Kornimate/medical-research-clean huggingface dataset:
mandibular overdenture retained by 1 or 2 implants: a cost-effectiveness analysis

Conditions: Edentulous Mouth

Summary: the aim of this study is to assess the cost-effectiveness of the mandibular overdenture retained by one and two implants, based on a randomized clinical trial.

this randomized clinical trial alongside a cost-effectiveness analysis will include 48 edentulous individuals who meet eligibility criteria. new maxillary and mandibular dentures will be fabricated for all participants following a standardized protocol. then, participants will be randomized into one of the treatment groups: mandibular overdenture retained by two implants group or single-implant mandibular overdenture group. each participant allocated to the single-implant mandibular overdenture group will then receive a straumann® standard plus slactive® regular neck implant (straumann 0.33.051s/052s/053s institute straumann ag, basel, switzerland) in the mandibular midline, and the mandibular overdenture retained by two implants group will receive two implants of the same specification, in the interphoramen region. a healing abutment will be connected and the implant will be allowed to heal for approximately 3 weeks. then, a 3.4mm retentive titanium anchor abutment (straumann 048.439, institute straumann ag, basel, switzerland) will be connected and tightened to 35 n.cm with a torque wrench. the matrix will be incorporated to the denture using self-curing acrylic resin and the patient will be instructed to keep the upper and lower dentures firmly occluded in the habitual position until the final polymerization of the resin. outcomes (satisfaction with the dentures and oral health-related quality of life) will be measured at baseline and at the 6- and 12-month follow-up. direct costs related to therapies in both groups will be identified, measured and valuated for one year after treatment. incremental cost-effectiveness ratios will be estimated and graphically presented on cost-effectiveness planes. sensitivity analysis on the most important assumptions will be performed in order to assess the robustness of the model.

Eligibility criteria:
inclusion criteria: * no contraindications for implant surgery (mainly related to uncontrolled systemic diseases) * present enough bone volume in the mandibular midline area for implant placement without the need of bone augmentation procedures. * be able to understand and answer the questionnaires used in the study * agree to participate by providing a written informed consent. exclusion criteria: * noncompliant participants * individuals who do not agree to be randomly allocated to the treatment study group * presence of signs of untreated temporomandibular disorders, uncontrolled systemic or oral conditions that require additional treatments

Keywords: overdenture dental implant cost analysis
safety study of dengzhanxixin (a chinese medicine injection) used in hospitals in china

Conditions: Ischemic Stroke; Coronary Heart Disease

Summary: this study was advocated by institute of basic research in clinical medicine, china academy of chinese medical sciences in october 2011. it was funded by china major scientific and technological specialized project for 'significant new formulation of new drugs'. dengzhanxixin is kind of chinese medicine injection used for treating ischemic stroke and coronary heart disease in many chinese hospitals. the purpose of this study is to determine adverse drug events or adverse drug reaction in large sample size 30,000 patients.

it is very common that chinese medicine injection used in hospitals in mainland china. however safety problems rose in recent years. there could be many uncertain factors influence chinese medicine injection in clinical practice. safety surveillance on chinese medicine injection is an important problem that needs to be sorted out through large sample observational study. a registry study for kudiezi injection safety surveillance with 30000 patients will be conducted from april.2012 to december.2014. eligibility criteria patients who will use dengzhanxixin injection in selected hospitals data will be collected in three aspects by three different forms as following: form a (green): demographic information ；form b (pink): adverse drug events/reaction； form c (white): extracted information from hospital information system and laboratory information system form

Eligibility criteria:
inclusion criteria: * patients using dengzhanxixin injection from 2012 to 2014 exclusion criteria: * none
modified percutaneous achilles tendon lengthening by triple hemisection for achilles tendon contracture

Conditions: Achilles Tendon Contracture

Summary: this study aims to evaluate the efficacy and safety of this new therapeutic method, which is based on the percutaneous sliding technique with three hemi-cuts in the tendon.

this study aims to provide a new therapeutic theory which bases on the percutaneous sliding technique with three hemi-cuts in the tendon. in this study, achilles tendon parenchymal at distal level is hemisected through the most distal incision, achilles tendon parenchymal at proximal level is hemisected through the middle incision, then achilles tendon lengthening is accomplished by the sliding tendon under forceful dorsiflexion. it can better achieve soft tissue balance and reduce the recurrence of achilles tendon contracture when achilles tendon strength in plantarflexion is weakened. thus in this study, the partial aponeurosis of gastrocnemius is cut off at most proximal incision in order to weaken achilles tendon strength in plantarflexion.

Eligibility criteria:
inclusion criteria: * patients older than three years old; * severe achilles tendon contracture and equinus; * the time after achilles tendon contracture more than 6 months ; * initial achilles tendon lengthening. exclusion criteria: * patients younger than 3 years; * the course of achilles tendon contracture is within 6 months; * patients who have suffered from the achilles tendon lengthening; * obvious contracture of other soft tissues occurs in combination, such as compartment syndrome or extensive scar tissues in calf; * osteotomy or tendon transposition is needed. * ankle joint is damaged obviously, such as charcot's joint or hemophilic arthritis; * skin soft-tissue infection in the lower limb. * initial achilles tendon lengthening.
prospective randomized trial of laparoscopic versus open liver resection for hcc

Conditions: Hepatocellular Carcinoma

Summary: short-term outcomes of laparoscopic liver resection is better than those of open liver resection laparoscopic liver resection is better than open resection in immunological aspects

advantages and disadvantages of the laparoscopic compared with the open approach for liver resections 1. advantages 1) less postoperative ascites production 2) reduced postoperative pain 3) feasible in selected cirrhotics who have contraindications to open surgery 4) less intra-abdominal adhesions (easier salvage transplantation) 5) shorter recovery time 6) shorter length of stay 7) reduced financial cost 2. disadvantages 1) no manual palpation or exploration of the liver parenchyma possible (with the pure laparoscopic approach) 2) high demand in surgical skill (especially major resections)

Eligibility criteria:
inclusion criteria: * radiologically diagnosed hepatocellular carcinoma * child classification a or b * aged 20 to 80 * informed consent taken exclusion criteria: * child classification c * extrahepatic metastasis * tumor located in central area or adjacent to middle hepatic vein * recurred hepatocellular carcinoma * critically ill patient * patient with psychiatric disease

Keywords: recurrence survival immunology laparoscopy
a real world, multi-centric, observational registry study of chronic kidney diseases

Conditions: Chronic Kidney Disease

Summary: chronic kidney disease (ckd) refers to a variety of different diseases characterized by impairment of kidney structure and/or renal function. the prevalence of ckd in china is as high as 10.8%. with a population of more than 150 million, china has the largest number of ckd patients all over the world. people with ckd would not only progress to uremia and need renal replace treatment, it also significantly increases risk of cardiovascular disease than non-ckd population. it has created a heavy burden on people's health and national economy. there is an urgent need to establish an effective system for ckd prevention and control in china. evidences from large sample cohort and real world based research are still rare. this study will provide good experience for reducing the occurrence and development of ckd.

this study is designed as an investigator-initiated, multi-center, prospective and observational real world study based on mainland chinese population. the investigators aimed to investigate the occurrence, development, treatment, prognosis state and related risk factors of ckd in china. this study based on the standardized data network, which provides efficient data collection, integration and analysis for researchers and clinicians in multi-centers. the sample size of this study was estimated by statisticians, epidemiologists and clinicians. real-world studies adopted an open standard for inclusion and exclusion, larger sample size could cover a wider group of patients and take the possibility of loss of follow-up into account. subgroup analysis can be performed in a heterogeneous population and expand the significance of the study.

Eligibility criteria:
inclusion criteria: * patients diagnosed with ckd as defined in the kdigo clinical practice guidelines for the evaluation and management of chronic kidney disease 2012 edition; * non-ckd patients with hypertension, diabetes, hyperlipidemia, hyperuricemia, egfr (ckd-epi formula) of 60-89 ml/min/1.73m\^2 and other risk factors for ckd; * healthy population. * signed the informed consent voluntarily. exclusion criteria: 。patients identified to be unsuitable for enrollment by the study physician.

Keywords: chronic kidney disease
special investigation of kaletra in pregnant women

Conditions: Human Immunodeficiency Virus

Summary: this non-interventional, post-marketing observational study was conducted to obtain safety data from the use of lopinavir/ritonavir (kaletra), in clinical practice, in pregnant women and their children in japan.


Eligibility criteria:
inclusion criteria: * all pregnant women who have received kaletra for the treatment of hiv infection were eligible for this study exclusion criteria: * contraindications according to the package insert: * patients with a history of hypersensitivity to any ingredient of kaletra * patients who are receiving pimozide, cisapride, ergotamine tartrate, dihydroergotamine mesylate, ergometrine maleate, methylergometrine maleate, midazolam, triazolam, vardenafil hydrochloride hydrate, boriconazol

Keywords: human immunodeficiency virus
hybrid device dialytrode for multimodal neuro-monitoring of patients with brain injury and status epilepticus

Conditions: Epilepsy; Brain Injuries

Summary: this clinical trial evaluates the safety and diagnostic performance of a newly developed combined catheter that will be implanted into the brain of patients with severe brain injury for short time (up to 28 days) monitoring of the electric activity and the metabolism of brain tissue at risk. ten patients will be monitored with the new device and seven patients will be monitored by intracerebral probes according to standard treatment.

early detection of nonconvulsive status epilepticus (ncse) in patients treated in neurological intensive care unit (nicu) is essential, as delayed treatment can aggravate their clinical situation and worsen the outcome. in this study in intensive care patients with severe brain injury due to malignant middle cerebral artery (mca) infarction, subarachnoidal hemorrhage (sah) or intracerebral hemorrhage (ich) with suspected status epilepticus in the surface eeg the hybrid catheter dialytrode will be implanted in the cortical brain tissue by neurosurgeons for short time continuous bedside multimodal neuro-monitoring. dialytrode combines a microdialysis catheter and depth eeg probe. ten subjects will be monitored by dialytrode and an additional (intracranial pressure (icp) probe. subjects with an clinical indication of an external ventricular drain (evd) or cerebral microdialysis alone serve as control. the monitoring period with the device is limited to the microdialysis phase with a maximum of 28 days. subjects will be followed up for 7 days after end of intracerebral monitoring.

Eligibility criteria:
inclusion criteria: 1. clinical condition requiring treatment in nicu 2. mca or subarachnoidal haemorrhage (sah) or intracerebral haemorrhage (ich) 3. given indication of evd with or without multimodal monitoring by micro-dialysis or given indication of multimodal monitoring by micro-dialysis and continuous depth eeg-monitoring due to (a) suspected se in surface eeg (e.g. rhythmic pattern) or (b) refractory status epilepticus (rse) in surface eeg or (c) an unclear situation of not waking up even though sedation is reduced or suspected se without acute brain injury exclusion criteria (main criteria): * subject receiving anticoagulants in therapeutic dose * bleeding disorder * known contraindications for eeg depth electrodes or microdialysis probes * presence of an infectious lesion of skin (limited to the scalp) * presence of general contraindications for any surgical intervention * sepsis or acute severe bacterial infection * fragile bones of the skull * severe organ failure or medical conditions displaying a contraindication for participating * pregnant or nursing woman

Keywords: epilepsy multimodal neuromonitoring depth eeg microdialysis brain injury brain tissue at risk ncse short time monitoring neurologic icu
efficacy and safety of turoctocog alfa for prophylaxis and treatment of bleeding episodes in previously treated chinese patients with haemophilia a

Conditions: Congenital Bleeding Disorder; Haemophilia A

Summary: this trial is conducted in china. the aim of this trial is to evaluate the clinical efficacy of turoctocog alfa in treatment of bleeding episodes in chinese patients with severe haemophilia a (fviii≤1%).


Eligibility criteria:
inclusion criteria: * male patients * age from 0 years * with the diagnosis of severe congenital haemophilia a (fviii≤1%) * history of exposure days (ed) to any fviii products fulfilling the criteria of previously treated patients: * patients of 12 years or above: 100 exposures days (ed) or more * patients below 12 years: 50 exposure days (ed) or more exclusion criteria: * inhibitors to factor viii (≥0.6 bu) at screening as assessed by central laboratory * known history of fviii inhibitors
mrx-800: a long-term safety study of maralixibat in the treatment of cholestatic liver disease in subjects who previously participated in a maralixibat study

Conditions: Cholestatic Liver Disease

Summary: evaluate the long-term safety of maralixibat (mrx) in subjects with cholestatic liver disease including, but not limited to, alagille syndrome (algs), progressive familial intrahepatic cholestasis (pfic) and biliary atresia.

this is a multicenter, open-label study of maralixibat in subjects diagnosed with cholestatic liver disease (including, but not limited to algs, pfic or biliary atresia) who have previously participated in a maralixibat clinical study. all subjects will receive maralixibat in this study.

Eligibility criteria:
inclusion criteria subjects will need to meet all criteria below to be considered eligible for the study. 1. provide informed consent and assent (as applicable) per the institutional review board/ethics committee (irb/ec). 2. previously participated in a maralixibat study and with approval of the medical monitor. previous participation is defined as: * having completed the eot visit, for subjects coming from the maralixibat phase 2 studies. * having completed the entire duration of the study (i.e., core and extension, if applicable), for subjects coming from the maralixibat phase 3 studies. 3. at least 1 year of age 4. males, and females of non-childbearing potential. males and non-pregnant, non-lactating females of childbearing potential who are sexually active must agree to use acceptable contraception during the study and 30 days following the last dose of the study medication. females of childbearing potential must have a negative pregnancy test. 5. caregivers (and/or age appropriate subjects) must have access to email or phone for scheduled remote visits if applicable. 6. subject and caregiver willingness to comply with all study visits and requirements. exclusion criteria a subject will be excluded from the study if any of the following exclusion criteria are met: 1. experienced an ae or sae related to maralixibat during the lead-in protocol that led to permanent discontinuation of the subject from maralixibat. 2. any conditions or abnormalities (including laboratory abnormalities) which, in the opinion of the investigator or medical monitor may compromise the safety of the subject or interfere with the subject participating in or completing the study. 3. history of non-adherence to medical regimens, unreliability, medical condition, mental instability or cognitive impairment that, in the opinion of the investigator or sponsor medical monitor, could compromise the validity of informed consent, compromise the safety of the subject, or lead to non-adherence with the study protocol or inability to conduct the study procedures.

Keywords: pfic algs maralixibat bile duct diseases liver diseases biliary tract diseases digestive system diseases pediatric
an effectiveness trial of project alert

Conditions: Alcohol Drinking; Smoking; Marijuana Smoking

Summary: the purpose of this study is to replicate a longitudinal evaluation of project alert, a substance abuse prevention program that targets middle school students.

project alert is a substance abuse prevention program that targets middle school students. the purposes of this evaluation are to test its immediate and one-year effectiveness in a randomized experimental design that will span a total of 2.5 years for each of two cohorts. the cohorts are spaced one year apart to reduce our implementation and data collection burdens at any one time. the design for the two cohorts is identical. in schools randomly assigned to the treatment group, instructors receive project alert training and materials prior to beginning the program and have access to technical assistance on request. in schools randomly assigned to the control group, teachers implement whatever substance abuse prevention curricula they normally would (if any).

Eligibility criteria:
inclusion criteria: * schools with 6th-8th grades housed together on a common campus * schools with 6th grade student population of at least 100 students * schools with no current 6th, 7th, or 8th grade implementation of any drug prevention curriculum recognized as a model program by a federally-sponsored registry * all regular education students in the targeted grade must participate exclusion criteria: * students in self-contained classrooms (i.e., special education classes)

Keywords: smoking alcohol prevention prevention & control
a safety and tolerability study of abt-089 in children with attention-deficit/hyperactivity disorder (adhd)

Conditions: Attention-Deficit/Hyperactivity Disorder

Summary: the objective of this study is to evaluate the long-term safety and tolerability of abt-089 in children with adhd.


Eligibility criteria:
inclusion criteria: * the subject was randomized into base study (m06-888 or m10-345) and completed the treatment period. * if female, subject must be practicing at least one method of birth control throughout the study. * if female, the result of a pregnancy test is negative. * the subject is judged to be in generally good health. exclusion criteria: * the subject experienced a serious adverse event in base study (m06-888 or m10-345) that the investigator considered "possibly" or "probably related" to study drug. * the subject has taken any adhd medication between the last dose of study drug in study m06-888 or m10-345 and the first dose of study drug in the current study. * the subject has a positive urine drug screen for alcohol or drugs of abuse. * the subject anticipates a move outside the geographic area.
clinical study of khk7791 in hyperphosphatemia patients on peritoneal dialysis

Conditions: Hyperphosphatemia

Summary: to evaluate the efficacy of khk7791 by comparing changes in serum phosphorus levels from baseline values between peritoneal dialysis patients with hyperphosphatemia receiving repeated administration of khk7791 for 8 weeks and those receiving placebo.


Eligibility criteria:
inclusion criteria: 1. has voluntarily provided written informed consent to participate in the study. 2. aged ≥ 20 years (expressed in completed years) at the time of providing informed consent. 3. stable chronic renal failure patients who have undergone peritoneal dialysis 3 times per week for at least 12 weeks until screening examination. 4. dialysis conditions, should have been unchanged during the last 2 weeks before screening examination. 5. the prescribed drug and dosage regimen should have been unchanged during the last 2 weeks before screening examination. 6. serum phosphorus levels should be in the range of ≥ 3.5 and ≤ 7.0 mg/dl at screening examination. 7. if on any vitamin d, calcimimetics regimen, bisphosphonate,calcitonin preparations, selective estrogen receptor modulators or teriparatide preparations then the prescribed drug and dosage regimen should have been unchanged for the last 4 weeks before screening examination. exclusion criteria: 1. subjects who received concomitant hemodialysis or hemodialysis filtration within 12 weeks before screening examination. 2. having concurrent or a history of inflammatory bowel disease (ibd) or diarrhea-predominant irritable bowel syndrome 3. history of gastrectomy or enterectomy or having undergone gastrointestinal tract surgery within 3 months before screening examination. 4. subjects in whom peritonitis, catheter-related infections, catheter dysfunction, etc. are confirmed within 4 weeks before screening examination., and the continuation of peritoneal dialysis is considered to be interfering with the implementation of peritoneal dialysis. 5. subjects who used anti rankl preparations within 6 weeks before screening examination. 6. subjects who used anti-sclerostin antibody preparations within 12 weeks before screening examination. 7. having concurrent severe heart disease or hepatic impairment. 8. developed cerebrovascular disease or cardiovascular disease requiring hospitalization within 6 months before screening examination. 9. subjects who have undergone parathyroid intervention within 24 weeks before screening examination., or subjects who are scheduled to undergo parathyroid intervention between the implementation of the pretest and the completion of the study. 10. uncontrollable hypertension or diabetes. 11. scheduled for living donor kidney transplant, change in the mode of dialysis, home hemodialysis, or change in the dialysis center (relocate to another hospital/clinic) during the study period. 12. any diagnosis of and treatment of malignancy within 5 years before screening examination.

Keywords: tenapanor hyperphosphatemia peritoneal dialysis