Kornimate/medical-research-clean huggingface dataset:
angular pregnancy - ultrasound definition and correlation with clinical outcomes

Conditions: Miscarriage in First Trimester

Summary: the aim of this study is to establish clinically meaningful ultrasound-based diagnostic criteria for ap. to this end, the investigators will prospectively collect clinical and ultrasound data from early intrauterine pregnancies and correlate this data with pregnancy outcomes (particularly with risk of miscarriage), to establish whether there are any diagnostic criteria that can be used to make the diagnosis, facilitate increased surveillance of at risk pregnancies and reassure those with normally located pregnancies. the collected data will be used to correlate incidence of angular pregnancy and clinical variables such as maternal age, uterine fibroids, assisted conception, multiple pregnancy, ethnicity, previous uterine and adnexal surgery.


Eligibility criteria:
inclusion criteria: * have capacity to understand the study and to provide signed and dated informed consent. * willing to comply with all study procedures and be available for the duration of the study including consenting to follow up of the pregnancy outcome by letter, phone or email according to individual preference. * age 16 years or over * mean gestational sac diameter (gsd) on ultrasound of 2-15mm inclusive * gs implantation site within the upper half of the uterine cavity on 2d uss exclusion criteria: * women with pregnancies of unknown location, ectopic pregnancies or larger gsd than specified in the inclusion criteria. * implantation site within the lower half of the endometrial cavity on 2d uss screening. * intention to terminate the pregnancy * women with unicornuate uteri or unicornuate uteri with rudimentary horns * women with uterine fibroids which distort the uterine cavity
a phase 2 study to evaluate the safety, tolerability, pk and pd in cystic fibrosis patients with at least 1 g542x allele

Conditions: Cystic Fibrosis

Summary: this is a phase 2 open label study to evaluate the safety, tolerability, pk, and pd of multiple dose levels of sc administered elx-02 with and without ivacaftor in patients with cf with at least one g542x allele or phenotypically similar nonsense allele. up to 16 patients will be enrolled in the trial; up 4 patients will be homozygotes to g542x, and the remaining patients will be compound heterozygotes with g542x or phenotypically similar nonsense mutation and any class 1 or class 2 mutation. each patient will receive 5 escalating doses as follows: * 0.3 mg/kg per day sc * 0.75 mg/kg per day sc * 1.5 mg/kg per day sc * an individualized dose, as high as 3.0 mg/kg per day sc, based upon the patients observed safety and tolerability, pk at previous doses and the results of laboratory tests * elx-02 1.5 mg/kg per day sc plus 150 mg ivacaftor every 12 bid


Eligibility criteria:
patients must meet the following criteria to participate in this study: 1. males and females age 18 years and above in germany and israel; in countries where permitted, males and females age 16 years and above 2. a confirmed diagnosis of nmcf with a documented g542x or phenotypically similar nonsense mutation, homozygote, or compound heterozygote with one of the specified mutations. for heterozygotes, one mutation has to be g542x or phenotypically similar nonsense mutation, and the second mutation could be and class 1 or class 2 mutation. patients with one g542x or phenotypically similar nonsense allele and a second allele that is not in the above list may be potentially allowed but only after discussion on a case by case basis with and written approval from the sponsor. 3. documented scc ≥ 60 meq/l 4. fev1 ≥ 40% predicted normal for age, gender and height at screening (knudson equation) 5. body mass index (bmi) of 19.0 to 30.0 kg/m2 (inclusive). patients with any of the following characteristics/conditions will not be included in the study: 1. participation in clinical study including administration of any investigational drug or device in the last 30 days or 5 half-lives (whichever is longer) prior to investigational product dosing in the current study 2. history of any organ transplantation 3. major surgery within 180 days (6 months) of screening 4. patients without documented prior aminoglycoside exposure who have a mitochondrial mutation that has been shown to increase sensitivity to aminoglycosides 5. known allergy to any aminoglycoside 6. patients with any abnormality at ent screening, that indicates the presence of a vestibular toxicity associated with prior exposure to aminoglycosides. 7. dizziness handicap inventory (dhi)-h score at screening \>16 8. patients receiving cftr modulators within 2 months of study treatment

Keywords: aminoglycoside nonsense mutation translational read through
investigation of two different i̇nterventions i̇n hemiplegic patients

Conditions: Stroke; Physiotherapy and Rehabilitation

Summary: background: our study aims to determine the effect of relaxation and breathing exercises in addition to the treatment procedure on depression level, sleep quality, and spasticity in hemiplegic patients. methods: thirty patients aged 40-70 years diagnosed with hemiplegia were included in the study. all patients received the same bobath exercise three days a week for six weeks. patients in group 2 additionally received breathing and relaxation exercises. sleep quality assessment by pittsburgh sleep quality index (puki), depression by hospital anxiety and depression scale (hads), and spasticity by modified ashworth scale (mas) were used. all assessments were made at baseline and six weeks after exercise treatments.


Eligibility criteria:
inclusion criteria: * the study included patients who met the following inclusion criteria: * having had a stroke at least six months ago, * possessing adequate cognitive functions, * having no pre-existing sleep problems before the disease, * absence of emotional disturbance prior to the disease, * voluntary participation in the study, * no cardiovascular problems, * having a score of 1, 1+, or two according to the modified ashworth scale exclusion criteria: * having a traumatic stroke caused by malignancy or other organic factors, alcohol or drug addiction, * having a score of 3 or 4 according to the modified ashworth scale

Keywords: depression exercise relaxation pain
role of prohepcidin in uremic patients

Conditions: Inflammation; Chronic Kidney Disease

Summary: the investigators aimed to study the effect of prohepcidin levels on hematologic parameters and inflammatory markers in non-diabetic uremic patients. the investigators selected three groups of patients: hemodialysis group, peritoneal dialysis group and the group with stage 4 chronic kidney disease. a control group was formed from healthy volunteers also. each group has been planned to be formed of about 25 patients. diabetic patients were excluded. prohepcidin, hscrp, il-6, fibrinogen have been planned to be studied besides other routine biochemical analysis including hematological ones.


Eligibility criteria:
inclusion criteria: * hemodialysis and peritoneal dialysis patients who had been on dialysis therapy for more than 3 months, * age between 18-80 years, * patients with creatinine clearance between 15-30 ml/min. exclusion criteria: * age less than 18 or more than 80, * diabetic patients, * current active infectious or inflammatory disease.

Keywords: hemodialysis inflammation iron peritoneal dialysis prohepcidin uremia
comparison amongst scleral, corneal and amniotic membrane grafts to restore scleral thinning

Conditions: Scleral Thinning

Summary: the purpose of this study is to evaluate the use of preserved scleral, corneal and amniotic membrane graft for the surgical repair of scleral thinning of different sizes in patients underwent surgery of pterygium with associated beta therapy .

scleral thinning may occur secondary to different ocular surface conditions, especially in rheumatologic diseases and after surgeries as in pterygium. there are different methods to treat this condition, as to use scleral, corneal and more recently amniotic membrane graft.

Eligibility criteria:
inclusion criteria: * patients with corneal scleral defects that have persisted for 1 years or longer, regardless of their cause. these patients will have received corneal-scleral or amniotic membrane transplant in order to correct scleral thinning * patients with history of pterygium surgery associated with beta therapy followed by scleral thinning exclusion criteria: * ocular infection * acute ocular inflammatory condition * previous ocular surgery in the eye study * non-controlled systemic disease such as rheumatoid arthritis

Keywords: amniotic membrane cornea scleral thinning
iodine supplementation and fertility parameters

Conditions: Infertility (IVF Patients)

Summary: iodine has been identified as a potential factor influencing female fertility during the childbearing years. the american thyroid association recommends that women attempting to conceive take a supplement containing 150 µg of iodine. however, no clinical trials have specifically examined the necessity of iodine supplementation in women experiencing infertility. furthermore, no information is available on the optimal dose and duration of iodine supplementation to increase the chances of successful treatment in this group of women. therefore, this study aims to investigate the effects of iodine supplementation on fertility parameters in infertile women.

this double-blind randomized clinical trial will be conducted in infertility clinic on women with diminished ovarian reserve and undergoing in vitro fertilization (ivf) cycle treatment. according to the bologna criteria, decreased ovarian reserve is defined as having 3 to 5 antral follicles and an anti-müllerian hormone concentration ranging from 0.1 to 1.5 ng/ml. all women diagnosed with diminished ovarian reserve who meet the inclusion and exclusion criteria outlined in the general information section of the clinical trial and have provided written consent to participate will be examined. following enrollment and baseline measurements, women will be randomly assigned to treatment groups-placebo and iodine supplement (150 µg/day of iodine)-in a 1:1 allocation ratio, using a random number table. in the intervention group, women will take 150 µg of iodine daily (one tablet per day, tavan institute, tehran, iran) for two months prior to starting the new ivf cycle. in the control group, participants will take a placebo tablet daily (containing white wheat flour, designed to match the size, shape, and color of the iodine tablet, tavan institute, tehran, iran) for the same duration before beginning the new ivf cycle. women of two groups will be followed until the end of ivf cycle. women in both groups will be monitored until the completion of the ivf cycle. throughout the study, the following parameters will be assessed based on the timeline of the ivf cycle: the number of retrieved oocytes, the number of mature (mii) oocytes, the number of embryos, embryo quality, biochemical pregnancy, and clinical pregnancy.

Eligibility criteria:
inclusion criteria: * women with diminished ovarian reserve * willingness to participate * age range: 18 to 45 years * women with a menstrual cycle of 21 to 42 days * women who have not used any contraceptive methods in the past 12 months * women who have not had in sexual intercourse for more than 2 months exclusion criteria: * unwillingness to participate * women with polycystic ovary syndrome or endometriosis * diagnosis of any thyroid disease * use of any medication that affects the thyroid function * use of dietary supplements containing iodine (excluding those considered in the present study) * use of iodine-containing disinfectants
evaluation of a psychotherapeutic intervention model in nursing

Conditions: Anxiety

Summary: this study aims to evaluate the efficacy of a psychotherapeutic intervention model in nursing on the nursing diagnosis "anxiety". a randomised controlled trial will be carried out to do so.

this study aims to evaluate the efficacy of a psychotherapeutic intervention model in nursing on nursing diagnosis "anxiety" (according to international classification for nursing practice (icnp)/north american nursing diagnoses association (nanda) standardized nursing language). a randomised controlled trial will be carried out to do so. in a single-blinded nurse-led 6 months controlled trial, conducted at a hospital outpatient setting in portugal, approximately 60 patients with anxiety will be randomised to the intervention (n=30) or control groups (n=30). the objective is to compare the outcomes associated with "treatment-as-usual" and the benefits of implementing the psychotherapeutic intervention model in nursing previously developed (5 sessions), which will be evaluated using nursing outcomes classification (noc) outcomes "anxiety level" and "anxiety self-control" (portuguese version).

Eligibility criteria:
inclusion criteria: * 18-64 years old; * nursing diagnosis "anxiety" (according to icnp/nanda standardized nursing language) - assessment using noc outcome "anxiety level" (portuguese version); * elementary education (completed). exclusion criteria: * psychiatric diagnosis of dementia or psychotic spectrum disorder; * being in therapy provided by a psychologist (at the moment of the session 0); * cognitive impairment (assessment using mini-mental state examination); * moderate or severe intellectual disability; * confusional state; * psychomotor agitation.

Keywords: psychotherapy nursing nursing care nursing model randomised controlled trial
topical versus intravenous tranexamic acid in total knee arthroplasty

Conditions: Arthrosis

Summary: this clinical trial investigated two different routes of administration of tranexamic acid in total knee arthroplasty: topical compared to intravenous.

intravenous administration of tranexamic acid (ta) is common in orthopedic surgery. the ideal dose and administration route of the drug in total knee arthroplasty (tka) is under investigation. the objective of this randomized clinical trial was to verify differences between topical and intravenous administration of ta in tka regarding blood loss and coagulation variables. patients undergoing tka were randomized to receive ta intravenously (20 mg in 100 ml of saline), topically (1.5 g in 50 ml of saline, sprayed over the operated site, before closure) or intravenous saline (100 ml). suction drains were maintained for 48 hours, in order to measure blood loss. data analysis is being undertaken now, in order to compare the two routes of administration of the drug.

Eligibility criteria:
inclusion criteria: patients in need of unilateral total knee arthroplasty (tka) due to arthrosis, albach grades iii and iv were eligible exclusion criteria: * history or identified risk for deep vein thrombosis or pulmonary embolism * history of coagulation or cardiovascular disorders * vascular diseases * pregnancy * current use of anticoagulation drugs * previous orthopedic surgery in the legs.

Keywords: arthroplasty, replacement, knee tranexamic acid drug administration routes
cancer-associated gene mutations in cml treatment with tkis by ngs

Conditions: Different Gene Between Different TKIs Effection

Summary: we performed targeted-capture sequencing of 127 known and putative cancer-related genes of patients who best effect to tkis ,or intolerance to tkis,or resistance to tkis by next-generation sequencing (ngs) .


Eligibility criteria:
inclusion criteria: 1. chronic myeloid leukemia-chronic phase(cml-cp) patients treated with receivetyrosine kinase inhibitor -tki(including imatinib, dasatinib and nilotinib) for more than 1 years 2. best effect to tkis ,or intolerance to tkis,or resistance to tkis according to q-pcr detected bcr/abl(is) in peripheral blood and hematologic response and cytogenetic response 3. informed consent of the patient or his legal representative exclusion criteria: 1. patients had history of cml-ap or cml-bc 2. cml patients who have received allogeneic hematopoietic stem cell transplantation 3. cml patients who have received immunotherapy (except interferon, including car-t and other cellular immunotherapy) 4. woman who is pregnant or nursing
real-world outcomes of us talazoparib-treated patients with locally advanced or metastatic breast cancer

Conditions: Breast Cancer

Summary: this study is a retrospective, multi-site, patient-level medical chart review of us adult patients with locally advanced or metastatic breast cancer (abc) who initiated talazoparib on or after october 16, 2018 and were managed by participating providers from cardinal health's oncology provider extended network (open). this study will describe patient characteristics, treatment patterns, and clinical outcomes of talazoparib-treated patients in real-world practice setting in us. the primary population for this study includes: -her2-negative abc patients with germline brca1/2 (gbrca1/2) mutations treated with talazoparib monotherapy initiated on or after october 16, 2018 and ≥18 years of age at initiation of talazoparib.


Eligibility criteria:
inclusion criteria: * diagnosed with her2-negative abc * gbrca1/2 mutation(s) * treatment with talazoparib monotherapy initiated on or after october 16, 2018 -≥18 years of age at initiation of talazoparib * a minimum of 6 months follow-up time after initiation of talazoparib unless the patient died within this follow-up period exclusion criteria: * participation in any bc clinical trial after initiation of talazoparib * treatment with a parp inhibitor as neoadjuvant/adjuvant therapy * gbrca1/2 or her2 status unknown * diagnosis of any other malignancy, except carcinoma in situ or nonmelanoma skin cancer, within the 5 years prior to data collection

Keywords: talazoparib breast cancer
symbicort rapihaler therapeutic equivalence study

Conditions: Bronchial Asthma

Summary: the purpose of the this study is to evaluate the efficacy and safety of 2 actuations symbicort®pmdi® 40/2.25 μg twice daily compared with1 inhalation symbicort turbuhaler® 80/4.5 μg twice daily and 1 inhalation pulmicort®turbuhaler® 100 μg twice daily for 6 weeks.


Eligibility criteria:
inclusion criteria: * asthma clinically diagnosed since at least 6 months. * lung function values measured ≥ 50% and ≤ 90% of predicted normal. * patients with reversible airway obstruction daily use of inhaled steroids (any brand) for \>3 months. exclusion criteria: * use of oral, rectal or parenteral steroids within 30 days prior to start of study. * respiratory infection affecting the asthma, as judged by the investigator, within 30 days prior to start of randomised treatment. * any significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or may influence the results of the study or the patient's ability to participate in the study.

Keywords: asthma symbicort
post-marketing study to supplement data on safety, tolerability and efficacy of micardis® with special emphasis on the control of blood pressure

Conditions: Hypertension

Summary: this post-marketing surveillance study is designed to supplement under conditions of normal clinical practice data on safety, tolerability and efficacy of micardis® collected in clinical studies with special emphasis on the control of blood pressure in the morning before intake of the next antihypertensive drug


Eligibility criteria:
inclusion criteria: * essential hypertension * at least 18 years of age exclusion criteria: * na
a single-center, interventional diagnostic study with minimal risks and constraints, aimed at longitudinally evaluating serum antibody levels in patients with covid-19 according to the severity of their symptoms.

Conditions: COVID-19

Summary: the covert protocol was designed to assess, through a longitudinal analysis, the level of antibodies present in the serum of patients with covid-19, the duration and the persistence of the humoral response in correlation with the severity of the disease.


Eligibility criteria:
inclusion criteria: * age ≥18 years old, * patient whose covid-19 diagnosis has been confirmed by rt-pcr test (sars-cov-2 positive) from a nasopharyngeal swab/broncho alveolar lavage * patient whose severity of covid-19 required hospital treatment * patient whose covid-19 form is defined as moderate (stay in general ward) or severe (stay in icu), based on the clinical evaluation conducted by the doctor * patient agreeing to participate in the study and having signed the informed consent. exclusion criteria: * adult person subject to legal protection, * pregnant, parturient or breastfeeding woman * person not affiliated to a social security scheme or not beneficiary of such a scheme * person subject to a safeguard measure * person deprived of liberty by a judicial or administrative decision and woman hospitalized without consent under articles l.3212-1 and 3213-1, which do not fall under article l.1122-8 of the public health code.
efficacy of repaglinide in subjects with type 2 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 2

Summary: this trial is conducted in europe. the aim of this trial is to compare the efficacy of repaglinide to glyburide and placebo on hepatic glucose metabolism in subjects with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * type 2 diabetes * hba1c (glycosylated haemoglobin a1c) above 7 % * bmi (body mass index) below 32 kg/m\^2 * fbg (fasting blood glucose) after wash out period 130-220 mg/dl * currently treated with diet or oha (oral hypoglycaemic agent) exclusion criteria: * current systemic treatment with concomitant medication * known or suspected history of drug or alcohol dependence * any other significant concomitant disease such as cerebrovascular or symptomatic peripheral vascular disease, malignant, disease or severe treated or untreated hypertension * hepatic disease * cardiac problems * active proliferative retinopathy * known or suspected allergy to trial product or related products * women in fertile age and women having the intention of becoming pregnant * body mass index (bmi) above 32 kg/m\^2