cyrilzakka/clinical-trials huggingface dataset:
A Chart Review of Rituximab Plus Repeated Cycles of Dexamethasone

In this prospective and retrospective chart review, investigators will evaluate the response rates and duration of response for patients with relapsed and refractory idiopathic thrombocytopenic purpura (ITP) who have been treated with rituximab and repeated courses of dexamethasone. Investigators will also evaluate observed toxicities of the combination, and characteristics associated with response.

Patients with idiopathic thrombocytopenic purpura (ITP) usually respond with an increase in platelet count after treatment with steroids, but most patients will experience recurrence.Rituximab has been a useful treatment for patients with recurrent ITP; many hundreds of patients have been treated. 30-40% of patients will achieve a complete remission (CR: platelet count \>150 x 109/l) with initial treatment. However, most patients will relapse between 1 and 3 years from initial treatment suggesting that long-term "cures" only occur in 20% of the initial patients. An increased rate of durable CRs is therefore a desirable goal. One approach would be to use rituximab maintenance; however, this strategy results in long term B cell suppression. Dexamethasone has also been used to achieve "cure" in ITP, especially in adults at or near diagnosis. An initial study suggested that approximately 50% of patients would achieve a long-term response with only one 4-day cycle of high dose (40 mg/day) dexamethasone. A follow up study suggested that 3-4 cycles of dexamethasone would be better than 1 cycle. Finally, a recent publication suggested that rituximab plus one cycle of dexamethasone was superior to dexamethasone alone, with a \> 50% CR rate at 6 months. Based on the published activity of rituximab and dexamethasone in this disorder, some patients have received treatment with combined dexamethasone and rituximab. We will review the data of those patients who have received more than one course of dexamethasone together with rituximab for relapsed or refractory ITP in order to determine the response rate, duration of response, toxicity of the combination, and clinical predictors of response in this group.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects must be diagnosed with ITP.
2. Subjects must be 3 years old or older
3. Subjects must have a platelet count less than 40,000/uL at initiation of treatment regimen or inability to discontinue maintenance treatments such as intravenous immunoglobulin (IVIG), corticosteroids, azathioprine, and/or a thrombopoietin receptor agonist.

Exclusion Criteria:

1. Subjects who have not been diagnosed with ITP. 2 Subjects who are younger than 3 years old 3. Subjects who have a medical condition that would be adversely affected by high dose steroids
Consequence of Injectable Platelets Rich Fibrin Versus Microosteopeforation on Root Resorption During Orthodontic Intrusion of Incisor Teeth

Consequence of injectable platelets rich fibrin versus microosteopeforation on root resorption during orthodontic intrusion of incisor teeth

Consequence of injectable platelets rich fibrin versus microosteopeforation on root resorption during orthodontic intrusion of incisor teeth: A comparative clinical study

Eligibility Criteria:
Inclusion Criteria:

* 1. Patients with age range between 12-16 years. 2. Overbite \> 40% indicated for maxillary intrusion. 3. Mild to moderate crowding of upper incisors. 4. All permanent teeth erupted (excluding 3rd molars). 5. No previous orthodontic treatment. 6. Good oral hygiene with no previous periodontal surgery.

Exclusion Criteria:

1. - Transverse and/or vertical skeletal dysplasia or craniofacial malformation. 2. Retained primary or missing permanent teeth in the maxillary anterior area, and any kind of tooth/root shape anomaly.

3. Patients with root resorption, impacted canines, or dental anomalies. 4. Poor oral hygiene 5. Present or history of periodontal diseases. 6. Systemic diseases or regular use of medications that could interfere with orthodontic tooth movement.

7. History of trauma affecting the maxillary incisors. 8. Endodontically treated upper anterior teeth.
Neurocognitive Impairment in Patients With COVID-19

Delirium and acute neurocognitive impairment are increasingly observed in adult and pediatric patients with COVID-19. Prospective clinical studies combining clinical and laboratory examinations including specific biomarkers of neuroaxonal injury were not performed for COVID-19. The value of biomarkers of neuroaxonal injury was proven in preliminary studies. These biomarkers could thus contribute to the systematic detection of neurocognitive impairment in patients with COVID-19. Due to worldwide increasing numbers of hospitalized patients with COVID-19, biomarkers of neuroaxonal injury are highly valuable to detect and monitor cognitive impairment, especially with regard to limited resources available to perform time-consuming brain imaging.

Biomarkers of neuroaxonal injury are therefore not only of great interest to detect neurocognitive impairment but also to quantify the severity of brain injury in patients with COVID-19.

This is a multicenter observational study evaluating the incidence and severity of neurocognitive impairment in adult and pediatric patients with COVID-19. All study participants will be assessed by clinical and neurological examination as well as comprehensive laboratory tests using biomarkers of neuroaxonal injury at study day 1 (day of study inclusion), day 3, day 7 and day of hospital discharge. A panel of biomarkers (among others NSE, S100B and neurofilament proteins) will be measured. Clinical assessment will be performed using validated delirium tests (among others CAM-ICU, ICDSC) and scales to assess the neurocognitive performance of study participants before and three months after study inclusion (among others Short Blessed Test).

A group of patients with a comparable severity of disease but without the detection of SARS-Cov-2 will serve as control group and will undergo the same clinical and laboratory examinations.

We hypothesize, that:

* patients with COVID-19 are more likely to develop delirium and neurocognitive impairment than patients without COVID-19
* patients with a preexisting neurocognitive deficit are more vulnerable to neurocognitive impairment in the course of COVID-19 than patients without a preexisting neurocognitive deficit
* Specific biomarkers of neuroaxonal injury correlate with the clinical severity of acute neurocognitive impairment and can predict the 3-month neurocognitive outcome of patients with COVID-19

Eligibility Criteria:
Inclusion Criteria:

* adult patients of every age
* admission to hospital with suspected COVID-19 disease
* confirmed SARS-CoV-2 infection within 48 hours after admission

Exclusion Criteria:

* transferral from another hospital
* other acute central nervous system diseases (e.g. meningoencephalitis, intracerebral ischemia or hemorrhage)
* confirmed SARS-CoV-2 infection later than 48 hours after hospital admission
* participation in another interventional study
* no written informed consent from patient or legal representative
An Intervention to Reduce Sedentary Behavior for Black Adults With Chronic Kidney Disease

RESET-CKD is evaluating an intervention to support Black adults with chronic kidney disease (CKD) to reduce their sedentary (e.g., sitting) time. Half of the participants will be randomized to the intervention, where the goal is to support individuals to reduce their sitting time, and the other half will be randomized to an attention control condition that provides CKD-related education not related to sedentary behavior. All participants will be followed for 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Self-identifies as Black or African American
* Age ≥35 to ≤80 years old
* CKD Stage 1-4
* Self-reported 6 or more hours/day of sedentary time
* Ability to speak/read/understand English
* Has access to a telephone

Exclusion Criteria:

* Being unable to walk 1 block
* Being unable to stand from a seated position without assistance
* Using a wheelchair, walker, or cane for all of their ambulation
* Presence of a condition(s) or diagnosis, either physical or psychological, that precludes participation, including: Lower-extremity amputation (AKA or BKA) without prosthetic, Orthopedic condition that would preclude prompted sit-to-stand transitions or standing, Neurologic or psychiatric condition that would preclude prompted sit-to- stand transitions or standing, Severe cognitive impairment, Unstable coronary artery disease (i.e., angina with activity), Orthostatic hypotension
* Kidney transplant
* Any other condition that the investigator considers precludes participation in the trial
* Participated in the Patient Advisory Board
Initial Study With the CNDS Advanced Cervical Scan to Recalibrate Spectral Data for Use in Future Screening Studies

The purpose of this study is to evaluate whether fluorescence and reflectance spectroscopy can improve the ability to detect the presence of premalignant lesions on the cervix.

Subjects (approximately 500) will be initially enrolled from a general screening population in the first phase, and during the second phase from the colposcopy clinic population (approximately 300) based on their referral abnormal Pap cytology conducted within 120-days in order to achieve a statistically viable number of normal women, women with Cervical Intra-epithelial Neoplasia (CIN1/2) and women with CIN3+, as described in Section 6.1, "Cervical Cytology Enrollment Targets". After the Cervical Neoplasia Detection System (CNDS) test, a sample for Hybrid Capture 2 Human papillomavirus (HPV) testing and liquid cytology will be collected in addition to colposcopy and biopsy, if indicated.

A key component of effective screening studies designed to evaluate new detection modalities is verification of the gold standard comparison by which estimates of sensitivity and specificity are generated. In the case of screening studies in general and studies of cervical disease detection in particular, the avoidance of verification bias is a priority. For the purposes of the proposed study, CIN3 or cancer (CIN3+) must be verified or adjudicated by multiple histopathologists. Results for women with CIN1 or CIN2 will be confirmed histopathologically and analyzed as a separate subgroup because these lesions often regress to normal in certain populations and tend to cause disagreement among histopathologists. In order to verify absence of disease (i.e., CIN1 or less severe), the investigators will not rely on histopathology, as it would not be ethical to perform multiple biopsies or excisional procedures to obtain a tissue sample for histopathology. Instead, women will be considered normal if they have negative referral cytology, are free of high risk HPV and are colposcopically normal.

Eligibility Criteria:
Inclusion Criteria:

* Age 21 or above
* Able to read or understand and give informed consent
* Negative pregnancy test or documentation of acceptable birth control
* Willing to undergo colposcopy, cytology (if required) and HPV testing on day of study
* Abnormal cytology result within 120 days of CNDS test for Phase 2 subjects

Exclusion Criteria:

* Pregnancy
* Menstruating
* Previous cervical neoplasia
* Prior hysterectomy
* Conditions relating to the cervix that would render the test difficult to perform, including but not limited to:

Excessive blood or mucus that cannot be removed Abnormal congenital cervix Unable to tolerate speculum or CNDS single use cervical guide
A Study to Evaluate the Safety and Immunogenicity of GSK Biologicals' Seasonal Influenza Vaccine in Adults

This study is designed to test the immunogenicity and reactogenicity of the Fluarix™/Influsplit SSW® influenza vaccine containing the influenza strains recommended for the 2010-2011 season.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who the investigator believes that they can and will comply with the requirements of the protocol should be enrolled in the study.
* A male or female aged 18 years or above at the time of the vaccination.
* Written informed consent obtained from the subject.
* Healthy subjects or with well-controlled chronic diseases as established by medical history and clinical examination before entering into the study.
* If the subject is female, she must be of non-childbearing potential or if she is of childbearing potential, she must practice adequate contraception for 30 days prior to vaccination, have a negative pregnancy test and continue such precautions for 2 months after completion of the vaccination series.

Exclusion Criteria:

* Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the vaccination or planned use during the study period.
* Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose.
* Administration of immunoglobulins and/or any blood products within the three months preceding the administration of the study vaccine or planned during the study.
* Administration of an influenza vaccine within 6 months preceding the study start.
* Administration of an influenza vaccine other than the study vaccine during the entire study
* Clinically or virologically confirmed influenza infection within 6 months preceding the study start
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
* Acute disease at the time of enrolment.
* Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
* Not stabilized or clinically serious chronic underlying disease.
* Lactating female.
* History of chronic alcohol consumption and/or drug abuse.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
* Any condition which, in the opinion of the investigator, prevents the subject from participation in the study.
Safety and Tolerability Study of rBet v1 SLIT Tablets

The purpose of this study is to determine the safety and tolerability of several doses of r Bet v1 administered as sub-lingual tablets in subjects sensitised to birch pollen.


Eligibility Criteria:
Inclusion Criteria:

* written consent
* Male or female subject from 18 to 60 years old and in general good health
* For woman of child bearing potential:
* Symptoms of birch pollen induced allergic rhinitis for at least the last 2 years.
* Sensitisation to birch pollen as demonstrated with a positive SPT to birch pollen and specific IgE level (birch pollen and r Bet v1) \>0.70 kU/L at screening.
* FEV1 at least of 80% of predicted values at screening.
* Subject accepting to comply fully with the protocol.

Exclusion Criteria:

* Past or current disease which as judged by the Investigator, may affect the outcome of this study.
* History of life-threatening asthma,
* Asthma requiring daily treatment (whatever the pharmaceutical class).
* Pregnant or lactating woman.
* Subject being treated with inhaled steroids within 4 weeks prior to screening visit or within 12 weeks prior to screening visit.
* Subject who previously received desensitisation treatment to birch pollen and/or other betulaceae (e.g., hazel tree, alder) or who plan to start desensitisation treatment during this study.
* Symptoms during the treatment phase due to a sensitivity to a second allergen.
* Subjects treated with ongoing immunotherapy with another allergen
Diet/Growth Factor Mechanisms of Gut Adaptation

This is a double-blind randomized controlled study on the clinical and metabolic effects and underlying gut mucosal mechanisms of modified diet, with or without recombinant human growth hormone, in adults with severe short bowel syndrome dependent upon parenteral nutrition. Clinical endpoints include ability to wean patients from parenteral feeding, metabolic endpoints include gut nutrient absorptive function and molecular endpoints include expression of growth factors and nutrient transporters in small bowel and colonic mucosa. The 6-month study is performed, in part, in the General Clinical Research Center for inpatient stays and outpatient visits.

This is a double-blind randomized controlled study on the clinical and metabolic effects and underlying gut mucosal mechanisms of modified diet, with or without recombinant human growth hormone, in adults with severe short bowel syndrome dependent upon parenteral nutrition. Clinical endpoints include ability to wean patients from parenteral feeding, metabolic endpoints include gut nutrient absorptive function and molecular endpoints include expression of growth factors and nutrient transporters in small bowel and colonic mucosa. The 6-month study is performed, in part, in the General Clinical Research Center for inpatient stays and outpatient visits.

Eligibility Criteria:
* Parenteral nutrition-dependent adults with short gut syndrome.
* Patients must not have diabetes mellitus or active malignancy within the past 5 years.
Chen's U-Suture Technique for Pancreaticojejunostomy Following Pancreaticoduodenectomy

To date, pancreaticoduodenectomy (PD) is the only recognized potentially curative therapy for malignant neoplasms located in the peri-ampullary region, and is increasingly being used for the treatment of cancer through the resection of the premalignant precursors for invasive carcinomas.Postoperative pancreatic fistula (POPF) is one of the most common complications associated with substantial clinical implications following PD, which significantly affects mortality rate, length of hospital stay, and overall hospital costs. Therefore, the prevention of POPF has always been a high priority for our group as well as other international surgical groups. In 1995, investigators' group established the Chen's U-stitch approach, which was a new technique of end-to-end invaginated pancreaticojejunostomy with transpancreatic transverse U-sutures after PD, and the preliminary results were quite encouraging at that time. Thus, investigators intend to conduct a multicentre, randomized, parallel-group controlled, clinical trial to evaluate the effect and safety of the new technique.

This is a multicentre, randomized, parallel-group controlled, clinical trial to evaluate the effect and safety of Chen's U-Suture technique for pancreaticojejunostomy following pancreaticoduodenectomy. Investigators plan to enroll 960 patients in this study and eligible patients will be randomly divided into two groups. One group will use Chen's U-Suture technique and other group will use classic duct-to-mucosa technique. All patients will be followed up for 3 month after surgery, and primary outcome is POPF, other outcome such as duration of operation, grade of POPF, morbidity, mortality, length of hospital stay, reoperation rate, postoperative pancreatic function and postoperative incidence of chronic pancreatic diseases.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female, 18 to 75 years of age, inclusive.
2. Patients have a diagnosis of benign and malignant diseases of the pancreatic head and periampullary region and requiring pancreaticoduodenectomy.
3. Patients have not been treated with any anticancer medications and immunotherapy prior to surgery
4. Patients have not been accompanied by serious physical diseases of heart, lung, brain, etc., and can generally tolerable for surgery.
5. Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

1. Female subjects who are pregnant or breastfeeding.
2. Patients scheduled to undergo pancreatogastrostomy.
3. Patients whose pancreatic duct cannot be located.
4. Patients with history of previous pancreatic surgery, server acute or chronic disease or surgical contraindication.
5. Patients with HIV-infectious or other AIDS-related disease.
6. Patients have any condition that in the judgement of the Investigators would make the subject inappropriate for entry into this study.
Ragweed Observational Study

This is an observational to evaluate Total Rhinoconjunctivitis Symptom Score and rescue medication usage (as measured by Rescue Medication Score as a Combined Score to inform the design of a phase III field study with ToleroMune Ragweed.


Eligibility Criteria:
Inclusion Criteria

* Male or female, aged 18-65 years.
* Reliable history of rhinoconjunctivitis and/or rhinoconjunctivitis plus controlled asthma on exposure to ragweed allergen for at least 2 years and required symptomatic treatment for at least 1 year.
* Positive skin prick test (SPT) to Ambrosia artemisiifolia
* Specific Immunoglobulin E (IgE) against Ambrosia artemisiifolia \>0.35 kU/L

Exclusion Criteria

* Positive skin test to any confounding, co-existing seasonal allergens likely to be present during the Pre-season baseline and ragweed pollen periods (grasses, miscellaneous weeds, fall trees) and who have received medication for these confounding seasonal allergies.
* Medical records of symptomatic perennial allergic rhinitis and/or asthma due to an allergen to which the subject is regularly exposed (moulds, dust mites, cockroaches, and animal dander) and have received medication for these perennial allergies
* Subjects with a history of severe drug allergy, severe angioedema or anaphylactic reaction to food or previous SPT for any allergen.
* Subjects with a history of any significant disease or disorder (e.g., cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, immunopathological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment) which, in the opinion of the Investigator, may influence the subject's ability to participate in this study.
Evaluation of Effectiveness and Safety of Hybrid Coronary Revascularization

This study evaluated the effectiveness and safety of Hybrid Coronary Revascularization in real-world practice.


Eligibility Criteria:
Inclusion Criteria:

* Age 20 and more
* Hybrid coronary revascularization due to multivessel coronary artery disease(must include left anterior descending artery)
* Written consent

Exclusion Criteria:

* Previous CABG(coronary artery bypass graft)
* Life expectancy ≤1 year