Kornimate/medical-research-clean huggingface dataset:
maternal hyperoxygenation in congenital heart disease

Conditions: Hypoplastic Left Heart Syndrome

Summary: a pilot study investigating the safety and feasibility of chronic maternal hyperoxygenation in the setting of fetal congenital heart disease

the aim of the study is to investigate the safety and feasibility of chronic maternal hyperoxygenation in pregnancies affected by fetal congenital heart disease, specifically those pregnancies in which the fetus has single ventricle physiology with aortic arch obstruction. the treatment has a potentially neuroprotective effect on the fetus. this would be desirable as the neurodevelopmental outcomes of the survivors of this form of congenital heart disease are significantly below normal. however, transplacental oxygen has not been tried in this setting, and so before embarking on a trial, the investigators need to establish that the treatment is safe and feasible. this will be accomplished by recruiting subjects which meet the eligibility criteria and commence treatment at the time of diagnosis, usually in the second trimester, and by comparing outcomes with a historical cohort with chd diagnoses with no oxygen intervention. the oxygen will be delivered to the mother via nasal prongs continuously at a rate of up to 4 l/min. oxygen concentrators will be supplied to the subjects' homes, and a range of portable devices will also be provided to allow them to continue with usual activities of daily living. a series of follow up appointments will be arranged to check the status of the mother and fetus. mothers will be invited to keep a diary of their adherence to the treatment. a range of routine clinical and research data on the condition of the fetus and newborn will be collected.

Eligibility criteria:
inclusion criteria: * between 20-32 weeks gestation * diagnosis of fetus with a single ventricular ventricular heart * delivering at mount sinai hospital * written informed consent exclusion criteria: * opting for termination of pregnancy/ comfort care * normal exclusions for mri (e.g. claustrophobia, cardiac pacemaker, etc.) * bmi \>37.0 * infections/ anemia * smoker * serious cardiorespiratory co-morbidities
the effectiveness of local infiltration technique in adult tonsillectomy

Conditions: Post Operative Pain

Summary: tonsillectomy is commonly associated with postoperative pain. the modified pre-incision infiltration of anesthetic mixture combined with general anesthesia was shown to decrease post-tonsillectomy pain in children. hence, the present clinical trial will assess the effectiveness of this technique in adults undergoing tonsillectomy.

the study will be conducted prospectively, using a randomized double-blind design. adult patients scheduled for total or partial tonsillectomy with or without adenoidectomy starting from january 2019 till january 2020 will be included.patients will be allocated randomly into two equal groups using the sealed envelope method. both groups will receive general anesthesia. then, one group will receive pre-incision infiltration of 2.5 ml local anesthesia mixture in each tonsil. the second group will have placebo infiltration.

Eligibility criteria:
inclusion criteria: * patients with total or partial tonsillectomy with or without adenoidectomy exclusion criteria: * patients who took antiemetics, steroids, or antihistaminics within 24 hours before surgery. - patients who have asthma * patients who have diabetes * patients who have bleeding problems * patients who are suspected to have signs of acute pharyngeal infection
impact of immune challenge on triple network connectivity in humans

Conditions: Major Depression

Summary: acquiring, processing and utilising "information" is crucial to any mental function -including seemingly simple daily functions. collectively called 'cognitive functions', these processes are a result of different regions of the brain acting together. disruption of these cognitive functions increases the risk of development of mental health problem. recently it has been proposed that inflammatory pathways may contribute to disorders of cognition and behaviour like depression. this is largely due to research showing that those with inflammatory conditions like arthritis are more likely to develop mental health problems like depression. conversely, those who suffer from mental health problems (even in the absence of inflammatory conditions) have large amounts of inflammatory molecules in the blood. studies in animals suggest that inflammation outside the brain can reach and affect the brain in a number of ways. so, does inflammation play a role in the development of cognitive and behavioural symptoms? what are the pathways involved? the current project tries to address this question. specifically, the investigators intend to use modern scanning techniques to examine the effect of inducing a low grade inflammation (using a commonly used typhoid vaccine) to see how the inflammation affects how different regions of the act together to perform cognitive functions.


Eligibility criteria:
inclusion criteria: 1. written informed consent 2. aged 18 - 50 years old 3. male exclusion criteria: 1. female 2. history/family history of medical or/and axis i dsm iv condition 3. received typhoid vaccination within the last 3 years 4. taken oral antibiotics/antiinflammatory agents within the previous 2 weeks 5. current smokers 6. contraindication for mri scans 7. contraindication for salmonella typhi vaccination 8. known hypersensitivity to a vi antigen containing vaccine.
dexketoprofen and etoricoxib in patients undergoing hip arthroplasty

Conditions: Pain, Postoperative

Summary: the main purpose of this study was to determine the plasma and central nervious system pharmacokinetics of dexketoprofen and etoricoxib. the secondary aim was to asses their effect on the concentrations of interleukin 6, prostaglandin e2 and other proinflammatory markers both in plasma and cerebrospinal fluid. thirdly, the investigators aimed to evaluate their efficacy in postoperative pain treatment.


Eligibility criteria:
inclusion criteria: * agreed to participate the study * american society of anesthesiologist s physical status classification 1-3 * elective hip arthroplasty planned * no contraindications to the study drugs * no contraindication to lumbar puncture exclusion criteria: * refused to participate the study * age less than 40 or over 75 years * planned anesthesia method other than spinal anesthesia * contraindications to the study drugs * contraindications to lumbar puncture

Keywords: dexketoprofen etoricoxib hip arthroplasty pain
a pilot study of remote monitoring to improve health related quality of life of men following prostate cancer treatment.

Conditions: Health-Related Quality Of Life

Summary: the purpose of this study is to determine the feasibility of using digital technology and remote monitoring to track health-related measures in men following prostate cancer treatment. half of the participants will receive tools to monitor their activity and weight, as well as personalized feedback on these measures, while the other half will receive standard of care. health related quality of life measure will be collected from both groups.

the purpose of this study is to determine the feasibility of using digital technology and remote monitoring to track health-related measures in men following prostate cancer treatment. all participants will complete a health-related quality of life survey each month for 3 months. the digital survey will be administered on a programmed tablet. the participants in the intervention group will also receive an activity sensor and weight scale. health state data from this group will be generated over a 3-6 month period and remotely monitored. these data will be used to provide personalized feedback regarding the participant's progress towards established goals. health-related quality of life will be compared between participants in the intervention group, who receive (1) tools to monitor their activity and weight and (2) personalized feedback, versus participants in the control group, who receive standard of care. the potential improved adherence to healthy behaviors of the participants receiving personalized feedback may translate to to improved health-related quality of life.

Eligibility criteria:
inclusion criteria: * participants must have localized prostate cancer. * participants must have received treatment at johns hopkins * participants must be classified as overweight (body mass index ≥ 25). * participants must have wi-fi in their homes. exclusion criteria: * anyone who is unable to give informed consent will be excluded * anyone who is physically unable to participate in physical activity will be excluded.
expanded access to intrathecal administration of autologous mesenchymal stem cell-derived neural progenitors (msc-np) in progressive multiple sclerosis

Conditions: Multiple Sclerosis

Summary: to give expanded access to intrathecal autologous msc-np treatment to patients with progressive ms who do not meet the inclusion/exclusion criteria of our phase ii stem cell trial.


Eligibility criteria:
inclusion criteria: * diagnosis of ms as defined by the mcdonald criteria * diagnosis of primary progressive or secondary progressive ms * patients will be 18 years or older * significant disability shown by an expanded disability status score (edss, \[5\]) ≥4.5 that was not acquired within the last 12 months \*(patients with moderate to severe cerebellar dysfunction who have an edss of \<6.5 who are not eligible for our ph ii version date: 11/21/18 version #4 9 study will be included. this is because edss scores are heavily related to muscle strength and not balance or coordination and most accurately reflect paraparesis. also there are patients with ms who have disabling upper limb coordination dysfunction but edss scores of better than 6.5 who are not suitable for the phase ii study but may benefit from this therapy). * stable disease state as evidenced by a lack of gadolinium-enhancing lesions on an mri and by a stable mri disease burden (number of t2 lesions and size of lesions) in the last six months and no significant change in edss (1 point or more) in the last 12 months * does not qualify for the inclusion/exclusion criteria of our phase ii stem cell trial. for example, patients with edss \>6.5 or ms symptom onset and/or duration of disease \>15 years exclusion criteria: * all patients who have had any prior stem cell treatments, including hsct * pregnant or nursing mothers or any woman intending to become pregnant in the next three years * use of systemic chemotherapeutic or anti-mitotic medications within three months of study start date due to the possibility of interference with bone marrow procedure * history of central nervous system infection or immunodeficiency syndromes due to increased risk of cns infection * patients who are anticipated to have difficultly accessing the intrathecal space related to scoliosis, obesity, or any other relevant factors determined by the pi. * patients who have not tried available therapies for their progressive ms

Keywords: mesenchymal stem cells neural progenitors autologous bone marrow multiple sclerosis
clinical trial of gemcitabine and oxaliplatin in recurrent or metastatic breast cancer

Conditions: Recurrent Breast Cancer; Metastastic Breast Cancer

Summary: the purpose of this study is to find out if the combination of gemcitabine and oxaliplatin chemotherapy will be effective in reducing or eliminating the tumor(s) in patients with recurrent or metastatic breast cancer. gemcitabine is a chemotherapy drug approved by the u.s. food and drug administration (fda) for the treatment of pancreatic and lung cancer; oxaliplatin is a chemotherapy drug that is approved by the fda for the treatment of colon cancer. neither gemcitabine nor oxaliplatin are approved for the treatment of breast cancer. however, both drugs have been shown to decrease the size of breast cancer tumors.


Eligibility criteria:
inclusion criteria: * histologically proven dx of recurrent or metastatic breast cancer * must have received at least 1 but not more than 3 prior chemotherapy regimens for recurrent or metastatic breast cancer. patients who relapse within 12 months of completing adjuvant chemotherapy can only have had up to 2 prior regimens for metastatic disease. patients who relapse within 12 months of completing adjuvant chemotherapy containing an anthracycline and a taxane, do not require prior chemotherapy for metastatic disease. * unidimensionally measurable dz (by recist) * at least 18 yrs of age * swog ps 0-2 * agc greater than or equal to 1.5; platelets greater than or equal to 100,000; hgb greater than or equal to 8.0 * total bilirubin less than or equal to 2 x uln; sgot and/or sgpt and alk phos up to 2.5 x uln * creatinine less than or equal to 2.0 * fully recovered from acute toxicities secondary to prior tx * signed informed consent (including hipaa authorization) * peripheral neuropathy grade 0-1 exclusion criteria * prior tx with gemcitabine or oxaliplatin. prior tx with cisplatin or carboplatin allowed if completed \>12 mos prior to enrollment. * underlying medical, psychiatric, or social conditions that would preclude patient from receiving tx * peripheral neuropathy greater than or equal to gr 2 exclusion criteria: -
heart function in rheumatoid arthritis and ankylosing spondylitis pre and post-tnf blocker

Conditions: Arthritis, Rheumatoid; Spondylitis, Ankylosing

Summary: the purpose of this study is to determine possible alterations in cardiac function in patients with rheumatoid arthritis and ankylosing spondylitis under anti-tnf therapy, without clinical heart disfunction at baseline, using highly sensitive non-invasive methods.


Eligibility criteria:
inclusion criteria: * diagnosis of rheumatoid arthritis eligible to receive tnf blockers * diagnosis of ankylosing spondylitis eligible to receive tnf blockers exclusion criteria: * clinical heart failure * chagas'disease * stable or unstable angina * past history of myocardial infarct * systemic árterial hypertension (grade 3) * valvulopathy * chronic kidney disease

Keywords: infliximab adalimumab etanercept heart failure diastolic disfunction tnf blocker anti-tnf echocardiography tissue doppler imaging brain natriuretic peptide nt-probnp
monitoring and predicting breast cancer neoadjuvant chemotherapy response using dosi

Conditions: Breast Tumor

Summary: the purpose of this research study is to help us learn if an experimental imaging device called diffuse optical spectroscopic imaging (dosi) can monitor tumor shrinkage during chemotherapy treatment and can predict if the tumor will respond to chemotherapy before the end of the treatment. this study will also help us understand the biological reason for how dosi works.

there is considerable interest in developing imaging protocols to monitor and predict breast cancer response to neoadjuvant chemotherapy (nac), which is chemotherapy given before surgical removal of the tumor, both prior to and as early as possible during the course of treatment. the efficacy and practicality of conventional imaging approaches in the nac setting varies and identifies the need for alternate functional imaging strategies. diffuse optical spectroscopic imaging (dosi) is an experimental imaging method that allows patients to be followed before and during treatment with a cost-effective, bedside, handheld scanning probe. dosi is a non-invasive technology developed at the university of california, irvine beckman laser institute. studies will be performed at seven clinical sites on approximately 200 suspected breast cancer patients, of which 150 are expected to undergo neoadjuvant chemotherapy (nac). as a primary aim, the investigators will evaluate whether dosi can predict nac pathologic complete response (pcr), which is defined as no tumor cell left in the resected tissue at surgery) by the mid-point of the therapy regimen. as non-invasive dosi is obtained rapidly with no risk/discomfort, this experimental imaging modality could be used as an indicator of pathologic response which has been an established indicator of long-term survival. the investigators long-term goal is to provide oncologists with a relatively simple, risk-free bedside tool that can be used to help inform medical decisions on chemotherapy regimen, duration, and timing of surgery, thereby maximizing therapeutic response and minimizing unnecessary toxicity.

Eligibility criteria:
inclusion criteria: * females between the ages of 21 and 80. specific to study part #1 * diagnosed with a breast imaging-reporting and data system score of 4 or higher breast abnormality greater than 1cm in size specific to study part #2 * enrolled in study part #1 * diagnosed with histologically-proven invasive breast cancer * prescribed neoadjuvant chemotherapy for breast cancer exclusion criteria: * pregnant * unable to give written, informed consent.

Keywords: neoadjuvant therapy diffuse optical spectroscopic imaging dosi neoadjuvant chemotherapy
ultrasound (us) guided external ventricular catheter placement

Conditions: Hydrocephalus

Summary: to assess the accuracy the solopass® system us based in the placement of external ventricular drain into the cranial cavity. this study will aim at evaluating the proposed efficacy of the device in targeting the brain ventricles and decrease multiple brain passes, incorrect deployment and malfunctioning of the drain.


Eligibility criteria:
inclusion criteria: * decision made to perform the procedure by the primary consultant * age 18 or older * neuro icu stay * newly diagnosed hydrocephalus * has a recent ct within the past 24 hrs * normal platelets and coagulation profile * no active infection or currently on antibiotics * the targeted fluid compartment has more than 50 percent csf vs blood by ct scan imaging exclusion criteria: * age \<18 * not in neuro icu setting * previous placement of a ventricular catheter * more than 50 percent of the fluid compartment is filled with blood by ct scan * time to include in the trial prohibited by clinical personnel
traditional chinese medicine for the treatment of perennial allergic rhinitis on gut microbiota and immune-modulation

Conditions: Allergic Rhinitis

Summary: 40 allergic rhinitis patients in the acute phase will be enrolled in the study. all the allergic patients should be confirmed those who are over 20 years old and hypersensitive to house dust mite allergens confirmed by mast test before study. all patients were treated with mixed formula of chinese medicine for one months.

perennial allergic rhinitis is an important disease in traditional chinese medicine (tcm) due to its high prevalence rate in taiwan. in our previous studies, a new mixed formula of chinese herbs was evaluated for the treatment of allergic rhinitis. in these studies, we found that immunoduoatory effects of chinese medicine include: cd4+ t lymphocytes; regulatory t cells; dendritic cells, and regulatory b cells. these results allow us to confirm the immunomodulatory effects of mixed formula of traditional chinese medicine. in recent years, more and more attention has been paid to the effects of gut microbiota on immune-modulation. many immunomodulaotry effects of allergic diseases were considered to be closely related to gut bacteria. however, the research on allergic rhinitis is still rare, especially related to tcm treatment. from our previous studies, it has been confirmed that tcm have an immunomodulatory effect on allergic rhinitis. whether or not they are associated with gut microbiota changes is still unknown. this year, we compared the difference of composition and diversity of gut microbiota of allergic rhinitis patients and normal individual. indeed, we found it were different between allergic patients and normal individuals. the results of this study will provide us the information to understand whether the immunemodulation of tcm treatment on allergic rhinitis is correlated with the changes of gut microbiota.

Eligibility criteria:
inclusion criteria: * volunteer for study enrollment and sign inform consent * mite allergy confirmed by mast test * over 20 years old * will have their blood collected twice and stool samples * allergic rhinitis patients in the acute phase will be treated with mixed formula of chinese medicine for one months exclusion criteria: * women who are pregnant or breast-feeding * under treatment of western medicine including steroid, antihistamine, leukotriene inhibitor, immunosuppressant or stop above medication less than one month * under acute inflammatory disease such as pneumonia, sinusitis, bronchitis and so on vasomotor type allergic rhinitis * history of allergy or adverse effect to chinese herbs, poor compliance of herbal medicine severe organ function impairment, such as heart failure, liver failure, renal failure (egfr \<60 ml/min/1.73 m2)

Keywords: perennial allergic rhinitis; gut microbiota; mixe formula of chinese medicine
efficacy and safety of clevudine compared with adefovir in patients with chronic hepatitis due to hepatitis b virus

Conditions: Chronic Hepatitis; Hepatitis B

Summary: the objectives of this study are to compare in nucleoside treatment-naïve subjects, the efficacy and safety of clevudine 30 mg once daily versus adefovir 10 mg once daily, each as monotherapy, for 48 weeks, 72 weeks, and 96 weeks.


Eligibility criteria:
inclusion criteria: * nucleoside treatment-naïve subjects of either gender, females who are non-pregnant and non-lactating, aged 16 years or older (or the legal age of consent as allowed by local regulations), with compensated hepatic function despite a diagnosis of chronic hbeag negative hepatitis b infection (i.e., based on serological, virological and histological markers) will be eligible for this study. * subjects entering the study with an historical biopsy will have chronic hepatic inflammatory injury at screening (knodell hai score ≥ 4 and modified ishak fibrosis score ≤ 5). * the number of subjects entering the study with an ishak fibrosis score of 5 will be limited to approximately 10%. if applicable, subjects must cease previous treatment with any form of alpha interferon 12 months prior to baseline. * for eligibility, subjects must meet the laboratory criteria for total bilirubin, prothrombin time, serum albumin, platelet count, absolute neutrophil count, ana titer and have a creatinine clearance of ≥ 50 ml/min. exclusion criteria: * subjects participating in a clinical trial or receiving an investigational agent for any reason within 60 days of baseline will be excluded. * subjects with clinically significant concomitant diseases will be excluded.

Keywords: nucleoside treatment-naïve patients with hbeag negative chronic hepatitis due to hepatitis b virus hepatitis b virus