Kornimate/medical-research-clean huggingface dataset:
impact of different doses and routes of exogenous progesterone administration on endometrial receptivity parameters

Conditions: Infertility, Female; ENDOMETRIAL RECEPTIVITY

Summary: after so many years conducting artificial endometrial preparation cycles for embryo transfer, there is no clear indication about which is the optimal dose of exogenous progesterone in this scenario to optimize the outcome. taking into account that the luteal phase can be controlled by measuring serum p levels (not done until now), the next step is to find out which is the best dose and route of administration of exogenous progesterone for luteal phase in artificial cycles. therefore, the aim of this experimental study is to compare the endometrial function and structure, as well as the serum p levels according to the use of different types of exogenous progesterone available on the market depending on their doses and route of administration (vaginal, subcutaneous or intramuscular). the endometrial receptivity status will be compared in the different artificial cycles with the one observed in a natural cycle, without exogenous progesterone (only the endogenous one) as a control group. endometrial receptivity will be analysed by means of endometrial function and structure, but not by pregnancy outcome as in this study an embryo cannot be replaced in the uterus because an endometrial biopsy needs to be done to do this type of research.


Eligibility criteria:
inclusion criteria all women with no history of infertility who agree to participate in the study: 1. age: 18-35 years old, both inclusive 2. regular menstrual cycles 3. in good health and not suffering from any mental or medical condition(s) that would preclude participation in the study. exclusion criteria subjects who meet one or more of the following will not be considered eligible to participate in the pilot study: 1. simultaneous participation in other clinical studies that, at the researcher's criteria, could interfere with the results of this study. 2. taking oral contraceptives in the three months prior to signing informed consent. 3. presence of uterine pathology (submucosal or intramural myomas \>4 cm deforming cavity, endometrial polyps or müllerian anomalies) or adnexal pathology (communicating hydrosalpinx). 4. background of thrombosis, breast cancer, systemic diseases. 5. those unable to comprehend the investigational nature of the proposed study.

Keywords: luteal phase artificial endometrial preparation cycle progesterone endometrial gene expression endometrial receptivity
use of a treated, devitalized and sterile umbilical cord amniotic membrane in the treatment of stt osteoarthritis

Conditions: Osteoarthritis Hand

Summary: the aim of this open, prospective, multicenter trial is to evaluate the use of a sterile, devitalized, processed umbilical cord amniotic membrane implant placed in joint interposition in the treatment of stt osteoarthritis.


Eligibility criteria:
inclusion criteria: * male or female; age between 18 and 75 years. * patient with symptomatic stt oa. * patient treated medically for functional signs for more than 3 months, without improvement, justifying a surgical intervention. * patient with a quickdash score \> 33 points (converted to 50%). * patient with wrist pain in front of the stt joint at rest = or \> 4/10 on vas. * patient who received the study information and provided consent. * member or beneficiary of a national health insurance plan. exclusion criteria: * pregnant or breastfeeding woman; woman without effective contraception. * patient with functional rhizarthrosis that has not been stabilized or treated medically or surgically. * patient with signs of neuropathy with functional disorders such as hyperesthesia. * patient with uncontrolled epilepsy or neuropathy that contraindicates locoregional anesthesia. * person confined by a judicial or administrative decision. * adult subjected to legal protection measures or unable to provide his/her consent.

Keywords: scaphotrapeziotrapezoid osteoarthritis (stt oa)
nir fluorescence imaging during neck dissection in head and neck cancer patients after iv injection of icg

Conditions: Head and Neck Cancer

Summary: the purpose of this study is to determine if nir fluorescent imaging is an effective approach to detect the margins of head and neck tumours or lymph nodes draining the tumour

primary objective: definition of the distribution of intravenously injected icg in the normal and pathological lymph nodes draining the dissected tumor in head and neck cancer patients or in nodes recurrences in head and neck cancer secondary objectives: * evaluation of the ability of nir fluorescence imaging to determine the tumoral volume, specifically the margins of the tumoral tissues (in the operating room and in the pathology department) * analysis of the correlation between icg fluorescence and tumoral invasion in the dissected lymph nodes

Eligibility criteria:
inclusion criteria: * all patients requiring neck dissection with or without resection of the primary (the decision and the type of neck dissection are preliminary decided during head and neck multidisciplinary oncologic consultation). * informed consent form signed. exclusion criteria: * age less than18 years old. * inability to give informed consent. * history of allergy or hypersensitivity against the investigational product (its active substance or ingredients), to iodine or to shellfish. * apparent hyperthyroidism, autonomous thyroid adenoma, unifocal, multifocal or disseminated autonomies of the thyroid gland. * documented coronary disease. * advanced renal impairment (creatinine \> 1,5mg/dl). * during the 2 weeks before the enrolment, concurrent medication which reduces or increases the extinction of icg (i.e. anticonvulsants, haloperidol and heparin). * pregnancy, breastfeeding

Keywords: lymph nodes
resuscitation of late-preterm infants by using room air or 100% oxygen

Conditions: Asphyxia

Summary: in this randomized control trial, the investigators hypothesize that late-preterm infants resuscitated with a "low oxygen delivery" strategy (initiation of resuscitation with room air) will result in a significant reduction in oxidant stress without any harmful clinical effects.

the delivery of high oxygen concentrations leads to the production of free radicals that can injure many organ systems. some studies have shown that resuscitation of term newborn infants with room air were safe and of great benefit. a static room air, however, may be inappropriate for resuscitation of preterm infants. the number of late-preterm infants has increased in recent years, which represent approximately 70% of all preterm infants. our study will evaluate the safety and efficacy of using room air during resuscitation of late-preterm infants and whether this will avoid oxidative stress derived damage and improve outcomes.

Eligibility criteria:
inclusion criteria: * inborn infant * gestation 34 weeks to 36 weeks 6 days exclusion criteria: • known chromosomal or congenital anomalies

Keywords: asphyxia resuscitation room air
efficacy, safety, tolerability and pharmacokinetics of concomitant administration of tramadol with duloxetine or pregabalin

Conditions: Diabetic Polyneuropathy; Postherpetic Neuralgia

Summary: tramadol is an opioid analgesic, which is widely used in the treatment of acute and neuropathic pain. treatment of neuropathic pain often requires a combination of pain medications due to the complex nature of neuropathic pain and frequent inadequate response to drug treatment. common drugs used concomitantly with tramadol are snri antidepressant duloxetine and anticonvulsants such as pregabalin. both tramadol and duloxetine have serotonergic effects and duloxetine has also a potential to inhibit metabolism of tramadol. the objective of the study is to investigate the pharmacokinetics and pharmacodynamic interaction of oral tramadol with duloxetine and pregabalin in patients with chronic neuropathic pain due to postherpetic neuralgia or diabetic polyneuropathy. all subjects will receive tramadol and duloxetine or tramadol and pregabalin in a randomized double-blind order. primary end point is o-desmethyltramadol concentration.


Eligibility criteria:
inclusion criteria: * chronic (≥ 6 months) neuropathic pain due to postherpetic neuralgia or diabetic polyneuropathy * pain intensity ≥ 4 on a numerical scale of 0-10 * informed consent exclusion criteria: * clinically significant abnormalities in laboratory screening * pregnancy * depression * use of strong opioids (morphine, oxycodone, fentanyl, hydromorphone, methadone) * a previous history of intolerance or allergy to the study drugs or to related compounds and additives * existing or history of seizures, haematological disorders, clinically significant renal, hepatic, respiratory, cardiac or psychiatric disease, dementia, drug allergy * previous or present alcoholism, drug abuse, psychological or other emotional problems or cognitive impairment that are likely to invalidate informed consent or limit the ability of the subject to comply with protocol requirements * concomitant drug therapy known to cause significant enzyme induction or inhibition of cyp 1a2, 2d6, 3a4, 2b6, drugs metabolised by cyp2d6 enzyme, antidepressants, mao-inhibitors, non-steroidal anti-inflammatory analgesics.

Keywords: pharmacokinetics pharmacodynamics interaction tramadol duloxetine pregabalin
pharyngeal size in patients with obstructive tonsils under orthodontic treatment

Conditions: Sleep Apnea Syndrome; Malocclusion

Summary: enlarged tonsils and malocclusion have relationship with sleep disturbance in children. the consequences of these features can include deviation of normal craniofacial growth such that this may result in a facial morphology more suitable to the development of sleep apnea later in life. the aim of this study was to compare the growth redirection, the evolution of respiratory symptoms and the pharyngeal size of snoring children with obstructive tonsils from the waiting list for surgery treated with the bioajusta x orthodontic appliance.this new protocol of orthodontic treatment promotes maxillary expansion, mandibular advancement and proper tongue positioning on swallowing , that together may be helpful on remodeling the upper airways.

methods-the study population included 40 children, ranging in age from 6 to 9 years old, who were on the waiting list for adenotonsillectomy at the ent department of fmusp. the patients were randomly divided into two groups and were subsequently compared after a six month interval. the first group included 24 patients who where treated with the bioajusta x appliance and the second group included 16 patients who served as controls, and,thus, did not received any treatment. cephalometric analysis was used to assess the growth direction by comparing the relationship of the vertical jaw based upon the angle of the palatal plane with the mandibular plane (ans-pns/go-m).pharyngeal size was measured using acoustic pharyngometry. the parents filled out a questionnaire with respect to the respiratory symptoms of their children.

Eligibility criteria:
inclusion criteria: * children 6 to 9 years of age with tonsils degree 3 or 4 , * sleep snores and narrow maxilla or class ii malocclusion. exclusion criteria: * neurological diseases, * tooth missing , * previous orthodontic treatment.

Keywords: sleep apnea syndrome orthodontics tonsillectomy child
epidemiological investigation of crbsi, vap, cauti in chinese icu

Conditions: Nosocomial Infection

Summary: the current protocol desires to implement a large-multicenter observational study of hospital acquired infection in icu in china. the study will generate data on generate data about the epidemiology current management of nosocomial infection.

the objectives are as followings: 1. obtain incidence of three major nosocomial infection in icu, catheter related blood stream infection(crbsi), catheter related urinary tract infection (cruti), and ventilator associated pneumonia (vap). 2. determine the epidemic of etiology and condition of management of three major nosocomial infection in icu in china.

Eligibility criteria:
inclusion criteria:all patients admitted into icu
application of nutritional ultrasound in the diagnosis and follow-up of patients with nutritional risk: dreco study

Conditions: Nutrition Disorders; Malnutrition

Summary: disease-related malnutrition (drm) can occur when there is a deficient supply of energy, protein and/or other nutrients, depending on the nutritional needs of each individual at different times of their life cycle or health or disease circumstances. this deficiency induces effects on body composition and tissue and organ function and results in clinical consequences: increased morbidity and mortality associated with different disease processes. there are techniques for nutritional assessment using assessment tools aimed at morphofunctional diagnosis of malnutrition, in addition to the classical nutritional parameters, such as weight loss, bmi, folds, circumferences, albumin, lymphocytes, cholesterol and intake. new advanced parameters are being incorporated into clinical nutrition and their incorporation into clinical practice is of increasing interest, such as measures derived from bioelectrical impedance (bia) and phase angle (pha), dynamometry, functional tests, crp/prealbumin ratio and muscle ultrasound. in 2019, the glim criteria were published, providing a different vision of how to assess the malnourished patient. phenotypic criteria include reduction in muscle mass (measured using validated techniques to measure body composition). the objective of the study is to highlight nutritional ultrasound for measuring muscle and functional status in order to make a more accurate diagnosis and a better prediction of complications and morbidity and mortality in this type of patients.

prospective, multicenter, uncontrolled clinical study, of routine clinical practice, without drugs or medical devices

Eligibility criteria:
inclusion criteria: * patients admitted to hospital who in the first week of admission have moderate or high risk of malnutrition according to the must and sarc-f screening test using r-mapp. appendix * patient aged 18 to 85 years. * patient who agrees to participate in the study and signs the informed consent. exclusion criteria: * hepatic impairment (ast/alt 3 x upper limit of normal) * chronic kidney failure (gfr \<45 ml/min) * patient with previous icu stay during the study admission. * cancer patients on palliative treatment or ecog (eastern cooperative oncology group) ≥ 3. * orthopaedic disease that does not allow adequate walking * patients with known dementia or others not related to a significant neurological or psychiatric disorder, or any other psychological condition that may interfere with the conduct of the study. * patients with eating disorders * life expectancy of less than 6 months. * patients unable to adequately complete the clinical laboratory assessments required for the study protocol.

Keywords: ultrasonography malnutrition clinical nutrition disease related malnutrition
efficacy of prophylactic clip application in decrease of immediate postpolypectomy bleeding and delayed postpolypectomy bleeding after colonoscopic removal for a large pedunculated polyps

Conditions: Polyp of Large Intestine

Summary: the aim of this study is to evaluate the efficacy of prophylactic clip application after colonoscopic removal for a large pedunculated polyp (\> 1cm) in preventing immediate postpolypectomy bleeding (ippb) and delayed postpolypectomy bleeding (dppb).


Eligibility criteria:
inclusion criteria: * patients who have a large pedunculated polyp(\>1cm) in the colon exclusion criteria: * age under 20 years * subjects who are taking anticoagulants * subjects who have an abnormal coagulogram (platelet count, international normalized ratio, or activated partial thromboplastin time) * subjects who have inflammatory bowel diseases

Keywords: colon polyp endoscopic polypectomy postpolypectomy bleeding prophylactic clip application
evaluation of lbl-019 monotherapy or combined with anti-pd-1 antibody in the treatment of advanced malignant tumors

Conditions: Advanced Malignant Tumors

Summary: this trial is a phase i/ii study, which is designed to evaluate the safety, tolerance, pharmacokinetic characteristics, receptor occupancy (ro), immunogenicity and effectiveness of lbl-019 monotherapy or combined with anti-pd-1 antibody in patients with advanced malignant tumors.

this trial is a phase i/ii study , which is designed to evaluate the safety, tolerance, pharmacokinetic characteristics, receptor occupancy (ro), immunogenicity and effectiveness of lbl-019 monotherapy or combined with anti-pd-1 antibody in patients with advanced malignant tumors. approximately 244-486 subjects with advanced malignant tumors will be enrolled. the study was divided into two phases: phase i (part a single therapy dose escalation and part b combination therapy dose escalation) and phase ii (part a single therapy dose expansion and part b combination therapy dose expansion) .

Eligibility criteria:
inclusion criteria: 1.agree to comply with the trial treatment plan and visit plan, voluntarily agree to sign the informed consent form; 2.18-75 years old (including boundary value), no gender limit; 3. previous standard treatment failed, no standard treatment or standard treatment is not applicable at this stage; 4.the expected survival time is at least 12 weeks; exclusion criteria: 1. have received chemotherapy, radiotherapy, biological therapy, endocrine therapy, immunotherapy and other anti-tumor treatments within 4 weeks before using the study drug for the first time； 2. received any other investigational drug or treatment that is not on the market within 4 weeks prior to the initial use of the investigational drug; 3. women who are pregnant or breastfeeding; 4. the investigator believes that the subject has other conditions that may affect compliance or are not suitable for participating in the study
isotretinoin in papular-pustular rosacea

Conditions: Papular-pustular Rosacea

Summary: a national, multicentre, prospective, randomised, double-blind, phase iii study in 2 parallel groups of isotretinoin versus placebo in patients presenting papular-pustular rosacea resistant to standard therapy. a non-balanced group (2 isotretinoin /1 placebo) design was selected since, given the nature of the study disease, fewer patients will receive the placebo than active isotretinoin. treatment duration for each patient : 4 months, with monthly evaluation follow-up at 2 months and 4 months for patients responsive after 4 months of treatment.


Eligibility criteria:
inclusion criteria: * adult * patients presenting papular-pustular rosacea (characterised by at least 8 lesions (papules and/or pustules) * resistant for at least 3 months in the last two years to standard treatment comprising systemic antibiotics (cyclins) with or without topical therapy * full compliance with a two-week wash-out period for all other topical and systemic treatments for rosacea at the time of selection * for women of childbearing age, use of a minimum of one "effective" contraceptive method for at least one month and willingness to continue using an effective contraceptive method continuously throughout the study duration and for at least one month after the end of treatment. * women of childbearing age must provide consent for pregnancy testing before the start of treatment, monthly throughout treatment and 5 weeks after the end of treatment. * negative pregnancy test results from within the last 3 days (for female subjects of childbearing age) * no laboratory abnormalities in standard tests * social security medical cover * provision of written and dated informed consent to take part in the study exclusion criteria: * patients already receiving isotretinoin for rosacea or within the last 12 months for acne * patients presenting perioral dermatitis * patients presenting miliary lupoid * patients presenting cortisone-induced rosacea * pregnant or breast-feeding women * patients with repeated and habitual heavy physical activity * patients with known hepatic impairment presenting cytolysis as attested by laboratory results * patients presenting hyperaemia * patient presenting hypervitaminosis a * patients with a history of hypersensitivity to isotretinoin * patients with allergy to soy oil * patients on tetracycline * patients with depression treated at the time of selection * patients currently taking part in having taken part in another study in the last 3 months prior to inclusion in the present study * patients protected by law (under guardianship or trusteeship) * patients unable to comply with the study requirements
comparison of the safety of q8003 versus morphine equivalent doses of its components (oxycodone and morphine) in bunionectomy patients

Conditions: Postoperative Pain

Summary: this is a randomized, double-blind, multicenter, repeat-dose study of fixed doses of q8003 12 mg/8 mg given q6hr compared to morphine sulfate 24 mg and oxycodone hydrochloride 16 mg given q6hr for the management of acute moderate to severe postoperative pain for 48 hours following bunionectomy surgery.


Eligibility criteria:
inclusion criteria: * patient is male or female and at least 18 years of age. * females must be non-pregnant, non-lactating, and practicing an acceptable method of birth control, or be surgically sterile or postmenopausal (amenorrhea for ≥ 12 months). non-pregnancy will be confirmed by pregnancy tests conducted at screening and pre-treatment. * patient is scheduled for bunionectomy surgery, meets the criteria of an asa class i to iii, and is willing to stay in the study center for at least 48 hours from the initial dose of study medication post surgery. * to be randomized after surgery, the patient must report moderate to severe pain (a score of 2 or more on the 4 point likert scale or 4 or more on the 11 point nprs scale). * at least 40% of study subjects will be 60 years of age or older. exclusion criteria: * in the opinion of the investigator, has a history of pulmonary, cardiovascular (including uncontrolled hypertension), neurologic, endocrine, hepatic, gastrointestinal, or kidney disease or therapy that would jeopardize the patient's well being by participation in this study or is mentally or emotionally unsuitable to participate, or unable/unwilling to comply with the study assessments. * used opiates continuously (including tramadol) for more than ten days in the past year. * hypersensitivity or poor tolerance to acetaminophen. * currently receiving any medications that are not at a stable dose (the same dose for \> 2 months prior to date of surgery). * was dosed with another investigational drug within 30 days prior to the screening visit or has previously received treatment with q8003. * current therapy with central nervous system depressant medications that might increase the risks of treatment with opioids (other than those used with surgical anesthesia). * current evidence of alcohol abuse (regularly drinks more than 4 units of alcohol per day; 1 unit = ½ pint of beer, 1 glass of wine, or 1 ounce of spirit).

Keywords: bunionectomy