic administration for pain control in patients with acute abdominal pain, regarding acute appendicitis, is controversial. despite the results previous studies indicating the safeness of analgesic use in ed for acute abdominal pain, physicians still prefer to postpone their use after performing surgical evaluations. since many patients admitted to ed are unlikely to receive prompt surgical consultation, many of them need pain relief to prevent unnecessary suffering. on the other hand such pain relief must not interfere with the diagnosis and treatment of patients and do not cause any complications. morphine is a common and effective analgesic which, if shown to have no effect on correct diagnosis of acute abdomen, can be used for this purpose. thus we evaluated morphine effect on pain reduction and diagnostic accuracy in patients admitted to ed with the diagnosis of acute appendicitis.

Eligibility criteria:
inclusion criteria: * clinical signs of acute appendicitis * planned for appendectomy * supposed to wait for at least 1 hour in the ed before operation exclusion criteria: * suspicion to perforated appendicitis * being under the age of 13 * pregnancy (according to history and ß-hcg result) * opium addiction * systolic blood pressure of less than 90 mmhg * known cases of chronic obstructive pulmonary disease (copd) * known sensitivity to morphine * history of sickle cell disease * self administration of analgesics before enrollment * refusal to participate

Keywords: morphine analgesia acute appendicits
real world study of oral upadacitinib tablets to assess adverse events and change in disease activity in adolescent and adult chinese participants with atopic dermatitis

Conditions: Atopic Dermatitis (AD)

Summary: atopic dermatitis (ad) is a skin condition that may cause a rash and itching due to inflammation of the skin. this study will assess how safe and effective upadacitinib is in treating ad in adolescent and adult chinese participants. upadacitinib is an approved drug for treating ad. approximately 200 adolescent and adult participants who are prescribed upadacitinib by their physician in accordance with local label will be enrolled in china. participants will receive upadacitinib as prescribed by their physician according to their routine clinical practice and local label. participants will be followed up for approximately 24 months per participant and 30 days after last treatment dose for safety data collection. there is expected to be no additional burden for participants in this trial. participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice


Eligibility criteria:
inclusion criteria: * diagnosis of moderate to severe atopic dermatitis (ad) at the time of enrollment. * chinese adolescents (≥12 to \<18 years of age with body weight of ≥40 kg) or adults (≥18 years of age) at the time of enrollment. * participants eligible for initiation of upadacitinib treatment for ad, including any required screening tests indicated per china label. * the decision to prescribe upadacitinib is made prior to and independently of study participation. exclusion criteria: * participants who cannot be treated with upadacitinib as per china label or by judgement of treating physician. * currently participating in any interventional research studies.

Keywords: atopic dermatitis (ad) upadacitinib rinvoq
percutaneous thermal ablation in lung tumors

Conditions: Lung Cancer

Summary: lung cancer has a high incidence globally, with egypt having it as the third most common and most lethal cancer, affecting 16.9% of males and 3.8% of females. while surgery is the preferred treatment for stage 1 non-small cell lung cancer due to positive outcomes, it carries significant risks due to patient comorbidities. non-invasive treatments like radio frequency ablation (rfa) and microwave ablation (mwa) are alternatives for those unable to undergo surgery. these techniques use energy to destroy tumor tissue with minimal invasiveness and can be guided by computed tomography to ensure accurate ablation.

the incidence of lung cancer is one of the highest in the world. in egypt lung cancer is the third common cancer and the most lethal malignancy in egypt . where it is responsible for 16.9% and 3.8% of all cancers in males and females respectively. surgery is universally accepted as the best choice of therapy in stage 1 non small lung cancer , this is based on favourable outcomes observed in patients who have been surgically treated. however surgery is often high risk procedure because of several comorbidities affecting this cohort of patients. therefore non invasive local treatment that makes it possible to avoid resection of functioning parenchyma or prolonged general anaethesia representa key point in management of patients who are not eligible for surgery. the ablative technologies utilize several sources of energy and different devices to damage targeted tissue using either radio frequency ablation (rfa) or microwave ablation (mwa) which are mini-invasive procedures as they deliver energy to tumour through single or multiple percutaneous needles. the goal of ta is to induce targeted tissue damage by heating cells to +60 celsius to obtain a complete necrosis of tumour and surrounding tissue, ta may be performed under either conscious sedation or general anaethesia to avoid pain caused by needle insertion and tissue heating. computed tomography is today only accurate image guidance method for lung ta, ct guarantees a direct post-procedure .evaluation of ablation, and ground glass opacity is an indicator of extent of ablation achieved to tumour

Eligibility criteria:
inclusion criteria: * lung cancer smaller than 5 cm * metastasis to the lung * patients with lung cancer and multiple comorbidities who are unfit for surgery exclusion criteria: * lung cancer larger than 5 cm * lung cancer stage ii or more * patients who cannot tolerate ct guided needle placement for thermal ablation of lung tumors