Kornimate/medical-research-clean huggingface dataset:
lornoxicam versus etodolac after third molar surgery

Conditions: Pain, Acute; Edema; Trismus

Summary: our study aimed to compare the effect of lornoxicam and etodolac on postoperative pain, edema and trismus following lower third molar extraction

20 patients included in study (4 male, 16 female). lornoxicam and etodolac was given following lower third molar extraction. pain was evaluated 2., 6., 12., 24., and 48. hours using vas. edema was evaluated by measuring tragus-labial commissure, angulus- lateral canthus of eye and angulus mandible-labial commissure. trismus was evaluated measuring mouth opening by caliper. edema and trismus was evaluated by 48. and 168. hours

Eligibility criteria:
inclusion criteria: * bilateral mesioangular impacted lower third molar * asymptomatic third molar (no history of infection) * systemically healthy person * person between aged 18-30 exclusion criteria: * people who are pregnant and lactation process * people who had any systemic disease * people who are gastrointestinal problems * people who are sensitive to drugs used in study * lower third molar associated with cysts and infections
nurse-assisted intervention "ehealth@ hospital -2-home"

Conditions: Non Communicable Diseases; Heart Failure; Colon Rectal Cancer

Summary: a randomized controlled trial with non-communicable disease patients from two medical hospitals in norway will be recruited prior to hospital discharge. the intervention group will participate in a 42-day nurse-assisted ehealth intervention "ehealth@ hospital-2-home". the intervention includes monitoring the patient's vital signs, self-reports of symptoms, health and well-being, communication between the patients and a nurse navigator in the hospital, and access to information about illness and health resources.

heart failure (hf) and colon-rectal cancer (crc) are two non-communicable diseases (ncds) prone to a high rate of hospital admissions and re-admissions, and complex health care needs. for many patients with hf and crc, self-management following hospitalization can be a challenge, and they may leave the hospital unprepared for self-managing their disease at home. the randomized controlled trial with ncd patients from two medical hospitals in norway. patients will be recruited before hospital discharge. the intervention group will participate in a 42-day nurse-assisted intervention ""ehealth@ hospital-2-home"". the intervention includes monitoring of patients' vital signs, self-reports of symptoms, health and well-being, communication between the patients and a nurse navigator in the hospital, and access to information about illness and health resources. the control group will receive care as usual. data collection will take place before the intervention (baseline), at the end of the intervention (post-1), and 6 months after baseline (post-2). data will be according to intention to treat principles. qualitative data will be analyzed using thematic analysis.

Eligibility criteria:
inclusion criteria: * all participants: symptomatic hf or surgically treated for either colon or rectal cancer (colon-rectal cancer duke's class 1-3, curative), able to speak and write norwegian exclusion criteria: * heart failure population: patient is on a waiting list for a heart transplant, requires a left assist ventricular device (lvad), and has a life expectancy \<6 months * colon-rectal cancer population: metastatic cancer, surgical complication score \> 3, and acute medical crisis.
a comparison between two strategies for postpartum anemia diagnosis and follow up after vaginal deliveries

Conditions: Postpartum Anemia

Summary: anemia diagnosis by hemoglobin level monitoring in women after vaginal delivery by symptoms versus screening of women at increased risk for post-partum anemia.

anemia is common following delivery. it is associated with some serious complications including increased risk for syncope and in severe cases even cardiogenic shock. yet, anemia-associated symptoms might manifest relatively late after the patient have lost a fair amount of blood, which was not diagnosed early enough. to date, there are not acceptable guidelines for monitoring hemoglobin levels after delivery. theoretically, there are 2 approaches for hemoglobin monitoring - one by taking hemoglobin levels in order to diagnose anemia in patients reporting anemia-associated symptoms. the other approach is by screening of women at increased risk for post-partum anemia. in the present study we aimed to compare those 2 approaches.

Eligibility criteria:
inclusion criteria: * pregnant women after vaginal delivery exclusion criteria: * pregnant women with known sensitivity to the product iron sucrose * pregnant women after cesarean section
safety and tolerability of asa404 administered in combination with docetaxel in japanese patients with solid tumors

Conditions: Advanced or Recurrent Solid Tumors

Summary: this study will assess the tolerability of combination therapy with asa404 and docetaxel in japanese patients with advanced or recurrent solid tumors.


Eligibility criteria:
inclusion criteria: 1. patients with confirmed solid tumors whose disease has progressed or recurred after treatment at lease one therapy, except docetaxel 2. who performance status of 0-1 exclusion criteria: 1. patients having symptomatic cns tumor/metastasis and requiring treatment 2. patients who have received prior therapy with asa404 or other vascular disrupting agents 3. patients with systolic bp \> 160mmhg and/or diastolic bp \> 90mmhg 4. patients with fluid retention 5. patients with any one of cardiotoxicities 6. concomitant use of drugs with a risk of prolonging the qt interval 7. known allergy or hypersensitivity to taxane or polysorbate 80 other protocol-defined inclusion/exclusion criteria may apply

Keywords: asa404, vadimezan, docetaxel
new truncal nerve blocks for thoracoscopic surgery and open heart surgery.

Conditions: Postoperative Pain

Summary: this study is divided to two sub-studies. first sub-study evaluates if serratus anterior plane block (sapb) reduces opioid consumption after thoracoscopic surgery. secondly continuous sapb is compared to continuous intercostal blockade. second sub-study evaluates if subpectoral interfascial plane block (sip) reduces opioid consumption after medial sternotomy.

serratus anterior plane block (sapb) - sub-study in this sub-study 120 patients will be randomly assigned to one of four groups: sapb group a 30ml of ropivacaine 7,5mg/ml is injected above m. serratus anterior after thoracoscopic lung surgery. injection is done under ultrasound guidance. sapb group b 30ml of sodiumchloride 0.9 is injected above m. serratus anterior after thoracoscopic lung surgery. injection is done under ultrasound guidance. sapb group c 30ml of ropivacaine 7,5mg/m is injected above m. serratus anterior after thoracoscopic lung surgery. also a multi-holed catheter is left in place. through catheter 20ml ropivacaine 2mg/ml is injected every 12 hours after surgery. sapb group d a multi-holed catheter is placed in single intercostal space under thoracoscopic visualization. 20ml of ropivacaine 7,5mg/ml is injected after application of the catheter, also a continuous infusion of ropivacaine 2mg/ml is started. rate of the infusion is determined by patients weight. subpectoral interfascial plane block (sip) - sub-study in this sub-study 80 patients will be randomly assigned to one of two groups: sip group a 20ml of ropivacaine 7,5mg/ml is injected under both pectoralis major muscles before medial sternotomy. injection is done under ultrasound guidance. sip group b 20ml of sodiumchloride 0.9 is injected under both pectoralis major muscles before medial sternotomy. injection is done under ultrasound guidance. every patients postoperative pain is treated with intravenous oxycodone pca-pump. the investigators will evaluate post operative pain based on the numeric rating scale, 24 hours oxycodone consumption. the investigators will also evaluate post operative chronic pain using three questionnaires: eq5d, stait-trait and pain detect. in sapb sub-study the questionnaires are done three weeks and 6 months post. operatively. in sip sub-study the questionnaires are done 6 months and 12 months post.operatively.

Eligibility criteria:
inclusion criteria: * elective thoracoscopic lung surgery or elective open heart valve surgery exclusion criteria: * dm1 with complications, lack of co-operation, refusal, chronic pain, chronic intake of opioids or use of snri or tricyclic antidepressants.

Keywords: cardiac surgery thoracic surgery nerve block
influence of different airflow resistances on drug effect of 50μg salmeterol and 6 μg formoterol

Conditions: Asthma

Summary: effect of inhaled drugs administered as dry powder is not only dependent on drug efficacy but also on technical properties of the inhalers. different inhalers have different internal resistances and therefore it is expected that patients with limited airflow may have different exposure rates of drugs delivered from different devices


Eligibility criteria:
inclusion criteria: * asthma reversibility \>15% and 200 ml in total fev1 \<85% of normal exclusion criteria: * smoking history \>20 pack years treatment with ics \>500μg fluticasone or aquivalent in the last 4 weeks asthma exacerbation in the last 4 weeks

Keywords: asthma salmeterol formoterol airway resistance
study of hot flashes and night sweats in postmenopausal women receiving combination raloxifene and oral estrogen

Conditions: Vasomotor Symptoms; Endometrial Safety

Summary: this pilot study was designed to explore the effects of combined treatment with raloxifene hcl 60 mg and oral 17 beta-estradiol 1mg/day on the number of vasomotor episodes (hot flashes plus night sweats) in postmenopausal women discontinuing continuous combined hormone replacement therapy (cchrt) compared to women treated with raloxifene hcl 60 mg alone.


Eligibility criteria:
inclusion criteria: * post menopausal women, 50-70 years of age * had taken cchrt for at least 6 months prior to study entry * no unexplained vaginal bleeding in the 3 months prior to study entry * understand and sign an informed consent document exclusion criteria: * prior hysterectomy * endometrial thickness (excluding endometrial fluid) greater than 8 mm or endometrial fluid greater than or equal to 4 mm at study entry * abnormal pap smear at study screening or within the preceding 3 years * abnormal transvaginal ultrasound result at study screening * past or current history of malignant neoplasms
healthy nordic foods to prevent cardiometabolic risk in obese subjects

Conditions: Obesity; Cardiovascular Risk Factor; Diet Modification

Summary: this project will examine whether long-term consumption of healthy nordic foods can maintain a healthy weight also after weight loss, and decrease abdominal fat accumulation and cardiometabolic risk. the study will be performed with the aim to achieve a substantial body weight loss in the first phase by prescribing a standardized low caloric dietary formula. the follow-up phase will be a body weight-maintenance period and the subjects will be randomised to a healthy nordic diet group and a control diet group. during the study body weight will be monitored and other measurements will include insulin sensitivity, blood lipids and inflammation markers.


Eligibility criteria:
inclusion criteria: * age 25-67 years, bmi 30-40 kg/m2, waist circumference men \>102cm and women \> 88cm or sagittal abdominal diameter men \>22cm and women \>20cm, stable body weight exclusion criteria: * glucose \>7.0 mmol/l, b-hb1ac \>48 mmol/l, triglycerides \>4 mmol/l, total cholesterol \>8 mmol/l, bloodpressure \>160/100 mmhg, chronic disease, gastro-intestinal disease, hyper-/hypothyroidism, alcohol abuse, cancer, gastric bypass operation, gluten allergy, lactose intolerance, pregnancy
enterogermina® (bacillus clausii) in the management of diarrhea in children

Conditions: Gastroenteritis

Summary: primary: * to demonstrate the efficacy of enterogermina® in reducing the duration of acute diarrhea in children secondary: * to evaluate the safety of enterogermina® in acute diarrhea in indian children


Eligibility criteria:
inclusion criteria: * non hospitalised infants and children attending clinic/outpatients with acute diarrhea (\>3 liquid or watery stools occurring in a 24-hour period) of less than 48 hours duration exclusion criteria: * history of presence of blood, pus, or mucus in stools * severe dehydration (world health organization criteria) * severely malnourished patients * treatment with antibiotics, probiotics, or prebiotics within a period of 2 weeks before enrolment * history of conditions known to producing immunodeficiency (acquired immune deficiency syndrome, other congenital immunodeficiency syndrome, drug therapy with steroids, anticancer drugs etc) * known hypersensitivity to bacillus clausii or other probiotics. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
study of s-1 plus lv for advanced gastric cancer

Conditions: Gastric Cancer

Summary: the purpose of this study is to evaluate the effectiveness and safety of s-1 plus leucovorin (1 week on and 1 week off) as first-line treatment for patients with metastatic and recurrent gastric cancer.

patients enrolled in this study were orally treated with s-1 in doses of 40 mg (body surface area (bsa)\<1.25 m2), 50 mg (1.25≤bsa\<1.50 m2) and 60 mg (bsa≥1.50 m2) b.i.d. on days 1-7 in combination with lv given simultaneously at a ﬁxed dose of 25 mg b.i.d. on days 1-7, followed by a 7 day rest. treatment courses were repeated every 2 weeks. treatment was continued until progressive disease (pd), unacceptable toxicity or patient refusal.

Eligibility criteria:
inclusion criteria: * histologically conﬁrmed metastatic or recurrent gastric cancer * with at least one measurable lesion by recist criteria * an age of ≥ 18 * adequate oral intake * no previous radiotherapy, immunotherapy, biotherapy, hormonotherapy and chemotherapy within 5 years (adjuvant chemotherapy without s-1 was allowed if ﬁnished 6 months before enrollment) * an eastern cooperative oncology group (ecog) performance status of 0 or 1 * adequate bone marrow function, hepatic function and renal functions exclusion criteria: * a history of hypersensitivity to s-1 or lv, usage of drugs interacting with s-1 * serious concomitant conditions (severe heart disease, pulmonary ﬁbrosis, intestinal obstruction, enteroplegia, renal failure, liver failure, pre-existing sensory neuropathy ≥ grade 2, uncontrolled infections, psychogenic disorders, human immunodeﬁciency virus infection, severe diarrhea, nausea, or vomiting, severe ascites or pleural effusion, etc.) * extensive bone metastasis, brain metastasis or meningeal metastasis * another synchronous cancer * surgery within 3 weeks before enrollment * participating in other clinical studies * women who were or to be pregnant, nursing infants, and men who were to conceive children

Keywords: advance gastric cancer, s-1 plus leucovorin, orr, os, ttp, ttf, adverse events, pharmacokinetics
dendritic cell vaccination in patients with advanced melanoma

Conditions: Melanoma

Summary: the purpose of this study is to investigate a method of using dendritic cells (a kind of white blood cell) as a vaccine to stimulate your own immune system to react to your melanoma cells.

this is a single arm open label trial that will assess the safety and tolerability of mature dendritic cell (mdc3/8) vaccine (primer and booster) in subjects with stage iii and stage iv melanoma, followed by treatment with pembrolizumab (anti-pd-1 therapy). eligible patients that provide written informed consent will undergo apheresis to collect blood mononuclear cells for vaccine production approximately 1 week prior to vaccine infusion. each study subject will receive cyclophosphamide 300mg/m\^2 intravenously or by mouth 3 to 4 days prior to the vaccine dose, to deplete regulatory t cells. for each vaccine dose, all subjects will receive autologous dendritic cells pulsed with melanoma tumor-specific peptides. on day 1, the subject will receive the primer vaccine dose; this will be followed by two booster vaccine doses at 6 weeks apart. peripheral blood will be taken weekly to monitor the immune response to each peptide by tetramer assay. re-staging will occur after the 3rd vaccine dose, along with tumor biopsy and second apheresis. anti pd-1 therapy (standard of care) will commence 7-8 weeks after the subject's last dendritic cell vaccine.

Eligibility criteria:
inclusion criteria: * histologically confirmed stage iii and stage iv m1a/m1b/m1c melanoma. measurable disease is not required for enrollment eligibility and patients with completely resected disease are permitted. * male or female patients age greater than or equal to 18 years * ecog (eastern cooperative oncology group) performance status 0-2 * required initial laboratory values (performed within 14 days prior to eligibility confirmation by physician-investigator): * wbc (white blood cells) \>3,000/mm3 * hg (hemoglobin) greater than or equal to 9.0 gm/dl * platelets \>75,000/mm3 * serum bilirubin \< 2.0 mg/dl * serum creatinine \< 2.0 mg/dl * subjects of reproductive potential must agree to use a medically accepted birth control method during the trial and for at least two months following the trial. * provide written informed consent. exclusion criteria: * prior treatment with more than one line of cytotoxic chemotherapy; prior treatment with one line of cytotoxic chemotherapy is permitted. prior treatment with targeted therapy (such as ipilimumab, anti-pd1, or braf + mek inhibitor combination) is permitted. * active untreated cns (central nervous system) metastasis * active infection * prior malignancy (except non-melanoma skin cancer) within 3 years * pregnant or nursing (lactating) women * concurrent treatment with high-dose systemic corticosteroids; local (inhaled or topical) steroids are permitted * known allergy to eggs * prior history of uveitis or autoimmune inflammatory eye disease * known positivity for hepatitis b antibody, hepatitis c antibody, or hiv antibody
combined chelation treatment with deferiprone and deferoxamine in thalassemia major

Conditions: Beta-Thalassemia

Summary: thalassemia major is a genetic disorder affecting hemoglobin synthesis, rendering individuals dependent upon lifelong blood transfusions. consequently, iron overload occurs and patients have shortened life expectancy with the most common cause of death being heart failure. this trial tests whether the combination of traditional therapy (deferoxamine) with a newer drug (deferiprone) will prove more effective in removing cardiac iron than deferoxamine alone.

thalassemia major (tm) is a hereditary anemia resulting from a single gene defect that results in abnormal red cell production. the survival of affected individuals is dependent upon lifelong blood transfusions. unfortunately, this causes total body iron overload, and 50% of the patients in the uk are dead by the age of 35. approximately 70% of these deaths result from heart failure which results as a consequence of cardiac iron toxicity. a cardiovascular magnetic resonance (cmr) technique (which exploits the fact that t2\* signal decay relates to tissue iron) developed at the royal brompton hospital provides a non-invasive and reproducible assessment of cardiac iron. cmr therefore provides a very useful method to assess response to new treatments in this condition. using cardiac t2\* as a primary endpoint, we will investigate whether the oral chelator, deferiprone in combination with traditional treatment (deferoxamine), is superior in removing cardiac iron as compared to deferoxamine alone. this trial will provide the first randomized controlled, double-blinded, evidence for the efficacy of combination treatment in tm.

Eligibility criteria:
inclusion criteria: * beta thalassemia major * maintaining pre-transfusion hemoglobin of 9 g/dl * myocardial t2\* between 8 and 20 ms * ability to give informed consent * male or female * age \>18 years * any ejection fraction * confirmation of effective contraception throughout the trial (both men and women) exclusion criteria: * implant incompatible with mr (magnetic resonance), such as pacemaker, claustrophobia, or other condition making cmr impossible or inadvisable * neutropenia within 12 months (anc \<1.5 x10\^9/l), unless normal at screening * thrombocytopenia within 12 months (\<50 x10\^9/l), unless normal at screening * liver enzymes \> 3 times upper limit of normal * patients who have previously received deferiprone for a total of more than 6 months over the last 5 years. * patients with a previous reaction to deferiprone

Keywords: randomized controlled trial deferiprone deferoxamine iron chelation beta thalassemia major
latino study - a study of pegasys (peginterferon alfa-2a (40kd)) and copegus (ribavirin) in treatment-naive patients with chronic hepatitis c-genotype 1.

Conditions: Hepatitis C, Chronic

Summary: this single arm study will evaluate the efficacy and safety of pegasys (180 micrograms sc weekly) plus ribavirin (1000-1200mg po daily) in treatment-naive latino patients versus non-latino caucasian patients with chronic hepatitis c- genotype 1. the anticipated time on study treatment is 3-12 months and the target sample size is 500+ patients.


Eligibility criteria:
inclusion criteria: * adult patients 18-65 years of age * chronic hepatitis c , genotype 1 * serologic evidence of chc infection by an antibody test * chronic liver disease, consistent with chc infection on a liver biopsy obtained within the past 18 months * compensated liver disease * use of 2 forms of contraception during the study in both men and women exclusion criteria: * previous interferon or ribavirin therapy * systemic antiviral therapy less than 24 weeks before first dose of study drug or expected need for this treatment any time during the study * medical condition associated with chronic liver disease (eg, hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposure) * decompensated liver disease * women who are pregnant or breastfeeding
feasibility and safety of acupuncture for systemic lupus

Conditions: Systemic Lupus Erythematosus

Summary: the aim of this pilot study was to evaluate whether acupuncture is safe and acceptable to people with systemic lupus erythematosus (sle). twenty-four sle patients were assigned randomly to receive either 10 sessions of acupuncture, 10 sessions of a minimal-needling control intervention, or their usual medical care alone. it was hypothesized that acupuncture would be safe for people with sle, and that participants would be able to complete their assigned treatment within 5 to 6 weeks.


Eligibility criteria:
inclusion criteria: * diagnosed with sle, 18 years old or older, pain duration at least 3 times per week for at least 3 months, medications and doses stable for the past month, able to speak, read, and understand english, and provide informed consent. exclusion criteria: * known pregnancy, active uncontrolled organ involvement, steroid dose greater than 10 mg per day, platelets \< 100,000, previous course of acupuncture treatment.