Kornimate/medical-research-clean huggingface dataset:
sinemet for spasticity and function in amyotrophic lateral sclerosis and primary lateral sclerosis

Conditions: Amyotrophic Lateral Sclerosis; Motor Neuron Disease

Summary: motivated by the success of dopaminergic drugs in treating rigidity associated with parkinson's disease, some neurologists have used carbidopa-levodopa (sinemet) to attempt to improve spasticity in als and pls patients. however, data on the efficacy of carbidopa/levodopa is limited. given the limited data and potential to improve the quality of life of these patients, the effectiveness of carbidopa-levodopa in als and pls patients with severe spasticity should be studied. the investigators hypothesis is that administration of carbidopa-levodopa will improve spasticity in als and pls patients.


Eligibility criteria:
inclusion criteria: * diagnosis of als or pls * age greater than 18 years * clinically significant spasticity. exclusion criteria: * individuals currently taking carbidopa-levodopa or with known hypersensitivity of any component of carbidopa-levodopa * narrow-angle glaucoma * current use of a non-selective monoamine oxidase inhibitor (maoi) * history of malignant melanoma or suspicious skin lesions * history of depression, suicidal ideation, or psychosis * history of myocardial infarction, ventricular arrhythmia, or severe cardiopulmonary disease * uncontrolled hypertension * asthma * renal disease * hepatic disease * endocrine disease * history of peptic ulcer * pregnant and/or breastfeeding * current participation in another interventional study

Keywords: als pls primary lateral sclerosis
acute and cronic evaluation of av/pv and vv delay iegm based optimisation algorithm-quicksept study

Conditions: Heart Failure

Summary: atrioventricular (av) and interventricular (vv) delay optimization can improve ventricular function in cardiac resynchronization therapy (crt) and is usually performed by means of echocardiography. st jude medical has developed an automated algorhythm which calculates the optimal av and vv delays (quickopttm) based on intracardiac electrograms, (iegm), within 2 minutes. so far, the efficacy of the algorhythm has been tested acutely with standard lead position at right ventricular (rv) apex. aim of this project is to evaluate the algorhythm performance in the mid- and long-term with rv lead located in mid-septum.

primary end-point was to evaluate the relationship between the series of aortic flow velocity time integral (avti) values calculated by the two methods at the pv, av, and vv interval settings recommended by both the quickopttm and the standard echo optimization in crt-d patients, at three index times: pre-discharge, at 6-month and at 12-month follow-ups. secondary end-point was to define the correlation between the optimal av, pv and vv intervals defined by echo, using avti measurements and by the quickopttm algorithm, iegm-based.

Eligibility criteria:
inclusion criteria: * patients with crt-d * stable and safe placement of an active-fixation rv lead on mid-interventricular septum; * achievement of an efficacious lv intravenous pacing from a coronary sinus (cs) branch. exclusion criteria: * af * patients without spontaneous rhythm
methotrexate treatment for ectopic pregnancy

Conditions: Ectopic Pregnancy

Summary: ectopic pregnancy is an important cause of maternal morbidity and occasionally mortality. deaths associated with ectopic pregnancy have declined, though approximately 75% of deaths in the first trimester and 9-13% of all pregnancy-related deaths are associated ectopic pregnancy. the main stays of management for ectopic pregnancy were surgery and medical treatment. medical management with systemic methotrexate administration avoids the inherent morbidity of anesthesia and surgery is cost-effective, and also offers success rates comparable to surgical management, with no loss in future potential fertility. however, although medical management using methotrexate is used commonly, there is no solid consensus regarding dose protocol. currently, there are three methotrexate protocols for the treatment of an ectopic pregnancy, "multi-dose", "single-dose", or "two-dose". among them, the multi-dose protocol includes the administration of 4 methotrexate doses alternating with leucovorin (rescue regimen). as a result of the multiple dosing of methotrexate, side effects are more common. in contrast, the advantages of the single-dose protocol include elimination of a rescue regimen, lower incidence of adverse effects, and better compliance. however, the single-dose protocol was found to be associated with a considerably lower success rate as compared with the multi-dose protocol (88% versus 93%) in a recent meta-analysis. the two-dose protocol, which it balances efficacy and safety/convenience, was described as a cross between the multi-dose and single-dose protocols. however, there were a few studies comparing between single-dose and two-dose protocol. the purpose of this prospective randomized trial was to compared the success rates of single-dose and two-dose methotrexate protocol for the treatment of tubal ectopic pregnancy.


Eligibility criteria:
inclusion criteria: * tubal pregnancy * tubal pregnancy except interstitial pregnancy * a pretreatment β-hcg level \<15000 miu/ml * a gestational sac with a largest diameter \<4 cm * hemodynamically stable status * agreement to methotrexate treatment and follow up exclusion criteria: * heterotrophic pregnancy * a presence of embryonic cardiac motion * clinically or sonographically suspected tubal rupture * laboratory tests showing possible deleterious effects of methotrexate treatment on organ functions
alveolar recruitment maneuver during cesarean section improves lung compliance

Conditions: Decreased Lung Compliance; Hypoxia; Hypercapnia; Atelectasis; Pneumonia

Summary: the investigators tested the hypothesis that alveolar recruitment maneuver during cesarean section and in women under general anesthesia improves lung compliance and gas exchange. the investigators applied recruitment maneuver and positive end expiratory pressure (peep) 8 cmh2o. the maximum alveolar pressure limit (ppeak)was 45 cmh2o during the recruitment maneuver. the primary end point of the study is the improvement of the lung compliance measured as volume difference/pressure difference (dv/dp) or ml/cmh2o

the investigators used recruitment maneuver during cesarean section and in women under general anesthesia. the primary end point of the study is the improvement of the lung compliance measured as volume difference/pressure difference (dv/dp) or ml/cmh2o after the recruitment maneuver. the investigators used 2 groups of patients. in the first group the investigators used pressure control ventilation for the recruitment maneuver. after the ventilator was switched to pressure control mode the investigators increased the inspiratory time to 50% and the inspiratory pressure above positive end expiratory pressure (ppeak) to 20 cmh2o. then the investigators progressively increased positive end expiratory pressure (peep) to have a peak inspiratory pressure (ppeak) to 45 cm h2o. the whole recruitment maneuver lasts 2 minutes. after the recruitment maneuver the investigators used volume control ventilation again (with the baseline settings)and peep step wised decreased to 8 cmh20but. peep (8cmh2o) was left until the end of the operation. in the second group the investigators did not used lung recruitment maneuver at all. in both groups lung compliance was measured (dynamic and static)as dv/dp (ml/cmh2o). measures were assessed 1 minute after delivery (but before recruitment), 3 minutes after recruitment (first group) at 10 and at 20 minutes after recruitment. the investigators also measured ppeak (cmh2o) and pplateau (cmh2o)inspiratory pressures , blood pressure (mmhg), beats per minute, oxygen saturation, end-tidal co2 according to the above time frame, blood gases before and 3 minutes after recruitment etc.

Eligibility criteria:
inclusion criteria: * general anesthesia, * hemodynamically stable exclusion criteria: * intracranial hypertension, * pulmonary hypertension, * low blood pressure (mbp\<80 mmhg), * heart rate \> 100 beats/min, * patient refusal

Keywords: lung recruitment, cesarean, lung compliance, atelectasis
risk of exposure and prevention of ticks and tick-borne diseases among foresters in alsace

Conditions: Lyme Borreliosis

Summary: ticks are blood-sucking arthropods that feed on vertebrate hosts. although wild and domestic animals are the primary source of tick blood meals, humans can be an accidental host. during a blood meal, a microorganism can be transmitted to the host who can develop a disease. all infectious diseases transmitted by ticks are referred to as tick-borne diseases (tbds). they are the most prevalent vector-borne diseases in the northern hemisphere. among these diseases, lyme borreliosis is the most common. in europe, lyme borreliosis does not cause high fevers (\> 38°c). therefore, when a patient presents with a high fever with the notion of exposure to ticks, another etiology must be suspected. anaplasma phagocytophilum and the tick-borne encephalitis virus are classically described as causing febrile syndromes. in france, ticks and tick-borne diseases are increasing, particularly those associated with the ixodes ricinus tick. this tick is mainly present in forest ecosystems with a peak of activity in may. foresters represent a population with biting ticks and tick-borne diseases, notably lyme borreliosis.


Eligibility criteria:
inclusion criteria: * major forester (≥18 years old) * male or female gender * onf (national forestry office) staff * regularly exposed to ticks in alsace (exclusively) * practicing regular forestry activities in a group * agreeing to participate in the study. exclusion criteria: * refusal to participate in the study

Keywords: tick-borne diseases lyme borreliosis febrile syndromes ixodes ricinus tick
metabolic heterogeneity underlying hypertriglyceridemia: hepatic triglyceride biosynthesis in humans with different insulin resistance phenotypes

Conditions: Insulin Resistance; Hypertriglyceridemia

Summary: the focus of this cross-sectional study is to determine the effects of tissue-specific (adipose tissue or muscle) vs global (combined) insulin resistance (ir) on hepatic triglyceride biosynthesis in humans, and to determine differential effects of an acute exercise intervention on hepatic triglyceride biosynthesis in these groups.

hypothesis: patients who primarily have muscle ir will have a greater percentage of lipids derived from de novo lipogenesis (dnl) than patients with combined muscle and adipose ir, and these subjects will respond more robustly to the effects of premeal exercise. with this study, the investigators will demonstrate that the mechanisms that drive triglyceride overproduction in insulin-resistant humans are dependent on which tissues are insulin resistant. to this end, investigators will determine whether subjects with muscle insulin resistance and adipose tissue insulin resistance utilize different mechanisms of triglyceride biosynthesis to assemble hepatic very low density lipoprotein (vldl), as compared with individuals with muscle insulin resistance but relative adipose tissue insulin sensitivity. additionally, investigators will see if adipose tissue insulin sensitivity predicts exercise responsiveness of hepatic triglyceride production. main study parameters/endpoints: difference in %dnl between subjects with global vs muscle-only insulin resistance as well as the differential effects of premeal exercise on %dnl in these groups.

Eligibility criteria:
inclusion criteria: * ability to give informed consent * overweight, defined as bmi 25-30 kg/m2 * modest hypertriglyceridemia, defined as fasting plasma triglycerides 1.5-3.0mm * high risk of insulin resistance, defined as fasting plasma insulin \>64pm * stable weight for at least 3mo prior to participation exclusion criteria: * active or chronic liver disease, kidney disease, congestive heart failure, unstable angina, history of acute cardiovascular events within 6mo of screening, history of seizures or syncope, or an active infection requiring antimicrobial therapy; * use of insulin, thiazolidinediones, sglt2 inhibitors, or sulfonylureas; * use of fibrates, omega 3 (fish oil), niacin, or pcsk9 antagonists; * use of systemic glucocorticoids within 60d prior to participation; * hematocrit \<35%; * pregnancy of breastfeeding; * active tobacco use, excessive alcohol intake (\>14u/wk), or history of drug abuse.
straberi microneedling for atrophic acne

Conditions: Atrophic Acne Scar

Summary: this pilot study will expand knowledge and application needling using the straberi microneedling device for the improvement of atrophic acne scarring

this pilot study will expand the knowledge and application of needling using the straberi microneedling device and its safety and benefits for improving the appearance of atrophic acne scarring. the pilot aims to objectively measure skin quality using the derma scan, photographs, and provide objective data showing improvement by way of the goodman and barons quantitative scar scale.

Eligibility criteria:
inclusion criteria: * derma scan showing aging including skin texture, wrinkles, brown spots, and pores. * patients willing to sign informed consent. * patients willing to be photographed and video documented * patients willing to consent to 3 months of treatment exclusion criteria: * history of eczema in the treatment area; psoriasis and any other chronic skin conditions * history of actinic (solar) keratosis in the treatment area; * history of hemophilia * history of diabetes * the presence of raised moles, warts on the targeted area. * collagen vascular diseases or cardiac abnormalities * blood clotting problems * active bacterial or fungal infection * facial melanosis * malignant tumors * immunosuppression * use of blood thinners or prednisone * corticosteroids within two weeks of the procedure * chronic liver disease * porphyria or other skin diseases. * patient not willing to sign informed consent. * tca peels in the last 5 weeks * subject currently has moderate to severe acne on the face. * microneedling within the last 6 months * subject has an active infection. * subject has a history of a bleeding disorder * subject has a history of keloidal tendency * subject has received ablative or non-ablative laser treatments in the previous 6 months. * subject has taken accutane within the previous 3 months.

Keywords: microneedling atrophic acne epistamp universal skincare institute
outcomes of endovascular revascularization in clti in patients associated with heel ulcers

Conditions: Lower Limb Ischemia Critical

Summary: the aim of the current study is to assess outcomes of endovascular revascularization of patients with clti associated with heel ulcers and identify possible predictors of healing of these ulcers.

peripheral arterial disease (pad) is a progressive disorder characterized by stenosis and/or occlusion of large and medium-sized arteries and affects the lower extremities more commonly than the upper extremity vessels, and may lead to a recurrent fatigue, cramping sensation, or pain that is known as intermittent claudication, which is the most recognized symptomatic subset of lower extremity pad. (1) chronic limb threatening ischemia (clti) is an advanced form of pad encompassing rest pain, lower limb ulceration or gangrene. it is associated with significant morbidity, mortality and healthcare resource utilization. (2) the society for vascular surgery (svs) lower extremity guidelines committee realized there was a need for a classification system for threatened limbs that encompassed the full spectrum of disease, as all existing classification systems fell short in this regard. so, they created the wifi (wound, ischemia, and foot infection) classification system to categorize these three major risk factors leading to amputation. (3) it contains the key limb status elements needed to gauge the severity of limb threat, which enables physicians to predict amputation risk more accurately. (4) either surgical or endovascular revascularization is the mainstay of therapy for clti. the continuous advance in the field of vascular interventional radiology has facilitated angioplasty through the development of low-profile balloon catheters, various small calibre stents, steerable and hydrophilic guide wires, road map facilities, vasodilators, and antiplatelet medication. (5) heel ulcers in patients with diabetes mellitus (dm) and pad are hard to heal. diabetic heel ulcer is a well-known, hard to-heal ulcer and is considered a major risk factor for lower extremity amputation. presence of foot ischemia, peripheral neuropathy with external trauma, and foot deformities will further increase the risk of amputation, and it is therefore highly likely that a patient with a diabetic heel ulcer with ischemia will have a great benefit from revascularization, especially if together with adequate infection control. (6)

Eligibility criteria:
inclusion criteria: * patients suffering from clti associated with heel ulcers who will undergo endovascular revascularization at assiut university vascular surgery department between august 2022 and november 2023. exclusion criteria: * patients with arterial thrombosis , dissection, or embolism. * known intolerance to the study medications or contrast agents * patients with failing or failed bypass grafts
open-label study of leuco-methylthioninium bis(hydromethanesulfonate) (lmtm) in subjects with alzheimer's disease or behavioral variant frontotemporal dementia (bvftd)

Conditions: Alzheimer's Disease; Behavioral Variant Frontotemporal Dementia

Summary: the purpose of this study is to provide subjects who have completed participation in a phase 2 or phase 3 trial of lmtm continued access to therapy and to evaluate the long-term safety of lmtm.


Eligibility criteria:
inclusion criteria: * subjects with all cause dementia and probable alzheimer's disease at enrollment and who completed participation in one of the following three taurx studies (inclusive of the 4-week post-treatment follow-up visit): trx-237-005, trx-237-008, or trx-237-015. * subjects with a diagnosis of probable bvftd at enrollment and who completed participation in taurx study trx-237-007 through visit 9 (week 52). * females, if of child-bearing potential, must practice true abstinence or continue to use adequate contraception and agree to maintain this throughout the study * subject, and/or, in the case of reduced decision-making capacity, legally acceptable representative(s) consistent with national law and ethics approval is/are able to read, understand, and provide written informed consent * has an identified adult caregiver who is willing to provide written informed consent for his/her own participation; is able to read, understand, and speak the designated language at the study site; either lives with the subject or sees the subject for ≥1 hour/day ≥3 days/week; agrees to accompany the subject to each study visit; and is able to verify daily compliance with study drug * able to comply with the study procedures exclusion criteria: * history of swallowing difficulties * pregnant or breastfeeding * clinically significant laboratory, pulse co-oximetry, electrocardiogram, or imaging abnormality (in originating study) or emergent intercurrent illness that, in the judgment of the principal investigator, could result in the risk of participation outweighing the potential benefit * current participation in, or intent to enroll in, another clinical trial of a drug, biologic, device, or medical food * in germany, subjects mandated to reside in a continuous care or assisted living facility or those whose willingness to participate in the clinical trial may be unduly influenced

Keywords: dementia alzheimer disease bvftd frontotemporal dementia neurodegenerative diseases brain diseases cognitive disorders
preventing hypoglycemia during exercise with proactive snacking on closed loop

Conditions: Type 1 Diabetes

Summary: this study is designed to look at how snacking during exercise may help prevent low blood sugars while subjects are on the "closed loop artificial pancreas." this system uses a continuous glucose sensor, an insulin pump, and a computer program that automatically determines how much insulin to give based on the sensor glucose level.

this study will be a randomized cross-over study as subjects will be studied under both study conditions - closed loop (cl) alone vs. cl + proactive snacking protocol). differences in the nadir blood glucose levels during exercise between the two study conditions will be the primary outcome measure.

Eligibility criteria:
inclusion criteria: 1. age 13-45 years 2. clinical diagnosis of t1d (formal antibody and/or genetic testing will not be required) 3. duration of t1d ≥ 1 year 4. hba1c ≤ 9 % 5. treated with continuous subcutaneous insulin infusion (pump) for at least 3 months 6. body weight \> 40 kg (to accommodate phlebotomy) 7. able to tolerate a 75-minute exercise period of moderate intensity 8. be willing to wear 2 subcutaneous glucose sensors (placed under the skin like a pump site) simultaneously during the inpatient portions of this study. 9. be in good general health without other acute or chronic illness that in the judgment of the investigator could interfere with the study or jeopardize subject safety 10. normal hematocrit 11. able to give consent (for children \<18 years, permission from parents and subject assent will be required) 12. female subjects of reproductive potential must be abstinent or consistently using appropriate family planning methods. exclusion criteria: 1. insulin resistant (defined as requiring \> 1.5 units/kg/day at time of study enrollment) 2. presence of any medical or psychiatric disorder that may interfere with subject safety or study conduct 3. use of any medications (besides insulin) known to effect blood glucose levels, including oral or other systemic glucocorticoid therapy. inhaled, intranasal, or rectal corticosteroid use is allowed along as not given within 2 weeks of the closed loop admissions. use of topical glucocorticoids is allowable as long as affected skin area does not overlap with study device sites. 4. subjects using herbal supplements will be excluded, due to the unknown effects of these supplements on glucose control 5. history of hypoglycemic seizure within last 3 months 6. female subjects who are pregnant, lactating, or unwilling to be tested for pregnancy

Keywords: type 1 diabetes closed loop insulin delivery systems exercise hypoglycemia