Kornimate/medical-research-clean huggingface dataset:
the safety and efficacy of pd-1 monoantrapical chemotherapy in the treatment of local advanced stomach cancer

Conditions: Gastric Cancer

Summary: to explore the safety and efficacy of local advanced stomach cancer patients receiving new complementary treatment of pd-1 monoantiotherapy before surgery


Eligibility criteria:
inclusion criteria: 1. histologically proven adenocarcinoma of the stomach, pd-l1+(cps≥1). 2. clinical ct3-4a/n+m0 disease, confirmed by upper gastrointestinal endoscopy and abdominal computed tomography (ct) and laparoscopy. 3. the gastric tumors are macroscopically resectable by distal gastrectomy with d2 lymph node dissection, and r0 or r1 resection can be achieved. 4. no bulky lymph node metastasis is detected by abdominal ct. 5. no pleural effusion, no ascites exceeding the pelvis and no metastasis to the peritoneum, liver or other distant organs are confirmed by abdominal pelvic ct. 6. no clinically apparent distant metastasis. 7. karnofsky performance status ≥70%. 8. sufficient oral intake. 9. no previous treatment with chemotherapy or radiation therapy for any tumors. 10. no previous surgery for the present disease. 11. sufficient organ function, as evaluated by laboratory tests 7 days or more after the date when the anticancer drugs were given. when patients are recovering from myelosuppression,the revised criteria are shown in parentheses. white blood cell count≥3000/mm3 (2000/mm3) platelet count≥10.0\*104/mm3 (5.0\*104/mm3) aspartate aminotransferase≤100 iu/l alanine aminotransferase≤100 iu/l total bilirubin≤2.0 mg/dl serum creatinine≤1.5 mg/dl 12. no need for emergency surgery due to bleeding or perforation of the primary tumor. 13. no mechanical obstruction. 14. written informed consent. exclusion criteria: 1. past history of upper abdominal surgery. 2. past history of surgery for the gastrointestinal tract. 3. body mass index exceeding 30 kg/m2.
effectiveness of the use of lightback in conventional football training.

Conditions: Injury; Hip

Summary: lightback is a patented device that allows instrumental stretching of the gluteal muscles. football players overload this musculature and this type of device is effective and the cost/benefit ratio is high. the intention is to carry out a randomised clinical trial to carry out a study on athletes to see the differences between a group of football players with their normal training and a group of football players with their normal training and the application of lightback beforehand. the variables studied will be sprint speed in 20 and 40m, vertical jump height, hamstring muscle injuries throughout the season, triceps sural injuries throughout the season, internal and external hip rom, dorsal flexion ankle rom.


Eligibility criteria:
inclusion criteria: * professional football players * age range 18 to 45 years * able to perform physical exertion without discomfort. exclusion criteria: * football players recently injured or in an active recovery phase. * heterometrics * non-collaborators * alteration of sensitivity

Keywords: hip gluteal regions range of motion, articular footballs
development, feasibility and acceptability of an icbt intervention for adolescents with anxiety

Conditions: Anxiety Disorders

Summary: the aim of the feasibility study is twofold: 1) to test the feasibility of the study design, and 2) to test the preliminary efficacy and the acceptability of a new icbt intervention when delivered with different levels of therapist support. the feasibility trial will provide important information on the initial participant responses, and on how to properly collect data in the subsequent rct. the feasibility trial is conducted as a randomized study with 16 participants consisting of two conditions: 1) guided icbt, and 2) on-demand icbt, both to be completed over a 14-week period. participants in the guided icbt condition will receive the new icbt intervention with planned feedback after each completed module. participants in the on-demand icbt condition will receive the intervention with on-demand feedback that is participant-initiated. in both conditions, the therapist may spend a max. of 15 minutes giving feedback per module. as there is no evidence on what amount of therapist support is sufficient for adolescents, the allowed time spent giving feedback will not differ between the two conditions in the feasibility trial. thus, data on engagement will be collected to inform how the two treatment conditions differ. the trial includes data points at pre-treatment (t1) and post-treatment (t2) where the same measures will be administered as are planned in the rct. acceptability of the intervention will be investigated by conducting semi-structured interviews with the participants. the interview will include an evaluation of the intervention, client satisfaction and potential reasons for drop out. the results from the feasibility trial will be used to inform the subsequent rct and to revise the intervention, procedures, and conditions if needed.


Eligibility criteria:
inclusion criteria: * between 12 and 17 years of age * primary anxiety diagnosis * must have the ability to read and write danish * must have internet access * must have a parent able to participate in the treatment alongside the adolescent exclusion criteria: * specific phobia of blood-injection-injury type * an autism spectrum disorder * psychotic symptoms * bipolar disorder * current suicidal ideation or self-mutilating behavior * current alcohol or substance abuse * moderate to severe depression * current eating disorder
estimation of functional liver reserve using cholinesterases

Conditions: Hepatocellular Carcinoma; Cirrhosis; Liver Neoplasm; Liver Disease

Summary: estimation of functional liver reserve in patients with hepatocellular carcinoma (hcc) in cirrhosis is of paramount importance to properly select candidates for surgical resection. together with the value of bilirubin, the presence/absence of ascites and esophageal varices, and the rate of residual liver volume, which are our current parameters to measure functional liver reserve, the investigators sought to investigate the value of preoperative cholinesterases (che) in predict postoperative adverse outcome after hepatic resection for hcc.


Eligibility criteria:
inclusion criteria: 1. total bilirubin \< 2 mg/dl 2. no ascites 3. no esophageal varices, or esophageal varices eradicated by endoscopy 4. liver volume: * residual liver volume \> or = 40% if total bilirubin \< 1 mg/dl * residual liver volume \> or = 50% if total bilirubin between 1 and 1.5 mg/dl * only limited resection if total bilirubin \> 1.5 mg/dl 5. portal vein embolization was selected in any case in whom rlv did not fit the previous requirements. exclusion criteria: 1. total bilirubin \> 2 mg/dl 2. refractory ascites 3. esophageal varices

Keywords: hepatocellular carcinoma liver tumor cirrhosis liver resection tumor staging liver disease staging
study to evaluate the safety, efficacy and pharmacokinetics of optimark (gadoversetamide) in pediatric patients

Conditions: Pathological Processes

Summary: the objective of this study is to characterize the safety, efficacy and pharmacokinetic profiles of optimark at the standard clinical dose of 0.1 mmol/kg in the pediatric patient population.

pediatric patients referred for magnetic resonance imaging (mri) of the liver or central nervous system (cns) will be stratified by age to one of two groups (2 through 11 and 12 through 18 years of age).

Eligibility criteria:
inclusion criteria: * 2 thru 18 years of age * referred for mri of the liver or cns * if female and of child-bearing potential, must have negative pregnancy test within 24 hours of study drug administration * if applicable, agree to use medically accepted method of contraception throughout the study * if necessary, patients entering the pk subgroup must be willing to be housed within the investigational facility for a minimum of 24 hours following drug administration * understand the requirements of the study and provide written consent to participate, agree to abide by the study requirements exclusion criteria: * previously entered into this study or a previous study using optimark * received investigational drug within 30 days of admission into this study or plan to participate in a clinical study prior to the end of this study's monitoring period. (patients on a research protocol using an approved drug ar acceptable) * medical condition, serious intercurrent illness, or extenuating circumstance that would significantly decrease study compliance and all prescribed follow up * known or suspected abnormal renal function for age or requiring dialysis during the study period * pregnant or breastfeeding * scheduled to undergo any contrast-enhanced examination within 7 days prior to baseline examination or during the course of this study period * condition that is a contraindication to mri (i.e., cardiac pacemaker, epicardial pacemaker leads, cochlear implants, ferromagnetic aneurysm clip, ferromagnetic halo device, or other condition that would preclude patient proximity to a strong external magnetic field) * experienced a previous hypersensitivity reaction to a gadolinium-based contrast agent * recent history of hemolytic anemia, sickle cell anemia, or other hemoglobinopathy * undergone a surgical procedure within one week prior to study admission or are planned to undergo a surgical procedure during study participation (central line placement is acceptable) * history of significant claustrophobia * weighs less than 25 lbs (11 kgs)

Keywords: brain, spine, liver, mri, pediatric
outcomes of complicated cl in ethiopia treated with miltefosine

Conditions: Cutaneous Leishmaniases

Summary: cutaneous leishmaniasis in ethiopia causes severe dermatological mutilations. forms that require systemic treatment are clcl, mcl, and dcl. national guidelines recommend equally all drugs that are also used for vl treatment. miltefosine is one of these recommended medications but remains underused due to scarcity of drugs. outcomes of patients receiving miltefosine have never been documented systematically in ethiopia until today. this is needed to provide evidence to advocate for increased access to miltefosine in ethiopia, and to establish baseline data for future research on cl treatment options. the aim of this study is to document treatment outcomes of patients with clcl, mcl, and dcl receiving systemic treatment using miltefosine within a routine care setting located in an endemic area in ethiopia.


Eligibility criteria:
inclusion criteria: * parasitologically or clinically confirmed diagnosis of leishmaniasis * clinical routine care decision to initiate miltefosine exclusion criteria: * medical emergencies, underlying chronic conditions, or other circumstances that make participation in this study medically or otherwise inadvisable
phase i study to evaluate the tolerability of eye drop da-6034 in healthy volunteers

Conditions: Dry Eye Syndrome

Summary: this is a double-blind, randomized, placebo-controlled, 4-period, cross-over clinical trial. the study is designed to evaluate the safety and local tolerability of da-6034 upon single and repeated-dose topical application to the both eyes in healthy volunteers.


Eligibility criteria:
inclusion criteria: * 20-50 year-old healthy subjects exclusion criteria: * presence or history of dry eye or other ocular or systemic diseases * corrected visual acuity less than 20/40 in either eye at the screening * any eye surgery or laser eye surgery within the past six months * intraocular pressure greater than 22 mmhg in either eye at the screening * break-up time less than 10 sec with osdi score corresponding to mild to severe dry eye symptoms in either eye at the screening * unanesthetized schirmer scores \<10 mm in either eye at the screening

Keywords: eye drop, dry eye
functional mri in lupus nephritis

Conditions: Healthy; Lupus Nephritis

Summary: the primary objectives of the study are as follows: to develop and optimize a renal functional magnetic resonance imaging (mri) protocol consisting of diffusion-weighted magnetic resonance imaging (dw-mri), blood-oxygen- level-dependent mri (bold-mri), arterial spin labeling mri (asl-mri), phase contrast mri (pc-mri), and t1rho-mri; to compare renal functional mri cross-sectional readouts between normal healthy volunteers (nhv) and lupus nephritis (ln) participants. the secondary objectives of this study are as follows: explore whether renal functional mri techniques discriminate between renal inflammatory activity and damage in lupus nephritis (ln); to examine whether renal functional mri measurements correlate with laboratory features of renal involvement and renal function in participants with lupus nephritis (ln).


Eligibility criteria:
key inclusion criteria: * must have a documented diagnosis of systemic lupus erythematosus (sle) according to current american academy of rheumatology (acr) criteria. at least 4 american academy of rheumatology (acr) criteria must be documented, 1 of which must be a positive antinuclear antibody (ana), anti-sm, or anti-double stranded dna antibody. * must have a standard of care renal biopsy for lupus nephritis performed or scheduled within +/-7 days of day 1. key exclusion criteria: * has a metal device affected by magnetic resonance imaging (mri )(e.g., any type of electronic, mechanical, or magnetic implant; cardiac pacemaker; aneurysm clips; implanted cardiac defibrillator), or has potential ferromagnetic foreign body (metal slivers, metal shavings, other metal objects) that would be a contraindication for magnetic resonance imaging (mri). * history of renal transplant. * subjects with uncontrolled diabetes or other condition that may result in significant renal disease. note: other protocol-defined inclusion/exclusion criteria may apply.

Keywords: lupus nephritis normal healthy volunteer mri
effect of tens in children with spastic cerebral palsy

Conditions: Cerebral Palsy

Summary: tens is cheap and simple tool for physiotherapist, free of many side effects compared with other tools. so the aim of study was record the effect of tens on calf muscle tone in spastic cerebral palsy children.

the significance of this study is to determine whether tens could have an immediate effect on reduction of spasticity in children diagnosed with spastic cerebral palsy by studying the change of spasticity of ankle plantarflexors immediately after applying tens to the ankle dorsiflexors. muscle tone assessment will be applied before and after the application using objective tool which is electromyography and subjectively by using modified ashworth scale and goniometer, to be insured is there is an immediate effect of tens on muscle tone of calf muscle or not.

Eligibility criteria:
inclusion criteria: * the children will be included in this study is according to the following criteria 1. cerebral palsy spastic diaplegia. 2. their age ranged from 3-10 years. 3. both sexes were included. 4. the subjects with mild to moderate muscle tone according to mas in which mild is 1 and 1+ , and moderate is 2. exclusion criteria: * the subject will be excluded if he/she has one or more of the following criteria: 1. children with a history of seizures. 2. children who could not lie prone for any cause. 3. children who could not react to pain. 4. children who had applied any surgical procedure which affect muscle tone or any inhibitory injections like botox.

Keywords: tens
the invigorate 2 trial: a clinical trial to assess the efficacy and safety of subjects with seasonal allergic conjunctivitis

Conditions: Allergic Conjunctivitis

Summary: the invigorate 2 trial: a single-center, randomized, double-masked, crossover design, vehicle-controlled, phase 3 clinical trial to assess the efficacy and safety of reproxalap ophthalmic solution (0.25%) compared to vehicle in subjects with seasonal allergic conjunctivitis using the environmental exposure chamber (eec).


Eligibility criteria:
inclusion criteria: * be at least 18 years of age at the time of screening of either sex or any race; * provide written informed consent; * be willing and able to follow instructions, and can attend all required clinical trial visits. * have at least a two-year history of moderate-to-severe ragweed-induced allergic conjunctivitis based on investigator's judgement; * have a positive skin prick test to ragweed pollen within the past year of the medical screening visit (visit 1). exclusion criteria: * have a history of blepharitis, dry eye syndrome, herpes simplex keratitis, or herpes zoster keratitis; * have systemic signs of infection (e.g., fever, current treatment with antibiotics). * have a systemic disease or uncontrolled medical condition, which, in the opinion of the investigator, could interfere with clinical trial measurements or subject compliance. such diseases or conditions would include, but are not limited to, cancer, alcoholism, drug dependency or abuse, or psychiatric disease; * be a wocbp who is pregnant, nursing, or not using an effective means of contraception; * have any known contraindication or hypersensitivities to any components of the investigational product (ip) drug formulation.
a study for patients with attention-deficit/hyperactivity disorder treated with atomoxetine

Conditions: Attention Deficit Hyperactivity Disorder

Summary: the purpose of the study is to investigate the relationship of changes in measures of academic performance and problem behaviors, to changes in core attention-deficit/hyperactivity disorder (adhd) symptoms in asian children treated with atomoxetine.


Eligibility criteria:
inclusion criteria: * male or female outpatients between 8 and 11 years of age at study entry * attention-deficit/hyperactivity disorder (adhd) meeting the diagnostic and statistical manual of mental disorders fourth edition, text revision (dsm-iv-tr) disease diagnostic criteria * patients who have never received medications psychotropic medications specifically to treat adhd, or if they have received medication, that the trial of the psychotropic medication(s) was of less than 1 month duration, and occurred more than 6 months prior to study entry * normal intelligence in the judgment of the investigator * must be able to swallow capsules exclusion criteria: * current or past history of bipolar i or ii disorder, psychosis, autism, asperger's syndrome, pervasive developmental disorder, or conduct disorder * history of seizure disorder or currently taking anticonvulsants for seizure control * serious suicidal risk as determined by investigator * cardiovascular disease; current or past history of hypertension * previous treatment with atomoxetine
the role of trans-spinal direct current stimulation (tsdcs) in treating patients with hand spasticity after stroke

Conditions: Stroke; Cerebrovascular Accident (CVA); Hemiparesis; Spasticity as Sequela of Stroke; Muscle Spasticity; Upper Extremity Paralysis

Summary: the purpose of this study is to evaluate if 5 consecutive sessions of pathmaker anodal doublestim treatment, which combines non-invasive stimulation of the spinal cord (tsdcs- trans-spinal direct current stimulation) and of the median nerve at the peripheral wrist (pdcs-- peripheral direct current stimulation), can significantly reduce spasticity of the wrist and hand after stroke.


Eligibility criteria:
inclusion criteria: 1. first single focal unilateral hemisphere lesion with diagnosis verified by brain imaging (mri or ct scans) that occurred at least 6 months prior 2. cognitive function sufficient to understand the experiments and follow instructions 3. a modified ashworth scale score between 1-3 points for wrist flexor and extensor muscles 4. a minimum of 15 degrees wrist passive range of motion (rom) for wrist flexion and extension from wrist neutral position exclusion criteria: 1. focal brainstem or thalamic infarcts 2. prior surgical treatments for spasticity of the upper limb 3. ongoing use of central nervous system (cns)-active medications 4. ongoing use of psychoactive medications, such as stimulants, antidepressants, and anti-psychotic medications 5. botox or phenol alcohol treatment within 12 weeks of enrollment 6. pregnancy in women, as determined by self-report 7. history of spinal cord injury or weakness 8. chronic pain 9. peripheral neuropathy including insulin dependent diabetes as determined by case history 10. presence of additional potential tsdcs risk factors: * damaged skin at the site of stimulation (i.e., skin with ingrown hairs, acne, razor nicks, wounds that have not healed recent scar tissue, broken skin, etc.) * presence of an electrically, magnetically or mechanically activated implant (including cardiac pacemaker), an intracerebral vascular clip, or any other electrically sensitive support system * highly conductive metal in any part of the body, including metal injury to the eye (jewelry must be removed during stimulation) * past history of seizures or unexplained spells of loss of consciousness during the previous 36 months

Keywords: stroke cva spasticity hemiparesis rehabilitation trans-spinal direct current stimulation (tsdcs) non-invasive stimulation
a lot-to-lot consistency (3 lots of gsk biologicals' 10-valent pneumococcal conjugate vaccine) & non-inferiority study

Conditions: Infections, Streptococcal

Summary: evaluate lot-to-lot consistency, safety and reactogenicity of 3 doses of gsk biologicals' 10-valent pneumococcal conjugate vaccine and non-inferiority with respect to prevenar.

test groups: 4 (400 subjects/group). 3 groups receiving 10-valent pneumococcal conjugate vaccine (3 different lots) as follows: - 10-valent vaccine (lot 1, 2 or 3) + dtpa combined vaccine; control group receiving prevenar + dtpa combined vaccine

Eligibility criteria:
inclusion criteria: * male or female between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, free of obvious health problems and with written informed consent obtained from the parent/guardian of the subject. exclusion criteria: * use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceeding the first dose of study vaccine, or planned use during the study period. * planned administration/ administration of a licensed vaccine not foreseen by the study protocol during the period starting from one month before the first dose of vaccine(s) and during the entire study period.
follow up of high myopic eyes

Conditions: Pathologic Myopia

Summary: in this non-interventional retrospective and prospective observational study, the long-term evolution of clinical and iconographic characteristics of patients with pathological myopia will be considered changes of some specific clinical, tomographic and angiographic variables evaluated on the baseline and after a minimum of 5 years follow-up will be studied.


Eligibility criteria:
inclusion criteria: - high myopia exclusion criteria: * acute ischemic optic neuropathy * macular and peripapillary atrophy * other forms of maculopathy