Kornimate/medical-research-clean huggingface dataset:
carbetocin versus oxytocin infusion plus tranexamic acid during cesarean section

Conditions: Cesarean Section Complications

Summary: purpose to evaluates the effects of oxytocin infusion with or without intravenous tranexamic acid (ta) in comparison with carbetocin for prevention of postpartum hemorrhage at a cesarean section with one or more risk factor for postpartum hemorrhage.

postpartum hemorrhage (pph) is potentially life-threatening and is a significant contributor to maternal mortality and morbidity especially in developing countries. the risk of pph is much higher for women undergoing cesarean delivery (cd). oxytocin is regarded as the gold standard uterotonic agent but only has a half-life of 4-10 min; therefore, at cesarean section oxytocin must be administered as a continuous intravenous infusion to attain sustained uterotonic activity throughout the surgical procedure and immediate postpartum period. carbetocin is a long-acting synthetic analog of oxytocin that can be administered as a single-dose injection; intravenously administered carbetocin has a half-life of approximately 40 min. a single intravenous bolus of carbetocin produces a tetanic uterine contraction within 2 min and persists for an average of 60 min following injection. the aim of this study is to compare the effectiveness of combined tranexamic acid (ta) and oxytocin infusion with intravenous carbetocin for prevention of pph in patients with risk factors during cesarean section.

Eligibility criteria:
inclusion criteria: * women who undergo elective cesarean section with one or more risk factors for pph were the candidates for participation * with fetal macrosomia, polyhydramnios, low insertion of the placenta, multiple gestations, prolonged labor, chorioamnionitis, past history of pph, diabetes and high parity (5 previous deliveries). exclusion criteria: * suspected coagulopathy, * history of coronary artery disease or hypertension, * women with a history of hypersensitivity to carbetocin, ta or oxytocin * general anesthesia, and * pph due to causes other than uterine atony.

Keywords: cesarean section tranexamic acid oxytocin carbetocin
prone position effects on work of breathing and intrinsic peep in children with severe acute viral bronchiolitis

Conditions: Severe Bronchiolitis

Summary: acute viral bronchiolitis is the first cause of respiratory distress in infant. airway inflammation increases the respiratory system resistances and dynamic hyperinflation. this leads to an increase in the work of breathing. in chronic obstructive pulmonary disease patients as in neonates, prone position (pp) improves lung function and decreases the end expiratory lung volume. the investigators hypothesized that in infants with severe bronchiolitis, prone position reduces the intrinsic positive end expiratory pressure (peepi) and the work of breathing (wob). the investigator designed a prospective randomized crossover study with 16 infants younger than six months who need ventilatory support by nasal continuous positive airway pressure (ncpap) for severe acute viral bronchiolitis. work of breathing (product time pressure) and peepi will be estimated using an esophageal pressure probe in prone and supine position.


Eligibility criteria:
inclusion criteria: * infant \< 6 months * admitted in the pediatric intensive care unit of the femme-mère-enfant hospital, hospices civils de lyon, france * with severe acute viral bronchiolitis requiring ventilatory support (mwcas \> 4 and/or and or fio2\> 40% and/or hypercapnic acidosis (ph\ 8 kpa)) * signed informed consent by the two parents or the owner of parental authority exclusion criteria: * chronic respiratory, neuromuscular, ent or cardiac disease * contraindication for placement of esophageal probe (esophageal surgery, varices, ...) * children requiring invasive ventilation (more than 3 significant apneas in 1 hour, decreased consciousness, ...) * children not affiliated to a social security scheme

Keywords: children. prone position acute viral bronchiolitis syncytial virus work of breathing intrinsic peep
mri and pet-ct for radiotherapy planning for head and neck cancer

Conditions: Head and Neck Cancer

Summary: radiotherapy is commonly used to treat advanced cancers of the head and neck, aiming for cure while preserving patients' quality of life including their ability to speak and swallow. in order to reduce the potentially major side effects of treatment, it is essential that the highest doses of radiotherapy are targeted to the main bulk of the tumour. at present a computerized tomography (ct) scan is used by the cancer specialist to identify the tumour for planning the radiotherapy treatment. the investigators know that other types of scan including magnetic resonance imaging (mri) and positron emission tomography (pet) scans are better than ct scans at showing areas involved by the cancer. however, radiotherapy cannot be directly planned on these types of scans. the aim of this study is to explore whether pet and mri scans can be combined with ct scans to more accurately identify the tumour target. in addition, this study will explore whether petct and mri scans may used to adjust radiotherapy to how well a tumour is responding during a course of radiotherapy. if the radiotherapy planning process can be improved in these ways, the investigators hope future patients will benefit by more chance of cure with a reduction in the side effects of treatment. the study aims to recruit 16 patients. all patients within the study will undergo a petct and an mri scan prior to starting treatment as part of the study. a subgroup of 8 patients will undergo additional imaging at two timepoints during the course of their radiotherapy. the study is noninterventional and patients' standard treatment will not be affected by their participation in the study.


Eligibility criteria:
inclusion criteria: * age ≥18 * who performance status 02 * histologically proven squamous cell carcinoma of the head and neck region * clinical decision made to proceed with a course of radiotherapy of curative intent of 6670gy in 3335 fractions over six and a half to seven weeks with or without concurrent chemotherapy * measurable primary tumour and/or locoregional metastatic lymph nodes on preradiotherapy imaging * able to provide fully informed written consent * able to lie flat for 1 hour * not be pregnant or breast feeding. female patients of childbearing potential must agree to use effective contraception, be surgically sterile, or be postmenopausal. exclusion criteria: * hypersensitivity to fluorine-18 fdg * hypersensitivity to iodinated contrast media or gadolinium * poorly controlled diabetes * acute renal failure or moderate renal impairment (estimated glomerularb filtration rate \< 30 ml/min) * contraindication to mri imaging, including cardiac pacemaker or presence of mri incompatible metalwork * claustrophobia precluding mri imaging * uncontrolled pain * urinary incontinence * female patients must not be pregnant and if of child bearing age using adequate contraception * breast feeding * serious psychiatric comorbidity
palliative strategies in spinal cord injury (sci)

Conditions: Spinal Cord Injury

Summary: spinal cord injury (sci) leads to muscle atrophy, hyperreflexia and spasticity, symptoms that decrease quality of life and prevent effective rehabilitation. previous findings from our labs found that a passive cycling exercise program, motorized bicycle exercise training (mbet), in adult spinally transected animals reduced muscle atrophy and normalized hyperreflexia. we found that mbet could prevent the onset of hyperreflexia after spinal transaction, that mbet could also be used to rescue from hyperreflexia once it had set in, and that mbet could induce savings in normalization of reflexes after mbet ceased. we also demonstrated that mbet was effective in rescuing from hyperreflexia in a chronic asia b sci patient, and that short-term mbet could lead to brief savings in normalization of reflexes once mbet ceased. the proposed studies will test the ability to mbet to prevent the onset of hyperreflexia in a group of acute sci patients trained before hyperreflexia has had a chance to set in. in addition, the proposed research will attempt to confirm the possibility that long-term mbet in chronic sci patients will rescue from hyperreflexia once it has set in, and also produce significant savings in normalization of reflexes if carried out for long periods of time. we will also test the possibility that mbet in acute and/or chronic sci patients could reduce or prevent muscle atrophy. the experimental design calls for assessing muscle mass using mri scans, bone density using dual-energy x-ray absortiometry (dexa) scans, spasticity measures and electrophysiological measurements to determine low frequency habituation of the h-reflex. assessments will be carried out before mbet, during a 25 week mbet block of time, and during a 12 week post mbet monitoring period. changes in muscle mass, bone density, spasticity scales and h-reflex habituation will be compared across these interventions and between treated sci victims and a group of control acute and chronic sci victims undergoing standard of care during the same period.


Eligibility criteria:
inclusion criteria: * 1. an incomplete spinal cord injury at a level of c4 to t12. * 2. 18 to 70 years of age. exclusion criteria: * 1. joint contractures and/or spasticity that would hamper upright posture or use of mbet * 2. a documented blood clot in the lower extremities * 3. a history of lower extremity fractures (excludes randomization to the pwbt). * 4. pregnant women

Keywords: spinal cord injury
on the impact of therapeutic tumor necrosis factor-alpha inhibition on anogenital human papillomavirus infection

Conditions: Psoriasis; Inflammatory Bowel Diseases

Summary: in this prospective, open, controlled, cross-sectional observational study patients with psoriasis or ibd, who received either anti-tnf-alpha inhibitors or alternates (purine-, folic acid analogues, phototherapy, fumaric ester, mesalazine) for their underlying disease were included. anogenital hpv-induced lesions, mucosal hpv dna and serological status of mucosal low-risk (hpv6) and high-risk hpv (hpv16, hpv18) were determined.

in this prospective, open, controlled, cross-sectional observational study patients with psoriasis or inflammatory bowel diseases (ibd), who received either tumor necrosis factor-alpha (tnf-alpha) inhibitors or alternates (purine-, folic acid analogues, phototherapy, fumaric ester, mesalazine) for their underlying disease were included. patients were assigned to the following subgroups according to their current therapy for ≥ 6 months: i) tnf-alpha inhibitor monotherapy; ii) monotherapy with purine or folic acid analogues, such as azathioprin, 6-mercaptopurine, or methotrexate iii) combination therapy with tnf-alpha blocker plus purine or folic acid analogues; iv) alternate therapy, such as phototherapy, fumaric acid, mesalazine. the last group additionally included patients that were without any therapy. information about duration and severity of illness, current and former disease-related medical treatment, smoking habits and sexual history with emphasis on preexisting human papillomavirus (hpv) infection, including anogenital warts or previous abnormal cervical cytology, and hpv vaccination status were obtained for each patient. swab samples were taken at one time point from the penile shaft and glans of men, the vulva and cervix in women, and the perianal region of both genders. detection of mucosal human papillomavirus dna in the samples was performed using the fda-approved digene hybrid capture 2 kit. cervical papanicolaou (pap) smears were collected by cytobrush from female patients at the same time. blood for determination of serological status was drawn from each patient and peripheral blood mononuclear cells and serum obtained.

Eligibility criteria:
inclusion criteria: * participants between 18-80 years of age with a history of psoriasis or inflammatory bowel diseases, namely crohn's disease and ulcerative colitis, and * at least 6 month of continuous treatment regimen. exclusion criteria: * pregnant or nursing patients and * patients with inherited immune disorders, human immunodeficiency virus infection, invasive malignancies or psychomotor retardation and * patients with psoriasis or inflammatory bowel diseases who had received high-dose corticosteroids during the past 6 months.
study of e7777 in patients with relapsed or refractory peripheral t-cell lymphoma and cutaneous t-cell lymphoma

Conditions: Peripheral T-cell Lymphoma; Cutaneous T-cell Lymphoma

Summary: the purpose of this study is to evaluate the objective response rate (orr) of e7777 in participants with relapsed or refractory peripheral t-cell lymphoma (ptcl) and cutaneous t-cell lymphoma (ctcl).

this is a multicenter, single-arm, open label, phase 2 to evaluate efficacy, safety, pharmacokinetics and immunogenicity of e7777 in participants with relapsed or refractory ptcl and ctcl.

Eligibility criteria:
inclusion criteria: 1. participants who have histological diagnosis as peripheral t-cell lymphoma (ptcl) and cutaneous t-cell lymphoma (ctcl). 2. participant who have measurable disease. 3. participant who had previous systemic chemotherapy. 4. participant who had disease progression (pd) or did not have response (complete response (cr) or partial response (pr)) in systemic chemotherapy, or relapsed or progressed after systemic chemotherapy. 5. participant with eastern cooperative oncology group (ecog) performance status (ps) 0 or 1. 6. participant with adequate renal, liver and bone marrow function. 7. male and female participants ≥20 years of age at the time of informed consent. 8. participants who have provided written consent to participate in the study. exclusion criteria: 1. participant with serious complications or histories. 2. participant with history of hypersensitivity to protein therapeutics. 3. participant who is positive for human immunodeficiency virus (hiv) antibody, hepatitis c virus (hcv) antibody, or hepatitis b surface (hbs) antigen. 4. participant with malignancy of activity other than ptcl or ctcl within 36 months before informed consent. 5. women of childbearing potential or man of impregnate potential who don't agree to use a medically effective method for contraception. 6. woman who is pregnant or lactating. 7. participant with allogeneic stem cell transplantation. 8. participant who were decided as inappropriate to participate in the study by the investigator or sub-investigator.

Keywords: peripheral t-cell lymphoma cutaneous t-cell lymphoma e7777 phase 2
a clinical study of lm103 injection in the treatment of advanced solid tumors

Conditions: Melanoma; Non Small Cell Lung Cancer; Cervical Carcinoma

Summary: this is a single-arm, open-label, exploratory study to evaluate safety and efficacy of lm103 injection in patients with advanced solid tumors. the purpose of this study is to evaluate the safety and tolerability, antitumor activity and immunoreactivity.

this is an investigator initiated , single-arm, open-label ,exploratory study of lm103 injection in patients with advanced solid tumors. expanded tils will be transferred to the patient after chemotherapy with cyclophosphamide and fludarabine. lm103 will be administered as a single dose on day 1. til transfer will be combined with il-2 treatment. this study is planned to enroll 9-15 patients with advanced solid tumors.

Eligibility criteria:
inclusion criteria: 1. ajcc (v8) stage iii or iv melanoma, non-small cell lung cancer, cervical cancer and other solid tumors (confirmed by histology) for which existing treatment is ineffective or without standard treatment; 2. the patient has residual lesions that can be used for surgical resection (\>1.5cm3) or biopsy (\>1.5cm3) and measurable after resection for til collection and efficacy evaluation; 3. laboratory inspection index requirements: * blood routine: lymphocyte ratio \> 20%; neutrophil count \> 1.0 × 10\^9/l; white blood cells \> 3.0 × 10\^9/l; platelets \> 100 × 10\^9/l; hemoglobin \> 80 g/ l; * liver function: alanine aminotransferase (alt) and aspartate aminotransferase (ast) ≤ upper limit of normal x 2.5, if there is liver metastasis ≤ upper limit of normal x 5; alkaline phosphatase (alp) ≤ upper limit of normal x 2.5; total gallbladder red pigment (tbil)≤normal upper limit×1.5; * renal function: urea ≤ upper limit of normal × 1.5; creatinine (cr) ≤ upper limit of normal × 1.5; 4. left ventricular ejection fraction (lvef) ≥ 50%; 5. ecog physical condition is 0 or 1; 6. the expected survival time is more than 3 months; exclusion criteria: 1. suffering from active or previous autoimmune diseases ; 2. severe liver and kidney dysfunction, severe heart disease, coagulation dysfunction, and hematopoietic dysfunction; 3. combined with severe infection or persistent infection and cannot be effectively controlled; 4. central nervous system metastasis and/or cancerous meningitis; 5. with uncontrolled pleural effusion, pericardial effusion or ascites requiring repeated drainage; 6. requires systemic steroid therapy; 7. positive for hepatitis b surface antigen (hbsag) or hepatitis b core antibody (hbcab); positive for hepatitis c virus (hcv) antibody; positive for human immunodeficiency virus (hiv) antibody; positive for syphilis;
a study to reduce persistent post-mastectomy pain using opioid-free anesthesia

Conditions: Breast Cancer; Mastectomy; Pain, Chronic; Pain, Post Operative

Summary: in 230 patients undergoing mastectomy, the investigators will compare opioid-free anesthesia (ofa) versus conventional opioid-based anesthesia in terms of chronic pain. the enrolled patients will be randomly assigned into two groups with 1:1 ratio. chronic pain will be evaluated at 1 year after mastectomy based on the breast cancer pain questionnaire (bcpq). baseline pain sensitivity test and psychologic evaluation will be done before operation.

study population 1. all of patients will undergo mastectomy with or without immediate breast reconstruction. 2. 230 patients will be enrolled. intervention 1. ofa group will be sedated using dexmedetomidine and lidocaine. 2. conventional opioid anesthesia group will be sedated using remifentanil. pain screening 1. breast cancer pain questionnaire (bcpq) 2. pain-detect, hads, eq-5d, phq-15 (somatic symptom), pcs (pain catastrophizing), bfi (big five inventory), ham-a\&d, pressure algometry (pain sensitivity), quantitative sensory test (pinprick)

Eligibility criteria:
inclusion criteria: * all of patients will undergo mastectomy with or without immediate breast reconstruction. exclusion criteria: * previous history of breast surgery * allergy to drug * other cancer history * underlying psychologic disorder * patients with chronic pain requiring pain killers * baseline spo2 \<95% * left ventricular ef \<40% * bradycardia as hr \<50 bpm * bmi \>35kg/m2 * pregnant woman
relationship of noninvasive assessment of central bp with 10 years atherosclerotic cvd in subclinical hypothyroidism

Conditions: Subclinical hypothyroïdism

Summary: verify relationship of noninvasive assessment of central arterial blood pressure with 10 years atherosclerotic cardiovascular disease (ascvd) in subclinical hypothyroidism

subclinical hypothyroidism (sch), characterized by elevated thyrotropin (tsh) levels with normal free thyroxine (t3,t4) concentrations, is a prevalent disorder affecting approximately 10% of the adult population. it has been increasingly recognized for its potential impact on cardiovascular health. a 10-year follow-up study highlighted a significant association between elevated serum tsh levels and increased cardiovascular (cv) risk, independent of conventional risk factors. and it demonstrated its association with hypercholesterolemia and atherosclerosis as the leading risk of cvd. moreover, in a recent meta-analysis, subclinical hypothyroidism was shown actually be correlated with an increased risk of cvd and mortality. monitoring thyroid function underscores the potential importance of cardiovascular (cv) risk assessment, for patients with subclinical hypothyroidism (sch). incorporating thyroid function tests, such as tsh and free thyroxine (ft4) levels, alongside non-invasive central arterial blood pressure monitoring, provides a comprehensive understanding of a patient\&#39;s cv risk. this integrated approach enables early identification and targeted interventions, ultimately improving patient outcomes and reducing the incidence of cvd among those with sch. one of the earliest functional changes underlying ascvd is arterial stiffening it reflects a variety of pathologies, including atherosclerosis. as an important determinant of cardiovascular health, arterial stiffness can contribute to increased blood pressure and reduces vessels\&#39; capacity to buffer the pulsatile flow when the heart contracts, which are significant risk factors for predicting ascvd. for continuous non-invasive central arterial blood pressure monitoring, the auscultatory method or the oscillometric technique can be used. these methods provide valuable insights into the health of the central arteries, which are crucial in understanding the cardiovascular risk profile of patients with sch.

Eligibility criteria:
inclusion criteria: * age 18-70 * both sex exclusion criteria: * patients had thyroidectomy operation * patients with a history of encompassing acute coronary syndrome (acs). * myocardial infarction (mi). * coronary heart disease (chd). * cerebrovascular diseases or other arterial revascularization
developing a prep adherence intervention targeting at-risk and substance using women

Conditions: HIV/AIDS

Summary: the purpose of this study is to develop and assess the feasibility, acceptability, and preliminary efficacy on adherence of a community-informed intervention for tenofovir/emtricitabine (tdf/ftc) pre-exposure prophylaxis (prep) engagement among street-based female sex workers (fsw) in baltimore, maryland.

this study is a prospective two-group trial comparing the efficacy of a comprehensive prep adherence program compared to prep standard of care among fsw. outcomes will be assessed through self-reported prep adherence as well as biological adherence indicators. the intervention includes three main components: 1) group prep engagement sessions, which include four educational sessions that situate prep in a broader framework of access and barriers to care, provider/patient communication, sexual health, hiv/sexually transmitted infection (sti) education, harm reduction around drug use, stigma, risk compensation and safe sex, and health/science literacy; 2) peer navigation, which aims to help women navigate healthcare engagement with the sparc nurse practitioner and other providers; and 3) an mhealth component, consisting of a two-way text messaging system through which women will receive automated daily messages and weekly messages requesting adherence reports.

Eligibility criteria:
inclusion criteria: * age 18 or older * assigned female at birth and identify as a woman * traded sex for money or drugs at least three times in the past three months * hiv negative * willing to initiate prep * not knowingly pregnant or planning to become pregnant during the following 6 months. exclusion criteria: * currently taking prep for hiv prevention * inability to provide informed consent in english * women who are determined as too high or drunk * women who are cognitively impaired * does not agree to data sharing with the baltimore city health department