Kornimate/medical-research-clean huggingface dataset:
electrical stimulation as an adjunctive therapy to increase vascular perfusion in people with pad or pvd

Conditions: PAD - Peripheral Arterial Disease; PVD- Peripheral Vascular Disease

Summary: the purpose of this study is to apply avazzia micro-current stimulation to patients with chronic, non-healing wounds to determine if this therapy is effective in perfusion and bacterial measurements.

investigators hope to learn if micro-current stimulation to a chronic, non-healing wound can be lead to healing. perfusion studies and bacterial measurements will be assessed before and after treatment on this cross-over study. avazzia microcurrent stimulation was applied to patients with chronic, non-healing wounds in malaysia and was presented at the international wound conference. in 2015 a poster presentation was presented with a 10-patient case series, and in august 2016, a presentation was made by dr. nair, keynote speaker about his 100- patient case series showing that the treatment was safe and effective. dr. nair followed this study with a 5-patient study looking at perfusion images using spy- luna imaging equipment. the 5-patient study looked at different methods of applying the therapy.

Eligibility criteria:
inclusion criteria: * patient has a chronic non-healing wound that has not healed in 30 days in their feet, legs, lower back or buttocks, but not in their hands because the hands will be used to verify equipment operation. * age ≥18 and ≤70 years * wound area is ≥0.5 cm2 and ≤22 cm2 * willing and able to comply with weekly visits to clinic (e.g., reliable transportation) exclusion criteria: * presence of an electrical implant such as a cardiac pacemaker or neural stimulator * patient is currently pregnant, possibly pregnant or breast-feeding user of any microcurrent device in the past six (6) months prior to enrollment in the study * patient is experiencing a medical emergency * patient is diagnosed with neuropathy from sources other than diabetes, such as heavy metal, xenobiotic toxicity * patient is diagnosed with charcot-marie-tooth or similar genetically inheritable neuropathic disease(s) * patient is diagnosed with end-stage kidney disease/dialysis or severe kidney insufficiency * patient is diagnosed with malignancies (cancers) undergoing treatment
cost and effectiveness of pressurized intraperitoneal aerosol chemotherapy in patients with peritoneal carcinoma.

Conditions: Evaluate the Cost of a PIPAC Procedure and the Associated Hospital Stay in France

Summary: the presence of peritoneal carcinomatosis indicates a neoplastic disease evolved. without intervention, the prognosis is poor with survival of only a few months. standard treatment is based on systemic chemotherapy, however, the pharmacokinetics of drug delivery to the peritoneum is poor, with limited efficacy compared to other metastatic sites such as the liver or lung. when the carcinomas are is resectable, selected patients can benefit from targeted therapeutic approaches combining peritonectomy and hyperthermic intraperitoneal chemotherapy (hipec), offering a significant improvement in survival. a new surgical technique has been developed for patients with unresectable chemotherapy intraperitoneal aerosol spray (pipac). the objective is to improve the survival time, quality of life but can also make pc resectable and therefore accessible to complete excisional surgery. the cost of this treatment is not yet fully assessed in france. the main objective of this study is to assess the real cost of pipac in order to allow its dissemination.


Eligibility criteria:
inclusion criteria: * adult patients * patients treated with pipac and monitored for peritoneal carcinoma * patients informed exclusion criteria: * patients opposition
preoperative ketorolac for pain control in scleral buckle surgery

Conditions: Pain

Summary: the scleral buckle surgery is an effective way in treating retinal detachment (rd) patients. retrobulbar block has been proved effective in scleral buckle surgery. though retrobulbar anesthesia saves operative time and money compared to general analgesia, the intraoperative pain is frequent and a proportion of postoperative pain is often ignored. ketorolac has been demonstrated to be a preemptive analgesia in other diseases such as adenotonsillectomy, posterior lumbar spinal fusion, laser-assisted subepithelial keratectomy (lasek), and so forth. the aim of the investigators study is to determine the safety and preemptive analgesic effect of ketorolac in the perioperative pain control of patients undergoing rd surgery under retrobulbar anesthesia.


Eligibility criteria:
inclusion criteria: 1. consent of the patient or legal guardian 2. 18 years or above 3. normal height and weight 4. asa class i, ii 5. elective surgery 6. surgery time within 60min 7. understanding of the verbal numerical rating score (0-10) exclusion criteria: 1. history of ocular surgery, trauma or infection 2. intraoperative complications 3. glaucoma or ocular hypertension (\> 20 mmhg) 4. diabetic retinopathy 5. diagnosis of asthma or coagulopathy 6. chronic pain syndromes 7. history of peptic ulceration, liver or hematologic disease 8. history of chronic use of analgesics, sedatives, opioids or steroids 9. history of drug or alcohol abuse 10. history of systemic disease 11. sexually transmitted disease (std) 12. pregnancy, lactation; 13. cognitive impairment or psychiatric illness;
early human milk fortification after early, exclusive, enteral nutrition in very preterm infants

Conditions: Prematurity; Light-For-Dates; Enteral Feeding Intolerance

Summary: in this proposed clinical trial, the investigators will randomize 80 very preterm (vpt) infants to receive either early (between day 4 and 7) or delayed (between day 10 and 14) fortification and determine if providing early protein supplementation through early fortification results in higher ffm-for-age z scores and more diversity in the gut microbiome.


Eligibility criteria:
inclusion criteria: * gestational age 29 to 33 weeks of gestation * birth weight \< 1800 g * postnatal age \< 96 hours exclusion criteria: * small for gestational age (\<5th percentile) * major congenital/chromosomal anomalies * terminal illness needing withhold or limit support
risk factors for hospitalization and transfusion criteria in patients with dengue virus infection

Conditions: Dengue; Dengue Fever; Dengue Fever With Warning Signs

Summary: this 3-year prospective observational study aims to identify clinical and laboratory risk factors associated with hospitalization in patients with confirmed dengue virus infection. it also seeks to analyze real-world transfusion practices and their outcomes. the study will be conducted in a second-level hospital in northern mexico and will follow patients from emergency department entry to clinical resolution or hospital discharge.

this study will prospectively follow patients over 3 years to determine the relationship between clinical/laboratory variables and outcomes such as hospitalization and transfusion need. it seeks to improve understanding of real-world decision-making in transfusions for dengue-related thrombocytopenia and refine current hospitalization criteria based on locally observed predictors. patients will be enrolled consecutively at emergency departments or outpatient clinics with confirmed dengue infection. clinical data (fever duration, bleeding signs, vomiting, abdominal pain, platelet count, hematocrit) and transfusion records will be collected and analyzed to identify independent predictors using multivariate logistic regression.

Eligibility criteria:
inclusion criteria: * patients aged ≥5 years * laboratory-confirmed dengue infection (ns1, igm, or pcr) * first contact at emergency or outpatient services * informed consent signed by the patient or legal guardian exclusion criteria: * co-infection with other arboviruses or covid-19 * pre-existing hematologic or oncologic disease * refusal to sign informed consent

Keywords: dengue hospitalization transfusion hemorrhagic fever thrombocytopenia mexico
microdermabrasion for acne

Conditions: Acne Vulgaris

Summary: the purpose of this research project is to study the effect of micordermabrasion to try to improve the appearance of facial acne. the microdermabrasion machine is a hand-held device that directs pressurized aluminum oxide crystals at its target accompanied by a suction device. it is not yet clear how much improvement can be seen with these treatments or exactly how the skin's response causes these improvements. in this study, we are interested in learning how well microdermabrasion works to improve the symptoms of acne.

acne vulgaris remains among the most common cutaneous disorders, impacting the vast majority of people at some point during their lives. it is associated with significant psychosocial morbidity, and there remains the need for efficacious and low risk therapeutic options. microdermabrasion is a technique combining abrasion and negative pressure used primarily in the treatment of aging skin. it has also been proposed to improve acne presumably through a comedolytic effect. negative pressure and abrasion may remove debris from follicular orifices that act as a nidus for acne lesions. many physicians and spas use micordermabrasion as a treatment for acne, however, there has never been a randomized controlled trial to substantiate this practice. we propose to evaluate the efficacy of microdermabrasion in the treatment of inflammatory acne. we will use the bellamed microdermabrasion system produced by bella products or the altair diamondtome system.

Eligibility criteria:
inclusion criteria: * age 13 years or older of either gender and of any racial/ethnic group. * presence of clinically evident acne vulgaris of the facial skin. * subjects must be in generally good health. * subjects must be able and willing to comply with the requirements of the protocol. * subjects must live within a reasonable driving distance of ann arbor, michigan, and/or be able to attend all of the scheduled appointments during the study. exclusion criteria: * oral retinoid use within 6 months of entry into the study. * systemic acne therapies (oral antibiotics) within 4 weeks of entry into the study. * topical acne therapies (retinoids,antibiotics) within 2 weeks of entry into the study. * laser or superficial chemical peels at the sites to be treated within 3 months of entry into the study. * subjects with a history of dermabrasion or laser resurfacing at the sites to be treated. * use of topical lipid absorbing substances (clinac ac) within 2 weeks of entry into the study. * non-compliant subjects. * subjects with a significant medical history or concurrent illness/condition which the investigator(s) feel is not safe for study participation. * subjects using alcohol-based topical solutions or "exfoliating" agents within 2 weeks of entry into the study. * subjects with a history of very frequent herpes simplex infections of the face or with clinical evidence of active herpes simplex infections. * pregnant or nursing females.

Keywords: acne microdermabrasion
evaluation of preoperative n1539 in colorectal surgery

Conditions: Pain, Postoperative

Summary: the primary objective of this study is to evaluate the safety and tolerability of preoperative dosing of n1539 30 mg in subjects undergoing colorectal surgery, including clinical laboratory tests, wound healing evaluation, incidence of anastomotic leaks, and incidence of adverse events (aes) and serious aes (saes).


Eligibility criteria:
inclusion criteria: * voluntarily provide written informed consent. * be planned to undergo primary (no repeat procedures) open or laparoscopic colorectal surgery (laparoscopic expected to require a ≥ 5 cm incision) with bowel resection and/or anastomosis. * asa physical status category 1, 2, or 3. * female subjects not pregnant or planning/attempting to become pregnant, not lactating; or commits to the use of an acceptable form of birth control for the duration of the study. * have a body mass index \<40 kg/m\^2 exclusion criteria: * have a known allergy or hypersensitivity to any study treatment. * planned surgical procedure includes a resection beyond the peritoneal reflection, is related to an acute bout of diverticulitis, or is associated with an emergency procedure. * have a history of myocardial infarction within the preceding 12 months. * have, as determined by the investigator or the sponsor's medical monitor, a history or clinical manifestations of significant condition that would preclude participation. * have active or recent (within 6 months) gastrointestinal ulceration or bleeding, with exception of events related to an ulcerative colitis diagnosis. * have a known bleeding disorder which may be worsened with the administration of an nsaid. * be currently receiving treatment with oral meloxicam (mobic®) or another nsaid within 48 hours prior to surgery. * have previously received n1539/iv meloxicam or received any investigational product within 30 days before dosing with study medication. * have undergone or be expected to undergo radiation therapy, chemotherapy, or other biological therapy for cancer treatment, within 60 days prior to screening through last follow-up.

Keywords: colorectal surgery pain analgesia n1539 phase 3b
incidence of metabolic syndrome and thyroid dysfunction in patients with major depressive disorder

Conditions: Major Depressive Disorder; Metabolic Syndrome; Thyroid Dysfunction

Summary: aim 1 is to study prevalence and 1 year incidence of metabolic syndrome in major depressive disorder and factors correlation. aim 2 is to study prevalence and 1 year incidence of thyroid dysfunction in major depressive disorder and factors correlation.


Eligibility criteria:
inclusion criteria: * patient with major depressive disorder * age over 18 years exclusion criteria: * subject who cannot give information.

Keywords: major depressive disorder metabolic syndrome thyroid dysfunction incidence
study evaluating etanercept in patients with ankylosing spondylitis

Conditions: Ankylosing Spondylitis

Summary: this study will assess the efficacy of etanercept for the treatment of ankylosing spondylitis (as).


Eligibility criteria:
inclusion criteria: * diagnosis of as, as defined by modified new york criteria for ankylosing spondylitis, aged between 18 and 70 years of age. * basdai greater than or equal to 40 (all scores on a scale of 0 to 100). * negative result of serum human chorionic gonadotropin (hcg) pregnancy test taken at screening in all women except those surgically sterile or at least 1 year postmenopausal. exclusion criteria: * complete ankylosis (fusion) of spine. * previous receipt of etanercept, antibody to tnfα, or other tnfα inhibitors. * use of disease modifying antirheumatic drugs (dmards) other than hydroxychloroquine, sulphasalazine, and methotrexate within 4 weeks of baseline. patients treated with hydroxychloroquine, sulphasalazine, and methotrexate may continue these drugs during this study but doses must be held stable for 4 weeks before baseline examination and for the duration of the study.
xrp9881 in combination with trastuzumab in metastatic breast cancer

Conditions: Breast Neoplasms

Summary: the primary objective of the study is to assess the activity of xrp9881 in combination with trastuzumab. the secondary objectives are safety and pharmacokinetic interaction


Eligibility criteria:
inclusion criteria: * metastatic breast cancer (mbc) * her2 (human epidermal growth factor receptor 2) positive: fish (fluorescent in situ hybridization) positive or ihc (immunohistochemistry) 3+ * measurable disease according to response evaluation criteria in solid tumors (recist) * adequate organs functions exclusion criteria: * more than one previous chemotherapy regimen for metastatic disease * cardiac dysfunction

Keywords: cancer breast metastatic breast cancer
acute effects of intravenous iron on oxidative stress and endothelial dysfunction in non-dialysis ckd

Conditions: Renal Anemia; Iron Toxicity; Oxidative Stress; Endothelial Dysfunction

Summary: the purpose of this study is to investigate the effects of acute intravenous iron administration on the endothelial function in non-dialysis chronic kidney disease stages g3-g5 patients with anemia and iron deficiency, in relation to changes in oxidative and nitrosative status.


Eligibility criteria:
inclusion criteria: * chronic kidney disease stages g3-g5 (defined according to kdigo criteria); * anemia (defined according to kdigo criteria) and iron deficiency defined as serum ferritin \< 100 ng/ml and/or tsat \< 20% (kdigo). exclusion criteria: * contraindications of intravenous iron therapy: iron allergy, active infection, hemochromatosis, iron overload (serum ferritin \> 500 ng/ml and/or transferrin saturation \> 50%); * treatment with iron and erythropoiesis-stimulating agents (at the time of recruitment and 6 months previously); * active smoker status; * antioxidant food supplements treatment in the last 3 months; * clinically manifest bleeding; * another cause of anemia (hemoglobinopathies, vitamin b12 and/or folic acid deficiency suggested by the megaloblastic peripheral blood smears's appearance, multiple myeloma and other paraproteinemias); * severe anemia (hb \< 7 g/dl); * baseline fmd \< 7% (the existence of atherosclerosis which limits arterial reactivity); * cancer (currently or in the past 6 months); * hepatopathies (increased serum transaminases ≥ 3 x normal value) or hepatic impairment ≥ grade child b; * autoimmune disorders or significant inflammation (as defined by c-reactive protein \> 5 mg/l); * pregnancy or lactation; * participation in other clinical trials over the upast 3 months; * patient unwillingness.

Keywords: ckd, anemia, iron, endothelial dysfunction, oxidative stress
gender dysphoria and transition

Conditions: Gender Dysphoria

Summary: persons with gender dysphoria present the difficulties of access to health care. little time is devoted to education of health professionals about the care of transgender persons. according to the proposal of the french ministry of social affairs and health there is a need to increase knowledge in this area and to improve the care of transgender people including prevention and screening. similarly, little is known about social and medical needs of the transgender population. this project proposes to illustrate gender dysphoria through testimonies of transgender people with the aim to increase the investigator's understanding aout the needs and the desires of this population and to describe the process of medical and social transition.


Eligibility criteria:
inclusion criteria: * person affiliated to a social security system * person having received complete information on the organisation of the research and having signed the informed consent * person having carried out a prior clinical examination adapted to the research * age\> 18 years * diagnosis of gender incongruence (dysphoria) according to the international classification of diseases, revision 11 exclusion criteria: * severe, uncontrolled psychiatric or somatic illness * substance and alcohol addiction * pregnancy
impact of very low nicotine content cigarettes in a complex marketplace

Conditions: Tobacco Smoking; Nicotine Dependence

Summary: this project will examine the impact of very low nicotine content (vlnc) cigarettes in a complex tobacco and nicotine product marketplace. we will compare the number of cigarettes smoked and cigarette-free days in an experimental marketplace that contains vlnc cigarettes versus normal nicotine content (nnc) cigarettes.

this randomized, open label, controlled, multi-site study will simulate a "real world" tobacco environment by providing participants access to an experimental marketplace where they will be given vouchers for a specified number of points that can be exchanged for study cigarettes (varying in nicotine content described below) and non-combusted tobacco/nicotine products (smokeless tobacco, snus, electronic cigarette, medicinal nicotine replacement) and at the end of the study can exchange unspent points for money. subjects (n=200 in each group) will be randomly assigned to: 1) very low nicotine content cigarettes (vlnc; 0.4 mg nicotine/g tobacco) along with non-combusted tobacco/nicotine products or 2) normal nicotine content cigarettes (nnc; 15.8 mg nicotine/g tobacco) along with non-combusted tobacco/nicotine products. smokers will undergo an orientation visit for screening and then enter a three phase experimental trial: 1. phase 1 - baseline: two week baseline assessment period during usual brand cigarette smoking. 2. phase 2 - marketplace adaptation: two week period where subjects have access to the marketplace that provides their preferred usual brand cigarettes and selected non-combusted tobacco products to allow the subject to adjust to the marketplace prior to randomization; 3. phase 3 - intervention: randomization to a marketplace with access to either vlnc or nnc cigarettes plus non-combusted products for a 12 week period. biomarker samples are collected at baseline, end of phase 2 and end of week phase 3 (week 12).

Eligibility criteria:
inclusion criteria: 1. male or female; 2. 18/21 (legal age to purchase tobacco at site); 3. biochemically confirmed smoker. exclusion criteria: 1. unstable health condition; 2. unstable medications; 3. pregnant or nursing.

Keywords: reduced nicotine cigarettes alternative nicotine products biomarkers of tobacco exposure
deficits in emotion regulation skills as a maintaining factor in major depressive disorder

Conditions: Major Depressive Disorder

Summary: the primary aim of the study is to evaluate the efficacy of a systematic training of general affect regulation skills (art) on the reduction of depressive symptom in individuals meeting criteria for major depressive disorder (mdd).

deficits in general emotion regulation skills have been shown to be associated with various mental disorders. thus, general affect-regulation training has been proposed as promising transdiagnostic approach to the treatment of psychopathology. in the present study, we aimed to evaluate the efficacy of a general affect-regulation as a stand-alone, group-based treatment for depression. for this purpose, we randomly assigned 218 individuals who met criteria for major depressive disorder (mdd) to the affect regulation training (art), to a waitlist control condition (wlc), or to a condition controlling for common factors (cfc). the primary outcome was the course of depressive symptom severity as assessed with the hamilton rating scale for depression and the beck depression inventory. differences between groups will be analyzed with the help of multi-level analyses. to clarify mechanisms of change we will test whether changes in emotion regulation skills will mediate potential differences between conditions regarding change of depressive symptoms. as secondary goal, the study will try and clarify whether participating in art might augment the efficacy of subsequent individual cognitive-behavioral therapy.

Eligibility criteria:
inclusion criteria: * diagnosis of mdd according to dsm-iv criteria as the primary diagnosis * age 18 and above * sufficient german language skills exclusion criteria: * high risk of suicide * indication of substantial secondary gain * currently in psychotherapeutic treatment with an institution/professional other than those involved in the study * co-occurring psychotic, bi-polar, and/or substance disorders * organic brain disorder(s), severe medical condition, and/or severe cognitive impairment that impedes ability to participate in the study or treatment

Keywords: depression emotion regulation affect regulation skills randomized controlled trial mediation