Kornimate/medical-research-clean huggingface dataset:
esomeprazole treatment for patients with lymphocytic gastritis

Conditions: Lymphocytic Gastritis

Summary: the purpose of this study is to determine whether treatment with esomeprazole alone is able to heal patients with lymphocytic gastritis

recently, a placebo controlled trial of our group has shown that h. pylori eradication therapy consisting of omeprazole 20 mg bid, clarithromycin 500 mg bid, amoxicillin 1000 mg bid for seven days leads to a complete long-lasting resolution of lymphocytic gastritis in 96 % of patients. however, after 3 months we also found a healing rate of 50 % in patients who received omeprazole 20 mg bid and placebo antibiotics for seven days suggesting spontaneous remission or a potential ppi effect. thus, we speculate that ppi therapy may have led to elimination of h. pylori and subsequently healing of lymphocytic gastritis in those patients with potentially minimal h. pylori colonization at baseline. for this reason we investigate whether a ppi treatment alone is able to heal patients with lymphocytic gastritis.

Eligibility criteria:
inclusion criteria: * histologically proven lymphocytic gastritis (iel \> 25/100) * male or female aged 18 years or older * signed and written informed consent exclusion criteria: * regular nsaid or aspirin intake * concomitant medication with antibiotics, bismuth subsalicylate, aminosalicylates * regular ppi therapy * treatment with ketoconazole or other cyp3a inhibitors * previous surgery of the stomach * known or suspected hypersensitivity to esomeprazole * malignant diseases * concomitant severe diseases * pregnancy or lactation * contraindication to take biopsies (quick \ 50 s, thrombocytes \< 100.000/mm3)
sleep and osa on reproductive function in men

Conditions: Obstructive Sleep Apnea

Summary: in view of the hormonal changes induced by both sleep deprivation and obstructive sleep apnea syndrome (osa), and the importance of maintaining these hormones in reproductive processes. the present study aims to evaluate the effects of the osa or sleep deprivation (total or selective rem sleep for 48h) on reproductive function in adult men with normal body mass index.

in this study will be recruited volunteers 25-50 years of age with a body mass index (bmi) 20-25 kg/m2 (normal) that after performing polysomnography, will be distributed in the following groups: healthy or diagnosed with obstructive sleep apnea syndrome (osa). volunteers without osa will be submitted to total sleep deprivation (sd) or selective rem sleep deprivation for 48 hours. after sd, these volunteers will be allowed to sleep for 48 hours (period rebound). blood samples will be taken for hormonal analysis (testosterone, luteinizing hormone, follicle-stimulating hormone, progesterone and cortisol)and gene expression. the semen collection for evaluation of sperm count (concentration, viability and sperm morphology) in three different periods, baseline collection, after sd protocols and the end of rebound period. individuals diagnosed with osa also have three collections of blood and semen samples for analyzes.

Eligibility criteria:
inclusion criteria: * men * there is no discrimination of economic class * age between 25 and 50 * bmi 30 kg/m2 * no prior neurological, psychiatric or use of psychotropic medication * osa (moderate and severe apnea hypopnea index \> 15) exclusion criteria: * smokers * addiction * individuals with another sleep disorder * severe uncontrolled organic disease that might interfere with the conduct of the study, such as cancer, heart disease, digestive disorders, diabetes mellitus, male reproductive system * presence of moderate or severe depression and psychiatric disorders * volunteers with previous treatment for osa

Keywords: sleep obstructive sleep apnea reproduction sperm hormones men
using the canary breathing system for panic disorder patients

Conditions: Panic Disorder

Summary: the purpose of this study is to test the effectiveness of the canary breathing system (cbs) in treating the symptoms of panic disorder.

panic disorder (pd) is associated with hyperventilation. the efficacy of a brief respiratory feedback program for pd has been previously established. the aim of the present study was to expand these results by testing a similar program with more clinically representative patients and settings. the intervention is delivered via home use following initial training by a clinician and provides remote monitoring of client adherence and progress by the clinician. outcomes were assessed post-treatment and at 2- and 12-month follow-up.

Eligibility criteria:
inclusion criteria: * primary diagnosis of panic disorder * subjects between 18 and 60 years of age (inclusive on day of enrollment) * subjects with a clinician's global impression of \> or = to 4. * if on psychotropic medication, on a stable dose for a minimum of 3 months prior to enrollment * if on psychotropic medication, an agreement to stay on their stable dose from study entry until the 2-month follow-up. exclusion criteria: * pregnancy * current enrollment in another drug or device study * current enrollment in another drug or device study that is not at least 30 days past the final follow-up * currently undergoing cognitive behavioral therapy (or equivalent) * refractory to either a breathing training program or cognitive behavioral therapy (or equivalent) in the 3 months prior to enrollment * evidence of organic mental disorder * severe suicidality * presence of any psychotic disorder * bipolar disorder that is present for \< 5 years; a major depressive, manic or hypomanic episode in the last 12 months; failure to take and maintain a stable dose of medication in treatment of bipolar disorder in the last 12 months * current alcohol or drug dependence * cardiovascular or pulmonary disease * epilepsy or seizures * undergoing additional psychologic treatment at any point from study enrollment to 2-month follow-up to treat panic disorder

Keywords: carbon dioxide monitoring panic disorder biofeedback breathing training primary diagnosis panic attacks
rivaroxaban in patients with atrial fibrillation and coronary artery disease undergoing percutaneous coronary intervention

Conditions: Atrial Fibrillation

Summary: to evaluate the safety for the combination of rivaroxaban and ticagrel versus triple antithrombotic regimen (vitamin k antagonist (vka), clopigogrel and aspirin) in patients with atrial fibrillation and coronary artery disease undergoing percutaneous coronary intervention (pci).

this is an open-label (both physician and participant know the treatment that the participant receives), randomized (study medication is assigned by chance), multicenter clinical study assessing the safety of the combination of rivaroxaban and ticagrel versus triple antithrombotic regimen (warfarin, clopigogrel and aspirin) in patients, who have paroxysmal, persistent, or permanent non-valvular atrial fibrillation (af) and concomitant coronary artery disease undergoing percutaneous coronary intervention (pci). a target of 420 participants will be randomized into the study, with approximately 210 participants in each treatment strategy group. primary comparisons will be made of the rates of major and clinically relevant bleeding, assessed by the modified international society of thrombosis and haemostasis (isth) classification. the study consists of a screening phase, a 12-month open-label treatment phase, and an end-of-treatment/early withdrawal visit. the total duration of participation in the study for each participant is approximately 12 months.

Eligibility criteria:
inclusion criteria: * a long-term indication for oral anticoagulation treatment (until at least 1 year after the study) * a severe coronary lesion (at least 75% stenosis on angiography or fractional flow reserve lower than 0•80) with indication for pci * age 18-80 years exclusion criteria: * history of intracranial bleeding; * cardiogenic shock; * contra indication to use of antiplatelet or anticoagulation drugs; * peptic ulcer in the previous 6 months; * thrombo cytopenia (platelet concentration lower than 50\~10⁹/l); * major bleeding (according to the thrombolysis in myocardial infarction \[timi\] criteria) in the past 12 months; and * pregnancy.

Keywords: safety rivaroxaban ticagrel triple antithrombotic regimen undergoing pci
serum vasopressin levels and severe hemorrhagic shock

Conditions: Injury

Summary: the purpose of this study is to determine if vasopressin is used up by the body during traumatic shock (severe low blood pressure due to trauma).

for humans suffering trauma and severe hemorrhagic shock, no randomized controlled studies of the effect of exogenous vasopressin use exist, although case reports have suggested it may be of benefit. even some moribund patients with "irreversible" shock survived severe hemorrhagic shock after administration of vasopressin. this suggests that at least some patients suffering severe trauma could benefit from aavp administration. recently, many clinicians and notable research consortiums have suggested that avp shows promise for human resuscitation and have called for further human studies. this is a prospective, single-center observational study designed to evaluate (1) whether vasopressin is depleted in severe, but not minor, trauma; and (2) the degree to which endogenous vasopressin levels predict the occurrence of ards, sepsis, or death. to test the first hypothesis, serum vasopressin levels (continuous independent variable) will be assessed at enrollment (time 0), 6, 12, 18, and 24 hours later, and correlated with the two levels of trauma (categorical dependent variable). to test the second hypothesis, serum vasopressin levels (now a continuous dependent variable) will be correlated with each of three outcomes-death, ards, and sepsis.

Eligibility criteria:
inclusion criteria: patients with a minor injury or injuries, defined as: 1. no episodes of systolic blood pressure \< 90 mmhg between occurrence of injury and admission; 2. no blood transfusion requirement; 3. base deficit \< 5 meq/l; 4. no requirement for mechanical ventilation other than transiently during orthopedic surgery. exclusion criteria: 1. pregnancy 2. corticosteroid use, 3. prisoners, and/or 4. head trauma as determined by computed tomography (head trauma may itself induce diabetes insipidus, a marker of pituitary damage and vasopressin deficiency), and/or 5. evidence of spinal cord injury (another cause of vasodilatory shock). patients will also be excluded if pre-hospital provider information cannot be obtained, or indicates that the trauma occurred more than one 1 hour prior to emergency department admission.

Keywords: vasopressin trauma injury
mhealth usage among nigeria women diagnosed with breast cancer receiving chemotherapy

Conditions: Breast Cancer

Summary: the research is studying the effect of a mhealth psychoeducational intervention on self-efficacy, coping and psychological distress of nigerian women diagnosed with breast cancer receiving chemotherapy the study is a two-arm assessor-blinded randomised controlled trial which will be conducted in two university teaching hospitals in nigeria.

aim the study aims to develop and implement a culturally adapted mhealth psychoeducational intervention (mpei) for nigerian women diagnosed with breast cancer receiving chemotherapy. objectives 1. to evaluate the effectiveness of the programme on self-efficacy (primary outcome), coping, symptom distress, anxiety, depression, and quality of life (secondary outcomes) among women with breast cancer receiving chemotherapy 2. to explore the participants' experiences and feelings towards the intervention. hypothesis it is hypothesised that participants who receive the mpei program, when compared with the control group at baseline and immediately after the intervention, will demonstrate: 1. a significantly higher level of self-efficacy, 2. a significantly higher level of coping, 3. a significantly higher level of quality of life, 4. a significantly lower level of symptom distress, 5. a significantly lower level of anxiety and depression.

Eligibility criteria:
inclusion criteria: include females who are: 1. newly diagnosed with breast cancer within the recent three months 2. currently receiving chemotherapy, 3. have access to a smartphone and internet, 4. are able to read and write in english, 5. are cognitively capable of completing the questionnaires, 6. consent to join the study. exclusion criteria: include females: 1. with a concurrent physical or mental illness (as these might act as a confounder) 2. cognitively impaired

Keywords: chemotherapy women psychoeducation mhealth nursing psychological issues nigeria
interest of propionibacterium freudenreichii for the treatment of mild to moderate ulcerative colitis

Conditions: Ulcerative Colitis

Summary: ulcerative colitis (uc) is an immune mediated chronic inflammatory bowel disease that results at least in part of an abnormal immune response to environmental factors including the intestinal microbiota. thus, use of probiotics (microorganisms that are believed to provide health benefits when consume) may restore the gastrointestinal microbiota and reduce intestinal inflammation. propionibacterium freudenreichii is used for the production of fermented food products (cheese). some selected strains have strong anti-inflammatory properties. use of cheese based on a monoxenic culture of anti-inflammatory strain of propionibacterium freudenreichii may decrease disease activity during ulcerative colitis.


Eligibility criteria:
inclusion criteria: * patient with age above 18 years old * patient with diagnosis of ulcerative colitis for at least 6 months. * patient with mayo endoscopic score ≥ 1 * patient with mild to moderate disease activity (3 \< scci \< 12) * ongoing treatment by mesalamine, steroids, thiopurines or tumor necrosis factor antagonist at stable dose. * patients who have given written informed consent. exclusion criteria: * adults legally protected (under judicial protection, guardianship, or supervision), persons deprived of their liberty. * psychiatric disease that alter the judgment * stoma * proctocolectomy * severe disease (scci \>12, acute severe colitis) * steroid dose \> 10 mg/j or introduction of steroid (topic or oral) within 4 weeks * introduction or dose optimization of tnf antagonist within 4 months * introduction or dose optimization of thiopurine * hemoglobin level \ 400000/mm3, leukocytosis \> 10 000/mm3 * intolerant to lactose * disease extent limited to the rectum * mayo endoscopic subscore of 3

Keywords: ulcerative colitis probiotics treatments propionibacterium freudenreichii
association between insulin resistance and beta cell function with hba1c in diabetics

Conditions: Diabetes Mellitus, Type 2

Summary: progression of t2dm is widely accepted to be contributed by two main components: beta cell function deterioration where insulin secretion is impaired and insulin resistance where insulin physiological response is reduced. insulin resistance and beta cell function will be estimated through a mathematical model, homeostasis model assessment. fasting insulin and c-peptide will be measured using liquid chromatography tandem mass spectrometry. insulin resistance and beta cell function is then compared with the glycaemic control, hba1c.

primary objective • to investigate the association between the estimation of insulin resistance and beta cell function through homeostasis model assessment with hba1c among oral anti-diabetics treatment non-responder. secondary objectives * to compare the insulin resistance and beta cell function between the oad treatment responders (negative control) and non-responders * to investigate the relationship between plasma level of metformin and gliclazide with the estimation of beta cell function and insulin resistance * to identify the proportion of patients with high insulin resistance and proportion of patients with low beta cell function * to identify difference in insulin resistance and beta cell function of different ethnic groups in sarawak * to compare insulin resistance with cardiovascular disease risk using framingham risk score and ascvd risk estimation

Eligibility criteria:
inclusion criteria: * previously diagnosed to have t2dm, currently treated with oral anti-diabetics agents (either on maximum dose of metformin only or with maximum dose of gliclazide) for at least 3 months with no change in medications and dosage during the period of 3 months exclusion criteria: * patient that is on exogenous insulin, is on hormone replacement therapy or any steroids medications, with renal impairment with creatinine clearance less than 30ml/min and unable to provide informed consent

Keywords: homeostasis model assessment insulin resistance beta cell function liquid chromatography tandem mass spectrometry
safety and efficacy study of allogeneic human dental pulp mesenchymal stem cells to treat severe covid-19 patients

Conditions: COVID-19

Summary: this clinical trial is set out to evaluate the safety and efficacy of allogeneic human dental pulp mesenchymal stem cells in the treatment of severe pneumonia caused by covid-19; to explore the effects of human dental pulp mesenchymal stem cells in the treatment of severe pneumonia of covid-19 in terms of reducing mortality and improving clinical prognosis; and to discover a new therapeutic strategy for covid-19 using allogeneic human dental pulp mesenchymal stem cells.

this clinical trial is set out to evaluate the followings: 1. the safety and efficacy of allogeneic human dental pulp mesenchymal stem cells in the treatment of severe pneumonia caused by covid-19; 2. to explore the effects of human dental pulp mesenchymal stem cells in the treatment of severe pneumonia of covid-19 in terms of reducing mortality and improving clinical prognosis; and 3. to discover a new therapeutic strategy for covid-19 using allogeneic human dental pulp mesenchymal stem cells.

Eligibility criteria:
inclusion criteria: 1. aged 18-65 years; 2. voluntarily participate in this clinical trial and sign off "informed consent form"; 3. diagnosed with severe pneumonia of covid: respiratory distress, rr \>30 times / min; resting oxygen saturation of 93% or less; arterial partial pressure of oxygen / oxygen concentration 300mmhg; sars-cov-2 nucleic acid test was positive. 4. chest imaging confirm covid-19 featured lesions in lung. exclusion criteria: 1. receive any clinical trial drug treatment for covid-2019 within 30 days before the screening assessment; 2. severe liver disease (e.g., child pugh score \>=c or ast\> 5 times of the upper limit); 3. patients with known severe renal insufficiency (estimated glomerular filtration rate \<=30ml / min/1.73 m2) or patients receiving continuous renal replacement therapy, hemodialysis, peritoneal dialysis; 4. co-infection of hiv, hepatitis b, tuberculosis, influenza virus, adenovirus or other respiratory infection viruses; 5. female patients who have no sexual protection in the last 30 days prior to the screening assessment; 6. pregnant or lactating women or women using estrogen contraception; 7. patients who are planning to become pregnant during the study period or within 6 months after the end of the study period; 8. other conditions that the researchers consider not suitable for participating in this clinical trial.

Keywords: cronovirus human dental pulp stem cells dental stem cell banking
treatment de-intensification and residual hiv-1 in youth

Conditions: HIV-1; HIV Infections

Summary: this laboratory-based sub-study of atn 061 and atn 071 will examine the effect of early treatment followed by treatment de-intensification to atazanavir/ritonavir (atv/r) monotherapy on steady-state frequencies of replication-competent cd4+ t cell human immunodeficiency virus (hiv)-1 reservoirs or cell-associated infectivity (cai) and persistent low-level viremia (llv), and their contribution to successful long-term control of hiv-1 replication among hiv-1 infected adolescents and young adults.


Eligibility criteria:
081 participants must first be enrolled in either atn 061 or atn 071 and meet the eligibility criteria of those protocols in addition to those below. inclusion criteria: 061 participants * currently on treatment with an atv/r-based haart regimen (atv/r, ftc, tdf is the preferred regimen); * hiv-1 viral load \< 100 copies at week 24; * cd4+ t cell count \> 350 cells/mm3 at week 24; and * able to provide informed consent for the sub-study and adhere to the protocol. 071 participants * initiated haart according to current dhhs guidelines (cd4+ t cells \< 350 cells/ mm3); * currently on treatment with a pi-containing haart regimen; subjects taking a protease inhibitor other than atv/r must receive approval by the team via the atn qns; * plasma hiv-1 viral load \< 100 copies at week 24 on haart; measurement to be collected from clinical care results contained in the medical record at the clinical site within +/- 30 days of week 24 on therapy; * cd4+ t cell count \> 350 cells/mm3 at week 24 on haart; measurement to be collected from clinical care results contained in the medical record at the clinical site within +/- 30 days of week 24 on therapy; and * able to provide informed consent for the sub-study and adhere to the protocol. general exclusion criteria: * currently enrolled in the standard care arm of atn 061; * pregnancy or breast feeding; * severe (grade ≥ 3) anemia or other conditions that would not allow adequate blood volume to be drawn; * active treatment for systemic infections; * treatment with immune modulators, including immunosuppressive or immune modulating therapy (il-2, intravenous gammaglobulin, and therapeutic or other experimental vaccines including hiv-1 vaccine given for primary prevention at any time (short courses (\<14 days) of prednisone for reactive airway disease (rad) are permitted); * active hepatitis b infection as defined by hepatitis b antigen (ag) positive; * disallowed medications (see section 5.3.2); * active drug or alcohol use or dependence that, in the opinion of the site personnel, would interfere with adherence to the study; or * history of chronic renal insufficiency or grade 3 or greater serum creatinine. 061-specific exclusion criteria * history of an acquired immunodeficiency syndrome (aids)-defining illness; * meets any atn 061 exclusion criteria for de-intensification; or * meets any atn 061 premature study discontinuation criteria. 071-specific exclusion criteria: none

Keywords: de-intensification haart monotherapy persistent low-level viremia (llv) treatment experienced