Kornimate/medical-research-clean huggingface dataset:
combination study of rmc-4630 and sotorasib for nsclc subjects with krasg12c mutation after failure of prior standard therapies

Conditions: Non-Small Cell Lung Cancer

Summary: the purpose of this study is to evaluate the antitumor effects of sotorasib and rmc-4630 in subjects with krasg12c mutant nsclc

this is a phase 2 multicenter, open-label study evaluating the efficacy, safety, tolerability, and pharmacokinetics (pk) of rmc-4630 in combination with sotorasib in subjects with krasg12c mutant nsclc after failure of prior standard therapies.

Eligibility criteria:
inclusion criteria: * subject must be ≥18 years of age. * subject must have pathologically documented, locally advanced or metastatic krasg12c nsclc (not amenable to curative surgery) that has progressed on prior standard therapies (no more than 3 prior lines of therapies are allowed) exclusion criteria * primary central nervous system (cns) tumors * known or suspected leptomeningeal or brain metastases or spinal cord compression * clinically significant cardiac disease * known impairment of gi function that would alter the absorption * active autoimmune disease requiring systemic treatment within past 2 years * history of severe allergic reactions to any of the study intervention components * major surgical procedures within 28 days or non-study-related minor procedures within 7 days of treatment. * prior therapy with krasg12c inhibitor and/or shp2 inhibitor

Keywords: shp2 nsclc kras g12c braf class 1/2/unclassified kras amplification kras mutation stk11/lkb1 keap1 pik3ca atrx brca2 carcinoma, non-small lung cancer bronchial neoplasms lung neoplasms respiratory tract neoplasms neoplasms by site neoplasms lung diseases respiratory tract diseases
ovarian tissue cryopreservation for fertility preservation

Conditions: Infertility

Summary: to provide a novel fertility preservation option for patients facing a fertility threatening cancer diagnosis or treatment regimen by establishing an ovarian tissue cryopreservation program. to determine if ovarian tissue cryopreservation provides women with a useful, successful option for fertility preservation the hypothesis is that ovarian tissue cryopreservation for fertility preservation provides an alternative option for fertility preservation.


Eligibility criteria:
inclusion criteria: * will undergo surgery, chemotherapy, drug treatment and/or radiation for the treatment or prevention of a medical condition or malignancy which are likely to result in permanent loss of subsequent ovarian function or diminished fertility * have a medical condition or malignancy that requires removal of all or part of one or both ovaries * patients may have newly diagnosed or recurrent disease * be in good health so as to be able to undergo laparoscopic surgery as determined by history and physical examinations, and consultation with the medical oncologist, reproductive endocrinologist, surgeon and anesthesiologist exclusion criteria: * moderate to high-risk of ovarian failure due to treatment * documented ovarian metastasis * hiv or hepatitis (b, c)-positive serology * absolute surgical contraindications * ecog performance status of 0 or 1 * pregnancy * women with psychological, psychiatric, or other conditions which prevent giving fully informed consent

Keywords: fertility preservation ovarian tissue cryopreservation assisted reproductive technology
the effect of portion sizes on mood

Conditions: Mood; Eating Patterns

Summary: the purpose of this study is to investigate whether different portion sizes will effect overall mood.

the objective of this investigation is to determine whether participants will have a change in mood based on the portion size of foods served. the specific aims of the study are: 1. determine the effect of increasing portion sizes on mood. 2. determine the effect of decreasing portion sizes on mood.

Eligibility criteria:
inclusion criteria: * age 18-35 * have a body mass index of 18.5 and 24.9 kg/m\^2 * be an unrestrained eater( scoring less than 12 on the three factor eating questionnaire) * report being a non-smoker exclusion criteria: * currently pregnant or nursing * report being an athlete in training * currently taking any medications that affect appetite or food intake * have a medical condition affecting eating or are currently following a therapeutic diet * report disliking foods used in the investigation * report having allergies to foods used in the investigation

Keywords: snack food (chips) fruit (red grapes) consumed in each condition mood
evaluation of the efficacy of non-drug therapy (sms intervention) for adolescents with nssi

Conditions: Non-suicidal Self-injury

Summary: in this proposed study, text messages are used to intervene in the nssi behavior of adolescents, and the efficacy of this intervention method is evaluated, as well as the internal mechanism of adolescents' nssi behavior is discussed.

in this proposed study, the investigators will evaluate the effect of text message intervention on nonsuicidal self-injury behavior in adolescents. the study will recruit 110 adolescents with nonsuicidal self-injury behavior in outpatient and ward, then all the participants will be randomized to the intervention group (55 cases) or the control group 55 cases) for an 8-week clinic trial. clinical efficacy and safety assessment will be done at baseline, the fourth week, and the eighth week. the specific aims are to evaluate the effect of text message intervention on nssi in adolescents are on 1) tendency and frequency of nonsuicidal self-injury behavior; 2) level of negative emotion such as depression, anxiety, and hopelessness 3) the use of emotion regulation strategies and coping styles. a semi-structured quantitative interview will be conducted among adolescents from the sms group to get the attitude and experiences feedback about the text message.

Eligibility criteria:
inclusion criteria: 1. adolescents aged 10-19 years old. 2. meet the diagnostic criteria of nssi behavior recommended by dsm-5. 3. the adolescents who have mobile phone, and have the ability to send or receive text messages. 4. adolescents and guardians agreed to participate and signed the informed consent form exclusion criteria: 1. adolescents with severe somatic diseases who cannot complete the study. 2. adolescents with cognitive impairment, neurodevelopmental disorder, mental retardation, visual impairment who cannot complete the study. 3. the adolescents who do not have a mobile phone.
ventilator associated pneumonia and late complications of percutaneous tracheostomy

Conditions: Pneumonia

Summary: the purpose of this study is to investigate the incidence of ventilator associated pneumonia and late complications by comparing two different cannulas and two different percutaneous tracheostomy techniques.

this study did not generate the expectations's we've expected, therefore, the analysis was prematurely stopped...

Eligibility criteria:
inclusion criteria: * all patients on the intensive care unit who receive a tracheostomy. exclusion criteria: * hiv/aids * use of immunosuppressive * with regard to the mri-scan patients who have a pacemaker and/or who are claustrophobic
closm trial: groin closure using layered option for suture material

Conditions: Vascular Diseases

Summary: this is a randomized controlled trial comparing groin closure after vascular intervention with vicryl suture versus pds (polydioxanone) suture. this will be a single center trail performed at ccf main campus. patients will be enrolled in a prospective fashion and will be randomized 1:1 to either pds or vicryl closure. patients undergoing bilateral groin exposure will be randomized to receive both closure types to either groin.

previous research has provided insights into the properties of various suture materials, yet there remains a gap in our understanding of their relative effectiveness in groin closure specifically within the context of vascular surgery. the lack of definitive evidence on whether vicryl or pds (polydioxanone) sutures offer superior outcomes necessitates further investigation. this study aims to address this gap by conducting a head-to-head comparison of these sutures, focusing on their impact on postoperative groin complications. this is a randomized controlled trial comparing groin closure after vascular intervention with vicryl versus pds. this will be a single center trail performed at ccf main campus. patients will be enrolled in a prospective fashion and will be randomized 1:1 to either pds or vicryl closure. patients undergoing bilateral groin exposure will be randomized to receive both closure types to either groin. the primary objective of this randomized controlled trial (rct) is to evaluate the effectiveness of vicryl versus pds sutures in reducing groin complications following vascular surgery.

Eligibility criteria:
inclusion criteria: * all patients \> 18 years who undergo elective vascular surgery that would require groin incisions * patients with to undergo elective bilateral groin incisions will be matched to receive closure with pds in one groin and vicryl in the other groin exclusion criteria: 1. age 17 or younger 2. prisoners 3. pregnant patients 4. emergent cases 5. active groin infection prior to intervention 6. history of prior surgical groin access (re-operative groin) 7. groin closure after extracorporeal membrane oxygenation (ecmo)

Keywords: surgical site complication vascular surgery wound healing
a study to learn about the study medicine (called avelumab) in people with advanced urothelial cancer after chemotherapy

Conditions: Urothelial Cancer

Summary: the purpose of this clinical trial is to learn about the safety and effects of the study medicine (called avelumab) in people with advanced urothelial (bladder) cancer (uc) whose disease hasn't worsened after receiving chemotherapy. this study is seeking participants who: 1. have uc that cannot be operated on or has spread to other parts of the body 2. received 1st line platinum-based chemotherapy and had stable disease, partial response, or complete response to this treatment 3. received avelumab as indicated as the only therapy for the first-line maintenance who are progression-free following platinum-based chemotherapy 4. are 18 years or older on the date that they start taking avelumab all participants in this study will receive avelumab, a standard treatment for urothelial carcinoma. participants will take part in this study for about 4 years. during this time, they will take avelumab as instructed in the real-world setting. we will study the experiences of people receiving the study medicine. this will help us decide if the study medicine is safe and effective.

the primary objective of this study is to estimate real-world overall survival (rwos) in a real-world cohort of patients treated with avelumab monotherapy for the first-line maintenance treatment of adult patients with locally advanced or metastatic uc who are progression-free following platinum-based chemotherapy. the secondary objectives are: 1. to describe the clinical and demographic characteristics of the study population 2. to estimate real-world progression-free survival (rwpfs) 3. to describe treatment characteristics of 1l anti-cancer therapies received prior to the initiation of avelumab as 1lmaintenance therapy 4. to describe treatment patterns after initiation of avelumab as 1l maintenance therapy 5. to describe the adverse events (aes) explicitly attributed to avelumab in a real-world population 6. to describe real-world all-cause associated healthcare resource burden associated with avelumab therapy

Eligibility criteria:
inclusion criteria: 1. patients with a diagnosis of locally advanced or metastatic uc, either de novo or relapsed 2. patients received 1l platinum-based chemotherapy and had stable disease, partial response, or complete response to this treatment 3. patients received avelumab as indicated as a monotherapy for the first-line maintenance treatment of adult patients with locally advanced or metastatic uc who are progression-free following platinum-based chemotherapy 4. patients aged ≥18 years on the date that they commenced avelumab - exclusion criteria: 1. patients whose hospital records are not available for review 2. patients who are receiving an investigational medicinal product as part of a clinical trial at the time of maintenance therapy with avelumab
a prospective study of clinical factors affecting disease progression and treatment results of patients with tumors of the prostate, bladder and kidney.

Conditions: Kidney Cancer; Prostate Cancer; Bladder Cancer

Summary: identifying clinical factors such as medication, background diseases and blood tests that effect the course of disease in cancer patients can help physicians to better decide on the patient's treatment plan. the study seeks to identify and analyze relevant clinical factors that effect the course of the disease and the results of treatment in patients with cancers of the prostate, bladder and kidney.


Eligibility criteria:
inclusion criteria: * all patients with prostate, bladder or kidney cancer that are being treated at the meir medical center and are over 18 years of age. exclusion criteria: * patients under the age of 18

Keywords: kidney cancer prostate cancer bladder cancer
pregabalin effects on hypotensive anesthesia during spine surgery.

Conditions: Spine Surgery

Summary: elective lumbar spine surgical procedures are commonly performed under controlled hypotension during general anesthesia. that is beneficial to limit the intraoperative blood loss and transfusions and improves surgical field. deliberate hypotension could be achieved via various medications but mostly associated with significant side effects. pregabalin effectively augmented hypotensive anesthesia. the hypothesis is that pregabalin 150 mg single preoperative dose may augment intraoperative deliberate hypotension that will be reflected on blood loss and nitroglycerin consumption.

an arterial line will be established then general anesthesia will be conducted. after adequate preoxygenation, anesthesia induction by iv fentanyl 1.5µg/kg, propofol 2 mg/kg, and atracurium 0.5 mg/kg then appropriated size tracheal tube. the ventilator settings will be adjusted to maintain the end-tidal carbon dioxide tension (etco2) at 30-35 mm hg. anesthesia will be maintained by isoflurane concentration 1.2%, with 40% oxygen in air then iv infusion of fentanyl 0.05 mcg/kg/min was started while atracurium 0.1 mg/kg incremental dose as required. then patients will be turned into the prone position above pad support permitting free hanging of the abdomen. intraoperatively, the target mean arterial arterial blood pressure (mbp) is 55-65 mm hg. after surgical incision, if mbp exceeds 65 mm hg (defined as hypertension) it will be managed by: increasing isoflurane mac up to 2%, if no response after 5 min, nitroglycerin infusion initiated at 0.5 mcg/kg/min to 40 mcg/kg/min. hypotension (mbp \<55 mm hg) will be treated by stopping nitroglycerin, proper compensation of losses, reducing isoflurane mac. if persisted; vasoactive drugs will be used. bradycardia (hr \<50 beat/min.), treated with 0.01 mg/kg atropine iv increments. the nitroglycerin infusion will be stopped after the finial surgical hemostasis. fentanyl infusion will be stopped before ligament sutures. isoflurane will be closed after the last surgical suture. after dressing, patient will be turned to the supine position and morphine 0.025 mg/kg iv will be administered then 0.04 mg/kg neostigmine and 0.015 mg/kg atropine for reversal. extubation will be done after establishment of acceptable spontaneous respiration.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists (asa) score i-ii * admitted to undergo lumbar discectomy or spinal fixation surgery under general anesthesia exclusion criteria: * patients on anti-hypertensive treatment, diuretics, corticosteroids, pregabalin, gabapentin, anticonvulsants, antipsychotics, * alcohol addiction or drug abuse * patients with history of allergy to any drug used in the study . * pregnant or nursing women * patients with peripheral neuropathy, endocrinal diseases, bleeding abnormality, * cardiac, hepatic or renal impairment

Keywords: pregabalin, hypotensive anesthesia, blood loss, analgesia
use of direct peritoneal resuscitation in high-risk liver transplant recipients

Conditions: End Stage Liver DIsease; Obesity; Acute Kidney Injury

Summary: this study is being conducted to assess the safety of direct peritoneal resuscitation (dpr) in high-risk liver transplant patients. the investigators want to also identify if this method of recovery after large surgery has the same benefits in liver transplant patients as have been appreciated in other surgical patients. the combination of elevated bmi and impaired kidney function increases the risk of 1) needing intensive care unit (icu) admission after surgery, 2) slow function of the new liver \[technically termed early allograft dysfunction (ead)\] and 3) need for more than one operation. the study team also aims to identify if dpr can reduce these risks and not cause other unexpected complications following surgery. dpr involves the infusion of a solution into the abdomen and has been shown to reduce edema and improve blood flow in organs. the solution used in this study is a commercially available peritoneal dialysate, a dextrose containing solution that is infused into the abdominal cavity and is routinely used in patients with end-stage renal disease requiring dialysis.

the central hypothesis of this study is that direct peritoneal resuscitation is a safe therapy following liver transplantation and is associated with a reduced rate of return to the operating room. aim 1: determine the safety profile of direct peritoneal resuscitation on liver transplant recipients at risk of return to the operating room and icu admission. hypothesis: liver transplant recipients that receive dpr will have comparable complication rates to historic controls of liver transplant recipients with similar demographics. aim 2: identify if direct peritoneal resuscitation demonstrates a trend towards a reduced rate of return to the operating room compared to historic controls. hypothesis: dpr will demonstrate a trend of a reduce rate of return to the operating room of liver transplant patients after index operation compared to historic controls. aim 3: identify if direct peritoneal resuscitation reduces the rate of early allograft dysfunction and other organ failure following liver transplantation with interval improvement in post-operative fibrinolysis activity. hypothesis: dpr will reduce the rate of ead of liver transplant patients compared to historic controls and is associated with increased fibrinolysis in the post-operative period.

Eligibility criteria:
inclusion criteria: * adult liver transplant recipients ≥18 y/o * ability to consent * pre-operative creatinine ≥1.1 (or on dialysis) and bmi ≥30 exclusion criteria: * diaphragmatic injury * active spontaneous bacterial peritonitis (sbp) with initiation of antibiotic treatment within 72 hours of surgery

Keywords: liver transplant obesity renal failure
association between knee isokinetic testing and lower limb functional performance and limb symmetry

Conditions: Proprioceptive Disorders

Summary: this study aimed to evaluate the association between the isokinetic knee strength and/or proprioception performance with the functional performance on the functional hop-tests and y-balance test. this study included 20 healthy individuals who performed an isokinetic assessment of knee proprioception (joint position sense, jps and threshold to detection of passive motion, tdpm) and flexors/extensors strength. at the same time, they performed a functional testing consisting of three hop-tests (single, triple and cross-over) and the lower quarter y-balance test (ybt-lq). we tested the correlation between the isokinetic and functional performances, and limb symmetry indexes.


Eligibility criteria:
inclusion criteria: * individuals under 45 years of age who performed at least 4 hours of physical activity per week. exclusion criteria: * individuals unable to perform isokinetic muscle tests * individuals with a current or recent lower limb injury with time loss from sport participation within the previous month * individuals with previous severe knee injury (eg. severe ligament tear, knee fracture) * individuals taking medications with potential balance/coordination side effects.
covid-19 virtual recovery study

Conditions: Covid19

Summary: the purpose of this study is to determine the effects of respiratory muscle training (rmt) and nasal breathing on patients who have been infected with the sars-cov2 virus and continue to have lingering symptoms.

this study will be conducted virtually and will be completed at home using a cell phone application. study participation involves the use of a rmt device, and/or nasal breathing. the purpose of this research is to evaluate the impact of rmt and nasal breathing on chronic symptoms of covid-19 in patients that have recovered from sars-cov2. subjects that have tested positive for the sars-cov2 infection and have completed a 14 to 30 day quarantine will be recruited.the rmt device will be used up to 2 times a day at a moderate intensity for 2 or 3 sets of 10 or 15 repetitions. additionally, 2 sets of 10 nasal breathing techniques will be performed twice a day without the rmt device. subjects will complete several surveys examining symptoms, physical activity, cognitive function, and quality of life at baseline, 2 weeks, and 4 weeks. subjects will also perform phonation (speaking/speech sounds) and sit to stand tests at baseline, 2 weeks, and 4 weeks. all data will be collected through the use of a cell phone application. the cell phone application will also provide subjects with the proper rmt protocol. additionally, subjects will receive coaching and instructions on how to use the breathing device, as well as instructions on how to complete the phonation and sit to stand test.

Eligibility criteria:
inclusion criteria: * positive test for sars-cov2 within the last 3 months. * smartphone user. * english speaker. * age 18 or above. * us resident. exclusion criteria: * hemodynamic instability. * contraindications or inability to perform rmt. * inability to navigate study questionnaires or tasks. * history of kidney disease, arteriosclerosis obliterans, and high calcium levels.

Keywords: respiratory muscle training covid-19 long hauler syndrome long covid nasal breathing