Kornimate/medical-research-clean huggingface dataset:
assessment of a novel fixed-dose combination (fdc) drug vr-ad-1005 for the treatment of acute watery diarrhea in cholera

Conditions: Cholera

Summary: cholera still remains a global public health concern affecting both children and adults, and patients can succumb in quick time if remain untreated. cholera is a secretory diarrhea and is generally treated with oral or intravenous rehydration therapy to compensate for the fluid loss. however, antimicrobial treatment is given to patients with moderate to severe diarrhea. the consistent emergence of multidrug-resistant bacteria is a major concern for the management of infectious diseases including cholera. no antisecretory drug has so far been proven successful. in a phase ii clinical trial, the investigators will assess the effectiveness of a novel antisecretory drug vr-ad-1005 for treating cholera. changes in stool volume and rehydration therapy will be assessed for vr-ad-1005 in comparison with placebo. if successful, this will be a huge advance in managing cholera and other secretory diarrhea. the introduction of the antisecretory drug can minimize the hospital stay and reduce antibiotic use, which in turn can reduce the emergence of antibiotic resistance among pathogens


Eligibility criteria:
inclusion criteria: * signed informed consent. * adults, both genders aged 18-65 years. * acute watery diarrhea (defined as passage of three or more liquid stools within the 24 hours before admission) with severe dehydration on arrival. * detection of v. cholerae by rapid diagnostic assay (e.g. dark field microscopy). exclusion criteria: * known or suspected hypersensitivity to trial product(s) or related products. * subjects with passage of bloody stools or muco-purulent stools. * subjects with chronic diarrhea (\>4 weeks of diarrhea). * clinically significant concomitant systemic disease (i.e. cardiovascular diseases including heart failure, acute kidney injury, sepsis or life-threatening malignant cancer). * mental incapacity, unwillingness, or language barriers, precluding adequate understanding or cooperation. * history of receiving antimicrobial or antidiarrheal drugs within 6 hours prior to admission. * positive urine pregnancy test for all female patients * failure to obtain informed consent. * failure to definitively diagnose cholera via culture or rt-pcr
effectiveness of emdr in borderline personality disorder: a rct single-blind study in a real-world care setting

Conditions: Borderline Personality Disorder

Summary: borderline personality disorder (bpd) is a severe mental disorder characterized by four major symptomatological domains: interpersonal instability, perceptive and identity disorders, emotional and behavioural dysregulation. considering a multifactorial etiological model, it has been suggested that the interaction between behavioral, environmental and genetic factors may promote the development of bpd. early life stress events (els) in childhood and adolescence are highly prevalent in this population and constitute an environmental risk factor for the development of bpd. this correlates with the fact that post-traumatic stress disorder (ptsd) is frequently comorbid in bpd leading to more severe symptoms and worse psychosocial functioning. at the therapeutic level, the treatment of bpd is an open challenge as psychotherapeutic interventions are of limited effectiveness and characterized by high drop-out rates. eye movement desensitization and reprocessing (emdr) is the gold standard for treating ptsd. however, scientific evidence on the application of emdr in patients with bpd is limited. this study aims to assess the feasibility and effectiveness of an emdr protocol on the nuclear symptomatology of bpd (emotional and behavioral dysregulation) in a group of dbp patients with/without ptsd comorbidity, through a systematic assessment of the peculiar dimensions of the disorder. the basic hypothesis is that emdr, through a short-term intervention, can act both on the traumatic ptsd-like experiences reported by patients and on the clinical manifestations peculiar to dbp, in particular by improving the emotional regulation capacity of patients with bpd.


Eligibility criteria:
inclusion criteria: * patients must be over 18 years old * a current diagnosis of pbd according to the dsm-5 was confirmed using the scid-5-cv and scid-5-pd diagnostic scale exclusion criteria: * suicidal ideation in the last 3 months (suicidal thoughts active intentionally but without specific planning or suicidal thoughts active with planning and intentionality) * intellectual disability * any active disturbance from use of substances or alcohol * any other diagnosis of axis i, except for depressive disorders, anxious spectrum disorders, obsessive-compulsive disorder.
impact of n-acetylcysteine on oxidative stress and renal function in deceased kidney transplant recipients

Conditions: Deceased Kidney Transplantation

Summary: the aim of this interventional, prospective, randomized clinical trial is to evaluate the impact of the antioxidant n-acetylcysteine on oxidative stress in the first seven postoperative days and on renal function in the first three postoperative months in deceased kidney transplantation.


Eligibility criteria:
inclusion criteria: * first transplant * deceased kidney transplant exclusion criteria: * postoperative recovery at critical care unit * illicit drug addiction * psychiatric disorders

Keywords: kidney deceased kidney transplant oxidative stress renal function measurements
cp-690,550 and oral contraception drug-drug interaction study

Conditions: Healthy

Summary: this study is designed to assess whether co-administration of cp-690,550 and oral contraceptives will effect the metabolism of the oral contraceptives in healthy volunteers.


Eligibility criteria:
inclusion criteria: * healthy female subjects * no evidence of active or latent or inadequately treated infection with mycobacterium tuberculosis exclusion criteria: * any medical reason which would contraindicate the administration of oral contraceptives * clinically significant infections within the past 3 months or history of febrile illness within 5 days * positive screening test for hepatitis b surface antigen, anti hepatitis c antibody, or human immunodeficiency virus * pregnant or nursing women, and women of childbearing potential who are unwilling or unable to use an acceptable method of nonhormonal contraception

Keywords: drug interactions cyp3a oral contraceptive anti-rheumatic agents
impact of immediate point-of-care ultrasound on patients with cardiopulmonary symptoms in the emergency department

Conditions: Chest Pain; Dyspnea; Syncope; Hypotension

Summary: the purpose of the proposed research is to examine whether incorporating point-of-care ultrasound (pocus) early in diagnostic work-up of cardiopulmonary complaints will affect diagnosis, time to condition-specific intervention, and ultimately patient outcomes compared to usual care.


Eligibility criteria:
inclusion criteria: * chief complaint of chest pain, dyspnea (either sudden onset or increased severity of chronic dyspnea), syncope, or hypotension (systolic blood pressure \ 1) exclusion criteria: * \<18 years old * prisoner or ward of the state * trauma * high acuity requiring treatment in resuscitation room * obvious cause of symptoms (e.g. acute gi bleed causing hypotension) * any form of "do not resuscitate" (dnr) order * roomed in hall of emergency department (location not amenable to ultrasound protocol)

Keywords: ultrasonography
regional anesthesia and lung cancer recurrence

Conditions: Lung Cancer

Summary: test the effect of combined regiona/general anesthesia on lung cancer recurrence compared to general anesthesia alone.

surgery is the primary treatment of lung cancer, but surgery releases tumor cells into the systemic circulation. whether this minimal residual disease results in clinical metastases is a function of host defense. at least three perioperative factors shift the balance toward initiation and progression of minimal residual disease. (1) surgery per se depresses cell-mediated immunity, reduces concentrations of tumor-related anti-angiogenic factors (e.g., angiostatin and endostatin), and increases concentrations of pro-angiogenic factors such as vegf. (2) anesthesia impairs numerous immune functions, including neutrophil, macrophages, dendritic cells, t lymphocytes (t-cell), and natural killer cell (nk-cell) functions. (3) opioid analgesics inhibit both cellular and humoral immune function in humans, and promote tumor growth in rodents. regional analgesia attenuates each of these adverse effects. for example, regional anesthesia largely prevents the neuroendocrine stress response to surgery by blocking afferent neural transmission. with combined regional and general anesthesia/analgesia, the amount of general anesthetic required is much reduced - as is, presumably, immune suppression. and finally, regional analgesia provides superb pain relief, essentially obliterating the need for postoperative opioids. animal studies show that regional anesthesia improves natural kill cell function and reduces the metastatic burden in animals inoculated with carcinoma cells. preliminary retrospective data in cancer patients showed, that paravertebral analgesia for breast cancer surgery reduced risk of recurrence or metastasis by 40% during a 2.5 to 4-year follow-up period. the investigators thus propose to evaluate the effect of combined epidural-general anesthesia compared to general anesthesia on cancer recurrence semi-annually over a period of 5 years.

Eligibility criteria:
inclusion criteria: * primary non-small cell lung cancer (stage 1-3) as determined according to the iaslc lung cancer staging project; * scheduled for potentially curative tumor resection; * written informed consent, including willingness to be randomized to epidural anesthesia/analgesia plus general anesthesia or to general anesthesia and postoperative opioid analgesia. exclusion criteria: * any contraindication to epidural anesthesia, (including coagulopathy, abnormal anatomy). * any contraindication to midazolam, propofol, sevoflurane, fentanyl, morphine, or hydromorphone. * age \ 85 years old. * other cancer not believed by the attending surgeon to be in long-term remission.

Keywords: regional analgesia routine general anesthesia immune system response lung cancer (stage 1-3)
multiple dose study in treatment naive subjects infected with hepatitis c virus

Conditions: Chronic Hepatitis C

Summary: the purpose of this study is to determine the antiviral effect following three days of dosing with bms-824393 in chronically genotype subtype 1a and 1b hepatitis c virus (hcv) infected subjects.


Eligibility criteria:
inclusion criteria: * treatment naive chronically infected subjects with hepatitis c virus genotype 1 * hcv rna viral load of ≤10\*5\* iu/ml (100,000 iu/ml) * body mass index (bmi) of 18 to 35 kg/m², inclusive exclusion criteria: * women who are pregnant or breast feeding * any significant acute or chronic medical illness which is not stable or is not controlled with medication or is not consistent with hepatitis c infection * any other medical, psychiatric and/or social reason which, in the opinion of the investigator, would make the candidate inappropriate for participation in this study
assessing efficacy of axillary web syndrome treatment

Conditions: Axillary Web Syndrome

Summary: the aim of this study is verify the effectiveness of manual maneuver associated with stretching exercises in the treatment of axillary web syndrome.

axillary web syndrome (aws) is one of the short / medium-term sequela of surgical treatment for breast cancer with axillary dissection (ad) or sentinel lymph node biopsy (slnb), with incidence reported in literature between 28% and 72%. aws could be described as a thrombophlebitis of veno-lymph vessels due to a trauma of the region subjected to surgery, with the same characteristics of "mondor's disease" diagnosed in post-traumatic and surgical areas where is a large presence of veno-lymphatic capillaries. the syndrome onset occur in approximately 2-4 weeks after the surgery and its complete regression happen in 3-6 months after the onset. the clinical signs frequently described are pain and tension during movement in the axillary region, elbow, forearm and wrist, following the arm lymphatic pathway. moreover, patients report difficulties in moving the arm into activities that require a moderate range of motion and could feel and see in the affected arm cords similar to a tendon. even if the impairment can cause disability for a limited period of time, rehabilitation is usually advice to prevent further complications such as frozen shoulder, articular impeachment syndrome and long-term chronic pain, complications that could worsen patient's quality of life with a significant increase in costs and time to recovery. nowadays there are no studies in the literature that demonstrate the effectiveness of physiotherapy in aws, with just case reports describing different treatments techniques, without a scientifically defined experimented rehabilitation protocol. this experimental, monocentric, randomized clinical trial wants verify the effectiveness of a manual maneuver associated with stretching exercises in the treatment of aws.

Eligibility criteria:
inclusion criteria: * female patients with age between 18 and 70 years old * axillary dissection with or without plastic reconstruction with prothesis * positive diagnose of axillary web syndrome. * patients without mental or psychological problems which could affect the proposed treatment execution. * signed informed consensus form. exclusion criteria: * chronic or acute upper limb pathology which could affect the proposed treatment execution. * patients with mental or psychological problems which could affect the proposed treatment execution. * plastic reconstruction with abdominal (diep or tram) and dorsal grafts or with expander. * previous head and neck, sentinel lymph node biopsy or axillary dissection surgery. * previous breast, axillary or head and neck radiotherapy. * halsted mastectomy. * previous lymphedema. * bilateral axillary dissection surgery * physiotherapy treatment execute outside hospital during the study.

Keywords: breast neoplasm physiotherapy rehabilitation
post extubation chest physiotherapy in icu

Conditions: Weaning From Mechanical Ventilation

Summary: the purpose of this study is to examine the efficacy of chest physiotheray treatment in preventing pulmonary complications and weaning faliure, in extubated critically ill patients.


Eligibility criteria:
inclusion criteria:icu patients, over 18 years' old, mechanical ventilated over 24 hours, candidates for extubation - exclusion criteria: mental conditions, retardation, dementia, pregnancy, re-intubated patients -
amino acid nutrition in the critically-ill

Conditions: Critical Illness; Inflammation; Malnutrition

Summary: enhancing the anabolic effect of nutrition in critically ill patients by administering exogenous amino acids.

critically-ill patients admitted to the intensive care unit are invariably catabolic and are commonly undernourished. previous observational studies indicate that increased dietary administration of protein or essential amino acids might be associated with improved clinical outcomes. the investigators propose that the parenteral supplementation of intravenous amino acids in critically-ill patients will restore anabolic processes and that anabolism is associated with molecular markers of amino acid sensing and protein synthesis. the results from this study will establish biomarkers of anabolism (i.e., nutritional success) that can be used in future clinical trials on the use of amino acid supplementation in the critically-ill.

Eligibility criteria:
inclusion criteria: * mechanically ventilated adult patients (\>18 years old) admitted to icu with an expected icu dependency (alive and need for mechanical ventilation * vasopressor therapy, or mechanical circulatory support) at the point of screening of an additional 3 days, as estimated by the treating physician. exclusion criteria: * patients who are moribund (expected death within 48 hours) * expected to have life-sustaining treatments withdrawn in the next 3 days * those with a contraindication to enteral nutrition (en) * already on parenteral nutrition (pn) * those with acute fulminant hepatitis or severe chronic liver disease (child's class c) * patients on extracorporeal membrane oxygenation or carbon dioxide removal\* patients with organ transplantation * those with a broncho-pleural fistula * patients with documented allergies to any of the study nutrients or its excipients will be excluded. * patients requiring continuous renal replacement therapy or extracorporeal membrane oxygenation are excluded due to inability to accurately measure protein turnover.

Keywords: amino acids critically-ill catabolic nutrition anabolic
vitamin d deficiency and ovarian reserve among infertile patients

Conditions: Infertility

Summary: the role of vitamin d deficiency in female reproduction remains controversial. early retrospective studies were inconsistent regarding the effect of serum 25-oh vitamin d levels on pregnancy rates in women undergoing in vitro fertilization (ivf), whereas two retrospective studies postulated that vitamin d deficiency may negatively affect pregnancy rates with an effect mediated through the endometrium. taking into account that knock-out experiments have shown that vitamin d receptor null mice not only experience uterine hypoplasia but also impaired folliculogenesis, it might be hypothesized that vitamin d deficiency may have a detrimental effect on female ovarian reserve. this may be further supported by previous reports demonstrating that serum 25-oh vitamin d levels correlates with antimullerian hormone (amh) levels in women of advanced reproductive age. the aim of this study is to examine through a large set of prospectively recruited infertile women whether serum 25-oh-vitamin d levels is related with the 2 most widely accepted biomarkers of ovarian reserve: serum amh levels and antral follicle count (afc).


Eligibility criteria:
inclusion criteria: infertile women less than 42 years old, undergoing their first treatment cycle in our institution exclusion criteria: vitamin d supplements, taking medication for systematic disease or having potential iatrogenic (e.g. ovarian surgery, gonadotoxic therapy) or known genetic cause of ovarian loss

Keywords: infertility
assessment of periodontal therapy and biofilm management in breast cancer

Conditions: Breast Cancer; Gingivitis; Periodontal

Summary: objective: to evaluate the impact of chemotherapy on periodontal conditions, hematology, and salivary flow in patients with breast cancer and gingivitis, after basic periodontal therapy (bpt). methods: they were divided into patients with breast cancer and gingivitis (bc/g =20); and patients without cancer with gingivitis (g=20). clinical parameters \[plaque index (pi), bleeding on probing (bop), probing depth (ps), clinical attachment level (cal)\], hematological parameters (complete blood count), and salivary flow were evaluated at baseline, 6, 12 and 24 weeks.

objective: to evaluate the impact of chemotherapy on periodontal conditions, hematology, and salivary flow in patients with breast cancer and gingivitis, after basic periodontal therapy (bpt). methods: they were divided into patients with breast cancer and gingivitis (bc/g =20); and patients without cancer with gingivitis (g=20). clinical parameters \[plaque index (pi), bleeding on probing (bop), probing depth (ps), clinical attachment level (cal)\], hematological parameters (complete blood count), and salivary flow were evaluated at baseline, 6, 12 and 24 weeks.

Eligibility criteria:
- all patients were diagnosed with localized gingivitis (g) the inclusion criteria were: at least 15 teeth; no loss of attachment and probing depth ≤ 3mm; bleeding on probing ≥ 10% of sites, no radiographic bone loss. exclusion criteria: 1) systemic diseases (e.g. diabetes, cardiovascular diseases) or autoimmune diseases in addition to cancer; 2) patients with periodontitis; 3) use of any medication that could interfere with periodontal aspects; 4) smokers; 5) pregnant or lactating patients.

Keywords: breast cancer gingivitis periodontal therapy
effects of benfotiamine and age on endothelial function in people with diabetes

Conditions: Endothelial Dysfunction; Type 2 Diabetes Mellitus

Summary: the purpose of the study is to determine whether there are differences in postprandial endothelial function following a high-age(advanced glycation end-products) meal vs. a low-age meal. we also intend to investigate if the therapy with 1050mg benfotiamine for 3 days protects against the postulated deterioration of endothelial function after a high-age meal in people with type 2 diabetes mellitus.

ages are a heterogeneous group of compounds formed by the nonenzymatic reaction of reducing sugars with proteins, lipids and nucleic acids. diet has been recognized as an important exogenous source of ages. there is evidence for the implication of ages in the pathogenesis of diabetes-related complications, atherosclerosis, ageing processes or alzheimer´s disease. although, only little information exists about their effects in humans. the hypotheses of this study are that a high-age meal leads to a more important acute vascular dysfunction comparing to a low-age meal, and that a 1050mg/day benfotiamine therapy for 3 days has a protective effect on the endothelial function. twenty-one people with type 2 diabetes shall be investigated in a randomized, single-blinded (investigator), cross-over design (please compare design description).

Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus * age: 35-70 years exclusion criteria: * heart failure corresponding to nyha- class iii and iv * history of stroke * history of myocardial infarction * unstable angina pectoris * peripheral artery disease stadium iib and more * kidney disease (creatinine \> 1,8 mg/dl and/or creatinine clearance \ 200 mg/l) * malignant diseases * chronical alcohol consumption (more than 50 ml of highly concentrated alcohol or equivalents / day) * pregnancy or lactation * potentially child- bearing women without sufficient contraception (sufficient contraception is defined as the use of a contraceptive method that has an efficiency of over 99% (according to chmp/ewp/225/02)). a pregnancy test will be performed before the commencement of the study. * arterial hypotonia (blood pressure\ 159 mmhg and/or diastolic blood pressure \>99 mmhg * arterial hypertonia requiring more than three antihypertensive agents * advanced diabetes complications (subjects must have been investigated with regard to these complications maximum 6 months previously by a specialized physician) such as: * proliferative diabetic retinopathy * diabetic neuropathy requiring morphium derivatives * patients with an acute foot syndrome * hba1c \>10 % * participation to other studies within the previous 3 months

Keywords: endothelial dysfunction flow-mediated dilatation advanced glycation end products postprandial