Kornimate/medical-research-clean huggingface dataset:
a study to assess the efficacy and safety of tc-5214 as an adjunct therapy in patients with major depressive disorder.

Conditions: Major Depressive Disorder

Summary: the purpose of this study is to determine if tc-5214 or placebo (a tablet that looks like a medicine tablet or capsule, but contains no active medicine) is safe and effective when taken together with another antidepressant.

a multicenter, randomized, double-blind parallel group placebo-controlled phase iii, efficacy and safety study of 3 fixed dose groups of tc-5214 (s-mecamylamine) as an adjunct to an antidepressants in patients with major depressive disorder who exhibit an inadequate response to antidepressant therapy

Eligibility criteria:
inclusion criteria: * provision of signed and dated informed consent before initiation of any study-related procedures. * the patient must have a clinical diagnosis of major depressive disorder (mdd) with inadequate response to no more than one antidepressant. * outpatient status at enrollment and randomization. exclusion criteria: * patients with a lifetime history of bipolar disorder, psychotic disorder or post-traumatic stress disorder. * patients with a history of suicide attempts in the past year and/or seen by the investigator as having a significant history of risk of suicide or homicide. * history of renal insufficiency or impairment or conditions that could affect absorption or metabolism of investigational product.

Keywords: major depressive disorder, mdd, depression
vectron t500 (broflanilide 50wp) for irs in tanzania tanzania

Conditions: Malaria,Falciparum

Summary: malaria is a major public health problem in africa. an important way to control the disease is by indoor residual spraying of insecticide in houses. insecticide resistance has become a major problem. this trial will evaluate a novel insecticide against those insecticide resistant mosquito vectors in tanzania e africa.

background: indoor residual spraying (irs) is one of the major methods of malaria vector control across sub-saharan africa, responsible for reducing malaria incidence by 10% since 2000. however, effective vector control is increasingly threatened by the rapid spread of insecticide resistance. consequently, there have been investments in the development of new insecticides for irs that possess novel modes of action with long residual activity, low mammalian and environmental toxicity and minimal cross-resistance. vectrontm t500, a new irs insecticide containing the active ingredient broflanilide 50% wp, has been shown to be efficacious against both pyrethroid-susceptible and -resistant vector strains on mud and concrete substrates in phase ii experimental hut trials in tanzania. method: a two-arm non-inferiority cluster randomized controlled trial will be conducted in muheza district, tanga region, tanzania. vectrontm t500 will be compared to the irs formulation fludora® fusion (active ingredients: clothianidin 50% wp + deltamethrin 6.25% wp). the predominant malaria vectors in the study area are pyrethroid-resistant anopheles gambiae s.s., an. arabiensis and an. funestus s.s. sixteen selected clusters of 75-200 households in each cluster will be pair-matched on baseline vector densities and allocated to reference and intervention arms. consenting households in the intervention arm will be sprayed with vectrontm t500 and those in the reference arm will receive fludora® fusion. monthly cdc light traps will collect mosquitoes to determine vector density, indoor biting, sporozoite and entomological inoculation rates (eir). phenotypic resistance to irs active ingredients will be assessed using cdc bottle bioassays. molecular and metabolic resistance mechanisms will be characterised among anopheles field populations from both trial arms. residual efficacy of both brands of insecticide will be monitored for 12 months post-spraying. a semi-structured questionnaire and focus group discussions will explore social and cultural factors that influence acceptability, perceived adverse effects and benefits of irs. discussion: this protocol describes a phase iii non-inferiority evaluation of a novel irs product to reduce the density and eir of pyrethroid-resistant anopheles vectors. if vectrontm t500 proves non-inferior to fludora® fusion, it may be considered as an additional vector control product for malaria prevention and insecticide resistance management schemes.

Eligibility criteria:
inclusion criteria: all households who consent to irs malaria control exclusion criteria: none

Keywords: vector control insecticide indoor residual spraying of mosquitoes
optimal strategy for repair of type a acute aortic dissection

Conditions: Aortic Dissection

Summary: acute type a aortic dissection (taad) persists as a clinicopathologic entity with high lethality in the current era. several procedures are presently used to repair the taaad. the objective of this study is to analyze two groups of individuals using a conservative approach through root-sparing and hemiarch techniques in patients who are hospitalized in higher-risk clinical conditions or more aggressive procedures such as root replacement and total arch replacement in low-risk patients.

the target population enrolled in the registry includes patients with taaad.the high volume of patients that will be enrolled in this registry will receive proximal and distal aortic repair in elective, urgent or emergency clinical condition. efforts of investigators will be concentrated in taaad repair using a conservative approach of root preservation and hemiarch reconstruction in the majority of patients who will be referred in critical clinical condition. high-risk patients with older age or more comorbidities had more conservative repairs to limit surgical insult to these complicated patients. total arch reconstruction and root replacement will be optional procedures for specific subgroups of patients who may benefit from a more complex index finger operation without incurring additional immediate risk. investigators hope to demonstrate a reduction in operative mortality and an improvement in early and late outcomes. the experience of investigators will be summarized in an algorithm for taaad repair with an analysis of early morbidity and mortality, as well as late survival and no reoperation.

Eligibility criteria:
inclusion criteria: * taad or intramural hematoma involving the ascending aorta * patients aged \> 18 years * symptoms started within 7 days from surgery * primary surgical repair of acute taad * any other major cardiac surgical procedure concomitant with surgery for taad. exclusion criteria: * patients aged \< 18 years * onset of symptoms \> 7 days from surgery * prior procedure for taad * concomitant endocarditis; * taad secondary to blunt or penetrating chest trauma.

Keywords: type a acute aortic dissection (taaad) root-sparing replacement hemiarch procedures ascending aorta replacement total arch replacement (tarp) frozen elephant trunk (fet)
empagliflozin vs metformin on metabolic dysfunction in polycystic ovary syndrome with or without comorbidity or multimorbidity

Conditions: Polycystic Ovary Syndrome; Weight Gain; HbA1c

Summary: this is open labelled randomize control trial among women with pcos. pcos, an endocrine condition, affects 5%-15% of premenopausal women. pcos is characterized by atypical menstruation, ovulation difficulties, hyperandrogenemia, insulin resistance, and other metabolic abnormalities. metformin is now an option for pcos. the clinical reactions to metformin are limited and varied. novel sglt2 inhibitors treat type 2 diabetes with weight loss, insulin resistance reduction, and cardiovascular benefits. there is little evidence on sglt2 inhibitor effectiveness in pcos patients.


Eligibility criteria:
inclusion criteria: 1. all women participants belong to the reproductive age group, i.e., 18 to 45 years will be included in the study. 2. all those women of bmi of greater than 25 kg/m2 will be included in this study 3. women with a diagnosis of pcos by using two (hyperandrogenism and oligo-anovulation) out of three (oligo-anovulation, hyperandrogenism and polycystic ovaries) rotterdam criteria 2 which confirm hyperandrogenism (acne, seborrhea, hair loss on the scalp, increased body or facial hair) on clinical judgement will be included in the study 4. those who documented and self-reported oligomenorrhea (cycle length greater than 35 days and nine or fewer periods per year) will be included. or 5. those who report amenorrhea (absence of menses for a period of 3 months) will be inclusion criteria of the study. 6- pco women with or without comorbidity or multimorbidity specifically, hypothyroidism, diabetes, hypertension. - exclusion criteria: 1. women of non-classical 21-hydroxylase deficiency, hyperprolactinemia, cushing's disease, or androgen- secreting tumors will be streaked from participating. 2. in addition to this, pregnancy or intent to become pregnant, breastfeeding, documented use of oral hormonal contraceptives and hormone- releasing implants, clomiphene citrate or oestrogen modulators, gonadotropin-releasing hormone (gnrh) modulators and minoxidil will be excluded. 3. history or presence of malignant neoplasms within the last one years, pancreatitis (acute or chronic) will also be excluded from the study 4. women with recurrent complaint of urinary tract infection (uti)will be excluded from the study. -
the effects of lateral 45° downward position on the optic nerve sheath diameter

Conditions: Optic Nerve Sheath Diameter

Summary: trendelenburg position and carbon dioxide (co2) pneumoperitoneum are in association with increased intracranial pressure (icp) reflected by the optic nerve sheath diameter (onsd). measurement of onsd by ultrasound (us) guidance can be used in the diagnosis of icp. the investigators interrogated the effects of lateral 45° downward position and co2 insufflation on onsd in patients undergoing laparoscopic transperitoneal nephrectomy.

transperitoneal laparoscopic nephrectomy is a popular and increasingly used alternative to the laparoscopic retroperitoneal approach because of benefits such as minimal invasion, the transperitoneal path provides a larger working space and familiar anatomic landmarks. this technique requires a steep (35° to 45°) lateral downward (sld) position and a co2 pneumoperitoneum. sld may lead to pathophysiological changes such as pulmonary dysfunction with the formation of atelectasis and increasing airway pressure as well as ocular complications. these are firstly reported 2 patients with bilateral ischaemic optic neuropathy (ion) after a da vinci robotic-assisted procedure. sld has raised concerns that prolonged elevation of venous pressure in the head may increase the risk of developing ion. however, a few investigations have yet been made into intraoperative changes in intraocular pressure (iop) and optic nerve sheath diameter (onsd) - correlating with intracranial pressure (icp) - and their adverse ocular effects. the operative conditions get better the steeper the positioning, providing an excellent intraabdominal view and probably less bleeding. the hypothesis of the study is that patients placed in sld for several hours have a high risk for ocular changes and peri- and postoperative complications. the aim of this study was to investigate the influence of capnoperitoneum and permanent 45° sld on iop and onsd in patients undergoing laparoscopic transperitoneal nephrectomy. the investigators also analyzed the hemodynamic and respiratory parameters, duration of surgery during laparoscopic nephrectomy. perioperative and postoperative complications were also recorded.

Eligibility criteria:
inclusion criteria: * all patients older than 18 years who have undergone laparoscopic transperitoneal nephrectomy. exclusion criteria: * those who have neurological and cerebrovascular disease.

Keywords: carbondioxide pneumoperitoneum optic nerve nephrectomy
dpbrn longitudinal study of dental restorations placed on previously un-restored surfaces

Conditions: Dental Caries

Summary: the purpose of this study is to assess the quality and expected lifespan of fillings recorded in the dpbrn "reasons for placing the first restoration on permanent tooth surfaces" study, and the factors affecting how long the fillings last.

this study is an observational follow-up of previously placed dental restorations (fillings) and is conducted during routine dental care visits.

Eligibility criteria:
inclusion criteria: * participant in the dpbrn "reasons for placing the first restoration on permanent tooth surfaces" study

Keywords: dental caries assessments dental materials
feasibility and outcomes of allogeneic hct compared to chemotherapy in older aml patients

Conditions: Acute Myeloid Leukemia (AML); Myelodysplastic Syndrome (MDS)

Summary: the purpose of this study is to compare treatment methods and outcomes of patients diagnosed with acute myeloid leukemia (aml) and myelodysplastic syndrome (mds).

this is a prospective multicenter observational study in a consortium of collaborating institutions investigating how often older and medically infirm patients who are diagnosed with acute myeloid leukemia (aml) or high-risk myelodysplastic syndromes (mds) and treated with induction chemotherapy undergo allogeneic hct. investigators will look at the rate of undergoing allogeneic hct among older and medically infirm aml and high-risk mds patients compared to younger and relatively healthier patients. investigators will also compare the characteristics and outcomes of patients who did versus did not proceed to allogeneic hct. a number of outcomes will be assessed including mortality, morbidity, and quality of life (qol). baseline information will be collected on different domains of qol, geriatric assessment, health status measures, aml features, and socioeconomic status. information will help physicians and patients to decide on best treatment choices for aml and high-risk mds in older and medically infirm patients.

Eligibility criteria:
inclusion criteria patients with new diagnoses of non-m3 aml or high-risk mds, myeloproliferative neoplasms (mpn), or myelofibrosis (mf) (showing 10% or more blasts in bone marrow) who: * present for an aml-like treatment that could plausibly produce a complete remission (cr); for example intensive induction chemotherapy, low dose single agent chemotherapy, hypomethylation agent, or a similar therapy * possibility to retrieve follow-up records from the collaborating institution or treating primary care physician * patients with primary refractory or first relapse presenting for salvage chemotherapy will be allowed * patients of 18 years of age or older, and are being treated by the adult aml service. * able to speak and read english. * willing and able to provide informed consent. exclusion criteria * patients of ≤17 years of age or who are 18 or older and receive treatment under the pediatric aml service. * patients older than 80 years * patients with \<6 months projected survival due to active second malignancy or other medical problem.
hfno improves blood oxygen saturation during asphyxia during pulmonary surgery with double-lumen endotracheal intubation

Conditions: Lung Neoplasms; Pneumothorax

Summary: with the continuous strengthening of the concept of rapid rehabilitation, great progress has been made in minimally invasive thoracic surgery, and thoracoscopic surgery has developed rapidly. double-lumen endotracheal(dlt) intubation is still the most reliable way of intubation in lung surgery. however, hypoxemia faced during double-lumen intubation still threatens the perioperative safety of thoracic surgery patients. in recent years, high-flow nasal oxygenation (hfno) has great potential in the field of anesthesia, especially playing a new and important role in the prevention and treatment of short-term hypoxia and life-threatening airway emergencies. however, the use of hfno in pulmonary surgery patients with poor pulmonary function lacks evidence-based basis, and there are few reliable clinical data. this study adopted a prospective, randomized, controlled, single-blind design. a total of 100 patients aged 18-60 years who underwent elective thoracoscopy-assisted pulmonary surgery were included and randomly divided into the experimental group: hfno was used in the process of double-lumen intubation asphyxia; the control group: according to the traditional intubation process, no oxygen therapy equipment was used during intubation asphyxiation. the lowest blood oxygen saturation during intubation, the incidence of hypoxemia during intubation, perioperative complications, and postoperative hospital stay were compared between the two groups. this study explores the advantages of hfno in complex endotracheal intubation, assuming that hfno can improve the oxygen saturation of double-lumen intubation; optimize the intubation method of dlt, and tap its new potential to prevent and manage emergency airway crisis.


Eligibility criteria:
inclusion criteria: * age 18-60; * patients planning to undergo video-assisted thoracoscopic (vats) lung surgery requiring dlt intubation; * patients who agreed to participate in this study. exclusion criteria: * american society of anesthesiologists (asa) classification \> iv; * patients with severe nasal obstruction; expected difficult intubation or difficulty with mask ventilation; * morbid obesity \[body mass index (bmi)\>35kg/m2)\]; * airway anatomical abnormalities; * abnormal coagulation function; * emergency surgery; * patients at high risk of reflux aspiration, including ileus, full stomach, esophageal reflux disease; * pregnant or breastfeeding women.
management of migraine using enerumab and traditional therapy at the time of covid-19

Conditions: Migraine Disorders

Summary: the objective of this study was to assess the efficacy of erenumab on frequency of monthly migraine days in adults at baseline, 3 months and 6 months, disability in patients with chronic migraine and on post covid migraine severity

migraine is a debilitating disorder that affects 37 million people in the united states. recently, three new injectables calcitonin gene-related peptide (cgrp) receptor antagonists-erenumab, fremanezumab, and galcanezumab-were fda approved for prophylactic treatment of migraine in adults, that plays a key role in migraine pathophysiology. by blocking the receptor function of cgrp, these agents can reduce the total number of headache days per month and limit the need for using multiple medications. in clinical trials, these agents, which have no drug interactions and minimal adverse reactions, reduced headache days per month by as much as 50% in patients experiencing multiple migraine days each month. these new biologics, however, are more expensive for the patient compared with other prophylactic treatments the rational of this study was to assess the efficacy of erenumab on frequency of monthly migraine days in adults at baseline, 3 months and 6 months, disability in patients with chronic migraine and on post covid migraine severity

Eligibility criteria:
inclusion criteria: * -ages eligible for study: 18 years to 65 years (adult, older adult) * sexes eligible for study: all * history of at least 5 attacks of migraine -≥ 15 headache days of which ≥ 8 headache days meet criteria as migraine days during the baseline period * chronic migraineurs with failure to more than 2 preventive treatments * chronic migraineurs without any preventive treatments * naive to anti cgrp monclonal antibodies exclusion criteria: * participants are excluded from the study if any of the following criteria apply: • unable to understand the study requirements, the informed consent, or complete headache records as required per protocol; * history of cluster or hemiplegic headache * evidence of seizure or major psychiatric disorder cardiac or active hepatic disease * pregnant, actively trying to become pregnant, or breast-feeding; * episodic migraineurs, * other headache types * allergy to latex; * received nerve blocks or trigger point injections in the previous 8 weeks or plans to receive them during the study; * prior exposure in the last 6 months to biologics or drugs specifically targeting the calcitonin gene-related peptide (cgrp) pathway; * a psychiatric condition, that may affect the interpretation of efficacy and safety data or contraindicates the participant's participation in the study

Keywords: migraine, erenumab,
ceftobiprole in hospital acquired pneumonia

Conditions: Pneumonia

Summary: the purpose of this study is to compare the clinical cure rate of ceftobiprole medocaril (the water-soluble prodrug \[form\] of ceftobiprole) referred to as ceftobiprole versus a comparator in the treatment of patients with nosocomial pneumonia.

ceftobiprole medocaril (the water-soluble prodrug \[form\] of ceftobiprole) referred to as ceftobiprole is a cephalosporin antibiotic with anti-mrsa (methicillin-resistant staphylococcus aureus) activity. ceftobiprole is not yet approved for the treatment of nosocomial (hospital-acquired) pneumonia. this is a randomized, double-blind, multicenter study of ceftobiprole versus a comparator (linezolid plus ceftazidime) to assess the effectiveness and safety of ceftobiprole in patients with nosocomial pneumonia. the patients will be randomized to ceftobiprole plus placebo or the comparator. the primary endpoint is the clinical cure rate of ceftobiprole at the test-of-cure visit. the patients will receive either ceftobiprole plus placebo or the comparator for 7 to 14 days (unless extended at discretion of medical monitor). patient safety will be monitored throughout the study. in december 2006, this study (bap00248) and another similar study (bap00307, see nct00210964) were amended (changed) to create 1 study (bap00248/307).therefore, the results reported for this study will be combined with the results reported for study bap00248 patients will receive either ceftobiprole plus placebo or a comparator by intravenous infusion for 7 to 14 days (unless extended at discretion of medical monitor).

Eligibility criteria:
inclusion criteria: * patients suffering from nosocomial pneumonia or ventilator-associated pneumonia * female patients must be postmenopausal for at least 1 year, surgically sterile, or practicing an effective method of birth control, before entry and throughout the study, and have a negative serum or urine pregnancy test at the screening exclusion criteria: * known or suspected hypersensitivity to any related antibiotic medications * any known or suspected condition or concurrent treatment that would be contraindicated by the prescribing information * treatment with any investigational drug within 30 days before enrollment * prior enrollment to this study

Keywords: ceftobiprole medocaril nosocomial pneumonia ventilator-associated pneumonia cephalosporins methicillin-resistant staphylococcus aureus