Kornimate/medical-research-clean huggingface dataset:
a clinical trial of patients with solid tumours receiving granulocyte colony stimulating factor as primary prophylaxis for chemotherapy-induced neutropenia, in a docetaxel based regimen

Conditions: Neoplasms (no Otherwise Specified)

Summary: primary objective: to evaluate the incidence and severity of neutropenia in patients being treated for solid tumours with a taxotere® based regimen when granocyte® 34 is being used as a primary prophylaxis for chemotherapy-induced neutropenia. secondary objectives: haematological : to evaluate the incidence and severity of febrile neutropenia (with or without antibiotics) and anaemia in patients being treated for solid tumors treated with a taxotere based regimen when granocyte is being used as a primary prophylaxis. non-haematological : to evaluate the incidence and severity of the following adverse events: asthenia, anorexia, myalgia, nail changes and oral mucositis in patients with solid tumours treated with a taxotere based regimen; when granocyte is being used as a primary prophylaxis.


Eligibility criteria:
inclusion criteria: * patients willing to sign informed consent prior to entry into the study, * patients who have been prescribed a taxotere based regimen, * patients who have not yet started with the first taxotere treatment, * patients with a histological diagnosis of one of the following solid tumours: breast cancer, non-small cell lung cancer (nsclc), ovarian cancer, prostate cancer, gastric cancer or head and neck cancer. exclusion criteria: * patients who are enrolled in another clinical study, * pregnant and/or breastfeeding patients, including women of childbearing potential not willing to use medically acceptable methods of contraception, * patients with severe liver impairment, * patients with severe renal function impairment, * patients with a known hypersensitivity to granocyte 34 or its constituents, * patients with a history of severe hypersensitivity reactions to taxotere or polysorbate 80, * patients with a baseline neutrophil count of \< 1500cells/mm3, * patients on other drugs that are contra-indications for the use with taxotere, * patients on con-current radiotherapy. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
impact of tensor fascia lata stretch on vastus medialis obliqus activity

Conditions: Patellofemoral Pain Syndrome

Summary: patellofemoral pain syndrome (pfps) is one of the most typical causes of anterior knee pain in adolescents and young adults under the age of 50.it is believed that imbalanced action between quadriceps components, is the most contributing cause of pfps.investigating exercises that increase vmo muscle activation and enhance the ratio between vmo and vl have been a standardized target in literature.

participants will have the assessed limb ready by shaving the hair on thigh and using alcohol swabs to clean the area from any residues. for the vmo, a surface emg electrode will be placed 4 cm superior and 4 cm medial to the supromedial boarder of patella at approximately 55 degrees to the long axis of the femur. as for the vl, the electrode will be placed 10 cm superior and 6-8 cm lateral to the superior lateral boarder of the patella and orientated 15 degrees to the vertical. all electrodes are self-adhesive (figure 8) and will be connected to emg sensors that will be attached and secured by double-sided tape.each participant will perform three consecutive squats with 5 seconds interval break between each repetition. the squat depth will be kept at 50 degrees knee flexion. mean muscle activity from three squat repetitions of vmo and vl is recorded and vmo:vl ratio is calculated. afterward, each participant will perform the tfl stretch and repeat the three squats again.

Eligibility criteria:
inclusion criteria: 1. both genders. 2. body mass index (bmi) ranges from 18.5 to 29.9. 3. age ranges between 18 and 30 years old. 4. experience nontraumatic anterior knee pain. 5. pain with any two activities, including running, jumping, squatting, kneeling, stair ascent/descent or prolonged sitting. 6. having at least one positive pfps clinical tests including, patellofemoral compression, patellofemoral gliding or resistive quadriceps setting exclusion criteria: 1. coexisting pathology around the knee, including patellar subluxation or dislocation. 2. previous knee surgery. 3. suspicion of patellar tendinopathy, with strong consideration of pain localised to the patellar tendon. 4. patients didn't receive physiotherapy treatment or use of non-steroidal anti-inflammatory drugs for knee pain in the previous 3 months. 5. any neurological or rheumatic disorders 6. pain intensity more than 5 (based on visual analogue scale) 7. hip and ankle pathology. 8. bmi more than 30%. 9. pregnancy.
assessment of netosis during covid-19, under treatment with anakinra, an interleukin-1 receptor antagonist

Conditions: Covid19

Summary: during their activation in response to an infectious stimulus or during chronic inflammatory processes, blood and tissue neutrophils modify their functional phenotype and produce numerous toxic mediators. in particular, they rapidly release chromatin filaments covered with numerous granular and cytoplasmic components called "neutrophil extracellular traps" (nets). this phenomenon, called netosis, has been implicated in many diseases, in particular in viral infections during which this response can be useful for the anti-infectious response at the initial phase, then deleterious when it becomes toxic. for the tissue environment. this has been shown in particular during post-pneumonia acute respiratory distress syndrome. the intensity of netosis is therefore an early factor in activating neutrophils and inflammation. given the major biological signs of inflammation observed in patients with covid-19 as soon as they enter the hospital \[c-reactive protein (crp), interleukin-6 (il-6), d-dimers, etc.), it seems particularly interesting to better document this inflammation.


Eligibility criteria:
inclusion criteria: * patients aged ≥ 18 years * patients hospitalized within the paris saint-joseph hospital group for whom the diagnosis of covid-19 has been established on the basis of a pcr positive for sars-cov 19 using a nasal swab and/or a typical chest ct scan * patients with a severe or aggravating form of covid-19, based on an oxygen saturation ≤93% under 6 l/min of nasal oxygen or a saturation ≤93% under 4 l/min oxygen with a decrease in saturation of at least 3% during the last 24 hours, in ambient air * patients treated with anakinra * patients for whom il-6 assays have been performed * french speaking patients exclusion criteria: -
dimensional changes in single crowns supported by short transmucosal implants with diverging or converging neck profiles in the esthetic zone

Conditions: Edentulous Alveolar Ridge

Summary: the goal of the present randomized clinical trial is to assess the long-term osseous and peri-implant soft tissue changes as well as the success rate of short implants (6 mm) with a converging collar with micro threads or a diverging polished collar placed in the esthetic zone of the maxilla on partially edentulous patients. the main questions it aims to answer are: * what are the long-term bone and soft tissue changes around implants with a converging collar with micro threads compared to a diverging polished collar placed in the esthetic zone of the maxilla? * what is the success rate of implants with a converging collar with micro threads compared to a diverging polished collar placed in the esthetic zone of the maxilla? dental implants with a converging collar with micro threads or a diverging polished collar will be placed in the esthetic zone of the maxilla of the included participants and the measurements regarding the bone and soft tissue level will be compared.

the objectives of the present randomized clinical trial are to evaluate the clinical and radiographic changes over time of hard and soft tissues around implants with a convergent or divergent collar. twenty volunteer participants with two edentulous regions in the maxillary esthetic zone (from the right second premolar to the left second premolar) will be included in the study. two implants will be randomly installed, one with a convergent collar and one with a divergent collar. after 3 months of healing, individual crowns will be installed. at each visit the following parameters will be evaluated: plaque index, probing depth, bleeding on probing, the recession of the mucosal margin, intraoral radiographs, likewise control cbct, and impressions will be performed. the visit will take place at 6 and 12 months and then annually for a minimum of 3 years. changes at the level of the marginal bone will be assessed overtime on the radiographs. dimensional changes will be clinically evaluated during control evaluations and later through digital impressions.

Eligibility criteria:
inclusion criteria: * presence of at least two edentulous areas in the esthetic region of the maxilla (from right to left from second premolar to premolar, preferably first premolars and incisors) * alveolar bone ≥ 8 mm in height and ≥ 5 mm in thickness assessed on cbct. * age of ≥ 21 years. * need for an implant-supported prosthetic restoration. * be in good general health with no contraindications to oral surgical procedures. * not be pregnant. * patients who agree to participate in the study and sign the informed consent. exclusion criteria: * the presence of any uncontrolled systemic disease. * history of past or ongoing chemotherapeutic or radiotherapeutic treatments. * heavy smokers (\>10 cigarettes per day). * previous bone regeneration procedures in the area of interest

Keywords: maxilla partially edentulous dental implant implant supported prosthesis
curian s. pneumo/legionella assay beta clinical trial protocol

Conditions: Streptococcus Pneumoniae Infection; Legionella Pneumophila Serogroup 1 Infection

Summary: beta trial to evaluate the preliminary clinical performance of the curian s. pneumo/legionella assay for its use in the qualitative detection of streptococcus pneumoniae and/or legionella pneumophila serogroup 1 antigens in human urine specimens.

this study will evaluate the preliminary clinical performance of the ruo curian s. pneumo/legionella assay against two fda cleared comparators for its use in the qualitative detection of streptococcus pneumoniae and/or legionella pneumophila serogroup 1 antigens in human urine specimens.

Eligibility criteria:
inclusion criteria: * adult males and females, with symptom of pneumonia and for whom a streptococcus pneumoniae and/or legionella pneumophila serogroup 1 diagnostic test has been ordered by a practicing physician. * at least 2ml of urine from fresh de-identified clinical specimen from standard of care lab testing * only one (1) specimen per patient will be included in the study * materials used within their expiration date * storage time and conditions within requested indications listed on ruo package insert exclusion criteria: * specimens from patients for whom a streptococcus pneumoniae and/or legionella pneumophila serogroup 1 diagnostic test has not been ordered * storage times and conditions that exceed these study protocol requirements listed on ruo package insert * urine samples provided in unsatisfactory conditions
study of difluprednate ophthalmic emulsion in the treatment of severe uveitis

Conditions: Uveitis; Panuveitis

Summary: the purpose of this phase 3 open-labeled study is to determine if difluprednate ophthalmic emulsion is effective in the treatment of severe uveitis.

the objective of this phase 3 study is to assess the efficacy and safety of 0.05% difluprednate ophthalmic emulsion in patients with severe endogenous anterior uveitis with an open-labeled, no-controlled and no-randomized design.

Eligibility criteria:
inclusion criteria: * patients with a diagnosis of endogenous anterior uveitis or panuveitis * patients with ≥ 50 anterior chamber cells as observed by slit lamp microscopy (criterion for evaluation of signs 4) * patients requiring more frequent instillation of 0.1% betamethasone sodium phosphate ophthalmic solution than the regular frequency specified in its dosage and administration (3 - 4 times/day) * patients aged ≥ 12 years (on the day of obtaining informed consent) who were able to actuate symptoms * patients giving written informed consent prior to initiation of the study exclusion criteria: * patients who did not meet all of the above inclusion criteria * patients initiating treatment with systemic administration of any corticosteroid, non-steroidal anti-inflammatory drug, antiphlogistic enzyme or immunosuppressive drug within 2 weeks before instillation of the investigational drug * patients receiving topical injection of any corticosteroid in eyes before instillation of the investigational product(solution formulation: within 1 week before instillation of the investigational product, depot formulation: within 2 weeks before instillation of the investigational product) * patients receiving instillation of any corticosteroid, non-steroidal anti-inflammatory ophthalmic solution or antiphologistic enzyme within 12 hours before instillation of the investigational drug * patients with glaucoma or ocular hypertension * patients with corneal erosion or corneal ulcer * patients with any viral, bacterial or fungal keratoconjunctival disease or suspected with eye infection * patients with allergy to similar drugs of difluprednate * patients requiring use of contact lens during the study period * women who were or might be pregnant, or lactating women * patients participating in another clinical study within 3 months before initiation of the present study
a study to evaluate the clinical efficacy and safety of subcutaneously administered c1-esterase inhibitor in the prevention of hereditary angioedema

Conditions: Hereditary Angioedema Types I and II

Summary: the aim of this study is to assess the efficacy of c1-esterase inhibitor in preventing hereditary angioedema attacks when it is administered under the skin of subjects with hereditary angioedema. the safety of c1-esterase inhibitor will also be assessed. each subject will enter a run-in period of up to 8-weeks. subjects who complete the run-in period and who are eligible will then enter the treatment phase which comprises two sequential treatment periods. in the treatment phase, subjects will be randomized to one of four arms consisting of treatment with low- or higher-volume c1-esterase inhibitor in one treatment period and treatment with low- or higher-volume placebo in the other treatment period. the study will measure the number of hereditary angioedema attacks that subjects experience while receiving each treatment.


Eligibility criteria:
inclusion criteria: run-in period inclusion criteria: * males or females aged 12 years or older. * a clinical diagnosis of hereditary angioedema type i or ii. * hereditary angioedema attacks over a consecutive 2-month period that required acute treatment, medical attention, or caused significant functional impairment. * for subjects who have used oral therapy for prophylaxis against hae attacks within 3 months of screening: use of a stable regimen within 3 months of screening, with no plans to change. eligibility criteria for entering treatment period 1: * laboratory confirmation of type i or type ii hereditary angioedema, including c1-esterase inhibitor functional activity less than 50% and c4 antigen level below the laboratory reference range. * no clinically significant abnormalities as assessed using laboratory parameters. * during participation in the run-in period, subjects must have experienced hereditary angioedema attacks that required acute treatment, required medical attention, or caused significant functional impairment. exclusion criteria: run-in period exclusion criteria: * history of clinical significant arterial or venous thrombosis, or current history of a clinically significant prothrombotic risk. * incurable malignancies at screening. * any clinical condition that will interfere with the evaluation of c1-esterase inhibitor therapy. * clinically significant history of poor response to c1-esterase therapy for the management of hereditary angioedema. * receiving therapy prohibited by the protocol, including medications for hereditary angioedema prophylaxis. * female subjects who started taking or changed dose of any hormonal contraceptive regimen or hormone replacement therapy (i.e., estrogen/progesterone-containing products) within 3 months prior to the screening visit.

Keywords: hereditary angioedema
mechanisms of anxiety and depression study

Conditions: Depression; Anxiety

Summary: eligible participants will come in for three separate visits in which they will be interviewed, perform a variety of tasks, and undergo a non-invasive mri scan. the investigators anticipate that (1) participants with anxiety and depression will likely perform differently than the healthy controls on cognitive tasks, (2) participants with anxiety and depression will likely show differences in brain functionality compared to the healthy controls, and (3) depression and anxiety likely share some underlying mechanisms.

in order to determine eligibility, a brief phone screen lasting approximately 15 minutes will be conducted. if participants are eligible, they will be asked to come in for three separate visits. during the first visit, participants will complete questionnaires as well as a structured interview with one of the study's staff members at palo alto university in los altos. during the second visit, participants would come to palo alto university in los altos and complete questionnaires as well as a testing session involving various tasks. during the third visit, participants would undergo a non-invasive brain scan in which participants would complete a task as well as various questionnaires at stanford university in stanford. the investigators have flexible hours and can work around participants' schedules! to inquire more about participation, participants can either email the investigators at paloalto.study@gmail.com or call the investigators at (650) 417-2000 ext. 3642

Eligibility criteria:
inclusion criteria: * right-handed * healthy with no medical conditions or have a history of anxiety and/or depression * ability to travel to both palo alto university and stanford university
cattell-warren versus blumgart techniques of pancreatico-jejunostomy following pancreato-duodenectomy

Conditions: Pancreatic Cancer

Summary: the purpose of this study is to compare two different techniques of performing a pancreatic anastomosis; cattell-warren versus blumgart to determine if a blumgart anastomosis reduces pancreatic remnant leak, post-operative complications and overall length of hospital stay.

this is a randomised controlled, phase iii, double blinded, multicentre clinical trial comparing cattell-warren (cwa) versus. blumgart (ba) methods of pancreaticojejunostomy following pancreaticduodenectomy for supected malignancy of the pancreatic head. the primary objective of the trial is to establish if the blumgart anastomosis reduces pancreatic remnant leak and in turn complications, hospital stay, cost and promote enhanced recorvery programs. 506 patients (253 patients per treatment arm) will be recruited from approximately 7 centres throughout the united kingdom. patients recommended for resection who provide written informed consent will be randomised to one of the following treatment arms on the day of surgery by the surgeon: arm a: blumgart method of panreaticojejunostomy. arm b: cattellwarren method pf pancreaticojejunostomy. randomisation will be undertaken intra-operatively, following pancreatic head excision, just prior to pancreatic head remnant reconstruction. patients will be assessed post operatively on days 3 to 7 and on day of dishcharge from hospital. patients will continue to be followed up in the outpatient setting at 3, 6 and 12 months post surgery. all laboratory and physical assessments performed will be in line standard care. blood samples for the translational study will be taken subject to informed consent pre-operatively and post-operatively 5 days after surgery. a histological (h\&e stained) slide of the pancreatic transection margin should be taken as routine. this will be requested from each patient for central pathology review to assess the amount of fibrosis.

Eligibility criteria:
inclusion criteria: * patients undergoing an elective pancreato-duodenectomy for presumed malignancy. * ability of the subject to understand the nature and consequences of the trial. * ability to rovide writen informed consent. * age 18 or greater. exclusion criteria: * patients undergoing extended pancreato-duodenectomy * left, central or total pancreatectomy. * arterial resection or multi-visceral resection * previous pancreatic surgery * surgery for known chronic pancreatitis. * recruited to any other pancreatic resection trial. * pregnant women. * women of childbearing potential, including women whose last menstrual period was less than one year prior to screening, unable or unwilling to use adequate contraception from time of consent up to the day of surgery.

Keywords: pancreatico-jejunostomy pancreato-duodenectomy cattell-warren anastomosis blumgart anastomosis
non-invasive diagnosis of portal hypertension with acoustic radiation force impulse (arfi)

Conditions: Portal Hypertension; Chronic Liver Disease

Summary: the aim of this diagnostic study is to evaluate the efficacy of arfi imaging (a specific type of ultrasound) in assessing the pressure of the portal vein (the major vein passing through the liver) and the amount of liver fibrosis in patients with chronic liver disease.

design the study is designed as a prospective, cross-sectional, diagnostic study in which the investigators will evaluate the use of arfi to diagnose clinically significant portal hypertension (csph defined as hepatic veous pressure gradient (hvpg)greater than 10 mmhg), taking hvpg measurements as gold standard. methodology * the study will be performed at the va connecticut healthcare system-west haven and yale. * study population will be recruited among patients from the va/yale liver clinics or outside hospitals that are referred to va/yale for a transjugular liver biopsy and hepatic venous pressure gradient measurement as part of their routine care.

Eligibility criteria:
inclusion criteria: * age 18-85 years * compensated chronic liver disease with suspected or confirmed liver cirrhosis sent for transjugular liver biopsy as part of their routine care * signed informed consent exclusion criteria: * known contraindications to the performance of an hvpg measurement or a trans-jugular biopsy * portal thrombosis * previous surgical or transjugular portosystemic shunt * previous total or partial splenectomy * presence of comorbid conditions conferring a life expectancy of less than 1 year

Keywords: portal hypertension cirrhosis arfi diagnostic study