Kornimate/medical-research-clean huggingface dataset:
comparison of two techniques of sciatic nerve block with levobupivacaine 0.5% in orthopedic surgery

Conditions: Anesthesia

Summary: the purpose of this study is to evaluate the latency period (timing between the injection of the local anesthetic and the onset of complete sensory nerve block) of two approaches for ultrasound-guided popliteal sciatic nerve block: one of the approaches is the injection of the anesthetic just at the site of the bifurcation of the sciatic nerve and the other one is injecting the local anesthetic at least 2 cm beyond the bifurcation of the aforementioned nerve. our main hypothesis is that the first approach will decrease the latency period, and probably, will increase the success rate of the nerve block as well as patient satisfaction.

compare the effectiveness of nerve blockade at the bifurcation site of the sciatic nerve versus distal (tibial and peroneal) using only levobupivacaine 0.5%. the primary outcome is the latency period of the nerve blockade; the secondary outcomes are rate of success of the procedure as well as patient satisfaction.

Eligibility criteria:
inclusion criteria: * patients scheduled for ankle or foot surgery at hospital pablo tobón uribe and clínica ces. * physical status classification of the american society of anesthesiologists (asa) 1-3. * age: 18-70 years. * weight: 40-100 kg * taller than 140 cm. exclusion criteria: * no patient acceptance. * contraindications for nerve block (coagulopathy, local anesthetics allergy, sepsis, infection at the site of puncture). * neuropathy or myopathy affecting the lower limb. * psychiatric or neurological diseases that alter the evaluation of patient. * arrhythmias. * heart failure. * diabetes mellitus. * pregnancy. * language barriers. * anticoagulation.

Keywords: nerve block sciatic nerve ultrasonography orthopedics hallux valgus amputation arthrodesis arthroscopy fracture fixation osteotomy tendon transfer tenodesis tenotomy orthopedic procedure
a digital solution for breast cancer patients

Conditions: Breast Cancer

Summary: sidekick health has developed an interactive digital health program (sk-421) to support breast cancer patients. the study will be a single center pilot study with an intervention group and a comparison group aiming to recruit 66 breast cancer patients prescribed to surgery, chemotherapy, radiation and/or hormonal therapy according to standard breast cancer treatment. this pilot study will determine whether the digital health program, supporting lifestyle changes, can positively impact management of side effects, quality of life, physical activity and fitness and medication adherence in this patient population. patients will be randomized to receive either the standard of care (soc) treatment alone or soc with the addition of the digital healthprogram.

many cancer survivors do not achieve previous levels of function and report prolonged fatigue, cognitive limitations, depression, anxiety, sleep problems, pain, or sexual dysfunction for up to ten years after diagnosis. in addition to symptoms related to the cancer itself, most cancer treatments cause physical and psychosocial side-effects that can affect a patient's physical function, mental well-being, and overall quality of life (qol). these treatment-related side effects are most prominent during treatment but can also persist long after completion of the treatment with some becoming chronic and others developing as late side effects. the european society of medical oncology (esmo) recommends encouraging patients towards adopting a healthy lifestyle including diet modification and exercise as well as addressing psychosocial needs. sidekick health developed a 14-week digital health program (sk-421) with patient support aiming to increase the health related quality of life of breast cancer patients and improve management of treatment-related side effects. the aim of this study is to assess the effectiveness of this digital health program when added to standard of care treatment. by comparing the effect of adding a digital solution to the standard of care with standard of care only, this study will investigate the impact of a holistic, digitally delivered health program on quality of life, physical activity, medication and treatment-related side effects. the main analysis is done after 14 weeks, with exploratory follow-up analysis at 26 and 38 weeks.

Eligibility criteria:
inclusion criteria: * female adults diagnosed with breast cancer stage 1, 2, 3 or 4 * treatment plan includes surgery and (neo)adjuvant treatments: targeted-, chemo-, endocrine-, or radiotherapy. * fluent in verbal and written icelandic or english * capacity to give informed consent * capacity to operate a smartphone exclusion criteria: * not owning a smartphone compatible with the sidekick health app or not willing to have it installed on their device * not able to comply with study intervention/scheduled measures and visits, as assessed by oncologist * pregnancy

Keywords: breast cancer digital solution lifestyle change quality of life digital intervention side effects medication adherence physical activity
the accuracy of brain biological electrical impedance tomography screen for supratentorial tumors

Conditions: Brain Tumor; Brain Edema

Summary: compared with mri or ct, brain biological electrical impedance tomography were performed on patients with supratentorial tumors and healthy people . the auc (area under the curve) of roc, which is associated with the increased maximum and the difference between left and right equilibrium of impedance value, is calculated. the specificity of brain biological electrical impedance tomography in screening supratentorial tumors are evaluated. to compare the changes of parameters detected by brain biological electrical impedance tomography, the enrolled brain tumor patients with cerebral edema were paired with themselves and intravenous infusion of mannitol so that the sensitivity of this device in monitoring cerebral edema can be evaluated.

compared with mri or ct, brain biological electrical impedance tomography were performed on patients with supratentorial tumors and healthy people . the auc (area under the curve) of roc, which is associated with the increased maximum and the difference between left and right equilibrium of impedance value, is calculated. the specificity of brain biological electrical impedance tomography in screening supratentorial tumors are evaluated. to compare the changes of parameters detected by brain biological electrical impedance tomography, the enrolled brain tumor patients with cerebral edema were paired with themselves and intravenous infusion of mannitol so that the sensitivity of this device in monitoring cerebral edema can be evaluated.

Eligibility criteria:
inclusion criteria: 1. 18 ≤70 years old, male or female; 2. preoperative patients who had been diagnosed with supratentorial tumors by mri/ct or other conventional methods or healthy people (23 cases each); 3. the longest diameter of the brain tumor is ≥3 cm; 4. informed consent has been signed exclusion criteria: 1. severe systemic compound injury or hemorrhagic shock; 2. epilepsy, poisoning symptoms; 3. in critical condition; 4. patients with brain wounds or acute inflammation; 5. lactation and pregnant women; 6. those who have no informed consent ability or cannot sign by themselves; 7. the investigator considers it inappropriate for the patient to participate in this clinical trial

Keywords: electrical impedance tomography supratentorial brain tumors
phase 2a randomized, double-blind study of oleoyl-estrone in male morbidly obese adults

Conditions: Obesity

Summary: multi-center, multiple-dose, randomized, double-blind, three-arm, placebo-controlled study of fixed-dose repeated oral dosing for 30 days of 10 mg and 30 mg mp-101 and placebo in obese subjects.


Eligibility criteria:
inclusion criteria: * subject is willing and able to provide signed informed consent. * subject is a male and is between 18-60 years of age. * subject is obese as defined as a bmi of 40 - 55. * subject is reasonably healthy and have a reasonably acceptable medical history * subject has a stable weight for the past 30 days per subject report. * subject who has at least one factor of the metabolic * subject exhibits stable behavior patterns with regard to smoking and exercise * subject can read, speak and write the english language and agrees to follow study procedures. exclusion criteria: * subjects who have received any investigational medication within 3 months prior to administration of study drug * subjects with confirmed positive results of uds or alcohol * subjects who are unwilling to return to the clinical research center on specified days during the treatment periods. * subjects who have taken exclusionary medication * subjects with any clinically significant laboratory abnormality or illness which, in the opinion of the investigator, would contraindicate study participation * subjects who have a history of testing positive for hepatitis b virus, hepatitis c virus, or hiv. * subject has been involved in a formal or informal (self-imposed) diet regimen within the last 30 days. * subject has a confirmed diagnosis or history of cancer, with the exception of nonmelanoma skin cancer. * subject is otherwise unsuitable for the study, in the opinion of the investigator.
effectiveness of telescopic magnification in the treatment of amblyopia

Conditions: Amblyopia

Summary: amblyopia is a visual impairment of one eye that results from disuse of that eye during early brain development. the standard treatment for amblyopia consists of patching or pharmacological penalization of the sound eye. unfortunately, approximately 50% of amblyopic children do not respond to these therapies, with poor compliance being a major factor in treatment failure. one new treatment strategy involves patching the sound eye while using a telescopic device on the amblyopic eye to magnify the images formed in the amblyopic eye. children were randomized to receive either daily patching of the sound eye for 30 minutes only (patching only group), or daily patching of the sound eye for 30 minutes plus simultaneous use of a telescopic device by the amblyopic eye during patching (patching plus telescope group).

the goal of the present investigation was to conduct a prospective randomized clinical study to further evaluate the effectiveness of telescopic magnification plus patching vs patching alone on different types of amblyopia in patients who had failed previous treatment.

Eligibility criteria:
inclusion criteria: * aged 4-17 years * strabismic, refractive (anisometropic), isometropic or mixed mechanism amblyopia * strabismic amblyopia is defined as amblyopia (1) in the presence of either an inability to maintain parallel visual axes (heterotropia) at distance or near fixation or both, or a history of strabismus surgery (or botulinum injection), and (2) in the absence of refractive error meeting the criteria below for mixed mechanism amblyopia * refractive/anisometropic amblyopia is defined as amblyopia in the presence of a difference in refractive error between the two eyes (anisometropia) of ≥0.5 diopter (d) of spherical equivalent or ≥1.5d of difference in astigmatism in any meridian, with no measurable heterophoria at distance or near fixation, which persisted after 12 weeks of spectacle correction * isometropic amblyopia is defined as amblyopia in the presence a refractive error ≥5.0d of spherical equivalent in both eyes, but not meeting the criteria of anisometropic amblyopia * mixed mechanism strabismic and refractive amblyopia is defined as the presence of both strabismic and anisometropic types of amblyopia * ability to read the etdrs letter chart * visual acuity between 0.3 and 1.3 logmar (i.e., between 20/40 and 20/400) in the amblyopic eye * visual acuity of 0.3 logmar (i.e., 20/40) or better in the sound eye * interocular acuity difference ≥0.3 logmar * appropriate refractive error correction for at least 12 weeks exclusion criteria: * presence of an ocular cause of reduced visual acuity * myopia with a spherical equivalent of -6.0d or more, due to the likely presence of pathological myopia * prior intraocular surgery * known skin reaction to patch or bandage adhesive

Keywords: amblyopia telescopic magnification patching
emla cream as analgesic for outpatient gynecological procedures

Conditions: Pain

Summary: the goal of this clinical trial is to compare pain perception in the study participant population undergoing the following gynecological procedures: intra uterine device (iud) insertion, hysteroscopy, and endometrial biopsy and given either eutectic mixture of local anesthetics (emla) cream or a placebo. the main question to answer is: • does emla cream reduce pain when administered during the following gynecological procedures: iud insertion, hysteroscopy, and endometrial biopsy? participants will be asked to do assess their pain on the visual analogue scale through 3 times during the procedure. researchers will compare the study group with those receiving placebo group to see if there is a difference in pain scores.

gynecologic outpatient procedures such as intra-uterine device (iud) insertion, hysteroscopy and endometrial biopsies (emb) have no standard of care for pain management. this has resulted in acute pain for patients. one local anesthetic, eutectic mixture of local anesthetics (emla) cream (lidocaine 2.5%/prilocaine 2.5%), has shown to decrease perceived pain during hysteroscopy and iud placement when compared to a placebo. the purpose of this study is to evaluate whether emla cream reduces pain during the following outpatient procedures: emb, hysteroscopy, and iud placement. through a randomized control double-blind trial, study participants will have either 5 grams of emla cream or 5 grams of placebo applied to their cervix 7 minutes prior to the procedure. patients' intensity of pain will be assessed using the visual analogue scale (vas) immediately after speculum placement, during the procedure, and immediately after completion of the procedure. pain scores will be compared between the study and placebo group.

Eligibility criteria:
inclusion criteria: * patient will undergo one of the following procedures: intra-uterine device insertion, hysteroscopy, or endometrial biopsies exclusion criteria: * known hypersensitivity to amide anesthetics * pre-existing methemoglobinemia

Keywords: intra-uterine device insertion hysteroscopy endometrial biopsy
4-aminopyridine, atenolol, or placebo in patients with vestibular migraine

Conditions: Vestibular Migraine; Migraine Disorders; Vestibular Diseases

Summary: this phase 2 randomized study will be used to test the efficacy of 4-aminopyridine (4ap) or atenolol to reduce severity and frequency of vestibular and headache symptoms of vestibular migriane sufferers. blinded study drug will be taken by mouth twice a day for 14 weeks on study.


Eligibility criteria:
inclusion criteria: * severe vestibular migraine (vm) exclusion criteria: * neurologic or otologic disease other than vm * psychiatric illness requiring medication * medical illness including cancer, coronary artery or cerebrovascular disease * known allergy to one of the test medications * contraindication to use of one of the test medications - asthma, symptomatic hypotension, history of seizures * taking migraine prophylactic medication or vestibular suppressants. * pregnant or breast feeding women
a clinical study evaluating the safety and efficacy of skg0201 injection in patients with spinal muscular atrophy type 1

Conditions: Spinal Muscular Atrophy 1

Summary: this is a clinical study to evaluate the safety and efficacy of gene therapy drug skg0201 injection in patients with spinal muscular atrophy type 1 (sma 1).

this is a multicenter, open, dose-escalation clinical study to evaluate the safety, initial efficacy, and immunogenicity of skg0201 injection in patients with spinal muscular atrophy type 1 (sma 1).

Eligibility criteria:
inclusion criteria: 1. type 1 sma, defined by bi-allelic mutations in the smn1 gene. 2. age 180 days or younger at day of infusion. 3. clinical history and signs are consistent with type i sma, that is hypotonia on clinical examination, with delay in motor skills, poor head control, rounded shoulder posture, and joint hypermobility. 4. the legal guardian of the subject understands the purpose of the study, the possible risks and rights of the study, agrees that the subject can participate in the study, complete all research steps, tests and visits, and sign the icf voluntarily. 5. during the study period, according to the change of the subject's condition, the subject's legal guardian is willing to perform standard treatment requirements as suggested by the researcher. exclusion criteria: 1. pulse oximetry \< 96% saturation at screening while the patient is awake or asleep without any supplemental oxygen or respiratory support. 2. weight-for-age below the 3rd percentile for the same sex and age based on who child growth standards (who 2006). 3. active viral infection with significant signs or symptoms and require systematic hospitalization. 4. in the presence of other severe infections or diseases. 5. known allergy to prednisolone, other glucocorticoids, or their excipients. 6. clinically significant abnormal laboratory values prior to administration. 7. previously used other sma drugs (such as spinraza, evrysdi, zolgensma, etc.) or participated in clinical studies of other sma drugs. 8. had received previous or anticipated major surgical procedures during the study assessment period.

Keywords: sma 1
pd-1 antibody shr-1210 combined with apatinib of first-line treatment of advanced acral melanoma

Conditions: Melanoma

Summary: the investigators launched this exploratory study to evaluate the objective response rate (orr) of shr-1210 combined with apatinib mesylate in the first-line treatment of patients with advanced acral melanoma.


Eligibility criteria:
inclusion criteria: 1. age:18-75 years, male or female. 2. histopathologically confirmed recurrence, inoperable resection or metastatic acral melanoma (stage iii/iv). 3. has not received any systematic anti-tumor drug treatment. 4. measurable disease based on response evaluation criteria in solid tumors (recist) 1.1. 5. ecog 0-1. 6. adequate organ function. 7. life expectancy of greater than 12 weeks. 8. patient has given written informed consent. exclusion criteria: 1. patients who have or are currently undergoing additional chemotherapy, radiation therapy, targeted therapy or immunotherapy. 2. known history of hypersensitivity to macromolecular protein preparation or any components of the shr- 1210 formulation. 3. subjects before or at the same time with other malignant tumors (except which has cured skin basal cell carcinoma and cervical carcinoma in situ); 4. subjects with any active autoimmune disease or history of autoimmune disease 5. uncontrolled clinically significant heart disease, including but not limited to the following: (1) \> nyha ii congestive heart failure; (2) unstable angina, (3) myocardial infarction within the past 1 year; (4) clinically significant supraventricular arrhythmia or ventricular arrhythmia requirement for treatment or intervention; 6. active infection or an unexplained fever \> 38.5°c during screening or before the first scheduled day of dosing (subjects with tumor fever may be enrolled at the discretion of the investigator); 7. received a live vaccine within 4 weeks of the first dose of study medication. 8. pregnancy or breast feeding. 9. decision of unsuitableness by principal investigator or physician-in charge.
rl-mpv followed by bbc hct using autologous stem cells and maintenance therapy with nivolumab for newly diagnosed pcnsl

Conditions: Primary CNS Lymphoma

Summary: the purpose of this study is to determine the efficacy and safety of the new treatment proposed in this study. conducting a prospective study "cns-2015" in patients with pdlbcl cns made it possible to achieve 2-year efs, dfs and os of 83%, 83% and 88%, respectively. the presence of early relapses of the disease has now led to the need to find an alternative program for patients with pdlbcl cns. in the new "cns-2021" protocol, lenalidomide was included in the r-mpv program in order to intensify the induction stage. in the conditioning regimen, thiotepa was replaced by carmustine, due to its significant cns bioavailability. in order to possibly prevent early relapses, an anti-pd-1 inhibitor (nivolumab) was used as maintenance therapy.

patients will receive 4 cycles of rl-mpv (rituximab, methotrexate (mtx), procarbazine, vincristine, and lenalidomide (rl-mpv) as induction. the conditioning regimen prior to autologous blood stem cell transplantation includes high doses busulfan, thiotepa, and cyclophosphamide. after 3 months after autologous blood stem cell transplantation, maintenance therapy with nivolumab 3 mg/kg every 2 weeks for 6 months will be started.patients will be out of the study at the time of death. all patients believe in the possibility of survival within 3 months throughout their lives. survival status can be obtained by phone call, storage visit, or medical records (eg doctor's note/lab results from a clinic or storage visit).

Eligibility criteria:
inclusion criteria: all patients must have non-hodgkin's lymphoma involving the brain, as demonstrated by ct or mri and histologic confirmation by one of the following: a positive csf cytology for lymphoma or a monoclonal lymphocyte population as defined by cell surface markers. a biopsy of the vitreous or uvea demonstrating non-hodgkin's lymphoma. brain biopsy. patients must be hiv-1 negative. patient must have left ventricular ejection fraction ≥ 50%. patients must have no evidence of systemic lymphoma. this must be demonstrated by a ct scan of the chest, abdomen and pelvis prior to registration. patients must have adequate bone marrow function (defined as peripheral leucocyte count \>3000 cells/mm3 and platelet count \> 100,000 cells/mm3), liver function (bilirubin \ 50cc/min/1.73m2). men and women of reproductive potential must agree to use an acceptable method of birth control during treatment and for six months after completion of treatment. patients must be between 18 and 70years-old. patients must sign an informed consent. exclusion criteria: prior cranial irradiation other active primary malignancy. pre-existing immunodeficiency such as renal transplant recipient. prior treatment with chemotherapy for cns lymphoma.
long-term cognitive, neuropsychiatric and functional outcomes in adults who have received chimeric antigen-receptor t-cell (car-t) therapy for aggressive lymphoma at stanford

Conditions: Non Hodgkin Lymphoma

Summary: this study aims to assess the feasibility of performing neuropsychological testing to measure the cognitive performance of individuals following axicabtagene ciloleucel car-t therapy at stanford.


Eligibility criteria:
inclusion criteria: * \>/= 18 years-old * treated with axicabtagene ciloleucel car-t therapy at stanford or * treated with standard commercial axicabtagene ciloleucel car-t therapy elsewhere and followed primarily by shc blood and bone marrow transplant providers * \>/= 6 months from the date of car-t infusion * fluent in english * able to attend and participate in in-person testing (arm i) * able to participate in remote video testing with adequate workspace, computer and internet capabilities for a reliable telehealth video connection (arm ii) exclusion criteria: * concurrent enrollment in a car-t therapeutics research study * unable to be present for the scheduled testing * unable to participate in testing due to severe cognitive or physical limitation * actively receiving chemotherapy * progressive cancer