Kornimate/medical-research-clean huggingface dataset:
efficacy of allopurinol and dypiridamole in acute mania

Conditions: Mania

Summary: this study aims to evaluate the potential antimanic efficacy, safety and tolorability of the purinergic agents allopurinol and dipyridamole as an add-on treatment to lithium in a sample of 180 drug-free manic patients enrolled in a double-blind, placebo-controlled design.

men and women ages 18 to 65 years, who were inpatients with a diagnosis of manic episode were recruited at the emergency room of espirita hospital of porto alegre (hepa), brazil (n=180) between september 2004 and 2006. the presence of manic episode was confirmed using scid-i and the severity of episode was evaluated using the young mania rating scale (ymrs) and the clinical global impression scale (cgi). patients were required to present a score\>22 on the ymrs at screening to be included. subjects presenting rapid cycling, mixed episodes and comorbidities with axis i psychiatric disorders were not considered for inclusion. all subjects presented good physical health determined by physical exam, medical history, blood screening and electrocardiogram. patients were randomly assigned to allopurinol 600 mg/day, dipyridamole 200mg or placebo as add-on medication lithium treatment for a 4-week, double-blind trial. the use of adjunctive antipsychotic agents (typical or second-generation drugs) was not allowed during the double-blind period. adjunctive diazepam was used when necessary (maximum dose=20mg/day). raters (psychiatrists) were trained together to establish reliability (ymrs =0.90). this study was approved by the espirita hospital ethics committee-irb. written informed consent was obtained from all patients and/or family member. possible adverse events were monitored weekly during the follow-up period. regarding primary outcome measures, we compared the percentage of responders according ymrs score decrease of at least 50% among allopurinol, dipyridamole and placebo groups, using fisher exact test. also, the percentage of improvement from baseline to endpoint was obtained and compared among groups using analysis of variances (one-way anova) with duncan post-hoc test. remission rates (ymrs scores \< 12) were also analyzed. p values \< 0.05 were considered statistically significant. besides completers analysis, intention to treat and locf were employed to include data from drop-out patients who were evaluated at visit 3. possible correlations were measured using pearson test. fischer exact test and x2 evaluated response and remission rates. data are presented as mean ± standard deviation.

Eligibility criteria:
inclusion criteria: * the presence of manic episode was confirmed using scid-i and the severity of episode was evaluated using the young mania rating scale (ymrs) and the clinical global impression scale (cgi). patients were required to present a score\>22 on the ymrs at screening to be included.all subjects presented good physical health determined by physical exam, medical history, blood screening and electrocardiogram exclusion criteria: * subjects presenting rapid cycling, mixed episodes and comorbidities with axis i psychiatric disorders were not considered for inclusion. .
quantitative eeg during psg in patients with and without fibromyalgia

Conditions: Fibromyalgia

Summary: the purpose of this study is to retrospectively analyze clinical and nocturnal polysomnographic data (overnight sleep studies) in patients with and without fibromyalgia. fibromyalgia is a pain syndrome associated with dysfunctional sleep, fatigue, frequent awakenings, non-refreshing sleep, and alpha frequency intrusions. quantitative eeg during routine nocturnal polysomnography can be used to assess alpha/delta sleep. hypothesis: alpha intrusions may be an objective marker for fibromyalgia and may correlate with current clinical american college of rheumatology criteria for the diagnosis of fibromyalgia.

this is a retrospective study of patients with and without fibromyalgia seen in private practice from aug 2007-july 2010 who underwent overnight sleep studies (psg) the polysomnographic and clinical data from research subjects with a diagnosis of fibromyalgia will be compared to other subjects' psg and clinical data who were also referred for sleep studies including those with sleep apnea, narcolepsy, periodic limb movement, fatigue, and insomnia which are standard indications for overnight sleep studies. clinical data: clinical data points will include the following: 1. research study number, 2. age, 3. gender, 4. body mass index, 5. epworth sleepiness scale (self reported scale on sleepiness), 6. fatigue severity scale (self reported scale on fatigue, 7. american college of rheumatology (acr) criteria for fibromyalgia, 8. manual tender point exam (# of anatomically specific tender points/18), 9. medications: benzodiazepines (bnz, bnz ), tricyclic antidepressants (tca) and serotonin reuptake inhibitors (ssris snris). sleep study data points: the following data points will be captured from overnight sleep studies: 1. total sleep time, 2. sleep efficiency, 3. wake after sleep onset, 4.apnea/hypopnea index, 5. respiratory distress index, 6. periodic limb movement index, 7. periodic limb movement arousal index, and 8. quantitative eeg: delta event/alpha event ratio.

Eligibility criteria:
inclusion criteria: * completed a polysomnogram * complaints of disordered sleep * age 18 to 80 inclusive * men and women exclusion criteria: * history of seizure * use of benzodiazepines * use of aeds * any significant medical condition other than disorder sleep or fibromyalgia that would influence qeeg measures

Keywords: fibromyalgia qeeg sleep pain
adductor canal nerve block following total knee arthroplasty

Conditions: Post-op Pain

Summary: the purpose of this study is that an adductor canal nerve block (putting numbing medicine near the nerve) has been shown to produce excellent pain relief with less pain medication use after knee replacement surgery.the investigators will be comparing the amount of pain relief following knee replacement surgery when you have a nerve block in place. there will be approximately 66 subjects participating in this study. after surgery subjects will receive numbing medication every 6 hours for 48 hours. subjects will also receive a morphine pca (patient controlled analgesia) after surgery and pain medication by mouth every 4 hours around the clock with the option to receive more pain medication if needed. subjects will participate in the study up to 3 days.


Eligibility criteria:
inclusion criteria: 1. is the subject undergoing primary unilateral total knee arthroplasty? 2. is the subject 18 to 99 years of age? 3. is the subject asa class 1, 2, or 3? 4. does the subject have a bmi less than 35? 5. can the subject consent in the english language? exclusion criteria: 1. does subject have an allergy to drugs used in this study; 2. does subject have a daily intake of opiate medications that are considered stronger than hydrocodone? 3. does subject have a history of alcohol or drug abuse 4. has subject had a previous total knee arthroplasty? 5. has subject had any neurologic deficits in the lower extremity being studied?

Keywords: total knee arthroplasty nerve block pain control after surgery
colorectal metastasis and liver transplantation with organs from deceased donors

Conditions: Colorectal Liver Metastases; Colorectal Adenocarcinoma; Unresectable Malignant Neoplasm

Summary: melodic trial is an prospective, multicenter, non-randomized, open-label, parallel trial, aimed at assessing the efficacy (in terms of overall survival: os) of liver transplantation (lt) in unresecable crc liver-only metastases, compared with a matched cohort of patients bearing the same tumor characteristics, and treated with chemotherapy. synthesis of inclusion parameters: "10;10;10;100"


Eligibility criteria:
inclusion criteria (sythesis: 10;10;10;100): * ≥ 18 and \<70 years * performance status, ecog 0-1 * histologically proved adenocarcinoma in colon or rectum. * braf wild-type crc on primary tumor or liver metastases * high standard oncological surgical resection of the primary tumor * liver metastases not eligible for curative liver resection confirmed by the validation committee * at least one line (3 months) of chemotherapy * no signs of extra hepatic metastatic disease or local recurrence on ct, mri and pet-ct within 4 weeks prior to the faculty meeting at the transplant unit * before start of chemotherapy no lesion should be larger than \> 10 cm * objective response according to recist 1.1 or sd at two consecutive ct without cea increase * patient with less than 10% response on chemotherapy may be included if they obtain al least 20% response after tace (deb-iri) or by 90y-spheres * at least 10 months time span from crc resection and date of being listed on the transplantation list. * satisfactory blood tests hb \>10g/dl, neutrophils \>1.0, bilirubin\<2 x upper normal level, ast, alt\<5 x upper normal level, creatinine and albumin in normal level. * cea\<100 ng/ml * signed informed consent and expected cooperation of the patients for the treatment and follow up exclusion criteria: * weight loss \>10% the last 6 months * patient bmi \> 30 * participation refusal * general contraindication to lt * prior extra hepatic metastatic disease or primary tumor local relapse. * other malignancies in the previous 5 years * pregnancy or breast feeding * any reason why, in the opinion of the investigator, the patient should not participate.
sentinel lymph node biopsy in breast cancer surgery using icg

Conditions: Sentinel Lymph Node; Breast Cancer

Summary: this clinical trial is a prospective, multicenter, self-controlled clinical study. in order to meet the requirements of this plan, 130 breast cancer patients need the sentinel lymph node biopsy with novel near-infarred fluorescence imaging system produced by beijing digital precision medical technology co., ltd. the fluorescence molecular imaging of indocyanine green (icg) on imaging detection and the control group, routine medical using methylene blue test .the safety and efficacy of fluorescence and staining in sentinel lymph node biopsy of breast cancer were compared.

this trial was a prospective, multicenter, and self controlled clinical trial. the subjects who were in line with this scheme were detected by fluorimetry and staining, and the primary effectiveness evaluation index, secondary effectiveness evaluation index and safety evaluation index were established during the operation. record evaluation. at present, in the clinic for sentinel lymph node biopsy of breast cancer, routine medical treatment is a blue staining method. a large number of clinical data show that the number of blue staining methods was 1-2.4, and the number of fluorescence detection is 2-3.7. therefore, choosing a self controlled clinical trial can increase the number of sentinel lymph node detection.

Eligibility criteria:
inclusion criteria: 1. the age of 18-75 years, female patients; 2. the diagnosis of breast cancer by biopsy; 3. participants voluntarily participated in the clinical trial and signed informed consent. exclusion criteria: 1. had received slnb or axillary surgery; 2. breast area radiotherapy or neoadjuvant chemotherapy has been accepted. 3. clinical hints of axillary lymph node metastasis; 4. discovery of distant metastasis; 5. inflammatory breast cancer; 6. women in pregnancy; 7. people with iodine allergy; 8. the serum creatinine was \> 1.5 times as high as the upper limit of the normal value. 9. to participate in clinical trials of other devices or drugs within one month; 10. the researchers consider it inappropriate to participate in this clinical trial.

Keywords: near-infrared fluorescence image guided surgery sentinel lymph node biopsy indocyanine green methylene blue
education of parents about discipline in a way that is culturally sensitive

Conditions: Violence; Parenting

Summary: to determine if a brief primary care intervention can educate under-resourced and minority parents about discipline in a way that is culturally sensitive.


Eligibility criteria:
inclusion criteria: * parents presenting with their children to a pediatric clinic. exclusion criteria: -
the role of laparoscopy in lower gastrointestinal surgical emergencies in adults.

Conditions: Emergencies

Summary: introduction: causes of lower abdominal pain caused by various git emergencies, including acute appendicitis, intestinal obstruction, acute perforated diverticulitis, obstructed hernia, and iatrogenic colon perforation. the role of laparoscopy may be of diagnostic and therapeutic value. methods: between april 2017 and april 2020, 793 patients were admitted to zagazig university hospital's emergency surgery unit with lower git emergencies, including acute appendicitis, acute intestine obstruction, complicated colonic diverticulum, complicated hernias, and iatrogenic colonic perforations.

an acute lower abdomen is typically caused by peritoneal irritation caused by an abdominal organ's inflammation, rupture, or a hollow organ obstruction. patients with severe acute lower abdominal pain either proceed to the operative room or additional investigations or diagnostic laparoscopy (dl). laparoscopy should not be used routinely for every acute lower abdomen case due to anesthetic risks and morbidity . most hospitals do emergency abdominal surgeries, and laparotomy in these procedures is associated with high death rates (14 to 20%) . laparoscopic surgery has become a standard method for abdominal emergencies as a diagnostic and therapeutic tool. it has even been employed in some situations of lower abdominal crises in recent years . the general surgeon frequently faces diagnostic challenges in emergency abdominal conditions. the diagnosis is crucial for planning the appropriate abdominal incision and avoiding unnecessary surgery. noninvasive diagnostic approaches such as radiological examinations are not always conclusive. furthermore, they are costly and cannot be performed 24 hours a day in all hospital circumstances . a retrospective observational study was designed to analyze the outcomes of a laparoscopic technique in emergent lower git surgeries regarding intraoperative and postoperative outcomes.

Eligibility criteria:
inclusion criteria: * \>18 years old, both sexes, and have undergone laparoscopic surgery for acute lower git emergencies such as acute appendicitis, acute intestine obstruction, complicated colonic diverticulum, complicated hernias, and iatrogenic colonic perforations exclusion criteria: * less than 18 years of age and open surgery

Keywords: emergency surgery laparoscopy lower abdominal surgery
confocal microscopy and lacrimal gland in sjogren's syndrome

Conditions: Primary Sjogren's Syndrome

Summary: traditional methodological clinical and instrumental diagnostics of the lacrimal gland for the study of glandular architecture and functions are limited and include analysis of tear constituents, evaluation of apparent diffusion coefficients in magnetic resonance imaging and histopathological evaluation of lacrimal gland biopsy specimens. confocal microscopy is a new emerging technology which is useful as a supplementary diagnostic tool for in vivo assessment of anterior-segment disorders.the use of in vivo confocal microscopy in a comparative study of the microscopic morphology of the salivary/lacrimal glands have not been reported up to date. in this study, we employ laser scanning confocal microscopy to evaluate the morphological changes of the salivary/lacrimal glands in patients with primary sjögren's syndrome and compare the results with those of healthy control subjects.


Eligibility criteria:
inclusion criteria: * the sjögren's syndrome diagnosis was made according to the revised american-european consensus criteria. * briefly, the patients had to have ocular and oral symptoms of dryness, * clinically diagnosed dry eye and dry mouth disease, * serum rheumatoid factor and antinuclear antibody levels ≥1:160, * positive serology for anti ss-a or anti ss-b antibodies, * labial salivary gland inflammatory infiltration focus score ≥2 and consents for lacrimal gland biopsy to be included into this study. exclusion criteria: * patients with any history of ocular surgery including punctal occlusion, * other ocular or systemic disease * or a history of topical/ systemic drug use or contact lens wear or * other systemic disorders that would cause dry eyes or that would alter the ocular surface.

Keywords: dry eye, in vivo confocal microscopy, inflammation, acinar unit density, lacrimal gland
validation of the hyponut product

Conditions: Peanut Allergy

Summary: the hyponut product was previously validated in a laboratory setting ("procédé de préparation d'aliment hypoallergénique", n° fr1250977) on 2012. a international patent was then obtained on 2013. through the present study, the investigators would like to prove that the hypoallergenicity of the product is sustained in a clinical setting. patients allergic to peanuts currently undergo in vivo tests to confirm their allergy: skin prick tests, and oral food challenges. in vitro tests are also performed (i.e. ige levels for peanut and peanut components). the follow-up of patients consists in regular yearly or semestral evaluations. during one of these evaluation, the investigators will skin tests patients with the hyponut product to verify if they are sensitized to this last one as well. when skin tests will be negative, the investigators will propose to patients to take some of the product to verify its tolerability as well.


Eligibility criteria:
inclusion criteria: * patients aged more than 6 * patients suffering from peanut allergy and followed in the allergy unit of the university hospital of montpellier (france) exclusion criteria: * pregnancy, or patients breast-feeding * patients treated with drugs possibly altering the results of the tests (e.g. anti-histamines) * patients presenting with dermographism * patients not fluent in french

Keywords: peanut allergy skin prick test oral food challenge hyponut
pilot study of a catheter-based ultrasound hyperthermia system

Conditions: Cervical Cancer; Prostate Cancer

Summary: rationale: hyperthermia therapy kills tumor cells by heating them to several degrees above normal body temperature. ultrasound energy may be able to kill tumor cells by heating up the tumor cells without affecting the surrounding tissue. implant radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. giving ultrasound hyperthermia therapy after implant radiation therapy may kill more tumor cells. purpose: this clinical trial is studying ultrasound hyperthermia therapy to see how well it works after implant radiation therapy in treating patients with stage iii/iv cancer of the cervix or prostate cancer with a rising prostate specific antigen (psa) after prior local therapy.

outline: patients undergo standard high-dose rate (hdr) brachytherapy. approximately 2 hours after brachytherapy, patients undergo catheter-based ultrasound hyperthermia therapy over 60 minutes. treatment with hdr brachytherapy and hyperthermia therapy repeats within 1-3 weeks. patients may then undergo 2 additional standard hdr brachytherapy sessions. after completion of study therapy, patients are followed at 1 and 3 months.

Eligibility criteria:
inclusion criteria: * patients who are to be given hdr brachytherapy for treatment of solid tumor of the following: * cervical cancer stage iii or iv or * prostate cancer (with rising prostate specific antigen after prior local therapy) * age \>=18 years * eligible for brachytherapy as determined per clinical standard of care. * ability to give written informed consent and willingness to comply with the requirements of the protocol exclusion criteria: * patients who are not candidates for hdr brachytherapy * any condition that compromises compliance with the objectives and procedures of this protocol, as judged by the principal investigator

Keywords: stage iii, iv cervical cancer rising prostate specific antigen (psa) after local therapy
smart walk: a physical activity program for african american women

Conditions: Physical Activity

Summary: the purpose of this project is to test an 8-month, culturally relevant, smartphone-delivered pa program to improve and maintain high physical levels and reduce cardiometabolic disease risk among obese aa women.

a three-phase study will be used to refine and implement an established theory-based culturally relevant physical activity promotion intervention for obese african american women. phase 1 (aim 1a) will include formative research where 25 african american women provide feedback (via 9 focus groups) to further refine the physical activity intervention by specifying the deep structure cultural relevance of the theoretical mediators of self-regulation, self-efficacy, social support, behavioral capability, and outcome expectations.5 phase 2 will focus on technical development of the refined culturally tailored intervention and 1-month demonstration trial of the smartphone-delivered physical activity promotion program. phase 3 (aims 1b and 1c) will test the intervention and delivery strategy in a two-arm randomized trial where 60 sedentary, obese african american women will receive either the 8-month culturally relevant smartphone-delivered physical activity intervention or a 8-month wellness contact control condition

Eligibility criteria:
inclusion criteria: * self-reported african american * insufficiently active ( 60 mins or less of pa per wk measured by exercise vital sign questionnaire) * bmi\>30 * english speaking and reading * own non-kindle smartphone ios 7 or above, or android 2.3 or above exclusion criteria: * concurrent participation in another physical activity, nutrition, or weight loss program * endorsement of an item on the physical activity readiness questionnaire (par-q) unless physical note is provided * pregnant or plans to become pregnant in next 12 months * plans to relocate out of phoenix area in next 12 months

Keywords: physical activity overweight obese exercise women african american smartphone cardiovascular disease risk