Kornimate/medical-research-clean huggingface dataset:
study of circulating cancer cells in patients with metastatic breast, ovarian, colon, or pancreatic cancer

Conditions: Breast Cancer; Colorectal Cancer; Ovarian Cancer; Pancreatic Cancer

Summary: rationale: counting the number of circulating cancer cells in samples of blood from patients with metastatic cancer may help doctors find out how much the cancer has spread. purpose: this research study is looking at the number of circulating cancer cells in patients with metastatic breast cancer, ovarian cancer, colon cancer, or pancreatic cancer.

objectives: * to assess frequency of circulating tumor cells (ctcs) in patients with metastatic ovarian, breast, pancreatic, and colon cancers. * to assess the variability in number of ctcs between patients with the same tumor type. * to correlate the number of ctcs with extent of tumor burden as measured by tumor markers, imaging, and the number of metastatic sites and proliferation and apoptotic markers. outline: blood samples are collected before treatment and analyzed using molecular detection techniques to detect circulating cancer cells. samples are assessed by immunofluorescence for markers of proliferation and survival (e.g., egfr, phosphorylated egfr, akt, phosphorylated akt, cytokeratins, mapk, src, and fak).

Eligibility criteria:
disease characteristics: * radiographic or marker evidence of metastatic ovarian, breast, pancreatic, or colon disease * hormone receptor status not specified patient characteristics: * menopausal status not specified * no history of any prior cancer prior concurrent therapy: * no prior therapy for metastatic disease

Keywords: male breast cancer stage iv breast cancer stage iv ovarian epithelial cancer stage iv ovarian germ cell tumor stage iv pancreatic cancer stage iv colon cancer ovarian sarcoma
the safety and effectiveness of nevirapine plus nelfinavir in hiv-1 infected patients who have taken stavudine

Conditions: HIV Infections

Summary: to determine the potential effects of 28 days of nevirapine treatment on the steady-state pharmacokinetics of nelfinavir and of stavudine (d4t), and to further evaluate the pharmacokinetics of nevirapine in combination with nelfinavir, and d4t compared to the historical controls treated with nevirapine but without nelfinavir or d4t. to determine the efficacy of long-term combination therapy of nevirapine, nelfinavir and d4t on viral load in patients who are non-nucleoside reverse transcriptase inhibitor (nnrti) and protease inhibitor naive, and have \<= 6 months prior d4t exposure at the time of screening.

the trial is an open-label study in patients with hiv-1 infection who are naive to treatment with nnrti and protease inhibitor classes of antiretroviral drugs and have \<= 6 months prior exposure to d4t at the time of screening. part i of this trial is an investigation of potential pharmacokinetic interaction between nevirapine and nelfinavir in hiv-1-infected adults treated with d4t. part ii is an investigation of the long-term antiviral activity of the combination of nevirapine and nelfinavir on viral load as measured by hiv-1 rna.

Eligibility criteria:
inclusion criteria patients must have: * documented hiv infection. * cd4+ cell count \>= 100 cells/mm3. * plasma hiv-1 rna \>= 5000 copies/ml. prior medication: allowed: previous antiretroviral therapy with zidovudine, lamivudine, didanosine, and dideoxycytidine. exclusion criteria co-existing condition: patients with the following symptoms and conditions are excluded: * malabsorption, severe chronic diarrhea, or the inability to maintain adequate oral intake. * undergoing treatment for an active infection. * hepatic insufficiency due to cirrhosis. * renal insufficiency. 1. systemic treatment with corticosteroids or drugs known to be hepatic enzyme inducers or inhibitors within 14 days of entry. substances in these categories include: * macrolide antibiotics (erythromycin, clarithromycin, azithromycin, dirithromycin), azole antifungals (ketoconazole, fluconazole, itraconazole), rifampin, rifabutin, and phenytoin. * previous exposure to non-nucleoside reverse transcriptase inhibitors (nnrtis) such as delavirdine, loviride, dmp 266, or nevirapine and/or protease inhibitors (pi) such as saquinavir, ritonavir, indinavir, and nelfinavir. * \> 6 months previous exposure to d4t. * investigational drugs within 30 days of first dose of study medication. * any antineoplastic agent within 12 weeks before starting study medication. radiotherapy, other than local skin radiotherapy treatment, within 12 weeks prior to study. 1. history of intravenous drug abuse or alcohol or substance abuse considered by the investigator and bipi medical monitor to be a significant impairment to health and compliance. * heavy smokers (e.g., \> 20 cigarettes per day).

Keywords: hiv-1 drug therapy, combination nevirapine stavudine rna, viral nelfinavir anti-hiv agents viral load
effectiveness of stroke riskometer apps in improving awareness and stroke risk probability

Conditions: Stroke; Cardiovascular Diseases; Risk Factor, Cardiovascular

Summary: this intervention study using the stroke riskometer apps as health promotion and disease prevention tools for the stroke prevention. study will specifically target the young adult population (18-50 years old) who are the population at risk for young stroke. the study will determine the effectiveness of stroke riskometer apps by assessing the awareness (knowledge, perception of stroke risk and intention to change behaviours) using the translated abcd risk questionnaire and stroke risk probability using stroke riskometer apps.

this intervention study is non-blinded, parallel-group cluster randomized controlled trial with 1:1 allocation ratio will be implemented in kelantan, malaysia with sample size of 58 each groups. the study will have four points of data collection (for abcd risk questionnaire) in 6 weeks of intervention study. primary outcome will be analysed using the linear mixed effect model. not only the effectiveness of stroke riskometer apps, the investigators also able to get baseline stroke risk among young adult population in kelantan, malaysia. however, because of the time and budget limiting, the investigators only able to handle in kelantan population and within 6 weeks duration. this study will produce good impact; (a) targeting young adult population in response to young stroke incidence nationally and internationally, (b) tool that the investigators used will be a good starting to health promotion and disease prevention in malaysia (model of valid and comparable stroke risk calculator, modules that used by stroke riskometer apps), (c) comparing to current practices of non-communicable diseases (ncds) prevention strategies - may need a practical and new effective strategy especially to catch up the newer generation at risk other than depending on health promotion and disease prevention program and leaflets promotion in health clinics.

Eligibility criteria:
inclusion criteria: * all consented young adult (aged 18 - 50 years old) who are kelantan resident, can understand malay language and own a smartphone. exclusion criteria: * non-malaysian and ever diagnosed of stroke and psychiatric problem.

Keywords: stroke cardiovascular diseases risk probability awareness mobile apps
biowave high-frequency neurostimulation versus tens for the treatment of chronic low back pain

Conditions: Chronic Pain; Lumbar Pain Syndrome; Low Back Pain

Summary: this will be a multicenter randomized crossover clinical trial comparing the therapeutic efficacy of biowave therapy versus tens for the management of chronic low back pain. this study also aims to evaluate the impact of these therapies on physical activity, patient perception of therapeutic efficacy, and activities of daily living.

this will be a multicenter randomized crossover clinical trial comparing the therapeutic efficacy of biowave therapy versus tens for the management of chronic low back pain. this study also aims to evaluate the impact of these therapies on physical activity, patient perception of therapeutic efficacy, and activities of daily living. patients will start a 30 minute treatment session with either biowave therapy or tens device followed by a 30 minute washout and ending with a final 30 minute treatment. patients will then be instructed to perform two 30 minute treatment sessions daily at home for 2 weeks. follow-up will be after 2 weeks and the patients will be assessed in clinic for physiologic measures of pain response. a washout period of 2 weeks will follow and the patients will crossover to receive the alternative treatment.

Eligibility criteria:
inclusion criteria: * subject must have signed consent before study entry * subject must have a body weight of 45 kg or more and a body mass index (bmi) of 40 kg/m2 or less. * subject must be aged 18-85 on the date of enrollment and subjects consecutively enrolled * subject must have a qualifying baseline pain score of≥5 * subject must have a stable pain medication regimen for a period of at least 2 weeks prior to study enrollment. both medication dosages and total number of medications must be stable prior to initiation. * subject's pain indication must be defined as chronic low back pain exclusion criteria: * subject has a known history of allergic reaction or clinically significant intolerance to medical adhesives, glues, or textiles. * subject is currently receiving chronic opioid therapy defined as \>30 morphine equivalents units per day (daily use for \>2 weeks) * subject has an implanted spinal cord stimulator (scs). * subject has any clinically significant clinical, physical, laboratory, or radiographic finding at screening that, in the opinion of the investigator, contraindicates study participation. * subject is currently pregnant. * subject has history of or current medical, surgical, post surgical, or psychiatric condition that would confound interpretation of safety, tolerability, or efficacy, (eg, uncontrolled diabetes mellitus, uncontrolled hypertension, hemodynamic instability, or respiratory insufficiency, cancer or palliative care). * subject received an experimental drug or used an experimental medical device within 30 days prior to screening or has previously participated in this trial. * subject is unable to comply with the requirements of the study

Keywords: chronic low back pain lumbar pain syndrome
combination of iv ascorbic acid and adebrelimab in metastatic colorectal cancer

Conditions: Colorectal Cancer; Vitamin C; GLUT3

Summary: previous preclinical study has shown that high levels of ascorbic acid (aa) possesses the ability to kill human colorectal cancer cells and high expression of glut3 will augment the efficacy of aa. to date, no previous studies have investigated the combination of therapeutic role of aa and pd-l1 antibody in metastatic colorectal cancer with high expression of glut3. this protocol is a randomized controlled study of aa infusions combined with adebrelimab and folfox +/- bevacizumab versus treatment with folfox +/- bevacizumab alone in metastatic colorectal cancer patients with high expression of glut3.


Eligibility criteria:
inclusion criteria: * age≥18 years, ≤75 years; histologically proven peritoneal metastatic adenocarcinoma of colorectal cancer, unresectable metastatic disease; ihc confirmed strong positive glut3; measurable disease; eastern cooperative oncology group (ecog) performance status 0 to 1; life expectancy of at least 12 weeks; anc ≥1,500/mm3; hemoglobin \> 8g/dl; platelet ≥ 100,000/mm3; laboratory at baseline evaluation for inclusion in the study: creatinine ≤1.5x upper limit \[if the creatinine is elevated, but ≤1.5x the uln, a 24 hour creatinine clearance will be obtained, creatinine clearance \> 50 ml/min (calculated according to cockroft and gault)\]; transaminase (ast/alt) ≤2.5x upper limit of normal and bilirubin levels ≤1.5x upper limit of normal without liver metastasis; transaminase (ast/alt) ≤5x upper limit of normal and bilirubin levels ≤1.5x upper limit of normal with liver metastasis; written informed consent exclusion criteria: * prior treatment for metastatic disease (adjuvant therapy with fluoropyrimidines +/-oxaliplatin based regimens allowed if stopped 12 months prior to registration on study); surgery (excluding diagnostic biopsy) or irradiation within 3 weeks prior to study entry; administration of any investigational drug or agent/procedure, i.e. participation in another trial within 4 weeks before beginning treatment; concurrent chronic systemic immune therapy, chemotherapy, radiation therapy (palliative radiation therapy allowed) or hormone therapy not indicated in the study protocol; brain metastasis (known or suspected); pregnant or lactating women; other uncontrolled concomitant illness, including serious uncontrolled intercurrent infection; known allergy or any other adverse reaction to any of the drugs or to any related compound; previous (within 5 years) or concurrent malignancies at other sites with the exception of surgically cured or adequately treated carcinoma in-situ of the cervix and basal cell carcinoma of the skin; patients with low or moderate expression of glut3.
combination stem cell therapy for the treatment of severe coronary ischemia

Conditions: Coronary Ischemia; Coronary Disease; Coronary Artery Disease; Coronary Atherosclerosis; Coronary Arteriosclerosis

Summary: the purpose of this research study is to determine if the infusion of a combination of stem cells obtained from the bone marrow of the same patient will contribute to the formation of new blood vessels in patients with symptomatic severe coronary ischemia. in this trial we will study the safe use of this therapy and its effects on making new blood vessels will be evaluated. coronary ischemia is intractable angina due to severe coronary artery disease which can seriously decrease blood flow to the heart. ci needs a comprehensive treatment since the condition will not improve on its own. the overall goal of the treatment is to increase blood flow to the heart and improve symptoms of angina. the study hypothesis is based on the concept that the process of formation of new blood vessels is complex and requires the participation of several types of stem cells and growth factors. the lack of any of these components will produce vessels which are immature and unable to provide appropriate blood supply to the heart. patients eligible to participate in this study are those suffering from severe blockages to the vessels of the heart and are not candidates for percutaneous revascularization or surgical procedures. once the final mixture of stem cells is prepared, the cells will be intracoronary infused through a catheter into the blocked vessel of the heart. studies will be performed to evaluate if the intracoronary infusion of stem cells is safe, feasible and works. patients will be evaluated for 6 months after cell transplant.


Eligibility criteria:
inclusion criteria: * male or female age 18-20 * angina pectoris: ccs class ii or iv or angina symptom equivalent * 70% blockage in at least one epicardial vessel documented within 6 months * stable medical therapy * reversible perfusion defects by spect * not a candidate for percutaneous intervention or coronary by-pass surgery exclusion criteria: * previous angiogenic therapy or myocardial laser therapy * severe valvular heart disease * recent malignancy or radiation therapy within 6 months * renal insufficiency with creatinine greater that 2.7 * white blood count greater than 13,000 or lower than 3,000 * platelet count lower than 60,000 or higher that 500,000 * pregnant or planning to become pregnant * history of skeletal muscle disease * ast or alt greater than two times upper limit of normal
effect of botox injection in anterior belly of digastric on skeletal relapse following mandibular advancement surgery

Conditions: Orthognathic Relapse

Summary: the purpose of this study is to test whether botox injection in anterior belly of digastric muscle in bsso for mandibular advancement surgery could reduce the tendency of postoperative relapse. research question: (p) in patient has skeletal class ii mandibular retrognathism, (i) will botox injection in anterior belly of digastric. (o) affect the relapse of the mandible after mandibular advancement orthognathic surgery? participants will be undergo botox injection in anterior belly of digastric and bilateral sagittal split surgery

in the intervention group: botulinum toxin type a will be first injected into anterior belly of digastric muscles 2-3 days prior to any surgical intervention (for the btx to be clinically effective). a total of 20 u of botox will be injected bilaterally by using 25g needle, 1 cc insulin syringe through extra oral approach in 4 point. intra-operative procedures: access through a vestibular sagittal split incision for mandible will be carried out. dissection and reflection to reach the bone will be carried out. * the cutting guide of the mandible will be placed onto the exposed bony surface and manipulated to the best fit. then, the guide will be fixed using four 2.0-mm screws to avoid any mobilization during drilling of the reference holes. sixteen reference holes will be established using the cutting guide; eight on each side. * then, a reciprocating saw will be used to perform the planned bilateral sagittal split osteotomy. after adequate mandibular mobilization and removal of bony interferences, the mandible will be repositioned using the patient-specific osteosynthesis material guided by the previously established reference holes and fixed using 2.0-mm screws. * in bi-max surgery the maxillary cutting guide will be fixed in the same manner and lefort i osteotomy will be carried out. * after adequate mobilization, the maxilla will be repositioned by the patient specific osteosynthesis material using the reference holes made by cutting guide and fixed using 2.0-mm screws. * all incisions were closed with 4-0 resorbable sutures.

Eligibility criteria:
inclusion criteria: * patients need bilateral sagittal split osteotomy for correction of skeletal class ii malocclusion (mandibular retrognathism). * age of the patient above 18 years. * all patients are free from any systemic disease that may affect normal bone healing. exclusion criteria: * patient with history of facial bone trauma, cleft lip or palate. * intra-bony lesions or infections that may interfere with surgery. * previous orthognathic surgeries. * patients with relative contraindications to (btx) injection such as pregnancy, lactation, neuromuscular diseases (e.g., myasthenia gravis), motor neuron disease, allergy to any of the components of (btx).

Keywords: mandibular advancement orthognathic relapse
ambulate vascade mvp same day discharge retrospective registry

Conditions: Atrial Fibrillation

Summary: a multi-center, retrospective, single arm post market registry to evaluate procedural outcomes data using the cardiva vascade mvp venous vascular closure system (vvcs) for the management of the femoral venotomy after catheter-based atrial fibrillation interventions with or without another arrythmia performed via 6-12f procedural sheaths with single or multiple access sites per limb for patients who are discharged the same day.


Eligibility criteria:
inclusion criteria: 1. ≥18 years of age; 2. underwent catheter-based ablation for atrial fibrillation with or without another arrythmia. 3. vascade mvp was the only closure device utilized. 4. were discharged the same calendar day as the index procedure. 5. completed a soc follow-up \> 7 days post-procedure. exclusion criteria: 1. any additional procedure(s) involving femoral arterial or venous access in either limb within the soc follow up period as defined by each site (minimum 7 days post-procedure)
transitional treatment of adolescents in family therapy

Conditions: Substance Abuse

Summary: the purpose of this study is to test different treatments to reduce relapse for drug-abusing adolescents who have completed family therapy. adolescents receive 12 weeks of family therapy, designed to strengthen family relationships and develop skills for helping the adolescent avoid drug use. then they are randomly assigned to receive one of three eight-week follow-up treatments: phone calls from a project therapist, group therapy, or a customized schedule of therapist visits with the adolescent, the adolescent's family and teachers, coaches, probation officers and others who can help the adolescent reach or maintain abstinence. families are assessed using questionnaires and interviews before, during and after treatment, to provide information about family functioning, the adolescent's drug use, the adolescent's peers and other factors that may contribute to treatment success or failure. adolescents also provide urine specimens for drug screening at assessment visits. study investigators expect the study will show that a functional family environment and insulating adolescents from the influence of peers who use drugs will help prevent relapse for adolescents who have received family therapy.


Eligibility criteria:
inclusion criteria: 1. at least one parent, step-parent, or surrogate parent willing to participate in the study 2. 13 to 18 years if age 3. meets dsm-iv (apa, 1994) diagnostic criteria for substance abuse or dependence 4. lives in the albuquerque metropolitan area or surrounding communities with a parent, step-parent, or surrogate parent; and 5. sufficient residential stability to permit probable contact at follow-up (e.g., not homeless at time of intake). exclusion criteria: 1. evidence of psychotic or organic state of sufficient severity to interfere with understanding of study instruments and procedures 2. adolescent deemed dangerous to self or others during evaluation 3. services other than outpatient treatment required for the adolescent (e.g., inpatient, detoxification) 4. adolescent already has participated in treatment project at cfar; and 5. a sibling is already participating in project.

Keywords: adolescent substance abuse
muscle activity of the upper limb between task-specific and robot assisted training among individuals post stroke

Conditions: Stroke

Summary: the investigators compared the activity and fatigue of upper extremity muscles, pain levels, subject satisfaction levels, perceived exertion, and number of repetitions in task-specific training (tst) compared with robot-assisted training (rat) in individuals post-stroke.

twenty sub-acute post stroke subjects received one tst and one rat. they marked the pain level in their paretic extremity before and after each session. muscle activity levels and fatigue and number of repetitions were monitored during each session. the subjective assessment questionnaire of treatment and the borg scale were administered post-session.

Eligibility criteria:
inclusion criteria: * 18 to 85 year old individuals up to three months following stroke * national institutes of health stroke scale (nihss) score 3-15 * intact cognitive function * mild to moderate weakness of the affected hand * normal or corrected eyesight exclusion criteria: * neurological, cardio-vascular or orthopedic impairment, unrelated to the stroke, which restricts upper limb function * a pace-maker