Kornimate/medical-research-clean huggingface dataset:
gingivitis reduction after use of 0.45% stannous fluoride toothpaste

Conditions: Gingivitis; Plaque, Dental

Summary: the 6-month clinical study was designed to investigate clinical efficacy on plaque and gingivitis for the stannous fluoride containing toothpaste (snap) compared to colgate cavity protection toothpaste after 3 and 6 months of product use.


Eligibility criteria:
inclusion criteria: * potential subjects must meet all of the following criteria * subjects, ages 18-70, inclusive * availability for the six-month duration of the clinical research study * good general health * initial gingivitis index of at least 1.0 as determined by the use of the loe-silness gingival index * initial plaque index of at least 1.5 as determined by the use of the quigley-hein plaque index * signed informed consent form exclusion criteria: * presence of orthodontic appliances * presence of partial removable dentures * tumor(s) of the soft or hard tissues of the oral cavity * moderate and/or advanced periodontal disease, rampant caries, or any condition that the dental examiner considers exclusionary from the study * five or more carious lesions requiring immediate restorative treatment * antibiotic use any time during the one-month period prior to entry into the study -participation in any other clinical study or test panel within the one month prior to entry into the study * dental prophylaxis during the past two weeks prior to baseline examinations * history of allergies to oral care/personal care consumer products or their ingredients -on any prescription medicines that might interfere with the study outcome * an existing medical condition that prohibits eating and/or drinking for periods up to 4 hours * history of alcohol and/or drug abuse * self-reported pregnancy and/or lactating subjects.

Keywords: loe and silness gingival index quigley and hein plaque index
reliability and validity of urdu version of boston carpal tunnel syndrome questionnaire

Conditions: Carpal Tunnel Syndrome

Summary: translate and culturally adapt boston carpal tunnel syndrome questionnaire into urdu language and find its reliability and validity in pakistani carpal tunnel syndrome patients to check its correlation with disabilities of the arm, shoulder and hand questionnaire and visual analog scale.

the original version of boston carpal tunnel syndrome questionnaire will be translated into urdu. among idiopathic carpal tunnel syndrome, 110 patients will be included in the study by convenience sampling. the selection of the patients will be done according to the criteria. boston carpal tunnel syndrome questionnaire will be correlated with disabilities of the arm, shoulder and hand questionnaire and visual analog scale and these questionnaires will be provided three times to a single patient for their assessment. firstly, they will be provided prior to treatment and secondly just after having treatment. thirdly, they will be given after seven days of treatment. internal consistency and reproducibility will be used to determine reliability. boston carpal tunnel syndrome questionnaire will be correlated with disabilities of the arm, shoulder and hand questionnaire and visual analog scale to assess validity. from each patient informed consent will be obtained. statistical package of social sciences software, version 24 will be used for the analysis of data.

Eligibility criteria:
inclusion criteria: * age equal to or above 18 years. * absence of any cognitive impairment. * patients having positive tinel and phalen test. exclusion criteria: presence of any of following conditions. * diabetes * polyneuropathy * hypothyroidsm * rheumatoid arthritis

Keywords: boston carpal tunnel questionnaire carpal tunnel syndrome cultural adaptation validity urdu version reliability
spinal cord injury virtual coach rct

Conditions: Spinal Cord Injuries

Summary: the sci virtual coach study has developed an on-screen, human-like character that will provide support, education and coaching to adults with spinal cord injury (sci) to aid in the prevention of serious secondary conditions like pressure ulcers. in a randomized controlled trial, participants assigned to "the coach" intervention will have a touch-screen computer placed in their homes and be asked to interact with the coach on a daily basis for 2 months. participants will be asked to complete surveys at baseline and 2 months. the sci virtual coach study aims to measure how accessible and usable participants feel the coach is, as well as participants' adherence to the coach's instructions. it will also gauge how effective the coach is in changing self-care knowledge, health care behaviors, self-efficacy for self-care, and perception of social support in participants.


Eligibility criteria:
inclusion criteria: * self-report of physician-confirmed chronic spinal cord injury diagnosis * injured within the last 6 months -10 years * speaks and understands conversational english * lives within approximately 1 hour of boston, ma exclusion criteria: * moderate to severe cognitive impairment * expected to live less than 1 year

Keywords: spinal cord injuries health behavior
to evaluate immunogenicity & safety of gsk bio's dtpa-hbv-ipv/hib (mixed vaccine) and dtpa-ipv/hib + hbv vaccines

Conditions: Hepatitis B

Summary: this study assessed the immunogenicity and safety of two vaccination regimens that employed either gsk biologicals' combined dtpa-hbv-ipv/hib vaccine or dtpa-ipv/hib vaccine. in the two groups, infants received the dtpa-ipv/hib vaccine at 3 and 4 months of age, as the first 2 doses of the primary vaccination course. at 5 months of age, they received either the dtpa-ipv/hib vaccine co-administered with the hbv vaccine or a dose of the dtpa-hbv-ipv/hib vaccine as a 3rd dose. infants in the two groups had previously received 2 doses of hbv vaccine at birth and at 1 month of age.


Eligibility criteria:
inclusion criteria: * a male or female infant at the age of 11 - 17 weeks. * written informed consent obtained from the parents or guardians of the subject. * free of obvious health problems as established by clinical examination before entering into the study. * hepatitis b vaccine at birth and one month of age. exclusion criteria: * previous vaccination against measles, mumps, rubella and/or varicella. * use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period. * a family history of congenital or hereditary immunodeficiency. * any confirmed or suspected immunosuppressive or immunodeficient condition, including hiv infection. * major congenital defects. * history of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
saferteens m-coach

Conditions: Alcohol Drinking; Violence

Summary: this study will use a smart (sequential, multiple assignment randomized trial) design to optimize adaptive interventions (ais) for adolescents reporting alcohol misuse and violent behaviors. the study will test the efficacy of state-of-the-art adaptive intervention delivery approaches (text messaging, remote therapy) for reducing alcohol use and violent behaviors among urban teens. given the morbidly/mortality associated with alcohol use and violence, this study will have significant impact by using a smart design to identify the optimal intervention strategy to produce and sustain outcomes among at-risk youth.

the specific aims are to: 1) compare the efficacy of adaptive interventions (ais) that begin with bi+tm (brief intervention + text messaging) vs. bi+hc (brief intervention + remote health coach) on reducing alcohol misuse and violent behaviors among youth while in the emergency department (ed); and, 2) identify the most efficacious second-stage strategy post-ed visit for those who initially respond and for those who do not. specifically, 700 youth (ages 14-20) in the ed screening positive for alcohol use and violent behaviors will be randomly assigned to: bi+tm or bi+hc. after receiving the saferteens bi in the ed, youth will complete weekly assessments over an 8 week period to tailor intervention content and measure mechanisms of change, with one month determination of participant response (e.g., binge drinking, violence). responders in each arm will be re-randomized to continued condition (e.g., stay the course or maintenance), or reduced condition (e.g., stepped down). non-responders will be re-randomized to continued condition (e.g., stay the course or maintenance), or intensified condition (e.g., stepped up). follow-up assessments will take place at 4 and 8 months post-baseline.

Eligibility criteria:
inclusion criteria: * patients age 14-20 years presenting to the ed for any reason(except exclusions as noted below) * past 4 month binge alcohol use and violent behaviors (i.e., physical aggression) * have a cell phone with texting capabilities and a cell phone plan for texting exclusion criteria: * patients who do not understand english * patients deemed unable to provide informed consent due to mental incompetence, incarceration, or medically unstable (abnormal vital signs requiring urgent resuscitation) or * present for acute suicidal ideation or acute suicide attempt, child abuse, or sexual assault
trial of befizal® 200 mg for the treatment of leber hereditary optic neuropathy

Conditions: Safety Issues; Efficacy, Self

Summary: study of the efficiency of béfizal® 200 mg in 14 adult patients with a lhon that occurred for less than 5 years. patient must have certain specific mutations

study of the efficiency of béfizal® 200 mg in 14 adult patients in whom the diagnosis of lhon obtained on anamnestic, clinical and ancillary testing / laboratory data. lhon should have occurred for less than 5 years and must be genetically proved with a 3460 or 11778 mitochondrial dna mutation. given the mode of transmission, genetic research may have been carried out in a maternal relative

Eligibility criteria:
inclusion criteria: * adult patients in whom the diagnosis of lhon obtained on anamnestic, clinical and ancillary testing / laboratory data. lhon should have occurred for less than 5 years and must be genetically proved with a 3460 or 11778 mitochondrial dna mutation. given the mode of transmission, genetic research may have been carried out in a maternal relative exclusion criteria: * \* any optic neuropathy for which the diagnosis of lhon is not formally confirmed or genetically proven; * lhon that started for more than 5 years; * lhon associated with another primary mutation than 3460 or 11778 * children or adult patients under guardianship or deprived of liberty by administrative or judicial decision; * women of childbearing age ; pregnant or lactating women; * patients who do not have affiliation to a social protection scheme (national or private insurance / beneficiary or assignee); * patient who did not give its written, informed and signed consent; * allergy to fibrate, bezafibrate and / or befizal® 200mg (arrow generiques) or one of these constituents; * photosensitivity reactions related to fibrates; * patient already receiving treatment with fibrates or hmg co-a reductase inhibitors or anticoagulants; * hepatic insuffisiency or dysfunction with increased of transaminases (ast and alt) over 3 times of the normal; * renal insufficiency with serum creatinine\> 15 mg / l (\> 135 mg / dl) biliary pathology

Keywords: leber herediatry optic neuropathy befizal
open versus endoscopic surgical management of posterior calcaneal deformity.

Conditions: Bone Diseases

Summary: patients with posterior calcaneal deformity may presented by many clinical data associated with retrocalcaneal bursitis which occurs due to the deformity this clinical complaining include pain and swelling in the back of the heel. many treatment choices available of this deformity with low level of response to conservative treatment which includes medical treatment , physiotherapy and corticosteroids injection. surgical treatment in cases of haglund deformity is the treatment of choice including either endoscopic or open surgical approach for this deformity .


Eligibility criteria:
inclusion criteria: * symptomatic patients. * continued refractory pain despite use of extensive conservative management. exclusion criteria: * asymptomatic patients * patients which are unfit for surgery.
the clinical effect of tcm sniffing therapy combined with electroacupuncture in psci

Conditions: Stroke

Summary: the patients with cognitive impairment after stroke were divided into control group, electroacupuncture group, olfactory therapy group, electroacupuncture combined with olfactory therapy group, and sham group with 35 people in each group. after the end of the treatment, the clinical efficacy was evaluated.

the patients with cognitive impairment after stroke were divided into control group, electroacupuncture group, olfactory therapy group, and electroacupuncture combined with olfactory therapy group, and sham group with 35 people in each group. all patients were treated with conventional drugs and general supportive treatment, and on the basis of this, the electroacupuncture group was given electroacupuncture treatment at bilateral fengchi and gongxue, the smell suction therapy group was given the intervention of volatile oil nasal suction of acorus calamus, and the electroacupuncture group combined with smell and suction therapy group was given electroacupuncture treatment at the same time as the electroacupuncture treatment of bilateral fengchi and gongxue. in the sham stimulation group, non-transdermal comfortable acupuncture will be used to make the patients experience a feeling similar to acupuncture. after the 1 month innervation,the main efficacy indicators: mini-mental state examination (mmse), montreal cognitive assessment (moca), barthel index (mbi) score, and the secondary efficacy indicators: transcranial doppler (tcd), near-infrared functional brain imaging , magnetic resonance examination， the heart rate,blood pressure and the state trait anxiety inventory （stai）are collected.

Eligibility criteria:
inclusion criteria: * (1) stroke as per the tcm definition, presenting symptoms include unilateral paresis or paralysis, sensory deficits, speech impairment, and hemianopsia. psci diagnosis involves clinically significant deficits in at least one cognitive domain and severe disruption of instrumental adls/adls.; (2) the scores on the mmse scale must adhere to the following criteria: less than 17 points for individuals with illiteracy, less than 20 points for those with primary school education, and less than 24 points for individuals with a middle school education or higher.; (3) aged under 70 years; (4) no history of mental illness, clear consciousness, stable vital signs, and able to complete the scale assessment; (5) within 6 months post-stroke, diagnosed as a patient in the recovery period of cerebral infarction (or cerebral hemorrhage) at admission; (6) signed informed consent by the patient or their family. exclusion criteria: * (1) transient ischemic attack; (2) subarachnoid hemorrhage; (3) history of severe liver or kidney diseases, mental illness, epilepsy, asthma, or obstructive pulmonary diseases; (4) occurrence of cognitive impairment prior to stroke; (5) severe communication barriers; (6) substance abuse or heavy alcohol consumption; (7) implanted cardiac pacemakers or other electronic devices.
evaluation of implant fixation in reverse total shoulder arthroplasty

Conditions: Arthritis

Summary: reverse total shoulder replacement surgery (rtsa) is performed for individuals with advanced arthritis of the shoulder who also have tears in their rotator cuff muscles. a metal hemisphere is placed in the shoulder blade, and a plastic cup on a stem is placed in the upper arm. this orientation is opposite to the normal anatomy, giving rise to the term "reverse" shoulder replacement. while rtsa has a good clinical track record, no studies have examined how well fixed the implanted components are within patients.


Eligibility criteria:
inclusion criteria: * will be any patient with cuff tear arthropathy requiring reverse shoulder arthroplasty. exclusion criteria: * will be any patient with a previous rtsa or tsa (i.e. no revision surgery) or anyone unable to return for rsa imaging (e.g. living \>100 km outside of london).

Keywords: advanced arthritis shoulder
gastric content after 6 vs 4 hours of preoperative fasting in children

Conditions: Pulmonary Aspiration of Gastric Contents

Summary: the primary objective of the study is to compare the risk of increased stomach contents after tube feeding (enteral feeding) 6 and 4 hours before anesthesia using antrum measured by ultrasound.

children must fast for a certain period of time before anesthesia and surgery to reduce the risk of food residues being vomited up and ending up in the trachea (so-called aspiration). but there are disadvantages to fasting for a long time before an operation, for example the blood sugar level can drop and the body can become dehydrated. small children risk such side effects to a greater degree than adults, and therefore international work is underway to revise the rules for fasting before surgery. enteral feeding children are a special risk group because they are usually completely dependent on tube feeding for nutrition and fluid intake.

Eligibility criteria:
inclusion criteria: child on intermittent or continuous enteral nutrition, scheduled for elective procedure requiring general anesthesia exclusion criteria: moderate to severe gastrointestinal motility disorder emergency surgery anatomical risk factor for pulmonary aspiration such as achalasia or bowel obstruction parents cannot understand study information due to language barrier

Keywords: preoperation fasting anaesthesia children enteral feeding
dynamic individualized rtms based on fnirs

Conditions: Stroke; Rehabilitation; Repetitive Transcranial Magnetic Stimulation; Functional Near-infrared Spectroscopy

Summary: stroke patients do not respond well to the traditional repetitive transcranial magnetic stimulation (rtms) strategy based on the competitive model. the studies found that the contralesional motion cortex has a compensatory effect on the realization of the motor function of the affected side-the compensatory model, and the degree of compensation will change as the function changes. the optimal neural regulation strategies under different models are opposite, so it is important to accurately evaluate which of the two models plays the leading role. and functional near-infrared spectroscopy (fnirs) may accurately and quickly assess cortical function in order to determine the degree of participation of the contralesional motion cortex. we propose that the dynamic individualized strategy which adjust the rtms parameters promptly based on the results of fnirs will be better than the traditional stimulation strategy. this project will apply a blinded-assessment randomized controlled trial. the test group selects either the high-frequency rtms to the contralesional dorsal premotor cortex (pmd) or the low-frequency rtms to the contralesional primary motor cortex (m1) based on the lateralization index of the pmd measured by fnirs. and the control group will always be given low-frequency rtms to contralesional m1. the difference in the improvement of upper limb function between the two groups of patients was compared.


Eligibility criteria:
inclusion criteria: * aged 40-79 years; * patients with first-onset subcortical infarcts within1 to 3 weeks after onset; * tms on the lesion side can induce motor evoked potential(mep) of the abductor pollicis brevis muscle of the affected hand; * consciousness, sitting balance level 1 or above, can cooperate with assessment and treatment; * the patient or its authorized agent signs the informed consent form. exclusion criteria: * previous seizures; * suffered from mental illness such as depression, anxiety, mania, and schizophrenia before the stroke onset; * patients with metal on the head, cochlear implants, intracranial infections, etc. who are not suitable for rtms.
tolerability and efficacy of instylan in subjects with moderate to severe hemorrhagic cystitis

Conditions: Hemorrhagic Cystitis

Summary: the purpose of this study is to assess the efficacy and tolerability of instylan (sodium hyaluronate 80mg/50ml) in patients with early or late symptoms of moderate to severe hemorrhagic cystitis caused by pelvic radiation therapy and/or chemotherapy. the study is conducted in the field of routine clinical practice and will recruit 30 subjects treated with intravesical instillations with instylan weekly for 6 weeks.

this is a multicenter single-arm clinical study including male and female subjects with moderate to severe hemorrhagic cystitis caused by pelvic radiation therapy and/or chemotherapy as determined by the physician. a total of 30 subjects are anticipated and will be enrolled in 10 study sites in france. the patients will receive intravesical instillations with instylan weekly for 6 weeks. the objectives of the study are to assess the efficacy of intravesical instillations of instylan on the basis of hemorrhagic cystitis symptoms disappearance. the primary endpoint is the evaluation of pain using a verbal rating scale one week and four weeks after treatment versus baseline.

Eligibility criteria:
inclusion criteria: * males and females, at least 18 years, * patients who provided signed written informed consent, which includes compliance with requirements listed in the consent form, * patients with diagnosis of hemorrhagic cystitis, * patients with diagnosis of bladder pain (pressure or pelvic discomfort) with at least one other urinary symptom (need to urinate right away (urgency), often (frequency), or both). exclusion criteria: * patients with post-void residual (pvr) urine volume \> 200ml, * patients presently treated with intravesical treatment (replenishment therapy with glycosaminoglycans), * patients receiving hyperbaric oxygen therapy (hbot), * patients with neurogenic bladder, * patients treated with neuromodulation techniques within the last six months, * patients undergoing or scheduled for radiation therapy, brachytherapy, chemotherapy or treatment with bcg or with mitomycin-c, * patients suffering from lower urinary infections (utis), * patients with unstable cardiovascular disease, * patients with any other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.

Keywords: hemorrhagic cystitis