Kornimate/medical-research-clean huggingface dataset:
the efficacy of two models of intensive upper limb training on quality of life in children with congenital hemiplegia

Conditions: Hemiplegia; Congenital

Summary: this study compared the effectiveness of two-mode of activity-based upper limb rehabilitation (modified constraint-induced movement therapy and bimanual training) on health-related quality of life outcomes in school-aged children with cerebral palsy

a total of 52 primary schools were screened comprehensively to determine children conforming specifications of the inclusion criteria. demographic characteristics (e.g. age, gender, affected side) and severity of functional impairment dealing with cognitive /communication, manual ability and mobility were noted. after a comprehensive screening, a total of 30 children met inclusion criteria (grades 1-4) were randomly assigned to one of two groups (modified constraint-induced movement therapy or bimanual training), at an equal number and probability. children blinded to group allocation were delivered activity-based upper limb training in the context of modified constraint-induced movement therapy or bimanual training, at a similar dose and frequency (10 weeks/3 days per week/2.5 hours per day). 1 out of 3 sessions per week was carried out in the school time (during the art or physical education class), while 2 out of 3 sessions were carried out in rehabilitation centers which the children regularly attend for regular care 2-day weekly. all participating children continued to receive their standard care (90 minutes per week) throughout the study period. during the 1-month screening period, physical characteristics of participants were described through classification systems including the communication function classification system, the manual ability classification system , and the gross motor function classification system. participating children were evaluated before the study entry (t1), immediately postintervention (t2), and at 16 weeks postintervention (t3) using the kidscreen-27 questionnaire

Eligibility criteria:
inclusion criteria: * clinical diagnosis of congenital hemiplegia, * must be able to grasp objects exclusion criteria: * cerebral palsy dependent severe emotional difficulties
bip cvc clinical safety and performance study

Conditions: Surgery; Central Line Associated Blood Stream Infections (CLABSI)

Summary: the primary objective of this trial was to determine bactiguard coated bip cvc's safety and performance and compare it to corresponding standard uncoated cvc.

the primary objective of this study is to determine the safety for the medical device of 'bip central venous catheter". safety is assessed by evaluation of adverse events (according to iso 14155:2011). examples of cvc related common events are phlebitis, infection at the infection site, catheter related bacteremia/fungemia, septicemia, sepsis, thrombosis, lung emboli and pneumothorax. the secondary objective is to assess the overall performance by evaluating if there were any cvc handling problems experienced by the physician/health care personnel. furthermore, an exploratory objective of this study is to assess coating and microbial colonization. included in the study were men and women aged 18 years or older undergoing elective standardized large surgery with a planned cvc catheterization in right or left jugular vein or subclavian vein planned for at least 3 days. this study is a single-centre, randomized, single-blind, controlled study of tolerability and safety of bip cvc with noble metal alloy coating. all statistical analyses is performed using the sas® system, version 9.3 or higher (sas institute inc., cary, nc, usa). data is to be summarized using descriptive statistics.

Eligibility criteria:
inclusion criteria: * adult men and women ≥ 18 years of age * were, in the opinion of the investigator, able to communicate with and understand the trial personnel and comply with the requirements of the trial * requiring cvc catheterization for venous access, via right (most often) or left jugular vein or subclavian vein, during and after elective large surgery (liver or pancreas resection or intestinal/bowel surgery) planned for at least 3 days * had signed the informed consent exclusion criteria: * known transmissive blood disease * known multiresistant bacterial colonization * ongoing infection * thromboembolism * anti-coagulation treatment excluding prophylaxis * cvc during last 2 months * history of problems with cvc * pregnancy

Keywords: cvc healthcare associated infections (hai) clabsi noble metal alloy coating cvc related thrombosis
matching patients with hematologic malignancy to adequate clinical trials

Conditions: Hematologic Malignancies

Summary: a molecular profile of a patient with hematologic malignancy, for whom standard-of-care had failed, is identified using next generation sequencing. patients are assigned to early clinical trials of targeted agent based on the molecular profiling or physician's choice. the improvement of outcomes in the intention-to-treat population is investigated.

most of hematologic malignancy patient becomes incurable with standard treatment during their disease course. although these patients are recommended to participate in an early phase clinical trials, the response rate have reported be only 4 to 6 percent. over several decades, a lot of cancer driving mutations has been identified, and targeted agents directed at the mutations are continuously developed and studied in many clinical trials. most of the clinical trials recruited participants regardless of mutational status of them. recently, however, participants has been recruited in recent clinical trials according to the presence of specific mutations. the response rate of these recent clinical trials is 12-75%. in this pragmatic clinical trial, cancer driving mutations in hematologic malignancy patients is identified using next generation sequencing, and assign patients to an appropriate clinical trial which is anticipated to exhibit the best response. the improvement of outcome of this biomarker-driven assignment is investigated.

Eligibility criteria:
inclusion criteria: * adults with \> 18 years old * incurable hematologic malignancy patients who failed to respond to standard treatment * patients who agreed to this protocol with informed consent * eastern cooperative oncology group performance status ≤ 3 * tolerable major organ function determined by laboratory examination exclusion criteria: * expected survival \< 3 months * patients with poor compliance * patients who can not give an informed consent * patients who are participating another clinical trials

Keywords: personalized medicine next generation sequencing
vitamin k2 supplementation and arterial stiffness in the renal transplant population (the king trial)

Conditions: Arterial Stiffness; Vitamin K2 Deficiency

Summary: this study is a single arm, single center clinical trial that aims to evaluate the effect of 8 weeks of vitamin k2 replacement (360 mcg/day) on the progression of arterial stiffness in stable renal transplant patients.


Eligibility criteria:
inclusion criteria: * functional renal graft * stable renal function for at least 3 months prior to enrollment exclusion criteria: * history of thrombotic events * diagnosed coagulopathy * cardiovascular event in the past month prior to enrollment * current or planned pregnancy * lactation * soy allergy * concomitant or recent (past 6 months) use of supplements that contain vitamin k * warfarin treatment * known intestinal malabsorption or hypomotility syndromes
exemestane in advanced and recurrent endometrial carcinoma

Conditions: Endometrial Cancer

Summary: a phase ii study of exemestane in advanced or recurrent endometrial carcinoma hypothesis: treatment with exemestane can give a response rate of at least 30%

patients with advanced or recurrent endometrial cancer of endometrioid type were treated with exemestane tablets 25 mg daily. patients were grouped according to estrogen receptor status.

Eligibility criteria:
inclusion criteria: * advanced or recurrent endometrial cancer not considered for treatment modalities apart from hormonal treatment * endometrioid histology * age above 18 years * post menopausal status * performance status 0-2 * informed consent exclusion criteria: * congestive heart disease grade iii.iv * history of thromboembolic signs * other primary hormonal therapy * patients with symptomatic brain metastasis * severe hepatic or renal impairment * pregnancy, lactation or child bearing potential without adequate contraception

Keywords: endometrial cancer
totally laparoscopic distal gastrectomy for gastric cancer

Conditions: Postoperative Complications

Summary: this study was designed as a randomized clinical trial comparing the totally laparoscopic distal gastrectomy with laparoscopy-assisted distal gastroectomy for patients with gastric cancer, in terms of short-term and long-term outcomes.

when one patient was enrolled, he will be randomly divided into experimental group (totally laparoscopic distal gastrectomy) or control group (laparoscopy-assisted distal gastrectomy). when he receives surgery, intraoperative parameters would be recorded. when the patient discharges, the routine follow-up would be regularly performed for the survival.

Eligibility criteria:
inclusion criteria: * aged 18-80 years old, no gender limitation; * primary gastric cancer and planed for distal gastrectomy; exclusion criteria: * patients with total or proximal gastrectomy; * patients with distant metastasis.

Keywords: laparoscopy-assisted gastrectomy totally laparoscopic gastrectomy distal gastroectomy postoperative hospital stay survival complications
investigating the effectiveness of eylea in patients with wet age-related macular degeneration

Conditions: Wet Age-related Macular Degeneration

Summary: the study aims to investigate the effectiveness of eylea in patients with wet age-related macular degeneration in routine clinical practice in germany. the study is purely observational, only data from routine treatment are to be collected. the treatment and treatment conditions are solely at discretion of the treating physician.


Eligibility criteria:
inclusion criteria: * patients with wet wamd treated with eylea (in accordance with the local summary of product characteristics, spc). * written informed consent. exclusion criteria: * exclusion criteria as listed in the local spc. * scar, fibrosis, or atrophy involving the center of the fovea in the study eye. * any concomitant therapy with another agent to treat wet amd in the study eye.

Keywords: wet age-related macular degeneration anti-vegf-therapy observational study
human pulpal response after pulp capping with four different agents

Conditions: Dental Pulp Exposure

Summary: application of four different pulp capping methods on human sound premolars after intentional exposure of the buccal pulp horn through a class one occlusal cavity.

the purpose of this clinical trial is to compare the effect of different direct pulp capping methods on human pulpal response in the terms of inflammation \& dentinal bridge formation. methods: eight patients providing 32 sound first premolars are selected. as recommended by iso / tc 7405 pulpal exposure will be performed through a class i cavity. four groups of eight specimens each will be defined according to the pulp capping method. group a, will receive chemical set calcium hydroxide (dycal). group b, will receive mineral trioxide aggregate (mta) according to manufacturer's instruction. group c, will receive mta and after its primary setting, within 15 minutes, the cavity is restored in the same appointment. group d, will receive multical as a direct pulp capping agent. specimens will be assessed in the terms of dentinal bridge formation, its appearance compared to natural dentin, its thickness and inflammatory pulpal response. the last item will be scored 0-3 in which 0 corresponds to none, 1 to minimal, 2 to moderate and 3 to severe inflammation. in case of an abscess or true tissue necrosis, a score of 4 will be given as recommended by iso / tc 7405.

Eligibility criteria:
inclusion criteria: * patients aging from 10 to 16 * patients who need to extract 4 premolars for orthodontic purposes * the teeth should be free of caries and clinical symptoms * through thermal tests and radiographic examination absence of any pathology is confirmed. * periapical radiographs demonstrating absence of any pathology * no sensitivity to percussion, palpation and biting, no sensitivity to cold after 5 seconds contact with green endo ice refrigerant spray, heat sensitivity after applying tempered gutta percha for 10 seconds. * absence of any systematic disorder * no consumption of drugs of any kind * all patients and their parents need to sign a fully informed consent. exclusion criteria: * if any of the teeth shows caries, restoration, crack or hypocalcification * presence of any periapical pathosis * teeth that seem sensitive to cold, hot, percussion or pressure * any systematic disorder * consumption of drugs of any kind.

Keywords: direct pulp capping mta single visit pulp cap multical
ridge preservation comparing 2 membranes

Conditions: Alveolar Ridge Deficiency

Summary: the purpose of this study is to compare the clinical and histologic outcomes for acellular dermal matrix and a nonresorbable membrane to determine if either provides a significant therapeutic advantage. the hypothesis is that there will be no difference in crestal ridge width between the two treatments.

30 patients will be selected that meet the following criteria: inclusion criteria 1. have one non-molar tooth requiring extraction that will be replaced by a dental implant. the site must be bordered by at least one tooth. 2. healthy male or female who is at least 18 years old. 3. patients must sign an informed consent approved by the university of louisville human studies committee. exclusion criteria 1. patients with debilitating systemic diseases, or diseases that have a clinically significant effect on the periodontium. 2. presence or history of osteonecrosis of jaws. 3. patients who are currently taking iv bisphosphonates or who had iv treatment with bisphosphonates irrespective of duration. 4. patients who have been treated with oral bisphosphonates for more than three years. 5. patients with an allergy to any material or medication used in the study. 6. patients who need prophylactic antibiotics. 7. previous head and neck radiation therapy. 8. chemotherapy in the previous 12 months. 9. patients on long term nsaid or steroid therapy. 10. pregnant patients.

Eligibility criteria:
inclusion criteria: 1. have one non-molar tooth requiring extraction that will be replaced by a dental implant. the site must be bordered by at least one tooth. 2. healthy male or female who is at least 18 years old. 3. patients must sign an informed consent approved by the university of louisville human studies committee. exclusion criteria: 1. patients with debilitating systemic diseases, or diseases that have a clinically significant effect on the periodontium. 2. presence or history of osteonecrosis of jaws. 3. patients who are currently taking iv bisphosphonates or who had iv treatment with bisphosphonates irrespective of duration. 4. patients who have been treated with oral bisphosphonates for more than three years. 5. patients with an allergy to any material or medication used in the study. 6. patients who need prophylactic antibiotics. 7. previous head and neck radiation therapy. 8. chemotherapy in the previous 12 months. 9. patients on long term nsaid or steroid therapy. 10. pregnant patients.

Keywords: allograft acellular dermal matrix alveolar ridge
multi-center study of sensory stimulation to improve brain function

Conditions: Alzheimer Disease; Cognitive Impairment; Mild Cognitive Impairment; Dementia Alzheimers; Dementia, Mild; Dementia, Alzheimer Type; Dementia of Alzheimer Type; Dementia; Cognitive Impairment, Mild; Cognitive Decline

Summary: the overture study is a randomized, controlled, single-blind multi-center clinical trial using the gammasense stimulation system to study safety, tolerability, and efficacy in people with mild to moderate cognitive impairment.

the overture study (ca-0005) is a phase i/ii randomized, controlled, single-blind multi-center clinical trial using the gammasense stimulation device to study safety, adherence rates and efficacy in subjects with mild to moderate cognitive impairment (mmse 14-26) who are age 55 and older. subjects who pass screening will be randomized (ratio 2:1 treatment to control). subjects and their caregivers will be blinded to their randomization group, as will key raters at each site. the device will be used for 60 minutes daily during the 6-month therapy phase, followed by a one month safety follow-up visit.

Eligibility criteria:
inclusion criteria: * \>= 55 years old * mmse 14-26 * prodromal alzheimer's disease (ad), ad or mild cognitive impairment (mci) due to ad * participation of a caregiver exclusion criteria: * profound hearing or visual impairment * seizure disorder * use of memantine (namenda or namzaric) * implantable devices (non-mr compatible)

Keywords: dementia alzheimer's disease cognitive impairment
china research of idegasp treatment in real-world clinical practice (create)

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this study is to collect information on how ryzodeg® works in real-world patients. participants will get ryzodeg® as prescribed to by their doctor. the study will last for about 5-8 months. participants will be asked questions about their health and their diabetes treatment as part of their normal doctor's appointment


Eligibility criteria:
inclusion criteria: 1. signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol). 2. the decision to initiate treatment with commercially available ryzodeg® has been made by the patient/legally acceptable representative (lar) and the treating physician based on the approved ryzodeg® label in china and independently from the decision to include the patient in this study. 3. male or female, age above or equal to 18 years at the time of signing informed consent. 4. diagnosed with t2dm and treated with any anti-hyperglycaemic medication(s) other than ryzodeg® for at least 20 weeks prior to treatment initiation visit (visit 1). 5. available and documented glycosylated haemoglobin (hba1c) value below or equal to 12 weeks prior to informed consent and treatment initiation visit (visit 1). exclusion criteria: 1. previous participation in this study. participation is defined as having given informed consent in this study. 2. treatment with any investigational drug within 30 days prior to enrolment into the study. 3. mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation. 4. known or suspected hypersensitivity to the active substance or to any of the excipients as specified in the approved ryzodeg® label in china.
a study of ly900014 compared to insulin lispro in participants with type 2 diabetes

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to compare ly900014 to insulin lispro, both in combination with insulin glargine or insulin degludec, in participants with type 2 diabetes (t2d).


Eligibility criteria:
inclusion criteria: * have been diagnosed (clinically) with t2d, based on the world health organization (who) classification for at least 1 year prior to screening. * have been treated for at least 90 days prior to screening with: * basal insulin (insulin glargine u-100 \[basaglar/abasaglar or lantus\] or u-300, insulin detemir, insulin degludec u-100 or u-200, or neutral protamine hagedorn \[nph\] insulin) in combination with at least 1 prandial injection of bolus insulin (insulin lispro u-100 or u-200, insulin aspart, insulin glulisine, or regular insulin) or * premixed analog or human insulin regimens with any basal and bolus insulin combination injected at least twice daily * participants may be treated with up to 3 of the following oral antihyperglycemic medications (oams) in accordance with local regulations: * metformin * dipeptidyl peptidase-4 (dpp-4) inhibitor * sodium glucose cotransporter 2 (sglt2) inhibitor * sulfonylurea * meglitinide * alpha-glucoside inhibitor * have an hba1c value between ≥7.0 and ≤10.0%, according to the central laboratory at the time of screening. * have a body mass index (bmi) of ≤45.0 kilograms per meter squared at screening. exclusion criteria: * have been diagnosed, at any time, with type 1 diabetes (t1d) or latent autoimmune diabetes in adults. * have hypoglycemia unawareness as judged by the investigator. * have had any episode of severe hypoglycemia within the 6 months prior to screening. * have had 1 or more episodes of diabetic ketoacidosis or hyperglycemic hyperosmolar state within the 6 months prior to screening. * have used thiazolidinediones, glucagon-like peptide 1 (glp-1) receptor agonist, or pramlintide within 90 days prior to screening.
cardiogoniometry for early diagnosis of coronary artery disease symptomatik

Conditions: Stable Angina Pectoris

Summary: the register study cgm@cad will examine whether cardiogoniometry can provide additional information concerning the indication for a diagnostic coronary angiography and if so, which additional value it has. therefore, an additional cardiogoniometry will be carried out in consecutive patients who have been diagnosed with myocardial ischemia by means of established methods (exercise ecg, stress echocardiography, myocardial scintigraphy, or stress-mrt) and for whom an intracardiac catheter examination is regarded as indicated. the results of the different methods - particularly the results of the exercise ecg and the cardiogoniometry - will be checked against the results of the invasive examination as gold standard and the discharge diagnosis with regards to any correlation.


Eligibility criteria:
inclusion criteria: * indication for a coronary angiography * age \> 18 years * patients written informed consent exclusion criteria: * patients with known chd (condition after myocardial infarction and/or angio-graphically proven stenosis \> 50% and/ or revascularization ) * patients with acute coronary syndrome * patients with pace maker * severe valvular heart defect * 50% extrasystole * patients with dysrhythmia, which make a correct interpretation impossible (e.g. ves, bigeminies and other dysrhythmia with a high impact such as atrial extrasystoles) * branch block * atrial fibrillation

Keywords: cardiogoniometry stable angina pectoris patients