Kornimate/medical-research-clean huggingface dataset:
the application of bovine basic fibroblast growth factor gel in the treatment of sensitive skin

Conditions: Sensitive Skin

Summary: the application of bovine basic fibroblast growth factor gel in the treatment of sensitive skin


Eligibility criteria:
inclusion criteria: 1. sensitive skin with a diagnosis of persistent erythema and a lactate irritation test score of 2-3 2. no related skin care products including bovine alkaline fibroblast growth factor were used within 1 month before participating in the experiment, and photoelectric treatment measures were not carried out 3. physical sunscreen should be strict during enrollment exclusion criteria: 1. children 2. have serious heart, liver, kidney, and blood system diseases, and severe immunocompromise 3. patients with mental illness or cancer 4. those who have received glucocorticoids, calcineurin inhibitors, topical small molecule drugs, antibiotics or tretinoin within 3 months 5. those who are allergic to basic fibroblast growth factor gel and its components 6. acute dermatitis of the face and perifolliculitis
the effect of customized insoles on biomechanics and pain in patients with functional flatfoot

Conditions: Flexible Flatfoot

Summary: the aim of present study is to compare the effects of 3d printing customized insoles using different thermoplastic materials on functional flatfoot patients' foot function and biomechanics

functional flatfoot is a common foot disease which induces pain and functional decline. insoles can be used for intervention and correction, especially customized insoles which are made according to different foot types. there have been few studies using 3d printing for customized insoles for functional flatfoot. besides, compared to traditional method and subtractive manufacturing, the effect of 3d printing customized insoles is still controversial and depends on technology, materials and design.the purpose of present study is to compare the effects of 3d printing customized insoles using different thermoplastic materials on functional flatfoot patients' foot function and biomechanics. twelve patients with functional flatfoot (foot function index\> 6) aged 20-65 years old will be recruited in this study. participants plan to wear three kinds of customized insoles fabricated by 3d printing with nylon and tpu or computer numerical control machine with eva. f-scan system and questionnaires will be used to record foot biomechanics and pain after wearing insoles immediately, and foot condition after three weeks. statistical analysis will be adopted for repeated-measures analysis of variance （anova） for all outcome measures and post-hoc test will be used to test the difference between groups.

Eligibility criteria:
inclusion criteria: * aged between 20 and 65 years old * appearance of decreased medial arch * foot posture index score between 6 to 12 exclusion criteria: * history of injuries of the lower extremity within the past 6 months * experience of use of orthopedic insole within the past 6 months * acute disorders in the lower extremities and spine * history of surgery on the lower extremities and lumbar spine within the past 6 months
effect of attention training or ssris on symptoms and neural activation in social anxiety

Conditions: Social Anxiety Disorder

Summary: the purpose of this study is to determine the clinical efficacy and neuro-cognitive mechanisms of gaze-contingent usic reward therapy for social anxiety disorder, compared with treatment with ssris or waitlist control.

attention biases in threat processing have been assigned a prominent role in the etiology and maintenance of anxiety disorders. the purpose of this study is to determine whether giving gaze-contingent feedback is an effective treatment for social anxiety disorder, compared to treatment with ssri (escitelopram) and a waitlist control. a secondary purpose is to explore the unique neuro-cognitive mechanisms of this treatment, using eye-tracking, mri and fmri measurements. participants will be assessed using clinical interviews and self-rated questionnaires before, during and after 12 weeks of treatment or wait. outcome measures will be social anxiety symptoms, as well as dwell time on threat in eye-tracking paradigms tested in previous studies, and bold signals in mri measurements. neuro-cognitive mechanisms will be explored as potential mediators of clinical efficacy.

Eligibility criteria:
inclusion criteria: * a signed consent form * men and women between the ages of 18 and 65. * meeting a current diagnosis of social anxiety disorder (sp) according to the dsm-iv. * sp as the primary diagnosis: in cases of co-morbidity, sp will be deemed as the most distressing and clinically significant condition among the co-morbid disorders. * no current pharmaco-therapy. exclusion criteria: * a diagnosis of psychotic or bipolar disorders. * a diagnosis of a neurological disorder (i.e., epilepsy, brain injury). * drug or alcohol abuse. * any current pharmacological treatment. * any current psychotherapeutic treatment. * change in treatment during the study. * poor judgment capacity (i.e., children under 18 and special populations).
real world study on the efficacy and safety of anti-her2 therapy

Conditions: Breast Neoplasms; HER2-positive Breast Cancer

Summary: anti her2 therapy can improve the survival of her2 positive patients and reduce mortality. the aim of the open-label, real-world study is to assess efficacy and safety of anti-her2 treatment drugs.

about 30% of breast cancer is human epidermal growth factor receptor-2 (her2) amplification or overexpression (i.e. her2 positive). her2 positive breast cancer is one of the indicators of poor prognosis because of its high risk of invasion and metastasis. anti her2 therapy can improve the survival of her2 positive patients and reduce mortality. the aim of the open-label, real-world study is to assess efficacy and safety of anti-her2 treatment drugs including antibody drugs such as trastuzumab and pertuzumab, small-molecule tyrosine kinase inhibitors (tkis) such as lapatinib, neratinib, and pyrotinib, and antibody-drug conjugates such as trastuzumab deruxtecan (ds-8201) and trastuzumab emtansine (t-dm1).

Eligibility criteria:
inclusion criteria: * age ≥ 18 years old, voluntary consent and signed written informed consent. * ecog 0\~2. * diagnosis of locally advanced (stage iiib or iiic) or metastatic (stage iv) breast cancer. * at least one measurable disease lesion before treatment. * anticipated survival time is longer than three months. * pathological and ihc reports for er, pr, her2 and ki67 are available. * for women with fertility, the pregnancy test before administration was negative, and agreed to take appropriate measures to avoid pregnancy during the study treatment and at least half a year after the end of treatment * there are traceable medical records during treatment. exclusion criteria: * pregnant or lactating women. active infection requiring systemic treatment。 * hiv positive * suffering from or suspected of suffering from central nervous system diseases. * serious heart disease. * pulmonary lymphatic involvement leads to pulmonary dysfunction and requires active treatment, including the use of oxygen * the investigator considered that the patient was not suitable for in this study, with any other situation.
a trial of gs-9219 in chronic lymphocytic leukemia (cll), non-hodgkin's lymphoma (nhl) or multiple myeloma (mm)

Conditions: Non-Hodgkin's Lymphoma; Chronic Lymphocytic Leukemia; Multiple Myeloma

Summary: multi-center, open-label, single-dose, dose-escalating phase i/ii study of gs 9219 in adult patients with relapsed or refractory cll, nhl or mm. patients will be enrolled into the study in sequential dose cohorts. patients will be administered a single iv infusion of gs 9219 on day 1 of a 21 day cycle and may receive a total of six treatment cycles based on toxicities and response. patients who demonstrate disease progression will be discontinued from the study. patients who, at the completion of six treatment cycles, tolerate treatment and show evidence of disease control (response or stabilization) will be eligible to continue receiving treatment at the same dose.

the primary objective of this study is as follows: to assess the safety, toxicity, and maximum tolerated dose (mtd) of gs 9219 administered via iv administration once every three weeks (21 days) for six treatment cycles, i.e. for a total of 18 weeks, in patients with relapsed or refractory chronic lymphocytic leukemia (cll), non-hodgkin's lymphoma (nhl) or multiple myeloma (mm). the secondary objectives of this study are as follows: to determine the pharmacokinetic parameters of gs 9219 for this regimen and patient population. to assess the antitumor activity of gs 9219 based on response rate and duration of response. progression-free survival and overall survival will be assessed if applicable.

Eligibility criteria:
inclusion criteria: * relapsed or refractory cll, nhl or mm * ecog performance status of 0, 1, or 2 * adequate organ function (protocol defined) * ecg without evidence of clinically significant ventricular arrhythmias exclusion criteria: * aids-related lymphoma * subjects with nhl who present exclusively with non-measurable lesions * subjects with mm who have non-secretory and/or non-measurable disease * recent anticancer therapy (chemotherapy, radiotherapy, and/or biotherapy)within four weeks prior to starting treatment * evidence of pulmonary fibrosis * other concurrent malignancy * uncontrolled concurrent illness * receiving chronic, systemically administered steroids * known hypersensitivity to nucleoside analogues

Keywords: hematologic malignancies cll nhl chronic lymphocytic leukemia non-hodgkin's lymphoma cll and nhl multiple myeloma mm
effect of a 16-day hot and cold acclimation on adaptive responses and health-related indicators

Conditions: Healthy

Summary: there are no previous studies of the effects of a combination of whole-body immersions in hot and cold baths on adaptive responses and health-related markers. thus, the primary aim of this project is to determine whether interventions consisting of whole body immersion in hot and cold baths over 16 days develop heat and/or cold adaptation by remodeling thermoregulatory, metabolic, cardiovascular and physiological responses, and the secondary aim is to determine if current cold-hot acclimation has any effects on physical and mental health-related markers.


Eligibility criteria:
inclusion criteria: * young, healthy, non-obese males and females; * nonsmoker; * no needle phobia; * not taking medication and/or dietary supplements that may affect experimental variables. exclusion criteria: * neurological, cardiovascular, metabolic, and/or inflammatory diseases, or conditions that could be worsened by exposure to acute thermal stimuli and that could affect experimental variables; * involvement in temperature manipulation program for ≥ 3 months; * attendance at any excessive formal physical exercise or sports program.
fornix and nbm as targets of stimulation in alzheimer's disease

Conditions: Alzheimer Disease

Summary: the primary goal of this study is to evaluate the efficacy and safety of the dbs to the fornix/nbm among patients who are diagnosed as ad according to a series of evaluations including cerebrospinal fluid (csf) biomarkers and molecular imaging examinations; the secondary goal is to compare the efficacy among the two treatment groups of different targets.


Eligibility criteria:
inclusion criteria: 1. subjects with informed consent; 2. 45-75 years of age; 3. at least 6 years of education; 4. ad according to the national institute on aging and the alzheimer's association (nia-aa) guidelines (mckhann et al., 2011); 5. clinical dementia rating scale (cdr): 1.0-2.0; 6. positive findings with amyloid pet imaging; 7. stable prescription of donepezil (5mg, qd) for at least 3 months, and without any intentions to modify the dosage during the observation period. exclusion criteria: 1. fazekas scale\>2; 2. neuropsychiatric inventory (npi) total score ≥10, or any subdomain≥4； 3. modified hachinski ischemic score\>4； 4. young mania rating scale\>11(young, biggs, ziegler, \& meyer, 1978); 5. any suicidal tendencies in recent 2 years; 6. cornell scale for depression and dementia\>10; 7. familial ad; 8. abnormal brain structural magnetic resonance imaging (mri) scan, including hydrocephalus, stroke, structural lesions, etc. that would potentially confound the outcome; 9. surgical history of the central nervous system; 10. severe cardiovascular/pulmonary disorders.
appetite response to exercise- versus mixed (exercise + dietary restriction)-induced energy deficit in adolescents with obesity

Conditions: Pediatric Obesity

Summary: the aim of the present study is to compare the effect of iso-energetic energy deficits induced by energy restriction alone or exercise + dietary restriction (mixed deficit) on energy intake and appetite feelings in adolescents with obesity.

the present study will compare the nutritional response to an energy deficit of 500 kcal induced once by dietary restriction alone and once by a mixed deficit (50% by exercise and 50% by dietary restriction) (compared with a control condition). 18 adolescents with obesity will be asked to randomly complete three experimental sessions: i) one control session (con); ii) one session with a dietary-induced energy deficit (def-ei); iii) one session with a mixed deficit (50% by exercise and 50% by dietary restriction) (def-mixed). their ad libitum energy intake will be assessed at dinner time. appetite feelings will be assessed at regular intervals and their food reward in response to the lunch will also be assessed.

Eligibility criteria:
inclusion criteria: * bmi percentile \> 97th percentile according to the french curves. * ages 12-16 years old * signed consent form * being registered in the national social security system * no contraindication to physical activity exclusion criteria: * previous surgical interventions that is considered as non-compatible with the study. * diabetes * weight loss during the last 6 months * cardiovascular disease or risks

Keywords: appetite control obesity adolescents exercise energy deficit
comparison of ultrasound-guided quadratus lumborum plane block versus intraperitoneal and periportal bupivacaine infiltration in postoperative analgesia after laparoscopic cholecystectomy

Conditions: Quadratus Lumborum; Laparoscopic Cholecystectomy; Ultrasound Guided; Post Operative Analgesia

Summary: the primary outcome: is measured by pain at rest and upon mobilization according to vas. vas for pain (ranging from 0 to 10, where 0 no pain and 10 maximum pain) will be evaluated postoperatively and every 2 hours during the first 6 hours and then every 6 hours for 24 hours postoperatively.

since the concept of day case surgeries is getting more popular, surgeons and anesthesiologists are trying their best to provide adequate post-operative analgesia. the proper management of post-operative pain ensures early ambulation of patients and obviates many post-operative complications. the most common modality for post-operative pain management has remained the parenteral use of non-steroidal anti-inflammatory drugs (nsaids) and opioids. intraperitoneal and periportal infiltration with local anesthetic agents has also remained a popular method to take care of immediate postoperative pain. this technique is virtually cost-free, rapid, and hardly requires any special technical experience or equipment for its use. but as there are advances in anesthetic techniques, more and more regional blocks are being tried to take care of post-operative pain. the choice of anaesthetic block technique depends upon the site of surgical incision proposed. quadratus lumborum (ql) block is a posterior abdominal wall block which permits the spread of local anesthetic agent behind the quadratus lumborum muscle into a triangular space known as a lumbar interfacial triangle, which lies beside the middle layer of the thoracolumbar fascia. this interfacial plane is in adjoining proximity with numerous sympathetic fibers and conjoin with the thoracic paravertebral space, thus preceding to a long-standing block with the capability to provide visceral analgesia (kadam, 2013).

Eligibility criteria:
inclusion criteria: * age 21-60 years of both sexes. * elective laparoscopic cholecystectomy under general anesthesia. * physical status: asa i and ii patients after taking written and informed consent. exclusion criteria: * • refusal of procedure or participation in the study by patients. * physical status: asa iii or above. * infection at site of injection. * psychiatric illness that leads to inability to cooperate, speak or read. * daily use of opioids. * history or evidence of coagulopathy especially if inr\>1.5 and platelet \<100.000 * allergies to drugs used (bupivacaine 0.5%).

Keywords: quadratus lumborum plane block, intraperitoneal and periportal bupivacaine infiltration, post operative analgesia, laparoscopic cholecystectomy
prospective clinical study evaluating tibiofemoral rotational alignment using intraoperative sensing during total knee arthroplasty (tka)

Conditions: Osteoarthritis

Summary: the objectives of the study are twofold: 1) evaluate how intra-operative sensing may assist the surgeon with tibiofemoral rotational alignment by testing the precision and variability of setting tray rotation to the mid-third of the tibial tubercle. 2) understand if patients with a combined axial rotation couple at the tibiofemoral joint and quantitative intercompartmental balance, achieved with the use of verasense, exhibit less post-operative knee pain and improved clinical outcomes. radiographic outcomes will also be assessed to measure post-operative alignment and to evaluate the prevalence and location of radiolucency and/or osteolysis.

hypothesis: tka with verasense results in a more reliable and precise option for establishing implant-to-implant congruency and joint balance leading to less knee pain, faster return to normal activities and higher patient satisfaction compared to tka without verasense.

Eligibility criteria:
inclusion criteria: * patients who meet the indications for use for triathlon® total knee system using verasense™ * subject must be diagnosed with one or more of the following conditions * osteoarthritis * rheumatoid or other inflammatory arthritis * post-traumatic arthritis * subject is likely to be available for all study visits * subject is able and willing to sign the informed consent and follow study procedures exclusion criteria: * prior total knee arthroplasty * avascular necrosis * any knee surgery other than meniscectomy (can be arthroscopic or open) * ligament insufficiencies, prior surgeries such as anterior cruciate ligament (acl) or pcl reconstructions, posterolateral reconstructions, osteotomies, tibia plateau fractures * ipsilateral foot/ankle and hip arthritis * range of motion less than 90°, flexion contracture greater than 20° * subject has a mental condition that may interfere with the subject's ability to give an informed consent or willingness to fulfill the study requirements (i.e., severe mental retardation such that the subject cannot understand the informed consent process, global dementia, prior strokes that interfere with the subject's cognitive abilities, senile dementia, and alzheimer's disease) * any subjects meeting any contraindication criteria as identified in the locally approved labeling for the device should be excluded from this study.

Keywords: total knee arthroplasty rotational alignment intraoperative sensors patient outcomes soft tissue balance
study of tumor samples in patients undergoing radiation therapy or surgery for primary melanoma of the eye

Conditions: Intraocular Melanoma

Summary: rationale: studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in dna and identify biomarkers related to cancer. purpose: this clinical trial is studying tumor samples in patients undergoing surgery or radiation therapy for primary melanoma of the eye.

objectives: primary * to establish the feasibility of using fine needle aspiration (fna) and fish to determine tumor genotype in patients with primary uveal melanoma. secondary * to characterize ophthalmic complication rate of fna for fish analysis in patients undergoing plaque radiotherapy. * to estimate disease-free survival in patients with and without tumor monosomy 3 and/or 8q amplification. * to explore the relationship between tumor monosomy 3 and 8q amplification and plasma levels of tumor immune escape and invasion biomarkers (e.g., circulating granulysin, beta2-microglobulin, autotoxin, lysophosphatidic acid, matrix metalloproteinase-7, tissue inhibitor of matrix metalloproteinase, and soluble e- cadherin). * to explore the psychological impact of prognostication in uveal melanoma. outline: patients undergo plaque radiotherapy, enucleation, or tumor resection based upon standard of care guidelines. trans-scleral fine needle aspiration (fna) is performed at the time of plaque radiotherapy and ex vivo fna is performed on enucleation and tumor resection specimens. tissue samples are analyzed by fluorescence in situ hybridization (fish). blood samples are also collected for further analysis. after completion of study therapy, patients are followed up periodically.

Eligibility criteria:
inclusion criteria * patients must have a clinical diagnosis of melanoma of the iris, ciliary body and/or choroids * patients must have had a hepatic ultrasound and/or other suitable imaging studies to eliminate metastatic disease * patients must not have received any local or systemic therapy for uveal melanoma * all patients must be informed of the investigational nature of this study and must provide written informed consent in accordance with institutional and federal guidelines. a copy of the informed consent document signed by the patient must be given to the patient * patients must have the following pretreatment laboratory findings: * bilirubin (total) \</= 1.5 ml/dl * ast \</= 2 x normal * alt \</= 2 x normal * alkaline phosphatase \</= 2 x normal exclusion criteria * patients with metastasis * patients under the age of 18

Keywords: ciliary body and choroid melanoma, small size iris melanoma intraocular melanoma ciliary body and choroid melanoma, medium/large size