Kornimate/medical-research-clean huggingface dataset:
tweens to teens project at penn state

Conditions: Congenital Adrenal Hyperplasia

Summary: the goal of this study is to help investigators to understand more about the development of characteristics related to being male or female (what is called gender development). the investigators will study girls with congenital adrenal hyperplasia (cah) aged 10 to 13 to learn more about the girls' interests and activities, thoughts and feeling about being female, and family relationships. this will help investigators to understand the ways in which gender development is shaped by hormones and family relationships.

interviewers will visit girls in their home when it is convenient for the family. girls will answer questions about the things they do and are interested in, how they think and feel, and complete some cognitive tasks. girls will also provide saliva so we can examine their hormones and determine the cah gene mutation they have. parents will also be asked to complete questionnaires about their own activities and interests and about their daughter's behavior. shortly after the home visit, interviewers will telephone girls and their parents on several days and ask what the girls did during the day.

Eligibility criteria:
inclusion criteria: * girls with classical or non-classical cah due to 21-ohd * girls will be aged 10-13 years at initial recruitment * parents will include biological mothers and fathers as well as step-parents and/or other guardians/significant caregivers * parents/guardians may range in age from 18 years of age to 65 years of age. exclusion criteria: * girls who are not within the age range of 10-13 years old at initial recruitment * cah not due to the 21-ohd form

Keywords: congenital adrenal hyperplasia cah sex differences adolescence androgen behavior gender development
new "in vitro" diagnostic test for oral malodour

Conditions: Halitosis

Summary: this study will assess the ability of a first prototype (strip) of a new chair side test to detect oral malodour. the strip is based on a new enzymatic reaction able to detect amines in saliva. previous studies already showed significant correlations between oral malodor and the levels of amines in saliva. the limitation in their use as markers of oral malodour is the fact that the detection is usually carried out by complex techniques (high performance liquid chromatography(hplc)and solid-phase micro extraction-gas chromatography/mass spectrometry (spme-gc/ms)). the results of the new enzymatic reaction can be evaluated by means of a colorimetric scale without necessity of extra apparatus. the study will be carried out with volunteers recruited at a multidisciplinary consultation for bad breath, organized at the university hospital leuven, belgium. the paper strip will be used before the routine evaluation (organoleptic score (os), the gold standard method for the diagnosis of halitosis and the level of volatile sulphur compounds (vsc), the most used adjunct tool to diagnose halitosis). the results of the new chair side test (strip) will be correlated with the os and vsc measurements (oralchroma™, halimeter®). the sensitivity, specificity and positive and negative predicted values of the new chair side test will be calculated. the cut-off values for a yes/no test will be determined. the meaning of color scores will be analyzed to assign a meaningful outcome to each score with relation to odor intensity.


Eligibility criteria:
inclusion criteria: * adults (≥18 years * with no evidence of bad breath or bad breath of intra-oral cause (oral malodour) * non-smokers or smokers from whom the organoleptic evaluation can be performed (no interference from smoke odour) exclusion criteria: * smokers from whom the organoleptic evaluation can not be performed because of interference from smoke odour * presence of active caries * presence of sinusitis or any other oro-pharyngeal problem * on medications which can cause malodour * reduced salivary flow due to pathological reasons (e.g. sjögren syndrome) * any oral pathophysiological condition or any oral disease (e.g. oral cancer, mucositis) * pregnancy and nursing * situation considered not compatible with the study according to the investigator's opinion; the latter includes: persons under homeopathic therapy, patients who used antibiotics during the 2 months before the study, patients frequently using chewing gum, patients under corticosteroids or other serious medications.

Keywords: oral malodour halitosis subjects consulting a bad breath clinic
investigation of the effect of different training techniques in teaching the management of shoulder dystocia

Conditions: Shoulder Dystocia

Summary: in this study, it was aimed to determine the effect of demonstration, telesimulation and game-based teaching on teaching shoulder dystocia management in midwifery students. h01: there is no difference between the four groups in terms of satisfaction with learning. h02: there is no difference between the four groups in terms of self-confidence in learning. h03: there is no difference between the four groups in terms of motivation scores in teaching materials.


Eligibility criteria:
inclusion criteria: * being a registered student in the midwifery department, * having the ability to manage normal birth, * having a smart phone, tablet or computer with internet connection, * agreeing to participate in the research exclusion criteria: * to suspend education. * having received formal training on shoulder dystocia management.
hemodynamic and echocardiographic assessment of riociguat effects on myocardial wall contractility and relaxation kinetics

Conditions: Hypertension, Pulmonary; Ventricular Dysfunction, Left

Summary: the aim of this study is to assess whether oral riociguat affects the left ventricular contractility and relaxation in patients with pulmonary hypertension associated with left ventricular systolic dysfunction

adverse event data will be covered in adverse events section.

Eligibility criteria:
inclusion criteria: * male and female patients with symptomatic pulmonary hypertension due to left ventricular systolic dysfunction despite standard heart failure therapy exclusion criteria: * types of pulmonary hypertension other than group 2.1 of dana point classification

Keywords: pulmonary hypertension left ventricular dysfunction
safety and feasibility study of targeted temperature management after ich

Conditions: Intracerebral Hemorrhage

Summary: though ttm is ubiquitously used in the neuro-intensive care unit, there is limited experience with the use of ttm after intracerebral hemorrhage (ich), the most devastating type of stroke. ttm may be a an intervention to improve patient outcomes. this trial addresses the safety and tolerability of a protocol of ultra-early ttm after ich/iph and may be the basis for future larger clinical trials.

morbidity and mortality from intra-cerebral/intra-parenchymal hemorrhage (ich/iph) are important public health problems. as the most common etiology of ich/iph is hypertension, this places a large proportion of the population at risk. in 2011 the american heart association (aha) estimated that in the us, there were 610,000 new stroke cases of which 10% were ichs, and many required long-term health care. ich/iph is associated with the highest morbidity and mortality and only 20% of patients regain functional independence. temperature modulation to hypothermia (t, 32-34°c) has been associated with modulation of physiopathologic processes associated with inflammatory activation and degradation of blood-brain barrier after all types of brain injury. currently, there are no therapies to specifically target ich/iph. to this end, novel strategies that go beyond control of glucose, blood pressure, and intra-cranial pressure, aimed at reducing the enlargement of the hematoma and "swelling" surrounding it, could be "the new frontier in the management of ich/iph". since the early resuscitation phase in the neuro-icu represents the greatest opportunity for impact on clinical outcome after ich/iph, it also appears to be the most promising window of opportunity to demonstrate a benefit when investigating novel therapies.

Eligibility criteria:
inclusion criteria: * spontaneous supratentorial ich documented by ct scan within 18 hours after the onset of symptoms * admission to the neuro-icu * baseline hematoma \>15cc with or without ivh * need for mechanical ventilation. exclusion criteria: * gcs \<6 * age \<18 years * pregnancy * pre-morbid modified rankin scale (mrs) \>2 * do not resuscitate (dnr) order "prior" to enrollment * uncontrolled bleeding of different etiology (trauma, gastro-intestinal bleeding \[ugib/lgib\]) * planned surgical decompression within 24 hours * secondary causes of ich (ischemic stroke, coagulopathy \[inr\>1.4, aptt\> 1.5 times baseline, thrombocytopenia platelets \<100,000/ul\], trauma, avm, aneurysm, cerebral sinus thrombosis, or other causes) * evidence of sepsis * spontaneous hypothermia (core temperature \<36c) * inability to obtain written informed consent * participation in another trial.

Keywords: hypothermia normothermia hyperthermia
comparative ultrasound analysis of two hyaluronic acid dermal fillers

Conditions: Volume Deficiency of the Midface

Summary: to assess and compare tissue aggregation and visualization of two hyaluronic acid fillers via ultrasound

this is a randomized, split-face, subject-blinded, comparative study to assess and compare tissue aggregation and visualization of two hyaluronic acid fillers via ultrasound. this study is designed to enroll and randomize approximately 15 subjects in a 1:1 ratio of treatment to restylane contour or juvederm voluma. all subjects are to have midface volume loss and contour deficiency. eligible subjects are randomized to receive treatment were injected by the treating investigator at baseline. the method of injection is at the discretion of the treating investigator. a sufficient amount of product is injected to achieve optimal correction of the midface, in the opinion of the treating investigator and subject. at the 4-week visit, after all study procedures for the visit are completed, treated subjects have the option of receiving a touch-up treatment to achieve optimal aesthetic improvement. at the 6-month, 9-month, and 12-month visits, similar study procedures are performed.

Eligibility criteria:
inclusion criteria: * subject with midface volume loss and contour deficiency * ability of giving consent for participation in the study * agreement to adhere to the procedures and requirements of the study and to report to the institute on the day(s) and at the time(s) scheduled for the assessments exclusion criteria: * history of allergy or hypersensitivity to lidocaine and/or injectable hyaluronic acid * previous permanent or semi-permanent implant in proposed treatment area * previous biodegradable tissue augmentation therapy in the proposed treatment area within 12 months prior to the baseline visit * history of other facial treatment/procedure at the study area (midface) in the previous 6 months that would potentially interfere with study injections (e.g., facial surgery, oral surgery, resurfacing, mesotherapy, lipolytic injections, botulinum toxin injections)
ag-73305 single ascending dose cohort study in dme

Conditions: Diabetic Macular Edema

Summary: this is a multi-centered, open-labeled, single ascending-dose-cohort study to evaluate 4 dosing cohorts of ag-73305 administered by intravitreal injection in patients with diabetic macular edema (dme).


Eligibility criteria:
inclusion criteria: 1. male or female, 18 years of age or older at the screening visit 2. prior diagnosis of diabetes mellitus (type 1 or type 2) as defined by world health organization or american diabetes association 3. presence of center-involving dme in the study eye with cst ≥ 325 μm 4. visual acuity loss in the study eye attributed to dme with screening and baseline etdrs bcva letter score of 20 to 55 (20/400 to 20/80 snellen equivalent) in the sentinel patients and 35 to 70 (20/200 to 20/40 snellen equivalent) in the non-sentinel patients exclusion criteria: 1. uncontrolled diabetes mellitus, defined as hemoglobin a1c \> 12.0% at screening 2. uncontrolled hypertension with systolic blood pressure ≥ 180 mmhg and/or diastolic blood pressure ≥ 100 mmhg at screening or baseline 3. chronic renal disease 4. any active infection in either eye 5. any anti-vascular endothelial growth factor (vegf) treatment in the study eye within 6 to 8 weeks prior to baseline 6. use of ozurdex (dexamethasone) within 6 months prior to baseline or any use of iluvien (fluocinolone acetonide) in the study eye 7. uncontrolled intraocular pressure (iop), defined as an iop \> 25 mmhg, despite anti-glaucoma medications in the study eye at the time of screening or controlled glaucoma that requires management with \> 2 topical hypotensive medications
pharmacokinetics of spi-2012 (eflapegrastim) in breast cancer patients receiving docetaxel and cyclophosphamide (tc) chemotherapy

Conditions: Breast Cancer; Pharmacokinetics

Summary: the purpose of this study is to evaluate the pharmacokinetic (pk) profile of a fixed dose of spi-2012 in patients with early-stage breast cancer receiving docetaxel and cyclophosphamide (tc) chemotherapy, as measured by the serum concentration of spi-2012 on specific days following drug administration.

this is a phase 1, single-arm multicenter study to evaluate the pk and safety of spi-2012 (a long acting myeloid growth factor) in breast cancer patients treated with tc chemotherapy. approximately 25 patients will be enrolled. each cycle will be 21 days and patients will receive 4 cycles of treatment with 2 additional cycles based on the investigator's discretion. on day 1 of each cycle, patients will receive tc chemotherapy and on day 2 of each cycle, patients will receive spi-2012. pharmacokinetics will be evaluated only in cycles 1 and 3.

Eligibility criteria:
inclusion criteria: * newly diagnosed, histologically confirmed early-stage breast cancer, defined as operable stage i to stage iiia breast cancer. * candidate to receive adjuvant or neoadjuvant tc chemotherapy. * anc ≥1.5x10\^9/l * platelet count ≥100x10\^9/l * hemoglobin \>9 g/dl * calculated creatinine clearance \>50 ml/min * total bilirubin ≤1.5 mg/dl * ast and alt ≤2.5xuln * alkaline phosphatase ≤2.0xuln * ecog ≤2 exclusion criteria: * active concurrent malignancy (except non melanoma skin cancer or carcinoma in situ of cervix) or life-threatening disease. if history of prior malignancies or contralateral breast cancer, must be disease free for at least 5 years. * known sensitivity to e. coli derived products or known sensitivity to any of the products to be administered during dosing. * concurrent adjuvant cancer therapy. * locally recurrent/metastatic breast cancer. * previous exposure to filgrastim, pegfilgrastim, or other g-csf products in clinical development within 12 months prior to the administration of study drug. * active infection, receiving antibiotics or any serious underlying medical condition which would impair the ability of the patient to receive protocol-specified treatment. * prior bone marrow or hematopoietic stem cell transplant * used any investigational drugs, biologics, or devices within 30 days prior to study treatment or plans to use any of these during the course of the study. * prior radiation therapy within 30 days prior to enrollment. * major surgery within 30 days prior to enrollment.

Keywords: breast cancer pharmacokinetics long-acting myeloid growth factor early stage breast cancer docetaxel + cyclophosphamide (tc) chemotherapy
a study comparing pegylated rhg-csf and rhg-csf as support to breast cancer patients receiving chemotherapy

Conditions: Breast Cancer; Neutropenia; Febrile Neutropenia

Summary: neutropenia is one of the most frequent adverse effects of chemotherapy, and the main factor to limit the dosage and the continuation of chemotherapy. a newly pegylated rhg-csf was independently developed by jiangsu hengrui medicine co., ltd, china. phase 1a, 1b and phase 2 trials have shown that pegylated rhg-csf has decreased renal clearance, increased plasma half-life, and prolonged efficacy in compare with rhg-csf. the purpose of this study is to determine the safety and effectiveness of pegylated rhg-csf in preventing neutropenia following chemotherapy in patients with breast cancer.


Eligibility criteria:
inclusion criteria: * investigator diagnosis of breast cancer * age 18 to 70 years * ecog performance status ≤ 1 * chemotherapy naïve * body weight ≥ 45kg * hemoglobin ≥ 90g/l; white blood cell ≥ 4.0×109/l; absolute neutrophil count ≥1.5 × 109/l; platelet count ≥ 100 × 109/l * alanine transarninase ≤1.5×uln; aspartate aminotransferase ≤1.5×uln; serum creatinine ≤1.5×uln; total bilirubin ≤1.5×uln exclusion criteria: * prior bone marrow or stem cell transplantation * received systemic antibiotics treatment within 72 h of chemotherapy * radiation therapy within 4 weeks of randomization into this study * pregnancy, lactation

Keywords: breast cancer neutropenia febrile neutropenia
long-term safety study of treatment with the thrombopoietin agonists eltrombopag and romiplostim in patients with immune thrombocytopenia (itp)

Conditions: Idiopathic Thrombocytopenic Purpura

Summary: thrombopoietin receptor agonists (tpo-ra) are novel treatment modalities for patients with refractory primary immune thrombocytopenia (itp), but only few data are available for long-term effects of these drugs. in this observational study, effects and adverse effects including evaluation of bone marrow biopsies done at fixed intervals will be recorded from itp patients treated with tpo-ra. for some patients, blood samples will be collected for research use.


Eligibility criteria:
inclusion criteria: * adult patients with itp * platelet counts \< 25 x10\*9/l or \< 50 x10\*9/l with bleeding symptoms * meets criteria for treatment with tpo-ra * females must use contraceptives when applicable for at least three months before inclusion exclusion criteria: * pregnancy or nursing * former thromboembolic events excluding one incidence of deep venous thrombosis as complication to surgery or pregnancy or one incidence of cerebral embolism as complication to atrial fibrillation * liver insufficiency (for eltrombopag only) * tpo-ra contraindications (e.g. allergy) * tpo-ra treatments less than 6 months prior to inclusion

Keywords: itp romiplostim eltrombopag bone marrow fibrosis long-term safety
measuring endometrial blood flow using laser doppler: acceptability & reproducibility

Conditions: Endometrium; Vascularization

Summary: 35 participants will be recruited from a list of patients who are scheduled, as part of their routine nhs care, to have a clinically-indicated outpatient hysteroscopy for assessment of their uterine cavity. the participants will be women from the age of 18 up to the age of 40 who are undergoing hysteroscopy investigation. all participants included in the study require at least one ultrasound scan, within the preceding 5 years, demonstrating the presence of a normal uterine cavity devoid of uterine anomalies such as a septate uterus or intrauterine fibroids (which may affect endometrial blood flow measurements). it is usual for a patients to have an ultrasound assessment prior to hysteroscopy therefore we do not anticipate this requirement limiting the number of eligible participants available.

patient registry: recruited patients will be registered on 'edge', a secure, password-protected, database for study participants. all the investigators will comply with the requirements of the gdpr 2018 with regards to the storage, processing and disclosure of personal information and will uphold the act's core principles. access to patient-identifiable data will be restricted to the core patient-facing members of the research team at birmingham women's and children's hospital. the patient-facing members will be the chief investigator (me), the principal investigator (jc), and co-investigator (hh). the study involves depersonalised data and the data will be maintained within secure servers. the birmingham women's hospital research and development department will hold an archived copy of the study data. the chief investigator (me) and the principal investigator (jc) will act as data custodians and keep the site file locked away securely with restricted access to study data for 25 years. only the aforementioned members of the research team will have access to the site file for the purpose of quality control, audit and analysis. coded, depersonalised data will be created and used for study documents, in place of participant-identifying information. the participant data within the study and the code linking this data to the individual's true identity and identifiable data will be kept in separate locations using encrypted digital files within password-protected folders and storage media

Eligibility criteria:
inclusion criteria: * women from the age of 18 up to the age of 40 who have consented to hysteroscopy investigation as part of their standard nhs care. * women who have had an ultrasound scan, within the preceding 5 years, demonstrating a normal uterine cavity with no gross anatomical abnormalities (e.g. uterine septum). * women who have given informed consented to take part in the study exclusion criteria: * inability to tolerate vaginal examinations * women who are pregnant * women who do not have regular menstrual cycles * women who have not given consent to the study.