Kornimate/medical-research-clean huggingface dataset:
amaze™ asthma implementation qi study

Conditions: Asthma

Summary: the primary study objective is to generate evidence as to the feasibility, usability, perceived value, and potential benefits of implementing the amaze™ platform into clinical practice.

astrazeneca has developed the amaze™ disease management platform to be used across multiple disease indications to provide a unified experience for the management of patients throughout their patient care journey. amaze™ integrates multiple systems, including a patient mobile application where patients can enter daily symptoms and impact to communicate this information to their healthcare provider, as well as access disease educational materials. implementation of amaze™ within clinical practice has not yet been evaluated. the results from this study will be used to inform any changes or modifications that need to be made to the technology platform, its implementation process, and explore impact on clinical outcomes.

Eligibility criteria:
inclusion criteria: * \>18 years of age at the time of enrollment * clinically confirmed diagnosis of asthma * access to a smartphone with internet access with the following requirements: ios (operating system ios 13 or newer and devices iphone 8 or newer) or android (operating system 8.0 or newer) * able to understand and speak english sufficiently to be able to use the amaze™ patient app * willingness to participate in a telephone interview and be audio-recorded * consenting to participate in the study exclusion criteria: * current diagnosis of active chronic obstructive pulmonary disease (copd) or any pulmonary diagnosis other than asthma; * has a cognitive impairment, hearing difficulty, acute psychopathology, medical condition, or insufficient knowledge of the english language that, in the opinion of the investigator, would interfere with his or her ability to agree to participate and/or complete the act™
a safety and efficacy study of enzalutamide in indian patients with progressive metastatic castration-resistant prostate cancer (mcrpc) previously treated with docetaxel-based chemotherapy

Conditions: Metastatic Castration Resistant Prostate Cancer

Summary: the purpose of this study was to evaluate the safety and tolerability of enzalutamide in indian patients with progressive mcrpc previously treated with docetaxel-based chemotherapy. this study also evaluated the effect of enzalutamide on prostate-specific antigen (psa).


Eligibility criteria:
inclusion criteria: * subject is diagnosed with histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation, signet cell or small cell histology. * subject with established diagnosis of metastatic castration-resistant prostate carcinoma. * subject is being newly initiated on xtandi treatment (enzalutamide). * subject has an estimated life expectancy of ≥ 6 months. * subject agrees not to participate in another interventional study while participating in the present study. exclusion criteria: * subject who is not eligible to receive xtandi as per the locally approved prescribing information. * subject participating or planning to participate in any interventional drug trial during the course of this trial. * subject has received investigational study within 28 days or 5 half-lives, whichever is longer, prior to screening. * subject has any condition which makes the subject unsuitable for study participation.

Keywords: progressive metastatic castration-resistant prostate cancer (mcrpc) enzalutamide xtandi mdv3100
post-operative pain after recovery in thoracic surgery

Conditions: Neuropathic Pain; Post Operative Pain; Thoracic Surgery

Summary: persistent pain after surgery has significant physical and mental consequences for the patient, as well as a significant economic impact on health systems. neuropathic pain is caused by direct or indirect damage to the somatosensitive system. in thoracic surgery, chronic neuropathic pain is represented by post-thoracotomic pain syndrome (ptps), defined as recurrent or persistent pain in the thoracotomy scar site that persists for more than 3-6 months. currently, in literature, the prevalence of ptps is extremely variable. this prospective observational study aims to assess the incidence of pain in the weeks and months following surgery and to assess whether and how the presence of painful symptoms changes the patient's quality of life.

for each patient enrolled in the study, in the pre-operative phase, comorbidities, any chronic analgesic therapy and quality of life (through a dedicated questionnaire - euro qol 5d5l1) will be recorded. surgical data (type of procedure, lobe affected by resection, type of approach and surgical time) and anesthesiological data (intravenous opioid, locoregional technique (s), non-opioid analgesics administered and other medications) will be collected in the perioperative phase. in the 48 hours following the surgery (in the recovery room, at 6h, 12h, 24h, 36h and 48h) the patient's pain data will be recorded (static, dynamic and cough-associated nrs) and those relating to any complications. the total amount of morphine administered to the patient in the first 48 hours will also be recorded. each patient will be evaluated 7 days, 1, 3 and 6 months after the surgery by telephone interview. in this last phase, the possible presence of pain and its characteristics will be assessed, especially if these meet the criteria of neuropathic pain.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * patient's consent to the trial * candidate to resective lung surgery (lobectomy, segmentectomy, atypical resection) with minimally invasive approach (mini-thoracotomy with muscle sparing or video-assisted thoracic surgery, vats) exclusion criteria: * neurological and / or cognitive deficits * inability to obtain informed consent * surgeries that include wall resections (pleural, muscle, rib or nerve) * pneumonectomy * previous thoracic surgery at the time of enrollment

Keywords: thoracic surgery analgesia chest wall analgesia post-thoracotomic pain syndrome vats
real-world effectiveness of perinatal rsv immunoprophylaxis

Conditions: RSV Infection

Summary: the purpose of this study is to continue evaluating how well the rsv vaccines work as they are currently being used in routine clinical practice. some of the questions that the investigators hope to answer with this study are: 1) what is the overall effectiveness of these vaccines? 2) how long does immunity last? 3) how effective are the vaccines against new strains? 3) does the vaccine's effectiveness vary by age?

this will be a large-scale case-control study aiming to evaluate the effectiveness of perinatal rsv immunoprophylaxis. cases and controls will be identified using active surveillance in both inpatient and outpatient clinical sites of the yale new haven health system. investigators will enroll patients seeking health care for acute respiratory illness and confirm rsv infection using approved molecular assays. data will be collected from multiple sources, including health records, interviews, immunization registries, and population-based surveys. investigators will generate estimates of effectiveness for each type of immunization used, disaggregated by time from immunization, disease severity, and sociodemographic characteristics (aim 1). investigators will also perform genetic characterization of all rsv viruses in the study, monitor the genetic diversity of the virus over time, and quantify the relative effectiveness of immunoprophylaxis against various viral lineages (aim 2). finally, investigators will collect acute and convalescent blood from a subset of infants and employ a single-cell and multi-omics approach to study the dynamics of the innate and adaptive immune responses during rsv infection and explore the molecular mechanisms that contribute to immunoprophylaxis failure (aim 3).

Eligibility criteria:
inclusion criteria: * ≤ 12 months of age at the time of presentation for evaluation for an acute respiratory infection (ari). * documentation of an ari, which is defined as an acute onset (\<10 days) illness that includes: at least two of the following symptoms: fever (measured or subjective), chills, rigors, myalgia, headache, sore throat, nausea or vomiting, diarrhea, fatigue, congestion or any one of the following: cough, shortness of breath, difficulty breathing, olfactory disorder, taste disorder, confusion, persistent chest pain, pale, gray, hypoxia, clinical or radiographic evidence of pneumonia or respiratory distress syndrome. * residents of connecticut exclusion criteria: * illness duration of \>10 days at the time of respiratory specimen collection, measured from the date of the first symptom of the current acute illness. * parents/guardians are not able to provide informed consent to be eligible for inclusion in the study as a healthy control, an individual must meet all of the following criteria: * immunized against rsv ≤ 12 months of age * residents of connecticut * match an enrolled case that was a vaccine failure by date of birth (±1 month), sex, and immunoprophylactic agent received (i.e., maternal vaccine vs mab).
snap 25 gene study

Conditions: Attention-Deficit/Hyperactivity Disorder

Summary: to enhance our capacity to correctly choose the appropriate medication for adhd patients on the first try based on the presence of a particular variant of a gene that could be identified on a laboratory test. it is hypothesized that patients with attention deficit hyperactivity disorder (adhd) who have failed to respond to methylphenidate medication, but do respond to amphetamines, have a higher than expected incidence the allelic variants of the snap 25 gene associated with adhd, and mutations of the dopamine system genes drd1, 2, 4, 5 and dopamine transporter and comtand maoa.

previous research has demonstrated that while 75% of patients respond to any stimulant, of those who do not 33% will respond to a stimulant of the other class. based on previous research correlating increased mutations in the dopamine system genes drd1, 2, 4, 5, dopamine transporter, comt, and maoa with adhd, we will also be investigating the relationship between mutations in these genes and patient response to mph and amphetamines. this study is a pilot, but it was an obvious next step in the studies that are being done on the genetics of adhd. the outcome of this research, whether an association is or is not found, will be of considerable interest to researchers internationally, and will demonstrate the value of help funding in promoting research that can alleviate mental illness in children the study will make a significant contribution to appropriate intervention for these children, and promote greater awareness that the deficits suffered by children with attention problems is neither willful nor a matter of intelligence, but rather a syndrome that can be explained and can be modified with appropriate medical care. a chi-square test will be conducted to determine whether there is differential representation of snap 25 among therapeutic methylphenidate responders versus non-responders. statistical comparison will be performed using a two-tailed test at the .05 level of significance.

Eligibility criteria:
inclusion criteria: 1. patients will be male or female outpatients who are at least 6 years of age (there is no upper age limit) 2. patients must meet dsm-iv criteria for adhd 3. patients and parents/guardians must have a degree of understanding sufficient to be able to communicate suitably with the investigator and study coordinator 4. patients must have tolerated the drug at therapeutic doses, but have shown a true lack of improvement in symptoms 5. must have shown clinically significant superiority in improvement in adhd symptoms on amphetamine relative to mph. exclusion criteria: 1. must not have a true allergy to methylphenidate or amphetamines 2. must not have a history of serious adverse reactions to methylphenidate

Keywords: adhd snap 25 amphetamine methylphenidate
verbal instruction for contraction pelvic floor muscles among males

Conditions: Pelvic Floor Muscle Weakness

Summary: the aim of this study is to compare the effectiveness of different verbal instruction on pelvic floor muscle contraction among males. pelvic floor contraction will be measured via ultrasound.

this study will examine pelvic floor muscle contraction following six different verbal instructions among males. physical-therapy students will be recruited to complete a survey and non-invasive transabdominal ultrasound assessment. a bladder filling protocol will be implemented to ensure subjects will have sufficient fluid in their bladders to allow clear ultrasound imaging. this protocol involved subjects consuming 600-750 ml of water in a 1 hr. period. the participants will be tested in a crook-lying supine position with a pillow under their heads for comfort. all participants will be given six different verbal instructions to contract pelvic floor muscles. each contraction will be performed 3 time with rests of 10 sec between contractions. while the first 2 contractions for each verbal instruction will be held for 3 sec. the last contraction will be held as long as the participant can conduct and the time of contraction will be measured as well. the pelvic floor contraction will be measured by assessing bladder displacement via diagnostic ultrasound. to image the pelvic floor a 5 mhz curved linear array transducer (mindray m5) will be placed in the transverse plane immediately suprapubically over the lower abdomen angled at 15-30 degrees from the vertical. an on screen caliper and measurement tool will be used to measure bladder displacement.

Eligibility criteria:
inclusion criteria: * willing to participate in the study exclusion criteria: * none

Keywords: verbal instruction, pelvic diaphragm, muscle contraction
study of anti-igf-ir cp-751,871 in patients with solid tumors

Conditions: Sarcoma, Ewing's

Summary: this is a phase 1 study of anti-igf-ir cp-751,871 in patients with solid tumors currently enrolling patients 9 years old and older with ewing's sarcoma family of tumors (ewing's, pnet and askin's).


Eligibility criteria:
inclusion criteria: * diagnosis of ewing's sarcoma family tumors exclusion criteria: * concurrent treatment with any other anti tumor agents
real-world evaluation of beovu (brolucizumab) effectiveness and durability for treatment of neovascular (wet) age-related macular degeneration (amd)

Conditions: Neovascular (Wet) Age-related Macular Degeneration

Summary: this was a retrospective, observational cohort study. data were analyzed from the intelligent research in sight (iris) registry from october 8, 2019, through november 26, 2021, with a follow-up period of 12 months following the first brolucizumab injection (index date).


Eligibility criteria:
inclusion criteria: * at least 18 years old at the time of their first (index) injection of brolucizumab. * had documented neovascular age-related macular degeneration (namd) on or within 3 years before the index injection. * used only brolucizumab for at least 12 months (± 45 days) after the index injection, with at least 1 brolucizumab injection given within the first 6 months after the index injection and at least 1 additional brolucizumab injection given at 6-12 months after the index injection. exclusion criteria: * had received any other anti-vegf agent between the index injection and 12-month follow-up. * lacked information about the laterality of disease at the time of the index injection. * lacked visual acuity assessments on or within 30 days before the index injection or at 6, 9, and 12 months after the index injection (all of the latter ± 45 days).
analgesic effect of infraspinatus-teres minor block for pre-emptive analgesia in patients undergoing shoulder surgeries.

Conditions: Preemptive Analgesia

Summary: the aim of the study to evaluate the efficacy of the infraspinatus-teres minor (itm) block in improving pre-emptive analgesia, reducing opioid consumption, and enhancing the overall analgesic effect in patients undergoing shoulder surgeries.

to compare between infraspinatus-teres minor versus control group (ga): 1. to measure analgesic parameters including: the total amount of rescue analgesic consumption (morphine) in the first 24 hours post-operatively in each group, duration of analgesia, and total amount of intraoperative fentanyl consumption and 2. to assess pain score by using numerical rate scale (nrs) at rest (static) and during passive or active movement of shoulder joint (dynamic). 3. to assess discharge time from post anesthesia care unit (pacu). 4. to assess side effects of systemic opioids (constipation, itching, dizziness, nausea and vomiting) and complications of infraspinatus-tere minor block. 5. patients' satisfaction: the patients will be asked to rate the overall degree of satisfaction of the analgesia by using a 5-points likert-like verbal scale (1 = very dissatisfied analgesia, 2 = dissatisfied analgesia, and 3 = neutral, 4=satisfied analgesia, and 5=very satisfied analgesia).

Eligibility criteria:
inclusion criteria: * • patients' acceptance. * age: adults aged 21-65 years old. * bmi: 25-30 kg/m2 * sex: both sexes (males or females). * patients undergoing unilateral shoulder surgey under general anesthesia. * asa (american society of anesthesiologists) physical status classification i to ii. * duration of the surgery \< 3hours. exclusion criteria: * • patients with contraindications to regional anesthesia (e.g. local or systemic infections, or severe neurological or muscular or bleeding disorders or patient on anticoagulant). * allergy to study medications: bupivacaine or dexamethasone, or dexmedetomidine * patients with severe cardiovascular, respiratory, renal, or hepatic diseases, uncontrolled diabetes , or those undergoing chronic opioid therapy. * psychiatric disorders that hinder informed consent or study participation. * history of neurological diseases or conditions that would affect the efficacy of nerve blocks (e.g., neuropathy, spinal cord injury, or history of severe muscle weakness). * patients with nerve injury or disease around the shoulder joint, including thoracic outlet syndrome, multiple sclerosis, cervical disc disease with ipsilateral radiculopathy, or patients with abnormal sensory or motor function of the upper limb.

Keywords: infraspinatus teres minor block preemptive analgesia shoulder surgery
dexmedetomidine and bupivacaine with bupivacaine in ultrasonography guided fascia iliaca compartment block in adults

Conditions: Femoral Fractures

Summary: few studies have reported the efficacy of adding dexmedetomidine to bupivacain for fascia illiaca compartment black. comparison of dexmedetomidine and bupivacaine with bupivacaine alone on the quality of ultrasonography guided fascia iliaca compartment block in adults undergoing femur fracture fixation surgery at 2014.


Eligibility criteria:
inclusion criteria: * adults with femural fracture exclusion criteria: * hypersensitivity to drugs * neurological diseases * coagulation abnormalities * infection at the site of block

Keywords: femoral fractures
efficacy of promescent lidocaine spray in men with premature ejaculation

Conditions: Premature Ejaculation

Summary: the purpose of this study is to evaluate the efficacy of treatment with promescent lidocaine spray compared with placebo in patients with premature ejaculation.

promescent lidocaine spray is a non-prescription drug that is marketed under an over-the-counter drug monograph (21 cfr section 348.10 subpart b (a)(2)) for male genital desensitizing drug products. in addition the evaluating the efficacy of treatment with promescent, this study will evaluate patients' subjective distress, perception of improvement and optimal dose, and safety and tolerability of promescent for patients with premature ejaculation and their respective partners.

Eligibility criteria:
inclusion criteria: * subject has provided written informed consent before screening. * subject is a male, 18 years of age or older. * subject meets the diagnostic criteria for premature ejaculation as defined by the dsm-iv-tr (diagnostic and statistical manual of mental disorders, 4th edition, text revision; 2000). * subject has a stable, monogamous, heterosexual relationship and sexually active for at least the last 6 months. * subject and partner are willing and able to engage in sexual intercourse. exclusion criteria: * subject has never achieved an intravaginal ejaculation during the past 6 months (i.e., always ejaculates prior to penetration). * subject has other forms of ejaculatory dysfunction (e.g., retrograde ejaculation, anejaculation, painful ejaculation). * in the opinion of the investigator, the subject has a condition or is in a situation that may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's ability to participate in the study.

Keywords: premature ejaculation lidocaine
smart phone app for colonoscopic preparation

Conditions: Colorectal Cancer Screening; Colonoscopy; Mass Screening

Summary: this is a randomized controlled trial designed to assess the efficacy of a novel smartphone application as an automated reminder tool in improving the quality of bowel preparation for patients undergoing outpatient colonoscopies. the investigators will be comparing the smartphone application to traditional instructions for bowel preparation. the quality of bowel preparation will be assessed using the ottawa and aronchick bowel preparation scales.

this is a randomized controlled trial designed to assess the efficacy of a novel smartphone application as an automated reminder tool in improving the quality of bowel preparation for patients undergoing outpatient colonoscopies at an academic teaching hospital in kingston, ontario. the intervention under investigation is the use of a novel smart phone application which serves as an automated reminder system for patients undergoing outpatient colonoscopies. the application requires the patients to enter the date and time of the colonoscopy appointment and automatically populates the patients' phones with calendar reminders as well as pre-recorded messages regarding cessation of solid food intake, the need for clear fluid intake, as well as timing of their bowel regimens starting 7 days prior. the design of this study is a prospective, randomized controlled trial with single blinding (endoscopist). eligible participants will be randomized into either the control (routine paper instructions) or the intervention group (smart phone application). those who are randomized into the intervention group will be provided with specific instructions to download and setup the smart phone application at least 7 days prior to their scheduled appointment. upon arrival to their appointment, participants in both groups will be asked to complete a survey confirming the adherence to either paper instructions or instructions provided by the smart phone application. the primary outcome of this study is the adequacy of the bowel preparation, as assessed by using the ottawa and aronchick bowel preparation scales, which have been previously validated and are in common usage for colonoscopy procedures. secondary outcomes include rate of polyp detection, rate of cecal intubation, and patient reported ease of use and adherence to the bowel regimen instructions.

Eligibility criteria:
inclusion criteria: * access to smart phone with the ability to download smart phone application * outpatient screening colonoscopy exclusion criteria: * patient refusal * bowel preparation other than pico-salax or golytely * urgent/emergent colonoscopy * patient requiring combined upper and lower endoscopic evaluation * no access to smart phone or inability to download smart phone application * surveillance colonoscopy for previously resected cancer * inflammatory bowel disease

Keywords: smart phone application bowel preparation colorectal cancer screening