Kornimate/medical-research-clean huggingface dataset:
a study of duvelisib versus gemcitabine or bendamustine in participants with relapsed/refractory nodal t cell lymphoma with t follicular helper (tfh) phenotype

Conditions: Lymphoma

Summary: the study will evaluate the progression-free survival benefit of duvelisib monotherapy as compared to investigator's choice of gemcitabine or bendamustine in participants with relapsed/refractory nodal t cell lymphoma with tfh phenotype.


Eligibility criteria:
key inclusion criteria: * pathologically confirmed nodal t cell lymphoma with tfh phenotype according to the criteria of the world health organization classification (swerdlow 2017, alaggio 2022) including any one of angioimmunoblastic t cell lymphoma (aitl), follicular t cell lymphoma, and other nodal peripheral t cell lymphoma (ptcl) with a tfh phenotype. * relapsed or refractory to at least 1 prior systemic, cytotoxic therapy for t cell lymphoma. * measurable disease as defined by lugano 2014 criteria (cheson 2014) for t cell lymphoma. key exclusion criteria: * cutaneous-only disease. * received prior allogeneic transplant any time in the past or received autologous transplant within 60 days prior to the first dose of study drug. * received prior treatment with a phosphoinositide-3-kinase (pi3k) inhibitor. * prior exposure to planned study treatment investigator's choice therapy (gemcitabine or bendamustine) within 60 days prior to the first dose of study drug. other protocol-defined criteria apply.

Keywords: nodal t cell lymphoma t follicular helper relapsed/refractory duvelisib peripheral t cell lymphoma angioimmunoblastic t cell lymphoma terzo 145-304
zometa® (zoledronic acid) for prevention of bone metastases

Conditions: Prostate Cancer

Summary: to determine if therapy with zometa® (zoledronic acid) 4mg will be effective in preventing the occurrence of bone metastases in prostate cancer patients at high risk of developing them. in addition, pain and analgesic scores and overall safety are to be evaluated throughout the study.

this is a prospective, randomized, stratified open-label (zometa + hormonal ablation versus hormonal ablation alone) multicenter clinical study evaluating the efficacy of zometa 4mg given every 3 month as an adjunct to hormonal or surgical castration for prevention of bone metastases in locally advanced, high risk prostate cancer patients, who are hormone-naiv at time of randomization. the primary efficacy variable is the time to occurrence of first bone metastases. zometa® (zoledronic acid) provided as 4mg lyophilised powder supplementation 500mg calcium +400-500iu vitamin d p.o. qd arm a: zometa® (zoledronic acid) in 100ml of calcium free solution i.v. as a 15 minute infusion every 3 months arm b: no reference therapy

Eligibility criteria:
inclusion criteria: * signed informed consent * age \> 18 years * histologically confirmed diagnosis of carcinoma of the prostate * ecog performance status of 0, 1, or 2 * no radiological evident bone metastasis (negative bone scan or verification of suspected foci as benign lesions by additional radiological examination) * t3-4 and highest pre-study psa \>20 ng/ml and gleason score = 8 (or gleason grade = 4) * patients with prior prostatectomy or prior local radiotherapy are eligible for this study * patients are destined to receive medical (lhrh analogue) or surgical (orchiectomy) castration and zometa® treatment will start not later than 6 weeks after surgery * patients should be fully recovered from prior interventions where applicable exclusion criteria: * patients with a serum creatinine determination \>265 µmol/l (3.0 mg/dl) * patients that received prior medical (lhrh analogue) castration * current (or previous) evidence of metastatic disease to the bone * history of any other neoplasm within the past five years except for nonmelanomatous skin cancer. * previous hormonal therapy with lhrh agonists or other forms of hormonal ablation * wbc\<3.0x109, anc \< 1500/mm3, hgb\<8.0 g/dl, platelets \< 75 x 109/l * liver function tests \>2.5 uln * prior treatment with zometa® (zoledronic acid) or other bisphosphonates * treatment with calcitonin, mithramycin, or gallium nitrate within 2 weeks prior to the date of randomization (visit 2) * use of other investigational drugs (drugs not marketed for any indication) within 30 days prior to the date of randomization (visit 2) * patients with evidence in the six months prior to randomization of severe cardiovascular disease (defined as uncontrolled congestive heart failure), hypertension refractory to treatment, or symptomatic coronary artery disease uncontrolled by treatment * history of noncompliance to medical regimens and patients who are considered potentially unreliable or incapable of giving informed consent as judged by the investigator.

Keywords: prostate cancer zometa
a phase 1/2, open-label study to evaluate the safety and antitumor activity of medi0680 (amp-514) in combination with durvalumab versus nivolumab monotherapy in participants with select advanced malignancies

Conditions: Select Advanced Malignancies; Kidney Cancer; Clear Cell Renal Cell Carcinoma

Summary: to evaluate the safety and antitumor activity of medi0680 (amp-514) in combination with durvalumab versus nivolumab monotherapy in participants with select advanced malignancies.

this is a multicenter, open-label, phase 1/2 study to evaluate the safety, tolerability, pk, immunogenicity, and antitumor activity of medi0680 in combination with durvalumab or nivolumab monotherapy in adult immunotherapy-naïve participants with selected advanced malignancies.

Eligibility criteria:
inclusion criteria: * must be 18 years or older * eastern cooperative oncology group performance status of 0-1 * adequate organ function * at least 1 prior line of therapy exclusion criteria: * concurrent enrollment in another clinical study, unless in follow-up period or it is an observational study * concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment * prior treatment with immunotherapy

Keywords: select advanced malignancies, kidney cancer, clear cell renal cell carcinoma
a study to assess the safety of pf-05335810 in hypercholesterolemic subjects

Conditions: Hypercholesterolemia

Summary: this study is to evaluate the safety, tolerability and immunogenicity of single, ascending or multiple fixed subcutaneous and intravenous administrations of pf 05335810 to hypercholesterolemic subjects when added on to a daily statin dose.


Eligibility criteria:
inclusion criteria: * on stable daily doses of a statin for 45 days prior to receiving study treatment. * fasting ldl c equal or greater than 80 mg/dl at screening and visit approximately 1 week prior to randomization. exclusion criteria: * history of a cardiovascular or cerebrovascular event or procedure within one year of randomization. * poorly controlled type 1 or type 2 diabetes mellitus (defined as hba1c \>9%).

Keywords: high cholesterol dyslipidemia
intrapartum translabial ultrasonography reliability

Conditions: Labour;Obstructed; Progression; Delivery Problem for Fetus; Ultrasound Therapy; Complications

Summary: in a present study vaginal examination of the fetal head station is compared with transperineal ultrasonography evaluation of fetal head station and the ability of ultrasonography evaluation in predicting the time and mode of delivery will be investigated.

the sonographically measured head station, 'itu station', was measured along the longest visible axis of the fetal head, between the intersections with the infra pubic line and the deepest bony part of the fetal head, subtracting 3 cm for the level of the ischial spines. this parameter is useful to determine the level of engagement of the fetal head and its progression throughout labor. the labor is divided into a latent phase (stage 0), an active phase (stage 1 and 2), and a third stage defined as the time period between the delivery of the baby and the delivery of the placenta. according to the classic definition, the onset of labor is when regular contractions have been established. the latent phase is characterized by painful contractions and cervical dilatation up to 5 cm in accordance with who. the fetal descent in the birth canal is assessed by vaginal digital examinations and related to the ischial spine. acog has defined five stations above (-5) and below (+5) the level of the spine (0 stations). minus five corresponds to the pelvic inlet, zero to the level of the ischial spine, and plus four corresponds to the pelvic floor. traditionally, labor progression has been assessed by digital examination of cervical dilatation and fetal descent. recent studies, however, dispute these findings and found the clinical examination of fetal descent and position to be unprecise and subjective with a high interobserver variation. dupuis et al. made an important contribution to this debate when he rigorously assessed the accuracy of station diagnosis with digital examinations. . this study provides evidence that digital assessment of fetal head station is unreliable. however, a study from 2019 found a good correlation between clinical assessments and ultrasound examinations when only one experienced clinician and one trained ultrasound examiner compared their results. in this study, we aim to evaluate the accuracy of and consistency between vaginal examination and transperineal ultrasound head station measurements.

Eligibility criteria:
inclusion criteria: * at or over 36 weeks pregnant women * pregnant women at the active phase of the first stage of labor * pregnant women at the second stage of labor exclusion criteria: * breech presentation * fetal anomaly * in utero ex fetus cases * trial of labor after cesarean cases * pregnant women at the latent phase of the first sage of labor

Keywords: labor intrapartum ultrasonography head station
characteristics of blood glucose variability in patients with type 2 diabetes mellitus and covid-19

Conditions: COVID-19 Pneumonia; Type2diabetes

Summary: using intermittently scanned continuous glucose monitoring (iscgm) to clarify the characteristics of blood glucose variability parameters in t2dm patients with ncp, guide the formulation of reasonable clinical treatment measures and make timely and reasonable adjustments, improve the prognosis of patients, shorten the length of hospital stay, and reduce medical costs. the goal of this observational study is to investigate the characteristics of blood glucose variability in patients with type 2 diabetes mellitus (t2dm) complicated with novel coronavirus pneumonia (ncp) and its effect on disease progression and prognosis. the main question it aims to answer is:after fully lifting coronavirus disease 2019 (covid-19) pandemic control measures in mainland china in 12/2022, the incidence of covid-19 has increased markedly, making it difficult to meet the general time-in-range (tir) requirement. therefore, the investigators investigated a more clinically practical tir threshold and examined its association with the prognosis of covid-19 patients with type-2 diabetes. participant population/health conditions：participants were equipped with iscgm sensors on admission. according to the outcome, the patients were divided into favorable outcome group and composite outcome group.

patients with ncp who were discharged or died. clinical data and blood glucose variability parameters were collected by computer blood glucose monitoring technology (cgm). time in range (tir), time above target range (tar), time below target range (tbr), mean amplitude of glycemic excursions (mage), absolute mean daily difference (modd) and other indicators were used.

Eligibility criteria:
inclusion criteria: 1. all patients met the diagnostic criteria of type 2 diabetes mellitus in "chinese guidelines for the prevention and treatment of type 2 diabetes mellitus (2020 edition)" formulated by the chinese diabetes society of the chinese medical association, and were previously diagnosed with type 2 diabetes mellitus and newly diagnosed with type 2 diabetes mellitus after admission 2. patients with mild, moderate, severe and critical covid-19 in accordance with the guidelines of "diagnosis and treatment of novel coronavirus infection (trial version 10)" 3. patients receiving cgm or peripheral blood glucose monitoring during hospitalization exclusion criteria: 1. cases with incomplete data 2. non-ncp and non-t2dm patients 3. patients who did not receive cgm or peripheral blood glucose monitoring
effect of gastric cancer specialist training program in laparoscopic gastric cancer surgery（stp-lrg-1）

Conditions: Gastric Cancer

Summary: to prospectively evaluate the effect of the gastric cancer specialist training program of fujian medical university union hospital on laparoscopic gastric cancer surgery.

laparoscopic gastric cancer surgery has the advantages of less trauma, quick postoperative recovery, less postoperative pain symptoms, less postoperative complications, and shorter average hospital stay. in addition, the surgical safety and oncological efficacy of laparoscopic radical gastrectomy for gastric cancer have been obtained. confirmed by numerous clinical studies. however, due to the difficult operation, complex anatomy and high technical requirements of laparoscopic gastric cancer surgery, the operator needs to have rich experience in laparotomy, skilled laparoscopic operation skills, and the ability to actively prevent and deal with complications after surgery. therefore, at this stage, laparoscopic radical gastrectomy for gastric cancer is only suitable for large hospitals with certain conditions, and it should be gradually carried out on the basis of chief surgeons with rich clinical experience in radical gastrectomy and skilled laparoscopic technical experience. the gastric cancer specialist training program (stp-lrg-1) of fujian medical university affiliated union hospital (stp-lrg-1) has more than 9 years of trainee training experience. the effectiveness of stp-lrg-1 has not been prospectively evaluated, so this study aimed to prospectively evaluate whether stp-lrg-1 can improve the surgical skills of trainees and ultimately improve short-term outcomes for patients during and after surgery

Eligibility criteria:
inclusion criteria: 1. the title of fellow physician or above, with experience in performing laparoscopic radical gastrectomy for gastric cancer independently or under supervision; 2. the hardware facilities and staffing of the operating room support the completion of laparoscopic gastric cancer surgery; 3. surgical videos of laparoscopic radical gastrectomy before and after the training required for this study can be provided; 4. clinicopathological data, intraoperative and postoperative short-term outcome data of the patients operated by the surgeon before and after training can be provided; 5. informed consent exclusion criteria: 1. refuse to carry out laparoscopic gastric cancer surgery; 2. due to the limitations of equipment or policies, the unit cannot routinely carry out laparoscopic gastric cancer surgery; 3. those who have not performed laparoscopic gastric cancer surgery within 1 month before participating in the training and cannot provide video; 4. those who are not expected to perform laparoscopic gastric cancer surgery within 1 month after participating in the training; 5. participate in other clinical investigators during the same period.
bubble pep training among patient with chronic obstructive pulmonary disease in pulmonary function effects

Conditions: Chronic Obstructive Pulmonary Disease With Exacerbation; Chronic Obstructive Pulmonary Disease Exacerbation; Chronic Pulmonary Disease

Summary: the morbidity rate of chronic obstructive pulmonary disease (copd) is increasing year by year. it is predicted to be the third leading cause of death worldwide in 2030. people with copd have a high risk of needing a ventilator due to the decline of lung function, the increase of secretions, the dysfunction of airway clearance, and the obstruction and loss of alveolar elasticity.

this study aimed to explore the effectiveness of cough and sputum assessment and respiratory physiological indicators after training with the bubble positive expiratory pressure (bubble pep) inpatients with copd. this is a randomization control trial design survey using convenient sampling and will be to select 94 inpatients with copd in the division of chest ward of two teaching hospital in new taipei city. the subjects who meet the conditions for admission are explained, and they need to sign a consent form confirming that they understand the risks. more, they are randomly divided into the experimental group (experimental group n=47) and the control group (control group n=47). the experimental group receives the bubble pep training; the control group receives the division of chest ward routine care. the study employs a structured questionnaire including a basic demography, copd domain, copd assessment test (cat), cough and sputum assessment test, and check the peak expiratory flow rate (pefr) using it for data collection. the study needs to be approve by the institutional review board. the two groups agreed to participate in the study, after completing the subject consent form before the intervention, they also received the pre-test as a benchmark for the intervention effect. after completing the 7-day and 30-day intervention, the post-test was performed immediately to understand the intervention immediate effect.

Eligibility criteria:
inclusion criteria: 1. hospitalized patients diagnosed with copd 2. over 40 years old 3. awareness and ability to read articles 4. agree to participate in this research and sign the research consent form exclusion criteria: 1. use non-invasive positive pressure breathing apparatus 2. have received positive pressure breathing therapy before or during hospitalization 3. people with mental illness 4. coughing up blood, pneumothorax 5. suffer from legally infectious respiratory diseases 6. pregnant women 7. reject the subject

Keywords: copd, bubble pep, pulmonary function
phenotyping asthma for bronchial thermoplasty

Conditions: Severe Asthma

Summary: this study will evaluate a new imaging technology, called optical coherence tomography (oct) to examine the asthmatic airways before and after bronchial thermoplasty, which is a new treatment option for severe asthmatic patients. the aim of this study is to learn more about how airways respond to this new treatment. in the future the investigators hope oct will aid clinicians in the initial assessment, management and long-term follow up of patients receiving bronchial thermoplasty.

asthma currently affects over 300 million individuals worldwide and the number of the affected patient is continuously increasing. approximately 10% of asthmatics have poorly controlled, severe symptoms. the exact mechanisms behind the development of asthma are unknown. however, the excessive contraction of airway smooth muscle leading to airway constriction is thought to be responsible for the majority of the symptoms of asthma. a new treatment option, termed bronchial thermoplasty, can offer relief for individuals with severe asthma. bronchial thermoplasty works by reducing smooth muscle with thermal energy. this new imaging technology, called optical coherence tomography (oct) is the first imaging modality that is capable to visualize airway smooth muscle in humans. in this study the investigators will examine the asthmatic airways before and after bronchial thermoplasty to learn about how airways respond to this treatment. the long term goal of this study is to use oct to look at the airways with the hope of helping clinicians monitor and predict the response to bronchial thermoplasty. during the scheduled bronchial thermoplasty procedure, oct imaging will be performed. the study imaging will add less than 10 minutes to the time required for the standard procedure.twelve months following the completion of bronchial thermoplasty, the investigators will ask the participants to return to the hospital to undergo follow-up tests including a ct scan and a bronchoscopy procedure with repeat oct imaging. the investigators expect these test to be accomplished in 2 additional visits.

Eligibility criteria:
inclusion criteria: 1. patient undergoing elective bronchial thermoplasty 2. patient is between the ages of 18 and 60 3. patient is able to give informed consent 4. negative pregnancy test for all female of childbearing potential who are sexually active and not using contraception, are seeking to become pregnant, or who are nursing. 5. nonsmoking (\<5 pack year tobacco exposure) 6. no history of co-existing lung disease 7. meet american thoracic society criteria for diagnosis of asthma with either/or 1. bronchodilator response to albuterol (≥12% change in fev1) 2. positive methacholine bronchoprovocation (pc20 \< 25 mg/ml) exclusion criteria: 1. patients who are pregnant. 2. patient does not meet the requirements to undergo clinical bronchial thermoplasty, as determined by the treating physician

Keywords: optical coherence tomography bronchial thermoplasty
safety of insulin detemir in children with type 1 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 1

Summary: this trial is conducted in japan. the aim of trial is to investigate the safety of insulin detemir and insulin nph in children with type 1 diabetes.


Eligibility criteria:
inclusion criteria: * type 1 diabetes for at least one year * current treatment of basal-bolus regimen for at least 12 weeks using an intermediate/long-acting human insulin and insulin aspart and/or soluble human insulin * hba1c below 11.0% * willing to comply with investigator's instructions * able and willing to perform self-monitoring of capillary blood glucose and to take measures in case of hypoglycaemia exclusion criteria: * impaired renal function * impaired hepatic function * known hypoglycaemia unawareness or recurrent major hypoglycaemia (as judged by the investigator or sub-investigator) * proliferative retinopathy or maculopathy requiring acute treatment * uncontrolled treated/untreated hypertension * current treatment with total daily insulin dose of more than 2.00 iu/kg * current treatment or expected at the screening to start treatment with systemic corticosteroids
pharmacokinetics of thymoglobulin in paediatric haematopoietic stem-cell transplants

Conditions: Malignancy; Metabolic Disease; Genetic Disorder

Summary: this study will describe the pharmacokinetic disposition of biologically active rabbit anti-thymocyte globulin (ratg) after a consistent dose of 7.5 mg/kg/course given as part of the conditioning regimen in children undergoing hematopoeitic stem cell transplantation (hsct).

allogeneic hematopoeitic stem cell transplantation (hsct) is a therapeutic option for patients with malignancies as well as metabolic and genetic diseases. conditioning regimens given prior to donor cell infusion aim to ablate the recipient bone-marrow, to allow engraftment of the stem-cells infused, and to prevent acute versus host disease (agvhd). anti-thymocyte globulin (atg) is one of the immunosuppressive drugs given as a preparative regimen for hsct. subjects will be given an atg infusion daily for 3 days prior to hsct and serum levels will be collected, as per schedule, with the last sample taken +100 days post-hsct.

Eligibility criteria:
inclusion criteria: * all patients who are scheduled to receive atg 2.5mg/kg/day for 3 days as part of the preparative regimen for hsct, as determined by the responsible hsct physician. * written, informed consent exclusion criteria: * hypersensitivity to rabbit proteins or to any product excipients * active acute or chronic infections, which would contraindicate any additional immunosuppression * known pregnancy or breastfeeding

Keywords: allogeneic hematopoietic stem cell transplantation pharmacokinetics pediatrics