Kornimate/medical-research-clean huggingface dataset:
trial of pemetrexed in combined with cisplatin for the treatment of advanced breast cancer

Conditions: Locally Advanced Malignant Neoplasm

Summary: for patients resistant to enthrycycline and taxanes, there is no standard regimen. pemetrexed alone had certain efficacy in treatment of advance breast cancer. platin was also a effective drug for advanced breast cancer. the combination of these two drug may have a synergy with each other in treatment of advanced breast cancer.

combination of pemetrexed and cisplatin to treat advanced breast cancer. previous regimen no more than 3 which including enthrycycline and taxanes(paclitaxel and/or docetaxel)

Eligibility criteria:
inclusion criteria: * 18-70 years old * resistant to enthracycle and taxanes * has measurable disease exclusion criteria: * has more than 3 previous chemotherapy regimens

Keywords: progress free survival response rate safety
hemorrhoidectomy with or without lateral internal sphincterotomy in management of patients with hemorrhoids

Conditions: Lateral Internal Sphincterotomy; Hemorrhoidectomy; Hemorrhoids

Summary: this study aims to compare the lateral internal sphincterotomy versus no lateral internal sphincterotomy during hemorrhoidectomy in the management of patients with hemorrhoids.

hemorrhoidectomy is associated with postoperative pain, and no single surgical technique has been proven to reduce the pain significantly. however, there are many drawbacks to such techniques, such as postoperative pain and constipation. the cause of this postoperative pain is multifactorial. spasm of the internal anal sphincter (ias) is one of the factors which is exposed and impinged after eh. therefore, lateral internal sphincterotomy (lis) is a widely used adjunct treatment after eh, which can abolish spasms of the ias and subsequently relieve postoperative pain.

Eligibility criteria:
inclusion criteria: * age above 18 years old. * both sexes. * all patients indicated for surgical hemorrhoidectomy (2nd, 3rd, and 4th degree piles). exclusion criteria: * patients with 1st degree piles. * patients with piles plus fissure. * age above 70 years old * unfit for surgery.
efficacy of spanish or english language versions of mindfulness meditation on depression

Conditions: Depression

Summary: this study explores the differential efficacy of spanish or english versions of a mindfulness intervention on depression levels, using a pre test post test design and an active control condition (health education).

this study is a randomized controlled trial (rct) with an experimental condition (maps mindfulness intervention) and an active control group (health education), using a pretest and immediate posttest research design. both conditions are comprised of a 6-week group intervention, which will be administered at the ucla westwood medical campus. the sample (n=80) will be drawn from a population of adults (18-65 years old), residing within a 10mile radius of the ucla westwood medical campus. to determine initial eligibility, potential participants will self-select based on perceived high levels of stress. participants will respond self-report questionnaires to assess for psychological symptoms and will be drawn blood samples (180ml total) to assess levels of pro inflammatory cytokines before and after the interventions. participants will attend a total of 8 visits.

Eligibility criteria:
inclusion criteria: * in order to determine eligibility, interested participants will be phone screened. to qualify for the study, participants have to be fluent in either spanish or english, validated by self-report at phone screening. additionally, during the phone screening participants had to complete a 4-item version of the perceived stress scale (cohen \& williamson, 1988) and score above the 50th percentile (a score of 9 or higher) in order to be eligible exclusion criteria: * people not meeting any of the above criteria.

Keywords: mindfulness depression spanish
a study of leukocytapheresis (lcap) in patients with ulcerative colitis (uc)

Conditions: Ulcerative Colitis

Summary: this is a prospective, randomized, double-blind, sham treatment controlled multicenter study.


Eligibility criteria:
inclusion criteria: * patients diagnosed to have uc in the active stage based on clinical symptoms and findings from endoscopy * patients with pancolitis type or left-sided colitis type lesion of 15 cm or longer observed endoscopically * patients with mayo score between 5 and 10 * patients with mayo sub-score (findings from flexible sigmoidoscopy) of 2 or 3 * patients not having received any corticosteroids (referred to as steroids) (p.o., i.v., enema, suppository) within the past 6 weeks exclusion criteria: * patients with a difficulty in peripheral vascular access * patients having received ace inhibitor (at least 10 times of its half-life time for interval needed before initiating the treatment) * patients with toxic megacolon * patients with a malignant disease or its experience * patients with a severe cardiovascular disease (grade iii or iv by the classification of heart functions of the new york heart association (nyha)) * patients with a liver or kidney disease (ast(got) or alt(gpt) or total bilirubin or creatinine level which is 2 or more times higher than the upper limit of normal (abbreviated as uln, hereinafter) * patients suspected to have or having hbv or hcv or hiv or pathogenic bacteria * patients on anticoagulant therapy or with abnormality in the blood coagulation system (pt or ptt levels which are 1.5 or more times higher than uln * pregnant women or patients with possible pregnancy * breast feeding women * patients weighing 40 kg or less * patients with hemoglobin level of less than 6.5 mmol/l (10.5 g/dl) * patients with platelet count of less than 150 x 103/mm3, 150 x 109/l (15 x 104/mm3) * patients with white blood cell count of less than 3.5 x 109/l (3,500/mm3) * patients with hypotension (with systolic blood pressure of 80 mmhg or less)

Keywords: cellsorba ex
study of humax-cd20, a new drug to treat early stage non-hodgkin´s follicular lymphoma

Conditions: Lymphoma, Follicular

Summary: the purpose of this trial is to determine the safety and efficacy of humax-cd20 as a treatment for follicular lymphoma (fl).


Eligibility criteria:
inclusion criteria: * relapsed or refractory follicular lymphoma grade i-ii * tumor verified to be cd20 positive * ct scan showing demarcated lesions exclusion criteria: * previous treatment with rituximab resulting in less than partial response * previous radioimmunotherapy * previous stem cell transplantation * received the following treatments within 4 weeks prior to entering this study: 1. anti-cancer therapy 2. glucocorticosteroids unless less than 10 mg prednisolone/day 3. radiotherapy * received mitomycin c or nitrosoureas within 6 weeks prior to entering this trial * hiv positivity * hepatitis b or hepatitis c * uncontrolled or chronic bacterial, fungal or viral infection * other cancer diseases, except certain skin cancers, cervix cancer and breast cancer * certain serious medical conditions, including kidney or liver disease, some psychiatric illnesses, and stomach, lung, heart, hormonal, nerve or blood diseases * who performance status of 3 or 4 * if you are participating in another trial with a different new drug 4 weeks before you enter this trial * current participation in any other clinical study * pregnant or breast-feeding women * women of childbearing age who are unable or unwilling to use an iud or hormonal birth control during the whole trial

Keywords: follicular lymphoma non hodgkin´s lymphoma
processed amniotic fluid (paf) for the treatment of chronic wounds

Conditions: Wounds and Injuries

Summary: a prospective randomized controlled study to determine the safety and feasibility of using processed amniotic fluid (paf) to expedite healing in chronic wounds.

the goal of our study is to assess, in an outpatient setting, the safety and the time to wound closure in chronic wounds treated with processed amniotic fluid (paf). we will include patients with lower extremity full thickness wounds that are greater than 3 months old and less than 12 months old. the wound size must be greater than 5cm2 and less than 75 cm2. we will exclude anyone that requires skin grafting, or wounds with sinus tracts. our primary objective is to determine the safety and feasibility of using paf to treat patients with chronic wounds. the secondary objective is to determine the efficacy of paf compared to standard of care in reducing wound area.

Eligibility criteria:
inclusion criteria: 1. patients 18-85 years old. 2. patients with chronic lower extremity wounds (including thermal) that are greater than 3 months, but less than 12 months old. 3. patients with full thickness wounds. 4. patients with at least one wound that is ≥5 cm2 and\<75 cm2 in size. 5. patient who is able to complete required site study visits and procedures in good faith exclusion criteria: 1. patients admitted to the hospital at the time of enrollment. 2. patients who are pregnant, nursing or plan to become pregnant while participating in the study. if of child-bearing potential, unwillingness to use effective birth control while participating in the study. 3. suspicion of or diagnosis of osteomyelitis underlying the wound. 4. patients who have received an investigational agent or intervention within the prior 30 days or plan to use within the study period. 5. patient with sinus tracts, enterocutaneous fistulas or other epithelialized tracts. 6. patients who require skin grafting. 7. patients diagnosed with a highly disruptive, non-controlled mental health disorder (e.g.., bipolar, or schizophrenia. 8. patients with a history of prior drug abuse.

Keywords: chronic wounds
an observational outcomes study for autologous cell therapy among patients with copd and interstitial lung disease

Conditions: COPD; Interstitial Lung Disease

Summary: the purpose of the lung institute is to collect and isolate a patient's own cells and platelet rich plasma (prp) and deliver the product back to the patient same-day. lung institute's treatment is limited to self- funded patients with chronic lung disease - chronic obstructive pulmonary disease (copd) and interstitial lung disease (ild). the patient's cells and platelet rich plasma are collected through venous harvesting. the hypothesized outcomes of lung institute therapy are safety and minimization of adverse events, a perceived improvement in the patient's lung condition (to be determined by their ability to be more physically active; walking greater distances with or without oxygen and improved quality of life scales), an improvement in the fev1 among copd patients, the ability to reduce their use of oxygen and possibly to stop it., the ability to function well without the use of rescue inhalers, reduction or ceasing of secondary pulmonary infections, reduction in emergency room visits and exacerbations related to their disease.

through the collection of outcome data, lung institute aims to explore and describe the safety and efficacy of autologous cellular therapy for chronic lung disease with dissemination to the public and to the medical community for the advancement of regenerative medicine. the study aims to confirm the safety of autologous cell therapy, explore the effect of autologous cell therapy treatment on pulmonary function, and to describe the anecdotal quality of life changes of patients following treatment using both quantitative and qualitative measures.

Eligibility criteria:
inclusion criteria: * patients are included in treatment by self-referral and after consultation with a designated patient coordinator, who determines initial eligibility, and then by the nurse practitioner or physician of the lung institute who determines final eligibility for treatment. all eligible and thereby traded patients are eligible for the study exclusion criteria: * patients who are unable to provide informed consent, pregnant patients, prisoners, non-english speakers, patients with a history of cancer within the past 5 years, patients with active tuberculosis or pneumonia. in addition, patients on prescribed blood thinners, with a history of breast or prostate cancer of any time frame or with a history of osteoporosis are excluded from the bone marrow harvest option.

Keywords: shortness of breath breathlessness cellular therapy platelet rich plasma quality of life pulmonary function
prisma study (prospective, randomized trial on intensive self-monitoring blood glucose management added value in non-insulin treated type 2 diabetes mellitus patients)

Conditions: Diabetes Mellitus Type 2

Summary: this randomized, parallel study compares 2 groups of type 2 non-insulin treated (nit) diabetes patients using the accu-chek aviva glucometers. one group (intensive group) will perform a 4-point daily glucose monitoring profile 3 times a week monnier-based. these patients will also receive specific glycemic targets and suggestions on how to reach them following lifestyle recommendations. at the same time, investigators will use smbg results, downloaded from glucometers, to improve patients' therapy. the second group (control group), will follow the smbg standard care usually adopted in their centers. to be eligible, patients do not to have performed a previous intensive smbg management (the execution of smbg measurements used to modify lifestyle, diet or physical activity, in a systematic/structured manner and/or to manage therapeutic approach). the anticipated duration of the trial is 12 months, and the target sample size is 1000 individuals.


Eligibility criteria:
inclusion criteria: * adult patients, 35-75 years of age * non-insulin treated type 2 diabetes for 1-10 years before enrollment * treatment with diet and oral hypoglycemic agents, or with diet only * hbalc of 7.0-9.0% exclusion criteria: * type 1 diabetes * insulin treatment (for \&gt;7 consecutive days) * previous intensive smbg management (the execution of smbg measurements used to modify lifestyle, diet or physical activity in a systemic/structured manner and/or to manage therapeutic approach) * impending complications of diabetes; * serious diseases, including cardiovascular damage or limited life expectancy; * pregnancy
tuned versus untuned ankle-foot orthoses in children and adolescents with cerebral palsy

Conditions: Cerebral Palsy

Summary: cerebral palsy (cp) in children and adolescents is frequently accompanied by gait abnormalities. ankle-foot orthoses (afo) have been suggested to improve the gait pattern. compared to conventional afo, modular afo offer the opportunity to tune its response to the patient's gait characteristics and/or functional maturity. however, the evidence level is still small and afo tuning is not yet established in clinical routine. the study will investigate individual tuning of custom-built ankle-foot-orthoses (afo) using gait analyses


Eligibility criteria:
inclusion criteria: * patients in outpatient treatment from the university children's hospital basel (ukbb) * informed consent provided as documented by signature * confirmed diagnosis of cerebral palsy * confirmed diagnosis of spastic equinus and/ or drop foot, * gait pathologies treated with conventional afo * gross motor function classification system (gmfcs) level i or ii exclusion criteria: * other neuromuscular diseases * previous surgical treatment to improve gait pathologies * injections of botulinum toxin 6 month prior to study inclusion * inability or unwillingness to follow the procedures of the gait analysis
neurobehavioral mechanisms of choice in opioid use disorder

Conditions: Opioid Use Disorder

Summary: the objective of this protocol is to use probabilistic reinforcement learning choice tasks and magnetic resonance neuroimaging to demonstrate the impact of problematic opioid use and opioid withdrawal on dynamic decision-making and reveal the neurobehavioral and neurobiological processes underlying abnormal task performance. a second objective is to identify an appropriate dose of intravenous remifentanil for subsequent studies in physically dependent individuals with opioid use disorder.


Eligibility criteria:
inclusion criteria: * must meet moderate/severe criteria for moderate/severe opioid use disorder, report recent prescription or illicit opioid use, and be opioid dependent, as evidenced by either a urine sample positive for recent opioid use or being in frank withdrawal during screening. * female subjects must be using an effective form of birth control (e.g., birth control pills, surgical sterilization, iud, cervical cap with a spermicide, or abstinence). * able to speak and read english * subjects who are interested in completing the remifentanil dose-ranging session must report a history of intravenous opioid use and a baseline o2 saturation of 95% or greater. exclusion criteria: * history of, or current, clinically significant physical disease (e.g., respiratory disease \[asthma, copd, sleep apnea\], impaired cardiovascular functioning, seizure disorder or cns tumors) or current or past history of psychiatric disorder that would limit compliance in the studies, other than substance use disorder. * meet diagnostic criteria for psychoactive substance use disorder for substances other than opioids (oud subjects only) or nicotine that would require detoxification (i.e., alcohol, benzodiazepines or barbiturates). * contraindications for mri scanning (e.g., pacemaker, metal implants, claustrophobia, or any other implanted medical device). * vision or hearing problems that would preclude completion of experimental tasks. * at risk for respiratory complications and have predictors of difficult bag mask ventilation (e.g., dentures, very full beard), in case emergency respiratory intervention is needed. * seeking treatment for sud. * poor venous access (only subjects who will participate in the remifentanil dose-ranging session).
external phase mri in diagnosis of oasi

Conditions: Anal Sphincter Injury; Obstetrics Trauma

Summary: there is around 60 000 births annually in finland. around 1-5% of all vaginal deliveries in finland complicate in a grade iii- iv perineal tear. because the diagnosis of a sphincter lesion after birth can be challenging the total amount of women having obtained a sphincter lesion could be even grater. the aim of our study is to compare different tools in the diagnosis of obstetric anal sphincter injury. in doing so the investigators hope to achieve early diagnosis of this pathology and thus facilitate early treatment of a possible sphincter defect.

see the attacher research plan for a more detailed description

Eligibility criteria:
inclusion criteria: women with oasi exclusion criteria: under 18

Keywords: oasi faecal incontinence obstetric anal sphincter injury mri
anemia of inflammation: investigation on impaired iron regulation in acutely ill patients and their clinical outcome

Conditions: Anemia of Acute Inflammation

Summary: anemia of inflammation (ai), a normochromic, normocytic anemia, associated with abnormal iron utilization, erythropoietin hyporesponsiveness, and decreased red blood cells (rbc) survival is a very common problem in hospitalized patients for acute inflammatory diseases and develops within few days from the onset of illness. deleterious effects of anemia include increased risk of cardiac related morbidity and mortality in critically ill and older patients. anemia is mediated by hepcidin, the 25-amino acid polypeptide hormone that is central to iron trafficking. several studies have been performed on pathophysiology of ai in patients affected by chronic diseases but few explore iron metabolism in humans with acute inflammation. the aim is to develop effective new strategies to detect and manage ai in the setting of acutely ill patients, based on the understanding of iron balance underlying this disorder.


Eligibility criteria:
inclusion criteria (both): * serum c-reactive protein level \> 3mg/dl * creatinine level \ 30%) exclusion criteria: * any haematological diseases * cancer under chemotherapy * aids (or hiv+) * liver cirrhosis * genetic hemochromatosis * immunosuppressive therapy * blood transfusion in the past 30-days

Keywords: hepcidin anemia acute inflammation il-6 cytokines
procleix® dengue virus assay testing of individual donor samples from puerto rican blood donors - american red cross

Conditions: Dengue

Summary: the objective of this study is to test individual donor samples (idss) with the investigational dengue assay on the tigris system and to further characterize the dengue assay in the clinical setting.


Eligibility criteria:
inclusion criteria: * donor must meet all the blood collection sites' standard eligibility requirements. * donor and/or legally authorized representative must be willing to undergo the site's routine informed consent process prior to study participation.
safety and efficacy of hydroxychloroquine for the treatment & prevention of coronavirus disease 2019 (covid-19) caused by severe acute respiratory syndrome coronavirus 2 (sars-cov-2)

Conditions: Covid19; SARS (Severe Acute Respiratory Syndrome)

Summary: coronavirus disease 2019 (covid-19) (previously called 2019-ncov acute respiratory disease) is caused by sars-cov-2, a positive-sense single-stranded rna virus of the coronavirus family. the coronaviruses are largely responsible for the common cold, the 2002 sars outbreak in guangdong, china, the 2012 mers outbreak in saudi arabia, and the present covid-19 outbreak that originated in wuhan, china. much has been reported by way of systemic injury caused by covid-19 affecting the cardiovascular, hepatic, nervous systems. these conditions are likely the result of the virus overwhelming the immune system. for these reasons, the investigators wish to conduct this study using existing medications off-label, and over-the-counter supplements to support the immune response, prevent lasting injury, and hasten the recovery from covid-19.


Eligibility criteria:
inclusion criteria: 1) patients must have one or more of the following: 1. confirmed diagnosis of active sars-cov-2 infection, diagnosed with pcr 2. continued close contact with an individual with suspected sars-cov-2 infection 3. at risk for sars-cov-2 infection in the opinion of the treating physician or principal investigator. exclusion criteria: 1) patients must not have any uncontrolled disease such as: 1. cardiovascular disease 2. hepatic disease 3. renal disease 4. metabolic disease 5. other diseases or insufficiencies
safety and efficacy of maraviroc in patients for hiv patients (regulatory post marketing commitment plan)

Conditions: CCR5-tropic HIV-1 Infection

Summary: the objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the lpd (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.

all the patients whom an investigator prescribes the first celsentri® tablets should be registered consecutively until the number of subjects reaches target number in order to extract patients enrolled into the investigation at random.

Eligibility criteria:
inclusion criteria: patients need to be administered celsentri® tablets in order to be enrolled in the surveillance. exclusion criteria: patients not administered celsentri® tablets.