Kornimate/medical-research-clean huggingface dataset:
hairstetics hair implant device safety and efficacy

Conditions: Alopecia

Summary: this is a prospective, single-arm, multi-center, international, open-label, non-randomized, clinical study. the aim of the study is to assess the safety and efficacy of the use of the hairstetics hair implant device in subjects affected with hair loss.


Eligibility criteria:
inclusion criteria: 1. subject is ≥ 19 years old. 2. subject has hair loss and has chosen to undergo synthetic hair implantation. 3. subject has mental capacity to understand study guidelines and requirements (to maintain scalp hygiene, use of shampoo, delicate combing, etc.). 4. subject has been evaluated by the investigator to have a scalp condition in the planned area of implantation that is acceptable for entering the study and currently is not suffering from skin problems at planned implantation site or elsewhere that might affect the procedure and/or success as clinically evaluated by the investigator. 5. subject has good general health. 6. woman of child bearing potential must have a negative pregnancy test. 7. subject willing to sign a written informed consent form (icf) and the post implantation maintenance protocol. exclusion criteria: 1. previous synthetic hair implantation or hair transplantation in the past 6 months. 2. currently suffering from skin problems at planned implantation site or elsewhere that might affect the procedure and/or success as clinically evaluated by the investigator. 3. currently receiving or have within the past 3 months received radiation- and/or chemotherapy. 4. currently using steroid product with immunosuppressive treatment. 5. impaired coagulation. 6. serious illness that may affect subject compliance to protocol. 7. subject is using illegal drugs. 8. participating in other clinical study. 9. known allergy or hypersensitivity to nitinol or nickel or titanium 10. for woman: pregnancy or breast feeding. 11. known allergy or intolerance for the prescribed antibiotics and in such a case, a different antibiotics for which the subject is not allergic or intolerance to, will be prescribed
single-dose safety study of apd916 in healthy volunteers

Conditions: Narcolepsy With or Without Cataplexy

Summary: the apd916-001 study is designed primarily to evaluate the safety and tolerability of apd916 when administered as a single dose

this is a phase 1, randomized, double-blind, placebo-controlled, single-dose escalation study of up to 9 dose cohorts (1, 2, 5, 10, 20, 30, 45, 70 and 90 mg) each comprising 8 subjects (2 to receive placebo, 6 to receive apd916). each cohort will be assigned to receive a single dose of apd916. after dosing within the first cohort has been completed and safety data review identifies no tolerability issues, and the principal investigator (pi) and sponsor have agreed that it is safe to proceed, then subjects in the next cohort may be dosed.

Eligibility criteria:
inclusion criteria: * healthy males or females ages 18-45 years * body weight of 50-100 kg (110-220 pounds) * eligible female subjects will be non-pregnant, evidenced by a negative serum pregnancy test at screening and a urine dipstick pregnancy test on day -1 (check-in); non-lactating; surgically sterile, postmenopausal, or agree to continue to use a medically accepted method of birth control during and for at least 1 month after last study medication administration. * eligible male subjects will either be surgically sterile (i.e., vasectomy), for at least 3 months prior to screening, or agree to use a condom with spermicide when sexually active with a female partner who is not using an acceptable method of birth control during the study and for 1 month after. exclusion criteria * subject who has donated any blood, or had significant blood loss within 56 days of dosing * history of smoking or tobacco use within 3 months prior to dosing * history of epilepsy or other seizure disorder * recent history (within 2 years prior to the screening visit) of sleep disorders * history (within 2 years prior to the screening visit) of add or adhd * traveled across more than 3 time zones within 2 weeks prior to dosing
nhf vs. cot in hypoxemic pandemic viral illness

Conditions: Acute Viral Bronchitis; Hypoxemic Respiratory Failure; Hypercapnic Respiratory Failure

Summary: the study compares oxygen and nhf in patients with acute viral illness. the duration will be 72h. after them physiological parameters and the outcome will be evaluated.


Eligibility criteria:
inclusion criteria: * acute hyperemic viral illness * acute hyperemic or hypercapnia respiratory failure exclusion criteria: * intubation criteria * indication for niv therapy * influences of primary endpoint (rip fracture, lung embolism) * tracheostomy * other interventional trials * noncompliance
glu298asp polymorphism and blood pressure

Conditions: Hypertension

Summary: the glu298asp polymorphism has been linked to increased risk of cardiovascular events, proposed to be due to reduced nitric oxide production by enos reported in some but not all studies. we hypothesise that beetroot-enriched bread interacts with the glu298asp polymorphism of the enos gene to lower blood pressure and increase plasma nitrate/nitrite, particularly in carriers of the t allele, which have been associated with lower enos activity and increased risk of hypertension.


Eligibility criteria:
inclusion criteria: * male * a signed consent form * age 18-64 years * body mass index - 18.5-30 kg/m2 * non-smoking, healthy individuals * normal blood pressure at screening (\< 150/90) exclusion criteria: * subjects with anaemia * sufferers of chronic illnesses * individuals with food allergies * people with diabetes * people with coeliac disease * women * vegetarians

Keywords: glu298asp polymorphism blood pressure plasma nox beetroot
the mcrc patients with pmmr/mss or dmmr/msi-h status received palliative chemotherapy efficacy and survival

Conditions: Colorectal Cancer Metastatic; Mismatch Repair Deficiency; Microsatellite Instability High

Summary: deficient mismatch repair (dmmr) or microsatellite instability high (msi-h) accounts for 4-5% in metastatic colorectal cancer (mcrc). the efficacy and survival of patients with dmmr/msi-h status received palliative chemotherapy have not clear yet. in this study, the investigators observed the efficacy and survival of dmmr/msi-h status mcrc patients received palliative first-line chemotherapy.

colorectal cancer (crc) is the one of most common cancer in the world. loss of function of dna mismatch repair (mmr) is an important mechanism of crc development. mutation or modification of mmr genes result in mmr protein deficient (dmmr) and microsatellite instability (msi). it has been reported that the dmmr or msi high (msi-h) phenotype is present in approximately 15-18% of crc patients. most dmmr/msi-h tumors are sporadic crc, and only approximately 3% of dmmr/msi-h tumors are lynch syndrome (ls) or hereditary nonpolyposis colorectal carcinoma (hnpcc). the dmmr/msi-h status was reported to be a predictive marker for adjuvant chemotherapy. multiple retrospective studies showed that dmmr/msi-h is correlated with a favorable prognosis in stage ii/iii crc. previous studies suggested that dmmr/msi status may be a predictive marker of decreased benefit form adjuvant monotherapy of 5-fluorouracil (5-fu) in patients with stage ii disease, but not in those with stage iii disease. for metastatic colorectal cancer (mcrc), the relationship of the mmr/msi phenotype and prognosis is unclear. some researchers found that crc patients with the dmmr/msi-h phenotype have a worse prognosis. but other researchers thought the dmmr/msi-h phenotype is no associate to efficacy and survival of palliative chemotherapy, even is benefit for efficacy and survival.therefore, the aim of this study was to clarify whether the status of dmmr/msi-h affected progression-free survival (pfs) in mcrc patients who received first-line palliative chemotherapy.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years old 2. histologically confirmed metastatic colorectal adenocarcinoma; 3. immunohistochemistry confirmed mismatch repair status or polymerase chain reaction (pcr) / next-generation sequencing (ngs) confirmed microsatellite status 4. received palliative chemotherapy and have complete information of treatment exclusion criteria: 1. patients have not tested for mismatch repair or microsatellite 2. patients have not received palliative chemotherapy or received palliative chemotherapy but treatment information incomplete

Keywords: colorectal cancer metastatic mismatch repair deficiency microsatellite instability high chemotherapy
the effect of esomeprazole and fundoplication on airways

Conditions: Airway Responsiveness

Summary: evaluate the prevalence of bronchial responsiveness (bhr) among patients with gastroesophageal reflux disease (gerd). investigate correlation between bronchial reactivity and the severity of gerd, and similarly investigate the correlation between exhaled nitric oxide (no) and the severity of gerd. compare the effects of esomeprazole 40 mg twice daily and nissen fundoplication on bronchial reactivity, exhaled no, pulmonary function and quality of life.


Eligibility criteria:
inclusion criteria: 1. over 18 of age 2. diagnosis of gastroesophageal reflux disease 3. compliance to perform methacholine inhalation challenge (judged by the investigator) exclusion criteria: 1. known allergy to esomeprazole or any other ppi 2. use of systemic corticosteroids within 3 weeks before any study visit 3. pregnancy (in a written informed consent patients are asked to assure that they are not pregnant and they are also told to immediately stop the study medication if they become pregnant during the study) 4. incapability to keep a 3-week washout with usual antireflux medication prior to the first visit 5. regular use of ppi or h2-ra medication 3 months after fundoplication
sleep apnea screening using mobile ambulatory recorders after tia/stroke

Conditions: Stroke; Transient Ischemic Attack; Obstructive Sleep Apnea

Summary: obstructive sleep apnea (osa) is common after stroke/tia and, left untreated, is associated with recurrent vascular events, poor functional outcomes, and long-term mortality. despite its high prevalence, osa often remains underdiagnosed after stroke. the purpose of this study is to evaluate portable sleep monitors (psms) as a broad screening tool for osa after stroke/tia. the study investigators hypothesize that the screening with psms will lead to an increase in the diagnosis of treatable osa after stroke/tia and an improvement in sleep-related and functional outcomes.

obstructive sleep apnea (osa) is common after stroke and, left untreated, is associated with recurrent vascular events, poor functional outcomes, and long-term mortality. despite its high prevalence, osa often remains underdiagnosed after stroke. while in-laboratory polysomnography studies are the gold standard for diagnosing osa, their use is limited by the lack of availability, patient unwillingness to sleep overnight at a laboratory and high costs. home-based psms can accurately diagnose osa and are much more accessible, convenient and low-priced compared to in-laboratory sleep studies. the primary purpose of this study is to determine whether broad screening for osa using psms, as compared to usual care, increases the proportion of patients diagnosed with treatable osa after stroke or tia. secondary aims include whether screening with psms increases the proportion of patients treated for osa with continuous positive airway pressure (cpap) and whether functional outcomes and sleep-related outcomes are improved. finally, the study will also determine whether this approach is cost-effective.

Eligibility criteria:
inclusion criteria: * imaging-confirmed stroke or stroke-neurologist diagnosed tia in the past 6-months, and * outpatients being managed at the sunnybrook stroke prevention clinic or inpatients on the sunnybrook stroke unit. exclusion criteria: * prior diagnosis of osa * current use of cpap * life expectancy less than 12 months * the presence of conditions known to compromise the accuracy of portable sleep monitoring, such as moderate to severe pulmonary disease or congestive heart failure * oxygen therapy (eg. nasal prongs), a nasogastric tube, or other medical devices that would interfere with the placement of the sensors of the sleep monitoring device and/or cpap * physical impairment, aphasia, or language barrier restricting ability to complete study assessments, overnight sleep monitoring, and/or comply with cpap therapy, and no caregiver available to assist the patient with the study requirements * facial or bulbar weakness or trauma restricting the ability to create a seal with a cpap mask * pregnancy * occupation that would make randomization to the standard of care arm unethical * not covered by ontario health insurance plan (ohip) * unable to attend follow-up assessments

Keywords: stroke transient ischemic attack obstructive sleep apnea portable sleep monitor screening
flavonols and endothelial injury

Conditions: Endothelial Dysfunction

Summary: with increasing age, arterial endothelial cell function is impaired, which is associated with decreased regeneration response and increased intimal hyperplasia after endothelial injury. dietary flavanols can reduce endothelial dysfunction acutely and chronically, but the exact mechanism is unknown. recent studies suggest that flavanols may affect important endothelial regeneration response processes and possibly mediate long-term positive vascular effects. the aim of this study is to investigate age-dependent mechanisms of impaired endothelial regeneration and the influence of dietary flavanols on them. for this purpose, younger and old male patients, who are clinically indicated for elective transradial catheterization, will get periinterventional a test drink , which is rich on flavonols (800 mg flavanols daily), or control drink. administration of drinks is randomized and double-blind. the test drinks should be given one week before the elective catheter examination until 1 week later. the endothelial regeneration is to be investigated as endothelium-dependent vasodilation non-invasively in the area of the puncture site on the forearm and by means of biomarkers in the blood. the endothelial function of the arteria radialis will be measured with flow mediated dilation (fmd) before and 24 h after catheterization. one month after catheterization patients undergo ultrasound examination of arteria radialis, to include structural vessel wall changes as intimal media thickness.


Eligibility criteria:
inclusion criteria: * planed catheterization, that has be done via arteria radialis exclusion criteria: * acute infection (crp\>0.5 mg/dl) * malignant diseases * heart failure (nyha iii-iv) * renal failure (gfr\<60 ml/min) * profoundly atrial fibrilation * hypotension (≤100/60 mmhg) * intolerance of nitroglycerin

Keywords: endothelial function flavonols intima injury
dietary modification intervention involving family support (famnutri) for managing sarcopenic obesity among community-dwelling older adults

Conditions: Sarcopenic Obesity

Summary: the goal of this pilot rct is to examine the feasibility and preliminary effects of a dietary modification intervention involving family support (famnutri) on the management of sarcopenic obesity among older people living in the community. the main questions it aims to answer are: 1. is the intervention feasible and acceptable for community-dwelling older people with sarcopenic obesity? 2. what are the preliminary effects of the intervention on managing sarcopenic obesity in this population? researchers will compare the famnutri group, the nutri group, and a passive control group to see if the dietary modification intervention with family support has additional benefits over the dietary modification intervention alone and no intervention. participants will: attend 6 face-to-face one-hour bi-weekly sessions over 15 weeks receive bi-weekly phone calls to foster adherence to the hypocaloric diet with high protein intake (for the famnutri group) invite a family member to attend the sessions together


Eligibility criteria:
inclusion criteria: 1. older adults aged 65 years old or above who are living in the community and have not less than 4 shared meals with family weekly 2. having a family member consent to offer support to the study participant 3. diagnosed as having sarcopenic obesity using the diagnostic criteria of asian working group for sarcopenia (awgs) for sarcopenia and definition from who for obesity for asian, respectively: 3a)early-stage sarcopenia is defined by meeting one of the following criteria: low handgrip strength \ 30% 4. ability to read, write and understand chinese without severe speaking, hearing and vision problems for intervention delivery. exclusion criteria: 1. having any existing disease or condition that affects digestion or food intake, such as severe heart diseases, renal diseases, depression or advanced stages of cancer 2. having medications that impact dietary patterns, digestion, or metabolism 3. following specific dietary pattern or restrictions, such as diabetic diets and renal diets 4. having alcohol addiction defined by alcohol use disorders identification test (audit) scoring 8 or above since it may affect their ability and their determination to make changes in dietary modification 5. having medical implants such as a pacemaker since the equipment to carry out bioelectric impedance analysis (inbody s10) may cause malfunctioning of the implanted devices.

Keywords: sarcopenic obesity dietary intervention pilot rct
quality control of ce-certified phonak hearing aids - 2015_03

Conditions: Hearing Loss

Summary: phonak hearing systems pass through different development and study stages. at an early stage, feasibility studies are conducted to investigate new algorithms, features and functions in an isolated manner.


Eligibility criteria:
inclusion criteria: * adult hearing impaired persons (minimum age: 18 years) with and without (experience with) hearing aids * good written and spoken (swiss) german language skills * healthy outer ear * ability to fill in a questionnaire (p/ecrf) conscientiously * informed consent as documented by signature exclusion criteria: * contraindications to the md in this study, e.g. known hypersensitivity or allergy to the investigational product * limited mobility and not in the position to attend weekly appointments * limited ability to describe listening impressions/experiences and the use of the hearing aid * inability to produce a reliable hearing test result * massively limited dexterity * known psychological problems * central hearing disorders
communication in breast cancer care

Conditions: Communication; Breast Cancer; Quality of Life

Summary: the investigators will create 4 information-video's about chemotherapy side-effects in curative breast cancer care. the communication is manipulated in the four videos. participants will watch the video before the first chemotherapy and complete questionnaires before and after viewing the video and after chemotherapy 1,2 and 4. (the investigators cannot yet reveal the manipulation as it would influence the participants)

na, the investigators cannot yet reveal the manipulation as it would influence the participants.

Eligibility criteria:
inclusion criteria: * adult (\>18 years old) female breast cancer patients * chemo-naïve patients * scheduled in for curative neo-adjuvant chemotherapy: four courses of ac chemotherapy (all combinations of ac + other chemotherapy courses are eligible) * cognitively able to fill out an online questionnaire * having internet access * sufficient command of the dutch language * pre-chemo no previous treatment or pre-chemo breast-conserving surgery and radiotherapy (wle patients) exclusion criteria: * na

Keywords: scripted video-vignette study
a controlled study of olanzapine in children with autism

Conditions: Autistic Disorder

Summary: this is a 12-week study which investigates the use of olanzapine to decrease disruptive behaviors sometimes associated with autism in children, aged 3 to 12 years old. the first six weeks of the study are double-blind and placebo controlled, meaning that patients receive either placebo or olanzapine, and that neither the researchers nor the patients know whether or not they are receiving placebo or olanzapine. in the second six weeks all of the patients receive olanzapine. the purpose in using placebo is that it is otherwise impossible to know how effective the drug is or whether or not the drug causes side effects. patients treated with placebo can have improvement and can have side effects. in the study patients receive a psychiatric evaluation, physical examination, laboratory tests, and study medication (olanzapine or placebo), free of charge.


Eligibility criteria:
inclusion criteria: 1. males and females, aged between 3 and 12 years. 2. autistic disorder - dsm-iv criteria. 3. a score of at least moderately impaired on the cgi-severity item. 4. clinical judgment that medication treatment for autism is indicated. exclusion criteria: 1. rett's disorder, childhood disintegrative disorder, asperger's disorder, and pdd, nos. 2. psychotic disorder (dsm-iv) (including schizophreniform disorder and schizophrenia). 3. major depressive disorder (dsm-iv). 4. bipolar disorder (dsm-iv). 5. history of psychoactive drug in the previous 2 weeks prior to phase 1. 6. a history of treatment with olanzapine for a cumulative period of greater than 2 weeks prior to entering phase 1. 7. systemic diseases such as cardiac, renal, thyroid diseases, uncontrolled seizure disorder (seizure disorder that is not controlled by anti-epileptic medication - a child who is seizure free for a period of 6 months on a stable dose of antiepileptic drug would be considered controlled), or diabetes mellitus. 8. children with a known medical cause for autistic disorder. 9. abnormal fasting blood glucose or history of diabetes. 10. baseline body mass index (bmi) greater than the 90th percentile for age and gender (cdc growth charts, kuczmarski et al, 2000) (because of risk of weight gain). 11. baseline qtc \>450 msec. note: historically, patients we evaluate do not have qtc values \>450. 12. dyskinesias at baseline (per the criteria of schooler and kane, 1982).

Keywords: autism pervasive developmental disorder treatment olanzapine antipsychotic