Kornimate/medical-research-clean huggingface dataset:
a phase ii study of total neoadjuvant therapy for locally advanced gastric cancer

Conditions: Gastric Cancer; Neoadjuvant Therapy

Summary: this prospective, single arm phase ii study is designed to evaluate the rate of pathologic complete response of neoadjuvant chemoradiotherapy and neoadjuvant chemotherapy followed by surgery for locally advanced gastric adenocarcinoma


Eligibility criteria:
inclusion criteria: * histologically or cytologically proven locally advanced gastric adenocarcinoma in patients staged as ct3-4n+m0 * no distant metastasis in liver,lung,bone,central nervous system(cns),no peritoneal transplantation * no prior abdominal or pelvic radiotherapy * karnofsky performance status(kps)≥ 70, predictive life span no less than 6 months * patients must have normal organ and marrow function as defined below: leukocytes: greater than or equal to 3,000 g/l; platelets: greater than or equal to 100,000/mm3 .hemoglobin:greater than or equal to 10g/l .total bilirubin: within normal institutional limits; ast/alt: less than or equal to 1.5 times the upper limit; creatinine within normal upper limits * informed consent exclusion criteria: * any prior chemotherapy or other cancer treatment prior to this protocol * patients with other cancer history except cervical carcinoma in situ and non-malignant melanoma skin cancer * with any distant metastasis in liver,lung,bone,cns,or peritoneal transplantation * history of allergic reactions attributed to similar chemical or biologic complex to s-1 or xeloda or oxaliplatin * uncontrolled illness including, but not limited to, active infection, symptomatic heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness * history of myocardial infarction within the past 6 months or history of ventricular arrhythmia * history of prior radiation to the abdomen * pregnant or lactating females

Keywords: gastric cancer neoadjuvant chemoradiotherapy neoadjuvant chemotherapy
remote ischemic preconditioning as a method against subclinical renal injury and contrast-induced nephropathy

Conditions: Atherosclerosis; Stable Angina; Peripheral Artery Disease; Contrast-induced Nephropathy

Summary: contrast-induced nephropathy (cin) has remained significant and severe complication of angiographic procedures despite the increasing use of preventative methods. it has been associated with prolonged hospital stay, high morality and the need for dialysis. since classically used creatinine for diagnosing of cin does not reflect the degree of tubular injury before 24-48 hours after exposure to contrast media alternative earlier biomarkers and preventative methods are needed. remote ischemic preconditioning is a non-invasive and safe method which in some studies has been reported to protect against contrast-induced nephropathy. the purpose of this study is to evaluate the effect of remote ischemic preconditioning (ripc) (1) as an additional method to standard treatment to prevent subclinical and clinical contrast-induced acute kidney injury and (2) to assess its effect on functional properties of arterial wall, organ damage biomarkers and low molecular weight metabolites.


Eligibility criteria:
inclusion criteria: * age greater than 18 years, no upper age limit * patients with stable coronary artery disease (ii - iii class according to the canadian cardiovascular society) hospitalized for coronarography or with lower extremity arterial disease hospitalized for angiography * written informed consent exclusion criteria: * pregnancy * age less than 18 years * egfr \< 30 ml/min/1,73 m2 * simultaneous participation in an other clinical trial * coexisting pathology of the upper-limbs limiting the use of the cuff (bilateral amputee, recent trauma, chronic ulcers, significant upper limb peripheral atherosclerosis (radial pulse not palpable on either side)) * malignant tumor (in remission less than 5 years or ongoing treatment) * documented allergic reaction to iodinated contrast agent * acute infection (body temperature 38 degrees celsius or higher, c reactive protein 50mg/l or higher) * cardiac rhythm abnormalities (atrial fibrillation, frequent supraventricular premature complexes) * documented myocardial infarction within 30 days * inability to understand the instructions of the study * vascular surgery in axillary region * unable to lie supine for 40 minutes * home oxygen treatment * documented upper limb deep vein thrombosis

Keywords: remote ischemic preconditioning contrast-induced nephropathy stable coronary artery disease lower extremity arterial disease low molecular weight metabolites functional properties of arteries
safety/efficacy study of subcutaneously injected prandial insulins compared to insulin lispro alone in patients with type 2 diabetes mellitus

Conditions: Diabetes Mellitus, Type II

Summary: the purpose of the study was to compare humalog (insulin lispro)-recombinant human hyaluronidase ph20 (rhuph20) or novolog (insulin aspart)-rhuph20 to insulin lispro for the treatment of type 2 diabetes mellitus (t2dm) in basal-bolus therapy.

criteria for randomization into the study included 1) fasting blood glucose and pre-dinner glucose values in the range of 70 to 140 milligrams per deciliter (mg/dl) approximately 60% of the time for 7 days prior to randomization; 2) 90 minute or 2-hour postprandial blood glucose \<220 mg/dl approximately 70% of the time for 7 days prior to randomization; and 3) successfully completing 3 days of 10-point glucose monitoring and have at least 4 self-monitored blood glucose values on all non-10-point monitoring days. participants that did not meet 1 or more of these criteria during a 4- to 6-week titration period were not randomized.

Eligibility criteria:
inclusion criteria: * males or females ≥18 years * type 2 diabetes mellitus (t2dm) treated with insulin ≥12 months and prandial insulin (at least 2 meals per day) for ≥2 months * body mass index (bmi) of 23.0 to 45.0 kilograms per meter squared (kg/m\^2) * glycosylated hemoglobin (hba1c) level 7.0 to 8.5%, inclusive * fasting c-peptide \<0.6 nanograms per milliliter (ng/ml) * willingness to use insulin glargine twice a day as basal insulin for the duration of the study * willingness to avoid use of an insulin infusion pump or unblinded continuous glucose monitoring (cgm) during the study exclusion criteria: * known or suspected allergy to any component of any of the study drugs * exclusive use of pre-mixed insulins * use of pramlintide, exenatide, and/or liraglutide within 30 days of screening * use of sulfonylureas within two months of screening * use of drugs (such as corticosteroids or antimetabolites) that could interfere with the interpretation of study results or are known to cause clinically relevant interference with insulin action, glucose utilization, or recovery from hypoglycemia, during the study or within 30 days of screening * recurrent severe hypoglycemia (more than 2 episodes over the last 6 months) or hypoglycemic unawareness, as judged by the investigator

Keywords: type 2 diabetes
a study to evaluate the long-term safety and tolerability of gk activator (2) in patients with type 2 diabetes.

Conditions: Diabetes Mellitus Type 2

Summary: this study will evaluate the long-term safety and tolerability of gk activator (2) at doses ranging from 25mg - 100mg po bid, administered alone or in combination with metformin, in patients with type 2 diabetes. eligible patients will be those who have completed study bm18248 (gk activator (2) monotherapy) or bm18249 (gk activator (2) and metformin); they will continue on the same treatment regimen (mono or combination therapy) as they received in the initial study. the anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.


Eligibility criteria:
inclusion criteria: * type 2 diabetic patients who have completed studies bm18248 or bm18249; * patients considered by the investigator to be suitable for long term treatment with gk activator (2). exclusion criteria: * type 1 diabetes mellitus; * women who are pregnant, breast-feeding or not using adequate contraceptive methods.
safety of intramuscular injection of allogeneic plx-pad cells for the treatment of critical limb ischemia

Conditions: Peripheral Artery Disease; Peripheral Vascular Disease; Critical Limb Ischemia

Summary: the the purpose of this study is to determine the safety of plx-pad single dose, intra-muscular injection for the treatment of cli patients.

plx-pad are mesenchymal-like stromal cells derived from a full term placenta, termed plx-pad, and intended for the treatment of critical limb ischemia

Eligibility criteria:
inclusion criteria: 1. diagnosis of critical limb ischemia defined as persistent, recurring ischemic rest pain for at least two (2) weeks, and/or ulceration or gangrene of the foot or toe, with abi \< 0.4 or/and tbi \< 0.4 or transcutaneous partial pressure of oxygen ≤ 30 mmhg po2 at the foot. 2. rutherford category 4-5 3. no acceptable options for re-vascularisation as confirmed by angiographic imaging results or by color flow duplex ultrasound obtained within 6 months prior screening visit and signed approval of vascular surgeon. 4. in the opinion of the investigator, major amputation is not anticipated over a period of three (3) months. exclusion criteria: 1. uncontrolled hypertension (defined as diastolic blood pressure \> 110 mmhg or systolic blood pressure \> 180 mmhg during screening). 2. poorly controlled diabetes mellitus (hba1c \> 9%) 3. wounds with severity greater than grade 2 on the wagner scale 4. life-threatening ventricular arrhythmia - except if an icd is implanted - or unstable angina pectoris - characterized by increasingly frequent episodes with modest exertion or at rest, worsening severity, and prolonged 5. st segment elevation myocardial infarction and/or tia/cva within six (6) months prior to enrollment. patients with severe congestive heart failure (i.e. nyha stage iv) 6. in the opinion of the investigator, the patient is unsuitable for cellular therapy.

Keywords: peripheral artery disease peripheral vascular disease critical limb ischemia
study of the efficacy and safety of amt-101 in subjects with ulcerative colitis (lombard)

Conditions: Ulcerative Colitis

Summary: randomized, placebo-controlled, double-blind, parallel-group, multicenter, phase 2a study of the efficacy and safety of oral amt-101 in subjects with moderate to severe ulcerative colitis.

this is a randomized, placebo-controlled, double-blind, parallel-group, multicenter, phase 2a study to evaluate the efficacy and safety of oral amt-101 in subjects with moderate to severe ulcerative colitis.

Eligibility criteria:
inclusion criteria: * male and female subjects aged 18 to 75 years, inclusive. * diagnosis of moderate to severe uc. * women of childbearing potential (wocbp) must have a negative pregnancy test at screening and at the randomization visit. * able to participate fully in all aspects of this clinical trial. * written informed consent must be obtained and documented. exclusion criteria: * known gastrologic, or systemic condition that may compromise severity or diagnosis of disease. * history or current evidence of colonic or abdominal abnormalities. * prohibited therapies or procedures before the screening period as specified per protocol. * a concurrent clinically significant, serious, unstable, or uncontrolled underlying cardiovascular, pulmonary, hepatic, renal, gastrointestinal, genitourinary, hematological, coagulation, immunological, endocrine/metabolic, or other medical disorder that, in the opinion of the investigator, might confound the study results, pose additional risk to the subject, or interfere with the subject's ability to participate fully in the study. * pregnant or lactating females. * current or recent history of alcohol dependence, illicit drug use, mental or legal incapacitation, or a history of clinically significant psychiatric disorders that, in the opinion of the investigator, may interfere with the subject's ability to comply with the study procedures. * unable to attend study visits or comply with procedures. * previous exposure to amt-101 or similar and known hypersensitivity to amt-101 or its excipients.

Keywords: inflammatory bowel diseases
screening of niemann-pick disease, type c in a psychiatric population

Conditions: Psychiatric Adults Patients

Summary: niemann-pick disease, type c is a rare genetic disorder characterized by a failing in intracellular cholesterol transport, inducing an accumulation of sphingolipids in the brain. neurological signs are at the forefront of the disease. there are also psychiatric signs of psychotic kind among 28 to 45 % of patients according to studies, and a thirty cases were published. these signs can be concomitant with neurological signs or precede them. is is likely that psychotic disorders are the first signs of a niemann-pick disease not yet non encore diagnosed for some patients. yet, no prevalence study for this disease in a psychiatric population of patients currently exists. in response to this problem this study proposes to search patients whose disease could be of organic origin or patients whose disease is suspected, based on clinical data. the diagnosis will be confirmed certified with a genetic and/or biochemical test.

the aim of this study is to search among a population psychotic adult patients, the ones that present a type c niemann-pick disease in order to to estimate the prevalence.

Eligibility criteria:
inclusion criteria: * hallucinations visual * confusion * catatonia * significant fluctuation of symptoms * unusual or paradoxical reaction to the treatment * progressive cognitive deterioration exclusion criteria: * patients under 18 years * patients unable to give their free consent and without a legal representative * breastfeeding or pregnant women

Keywords: niemann-pick disease, type c psychiatric psychotic disorders
medial peel release technique tka randomized clinical trial

Conditions: Total Knee Arthroplasty; Osteoarthritis, Knee

Summary: medial subperiosteal release is a commonly performed technique to improve surgical exposure and aid in joint balancing. this is a routine step during primary total knee arthroplasty that will be conducted on every enrolled patient. this is commonly performed both via scalpel (aka sharp medial peel) or electrocautery. the intervention will be randomly assigning subjects undergoing tka into two groups, one receiving subperiosteal release using a scalpel (aka sharp medial peel) and the other via electrocautery.

medial release is a commonly performed technique to improve surgical exposure and aid in joint balancing. it is thought to be linked to the postoperative incidence of pes bursitis. however, the effect of scalpel vs electrocautery techniques for subperiosteal release has not been examined for their potential effect on the rates of pes bursitis. this randomized clinical trial will assign patients undergoing tka for osteoarthritis (oa) into either scalpel or electrocautery release groups for their operation and will be followed postoperatively at 3 weeks and 3,6, and 12 months in order to determine the effect of release technique on rates of pes bursitis. this study will take place at emory orthopaedics. subjects will not be compensated. patients presenting to the clinic for evaluation of tka will be screened for their eligibility in this study and recruited as well as consented in the clinic. this study can advance current clinical knowledge by evaluating two common surgical techniques to determine which may lead to better outcomes for patients undergoing tka, a common orthopedic procedure, and reduce dissatisfaction as well as pain following operation.

Eligibility criteria:
inclusion criteria: * patients over age 18 * patients undergoing primary tka for osteoarthritis exclusion criteria: * patients undergoing revision tka * any patients not undergoing tka for non-oa diagnosis * adults unable to consent * pregnant women * prisoners

Keywords: medial subperiosteal release
treat arterial hypertension and diabetes in rural africa

Conditions: Diabetes; Arterial Hypertension

Summary: the purpose of this study is to determine the efficacy of three different interventions to improve treatment adherence among patients with arterial hypertension or diabetes in rural cameroon.

non communicable chronic diseases such as arterial hypertension (ah) and diabetes (dm) are a great burden for public health in cameroon. however, outside the main cities access to appropriate diagnosis and treatment of these health-conditions is still very poor. the swiss ngo "fondation coopération afrique" started in 2007 a program to integrate chronic disease management with focus on ah and dm into the primary health care system of peripheral non-physician health facilities in a rural area of central cameroon. a first evaluation after one year revealed very low treatment adherence among the newly diagnosed patients as the main challenge. in order to improve patient's adherence we expose them randomly to one of three interventions: the first intervention consists in a written agreement on long-lasting therapy (treatment contract). patients get information about the importance of a regular long term treatment and personal engagement to follow treatment and clinical controls regularly. the second intervention introduces in addition to the treatment contract a reminder system. in case of follow-up failure a community worker traces the patient to recall the visit at the health centre. the third intervention consists of the treatment contract combined with a financial incentive in form of one month free treatment after four months of regular follow-up. we allocated randomly one of the three interventions to each health center.

Eligibility criteria:
inclusion criteria: * patients with newly diagnosed arterial hypertension or non insulin dependent diabetes type 2 which require treatment and can be treated in the health centre * informed consent by the patient exclusion criteria: * patient already under treatment * patients who need to be referred to a hospital * no informed consent by the patient

Keywords: primary health care in rural africa chronic non-communicable diseases patient compliance treatment adherence
improvement of fear-avoidance beliefs in patients with chronic low back pain

Conditions: Non Specific Low Back Pain

Summary: non-specific chronic low back pain is the main cause of public spending on health care and labor, with a prevalence of 10.2%. its therapeutic management is difficult, with moderate levels of pain and persistent disability over time, influenced by psychosocial factors, such as "fear-avoidance" beliefs. the supervised therapeutic exercise program associated with an educational component is one of the most effective interventions to reduce pain and disability in these patients, but its efficacy seems to be less if there are erroneous beliefs, avoidance attitudes, or fear of physical activity, since it makes it difficult to follow the recommendations. the back school would address this problem, seeking to improve pain, disability and increase quality of life.

the main objective of this study is to evaluate the influence of the intervention of the back school of the hospital universitario insular de gran canaria in reducing the levels of "fear-avoidance" beliefs in patients with non-specific chronic low back pain.

Eligibility criteria:
inclusion criteria: * diagnosis of non-specific low back pain, age 18-65 years, acceptance of voluntary participation and signature of the informed consent document. * acceptance of voluntary participation and signature of the informed consent document. * sufficient oral and written knowledge of the spanish language * absence of any other educational intervention at the present time. exclusion criteria: * presence or suspicion of red flags * cognitive impairment * spinal surgery * intolerance to physical activity * litigation pending resolution * pregnancy or postpartum less than 6 months * withdrawal from the study (signature of the informed consent revocation document).

Keywords: pain school health promotion medical education exercise
the effects of pre-operative anxiety on anesthetic recovery and post-operative pain in donor nephrectomy

Conditions: Kidney Transplantation; Anxiety; Pain, Acute; Anesthesia Recovery Period

Summary: kidney transplant is the most effective choice of treatment for patients with end-stage kidney failure in terms of quality of life and longevity. today, 20-25% of kidney transplantations are implemented with living donors. donor nephrectomy is an operations which has the end goal of a living donor donating one of his kidneys to a patient with end-stage kidney failure (1). pre-operative anxiety is a condition which is characterized by a random illness, being hospitalised, anesthesia, surgery, or uneasiness or anxiety stemming from not knowing what is to be experienced. educating and informing in the pre-operative period is the first step in mentally preparing the patient for the operation. in some studies, it has been pointed out that patients who were thoroughly informed in the pre-operative period have lower anxiety levels both in the pre-operative and post-operative periods with also less levels of pain and increased recovery rates in the latter (2). anesthetic recovery starts at the end of the surgical process and ends with the anesthetized patient completely regaining a wide-awake, responsive state, defensive reflex, and muscle strength. post-operative pain is acute pain which starts with surgical trauma and ends with tissue healing (3). providing optimal post-operative analgesia plays an important role in the prevention of post-operative complications (1,4,5). there are studies which examine the link between pre-operative anxiety and post-operative pain (59,74,74,77,78). patients who will undergo a donor nephrectomy constitute a specific group of patients both because they are not operated due to a health problem that they have and because the operation results with them losing an organ. there are no prospective studies about the effects of pre-operative anxiety on anesthetic recovery and post-operative pain in individuals who have undergone donor nephrectomy in literature. because of this, we have aimed to research prospectively the effects of pre-operative anxiety on anesthetic recovery and post-operative pain in patients that were to undergo donor nephrectomy surgery.


Eligibility criteria:
inclusion criteria: * asa i-ii between 18-60 years * donor nephrectomy patients exclusion criteria: * psychiatric disturbance * medicinal allergy