Kornimate/medical-research-clean huggingface dataset:
non-invasive monitoring of endovascular repair of abdominal aortic aneurysm (vba)

Conditions: Cardiovascular Diseases; Abdominal Aortic Aneurysm

Summary: this study evaluates a novel noninvasive method to dynamically monitor the effect of abdominal aortic aneurysm (aaa) and endovascular treatment of aaa (evar) on arterial pulse wave

abdominal aortic aneurysm (aaa) develops slowly and degeneratively (increasing diameter, wall tension, thinning and decreased wall strength, altered compliance) which affects the aortic pressure and wave reflection. in 50% of cases, aaa rupture may lead to death and 50% of the remaining patients referred to hospital die. this results in high costs and preventable loss of lives. aaa can also be detected by pulse wave (pw) analysis. which could enable development of easy to use, affordable and accurate methodology for the detection of aaas. the measurement system used in the present study is capable of wireless recording of pws from several different locations utilizing two different sensor modalities (blood-volume related photoplethysmographic (ppg) pws and dynamic blood pressure pws). the objective is to study pws in the detection of aaa and the effects of endovascular repair (evar) and whether adverse effects (i.e. endograft failure) can be detected. it is hypothesized that aaa and failure of the operation can be detected by pw features, especially by printed flexible sensors which will improve the usability, patient comfort and safety (hygiene). the technology could make it possible to screen aaas at lower costs even in the municipal health centers or by the patients themselves, at similar accuracy, without skilled personnel operating the diagnostic devices and therefore improve the cost effectiveness of aaa screening resulting in significant savings, resource reallocation in the healthcare and also improved patient safety and prevention of deaths. it could also enable patient-centered, comfort follow-up for patients treated by evar.

Eligibility criteria:
inclusion criteria: * the patient has been clinically examined at policlinic of vascular surgery * the patient has been examined with computed tomography (ct) imaging * the patient has been considered a candidate for the evar of the aaa exclusion criteria: * a patient has a pacemaker * a medical doctor decides that the measurement disturbs or risks the subject's treatment process * subject's denial (or withdrawal) * a patient has at least one amputated limb * the age of the test subject candidate is less than 18 years * a test subject candidate is not able to understand the study or is not legally competent * a test subject candidate has ehlers-danlos syndrome or marfan syndrome
a phase 2 dose escalating study to evaluate the safety and efficacy of cb-03-01 cream in subjects with facial acne vulgaris

Conditions: Acne Vulgaris

Summary: cb-03-01 is being developed for the topical treatment of acne vulgaris, an androgen-dependent skin disorder. the purpose of this study is to compare the safety and efficacy of multiple concentrations of cb-03-01 to vehicle in the treatment of acne vulgaris.


Eligibility criteria:
inclusion criteria: * subject is male or non-pregnant female. females must be post-menopausal, surgically sterile or using highly effective birth control methods. * subject has provided written and verbal informed consent/assent. * subject has facial acne vulgaris (including the nose). * subject is willing to comply with study instructions and return to the clinic for required visits. * subject has used the same type and brand of make-up, other facial products (including cleanser) and hair products (e.g., shampoo, gel, hair spray, mousse, etc.) for at least one month prior to the study start and agrees to continue his/her other general skin and hair care products and regimen for the entire study. exclusion criteria: * subject is pregnant, lactating, or is planning to become pregnant during the study. * subject is currently enrolled in an investigational drug or device study. * subject has received an investigational drug or been treated with an investigational device within 30 days prior to the study start. * subject has the need or plans to be exposed to artificial tanning devices or excessive sunlight during the trial * subject has used any of the following topical anti-acne preparations or procedures on the face: * topical anti-acne treatments including but not limited to over-the-counter acne cleaners or treatments, benzoyl peroxide, antibiotics, azelaic acid, sulfa based products, corticosteroids and salicylic acid within two weeks of the initiation of treatment. * retinoids, including tazarotene, adapalene, tretinoin, within four weeks of the initiation of treatment. * light treatments, microdermabrasion or chemical peels within eight weeks of the initiation of treatment. * subject has used the following systemic anti-acne medications: * corticosteroids (including intramuscular and intralesional injections) within four weeks of the initiation of treatment. inhaled, intranasal or ocular corticosteroids are allowed if use is stable (stable use is defined as dose and frequency unchanged for at least four weeks prior to the initiation of treatment). * antibiotics within four weeks of the initiation of treatment with the exception of five days or less of antibiotic therapy during this period, but with no antibiotics use permitted within one week prior to the initiation of treatment. * spironolactone within eight weeks of the initiation of treatment with the exception of five days or less of spironolactone therapy during this period, but with no spironolactone use permitted within one week prior to the initiation of treatment. * retinoid therapy within six months of the initiation of treatment.

Keywords: acne anti-androgen clascoterone cassiopea
amendment (g) unblinded extension phase of somatropin in patients with idiopathic short stature

Conditions: Growth Disorder

Summary: after approval of amendment (g), patients who were still receiving study drug at the time were scheduled for a study visit. in addition, patients who had discontinued early from the core, blinded phase of the study were contacted. all of these patients were offered the opportunity to enter the unblinded extension phase (if they met eligibility criteria) and continue somatropin treatment (regardless of initial treatment randomization) until they reached final height.


Eligibility criteria:
inclusion criteria: participation in core, blinded phase and ability to be contacted by investigators. for patients who were on treatment at the time of amendment (g), growth velocity greater than or equal to 1.5 cm/year measured over the prior 12-month period. for patients who had chosen to discontinue treatment in the core, blinded phase, bone age less than or equal to 16 years for boys and less than or equal to 14 years for girls. exclusion criteria: diabetes mellitus. history, evidence or signs of active malignancy within 5 years prior to the start of the extension phase. any condition or medication that, in the opinion of the investigators, might significantly increase the risk or decrease the efficacy of growth hormone therapy.
choline supplementation as a neurodevelopmental intervention in fetal alcohol spectrum disorders study

Conditions: Fetal Alcohol Spectrum Disorders

Summary: this is a randomized, double-blind controlled trial of choline supplementation in children with fetal alcohol spectrum disorders (fasd). the study is comparing two administration durations (3 months vs. 6 months) of choline. the primary outcome measures are cognitive measures.

this project is the fourth in a series of randomized, double-blind controlled trials of choline bitartrate in children ages 2-5 (under 6) years with prenatal alcohol exposure. pre-clinical data suggests that choline may attenuate the cognitive deficits caused by prenatal alcohol exposure (especially memory deficits). this study will evaluate the effects of daily choline supplementation in two dosing regimens (3 months choline vs. 6 months choline). outcome measures include an elicited imitation memory paradigm, iq measures, and measures of memory and executive functioning, and behavior.

Eligibility criteria:
inclusion criteria: * ages 2.5 years to 5 years old (\<6 years of age) at enrollment * prenatal alcohol exposure * available parent or legal guardian capable of giving informed consent for participation. exclusion criteria: * history of a neurological condition (ex. epilepsy, traumatic brain injury) * history of a medical condition known to affect brain function * other neurodevelopmental disorder (ex. autism, down syndrome) * history of very low birthweight (\<1500 grams)
ultrasound tfp (transversalis fascia plane) for analgesia after iliac crest bone graft harvest

Conditions: Patients Scheduled for Iliac Crest Bone Graft Harvest During Upper or Lower Limb Surgery

Summary: iliac crest bone graft harvest is associated with acute pain that can lead to chronic postoperative pain. local anesthetic infiltration and regional anesthesia could be of interest to reduce opioid consumption during and after surgery, reduce hyperalgesia and the associated risk of chronic postoperative pain. in this surgery, local anesthetic infiltration of the iliac crest is associated with a pain reduction compare with placebo. some studies have shown the benefit of a tap (transversus abdominal block) for postoperative analgesia after iliac crest bone graft harvest. the tfp block (transversalis fascia plane block) has been recently described. considering the nerves trajectories, the tfp block is probably anatomically the most appropriate block for analgesia after iliac crest bone graft harvest. the aim of this study is therefore to assess the benefit of an ultrasound tfp block for analgesia after iliac crest bone graft harvest compare with local anesthetic infiltration design is prospective, randomized, double blind, controlled study


Eligibility criteria:
inclusion criteria: * age \> 18 years * patients scheduled for iliac crest bone graft harvest during upper or lower limb surgery exclusion criteria: * allergy to ropivacaine, propofol, paracetamol, remifentanil, morphine, cisatracurium, ketoprofene, nefopam * weight \< 50 kg * pregnancy * severe psychiatric disorder * paraplegia or tetraplegia * spinal anesthesia * contra indication to ketoprofene: age ≥ 75 years, renal insufficiency (creatinine clearance \< 50 ml/min), active gastric ulcer, past of asthma with nsaid * contra indication to nefopam: severe cardiac insufficiency, glaucoma, prostate hypertrophy, epilepsy * contra indication to paracetamol: severe hepatic insufficiency * severe respiratory insufficiency * abnormal hemostasis or anticoagulant treatment * chronic use of morphine
portec-4a: molecular profile-based versus standard adjuvant radiotherapy in endometrial cancer

Conditions: Endometrial Cancer Stage I; Endometrial Cancer Stage II

Summary: this is prospective, multicenter, randomised phase iii trial among women with endometrial cancer with high-intermediate risk features to investigate the role of an integrated clinicopathological and molecular risk profile to determine if participants should receive no adjuvant therapy, vaginal brachytherapy or external beam radiotherapy based on a favourable, intermediate or unfavourable profile as compared to standard adjuvant vaginal brachytherapy.

adjuvant therapy for women with endometrial cancer has increasingly been tailored to prognostic factors to prevent overtreatment and select those women for adjuvant treatment who will have a clinically relevant reduction of the risk of relapse by the adjuvant treatment. risk profiles have traditionally been based on clinicopathological factors such as age, stage, grade, lvsi and depth of invasion. newer, both molecular-genetic (the cancer genome atlas subgroups) or immunohistochemistry-based (l1-cam) risk factors have become available which are strongly related to outcomes and risk of cancer spread. in a comprehensive analysis of the portec-1 and-2 biobank an integrated clinicopathological and molecular risk profile was determined which separated the current high-intermediate risk group of endometrial cancer in 3 separate groups (favourable, intermediate or unfavourable) with clearly separated outcomes, which is now prospectively tested in the clinic to determine adjuvant treatment. this is the first randomised trial using the molecular risk factors to assign adjuvant treatment for women with stage i-ii high-intermediate risk endometrial cancer.

Eligibility criteria:
inclusion criteria: * histologically confirmed endometrioid type endometrial carcinoma, international federation of gynecology and obstetrics (figo) 2009 stage i, with one of the following combinations of stage, grade, age, and lymph-vascular space invasion (lvsi): 1. stage ia, grade 3 (any age, with or without lvsi) 2. stage ib, grade 1 or 2 and age \>60 years 3. stage ib, grade 1-2 with documented lvsi 4. stage ib, grade 3 without lvsi 5. stage ii (microscopic), grade 1 * world health organization (who)-performance status 0-2 * written informed consent exclusion criteria: * any other stage and type of endometrial carcinoma * histological types serous carcinoma or clear cell carcinoma (at least 10% if mixed type), or undifferentiated or neuroendocrine carcinoma * uterine sarcoma (including carcinosarcoma) * previous malignancy (except for non-melanomatous skin cancer) \< 5 yrs * previous pelvic radiotherapy * expected interval between the operation and start of radiotherapy exceeding 8 weeks

Keywords: radiotherapy vaginal brachytherapy molecular risk factors
effect of non-invasive neurostimulation on variability of heart rate in patients with heart failure.

Conditions: Heart Failure

Summary: this study is a clinical trial, and may also be referred to as a "before and after" study, in which all subjects receive the same treatment and their condition is checked before initiation and after various times of treatment. this study will be carried out at the laboratory of physiotherapy in cardiorespiratory research, located in the building of the postgraduate course in physiotherapy at the health sciences center (ccs) of the federal university of parahyba (ufpb), from may 2023 to may 2020. 2024. after screening, patients will undergo assessment and anthropometric measurements. subsequently, interventions will be carried out

the patients will perform three sessions of hd-tdcs (stimulation, inhibition and shan) of twenty minutes with an intensity of three milliamps in the left temporal cortex. before and after each session, patients will perform the six-minute walk test. heart rate variability (hrv) will be evaluated throughout the protocol through holter (3-channel). at the end, the perception of exertion and the level of dyspnea of the patient, distance covered and blood pressure will be evaluated.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of heart failure; * over eighteen years old; * classified in functional class ii and iii of the new york heart association. exclusion criteria: * patients with neurological or pulmonary diseases; * patients with cognitive alterations that make it impossible to execute commands; * with physical limitations that prevent the performance of the exercise protocol.

Keywords: heart failure transcranial direct current stimulation six minute walk test
treatment adherence with twin-blocks for correction of class ii malocclusion

Conditions: Compliance, Patient; Treatment Adherence

Summary: to compare the effect of two control intervals (once every 4th week or once every 6th week) on the wear time of a twin block removable appliance.

if the patient fulfill the inclusion criteria, they will be asked to participate in the study. after being informed about the study and the planned treatment, participants and their guardians will give their written consent to participate in the study. therafter they will be consecutively randomized into one of two groups with different control intervals, group 1 (every 4th week) and group 2 (every 6th week). they will recieve a clinical and radiological examination and then start treatment with a twin block appliance. the twin block appliance will be fitted with a digital timer module to measure the wear time of the appliance objectively.

Eligibility criteria:
inclusion criteria: * healthy patients (asa 1 and 2) * overjet of 6 mm or more * incomplete lip closure exclusion criteria: * severe chronic conditions such as asthma or allergies * neuroopsychiatric disorders * craniofacial syndromes * previous orthodontic treatment

Keywords: orthodontic removable compliance adherence twin block
sirolimus, tacrolimus and short course methotrexate for prevention of acute gvhd in recipients of mismatched unrelated donor allogeneic stem cell transplantation

Conditions: Stem Cell Transplantation

Summary: the primary objective of this trial is to study the safety and efficacy of a novel regimen of sirolimus, tacrolimus and methotrexate as prophylaxis against acute graft versus host disease (gvhd) in recipients of mismatched unrelated donor stem cell grafts. methotrexate is administered in a low dose format of 5mg/m2 on days +1,3 and 6 only.


Eligibility criteria:
inclusion criteria: * patients must have an identified 8/10 or 9/10 matched unrelated donor identified following a formal search with confirmatory typing through the national marrow donor program as the best available donor. no matched sibling or fully matched unrelated donor has been identified. hla typing of donor and recipient will be performed by high resolution molecular typing at hla a, b, c and drb1/dq loci. patients whose best available donor is matched at 8/10 loci must have at least one of the mismatches at the dq locus. (no more than one mismatch at hla a,b,c,dr allowed). * candidates for this trial will meet the following criteria: 1. adequate organ function for conditioning type: for patients receiving ablative conditioning * left ventricular ejection fraction \>45% * dlco \>50% * creatinine \<1.5 * hepatic enzymes \<3x upper limit of normal. * kps \>70% for patients receiving non-ablative conditioning: * kps \>70% 2. patients with the following diseases will be considered eligible: * aml in first remission with high risk features (poor risk cytogenetic abnormalities9, persistent elevated blast count on day +15 or recovery marrow after induction therapy). * aml beyond first remission * all in first remission with high risk features (ph+, t4:11) * all beyond first remission * high risk myelodysplasia (raeb-ii, raeb-i with poor-risk cytogenetics) * recurrent aggressive non-hodgkins or hodgkins lymphoma (indolent histologies excluded) who have failed autologous transplant or have had inadequate response to salvage therapy. * cml with transformation * cll with transformation or fludarabine failure. * severe aplastic anemia with recurrence or failure after immunosuppressive therapy. exclusion criteria: * prior allogeneic transplantation * active cns leukemia. * female patients who are pregnant or breast feeding * karnofsky performance status \<70%. * active viral, bacterial or fungal infection. * patients seropositive for hiv -1,2; htlv -1,2 (due to the additional immunodeficiency induced by transplantation and immunosuppressive therapy) requirement for antifungal prophylaxis with voriconazole for the first 30 days is prohibited. * patients not providing informed consent.

Keywords: allogeneic
staple vs. suture in robotic prostatectomy

Conditions: Prostate Cancer

Summary: the purpose of the study is to compare the results of three standard of care surgical methods \[stapling versus selective suture ligation (cut, then sew) versus single suture ligation (sew, then cut) of the dorsal venous complex (dvc)\] during robotic prostate surgery to see which is better for the patient's recovery.

the dorsal venous complex (dvc) lies on top of the prostate gland, and carries blood away from the penis. it has to be tied off, or ligated, to remove the prostate gland. the dvc lies very close to nerves that help men get and maintain erections. in addition, the dvc is close to muscles that control passing urine. how the dvc is handled during prostate surgery may result in cancer being left behind to grow and spread in the body. the purpose of this study is to compare the results of stapling versus selective suture ligation (cut, then sew) versus single suture ligation (sew, then cut) of the dvc during robotic prostate surgery to see which is better for the patient's recovery. this research is being done because doctors do not know which of these three commonly-used methods is better to reduce blood loss and reduce the chance of cancer left behind during surgery, and regain urine control and improve erectile function after surgery. doctors also do not know if these methods affect the prostate-specific antigen (psa) level in the blood after surgery.

Eligibility criteria:
inclusion criteria: * males over 18 years of age * must be scheduled to undergo standard of care robot-assisted laparoscopic prostatectomy (ralp) * must sign informed consent to be randomized between the three surgical arms exclusion criteria: * patient is unwilling or unable to provide informed consent
ursodiol in huntington's disease

Conditions: Huntington Disease

Summary: the purpose of this study is to evaluate the safety of the drug ursodiol (ursodeoxycholic acid, udca) in people with huntington's disease (hd) and to explore how the compound is processed by the body.

huntington's disease is an inherited neurodegenerative disease that causes a movement disorder, dementia, and psychiatric and behavioral disturbance in affected individuals. tauroursodeoxycholic acid (tudca) is a bile acid synthesized in the liver by the conjugation of taurine to ursodeoxycholic acid (udca). it is thought to function as an anti-apoptotic agent in hd, evidenced by studies in toxic cell models and both toxic and transgenic rodent models of the disease. ursodiol is a commercially-available exogenous form of udca, the precursor of tudca. although the compound has an established dosing, safety, tolerability and efficacy profile in patients with hepatobiliary disorders, gaps exist in the understanding of the pharmacokinetics / pharmacodynamics of the compound, particularly in patients with normal gastrointestinal function, and no human data exist for its therapeutic use in neurodegenerative disorders. the specific aims of this study are: 1. to establish whether treatment with the drug ursodiol will result in measurable levels of its bile acid metabolites in serum and csf at standard oral doses; and whether a dose-response can be detected using these measures. 2. to establish a preliminary safety and tolerability profile of the drug in subjects with hd.

Eligibility criteria:
inclusion criteria: * all subjects will be age 18 or older * all subjects will have manifest huntington disease determined by clinical exam plus either documented prior dna testing for the hd gene or a documented family history of the disease exclusion criteria: * subjects taking oral contraceptives, cholestyramine, colestipol, or aluminum-based antacids will be excluded * subjects with known allergy or other contraindication to the study drug will be excluded * subjects with bleeding diathesis, or on coumadin or mandatory aspirin will be excluded * subjects with unstable medical or psychiatric illness will be excluded * subjects with clinically significant lab / ekg abnormalities at screening will be excluded * subjects who are currently pregnant or breastfeeding will be excluded

Keywords: huntington chorea chorea hereditary tauroursodeoxycholic acid ursodeoxycholic acid tudca udca