Kornimate/medical-research-clean huggingface dataset:
clinical evaluation of two daily disposable lenses in sphere design

Conditions: Ametropia

Summary: this was a single-blind, interventional, prospective, direct refit, bilateral wear, fixed-sequence crossover study.

the aim of this study was to evaluate the visual performance and subjective experiences of daily disposable hydrogel lens (ddh) when compared to daily disposable silicone hydrogel lens (ddsh) after 15 minutes of daily wear each.

Eligibility criteria:
inclusion criteria: * is at least 18 years of age and has full legal capacity to volunteer. * has read and signed an information consent letter. * self-reports having a full eye examination in the previous two years. * anticipates being able to wear the study lenses for the required time of the study. * is willing and able to follow instructions and maintain the appointment schedule. * has refractive astigmatism no higher than -0.75 dc. * can be fit with the available lens parameters (sphere +8.00 to -10.00d). * can achieve binocular distance vision of at least 20/30 snellen (logmar 0.18) with the study contact lenses. exclusion criteria: * is participating in any concurrent clinical or research study. * has any known active ocular disease and/or infection that contraindicates contact lens wear. * has a systemic condition that in the opinion of the investigator may affect a study outcome variable. * is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable. * has known sensitivity to the diagnostic sodium fluorescein used in the study. * self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment. * has undergone refractive error surgery or intraocular surgery.
protection of ovarian function with goserelin acetate in premenopausal early breast cancer patients with chemotherapy

Conditions: Breast Cancer; Ovarian Function

Summary: primary objective of this study is to determine the effectiveness of goserelin acetate (zoladex) in preserving ovarian function in premenopausal women undergoing adjuvant chemotherapy for primary invasive breast cancer by documenting persistence or resumption of regular menses via menstrual history, serum fsh and e2 measurements. the secondary objectives of this study are as follows: to investigate the impact of treatment with chemotherapy with or without goserelin acetate (i.e. impact of the expectation of ovarian function preservation) on participants' quality of life (qol) by fact-es scale, and to compare safety and tolerability of study drugs in two treatment groups by evaluation of adverse events.


Eligibility criteria:
inclusion criteria: * pathologically confirmed invasive breast carcinoma * candidates for adjuvant chemotherapy for primary breast cancer * premenopausal, verified before chemotherapy is begun as satisfying both cyclic vaginal bleeding and appropriate hormone levels exclusion criteria: * previous systemic chemotherapy * pregnancy * stage iv breast cancer

Keywords: adjuvant chemotherapy breast cancer goserelin acetate ovarian function chemotherapy primary invasive breast cancer
a study to evaluate the safety of d-trans fentanyl with naltrexone in adult patients with chronic pain and who are opioid tolerant

Conditions: Chronic Pain

Summary: the primary objective was to evaluate the safety of d-trans fentanyl with naltrexone hcl system compared to the duragesic (fentanyl transdermal system) in opioid tolerant patients.

this was a multicenter, randomized, double-blind, double-dummy safety study in adult patients who required continuous opioid treatment for chronic pain. patients had to be on a stable dose of duragesic for 21 days prior to the start of the study treatment period and have completed a screening period of at least 14 days to enter this study. eligible patients were randomized (2:1) to receive the equivalent strength of d-trans fentanyl with naltrexone hcl (and placebo duragesic) or the same dose of duragesic (and placebo d-trans fentanyl with naltrexone hcl \[d-trans fentanyl with naltrexone\]) for a 15-day treatment period. if necessary, patients could be titrated to higher or lower doses during the 15-day treatment period. each system was worn for 72 hours then replaced by a new system until the end of the 15-day treatment period. patients were telephoned 3 times a day during the first 3 days of the study and then once daily for the remainder of the study to determine if there were any signs of opiate overdose or withdrawal. the patient was to be followed as medically indicated based on the responses to the questions. safety assessments included summarizing the incidences of adverse events (including topical adverse events), vital signs measurements, and clinical laboratory evaluations. blood samples were also collected for analysis of naltrexone and fentanyl concentrations at scheduled times during the study. efficacy assessments included patient global assessments, investigator global assessments, pain intensity, and brief pain inventory. blood samples were also to be collected for analysis of naltrexone and fentanyl prior to any dose change and if a patient experienced a serious adverse event possibly or probably related to study drug. duragesic delivering fentanyl doses of 25 mcg/h, 50 mcg/h, 75 mcg/h, or 100 mcg/h, and a d-trans placebo on days 1, 4, 7, 10, and 13 or d-trans fentanyl with naltrexone delivering fentanyl doses of 25 mcg/h, 50 mcg/h, 75 mcg/h, or 100 mcg/h, and a placebo.

Eligibility criteria:
inclusion criteria: * diagnosis of chronic pain who require continuous opioid analgesia * must enter the study on a stable dose of duragesic for at least 21 days and consent to use a medically acceptable method of contraception throughout the entire study, and for females 1 week after the study is completed and for males 3 months after the study is completed. exclusion criteria: * skin disease that precluded the use of a transdermal system * clinically significant laboratory abnormalities * significant mental status changes that result in disorientation, memory impairment, or inability to report accurately * illicit drug, prescription drug, or alcohol abuse * cardiopulmonary disease * pregnant or breastfeeding.

Keywords: patch fentanyl chronic pain
nexium capsules lda specific clinical experience investigation

Conditions: Gastric Ulcer; Duodenal Ulcer

Summary: the purpose of this investigation is to collect following data in patients given nexium capsule (nexium) for long term in usual-post-marketing therapy to prevention of recurrence of gastric ulcer or duodenal ulcer with low dose aspirin (lda).

nexium capsules specific clinical experience investigation for long-term use concerning prevention of recurrence of gastric ulcer or duodenal ulcer with low dose aspirin (lda).

Eligibility criteria:
exclusion criteria: * patients having gastric ulcer/duodenal ulcer when nexium is started (active phase (a1, a2) or healing phase (h1, h2) of sakita-miwa classification on endoscopy). * patients who had been given nexium for suppression of recurrence of gastric ulcer/duodenal ulcer.

Keywords: low dose aspirin(lda) gastric ulcer or duodenal ulcer nexium
internet-based acceptance based psychotherapy as an adjunct to chronic pain rehabilitation

Conditions: Chronic Pain

Summary: the goal of this clinical trial is to evaluate how an acceptance based internet-delivered psychological treatment (iact) tailored to patients with chronic pain is perceived, and if it meets the needs and expectations of those enrolled. the main question it aims to answer is: what are the expectations of patients with chronic pain prior to iact treatment, and how do they experience iact during and after treatment? participants will be offered a 7 week long treatment with therapist support. they will be interviewed before treatment starts, once during treatment, and again after treatment is completed.

this research project aims to interview adults with chronic pain to explore their expectations before, during, and after receiving internet-based acceptance and commitment therapy (iact). iact aims to increase accessibility to psychological treatment by overcoming geographical, economic, social, or physical barriers. the study will investigate how iact is received and how patient expectations align with their treatment experiences. this is important because previous studies have shown that chronic pain patients' experiences with iact vary greatly, and there is limited knowledge about their specific needs and expectations regarding internet-based psychological treatment. chronic pain is a widespread and challenging condition affecting approximately 20% of the population. internet-delivered psychological treatments, such as iact, have emerged in the past 20 years, showing promising results in managing chronic pain. however, research on patient expectations and experiences with iact remains limited. this qualitative study will use semi-structured interviews to gather data from 10-15 adults with chronic pain. three interviews will be conducted per participant: before, during, and after iact treatment. thematic analysis will be used to analyze the interview transcripts. the iact treatment will consist of 7 modules delivered over 7 weeks. the study's findings will hopefully contribute to a better understanding of how expectations and needs influence the treatment process and outcomes for individuals with chronic pain receiving iact. this knowledge can inform the development and delivery of more effective and patient-centered iact programs.

Eligibility criteria:
inclusion criteria: * participants must be adults with sufficient understanding of swedish to speak and read, have internet access, and currently be a patient at the pain and rehabilitation clinic in linköping. exclusion criteria: * severe cognitive problems, or severe mental illness such as a psychotic episode

Keywords: chronic pain acceptance and commitment therapy internet delivered treatment
newborn screening for adrenoleukodystrophy

Conditions: Adrenoleukodystrophy

Summary: to test if the routine newborn screening dried blood spots can be used to test if elevation of c26:0 lysophosphatidylcholine (c26:0-lyso-pc), a status indicating adrenoleukodystrophy (ald)

parents of newborns will be invited to test if their newborns are affected with ald. the routine newborn screening dried blood spots sample will be used to test the concentration of c26:0-lyso-pc . if positive of a screening test, further confirmation tests including physical examination and other methodology for ald confirmation will be provided. genetic counseling and treatment option will be provided, too.

Eligibility criteria:
inclusion criteria: * babies born in taiwan receive regular newborn screening suggested by ministry of heath and welfare. * parents or legal guardian sign in the informed consent form. exclusion criteria: * parents or legal guardian do not agree to sign in the informed consent form.

Keywords: adrenoleukodystrophy c26:0-lyso-pc
the relationship between zonulin and interleukin-8 levels and postoperative delirium development

Conditions: Postoperative Delirium

Summary: the relationship between zonulin and interleukin-8 levels and postoperative delirium development in patients who had femur fracture surgery under regional anesthesia

patients who are over 65 years of age and scheduled for femur fixation surgery will be included in the study. blood samples for zonulin and interleukin-8 levels will be taken at the day prior to the surgery. all patients will be evaluated by delirium rating scale (drs) for delirium development at the postoperative 1., 2. and 3. days. patients with a drs score over 14 points will be included in the group delirium. and second blood samples for zonulin and interleukin-8 levels will be taken at the time of diagnosis. postoperative pain scores of the patients will recorded by using a numerical rating scale (nrs).

Eligibility criteria:
inclusion criteria: * patients over 65 years with mini mental state score \> 21, undergoing femur fixation surgery exclusion criteria: * anticholinergic drug use, known epilepsy, parkinson, alzheimer's disease, dementia, cognitive function disorder
mobile health platform for surveillance of kidney stone

Conditions: Stone, Kidney

Summary: we plan to investigate whether usage of a mobile health platform for surveillance of stone formers by itself or as an adjunct to standard office-appointments will improve patient compliance and adherence to treatment guidelines and ultimately improve patient care, satisfaction, quality of life, and decrease stone recurrence.


Eligibility criteria:
inclusion criteria: * over 18 years old * urinary tract stone formers * meet the aua guideline indication for metabolic stone evaluation and surveillance * willing to pursue treatment recommendations of a metabolic workup exclusion criteria: * patients without mobile phone capability to utilize getwell loop, * physical or cognitive impairment precluding usage of mobile phone or answering of questionnaires * non-english speaking * inability to consent to the study
study of mechanisms of anovulation in polycystic ovary syndrome

Conditions: Anovulation

Summary: we previously hypothesized that the excess of anti-mullerian hormone (amh) at the level of ovarian selectable follicles could be involved in the follicular arrest of polycystic ovary syndrome (pcos), mainly through inhibition of fsh effect on aromatase expression.in this study, we plan to investigate whether a drop in the serum amh level would be concomitant to the appearance of a dominant follicle induced by administration of mild amounts of exogenous fsh in women with pcos.

women with pcos (rotterdam definition) whom anovulation is resistant to clomiphene citrate will receive recombinant fsh using the low-dose step-up protocol during only one cycle. serum levels of estradiol, amh, lh, fsh, inhibin b and ultrasound (u/s) parameters will be assessed twice a week until 3 days after appearance of \> 1 dominant follicle(s).the starting dose of recfsh will be 50 iu/day. in the absence of criteria for dominance (see below) after 14 days at 50 iu/day, recfsh dose will be increased by 25 iu/day every 7 days until dominance is achieved. dominance will be defined by the appearance of at least one follicle \>10 mm growing at least 2 mm/day and serum e2\> 100 pg/l. ultrsound examination will performed with a 7-mhz transvaginal transducer (sonoline elegra, siemens), in real time, according to a standardized protocol.serum amh levels will be assessed using the second-generation enzyme immunoassay amh-eia.

Eligibility criteria:
inclusion criteria: * normal sperm analysis in the partners and normal hysterosalpingography in all patients * pcos defined by rotterdam criteria * resistance to clomiphene citrate, i.e. no ovulation at 150 mg/day or no pregnancy after 6 ovulatory cycles * informed consent before inclusion exclusion criteria: * on-going pregnancy * age\ 40 yr. * unability to understand the treatment protocol * other medications * any co-existent morbid condition contra-indicating a pregnancy

Keywords: polycystic ovary syndrome follicular arrest anti-mullerian hormone fsh
a study to evaluate adverse events and change in disease activity comparing oral upadacitinib to subcutaneous dupilumab in adolescent and adult participants with moderate to severe atopic dermatitis

Conditions: Atopic Dermatitis

Summary: atopic dermatitis (ad) is a skin condition that may cause a rash and itching due to inflammation of the skin. therapies spread over the skin may not be enough to control the ad in trial participants who require systemic anti-inflammatory treatment. this study compares upadacitinib to dupilumab in adolescent and adult participants with moderate to severe ad who have inadequate response to systemic therapies. adverse events and change in the disease activity will be assessed. upadacitinib and dupilumab are approved drugs for the treatment of moderate to severe atopic dermatitis (ad). the study is comprised of a 35-day screening period, a 16-week treatment period 1 and a 16-week treatment period 2. participants are randomly assigned to 1 of 2 groups called treatment arms to receive upadacitinib dose a or dupilumab in period 1. there is a 30-day or 12-week follow-up visit for those on upadacitinib or dupilumab respectively, who will not enter period 2. in period 2, participants will receive upadacitinib dose a or dose b for 16 weeks, followed by a 30-day follow-up visit. approximately 880 adolescent and adult participants ages 12 to 64 with moderate to severe ad who are candidates for systemic therapy will be enrolled at up to 330 sites worldwide. there may be higher treatment burden for participants in this trial compared to their standard of care . participants will attend regular visits during the study at a hospital or clinic. the effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.


Eligibility criteria:
inclusion criteria: * chronic atopic dermatitis (ad) with onset of symptoms at least 3 years prior to baseline and participant meets hanifin and rajka criteria. * eczema area and severity index (easi) score ≥ 16;validated investigator´s global assessment for ad (viga-ad) score ≥ 3 and ≥ 10% body surface area involvement of atopic dermatitis (bsa of ad) involvement at the baseline visit. * baseline weekly average of daily worst pruritus numerical rating scale (wp-nrs) ≥ 4. * documented history of inadequate response to previous systemic treatment defined as documented history of previous inadequate response to at least one prior systemic treatment for ad or for whom other systemic treatments are otherwise medically inadvisable. exclusion criteria: * history of clinically significant (per investigator's judgment) drug or alcohol abuse within the last 6 months. * history of an organ transplant which requires continued immunosuppression.

Keywords: atopic dermatitis ad level-up upadacitinib dupilumab rinvoq
a safety and efficacy study of shr4640 and febuxostat in subjects with hyperuricemia

Conditions: Hyperuricemia

Summary: the objective of the study is to assess the safety and efficacy of shr4640 and febuxostat in patients with hyperuricemia.


Eligibility criteria:
inclusion criteria: * subject has a body mass index ≥18 and ≤30 kg/m2; * screening sua value ≥8mg/dl; * subject has no clinically relevant abnormalities in vital signs, ecg, physical examination，imaging examination or safety laboratory values. exclusion criteria: * subject known or suspected of being sensitive to the study drugs or its ingredient； * alt、ast、tbil\>1.5uln; * history of kidney stones or screening kidney stones by b-ultrasound； * history of malignancy； * history of xanthinuria； * donated blood（≥400ml）within 3 months prior to screening or received transfusion of blood.
study of silicone material inserts to treat burn scars

Conditions: Burns

Summary: the purpose of this study is to determine if the use of silicone material inserts within pressure garments is effective in decreasing hypertrophic burn scar formation as compared to standard pressure garment therapy.

surgical revision, potential hospitalization, and extensive post-surgical rehabilitation may be required for the revision and correction of hypertrophic burn scars to restore function and prevent disability. this in turn results in an increased financial burden to the medical system. more importantly, the patient is required to undergo an additional invasive medical procedure that can potentially create further hypertrophic scarring. prevention and reduction of hypertrophic scars with non-invasive, cost effective, and evidence based treatment modalities is therefore the most desirable approach. two of the most generally accepted methods of non-invasive treatment, pressure garments and silicone gel sheeting, have been demonstrated to individually treat hypertrophic scarring. recently, burn therapists have begun to use silicone bonded material inserts within pressure garments following the logical deduction that the two therapeutic techniques can be combined to resolve many of the cited individual disadvantages, while reaping the benefits of each individual modality. it is the aim of this study to determine the efficacy of these silicone bonded material inserts within pressure garments in the treatment of hypertrophic scarring.

Eligibility criteria:
inclusion criteria: * patients who would normally receive pressure garments * presence of an acute burn to an upper or lower extremity that requires treatment with a sheet or meshed graft * minimum 4% total body surface area graft dimension (this must include areas above and below the elbow or on medial and lateral aspects of the calf * between 16 years and 60 years of age * patient must consent to the study or obtain consent from guardian if \<18 years of age * must be available for follow-up at 1 month, 3 months, 6 months, and 12 months post initiation of treatment exclusion criteria: * presence of pre-existing hypertrophic or keloid scarring * pressure garments initiated greater than 2 months post discharge from hospital * pre-existing decrease in range of motion of affected extremity * one treatment area with a prolonged healing phase or which had been treated differently in comparison to adjacent treatment area * patient unable to comprehend or participate in self reporting

Keywords: hypertrophic scarring silicone material pressure garments
effect of roflumilast on pulmonary function and respiratory symptoms in patients with chronic obstructive pulmonary disease (copd) (by217/m2-110)

Conditions: Chronic Obstructive Pulmonary Disease; COPD

Summary: the aim of the study is to compare the effect of roflumilast and placebo on the lung function in patients with copd.


Eligibility criteria:
main inclusion criteria: * clinical diagnosis of copd (chronic obstructive pulmonary disease) * currently stable copd with no change in copd treatment in the prior 4 weeks main exclusion criteria: * clinical diagnosis of asthma * poorly controlled copd * regular need for daily oxygen therapy

Keywords: roflumilast chronic obstructive pulmonary disease copd
a study to evaluate efficacy and safety of hs-10374 for mild-to-moderate plaque psoriasis

Conditions: Psoriasis

Summary: this study has been designed to explore the clinical efficacy and safety of hs-10374 in the treatment of mild-to-moderate plaque psoriasis.

this is a 12-week, multi-center, randomized, double-blind, placebo-controlled, phase ii study. the study duration includes a 4-week screening period, a 12-week placebo-controlled treatment period, and a 4-week follow-up period. all eligible subjects will be randomly assigned in a 2:2:1 ratio to receive hs-10374 dose 1, hs-10374 dose 2, or placebo.

Eligibility criteria:
inclusion criteria: 1. male or female subjects between the ages of 18-70 years 2. diagnosis of plaque psoriasis for at least 6 months 3. spga score of 2-3, bsa 2-15%, pasi score 2-15 4. subject must be inadequately controlled with, or intolerant of at least one topical therapy exclusion criteria: 1. diagnosis of non-plaque psoriasis or drug-induced psoriasis 2. recent history of infection, history or risk of serious infection 3. any major illness or evidence of unstable condition of major organ systems including psychiatric disease 4. any condition possibly affecting the pk process of the study drug 5. evidence of other skin conditions that would interfere with the evaluation of psoriasis 6. history of hypersensitivity to the ingredients of study drugs, history of anaphylaxis 7. prior exposure to tyk2 inhibitors 8. have received the prohibited treatment during the protocol required washout period 9. any significant laboratory or procedure abnormalities that might place the subject at unacceptable risk during this study period