Kornimate/medical-research-clean huggingface dataset:
study to investigate the safety and pharmacokinetics of ser120 nasal spray in elderly patients with nocturia

Conditions: Nocturia

Summary: the purpose of this study is to determine if ser120 nasal spray is well tolerated in 75 years or older nocturic patients.

patients entering the study are randomized to either level 1 ser120 nasal spray concentration or level 2 ser120 nasal spray concentration

Eligibility criteria:
inclusion criteria: * male \& female greater or equal to 75 years of age, history of nocturia exclusion criteria: * chf, diabetes, diabetes insipidus, renal insufficiency, heptatic insufficiency, incontinence, illness requiring steroid, current or past urologic maliganancy, nephrotic syndrome * unexplained pelvic masses * urinary bladder surgery or radiotherapy * sleep apnea
nagasaki and tokushima

Conditions: Periodontitis

Summary: we analyzed the relationship between oxidative stress, immunoglobulin g antibody titers, cytokines, and periodontitis through community-based study held in the goto city, japan.


Eligibility criteria:
inclusion criteria: more than 15 teeth exclusion criteria: less than 15 teeth

Keywords: oxidative stress, antioxidant, periodontitis, serum immunoglobulin g antibody titer
risk-adapted conditioning regimen for allogeneic hematopoietic stem cell transplantation

Conditions: Allogeneic Hematopoietic Stem Cell Transplantation; Allogeneic Stem Cell Transplantation; Hematologic Malignancies

Summary: this is a prospective, single-arm, phase ii study. patients will be treated with an allogeneic stem cell transplantation (ahsct) using fludarabine, melphalan and total body irradiation (tbi) conditioning with different melphalan and tbi doses based on patient- and disease-related risk.

eligible patients will receive an allogeneic stem cell transplantation using a combination of fludarabine, melphalan and total body irradiation (tbi) conditioning regimen and post-transplant high dose cyclophosphamide (ptcy), tacrolimus and mycophenolate mofetil (mmf) for graft-versus-host prophylaxis. melphalan and tbi doses will be tailored based on the hematopoietic stem cell transplant- composite risk (hct-cr), age and karnofski performance status (kps). melphalan dose ranges from 100 -140 mg/m2 while tbi dose ranges from 2-5 gy. all patients will be monitored for safety and efficacy up to 2 years post-transplantation.

Eligibility criteria:
inclusion criteria: 1. male or female aged 18-70 years 2. diagnosis of aml, all, mds, cml, nhl, hd, cll requiring ahsct 3. has an hla-matched related (mrd), hla-matched unrelated (mud), haploidentical (haplo) or 1-ag mismatched unrelated donor (mmud) 4. karnofsky performance \>70% 5. adequate major organ system function as demonstrated by: 1. serum creatinine clearance equal or more than 50 ml/min (calculated with cockroft-gault formula). 2. bilirubin equal or less than 1.5 mg/dl except for gilbert's disease. alt or ast equal or less than 200 iu/ml for adults. conjugated (direct) bilirubin less than 2x upper limit of normal. 3. left ventricular ejection fraction equal or greater than 40%. 4. diffusing capacity for carbon monoxide (dlco) equal or greater than 50% predicted corrected for hemoglobin. 6. ability to understand and the willingness to sign a written informed consent. a. both men and women and members of all races and ethnic groups are eligible for this trial. non-english speaking, deaf, hard of hearing and illiterate individuals are eligible for this trial. exclusion criteria: 1. inability to comply with medical recommendations or follow-up 2. pregnancy 3. active/uncontrolled bacterial or viral infection (pi is the final arbiter of this criterion.) 4. has active cns or ocular disease involvement within 3 months 5. patients with primary cns lymphoma 6. patients who require modifications of the conditional regimen

Keywords: allogeneic hematopoietic stem cell transplantation allogeneic stem cell transplantation ahsct hematologic malignancies melphalan hematopoietic stem cell transplant -composite risk
laser therapy prevents mucositis oral in chemotherapy for bone marrow transplantation?

Conditions: Oral Mucositis; Effects of Chemotherapy; Malignant Neoplasm of Bone Marrow

Summary: setting: oral mucositis is a very common complication of cancer treatment, accounting, often at increased risk for infections and even the interruption of treatment, interfering with the prognosis of the disease. the low intensity laser therapy has been proposed as an alternative for the treatment and prevention of this side effect, with good results in terms of clinical and functional, speeding up the process of wound healing and reducing pain. objective: to evaluate the effectiveness of using low power laser in the prevention of oral mucositis in patients with hematological cancer, undergoing chemotherapy for bone marrow transplantation. methods: there will be a clinical trial randomized, double-blind study to evaluate the effectiveness of using low power laser in the prevention of oral mucositis in patients with hematological cancer, undergoing chemotherapy for bone marrow transplantation. participate in the study, patients who are in the condition mentioned above accepting participate and have aged over 18. will be excluded from the study patients who have autoimmune disease, which present sensitivity to laser or who have already started treatment for oral mucositis prior to this study.the study variables are:-independent variable: whether or not the red laser of low power-dependent variables: oral mucositis, degree of mucositis, chemotherapy regimen, type of blood cancer. for determining the association between the independent variable and the dependent will be used chi-square tests of association (pearson) and fisher's exact test, if necessary. will calculate the risk ratio (rr) as a measure of relative risk, with the confidence interval at 95% (ic95%).also be calculated nnt (number needed to treat to obtain benefit) and nnh (number needed to harm getting). will be adopted a significance level of 5%. the project was approved by the ethics and research imip. all patients will be appropriately informed about the objectives of the project and will only be included if they voluntarily agree to participate by signing the consent form. keywords: laser, prevention and control; oral mucositis, bone marrow transplant.

inclusion criteria: patients with blood cancers undergoing chemotherapy for bmt; patients who agree to participate; patients older than 18 years. exclusion criteria: patients with autoimmune diseases; patients who have sensitivity to the laser; patients who have already started treatment for mucositis prior to the research; hiv-positive patients.

Eligibility criteria:
inclusion criteria: * patients with hematologic cancers undergoing chemotherapy for bmt; * patients who agree to participate; * patients older than 18 years. exclusion criteria: * patients with autoimmune diseases; * patients who have sensitivity to the laser; * patients who have already started treatment for mucositis prior to research.

Keywords: oral mucositis chemotherapy bone marrow transplantation
a phase 2 clinical trial to evaluate the efficacy and safety of vsa006 in chinese nash patients

Conditions: Nash

Summary: human genetic studies have shown that loss of function (lof) mutations in hsd17β13 gene have a protective effect on the progression of alcohol-related and non-alcohol-related liver diseases, such as nash, without significant adverse phenotypes. vsa006 is a sirna drug targeting hsd17β13 mrna in the liver and reduce the protein level of hsd17β13. based on phase 1 study results in healthy volunteers and nash/suspected nash patients, this phase 2 study is designed to evaluate the efficacy, safety, pk profiles and immunogenicity of vsa006 in chinese nash patients.


Eligibility criteria:
inclusion criteria: * body mass index (bmi) of 24-35 kg/m2 ; * nash patients confirmed by liver histopathology: nas score is ≥ 4 and crn fibrosis is f2 or f3 ; * at screening, alt is \> uln; * at screening, the liver fat content measured by mri-pdff is ≥ 8%; * weight change \< 5% at least 3 months prior to screening; * for patient with t2dm, the hypoglycemic agents and hba1c is stable exclusion criteria: * pregnant or lactating women; * previous diagnosis of alcoholic liver disease or hepatitis/liver disease due to other causes; * previous or current diagnosis of cirrhosis or decompensated cirrhosis; * previous or current diagnosis of hyperthyroidism, hypothyroidism, or other diseases that can lead to fatty degeneration of liver; * participants diagnosed with type 1 diabetes, or with unstable type 2 diabetes * participants who cannot receive an mri examination;

Keywords: efficacy safety hsd17β13
a wearable nerve stimulator for chronic migraine/headache and mood disturbance in adolescents

Conditions: Migraine in Adolescence; Headache; Mood Disturbance

Summary: the aim of this clinical trial is to test a wrist-worn nerve stimulator in adolescents with chronic migraine/headache and mood disturbance. the main question it aims to answer is whether this device is effective in relieving clinical symptoms including pain, anxiety, depression and sleep disturbance. participants will wear the device for twelve weeks and complete monthly surveys throughout the study.

the aim of this study is to evaluate the effectiveness of the apollo neuro device on remediating clinical and physical symptoms of adolescents struggling with chronic migraine/headache with overlapping mood disturbance. this device is worn on the wrist and produces silent, low-frequency waves that feel like slight vibrations. an apollo neuro device will be offered as part of a treatment plan to patients with chronic neurological symptoms. patients will be placed in either a treatment or waitlist treatment group randomly. those in the treatment group will immediately use the apollo neuro device for twelve weeks and those in the waitlist group will follow the standard plan of care for twelve weeks. at twelve weeks the initial treatment group will conclude their time in the study and the waitlist group will begin use of the device for another twelve weeks. patients will complete surveys when they are given the apollo neuro device, monthly while using the device, and after twelve weeks of use. the waitlist group will also complete surveys upon enrolling in the study and monthly thereafter until the completion of their intervention. the findings of this study will further the understanding of autonomic dysfunction symptomology and recovery in the diagnosis of adolescent chronic headache/migraine and evaluate the effect of nerve stimulation as a means of mediating autonomic nervous system dysfunction and reducing symptoms in these patients.

Eligibility criteria:
inclusion criteria: * a diagnosis of chronic headache/migraine * the ability to follow simple instruction exclusion criteria: * previous diagnosis of moderate or severe traumatic brain injury * history of mild traumatic brain injury/concussion within the last six months * history of schizophrenia or bipolar disorder * history of epilepsy, cerebral palsy, or severe sensory disorders * history of stroke or neurodegenerative conditions
clinical trial of mycophenolate versus cyclophosphamide in anca vasculitis

Conditions: Vasculitis

Summary: the purpose of this study is to investigate whether mycophenolate mofetil is effective as treatment for new cases of anca associated vasculitis.

there is a clear need for improved therapy in anca associated vasculitis where current treatments are toxic and contribute to poor outcomes. conventional therapy combines cyclophosphamide with prednisolone but is associated with severe adverse events in 35%, early mortality, malignancy and infertility. mycophenolate mofetil (mmf) is a newer immunosuppressive drug which has superior efficacy to azathioprine in solid organ transplantation. mmf is an effective alternative to cyclophosphamide in lupus nephritis. open label studies and retrospective surveys point to the efficacy and low toxicity of mmf in vasculitis. we hypothesise that mmf not be less effective than cyclophosphamide for remission induction in aasv. 140 new patients will be randomised to mmf 3g/day or a european consensus intravenous cyclophosphamide regimen, with the same prednisolone dosing. following a six month induction course all patients will receive consensus remission maintenance treatment with azathioprine and prednisolone. the primary end-point will be remission rate by six months, secondary end-points include relapse rate at 18 months and safety. the trial will be conducted in 10 countries by members of the european vasculitis study group (euvas). the trial duration will be 42 months (24 months recruitment, 18 months follow up).

Eligibility criteria:
inclusion criteria: inclusion (requires all): * new diagnosis of aasv (wg or mpa) (within the previous six months) * active disease (defined by at least one major or three minor bvas 2003 items, see appendix 1) * anca positivity (c-anca and pr3-anca or p-anca and mpo-anca) or histology confirming active vasculitis from any organ (see appendix ) * written informed consent exclusion criteria: * previous treatment with: * mmf: more than two weeks ever. * cyclophosphamide: more than two weeks daily oral or more than 1 pulse of iv cyc (15mg/kg) * rituximab or high dose intravenous immunoglobulin within the last twelve months * active infection (including hepatitis b, c, hiv and tuberculosis). * known hypersensitivity to mmf, aza or cyc. * cancer or an individual history of cancer (other than resected basal cell skin carcinoma). * females who are pregnant, breast feeding, or at risk of pregnancy and not using a medically acceptable form of contraception. * any condition judged by the investigator that would cause the study to be detrimental to the patient. * any other multi-system autoimmune disease including churg strauss angiitis, sle, anti gbm disease and cryoglobulinaemia.

Keywords: vasculitis anca mycophenolate mofetil cyclophosphamide anti neutrophil cytoplasm antibody associated vasculitis
biomarker establishment for superior treatment of ptsd

Conditions: PTSD

Summary: the purpose of biomarker establishment for superior treatment of ptsd is to accelerate research on the discovery of biological, neurological and neuroimaging markers for post- traumatic stress disorder (ptsd). the investigators hope to validate and extend the network efficiency and verbal memory biomarker for ptsd. the investigators hope to learn whether there are pretreatment biological factors that can predict response to therapy. they want to do this by understanding the brain network function, relating eeg to functional magnetic resonance imaging, and application of network analysis tool.


Eligibility criteria:
inclusion criteria: * diagnosis of ptsd by va clinicians and acceptance into pe or cpt treatment as part of the pct * veterans of any era exclusion criteria: * mri safety contraindications * active, uncontrolled medical illness * acute suicidality * current substance dependence * current use of thyroid medication or active hyper/hypothyroidism * neurological disorder affecting the cns seg stroke, epilepsy, tumorw or penetrating head injury * use of prn within 48 hours of the mri/eeg

Keywords: veterans post traumatic stress disorder depression
evaluation of natureheme-iron on iron absorption effect and anti-oxidation functions

Conditions: Anemia

Summary: iron deficiency problem has always been in taiwan. this is a randomized, double-blind trial. subjects separate to 3 groups, one group (n = 20) take two natureheme-iron capsules a day for a total of 12 weeks, another group (n = 20) with the same dose of placebo, and the other group (n = 20) is a commercial iron supplement. investigators assess whether natureheme-iron can promote iron absorption and antioxidant effects, and compare the effects with commercial iron supplement. when this study is completed, it will increase the value of natureheme-iron, and can improve health of taiwanese.

fao / who noted that iron deficiency is still an important nutritional problem. iron deficiency problem has always been in taiwan. this study intends to use the products, natureheme-iron, using blood of pig to concentration, separation and extracted, and then got natural and clean natureheme-iron. natureheme-iron is not just a good iron supplement, while also providing an excellent source of natural protein. this is a randomized, double-blind trial, subjects separate to 3 groups, one group (n = 20) take two natureheme-iron capsules a day for a total of 12 weeks (1000mg fe / capsule), another group (n = 20) with the same dose of placebo, and the other group (n = 20) is a commercial iron supplement (100mg fe). investigators assess whether natureheme-iron can promote iron absorption and antioxidant effects, and compare the effects with commercial iron supplement. when this study is completed, it will increase the value of natureheme-iron, and can improve health of taiwanese.

Eligibility criteria:
inclusion criteria: * eligible subjects were anemia men or women aged over 20 years old with hb\<=12 g/dl. exclusion criteria: * subjects were excluded if subjects had a history of major cardiovascular disease, severe liver dysfunction, insulin-dependent diabetes mellitus or stroke. subjects were also excluded if they routinely consumed alcohol, were pregnant or unable to comprehend study instructions.

Keywords: hemoglobin serum iron serum ferritin hematocrit antioxidant
study to assess the efficacy of ipratropium bromide associated with high dose salbutamol by repeated nebulisation versus repeat nebulisation of salbutamol alone, in acute asthmatic attacks in young children

Conditions: Asthma

Summary: to determine whether addition of ipratropium bromide to salbutamol nebulisations produces significantly greater bronchodilation in young children presenting to an emergency department with an acute attack of asthma


Eligibility criteria:
inclusion criteria: * boys or girls between 3 and 6 years old * presenting to emergency departments with an acute asthmatic attack * requiring nebulised bronchodilator therapy * rint increased by 200 % compared to theoretical rint * signed, informed consent obtained from the child's parents/legal guardian in accordance with current national legislation and good clinical practice (gcp) defined by the international conference on harmonization (ich) exclusion criteria: * ipratropium bromide received within four hours before admission * first acute asthmatic attack * hospital admission to intensive care with asthma within six months before inclusion * hospital admission for asthma during the month prior to inclusion * corticosteroid-dependent asthma (oral corticosteroid therapy) or recently stopped corticosteroid therapy * concomitant cardiac disease * life threatening disease requiring immediate management; including: silent chest on auscultation, cyanosis, bradycardia less than 60 beats/min (bpm), confusion, coma * hypersensitivity to ipratropium bromide, salbutamol, or to any of their excipients * renal or hepatic insufficiency * poorly controlled diabetes * patients suffering from a disease considered to be severe by the investigator and which, in the opinion of the investigator, could interfere or invalidate the measurements performed in the trial * past history of lung surgery * major respiratory disease: pulmonary fibrosis, bronchiectasis, sarcoidosis, tuberculosis, respiratory disease due to aids, cystic fibrosis * patients unable to follow with protocol or correctly undergo the evaluations * patients who are taking part in another clinical trial during this trial or who have done so within the month before the trial * previous participation in this trial
electronic feedback on diabetic care to general practitioners

Conditions: Type 2 Diabetes

Summary: the aim of this study is to determine whether electronic feedback to general practitioners on quality of type 2-diabetes care increases the quality of care measured on process and outcome measures contained in the national guidelines. effect evaluation will be performed using a mixed method design.

background: in an effort to optimize diabetes care in general practice, an electronical feedback system has been developed. the system will be evaluated both quantitative and qualitative. method: the general practitioners (gp´s) of the region of southern denmark have been randomised to either admission or no admission to the electronic feedback system. the system was launched 1/3-2007 and ran for one year prior to evaluation. quantitative evaluation by assessment of the following end-points: patients hba1c-level, number of patients who have had their hba1c-level measured within the last year, cholesterol-level and number of patients who have had an eye examination within the last year. qualitative evaluation by interviewing gp´s who have had admission to the system. qualitative data have been collected through interviews with intervention gps, designed to uncover motivational factors as well as barriers concerning the use of feedback on chronic care in general practice. data are being analyzed. quantitative data are being gathered. perspective: this project will shed light on the value of electronic feedback systems within chronic care in general practice. based on this project it will be possible to set up a system for automatic electronic monitoring and feedback of the quality of care in general practice, taking motivational factors of the gp s into account during implementation.

Eligibility criteria:
inclusion criteria: * prevalent type 2-diabetes as confirmed by primary care physician. * patient alive throughout the intervention period. * gp actively working throughout the intervention period (not retired). exclusion criteria: * death during intervention * moved out of geographic area during intervention * gp retired during intervention

Keywords: quality of care general practice electronic feedback system
pressurized intraperitoneal aerosol chemotherapy (pipac) applied to platinum-resistant recurrence of ovarian tumor

Conditions: Ovarian Epithelial Cancer Recurrent; Platinum-resistant

Summary: patients with first recurrent resistance ovarian cancer and disease progression with peritoneal carcinomatosis will undergo pipac procedure. the primary end point is to determine the clinical benefit rate (cbr) of a pressurized intraperitoneal aerosol chemotherapy with a combination of cisplatin and doxorubicin.

this study aims to investigate the therapeutic efficacy of pipac using cisplatin and doxorubicin in women with first recurrent resistance ovarian cancer and disease progression with peritoneal carcinomatosis. the primary objective of this study is to determine the clinical benefit rate (cbr) according to recist/gcog criteria after three cycles of pipac with pipac cisplatin and doxorubicin

Eligibility criteria:
inclusion criteria: * patients affected by first or second platinum resistant epithelial ovarian tumor recurrence. * ecog-performance status ≤ 3. * adequate respiratory, hepatic, cardiac, kidney and bone marrow function (absolute neutrophil count \> 1500 / mm3, platelets \> 150 000/μl, creatinine clearance \> 60 ml / min according to cockroft formula). * patient-compliant and psychologically able to follow the trial procedures. exclusion criteria: * non-epithelial ovarian cancer or borderline ovarian tumor. * pregnancy or breastfeeding. * patients affected by major depressive disorder even in treatment or minor mood disorders. * patients with severe impairment of respiratory, hepatic or renal function. * patients with cardiac, neurological or metabolic uncontrolled pharmacologically disease * patients with bowel obstruction. * inadequate bone marrow, liver, kidney function. * no clear-peritoneal disease at surgical exploration. * patients with ascites \>2000 cc (ct-scan) * patients who have already made third line chemotherapy.