Kornimate/medical-research-clean huggingface dataset:
an investigational immuno-therapy study of nivolumab, compared to placebo, in patients with bladder or upper urinary tract cancer, following surgery to remove the cancer

Conditions: Various Advanced Cancer

Summary: the purpose of this study is to determine the effectiveness and safety of nivolumab compared to placebo in participants who have undergone radical surgery for invasive urothelial cancer.


Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * must have had invasive urothelial cancer at high risk of recurrence originating in the bladder, ureter, or renal pelvis * must have had radical surgical resection (e.g. radical cystectomy), performed within the last 120 days * must have disease free status as determined by imaging within 4 weeks of dosing * tumor tissue must be provided for biomarker analysis * patients who have not received prior neoadjuvant cisplatin chemotherapy must be ineligible for or refuse cisplatin-based adjuvant chemotherapy exclusion criteria: * partial bladder or partial kidney removal (eg, partial cystectomy or partial nephrectomy) * secondary treatment (eg, adjuvant systemic chemotherapy for bladder cancer) following surgical removal of bladder cancer * subjects with active, known or suspected autoimmune disease * prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured * condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 day of study drug administration * positive test for hepatitis b virus surface antigen (hbv s ag) or hepatitis c virus ribonucleic acid (hcv antibody) indicating acute or chronic infection
effect of higher volume and lower dose on analgesic quality during labor analgesia with dural puncture epidural

Conditions: Analgesia

Summary: it is aimed in this study to compare the effect of using local anaesthetics in a higher volume and lower dose on the total anesthetic consumption and quality of labor analgesia with dural puncture epidural technique.

this study will be conducted as a prospective randomized, controlled, double-blind trial following the approval of the ethical committee at atatürk university medical faculty hospital and after obtaining written consent from the participating patients. the study will include pregnant women aged 20 to 45 with american society of anesthesiologists (asa) ii classification, full-term, nulliparous and singleton pregnancies. using a randomisation procedure, the participants will be allocated into two equal groups: group i and group ii.

Eligibility criteria:
inclusion criteria: 1. healthy nulliparous women 2. american society of anaesthesiology score of ii 3. during active labor 4. at weeks 37-42. 5. singlet vertex presentation 6. cervical dilation \<5 cm at the request of labor analgesia 7. vas score \>40 exclusion criteria: 1. age \ 45, 2. morbid obesity 3. presence of pregnancy-related comorbidities (e.g: gestational diebetes, gestational hypertension and preeclampsia) 4. history of drug abuse 5. contrindication for neuraxial blocks 6. conditions that increase the risk of need for cesarean section (e.g. placenta previa, uterus abnormalities or surgeries) 7. diagnosed fetal abnormalities 8. cases where dura gets punctured unintendedly with the epiduralneedle 9. cases where flow of cerebrospinal fluid (csf) is not observed after dural puncture 10. cases where a cesarean section is performed at any stage of labor 11. cases where labor is completed in 1 hour from the start of analgesia procedure.
capnography in infants ventilated with high frequency ventilation

Conditions: Infants in NICU Ventilated With HFV

Summary: the investigators hypothesize that detco2 measured by the microstream® technique via a double-lumen ett in infants ventilated with hfv would be feasible and adequately represent the arterial co2 (paco2).

all infants with double lumen ett on hfv are eligible.

Eligibility criteria:
inclusion criteria: * all intubated infants with double lumen ett ventilated with hfv exclusion criteria: * infants ventilated with single lumen ett

Keywords: hvf premature infants etco2
sarcopenic obesity in the elderly

Conditions: Sarcopenic Obesity; Diabetes

Summary: ageing is associated with progressive and generalized loss of muscle mass and muscle function, also known as sarcopenia. increasingly, obesity has become a compounding factor in ageing-related sarcopenia. the coexistence of obesity and sarcopenia is termed sarcopenic obesity (so). older adults with so are at higher risks of developing diabetes, hypertension, stroke, cardiovascular diseases, and cognitive dysfunction than those older adults who suffer from sarcopenia alone or obesity alone. however, there is insufficient information with regard to the interplay between obesity and sarcopenia. the primary objective of this study is to investigate the impact of so on insulin resistance in people aged 65-85. our hypothesis is that so positively influences insulin resistance in the elderly. we propose to investigate sarcopenia and obesity as risk factors for insulin resistance in the geriatric (65-85 years old) population.


Eligibility criteria:
inclusion criteria: this study will include both male and females aged 65-85 years. exclusion criteria: 1. lack capacity to consent for the study, or have moderate or severe cognitive impairment; 2. have difficulty ambulating as evidenced by any one of the following: 1. difficulty climbing 10 steps without resting; 2. restricted to a wheelchair 3. have difficulty performing basic activities of daily living; 4. have had treatment for cancer in the prior 3 years; 5. have history of cachexia; 6. have a history of heart failure; 7. have a permanent pacemaker in situ (due to magnetic resonance scanning); 8. have an implanted cardioverter-defibrillator (icd) in situ; 9. have had myocardial infarction within the last 6 months; 10. have any of the following chronic health conditions: peripheral arterial disease prostate cancer, rheumatoid arthritis, autoimmune myositis, chronic obstructive pulmonary disease, and asthma; 11. are receiving therapy with corticosteroids or immunosuppressants. 12. are taking direct insulin sensitizers (ppar-gamma agonists, or thiazolidinediones).
laparoscopic cholecystectomy:

Conditions: Cholecystitis

Summary: various modifications have been tried in laparoscopic cholecystectomy since its introduction. one, two and three port lc have been performed on limited scale. we aim to compare three port lc with four port lc in patients with cholelithiasis. the main objective of this study is to evaluate the outcome of 3 ports lc for treatment of cholelithiasis by comparing the result with 4 ports lc with respect to safety and efficacy.

various modifications have been tried in laparoscopic cholecystectomy since its introduction. one, two and three port lc have been performed on limited scale. we aim was to compare three port lc with four port lc in patients with cholelithiasis. the main objective of this study was to evaluate the outcome of 3 ports lc for treatment of cholelithiasis by comparing the result with 4 to study the efficacy and feasibility of 3 port and 4 port lap cholecystetctomy. 1. to compare the intraoperative and post-operative complications of 3 port and 4 port lap cholecystectomy 1. operative time, 2. days of hospital stay. 3. complication 4. post-operative pain ports lc with respect to safety and efficacy.

Eligibility criteria:
inclusion criteria: 1. age of patient between 25 and 65 years 2. diagnosis of chronic cholecystitis, symptomatic cholelithiasis exclusion criteria: 1. choledocholithiasis 2. severe acute calculus pancreatitis 3. severe co-morbid conditions (uncontrolled diabetes, hypertension, severe direct hyper bilirubinemia) 4 . previous operation or adhesion
low-dose nifedipine-valsartan combination compared to up-titrated valsartan monotherapy in essential hypertension

Conditions: Hypertension

Summary: this will be a multi-center, prospective, randomized, open-label, parallel design, two arm comparator trial. in the proposed study, the investigators will compare low-dose combination therapy of nifedipine gits/oros plus valsartan with up-titrated monotherapy of valsartan with respect to their blood pressure-decreasing effects in patients with essential hypertension.the study consists of a screening visit, followed by randomization and administration of either nifedipine gits/oros 30 mg in combination with valsartan 80 mg or valsartan 160 mg for 12 weeks of treatment.the primary efficacy parameters will be mean sbp and dbp on office bp monitoring at 12 weeks of treatment compared to baseline.


Eligibility criteria:
inclusion criteria: * men and women aged 18 - 75 years * essential hypertension not well controlled by current low dose (80 mg) valsartan monotherapy for at least 4 weeks. patients on prior treatment with monotherapy diuretic, ace-i or beta blocker or an arb other than valsartan and switched to the current low dose valsartan 80 mg monotherapy for at least 4 weeks are also eligible, provided the hypertension is still not well controlled. * office systolic blood pressure (sitting) \>140 mmhg (sitting for \>/= 5 min., no cigarettes and/or coffee/tea for \>/=30 min. before bp measurement). * bmi \<33 kg/m2 exclusion criteria: * participation in any clinical investigational drug study within the previous 12 weeks * concomitant treatments with: 1. any anti-hypertensive treatment other than valsartan 80 mg 2. cytochrome p450-3a4 inhibitors or inducers 3. potassium-sparing diuretics * severe hypertension (dbp \>/= 110 mm hg and/or sbp \>/= 180 mm hg) and/or evidence of secondary forms of hypertension * any of the following cardiovascular diseases: * history of cardiovascular shock * myocardial infarction or unstable angina within the previous 6 months * severe cardiac valve disease * past or present severe rhythm or conduction disorder. * cerebrovascular ischemic event and/or history of intracerebral hemorrhage or subarachnoid hemorrhage (sah) within the previous 12 months * type 1 or 2 diabetes mellitus * proteinuria * uncorrected hypokalemia or hyperkalemia, sodium depletion and/or hypovolemia * gastrointestinal disease resulting in the potential for malabsorption and/or severe gastro-intestinal tract narrowing; kock pouch (ileostomy after proctocolectomy) * cholestasis or biliary obstruction * liver disease or aspartate aminotransferase (ast) / alanine aminotransferase (alt) levels \>3 x upper limits of normal (uln) * renal failure, creatinine level \>2.0 mg/dl

Keywords: nifedipine gits/oros (adalat®) valsartan (diovan®) hypertension
clamshells exercise and vastrus medialis oblique strengthening exercise on patellofemoral pain syndrome

Conditions: Patellofemoral Pain Syndrome

Summary: pfps, also known as patellofemoral pain syndrome, is a prevalent musculoskeletal condition that primarily affects adolescents and young adults. when engaging in various activities, such as stair climbing, running, jumping, kneeling, or prolonged sitting, it is characterized by aching pain in the peripatellar region. any disruption of these would result in abnormal pfj overloading. normal patellar tracking on the trochlea groove relies on the coordination and balance of many structures, including soft tissues, muscles, tendons, ligaments, and the shape of articular surfaces around the knee joint. research in a variety of fields has received support the therapeutic exercise known as "clamshells" for stabilizing the pelvis by strengthening the hip abductors and external rotators.vmo strengthening exercises are also essential in keeping the patella in the trochlear groove and lowering the lateral vector force on the patellofemoral joint. this research aims to evaluate the effects of clamshells exercise and vastrus medialis oblique strengthening exercise in patients with patellofemoral pain syndrome. the study would be randomized clinical trial. total fourty two subjects will be assigned randomly by using lottery method into two groups. group a will be given clamshell exercise with baseline treatment while group b will receive targeted vastrus medialis oblique strengthening exercise with baseline treatment. after confirmation of diagnosis with physical examination as well as zohlar's test /20 cm step down test are recommended. numeric pain rating scale (nprs) and lower extremity functional scale (lefs) would be used as an outcome measure tools for pain and functional limitation respectively. measurements will be taken at (baseline and at the end of treatment session). the collected data will be analyzed in statistical package for the social sciences (spss) 25.0. parametric/non-parametric tests will be applied after testing normality of data.


Eligibility criteria:
inclusion criteria: * age 18 to 40years * both genders (male \& female) * unilateral or bilateral knee pain for at least 1-3 month, * pain provoked by at least 3 functional activities ( ascending/descending stairs, kneeling, jumping, running, squatting,hopping,prolonged sitting) * average nprs score above 3 out of 10 during previous week. * knee pain on stepping down from 20cm step height. exclusion criteria * previous history of patellar subluxation or dislocation * knee surgery within previous year * history of knee joint pathologies ( meniscus,ligament injuries,) * any fracture of lower extremity * massive effusion/any abnormal deformity of knee joint.
study to evaluate the efficacy and safety of oral difelikefalin as adjunct therapy to a topical corticosteroid for moderate to severe pruritus in subjects with atopic dermatitis

Conditions: Pruritus; Atopic Dermatitis

Summary: this is a two-part, multicenter, randomized, double-blind study to evaluate the efficacy and safety of oral difelikefalin as adjunct therapy to a topical corticosteroid (tcs) for moderate-to-severe pruritus in adult subjects with atopic dermatitis (ad).

part a of this study includes a 12-week double-blind treatment period and a 52-week open-label extension period. subjects will be randomized to receive oral difelikefalin 0.25 mg tablets bid plus tcs cream, difelikefalin 0.5 mg tablets bid plus tcs cream, placebo tablets bid plus tcs cream or placebo tablets bid plus vehicle cream. part b of this study includes a 12-week double-blind treatment period and 52-week open-label extension period. subjects will be randomized to receive oral difelikefalin 0.25 mg or 0.5 mg tablets bid plus tcs cream or oral placebo tablets bid plus tcs cream. part a results at week 12 will inform part b. subjects who participated in part a of the study may not participate in part b. all subjects will sign an informed consent form (icf) and undergo screening for study eligibility.

Eligibility criteria:
key inclusion criteria: to be eligible for inclusion into the study, a patient must meet the following criteria: * subject has clinically confirmed diagnosis of active ad; * subject has chronic pruritus related to ad; * subject has moderate to severe pruritus; * female subject is not pregnant or nursing during any period of the study. key exclusion criteria: a patient will be excluded from the study if any of the following criteria are met: * subject has clinically infected ad; * subject has pruritus attributed to a cause other than ad; * subject has any clinically significant medical condition or physical/laboratory/ecg/vital signs abnormality that would, in the opinion of the investigator, put the subject at undue risk or interfere with interpretation of study results.

Keywords: atopic dermatitis pruritus cr845 chronic itch difelikefalin itch itching generalized pruritus eczema
electroacupuncture as an adjunct to non-surgical periodontal therapy

Conditions: Periodontal Diseases; Periodontal Inflammation; Periodontitis; Acupuncture; Electroacupuncture; Periodontal Pocket

Summary: the aim of this randomized, single-masked, controlled clinical trial study was to determine if the administration of electro acupuncture improves the outcomes obtained in combination with non-surgical periodontal therapy. participants will get non-surgical periodontal therap with/without electro acupuncture. researchers will compare ea and control groups to see if there is any relationship between acupuncture application clinical periodontal parameters,serum and saliva cytokine levels.

periodontitis is a prevalent complex chronic inflammatory oral disease that can result in the progressive destruction of tooth supporting tissues and eventual loss of teeth. although pathogenic bacteria are the triggers and provokers of periodontal inflammation, the main determinant of the destruction is the host immunoinflammatory response. the host response is modified by many genetic and environmental factors as well as various systemic diseases. electroacupuncture (ea) has effects on both the immune system and inflammatory processes. the effect of acupuncture on the regulation of cytokine production has been mentioned in the literature. . no study has been found in the literature about the effects of ea on the host modulation in periodontitis patients. in this study, the investigators aimed to examine the effect of electroacupuncture application on the host modulation at periodontitis.

Eligibility criteria:
inclusion criteria: * absence of any systemic disease, * pregnancy or breast feeding; * not receiving anti-inflammatory drug therapy in the last 6 months, chemotherapy or radiotherapy; exclusion criteria: * having a systemic disease such as cardiovascular, diabetes, hypertension, thyroid organ pathologies, chronic kidney failure * pregnant/breastfeeding * medication for any reason * smoker/tobacco user * other periodontal disease other than periodontitis * chronic inflammatory disease (copd, asthma)

Keywords: periodontitis acupuncture electroacupuncture il-6 il-10 tnf-α cytokine non-surgical periodontal therapy
analgesia for total hip arthroplasty with peng block (athapeng)

Conditions: Total Hip Arthroplasty for Osteoarthritis

Summary: analgesia for total hip arthroplasty with peng block (athapeng)

total hip arthroplasty (tha) for osteoarthritis is a commonly performed surgery worldwide. it is associated with significant pain, with median pain scores in the first 24 hours postoperatively exceeding 3 on the standardized numeric rating scale (nrs). multimodal analgesia, including infusion of systemic analgesics and regional anesthesia through the pericapsular nerve group block (peng block), has demonstrated efficacy in literature, when compared to other commonly used techniques such as the iliofascial block or surgical infiltration. however, analgesia provided by the peng block appears to be incomplete, with a significant consumption of opioids in the postoperative period. the investigators hypothesis is that peng block does not cover every hip sensitive territory involved during the surgical procedure. the investigators conducted a single-center, observational, prospective study evaluating the antinociceptive effect of a peng block performed preoperatively, at various surgical time points (incision, dislocation, femoral osteotomy, acetabular reaming, femoral reaming, femoral stem impaction, reduction, closure) by monitoring the nociception level index (nol index) during general anesthesia. nol index values (0 to 100) between 10 and 25 reflect nociception control, nol index values exceeding 25 reflect excess of nociception, nol index \< 10 reflects a potential excess of opioids infusion. after surgery, pain scores (nrs), opioid consumption, and the presence of motor blockade within the first 48 hours postoperatively were also assessed. the aim of the study is to determine the efficacy of peng block combined to multimodal analgesia on intraoperative nociception and postoperative pain in patients undergoing total hip arthroplasty under general anaesthesia.

Eligibility criteria:
inclusion criteria: * adult patients (\> 18 years old) * undergoing primary hip arthroplasty for osteoarthritis * under general aneasthesia * with peng block exclusion criteria: * patient under 18 years old * severe cognitive impairment or patient under guardianship * pregnancy * allergy to local anaesthetics * chronic pain with daily opioid consumption * non sinusal cardiac rhythm

Keywords: peng block analgesia total hip arthroplasty nol index
am-101 in the treatment of post-acute tinnitus 2

Conditions: Tinnitus

Summary: the purpose of this research study is to test the safety and local tolerance of repeated treatment with am-101.

this open-label extension study is assessing the safety and local tolerance of repeated treatment with am-101 in subjects previously treated in the scope of the tactt3 study.

Eligibility criteria:
inclusion criteria: * completion of tactt3 study; * negative pregnancy test (woman of childbearing potential); * willing and able to attend the study visits. other protocol-defined inclusion criteria may apply. exclusion criteria: * adverse event leading to treatment discontinuation in tactt3; * meniere's disease, endolymphatic hydrops, acoustic neuroma, severe or fluctuating hearing loss, otitis media, otitis externa, abnormality of tympanic membrane; * ongoing drug-based therapy for otitis media or otitis externa; * drug-based therapy known as potentially tinnitus-inducing; * other treatment of tinnitus; * drug abuse or alcoholism; * subjects with psychiatric diseases requiring drug treatment; * use of antidepressant or anti-anxiety medication; * any clinically relevant disorder or abnormality in physical examination; * women who are breast-feeding, pregnant or who are planning to become pregnant during the study; * women of childbearing potential who are unwilling or unable to practice contraception. other protocol-defined exclusion criteria may apply.
endoscopic submucosal dissection for gastrointestinal neoplasms

Conditions: Digestive System Diseases

Summary: endoscopic submucosal dissection (esd) is a newly developed technique in the field of endoscopic treatment for gi neoplasms, because of its high rate of en bloc resection. the purpose of this study is to evaluate the efficacy and safety of esd for gi neoplasms.

endoscopic mucosal resection (emr) is widely accepted as a minimally invasive treatment for gi neoplasms.however, one disadvantage of emr is that lesions larger than 2 cm in diameter must be removed in pieces, which may result in a high recurrence rate of residual tumor tissue. in addition, in most patients, pathological assessment cannot be conducted after the procedure. esd can overcome the disadvantages of emr. however, it is difficult to perform esd for gi neoplasms because of the high rate of complications.

Eligibility criteria:
inclusion criteria: * submucosal tumor * mucosal tumor (t1) in patients unsuitable for surgery exclusion criteria: * endoscopic ultrasound (eus) or ct signs of metastasis * insufficient access to tumor

Keywords: endoscopic submucosal dissection gastrointestinal neoplasm