Kornimate/medical-research-clean huggingface dataset:
plasma dosage of venetoclax in the fup of aml patients treated with aza + ven

Conditions: Acute Myeloid Leukemia

Summary: the study proposes to correlate the plasma dosage of ven with the inhibition of its bcl-2 target during the first treatment cycle. ven will be measured sequentially during the first treatment cycle and assess inhibition of its target by measuring the level of phosphorylation of bcl-2 serine 70. in parallel, bh3 profiling will be evaluated sequentially. all these analyses will be correlated with treatment toxicity, response rate and overall patient survival. this pilot study will highlight the inter-individual variability of this aza + ven combination, and enable to launch a national study via the national cooperative groups to validate the results and thus ultimately propose a personalized treatment for patients benefiting from this combination.


Eligibility criteria:
inclusion criteria : * patient with acute myeloid leukemia (aml) not eligible for intensive chemotherapy * patients aged 18 or over * patient treated with the combination azacitidine (aza) + venetoclax (ven) * patient having signed the study informed consent form * patient with social security coverage exclusion criteria : * patients receiving treatment inhibiting or inducing cytochrome cyp3a4 * presence of an active, uncontrolled infection * patient participating or having participated in a clinical drug trial in the month prior to inclusion. * vulnerable persons

Keywords: acute myeloid leukemia venetoclax azacitidine
distraction and vibration for minimizing pain during childhood vaccination

Conditions: Pain Due to Childhood Vaccination

Summary: vaccine pain control is one of the actions suggested to support the delivery of vaccines that are on a vaccine schedule, since pain and anxiety associated with vaccines are among the main reasons why children and their parents fail to do them properly. thus, it is very important to investigate which interventions can bring greater benefit in the control of pain.this is a randomized clinical trial aiming to assess the impact of video distraction and vibration device on pain during the vaccination of children between one and three years.


Eligibility criteria:
inclusion criteria: * children between 1 year and 3 years, 11 months and 29 days of life. * be accompanied by legal guardian. * apply only one injectable vaccine at the time of the research. exclusion criteria: * refuses to sign the consent form. * have already been included in the study previously.
comparative effectiveness of ultrasound and paraffin therapy in patients with carpal tunnel syndrome: a randomized trial

Conditions: Carpal Tunnel Syndrome

Summary: the purpose of this study is to compare the efficacy of combining a wrist orthosis with either ultrasound therapy or paraffin bath therapy in treating carpal tunnel syndrome patients.

the purpose of this exploratory study is to compare the combination of a wrist orthosis with either ultrasound therapy or paraffin bath therapy in the treatment of carpal tunnel syndrome patients. we hypothesized that ultrasound therapy might be more effective than paraffin therapy because it provides both thermal and nonthermal effects.

Eligibility criteria:
inclusion criteria: * patients to have subjective symptoms (such as pain and/or numbness in the median nerve distribution of the digits or nocturnal pain). furthermore, patients were required to have either a positive phalen's sign or a positive tinel's sign along with electrophysiological evidence of carpal tunnel syndrome. exclusion criteria: * (1) age younger than 18 years old; (2) underlying medical disorders, such as diabetes mellitus, renal failure, autoimmune disease or hypothyroidism; and (3) pregnancy, previous wrist trauma or surgery.
effect of carbloading and maltodextrin on the level of function in patients with apoplexia

Conditions: Apoplexy; Brain

Summary: the study will investigate the potential effect of a supplement of maltodextrin and added dietary carbohydrates on the level of function in patients with apoplexia. the study has an intervention group and a control group. the study is randomized, but not blinded. the primary outcome is level of function measured with barthel-100. besides the primary outcome there are several secondary outcomes (see detailed description). all patients are recruited from rigshospitalet, glostrup.

the study will investigate the potential effect of a supplement of maltodextrin (20 g for women and 30 g for men) and added dietary carbohydrates on the level of function in patients with apoplexia. the study has an intervention group and a control group. the study is randomized, but not blinded. the primary outcome is level of function measured with barthel-100. secondary outcomes are: training intensity, duration and frequency; length of stay; self-training (training without a therapist) and patient's experienced fatigue; and patient's experienced pain. all patients are recruited from rigshospitalet, glostrup. the supplement will be administered before and after each training session with a therapist. the supplement is a powder desolved in a glass of juice. the nursing staff will add extra carbohydrates to the patient's meals in the form of potatoes, rice, bread, fruit or other carbohydrate rich food items. all meals will be noted daily and validated the following day by the primary investigators.

Eligibility criteria:
inclusion criteria: * patients with apoplexia who are declared suited for rehabilitation at afs. neurologisk afdeling n 35 - apopleksi or afs. neurologisk afdeling n 45 - apopleksi, rigshospitalet, glostrup * patient must be able to consent participation * age 50+ years * must be able to understand danish * must be relevant for physio- or occupational therapy exclusion criteria: * diabetes mellitus type i og type ii * enteral nutrition (tube feeding) * barthel-100 over 80 points

Keywords: carbohydrates rehabilitation high-carbohydrate diet
effect of short-term oxygen during cpet in copd

Conditions: Chronic Obstructive Pulmonary Disease

Summary: in a randomized, sham-controlled trial the investigators will test whether supplemental oxygen given during cardiopulmonary exercise testing will improve exercise performance and physiological parameters in patients with chronic obstructive pulmonary disease.


Eligibility criteria:
inclusion criteria: * diagnosis of chronic obstructive pulmonary disease * on optimized medical therapy and in stable condition for at least 4 week * desaturate in the 6 minute walking test by at least 4% to values \<92% exclusion criteria: * unstable conditions * pregnant women * patients with relevant concomitant lung disease and severe daytime hypoxemia
rituximab in treating patients with waldenstrom's macroglobulinemia

Conditions: Lymphoma

Summary: rationale: monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. purpose: phase ii trial to study the effectiveness of rituximab in treating patients who have waldenstrom's macroglobulinemia.

objectives: i. determine the objective response, time to treatment failure, and toxicity in patients with waldenstrom's macroglobulinemia treated with rituximab. ii. correlate expression and changes in expression of cd20 on patient plasma cells and b-cells with clinical responses. outline: this is a multicenter study. patients receive rituximab iv weekly for 4 weeks. treatment may be repeated 2 months later in patients with stable disease, partial response, or complete response. patients are followed every 6 months for 2 years. projected accrual: a total of 12-25 patients will be accrued for this study.

Eligibility criteria:
inclusion criteria: * waldenstrom's macroglobulinemia requiring therapy who have received no more than 2 prior courses of therapy; previously untreated patients with slowly progressive wm if the patient can reasonably be expected to not require chemotherapy or steroid therapy for 90 days * cd20 positive tumor cells * presence of monoclonal paraprotein * minimum igm level \> 2 times the upper limit of normal * adequate organ function: anc\>1000/ul; plt \> 25000/ul; serum creatinine \< 2.5; serum total bilirubin and sgot \< 2.5 times the upper limit of normal * 18 years and older * life expectancy of 6 months or greater * ecog performance status of 0-2 * men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for 6 months after completion of treatment exclusion criteria: * chemotherapy, steroid therapy, or radiation therapy within 30 days of study entry * patients who are pregnant * serious co-morbid disease * uncontrolled bacterial, fungal, or viral infection * active second malignancy * individuals who cannot provide informed written consent

Keywords: waldenstrom macroglobulinemia
effects of sitagliptin in individuals with genetically decreased dpp4

Conditions: Genetics Disease; Type2 Diabetes; Heart Failure

Summary: this is a pilot clinical trial to test the hypothesis that during sitagliptin (dpp4 inhibitor), individuals heterozygous for dpp4 loss of function variants will have a reduction in dpp4 activity and antigen, lower glucose after a mixed meal, and higher levels of intact dpp4 substrates compared to during placebo and compared to matched controls.

participants of this pilot clinical trial will be randomized in a blinded 2:2 crossover manner to receive placebo and sitagliptin 100 mg/d (dpp4 inhibitor), in random order. subjects will receive each intervention for seven days, with a study day on day 7. each intervention will be separated by a 4-week washout period. each subject will have up to four separate visits: 1) dxa, echocardiogram, 2) cardiac mri, 3) mixed meal during placebo, 4) mixed meal during sitagliptin. the study will include 10 cases and 10 controls. among these, there will be five heterozygous cases and five matched controls with elevated blood pressure (history of blood pressure 130/80 on more than one occasion or prior diagnosis of hypertension by a medical provider) and five cases and five controls without hypertension.

Eligibility criteria:
inclusion criteria: * participant of the penn medicine biobank who is willing to be recontacted to participate in future research. * cases are defined as adults 18-70 years with likely decreased dpp4. * controls are defined as adults who are matched to cases by: age, gender, race, bmi, hypertension status, diabetes status, renal function, and medication use that may affect outcomes of interest. exclusion criteria: * the study will exclude volunteers with any significant medical conditions that may interfere with study participation, data interpretation, or pose safety risk(s) to the subject. * recent hospitalization or acute illness such as infection within the past two weeks * pregnancy * use of insulin * use of a glp-1 agonist or dpp4 inhibitor medication * use of oral diabetes agents other than metformin unless matched with controls * type 1 diabetes * chronic steroid use or use within the last 30 days * significant liver disease including liver enzymes \>3 x upper limit of normal range * renal dysfunction defined as egfr\< 50ml/min/1.73m2 * significant cardiac disease such as heart transplantation * significant gastrointestinal conditions that may interfere with drug absorption or glp-1 release including bariatric surgery * significant hematologic disease such as hematocrit \<35% * use of chronic anticoagulation * severe pulmonary disease * severe neurologic or psychiatric disease * inability to comprehend study procedures

Keywords: genetics sitagliptin dpp4 inhibition heart failure type 2 diabetes
phase ib/ii study of hrs2398 in combination with adebrelimab in patients with advanced solid tumors

Conditions: Advanced Solid Tumors

Summary: this study is a multicenter, open-label, dose-finding/efficacy-expanding phase ib/ii clinical trial, which aims to observe and evaluate the tolerability, safety, pharmacokinetic characteristics and immunogenicity of hrs2398 combined with adebrelimab injection in patients with advanced solid tumors, determine the rp2d, and preliminarily evaluate the efficacy of hrs2398 combined with adebrelimab in patients with advanced solid tumors.


Eligibility criteria:
inclusion criteria: 1. subjects are able to give voluntary informed consent, understand the study and are willing to follow and complete all the test procedures. 2. age 18\~75 years old. 3. dose escalation phase: patients with clinically diagnosed or pathologically confirmed advanced solid tumors who have failed standard therapy (disease progression during or after treatment) or for whom no effective standard treatment regimen exists. 4. dose expansion and efficacy expansion phase: patients with advanced solid tumors who have received systemic immunotherapy and platinum-containing chemotherapy in the recurrent/metastatic settings. 5. at least one measurable lesion per recist v1.1 criteria. 6. ecog ps score: 0-1. exclusion criteria: 1. patients with meningeal metastases; or with brain metastases that have not been treated with surgery or radiotherapy. 2. cancerous ascites and pleural effusion with clinical symptoms, requiring puncture and drainage; or those who have received ascites, pleural effusion drainage within 14 days before the first dose. 3. presence of any active, known autoimmune disease.
a study to evaluate white matter hyperintensities in migraine

Conditions: Migraine; Small Vessel Ischemic Disease; Multiple Sclerosis

Summary: the purpose of this research is to better understand brain white matter hyperintensities (wmh) in women with migraines


Eligibility criteria:
inclusion criteria - migraine (n=20): * female only. * ages 20-45 years. * presence of wmh on mri. exclusion criteria: * history of svi and/or history of ms or other neurological disease other than migraine. * history of cancer or organ transplantation. * contraindication to mri. * pregnancy. * history of abnormal brain mri other than wmh. * subjects not willing to comply with the study procedures will be removed from the study. inclusion criteria - svi disease (n=10): * female only * ages \> 60 years. * presence of wmh on mri. exclusion criteria: * history of migraine and/or history of ms or other neurological disease other than svi. * history of cancer or organ transplantation. * history of abnormal brain mri other than wmh. * pregnancy. * history of abnormal brain mri other than wmh. * subjects not willing to comply with the study procedures will be removed from the study. inclusion criteria - ms (n=10): * female only. * ages 20-45. * presence of wmh on mri. exclusion criteria: * history of migraine and/or history of svi or other neurological disease other than ms. * history of cancer or organ transplantation. * history of abnormal brain mri other than wmh. * pregnancy. * history of abnormal brain mri other than wmh. * subjects not willing to comply with the study procedures will be removed from the study.
pigtail catheter versus chest tube in the management of traumatic pneumothorax

Conditions: Traumatic Pneumothorax

Summary: a small 14-french(f) pigtail catheter (pc) has been shown to work equally well with traditional 32-40f chest tube (ct), especially in traumatic pneumothorax. there are no clinical data on tube-site pain. the investigators hypothesize that pc tube site pain is less than ct.

primary outcome: - tube site pain * pain medication requirement secondary outcome: failure rate insertion-related complication

Eligibility criteria:
inclusion criteria: * 18 years old and above * suffer traumatic pneumothorax that requires chest tube insertion exclusion criteria: * emergency chest tube insertion * patient refuses * patient is unable to provide or rate pain assessment * prisoner * pregnancy * patient with gcs less than 13

Keywords: trauma pneumothorax
well-being in ibs: strengths and happiness (wish)

Conditions: Irritable Bowel Syndrome

Summary: the purpose of this pilot study is to examine the feasibility, acceptability, and preliminary efficacy of a customized positive psychology (pp) intervention for patients with irritable bowel syndrome (ibs) compared to a wait list control group.

irritable bowel syndrome (ibs), a disorder of gut-brain interaction (dgbi; formerly known as functional gastrointestinal disorder) is characterized by abdominal pain and altered bowel habits, and conceptualized as resulting from complex interactions between biological, psychological, and social factors. the treatment approach for ibs is multifaceted and focused on symptom reduction rather than cure. for mild or infrequent symptoms, lifestyle modification (e.g., diet and exercise), reassurance, and education about the disorder can at times be sufficient. for moderate to severe symptoms, a combination of pharmacotherapy and behavioral health interventions is often required. a growing body of evidence supports the use of behavioral health interventions to target the gut-brain axis in dgbi - aptly referred to as brain-gut behavior therapies (bgbt). though highly effective, existing bgbt for ibs face important limitations including scalability and acceptability. there is also limited focus among existing bgbt on the promotion of positive psychological (pp) constructs (e.g., optimism), which are deficient in ibs, associated with fewer ibs symptoms, and associated with lower levels of distress in both clinical and non-clinical populations. pp interventions have successfully been implemented in a variety of other chronic medical conditions to improve well-being, health-related quality of life, and health behavior engagement. pp interventions are highly acceptable and easily delivered remotely without extensive specialized training, which increases their scalability and reach. as such, the investigators plan to do the following in this project: 1. examine the feasibility and acceptability of a 9-week, telephone-delivered pp intervention adapted to the ibs population 2. explore the impact of the pp intervention on psychological, behavioral, and health-related outcomes, compared to a wait list control group.

Eligibility criteria:
inclusion criteria: * ibs diagnosis: adult patients with an ibs diagnosis documented by the patient's primary care or gi clinician and meeting standardized rome iv diagnostic criteria. * language and communication: english fluency and access to a telephone. exclusion criteria: * severe psychiatric illness: current manic episode, psychosis, or active substance use disorder diagnosed via the mini international neuropsychiatric interview (mini). * cognitive impairment: assessed using a six-item cognitive screen developed for research.
the safety of anesthesia management for traumatic hip surgery in elderly

Conditions: Hip Fractures

Summary: trauma for hip joint is common in old people. anesthesia in these types of old patients carries more risk than the adult population. in this study the investigators will review patient's records that underwent surgery for hip trauma under anesthesia, and to see if type of anesthesia affects patient's outcome and the rate of postoperative complications.

trauma for hip joint is common in old people; usually trauma for the hip joint is treated surgically under anesthesia. anesthesia in these types of old patients carries more risk than the adult population, since these type of patients have a lot of chronic diseases which affect their general health. in this study the investigators will review patient's records that underwent surgery for hip trauma under anesthesia between the years 2010 to 2015, and to see if type of anesthesia affects patient's outcome and the rate of postoperative complications like deep venous thrombosis, pulmonary complications, myocardial infarction and others.

Eligibility criteria:
inclusion criteria: * patients who sustained hip fracture. * patients who underwent surgical correction under regional or general anesthesia. exclusion criteria: * patients who sustained hip fractures but treated conservatively.
process-based therapy for difficult-to-treat anxiety disorders and depression

Conditions: Depression; Anxiety Disorder

Summary: the aim of this study is to test the relative efficacy of process-based therapy compared to traditional cbt delivered in routine practice (r-cbt) for difficult-to-treat anxiety disorders and depression.

process-based therapy (pbt) is a new framework to intervention planning, based on the use of ecological momentary assessment (ema) data, feedback of dynamic network analysis and matching of interventions to central nodes of the network. although preliminary support for its applicability has been reported from a single-case study, there are no data on the feasibility and effectiveness in a larger clinical sample. the investigators have translated a training manual of pbt and modified for delivery of cbt in mental health service. the aim of this study is to test the relative efficacy of pbt compared to traditional cbt delivered in routine practice (r-cbt) for difficult-to-treat anxiety disorders and depression.

Eligibility criteria:
inclusion criteria: * a primary dsm-5 diagnosis of depressive or anxiety disorder * at least two unsuccessful attempts of pharmacological or psychological treatment according to the german guidelines for the treatment of depression or anxiety disorders (arbeitsgemeinschaft der wissenschaftlichen medizinischen fachgesellschaften, awmf) * age 18-65 years * sufficient knowledge of the german language * participating patients are not required to discontinue medication, but to keep medication constant over the treatment period exclusion criteria: * increased suicidality * substance abuse or dependency * borderline personality disorder * pervasive developmental disorder * psychotic disorder * eating disorder * bipolar disorder * severe physical illness
unidos contra el vph

Conditions: Human Papilloma Virus (HPV); Cervical Cancers

Summary: the purpose of the unidos contra el vph study is to help find options to screen, or check, for cervical cancer that individuals can do at home to help prevent and detect cervical cancer early. usually, people get screened for cervical cancer with a pap smear and human papillomavirus (hpv) test by a health care provider. this is not always easy for individuals who are not able to get to a clinic or feel uncomfortable having the procedure done. that is why we want to find other ways that may be easier and more comfortable for people to be screened for cervical cancer. the two main questions the study aims to answer are: 1. how do the following three cervical cancer screening methods compare for improving screening completion rates? o in-home hpv self-sampling with a vaginal swab * in-home hpv self-sampling with urine testing * in-clinic traditional pap smear with hpv test 2. what are participant beliefs and preferences regarding these three screening methods? participants in the study will be randomly assigned to one of three groups. this means each person has an equal chance of being placed in any group. they will also complete two surveys as part of the study. the three screening method groups are described below: group 1: urine self-sampling * participants in this group will receive a kit with a urine sample cup to use at home, instructions explaining how to take the sample and a pre-paid mailing box to mail the urine sample to the lab. group 2: vaginal swab self-sampling o participants in this group will receive a kit with a vaginal swab and collection tube to use at home, instructions explaining how to take the sample and a pre-paid mailing box to mail the sample to the lab. group 3: in-clinic screening * an in-clinic co-testing appointment is scheduled for a pap smear and hpv test done together at project vida health center. by comparing these approaches, this study aims to improve access to cervical cancer screening and provide better options for those who face barriers to clinic-based screening.


Eligibility criteria:
inclusion criteria: * individuals with a cervix who are 30-65 years and have not undergone a pap test in at least three years. exclusion criteria: * having had a hysterectomy or a personal history of cervical cancer.