Kornimate/medical-research-clean huggingface dataset:
study of efficacy, safety, tolerability and pharmacokinetics of mij821 in participants with treatment- resistant depression (trd)

Conditions: Treatment-Resistant Depression

Summary: the main purpose of this study was to evaluate safety and efficacy of a single injection of mij821 in addition to standard of care (soc) pharmacological anti-depressant treatment in participants with treatment-resistant depression (trd)

the trial included a screening period of up to 28 days. on day 1, after screening, eligible participants were randomized to one of the treatment arms (1 mg, 4 mg, or 10 mg of mij821) or placebo and received study treatment administered as a single subcutaneous injection. participants remained at the clinic for at least 4 hours after administration of study treatment for safety observation including assessment of local tolerability by visual inspection of the injection area. post-dose clinic visits occurred 24 hours post dose (day 2), days 8, 15, 22 and 29 to evaluate efficacy and safety. efficacy assessments included the montgomery-asberg depression scale (madrs) and other clinical outcome assessments (coas). safety assessments included laboratory tests, ecgs, vital signs and physical examinations. in addition, phone calls were conducted 3 days after each on-site clinic visit with the exception of the end-of-study (eos) visit. eos visit was completed on site on day 29. including screening, participants were in the study for up to 8 weeks (57 days).

Eligibility criteria:
inclusion criteria: * signed informed consent obtained prior to participation in the study * male and female participants, 18 to 65 years of age (inclusive) at screening * dsm-5 defined major depressive disorder (mdd) and a current major depressive episode (mde) * madrs score ≥ 24 * failure to respond to 2 or more antidepressant treatments where the two failed treatments are two different antidepressants exclusion criteria: * any prior or current diagnosis of mdd with psychotic features, bipolar disorder, schizophrenia, or schizoaffective disorder * participants with acute alcohol or substance use disorder or withdrawal symptoms requiring detoxification, or participants who went through detoxification treatment within 1 month before screening * participants with current borderline personality disorder or antisocial personality disorder * current clinical diagnosis of autism, dementia, or intellectual disability

Keywords: treatment-resistant depression major depressive episode major depressive disorder mij821 anti-depressive agent subcutaneous placebo adult
manual compression and stretching for the myofascial trigger points in upper trapezius and levator scapulae

Conditions: Myofascial Trigger Point Pain

Summary: to compare the effectiveness of manual compression and stretching for myofascial trigger points in upper trapezius and levator scapulae in male office workers


Eligibility criteria:
inclusion criteria: * male office workers with age of 25-45 working from monday to friday for 6-8 hours in a day. exclusion criteria: * male office workers having any past trauma, chronic illness, any recent surgery and systemic diseases.
fluorescence detection of adult primary central nervous system tumors with tozuleristide and the canvas system

Conditions: Central Nervous System Tumor

Summary: the purpose of this study is to examine the use of a single dose of tozuleristide (24 or 36 mg) and the canvas imaging system during surgical resection of primary central nervous system (cns) tumors: primary gadolinium enhancing (high grade) cns tumors, primary non-gadolinium enhancing cns tumors, and primary vestibular schwannoma. the primary objectives of the study is to see how well tozuleristide and the canvas imaging system during surgical resection will show fluorescence among primary enhancing/high grade cns tumors; and among the tumors that demonstrate tozuleristide fluorescence, to estimate the true positive rate and true negative rate of fluorescence in tissue biopsies, as well as sensitivity and specificity of tozuleristide fluorescence for distinguishing tumor from non-tumoral tissue. the secondary objectives of the study include evaluating the safety of tozuleristide and the canvas imaging system, and to determine if the presence of remaining fluorescence at the time of surgery corresponds to remaining tumor evident on post-operative mri images, or if the absence of fluorescence corresponds to evidence of no gross residual tumor on post-operative magnetic resonance imaging (mri).


Eligibility criteria:
inclusion criteria: * mri obtained within 30 days of study enrollment documents a measurable lesion consistent with a primary malignant central nervous system tumor for which maximal safe resection is indicated or mri obtained within 30 days of study enrollment documents a measurable lesion consistent with a primary schwannoma enhancing tumor in the cerebellopontine angle for which maximal safe resection is indicated. * adequate renal and liver function * subjects with prior therapy are eligible provided they have recovered from any acute toxic effects of prior therapy and have sufficient time interval prior to enrollment. exclusion criteria: * pregnant, breast-feeding, or planning to conceive a child within 30 days * ongoing serious medical conditions such that participation in the study could put the subject at increased risk of worsening their condition * subjects planned to undergo only a diagnostic biopsy procedure, without intent to resect tissue for therapeutic purposes * subjects for whom radiographic evidence suggests a non-intra-axial primary brain tumor

Keywords: neurosurgery brain tumor spinal cord tumor surgical resection glioma astrocytoma glioblastoma ependymoma medulloblastoma pineocytoma meningioma germ cell tumor craniopharyngioma oligoastrocytoma pineoblastoma extent of resection maximal safe resection neuropathology vestibular schwannomas
topical aminolevulinic acid in patients with nonmelanoma skin cancer

Conditions: Non-melanomatous Skin Cancer

Summary: rationale: studying samples of tumor tissue in the laboratory from patients with nonmelanoma skin cancer that has been treated with topical aminolevulinic acid may help doctors predict how patients will respond to photodynamic therapy. purpose: this clinical trial is studying topical aminolevulinic acid in patients with nonmelanoma skin cancer.

objectives: * to evaluate the distribution and depth of protoporphyrin ix (ppix) within different types of nonmelanoma skin cancers after topical aminolevulinic acid (ala) administration. * to obtain in vivo measurements of ala-induced ppix formation within different zones of the tumors as measured by fluorescence detection methods. * to correlate the level of ppix fluorescence detected by non-invasive optical measurements with morphological characteristics of the tumors. * to establish a skin cancer tissue bank. outline: topical aminolevulinic acid (ala) is applied to the center of the tumor surface. patients then undergo punch tumor biopsy of the area where the ala is applied followed by surgery to remove the tumor. tissue samples are assessed for protoporphyrin (ppix) levels by fluorescence confocal microscopy and hyperspectral imaging. excess tumor tissue may be stored in a skin cancer tissue bank. surface measurements (from a total of 5 surface sites) of ppix fluorescence are taken at baseline and at 2 hours after ala application using an optical fiber-based hand-held dosimeter.

Eligibility criteria:
disease characteristics: * must have at least 1 biopsy-proven nonmelanoma skin cancer with a minimum diameter of 4 mm * no tumors located on the eyelids, distal nose, cartilaginous portions of the ears, or lips patient characteristics: * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception * no known hypersensitivity to aminolevulinic acid or any component of this medication prior concurrent therapy: * concurrent immunosuppressive or chemotherapeutic medications allowed * concurrent corticosteroids (taken by mouth or large doses taken with an inhaler) allowed * concurrent systemic retinoids (e.g., isotretinoin, acitretin, bexarotene, alitretinoin) or vitamin a allowed * other concurrent medications that may affect epidermal growth and differentiation (e.g., anti-egfr monoclonal antibodies) allowed * no concurrent participation in another clinical trial * no concurrent topical treatment for the target tumor or for other nonmelanoma skin cancers * no concurrent medical therapy or radiotherapy for other cancers

Keywords: basal cell carcinoma of the skin squamous cell carcinoma of the skin recurrent skin cancer
safety and efficacy of fetoscopes used in fetoscopic selective laser photocoagulation

Conditions: Twin Monochorionic Diamniotic Placenta

Summary: the purpose of this study is to evaluate the safety and efficacy of the investigational fetoscopes used in patients undergoing fetoscopic selective laser photocoagulation for complicated monochorionic-diamniotic pregnancies.

all patients who choose to undergo fetoscopic selective laser photocoagulation (s-plc) at texas children's fetal center will be offered participation in this research study by study investigators. description of study rationale and design and a focused interview by the study coordinator to afford potential participants a formal opportunity to examine what they have learned about the research study in the course of their evaluation and discuss how they feel about enrolling in the research study. once the patient is deemed eligible the informed consent process will be reviewed. if patients elect to participate in the study, informed consent will be obtained, and patients provided a copy of the signed consent. fetoscopic procedure: selective laser photocoagulation (s-plc) is standard of care for the treatment of complicated monochorionic twin pregnancies and will be performed with the same technique in this study as it is with the use of the currently approved fetoscopes. in the majority of cases, in utero access has been achieved using a small percutaneous incision under ultrasound guidance with the instruments inserted through the maternal abdomen, uterine wall and into the recipient fetus' gestational sac. the fetoscope is then used to "map" the placental vascular pattern. communicating vessels between the fetuses are ablated using laser energy via a 400-600 micron laser fiber that has been introduced through the instrument channel of the operating sheath. intravenous sedation with local anesthesia at the site of insertion has been found to provide sufficient maternal anesthesia for the procedure. at the completion of the s-plc, the excess amniotic fluid in the recipient twin's sac is removed to achieve a normal volume. follow-up: the investigators will follow patients for the immediate post-procedure period (until they leave the or).

Eligibility criteria:
inclusion criteria: * patients who are eligible and elect to undergo fetoscopic selective laser photocoagulation for the treatment of complicated monochorionic-diamniotic pregnancies. exclusion criteria: * patients who do not elect to undergo fetoscopic laser photocoagulation for treatment of complicated monochorionic-diamniotic pregnancies.

Keywords: twin-twin transfusion syndrome ttts twin anemia polycythemia sequence taps selective intrauterine growth restriction siugr
meditation and emotional intelligence

Conditions: Job Stress; Perceived Stress

Summary: this randomized controlled trial evaluated the impact of the transcendental meditation program on emotional intelligence and perceived stress in supervisors and administrative staff in a public school system

the objective of this study was to determine whether a mind-body technique, known as the practice of transcendental meditation® (tm), could significantly increase emotional intelligence and decrease perceived stress in supervisors and administrative staff in a public school system. for this purpose, 96 participants from the administrative offices of the san francisco unified school district were randomly assigned to either immediate start of the tm program or to a delayed start wait-list control group. subjects learning tm were instructed to meditate for 20 minutes twice a day for the four month duration of the project. all subjects were administered the baron emotional quotient inventory (eq-i) and perceived stress scale (pss) at baseline and posttest. if successful, these findings would suggest that tm could be used as a professional development program in organizations to increase emotional intelligence and decrease perceived stress, in turn enhancing leadership capacity and organizational effectiveness.

Eligibility criteria:
inclusion criteria: * 18 years or older, * an employee of the san francisco unified school district (sfusd), * attendance at an informational meeting on the tm program, * willingness to be randomly assigned to either active treatment or the control group. exclusion criteria: * having already learned the tm program, * not being available to attend treatment or testing sessions.

Keywords: perceived stress leadership transcendental meditation
an open-label study of azetukalner in major depressive disorder

Conditions: Major Depressive Disorder

Summary: x-nova-ole is a multicenter, open-label study to evaluate the long-term safety, tolerability, and efficacy of azetukalner as a monotherapy in adult participants who successfully completed an antecedent phase 3 study of azetukalner in major depressive disorder (mdd).


Eligibility criteria:
inclusion criteria: * participant successfully completed the treatment period of an antecedent azetukalner phase 3 study in mdd. * participant provides written informed consent to participate in the study, is able to understand the procedures and study requirements, and agrees to abide by them. * participant is willing to comply with the contraception requirements. * male participants must agree not to donate sperm until 3 months after the last dose of study drug. female participants must agree not to donate ova until 3 months after the last dose of study drug. exclusion criteria: * participant met any of the withdrawal criteria, or discontinued study drug early, or was terminated early from an antecedent study. * participant had any protocol deviations in an antecedent azetukalner study that, in the opinion of the investigator, would preclude participation in this study. * participant is unable to comply with study procedures or is inappropriate for the study, as judged by the investigator. * participant has any medical condition, personal circumstance, or ongoing ae (from an antecedent study) that, in the opinion of the investigator, exposes the participant to unacceptable risk by participating in the study or prevents adherence to the protocol. * female participant who is pregnant, breastfeeding, or planning to become pregnant within 3 months after the last dose of study drug. * participant is planning to enter a clinical study with a different investigational drug or planning to use any experimental device for treatment of any medical condition during the study or within 28 days after completion of this study. * participant is judged to have a significant risk for self-harm or suicidal behavior or is considered to be an imminent danger to themself or others, as determined by the c-ssrs or in the opinion of the investigator.

Keywords: depression antidepressant xen1101 azetukalner
ocrelizumab in breastmilk

Conditions: Multiple Sclerosis; Clinically Isolated Syndrome

Summary: the goal of the current project is to measure the levels of ocrelizumab in the breastmilk of women with multiple sclerosis (ms) and clinically isolated syndrome (cis) who are postpartum, and to collect information on 12-month infant development outcomes (length, weight, head circumference, infections) in their offspring. this study will fill a significant unmet need as many women with ms at high risk for postpartum relapses are not effectively treated for their ms in the postpartum period due to lack of information about the presence, concentration and effects of medications in breastmilk.

levels of ocrelizumab in breastmilk will be serially evaluated across one drug half-life from women with ms and cis who are postpartum and lactating at the time of the infusion (whether or not they plan to continue to breastfeed their baby after the infusion). the timeline for breastmilk sample is dependent on infusion schedule and dosing if receiving 600mg infusion x1, collection will occur: before infusion and at 8h, 24h, 7d, 20d, 30d, 60d, and 90d post infusion; if receiving 300mg infusion x2 collection will occur: before infusion 1, at 8h, 24h, 7d, and 14d (before infusion 2) after infusion 1 and after infusion 2 at 8h, 24h, 7d, 20d, 30d, 60d, and 90d in 20. blood samples to determine serum concentration of ocrelizumab will be collected, when possible, at the 24-hour, 14 day (if receiving 300mg infusion x2), and 20d timepoint(s). both women continuing to breastfeed their infant post-infusion and those that chose to discontinue will be included in the study. in order to ensure broad collaboration as well as rapid recruitment, samples will be collected from patients fitting eligibility criteria upon referral to our study by other investigators.

Eligibility criteria:
inclusion criteria: * women between the ages of 18 and 64 that carry a diagnosis of clinically isolated syndrome or multiple sclerosis (based on the 2010 mcdonald criteria). * participants must be pregnant, contemplating pregnancy or postpartum at the time of enrollment. * participants must be receiving treatment with ocrelizumab infusion between 2 and 36 weeks postpartum (300mg x2 or 600mg x1). * participants must be willing to provide breastmilk samples before and after their first and, if applicable, second ocrelizumab infusions postpartum. * a signed informed consent and hipaa authorization form is required for participation. exclusion criteria: * patients unable to provide informed consent. * patients unable or unwilling to provide breast milk samples for analysis.
a study to learn about dacomitinib in patients with non-small cell lung cancer.

Conditions: Lung Cancer

Summary: the purpose of this study is to learn about dacomitinib for the possible treatment of lung cancer. this study is seeking participants who: * have lung cancer that could not be controlled. * have a type of gene called epidermoid growth factor receptor. a gene is a part of your dna that has instructions for making things your body needs to work. * have received dacomitinib for their lung cancer. all participants in this study had received dacomitinib. dacomitinib is a tablet that is taken by mouth at home. they continued to take dacomitnib until their cancer was no longer responding. the study will look at the experiences of people receiving the study medicine. this will help to see if the study medicine is safe and effective.


Eligibility criteria:
inclusion criteria: * evidence of histologically or cytologically confirmed diagnosis of advanced nsclc with egfr-activating mutations detected by an appropriate test * patients who were treated with dacomitinib as first-line treatment for advanced nsclc during 01 october 2020 to 31 december 2022. * age ≥18 years old * evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study. exclusion criteria: * patients who have been treated with any systemic anti-cancer therapies within 12 months prior to dacomitinib treatment.

Keywords: egfr nsclc brain cns dacomitinib
study in an ex-vivo thrombosis model with human umbilical vein endothelial cells (huvec)-perfusion

Conditions: Thrombosis; Thrombus Formation; Thrombus Stability

Summary: evaluation of fibrin and platelet deposition on a human umbilical endothelial cell surface in perfusion chamber experiments using human whole blood. open-label, non interventional study perfusion chamber experiment will be performed in 30 healthy patients. the impact of different ph-solutions on thrombus lysis will be evaluated in an in-vitro second step outcome: d-dimer content of the thrombus reflecting the size of the thrombus.

all subjects will have two perfusion chamber experiment as follow with an estimated maximum of blood loss of 165ml: before blood perfusion, perfuse the system including the chambers with human umbilical vein endothelial cell coated glass slides (huvec), with sodium chloride (nacl) (0.9%), to ensure no leaks and to remove all air bubbles. blood is drawn from a vein in the arm with a surflo® winged infusion set, 19g (terumo europe, leuven, belgium) with a pump (masterflex® l/s™, cole-parmer instrument company, vernon hills, illinois, usa). five ml of blood is discarded before each perfusion. three in serial placed flow chambers (with huvec) heated to 37°c are used. they are made of a plexiglas block through which a cylindrical hole of 0.2 cm in diameter is machined. the aorta pieces are perfused at 10 ml/min for 5 minutes, followed by a 30 seconds perfusion with nacl (0.9%). the plasmin degraded thrombus d-dimer content will be further evaluated under different conditions (different ph solutions).

Eligibility criteria:
inclusion criteria: * age \> 18 years * written informed consent exclusion criteria: * use of any medication * current diseases * anemia

Keywords: perfusion chamber thrombus d-dimer huvec
nonopioid pain control regimen after arthroscopic hip procedures

Conditions: Hip Arthroscopy

Summary: this study is being conducted to evaluate the effectiveness of post-operative pain control without using narcotic pain medications.


Eligibility criteria:
inclusion criteria: • scheduled for a primary hip arthroscopy at mayo clinic (rochester, mn) exclusion criteria: * medical history of known allergies or intolerance to allergies or intolerance to motrin, gabapentin, tylenol, dexamethasone, tramadol, or robaxin. * substantial alcohol or drug abuse. * history of narcotics within 6 months of surgery. * pregnancy. * renal impairment. * peptic ulcer disease. * gi bleeding.
12 / 48 week pivotal pft vs pbo in copd i

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: this primary objective of this study is to compare two doses of bi 1744 cl inhalation solution delivered by the respimat® inhaler once daily to placebo in patients with chronic obstructive pulmonary disease (copd). the safety of bi 1744 cl inhalation solution delivered through the respimat inhaler will also be compared to placebo.


Eligibility criteria:
inclusion criteria: * all patients must have a diagnosis of chronic obstructive pulmonary disease * male or female patients, 40 years of age or older patients must be current or ex-smokers with a smoking history of more than 10 pack years post bronchodilator fev1 \<80% predicted and post-bronchodilator fev1/fvc \<70% exclusion criteria: * patients with a significant disease other than copd * patients with a history of asthma * patients with any of the following conditions: a history of myocardial infarction within 1 year of screening visit (visit 1) unstable or life-threatening cardiac arrhythmia. have been hospitalized for heart failure within the past year. known active tuberculosis a malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years (patients with treated basal cell carcinoma are allowed) a history of life-threatening pulmonary obstruction a history of cystic fibrosis