Kornimate/medical-research-clean huggingface dataset:
tolerance assessment of tailored 3d-printed tfo with silicone interface for the treatment of post-burn face scar

Conditions: Burn Scar

Summary: the purpose of this study is to assess the tolerance of tailored 3d-printed transparent face orthosis used in the medical care of post-burn face scar.

burn injuries are not a rare affection. according to who (world health organization), in 2004 there were 11 million peoples in the world who were affected by burn injuries caused by fire and who needed medical cares. this important number ignores non-fire thermal, chemical and electrical burns. face is one of the most susceptible areas of burn where the prevalence was reported to be 6-60%. hypertrophic scars (hs) are frequent consequences of dermal burn with a prevalence of 70% of burned people. hs, which are a dermal fibro-proliferation, are rigid, erythematous and thickened scars associated with pigmentation abnormalities, xerosis, thermal sensitivity, pain and pruritus. when hs is located on the face, they can cause cosmetic disorder with disfigurement and psychological distress. pressure therapy and silicone application are the two recommended non-invasive care for prevention and treatment of hypertrophic scarring after burn. on the face, pressure garment therapy (pgt) cannot exert the required pressure because of concave or flat shape so the use of face mask is the most common form of pressure therapy on the face. the face mask manufacturing is artisanal, time consuming and variable between all burn centers. they are not very accurate and have difficulties to apply effective pressure on certain face areas such as nasolabial folds. our transparent face orthosis (tfo) uses tri-dimensional cam for measurement and 3d-printing technology for manufacturing. we think this way to manufacture the tfo will be more accurate and efficient, less expansive and time consuming. moreover, the addition of a silicone interface between the tfo and the face will associate silicone application therapy and pressure therapy what should be more effective than pressure therapy alone. the purpose of this study is to assess the tolerance of tailored 3d-printed transparent face orthosis used in the medical care of post-burn face scar.

Eligibility criteria:
inclusion criteria: * age ≥18 years * post-burn face scar during maturation stage or surgical intervention on post-burn face scar during maturation stage * patient agrees to shave beard if necessary for 3d camera measurement * patient able to express informed consent * affiliation to a social security scheme exclusion criteria: * post burn face scar in the sequela stage * patient with unbalanced photosensitive epilepsy * patient with an unconsolidated fracture of the face's bones or skull * patient with a known allergy to silicone * pregnant or lactating women

Keywords: burns transparent face orthosis silicone application 3d printed face
optimization of patients long-term management after the coronavirus infection covid-19

Conditions: Covid19

Summary: 200 participants should be included in the study. there will be three groups: 100 participants with a severe course of the disease 3 months ago, 50 asymptomatic carriers of coronavirus infection 3 months ago and 50 people who were in close contact with patients with confirmed coronavirus infection 3 months ago, but not sick and without antibodies to sars-cov-2. the study consists of two visits. at the first visit, after signing the consent to participate in the study, a screening examination will be performed to assess the criteria for inclusion and exclusion in the study. at the second visit, patients who meet the inclusion criteria and do not have exclusion criteria will undergo clinical and instrumental examination, and biological samples will be collected for laboratory testing. the aim of the study is to determine the most significant clinical and laboratory markers of the severity of the outcomes in the period of convalescence of the new coronavirus infection covid-19. clinical and laboratory indicators, the number and severity of signs of postcovid syndrome as well as pathological changes in lung tissue according to ct data in the group with covid pneumonia and indicators of immune status, hemostasis, endothelial dysfunction, inflammation, metabolism will be assessed.


Eligibility criteria:
inclusion criteria: for all groups: * informed consent signed by the patient. * men and women aged 18 and over. group covid-19 (asymptomatic): * confirmed diagnosis of covid-19 (positive sars-cov-2 rna pcr test or history of igm and / or igg antibodies to sars-cov-2) * absence of any clinical symptoms associated with coronavirus infection. group healthy: * contact with patients with symptomatic new coronavirus infection covid-19 in the absence of personal protective equipment for at least 3 days. * absence of any clinical symptoms associated with coronavirus infection group covid symptomatic: * confirmed diagnosis of previous covid-19 (positive sars-cov-2 rna pcr test or presence of igm antibodies to sars-cov-2) in history. * a severe course of covid-19, characterized by one or more of the following symptoms: * respiratory rate ≥ 30 in 1 min * blood oxygen saturation (spo2) ≤ 93% * the ratio of the partial tension of oxygen in arterial blood to the fraction of oxygen during inspiration (pao2 / fio2) \<300 * lung tissue lesion\> 50% and / or according to computed tomography ct-2 and higher * septic shock / sepsis * development of multiple organ failure * cytokine storm exclusion criteria: * pregnancy * covid-19 vaccination * any serious medical illness before coronavirus infection, as well as a permanent form of atrial fibrillation * regular intake of anti-inflammatory, antibacterial, cytostatic and immunosuppressive drugs * refusal to participate in the study
ganaxolone in posttraumatic stress disorder (ptsd)

Conditions: PTSD

Summary: this phase 2 proof-of-concept study is a double-blind, randomized, placebo-controlled, 15-week investigation of ganaxolone versus placebo for the treatment of posttraumatic stress disorder (ptsd). up to 120 participants will be enrolled and randomized to receive either ganaxolone or placebo for 6 weeks. after 6 weeks of randomized treatment all participants will continue for 6 weeks on ganaxolone. the aim of the study is to assess the efficacy of ganaxolone compared to placebo for the treatment of ptsd symptoms after 6 weeks of treatment using the clinician-administered ptsd rating scale (caps). the second aim of the study is to evaluate the safety and tolerability of ganaxolone in the ptsd population.


Eligibility criteria:
key inclusion criteria: * veteran or civilian adult outpatients 18-55 years of age, with primary ptsd as defined by diagnostic and statistical manual of mental disorders-iv (dsm-iv) for at least 6 months * must be in general good health-confirmed by medical history, physical examination, and screening laboratory results * negative urine drug screen for drugs of abuse * negative urine pregnancy test for females of childbearing potential * sexually active participants are required to use a medically acceptable form of birth control key exclusion criteria * clinically unstable medical disease; progressive cns disorder/disease; history of seizures (except childhood febrile seizure); moderate or severe traumatic brain injury (tbi) * females who are pregnant or currently breast feeding * current or past psychotic disorder, bipolar type i disorder, or dementia * participants with recent drug abuse or dependency (excluding nicotine and caffeine) * participants unwilling to comply with the required alcohol prohibition during the trial * current suicidal or homicidal ideation necessitating intervention, and those with a history of suicide attempt in the past 10 years * participants with pending litigation related to the traumatic event * participants who are unwilling to withhold grapefruit or grapefruit juice for the duration of the study * participants receiving psychotherapy without a stable paradigm for at least 3 months * non-english speaking participants.

Keywords: ptsd posttraumatic stress disorder pharmacotherapy ganaxolone
intraoperative peak airway pressure changes on postoperative pulmonary function after muscle plication

Conditions: Abdominal Compartment Syndrome

Summary: an abdominal panniculus excision procedure is known as an abdominoplasty (panniculectomy). musculofascial plication is a crucial aspect of abdominoplasty, especially for patients with significant divarication of the recti muscles. this study aimed to evaluate the effect of intraoperative changes in peak airway pressure (pap) after muscle plication on postoperative pulmonary function.

musculofascial plication is a crucial aspect of abdominoplasty, especially for patients with significant divarication of the recti muscles. this surgical procedure involves the removal of surplus skin and fat around the abdomen, known as panneculectomy, and the anterior abdominal wall muscles' laxity being tightened. this study aimed to elucidate the effect of intraoperative changes in pap after muscle plication on postoperative pulmonary function.

Eligibility criteria:
inclusion criteria: * age ranged between 20 and 50 years old, * american society of anesthesiologists (asa) physical status classification i * came for abdominoplasty operation exclusion criteria: * anemia or hemoglobin levels below 11g/dl * bleeding problems * cardiovascular disorders * restrictive and obstructive respiratory disease * abdominoplasty without plication.
establishment and application of dementia case management information system: a preliminary study

Conditions: Dementia

Summary: the purpose of this study is to develop and examine the preliminary effects of an information system for facilitating dementia case management in the home setting. this study is the second phase of the project. the first year is the development stage of the information system. in the second year, the investigators will conduct a pilot study to examine the effectiveness of the case management information system.

the purpose of this study is to develop and examine the preliminary effects of an information system for facilitating dementia case management in the home setting. in the previous research (phase i), a mixed method was used to explore the content of case management and assess the needs of the information system. this study is the second phase of the project. the first year is the development stage of the information system. based on the data collected in the previous research (phase i), the content and method of dementia case management will be established by the delphi method, and then the dementia case management information system will be constructed accordingly. in the second year, the investigators will conduct a pilot study to examine the effectiveness of the case management information system.

Eligibility criteria:
inclusion criteria: * dementia case managers: 1. be at least 20 years old and could communicate in chinese or taiwanese. 2. currently work for dementia center, dementia care center, or community-based dementia care center in taiwan. * dementia family caregivers: 1. be at least 20 years old and could communicate in chinese or taiwanese. 2. primary caregivers 3. the people with dementia under care are diagnosed with dementia clinical dementia rating(cdr) 0.5 or higher. 4. live in northern taiwan(including taipei, new taipei, taoyuan, and hsinchu). exclusion criteria: * dementia case managers: no longer working for dementia center, dementia care center, or community-based dementia care center in taiwan. * dementia family caregivers: the people with dementia under care live in a long-term care facility or nursing home.

Keywords: dementia case management information system
nasal high frequency oscillation for respiratory distress syndrome in twins infants

Conditions: Nasal High Frequency Oscillation Ventilation

Summary: the investigators compared advantages and disadvantages of two forms of noninvasive respiratory support -noninvasive high-frequency oscillatory ventilation (nhfov) or nasal continuous positive airway pressure (ncpap) -as a primary mode of ventilation in preterm twins infants with respiratory distress syndrome

invasive ventilation is related to development of adverse pulmonary and nonpulmonary outcomes in ventilated infants. various modes of noninvasive respiratory support are being increasingly used to minimize the incidence of bronchopulmonary dysplasia (bpd). the aim of this trial to compare the effects of noninvasive high frequency oscillatory ventilation (nhfov) and nasal continuous positive airway pressure (ncpap) in preterm twins infants as the primary mode.

Eligibility criteria:
inclusion criteria: 1. gestational age (ga) is from 26 to 37 weeks; 2. diagnosis of respiratory distress syndrome. the diagnosis of respiratory distress syndrome will be based on clinical manifestations (tachypnea, nasal flaring and or grunting) and chest x-ray findings; 3. respiratory distress syndrome silverman score \>5; 4. informed parental consent has been obtained. exclusion criteria: 1. severe respiratory distress syndrome requiring early intubation according to the american academy of pediatrics guidelines for neonatal resuscitation7; 2. major congenital malformations or complex congenital heart disease; 3. group b hemolytic streptococcus pneumonia, septicemia, pneumothorax, pulmonary hemorrhage; 4. cardiopulmonary arrest needing prolonged resuscitation; 5. transferred out of the neonatal intensive care unit without treatment.
icg-based fluorescence imaging for intra-operative detection of endometriosis

Conditions: Endometriosis

Summary: endometriosis is a common disease for which the current gold standard for diagnosis is a diagnostic laparoscopy with histologic confirmation. however, during the diagnostic laparoscopy endometriotic lesions are hard to identify due to the many appearances of endometriosis. our hypothesis is that the use of intra-operative near infrared fluorescence imaging will provide real time image enhancement for the detection of endometriotic lesions by using the different vasculature in the endometriotic lesions. this hypothesis will be tested in a prospective study with 15 patients scheduled for an elective diagnostic laparoscopy for suspected endometriosis.


Eligibility criteria:
inclusion criteria: * patients scheduled for elective laparoscopic surgery in which endometriosis is suspected * able to understand the nature of the study and what will be required of them * females * age \>18years * premenopausal * no history of impaired liver and renal function * no history of hypersensitivity or allergy to indocyanine green or iodide * no hyper-thyroidism or autonomic thyroid adenomas * willing to participate exclusion criteria: * not able to give written informed consent * males * aged \< 18 years * pregnant or breast-feeding women * known hypersensitivity or allergy to indocyanine green or iodide * known hyper-thyroidism or autonomic thyroid adenomas * not willing to participate

Keywords: near infrared fluorescence imaging indocyanine green (icg)
marine n-3 polyunsaturated fatty acids in pre- and postmenopausal women

Conditions: Postmenopause; Premenopause

Summary: the study is a randomised placebo controlled double-blinded clinical trial where a group of healthy pre- and postmenopausal women is randomised to the intake of fish oil capsules or placebo oil capsules for 12 weeks. anthropometric measurements(weight, height,blood pressure) blood samples and adipose tissue biopsies will be taken in order to illustrate the effect of marine n-3 pufas (fish oil) on the concentration of circulating female hormones and to investigate what impact menopause might have on the ability to incorporate marine n-3 pufas into tissues.


Eligibility criteria:
inclusion criteria: * age 18-70 years old * healthy or well-treated chronic disease exclusion criteria: * hormone treatment * foreseen compliance problem * fish oil consumers

Keywords: n-3 pufas menopause adipose tissue estrogens incorporation of fishoil in pre- and postmenopausal women marine n-3 pufas influence on female hormones in blood
effects of tens and ies on the autonomous balance of normotens volunteers and hypertensive patients

Conditions: Healthy Volunteers; Hypertension, Essential

Summary: hypertension is considered a serious public health problem. the imbalance in autonomic nervous system (ans) activity is one of the main triggers in the development and maintenance of hypertension. the non-pharmacological management of this disease is an important resource, especially in refractory hypertensive patients or in hypertensive crises, where the pharmacological treatment does not present an efficient response. it is known that transcutaneous electrical nerve stimulation (tens) is capable of modifying the autonomic balance, however, the effects of interferential electrical stimulation (ies) on this system in normotensive and hypertensive volunteers are not yet known. these electrotherapeutic resources may be a non-pharmacological tool supporting the management of hypertension. the objective of this research is to study the effects of different tens and ic parameters on cardiovascular variables of normotensive volunteers and hypertensive patients.

each volunteer will perform three assessments with a one-week interval. each assessment will include assessment of autonomic balance, blood pressure, and blood collection (catecholamines). interventions (placebo, low frequency tens and ies) will be randomized. volunteers will be accommodated in the supine position. with properly sanitized skin (70% alcohol) and self-adhesive electrodes (5x5 area) will be positioned in the cervical paravertebral region. all participants will be submitted to a placebo tens session, a low frequency tens session (tens, 10 hz/200μs) and an ies session (stein et al., 2012). the sessions will take place in the morning in a 12-hour fast, lasting 30 minutes, in an air-conditioned place (23ºc).

Eligibility criteria:
inclusion criteria: * both sexes; * normal blood pressure (pas \ 140 mm hg and/or diastolic blood pressure (dbp) \>90 mm hg and clinical stability with no change in medications for at least 2 months preceding the study; * the subjects that joined the study will be alphabetized volunteers; * age between 20 and 65 years old; * with no symptoms of skeletal muscle disorders; * no previous performing cardiovascular surgery; * no previous diagnose of rheumatic, neurological, oncological, immune or hematologic diseases; * without evidence of psychiatric diseases and/or cognitive déficit; * non-smoker; * volunteers with a body mass index (bmi: kg/m2) greater than 35 will not be included in the study exclusion criteria: * on the day of the assessments who have consumed of the alcoholic drink, caffeine and citrus juice and who have performed intense physical activities 48 before the examination
a study to assess intrahepatic and peripheral changes of immunologic and virologic markers in chronic hepatitis b virus infection

Conditions: Hepatitis B

Summary: the purpose of this study is to assess changes in intrahepatic hepatitis b surface antigen (hbsag) between baseline and on-treatment liver biopsy in response to jnj-3989-based combination treatment.

the title of protocol reflects the original study design. the study design section is reflecting that the design as of protocol amendment 5 is non-randomized.

Eligibility criteria:
inclusion criteria: * medically stable on the basis of physical examination, medical history, vital signs, and triplicate 12-lead electrocardiogram (ecg) performed at screening * hepatitis b virus (hbv) infection with documentation at least 6 months prior to screening: participants be either currently not treated with hbeag positive status or virologically (nucleos\[t\]ide analog \[na\]) suppressed with hbeag negative status * hepatitis b surface antigen (hbsag) greater than (\>) 100 international units per milliliter (iu/ml) at screening * body mass index (bmi) between 18.0 and 35.0 kilogram per meter square (kg/m\^2), extremes included * highly effective contraceptive measures in place for female participants of childbearing potential or male participants with female partners of childbearing potential * fibroscan liver stiffness measurement less than and equal to (\<=) 9 kilopascal (kpa) within 6 months prior to screening or at the time of screening exclusion criteria: * evidence of infection with hepatitis a, c, d or e virus infection or evidence of human immunodeficiency, virus type 1 (hiv-1) or hiv-2 infection at screening * history or evidence of clinical signs/symptoms of hepatic decompensation including but not limited to: portal hypertension, ascites, hepatic encephalopathy, esophageal varices * history or signs of cirrhosis or portal hypertension, signs of hepatocellular carcinoma (hcc) or clinically relevant renal abnormalities on an abdominal ultrasound performed within 6 months prior to screening or at the time of screening * presence of coagulopathy or bleeding disorder as indicated by: (a) international normalized ratio (inr) greater than or equal to (\>=) 1.1\* upper limit of normal (uln); (b) partial thromboplastin time \>1.1\*uln; (c) any signs of prolonged bleeding (\>10 minutes) * presence of hemoglobinopathy (including sickle cell disease, thalassemia) * liver biopsy performed prior to screening that led to complications and that in the opinion of the investigator would prohibit another liver biopsy
a multi-center, single-arm trial exploring the safety and clinical effectiveness of rbx2660 administered by colonoscopy to adults with recurrent clostridioides difficile infection

Conditions: Clostridium Difficile Infection Recurrence

Summary: this trial will be initiated to explore whether rbx2660 (rebyota®) could be suitable for administration by the practice of colonoscopy. more specifically, the purpose of this trial is to explore the safety and clinical effectiveness of rbx2660 when delivered by colonoscopy to adults with rcdi. the experience of physicians will be documented through a physician-experience questionnaire to explore the usability of rbx2660 in clinical practice for colonoscopic administration. furthermore, to explore the patient-experience of rbx2660 treatment, each trial participant will be offered to undergo a structured interview.


Eligibility criteria:
inclusion criteria: * have documented evidence of rcdi (≥1 recurrence after a primary cdi episode) * be undergoing antibiotic treatment for the qualifying rcdi episode that was diagnosed by a stool test for the presence of toxigenic c. difficile or c. difficile toxin * be eligible for fmt as judged by the investigator or current treatment guidelines for rcdi in the us * be a candidate for colonoscopy as judged by the investigator exclusion criteria: * use or planned use of systemic antibiotics for an indication other than the qualifying rcdi episode. * current uncontrolled chronic diarrhea not related to cdi. * receipt of cdi vaccine or treatment with cdi monoclonal antibodies within the past 12 months before screening. * evidence of active, severe, or fulminant colitis, diagnosis of toxic megacolon or have a current colostomy or ileostomy

Keywords: c. difficile diarrhea clostridium difficile cdi fmt fecal microbiota transplant microbiota restoration therapy diarrhea microbial suspension fecal transplant c difficile colitis clostridium difficile associated diarrhea c diff diarrhea c difficile c diff