Kornimate/medical-research-clean huggingface dataset:
the effect of mechanical vibration and helfer skin tap technique on procedural pain in infants during vaccination

Conditions: Procedural Pain; Nursing Caries; Pain, Acute

Summary: this study will be conducted to determine the effect of mechanical vibration and helfer skin tap technique applied during intramuscular vaccinations on procedural pain level, crying time and procedure time in healthy infants.

vaccination is one of the painful procedures routinely performed in infants. the pain experienced by the infant negatively affects the prognosis of the disease, the infant's behavior, the harmony with the environment, the development of the brain and senses, as well as the family infant interaction. nonpharmacologic methods have been found to be effective in alleviating pain during interventions that cause pain caused by medical procedures that infants frequently encounter. mechanical vibration and helfer skin tap technique are effective methods that can be used in nonpharmacologic procedural pain management. studies have commonly used parent-related methods (kangaroo care, mother/ father cuddling, breastfeeding, etc.) for neonatal pain management during vaccine administrations. in units where access to the parent is not always possible, nonpharmacologic pain methods that can be used independently of the parent can be used in the management of needle related acute pain. in addition, no study was found in the literature comparing the effect of mechanical vibration and helfer skin tap technique on hepatitis b and dtap-ipv-hib vaccinations-related pain. this study will be investigated the effects of mechanical vibration and helfer skin tap technique methods on procedural pain, crying time and duration of the procedure during intramuscular vaccinations in healthy term infants.

Eligibility criteria:
inclusion criteria: * healthy term infants * born at 38-42 weeks gestational week, * birth weight 2500-4400 g, * in stable health, * able to carry out vital activities without support, * babies ordered third dose hepatitis b vaccine by the doctor exclusion criteria: * with a genetic or congenital anomaly, * neurological, cardiological and metabolic diseases, * in need of respiratory support, * acute or chronic illness that causes pain, * a complication of childbirth, * nerve damage or deformity in the extremity to be vaccinated, scar tissue or incision in the vastus lateralis region.

Keywords: healthy infant nonpharmacological pain management procedural pain
gh and cardiovascular risk factors

Conditions: Growth Hormone Deficiency; Cardiovascular Diseases; Metabolic Syndrome; Cognition; Physical Activity

Summary: rationale: abnormally low and high levels of insulin-like growth factor-i (igf-i) are both associated with increased metabolic risk. since (u-shaped) associations of igf-i, within the normal range, have also been found with cardiovascular risk factors and disease in the general population, it would be interesting to investigate if this association can also be found in growth hormone deficient (ghd) adults treated with growth hormone (gh). this could be of interest for endocrinologists prescribing gh in clinical practice because strict dosing may become even more important. next to that, scientific evidence for clinical practice is wanted. objective: next to cardiovascular risk factors (main objectives: body composition and lipid profile; secondary objectives: remainder) we investigate the effect on glucose metabolism, physical performance, and neuropsychological functioning of different levels of igf-i in gh treated ghd men and women. study design: open-label randomized trial. study population: at least 32 subjects, both childhood as adult onset ghd men and women, receiving gh treatment for at least one year, with an age between 20 and 65 years. intervention: at entry subjects are already receiving gh treatment according to general clinical practice, and are expected to demonstrate an igf-i concentration of 0 - 1 sd score (sds) (normal dose). the group of men and group of women will be randomized to receive either a decrease of their regular dose of gh treatment (igf-i target level of -2 - -1 sds) (low dose), or an increase of their regular dose, (igf-i target level of 1 - 2 sds) (high dose) for at least 24 weeks.


Eligibility criteria:
inclusion criteria: * ongoing surveillance at our centre (vumc) * stable substitution therapy for other pituitary hormone deficiencies exclusion criteria: * subjects with a craniopharyngioma as cause of their ghd or pituitary deficiencies * contraindications for the use of gh treatment * (receiving treatment for) malignant disease (in the past) * cardiovascular event less than one year prior to inclusion * participation in other studies * subjects, who in the opinion of the investigator, are unsuitable in any other way to participate in this study
inflammation in vascular disease

Conditions: Vascular Diseases; Atherosclerosis

Summary: increasing evidence suggests that systemic low-grade inflammation may be a driving force of cardiometabolic complications, such as vascular dysfunction, atherosclerosis and ischemic heart disease. thus, we will investigate the role of inflammation in cardiovascular disease.

vascular reconstruction surgeries usually require a small piece of the vessel wall to be excised. the excised vessel is generally discarded as medical waste: however, for patients participating in the study, the excised tissue will be placed in saline and collected for research use. tissue collected from individuals undergoing vascular surgery associated with peripheral arterial diseases, aneurysm and/or other manifestations of atherosclerosis, vascular tissue will be cultured ex vivo in the presence or absence of therapeutic agents, to determine if these attenuate the inflammation associated with the atherosclerotic phenotype. furthermore, the protocol will also be carried out using vascular tissue from control patients, which have undergone vascular surgery that is not associated with vascular disease (e.g. knee replacement surgery, trauma, etc).

Eligibility criteria:
inclusion criteria: * patient is planned to undergo vascular surgery. * signed informed consent has been obtained from the patient. exclusion criteria: * patient has difficulty to understand information. * patients under 18 years of age. * patients participating in any drug-related study.
non-invasive brain stimulation in adults who stutter

Conditions: Stuttering, Developmental

Summary: research studies in stuttering have shown that activity patterns in certain brain areas differ in people who stutter compared to people who do not stutter when speaking. the purpose of this study is to investigate how mild, non-invasive brain stimulation applied consecutively for five days affects speech relevant brain areas, which may in turn affect speech fluency and speaking-related brain activity in people who stutter.


Eligibility criteria:
inclusion criteria: * history of persistent developmental stuttering * stuttering severity ranging from mild to very severe, specifically stuttering severity instrument (ssi) total score of 20 (mild) or higher and stuttering rates of 3% or higher * scores within 1 standard deviation of the norm on the standardized tests for the study exclusion criteria: * received any treatment for stuttering within the past year * other neurological conditions such as tourette's syndrome or post-traumatic stress disorder * taking any medications/drugs that affect brain function * history of past or current mental illness for example, schizophrenia that may affect brain development and function * history of serious medical or neurological illness such as epilepsy and parkinson's disease * history of closed head injury (e.g., concussion) * history of reading disorders * hearing loss * taking any medication, prescription or non-prescription with any psychotropic effects at the time of the study * metal or electronic implants such as cochlear implants, and pacemakers

Keywords: transcranial direct current stimulation mri speech fluency tdcs
nd:yag laser versus diode laser assisted new attachment procedure (lanap) in the management of stage ii periodontitis

Conditions: Periodontitis

Summary: aim of the study was to assess and compare the clinical and microbiological changes following laser assisted new attachment procedure (lanap®) using diode 940 nm versus nd:yag 1064 nm, and to compare the outcome to conventional periodontal therapy


Eligibility criteria:
inclusion criteria: * periodontal diagnosis of stage ii periodontitis. * residual periodontal pocket ≥4 mm, 3-4 mm clinical attachment loss with horizontal bone loss higher than 15% in radiography. * o'leary plaque index \<10%. exclusion criteria: * patients with furcation involvement. * class ii/iii tooth mobility. * smokers who smoke more than 10 cigarettes per day. * patients with any systemic condition possibly affecting the outcome of periodontal therapy. * patients who had received any local or systemic anti-inflammatory medications or antibiotics within the last 6 months. * alcohol consumers. * pregnant or lactating women. * patients with parafunctional habits.
evaluation of a rapid diagnostic device, cl detect, for the diagnosis of cutaneous leishmaniasis in tunisia

Conditions: Skin Diseases, Parasitic

Summary: the purpose of the study is to evaluate the sensitivity and specificity of cl detect, in subjects with suspected cl in tunisia.

subjects were selected based on clinical appearance of the skin lesion characteristics of cutaneous leishmaniasis (cl). study compared the cl detect rapid test vs microscopic identification of leishmania amastigotes in a stained lesion sample. two diagnostic samples were collected from the subjects lesion in the following order: 1) obtained with a dental broach for use with the cl detect rapid test and 2) a second sample was obtained by scraping for use in the microscopic identification of amastigotes. samples were analyzed by microscopy and cl detect repaid test by different operators who evaluated each sample independently blinded to the other assay result.

Eligibility criteria:
inclusion criteria: * at least 18 years of age and generally healthy * subject able to give written informed consent * subject has a lesion suspicious for leishmaniasis that satisfies the following criteria for an index lesion: * less than 4 months in age * primarily ulcerative, ie not purely verrucous or nodular, and does not have clear clinical evidence of cellulitis * in a location suitable for collecting samples by dental broach, scraping, and aspiration * in the opinion of the investigator, the subject is capable of understanding and complying with the protocol exclusion criteria: • received treatment for leishmaniasis within the last 2 months prior to signing consent, with the exception of mercurochrome

Keywords: leishmaniasis, leishmania
iron overload and transient elastography in patients with myelodysplastic syndrome

Conditions: Myelodysplastic Syndrome

Summary: patients with myelodysplastic syndrome (mds) have an ineffective hemopoiesis and often suffer from anemia. this can lead to red blood cell transfusion dependency and iron overload. iron overload can affect the liver and lead to liver fibrosis and worst case cirrhosis. ferritin is usually used to monitor the iron overload. in this study mds patients will have a transient elastography performed which measures the liver's stiffness. the purpose is to investigate whether liver stiffness measurements are coherent to ferritin levels.

transient elastography is noninvasive and has no side effects. no liver biopsy will be performed due to serious side-effects and risks in this patientgroup. the results of the transient elastography will be compared to the patient's ferritin levels and the numbers of months the patients have had mds to find out if there is a correlation. furthermore we will compare the liver stiffness measurements in the patients with higher ferritin levels to those who have lower ferritin levels. we will also compare the liver stiffness measurements in patients who are red blood cell transfusion dependent compared to those who are red blood cell transfusion independent. we will also compare liver stiffness measurements in the patients with a high alanine aminotransferase (alat) compared to those with normal alat.

Eligibility criteria:
inclusion criteria: * patients with a bone marrow describing myelodysplasia among these: * patients with myelodysplastic syndrome (mds) * patients with acute myeloid leukemia (aml) transformed from mds * patients with chronic myelomonocytic leukemia (cmml) with dysplasia * patients with myelodysplastic/myeloproliferative neoplasm, unclassifiable exclusion criteria: body mass index (bmi) of 30 or higher than 30 - history with other known liver diseases among these: * patients with chronic viral hepatitis c infection * patients with chronic viral hepatitis b infection * patients with alcoholic liver cirrhosis
early postoperative complications in patients undergoing bariatric surgery

Conditions: Bariatric Surgery Candidate; Complication,Postoperative

Summary: this study examined immediate postoperative complications in patients undergoing various bariatric surgeries, aiming to evaluate the safety and efficacy of these interventions. conducted at specialized high-volume bariatric surgery centers in tijuana, mexico. predominantly female patients with severe obesity underwent procedures like sleeve gastrectomy and roux-en-y gastric bypass. immediate complications were rare, occurring in only 0.38% of patients, with bleeding being the most common issue. surgical reintervention within 48 hours was required in 0.33% of cases. the study's low complication rate suggests that surgeon expertise is crucial in minimizing risks and improving postoperative outcomes in bariatric surgery.

this study, conducted in specialised high-volume bariatric surgery centres in tijuana, baja california, mexico, aimed to analyze the outcomes of various bariatric surgery procedures. it include patients who underwent surgeries like sleeve gastrectomy, gastric bypass, and others. the surgeries were performed by five specialized surgeons with assistance from ten bariatric surgery subspecialists. the researchers reviewed electronic medical records and excluded patients with incomplete information. postoperative complications requiring additional medical or surgical interventions were noted. statistical analysis was conducted using spss software, focusing on descriptive measures like frequencies, percentages, means, and standard deviations.

Eligibility criteria:
inclusion criteria: * patients aged 18 years and above * varying degrees of overweight or obesity who underwent surgery at the participating hospitals exclusion criteria: * incomplete or insufficient information in their medical records
68ga-fapi-46 pet/ct for predicting histological response in triple-negative breast cancer (fap-it)

Conditions: Triple Negative Breast Cancer

Summary: prospective multicenter study evaluating the prediction of histological response after neoadjuvant pembrolizumab in combination with chemotherapy by pre-treatment 68ga-fapi-46 pet/ct imaging in patients with early-stage high-risk tnbc.

prospective multicenter study evaluating the prediction of histological response of pembrolizumab in combination with neoadjuvant chemotherapy by pre-treatment 68ga-fapi-46 pet/ct imaging in patients with early-stage high-risk tnbc. patients will receive the newly established standard of care of neoadjuvant pembrolizumab 200 mg q3w given with 4 cycles of paclitaxel + carboplatin, then with 4 cycles of doxorubicin or epirubicin + cyclophosphamide. after definitive surgery, patients will receive adjuvant pembrolizumab for 9 cycles or until recurrence or unacceptable toxicity. the 68ga-fapi-46 pet/ct scan will be performed for each patient pre-therapy and on the same machine as the 18f-fdg pet/ct scan and within 14 days before the start of treatment.

Eligibility criteria:
inclusion criteria: 1. female with age ≥ 18 years, 2. patients with previously untreated, non-metastatic, centrally confirmed tnbc (stage t1c n1-2 or t2-4 n0-2 per ajcc) for whom a neoadjuvant treatment with chemotherapy + pembrolizumab is the recommended option as standard of care, 3. patients with measurable targets according to recist/percist criteria, 4. patients without distant metastasis based on staging 18f-fdg pet/ct, 5. patients with tumor tissue available, 6. patients who provided a signed written informed consent, 7. patient ability to comply with protocol requirements, 8. patients covered by a health insurance system. exclusion criteria: 1. pregnant and lactating women, 2. patients with prior anti-pd(l)1 immunotherapy, 3. patients with any contra-indication to chemo-immunotherapy standard of care therapy, per investigator assessment, 4. patients with altered mental status or psychiatric disorder that, in the opinion of the investigator, would preclude a valid patient informed consent, 5. patients who have difficulty undergoing trial procedures for geographic, social or psychological reasons, 6. patients who are not affiliated to a social security system, or who are deprived of liberty, or under guardianship. 7. person deprived of liberty or under guardianship
mindfulness for pain and suicide

Conditions: Chronic Pain; Suicidal Ideation; Suicide, Attempted; Opioid Use

Summary: the proposed study will assess the feasibility and acceptability of a mindfulness-based intervention to reduce functional impairment from chronic pain and risk of suicide.

the investigators are seeking to develop a combined intervention, mbct-s/p, to focus on both improving functioning and mitigating suicide risk in veterans with chronic pain. the investigators plan to test the new manual's feasibility and acceptability in a sample of veterans experiencing chronic pain and suicidal ideation. participants will be randomized to either the mbct-s/p condition (n=38) or the education control condition (n=38) to assess additional aspects of study feasibility. the investigators also plan to assess a variety of clinical outcomes including suicidal ideation, pain interference in activities, and opioid use. participants will complete questionnaires pre-treatment, and 1-, 3-, and 6-months post-treatment.

Eligibility criteria:
inclusion criteria: * english-speaking veterans * ages 18 years and older * understand informed consent * report pain that occurs on at least half the days for six months or more * score at least a 4 on each item of the three items on a brief pain intensity and interference measure * to meet the minimum threshold for suicide risk, veterans must meet at least one of the following: (1) endorse at least a 1 ("several days") on item 9 ("thoughts of you would be better off dead, or thoughts of hurting yourself in some way" in the past 2 weeks) of the patient health questionnaire-9 (phq-9), (2) endorse at least "death ideation" in the last 3 months as measured by the columbia suicide severity rating scale, or (3) report a suicide attempt in the last 6 months. exclusion criteria: * an active severe substance use disorder (sud) * documented schizophrenia, active psychosis, or mania * upcoming surgeries * uncontrolled medical conditions * intent to carry out a plan for suicide.
network supported engagement in hiv care

Conditions: HIV; Patient Acceptance of Health Care

Summary: the network supported engagement in care (nsec) intervention is a brief, theory based and culturally sensitive intervention designed to capitalize on organic yet underutilized social support networks in the lives of young black men who have sex with men (ybmsm) who have been recently diagnosed with hiv. the intervention has been developed with input from clients and their support network members, case managers, social workers, hiv primary care providers and pastoral care at a federally qualified health center. the goal of the intervention is to improve retention in care for newly diagnosed ybmsm who present for their first hiv primary care clinic appointment.


Eligibility criteria:
inclusion criteria: index subjects * self-identify as african-american and male; * same gender anal/oral sex in the past 2 years; * english speaking; * have at least one sc in their network; * own a cell phone not shared with other persons; * agreeable to text-message mini-booster sessions; and * between the ages of 16-29 years old. supportive contact: * index participant has agreed to including the supportive contact; * supportive contact is willing to attend face to face and telephone mini-booster sessions; * 18 years of age or older; * english speaking; and * owns a cell phone that is not shared with other persons. exclusion criteria: index subject: * unable to provide assent/consent; * plan to move out of the area within the next 12 months; * are not willing to attend intervention sessions; or * not willing to return for assessments supportive contact: * unable to provide informed consent; or * not willing to return for 3 and 12 month assessments.

Keywords: patient care management primary health care hiv patient acceptance of health care
a pilot study of a novel treatment regimen, maraviroc + ritonavir boosted atazanavir, in treatment naive hiv-infected patients

Conditions: Human Immunodeficiency Virus-1

Summary: this is a pilot study to examine if the novel treatment regimen maraviroc plus boosted atazanavir can be expected to be safe and efficacious in treatment naive hiv infected patients. based on the results from this study, a confirmatory phase 3 study may be conducted.


Eligibility criteria:
inclusion criteria: * hiv-1 rna viral load of ≥1,000 copies/ml measured at the screening visit. * cd4 count ≥100 cells/mm3 at screening. * have only r5 hiv-1 at screening as verified by the monogram bioscience trofile® assay with enhanced sensitivity. exclusion criteria: * prior treatment with any other hiv antiretroviral therapy for more than 14 days at any time. * any evidence of resistance to atazanavir, tenofovir, and emtricitabine. * x4-or dual/mixed-tropic virus by enhanced trofile assay or repeated assay failure or not reportable results.

Keywords: ccr5-tropic hiv-1 virus
safety and effectiveness study of everflex stent to treat symptomatic femoral-popliteal atherosclerosis

Conditions: Peripheral Vascular Diseases; Claudication

Summary: this is a multi-center, non-randomized, single arm study to compare pta and primary stenting using a single protégé® everflex™ stent to performance goals of pta alone in the treatment of atherosclerotic superficial femoral artery (sfa) and proximal popliteal lesions.


Eligibility criteria:
inclusion criteria: * stenotic, restenotic (from pta or adjunct therapy, not including stents or stent grafts) or occluded lesion(s) located in the native superficial femoral artery or superficial femoral and proximal popliteal arteries. * symptomatic femoral-popliteal atherosclerosis. * willing to comply with all follow-up evaluations at the specified times. * provides written informed consent prior to enrollment in the study. exclusion criteria: * previously implanted stent(s) or stent graft(s) in the target vessel. * planned use of devices other than angioplasty balloons during procedure. * received endovascular treatment of the target lesion (except stents/stent grafts) within six months of the index procedure. * life expectancy of less than 12 months. * symptomatic femoral disease in the opposite limb.

Keywords: sfa popliteal stent everflex