Kornimate/medical-research-clean huggingface dataset:
l.fermentum cect5716 in treatment of breast pain

Conditions: Breast Pain

Summary: the main objective of this intervention study is to evaluate the efficacy of lactobacillus fermentum cect5716 to reduce the presence in the milk of genera staphylococcus and streptococcus as risk factors for mastitis in women with breast pain

1. type of study nutritional intervention study, multicenter, randomized, blinded, parallel group included 25 women per group * group 1: 3x109 cfu / day (n = 25) * group 2: 6x109 cfu / day (n = 25) * group 3: 9x109 cfu / day (n = 25) * group 4: placebo (n = 25) 2. statistical calculation of sample size. the calculation of sample size was calculated by the company seplin solutions statistics. the primary endpoint was the bacterial count of in milk. the sample size obtained to observe a difference of 1 log10, with a power of 0.80 and a significance level of 0.05 was 20 volunteers per group. 3. randomization randomization was performed using a list of random numbers generated by computer. subjects will be randomized in a strictly sequential. if a subject is removed from the test, the number that was assigned randomization not be reused again. 4. overall design and outline of the study at visit 1 we require the informed consent of the patient. it will take the milk sample, we will review the implementation of the inclusion and exclusion criteria. be randomized and explain the treatment guidelines to be followed, the data to be collected and medical appointments that must go (2 and 3 weeks). it will complete the pain assessment questionnaire (mqp) and nutrition survey. on visits 2, 3 and 4 corresponding to 1, 2 and 3 weeks of intervention will collect milk sample pain assessment survey and nutrition survey. milk samples (5 ml) were collected aseptically in sterile tubes to be frozen immediately until analysis to be carried out within seven days. 5. intervention duration the intervention will last three weeks.

Eligibility criteria:
inclusion criteria: · breast-feeding women * swelling and / or warmth in the chest * chest pain * total bacteria count in milk greater than or equal to 3 log10 colony forming units (cfu) / ml, exclusion criteria: * breast abscesses, raynaud syndrome, * antibiotic treatment * allergic to antibiotics * low expectation of compliance with the study protocol.

Keywords: breast pain probiotic mastitis lactobacillus fermentun staphylococcus
ultrasling quadrant versus bledsoe arc shoulder brace

Conditions: Shoulder Injuries and Disorders

Summary: shoulder orthoses are an essential component of both, postoperative care as well as a range of conservative treatment concepts, and thus influence the functional outcome of a wide spectrum of glenohumeral pathologies. therefore it is important to look at them in greater detail. a new concept, designed by djo global in the "ultrasling quadrant®" orthosis now immobilizes only the glenohumeral joint, while giving the possibility of elbow movement. it also allows multiple settings concerning the position of the glenohumeral joint like internal rotation as well as neutral or external rotation. it is yet to be seen how these changes will influence the outcome of therapy as well as how they will change the patient's perception of the orthosis and its wearing comfort. therefore it is planned to be compared to another multifunctional shoulder brace already established on the domestic and international market, the bledsoearc® brace. the primary objective is to assess if one of the investigated shoulder braces ultrasling quadrant® or bledsoe arc® is perceived by patients who received shoulder surgery as superior in terms of higher wearing comfort when worn during the post-operative immobilization period.


Eligibility criteria:
inclusion criteria: * adult patient (18 years or older) * presence of one of the following defined shoulder pathologies with the corresponding surgical treatment: * patients with isolated supraspinatus repairs in double row technique with or without biceps treatment * recurrent anterior instability without significant bone loss and arthroscopic bankart repairs with three anchors * rockwood type v injury treated with arthroscopic-assisted low-profile tightrope repair plus ac-cerclage * patients with rotator cuff arthropathy treated by reverse shoulder prosthesis * signed informed consent to participate in the study exclusion criteria: * non-tolerance of one of the braces (e.g. allergy to textile component) * presence of concurrent pathology of the contralateral arm , that interferes with the immobilizing treatment * presence of another physical disability or health disorder (e.g. psychological disorders, dementia, ...) that make the handling of the braces more difficult or impossible * patient perceived as being at risk of poor study compliance * occurrence of an intra-operative adverse event likely to influence the post-operative immobilization and its evaluation * inability to understand and speak german * enrolment of the investigator, his/her family members, employees and other dependent persons
strategies to improve appropriate referral to rheumatologists

Conditions: Rheumatic Disease; Arthralgia

Summary: the aim of this cluster randomized controlled trial is to improve the number of effectively referred patients with ird to the rheumatology outpatient clinic with either use of validated referral pro formas or triage of ird by specialists in a primary care setting compared to usual care. in addition, the investigators want to provide tools for the general practitioner to recognise ird and improve early referral of patients with ird, and a cost-effectiveness analysis will be performed to evaluate the decreasing effect on health-care cost.

rationale: currently, only 22% of all patients referred to the rheumatologist by primary care are diagnosed with an inflammatory rheumatic disease (ird). previous research has shown that structured referral sheets and community-based specialist service improve appropriateness of referrals. objective: the aim of this study is to improve the number of effectively referred patients with ird to the rheumatology outpatient clinic with either use of validated referral pro formas or triage of ird by specialists in a primary care setting compared to usual care. in addition, the investigators want to provide tools for the general practitioner to recognise ird and improve early referral of patients with ird, and a cost-effectiveness analysis will be performed to evaluate the decreasing effect on health-care cost. study design: cluster randomized trial with randomization of general practitioner clinics. study population: primary care patients of 18 years or older who are suspected of an ird and considered by a gp for referral to a rheumatologist. intervention: one group of gps will use a standardized referral strategy for ird, another group will consist of triage by a rheumatologist in the local primary care clinic, the third group is usual care. main study parameters/endpoints: percentage of patients diagnosed with an ird by a rheumatologists after 12 months. in addition, cost effectiveness, quality of life, work participation and health care costs at baseline and after 12 months. nature and extent of the burden and risks associated with participation, benefit and group relatedness: there is no additional risk to participating patients. patients might benefit from early referral since the referral pro formas point out important aspects of ird that are frequently overlooked. patients will be requested to fill in three online questionnaires related to quality of life, work participation and socio-economic costs. there are no additional visits, physical examinations or other tests.

Eligibility criteria:
inclusion criteria: * a primary care patient who is referred by the gp to the rheumatology outpatient clinic * subject must be able to understand and communicate with the rheumatologist * participant must give a written signed and dated informed consent before enrolment. exclusion criteria: * limited understanding of the dutch language. * legally incapable or vulnerable subject as described in the medical research with human subjects act (wmo).

Keywords: referral primary care rheumatologist
a clinical comparison in cervical epidural pressure changes between midline and paramedian approaches

Conditions: Herniated Nucleus Pulposus; Whiplash Injury

Summary: ligamentum flavum in the cervical region is thin or not fused at the midline. the investigators inferred that the size and elasticity of the ligamentum flavum, in combination with mildline appraoch, the gaps could be responsible for a failure to recognize a lor in some patients. if so, the investigators hypothesized that the paramedian approach would be advantageous for finding cervical epidural space more easily during cervical epidural steroid injections (cesis).

ligamentum flavum in the cervical region is thin or not fused at the midline. the distinct elastic resistance offered by the ligamentum flavum before entering the epidural space when using the loss of resistance (lor) technique may be blunted or even absent. the investigators inferred that the size and elasticity of the ligamentum flavum, in combination with mildline appraoch, the gaps could be responsible for a failure to recognize a lor in some patients. if so, the investigators hypothesized that the paramedian approach would be advantageous for finding cervical epidural space more easily during cervical epidural steroid injections (cesis). therefore, the investigators randomly divide our patients into 2 groups; the midline approach group and the paramedian group. then, the investigators examine the patterns of the pressure changes at the moment of a puncture of the ligamentum flavum during cesis.

Eligibility criteria:
inclusion criteria: * age 20 to 80 yr * cervical radicular pain caused by herniated nucleus pulposus, spinal steonosis, or other conditions, including herpes zoster-associated pain and whiplash injury for more than 3 months * pain intensity \> 4 of maximum 10 nrs * failure to improve with conservative treatment * cervical epidural location of needle confirmed by the fluoroscopic images exclusion criteria: * acute infection * patient refusal * previous cervical spine surgery * structural spinal deformities or a space-occupying epidural mass * rapidly worsening pain, numbness, weakness, hyperreflexia, changes in bladder function, and other neurological symptoms that should prompt a reevaluation and surgical evaluation * pregnancy * allergy to contrast media or drugs to be used in the procedure
exercise capacity muscle oxygenation and arterial stiffness in children with pulmonary arterial hypertension

Conditions: Pulmonary Arterial Hypertension

Summary: the primary aim is to evaluate pulmonary function, respiratory muscle strength, upper and lower extremity exercise capacity, muscle oxygenation, dyspnea, peripheral muscle strength, arterial stiffness, physical activity level and balance in children with pulmonary arterial hypertension and compare with age- and sex-matched healthy controls. the second aim is to investigate the relationship between upper extremity exercise capacity, arterial stiffness, respiratory and peripheral muscle strength

pulmonary arterial hypertension (pah) is defined as higher than 25 mmhg in mean pulmonary arterial pressure at rest. pulmonary arterial hypertension is chronic and progressive disease. symptoms such as dyspnea, fatigue, exercise intolerance, cyanosis and syncope are shown in children with pah. most common symptom is dyspnea during exertion. dyspnea at rest could occur while the severity of disease is progressed. all these symptoms have been associated with decreased cardiac output and mismatch oxygen transport. this study is planned as a cross-sectional study. at least 13 children with pah and at least 13 age- and sex- matched healthy controls will be included in this study. individuals' pulmonary function (spirometer), respiratory muscle strength (mouth pressure device), upper extremity exercise capacity (the six minute peg board ring test), lower extremity exercise capacity (six minute walk test), muscle oxygenation ('moxy' monitor device), dyspnea (modified borg scale), peripheral muscle strength (hand-held dynamometer), arterial stiffness (arteriograph device), physical activity level (multi-sensor activity monitor) and static balance (balance system with computed) will evaluated in children with pah and healthy controls. all assessments will be completed in two days.

Eligibility criteria:
inclusion criteria: patients: * between the ages of 6-18 * diagnosed with pulmonary arterial hypertension * stability of clinical condition and receiving standard medical treatment healthy controls: * between the ages of 6-18 * willing to participate in the study exclusion criteria: patients: * having any acute infection, orthopedic, neurological, cooperation, vision or hearing problems that may prevent during the measurements * participated in a planned exercise program in a last three months healthy controls: * having any acute or chronic illness * active or ex-smoker

Keywords: upper extremity exercise capacity muscle oxygenation arterial stiffness respiratory muscle strength
tunisian national registry on psoriasis

Conditions: Psoriasis

Summary: national cross-sectional multicentric study to describe the epidemiological characteristics of patients with psoriasis in tunisia

psotreg is a tunisian, descriptive, non-interventional, multicenter and cross-sectional clinical study performed in dermatology departments and outpatients clinics, of both public and private sectors. the study will enroll hospitalized and ambulatory patients with psoriasis disease, by successive inclusions until the end of the recruitment period, set at six months. a scientific committee validates the scientific writing, a steering committee supervises the clinical operations of the project. collected data are managed by the dacima clinical suite®, the electronic data capture platform which complies with the fda 21 cfr part 11 requirements (food and drug administration 21 code of federal regulations part 11), the hipaa specifications (health insurance portability and accountability act), and the ich standards (international conference on harmonisation). a local authorization by the national agency of personal data protection will be obtained prior to study kick-off.

Eligibility criteria:
inclusion criteria: * patients with psoriasis * informed and written consent exclusion criteria: * any dermatology disease other than psoriasis

Keywords: psoriasis dermatology tunisia dacima
the outreach and prevention at alcohol venues in east africa study (opal-east africa- aim 2) (opal-aim 2)

Conditions: HIV/AIDS

Summary: this study will evaluate the effect of a brief alcohol counseling intervention on prep and pep adherence among adults with heavy alcohol use at high risk for hiv, while gaining insights into the facilitators, barriers, and cost-effectiveness of this approach.

the investigators have developed a mobilization strategy of integrating hiv testing within multi-disease screening to recruit \>2,000 people from drinking venues in kenya and uganda and invite them to begin biomedical hiv prevention if eligible (opal aim 1; nct05862857) following uptake of biomedical hiv prevention, persons with heavy alcohol use face challenges with retention in care and adherence to prep/pep. the investigators have adapted a brief alcohol counseling intervention (health living intervention) to reduce alcohol use and promote antiretroviral therapy (art) adherence and hiv viral suppression among persons with hiv in kenya and uganda. the investigators now need to determine whether this intervention can promote retention in biomedical prevention and prep/pep adherence among adults with heavy alcohol use. specific aims: * determine the efficacy of the healthy living intervention (hli) to reduce heavy alcohol use vs. standard care (control) on retention in biomedical hiv prevention in a randomized trial among adults with heavy alcohol use. * determine the cost-effectiveness of interventions that increase biomedical hiv prevention retention among adults at high-risk for hiv who attend drinking venues. the proposed research will address the critical intersection of alcohol use and hiv risk in ssa, by promoting retention of biomedical hiv prevention and exploring associated facilitators and barriers.

Eligibility criteria:
inclusion criteria: * adult (≥18 years) * hiv-uninfected (by rapid hiv antibody test) * audit-c score of \>=4 for men and \>=3 for women * attending a clinical visit for initiation of biomedical hiv prevention with oral or injectable prep or oral pep (or the dapivirine vaginal ring, if available) * has access to a mobile phone exclusion criteria: * ineligible for prep based on moh guidelines * intention to move away from the study community in the coming year * gross inebriation or inability to provide informed consent

Keywords: alcohol use biomedical hiv prevention uganda kenya counseling intervention
the level of knowledge and awareness of myofascial pain syndrome in the turkish population

Conditions: Myofascial Pain Syndrome

Summary: this study aimed to assess the level of knowledge and awareness of myofascial pain syndrome (mps) among the turkish population.

the study will employ a cross-sectional design to assess the level of knowledge and awareness of myofascial pain syndrome (mps) in the turkish population. a representative sample of individuals will be selected for participation in the survey. a structured questionnaire will be developed specifically for this study, consisting of questions related to the understanding, recognition, and management of mps. the questionnaire will be administered through face-to-face interviews. data collected from the survey will be analyzed using appropriate statistical methods to determine the overall level of knowledge and awareness of mps among the turkish population.

Eligibility criteria:
inclusion criteria: * giving consent. exclusion criteria: * not giving consent. * any illness or disability that can prevent filling out the form or communicating.
effects of monosodium glutamate on energy balance and eating behavior

Conditions: Obesity; Weight Gain; Food Preferences

Summary: this study will test whether regular consumption of monosodium glutamate (msg) immediately prior to each of the three major meals (breakfast, lunch, dinner) inhibits body weight and fat regain following a period of moderate, yet clinically significant weight loss.

the proposed study enables us to assess the long term effects of consuming msg on body weight regain following weight loss.

Eligibility criteria:
inclusion criteria: * women * age 19-45 * bmi 27-35 * blood pressure \<140/90 * non-smoking exclusion criteria: * anemic: hgb \< 11.5 mg/dl * sensitivity to msg (self reported) * pregnant or planning to get pregnant * taking medication for hypertension, depression, or weight loss * diabetic * vegetarian * mri contraindications: internal metal, braces on teeth, history of metal in the eye, claustrophobia * blindness or heavily corrected vision * not fluent in english

Keywords: obesity food preferences eating behavior
the effect of ciprofol on breathing patterns, respiratory drive, and inspiratory effort in mechanically ventilated patients

Conditions: Mechanical Ventilation; Sedation and Analgesia

Summary: sedatives and analgesics are usually given for analgesic, anxiolytic, or sedating purposes for patients with critical illness, while they inevitably inhibit respiratory and circulatory function. sometimes, patients receive deep sedation to induce hypoventilation or suppress spontaneous respiratory effort. the sedation level in clinical practice is usually assessed with subjective sedation scoring systems, such as the richmond agitation sedation scale (rass). however, studies have found that sedation depth based on rass is not a reliable marker of respiratory drive during critical illness. in recent years, researchers have proposed to monitor the effects of sedatives and analgesics on respiratory indicators and to implement lung-protective sedation, such as p0.1, pocc, pmus, wob, and ptp. however, different pharmacological characteristics, different depths of sedation, and different sedation regimens among different sedatives and analgesics make a great difference in their effects on respiration. ciprofol is an analog of propofol, with increased stereoselective effects adding to its anesthetic properties, is increasingly used in the intensive care unit, but its effects on respiration are not well understood. therefore, this study aims to investigate the effects of ciprofol on respiratory patterns, respiratory drive, and inspiratory effort in mechanically ventilated patients.


Eligibility criteria:
inclusion criteria: * the patient received surgery under general anesthesia and admitted into the icu * the patient has been intubated and is receiving invasively mechanically ventilated with the mode of pressure support (psv) or continuous positive airway pressure (cpap) * the patient requires sedative medication targeting rass -2 to +1 for comfort, safety and to facilitate the delivery of life support measures exclusion criteria: * age \< 18 years * body mass index (bmi) \ 30 kg/m2 * pregnancy or lactation * brain stem tumors, myasthenia gravis, or neuromuscular diseases * acute severe neurological disorder and any other condition interfering with rass assessment * systolic blood pressure \< 90 mmhg after appropriate intravenous volume replacement and continuous infusions of 2 vasopressors * heart rate \< 50 beats per minute or second- or third-degree heart block in the absence of a pacemaker * contraindicate or allergic to any of the study medications * acute hepatitis or serious hepatic dysfunction (child-pugh class c) * chronic kidney disease with glomerular filtration rate (gfr) \< 60 ml/min/1.73m2 * alcohol abuse

Keywords: sedation analgesia mechanical ventilation respiratory patterns respiratory drive inspiratory effort
dexmedetomidine and the inflammatory response in pediatric cardiac surgery

Conditions: Cardiac Surgical Procedures

Summary: cardiopulmonary bypass-assisted surgery initiates a systemic inflammatory response induced by extrinsic (e.g. anesthesia, contact activation within the extracorporeal circuit, endotoxemia) and intrinsic (e.g. tissue damage, endothelial cell activation, ischemia-reperfusion injury of myocardium) factors. this may either be mild or lead to a more severe clinical condition. inflammation after pediatric open heart surgery is a parameter affecting also duration of mechanical ventilatory support. dexmedetomidine use was associated with a reduced increase in plasma il-1, il-6, tnf-a, and inf-g levels

dexmedetomidine will be used during cardiopulmonary bypass-assisted surgery for pediatric cardiac surgery

Eligibility criteria:
inclusion elective repair of congenital heart disease with cardiopulmonary bypass exclusion reintervention surgery requirement for blood products from the start of cpb, preoperative intake of corticosteroids, deep hypothermia, those with preoperative low cardiac output, those with non-palpable peripheral pulses before surgery (e.g., accompanying coarctation of the aorta) or ischemic time during cardiopulmonary bypass more than 90 minutes

Keywords: dexmedetomidine congenital heart disease cardiopulmonary bypass interleukin