Kornimate/medical-research-clean huggingface dataset:
zidovudine plus lamivudine in htlv-i-associated myelopathy: a randomised trial

Conditions: HTLV-I-associated Myelopathy

Summary: to determine whether the use of two antiviral agents in combination will be better than placebo in the treatment of an inflammatory sidease of the spinal cord caused by htlv-i

randomised, double-blind, placebo-controlled two centre study of zidvoudine plus lamivudine in ham/tsp 24 patients randomised 1:1 2-4 week lead-in 6 months randomised phase followed by 6 months open-label therapy with active drug primary endpoint: clinical secondary endpoints: virological and immunological

Eligibility criteria:
inclusion criteria: * htlv-i-associated myelopathy exclusion criteria: * prior exposure to zidovudine or lamivudine on disease modifying therapy * under age 16

Keywords: ham/tsp htlv-i-associated myelopathy zidovudine lamivudine antiretroviral therapy
sertraline pediatric registry for the evaluation of safety (sprites)

Conditions: Obsessive Compulsive Disorder

Summary: to evaluate the long-term impact of treatment with sertraline on aspects of cognitive, emotional and physical development and pubertal maturation in pediatric subjects ages 6 to 16 years (inclusive) with a diagnosis of anxiety disorder, depressive disorder or obsessive compulsive disorder.

purposive sample: patients are not randomly selected, that is, he or she must meet certain inclusion criteria in order to qualify as a potential study participant.

Eligibility criteria:
inclusion criteria: * children age 6 to 16 (inclusive) with anxiety, depression, or obsessive-compulsive disorder, receiving treatment in outpatient setting, and who are prescribed a new prescription for sertraline to treat one of the above study-qualifying disorders or beginning psychotherapy for same. exclusion criteria: * psychotic at study entry * diagnosis of bipolar disorder * diagnosis of schizoaffective or schizophrenia * anorexia * bulimia or eating disorder not otherwise specified (nos) * autism * pervasive developmental disorder * high risk of suicide within 2 weeks of initiating study treatment * significant mental retardation * taking an antidepressant medication other than sertraline, first or second generation antipsychotic, lithium, psychostimulant

Keywords: prospective cohort sertraline long-term impact cognition emotional and physical development pubertal maturation
a study investigating the effectiveness and safety of garadacimab for treating patients with hereditary angioedema (hae)

Conditions: Hereditary Angioedemas

Summary: this is a multinational, multicenter, prospective, observational cohort study of patients with hae in the real-world setting. the study will include patients newly initiating garadacimab in routine clinical practice. each participant will be followed for 48 months after index date (date of the first administration of garadacimab). patient data will be collected from the hae ediary, patient medical records (mrs) and/or during a routine clinical visit and will be entered into the electronic case report form (ecrf) via an electronic data capture (edc) system. data pertaining to hae attacks, prior hae treatments, retrospective focused safety data collection, and healthcare resource utilization (hcru) over a look-back period of 12 months prior to the enrollment will be extracted from the mr, and patients will also record retrospective hae attack related data over a look-back period of 3 months prior to enrollment in the hae ediary. the primary aim of this study is to investigate the real-world effectiveness of garadacimab as measured by hae attack rate before and after garadacimab initiation in patients with hae over 24 months of follow-up. the study will aim to complement the data available from the clinical development program on the efficacy, safety, and health-related quality-of-life (hrqol) in patients with hae taking garadacimab.


Eligibility criteria:
inclusion criteria: 1. participants aged greater than or equal to (\>=) 12 years at enrollment. 2. participants with clinical and/or laboratory confirmed diagnosis of hae. 3. participants newly initiating garadacimab, as prescribed according to the decision of the treating physician per routine clinical practice and in accordance with the indication per the approved local label, independent of and prior to enrollment in the study. 4. willing and able to provide written informed consent and/or assent by parent or legal guardian for children less than (\<) 18 years of age (or legal age of consent in the respective countries). 5. ability to use an electronic device such as a smartphone or a computer for data collection in the study. exclusion criteria: 1. participants with a concomitant diagnosis of another form of angioedema such as idiopathic or acquired angioedema, recurrent angioedema associated with urticaria (histaminergic angioedema). 2. participants participating in any ongoing interventional clinical study, including interventional studies with garadacimab. participants in this study who later chose to enroll in any interventional clinical study (including garadacimab) will be discontinued from this study.

Keywords: angioedema genetic disorder long term prophylaxis health-related quality of life
the system fammeal with tailored recommendations and gamification for parents to counteract childhood obesity

Conditions: Overweight and Obesity

Summary: the investigators aim to test an evidence-based intervention, allocated to a mobile app designed to parents and their children with 3 to 6 years old, identified by family doctors or nurses at well-child care visits as overweight or obese for age. this intervention aims to improve parent's perceptions and attitudes regarding children's weight status and food intake, leading to better dietary intake and children's' eating behaviors through positive parental child-feeding practices. in this study, the investigators aim to assess the feasibility of the intervention and explore its impact on the beliefs and attitudes of parents.

the investigators will enroll parents and their children with 3 to 6 years old, identified by family doctors or nurses at well-child care visits as overweight/obese for age. participant's eligibility will be assessed. participants will be randomized to: 1) control group; 2) intervention group. the control group will receive treatment as usual. parents in the intervention group will be provided with the app and invited to use it for 4 weeks. during the 4 weeks, the administrator monitors the app usage and call once to parents to improve it, if needed. both groups will perform a pre- and post-test, evaluating parent's perceptions and attitudes regarding children's weight status and food intake; eating behaviors and parental child-feeding practices.

Eligibility criteria:
inclusion criteria: * children with 36 to 83 months at the start of the intervention. * children overweight or obese for age, according to world health organization criteria. * parent/ caregiver with at least 18 years old. * parent/caregiver involved in child feeding management (≥ 5 in a 0-10 rating scale, from 'not at all' to 'extremely involved'). * parent/ caregiver able to read, speak and understand portuguese. * parent/caregiver with an android device. * parent/caregiver willing to participate in the research study, to participate in two face-to-face evaluations, to install and use the app and to receive weekly notifications and 1-3 calls, during 4 weeks. exclusion criteria: * children with any medical conditions that affect growth, intake or physical activity. * children with any dietary professional advice, in the last 6 months.

Keywords: childhood obesity nutrition mhealth parenting
pain: screen and treat

Conditions: Head and Neck Cancer; Pain

Summary: this study is looking at treating cancer pain in head and neck cancer. patients are asked in outpatients to score their worst pain on a scale of 0 to 10 in the last 24 hours. those with a pain score of 4 and above are randomised into the study. patients are allocated to continue with their current care (control group) or to be reviewed by the pain/palliative care team (intervention group). at baseline questionnaires are completed on level of pain, type of pain, quality of life and anxiety/depression. information is also collected on the analgesia they've used in the past month and basic health economics (gp/hospital visits related to pain management and treatment). follow up in the trial is for 3 months and consists of questionnaires as above and further collection of information on analgesic usage and health economics.


Eligibility criteria:
inclusion criteria: * patients attending head and neck oncology clinics * patients with a cancer diagnosis who are receiving anti cancer treatment or who have received anti cancer treatment * patients who score 4 or more on the brief pain inventory numerical rating scale screening question 'worst pain in past 24 hours' exclusion criteria: * age below 18 years * patients unable to respond to an english written assessment * patients with medical conditions that could affect their mental function or level of consciousness such as stroke, or dementia * patients who score \<4 on the brief pain inventory numerical rating scale screening question * patients already under the care of a pain/palliative care service
an evaluation of the effectiveness of local anesthetics used during intravenous catheter insertion

Conditions: IV Insertion Pain

Summary: the purpose of this study is to compare how well different anesthetic, or numbing, solutions injected under the skin work in reducing the discomfort associated with placing a catheter in a vein. two different medications, lidocaine and normal saline with benzyl alcohol, have been found to be effective in reducing discomfort when injected under the skin just prior to inserting the catheter. this study compares these two solutions, and will compare the discomfort that occurs both with and without using these solutions.


Eligibility criteria:
inclusion criteria: * adult patients (aged 18 or older) * admitted to a general medical or surgical unit at durham regional hospital (drh) * have a physician's order for an iv * are able to speak, read and understand english * referred to the vascular access specialty team (vast) at drh for iv catheterization exclusion criteria: * admission to the emergency room, pre-op unit, an outpatient unit, a psychiatric unit, an intensive care unit, a pre- or postnatal care unit, or labor and delivery units; * history of a psychological disorder, as determined from the patient's chart; * history of peripheral neuropathy, as determined by patient's chart; * history of iv drug abuse, as determined from the patient's chart; * decreased sensation in the arm or hands, as reported in the chart or by the patient; * patient disorientation or confusion (i.e., unable to state person, place, time or unable to comprehend instructions for completing visual analog scale); * a known allergy to lidocaine or benzyl alcohol as determined from the patient's chart; * veins that cannot be palpated and are difficult to visualize by vast nurses; * pregnancy; * an order for the emergency insertion of an iv by the patient's doctor or assigned nurse; * an iv insertion that requires the use of a catheter gauged 18 or larger * severe vision impairment, as determined by the patient's inability to read the visual analogue scale

Keywords: local anesthesia intravenous catheter
identification of genetic polymorphism related to acute kidney injury after liver transplantation through genome-wide association study (gwas) in korean population

Conditions: The Recipients Undergoing Liver Transplantation

Summary: some of the liver transplantation recipients experience postoperative acute kidney injury due to various causes including genetic factors. prevention of postoperative acute kidney injury is essential for postoperative care in liver transplantation recipients. the aim of this study is to investigate the relationship between gene polymorphisms and the occurrence of acute kidney injury after liver transplantation by performing genome-wide association study (gwas).


Eligibility criteria:
inclusion criteria: 1) adult patients scheduled for liver transplantation exclusion criteria: 1. patients on dialysis 2. patients not able to read, or understand the consent form 3. ethnicity, other than asian 4. patients refusal

Keywords: gene polymorphism acute kidney injury liver transplantation
erector spinae plane block reduces postoperative pain following laparoscopic colorectal operation

Conditions: Postoperative Pain

Summary: the goal of this study is to evaluate the effect of ultrasound guided erector spinae plane block on postoperative pain and quality of recovery after laparoscopic colon surgery.

.the goal of this study is to evaluate the effect of ultrasound guided erector spinae plane block on postoperative pain and quality of recovery after laparoscopic colon surgery.

Eligibility criteria:
inclusion criteria: * aged between 20 and 70 years, with an american society of anesthesiologists physical status of 1 or 2, who were scheduled for laparoscopic colorectal operation exclusion criteria: * sensitivity to local anesthetic, bleeding disorders , receiving anticoagulant, body mass index (bmi) over 35/kg/m2 spine or chest wall deformity pregnancy tolerance to opioid analgesics inability to use patient-controlled analgesia (pca)
single lumen needle without flushing or double lumen needle with follicle flushing in oocyte retrieval

Conditions: Oocyte Retrieval

Summary: the aim of this study is to compare whether oocyte flushing during retrieval is effective or not.

in total 300 patients will be randomized for the effectiveness of single or double lumen needle during oocyte retrieval. double lumen needles give an opportunity of washing to the follicle with flush. single lumen needles seem to be faster and no need for flushing. we aim to compare to the differences of the use of both needles.

Eligibility criteria:
inclusion criteria: * patients undergoing ivf/icsi cycles. exclusion criteria: * poor responder patients who have lower than 6 follicles at hcg administration day. * patients having over 30 follicles.

Keywords: follicle flushing oocyte retrieval needle
stapled transanal rectal resection (starr): clinical and radiological outcome

Conditions: Obstructed Defecation Syndrome (ODS)

Summary: to evaluate the correlation between clinical and radiological outcome after stapled transanal rectal resection (starr)


Eligibility criteria:
inclusion criteria: * \> 18 years * clinical signs of ods with prior not effective conservative treatment * anterior rectoceles and/or intussusceptions in mr-defecography exclusion criteria: * \< 18 years * fixed enteroceles * severe fecal incontinence * external rectal prolapse * anismus
real life evaluation of rheumatoid arthritis in canadians taking humira

Conditions: Moderate-to-severe Rheumatoid Arthritis

Summary: the purpose of this study is to evaluate the clinical effectiveness and safety of adalimumab as used in routine clinical practice in adult participants with moderate to severe rheumatoid arthritis (ra) in canada.

reach is an observational survey of participants with moderate to severe rheumatoid arthritis taking adalimumab. participants who volunteer will be asked to provide information about their medical history and experiences with adalimumab. no drug will be provided as a result of participation in the registry. all treatment decisions are independent of participation in the registry.

Eligibility criteria:
inclusion criteria: * participant is eligible to take part in the registry as per the product monograph. * participants that are naïve to adalimumab therapy / or participants that have been receiving adalimumab therapy for less than 4 months. * participant has moderately to severely active ra. * participant who has had an inadequate response to one or more disease modifying anti-rheumatic drugs (dmards). * participant received provincial or private (insurance companies) approval for adalimumab. * participant is able to give written informed consent and to understand the survey requirements. exclusion criteria: * participant to whom a traditional dmard had never been tried. * participant with a known hypersensitivity to adalimumab, or any of its components. * participant is receiving free adalimumab as part of a compassionate program or an early access drug distribution program. * participant with clinically significant concurrent medical or psychiatric disorders that may influence survey outcomes. * participant with any condition that would prevent participation in the survey and completion of the survey procedures including language limitation or possibility that the participant will not be available for a period of time (\> 12 months) while being enrolled in the survey.

Keywords: moderate rheumatoid arthritis rheumatoid arthritis severe rheumatoid arthritis adalimumab clinical effectiveness
sedation during spinal anesthesia

Conditions: Sedation During Spinal Anesthesia

Summary: patients during spinal anesthesia should be sedated.

spinal anesthesia offers a number of advantages to both the patient and the physician. however, patients are often reluctant to remain awake during a procedure. sedation has been shown to increase patient satisfaction during regional anesthesia and may be considered as a means to increase the patient's acceptance.therefore, provision of adequate sedation is important if the advantages of spinal anesthesia are to be fully appreciated.

Eligibility criteria:
inclusion criteria: * male patients aged from 18 to 50 years old undergoing elective unilateral inguinal hernia repair with no neurological, cardiovascular and hepato-renal abnormalities. exclusion criteria: * age: younger than 18 or older than 50. * psychatric or neurological disorders. * cardiovascular disorders. * coagulation disorders. * contraindications to neuraxial block (allergy to l.a, peripheral neuropathy, prior spine surgery).
effects of pulsed-dyed laser on scar formation

Conditions: Scars

Summary: the purpose of this study is to identify changes in color, thickness, and stiffness, of scars from skin grafting after burns when treated with a pulsed-dyed laser.

pulsed-dyed lasers have been used in the past to treat scars from minor surgery as well as burns. the laser has been used at different times, close to injury or late after injury. success or failure of the laser has been judged by subjective observer scales. in this study we will treat the seams of 1/2 of a skin graft with a pulsed-dyed laser, beginning about one month after surgery. we will use objective measures of color (redness on digital pictures), scar volume(via laser scanning), and elasticity(measured by btc-2000) as well as subjective assessment by an independent observer and the patient.

Eligibility criteria:
inclusion criteria: * \> 9 years old * not pregnant * new skin graft to extremity * able to follow simple instructions exclusion criteria: * age less than 9 years * pregnancy * any behavior pattern that would lead to conclusion that patient may not reliably follow simple instructions

Keywords: scars late effect of burn burn pulsed-dye laser
effect of a physical activity program on the hormonal regulation of food intake

Conditions: Obesity

Summary: the primary purpose of this protocol is to assess the hormonal regulation of satiety by an intense exercise before and after a 3 month physical activity program. hormones assessed are: leptin, grhélin, cholecystokinin, glucagon-like-peptid-1 (glp-1), pyy. it is well known that in overweight adults and children also, an intense physical exercise diminish the food intake relatively to the total energy expenditure and this effect is persistent after a 6 weeks physical activity program. our hypothesis are: a diminution of food intake after the intense physical exercise and a persistent diminution of food intake after the 3 month physical activity program, an augmentation of levels of glp-1 and pyy during the intense exercise before and after the physical activity program, a diminution of the level of glp-1 and leptin before and after the physical activity program

there is two sequences, one before and one after the physical activity program. each sequence contains one "rest" session and one "exercise" session. each session contains : blood sample at regular interval (leptin, ghrélin, cck, pyy, glp-1), a sleeping assessment (pittsburg scale), an assessment of hunger sensations at regular interval, an assessment of food intake in a "ad libitum" lunch and in the diner indirectly by the su.vi.max. tool. during the " rest " session : blood samples, assessment of hunger sensation, assessment of food intake are realized during the morning. physical condition (vo2 max, dexa, and muscular test), insulin-sensibility, lipid profile, are also assessed. during the "exercise" session: it is identical to the first session but an intense exercise of 40 minutes is realized at 70% of the patient's vo2 max. the peripherical blood output is measured by a non-invasive method: the near-infra-red-spectroscopy, during the exercise. the 3-months-physical activity program : there is 4 sessions of 30 minutes and 2 sessions of 1 hour per week. most of exercises sessions are realized at home but one 1-hour session per week is controled with a sports educator.

Eligibility criteria:
inclusion criteria: overweight adolescents (over the 90 th percentile of the international cut-off point) * with a computer and an internet connection * sedentary (according to the ipaq-a questionnaire) * without eating disorders (according to the debq questionnaire) exclusion criteria: * medical or surgical antecedents that are incompatible with the study: cardiovascular, endocrine or digestive disease. * drugs that could interfere with the results of the study * surgical intervention in the 3 months * regular consumption of tobacco or alcohol * patients on a diet with caloric restriction * refusal to sign the consent form * regular practice of sport and intensive

Keywords: obesity appetite regulation hormones adolescents exercise