Kornimate/medical-research-clean huggingface dataset:
comparison of patient-reported pain after initial archwire placement

Conditions: Orthodontic Discomfort; Pain, Orofacial

Summary: three different types of 'archwires' can be used in orthodontic treatment, wire choice is decided by treating orthodontist based on professional preference since research shows that all types are equally effective. it is possible that one type of wire engenders more patient discomfort. this study will compare the discomfort levels engendered by the three wire types to determine if there is one that induces the least amount.

orthodontic treatment with fixed appliances has the potential to induce pain in patients. at the beginning of treatment, the orthodontist must determine which initial orthodontic archwire to insert. among the more popular choices for initial leveling and aligning of the dental arches are small-sized, round-diameter nickel-titanium archwires. various types of nickel-titanium (niti) archwires exist including stabilized martensitic wires (ie classic nitinol), active austenitic wires (superelastic niti) and active martensitic wires (thermoelastic niti). the efficacy of these wire types has been heavily researched with no significant differences in the alignment timing of the dentition (treatment time to reach the final archwire). pain differences from these wires has been inconclusive from conflicting past studies. it is of critical importance to determine whether one or more of these archwires leads to more discomfort for the patient than the others.

Eligibility criteria:
inclusion criteria: 1. healthy, with no significant systemic diseases or complications or special needs 2. requiring a minimum of 1 dental arch (first molar to first molar) labial fixed orthodontic appliance banded/bonded in 1 appointment 3. all banded/bonded teeth can be ligated to initial archwire (no severely displaced or blocked out teeth). 4. any planned dental extractions that is part of the orthodontic treatment plan must be carried out at least 3 weeks prior to or after initial orthodontic appliance bonding. 5. age 12 years or older exclusion criteria: 1. currently taking or recently taken sulfonamides, monoamine oxidase inhibitors, tricyclic antidepressants, or phenothiazines 2. currently taking physician-prescribed medical marijuana for the management of pain or recreational marijuana during the trial period 3. metal-type (nickel) allergies 4. less than 12 years old 5. same day use of analgesics prior to bonding 6. treatment requiring dental extractions prior to or immediately after bonding of fixed appliance

Keywords: orthodontic pain
trial of probiotics for constipation in parkinson's disease

Conditions: Parkinson Disease

Summary: this is a double blinded randomised placebo controlled trial to evaluate the efficacy of probiotics in the treatment of constipation in parkinson's disease.


Eligibility criteria:
inclusion criteria: * age 50 to 80 years old * provision of written informed consent * diagnosis of pd made by a neurologist using uk brain bank criteria * fulfils criteria for functional constipation according to the rome iv criteria during in the preceding 6 months with frequency of bowel movements less than 3 times per week exclusion criteria: * ingestion of probiotics in the preceding 4 weeks * use of antibiotics in the preceding 4 weeks * history of gastrointestinal disorders or surgery * known or suspected allergy to probiotics * comorbidities that prevent reliable completion of study assessments * prior functional neurosurgery for pd or treatment with apomorphine infusion * recent initiation of dopaminergic medications in the preceding 3 months
adjuvant psychotherapy for relapse prevention in early adulthood (< 35 yr.) of bipolar disorder

Conditions: Bipolar Disorder

Summary: this efficacy study compares an adjuvant specific psychotherapy and an active control intervention for bipolar disorder under mood stabilizer to prevent relapse an maintain remission. patients should be in their early (18-30 yr.) phase of illness without having suffered of to many affective episodes (below 6), already. in addition, psychological, social, and neurobiological mediators and moderators well be identified.

there is still a lack of controlled outcome and follow-up studies about the role of adjuvant psychotherapy in bipolar disorder. by treating older subjects having suffered of multiple affective episodes, the potential benefit of psychotherapy to prevent relapse and help to adjust to this chronic illness might be underestimated. in addition, the investigators have no knowledge of mechanism (mediators) of positive changes by successful psychotherapy and of subjects with good outcome of adjuvant psychotherapy (moderators, indicators, predictors). possible mediators and moderators can be sociodemographic, psychological (cognitive, interactional), and/or biological (neuronal, genetic). the planned study will address all three areas of questions. in a multi-center study, 300 younger subjects suffering of a bipolar disorder will be included and provide with one of two treatments in addition to stable medication. moderators and mediators are selected on promising preliminary results and based on a psycho-biological understanding of bipolar disorder.

Eligibility criteria:
inclusion criteria: * bipolar i and bipolar ii disorder, * 18 to 55 years of age, * giving informed consent to assessment, treatment, and randomization, * currently remitted (for at least 4 weeks) and taking medication, * less than 6 previous affective episodes exclusion criteria: * currently symptomatic (depressed, manic, hypomanic), * suicidal, * not taking medication, * schizo-affective, schizophrenic, borderline personality disorder, * not giving or withdrawing consent

Keywords: bipolar i disorder bipolar ii disorder relapse prevention
efficacy of the aussie current in patients with knee osteoarthritis.

Conditions: Osteoarthritis, Knee; Quadriceps Muscle Atrophy

Summary: introduction: osteoarthritis (oa) of the knee is a musculoskeletal disorder and is associated with significant implications related to public health and socioeconomic factors resulting in leave from work. currently, there are several types of conservative treatment for this pathology, such as medications and mainly muscle strengthening, recommended by international guidelines. it can be associated with neuromuscular electrostimulation (nmes) as with the aussie current, for example, which aims to increase strength and function earlier. objective: to determine whether the effectiveness of adding nmes to the aussie current in patients with knee oa who receive treatment based on the principles of conventional physiotherapy, in relation to pain relief, improvement of functional disability and muscle strength. materials and method: forty individuals will be randomly distributed in two groups, with group 1 (g1) exercises and placebo application of electrostimulation and group 2 (g2) exercises and application of nmes with the aussie current in the quadriceps femoris muscle. in the treatment, 24 sessions will be carried out in a period of 12 weeks based on the gold standard for the treatment of knee oa. clinical outcomes of pain intensity, functional disability and muscle strength will be measured at baseline, immediately after 12-week treatment and after 24-week follow-up by a single blinded evaluator at all stages. all statistical procedures will be carried out following the principles of "intention to treat" and the comparison between groups will be carried out through the test of mixed linear models. expected results: it is expected that there will be improvement in the variables: pain, functional capacity and strength in both the groups, however in the group that carried out the application of the aussie current, the gains would be more precocious, when compared to the group that did not carry out the nmes.


Eligibility criteria:
inclusion criteria: * medical diagnosis of oa in the knees, * pain for another 06 months * both genders * age between 45 and 80 years * grade i to iii, according to kellgren-lawrence. exclusion criteria: * bearers of severe spine, hip and ankle diseases (fractures and tumors and inflammatory pathologies) * neurological impairment * severe cardiorespiratory diseases
comparison of laparoscopic totally extraperitoneal (tep) and lichtenstein technique

Conditions: Hernia, Inguinal

Summary: open tension-free mesh repair (lichtenstein) and laparoscopic totally extraperitoneal (tep) repair are the most commonly preferred techniques for inguinal hernia surgery. there's still a debate going on about which of these two techniques (open versus laparoscopic) is effective. this prospective randomized study aimed at comparing the early and long-term results of these two techniques (tep vs. lichtenstein).

various studies comparing the laparoscopic totally extraperitoneal (tep) and lichtenstein techniques have been reported. these studies have shown that tep repair is associated with less postoperative pain and faster recovery. however, there are different views on the long-term (recurrence, chronic pain, etc.) results of the two techniques. this study was designed to compare the short- and long-term outcomes of open tension-free mesh repair technique(lichtenstein) and laparoscopic repair technique(tep).

Eligibility criteria:
inclusion criteria: * patients who were diagnosed with inguinal hernia (primary, recurrent, unilateral, bilateral) * american society of anesthesiologists (asa) score of i and ii * gave informed consent to participate in the study exclusion criteria: * patients with scrotal, strangulated, or obstructed hernia * periumbilical or subumbilical incision scar (median, right or left paramedian) * undergoing prostatectomy or abdominal bladder surgery * pfannenstiel incision scar * asa score \>3

Keywords: hernia laparoscopic lichtenstein
molecular genetic studies of childhood brain tumors and blood samples

Conditions: Brain Cancer

Summary: to look for patterns of polymorphisms in dna repair in both germline and tumor cells samples.


Eligibility criteria:
inclusion criteria:pediatric cancer patients diagnosed with brain tumors
study to assess the effect of gabapentin, diphenhydramine and morphine on cold pain in healthy male volunteers

Conditions: Healthy

Summary: human experimental pain models are useful in understanding the mechanisms underlying clinical pain conditions and can be used to test the analgesic efficacy of drugs used in the management of pain. once established these models can be used as mechanism biomarkers in early development clinical studies to establish proof of mechanism for novel compounds. the cold pain model is a mechanistic pain biomarker with potential application in proof of mechanism studies. in this study we aim to set up this cold pain model at a clinical research unit and demonstrate we can effectively screen subjects for this model and examine the effect of morphine, diphenhydramine, and gabapentin in the cold pain model.

cold pain methodology development

Eligibility criteria:
inclusion criteria: * healthy male volunteers having given consent to participate in the study who have no clinically significant anomalies and whose vital signs are within normal range. * subject having performed the cold pain test reproducibly ie, if the area under the pain-time curve (auc) must be within 20% during successive tests within one cold pain test screening visit and within 30% between the two cold pain test screening visits. exclusion criteria: * subject who have had a serious adverse reaction or significant hypersensitivity to any of the study drugs. * subjects with a history of or evidence of any neurological condition which could affect pain sensation. * subjects with an auccpt 0-120 sec in the cold pain test of \<1000 in any of the screening tests (excluding familiarization).

Keywords: cold pain methodology healthy male volunteers gabapentin diphenhydramine morphine
comparison of the safety and pharmacokinetics of two sar153191 (regn88) drug products in rheumatoid arthritis patients

Conditions: Rheumatoid Arthritis

Summary: primary objective: assess the comparative safety and tolerability of two sar153191 (regn88) drug products after a single dose administration in rheumatoid arthritis patients. secondary objective: assess the comparative pharmacokinetic profiles of the two sar153191 (regn88) drug products after a single dose administration in rheumatoid arthritis patients.

the duration of the study period per subject is 5-7 weeks broken down as follows: * screening: 1 to 14 days, * treatment: 1 day (2 overnight stays at the study site), * follow-up: up to 5 weeks after dosing (an additional outpatient follow-up may be scheduled depending on the last results).

Eligibility criteria:
inclusion criteria: * diagnosis of rheumatoid arthritis (ra) \> or = 3 months duration. * treated for a minimum of 12 weeks with methotrexate (mtx) prior to randomization. treatment must be continued on a stable dose for the duration of the study. exclusion criteria: * autoimmune disease other than ra. * history of acute inflammatory joint disease other than ra. * surgery within 4 weeks prior to the screening visit or with planned elective surgery within the next 3 months. * latent or active tuberculosis. * fever (≥38 c) or persistent chronic or active recurring infection requiring treatment with antibiotics, antivirals, or antifungals within 4 weeks prior to the screening visit, or history of frequent recurrent infections. * received administration of any live (attenuated) vaccine within 3 months prior to the randomization visit (eg, varicella-zoster vaccine, oral polio, rabies). * received tuberculosis vaccination within 12 months prior to screening * prior therapy with a tumor necrosis factor (tnf) antagonist or any other biologic agents within 3 months prior to inclusion. * known latex sensitivity. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
influence of hormone therapy on heart attack incidence in men undergoing prostate brachytherapy

Conditions: Prostate Cancer; Cardiovascular Death

Summary: the purpose of this study is to review cause of death in patients undergoing prostate brachytherapy at a single institution. furthermore, we are analyzing patients undergoing androgen deprivation therapy and whether or not this contributed to cardiovascular deaths, specifically myocardial infarction.


Eligibility criteria:
inclusion criteria: * deceased anytime after prostate brachytherapy treatment exclusion criteria: * patients whose cause of death was unable to be determined
pharmacodynamics modeling to optimize dosage regimens of sulbactam in patients with acinetobacter infections

Conditions: Acinetobacter Infections

Summary: acinetobacter species have emerged as agents of serious nosocomial infections in critically ill patients. only a few effective antibiotics are currently available for the treatment of this pathogen and, therefore, sulbactam is being considered as an alternative treatment option. the aims of this study were to i) reveal the population pharmacokinetics and ii) assess the probability of target attainment (pta) of sulbactam in septic critically ill patients caused by acinetobacter spp. infections. the study was conducted in septic critically ill patients caused by acinetobacter spp. each patient received 2 g every 12 h of sulbactam for 10 days, after which pk studies were carried out on day 4 of sulbactam therapy and a monte carlo simulation was performed to determine the probability of attaining a specific pharmacodynamic target.


Eligibility criteria:
inclusion criteria: * patient aged ≥ 18 years * patients who had diagnosed an acinetobacter infections that sensitive to sulbactam and colistin * infected at sterile site * pneumonia was defined by a new and persistent infiltrate on chest radiography associated with at least one of the following: purulent sputum, temperature\>38.3°c or \ 10,000 cell per mm3, heart rate of \>90 beats per min and respiratory rate \>20 breaths per min * urinary tract infection: acinetobacter spp ≥ 100,000 cfu/mm3 exclusion criteria: * patients who are pregnant. * patients who have documented hypersensitivity to sulbactam and colistin * patients who are chronic renal disease * patients who are shock

Keywords: sulbactam pharmacokinetics pharmacodynamics acinetobacter infections
validation of the back beliefs questionnaire to the turkish

Conditions: Low Back Pain

Summary: the back beliefs questionnaire (bbq) developed by symonds et al. in 1996 is used to measure patient's attitudes and beliefs towards recovery and return-to-work; and expectations regarding the negative circumstances that could be created as a result of low back pain (lbp).the aim of this study was the translation to turkish language, cross-cultural adaptation and assessment of reliability\&validity of bbq for the patients suffering from chronic lbp.

back beliefs questionnaire was translated and culturally adapted into turkish regarding to the published guidelines. this observational cross-sectional study was performed with 110 chronic low back pain patients. all participants were asked to complete back beliefs questionnaire and also fill the socio-demographic data form and evaluation tools (numeric rating scale-pain, oswestry disability index, fear avoidance beliefs questionnaire, hospital anxiety and depression scale). internal consistency was evaluated with cronbach's alfa coefficient. intraclass correlation coefficient was used to assess test-retest reliability. structural validity was assessed by correlations with other tools. back beliefs questionnaire had a good internal consistency (cronbach alfa= 0.79) and an excellent test-retest reliability (intraclass correlation coefficient = 0.84). a moderate correlation was determined between back beliefs questionnaire and fear avoidance beliefs questionnaire. correlations with numeric rating scale-pain, oswestry disability index, hospital anxiety and depression scale were fair. turkish version of back beliefs questionnaire is a valid and reliable questionnaire that can be used to evaluate beliefs about pain in patients with chronic low back pain.

Eligibility criteria:
inclusion criteria: * turkish speaking * suffering from low back pain during activity for over 3 months exclusion criteria: * pregnancy * malignancy * infections * fractures * inflammatory diseases * cognitive impairments that might create a problem in comprehending and filling the survey

Keywords: low back pain turkish language pain beliefs validity
study evaluating the safety and efficacy of etanercept in patients with psoriatic arthritis treated by rheumatologists

Conditions: Arthritis, Psoriatic; Psoriasis; Skin Diseases, Papulosquamous

Summary: the purpose of this study is to evaluate the safety and effectiveness of etanercept under usual care settings in patients with psa treated by rheumatologists.

non-interventional study: subjects to be selected according to the usual clinical practice of their physician

Eligibility criteria:
inclusion criteria: * clinical diagnosis of psoriatic arthritis exclusion criteria: * sepsis or risk for sepsis, * acute infection, * hypersensitivity against etanercept

Keywords: arthritis
microbiome vaginae after use of oral probiotics in pregnancy.

Conditions: Pregnancy; Infection Genitourinary System

Summary: change of vaginal microbiome in first trimester pregnant women after oral intake of probiotic preparation with 4 lactobacilli strains

although the research of the vaginal microbiome is taking faster pace in recent years than it was the case before, there is still lack of information, about its composition, how and when it changes and how that can affect processes in the female body. during pregnancy, the microbiome physiologically gets increasingly stable. diversity of bacteria decreases, which is the sign of a healthy microbiome, and lactobacillus species increase their already pre-existing dominance. acidic metabolites of those bacteria maintain the low ph and low diversity in vagina. if the dominance of lactobacilli is not as large as it should be, the risk of preterm birth increases significantly. low relative abundance of lactobacillus species, especially lactobacillus crispatus (marker of the healthy microbiome) and lactobacillus metabolites as well as high vaginal microbial diversity are most significantly connected with preterm birth. despite such a high relevance of vaginal microbiome for a healthy pregnancy, and for women's health in general, there's an insufficient proof that the intake of oral probiotics can change it. the aim of our study is to see if the intake of patented dietary supplement, containing four lactobacillus strains can change the relative abundance of different bacteria in the vaginal microbiome. this could lay ground for further research in this area and even create new therapeutic approaches in the future.

Eligibility criteria:
inclusion criteria: * pregnant women aged between 18 and 45 * infection screening during a prenatal consultation between 10+0 (10 weeks plus 0 days) and 16+0 (16 weeks plus 0 days) gestational weeks * singleton pregnancy exclusion criteria: * vaginal infections such as bacterial vaginosis, candida vaginitis, trichomoniasis, mycoplasma, gonococcal infection * antibiotic therapy in the last 4 weeks * probiotic therapy in the last 4 weeks * operation on gastrointestinal tract * diarrhoea, obstipation * vaginal bleeding * patients with hormone disorders of any kind * other chronic diseases (diabetes, autoimmune diseases etc.) * hiv * gestational diabetes

Keywords: probiotics pregnant women microbiome
combination of docetaxel + estramustine + hydrocortisone versus docetaxel + prednisone in patients with advanced prostate cancer

Conditions: Prostatic Neoplasms

Summary: to compare the efficacy of both strategies (reference treatment: docetaxel+prednisone and experimental treatment: docetaxel+estramustine+hydrocortisone) by means of psa values. to determine the time to treatment failure in both strategies to determine the overall and specific cause survival to evaluate the safety profile to analyze the quality of life


Eligibility criteria:
inclusion criteria: * histological or cytological confirmation of prostate adenocarcinoma * advanced prostate carcinoma. * previous treatment with hormones * levels of testosterone \< 50 ng/dl * good hematological, liver and kidney function * previous treatment with surgery or radiotherapy, at least 4 weeks since end of treatment is allowed (the patient should have been recovered from any side effects. exclusion criteria: * previous chemotherapy (estramustine included). * second line hormonotherapy (oestrogens, gestagens, ketoconazole, ...included) * previous treatment with radiotherapy (isotopes) or previous radiotherapy over \> 25% of the marrow * any malignant process with a free disease interval under 5 years, exception done to non-melanoma skin cancer. * concomitant serious diseases * concomitant treatment with any other neoplassic therapy (exception done to lhrh agonists and/or biphosphonates). * contraindication for the treatment with estramustine. * previous history of pulmonary embolism, thromboembolic disease, previous treatment with anticoagulants (except aspirin), active thrombophlebitis or hypercoagulation. * previous history of pulmonary spillage or ascitis. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.