Kornimate/medical-research-clean huggingface dataset:
financial and clinical impact of repeal of the pennsylvania motorcycle helmet law

Conditions: Craniocerebral Trauma; Facial Injuries

Summary: the purpose of this study is to find out how many helmeted versus non-helmeted motorcycle accident victims (mca) sustain head and/or face injuries. also, we will find out how much it costs to get medical care for head and face injuries in helmeted versus non-helmeted motorcycle victims. finally, we will compare how long it takes helmeted versus non-helmeted motorcycle victims with face and head injuries to return to work.

this is a prospective, quasi-experimental research study that will compare clinical outcomes of helmeted versus non-helmeted motorcycle victims admitted to trauma centers, as well as victims treated and released from emergency departments. the primary objective of this study is: * to determine if the financial charges and ratio of cost to charges (rcc), including acute hospitalization, rehabilitation or skilled care, outpatient care, and time to return to work (implying lost wages) is different between helmeted versus non-helmeted motorcyclists with head or face injuries secondary objectives include: * to determine if inpatient mean total acute care and downstream charges and rcc are higher for non-helmeted versus helmeted motorcycle victims admitted to three pennsylvania trauma centers with head and face injuries * to determine the mean time of return to full duty work (at previous level of employment) is shorter for helmeted or non-helmeted motorcycle victims admitted to three pennsylvania trauma centers with head and face injuries * to determine if non-helmeted or helmeted motorcycle victims admitted to three pennsylvania trauma centers have increased incidence and severity of head and face injuries * to determine the incidence and severity of non-helmeted motorcycle accident victims is higher than helmeted counterparts treated and released from emergency departments for face and head injuries * to determine if non-helmeted motorcycle victims die at scene or in emergency departments (from head and face injuries) more often than helmeted motorcycle victims * to determine if more helmeted or non-helmeted motorcycle accident victims require no immediate medical care for head and face injuries

Eligibility criteria:
inclusion criteria: * all english speaking drivers/passengers of motorcycle accidents, 18 years or older, with head or face injuries served by participating study trauma centers, emergency departments or coroners. * all english speaking drivers/passengers of motorcycle accidents, 18 years of age or older, served by pennsylvania police but did not require acute medical services. exclusion criteria: * non-english speaking * served by trauma center, emergency department or coroner, but without haed or face injury * less than 18 years of age * moped accidents * motorized bicycle accidents * parked motorcycle accidents * off road motorcycle accidents, not on a public street or highway * dirtbike or motorcross accidents, involving vehicles not licensed for highway use

Keywords: motorcycle accident helmet traumatic brain injury financial burden
tranexamic acid to reduce infection after gastrointestinal surgery

Conditions: Infection Wound; Gastrointestinal Complication; Anesthesia; Bleeding; Healthcare Associated Infection

Summary: this international, multicentre, pragmatic, double-blind, placebo-controlled, randomised trial of txa versus placebo will enrol 3,300 patients throughout australia and internationally. this is an effectiveness trial - some elements of the trial are deliberately left to the perioperative clinicians' discretion in order to reflect usual practice and maximise generalisability.

study aims: to conduct a large, multicentre clinical trial of tranexamic acid (txa), an antifibrinolytic drug routinely used to reduce bleeding in cardiac and some orthopaedic surgery, in 3,300 patients undergoing major gastrointestinal (gi) surgery. our specific aims are to investigate whether txa: aim 1: reduces surgical site infection ("wound infection"), and other healthcare-associated infections (pneumonia and sepsis). aim 2: reduces red cell transfusion in gi surgery. aim 3: reduces a pooled composite of any serious postoperative complications, and so increases "days alive and at home up to 30 days after surgery" (dah30). aim 4: to evaluate the temporal effect of txa on perioperative immune and inflammatory responses. study hypothesis prophylactic txa administration in patients undergoing major gi surgery reduces the incidence of surgical site infection (ssi) after surgery when compared with placebo.

Eligibility criteria:
inclusion criteria: 1. adult patients scheduled for elective or semi-elective (inpatient) open or lap-assisted gi surgery (oesophageal, gastric, hepatobiliary, colorectal) with one or more risk factors for complications: * age ≥70 years * asa physical status 3 or 4 * known or suspected history of: heart failure, diabetes, peripheral vascular disease, or chronic respiratory disease * obesity (bmi ≥30 kg/m2) * anaemia (preoperative haemoglobin \<130 g/l in males and \<120 g/l in females) * renal impairment (se. creatinine ≥150mol/l) * low albumin (\<30 g/l) exclusion criteria: * poor spoken and or written language comprehension * laparoscopic cholecystectomy and other minor (eg. closure of stoma) surgery * pre-existing infection/sepsis * known history of: spontaneous pulmonary embolism, arterial thrombosis familial thrombophilia (e.g. lupus anticoagulant, protein c deficiency, factor v leiden)
blood flow restriction training in patients with lower extremity fractures

Conditions: Tibial Fractures; Lower Extremity Fracture

Summary: this study will look at the effect of using a blood flow restriction device during low load strengthening exercises on patients with tibial shaft fractures, compared to patients performing exercise without the device. the study will compare muscle strength, muscle size, fracture healing, and return to normal function between the two groups.

this study will examine the effect of blood flow restriction (bfr) training in patients with lower extremity fractures. patients with tibial shaft fractures will be assigned to either the bfr group or control group. the bfr group will perform exercises with a blood flow restriction device, which occludes venous blood flow in the limb, while performing strengthening exercises as directed by a doctor of physical therapy. the control group will perform the exercises without the device, as is current standard practice in physical therapy. blood flow restriction training has been shown to prevent strength loss and muscle atrophy after surgery or injury, and studies suggest that it increases biomarkers of bone metabolism and tissue healing. the goal of this study is to examine the use of bfr in trauma patients using a defined protocol, and compare fracture healing, muscle strength, muscle girth, and subjective physical function between groups.

Eligibility criteria:
inclusion criteria: * adult with closed tibial shaft fracture * ability to begin physical therapy treatment within 2 weeks post-operatively exclusion criteria: * history of osteoporosis or osteopenia * impaired circulation in the limb * active deep vein thrombosis * clotting disorders or other elevated risk of embolism * sickle cell anemia * infection in extremity * renal compromise * severe uncontrolled hypertension (sbp\>180) * lymphedema * under age 18 * pregnancy * prisoner
effects of laugh-yoga intervention on mood and quality of life among oncologic patients in a oncologic clinic setting.

Conditions: Neoplasms

Summary: previous studies report low levels of mood and of quality of life among cancer patients. laugh has been proved to improve mood and immune system function. the investigators propose to assess in a prospective randomised case-control study the affects of laugh-yoga intervention on mood levels and quality of life among cancer patients in a cancer clinic. the main hypothesis is that patients in laugh-yoga group will report higher mood and quality o life levels after intervention in comparison with no-intervention group. the second hypothesis is that immune system is the mediator of the effects of laugh-yoga intervention on mood and quality of life.


Eligibility criteria:
inclusion criteria: * oncologic patients treated in oncologic clinic in wolfson mc, * must be able to participate in laugh yoga session exclusion criteria: * psychiatric or cognitive impairment, * deterioration in physical status, * treatment discontinuation

Keywords: neoplasm laugh-yoga mood quality of life
photodynamic therapy in treating patients with early esophageal cancer

Conditions: Esophageal Cancer

Summary: rationale: photodynamic therapy uses light and drugs that make cancer cells more sensitive to light to kill tumor cells. this may be an effective treatment for esophageal cancer. purpose: phase ii trial to study the effectiveness of photodynamic therapy in treating patients with barrett's esophagus who have in situ esophageal cancer.

objectives: i. evaluate the efficacy of photodynamic therapy (pdt) using porfimer sodium (photofrin) and controlled uniform laser light in patients with carcinoma in situ in barrett's esophagus or severe dysplasia in barrett's esophagus. ii. evaluate the safety of the treatment on this patient. outline: this is a noncomparative study. pdt consists of iv porfimer sodium followed 40-50 hours later by laser red light delivered by optic fibers passed through the biopsy channel of an endoscope. retreatment, if necessary, consists of up to 3 injections at least 30 days apart and up to 6 laser light treatments, with a maximum of 2 following each injection. patients are followed monthly for 4 months, and then periodically for at least 5 years. projected accrual: a total of 20 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: histologically confirmed primary, stage 0 carcinoma in situ (cis) in conjunction with barrett's esophagus or severe dysplasia in barrett's esophagus who are medically unsuitable for or have refused surgery previously biopsied barrett's mucosa with areas of severe dysplasia and/or cis patient characteristics: age: 18 and over performance status: karnofsky greater than 50% life expectancy: not specified hematopoietic: wbc at least 2,000/mm3 platelet count at least 50,000/mm3 hepatic: no porphyria or hypersensitivity to porphyrins bilirubin no greater than 3.0 mg/dl alkaline phosphatase no greater than 3 times uln sgot no greater than 3 times uln pt no greater than 1.5 times the upper limit of normal (uln) renal: creatinine no greater than 3.0 mg/dl other: no contraindication to endoscopy not pregnant or nursing fertile patients must use effective contraception prior concurrent therapy: biologic therapy: not specified chemotherapy: no concurrent chemotherapy at least 1 month since prior chemotherapy endocrine therapy: not specified radiotherapy: no concurrent radiation therapy no concurrent laser therapy at least 1 month since prior radiation therapy at least 1 month since prior laser therapy surgery: not specified

Keywords: stage 0 esophageal cancer
multicenter, open, prospective, 48 weeks, observational study ,evaluate the safety and efficacy of nephoxil capsule

Conditions: Hyperphosphatemia

Summary: the purpose of this study is to evaluate the safety and efficacy of nephoxil capsule administration for the improvement of hyperphosphatemia in ckd patients undergoing hemodialysis under actual conditions of routine medical care.

this study is a prospective observational study, and only observable information is collected during visits 1 to 13 of the subjects' routine outpatient visits. therefore, no further visits related to this study are planned, and all treatments, examinations, and evaluations necessary for the subjects shall be conducted at the discretion of the investigator. the initial dose of nephoxil capsules for the subjects participating in this study shall be determined at the investigator's discretion, and subjects shall be classified into either the low-dose group (1.5 g/day) or the standard-dose group (4 g/day) according to the initial dose. during the observation period, dose titration within 1 g may be performed at the investigator's discretion, and in such cases, the maximum dose per day shall not exceed 6 g.

Eligibility criteria:
inclusion criteria: 1. adults 19 years of age or older as of the icf date 2. ckd patients undergoing hemodialysis to whom nephoxil capsule shall be administered for the first time for the treatment of hyperphosphatemia as per the determination of the investigator 3. patients who voluntarily decide to participate in this study and complete the icf exclusion criteria: 1. those who fall under the "do not administer to the following patients" criteria according to nephoxil capsule indication approval 2. those who require concomitant administration of aluminum-containing medication 3. others determined by the investigator to be unsuitable for participation in this study
comparison of laparoscopic versus open gastrectomy for advanced gastric cancer:a prospective randomized trial

Conditions: Stomach Neoplasm; Laparoscopy; Gastrectomy; Complications

Summary: the purpose of this study is to compare the short- and long-term results between the laparoscopy-assisted gastrectomy and the open gastrectomy.

background: the use of laparoscopic surgery in the management of advanced gastric cancer (agc) has not yet met with widespread acceptance and remains limited to only a few centers. intervention: according to tumor pathological stage (jgca, 2nd english ed), location of tumor, and patient clinical condition, a laparoscopy-assisted radical gastrectomy and open gastrectomy were performed. laparoscopy-assisted radical gastrectomy consisted of the following procedures: 1) laparoscopic dissection of the lesser and greater omentum, ligation and division of the main vessels to mobilize the stomach under pneumoperitoneum, 2) laparoscopic d2 lymph node dissection, based on the guidelines of the japan gastric cancer association and 3) resection of the distal two thirds (ladg), proximal third (lapg), or total stomach (latg), depending on the location of the tumor, followed by reconstruction by the billroth i, billroth ⅱ, esophagogastrostomy, or roux-en-y method through a 3 to 5-cm-long minilaparotomy incision. follow-up schedule: all patients were monitored postoperatively by physical examination, and blood tests including a test for serum carcinoembryonic antigen (cea) at least every three months for the ﬁrst year, every six months for the next two years, and every year for the fourth and fifth year, and thereafter by abdominal ultrasonography, ct, chest radiography, and gastroscopy at least once each year.

Eligibility criteria:
inclusion criteria: 1. pathologically proven gastric adenocarcinoma 2. age:older than 18 years old,younger than 80 years old 3. preoperative stage(ct, gfs stage):ct2n0m0, ct2n1m0, ct2n2m0, ct3n0m0, ct3n1m0,ct3n2m0 4. asa score:≤3 5. patients with an invasion of the gastric serosa exceeding 10 cm2 according to ultrasound examination or examination during surgery were excluded 6. no history of other cancer 7. no history of chemotherapy or radiotherapy 8. written informed consent exclusion criteria: 1. concurrent cancer patients or patient who was treated due to other types of cancer before the patient was diagnosed as a gastric cancer patient 2. patient who was treated by other types of treatment methods, such as chemotherapy, immunotherapy, or radiotherapy 3. patient who was received upper abdominal surgery (except, laparoscopic cholecystectomy) 4. asa score:\>3 5. contraindication of laparoscopy: severe cardiac disease, abdominal wall hernias, diaphragmatic hernias, uncorrected coagulopathies, portal hypertension, pregnancy 6. complicated case needed to get emergency operation 7. any accompanying surgical condition needed to be performed in same time

Keywords: stomach neoplasm laparoscopy gastrectomy
assessment of device for treatment of amblyopia

Conditions: Amblyopia

Summary: the study will evaluate the effect of reviview™, a dichoptic video display device for administrating a novel treatment protocol for amblyopia (lazy eye) in kids. the effect of the treatment will be measured by the change from baseline in visual acuity and in stereoscopic vision; and to assess the ease of use of and compliance by the patients.


Eligibility criteria:
inclusion criteria: refractive or strabismic amblyopia, with best corrected visual acuity. (1) refractive amblyopia, visual acuity score \<6:15 (worse then) * or (2) strabismic amblyopia, visual acuity score between 6:15 and 6:30 exclusion criteria: diagnosed with epilepsy, recently treated with occlusion or penalization therapy

Keywords: amblyopia
an investigation into the efficacy of herpecin l at reducing the frequency and severity of cold sores

Conditions: Cold Sores

Summary: focus consumer healthcare has developed herpecin l. herpecin l combines many different ingredients hypothesized to promote quick healing and symptom reduction from cold sores.


Eligibility criteria:
inclusion criteria: * male female between 18-60 years of age. * must be in good health with no significant chronic conditions and a bmi under 35. * must experience regular cold sores or fever blisters * must agree to avoid daily lip balm or another product designed to alleviate their cold sore (e.g., abreva or other over-the-counter cold sore products). exclusion criteria: * suffers from pre-existing conditions that would prevent them from adhering to the protocol including chronic conditions such as oncological or psychiatric disorders. * anyone with known severe allergic reactions. * unwilling to follow the study protocol. * currently pregnant, breastfeeding, or wanting to become pregnant for the duration of the study.
effect of sedation on diagnostic injections

Conditions: Sacroiliac Joint Pain; Sympathetically Maintained Pain

Summary: interventional pain procedures have diagnostic, prognostic and therapeutic value. it is well-documented that the reference standard for identifying a pain generator is a low-volume block performed with local anesthetic, with or without steroid. many factors may increase the false positive (fp) rate of diagnostic and prognostic nerve blocks; however, the use of sedation is the most controversial and remediable. proponents of sedation argue that it has little effect on the rate of positive diagnostic blocks, and may even reduce the false-negative rate. the purpose of this study is to determine the effect of intravenous sedation on pain relief and the "false-positive rate" after diagnostic nerve blocks.

sixty-eight patients with sacroiliac (si) joint or sympathetically-maintained pain will be randomized in a crossover fashion to receive diagnostic nerve blocks either with or without intravenous sedation. among those who obtain some benefit and return for a 2nd block, this 2nd procedure will be done with sedation if the first was done without sedation, and vice versa. midazolam and fentanyl will be used for intravenous sedation, titrated to anxiolysis and analgesia. pain scores (0-10 numerical rating scale, or nrs) and an activity log will be recorded over the 8-hours following the blocks via a pain diary. the first follow-up visit will be 4 weeks after the procedure. patients who obtain some benefit but continue to report significant pain or who might otherwise benefit from a repeat procedure will have this second procedure performed with sedation if no sedation was given for the first procedure, and without sedation if sedation was administered for the first procedure. the post-procedure pain data will be recorded in the same fashion as the initial nerve block. the second follow-up visit will be 4 weeks after the 2nd block.

Eligibility criteria:
inclusion criteria: * chronic pain \> 4 weeks but \< 10 years in duration * suspected si joint or sympathetically-maintained pain based on history and physical exam * may benefit from a sacroiliac joint or sympathetic block * pain on 0-10 nrs scale \> 3/10 in intensity exclusion criteria: * no previous interventional pain-alleviating injections for the same condition within the past 3 years * uncontrolled coagulopathy * pregnancy, which will be ruled out by a urine pregnancy test in women of childbearing age * allergy to contrast dye or amide local anesthetics * unstable medical or psychiatric condition (e.g. unstable angina, congestive heart failure or severe depression) that could preclude an optimal treatment response * systemic infection * age \ 75 years

Keywords: sedation sensitivity specificity validity diagnostic injection
safety and efficacy study of tozadenant to treat end of dose wearing off in parkinson's patients

Conditions: Idiopathic Parkinson's Disease

Summary: phase 3, international, multicenter, randomized, double-blind, placebo-controlled, parallel-group, 3-arm safety and efficacy study (part a) with an open-label phase (part b).

during part a, each patient will participate for up to 30 weeks, which includes a screening period of 1 to ≤ 6 weeks, followed by a baseline visit and 24 weeks of double-blind treatment: * screening period: 1 - 6 weeks. * double-blind treatment period: 24 weeks. after completion of part a, patients will continue in part b for an additional 56 weeks: * open-label treatment period: 52 weeks. * post-treatment safety follow up: 4 weeks.

Eligibility criteria:
inclusion criteria: * patient understands study requirements and has given his/her written informed consent on an institutional review board (irb) or independent ethics committee (iec) approved consent form. * parkinson's disease diagnosis consistent with uk parkinson's disease society brain bank diagnostic criteria * minimum of 3 years since diagnosis. * meet hoehn and yahr pd stage * good response to levodopa * stable regimen of anti-pd medications * patients must have been taking a levodopa-containing anti-pd medication continuously for at least the previous 12 months * patient has documented a minimum amount of off time. * if of childbearing potential (male and female) must use an acceptable method of contraception exclusion criteria: * previous tozadenant study participation * current or recent participation in another study. * secondary or atypical parkinsonism * neurosurgical intervention for pd * patient is taking apomorphine, budipine, istradefylline, tolcapone, or duopa™/duodopa® * treatment with excluded medications * untreated or uncontrolled hyperthyroidism or hypothyroidism * clinically significant out-of-range laboratory * mmse out of range * current episode of major depression (stable treatment for depression is permitted). * recent suicide attempt or suicidal ideation type 4 or type 5 of the columbia-suicide severity rating scale (c-ssrs) * women lactating or pregnant * hypersensitivity to any components of tozadenant or excipients * abnormal findings on the physical or neurological examination, or medical history that would make the patient unsuitable for the study * history of hepatitis or cholangitis

Keywords: motor fluctuations off time on time dyskinesia