Kornimate/medical-research-clean huggingface dataset:
laparoscopic clip-gastroplasty with the use of bariclip

Conditions: Obesity; Obesity, Abdominal; Surgery

Summary: sleeve gastrectomy, the most commonly performed bariatric surgery procedure, carries limitations both short-term including postoperative complications such as hemorrhage and gastric fistula and long-term such as weight regain and gastro-esophageal reflux. a new procedure has been proposed to overcome many of these limitations: laparoscopic vertical clip gastroplasty (lvcg) with bariclip. primary outcome were major postoperative complications. secondary outcomes included weight loss, incidence of de-novo gerd and comorbidity resolution.

methods. the investigators performed a review of data from a prospectively collected database. all patients submitted to primary lvcg were examined. patients were submitted to lvcg between july 2021 and march 2022. collected data included demographic factors, pre-operative weight, pre-operative bmi, operative time, surgical complications, and clinical outcomes in terms of short and mid-term weight loss.

Eligibility criteria:
inclusion criteria: bmi \> 40 bmi \> 35 and comorbidities bmi \> 30 with poorly controlled diabetes mellitus ii or hypertension exclusion criteria: alcoholism drug addiction psychiatric disease

Keywords: bariclip b-clamp gerd bariatric surgery obesity surgery
conservative treatment for atypical endometrial hyperplasia and early endometrial cancer

Conditions: Atypical Endometrial Hyperplasia and Endometrial Cancer

Summary: exploring the efficacy and pregnancy outcomes of conservative treatment for atypical endometrial hyperplasia and endometrial cancer. study the factors related to predicting treatment efficacy.


Eligibility criteria:
inclusion criteria: * (1) age ≤ 45 years old, strong desire to preserve reproductive function, and no factors of reproductive dysfunction evaluated before treatment; (2) the pathological type is atypical endometrial hyperplasia or endometrial cancer; (3) imaging examination confirmed that the tumor was localized to the endometrium; (4) there are follow-up conditions available.
effects of neuro-stim system on pain, sleep, and opioid use

Conditions: Pain (Visceral, Somatic, or Neuropathic)

Summary: the purpose of this study is to evaluate the ability of neuro-stim system, a non-pharmacologic alternative for pain management, to reduce pain and treat insomnia. neuro-stim system uses electrical current to stimulate neurovascular bundles (nerves) in the ear and possibly the autonomic nervous system.

pain is a complex problem that complicates recovery and rehabilitation after traumatic injury and surgery. the physician must balance pain management therapies against the potential for side effects and complications. most of the treatment options for pain are pharmacological and have the potential for serious side effects and drug interactions. a non-pharmacological treatment would reduce the risk of adverse events and likely enhance the overall multimodal pain plan. the purpose of this study is to evaluate the effectiveness of neuro-stim system (nss), a non-pharmacological option that uses electrical current to stimulate neurovascular bundles (nerves) in the ear and possibly the autonomic nervous system, to treat pain and improve sleep. pain patients will be asked to participate in a study to evaluate the ability of neuro-stim system to reduce pain and to treat insomnia. nss is a federal drug administration (fda) approved device intended to be used for chronic and acute pain.

Eligibility criteria:
inclusion criteria: * subjects must be inpatients (at walter reed national military medical center) at the time of study enrollment and study device placement. * any patient experiencing post-operative pain (visceral, somatic, or neuropathic) and has a pain score (measured via dvprs v2.0) equal to or greater than 4 for at least 3 hours in the past 24 hours. * has an intact external ear where device can be placed * the skin of the ear at placement site must be free of infection * the participant cannot have been on regularly scheduled central acting opioids for more than 30 days continuously leading up to the initiation of the study. however, intermittent, breakthrough opioids are permissible, but the potential subject must have a current opioid prescription. * the participant must have vital signs (hr/breathing/blood pressure) within normal limits. * able to understand english and verbalize their pain level. exclusion criteria: * have inconsistent vital signs (fluctuating, extremely low blood pressure, tachycardia, etc.) * wear any time of implanted electrical device such as a brain shunt, vagal stimulator, pace maker, spinal pain pump, etc. * pregnant (by results of preoperative human chorionic gonadotropin or hcg urine or blood testing) * has a history of skin allergy to metals * unwilling to voluntarily participate * hemophilia * psoriasis vulgaris on ears
longer-term study of ar101 in subjects who participated in a prior ar101 study (arc008)

Conditions: Peanut Allergy

Summary: the purpose of this study is to assess ar101's safety, tolerability and efficacy over an extended dosing period.

this study is enrolling participants by invitation only. this is an open-label, international, longer-term extension study for eligible subjects who have participated in one of the aimmune ar101 clinical studies.

Eligibility criteria:
key inclusion criteria: * prior participation in an aimmune ar101 clinical study or any future clinical study that identifies arc008 as a follow-on study option in the protocol * written informed consent and/or assent from subjects/guardians as appropriate * use of effective birth control by sexually active female subjects of childbearing potential key exclusion criteria: * did not complete a minimum of 3 months of ar101 maintenance therapy if the subject was assigned to ar101 in the parent study * currently receiving or received within 5 years prior to screening any type of peanut or other food allergen immunotherapy, except ar101 or unless allowed in the parent study, and except during the follow-up observation period in this study * discontinued early from the parent study

Keywords: ar101 characterized peanut allergen oit (oral immunotherapy) peanut allergy allergy peanut-allergic children peanut-allergic adults desensitization cpna (characterized peanut allergen)
does omega-3 fatty acid supplementation in pregnancy and during lactation protect the child from allergic disease?

Conditions: Allergies

Summary: the incidence of allergic diseases has increased and a relation between allergy and dietary fatty acids has been proposed. modulation of the maternal immune function during pregnancy may have an impact on future clinical outcomes in the child. the aim of this study was to determine the effects of omega (ω) - 3 long-chain polyunsaturated fatty acid (lcpufa) supplementation during pregnancy and lactation on the development of allergic disease (i.e., allergic eczema) in the child at 2 years of age. pregnant women with allergic disease in their immediate family were supplemented daily with 2.7 g ω-3 lcpufa (n=70) or 2.8 g soybean-oil as placebo (n=75) from gestational week (gw) 25 until the third month of breastfeeding. skin prick tests, detection of circulating specific ige antibodies and clinical examinations of the infants were performed at 3, 6, 12 and 24 months of age. the mothers and children were monitored regarding immune modulatory effects during the entire study period.


Eligibility criteria:
inclusion criteria: * pregnant woman, at 25 weeks of gestation, with allergic symptoms (rhinitis, conjunctivitis, eczema, asthma or food allergy) herself or the father to be or an older sibling exclusion criteria: * soy allergy * fish allergy * treatment with anti-coagulation * commercial omega-3 supplementation

Keywords: randomized placebo controlled double blind omega-3 fatty acids pregnancy childhood allergy cytokines eicosanoids polyunsaturated fatty acids
real-world clinical outcomes and toxicity in metastatic breast cancer patients treated with first or second line cdk 4/6 inhibitors and endocrine therapy

Conditions: Toxicity, Drug; Progression, Disease

Summary: to assess cdk4/6i toxicity and effect on pfs in the egyptian population


Eligibility criteria:
inclusion criteria: * breast cancer patients aged 18 years old or more * female patients * histologically proven invasive breast cancer * histologically proven hr-positive and her2-negative breast cancer * metastatic breast cancer (stage 4 according to ajcc 8th edition 2017) * eastern cooperative oncology group (ecog) performance status (ps) of 0 to 3. * adequate hematological and organs function * patients receiving cdk 4/6 inhibitor combined with endocrine therapy(aromatase inhibitors , gnrh agonists, fulvastrent). as a first or second line treatment exclusion criteria: * - male breast cancer patients * patients in, visceral crisis (defined as : severe organ dysfunction, as assessed by signs and symptoms, laboratory studies and rapid progression of disease ) that are at risk of life threatening complication in the short term. * prior treatment with any cdk 4/6 inhibitor. * history of any other cancer , unless in complete remission with no therapy for a minimum of 3 years. * have active bacterial or fungal infection, or detectable viral infection.

Keywords: breast cancer cdk4/6 inhibitor toxicity pfs
a clinical trial to evaluate the effectiveness of lactobacillus reuteri for periodontitis in a chinese population

Conditions: Periodontitis

Summary: the aim of this study is to determine the efficacy of application of lactobacillus reuteri probiotics therapy on clinical improvement and on microbial shift in chinese periodontitis patients.

periodontitis is a chronic inflammatory disease with a prevalence of 80% in chinese adults, which is the main cause of tooth loss in adults. periodontitis has also been demonstrated to be a risk factor for cardiovascular diseases, diabetes, and many other systemic diseases due to the host immune response elicited by periodontal pathogenic bacteria. in the last decade, probiotics therapy using lactobacillus reuteri has been applied for periodontitis patients in european countries. but no evidence has been provided for its effectiveness in a chinese population. the aim of this study is to determine the efficacy of application of lactobacillus reuteri probiotics therapy on clinical improvement and on microbial shift in chinese periodontitis patients. the influence of probiotics therapy on the host inflammatory cytokines levels in periodontitis patients with systemic diseases is also evaluated.

Eligibility criteria:
inclusion criteria: 1. 18-65 years of age 2. patients diagnosed with periodontitis clinically evident according to international classification of periodontal diseases (2017) with periodontal probing depth ≥4mm, attachment loss of the most severe site in the adjacent area ≥3mm, and imaging bone loss more than 1/3 of the root length 3. natural teeth remaining in the mouth≥ 14 exclusion criteria: 1. patients with any other systemic diseases which likely to alter the progression and course of periodontitis, except coronary disease, diabetes or hypertension. 2. patients with aggressive periodontitis. 3. patients who received any periodontal treatment in the past 6 months 4. pregnant or lactating women 5. patients who smoke 6. patients in the acute phase of an infectious disease 7. patients taking bisphosphonate mediation 8. patients who are on any probiotic, anticoagulants or antibiotic supplements for the past 3 months 9. patients allergic to lactate products 10. patients who are deemed uncooperative
virtual reality in cognitive stimulation therapy for visually impaired older individuals with dementia

Conditions: Dementia Patients

Summary: both visual impairment and dementia are prevalent in the elderly population. cognitive stimulation therapy (cst) is an evidence-based intervention for people with mild-to-moderate dementia. virtual reality (vr) has been used in cognitive rehabilitation. however, the efficacy of cst and the feasibility of incorporating vr into therapy targeting people with dementia and visual impairment (pwdvi) have rarely been explored. the current pilot study addressed two issues: 1) to study the efficacy of conventional cst on pwdvi in different cognitive domains and 2) to explore the feasibility and efficacy of vr-cst on pwdvi in various cognitive domains.


Eligibility criteria:
inclusion criteria: 1. cantonese speakers; 2. suspected or having a medical diagnosis of dementia, with the montreal cognitive assessment 5-minute protocol (moca-5) score ranging from 2 to 17, which is equal to the cantonese mini mental state examination (mmse) score ranging from 10 to 24 by using the conversion table from wong et al, 3. a diagnosis of mild to moderate visual impairment determined by an optometrist, 4. no other disability including physical illness, learning disability and severe hearing impairment that may affect participation in group activity, 5. not currently on psychiatric medication/cognitive intervention, (6) no history of other neurological diseases, and (7) did not receive any prior cst. exclusion criteria: 1. currently on psychiatric medication/cognitive intervention, (6) no history of other neurological diseases, 2. currently on psychiatric medication/cognitive intervention, (6) no history of other neurological diseases, 3. prior exposure to cst
increasing linkage to family planning care for individuals with substance use disorder

Conditions: Family Planning Services; Substance-Related Disorders; Opiate Substitution Treatment; Sexual Health

Summary: this study will utilize mixed methods to develop and assess the feasibility and acceptability of a health educator intervention designed to connect patients in recovery from substance use disorder to reproductive health education and services.

developing effective reproductive health interventions for individuals in treatment for substance use disorder is an important public health priority. in the us nearly half (45%) of all pregnancies are unplanned and studies have consistently found this rate to be much higher among individuals in substance treatment, almost 90%. there is a paucity of research on interventions to support the family planning care of this population. the primary goal of this project is to identify an innovative delivery model to address the family planning needs of individuals of reproductive age in treatment for substance use disorder at an urban integrated safety-net health system. through the use of mixed methods this study will address the following objectives: 1) to describe the family planning experiences and needs of individuals in treatment for substance use disorders (sud) in a representative sample of patients and 2) to assess the feasibility and acceptability of the intervention among study participants. if found to be acceptable, efficacy should be assessed in a randomized controlled trial. a navigator model such as this is generalizable and could be easily integrated into a variety of settings.

Eligibility criteria:
inclusion criteria: * in treatment for substance use disorder at one of the participating clinics; 18-44 years of age; english-speaking; not currently pregnant; able to become pregnant (e.g., no history of hysterectomy, tubal ligation, hysterectomy, menopause); not planning to leave the denver area in the next 3 months. exclusion criteria: * currently pregnant; intoxicated or mentally impaired to the point that one is unable to voluntarily consent to participate and/or respond to the surveys.

Keywords: family planning opioid use disorder patient navigation reproductive health sexual health substance use disorder health education
an rct of oseltamivir in outpatients with cpd: a pilot study.

Conditions: Pulmonary Disease; Influenza

Summary: the proposed pilot study will provide needed data to establish the feasibility of a conducting a large randomized controlled trial as to the effectiveness of the use of oseltamivir early in the course of influenza in outpatients with chronic pulmonary disease.


Eligibility criteria:
inclusion criteria: * clinic patients with physician diagnosed chronic obstructive pulmonary disease * respirologist-diagnosed non-cystic fibrosis bronchiectasis and pulmonary fibrosis (based on appropriate clinical, exposure, and radiological criteria as per american thoracic society guidelines) * participants will be drawn from the respirology clinics and will be randomized if within 72 hours of meeting criteria for influenza-like illness exclusion criteria: * residents of nursing homes * patients who are immunosuppressed * patients on immunosuppressive does (15 mg or more) of prednisone for three weeks or longer
safety and immunogenicity of new formulations of glaxosmithkline biologicals' dtpa-hbv-ipv/hib vaccine (gsk217744)

Conditions: Tetanus; Poliomyelitis; Hepatitis B; Haemophilus Influenzae Type b; Acellular Pertussis; Diphtheria

Summary: this study is designed to evaluate the safety and immunogenicity of new formulations of gsk biologicals' dtpa-hbv-ipv/hib vaccine (gsk217744) when administered as a primary vaccination course to healthy infants at 2, 3 and 4 months of age.

this protocol posting has been updated following protocol amendment 1, february 2011, leading to the update of the exclusion criteria.

Eligibility criteria:
inclusion criteria: * a male or female between, and including, 60 and 90 days of age at the time of the first vaccination. * born after a gestation period of 37 to 42 weeks inclusive. * subjects who the investigator believes that their parent(s)/legally acceptable representative(s) can and will comply with the requirements of the protocol. * written informed consent obtained from the parent(s)/ legally acceptable representative(s) of the subject. * healthy subjects as established by medical history and clinical examination before entering into the study. exclusion criteria: * child in care. * use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period. * chronic administration of immunosuppressants or other immune-modifying drugs since birth. * administration of a vaccine not foreseen by the study protocol, within 30 days prior to the first study visit, or planned administration during the study period, with the exception of oral rotavirus vaccination which is allowed at any time during the study. * concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product. * evidence of previous or intercurrent diphtheria, tetanus, pertussis, polio, hepatitis b, hib and/or pneumococcal vaccination or disease, with the exception of hepatitis b vaccination at birth. * any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination. * family history of congenital or hereditary immunodeficiency. * history of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s). * major congenital defects or serious chronic illness. * history of any neurological disorders or seizures. * administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. * acute disease and/or fever at the time of enrolment.

Keywords: combination vaccine primary vaccination
gene expression profiles and metformin efficacy in type 2 diabetes

Conditions: Type 2 Diabetes

Summary: our general aim is to investigate whether messenger rna (mrna) and/or microrna (mirna) expression profiles in white blood cells, predict metformin monotherapy efficacy in patients with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * type 2 diabetes (duration of diabetes of at least 2 years) * age 40-70 yrs * hba1c \> 6.4 \< 9.0 exclusion criteria: * insulin therapy * contraindications to metformin use

Keywords: type 2 diabetes mellitus metformin efficacy gene expression profiles personalized medicine
an efficacy and safety study of cnto 1275 compared to etanercept in patients with plaque psoriasis

Conditions: Psoriasis

Summary: the purpose of this study is to compare the efficacy and safety of cnto 1275 to etanercept in patients with moderate to severe plaque psoriasis.

this is a multicenter, randomized (study medication assigned by chance), active-controlled, parallel, 3-arm study. patients will be randomly (allocation to treatments available by chance) assigned in 3:5:5 ratio to receive one of three treatments groups. the three treatment groups are: group 1 - cnto 1275 45 mg dosing at weeks 0 and 4, group 2 - cnto 1275 90 mg dosing at weeks 0 and 4, group 3 - etanercept 50 mg two times per week through week 12. the total duration for each participant will be up to 64 weeks (approximately 16 months). the active-controlled portion of the study is from week 0 to week 12 during which the efficacy and safety of etanercept and 2 dose levels of cnto 1275 will be evaluated. treatment after week 12 is dependent on physician's global assessment (pga) response at week 12 and initial treatment assignment. patients will receive 2 subcutaneous injections of cnto 1275 (either 45 or 90 mg doses) or twice weekly injections of etanercept during the first twelve weeks of the study. patients may receive two additional doses of cnto 1275 (either 45 or 90 mg doses) up to week 44.

Eligibility criteria:
inclusion criteria: * have had a diagnosis of plaque-type psoriasis at least 6 months prior to the study * have plaque-type psoriasis covering at least 10 percentage of total body surface area * have a psoriasis area and severity index (pasi) score of 12 or greater and a physician's global assessment (pga) score of 3 or greater at the time of the first administration of study drug * must be suitable for phototherapy or systemic treatment for psoriasis * have failed to respond to or have condition which prevents use of cyclosporine, methotrexate (mtx) or psoralen plus ultraviolet light a (puva) exclusion criteria: * currently have nonplaque forms of psoriasis * have current drug-induced psoriasis * have used any therapeutic agent targeted at reducing interleukin-12 (il-12) or il-23 (interleukins are the substance produced by body in immunological disease like psoriasis) * have received phototherapy or any systemic medications/treatments that could affect psoriasis or pasi evaluation (including, but not limited to, oral or injectable corticosteroids, retinoids, 1,25 dihydroxy vitamin d3 and analogues, psoralens, sulfasalazine, hydroxyurea, or fumaric acid derivatives) within 4 weeks of the first administration of study agent * have used a biologic within the previous 3 months

Keywords: psoriasis cnto 1275 etanercept immune diorder skin disorder
role of genomic imprinting in cancer diagnosis

Conditions: Early Diagnosis; Cancer; Biomarker; Genomic Imprinting

Summary: the current research focus for cancer diagonosis is classical genetics, named "driving genes". however, not all cancer patients have typical genetic alterations, especially at early stage. in the past dacades, accumulating evidences have revealed that more than 80% diseases are closely related to epigenetic changes. the normally silenced copy of imprinted genes are reactivated at early stage of cancers, and finally proceed to copy number variation. this study will screen for a panel of imprinted genes and build quantitative models to assist the diagnosis of multiple cancers.


Eligibility criteria:
inclusion criteria: * patients diagnosed with suspicious cancer by ultrasound, ct or endoscope. * biopsy samples available. * male or female patients aged ≥ 18 years. * participants signed informed consent form. exclusion criteria: * age under 18 years. * severe cardiovascular diseases. * central nervous system diseases. * mental disorder. * pregnant. * individuals unwilling to sign the irb-approved consent form and unwilling to follow the protocol to submit the serial urine for test after surgery.