Kornimate/medical-research-clean huggingface dataset:
evaluation of a combined ridge expansion technique with simultaneous dental implant placement

Conditions: Alveolar Process Atrophy

Summary: patients with long span, narrow edentulous ridge in the posterior mandible underwent piezotomed ridge splitting and osseodensification with simultaneous implant placement.

this study is a single arm clinical trial. patients of both genders, who are indicated for ridge splitting, were recruited from the outpatient clinic, faculty of dentistry, alexandria university. the pico question: "what is the effect of piezotomed ridge splitting and osseodensification on implant placement in narrow posterior mandibular ridges?" ethical approval for the study was obtained from the regional ethical review board of the faculty of dentistry. all patients were informed about the procedure details, and each participant signed a written consent. ridge expansion was accomplished by piezotomed ridge splitting and osseodensification. simultaneous implant placement was done in the same procedure. implant stability was assessed. also, bone width gained and bone density were measured around the dental implants using cone beam computed tomography.

Eligibility criteria:
inclusion criteria: * patients with good oral hygiene * patients with long-span, narrow posterior edentulous mandibular area * age limit range \[25 - 66 years\] * patients who accept to participate in the study * minimum height 10mm from the crest of the ridge till the upper border of inferior alveolar canal * minimum ridge thickness = 3mm at the crestal region * if the patient is diabetic, should be controlled. exclusion criteria: * immunosuppressive/ autoimmune disease patients * patients with osteoporosis * lack of sufficient amount of keratinizing mucosa at the crest of the edentulous saddle * patients with bleeding disorder disease * ridge width less than 3 mm * smokers * patients having periodontal disease * the presence of a pathological lesion in the area of ridge splitting
improving hand motor function after stroke: role of robotics

Conditions: It is Possible That Amadeo Will Guarantee a Greater Clinical Improvement as Compared to an Occupational Therapy Thanks to the Strengthening of Brain Plasticity

Summary: two recent randomized clinical trials reported a significant contribute of amadeo toward the recovery of hand motor function in acute stroke patients in association with physiotherapy and/or occupational therapy. however, no data are available in patients with chronic stroke, and the neurophysiological mechanisms underlying such clinical improvement need to be elucidated. given that robotic devices harness brain plasticity to foster motor function recovery, a deeper understanding of the neurophysiological bases of amadeo training could help clinician to realize patient-tailored rehabilitative training based brain plasticity knowledge. we planned a pilot randomized-controlled observer trial aimed at evaluating the effects of intensive robot-assisted hand therapy compared with intensive occupational therapy in chronic phase after stroke. we estimated that 40 patients per group will be required to demonstrate a greater effect of amadeo as compared to occupational therapy, with an effect size of 0.5. twenty chronic stroke patients (at their first-ever stroke) will be enrolled and randomized into two groups. the experimental group will be provided with amadeo training. the control group will be provided with occupational therapy executed by a trained physiotherapist.


Eligibility criteria:
inclusion criteria: * chronic stroke patients at their first-ever supratentorial stroke exclusion criteria: * presence of severe medical, psychiatric and cognitive abnormalities as to interfere with the treatment. * controindications to the device use.
duloxetine versus placebo in chronic low back pain

Conditions: Back Pain Without Radiation

Summary: the primary purpose of your participation in this study is to help answer the following research question, and not to provide you treatment for your condition--whether duloxetine once daily can help patients with chronic low back pain.


Eligibility criteria:
inclusion criteria: - male/female outpatients 18 years of age with chronic low back pain. exclusion criteria: - you have a serious or unstable disease of the heart or blood vessels, liver, kidney, lungs, or blood-related illness, problems with decreased blood flow to arms and legs (peripheral vascular disease), or other medical conditions, or psychiatric conditions that, in the opinion of the investigator, would affect your participation or be likely to lead to hospitalization during the course of the study. - have acute liver injury (such as hepatitis) or severe cirrhosis. - have had previous exposure to duloxetine. - have a body mass index (bmi) over 40. - have major depressive disorder. - require daily narcotics.
therapy-associated saliva and taste change evaluation (taste) in head & neck cancer patients undergoing radiotherapy

Conditions: Head and Neck Cancer

Summary: one of the main side effects of radiation therapy to the head and neck region is altered taste sensation. this causes significant morbidity and has profound effects on the quality of life (qol) of patients. while radiation-associated toxicities like xerostomia and dysphagia are part of large investigations, data on taste impairment is sparse. the taste study sets out to further our understanding of this common side effect with the goal to prevent radiation-associated taste impairment in future patients. in this prospective, observational multicenter study 150 head and neck cancer patients undergoing radiation therapy will be recruited. participants will undergo repetitive (semi-) objective and subjective assessment of their taste, smell and salivary function at specific time points before, during and after radiotherapy. primary endpoint will be patient-reported taste impairment 12 months post radiation therapy using a standardized quality of life questionnaire (mdasi-hn). secondary endpoints will include taste impairment measured using taste strips at 12 months and 2 years post radiation therapy. differences between subgroups (radiation side, chemotherapy, etc.) and changes over time will be assessed while adjusting for confounding factors (e.g. age, sex, smoking history). based on the aquired data, a normal tissue complication probability model for late radiation-associated taste impairment will be develeoped.


Eligibility criteria:
inclusion criteria: * head and neck cancer patients * referred for radiation therapy with curative intent, both definitive and post-operative * age ≥18 * karnofsky performance index of at least 50% * anticipated mean radiation dose to the taste bud bearing tongue mucosa or at least one of the major salivary glands (parotid, submandibular, and/or sublingual gland) of at the minimum 5 gy exclusion criteria: * pregnancy * pre-existing subjective complete loss of taste before start of radiation therapy * planning ct and radiation therapy with oral stent or spacer * partial or total glossectomy which impairs taste assessments of at least one side of the tongue or impairs contouring of the taste bud bearing tongue mucosa on the planning ct * inability to follow instructions related to study procedures or inability to fill in the questionnaires * inability to provide informed consent

Keywords: head and neck cancer radiotherapy taste impairment dysgeusia xerostomia saliva quality of life
effects of blueberries on symptoms and underlying mechanisms of functional gastrointestinal disorders

Conditions: Functional Gastrointestinal Disorders

Summary: there is extensive pre-clinical evidence for potential health effects of blueberries. these are related, but not exclusively due to their high polyphenol content. this translational, clinical, randomized, cross-over, double-blind, placebo-controlled study will investigate the effects of blueberries in freeze-dried powder form on gastrointestinal and extra-gastrointestinal symptoms and function, as well as specific potential underlying mechanisms, in patients with the overlapping functional gastrointestinal disorders, irritable bowel syndrome and functional dyspepsia.


Eligibility criteria:
inclusion criteria: * fifty-five successive male or female patients with functional gastrointestinal disorders fgid) enrolled from our gastroenterology group practice (ggp) in bern, switzerland, classified as having either irritable bowel syndrome (ibs), functional dyspepsia (fd) or both according to rome 4 criteria (drossman et al 2016; schmulson et al. 2017) * age between 18 and 50 years * body mass index 18.5-29.9 kg/m2 * european / caucasian ethnicity * able to give informed consent in german as documented by signature exclusion criteria: * evidence of clinically significant disease, as assessed by usual clinical practice (history, blood and stool tests, imaging and endoscopy, as clinically required) and by investigator. * colonoscopy, antibiotics or probiotics within 2 weeks before or during the study. * planned dietary modifications (including polyphenol-rich fruit or vegetable smoothies, drinks or diets) or initiation of new treatments during the study period, besides the study interventions. * inability or contraindications to undergo the investigated intervention * inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.
nirs to monitor abdominal tissue oxygen saturation in preterm infants

Conditions: Neonatal Disorder

Summary: the nirs (near infrared spectroscopy) sensor will be applied to the abdomen of the study population. to ensure good skin contact the sensor will be placed underneath the diaper. if that should not provide enough measurement stability, additional fixation will be given by employing aforementioned flexible bandage routinely employed in neonatal care. once good skin contact is ensured, the sensor will measure asto2 (abdominal tissue oxygen saturation) for up to seventy-two hours. the presence of this sensor will not disturb daily clinical activities or medical treatment in any way. should good skin contact be endangered by movements, clinical interactions or such, the sensor will be removed and re-attached to the infants' abdomen as a consequence.


Eligibility criteria:
inclusion criteria: * preterm infants with ga less than 35 0/7 weeks * start of measurement earliest at day of life 2 for preterm infants with ga \>=30 0/7 weeks and day of life 4 otherwise. the measurement will not start after day of life 5 for all ga. * signed informed consent of the legal representative(s) is received after being informed. it is sufficient, if the consent form is signed by one legal representative, which is in majority of cases either the mother or the father. * clinically stable condition. the clinical stability is to be reconfirmed before the start and checked during the measurement. exclusion criteria: * injured, hypersensitive or bruised skin present on the belly, * existence of clinical instability at any time during the investigation leads to exclusion, if ordered so by the physician entrusted with the investigation, * any medical care equipment, e.g. patches, dressing, umbilical arterial or venous catheter, blood supply, etc., prohibiting correct placement of the sensors, * dark skin pigmentation or dense hairiness on the belly absorbing too much light in the near infrared region to allow for nirs, * congenital malformations, * severe metabolic disorders, * early onset sepsis, * inability of legal representatives to understand the purpose of the clinical trial due to language barriers such as the insufficient ability to understand the spoken or written language, * the treatment of newborn jaundice with light during the intended measurement time, * previous enrolment into the current study, * family members, employees and other dependent persons of the investigator, * participation in another study with investigational drug/device within the preceding days and during the present study which may influence asto2.
e-health psychosocial stress and symptom management (epsmi) for pancreatic cancer patients

Conditions: Pancreatic Cancer

Summary: the purpose of this research is to evaluate a new, web-based program among patients with pancreatic cancer aimed at reducing psychosocial stress.


Eligibility criteria:
inclusion criteria: 1. greater than 18 years of age. 2. spanish or english speaker with ability to read one of these languages. 3. diagnosis of pancreatic cancer. 4. patients diagnosed with pancreatic neuroendocrine tumor (pnet). exclusion criteria: 1. patients unable to read spanish or english, as participants will not be unable to complete surveys. 2. have a history of severe psychiatric illness (e.g., psychosis, active suicidality, inpatient treatment in the past 12 months). 3. have any condition that, in the opinion of the investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements.
the impact of antibiotics mic value on the efficacy of treatment regimens for helicobacter pylori infection.

Conditions: Helicobacter Pylori Infection

Summary: clarithromycin (cla)、amoxicillin (amo)、metronidazole (met)、levofloxacin (lev) and tetracycline (tet) are commonly used antibiotics for helicobacter pylori (hp) therapy. however, the efficacy of treatment for helicobacter pylori infection has decreased due to increasing resistance to cla, met and lev. studies had reported that beside antibiotics resistance, other factors such as age, sex, underlying disease, etc. may also affect the treatment efficacy. in some cases, when the mic values were beyond the breakpoint, h. pylori strains with lower mic value had better eradication than the ones with higher mic value. however, few study investigated the relationship between mic values and treatment outcome. the investigators aimed to analyze the impact of influencing factors, especially minimal inhibitory concentration (mic) value, on the efficacy of different treatment regimens.


Eligibility criteria:
inclusion criteria: * patients (aged ≥ 20 years old) with h. pylori infection between jan. 1994 to mar. 2018 exclusion criteria: * without antibiotics susceptible test result, without treatment outcome, history of any gastrointestinal surgery, serious concomitant (renal failure, liver cirrhosis, heart failure and disease need immunosuppressant for therapy.

Keywords: helicobacter pylori resistance minimal inhibitory concentration treatment efficacy
rhythmic auditory stimulation & gait training

Conditions: Multiple Sclerosis; Gait Disorders, Neurologic

Summary: this study will enroll patients with multiple sclerosis and some difficulty with walking. the purpose of this study is to use rhythmic auditory stimulation (ras) a music therapy technique that provides rhythmic auditory cues (like a beat) to help improve a patient's movements, especially when walking. participants will be asked to participate in a walking program (wp) with rhythmic auditory stimulation (ras), or a wp without ras.

rhythmic auditory stimulation (ras) is a music therapy technique that provides rhythmic auditory cues (like a beat) to help improve patients' movements, especially when walking. the ras can be delivered at a fixed tempo or interactive tempo. the device used in this study will deliver an interactive tempo. the equipment will include a mobile device app and sensors that are attached to the participant's shoes. headphones and smartphones will be required to use the device and will be provided to the study team and kept at the center for this study. the device is designed to use audio cues to facilitate improvements in the participant's walking speed while listening to music. the overall purpose of this study is to assess the safety and acceptability of interactive ras music combined with gait training in individuals with ms and walking impairment, and to gather preliminary efficacy data for future studies.

Eligibility criteria:
inclusion criteria: * diagnosis of ms based on 2017 revised mcdonald criteria (relapsing or progressive course) * performs the t25fw in 8 to 30 seconds (cane(s), walking stick(s), crutch(es), or wheeled walker allowed) exclusion criteria: * physical therapy in the past 3 months or immediate need for pt due to safety concerns (e.g. falls) * requires at least one seated rest during the 6 mw test * treatment with high-dose corticosteroids in the past 2 months or planned during the study period * lower extremity botulinum toxin (bt) injections for spasticity in the past 3 months, or planned during the study period * initiation of an oral symptomatic therapy which could affect walking in the past 4 weeks (particularly dalfampridine and medications for spasticity) * initiation of a new disease-modifying therapy for ms in the past 3 months * comorbidity compromising safe participation or affecting walking (e.g. uncontrolled cardiac or respiratory illness, musculoskeletal disorder) * severe hearing impairment with or without the use of hearing aids, such that the participant cannot hear the rhythmic music stimulus consistently. inability to walk safely to the rhythmic music stimulus during the baseline visit.

Keywords: gait analysis music therapy multiple sclerosis
clinical study to evaluate the pharmacokinetics, safety, tolerability and pharmacodynamic effects of a single oral 10 mg bay1101042 tablet dose in men and woman with renal impairment and in healthy subjects

Conditions: Renal Impairment

Summary: to investigate the pharmacokinetics of bay1101042 in subjects with mild to severe renal impairment, stratified according to estimated glomerular filtration rate (egfr) determined 2-10 days prior to dosing, and age-, weight- and gender- matched healthy subjects and to assess the safety, tolerability, and pharmacodynamics of bay1101042 after a single oral dose of a 10 mg bay1101042 given as 5 mg modified release (mr) tablet.


Eligibility criteria:
inclusion criteria: * ability to understand and follow study-related instructions and ability to participate in the study for the entire period. * age: 18 to 79 years (inclusive) at the screening visit. * body mass index (bmi): 18 to 34 kg/m² (both inclusive). * male or female subject. * only women without childbearing potential will be included in the study (e.g. postmenopausal for at least one year, women with bilateral ovariectomy and women with hysterectomy). subjects with renal impairment: * egfr \<90 ml/min/1.73 m\*2 determined from serum creatinine 2-10 days prior to dosing. * stable renal disease, i.e. a serum creatinine value determined at least 3 months before the pre-study visit (e.g. during routine diagnostics) should not vary by more than 20% from the serum creatinine value determined at the pre-study visit. healthy subjects: - egfr ≥90 ml/min/1.73 m\*2 determined from serum creatinine 2-10 days prior to dosing. exclusion criteria: * pregnant or lactating women. * medical disorder, condition or history of such that would impair the subject's ability to participate or complete this study in the opinion of the investigator.
fluoride-labeled boronophenylalanine pet imaging in patients with solid tumors

Conditions: Solid Tumor, Adult

Summary: recently, new high-dose radiation therapy \[e.g., boron neutron capture therapy (bnct)\] absorbed into the tumor tissue has been applied to treat patients with solid tumors. here we examine and describe how to evaluate the biological activity of tumors using positron emission tomography (pet) with fluoride-labeled boronophenylalanine (f-bpa) as a tracer.

boron neutron capture therapy（bnct） is an advanced cell-scale binary targeted radiotherapy technology that combines the advantages of targeted therapy and heavy ion therapy. bnct provides a neutron source from a reactor or a medical accelerator. at the same time, the patient needs to be pre-injected with a boron-containing drug containing a non-radioactive boron 10 isotope. the boron drug enters the body and accumulates specifically in cancer cells. the patient receives epithermal neutron beam irradiation with high linear energy transfer (linear energytransferlet), thereby achieving the effect of killing tumor cells. purpose，bnct has more advantages over conventional radiotherapy, and normal tissue is better preserved than conventional radiotherapy. pet imaging is a useful and effective technique to give absolute quantitative and biological distribution data of bpa in a non-invasive manner, and can add important characteristic parameters such as t/n ratio, suv and kinetic parameters. given the complexity of bnct, pet and pet/ct is currently the new standard for designing patient recruitment: the methodology of l-18f-bpa pet is an important tool to design clinical trials , estimate the size of tumor and indicate the concentration ratio of bpa in surrounding normal tissues. following this principle, researchers can accurately identify which patients can benefit from bnct treatment through the selective accumulation of bpa in individual tumors. pet scans can provide a three-dimensional map of the boron distribution, which can be used for macroscopic dose calculations in the bnct conventional neutron transmission code. because most of the dose absorbed by living cells (65%) comes from the 10b(n,a)7li response, the distribution of boron determines the variability of the main absorbed dose in the treatment plan. as a result, therapeutic schedule will be improved because the boron distribution will greatly affect the isodose line. routine calculations provide a wider range of isodose contours, whereas pet produces contours that more closely approximate the observed clinical results of bnct.

Eligibility criteria:
inclusion criteria: * patients with clinically diagnosed solid tumors, including but not limited to recurrent head and neck cancer, glioma, pancreatic cancer, osteosarcoma, etc.; the selected subjects need to sign the informed consent. exclusion criteria: * pregnant women; renal failure (serum cr\>3mg/dl); patients with claustrophobia;

Keywords: solid tumor bpa-pet
exercise for improving prostate oxygenation in prostate tumors (exipox)

Conditions: Prostate Cancer; Physical Activity; Hypoxia

Summary: previous research into metabolic and hypoxic markers has found evidence of preclinical impact of exercise on prostate tumor blood flow and oxygenation in rodents . as radiotherapy is a frequently used and effective therapy for and that sufficient oxygenation is decisive to the effect of radiotherapy, an underlying hypothesis that aerobic exercise might improve treatment efficacy of radiotherapy in prostate cancer is put forward. this study has a potential challenging intervention, but a potential very high gain as it includes active patient participation to significantly improve outcome of radical radiotherapy.

a randomized controlled trial with four to five weeks of moderate/high intensity aerobic exercise program compared with no intervention for 32 prostate cancer patients waiting for radical prostatectomy at the university hospital of north norway (unn). 16 patients will undergo the intervention. the expression of the hypoxic marker pimonidazole in the prostate specimens of intervention groups and the control groups will be assessed. this method is considered a reliable tissue oxygenation measurement technique. these patients will also have their and blood flow and hypoxia measured in prostate cancers through magnetic resonance imaging (mris).

Eligibility criteria:
inclusion criteria: * diagnosed pc * planned radical prostatectomy * informed consent given * above 18 years of age * bmi \< 30 * non-smoker * living in tromso region exclusion criteria: * contraindications to the intervention like; * heart failure, * angina pectoris, * respiratory disease limiting possible intervention * use of physical supportive devices to aid movement * high level of physical activity * smoking * bmi\>30