Kornimate/medical-research-clean huggingface dataset:
effects of hyperbaric oxygen therapy on middle and inner ear functions

Conditions: Middle Ear Barotrauma

Summary: the goal of this observational study is to measure the effect of hyperbaric oxygen therapy on middle ear pressure in order to predict the risk factors for middle ear barotrauma also, to assess its effects on hearing functions of the inner ear in participant population. the main questions aim to answer are: * is there a change in middle ear pressure before and after exposure to hyperbaric oxygen therapy ? * is there a change in hearing threshold level before and after exposure to hyperbaric oxygen therapy ? the middle ear pressure, eustachian tube functions and the hearing threshold of the participants will be assessed immediately before the fist session and within one hour after the first and tenth sessions.

fifty four patients already treated by hyperbaric oxygen therapy recruited from hyperbaric oxygen therapy center of assiut university hospitals. otoscopic examination for all patients must be done before and after the session , assessment of middle ear pressure and the state of the eustachian tube through doing eustachian tube function tests (valsalva and toynbee tests for ears with intact tympanic membrane and modified inflation - deflation tests for ears with perforated tympanic membrane) by tympanometry for all patients before and after the first session of hjyperbaric oxygen therapy and after completion of the tenth session. assessment of the hearing threshold level of the patients immediately before the first session and after the tenth session of hyperbaric oxygen therapy through doing pure tone audiometry ( air conduction and bone conduction audiometry) and speech audiometry to assess the speech discrimination score for the patients

Eligibility criteria:
inclusion criteria: * patients of at least 18 years old. * patients accept participation in the research. * patients with out history of middle ear diseases. exclusion criteria: * patients under age of 18 years old. * patients have middle ear effusion. * patients refuse to participate in the research.
pegi to improve shared decision-making for breast reconstruction

Conditions: Breast Cancer

Summary: the purpose of this study is to determine the effectiveness of a pre-consultation decision support workshop for breast reconstruction after breast cancer, in facilitating the decision-making process, compared to routine pre-surgical education.

postmastectomy breast reconstruction is becoming increasingly utilized in breast cancer patients to provide surgical restoration of the breast mounds. the breast reconstruction discussions can be highly complex, as there are many different techniques, timing, and complications that are unique to each procedure. however ¼ of women report being dissatisfied with some component of their cancer or reconstructive care. failure of the physician to provide adequate information about treatment options is the most frequent source of cancer patient dissatisfaction and breast reconstruction patients have expressed a need for further information regarding the complex decision to pursue breast reconstruction. in such scenarios of complex medical decision-making, decision support techniques may be an effective solution to information provision and shared decision-making. as a result, the investigators developed a pre-consultation educational group intervention delivered in a group setting for women considering breast reconstruction, with the aims to fill an existing information-gap, promote high-quality decision-making and enhance decision self-efficacy and other decision measures. this study will evaluate the educational group intervention.

Eligibility criteria:
inclusion criteria: 1. patients \> 18 years of age. 2. seeking consultation for delayed post mastectomy breast reconstruction, or prophylactic mastectomy and immediate post mastectomy breast reconstruction for breast cancer prevention. exclusion criteria: 1. chest wall or atypical breast malignancy that require chest wall reconstruction. 2. active invasive or in situ breast cancer. 3. consultation for breast revision or nipple reconstruction only. 4. patient cannot read or write in english. 5. cognitive impairment or uncontrolled psychiatric diagnosis.

Keywords: breast cancer breast reconstruction shared decision making decision support intervention
sepsis assessment in belgian emergency rooms

Conditions: Sepsis; Shock, Septic; Severe Sepsis

Summary: to validate the use of the heparin binding protein (hbp) concentration to assist in the evaluation of patients admitting to the emergency department with suspected infection.

prospective, non-interventional, multi-centre clinical study to assess the clinical validity of the heparin binding protein (hbp) assay to assist in evaluation of patients with suspected infection following emergency department admission. patients presenting to the emergency department with suspected infection will be enrolled to the study and have a blood sample taken. the patients clinical data over a 72 hour period after enrolment will be recorded in the crf. the enrolment sample will then be retrospectively measured for the hbp level and the power of the enrolment hbp level to predict subsequent clinical development over the following 72 hours will be assessed. data analysis shall include area under curve (auc) from receiver operating characteristics (roc) plot against the patient's final clinical diagnosis as well as sensitivity and specificity of the hbp level to predict the final clinical outcome.

Eligibility criteria:
inclusion criteria: * \>18 years of age, * suspected infection (temperature \>38c or clinical evidence of infection), * intention by clinician to start antibiotics exclusion criteria: * none
lidocaine and pain management in first trimester abortions

Conditions: Pain

Summary: the purpose of this study is to examine the effect of lidocaine (a numbing medication) inside the uterus on patient pain during an early abortion, compared to the paracervical block (lidocaine injected on either side of the cervix).

the investigators intend to conduct a randomized, patient-blinded control trial at oregon health and science university and planned parenthood of the columbia willamette. women will be approached about this study after they have made a decision to terminate the pregnancy. the women will be blinded and randomized into one of two study arms. group 1: the investigator will apply pressure with the capped needle of the paracervical block at the cervical-vaginal reflexion at 4 and 8 o'clock. this will approximate the steps involved in a paracervical block without injecting the patient. following this, the patient will receive a 5 milliliter intrauterine infusion of 4% lidocaine using a sterile 3mm novak curette. the infusion will be placed slowly over 3 minutes. group 2: a standard paracervical block (8 milliliter 1% lidocaine at 4 and 8 o'clock at the cervical-vaginal reflection) will be placed. following this, a 3 mm novak curette will be placed in the vagina and held to the external os of the cervix for 3 minutes. the curette will not be placed through the cervix and no infusion will be performed. this will approximate the steps involved in an intrauterine infusion without injecting the patient. during the procedure, women in both groups will be asked to rate their pain at various times using a 10 cm visual analog scale (vas).

Eligibility criteria:
inclusion criteria: * good general health * age\>18years * english speaking * voluntarily requesting pregnancy termination * have an estimated gestation of up to 76 days since the first day of the preceding menstrual period * confirmed by ultrasound * be able and willing to sign an informed consent * agree to the terms of the study * all patients must be premedicated with ibuprofen and valium (per clinic protocols) exclusion criteria: * significant physical or mental health condition * a gestational age of 77 days or more * adnexal mass or tenderness on pelvic exam consistent with pelvic inflammatory disease * patients who require or request iv/intramuscular sedation * patients who refuse ibuprofen, valium and/or paracervical blocks * patients allergic to lidocaine * patients with known hepatic disease * patients weighing less than 100 lbs

Keywords: surgical abortion pain management
alexithymia and attachment style in patients with somatic symptoms

Conditions: Somatic Symptom Disorder

Summary: to evaluate whether emotional awareness, attachment style and the ability to abstract and symbolize (iq) influence the appearance of somatic symptoms. hypothesis: the investigators expect the presence of somatic symptoms linked to the lower ability of emotional awareness, to lower ability to abstract and symbolize and to an insecure attachment style.

somatic symptom disorder (eg pain, weakness, chronic fatigue) represents one of the main reasons why patients seek specialist medical advice. although the symptoms often manifest themselves in a disabling form and there are numerous medical examinations to which patients undergo, these do not seem to find an organic confirmation to their problem and consequently the patients do not receive a specific diagnosis. these are usually transient symptoms but it can happen that they become persistent and chronic, going to constitute themselves as real somatic syndromes. the study investigates the psychological and family aspects that seem to characterize somatic and chronic pain symptoms in pediatric age. in addition to this objective, the study aims to quantify the health costs incurred in the diagnostic phase prior to the classification of the somatic symptom. these elements would make it possible to achieve greater knowledge of clinical pictures and the identification of useful markers for the clinician to make early diagnoses and guide patients in a global and timely care.

Eligibility criteria:
inclusion criteria: * clinical condition characterized by somatic symptoms such as recurrent abdominal pain, recurrent vomiting, dyspepsia, psychogenic cough, and chronic functional pain (headache, migraine, musculoskeletal pain) for which an organic cause has been excluded and whose symptom has had a strong impact on the quality of life (presence of the symptom for six months, school absenteeism, social isolation, immobility, psychological distress, difficulty in participating in sports and extracurricular activities, etc.), as per diagnostic and statistical manual of mental disorders (dsm-5) criteria. * age between 11 and 17 years * italian speaking * patients' and parents' consent exclusion criteria: * cognitive and/or developmental impairment * difficulty in understanding the italian language * presence of organic disease diagnosis * lack of informed consent * patient who does not meet dsm-5 criteria for somatic symptom disorder caregiver exclusion criteria: * cognitive deficits * difficulty in understanding the italian language * lack of informed consent control group population inclusion criteria: * age between 11 and 17 years * adequate knowledge of the italian language * consent to participate

Keywords: somatic symptoms alexithymia attachment style pain reflective function
treatment of short stature with genotropin in children born small for gestational age until final height

Conditions: Growth Disorder

Summary: this trial evaluates whether long-term treatment with genotropin normalizes final (adult) height in short children born small for gestational age


Eligibility criteria:
inclusion criteria: * participation in the 90-080 study exclusion criteria: * any severe, acute or chronic disease * any other identifiable reason for short stature
a phase ii trial of salvage treatment with gemcitabine and s-1 combination in patients with heavily treated advanced colorectal cancer.

Conditions: Advanced Colorectal Cancer

Summary: to assess the efficacy and safety of salvage tratment with gemcitabine and s-1 combination in metastatic colorectal cancer


Eligibility criteria:
inclusion criteria: * non resectable colorectal adenocarcinoma. * disease progression during or within 6months after treatment with irinotecan and oxaliplatin contaning regimens. * estimated life expectancy of more than 3 months. * ecog status 2 or lower exclusion criteria: * other tumor type than adenoarcinoma. * presence or history of cns metastasis. * evidence of gastrointestinal bleeding.

Keywords: colorectal cancer gemcitabine s-1
gut health and probiotics in parkinson's (sympd)

Conditions: Parkinson Disease

Summary: current literature suggests that the gut microbiota is altered in patients with parkinson's disease (pd) and might play a role in the clinical presentation and pathogenesis of this condition. the latter has driven the interest in investigating the use of gut microbiota-modulating interventions, such as probiotics, as possible novel therapeutic strategies for pd. symprove is a food supplement working as an oral active probiotic which unlike many commercially available probiotics can reach the intestine and has been shown to be beneficial for gut health in gastrointestinal disorders.to date, no research has explored the possible effects of the intake of symprove in pd. this is an exploratory study with a randomised, double-blind, placebo-controlled design investigating the effects of a 12-week probiotic intervention (symprove) on gut and general health in 60 patients with pd and constipation.


Eligibility criteria:
inclusion criteria: * age of 18 and upwards * diagnosis of idiopathic parkinson's disease according to the movement disorder society clinical diagnostic criteria * hoehn yarh stage ii-iv * diagnosis of constipation according to the rome iv criteria and ≤ than 3 complete bowel movements per week exclusion criteria: * diagnosis or suspicion of other causes for parkinsonism * advanced-stage therapies (deep brain stimulation, intrajejunal levodopa infusion, and apomorphine subcutaneous infusion) * any inflammatory bowel disease or diseases of the colon * previous surgery on the gastrointestinal tract * history of laxative abuse * ongoing artificial nutrition * regular use of probiotics * previous intolerance and/or adverse reactions to probiotics * previous use of symprove * recent or current use of any antibiotics (within 4 weeks before the start of the study) * swallowing issues interfering with the safety intake of the probiotic/placebo * pregnancy or lactation * major systemic disease * any condition interfering with the ability to give the informed consent * enrolment in another simultaneous investigational trial
real-world observational study on patient-reported outcomes in the treatment of insomnia with daridorexant in canada

Conditions: Insomnia

Summary: the purpose of this observational study is to evaluate the impact of daridorexant on quality of life, work productivity and insomnia symptoms in canadian adults suffering from insomnia.

participating physicians will identify potential participants based on their medical judgment for a new prescription of quviviq® (daridorexant) 50 mg. physicians will discuss with the potential participant in person to briefly describe the study (purpose, confidentiality, questionnaires, as well as compensation). potential participants interested in participating in the study will be asked to give their authorization to share with the proxy network their contact information by signing an authorization form. a designated proxy team member will then contact the potential participant to explain the study in more details and to assess the eligibility. if the potential participant agrees to participate and provides verbal consent, he/she will be invited to visit the participant portal on the proxy website to sign the icf and complete the online baseline questionnaires. five days prior to each study timepoint (1 month, 2 months and 3 months following baseline questionnaire completion), participants will receive an email inviting them to fill their study questionnaires. this e-mail will be sent every other day to the participant who have not completed the questionnaires. in the case where a participant has not completed the questionnaires within a period of 5 days after the first email was sent, a call will be made by a designated proxy team member to remind the patient to complete the questionnaire. participants who don't complete the questionnaires in the 5 days following the call will be excluded from this timepoint analysis.

Eligibility criteria:
inclusion criteria: * signed icf prior to any study-mandated procedure. * has received a first prescription of daridorexant 50 mg to treat insomnia, treatment start has not exceeded 7 days prior to enrollment. * ability to read and understand french or english. exclusion criteria: * patients participating in a clinical trial. * history of daridorexant use in the past (i.e., samples provided by the physician before prescription). * taking a concomitant medication to treat insomnia. * already started daridorexant more than 7 days prior to enrollment.the 7-day period is necessary to allow flexibility between the time of prescription and proxy first contact to participant. beyond this 7-day period, patients may already have experienced benefits from daridorexant. to minimize bias in baseline results, these patients will be excluded.

Keywords: daridorexant dual orexin receptor antagonist real-world observational quality of life work productivity insomnia
efficacy and tolerability of beclomethasone dipropionate/formoterol single inhaler in patients with mild to moderate persistent asthma

Conditions: Asthma

Summary: efficacy and tolerability of the fixed combination beclomethasone dipropionate /formoterol in patients with mild to moderate persistent asthma.

the purpose of this study is to evaluate the efficacy and tolerability of beclomethasone dipropionate/formoterol single inhaler in a twice daily regimen in patients with mild to moderate persistent asthma. patients are randomised to receive either beclomethasone dipropionate/ formoterol single inhaler (total daily dose : bdp/ff 400/24 µg) or beclomethasone cfc (total daily dose : bdp 1000 µg) during 12 weeks of treatment.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of mild to moderate persistent asthma (according to gina 2003 guidelines) * fev1 \> or = 60% and \< or = 85% of predicted normal values * patients free of laba at least for one month before screening and already treated for at least two months with ics and experiencing (i)a daily use of sabas between 1 and 4 puffs, (ii) and/or clinical symptoms three times in the week prior to inclusion * a documented positive response to the reversibility test exclusion criteria: * pregnant or lactating females or women of childbearing potential without any efficient contraception * heavy smokers defined as smoking for \> 10 pack years * evidence of asthma exacerbation causing an hospitalisation or requiring treatment with oral/parenteral corticosteroids or evidence of symptomatic airways infection in the 4 weeks prior to inclusion (3 months for slow-release corticosteroids) * seasonal asthma or asthma occurring only during episodic exposure to an allergen or occupational chemical sensitizer * clinical significant or unstable concomitant diseases, including clinically significant laboratory abnormalities * evidence of asthma worsening during the week preceding randomisation (e.g pef variability \> or = 30% during 2 consecutive days, saba use \> 8 puffs/day during 2 consecutive days, nocturnal awakenings due to asthma symptoms during 3 consecutive days
transcranial magnetic stimulation of the prefrontal cortex: effects on risky decision making and temporal discounting.

Conditions: Decision Making

Summary: the main objective of this study is to examine the effects of magnetic stimulation on the prefrontal cortex. we plan to use low frequency, repeated transcranial magnetic stimulation (1 hz rtms) to temporarily inhibit activity in the prefrontal cortex and measure the resulting effect on two decision-making tasks. the prefrontal cortex is thought to mediate or control cognitive functions like decision-making, planning, memory, and inhibit impulsive behavior.previous research has indicated that rtms over the right dorsal lateral prefrontal cortex will lead to preferences for riskier alternatives. our hypothesis is that rtms over the right dlpfc will lead to greater preference for the riskier alternative and greater temporal discounting.


Eligibility criteria:
inclusion criteria: * healthy participants willing to give informed consent to participate * complete the transcranial magnetic stimulation adult safety screen * have a mri scan * wear ear plugs during rtms * receive rtms over the designated course of days * complete cognitive assessments and decision making tasks. * return for post-testing on all tasks after completing all rtms sessions exclusion criteria: * diagnosed neurological and/or psychiatric disorders requiring hospitalization or medication * pregnancy or the possibility of pregnancy at the time of consent * a history of tinnitus * metal implants in head or neck or a pacemaker * poorly-controlled migraines * a history of head injury, stroke, previous brain neurosurgery, or loss of consciousness due to head injury lasting greater than 10 minutes * a personal or family history of epilepsy or seizures

Keywords: behavior impulsivity transcranial magnetic stimulation
colorectal cancer detection by means of optical fluoroscopy

Conditions: Colorectal Cancer

Summary: the aim of the present prospective study was to investigate the fluorescence emission of human blood plasma of patients with colorectal cancer. for years, serum tumor markers have been studied for the diagnosis and follow-up of colorectal cancer, among which carcinoembryonic antigen (cea) has achieved promising results. however, the sensitivity of cea for colorectal cancer is less than 25% and elevated cea levels also occur in patients with benign disease, as well as in patients with other carcinomas. nevertheless, surveillance programs are often based on the cea test and combination with other markers is at present a matter of research. alternative methods based on optical fluoroscopy have been introduced in experimental stages for clinical diagnosis of cancer. few studies have been reported on the application of native fluorescence spectroscopy of biofluids in the diagnosis of tumoral diseases. the above reported findings prompted us to investigate the fluorescence emission of human blood plasma of patients with colorectal cancer. for this purpose, the blood of patients was collected and the fluorescence preliminary measurements on plasma of patients bearing colon cancer showed that the fluorescence spectra were mainly characterized by the presence of an emission peaking at 620-630 nm, whose excitation spectrum peaked at 405 nm. hence, an excitation wavelength of 405 nm was selected for the study. the fluorescence emission spectra were recorded in the range of 430-700 nm.

eligibility criteria: gastrointestinal disease or clinical symptoms related to colorectal cancer risk submitted to endoscopy. exclusion criteria consisted of age younger than 18 years, history of psychiatric illness, and preoperative radiotherapy. outcome: investigated the possible role of the native fluorescence of blood plasma in the management of colorectal cancer (crc) and its feasibility as a new tumor marker. sample of blood was collected from asymptomatic blood donors and from crc patients. the native fluorescence of blood plasma was measured using a conventional spectrofluorimeter.

Eligibility criteria:
inclusion criteria: gastrointestinal disease clinical symptoms related to colorectal cancer risk endoscopy exclusion criteria: age younger than 18 years or more than 75 years, history of psychiatric illness, preoperative chemo/radiotherapy.

Keywords: adenocarcinoma, colorectal tumors, endogenous porphyrins, fluorescence, tumor markers.