Kornimate/medical-research-clean huggingface dataset:
comparing two treatment modalities of peri-implantitis - blue laser (445 nm) and conventional flap surgery

Conditions: Peri-Implantitis

Summary: a clinical trial comparing laser treatment and conventional mucosal flap surgery for treatment of peri-implantitis. the main aim of the study is to evaluate if treatment of peri-implantitis with a novel blue laser (445 nm) combined with scaling and root planning (srp) is clinically comparable to conventional mucosal flap surgery in terms of pocket probing depth reduction.

the present project aims to evaluate a novel method in treating peri-implantitis, with focus on decreasing the patient's suffering as well as disease progression. peri-implantitis has a direct influence on both physical and psychological well-being and have been related to difficulty in chewing due to loss of implants, bad esthetic appearance as well as high costs. therefore, it is of importance for the individual as well as for the society to thoroughly investigate any new treatment approaches. the study is a prospective randomized clinical trial comparing laser treatment (test group) and conventional mucosal flap surgery (active control group). assessment of clinical variables at baseline and after 6 months. patient reported outcomes at baseline, directly after treatment and after 10 days. primary objective: to evaluate if treatment of peri-implantitis with a novel blue laser (445 nm) combined with scaling and root planning (srp) is clinically comparable to conventional mucosal flap surgery in terms of pocket probing depth reduction. secondary objectives: * to evaluate other clinical and radiological variables connected to peri-implantitis and the inflammation surrounding the dental implant. * to evaluate the patient experience of a novel blue laser for treatment of peri-implantitis. * to evaluate the inflammatory and microbial response after laser treatment

Eligibility criteria:
inclusion criteria: * signs of peri-implantitis around one or more dental implants. all criteria below need to be fulfilled for inclusion. * presence of pocket probing depth (ppd) \> 5 mm * bleeding on probing/suppuration (bop/pus) * at least 2 mm loss of bone, visible on radiographs, after initial osseointegration. * ≥ 18 years old. * patient able to understand swedish. exclusion criteria: * antibiotic treatment 6 months prior to baseline. * peri-implant treatment 6 months prior to baseline. * myocardial infarction 6 months prior to baseline. * previous radiation treatment in the affected jaw area. * previous i.v. bisphosphonate treatment. * moderate or severe impairment of cognitive function (e.g. dementia).

Keywords: laser treatment surgical treatment patient reported outcomes microbiology immunology radiological examination
annexin a5 in patients with severe covid-19 disease

Conditions: Coronavirus Infection; Sepsis

Summary: randomized, double-blind, placebo-controlled trial comparing 2 doses of sy-005 (recombinant human annexin a5) to placebo in patients with severe coronavirus 2019 disease in a single hospital centre with 2 intensive care units


Eligibility criteria:
inclusion criteria: 1. age ≥ 19 years 2. positive test for sars-cov-2 virus (anytime during current illness episode) 3. admitted to intensive care for organ failure support (at least one of vasopressor, non-invasive or invasive ventilation) exclusion criteria: 1. known allergy to any of the ingredients or components of the investigational product 2. known pregnancy 3. moribund and not expected to survive beyond 24 hours 4. known or suspected risk for serious bleeding complications (note that disseminated intravascular coagulopathy (dic) is an expected finding in patient with sepsis and covid-19 disease and is not an exclusion criterion on its own) 5. acute or chronic renal failure (dialysis dependent)
phase 3 study to evaluate the efficacy & safety of tralokinumab in adults & adolescents with ocs dependent asthma

Conditions: Asthma

Summary: a multicentre, randomized, double-blind, parallel group, placebo controlled, phase 3 study to evaluate the efficacy and safety of tralokinumab in reducing oral corticosteroid dependent asthma.

this is a randomized, double-blind, parallel group, placebo-controlled study designed to evaluate the efficacy and safety of a fixed 300 mg dose of tralokinumab administered subcutaneously every 2 weeks in adult and adolescent subjects with oral corticosteroid dependent asthma. approximately120 subjects will be randomized globally. subjects will receive tralokinumab or placebo, administered via subcutaneous injection at the study site, over a 40-week treatment period.

Eligibility criteria:
inclusion criteria: 1) age 12-75 2) documented physician-diagnosed asthma. 3) documented treatment with ics at a total daily dose corresponding to ≥500µg fluticasone propionate dry powder formulation and a laba. 4) subjects must have received ocs for the treatment of asthma for 6 months prior to visit 1 and on a stable ocs dose between ≥7.5 to ≤30mg daily or daily equivalent for at least one month prior to enrolment (visit 1) . 5) pre-bd fev1 value \<80% (\<90% for patients 12-17 yrs of age) of their pnv. 6) post-bd reversibility of ≥12% in fev1. exclusion criteria: 1) clinically important pulmonary disease other than asthma. 2) history of anaphylaxis following any biologic therapy. 3) hepatitis b, c or hiv. 4) pregnant or breastfeeding. 5) history of cancer. 6) current tobacco smoking or a history of tobacco smoking for ≥10 pack-years. 7) previous receipt of tralokinumab.

Keywords: asthma reactive airways repiratory tract disease obstructive lung disease lung diseases
safety and efficacy of sofosbuvir-based regimens in the treatment of egyptian patients with hepatitis c infection

Conditions: Hepatitis C

Summary: egypt has the highest prevalence of hepatitis c virus (hcv) in the world, estimated nationally at 14.7%. genotype 4 (and subtype 4a in particular) dominates the hcv epidemic in egypt. for decades the antiviral therapy of chronic hcv infection was based on the administration of interferon(ifn), initially alone and then in combination with ribavirin (rbv), but this regimen was effective in only 50% of patients with genotype 1, with significant side effects.

egypt has the highest prevalence of hepatitis c virus (hcv) in the world, estimated nationally at 14.7%. genotype 4 (and subtype 4a in particular) dominates the hcv epidemic in egypt. for decades the antiviral therapy of chronic hcv infection was based on the administration ofinterferon(ifn), initially alone and then in combination with ribavirin (rbv), but this regimen was effective in only 50% of patients with genotype 1, with significant side effects. the introduction of direct acting antiviral agents, in particular sofosbuvir (sof), has revolutionized the treatment for chronic hepatitis c virus.

Eligibility criteria:
inclusion criteria: * • hcv infection * adult patients, 18years and older. exclusion criteria: * • child score \> 12 * severe renal impairment * pregnant and lactating women * hcc or other malignant neoplasms * co-infection with human immunodeficiency virus (hiv) * co-infection with hepatitis b virus (hbv)
90% effective dose of norepinephrine infusions under intensive and standard treatment in preeclamptic patients

Conditions: Adverse Effect

Summary: the objective of this study is to investigate the 90% effective dose of norepinephrine infusions for preventing postspinal anesthesia hypotension under intensive and standard treatment in preeclamptic patients during cesarean section

post-spinal anesthesia hypotension is a frequent complication during spinal anesthesia for cesarean section. the incidence of post-spinal anesthesia hypotension is as high as 62.1-89.7% if prophylactic measures are not taken. the 2016 asa guidelines for obstetric anesthesia suggest avoiding hypotension following spinal anesthesia in women and emphasize the use of vasopressors, specifically alpha-receptor agonists, as the preferred strategy to prevent and manage post-spinal anesthesia hypotension. the 2018 international consensus in the united kingdom and northern ireland recommends maintaining maternal systolic blood pressure above 90% of the baseline value following lumbar anesthesia, while avoiding dropping below 80% of the baseline value. currently, the threshold for maintaining blood pressure above 80% of the baseline value is widely adopted as a standard; however, limited evidence supports the advantage of sustaining maternal blood pressure above 90% of the baseline value. the objective of this study is to investigate the 90% effective dose of norepinephrine infusions for preventing postspinal anesthesia hypotension under intensive and standard treatment in preeclamptic patients during cesarean section.

Eligibility criteria:
inclusion criteria: * 18-45 years * primipara or multipara * singleton pregnancy ≥32 weeks * american society of anesthesiologists physical status classification i to iii * scheduled for cesarean section under spinal anesthesia exclusion criteria: * baseline blood pressure ≥160 mmhg * body height \< 150 cm * body weight \> 100 kg or body mass index (bmi) ≥ 40 kg/m2 * eclampsia or chronic hypertension * hemoglobin \< 7g/dl * fetal distress, or known fetal developmental anomaly
prospective study to identify patients at risk of dangerous ventricular arrhythmias

Conditions: Sudden Cardiac Death

Summary: the purpose of this study is to determine how well the device predicts susceptability to potentially lethal ventricular arrhythmias.

sudden cardiac death (scd) accounts for half of all deaths from cardiovascular causes, with an annual incidence of 1 to 2 deaths per 1000 population. in the united states this translates to between 300,000 to more than 400,000 deaths annually. results from numerous large, well designed clinical trials have demonstrated the efficacy of the implantable cardioverter-defibrillator (icd) for improving survival in patients with ischemic heart disease. however, measures used to risk stratify patients, such as left ventricular ejection fraction do not adequately identify those patients who can most benefit from icd therapy. as a result, many patients who currently receive an icd do not use the device. in addition, many more patients who could benefit from icd therapy are outside of current guidelines and do not have access to this life-saving therapy. this prospective study was intended to determine how well the harbinger wedensky modulation index (wmi) technique risk stratifies patients into two groups: those needing antiarrhythmic therapy and those who do not need antiarrhythmic therapy.

Eligibility criteria:
inclusion criteria: * post myocardial infarction patients receiving icd therapy exclusion criteria: * patients unable to give consent * pacemaker dependant patients * pregnant women

Keywords: wedensky modulation risk stratification electrophysiology noninvasive ischemic heart disease icd guidelines myocardial infarction
sensory-targeted ankle rehabilitation strategies (stars)

Conditions: Chronic Ankle Instability

Summary: the purpose of this study is to determine the effect of 3 types of sensory-targeted rehabilitation interventions on subjective and objective measures of function for those with chronic ankle instability. the investigators hypothesize that subjective and objective measures of function including self-reported disability, balance, and range of motion will improve after 2-weeks of sensory-targeted interventions.

the purpose of this study is to determine the effect of 3 types of sensory-targeted rehabilitation interventions on subjective and objective measures of function for those with chronic ankle instability. if a potential participant is deemed eligible for participation and consents to participate, he/she undergo a pretest session in which balance, gait, and range of motion will be assessed. the participant will then be randomized into one of the 4 treatment groups and undergo the first treatment which takes approximately 5 minutes. after completion of the first treatment, the participant will be immediately retested on the balance, gait, and range of motion measures. upon completion of testing on the first day, participants in the treatment groups will be asked to return for 5 more treatments over the course of 2 weeks. upon completion of the treatments, each participant will be tested on their balance, gait, and range of motion again. then, after 1 month, each participant will be contacted to do a self-reported function follow-up visit in which he/she will be asked to report how stable and functional his/her ankle has been over the past month.

Eligibility criteria:
inclusion criteria: 1. male or female 18-45 years of age 2. history of ankle sprain with at least two episodes of "giving way" within the past six months 3. score of ≥ 5 on the ankle instability instrument (aii) 4. score of ≤ 90% on the foot and ankle ability measure (faam)- activity of daily living (adl) subscale 5. score of ≤ 80% on the faam-sport subscale. exclusion criteria: 1. younger than 18 or older than 45 years 2. no history of ankle sprain or episodes of "giving way" in the past six months 3. score of ≤ 5 on the ankle instability instrument (aii) 4. score of ≥ 90% on the faam-adl 5. score of ≥ 80% on the faam-s. 6. an acute ankle sprain within the past 6 weeks. 7. previous history of lower extremity surgery with internal derangements, reconstructions, or repair 8. lower extremity injury within the past 6 months (other than ankle sprains) 9. presence of balance deficits or conditions known to affect balance as noted on the balance questionnaire including diabetes and/or vertigo.

Keywords: ankle instability sensorimotor control sensory postural control balance gait
a phase ii study of anecortave acetate for the treatment of exudative age-related macular degeneration

Conditions: AMD

Summary: the purpose of the study is to determine the concentration of anecortave acetate (15 or 30 mg versus placebo) that is safe and effective for the inhibition of the growth of blood vessels in the retina in patients with wet amd.


Eligibility criteria:
inclusion criteria: * ages 50 years and over * other protocol-defined inclusion and exclusion criteria may apply.
assessing the analgesic efficacy of naproxen sodium in postsurgical dental pain.

Conditions: Toothache

Summary: to evaluate the analgesic efficacy of a single, oral dose of a naproxen sodium extended-release tablet, compared to placebo in postsurgical dental pain.


Eligibility criteria:
inclusion criteria: * healthy, ambulatory, male and female volunteers between 16 to 45 * scheduled to undergo surgical removal of 1 - 2 impacted third molars, one of which must be at least a partial mandibular bony impaction * no use of any analgesics, nonsteroidal anti-inflammatory drugs (nsaids), aspirin, any other pain reliever (over the counter or prescription), or herbal supplements within 5 days of surgery * have moderate to severe postoperative pain on the categorical pain intensity scale (a score of at least 2 on a 4 point scale) and a score of \>/= 50 mm on the 100-mm visual analog pain severity rating scale exclusion criteria: * history of hypersensitivity to naproxen sodium, aspirin (asa), other nsaids, opioid analgesics, and similar pharmacological agents or components of the investigational products, including the placebo * evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic diseases, or malignancies * relevant concomitant disease such as asthma (exercise induced asthma is permitted), chronic sinusitis or nasal structural abnormalities causing greater than 50 percent obstruction (polyposis nasi, marked septal deviation) that can interfere with the conduct of the study * current or past history of bleeding disorder(s) * history of gastrointestinal bleeding or perforation, related to previous nsaid therapy. active, or history of recurrent peptic ulcer/hemorrhage (two or more distinct episodes of proven ulceration or bleeding)

Keywords: dental pain analgesia
recombinant human thrombopoietin (rhtpo) combining rituximab versus high-dose dexamethasone for initial treatment of primary immune thrombocytopenia (itp)

Conditions: Purpura; Idiopathic Thrombocytopenic Purpura

Summary: the project was undertaking by qilu hospital of shandong university and other 13 well-known hospitals in china. in order to report the efficacy and safety of recombinant human thrombopoietin combining with rituximab for the treatment of adults with primary immune thrombocytopenia (itp), compared to conventional high-dose dexamethasone therapy.

the investigators are undertaking a parallel group, multicentre, randomised controlled trial of 240 primary itp adult patients from 14 medical centers in china. one part of the participants are randomly selected to receive recombinant human thrombopoietin (given subcutaneously at a dose of 300units/kgfor 14 consecutive days, following with a flexible dosage depending on platelet count until the 28th day), combining with rituximab (given intravenously at a dose of 100 mg weekly for 4 weeks, i.e. day 1, 8, 15, 22; the others are selected to receive high-dose of dexamethasone treatment (given intravenously at a dose of 40 mg daily for 4 days). platelet count was evaluated before and after treatment,in order to report the conversion ratio of primary itp to chronic itp.

Eligibility criteria:
inclusion criteria: 1. meet the diagnostic criteria for immune thrombocytopenia. 2. untreated hospitalized patients, may be male or female, between the ages of 18 \~ 80 years. 3. to show a platelet count \< 30×10\^9/l, and with bleeding manifestations. 4. eastern cooperative oncology group (ecog) performance status ≤ 2. 5. willing and able to sign written informed consent exclusion criteria: 1. received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit. 2. received high-dose steroids or intravenous immunoglobulin transfusion(ivig) in the 3 weeks prior to the start of the study. 3. current hiv infection or hepatitis b virus or hepatitis c virus infections. 4. severe medical condition (lung, hepatic or renal disorder) other than itp. unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia) 5. female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period. 6. have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct coombs test. 7. patients who are deemed unsuitable for the study by the investigator.

Keywords: recombinant human thrombopoietin rhtpo rituximab dexamethasone
cilostazol after lower extremity arterial revascularization trial

Conditions: Peripheral Arterial Disease; Claudication (Finding)

Summary: twenty patients will be recruited to clear. ten will be randomized to the treatment arm (cilostazol) and tenwill be randomized to the control group. patients randomized to the treatment arm will receive cilostazol for 90 days. the primary purpose of this study is to collect quality of life data on patients undergoing peripheral revascularization in order to determine the sample size required to adequately power a trial of cilostazol versus usual care without cilostazol and its effect on quality of life.

cilostazol is the only medication approved for use in peripheral arterial disease (pad) patients to reduce claudication symptoms. contemporary data has demonstrated that cilostazol improves patency after endovascular interventions in multiple randomized trials and retrospective studies done in japan in both critical limb ischemia and claudication patients. however, cilostazol use after peripheral revascularization has been sporadic and there has been no research to estimate patient quality of life with use of cilostazol after open or endovascular lower extremity revascularization. this is a prospective investigator initiated single-center open-label, non-placebo controlled pilot study. eligible patients would be randomized to either the cilostazol treatment or the non-cilostazol treatment groups using a closed envelope randomization technique. twenty patients will be recruited and randomized; ten to the treatment group and tento the control group. the primary purpose of this pilot study is to collect quality of life data on patients undergoing peripheral revascularization in order to determine the sample size required for adequate powered trial of cilostazol versus usual care without cilostazol and its effect on quality of life.

Eligibility criteria:
inclusion criteria: * at least 35 years of age * atherosclerotic peripheral arterial disease * able to provide informed consent * lower extremity open or endovascular revascularization. exclusion criteria: * known chf (class iii/iv) * allergic reaction to phosphodiasterase inhibitors * intracranial bleeding within 3 months or active bleeding peptic ulcer disease * traumatic vascular injuries requiring revascularization * pregnant or breast feeding women or women who plan to get pregnant over the study period * planned ipsilateral major amputation within 30 days of index procedure * moderate to severe hepatic impairment.

Keywords: leg pain claudication
pediatric delirium

Conditions: Pediatric Delirium

Summary: preventing emergent delirium in pediatric ambulatory surgery through preoperative use of intra-nasal dexmedetomidine and oral midazolam.

pediatric ambulatory patients will randomly be allocated to one of two groups. group a which will receive dexmedetomidine intra-nasally at a dose of 1 mcg/kg, approximately 15-25 minutes before entering the operating room or group b which will receive midazolam orally at a dose of 0.5 mg/kg (with a maximum dose of 20 mg), approximately 10-15 minutes before entering the operating room. each subject will receive a drug acceptance scale, and parental separation anxiety scale (psas) mask acceptance scale to identify the differences in markers associated with pediatric delirium. end tidal sevoflurane value during the surgery and at the time when patient leaves the or, amount and dose of oral/rectal acetaminophen given in pacu, child's behavior for 48 hours post-operatively, and documented intake of oral analgesics will be collected to identify the reduced need for post-operative analgesia and behaviors associated with extended pediatric delirium.

Eligibility criteria:
inclusion criteria: * subjects age 3 months to 9 years * scheduled to undergo a myringotomy * american society of anesthesiologists (asa) classification of i - ii. exclusion criteria: * subjects with unrepaired cardiac defects, including cyanotic congenital heart disease. * anyone age 10 years or older. * anyone with an asa classification of iii or higher. * non-english language speaker for whom short form consent is not available.