Kornimate/medical-research-clean huggingface dataset:
a comparative study of emg biofeedback and pharmacotherapy for the treatment of masticatory muscle hyperactivity in bruxism patients

Conditions: Bruxism

Summary: this study examines the effect of electromyography biofeedback on masticatory muscles hyperactivity on patients with bruxism.

bruxism is a movement disorder characterized by excessive activity of the masticatory muscles, resulting in teeth clenching and grinding. it affects 50% to 95% of the adult population. unlike normal, voluntary chewing movements associated with eating, bruxism involves involuntary jaw muscle contractions that cause tension, leading to muscle soreness and pain. common symptoms include localized muscle tenderness, orofacial pain, anxiety, stress, fatigue, headaches (especially in the temporal region), restricted mouth opening, and temporomandibular joint stiffness. these symptoms can disrupt sleep, causing transitions from deep to light sleep, increased micro-arousals, and sleep fragmentation, leading to daytime fatigue that impacts social life and work performance. bruxism can also lead to masticatory muscle hypertrophy (especially the masseter), tongue burning, linea alba on the cheeks, excessive tooth wear, damage to dental prosthetics, changes in saliva secretion, severe craniofacial pain, and tmj stiffness. common treatments for bruxism-related pain often involve medications like botox, clonazepam, or diazepam, but these are typically temporary and do not address the underlying causes. moreover, long-term use of these medications may cause complications, and their high cost can limit accessibility. non-pharmacological treatments for bruxism include biofeedback, muscle relaxation exercises, occlusal splint therapy, and psychotherapy. biofeedback, which provides real-time information on bodily functions, helps individuals recognize and modify harmful behaviors. electromyography (emg) biofeedback, recognized as effective for temporomandibular disorders (including bruxism), is endorsed by the american association of psychophysiology and biofeedback (aapb) as an evidence-based intervention. this study aims to compare the effects of emg biofeedback training versus oral medications in reducing masticatory muscle hyperactivity in bruxism patients, focusing on addressing the underlying pathophysiology, a topic that, to the authors' knowledge, has not been explored in previous research.

Eligibility criteria:
inclusion criteria: * twenty adult subjects with definite mild to moderate bruxism examined by a dentist prior to the study. * tenderness of masticatory muscles on palpation grade one and two according to the digital palpating scale * mild to moderate myofascial pain around the temporomandibular joint causing discomfort in the morning. exclusion criteria: * took any botox or prp injection treatment for this condition for the last six months * had any advanced periodontal disease. * any intraoral fixed splints. * pregnancy. * under psychiatric care. * parkinson * have any visual or auditory impairment. * any cervical posture abnormalities.
eit in ards for tcav setting (east study)

Conditions: ARDS

Summary: acute respiratory distress syndrome (ards) is a severe form of acute respiratory failure. the therapeutic management is currently based on the treatment of the cause of ards, and on mechanical ventilation with positive expiratory pressure (peep). another strategy that could be used is time controlled adaptive ventilation (tcav) method based on ventilation using the airway pressure release ventilation (aprv) mode. electrical impedance tomography (eit) allows individual, non-invasive, real-time, bedside, radiation-free imaging of an anteroposterior section of the right and left lungs, with global and regional dynamic analyses. the aim of the study is to evaluate eit for phigh titration of tcav.

acute respiratory distress syndrome (ards) is a severe form of acute respiratory failure with a mortality rate of up to 35% for the most severe forms. the therapeutic management is currently based on the treatment of the cause of ards, and on mechanical ventilation with positive expiratory pressure (peep). another strategy that could be used is time controlled adaptive ventilation (tcav) method based on ventilation using the airway pressure release ventilation (aprv) mode. the tcav method is based on a prolonged thigh set at a constant pressure, creating a continuous positive pressure phase associated with a brief release during a tlow allowing the elimination of carbon dioxide and the creation of an intrinsic peep. with long high pressure phase this method could result in better recruitment but could also expose the patient to overdistention. while the tlow setting is well defined, level of phigh is not standardized. electrical impedance tomography (eit) allows individual, non-invasive, real-time, bedside, radiation-free imaging of an anteroposterior section of the right and left lungs, with global and regional dynamic analyses. results of recent studies have highlighted the benefits of eit, especially for ards patients in titrating peep in volume-controlled ventilation. to date, no published study has evaluated eit for phigh titration using the tcav method in patients with severe ards.

Eligibility criteria:
inclusion criteria: * moderate to severe ards patients with more than 24 hours of mechanical ventilation * under sedation with a richmond rating scale less than or equal to -2. exclusion criteria: * patients with a pacemaker or automatic implantable defibrillator * pregnant women. * contraindications to chest belt placement (e.g., spinal or thoracic recent surgery) * undrained pneumothorax, broncho-pleural fistula * hemodynamic instability (i.e., use of vasopressors at \> 2 ug.kg.min of norepinephrine) * patients on mechanical ventilation during more than 7 days

Keywords: ards tcav eit aprv
significance of synbiotics on inflammation and proliferation of colonic mucosa

Conditions: Inflammation

Summary: there is a constant exchange between the gut epithelium and lumen, including microbial interplay. the aim of this study was to investigate dietary test products on inflammatory proliferation markers in the gut, and thereby if the products had positive effects in the gut as well as in other parts of the body. the hypothesis was that the test products would reduce the inflammatory and proliferation activity of the gut epithelium by fermentation of normal food products and by converting dietary phenolic compounds into anti-inflammatory substances.


Eligibility criteria:
inclusion criteria: * 18-80 years old, * able to understand oral and written information, * informed consent exclusion criteria: * ongoing immune suppressive treatment, incl. cortisone, * ongoing antibiotic treatment or antibiotic treatment ended within 4 weeks, * history of inflammatory bowel disease
attentional bias retraining in veterans

Conditions: Posttraumatic Stress Disorder

Summary: the study has two goals. first to develop a computer-based intervention meant to alter cognitive biases that contribute to ongoing ptsd symptoms. second, we sought to pilot test the intervention in a small sample of veterans for feasibility and acceptability.

aim 1: develop attentional bias retraining protocol (phase 1) * 1.1 computerized assessment \& retraining programs * 1.2 procedures and measures aim 2: implement in pilot sample (phase 2) * 2.1: assess feasibility and tolerability * 2.2: collect pilot data to plan future studies * 2.3: efficacy estimates based on changes in response time to dot probe task

Eligibility criteria:
inclusion criteria: * participated in ground combat operations in vietnam * scored 40 - 80 on ptsd checklist - military version * availability and willingness to attend 2x weekly computer sessions for 6 weeks exclusion criteria: * active substance dependence * significant cognitive impairment * current and active suicidal or homicidal ideation
evaluate safety and effectiveness of mbx-102 in type 2 diabetes patients with poor glycemic control on metformin

Conditions: Type 2 Diabetes Mellitus

Summary: to define the relative efficacy, safety and tolerability profiles of oral daily mbx-102 at daily doses of 400 and 600 mg vs. placebo and actos® 30 mg (up-titrated to 45 mg after 8 weeks) when administered for up to 24 weeks in patients inadequately controlled with a stable dose of metformin (≥ 1500 mg/day).

approximately 240 patients will be randomized in this study, 60 to each of two mbx-102 treatment groups (400 and 600 mg daily), 60 to placebo, and 60 to the actos® group. patients in the actos® group will receive actos® 30 mg/daily for the first eight weeks of the treatment phase and actos® 45 mg/daily for the last 16 weeks of the treatment phase. patients in the mbx-102 400 mg group and mbx-102 600 mg group will continue mbx-102 400 mg and 600 mg, respectively for the full 24 weeks. all study medication will be over-encapsulated; thus, each patient will take two blinded capsules each day containing either placebo, mbx-102 or actos®. this sample size provides the minimum number expected to ensure a power of at least 90% in detecting a difference of 0.64% in hba1c between the placebo and experimental treatment, using a two-tailed, two-sample t-test with type 1 error of 0.05, when the pooled standard deviation is ≤ 1.0%, and the discontinuation rate is ≤ 12.5%.

Eligibility criteria:
inclusion criteria: * patients with type 2 diabetes who have been on metformin for the last 6 months and are taking a stable dose of metformin (≥ 1500 mg/d) as monotherapy for at least the last 3 months * male or female, 18-70 years of age * all female patients must be surgically sterile or post-menopausal (at least 40 years of age with no history of menses for at least 2 years; or any age with no history of menses for at least 6 months and serum fsh ≥ 40 miu/ml) or must agree to use two medically accepted methods of contraception including a barrier method. depo contraceptives are excluded. * female patients must not be pregnant or lactating * bmi ≥ 26 (patients of asian indian origin ≥ 22) kg/m2 * hba1c ≥ 7.5%, ≤ 10.5% * fpg ≥ 120 mg/dl, ≤ 240 mg/dl exclusion criteria: * history of diabetes secondary to pancreatitis or pancreatectomy * any history of ketoacidosis * history of insulin use within last one year (insulin use while hospitalized is acceptable) * weight loss \> 10 pounds in the three months prior to screening visit * history of tzd use (actos® or avandia®) within 6 months of screening visit * history of tzd discontinuation due to side effect or lack of efficacy
zero-ischemia robot-assisted partial nephrectomy using near-infrared fluorescence

Conditions: Renal Cancer

Summary: patients with renal cancer are commonly treated by robot-assisted partial nephrectomy. renal artery clamping is commonly required inducing kidney ischemia during surgery. it impacts parenchymal and renal function. this study aims to compare a new surgical procedure in order to reduce ischemia effect and preserve renal function after partial nephrectomy for renal tumour.


Eligibility criteria:
inclusion criteria: * candidate for a robot-assisted partial nephrectomy for renal tumour * patient affiliated to social security * signature of the informed consent exclusion criteria: * proven or suspected allergy to the indocyanine green * coagulation disorder contraindicating robot assistance in the partial nephrectomy * medical pathology contraindicating pneumo-peritoneum * multiple tumors * horseshoe kidney * exclusion period of another interventionnal study * protected person referred to in articles l1121-5 to l1121-8 of the code of public health

Keywords: partial nephrectomy robot-assisted surgery near-infrared fluorescence ischemia
safety and efficacy study of duotrav aps versus duotrav

Conditions: Open-angle Glaucoma; Ocular Hypertension

Summary: the purpose of the study is to demonstrate that the iop-lowering efficacy of duotrav aps, dosed once-daily in the morning, is non-inferior to that of duotrav, dosed once-daily in the morning.


Eligibility criteria:
inclusion criteria: * patients with open-angle glaucoma or ocular hypertension who would benefit from a fixed combination medication, in the opinion of the investigator and who are currently on a stable treatment of iop-lowering medication exclusion criteria: * va not worse than 0.60 * additional clinically relevant ocular or systemic conditions may be excluded

Keywords: open-angle glaucoma ocular hypertension open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component)
longitudinal study of patients following long bone fracture

Conditions: Vitamin D; Long Bone Fracture

Summary: studies in chickens show that blood levels of a particular form of vitamin d (called 24,25-dihydroxvitamin d) increase after bone fracture. laboratory studies show that this form of vitamin d helps the bone healing process in chickens. the investigators want to find out whether blood levels of this form of vitamin d increase after bone fracture in humans. previous research studies have not addressed this question. the results of this research could eventually lead to the development of new treatments to help bone healing after fracture. patients will be asked to take part in this study if they are aged 16 years or older and come to the royal london hospital with a broken bone in the arm or leg or collar bone (clavicle). they will be asked to give a 20ml (about 4 teaspoons) blood sample on three occasions: at the start of the study, at 5-14 days after the fracture; and at 4-10 weeks after the fracture. the rest of their normal care would not be affected. follow-up blood samples will be timed to coincide with routine clinic visits which are scheduled as part of normal clinical care. patients' vitamin d level will be measured as part of the study, and those who have a low vitamin d level will be informed about this, and advised about appropriate vitamin d supplementation. the investigators will let the patient or their gp know if any blood tests are abnormal


Eligibility criteria:
inclusion criteria: 1. any cross-shaft long bone or clavicle fracture within last 12 hours 2. able to give written informed consent 3. age ≥ 16 years 4. fused physes (physiologically adult) exclusion criteria: 1. taking medication affecting vitamin d metabolism - carbamazepine, phenobarbital, phenytoin or primidone 2. taking vitamin d supplement \> 800 iu/day 3. abdominal visceral injury, pleural injury (except pneumothorax), spinal cord injury, or gcs \< 15 at presentation to hospital 4. known paget's disease, osteopetrosis, metastatic bone cancer, or primary bone cancer 5. current prisoners 6. currently taking part in another clinical research project
internet-based treatment for insomnia

Conditions: Psychophysiologic Insomnia

Summary: the study will test an internet-based treatment for insomnia.

this study will develop and evaluate the feasibility of a cost-effective, more accessible alternative treatment approach for insomnia. traditional cbt, including the behavioral, cognitive, and educational aspects, will be operationalized and transformed for an internet intervention system, so individuals can access a personalized treatment any time, at their own convenience. phase 1 of this study will involve developing the web program. the investigators research team and collaborators has extensive experience developing such web interventions, as well as considerable experience with insomnia. phase 2 will be a large randomized controlled trial testing the internet intervention compared to passive patient education/sleep hygiene. two hundred individuals with insomnia will be assessed pre and post the six week treatment program. it is hypothesized that the internet intervention will promote improvements in sleep, mood, and cognitive functioning. if successful, the current project may result in improved implementation of a low-threshold treatment for a common disorder with devastating impact on both individual and socioeconomic outcomes

Eligibility criteria:
inclusion criteria: 1. age 18 years or older 2. fulfillment of the dms-iv criteria for insomnia 3. duration of at least 3 months 4. complaints of impaired daytime functioning exclusion criteria: 1. presence of a major depressive disorder or other severe mental disorder as identified by in the telephone interview 2. working night shifts and unable to discontinue this work pattern 3. having a serious somatic condition preventing further participation.
long-term of 10 years results of a prospective longitudinal study

Conditions: Type 2 Diabetes Mellitus; Blood Pressure

Summary: previous cross-sectional studies have demonstrated that blood pressure (bp) measurements at home (hbp) in the morning offer stronger predictive power for micro- and macrovascular complications in patients with type 1 and 2 diabetes than casual/clinic blood pressure measurements (cbp) (kamoi k et al, 2002-2003). further, a prospective, longitudinal study for 6 years in patients with type 2 diabetes also demonstrated that control of wakening-up hbp provides the stronger predictive power for the outcomes than that of cbp did (kamoi et al, 2010). however, it is not clear to show which of bp measurement provides the stronger predictive power for outcomes by comparing cumulative events over a longer time than 6 years. therefore, the investigators examined which of hbp or cbp provides the stronger predictive power for outcomes in addition of renal anemia reported previously over 10 years in the patients with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * after a detailed baseline examination, 400 japanese subjects with type 2 diabetes reported previously are followed up for all-cause mortality and morbidity. exclusion criteria: * other than the above, patients judged inappropriate as the subjects of this study by the investigator
safety study of alrn-6924 in patients with acute myeloid leukemia or advanced myelodysplastic syndrome

Conditions: Acute Myeloid Leukemia; Myelodysplastic Syndromes

Summary: phase 1/1b, open label, multi-center dose escalation and dose expansion study designed to evaluate safety, tolerability, pk (pharmacokinetics), pd (pharmacodynamics) and anti-tumor effects of alrn-6924 alone or in combination with cytarabine in patients with relapsed/refractory acute myeloid leukemia or advanced myelodysplastic syndrome with wild-type (wt) tp53

phase i, open label, multi-center dose escalation (dep) and dose expansion (exp) study designed to evaluate safety, tolerability, pk (pharmacokinetics), pd (pharmacodynamics) and anti-tumor effects of alrn-6924 in patients with acute myeloid leukemia or advanced myelodysplastic syndrome with wild-type (wt) tp53. alrn-6924 is a stabilized cell-permeating peptide designed to disrupt interaction between the p53 tumor suppression protein and its endogenous inhibitors murine double minute 2 (mdm2) and murine double minute x (mdmx) men and women 18 years of age and older with relapsed or refractory acute myeloid leukemia or advanced myelodysplastic syndrome and for which standard treatment(s) are not available or are no longer effective can be enrolled. treatment of patients in the dep and exp phases will continue in the study until documentation of disease progression, unacceptable toxicity, or patient or physician decision to discontinue study participation is made.

Eligibility criteria:
inclusion criteria: * relapsed or refractory acute myeloid leukemia or ipss-r intermediate/high/very high-risk mds patients * confirmed or anticipated wild-type tp53 * ecog (eastern cooperative oncology group) performance status 0-2 * adequate hepatic and renal function * acceptable coagulation function * negative serum or urine pregnancy test within 7 days prior to the first dose of alrn-6924 for women of child-bearing potential * sufficient wash out from prior therapies and recovery from all significant toxicities exclusion criteria: * patients are eligible for available approved standard therapies * prior treatment with mdm2 inhibitor, with protocol specified exceptions * patients with history of allogeneic stem cell transplantation * leukemic blast counts of \>25,000/µl * deletion of chromosome 17, or del(17p) * patients with evidence of current central nervous system leukemic involvement * known hypersensitivity to any study drug component * history of coagulopathy * prior specified cardiovascular risk factors * clinically significant gastrointestinal bleeding within 6 months * clinically significant third-space fluid accumulation * pregnant or lactating females * evidence of any serious and/or unstable pre-existing medical condition that would interfere with patient safety ability to provide informed consent * active uncontrolled infection, including hiv/aids or hepatitis b or c * second malignancy within one year, with protocol specified exceptions
expanded access protocol to provide lumasiran to patients with primary hyperoxaluria type 1

Conditions: Primary Hyperoxaluria

Summary: the purpose of this study is to provide expanded access to lumasiran for adults and pediatric patients with primary hyperoxaluria type 1 (ph1),

choosing to participate in an expanded access program is an important personal decision. talk with your doctor and family members or friends about deciding to join a research study. to learn more about this study, please have your doctor contact the study research staff using the contacts provided. for general information, see the link provided in more information.

Eligibility criteria:
inclusion criteria: * documented diagnosis of primary hyperoxaluria type 1 exclusion criteria: * clinically significant health concerns (with the exception of ph1) * received an investigational agent within 30 days before the first dose of lumasiran or are in follow-up of another clinical study * previously or currently participating in lumasiran clinical study * history of liver transplant

Keywords: hyperoxaluria primary hyperoxaluria kidney diseases urologic diseases metabolism, inborn errors genetic diseases, inborn metabolic diseases rna therapeutic sirna
neoadjuvant hormonal therapy compared to neoadjuvant chemotherapy in stage iiib/c and iv breast cancer patients

Conditions: Breast Cancer

Summary: this study compared long term outcome of stage iiib/c and iv breast cancer patients treated with neoadjuvant hormonal therapy (naht) and those treated with neoadjuvant chemotherapy (nact)

this study compared long term outcome of stage iiib/c and iv breast cancer patients treated with neoadjuvant hormonal therapy (naht) and those treated with neoadjuvant chemotherapy (nact) between 2011 and 2016. the primary end points are overall survival (os) and progression free survival (pfs) with kaplan meier. this study was approved by ethical committee in dharmais national cancer hospital.

Eligibility criteria:
inclusion criteria: * iiib/c and iv stage of breast cancer * received neoadjuvant hormonal therapy or neoadjuvant chemotherapy * had first and second biopsy (surgery) within 6 months exclusion criteria: * had mastectomy before treatment * pregnant * disagree to enter the study * had been given hormonal therapy or chemotherapy before study * had contra-indication of sob for pre-menopausal patients