Kornimate/medical-research-clean huggingface dataset:
light trial: levothyroxine for gestational hypothyroidism in recurrent pregnancy loss

Conditions: Abortion, Habitual

Summary: the goal of this randomized, double-blind, placebo-controlled clinical trial is to evaluate whether levothyroxine supplement improves pregnancy outcomes in women with recurrent pregnancy loss (rpl) and isolated maternal hypothyroidism (imh). the main questions it aims to answer are: does levothyroxine increase the live birth rate after 24 weeks of gestation? does levothyroxine improve secondary outcomes such as ongoing pregnancy rates, reduce the incidence of pregnancy loss, or influence maternal and neonatal complications? researchers will: compare the levothyroxine treatment group (50 µg/day) to the placebo group to assess the impact of the intervention on live birth rates and other pregnancy outcomes. participants will: be randomly assigned to receive either levothyroxine or a placebo. take the assigned treatment daily starting from enrollment until the end of pregnancy. undergo routine follow-up visits to monitor pregnancy progress and outcomes. this trial seeks to determine whether routine levothyroxine supplementation can improve pregnancy outcomes for women with rpl and imh.

investigators will perform a multi-center, randomized, placebo, double-blind clinical trial of levothyroxine (lt4) in patients aged between 18 years and 40 yearls who are diagnosed with isolated hypothyroxemia (defined as lower ft4 level with normal tsh) and have a previous history of recurrent miscarriages (defined as two or more pregnancy loss). investigators will assess the effects of standard dose of 50ug/d levothyroxine therapy from the day after randomization to the day of delivery on the pregnancy outcomes, including live birth, neonatal complications, and adverse pregnancy outcomes, etc.

Eligibility criteria:
inclusion criteria: * women with singleton pregnancy * women with a history of recurrent pregnancy loss (defined as two or more pregnancy loss before 20wks) * women diagnosed with isolated maternal hypothyroidism (defined as isolated lower level of ft4 with normal tsh levels) in the current pregnancy before 20wks exclusion criteria: * patients with known thyroid disorders * patients with antiphospholipid syndrome or other autoimmune conditions * patients with contraindications to levothyroxine (e.g., acute cardiac arrest, acute pancreatitis, acute myocarditis) * patients attending other ongoing clinical trials or unwilling to participate.

Keywords: recurrent pregnancy loss isolated maternal hypothyroidism levothyroxine adverse pregnancy outcomes live birth neonatal complications
prospective outcomes after reconstruction and radiotherapy for breast cancer

Conditions: Breast; Radiotherapy; Aesthetics; Treatment Outcome; Surgical Reconstruction

Summary: this study examines the aesthetic outcomes of breast reconstruction after mastectomy for breast cancer in patients who require post-mastectomy radiation treatment. patients will undergo autologous tissue breast reconstruction either in immediate fashion, prior to radiation treatment, or in delayed fashion, after radiation treatment. both approaches are acceptable and are practiced clinically. this will be an observational prospective cohort study. the investigators hypothesize that immediate autologous reconstruction patients who undergo subsequent radiation therapy have equivalent aesthetic outcome when compared to those in whom reconstruction is delayed until after radiation, with the additional benefit of avoiding the psychological side effects of breast amputation.

neo-adjuvant or adjuvant chemo-radiation remains one of the pillars for breast cancer treatment. (1, 2) administration of radiation before or after autologous soft tissue reconstruction has being shown to alter the aesthetics of the new breast. (3-7) currently, the optimal timing for autologous breast reconstruction in patients who need postmastectomy radiotherapy remains in debate between surgeons. (8) various studies have tried to address this problem. however, most of them have been retrospective studies (3, 7, 9) and the prospective ones have not have enough patients, have mixed population of patients or the radiation protocols have not been normalized. (5, 6, 10) we hypothesize that immediate autologous reconstruction patients who undergo subsequent radiation therapy have equivalent aesthetic outcome when compared to those in whom reconstruction is delayed until after radiation, with the additional benefit of avoiding the psychological side effects of breast amputation.

Eligibility criteria:
inclusion criteria: * breast cancer requiring mastectomy and post-mastectomy radiation * desire for breast reconstruction after mastectomy exclusion criteria: * inflammatory breast cancer * age \< 18 years old * no desire for breast reconstruction * women without need for postmastectomy radiation

Keywords: breast radiotherapy esthetics treatment outcome reconstructive surgical procedures
comparison of telavancin and vancomycin for complicated skin and skin structure infections with a focus on methicillin-resistant staphylococcus aureus

Conditions: Staphylococcal Skin Infection

Summary: study 0018 (nct00107978) compares the safety and effectiveness of an investigational drug, telavancin, and an approved drug, vancomycin, for the treatment of complicated skin and skin structure infections.


Eligibility criteria:
inclusion criteria: * patients must have a diagnosis of one of the following complicated skin and skin structure infections with mrsa (methicillin-resistant staphylococcus aureus) either suspected or confirmed as the major cause of the infection: * major abscess requiring surgical incision and drainage; * infected burn (see exclusion criteria for important qualifications); * deep/extensive cellulitis; * infected ulcer (see exclusion criteria for important qualifications); * wound infections * patients must be expected to require at least 7 days of intravenous antibiotic treatment. exclusion criteria: * received more than 24 hours of potentially effective systemic (iv/im or po) antibiotic therapy * burns involving \> 20% of body surface area or third degree/full thickness in nature, diabetic foot ulcers, ischemic ulcers/wounds, necrotizing fasciitis, gas gangrene, or mediastinitis.

Keywords: csssi (complicated skin and skin structure infections) staph (staphylococcus) mrsa (methicillin-resistant staphylococcus aureus)
the effect of synbiotics on the upper respiratory tract infection

Conditions: Upper Respiratory Tract Infection; Gut Microbiota; Immune Function

Summary: gut microbiome manipulation to alter the gut-lung axis may potentially protect humans against respiratory infections. however, clinical trials of synbiotics, one of the microbiota-targeted intervention, in this regard is few. therefore, this study aims to examine the effect of synbiotics on the incidence and severity of upper respiratory tract infection, gut microbiota composition and function, as well as biomarkers of immune function.


Eligibility criteria:
inclusion criteria: * aged 18-65 years； * good general health as determined by medical questionnaires; * bmi \<35 kg/m2; exclusion criteria: * known congenital or acquired immune defects； * allergies and other chronic or acute diseases requiring treatment； * subjects with chronic gastrointestinal diseases; * alcohol or drug misuse or both； * pregnancy or lactation； * vaccination against influenza within the last 12 months； * use of oral antibiotics, probiotics, prebiotics, synbiotics, drugs active on gastrointestinal motility, or a laxative of any class within the last month.
retrospective follow-up study after periacetabular osteotomy in adults

Conditions: Congenital Deformity of Hip Joints

Summary: this is a retrospective study assessing pre- and postoperative radiographic indices of hip dysplasia in order to identify factors predicting failure following periacetabular osteotomy (pao).

even though the pao is applied worldwide and is the preferred joint preserving treatment some issues remains unclear and controversial. one is the exact indication for surgery and risk factors for early failure of the procedure. the is a retrospective cohort study assessing pre- and postoperative radiographic indices of hip dysplasia in order to identify factors predicting failure following pao. the minimum duration of follow-up is 2 years. failure following pao is defined by a womac pain score \> 10 or the insertion of a total hip arthroplasty.

Eligibility criteria:
inclusion criteria: * pao from 1999-2007
relation between pregnenolone endocannabinoids in normal-weight and obese men

Conditions: Obesity

Summary: measured plasmatic concentration of pregnenolone and endocannabinoid in fasting conditions and over a meal in obese and normal-weight men subjects, to research a dysfunction in the negative feed-back between pregnenolone and cb1 ligand in obese subjects. this dysfunction could participate to the hyperactivity of endocannabinoid system saw in obesity.

endocannabinoid system is an orexigenic key system, controlling the energy balance. it is composed of receptors (ex: cb1), of endogenous ligands, the endocannabinoids (ex: anandamide and 2- arachidonoylglycerol) and of enzymes implied in the synthesis and the degradation of the endocannabinoids. researches resulting from our group highlighted anomalies of the plasmatic concentrations of endocannabinoid, in obese subject compared to normal-weight subject. those being higher in obese subject with a flatness of post prandial reduction of aea, so maintenance of elevated levels which can facilitate the food catch and create a metabolic vicious circle. in addition, prestigious research resulting from our collaborators highlighted in the animal that exposure to tetrahydrocannabinol (thc, ligand exogenic of cb1) induced the synthesis of pregnenolone (neurosteroid) which, by an autocrine effect on the cb1, inhibited the effects of the thc. in particular one of the principal behavioural effects: the food intake. we want to measure pregnenolone and endocannabinoid concentrations in men blood samples, to observe if this association exists in fasting conditions and over a meal in normal-weight and obese subjects. obese subjects will be recruited during an hospitalization, while normal subject will be recruited by a poster at bordeaux university and haut-leveque hospital. they will be included at haut-leveque hospital during morning at hospital.

Eligibility criteria:
inclusion criteria: * obese subjects: * men, * aged between 18 and 65 years, * bmi\>30kg/m2. * normal-weight subjects: * men, * aged between 18 and 65 years, * bmi\<25kg/m2. exclusion criteria: * for all subjects: * cannabis detected by urinary tetrahydrocannabinol presence, * treatment which can interfere with endocannabinoid system (antidepressant, antipsychotics, anxiolytics).

Keywords: pregnenolone endocannabinoid food intake type-1 cannabinoid receptor
influence of conditional workout postpartum on arterial stiffness among women with status after preeclampsia, superimposed preeclampsia or hellp-syndrome

Conditions: Preeclampsia; Superimposed Preeclampsia; HELLP Syndrome

Summary: evaluation of practicability in survey and test procedures and of successful implementation of complex interventions - feasibility analysis based on a pilot study: influence of conditional workout postpartum on arterial stiffness among women with status after preeclampsia, superimposed preeclampsia or hellp-syndrome

cardiovascular disease is the main cause of death among women in europe and in the usa. its costs amount annually more than 196 billions euro in europe. the federal state of saxony-anhalt occupies leading position in mortality in myocardial infarction and coronary heart disease in germany. up to 8 percent of all pregnant women develop a severe pregnancy-associated hypertension, like preeclampsia, superimposed preeclampsia or hellp-syndrome. these women have an increased lifetime risk for cardio- and cerebrovascular diseases. the consecutive increasing arterial stiffness because of endothelial dysfunction is a determining factor in etiology of pregnancy-associated hypertension and results in increased cardiovascular risk. aortal pulse wave velocity is used as goldstandard for measuring arterial stiffness. pregnant women suffering from a severe pregnancy-associated hypertension present higher levels in arterial stiffness measured by pulse wave velocity than healthy pregnant women. pathological changes of the vascular systems persistent from 6 month until 10 years after delivery and give an explanatory approach for an increased cardiovascular longterm risk at these patients. numerous medical associations like american heart association aim at reducing especially cardiovascular longterm risk in women with status after preeclampsia, superimposed preeclampsia or hellp syndrome. pregnancy-independent studies in patients with coronary heart disease and analysis in women with metabolic syndrome show a reduction of arterial stiffness by regular conditional workout. scientific problem of this pilot study: if a reduction in arterial stiffness in women from a risk group - during a 6-month-ongoing intensive regular conditional workout within a midwife-supported teamwork and under inclusion of dietary interventions - achieved?

Eligibility criteria:
inclusion criteria: * diagnosis of preeclampsia, superimposed gestosis or hellp syndrome * capacity for content exclusion criteria: * eclamptic stroke * new york heart association \> stadium ii * severe neurological or orthopedic disabilities * peripheral arterial occlusive disease * severe disease of the newborn which leads to an intensive familial care

Keywords: arterial stiffness preeclampsia hellp-syndrome pulse wave velocity advanced glycation endproducts skin autofluorescence conditional workout postpartum cardiovascular risk pregnancy vicorder age reader
a phase ii study to assess acute toxicity and quality of life of patients with carcinoma of the anal canal receiving chemotherapy and radiation using helical tomotherapy

Conditions: Anal Canal Cancer

Summary: the hypothesis is that helical tomotherapy could minimize radiation related toxicity by avoiding or limiting doses to structures such as small bowel, external genitalia, skin, bladder, rectum, and femoral neck and head.

this is a phase ii study using tomotherapy for radiation treatment delivery along with concurrent 5-fu/mitomycin c for the treatment of t2-t4 cancer of the anal canal. they hypothesis is that helical tomotherapy could minimize radiation related toxicity by avoiding or limiting doses to structures such as small bowel, external genitalia, skin, bladder, rectum, and femoral neck and head. this is expected to limit or reduce treatment related toxicity and hence prevent or reduce treatment breaks. this may result in delivery of radical treatment with better local control and treatment outcome than using the current radiation treatment technique at our center.

Eligibility criteria:
inclusion criteria: * patient should have histologically proven primary squamous carcinoma or its variant * no history of prior malignancy. * patients must be free of metastatic disease out of pelvis at the time of diagnosis * patients must be at least 18 years of age * performance status 0, 1 or 2 ecog * t stage 2-4, any n, stage mo * patient should be eligible for concomitant chemotherapy * informed written consent required to participate exclusion criteria: * prior radiation to pelvis * pregnant or lactating * prior surgical treatment for anal cancer other than biopsy * prior surgical or chemotherapy treatment for anal cancer * t1 tumours (2cm) or evidence of distant mets * comorbid medical conditions precluding radical treatment at the discretion of oncologist

Keywords: tomotherapy
relationship between bispectral index (bis) and spectral entropy (spen) during desflurane anaesthesia

Conditions: Intraoperative Awareness

Summary: the aim of this study was to estimate the relationship between bis and spectral entropy values and any explicit or implicit memory or dreams recall during desflurane anaesthesia.

during the last decade, an increasing number of monitor systems were developed designed to assess the depth of anesthesia. awareness is a rare occurrence of explicit recalls during anaesthesia with an incidence of 0,18% and the use of cerebral monitoring prevents about 50% of these events. different stages of awareness should be defined and implicit memorization is subconscious awareness without explicit recall and possible implicit recall with an incidence greater than awareness. to assess implicit recalls, a large number of test can be used, for example the "word stem completation test" and the "free recall association test". these result easy to use and reliable in detect implicit memory. bispectral index (bis) and spectral entropy (spen) has been proposed, in recent years, as electroencephalographic monitors of anaesthesia depth. the bispectral index is a monitor of anaesthetic depth approved by the food and drug administration in the usa. the bis monitor reports a dimensionless number between 0 (complete eeg inactivity) and 100 (awake state); bis values from 40 to 60 are thought to be suitable for general anaesthesia. spectral entropy acquires the electroencephalograph (eeg) and frontal electromyography (femg) signals which are processed into three parameters: state entropy (se), response entropy (re) and burst suppression ratio (bsr). se is computed over the eeg dominant part of the spectrum (0.8-32 hz), and therefore primarily should reflect the cortical state of the patient and results useful to assess hypnotic effects of drugs . re is computed over a frequency range from 0.8 to47 hz. it includes both the eeg-dominant and emg-dominant part of the spectrum . the se and re values below 60 correlate with a low probability of consciousness. also bispectral index provides brs, an evaluation of burst suppression in which cerebral activity results suppressed. bis and spectral entropy are intended to decrease the risk of intraoperative awareness and to enable the anesthetist to reduce risk of the under- and overdosing of anesthetic agents and to ensure faster and more predictable wake-up and extubation. previous studies result contrasting in the correlation between these devices with lack in evaluation of implicit memory. the aim of this study was to estimate the relationship between bis and spectral entropy values and any explicit or implicit memory or dreams recall during desflurane anaesthesia.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologist physical status i-ii * italian native speakers exclusion criteria: * psychiatric or neurologic diseases * acoustic impairment * obesity (body mass index \> 30) * substance dependence.

Keywords: awareness
active surveillance research program for the assessment of the safety and the effectiveness of linagliptin

Conditions: Diabetes Mellitus, Type 2

Summary: this protocol is for a series of comparative effectiveness and safety analyses within periodically updated cohorts of patients initiating linagliptin, other dpp-4 inhibitors, and other oral hypoglycemic medications, followed longitudinally for the occurrence of a variety of health outcomes. the primary analysis will be conducted among patients without prior within-class medication use.


Eligibility criteria:
inclusion criteria: * a dispensing of an oral hypoglycemic medication * a diagnosis of type 2 diabetes mellitus (t2dm) exclusion criteria: * less than 18 years old * missing or ambiguous age or sex information * at least one diagnosis of type 1 diabetes mellitus * less than 6 months enrolment in the database preceding the date of the first dispensing * secondary diabetes * history of cancer * end-stage renal disease (esrd) * hiv * organ transplant
improvement in endothelial dysfunction after initiation of anti-arrhythmic therapy in atrial fibrillation patients

Conditions: Atrial Fibrillation

Summary: this is a prospective, observational study that will examine endothelial dysfunction in atrial fibrillation before and after treatment with anti-arrhythmic agents and the extent to which baseline endothelial dysfunction improves after treatment.

this will be a prospective, observational study and roughly 60 patients will be recruited based on strict inclusion/exclusion criteria. goal population includes adult patients with a diagnosis of paroxysmal or persistent atrial fibrillation seen in the electrophysiology clinic and admitted to the upmc presbyterian electrophysiology service for initiation of anti-arrhythmic medications. the primary goal of the study will be to evaluate the degree of endothelial function recovery seen after initiating anti-arrhythmic medical therapy. we will assess genetic markers, arterial stiffness and vasodilation in response to acetylcholine iontophoresis, nitroprusside iontophoresis, local thermal hyperemia and reactive hyperemia. laser speckle contrast imaging will be employed to evaluate the microvasculature. sphygmocor (arterial tonometry) will be used to assess macrovasculature. testing will be performed at baseline prior to the 1st dose of anti- arrhythmic therapy and repeated again 1-3 months later at outpatient follow-up visit. additionally, follow-up phone calls or office visits will take place at 6 and 12 months after the initial data collection visit to document recurrence rate of atrial fibrillation.

Eligibility criteria:
inclusion criteria: * adult patients (18-75 years of age) with paroxysmal or persistent atrial fibrillation * patients who recovered from prior tachycardia induced cardiomyopathy will be allowed to enroll in the study. exclusion criteria: exclusion criteria will include: * age \>75 years * history of cardiomyopathy * history of severe cardiac valvular disease * history of coronary artery disease * pulmonary artery hypertension * congenital heart disease * history of stroke * chronic hypoxia * recent worsening or flare up of obstructive or restrictive lung disease * liver cirrhosis * stage three or worse chronic kidney disease * any major trauma or surgery within the preceding 3 months * uncontrolled hyperthyroidism * uncontrolled hypertension * uncontrolled diabetes mellitus * active malignancy * poorly controlled connective tissue disease * any acute or chronic inflammatory or infectious disease * patients who are already on class i or class iii antiarrhythmic agents will be excluded from the study * patients on non-dihydropyridine calcium channel blockers and beta blockers will not be excluded from the study, as these agents are not considered anti-arrhythmics and are not hypothesized to affect endothelial function.
a retrospective review of dextenza 0.4 mg insert following corneal transplant or cataract surgery

Conditions: Anterior Chamber Inflammation; Ocular Pain; Corneal Edema; Corneal Defect; Penetrating KeratoPlasty; Nuclear Cataract; Cortical Cataract; Cataract Senile

Summary: a retrospective review of pain and inflammation resolution outcomes in patients who received dextenza intracanalicular dexamethasone (0.4 mg) insert prior to or following corneal transplant or cataract surgery

a retrospective review of pain and inflammation resolution outcomes in patients who received dextenza intracanalicular dexamethasone (0.4 mg) insert, placed within the lower or upper eye lid canaliculus in conjunction with topical steroid prior to or following corneal transplant or cataract surgery

Eligibility criteria:
inclusion criteria: * age 18 years and older * patients who received dextenza insertion perioperatively. exclusion criteria: * any patient who did not receive dextenza insertion