Kornimate/medical-research-clean huggingface dataset:
pi3kδ inhibitor parsaclisib combined with chidamide for the treatment of relapsed/refractory peripheral t-cell lymphoma

Conditions: Peripheral T-Cell Lymphoma

Summary: this is a prospective single-arm, multicenter, phase ib/ii clinical trial of pi3kδ inhibitor parsaclisib combined with chidamide for the treatment of relapsed/refractory peripheral t-cell lymphoma.


Eligibility criteria:
inclusion criteria: 1. age between 18 to 75 years old (including 18 and 75) 2. agreeing to sign the written informed consents 3. diagnosed as peripheral t-cell lymphoma, including peripheral t-cell lymphoma, unspecified type, anaplastic large cell lymphoma (alk negative or positive), angioimmunoblastic t-cell lymphoma, enteropathy related t-cell lymphoma, hepatosplenic t-cell lymphoma, γ/δ t-cell lymphoma, nk/t-cell lymphoma, and other subtypes of ptcl that the investigator judges to be suitable for participating in this study 4. received at least first-line anti-tumor therapy in the past, whether or not chidamide has been used 5. having at least one measurable lesions 6. world health organization-eastern cooperative oncology group performance status (ecog) 0-2 7. life expectancy no less than 3 months 8. enough main organ function 9. pregnancy test within 7 days must be negative for women of childbearing period, and appropriate measures should be taken for contraception for women in childbearing period during the study and six months after this study 10. agreeing to follow the trail protocol requirements exclusion criteria: 1. types other than peripheral t-cell lymphoma listed in the enrollment criteria 2. diagnosed as central nervous system lymphoma 3. received palliative treatment for other malignant tumors in the past 2 years 4. uncontrolled active infection 5. congestive heart failure, uncontrolled coronary heart disease, arrhythmia and heart infarction less than 6 months 6. the non-hematological toxicity caused by the previous anti-tumor treatment has not recovered to ≤1 grade, and the hematological toxicity has not recovered to ≤2 grade 7. patients with a history of mental illness 8. those who are known to be allergic to the active ingredients or excipients of the drug parsaclisib and chidamide 9. received pi3kδ inhibitor treatment in the past 10. received autologous hematopoietic or allogeneic hematopoietic stem cell transplantation within 3 months 11. world health organization-eastern cooperative oncology group performance status (ecog) \>2 12. there are factors that affect the absorption of oral drugs 13. pregnant or lactating women 14. researchers determine unsuited to participate in this trial

Keywords: relapsed/refractory peripheral t-cell lymphoma pi3kδ inhibitor chidamide
variability of hemoglobin levels after kidney transplantation

Conditions: Renal Anemia

Summary: the purpose of this study es to determine hemoglobin variability in kidney transplant recipients with chronic renal anemia.

the primary endpoint of the study is hemoglobin level variability. for determination of this variability, the following patterns of hemoglobin level change will be established: * target range hemoglobin (trh): patients with hemoglobin values in the range of 11.0-12.0g/dl throughout the study period. * low hemoglobin (lh): patients with levels below 11.0g/dl * high hemoglobin (hh): patients with levels above 12.0g/dl * low-amplitude fluctuation with low hemoglobin (lalh): patients with at least one measurement of hemoglobin levels \ 12.0g/dl. * low-amplitude fluctuation with high hemoglobin (lahh): patients with at least one measurement of hemoglobin levels \>12.0g/dl and at least one measurement in the range of 11.0-12.0g/dl, but without hemoglobin measurements \<11.0g/dl. * high-amplitude fluctuation (hah): patients with at least one measurement of hemoglobin levels \ 12.0g/dl. secondary objectives: * to determine potential factors influencing hemoglobin variability. * to assess the influence of hemoglobin variability on cardiovascular risk of patients according to the regicor function at the end of the study period.

Eligibility criteria:
inclusion criteria: * patients aged \> or = 18 years. * kidney transplant recipients with chronic renal failure stage 3 (glomerular filtration rate: 30-59ml/min/1.73m2), 4 (glomerular filtration rate: 15-29ml/min/1.73m2) or 5 (glomerular filtration rate: \<15ml/min/1.73m2) at the start of the study follow-up period. * diagnosis of anemia and drug treatment initiated or changed subsequent to june 29, 2010 (date on which the latest recommendation by european renal best practice on the target range for hemoglobin levels were published) * patients capable of giving their informed consent to participate in the study and who agree to participate by signing the informed consent form. exclusion criteria: * patients whose medical history lacks measurements of hemoglobin levels every three months (±1 month) during the year of study follow-up.

Keywords: chronic renal anemia hemoglobin kidney transplant
a study of zn-c3 in women with recurrent or persistent uterine serous carcinoma

Conditions: Uterine Serous Carcinoma

Summary: this is a phase 2 study to evaluate the clinical activity and safety of zn-c3 (azenosertib) in adult women with recurrent or persistent uterine serous carcinoma (usc).

this is a phase 2 open-label, multicenter study to evaluate the clinical activity and safety of zn-c3 (also known as azenosertib; kp-2638) in adult women with recurrent or persistent uterine serous carcinoma (usc).

Eligibility criteria:
inclusion criteria 1. females ≥18 years of age at the time of informed consent. 2. histologically confirmed recurrent or persistent usc for which no other proven effective treatment options are available or any available standard of care therapy was not tolerated or was refused by the subject. * subjects with endometrial carcinoma of mixed histology where the serous component comprises at least 5% of the tumor will be considered eligible. * subjects with carcinosarcomas (even if there is a serous component) are not eligible. 3. measurable disease per recist guideline version 1.1 4. required prior therapy for endometrial cancer: 1. treatment with a platinum-based chemotherapy regimen. 2. treatment with a pd-(l)1 inhibitor 3. known her2-positive tumors: treatment with at least 1 her2-targeted therapy, except for subjects who are not clinically eligible. 5. adequate hematologic and organ function exclusion criteria 1. any of the following treatment interventions within the specified time frame prior to c1d1: 1. major surgery within 28 days 2. any chemotherapy or targeted tumor therapy within 14 days or 5 half-lives (whichever is shorter). 3. radiation therapy within 21 days; 4. autologous or allogeneic stem cell transplant within 3 months. 5. current use of any other investigational drug therapy \<28 days or 5 half-lives (whichever is shorter). 2. prior therapy with zn-c3 or any other wee1 inhibitor, atr inhibitor, or chk1/2 inhibitor for usc. 3. a serious illness or medical condition(s) including, but not limited to: any evidence of bowel obstruction as determined by air/fluid levels on computed tomography (ct) scan, recent hospitalization for bowel obstruction within 3 months prior to c1d1, or recurrent paracentesis or thoracentesis within 6 weeks prior to c1d1.

Keywords: uterus uterine endometrial endometrium serous carcinoma wee1 wee-1 usc uterine serous carcinoma serous
covid-19 rapid diagnostic tests on blood drop

Conditions: Covid19

Summary: this study will evaluate the diagnostic reliability of the biosynex rapid blood test for covid-19 infection.

the covid-19 pandemic requires a reliable diagnosis of affected patients in order to manage them in an appropriate manner, in the appropriate departments. furthermore, the diagnostic reference at the time of this study is based on reverse transcription by reaction in polymerase chain reaction (rt-pcr) on a nasopharyngeal swab taken. this method has may yield false negatives (up to 30% depending on the series) and its lead time is several hours. alternatives are therefore being developed, in particular rapid blood tests. the rapid diagnostic test distributed by biosynex has been evaluated by the national reference center for respiratory infections viruses as very specific for the detection of igg + igm (93%). as part of the evaluation of this test, it was used in patients with severe covid-19 disease, requiring hospitalization in critical care in order to be able to establish their reliability in a clinical context where many confounding factors may occur, such as lymphopenia or systemic inflammation. however, the early diagnosis of this patient population remains critical in order to be able to refer them to the appropriate services.

Eligibility criteria:
inclusion criteria: * confirmed covid-19 diagnosis with at least one positive rt-pcr exclusion criteria: * none

Keywords: covid 19 diagnostic biosynex blood drop
best treatment modality of frozen shoulder

Conditions: Shoulder Adhesive Capsulitis

Summary: this study will compare between the effect of three treatment modalities of shoulder adhesive capsulitis to hilight the best technique to improve pain and range of motion outcome measures .


Eligibility criteria:
inclusion criteria: * gross limitation of passive shoulder movement * pain interfering with daily activities * painful restiction of active and passive movement of shoulder exclusion criteria: * presence of degenerative pathology * fracture * contraindication to steroid injection * deformity affecting upper limb * history of previous shoulder injection in the past 4 weeks
effects of restylane-l® filler injection for non-surgical rhinoplasty

Conditions: Deformity of Nasal Cartilage

Summary: the purpose of this research is to determine the effects of restylane-l® filler injection for non-surgical rhinoplasty on first impressions and quality of life determined by using the face-q scale. secondary objectives include: to determine the efficacy of restylane-l® filler injection to the nose in reduction of convexity of the nasal dorsum as measured on pre/post injection 2d photographs. to measure changes in nasal projection and rotation after injection with restylane-l® filler in subset of patients who underwent nasal tip augmentation. to determine the safety of restylane-l® filler injection to the nose for non-surgical rhinoplasty.


Eligibility criteria:
inclusion criteria: 1. males and females of ages 21 and above. 2. subjects will be required not to have had previous filler injections, or other cosmetic treatments to the nose within the last 12 months. 3. subjects that understand the purpose and aspects of the study, freely sign the consent and complete the required treatment and follow up visit. exclusion criteria: 1. males and females below age of 21. 2. subjects who have had previous filler injections, or other cosmetic treatments to the nose within the last 12 months. 3. subjects who are pregnant or nursing. 4. subjects with a known allergy or sensitivity to any component of the study ingredients. 5. any history of bleeding disorders (iatrogenic or otherwise). this includes persons who have undergone therapy with thrombolytics, anticoagulants, or inhibitors of platelet aggregation in the preceding 3 weeks. 6. anyone taking aspirin, ibuprofen, st. john's wort, or high doses of vitamin e supplements in the last 3 weeks. 7. subjects with diseases, injuries, or disabilities of the nose, including those with autoimmune disease affecting the nose, implants, and previous surgical rhinoplasty. 8. subjects that do not understand the purpose and aspects of the study, do not sign the consent and do not complete the required treatment and follow up visit will also be excluded.
effectiveness of pain neuroscience education compared to a conventional education for patients with chronic low back pain

Conditions: Chronic Low-back Pain

Summary: the hypothesis is that pain biology education, combined with a rehabilitation program, reduces disability to 3 months, compared to conventional spinal physiology education.


Eligibility criteria:
inclusion criteria: * low back pain since more than 1 year * affiliated to social security scheme * rolland moris ≥ 8 * start back ≥ 4 exclusion criteria: * suspicion or proven case of serious pathology such as recent vertebral fracture (less than 6 months), infection, malignant tumors and / or radiculopathy. * have a history of rheumatic inflammatory disease * have a true radiculalgia (with or without radiculopathy) * have a scoliosis \> 30° (if it is considered as a predominant contributor of pain's persistence). * rating of pain \> 8/10 * have had lumbar surgery in the past 12 months * have had an injection in the past 3 months * patients under legal protection (guardianship, curatorship) * pregnant patients * patients who are not able to understand, read or speak french * inability to receive informed information

Keywords: therapeutic patient education chronic low back pain chronic pain pain neuroscience education pain neurophysiology education pain biology education
national survey on care pathway and quality of life in patients with severe asthma according to their phenotype.

Conditions: Asthma Chronic; Severe Asthma

Summary: the second souffle survey focuses on aspects of care and quality of life in a period when the landscape of severe asthma is changing in the context of biotherapies. moreover survey on care pathway and quality of life of the asthmatic severe population according to their phenotype have never been done. it is likely to bring results in a relatively fast time, results that can lead to guide the criteria collected in ramses a national severe asthma cohort and future research tracks of this cohort.

the th2 phenotype corresponds to severe asthmatic patients eligible for new subcutaneous targeted asthma therapies, which can bring about a real improvement in symptoms and quality of life. no data are available on the proportion of this patient population since the advent of biotherapies, as well as the impact on quality of life and pathway by phenotype. the survey will be conducted using a collection of data on a dedicated questionnaire including validated questionnaires on the quality of life and the control of the asthmatic disease as well as the therapeutic observance. the objectives of the survey are to estimate the phenotypic profile distribution of severe asthmatic patients and the proportion currently treated by biotherapies as well as the impact of the pathology on the clinical profile and quality of life of patients with severe asthma. investigative pulmonologists selected from university or general hospitals or from private practice will propose to their eligible patients to participate in the study. patients informed and not opposed to participating will complete, at the end of the consultation, the dedicated questionnaire pre-filled by the pulmonologist (for the medical data required for phenotypic stratification). the questionnaires will be collected from the centers and the data centralized to establish the database. analyzes will be done in order to stratify the populations according to their phenotype and to analyze the data globally and by subgroup.

Eligibility criteria:
inclusion criteria: * diagnosis of severe asthma for at least 12 months confirmed by a respiratory physicians and meeting the ats / ers definition, * social insured patient, * patient given the non-opposition exclusion criteria: * patient participating in a therapeutic clinical trial * patient opposing participation in this study * patient with reading and comprehension difficulties not allowing him to complete the questionnaires

Keywords: severe asthma th2 phenotype care pathway quality of life
efficacy and safety of resveratrol and carbossimetyl beta glucan in treatment of upper airways disease in infancy

Conditions: Common Cold

Summary: outpatient infants (0-6 months of life), affected by symptoms of upper airways disease will be randomly assigned to two type of intervention: a: treatment group, receiving resveratrol and carbossimetyl beta glucan; b: control group, receiving saline solution. each subject underwent clinical history, objective examination and detection of rinovirus in the nasal secretions at enrollment, after 48 hours and after 7 and 30 days.

consecutive outpatient infants (0 - 6 months) with common cold symptoms were enrolled and randomly divided into two groups: resveratrol plus carboxymethyl-β-glucan solution or saline isotonic solution randomized treatment (3 drops in each nasal fossa, 4 time daily for seven days). each patient underwent clinical evaluation at enrollment, after 48 hours and after 7 and 30 days. common cold symptoms were specifically evaluated according to carifs scale. nasal swabs for hrv research will performed at enrollment, after 48 hours and after 7 and 30 days.

Eligibility criteria:
inclusion criteria: * common cold syndrome exclusion criteria: * main comorbidities
safety, pharmacokinetics and pharmacodynamics of recombinant chimeric anti-cd20 monoclonal antibody in patients with b-cell non-hodgkin's lymphoma.

Conditions: B-cell Non Hodgkin's Lymphoma

Summary: the purpose of this study is to determine whether sct400 is safe and effective in the treatment of b-cell non hodgkin's lymphoma


Eligibility criteria:
inclusion criteria: * aged from 18 to 75 years * having histologically confirmed nhl expressing cd20 antigen * having relapsed non-hodgkin's lymphoma(nhl) after at least one prior course of standard therapy * eastern cooperative oncology group (ecog) performance status ≤ 2 according to who scale, and expected survival of at least ≥ 3 months * signed an informed consent form which was approved by the institutional review board of the respective medical center exclusion criteria: * single measurable lesion ≥7 cm in diameter * with serious hematologic dysfunction (white blood cell count of \ 1.5×upper limit of normal（uln）; aspartate amino transferase (ast) and alanine amino transferase (alt) levels of \>2.5 × uln (≥5 × uln for patients with liver metastases)); and renal dysfunction (serum creatinine level of \> 1.5×uln ) * having to be at least 4 weeks beyond prior anticancer therapy including corticosteroid, or participating in other clinical trial or have not recovered from significant toxicities of prior therapy * had received rituximab or other anti-cd20(+) monoclonal antibody treatment within 1 year before enrollment * had received hematopoietic cytokines, e.g csf、epo within 1 week prior to study entry * with other malignancies ; or central nervous system (cns) lymphoma, aids- related lymphoma; or active opportunistic infection, a serious nonmalignant disease * having hepatitis b virus surface antigen and /or antibodies to hepatitis c virus or human immunodeficiency virus * with pleural effusions or ascites secondary to lymphoma; or high risk of tumor lysis syndrome; or recent major surgery (within 28 days ) * with a history of allergic reaction or protein product allergy including murine proteins * pregnant or lactating or not accepted birth control methods including male patients

Keywords: chimeric anti-cd20 monoclonal antibody(sct400) escalating doses safety pharmacokinetics and pharmacodynamics
effectiveness of asiaticoside as intracanal medication on infectious/inflammatory contents in teeth with apical periodontitis

Conditions: Intracanal Medication

Summary: the objective of this study is to investigate \&#34;clinically\&#34; the effectiveness of asiaticoside based intracanal medication compared to the commonly used intracanal medicaments (calcium hydroxide ca(oh)2 and ledermix) on the levels of bacteria and inflammatory cytokines in root canals and periradicular tissues of teeth with apical periodontitis.

this study investigate \&#34;clinically\&#34; the effectiveness of asiaticoside based intracanal medication compared to the commonly used intracanal medicaments (calcium hydroxide ca(oh)2 and ledermix) on the levels of bacteria and inflammatory cytokines in root canals and periradicular tissues of teeth with apical periodontitis.

Eligibility criteria:
inclusion criteria: • single-rooted with pulp necrosis and apical periodontitis. exclusion criteria: receiving antibiotic treatment within the preceding 3 months. * reporting systemic disease. * teeth that could not be isolated with rubber dam. * teeth with periodontal pockets deeper than 3 mm.

Keywords: inflammation asiaticoside pulpal necrosis
observational study for the evaluation of incidence of systemic mastocytosis in t(8;21) acute myeloid leukemia

Conditions: Systemic Mastocytosis With AHNMD; Acute Myeloid Leukemia With T(8;21)(Q22;Q22)

Summary: the observational study aimed at evaluating the incidence of systemic mastocytosis associated with t(8;21) aml in patients with de novo t(8;21) aml and their responses to first induction, and the prognosis from standard therapy.

this is a multicenter, retrospective and prospective, observational study that aims to collect clinical information on patients with systemic mastocytosis associated with t(8;21) aml from september 2022 to august 2023. no intervention is expected. the purpose of this study is to identify and characterize the patients with systemic mastocytosis associated with t(8;21) aml, t(8;21) aml without systemic mastocytosis, and osm (oligo-mastocytic sm) with associated t(8;21) aml. in order to estimate the incidence of systemic mastocytosis associated with t(8;21) aml, a survey will be sent every month to all participating sites to collect the number of all diagnoses of systemic mastocytosis associated with t(8;21) aml, t(8;21) aml without systemic mastocytosis, and osm with associated t(8;21) aml. all patients will be followed until august 2025 in order to have at least 2 years of observation.

Eligibility criteria:
inclusion criteria: 1. male or female, age (years) \>= 5; 2. newly diagnosed as t(8;21) aml patients according to world health organization (who) classification; 3. patients who sign the informed consent must have the ability to understand and be willing to participate in the study and sign the informed consent. exclusion criteria: 1. the t(8;21) aml patients with sm have been diagnosed already; 2. patients with drug abuse or long-term alcoholism that affected the evaluation of trial results; 3. patients were deemed unsuitable for enrolment by the investigator.