Kornimate/medical-research-clean huggingface dataset:
evaluation of maxillary molar distalization with two bone supported protocols using cone beam computed tomography

Conditions: Class II Malocclusion

Summary: the goal of this clinical trial is to to evaluate and compare the skeletal and dental changes of bone supported fast back and bone supported modified leaf spring self-activated expander in bilateral distalization of maxillary molars using cbct in egyptian people. the main question it aims to answer are: • if bone supported fast back and bone supported modified leaf spring self-activated expander will be effective in bilateral distalization of maxillary molars the patients will be selected according to the following criteria: 1. patient with full permanent dentition. 2. good oral hygiene. 3. none of the patients had received any orthodontic treatment. 4. class ii molar relationship. 5. minimal or no crowding in the mandibular arch. 6. non-extraction treatment plan with molar distalization. 7. low angle cases. 8. no medical problems or active periodontal disease. researchers will compare between bone supported fast back appliance and bone supported modified leaf spring self-activated and see if they will be effective in maxillary molars distalization.

the patients will be divided into two groups: group 1: consisted of 10 patients, their upper molar will be distalized with bone suppored fast back (fast back rapid distalizer, leone, s.p.a, italy). group 2: consisted of 10 patients, their upper molar will be distalized with bone supported modified leaf spring self-activated expander. (leaf self expander, leone, s.p.a, italy). * assessment of the 3d dentoskeletal treatment effects of the palatally bone supported fast back and palatally bone supported modified leaf spring self-activated expander will be performed by using the cbct scans. * pretreatment cbct (t1) and post-distalization until study completion with an average of 1 year (t2) for each subject all data will be collected, tabulated and statistically analyzed using the spss.

Eligibility criteria:
inclusion criteria: * patient with full permanent dentition. * good oral hygiene. * class ii molar relationship. * non-extraction treatment plan with molar distalization. * low angle cases. * medical problems or active periodontal disease. exclusion criteria: * the patients had received any orthodontic treatment. * crowding in the mandibular arch. * medical problems or active periodontal disease.

Keywords: molar distalization fast back distalizer leaf spring self-activated expander
algovita post-market clinical study: spinal cord stimulation to treat chronic pain

Conditions: Chronic Pain

Summary: the purpose of this study is to obtain real-world clinical outcome data for the algovita spinal cord stimulation system when used, on-label, according to the applicable directions for use.


Eligibility criteria:
inclusion criteria: * patient is eligible for scs therapy according to the algovita scs system indications for use statement * patient had successful algovita scs system stimulation trial with an algovita scs system and will be implanted with a permanent algovita scs system; prior approval must be obtained from the sponsor if another scs system was used for the stimulation trial * patient is willing and able to sign an irb/ec approved informed consent, and in the united states, a privacy protection authorization, as required exclusion criteria: * patient is contraindicated for an algovita scs system * patient has a cognitive impairment, or exhibits any characteristic, that would limit study candidate's ability to assess pain relief or complete study assessments * patient has a life expectancy of less than 2 years * patient is participating in another clinical study that would confound data analysis * patient has a coexisting pain condition that might confound pain ratings

Keywords: spinal cord stimulation chronic pain failed back surgery syndrome
continuous ward monitoring with the ge portrait mobile monitoring solution: the cosmos trial

Conditions: Postoperative Complications

Summary: the investigators plan to determine whether unblinded continuous ward monitoring with the ge portrait mobile monitoring solution and nursing alerts reduces vital sign abnormalities in patients recovering from major noncardiac surgery.

primary aim. determine whether unblinded continuous ward monitoring with the ge portrait mobile monitoring solution and nursing alerts reduces vital sign abnormalities in patients recovering from major noncardiac surgery. primary hypothesis. unblinded continuous ward monitoring and nurse alerts reduces vital sign abnormalities during the initial 48 postoperative hours after major non-cardiac surgery while patients remain hospitalized. secondary aim. determine whether continuous ward saturation, ventilation, and pulse rate monitoring reduces a composite of substantive respiratory and cardiovascular interventions. secondary hypothesis. unblinded continuous ward monitoring increases a composite of clinical interventions for desaturation, hypoventilation, tachypnea, tachycardia, and bradycardia within 48 hours after major non-cardiac surgery.

Eligibility criteria:
inclusion criteria: 1. are expected to be admitted to one of the wards equipped with the ge portrait mobile monitoring solution; 2. are ≥18 years old; 3. are designated american society of anesthesiologists physical status 1-4; 4. are scheduled for major noncardiac surgery lasting at least 1.5 hours; 5. are expected to remain hospitalized at least one postoperative night; 6. are expected to have general or neuraxial anesthesia. exclusion criteria: 1. have language, vision, or hearing impairments that might compromise continuous monitoring; 2. are designated do not resuscitate, hospice, or receiving end of life care; 3. are expected to have telemetry monitoring; 4. have previously participated in the study.

Keywords: postoperative anesthesia vital signs
study of biomarkers in diabetic chronic wounds

Conditions: Diabetes Mellitus; Biomarker; Chronic Wound

Summary: this study aims to discover, verify and evaluate the potential biomarkers with regard to the diagnosis, prognostic and/or prediction of diabetic chronic wounds.

investigators will conduct a multicenter prospective case control study consisting of three stages. in the first stage, investigators will collect clinical data and blood, urine and stool samples from diabetic patients with chronic wound (cwd), diabetic patient without newly identified wound (nwd) and patients without diabetes (nd to discover the candidate bioindicator with differences through combined high-throughput non targeted detection. in the second stage, investigators will expand the sample size and collect the clinical data and biological samples (blood, urine and stool) of the cwd,nwd and nd participants to verify the difference of the candidate bioindicator in the first stage by targeted technologies. in the third stage, investigators will collect the clinical data and biological samples (blood, urine and stool) of the cwd and nwd participants to evaluate the value of these candidate bioindicators as biomarkers.

Eligibility criteria:
inclusion criteria: 1. age between 18 and 75; 2. signed the informed consent form； 3. subjects in the nd group are the healthy participants without diabetes； 4. subjects in the nwd group are the diabetic participants without newly identified wounds； 5. subjects in the cwd group are the diabetic participants with chronic wounds exclusion criteria: 1. with sever acute underlying diseases of the brain, heart, lungs, liver and/or kidney; 2. no diabetes but combined with lower limb arterial stenosis, occlusion or other conditions affecting wound healing or other causes of wounds such as varicose veins in the lower limbs; 3. special exclusion criteria for blood, urine and stool samples taking.

Keywords: chronic diabetic wound early diagnosis prognostic prediction biomarker muti-omics
cognitive assessments in patients with cancer undergoing chemotherapy

Conditions: Malignant Neoplasm; Unspecified Adult Solid Tumor, Protocol Specific

Summary: this pilot clinical trial studies cognitive assessments in patients with cancer undergoing chemotherapy. questionnaires that measure cognitive changes during chemotherapy may help identify the side effects of chemotherapy.

primary objectives: i. to assess the feasibility of administering a cognitive assessment battery in a medical oncology clinic. secondary objectives: i. to estimate the variability of the various cognitive tests and to assess changes in cognitive performance based on the results of cognitive assessments obtained prior to chemotherapy and at 6 to 8 weeks and 12 to 16 weeks after the initiation of chemotherapy. ii. to explore the association of cognitive performance with the eastern cooperative oncology group (ecog) performance status as evaluated by the patient's oncology team. iii. to assess the association between cognitive performance and the occurrence of a serious adverse event during chemotherapy. outline: patients complete cognitive assessments, comprising hopkins verbal learning test-revised (hvlt-r), trail making test parts a \& b (tmt-a, tmt-b), digit symbol coding test (dsc), category fluency test (animals), montreal cognitive assessment (moca), and digit span test (dst). patients also complete the beck depression inventory. assessments are administered on day 1 of chemotherapy and at 6-8 weeks and 12-16 weeks after day 1 of chemotherapy.

Eligibility criteria:
inclusion criteria: * patients must have histologically or cytologically confirmed cancer * patients are candidates for systemic chemotherapy for their cancer diagnosis * life expectancy must be greater than 6 months * ability to understand and the willingness to sign a written informed consent document exclusion criteria: * patients who have had prior systemic chemotherapy in their lifetime * patients with known brain metastases should be excluded from this clinical trial because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events * patients may not be participating on any other study investigating cognitive function * patients who are non-english speaking are ineligible * patients with hematologic malignancies are ineligible * patients with primary central nervous system malignancies are ineligible
nebulized 3% hypertonic saline in the treatment of acute bronchiolitis

Conditions: Acute Bronchiolitis

Summary: this is a randomized, double-blind, controlled trial in the pediatric emergency department. the primary objective is to determine whether nebulized 3% hypertonic saline is more effective than nebulized 0.9% saline in the treatment of bronchiolitis in the emergency department.


Eligibility criteria:
inclusion criteria: * children 2-12 months of age presenting to emergency department * patients with a diagnosis of bronchiolitis defined as the first episode of wheezing and/or crackles in a child younger than 12 months who has physical findings of a viral respiratory infection and has no other explanation for the wheezing and/or crackles * patients with an rdai score ≥ 6 as measured by a trained respiratory therapist exclusion criteria: * previous history of wheezing * known heart or lung disease * premature birth defined as birth before 37 weeks gestation * immunosuppression or immunodeficiency * treatment with corticosteroids in the previous 48 hours * critically ill children - progressive respiratory failure requiring higher level of care, vital signs instability/need for emergency interventions to prevent clinical deterioration * oxygen saturation \<85% on room air at the time of recruitment

Keywords: bronchiolitis hypertonic saline emergency department
acupuncture to treat cancer-related fatigue in breast cancer patients

Conditions: Fatigue

Summary: this study will evaluate if acupuncture is helpful in treating cancer-related fatigue in breast cancer patients undergoing radiation therapy.

each participant will have a baseline visit before her radiation therapy begins to complete questionnaires. participants will receive either true acupuncture or sham acupuncture twice per week for the six weeks of radiation therapy. she will have a short questionnaire at three weeks into her radiation, and she will complete questionnaires again at the end of her radiation and four weeks later.

Eligibility criteria:
inclusion criteria: * localized breast cancer * average to above average fatigue * planning radiation therapy exclusion criteria: * history of acupuncture treatment * allergy to stainless steel * pacemaker * anticoagulant therapy * known bleeding disorder * metastatic breast cancer * seizure disorder

Keywords: cancer-related fatigue acupuncture breast cancer
mechanical stimulation on pain level and functional discomfort after breast cancer surgery

Conditions: Breast Cancer

Summary: this study evaluates the effectiveness of mechanical stimulation technique compared to massages on pain level and functional discomfort (on the mobility of the shoulder) after 6 months, in breast cancer needing physiotherapy, following a total mastectomy and exploratory axillary surgery.

a prospective, monocentric, randomized, open-labelled in two parallel groups study that evaluates the effectiveness of mechanical stimulation technique compared to massages on pain level and functional discomfort (on the mobility of the shoulder) after 6 months in breast cancer patients needing physiotherapy, following a total mastectomy and exploratory axillary surgery. other objectives of the study include: * evaluate the efficacy of mechanical stimulation technique compared to massages on pain and functional discomfort (on the mobility of the shoulder) 15 days after the end of physiotherapy. * evaluate the impact of mechanical stimulation on the quality of life of patients, in comparison to those receiving massages

Eligibility criteria:
inclusion criteria: * age \> 18 years * patient who had total mastectomy for a breast cancer or pre-cancerous lesions * associated with axillary dissection or removal of the sentinel lymph nodes * presenting with functional discomfort and/or pain at the control consultation, 3 weeks after the mastectomy and justifying the prescription of physiotherapy * possibility to be treated by a physiotherapist who can carry out both techniques and accepts to perform either one of the techniques according to the randomized allocation of the treatment * patient covered by the french social security regime * signed and informed consent exclusion criteria: * immediate breast reconstruction * total bilateral mastectomy * contraindication to mechanical stimulation technique * patient who are planning to move houses in the next 6 months * patients under guardianship

Keywords: breast cancer mechanical stimulation mastectomy
feasibility of the camp power up program on children's body weight and quality of life

Conditions: Obesity, Childhood; Weight Change, Body; Quality of Life

Summary: this study will evaluate the effects of a one week weight management summer camp on children's weight, quality of life, mood and feelings, self-esteem, weight management efficacy, enjoyment of physical activity, and body image.

obesity affects 17% of children and adolescents in the u.s. children are entrenched in an obesogenic environment, often with little support in the home, school, or medical environment to make healthy choices. obesity is increasingly common in underserved communities that lack access and resources for physical activity and healthy eating. louisiana is a prime example of the need for effective obesity treatment, ranking 1st nationally for adult obesity and 4th for adolescent obesity with the highest obesity prevalence among african american adolescents. we urgently need evidence-based programs to help children and families change lifestyle behaviors, achieve clinically significant weight loss, and thereby reduce the prevalence of pediatric obesity. the u.s. preventive services task force identifies behavioral treatment including dietary, physical activity, and behavioral counseling components as a viable option for pediatric obesity treatment, yet a key challenge is how to implement these programs to maximize access and participation. summer (between school years) represents an opportunity for intensive intervention to change health behaviors and help children to lose weight. during the summer months, children gain weight at a more rapid pace and spend more time engaged in sedentary behavior compared to the school year. the american diabetes association launched camp power up as a summer week-long day camp for youth who are obese and/or at high risk for developing type 2 diabetes. the camp will focus on wellness education, nutrition, physical activity, and obesity prevention. the purpose of the proposed study is to examine effects of camp power up on children's weight status and their psycho-social health.

Eligibility criteria:
inclusion criteria: * aged 6 to 14 years * enrolled in the american diabetes association (ada) camp power up exclusion criteria: -
a clinical study to evaluate the safety and efficacy of jhm03 in adult patients with upper limb spasticity

Conditions: Upper Limb Spasticity

Summary: this is a phase ib/ii clinical study to evaluate the safety and efficacy of recombinant botulinum toxin type a（jhm03）in adult patients with upper limb spasticity. the purpose of this study was to observe efficacy and safety of jhm03 compared with placebo in adult patients with upper limb spasticity.


Eligibility criteria:
inclusion criteria: * participant must be 18 to 80 years of age inclusive, at the time of signing the informed consent * body weight ≥50kg * participants with stable post-stroke spasticity (uls) for at least 3 months * participants with modified ashworth scale (mas) score of at least 2 at elbow flexor or wrist flexor or finger flexor * participants with das score of at least 2 on the principal target of treatment (ptt) (one of four functional domains: dressing, hygiene, limb position and pain) * participants who have been stable for at least 1 month prior to study entry in terms of oral antispasticity exclusion criteria: * previous use of any botulinum toxin within 6 months prior to screening, or plan to use any botulinum toxin during the study. * history of alcohol or drug abuse. * known allergy or hypersensitivity to any component of the study products. * history of epilepsy * known or suspected to be hiv positive, serologically positive for syphilis, or active hepatitis b or c * any medical condition that may put the participant at increased risk for botulinum toxin type a use
donor-derived car-t cells in the treatment of aml patients

Conditions: AML

Summary: this is a clinical study to evaluate the safety and efficacy of donor-derived car-t cells in the treatment of patients with relapsed or refractory acute myeloid leukemia in china.

this is a single-center, single-arm, open-label study. this study is planned to enroll about 9 subjects with relapsed or refractory acute myelogenous leukemia and 9 matched donors for leukapheresis and car-t cells manufacture. donor-derived car-t cells were then infused intravenously into subjects, in a dose-escalating 3+3 design.

Eligibility criteria:
inclusion criteria: * refractory or relapsed aml patients. * have found an appropriate matched donor for car-t cells manufacturing. * patients must have evaluable evidence of disease. * age ≥ 18 years; expected survival is more than 3 months. * ecog score 0-2 points. * women of childbearing age have negative blood pregnancy test before the start of the trial, and agree to take effective contraceptive measures during the trial until the last follow-up; male subjects with partners of childbearing potential agree to take effective contraceptive measures during the trial until the last follow-up. * adequet liver, kidney, heart and lung function. exclusion criteria: * confirmed acute promyelocytic leukemia; or recent symptomatic central nervous system leukemia. * patients with graft-versus-host disease requiring the use of immunosuppressive agents; or patients with autoimmune system diseases. * prior use of any gene therapy product. * history of epilepsy or other central nervous system diseases. * presence of concurrent active malignancy. * active hepatitis b or c virus, patients with hiv or syphilis infection. * currently participating in or having participated in other drug clinical trials during past 30 days. * active or uncontrolled infection requiring systemic therapy within 14 days prior to enrollment. * other situations not suitable for the study judged by the investigator.

Keywords: car-t immunotherapy
bladder wall blood perfusion pattern and sexual dysfunction in female patients with lower urinary tract symptoms, and the association of that perfusion pattern and therapeutic efficacy of antimuscarincs for female overactive bladder syndrome.

Conditions: Lower Urinary Tract Symptoms

Summary: overactive bladder syndrome (oab) affects around 17 % of female population. however, the etiology of oab is complicated and unclear in many aspects. bladder wall thickness had been reported to be strongly associated with oab, but its use as a screening tool remains controversial. besides, few studies reported patterns of sexual dysfunction in female patients with lower urinary tract symptoms (luts). therefore the aims of our study were to analyze the bladder wall blood perfusion pattern in female luts patients, the association of between the bladder wall blood perfusion pattern and the efficacy of anti-muscarinic treatment for female oab, and the patterns of sexual dysfunction in the female luts patients.


Eligibility criteria:
inclusion criteria: * all cases are female patients with lower urinary tract symptoms exclusion criteria: * nil

Keywords: luts
anti-alpp car-t cells immunotherapy for advanced solid tumors

Conditions: Solid Tumors

Summary: the goal of this clinical trial is to evaluate the safety and efficacy of anti-alpp chimeric antigen receptor (car)-modified t (car-t) cells in treating patients with alpp-positive advanced solid tumors.

primary objectives: to evaluate the number of alpp-positive participants with treatment-related adverse events as assessed by ctcae v4.0 after infusion with anti-alpp car-t cells. secondary objectives: the number of patients experience objective response from anti-alpp car-t cells treatment to evaluate the progression-free survival (pfs) of anti-alpp car-t cells in patients with alpp-positive patients. the number and percent of alpp-cart cells in peripheral blood from alpp-positive patients at 6 months after infusion

Eligibility criteria:
inclusion criteria: * expected to survive more than 3 months * ps 0-2 * immunohistochemistry was confirmed to be mesothelin positive alpp (higher than 50%) * patients with no curative regimen to receive * wbc\>3.5×1e+9/l,hb\>90g/l,plt\>75×1e+9/l * hbv dna copy number less than 100/ml * alt≤5uln, ast≤5uln, tb≤1.5uln, alb≥35g/l * understand this test and have signed informed consent exclusion criteria: * autoimmune diseases, or any uncontrolled active disease that hinders participation in the trial * decompensated liver cirrhosis, liver function child-pugh c grade * portal vein tumor thrombus, arterial portal fistula, hepatic arteriovenous * long-term use of immunosuppressive agents after organ transplantation * screening indicated that the target cell transfection rate was less than 30% * invasive pulmonary embolism, deep venous thrombosis, or other major arterial / venous thromboembolic events occurred 30 days or 30 days prior to randomization * subjects had an active or uncontrollable infection requiring systemic therapy 14 days or 14 days prior to randomization * pregnant or lactating subjects * in the opinion of the investigator, the presence of a medical history or a history of mental state may increase the number of subjects associated with the risk factors associated with the study or study drug administration * subjects who have signed a written consent or who are in compliance with the study procedure; or who are unwilling or unable to comply with the study