Kornimate/medical-research-clean huggingface dataset:
predict trial: prospective evaluation of ntm disease in cystic fibrosis

Conditions: Cystic Fibrosis

Summary: isolation of nontuberculous mycobacteria (ntm) from the sputum of individuals with cf is an increasingly common finding, and the lack of an evidenced-based approach to the diagnosis of ntm disease has been identified as one of the greatest unmet needs within the cf community. current evidence predicts that the prevalence of ntm will remain relatively high in the cf population. approaches to ntm disease diagnosis differ widely between centers. this study is observational and follows current best practices. the study will help standardize the diagnosis and collect relevant data associated with the diagnosis of ntm disease to build a framework for future therapeutic trials.


Eligibility criteria:
inclusion criteria: 1. written informed consent (and assent when applicable) obtained from participant or participant's legal representative 2. enrolled in the cff patient registry (cff pr) 3. be willing and able to adhere to study procedures in the context of clinical care, and other protocol requirements 4. male or female participant ≥ 6 years of age at enrollment 5. diagnosis of cf consistent with the 2017 cff guidelines 6. ntm positive for a species or sub-species in the 2 years prior to enrollment that has never been treated. 7. willing to discontinue chronic azithromycin use for the duration of the study exclusion criteria: 1. prior or ongoing antibiotic treatment of the same ntm species or sub-species for which the patient is being considered for this study 2. history of solid organ or hematological transplantation 3. has any other condition that, in the opinion of the site investigator/designee, would preclude informed consent or assent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving the study objectives

Keywords: nontuberculous mycobacteria
beyond mars: magnetic resonance study: a novel assessment of placental perfusion during pregnancy

Conditions: Placenta Diseases

Summary: the purpose of this study is to evaluate the flow of oxygen and blood necessary for nutrient transfer across the placenta during the second and third trimesters in pregnancy in women who are obese before pregnancy compared to women who have an average weight before pregnancy. this study will evaluate blood flow across the placenta by functional magnetic resonance imaging (fmri) using arterial spin labeling (asl). the investigators hypothesize that there will be differences in placental oxygenation and blood flow among women with obesity as compared to those with normal weight. participants will be asked to complete magnetic resonance imaging scans (mris), the first in the second trimester at 20-24 weeks and the second in the third trimester at 30-34 weeks.

the transfer of oxygen and nutrients from the mother to the baby across the placenta is essential to successful pregnancy outcomes. conversely, poor transfer of oxygen from the mother to the baby through the placenta is associated with adverse outcomes, including poor fetal growth, preterm delivery, and stillbirth. babies need oxygen to maintain good health. babies born to women who are obese before pregnancy have a higher risk of experiencing health problems in pregnancy and long-term health problems such as metabolic syndrome, obesity, and diabetes. obesity has continued to increase in the united states over the past decades, and a quarter of pregnancy complications, such as preterm birth, gestational diabetes, hypertension, and large gestational infants, can be attributed to maternal obesity. in this study, the investigators propose using a novel method, arterial spin labeling (asl)) to measure placental blood flow. the study aims to evaluate the feasibility and reliability of assessing placental blood flow by this novel method. the investigators will also evaluate the mean global placental perfusion of second and third trimester placentas among obese women as compared to those with a normal weight before pregnancy. to provide an innovative and comprehensive evaluation of placental oxygen delivery and insights into the delivery of nutrients, investigators will compare global placental perfusion of second and third trimester placentas with measurements of placental oxygenation by r2\* relaxation rates.

Eligibility criteria:
inclusion criteria: * singleton pregnancy exclusion criteria: * multifetal gestation * congenital anomaly * claustrophobia, or ineligible for mri (incompatible implanted medical device)

Keywords: placental perfusion placental oxygenation
gestational diabetes mellitus: "placental-maternal crosstalk and future health"

Conditions: Gestational Diabetes; Cardiovascular Diseases; Placenta Diseases

Summary: the gap study is designed to close important knowledge gaps by: 1. exploring placental health and cellular ageing in gdm and the association with neonatal outcome 2. evaluating the effectiveness of current and novel maternal health follow-up strategies after gdm

the incidence of gestational diabetes mellitus (gdm) is increasing. gdm has potential adverse short and long term health effects for both the women and her offspring, and involves dysfunctional interaction between placenta and the maternal body. the burden for the individual, the health system and society warrants further investigations into the placental-maternal crosstalk in gdm in order to improve personalized pregnancy surveillance and follow-up. in oslo county, nearly twice as many women who give birth suffer from gdm (5.7%) than from preeclampsia (2.3%). the large obstetric department at ullevål provides an optimal environment for novel translational studies and clinical practical aspects of gdm. the gap study is designed to close important knowledge gaps by: 1. exploring placental health and cellular ageing in gdm and the association with neonatal outcome 2. evaluating the effectiveness of current and novel maternal health follow-up strategies after gdm

Eligibility criteria:
inclusion criteria: * pregnant women \>18 years with gdm giving birth at oslo university hospital ullevål. * control group of gestational age matched euglycemic, normotensive pregnancies exclusion criteria: * reduced fetal movements, * epilepsy * thyroidea dysfunction * hypertensive disorder of pregnancy * non-communicable disease * communicable disease (such as hiv) * type 1 or type 2 diabetes. * not able to understand norwegian or english. * under legal guardianship.
trial of oncaspar® and three doses of pegylated recombinant asparaginase in adult patients with newly diagnosed acute lymphoblastic leukaemia

Conditions: Acute Lymphoblastic Leukaemia

Summary: this is an assessment of efficacy and safety of three different doses of pegylated recombinant asparaginase (peg-rasnase) in comparison to oncaspar® during treatment of adults with de novo acute lymphoblastic leukaemia (all). this study will provide first data for determining specific asparaginase doses to yield various durations of l-asparagine (asn) depletion which are required within different treatment phases of all therapy.


Eligibility criteria:
inclusion criteria: * previously untreated acute lymphoblastic leukaemia (pro-b, common, pre-b, early t, thymic t, mature t) * age 18 years - 55 years * treatment according to german multicenter trials for adult acute lymphoblastic leukaemia (gmall) 07/2003 protocol or subsequent gmall protocols for patients with de novo all * written informed consent * women of child-bearing potential or partner of men with child-bearing potential must use a highly effective method of contraception * negative pregnancy test for women of child-bearing potential exclusion criteria: * patients with philadelphia chromosome (bcr-abl) positive all * severe comorbidity or leukaemia-associated complications * known hypersensitivity to asparaginase * history of severe pancreatitis * history of thrombosis or pulmonary embolism * pre-existing clinically relevant coagulopathy * liver dysfunction (e.g. acute or current hepatitis, alcohol or drug abuse) or history of clinically relevant liver disease * bilirubin \> 1.5 x upper limit norm (uln) * other current malignancies * severe psychiatric illness or other circumstances which may compromise the cooperation of the patient or the ability to give informed consent * body mass index \> 30 kg/m² * known pregnancy, breast feeding

Keywords: asparaginase all
a phase 2 study to evaluate the safety and efficacy of ctp-499 in type 2 diabetic nephropathy patients

Conditions: Type 2 Diabetes Mellitus; Chronic Kidney Disease

Summary: this study is being conducted to evaluate the safety and efficacy of treatment with ctp-499 for 24 weeks in patients with chronic kidney disease, type 2 diabetic nephropathy and who are currently receiving treatment with an angiotensin converting enzyme inhibitor (acei) and/or angiotensin ii receptor blocker (arb).

there are two parts to this study, each part includes double-blind treatment with either ctp-499 or placebo. part 1 will evaluate the safety and efficacy of treatment with ctp-499 twice daily for 24 weeks. part 2 will evaluate the effects of longer term dosing for an additional 24 weeks. following part 2, patients will be allowed to participate in an open label extension with ctp-499 for a period of an additional 48 weeks.

Eligibility criteria:
inclusion criteria: * male or female 18 years or older * patient diagnosed with type 2 diabetes mellitus and chronic kidney disease * on a stable regimen of ace inhibitors and/or arb drugs for a minimum of 4 weeks * not expected to start dialysis for one year * patient has blood pressure less than or equal to 145/90 mm hg * patient has uacr greater than or equal to 200 mg/g if male and 300 mg/g if female but not more than 5000 mg/g * patient has glycosylated hemoglobin a1c less than or equal to 10.5% exclusion criteria: * patient has concurrent condition such as uncontrolled inflammatory disease, acute infection or other unstable illnesses * patient has a history of allergy or sensitivity to pentoxifylline or methylxanthines * patient has acute, active and/or unstable renal impairment or has been hospitalized for acute renal failure within the previous year * patient has active malignancy or history of neoplastic disease * patient has a qtc interval greater than 450 milliseconds * patient has alt or ast greater than 3 times the upper limit of normal or a potassium greater than or equal to 5.5meq/l at screening * patient is breast feeding or pregnant

Keywords: type 2 diabetes chronic kidney disease
optimizing vitamin d status during initial military training

Conditions: Bone Health; Nutrition Status

Summary: the primary objective of this randomized, double-blind, placebo-controlled trial is to determine the effect of vitamin d and calcium supplementation (800iu and 2000mg, respectively) on biochemical indicators of nutritional status and bone health in military personnel during army basic combat training (bct) and air force basic military training (bmt). the investigators hypothesize that daily supplementation with vitamin d and calcium during military training will improve vitamin d status, stabilize pth levels, and result in improvements in markers of bone health. as a result of the investigators study design, the findings will provide critically important data regarding the concentration of vitamin d in blood necessary to stabilize pth levels and to optimize bone formation during initial military training.

vitamin d is an essential nutrient for maintaining bone health. previous work from our laboratory indicates that vitamin d status may decline in soldiers during bct, even during the summer months in the southeastern united states. stress fractures may affect up to 5% of male and 21% of female soldiers during training, resulting in attrition in up to 60% of affected personnel, but a recent report indicates that vitamin d and calcium supplementation may attenuate stress fracture risk by up to 20% in female navy recruits. however, biochemical measures of nutritional status and associated markers of bone health were not collected in that study, leaving questions regarding the vitamin d and calcium requirements for military personnel during periods of elevated bone turnover.

Eligibility criteria:
inclusion criteria: * female or male us army or us air force recruits * participating in basic combat training or basic military training, respectively exclusion criteria: * pregnant or breastfeeding * history of kidney stones or kidney disease

Keywords: vitamin d calcium parathyroid hormone bone bone formation bone resorption micronutrients trace elements
steps against the burden of parkinson's disease - stepup

Conditions: Parkinson Disease

Summary: the goals of our stepup project are: 1. to understand the kinematic and neural mechanisms underlying walking improvements due to treadmill training with and without vr-enabled gait adaptations in people with pd; 2. to assess to what extent improvements in walking due to treadmill training, as measured in the laboratory, transfer to improvements in daily life mobility; 3. to understand the mechanisms underlying the transfer from improvements in walking to improvements in mobility in daily life in people with pd; 4. to understand for whom treadmill training improves walking characteristics in the laboratory and for whom it does not, and to understand for whom treadmill training improves mobility in daily life and for whom it does not.


Eligibility criteria:
inclusion criteria: specific criteria for parkinson's disease - pd * diagnosis of parkinson's disease according to the mds world movement disorders society criteria disease severity h\&y i-iii * score section 3.10 (ability to walk) mds-updrs 3.10 ≥ 1 * moca cognitive assessment \> 15 * stable cardiovascular condition, ability to perform aerobic activity at low to moderate intensity * without orthopedic diseases and other diseases that affect the quality of walking, at the decision of the researcher. exclusion criteria: * moderate or severe depression (bdi-ii ≥18) * orthopedic diseases and other diseases that affect the quality of walking, at the decision of the researcher
combined anti-il6r and anticoagulation therapy in advanced npc patients

Conditions: Nasopharyngeal Carcinoma

Summary: the investigators have demonstrated the crucial role of the liver-lung axis in the distant metastasis of npc. furthermore, the investigators have identified a potential therapeutic approach to improve outcomes in npc patients by identifying those most suitable for anticoagulant therapy. further, the combination of anticoagulant therapy and anti-il6r therapy has shown promising results in enhancing the prognosis of npc patients. these findings highlight the significance of targeting the liver-lung axis and utilizing personalized treatment strategies for npc.

distant metastasis accounts for nasopharyngeal carcinoma (npc)-related mortalities. recently, extracellular vesicles (evs) have been widely explored as key mediators of bidirectional tumor-host cell interactions by mediating pre-metastatic niche (pmn) formation. however, considering the complexity of the human body, multiple organ studies of tumor metastasis remain poorly understood. here, the investigators have demonstrated the crucial role of the liver-lung axis in the distant metastasis of npc. the investigators demonstrated mechanistically that hepatocellular derived evs can be specifically taken up by the lung to form a hypercoagulable pre-metastatic microenvironment associated with il6.furthermore, the investigators have identified a potential therapeutic approach to improve outcomes in npc patients by identifying those most suitable for anticoagulant therapy. further, the combination of anticoagulant therapy and anti-il6r therapy has shown promising results in enhancing the prognosis of npc patients. these findings highlight the significance of targeting the liver-lung axis and utilizing personalized treatment strategies for npc.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of npc with distant metastasis * must be able to swallow tablets exclusion criteria: * liver disease * blood disease * long-term use of anticoagulants

Keywords: nasopharyngeal narcinoma metastasis extracellular vesicles organ-organ crosstalk
treatment combination of durvalumab, tremelimumab and enfortumab vedotin or durvalumab and enfortumab vedotin in patients with muscle invasive bladder cancer ineligible to cisplatin or who refuse cisplatin

Conditions: Muscle Invasive Bladder Cancer

Summary: a global phase 3, multicenter, randomized, trial, to determine the efficacy and safety of durvalumab in combination with tremelimumab and enfortumab vedotin or durvalumab in combination with enfortumab vedotin for perioperative treatment in patients ineligible for cisplatin or who refuse cisplantin undergoing radical cystectomy for muscle invasive bladder cancer. the goal of the study is to explore the triplet combination of durvalumab, tremelimumab and enfortumab vedotin or the duplet combination of durvalumab and enfortumab vedotin in terms of efficacy and safety compared to the current standard of care (soc). volga trial consists of two parts: safety run-in and main study. in total the study aims to enroll approximately 677 patients, who will receive triplet combination, duplet combination or currently approved soc in the main trial. in the main part of the trial there is two out of three chances of being on a treatment arm and the treatment is assigned at random by a computer system. in this trial patients in the two treatment arms will receive either 3 cycles of neoadjuvant durvalumab + tremelimumab + enfortumab vedotin or durvalumab + enfortumab vedotin and after surgery both treatment arms will continue with adjuvant durvalumab.

not provided

Eligibility criteria:
inclusion criteria: * histologically or cytologically documented muscle-invasive uc of the bladder. * participants with transitional cell and mixed transitional/non-transitional cell histologies; * participants with mibc clinical tumor (t) stage t2-t4an0/1m0 or uc of the bladder with clinical state t1n1m0 (participants with t1 stage are allowed only with n1 disease) * participants should also have not received prior systemic chemotherapy or immunotherapy for the treatment of mibc or bladder uc. * medically fit for cystectomy and able to receive neoadjuvant therapy; * patients who have not received prior systemic chemotherapy or immunotherapy for treatment of mibc; * ecog performance status of 0,1,2 at enrollment. * availability of tumor sample prior to study entry; * must have a life expectancy of at least 12 weeks at randomization. * cisplatin-ineligible, following criteria based on galsky et al 2011 or refuse cisplatin based chemotherapy (must be documented in the medical records) exclusion criteria: * evidence of lymph node (n2+) or metastatic tcc/uc disease at the time of screening. * active infection * uncontrolled intercurrent illness * prior exposure to immune-mediated therapy (with exclusion of bacillus-calmette guerin \[bcg\]), including but not limited to other anti-ctla-4, anti--pd-1, anti pd-l1, or anti-pd-l2 antibodies. * current or prior use of immunosuppressive medication within 14 days before the first dose of ips.

Keywords: bladder cancer immunotherapy pd-l1 durvalumab (medi4736) tremelimumab enfortumab vedotin (padcev)
bridge the gap (btg) - black youth group

Conditions: Suicide Prevention

Summary: the goal of this clinical trial is to develop and preliminarily test a culturally adapted suicide intervention specifically for black youth. the main question it aims to answer: -to evaluate the feasibility and acceptability of the group, as well as the preliminary efficacy of the group for decreasing suicidal thoughts and behaviors and increasing protective factors such as hope, positive ethnic identity, and family and peer support. participants will be asked to attend 10-week group intervention and complete pre-treatment and post-treatment assessment measures.


Eligibility criteria:
inclusion criteria: * 12-17 years old * identify as black or african american or being of african descent * have current suicidal ideation or suicidal ideation within the last 30 days * have assent from the adolescent participant and consent from an individual's caregiver or guardian to participate. exclusion criteria: * an active psychotic disorder or current psychosis symptoms * no history of suicide attempt(s) or suicide ideation in the past 30 days * cognitive deficits or a medical condition diagnosed from a medical provider that precludes full understanding of study materials as assessed through an inability to complete the pre-treatment cams ssf \& ssp * caregivers, guardians, and/or the patient refuse to participate.

Keywords: suicide prevention black youth collaborative assessment & management of suicidality (cams) group intervention
randomized clinical trial of imagery rescripting treatment in veterans with trauma-related nightmares and posttraumatic stress disorder (ptsd)

Conditions: Stress Disorders, Post-Traumatic; Sleep Disorders

Summary: research shows that symptoms of posttraumatic stress disorder (ptsd) are particularly high in veterans, and that trauma-related nightmares and sleep disturbances are common in veterans with ptsd. this is of concern because people with these problems will often use unhealthy ways of coping. although trauma-related nightmares and difficulty sleeping are highly distressing, there are helpful treatments that do not involve taking medication. one of these treatments teaches specific skills to help people improve their sleep habits and to change their nightmares so that they are less upsetting. this treatment can be very helpful and research shows that people experience decreases in the frequency and severity of their nightmares, decreased symptoms of depression and ptsd, and improved sleep quality and quantity after completing treatment. however, because this treatment has only been studied with civilians, it is not clear how well this treatment works for veterans.


Eligibility criteria:
inclusion criteria: participants will be: 1. patients at the va in the trauma recovery program; 2. english-speaking; 3. reporting at least one posttraumatic nightmare in the past week (due to any type of trauma); 4. have an existing ptsd international classification of diseases, ninth revision, clinical modification (icd-9-cm); and 5. consenting to be randomized into treatment. in addition, patients must agree to allow their assessment and therapy sessions to be video/audiotaped for the purposes of supervision and treatment integrity ratings. participants receiving other forms of group or individual psychotherapy and/or psychotropic medication are eligible for the nightmare treatment condition of the study, provided that those interventions do not specifically target nightmares or ptsd. thus, the study interventions will be in addition to standard care, except as indicated above. exclusion criteria: patients 1. with current active suicidal/homicidal ideation and intent; 2. with current substance dependence; 3. a diagnosis of bipolar or psychosis; 4) prescribed the medication prazosin (a psychotropic medication for the treatment of nightmares). patients in the nightmare treatment condition of the study will also be excluded if they are actively participating in another psychosocial treatment directly addressing their ptsd symptoms. patients will not be excluded if they are taking psychotropic medication (except for prazosin) and may continue to take their medication as prescribed throughout the study.