Kornimate/medical-research-clean huggingface dataset:
prevention of radiation-induced severe oral mucositis in oral cavity, oropharynx, hypopharynx, and cavum cancer

Conditions: Oropharynx Cancer; Hypopharynx Cancer

Summary: the purpose of this study is to evaluate the benefit of a mouthwash with a phytopharmaceutical preparation, homeodent®, compared to a mouthwash solution containing sodium bicarbonate, for prevention of severe mucositis (grade ≥3, rtog classification) in patients receiving irradiation for oral cavity, oropharynx, hypopharynx or cavum cancer. this is a phase iii, controlled, randomized, single blind study. the estimated inclusion period is approximately 24 months. the number of patients required in this monocentric study is 330 (165 per arm).

the standard treatment of oral cavity, oropharynx, hypopharynx, and cavum cancers is external radiotherapy. however, one of the associated toxicities is the occurrence of mucositis which can be a limiting factor in the treatment (dose reduction or treatment interruption can limit patient's survival), patient's quality of life decreases and severe complications can occur. the treatment of mucositis is mainly symptomatic; a randomized study has shown a benefit of a mouthwash with benzydamine, a non steroidal anti-inflammatory drug, for patients receiving 50-gy radiation. another study with a lower number of patients has also shown a benefit of using a zinc sulfate solution. boiron laboratories have developed a phytopharmaceutical preparation, homeodent®, which has no secondary effects and which could prevent radiation-induced mucositis. this study will evaluate the efficiency of mouthwash with homeodent® in a large randomized trial.

Eligibility criteria:
inclusion criteria: * male or female patient aged ≥ 18 years * ecog ps ≤ 2 * patient with oral cavity and/or oropharynx and/or hypopharynx and/or cavum epidermoid carcinoma, whatever the stage * patient receiving a minimum radiation dose of 60 gy * planned radiotherapy to at least 1/3 of the oral mucosa and/or oropharynx * mandatory affiliation with a health insurance system * signed, written informed consent exclusion criteria: * previous irradiation to the oral mucosa and/or oropharynx * pre-existing mucositis * pregnant or lactating woman (negative serum or urinary pregnancy test for women with child-bearing potential) * patient included in another study including experimental radiotherapy possibly toxic to the mucosa * difficult follow up of the patient * patient deprived of civil rights

Keywords: epidermoid carcinoma hypopharynx oropharynx oral cavity oral mucosa cavum severe oral mucositis radiotherapy phytotherapy
safety study of treatment of leg fractures

Conditions: Tibial Fractures

Summary: this study evaluates the safety of the evos small plating system in patients who have a fracture of the tibia requiring surgery.

this is a multicenter, prospective, post-marketing, observational, case series study to evaluate the safety and efficacy of the evos small plating system in subjects with proximal or distal (pilon or ankle) tibial fractures. subjects will be recruited in the hospital emergency room or surgical department, at the point of identification of the need for orif surgery, and the decision is made to use the evos small plating system. the choice of medical and surgical treatment will be made independently by the investigator in the regular course of practice and will not be influenced by this study protocol. approximately 100 subjects will be enrolled in order to ensure at least 90 evaluable subjects, with a minimum of 45 evaluable subjects having either a) proximal or b) distal tibial fractures. safety monitoring will include documentation device- and surgery-related aes. efficacy will be monitored by assessment of post-operative fracture resolution according to standard radiological practice (x-rays), clinical complications, reoperation rate, dri, eq-5d-5l, and pain vas.

Eligibility criteria:
inclusion criteria: 1. male or female subject who is 18 years of age or older at the time of signing the informed consent. 2. subject provides an institutional review board (irb)-approved informed consent. the subject must have the physical and mental capacity to provide informed consent for him/herself. 3. subject has experienced proximal tibial fracture (ota type 41 a-c) or distal tibial fracture (ota 43 type a-c) with or without fibular/malleolar involvement (ota 44 a-c) and are scheduled for orif using the evos small plating system. 4. subject is willing and able to attend all study visits including 1 year post-operative follow-up. exclusion criteria: 1. subject has contraindications or hypersensitivity to the use of the evos small plating system or its components (316l stainless steel). 2. subject has a physical condition that, in the opinion of the investigator, would preclude adequate implant support or retard healing, such as blood supply impairment, insufficient bone quality or quantity, previous infection, obesity, severe bow or gross bony distortion of the tibia, as detailed in the ifu. 3. subject has, in the opinion of the investigator, an emotional or neurologic condition that precludes cooperation and compliance with the rehabilitation regimen. 4. subject is currently in another investigational drug, biologic, or device study or has been treated with an investigational product within the last 30 days. 5. subject is known to be at risk for loss to follow-up, or failure to return for scheduled visits.

Keywords: tibia fracture evos evos small plating system plates tibial fracture surgery open reduction internal fixation
resti registry: spanish registry of primary immune thrombocytopenia and other immune thrombocytopenia

Conditions: ITP - Immune Thrombocytopenia; Primary Immune Thrombocytopenia (ITP)

Summary: primary immune thrombocytopenia (pit), previously referred to as idiopathic thrombocytopenic purpura, is an acquired disease characterized by accelerated platelet destruction and deficient platelet production by megakaryocytes. although the existence of pit has been known for decades, there is no consensus on its triggering mechanisms. on the other hand, this disease presents a very heterogeneous patient profile, both in its characteristics and treatments. in this sense, the diagnosis is still made by excluding other causes of thrombocytopenia. there is insufficient epidemiological data on the disease, a fact that is especially evident in our country. we have no data on the incidence or prevalence of this pathology in spain. for all these reasons, this epidemiological study has been designed to increase the available knowledge about this disease and the detailed characterization of the population of patients with itp in spain. the main objective of this study is to describe the clinical, analytical and treatment characteristics of primary immune thrombocytopenia and other immune thrombocytopenia. the study is an epidemiological, ambispective, multicenter study carried out in hospitals in spain. information will be collected on the disease under study, as well as on the treatments received, using the patient's clinical history as a source document.


Eligibility criteria:
inclusion criteria: * children as young as 2 months of age and adults in follow-up since 2015 (irrespective of date of diagnosis) with the diagnostic presumption of pit or other thrombocytopenia of probable immune origin defined as a platelet count \< 100 x 109/l. * patients who have given written informed consent. in the case of deceased patients, the data will be included in the registry and the investigator will record the impossibility of collecting patient's informed consent form due to death. only patients deceased after december 31 2015, will be included exclusion criteria: * patients who, at the investigator's discretion, do not meet the conditions for inclusion in the study

Keywords: itp pti trombocitopenia inmune primaria primary inmune thrombocytopenia
mobile phone sensing and outreach as adjuncts to internet-based behavioral intervention for depression

Conditions: Depression

Summary: investigators are evaluating the use of phone sensor data to estimate behavior, depression and anxiety.

investigators are evaluating the use of phone sensor data to estimate behavior, depression and anxiety. participants will include people who are high on depression, high on anxiety, hight on both depression and anxiety, and health controls. particpants will load software on their phones that collects phone sensor data, and obtains self report on sleep, mood, and social contacts. data will be collected for at least 6 weeks.

Eligibility criteria:
inclusion criteria: * phq-9 score 10 or higher * has an e-mail account, computer, and broadband access to the internet * familiarity with mobile phones and is within a cellular network range the majority of the day. * is able to speak and read english. * is at least 19 years of age. exclusion criteria: * hearing or voice impairment preventing participation in psychotherapy. * visual impairment that would prevent use of the website, mobile phone application, and assessment materials. * has any psychiatric condition for which participation in a clinical trial of psychotherapy may be either inappropriate or dangerous (e.g., psychotic disorders, bipolar disorders, dissociative disorders, etc.). * planning to be out of town or unavailable for intervention for 1 or more weeks during the scheduled study participation. * exhibits severe suicidality, including ideation, plan, and intent.

Keywords: depression technology assisted mobile phone
fshd molecular characterization

Conditions: Facio-Scapulo-Humeral Dystrophy

Summary: to characterize the clinical and molecular phenotype of fshd.

the purpose of this study is to validate alterations in therapeutically relevant biomarkers in muscle tissue from fshd patients. these biomarkers are responsive to the upregulation of the dux4 gene and protein, which is the fundamental molecular defect in fshd. in anticipation of a future clinical trial, the investigators intend to assess the correlation between the expression of these relevant biomarkers and clinical functional measures. the investigators will also explore the utility of muscle mri in identifying regions of muscle suitable for sampling for relevant biomarkers, as mri-related signal changes have been proposed as an anatomic marker of early fshd pathology.

Eligibility criteria:
inclusion criteria: * 13 years or older * genetically proven fshd1 or fshd2 as determined by the investigators exclusion criteria: * inability to complete an mri scan (adults only). * other medical or cognitive issues that, in the opinion of the examiner, preclude accurate functional assessment.

Keywords: fshd
step away from depression - evaluation of a pedometer intervention with inpatients with major depression

Conditions: Depression

Summary: the purpose of this study is to determine if the use of pedometers can help depressive inpatients in psychiatric clinics to increase their level of physical activity. therefore patients are given a pedometer and instructions how to raise their level of daily steps. intervention group is compared with a control group that is receiving treatment-as-usual. the intervention is hypothesized to increase number of daily steps and have positive effects on mood, depression and anxiety.


Eligibility criteria:
inclusion criteria: * major depression, moderate to severe as main diagnosis * inpatient status * prospected inpatient treatment of at least 4 weeks * able to understand german exclusion criteria: * physical disease or disability that makes it impossible to reach the goal 5000 steps per day * borderline personality disorder * bipolar disorder * schizophrenia * anorexia nervosa * dementia * psychotic depression * pregnancy * acute suicidality * substance dependancies with actual consumption (except nicotine) * current pedometer-use * more than 10.000 steps per day

Keywords: physical activity mental health health behavior walking physical exercise mental disorder
contrast ultrasound for pediatric trauma - comparative evaluation (capture study)

Conditions: Abdominal Injury

Summary: this multicenter study aims to evaluate the accuracy of contrast-enhanced ultrasound (ceus) in diagnosing abdominal solid organ injuries in pediatric patients. up to 130 subjects will complete the study across approximately 5-10 sites in the us, with up to 30 patients in the training phase (3 per site) and 100 patients in the treatment phase of the study. all subjects will have had a ct scan as part of standard of care, confirming at least one solid organ abdominal injury. the study procedure will occur within 48 hours from time of injury. all subjects will have an abdominal ultrasound without contrast, followed by a contrast-enhanced ultrasound using the contrast agent lumason. ultrasound and contrast-enhanced ultrasound results will be compared to the ct scan results. the ct and ultrasound scans will be read locally and will undergo central review.

this is an interventional study which proposes to evaluate the accuracy of contrast-enhanced ultrasound (ceus) in diagnosing abdominal solid organ injuries in pediatric trauma patients. up to 130 subjects will be enrolled across approximately 5 to 10 sites in the us. each site, including the coordinating center, will undergo the training phase; each site will enroll 3 participants in this phase successfully prior to entering the treatment phase. all subjects will have had a computerized tomography (ct) scan as part of standard of care, confirming at least one solid organ abdominal injury. all subjects will have an abdominal ultrasound without contrast, followed by a contrast-enhanced ultrasound using the contrast agent lumason. ultrasound and contrast-enhanced ultrasound results will be compared to the ct scan results. the study procedures will take place within 48 hours of injury. at conclusion of enrollment of all subjects a centralized review of ct vs. ceus will occur to compare to real-time readings.

Eligibility criteria:
inclusion criteria: 1. hemodynamically stable, as determined by the trauma team 2. age 8 through 18 years (inclusive) 3. interpretable ct of the abdomen and pelvis that demonstrates at least one solid organ injury among the liver, spleen, pancreas, and kidneys 4. plan for observation or admission to the hospital 5. candidate for abdominal ultrasound based on body habitus, as determined by the investigator 6. glasgow coma score of 15 7. able to complete the study procedures within 48 hours of injury exclusion criteria: 1. known cardiac abnormality 2. pulmonary hypertension 3. known sensitivity to any lumason components - including sulfur hexafluoride, polyethylene glycol 4000, distearoylphosphatidylcholine (dspc), dipalmitoylphosphatidylglycerol sodium (dppg-na), or palmitic acid 4. unable to be rolled onto side to allow lateral ultrasound windows if necessary 5. unable to assent or consent 6. pregnant 7. lactating 8. ct images not available for transmission to central image repository

Keywords: solid organ injury
strategies to close the gap from cervical cancer diagnosis to treatment in botswana

Conditions: Cervical Cancer

Summary: investigators will test the effectiveness of adaptive strategies on timely adoption of cervical cancer treatment in botswana using a pragmatic trial design.

investigators will test the effectiveness of adaptive strategies on timely adoption of cervical cancer treatment in botswana using a hybrid (type iii) and pragmatic sequential multiple assignment randomized trial (smart) design. the adaptive strategies are designed to target patient- and system-level determinants identified in preliminary data, including delayed communication of results, individual and structural barriers to accessing treatment, and suboptimal care coordination between referring and cancer treatment clinics. the strategies draw upon key principles in behavioral economics and are supported by systematic evidence of the effectiveness of nudge strategies in preventive, hiv, and cancer care. the overarching rationale for the study is that enhancing coordination, communication, and navigation through centralized outreach and nudge strategies will increase timely treatment adoption and be scalable and sustainable in the long-term.

Eligibility criteria:
inclusion criteria: patients will be eligible if they: 1. are biological females 2. are aged 18 or older 3. have pathology-confirmed invasive cervical cancer diagnosis 4. have pathology results evaluated at national health laboratory in botswana 5. are citizens of botswana 6. have no prior history of invasive cervical cancer exclusion criteria: patients will be excluded if they: 1. are biological males or otherwise born without a cervix 2. are below the age of 18 due to the rarity of cervical cancer in this population 3. do not meet study inclusion criteria

Keywords: screening botswana treatment patient
irritability in children with adhd and emotion dysregulation

Conditions: Irritable Mood; ADHD

Summary: objective: emotion dysregulation is common among children with adhd and associated with a broad range of adult psychopathology, which is similar to the longitudinal outcomes of childhood irritability. however, the profiles of irritability in children with adhd and emotion dysregulation has been understudied. this study aimed to investigate the efficacy of methylphenidate and aripiprazole in the treatment of irritability in children with adhd and emotion dysregulation. in addition, the clinical profiles and neuropsychological characteristics of irritability in children with adhd were explored.

methods: a three-step, open-label, 10 week pilot study was conducted. methylphenidate (4 weeks), aripiprazole (4 weeks), and the combination (2weeks) were examined in sequence as the treatment for irritability in children with adhd and emotion dysregulation, defined by the cbcl-dysregulation profile. the primary outcome was improvement of irritability as measured by aberrant behavior checklist-irritability subscale (abc-i). during the first step, the subjects received pharmacological treatment of methylphenidate with flexible dosage for 4 weeks. those subjects who had suboptimal response to methylphenidate (reduction of abc-i score \< 25%) entered the second step and the medication was switched to aripiprazole. after 4 weeks of treatment, those whose abc-i scores reduced \< 25% entered the third step and received the treatment of combination of methylphenidate and aripiprazole for two weeks (3rd step). clinical profiles of irritability were evaluated with the affective reactivity index (ari), the strengths and difficulties questionnaire, the social adjustment inventory for children and adolescents, and the autism behavior checklist-taiwan version. the neurophysiological characteristics of the subjects were assessed by three cantab subtests: emotion recognition task, one touch stockings of cambridge, and spatial working memory. the aforementioned measurements were administered at baseline and at the end of each step.

Eligibility criteria:
inclusion criteria: * patients aged 6 to 18 who have adhd and emotion dysregulation, defined by the cbcl-dysregulation profile. exclusion criteria: * patients who are not willing to participate in the study after detailed explanation. * patients who have intellectual disability or could not follow the investigator's instructions. * patients who have severe neurological or mental illness like epileptic disorder, schizophrenia, bipolar disorder, or uncontrolled suicide risk. * patients who have severe medical illness or surgical conditions like uncontrolled abnormal thyroid function, or severe congenital heart disease. * patients who are allergic to methylphenidate or aripiprazole.
qubic stim cardiac stimulator in china

Conditions: Arrhythmia

Summary: 106 subjects selected from 3 study sites in china are with indications for intracardiac electrophysiological examination. the trial is to prove the clinical effectiveness and safety of qubic stim cardiac stimulator in chinese population.

the trial is a multicenter, prospective and single-arm study. 106 appropriate subjects were selected from 3 study sites in china in accordance with the inclusion and exclusion criteria. the subjects consent to participate in the trial and sign the informed consent. the subjects who meet the inclusion and exclusion criteria will receive the intracardiac electrophysiological examination, during which the subjects will be subject to diagnostic electrical stimulation by the qubic stim cardiac stimulator. the subjects will also receive the clinical follow-up visit after cardiac electrical stimulation until they are discharged from the hospital. the clinical effectiveness and safety of qubic stim cardiac stimulator in chinese population were proved by observing the data collected in this study.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years 2. subjects who are willing to participate and sign the informed consent form, and are able to finish the follow-up at the study site. 3. subjects with an indication of the intracardiac electrophysiological examination(fit one of the following): * paroxysmal supraventricular tachycardia: atrioventricular reentrant tachycardia or atrioventricular node reentrant tachycardia or atrial tachycardia. * ventricular arrhythmia: premature ventricular contraction or ventricular tachycardia. * atrial fibrillation. * atrial flutter. exclusion criteria: 1. previous cases of unsuccessful radiofrequency ablation or recurrence 2. pregnant and/or lactating women 3. acute or severe systemic infection was present within 7 days prior to the intracardiac electrophysiological examination 4. liver and kidney functions were obviously abnormal within 7 days prior to the intracardiac electrophysiological examination 5. obvious bleeding tendency or blood system disease 6. cancer and terminal disease 7. combined with severe organic cardiovascular disease 8. cerebral apoplexy and other cerebrovascular diseases within the past 3 months 9. thromboembolic disease 10. subjects who are participating in other interventional clinical trials

Keywords: paroxysmal supraventricular tachycardia ventricular arrhythmia atrial fibrillation atrial flutter