Kornimate/medical-research-clean huggingface dataset:
amlodipine plus botulinum toxin for focal dystonia

Conditions: Focal Dystonia

Summary: objective: to determine if the calcium channel blockers, amlodipine can augment the effect of botulinum toxin injections in the treatment of focal dystonia. study population: 20 patients with cervical dystonia design: double-bind, placebo-controlled clinical trail. outcome measures: for patients: dystonia rating scales (twistrs, fahn-marsden dystonia scale, ninds subjective patient rating scale), and hand grip strength. for healthy volunteers: amplitude of edb mep.

objective: to determine if the calcium channel blocker, amlodipine can augment the effect of botulinum toxin injections in the treatment of focal dystonia. study population: 20 patients with cervical dystonia design: double-bind, placebo-controlled clinical trail. outcome measures: dystonia rating scales (twistrs)

Eligibility criteria:
* inclusion criteria: patients enrolled in protocol 85-n-0195, efficacy and pathophysiology of botulinum toxin for treatment of involuntary movement disorders are eligible for enrollment if they meet the following inclusion and exclusion criteria. good general health focal hand dystonia or cervical dystonia stable response to botulinum toxin demonstrated through a series of at least 3 injections over a period of at least a year benefit from the 3 immediately prior btx injections rated as 75% or less or a duration of benefit lasting less than or equal to 2 months no other medications for dystonia exclusion criteria: cervical dystonia accompanied by dysphagia or dyspnea, either before or with botulinum toxin injection present or past cardiac disease, hypertension, arrhythmia or congestive heart failure anterocollis or other neck dystonia requiring bilateral anterior neck muscle injections use of concomitant medications affecting calcium channels or those metabolized by the cytochrome p450 3a4 system including grapefruit juice, st. john's wort, hiv protease inhibitors, cimetidine, antibiotics (macrolides, fluoroquinones, antifungal, rifampin), antidepressants (fluvoxamine, norfluoxetine), barbiturates, anticonvulsants (carbamazepine, phenytoin), oral diabetes agents (pioglitazone, troglitazone), and glucocorticoids allergy to amlodipine or related compounds pregnany/ nursing age less than 18 years of age abnormal ekg abnormal coagulation profile or liver function tests use of anticoagulants

Keywords: writer's cramp calcium channel antagonists torticollis chemodenervation
immunogenicity and safety study of monovalent omicron xbb.1.5 vaccine as a booster in adults

Conditions: COVID-19

Summary: the purpose of this study is to assess the immunogenicity and safety of scb-2023b monovalent omicron xbb.1.5 vaccine compared to the prototype scb-2019 vaccine in participants previously vaccinated with 3 doses of inactivated covid-19 vaccine ≥6 months prior to enrollment.

the purpose of this study is to assess the immunogenicity and safety of scb-2023b monovalent omicron xbb.1.5 vaccine compared to the prototype scb-2019 vaccine in participants previously vaccinated with 3 doses of inactivated covid-19 vaccine ≥6 months prior to enrollment.

Eligibility criteria:
inclusion criteria: * male or female ≥18 years of age. * individuals willing and able to comply with study requirements, including all scheduled visits, vaccinations, laboratory tests and other study procedures. * individuals willing and able to give an informed consent, prior to screening. * healthy participants or participants with pre-existing medical conditions who are in a stable medical condition. * individuals who received three doses of inactivated covid-19 vaccine exclusion criteria: * body temperature \>37.8°c (axillary), or any acute illness at baseline. * confirmed sars-cov-2 infectionor with known history of covid-19. * individuals who have received an investigational or licensed covid-19 vaccine prior to day 1 (except for inactivated covid-19 vaccine). * any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy. * any progressive unstable or uncontrolled clinical conditions. * individuals who are pregnant, or breastfeeding, or planning to become pregnant while enrolled in this study or during the study period. * history of severe adverse reaction associated with a vaccine or severe allergic reaction. * history of malignancy within 1 year before screening. * individuals who have received any other investigational product. * individuals who have received any other licensed vaccines within 14 days prior to enrollment. * treatment with rituximab or any other anti-cd20 monoclonal antibodies. * known bleeding disorder that would, in the opinion of the investigator, contraindicate i.m. injection. * administration of intravenous immunoglobulins and/or any blood products. * any condition that, in the opinion of the investigator, would interfere with the primary study objectives or pose additional risk to the participant.
analysis of three-dimensional movements of the head in cervical dystonia

Conditions: Cervical Dystonia

Summary: this study addresses postures and range of motion in cervical dystonia (spasmodic torticollis). it uses 3d miniature and wireless motion captures sensors, and aims to increase the understanding of the biomechanics of the movement disorders of the cervical column in this pathology. in addition, the clinical state of cervical dystonia of the patients will be assessed, using the toronto western spasmodic torticollis rating scale (twstrs). the investigators will compare the results between control and study groups.


Eligibility criteria:
inclusion criteria: * segmental cervical dystonia diagnosed by a neurological specialist in movement disorders exclusion criteria: * neurological pathology other than cervical dystonia such as parkinson's disease, head tremor, severe pain or cervical ailment, which would have required a treatment within the last six months * neuroleptic treatment in course * pregnancy * breast feeding
the impact of focused transthoracic echocardiography in urgent abdominal surgery for septic patients

Conditions: Sepsis; Hypovolemia; Peritonitis

Summary: the aim of the study is to identify the diagnostic value of the focused assessed echocardiography in septic patients undergoing urgent abdominal surgery due to peritonitis. the investigators expect that the incidence of hemodynamic instability will be reduced and the survival of the patients will be improved.

often sepsis remains undiagnosed at the very beginning because of the concentration to the surgical pathology in perioperative period. this results in unacceptably high mortality. the investigators hypothesize that extended hemodynamic monitoring by focused transthoracic echocardiography will personalize early fluid resuscitation which will improve patient's outcome. the goals of the investigators study are: * to conduct two-group randomized controlled clinical trial to compare patient management based on standard monitoring and extended hemodynamic monitoring by focused transthoracic echocardiography in patients undergoing urgent abdominal surgery due to peritonitis. * to demonstrate that patient management based on extended hemodynamic monitoring by focused echocardiography results in improved survival, reduced incidence of hemodynamic instability during perioperative period. * to compare an amount of administrated of intravenous fluids in both groups. the investigators hypothesize that focused echocardiography monitoring will result in more administrated intravenous fluids during perioperative period.

Eligibility criteria:
inclusion criteria: * age more than 18 years old. * patients undergoing urgent abdominal surgery due to diffuse peritonitis. * sofa score \>2. * patients who sign an agreement to participate in the study. exclusion criteria: * younger than 18 years old. * known pregnancy. * unconscious patients or those who do not agree to participate in the study. * contraindication to central venous or arterial catheterization. * patients who were already treated in icu because of sepsis or septic shock before this surgery. * known chronic renal failure. * re-laparotomy. * peritonitis due to acute mesenteric ischaemia, thrombosis or trauma. * dying patients.

Keywords: sepsis echocardiography urgent abdominal surgery
resistance exercise program on the functionality of individuals with chikungunya fever

Conditions: Chikungunya Fever

Summary: common symptoms of chikungunya fever are persistent arthritis and arthralgia, such symptoms can lead to impairment in functionality. the objective of this study is to evaluate the efficacy of a resistance exercise protocol on the functionality of individuals with chronic musculoskeletal manifestations of chikungunya fever. quality of life, number of painful joints, intensity of pain, number of recurrence of exacerbation and thermography are secondary outcomes that will also be evaluated. the protocol uses elastic resistance to strengthen muscle groups that stabilize the main joints affected by chikungunya fever. the sessions will be 2 times a week for 12 weeks. the control group will not be submitted to the intervention during the 12 weeks, being contacted through telephone calls. after the reevaluation at the end of the 12 weeks the control group will perform the same protocol. the sample will be characterized and the effect size and the mean difference will be calculated. intention-to-treat analysis and rate of adherence will also be calculated.


Eligibility criteria:
inclusion criteria: * diagnosis of chikungunya fever for more than three months * present musculoskeletal symptoms after infection (eg, arthritis or arthralgia) exclusion criteria: * cognitive deficit that compromises the understanding and accomplishment of the protocol (minimental\<24); * self-reported disease that contraindicates the performance of research procedures (eg, unstable angina); * self-reported diagnosis of neurological disease; * prior self-reported diagnosis of other inflammatory or autoimmune rheumatic diseases or fibromyalgia; * pregnancy; * physical impairment that prevents arrival to the research site or execution of the exercises (eg, use of walking devices); * execution of other physiotherapeutic treatments during the research period; * regular practice of physical exercises in other places during the period of participation in the research.
biomarkers in endometriosis

Conditions: Endometriosis

Summary: endometriosis is a common gynecological benign disease which significantly compromise quality of life in patients and is a major cofactor of infertility. with the proteomic approach the investigators will search for proteins with significantly different levels in peritoneal fluid, serum and uterine fluid samples of women with endometriosis versus control group. results will be validate using elisa aproach.

informed consent will be obtained from all individual participants included in the study. blood sample will be obtained the day before laparoscopic surgery during regular clinical preoperative procedures. peritoneal fluid and uterine fluid will be obtained during regular laparoscopic procedure indicated for infertility, the exact protocol of sample obtaining will be revealed after publication of results. the aim of the study was to identify potential diagnostic and predictive biomarkers or drug targets.

Eligibility criteria:
inclusion criteria: * primary infertility * normal semen analysis of the partner * normal bmi. exclusion criteria: * hormonal therapy in the last year, * irregular menstrual cycle, * previous pelvic surgery, * history of previous pelvic inflammatory disease, * smokers and patients with autoimmune diseases, * malignant or suspected malignant diseases, * previous pelvic inflammatory disease, leiomyoma uteri or polycystic ovaries

Keywords: endometriosis biomarkers
pediatric postoperative analgesia herniorrhaphy study

Conditions: Analgesia

Summary: this is a phase 2 study in pediatric subjects undergoing inguinal herniorrhaphy.


Eligibility criteria:
inclusion criteria: * is scheduled to undergo a unilateral open inguinal herniorrhaphy with or without mesh under general anesthesia. * has an american society of anesthesiologists physical status of i, ii, or iii. * female subjects are eligible only if not pregnant, not lactating, not planning to become pregnant during the study, sterile; or using acceptable contraceptives. exclusion criteria: * has a medical condition such that, in the opinion of the investigator, participating in the study would pose a health risk to the subject or confound the postoperative assessments. * has a planned concurrent surgical procedure (eg, bilateral herniorrhaphy). * has a contraindication or a known or suspected history of hypersensitivity or clinically significant idiosyncratic reaction to required study medications. * has taken meloxicam within least 10 days prior to the scheduled surgery. * has been administered bupivacaine within 5 days prior to the scheduled surgery. * has been administered any local anesthetic within 72 hours prior to the scheduled surgery. * has a known or suspected history of drug abuse, a positive drug screen on the day of surgery, or a recent history of alcohol abuse. note: subjects with a positive drug screen who are taking an allowed, prescribed medication that is known to result in a positive drug test (eg, amphetamine and dextroamphetamine for attention-deficit/hyperactivity disorder, benzodiazepine for anxiety disorder) may be eligible for participation in the study at the discretion of the sponsor. subjects taking any marijuana (medical or recreational) are not allowed to participate in the study. * previously participated in an htx-011 study. * received an investigational product or device in a clinical trial within 30 days or within 5 elimination half-lives. * has a body mass index (bmi) \>35 kg/m2. in addition to the preceding exclusion criteria 1 through 14, subjects to be enrolled in cohort 1 part b, cohort 2 part b, or cohort 3 who meet any of the following criteria prior to randomization will be excluded from the study: * has had a prior ipsilateral inguinal herniorrhaphy. * has a pre-existing concurrent acute or chronic painful physical/restrictive condition expected to require analgesic treatment in the postoperative period for pain. * has known or suspected daily use of opioids for 7 or more consecutive days within the previous 6 months. * has taken long-acting opioids within 3 days prior to the scheduled surgery. * has taken any opioids within 48 hours prior to the scheduled surgery. * has initiated treatment with study medications within 1 month prior to study drug administration that can impact pain control. * has been administered systemic steroids within 5 half-lives or 10 days prior to administration of study drug. * has undergone 3 or more surgeries within 12 months.

Keywords: inguinal hernia postoperative pain herniorrhaphy pediatric local anesthetic
effects of different anesthesia applications on mood, depression, and anxiety levels in burn patients

Conditions: Burn Unspecified Degree; Deep Sedation

Summary: adequate and effective pain management and prevention of depression are essential in burn patients. this study aims to investigate the effects of ketamine sedation in burn patients in terms of mood disorders, depression, anxiety, and suicidal tendency during intensive care follow-up in the postoperative period.

aim: adequate and effective pain management and prevention of depression are essential in burn patients. this study aims to investigate the effects of ketamine sedation in burn patients in terms of mood disorders, depression, anxiety, and suicidal tendency during intensive care follow-up in the postoperative period. methods: the study was conducted with 67 patients between 18 and 65 years of age, who were asa i-ii class, had basic communication skills, no previous diagnosis of psychiatric illness, and no history of neuropsychiatric or cognitive disease or related treatment. after preoxygenation, anesthesia induction was performed with 2 mg/kg iv propofol and 1 mcg/kg iv fentanyl in the general anesthesia group. anesthesia was continued with a mixture of 0.3-0.5 mcg/kg/min remifentanil, 2% sevoflurane, 50% air, 50% oxygen. in the sedation group, 1 mcg/kg iv fentanyl and 1 mg/kg iv ketamine were administered at induction; anesthesia was maintained by adding 30-50 mg iv propofol if necessary. the montgomery-asberg depression rating scale (madrs), the hamilton anxiety rating scale (ham-a), and the beck scale for suicide ideation (bssi) were administered preoperatively and on postoperative day one by the psychiatrist.

Eligibility criteria:
inclusion criteria: * who were asa i-ii class, * had basic communication skills, * no previous diagnosis of psychiatric illness, * no history of neuropsychiatric or cognitive disease or related treatment. exclusion criteria: * with a previous diagnosis of psychiatric illness, * neuropsychiatric or cognitive illness, * or a history of related treatment.

Keywords: burn patient depression ketamine suicidal tendencies
endovascular magnesium sampling in acute stroke

Conditions: Acute Stroke

Summary: this investigation will address the safety and feasibility of distal, intra-arterial sampling through endovascular access, in acute stroke patients. levels of magnesium will be measured in the region of infarct in patients who had been treated with intravenous magnesium therapy following an acute stroke. this study attempts to address whether the traditional intravenous means of neuroprotectant administration achieves adequate concentration of the therapeutic agent in the area of diseased tissue.


Eligibility criteria:
inclusion criteria: 1. patient with acute cerebral ischemia due to ica or mca occlusion, 2. patient already enrolled in the nih fast-mag clinical trial, 3. patient's clinical attending physician plans mechanical embolectomy procedure as part of routine clinical care. 4. age 40-95 inclusive (age criteria for fast-mag trial). exclusion criteria: 1. technical inability to navigate microcatheter to target clot. 2. patient or surrogate unavailable for consent

Keywords: stroke magnesium endovascular
markers of atopy in children with presumed early exposure to allergens, unhygienic conditions, and infections

Conditions: Atopic Diseases

Summary: there are many studies regarding possible causes of increasing trend in frequency of allergic diseases in the last three decades. main causes of this trend are: decrease of infectious diseases frequency, improvement in life level, changes in diet and lactic acid bacterias elimination from digestive tract. primary purpose of this study is to compare the prevalence of atopy and atopic diseases in two child populations: foster care and reference children and - to define risk and protective factors for the development of atopy.

there are many studies regarding possible causes of increasing trend in frequency of allergic diseases in the last three decades. main causes of this trend are: decrease of infectious diseases frequency, improvement in life level, changes in diet and lactic acid bacterias elimination from digestive tract. less exposition to microbes can lead to the disturbance in optimal balance between th1 and th2 lymphocytes, prevalence of th2 cytokines and excessively high production of ige. decreased exposure to microbes has resulted in the loss of main source of immune provocation, and a consequent increase in pathogenic immune responses and their associated diseases. molecular interactions between immunocytes and microbes are mediated largely by toll-like receptors (tlrs) on host cells and a diversity of ligands produced by viruses, bacteria and fungi. many studies confirm the protective role of some viral, bacterial or parasite infections against atopy development. the studied group consisted of 500 children, living in all the ten community foster homes in lodz. the reference group consisted of 500 children, living with their parents at home, recruited from primary care centres. primary purpose of this study is to compare the prevalence of atopy and atopic diseases in two child populations: foster care and reference children and - to define risk and protective factors for the development of atopy. secondary purpose is the genotyping and cytometric study - to define risk and protective factors for the development of atopy. primary outcome measures: skin prick test results with 18 allergens, peripheral blood eosinophil count, level of total and specific ige in children with positive skin-test results were secondary and point, spirometry, medical history and physical examination. secondary outcome measures: included symptoms of asthma and other allergic diseases, lung function, parental allergy only for children from reference group, family history including life conditions in very early childhood, and markers of allergy such as total ige serum concentration and eosinophil blood count, expression of tlr2, tlr4, tlr7, tlr9, examining the serum samples for specific antibodies to toxocara sp, toxoplasma gondi, ascaris lumbricoides, dna.

Eligibility criteria:
inclusion criteria: * must be able to make spirometry exclusion criteria: * pregnancy

Keywords: atopy atopic diseases children orphanages
rate of tranexamic acid administration on blood pressure (ratetxa) study.

Conditions: Healthy Participants

Summary: tranexamic acid is a well-established treatment for post-partum hemorrhage. this study aims to examine the effect of tranexamic acid administration rates on blood pressure changes over 1 minute compared to 10 minutes in healthy pregnant patients scheduled for cesarean delivery.

women who are clinically diagnosed with post-partum hemorrhage during a vaginal or cesarean delivery should be immediately administered tranexamic acid according to the world health organization's recommendation. tranexamic acid is a drug that inhibits the breakdown of fibrin clots which reduces blood loss. however, due to the risk of hypotension, the product monograph for txa advises against rapid intravenous (iv) administration. other clinical studies have also reported an increased incidence of nausea, vomiting, and visual disturbances; nonetheless, the results of these trials suggest that these side effects may be related to properties of txa rather than the rate of administration. therefore, the investigators of this study aim to determine if the rate of tranexamic acid administration has an effect on blood pressure in healthy pregnant patients who are scheduled for cesarean delivery under spinal anesthesia.

Eligibility criteria:
inclusion criteria: * pregnant patients ≥34 weeks gestational age, for elective cesarean delivery under single-shot spinal anesthesia. * american society of anesthesiologists (asa) physical status class 2. * patients ≥19 years of age. exclusion criteria: * known history of pre-existing hypertension or hypertension disorders of pregnancy. * having recently taken a medication to treat high blood pressure (e.g. labetolol, hydralazine, nifedipine) * having recently taken a medication that could alter blood pressure, which could include beta those prescribed for anxiety (e.g. propranolol) or sedative pre-medication (e.g. midazolam, lorazepam). * known allergic reaction or hypersensitivity to txa or any other txa homologue. * elective cesarean delivery requiring general anesthesia or a neuraxial technique other than a single-shot spinal (e.g. epidural or combined spinal epidural). * patients who are unable to give informed consent due to a language barrier as the study team only speaks english and will be unable to complete consent process and study procedure appropriately. * patients arriving late to the surgical day care with \<90 min prior to scheduled cesarean delivery time resulting in potential delay for the operating room or inadequate time for consent and full execution of the protocol.

Keywords: tranexamic acid infusion rate post-partum hemorrhage hypotension cesarean delivery