Kornimate/medical-research-clean huggingface dataset:
phase i clinical trial of a candidate pcv13 in healthy people aged 6 weeks and above

Conditions: Pneumococcal Infections; Streptococcal Infections; Bacterial Infections

Summary: streptococcus pneumoniae is a major cause of morbidity and mortality in children worldwide, resulting in up to 1 million pediatric deaths every year.since the licensure of pcv7 and pcv13,the reported overall decline in invasive pneumococcal disease in hospitalized children younger than 5 years several years is approximately 60% in western countries.this is a single center,blind, randomized, positive-controlled clinical trial.the purpose of this study is to preliminary evaluate the safety of pcv13i vaccine in subjects at age of 7 months and above,and to investigate the safety and immunogenicity of pcv13i vaccine at age of 2 and 3 months,compared to pcv13.


Eligibility criteria:
inclusion criteria: * healthy subjects of 2 months (minimum 6 weeks), 3 months , 7 months and above; * willing to provide proof of identity; * without vaccination history of pneumococcal vaccine; * none-pregnancy or do not plan to pregnancy recently;; * volunteers of 18 years old and above who have the ability to understand clinical studie progress and sign informed consent; * volunteers of 8-17 years old and their guardians who willing sign informed consent; * able to understand and sign the informed consent by their guardians or trustees for the volunteers of 8 years old and below; * able and willing comply with the requirements of the protocol ; exclusion criteria: * volunteers whose axillary body temperature was \>37.0℃ before vaccination * volunteers who suffered from congenital malformation or developmental disorder, genetic defect, severe malnutrition, etc; * volunteers who has a history of epilepsy, convulsions or psychosis; * -allergic person; * any prior administration of blood products in last 3 month; * any prior administration of other research medicines in last 1 month; * plans to participate in or is participating in any other drug clinical study; * any prior administration of attenuated live vaccine in last 14 days; * any prior administration of subunit or inactivated vaccines in last 7 days; * had fever before vaccination, volunteers with temperature \>37.0°c on axillary setting; * according to the investigator's judgement, the subjects have any other factors that make them unfit to enroll the clinical trial

Keywords: pcv13 13 valent pneumococcal conjugate vaccine pneumococcal infections safety immunogenicity
effects of photobiomodulation in a population suffering from fibromyalgia

Conditions: Fibromyalgia; Chronic Pain

Summary: the development of an integral and global treatment to improve the quality of life in those with fibromyalgia syndrome (fms) is challenging, thus a whole body photobiomodulation (pbm) therapy program is proposed as an effective option.

this study is a randomized, placebo-controlled clinical trial. participants will be recruited in a private care practice and randomized to receive either a whole body photobiomodulation (pbm) therapy program or placebo. primary outcomes will be pain (numeric pain rating scale; widespread pain index; symptom severity score), functionality (fibromyalgia impact questionnaire; the leisure time physical activity instrument), quality of soft tissue (elastography) and central sensitisation (pain pressure threshold and the autonomic symptom profile). secondary outcomes will be psychological factors (pain catastrophising scale, tampa scale, self-efficacy questionnaire). assessments will be at baseline, after treatment 6, immediately following the last treatment (4 weeks), and then 2 weeks and at 3 monthly follow up intervals to 6 months after completion of treatment.

Eligibility criteria:
inclusion criteria: * patients diagnosed from fm presenting generalized pain in at least four or five regions. * present symptoms for at least 3 months at similar levels. exclusion criteria: - inflammatory, neurological, or orthopedic disease which can alter balance, hearing, and vision, and cognitive impairment in terms of the ability to answer questions.
exercise intervention in patients with heart failure with preserved and reduced ejection fraction

Conditions: Heart Failure New York Heart Association (NYHA) Class II; Heart Failure New York Heart Association (NYHA) Class III

Summary: the objective of this study is to assess by what physiological mechanisms patients with heart failure benefit from exercise. effects of an exercise intervention will be assessed for both central (heart and lungs) and peripheral (muscle fiber and mitochondria) factors.

a randomized, non-blinded prospective intervention trial. patients randomized to exercise intervention will undergo supervised aerobic training on ergometer cycle for 12 weeks whilst control group receives standard care. before and after the intervention, all participants will undergo cardiac magnetic resonance imaging (cardiac mr) examinations, ventilation/perfusion single photon emission computed tomography (v/p spect), cardiopulmonary exercise tests, muscle biopsies and blood sampling.

Eligibility criteria:
inclusion criteria: 1. signs and symptoms of heart failure 2. age ≥50 years 3. stable chronic heart failure (no hospitalizations within past month, no new medications past month) 4. able to understand and follow exercise prescription 5. currently physically inactive (less than 150 minutes/week moderate intensity exercise) exclusion criteria: 1. currently or within the past 6 months been involved in cardiac rehab with exercise 2. devices or implants not compatible with magnetic resonance imaging or exercise testing 3. any orthopedic or medical condition affecting participation in testing and training 4. signs of acute ischemia during baseline cardiopulmonary exercise testing 5. participation in other clinical trials that may affect results 6. moderate or severe valvular disease 7. atrial fibrillation 8. moderate or severe chronic obstructive pulmonary disease 9. nyha class iv
beneficial bacteria to prevent malnutrition and diarrhea in pakistani infants

Conditions: Malnutrition; Diarrhea

Summary: this study will determine whether lactobacillus gg (lgg), a beneficial bacterium, when given in yogurt, will reduce growth faltering in babies living in a poor area of pakistan who are being weaned from breastfeeding. study hypothesis: use of the probiotic bacteria lgg at the time of weaning will lessen the impact of faltering growth in babies living in the slums of pakistan.

faltering growth due to malnutrition and recurrent diarrhea is a serious public health concern in developing nations, particularly among infants who are being weaned from breastfeeding. evidence suggests that the use of the probiotic bacterium lgg reduces the risk of diarrhea, shortens episodes of diarrhea, and enhances the immune system. babies who are being weaned from breastfeeding will be given lgg-containing yogurt in this study to determine whether lgg will reduce faltering growth caused by diarrhea and malnutrition. infant participants will be enrolled at or within 5 weeks of birth and followed throughout the weaning period. during the weaning period, participants will be randomly assigned to either receive lgg-containing yogurt or placebo yogurt everyday for 3 months. all participants will have height and weight measurements taken at study entry and at month 3 (study completion). the number of diarrhea episodes experienced by participants during the study will be assessed at study completion to determine participants' health.

Eligibility criteria:
inclusion criteria: * born and reside in bilal colony, karachi pakistan during the study * parent or guardian willing to provide informed consent * parent or guardian willing to permit home visits * predominantly breastfed at study start exclusion criteria: * malnutrition at time of weaning * medical condition that would affect response to lgg

Keywords: growth and development pakistan weaning probiotics infant lactobacillus gg
prevalence of lichen planus

Conditions: Oral Lichen Planus

Summary: clinical records of all patients referred to the department of oral diseases and periodontology in the period 2021-2023 were retrogradely assesed. the prevalence of patients with the diagnosis of oral lichen planus and contributing factors were accordingly analyzed.

clinical records of 111 patients with the clinical or histopathological diagnosis of oral ichen planus were included in the study. the prevalence of oral lichen planus was calculated and all the contributing factors including age, gender, location, type, skin involvement, presence of peridontal disease, systemic diseases and medications were assesed.

Eligibility criteria:
inclusion criteria: * all patients clinically or histopathologically diagnosed with oral lichen planus exclusion criteria: * all patients not clinically or histopathologically diagnosed with oral lichen planus
novel technique for botulinum toxin injection to minimize patient discomfort

Conditions: Pain

Summary: this single blinded randomized pilot study was performed on 21 caucasian females to determine if injections through follicular openings were less painful than traditional injections for cosmetic botulinum toxin type a injections.

objective: to investigate whether injection of botulinum toxin type a is less painful if performed through follicular openings versus traditional non-specific approach. design: prospective, randomized, single-blinded study. setting: academic dermatology department. patients: a volunteer sample of twenty female patients aged 25-55 who had no prior history of botulinum toxin injection. intervention: each patient received six randomized injections of botulinum toxin type a (botox® allergan). two injections into the procerus muscle and two into each corrugator muscle. three of the injections were performed through follicular openings and three were performed traditionally. main outcome measure: patient discomfort on a 1-10 scale and direct comparison between the two injection techniques.

Eligibility criteria:
inclusion criteria: * female * no prior history of botulinum toxin * age 25-55 exclusion criteria: * male * prior history of botulinum toxin * neuromuscular disorders * aminoglycoside therapy

Keywords: botulinum toxin a botox decreasing botox injection pain injections
incidence of early infection after bipolar hemiarthroplasty and its associated factors in fracture neck of femur

Conditions: Prosthetic-joint Infection

Summary: periprosthetic joint infections (pji) following hemiarthroplasty for hip fractures are a catastrophic complication that results in severe worsening of patients' daily function and quality of life. the incidence of prosthetic joint infection (pji) in hemiarthroplasty after femoral neck fracture varies from 2% to 17%. identifying risk factors associated with early infection following ha for hip fractures may provide an opportunity to treat and prevent this potential complication with preoperative planning in many patients. so investigators will study the rate of early infection and its associated factor after bipolar hemiarthroplasty.

femoral neck fractures (fnf) have a significant incidence and a rising trend worldwide. fnf is associated with a high mortality and disability rate, decreasing the independence and quality of life for affected patients. acute displaced intracapsular femoral neck fractures account for about half of all hip fractures, with the majority of these fractures in older patients being treated surgically with hip hemiarthroplasty(ha), total hip arthroplasty, or internal fixation. hemiarthroplasty is also used to treat femoral neck nonunion, failed screw fixation, and pathological femoral neck fracture. the treatment aims are to reduce pain, allow early mobilization, and restore the patient's pre-injury level of function while limiting perioperative surgical and medical complications. patients with fnf frequently undergo hemiarthroplasty to restore joint biomechanics. two types of implants are used in hemiarthroplasty: monopolar and bipolar . the bipolar implants have a polyethylene bearing between the stem and head of the endoprosthesis, which allows the components to rotate. there are debatable findings and a lack of consensus on the optimal component for hemiarthroplasty. periprosthetic joint infections (pji) following hemiarthroplasty for hip fractures are a catastrophic complication that results in severe worsening of patients' daily function and quality of life. the incidence of prosthetic joint infection (pji) in hemiarthroplasty after femoral neck fracture varies from 2% to 17%. identifying risk factors associated with early infection following ha for hip fractures may provide an opportunity to treat and prevent this potential complication with preoperative planning in many patients. so investigators will study the rate of early infection and its associated factor after bipolar hemiarthroplasty.

Eligibility criteria:
inclusion criteria: * patients with femoral neck fractures and treated by bipolar hemiarthroplasty. * patients or their legal representative able to give informed consent. exclusion criteria: * patients that received ha secondary to a failed internal fixation of a femoral neck fracture. * patients with a pathological fracture due to malignancy.
study of tq-b3139 in subjects with anaplastic lymphoma kinase (alk) positive non-small cell lung cancer (nsclc) previously treated with crizotinib

Conditions: ALK-positive NSCLC

Summary: to evaluate the efficacy and safety of tq-b3139 in subjects with alk-positive non-small cell lung cancer that have demonstrated progression during or after crizotinib treatment whether or not previously treated with cytotoxic chemotherapy.


Eligibility criteria:
inclusion criteria: 1. 18 and 75 years. 2. eastern cooperative oncology group (ecog) performance status score of 0 to 1. 3. life expectancy ≥12 weeks. 4. histologically or cytologically confirmed diagnosis of advanced or metastatic nsclc that is alk-positive. 5. has progressive disease during or after crizotinib treatment. 6. has a measurable disease. 7. adequate organ system function. 8. understood and signed an informed consent form. exclusion criteria: 1. diagnosed and/or treated additional malignancy within 5 years prior to randomization. 2. hypersensitivity to tq-b3139 capsule. 3. has received alk tkis other than crizotinib. 4. has received any cancer therapy within 4 weeks or 5 times of t1/2. 5. has received major surgery within 4 weeks. 6. has received any radiotherapy or minor surgery within 2 weeks. 7. acute toxicity ≥ grade 2 caused by previous cancer therapy. 8. has active viral, bacterial and fungal infections within 2 weeks. 9. has serious cardiovascular diseases. 10. has currently uncontrollable congestive heart failure. 11. has continuous arrhythmia ≥ grade 2, any degree of poor controlled atrial fibrillation or qtc interval \> 480ms. 12. has interstitial fibrosis or interstitial lung disease. 13. brain metastases with symptom or carcinomatous meningitis. 14. has active hepatitis b or hepatitis c. 15. has multiple factors affecting oral medication. 16. breastfeeding or pregnant women. 17. according to the judgement of the researchers, there are other factors that subjects are not suitable for the study.
blood ammonia as predictor for esophageal varices and risk of bleeding

Conditions: Chronic Liver Disease; Esophageal Varices

Summary: assessment of blood ammonia level as a non-invasive predictor for presence of ev and risk of bleeding

a prospective cross sectional study on 150 consecutive patients screening for esophageal varices. patient groups groups: group (1): 100 patients with esophageal varices group (2): 50 chronic liver disease patients with no esophageal varices as a control group. all patients will be subjected to: 1. - detailed history-taking 2. - full clinical examination 3. - laboratory investigations: * complete blood picture (cbc) * erythrocyte sedimentation rate (esr) * renal function tests * liver function tests * prothrombin time and activity * viral markers (hcv ab - hbv ag) * blood ammonia level. 4. - pelviabdominal us: ultrasound examination of the liver, portal venous system, spleen, kidney and other abdominal organs. 5. - upper gitendoscopy: * varices will be classified according to the japanese classification 1996, * the baveno 11 score will be used to differentiate between mild and severe portal hypertensive gastropathy.

Eligibility criteria:
inclusion criteria: * patients with chronic liver disease exclusion criteria: * patient in hepatic encephalopathy or coma. * patient in active bleeding or with history of bleeding within the two weeks prior to entry in the study . * patients with heart failure. * patients with renal failure. * patient with hepatocellular carcinoma and portal vein thrombosis. * patient taking beta blockers.

Keywords: ammonia bleeding risk factors endoscopic risk signs for bleeding esophageal varices
transverse friction massage versus instrumented assisted soft tissue mobilization in quadratus lumborum syndrome

Conditions: Quadratus Lumborum Syndrome

Summary: to find effective therapeutic interventions for qls, a study is being conducted to compare the efficacy of two promising techniques: transverse friction massage (tfm) and instrument-assisted soft tissue mobilization (iastm) . participants will be randomly assigned to either the tfm or iastm groups. outcome measures will be collected before and after the intervention, including pain levels assessed through nprs, range of motion using inclinometer and posture by measuring leg length discrepancy with tape method.non probability convenience sampling will be used and 34 partcipants will be randomly allocated in two groups after meeting inclusion criteria.both groups will receive hotpack for 10-15min.stretching quadratus lumborum will also be performed with strengthening on the opposite side of affected quadratus lumborum.this methodology provides a solid assessment of the effectiveness of tfm and iastm for quadratus lumborum syndrome therapy.


Eligibility criteria:
inclusion criteria: * age group between 18-40years * males only with target population was office workers * nprs\>4 * patients with a positional fault of the pelvis (lateral tilt) * patients having chronic lbp for more than six months * hyperirritable spot or taut band * positive jump sign for trigger points/ referred pain related to the trigger point area * positive lewis's functional palpation test for ql overactivity * at least one trigger point in quadratus lumborum * leg length discrepancy due to ql tightness exclusion criteria: * congenital or acquired spinal deformities * spinal stenosis or radiculopathy * diagnosed disc prolapse * rheumatoid arthritis * any malignancy * recent history of surgery less than three months * acute infections
speckle tracking for timing of surgical operation in severe mitral regurge

Conditions: Rheumatic Heart Disease

Summary: rhumatic heart disease patients with mitral regurge untile know had adibat for timming of surgical interferance our study aim to solve this problme using a new technic in echocardiography called speckle tracking which is more accurate in estimating a changes occure to myocyte of the heart and so chosing the proper time for surgery


Eligibility criteria:
inclusion criteria: * rhuematic heart disease with severe mitral regurge exclusion criteria: * non rheumatic mitral regurge
efficiency of hemovigilance module trainings given to nurses

Conditions: Nurse's Role; Training Group, Sensitivity

Summary: the aim of the present study is to determine the effectiveness of hemovigilance module training given to nurses.

125 nurses from the clinic and intensive care units, who received the most intensive blood transfusion from two different hospitals, were included in the study as the intervention and control groups. the control group was not trained. only the pretest was administered one week after the posttest. after the pre-test was applied to the nurses in the intervention group, five modules of training, which lasted four hours, were given using interactive methods. five modules of training were prepared by the researcher. these five modules are the 1st module of training; definition of hemovigilance, its aims, the development of hemovigilance in the world and in turkey, and legal legislation, module 2; donor selection, blood donation process, phlebotomy and donor reactions, module 3; blood, blood transfusion, its purpose, properties of blood and blood components, blood transfusion process, module 4; acute and delayed transfusion reactions and management, module 5; it consists of the national hemovigilance system, the organization of the hemovigilance system at the hospital level, traceability, trace-back from the patient to the donor, and look-back from the donor to the patient. the training was over, the final test was administered. one month later, this test was repeated.

Eligibility criteria:
inclusion criteria: she/he voluntarily agrees to participate in the research, working as a nurse in the clinic and intensive care unit where blood transfusions are the most, working for at least 6 months, exclusion criteria: nurses working in the emergency and operating rooms, in clinics where blood transfusion is not performed the most, being a new nurse, on maternity leave and maternity leave, having an external assignment, nurses working in the polyclinic,
web-based delivery of effective treatment for growth in cystic fibrosis

Conditions: Cystic Fibrosis

Summary: this study will demonstrate feasibility and collect pilot data via a pilot randomized trial of 20 participants on the effectiveness of a web-based delivery system of behavioral plus nutrition intervention for parents of children with cystic fibrosis (cf) ages 4 to 9 years of age that has been found to be efficacious in face to face delivery.

optimizing nutritional status and growth improves health outcomes and survival in children with cystic fibrosis (cf). better pulmonary function, as measured by forced expiratory rate in 1 second (fev1), is associated with body mass index (bmi) above the 50th percentile for age and gender for children with cf1. evidence based practice guidelines recommend that nutritional treatment for children with cf ages 2 to 20 years should aim to achieve and maintain a bmi \> 50th percentile, however across 117 cf centers in the united states 57% of girls and 56% of boys failed to meet this recommendation1. the investigators have developed a highly effective behavioral plus nutrition intervention (be in charge) and demonstrated its efficacy when delivered face-to-face to produce weight gain and its superiority over nutrition education alone. although endorsed by the cf foundation as an evidence-based treatment, it is not available to most cf centers or families due to lack of trained personnel, cost, and distance issues. with funding from the cf foundation the investigators developed a web-based delivery system of their efficacious behavioral plus nutrition intervention for parents of children with cf ages 4 to 9 years of age. using a place outcomes award the investigators have conducted beta testing of the web-intervention and made appropriate modifications. the current study represents the next steps in refining and testing our web-based intervention. this study will demonstrate feasibility and collect pilot data on the effectiveness of the intervention in a pilot randomized trial of 20 treatment naïve participants.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of cystic fibrosis * ages 4 to 9 year * below the 50th percentile for body mass index for age and gender * and their parents exclusion criteria: * medical condition that would affect diet or growth (e.g., type 1 diabetes mellitus) * significant developmental delays * a sputum culture positive for burkholderia cepacia * a forced expiratory volume in the first second of expiration (fev1) of less than 40% * receiving enteral or parenteral nutrition.

Keywords: cystic fibrosis behavioral intervention children