Kornimate/medical-research-clean huggingface dataset:
a study of gemcitabine and cyberknife radiation therapy for pancreatic cancer

Conditions: Pancreatic Cancer

Summary: people with pancreatic cancer that cannot be cured by surgery are being asked to participate in this study. the purpose of this study is to test the ability of the radiation oncologists to administer cyberknife therapy along with gemcitabine chemotherapy for patients with pancreatic cancer. radiation and gemcitabine are both effective at killing cancer cells but they generally cannot be given at the same time. cyberknife therapy is highly focused radiation that is being used extensively at georgetown university and around the united states to treat a number of cancers. it is believed that because cyberknife is so highly focused it can be given safely with regular doses of chemotherapy to attack cancer cells in two ways at the same time. this research is being done because it is not known if using cyberknife with chemotherapy will be a safe way to treat pancreatic cancer.

this is a single arm, open-label pilot study of cyberknife plus gemcitabine in 10 patients with locally advanced pancreatic cancer who have not received prior local or systemic therapy for their pancreatic cancer.

Eligibility criteria:
inclusion criteria: * histologically proven unresectable, non-metastatic pancreatic adenocarcinoma with measurable or evaluable disease and without involvement of the duodenum * performance status 0-2 * no prior anticancer therapy for pancreatic adenocarcinoma * no prior anticancer therapy of any kind within the last 5 years * adequate hepatic, bone marrow, and renal function * life expectance of \> 12 weeks * women of childbearing potential must have a negative serum pregnancy test exclusion criteria: * duodenal involvement of pancreatic cancer * metastatic cancer * active severe infection, or known chronic infection with hiv, hepatitis b virus, or hepatitis c virus * cardiovascular disease including unstable angina, therapy for life-threatening ventricular arrhythmia, myocardial infarction, stroke, or congestive heart failure within the last 6 months * life-threatening visceral disease or other severe concurrent disease * pregnant or breastfeeding * anticipated patient survival under 3 months * another active malignancy within the past 5 years except for cervical cancer in situ, in situ carcinoma of the bladder or non-melanoma carcinoma of the skin.

Keywords: pancreas newly diagnosed cyberknife gemcitabine
impact on the intestinal microbiota of treatment with ceftriaxone in women's acute community pyelonephritis

Conditions: Pyelonephritis Acute

Summary: acute pyelonephritis (apn) corresponds to infections of the renal parenchyma. the annual incidence of these infections is estimated at 4-6 million cases in france, with 60 to 90% of patients managed in general city medicine. the ceftriaxone, parenteral third-generation cephalosporin (c3g), occupies an important place in the antibiotic treatment of these infections: this is the recommended probabilistic treatment, and in some situations the treatment can be continued in its entirety via a ceftriaxone monotherapy. the aim of the last antibiotic plan is to avoid the use of antibiotic therapies with a high selection capacity (cephalosporins, penicillins, fluoroquinolones, etc.) and thus reduce the incidence and prolongation over time of the digestive carriage of multi-resistant bacteria . to date, there have been few studies evaluating the impact of ceftriaxone on the emergence of multi-resistant bacteria on an individual scale, with rather heterogeneous results (13-86% c3g resistance). thus, before considering randomized studies comparing the ecological impact of different molecules or therapeutic regimens in the treatment of anp, it is necessary to have a precise and rigorous evaluation of the ecological impact of the molecule reference in this indication. the investigators propose a study to evaluate the impact on the digestive flora at 1 month of a ceftriaxone antibiotic therapy (7 days) in the management of acute pyelonephritis in women.


Eligibility criteria:
inclusion criteria: * female * over 18 years old * admitted to the emergency department with a diagnosis of pna (simple or at risk of complications, without signs of seriousness) exclusion criteria: * hypersensitivity to ceftriaxone, to another cephalosporin or to any of the excipients * a history of severe hypersensitivity (eg anaphylactic reaction) to another class of antibacterial agent in the beta-lactam family (penicillins, monobatams and carbapenems) * severe pyelonephritis, including obstructive apn * pyelonephritis in patients with a urinary catheter * antibiotic treatment in the previous 6 months * chronic dialysis patient * patient with hepatic impairment * pregnancy or breast-feeding in progress
correlates and consequences of increased immune activation in injection drug users

Conditions: Intravenous Drug Usage

Summary: the goal of this study is to learn how injection drug use may affect the immune system.

the goal of this study is to learn how injection drug use may affect the immune system. one way to measure this is by looking at the blood and the gut, or gastrointestinal tract at the same time. it is thought that activating the immune system by injection drug use may increase destruction of immune cells in the gut. to test this theory, the investigators are enrolling hiv-negative injection drug users, hiv-negative people who do not use drugs and hiv-negative former injection drug users.

Eligibility criteria:
inclusion criteria: * ability to give informed consent * between the ages of 18 and 55 * absence of medical conditions that would preclude flexible sigmoidoscopy * absence of active opportunistic infection requiring active therapy including antibiotics or anti-neoplastics (note this does not include prophylactic antibiotic therapy) exclusion criteria: * history of bleeding disorder * platelet count below 70,000 * inr\>1.5 or ptt\>2x control * active use of anticoagulants or aspirin therapy that cannot be interrupted * comorbid diagnosis of inflammatory bowel disease * pregnancy, incarceration, mentally disabled individuals * hiv-1 infection * currently on hepatitis c treatment
pd-l1 inhibitor rechallenge after pd-1 immunotherapy for patients with solid tumor beyond lung cancer

Conditions: Efficacy; Safety

Summary: anti-pd-l1 immune checkpoint inhibitor, is approved for the treatment of patients with unresectable, stage iii nsclc whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy, or as first-line treatment of patients with es-sclc in combination with etoposide and either carboplatin or cisplatin in china. the clinical data regarding the pd-l1 inhibitor in other solid tumors are limited.investigators would observe and analyze the effectiveness and safety of pd-l1 inhibitor for patients with advanced - solid tumors beyond lung cancer after muti-line therapy to explore the synergistic effect of pd-l1 inhibitor rechallenge after pd-1immunotherapy.


Eligibility criteria:
inclusion criteria: * signed informed consent form * ability to comply with protocol * aged ≥ 18 years * histologically documented advanced solid tumor beyond lung cancer * disease progression during or following at least one line treatment containing pd-1 immunotherapy. * measurable disease, as defined by recist v1.1 * ecog performance status of 0 or 1 * life expectancy ≥ 12 weeks * adequate hematologic and end organ function, defined by the following laboratory results obtained within 14 days prior to the first study treatment: anc ≥ 1.5 × 109/l (without granulocyte colony-stimulating factor support within 2 weeks of laboratory test used to determine eligibility) wbc counts \> 2.5 × 109/l and \< 15 × 109/l lymphocyte count ≥ 0.5 × 109/l serum albumin ≥ 2.5 g/dl platelet count ≥ 100 × 109/l (without transfusion within 2 weeks of laboratory test used to determine eligibility) hemoglobin ≥ 9.0 g/dl patients may be transfused or receive erythropoietic treatment to meet this criterion. liver function tests meeting one of the following criteria: ast or alt ≤ 2.5 × upper limit of normal (uln), with alkaline phosphatase ≤ 2.5 × uln or ast and alt ≤ 1.5 × uln in conjunction with alkaline phosphatase \> 2.5 × uln serum bilirubin ≤ 1.5 × uln patients with known gilbert's disease who have serum bilirubin level ≤ 3 × uln may be enrolled. inr and aptt ≤ 1.5 × uln this applies only to patients who are not receiving therapeutic anticoagulation; patients receiving therapeutic anticoagulation should be on a stable dose for at least 1 week prior to randomization. creatinine clearance ≥ 30 ml/min cockcroft-gault, chronic kidney disease epidemiology collaboration, or modification of diet in renal disease formulas may be used for creatinine clearance calculation. note that 24-hour urine collection is not required but is allowed. exclusion criteria: * active or untreated cns metastases as determined by computed tomography (ct) or magnetic resonance imaging (mri) evaluation during screening and prior radiographic assessments * leptomeningeal disease * uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures * uncontrolled hypertension * autoimmune disease * had undergone a serious anaphylactic reaction in previous immunotherapy
medication reconciliation in pulmonary hypertension

Conditions: Pulmonary Hypertension; Pulmonary Hypertension Chronic Thromboembolic; Pulmonary Arterial Hypertension

Summary: pulmonary hypertension (ph) is a life threatening condition. in ph, pulmonary arterial hypertension (pah) and chronic thrombo-embolic chronic pulmonary hypertension (cteph) are two rare diseases requiring specific and complex drug management. in france ,a part of these treatments ,only available in hospital pharmacies, are generally unknown from community health care professionals despite the high risk of drug-interactions and side effects. anticipating medication errors at the begging of the disease is therefore important, and could be done through medication reconciliation.

medication reconciliation (mr) will be done for patients hospitalized in the french referral center for ph for pah or cteph. detected medication errors will be tracked and fixed by the physician before the end of hospitalization. a synthesis of new/stopped and modified treatments will be given to the patient as well as his related healthcare professionals (community pharmacist and general practioner) to ensure the maintaining of the new therapeutic management and the understanding of drugs modification. to compare the potential decrease of medication errors promoted by mr, a retrospective mr will be also done for patients without mr at 1st hospitalization but at the next one (3 to 12 months after).

Eligibility criteria:
inclusion criteria: * patient affiliated or entitled to a social security scheme * at least 18 years old * patient with enlightened information of the study and not opposed with it. * for patient without mr: patient hospitalized for the first re-evaluation of pah or cteph within 12 months following the first assessment hospitalization (ie: first right heart catheterization at bicetre hospital). * for patient with mr: patient hospitalized for first assessment (first right heart catheterization at bicetre hospital) of pah or cteph exclusion criteria: * patient suffering from another form of ph * patient under guardianship or curator * inability to give information to the patient either due to language barrier or to cognitive impairment * patient hosted in institution on discharge from hospital (follow-up care and long-term rehabilitation) * patient with a life expectancy of less than 1 year * patient on transplant list * patient refusal * length of stay \< 48 hours

Keywords: pulmonary hypertension medication reconciliation medication errors pharmacist rare disease
problem behavior assessment and intervention in idea part c services

Conditions: Problem Behavior; Developmental Delay; Developmental Disability

Summary: the purpose of this study is to evaluate the effect of function-based assessment and intervention to reduce problem behavior in children with developmental disability or delay in the context of idea part c services. the investigators will conduct a single-case study to evaluate the efficacy of the intervention.


Eligibility criteria:
child inclusion criteria: * age birth to 5 years old * has a developmental disability or delay based on caregiver report and/or receiving early intervention services * has problem behavior, as reported by the caregiver and/or early intervention professional caregivers (e.g., parent, grandparent) of eligible child participants will participate with their child as the implementer of all procedures. an early intervention professional will participate with each caregiver-child dyad to coach the caregiver, in addition to the researcher.

Keywords: early childhood problem behavior home-based services idea part c services
temporomandibular joint function, oral habits and pain complaints of pregnant women

Conditions: Temporomandibular Disorders (TMD); Pregnancy

Summary: the aim of this study is to examine the temporomandibular joint functions, oral habits and pain complaints of pregnant women. .

when looking at the literature, it is seen that physiological and hormonal changes that occur in pregnant women affect the musculoskeletal system and pain threshold of women. these changes seen in pregnant women and their psychological levels throughout the process also contribute negatively to the process.due to the insufficiency of studies examining temporomandibular joint (tmj) problems and oral habits in pregnant women and the contradictory results in existing studies, it is seen that new studies are needed.

Eligibility criteria:
inclusion criteria (pregnancy women): * being between the ages of 18-45, * at least primary school graduate, * able to speak and understand turkish, * women diagnosed with pregnancy by usg, * singleton pregnancy, * agreeing to participate in the study voluntarily. exclusion criteria (pregnancy women): * those with any systemic disease concerning the musculoskeletal system, * women with any type of disability, * having communication problems, * multiple pregnancy, * refusing to participate in the study. inclusion criteria (non-pregnancy women): * being between the ages of 18-45, * at least primary school graduate, * able to speak and understand turkish, * agreeing to participate in the study voluntarily. exclusion criteria (non-pregnancy women): * those with any systemic disease concerning the musculoskeletal system, * women with any type of disability, * having communication problems, * refusing to participate in the study.

Keywords: temporomandibular disorders pregnancy oral habits pain
evaluating the safety and efficacy of duloxetine in the prevention of post endoscopic retrograde cholangiopancreatography pancreatitis

Conditions: Biliary Disease

Summary: endoscopic retrograde cholangiopancreatography (ercp (, a key tool that is used in diagnosis and treatment of pancreato-biliary diseases. post-ercp pancreatitis (pep) is the most common and serious complication that can occur following this procedure and can lead to significant morbidity and mortality. a variety of patient-related and procedure-related factors have been associated with higher rates of pep.


Eligibility criteria:
inclusion criteria: * age more than 18 years old. * gender: males and females * patients with suitable indications for ercp due to suspected pancreato-biliary disorders. * blood amylase and lipase levels before ercp are within the normal limits exclusion criteria: * uncontrolled diabetes mellitus (dm) * severe bleeding tendency * impaired renal function (serum creatinine \> 2 mg/dl), (creatinine clearance \<30 ml/min) * patients with severe heart disease. * subjects who underwent prior biliary or pancreatic sphincterotomy or dilatation or stenting of either duct. * currently pregnant or nursing * admission due to established pancreatitis before ecrp * unwillingness to undergo ercp.
a study to evaluate the safety, pharmacokinetics, and efficacy of img-007 in adults with atopic dermatitis (ad)

Conditions: Atopic Dermatitis; Moderate-to-severe Atopic Dermatitis; AD

Summary: the primary objective of this study is to evaluate the safety of img-007 in adults with moderate-to-severe ad. the secondary objectives are to evaluate the pharmacokinetics and efficacy of img-007 in ad patients.

this is a phase 1b/2a study to assess the safety, tolerability, pk, efficacy, and pd of multiple doses of img-007 in participants with ad. the study will consist of two cohorts with three periods: a screening period of up to 5 weeks, a 12-week treatment period, and a 12-week follow-up period. cohort 1 is open-label, with approximately 15 participants to receive three iv infusions of img-007 dose 1 over 4 weeks. cohort 2 is randomized, double-blind and placebo-controlled, with approximately 40 participants to be randomized in a 3:1 ratio to receive three iv infusions of img-007 dose 2 or matching placebo over 4 weeks.

Eligibility criteria:
key inclusion criteria: * male or female aged ≥ 18 and \< 75 years. * moderate-to-severe ad. * documented history of inadequate response or lack of tolerability to a stable regimen of one or more topical treatment before the screening visit, or for whom topical treatments are otherwise inadvisable. * female participants who are not pregnant or breastfeeding and meet at least one of the following conditions: not of childbearing potential or of childbearing potential and agrees to use a highly effective method of contraception. key exclusion criteria: * known hepatitis b, hepatitis c, or human immunodeficiency virus infection. * evidence of active or latent tuberculosis (tb). * history of untreated or inadequately treated tb infection. * active infection requiring treatment with systemic antibiotics, antivirals, antifungals, antiparasitics or antiprotozoals at the screening visit. * active unstable pruritic skin conditions in addition to ad that would interfere with the assessment of ad based on the investigator's clinical judgement. * other conditions or laboratory abnormality that could increase the risk associated with study participation or could interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into the study.

Keywords: img-007 atopic dermatitis dermatitis, atopic dermatitis eczema skin diseases immune system diseases dermatologic agents
study to evaluate the safety and efficacy of oral vadadustat in pediatric participants with anemia of chronic kidney disease naive to erythropoiesis-stimulating agents

Conditions: Anemia of Chronic Kidney Disease

Summary: this study will assess the safety and efficacy of once daily dosing of vadadustat for the treatment of pediatric participants with anemia of chronic kidney disease (ckd) naive to erythropoiesis-stimulating agent (esa) treatment.


Eligibility criteria:
inclusion criteria: * diagnosis of anemia of chronic kidney disease (ckd) * diagnosis of non-dialysis-dependent (ndd) ckd with an estimated glomerular filtration rate of greater than (\>) 10 and less than (\<) 60 milliliters/minute/1.73 meters\^2 (ml/min/1.73 m\^2 ) or diagnosis of dialysis dependent (dd) ckd * mean screening hemoglobin (hb) \<10.0 grams/deciliters (g/dl) * transferrin saturation ≥ 20% exclusion criteria: * anemia due to a cause other than ckd * active bleeding or recent clinically significant blood loss * treatment with an erythropoiesis-stimulating agents (esa) within 8 weeks prior to screening * history of sickle cell disease, myelodysplastic syndromes, bone marrow fibrosis, hematologic malignancy, myeloma, hemolytic anemia, thalassemia, or pure red cell aplasia * red blood cells transfusion within 4 weeks * serum albumin level \<2.5 g/dl * uncontrolled hypertension * active malignancy or treatment for malignancy within the past 2 years prior to screening * evidence of iron overload or diagnosis of hemochromatosis * known hypersensitivity to vadadustat or any excipients in vadadustat tablet

Keywords: anemia chronic kidney disease erythropoiesis stimulating agent dialysis vadadustat pediatric population children kidney disease hypoxia-inducible factor (hif) prolyl hydroxylase inhibitor
condylar position changes and tmj functions after bsso mandibular setback, low medial cut.

Conditions: Maxillofacial Abnormalities; Mandible Prognathism; Skeletal Malocclusion

Summary: this study hypotheses that using low medial cut osteotomy bsso in mandibular setback can be an efficient and effective method to limit the bony segment interferences , decreasing muscles stripping during osteotomy ,decrease condylar torque and so securing preoperative condylar position during bsso in comparison with using high medial cut bsso.

research question: description of research question: p: population: patients with facial skeletal deformity and need for mandibular setback using bilateral sagittal split osteotomy (bssro) alone or combined with lefort osteotomy. i: intervention: patients with facial skeletal deformity and need and for mandibular setback using low medial cut osteotomy as modification of bilateral sagittal split ramus osteotomy (bssro). c: comparator: patients with facial skeletal deformity and need and for mandibular setback using traditional high medial cut osteotomy bilateral sagittal split ramus osteotomy (bssro). o: outcome: comparing the post-operative condylar positions changes and tmj functions of two osteotomies. research question: is using low medial cut osteotomy modification in bssro in mandibular setback will provide more control over proximal segment position than traditional high medial cut through: 1. limit the segments interference and so maximizes the passive bony contact across the osteotomy site after surgically repositioning the distal segment 2. passively positioned the proximal segment without displacement of the condyle from its normal position.

Eligibility criteria:
inclusion criteria: * age of the patient between (18-60) years * patients in need of mandibular setback using bilateral sagittal split osteotomy. * all patients are free from any systemic disease that may affect normal bone healing. * patient with facial deformity will be treated with mandibular setback either mono or bimaxilary surgeries * patient with facial deformity will be treated with mandibular setback either surgery first approach or orthofirst approach. * sufficient dentition to reproduce the occlusal relationships * patient's consent to participate exclusion criteria: * patients with any systemic disease that may affect normal healing * intra-bony lesions or infections that may interfere with surgery. * previous orthognathic surgeries. * patients with all types of facial clefts

Keywords: mandibular setback low medial cut condylar position