Kornimate/medical-research-clean huggingface dataset:
mediterranean diet and the gut microbiome

Conditions: Irritable Bowel Syndrome

Summary: this study will evaluate the impact of a mediterranean-style diet on microbiome diversity compared to a typical american diet. the study will observe the microbiome composition comparisons in healthy volunteers as well as in patients with irritable bowel syndrome with diarrhea (ibs-d) to see if the consumption of a mediterranean-style diet has a positive effect on improving symptoms of ibs-d.

irritable bowel syndrome (ibs) is the most prevalent and well-studied functional gastrointestinal disorder. while ibs has no direct mortality, it does compromise quality of life, incurs morbidity, and has a substantial economic impact on society. the gut microbiome may play a significant role in the pathogenesis of ibs. even though the exact mechanisms underlying this relationship have not been presented, it is suggested that certain microorganisms may increase gut permeability, activate the mucosal immune response, increase visceral sensitivity and alter intestinal motility via a bidirectional brain-gut interaction. recent studies suggest that the salutary impact of the mediterranean diet may be due to its effects on the composition of the gut microbiome. in a recent cohort study in italy, subjects who adhered most closely to a classical mediterranean diet had more favorable bacterial enterotypes (e.g., prevotella) in their stool, as well as higher levels of short-chain fatty acids - which are essential for colonic function. studies have also showed that diet alters the predominant microbiome enterotypes and that microbiome composition can change quickly, within 24 hours, after a dietary intervention. therefore, consumption of a mediterranean diet may ameliorate the gut dysbiosis associated with ibs-d.

Eligibility criteria:
inclusion criteria: * must be willing to eat pre-prepared foods for 4 weeks * subjects must have no medical, religious, or cultural dietary restrictions that would preclude their eating a mediterranean diet. * phase 2 subjects- must have diagnosis of ibs based on rome iii criteria and have diarrhea-predominant disease, defined as \>50% of bowel movements characterized as diarrhea exclusion criteria: * history of gastrointestinal disease, including celiac disease, inflammatory bowel disease, or lactose intolerance * diabetes mellitus * congestive heart failure * coronary artery disease * chronic liver disease or end stage renal disease * pregnancy or breastfeeding * trainees under the direct supervision of the pi and patients receiving direct ongoing medical care from the pi or co-i will not be enrolled as subjects in this study

Keywords: mediterranean diet gut microbiome gastrointestinal
an analysis of adverse events and satisfaction outcomes of women who underwent primary and secondary breast augmentation using silimed® breast implants

Conditions: Breast Implant; Complications; Quality of Life; Satisfaction

Summary: the study investigates the safety and performance of silimed® silicone gel breast implants with a textured surface and silimed® silicone gel breast implants with polyurethane coated surface. female patients who underwent primary or secondary breast augmentation using silimed® breast implants will be followed-up through 10 years. the safety of each type of silimed® breast implant is going to be assessed by estimating the known and unexpected short- and long-term risk / adverse event rates. the performance of each type of silimed® breast implant is going to be assesses by estimating the satisfaction and quality of life after implantation.


Eligibility criteria:
inclusion criteria: * provide written informed consent. * female at birth * be 18 years of age or older * have received breast implant(s) for indication of primary or secondary augmentation until 21 days before (including the visit window) * having received a breast implant with a textured surface or a breast implant with a surface coated with silimed® polyurethane foam * ability to comply with the protocol throughout the follow-up period. exclusion criteria: * mammary reconstruction in at least one breast or augmentation after previous reconstruction, * pregnancy informed or breastfeeding at the inclusion moment, * advanced fibrocystic disease at the time of implantation, * neoplasia of any type not yet treated or being treated at the time of implantation, infection in activity not yet treated or being treated at any site at the time of implantation, * reporting or recording of adverse reactions or intolerance to polyurethane or silicone prior to implantation, * immune diseases affecting active connective tissue or (eg, lupus erythematosus, discoid lupus, scleroderma, etc.) at the time of implantation, * signs of inflammation of the breast or implant site at the time of implantation, * increased risk of immediate postoperative complications due to use of illicit drugs or medications, * increased risk of immediate post-surgical complications caused by illicit drug use or medication use, * have participated in another clinical study up to 6 months prior to the placement of the implant, * any other condition which, based on the opinion of the investigator or designee, may prevent the provision of informed consent, renders participation in the study is unsafe, compromises adherence to the protocol, complicates the interpretation of data from the study outcome, or otherwise interferes with the achievement of study objectives.

Keywords: breast implant complication satisfaction quality of life augmentation textured polyurethane
neuropathic pain management

Conditions: Diabetic Neuropathies; Polyneuropathies

Summary: this is a prospective, randomized, double blind, comparative, experimental controlled phase 3 clinical trial to assess the efficacy, safety and superiority of f0343 (gabapentin combined with b vitamins) compared to gabapentin alone for treating neuropathic pain in subjects with chronic distal diabetic polyneuropathy.

subjects will be assigned to one of the two arms of the study, after having been deemed eligible during the screening visit in random double-blind design. subjects will be evaluated for a 4 week period. objectives * to assess the effects of f0434 and gabapentin alone on neuropathic pain and quality of life (qol) of subjects with diabetic neuropathy through a current and validated neuropathic pain scale along with the qol questionnaire.

Eligibility criteria:
inclusion criteria: * subjects diagnosed with diabetes mellitus type 2 * subjects with a history of neuropathic pain in the last 3 months * men and women in reproductive age with a family planning method * subjects aged between 18 to 70 years * subjects with glycosylated haemoglobin (hba1c) greater than 7% and less than 15% * subjects that obtain a grade equal or greater than 4 in the visual analogue scale during the screening visit exclusion criteria: * subjects diagnosed as being pregnant or in state of lactation * subjects with serum creatinine greater than 1.2 or creatinine depuration in 24 hour urine, less than 60ml/min * subjects who are receiving treatment with anti-depressants, anti-epileptics, and are taking vitamin b1 and b12 for treatment of neuropathic diabetes * subjects who are being pharmacologically treated for epilepsy * subjects diagnosed with rheumatic and hepatic disease and diagnosed with neuropathy for other causes * subjects with psychological and psychiatric alteration that hinders adequate collaboration in the study * subjects with any orthopaedic alteration of any extremity * subjects with peripheral artery disease * subjects taking more than two neuropathic pain medicines * subjects with history of alcohol, cocaine, marijuana or benzodiazepine substance abuse * subjects with acid-peptic disease * subjects with history of neoplasm of any type

Keywords: polyneuropathy diabetes mellitus diabetic peripheral neuropathy
effect of pulsed electromagnetic field and pulsed ultrasound in treating knee osteoarthritis

Conditions: Osteo Arthritis Knee; Ultrasound Therapy; Complications

Summary: this study will be carried out to combine the effect of pemf and put on pain, function, and rom in patients with knee oa.

osteoarthritis (oa) is one of the most frequent illnesses in the world, affecting the knee joint in particular. osteoarthritis of the knee is the most common cause of physical limitations and a decline in quality of life. oa of the knee affects 250 million individuals worldwide (3.6 percent of the population). according to the world health organization's study on the global burden of illness, knee oa is expected to become the eighth-most ultrasound is one of the most often utilized and misunderstood treatment techniques. ultrasound can help in the treatment or rehabilitation of musculoskeletal problems when utilized appropriately. when it is administered wrongly, however, the therapy provides little benefit at best, and at worst, the desired physiological effects are restricted or hindered. electrotherapy is frequently used for the treatment of different musculoskeletal disorders, the most common types of electrotherapy are ultrasound (us), iontophoresis, laser therapy, electromagnetic therapy, and transcutaneous electrical nerve stimulation (tens). to our knowledge, no previous clinical trials have combined the effectiveness of pemf and pust in the treatment of knee oa. therefore, this study will be conducted to combine the efficacy of pemf and pust in the treatment of knee osteoarthritis.

Eligibility criteria:
inclusion criteria: 1. subjects diagnosed with moderate unilateral knee oa according to the american college of rheumatology criteria * morning stiffness * crepitus on knee motion * bony tenderness * no palpable warmth. 2. a population of individuals (45-55 years old). 3. patients are not obese their body mass index (bmi) will be\> 30kg/ m2. 4. with a diagnosis grade 2 radiographic severity according to the kellgren/lawrence scale. grading scale the severity of the disease was radiologically evaluated by an orthopedic knee specialist. exclusion criteria: patients with the following criteria will be excluded from participating in this study: 1. if they had received an intra-articular injection of hyaluronic acid or corticoids during the six months prior to the study. 2. if they had a clinical history of orthopedic knee surgery, a skin disorder. 3. cardiovascular diseases, such as acute myocardial infarction, during the previous month, or uncontrolled arterial hypertension, acute-phase respiratory conditions. 4. or if they had been receiving another kind of physiotherapeutic treatment.
skin denervation in systemic lupus erythematosus

Conditions: Systemic Lupus Erythematosus

Summary: to address the issues of skin denervation and its clinical and pathological correlations in systemic lupus erythematosus

to address the issues of skin denervation and its clinical and pathological correlations in lupus, we will study a systemic lupus erythematosus (sle) cohort by evaluating the extent of cutaneous innervation. patients are recruited from the rheumatologic clinic, and various neuropsychiatric syndromes are diagnosed based on clinical judgement following detailed history taking and neurological examinations. skin biopsy with pgp 9.5 immunohistochemistry will be performed following established procedures after informed consent is obtained, and punches of 3 mm in diameter will be taken from the lateral side of the distal leg, 10 cm above the lateral malleolus. intraepidermal nerve fibre densities will be compared with results of immunological, pathological, psychophysical, and electrophysical studies to understand the pathogenesis of peripheral neuropathy in sle.

Eligibility criteria:
inclusion criteria: * diagnosis of systemic lupus erythematosus based on the consensus criteria exclusion criteria: * conditions known to be associated with peripheral neuropathy, such as diabetes, uremia, alcoholism, and the administration of potentially neurotoxic agents, such as alkylating agents, methotrexate, cyclosporine, and antibiotics.

Keywords: peripheral neuropathy;systemic lupus erythematosus
the effects of general anesthesia on microcirculation of central and peripheral soft tissue: a comparison of inhalational and intravenous anesthetics

Conditions: Microcirculatory Effects of Anesthesia; Inhalation and Intravenous Anesthesia

Summary: effects of different general anesthetics on peripheral microcirculation.

human keep body temperature in a narrow range by a variety of regulatory mechanism. peripheral thermal receptors send signals to central nervous system which regulate body temperature via peripheral effectors, such as vasoconstriction, vasodilatation, shivering, sweating and etc. in patients undergoing general anesthesia, the regulatory mechanism is altered. general anesthesia changes blood distribution in the body, the metabolic rate of muscle, threshold of thermal regulation in the brain and etc, so that heat distribution and microcirculation condition will also change. in this study, near-infrared spectroscopy (nirs) is used to measure the microcirculatory condition. nirs is a non-invasive continuous measurement to detect tissue saturation with the method of different wavelength of near-infrared. general anesthesia with inhalational sevoflurane and intravenous propofol is separated into 2 groups. because of different mechanism of general anesthesia of these 2 anesthetics, different physiologic response may occur. body temperature and somatic saturation are compared in each group.

Eligibility criteria:
inclusion criteria: 1. breast surgeries under general anesthesia 2. bmi 18.5\~30 exclusion criteria: 1. cardiac disease 2. lung disease 3. renal disease 4. neurological disease 5. autonomic nervous system dysfunction

Keywords: microperfusion temperature near-infrared spectroscopy anesthesia total intravenous anaesthesia
sbrt for breast cancer oligometastases

Conditions: Breast Neoplasm Malignant Female

Summary: this is a prospective data collection of treatment outcome for newly diagnosed oligometastatic breast cancers with 1-3 bone metastases. eligible patients will be identified from the weekly breast mdc. patients will receive the recommended systemic and local treatment (including metastases directed sbrt) according to our clinical practice guidelines.patients will be followed according to our routine with clinical and radiologic assessment. it is preferred that the same imaging method that was used to originally detect the metastases be used in follow-up assessments. the first imaging for sbrt sites will be three months post sbrt and every three months for the first year, every 6 months for the second year, then annually. response and progression for these metastases will be evaluated using the revised response evaluation criteria in solid tumors (recist) guideline (version 1.1). changes in the largest diameter (unidimensional measurement) of the tumor lesions is used in the recist criteria. if functional imaging (bone scan, pet) were used at staging, changes in the uptake will be used in follow up scans to determine response to treatment and progression. as for sbrt related morbidities, we will use the common terminology criteria for adverse events (ctcae v5) for toxicity reporting and scoring.


Eligibility criteria:
inclusion criteria: * women \>18 years old with a pathologically proven breast cancer who present with 1-3 bone metastases will be included. * metastases need to be confirmed pathologically if possible, otherwise two different imaging modalities (ctor mri and bone scan or pet) are needed to confirm metastases. * patients should be able to receive the recommended local and systemic treatment and the primary tumor must be controlled at time of sbrt. * maximum diameter of individual metastasis metastasis in any dimension ≤ 5 cm; and must be \>5 cm away from each other (defined as edge to edge of tumor). exclusion criteria: * non bone metastatic breast cancers * prior history of radiotherapy to same sites of sbrt * pathologic fractures of involved bones * contraindications to radiotherapy including pregnancy and connective tissue disease. * patients with impaired cognitive functions.

Keywords: stereotactic body radiotherapy
tourniquet reduces blood loss in postpartum hemorrhage during hysterectomy for placenta accreta

Conditions: Placenta Accreta; Post Partum Hemorrhage; Blood Loss Massive

Summary: monocentric prospective observational study comparing the use of tourniquet in low uterus segement versus standard procedure in hysterectomy owing to placenta accreta

it is a monocentric prospective observational case-control study in the department "c" of gynecology and obstetrics in the maternity and neonatology center of tunis during three years from october 2014 to september 2017. all parturient were informed about the possibility of performing a hysterectomy if accretization was clinically confirmed preoperatively. after obtaining written formal consent. all patients who underwent scheduled or emergency cesarean section for placenta accreta were included. either it was highly suspected or confirmed by obstetrical imaging. mri was always performed in cases of scheduled cesarean delivery. however, in cases of delayed transfer or if parturient was already in labor, only ultrasonography was done and considered as sufficient. delivery was usually scheduled at 36 weeks of gestation. patients were allocated into two group: group tg in which a tourniquet was systematically applied on the lower segment of the uterus during emergent hysterectomy, control group cg when the emergent caesarian hysterectomy was performed without a tourniquet. allocation depended on the technique and the decision of the surgeon in charge. after appropriate conditioning and monitoring, the cesarean section was performed under general anesthesia. the laparotomy was performed through a mid-line incision from the umbilicus to the pubic symphysis. hysterotomy was made far from the placental insertion which was previously located by ultrasonography. the accretization was clinically checked immediately after delivery but no attempt was made to manually remove the placenta. the umbilical cord was ligated to its insertion and the uterus was quickly sutured with the placenta kept in place. careful detachment of the bladder-uterus peritoneum was then carried out in order to lower the bladder and reduce the risk of bladder wounds. tourniquet application procedure is described as following 1. suturing hysterotomy with placenta kept in place. 2. after a cautious dissection a folley catheter is placed in the lower segment of the uterus as tourniquet. 3. complete hysterectomy

Eligibility criteria:
inclusion criteria: * . all patients undergoing scheduled or emergency cesarean section for placenta accreta exclusion criteria: * no signs of accretetization upon artificial delivery

Keywords: tourniquet low uterus segment placenta accreta hysterectomy massive blood loss management
solius uv light source in improving serum levels of 25-hydroxyvitamin d

Conditions: Vitamin D Deficiency; Vitamin D Insufficiency

Summary: this is a feasibility interventional study seeking to determine the safety and efficacy of the solius photobiologic system in increasing the serum levels of 25(oh)d in a vitamin d deficient/insufficient adult population.

the investigators will conduct an interventional study to determine the changes in the changes in serum 25-hydroxyvitamin d levels between subjects who receive weekly exposures to ultraviolet b radiation (uvb) generated by the solius photobiological system for 4 weeks. subjects will first undergo an evaluation of each individual's sensitivity to the solius photobiological system uvb using the device titration system for the first 5 weeks. once determined after the 5 weeks, the subjects will be enrolled in a 4-week study where they will be exposed to their individualized titration evaluation. approximately 14 adult participants will be enrolled for serum 25-hydroxyvitamin d screening. the investigators expect to enroll 10 vitamin d-deficient or insufficient subjects in this study. serum 25-hydroxyvitamin d levels will be measured prior to the first titration (week 2), prior to the intervention (week 6) and after the end of the study, and and the changes in serum 25-hydroxyvitamin d levels will be analyzed. the investigators expect that the levels will increase from the baseline.

Eligibility criteria:
inclusion criteria: 1. age at least 22 years old 2. male or female 3. skin type i-vi 4. women of childbearing potential must be on birth control and not pregnant based on a negative pregnancy test at baseline. 5. ability and willingness to give informed consent and comply to protocol requirements 6. serum total 25(oh)d \< 30 ng/ml exclusion criteria: 1. ongoing treatment with supplemental or pharmacological doses of vitamin d, vitamin d metabolites or analogues 2. pregnant 3. history of underlying photosensitivity 4. use of medications that cause a photosensitivity reaction (including but not limited to): tetracycline, tretinoin, amiodarone, doxycycline, naproxen, diphenhydramine, methotrexate, and hydrochlorothiazide 5. history of skin cancer 6. plan to received significant sun exposure below the 33rd parallel during study 7. used tanning or phototherapy devices within the last 30 days 8. vitamin d supplement use of more than 600 ius daily. 9. systemic steroids use 10. h1 antihistamine use in the last 7 days 11. diagnosed with light allergies (including but not limited to): actinic prurigo, polymorphous light eruption, or solar urticaria 12. diagnosed with light sensitivities (including but not limited to): protoporphyria, photodermatitis, xeroderma pigmentosum, lupus erythematosus, chronic actinic dermatitis, or uv-sensitive syndrome

Keywords: vitamin d ultraviolet b radiation
comparison of vascular function in emergency service professionals

Conditions: Vascular Function; Atherothrombosis

Summary: emergency service professionals have an increased risk of death from heart attacks when compared to the general public. all the emergency professions share similar responsibilities such as emergency call-outs and shift work. heart disease is the commonest cause of on-duty death amongst fire-fighters accounting for 45% and compared with 22% in police officers and 15% in the general population. the unique risk to fire-fighters is likely to reflect a combination of factors including extreme physical exertion, mental stress, heat and pollutant exposure. in this study the investigators will assess healthy career fire-fighters and age-matched healthy police officer control subjects following a sedentary period. the investigators will take blood samples to measure platelet activity (platelets are the particles in blood that help blood clot) and will examine how blood clots outside of the body. the investigators will then perform studies placing small needles in the arm to assess how the blood vessels respond following these duties. the investigators hypothesise that fire-fighters do not have pre-existing impairment of heart, blood or blood vessel function as a cumulative effect of their occupation, but rather these are acute and transitory effects following distinct fire-fighter duties. we therefore expect similar results in both occupational groups.


Eligibility criteria:
inclusion criteria: * non-smoking healthy firefighters exclusion criteria: * current smoker * history of lung or ischaemic heart disease * malignant arrhythmia * systolic blood pressure \>190mmhg or \<100mmhg * renal or hepatic dysfunction * previous history of blood dyscrasia * unable to tolerate the supine position * blood donation within the last 3 months * recent respiratory tract infection within the past 4 weeks * routine medication including aspirin and nsaids

Keywords: firefighters police officers emergency service professionals myocardial infarction endothelial function thrombosis