Kornimate/medical-research-clean huggingface dataset:
adjunctive oral hygiene aids in reducing oral hygiene parameters among orthodontic patients

Conditions: Gingival Bleeding; Dental Plaque Accumulation

Summary: adult orthodontic patients aged 18-30 were included in a randomised, singleblind clinical research using a split-mouth design at a dental clinic. both thewaterflosser® and the super-floss® water flossers are manufactured by oral-b.

in order to reduce gingival inflammation and remove subgingival plaque, oral hygiene therapy is necessary. the available evidence indicates that mechanical plaque control, which patients administer themselves daily, is the most important factor in managing and reducing plaque accumulation. aim: this research aimed to determine whether waterflosser or superfloss was more effective in lowering the gingival bleeding score and plaque. methods: adult orthodontic patients aged 18-30 were included in a randomised, single-blind clinical research using a split-mouth design at a dental clinic. both the waterflosser® and the super-floss® water flossers are manufactured by oral- b.

Eligibility criteria:
inclusion criteria: * participants aged 18-35 years undergoing orthodontic treatment and * systemically healthy without habits exclusion criteria: * participants not undergoing orthodontic treatment and participants undergoing orthodontic treatment in the included age category but with systemic conditions prevalent * missing teeth and * treated previously for periodontal conditions

Keywords: waterflosser superfloss gingival bleeding dental plaque
a study of eszopiclone co-administered with venlafaxine in subjects with major depressive disorder and insomnia

Conditions: Major Depressive Disorder; Insomnia

Summary: to evaluate the antidepressant effect of adjunctive treatment with eszopiclone in subjects receiving venlafaxine for the treatment of major depressive disorder (mdd).

this is a double-blind, randomized, placebo-controlled, parallel-group study. the study consists of two groups of subjects with major depressive disorder randomized to treatment with either eszopiclone 3 mg or placebo nightly at bedtime for 31 weeks beginning the night of visit 2. in addition, all subjects will receive open-label treatment with venlafaxine. safety and efficacy will be evaluated using clinical observations as well as physician and subject administered ratings scales. this study was previously posted by sepracor inc. in october 2009, sepracor inc. was acquired by dainippon sumitomo pharma., and in october 2010, sepracor inc's name was changed to sunovion pharmaceuticals inc.

Eligibility criteria:
inclusion criteria: * subjects must be male or female between the ages of 18 and 64, inclusive, at the time of signing consent. * subjects must have a primary diagnosis of major depressive disorder (mdd) by dsm-iv criteria (296.xx) as determined by the mini international neuropsychiatric interview (m.i.n.i.). * mdd must be the condition that was chiefly responsible for motivating the subject to seek treatment. * subjects must have a 17-item hamilton depression scale (ham-d-17) total score of \> 22 at the screening visit. exclusion criteria: * subjects who have a ham-d-17 total score \< 18 at visit 2 will be discontinued from the study. * all subjects who do not meet dsm-iv criteria (307.42) for insomnia related to a major depressive disorder. * subjects with less than a total sleep time \< 6.5 hours at least three times per week over the past month.

Keywords: insomnia depression major depressive disorder
neurothrombectomy france

Conditions: Cerebral Artery Occlusion

Summary: the ischemic brain vascular accident (cva) is a major public health issue. an early and appropriate charging anyone with stroke is essential to reduce mortality, reduce dependency and promote recovery of autonomy. intravenous fibrinolysis in patients with cerebral infarction (ninds 1995), is reserved for a small proportion of highly selected patients. it therefore remains a significant therapeutic challenge, especially for patients with against-indications to fibrinolysis or in whom there is no immediate benefit. for twenty years of mechanical devices have been developed to remove, as quickly as possible, the cause of intracranial arterial occlusion and allow restoration of blood flow before brain damage is irreversible. ntf the protocol is part of the evaluation process of our clinical practices recommended by the national health authority (has), in the specific context of mechanical thrombectomy performed in french centers of interventional neuroradiology working with neurovascular units (a v).


Eligibility criteria:
inclusion criteria: * signature of the information notice by the patient or his legal representative * age\> 18 years * clinical and imaging consistent with ischemic stroke whose symptoms start back within 8h * thrombosis (tici 0 or 1) of the carotid t, m1, m1-m2 bifurcation of the basilar artery occlusion in tandem aci / m1. exclusion criteria: * pregnant or lactating women * rapid improvement of nihss (gain of more than 4 points) between two pre-treatment assessments. * aspect score \<7 on the scanner or \<5 on the diffusion-weighted imaging (dwi) * intracranial hemorrhage on imaging * inability of clinical evaluations at 3 months * extensive lesions of the brain stem (the presence of a complete section of the brainstem hyperintense b1000) * 0 refusal to participate in the study
cognitive anxiety sensitivity treatment for suicide

Conditions: Anxiety

Summary: the purpose of this study is to test the effectiveness and usability of a computer-based treatment for mood and anxiety relevant risk factors. the target of the treatment is related to cognitive stress, which has been shown to be associated with several negative mental health outcomes such as suicidal ideation, substance use disorders, and post-traumatic stress disorder.

cast is a newly developed computerized treatment targeting specific risk factors associated with ptsd, substance use, anxiety, and suicide. eligible individuals will be randomized to one of two conditions. in both conditions, participants will complete various self-report questionnaires and a computerized presentation. additionally, all participants will be asked to complete a one month follow-up appointment.

Eligibility criteria:
inclusion criteria: * at or above the community sample mean on the asi * english speakers * 18 years of age or older exclusion criteria: * significant medical illness * current substance dependence * current or past psychotic-spectrum disorders * uncontrolled bipolar disorder * serious suicidal intent that warranted immediate medical treatment
validation of a patient decision aid for type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: the objectives of this study are to compare measurements in knowledge of decision options, support for decision making, uncertainly in decision making, and clarity of values important to decision making among two groups of type 2 diabetes patients, those who receive a patient decision aid and those who receive usual care.

this study uses a randomized, controlled trial design to compare knowledge of decision options, support for decision making, uncertainly in decision making, and clarity of values important to decision making among patients with uncontrolled type 2 diabetes who are only taking metformin medication. the intervention is a patient decision aid (pda) video delivered via the internet.

Eligibility criteria:
inclusion criteria: 1. type 2 diabetes 2. age 18 or older 3. english speaking 4. currently taking metformin 5. inadequate glycemic control in the opinion of the investigator 6. is considering additional medication options on the advice of their physician 7. can provide a valid email address 8. access to the internet and able to read and respond to internet questionnaires exclusion criteria: 1. participation in a clinical trial of a diabetes medication within 1 year 2. currently taking more than two (2) medications for diabetes 3. has been exposed to diabetes medications from more than three (3) drug classes 4. adults unable to consent 5. individuals who are not yet adults (infants, children, teenagers) 6. pregnant women 7. prisoners

Keywords: patient decision aid shared decision making
effectiveness of the pilates method versus aerobic exercises in elderly with low back pain

Conditions: Low Back Pain

Summary: chronic low back pain is potentially disabling for the elderly, and physical exercises are considered the best treatment for this problem. the pilates method has been proven effective in the improvement of pain and function in patients with low back pain. however, the evidence about the effectiveness of pilates method in the treatment of elderly patients with low back pain is scarce. thus, the aim of this study is to investigate the effectiveness of the pilates method compared to aerobic exercise in elderly with chronic non-specific low back pain. this randomized controlled trial with two arms and blinded assessor will include 74 patients aged between 65 and 85 years, of both sexes, complaining of chronic non-specific low back pain persisting for more than three months and pain intensity greater than 3 points in the pain numerical rating scale. the elderly will be randomized into two groups: pilates group (n = 37) with exercises based on pilates method; and aerobic group (n = 37) with aerobic exercises, stretching and relaxation. both groups will hold treatment twice a week with duration of 60 minutes for eight weeks. the primary outcomes will be: pain intensity and general disability assessed eight weeks after randomization. secondary outcomes will be: pain intensity and general disability evaluated six months after randomization; global impression of improvement, specific disability and dynamic balance, muscle strength of the gluteus maximus, gluteus medius and lateral hip rotators and pressure pain threshold evaluated eight weeks and six months after randomization. we expect that the results of this study contribute to the clinical decision-making with respect to pain reduction and, consequently, improving balance and functionality of elderly with chronic low back pain.


Eligibility criteria:
inclusion criteria: * elderly complaining of non-specific low back pain for more than three months * pain intensity equal to or more than 3 points evaluated by the pain numerical rating scale in the last seven days. exclusion criteria: * contraindication to physical exercise; * back with severe disease (fractures, tumors, inflammatory diseases, ankylosing spondylitis and nerve root compromise confirmed by neurological tests); * previous or scheduled back surgery ; * severe cardiorespiratory disease; * cancer; * cognitive impairment; * dependent gait; * patients who underwent physical therapy for low back pain in the last six months; * regular physical activity practitioners.
myocardial perfusion assessment with multidetector computed tomography

Conditions: Coronary Artery Disease

Summary: demonstrate the ability of muti-detector computed tomography to adequately perform stress testing will result in a veritable "one-stop shop" of non-invasive cardiac imaging that is, the ability to directly visualize heart arteries with high accuracy and to simultaniously determine the hemodynamic significance of any blockages visualized.


Eligibility criteria:
inclusion criteria: * adults \>18 years of age * adults undergoing myocardial perfusion spect imaging * adults with suspected coronary artery disease exclusion criteria: * age \<18 * known or suspected renal insufficiency (creatinine \<1.7 mg/dl) * allergy to contrast * inability or contraindication to lexiscan or beta blocker

Keywords: coronary artery disease stress testing
keeping active in residential elderly

Conditions: Frail Elderly Syndrome; Frailty; Physical Activity

Summary: this trial will take the form of a feasibility study; designed to assess the feasibility of a proposed future clinical trial in this setting. this proposed future clinical trial is proposed to assess the impact of physical activity, in the form of specialised chair based physical activity intervention, on the physiological, psychological, cognitive, social and emotional health, and functional capacity of geriatric populations with pre-existing frailty within a residential care setting; recognising health as a holistic concept incorporating a multitude of inter-related dimensions. this feasibility study is single-centre (taking place at the olivet christadelphian care home, 17 sherbourne road, acocks green, birmingham, united kingdom ).


Eligibility criteria:
inclusion criteria: * residents within the olivet christadelphian care home, 17 sherbourne road, acocks green, birmingham, united kingdom * ≥ 65 years of age * frail according to the fried frailty criteria: meeting at least three of the five characteristics of frailty (fried et al. 2001) * have the capacity to speak and read in english exclusion criteria: * currently taking part in any other clinical trial which could potentially have an impact upon or influences the findings of the current study * currently terminally ill with life expectancy which is less than the duration of the follow-up of the study * severe sensory impairment which would profoundly impact on their capacity to undergo the interventions, even once appropriate adaptations have been made.

Keywords: frailty physical activity resistance training
exercise therapy after pulmonary thromboendarterectomy or balloon pulmonary angioplasty for chronic thromboembolic pulmonary hypertension

Conditions: Chronic Thromboembolic Pulmonary Hypertension

Summary: this study is being completed to determine the feasibility and acceptability of completing a home-based, structured, low-to-moderate intensity exercise training program in chronic thromboembolic pulmonary hypertension (cteph) patients following surgical or percutaneous intervention. eligible participants will be enrolled and have a 12 week home based exercise training program. the study team hypothesizes that: the following percentage of participants successfully complete the ramp-up phase of the exercise program: * greater or equal to 70% at end of week 7 * greater or equal to 80% at end of week 10 * greater or equal to 90% at end of week 12 * greater or equal to 80% of participants will both complete ≥1 week of maintenance phase exercise and complete 12 weeks of the exercise intervention. * patients will have no adverse events, defined as syncope, worsening world health organization (who) functional class, pulmonary hypertension (ph) related hospitalization, or death, caused by the exercise intervention.


Eligibility criteria:
inclusion criteria: * chronic thromboembolic pulmonary hypertension (cteph) patients post-pulmonary thromboendarterectomy (pte) or balloon pulmonary angioplasty (bpa) * planned follow-up at michigan medicine for at least one year * has access to an android or iphone with study supported operating software, is willing to install mydatahelps application, and is willing to wear a smart watch while awake exclusion criteria: * life expectancy under 1 year * orthopedic, neurological, or psychiatric condition limiting ability to actively engage in exercise training session * currently receiving palliative care and/or in hospice care * persistent severe right ventricular (rv) dysfunction on echocardiography post bpa or pte * recently completed, current enrollment, or planned enrollment in pulmonary rehabilitation * moderate or severe obstructive lung disease or restrictive lung disease * arterial oxygen saturation (spo2) \<88% during 6 minute walk test(6mwt) on baseline home oxygen prescription * wrist too large to wear a smart watch comfortably. * participant noted to wear smart watch for less than 8 hours per day prior to intervention. * determined to be unsafe for participation in exercise therapy as assessed by the clinical team. * those with mobility issues that are unable to complete 6mwt. * participant has sex minute walk distance (6mwd) greater or equal to 90% predicted at visit 1. * pregnancy or lactation * non-english speaking

Keywords: exercise balloon pulmonary angioplasty pulmonary thromboendarterectomy smart watch treadmill exercise test
esophagectomy for patients with esophageal cancer and cervical lymph node metastases

Conditions: Cancer; Squamous Cell Carcinoma; Adenocarcinoma; Malignancy

Summary: there is no world-wide consensus on the oncological benefit versus increased morbidity associated with three field lymphadenectomy in patients with esophageal cancer and cervical lymph node metastases. in asian countries, esophagectomy is commonly combined with a three field lymphadenectomy, including resection of cervical, thoracic and abdominal lymph nodes. however, in western countries patients with cervical lymph node metastases are generally precluded from curative treatment.

objective: to assess the safety and feasibility of curative esophagectomy combined with three field lymphadenectomy after chemo-radiation in western patients with resectable thoracic esophageal carcinoma and cervical lymph node metastases. secondary objective is to determine the effect on survival and recurrence. study design: mono centre prospective phase ii single-arm feasibility study. study population: western patients diagnosed with resectable (ct1-4a, n1-3) intra thoracic esophageal carcinoma with histological or cytological proven cervical lymph node metastases in level iii and/ or iv. intervention: transthoracic esophageal resection combined with three field lymphadenectomy after neoadjuvant chemo-radiation. main study parameters/ endpoints: primary outcome is the percentage of overall surgical complications grade 3b and higher as stated by the modified clavien-dindo classification. secondary outcomes are mortality, operation related events and postoperative recovery, including quality of life, disease free survival, overall survival and if applicable the location of recurrent disease.

Eligibility criteria:
inclusion criteria: * histologically proven squamous cell carcinoma or adenocarcinoma of the esophagus. * surgical resectable carcinoma (t1-4a, n1-3) (table 1) * histologically/ cytologically proven resectable cervical lymph node metastases level iii and/ or iv * age ≥ 18 * european clinical oncology group (ecog) performance status 0,1 or 2 * written informed consent exclusion criteria: * distant metastases * esophageal carcinoma \< 3 cm beneath ues * carcinoma of the gastro-esophageal junction (gej) with major tumor in the gastric cardia (siewert iii) * former radiotherapy or chemotherapy for esophageal carcinoma * former radiotherapy precluding radiotherapy according the cross protocol * inadequate pulmonary function disabling transthoracic resection * \>10% loss of weight in the last six months * previous neck dissection * new york heart association class iii/iv and no history of active angina. patients with a history of significant ventricular arrhythmia requiring medication or congestive heart failure. history of 2nd or 3rd degree heart blocks

Keywords: three-field lymphadenectomy cervical metastases esophagectomy
post-operative crp trend after ileocolic resection in crohn's disease patients.

Conditions: Crohn Disease

Summary: our aim is to analyze c-reactive protein trends during the post-operative course in crohn's disease patients having undergone ileocolic resection and primary anastomosis, for the purpose of anastomotic leak early diagnosis.


Eligibility criteria:
inclusion criteria: * crohn's disease patients * primary ileocolic anastomosis * c-reactive protein data available in medical file exclusion criteria: * protective stoma * associated resection with or without anastomosis during intervention

Keywords: crohn disease anastomotic leak c-reactive protein
safety and efficacy of ctap101 to treat secondary hyperparathyroidism in stage 3 or 4 ckd and vitamin d insufficiency

Conditions: Chronic Kidney Disease; Hyperparathyroidism, Secondary; Vitamin D Deficiency

Summary: this study will evaluate the efficacy of ctap101 capsules versus placebo in reducing intact parathyroid hormone (ipth) by at least 30% from pretreatment baseline; safety and tolerability of ctap101 will also be evaluated

this is a phase 3, multi-center, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of ctap101 capsules administered for 26 weeks to treat shpt in subjects ≥18 years of age with stage 3 or 4 ckd and vitamin d insufficiency. the study will be conducted at approximately 40 sites within the united states (us). approximately 550 subjects will be screened to randomize approximately 210 eligible subjects, stratified by ckd stage (approximately 105 subjects in each stage) in a 2:1 ratio to receive either ctap101 capsules or matching placebo. an interactive voice response system (ivrs) will provide study treatment group assignments using the computer-generated randomization code provided by the ivrs vendor. subjects will receive an initial daily dose of 1 capsule (ctap101 capsules, 30 µg, or matching placebo) for the first 12 weeks. after l2 weeks (visit 8) and per pre-defined criteria, the dose may be increased in a blinded fashion by the ivrs with oversight by an independent medical monitor.

Eligibility criteria:
inclusion criteria: 1. urinary albumin excretion ≤ 3000 mcg/mg of creatinine 2. stage 3 or 4 ckd 3. plasma ipth: ≥ 85 pg/ml and \< 500 pg/ml 4. serum ca: ≥ 8.4 mg/dl and \< 9.8 mg/dl 5. serum p: ≥ 2.0 mg/dl and \< 5.0 mg/dl 6. serum 25-hydroxyvitamin d: ≥ 10 ng/ml and \< 30 ng/ml. 7. stable dose of vitamin d therapy ≤ 1600 iu/day and receiving same dose for at least 2 months exclusion criteria: 1. history of kidney transplant or parathyroidectomy 2. spot urine calcium:creatinine ratio \> 0.2 (\>200 mg/g cr) 3. current serious illness, such as malignancy, hiv, liver disease, cardiovascular event or hepatitis 4. currently on dialysis 5. use of pharmacological dose of ergocalciferol or cholecalciferol (≥ 50,000 iu mcg per month) during the study

Keywords: parathyroid diseases renal insufficiency kidney failure, chronic hyperparathyroidism, secondary vitamin d hyperparathyroidism kidney diseases kidney failure renal insufficiency, chronic