Kornimate/medical-research-clean huggingface dataset:
bioequivalence study of escitalopram tablets 10 mg

Conditions: Anxiety Disorders

Summary: the objective of this study was to confirm if two formulations of escitalopram tablets are bioequivalent. test product was escitalopram (10 mg; glaxosmithkline) and reference product lexapro® (10 mg escitalopram; lundbeck). the single dosage was one tablet. the study was prospective, open-label, randomized, crossover, single dose, with 02 treatments, 02 sequences and 02 periods, under fasting conditions. the population was composed of 26 healthy volunteers, male adults between 18-50 years. the comparative bioavailability of the two formulations was evaluated based in statistical comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations in blood.


Eligibility criteria:
inclusion criteria: free will participation according to mexican regulation, helsinki declaration, and good clinical practice. males between 18 and 50 years. body mass index between 18 and 27.5 in good health by complete medical history and laboratory tests. blood pressure 130-90/ 90-60 mm hg; heart rate 55-100 beat per minute, respiratory rate 14-20 movements per minute. laboratory tests +/- 10% of normal interval (blood cytology, blood chemistry 27 elements, hepatitis b and c antigens, hiv, urinalysis, anti-doping, pregnancy, electrocardiogram) exclusion criteria: alteration of vital signs not complying with inclusion criteria history of cardiovascular, kidney, hepatic, muscular, metabolic, gastrointestinal (including constipation), neurologic, endocrine, hematopoietic (any kind of anemia), asthma, mental or organic disease. those suffering from muscular trauma 21 days before the beginning of the study. requirement of any kind of medication during the course of the study, except study medication. history of dyspepsia, gastritis, esophagitis, duodenal or gastric ulcer. exposure to medications known as inducers or inhibitors of hepatic enzymes or administration of potentially toxic medication in the 30 days before the study beginning. administration of any medication in the 14 days or 5 half-lives (whatever longer) previous to the beginning of the study. hospitalization for any cause in the seven months before the beginning of the study. administration of investigational drugs in the 60 days before the study. allergy to any medication, substance, or food. alcohol ingestion or intake of beverages containing xanthines (coffee, tea, cocoa, chocolate, mate, cola drinks) or ingestion of charcoal grilled food or grapefruit or orange juice in the 72 hours before the hospitalization or tobacco smoking in the 72 hours before the beginning of the study. blood donation or loss =\> 450 ml in the 60 days before the beginning of the study. history of drug or alcohol abuse. special diet requirement, for instance vegetarian diet. inability to understand nature, aims, and possible consequences of the study. evidence of non-cooperative attitude during the study.
lung volume changes in stable preterm infants positioned in car seats

Conditions: Premature Birth; Electrical Impedance Tomography (EIT); Lung Volume; Car Seat Transition for At-risk Infants

Summary: premature infants (infants born \<37 weeks' gestational age) are discharged from the hospital and transported home in car seats designed for term babies. the safe transport of these premature infants is an important concern. sub-optimal positioning in car seats can lead to breathing problems in premature infants. with the help of electrical impedance tomography, the investigators want to assess the changes in lung volume during the transition from a supine to a semi-upright position in the car seat.

hypothesis the investigators hypothesise that there is a decrease in the end-expiratory lung volume (eelv) of preterm infants transferred from supine to car seat position. they expect that the curved, semi-upright built of a standard car seat negatively impacts lung aeration and ventilation of preterm infants, which may result in cardiorespiratory events. they also hypothesise that eelv will normalise following the repositioning of the infant back to the supine position. primary objective the primary objective of this study is to assess lung volume changes during the transition from a supine to a semi-upright position in a car seat in preterm infants. study procedures as soon as all inclusion criteria are met, the study intervention is initiated. for the baseline measurement, the child is placed in supine position on a flat surface. the eit belt is attached at nipple level around the infant's thorax during the last nursing care before the start of the intervention. continuous measurement is conducted for 30 minutes. subsequently, the child, with the eit belt securely in place, is repositioned from a supine to a semi-upright position in a car seat, where another 30-minute measurement is taken. a third measurement will be conducted after the infant is returned to the standard supine position in his/her cot. manipulations during the measurement periods will be kept to a minimum to avoid disruptions or artefacts in the data recordings. eit data will be obtained for a total of 90 minutes (plus a maximum of 10 minutes for repositioning). subgroup analyses will be performed for the primary outcome: * preterm infants ≥ 32 versus \< 32 weeks at birth * infants with a weight ≥ 2 kg versus \< 2 kg at the time of the study * car seat positioning: nursing staff versus parents

Eligibility criteria:
inclusion criteria: * gestational age up to 36 6/7 weeks at birth and/or birthweight \< 2.5 kg * preterm born infants fulfilling all criteria for discharge from the nicu * discharge home planned within 48 hours * written informed consent by one or both parents or legal guardians as documented by signature. exclusion criteria: * severe malformation adversely affecting lung aeration or malformations limiting life expectancy. * inability of the parents to understand the study procedures due to cognitive or linguistic reasons.

Keywords: electrical impedance tomography premature birth car seat
chemoresistance of trophoblastic tumors

Conditions: Trophoblastic Tumor

Summary: gestational trophoblastic tumors are characterized by their development from placental tissue and their high invasive and metastatic potential. these are rare tumors (1/50 000 pregnancies) affecting young women for whom conservative fertility treatments are preferred. the therapeutic strategy is based on a chemotherapy whose choice of protocol is based on a clinico-biological score, figo score, which includes tumor size, gonadotropic chorionic hormone level used as quantitative tumor marker, number and localization. metastases. a figo score ≤6 allows the use of monochemotherapy (methotrexate) with a 5-year survival of approximately 99.7%. scores of 7 to 12 and ≥13 require multidrug therapy (ema-co) and are associated with 5-year survival of 95.1% and 61.6%, respectively. the chemotherapies currently used for the treatment of trophoblastic tumors have been described between the 1950s (methotrexate) and the 1980s (ema-co) and have a well documented toxicity regarding the risk of secondary tumors, early menopause or even death by toxicity. . to date, apart from the figo score, there is no predictor of resistance to chemotherapy in gestational trophoblastic tumors. however, among patients with a figo score ≤6 and receiving methotrexate in the first line, 9 to 46% will have a resistance and require a second line of treatment. similarly, if the score is ≥7, 10 to 30% of patients receiving ema-co will require at least a second line of multidrug therapy. the hypothesis of predicttro study is that tissue samples of gestational choriocarcinoma present a transcriptomic profile associated with the risk of further resistance to single or multiagent chemotherapy. the objective of predicttro is to identify a transcriptomic signature able to predict resistance to single or multiagent chemotherapy.


Eligibility criteria:
inclusion criteria: * confirmed gestational trophoblastic tumor histology * hcg follow-up of at least 12 months after hcg normalization * registration in the french reference center for trophoblastic diseases exclusion criteria: * tissue specimen (block/biopsy) not available * degraded quality of tissue sample not compatible with transcriptome analysis (\>20% of necrosis)
improving diagnosis and prediction of outcome in patients with severe disorders of consciousness

Conditions: Traumatic Brain Injury; Intracranial Hemorrhages; Subarachnoid Hemorrhage; Meningitis; Encephalitis; Stroke

Summary: patients with acute severe brain injury are usually admitted to the intensive care unit. a substantial proportion of these patients will have disorders of consciousness (doc) after interruption of sedation. it is difficult to reliably predict neurological outcome in these patients. dependent on the extent of permanently damaged brain areas, doc in patients with acute severe brain injury may improve or persist, eventually evolving into a minimal conscious state (mcs) or unresponsive wakefulness syndrome (uws). these conditions are accompanied by long term severe disability. in current practice, the decision to withdraw life-sustaining support is made by interpreting the results of repeated bedside neurological examination and conventional ct-brain imaging. reliable identification of patients with a possible good outcome, in whom treatment should not be withdrawn, is difficult. in this prospective observational cohort study we aim to identify patients with a good neurological outcome.

in order to identify patients with a good neurological outcome a combination of diagnostic tests is used. clinical rating scales * simplified evaluation of consciousness scale (seconds) and the full outline of unresponsiveness (four) score * once a week blood biomarkers * neuron specific enolase, neurofilament light, glial fibrillary acidic protein * sampling timepoints: 24h, 72h, 7 days and 14 days after brain injury * serum (stg-5) and plasma (edta-6) tubes, aliquoted (4 x 0.5ml) and stored at -80°c eeg with reactivity testing * standard 21-electrode montage * stimuli protocol i: a set of 5 stimuli repeated 3 times 1. auditory: clapping in hands, 2. auditory: calling patients name loudly, 3. visual: passive eye opening, 4. tactile: nasal tickle, 5. noxious: sternal rub each stimuli is applied for a duration of 5 seconds and an interval between stimuli of 30 seconds * stimuli protocol ii: cognitive-motor dissociation test mri-scan * sequences considered essential for patient care i.e.t1, t2, flair, dwi/swi * preferably, performed between 4-6 weeks after hospital admission

Eligibility criteria:
inclusion criteria: all patients that are admitted to the icu with the following criteria will be eligible for inclusion: 1. severe brain injury (gcs ≤ 8) as a result of: 1. traumatic brain injury 2. ischemic cerebrovascular accident 3. intracranial hemorrhage 4. meningo-encephalitis 5. subarachnoid hemorrhage 2. age ≥ 18 years old 3. written informed consent from legal representatives exclusion criteria: a potential subject who meets any of the following criteria will be excluded from participation in this study: * absence of informed consent * moribund at icu admission * progressive neurodegenerative disease * pre-admission life expectancy ≤ 6 months based on comorbidity * gcs has been \> 8 prior to inclusion * impossible to include within 24 hours after brain injury
identifying and genotyping homozygous familial hypercholesterolemia (hofh) patients

Conditions: Homozygous Familial Hypercholesterolemia (HoFH)

Summary: this study is designed to help identify patients with hofh due to mutations in the ldlr as confirmed by genotyping.

this is a non-interventional study; no investigational product is administered in this study. information collected in this study may be used to identify potential participants for clinical gene therapy trials in hofh. the investigator will discuss the study with participants who have a clinical presentation consistent with hofh and where possible, the treating physician, in order to assess their interest to participate. after informed consent has been obtained, participants will be asked to provide a blood sample (up to 40 ml) for genotyping to confirm genetic diagnosis of hofh due to mutations in ldlr, a lipid panel and anti-aav8 nab titer. participants and, whenever possible, their treating physician will complete a medical history questionnaire and provide supporting documentation. the informed consent form (icf) and data collection methods may vary depending whether the informed consent is obtained remotely or at a participating study site. information collected will include the following: * patient demographics (age, sex, weight) * medical history * previous genotype results (if available) * results of most recent lipid panel(s) * use of lipid lowering therapies, including failure to respond * assessment of presence of liver disease, including history of hepatitis b and c, human immunodeficiency virus (hiv), cirrhosis, and alcohol use once this information is received by the investigator and sponsor, a preliminary assessment of confirmation of a diagnosis of hofh will be performed. participants and/or their treating physician will be informed of the results of the genetic testing. all participants will be provided an opportunity to speak with a genetic counselor upon receiving the results of the genetic testing. data collected in this study may be used to identify potential candidates for separate clinical trial(s) using gene therapy.

Eligibility criteria:
inclusion criteria: 1. males and females ≥ 18 years of age 2. clinical presentation consistent with hofh exclusion criteria: 1. history of cirrhosis based on documented histological evaluation or noninvasive imaging 2. documented diagnosis of liver diseases 3. history of immunodeficiency diseases, including a positive hiv test result 4. previous organ transplantation

Keywords: ldl receptors gene therapy metabolic diseases rare diseases genetic diseases atherosclerosis cardiovascular disease genotype
impact of applying a bandage skin hydrogel on the pains of the head and neck in patients with cancer of head and neck treated with radiotherapy

Conditions: Head and Neck Cancer

Summary: the investigators hope to get by reduced and delayed acute radiodermatitis following the application of dressings to skin hydrogel hydrosorb®, a reduction in head and neck pains and improved quality of life of patients with head and neck cancer treated with concomitant radiotherapy.


Eligibility criteria:
inclusion criteria: * patient aged 18 years old * carcinoma oral cavity, pharyngolaryngeal or without lymphadenopathy door * patient treated by one of the following diagrams * radiotherapy alone * postoperative radiotherapy + / - sensitized platinum (cisplatin or carboplatin) * ar chemoradiation 5-fu and platinum (the cetuximab is not allowed) * diagram organ preservation (induction chemotherapy and radiotherapy in responders) * untreated patients * patient should receive conventional radiotherapy or tomotherapy * adapted stomatological care * life expectancy \> 3 months * who score \< 2 * patient stable, not having the time of the examination of evidence of recurrent or progressive malignancy other * - for patients with an indication of chemotherapy combined with radiotherapy,biological assessments compatible with chemotherapy: * wbc \> 3000/mm3, polynuclear \> 2000/mm3,platelets \> 150,000/mm3, creatinine less than 2 times normal; bilirubin less than 2.5 times normal * patient fluent in french * affiliation to a system of social security * patient has given written consent exclusion criteria: * patient with a history of malignancy, outside a basal cell carcinoma or cervical cancer treated and cured * patient has at the time of examination signs of recurrence or other neoplasia scalable * patient with a history of prior chemotherapy or radiation therapy with the exception of the scheme of organ preservation (induction chemotherapy before radiation) * for patients with an indication of chemotherapy combined with radiotherapy, contraindication to treatment with specific platinum (cisplatin or carboplatin) with or without 5 fluorouracil * infectious diseases uncontrolled * patient is pregnant or lactating or absence of contraception during their reproductive * patient hypertensive unbalanced under antihypertensive treatment * uncontrolled cardiac disease * patients with renal or hepatic * known allergy to any component of ialuset ® * patient deprived of liberty under guardianship * any medical condition or psychological associate that could compromise the patient's ability to participate in the study * inability to undergo medical test for geographical, social or psychological

Keywords: head and neck cancer hydrotac® radiodermatitis algia radiotherapy
effect of akkermansia muciniphila akk11 on metabolic and gut health in overweight and obese subjects

Conditions: Overweight or Obesity

Summary: to assess the efficacy and safety of the use of probiotics as a food supplement compared to placebo in regulating body metabolism and gut microbiota in overweight or obese subjects.


Eligibility criteria:
inclusion criteria: 1. 18-45 years old; 2. bmi ≥ 24 kg/m2 or men with a body fat percentage of ≥ 25% and women with a body fat percentage of ≥ 30%； 3. normal liver function indexes; 4. willing to complete study-related questionnaires and diaries and complete all clinical visits. exclusion criteria: 1. those who have been diagnosed with high uric acid or gout are not recommended to participate in the test; 2. psychiatric or neurological diseases, celiac disease, lactose intolerance, allergies; 3. have the following diseases: irritable bowel syndrome, ulcerative colitis, fatty liver, liver cirrhosis, etc.; 4. recently treated with antibiotics (i.e., \< 3 months prior to the start of the study); 5. participants who smoked more than 10 cigarettes per day were excluded; 6. it is not recommended to participate in other special circumstances, such as those who are allergic to probiotic products; 7. pregnant and lactating women are not suitable for experiments.
budesonide multimatrix(mmx) versus prednisolone in management of mild to moderate ulcerative colitis

Conditions: Ulcerative Colitis Chronic

Summary: my study aims to directly compare the efficacy and safety of budesonide mmx versus prednisolone in the management of mild to moderate cases of ulcerative colitis.

it is a randomized clinical trial where patients with mild to moderate ulcerative colitis who failed to respond to conventional therapy with mesalazine will randomly be divided into two groups one of them will be given prednisone and the other will be given budesonide mmx. the efficacy of budesonide mmx and prednisolone will be measured by the rate of clinical, laboratory, endoscopic, and histological improvement 8 weeks after randomization. clinical assessment (the rate of bowel movements and rectal bleeding) and laboratory investigations ( complete blood count \[cbc\], c reactive protein\[crp\], and fecal calprotectin) will be done after 4 and 8 weeks from treatment initiation. endoscopic and histological assessments will be done at week 8.

Eligibility criteria:
inclusion criteria: * this study will include patients with confirmed mild to moderate ulcerative colitis according to the mayo score activity index with ages ranging between 18-60 years old. exclusion criteria: * patients \< 18 years old. * pregnant females. * patients with proven infection with any enteric pathogens (e.g., shigella species, clostridium species, salmonella species, ova, parasites, clostridium difficile toxins a or b, or hiv infection). * patients who received oral or rectal steroids in the last 4 weeks, immunosuppressive agents in the last 8 weeks, or anti-tumor necrosis factor agents in the last 3 months. * patients with severe colitis (mayo score \>11); patients with evidence or history of toxic megacolon. * severe anemia (hemoglobin \<10.5 g/dl), leucopenia, or granulocytopenia. * patients using any cytochrome p450 inducers or inhibitors (e.g., ketoconazole, phenytoin) or antibiotics. * patients with renal disease/insufficiency. * patients with type i diabetes. * patients with glaucoma. * patients with malignancies. * patients with decompensated liver cirrhosis (child-pugh score b and c). * patients with covid 19 infection.

Keywords: ulcerative colitis. budesonide prednisolone
passive fit of cad/cam screw-retained metal frameworks versus screwmented ones

Conditions: Edentulous; Jaw

Summary: cad/cam (computer aided design/ computer aided manufacturing) constructed screw retained implant supported frameworks give solutions for the problems arising from the lost wax technique by improving accuracy, adaptation and passive fit of the final restoration. however, concerns about the passive fit of a pre-implant insertion cad/cam constructed framework still exists due to the expected errors in imaging, registration, surgical guide construction, adaptation and hence transferring the planned position intra-orally.

9. pico format: population: mandibular free end saddle requiring 2 implants. intervention: digitally fabricated screw-mented retained metal frameworks constructed before implant placement control: digitally fabricated screw retained metal frameworks constructed after implant placement outcome: outcome measuring device measuring unit passive fit one screw test binary 13 screw resistance binary radiographic ( digital periapical radiography) binary iii. methods a) participants, interventions \& outcomes 9. study settings: i. the study will be conducted at department of oral implantology, faculty of oral and dental medicine, cairo university, egypt. ii. participants will be selected from the outpatient clinic of implantology department, faculty of oral and dental medicine, cairo university, egypt. 10. eligibility criteria: a-inclusion criteria: i- mandibular kenndy class i. ii- opposing completely dentulous, fully or partially restored dentition. iii- good oral hygiene. iv- the patient should have bone for implants, minimum bone height 10 mm and minimum bone diameter should be 6 mm. v- adequate inter arch space for restoration 15mm or more. vi- adult patients age ≥18 years b- exclusion criteria: i. any medical disorder that could complicate surgical phase or affect osteointegration. radiation chemotherapy. ii. smokers more than 10/daily. iii. uncooperative patients. iv. patients with para-functional habits v. patients with severe periodontal diseases. vi. patients with limited mouth opening. vii. presence of intraoral pathological lesions. viii. diabetic (hba1c \>7.5%).

Eligibility criteria:
.inclusion criteria: * mandibular kenndy class i. * opposing completely dentulous, fully or partially restored dentition. * good oral hygiene. * the patient should have bone for implants, minimum bone height 10 mm and minimum bone diameter should be 6 mm. * adequate inter arch space for restoration 15 mm or more. * adult patients age ≥18 years exclusion criteria: * - . any medical disorder that could complicate surgical phase or affect osteointegration. radiation chemotherapy. * ii. smokers more than 10/daily. * iii. uncooperative patients. * iv. patients with para-functional habits * v. patients with severe periodontal diseases. * vi. patients with limited mouth opening. * vii. presence of intraoral pathological lesions. * viii. diabetic (hba1c \>7.5%)

Keywords: passive fit screwmented cad/cam frameworks