Kornimate/medical-research-clean huggingface dataset:
evaluation of tolerability, efficacy and adherence to treatment with wynzora cream

Conditions: Psoriasis

Summary: the primary objective is to assess with the ppq questionnaire the patient preference for wynzora compared with therapy carried out previously with enstilar spray foam. secondary objectives assess satisfaction with the treatment. assess adherence to therapy. evaluate the impact of various clinical and demographic factors on treatment adherence. evaluate the efficacy of wynzora cream therapy.


Eligibility criteria:
inclusion criteria: * patients older than 18 years of age, of either sex; * patients diagnosed with mild-to-moderate psoriasis (pasi and bsa \&lt;10) requiring monotherapy topical with wynzora; * patients who have stopped treatment with enstilar foam for any reason for at least 30 days; and * patients whose medical records are accessible and record all demographic parameters, anthropometric and clinical parameters during the treatment period * signature of written informed consent; exclusion criteria: * patients with palmoplantar, inverse, erythrodermic, guttate, and scalp psoriasis. * patients who are taking concomitant systemic therapies for psoriasis, such as. cyclosporine, methotrexate, acitretin, phototherapy or biologic therapies. * women who are pregnant or planning to become pregnant. * patients with disabilities or other motor problems that could complicate self-medication.
effects of ocular electroacupuncture on trochlear nerve palsy

Conditions: Trochlear Nerve Palsy

Summary: the purpose of the study is to testify the efficacy of treating trochlear nerve palsy with ocular electroacupuncture or ocular acupuncture, and to compare the efficacy between these two interventions.

the purpose of the study is to testify whether ocular electroacupuncture or ocular acupuncture is effective for trochlear nerve palsy (tnp), through treating tnp patient for 6 weeks, using self-invented acupoints according to anatomy of extraocular muscles innervated by trochlear nerve, and using sham acupuncture as controlled group, and try to provide clinical evidence for promoting these new techniques.

Eligibility criteria:
inclusion criteria; 1. patient with confirmed diagnosis of trochlear nerve palsy made by neurologist or ophthalmologist; 2. patient in stable condition after treatment for primary disease; 3. age between 18 to 80 years old without gender limitation; 4. haven't received acupuncture intervention for tnp before; 5. patient with conscious, willing to cooperate and voluntarily agreed to participate and signed informed consent forms. exclusion criteria: 1. those with other diagnosed medical conditions known to contribute to tnp symptoms, such as thyroid disease, myasthenia gravis, mitochondrial myopathy, congenital strabismus or received strabismus surgery; 2. those with color blindness, dyschromatopsia or abnormal retinal correspondence couldn't complete computerized diplopia test; 3. those with serious medical conditions that might limit their participation; 4. those with eye or other location with serious infections; 5. women who had a positive pregnancy test or who were planning to become pregnant during the study period; 6. those with bleeding tendency, blood coagulation dysfunction or taken anticoagulant drugs; 7. who had participate in other clinical trials, which may affect the results.

Keywords: electroacupuncture trochlear nerve palsy eyeball movement diplopia ocular motility disorder
comparison of two treatments for post-traumatic stress disorder

Conditions: Post-Traumatic Stress Disorder

Summary: this study will compare the short- and long-term effectiveness of two different treatments for people with post-traumatic stress disorder.

exposure to traumatic events, such as automobile accidents and assault, can cause individuals to develop persistent psychological difficulties such as post-traumatic stress disorder (ptsd). ptsd is an anxiety disorder characterized by avoidance, hyperarousal symptoms, and mental re-experiencing of the traumatic event. ptsd is a serious condition that may cause social and psychological impairment; therefore, safe and effective treatments are needed. both cbt and antidepressant therapy have been shown to effectively treat ptsd symptoms; however, comparisons of the treatments are limited. this study will compare the short- and long-term effectiveness of cbt and the antidepressant sertraline. participants will either be randomly assigned to cbt or sertraline, or they will be able to choose one of the two treatments, which will be given for 10 weeks, followed by 24 months of follow-up assessments. participants in the cbt group will have 10 weekly sessions of therapy. during the therapy sessions, participants will be encouraged to confront their general fears and the memory of their trauma through repeated storytelling. participants will also be encouraged to practice the techniques learned in therapy in everyday life. participants in the antidepressant group will take sertraline daily for 10 weeks. these participants will be seen weekly by a psychiatrist who will offer general encouragement and support, monitor response to medication, and record any side effects participants may be experiencing. the medication may be adjusted according to a dosing schedule and based on the study doctor's judgment. at the end of 10 weeks, participants in the antidepressant group will have the choice of either tapering the medication gradually to minimize the chance of withdrawal symptoms or staying on the medication for up to 24 months. participants who do not respond to their assigned or chosen treatment will be offered the other treatment for 10 weeks. self-report scales and questionnaires will be used to assess participants' ptsd symptoms, depression, anxiety, and social functioning. these assessments will occur at 3, 6, 12, and 24 months after the study treatment period.

Eligibility criteria:
inclusion criteria: * dsm-iv diagnosis of ptsd * experienced traumatic event at least 12 weeks prior to study entry * willingness to discontinue current cbt or antidepressant treatment exclusion criteria: * current diagnosis of schizophrenia or delusional disorder * medically unstable bipolar disorder, depression with psychotic features, or depression requiring psychiatric treatment * current diagnosis of alcohol or substance dependence within 3 months prior to study entry * ongoing intimate relationship with the perpetrator of the traumatic event * history of nonresponse to either cbt or sertraline * medical contraindication for sertraline

Keywords: antidepressants cognitive behavior therapy
correlation between postoperative cognitive dysfunction and telomere length in patients with non-cardiac surgery

Conditions: Postoperative Cognitive Dysfunction

Summary: to study on the postoperative cognitive dysfunction: correlations with leukocyte telomere length。


Eligibility criteria:
inclusion criteria: * non-cardiac surgery patients; * age is greater than or equal to 65 years old; * han nationality, mother tongue is chinese; ④the mmse score:illiteracy is greater than or equal to 17 points, primary school is greater than or equal to 20 points, higher secondary school is more than 24 points; ⑤the geriatric depression scale (gds) grade 1 or 2; ⑥the important function without serious heart, brain, liver, kidney, lung and other organs; * the asa class i or ii; * the people signed informed consent. exclusion criteria: * the diagnosis of neurological and psychiatric disorders, such as alzheimer's disease, parkinson's syndrome, multiple sclerosis, schizophrenia, depression, etc.; ②had severe head and face disease, trauma history or history of surgery; * had a history of influenza in 3 weeks; ④the serious body disease and tobacco, wine and other substance abuse history; ⑤the presence of malignant tumor with shorter survival disease.

Keywords: postoperative cognitive dysfunction leukocyte telomere length
sodium oxybate versus midazolam for comfort sedation

Conditions: Palliative Care

Summary: the study aims at deepen the proof level of sodium oxybate use for comfort sedation at the end of life in a palliative care unit by comparing it to midazolam in a prospective randomized study with blinded efficacy evaluation. the study will be carried out for a period of 24 months with a recruitment objective of 22 patients with refractory suffering and with a short-term prognosis.

in certain cases, terminally-ill patients may show persistent symptoms despite numerous efforts to find a comfort treatment without causing impaired consciousness. in these cases and after a collegial discussion, sedation may be offered. midazolam is then the most typically used sedative agent. however, it has limitations: frequent awakenings, tolerance and major respiratory depression. furthermore, the use of midazolam as a "gold standard" in palliative sedation at the end of life falls under expert consensus without a high level of evidence. sodium oxybate (gammaoh®), is an ancient molecule used in anesthesia and other medical fields. it appears to be an attractive alternative to midazolam. study hypothesis is as follows: deep sedation induced by sodium oxybate (rass: -4 or -5) is more constant and sustainable than by using midazolam which can cause fluctuating effects and requires frequent dosage adjustments. the single-blind clinical trial aims at comparing the possibility to obtain constant deep sedation using midazolam or sodium oxybate. before the induction, the patient is not aware of the medication used. the medical team must be aware of it because the two administration procedures are too different.

Eligibility criteria:
inclusion criteria: * patient hospitalized in a palliative care unit * patient aged 18 or over * patient with an estimated vital prognosis of a few hours to a few days\* * patient with persistent suffering despite optimal palliative care\* * patient gave informed consent in advance or if unable to do so, consent given by a family member or legal representative (patients under guardianship) * patient covered by a social security scheme. \* validated after collegial and multidisciplinary discussion including the opinion of a doctor outside the palliative care team. exclusion criteria: * contraindication or known allergy to sodium oxybate or midazolam * significant risk of seizure * venous access not possible * pregnancy or breastfeeding * person in exclusion period from another research protocol at the time of consent signing * any condition which in the investigator's opinion could increase and jeopardize persons safety in case of research participation

Keywords: sedation end-of-life palliative care midazolam sodium oxybate
liver fibrosis in peri-menopausal women

Conditions: Nonalcoholic Steatohepatitis; Liver Fibroses; Menopause

Summary: this is a prospective observational study in a single medical center. the aim is to evaluate the status of fibrosis and steatosis of liver parenchyma in peri-menopausal women using noninvasive methods of vibration-controlled transient elastography (vcte) with controlled attenuation parameter (cap) and serum biomarkers. recruitment period: 2018/08/01 to 2019/07/31 patient number: 200 females inclusion criteria: 1. females, age of 46-55 years 2. willing and able to comply with the study requirements 3. willing and able to provide written informed consent to participate in the study exclusion criteria: 1. unable to complete the noninvasive procedure of vcet and cap 2. unwilling to provide written informed consent to participate in the study laboratory tests and examinations: baseline and two follow-up visits (every 6 months): 1. blood pressure 2. bw, bh, waist circumference, bmi 3. complete blood cell (cbc) count 4. albumin, ast, alt, alkaline phosphatase, total bilirubin, r-gt, uric acid, hscrp 5. sugar (fasting), hba1c, insulin, homa-ir 6. dm lipid profiles, adiponectin, leptin 7. liver ultrasound, fibroscan touch 520 8. fsh, estrodiol (e2), lh 9. tsh, free t4 10. hbsag, anti-hcv, hbv dna, hcv rna, hbsag quantification, hbv genotype (if hbsag or anti-hcv positive) 11. ana, anti-mitochondrial antibody 12. review history of drug and menstruation cycles


Eligibility criteria:
inclusion criteria: 1. females, age of 46-55 years 2. willing and able to comply with the study requirements 3. willing and able to provide written informed consent to participate in the study exclusion criteria: 1. unable to complete the noninvasive procedure of vcet and cap 2. unwilling to provide written informed consent to participate in the study

Keywords: nonalcoholic steatohepatitis liver fibrosis menopause hormone
to assess the level of adherence of subjects receiving saizen® via easypod™ (ecos taiwan, indonesia, singapore)

Conditions: Growth Disorders

Summary: this is an multinational, multicenter, observational study to evaluate adherence and long term outcomes of therapy in pediatric subjects using easypod™ electromechanical device for growth hormone treatment and to assess the level of adherence of subject receiving saizen® via easypod™.

subjects will be enrolled in a multicenter longitudinal observational study. parents/subjects will provide their informed consent/assent to upload their data for population-based analyses and, ultimately, clinical outcomes. adherence data will be primarily derived from the easypod™ device combined with physician data entry of outcome measures. data will be collected both retrospectively and prospectively. this will allow the establishment of adherence profiles and explore the hypothesis that patient adherence support programs improve adherence and subsequent clinical outcomes. collected data will be also analyzed in a multinational pooled analysis of comparable national studies. primary objective: • to assess the level of adherence of subjects receiving saizen® via easypod™ secondary objectives: * to describe the impact of adherence on clinical outcomes for subject receiving saizen® via easypod™ * to identify adherence subject profiling * to assess the impact of adherence on insulin-like growth factor 1 (igf1) (that is, above, below or within normal ranges)

Eligibility criteria:
inclusion criteria: * administered growth hormone via the easypod™ electromechanical device according to summary of product characteristic (smpc) * over the age of 2 years * under 18 years of age, or over 18 without fusion of growth plates * parent's or guardian's written informed consent, given before entering data into the observational study, with the understanding that the subject or parent/guardian may withdraw consent at any time without prejudice to future medical care. if the child is old enough to read and write, a separate assent form will be given as defined in the appropriate jurisdiction of each country exclusion criteria: * subjects taking growth hormone in whom growth plates have fused (that is, for taking growth hormone for it's metabolic effects) * contra-indications to saizen® as defined in the smpc * use of an investigational drug or participation in another interventional clinical study

Keywords: easypod™ saizen®
an internet-based dialectical behaviour therapy-informed skills training for reducing alcohol consumption and improving psychological distress of adult smokers.

Conditions: Smoking

Summary: 1. to determine the feasibility, acceptability, and preliminary effects of an internet-based dbt-st for promoting smoking abstinence/reduction and improving psychological distress/emotional regulation in adult smokers 2. to explore the participants' experiences and perceptions (e.g., perceived benefits/weaknesses) towards the proposed intervention


Eligibility criteria:
inclusion criteria: * hong kong chinese aged 18-64 years * had smoked at least one cigarette per day over the previous three months * indicate psychological distress as measured by the depression, anxiety, and stress scale-21 * have an intention to stop smoking * have an electronic device and are willing to receive interventions via the internet exclusion criteria: * experiencing psychotic disorders/cognitive impairment/communication problems * participating in other smoking cessation programs or related psychosocial interventions

Keywords: dialectical behaviour therapy skills training internet-based intervention psychological distress adult smokers smoking
treatment of the low igf-1 syndrome associated with chronic heart failure: a randomized, placebo-controlled, double-blind study.

Conditions: Chronic Heart Failure

Summary: the objective of the study is to determine whether treatment of the low igf-1 syndrome in patients with chf is able to modify some functional parameters, recognized as valid surrogate end-points of chf progression.


Eligibility criteria:
inclusion criteria: * patients of either sex affected by chf nyha class ii-iii, secondary to ischemic or idiopathic dilated cardiomyopathy * age range 30-80 years * stable medications for at least two months prior to randomization, including ace inhibitors or at1 antagonists and beta-blockers (unless untolerated). * lv ejection fraction 40% or less * peak vo2 consumption during a cpet ≤ 16 ml/kg/min. * lv end-diastolic dimension 55 mm or more * low igf-1 levels and a satisfactory response to an igf-1 generation test * informed consent exclusion criteria: * haemodynamic clinically significant primary valvular disease or significant congenital heart disease * acute pericarditis/myocarditis * inability to perform a bicycle exercise test * poorly controlled diabetes mellitus (hba1c \>8.5) * active proliferative or severe non-proliferative diabetic retinopathy * active and/or history of malignancy * evidence of progression or recurrence of an underlying intracranial tumor * unstable angina or recent myocardial infarction (less than 5 months) * severe liver disease * serum creatinine levels \>2.5 mg/dl * inability to cooperate or administer the study drug * patients participating in any other clinical study, within 30 days prior to screening visit and/or during this particular study period
screening for acute malnutrition

Conditions: Acute Malnutrition in Childhood

Summary: this project includes a pilot cluster-randomized trial of the efficacy of training caregivers to screen for acute malnutrition (am) in children aged 6-59 months using mid-upper arm circumference (muac) in burkina faso. the pilot will be conducted to establish the feasibility of procedures and preliminary outcome data to inform the sample size calculations and design of a future longer-term, fully powered cluster-randomized trial. forty communities enrolled in the bill \& melinda gates foundation-funded child health with azithromycin treatment (chat) trial will be randomly selected for this pilot and randomized to receive the caregiver training intervention or no additional intervention. all communities will continue to receive standard of care screening for am according to national guidelines, which includes community-based screening for am by community health workers using muac every 6 months. a baseline census will be conducted before randomization to enumerate the eligible population of caregivers and children 6-59 months old and measure muac. a final census with muac measurement will be conducted 6 months later (primary outcome). data will be collected on all children presenting to the centre de santé et promotion sociale (csps) for malnutrition to track secondary outcomes. during intervention training, we will also conduct a diagnostic accuracy study to evaluate the validity of caregiver screening by comparing the muac measurements of caregivers against the gold standard measurement of the experienced health personnel conducting the training. also during training, intervention communities will be randomized to one of two training approaches: training by caregivers or training by health agents and adherence to the protocol during follow-up monitoring visits will be compared to determine effectiveness of training.


Eligibility criteria:
cluster level: * enrollment in the chat trial * location outside of the health and demographic surveillance system (hdss) * population size \< 2000 people * verbal consent of the village leader individual level: * residence in a village participating in the chat trial * caregiver or guardian of children aged 6-59 months (for intervention training) * age 6-59 months (for muac screening and some outcome assessments) * verbal consent from caregiver or guardian
a study of tak-441 in adult patients with advanced nonhematologic malignancies

Conditions: Advanced Nonhematologic Malignancies; Carcinoma, Basal Cell

Summary: this is the first study in which tak-441 is administered to humans. the patient population will consist of adults aged 18 or older who have advanced nonhematologic malignancies and for whom standard treatment is no longer effective or does not offer curative or life-prolonging potential. following completion of the dose escalation study, patients will be enrolled as part of 2 expansion cohorts.


Eligibility criteria:
inclusion criteria: each patient must meet all of the following inclusion criteria to be enrolled in the study: * male or female 18 years or older * eastern cooperative oncology group (ecog) performance status 0 to 2 * diagnosis of a nonhematologic malignancy for which standard treatment is no longer effective or does not offer curative or life-prolonging potential * meet other clinical, radiographic or laboratory inclusion criteria as specified in the protocol * voluntary written consent exclusion criteria: patients meeting any of the following exclusion criteria are not to be enrolled in the study: * life-threatening illness unrelated to cancer * receiving other treatment (radiotherapy, antineoplastics or investigational agents) within protocol specified windows of first dose of tak-441 * patients with brain metastases who do not meet criteria specified in study protocol * known history of human immunodeficiency virus (hiv) infection, hepatitis b or hepatitis c * major surgery within 14 days before the first dose of tak-441 * infection requiring systemic therapy, or other serious infection within 14 days of the first dose of tak-441 * do not meet other clinical, laboratory or radiographic criteria as specified in the protocol
balanced propofol sedation during upper endoscopy in morbidly obese patients

Conditions: Obesity

Summary: the purpose of this study is to evaluate the safety of propofol-based, gastroenterologist-administered sedation in severely obese patients (bmi≥35) undergoing upper endoscopy. the investigators aim to test the hypothesis that it is safe to use balanced-propofol, gastroenterologist-administered sedation in obese patients.

the purpose of this study is to evaluate the safety of propofol-based, gastroenterologist-administered sedation in severely obese patients (bmi≥35) undergoing upper endoscopy. we will use changes in pulmonary and hemodynamic parameters as the primary safety measure in this study. we will compare these results in 30 non-obese patients and in 30 obese patients. the term balanced propofol sedation refers to using a low dose of propofol in combination with small amounts of an opioid and midazolam.

Eligibility criteria:
inclusion criteria: * undergoing an endoscopic esophagostroduodenoscopy (egd) * capable of providing written informed consent and willing and able to comply with all procedures of the study * adults between the ages of 18 and 85 inclusive (and of legal age to consent) * asa score of i, ii, or iii exclusion criteria: * severe acute illness that is not resolved or stabilized prior to enrollment. study entry will be based on the investigator's judgment * need for sleep or narcotic analgesic medication on a continuous basis during the proceeding 6 months * pregnancy * a history of drug addiction or alcohol abuse within the past 12 months. alcohol can be consumed in moderation. the consumption of alcohol should be within the routine pattern for the individual before the study. * a history of seizure disorder. * allergy to propofol, soy beans, or eggs. * prior history of difficult intubation. * prior history of severe complications during conscious sedation. study entry will be based on the investigator's judgment.

Keywords: propofol sedation safety obesity