Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of soybean germ extract on decrease of body fat

Conditions: Obesity

Summary: this study was conducted to investigate the effects of daily supplementation of soybean germ extract on decrease of body fat

this study was a 12 weeks, randomized, double-blind, placebo-controlled human trial. 80 subjects were randomly divided into soybean germ extract 1,600 mg or placebo group. the investigators measured body fat mass, percent body fat, fat free mass, weight, and body mass index, etc.

Eligibility criteria:
inclusion criteria: * age between 19 and 65 years * bmi 25\~29.9 kg/m\^2 * after fully hearing and fully understanding this clinical trials, those who agree to voluntarily decide to participate and to comply with the notice exclusion criteria: * those who lost more than 10% of their weight within 3 months before the screening * those who take a product(body fat improvement health functional foods, birth control pills, steroids, female hormone) that affects your weight within 4 weeks prior to the screening * those with clinically significant severe cardiovascular, endocrine, immune, respiratory, liver, biliary, renal and urinary tract, neuropsychiatry, musculoskeletal, inflammatory and hematologic and gastrointestinal disorders * diabetic patients taking oral hypoglycemic agents or insulin (based on screening subjects) * a person with a history of clinically significant hypersensitivity to soybeans * those who have received antipsychotic medication within 2 months before screening * anyone with substance abuse or suspicion * those who participated in other clinical trials within 3 months before screening * systolic blood pressure(sbp) 180 mmhg, diastolic blood pressure(dbp) 110 mmhg or more * menopausal woman * laboratory test by show the following results * aspartate transaminase(ast), alanine transaminase(alt) \> reference range 3 times upper limit * serum creatinine \> 2.0 mg/dl * pregnancy or breast feeding * those who doesn't accept the implementation of appropriate contraception of a childbearing woman * principal investigator judged inappropriate for participation in study because of laboratory test result, etc.
real world outcomes using novel agents for aml in the uk

Conditions: Acute Myeloid Leukemia

Summary: this project will collect data on patients with acute myeloid leukemia in the united kingdom who were treated with two new targeted therapies during the coronavirus pandemic

acute myeloid leukaemia (aml) is a blood cancer which in fit young adults is typically treated with intensive chemotherapy. while this is potentially curative, it is associated with significant side effects and the requirement for long hospital admissions. infection is a major issue during aml treatment, as both the disease and the chemotherapy impair the immune system. early data suggested that covid-19 is associated with a very high rate of death in aml patients undergoing intensive chemotherapy. because of this, and the need for significant hospital resources to deliver intensive chemotherapy, the nhs made available two new, less intensive, targeted therapies for the treatment of aml during the covid-19 pandemic - venetoclax and gilteritinib. the aim was to reduce mortality and healthcare resource use. many hundreds of patients across the uk have been treated with these two medications on the temporary access scheme. the research aims to collect de-identified data from treating patients to describe the outcomes of patients treated with these approaches, both in terms of the safety and effectiveness.

Eligibility criteria:
venetoclax cohort inclusion criteria 1. newly diagnosed acute myeloid leukaemia 2. no prior therapies for aml, apart from hydroxyurea (or similar) for cytoreduction. previous treatments for mds or other conditions are allowed 3. treated with venetoclax in combination with either azacitidine or ldac no exclusion criteria gilteritinib/flt3 cohort inclusion criteria 1. relapsed acute myeloid leukaemia, including molecular relapse 2. treated with flt3 inhibitor no exclusion criteria
a study on the effect of 2 pen devices on hba1c

Conditions: Diabetes Mellitus, Type 1

Summary: the purpose of this study is to test the hypothesis that the humapen memoir with memory function, when used over 24 weeks for prandial insulin injections achieves superior glycemic control, when compared to the conventional humapen luxura without memory function.


Eligibility criteria:
inclusion criteria: * type 1 diabetes mellitus * receiving at least 3 prandial injections per day with short-acting or analogue insulin exclusion criteria: * insulin pump therapy * receiving pre-mixed insulin preparations
clinical trial of the tqb2928 injection in patients with advanced cancers

Conditions: Advanced Cancer

Summary: tqb2928 is a promising new molecular entity that mediates blockade of cd47 and sirpα (signal regulatory protein alpha) and enhances the phagocytosis of cancer cells by macrophages. this is a study to evaluate the safety, tolerability and effectiveness of tqb2928 injection in subjects with advanced malignancies.


Eligibility criteria:
inclusion criteria: * 1 male or female patient ≥18 years of age, an eastern cooperative oncology group (ecog) performance status of 0 to 1, and life expectancy ≥12 weeks; * 2 must have adequate organ and bone marrow function; * 3 pregnancy test (for females of childbearing potential) negative within 7 days before first dose. male and female patients of childbearing potential and at risk for pregnancy must agree to use highly effective method(s) of contraception throughout the study and for at least 6 months after the last dose of assigned treatment; * 4 evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study; * 5 histologically or cytologically confirmed, locally advanced unresectable or metastatic solid tumors, or hematological malignancies, or lymphoma; * 6 solid tumors or hematological malignancies that failed from standard therapy, or lymphoma patients who have had at least two regimens of systemic therapy failures, or who refused other systemic therapy; exclusion criteria: * 1 patients with known symptomatic brain metastases * 2 concurrent secondary malignancy. or other malignancy with no evidence of disease for more than 3 years * 3 uncontrolled pleural effusion or pericardial effusion with clinical significance and require repeated drainage as assessed by the investigators * 4 prior treatment with monospecific or bispecific antibodies or fusion proteins targeting cd47 or signal regulatory protein alpha (sirpα) * 5 therapeutic or experimental antibodies within 3 months prior to first dose * 6 approved tyrosine kinase inhibitor (tki) therapy within less than 5 half-lives prior to enrollment. * 7 major surgical procedure, radiotherapy, chemotherapy, or immunotherapy within 3 months prior to first dose; * 8 liver abnormalities including hepatitis b (hbv) and hepatitis c (hcv). * 9 history of hemolytic anemia or evans syndrome within 3 months. * 10 unstable or serious concurrent medical conditions, as assessed by the investigators, that would substantially increase the risk-benefit ratio of participating in the study.
efficacy of massage applied by the parents in hospitalized premature birth (premas)

Conditions: Massage; Premature Infant; Premature Birth; Preterm Infant

Summary: the purpose of this study was to analyze the efficacy of massage therapy and kinesiotherapy, applied by the parents of hospitalized preterm infants, in the improvement of the biological state, neuromotor activity and other associated factors.

premature infants are prematurely deprived of the cutaneous stimulation provided during intrauterine development and of the continuous contact with their parents. it has and adverse effect on both psychological and biological development of the child. knowledge of these factors has led many neonatal units to begin to introduce therapeutic massage protocols to facilitating satisfactory neuromotor and anthropometric development of preterm infants. in this study, premature newborns were assigned to one of two groups: a: control group. b: massage and kinesiotherapy group, 15 minutes twice a day.

Eligibility criteria:
inclusion criteria: * gestational age between 26 to 37 gestational weeks. * low birth weight, less than 2249 grams. * weight of at least 1250 grams at time of entry into study. * must be at least 48 hours of age. * must have hemodynamic stability. * absence of congenital and genetic anomalies. * absence of alterations of the central nervous system. * intact skin. * stable parameters (according to the neonatologist´s criteria) to participate in the intervention. exclusion criteria: * family refusal to participate in the study. * high frequency mechanical ventilation. * fraction of inspired oxygen (fio2)\>70%. * inotropic support. * septic shock. * persistent tachycardia. * persistent bradycardia. * gastrointestinal disorders.

Keywords: premature infant massage tactile kinesthetic stimulation
combination chemotherapy followed by bone marrow or peripheral stem cell transplantation in treating patients with multiple myeloma

Conditions: Multiple Myeloma and Plasma Cell Neoplasm

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. combining chemotherapy with bone marrow or peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. purpose: phase ii trial to study the effectiveness of combination chemotherapy followed by bone marrow or peripheral stem cell transplantation in treating patients with multiple myeloma.

objectives: i. assess the toxicity and efficacy at the maximum tolerated dose of busulfan, melphalan, and thiotepa in patients with multiple myeloma. outline: this is a single arm, open label study. peripheral blood stem cells (pbsc) are collected and cryopreserved, or bone marrow is harvested and stored, until infusion on day 0. patients receive oral busulfan every 6 hours on days -8, -7, and -6. melphalan is administered by continuous iv infusion over 30 minutes on days -5 and -4. thiotepa is administered by continuous iv infusion over 2 hours on days -3 and -2. patients undergo pbsc or bone marrow infusion 36-48 hours following the completion of chemotherapy (day 0). patients are followed for 100 days posttransplant and every 3 months thereafter. projected accrual: 30 patients will be accrued.

Eligibility criteria:
disease characteristics: histologically diagnosed stage ii/iii multiple myeloma (or have greater than normal beta-2-microglobulin) meeting the salmon and durie criteria stage i multiple myeloma must have had prior chemotherapy before undergoing transplantation patient characteristics: age: 70 and under performance status: karnofsky 70-100% life expectancy: not specified hematopoietic: not specified hepatic: bilirubin no greater than 2 mg/dl renal: creatinine clearance at least 50 mg/min cardiovascular: left ventricular ejection fraction at least 41% other: not pregnant hiv negative prior concurrent therapy: not specified

Keywords: stage i multiple myeloma stage ii multiple myeloma stage iii multiple myeloma
tvmr with the innovalve system trial - pilot study in italy

Conditions: Mitral Valve Regurgitation (Degenerative or Functional)

Summary: study to evaluate the safety and performance of the innovalve mitral valve replacement system


Eligibility criteria:
inclusion criteria: * clinically significant, symptomatic mitral regurgitation * high risk for open-heart surgery * meets anatomical criteria exclusion criteria: * unsuitable anatomy * patient is inoperable * ef \<30%
smartphone-based remote symptom monitoring to improve postoperative rehabilitation exercise adherence after video-assisted thoracic surgery (vats) for lung cancer

Conditions: Lung Neoplasms, Non-Small Cell Lung Cancer; Postoperative Complications; Patient Reported Outcome Measures; Telerehabilitation; Exercise Therapy

Summary: brief summary: this randomized controlled trial aims to evaluate whether active remote symptom monitoring and management via a smartphone app utilizing electronic patient-reported outcomes (epro) can improve adherence to prescribed outpatient pulmonary rehabilitation exercises among postsurgical lung cancer patients. eligible patients will use the app for perioperative care and be randomized to an intervention group receiving epro-based symptom monitoring with clinician feedback or a control group receiving epro without feedback. the primary outcome is rehabilitation exercise adherence rate over 1 month after discharge. if proven effective, the app-enabled remote rehabilitation model can be scaled up to enhance recovery for more postoperative patients.

adherence to postoperative pulmonary rehabilitation exercises is crucial but challenging to address in lung cancer patients after hospital discharge. pain, fatigue, cough and other symptoms may hinder adherence. this study will enroll 224 patients undergoing video-assisted thoracic surgery (vats) for lung cancer. all patients will use a smartphone app for perioperative care and periodic pro measurement. before discharge, patients will be randomized 1:1 to an intervention group or control group. the intervention group will complete epro symptom severity scores on the psa-lung scale questionnaire on discharge and post-discharge days 3, 7, 14, 21, 28. alerts are triggered if any of 5 core symptoms scored ≥4, prompting remote clinician feedback and guidance. the control group will complete epro without clinician alerts. the primary outcome is rehabilitation exercise adherence rate over 1 month after discharge. secondary outcomes include postoperative complications, hospital readmissions, symptom changes, exercise participation rate, and patient satisfaction. if proven effective, this innovative rehabilitation model can be scaled up to enhance recovery for more postoperative patients.

Eligibility criteria:
inclusion criteria: * age 18-75 years old * undergoing minimally invasive lung cancer resection * able to use smartphones and complete electronic questionnaires * signed informed consent exclusion criteria: * conversions to open thoracotomy during surgery * ecog score \> 1 * received neoadjuvant therapy * previous lung resection surgery * unable to exercise due to physical limitations * continuous systemic corticosteroid use within 1 month before enrollment * unresolved toxicity above grade 1 from previous treatments * significant comorbidities or medical history

Keywords: exercise adherence epro remote monitoring postoperative rehabilitation symptom management
evaluation of the effect of systemic proteolytic enzyme therapy on postoperative inflammatory response and qol after surgical extraction of impacted mandibular third molars

Conditions: Post Operative Pain

Summary: 1. to compare the postoperative pain between the patients who receive the systemic enzyme therapy and patients in the control group in the third and seventh day. 2. to compare the postoperative swelling (edema) between the patients who receive the systemic enzyme therapy and patients in the control group in the third and seventh day. 3. to compare the degree of trismus between the patients who receive the systemic enzyme therapy and patients in the control group in the third and seventh day. 4. measure patients' perceptions of changes in their quality of life in the postoperative period and compare it between the patients who receive the systemic enzyme therapy and patients in the control group in the third and seventh day.

evaluation of the effect of systemic proteolytic enzyme therapy on postoperative inflammatory response and quality of life after surgical extraction of impacted mandibular third molar. the aim of this study is to evaluate the effect of systemic enzyme therapy(tibrolintm) on the postoperative inflammatory response and the quality of life after surgical removal of impacted third molar. the study is designed and was implemented as a randomized controlled clinical study guided by consolidated standards of reporting trials (consort) guidelines . patients were randomly allocated to two groups (25patients per group). group a included administration of set after surgery and continued for 5 days post-surgery; group b, a control group that would not receive the systemic enzyme therapy . the predictor variable was the use of systemic proteolytic enzyme (tibrolin) or not .the primary outcome variables were pain and swelling , trismus,quality of life measured on 1st day (day of surgery), third day, and 7th after surgery.

Eligibility criteria:
inclusion criteria: * healthy patients over 18 years old of either gender. * patients who have impacted mandibular third molar. * ability to tolerate surgical procedure. * pell and gregory's classification (class i and class ii, position a and b). exclusion criteria: * patients with uncontrolled systemic diseases. * patients with history of chemotherapy or radiotherapy therapy to the head and neck region. * acute infection at the surgical site at time of operation. * the presence of cysts or tumors associated with the impacted teeth. * pell and gregory's classification (class iii position c)

Keywords: systemic proteolytic enzyme pain trismus swelling tibrolin
subtyping of insomnia disorders based on multidimensional features

Conditions: Insomnia Disorder

Summary: based on real world and focusing on patients with chronic sleep disorders, this study conducts a data-driven subtyping research on the clinical symptoms, polysomnography, near-infrared scanning, molecular genetics, and other characteristics of chronic insomnia disorders. it constructs a multimodal therapeutic outcome prediction model, providing a basis for personalized interventions for chronic insomnia disorder.


Eligibility criteria:
inclusion criteria: 1. aged between 18 and 65 years, regardless of gender; 2. currently meeting the diagnostic criteria for insomnia disorder according to the fifth edition of the diagnostic and statistical manual of mental disorders (dsm-5); 3. pittsburgh sleep quality index (psqi) total score ≥ 10; 4. sufficient level of education and comprehension to complete the required examinations and assessments for this study; 5. voluntarily participating in this research and signing the informed consent form. exclusion criteria: 1. currently diagnosed with other sleep disorders (sleep-related breathing disorders, periodic limb movement disorder, parasomnias, central disorders of hypersomnolence, circadian rhythm sleep-wake disorders, etc.); 2. currently diagnosed with organic brain diseases (epilepsy, cerebrovascular disease, etc.) or other organic diseases; 3. patients with a history of or currently diagnosed with bipolar and related disorders, obsessive-compulsive and related disorders, schizophrenia spectrum and other psychotic disorders, trauma and stressor-related disorders, dissociative disorders, or eating disorders; 4. women who are pregnant, breastfeeding, or planning to become pregnant during the study period; 5. insomnia caused by alcohol or substance abuse; 6. high suicide risk, with hamd-17 suicide factor score \> 2; 7. inability to cooperate with near-infrared examinations and polysomnography due to physical conditions such as head injury, etc.
in search of the correct diagnosis of beta-lactam allergy: from the validation of a risk stratification tool to accurate endotyping

Conditions: Drug Allergy

Summary: testing a clinical decision tool (bl-predictor)


Eligibility criteria:
inclusion criteria: * signed informed consnet exclusion criteria: * use of immunomodulators, antihistamines and corticosteroids
effectiveness of chronic kidney disease nurse-led self-management program (ckd-nlsm)

Conditions: Renal Insufficiency

Summary: this study aims to develop, implement and evaluate the effectiveness of a theory-driven nurse-led self-management intervention program compared to standard usual care in people with ckd stages 3-4 on ckd knowledge, self-management behavior, self-efficacy and hrqol using valid and reliable instruments in malaysia.

patients aged ≥ 18 years with ckd stages 3-4 will be recruited between july 2019 - october 2019. participants will be randomly allocated into either the intervention (n = 77) or control group (n = 77). the control group will receive standard usual care, while the intervention group will receive standard usual care plus a self-management program delivered by renal nurse educators. the intervention will be guided by social cognitive theory and include group-based educational sessions, ckd booklet and follow-up phone calls. both groups will be followed for 12 weeks. data will be analyzed using spss version 25. the primary outcomes are improving in knowledge and self-management, while the secondary outcomes are improving in self-confidence, quality of life and clinical outcomes of the participants.

Eligibility criteria:
inclusion criteria: * the inclusion criteria are ckd (stages 3-4), aged ≥ 18 years, could speak, read, and understand malay language, able to give informed consent, had never participated in any structured education program before, willing to participate in the study and most importantly not expected to start dialysis during the study. exclusion criteria: * participants will be excluded if they had esrd, were receiving dialysis or were cognitively impaired.

Keywords: chronic kidney disease health related quality of life knowledge randomized controlled trial self-management self-efficacy social cognitive theory
comparison of two types of biopsy in suspicious axillary lymph nodes

Conditions: Breast Neoplasms

Summary: axillary lymph node status is a vital prognostic factor in breast cancer patients and provides crucial information for making treatment decisions. ultrasound test with subsequent fine needle aspiration (fna) biopsy in nodes with suspicious features remains the standard of axillary lymph node workup. insufficient sampling and limited diagnostic accuracy of cytological test compromise the outcome the preoperative lymph node staging strategy especially in patients with intermediate suspicious nodes. this prospective study is to compare the performance of a crpo-assisted core biopsy with fna.

this prospective study was planned to evaluate the superiority of a core needle biopsy device with a special cryo-assisted rotational design (cassi ii, usa) compared with fna for biopsy of intermediately suspicious lymph nodes. eligible patients would be randomized to one of two arms by 1:2 : core with fna or fna alone. the diagnostic accuracy and adverse outcome of core and fna would be compared.

Eligibility criteria:
inclusion criteria: * histologically confirmed invasive breast cancer. * with axillary lymph node with thickened cortex. * planned for sentinel lymph node biopsy or axillary clearance. exclusion criteria: * nodes ultrasonographically normal. * nodes with hilar displacement . * palpable matted nodes.

Keywords: breast neoplasms ultrasonography, interventional biopsy, large-core needle biopsy, fine-needle
diarrhea and stipsis in critically ill patients (nutriti)

Conditions: Critical Illness; Nutritional and Metabolic Disease; Nutritional Deficiency; ICU Acquired Weakness; Enteral Feeding Intolerance; Diarrhea; Constipation

Summary: this study prospectively observed the complications intended as diarrhea or sti-sis that critically ill patients developed within 7 days after icu admission. in addition, secondary aims investigated through bioimpedenziometry the loss of lean body mass and changes in phase angle during the same period of icu stay.


Eligibility criteria:
inclusion criteria: * icu anticipated length of stay \> 72 hours * age \> 18 years * need for artificial nutrition exclusion criteria: * age \< 18 years * icu anticipated length of stay \< 72 hours * no need for artificial nutrition * bmi\<16 kg/m2