Kornimate/medical-research-clean huggingface dataset:
clinical study assessing outcomes, adverse events, treatment patterns, and quality of life in patients diagnosed with mycosis fungoides cutaneous t-cell lymphoma

Conditions: Mycosis Fungoides

Summary: the valchlor prove study is a multi-center, prospective, observational, us-based drug study that longitudinally follows patients with mycosis fungoides cutaneous t-cell lymphoma (mf-ctcl) who are receiving therapy with valchlor. patients will be followed prospectively for a maximum of 2 years from the date of signed informed consent (enrollment) until end of study. continuation in the study is not contingent on continuation of valchlor.

this is a multi-center, prospective, observational, us-based drug study. all consecutive mycosis fungoides cutaneous t-cell lymphoma (mf-ctcl) patients being treated with valchlor will be invited to enroll in this study.patients will undergo clinical assessments and receive standard medical care, as determined by the patients' physician, in the real world setting. with the exception of protocol-required patient completed questionnaires for symptoms and qol, there are no specific or mandated clinical assessments to be performed. patients will be followed prospectively for a maximum of 2 years

Eligibility criteria:
inclusion criteria: * all adult patients (≥ 18 years of age) diagnosed with mf ctcl and being treated with valchlor. this includes patients newly initiating valchlor or patients continuing treatment with valchlor: * patients newly initiating valchlor are patients who have their first office visit after having initiated valchlor. * patients continuing treatment with valchlor includes patients who are actively taking valchlor on the day of enrollment. * signed patient informed consent. exclusion criteria: • none

Keywords: prove ctcl mechlorethamine cutaneous t-cell lymphoma mycosis fungoides cutaneous t-cell lymphoma valchlor dermatology mf-ctcl mycosis fungoides oncology
prognostic value of baseline computed tomography (ct) perfusion parameters of pancreatic cancer for patients undergoing stereotactic body radiotherapy or surgical resection

Conditions: Pancreatic Cancer

Summary: the purpose of this study is first, to determine whether baseline perfusion characteristics of pancreatic cancer, as characterized by ct perfusion studies, can predict tumor response to treatment by stereotactic body radiotherapy (sbrt). the second goal of this study is to determine whether baseline perfusion characteristics in those patients with resectable pancreatic cancer correlate with immunohistologic markers of angiogenesis such as microvessel density and vascular endothelial growth factor (vegf) expression.


Eligibility criteria:
inclusion criteria: 1. suspected and/or biopsy-proven pancreatic adenocarcinoma, and 2. referral to radiology for pre-treatment baseline pancreatic protocol ct. exclusion criteria: 1) are absolute contraindications to intravenous iodinated contrast or ct scan.
valproate versus ketorolac versus metoclopramide

Conditions: Acute Migraine

Summary: this randomized study is testing 3 different intravenous medications to see which one is best for acute migraine. the three medications are metoclopramide, valproate, and ketorolac.

one million patients present to us emergency departments (ed) annually for treatment of acute migraine headache. a variety of parenteral medications are used to treat acute migraine, but none offer rapid and complete headache relief without side effects. preliminary studies have suggested that intravenous valproate, an anti-epileptic medication with established efficacy as a migraine preventive, may be useful for the treatment of acute migraine. we propose a randomized, comparative efficacy trial in which intravenous valproate is compared to two standard parenteral therapies for acute migraine. there will not be a placebo control. included subjects will be adults 64 years and younger who meet international headache society criteria for acute migraine, who do not have clinical evidence of secondary (organic) headache, and who do not have allergy or contra-indication to the investigational medications. the investigational medications are 1gm of valproate, 10mg of metoclopramide, and 30mg of ketorolac. patients will be approached for participation and randomized at the time of presentation to the ed. pain will be assessed on an 11 point (0 to 10) verbal pain scale, validated for use in acute pain trials. medication will be infused as a slow intravenous drip. the primary outcome will be an improvement in headache intensity one hour after initiation of the intravenous drip. secondary outcomes include assessments of pain, functional disability, adverse events, and satisfaction with the investigational medication one, two and 24 hours after initiation of the intravenous drip. the primary analysis will use a student's t-test for independent samples and involve three pair-wise comparisons. using an alpha of .017 (to account for the three pairwise comparisons), a standard beta, and a validated minimum clinically significant difference on the verbal pain scale, we calculated the need for 330 subjects. an interim analysis will be conducted to determine lack of efficacy of valproate.

Eligibility criteria:
inclusion criteria: * ihs migraine without aura * ihs probable migraine (all migraine without arua criteria must be met except duration may be \>72 hours or \<4 hours) exclusion criteria: * allergy or contra-indication to investigational medication

Keywords: migraine emergency metoclopramide ketorolac valproate
efficacy of exercise program on osteosarcoma patients

Conditions: Osteosarcoma

Summary: this study will be conducted to investigate the effect of selected therapeutic exercises compared to standard exercise program in improving rom, muscle strength and functional outcomes in distal femur osteosarcoma patients who have undergone tumor resection and modular knee endoprosthesis.

osteosarcomas (os) are the most common primary bone tumor and third most common cancer among children and adolescents after lymphomas and brain cancers (wang et al., 2018; luetke et al., 2014). it is a primary malignant bone tumor with a worldwide incidence of 3.4 per million people per year (mirabello et al., 2009). they are characterized by the production of osteoid, or immature bone, by malignant mesenchymal cells (wang et al., 2018; (luetke et al., 2014). patients displayed some persisting physical difficulties including incapability to perform active range of motion (rom), decreased muscle strength, altered gait and sit-to-stand patterns, yet they maintained high levels of emotional acceptance and coping. a surprising but important finding was the persisting hip weakness in both operated and non-operated limbs, which extends up to 42 months after resection around the knee. this indicates that continued rehabilitation programs emphasizing hip strengthening should be considered for these patients, even years after surgery (beebe et al., 2009). furthermore, rom exercises, strengthening exercises and balance exercises improve overall quality of life (qol) for these patients (marchese et al., 2006).

Eligibility criteria:
inclusion criteria: 1) patients diagnosed as distal femur osteosarcoma. 2) age of the patient from 15-50 years old 3) patients undergoing tumor resection and knee endoprosthetic reconstruction six weeks ago. 4) both gender - exclusion criteria: 1) lung and bone metastasis 2) end stage patients receiving palliative chemotherapy 3) patients undergoing l.l amputation or rotationplasty (any surgical procedures rather than knee endoprosthetic reconstruction). 4) local tumor recurrence 5) sever psychiatric illness 6) heart disease or any condition that prevent the patient from participation in exercise -
sargramostim or hypertonic saline before sentinel lymph node biopsy in treating patients with stage ib-ii melanoma

Conditions: Stage IB Melanoma; Stage IIA Melanoma; Stage IIB Melanoma; Stage IIC Melanoma

Summary: this randomized phase iii trial studies sargramostim before sentinel lymph node biopsy to see how well it works compared to hypertonic saline before sentinel lymph node biopsy in treating patients with melanoma. biological therapies, such as sargramostim, may stimulate the immune system in different ways and stop cancer cells from growing. it is not yet known whether sargramostim is more effective than hypertonic saline in treating patients with stage ib-ii melanoma undergoing sentinel lymph node biopsy.

primary objectives: i. to determine if the alterations in morphology and phenotype to the sentinel lymph nodes are reversible. ii. to determine if the restoration of the morphology or phenotype of sentinel lymph nodes results in diminished regional tumor burden. outline: patients are randomized to 1 of 2 treatment arms. arm i: patients receive sargramostim subcutaneously (sc) 3-5 days prior to undergoing sentinel lymph node biopsy. arm ii: patients receive hypertonic saline sc 3-5 days prior to undergoing sentinel lymph node biopsy. after completion of study treatment, patients are followed up for 30 days.

Eligibility criteria:
inclusion criteria: * patients with stage ib or ii cutaneous melanoma * primaries on the torso, upper and lower extremities and head and neck region * skin biopsy performed at least 5 days and no longer than 10 weeks from the time of initial entry into the study * bilirubin \< 2.0 ng/dl * creatinine \< 3.0 ng/dl * able to understand the consent competent to sign * eastern cooperative oncology group (ecog) performance status 0 or 1 exclusion criteria: * prior wide excision with diameter of the excision \> 3 cm * primary melanoma arises from the eye or mucus membranes * clinical evidence of regional, intransit ,or distant metastases * second invasive melanoma * prior surgical procedures that would alter the drainage patterns and would prevent us from identifying sentinel lymph nodes (sn) * patients with primary or secondary immunodeficiencies * pregnancy * known allergy to sargramostim (gm-csf) * history of cardiac disease, in particular, supraventricular tachycardia
locally ablative therapy in oligo-progressive genitourinary tumors (layover)

Conditions: Prostate Cancer; Oligoprogressive; Urothelial Carcinoma; Renal Cell Carcinoma

Summary: this is a phase 2 pragmatic study that evaluates the clinical benefit of continuing systemic therapy with the addition of locally ablative therapies for oligo-progressive solid tumors as the primary objective. the primary outcome measure is the time to treatment failure (defined as time to change in systemic failure or permanent discontinuation of therapy) following locally ablative therapy.

this is a phase 2 pragmatic study at a single site that evaluates the clinical benefit of continuing systemic therapy with the addition of locally ablative therapies for oligo-progressive solid tumors as the primary objective. the primary endpoint is disease control at 3 months, defined as continuation in systemic cancer therapy without any changes or permanent discontinuation for 3 months following first day of ablative local therapy. participants will receive ablative local therapy per standard practices in addition to their systemic therapy and will be followed for up to 5 years following ablative local therapy. participants will be assigned stereotactic ablative radiotherapy (sabr) or interventional radiology (ir) ablation therapy per the discretion of treating radiation oncologist and/or interventional radiologist.

Eligibility criteria:
inclusion criteria: 1. must have one of the following histologically and/or biochemically confirmed genitourinary malignancies: 1. cohort a: prostate cancer 2. cohort b: urothelial carcinoma 3. cohort c: renal cell carcinoma 2. provision of signed and dated informed consent form. 3. stated willingness to comply with all study procedures and availability for the duration of the study. 4. age ≥18 years at time of consent. 5. currently on systemic therapy and a candidate to continue their current line of systemic therapy with no more than a planned 30-day break to allow for local ablative therapy. 6. ≥ 1 line of systemic therapy for metastatic disease with ≥ 3 months of clinical benefit on most recent line of systemic therapy prior to the development of new metastatic lesions. \[clinical benefit: treating provider assessment that majority of the tumor burden is stable on current systemic treatment and not requiring an immediate change in systemic treatment\] 7. ≤ 5 progressing or new metastatic lesions. 8. all progressing or new metastatic lesions can be safely treated with locally ablative therapies at discretion of treating radiation oncologist and/ interventional radiologist. exclusion criteria: 1. medical comorbidities precluding locally ablative therapies. 2. history of treatment related toxicities that limit or prohibit application of locally ablative therapies. 3. progressing intracranial lesions.
whatsapp-based psycho-socio-educational intervention (welove) for prevention of psychological and sleep problems in pregnant women and their partners: a three-arm double-blinded pilot randomised controlled trial

Conditions: Sleep Problems; Psychological; Well-Being, Psychological

Summary: objectives: (1) evaluate the feasibility and acceptability of the whatsapp-based psycho-socio-educational intervention (welove); (2) preliminarily examine the effects of the intervention on psychological symptoms (depression, anxiety, stress symptoms), sleep quality, and life satisfaction; and (3) preliminarily examine the interdependence between psychological symptoms and sleep quality in pregnant women and their partners. methods: the investigators will use whatsapp to provide the six sessions of the intervention, which include psychological, social, and educational components. a three-arm double-blinded pilot randomised controlled trial (rct) is used in 60 couples, followed by individual face-to-face interviews for process evaluation in 10 to 20 couples based on data saturation. participants will be assigned to one of three groups and 20 couples per group: intervention 1 (couples for welove), intervention 2 (pregnant women for welove), or the control group (use whatsapp as normal). participants will be assessed pre- and post-intervention. generalised estimating equation analysis and thematic analysis will be performed to examine the research objectives.

study design a prospective randomised double-blind, three-arm, parallel-group design will be adopted. the report of the trial will follow the consolidated standards of reporting trials guidelines for an internet-based intervention (consort-ehealth).

Eligibility criteria:
inclusion criteria: * pregnant with a gestation of \>12 to 28 weeks and their partners over 18 years * able to read and understand chinese * have electronic devices with whatsapp that can contact the internet * can provide written consent and voluntary participation in this study exclusion criteria: * current severe medical illnesses * psychological and sleep disorders

Keywords: couple-based intervention psycho-socio-educational intervention (welove) psychological well-being sleep outcome
prognostic value of circulating tumor dna dosing in patients in neoadjuvant breast neoplasia

Conditions: Breast Neoplasm

Summary: this is a cohort, single-center, prospective study that seeks to analyze the circulating tumor dna (ctdna) in patients diagnosed with breast cancer, who will undergo neoadjuvant treatment.

breast cancer is a major public health problem, being the most common cancer in women worldwide. breast cancer can be diagnosed through multiple tests, including an imaging and tissue biopsy. however, accurate assessment and prediction of the response is a major challenge. circulating tumor dna (ctdna) has shown promise in the detection of breast cancer and clinical and cancer outcomes. this study aims to evaluate a possible correlations between ctdna levels with the pathological complete response and detection of residual disease after neoadjuvant therapy in patients with breast cancer. in order to start ctdna surveillance, patients will be asked to participate in blood draws, every 15 days, during neoadjuvant standard institutional treatment and allow study staff to review medical records.

Eligibility criteria:
inclusion criteria: * information to the patient and signed informed consent; * locally advanced breast cancer that is a candidate for neoadjuvant therapy; * histological diagnosis of localized invasive breast carcinoma, confirmed by the pathologist, with or without expression of hormone receptors, and/or with the presence of her-2. exclusion criteria: * metastatic breast cancer (stage iv); * additional invasive malignant disease; * known psychiatric or substance abuse disorders that may interfere with cooperation with study requirements; * presents any organic condition that makes it impossible to carry out chemotherapy treatment; * pregnant or lactating women * received previous treatment for breast cancer.

Keywords: breast cancer liquid biopsy ctdna pathologic complete response
use of preoperative sodium bicarbonate among women with obstructed labor

Conditions: Obstructed Labor

Summary: the goal of this clinical trial is to determine a universal safe and effective dose of sodium bicarbonate for use among women with obstructed labour to treat acidosis. it will also learn about the safety of sodium bicarbonate drug among women with obstructed labour. researchers will compare sodium bicarbonate drug to normal saline (a look-alike solution) to see if sodium bicarbonate works to treat acidosis. participants will receive sodium bicarbonate solution or a placebo up to two doses, four hours apart.

oral bicarbonate is a safe, cheap and effective acid buffer, widely used in sports to improve performance because of its ability to prevent and reverse the effects of metabolic acidosis. clinically, it is used in intensive care units to treat patients with overwhelming infections or poisoning. in low resource settings, obstructed labor (ol) is a major problem that accounts for 22% of maternal deaths. the fetal harm of ol comes from intrapartum asphyxia, characterized by accumulation of hydrogen ions that cross the placental barrier to cause fetal acidosis. acidosis causes failure of basic cellular functions resulting into cell death. in a recent randomised clinical trial, the investigators found that 61% of 477 women with ol were acidotic (lactate \>4.8 mmol/l), with a median capillary blood lactate level of 6.9 (3.4-13) mmol/l. the investigators propose an early phase iii, placebo-controlled dose-ranging trial to determine the efficacy and safety of a pre-operative infusion of sodium bicarbonate in women with obstructed labour (ol). in a ratio of 1:1:1: 1 100 mls (8.4g), 150 mls (12.6g) and 200 mls (16.8g) of 8.4% sodium bicarbonate solution, or placebo (50 mls of normal saline 0.9%). the primary outcome will be mean change in acidosis (ph and lactate levels) from baseline. the secondary outcomes will be neonatal death, safety of sodium bicarbonate, pharmacokinetics of sodium bicarbonate in pregnant women, primary postpartum haemorrhage, sepsis, and maternal death.

Eligibility criteria:
inclusion criteria: * patients with obstructed labour * must be a singleton pregnancy * must be a term pregnancy (≥37 weeks of gestation) * must be in cephalic presentation. exclusion criteria: * patients with other obstetric emergencies such as antepartum haemorrhage, preeclampsia and eclampsia (defined as elevated blood pressure of at least 140/90 mm hg, urine protein of at least 2+, any of the danger signs and fits), premature rupture of membranes and intrauterine fetal death. * patients with comorbidities such as diabetes mellitus, sickle cell disease, renal disease, liver disease and heart disease. * patients with hypokalaemia (148 mmol/l) and alkalosis (bicarbonate \>22 mmol/l) because they are more likely to develop adverse drug reactions

Keywords: sodium bicarbonate obstructed labor women uganda
noninvasive positive pressure ventilation for difficult weaning in tracheotomy patients

Conditions: Respiratory Failure

Summary: the investigators adopt noninvasive positive pressure ventilation for weaning in tracheotomy patients innovatively. the investigators randomly allocate the subjects into two groups. one group is weaned by traditional strategy. the other one is weaned by noninvasive positive pressure ventilation by plugging the tracheotomy tube and deflating the cuff.

the investigators adopt noninvasive positive pressure ventilation for weaning in tracheotomy patients innovatively .if patients'conditions met our defined criterions, the investigators randomly allocate two groups. one group adopts traditional weaning strategy, the other adopts noninvasive positive pressure ventilation. if patients' condition deteriorated in group two, the investigators turned them to invasive positive pressure ventilation, until patients adapted in a satisfactory condition, the investigators shift them into noninvasive positive pressure ventilation. the investigators will extubate the tracheotomy tube, if patients are received noninvasive positive pressure ventilation more than 24 to 48 hours. after extubation, the investigators try to wean noninvasive positive pressure ventilation. successful wean is defined weaning mechanical ventilation more than 48 hours.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * tracheotomy mechanical ventilation patients exclusion criteria: * pregnancy * respiratory and hemodynamic instability * recent oral，nasal，facial or cranial trauma or surgery * contra-indications for nasal or facial mask (facial skin lesions,...) * recent history of upper gastro-intestinal surgery * recent history of myocardial infarction * unconscious patients * non cooperative patient

Keywords: noninvasive positive pressure ventilation invasive positive pressure ventilation tracheotomy