Kornimate/medical-research-clean huggingface dataset:
study comparing venlafaxine vs. paroxetine in panic disorder

Conditions: Panic Disorders

Summary: the purpose of this pilot study is to evaluate the improvement in social function following therapy with venlafaxine extended release (xr) in the treatment of panic disorder (pd) in comparison to paroxetine. an additional purpose of this pilot study is to obtain the tolerability of using venlafaxine extended release (xr) in the treatment of panic disorder (pd) in comparison to paroxetine.


Eligibility criteria:
inclusion criteria: * meet dsm iv criteria for panic disorder (with or without agoraphobia) for at least 3 months before study day 1. * have a minimum of 8 full-symptom panic attacks during the 4 weeks before the screening visit. * provide a written informed consent exclusion criteria: * treatment with venlafaxine within 6 months of study day 1, as well paroxetine * known hypersensitivity to venlafaxine or related compounds as well to paroxetine. * psychopharmacologic drugs within 14 days of study day 1

Keywords: panic disorders
changes in lumbar region temperature during auricular acupressure at kidney point

Conditions: Temperature Change, Body

Summary: in traditional medicine, auricular acupressure (aa) is one of the non-pharmacological treatment methods commonly utilized due to its safety and convenience. aa involves the application of a taped seed of vaccaria (with a diameter of 2mm) on specific ear acupoints to manage various disorders. among these, chronic lower back pain is prevalent. according to traditional medicine, the kidney point is selected for this condition due to the belief that "the lumbar region is the house of the kidneys". however, evidence supporting this correlation is still lacking. in this study, the aim is to assess the relationship between the kidney point and the lumbar region by monitoring changes in skin temperature through the application of aa on this acupoint.

healthy volunteers meeting all selection criteria and not violating exclusion criteria will be recruited for the study. before commencement, participants will acclimate to the environment for 15 minutes, allowing stabilization of blood pressure, heart rate, respiratory rate, and body temperature. the room will be enclosed and shielded, ensuring no direct sunlight or other radiation sources enter. room temperature, pressure, humidity, and ventilation will be consistently maintained throughout the study. the participants will be randomly divided into two groups: one receiving auricular acupressure (aa) first followed by sham auricular acupressure (sa) (aa-sa group), while the other group will receive sa first followed by aa (sa-aa group). blood pressure, heart rate, respiratory rate, body temperature, lumbar region temperature, and side effects of auricular therapies will be continuously monitored.

Eligibility criteria:
inclusion criteria: * bmi between 18.5 and 23 kg/m2. * demonstrates alertness and cooperativeness. * vital signs within normal limits. * voluntary informed consent. exclusion criteria: * anxiety, depression, or stress based on the depression anxiety and stress scales 21 (dass-21). * presence of disorders or use of medications affecting body temperature. * received any form of heat therapy for the lower back within the past week (e.g., acupuncture, heat pads, patches, massage). * applied chemical or pharmaceutical products to the skin area under investigation prior to the study. * current disorders or pathologies in the lumbar region. * engaged in nighttime activities or experienced insomnia the night before the research day. * participated in sports activities within 2 hours before the study. * used stimulants within 24 hours prior. * history of alcohol or substance addiction. * history of hypersensitivity reactions to any form of acupuncture. * existing injuries or lesions at acupoints and areas investigated in this study. * women currently menstruating, pregnant, or breastfeeding. * prior experience with auricular therapies. * currently participating in other intervention studies.
real-world registry of the rotarex(tm) rotational excisional atherectomy system (xtract registry)

Conditions: Peripheral Arterial Disease(PAD)

Summary: the xtract registry is a prospective, single arm multicenter study on the use of on the rotarex(tm) rotational excisional atherectomy system.

the study will recruit approximately 600 subjects treated for pad.

Eligibility criteria:
inclusion criteria: 1. subject or legally authorized representative provides written informed consent using an informed consent form (icf) that is reviewed and approved by the irb for the site. 2. subject is ≥22 years old at the time of signing the informed consent. 3. subject must have a lesion(s) in their infra-inguinal peripheral arteries that can be treated with the rotarextm rotational excisional atherectomy system according to instructions for use (ifu). 4. rutherford 2-5 for chronic limb ischemia and rutherford i to iib for acute limb ischemia. 5. target lesion can be crossed intra-luminally by guidewire. 6. at least one patent native outflow artery to the foot, free from significant stenosis(≥50% stenosis as confirmed by angiography) (chli cohort only, not applicable to ali cohort). exclusion criteria: 1. subject is unable or unwilling to comply with follow-up procedures and visits. 2. subject has a target lesion in a vessel with less than 3 mm in diameter. 3. subject is participating in another device or drug clinical trial that interferes with this protocol and confounds results. 4. treatment plan includes use of a thrombectomy and/or atherectomy device other than rotarextm rotational excisional atherectomy system. 5. life expectancy is below 1 year. 6. pregnant, planning to become pregnant during the course of the study or nursing a child.

Keywords: rotarex pad
apoptotic changes in gingiva caused by smoking

Conditions: Smoking; Chronic Periodontitis

Summary: smoking is a major environmental risk factor associated with common forms of human chronic periodontitis. the aim of the present study was to evaluate apoptotic tissue alterations and tissue destruction in smoker and non-smoker chronic periodontitis patients and healthy individuals. the investigators of the study suggest that smoking decrease tissue quality and increase inflammation level in gingival tissues in both healthy individuals and periodontitis patients. one possible mechanism for this is suggested to be increased apoptosis.

periodontal disease disrupts soft tissue metabolism in the gingiva through a decrease in the production of collagen, the quality, and quantity of the connective tissue. the etiology and pathogenesis of chronic periodontitis are mostly revealed, however, the mechanism of environmental factors such as smoking yet to be clarified. major consequences of smoking in gingival tissues are suggested to be the reduction in neutrophil and fibroblast function, decreased immunoglobulin g production, increased periodontal pathogen bacteria prevalence, difficulty in eliminating pathogens with mechanical therapy, and reduction in growth factor production. in the present study, markers of tissue destruction, matrix metalloproteinase-8 and tissue inhibitor of matrix metalloproteinase-1, hypoxia markers, vascular endothelial growth factor and hypoxia-inducible factor and apoptotic markers, bax, bcl-2, and caspase-3 were evaluated.

Eligibility criteria:
inclusion criteria: * age range from 30 to 45, * the existence of at least 20 functioning teeth, * systemical health, * no antibiotic use within 6 months, * no periodontal therapy within 6 months, * no pregnancy or lactation, * no drug use, in addition; for the smokers existence of the smoking condition for at least five years. exclusion criteria: * patients younger than 30 older than 50 years old, * the absence of occlusion, * drug use, * pregnancy/lactation, * previous antibiotic use, * previous periodontal therapy, * the existence of any systemical disease.

Keywords: smoking hypoxia apoptosis chronic periodontitis
efficacy and safety of hrs9531 injections in overweight or obese subjects

Conditions: Overweight or Obesity

Summary: to assess the efficacy of hrs9531 injection compared with placebo in weight reduction in overweight or obese subjects after 36 weeks of treatment.


Eligibility criteria:
inclusion criteria: 1. able and willing to provide a written informed consent. 2. male or female subjects, 18-65 years of age at the time of signing informed consent. 3. 28.0 ≤bmi≤ 40.0 kg/m2 or 24 ≤bmi\< 28.0 kg/m2 with at least 1 weight-related comorbidity at screening visit. 4. diet and exercise control for at least 3 months before screening visit, and less than 5 kg self-reported change within the last 3 months. exclusion criteria: 1. presence of - clinically significant lab or ecg results that may affect the evaluation of the efficacy or safety of the study drug at screening visit. 2. poor-controlled hypertension. 3. phq-9 score ≥15. 4. medical history of illness that affects weight. 5. history of diabetes. 6. acute infection, acute trauma, or medium to large surgery within 1 month prior to screening. 7. history of acute cardiovascular and cerebrovascular diseases. 8. any organ-system malignancies developed within 5 years except cured local basal cell carcinoma of skin and cervical carcinoma in situ. 9. confirmed or suspected depression, bipolar disorder, suicidal tendency, schizophrenia, or other serious mental illness. 10. history of alcohol , medication or drug abuse within 1 year prior to screening. 11. use of any medication or treatment that may cause significant weight change within 3 months. 12. history of bariatric surgery. 13. subjects participating in qt/qtc studies need to comply with relevant examinations. 14. known or suspected hypersensitivity to trial product(s) or related products. 15. participation in other clinical trials within 3 month prior to screening. 16. history of blood donation or blood loss in the 3 months before screening, or blood transfusion in the 2 months before screening 17. surgery is planned during the trial. 18. mentally incapacitated or speech-impaired. 19. female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method. 20. researchers and relevant staff of the research centre or other people directly involved in the implementation of the programme, and their immediate family members. 21. in the judgment of the investigator, there are circumstances that affect the safety of the subject or any other interference with the evaluation of the test results.
a study of vismodegib with surgery in participants with previously untreated basal cell carcinoma

Conditions: Basal Cell Carcinoma

Summary: this randomized, double-blind, placebo-controlled study will assess the efficacy and safety of vismodegib with surgery in participants with basal cell carcinoma.


Eligibility criteria:
inclusion criteria: * diagnosis of non-infected, not recurrent, previously untreated basal cell carcinoma * free of any significant physical abnormalities (e.g., tattoos) at the target basal cell carcinoma site * willing and able to participate in the study as an outpatient and agreement to make frequent visits to the clinic during the treatment and follow-up periods and to comply with study requirements exclusion criteria: * prior treatment with vismodegib * known hypersensitivity to any of the study drug excipients * any metastatic basal cell carcinoma * any locally advanced basal cell carcinoma considered to be inoperable or to have a medical contraindication to surgery * evidence of clinically significant and unstable diseases or conditions (e.g., cardiovascular, immunosuppressive, hematologic) * any dermatological disease at the target basal cell carcinoma site that may cause difficulty with examination * recent, current, or planned participation in another experimental drug study
clinical and radiographic evaluation of the entire papilla preservation (epp) technique versus modified minimally invasive surgical technique (m-mist) in treatment of intraosseous defects in patients with stage iii periodontitis: a randomized clinical trial

Conditions: Intrabony Periodontal Defect

Summary: periodontitis is defined as loss of periodontal attachment due to microbial associated host mediated inflammation. this would lead to the apical migration of the junctional epithelium allowing the bacterial biofilm to undergo apical widespread along the root surfaces of teeth causing bone resorption (tonetti, greenwell, \& kornman, 2018). the main objective of periodontal surgeries is directed at complete preservation of the interdental soft tissues to achieve primary closure over the intraosseous defected sites during the early phases of wound healing. evidence shows that surgical techniques are highly predictable in the treatment of pockets associated with deep and shallow intrabony defects affected majorly by the selected flap design. the purpose of the flap design of minimally invasive periodontal surgery is to overcome the drawbacks of conventional periodontal surgeries decreasing the surgical trauma, improving the clot stability, reducing patient discomfort post operatively and minimizing the surgical chair time (aslan, buduneli, \& cortellini, 2017b) modified minimally invasive surgical technique (m-mist) is considered one of the latest minimally invasive techniques that have been used in the treatment of intraosseous defects, this technique however entails an incision over the defect-associated interdental papilla that may jeopardize the volume and complex vascular integrity of the interdental tissues, lacking the special flap design that would emphasis clot stability for better wound healing. where a new surgical technique turned entire papilla preservation has been developed for protection of the wound without affecting the vascularity of the area. (pierpaolo cortellini \& tonetti, 2015) this randomized clinical trial compared the clinical and radiographic efficacy of entire papilla preservation surgical technique (epp) to modified minimally invasive surgical technique (m-mist) in the treatment of periodontal intraosseous defects in stage iii periodontitis patients.


Eligibility criteria:
inclusion criteria: * patients age between 20 and 60 years old. * stage iii periodontitis patient having 2 or 3 walled or combined 2 and 3 walled intraosseous defect ≥ 3 mm deep (assessed by trans-gingival probing, radiographic examination) with clinical attachment level (cal) ≥ 5mm and pocket depth (pd) ≥ 6 mm. * defect not extending to a root furcation area. * vital teeth * no history of intake of antibiotics or other medications affecting the periodontium in the previous 6 months. * patients who are cooperative, motivated, and hygiene conscious. exclusion criteria: * any systemic disease that contra-indicates periodontal surgery or may affect healing. * smokers * pregnant females * drug abusers
evaluation of maxillary and mandibulary nerve blocks on morphine consumption

Conditions: Dento Facial Dysmorphism

Summary: background and objectives: double-jaw surgery is one of the most painful oral surgery, requiring multimodal analgesia including controlled morphine pump and its secondary effects. the aim of this study was to evaluate the effectiveness of face block (mandibulary and maxillary block analgesia) on the first 24 hours on morphine consumption in patients admitted for double jaw surgery.

methods: patients undergoing double-jaw surgery between january 2015 and may 2017 were enrolled. patients were separated into 2 groups: patients receiving maxillary-mandibulary nerve block and those no receiving it. the primary endpoint was the morphine consumption within 24 hours post-surgery. secondary endpoints were the intra-operative remifentanil consumption, incidence of postoperative nausea and vomiting at 24 hours, morphine consumption in recovery room, length of stay in hospital.

Eligibility criteria:
inclusion criteria: - male and female who underwent double jaw surgery exclusion criteria: * opposition to the study * an additional surgical procedure * preoperative consumption of morphine or derived from morphine * perioperative n20
remifentanil versus paracetamol for pain treatment external cephalic versions.

Conditions: Breech Presentation; Pregnancy

Summary: background: between 3-4% of pregnancies carried to term, the fetuses are in breech presentation. the external version is a maneuver gynecological used to turn a breech in cephalic presentation. for treatment of pain suggests the use of μ agonist remifentanil for fast action and elimination. objective: to compare the effectiveness of remifentanil for pain management in external version. patients: pregnant for 36 weeks or more with breech presentation who met the inclusion criteria and sign the consent. participants will be randomized into two groups before the procedure. group intervention: paracetamol and remifentanil control group: paracetamol and placebo determinations: vas pain level, percentage of success of the maneuver and adverse events. statistical analysis: comparison of pain recorded by vas in both groups and comparison of adverse events


Eligibility criteria:
inclusion criteria: * fetuses between weeks 36 and 41 of gestation confirmed by ultrasound with non-cephalic presentation. * informed consent signed by the mother or legal representative in his absence. exclusion criteria: * fetal anomalies * severe hypertension * allergy to drug used in the test * amniotic fluid index ≥ 5 cm * contraindication for vaginal delivery * uterine abnormality and impaired coagulation * placenta previa * rh sensitization * multiple gestation * ruptured membranes * premature detachment of normally inserted placenta * the mother greater weight to 85kg

Keywords: ceophalic version breech presentation pregnancy remifentanil paracetamol
efficacy of copper to reduce acquisition of microbes and healthcare-acquired infections

Conditions: Healthcare-acquired Infection

Summary: context: healthcare-acquired infections (hai) cause substantial patient morbidity and mortality. commonly touched items in the patient care environment harbor microorganisms that may contribute to hai risk. thus, reduction in the surface bioburden may be an effective strategy to reduce hai. inherent biocidal capabilities of copper surfaces offer a theoretical advantage to conventional cleaning, as disinfection is continuous rather than episodic. objective: determine whether placement of copper-alloy surfaced objects in an intensive care unit (icu) reduce risk of hai. design: an intention to treat study where patients are sequentially placed into rooms with or without copper-alloy surfaced objects. setting: the icus of three hospitals, a tertiary academic hospital, an academic cancer center, and a veteran's administration medical center. patients: any patient 18 years of age or older who required admission to an icu at a study hospital is eligible for placement into a study room if available. intervention: placement of copper-alloy surfaced objects in an icu room. main outcome measure: rate of incident hai and/or colonization with methicillin-resistant staphylococcus aureus (mrsa) or vancomycin-resistant enterococcus (vre) in each type of room.


Eligibility criteria:
inclusion criteria: patients 18 years and older requiring admission to an icu at one of the study sites were eligible exclusion criteria: * less than 18 years of age or * pregnant

Keywords: healthcare-acquired infections colonization copper-alloy surfaces
nutritional supplementation in sarcopenic obesity

Conditions: Sarcopenic Obesity

Summary: the obese patient presents a quantitative and qualitative deficit of muscle mass as occurs in the elderly subject that was named sarcopenic obesity (so). the use of a diet that includes protein supplements and / or essential amino acids seems to improve this condition in the elderly; there are no similar studies in obese subjects, in particular during a low-calorie diet and physical activity program that can produce further loss of muscle mass. this study aims to verify whether the administration of these supplements (protein or amino acid) in the obese patient are effective in improving anthropometric and functional parameters and some serum markers of muscle metabolism. the results obtained could represent new therapeutic protocols in the treatment of obesity.

several studies have confirmed that adequate nutrition, especially protein intake, including at breakfast, or supplementation with amino acids, in association with adequate physical activity plays an important role in the treatment of so. the supplementation of protein or amino acid preparations (in particular with the 9 essential amino acids including, the branched - leucine, isoleucine, valine), marketed in different formulations, has already allowed to document a significant therapeutic efficacy in the treatment of elderly sarcopenic subjects. in fact, the use of these preparations improves physical performance and muscle strength by inducing the synthesis of proteins involved in the biogenesis and functionality of mitochondria - that is, the cellular organelles responsible for the production of energy in the form of atp - and of myofibrillar proteins (which constitute the large percentage of muscle mass), both in laboratory animals and in humans.

Eligibility criteria:
inclusion criteria: * patients with obesity (bmi\> 35kg / m2) * sarcopenia (criteria described in coltorti a et al). exclusion criteria: * renal insufficiency * diabetes * muscular pathologies * neurological-neurodegenerative pathologies * cognitive decline
navigation surgery for bone and soft tissue tumor

Conditions: Bone Tumors

Summary: bone tumor near the articular cartilage is hard to remove sufficiently without damaging adjacent joint. the purpose of this study was to evaluate the feasibility of navigation-assisted surgery for saving joint in bone tumor resection or curettage. in this study, the investigators hypothesized that computer-assisted surgery is feasible method to get both enough margin and joint salvage. each of them is important intermediate factor for either oncologic outcome or functional outcome respectively. the investigators designed this study to find what proportion of patients who underwent computer-assisted resection could get enough margins using some criteria obtained by overlapping preoperative and postoperative images. the investigators also evaluated whether computer-assisted surgery can be feasible for joint saving using some criteria including functional outcome.


Eligibility criteria:
inclusion criteria: 1. first condition is that the benign tumor is located deeply in bones of extremities, or pelvis, so we anticipate the difficulty to find the tumor and to assess the adequacy of resection without the aid of computer-assisted navigation during operation. 2. second condition is when the violation of joint or growth plate is expected during removal of tumor due to its close proximity to joint or growth plate. in case of malignant bone tumor, the sufficient preservation of joint anatomy should be required even with resection margin of 1.5 cm away from reactive zone of tumor. the sufficient preservation of joint is defined when at least 1 cm subchondral bone is remained after tumor resection, because 1 cm subchondral bone is required for fixation with allograft in subsequent reconstruction. the sufficient preservation of joint is also defined when articular surface is removed, but more than 50% of articular surface has to be saved. exclusion criteria were 1. patients who denied to perform navigation surgery after explanation of navigation surgery protocol 2. medically high-risk patients who could not withstand long surgical time for joint reconstruction 3. patients whose feasibility of joint preservation was not fulfill the above inclusion criteria at initial presentation, although the tumor size was decreased enough to fulfill the inclusion criteria in mri after completion of neoadjuvant chemotherapy.

Keywords: computer-assisted surgery bone tumor we will evaluate whether computer-assisted surgery will be feasible and safe for bone tumor resection