cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the A1CNow+ Test Kit

The purpose of this study was to assure that consumers can successfully use the new version of A1CNow+ along with revised instructional materials.

The purpose of this study was to assure that consumers could successfully use the new version of A1CNow+ Test Kit along with revised instructional materials. The primary objective was to establish accuracy and secondary objectives were to establish precision, comprehension of instructional materials, and user feedback about the overall testing experience.

Eligibility Criteria:
Inclusion Criteria:

1. Adults (age 18 and older) approximately 80% being ≤55 years old
2. Persons with:

   * known diabetes (type 1 or type 2) and pre-diabetes - approximately 85% of subject population per site
   * no known diagnosis of diabetes - approximately 15% of subject population per site
3. Individuals who are interested in performing a test using the kit at home
4. Individuals willing to complete all study procedures (including venous draw and allowing site staff to perform finger punctures)
5. Individuals who are able to speak, read, and understand English
6. Individuals able to read out loud the first 5 lines of the A1C Test Kit instructional materials to demonstrate ability to read the print (may use glasses, if needed)

Exclusion Criteria:

1. Individuals taking prescription anticoagulants (such as Warfarin or heparin) or have clotting problems that may prolong bleeding. (Taking Plavix or aspirin daily is not excluded)
2. Individuals with known Rheumatoid Arthritis or other condition causing significant impairment of manual dexterity
3. Individuals with a known hemoglobin variant such as HbS or HbC
4. Individuals with any known disorder of the blood or blood-forming organs (such as recovery from blood loss, hemolytic anemia, or iron deficiency anemia)
5. Individuals who have received a blood transfusion within the 4 months prior to the study.
6. Persons with known infection with a bloodborne pathogen (e.g. HIV, hepatitis)
7. Individuals working for a competitive medical device company
8. Individuals who have participated in previous studies on the A1CNow+ product
9. Persons missing a digit or partial digits on the hand
10. Individuals with the following impairments which, in the opinion of the investigator, would seriously compromise the integrity of the study:

    * Significant visual impairment
    * Significant hearing impairment
    * Cognitive disorder
    * Any other condition as per investigator's discretion
Ketamine for Acute Suicidal Ideation in the Emergency Department: Randomized Controlled Trial

This study will enroll patients presenting to the emergency department with acute suicidal ideation meeting inclusion and exclusion criteria. Patients will be randomized to one of three arms: ketamine (intervention) or diphenhydramine (control) or placebo (control). Serial measurements will be made in the ED and at follow-up intervals.


Eligibility Criteria:
Inclusion Criteria:

* Patients age 18 to less than 75 who present to the SAMMC ED with either overt or incidental suicidal ideations with a SADPERSONS score 5 or greater that the treating provider feels warrant formal evaluation.

Exclusion Criteria:

* -Poor vital sign stability hypoxia: O2 \< 95%, hypotension: SBP\< 90 hypertension: SBP\>180 Heart rate: \< 50 or \>120 Respiratory Rate: \<10 or \>30
* Altered mental status or intoxication
* Patient is unwilling to participate or provide informed consent
* Any allergy to ketamine or diphenhydramine
* Patient is female of child-bearing age and unwilling to provide urine or blood for HCG analysis
* Pregnancy or breast feeding
* Presence of chronic oxygen-dependent pulmonary disease, liver cirrhosis, or renal disease requiring dialysis
* Presence of ischemic heart disease, heart failure, or a history of unstable dysrhythmias
* Presence of intracranial mass or vascular lesion.
* Presence of a history of psychosis or hallucinations (as assessed by electronic chart review)
* Weight greater than 115 kg or less than 45kg
* History of increased intracranial pressure/hypertensive hydrocephalus
* Non-English speaking patients
* Patient is acutely psychotic
* Provider feels that patient currently or likely will require chemical and/or physical restraints
* History of prolonged QT-interval
Incidence of Complications Associated With Anesthesia in Obesity Parturient Undergoing Cesarean Delivery

The incidence of obesity parturient has been increasing worldwide. There was a report revealing one third of pregnant women in United state considered obesity.

Obesity is associated with increased in maternal and neonatal complications. Also, there was an increasing in the rate of cesarean delivery. Anesthetic management of the obese parturient is differ from non-obese parturients. There were higher risk of difficult intubation, failed intubation, pulmonary aspiration and difficult regional anesthesia such as spinal anesthesia or epidural catheter placement comparing with non-obese parturient.

The aim of the study is to report complication associated with anesthesia in obese patients undergoing cesarean delivery in Single University hospital, Bangkok, THAILAND.

The incidence of obesity parturient has been increasing worldwide. There was a report revealing one third of pregnant women in United state considered obesity.

Obesity is associated with increased in maternal and neonatal complications. Also, there was an increasing in the rate of cesarean delivery. Anesthetic management of the obese parturient is differ from non-obese parturients. There were higher risk of difficult intubation and difficult regional anesthesia such as spinal anesthesia or epidural catheter placement comparing with non-obese parturient.

WHO categorised obesity into 3 classification; grade 1: BMI 30-34.9 kg/m2, grade 2: BMI 35-39.9 kg/m2, grade 3: BMI \> 40 kg/m2. This study emphasised in grade 3 obese pregnant women (BMI\>40 kg/m2) undergoing cesarean delivery that were at risk of increasing in anesthetic complications such as airway complications as well as complications derived from regional anesthesia eg. high spinal block, failed spinal block etc.

Therefore, the primary objective of the study is to report complication associated with anesthesia in obese patients undergoing cesarean delivery in Single University hospital, Bangkok, THAILAND. The secondary objectives rate of postpartum haemorrhage, rate of hysterectomy and neonatal outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women BMI\>,= 40 kg/m2 underwent cesarean delivery

Exclusion Criteria:

* Patients with gestational age \<,= 24 weeks
* Patients with death fetus in Utero
* Multiple gestation
* Patients with intrapelvic cavity pathology eg. myoma uteri
* Patients with abnormal placentation
* Patients with polyhydramnios
Safety Observation of the Japanese Encephalitis Vaccine Given With a Primary Immunization

This is a single-arm, non-randomized, open-label post-marketing safety observation study. The purpose of this study is to investigate the safety of JEV-I given with primary immunization in a large amount of healthy children aged 8 months and older.

Healthy children aged 8 months and older who choose to receive the study vaccine for primary immunization at their own expense in Jiangsu Province will be invited to participate in this study. No study vaccine will be supplied or administered as part of this study, participants will be monitored following vaccine administration in clinical settings.

The primary immunization program with JEV-I requires 2 intramuscular doses administered 7-10 days apart. All participants will be observed for the incidence of any adverse events (AEs) within 30 minutes and from 30 minutes to 7 days after each vaccination, including local and systemic reactions. Additionally, all participants will be observed for unsolicited AEs within 30 days after after each vaccination.

Eligibility Criteria:
Inclusion Criteria:

* Healthy children who have received the inactivated Japanese encephalitis vaccine.
* Legal guardian of the participants voluntarily participates in the clinical trial and signs an informed consent form.
* Legal guardian of the subject has the ability to understand the procedures of the study and accept all scheduled visits.

Exclusion Criteria:

-
Collection of Specimens for Study of Inflammatory Bowel Disease

This study will collect tissue specimens to be used for research on inflammatory bowel disease. The tissues will be used to explore why people get inflammatory bowel disease and to try to develop new treatments based on the study results. Tissue from patients with IBD will be compared with that from patients who do not have the disease

Patients who undergo bowel surgery for inflammatory bowel disease (IBD) or another bowel disorder may be eligible for this study. Patients with IBD must be at least 4 years of age; those with another disorder must be 18 years of age or older.

Participants undergo bowel surgery for their disease. Some of the intestinal tissue removed during the surgery that is not needed for medical care, such as for pathological examination, is provided to researchers for study under this protocol. In addition, patients with IBD provide a blood sample for genetic testing. Several genetic variations, or mutations, may increase the risk of developing IBD; blood samples from patients may help identify these variations.

Our ongoing natural history studies of the etiology and immune abnormalities of the group of diseases known collectively as the inflammatory bowel diseases require access to clinical samples of intestinal tissue as well as blood samples for genotyping. This protocol provides a mechanism for procurement of intestinal samples obtained at the time of medically-indicated surgical procedures from patients with IBD or some other non-IBD diagnosis (to act as a control group). In addition it allows for the procurement of blood for DNA preparation as more IBD susceptibility genes are discovered and we further our work on association of genetic polymorphisms/mutations with the phenotype and immune abnormalities observed in our IBD patients.

Eligibility Criteria:
* INCLUSION CRITERIA FOR SUBJECTS WITH INFLAMMATORY BOWEL DISEASE:

  1. Presence of idiopathic inflammatory bowel disease as established by prior endoscopic, histologic, and/or radiographic findings.
  2. Ability to give consent or have legally authorized person give consent and agree to sample storage.

EXCLUSION CRITERIA FOR SUBJECTS WITH INFLAMMATORY BOWEL DISEASE:

1. Less than 4 years old.

INCLUSION CRITERIA FOR SUBJECTS WITHOUT INFLAMMATORY BOWEL DISEASE:

1. Absence of idiopathic inflammatory bowel disease as established by tests that exclude these diagnoses.
2. Ability to give consent and agree to sample storage.

EXCLUSION CRITERIA FOR SUBJECTS WITHOUT INFLAMMATORY BOWEL DISEASE:

1. Less than 18 years of age.
A Study of The Effect of RoActemra/Actemra (Tocilizumab) in Combination With Methotrexate on Articular Damage in The Hand in Patients With Moderate to Severe Rheumatoid Arthritis Who Have an Inadequate Response to Non-Biological DMARDs

This open-label, single arm study will evaluate the effect of RoActemra/Actemra in combination with methotrexate on articular damage in the hand (synovitis/osteitis and erosions) in patients with moderate to severe rheumatoid arthritis who have an inadequate response to non-biological disease-modifying ante-rheumatic drugs (DMARDs). Patients will receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks for 24 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/= 18 years of age
* Diagnosis of rheumatoid arthritis according to ACR/EULAR classification (2010) of \>/= 6 months duration
* Active moderate to severe rheumatoid arthritis (DAS \>/= 3.2)
* Swollen joint count (SJC) \>/= 6, tender joint count \>/= 8
* Synovitis in the dominant hand
* Inadequate response to stable dose of a non-biological DMARD for at least 3 months
* Oral corticosteroids must have been on stable dose for at least 25 out of 28 days before first dose of study drug
* Patient on outpatient treatment

Exclusion Criteria:

* Major surgery (including joint surgery) in the 8 weeks prior to screening, or planned major surgery within 6 months of randomization
* Rheumatic autoimmune disease other than rheumatoid arthritis
* American College of Rheumatology (ACR) functional class IV
* History of or current inflammatory joint disease other than rheumatoid arthritis
* Previous inadequate response to a biologic DMARD; prior biologic therapy for no longer than 1 month is allowed if discontinued for reasons of tolerability at least 6 months prior to study recruitment
* Intra-articular or parenteral corticosteroids within 6 weeks prior to study start
* Inadequate hematologic, renal or liver function
* Positive for hepatitis B, hepatitis C or HIV infection
* Pregnant or lactating women
* History of severe allergic reactions or anaphylaxis to human, humanized or mural monoclonal antibodies
* Current infections or history of recurrent infections
* History of or currently active primary or acquired immunodeficiency
* Active tuberculosis requiring treatment in the previous 3 years
* Body weight \> 150 kg
Tofatib Treatment for IgG4-related Disease

Compared with cyclophosphamide, the efficacy and safety of tofacitinib in the treatment of active IgG4-related diseases were evaluated.

This study is a prospective, single center, non randomized, controlled, open label clinical observation study to evaluate the efficacy and safety of tropitib versus cyclophosphamide in inducing remission in IgG4-RD patients.

2) Investigators observe the diagnosis and treatment of IgG4-RD patients, and only provide patients with clinically appropriate diagnosis and treatment proposals.

It does not interfere with the choice of treatment plan for patients with the study drug of tropib or cyclophosphamide. If the patient chooses the hormone combined with tofatib or the hormone combined with cyclophosphamide as the main treatment drug, and at the same time meets the inclusion and exclusion criteria of this study, the patient can be included in this clinical observation study and become a subject. The experimental group was treated with glucocorticoid combined with tofatib, and the control group was treated with glucocorticoid combined with cyclophosphamide. It is planned that 20 people in each group will be treated for 6 months. After the study, the number of subjects in each group shall be at least 20 according to the actual situation. In the final statistical analysis, ensure that the sample size of the two groups participating in the statistical analysis is controlled at about 1:1.

3) The primary end point of this study was to compare the remission rate of the two groups after treatment; The secondary end point was to compare the response rate, recurrence rate and adverse event rate of the two groups after treatment.

Eligibility Criteria:
Inclusion Criteria:

* It meets the 2019 ACR/EULAR classification diagnostic criteria for IgG4 related diseases, and is an active IgG4-RD, defined as an IgG4-RD RI score ≥ 3 points when screening

Exclusion Criteria:

* 1. IgG4 related diseases endangering organ function or life;

  2. Only Mikulicz disease, no other internal organs involved;

  3. People with history of thrombotic disease or high risk of thrombosis;

  4. Have a history of malignant tumor;

  5. Active infection;

  6. Pregnant or lactating women;
Immunogenicity and Tolerability of Broad Spectrum Human Papillomavirus (HPV) Vaccine in Adult and Young Adult Women (V503-004)

This study will assess the safety and immunogenicity of GARDASIL®9 (V503) in 16- to 45-year-old women. The primary hypothesis of the study states that anti-HPV 16, 18, 31, 33, 45, 52, and 58 geometric mean titers (GMTs) at 4 weeks postdose 3 are non-inferior in adult women as compared with GMTs in young adult women.


Eligibility Criteria:
Inclusion Criteria:

* good physical health

Exclusion Criteria:

* history of an abnormal Pap (Papanicolaou) test or abnormal cervical biopsy results
* history of HPV-related condition
* history of known prior vaccination with an HPV vaccine
* pregnant
* user of recreational or illicit drugs
* history of severe allergic reaction, including known allergy to any vaccine component
* immunocompromised
* history of certain medications or is currently taking or has taken certain medications (details will be discussed at the time of consent)
* has thrombocytopenia or other coagulation disorder
* concurrently enrolled in a clinical study of investigational agent
STOP-Bang Score and Factors Predicting Difficult Intubation for Prediction of Difficult Mask Ventilation in Obese Patients

The goal of this prospective observational study is to test combination of STOP-Bang score and factors predicting difficult intubation can improve accuracy of prediction difficult mask ventilation in obese patients that undergoing to elective surgery under general anesthesia.

The main question\[s\] it aims to answer are:

* Can combination of STOP-Bang score and factors predicting difficult intubation improve accuracy of prediction difficult mask ventilation in obese patients?
* Study about complication after endotracheal tube insertion in obese patients that undergoing to elective surgery under general anesthesia.

Participants who undergoing to elective surgery under general anesthesia will

* Routine preoperative evaluation and ask about STOP bang questions, evaluate neck circumference, Mallampati grade,Thyromental distance (That routine physical examination for anesthetic care pre-operation)
* In operation room, patients will be inducted anesthesia by anesthesiologist (step routine for general anesthesia),observe difficult mask ventilation grading before intubate endotracheal tube and complication after endotracheal tube insertion.

If there is a comparison group:

Researchers will compare obese patients with/without high STOP bang score \>=3 point plus factor predicting difficult intubation (Mallampati grade 3-4, Neck circumference \> 42 cm, Thyromental distance \< 6 cm)to prediction difficult mask ventilation


Eligibility Criteria:
Inclusion Criteria:

* BMI ≥ 25 kg/m2
* Age \> 18 years old
* undergoing elective surgery under general anesthesia with endotracheal intubation

Exclusion Criteria:

* History of difficult mask and intubation
* Maxillofacial or upper airway malformation
* History of C-spine disease such as trauma, degeneration
* Pregnancy
* Rapid sequence induction technique
Feasibility Trial of ValenTx Endo Bypass System

The purpose of the study is to provide initial clinical data to support the feasibility of use of the ValenTx Endo Bypass system in enhancing weight loss and co-morbidity resolution in morbidly obese patients.

This is a single center open label feasibility study to evaluate the safety, efficacy and performance of the ValenTx Endo Bypass system.

Eligibility Criteria:
Inclusion Criteria:

* Male or female between 18 and 55 years of age
* \>=35 kg/m2 and \<= 50 kg/m2, with or without comorbid conditions(s).
* Documented failure with non-surgical weight loss methods
* Willing to comply with study procedures and visit schedule
* Willing and able to provide Informed Consent

Exclusion Criteria:

* Pregnancy or intention of becoming pregnant within the study duration.
* Endoscopic lesions such as important hiatal hernia, gastric or duodenal ulcer, atresias or stenosis, polyps of the stomach.
* Subject with potential upper gastrointestinal bleeding such as esophageal or gastric varices, Mallory-Weis syndrome or congenital or acquired intestinal telangiectasia.
* Past history of esophageal or gastric/GI surgery, obstruction, adhesive peritonitis, or large hiatal hernia (\> 3 cm).
* IBS, unexplained intermittent vomiting, severe abdominal pain or chronic constipation within 60 days of study day 1
* Unexplained anaemia, Pancreatitis, Portal hypertension, Esophagitis or Barrett's esophagus, known gallstones or anomalies of the GI tract
* Any bodily infections within 30 days of study day 1.
* Prolonged steroid use
* Hep C or HIV positive
* Known allergies to any of the device materials
* Use of weight loss medication or an investigational drug or device within 2 months prior to enrolment and throughout the study period.
* Recent or ongoing cancer, history of severe renal, hepatic, cardiovascular or pulmonary disease or transplants
* Inability to tolerate anti-inflammatory medications
* Evidence of psychiatric problems or dietary habits that would contraindicate study treatment;
* Active drug or alcohol addiction within 12 months of enrolment and throughout the study duration.
* Prior history of inflammatory diseases of the GI tract, (e.g., esophagitis, varices, gastric or duodenal ulceration, or Crohn's disease; congenital or acquired GI anomalies, e.g., bowel strictures)
* Ongoing treatment with anticoagulants, steroids, aspirin, NSAIDs, or other gastric irritants within 1 month prior to enrollment and throughout the study period.
* Participation in previous (within 60 days of study day 1) or ongoing clinical trial or current or past usage (within 60 days of study day 1) of investigation drug or device.
Anatomical Variation of Cerebral Venous Sinus in Healthy Individuals

The anatomical characteristics of veins and venous sinus result in great differences between cerebral venous system diseases and cerebral artery diseases in etiology, pathophysiology and clinical features.Therefore, understanding the anatomy and variation of normal venous sinuses is essential to identify the intracranial venous lesions.

The classification of venous sinus and its variation based on the autopsy of patients can not fully reflect the real anatomy and variation of venous sinus in human, and the targeted research on healthy people is still unknown. The main purpose of this research is to use multimodal magnetic resonance technology to study the variation of venous sinus in Chinese healthy population, to preliminarily improve the anatomical classification of venous sinus in Chinese , to verify the the correlation between venous sinus variation and various non-genetic factors at the same time, as well as establishing reliable quantitative evaluation indicators.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 - 35 years old.
2. Confirmed no intracranial diseases, congenital abnormalities such as intracranial hematoma, tumor, vascular malformation, hydrocephalus, etc.
3. Voluntarily signed informed consent.

Exclusion Criteria:

1. Any clinical history, including hypertension, diabetes, coronary heart disease, hematologic and rheumatic immune system diseases,cervical spondylosis, anxiety, depression, insomnia, etc.
2. Internal jugular venous outflow disturbance : MRV from extracranial to aortic arch demonstrates variation or stenosis of the internal jugular vein, vertebral plexus, brachiocephalic vein, and superior vena cava.
3. Any history of craniocerebral trauma or surgery that affected the existence and running of veins.Unhealthy habits such as smoking, heavy drinking, etc.
4. Women who are pregnant or in preparation for pregnancy or lactation.
5. Other conditions that the researchers considered might affect the trial and inappropriate for inclusion.