Kornimate/medical-research-clean huggingface dataset:
a study of cyp-001 for the treatment of steroid-resistant acute graft versus host disease

Conditions: Graft vs Host Disease

Summary: the purpose of this study is to assess the safety, tolerability and efficacy of two infusions of cyp-001 in adults with steroid-resistant gvhd.

this is a multi-centre, open label, dose escalation study to assess the safety, tolerability and efficacy of two infusions of cyp-001, in adults who have steroid-resistant gvhd. participants will receive standard of care treatment throughout the study, according to local procedures. the first eight participants will be enrolled in cohort a and receive a cyp-001 dose of 1 million cells per kg, up to a maximum dose of 100 million cells, on day 0 and day 7. subject to a safety review of data from cohort a, an additional eight participants will be enrolled into cohort b and receive a cyp-001 dose of 2 million cells/kg, up to a maximum dose of 200 million cells, on day 0 and day 7. the primary evaluation period concludes for each participant 100 days after the first dose of cyp-001. participants will have study visits on days 0, 3, 7, 14, 21, 28, 60 and 100. subsequently, participants will enter a long term follow-up period, which concludes 2 years after the first dose of cyp-001.

Eligibility criteria:
inclusion criteria: * diagnosis using consensus grading with steroid-resistant grade ii-iv acute gvhd, after a haematopoietic stem cell transplant for a haematological disorder. * life expectancy of at least one month. * agree to have follow-up data collected for two years after their initial dose of cyp-001 (under a separate protocol). exclusion criteria: * pregnant or breastfeeding or plan to become pregnant within three months of receiving their last dose of cyp-001. * have received any investigational research agent within 30 days or five half-lives (whichever is longer) prior to the first dose of imp. * known or suspected current alcohol or substance abuse problem. * progressive or relapsing haematological malignancy, a current solid tumour, or previous malignant solid tumour that is likely to recur during the period of the study (with the exception of a past history of basal or squamous cell carcinomas). * heart failure (nyha functional class ii-iv) and/or pulmonary failure. * haemodynamically unstable and/or at high risk of cardiovascular events. * terminal organ failure. * meningitis, pneumonia with hypoxemia, hiv or another severe or uncontrolled systemic infection, which in the opinion of the investigator is likely to impact on the ability of the patient to participate in the trial.
use of nava-catheter positioning screen to identify different cardiac arrhythmias

Conditions: Cardiac Arrhythmia

Summary: the purpose of this study is to validate a novel method of diagnosing arrhythmias using the nava catheter-positioning screen in patients who have a nava catheter in place.

the population will be a convenience sample of adults with various arrhythmias who are scheduled to undergo an electrophysiology study and-or ablation (epsa) under general anesthesia (geta) at the toledo hospital. after the patient has been successfully intubated at the beginning of the procedure, a trained nurse, using standard technique for placement of a oro/nasogastric tube, will place an appropriately sized nava catheter in the patient. the lumen of the nava tube can be used as a conventional oro/nasogastric tube and the electrodes will be connected to the servo-i ventilator. although the servo-i is a ventilator, it will be used only as a monitor for this study. the position of the nasogastric tube will then be refined using the catheter positioning screen as needed. during the course of the epsa various arrhythmias may become evident. when these are noted, screen shots will be saved on the servo-i monitor. surface and electrogram recordings will be saved at the same time. the nava catheter will be disconnected from the servo-i monitor during the ablation part of the procedure to prevent inadvertent damage to the monitor.

Eligibility criteria:
inclusion criteria: * cardiac arrhythmia exclusion criteria: * pregnancy
comparison of bupivacaine wound infiltration versus wound instillation to minimize postoperative pain after thyroid surgery

Conditions: Thyroid Surgery

Summary: pain management following thyroidectomies, which can cause mild to moderate postoperative pain, particularly in the first 24 hours following surgery, has received little attention . the incision of the wound, neck hyperextension, retraction of the wound margins during surgery, and dissection are the main reasons of post-thyroidectomy discomfort . after thyroid surgery, pain management improves patients' quality of life and facilitates a speedy return to regular daily activities. the aim of the study to evaluate the effects of bupivacaine instillation after thyroidectomy against infiltration into the surgical field in order to reduce postoperative discomfort following thyroid surgery.

pain management following thyroidectomies, which can cause mild to moderate postoperative pain, particularly in the first 24 hours following surgery, has received little attention . the incision of the wound, neck hyperextension, retraction of the wound margins during surgery, and dissection are the main reasons of post-thyroidectomy discomfort . after thyroid surgery, pain management improves patients' quality of life and facilitates a speedy return to regular daily activities.

Eligibility criteria:
inclusion criteria: * normal thyroid function patients of both genders scheduled for thyroid surgery will included in this study * if they are over the age of 18 * if they had an asa score (american society of anesthesiology) i, ii. * a score of mallampati i , ii. exclusion criteria: * patient refused to participate in the study. * patients will be excluded if they have any analgesic medication or corticosteroid drug prior surgery or * a known or suspected allergy to local anesthetics, * if the duration of surgery is greater than 5 h and if a major complication of surgery or anesthesia (major bleeding, allergy to anesthetic products). * patients who have lateral neck dissection associated with thyroid surgery are excluded.
factors associated with pain threshold in young adults with chronic neck pain

Conditions: Neck Pain Chronic

Summary: the aim of this study was to determine which factors affect treatment expectations in individuals with chronic neck pain.


Eligibility criteria:
inclusion criteria: * to be examined by specialised physicians and diagnosed with chronic neck pain, to be physically and mentally fit to participate in the study. exclusion criteria: * the presence of instability in the neck joints, trauma within the last year, severe osteoporosis, previous neck surgery, physical therapy within the last 6 months, neurological findings or radiculopathy were determined.
changing of dressing for periprosthetic joint infection in total knee arthroplasty

Conditions: Infection; Surgical Site Infection; Prosthetic Infection; Wound Infection

Summary: the primary aim of the study is to compare two methods for a relationship with total knee infection: regular changing of dressings and not changing dressings.

periprosthetic joint infection (pji) is one of the most dreaded complications that occur after total joint arthroplasty. periprosthetic joint infection remains an uncommon yet devastating complication that continues to influence the outcome of total joint arthroplasty. (1-4) although different dressing methods have been described, the effect of changing the frequency of conventional dressings on pji is curious. after obtaining informed consent from all participants, parallel-group randomization will be performed with the help of a computer. the first dressing of all participants will be done in the operating room using the same materials. no drains will be used in any patient. then, according to the randomization, the procedures will be adjusted by the wound care nurse with the patient. all on-study and outcome data will be collected by the study staff blinded to study group assignment. the dressing group participants will be dressed by the same wound care nurse during the discharge. the dressing group participants will be dressed by the same wound care nurse in an outpatient service every three days using the same material. the total dressing number will be in the dressing group participant 5 times. both group participants will be evaluated in the outpatient service after 2 weeks. subsequently, all participants will be invited to check-in at the end of each month. all participants will be evaluated according to msis criteria in terms of superficial and deep periprosthetic infection. the primary endpoint is to detect the difference between the incidence of periprosthetic infection after the regular dressing change and the incidence of the dressing unchanged group. in the secondary endpoint, it is to determine whether dressing change is an independent factor with multiple logistic regression test.

Eligibility criteria:
inclusion criteria: * participants who agreed to inclusion in the study exclusion criteria: * missing follow-up * participants with insufficient data
development of a money advice intervention within iapt

Conditions: Mental Health Issue; Anxiety; Depression

Summary: this study is the second study of a larger project and will begin the process of testing and the development of an integrated intervention on a series of case studies. the combined intervention provides psychological therapy and debt advice in tandem. the treatment pathway is based on interviews and focus groups with service users and staff and the themes that emerged. it will be trialled in the nhs' improving access to psychological therapies (iapt) service. participants routinely accessing this service who have debt issues affecting their mental health will be asked if they'd like to also take up support for their money worries, which will be provided by citizen's advice (ca). researchers will take exit interviews with both service users and staff at the end of the treatment to develop the protocol further. researchers will also assess measures of mental health and wellbeing that are routinely taken by iapt to review the intervention.


Eligibility criteria:
inclusion criteria: * iapt clients referred for 'high-intensity' one-to-one treatment in the south london and maudsley nhs trust (slam) * have mental health problems and experience of money problems that are effecting these * can access technology exclusion criteria: * inability to give informed consent due to mental incapacity (as assessed by iapt therapists) * participants whose care team specify concerns regarding taking part in the study.
treatment of non-cardiac chest pain with imipramine or cognitive-behavioral therapy

Conditions: Chest Pain

Summary: approximately 75,000-150,000 patients each year in the united states undergo intensive cardiac evaluations for symptoms of angina-like chest pain that produce no positive findings. these patients often have high levels of disability and suffering and account for $250,000,000-$500,000,000 in estimated health care costs each year. there is some evidence from randomized, controlled trials that a pharmacologic agent, imipramine, and a program of training in pain coping skills and cognitive-behavioral therapy (cbt) both produce short-term reductions in pain intensity. however, no studies have compared the effects of these two treatments on measures of pain, suffering, and disability at post-treatment and over a one-year follow-up period. our investigation is a 16-week, randomized controlled outcome study of these interventions and their respective placebo control procedures. one hundred and sixty patients are being recruited for this study. we will assess the effects of our interventions on patients' pain levels, quality of life, and health care resource usage at baseline, post-treatment, 6-month follow-up, and at 12-month follow-up. we will evaluate the clinical significance of our treatment effects as well as their statistical significance.


Eligibility criteria:
inclusion criteria: * substernal chest pain at least 2x per week for at least 3 months; * angiographic evidence of normal or non-obstructive (\ 40 years of age; or normal exercise stress tests, normal echocardiogram, and cardiologist evaluation that symptoms are not cardiac in origin among subjects \< 40 years of age; * gastroesophageal reflux disease ruled out by 24-hour ph monitoring, endoscopy, or 1-month trial of anti-reflux therapy with omeprazole 20 mg bid; * pain threshold levels for esophageal balloon distention must be 12 ml. exclusion criteria: * mitral valve prolapse

Keywords: imipramine cognitive-behavioral therapy
a safety study of intravitreal pp-001 in patients with chronic, non-infectious uveitis

Conditions: Non-infectious Uveitis

Summary: in this study, pp-001 is assessed for safety and efficacy in patients diagnosed with non-infectious chronic uveitis. pp-001 is a novel small molecule that inhibits a specific enzyme (dihydroorotate dehydrogenase) and has shown pre-clinical efficacy in treatment of non-infectious uveitis. pp-001 will be administered to participants as a single intravitreal injection in ascending doses.

this study assesses safety and efficacy of pp-001 after intravitreal injection in patients diagnosed with non-infectious chronic uveitis. pp-001 is a novel small molecule inhibitor of dihydroorotate dehydrogenase (dhodh) and has shown pre-clinical efficacy in treatment of non-infectious uveitis. pp-001 is to offer a local treatment alternative to corticosteroids with the objective to reduce or possibly replace steroid intake of non-infectious uveitis patients. in the current study, pp-001 will be injected in ascending doses into the vitreous body of the eye of study participants who suffer from non-infectious uveitis. participants will be monitored for safety and efficacy evaluation of the study drug.

Eligibility criteria:
inclusion criteria: * male or female patients at the age of 18 years or older who have diagnosis of chronic, posterior uveitis, intermediate uveitis or panuveitis exclusion criteria: * patients receiving specific medication/interventions as specified per protocol * pregnant or nursing patients
cornell translational behavioral science research consortium: hypertension qualitative study

Conditions: Hypertension

Summary: to explore the meaning, causes and treatment of hypertension in eligible patients. in addition the cultural, social, and psychological factors that either facilitate or serve, as barriers to behavioral change will be illuminated in this patient population.

1. the first goal is to explore the meaning, causes and treatment of hypertension in eligible patients. in addition the cultural, social, and psychological factors that either facilitate or serve, as barriers to behavioral change will be illuminated in this patient population. through a series of open-ended questions we will explore and build a better understanding of how hypertensive african american patients view their illness and the difficulties they have in taking their antihypertensive medications as prescribed. 2. the second goal of the qualitative phase is to use the responses obtained to inform how we should operationalize and tailor the positive affect induction and self-affirmation intervention methods in hypertensive african american patients.

Eligibility criteria:
inclusion criteria: 1. patients must be self-identified as african-americans. 2. all patients must be aged 18 years and older. 3. all patients must be diagnosed as having hypertension: for this project, hypertension will be defined according to the widely accepted criteria of the 6th joint national committee (jnc vi) guidelines on prevention, detection, evaluation and treatment of hypertension, which is a systolic blood pressure \> 140 mm hg or a diastolic blood pressure \> 90 mm hg or if participants are taking any prescribed antihypertensive medication. 4. patients must be able to provide informed consent in english. exclusion criteria: 1. patients who refuse to participate 2. patients who are unable to provide informed consent.

Keywords: african american hypertension medication adherence risk reduction
study of efficacy and safety of vay736 in patients with pemphigus vulgaris

Conditions: Pemphigus Vulgaris

Summary: the study evaluated the efficacy, safety and pharmacokinetics of vay736 in the treatment of patients with pemphigus vulagaris (pv).

this was a non-confirmatory, randomized, partial-blind, placebo-controlled trial evaluating the efficacy, safety and pharmacokinetics (pk) of vay736 in the treatment of pv patients. a total of 13 patients were enrolled and randomized into the study. of these 13 patients,seven were randomized to the 3 mg/kg vay736 group, two were randomized to the 10 mg/kg vay736 group and four were randomized to the placebo group.in the placebo group, three out of the four patients consented to open-label vay736 treatment and received 10 mg/kg vay736 after week 24 onwards. thus, a total of 12 patients received vay736, 7 patients received 3 mg/kg and 5 patients 10 mg/kg. the screening period consisted of a screening visit performed within 28 days prior to randomization to assess patient eligibility. following screening, patients underwent pre-dose procedures which included assessment of their pv by pemphigus disease area index (pdai), autoimmune bullous skin disease intensity score (absis) and investigator global assessment (iga), and blood sampling for pk endpoints. patients then received the study drug, which was administered over approximately a 2 hour period. the patients remained in the study center overnight post-infusion for observation and for measurement of safety parameters and pk samples approximately 24 h post-infusion (start of infusion: ±2 h). patients were then discharged from the study site and returned as per the schedule. patients were evaluated at week 1, week 2 and week 3, then every 3 weeks through to week 12, and every 4 weeks through to week 24. at week 24, the blind was broken to confirm treatment allocation. if a patient was on placebo, such patient completing the week 24 visit and after unblinding had the option of receiving open label vay736 10mg/kg. recruitment was paused in mar-2015 and at the time 13 patients were enrolled. the study recruitment was then terminated in dec-2015 for strategic reasons related to the development of the compound.

Eligibility criteria:
inclusion criteria: * adult patients 20 to 70 years of age * confirmed diagnosis of pemphigus vulgaris * presence of mild to moderate pemphigus vulgaris * patients must weight between 40 kg and 150 kg inclusive * on a stable dose of oral corticosteriod therapy (with or without azathioprine or mycophenolate) exclusion criteria: * pregnant or nursing (lactating) women * women of child-bearing potential unless they are using a highly effective method of birth control during dosing and for 4 months following study treatment * recent previous treatment with photo therapy, biological therapy, steroids, immunosuppresive agents (unless washout period applied) * active or recent history of clinically significant infection * use of rituximab within 1 year other protocol-defined inclusion/exclusion criteria may apply.

Keywords: pemphigus vulgaris pemphigus blistering disease
transcranial direct current stimulation and antisocial behavior

Conditions: Aggression

Summary: the main objective of this study is to investigate the causal relationship between prefrontal cortex activity and antisocial behavior, as well as risk factors for antisocial behavior. specifically, this study tests the hypothesis that upregulating activity in the prefrontal cortex through a non-invasive form of brain stimulation, transcranial direct current stimulation (tdcs) will reduce antisocial and aggressive behavior. the effects of 3 days of anodal stimulation over the prefrontal cortex are assessed.


Eligibility criteria:
inclusion criteria: * above 18 (with parental consent) or above 21 (without parental consent) * able to understand the nature of the study and give informed consent exclusion criteria: * history of or active neurologic, cardiovascular, or psychiatric disease including anxiety disorders (e.g., ptsd, panic attacks, obsessive-compulsive disorder) and mood disorders (e.g., depression) * currently consuming anti-convulsant, anti-psychotic, or sedative/hypnotic medications * currently consuming anti-depressants * history of seizures * metallic implants on scalp * participated in any other non-invasive brain stimulation study in the same day * ever had an adverse reaction to tdcs

Keywords: transcranial direct curren stimulation antisocial behavior
combining oral letrozole and clomiphene for ovarian stimulation (cool-cos) associated with corifollitropin alfa: a pilot study

Conditions: Infertility

Summary: this is a pilot study evaluating the effect of a simplified low-cost (friendly) controlled ovarian stimulation using clomiphene citrate, letrozole, and corifollitropin alfa on the number of oocytes retrieved.


Eligibility criteria:
inclusion criteria: * women scheduled to controlled ovarian stimulation for oocyte retrieval. * body mass index between 18 and 35 kg/m2. * ultrasound scan up to the third day of a menstrual cycle with absence of a dominant and active follicle (follicle \>10mm and serum estradiol ≥ 40 pg/l). * signing an informed consent. exclusion criteria: * none
motor attention training for attention deficit hyperactivity disorder (adhd)

Conditions: Attention Deficit Hyperactivity Disorder

Summary: the investigators will perform a feasibility/pilot trial of two non-pharmacological interventions for adhd in college students.

college students diagnosed with adhd will be randomized to three arms of approximately 8 weeks duration: (1) standard care plus a tai chi class, (2) standard care plus an exercise class, and (3) standard care alone. the exercise class will control for the social and motor components of tai chi training. the investigators will determine methodological parameters relevant to a subsequent full scale trial including recruitment and retention rates, acceptance of randomization, adherence to the interventions, and variance in outcome measures. the primary clinical outcome measure of this pilot randomized controlled trial (rct) will be pre- to post-intervention change in inattention, i.e. the inattentive symptoms subscale of the conners adult adhd rating scale self-report long form (caars-s:l, see interviews etc. "converse_s_l"). secondary measures to be explored will include self- and informant-report, neurocognitive measures, psychophysiological measures, and academic performance. practice time will be assessed daily and follow-up self-report of adhd symptoms will be gathered monthly for 3 months beyond the end of the intervention.

Eligibility criteria:
inclusion criteria: * university of wisconsin-madison enrolled undergraduate * documented adhd diagnosis exclusion criteria: * unable or unwilling to participate in the interventions

Keywords: motor attention training exercise tai chi adhd