Kornimate/medical-research-clean huggingface dataset:
long-term real-world outcomes study on patients implanted with a neurostimulator

Conditions: Chronic Pain

Summary: the reality study is a prospective, post-market, non-randomized, multi-center, single-arm, open-label study intended to collect short- and long-term safety and effectiveness data on various populations implanted with abbott's neurostimulation systems.

this study has broad inclusion criteria and minimal exclusion criteria to ensure the results are representative of the real-world use of these devices. enrollment caps will be implemented to ensure patients from approved indications are represented. individuals who are scheduled to receive an implantable abbott neurostimulation system are eligible for study consideration. the study will enroll up to 2,000 subjects from up to 100 participating centers. subject enrollment is expected to be completed within 7 years; subjects will be followed for 5 years. the total duration of the study is expected to be 13 years, including enrollment, data collection from all subjects, and study close out.

Eligibility criteria:
inclusion criteria: 1. subject must provide written informed consent prior to any clinical investigation related procedure. 2. subject is at least 18 years (or the minimum age required by local law to consent for participation in a clinical investigation) or older at the time of enrollment. 3. subject is scheduled to have an abbott neurostimulation system implanted within 60 days of baseline. 4. subject has a baseline (with no stimulation) pain nrs of ≥ 6. exclusion criteria: 1. subject is enrolled, or intends to participate, in a competing clinical study, as determined by abbott. 2. presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements. 3. subject has or is scheduled to receive an intrathecal pump. 4. subject is part of a vulnerable population. 5. subject has an existing implanted neuromodulation device to address their chronic pain.

Keywords: spinal cord stimulation dorsal root ganglion stimulation
the study of gw493838, an adenosine a1 agonist, in peripheral neuropathic pain

Conditions: Neuropathic Pain

Summary: the purpose of this study was to determine the analgesic effect of gw493838 in patients with post-herpetic neuralgia or peripheral nerve injury caused by trauma or surgery.


Eligibility criteria:
inclusion criteria (subjects must meet all of the following criteria in order to be eligible for this study): * females of non-child-bearing potential * diagnosis of peripheral neuropathic pain as a result of: postherpetic neuralgia (phn) from shingles for at least 3 months duration or focal neuropathic pain related to nerve injury caused by trauma or surgery * defined area of pain exclusion criteria * discontinue agents for the treatment of neuropathic pain * unable to refrain from alcohol and sedative use during the study * confounding chronic pain which could not be differentiated from the peripheral neuropathic pain under study * intractable pain of unknown origin or active infection in the area of nerve injury. * clinically significant medical history or abnormality found on physical examination, laboratory assessment or ecg at screening or baseline * severe asthma that has required oral corticosteroid use in the last 12 months or the subject had severe asthma that required, at anytime, hospitalization or mechanical ventilation support. * clinical evidence of major depression (by medical history) except those subjects controlled by ssris. * a known allergy or hypersensitivity to any of the investigational products (including rescue analgesia- acetaminophen), or pharmacological class of the investigational product (i.e. adenosine) and/or investigational product excipients. * a clinically significant abuse of substances, defined as: patterns of substance intake consistent with disruption of normal function in society; past or current impairment of organ function reasonably related to substance intake; any indication of difficulty in abstaining from substances for the duration of the study. * had previously participated in a clinical study during the past 30 days in which the subject was exposed to an investigational or non-investigational drug or device * currently participating in another clinical study in which the subject was exposed to an investigational or non-investigational drug or device * prior blood reduction (450 ml or more) during the previous 30 days * at risk of non-compliance * a woman of childbearing potential or a woman who was lactating.

Keywords: neuropathic pain
high-frequency vs. low-frequency vs. sham dmpfc-rtms for major depression

Conditions: Depression

Summary: this trial will compare the efficacy and tolerability of 20 hz vs. 1 hz vs. sham repetitive transcranial magnetic stimulation targeting the dorsomedial prefrontal cortex, delivered twice daily over 15 days, in patients with a diagnosis of major depressive disorder. the trial will include structural and functional mri, eeg, and behavioral measures obtained before, during, and after treatment.


Eligibility criteria:
inclusion criteria (patient): * voluntary and competent to consent to treatment * mini confirmed diagnosis of mdd * outpatient * between the ages of 18-65 * failed to achieve a clinical response to at least one pharmacotherapy or behavioral treatment in the current episode. * have had no increase or initiation of any psychotropic medication in the last 4 weeks prior to screening * must adhere to study assessment and intervention schedule. * pass the tms safety screening questionnaire. exclusion criteria (patient): * have a concomitant major unstable medical illness, cardiac pacemaker or implanted medical pump * have active suicidal intent * are pregnant * have a lifetime mini diagnosis of bipolar i or ii disorder, schizophrenia, schizoaffective disorder, schizophreniform, delusional disorder, or current psychotic symptoms have a mini diagnosis of obsessive-compulsive disorder, post-traumatic stress disorder (current or within the last year), anxiety disorder (generalized anxiety disorder, social anxiety disorder, panic disorder), or dysthymia assessed by a study investigator to be primary and causing greater impairment than mdd * have received rtms for any previous indication due to the potential compromise of subject blinding.

Keywords: brain stimulation rtms
heparin 100u/l for prevention of pvc complications

Conditions: Peripheral Venous Catheter Complications; Occlusion; Phlebitis; Ecchymosis

Summary: flushes with saline solution are used for maintaining patency of peripheral intermittent intravenous catheters in many institution based on the results of previous studies showing that 10 u heparin/ml is not better than saline in this respect. the latest meta-analysis investigated also safety and efficacy of heparin concentrations of 100 u/ml used as an intermittent flush, but no firm conclusion was reached because of limitations of the few available studies.


Eligibility criteria:
inclusion criteria: * requiring i.v. therapy for an expected duration longer than five days * admitted to the 3rd medical ward of irccs policlinico san matteo exclusion criteria: * bleeding tendency * platelet count less than 100 x 109/l * coagulation defects * previous adverse reaction to heparin * programmed cytotoxic therapy * inability to give an informed consent

Keywords: peripheral venous catheter complications pvc occlusion pvc phlebitis
regenerative treatment of traumatized immature permanent incisors with pulp necrosis

Conditions: Regenerative Endodontics in Traumatized Immature Teeth

Summary: endodontic management of traumatized immature permanent teeth with pulp necrosis is both a clinical challenge for the dental practitioners and a public health care problem. even though there are feasible treatment procedures (such as apexification with calcium hydroxide and with mineral trioxide aggregate (mta), the long-term survival of these teeth is questionable because none of these techniques can provide continuation of root formation and thickening of the dentin walls. as a result, the immature tooth is weak and prone to fracture. recently, regenerative endodontic procedures have gained much attention as biologically based treatment alternative to the techniques described above, but the scientific evidence is insufficient. these procedures aim to remove necrotic and damaged tissues and replace those with healthy functioning pulp-dentin complex. we plan to invite 120 patients to participate in this study. the inclusion criteria will be children between the ages of 7-19 years with traumatized permanent incisors with immature roots and open apices and pulp necrosis. patients will be recruited from specialist clinics in stockholm, västerbotten and norrbotten. the patients will be treated by specialists in endodontics and pediatric dentistry with regenerative endodontics. during a 5-year follow-up period the most important outcomes are continuous root development and healing of pulp necrosis. severe traumatic dental injuries leading to severe complication that could result in early tooth loss can have a severe impact on oral health related quality of life. therefore, regenerative endodontics can have beneficial effect treating these teeth.


Eligibility criteria:
inclusion criteria: * traumatized permanent incisors with immature roots and open apices * pulp necrosis and apical periodontitis (if present) * no history of received endodontic treatment of the particular tooth * pulp space not needed for post or core restoration * good compliance of patient and parents * ages from 7-19 years and both genders exclusion criteria: * traumatized permanent incisors with mature roots with closed apices (\< 1 mm) * retreatment cases * marginal periodontitis * root fracture * intraoperative factors such as: lack of bleeding from the periapical tissue, exudate in the root canal prior to revascularization * allergy to medicaments used for the treatment

Keywords: dental trauma pulp necrosis regenerative endodontics
role of hba1c in predicting adverse pregnancy outcomes

Conditions: Gestational Diabetes

Summary: this study aims to determine the reference value of hba1c that can be used to predict adverse pregnancy outcomes. these adverse outcomes include lga fetus, shoulder dystocia, caesarean section, pre-term birth, pre-eclampsia and fetal neonatal hypoglycaemia.

this study involves the data in our centre concerning women with gestational diabetes mellitus. the diagnosis of gestational diabetes mellitus is based on nice guideline whereby the fasting glucose is 5.6 mol/l or more and 2 hours post glucose load 7.8 mol/l or more. the results of hba1c and fructosamine taken during the antenatal care are documented. outcomes of the pregnancy are documented such as antenatal complications, mode of delivery, gestational age at delivery, intrapartum and postpartum complications and neonatal complications. the results of this study is hoped to provide information on the optimum targeted levels of hba1c and fructosamine for patients with gestational diabetes mellitus. this is the gap in knowledge in managing this cohort of patients.

Eligibility criteria:
inclusion criteria: * pregnant woman with singleton pregnancy * confirmed diagnosis of gdm based on malaysia cpg (≥5.1/7.8) * hba1c level taken at least once at any time during the pregnancy * delivery after 28 weeks gestation exclusion criteria: * major fetal anomaly * haemoglobin level of ≤9 g/dl (moderate or severe anaemia in pregnancy) * women with autoimmune diseases * overt diabetes or pre-existing diabetes

Keywords: hba1c gestational diabetes large for gestational age shoulder dystocia caesarean section
activity and safety of oral administration of ssr150106xb for the reduction of inflammation in patients with active rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: the primary objective of this study is to assess the reduction of systemic inflammation as measured by serum levels of c-reactive protein (crp). the secondary objectives are: * to assess the reduction of systemic inflammation as measured changes in acute phase protein, serum amyloid a (saa) and cytokine interleukin-6 (il-6), and clinical american college of rheumatology response rate, and morning stiffness duration; * to assess the effect on pain relief within first 14 days; * to obtain evidence of the safety and tolerability of ssr150106; * to document trough plasma levels of ssr150106 and its first metabolite.


Eligibility criteria:
inclusion criteria: * either treatment-naïve patients, or those who have discontinued their rheumatoid arthritis-directed medication due to intolerability or insufficient efficacy * at least 9 out of 68 tender joints; 6 out of 66 swollen joints; morning stiffness 45 min * c-reactive protein \>=1.8 mg/dl confirmed during screening period * non-poor cytochrome p2d6 metabolizer status exclusion criteria: * functional rheumatoid arthritis class iv * fever * infections with hepatitis b, or c, or hiv * presence or history (\<5 years) of cancer * manifest or latent tuberculosis * functional abnormalities (including laboratory values) judged as clinically relevant the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Keywords: inflammation anti-cytokine anti-chemokine
effect of a l. paracasei strain on grass pollen allergic rhinitis subjects

Conditions: Allergic Rhinitis

Summary: various studies in animal and humans have shown a potential beneficial effect of probiotics consumption on allergy. however few studies exist that document their efficacy for upper airways allergies such as allergic rhinitis. the objective of this study is to investigate the effect of short-term oral administration of a l. paracasei or of a blend of 2 probiotics (l. acidophilus + b. lactis) on a nasal provocation test (npt) with grass pollen, performed out of the pollen season. adult volunteers with allergic rhinitis are enrolled in a randomized, double-blind study, based on two 4-weeks cross-over periods of product consumption separated by a washout period of 6-8 weeks. objective and subjective clinical parameters of npt as well as systemic and nasal immunological markers are compared before and after each treatment.


Eligibility criteria:
inclusion criteria: * age 18-40 years old * history of allergic rhinitis during the latest grass pollen season confirmed by a positive skin prick test to grass pollen (wheal diameter \> 3mm) and a positive response to a npt with grass pollen (combined nasal reaction threshold \<= 10000 standardized quality units/ml at the screening phase exclusion criteria: * any medical condition that could influence the study (pregnancy, viral or bacterial airway infection, active allergic rhinitis) * uncontrolled asthma (peak expiratory flow \<20% of volunteer's best personal value) * treatment with antihistamine or antibiotic treatment less than two weeks before enrolment or during the trial
culture media for borrelia burgdorferi sensu lato

Conditions: Erythema Migrans

Summary: the main purpose of this study is to compare effectiveness of two different culture media for cultivation of borrelia burgdorferi sensu lato from skin specimens obtained from patients with erythema migrans.


Eligibility criteria:
inclusion criteria: * erythema migrans in patients \> 18 years exclusion criteria: * pregnancy or lactation * taking antibiotic with antiborrelial activity within 10 days * erythema migrans localized on face or neck each patient (235 subjects) provided two skin samples (470 skin samples).

Keywords: erythema migrans lyme borreliosis borrelia burgdorferi skin culture culture media
auriculotherapy for prevention of postoperative urinary retention

Conditions: Analgesia, Epidural

Summary: urinary retention is a common complication of epidural analgesia. auriculotherapy could prevent this complication. this study will be performed among men receiving thoracic epidural analgesia after thoracic surgery.


Eligibility criteria:
inclusion criteria: * patients scheduled to a lung surgical procedure and thoracic epidural analgesia exclusion criteria: * abnormalities of the external ear * dialysis or end stage renal failure * abnormal urinary tract * incapacity to self assessment of comfort and anxiety, * contra-indication to total intravenous anesthesia

Keywords: analgesia, epidural urinary retention
ropivacaine-poloxamer 407 gel for pain control after open gastrectomy

Conditions: Gastric Cancer

Summary: the study evaluates the efficacy of ropivacaine-poloxamer 407 hydrogel in reducing postoperative pain following open gastrectomy.


Eligibility criteria:
inclusion criteria: 1. patients with a histologically confirmed diagnosis of gastric adenocarcinoma prior to surgery. 2. patients who have undergone a complete surgical resection (r0 resection). 3. patients with an asa (american society of anesthesiologists) score of 3 or below. 4. patients aged 20 years or older. exclusion criteria: 1. patients under 19 years of age. 2. presence of ascites or peritoneal metastasis. 3. patients who have undergone preoperative chemotherapy or radiotherapy. 4. diagnosis of malignancies other than gastric cancer. 5. uncontrolled diabetes, autoimmune diseases, hypertrophic scars, or keloid history affecting wound healing. 6. history of allergy or adverse reactions to ropivacaine or other local anesthetics. 7. pregnant women. 8. patients with preoperative chronic pain conditions, including crps. 9. patients with long-term preoperative use of opioid analgesics. 10. patients with psychiatric disorders deemed likely to interfere with study participation. 11. patients with severe liver disease, renal disease, or arrhythmia.
acute effect of motor-cognitive training

Conditions: Injury;Sports

Summary: participants will complete a functional mri to evaluate brain activation, functional connectivity, and behavioral performance immediately before and after a training program (approximately 30 minutes). the training program will comprise of integrate neuromuscular (agility, dynamic postural stability, shuffling, rapid acceleration/deceleration, plyometrics, lateral shuffle, and core stability) and cognitive (reaction time, processing speed, task switching, decision-making, and working memory) challenges.


Eligibility criteria:
inclusion criteria: * physically active exclusion criteria: * injury to the muscle or bone (upper extremity, lower extremity, or back) within the past 3 months * had musculoskeletal surgery or fracture (required open reduction internal fixation or within the last 12 months) * had a concussion or mild head injury within the last year * have been diagnosed with any kind of neurological, vestibular, or visual disturbance that impairs mobility * currently taking medications that affect the central nervous system * pregnant or suspicions of being pregnant * have metal fragments, pins, plates, or clips, shrapnel, body piercings that cannot be removed, have surgical implants or orthodontics that cannot be removed * have claustrophobia * have a history of cognitive impairment

Keywords: injury prevention cognition physical performance athletic training
to determine blood concentrations of ibuprofen and caffeine in a tablet against ibuprofen alone from another tablet

Conditions: Healthy

Summary: the objective of the trial is to compare to combination of 400 mg ibuprofen and 100 mg caffeine against 400 mg ibuprofen alone under fed conditions


Eligibility criteria:
inclusion criteria: * healthy males and females, 18 to 50 years (inclusive) at time of screening. * body mass index (bmi) between 18.5 and 29.9 kg/m2 (inclusive). * body mass not less than 50 kg. * medical history, vital signs, physical examination, standard 12-lead electrocardiogram (ecg) and laboratory investigations must be clinically acceptable or within laboratory reference ranges for the relevant laboratory tests, unless the pi considers the deviation to be irrelevant for the purpose of the study. * non-smokers and mild or moderate smokers (\<= 10 cigarettes or pipes per day). further inclusion criteria apply exclusion criteria: * evidence of psychiatric disorder, antagonistic personality, poor motivation, emotional or intellectual problems likely to limit the validity of consent to participate in the study or limit the ability to comply with protocol requirements. * current alcohol use \> 21 units of alcohol per week for males and \> 14 units of alcohol per week for females. one unit is equal to beer \[200 ml/10 ounces\], wine \[100 ml/4 ounces\], or distilled spirits \[25 ml/1 ounce\]) per day * regular exposure to substances of abuse (other than alcohol) within the past year. * use of any medication, prescribed or over-the-counter or herbal remedies, within 2 weeks before the first administration of imp except if this will not affect the outcome of the study in the opinion of the pi. in this study the concomitant use of hormonal contraceptives is allowed. * participation in another study with an experimental drug, where the last administration of the previous imp was within 8 weeks (or within 5 elimination half-lives for chemical entities or 2 elimination half-lives for anti-bodies or insulin), whichever is the longer) before administration of imp in this study, at the discretion of the pi. * treatment within the previous 3 months before the first administration of imp with any drug with a well-defined potential for adversely affecting a major organ or system. * history of hypersensitivity or allergy (angioedema or urticaria) to the imp or its excipients or any related medication (aspirin or any other nsaid). * diagnosis of hypotension made during the screening period. * diagnosis of hypertension made during the screening period or current diagnosis of hypertension. * resting pulse of \> 100 beats per minute or \< 40 beats per minute during the screening period, either supine or standing. * renal impairment. * positive urine screen for drugs of abuse. in case of a positive result the urine screen for drugs of abuse may be repeated once at the discretion of the pi. further exclusion criteria apply
gene expression profiling in type 1 diabetes

Conditions: Type 1 Diabetes Mellitus

Summary: one of the goals of the kansas city diabetes consortium is to identify and characterize genes and their products that are associated with t1dm. characterization of such genes and their products can aid in developing new tools for risk assessment, development of new prevention strategies and monitoring progression of disease. study design: descriptive, basic science pilot study. the results of this pilot study will be used to help design a much larger study to address the importance of viral response and autoimmune diabetes.

the hypothesis is that viral responsive genes are up-regulated prior to the onset of symptoms of type 1 diabetes (t1dm) and may correlate with increased expression of interferon alpha. both genetic and environmental factors contribute to risk of development of t1dm. there are a number of conflicting reports associating viral infections and t1dm in genetically susceptible individuals and causality has not been proven. viruses may not have a large role in the initiation of islet cell autoimmunity but more of a role in acceleration of the disease leading to overt symptoms. there are no studies describing viral responsive gene expression in these individuals.

Eligibility criteria:
inclusion criteria: * male and female subjects 7-14 years of age * new onset t1dm * five years post onset of t1dm * participant in the trialnet initiative and either antibody positive or antibody negative sibling control * body weight sufficient to tolerate an additional 15ml (1 tbsp) blood loss exclusion criteria: * subjects who do not meet the criteria above * subjects who have received steroids or other immunosuppressive therapy within the 6 months prior to enrollment into the study

Keywords: viral response genes