Kornimate/medical-research-clean huggingface dataset:
pilot study for evaluation of the need for protective ileostomy after low anterior resection due to rectal cancer

Conditions: Rectal Cancer

Summary: the purpose of this study is to determine whether protective ileostomy is required after low anterior resection due to rectal cancer

since introduction of total mesorectal excision prognosis and quality of life of patients with rectal cancer of the middle or lower third of the rectum could be improved significantly. there is no valid data about the need of protective ileostomy in these patients. about 10% of the patients develop insufficiency of the anastomosis and might benefit from ileostomy whereas about 90% would not have required protective ileostomy retrospectively. aim of the study is to show that protective ileostomy is not required if several criteria are fulfilled and early measures in case of clinical impairment are defined. therefore eligibility criteria include safely performed stapler anastomosis with complete rings and control of impermeability by air insufflation. in the event of clinical impairment in the postoperative course ct scan with km filling of the rectum to exclude insufficiency of the anastomosis will be performed. in case of insufficiency protective ileostomy will be created. 40 patients will be included. comparison: patients with resectable rectal cancer of the middle or lower third will be intraoperatively randomized to either protective ileostomy or no ileostomy at all.

Eligibility criteria:
inclusion criteria: * radical resectable rectal cancer * low sphincter-preserving resection of carcinomas of the lower and middle third * preoperative normal continence * preoperative normal sphincter function * complete rings after stapler anastomosis * impermeability of anastomosis for air * written informed consent exclusion criteria: * reduced cooperation or drug abuse * pregnancy * psychosis * age under 18 years

Keywords: protective ileostomy rectal cancer low anterior resection
desensitizing efficacy of polymeric nano calcium fluoride containing varnish

Conditions: Dentin Hypersensitivity

Summary: the aim of this study is to evaluate the desensitizing efficacy of polymeric nano calcium fluoride containing varnish and its implementation into clinical practice.

increasing the demand to find a desensitizing agent that should be biocompatible, easy to apply, painless, not changing the dental color, fast onset, and maintain a long-term effect gives a highlight to the patented formula of the polymeric nano calcium fluoride which newly introduced into the practice . olinano seal is an innovative "varnish-like" protector based on a patented silicone polymer with a true nano technology that provides an exceptional adhesion to enamel and dentin without prior etching for approximately 12 months (other available products max. 2-3 months). it consists of four components silicone polymer provides excellent adhesion to enamel and dentine, with transparent formula. nano-fluoroapatite flows into enamel micro cracks \& seals it, penetrating into the dentinal tubules closing them eventually. as for the nano-calcium fluoride it behaves as a fluoride reservoir, provides gradual and long-term fluoride release. the fourth component amine fluoride (olaflur) provides immediate fluoride ion release and accelerates natural remineralization.

Eligibility criteria:
inclusion criteria: * patients with good oral hygiene. * the age range of 18-65 years. * patients from both gender. * patients suffering from pain due to dentin hypersensitivity. * hypersensitive areas on facial surfaces of the teeth (incisors, cuspids, bicuspids, and first molars with exposed cervical dentine). * non carious cervical lesions: abrasion,erosion, abfraction, and recession with cervical dentin exposure exclusion criteria: * patient with bad oral hygiene. * patients with constant use of analgesic, antihistaminic, anticonvulsive, sedative, tranquilizing, or anti-inflammatory medications 72 hours before treatment and pain assessment. * patients having received any desensitizing treatment during the last 3 months. * patients with allergy of any materials will be used in the study . teeth with pulpitis. * teeth with periodontal disease installed. * teeth exhibiting mobility (grade 2 or 3). * carious lesions, fractured teeth, defective restorations or prosthesis. * patients with orthodontics appliance.

Keywords: dentin sensitivity ,nano calcium fluoride, nano fluorapatite,casein phosphopeptide amorphous calcium phosphate.
brain stimulation and group therapy to improve gesture and social skills in psychosis (bragg-sos)

Conditions: Schizophrenia

Summary: randomized, double-blind, placebo-controlled clinical trial testing the effects of 10 sessions of continuous theta burst stimulation and the effects of 16 sessions of social cognitive remediation therapy on gesture performance and nonverbal communication skills in schizophrenia

the study focuses on nonverbal communication skills in schizophrenia. the trial will test, whether the combination of noninvasive brain stimulation and group psychotherapy will improve gesture performance and thus nonverbal communication in schizophrenia

Eligibility criteria:
inclusion criteria: * right-handed subjects * ability and willingness to participate in the study * ability to provide written informed consent * informed consent as documented by signature * schizophrenia spectrum disorders according to diagnostic and statistical manual version 5 (dsm-5) exclusion criteria: * substance abuse or dependence other than nicotine * past or current medical or neurological condition associated with impaired or aberrant movement, such as brain tumors, stroke, m. parkinson, m. huntington, dystonia, or severe head trauma with subsequent loss of consciousness. * epilepsy or other convulsions * history of any hearing problems or ringing in the ears * standard exclusion criteria for cerebral magnetic resonance imaging scanning and transcranial magnetic stimulation (tms); e.g. metal implants, claustrophobia * patients only: any transcranial magnetic stimulation (tms) treatment in the past 3 months * patients only: any cognitive remediation therapy in the past 2 years * women who are pregnant or breast feeding, * intention to become pregnant during the course of the study, * female participants who are surgically sterilised / hysterectomised or post-menopausal for longer than 2 years are not considered as being of child bearing potential. * previous enrolment into the current study, * enrolment of the investigator, his/her family members, employees and other dependent persons

Keywords: gesture rtms cognitive remediation social cognitive remediation therapy
effects of spirulina supplementation on overweight or obese adults

Conditions: Obesity

Summary: in this double-blind randomized controlled clinical trial investigators are going to study the effects of spirulina supplementation on anthropometric measurements, lipid profile, appetite, liver enzymes, inflammatory and glycemic markers in a sample of overweight or obese adults.

a sample of 40 obese and overweight subjects will be recruited from nutrition and diet therapy clinic of shahid beheshti medical university. this study is a double-blind randomized controlled clinical trial, that subjects will be randomly allocated to spirulina or placebo group according to the random permuted blocks within strata method based on bmi. subjects will consume 2 g spirulina daily (4 tablets of 500mg), whereas the control group are going to receive identical placebo tablets. subjects are asked to maintain their usual physical activity level during the intervention period and also avoid taking any other supplements or medications without consulting the investigators. intervention period is designed to be 12 weeks that has been determined sufficient to record changes of study parameters. at the beginning of the study and after 12 weeks of intervention, morning blood samples will be collected after 12 h of fasting. anthropometric parameters will be also measured at the beginning, week 6 and after 12 weeks of intervention. subjects will be followed through social network to ensure their compliance with the study. furthermore, subjects in both spirulina and placebo groups received low calorie diet (-500 or -300 kcal) composed of 55% carbohydrate, 15% protein and 30% fat during the study period.

Eligibility criteria:
inclusion criteria: * bmi\>25 kg/m2 * no history of medications for obesity, diabetes, dyslipidemia, inflammatory disease within 3 months before the study * no history of vitamin or antioxidant supplementation within 3 months before the study * giving written informed consent for participation exclusion criteria: * having chronic kidney or hepatic disease except nafld * havig hypo or hyperthyroidism * having autoimmune and infectious disease * weight reduction diet therapy within 6 month from the intervention * having more than 3kg weight change in recent 2 months * having recent surgery * taking anticoagulant drugs

Keywords: obesity bmi body weight
minimal invasive rehabilitation of tooth loss in the anterior segment

Conditions: Unsatisfactory or Defective Restoration of Tooth

Summary: tooth loss can be addressed by different rehabilitative strategies. implant-supported crowns and conventional bridges (fixed dental prostheses \[fdps\]) are well established treatment alternatives. implant therapy is sometimes impossible, however, because of patient-related risk factors or economic issues. in such cases therapy with an fdp requires extensive removal of tooth structure to provide enough space for the restoration and to ensure mechanical retention if the abutment teeth are sound. alternatives for rehabilitation requiring minor or no preparation of the anchoring teeth are desirable. resin-bonded bridges meet this demand for minimal invasiveness and have been used clinically successfully. sometimes, however, patients choose a conventional fdp over a resin-bonded one (rbfdp) for esthetic reasons since the adhesive wings, which are traditionally made of a cobalt-chromium alloy, might be exposed while speaking or smiling or account for a colour change of the abutment teeth. such patients profit from an all-ceramic rbfdp. today, the clinical performance of metal-based and all-ceramic rbfdps has not yet been evaluated under randomized controlled conditions. the aim of this pilot study is to calculate the sample size that allows us to accept the hypothesis that metal- and all-ceramic rbfdps are similar regarding their clinical performance with adequate statistical power.


Eligibility criteria:
inclusion criteria: * missing central or lateral incisor * regular patient of the department of prosthodontics of the university hospital of heidelberg * willingness to return for recall examinations on a regular basis * written informed consent * abutment teeth are vital or sufficiently endodontically treated * abutment teeth are periodontally stable * abutment teeth have only little or no defects of the hardsubstances exclusion criteria: * pregnancy or breastfeeding * medically compromised condition not allowing for standard dental treatment * patient is not able to give written informed consent * alcohol or drug abuse * positive bruxism and parafunctions questionaire * bite-strip \> 2 * attrition score \> 3 * deep bite (angle class ii/2) * abutment tooth height \< 4mm * untreated symptomatic periodontal or endodontic lesions * abutment tooth mobility \> grade i * known allergies to materials used in this study * poor dental hygiene * planned change of residency
effect of nva237 on exercise endurance in patients with chronic obstructive pulmonary disease (copd)

Conditions: Chronic Obstructive Pulmonary Disease

Summary: the ability for patients with copd to exercise is limited due to the deterioration of their lung function. nva237 is being developed to treat copd. this study is designed to look at how well nva237 improves the ability to exercise in patients with moderate to severe copd.


Eligibility criteria:
inclusion criteria: * patients who signed an informed consent form prior to initiation of any study-related procedure * patients with moderate to severe stable copd (clinical diagnosis in compliance with gold 2008) * current or ex-smokers with a smoking history ≥ 10 pack years. (ten pack-years were defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years etc.). * patients with a post-bronchodilator fev1 ≥ 40 and \< 70% of the predicted normal, and postbronchodilator fev1/fvc \< 0.7 during screening. (post referred to the highest post-bronchodilator value after inhalation of 80 μg ipratropium bromide) * increase in fev1 from pre- to post-bronchodilator assessment of ≥ 5% exclusion criteria: * pregnant women or nursing mothers * women of child-bearing potential * patients who had a copd exacerbation (whether hospitalized or not) in the 6 weeks prior to visit 1 or between visit 1 and visit 4 * patients who had a lower respiratory tract infection in the 6 weeks prior to visit 1 * patients requiring long term oxygen therapy on a daily basis for chronic hypoxemia * patients with resting (5 min) oxygen sao2 (or spo2) saturation on room air of \< 85% * patients with a maximum workload (wmax) value \< 20 w (as determined by the incremental cycle endurance test) at visit 2. * patients whose exercise endurance time at sub-maximal workload was above 25 min at baseline * patients with a clinically significant abnormality on the screening or baseline ecg who in the judgment of the investigator would have been at potential risk if enrolled into the study * patients with a history of long qt syndrome or whose qtc was prolonged (\> 450 ms for males and \> 470 ms females) at screening (fredericia's correction) other protocol-defined inclusion/exclusion criteria applied

Keywords: nva237 copd bronchodilator exercise endurance
constructive variations of classic orthopedic braces for spinal deformity during growth

Conditions: Scoliosis

Summary: the construction methods of the same brace vary on an experiential basis according to who builds them, the prescriber, the characteristics of the patients and also the innovations introduced to ensure greater comfort for the patient. the closure of the brace or the way in which the two shells are fixed varies at the discretion of the orthopedic technician. plastic materials have also changed. in addition, the use of the classic cast for the production of the negative model was gradually replaced by cad-cam technology. in some cases, modular constructions were introduced with respect to the customized one. all this has changed the classic corsets over time, even without changing their name / type, and according to the hypothesis that their effectiveness remained at least the same, if not even improved. there are no publications that have shown variations in efficacy that can be correlated with some of these stylistic variations. the purpose of this study is to retrospectively investigate whether the various innovations and stylistic variations over time have had an effect on the clinical, functional and radiographic outcomes in growing subjects suffering from spinal deformity treated with corsets at a specialized center.


Eligibility criteria:
inclusion criteria: * idiopathic adolescent scoliosis and/or dorsal hyperkyphosis, * age under 16 years at the start of observation, * brace prescription for more than 18 hours/day, * availability of radiographs of the entire spine while standing and in brace radiographs at 1 month or out of brace at 5 ± 2 months at the end growth after 48 hours without brace and at 1 year. * availability of compliance data * risser between 0 and 4 at first assessment exclusion criteria: * all secondary causes of scoliosis * history of spinal fusion surgery * lack of one of the radiographic examinations required by the protocol
platelet-rich fibrin with 1.2% rosuvastatin in chronic periodontitis treatment

Conditions: Chronic Periodontitis

Summary: the present study is designed to evaluate the combined efficacy of platelet rich fibrin (prf) and 1.2% rosuvastatin (rsv) with open flap debridement (ofd) in treatment of intrabony defects in chronic periodontitis patients

abstract background: regenerative periodontal therapy encompasses the use of various bioactive agents that are not only inflammo-modulatory but also osteoclast-inhibitory or rather, osteostimulative. the hypolipidaemic statin group of drugs, particularly rosuvastatin (rsv), are known to be associated with alveolar bone formation and periodontal improvements. platelet analogues like platelet rich fibrin (prf), being rich sources of growth factors, have also come into widespread periodontal regenerative use. the aim of the study is to evaluate and compare the efficacy of open-ﬂap debridement (ofd) with or without prf or prf + 1.2% rsv gel in the treatment of intrabony defects (ibds) in chronic periodontitis (cp) patients. methods: ninety individuals with a total of 90 ibds were randomly assigned to one of the 3 treatment groups: 1) ofd alone, 2) ofd + prf and 3) ofd + prf + 1.2% rsv gel placement. plaque index (pi), modified sulcus bleeding index (msbi), probing depth (pd), clinical attachment (ca) level and ibd depth were recorded at baseline and at 9 months post-operatively.

Eligibility criteria:
inclusion criteria: * systemically healthy with cp diagnosis16 having probing depth (pd) ≥5mm, clinical attachment (ca) level ≥3mm and vertical bone loss ≥3mm on intraoral periapical radiographs (iopar) without any antibiotic or periodontal therapy in the last 6 months. exclusion criteria: * history of statin allergy, statin therapy, any systemic condition or medication altering the periodontal condition, immune-compromised state, hematologic disorders, insufﬁcient platelet count (\<200,000/mm3), aggressive periodontitis, substance/tobacco abuse and lactating and pregnant females.
resilient together for dementia (rt-d)

Conditions: Dementia

Summary: this study will evaluate the feasibility and preliminary efficacy of the novel resilient together for dementia (rt-d) intervention for couples following dementia diagnoses. the primary target is emotional distress, and the program aims to prevent chronic distress in at-risk couples.

both persons living with dementia and their spousal care-partners experience high levels of clinically elevated emotional distress, which can become chronic without treatment and negatively impact the health, quality of life, communication, and care-planning of both partners. a tailored dyadic intervention, such as the proposed resilient together for dementia, delivered over live video to this at risk population has the potential to prevent chronic emotional distress and preserve quality of life for pwds and their loved ones. a pilot feasibility randomized control trial (rct; aim 3; nia stage 1b; n=50 dyads) will be conducted of the refined rt-d versus a minimally enhanced educational control (meuc, educational pamphlet). primary outcomes will be feasibility, credibility, and acceptability markers to inform a hybrid efficacy effectiveness r01 (year 4) of rt-d vs. meuc (nia stage ii). in this subsequent r01, the researcher will examine rt-d's impact on emotional distress and quality of life outcomes and test mechanisms of change (individual and interpersonal resiliency skills) through mediation and moderation. the researcher will revise the approach if feasibility benchmarks are not met.

Eligibility criteria:
inclusion criteria: * recent (\~3 month) chart documented adrd diagnosis, * adrd symptom onset after age 65 * cognitive assessment scores and symptoms consistent with early stage dementia, as determined by the clinical dementia rating scale scores of .5 or 1.0 * cognitive awareness of their problems (as determined by the treating neurologist), and ability to understand study and research protocol, as determined by a standardized teach-back method assessment additional inclusion criteria for dyads are: * english speaking adults (18 years or older) * dyad lives together * at least one partner endorses clinically significant emotional distress during screening (\>7 on hospital anxiety and depression scale subscales or \<5 on the geriatric depression scale) exclusion criteria: * patient is deemed inappropriate by the neurology team * either partner has a co-occurring terminal illness * patient was diagnosed with forms of dementia with clinical profiles that would preclude participation (e.g., frontotemporal dementia- behavioral variant), as determined by treatment team.

Keywords: dementia care partners dyads emotional distress quality of life couples
scapular dyskinesis: a reliability and validity study of comprehensive classification test

Conditions: Unilateral Shoulder Pain With and Without Scapular Dyskinesis

Summary: study design: clinical measurement (cross-sectional) objectives: the purpose of this study was to investigate the reliability and validity of the novel scapular dyskinesis classification test. background: a visual-based clinical assessment with sufficient reliability and validity to identify scapular dyskinesis provides information for rehabilitation treatment. methods: a visual-based palpation method was evaluated by two independent physiotherapists in 60 subjects with unilateral shoulder pain to test reliability. this method classified the scapular movements during arm raising/lowing movements in scapular plane as single abnormal scapular patterns (inferior angle/ medial border/ superior border of scapula prominence and abnormal scapulohumeral rhythm) or mixed abnormal scapular patterns. different patterns of scapular dyskinesis were also validated by corresponding alternation of the scapular kinematics and muscular activities assessed by electromagnetic motion-capturing system and surface electromyography (emg).

no other detailed description

Eligibility criteria:
inclusion criteria: * (1) they were from 18 to 50 years old and (2) they had unilateral shoulder pain around shoulder complex during activities. exclusion criteria: * history of shoulder dislocation, fracture, or shoulder surgery within past 1 year, or a history of direct contact injury to the neck if upper extremities within the past 1 month, scoliosis or excessive kyphosis, neurological disorders, body mass index (bmi)≧25, or demonstrate pain (vas\>3) during overall testing procedure.

Keywords: scapular dyskinesis, kinematics, muscular activities