Kornimate/medical-research-clean huggingface dataset:
teriparatide for postsurgical hypoparathyroidism

Conditions: Hypoparathyroidism Post-surgical

Summary: this study evaluated the effects of teriparatide (forteo) on low calcium levels in the setting of thyroid surgery associated with low parathyroid hormone. the hypothesis was that teriparatide ( forteo) would shorten the length of hospitalization post thyroidectomy in patients with symptomatic hypoparathyroidism.

transient hypoparathyroidism with hypocalcemia occurs in up to 20 % of patients after surgery for thyroid cancer, multinodular goiter or graves' disease and is severe in around 3 to 18% of cases. severe hypocalcemia significantly lengthens their hospital stay. this study will evaluate the effects of teriparatide (synthetic parathyroid hormone, brand name forteo) on low calcium levels in the setting of thyroid surgery associated with low parathyroid hormone. this was a feasibility open-label, single-arm trial with historical matched controls with a planned enrollment of 15 patients with severe, symptomatic hypocalcemia that would be treated with teriparatide for a maximum duration of 3 weeks and compared the active subjects with 30 gender and age matched controls. therapy for hypocalcemia continued in accordance with current practice. the decision for discharge, as far as calcium is concerned, was to be reached when calcium level was \> 7.5 mg/dl and increased x 2 over 12 hours in an asymptomatic patient with stable therapy and no need for iv calcium in the last 24 hours. subjects were followed by phone and with blood tests 2 days after discharge and 9, 17 and 25 days after initiation of teriparatide. they were off teriparatide for 24 hours prior to testing on days 9, 17 and 25. if hypocalcemia recurred after 2nd week, teriparatide was continued for a 3rd week and then discontinued. if hypocalcemia recurred again current standard therapy for hypoparathyroidism was continued off teriparatide.

Eligibility criteria:
inclusion criteria: * patients post bilateral thyroid bed surgery (cancer, graves disease, multinodular goiter) * symptomatic hypocalcemia * total calcium \< 8 mg/dl persisting after 24 hours of therapy with calcitriol (minimum 0.25 mcg twice a day) and calcium supplementation (minimum 1.5 grams of elemental calcium per day) * parathyroid hormone (pth) level below low end of normal range exclusion criteria (all subjects): * renal failure * any prior parathyroid pathology * pre-existing hypercalcemia * metabolic bone diseases other than osteoporosis * pagets disease exclusion criteria (active treatment subjects only): * ongoing therapy with forteo for osteoporosis * active non-thyroidal malignancy or suspicion of residual thyroid malignancy * history of skeletal malignancies, primary or metastatic * pregnancy * active or recent urolithiasis * digitalis therapy * patients at increased baseline risk for osteosarcoma, i.e., family history of osteosarcoma or prior radiation therapy involving the skeleton * pediatric populations * unexplained elevations of alkaline phosphatase

Keywords: hypoparathyroidism
the greek study in the effects of colchicine in covid-19 complications prevention

Conditions: Corona Virus Disease 19 (Covid 19)

Summary: based on data regarding the effect of colchicine on the inflammasome nlp3 and microtubule formation and associations thereof with the pathogenetic cycle of sars-cov-2, the question arises whether colchicine, administered in a relatively low dose, could potentially have an effect the patients' clinical course by limiting the myocardial necrosis and pneumonia development in the context of covid-19. if present, this effect would be attributed to its potential to inhibit inflammasome and (less probably) to the process of sars-cov-2 endocytosis in myocardial and endothelial respiratory cells.


Eligibility criteria:
inclusion criteria: patients \>18 years old with laboratory confirmed sars-cov-2 infection (rt pcr) and body temperature \>37.5 degrees centigrade and at least two of: i. sustained coughing, ii. sustained throat pain, iii. anosmia and/or ageusia, iv. fatigue/tiredness, v. pao2\<95 mmhg. exclusion criteria: * pregnancy, lactation; * known hypersensitivity to colchicine * known hepatic failure * egfr\<20 ml/min * clinical estimation that the patient will require mechanical respiratory support in less than 24 hours * any clinical estimation of the attending physician under which the patient shall be excluded * qtc \> 450 msec (colchicine is not known to significantly prolong qtc, but may interact with other medications which prolong qtc). * participation in another clinical trial * under colchicine treatment for other indications * patient who is not likely to comply to study procedures
application of lateral position digestive endoscopy-guided endotracheal intubation in anesthesia for endoscopic diagnosis and therapy

Conditions: Endotracheal Intubation; Gastrointestinal Endoscopy; Airway Management; Lateral Position

Summary: this case series study evaluated whether placing a breathing tube using a camera (gastrointestinal endoscope) is safe and effective for patients lying on their left side during stomach and intestine exams under anesthesia. the main questions were: how often does the tube placement work on the first try? how long does it take to place the tube? are there any safety issues, like injuries or breathing problems? researchers enrolled 40 adults needing anesthesia for stomach/intestine exams. all participants had the breathing tube placed while lying on their left side using the camera-guided method. the steps included: positioning the patient on their left side with head/neck support. inserting a lubricated camera through the mouth to view the throat. placing the breathing tube into the windpipe under direct camera view. the method avoided the risks of moving anesthetized patients from their back to the side. it may reduce risks linked to repositioning patients during surgery. future studies with more participants and different medical teams are needed to confirm these results.


Eligibility criteria:
inclusion criteria: * the study population comprised individuals requiring endotracheal intubation during elective gastrointestinal endoscopy in the left lateral position exclusion criteria: * patients who declined informed consent were excluded
evaluation of innovative school-based interventions on health outcomes among primary school students during post covid-19 pandemic

Conditions: Childhood Obesity; Sleep Problems; Physical Activity

Summary: objectives: to evaluate the effects of innovative school-based (wejoy + wehop) on depressive symptoms, physical activities, and sleep quality among primary 3 to 5 school children. method: a sample of 408 school children will be recruited from primary schools in hong kong. this study will adopt a 2 two-group pre and post-design. participants are randomly assigned equally into 1 intervention group (wejoy+wehop) and 1 control group (routine extra curriculum activity). participants will be assessed at baseline and post-intervention. the outcomes are depressive symptoms, physical activities, and sleep quality, using the chinese version of the center for epidemiologic studies depression scale for children (ces-dc), the chinese version of the international physical activity questionnaire (ipaq-c), and the chinese version of the pittsburgh sleep quality index (psqi-c). data analysis: descriptive and inferential statistics will be performed to examine the research objectives.

the covid-19 pandemic has altered children's lifestyles, calling for particular attention. psychological problems, obesity, and sleep disturbance in children have become more prevalent throughout the covid-19 outbreak. it is vital to develop preventative interventions to enhance psychological well-being, prevent obesity, and improve sleep health. cognitive behavioural therapy (cbt) is effective in preventing psychological problems, obesity, and sleep problems in children. the provision of cbt faces obstacles such as a shortage of therapists, stigma, protracted wait times, and high costs. evidence revealed that children prefer interventions with interactive, relatable, and game-like content to improve their engagement. school-based cbt (wejoy) allows children to recognize, change, and partake in pleasant activities based on the cbt model. the wejoy comprises six weekly sessions on psychoeducation, cognitive restructuring, behavioural activation, emotional regulation, and self-monitoring. exergaming on the interactive floor (wehop) using a portable interactive projector games system. the wehop can gain a sense of autonomy, competence, and relatedness to help them regulate their emotions and maintain positive behaviours according to the self-determination theory. children participate in the interactive floor games by stepping on various targets and moving in response to the game's rules. combining task division, cooperation, and taking turns constitutes the collaboration mechanism.

Eligibility criteria:
inclusion criteria: * primary students ranged from primary 3 to 5 school children. * obtained consent forms from their legal guardians. exclusion criteria: * primary students in primary 1 due to the adaptation of the new environment. * primary 6 due to the preparation of the examinations for secondary schools.

Keywords: innovative school-based intervention school children cognitive behavioral therapy exergaming
gemcitabine and cisplatin in treating patients with metastatic or recurrent solid tumors

Conditions: Unspecified Adult Solid Tumor, Protocol Specific

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. combining more than one drug may kill more tumor cells. purpose: phase i trial to study the effectiveness of gemcitabine and cisplatin in treating patients who have metastatic or recurrent solid tumors.

objectives: i. determine the toxicity and maximum tolerated dose of gemcitabine and cisplatin in patients with metastatic or recurrent nonhematologic malignancies. outline: this is a dose escalation study of gemcitabine. patients receive gemcitabine iv on days 1 and 8, followed immediately by cisplatin iv over 2 hours on day 8. courses repeat every 3 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. cohorts of 3-5 patients receive escalating doses of gemcitabine until the maximum tolerated dose (mtd) is determined. the mtd is defined as the dose preceding that at which at least 2 of 5 patients experience dose limiting toxicity. patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. projected accrual: a maximum of 18 patients will be accrued for this study within 18 months.

Eligibility criteria:
disease characteristics: histologically or cytologically confirmed metastatic or recurrent nonhematologic malignancy that is not amenable to or has failed standard therapy measurable or evaluable disease no uncontrolled brain metastases patient characteristics: age: over 18 performance status: ecog 0-2 life expectancy: at least 8 weeks hematopoietic: neutrophil count at least 2,000/mm3 platelet count at least 100,000/mm3 hepatic: bilirubin no greater than 1.5 mg/dl sgot no greater than 5 times upper limit of normal renal: creatinine no greater than 1.5 mg/dl creatinine clearance at least 60 ml/min pulmonary: no respiratory failure other: not pregnant or nursing fertile patients must use effective contraception no active infection or other concurrent severe medical illness that would interfere with compliance prior concurrent therapy: biologic therapy: not specified chemotherapy: at least 4 weeks since prior chemotherapy (6 weeks since nitrosoureas) and recovered no prior cisplatin or gemcitabine endocrine therapy: not specified radiotherapy: at least 4 weeks since prior radiotherapy and recovered no concurrent radiotherapy surgery: not specified

Keywords: unspecified adult solid tumor, protocol specific
the aortic valve decalcification (avadec) trial

Conditions: Aortic Valve Stenosis; Multidetector Computed Tomography; Vitamin K 2; Randomised Clinical Trial

Summary: aortic stenosis is a common heart valve disease and due to the growing elderly population the prevalence is increasing. the disease is progressive with increasing calcification of the valve cusps. a few attempts with medical preventive treatment have failed, thus presently the only effective treatment of aortic stenosis is surgery. this study will examine the effect of menaquinone-7 (mk-7) supplementation on progression of aortic valve calcification (avc). the investigators hypothesize that mk-7 supplementation will slow down the calcification process.


Eligibility criteria:
inclusion criteria: participants in the danish cardiovascular screening trial (trials. 2015 dec 5;16:554) with an aortic valve calcification score above 300, but without aortic valve stenosis are eligible. exclusion criteria: * known aortic valve disease (peak velocity ≥3.0 m/s) * history of venous thrombosis or other coagulation disorders or use of vitamin k antagonists * disorders of calcium and phosphate metabolism * a life-expectancy \< 5 years
in-home versus hospital preoperative training for patients undergoing total knee replacement

Conditions: Knee Osteoarthritis

Summary: in this work the importance of the potentiation and recovery of the balance with a physiotherapeutic intervention that begins in the early preoperative phase is compared with the conventional postoperative rehabilitation. the objective is to evaluate the influence of a muscle enhancement protocol in which a specific work of balance is included, with the physical benefits that this entails for the evolution of the patient. it also seeks to verify if the teaching and recommendation of exercises at home as preparation and conditioning for the intervention of atr is effective, and to what extent, compared to a guided training in the hospital.


Eligibility criteria:
inclusion criteria: * subjects with severe knee osteoarthritis that have not been operated before of total knee replacement. * the score in berg scale must be greater than 21. * the score of the mini-mental state examination must be equal or greater than 20. * once the informed consent is read and explained, patients must accept and agree to participate in the study. exclusion criteria: * post-surgical infection of the operated knee. * pathology of central origin (i.e. cerebellar) that could interfere with balance or strength * vestibular pathology that could interfere with balance
sanguinate™ in sickle cell disease associated leg ulcer

Conditions: Leg Ulcer

Summary: sanguinate™ sickle cell disease associated leg ulcers.

this is an escalating, repeated-dose, open-label phase 2 study to test sanguinate (pegylated carboxyhemoglobin bovine) in patients suffering from leg ulceration associated with sickle cell disease (scd leg ulcer). patients will undergo consent and screening procedures at the time of presentation for leg ulcer treatment. eligible patients will begin a 3-week run-in period. a total of approximately fifteen (15) patients are expected to be screened in order to achieve an enrollment target of ten (10) evaluable patients for participation in the study. evaluable is defined as a patient receiving a minimum of three doses of investigational product. five (5) patients (cohort 1) will receive four (4) once-weekly 2-hour iv infusions of sanguinate at a dose of 320 mg/kg (8 ml). an additional five (5) patients (cohort 2) will receive six (6) once-weekly 2-hour iv infusions of sanguinate also at a dose of 320 mg/kg. each patient will be contacted by telephone approximately 24 hours after dosing to verify the safety status of the patient. one week following the treatment phase, patients will return to the study center for a final visit where safety assessments will be performed. during the final visit, patients will receive standard of care treatment of ulcer. all patients will receive once-weekly standard of care (soc) therapy for scd leg ulcer for the duration of the study. soc includes dressing the wound with multi-layer, short stretch, compression bandaging. non-adherent, medical-grade foam will be used as the wound contact layer and primary dressing.

Eligibility criteria:
inclusion criteria: * properly consented patients suffering from sickle cell disease (hb-ss or hb- sβ° genotype) associated leg ulcer. * presence of leg ulcer for at least 4 weeks * venous clinical severity score of moderate to severe (defined as ≥12) * leg ulcer below the knee exclusion criteria: * patient presenting with a clinically \& laboratory confirmed bacterial, fungal or acid fast organisms * patient has a recent acute complication of sickle cell disease (e.g., pain crisis within 7 days, or acute chest syndrome within 21 days) * patient is planning to be pregnant, is pregnant, or is breast-feeding * presence of moderate to severe renal insufficiency (crcl \< 30 ml/min) or chronic kidney disease, or of moderate to severe hepatic insufficiency (child-pugh class b or c) * patients with more than 3 times the upper limit of normal laboratory reference range * concurrent or recent prior treatment (within 90 days) with an investigational medication * patients currently receiving treatment with hydroxyurea must be on stable dose for at least 30 days * receipt of a blood transfusion within 21 days

Keywords: leg ulcer lu sanguinate qol scd sickle cell disease sickle cell anemia leg wound leg skin lesion
effects of positional therapy on pulmonary physiology in patients undergoing mechanical ventilation.

Conditions: Critical Illness

Summary: the aim of this project is to evaluate the effects of positional changes in mechanically ventilated patients.

in critically ill patients undergoing invasive mechanical ventilation (imv), several negative effects converge, promoting the development of collapse in the dorsal areas of the lung. these among others include deep sedation, relaxation, prolonged immobility and the supine position. this results of an added impairment in lung function both in the mechanical and gas exchange. in addition lung collapse contributes to a significant increase in the heterogeneity the distribution of alveolar ventilation and perfusion that may increase the risk of ventilator-induced lung injury (vili). postural therapy is widely recommended as prevention/treatment of pressure ulcers, whose presence, according to the spanish society of intensive care medicine (semicyuc), is a quality criterion for intensive care units (icus), with a prevalence of 18% in these units compared to 7.8% in adult hospitalization. however, how postural changes may affect lung function is an aspect that has been scarcely studied. given the strong influence of gravity on lung function, positional changes can produce significant alterations in the distribution of trans-pulmonary pressures (a decrease along the vertical gravitational axis of approximately 0.25 cmh2o per cm). depending on the severity, distribution and location of the respiratory pathology, positional changes may have a significant effect either benefiting or impairing the patient's condition. the investigators will dynamically assess the effects of routine lateral positioning up to 30-40º by means of electrical impedance tomography (eit), a non-invasive, radiation-free functional bedside imaging technique that allows to monitor the regional distribution of ventilation and perfusion.

Eligibility criteria:
inclusion criteria: * patients undergoing imv under sedation, in a controlled ventilatory modality in passive conditions (i.e. without any spontaneous inspiratory efforts by the patient). * signature of the informed consent by family member or legal representative. exclusion criteria: * presence of any clinical contraindication for postural therapy, including patient haemodynamic instability, traumatism, pathology or any other cause. * contraindication for the placement of the eit electrode belt due to unstable spinal cord injury or other skin injuries or wounds in the thoracic region (surgical, traumatic, etc.) * assisted ventilatory modes in a non-passive breathing patient. * hypernatremia * patients with pacemakers or implantable automatic defibrillators (iad).
2019-06 triscend study

Conditions: Tricuspid Valve Regurgitation; Heart Valve Diseases; Cardiovascular Diseases

Summary: prospective, multi-center study to assess safety and performance of the edwards evoque tricuspid valve replacement system

the study is a multi-center, prospective single arm study designed to evaluate the safety and performance of the edwards evoque tricuspid valve replacement system.

Eligibility criteria:
key inclusion criteria: * functional or degenerative tr moderate or greater * symptomatic despite medical therapy or prior hf hospitalization from tr * the local site heart team determines that the patient is appropriate for transcatheter tricuspid valve replacement key exclusion criteria: * tricuspid valve anatomic contraindications * need for emergent or urgent surgery or any planned cardiac surgery within the next 12 months * hemodynamic instability * refractory heart failure requiring advanced intervention * currently participating in another investigational study in which the patient has not reached a primary endpoint

Keywords: tricuspid regurgitation transcatheter replacement functional degenerative regurgitation valve replacement cardiovascular disease
safety study of aminolevulinic acid (ala) to improve visibility of brain tumors during surgery

Conditions: Glioblastoma

Summary: a one time oral dose of ala is taken before surgery. the medication makes the tumor visible under ultraviolet light which allow the surgeon to see more of the tumor for a more complete removal.

patients with primary neoplastic brain tumors (grades ii-iv) will participate in this trial. each patient will have been evaluated and found to have such a tumor by history and recent imaging studies (mri) and deemed a surgical candidate based on current neurosurgical standards of care.

Eligibility criteria:
inclusion criteria: * suspected primary brain tumor * 18 years of age or more * normal marrow and organ function * eastern cooperative group performance status ≤ 2 * women of childbearing potential must use adequate birth control * ability to understand and willingness to sign a written informed consent form * life expectancy not a consideration exclusion criteria: * receiving any other investigational agents * history of allergic reactions to ala * personal or family history of porphyrias * liver disease in the past year * uncontrolled intercurrent illness * pregnant or lactating women * inability to undergo mri with contrast

Keywords: brain tumor glioma surgical resection ala ultraviolet light