cyrilzakka/clinical-trials huggingface dataset:
Study to Assess Pegloticase (KRYSTEXXA®) in Patients on Hemodialysis

This is a Phase 1 single dose study conducted to evaluate the PK and PD of pegloticase administered to hemodialysis patients.

A single dose of pegloticase will be administered intravenously to male or female hemodialysis patients (N = 12) starting 3 hour prior to dialysis.

The study consists of a Screening Period, a Treatment Period, and Follow up Period.

End stage renal disease (ESRD) patients that require hemodialysis typically undergo hemodialysis treatment 3 times per week. As such, medications can be dialyzed off, reducing their clinical effectiveness; this study is being conducted to understand how dialysis affects the pharmacokinetics (PK) and pharmacodynamics (PD) of pegloticase.

Eligibility Criteria:
Inclusion Criteria:

1. 18 and 75 years of age, inclusive
2. Agrees to employ best possible methods to abstain from becoming pregnant or impregnating another.
3. Stage V chronic kidney patients with minimal or no residual renal function receiving hemodialysis and stable on hemodialysis (3x week)
4. BMI = 18.5 kg/m2 to \< 45 kg/m2

Exclusion Criteria:

1. Any surgical or medical condition that may interfere with drug absorption, distribution, metabolism, or excretion, or any other condition that may place the subject at risk

   1. Glucose-6-phosphate dehydrogenase (G6PD) deficiency
   2. Uncontrolled congestive heart failure
   3. Refractory chronic gout
2. History of drug and/or alcohol abuse within 6 months prior to screening
3. History of or current clinically significant mental disorder or an antagonistic personality that compromises the validity of the informed consent
4. Donation of blood or plasma within 30 days prior to dosing
5. History of or current hepatitis, or carriers of hepatitis B surface antigen (HbsAg) and/or hepatitis C antibodies (anti-HC).
6. Use of an investigational drug or product, within 30 days
7. History of clinically significant drug allergies or sensitivities
8. Females with a positive pregnancy test or who are breast feeding at Screening or plan to breast feed within 30 days of dosing
9. A baseline QTc interval ≥ 490 milliseconds for males and ≥ 510 milliseconds for females
10. Is unable to refrain from alcohol
11. Has taken any prescription or over the counter medication within 7 days prior to treatment day that, in the opinion of the Investigator, could be expected to confound the PK or metabolism of the study drug
12. Has taken the following herbal agents or nutraceuticals within 7 days prior to Screening: chapparal, comfrey, germander, gin bu huan, kava, pennyroyal, skullcap, St. John's Wort, or valerian
13. Has poorly controlled malignant hypertension (systolic blood pressure \[SBP\] \> 200 mm Hg and/or diastolic blood pressure \[DBP\] \> 120 mm Hg,
14. Concurrent use of urate-lowering drugs
Salivary Markers in Patients With Xerostomia

The purpose of this study was to investigate the salivary levels of inflammatory and their association with oral health in xerostomía patient

Primary Outcome Measures:

* salivary Proinflammatory and anti-inflammatory cytokines
* questionnaire is provided to the patient for xerostomia characterization

Secondary Outcome Measures:

* Probing pocket depth
* Probing pocket depth and clinical attachment level
* Gingival index
* Plaque index
* Bleeding on probing

Eligibility Criteria:
Inclusion Criteria:

• The patient must have clinical symptoms of xerostomia (dry mouth)

Exclusion Criteria:

* Head and neck radiotherapy
* Administration anti-inflammatory drugs or antibiotic therapies within the previous 6 months
* Patients who are unable or unwilling to cooperate
* Patient suffering from cancer
ATHENAS - Retrospective Study of Compliance in Chronic Hepatitis C With Pegylated Interferon Alfa-2b/Ribavirin in Brazil (P05632)

This is a Phase 4, retrospective and observational, multicenter, national (Brazil), open, noncomparative, and nonrandomized study, which does not have visits. This study will be conducted in accordance to Good Clinical Practices. The procedure will be the review of medical records of patients who have already completed 12 weeks of treatment of chronic hepatitis C with peginterferon alfa-2b and ribavirin. This review will take place after the subjects have signed the informed consent form authorizing collection of these data. The collection of data for virological response after Week 12 will be collected prospectively through the review of medical records after the subjects have completed their entire treatment and follow-up period.

This is a Phase 4, retrospective and observational, multicenter, national (Brazil), open, noncomparative, and nonrandomized study, which does not have visits. This study will be conducted in accordance to Good Clinical Practices. The procedure will be the review of medical records of patients who have already completed 12 weeks of treatment of chronic hepatitis C with peginterferon alfa-2b and ribavirin. This review will take place after the subjects have signed the informed consent form authorizing collection of these data. The physician will be filling out the case report form with the information contained in the medical record. Any dose reduction and/or doses not taken during this period will be reported through the case report form. The collection of data for virological response after Week 12 (such as virological response at the end of treatment and sustained virological response after follow-up period) will be collected prospectively through the review of medical records after the subjects have completed their entire treatment and follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* Must have confirmed his/her willingness in participating in this study, after having been informed of all aspects that are pertinent to his/her decision to participate, by signing and dating the informed consent form (ICF) approved by the Institutional Review Board / Independent Ethics Committee on Research (IRB/IEC).
* Adult patients who are 18 years old or above.
* Must have diagnosis of chronic hepatitis C confirmed through positive qualitative or quantitative PCR (polymerase chain reaction) performed prior to initiation of the patient's treatment. This result shall be documented in the patient's records.
* Must have completed 12 weeks of treatment with peginterferon alfa-2b and ribavirin.
* Patients who started treatment for chronic hepatitis C from the year 2008 or later.

Exclusion Criteria:

* Does not confirm his/her willing in participating in this study or refuses to sign the informed consent form.
* Did not start the treatment with peginterferon alfa-2b and ribavirin.
* Patients who have less than 12 weeks of treatment with peginterferon alfa-2b and ribavirin.
Assessment of Asthma Mimics Among Newly Diagnosed Bronchial Asthma Patients

The aim of the study was to identify the percentage of patients in whom the diagnosis of current asthma was confirmed or ruled out after clinical, spirometric assessment and utilizing all the possible investigations with a six month follow up period for both groups.

The diagnosis of bronchial asthma relies on the existence of characteristic respiratory symptoms which are reversible and variable (diurnal and seasonal) with variable airflow limitation. Unfortunately, bronchial asthma may mimic different pulmonary and non-pulmonary diseases regarding their similar clinical presentations so accurate assessment is required to exclude other possible diagnosis before confirming the diagnosis of bronchial asthma.

There are various phenotypes of asthma as; atopic, non-atopic, and late-onset asthma, which may not be easily diagnosed in the community. Also, asthma may show intermittent versus a relapsing /remitting course, so it is difficult to be diagnosed by a single physician visit. Different studies have found that patients with bronchial asthma were treated empirically without full assessment either to ensure or exclude the asthma diagnosis.

Some symptoms as chest wheezes and breathlessness may be presented commonly in bronchial asthma and other mimic diseases as; chronic obstructive pulmonary disease, bronchiectasis, congestive heart failure, vocal cord disorders, hypersensitivity pneumonitis, endobronchial tumours, pulmonary embolism, aspiration syndromes, tracheal compression by a mediastinal mass and tracheomalacia. So, different physicians should put in mind those asthma mimics to be differentiated from asthmatic patients specially whose asthma symptoms are poorly controlled by anti- asthmatic medications.

Eligibility Criteria:
Inclusion Criteria:

* 1) Patients aged ≥ 18 years who had newly clinically diagnosed bronchial asthma (the diagnosis was achieved in the previous one year, to allow us to get the previous diagnostic reports) whether the diagnosis of asthma was initially made based on clinical assessment alone or both clinical and spirometric assessment. 2) Both sexes were included.

Exclusion Criteria:

* 1) Patients who were using long-term oral steroids that may mask the diagnosis; 2) unable to do spirometry or contra-indicated. 3) pregnancy. 4) Definite diagnosis of other chest diseases.
Myofascial Release With and Without Support Belt for Sacroiliac Joint Pain in Pregnant Females.

This study will be a randomized controlled trial that will include myofascial release interventions with and without a support belt. 34 Patients will be randomly divided into 2 groups. Assessment will be done by using Numeric Pain Rating Scale, Quebec scale for functional disability, and Pelvic girdle pain questionnaire (PGQ).

Sacroiliac joint dysfunction is a particularly common source of pain during pregnancy and is often an undiagnosed cause of low back pain. In this study, the effects of myofascial release with and without a support belt for sacroiliac joint pain and activity in pregnant females will be analyzed.

Group A of 17 patients will get a myofascial release technique for up to 600 seconds and total treatment sessions will be 12 in 4 weeks with a support belt a support belt should not be worn for longer than two to three hours at a time and it will be used 4 times a week. Group B of 17 patients will also get a myofascial release technique for up to 600 seconds and total treatment sessions will be 12 in 4 weeks but without a support belt. Data will be collected and analyzed at baseline and at 4 weeks follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Age 20-40 years.
* 2nd and 3rd trimesters of pregnancy.
* The diagnosis of SIJ pain based on tenderness localized to the posterior inferior iliac spine bilaterally with provocative maneuvers of the SIJ in posterior pelvic pain provocation/thigh thrust test, compression test, Gaenslen's test and Patrick's Faber test eliciting considerable pain.
* Positive results from at least three of those provocative tests signified the presence of SIJ pain.

Exclusion Criteria:

* History of rheumatic disease.
* Lumbar spine disc herniation or back injury.
* Previous lumbar spine surgery.
* High risk pregnancy.
* Any bony or soft tissue systemic disease.
* Malignancy.
Mild Hypothermia and Supplemental Magnesium Sulfate Infusion in Severe Traumatic Brain Injury (TBI) Subjects

The investigators hypothesize that hypothermia (body cooling) and additional magnesium sulfate will improve the outcome of severe Traumatic Brain Injury (TBI) patients.

This is a study to compare the outcomes of patients with severe traumatic brain injury who have been allocated to one of the following three groups:

Group 1 - Conventional therapy following traumatic brain injury Group 2 - Subjects will have their core body temperature lowered to 34C Group 3 - Subjects will have their core body temperature lowered to 34C and will receive a supplemental intravenous infusion of magnesium sulfate.


Eligibility Criteria:
Inclusion Criteria:

1. Adult males or females ≥ 18 years of age
2. Subjects with Traumatic Brain Injury and a post-resuscitation Glasgow Coma Score (GCS) ≤ 8
3. In-hospital and screened within 7 hours of injury.
4. Able to obtain legally effective written consent from authorized representative
5. Patients who are intubated and on mechanical ventilation
6. Admitted to ICU

Exclusion Criteria:

1. Bladder or rectal core temperature below 32C (89.6F) upon admission
2. Clinical brain death
3. Patients with open abdomens.
4. Multiple orthopedic injuries (\> 2 long bone fractures)
5. Persistent hypotension (systolic blood pressure \< 90mmHg)
6. Persistent hypoxia (O2 Saturation \< 94%)
7. Persistent metabolic acidosis (Lactic acid \> 5 mmol/L, arterial pH \< 7.25)
8. Positive serum pregnancy test
9. Cardiac arrhythmia with deleterious hemodynamic effects; heart block or myocardial damage (as shown on ECG)
10. History of abnormal renal function
11. Significant Co-morbidity (i.e. CAD;COPD; severe coagulopathy)
12. Pediatric patients (\< 18 years old)
The Study of Biomarker in Early Diagnosis of GDM by Metabolomics

Gestational Diabetes Mellitus (GDM) refers to abnormal glucose metabolism during pregnancy, in which elevated blood glucose is first found during pregnancy and meets the criteria for diabetes. In recent years, with the increase of obese women of childbearing age, the incidence of GDM has been rising, the current global average incidence is about 14%, and the incidence in China has increased from 2% in 1999 to 5%-8% at present. If one-step diagnosis is used, the rate will be between 13%-17%, which will greatly increase the social burden. Gestational diabetes mellitus (GDM) significantly increases the risk of diseases for pregnant women and infants, such as abortion and premature delivery, concurrent hypertension, concurrent infection, metabolic disorders, postpartum diabetes, macrosomia, fetal malformation, neonatal hypoglycemia, neonatal respiratory distress syndrome, and so on. It is one of the important public health problems threatening human health. Therefore, the accurate diagnosis of GDM is of great clinical significance for the timely formulation of intervention and treatment measures, reducing the risk of maternal and infant diseases and improving the level of public health.

The study will follow a prospective cohort design and be conducted in Peking Union Medical College Hospital. All basic information was collected in the first trimester, and all subjects underwent OGTT (75g glucose) at 24-28 weeks of gestation. GDM will be diagnosed using the criteria of the IADPSG. At four time points during pregnancy (6-13 weeks, 24-28 weeks, 36-weeks before delivery, and 6 weeks after delivery), blood samples of 5ml were collected from each subject at each time point without increasing the number of blood samples. In the GDM group, blood samples were collected at the same time during routine visit 6 weeks after delivery. The relevant broad metabolomics and targeted vitamin profiles were also detected. Meanwhile, blood glucose values at the corresponding time points were collected. Using these variables, we will combine the metabolomics information to screen a predictive marker for GDM in Chinese reproductive age population.

Eligibility Criteria:
Inclusion Criteria:

* First trimester (6-13 weeks)；Pregnant women with a singleton pregnancy；Pregnant women who are registered at the hospital and have regular antenatal check-ups；Pregnant women who volunteered for the study were required to sign an informed consent form

Exclusion Criteria:

* Pregnant women with known type 1 or type 2 diabetes mellitus；Pregnant women with hyperlipidemia and hyperbilirubinemia；Pregnant women with hepatic and renal insufficiency
Dragon Ambient eXperience (DAX) Copilot Evaluation

AI solutions like, Dragon Ambient eXperience (DAX) Copilot (Nuance/Microsoft), hold the potential to significantly enhance provider and patient interactions and alleviate pain points that contribute to burn out. Atrium Health was the first healthcare system in the world to pilot Nuance's DAX Copilot intelligence (AI) enabled scribe software, which synthesizes a draft clinic note by "listening" to the conversation between a provider and patient. After 180 days of use by primary care clinicians and advanced practice providers (APPs), along with a control group, the investigators assess provider satisfaction, patient experience, and provider efficiency through qualitative and quantitative methods.

In this non-randomized stepped-wedge trial, clinicians (including physicians and advanced practice providers \[APP\]) specializing in family medicine, internal medicine, and general pediatrics were recruited from outpatient clinics located in North Carolina and Georgia. The intervention group was divided into 5 waves between June and August 2023 based on clinic locations. Prior to the activation of accounts, clinicians underwent a one-hour training session on DAX Copilot. Meanwhile, a comparison group comprising clinicians not utilizing DAX was recruited in five waves from locations and specialties similar to those of the intervention group. Two types of primary outcomes, electronic health record (EHR) metrics and financial metrics, were assessed after 180 days of intervention. EHR metrics include time in EHR (EHR8), work time outside of work (WOW8), time in documentation (Note8), completed appointment rate, same day closure rate, and note length. Financial metrics include gross revenue per visit and work relative value units (wRVU) per visit. Secondary outcome include provider satisfaction survey, provider interview, and patient satisfaction survey.

Eligibility Criteria:
Inclusion Criteria:

* clinicians specializing in family medicine, internal medicine, and general pediatrics (including physicians and advanced practice providers \[APPs\])
* (intervention group) showed interests in participating in Dragon Ambient eXperience (DAX) Copilot
* (control group) clinicians who opted out from Dragon Ambient eXperience (DAX) Copilot in vendor's baseline survey
* (control group) clinicians who worked in the same clinic/region as the intervention group

Exclusion Criteria:

* preceptors
* inactive DAX participants (i.e., had DAX license but never activate it)
* have the same first use and last use DAX date
* missing demographics
Effect of Normatec Pump for Relief of Leg Edema in Patients With Right Heart Failure

Mobilization of fluid from the legs with the Normatec pump in patients with right heart failure, may empty the "reservoir" in the legs from excessive fluid, enabling fluid overload to collect there rather than in the liver or in other third spaces. Thus, we hypothesize that patients will lose weight, feel better, look better, be less prone to infections in their legs and to congestion of the liver.

The protocol will be divided into 2 parts:

1. The initial pumping phase will be an in-hospital study, short term study. Patients will be randomly assigned to conventional/conservative treatment or to pump therapy. Within 24 hours of admission patients assigned to pump therapy will be recruited for the study and will begin therapy according to the protocol outlined in the table below. These patients will not be given diuretics unless required to because of shortness of breath with suspected left heart failure. Individualized programs regarding pumping frequency and pump parameters will be set for each patient and will be adjusted during the first few days and maintained throughout the study unless there is a reason to modify them.

   Data on both the conventional/conservative and the pump arms of the study will be collected at similar intervals. The duration of the in-hospital period will not be extended because of the study and is expected to be 3-7 days.
2. An intermediate-term study in which the patients from the phase 1 study will be ambulatory. During this phase of the study the effect of continuous maintenance and optimization will be monitored. Patients will come to the hospital for their pumping session at which time the protocol tests will be performed. Patients that were assigned to the conventional/conservative arm in phase 1 will be examined as per protocol at 1, 2 and 3 weeks after admission but BNP levels will be repeated only after the 3rd week.
3. At 3 and 6 months after admission, the "long term" phase of the study, a systematic investigation regarding repeat hospitalizations and their causes will be carried out by telephone interview and by a review of admission data from hospital records.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized patients
* Adults
* Right heart failure secondary to pulmonary hypertension (cor pulmonale)
* Pronounced leg edema

Exclusion Criteria:

* Patients in sepsis
* Hemodynamically unstable
* Renal failure (creatinine \>2 mg%)
* Deep vein thrombosis
* Pregnancy
* Psychiatric/noncompliant patients
* Patients who will not sign the informed consent form
A Study of Leukocytapheresis (LCAP) in Patients With Ulcerative Colitis (UC)

This is a prospective, randomized, double-blind, sham treatment controlled multicenter study.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed to have UC in the active stage based on clinical symptoms and findings from endoscopy
* Patients with pancolitis type or left-sided colitis type lesion of 15 cm or longer observed endoscopically
* Patients with Mayo score between 5 and 10
* Patients with Mayo sub-score (findings from flexible sigmoidoscopy) of 2 or 3
* Patients not having received any corticosteroids (referred to as steroids) (p.o., i.v., enema, suppository) within the past 6 weeks

Exclusion Criteria:

* Patients with a difficulty in peripheral vascular access
* Patients having received ACE inhibitor (at least 10 times of its half-life time for interval needed before initiating the treatment)
* Patients with toxic megacolon
* Patients with a malignant disease or its experience
* Patients with a severe cardiovascular disease (grade III or IV by the Classification of heart functions of the New York Heart Association (NYHA))
* Patients with a liver or kidney disease (AST(GOT) or ALT(GPT) or total bilirubin or creatinine level which is 2 or more times higher than the upper limit of normal (abbreviated as ULN, hereinafter)
* Patients suspected to have or having HBV or HCV or HIV or pathogenic bacteria
* Patients on anticoagulant therapy or with abnormality in the blood coagulation system (PT or PTT levels which are 1.5 or more times higher than ULN
* Pregnant women or patients with possible pregnancy
* Breast feeding women
* Patients weighing 40 kg or less
* Patients with hemoglobin level of less than 6.5 mmol/L (10.5 g/dL)
* Patients with platelet count of less than 150 x 103/mm3, 150 x 109/L (15 x 104/mm3)
* Patients with white blood cell count of less than 3.5 x 109/L (3,500/mm3)
* Patients with hypotension (with systolic blood pressure of 80 mmHg or less)