Kornimate/medical-research-clean huggingface dataset:
efficacy & safety study of kpt-330 in erythropoietin-refractory lower-risk myelodysplastic syndrome patients

Conditions: Myelodysplastic Syndrome

Summary: this is an open-label study designed to evaluate the safety and efficacy of the selective inhibitor of nuclear export (sine) compound, selinexor given orally to patients with transfusion-dependent, epo-refractory lower-risk mds (low risk and intermediate-1 as defined by ipss).

this is a single-arm, open-label, study designed to evaluate the safety and efficacy of the selective inhibitor of nuclear export (sine) compound, selinexor given orally to patients with transfusion-dependent, epo-refractory lower-risk mds (low risk and intermediate-1 as defined by ipss). patients will be dosed at the clinic on clinic visit days and received selinexor for dosing at home on additional days. patients will be evaluated for disease response according to the 2006 iwg response criteria for mds. this includes evaluation for altering the natural history of disease, cytogenic response hematologic improvement, and quality of life.

Eligibility criteria:
inclusion criteria: * diagnosis of low risk or intermediate-1 risk mds with any cytogenetic abnormalities (according to the ipss criteria); patients must have bone marrow biopsy/aspiration or tumor tissue available from within 1 month prior to first dose or collected during the screening period. * patients \>18 years at screening who are not candidates for hematopoietic cell transplantation. * received 1 prior line of treatment; typically erythroid-stimulating agents (esas). * red blood cell (rbc) transfusion-dependent anemia while treated with or after discontinuation of epo. transfusion dependence is defined as the requirement for at least 2 units of rbcs transfused during the 8 weeks prior to study initiation. exclusion criteria: * use of recombinant epo within 8 weeks prior to screening. * patient has a concurrent active malignancy or prior history of malignancy other than mds (except basal cell or squamous cell carcinoma of the skin and in situ of the cervix) unless free of disease for at least 1 year. * unstable cardiovascular function: * symptomatic ischemia, * uncontrolled clinically significant conduction abnormalities (i.e., ventricular tachycardia on anti-arrhythmic agents are excluded; 1st degree atrioventricular (av) block or asymptomatic left anterior fascicular block/right bundle branch block (lafb/rbbb) will not be excluded), or * congestive heart failure (chf) new york heart association (nyha) class ≥3, or myocardial infarction (mi) within 3 months. * uncontrolled infection requiring parenteral antibiotics, antivirals, or antifungals within 1 week prior to first dose. infections controlled on concurrent anti-microbial agents are acceptable, and anti-microbial prophylaxis per institutional guidelines is acceptable. * active bleeding grade 3-4, in the last 4 weeks prior to enrollment.

Keywords: kpt-330 karyopharm selinexor sier myelodysplastic syndrome (mds) erythropoietin (epo) refractory
zalutumumab in combination with chemo-radiation in a certain type of lung cancer

Conditions: Non Small Cell Lung Cancer

Summary: the purpose of the study is to investigate if treatment with zalutumumab in combination with chemotherapy and radiotherapy (chemo-radiation) will lead to a prolonged life in patients with lung cancer compared to patients treated with chemo-radiation alone.

originally the study was planned as part 1a, part 1b and part 2. part 1a was one arm with zalatumumab fixed dose 8 mg/kg. part 1b was planned as zalutumumab dose-titration and part 2 adding a comparator. the trial was prematurely closed for enrolment when patients had only been enrolled in part 1a due to published results showing increased toxicity from induction chemotherapy without any survival benefit.

Eligibility criteria:
inclusion criteria: * nsclc stage iiia-iiib * performance status 0 or 1 (zubrod or who scale) exclusion criteria: * evidence of metastases either in a separate lobe of the lung, or extra thoracic * patients with high risk of radiation pneumonitis and or compromised lung function * estimated life expectancy of less than 3 months * prior chemotherapy for lung cancer * prior radiotherapy to the chest * prior surgery with curative intent for lung cancer
clareon panoptix pro vs. clareon panoptix - study b

Conditions: Aphakia; Presbyopia

Summary: the purpose of this study is to evaluate the safety and effectiveness of clareon™ panoptix™ pro trifocal intraocular lens (iol) compared to clareon™ panoptix™ trifocal iol.

subjects will attend 9 scheduled study visits for a total individual duration of participation of approximately 7 months. the primary endpoint will be assessed at the month 2 follow-up visit. both eyes of a subject must qualify for enrollment into this study.

Eligibility criteria:
key inclusion criteria: * understand and sign an ethics committee-approved informed consent form; * willing and able to attend all scheduled study visits as required by the protocol; * planned cataract surgery (both eyes); * preoperative corneal astigmatism less that 1.00 diopter in each eye. * other protocol-defined inclusion criteria may apply. key exclusion criteria: * women of childbearing potential if currently pregnant, intend to become pregnant during the study, or are breastfeeding; * ocular conditions as specified in the protocol; * subjects who desire monovision correction. * other protocol-defined exclusion criteria may apply.

Keywords: cataract iol
study of tissue and blood samples from patients with recurrent prostate cancer who received lapatinib on clinical trial ecog-e5803

Conditions: Prostate Cancer

Summary: rationale: studying samples of tumor tissue and blood in the laboratory from patients with cancer may help doctors learn more about changes that occur in dna and identify biomarkers related to cancer. it may also help doctors predict how patients will respond to treatment. purpose: this research study is looking at tissue and blood samples from patients with recurrent prostate cancer who received lapatinib on clinical trial ecog-e5803.

objectives: * to determine the association between polymorphisms in drug metabolizing enzymes and lapatinib ditosylate-associated toxicity in patients with hormone-sensitive recurrent prostate cancer receiving lapatinib ditosylate on clinical trial ecog-e5803. * to determine the association between mutations in egfr, her-2 and kras; protein expression of her2, egfr, mapk and akt; polymorphism controlling androgen synthesis; and progression-free survival. outline: tissue and blood samples collected from patients enrolled on clinical trial ecog-e5803 are analyzed for correlative studies. samples are assessed for her2, egfr, mapk, and akt; egfr mutations and polymorphisms in cyp3a4; ras mutations; recently identified mutations in her2-neu and kras; and additional polymorphisms in the lapatinib ditosylate metabolic pathway by automated quantitative ihc. predictors of efficacy and toxicity are analyzed, including markers in the egfr pathway as predictors of progression-free survival.

Eligibility criteria:
disease characteristics: * diagnosis of prostate cancer * recurrent disease * received lapatinib ditosylate on clinical trial ecog-e5803 patient characteristics: * not specified prior concurrent therapy: * see disease characteristics

Keywords: recurrent prostate cancer
use and safety of the lutonix® drug coated balloon catheter in arteries of the lower extremity

Conditions: Peripheral Artery Disease

Summary: the registry will enroll patients with claudication or critical limb ischemia and angiographically significant lesion(s) in arteries of the lower extremity. subjects will be treated with the lutonix® drug coated balloon catheter for approved indications according to the current country-specific instructions for use (ifu) and followed clinically for 1 year.

this post-market registry is intended to assess the clinical use and safety of the lutonix® drug coated balloon catheter in a heterogeneous patient population in real world clinical practice. up to 500 patients will be enrolled in order to allow identification and assessment of rare adverse events (aes) as well as outcomes in subpopulations defined by subject and lesion characteristics. all subjects will be followed for 1 year. this registry is performed with marketed devices within the indications for use. there are no additional treatments or exams that will take place within this registry.

Eligibility criteria:
inclusion criteria: 1. ≥ 18 years of age; 2. rutherford clinical category ≤ 5; 3. patient or legally authorized representative is willing to provide informed consent and comply with the required follow up; 4. stenotic or obstructive vascular lesions in artery(s) of the lower extremity; 5. lesion(s) can be treated with available lutonix drug coated balloon catheter device size matrix per current country-specific ifu. exclusion criteria: 1. patient is currently participating in an active phase of another investigational drug or device study; 2. inability to take recommended medications as stated in the ifu or non-controllable allergy to contrast.
well being and resilience: mechanisms of transmission of health and risk

Conditions: Psychotic Disorder; Bipolar Disorder; Depressive Disorder

Summary: the purpose of this study is to establish a cohort of pregnant women with severe mental disorder and to identify biological and psycho-social transmission mechanisms involved in the development of 'risk' and 'resilience' in the offspring. it is assumed that both 'resilient' and 'risk' development in offspring are caused by a complex interaction between multiple biological, psychological and social factors. the project focuses specifically on exploring the impact of physiological stress-sensitivity, attachment, care-giving and the familial and social context for care-giving. previous studies support these factors as important for the development of these infants, but systematic research using a prospective design is needed to strengthen evidence and elucidate the importance of these factors in more detail. the interaction over time of physiological stress-sensitivity, attachment, care-giving and the familial and social context for care-giving are evaluated in terms of the evolution of very early indicators of developmental risk and resilience in infants with a known highly increased risk for developing a mental disorder.the findings of the study may potentially lead to more specific targets for preventive interventions, which can improve developmental outcome for these infants.


Eligibility criteria:
inclusion criteria: * pregnant women with psychotic disorder (dsm-5: delusional disorder (297.1) * schizophreniform disorder (295.4), schizophrenia (295.90), schizoaffective disorder (295.70) * brief psychotic disorder (298.8) other specified schizophrenia spectrum and other psychotic disorder (298.8), unspecified schizophrenia spectrum and other psychotic disorder (298.9) ) * lifetime diagnosis of dsm-5 bipolar i and ii disorder (296.89) * diagnosis of dsm-5 major depressive disorder current single episode (current 296.22 - 296.25) or recurrent episode (296.32 - 296.35) * non-psychiatric control group defined as mothers without any history of treatment or admission for a psychiatric disorder or drug or alcohol addiction. * partners of participating women with an expected care-giving role in relation to the infant will also be eligible for participation in the study. * infants of participating pregnant women will be included from birth. exclusion criteria: * unable to provide informed consent to participate * unable to speak english or danish because of the requirement to complete assessments, * miscarriage.

Keywords: offspring attachment risk development resilience
effectiveness of percutaneous neuromodulation in the treatment of cervical pain in university students.

Conditions: Neck Pain

Summary: a non-randomized experimental study will be conducted to investigate the effect of ecoguided percutaneous neuromodulation on patients with and without neck pain in college students. the sample will be collected in a non-probabilistic way at convenience among the students at the san pablo-ceu university, with a sample that will be divided into two groups: group 1 (g1) with neck pain and group 2 (g2).


Eligibility criteria:
inclusion criteria: * current cervical pain on a visual analog scale (vas) greater than 3. * neck pain in the last 12 weeks, and no treatment has been performed. * disability index of 8% or more on the neck disability index. * that they have undergone treatment. exclusion criteria: * neck pain associated with vertigo. * osteoporosis (control x-ray). * diagnosed psychological disorders. * vertebral fractures (control x-ray). * tumors. * diagnosed metabolic diseases. * neck surgery. * belonephobia.

Keywords: pain ecoguided percutaneous neuromodulation
bupropion for the treatment of methamphetamine dependence - 1

Conditions: Amphetamine-Related Disorders

Summary: the purpose of this study is to assess the efficacy and safety of bupropion in reducing methamphetamine use in subjects with methamphetamine dependence

a double-blind, placebo-controlled, parallel-group design study in which 100 subjects will be randomly assigned to placebo or bupropion for 12 weeks with follow-up assessments 4 weeks following treatment. adaptive randomization will be used to balance treatment groups based on gender.

Eligibility criteria:
inclusion criteria: * subject must have methamphetamine dependence as determined by the dsm-iv diagnosis * subject must be willing to comply with study procedures. * ability to verbalize understanding of consent form, provide written consent, and verbalize willingness to complete study procedures * be able to comply with protocol requirements exclusion criteria: * please contact site for more information.

Keywords: amphetamine dependence
italian study on the right hemicolectomy: how the lymphadenectomy is performed

Conditions: Colon Cancer; Lymph Node Metastasis; Surgical Procedure, Unspecified

Summary: the objective of the study is the analysis of lymphadenectomy in the course of right hemicolectomy, in relation to the radicality of the surgical resection that is performed. in particular, the investigators wants to inquire how according to precise standards regarding surgical radicalness and consequently the anatomical piece that is obtained it is possible to correlate a certain number of lymph nodes and their possible positivity. the lead center is the general and thoracic surgery department of the university of ferrara. prof. anania is the responsible for the enrollment of patients and the coordination with the collaborating centers in the six month-study

all the high-volume specialist centres that perform this type of intervention in italy will be invited, with a minimum number of 25 interventions per year. at the end of the study 788 patients was enrolled. the data of the patients involved will be collected independently and anonymously by the individual centers involved, using a common alpha numeric code decided by the coordinating center. the parameters examined will be: * personal data of the patient * stage of neoplasm due to surgery * type of surgery and duration * post-operative course * presence of post-surgical complications and eventual hospital readmission due to these complications * study of the operating piece and lymphadenectomy performed: tumor free margin terminal ilium length the different vascular ligatures and levels at which they are performed integrity of the mesocolon number of positive nodes per total removed following the end of the 6 months of observational study period, the data will be processed anonymously at the coordinating centre.

Eligibility criteria:
inclusion criteria: * patients and/or legal guardians, where applicable, have been fully informed and have voluntarily provided informed written consent or patients unable to read and/or write who have fully understood the information verbally provided by the investigator and who have provided a verbal consent testified in writing by a third person. * patients aged \> 18, men and women, operated by laparoscopic right hemiolectomy or video assisted, under election regime at the u.o. general and thoracic surgery with diagnosis of colic adenocarcinoma at any stage. * patients who have already undergone chemotherapy and radiotherapy for other reasons. exclusion criteria: * under age. * patients undergoing emergency surgery. * women who are pregnant. * patients with right-handed laparotomy

Keywords: right hemicolectomy colon cancer lymphadenectomy
tocotrienol in combination with neoadjuvant chemotherapy for women with breast cancer

Conditions: Breast Cancer

Summary: the purpose of this study is to investigate whether tocotrienol can improve the effect and reduce the side effects of standard chemotherapy before operation for breast cancer.


Eligibility criteria:
inclusion criteria: * women with histologically verified breast cancer (adenocarcinoma) * age ≥ 18 years. * neoadjuvant treatment indicated according to departmental guidelines * ps 0-2 and suited for surgery. * normal heart function, lvef ≥ 50% by muga/echo in patients receiving neoadjuvant trastuzumab * normal bone marrow function: hemoglobin ≥ 6 mmol/l; anc ≥ 1.5x10\^9/l; thrombocytes ≥ 100x10\^9/l. * normal liver function: bilirubin ≤ 1.5 x upper level of normal, alat ≤ 2.5 x upper level of normal, basp ≤ 2.5 x upper level of normal. * normal kidney function: creatinine ≤ upper level of normal. in case of increased creatinine, measured/calculated gfr must be ≥ 50 ml/min. * fertile women must present a negative pregnancy test and use a safe contraceptive during and 3 months after the treatment. intrauterine device without hormone is considered safe. * written and orally informed consent exclusion criteria: * bilateral breast cancer or suspected dissemination. verified by bilateral mammography, bone scintigraphy, chest and abdomen ct, and pet-ct. * pregnant and breastfeeding women * mental or social conditions that will prevent treatment or follow-up * other simultaneous experimental treatment * immunosuppressive treatment (other than prednisolone during neoadjuvant chemotherapy) * vitamin or nutritional supplements (other than multivitamin tablet and calcium tablet with vitamin d) * active or latent viral/bacterial infection * rheumatoid arthritis or other autoimmune disease * other malignant disease within the past 5 years excl. non-melanoma cancer of the skin and carcinoma in situ cervicis uteri. * previous treatment with docetaxel, paclitaxel, epirubicin, cyclophosphamide, trastuzumab, pertuzumab or tocotrienol * hypersensitivity to any of the active or auxiliary substances
evaluation of the effect of pulmonary rehabilitation on patients with high flow oxygen therapy

Conditions: Pulmonary Disease

Summary: evaluation of the effect of pulmonary rehabilitation on patients with high flow oxygen therapy

objective: the purpose of this study was to evaluate the effect of lung rehabilitation on patients treated with high flow humidification apparatus in icu. methods: 70 patients in icu who were treated with high flow humidification apparatus from june 2019 to june 2020 were randomly divided into two groups. the experimental group was treated with pulmonary rehabilitation and the control group was treated with routine medical treatment only. all patients were evaluated and measured by bedside diaphragm ultrasound. the vital signs of all patients were monitored every day. mrcsum assessment of peripheral muscle strength, 30s sitting test, modified barthel index, borg dyspnea score, arterial blood gas analysis and bedside diaphragm ultrasound monitoring were performed at admission and discharge. finally, statistics were made on the use of non-invasive ventilator, endotracheal intubation, new complications (pressure sore, aspiration, thrombus, etc.) and the time of patients getting out of bed for the first time.the end point of the experiment was 28 days.

Eligibility criteria:
inclusion criteria: * the age is ≥ 18 years old; * the hemodynamics is stable; * 50 \< heart rate \< 120 beats / min ; * 90 \< systolic blood pressure \< 200mmhg ; * 55 \< mean arterial pressure \< 120mmhg; * do not increase the dose of pressor drugs for at least 2 hours; * intracranial pressure is stable and there are no seizures within 24 hours; * the respiratory state is stable; * the patient's finger pulse oxygen saturation ≥ 88%; * 10 \< respiratory frequency \< 35 beats / min. exclusion criteria: * pregnancy; * acute cardio-cerebrovascular events; * spinal or limb fractures; * active bleeding.
68ga-psma pet/ct in detecting prostate cancer recurrence in patients with elevated psa after initial treatment

Conditions: Prostate Adenocarcinoma; PSA Failure; Recurrent Prostate Carcinoma

Summary: the purpose of this research study is to see if recurrent prostate cancer can be identified using a special procedure called a positron emission tomography (pet) scan. pet/ct is used to describe information regarding the function, as well as location and size of a tumor.

primary objectives: i. to evaluate 68ga-psma-11 pet/ct for detection of recurrent prostate cancer after initial therapy in patients with elevated psa. psma refers to prostate-specific membrane antigen. eligible participants will undergo baseline assessments at enrollment. study participants will receive 68ga-psma-11 and undergo a pet/ct. participants will be contacted at 24 to 72 hours following the scan in order to capture potential late occurring adverse events. clinical follow up of participant at 3 to 12 months following the scan in order to analyze secondary endpoints.

Eligibility criteria:
inclusion criteria: * histopathological proven prostate adenocarcinoma * rising prostate-specific antigen (psa) after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy) * post radical prostatectomy (rp) - american urology association (aua) recommendation * psa greater than 0.2 ng/ml measured 6 to 13 weeks after rp * confirmatory persistent psa greater than 0.2 ng/ml (total of two psa measurements greater than 0.2 ng/ml) * post-radiation therapy -american society for radiation oncology (astro)-phoenix consensus definition * a rise of psa measurement of 2 or more ng/ml over the nadir * karnofsky performance status of ≥ 50 (or eastern cooperative oncology group \[ecog\] / world health organization \[who\] equivalent) * able to provide written consent exclusion criteria: * investigational therapy for prostate cancer. * unable to lie flat, still or tolerate a positron emission tomograpy (pet) scan. * prior history of any other malignancy within the last 2 years, other than skin basal cell or cutaneous superficial squamous cell carcinoma that has not metastasized and superficial bladder cancer.