Kornimate/medical-research-clean huggingface dataset:
additive effects of dental bite pads during gymnastic exercises for the relief of chronic non-specific neck pain in working women and men at a vdu workplace

Conditions: Chronic Neck Pain; TMD; Temporomandibular Dysfunction

Summary: the study which includes 52 participants suffering from chronic neck pain, determines additional effects of dental bite pads on neck pain and function when performing a 3-month gymnastics programme.

chronic neck pain is a common health problem in our society. targeted gymnastic exercises have a high priority in the context of therapy and have shown positive effects on the symptoms in studies. in the past, direct connections between the temporomandibular joint and complaints of the musculoskeletal system, especially of the shoulder-neck region, have been researched, which are based on neuroanatomical (nerves) and myofascial (muscle-fascia) connections. against the background of current study results, consideration of these findings could be promising in the therapy of neck pain. a new approach tries to positively influence tension and discomfort in the neck area by changing the position of the temporomandibular joints using dental bite pads. in the planned study, the researchers are specifically investigating the question of the extent to which the placement of dental bite pads (made of silicone) in the molar region during the performance of gymnastic exercises can increase the effect of the exercises on neck pain and the associated restrictions on function and quality of life. the aim of the present project is specifically to record the effect of a 3-month gymnastics programme and a possible additional effect of dental bite pads. in the study, 52 working women and men with a sedentary job at a computer workstation aged 30-65 years are included and randomly divided into two groups. both groups will perform a specific video-animated exercise programme for 3 minutes 3 times a day over a period of 3 months with the main focus on the shoulder-neck region. one group positions a silicone dental bite pad (tj motion; bely balance gmbh \& co. kg, weisendorf, germany) on the right and left side of the molar region during the exercise. before the intervention, after 6 weeks and after a further 6 weeks of follow-up, pain and function in the neck area are assessed by questionnaire. at baseline and follow-up, functional tests of spinal and jaw mobility are also performed.

Eligibility criteria:
inclusion criteria: * men and women 30-65 lj * chronic non-specific neck pain \[4\] (at least for 3 months, pain intensity ≥2 (nrs) on at least 50% of days). * sedentary work, vdu work exclusion criteria: * specific neck pain (e.g. herniated disc, spinal stenosis, etc.) * cervical spine-related neuronal symptoms (paresthesia, brachialgia, paresis) * continuous pain medication * concurrent other therapy to influence neck pain * absence ≥ 2 weeks during the intervention period * regular sports training (≥ 60min/week) in the last 6 months

Keywords: gymnastic dental bite pad
efficacy and safety of kn026 in combination with hb1801 in the first-line treatment of subjects with her2-positive recurrent or metastatic breast cancer.

Conditions: First-line Treatment of HER2-positive Recurrent or Metastatic Breast Cancer

Summary: this is a randomized, controlled, open-label, multicenter, phase ш clinical study designed to compare the efficacy and safety of kn026 in combination with hb1801 to trastuzumab in combination with pertuzumab and docetaxel in the first-line treatment of subjects with her2-positive recurrent or metastatic breast cancer. the statistical assumption for this study is superiority. the primary study endpoint was pfs as assessed by blinded independ review committee (birc).

the purpose of this study is to assess the efficacy and safety of kn026 combined with hb1801 versus trastuzumab combined with pertuzumab and docetaxel as first-line treatment for her2-positive recurrent or metastatic breast cancer. this study will establish an independent data monitoring committee (idmc) to conduct safety assessments after approximately 20 subjects in the treatment group complete the first cycle of treatment. during the safety assessment period, the study will continue to enroll subjects, and safety review meetings will be at 1 year of randomization in the first subject. in addition, the idmc plans to conduct one interim analysis of efficacy during the study period. the primary study hypotheses are that the combination of kn026 combined with hb1801 is superior to trastuzumab combined with pertuzumab and docetaxel with respect to: progression-free survival (pfs) as assessed by the birc per response evaluation criteria in solid tumors (recist 1.1).

Eligibility criteria:
key inclusion criteria: * voluntarily enrolled in this study and signed an informed consent form (icf). * age ≥ 18 years. * recurrent or metastatic breast cancer confirmed by histology and/or cytology. * latest tumor tissue sample confirmed as her2 positive by central laboratory testing. * no prior systemic chemotherapy and/or her2-targeted therapy for recurrent or metastatic breast cancer. * eastern cooperative oncology group (ecog) physical status score of 0 - 1. * presence of lesion (recist 1.1). * adequate organ and bone marrow function key exclusion criteria: * ineligible for any of the agents on the study * untreated or unstable parenchymal metastases, spinal cord metastases or compression, or carcinomatous encephalitis. * pregnant or lactating women. * presence of other circumstances that may interfere with the subject's participation in the study procedures or are inconsistent with the maximum benefit of the subject's participation in the study or affect the results of the study: e.g., history of mental illness, drug or substance abuse, any other disease or condition of clinical significance, etc.
first in human study in healthy volunteers followed with dosing in participants with lung or liver fibrosis

Conditions: Fibrosis

Summary: first in human single ascending dose followed by multiple ascending doses in healthy volunteers.


Eligibility criteria:
inclusion criteria: * able to provide written informed consent * agree to no smoking or alcohol or illegal substance 48 hours prior to dosing * have a negative urine drug screen/alcohol breath test on admission to clinic * agree to use highly effective, double barrier contraception (both male and female partners) during the study and for 30 days following completion of dosing * females of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test on day -1 * normal bmi except liver fibrosis participants (bmi 18 to ≤35 kg/m2) * be in general good health * clinical laboratory values within normal range * lung fibrosis participants-a diagnosis of lung fibrosis, * liver fibrosis participants-a diagnosis of liver fibrosis; some abnormal laboratory values will be acceptable for the following; platelet count, albumin, serum creatinine and neutrophil-leukocyte ration exclusion criteria: * presence of any underlying physical or psychological medical condition that, in the opinion of the investigator, would make it unlikely that the subject will complete the study per protocol * history or presence of alcoholism or drug abuse within the 2 years prior to the first study drug administration, and unwillingness to be totally abstinent during the dosing period * blood donation or significant blood loss within 60 days prior to the first study drug administration * plasma donation within 7 days prior to the first study drug administration * administration of investigational product (ip) in another trial within 30 days prior to the first study drug administration, or five half-lives, whichever is longer * females who are pregnant or lactating * surgery within the past 3 months prior to the first study drug administration determined by the pi to be clinically relevant * failure to satisfy the pi of fitness to participate for any other reason * active infection or history of recurrent infections * active malignancy and history of malignancy in the past 5 years, with the exception of completely excised basal cell carcinoma or low grade cervical intraepithelial neoplasia * chronic obstructive pulmonary disease * antibiotic treatment within 3 months * chronic medical condition
mi band step challenge to improve body composition in overweight university students

Conditions: Intervention Study; Physical Activity

Summary: this is an eight-month research project using one group pretest-midst-posttest design. this study is based on self-efficacy and self-regulation of social cognitive theory. the investigators will recruit 50 university students with a body mass index of 24 kg/m2 or above at one university campus. participation is completely voluntary. after pretesting, a 12-week "mi band step challenge" will be launched immediately. participants will be assessed with the validated instruments of international physical activity questionnaire (ipaq)-taiwan short-form, sedentary behavior questionnaire (sbq), self-efficacy and self-regulation questionnaires. mi band activity trackers will be used to monitor step counts. an ioi 353 body composition analyzer will be used to assess body composition. data will be analyzed using generalized estimating equation (gee). the expected outcomes of this study include: (1) "mi band step challenge" will be developed based on the theory, which is expected to be effective. if this is true, the intervention can be packaged and applied at different types of colleges and universities with overweight students. (2) "mi band step challenge" has the potential to be used for the reference of the healthy weight - physical activity, which is embedded in the school health promotion program executed by the ministry of education. (3) the result of this study can serve as an example for the promotion of evidence-based health care.


Eligibility criteria:
inclusion criteria: * university students with a body mass index of 24 kg/m2 or above at one university campus. * no physical limitations that would prevent them from performing physical activity. * not currently pregnant women. * having a smart phone that would allow them to connect to a mi band. exclusion criteria: * the university student who expects to be absent for more than 2 weeks or expects a suspension or transferring to another school during the implementation of the intervention.

Keywords: overweight body mass index university students physical activity sedentary behavior body composition mi band
interventional study to assess efficacy and safety of velmanase alfa in patients with alpha mannosidosis

Conditions: Alpha-Mannosidosis

Summary: randomized, double-blind, placebo-controlled, parallel group study where subjects will receive velmanase alfa or placebo for 24 weeks. each subject undergoes to 8 complete visits at the clinic for clinical, laboratory and functional assessments. study treatment is administered weekly through i.v. infusions

a screening visit (v1) will take place 7±3 days prior to randomization in order to give the subject enough time to consider their participation in the study, to plan the next visits including the long-stay visits at v2, v5 and v8 (long-stay visits as pk and certain tests are performed over more than one day), and to allow the clinic center to complete the evaluation of the eligibility criteria. upon confirmation of eligibility, subjects will be randomized to receive weekly i.v. administration of either velmanase alfa 1 mg/kg or placebo. thereafter, subjects will undergo weekly visits for administration of study treatment and safety data collection. clinical, laboratory and functional assessments will be performed at the 4-weekly assessment visits with each subject undergoing a minimum of 8 assessment visits (v1 to v8).

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of alpha-mannosidosis based on alpha mannosidase activity \<10% of normal in leukocytes or fibroblasts or through genetic testing; * capability to comply with the protocol; * evidence of informed consent provided by subject or legally authorized guardian(s) prior to performance of any trial-related activities. exclusion criteria: * previous hematopoietic stem cells transplantation (hsct) with positive outcome; * major surgery planned within 3 months prior to study entry or planned during the study that, in the opinion of the investigator, would preclude participation in the trial; * known clinically significant cardiovascular, hepatic, pulmonary or renal disease or other medical condition that would preclude participation in the study in the investigator's judgment; * pregnant (as evident by a positive urine hcg or serum-hcg test) or lactating women and all women physiologically capable of becoming pregnant (i.e. women of childbearing potential \[wocbp\]) unless they are willing to use highly effective birth control methods; * participation in other interventional trials testing investigational medicinal products (imps) within the last 6 months; * total ige \>800 iu/ml; * any hypersensitivity to velmanase alfa or its excipients that, in the judgment of the investigator, places the subject at an increased risk for adverse reactions * clinically active infection and recent vaccinations (within the last month before screening).

Keywords: alpha-mannosidosis velmanase alfa alpha-mann shaman mannosidosis alpha-mannosidasis
treatment of alcohol withdrawal in hospital patients

Conditions: Alcohol Withdrawal Syndrome

Summary: the purpose of this study is to test how tolerable and effective lorazepam is when used to treat alcohol withdrawal in hospital patients at risk for alcohol withdrawal.

studies show that symptom-triggered dosing is best for treatment of alcohol withdrawal in patients on chemical dependence units without other illness. on general medical hospital wards, withdrawal may be affected by comorbid medical illness. a clinical trial was undertaken to determine whether there is a difference between symptom-triggered (st) and fixed-schedule (fs) dosing of lorazepam in patients hospitalized on general medical wards at a university medical center. subjects were assessed by their nurses with the revised clinical institute withdrawal assessment for alcohol (ciwa-ar) scale. subjects in the st arm received lorazepam doses based on ciwa-ar score. subjects in the fs arm received scheduled lorazepam with tapering over 4 days.

Eligibility criteria:
inclusion criteria: * alcohol dependence (based on criteria from the diagnostic and statistical manual of mental disorders, 4th edition) * daily alcohol use for at least seven consecutive days with the last use no more than 72 hours prior to enrollment * patients on the general internal medicine service exclusion criteria: * unable to give informed consent * chronically maintained on prescription sedative-hypnotics

Keywords: alcohol withdrawal symptom-triggered therapy fixed-schedule therapy ciwa-ar lorazepam (drug)
alveolar cleft reconstruction with cortical-shells

Conditions: Alveolar Cleft

Summary: the main goal of the secondary alveolar bone grafting (sabg) for alveolar clefts is the rehabilitation of the disorganized maxilla, aiming to stabilize the maxillary foundation as a solid functional mass that would abort growth disturbance, allow for teeth eruption, and enhance their orthodontic movements. the study evaluates the outcomes of a ( sabg) technique that utilizes the retromolar cortical shell technique to reconstruct the alveolar clefts.


Eligibility criteria:
inclusion criteria: 1. patients of both sexes with an age range of (eight to fifteen years), with unilateral maxillary alveolar cleft. 2. good oral hygiene and general good health exclusion criteria: 1. the evidence of clinical or radiographic signs of local maxillary pathosis or palatal fistulae. 2. those patients with bilateral alveolar clefts, cleft-associated syndromes, and those with a systemic disease that would affect either bone harvest or graft healing. 3. a history of previous failed alveolar cleft reconstruction.

Keywords: bone graft cortical- shells radiographic density horizontal bone gain vertical bone loss
effects of social media addiction on physical activity level and exercise capacity in university students

Conditions: Addiction; Social Media Addiction; Physical Inactivity

Summary: the aim of this study is to investigate the effect of social media addiction on functional exercise capacity and maximal exercise capacity in university students.

the internet, one of the new communication technologies, has become an indispensable part of human life as it makes people's lives easier, provides people with the advantage of saving time, and facilitates and accelerates information acquisition. thanks to the internet, people can do many daily tasks quickly with minimal physical effort and cost. this makes personal and business life easier. internet technology has many positive features. this network, which develops and changes daily, has become indispensable for many people. in addition to all these positive features, today, this situation emerges as a new addiction phenomenon. in cases where there is no parental or teacher supervision in their use of social media, adolescents encounter negative content. there is a high probability of being affected by the contents. sharing sites such as facebook, instagram, twitter, linkedin, youtube, and tumblr, which are very popular social media networks that have entered our lives, have been used by many people in the world and in turkey for a long time. it seems that the rapid increase in usage rates and durations will continue rather than decrease. the intense amount and duration of use brings the phenomenon of "addiction" to the agenda. people seek and express in virtual environments what they cannot achieve or express freely in real life. these types of actions increase people's usage time, so much so that this situation causes addiction. many studies have been conducted in the literature to investigate the effect of social media and digital game addiction on physical activity levels. although many studies have been conducted to examine social media addiction and the effects it causes, there is no research on the effects of social media addiction on functional exercise capacity and maximal exercise capacity. no study has been found investigating its effect. for this reason, the investigators think that there is a need for a study in this direction in the literature. the aim of this study is to investigate the effect of social media addiction on functional exercise capacity and maximal exercise capacity in university students.

Eligibility criteria:
inclusion criteria: * age between 18-30 years exclusion criteria: * chronic illnesses * can't walk or run
the effect and safety of recombinant fibroblast growth factor-1 for carpal tunnel syndrome

Conditions: Carpal Tunnel Syndrome

Summary: carpal tunnel syndrome (cts) is a common peripheral entrapment mononeuropathy of the upper limb, which results from compression of median nerve at level of wrist. in recent years, regenerative medicine has gradually been applied in the treatment of various degenerative conditions such as bones, muscles, and nerves. human fibroblast growth factor 1 is a single-chain protein , which has been shown to play a crucial regulatory role in the brain and spinal cord and can facilitate nerve cell differentiation and growth. es135 is a recombinant human fibroblast growth factor 1 (rhfgf1) which is composed of 135 amino acids with a molecular weight of approximately 15.2 kilodalton. several studies have shown that significant improvement of functional independence measure, motor and sensory function of spinal cord injury patients after es135 treatment. one study also revealed the muscle strength have significant improvement in brachial plexus injury patients after es135 therapy. according to above studies, the investigators hypothesized that es135 may have benefits to cts patients. hence, the purpose of this study aim to demonstrate the therapeutic effects and safety of es135 for cts.

participants established with diagnosis of mild-to-moderate cts will been randomly assigned to es135 or placebo groups. with ultrasound guidance, injection with es135 or placebo was performed between median nerve and transcarpal ligament. the boston carpal tunnel syndrome questionnaire is assigned as primary outcome. the secondary outcomes encompass visual analog scale, electrophysiological studies and cross-sectional area of the median nerve. the assessment is performed prior injection and at 1, 2, 3, 4 and 6 months post-injection.

Eligibility criteria:
inclusion criteria: * age between 18-80 year-old. * diagnosis was confirmed by using an electrophysiological study * cts symptoms for more than 3 months. exclusion criteria: * severe cts * allergy to es135 * pregnancy * inflammation status * cervical radiculopathy * polyneuropathy, brachial plexopathy * thoracic outlet syndrome * previously undergone wrist surgery or steroid/platelet-rich plasma injection for cts within 12 months

Keywords: carpal tunnel syndrome recombinant human fibroblast growth factor 1
retrospective study in chinese pediatric hemophilia a patients with rfⅷ contained regular prophylaxis

Conditions: Hemophilia A

Summary: to assess and describe real-life treatment choices for rfⅷ contained regular prophylaxis/bleeding prevention treatment in pediatric hemophilia patients in china (2007-2013)


Eligibility criteria:
inclusion criteria: * male, 2-\<18 years hemophilia a, based on documented prior testing and/or screening laboratory patients who had received regular prophylaxis/bleeding prevention treatment, totally/partially with rfⅷ. regular prophylaxis/bleeding prevention treatment is defined as that proportion of weeks (≥2 infusion/week) of total treatment weeks≥80%\[10\] , and total duration ≥12 weeks. during the regular prophylaxis period, if there were consecutive 4 weeks that \<2 infusion/week, the beginning day of the 4 weeks is defined as the end of regular prophylaxis. available patient medical data record written informed consent by parent/legal representative. consent should be sought from subjects if appropriate exclusion criteria: * patients with measurable inhibitor activity at baseline and history of fviii inhibitor antibody formation (≥0.6bu by bethesda assay at two different time points, documentation must be available) any individuals with another bleeding disease that is different from hemophilia a (e.g, von willebrand disease, hemophilia b)