Kornimate/medical-research-clean huggingface dataset:
a pilot study of neoadjuvant chemotherapy with or without camrelizumab for locally advanced gastric cancer

Conditions: Gastric Cancer

Summary: it is a single-center, open-lable, randomized controlled trial to prospectively investigate the effectiveness and safety of camrelizumab combined with dos regimen chemotherapy in neoadjuvant treatment of patients with locally advanced gastric cancer.


Eligibility criteria:
inclusion criteria: 1. subjects voluntarily join the study and sign an informed consent form, have good compliance and cooperate with follow-up; 2. male or female patients between the ages of 18-75; 3. patients diagnosed as gastric adenocarcinoma by histology or cytology; 4. stage: locally advanced stage (t3-4an1-3m0); 5. have not received other immunotherapy drugs or chemotherapy drugs in the past; 6. ecog (eastern us cooperative oncology group) score: 0-1 points; 7. has sufficient organ and bone marrow function exclusion criteria: 1. other malignant tumors that have appeared or are currently suffering from within 5 years, except for cured cervical carcinoma in situ, non-melanoma skin cancer and superficial bladder tumors \[ta (non-invasive tumor), tis (carcinoma in situ) ) and t1 (tumor infiltration basement membrane)\]; 2. a distant metastasis occurs; 3. those who have multiple factors that affect oral medications (such as inability to swallow, chronic diarrhea, etc.); 4. accompanied by pleural effusion or ascites, causing respiratory syndrome (nci-ctc ae v5.0 grade ≥ 2 dyspnea); 5. patients with any severe and/or uncontrollable disease； 6. patients with gastrointestinal diseases with bleeding tendency (such as active gastrointestinal ulcers) or patients determined by the researcher to cause gastrointestinal bleeding, perforation or obstruction 7. patients whose imaging shows that the tumor has invaded the tissues around important blood vessels or the investigator judges that the tumor is likely to invade important blood vessels and cause fatal bleeding during the follow-up study; 8. received glucocorticosteroid or immunosuppressive therapy within 7 days before grouping; 9. regardless of the severity, patients with any signs of bleeding or medical history; within 4 weeks before grouping, patients with any bleeding or bleeding events nci-ctc ae v5.0 grade ≥ 3, unhealed wounds, ulcers or fracture 10. those who have had arterial/venous thrombotic events within 6 months, such as cerebrovascular accidents (including temporary ischemic attacks), deep vein thrombosis and pulmonary embolism; 11. people with a history of psychotropic drug abuse and unable to quit or have mental disorders; 12. participated in other anti-tumor drug clinical trials within four weeks; 13. according to the judgment of the investigator, those with concomitant diseases that seriously endanger the safety of the patient or affect the completion of the study; 14. female patients who are pregnant or breastfeeding; 15. known hypersensitivity to any study drug.

Keywords: gastric cancer neoadjuvant chemotherapy immunotherapy
a phase ii study of kct-0809 in patients with dry eye syndrome

Conditions: Dry Eye Syndromes

Summary: to evaluate the efficacy and safety of kct-0809 compared to placebo in patients with dry eye syndrome.


Eligibility criteria:
inclusion criteria: * corneal and conjunctival damage * insufficiency of lacrimal secretion * ocular symptom exclusion criteria: * severe ophthalmic disorder * punctual plugs or surgery for occlusion of the lacrimal puncta

Keywords: dry eye syndromes corneal diseases conjunctival diseases
connected pens for diabetes study

Conditions: Diabetes Mellitus

Summary: the objective of the study is to evaluate the impact of a wireless smart insulin pen and smartphone-based bolus advisor on clinical and psychosocial outcomes in insulin-treated diabetes mellitus patients after 3 months of use.

the study is a prospective, randomized, controlled treatment design. the study device will be used for multiple daily injection (mdi) therapy of insulin. the participant will interact with the study device in the uncontrolled environment of the participant's daily life. the study protocol is designed to yield meaningful data to determine clinical and psychosocial benefits of using the study device. the study will evaluate the study device as an intervention versus a control group.

Eligibility criteria:
inclusion criteria: 1. the participant is ≥ 18 years of age 2. the participant has type 1 or type 2 diabetes and is being treated with intensive insulin therapy via injection for ≥ 3 months. intensive insulin therapy is defined as at least one long acting insulin dose and two or more short acting insulin doses per day. 3. glycated hemoglobin (hba1c) ≥ 7.5%). 4. the participant is a current iphone user for over 30 days. 5. participant adjusts meal insulin doses based on carbohydrate content of meals. 6. the participant is fluent in the english language. 7. the participant and the investigator understand participant obligations and agree that the participant is willing and able to complete the study visits. 8. patients prandial insulin need must be \<30 u per meal. exclusion criteria: 1. the participant has been using unblinded cgm for less than 6 months. 2. the participant uses pre-mixed insulin. 3. current use of a smart insulin pen. 4. use of sliding scale insulin therapy that determines insulin dosages based exclusively on specific blood glucose results 5. used systemic oral or inhaled steroids for more than 7 days within the last 3 months 6. oral anti-diabetic agents, with the exception of metformin 7. injectable anti-diabetic agents other than insulin 8. the participant is legally blind or has below specified best-corrected vision level. 9. diagnosed with any clinically significant infectious disease or major organ system disease, such as gastroparesis or renal disease (at investigator's discretion) 10. the participant is pregnant, lactating, or plans to become pregnant in the next 6 months. 11. the participant is currently participating in another clinical study that may preclude the participant from meeting the obligations of this study. 12. the participant has any additional condition(s) (medical, social, or psychosocial) that in the investigator's opinion would warrant exclusion from the study or prevent the participant from completing or complying with the study requirements.
association between schizophrenia and cancer

Conditions: Schizophrenia; Cancer

Summary: a family study of the negative association betweeen schizophrenia and cancer


Eligibility criteria:
inclusion criteria: * schizophrenia
study to compare the efficacy and safety of micafungin versus conventional amphotericin b for the treatment of neonatal candidiasis

Conditions: Candidiasis

Summary: the study will evaluate how effective and how safe the drug micafungin is when compared to the drug amphotericin b deoxycholate in treating neonates and young infants with certain fungal infections.

neonates and young infants will be stratified by estimated gestational age and by world region

Eligibility criteria:
inclusion criteria: * infant greater than 48 hours of life after birth up to day of life 120 at the time of culture acquisition * diagnosis of proven invasive candidiasis within 4 days prior to study start * subject's parent or legal guardian agrees not to allow subject to participate in another study with another investigational drug while on treatment. exclusion criteria: * infant with any history of a hypersensitivity or severe vasomotor reaction to any echinocandin or systemic amphotericin b product * infant who has received more than 48 hours of systemic antifungal therapy prior to the first dose of study drug * infant who has a breakthrough systemic fungal infection while receiving amphotericin b product or an echinocandin as prophylaxis * infant who has failed prior systemic antifungal therapy for this episode of invasive candidiasis * infant who is co-infected with a non-candida fungal organism * infant whose positive yeast cultures are solely from an indwelling bladder catheter (unless obtained at the time the indwelling catheter was placed) or sputum. * infant previously enrolled in this study

Keywords: candidiasis candida neonate candidemia micafungin mycamine amphotericin b deoxycholate
innovative approaches to tuberculosis control

Conditions: Tuberculosis

Summary: this study is designed as a cluster-randomized trial. the cluster unit is at the community level. communities will be randomized to 1 of 2 study arms: dots+acf or dots. communities in the dots+acf arm will receive door-to-door symptom screening of the entire population by health care workers between 2 and 4 times over a 9-month period. those communities in the dots-arm will receive the current standard of care in those communities (pcf). all study communities will be receiving between 4 and 6 visits by community health workers annually as part of a program to assess and follow-up illnesses in each household. households with ill residents will be visited more often. the intervention for this study is simply adding 3 to 5 simple questions to the current protocol. for subjects responding positively to these questions, results will be returned to the subject at their home and routine, standard of care follow-up diagnostic and treatment algorithms will be followed.

despite free arv drugs and free tb treatment, and an expanding dots program, tb rates have not diminished in this city overall (29), suggesting that dots alone will not be sufficient to turn the tide. nevertheless, an elemental acf strategy did appear to work well in this city. a prior international collaborations in infectious disease research (icidr), in one area of rio de janeiro, evaluated the use of the who's directly observed therapy, short course (dots) strategy versus an enhanced dots strategy (dots-a), which included household contact investigation as a means of identifying cases. a statistically significant reduction in incidence rates between dots versus dots-a communities was seen from 2000 to 2002 (figure 2), suggesting that acf strategies can be instrumental in reducing incidence rates if subjects are detected and treated. treatment completion rates among new tb cases were not significantly different statistically in the 2 study arms, however treatment completion rates overall increased from 68% to 77% over the course of the study. overall, the dots communities exhibited little change (+7%) in tb incidence over the 5-year period, while dots-a communities showed a combined decrease (-14%) (p\<0.05). the difference suggests that a large scale acf campaign at a more intensive level (ie, door-to-door case finding) could have a significant impact on long-term tb incidence in a community.

Eligibility criteria:
inclusion criteria: * all residents of the study communities will be eligible to be surveyed at their homes, regardless of gender, age, or ethnicity.
can pre-operative flexible 3d models of pulmonary malformations facilitate thoracoscopic resection

Conditions: Pulmonary Malformation

Summary: the national rare diseases plans, the ongoing malfpulm phrc and thoracoscopic advents in children, are remarkable improvements in understanding and managing lung malformations. the resection of these malformations is now proposed in most cases to avoid infections which are difficult to treat and to diagnose or to avoid exceptional tumors. procedures are ideally performed around the age of 5-6 months to take advantage of the lung growth that continues during the first two years of life. the surgical strategies depend of the malformation size, the tumor risk and surgeon choice: conservative surgery with removal of part of the lobe may be preferred over complete resection of the concerned lobe. if possible, thoracoscopic resection is carried out. the open thoracotomy is more painful and leads to complications such as thoracic deformities, larger scars, blood loss. however, in infants the thoracoscopic work space is small, lung exclusion is challenging and the anatomy (normal or malformative) is difficult to understand in space. the rate of thoracoscopy without conversion to thoracotomy ranges from 98% in one american center with a more radical approach , to 48% in a national cohort. pulmonary exclusion failure, complexity and size of malformations and intra-operative complications are factors of conversion to thoracotomy . these factors can lead surgeons to perform thoracotomy without attempting thoracoscopy. 3d printing is a thriving research field for its educational or therapeutic potential optimization of management, prosthesis, and organ replacement. 3d printing is particularly adapted to pediatrics, which suffers from the rarity of its pathologies and a large spectrum of size and morphology prohibiting the mass production of models. 3d printing models of complex pulmonary pathologies will allowed for a better anesthetic and surgical approach. the modeling of bronchial, vascular and even parenchymatous anatomy permits a better understanding of the anatomical particularities of each patient. this, in turn, avoids the intra-operative conversions to thoracotomy with a direct benefit for the patient.


Eligibility criteria:
inclusion criteria: * patients aged from 1 day to 24 months. * patients with pulmonary malformation eligible for surgery * parents agreement for surgical treatment * parents able to sign an informed consent form * patient benefiting from a social insurance system or a similar system exclusion criteria: * emergency surgeries (less than 15 days between scanner and surgery) * obvious extrapulmonary sequestration on tomographic scanning images * patients with other major malformation additionally to pulmonary malformation * parents unable to understand the purpose of the trial * patient already participating to another clinical trial that might jeopardize the current trial

Keywords: pulmonary malformation 3d printed models thoracotomy thoracoscopy children
non-inferiority of lower dose calcium supplementation during pregnancy

Conditions: Pregnancy Related

Summary: the world health organization currently recommends that pregnant women in populations with low calcium intake receive daily calcium supplementation (1500 - 2000 mg) divided into three doses which are preferably taken at mealtimes, in addition to daily iron folic-acid supplements. despite proven efficacy and the who recommendation, calcium supplementation in pregnancy is not standard of care in the vast majority of low-income and middle-income countries. two important barriers to implementation are the cost of the supplements and complexity of the suggested calcium dosing schedule. a lower dose of calcium (500 mg) administered as a single dose has been shown to be beneficial in several trials, and if found to be as effective as the 1500 mg supplementation regimen, it may help overcome these barriers and increase individual and health system adoption. the investigators will conduct two parallel, individually randomized, double blind non-inferiority trials in india and tanzania. participating pregnant woman will be randomized to either 1500 mg or 500 mg calcium supplementation. the india and tanzania trials are independently powered for the primary outcomes of i) preeclampsia and ii) preterm birth. the india and tanzania sites will each enroll 11,000 participants.


Eligibility criteria:
inclusion criteria: * nulliparous * attending first anc visit at study clinics * pregnant women \<20 weeks * ≥ 18 years old * intending to stay in study area until 6 weeks post delivery * provides informed consent exclusion criteria: * history or signs and/or symptoms of nephrolithiasis * prior diagnosis of parathyroid disorder or thyroidectomy * diseases that require digoxin, phenytoin, or tetracycline therapy
evaluation of staff covid-19 wellbeing centres in a healthcare workplace: covid-well study

Conditions: Mental Health Wellness 1

Summary: evaluation of a workplace intervention to implement supported wellbeing centres in a healthcare workplace during and after the covid-19 pandemic. mixed-methods evaluation study - including collection of service use monitoring data, online survey and qualitative interviews.

project aims: 1. to describe the cost, reach and usage of the staff wellbeing centres 2. to gather insight into experiences of those who access the facility ('service users') as well as those of support workers ('wellbeing buddies'). 3. to identify any facilitators, obstacles or barriers to accessing the facility. 4. to identify perceptions of facility users and non-users towards the value of the facilities during and after the coronavirus pandemic. 5. to establish recommendations for longer-term sustainability of the wellbeing centres. interviews will be conducted with up to 45 interview participants (10-15 wellbeing buddies, 25-30 staff). online survey will be conducted - all nottingham university hospitals national health service (nhs) staff invited to take part (\>14,000). the survey will include measures of mental wellbeing (warwick-edinburgh wellbeing scale, 14-item - license received), and single items measures of job stressfulness, job satisfaction, presenteeism, turnover intentions and work engagement.

Eligibility criteria:
inclusion criteria: * national health service staff which includes employees, volunteers or healthcare students, as well as bank staff (all have access to the staff wellbeing centres). * ability to give informed consent. for survey element: ability to access the internet (to complete the online survey) for interview element: ability to attend an individual interview. exclusion criteria: • inability to communicate in spoken english.
efficacy of olmesartan on cerebral glucose metabolism, vascular inflammation and adipose tissue

Conditions: Efficacy of Olmesartan on Cerebral Glucose Metabolism in Essential Hypertension

Summary: hypertension is a leading risk factor for morbidity and mortality worldwide. the brain is a major target of the damaging effects of hypertension. hypertension has been recognized as the leading cause of dementia as well as the most important risk factor for stroke and vascular cognitive impairment. although glucose is the principal cerebral energy source, impact of hypertensive treatment on cerebral glucose metabolism is poorly understood.


Eligibility criteria:
inclusion criteria: * written informed consent obtained * male and female subjects aged 20 years or older at informed consent * essential hypertension who had never received angiotensin ii receptor antagonists and calcium channel blockers exclusion criteria: * secondary hypertension or malignant hypertension * diabetes mellitus * history or evidence of a stroke * hepatic or hematologic abnormality * mild cognitive impairment or dementia * serum potassium level ≥ 5.5 meq/l * serum creatinine level ≥ 3.0 mg/dl * acute or chronic disease * allergy to any drugs * pregnancy
study in prostaglandin associated peri-orbitopathy switching from prostaglandin monotherapy to omidenepag isopropyl

Conditions: Normal Tension Glaucoma; Primary Open-angle Glaucoma; Glaucoma, Suspect; Ocular Hypertension

Summary: this study is for patients have been using prostaglandin analogue eye drops with a preservative for 3 months or more and have been diagnosed with prostaglandin-associated peri-orbital disease. the investigators would like to confirm the real world evidence(rwe) of safety and efficacy after changing to eybelis ophthalmic solution 0.002%.

this clinical trial is a single-arm, multicenter, prospective clinical trial, in which participants have consented to participate in the clinical trial are sequentially registered and proceeded. the participant's participation period is a total of 24 weeks after the 4-week wash-out period, and according to the visit schedule, tests according to medical procedures are conducted at screening, baseline, 6, 12, 18, and 24 weeks to collect data on safety and effectiveness.

Eligibility criteria:
inclusion criteria: 1. adults between 19 and 79 years of age. 2. normal tension glaucoma, primary open-angle glaucoma, glaucoma suspect and ocular hypertension patients. 3. patients who have received prostaglandin analogue (pga) eye drops with preservatives for at least 3 months from the date of consent. 4. patients diagnosed with prostaglandin associated peri-orbitopathy due to the use of prostaglandin analogue (pga) eye drops with preservatives. * dues (deepening of upper eyelid sulcus) * fleb (flattening of lower eyelid bag) * upper eyelid ptosis * periorbital hyperpigmentation * ciliary hypertrichosis 5. those who have agreed in writing to participate in this clinical trial. exclusion criteria: 1. patients with glaucoma caused by secondary causes such as pseudo-exfoliative glaucoma and pigment dispersion syndrome 2. patients with intraocular pressure greater than 34 mmhg 3. patients with severe visual impairment (mean deviation -20db or more) 4. history of eye surgery within 6 months from the date of consent (corneal refractive surgery or intraocular surgery including lasik and lasek that affect the condition of the ocular surface) 5. patients with severe dry eyes (those receiving or in need of drug treatment), those with eye allergies, infections, or inflammatory diseases 6. those who are using systemic or eye steroids (except for topical skin) 7. those who are using eye drops for the treatment of glaucoma other than prostaglandin analogues eye drops with preservatives 8. pregnant or lactating women 9. those with hypersensitivity to anesthetic eye drops, fluorescein, or research drugs 10. those who need to wear contact lenses during the clinical trial period 11. artificial lens eye (pseudophakia) or aphakic eye (aphakia) 12. periocular trauma, surgical history, or thyroid orbitopathy affecting the evaluation of prostaglandin associated peri-orbitopathy 13. other clinical investigators judged to be inappropriate to participate in clinical trials

Keywords: prostaglandin associated peri-orbitopathy(paps)
a real-world study of octreotide microspheres in chinese patients with neuroendocrine tumors

Conditions: Neuroendocrine Tumors

Summary: the aim of this multicenter, open-label, observational study is to evaluate the safety and efficacy of octreotide microspheres in the treatment of advanced neuroendocrine tumors in real clinical practice, especially to evaluate the treatment of octreotide microspheres in various subgroups of neuroendocrine tumor patients.


Eligibility criteria:
inclusion criteria: 1. sign an informed consent form and voluntarily participate in this study; 2. patients with unresectable or metastatic neuroendocrine tumors confirmed by histopathology. patients with recurrence and progression after surgery or local treatment can also be included in the study; 3. age ≥ 18 years old; 4. treatment with octreotide microspheres. exclusion criteria: 1. confirmed pregnant or lactating women; 2. participating in any research with intervention measures outside of routine clinical practice; 3. other situations unsuitable for inclusion in the study determined by the researcher.