cyrilzakka/clinical-trials huggingface dataset:
PEG-ASP, Etoposide and Gemcitabine for Natural Killer/T Lymphoma

Extranodal natural killer/T-cell lymphoma (ENKTL) is an aggressive form of non-Hodgkin's lymphoma and shows extremely poor survival. This prospective pilot study to evaluate the efficacy and safety of pegylated aspargase(PEG-ASP)combined with etoposide and gemcitabine (PEG) treatment in this population.

Treatment PEG dosages were as follows: days 1 and 8,30min intravenous infusion of 1000mg/m2 gemcitabine;day1,4h intravenous infusion of 100mg/m2 etoposide,day1-3,deep intramuscular injection of 2500unit/m2 PEG-ASP at three different sites.The regimen was repeated every 3 weeks.Stage IE/IIE patients underwent four cycles induction chemotherapy, followed by involved-field radiotherapy after got complete remission ,partial regression or stable disease.Three-dimensional conformal radiotherapy was done by linear accelerator at 2.0 grays (Gy) per daily fraction with 5-6 weeks. The involved-field radiation (IFRT) dose was 50-56 Gy.Stage IIIE/IVE patients were given for a maximum of six cycles.Refractory/relapsed patients underwent at least two cycles treatments unless there was disease progression or unacceptable side effects, or withdrawal of patient consent. Autologous haematopoietic stem cell transplantation (AHSCT) was recommended after achieving CR for advanced stage and refractory/relapsed patients

Eligibility Criteria:
Inclusion Criteria:

1. pathologically confirmed, previously untreated or refractory/relapsed ENKTL as defined by the World Health Organization classification;
2. age≥18 years;
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2;
4. at least one measurable lesion;
5. adequate haematologic function (haemoglobin \> 9.0 g/l, absolute neutrophil count \> 1500/ml, platelets \> 75,000/l),
6. adequate hepatic function (total serum bilirubin ≤ 1.5 times the upper limit of normal, alanine aminotransferase and aspartate aminotransferase ≤ 2.5 times the upper limit of normal),
7. adequate renal function (serum creatinine ≤ 1.5 mg/dl, creatinine clearance ≥ 50 ml/min);
8. normal coagulation function and electrocardiogram results.
9. Prior chemotherapy and radiotherapy should have been completed \>4 weeks 10.earlier,willingness to provide written informed consent.

Exclusion Criteria:

-
AMI Construction in Lower Extremity Residual Limbs

This study will involve the development of a novel approach to lower extremity residual limb surgical revision that offers the promise of augmenting volitional motor control, restore proprioception and reverse atrophy

The hypothesis of this research protocol is that we will be able to modify the residual limbs of patients who have already undergone lower extremity amputations so as to include biological actuators that will enable the successful employment of next generation lower extremity prostheses, diminish/eliminate phantom limb pain, restore proprioception and regenerate lost muscle mass. The specific aims of the project are as follows:

1. To develop a standardized operative technique for both above knee (AK) and below knee (BK) amputation revision procedures that includes AMIs to restore musculotendinous proprioceptive capabilities
2. To assess the capacity for these actuators to provide enhanced motor control and sensory feedback, as well as ablate phantom limb symptomatology and augment residual limb muscle mass
3. To determine the reinnervation time course and longevity of these biological constructs
4. To validate the functional and somatosensory superiority of the proposed revision technique over standard approaches to BKA and AKA
5. To develop a modified acute postoperative rehabilitation strategy suited to this new surgical approach

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18-65
* Has already undergone a standard AKA or BKA procedure
* Suffers from symptoms such as:

  * Intractable pain
  * Deterioration of skin on or around stump
  * Suffering from other sources of discomfort arising from stump
* Intact inherent wound healing
* Adequate communication skills
* High motivation

Exclusion Criteria:

* Inadequate health to undergo operative procedure using standard anesthesia (i.e. cardiopulmonary)
* Individuals with impaired wound healing
* Individuals suffering from extensive peripheral neuropathies
* Active smokers
* Individuals with a history of poor compliance
* Women who are pregnant or plan to become pregnant before surgical intervention
Effect of Turmeric on Pruritus in Hemodialysis Patients

The purpose of this study is to see whether turmeric can be effective in treatment of pruritus in hemodialysis patients.

pruritus is a common in hemodialysis patients and many treatment recommended for it . as turmeric has anti-inflammatory , anti-cytokine and anti-oxidant effect it may effective in treatment of uremic pruritus. thus we compared turmeric with placebo in this study

Eligibility Criteria:
Inclusion Criteria:

* Hemodialysis for more than 3 months
* More than 18 years old
* Pruritus

Exclusion Criteria:

* Use other treatment for pruritus
The Role of Licensing in Early Care and Education: Front-Line Licensing Staff

Child Trends, funded by the Office of Planning, Research, and Evaluation, Administration for Children and Families (ACF) in the U.S. Department of Health and Human Services (HHS) will collect descriptive information for The Role of Licensing in Early Care and Education (TRLECE): Front-Line Licensing Staff project. The goal of this information collection is to deepen the field's understanding of child care and early education licensing systems, which play a critical role in supporting positive outcomes for providers, families, and children. The investigators will conduct one round of survey data collection with front-line child care licensing staff in all states.

This study aims to advance understanding of the landscape of child care and early education licensing systems. State/territory child care and early education licensing agencies establish and monitor regulations that child care programs serving young children must meet to operate legally. These regulations and monitoring practices play a large role in the operations of child care programs but have received relatively little research attention. The field has limited information about features of state/territory licensing units; and no information directly from front-line licensing staff about their characteristics, experiences, training, and perceptions of licensing. Ultimately, TRLECE: Front-Line Licensing Staff findings can inform licensing policies, practices, and supports in the child care and early education field; guidance and technical assistance to state leaders; and future research.

The investigators will conduct a survey of front-line child care licensing staff, who are the individuals who routinely conduct inspections of licensed child care programs, for this descriptive study. The survey is designed to collect information about front-line staff members' roles, day-to-day responsibilities, demographic characteristics, career paths, professional development experiences, relationships with colleagues and providers, and burnout/work satisfaction, role in supporting quality and quality improvement, and perceptions of strengths and challenges of the licensing system. The investigators intend to invite all front-line staff from all 50 states and DC to participate (n=\~3,000).

Eligibility Criteria:
Inclusion Criteria:

* All front-line child care licensing staff in all U.S. states and DC

Exclusion Criteria:

* Individuals who are not front-line child care licensing staff in U.S. states and DC
Prevalence of Peripheral Vascular Diseases and Presentation in Patients With Autoimmune Diseases

Rheumatic autoimmune diseases include conditions such as systemic lupus rheumatoid arthritis systemic sclerosis in which connective tissues are frequently targeted.

Autoimmune diseases as a group are among the leading causes of death and morbidity in the industrial world and pose an immense socioeconomic burden despite the considerable accumulative burden of these diseases only a small number of multinational registries for a few selected autoimmune diseases have been devised.

Numerous autoimmune inflammatory diseases have been associated with various forms of vasculopathy and increase vascular disease risk such as accelerated atherogenesis and thromboembolic events as digital and acral gangrene secondary Raynaud syndrome arterial aneurysm and different cutaneous ulcer.

The etiopathogenesis os increased risk of peripheral vascular diseases and presentation in autoimmune diseases is not entirely clear but multiple contibutors have been explored especially in the context of systemic inflammation and disordered thrombogenesis.


Eligibility Criteria:
Inclusion Criteria:

* all ages
* Both sexes
* Recent or past history of vascular diseases or presentation in any proven autoimmune diseases according to the guidlines.

Exclusion Criteria:

* patients refuse the study
* patients do not have established diagnosis of vascular diseases .
* patients not completely approved to have autoimmune diseases.
Genetic Architecture of Neutrophil-Mediated Inflammatory Skin Diseases

This study is to identify rare, disease-causing mutations of several rare neutrophil dermatoses. To identify associations between NMID and variants in the genome next generation sequencing, mainly whole exome sequencing, will be used. In a second approach the expression level of already known inflammatory proteins in skin samples will be investigated.

The origin of rare severe inflammatory skin diseases in dermatology is insufficiently known. They have in common the presence and activation of phagocytes, affect the quality of life through pain and inflammation and disfiguration, and can even be fatal. This study is intended to build on the findings that several of these neutrophil-mediated inflammatory dermatoses (NMID) have a genetic background and to identify rare, disease-causing mutations of several rare neutrophil dermatoses. This non-clinical case-control study is a research project with biological material and health-related data. To identify associations between NMID and variants in the genome next generation sequencing, mainly whole exome sequencing, will be used. In a second approach the expression level of already known inflammatory proteins in skin samples will be investigated. The data are obtained and verified using standardized methods as e.g. Nanostring, RNA sequencing and qRT-polymerase chain reaction (PCR), proteomics assays and immunohistochemistry as well as flow cytometry and imaging mass cytometry, ELISA, and Western Blot.

Eligibility Criteria:
Inclusion Criteria:

* written consent of the participating person
* diagnosis of a disease in the NMID form group or proband of the control group

Exclusion Criteria for patients:

* Missing informed consent if samples collected after 2014
* no diagnosis of NMID

Exclusion Criteria for healthy controls:

* Missing informed consent
A Study to Assess the Safety, Pharmacokinetics and Anti Tumor Activity of UCB6114 Administered Intravenously to Participants With Advanced Solid Tumors

The purpose of the study is to characterize the safety and pharmacokinetic (PK) profile of UCB6114 administered as monotherapy or in combination with selected standard of care (SOC) regimens.


Eligibility Criteria:
Inclusion Criteria:

* Participant must be at least 18 years of age inclusive, at the time of signing the informed consent
* Participant has advanced disease (ie, locally advanced or metastatic)
* Participant has measurable or non-measurable disease as defined by the relevant Response Evaluation Criteria in Solid Tumors (RECIST)
* Participant has an Eastern Cooperative Oncology Group (ECOG) performance status of ≤1

Part A specific:

- Participant has a histologically and/or cytologically confirmed diagnosis of one of the following advanced solid tumor types: colorectal adenocarcinoma, esophageal carcinoma, head and neck squamous cell carcinoma, lung adenocarcinoma, lung squamous cell carcinoma, pancreatic adenocarcinoma, prostate adenocarcinoma, stomach adenocarcinoma, bladder urothelial carcinoma, or breast invasive carcinoma

Part B and C specific:

- Participant has a histologically and/or cytologically confirmed diagnosis of one of the following advanced solid tumor types: colorectal adenocarcinoma, gastric adenocarcinoma, or adenocarcinoma of the gastroesophageal junction

Part A1 specific:

- Participant has histologically and/or cytologically confirmed diagnosis of one of the following advanced solid tumor types: colorectal adenocarcinoma, gastric adenocarcinoma, adenocarcinoma of the gastroesophageal junction, or pancreatic cancer

Exclusion Criteria:

* Participant has a known hypersensitivity to any components of the study medications or comparable drugs
* Active and clinically significant bacterial, fungal, or viral infection, known infections with hepatitis B, hepatitis C, known human immunodeficiency virus, or acquired immunodeficiency syndrome related illness
* Symptomatic central nervous system (CNS) malignancy or metastases. Screening of asymptomatic participants without history of CNS metastases is not required. Participants with asymptomatic CNS lesions should have completed standard therapy for their CNS lesions prior to study enrolment
* Current hematologic malignancies
* Prior organ or allogeneic stem-cell transplantation
* QT interval corrected (QTc) \>450 msec
* Participant has impaired renal function
* Alanine transaminase or AST are ≥2xULN (if liver metastases are present: ≥5xULN)
* Participant has moderate or severe cardiovascular disease
* Current or chronic history of liver disease or known hepatic or biliary abnormalities other than liver metastases
Association of Biliary Tract Disorders in Chronic Kidney Disease Patients and Its Related Risk Factors

Our aim in this cross-sectional study is to determine the frequency and aspects of gallbladder dysfunction and the related risk factors in pre-ESRD and hemodialysis patients.

Biliary tract disorders including cholelithiasis, cholecystitis, and other diseases of the biliary tract, are one of the most prevalent medical issues in the digestive system, posing a myriad of challenges for health workers and patients. Gallbladder dysfunction is the most frequent cause of symptomatic and complicated biliary tract disorders. Although gallbladder dysfunction is a common condition in Middle East countries, data on the incidence of end-stage renal disease (ESRD) are limited. The occurrence of gallbladder dysfunction in patients fed with low-protein diets suggests that gallbladder stones formation is affected by dietary protein content. Also the lithogenic composition changes of bile, increased nucleation tendency, and impaired motility of gallbladder are important factors in ESRD patients. It has been reported that chronic kidney disease (CKD) patients on regular hemodialysis (HD) have increased bile cholesterol levels and an increased bile saturation index. In addition, the gallbladder is innervated by the autonomic nervous system, which malfunctions in uremia, and it has been shown that gallbladder stasis might cause increased stone formation. In some studies, the prevalence of gallbladder dysfunction has been shown to increase in patients undergoing hemodialysis (HD) treatment for ESRD. So, we focused in this study to try to find association of gallbladder dysfunction in pre-dialysis ESRD and HD patient in comparison to normal renal function individuals.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are diagnosed as CKD with eGFR according to Cockcroft-Gault Equation, whatever they are on regular hemodialysis or pre-dialysis without history of previous gallbladder dysfunction with normal renal function individuals.

Exclusion Criteria:

* Patients who are younger than 18 years.
* Patients who are diabetic.
* Patients who have body mass index (BMI) more than 30.
* Patients who have family history of gallbladder disorder.
Dexmedetomidine Dosage for Postoperative Delirium and Cognitive Function in Elderly TKA Patients

This study aims to evaluate the efficacy of dexmedetomidine in reducing the incidence of postoperative delirium and cognitive dysfunction in elderly patients undergoing total knee arthroplasty (TKA). The study will compare the outcomes of patients receiving dexmedetomidine to those receiving a standard anesthetic or sedative, focusing on factors such as patient characteristics, surgical duration, and postoperative care. The research will explore the potential neuroprotective effects of dexmedetomidine and its ability to mitigate the risks associated with anesthesia and surgery in vulnerable elderly populations.


Eligibility Criteria:
Inclusion Criteria:

* Patients with Severe chronic knee osteoarthritis inducing limitation of movement and required knee replacements;
* Patients of American Society of Anesthesiologists Classification grades II-III;
* Patients free of exclusion criteria.

Exclusion Criteria:

* Patients of American Society of Anesthesiologists Classification grade \>III;
* Patients show a high risk for getting Post Operative Delirium or have severe cognitive dysfunction;
* Patients had a history of uncompensated cardiac, renal, or hepatic diseases;
* Patients had uncontrolled diabetes mellitus or hypertension;
* Patients had other causes for limited movement;
* Patients had autoimmune disease, coagulopathy, severe anemia with a hemoglobin concentration of \<7 g%;
* Patients had local bone disorders that may prevent prosthesis stability;
* Patients had allergies or contraindications to the study drugs.
The Evaluation of Safety, Tolerability and Pharmacokinetics of Stroke Targeting Drug in Healthy Volunteers

The purpose of this study in to evaluate safety, tolerability, pharmacokinetics of JPI-289 in healthy male subjects.

tPA treatment should be used within 3 hours after stroke onset for treating efficacy, but JPI-289 treatment(PARP-1 inhibitor) showed treating efficacy more than 10 hours after stroke onset. PARP-1 inhibitor add-on therapy of tPA will be very useful to prevent social, economic loss from physical, and mental disable by stroke.

This clinical trial progresses to explore safety, tolerability, pharmacokinetic/pharmacodynamic properties of JPI-289 by single dose escalation(7cohort). Investigational product medication of each level within 4 weeks evaluate safety and tolerability of patient through Data Safety Monitoring Board(DSMB) which is composed of more than 3 experts except principal investigator until the last visit. In each level 6 patients for investigational product and 2 patients for placebo will be allocated respectively in double blind manner.

Eligibility Criteria:
Inclusion Criteria:

* 19\~55 years healthy male
* BMI measurement 20kg/m²\~27kg/m²
* 90 ≤ SBP\<140(mmHg) 60 ≤ DBP\<100(mmHg) 45 ≤ Pulse rate\<100(bpm)
* Signed the informed consent from to participate voluntarily and to comply with the trial requirements
* For a follow-up visit and during the study period, blood samples and availability

Exclusion Criteria:

* History of clinically significant hepatic, gastrointestinal, pulmonary, musculoskeletal, endocrine, psychiatric, hematooncologic, cardiovascular (Specially asthma, obstructive pulmonary disease, peptic ulcer)
* History of skin disease of graft affecting absorption of the drug
* History of drug abuse
* Positive urine drug screening
* Administrated investigational product in a previous clinical trial within 60 days of the screening test
* Donated blood within 60 days prior to screening test
Development and Validation of a Short Tool to Assess the Awareness of Pregnancy-induced Hypertension

Background: Pregnancy-induced hypertension (PIH) is responsible for most perinatal and fetal mortality. Few programs are patient-centered during pregnancy, increasing the risks of misinformation and misconceptions among pregnant women and, as a result, malpractices. Objective: This study aims to develop and validate a form to assess the knowledge and attitudes of pregnant women about PIH.

Many observational studies explored the awareness of pregnant women of PIH, but no structured tool is available to assess such awareness. During the past two years, education campaigns were postponed and primary care was prioritized. To allow better-informed decisions and targeted actions, this pilot study aims to develop and validate a short form to assess the knowledge and attitudes of pregnant women about pregnancy-induced hypertension. The long-term objective of this study is to provide a practical tool for pregnant women.

Eligibility Criteria:
Inclusion Criteria:

* Participants were asked to participate in the study with no criteria based on race, ethnicity, or gestational age.

Exclusion Criteria:

* Those with a history of hypertension or pre-eclampsia were excluded.
Effects of the Variation in the Time of Systemic Administration of Metronidazole and Amoxicillin Associated to the Non-surgical Therapy of Chronic Periodontitis.

• Background: Peridontitis is a group of diseases with complex bacterial etiology that affects a large proportion of the Chilean and worldwide population. Its treatment, based on an anti-infective mechanical therapy including scaling and root planning procedures, has been highly effective in numerous short and long term clinical trials. The use of adjunctive systemic antibiotics has shown significant improvements in the initial therapy results of specific periodontal disease types or patient profiles.

The synergic combination of Metronidazole plus amoxicillin has been widely and successfully used for the treatment of aggressive and severe chronic periodontitis, demonstrating additional benefits in clinical and microbiological parameters over scaling and root planning alone. However, and despite its proven efficacy, there is a lack of evidence that evaluates the impact of antimicrobials intake at different times of the mechanical treatment, emphasizing the necessity of a study that compares, simultaneously, the variation of the adjunctive antibiotic effects when they are administered in different moments through the periodontal therapy course.


Eligibility Criteria:
Inclusion Criteria:

* a) age of 35 years old or more, b) at least 3 molars in the mouth, c) at least one site in three of the four quadrants with clinical attachment loss ≥ 3mm; d) at least 4 sites in different teeth with probing depth and clinical attachment level ≥ 6mm and bleeding on probing and at least 14 tooth present in the mouth

Exclusion Criteria:

* a) previous professional root planning; b) systemic/topic antibiotic or antiinflammatory treatment, at least 6 months prior to the initiation of the study; c) immunosuppression or need for antibiotic coverage for routine dental therapy; d) systemic condition that could affect the progression of periodontal disease (diabetes); e) pregnancy or lactation; e) allergy or intolerance to metronidazole or amoxicillin; f) smokers