Kornimate/medical-research-clean huggingface dataset:
multicentric prospective randomized trial on surgery versus standard medical care in type 2 diabetic patients bmi 30-35

Conditions: Diabetes Mellitus

Summary: 200 type 2 diabetic patients -bmi between 30-35- will be submitted to bariatric surgery (biliopancreatic diversion bpd or gastric bypass gbp ) and 100 will receive standard medical treatment. subjects will be monitored during a 5 year period to assess the effects of the surgical procedures on diabetes resolution and control at 1, 3 and 5 years.

the study is a multicentric prospective 2-arm randomized controlled trial. only centers with at least 50 bariatric surgeries performed during the time window january 2007 and september 2008 will be allowed to participate in the study. each collaborating center participating in the study will perform only one type of surgical procedure (gbp or bpd), depending on which one it is more familiar with. patients will be randomly assigned with a 2 to 1 ratio to receive either bariatric surgery (bs) (either gbp or bpd) or standard antidiabetic care (ac). the randomization will be centralized in the coordinating center. patients assigned to bs will undergo gbp or bpd, depending on each collaborating center. recruitment will continue, independently of the number of recruited patients per center, until the target of 200 gbp+bpd patients, and 100 ac patients will be attained. after one year since enrollment, patients in ac group will be offered the choice to undergo one of the two surgical procedures, and then will follow the same protocol study as the other surgical patients. in addition, each collaborating center will be responsible for selecting one diabetic subject for each operated patient, matched as closely as possible with the patients assigned to surgical therapy, from the local population in medical treatment. these patients will serve as controls for long term mortality and morbidity.

Eligibility criteria:
inclusion criteria: * bmi ≥30 and ≤34.9 kg/m2 * age between 35 and 70 years * duration of diabetes ≥ 5 years * poor glycemic control (i.e., hba1c ≥ 8%) in spite a medical antidiabetic therapy in accordance with good clinical practice (gcp) * presence of significant co-morbidities or complications (such as dyslipidemia, arterial hypertension, impaired renal function, neuropathy, retinopathy, cvd) exclusion criteria: * specific contraindication to obesity surgery or gbp or bpd, including any gastric alteration specifically contraindicating gbp * hba1c \< 8% * positive autoantibodies anti-pancreas islet * serum c-peptide \< 0.5 ng/ml * pregnancy * medical conditions requiring acute hospitalisation * severe diabetes complications or associated medical conditions (such as blindness, end-stage renal failure, liver cirrhosis, malignancy, chronic congestive heart failure * recent (within preceding 12 months) myocardial infarction, stroke or tia * unstable angina pectoris * psychological conditions which may hamper patient's cooperation * geographic inaccessibility * any condition which, in the judgement of the investigator, may make risky the participation in the study or bias the results

Keywords: type 2 diabetes mellitus
ketamine infusion for comorbid ptsd and chronic pain

Conditions: PTSD; Chronic Pain

Summary: the purpose of the study is to investigate the effectiveness of low dose iv ketamine infusion in the treatment of patients with ptsd and comorbid chronic pain. hypothesis: a single ketamine infusion should be associated with significantly greater reduction in core ptsd symptom levels after the treatment and such an effect is not only due to its analgesic properties but also through unknown mechanism of action that maybe related to nmda/ampa receptor modulation.

to date, treatment options (i.e. psychotherapy, antidepressant medications) for patients with ptsd, are relatively few, and considering their limited efficacy, novel therapies have gained interest among researchers and treatment providers alike. among patients with chronic pain about one third suffer from comorbid ptsd, which further complicates their already challenging pharmacological regimens. low dose ketamine infusion has shown promise in ptsd, and in treatment of chronic pain, however they have not been studied in comorbid population and under rigorous control conditions. the investigators compared the effects of a single dose of either ketamine (0.5 mg/kg) or ketorolac (15 mg) over a 40-minute of iv infusion in chronic pain patients with and without ptsd, in double blind, randomized study. measures were collected before, during, 1 day and 7 days after the infusion.

Eligibility criteria:
inclusion criteria: veterans with chronic pain as defined by having any chronic pain beyond 6 months in duration with and without ptsd diagnoses (participants must meet dsm-v criteria for current post-traumatic stress disorder (ptsd) and have received a diagnosis of ptsd greater than or equal to 3 months prior to assessment); they also will be either free of concomitant use of psychotropic and/or pain medications for at least 6 weeks or on stable doses of those medications within the last 6 weeks prior to randomization and for the duration of the study; if applicable, current frequency and duration of psychotherapy sessions must remain stable for at least 6 weeks prior to beginning of the study. exclusion criteria: inability to speak english, inability or unwillingness to provide written informed consent; moderate-to-severe cognitive impairment (mini-mental state examination scores\<20 administered by a trained clinician); current or lifetime history of psychotic or bipolar disorder; current bulimia or anorexia nervosa, alcohol abuse or dependence in the previous 3 months; serious unstable medical illness or sleep apnea; htn, prolonged qt interval, peptic ulcer disease or recent history of gi-bleed, renal insufficiency, active substance use disorder, active suicidal or homicidal ideation on presentation; pregnancy (confirmed by baseline lab test), the initiation of female hormonal treatments within 3 months of screening, or inability or unwillingness to use a medically accepted contraceptive method for the duration of the study.

Keywords: ptsd chronic pain ketamine infusion
kinesiotaping and stretching on skm and upper trapezius muscle in tmd patients

Conditions: TMJ Disc Disorder; Myofascial Pain

Summary: purpose: this study determined the effects of kinesiotaping and stretching on pain, cervical joint range of motion and functional status in patients with myofascial pain due to temporomandibular joint disorder. methods: 33 patients with myofascial pain due to temporomandibular joint disorder were included in the study. the patients were divided into three groups by simple randomization (kinesiotaping group, stretching group and control group). patients in the kinesiotaping and stretching groups received application for their upper trapezius and sternocleidomastoid muscles twice a week for two weeks by the same physiotherapist. no application was made to the control group. cervical joint range of motion, muscle strength and pain were evaluated. additionally, algometry tests and functional evaluation were performed. the tests were performed in the kinesiotaping and stretching groups before the applications and at the end of week 1 and week 2, on the other hand control group evaluated before the application and at the end of week 2.

this study is my master's thesis that i conducted in 2018. our prospective clinical study was approved by the non-interventional ethics committee. the study was conducted at dentistry prosthetic odontotherapy outpatient clinic between february 2018 and april 2018. volunteering 33 patients between the ages of 18 to 60 years and who applied clinics and were diagnosed with myofascial pain due to tmj disorder according to research diagnostic criteria for temporomandibular disorders (rdc/tmd) classification were included in the study. the patients were divided into groups using simple randomization method. there are 11 patients in groups. blinding was ensured by patients and dentist were unaware the type of physiotherapy treatment application. patient evaluation was repeated 3 times: before the treatment, at the end of week 1, and at the end of week 2 of the treatment. in our study, the effects of conservative treatment options used in 'treatment of tmd on 'disease symptoms were examined compared with the control group. a 2-week follow-up was foreseen for the acute impact outcomes of the study.

Eligibility criteria:
inclusion criteria: * age between 18 and 60 years * myofascial pain according to rdc/tmd * natural posterior occlusion and volunteering * being informed and signing the consent to participate in the research. exclusion criteria: * presence of dentofacial anomalies * arthralgia * disk displacement * general inflammatory connective tissue diseases (e.g. rheumatoid arthritis) * psychiatric disease * tumor * orofacial disease symptoms (neuralgia, migraine, etc.) * local skin infection * using regular analgesic * fibromyalgia * history of tmj-related surgery * findings of allergy related to kinesiotape.

Keywords: temporomandibular pain kinesiotape stretching
mathematical model for the human menstrual cycle, endocrinological diseases and fertility treatment-paeon

Conditions: Polycystic Ovary Syndrome; Endometriosis; Hyperprolactinemia

Summary: development of a bio-mathematical model of the human female cycle

from hormonal measurements throughout 1-2 menstrual cycles in women with and without endocrinological pathology a mathematical model of the human menstrual cycle will be generated. the model will serve to predict development of the cycle including ovulation as well as to better understand the pathophysiology of endocrinological disorder. in a second step current treatment protocols for fertility treatment will be integrated into the model in order to optimize treatment outcome.

Eligibility criteria:
inclusion criteria: - women during their reproductive phase, no hormonal therapy exclusion criteria: - amenorrhoae

Keywords: menstrual cycle dynamics pcos hyperprolactinemia endometriosis infertility
ocular surface dry eye microbiome

Conditions: Dry Eyes

Summary: the investigators seek to characterize the identity of all microorganisms residing on the eye's surface (conjunctiva) in healthy eyes and those with dry eye syndrome, using a combination of analyses. dry eye disease is thought to have an inflammatory basis and in the vast majority of cases the cause of the chronic inflammatory condition is unknown.


Eligibility criteria:
inclusion criteria: * dry eye syndrome with osdi score greater than 60 * control group with osdi score less than 30 exclusion criteria: * recent history of contact lens wear * use of topical antibiotics or prescription eye medication in past 6 months * penetrating ocular surgery in the last 12 months * age less than 18 years

Keywords: dry eye
assessment of ketamine and propofol sedation during lisa method (less invasive surfactant administration)

Conditions: Premature Neonate

Summary: respiratory distress syndrome (rds) caused by surfactant deficiency remains one of the major reasons of morbi-mortality in preterm infants and affects 85% of preterm babies born less than 32 week gestational age (wga). the strategy to manage rds relies on the use of surfactant and non-invasive nasal ventilation, to limit tracheal mechanical ventilation. during recent years, surfactant administration through a thin catheter in spontaneously breathing preterm used in association with continuous positive airway pressure (cpap) has emerged as a new approach for treating neonates with respiratory failure. the main objectives of less invasive surfactant administration (lisa) are to avoid endotracheal mechanical ventilation and its side effects including bronchopulmonary dysplasia. the lisa premedication procedure still under debate, because only 1 trial use analgesia or sedation during procedure. this reflects neonatologists concerns about side effects (apnea and the need for mechanical ventilation) of this premedication. this study aims to optimize sedation during lisa procedure by evaluating pain score with ketamine or protofol sedation, in neonatal intensive care unit (nicu) patients with rds.

systematic reviews of the prospective studies performed suggest that among preterm infants, the use of lisa was associated with the lowest likelihood of the composite outcome of death or bronchopulmonary dysplasia (bpd) at 36 weeks' postmenstrual age when compared with the other ventilation strategies for preterm infants. further studies are needed to optimize the indications and identify adequate strategies for premedication that preserve respiratory function and which limits pain and cardio-respiratory instability associated with laryngeal exposure without increasing risks of complications. according to a recent european survey, only 48% of neonatologists perform lisa with sedation. in a recent retrospective study, dekker showed a more favorable comfortneo score with propofol versus without, similar rates of intubation during lisa. ketamine infusion has been used in several nicus with few reported effects on respiratory function, but without publication. no prospective studies exist on lisa premedication. this study aims to optimize sedation during lisa in nicu patients with rds. comparing ketamine and propofol sedation with rate of mechanical tracheal ventilation from the start of the lisa procedure up to 2 hours of life, in the nicu of arnaud de villeneuve university hospital of montpellier (france).

Eligibility criteria:
inclusion criteria: * infant born below 30 wga with rds treated by cpap requiring surfactant * available iv line * admission to the nicu of montpellier university hospital centre in the first 24 hours of life exclusion criteria: * maternal general anesthesia

Keywords: less invasive surfactant administration (lisa) sedation rds treated by cpap requiring surfactant sedation during intra tracheal surfactant administration by the lisa method available intravenous line
efficacy study of pilocarpine hcl ophthalmic solution (agn-190584) in participants with presbyopia

Conditions: Presbyopia

Summary: a study to evaluate the efficacy, safety, and pharmacokinetics of pilocarpine hydrochloride (hcl) ophthalmic solution (agn-190584) when administered bilaterally, once daily for 30 days in participants with presbyopia.


Eligibility criteria:
inclusion criteria: - subjective complaints of poor near vision that impact activities of daily living exclusion criteria: * history of cataract surgery, phakic intraocular lens surgery, corneal inlay surgery, radial keratotomy, or any intraocular surgery * use of any topical ophthalmic medications, including artificial tears other than the study medications during the study * use of temporary or permanent punctal plugs or history of punctal cautery in one or both eyes * corneal abnormalities (including keratoconus, corneal scar, fuchs' endothelial dystrophy, guttata, or edema) in either eye that are likely to interfere with visual acuity * narrow iridocorneal angles (shaffer grade ≤2 or lower on gonioscopy examination), history of angle-closure glaucoma, or previous iridotomy * diagnosis of any type of glaucoma or ocular hypertension
study comparing cyclosporine dose reduction vs. cyclosporine elimination in kidney transplant recipients taking sirolimus

Conditions: Kidney Failure; Graft vs Host Disease

Summary: compare kidney function as measured by calculated creatinine clearance (using the method by nankivell)1 at 12 months after transplantation in subjects receiving induction therapy with cyclosporine microemulsion (csa) and rapamune followed by csa dose reduction (group i) with subjects receiving induction therapy with csa and rapamune followed by csa discontinuation (group ii).


Eligibility criteria:
inclusion criteria: * subjects with end-stage renal disease scheduled to receive a primary or secondary renal allograft from a cadaveric donor, from a living-unrelated donor, or a living-related hla-mismatched donor. subjects must be at least 18 years of age. exclusion criteria: * subjects with active major infection, including active hepatitis b or c infection, decreased platelets, elevated lipids, or multiple organ transplants.

Keywords: kidney failure transplant
the effect of exercise on serum levels of collagen and proteoglycan in patients with knee osteoarthritis

Conditions: Osteoarthritis, Knee

Summary: the aim of efex-oa-02 is to explore how running, cycling, exercise simulation and resting acutely influence collagen and proteoglycan homeostasis in oa, as reflected by changes in collagen and proteoglycan levels in urine and serum.


Eligibility criteria:
inclusion criteria: 1. cumulated osteoarthritis kellgren-lawrence radiological grade of at least 2 in the tibio-femoral joints diagnosed by screening x-ray. 2. 40 to \< 75 years of age at time of signing the informed consent. 3. body weight \> 50 and \< 100 kg and bmi in the range 18.5-35 kg/m2 . 4. male or female. 5. able to attend all four study sessions and comply with the dietary and activity restrictions. 6. able to provide informed consent exclusion criteria: medical conditions: 1. osteoarthritis kellgren-lawrence radiological grade of 4 in one or both knees. 2. cumulated osteoarthritis kellgren-lawrence radiological grade no higher than 1. 3. history of arthroscopy or intra-articular administration of corticosteroids or hyaluronic acid into the target knee within 6 months before screening. 4. previous arthroplasty of knee or hip. 5. intention to have major surgery during the timeframe of the study. 6. secondary oa related to e.g. any known trauma including cruciate ligament tears, meniscus tears and cartilage damage, dysplasia, aseptic osteonecrosis, acromegaly, paget disease, stickler syndrome, hemochromatosis, gout, chondrocalcinosis (pseudogout). 7. current treatment with beta-receptor adrenergic antagonists (beta-blockers), mao inhibitor, systemic corticosteroid treatment in doses equivalent to \> 10 mg prednisolone per day, or vitamin k antagonists, new oral anticoagulants, fractionated and non-fractionated heparin. 8. active systemic infection. 9. active systemic inflammatory or autoimmune disease. 10. any sign of previous or current cardiovascular disease. 11. not currently an active athlete or highly trained individual. other exclusion criteria: 1. legal incapacity or limited legal capacity. 2. inability to communicate or cooperate with the investigator or to comply with the requirements of the entire study. 3. categorized as being very difficult to draw blood from, as evaluated by the investigator. 4. current alcohol abuse and/or inability to refrain from intake of alcoholic beverages for 24 hours prior to the study intervention. 5. other factors, e.g. self-reported drug abuse, which in the opinion of the investigator may interfere with the performance of the study. 6. site staff, study staff members and study staff family members. 7. other concomitant disease compromising or otherwise significantly affecting ecm turnover in the opinion of the investigator.
tumor necrosis factor inhibition in focal segmental glomerulosclerosis and treatment resistant minimal change disease

Conditions: FSGS; MCD; Focal Segmental Glomerulosclerosis; Minimal Change Disease

Summary: adalimumab, a treatment which blocks tumor necrosis factor (tnf), was tested to see if it changed levels of urine biomarker levels, tissue inhibitor of metalloprotease-1 (timp1), and monocyte chemoattractant protein-1 (mcp1). results may help develop individualized treatment options for future patients with tnf-driven focal segmental glomerulosclerosis (fsgs) or minimal change disease (mcd).


Eligibility criteria:
inclusion criteria: * kidney biopsy confirmed focal segmental glomerulosclerosis (fsgs) or minimal change disease (mcd) * for minimal change disease patients only, history of resistance to corticosteroid therapy * increased urinary excretion of biomarkers of tumor necrosis factor (tnf) activation (mcp1/cr and/ or timp1/cr) at study screening * egfr\>30 ml/min/1.73 m2 at screening * urine protein:creatinine ratio ≥1.5 g/g at screening * weight \>15 kg * stable therapy with angiotensin converting enzyme inhibitors, angiotensin receptor blockers, and oral immunosuppression agents for at least 30 days prior to enrollment * birth control use in females of child bearing potential * informed consent and assent if applicable exclusion criteria: * kidney or other solid organ or bone marrow transplant recipient * allergy or intolerance to investigational agent * secondary focal segmental glomerulosclerosis (fsgs) * severe obesity * live virus vaccine in the past 3 months * malignancy, current or in the past 5 years * active local or systemic bacterial, fungal or viral infection * active or latent hepatitis b, hepatitis c, hiv, or tuberculosis * history of demyelinating disease, e.g. multiple sclerosis or guillain-barre * history of heart failure * active liver disease * systemic lupus erythematosus or ana \> 1:80 * history of inflammatory bowel disease, e.g. ulcerative colitis or crohns disease * cyclophosphamide in past 90 days, rituximab in the past 180 days * pregnancy or nursing * blood white blood cell count \<4,500/mm3; hg \<9 g/dl; platelet count \<150,000/mm3 at enrollment. - use of an erythropoiesis stimulating agent will not be an exclusion criterion. * concurrent use of interleukin-1 antagonist (anakinra), other tnf blocking agent, methotrexate or abatacept * diabetes mellitus

Keywords: kidney disease minimal change disease nephrotic syndrome focal segmental glomerulosclerosis fsgs