Kornimate/medical-research-clean huggingface dataset:
a study to compare and evaluate the pharmacokinetic characteristics and the safety between administration of br2021 and br2021-1

Conditions: Metastatic Adenocarcinoma of the Pancreas

Summary: the purpose of this clinical study is to compare and evaluate the pharmacokinetic characteristics and the safety between administration of br2021 and br2021-1 in patients with metastatic adenocarcinoma of the pancreas


Eligibility criteria:
inclusion criteria: * those with histologically or cytologically proven metastatic adenocarcinoma of the pancreas * those who agree to rule out the possibility of their and their spouses' or sexual partners' pregnancy by using medically recognized methods of contraception (contraceptives administration \& transplantation or intrauterine device(iud), sterilization(vasectomy, tubal ligation, etc.), barrier methods (spermicide \& male condom, combined use of contraceptive diaphragm, sponge or cervical cap)) from the date of the first administration of the investigational products to at least 6 months after the last administration date and disagree to provide their sperm or ovum. * those who spontaneously decide to participate and sign written consent to comply with the subject's precautions after listening to and fully understanding detailed explanation of this clinical trial exclusion criteria: * in the case of a female subject, pregnant woman or those suspected pregnancy or lactating woman. * those who have to administer this study's contraindicated drugs with the investigational product from 2 weeks before the participation until end of this study * those who can't discontinue a diet (ex. raw grapefruit, grapefruit juice or food containing grapefruit, etc.) that may affect the absorption, distribution, metabolism, and excretion of the drug from 48 hours before the first administration date to post study visit(psv) * those who can't discontinue other drugs except the investigational product of this study that may affect the metabolism and excretion of the drug for the entire study period (however, if necessary, such as treatment of adverse event, it can be administrated according to investigator's judgment) * those who have participated in other clinical trials(including bioequivalence tests) and administered their investigational products within 4 weeks before the first administration date (however, the termination for participation in other clinical trials are based on the last administration date of their investigational products) or those whose last administration date of their investigational products of other clinical trials doesn't elapse five times the half-life of their investigational products based on the first administration date of investigational product of this study
split-belt treadmill training for freezing of gait in parkinson's disease

Conditions: Parkinson Disease; Freezing of Gait; Split-belt Treadmill

Summary: a split-belt treadmill (sbt) is a treadmill with two belts, whereby each leg can be driven at a different speed. previous work by the investigators showed that one session of sbt training improved turning while multi-tasking and reduced fog in pwpd tested in the laboratory. however, subsequent work raises questions as to whether treadmill improvements following repeated sbt training generalize to overground situations in the long term. therefore, in this study, the investigators will perform a four-week sbt intervention with added practice of everyday turning scenarios (sbt+cp) or placebo exercise (sbt+pl), and study its effects on fog in both the laboratory and at home.


Eligibility criteria:
* be between 40 - 90 years of age * have a diagnosis of parkinson's disease * be able to walk for 10 min without an aid * be able to follow and understand the oral instructions of the investigator * have a disease stage of i to iv (while on-medication) * have had no change in your parkinson's medication in the past month (or to your deep brain stimulator if applicable) and also no planned changes in medication over the next 4 months * have at least about 1 "freezing" episode per day (based on the new freezing of gait questionnaire: n-fog) * not participating in another clinical trial * have no acute joint disease * not have any other condition that affects your walking pattern or prevents you from completing all study tasks * have not undergone major surgery or hospitalization in the last 3 months * no substance abuse * no depressive disorder or other apathetic disorder that precludes daily exercise
efficacy and safety of tenofovir plus lamivudine plus efavirenz regimen as first-line antiretroviral therapy

Conditions: AIDS/HIV PROBLEM

Summary: this study aims to evaluate the safety and effectiveness of the tenofovir disoproxil fumarate (tdf) + lamivudine (3tc) + efavirenz (efv) regimen in antiretroviral therapy (art)-naive chinese hiv/aids patients.

this study is a prospective, open-label, multi-centered clinical trial to assess the virologic suppression and immune recovery rates as well as tolerability of the regimen 3tc+tdf+efv in arv-naive chinese population. 500 eligible participants will be recruited to take the regimen if the patient fails to tolerate efv, it can be substituted by nvp when cd4 \ 250/ul. if the patient fails to tolerate tdf, azt will be an alternative, except when hb \< 90/l or neutrophil count \< 0.75×109/l. the participants will be followed up by months 0.5, 1, 2 ,3 and every 3 months subsequently for 2 years. the efficacy of the regimen will be evaluated by comparison between different points along the time line and previous regimens. the safety of the regimen will be assessed by monitoring kidney function, bone density, cardiovascular profile, lipid profile, liver function etc as well as other adverse events.

Eligibility criteria:
inclusion criteria: * age between 18-65 years of either gender * hiv-1 antibody seropositive detected by elisa and confirmed by western blot * cd4 cell count \< 500/ul * signed informed consent, with no condition that precludes follow-up for 2 years * no plan to move out of the area during the trial * antiretroviral therapy naive exclusion criteria: * patients in acute phase of hiv infection * patients with ongoing opportunistic infection or aids-related malignancies; or with opportunistic infection within previous 3 months and still unstable within 14 days before inclusion * patients with the any of the following test results during screening for inclusion: * wbc count \< 2000/ul, * neutrophil count \< 1000/ul, * hb \< 9g/dl, * platelet count \< 75000/ul, * serum creatinine \> 1.5 uln, * transaminases or alkaline phosphatase \> 3 uln, * total bilirubin \> 2 uln, * serum creatinine kinase \> 2 uln * ccr \< 60ml/min * pregnancy and breastfeeding * intravenous drug user * severe neuropathy or mental disorder * history of alcohol abuse and unable to withdrawal * severe peptic ulcer disease * non-chinese nationality
influencing factors on gait variability in pd

Conditions: Parkinson Disease

Summary: the principal motor features of parkinson's disease (pd) include rigidity, tremor, bradykinesia, and postural instability. these motor deficits might cause gait dysfunction including reduced gait velocity, stride length, arm swing, and increased gait variability. among these, increase in gait variability increased fall risk and served as a marker of disease progression. previous studies reported that some factors might influence gait variability. however, which one contributes most has not yet been verified. therefore, the purpose of the present study is to identify the more related influencing factors on gait variability in people with pd.


Eligibility criteria:
inclusion criteria: * idiopathic pd * hoehn and yahr stages i through iii * ability to stand and walk 5 m independently with or without any walking aids * stable medication usage exclusion criteria: * unstable medical conditions * any neurological, cardiopulmonary or orthopedic problem/diseases that may interfere with participating the study

Keywords: parkinson's disease, gait variability
the effect of atorvastatin on androgens, glucose metabolism and inflammation in polycystic ovary syndrome (pcos) women

Conditions: Polycystic Ovary Syndrome

Summary: this is a placebo controlled trial investigating the effect of 6 months atorvastatin 20mg/day therapy on androgens, glucose metabolism and inflammatory markers in women with pcos. we assume that during 6 months atorvastatin therapy a significant improvement in hyperandrogenism, glucose metabolism and inflammatory markers is observed.

30 women diagnosed for pcos (aged 30-50 years) are enrolled for the study. 15 women are randomized in the atorvastatin group and 15 in the placebo group. the women with pcos participating in the study are required to use safe non-hormonal contraception during the medication. the study includes transvaginal ultrasonography, serum samples, oral glucose tolerance test (ogtt) and intra venous tolerance test (ivgtt) before and after receiving 6 months atorvastatin 20mg/day therapy or placebo. measurements for androgen levels, pituitary hormones, glucose, insulin and inflammatory markers are performed.

Eligibility criteria:
inclusion criteria: * diagnosed for pcos (rotterdam criteria) * aged 30-50 years * safe non-hormonal contraception exclusion criteria: * use of cholesterol lowering agents * use of antidepressants * use of cortisone medication (p.o.) * use of hormonal contraception * nursing * pregnancy * dm-t2 * liver disease * menopause * kidney or liver failure

Keywords: pcos atorvastatin androgens glucose metabolism inflammatory markers
psychological outcomes from a study of acupuncture treatment on experimentally primary dysmenorrhea

Conditions: Primary Dysmenorrhea

Summary: the objective of this study is to evaluate the associations between deqi, the effects of acupuncture and personality in primary dysmenorrhea and to characterize the nature of the deqi phenomenon on terms of the prevalence of sensations as well as the uniqueness of the sensations underlying the deqi experiment.

the mechanism, by which acupuncture works is not yet clear, therefore there is no unequivocal consensus about styles and sensations of acupuncture. whether psychological factor has influences on the effects of acupuncture? this study will adopt international practices such as visual analogue scale (vas) to objective evaluation. the confident degree, feeling degree for acupuncture and pain intensity were evaluated by the patient with vas, and the pain vas scores before and after acupuncture were recorded as the indexes for assessment of the therapeutic effect.

Eligibility criteria:
inclusion criteria: 1. female, age between 18 and 30 years old, who had regular menstrual cycles (28-33 days); 2. meeting diagnostic criteria for primary dysmenorrhea, having moderate to severe symptoms when unmedicated, and eligible for care through the military health system. exclusion criteria: 1. secondary dysmenorrhea; 2. women with systemic disease, or hormonal, psychiatric or gynecologic disorders, or substance abuse; 3. pregnant or trying to conceive, using oral contraceptives, smoker, breast-feeding.

Keywords: primary dysmenorrhea deqi acupuncture psychology
phase 1, single dose study to evaluate safety, pharmacokinetics, and pharmacodynamics of medi5884

Conditions: Healthy Volunteers

Summary: a phase 1, single dose study with 4 cohorts of ascending doses and an optional japanese cohort designed to evaluate the safety, pharmacokinetics, and pharmacodynamics of medi5884 in healthy volunteers

this is a first time in human, phase 1, randomized, blinded, placebo-controlled study to evaluate the safety, pharmacokinetics and pharmacodynamics of single ascending subcutaneous doses of medi5884 in healthy volunteers (age 18-55). the study consists of 4 cohorts of increasing doses (8 subjects each) and an optional japanese american cohort (24 subjects) for a total of 56 healthy subjects. the decision whether or not to dose escalate will be based upon data review by the dose escalation committee. subjects will be randomized 3:1 to medi5884 or placebo. following screening, the study consists of a 3 day inpatient stay and follow up visits. the number of follow up visits depend on the cohort assigned.

Eligibility criteria:
inclusion criteria: * healthy volunteers aged 18-55 years * must provide written informed consent * ability and willingness to adhere to the protocol * bmi 18-30kg/m2 * females not of childbearing potential * males must practice 2 effective contraceptive measures if sexually active * japanese descent for the japanese cohort exclusion criteria: * any concurrent condition that in the opinion of the investigator would interfere with the evaluation of the investigational product * history or presence of gastrointestinal, renal, or hepatic disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs * abnormal lab values, physical exam, vital signs * any clinically important illness, medical/surgical procedure, or trauma within 4 weeks prior to dosing * positive hepatitis b, hepatitis c or hiv test * receipt of investigational therapy with 4 months from screening * current or previous use of systemic corticosteroids 60 days prior to dosing or lipid lowering medications 28 days prior to dosing * abnormal ecg * recent plasma or blood donation * positive drug or alcohol screen. * current smoker

Keywords: atherosclerosis; acute coronary syndrome; medi5884
a study of 2 doses of map0010 in asthmatic children

Conditions: Asthma

Summary: the purpose of this study is to examine the safety of two doses of map0010 in asthmatic children, 12 months to 8 years of age, over a 40-week period.


Eligibility criteria:
inclusion criteria: * completed 12 weeks of treatment in the map0010-cl-p301 study. * patient, parent, and guardian (as appropriate) are willing for child to undergo all study procedures and willing to sign the informed consent and assent, as appropriate. exclusion criteria: * less than 80% compliance with either study treatment and/or other study procedures (e.g., completion of symptom e-diary) in the map0010-cl-p301 study.

Keywords: asthmatic children
endoscopical dilation of benign esophageal strictures

Conditions: Dysphagia

Summary: although balloon dilatation is the primary treatment for benign dysphagia, information about the optimal inflation time is lacking. the aim of the current pilot study was to compare 10 seconds inflation time, with 2 minutes inflation time, regarding the efficacy


Eligibility criteria:
inclusion criteria: * symptomatic dysphagia with an endoscopic picture suggestive of a benign disease exclusion criteria: * suspicion of achalasia or malignancy. if the patients needed more than 3 dilations the first month this was also a considered an exclusion criterion

Keywords: benign esophageal strictures esophagus balloon dilation
knee dislocation - clinical evaluation of the use of hinged external fixator after ligament reconstruction

Conditions: Knee Dislocation

Summary: knee dislocation is a serious injury, usually caused by high-energy trauma. it is classically defined as complete loss of articular congruence between the femur and the tibia, confirmed by radiography. however it is common that the reduction happens spontaneously. for this reason, today the investigators also consider a patient suffered knee dislocation in the presence of multi-ligament injury involving the posterior cruciate ligament, often in association with anterior cruciate ligament, lateral and/or medial ligamentous complex. it is considered a serious injury, because both the strong association with vascular and nerve damage, which can lead to the need for limb amputation, such as the difficulty in obtaining a good functional outcome even after treatment of all ligament injuries. the treatment of these injuries aims to achieve knee stability. joint mobility is often sacrificed in the postoperative period, with the use of immobilizations such as casts, splints or bracing. unfavorable clinical outcomes with high rates of stiffness and joint pain are very common in these patients. in attempts to improve these results, rehabilitation protocols with early range of motion can be employed. however, results may remain unsatisfactory, predominantly because of knee instability recurrence. stannard and zaffagnini proposed a new model for treatment of acute knee dislocations. in this model, after multi-ligament reconstruction or repair, a knee articulated external fixator is used. such external fixator allows early and aggressive joint mobility in the sagittal plane only. flexion and extension are permitted, but rotational movements, translations in the anterior-posterior plane, lateral (varus) and medial (valgus) openings are not allowed. thus protective stability is ensured for ligament reconstruction procedures. simultaneously the investigators allow immediate joint mobilization, reducing the risk of arthrofibrosis, joint stiffness and postoperative ligament laxity. there is no consensus regarding the use of hinged external fixator postoperatively in multiple ligament reconstruction procedures for treatment of knee dislocations. the objective of this study is comparing functional outcomes after ligament reconstruction in patients with knee dislocation, with or without the use of hinged external fixator.


Eligibility criteria:
inclusion criteria: * adults aged between 18 and 50 years old, diagnosed with knee dislocation, classified as kd-iii and kd-iv * absence of knee arthritis in initial radiographs * absence of systemic diseases or disorders of collagen altering bone quality * absence of previous surgical interventions in the knee * possibility of using medications * maximum of three months of injury to treatment * understanding and acceptance by the patient to participate exclusion criteria: * abandoning medical care * inability to follow the treatment plan
the thai surgical intensive care study (thai-sicu study)

Conditions: Complications of Surgical and Medical Care: General Terms; Adverse Reaction to Drug; Sequelae of External Causes of Morbidity and Mortality; Critical Illness

Summary: the study observed the 28 days mortality of 9 participated university base surgical intensive care unit (sicu) as well as the occurrence of adverse events in sicu.

the adverse events included pulmonary aspiration, pulmonary emboli, drug error, new stroke, symptomatic deep vein thrombosis, pneumothorax, unplanned extubation, upper gi hemorrhage, myocardial infarction, abdominal hypertension, acute lung injury(ali)/acute respiratory distress syndrome (ards), re-intubation within 72 hours, delirium, cardiac arrest, new arrhythmia, acute kidney injury, sepsis

Eligibility criteria:
inclusion criteria: * all sicu admission patients exclusion criteria: * age \< 18 years

Keywords: adverse events mortality readmission surgical intensive care unit
racecadotril versus standard treatment in decreasing the duration of acute diarrhoea in children

Conditions: Diarrhoea

Summary: acute watery diarrhea is defined as the passage of 3 or more loose or liquid stools per day for 3 or more days but less than 14 days, including patients with mild to moderate dehydration per who classification. the study's outcome variables are stool frequency, measured by the total number of stools passed during 24 and 48 hours from the initiation of treatment, and hospital duration, measured by the total duration of hospital stay in hours. the null hypothesis states that racecadotril combined with standard treatment has no effect on reducing the mean number of stools passed during 48 hours compared to standard treatment alone in pediatric patients with acute watery diarrhea, while the alternate hypothesis suggests that racecadotril combined with standard treatment will significantly reduce the mean number of stools passed during 48 hours compared to standard treatment alone in these patients.


Eligibility criteria:
inclusion criteria: * hospitalized patients with acute watery diarrhea of both genders who are 1. age: 03 months to 05 years 2. present in first 24 hours of onset of disease. exclusion criteria: 1. parenteral diarrhea 2. chronic diarrhea like coeliac disease, lactose intolerance 3. mal-absorption syndromes 4. diarrhea related to food poisoning, dysentery as suggested by history 5. severe dehydration patents who are vitally unstable. 6. diarrhea associated with measles. 7. persistent vomiting 8. abdominal distention 9. patients allergic to racecadotril 10. patients managed before enrolled to study

Keywords: stool diarrhoea paediatrics
xerostomia-optimised imrt versus standard imrt in npc

Conditions: Nasopharyngeal Carcinoma ,Xerostomia,Radiotherapy

Summary: this is a multi-center, non-inferiority, open-label, randomized controlled phase iii clinical trial in primary diagnosed nasopharyngeal carcinoma (npc) patients without distant metastasis. this study aims to compare the regional control, survival outcomes, radiation-related toxicities, and quality of life (qol) of xerostomia-optimized intensity-modulated radiotherapy versus standard intensity-modulated radiotherapy in npc patients

xerostomia remains one of the most common radiation-induced toxicities, and approximately 80% to 90% of npc patients still experience varying degrees of xerostomia post-imrt. among the major salivary glands, the parotid gland is the largest and produces 60% to 65% of the oral saliva output. studies have revealed that xerostomia post-imrt is mainly dependent on the irradiation dose of the parotid glands. clinical target volumes (ctv) for the cervical nodal region starting from skull base have been the standard in nasopharyngeal carcinoma for several decades. consequently, the parotid glands overlap with the target volumes and irradiation dose reaches 31.7 gy to 43.9 gy in most reports. retrospective studies reveal that the lateral process of c1 is a suitable cranial edge for neck ctv delineation; therefore, the volume of the parotid glands exposed to high radiation doses can be greatly reduced. we conducted this trial comparing outcomes ,toxicities and qol of xerostomia-optimized intensity-modulated radiotherapy versus standard intensity-modulated radiotherapy in nasopharyngeal carcinoma.

Eligibility criteria:
inclusion criteria: * newly histologic diagnosis of nasopharyngeal non-keratinizing carcinoma (who ii/iii); * all genders, range from 18-70 years old; * ecog score 0-1; * clinical stage i-iva (ajcc/uicc 8th); * not received radiotherapy, chemotherapy and other anti-tumor treatment (including immunotherapy); * no contraindications to chemotherapy or radiotherapy; * adequate organ function: white blood cell count ≥ 4×109/l, neutrophile granulocyte count ≥ 1.5×109/l, hemoglobin ≥ 90g/l, platelet count ≥ 100×109/l; alanine aminotransferase or aspartate aminotransferase \< 2.5×upper limit of normal; blood urea nitrogen or creatinine ≤ 1.5×upper limit of normal or endogenous creatinine clearance ≥ 60ml/min (cockcroft-gault formula); * sign the consent form. exclusion criteria: * level ii involvement with extracapsular extension (ece), and/or had a maximum nodal axial diameter (mad) of greater than 3cm in level ii ; -≥4 nodal regions of ipsilateral neck involvement; * radiologically suspicious or confirmed involvement in level ii area between skull base and the lateral process of c1; * parotid lymph node and/or parotid gland involvement; * history of parotid disease or surgery; * previous malignancy or other concomitant malignant disease; * pregnancy or lactation.