cyrilzakka/clinical-trials huggingface dataset:
Safety Observation of Enterovirus 71 Inactivated Vaccine (Vero Cell) Combined Immunization in Shanghai

This study is an open clinical trial of the EV71 vaccine (Vero cell), Inactivated manufactured by Sinovac Research \& Development Co.,Ltd.The purpose of this study is to evaluate the safety of EV71 vaccine (Vero cell), Inactivated co-administration with other vaccines

This study is an open clinical trial in children aged 6-71 months old. The purpose of this study is to evaluate the safety of EV71 vaccine (Vero cell), inactivated co-administration with other vaccines.The EV71 vaccine was manufactured by Sinovac Biotech Co.A total of 12500 subjects aged 6-71 months old were enrolled.All subjects received one dose of EV71 vaccine and one of other vaccines(such as MMR vaccine,encephalitis vaccine,mumps vaccine,inactivated poliomyelitis vaccine,influenza vaccine and so on ) at the same time.

Eligibility Criteria:
Inclusion Criteria:

* 6 months ≤ Age of enrollment ≤71 months;
* Voluntary and self-funded completion of EV71 vaccine combined immunization with one of the other type I or II vaccines;
* The subject and/or guardian can understand and voluntarily sign the informed consent form;
* Subjects and their legal guardians are able to attend follow-up visits and follow all study procedures (such as cooperating in completing safety observation notes).

Exclusion Criteria:

-
Quantification of Dilutional Anemia in the Initial Phase of Sepsis Management: Preliminary Retrospective Study

This is a single-center retrospective study conducted at Mercy hospital, aiming to investigate the correlation between changes in hemoglobin (Hb) levels and the volume of vascular refill administered during the first 48 hours.

Vascular refill is central to the initial management of hypotension in sepsis, and is often started even before the patient is admitted to intensive care. Over the past 20 years, we have moved from ultraliberal fluid resuscitation to restrictive resuscitation. Indeed, in the early 2000s, the implementation of an early and aggressive hemodynamic optimization strategy, including liberal vascular filling, improved the survival of critically ill patients, and ushered in the era of the Surviving Sepsis Campaign. However, studies have shown increased morbidity and mortality associated with a positive fluid balance. Restrictive approaches to fluid resuscitation and/or deressuscitation were then tested. While these approaches failed to demonstrate any benefit in terms of mortality, they did have the merit of demonstrating their feasibility and good tolerability, albeit with a little-explored pathophysiology. Little is known about the problem of dilutional anemia in the acute phase of septic shock.

Eligibility Criteria:
Inclusion Criteria:

* Patients with septic shock, admitted to Mercy hospital between November 1, 2022 and July 31, 2023, with Noradrenaline administration for at least 6 hours and at least 2 hemoglobin measurements during the first 48 hours of resuscitation.

Exclusion Criteria:

* patients with acute bleeding or blood transfusion before or during the first 48 hours of resuscitation.
Check List to Improve Patient Self-care and Product Defect Report in Continuous Ambulatory Peritoneal Dialysis

Peritoneal Dialysis (PD) has been the main method of treatment for Thai End-Stage Renal Disease (ESRD) patients under the "PD First" policy of the Universal Coverage (UC) scheme. The increased demand has resulted in not only supply chain logistical problems, but also product quality concerns. Peritonitis, the main complication and checklist cause of failure in Continuous Ambulatory Peritoneal Dialysis (CAPD) patients, could be caused by a product defect. This cluster randomized trial will be conducted in 22 randomly selected PD centers in Thailand to assess if a checklist intervention could reduce peritonitis rate and increase the number of checklist product defect report.

Peritoneal Dialysis (PD) has been the main method of treatment for Thai End-Stage Renal Disease (ESRD) patients under the "PD First" policy of the Universal Coverage (UC) scheme. The increased demand has resulted in not only supply chain logistical problems, but also product quality concerns. Peritonitis, the main complication and main cause of failure in CAPD patients, could be caused by a product defect.

PD Product Check List was developed based on the 28 routine steps of standard orientation manual for new Thai PD patients. Of these, step 2 (weighting the PD solution bag), step 3 (checking expiration date, volume, glucose concentration, clarity, and color, step 27 (weighting the PD solution bag), and step 28 (recording time, volume, and any abnormality encountered) are relevant to product defect report.

This cluster randomized trial will be conducted in 22 PD centers (anticipated 20-25 prevalent and 10-15 incidence PD cases per center) to answer the primary research question: is the checklist intervention effective in reducing peritonitis rate? The secondary research questions will also be considered: does the checklist help increase the number of product defect report?

Peritonitis incidence rate is the primary outcome, defined based on the International Society for Peritoneal Dialysis (ISPD) 2010 recommendation. Product defect incidence is the secondary outcome, measured by a number of incidence of product defect reported by the patients. Given no standard definition, a PD solution product will be considered defective if it is expired on the day of use, incorrect glucose concentration, abnormal clarity or color, physical abnormality of the box and/or the bag, or loose connector.

Because of the nature of the intervention, blinding is not possible. Cluster randomization will be performed to allocate 11 PD centers to the study group and the other 11 PD centers to control group. While all subjects will receive standard PD care, subjects in the study group will also receive the checklist plus a 30-minute orientation of how to use the checklist.

Eligibility Criteria:
Inclusion Criteria:

* ESRD patients who start peritoneal dialysis not longer than one month and participate in PDOPPS study

Exclusion Criteria:

* ESRD patients who receive only hemodialysis
* ESRD patients who receive emergency peritoneal dialysis
* Illiterate ESRD patients or their caregivers
A 5 Treatment Period Pharmacokinetic Study Evaluating Dose Proportionality and Food Effects of Diazoxide Choline Controlled-Release Tablet (DCCR)

Open label, parallel-group, single site, 5 treatment-period study with 4 dose levels of DCCR, 1 of which is administered both with and without food.

Open label, parallel-group, single site, 5 treatment-period study with 4 dose levels of DCCR, 1 of which is administered both with and without food, with a 10 Day washout period between treatments. There will be 8 treatment sequences with 4 subjects randomized to each.

Eligibility Criteria:
Inclusion Criteria:

* Ability to follow verbal and written instructions
* Informed consent form signed by the subject
* Completed screening within 7 days prior to dosing
* BMI between 18.5 and 35 kg/m2
* Generally healthy
* fasting glucose less than or equal to 100 mg/dL
* HbA1c less than or equal to 6%

Exclusion Criteria:

* Pregnancy or breast feeding
* absence of contraception
* administration of investigational drug within 1 month prior to screening
* anticipated requirement for prohibited medication (systemic corticosteroids or anti-diabetic medications)
* allergic reaction to or significant intolerance of diazoxide, thiazides or sulfonamides
* known type 1 or type 2 diabetes mellitus
* congestive heart failure
* gastric bypass surgery
* history of drug or alcohol abuse
Comparison of Vigorous Versus Low Intensity Cool Room Treadmill Training in People with Multiple Sclerosis

New research in animal models of MS suggests that greater training intensity is required to restore lost functions. We have developed and tested vigorous intensity cool room treadmill training that people with MS who have fatigue and heat-sensitivity can tolerate. This study will focus on the appropriate dosage of training.

Our previous research showed that vigorous aerobic training in a room cooled to 16°C can improve walking and measures of brain plasticity among people with MS related walking disability, especially in those who had fatigue and heat sensitivity. As a next step, we will compare our novel vigorous intensity cool room treadmill training to low intensity cool room treadmill walking and determine whether intensity is important in order to improve brain repair and restore walking among people with MS. Our first objective is to compare the effects of 12 weeks of vigorous versus low intensity training on walking. Our second objective is to determine whether treadmill training alters indicators of brain repair. We hypothesize that the cool room vigorous training will result in greater increases in walking and less fatigue, which will be sustained at follow-up. We also hypothesize that improvements will align with less brain inhibition (shortened CSP measured using Transcranial Magnetic Stimulation) and greater upregulation of the neurotrophin IGF-1.

Eligibility Criteria:
Inclusion Criteria:

* people with a confirmed diagnosis of relapsing-remitting or progressive MS
* older than 18 and less than 70 years of age
* able to walk at least 10 meters with use of walking aids (Expanded Disability Status Scale (EDSS) \<7.0)
* must be stable without relapse for at least 90 days

Exclusion Criteria:

* currently attending physical rehabilitation
* functional community ambulators (gait speed\>120 cm/s)
* a relapse of MS
Tongue Depressor-related Ischemia-Reperfusion Injury in Tongue

This study aimed to detect tongue edema associated with the pressure exerted by a rigid direct laryngoscope by measuring the tongue area using USG in patients undergoing suspension laryngoscopy (SL) procedures.

Suspension laryngoscopy (SL) is a surgical procedure for both diagnostic and therapeutic purposes. In this procedure, a rigid direct laryngoscope is inserted orally, and the tongue and the base of the tongue are compressed.The tongue is an ideal organ for evaluation with ultrasonography. This study aimed to detect the occurrence of tongue edema through ultrasonography examination due to the rigid direct laryngoscope in SL procedures.

Eligibility Criteria:
Study group

Inclusion Criteria:

* Patients aged 20 years or older
* Patients who undergo suspension laryngoscope procedure

Exclusion Criteria:

* refusal to participate
* age of \<20 years
* history of syndromal craniofacial abnormalities
* occurrence of tongue masses
* history of craniofacial surgery
* history of burns, trauma or radiotherapy involving the head and neck region
* neurologic disorders and patients with obstructive sleep apnea syndrome (OSAS)
* active inflammation in the head and neck region
* cervical rigidity limiting neck flexion and head extension

Control group

Inclusion Criteria:

Patients aged 20 years or older Patients who did not need suspension laryngoscopy and any head and neck procedures
Immediate Load in Dental Implants Using Conventional Drilling and Piezoelectric Osteotomy on Aesthetic Zone.

Compare the survival rate of the implants placed using the ultrasonic technique and placed using conventional drilling, with an immediate load on the aesthetic zone.

Main goals.

Compare the survival rate of the implants placed using the ultrasonic technique and placed using conventional drilling, with an immediate load on the aesthetic zone.

Specific goals.

* Evaluate the marginal peri-implant bone loss after the healing period through radiographs, from the day of surgery, to a month, to 3 and 6 months after and a year after the implants insertion.
* Evaluate the primary stability of each individual implant the day of their insertion to verify their load on the moment of surgery and also compare the values of each preparation techniques of implant bone preparation.
* Evaluate the secondary stability of each individual implant and compare the values of each preparation techniques.
* Evaluate the peri-implant clinic parameters within 3 and 6 months and a year after the insertion of the implants through these variables: probing depth and bleeding of probing.

Eligibility Criteria:
Inclusion Criteria:

* Absence of teeth on the aesthetic zone, whether its an incisor, canine or premolar.
* 3 months after the dental extraction without alveolar scar tissue remains.
* Bone availability of at least 5mm of width and 13mm of length.
* At least 2 to 3 mm of soft tissue for the establishment of an adequate peri-implant biological width.
* Oclusal pattern that ensures prosthetic success.
* Implants need to have at least a 35 N and 70 ISQ index to be loaded.
* Index of plaque \< 20% and/or inactive periodontal disease.

Exclusion Criteria:

* Acute myocardial infarction in the last 2 months.
* Uncontrolled coagulation disorders
* Uncontrolled diabetes (HbA1c\> 7.5%).
* Radiotherapy on head/neck in the last 24 months.
* Immunocompromised patient.
* History of medication related to osteonecrosis of the jaws.
* Psychiatric disorders, alcohol, drugs and large smokers (\>10 cigarrillos).
* Plaque index \> 20%.
* Need for simultaneous or previous peri-implant guided bone regeneration procedures.
Study Comparing Bifeprunox to Risperidone in Treatment of Outpatients With Schizophrenia With Weight as Primary Endpoint

The purpose of this study is to determine the effect of bifeprunox or risperidone on the body weight of patients with schizophrenia.


Eligibility Criteria:
Inclusion criteria:

* Current treatment of at least 3 months with risperidone.
* Primary diagnosis of schizophrenia.
* Total Positive and Negative Symptoms Scale (PANSS) score \< or = 70 at screening and baseline.

Exclusion criteria:

* Psychiatric diagnosis other than schizophrenia as assessed by the modified Mini International Neuropsychiatric Interview (MINI) and considered by the investigator to be the primary psychiatric diagnosis.
* History or presence of clinically significant cardiovascular, endocrine, hepatic, renal or other medical disease that might be detrimental to the subject or confound the study.
* History of any suicide attempt within 3 years of day 1 or significant immediate risk of violence or suicidality.
Reliability of a Endurance and a Strength Test for Shoulder Rotation

Introduction: Verification of the progression of individuals submitted to training programs is performed by diagnostic tests with a focus on strength and muscular endurance. Among the tools used are the elastic bands, the halter, the pulley, the digital dynamometer and, additionally, the isokinetic dynamometer, considered the gold standard of evaluation. However, there is a lack of standardization in assessments and scarcity in the exploration of some tools and some muscle groups. Observation is often restricted to a particular study design and makes comparisons difficult even with the use of the same tool. Thus, to include different clinical possibilities in the same scenario can enrich the discussion about the topic. Objective: To develop and analyze the validity and reliability of a maximal muscle strength test for the external rotator muscles of the shoulder in five tools; To develop and analyze the validity and reliability of a localized resistance test for the external rotator muscles of shoulder in three different percentages of maximum strength (60%, 70%, 80%) in four tools; To characterize by means of the physiological response the localized muscular endurance test with the load that presents with the highest reliability values in each tool. Method: The study will consist of a sample of 50 participants of both genders, and will be performed in 3 steps: (1) Validation and reliability of the maximum muscle strength test; (2) Reliability of the muscular endurance test (MET); (3) Physiological characterization of the muscular endurance test (MET). Stage 1 will be held in 3 sessions (familiarization, test and retest) in which participants will perform 5 tests of maximum strength with different tools (elastic bands, pulley, halter, digital dynamometer and isokinetic dynamometer). Stage 2, consisting of 6 sessions, will be tested and retest of a muscular endurance test with different loads (70%, 80% and 90% of maximum force) with the same devices of step 1, except the digital dynamometer. In Step 3 participants will be selected with the lowest variations between the test and retest in the variable "time" to perform the physiological characterization of the test with the different tools. In order to observe the physiological response, we will analyze the lactic anaerobic (lactate concentration), allelic anaerobic (post-exercise oxygen uptake (EPOC) and aerobic (VO 2 values) parameters). The statistical package SPSS Statistics 22.0 will be used to conduct the analyzes. Key words: Fatigue, Physical resistance, Muscle strength, Lactate.


Eligibility Criteria:
Inclusion Criteria: should report the absence of:

* anemia,
* diabetes,
* cardiovascular disease,
* and upper limb and spinal muscular injuries in the last six months

Exclusion Criteria:

* absence at any study session and
* episode of muscle-tendon or osteoarticular injury in the upper limbs during the study.
Feasibility and Diagnostic Accuracy of Myocardial SPECT Using Early Imaging Protocol

Encouraged by the recent data published ,the investigators think that a waiting time of 10 minutes is feasible while preserving diagnostic accuracy and would like to assess the feasibility and diagnostic efficacy of W10 compared with W30 imaging in a pilot study. By combining W10 imaging with half-time acquisition, the time of the technetium-99m myocardial perfusion imaging procedure could be shortened by at least 50%, lasting only 40 minutes for W10 (10-minute waiting) imaging compared with 90 minutes for W30 imaging (30-minute waiting).

The investigators hypothesize that (1) W10 MPI is clinically feasible and tolerable by the patients, that (2) W10 MPI provides high image quality and that (3) W10 MPI provides diagnostic accuracy comparable to W30 MPI.


Eligibility Criteria:
Inclusion Criteria:

* Men and women ≥18 and ≤ 89 years of age of any race /ethnicity
* Patient has undergone or is being scheduled for a clinically indicated CardiacCath with or without angioplasty
* Patient may have suffered myocardial infarction more than 3 days before T99m-MPI
* Patient may have undergone percutaneous transluminal coronary angioplasty (PTCA) or coronary stent placement more than 3 days prior to T99m-Myocardial Perfusion Imaging (MPI)
* Interval between T99m-MPI and CardiacCath is within 30 days
* Females cannot be pregnant or lactating
* Women of no child-bearing potential (post-menopausal defined as amenorrhea ≥ 12 consecutive months, or because they have undergone successful surgical sterilization and deny current history of pregnancy and nursing). These subjects do not require serum pregnancy test on the day of the study
* Women of childbearing potential will require a negative serum pregnancy test, performed on the day of the study
* Provide signed Informed Consent prior to undergoing the study procedures

Exclusion Criteria:

* Patients less than 18 and ≥89 years of age
* Patient has been involved in any other investigative, radioactive research procedure within 7 days and during the study participation period
* History of 2nd or 3rd degree Atrio-ventricular-block, or sinus node dysfunction unless the patients have a functioning artificial pacemaker
* Current ventricular tachycardia, atrial fibrillation, atrial tachycardia, or atrial flutter
* Current unstable angina or cardiovascular instability
* Current history of exacerbated Chronic Obstructive Pulmonary Disease (COPD) or asthma
* Known hypersensitivity or contraindication to regadenoson or aminophylline
* Use of caffeinated substance, dipyridamole-containing medication, aminophylline, or xanthines containing medication (e.g. theophylline) within the 12 hours prior to Lexiscan administration
PanTheR Registry Trial

This study is a multicenter, observational, post-marketing, registry study designed to track the safety and performance of the RenovoCath® device and assess survival outcomes in patients diagnosed with solid tumors who are treated with localized intra-arterial (IA) delivery of therapeutic agents to solid tumors using the RenovoCath® catheter.

This study will enroll patients diagnosed with solid tumors who are willing to participate in the registry and meet the study enrollment criteria. Participants will be treated with therapeutic agents using RenovoCath® for the approved intended use according to the current country-specific Instructions for Use (IFU). Participants will be followed for survival outcome. Patients may chose to consent to participation in the registry before, during, or after treatment with the RenovoCath® device.

This observational post-marketing registry study is intended to track the safety and performance of the RenovoCath® device and assess patient survival / clinical outcomes of RenovoCath® in a real-world, clinical, observational setting when used for targeted delivery of therapeutic agents. Up to 1000 patients will be enrolled at up to an estimated 100 sites. Each patient participating in the registry study will have medical record retrievals including past data as of the time of their initial diagnosis through all localized IA administrations of therapeutic agent(s) using RenovoCath®, with continued record retrieval through the end of patient follow-up to record mortality rates. Patient data collection will include prior treatment history. Patients and/or their families will be contacted periodically after the treatment(s) to assess survival. It is anticipated that each participating patient's records will be retrieved approximately four times throughout the course of their treatment and follow-up, or retrospectively should patents decide to participate in the registry upon the completion of their treatment or during follow-up. This registry study is expected to continue for six years from study commencement.

Eligibility Criteria:
Eligibility Criteria:

1. Male and female patients who have been diagnosed with solid tumor cancers and are at least 18 years of age at the time of the first IA procedure
2. Patients willing to provide informed consent and HIPAA release for use of their relevant medical records