Kornimate/medical-research-clean huggingface dataset:
comparison of erector spinae plane block vs intravenous lidocaine for chronic pain post mastectomy.

Conditions: Breast Surgery

Summary: patients undergoing breast surgery were divided into two groups: intravenous lidocaine (lido-iv) vs erector spinae block (esp). for lido-iv group, patients received a loading dose of lidocaine than a continuous infusion till the end of surgery. for esp group, an ultrasound guided esp block was perormed before anesthetic induction. persistant pain post mastectomy was assessed by sfm-pq score at 1, 3 and 6 months post surgery.

patients undergoing breast surgery with lymph node dissection were divided into two groups: intravenous lidocaine (lido-iv) vs erector spinae block (esp). for lido-iv group, patients received a loading dose of 1.5 mg/kg of lidocaine than a continuous infusion of 2 mg/kg/h till the end of surgery. for esp group, an ultrasound guided esp block was perormed before anesthetic induction with injection of 30 ml of ropivacaine 3.75%. for both group, persistant pain post mastectomy was assessed by item 5 of bpi score at 1, 3 and 6 months post surgery.

Eligibility criteria:
inclusion criteria: * female patients * patients aged 18 and older * american society of anesthesiologists classification i or ii * patients proposed for planned mastectomy with axillary lymph node dissection. * hemodynamic stability. exclusion criteria: * patient refusal * male gender * history of major surgery within the year. * allergy to local anesthetics * bmi\>40 * hemodynamic instability * patients on long-term analgesics * severe heart and/or kidney damage * neurological/psychiatric impairment
physical therapy vs surgical decompression for lumbar spinal stenosis

Conditions: Spinal Stenosis

Summary: this is a randomized controlled multicenter trail comparing physical therapy to surgical decompression in patients with lumbar spinal stenosis. the 0-hypothesis is that there is no difference in the efficacy of structured physical therapy compared to surgical decompression. our aim is to evaluate if physical therapy can serve as a nonsurgical alternative for patients with lss, where the severity of symptoms indicates the need of surgical decompression.


Eligibility criteria:
inclusion criteria: * patients describing intermittent neurogenic claudication when walking and symptoms revealed by flexion of the spine. * mri shows lumbar spinal stenosis in one or two levels measured. * the duration of the symptoms is longer than six months * the patient is a candidate for surgical treatment * the patient is capable of physical exercise exclusion criteria: * vascular intermittent claudication * lumbar spinal stenosis in more than two levels * previous low back surgery * symptomatic lumbar disc herniation * degenerative scoliosis with cobbs angle 30 degrees or more * degenerative spondylolisthesis grade 2 or more * spondylolysis with spondylolisthesis * recent osteoporotic fractures in the spine (last 6 month) * severe symptomatic arthrosis in hip or knee * locally advanced or metastatic cancer * asa \>3 * polyneuropathy recognized by neurography * insufficient norwegian language skills

Keywords: surgery physical therapy modalities
buccal bone resorption in immediate slactive implant placement thin vs. thick buccal bone

Conditions: Dental Implant; Immediate Implant

Summary: the utilization of slactive implants which allow more rapid osseointgeration with 3 to 4 weeks. will be placed in thin buccal bone as immediate implants to determine the resorption compared to thick buccal bone

with the increased demand for aesthetics and the expectation of immediate tooth replacement, improving the treatment options in case with hopeless teeth in the esthetic zone by immediate implants is a need by both practitioners and patients. current guidelines, today, restricting such treatment to only thick (+ or = 1mm) buccal bone plates. however, the literature shows that less than 10% of the community have such criteria, making it a high risk but needed procedure. soft tissue and bone remodelling after extraction is an inescapable fact. immediate implant placement cannot prevent soft tissue and bone remodeling around implants (araújo et al. 2005, chen et al. 2009), but implant surface treatment and modifications might enhance the maintainability of the supporting structures around the dental implant due to its faster integration, better stimulating the vascular components at the site. this could be tested by the crestal and buccal bone changes, pink esthetic score and ostell readings.

Eligibility criteria:
inclusion criteria: 1. single bounded irrestorable tooth in the esthetic zone that needs to be extracted. 2. healthy systemic condition. 3. type i socket with a minimum of 1mm of buccal bone thickness prior to extraction. (morton et al., 2014) 4. sufficient bone apical to the socket for implant primary stability. (morton et al., 2014) 5. good oral hygiene. 6. patient accepts a minimum of three-year follow-up period (cooperative patients). exclusion criteria: 1. signs of acute infection related to the area of interest. 2. patients with parafunctional habits (lobbezoo et al. 2006 and roelhing et al. 2016). 3. smokers (lambert et al. 2000). 4. pregnant females.

Keywords: immediate implant esthetic zone buccal plate slactive
immunogenicity and reactogenicity of alternative schedules of gardasil

Conditions: Dose Schedule Study

Summary: to demonstrate that gardasil® vaccine, when given to girls 11-13 years of age according to 1 of 3 alternative 3-dose schedules (0, 3, 9 months; 0, 6, 12 months; or 0, 12, 24 months), results in anti-hpv type 16 and anti-hpv type 18 responses 28 days post-dose 3 that are similar to those obtained when the vaccine is given on the standard 3-dose schedule of 0, 2, 6 months.

objectives: primary objective: to test the hypothesis that gardasil® vaccine, when administered to girls 11-13 years of age according to 1 of 3 alternative 3-dose schedules (0,3,9 months; 0,6,12 months; or 0,12,24 months), results in anti-hpv 16 and anti-hpv 18 responses 28 days post-dose 3 that are similar to those obtained when the vaccine is administered on the standard 3-dose schedule of 0,2,6 months. secondary objectives: 1. to test the hypothesis that gardasil® vaccine, when administered to girls 11-13 years of age according to 1 of 3 alternative 3-dose schedules (0,3,9 months; 0,6,12 months; or 0,12,24 months), results in anti-hpv 6 and anti-hpv 11 responses 28 days post-dose 3 that are similar to those obtained when the vaccine is administered on the standard 3-dose schedule of 0,2,6 months. 2. to describe the safety profile of the administration of gardasil® according to each of the four schedules by assessing: (i) immediate reactogenicity (reactions within 30 minutes after each injection); (ii) solicited (local reactogenicity and fever) and unsolicited events occurring during the first 7 days following each vaccination; (iii) serious adverse events occurring up to one month following the last dose of vaccine; (iv) deaths or adverse events occurring at any time determined to be vaccination-related.

Eligibility criteria:
inclusion criteria: 1. 11-13 years of age. 2. signed informed consent form (both parent's \& daughter's signature). 3. good health status. 4. able to comply with trial protocol. 5. plans to stay at current school for duration of study. exclusion criteria: 1. prior hpv vaccination 2. pregnant or lactating or intends to become pregnant during study period. 3. apparent moderate or severe acute illness. 4. clinical history of bleeding disorder such as hemophilia, thrombocytopenia, or anticoagulant therapy. 5. clinical history of impaired immune responsiveness, whether due to use of immunosuppressive therapy, a genetic defect, hiv infection, or other causes. 6. hypersensitivity to the active substances or to any of the excipients of the hpv vaccine, or such reactions to other vaccines received in the past. 7. investigational drug or investigational vaccine administered during the period from 30 days before to 30 days after any dose of hpv vaccine.

Keywords: gardasil human papillomavirus hpv vaccine cervical cancer
novel deep brain stimulation in ventral capsule and stratum for refractory obsessive-compulsive disorder

Conditions: Obsessive-Compulsive Disorder

Summary: refractory obsessive-compulsive disorder (ocd) is a disabling condition. deep brain stimulation (dbs) of ventral capsule/ventral striatum(vc/vs) is potentially the most effective treatment for refractory ocd. however, the affecting area of traditional electrodes is limited and not specific to vc/vs. the investigators designed a novel electrode, 2 mental contacts(3mm contact-2mm space-3 mm contact) could be implanted in ventral striatum and the other upper 2 contacts(4mm space-3mm contact-4mm space-3mm contact)that can be implanted in ventral capsule simultaneously, which the investigators believe will be more effective due to better compatibly with anatomical features of target area. this trial is to evaluate the effectiveness and safety of this approach.


Eligibility criteria:
inclusion criteria: 1. age between 18 and 65 years. 2. a primary diagnosis of ocd, defined according to the criteria of the diagnostic and statistical manual of mental disorders, fifth edition (dsm-v). 3. chronic: at least a 3-year history of ocd symptoms with psychosocial dysfunction 4. severity: a score on the yale-brown obsessive compulsive scale (y-bocs) of more than 25 or one subscale score of more than 15 ; a score for severity of illness on the clinical global impression (cgi) scale of more than 4. 5. disability: a score on the global assessment functioning (gaf) scale of less than 45 or a score on sheehan disability scale more than 24. 6. refractory: a lack of response to drug therapy after adequate administration, defined as more than two types of serotonin reuptake inhibitors at the maximum tolerated dose for more than 12 weeks. adequate behavior therapy, defined as more than 20 sessions psychotherapy with experienced therapist. 7. ocd medication regimen is stable for at least 4 weeks before enrollment. exclusion criteria: 1. schizophrenic disorder; bipolar disorder; substance abuse or dependence (except for dependence on nicotine), as assessed with the use of the mini-international neuropsychiatric interview (mini 6.0.0). 2. cluster a or b personality disorder according to dsm-iv-tr criteria, as assessed with the use of the structured clinical interview ii. 3. a current severe major depressive episode, determined according to dsm-v criteria (as assessed with the use of the mini 6.0.0) and defined by the hamilton depression rating scale-17 (hamd) score of more than 20 and a risk of suicide. 4. abnormal cognitive status (measured by moca), abnormal findings on functional magnetic resonance imaging (mri) of the brain, or contraindications to surgery or anesthesia.
ecc5004 rba fe study in healthy participants

Conditions: Type 2 Diabetes Mellitus

Summary: this study is a phase 1, open-label, randomized, single dose, fixed sequence, crossover study designed to compare the relative bioavailability of 50 mg ecc5004 current tablet formulation (f1) and 50 mg ecc5004 new tablet formulation (f2) under fasted and fed conditions in healthy participants

eligible participants will be randomized to one of the two fixed treatment sequences with four treatment periods. in the first two treatment periods under fasted conditions, participants will fast for a minimum of 10 hours, then they will receive a single dose of 50 mg ecc5004 f1 or 50 mg ecc5004 f2. in the subsequent third and fourth treatment periods under fed conditions, participants will consume completely a high fat breakfast followed by administration of a single dose of 50 mg ecc5004 f1 or 50 mg ecc5004 f2

Eligibility criteria:
inclusion criteria: * healthy male and female participants of non-childbearing potential * age of 18 to 65 years * bmi of 18.0 to 32.0 kg/m2 * female participants who are postmenopausal, confirmed by fsh test, or surgically sterile, confirmed by medical documentation, or agree to practice true abstinence * male participants agree to use contraception, or agree to practice true abstinence * no clinically significant findings in physical examination, 12-lead electrocardiogram (ecg), vital sign measurements, clinical laboratory evaluations, concomitant medications, or medical/psychiatric history * able to understand and sign and date informed consent exclusion criteria: * females who are pregnant, planning to become pregnant, or breastfeeding during the study or within 3 months after the study. * concomitant participation in any investigational study of any nature * blood loss of non-physiological reasons ≥ 200 ml (i.e. trauma, blood collection, blood donation) within 2 months prior to the first dose of study drug, or plan to donate blood during this trial and within 1 month after the last dosing * serum calcitonin \> 20 ng/l * clinically relevant acute or chronic medical conditions or diseases of the cardiovascular, gastrointestinal, hepatic, renal, endocrine, pulmonary, neurologic, psychiatric, immune or dermatologic systems * individual or family history of medullary thyroid carcinoma (mtc) or multiple endocrine neoplasia 2 (men2), or suspected mtc * history of pancreatitis * significant allergic reaction to active ingredients or excipients of the study drug * any clinically significant abnormal findings in the participant's physical examination, laboratory tests, pregnancy test, urine drug screen, alcohol test, or medical history which in the opinion of the investigator would prevent the participants from participating in the study.
electrical stimulation in diabetic peripheral neuropathy

Conditions: NMES; Control

Summary: to assess the effect of the device on the progression of diabetic peripheral neuropathy

diabetes is a metabolic disease that affects the body's ability to control blood sugar levels. this affects the tissues of the body, particularly the walls of blood vessels. people with diabetes are more likely to suffer from ischaemic heart disease, stroke, kidney problems, blindness, foot ulcers, and peripheral nerve problems. diabetes affects approximately 347 million people worldwide, and by 2030 the who projects that complications of diabetes will be the 7th leading cause of death. peripheral neuropathy is a dysfunction of the nerves most commonly affecting the arms and legs. diabetes is the leading cause of neuropathy in the western world, and diabetic neuropathy is estimated to affect between 20-50% of diabetic people. the american diabetes association define it as the 'presence of symptoms and signs of peripheral nerve dysfunction in patients with diabetes after exclusion of other causes'. as regards complications of diabetes, peripheral neuropathy has the greatest detrimental effect on quality of life. diabetic neuropathy is implicated in 50-75% of non-traumatic amputations. the device to be tested mimics the effect of walking by stimulating the motor nerves of the leg, making the foot twitch- it increases blood flow to the limb and exercises the leg muscles. we have seen previous clinical cases of improvement in peripheral neuropathy with use of the device, and wish to formalise the benefits to patients. it is hypothesised to work either by increasing blood flow to the limb and therefore the nerves themselves, or for electrical current to be having a direct effect on the peripheral nervous system itself. the device is easily fitted, can be self-administered by patients, and is suitable for out-patient therapy. we wish to evaluate both the short- and longer-term effects of a neuromuscular stimulator on diabetic peripheral neuropathy as a therapeutic intervention.

Eligibility criteria:
inclusion criteria * 18+ years old * diabetes as defined by who diagnostic criteria on best medical therapy * diabetic peripheral polyneuropathy present, confirmed by nerve conduction testing exclusion criteria * pregnancy * pacemaker * metal implants in the legs (below knee)

Keywords: nmes diabetic peripheral neuropathy
the effect of gluten-free diet on parkinsonism

Conditions: Parkinson Disease; Multiple System Atrophy; Non-celiac Gluten Sensitivity

Summary: recent data suggest that the brain-gut axis, chronic intestinal inflammation and microbiome may contribute to the pathogenesis of neurodegenerative diseases with alfa-synucleinopathy, which include parkinson's disease (pd) and multiple system atrophy (msa). environmental factors e.g. diets, microbiome, metabolites and immune mechanisms may play important role in pathogenesis of these diseases. in the human arm of this project, the investigators will address effects of an anti-inflammatory gluten-free diet (gfd) on motor and non-motor symptoms as well as its effects on immune and metabolomic characteristics in patients with pd and msa. in the mouse arm, the investigations will focus on the effects of gfd in chronic mptp-induced mouse model of pd in various settings (e.g. in young or aged animals, with respect to the lengths of exposure to gfd). the chronic mptp model will be used to assess the effects of gfd on adaptive and immune characteristics, and metabolic signatures. using germ-free animals, the microbiome-dependency of the gfd-mediated effects may be determined. the anti-inflammatory gluten-free diet and its related mechanisms represent novel, promising and relatively straightforward approach in a search to improve symptoms of pd as well as msa or even in their prevention.

this project is based on two research lines, testing the effect of gluten-free diet in a patients with pd and msa (a human prospective trial) and in the chronic mptp (1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine)-induced mouse model of pd. research line 1. assessments of effects of gluten-free diet (gfd) on clinical symptoms of parkinson's disease (pd) and multiple system atrophy (msa) in a prospective, controlled, randomized, rater-blinded human study. the goal of the research line 1 is to assess the effects of 12 months of administration of gfd on clinical symptoms of pd and msa. research line 2. effects of gfd on the development of pd in the chronic mptp-induced mouse model of pd. the goal of the research line 2 is to study the effects of gfd in the chronic mptp-induced mouse model of pd in order to evaluate its impact on clinical development of pd's features as well as immune and metabolomic characteristics that should shed more light on the possible mechanisms and potential novel treatment opportunities.

Eligibility criteria:
inclusion criteria: * subjects with establish diagnosis of pd in clinical stage 2-4 of hoehn\&yahr scale or with establish diagnosis of msa * stable treatment for \>4 weeks * willing and able to give informed consent for participation in the study * male and female subjects, aged 40 years or older * able to understand and willing to comply with study procedures * willing to avoid any other diet restrictions * bmi 18-30 exclusion criteria: * concomitant neurological, gastrointestinal or immunological disease * diet restriction * dementia affecting compliance * acute psychiatric symptoms

Keywords: parkinson disease multiple system atrophy gluten-free diet
effectiveness of mobile phone-based intervention to prevent smoking relapse among recent smoking quitters

Conditions: Smoking Cessation

Summary: main objective the main objective of the study is to investigate the effectiveness of a mobile phone-based intervention in reducing relapse ate among recent quitters who are attending the smoking cessation program in jazan. besides this, the study will achieve the following objective: to identify the timing and different factors associated with relapse process among recent quitters during first 6 months of quitting.

background: smoking remains a major public health problem and an important cause of morbidity and mortality worldwide. although the effectiveness of behavior support and medical treatment, many of those who quit smoking subsequently relapse to smoke. objective: the primary aim of this study will be to determine the effectiveness of the mobile phone-based intervention to prevent relapse among recent smoking quitters. also, the study aims to identify the different factors associated with relapse among recent quitters during the first 6 months of quitting. design and methods: a parallel two-armed randomized controlled trial (rct) to assess the effectiveness of a mobile phone-based intervention for smoking cessation on achieving long term abstinence, will be conducted among volunteers. participants will be recruited from those attended smoking cessation program in southern alrawdha clinic, southern abo arish clinic, sabia clinic and aldhabia clinic. primary outcome: the difference in relapsing rate among recent quitters, which may subsequently contribute in to a reduction in smoking rates. trail implications for public health: the result of this study will provide evidence for effectiveness of the mobile phone-based intervention versus standard treatment to reduce smoking relapse rate. if proven, it will be a cost-saving intervention by reducing repeat use of the smoking cessation clinic services and by reducing use of healthcare services for smoking-related illness.

Eligibility criteria:
inclusion criteria: * aged 18 years or older. * recent quitters (24 hours smoking abstinence) * willing to provide informed consent to participate in the study. exclusion criteria: * those suffering any physical or mental disorders. * illiterate people. * pregnant.
cytokine-associated depression and social pain

Conditions: Depression

Summary: recent research has demonstrated a relationship between depression and immune system activity, specifically proinflammatory cytokine activity. although experimentally-induced immune activation leads to increases in depressed mood, the neural correlates associated with these changes have remained largely unexplored. based on relationships between cytokine activity, depression, and heightened physical and social pain sensitivity, i propose to investigate the effect of proinflammatory cytokine activation on the neural correlates of socially painful experience that may contribute to depression. our previous work has shown that the dorsal anterior cingulate cortex (dacc), typically associated with physical pain distress, also plays a role in the distressing feelings associated with social rejection or social loss. moreover, recent pilot data has revealed that individuals with elevated levels of baseline proinflammatory cytokines report feeling more distressed and show more dacc activity during social rejection. to investigate the causal role that cytokines may play in the heightened social pain sensitivity that can contribute to depression, participants will be randomly assigned to receive either endotoxin (which increases proinflammatory cytokine activity) or placebo. subsequently, participants will complete a neuroimaging study in which they will be rejected during an online ball-tossing game. we hypothesize that individuals exposed to endotoxin will report more social distress and depression following rejection and will show more dacc reactivity during rejection. the proposed study is the first to investigate the effect of systemic inflammation on neural reactivity related to social and affective processes that may increase the risk of depression.


Eligibility criteria:
inclusion criteria: * right-handed exclusion criteria: * 1) bmi greater than 30, * 2) presence of physical health problems or medication use, * 3) evidence of an axis i psychiatric disorder based on the scid assessment, * 4) evidence of recreational drug use from a positive urine test, * 5) positive pregnancy test, if female, * 6) abnormalities on screening laboratory tests (blood cell count, liver function), * 7) claustrophobia, * 8) metal in body, * 9) history of allergies, autoimmune, liver, or other severe chronic diseases, * 10) current use of prescription medications, * 11) nightshift work or time zone shifts (\> 3hrs) within the previous 6 weeks.

Keywords: effect of inflammatory challenge on depressed mood effect of inflammatory challenge on social pain