Kornimate/medical-research-clean huggingface dataset:
fertiscreen: an online application to improve the quality of fertility care

Conditions: Unexplained Subfertile Couples With a Good Prognosis.

Summary: objectives the investigators present an online application to empower and inform patients and improve guideline adherence in unexplained subfertility. thereby the investigators expect to reduce overtreatment in fertility care with higher quality of care. methods the investigators conduct a prospective cohort study including couples with a diagnosis of unexplained subfertility. couples consulting their general practitioner with an unfulfilled child wish will be offered to use fertiscreen. fertiscreen is an online application, in which patients are asked questions about their fertility problem (ie menstrual cycle, age, duration of child wish and the results of the chlamydia trachomatis antibody titre and semen analysis). fertiscreen then uses the validated prediction model of hunault to calculate couples' chance of natural conception during the next twelve months. in addition, patients can find links to extra information concerning subfertility. couples can then initiate an online consultation with their general practitioner and a gynaecologist, in order to discuss their results and prognosis. when the calculated prognosis of spontaneous conception within one year is \>30%, tailored expectant management for 6-12 months will be advised, as no benefit can be expected from fertility treatment. questionnaires will be sent to patients as well as to their caregivers (general practitioner, gynaecologist). these questionnaires will focus on the use of fertiscreen (system usability scale) and the different domains of quality of care (effectiveness, cost-effectiveness, safety, patient-centredness). for the latter, the investigators use the hospital anxiety and depression scale and the patient centredness questionnaire for infertility. in order to be able to draw conclusions, the investigators will conduct a baseline measurement among couples with unexplained subfertility who have been referred to a fertility clinic. their data will be abstracted from their medical records and they will receive the aforementioned questionnaires as well (except for the system usability scale). the investigators will recruit couples presenting to general practitioners in the nijmegen area (which for second line treatment consists of one general hospital and one academic hospital). to detect an increase in guideline adherence of the current 60% to 75% with a power of 80% (p\<0,05), the investigators need to include 152 couples in the before as well as in the after measurement.


Eligibility criteria:
inclusion criteria: * couple consulting their general practitioner with subfertility * women \>18 years and \<38 years * one of the partners dutch speaking * access to the internet * residing in the netherlands * unfulfilled childwish for at least 6 months

Keywords: e-health intervention infertility primary care referral rate
the effects of psilocybin on shared experience in film processing

Conditions: Disorders of Consciousness; Psychedelic Experiences

Summary: the goal of this clinical trial is to learn whether certain methods of detecting awareness in vegetative or minimally conscious patients (using neuroimaging) are sensitive to the effects of psilocybin (a psychedelic drug). one of these methods includes scanning peoples\&#39; brains while they watch a film. when different individuals watch a film, their brains become synchronized with each other as they watch the plot unfold. most importantly, if a seemingly unconscious patient also shows the same brain-synchronization, it means they might actually be conscious and aware. to approach this goal, the investigators will be carrying out this trial in healthy volunteers. this will help better understand whether psilocybin may be a potential treatment for restoring awareness in these patients. the main questions it aims to answer are: * does psilocybin enhance or diminish brain synchrony during a film? * do changes in brain synchrony reflect differences in each individual\&#39;s conscious experience? participants will be asked to: * attend two brain scanning sessions and watch a series of film clips, perform a brief mental imagery task, and listen to music - once under a placebo, and once under psilocybin. * play a series of games that assess their cognition (memory, reasoning, planning, etc.). * perform a series of visual illusions tasks.


Eligibility criteria:
inclusion criteria: participants must: * have access to an internet connection * be in good general health * be 19 years of age, or older * be willing to follow the study protocol exclusion criteria: the following people will be excluded from the study. those who: * are unable to read english * have high blood pressure * are pregnant (determined by a urine pregnancy test at in-person screening) * are not using effective methods of contraception with their partner(s) (e.g. oral contraceptive pill, injection, implant, patch, vaginal ring, intrauterine coil, intrauterine device, tubal ligation, or barrier method) * are taking chronic administration of tricyclic antidepressants and/or lithium * are taking acute administration of serotonin reuptake inhibitors * are currently using the antipsychotic medication haloperidol * are currently using monoamine oxidase inhibitors * have any current or past history of meeting the diagnostic and statistical manual of mental illnesses (dsm-v) criteria for schizophrenia, bipolar i, bipolar ii, or psychotic symptoms * have any first or second-degree relatives with history of above disorders/symptoms * have any other diagnosed and/or extreme psychiatric disorders, such as anxiety, depression, post-traumatic stress disorder (ptsd), addiction, obsessive-compulsive disorder (ocd), etc. * have any history of suicidal behaviour or current/recent suicidal ideation (determined by the columbia-suicide severity rating scale \[c-ssrs\] at in-person screening)

Keywords: psilocybin functional magnetic resonance imaging (fmri) cognition disorders of consciousness film processing healthy volunteers
improving outcome of very preterm infants using collaborative quality improvement

Conditions: Morbidity;Newborn; Morality

Summary: a multicenter interventional study using evidence-based collaborative quality improvement to reduce mortality and major morbidities of very preterm infants in six neonatal centers in shanghai

a multicenter interventional study using evidence-based collaborative quality improvement to reduce mortality and major morbidities of very preterm infants using evidence-based collaborative quality improvement interventions including benchmarking, potential better practice list, pdsa implementation and collaborative learning.

Eligibility criteria:
inclusion criteria: 1. infants born at \>=24+0 weeks' gestation and \<32+0 weeks' gestation; 2. admitted to the participating nicus within 7 days after birth during study period exclusion criteria: 1. infants with major congenital anomalies; 2. infants who transferred to non-participating hospitals within 24 hours after birth;

Keywords: very preterm infant quality improvement mortality morbidities
effects of progressive muscle relaxation training with music therapy on sleep quality and trait anger/anger expression style of patients at community mental health center

Conditions: Sleep; Anger; Psychiatric Disorder

Summary: aim: the aim of the study was to examine the effects of progressive muscle relaxation training with music therapy on sleep quality, trait anger, and anger expression style of patients at the community mental health center. method: the study is conducted as the pretest-posttest control group design. the study population consisted of chronic psychiatric patients who continue in a community mental health center located in southeastern turkey. the days when the participants came to the community mental health center were selected and the participants divided into two groups as an intervention and control group.


Eligibility criteria:
inclusion criteria: * having a chronic psychiatric diagnosis according to dsm-v diagnostic criteria, * open and cooperate for communication, * living in the city center, * age was between 18-60 exclusion criteria: * patients who have just started the community mental health center * patients diagnosed with axis 1, * patients diagnosed with mental retardation, * patients with drug or alcohol addiction, * patients diagnosed with organic brain syndrome,

Keywords: sleep quality anger psychiatric disorder therapy
ovarian reserve in premenopausal breast cancer

Conditions: Premenopausal Breast Cancer; Breast Cancer

Summary: this is a translational, mutlicentre study. the aim of this study is to determine whether pre-treatment levels of hormones predict ovarian follicular reserve post adjuvant or neoadjuvant chemotherapy for breast cancer and chemotherapy induced amenorrhea.

it is proposed that levels of amh and inhibin a and b measured will give an indication of the residual ovarian reserve in women with breast cancer treated with chemotherapy. in addition, amh might give an indication of the possible efficacy of gnrh agonists in fertility preservation and the effect on ovarian follicular reserve using different adjuvant chemotherapy regimens. those likely to be offered gnrh agonists are younger women with no children and a wish to have some in the future. older women who have completed their families are less likely to be offered a gnrh agonist.

Eligibility criteria:
inclusion criteria: 1. documented histological diagnosis of invasive breast cancer 2. patient due to be treated with chemotherapy (neoadjuvant or adjuvant)\* 3. female patients aged between 18 and 50 years 4. premenopausal status as defined by a hormone profile within the pre-menopausal range as defined by local lab or the patient's last menstrual period had to be within the last 180 days or an iud is used for contraception. 5. ability to provide written informed consent * patients treated with gnrh agonist or adjuvant herceptin or participating in other clinical trials are also eligible exclusion criteria: 1. patients with hypothalamic/pituitary disorder 2. history of ovarian tumour 3. current pregnancy
continuing lamivudine versus switching to entecavir in patients who achieved undetectable hbv dna

Conditions: Hepatitis B, Chronic

Summary: this is a randomized, open-labelled, prospective 96-week study comparing the antiviral efficacy and safety of switching to entecavir 0.5mg qd from lamivudine versus maintaining lamivudine 100mg qd treatment in chb patients currently receiving lamivudine monotherapy.

entecavir has a higher potent antiviral efficacy and a lower drug resistance rate than those of lamivudine in nucleoside-naïve chb patients. the switch from lamivudine to entecavir in patients who have undetectable hepatitis b virus dna (hbv dna \< 60 iu/ml) may lead to more prolonged viral suppression to undetectable level by pcr method, compared to patients with continuous lamivudine treatment. the results of this study will provide a rationale for switch treatment from one antiviral to another one, especially from lam to etv.

Eligibility criteria:
inclusion criteria: * adult subjects (18-70 years of age) currently taking lamivudine monotherapy for chronic hbv infection for at least 6 months with \< hbv dna 60 iu/ml level and hbeag positive status. exclusion criteria: * subjects treated with other antiviral drugs (e.g. adefovir) in combination with lamivudine are not eligible for this study. * subjects should have alt \< 10 x uln, and no evidence of hepatocellular carcinoma. * subjects should be without serological evidence of co-infection with hcv, hiv, or hdv. * subjects with decompensated liver disease, as well as pregnant or breast-feeding women, will not be eligible for the study.

Keywords: chronic hepatitis b lamivudine entecavir
prospective, multi-center adult spinal deformity outcomes database registry

Conditions: Spinal Deformity

Summary: the clinical, radiographic, and hrql outcomes will be compared in operative and nonoperative adult spinal deformity patients.


Eligibility criteria:
inclusion criteria: * diagnosis of adult degenerative or idiopathic scoliosis with a curvature of the spine measuring greater than or equal to 20 degrees * sagittal vertical axis (sva) \> 5cm * pelvic tilt \> 25 degrees * thoracic kyphosis \> 60 degrees * age 18 or greater at the time of enrollment. exclusion criteria: * diagnosis of scoliosis other than degenerative or idiopathic (i.e. paralytic/neuromuscular, congenital) * age \<18 yrs at time of surgery or initial consultation

Keywords: scoliosis kyphosis treatment outcomes spinal deformity
microsurgical vs macro surgical approach for grade ii gingival recessions employing laterally repositioned flap

Conditions: Gingival Recession, Localized

Summary: this study was conducted to assess the evaluation of micro and macro surgical approach in the treatment of grade ii gingival recessions using the laterally repositioned flap

in this study total, 30 patients were selected the patients initially received a comprehensive periodontal examination and complete plaque control program including oral hygiene to eliminate habits related to the aetiology of recession. scaling, root planning and occlusal adjustments were done the patients were randomly assigned and divided into two groups. group a and group b. patients with miller class ii were treated with a laterally repositioned flap to obtain root coverage using conventional macrosurgical approach (15patients) and microsurgical approach(15patients) the clinical parameters evaluated were height of gingival recession relative clinical attachment level which was measured as the distance from a fixed point in a stent to the bottom of the pocket and gingival biotype at baseline, 3 months and 6 months period

Eligibility criteria:
inclusion criteria: * age 20-50 yrs * classii gingival recession * vital teeth that were free from caries or inadequate restorations * sufficient width of attached gingiva exclusion criteria: * any systemic diseases and smokers * classi,iii\&iv gingival recession * abnormal frenal attachments * interdental bone loss with tooth mobility
effect of cacicol20 on corneal epithelial healing after cross-linking in patients with keratoconus

Conditions: Keratoconus

Summary: cacicol20 is an ophthalmic solution based on the technology of rgtas (regeneratingagents). it consists of large biopolymers, imitating the structure of heparansulphate. the protecting effect on different biological tissues and enhancement of wound healing has been described in several studies. keratoconus is a relatively common disease, with incidences ranging from 1.3 to 25 per 100,000 per year across different populations. corneal collagen cross-linking represents a treatment option for these patients, aiming to prevent progression of the disease via stabilization of corneal microstructure. corneal epithelial removal prior to the ultraviolet a/riboflavin cross-linking procedure significantly improves the outcome of the intervention, due to ameliorated distribution of riboflavin. the aim of the present study is to investigate the effect of cacicol20 on corneal epithelial wound closure after collagen cross-linking in patients with keratoconus. results may lead to an improved management and pain reduction of patients with corneal epithelial defects.


Eligibility criteria:
inclusion criteria: * men and women aged over 18 years * presence of keratoconus * scheduled for corneal cross linking * no ophthalmic surgery in the 3 months preceding the study exclusion criteria: * participation in a clinical trial in the previous 3 weeks * topical use of aminoglycosid antibiotics * use of therapeutic or refractive contact lenses after surgery * known hypersensitivity to any component of the study medication or heparinoids or heparin * active ocular infection * presence of any abnormalities preventing reliable measurements as judged by the investigator * pregnancy, planned pregnancy or lactating

Keywords: cross-linking rgta otr4120 (cacicol20)
psychological prevention of internalizing disorders

Conditions: Anxiety Symptoms; Depressive Symptoms; Somatoform Symptoms

Summary: the purpose of this study is to determine whether cognitive-behavioral group prevention (cbt-g) for german children is effective and to what extent parental group training moderates outcome.

internalizing disorders represent a large group of psychological disorders among children who are referred to psychological treatment. anxiety, depression and somatoform disorders in children and adolescents increase the risk of mental disorders in adulthood. some english programs have proved the efficacy of cbt-g prevention.this study will test the efficacy of cbt-g in german children. the role of parental involvement is currently subject to scientific discussions. the impact of an additional parent-group training will be investigated.

Eligibility criteria:
inclusion criteria: * age 8- 12 years and * anxiety symptoms and/or * depressive symptoms and/or * somatoform symptoms exclusion criteria: * psychiatric disorder according to icd-10/ dsm-iv-tr requiring individual psychotherapy * iq \< 85
provision of breakfast food in behavioral weight loss

Conditions: Obesity

Summary: a contributing factor to the rising prevalence of obesity may be increased portion sizes. however, the effect of portion size has not been studied independent of the effect of quantity of food in the context of a behavioral weight loss program. providing pre-portioned single servings of food may make it easier to reduce caloric and dietary fat intake improving weight loss. in addition, breakfast skipping is associated with obesity and breakfast consumption is associated with weight loss success. therefore, the objective of the proposed study is to investigate the effect of portion size on consumption of provided breakfast foods in the context of a behavioral weight loss program. participants will be randomized to 1 of 2 standard 12-week behavioral obesity interventions. the first intervention, serving as a control, will provide participants with breakfast foods in non-portioned containers (standard). a second intervention will provide participants with the same type and quantity of breakfast foods but they will be provided in pre-portioned single servings (portion). dependent variables include the number of calories consumed from the provided foods as well as overall caloric and fat consumption. if the provision of food in pre-portioned servings is effective at decreasing intake, future directions include conducting longer interventions to improve long-term weight loss outcomes in standard behavioral interventions.


Eligibility criteria:
inclusion criteria: 1. age between 21 and 65 years. older adults may have more medical co-morbidities and may require greater medical supervision. 2. body mass index (bmi) between 25 and 40 kg/m2. based upon the evidence report (national heart, lung, and blood institute \[nhlbi\], 1998), weight loss is recommended for individuals with a bmi \> 25. however, individuals with a bmi of \> 40 have more medical co-morbidities and require greater medical supervision. 3. average current consumption of breakfast on four days or fewer. exclusion criteria: 1. report allergies to any of the foods provided in the treatment or report lactose intolerance due to the high lactose content of some of the foods provided. 2. report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the physical activity readiness questionnaire (par-q) (thomas, reading, \& shephard, 1992). individuals endorsing joint problems, prescription medication usage, or other medical conditions that could limit exercise will be required to obtain written physician consent to participate. 3. report major psychiatric diseases or organic brain syndromes. 4. are currently participating in a weight loss program and/or taking weight loss medication or lost \> 5% of body weight during the past 6 months. 5. intend to move to another city within the time frame of the investigation or will be out of town and unavailable for meetings for more than one week during the treatment program. 6. are pregnant, lactating, less than 6 months post-partum, or plan to become pregnant during the time frame of the investigation.
orsiro™ drug eluting stent in routine clinical practice

Conditions: Angioplasty, Transluminal, Percutaneous Coronary; Coronary Artery Disease

Summary: the purpose of this study is to evaluate effectiveness and safety of orsiro™ drug eluting stent in routine clinical practice


Eligibility criteria:
inclusion criteria: * age 20 and more * intervention with orsiro™ drug eluting stent * agreed with written informed consent form exclusion criteria: * intervention with orsiro™ drug eluting coronary stent and other drug eluting stent at the same time * life expectancy of 1year and under * cardiac shock

Keywords: orsiro drug eluting stent routine clinical practice angioplasty, transluminal, percutaneous coronary coronary artery disease
safety and efficacy of at-001 in patients with diabetic cardiomyopathy

Conditions: Diabetic Cardiomyopathies

Summary: this is a multicenter, randomized, placebo-controlled, 2-part study to evaluate the safety and efficacy of at-001 in adult patients (n=675) with diabetic cardiomyopathy at high risk of progression to overt heart failure.

the study consists of two consecutive parts: part a and part b. part a will evaluate the safety and efficacy of two doses of at-001 vs placebo. the primary objective of part a is to demonstrate that at-001 improves or prevents the decline of functional capacity in patients with diabetic cardiomyopathy. part b is an extension of at least 12 months that will evaluate the safety and efficacy of chronic administration of at-001 vs placebo in the same patients who had previously been evaluated in part a. assessments in part b will include safety endpoints and exploratory clinical efficacy endpoints, i.e. death and hospitalization due to a cardiac event.

Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus * diabetic cardiomyopathy * peak vo2 \< 75% of predicted normal value based on age and gender exclusion criteria: * prior diagnosis or signs/symptoms of overt/symptomatic heart failure / stage c heart failure * prior echocardiogrphic measurement of ejection fraction (ef) \< 40% * prior acute coronary syndrome (acs), coronary artery bypass graft (cabg), percutaneous coronary intervention (pci), coronary artery disease (cad) or stroke * severe or moderate cardiac valve disease requiring intervention * clinically significant arrhythmia * prior diagnosis of congenital, infective, toxic, infiltrative, post-partum, or hypertrophic cardiomyopathy * blood pressure \> 140 mmhg (systolic) or \> 90 mmhg (diastolic) at screening * hba1c \>8.5% at screening * severe disease that would impact the performance of a cardio-pulmonary exercise test

Keywords: type 2 diabetes aldose reductase inhibitor stage b heart failure stage c heart failure cardiopulmonary exercise test