Kornimate/medical-research-clean huggingface dataset:
targeting the gut microbiome to investigate the pathways of progression from obesity to metabolic diseases in an at-risk population.

Conditions: Obesity; Insulin Resistance

Summary: studies of the human gut microbiome have suggested that treatment or prevention aimed at the obese microbiome could influence the development of obesity-associated metabolic disturbances. the objective of this project is to explore if a dietary intervention in 60 obese women with the probiotic lactobacillus paracasei ssp paracasei f19 or flax seed fibres targeting the gut microbiome, can reduce insulin resistance, low-grade inflammation or dyslipidaemia, and to explore the interaction between the human genome and the gut microbiome. the study is based on the following hypotheses: * treatment with the probiotic lactobacillus paracasei ssp paracasei f19 and flax seed fibres will lower the metabolic risk profile in the intervention groups compared with placebo. * the effect on the metabolic risk markers can be correlated with changes in the gut microbiota (measured in faeces). after completion of the dietary intervention, the participants are offered a 10-week weight reduction program. those who participate in the weight-loss program are invited to an optional follow-up visit in connection with the last visit at the clinical dietician, for the purpose of exploring the effect of weight loss on the gut microbiota and obesity-associated metabolic disturbances.


Eligibility criteria:
inclusion criteria: * post-menopausal * bmi between 30-45 kg/m2 * waist circumference \> 80 cm * high leukocyte count exclusion criteria: * medically-treated type 2 diabetes or dyslipidaemia * use of antibiotics during the last 3 months * use of pro- or prebiotic supplements during the last 6 weeks * illnesses related to the gastro-intestinal tract * history of psychiatric diseases (incl. depression) * liver disease * alcohol abuse

Keywords: obesity insulin resistance microbiota probiotic prebiotic
biodentine versus white mta pulpotomy

Conditions: Extensive Decay in Primary Molars

Summary: a clinical trial to evaluate and compare three different products used for endodontic treatment (taking the infected nerve out of the teeth) of primary teeth. null hypothesis: the new biological products (wmta and biodentine) behave as good as the former iodoform product.


Eligibility criteria:
inclusion criteria: * patients (children with carious deciduous molars indicated for pulpotomy) belonging to the category of asa i according to the 'american society of anaesthesiologists'. * patients without any known medical history of systemic complications contradicting pulp treatment. * patients are indicated for treatment under general anaesthesia due to polycaries / fear / anxiety / very young age. * written consent is obtained from the parent/guardian after explaining the full details of the treatment procedure and its possible outcomes.
osteopathic health outcomes in chronic low back pain (osteopathic) trial

Conditions: Low Back Pain

Summary: the purpose of this study is to determine whether osteopathic manipulative treatment (a type of spinal manipulative therapy used by osteopathic physicians) and ultrasound physical therapy are effective in the treatment of chronic low back pain.

the purpose of this study is to determine whether osteopathic manipulative treatment (a type of spinal manipulative therapy used by osteopathic physicians) and ultrasound physical therapy are effective in the treatment of chronic low back pain. this study uses a 2x2 factorial design to test the hypotheses.

Eligibility criteria:
inclusion criteria: * must give a positive response to the question: "have you had low back pain constantly or on most days for the last three months?" * must identify the low back as the primary site of pain * must agree to not receive any of the following outside of the study during the period of participation: osteopathic manipulative treatment, chiropractic adjustment (including "mobilization" or "manipulation"), physical therapy * women must not be pregnant or plan to become pregnant during the period of study participation (a negative pregnancy test and willingness to maintain an acceptable method of contraception will be required) exclusion criteria: * history of any of the following conditions which may be underlying causes of low back symptoms: cancer, spinal osteomyelitis, spinal fracture, herniated disc, ankylosing spondylitis, cauda equina syndrome * history of surgery involving the low back within the past year or planned low back surgery in the future * history of receiving workers' compensation benefits within the past three months * involvement in current litigation relating to back problems * current pregnancy or plan to become pregnant during the course of participation in the study * any of the following that may limit a provider's choice of osteopathic manipulative treatment techniques or hamper compliance with the study protocol: angina or congestive heart failure symptoms that occur at rest or with minimal activity, history of a stroke or transient ischemic attack within the past year * any of the following that may represent potential contraindications to receiving ultrasound physical therapy: implantation of a cardiac pacemaker, implantation of artificial joints or other biomedical devices, active bleeding or infection in the low back, pregnancy * use of intravenous, intramuscular, or oral corticosteroids within the past month * history of osteopathic manipulative treatment, chiropractic adjustment, or physical therapy within the past three months or on more than three occasions during the past year * practitioner or student of any of the following: osteopathic medicine (d.o.) allopathic medicine (m.d.), chiropractic (d.c.), physical therapy

Keywords: randomized controlled trial low back pain spinal manipulative therapy spinal manipulation osteopathic manipulation osteopathic medicine physical therapy modalities
psychoneuroimmunology therapy in uncontrolled diabetic patients: a quasi-experimental study

Conditions: Diabetes Mellitus, Type 2

Summary: the psychoneuroimmunotherapy (pnit) is the study, modification and implementation of the interactions between the processes of adaptive behavior, neurological, endocrine and immune. among its premises assuming homeostasis or physiological balance as an integrated process involving the systems above mentioned. additionally, among the basics theme the re-mean is introduced, ie changing the direction, the function of a concept from a negative context carry a positive meaning, so that from the pnit no disease is seen as a problem but as a situation to solve. the patient then transmits the importance of which will come. primary objective: to investigate whether patients on pnit have a higher proportion of patients achieving disease control (\<7% in glycosylated hemoglobin (hbac1) and quality of life compared with conventional treatment patients. methodology: quasi-experimental, simple blind, simple blind, parallel, phase iii clinical trial the investigators will follow a group of patients with type 2 diabetes mellitus durgin three months with an interim analysis a month after receiving the intervention (two visits) during each visit a trained pnit physician assess the effectiveness, safety and quality of life of each patient. the investigators will include male or female patients aged 18 years-old with diabetes mellitus type ii in any severity, uncontrolled (\> 7% glycosilated haemoglobin (hbac1)) and any treatment regimen included. the patients are not allocated by a random process and the investigators will have a convenience sample the investigators will perform an intention to treat analysis, patients will be analyzed according to the intervention received even if this was different from the one they were assigned.


Eligibility criteria:
inclusion criteria: * patients who wish to participate with informed consent sign. * diagnosed with uncontrolled diabetes mellitus type ii (\> 7% of hbac1) at least six months before starting the study * no change in medication at least three months before starting the study. * participants with acceptable electrocardiographic results acceptable at the study start. exclusion criteria: * pregnant women, or planning to become pregnant during the study period. * history of severe liver failure. * participants requiring elective surgeries or other procedures requiring general anesthesia for the duration of the study. * participants who are participating in other clinical trials involving drugs or who have participated in another clinical trial in the last three months.
bone morphogenetic protein-2 in grade ii furcation defects.

Conditions: Periodontitis

Summary: the present study evaluated clinically and radiographically the regenerative potential of rhbmp-2 in absorbable sponge and prf in grade ii furcation.

44 subjects were enrolled in the study. ppd, cal, plaque index and gingival index were recorded and the evaluation of bone fill was performed after 6 months by using imagej® software. after 6 months, the bone fill obtained with rhbmp-2 was higher when compared to prf. from this trial conducted over a period of 6 months, the unique properties associated with rhbmp-2 in absorbable sponge makes it a potential agent to be used as a graft material for grade ii furcation defects.

Eligibility criteria:
inclusion criteria: * systemically healthy male and female patients of age group 20-55 yrs * grade ii furcation involvement and probing pocket depth of ≥5mm exclusion criteria: * medically compromised patients * subjects who underwent radiotherapy or chemotherapy in the past 12 months * patients having uncontrolled periodontal disease and * subjects smoking ≥10 cigarettes per day were excluded
reconstructive of multiple-digit soft-tissue defects using regional dorsal digital flaps

Conditions: Finger Injuries

Summary: reconstruction of soft-tissue defects in multiple digits poses a significant challenge. this article reports simultaneous reconstruction of multiple small-to-moderate soft-tissue defects using regional dorsal digital island flaps and evaluated the efficacy of their application in such complex situation. a retrospective study will be conducted with 26 patients who had multiple-digit soft-tissue defects treated with regional dorsal digital island flaps. at the final follow-up, we will evaluate the efficacy of their application in such complex situation.

for the recipient where sensory restoration is important, sensation of the flaps is assessed using static two-point discrimination (2pd) and semmes-weinstein monofilament (swm) testing at final follow-up. the cold intolerance of the injured finger is measured using the self-administered cold intolerance severity score questionnaire that was rated into mild, moderate, severe, and extreme (0-25, 26-50, 51-75 and 76-100). the pain of the injured finger is given subjectively by the patient using a grading system that included grade 1, none; grade 2, mild, no interference with daily activities; grade 3, moderate, patient works but has some limitation in use of the hand because of pain; and grade 4, severe, cannot work or use hand. to sum up, patients report their satisfaction with functional recovery of the injured finger according to the michigan hand outcomes questionnaire that was based on a 5-point response scale.

Eligibility criteria:
inclusion criteria: * the separate soft tissue defects with exposed bone or tendon in different digits * the soft-tissue defect≥1.5 cm and ≤3.5 cm in length * necessity to preserve digit length * local tissue near the defect can be used as the donor * a patient between 15 and 60 years of age exclusion criteria: * concomitant injuries to the dorsum of the injured finger * a defect \ 3.5 cm in length * a finger degloving injury * the defect of the thumb

Keywords: soft-tissue defects dorsal branch of the digital artery regional flap
reduction of intravenous antibiotics in neonates

Conditions: Neonatal Infection; Neonatal SEPSIS

Summary: randomized controlled open-label non-inferiority trial comparing complete intravenous antibiotic treatment with a short iv. course followed by oral antibiotics in neonates (0-28 days) with probable bacterial infection. primary outcome: - bacterial re-infection within 28 days after finishing of antibacterial therapy. secondary outcome(s): * pharmacokinetic profile of oral amoxicillin/clavulanic acid * quality of life * cost-effectiveness * alterations in gut microbiome * use of molecular techniques for better detection of bacterial pathogens

neonates have a high antibiotic consumption because of their susceptibility for bacterial infections. since the early diagnosis of bacterial infection in neonates is difficult, intravenous broad-spectrum antimicrobial therapy is usually started promptly after subtle symptoms. the majority of neonates become asymptomatic shortly after initiation; when infection is probable or proven by elevated inflammatory markers and/or a positive blood culture, intravenous antibiotics are administered for at least 7 days. however, for neonates blood culture has a limited sensitivity. therefore, the majority of neonates with probable infection are treated for a prolonged time with intravenous broad-spectrum antimicrobial therapy. in older children, intravenous antibiotics are often changed to oral antibiotics after cessation of symptoms and decreasing inflammatory parameters. this is not yet widely practised in neonates because of uncertainties in pharmacokinetics. two explorative small studies from france and italy into neonatal antibiotic switch therapy suggest that follow-up treatment with an oral antibiotic is promising; but the non-inferiority and safety was not yet properly addressed. neonatal switch therapy, if proven to be safe and efficacious, would have a major impact on neonatal well-being, mother-to-child bonding and moreover costs.

Eligibility criteria:
inclusion criteria: * neonates (≥ 35+0 weeks, 0-28 days old, ≥ 2 kg) * probable bacterial infection defined as clinical symptoms and/or maternal risk factors and elevated inflammatory markers for which empiric broad-spectrum antibiotic treatment was initiated and needs to be continued for \> 48 hours * clinically well * toleration of oral feeding without overt vomiting * signed informed consent exclusion criteria: * proven bloodstream infection * absence of blood culture * severe localized infection (meningitis, osteomyelitis, necrotizing enterocolitis) * severe clinical sepsis (compromised circulation, need for mechanical ventilation) * continuous need for a central venous line * severe hyperbilirubinemia exceeding the exchange level * parents inability to administer medication * major congenital or syndromic anomalies

Keywords: antibiotic switch therapy amoxicillin/clavulanic acid
automated parkinson's disease (pd) motor symptom assessment for deep brain stimulation (dbs) programming

Conditions: Parkinson's Disease

Summary: the purpose of this study is to evaluate the utility of a portable motion sensor-based system designed to assist with deep brain stimulation (dbs) programming sessions for parkinson's disease patients.


Eligibility criteria:
inclusion criteria: * hoehn and yahr stage 2 or worse when off medications * average tremor and/or bradykinesia unified disease rating scale (updrs) score greater than 2 off meds * l-dopa responsive with clearly defined "on" periods, updrs motor iii average tremor and bradykinesia improves by 25% * stable on medical therapy for at least one month prior to study enrollment * clinical approval to undergo unilateral dbs surgery targeting the stn or gpi * available to participate for six months following dbs surgery exclusion criteria: * "parkinson's plus" syndromes, secondary, or atypical parkinson's syndromes (e.g. progressive supranuclear palsy, striato-nigral degeneration, multiple system atrophy, post-stroke, post-traumatic, or post-encephalitic parkinson's. these patients have cardinal symptoms characteristic of pd but with additional symptoms indicating other organic brain dysfunction, such as gaze palsies, autonomic dysfunction, lack of response to l-dopa, these individuals tend not to improve with standard treatments for pd) * previous parkinson's disease surgery * medical contraindications to surgery or stimulation (e.g. uncontrolled hypertension, advanced coronary artery disease, other implanted stimulation or electronically-controlled devices including cardiac demand pacemaker, aneurysm clips, cochlear implants, or a spinal cord stimulator) (note: for the subject who receives either a pacemaker and/or defibrillator after this study enrollment, he/she will be allowed to continue the study if the neurostimulator system can be adequately programmed to permit system compatibility) * contraindication to magnetic resonance imaging (e.g. indwelling metal fragments or implants that might be affected by mri) * neuropsychological dysfunction (e.g. dementia) that would contraindicate surgery * intracranial abnormalities that would contraindicate surgery (e.g. stroke, tumor, vascular abnormality affecting the target area)

Keywords: deep brain stimulation monopolar review motion sensors tremor bradykinesia
dexamethasone for espb in pain management after pediatric idiopathic scoliosis surgery

Conditions: Scoliosis; Scoliosis Idiopathic; Scoliosis; Adolescence

Summary: effect of perineurial dexamethasone on erector spinal plane block duration for pediatric, idiopathic scoliosis surgery.

this study proposes to explore the effect of perineurial dexamethasone on erector spinal plane block duration for pediatric idiopathic scoliosis surgery. children need good analgesia after scoliosis surgery. peripheral nerve blocks have provided a safe, effective method to control early postoperative pain when symptoms are most severe. the safety of local anesthesia is essential in children due to the much lower toxicity threshold of local anesthetics. an effective adjuvant, such as dexamethasone, could allow for a higher dilution of local anesthetics while maintaining and enhancing their analgesic effect.

Eligibility criteria:
inclusion criteria: * children scheduled for idiopathic scoliosis surgery * age \>10 and \<18 years exclusion criteria: * age \< 10 years * age \< 18 years * infection at the site of the regional blockade * coagulation disorders * immunodeficiency * asa= or \>4 * steroid medication in regular use
music prior to a t380a intrauterine device insertion in nulliparous women.

Conditions: Intrauterine Device

Summary: the aim is to evaluate the role of music in reducing pain and anxiety during copper iud insertion in nulliparous women

the aim is to evaluate the role of music in reducing pain and anxiety during copper iud insertion in nulliparous women

Eligibility criteria:
inclusion criteria: * nulliparous women aged over 18 years of age requesting a copper iud for contraception who had a negative pregnancy test. exclusion criteria: * a prior pregnancy greater than 20 weeks of duration * currently pregnant or were pregnant within 6 weeks of study entry * had a prior attempted or successful iud insertion * had a history of a cervical procedure such as cone biopsy, loop electrosurgical excision procedure, or cryotherapy any world health organization medical eligibility criteria category 3 or 4 precaution to an iud active vaginitis or cervicitis * undiagnosed abnormal uterine bleeding * pelvic inﬂammatory disease within the last 3 months * ﬁbroids or other uterine abnormalities distorting the uterine cavity
increased extravascular lung water in asymptomatic open-water swimmers

Conditions: Pulmonary Edema - Acute; Extravascular Lung Water

Summary: previous studies suggest that increased extravascular lung water might be found in open water swimmers without respiratory symptoms. this study aims to investigate a large number of asymptomatic individuals after an open-water swimming race to assess the prevalence of increased extravascular lung water in asymptomatic open-water swimmers.

swimming-induced pulmonary edema (sipe) can occur during open-water swimming. the pathophysiological mechanisms are still partly unknown, but central pooling of blood volume and peripheral vasoconstriction have been suggested as important factors. sipe is characterized by acute onset of dyspnea and cough, sometimes with excessive sputum and hemoptysis. the condition usually resolves spontaneously, but medical attention can be required in more severe cases. previous studies suggest that sipe is diagnosed by clinical symptoms, decreased peripheral oxygen saturation and signs of pulmonary edema on lung ultrasound. interestingly, signs of increased extravascular lung water have been found in divers without respiratory symptoms. there are no similar studies regarding open-water swimmers. this study aims to investigate a large number of swimmers without respiratory symptoms after finishing an open-water swimming race. prevalence and amount of increased extravascular lung water after swimming will be assessed by lung ultrasound. in addition, individual baseline factors and information about the race associated with increased extravascular lung water will be evaluated. this study will provide better understanding of the pathophysiological mechanism of sipe.

Eligibility criteria:
inclusion criteria: * completion of an open-water swimming race during the "vansbrosimningen" open-water swimming event * no respiratory symptoms (dyspnea and/or cough) during or right after the race * age ≥ 18 years exclusion criteria: * presence of respiratory symptoms (dyspnea and/or cough) during or right after the swimming race * declines participation

Keywords: pulmonary edema asymptomatic pulmonary edema swimming induced pulmonary edema sipe pulmonary edema in swimmers extravascular lung water
cell biology of steroid resistant asthma

Conditions: Asthma

Summary: the hypothesis is that patients who demonstrate steroid resistant asthma by showing little or no improvement in lung function after a course of oral steroids have different cellular responses to steroids than patients who are steroid sensitive. these altered responses are the reason they demonstrate steroid resistance.

current nhlbi guidelines for persistent asthma management recommends the use of steroids for treatment of airway inflammation (1,2). however, some asthmatics do not respond to steroids (3-6). unfortunately these patients are subjected to the unwanted side effects (osteoporosis, cataracts, etc) of high dose steroid therapy because non-immune tissues remain sensitive to steroids. recent studies suggest that the costs of asthma are largely attributable to uncontrolled disease (7). thus, it is important to understand the mechanism(s) of steroid resistance and introduce new forms of therapy for the treatment of these difficult to control asthmatics. as a prelude to pharmaceutical studies in steroid resistant asthma, it is imperative to develop biomarkers that can robustly identify individuals likely to be poor steroid responders so that alternative non-steroid anti-inflammatory therapies, such as xolair®, can be introduced early in the course of asthma therapy.

Eligibility criteria:
inclusion criteria: 1. will meet american thoracic society criteria for asthma 2. pulmonary function tests consistent with asthma. this includes a baseline fev1 \< 80% predicted as well as a 12% improvement in fev1 following up to 4 puffs of albuterol. 3. subjects must be 12 to 65 years old. exclusion criteria: 1. viral infection within four weeks of the starting date. 2. abnormal hepatic function. 3. history of copd 4. pregnancy. 5. history of smoking. 6. anemia (hemoglobin less than 12 gm %) 7. concurrent therapy with anticonvulsants, erythromycin, rifampin and any systemic asthma medication including singular®, xolair® or oral prednisone. 8. greater than 500 mcg per day of inhaled corticosteroids 9. suspected non-compliance with medical care. 10. abnormal prednisone pharmacokinetics (applies to phase 2 of trial) 11. patients with severe medical conditions that in the view of the investigator prohibits participation in the study (specify as required) 12. use of any investigational agent in the last 30 days

Keywords: steroid resistant asthma