Kornimate/medical-research-clean huggingface dataset:
long-term pf-06651600 for the treatment of alopecia areata

Conditions: Alopecia Areata

Summary: this is a global phase 3 study to evaluate the safety and effectiveness of an investigational study drug (called pf-06651600) in adults and adolescents (12 years and older) who have alopecia areata. eligible patients from the prior studies b7931005 (nct02974868) and b7981015 (nct03732807) will have an opportunity to enroll as well as patients who have not previously participated in either of these studies. the study is open-label and all patients entering the study will receive active study drug. a sub-study of approximately 60 adult patients who are participating in the b7981032 study will be conducted at select sites in the us, australia and canada. the sub-study will evaluate the immune response to tetanus and meningococcal vaccines in patients who have received a minimum of 6 months of 50 mg pf-06651600.


Eligibility criteria:
inclusion criteria- for de novo participants and participants from study b7931005 and b7981015 with \>30 days between first visit in b7981032 and last dose in the prior study: * clinical diagnosis of alopecia areata (aa) with no other cause of hair loss. androgenetic alopecia coexistent with aa is allowed. * de novo participants \>=12 to \ =50% terminal hair loss of the scalp due to aa, including alopecia totalis and alopecia universalis * de novo participants \>=18 years of age and participants from study b7931005 or b7981015 with \>30 days between first visit in b7981032 and last dose in the prior study: \>=25% terminal hair loss of the scalp due to aa, including alopecia totalis and alopecia universalis * no evidence of terminal scalp hair regrowth within 6 months (de novo only) * current episode of terminal scalp hair loss \<=10 years (de novo only) exclusion criteria- for de novo participants and participants from study b7931005 and b7981015 with \>30 days between first visit in b7981032 and last dose in the prior study: * hearing loss with progression over previous 5 years, or sudden hearing loss, or middle or inner ear disease, or other auditory condition that is considered acute, fluctuating or progressive * history of or current malignancies with the exception of adequately treated or excised non metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in situ * history of a single episode of disseminated herpes zoster or disseminated herpes simplex, or a history of more than one episode of localized, dermatomal herpes zoster * infection requiring hospitalization, or parenteral antimicrobial therapy within 6 months prior to day 1 exclusion criteria for all participants: - participants who have previously taken janus kinase (jak) inhibitors other than pf-06651600 must have received the last dose \>12 weeks prior to the screening visit

Keywords: alopecia alopecia areata alopecia totalis alopecia universalis hair loss jak inhibitor pf-06651600 ritlecitinib
screening for atrial fibrillation among older patients in primary care clinics

Conditions: Atrial Fibrillation

Summary: the overall goal of this study is to assess the effectiveness of screening for undiagnosed atrial fibrillation (af) using simple, efficient, and portable electronic health and mobile technologies in a healthcare system. the investigators propose to perform population-based screening for undiagnosed af as part of usual care in patients ≥ 65 years when their vital signs are checked (spot-check) at scheduled outpatient visits in adult massachusetts general hospital (mgh) primary care clinics. patients will receive routine care by their primary care provider (pcp) based upon the results of the screening during the visit. the investigators hypothesize that rates of af detection among individuals ≥ 65 years in the mgh primary care network will be greater among patients in clinics assigned to the spot-check arm compared to patients in clinics assigned to the usual care arm of the study.


Eligibility criteria:
inclusion criteria: * patients aged 65 years or older * presenting for an outpatient clinic appointment at a participating clinic * visit with a physician, nurse practitioner, or physician's assistant exclusion criteria: * have a primary care physician outside of the network * do not visit their primary care practice during the study period
monitoring of nontraumatic chest pain borne by the "department of emergency help medicalized" (samu)

Conditions: Chest Pain

Summary: support pre-hospital chest pain remains a difficult problem in both pre hospital regulation that when supported by the mobile services emergency and intensive care (smur). this ground of appeal underlying various pathologies especially acute coronary syndrome whose early care diagnostic and treatment significantly improves the prognosis. the recognition and management of sca is therefore a public health issue. myocardial infarction (mi) is responsible for 10 to 12% of the total annual mortality in adults and coronary heart disease is the leading cause of death in france. no studies have assessed the adequacy of regulation and management of chest pain samu for the diagnosis of sca. the main objective of the research is to have a descriptive analysis of the population controlled by the samu and the population served by the mobile emergency with chest pain. also evaluate the adequacy of the proposed direction by the ambulance samu/smur and the final diagnosis and direction after passing emergency, cardiology and at follow-up to a year.

course of study: * call the ambulance dispatch center: anamnestic data will be collected by the regulator on a medical report forms the patient is identified by an anonymous number, "number of samu business". the cra of centre concerned, from this number of case (using the database of samu) capture, in the database of the french society of cardiology - fsc - the patient identification data (name , surname, date of birth, address, telephone number and the name and address of attending physician, these data will be necessary for the cra to the fsc to follow up to 1 year) * smur: if the patient arrives at smur, anamnestic data, clinical, laboratory, ecg, therapeutic, diagnostic and referral will be collected by the contact center on a paper crf or on the computerized database of cfs by centers. * emergency service: if the patient comes to the er, the clinical, laboratory, ecg, diagnostic output will be collected on a paper crf or the computerized database of cfs according to the center by the referent of centre concerned. * cardiology service : if the patient arrives in the cardiology service, laboratory, ecg, diagnostic output will be collected on a paper crf or the computerized database of cfs according to the center by the referring cardiologist dolores center.

Eligibility criteria:
inclusion criteria: * patient who called uas-acs for a non-traumatic chest pain * patient who agreed to participate in the study. exclusion criteria: * traumatic grief * patient refusal to participate in the observatory

Keywords: cardiology
a study to evaluate the use of glucocorticoids in combination with tocilizumab in daily clinical practice

Conditions: Rheumatoid Arthritis

Summary: this prospective, multicenter, observational study will evaluate the use of concomitant glucocorticoid therapy in adults with rheumatoid arthritis (ra) being treated with tocilizumab in daily clinical practice. participants will be observed for up to 52 weeks after starting treatment with tocilizumab. all visits and assessments will be performed as per routine clinical practice, with no study-specific visits or interventions.


Eligibility criteria:
inclusion criteria: * diagnosis of moderate to severe ra, defined as das28 greater than or equal to 3.7 * naive to tocilizumab, or received tocilizumab within 8 weeks prior to enrollment * physician has made decision to commence iv or sc tocilizumab in accordance with label and reimbursement criteria * treated with glucocorticoids for ra when starting tocilizumab treatment exclusion criteria: * treatment with any investigational agent within 4 weeks or 5 half-lives before tocilizumab * continuous or regular treatment with oral corticosteroids for any indication other than ra
muscular electrostimulation of the sedated and mechanically ventilated critically ill patient. analysis of the effect on acquired muscular weakness and its clinical consequences.

Conditions: Polyneuropathy

Summary: even 20-50% of patients under sedation and mechanical ventilation develops myopathy and / or neuropathy which difficulties both the process of extubation and the functional recovery. the objective of this project is to analyze the effect of muscle electrostimulation (esm) on muscle weakness acquired in intensive care unit (icu) and its consequences. study design: a single center, prospective, randomized trial to be held in the icu of " universitarian hospital la fe" in collaboration with the service of neurophysiology of the hospital. all patients undergoing sedation and mechanical ventilation (with an expected duration longer than 48h) and without any of the exclusion criteria detailed in the methodology section will be included in the study. the intervention will consist of a muscular electrostimulation with the super pro excel 70,ultratonetm. the stimulation will be performed in 10 muscle groups (5 per side) following established protocols, at least 5 days a week. we will evaluate muscle strength by medical research council scale, functional capacity by barthel scale and neurophaty disability scale, all clinical events will be collected and electrophysiologic, echographic and histologic parameters will be measured. the process of extubation will be performed following an established protocol, the duration will be collected as the same manner as icu.


Eligibility criteria:
inclusion criteria: * patients older than 18 years. * sedated and mechanically ventilated critically ill patients, more than 48 hours. exclusion criteria: * body mass index \> 45 or \< 20 kg/m2. * pregnant. * epilepsia. * use muscular blocks.

Keywords: muscular electrostimulation, mechanically ventilated, critically ill patients, muscular weakness.
early sars-cov-2 tracheostomy

Conditions: Tracheostomy; Characteristics Disease; Metabolic Disturbance

Summary: objective of this case series was to evaluate the characteristics of early covid-19 tracheostomy and its effect on laboratory parameters. a series of 17 patients with covid-19undergo surgical tracheostomy in our intensive care unit. demographic parameters, duration indicators, and laboratory parameters before and after tracheostomy were analyzed in patients. of the 17 patients, 4 were men and 13 women with a mean age of 59 years. the average length of total hospitalization were 12 days, the length of stay in intensive care were 10 days, the length of endotracheal intubation were 9 days, with the seventh day of tracheotomy. neurological and thyroid diseases and withdrawal had a statistically significant difference (p \<0.05), with laboratory parameters without statistically difference. critically ill covid-19 patients undergoing early tracheostomy has a lower possibility of weaning from mechanical ventilation, and early tracheostomy itself has no significant effect on renal parameters, lactate and d-dimer.


Eligibility criteria:
inclusion criteria: * covid-19 postive patients * surgery tracheostomy patients exclusion criteria: * trachestomy before admission in the icu

Keywords: covid-19 tracheostomy demographic lactate d-dimer
nutrition-focused approach during cgm initiation: a qualitative study

Conditions: Type 2 Diabetes

Summary: the purpose of the qualitative research is to provide a deeper understanding of the perspectives of people with type 2 diabetes (t2d) who received a nutrition-focused approach (nfa) when initiating continuous glucose monitor (cgm).

the purpose of the qualitative research is to provide a deeper understanding of the perspectives of people with t2d who received the nfa when initiating cgm. a single 30-minute semi-structured interview will be conducted in approximately 15 people who have completed participation in the a21-292 study (also called the my diabetes study). the my diabetes study, is a randomized clinical trial to assess the impact of using a nfa or a self-directed approach during cgm initiation. the nfa was developed specifically for the randomized clinical trial study.

Eligibility criteria:
inclusion criteria: * participant was randomized to the nutrition-focused approach arm of the my diabetes study * participant completed all required study visits in the my diabetes study; this includes the baseline visit, the two intervention visits, and the study completion visit * participant had at least 70% "time cgm active" on a 10-day dexcom clarity report at study completion visit * participant is willing to be recorded during the interview exclusion criteria: * participant was randomized to the self-directed approach study arm of the my diabetes study * participant is deemed unsuitable for participation due to any cause as determined by the investigator

Keywords: continuous glucose monitor cgm nutrition qualitative interview
tissue optimization on cryolipolysis procedures for fat layer reduction

Conditions: Body Fat Disorder

Summary: evaluate the effects of tissue optimization before and during cryolipolysis procedures on the outcome of non-invasive fat reduction using the zeltiq system.


Eligibility criteria:
inclusion criteria 1. male or female subjects \> 18 years of age and \< 65 years of age. 2. subject has clearly visible fat on intended treatment area, which in the investigator's opinion, may benefit from the treatment(s). 3. subject has not had weight change exceeding 10 pounds in the preceding month. 4. subject with body mass index (bmi) less than 30. bmi is defined as weight in pounds multiplied by 703 divided by the square of the height in inches. 5. subject agrees to maintain his/her weight (i.e., within 5 pounds) by not making any major changes in their diet or lifestyle during the course of the study. 6. subject has read and signed a written informed consent form. exclusion criteria 1. subject presents a significant asymmetry of intended treatment areas. 2. subject has had a surgical procedure(s) in the area of intended treatment in the past 5 years. 3. subject has had an invasive fat reduction procedure (e.g., liposuction, abdominoplasty, mesotherapy) in the area of intended treatment in the past 5 years. 4. subject has had a non-invasive fat reduction and/or body contouring procedure in the area of intended treatment within the past 6 months. 5. subject needs to administer, or has a known history of subcutaneous injections into the area of intended treatment (e.g., heparin, insulin) within the past month. 6. subject has a known history of cryoglobulinemia, cold urticaria, or paroxysmal cold hemoglobinuria. 7. subject has a known history of raynaud's disease, or any known condition with a response to cold exposure that limits blood flow to the skin. 8. subject has a history of bleeding disorder or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising. 9. subject is taking or has taken diet pills or weight control supplements within the past month. 10. subject has any dermatological conditions, such as moderate to excessive skin laxity, or scars in the location of the treatment sites that may interfere with the treatment or evaluation (stretch marks is not an exclusion). 11. subject has an active implanted device such as a pacemaker, defibrillator, or drug delivery system. 12. subject is pregnant or intending to become pregnant in the next 5 months. 13. subject is lactating or has been lactating in the past 6 months. 14. subject has a history of hernia in the areas to be treated. 15. subject is unable or unwilling to comply with the study requirements. 16. subject is currently enrolled in a clinical study of any other unapproved investigational drug or device. 17. any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject.

Keywords: lipolysis cryolipolysis fat reduction
phase ii trial of pulsed taxol with concurrent thoracic radiotherapy, & adjuvant chemo in stage iii nsclc

Conditions: Non Small Cell Lung Cancer

Summary: this is a phase ii study to evaluate the toxicity and overall survival of pulsed paclitaxel with concurrent thoracic radiotherapy, and adjuvant gemcitabine and carboplatin in stage iiia and iiib non-small cell lung cancer

objectives primary 1. overall survival 2. tumor response using recist criteria secondary 1. determine the toxicity of the proposed treatment in this patient population. 2. progression free survival 3. locoregional control 4. distant failure study design description of the study phase ii study to evaluate the toxicity and overall survival of pulsed paclitaxel with concurrent thoracic radiotherapy, and adjuvant gemcitabine and carboplatin in stage iiia and iiib non-small cell lung cancer. rationale for study design the proposed doses of gemcitabine, carboplatin, paclitaxel, and thoracic radiation therapy have been previously studied and deemed safe. the design of this study is not to find the maximum tolerated dose (mtd) of these agents, but to study the toxicity and overall survival from this combination. outcome measures primary outcome measures 1. overall survival 2. tumor response using recist criteria secondary outcome measures 1. locoregional control 2. distant failure 3. progression free survival

Eligibility criteria:
inclusion criteria: 1. patients must have: iiia or iiib non-small cell lung cancer by radiographic or surgical staging, excluding: superior sulcus tumors, tumors with associated atelectasis or obstructive pneumonitis of the entire lung, and tumors with a malignant pleural effusion. 2. patients will be included in the study based on the following criteria: * patients must be older than 18 years old. * patients must have a zubrod performance status of 0 to 2 * patients with adequate bone marrow function * patients with adequate renal function * patients with adequate hepatic function * patients of childbearing potential must have a negative serum pregnancy test and use an effective form of contraception. * patients who are suitable for treatment with radical intent using concurrent chemotherapy and radiation. * patients who have signed an approved informed consent and authorization permitting release of personal health information. exclusion criteria: 1. disease-specific exclusions * superior sulcus tumors * atelectasis or obstructive pneumonitis of the entire lung * malignant pleural effusion 2. general medical exclusions * surgical candidates * patients who are pregnant at the time of diagnosis * serious concomitant systemic disorders incompatible with the study * inability to comply with study and/or follow-up procedures * life expectancy of less than 12 weeks * current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study * patients with septicemia or severe infection. * patients who have circumstances that will not permit completion of this study or the required follow-up * patients with any contraindication to gemcitabine, carboplatin, or paclitaxel
oxytocin pharmacokinetics and pharmacodynamics

Conditions: Post Partum Hemorrhage; Cesarean Section Complications; Blood Loss

Summary: oxytocin is the first-line drug to promote contraction of the uterus and prevent atony immediately after delivery. nonetheless, unpredictable uterine atony refractory to oxytocin affects roughly 250,000 parturients annually in the u.s. and rates are increasing. this two-part study will measure the action of oxytocin at cesarean delivery. the first part will measure the pharmacokinetics of a single intravenous (iv) dose of deuterium-labeled oxytocin. the second part will measure the pharmacodynamics of all plasma oxytocin to see how concentrations correspond to the contractile effect on the uterus. after delivery of the fetus, study subjects will receive a bolus of iv deuterated oxytocin followed by an unlabeled oxytocin infusion. venous blood samples drawn at multiple time points (within 1 hour after delivery) will be analyzed for plasma concentrations of labeled and unlabeled (endogenous + exogenous infused) oxytocin over time. plasma concentrations will be compared with 0-10 uterine tone scores measuring uterine contraction strength, to describe the concentration-effect relationship. the goal of this study is to define both the pharmacokinetics and pharmacodynamics of oxytocin in parturients to help identify the cause(s) of failed first-line oxytocin therapy.

parturients aged 18-50 with an intrauterine term pregnancy (37 weeks or greater) undergoing non-emergent cesarean delivery at the university of chicago (uc) and stanford university will be recruited. methods: all subjects will receive standard pre-, intra- and postoperative care for their cesarean delivery with additional study interventions. study subjects will have an additional intravenous (iv) catheter inserted for intra-operative study-related blood draws. a single, 1 international unit (iu) bolus of deuterated oxytocin (d5ot) will be given to the subject, followed by an infusion of standard protocol oxytocin immediately after placental delivery. iv samples will be drawn from the study iv at 0, 1, 2.5, 5, 10, 20, 30, 45, 60 minutes following administration of the study drug. the samples will be processed, batched and shipped to the central lab being used in this study. uterine tone scores will be measured simultaneously with blood draws until accurate palpation is no longer possible. uterine tone score is a 0 to 10 numeric rating scale with 0 to describe unsatisfactory or no uterine tone and 10 to describe perfect uterine tone.

Eligibility criteria:
inclusion criteria * 18-50 years old * intrauterine pregnancy * term (\>39 weeks gestation or 37-39 weeks gestation with fetal or maternal medical indication for delivery) pregnancy * non-emergent (scheduled or unscheduled) cesarean delivery exclusion criteria: * allergy or contraindication to oxytocin * inability to provide informed consent

Keywords: oxytocin pharmacokinetics and pharmacodynamics uterine tone postpartum elective c-section parturients