Kornimate/medical-research-clean huggingface dataset:
part 1 - a clinical trial in patients with frequently relapsing and steroid-dependent nephrotic syndrome

Conditions: Nephrotic Syndrome

Summary: a clinical trial investigating the safety and efficacy of adx-629 in subjects with frequently relapsing and steroid-dependent nephrotic syndrome

adx-629-mcd-001 is a multi-center, two-part, phase 2 clinical trial designed to evaluate the safety and efficacy of adx-629 in subjects with frequently relapsing and steroid-dependent nephrotic syndrome. study drug will be administered orally every 12 hours (twice daily) to eligible subjects for 90 days. the study will enroll approximately 35 children and adults with nephrotic syndrome who have had a nephrotic relapse in the 6 months prior to screening. the clinical trial is divided into 2 parts: part 1 (open-label) and part 2 (double-blinded, randomized). part 1: approximately 5 eligible subjects will receive open-label adx-629 (250 mg) twice daily for 90 days. part 2: approximately 30 eligible subjects will be randomized in a 2:1 ratio to receive either adx-629 (250 mg) or matching placebo twice daily for 90 days. patients who are interested in participating will be provided detailed information about the study including description of study assessments/procedures, possible side-effects, alternative treatments, and potential benefits.

Eligibility criteria:
inclusion criteria: * adults ≥18 years of age * history of nephrotic syndrome, characterized by heavy proteinuria and hypoalbuminemia * recent nephrotic relapse in the 6 months prior to screening * estimated glomerular filtration rate (egfr) of ≥45 during screening * not pregnant, breastfeeding, or lactating and agree to use a highly effective method of acceptable contraceptive for the trial duration, if applicable exclusion criteria: * subjects with collapsing fsgs focal segmental glomerulosclerosis (fsgs) * known secondary cause of nephrotic syndrome (e.g., diabetic nephropathy, systemic lupus erythematous, sickle cell anemia, malignancy, drug-induced, malaria) * history of kidney transplantation or other solid organ transplantation * history of any unstable chronic diseases/conditions, clinically significant abnormalities, or findings, that in the opinion of the investigator, could compromise subject safety or affect the conduct of the trial

Keywords: idiopathic nephrotic syndrome focal segmental glomerulosclerosis (fsgs) minimal change disease frequently relapsing nephrotic syndrome adx-629 reactive aldehyde species (rasp) chronic kidney disease
a study of parsaclisib, a pi3kδ inhibitor, in combination with bendamustine and rituximab in patients with newly diagnosed mantle cell lymphoma

Conditions: Mantle Cell Lymphoma

Summary: this is a phase 3, double-blind, randomized, placebo-controlled, multicenter study of parsaclisib plus br versus placebo plus br as first-line treatment of participants with newly diagnosed mcl.


Eligibility criteria:
inclusion criteria: * male and female participants aged 18 years or older. (japan aged 20 years or older.) * have received no previous systemic anti-lymphoma therapies. * pathologically confirmed mcl by local laboratory. * histologically confirmed cd20 expression (by flow cytometry or immunohistochemistry) of the mcl cells as assessed by pathology. * ineligible for high-dose chemotherapy and autologous stem cell transplantation. * radiographically (ct, mri) measurable lymphadenopathy per the lugano criteria for response assessment (cheson et al 2014). * ecog ps of 0 to 2. * willingness to avoid pregnancy or fathering children. exclusion criteria: * presence of any lymphoma other than mcl. * presence of cns lymphoma (either primary or secondary) or leptomeningeal disease. * requires treatment with potent inducers and inhibitors of cyp3a4 * inadequate organ functions including hematopoiesis, liver, and kidney significant concurrent, uncontrolled medical condition, including, but not limited to, renal, hepatic, hematological, gi, endocrine, pulmonary, neurological, cerebral, or psychiatric disease. * history of other malignancy within 2 years of study entry. * known hiv infection, hbv or hcv. * hbv or hcv infection: participants positive for hbsag or anti-hbc will be eligible if they are negative for hbv-dna; these participants must receive prophylactic antiviral therapy. participant's positive for hcv antibody will be eligible if they are negative for hcv-rna. * clinically significant cardiac disease, congestive heart failure, including unstable angina, acute myocardial infarction, or cardiac conduction issues, within 6 months of randomization. * abnormal ecg findings that are clinically meaningful per investigator's assessment. * women who are pregnant or breastfeeding * any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study treatment and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.

Keywords: parsaclisib newly diagnosed bendamuastine rituximab pi3kδ
laparoscopic versus robot-assisted ventral hernia repair: a single institution randomized controlled trial

Conditions: Ventral Hernia

Summary: randomized trial to compare outcomes of robot-assisted and laparoscopic ventral hernia repair surgery.

ventral hernia repair is a very common surgical operation. both laparoscopic and robot-assisted operations are considered acceptable. however, there is no clear indication for a particular approach. no prospective trial has been conducted so far to establish superiority of one approach over the other. the investigator believes each approach has unique characteristics and may offer advantages over the other in the right population group. the investigator will randomly assign patients in two arms according to the surgical approach, whether laparoscopic or robot-assisted. the investigator will collect preoperative characteristics, intraoperative variables, and postoperative outcomes. the investigator will compare all variables to establish differences between the two groups.

Eligibility criteria:
inclusion criteria: * surgeon determined need for ventral hernia repair exclusion criteria: * \ 99 years of age * pregnant * medical indication for open repair

Keywords: robot-assisted
long-term follow-up safety study of human central nervous system stem cells in subjects with geographic atrophy of age-related macular degeneration

Conditions: Age-Related Macular Degeneration; Geographic Atrophy

Summary: this study is being done to determine the long-term safety and possible benefits of transplanted human central nervous system stem cells (hucns-sc) for patients with geographic atrophy of age-related macular degeneration. this long-term follow-up study is limited to those individuals who received a transplant of hucns-sc cells into one of their eyes as part of the cl-n01-amd study. no additional study product will be given in this 4-year long-term follow-up study.


Eligibility criteria:
inclusion criteria: * must have completed study cl-n01-amd * must be able to provide written informed consent prior to any study related procedures * agree to comply in good faith with all conditions of the study and to attend all required study visits exclusion criteria: * inability to comply with study procedures or visits * since enrolling in study cl-n01-amd, have entered, or are about to enter another investigational study that, in the opinion of the principal investigator (pi), might confound study interpretation. * received off-study immunosuppressive agents in the lead-in study or are receiving any immunosuppressive agents since completing the lead-in study

Keywords: amd
a phase iii clinical study of cadonilimab plus sox as perioperative treatment for patients with resectable g/gej adenocarcinoma

Conditions: Gastric and Gastroesophageal Junction (GEJ) Adenocarcinoma

Summary: this study investigates treatment of cadonilimab or placebo combined with sox chemotherapy (oxaliplatin + tegafur-gimeracil-oteracil potassium) given before surgery (neoadjuvant) and cadonilimab or placebo combined with sox chemotherapy after surgery (adjuvant), will work and be safe for the treatment of resectable (removable by surgery) gastric or gastroesophageal cancer.

this trial is a phase 3 study. all patients are resectable gastric or gastroesophageal junction adenocarcinoma, eastern cooperative oncology group (ecog) performance status 0-1.the purpose of this study is to evaluate the efficacy and safety of cadonilimab combined with chemotherapy for perioperative treatment of resectable gastric or gastroesophageal junction adenocarcinoma.

Eligibility criteria:
inclusion criteria: 1. patients with histologically confirmed gastric or gastroesophageal junction adenocarcinoma with resectable disease (clinical stage t3-4an+m0 or t4bnanym0 per ajcc 8th edition). 2. eastern cooperative oncology group (ecog) performance status of 0 or 1 at enrollment. 3. has life expectancy of at least 6 months. 4. availability of tumor sample prior to study entry. 5. patients must undergo radical surgery. 6. has adequate organ function. exclusion criteria: 1. patients with unresectable locally advanced disease or distant metastasis. 2. histopathology or cytology confirmed other pathological types, such as adenosquamous cell carcinoma, squamous cell carcinoma, or gi stromal tumor. 3. current or prior use of immunosuppressive medication within 14 days before randomization. 4. has received prior anti-cancer therapy for the current malignancy. 5. has an active infection requiring systemic therapy. 6. contra-indication to any of the study drugs. 7. has a known additional malignancy that is progressing or has required active treatment within the past 5 years. 8. has an active autoimmune disease that has required systemic treatment in past 2 years. 9. known active hepatitis b or hepatitis c virus infection. 10. has had an allogenic tissue/solid organ transplant.
a study to understand the treatment patterns and patients and their clinical outcomes who are taking palbociclib in a real life setting in israel.

Conditions: Metastatic Breast Cancer

Summary: the purpose of this study is to understand the treatment patterns, patients and their clinical outcomes in a real life setting in israel. this study was done in adult breast cancer patients who have started palbociclib combination treatment as per the national basket of health services in january 2018 until august 2020 for all lines of therapy. this study had included adult patients who were prescribed with palbociclib for their breast cancer which had spread to other parts of the body. patients are followed for around 3.5 years.


Eligibility criteria:
inclusion criteria: * a diagnosis of metastatic breast cancer, based on the national/mhs cancer registry. * newly diagnosed metastatic breast cancer patients and newly treated with palbociclib within 6 months of diagnosis, in any line of treatment in the metastatic setting. * available data on palbociclib treatment for at least 6 months. * continuous healthcare plan enrolment in mhs for at least one year before index date. exclusion criteria: * patients that initiated her2 inhibitors.

Keywords: hormone receptor positive/human epidermal growth factor 2 - negative (hr+/her2-)
treatment of early supraglottic squamous cell carcinoma with advance technologies

Conditions: Supraglottic Squamous Cell Carcinoma; Early Stage (T1-T2, N0-N1,M0)

Summary: in this project, the investigators will realize an observational, prospective, multicentric and international clinical trial, to objectively compare patients with sscc according to 3 arms of treatment: * arm 1: radiotherapy ± chemotherapy * arm 2: trans-oral laser microsurgery (tlm) * arm 3: trans-oral robotic surgery (tors) the main goal is to evaluate the efficacy of each treatment with four classes of outcomes: * the quality of life (qol) before and after each treatment option, using validated questionnaires * oncological outcomes * functional outcomes * economical resources the population will include ct1-t2 /cn0-n1/m0 supraglottic squamous cell carcinoma. the primary outcome is a clinical dysphagia qol evaluation assessed by the md anderson dysphagia questionnaire. secondary outcomes include others qol evaluation, oncological and functional measures and cost parameters. the sample size needs to reach 36 patients per arm (total 108).


Eligibility criteria:
inclusion criteria: * diagnosis of sscc (with histological confirmation) * ct1-t2 / cn0-n1/ m0 according to 8th tnm classification (uicc/ajcc) * with a multidisciplinary tumor board decision according to the nccn or european guidelines * diagnostic imaging (head and neck and pulmonary ct or pet/ct, +/- irm if needed) realized within 1 month before the study inclusion * ≥ 18 years old and able to provide an informed consent * ecog/who performance status ≤ 2 exclusion criteria: * - previous radiotherapy +/- chemotherapy treatment of the head and neck region * previous history of head and neck cancer within 5 years * prior invasive malignant disease unless disease-free for at least 5 years or more, with exception of non-melanoma skin cancer * non-supraglottic or unknown primary site * clinical and radiological signs of nodal extracapsular extension * significant trismus (maximum inter-incisal opening ≤ 35 mm) * pre-existing dysphagia not related to the cancer or the biopsy (from neurological disorders for example) * unable or unwilling to complete quality of life questionnaires * serious medical comorbidities or contraindication for surgery and/or radiation * pregnancy and lactation

Keywords: transoral robotic surgery (tors) transoral laser microsurgery (tlm) intensity modulated radiation therapy (imrt) early squamous cell carcinoma supraglottic
norepinephrine on maternal hypotension after combined lumbar and epidural anaesthesia

Conditions: Maternal Hypotension

Summary: norepinephrine has emerged as a potential alternative for stabilizing blood pressure during spinal anesthesia for cesarean section, purportedly maintaining maternal heart rate and cardiac output more effectively than phenylephrine. however, its application as an intravenous bolus for treating hypotension remains underexplored. consequently, this current investigation aimed to determine the ed50 and ed95 of norepinephrine for managing maternal hypotension during cesarean section. a prospective trial enrolled 100 patients undergoing elective delivery under spinal anesthesia, with norepinephrine dosage determined using the upper and lower sequential distribution method (udm).


Eligibility criteria:
inclusion criteria: inclusion criteria included women undergoing elective caesarean section undergoing combined lumbar and rigid anaesthesia, healthy singleton pregnancies at full term (more than 37 weeks gestation), american society of anaesthesiologists physical status i or ii, body weight between 50-100 kg, height between 150-180 cm, and fasting for more than 8 hours. exclusion criteria: the exclusion criteria included individuals with hypertension, cardiovascular diseases, preeclampsia, arrhythmias, diabetes mellitus, spinal cord malformations, abnormal fetal conditions, and those who declined to participate in the study.

Keywords: norepinephrine maternal hypotension
music after stroke to enhance rehabilitation

Conditions: Stroke, Acute; Expressive Aphasia; Movement, Abnormal; Depressive Disorder

Summary: music that is familiar and preferred by patients has been shown to heighten neuroplasticity and can mitigate these disabilities. therefore, this study seeks to explore the effect of providing patient preferred music to patients in the very early post stroke period (within 24 hours of a left cerebral artery stroke \[lmca\]event) as a complementary modality to usual stroke care.

aim i. the primary aim of master is to identify whether a potential relationship exists between an intervention of participant preferred music, when initiated within the first 24 hours following a left middle cerebral artery stroke, and a reduction in the following disabilities: expressive aphasia, right hand functional deficit and post stroke depression. this aim will serve to address the first research hypothesis and address the relationship between these disabilities are well known sequalae among patients diagnosed with the most common form of stroke, a lmca stroke. participant preferred music within the first 24 hours following a lmca stroke and a reduction in: expressive aphasia, right hand functional deficit and post stroke depression, as these disabilities are well known sequalae among lmca stroke patients. aim ii. the second aim of master is to identify if a relationship exists between an intervention of audible books, when initiated within the first 24 hours following a lmca stroke, and a reduction in the following disabilities: expressive aphasia, right hand functional deficit and post stroke depression. sufficient evidence exists to suggest that although listening to books stimulates cognitive function, the effect of melody and participant engagement in music is far superior to listening to words alone as the inherent rhythmicity of patient-favored music has been shown to strengthen synchronous neuronal connectivity, by modulating dopamine and inducing fine grained neuroanatomical changes in a recovering brain.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of lmca stroke within prior 24 hours * not identified as critically ill * glascow coma scale \> 8 at time of consent * resident of a home with a land line or cell phone * able to speak in english or spanish prior to stroke event * presence of expressive aphasia at time of enrollment. exclusion criteria: * stroke diagnosis other than lmca territory stroke * unable to provide consent by patient or legally accountable person acting on behalf of the patient (healthcare proxy, healthcare power of attorney), patient/ representative * does not speak english or spanish prior to stroke event * have a diagnosis of end stage cancer, or other medical conditions that dramatically increase a risk of mortality within one year * any pre-existing communication disorder (including dementia) * patients that are deemed critically ill will not be included
assessment of safety of air travel in patients with birt-hogg-dube syndrome

Conditions: Birt-Hogg-Dube Syndrome

Summary: the aim of this study is to conduct survey-based assessments for the safety of air travel in patients with birt-hogg-dube syndrome (bhd). the study will enroll patients through the clinic network at rare lung disease consortium (rldc) and through the bhd foundation website. patients will have access to the questionnaire via redcap (an online data management system) and each patient will be provided with a link to complete the survey. the investigators plan on enrolling approximately 100 patients with bhd for the purpose of this study. secondary aims of this study include further characterization of the clinical aspects of disease and to establish a contact registry for these patients, in order to facilitate future studies.


Eligibility criteria:
inclusion criteria: * adult, age 18 or older * english literate * signed, dated informed consent; either given electronically or via paper form * diagnosis of bhd confirmed by either a) the presence of fibrofolliculomas/trichodiscomas on skin biopsy, or b) the presence of pathogenic flcn mutations. exclusion criteria: * inability to give informed consent
evaluation of the shape up rhode island campaign study 5

Conditions: Obesity

Summary: obesity is a major health problem that has reached epidemic levels. efforts are needed to develop cost-effective public health approaches for weight loss and maintenance. one such approach is to develop team-based programs that may motivate people to lose weight and/or increase their physical activity. one such program is entitled shape-up rhode island (suri). the current trial is investigating whether adding both a behavioral intervention delivered online plus automated feedback to self-monitoring would enhance the outcomes of suri participants.

background: given the epidemic of obesity, approaches to weight loss that can be applied on a community, state, or national level are needed. this project is an ongoing evaluation of shape up rhode island (suri) program, a state-wide internet based program involving team-based competition to increase physical activity and achieve weight loss. aim: to enhance the effectiveness of suri utilizing a minimal contact intervention delivered online. design: suri 2009 participants were invited to join a research study focusing on weight loss. interested participants were randomized to two groups including a suri enhanced group (behavioral intervention presented in 12 weekly online presentations, daily self-monitoring, and weekly automated feedback) or a suri standard group (group given a list of previously existing online resources to aid with weight loss).

Eligibility criteria:
inclusion criteria: * overweight or obese * current participant in the shape up ri program weight loss competition exclusion criteria: * none

Keywords: obesity weight loss internet
detecting egfr t790m mutations from circulating tumor cells

Conditions: Non Small Cell Lung Cancer

Summary: the purpose of this research study is to determine if the egfr mutation can be detected in ctcs. ctcs are cancer cells that are shed from solid tumors and float freely in the bloodstream. a device called the ctc-chip has been developed to find ctcs in the blood of patients with cancer. this is an experimental device. using this device, the investigators will test participants' blood to try and find ctcs with the egfr mutation and compare them with the results from the biopsy your doctor has recommended. the long-term goal of this research is to develop a way to test for the egfr mutation that is less invasive than a tumor biopsy.

in order to participate in this study you need to have a diagnosis of nsclc that has spread or is unable to be surgically removed. in addition, your cancer must have an egfr mutation and you must have a scheduled (or recently performed) biopsy to check on the presence of any other mutations related to targeted drug resistance. after you sign consent to participate in this study we will draw a blood sample (three tubes of blood). this is about 6 teaspoons of blood. the number of ctcs in your blood will not be reported to you since it is not known if this number has any meaning or if it impacts your medical care in any way. these results will not become part of your medical record. they will be kept in a separate, secure location. we will collect information from your medical records and store it in a research record that we create about you. the study team will use this information to compare details about your medical history with the results of the experiments done on your blood. genetic material (dna) will be removed from the ctcs found in your blood. this genetic material will be stored at the massachusetts general hospital and studied along with samples from other participants on this research study. your samples will not be labeled with your name or any information that identifies you. your samples will have a study-specific code number on them. the code linking your name to the sample will be kept in a secure location, available only to the investigators of the study and select study team members. after the blood draw we will follow your status every 6 months by reviewing your medical records.

Eligibility criteria:
inclusion criteria: * histologically confirmed nsclc that is metastatic or unresectable * have agreed to undergo a clinically recommended invasive repeat tumor itssue biopsy exclusion criteria: -

Keywords: advanced egfr mutation