Kornimate/medical-research-clean huggingface dataset:
bevacizumab plus mfolfoxiri as first-line treatment for patients with unresectable metastatic colorectal cancer

Conditions: Colorectal Cancer

Summary: the current clinical trials and data on the triplet regimen combined with bevacizumab for first-line treatment of metastatic colorectal cancer were from european and american populations. the triplet regimens recommended by the nccn and esmo guidelines using irinotecan and 5-fu at a higher dose intensity cause a high incidence of adverse events in asian population, and there was no high-quality data on efficacy in chinese population, both of which have limited the clinical applications of the regimens in china. this study intends to conduct an improved triplet regimen (mfolfoxiri) combined with bevacizumab versus mfolfox6 combined with bevacizumab as a first-line multicenter, randomized, controlled phase iii clinical trial in patients with advanced colorectal cancer. progression-free survival (pfs), observable response rate (orr), overall survival (os), disease control rate (dcr), surgical resection rate, and safety and health-related quality of life (hrqol) were assessed in the two groups of subjects.


Eligibility criteria:
inclusion criteria: - histological or cytological documentation of adenocarcinoma of the colon or rectum. all other histological types are excluded. subjects with metastatic colorectal cancer(crc) (stage iv). subjects treated with oxaliplatin in an adjuvant setting should have progressed during or within 12 months of completion of adjuvant therapy. subjects who have withdrawn from standard treatment due to unacceptable toxicity warranting discontinuation of treatment and precluding retreatment with the same agent prior to progression of disease will also be allowed into the study. metastatic crc subjects must have measurable or non measurable disease according to response evaluation criteria in solid tumors (recist) criteria, version 1.1. eastern cooperative oncology group (ecog) performance status of 0 or 1. adequate bone marrow, liver and renal function as assessed by the laboratory required by protocol. exclusion criteria: - previous or concurrent cancer that is distinct in primary site or histology from colon cancer within 5 years prior to randomization. significant cardiovascular disease including unstable angina or myocardial infarction within 6 months before initiating study treatment. heart failure grade iii/iv (nyha-classification). unresolved toxicity higher than ctcae v.4.0 grade 1 attributed to any prior therapy/procedure. subjects with known allergy to the study drugs or to any of its excipients. current or recent (within 4 weeks prior to starting study treatment) treatment of another investigational drug or participation in another investigational study. breast- feeding or pregnant women lack of effective contraception.
functional electrical stimulation in irradiated nasopharyngeal carcinoma (npc)

Conditions: Dysphagia

Summary: the purpose of this study is to determine whether functional electrical stimulation is effective in the treatment of dysphagia due to nasopharyngeal cancer post radiotherapy

nasopharyngeal carcinoma (npc) patients usually underwent radiotherapy (rt) or chemoradiotherapy(crt). there were some complications caused by rt, like dysphagia. in recent studies, functional electrical stimulation (fes) was be used in neurologically dysphagia patients, and there were some positive effects with these studies. hence, we decided applied fes to these npc patients with dysphagia.

Eligibility criteria:
inclusion criteria: * primary nasopharyngeal carcinoma * post radiation therapy * mild to severe dysphagia * never underwent swallowing therapy exclusion criteria: * recurrent cancer * neurological or degenerate disease * total or partial laryngectomy * epilepsy * with cardiac pacemaker

Keywords: nasopharyngeal carcinoma functional electrical stimulation
trial of antimicrobial restraint in presumed pneumonia

Conditions: Healthcare-Associated Pneumonia; Sepsis

Summary: the objective of this cluster-randomized crossover study is to determine the effect of delaying antimicrobial initiation until objective microbiologic data is obtained in patients with presumed icu-acquired pneumonia without septic shock.

this study will involve 8 centers is to determine the effect of delaying antimicrobial initiation until objective microbiologic data is obtained in patients with presumed icu-acquired pneumonia without septic shock. the study team will compare two sequential 4-month periods in each unit, one 'aggressive' antimicrobial initiation period and one 'conservative' antimicrobial initiation period. this study will serve the following specific aims: specific aim 1: to determine feasibility of a larger multicenter study of the same design as well as assess protocol adherence across multiple centers. specific aim 2: prospectively determine the all-cause, in-hospital mortality for all patients with suspected pneumonia who were treated under either an aggressive or conservative antimicrobial initiation protocol. specific aim 3: prospectively determine antimicrobial initiation rates, total days of antimicrobial administration, hospital and icu length of stay, and ventilator-free alive days for patients treated under each protocol. specific aim 4: to survey physicians that participated in the study to assess their feelings about the study including level of comfort starting antimicrobials aggressively, level of comfort withholding antimicrobials until definitive evidence of infection, perceived protocol adherence, perceived importance of the study, and willingness to participate in other studies of its kind (to be performed after closure of the clinical portion of the study).

Eligibility criteria:
inclusion criteria: * intubated patients admitted to a surgical or trauma intensive care unit that have had an appropriate quantitative or semi-quantitative endobronchial sputum culture sent ≥48 hours into their icu admission * primary pathology managed by surgical specialty * age ≥18 years. exclusion criteria: * non-intubated patients. * intubated patients with concern for active infection that is not suspected to be pneumonia (i.e. intra-abdominal infection, skin and soft tissue infection, urinary tract infection, etc.) * primary disease not surgical or traumatic in nature * primary diagnosis of burns * incarcerated status * pregnant status or delivery during this hospitalization. * on active immunosuppressive medications (or taking as a home medication prior to arrival)
pilot study comparing two versions of group cognitive-behavioral indicated prevention programs

Conditions: Depressive Symptoms

Summary: the purpose of this study is to compare the effectiveness of two depression prevention programs and a control brochure for college students. participants may experience reductions in depressive symptoms and prevention of future depression.


Eligibility criteria:
inclusion criteria: * current student at the university of oregon * subthreshold symptoms of depression, as indicated by a ces-d depression screener score of 20 or greater exclusion criteria: * current diagnosis of major depression * acute suicidal ideation requiring immediate mental health treatment
a multicenter extension study of taliglucerase alfa in adult subjects with gaucher disease

Conditions: Gaucher Disease

Summary: this is a multi-center trial to further extend the assessment of the safety and efficacy of taliglucerase alfa in adult subjects (≥18 years old) with gaucher disease who have enrolled in protocol pb-06-003. subjects will continue to receive an intravenous (iv) infusion of taliglucerase alfa every two weeks. the duration of treatment will be a maximum of 21 months or until taliglucerase alfa is commercially available to the subject at the discretion of the sponsor.


Eligibility criteria:
inclusion criteria: * successfully completed protocol pb-06-001 and enrolled in protocol pb-06-003 * the subject signs an informed consent exclusion criteria: * currently taking another investigational drug for any condition. * presence of any medical, emotional, behavioral or psychological condition that in the judgment of the investigator would interfere with the subject's compliance with the requirements of the study.

Keywords: enzyme replacement therapy
the medtronic harmony™ transcatheter pulmonary valve clinical study

Conditions: Congenital Heart Disease; Tetrology of Fallot; RVOT Anomaly; Pulmonary Regurgitation

Summary: the purpose of this study is to further evaluate the safety and effectiveness of the harmony™ tpv system. the pivotal/cas phases of the study have transitioned into a post-approval study to confirm the long-term functionality of transcatheter implantation of the medtronic harmony tpv.

the continued clinical experience addendum is a prospective, multi-center, non-randomized, interventional study to evaluate the safety and effectiveness of the harmony tpv system. all implanted subjects will receive the harmony tpv 22 or harmony mtpv 25 device. this phase allows up to 45 subjects implanted with tpv 22 in the united states and canada, and up to 84 subjects implanted with mtpv 25 in the united states. the post approval phase (pas) addendum is a prospective, multi-center, non-randomized, post-market study to evaluate the safety and effectiveness of the harmony tpv system in the united states. all implanted subjects have been implanted with the harmony tpv 22 or harmony mtpv 25 device during the pivotal or cas phase of the study. the pas addendum extends follow-up from five years to ten years for consenting subjects.

Eligibility criteria:
inclusion criteria: * subject has severe pulmonary regurgitation as assessed via echocardiography or cmr determined pr fraction \>/= 30% * subject has clinical indication for surgical placement of an rv-pa conduit or bioprosthetic pulmonary valve * subject is willing to consent to participate exclusion criteria: * patients with right ventricular outflow tract obstruction (rvoto) lesions surgically treated with an rv-to-pa conduit implant * rvot anatomy or morphology that is unfavorable for device anchoring * positive pregnancy test * life expectancy of less than 1 year
tranpas - treating anorexia nervosa plus autism spectrum

Conditions: Anorexia Nervosa; Autism Spectrum Disorder

Summary: in a pilot study, the investigators will validate a so-called autism care location in an inpatient ward. the care location will be adapted for patients with anorexia nervosa (an) and concurrent autism (an+autism). in order to investigate the effect of a tailored care location for patients with an + autism, the evaluation will include weight development and changes in nutritional intake, eating disorder and anxiety symptoms. the overall aim is to improve treatment for this specific an subgroup, that otherwise has a worse prognosis regarding an recovery.

anorexia nervosa (an) is a serious eating disorder and has the highest mortality rate of all psychiatric illnesses. adolescence is the most common age of onset. nine out of ten people who fall ill are girls/women, and 2% of all girls/women will fall ill with an at some point in their lives. in an, one engages in self-starvation, which in turn leads to underweight. 75 - 80% of individuals with an recover during adolescence, while the remainder are at high risk of developing chronic an. for the individual, the chronic condition means great suffering in the form of serious psychiatric and somatic co-morbidity, social isolation and reduced/lack of work ability. people with autism show social withdrawal and reduced flexibility, reminiscent of the symptoms seen in an. an estimated 15 - 20% of all individuals with an also have autism. people with an and concurrent autism run an increased risk of a worse prognosis, as they have more difficulty absorbing treatment, which in itself increases the risk of the condition becoming chronic. today, there is no scientific evidence for how people with an and concurrent autism should be treated. in a pilot study, the investigators will validate a so-called autism care location in our inpatient ward, at sahlgrenska university hospital in gothenburg, sweden. the care location will be adapted for patients with an and concurrent autism (an+autism). in order to investigate the effect of a tailored care location for patients with an + autism, the evaluation will include weight development and changes in nutritional intake, eating disorder and anxiety symptoms. the overall aim is to improve treatment for this specific an subgroup, that otherwise has a worse prognosis regarding an recovery.

Eligibility criteria:
inclusion criteria: * 25 years or older * meeting criteria for both anorexia nervosa and autism spectrum disorder according to the dsm-5 * in need of inpatient care due to anorexia nervosa exclusion criteria: * 24 years or younger * not in need of inpatient care due to anorexia nervosa * not meeting criteria for both anorexia nervosa and autism spectrum disorder according to the dsm-5

Keywords: anorexia nervosa autism pilot study validation
an extension study of abbv-8e12 in early alzheimer's disease (ad)

Conditions: Alzheimer's Disease

Summary: the purpose of this study is to assess the long-term safety and tolerability of abbv-8e12 in participants with early ad.


Eligibility criteria:
inclusion criteria: * all subjects with early ad who complete study m15-566 (nct02880956), meet all inclusion criteria, and do not meet any exclusion criteria are eligible for enrollment * subject was compliant during participation in study m15-566 (nct02880956) * subject has an identified, reliable study partner who has frequent contact with the subject and who will provide information as to the subject's cognitive and functional abilities exclusion criteria: * the subject has any significant change in his/her medical condition since participation in study m15-566 (nct02880956) that could interfere with the subject's participation in study m15-570, could place the subject at increased risk, or could confound interpretation of study results * more than 8 weeks have elapsed since the subject received his/her last dose of study drug in study m15-566 (nct02880956) * the subject is concurrently enrolled in another interventional clinical study involving a therapeutic agent with the exception of study m15-566 (nct02880956)
effect of pumpkin seed oil on hair growth in men with androgenetic alopecia

Conditions: Androgenic Alopecia

Summary: androgenic alopecia is the most common cause of hair loss in men. finasteride and minoxidil are available in treatment of androgenetic alopecia, although the former causes decreased libido or ejaculate volume, erectile dysfunction, the latter causes scaling, itching of the scalp. recently, pulpkin seed oil shows some improved clinical efficacy on scalp hair growth in men with androgenetic alopecia, but there is no evidence to support this. the investigators conducted a randomized, double-blind, placebo-controlled efficacy and tolerability trial of pumpkin seed oil (400mg/day)therapy in male patients with androgenetic alopecia.


Eligibility criteria:
inclusion criteria: * 18 to 65 years of age * androgenetic alopecia of norwood-hamilton scale grade ii-v exclusion criteria: * severe medical problems including renal problems, prostate diseases, diabetes mellitus o * patients who took any medicine which can affect the hair growth in recent 3 months.

Keywords: pumpkin seed oil hair growth men
the efficacy of precision treatment for gastric cancer guided by molecular profiling

Conditions: Gastric Cancer

Summary: gastric cancer (gc) is one of the most common and lethal cancers worldwide, especially in china, and the median overall survival for patients with advanced, metastatic gc remains only about 1 year. several molecular profiling studies have demonstrated that a proportion of gastric cancer harbour actionable molecular alterations which shows a predictive benefit from a specific therapy (in any cancer type). in the current study, the efficacy of precision treatment for gastric cancer guided by multidimensional molecular biology profiling will be observed. the analysis focused on the overall survival outcomes for patients whose tumours harboured actionable molecular alterations and who received appropriately matched therapy.


Eligibility criteria:
inclusion criteria: 1. male or female. age: 18-80 years. 2. histologically confirmed adenocarcinoma of the stomach or gastro-esophageal junction with inoperable locally advanced or recurrent and/or metastatic disease, not amenable to curative therapy. 3. measurable disease, according to the response evaluation criteria in solid tumors (recist) version 1.1, assessed using imaging techniques (ct or mri). 4. multidimensional molecular biology profiling has been conducted using tumor or blood sample. 5. ecog performance status 0-1. 6. life expectancy of at least 3 months. 7. signed informed consent. exclusion criteria: 1. the quality of ngs reports does not fit the requirement. 2. history of documented congestive heart failure; angina pectoris requiring medication; evidence of transmural myocardial infarction on ecg; poorly controlled hypertension (systolic bp \> 180 mmhg or diastolic bp \> 100 mmhg); clinically significant valvular heart disease; or high risk uncontrollable arrhythmias. 3. baseline lvef \< 50% (measured by echocardiography or muga). 4. patients with dyspnea at rest due to complications of advanced malignancy or other disease, or who require supportive oxygen therapy. 5. patients receiving chronic or high dose corticosteroid therapy. (inhaled steroids and short courses of oral steroids for anti-emesis or as an appetite stimulant are allowed). 6. known dihydropyrimidine dehydrogenase (dpd) deficiency. 7. history or clinical evidence of brain metastases. 8. serious uncontrolled systemic intercurrent illness, e.g. infections or poorly controlled diabetes. 9. positive serum pregnancy test in women of childbearing potential. 10. subjects with reproductive potential not willing to use an effective method of contraception. 11. major surgery within 4 weeks of start of study treatment, without complete recovery. 12. patients with known active infection with hiv, hbv, or hcv.

Keywords: gastric cancer precision medicine
robot-assisted and connected 6-minute walk test (tm6)

Conditions: Respiratory Insufficiency

Summary: evaluation of the reliability of the pepper robot in assisting and recording the parameters of a tm6. patients referred to the efred service for the performance of a 6mwt will be assisted during their test by the pepper robot. the pepper robot will also collect the parameters of the 6mwt and produce a report. the efred service technician will remain present during the 6mwt and will take note of the test parameters. an evaluation of patient satisfaction with the assistance of the robot pepper in the realization of the 6mwt will also be carried out.


Eligibility criteria:
inclusion criteria: * \>18 years * speak fluent french. exclusion criteria: * patient's refusal to participate in the study * language barrier * cognitive disorders.
the vertebral vector in a horizontal plane. a simple way to see in 3d.

Conditions: Scoliosis

Summary: the diagnosis and classification of scoliosis are almost exclusively based on frontal and lateral radiographs. current classifications of adolescent or adult idiopathic degenerative scoliosis are based only on the 2d approach. the classifications consider only the lateral deviation and the sagittal alignment and completely ignore all the changes (the axial vertebral rotation and the lateral translation etc ...) in the horizontal plane. the demand for an accurate assessment of the vertebral rotation in scoliosis is not new. biplane x-ray images provide insufficient quantitative or qualitative information on the anatomical landmarks needed to determine axial rotation. several measurement methods have been published, all of which are based on the evaluation of the relative positions of various posterior vertebral elements. the perdriolle torsiometer is currently the most accepted method in clinical practice, but its reproducibility is very limited and can not be quantified accurately.the horizontal plane deviations are more accurately evaluated by the ct scan, but the systematic use of this method is limited because of its relatively high cost and excessive radiation dose. expert opinion is also divided on the veracity and reproducibility of ct scan for such measurements. given the absence of a definitive and reproducible measurement method for 3d characterization of the vertebral columnar deformities, the investigators introduced the concept and system of vertebral vectors.the vertebral vector technique is currently the only technique in the world that allows the visualization of vertebral column deformities by analyzing each vertebral body and defining characteristic mathematical and geometric parameters that uniquely characterize each vertebrae. a new digital radioimaging technique based on a low dose x-ray detection technology simultaneously creates frontal and lateral whole body radiographic images captured in a standing position, which is the basis of visualization of the vertebral vector. to examine the two phenotypes of scoliosis, it is necessary to collect the radiological data specific to the disease. after generating the vertebral vectors and obtaining the three-dimensional coordinates, an analysis and an exact mathematical description will be performed. the projections of the curves in the three planes will also be analyzed, with particular attention to the projections in the horizontal planes. based on the mathematical models and the axial projection of the curves, a new three-dimensional classification can be imagined for the first time not only for adolescent scoliosis, but also for adult degenerative scoliosis. the main objective of this study is to develop new evidence-based treatments based on the unambiguous understanding of 3d features of vertebral columnar deformities.


Eligibility criteria:
inclusion criteria: patients with adolescent idiopathic scoliosis or adult degenerative scoliosis, treated or untreated, radiographed with the eos system exclusion criteria: none

Keywords: 3d imaging vertebral vector scoliosis
ovarian cancer and immune response to flu vaccine

Conditions: Ovarian Cancer

Summary: the purpose of this study is to determine what the immune response is of ovarian cancer patients in remission, when they are given the flu vaccine. after receiving the flu vaccine, patients will have blood drawn 5 times in 12 months to study antibody response to the flu vaccine.


Eligibility criteria:
inclusion criteria: * all subjects must have a histologic diagnosis of epithelial ovarian cancer or primary peritoneal carcinoma. time from completion of chemotherapy will be no more than 6 months. * if no clinical evidence of disease is present after diagnosis with stage iii or iv disease and completion of primary surgery and chemotherapy, or, if no clinical evidence of disease is present after completion of chemotherapy for a disease recurrence diagnosed after a progression-free interval of at least 2 years, for patients of any initial stage. exclusion criteria: * prior malignancy (except basal cell or squamous cell skin cancer) within the past five years. * presence of active cns disease. * active bacterial, viral or fungal infections. * chemotherapy, biologic therapy, or radiation therapy \< 4 weeks prior to study entry. * history of active autoimmunity or immunosuppression. * use of immunosuppressive drugs within 4 weeks prior to study entry. patients may receive chemotherapy or other immunosuppressive medications at the discretion of their physician during the subsequent year after influenza vaccination without exclusion from the study. * patients with tumors of low malignant potential (borderline tumors) will not be eligible. * prior influenza vaccination with the current vaccine. * history of serious sensitivity to eggs, or previous influenza vaccine. * pregnant of breastfeeding subjects.

Keywords: advanced ovarian and primary peritoneal cancer in remission