Kornimate/medical-research-clean huggingface dataset:
an observational study to assess change in disease activity and treatment patterns of upadacitinib when given alone or co-administered with methotrexate in adult participants with active psoriatic arthritis

Conditions: Psoriatic Arthritis

Summary: psoriatic arthritis (psa) is a chronic, immune-mediated, systemic disease affecting less than 1% of people with variations by parts of the world, and around 20%-30% of participants with psoriasis. upadacitinib (rinvoq) is approved drug for the treatment of adult participants with active psa in europe. approximately 450 adult participants who are prescribed upadacitinib by their physician in accordance with local label will be enrolled in 4 countries in europe: france, germany, greece and italy. participants will receive upadacitinib as prescribed by their physician according to their routine clinical practice and local label. participants will be followed for up to 24 months. there is expected to be no additional burden for participants in this trial. participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of active psoriatic arthritis (psa) whose peripheral involvement justifies the prescription of upadacitinib upon judgement of the treating physician. * physician decision on participant treatment with upadacitinib must have been reached prior to and independently of recruitment in the study. * upadacitinib prescribed in accordance with the applicable approved label and local regulatory and reimbursement policies. * participants able to understand and communicate with the investigator and comply with the requirements of the study. exclusion criteria: * participation in a clinical trial of an investigational drug, concurrently or within the last 30 days. * prior treatment with upadacitinib.

Keywords: psoriatic arthritis psa upa upadacitinib rinvoq®
the impact of cancer on the physical and psychosocial well-being among childhood osteosarcoma survivors

Conditions: Childhood Osteosarcoma

Summary: the aim of the study is to examine the impact of cancer and treatment-related effects on the physical and psychosocial well-being and quality of life among hong kong chinese survivors of childhood osteosarcoma.

osteosarcoma is the most common primary malignant bone tumor in children and adolescents. the 5-year overall survival rates of childhood osteosarcoma survivors have been increasing substantially with a percentage approaching to 70%. regrettably, the improved survival rates may lead to long-term sequelae related to disease and treatments that can negatively affect survivors' physical and psychological well-being. despite numerous studies have examined the impact of cancer and treatment-related late effects on the physical and psychological aspects of osteosarcoma survivors in the foreign countries, it has not been studied specifically in hong kong chinese population. problems arise when there is a difference in perception and recognition of psychological problems and emotional well-being between western and chinese culture. moreover, the difference in coping strategies between chinese and western children also affects how they react and cope with the devastating effect from cancer and its treatments. due to the cultural and belief differences, the findings from those studies in the foreign counties may not be applicable and transferable in hong kong context. there is thus an imperative need to investigate the impact of cancer and treatment-related effects on the physical and psychosocial well-being and quality of life among hong kong chinese survivors of childhood osteosarcoma in order to raise awareness of the holistic wellness of osteosarcoma survivors.

Eligibility criteria:
inclusion criteria: * hong kong chinese under the age of 30 years at the time of study participation; * diagnosed with osteosarcoma under the age of 19 years; * completed the entire course of treatment at least 5 years; * able to speak fluent cantonese and read chinese. exclusion criteria: * survivors with secondary malignancy, organic cause psychosis, cognitive or learning problems, or under active cancer treatment
compare the efficacy and safety of ql0605 injections at different timepoints

Conditions: Chemotherapy-Induced Febrile Neutropenia

Summary: the goal of this real-world study is to compare the efficacy and safety of ql0605 administered 24 hours and 48 hours after chemotherapy in breast cancer patients.

patients with stage invasive breast cancer who were scheduled to receive at least 2 cycles of adjuvant or neoadjuvant chemotherapy with tac/tc/tcbh regimen were eligible for this multicenter, open-label, randomized trial. patients were randomized (2:1) to receive ql0605 24 hours (24h group) or 48 hours (48h group) after the end of each cycle of chemotherapy. the primary endpoint was the incidence rate of fn for cycle 1. the secondary endpoints included the incidence rates of grade 3/4 neutropenia, chemotherapy dose reduction and chemotherapy delay due to neutropenia, antibiotic administration, the pain (bone, muscle, or joint), ect.

Eligibility criteria:
inclusion criteria: * aged≥18 years； * the expected survival period is more than 3 months; * ecog≤ 2; * invasive breast cancer diagnosed by histopathology; * plan to receive tac, tc or tcbh chemotherapy; * subjects with good hematology, liver, lung and kidney function ; * signed informed consent. exclusion criteria: * known hypersensitivity to rhg-csf or peg-rhg-csf; * female patients during pregnancy or lactation; * the previous malignant tumors were not cured; * received chemotherapy or radiotherapy within 4 weeks before screening; * received peg-rhg-csf within 6 weeks before screening; * suffering from uncontrollable infectious diseases within 2 weeks before screening.

Keywords: febrile neutropenia, breast cancer, chemotherapy
phototherapy combination with topicals in vitiligo

Conditions: Vitiligo, Generalized

Summary: patients will be included in a randomized controlled clinical trial, will enroll only adult vitiligo patients with surface area of at least 10% who are being followed in the outpatient dermatology clinics of king abdullah university hospital (kauh) and are planned to start on phototherapy narrow band ultraviolet light b (nbuvb), regardless if they have previous treatment for their disease, one month wash off period will be given for patients who are already on phototherapy or other treatments for vitiligo.

patients to be included in this randomized controlled study are adults with generalized vitiligo of surface area of at least 10% who are being followed in the outpatient dermatology clinics of king abdullah university hospital (kauh) and are planned to start on phototherapy narrow band ultraviolet light b (nb-uvb), regardless if they have previous treatment for their disease, one month wash off period will be given for patients who are already on phototherapy or other treatments for vitiligo. in our going study, adult patients will be enrolled into 2 groups ( around 20 patients per each) in which nbuvb will be given 2-3 sessions per week in combination with one of the following randomly; one group will start on tacrolimus 0.1% ointment twice daily, a second group will start on calcipotriol \& betamethasone containing cream once daily, photos will be taken and the exact sites involved will be detected, efficacy of treatment will be assessed according to repigmentation percentages of vitiligo areas from baseline at 3 and 6 months. the improvement at 6 months compared to baseline will be classified into 5 groups according to the percentage of repigmentation as follow; excellent (76%-100%); moderate (51%-75%); mild (26%-50%); minimal (1%-25%); or no response.

Eligibility criteria:
inclusion criteria: * adult patients ( ≥ 18 years). * diagnosed with vitiligo clinically and by using wood's light * generalized type vitiligo and bsa ≥ 10% * planned by his physician to start on phototherapy * wash off period for patients on treatment of one month duration. exclusion criteria: * children less than 18 year old * localized type vitiligo or bsa less than 10% * unable to do phototherapy * pregnant women with vitiligo * previously failed to response to phototherapy
evaluation of the safety and tolerability of exogenous ketosis induced by free beta-hydroxybutyrate.

Conditions: Exogenous Ketosis

Summary: the goal of this clinical trial is to evaluate the safety and tolerability of free beta-hydroxybutyrate induced ketosis in healthy individuals. the main question it aims to answer is: * is free beta-hydroxybutyrate safe and well tolerated by adults? participants will be asked to ingest 10 grams of beta-hydroxybutyrate, diluted in water and sweetened with stevia, every morning between 9:00 and 11:00 for four weeks.

several ketogenic interventions have shown benefits in a wide variety of clinical scenarios. ketosis can be induced in different ways: by 72 hours of fasting, with a carbohydrate-restricted diet and with supplements. for emergency situations, such as heart failure, the first two options are not an option for patients as they cannot wait 72 hours. there are 3 safe supplements for inducing ketosis: ketone salts, ketone esters and medium-chain triglycerides. even though they all raise the beta-hydroxybutyrate serum concentration, they significantly differ in safety profiles, drug vehicles, palatability and monetary costs. a biologically identical beta-hydroxybutyrate supplement with prompt onset of action and free of salt, alcohol and drug vehicles would be an adequate option in many clinical settings. a gender and age-balanced adult sample will be recruited in order to evaluate the safety and tolerability of free beta-hydroxybutyrate. participants will be asked to ingest 10 grams of beta-hydroxybutyrate, diluted in water and sweetened with stevia, every morning between 9:00 and 11:00 for four weeks. symptoms will be evaluated on a daily basis with a self-administered opened questionnaire. a venous blood gas analysis will be made at the beginning, 2 and 4 weeks later.

Eligibility criteria:
inclusion criteria: * asymptomatic adults who have not been diagnosed with chronic degenerative diseases or diseases that cause acid-base imbalances. * regarding women of childbearing age, it will only be recruited those who are using a method of contraception including oral contraception, contraceptive implant, contraceptive injection, intrauterine device (iud) or patch. * adults without cognitive impairment that can compromise decision making. exclusion criteria: * scheduled surgery during participation period. * adults on a ketogenic diet, carbohydrate-restricted diet or intermittent fasting. * women with a positive hcg serum or urine pregnancy test.

Keywords: exogenous ketosis beta-hydroxybutyrate safety tolerability ketone bodies
utilising lifemap to investigate malignant arrhythmia therapy

Conditions: Ischemic Cardiomyopathy; Sudden Cardiac Death; Implantable Defibrillator User; Myocardial Infarction; Arrhythmias, Cardiac

Summary: it is universally recognised that current methods for risk stratification of sudden cardiac death (scd) are limited. a novel scd risk marker, the regional restitution instability index (r2i2), measures the degree of heterogeneity in electrical restitution using data obtained from a standard 12 lead ecg acquired during an invasive electrophysiological study. in an ischaemic cardiomyopathy (icm) cohort of 66 patients, an r2i2 of ≥1.03 identified subjects with a significantly higher risk of ventricular arrhythmia (va) or death (43%) compared with those with an r2i2 \<1.03 (11%) (p=0.004). this study will use non-invasive techniques to acquire electrical restitution data: exercise and pharmacological stress, and will incorporate body surface potential mapping to develop a non-invasive and high-resolution form of r2i2. suitable patients will be recruited into a prospective, observational study. hypotheses: primary: 1. r2i2 is predictive of ventricular arrhythmia (va) / scd in patients with icm. 2. the exercise stress protocol will create a dynamic range of heart rates that allows ecg quantification of electrical restitution heterogeneity that correlates with invasive r2i2 and is predictive of va/scd. the pharmacological stress protocol will create a dynamic range of heart rates that allows ecg based quantification of electrical restitution heterogeneity that correlates with invasive r2i2 and is predictive of va/scd. secondary: 1. a high-resolution electrical map acquired using body surface potential mapping will correlate with r2i2 and these data can be included in the r2i2 calculation to improve its prediction of scd/va. 2. serial measurement of r2i2 will produce consistent values.


Eligibility criteria:
inclusion criteria: * age \>18 * history of ischaemic cardiomyopathy exclusion criteria: * unable to give informed consent * \<28 days since cardiac surgery or acute coronary syndrome

Keywords: action potential duration restitution ventricular arrhythmia sudden cardiac death body-surface potential mapping electrocardiogram
anti-hiv false positivity rate in pregnant women; and investigating the factors affecting this situation

Conditions: HIV Seropositivity; Acquired Immunodeficiency Syndrome; Pregnancy, High Risk

Summary: hiv virus is an etiologic agent of ( aids ) immunodeficiency syndrome . it is known that the estimated rate of transfer from mother to baby is 25% to 45%, pregnancy rate is 5-10%, pregnancy rate is 15-20% and in lactation period is 5-10%. risk factors; maternal viral load, breastfeeding, vaginal birth, and prematurity. although there is a high rate of false positivity in prenatal screening in our country, one of the factors affecting this is the number of pregnancies.


Eligibility criteria:
inclusion criteria: * anti hiv seropositive pregnant women exclusion criteria: * anti hiv seronegative pregnant women
obstetrical analgesia in the estaing hospital maternity. a prospective database to study the determinants of labor pain and the resulting maternal non satisfaction.

Conditions: Epidural Analgesia; Hospital Follow-up

Summary: there is a trend to offer personalized care in many medical domains. in the field of labor pain, it appears that maternal satisfaction about care is multifactorial, and that labor pain is only one of its determinants, competing with psychological and sociological factors. furthermore, labor pain is also multifactorial, depending on predisposition to pain, the way analgesia is conducted, and other environmental factors. we wish to develop predicting models of maternal satisfaction, in order to offer in the future a better tailored analgesia.

the observation shall be conducted at 3 major points of measurement throughout labor: 1. pre-, i.e. at the systematic visit for anesthesia, during the 3rd trimester of pregnancy. the collected variables will be: demographic, morphometric, socioeconomic, psychometric. the latter shall consist in a short questionnaire-based assessment by: hospital anxiety and depression scale, 5-points mental health inventory, life orientation scale. as soon as it will be validated, a pain sensitivity questionnaire shall be added. 2. intra-, i.e. clinical data from the anesthesia file: conduction of epidural analgesia, labor pain, drug consumption, obstetrical outcomes. 3. post-, i.e. maternal satisfaction assessed by a set of seven 11-point numerical rating scales at day2 post childbirth, along with a written short qualitative assessment. different multivariable statistical models shall be used to identify the patients profiles and the possible determinants of satisfaction: descriptive (factorial analyses) and inferential (glm or longitudinal).

Eligibility criteria:
inclusion criteria: * any parturient coming for her regular pre-partum anesthesia visit at the estaing hospital maternity exclusion criteria: * refusal of epidural analgesia at the time of the visit. * participation refusal. * inability to answer the pre- or post-partum questionnaires. * any medical condition considered as a relevant exclusion criterion by the investigator.

Keywords: epidural analgesia labor pain satisfaction care assessment psychometry
influence of lens design on particulate exchange in the post-lens tear film

Conditions: Visual Acuity

Summary: this is a 5-visit, controlled, bilateral, randomized, subject-masked, crossover (4 treatments x 4 period), non-dispensing study. subjects will attend all study visits in their spectacle correction having not worn contact lenses on the day of the visit.


Eligibility criteria:
inclusion criteria: * potential subjects must satisfy all of the following criteria to be enrolled in the study: 1. the subject must read, understand, and sign the statement of informed consent and receive a fully executed copy of the form. 2. the subject must appear able and willing to adhere to the instructions set forth in this clinical protocol. 3. the subject must be between 18 and 40 (inclusive) years of age at the time of screening. 4. the subject must own a wearable pair of spectacles and be willing to wear them to each study visit. 5. the subject must be an adapted soft contact lens wearer in both eyes, having successfully worn contact lenses in the last six months by self-report. 6. the subject must agree not to participate in other clinical research for the duration of this study. 7. the subject's refractive cylinder must be \<-1.25dc in each eye. 8. the subject must have best corrected visual acuity of 0.20 logmar or better in each eye. exclusion criteria: * potential subjects who meet any of the following criteria will be excluded from participating in the study: 1. currently pregnant or breast feeding (self-reported). 2. any systemic disease (e.g., sjögren's syndrome), infectious disease (e.g., hepatitis, tuberculosis), contagious immunosuppressive diseases (e.g., hiv), autoimmune disease (e.g. rheumatoid arthritis), or other diseases, by self-report, which are known to interfere with contact lens wear and/or participation in the study (at the investigator's discretion). 3. use of topical medication such as eye drops or ointment within 24 hours prior to the study visit. 4. any history of anaphylaxis or severe allergy. 5. any previous, or planned (during the course of the study) ocular surgery (e.g., radial keratotomy, prk, lasik, etc.) 6. participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment 7. employee or immediate family member of an employee of clinical site (e.g., investigator, coordinator, technician) 8. they have any slit lamp findings of grade 3 or higher (e.g. corneal edema, corneal neovascularization, tarsal abnormalities, conjunctival injection) or findings of \< grade 3 which in the investigator's opinion would contraindicate contact lens wear.
comparing two eccentric protocols on muscle damage

Conditions: Eccentric Hypertrophy; Muscle Damage

Summary: the purpose of this study will be to test whether a new way of weight training is more effective than typical weight training. the investigators expect that this new way will cause more exercise-induced muscle damage, which helps people build bigger muscles. another purpose of this study will be to explore perceptions of how muscle soreness impacts participant activities of daily living.

participants will come to the lab for 3 sessions, plus two email follow-up questionnaires. session 1 (45 minutes) * complete a demographic questionnaire * self-assess muscle soreness * walk on the treadmill to warm-up * maximal voluntary contraction on the chest press * two sets of eccentric (lowering) bench press at 75% of max session 2 (45 minutes) * walk on the treadmill to warm up * maximal voluntary contraction on the chest press * three sets of 10 eccentric contractions at 75% of max * repeat the maximal voluntary contraction on the chest press session 2 follow-up rate muscle soreness for each of the three days following session 2 answer open-ended questions about perceptions of the muscle soreness session 3 (45 minutes) walk on the treadmill to warm up maximal voluntary contraction on the chest press three sets of 10 eccentric contractions at 75% of max repeat the maximal voluntary contraction on the chest press session 3 follow-up rate muscle soreness for each of the three days following session 2 answer open-ended questions about perceptions of the muscle soreness

Eligibility criteria:
inclusion criteria: * sixteen young adults (ages 18-35) will be enrolled in this study. * in order to be enrolled, they must have completed at least three months of resistance training in the past five years in order to minimize the learning effect and chance of injury. exclusion criteria: * since regular resistance training reduces the primary outcomes, muscle damage and soreness, individuals who currently participate in chest press resistance training at least once per week will be excluded. * individuals who have musculoskeletal injuries in the shoulder, elbow or wrist that preclude pain-free resistance training, or who have underlying uncontrolled cardiovascular complications will also be excluded. * women who are pregnant, or may consider becoming pregnant over the subsequent 2 months, will be excluded
the efficacy of neiguan (p6 point) acupressure in patients with gastroesophageal reflux disease (gerd)

Conditions: Gastroesophageal Reflux Disease

Summary: in recent years, there is an increasing trend in the number of patients with gastroesophageal reflux disease (gerd). the poor response to medicine was noticed in patients with non-erosive reflux disease. according to the theory of traditional chinese medicine, acupuncture neiguan (p6 point) could improve the uncomfortable symptoms of the chest and upper abdomen. therefore, the aim of this study is to investigate the clinical efficacy of neiguan (p6 point) acupressure in patients with gerd.

in recent years, there is an increasing trend in the number of patients with gerd. gerd mainly related to the reflux of stomach content induced by the dysfunction of lower esophageal sphincter. the common symptoms of gerd are heartburn, acid regurgitation, and chest pain. the methods to treat gerd are changes of lifestyle, pharmacotherapy, antireflux surgery and endoscopy. however, the poor response to medicine was still noticed in patients with non-erosive reflux disease. and long-term use of medicine will result in many side effects including infectious, abdominal pain, diarrhea and osteoporosis. according to the theory of traditional chinese medicine, acupuncture neiguan (p6 point) could improve the uncomfortable symptoms of the chest and upper abdomen. therefore, the aim of this study is to investigate the clinical efficacy of neiguan (p6 point) acupressure in patients with gerd. 64 patients with gerd were randomly divided into two groups：the acupressure and control. in the acupressure group, in addition to receiving standard treatment, patients will band a hand ring over neiguan (p6 point) and acupressure for seven days. in the control group, in addition to receiving standard treatment, patients will band a hand ring but no acupressure for seven days. data was collected by self-recorded symptoms before and after the intervention, according to the reflux disease questionnaire(rdq) and the world health organization quality of life questionnaire taiwan condensed version. data was analyzed by student's t-tests, paired student's t-test, chi-square, and fisher exact tests for quantitative and qualitative variables. we anticipate the treatment of neiguan (p6 point) acupressure will reduce the symptoms of gastroesophageal reflux and improve the quality of life.

Eligibility criteria:
inclusion criteria: 1. male or female 2. age of 20-60 years 3. suffered from heartburn with or without acid regurgitation exclusion criteria: 1. suffered from peptic ulcer, gallstones, cancer, and barrett's esophagus 2. previously underwent the esophagus, stomach or duodenum surgery 3. lactating women or pregnant women 4. patients with severe cardiovascular disease

Keywords: gerd neiguan acupressure p6