Kornimate/medical-research-clean huggingface dataset:
safety and efficacy of bhv-3000 (rimegepant) orally disintegrating tablet for the acute treatment of chronic rhinosinusitis

Conditions: Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps

Summary: the purpose of this study is to compare the efficacy and safety of rimegepant versus placebo in the acute treatment of chronic rhinosinusitis (crs) with and without nasal polyps.


Eligibility criteria:
inclusion criteria: * at least two episodes of facial pain/pressure/fullness of moderate or severe intensity on a 4-point rating scale (0 = none, 1 = mild, 2 = moderate, 3 = severe) in the past 30 days prior to the screening visit. * subject agrees to study-required medication restrictions and the restriction of not starting new medication to treat crs symptoms during the course of the study. * subject agrees to study-required birth control methods during the course of the study, and female subjects must not be breastfeeding. * no clinically significant abnormality identified on the medical or laboratory evaluation. exclusion criteria: * subject has primary headache disorder. * subject has history of nasal or facial surgery within the 6 months prior to screening. * subject has ongoing rhinitis medicamentosa. * subject has diagnosed or suspected invasive fungal rhinosinusitis. * subject is currently receiving aspirin desensitization or maintenance therapy for samter's triad. * subject has a history of recurrent acute sinusitis (four or more episodes per year of acute bacterial rhinosinusitis (abrs) without signs or symptoms of rhinosinusitis between episodes). * body mass index \> 35.0kg/m2 * subject history of exclusionary medical conditions such as hiv disease, cardiovascular conditions, uncontrolled hypertension or diabetes, psychiatric conditions, drug or alcohol abuse, malignancies, drug allergies, or any significant and/or unstable medical conditions. * subjects taking/using excluded therapies. * participation in clinical trial with non-biological investigational agents or investigational interventional treatments. * subjects who have previously participated in any bhv-3000/ bms-927711/ rimegepant study. * planned participation in any other investigational clinical trial while participating in this clinical trial.

Keywords: chronic rhinosinusitis (crs) chronic rhinosinusitis (crs) with nasal polyps chronic rhinosinusitis (crs) without nasal polyps
pilot study of fructose for sickle cell crisis

Conditions: Sickle Cell Anemia

Summary: objectives: i. evaluate the efficacy and tolerability of fructose administered every 6 hours for up to 72 hours to patients in active sickle cell crisis. ii. obtain tolerability information in selected patients treated with fructose for more than 72 hours.

protocol outline: in the first part of the study, patients are block-randomized (3:1) to a single intravenous dose of fructose or placebo. the dose of fructose is escalated in each successive group after tolerability data are evaluated. in the second part of the study, patients are randomly assigned (1:1) to fructose or placebo administered intravenously every 6 hours for 72 hours. the dose of fructose is the highest well-tolerated dose determined in study 1 or the most tolerated dose for the patient. patients who just completed study 1 may participate if they are clearly in a separate crisis and continue to meet entry criteria. patients whose symptoms persist for more than 72 hours after fructose or placebo are eligible to receive additional fructose every 6 hours until symptoms subside.

Eligibility criteria:
protocol entry criteria: --disease characteristics-- sickle cell crisis requiring hospital admission crisis began at least 12 hours prior to admission medical records documenting sickle cell disease and previous crisis requiring hospital visit during the last 24 months available at study site no thalassemia no complex hemoglobinopathy involving thalassemia and sickle cell disease --patient characteristics-- renal: creatine no greater than 2.2 mg/dl no requirement for regular dialysis other: weight above or below 30% of ideal body weight no fructose intolerance no insulin-dependent diabetes no hiv seropositivity no acquired immune deficiency syndrome (aids) or aids-related illness no general anesthetic for 7 days prior to and 2 days following entry primary language allows communication with study staff demonstration of ability to read and understand pain scales required ability to identify crisis starting time accurately, i.e., to within 6 hours

Keywords: disease-related problem/condition genetic diseases and dysmorphic syndromes hematologic disorders pain rare disease sickle cell anemia
valacyclovir augmentation for cognitive and functional remediation in schizophrenia

Conditions: Herpes Simplex; Schizophrenia; Schizoaffective Disorder

Summary: the effects of valacyclovir (vav) augmentation or placebo (pla) as adjuncts to conventional antipsychotic drug treatment will be evaluated among patients with schizophrenia who have been exposed to herpes simplex virus type 1 (hsv-1). hypothesis: valacyclovir (vav) augmentation improves (a) cognitive and (b) overall function among herpes simples virus 1 (hsv-1) exposed early course schizophrenia patients.

design: we propose a randomized double blind placebo controlled study of patients with early course schizophrenia (sz) / schizoaffective disorder (sza) patients exposed to hsv-1, who are receiving antipsychotic drugs. the effects of vav augmentation or pla as adjuncts to conventional antipsychotic drug treatment will be evaluated. as outcomes, we will evaluate clinical symptoms, cognitive variables, overall function (including social function) and side effects. the participants will be under the direct care of the indian investigators during the study. ratings will be performed blind by research staff. we will pre-screen for hsv-1 exposure. there will be a 2 week placebo run in phase, 16 week augmentation and 4 week follow up to identify post-treatment side effects.

Eligibility criteria:
inclusion criteria: * written informed consent. * both genders, ages 18-50 years * schizophrenia / schizoaffective disorder (dsm iv). * stable dose of antipsychotic for \> 1 month, continued throughout the study. * score 4 or more on one or more items of the positive and negative syndrome scale. * exposed to hsv-1: serum antibody assays. exclusion criteria: * substance abuse in the past month/dependence past 6 months. * history / current medical /neurological illnesses e.g., epilepsy. * pregnancy. * history of immune disorders, hiv infection, or receiving immune-suppressants. * receiving regular antiviral therapy. * history of hypersensitivity to valacyclovir. * mental retardation as defined in dsm iv.
sorafenib to treat flt3-itd aml

Conditions: Acute Myeloid Leukemia; FLT3-ITD Mutation

Summary: it is a prospective, non-interventional, open-label study, in order to observe the safety and response in flt3-itd mutation positive aml patients who receiving sorafenib as induction, consolidation, salvage, maintenance or alleviative treatment. the duration of the study from june 2014 through may 2019, with the recruitment duration from june 2014 to may 2017. the inclusion criteria is: 1. definitely diagnosed as aml 2. flt3-itd mutation has been confirmed 3. accepting the prescription of sorafenib


Eligibility criteria:
inclusion criteria: * definitely diagnosed as aml * flt3-itd mutation has been confirmed * accepting the prescription of sorafenib exclusion criteria: * can not take drugs orally * can not follow the doctors' advices * other reasons that investigators considered as contra-indications for this study
assessment of the influence of the virtual reality headset on pain and anxiety during oocyte retrieval under local anesthesia

Conditions: Oocyte Retrieval; Local Anaesthesia; Virtual Reality

Summary: medically assisted reproduction provides help to infertile couples, single women and couples of women with a pregnancy project, and to women who wish to preserve their gametes. in the context of in vitro fertilization (ivf), oocyte donation or oocyte preservation, it is necessary to perform an oocyte stimulation, followed by an ovarian puncture in order to retrieve mature oocytes. several types of anesthesia can be used for this procedure: general anesthesia, local anesthesia and spinal anesthesia. the puncture can also be performed under hypnosis, but this practice is difficult to generalize, as it requires specific training. none of these different types of anesthesia has proven to be superior in terms of number and quality of oocytes collected, so the choice is left to the patient. general anesthesia is mostly chosen at rennes, although it exposes to more risks and represents a higher socio-economic cost. improving the comfort of these patients during oocyte retrieval is a priority, especially since they may have to undergo several successive retrievals during their treatment. what if virtual reality could be a way to improve the comfort of these patients? indeed, this technology, which allows activity in an artificial 3-dimensional world, is considered as a non-pharmacological tool for pain management and its use during surgery would also reduce the level of anxiety. in our study, during the oocyte retrieval under local anesthesia, the patients randomized in the experimental group will wear a virtual reality headset diffusing an atmosphere considered as relaxing. the expected results of this work would be a significant decrease in pain during oocyte retrieval under local anesthesia in patients wearing the virtual reality headset, associated with a decrease of anxiety and a significantly higher satisfaction score. the final objective would be to consider this tool as a non-invasive means that could be used in routine in the department of medically assisted reproduction of rennes, but also in other cities. in the longer term, the reduction of pain and anxiety could encourage patients to choose local anesthesia and therefore increase its use. observational, prospective, randomized, open-label, monocentric study.


Eligibility criteria:
inclusion criteria: * female adult (at least 18 years old) * for whom an oocyte retrieval is planned * who has had an anesthesia consultation * who has chosen local anesthesia * who has signed an informed and written consent * affiliated to a social security system. exclusion criteria: * pre-existing dizzying sensations * severe facial wounds * history of epilepsy * adults under legal protection, curatorship or guardianship, adults deprived of liberty

Keywords: oocyte retrieval local anaesthesia virtual reality
assessment of the rosacea prevalence in the general population

Conditions: Rosacea

Summary: multi-centre interventional cross-sectional prevalence study assessment of the rosacea prevalence in the general population.

primary objective: assessment of the prevalence of rosacea in the general population per country using subject questionnaire and dermatologist diagnosis

Eligibility criteria:
part i inclusion criteria: the following subjects will be included in the study: * subjects aged 18 to 65 years old from the general population * subjects who are willing to complete the questionnaires part ii inclusion criteria: the following subjects will be included in part ii of the study: * subjects who screened positive for rosacea during the first part of the study and selected by random method * subjects who gave their informed consent to participate in part ii of the study
comparison of dydrogesterone and micronized progesterone treatments in the treatment of threatened miscarriage.

Conditions: Miscarriage Threatening

Summary: in this study, we aimed to compare the effects of two drugs used for the threated miscarriage on the miscarriage rate.

about 140 pregnant women who applied to our clinic due to the threated miscarriage in the first trimester will be randomly given micronized progesterone to half and dydrogesterone to the other half. after the treatment, the miscarriage rates in the groups will be compared.

Eligibility criteria:
inclusion criteria: * pregnant women with threated miscarriage in the first trimester. exclusion criteria: * - pregnant women with abortus incipiens.
influence of an exercise for trunk stabilization performed in stable and unstable surfaces for chronic low back pain.

Conditions: Low Back Pain

Summary: motor control exercises have demonstrated a good option for recovery from chronic low back pain. the purpose of this study is investigated the effectiveness of an exercise program for trunk stabilization performed in stable and unstable surfaces for people with nonspecific chronic low back pain (nclbp). patients will be randomly divided into 3 groups; control group will receive placebo treatment with shortwave; stable group will receive an exercise protocol to stabilize the trunk on a stable surface and unstable group will receive the same exercise protocol but performed on an unstable surface. we hypothesized the unstable group will present pain reduction and functional improvement.


Eligibility criteria:
inclusion criteria: * non-specific low back pain * sedentary * previous low back pain last 6 months exclusion criteria: * traumatic, inflammatory, infectious or tumours etiology * positive neurological findings (leg pain) * pregnancy * previous spine or lower limb surgery * contraindicated for short-waves aplication
non-standardized vs. standardized screening for dysphagia

Conditions: Dysphagia

Summary: the purpose of this study is to compare two different screening tests for detecting dysphagia (difficulty swallowing) as well as the risk for aspiration (silent swallowing of liquids/solids into the lungs) in patients after an ischemic stroke (when a blood clot blocks or narrows an artery leading to the brain).


Eligibility criteria:
inclusion criteria: * adults ≥ 18 years old * patients admitted to lynn rehabilitation center with an admitting diagnosis consistent with acute ischemic stroke within the past 1 month * patients able to provide informed, written consent. if patients are not cognitively able to give informed consent, then consent will be obtained from patient proxy in person or over the phone * able to read and comprehend verbal instruction in english and/or spanish exclusion criteria: * adults \> 80 years old * pregnant women * prisoners * those with a prior history of dysphagia * those with any diagnoses that include acute intracranial hemorrhage, subdural hematoma, subarachnoid hemorrhage, traumatic brain injury

Keywords: difficulty swallowing
a trial of homeopathic medication traumeel s for the treatment of radiation-induced mucositis

Conditions: Mucositis; Head and Neck Cancer

Summary: the specific aim of this study will be to determine the safety of traumeel s for mucositis in head and neck cancer patients undergoing radiation therapy.

oral mucositis is a debilitating side effect of radiation therapy for head and neck cancer patients. the severe inflammation of the oral cavity can be detrimental to quality of life and cause interruption in vital cancer treatment. despite numerous proposed therapies, an effective agent for oral mucositis has yet to be found. traumeel s, a homeopathic remedy made up of highly diluted botanical extracts and minerals, has shown benefit for mucositis in children undergoing chemotherapy. the objective of this study is to evaluate the safety of traummel s in the prevention and treatment of radiation-induced oral mucositis. the patients will use the medication as a mouthwash during radiation therapy and will be evaluated weekly with physical examination criteria and questionnaires for symptoms and side effects.

Eligibility criteria:
inclusion criteria: * head and neck cancer patients post resection of primary tumor with negative or microscopically positive surgical margins * patients undergoing planned radiation therapy * age 18 to 99 * nonsmokers exclusion criteria: * head and neck cancer patients post resection of primary tumor with grossly positive surgical margins * patients receiving adjuvant chemotherapy * pediatric patients (age \< 18) * pregnant women

Keywords: radiation-induced mucositis head and neck cancer traumeel mucositis radiation oral cancer inflammation of the mouth homeopathic medication
effect of intravenous corticosteroid injections on dysphagia after cervical spine surgery

Conditions: Dysphagia After Anterior Cervical Decompression and Fusion of the Spine

Summary: this is a randomized, double-blind, placebo-controlled study to examine the effect of local intravenous steroids following anterior cervical spine surgery on the development of dysphagia in patients.

the purpose of this randomized, double-blind, placebo-controlled study is to examine the effect of local intravenous steroids following anterior cervical spine surgery on the development of dysphagia in patients. this study aims to investigate if there is a difference in the efficacy of intravenous steroids compared to a placebo of physiological saline for patients undergoing anterior cervical spine surgery. furthermore, this study aims to investigate the correlation between radiographic measurements of soft tissue swelling and the severity of dysphagia for patients. finally, this study aims to examine the impact of intravenous steroids on nausea and radicular pain in patients. secondary outcome measures will include patient focused outcomes questionnaires, pain medication requirements, and fusion rates.

Eligibility criteria:
inclusion criteria: * the subjects included in the study are patients undergoing an anterior cervical spine procedure. exclusion criteria: * patients with greater than asa grade ii will be excluded. patients with non-degenerative conditions, such as trauma, tumors, infection, radiation, and diabetes will be excluded. patients with posterior procedures will be excluded. patients with clinical pre-operative dysphagia, indicated by a score of 3 or higher on the eat-10 questionnaire,19 will also be excluded. patients who are pregnant will be excluded from this study.
lung ultrasound in diagnosis and management of bronchiolitis bronchiolitis

Conditions: Bronchiolitis

Summary: to evaluate the correlation between clinical and ultrasound findings in children presented with signs suggestive of bronchiolitis and to validate an ultrasound score for bronchiolitis that will correlate with specific clinical outcomes.


Eligibility criteria:
inclusion criteria: * children presented with signs suggestive of bronchiolitis exclusion criteria: * other major pathology

Keywords: bronchiolitis
accuracy of 3d slicer software for automatic segmentation versus manual segmentation using commercial software to evaluate impacted and unerupted maxillary canine: an observational study

Conditions: Impacted Canines

Summary: our research question will be, can automatic segmentation of maxillary impacted and unerupted canine using dentalsegmentator tool in 3d silcer software be as accurate as manual segmentation?


Eligibility criteria:
inclusion criteria: age ranges from 8-70y (from 8 to less than15y for unerupted group - from 15 to 70y for impacted group). b. scans clearly showing unerupted and impacted maxillary canines. exclusion criteria: 1. scans with artifacts obscuring the area of interest. 2. scans with fractures or pathological lesions obscuring the area of interest. 3. image blurring due to patient movement during acquisition which could interfere with image interpretation.
value of anorectal manometry before ileo- or sigmoidostomy closure after rectal resection

Conditions: Fecal Incontinence; Quality of Life

Summary: background: high prevalence of fecal incontinence after rectal resection in patients with rectal carcinoma. hypothesis: anorectal manometry done before ileostomy or sigmoidostomy closure can predict fecal incontinence. methods: anorectal manometry before, 1 month and 6 month after closure. anorectal endosonography before and 1 month after closure. prediction of postoperative incontinence by the surgeon (digital sphincter examination). visual analog scales for continence, subjective success of operation, and global well being; wexner and vaizey incontinence score; parks incontinence classification; rockwood fecal incontinence quality of life score; each before, 1 and 6 month after closure.


Eligibility criteria:
inclusion criteria: * all patients planned for ileo- or sigmoidostomy closure after rectal resection for rectal carcinoma exclusion criteria: * preoperative incontinence for solid stool * dementia * pregnancy * latex allergy

Keywords: anorectal manometry
self-selection study of the toothwave toothbrush

Conditions: Gingivitis; Plaque; Calculus; Tooth Discoloration

Summary: this study objective is to test the silk'n toothwave self-selection, by potential end users. additionally, this study will evaluate if contraindicated subjects will self-exclude from use of the device and the ability to understand accurately the labeling content (box and user manual).

the silk'n toothwave device, in its original packaging, along with the user manual will be provided to the patient in a simulated home use environment. the patient labeling will be in the format intended for distribution. all subjects will sign an informed consent before any study activity. five (5) potential end users and additional five (5) contraindicated subjects will be screened for this self-selection study. subjects will be provided with the device in its original packaging and will be evaluated for their ability to decide if they are eligible or they should self-exclude themselves from use of the device based solely on reading the device labeling (box and user manual). once the subjects complete reviewing the labeling materials (box and user manual) they will be requested to perform a labeling comprehension exam for testing the ability to correctly understand the labeling content. the study will not include treatment.

Eligibility criteria:
inclusion criteria: 1. subject is male or female equal to or greater than 18 years of age. 2. subject is a potential candidate for purchasing the silk'n toothwave device. 3. subject is capable of understanding and is willing to sign informed consent. exclusion criteria: 1. current or history of oral cavity cancer or oropharyngeal cancer. 2. pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body. 3. pregnant or nursing. 4. any active condition in the oral cavity at the discretion of the investigator. 5. any surgery in the oral cavity within 3 months prior to treatment, or before complete healing. modified inclusion criteria for contraindicated subjects: 1. subject with or an active implant, such as a pacemaker, incontinence device, insulin pump, etc. 2. subject is pregnant or nursing (lactating).