Kornimate/medical-research-clean huggingface dataset:
preference and goal directed attention deficit hyperactivity disorder care- pilot study

Conditions: Attention Deficit Hyperactivity Disorder

Summary: this pilot intervention study will test the feasibility and acceptability and explore the outcomes of an urban, primary care-based intervention to measure families' preferences and goals for attention-deficit/hyperactivity disorder (adhd) treatment and structure clinical care to reach these goals.

the intervention includes provision of enhanced, culturally appropriate education about adhd and its treatment, completion of a validated preference and goal instrument, use of this instrument in the adhd treatment decision-making process, and tracking of preferences and goals over time.

Eligibility criteria:
inclusion criteria: * all interested non-trainee clinicians at study sites * parents/legal guardians of children age 6-12, in k-6 grade, diagnosed with adhd. exclusion criteria: * child diagnosed with autism or a psychotic disorder * parents non-english speaking * parents unable to provide consent * pediatric residents

Keywords: attention deficit hyperactivity disorder adhd preferences goals decision making
feasibility study of stereotactic body radiotherapy (sbrt) for localized prostate cancer: cyberknife vs. vmat

Conditions: Prostatic Neoplasms

Summary: recent studies support the use of stereotactic body radiation therapy (sbrt) for the treatment of localized prostate cancer (prca). sbrt is a way to deliver radiation very precisely allowing higher doses to be delivered with fewer treatments, potentially improving patient outcomes. cyberknife and volume modulated arc therapy (vmat) are accepted sbrt techniques. however, the effects of the specific sbrt treatment technique on patient outcomes have not been evaluated in randomized trials. although such a trial would be of great interest, patients' willingness to participate is unclear. multiple patient and clinician factors contribute to the decision to enter a randomized trial. this feasibility study will evaluate patients' willingness to participate in a trial comparing cyberknife and vmat sbrt for the treatment of early stage prca. patients accepting enrolment will be randomized to one of the two types of sbrt delivery. up to 66 patients will be approached, and up to 40 randomized. a questionnaire will help to identify the factors influencing the patient's decision to participate or not. this study will gather information on feasibility, psa control, patient outcomes and side effects, and will inform the design of a future randomized phase ii/iii study.


Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of adenocarcinoma of the prostate * histological evaluation of prostate biopsy with assignment of a gleason score to the biopsy material; gleason scores ≤ 7 * clinical stage t1-2b (ajcc 7th edition) * psa ≤ 10 ng/ml. psa should not be obtained within 10 days after prostate biopsy. * ecog performance status 0-1 exclusion criteria: * prior or concurrent invasive malignancy (except non-melanomatous skin cancer) or lymphomatous/hematogenous malignancy unless continually disease free for a minimum of 5 years. * evidence of distant metastases * regional lymph node involvement * previous radical surgery (prostatectomy), cryosurgery, or hifu for prostate cancer. previous pelvic irradiation, prostate brachytherapy, or bilateral orchiectomy * previous hormonal therapy, such as lhrh agonists or lhrh antagonists, anti-androgens, estrogens, or surgical castration * use of finasteride or dutasteride within 30 days prior to registration. psa should not be obtained prior to 30 days after stopping finasteride or dutasteride. * previous or concurrent cytotoxic chemotherapy for prostate cancer * age \< 18 * patient unable to provide study-specific informed consent * inability to complete the expanded prostate cancer index composite (epic) questionnaire
individualized vestibular rehabilitation for elderly with self-management and gaming elements

Conditions: Vestibular Disorder; Balance; Distorted; Vestibular Diseases

Summary: the aim of this study is to test whether when using the vestibular rehabilitation app older patients perform rehabilitation in a similar manner as when directly instructed by a clinician. a secondary goal is to evaluate usability and enjoyment of the app.

the main aim of this study is to test the prototype vestibular rehabilitation app (that has been specifically developed for this study) in the lab setting to evaluate if patients perform exercises with the app in a similar manner as when performing exercises in the traditional manner without the app. errors in exercise performance identified by the app will be compared to those identified by a physical therapist. a secondary aim is to get feedback on enjoyment and ease of use of the vestibular rehabilitation app.

Eligibility criteria:
inclusion criteria: * aged between 60 and 75 * presence of dizziness due to a central or peripheral vestibular disorder exclusion criteria: * presence of neurological disease such as stroke, multiple sclerosis, parkinson's * history of recent lower extremity surgery or severe pain in legs

Keywords: balance telehealth physical therapy mobile application serious gaming rehabilitation vestibular dizziness
evaluation of the effect of sevoflurane and propofol hypotensive anesthesia on blood antioxidant levels and hif 1 levels

Conditions: Hypoxemia During Surgery; Hypoxia

Summary: the aim of this study to evaluate the patients who underwent controlled hypotensive anesthesia under standardized depth of anesthesia with total intravenous anesthesia or inhalation anesthesia; preoperative and 30. ,60. ,120. second of intraoperative period blood hif 1a, tas, tos measurement and to investigate tissue hypoxia secondary to hypotensive anesthesia and the changes of the mediators at the tissue level and which hypotensive anesthesia technique is related.

controlled hypotension is the voluntary reversible reduction of arterial blood pressure. hypotensive anesthesia is a method of anesthesia in which blood pressure is reduced in a controlled manner, especially in certain surgeries. i̇t reduces intraoperative bleeding and need for blood transfusion and provides a clean surgical vision in narrow-field surgeries or with high bleeding potential. hypotensive anesthesia can be performed according to mean blood pressure (mbp) or systolic blood pressure (sbp). a non-invasive cerebral oximeter is used to see the changes in the brain due to high oxygen-dependent metabolism during induction and maintenance of anesthesia. hypoxia inducible factor (hif) is a transcription factor involved in cell adaptation mechanism activated in response to hypoxia. the biological activity of hif 1 is determined by the expression and activity of the hif 1a subunit. total antioxidant status (tas) shows the total effect of all antioxidants in the human body and total oxidant status (tos) shows the total effect of oxidants. near infrared spectroscopy (nirs) allows continuous and non-invasive monitoring of cerebral oxygenation. hif 1a, tas and tos are laboratory markers that predict tissue oxygenation and perfusion. hypotensive anesthesia can be performed according to both mbp and sbp. however, in our study that follow-up mbp is more advantageous/protective, although it is not supported by very strong data. the investigators recommend hypotensive anesthesia compared to mbp; but further studies are needed

Eligibility criteria:
inclusion criteria: * 18-55 years old * asa physical status classification system 1 * undergoing to elective rhinoplasty exclusion criteria: * patients have any autoimmune disease * smoking of patients * development of any allergic reaction during the procedure * failure to collect blood to be examined at the appropriate time * body mass index is less than 19 or greater than 30 termination criteria * development of severe hypotension and bradycardia during measurements * development of severe drug allergy during follow-up * in the event of any complications related to the surgical procedure

Keywords: hypotensive anesthesia hif 1a total intravenous anesthesia inhalation anesthesia
validation of therapeutic effects of cefaly on insomnia

Conditions: Sleep Initiation and Maintenance Disorders

Summary: the study aims to examine whether the cefaly has a therapeutic effect on insomnia patients visiting a psychiatric clinic in korea. the study design is a single site, single-armed exploratory study. insomnia patients received a 20-minute daily sessions of the cefaly for 4 weeks. primary endpoint was a reduction of scores in pittsburgh sleep quality index, insomnia severity index, epworth sleepiness scale, improvements in polysomnography measures, and changes in resting state networks, cortical thickness, fractional anisotropy and mean diffusivity

insomnia is well-known for its association with adverse health outcomes. although insomnia is usually treated with hypnotics or cognitive behavioral therapy for insomnia, the need for novel nonpharmacological treatment for insomnia is increasing emphasized due to reports of side effects and detrimental consequences of hypnotics. trigeminal nerve electrical neuromodulation has been suggested as a potential treatment modality through its modulation of noradrenergic activity that results in promoting relaxation and reducing hyperarousal. insomnia patients enrolled in the study will go through a 20-minute daily session of the cefaly device(originally fda-approved device for migraine, which electrically modulates trigeminal nerve) for 4 weeks. the objective of this study is to test whether trigeminal nerve electrical neuromodulation has a therapeutic effect, validation measures involving subjective measures(pittsburgh sleep quality index, insomnia severity index, epworth sleepiness scale), objective measures(polysomnography measures) and neuroimaging(changes in resting state networks, cortical thickness, fractional anisotropy and mean diffusivity).

Eligibility criteria:
inclusion criteria: 1. patients who have adequately understood the whole study procedures within age range of 19-64 years 2. patients with insomnia severity index (isi) score of more than 15 exclusion criteria: 1. cognitive impairment 2. psychiatric disorders or neurological disorders. 3. unstable medical conditions 4. prior diagnosis of sleep disorders 5. hypnotic prescription 6. history of brain or facial trauma within 3 months 7. skin abrasions 8. acrylic acid allergy 9. electromagnetic hypersensitivity 10. apnea hypopnea index of \>15/hour in the baseline polysomnography.
investigation of the effects of cgf and a-prf on pain, edema and trismus after impacted lower third molar surgery

Conditions: Trismus; Edema; Pain; Post-Op Complication

Summary: the objective of this case-control intervention study is to explore the effectiveness of concentrated growth factor (cgf) and advanced platelet rich fibrin (a-prf) on pain, edema and trismus after impacted lower third molar surgery

in the present study, 75 patient, whose ages ranged between 18-30 and have an impacted lower third molar which is in vertical or mesiyoangular position and has class i and ii ramus relationship and class b and c depth, will included. 75 patient will divided randomly into three groups as cgf, a-prf and control. after third molar surgery cgf and a-prf will prepared and applied to the extraction sockets in cgf and a-prf groups. nothing will applied to the control group. post operative pain, edema and trismus will measured at 2nd and 7th days.

Eligibility criteria:
inclusion criteria: * patients presenting asymptomatic impacted lower third molar tooth in the vertical or mesioanguler position according to the winter classification, class i and ii ramus relation and class b and c depth according to pell-gregory classification * patients between the ages of 18-30, * non-smokers, * patients with asa i status exclusion criteria: * who does not want to be volunteer for the study, * do not comply with post-operative recommendations, * operation lasting more than 30 minutes, * during pregnancy or lactation, * have a chronic systemic disorder that may affect healing. * unable to cooperate, * post-operative infection, * patients with pericoronitis
effect of l-arginine and pycnogenol on light to moderate hypertension and endothelial function

Conditions: Endothelial Dysfunction; Hyperhomocysteinemia; Hypertension Grade I, Subgroup "Borderline" (WHO)

Summary: the effect of a combination product (verum ) with l-arginine, pycnogenol, vitamin k2, r-(+)-alpha-lipoic acid and vitamins b6, b12 and folic acid is investigated in a double blind placebo-controlled cross-over study. volunteers with hypertension and hyperhomocysteinemia are randomly assigned to the dietary supplement or placebo.

25 patients were included in the trial. intervention period was 4 weeks with 2 months wash out phase. the screening visit of all volunteers before study start included volunteer information, signature of informed consent, anamnesis, medical history, ecg and blood routine analysis. efficacy parameters were measured at visit 1, 2, 3, and 4. endothelial function and postprandial endothelial reaction was tested using endopat (validated diagnosis tool). blood pressure was measured by volunteers over a period of 7 days before each visit. as additional parameters homocysteine and adma (assymmetric dimethyl arginine) were determed. for safety evaluation aes (adverse events), cc (compliance control), tolerability, blood routine parameters and vital signs were assessed.

Eligibility criteria:
inclusion criteria: * borderline blood pressure (systolic 130-149) * homocystein level \>10µmol/l exclusion criteria: e.g. * bmi \ 32kg/m2 * use of antihypertensives, anticoagulants, and statins * cardiovascular diseases e.g. stroke, myocardial infarction * use of l-arginine and other dietary supplements

Keywords: l-arginine pycnogenol vitamin k2 vitamin b endothelial function hypertension homocystein >10
a one year open label study for the treatment of hypogonadism (low testosterone) in men who have completed za-203

Conditions: Hypogonadism; Low Testosterone

Summary: the purpose of this study is to determine the continued effects of androxal on morning testosterone and reproductive status in men with secondary hypogonadism who have completed protocol za-203. men will be allowed to choose androxal (enclomiphene citrate) or testim (topical testosterone) at the beginning of the study. all men on androxal will start at 12.5 mg and will be allowed to up titrate to 25 mg if an inadequate response is exhibited at the lower dose.


Eligibility criteria:
inclusion criteria: * successful completion of za-203 * ability to understand and provide written informed consent * agreement to use a condom, and with a fertile female partner, another form of contraception * agreement to provide semen samples in the clinic exclusion criteria: * any condition which, in the opinion of the investigator, would make the subject an unsuitable candidate for enrollment in the study

Keywords: hypogonadism low testosterone low t
efficacy and safety comparison of tiotropium inhalation solution (respimat inhaler) and spiriva handihaler in chronic obstructive pulmonary disease (copd)

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: comparison of lung function response between tiotropium inhalation solution and spiriva handihaler.


Eligibility criteria:
inclusion criteria: * diagnosis of copd * fev1 \< 60% predicted * fev1 \< 70% of fvc * smoking history of 10 pack-years exclusion criteria: * significant other disease than copd * recent history of mi (1 year or less) * cardiac arrhythmia requiring drug therapy * history of asthma, allergic rhinitis or eosinophil count \> 600 mm3 * symptomatic prostatic hypertrophy or bladder neck obstruction * known narrow-angle glaucoma * abnormal baseline hematology, blood chemistry or urinalysis * history of cancer within last 5 years * life-threatening pulmonary obstruction * cystic fibrosis or bronchiectasis * tuberculosis * pulmonary resection
skamo-2: the real-life test of continuous photoacoustic signal by neogly in patients with type i diabetes

Conditions: Diabetes

Summary: diabetes is one of the very common and chronic diseases in the present world, which affects children and adults. diabetes is characterized by hyperglycemia. hence, diabetic patients need to precisely monitor their blood sugar level regularly a few times a day. currently, the solutions for self-monitoring blood glucose are invasive (finger prick method, continuous glucose monitoring (cgm) using microneedle).the fully non-invasive cgm approaches still are in high demand. the medical device is developed, ultimately, to continuously measure the blood glucose level from continuous in-vivo photoacoustic signal. for this study, the goal is to check if the signal collected by the investigational device is relevant and exploitable in patients with type i diabetes. the main task of participants is to wear the investigational device during one week.


Eligibility criteria:
inclusion criteria: * patients with type i diabetes * male and female patients aged 18 to 50 years * wearing a freestyle libre cgm and giving the access of collected data * using insulin pump or insulin pen and giving the access of collected data * willing to wear the investigational device continuously throughout the study (24h/24h) * affiliated with french social security * having signed the informed consent form exclusion criteria: * any skin disease (inflammatory diseases of skin, cancer of skin, infectious diseases of skin, change in skin color...) * any serious disease that could interfere with the study * body mass index (bmi) \> 30kg/m2 * scars or tattoos on the upper side of the wrist wearing the investigational device * who may have an allergy to one of the material used in the device * who have magnetic resonance imagery (mri), computed tomography (ct) scan or high frequency electrical heat (diathermy) treatment during the study * persons mentioned in articles l1121-5 to l1121-9 of the public health code (pregnancy or lactation ; females with childbearing potential, defined as a premenopausal female and not using an effective form of birth control\*; person deprived of liberty by judicial order ; person under guardianship or curatorship ; minors ; adults who are incapable or unable to give their consent ; cross-over situations) * who would receive more than 4500 euros in compensation due to his or her participation in other research involving the human person in the 12 months preceding this study * who, in the judgment of the investigator, are likely to be non-compliant or uncooperative during the study, or unable to cooperate because of language problem, poor mental development
safety and efficacy of the journey ii bcs total knee system

Conditions: Osteoarthritis, Knee

Summary: assess the safety and efficacy of the journey ii bcs total knee system in subjects with degenerative knee disease requiring primary total knee replacement.

assess the safety and efficacy of the journey ii bcs total knee system in subjects with degenerative knee disease requiring primary total knee replacement. pre-operative and operative assessments collected retrospectively. all postoperative assessments beginning at the 6 month post-operative time point collected prospectively.

Eligibility criteria:
inclusion criteria: * subject received primary total knee arthroplasty with the journey™ ii bcs total knee system due to degenerative joint disease * subject is willing to sign and date an irb approved consent form * subject is of legal age to consent * subject plans to be available through ten (10) years postoperative follow-up * subject agrees to follow the study protocol exclusion criteria: * subject received the journey™ ii bcs total knee system on the affected knee as a revision for a previously failed total or unicondylar knee arthroplasty * subject received tka on the contralateral knee as a revision for a previously failed total or unicondylar knee arthroplasty * subject possesses a contralateral or ipsilateral revision hip arthroplasty * subject has ipsilateral hip arthritis resulting in flexion contracture * at the time of enrollment, subject has one or more of the following arthroplasties that are not fully healed and well-functioning, as determined by the investigator: * ipsilateral or contralateral primary total hip arthroplasty or hip resurfacing arthroplasty * contralateral primary total knee or unicondylar knee arthroplasty * at the time of surgery, subject had an active infection or sepsis (treated or untreated) * at the time of surgery, subject had presence of malignant tumor, metastatic, or neoplastic disease * at the time of surgery, subject had conditions that may interfere with the tka survival or outcome (i.e., paget's or charcot's disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease) * at the time of surgery, subject had contralateral lower extremity condition causing abnormal ambulation * subject is pregnant or plans to become pregnant during the study * subject has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study * at the time of surgery, subject had a bmi\>40 * at the time of enrollment, subject has a bmi\>40 * subject is enrolled in another investigational drug, biologic, or device study * subject is facing current or impending incarceration

Keywords: osteoarthritis degenerative knee disease total knee arthroplasty (tka)