Kornimate/medical-research-clean huggingface dataset:
study of hepatitis c virus (hcv) nonstructural protein 5a (ns5a) inhibitor idx719 in healthy and hcv-infected participants (mk-1894-001)

Conditions: Hepatitis C, Chronic

Summary: the purpose of the study is to test the safety and tolerability of different doses of idx719 to find the best dose for future studies. the study will also assess the pharmacokinetics of idx719. no formal hypotheses will be tested.


Eligibility criteria:
inclusion criteria: * all participants * is in good general health. * agrees to use double-barrier method of birth control for at least 90 days after the last dose of study drugs. * hcv participants * has documented gt1, gt2, or gt3 chronic hcv infection. exclusion criteria: * all participants * is pregnant or breastfeeding. hcv participants * has received prior hcv treatment. * is co-infected with hepatitis b virus (hbv) and/or human immunodeficiency virus (hiv).

Keywords: hepatitis c hcv treatment-naive
a study to compare pk, pd and safety of the ad-206 and esomeprazole

Conditions: Gastritis

Summary: a study to compare safety, pharmacokinetics and pharmacodynamics of ad-206 to esomeprazole in healthy male volunteers.

this study is to compare the safety, pharmacokinetic characteristics and pharmacodynamic characteristics of ad-206 compared with administration of esomeprazole in healthy male subjects.

Eligibility criteria:
inclusion criteria: * age 19\~50 years in healthy male volunteers * bmi is more than 18 kg/m\^2 , no more than 27.0 kg/m\^2 * subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing exclusion criteria: * presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system * subjects who judged ineligible by the investigator
secondary prevention in type 2 diabetes: comparison of two different resistance exercise training protocols

Conditions: Type 2 Diabetes Mellitus

Summary: skeletal muscle accounts for up to 40% of the total body weight and is responsible for approximately 75% of the whole body insulin-stimulated glucose uptake. resistance training has been shown to improve insulin-stimulated glucose uptake in patients with t2dm. therefore the investigators aim to compose the effects of 2 different resistance training protocols in combination with aerobic endurance training (aet) on muscle strength, muscle mass and glycemic control in type 2 diabetes mellitus patients (t2dm). the investigators aim to perform an 8 week randomized controlled training intervention in 32 t2dm patients. patients will be randomly assigned to aet (cycle ergometer, 60-70% of heart rate reserve) combined with hypertrophy resistance training (hrt, n=16, 2 sets, 10-12 repetitions, 70% of the one-repetition maximum) or with endurance resistance training (ert, n=16, 2 sets, 25-30 repetitions, 40% of the one-repetition maximum). body composition, blood analyses, physical work capacity and muscle strength will be measured pre- and post-intervention.


Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus exclusion criteria: * myocardial infarction within the last 6 months * unstable angina pectoris * left ventricular ejection fraction less than 40% * orthopedic limitations that eliminate to perform resistance training

Keywords: diabetes mellitus type 2 diabetes t2dm resistance training hypertrophy training endurance training
effectiveness of iccms in reducing the incidence of dental caries in children

Conditions: Dental Caries

Summary: the aim of the present study is to evaluate the effectiveness of using the iccms (international caries classification and management system)in reducing caries lesions incidence compared to a control group that use different criteria as a not systematic and standardized prevention strategy. the study will be performed among children attending to the social project of social service of commerce (sesc), sao paulo. the sample will be composed of 460 children aging between 7 to 12 years old registered in curumim program from eight dental centers of sesc. a randomized controlled study with parallel group will be conducted. the centers will be randomized between the 2 strategies, defining 2 groups with 4 centers each. the experimental group that will follow the criteria defined by the iccms will evaluate clinical and behavioral variables, it will define: evaluation of the caries risk of the patient, evaluation of the intraoral risk, diagnosis of the caries lesion and its respective activity, plan decision individualized treatment for the patient and indication of recall interval according to the risk of caries. in the control group, children need will be solved according to rthe routinely dental practices in the center, but the determination of the child's general and intraoral risk of developing new caries lesions will not be performed nor the scheduling of specific recall intervals according to the risk.


Eligibility criteria:
inclusion criteria: * children who participate in the curumim program * children whose parents sign the term of informed consent confirming their participation. exclusion criteria: * children with cognitive impairment, motor impairment and feeding tube.

Keywords: dental caries, iccms, risk assessment
oral antibiotic bowel preparation in gynecologic oncology surgery

Conditions: Surgical Site Infection; Surgical Complication; Gynecologic Cancer

Summary: the purpose of this study is to investigate whether the use of a preoperative antibiotic bowel regimen is associated with a reduced risk of deep organ/space surgical site infection in gynecologic oncology surgery.

this is a retrospective chart review study. patients who underwent scheduled intra-abdominal surgery with a wellspan gynecologic oncologist will be identified and their chart reviewed for demographic data of age, race, bmi, comorbidities, and type of surgery. those patients who had a deep organ/space surgical site infection within 30 days postoperatively will be identified. the numbers of these infections before and after august 2020, at which time all patients moving forwards were prescribed antibiotic bowel preparation, will then be statistically analyzed and compared to see if the institution of the antibiotic bowel preparation was associated with a reduction in surgical site infection.

Eligibility criteria:
inclusion criteria: - underwent scheduled intra-abdominal surgery with a wellspan gynecologic oncologist exclusion criteria: * unscheduled surgery * intraoperative consult by a wellspan gynecologic oncologist

Keywords: surgical site infection gynecologic cancer
16.0040 ankylosing spondylitis study

Conditions: Ankylosing Spondylitis

Summary: the purpose of this study was to evaluate extended safety and efficacy of etanercept in adults with ankylosing spondylitis.

this multicenter, open-label extension study will evaluate the safety and clinical benefit of etanercept in the treatment of ankylosing spondylitis in subjects previously enrolled in protocol 16.0037.

Eligibility criteria:
inclusion criteria: - subjects completing 24 weeks of study drug in protocol 16.0037 qualify to enroll into this study other patients to meet the following criteria: * negative pregnancy test * subjects agree to use appropriate contraception throughout study * should be able to self-inject study drug or have someone who can do so * capable of understanding protocol and willing to provide written informed consent exclusion criteria: * any change in nsaid or prednisone dose within 2 weeks of baseline * any change in hydroxychloroquine, sulfasalazine, or mtx dose within 4 weeks of baseline * use of dmards other than those mentioned above, within 4 weeks of enrollment * previous receipt of ani-tnf agents, other than etanercept * receipt of any other investigational drug within 30 days of baseline * grade 3 or 4 adverse event attributed to etanercept which recurred when etanercept was resumed * abnormality in chemistry or hematology profiles or significant concurrent medical events.
online cognitive control training for remitted depressed patients

Conditions: Major Depression in Remission

Summary: this study evaluates the effectiveness of an internet-delivered cognitive control training as a preventive intervention for remitted depressed patients. half of the participants will receive a cognitive control training, while the other half will receive a low cognitive load training that acts as an active control condition.

prospective studies have linked impaired cognitive control to increased cognitive vulnerability for future depression. importantly, experimental studies indicate that cognitive control training can be used to reduce rumination and depressive symptomatology in mdd (major depressive disorder) and rmd (remitted depressed) samples. provided that remitted depressed patients form a high-risk group for developing future depressive episodes, the current study will explore whether an internet-delivered cognitive control training can be used to reduce vulnerability for future depression in remitted depressed patients. a computer training, consisting of 10 sessions of 15 minutes each, will be administered to participants, which are remitted depressed patients. this training can either be a cognitive control training, using an adaptive paced auditory serial addition task, or an active control training, with a low cognitive load task. dependent variables will be assessed pre- and post-training, as well as 3 and 6 months after the training, and consist of depressive symptomatology, related variables and cognitive control measures.

Eligibility criteria:
inclusion criteria: * history of ≥ 1 depressive episodes (major or bipolar) * currently in stable full or partial remission (≥ 3 months) exclusion criteria: * major depressive disorder (current or less than 3 months in remission) * bipolar disorder (current or less than 3 months in remission) * psychotic disorder (current and/or previous) * neurological impairments (current and/or previous) * excessive substance abuse (current and/or previous) * no ongoing psychotherapeutic treatment (maintenance treatment is allowed, but with a frequency of less than once every three weeks) * use of antidepressant medication is allowed if kept at a constant level

Keywords: depression remission relapse prevention cognitive control training internet intervention
effect of a follow on formula with lactobacillus fermentum on the incidence of infections

Conditions: Incidence of Infectious Diseases

Summary: the objective of the study is to evaluate the effects of a follow on formula containing the human milk probiotic lactobacillus fermentum on the incidence of infection in 6 months old infants.


Eligibility criteria:
inclusion criteria: * 6 months old children born at term * written consent from parents exclusion criteria: * frequent gastrointestinal disorders (frequent diarrhoeas, constipation episodes, gastroesophageal reflux) * gastrointestinal surgery * cow's milk protein allergy * metabolic diseases (diabetes or lactose intolerance) * immune deficiency * antibiotic treatment during the trial and/or recent (within the preceding 3 weeks)
remimazolam in high risk ercp patients

Conditions: the Severity and Duration of Intraoperative Hypotension

Summary: we conducted a randomized trial to investigate whether the administration of remimazolam in patients undergoing high-risk endoscopic retrograde cholangiopancreatography (ercp) could significantly reduce the occurrence of intraoperative hypotension, facilitate rapid induction, and result in fewer associated complications.

remimazolam is a novel ultra-short-acting benzodiazepine-like anesthetic used for gastrointestinal endoscopic procedures, characterized by predictable sedation duration and rapid recovery. propofol, commonly used in clinical practice as an intravenous anesthetic, also exhibits rapid onset, short duration, and quick recovery characteristics. to date, there is relatively limited literature comparing the likelihood of intraoperative hypotension during general anesthesia with these two agents in patients undergoing endoscopic retrograde cholangiopancreatography (ercp). additionally, a comparison is needed regarding the frequency of additional sedative doses required during anesthesia induction and the occurrence of major postoperative complications, including pancreatitis. therefore, the investigators we conducted a randomized trial to investigate whether the administration of remimazolam in patients undergoing high-risk ercp could significantly reduce the occurrence of intraoperative hypotension, facilitate rapid induction, and result in fewer associated complications. the investigators aimed to enroll 60 patients with a 1:1 ratio of asa iii to iv undergoing ercp. the investigators anticipate that remimazolam can reduce intraoperative hypotension, acute postoperative pancreatitis, and the occurrence of major organ complications.

Eligibility criteria:
inclusion criteria: * male and female subjects aged between 20 and 90 years old; * asa (american society of anesthesiologists) class iii to iv; * body mass index (bmi) between 18 and 30 kg/m². exclusion criteria: * uncontrolled hypertension or hypotension, or clinically significant coronary artery atherosclerosis heart disease or heart failure; * severe respiratory system disorders; * severe sinus bradycardia, heart conduction block, frequent ventricular arrhythmias, or atrial fibrillation; * clinically significant coagulation disorders; * end-stage liver failure or kidney disease requiring dialysis; * emergency surgery; * peripheral artery disease with upper limb functional impairment; * other conditions deemed inappropriate by the investigator, including patients with superficial pharyngeal cancer for whom rapid extubation is not suitable during ercp.
to explore the influence of longitudinal muscle on the prognosis of achalasia patients after peroral endoscopic myotomy (poem)

Conditions: Esophageal Achalasia

Summary: achalasia is a disease characterized by lack of peristalsis and lower esophageal sphincter failing to relax. longitudinal muscle, outer layer of esophageal smooth muscle, is recently found to be responsible for emptying of esophagus for achalasia patients, especially for those type ⅱcases. clinical observations also conclude that type ⅱ achalasia which still preserve longitudinal muscle response best to treatment, among the 3 types. thus, with high frequent intraluminal ultrasound, clinically applied as endoscopic ultrasound, to measure the function of longitudinal muscle in achalasia patients, the current research aims to explore the influence of longitudinal muscle on the prognosis of achalasia patients after peroral endoscopic myotomy, a routine treatment.


Eligibility criteria:
inclusion criteria: * diagnosed of esophageal achalasia * patients or legal surrogates willing and competent to give informed consent exclusion criteria: * postoperative or post-poem * post-pneumatic dilation or post-stenting * fail to go through high frequency intraluminal ultrasound （hfius) * patients with american society of anesthesiologists （asa） score ≥3
prospective evaluation of reverse end to side anterior interosseous nerve to ulnar nerve transfer for severe compressive ulnar neuropathy at the elbow

Conditions: Severe Compressive Ulnar Nerve Neuropathy (McGowan Grade III)

Summary: ulnar nerve compression at the elbow is a common problem and can significantly affect hand function in severe cases. the current, standard treatment is ulnar nerve decompression with or without transposition (moving the ulnar nerve to a site where there is less compression). in severe compression, the clinical results after this surgery are typically poor. distal transfers of functioning nerves (at the level of the wrist) to the compressed ulnar nerve (anterior interosseous nerve to ulnar motor fascicles) have been suggested to "supercharge" or augment hand muscles while nerve axons regenerate from the level of the elbow after decompression/transposition. in fact, this treatment is becoming widely adopted without clear evidence that it changes outcomes. the investigators propose to prospectively compare the effectiveness of ulnar nerve decompression/transposition versus decompression/transposition and distal nerve transfer.

the purpose of this study is to prospectively compare the outcomes of patients with severe (intrinsic hand muscle dysfunction) compressive ulnar neuropathy at the elbow treated with ulnar nerve decompression and subcutaneous transposition alone versus ulnar nerve decompression with subcutaneous transposition and ain to ulnar nerve reverse end-to-side transfer. the study objectives of this project are the following: 1. to prospectively compare the clinical outcomes of patients with severe ulnar neuropathy at the elbow who receive ulnar nerve decompression with subcutaneous transposition and ain to ulnar motor reverse end-to-side nerve transfer versus decompression and subcutaneous transposition alone. 2. to prospectively compare the electrophysiologic outcomes (nerve conduction studies and emg) of patients with severe ulnar neuropathy at the elbow who receive ulnar nerve decompression with subcutaneous transposition and ain to ulnar motor reverse end-to-side nerve transfer versus decompression and subcutaneous transposition alone.

Eligibility criteria:
inclusion criteria: * adult patients (greater than 18 years) with severe compressive ulnar nerve neuropathy (mcgowan grade iii) at the elbow who consent to either ulnar nerve decompression with transposition alone or ulnar nerve decompression with transposition plus nerve transfer. exclusion criteria: * patients under the age of 18 and over 70. * patients with ulnar neuropathy at multiple anatomic locations along the course of the nerve. * patients with mild to moderate ulnar neuropathy (mcgowan grade i and ii).
antimycotic prophylaxis in pediatric patients following allogeneic stem cell transplantation

Conditions: Systemic Aspergillosis; Systemic Candidiasis

Summary: pediatric patients are at high risk to acquire mycotic infections following allogeneic bone marrow transplantation. in the present retrospective analysis we assess the safety and efficacy of different regimens in antimycotic prophylaxis.


Eligibility criteria:
inclusion criteria: * pediatric patients under the age of 18 years * pediatric patients after hsct treated with caspofungin * pediatric patients after hsct treated with liposomal amphotericin exclusion criteria: * pediatric patients with uncontrolled hematological malignancies * pediatric patients with ifi at start of hsct
changes in trans tibial amputee running asymmetry during prolonged effort

Conditions: Amputation, Traumatic

Summary: the purpose of this study is to determine the effect of prolonged effort in long distance running on the biomechanical bilateral asymmetry in the lower limbs of trans tibial amputee running with running specific prosthesis.


Eligibility criteria:
inclusion criteria: * unilateral traumatic trans tibial amputee. * experience in running with running specific prosthesis. * ability to run for at least 20 minutes. exclusion criteria: * injury or other orthopedic or neurologic issue that compromises the gait.

Keywords: amputation, traumatic biomechanics asymmetry amputee running prolonged effort
preoperative intraarterial chemoembolization combined with radiotherpy in locally advanced rectal cancer

Conditions: Rectal Cancer

Summary: compared to postoperative chemotherapy combined with radiotherapy, preoperative chemotherapy combined with radiotherapy shows higher sphincter preservation rate and lower local recurrence rate in locally advanced rectal cancer. the purpose of this study is to evaluate the response and prognosis of intraarterial chemoembolization and intravenous infusion chemotherapy in patients with rectal t3-t4 and/or n+ rectal cancer before operation.


Eligibility criteria:
inclusion criteria: * histologic or cytologic diagnosis of rectal cancer, stage iv. * males or females between 18 years to 75 years. * no prior cisplatin-based chemotherapy or radiotherapy. * performance status of 0～2 on the ecog criteria. * adequate hematologic (leukocyte count \>= 4,000/ul, neutrophil count \>= 1,500/ul, hemoglobin \>= 10 g/dl, platelets \>= 100,000/ul), hepatic (ast \& alt =\< upper normal limit(unl)x1.5, bilirubin level =\< unlx1.5), and renal (creatinine =\< unl x1.5 or creatinine clearance rate ≥60 ml/min) function. * patient can take oral medicine * patient compliance that allow adequate follow-up. informed consent from patient or patient's relative. exclusion criteria: * patient with allergic to s-1 or ingredient of oxaliplatin * patient with peripheral neuropathy * diagnosed fibrosis of lung;pulmonary fibrosis or interstitial pneumonia within 28 days. * medically uncontrolled serious heart, renal failure, liver failure, hemorrhagic peptic ulcer, paralysis of intestine , ileus, poor controlled diabetes. * enrollment in other study. * pregnant or breast-feeding. * seriously psyche or intelligence problem. * inability to comply with protocol or study procedures.

Keywords: rectal cancer intraarterial chemoembolization radiotherpy oxaliplatin tegafur gimeracil and oteracil porassium capsule
0.3% sodium hyaluronate eye drop to prevent recurrent corneal epithelium exfoliation

Conditions: Corneal Epithelium Exfoliation

Summary: corneal abrasion (tca) is the most common ophthalmic emergency disease, accounting for about 10% of the american ophthalmic emergency, accounting for 22% of the ophthalmic emergency in zhongshan ophthalmic center. clinical emergency treatment of tca is relatively simple and effective, corneal epithelial damage can be recovered within 48 hours. however, about 25% tca would be developed to the recurrence of exfoliation. once the recurrence of tca, the treatment would be more difficult and even cause blindness. therefore, it is of great practical significance to prevent the recurrence of tca. however, there is no effective methods to prevent recurrence of tca. 0.3% sodium hyaluronate eye drops can effectively supplement the shortage of tear and promote repair of corneal epithelium. on this basis, the investigators hypotheses that 0.3% sodium hyaluronate eye drops can prevent the recurrence of tca. so, investigators intend to test effectiveness of 0.3% sodium hyaluronate drops to prevent the recurrence of tca by a prospective, single center, randomized, controlled pilot study. in this study, 60 patients with tca were randomly divided into control group and sodium hyaluronate treatment group and observed one year.


Eligibility criteria:
inclusion criteria: * definitive diagnosis of primary corneal epithelial abrasion; * monocular onset; * corneal epithelium was defected and fluorescein sodium staining was positive. exclusion criteria: * corneal epithelial defect complicated with infection * associated with other ocular surface disease patients (such as hypophasis, meibomian gland dysfunction, keratoconjunctivitis sicca syndrome, bullous keratopathy, corneal dystrophy and drug-induced corneal toxicity etc.) * pregnant or lactating women; serious heart, liver, and kidney dysfunction; mental disorders; other inflammatory or autoimmune diseases