Kornimate/medical-research-clean huggingface dataset:
harmonics-based in vivo optical virtual biopsy

Conditions: Healthy Participants With Different Skin Types and Different Ages; Diseased Participants With Different Skin Types and Different Ages; Participants Suffered From Diabetes With Different Skin Types and Different Ages

Summary: the research aims to study the molecules and structures in human skin by the image formation of harmonic-based in vivo optical virtual biopsy.

in the research, the investigators use the cr:forsterite laser as the light source, and utilize the nonlinear optical microscopic system to observe human skin via in vivo detection. in this study, images of human skin tissue will be acquired by virtual section to truly evaluate the feasibility of this system in clinical application. this research intends to conduct the following research: 1. to study the feasibility of this technology to observe melanin in the skin: as melanin is thg-bright, the technology will help to explore the distribution and change of melanin in the skin. 2. to study the capability of this technology in the early diagnosis of skin cancers, including melanoma, basal cell carcinoma, and squamous cell carcinoma: by obtaining skin images of healthy and diseased patients, we can establish an image database of normal and cancerous skin in different atages, and evaluate the efficacy of this technology for early diagnosis of skin malignancy in the future. 3. to study the ability of this technology to observe and analyze the degree of skin aging: optical sectioning of human skin in a non-invasive in vivo manner can be used to detect the microscopic changes of skin aging and solar damage, and to find out the indicators of skin aging, so as to be used in the future to assist the therapeutic analysis of anti-skin aging treatment. 4. to study the ability of this technology to observe peripheral vasculopathy and molecular changes of microvascular structures in diabetic patients: perform microscopic imaging on healthy and diabetes patients' skin to observe effects of structures and molecules in their skin, such as peripheral vasculopathy in diabetic patients, and the status of disease parameters, with a view to find the cause of peripheral vascular lesions and other biological information.

Eligibility criteria:
inclusion criteria: 1. healthy volunteers of different skin colors and different ages 2. patients with suspected melanoma 3. patients with suspected basal cell carcinoma or squamous cell carcinoma 4. patients with diabetes mellitus exclusion criteria: 1. volunteers have infectious disease 2. volunteers' skin have been infected with ulceration

Keywords: healthy human skin skin cancer melanoma basal cell carcinoma squamous cell carcinoma diabetes mellitus
brain plasticity and cellular aging after internet-delivered cbt for social anxiety disorder

Conditions: Anxiety Disorders; Social Anxiety Disorder

Summary: this study evaluates underlying psychological and biological mediators in internet-delivered cognitive behavior therapy for adults with social anxiety disorder.

internet-delivered cognitive behavior therapy for social anxiety disorder has previously demonstrated to target and affect the brain´s fear network, typically neural response in the amygdala ameliorate after effective psychological treatment. commonly, neuroimaging studies have performed brain imaging at pre- and post-intervention, yet, longitudinal study designs including several repeated measures of neural response over the course of treatment are currently missing in anxiety disorder. in the current study the participants will undergo magnetic resonance imaging (mri) at four occasion. a) twice before treatment initiation (9 weeks apart), b) at week 4 (during treatment), c) and directly after treatment termination. biological aging can be quantified at the individual cell level by measuring telomere length in peripheral immune cells (leukocytes). telomeres are located at the end of each chromosome and protect the genetic material during cell division. telomerase is an enzyme that can lengthen telomeres, and have in this way a protective function against accelerated cellular aging. variations in these bodily processes have been associated with psychiatric manifestations such as anxiety and depression. in the current study the participant´s telomere length and telomerase activity will be assessed at three occasion. a) twice before treatment initiation (9 weeks apart), and b) directly after treatment termination.

Eligibility criteria:
inclusion criteria: * social anxiety disorder as primary diagnosis (dsm-5) * otherwise somatically healthy * willingness to participate in a symptom provocation brain imaging trial exclusion criteria: * concurrent psychological treatment * treatment of social anxiety within the three months preceding the study * chronic use of prescribed medication that could influence the results (anxiolytic or antidepressant drugs, certain hypnotics or herbs like st johns wort) * contraindications for mri investigation (implants or other metal objects in the body, brain and heart operations) * pregnancy or planned pregnancy during the first 6 months of the study period * postmenopausal women * any neurological disorders * depressive symptoms, as determined by scoring more than 20 on the madrs questionnaire (self-report version) * suicidal ideation (scoring more than 2) on the self-report version of madrs, item 9 * suicide at moderate risk (mini v7) * bipolar disorder (mini v7) * psychotic syndromes (mini v7) * substance abuse disorders (mini v7) * alcohol abuse (mini v7) * any eating disorder (mini v7) * antisocial personality disorder (mini v7)

Keywords: magnetic resonance imaging cognitive behavior therapy telomerase telomere length, mean leukocyte
safety, pk and anti-inflammatory effects of cc10 protein in premature infants with respiratory distress syndrome (rds)

Conditions: Respiratory Distress Syndrome in Premature Infant; Bronchopulmonary Dysplasia

Summary: bronchopulmonary dysplasia (bpd) is a multi-factorial disease process that is the end result of an immature, surfactant deficient lung that has been exposed to hyperoxia, mechanical ventilation and infection. these conditions initiate an inflammatory response characterized by elevated inflammatory cell infiltrates and proinflammatory cytokines that lead to the development of significant acute and chronic lung injury. the study drug, rhcc10, is a recombinant version of natural human cc10 protein. native cc10 is produced primarily by non-ciliated respiratory epithelial cells, called clara cells and is the most abundant protein in the mucosal fluids in normal healthy lungs. the purpose of this study was to evaluate the pharmacokinetics, safety, tolerability and anti-inflammatory effects of a single intratracheal (it) dose of rhcc10 to intubated premature infants receiving positive pressure ventilation for treatment of respiratory distress syndrome (rds) to prevent long term respiratory complications referred to as bronchopulmonary dysplasia, and, more recently, as chronic respiratory morbidity (crm; asthma, cough, wheezing, multiple respiratory infections). cc10 regulates inflammatory responses and protects the structural integrity of pulmonary tissue while preserving pulmonary mechanical function during various insults (eg. viral infection, bacterial endotoxin, ozone, allergens, hyperoxia). together these properties suggest that administration of rhcc10 may help to facilitate development of normal airway epithelia and prevent the inflammation that leads to crm in these infants.


Eligibility criteria:
inclusion criteria: newborn infants were considered for the study if the following criteria were met: * age \< 24 hours; * birthweight between 700 and 1,300 grams; * gestational age greater than or equal to 24 weeks; * diagnosis of neonatal rds based on clinical and radiographic criteria; * requiring intubation and mechanical ventilation for treatment of rds; * received at least one dose of surfactant 100 mg/kg (survanta; ross laboratories); * written informed consent from the infant's parent or legal guardian prior to enrollment of the patient and agrees to all study-related procedures and evaluations, including those required after hospital discharge. exclusion criteria: • major congenital abnormalities (chromosomal, genetic, cardiac, pulmonary, or renal);

Keywords: cc10 bpd bronchopulmonary dysplasia premature infants neonates pulmonary inflammation lung function rds
efficacy and safety study of udenafil to treat erectile dysfunction

Conditions: Erectile Dysfunction

Summary: study design : multi-center, double-blind, placebo-controlled, randomized, parallel group, fixed dose design phase : phase iii


Eligibility criteria:
inclusion criteria: * male patients aged 20 years or more diagnosed with ed exclusion criteria: * had uncontrolled blood pressure * had hepatic or renal dysfunction * was currently under anticancer chemotherapy * had a treatments for ed using other pde-5 inhibitors
genetic evolution of arboviruses in new caledonia between 1995 and 2024 and impact of wolbachia

Conditions: Arbovirus Infections; Dengue; Zika; Chikungunya

Summary: arboviruses, diseases transmitted to humans by the bite of an insect vector, are a major public health problem, especially in tropical and sub-tropical countries. a promising strategy aimed at blocking the circulation of arboviruses is to release aedes aegypti mosquitoes carrying the endosymbiotic bacterium wolbachia. in 2019, the wolbachia strategy was implemented in nouméa as part of the world mosquito program. this intervention will modify the epidemiological profile of arboviruses in new caledonia. epidemiological surveillance of arboviruses requires molecular characterization of the virus contained in the serum obtained from the blood collected from patients. this molecular characterization by rna isolation techniques, rt-qpcr monitoring and sequencing allows the construction of phylogenetic trees. in the context of the implementation of the world mosquito program in nouméa, the investigators plan to follow the molecular evolution of arboviruses, over the period preceding the releases of mosquitoes carrying wolbachia (from 1995 to 2019) then over a period of 5 years. following the releases. at the same time, the virus can be isolated by cell culture techniques and in vitro infections, allowing its study in vitro in cells or in vivo in mosquitoes. this study allows us to measure the impact of the wolbachia strategy on the evolution of the virus's ability to replicate in cells in the presence of wolbachia and to be transmitted by the mosquito.

collection of blood samples from patients with arbovirus infection this study is a non-interventional study with retrospective part. this study will improve : * the assessment of the molecular evolution of arboviruses in the period preceding the implementation of the wolbachia strategy * the knowledge of the impact of wolbachia on the diversity and molecular evolution of arboviruses * the understanding of arbovirus transmission and replication mechanisms in the presence of wolbachia

Eligibility criteria:
inclusion criteria: * appearance of clinical signs suggestive of an infection with an arbovirus in the 7 days preceding the blood sample, * diagnostic confirmation by rt-qpcr of mono-infection with dengue virus or another arbovirus. * patients or their representative (s) informed of the possible secondary use for research purposes of the samples initially taken for diagnostic purposes and their derivatives, and who have not since expressed their opposition to the secondary use of the samples diagnostics or their derivatives for research, exclusion criteria: * documented opposition from a patient or his representative (s) * previously established viral load too low. * sample obtained from a sample taken more than 7 days after the appearance of clinical signs of infection.

Keywords: new caledonia
energy homeostasis under treatment with atypical antipsychotics

Conditions: Schizophrenia

Summary: the purpose of this study is to evaluate the effects of different atypical antipsychotics on weight changes, energy homeostasis, metabolism, energy intake as well as activity. patients with schizophrenia or schizoaffective disorders will be randomly assigned to be treated with ziprasidone or olanzapine for 24 weeks. primary outcome parameter are the weight changes after 24 weeks.


Eligibility criteria:
inclusion criteria: * diagnosis of schizophrenia or related disorders(dsm-iv) * indication for long-term treatment with antipsychotics * bmi between 20 to 30 * weight changes less than 3kg in the last 3 months before inclusion * informed consent exclusion criteria: * psychiatric comorbidity * depot antipsychotic in the last 2 months * antipsychotics in the last 2 weeks * treatment with olanzapine, clozapine or ziprasidone in teh last 3 months * treatment with drugs, that may lead to weight changes * significant endocrine, neurological, cardiovascular, hepatic, renal, metabolic, or other medical diseases or any clinically relevant abnormalities in laboratory tests * female subjects during pregnancy and breastfeeding * female subjects within childbearing years who were not using adequate birth control * patients who are judged by the investigator to be at serious suicide risk

Keywords: weight gain schizophrenia atypical antipsychotics
painful procedures in the emergency department: a distraction intervention

Conditions: Pediatric Pain and Anxiety

Summary: this study is designed to assess the effectiveness of the video-based intervention over and above current standard practice for pain control in the pediatric emergency department (ed). this is a single-center trial based at the iwk health centre. the primary outcome will be based on the campis coding of the video-taped pain response of the research participants.

the purpose of this study is to determine if the pain and anxiety that children experience when they have venipuncture procedures performed can be reduced by a video-based distraction and coping strategy intervention. an instructional video has been designed to educate parents and children about what is going to happen during the venipuncture procedure; to teach coping skills that can be used before and during the painful procedure; and to provide distraction during the procedure by using an entertaining video segment. approximately 168 children (6-12 years of age)who are seen in the iwk ed requiring venipunctures for blood collection or iv starts will be randomized. parent and child training in distraction and coping strategies will be provided by means of a self-administered video-delivery via a portable dvd player. fifty percent of the eligible participants will receive the distraction and coping strategies intervention and 50% will receive the standard medical care provided by the iwk ed. those receiving standard care will be evaluated for outcome results and then be compared to the intervention group. it is expected that children who receive the intervention will report less pain and anxiety associated with venipunctures than those who receive standard care.

Eligibility criteria:
inclusion criteria: participants will be eligible for this study if they: * are between 6-12 years of age * are presenting in the iwk emergency department who require a venipuncture for blood collection or iv initiation. * are able to read and speak english * provide written parental authorization and verbal child assent exclusion criteria: participants will be excluded for this study if they: * are in critical condition as determined by ed staff * are in significant pain for other reasons other than the venipuncture * have severe cognitive delay * who require sedation for the venipuncture as determined by the ed staff

Keywords: pediatric pain pediatric anxiety painful procedures
perimenopause and menopause in women with spinal cord injury

Conditions: Menopause; Spinal Cord Injury

Summary: a lot of information is known about how the perimenopause and menopause affects able bodied women. however there is very little information about how these affects women with spinal cord injury. this questionnaire study aims to collect information from women with a spinal cord injury on their experiences of going through the perimenopause and/or the menopause.

there is widespread knowledge and information about the perimenopause and menopause, its symptoms and treatment; all of this is for people without spinal cord injury (women will be used to denote all people who can or have undergone the perimenopause and menopause). there is paucity of data about this condition in women with spinal cord injury. these women are living longer lives and should be supported to live a healthy life. some studies have suggested that women with spinal cord injury (wsci) may undergo the perimenopause and menopause earlier than those without, however others have concluded that the age at the perimenopause and menopause is no different. wsci may suffer less with vasomotor symptoms due to their ability to manage the symptoms of autonomic dysreflexia; however they may have more genito-urinary symptoms; also due to the need for self-catheterisation. hormone replacement therapy (hrt) has many benefits including reduction in risk of fractures by slowing down the development of osteoporosis, thereby reducing fracture risk and morbidity. reduced mobility also puts them at an increased risk of cardio-vascular disease. this study aims to gain information about these characteristics of the perimenopause and menopause in wsci; the age at which they become menopausal and the most bothersome symptoms for them, treatment options offered to them as well as details of their spinal cord injury.

Eligibility criteria:
inclusion criteria: * • patient is willing and able to give informed consent for participation in the study (or verbally confirm they wish to take part if someone completing on their behalf) * who has undergone or currently experiencing the perimenopause or menopause * aged 18 years old or older * clinically diagnosed with a spinal cord injury at least 3 months ago * is either a) currently going through the perimenopause and menopause or b) has been through the perimenopause and menopause. exclusion criteria: * • individuals who have yet to go through the perimenopause and/or menopause
bevacizumab versus docetaxel/erlotinib on tumor metrics in patients with previously untreated advanced non small cell lung cancer

Conditions: Non Small Cell Lung Cancer

Summary: to determine the more effective dosing sequence of intermittent erlotinib and docetaxel for treating patients with the diagnosis of advanced non-small-lung-cancer.

in 2008, the hellenic co-operative oncology group (hecog) initiated a randomized phase ii study to determine the comparative efficacy of intermittent docetaxel/erlotinib chemotherapy, with erlotinib given for twelve consecutive days either before (group a) or after (group b) docetaxel, in chemotherapy-naive patients with advanced non small cell lung cancer. docetaxel chemotherapy was considered one of the valid non-platinum containing therapeutic options at that time and today represents one of the approved second-line treatment options after failure of first-line platinum based chemotherapy. the trial was terminated early due to slow accrual after enrollment of 51 patients and was published in 2014, showing no clinically meaningful difference between the two treatment arms. based on the aforementioned trial population,a parallel radiological study was conducted, evaluating sequential tumor metrics on computed tomography performed at baseline and after each cycle of treatment in patients receiving either bevacizumab or docetaxel/erlotinib. given the differential mechanism of action of these agents, it was hypothesized that the different parameters of radiological tumor response evaluation, namely the maximum diameter, tumor volume and tumor density, would respond differently for each therapeutic category (a chemotherapeutic agent, a molecular agent and and an anti-angiogenic agent). for bevacizumab, in particular, it was hypothesized that its unique mechanism of action, inducing central tumor necrosis and subsequent shrinkage, would lead to completely different tumor metrics as compared to the other two agents. herein the final results of this analysis are presented, showing the comparison of the three agents in terms of tumor response metrics, as evaluated in ct scans performed at baseline and after each cycle of treatment

Eligibility criteria:
inclusion criteria: 1. male and female patients aged 18 to 75 years inclusive, with histologically confirmed metastatic non small cell lung cancer will be enrolled. 2. eastern cooperative oncology group (ecog) performance status of 0 - 1. 3. presence of measurable or evaluable disease (lesions that are present but do not fulfil the criteria for measurable disease). exclusion criteria: 1. patients who have undergone complete tumor resection after responding to platinum based chemotherapy.
an extension (rollover) study of vemurafenib in participants with braf v600 mutation-positive malignancies previously enrolled in an antecedent vemurafenib protocol

Conditions: Neoplasms

Summary: this open-label, multicenter, non-randomized study provided continued access to vemurafenib for eligible participants with braf v600 mutation-positive malignancy, who were previously enrolled and treated in an antecedent vemurafenib protocol and did not meet the protocol's criteria for disease progression, or were treated beyond progression and were still deriving clinical benefit (as assessed by investigator), and may have therefore potentially benefited from continued treatment with vemurafenib. participants received treatment with oral vemurafenib at 960 milligrams (mg) twice daily (bid), 720 mg bid, or 480 mg bid, depending on the last dose in the antecedent protocol. treatment continued until progression of disease or as long as the participant was deriving clinical benefit, as judged by the investigator (case-by-case decision with approval of the medical monitor), death, withdrawal of consent, unacceptable toxicity, loss to follow-up, or decision of the sponsor to terminate the study, whichever occurred first.


Eligibility criteria:
inclusion criteria: * braf v600 mutation-positive malignancy * prior eligibility for and on study treatment from an antecedent vemurafenib protocol * ability to begin treatment in the extension (rollover) protocol within 15 days following the last day of the study in the antecedent protocol * female participants of childbearing potential and male participants with partners of childbearing potential must agree to use 2 adequate methods of contraception as defined by protocol during the course of this study and for at least 6 months after completion of study treatment exclusion criteria: * adverse event requiring discontinuation of vemurafenib in the antecedent protocol * progressive disease during the antecedent protocol. if approval to treat beyond progression was already given in the antecedent protocol, the participant may roll over into the current protocol without sponsor approval. under special circumstances, enrollment into this protocol and dosing beyond progression may be considered and will require approval of the sponsor participants meeting any of the following exclusion criterion of the antecedent study at the time the participant is considered for the extension (rollover) study: * current, recent (within 28 days prior to day 1), or planned use of any antitumor therapy outside this study * any other serious concomitant medical condition that, in the opinion of the investigator, would compromise the safety of the participant or compromise the participant's ability to participate in the study * history of malabsorption or other clinically significant metabolic dysfunction * history of clinically significant cardiac or pulmonary dysfunction as specified in antecedent study