Kornimate/medical-research-clean huggingface dataset:
study of oral venetoclax tablets to evaluate adverse events and change in disease activity in participants of any age with acute myeloid leukemia

Conditions: Acute Myeloid Leukemia (AML)

Summary: acute myeloid leukemia (aml) is an aggressive and rare cancer of myeloid cells (a white blood cell responsible for fighting infections) and is the most common acute leukemia in adults. this study will assess how safe and effective oral venetoclax is in participants with aml. adverse events and change in disease activity will be monitored under routine clinical practice. venetoclax is an approved drug to treat acute myeloid leukemia (aml). around 400 participants of any age who are treated with oral venetoclax tablets for aml in accordance with the approved label will be enrolled in the study across japan. participants will be followed up to 52 weeks following the first dose of oral venetoclax tablets. there is expected to be no additional burden for participants in this study. data will be collected by information provided by participating physicians based on routine medical records.


Eligibility criteria:
inclusion criteria: - all participants who are administered venetoclax for treatment of aml. exclusion criteria: none

Keywords: acute myeloid leukemia (aml) cancer venetoclax venclexta venclyxto
evaluation of parturients with anxiety

Conditions: Anxiety

Summary: the primary objective of this study is to examine the effects of cognitive bias modification for interpretation (cbm-i) on prenatal anxiety in parturients. half of the participants will receive cbm-i assignments, while the other half will receive placebo assignments.

maternal prenatal anxiety has been shown to have implications on neonatal behavior and early childhood behavioral and emotional wellbeing. recent studies found that adults using computer-assisted feedback-learning paradigms, referred to as cognitive bias modification for interpretation (cbm-i), experienced significant reductions in levels of social anxiety, trait anxiety, and depression. our goal is to identify patients with prenatal anxiety and evaluate the effects of cbm-i on symptoms of prenatal anxiety and patient satisfaction with the labor and delivery experience.

Eligibility criteria:
inclusion criteria: * age 18-45 * women before 36-week gestation * at least high school level education exclusion criteria: * they refuse * have impaired decision-making capacity * are blind or extremely visually impaired (excluding use of glasses) * cannot understand or read english * diagnosed with psychiatric disorder other than anxiety
epidemiologic study of reproductive outcome in women with systemic lupus erythematosus

Conditions: Systemic Lupus Erythematosus

Summary: objectives: i. evaluate whether pregnancy is an independent risk factor that affects disease activity in women with systemic lupus erythematosus. ii. evaluate whether maternal disease activity is a risk factor for adverse pregnancy outcome.

protocol outline: this is a case-controlled study. intensive data collection begins when a patient becomes pregnant. pregnant women are evaluated with interval pregnancy/exposure history and a clinical exam, including the systemic lupus activity measure (slam). assessments are scheduled every 3 months as follows: visit 1 when the pregnancy is confirmed, visit 2 during the second trimester, visit 3 during the third trimester, visit 4 at 3 months postpartum, and visit 5 at 6 months postpartum. visits 4 and 5 include an infant exam for growth and morphologic parameters; these visits occur on the same schedule if there is a miscarriage or stillbirth. patients not currently pregnant are randomly chosen to be followed as controls. these patients undergo a review of current pregnancy status and measures of disease activity, including slam, every 3 months for 5 visits.

Eligibility criteria:
* definite or probable systemic lupus erythematosus meeting american college of rheumatology criteria

Keywords: arthritis & connective tissue diseases immunologic disorders and infectious disorders rare disease systemic lupus erythematosus
the impact of 24/7-phone support on readmission after aortic valve replacement, a randomized clinical trial

Conditions: Aortic Valve Disease

Summary: aortic valve replacement (avr) surgery for aortic valve disease continues to increase in numbers. with better surgical techniques and equipment, also older patients can be operated on, resulting in an growth of the older population. avr is characterized by high rates of hospital readmissions, resulting in suboptimal care planning and higher health care costs. hence, it is important to develop strategies to reduce hospital readmissions following avr. the purpose if this study is to develop and test the efficacy of a 24/7-phone support in the reduction of readmissions after avr treatment. secondary outcomes are a reduced level of anxiety, less depressive symptoms and a better health related quality of life.


Eligibility criteria:
inclusion criteria: * treatment with avr (biological or mechanical) single, avr (b or m)+aortocoronary bypass, avr (b or m)+supra coronary tube graft * can understand, speak and write native language (norwegian), and be able to fill in the questionnaires * can be contacted by phone after discharge from hospital exclusion criteria: * patients who have been admitted to intensive care for more than 24 hours * patients who have complications related to surgery e.g. cerebral insult with significant impact on cognitive functions after surgery

Keywords: telephone support discharge management readmission aortic valve replacement
study watch af detection at home

Conditions: Atrial Fibrillation

Summary: this is a multi-center, prospective, non-randomized study to evaluate the performance of the study watch ppg algorithm in detecting irregular rhythms suggestive of atrial fibrillation (af) in subjects at risk of having an event of af in the free living (home) environment.


Eligibility criteria:
inclusion criteria: * at least 22 years old * able to read and speak english * able and willing to sign written informed consent * interest in participating in the study * at risk of having an af event, as determined by having a diagnosis of paroxysmal af (paf) and meeting one of the following: (a) scheduled or to be scheduled to undergo af ablation, (b) with implantable loop recorder (ilr), implantable cardioverter defibrillator (icd), permanent pacemaker (ppm), holter monitor, or adhesive monitoring patch with documented af burden of ≥25% in the 3 months prior to consent date, (c) cha2ds2vasc ≥3, (d) left atrial diameter ≥4.4 cm * without significant limitation in ability to participate in the study, in the opinion of the investigator exclusion criteria: * currently in a paced rhythm * currently on class ic or class iii antiarrhythmic medication that has been successful in eliminating af (no documented af of more than 30 seconds since the initiation of the medication) * had successful af ablation (no documented af of more than 30 seconds post procedure) * known severe allergy to nickel or metal jewelry * known allergic reaction to adhesives or hydrogels or with family history of adhesive skin allergies * are diagnosed with persistent af * use of implantable neuro-stimulator * open injury or rash where the study device or comparator will be worn
the multicentic trial in fertility-sparing treatment and ovarian preservation management for early endometrial cancer

Conditions: Endometrial Cancer

Summary: through multicenter, prospective, randomized, controlled clinical studies comparing different treatment options (fertility-sparing surgery and ovarian preservation surgery and radical surgery)therapeutic efficacy, safety and quality of life of patients, exploration of the best strategies and risks for the treatment of early endometrial cancer, and promotion and application.

patients eligible for enrollment are selected and divided into three groups randomly, including fertility group,ovarian preservation group and endometrial cancer radical surgery group. take interventions including fertility preservation surgery,ovarian preservation surgery and endometrial cancer radical surgery for patients in different groups respectively. compare therapeutic efficacy, safety and quality of life of patients to evaluate three treatment and explore the best treatment for clinical application.

Eligibility criteria:
inclusion criteria: 1. premenopausal women, age ≤ 50 years 2. surgical curettage / hysteroscopic pathology confirmed, endometrioid adenocarcinoma g1/g2 (including well-differentiated, high-medium and middle-differentiation); 3. clinical consideration of ia (\<1/2 muscle infiltration); 4. first-time treatment 5. the subject (or his legal representative) must understand the nature of the study and sign an informed consent form. exclusion criteria: 1. at the same time participate in other clinical trials; 2. can not tolerate surgery; 3. ovarian suspicious metastasis; 4. have a family history of ovarian cancer; 5. incorporate other malignant tumors; 6. preoperative ca125 abnormal persons

Keywords: preservation of fertility surger ovarian preservation endometrial cancer
rotational atherectomy for calcified lesion by smart angioplasty research team (smart-race)

Conditions: Coronary Artery Disease

Summary: current guidelines recommend the use of rotational atherectomy (ra) for preparation of heavily calcified or severely fibrotic lesions that cannot be crossed by a balloon or adequately dilated before planned stenting (bailout situations). ra emerged in the 1990s as one of several tools to treat luminal obstruction via physical removal of plaque. although initially explored as an alternative to balloon angioplasty, ra has shown favorable acute results in facilitating stent delivery and adequate expansion, particularly those affected by heavy calcification.drug-eluting stents (des) have substantially reduced re-stenosis rates in randomized clinical trials evaluating simple de novo coronary artery lesions and have also shown favorable results when implanted in complex lesions and patients, but higher event rates are observed when treating such subsets compared with simple lesions even with newer generation des. however, there are limited data on evaluating the safety and effectiveness of ra followed by des implantation for heavily calcified lesions in contemporary practice. recent randomized controlled trial shows that ra before paclitaxel eluting stent implantation as first generation des was not superior to paclitaxel eluting stent implantation without prior ra in reducing the primary endpoint of in-stent late luminal loss at 9 months, indicating that ra does not increase the efficacy of des in patients with moderate to severe calcified lesions. however, there were only 15 (12.5%) crossovers from standard therapy to rotablation because of failure of balloon or stent delivery or suboptimal balloon expansion despite the use of a noncompliant balloon. accordingly, procedural and fluoroscopy times were longer in the elective ra and procedural complications occurred equally in both elective ra and bailout ra. these findings might cause by a substantial portion of enrolled population have moderate calcified lesions, but not severe calcified lesions. in particular, everolimus-eluting stent (ees) as newer generation des could act synergistically in heavily calcified lesions as ra could avert stent coating damage and ees could effectively suppress neointimal proliferation. therefore, we compare in-hospital and long-term efficacy or safety of elective ra versus bailout ra and low-volume operator versus high-volume operator in patients with severe calcified lesions treated with ees.


Eligibility criteria:
inclusion criteria: * subject must be at least 19 years of age * angiographically proven coronary artery disease * patients underwent rotational atherectomy * he/she or his/her legally authorized representative provides written informed consent * target lesion(s) must be located in a native coronary artery with visually estimated diameter of ≥ 2.25 mm and ≤ 4.25 mm exclusion criteria: * cardiac arrest before the procedure * pregnancy or breast feeding * thrombotic lesion * saphenous vein graft * unprotected left main lesion
pain outcomes comparing yoga versus structured exercise (poyse) trial

Conditions: Fibromyalgia

Summary: the pain outcomes comparing yoga versus structured exercise (poyse) trial is a 2-arm parallel group, randomized clinical trial to compare the effectiveness of a yoga-based intervention (yoga) with that of a structured exercise program (sep) for subjects with fibromyalgia. the study aims are: 1) to compare the interventions' (yoga vs. sep) effects on overall fibromyalgia severity at 1 month (early response), 3 months (immediate post-intervention) and at 6 and 9 months (sustained effects); 2) to compare the interventions effects on specific fibromyalgia symptoms (pain, sleep, and fatigue), functional impairment, and related outcomes (quality of life, psychological symptoms); and 3) to compare the cost-effectiveness of the interventions.

this study sample will include 306 veterans with fibromyalgia. patients will be randomized to one of two treatment arms. the yoga arm will involve a standardized 12-week, yoga-based intervention. the yoga intervention will consist of three treatment components: 1) in-person group yoga taught by a certified yoga therapist; 2) a relaxation audio recording for home-use; and 3) a dvd recording to reinforce concepts taught during in-person yoga sessions. patients randomized to the structured exercise program (sep) arm will participate in a 12-week exercise program delivered in a group/class format and supervised by a fitness instructor. in addition, sep patients will receive a dvd (for home use) describing the benefits of aerobic exercise for fibromyalgia, a one-on-one consultation session with the fitness instructor, an individualized exercise prescription, and supervised exercise sessions for 12 weeks.

Eligibility criteria:
inclusion criteria: veterans will be eligible if they have: * widespread pain index (wpi) greater than 7 and symptom severity scale (ss) greater than 5 or wpi 3-6 and ss greater than 9. * symptoms have been present at a similar level for at least 3 months * the subject does not have a disorder that would otherwise explain the pain * moderate pain severity (pain severity score greater than 5) * no changes in fibromyalgia medications for last 4 weeks * access to a working telephone exclusion criteria: exclusion criteria includes: * severe medical conditions in which exercise is contraindicated (such as significant cardiovascular disease, copd or asthma needing home oxygen, stroke or tia in last 6 months, cancer (other than skin cancer) and receiving treatment for it * active psychosis * hospitalized for psychiatric reasons within the last 6 months * active suicidal ideation * moderate to severe cognitive impairment * involvement in ongoing yoga classes or moderately intense exercise program in the last 3 months

Keywords: fibromyalgia yoga exercise pain
study of sunitinib with folfiri in colorectal cancer

Conditions: Unresectable or Metastatic Colorectal Cancer

Summary: to evaluate the efficacy, safety and pharmacokinetics of sunitinib plus folfiri (irinotecan, 5-fu and l-leucovorin) in the first-line treatment of japanese mcrc patients


Eligibility criteria:
inclusion criteria: * patient with histologically- or cytologically-confirmed colorectal adenocarcinoma with unresectable or metastatic disease documented on diagnostic imaging studies. * patient must have at least one recist-defined measurable lesion that has not been treated with prior local therapy. exclusion criteria: * history of another primary malignancy within 3 years prior to study entry, with the exception of non-melanoma skin cancer and in situ carcinoma of the uterine cervix. * current, recent, or planned participation in an experimental treatment drug study other than this protocol.
rapid ligating the corresponding inflow and outflow vessels without hilus dissection during hepatectomy

Conditions: Cancer Progression

Summary: this study examines the role of this simple technique on postoperative metastasis and long term survival.

the only hope of long-term survival for patients with primary hepatocellular carcinoma (hcc) is surgical resection or liver transplantation, the former of which is more feasible at present. however, postoperative recurrence or metastasis is an ominous feature for this disease. innovation of the surgical procedure for improving prognosis is under emergency request. this study examines the role of this simple technique on postoperative metastasis and long term survival. during the past 20 years, more 600 patients with primary hcc were performed hepatectomy with the new hemorrhage control technique, and prospective randomized controlled trial (rct) was applied. we further applied a mice model ligating the pedicle of the lesion-located hepatic lobe before hepatectomy to imitate the clinic practice, and evaluated the role of the new technique on postoperative metastasis and survival.

Eligibility criteria:
inclusion criteria: * hcc patients who will perform left- or right- hemihepatectomy. exclusion criteria: 1. contraindication for hepatectomy, including gastrointestinal hemorrhage, severe hemorrhagic disorders, explicit acute nonspecific infectious lesion, overt ascites, child-pugh score c,indocyanine green retention rate at 15min (icgr15)\>30%,serum hepatitis b virus (hbv)-dna\>106 copies/ml and serum alanine aminotransferase (alt)\>2×uln, serum triglycerides\>2.0 mmol/l, circulatory shock, stroke, acute myocardial infarction, renal failure, coma of unknown cause; 2. pregnancy; 3. age of\ 65y

Keywords: hepatocellular carcinoma prognosis
prognosis of isolated left ventricular non-compaction in adults

Conditions: Left Ventricular Non Compaction

Summary: the main objective of this study is to clarify prospectively prognosis of patients newly diagnosed as carriers of a lvnc (incident cases) (i.e. without the occurrence of a survival of the following events: death, heart transplantation or hospitalization for cardiovascular complications). in a second time, prognosis factors will be identify in these patients with lvnc.

isolated left ventricular non compaction (lvnc) is a rare cause of cardiomyopathy supposed to result from the cessation of normal embryogenesis infarction, and characterized by persistent ventricular trabeculations prominent. this is frequently a familial disease, but for which genetic characterization is still incomplete, and then requires the identification of new genes is desirable. the prognosis of lvnc is uncertain, with a mortality rate reported in the literature ranging from 2 to 38%. some series conclude that lvnc is a very severe heart disease, responsible for a high mortality, other that lvnc is frequently associated with a favorable prognosis. these series are however limited by the short duration of follow-up and the small number of patients included. between 2004 and 2006, a french registry lvnc, included 105 cases. it was found out that the lvnc was associated with a high rate of complications such as outbreaks of severe heart failure, need for heart transplantation, severe rhythm disorders, and embolic events. the prognosis of lvnc in france appears as pejorative: 1. - there is no evidence that prognosis is different from other forms of cardiomyopathies. 2. - the results of this register can be skewed by the inclusion of incident and prevalent cases (statistical survival bias). thus, a longer-term monitoring and the identification of relevant prognostic markers are imperative to better understand this rare disease and to improve the therapeutic management.

Eligibility criteria:
inclusion criteria: * male or female aged over 18 years * presenting with left ventricular non compaction (lvnc, group 1) or idiopathic dilated cardiomyopathy (dcm, group 2) * at distance of an acute heart failure thrust (\> 1 month) * newly diagnosed (less than 6 months) * diagnosis confirmed by echocardiography associated or not with a magnetic resonance imaging (mri) confirmed after central review * having signed informed consent form exclusion criteria: * age \<18 years * patients who were diagnosed more than 6 months ago (prevalent cases) * presence of an associated cardiac disease, including valvular, ischemic, or congenital disease * refusal to sign the informed consent form
electronic health mindfulness-based music therapy intervention for patients undergoing allogeneic stem cell transplantation

Conditions: Stem Cell Transplantation; Myelodysplastic Syndromes; Leukemia, Myeloid, Acute; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Lymphoma, Non-Hodgkin

Summary: the goal of this study is to pilot test an electronic health mindfulness-based music therapy intervention (embmt) intervention to improve health-related quality of life (hrqol) and reduce symptom burden of patients undergoing allogeneic stem cell transplantation (allo-sct).


Eligibility criteria:
inclusion criteria: * ≥ 18 years of age * have a primary diagnosis of myelodysplastic syndrome (mds), acute myeloid leukemia (aml), acute lymphoblastic leukemia (all), or non hodgkin's lymphoma (nhl) * have a treatment plan for an allogeneic hematopoietic stem cell transplant * speak english or spanish exclusion criteria: * history of severe psychiatric illness (e.g., psychosis, active suicidality, inpatient treatment in the past 12 months) * severe cognitive impairment (per the short portable mental status questionnaire) * hearing impairment * active alcohol or substance dependence within the past six months * participated in music therapy or mindfulness programs in the past six months