Kornimate/medical-research-clean huggingface dataset:
phase i-ii study of carboplatin, vinorelbine and capecitabine in patients with metastatic breast cancer

Conditions: Breast; Cancer

Summary: 1. determine the response rate with this regimen in an anthracycline and taxane resistant cohort of patients.

1. determine the response rate with this regimen in an anthracycline and taxane resistant cohort of patients. 2. determine a maximum tolerated dose of capecitabine in combination with vinorelbine and carboplatin for this patient population. 3. determine the time to relapse after the administration of this regimen.

Eligibility criteria:
inclusion criteria: * patient must have a histological diagnosis of breast cancer with metastasis. * the metastatic disease should be confirmed by biopsy if clinically indicated. * the patient must have measurable or evaluable disease. * age \> 18 years and \< 75 years. * the patient may not have received prior therapy with vinorelbine, capecitabine, carboplatinum, or cisplatinum. * the patient may have received herceptin previously. * the patients must have previously received at least one cycle of chemotherapy. * the patient must have received anthracycline and taxane containing chemotherapy in the past. this may be either in the adjuvant setting or for metastatic disease. resistance is defined as progressive disease while on treatment, with or without an initial response, or relapse/progression within 6 months of completing chemotherapy. * performance status \< 2. * at least 3 weeks must have elapsed since the completion of prior radiation therapy, chemotherapy, or hormonal therapy. the patient must have recovered from all grade 3-4 associated toxicities at the time of registration. measurable or evaluable disease must be outside the previous radiation field or a new lesion must be present. * patients must not receive concurrent hormonal, or biologic therapy, or radiation therapy to measurable or evaluable disease. * the patient should not have uncontrolled cns disease. * laboratory parameters: anc \> l500/ l, platelets \>100 000/ l, creatinine \< 2.0, bilirubin \< 2.0 * informed consent.

Keywords: breast metastatic
administration of tadalafil in patients with benign prostatic hyperplasia

Conditions: BPH With Other Lower Urinary Tract Symptoms

Summary: the aim of the present study is to evaluate the efficacy and safety of once daily administration pde5 inhibitors, tadalafil for 3 months as anti-inflammatory, antiproliferative and relaxant effects in ed with bph patients.


Eligibility criteria:
inclusion criteria: * aged ≥ 45 years and sexually active with symptomatic benign prostatic hyperplasia (no hospitalization 3 months prior to start of treatment). exclusion criteria: * 1. patients with bladder or prostate malignancy. 2. a history of lower urinary tract surgery. 3. history of catheterization. 4. urinary retention. 5. urinary tract infection. 6. stone disease. 7. any neurological disease.
male breast cancer summa health system/akron city hospital experience 1995-2007

Conditions: Breast Cancer

Summary: the primary goal of this retrospective study is to evaluate the male breast cancer patient population at summa health system/akron city hospital over a period of 18 years and compare the findings to historical data. the objectives are to: * identify risk factors. * evaluate stage and histology at the time of presentation. * document treatment modalities and outcomes. * analyze outcomes for comparison to historical data.


Eligibility criteria:
inclusion criteria: * male breast cancer patients diagnosed and/or treated at summa health system/akron city hospital from the reference year of 1995 through 2007.

Keywords: male breast cancer male breast cancer patients diagnosed and/or treated at summa health system/akron city hospital from the reference year of 1995 through 2007.
neurofeedback intervention in children with autism spectrum disorder (asd)

Conditions: Neurofeedback; Autistic Disorder; Autism Spectrum Disorder; Neurodevelopmental Disorders

Summary: this project aims to: * explore the effectiveness of neurofeedback therapy for children diagnosed with autism spectrum disorder (asd) * assess if cognitive functions are affected before and after neurofeedback intervention

neurofeedback is a computer assisted programmed technique that functions by tracing brain electrical activity (eeg) and providing feedback about the brain activity and sends visual and acoustic signals to counter the mismatch in the electrical activity for improvement. it is a course of learning that allows the patient to observe, regulate and modify his/her own brain activity. neurofeedback will be carried out in 35 children with autism spectrum disorder (asd) over a 30-session training period to improve the cognitive functions. this study aims to improve the behavioural and cognitive functions of children and adolescents with neurofeedback therapy. as neurofeedback therapy is a non-invasive treatment with almost no side effects, this study will contribute to practice of effective and scalable assessment and treatment strategy for children and adolescents with asd, utilizing objective tools that have not widely been used in the assessment of cognitive functions for asd. goal is to improve the quality of life of children on the spectrum by enabling them to perform day to day activities of life and to improve their social communication. moreover, this study seeks to be a contribution for creating mass awareness regarding the efficacy of neurofeedback therapy especially in the developing world. hopefully in the future neurofeedback training would be incorporated as a standard of care for asd.

Eligibility criteria:
inclusion criteria: * 7 to 17 year olds (diagnosed by their physician with autism, in accordance with dsm-v (diagnostic statistical manual-v) diagnostic criteria exclusion criteria: any child with a history of * brain injury * bipolar disorder * tourette's syndrome * uncontrolled seizure disorder * major psychiatric disorder * children on medications

Keywords: neurofeedback autism spectrum disorder
corpus luteum and uterine artery doppler with serum p and ca125 in threatened abortion

Conditions: Threatened Abortion

Summary: the purpose of this study is to determine whether assessing color doppler of corpus luteum and uterine artery is useful in predicting patients who will complete pregnancy. the investigators will add to this the usefulness of serum progesterone and ca125 in prediction.

the introduction of doppler ultrasound in obstetrics has allowed evaluating hemodynamic characteristics from the first trimester of pregnancy. for example, kurjak et al.,in one of the first studies using transvaginal pulsed-wave doppler ultrasound in early pregnancies, identified the uterine arteries in 100% of the patients. the flow blood of the corpus luteum was identified in 75% patients. the measures obtained by doppler ultrasonography that may have prognostic value to the evolution of pregnancy include uteroplacental blood flow, also known as trophoblastic flow. jaffe et al. reported that abnormal doppler findings were associated with a significantly higher prevalence of complicated pregnancies, among women with abnormal doppler findings, 43% ended in miscarriage, whereas among women with normal findings only 1.4% of women miscarried.progesterone plays a crucial role in the maintenance of pregnancy. in the presence of sufficient progesterone levels during pregnancy, lymphocytes synthesize a mediator called progesterone induced blocking factor (pibf), which is anti-abortive in mice . besides inducing secretary changes in the endometrium and supporting early pregnancy, it modulates the maternal immune response to prevent fetal rejection and relaxes the uterine smooth muscles .ca-125, well-known as a tumor marker for epithelial ovarian cancer , is a high molecular weight glycoprotein that is produced not only by ovarian cancer, but also by nonovarian tumors, normal epithelia of the peritoneum, the endometrium, the fallopian tube, and the ovary. because ca-125 is also produced by the endometrium, some authors suggest that ca-125 can be used as a marker for endometrial receptivity in patients undergoing ivf . its role as a predictor for pregnancy outcome is controversial .

Eligibility criteria:
inclusion criteria: * patients with pregnancy between 8 to 20 weeks of gestation, * who were diagnosed with threatened abortion. exclusion criteria: * patients with multiple pregnancies, * molar pregnancy, * ectopic pregnancy, * amenorrhea with different etiologies of pregnancy, * maternal history of systemic diseases and uterine anatomic abnormalities * patients who did not have their outcome data through week 20 of gestation due to relocation.

Keywords: ca 125 progesterone doppler corpus luteum
a study of dtc in patients with aids and aids related complex

Conditions: HIV Infections

Summary: to determine if ditiocarb sodium (sodium diethyldithiocarbamate; dtc) restores immune and host defense function; if dtc ameliorates the aids related complex (arc) symptoms in patients with aids and arc; if dtc prevents progression from arc to aids or progression of aids; and if dtc prolongs survival in aids.


Eligibility criteria:
inclusion criteria concurrent medication: allowed: * zidovudine (azt). exclusion criteria co-existing condition: patients with the following are excluded: * active opportunistic infection or progressive kaposi's sarcoma (ks). * dementia. * lymphoma. concurrent medication: excluded within 3 weeks of study entry: * other experimental aids therapy. patients with the following are excluded: * active opportunistic infection or progressive kaposi's sarcoma (ks). patients must be either hiv seropositive or have aids or aids related complex (arc) and have life expectancy of at least 6 months.

Keywords: ditiocarb acquired immunodeficiency syndrome aids-related complex
path to health: an exploration of digital behavioral weight loss approaches

Conditions: Overweight; Obesity; Overweight and Obesity

Summary: the purpose of this initial pilot and feasibility study is to test different digital, behavioral weight loss approaches, with or without human support, using a sequential, multiple assignment, randomized trial (smart) design. all participants in this pilot trial will receive a 3-month mobile health (mhealth) program. the dose of human support will vary by first- and second-line randomizations. the feasibility, acceptability, and preliminary outcomes for each of the treatment sequences will be assessed.

ninety-nine adults, ages 18-65, with overweight or obesity, will be randomized in total. all participants will receive an mhealth program (app) for program duration that includes activity tracking with a fitbit, weight tracking with a smart scale, and an app for diet tracking. at baseline, participants will be randomized to either a a) fully automated kick-off, or b) human-enhanced kick-off. "early responders" will continue with to use app, alone. after 4 weeks, "early non-responders" in both arms will be re-randomized once to one of two augmented interventions with human support: counseling or check-in. assessments will occur at baseline, 1 week, 4 weeks, and 3 months to explore feasibility, acceptability, and preliminary outcomes (weight, self-monitoring adherence, behavioral goal adherence).

Eligibility criteria:
inclusion criteria: * current age: 18-65 years * lives in north carolina * body mass index (bmi) of 27.5-45 kg/m\^2 * ability to read, write, and speak english * ownership of iphone with a data and texting plan * ability to commit to the required counseling sessions (0-5 sessions, based on randomization) * is not living a participant or staff member on this trial * willingness to be randomized to any of the treatment sequences exclusion criteria: * weight loss of more than 10 pounds in the last 6 months that was maintained * a history of weight loss surgery * pre-existing medical condition(s) that prevent them from adhering to a supervised exercise routine * have type 1 diabetes or are currently taking medicine for type 2 diabetes * have recently been diagnosed or treated for cancer * currently pregnant, pregnant within the past 6 months, or plan to become pregnant in the next 6 months * report taking prescription or over the counter medication with a known impact on metabolism or weight * report a history of an eating disorder * history of psychotic disorder or bipolar disorder, or have been hospitalized for depression or other psychiatric disorder within the past 12 months * history of alcohol or substance abuse * current participation in another weight loss program that may interfere with participation in this study

Keywords: behavioral intervention smart (sequential multiple assignment randomized trial)
study on the effect of selenium supplementation on the structure and function of autoimmune thyroiditis

Conditions: Selenium

Summary: to evaluate the effects of exogenous selenium supplementation on autoimmune thyroiditis.

in patients with autoimmune thyroiditis， investigators compared changes in thyroid function, anti-thyroid peroxidase antibody, anti-thyroglobulin antibody, thyroid magnetic resonance t1-mapping values and metabolic indicatorsfrom baseline to the end of treatment (12 weeks)

Eligibility criteria:
inclusion criteria: * men or women between the ages of 18 and 75 * clinical diagnosis of autoimmune thyroiditis, serum tpoab and tgab positive * thyroid function is normal, and no drugs affecting thyroid function such as umetole and serge have been used exclusion criteria: * the contraindications indicated in the chinese instructions of the drug * hypothyroidism, hyperthyroidism * liver function impairment * renal function impairment * claustrophobia * mental disorders
safety and effectiveness of generic fingolimod (sphingomod®, hikma) in patients with relapsing-remitting multiple sclerosis in egypt

Conditions: Relapsing-Remitting Multiple Sclerosis

Summary: the purpose of this observational study is to evaluate the safety and effectiveness of generic fingolimod (sphingomod®, hikma) in patients with relapsing-remitting multiple sclerosis in egypt

this is an observational, prospective, cohort study, where no visits or intervention(s) additional to the daily practice will be performed. in the study sites, patients undergoing routine clinical care for rrms and initiating treatment with generic fingolimod in accordance with the approved summary of product characteristics (spc) will be followed up and assessed for a total of 12 months.

Eligibility criteria:
inclusion criteria: 1. patients who initiate treatment with generic fingolimod at baseline in accordance with the approved summary of product characteristics (spc). 2. males and females who are ≥ 18 years old. 3. patients who had a diagnosis of rrms per 2010 or 2017 revised mcdonald criteria, who are: 1. newly diagnosed who had no prior disease-modifying therapy (dmt), or 2. switched patients from gilenya®, novartis, or 3. switched patients from interferon beta (ifnβ). 4. patients who agree to participate in the study and provide a written informed consent. exclusion criteria: 1. pregnant or lactating female patients and women of childbearing potential not using effective contraception. 2. patients lacking immunity against varicella zoster virus (vzv). 3. patients participating in other clinical studies. 4. patients who meet any of the contraindications to the administration of the study drug according to the approved spc.

Keywords: fingolimod generic fingolimod nervous system multiple sclerosis relapsing-remitting multiple sclerosis cohort study observational study effectiveness safety disease modifying treatments
precision orthodontics: a comparison of custom vs traditional bracket treatment efficiency

Conditions: Dental Malocclusion

Summary: this investigational testing aims to target multiple investigations sites to examine treatment efficiency metrics using a completely digital and patient-specific bracket treatment system for the correction of malocclusions.


Eligibility criteria:
inclusion criteria: * all subjects must be healthy and between the ages of 10 and 65. * eruption of all permanent teeth excluding second and third molars * sufficient labial tooth surface for bonding * no more than one tooth missing from a single arch quadrant * no existing molar tubes or bands exclusion criteria: * presence of systemic diseases, cleft lip and palate, craniofacial anomalies, syndromes affecting bone or teeth, impacted teeth (excluding 3rd molars), and tumors of the parathyroid gland * presence of bridges or implants * cases requiring orthognathic surgery * significant periodontal disease * intake of drugs affecting tooth movement or bone formation (chronic use of non-steroidal anti-inflammatory drugs, bisphosphonates, levothyroxine, or teriparatide drug class) * pregnancy
a study to describe the effectiveness and safety of venetoclax treatment in chronic lymphocytic leukemia (cll) patients in routine clinical practice

Conditions: Chronic Lymphocytic Leukemia (CLL)

Summary: this study will evaluate effectiveness and safety in routine clinical practice in participants starting venetoclax treatment for chronic lymphocytic leukemia (cll).


Eligibility criteria:
inclusion criteria: * participants with diagnosed chronic lymphocytic leukemia (cll) and eligible for venetoclax as per label. * participants for whom the physician has decided to initiate cll treatment with venetoclax. * participants who have been informed verbally and in writing about this study, and who do not object to their data being processed or subjected to data quality control. exclusion criteria: - participants currently participating (or previously participated) in an interventional clinical trial within 30 days prior to venetoclax treatment initiation.

Keywords: chronic lymphocytic leukemia cancer venetoclax observation
a single-center, open-label, single-dose study investigating the safety, tolerability, and pharmacokinetic properties of nalmefene 10 mg tablets in healthy japanese male subjects

Conditions: Alcohol Dependence

Summary: the safety, tolerability, and pharmacokinetics of nalmefene at a single oral dose of 10 mg in healthy japanese male subjects will be evaluated.


Eligibility criteria:
inclusion criteria: * the subject is a japanese male. * the subject is able to read and understand the informed consent form (icf). * the subject has a body mass index (bmi) ≥ 19 kg/m2 and ≤ 25 kg/m2 at the screening visit. * the subject has a resting pulse and heart rate (as read on the ecg) ≥ 45 bpm and ≤ 100 bpm at the screening visit. exclusion criteria: * the subject has taken any prescription drugs, over-the counter medications, vitamin supplements, or supplements containing st. john's wort (hypericum perforatum) within 2 weeks prior to day 1. * the subject has a significant history of alcohol abuse, defined as an alcohol intake greater than 21 units per week. (a unit of alcohol is defined as 250 ml of lager/beer, 100 ml of wine, or 25 ml of spirits.) * the subject has taken any investigational products within 4 months prior to day 1.
distraction method on pain and anxiety during circumcision

Conditions: Pain; Anxiety; Urological Nursing

Summary: circumcision is a common procedure in infants, children and young people around the world for cultural, religious or medical reasons. since this is a painful procedure, it is performed under local anesthesia or general anesthesia. it is recommended to perform this procedure under local anesthesia if there is no risk. although local anesthesia is used during the procedure, pain and anxiety levels of children may increase. distraction methods are commonly used and effective methods to reduce pain and anxiety during painful procedures. the aim of this study was to evaluate the effect of tablet playing during circumcision on pain and anxiety in school age children.

circumcision is a common procedure in the worldwide. to our knowledge, although there have been several randomized controlled trials using video and game techniques, which are distractions to reduce pain and anxiety during painful procedures, no randomized controlled trials using playing the game with tablet to reduce pain and anxiety during circumcision have been found. non-pharmacological studies, such as play therapy, are needed to reduce pain and anxiety in school-age children undergoing circumcision under local anesthesia. the aim of this study is to provide evidence about the effectiveness of playing the game with tablet used to reduce pain and anxiety during circumcision, and to contribute to nursing care in pain management.

Eligibility criteria:
inclusion criteria: * being between 7-12 years * male gender * circumcision with local anesthesia * agreeing to participate in the study exclusion criteria: * presence of any contraindication for circumcision (hemophilia, bleeding disorders, urinary anatomical disorders-hypospadias, epispadias etc.) * any analgesic used 24 hours before circumcision

Keywords: anxiety children circumcision nursing pain
thoracoscopic talc pleurodesis versus bleomycin -tranxemic acid mixture injection in chest tube in malignant pleural effusion

Conditions: Malignant Pleural Effusions (Mpe)- Pleurodesis; Pleurodesis

Summary: comparing two methods to treat fluid build-up in chest for cancer patients:talc powder surgery versus chest tube medicine.

closure of the space where the effusion is recurrently accumulated through talc poudrage in thoracoscopy or bleomycin - tranxemic acid solution injection in chest tube.

Eligibility criteria:
inclusion criteria: - 1. adult patients (more than 18 years) with malignant pleural effusion or highly suspected exudate. 2. fit patients for the procedure selected. exclusion criteria: 1. inability to provide informed consent for the procedure. 2. hemodynamically unstable patients. 3. bleeding diathesis. 4. uncontrolled cough. 5. hypoxic index less than 300. 6. endobronchial obstruction. 7. pleural thickening with trapped lung.

Keywords: talc -pleurodesis-bleomycin
adjunctive benefit of electrolytic cleaning on non-surgical treatment of peri-implantitis.

Conditions: Peri-Implantitis

Summary: evaluate the outcomes of non-surgical therapy of peri-implantitis with the adjunctive use of electrolytic cleaning (galvo surge®). the proposed protocol, focused on the non-surgical treatment of peri-implantitis, will result in a higher percentage of subjects with disease resolution (probing depts ≤ 5mm, absence of bop and/or sop and no further bone loss) at 1 year of follow-up.

the adjunctive use of electrolytic cleaning (galvo surge®) in the non-surgical treatment of peri-implantitis will result in a higher reduction of probing depth than the control group. the adjunctive use of electrolytic cleaning (galvo surge®) in the non-surgical treatment of peri-implantitis will result in a higher radiographic bone fill of the peri-implant defect than the control group. the adjunctive use of electrolytic cleaning (galvo surge®) in the non-surgical treatment of peri-implantitis will result in a lower count of peri-implant pathogens than the control group.

Eligibility criteria:
inclusion criteria: 1. partially edentulous patients, rehabilitated with at least one dental implant in the maxilla or mandible; 2. presence of peri-implantitis; 3. no implant mobility; 4. treated periodontal disease; 5. no systemic diseases that could influence the outcome of the therapy (i.e. uncontrolled diabetes, osteoporosis, bisphosphonate medication). 6. non-smoker or light smoking status in smokers (\<10 cigarettes/day). exclusion criteria: (1) pregnant, lactating women and non-collaborating patients will be excluded from the study.

Keywords: treatment of peri-implantitis electrolytic cleaning