Kornimate/medical-research-clean huggingface dataset:
a trial monitoring therapy pathways of asthma patients treated with an extrafine ics/laba/lama single-inhaler triple therapy in a real-world setting and characterizing the effects on health-related out-comes

Conditions: Asthma

Summary: trimaximize, a non-interventional trial aims to collect prospective, longitudinal data from asthma patients under routine care, for whom their treating physician has decided to prescribe trimbow® (beclometasone/formoterol/glycopyrronium).

trimaximize, a non-interventional trial aims to collect prospective, longitudinal data from asthma patients under routine care, for whom their treating physician has decided to prescribe trimbow® (beclometasone/formoterol/glycopyrronium). trimbow is a fixed triple therapy containing a long-acting muscarinic antagonist (lama, glycopyrronium), a long-acting beta-adrenergic agonist (laba, formoterol) and an inhaled corticosteroid (ics, beclometasone). asthma patients often need to use multiple inhalers as part of their therapy, which require different inhalation techniques. it has been shown that the use of several inhalers of different mode of action, design and dosage requirements may have a detrimental effect on patient adherence and subsequent treatment outcomes. in this prospective, non-interventional trial, the investigators aim to evaluate aspects of adherence to trimbow, a single-inhaler triple therapy (sitt) as a maintenance treatment of asthma, to gather knowledge from routine care on whether appropriate step-up to sitt leads to greater adherence and better health outcomes.

Eligibility criteria:
inclusion criteria: 1. patients ≥ 18 years of age, 2. patients with confirmed leading diagnosis of asthma with or without concomitant copd, 3. physician decision to start fixed triple therapy with ics/laba/lama (trimbow ms or hs) according to its current authorised indication. the treatment decision must be made independently from participation in this nis, 4. patients willing and able to sign an informed consent for use of their pseudonymised clinical data within the present non-interventional study. exclusion criteria: 1) participation in an interventional clinical trial within 30 days prior to enrolment into the present non-interventional study or planned enrolment in an interventional clinical trial during the observational period.

Keywords: trimbow asthma triple therapy beclometasone formoterol glycopyrronium trimaximize
the effect of telehealth applications on the level of anxiety in the treatment of infertility

Conditions: Infertility

Summary: it is expected that 84% natural pregnancy will occur at the end of the first 12 months of sexual intercourse without the use of contraceptive methods.the lack of natural fertility is under the influence of multiple factors. these factors can be summarized as age, past infections, genetic factors, anatomical structural disorders, environmental toxins, occupational exposure, lifestyle and sexually transmitted infections.severe psychological stress, anxiety and depression are encountered in the diagnosis, treatment method and management of the related process in couples who are faced with the diagnosis of infertility. with the telehealth service that came to the fore in the world in the 1950s, nurses use it in the management of many treatment processes such as infertility treatment, with the roles of managing the information collection process, making decisions with the information they receive, and transmitting information on patients who are far away and need constant follow-up. assisted reproductive technologies, which are the current treatment method of infertility, have been used effectively for thirty years. anxiety control is important in the success of treatment in the treatment process, which is both costly and stressful. providing 24/7 hours of counseling by using telehealth methods contributes to the reduction of this anxiety.

ethics committee and hospital approval were obtained in order to conduct the study. the sample of the study consists of people who applied to the ivf clinic of süleyman demirel university research and practice hospital. the work is planned to be completed between april 2021 and march 2022. in the first meeting with the participants, it is carried out by taking precautions to protect against the covid 19 pandemic, in cases where it is met face to face. participants will be divided into groups with 1 to 1 method in randomization. participants assigned to the intervention group will be given a personal information form and beck anxiety scale before treatment, followed by telehealth service throughout the treatment protocol, and the beck anxiety scale will be repeated at the end of the treatment. in the control group, a personal information form and beck anxiety scale will be applied before the treatment and will be repeated after the procedure.

Eligibility criteria:
inclusion criteria: * between the ages 20-45 * female * having been diagnosed with infertility * should be able to use a smart phone * open to communication exclusion criteria: * not between the ages of 20-45 * individuals who do not want to be inherited

Keywords: infertility telehealth anxiety consultancy
deep transcranial magnetic stimulation for treatment of alzheimer's disease

Conditions: Alzheimer's Disease

Summary: the primary objective of this trial is to assess the ability of transcranial magnetic stimulation with h coil to prefrontal cortex , with an addition of cognitive brain training, to improve cognitive performance in patients with alzheimer's disease which received drug treatment. this study is a single-center, double-blind 4 months duration trial.

primary outcome measure: adas-cog (time frame baseline, 2 months, 4 months) secondary outcome measure: cgi-c,fab, adl, neuropsychological computerized test(time frame baseline, 2 months, 4 months. estimated enrollment: 40 patients estimated study start date: november 2008 estimated study completion date: november 2009 number of arms: 2 ages: 50-85 genders: both

Eligibility criteria:
inclusion criteria: 1. men and women aged 50-85. 2. diagnosed with alzheimer's disease for at least one year (by the dsm-iv criteria). 3. scored below 24 on the mmse. 4. received drug therapy for their disease, with each treatment having been administered at an acceptable dosage for at least 5 weeks, with either no effect or only partial response. 5. answered in the negative to all questions in the pre-tms treatment safety questionnaire. 6. gave their oral and written consent to participate in the trial. exclusion criteria: 1. an additional neurological or psychiatric disorder. 2. severe personality disorder. 3. uncontrolled hypertension. 4. history of epilepsy, seizure, or heat convulsion. 5. history of epilepsy or seizure in first degree relatives. 6. history of head injury or stroke. 7. history of metal implants in the head (except dental fillings). 8. history of surgery entailing metallic implants or known history of any metallic particles in the eye, implanted cardiac pacemaker, cochlear implants, use of neurostimulators, or any medical pumps. 9. history of migraines in the last six months. 10. history of drug or alcohol abuse. 11. inadequate communication with examiner. 12. participation in another clinical study, either concurrent with this trial or in the 3 months preceding it. 13. inability to sign a consent form.
a trial investigating the efficacy and safety of insulin degludec in children and adolescents with type 1 diabetes mellitus

Conditions: Diabetes; Diabetes Mellitus, Type 1

Summary: this trial is conducted in africa, asia, europe and the united states of america (usa). the aim of this trial is to investigate the efficacy and safety of insulin degludec in children and adolescents with type 1 diabetes mellitus.


Eligibility criteria:
inclusion criteria: * informed consent, and child assent as age-appropriate, obtained before any trial-related activities (trial-related activities are any procedure that would not have been performed during normal management of the subject). the parents or legal representative of the child must sign and date the informed consent form according to local requirements. the child, if possible, parents or legal representative of the child must sign and date the child assent form according to local requirements * male or female diagnosed with type 1 diabetes mellitus (t1dm) (based on clinical judgement and supported by laboratory analysis as per local guidelines) * ongoing daily treatment with insulin (any regimen) for at least 3 months prior to visit 1 (screening). no oads (oral anti-diabetic drugs) are allowed * hba1c (glycosylated haemoglobin) maximum 11% exclusion criteria: * known or suspected hypersensitivity to trial product(s) or related products * previous participation in this trial. participation is defined as randomisation * girls who are pregnant, breastfeeding or intend to become pregnant * girls who have had menarche and are not using adequate contraceptive measures according to local requirements * known hypoglycaemic unawareness or recurrent severe hypoglycaemic events as judged by the investigator (trial physician) * more than 1 diabetic ketoacidosis requiring hospitalisation within the last 3 months prior to visit 1 * significant concomitant disease, except for conditions associated with type 1 diabetes mellitus, which in the investigator's opinion could interfere with the trial * the receipt of any investigational drug within 1 month prior to visit 1
the impact of group singing on patients with stroke and their personal caregivers

Conditions: Stroke and Aphasia

Summary: the study will focus on the impact of communal singing on patients with stroke and their personal caregivers. forty post-stroke patients will be randomly assigned to two groups: the first group of 20 stroke survivors and their caregivers (up to 40 total participants) will receive 6 months (approximately 24 sessions) of music therapy. the second control groups of 20 stroke survivors and their caregivers will receive standard post-stroke care

the study will focus on the impact of communal singing on patients with stroke and their personal caregivers. forty post-stroke patients will be randomly assigned to two groups: the first group of 20 stroke survivors and their caregivers (up to 40 total participants) will receive 6 months (approximately 24 sessions) of music therapy. the second control groups of 20 stroke survivors and their caregivers will receive standard post-stroke care. all enrolled participants will be assessed on their mood, past music experience and music genre preference (music therapy assessment). they will complete the abridged beck (bdi-2-fastscreen) questionnaire, the stoke and aphasia quality of life scale; a likert which measures distress; the western aphasia battery (wab); the nih stroke scale (ss); the figely compassion scale; and the driving scene test (stern and white); and the rankin. in additional we will take saliva samples from all participants to measure hormone levels. participants can attend zoom or live.

Eligibility criteria:
inclusion criteria: * stroke victim, regardless of level of stroke exclusion criteria: * none
exercise for oncology care professionals

Conditions: Burnout, Caregiver; Compassion Fatigue

Summary: the goal of this preference-based pilot study will be to assess the feasibility and acceptability, and impact of a 12-week exercise intervention on oncology care provider burnout. participants self-select to participate into one of two exercise groups. group assignment will be based on participant preference. group 1: supervised circuit-based resistance exercise group 2: nature-based walking


Eligibility criteria:
inclusion criteria: * 18 years of age or older; * able to speak/write in english; * must be providing formal care to cancer patients in a clinical setting within the halifax municipality; * actively practicing within the nova scotia cancer care program; and * able and willing to engage in low-to-moderate intensity physical activity. exclusion criteria: * exceeding canadian physical activity guidelines of 150-minutes of moderate-to-vigorous physical activity per week; and * any health condition that would preclude safe participation in a new exercise program.

Keywords: oncology health professionals burnout exercise physical activity nature-based walking
honduras liger thermocoagulator study

Conditions: Cervix Cancer; Cervix Lesion

Summary: this was a prospective study to evaluate the short-term safety and acceptability of the liger medical thermal coagulation device for treatment of cervical precancerous lesions. study results will inform the honduras ministry of health regarding potential use of the liger device for precancer treatment in honduras and results may be of interest to other latin american settings as well. the research was conducted in the tegucigalpa region in honduras in 4 health facilities in urban and peri-urban settings. participants were women ages 30-49 who met the study eligibility criteria. human papilloma virus (hpv) and visual inspection with acetic acid (via)-positive women who were eligible for ablative treatment were offered thermal coagulation with the liger instrument to treat their lesions and asked about acceptability of the treatment. at this visit, biopsies were also be taken. women were followed-up at 1 month to evaluate short-term safety outcomes with a physical exam and receive their biopsy results. depending on their biopsy results, they will be asked to return for repeat screening, referred for further treatment or asked to come back for a 12-month study visit. at the 12-month visit after treatment, women were followed up to evaluate cure rates. a second investigational device, pocket colposcope, was used to take cervix photos at the enrollment and 12-month study visit with participant consent. the photos were used to explore factors influencing treatment failure. de-identified photos and women's diagnosis information were also shared with the device developers, duke university, for the purposes of improving their device. women had the option to opt out of having cervix photos taken and still participate in the treatment portion of the study.


Eligibility criteria:
inclusion criteria: women * aged 30 to 49 years. * hpv and via positive. * eligible for ablative treatment using world health organization guidelines \[29\]. * the lesion covers \<75% of the cervix, the lesion does not enter the endocervical canal, the entire lesion can be visualized and covered by the liger medical thermocoagulator probe, and there is no suspicion for invasive cancer. exclusion criteria: * are pregnant or less than 3 months post-partum * are not hpv and via positive * do not have a cervical lesion that qualifies for ablative treatment * have a bleeding disorder or taking anti-coagulant medication. * do not give informed consent; or unable to provide the consent.

Keywords: thermocoagulation treatment cervical precancer
a study comparing trifarotene cream 0.005% to aklief® cream in the treatment of acne vulgaris

Conditions: Acne Vulgaris

Summary: to demonstrate therapeutic equivalence and safety of trifarotene cream 0.005% (taro pharmaceuticals u.s.a., inc.) and aklief® cream in the treatment of acne vulgaris

a multi-center, double-blind, randomized, placebo-controlled, parallel-group study, comparing trifarotene cream 0.005% (taro pharmaceuticals u.s.a., inc.) to aklief® cream and both active treatments to a placebo control in the treatment of acne vulgaris

Eligibility criteria:
inclusion criteria: * healthy male or non-pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris. * subjects who are 18 years of age or older (up to the age of 40) must have provided irb approved written informed consent. subjects ages 12 to 17 years of age inclusive must have provided irb approved written assent; * subjects must have a definite clinical diagnosis of acne vulgaris of severity grade 2, 3,or 4 as per the investigator's global assessment (iga) * subjects must have ≥ 25 non-inflammatory lesions (i.e., open and closed comedones) and ≥ 20 inflammatory lesions (i.e., papules and pustules) and ≤2 nodulocystic lesions (i.e., nodules and cysts), at baseline on the face. exclusion criteria: * female subjects who are pregnant, nursing or planning to become pregnant during study participation * subjects with a history of hypersensitivity or allergy to tretinoin, retinoids, or any of the study medication ingredients. * subjects with the presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris (e.g., on the face: rosacea, dermatitis, psoriasis,squamous cell carcinoma, eczema, acneiform eruptions caused by medications,steroid acne, steroid folliculitis, or bacterial folliculitis).
functional near-infrared spectroscopy for anxiety monitoring and neurofeedback.

Conditions: Anxiety Disorders

Summary: the objective of this subproject is to validate the efficacy of the fnirs real-time anxiety monitoring and neurofeedback system. in the first year, the cerebral hemodynamics measured by commercial fnirs during resting state and cognitive tasks from 60 generalized anxiety disorder (gad) patients and 30 healthy subjects will be processed and analyzed using ai algorithms. the novel anxiety fnirs biomarker will be identified and correlated to clinical anxiety scales (such as hars and stai). in the second year, the validity and responsiveness of the ai-fnirs biomarker will be validated. the accuracy of using ai-fnirs biomarker to predict the diagnosis of gad (according to dsm-5) and anxiety rating scales will be calculated from 60 gad patients and 30 healthy subjects. in the third year, a neurofeedback method using ai-fnirs biomarkers to guide digital cognitive behavior therapy (dcbt) through visual/audio cues will be developed. a pilot study with 12 gad patients will be performed to test the feasibility of mindfulness training during ai-fnirs neurofeedback. in the fourth year, a large scale rct will be performed to validate the therapeutic efficacy of ai-fnirs neurofeedback dcbt in 40 patients with gad. the protocol of using real-time ai-fnirs biomarkers as a neurofeedback to augment mindfulness training will be optimized according to previous year.


Eligibility criteria:
inclusion criteria: * being diagnosed with generalized anxiety disorder (gad) by psychiatrists based on dsm-v. * native chinese speakers. * right-handers. * normal vision without or after correction. * normal hearing and verbal expression. * regular returns of medical or psychological intervention during participation. exclusion criteria: * being diagnosed with other major neurological or mental disorders.
addition of prednisolone and heparin in patients undergoing ivf with failed ivf cycles

Conditions: Infertility

Summary: the addition of heparin and prednisolone increases pregnancy outcome parameters in women undergoing in vitro fertilisation (ivf) with failed ivf cycles.


Eligibility criteria:
inclusion criteria: * personal history of ≥2 failed ivf/icsi cycles * age \<45 years * availability of fresh ejaculate sperm for ivf/icsi procedures * confirmation of normal uterine cavity * presence of good quality (grade i or ii) embryos for transfer exclusion criteria: * endocrine disorders * immune disorders * coagulation disorders

Keywords: low molecular weight heparin prednisolone glucocorticoids recurrent implantation failure pregnancy rate
respiratory rehabilitation exercises in older adults with acute exacerbations of chronic obstructive pulmonary disease

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: the purpose of this randomized controlled trial was to evaluate the effects of a respiratory rehabilitation exercise training package on dyspnea, cough, exercise tolerance, and sputum expectoration of hospitalized elderly patients with acute exacerbation of chronic obstructive pulmonary disease (aecopd). using purposive sampling, 61 participants were recruited and randomly assigned to either the experimental group (n = 30) or the control group (n = 31). the experimental group participants received the respiratory rehabilitation exercise training twice a day and 10-30 minutes per session for four days. the control group participants received usual care and health education. data were collected at baseline and at the end of the four-day intervention.

the respiratory rehabilitation exercise training package included: (a) disease awareness: the doctor explained the disease to patients and their families through the chest x-ray, (b) sputum clearance treatments: easily understood postural drainage cards were provided to the patients and families to assist with proper sputum clearance procedures, (c) pursed lip breathing training: devices were provided to the patients to ensure that the breathing exercises were completed properly, (d) upper-limb exercise with breathing pranayama: towels were provided to the patients to assist with upper-limb exercises properly, (e) walking training with breathing pranayama: legs were elevated while inhaling, and returned to the position while exhaling, and (f) assign a pulmonary rehabilitation program coordinator: coordinators were assigned to assist the patients in nutrition management and health education.

Eligibility criteria:
inclusion criteria: 1. diagnosed with moderate copd with moderate acute exacerbation 2. over 65 years of age 3. conscious clear 4. with shortness of breath or dyspnea that was not caused by heart disease, pneumothorax, or pulmonary edema 5. had received bronchodilator aerosol therapy or antibiotic treatment, but had not been treated with an antitussive exclusion criteria: 1. unstable vital signs 2. blood oxygen concentration lower than 90% 3. unstable psychological status, hemoptysis, pneumothorax, pulmonary edema, or using the respirator

Keywords: acute exacerbation of chronic obstructive pulmonary disease older adults respiratory rehabilitation exercise
study to assess the safety and tolerability of idebenone in the treatment of friedreich's ataxia patients

Conditions: Friedreich's Ataxia

Summary: this study is meant to assess the safety and tolerability of idebenone in patients with friedreich's ataxia over a 12 months period.

the study involves 6 clinic visits.

Eligibility criteria:
inclusion criteria: * friedreich's ataxia patients completing core study snt-iii-002 (nct00537680) and presenting at week 24 (visit 5) of that study * body weight ≥ 25kg/55 lbs * negative urine pregnancy test * patients who in the opinion of the investigator are able to comply with the requirements of this study exclusion criteria: * adverse events during the course of snt-iii-002(nct00537680)which in the opinion of the investigator are attributable to idebenone and preclude further treatment with idebenone * clinically significant abnormalities of clinical hematology or biochemistry including, but not limited to, elevations greater than 2 times the upper limit of normal of ast, alt or creatinine * treatment with coenzyme q10, vitamin e (if taken at a dose 5 times above the daily requirement) or other sources of idebenone within the past month * parallel participation in another clinical drug trial * past or present history of abuse of drugs or alcohol * pregnancy or breast-feeding

Keywords: friedreich's ataxia idebenone icars