cyrilzakka/clinical-trials huggingface dataset:
Biktarvy in Treatment-Naïve Late Presenters With HIV-1 Infection

The efficacy and safety of Biktarvy in Treatment-Naïve Late Presenters with HIV-1 Infection

HIV epidemic is still severe in China, the estimated number if PLWH in HIV is around 1.25 million all of China with an increasing trend of new cases. Late presenters with low CD4 T cells and/or with hight viral load should be paid more attention for better treatment and care. As a new combined antiretroviral regimen of integrase inhibitor, B/F/TAF was recently approved in US and European and also in China which needs more real world data in China. Non-inferiority or advantage of B/F/TAF comparing with the first line TDF/3TC/EFV for later presenters in China needs to be explored.

Eligibility Criteria:
Inclusion Criteria:

1.Ability to understand and sign a written informed consent form 2.18 years old or older 3.Confirmed HIV-antibody positive through Western Blot testing without any previous ART 4.CD4 \< 200/mm3, VL \>1000 copies/ml 5.Estimated glomerular filtration rate (GFR) ≥ 50 mL/min (calculated by CKD-EPI) 6.Clinical status relatively stable 7.Females of childbearing potential must agree to utilize highly effective contraception methods or be non-heterosexually from screening throughout the duration of study treatment and for 30 days following the last dose of study drug.

Exclusion Criteria:

1. A new AIDS-defining condition diagnosed within the 30 days prior to screening
2. Participants experiencing severe organ lesion.
3. Positive serum pregnancy test or planned to be pregnant.
4. Females who are breastfeeding
5. With carcinoma
6. Concomitant medication of immunosuppression or chemoradiotherapy
7. Participation in any other interventional clinical trial
8. Screening stage find: Hb \< 9g/dL, WBC \< 3000/ul. neutrophilic granulocyte\< 1500/ul, PLT\< 75000/ul. Scr \> 1.5 ULN,Hepatic transaminases (AST and ALT) and ALP \> 3 × ULN,total bilirubin ≤ 2 x ULN.
9. Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with dosing requirements
Influence of Central Sensitization on Efficacy of Patient-controlled Epidural Analgesia in Osteoarthritis Patients Undergoing Total Knee Replacement

Nociceptor inputs can trigger a prolonged but reversible increase in the excitability and synaptic efficacy of neurons in central nociceptive pathways, the phenomenon of central sensitization. The degenerative joint disease, osteoarthritis, with characteristic destruction of cartilage and alteration in bone is a very common cause of chronic pain. The degree of pain does not always correlate with the extent of joint damage or presence of active inflammation raising the possibility that there may be a central component to the pain. The central sensitization inventory (CSI) is a new self-report screening instrument to measure the degree of central sensitization, and to help identify patients with central sensitivity syndromes. The aim of this investigation is to evaluate the influence of preoperative central sensitization, which represented by CSI score, on postoperative pain score in osteoarthritis patients undergoing total knee replacement who receiving patient-controlled epidural analgesia.


Eligibility Criteria:
Inclusion Criteria:

* Aged 20 to 80 years osteoarthritis patients undergoing total knee replacement under spinal anesthesia, and who receiving postoperative epidural PCA

Exclusion Criteria:

* refusal
* coagulopathy
* neurologic deficit
* preoperative opioids medication
* recent analgesics change
Analysis of B Cells From Autoimmune Individuals

This observational study aims at finding out if individual with autoimmunity exhibit increased numbers of B cells that express two types (instead of one type) of antibodies, and if B cells of individuals genetically susceptible to autoimmunity display defects in the biological process of tolerance, which removes B cells that participate in autoimmunity.

Peripheral blood B cells of SLE patients are analyzed by flow cytometry to determine the frequency of B cells co-expressing immunoglobulin kappa an lambda light chains. This frequency is correlated to the disease activity.

Eligibility Criteria:
Inclusion Criteria:

* Adult Males and Females diagnosed with Lupus;
* Adult Females who are pregnant and diagnosed with:

  * lupus erythematosus
  * rheumatoid arthritis, or
  * type 1 diabetes.

Exclusion Criteria:

* Adult males or adult females treated with B-cell depletion therapies.
Eltroxin Administration to Patients With Extremely Low T4 Values in the Intensive Care Unit

Nonthyroidal illness (formerly called sick euthyroid syndrome) is a common condition in patients hospitalized in the intensive care unit, and it is caused by changes in the levels of thyroid hormones in the blood . These changes are correlated to the severity of the critical illness, morbidity and mortality. This condition is characterized by low serum T3 levels, high rT3 levels, normal or low T4 levels, and normal or low TSH levels. Previous studies have shown a relationship between NTIS (nonthyroidal illness) and poor therapeutic outcomes in patients admitted with sepsis, multi trauma, ARDS, acute respiratory failure, septic shock and mechanically ventilated patients in intensive care .

In general, the recommendation is not to routinely take blood tests to evaluate thyroid function in critical patients in the intensive care unit, unless they were previously known to have a thyroid disease or there is a clinical suspicion that such a disorder developed during hospitalization in the intensive care unit. Also, studies so far have not shown an advantage for eltroxin administration to intensive care patients with low T3 and/or T4 levels when the laboratory tests indicate NTIS. However, there is a specific group of patients, with NTIS and extremely low T4 levels (less than 50% of the lower limit of the normal range) who have a particularly high mortality rate in intensive care (over 85%) and in whom it has not been investigated whether the administration of eltroxin will improve the therapeutic outcomes ( , i.e. was such a low T4 level in them considered a marker for the severity of their general critical illness, or is it another disorder in itself, the treatment of which would benefit the patient) . We would like to examine whether the administration of eltroxin in this specific group of patients, which has not been studied so far, will be beneficial in improving the therapeutic outcomes


Eligibility Criteria:
Inclusion Criteria: All patients aged 18--99 who were admitted to the general intensive care unit from January 2016 to November 22, 2023 for any reason, and who during their hospitalization in the intensive care unit had lower than normal T4 levels measured. It is about 350 patients. Of these, we will specifically examine the group of patients for whom an extremely low level of T4 was measured (less than 50% of the lower limit of the norm).

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Exclusion Criteria: Patients who were known to have a chronic thyroid dysfunction prior to their hospitalization in the unit, patients who were regularly treated with eltroxin prior to their hospitalization

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Efficacy Comparison of Topical and Intravenous Tranexamic Acid to Reduce the Number of Blood Transfusions in TKA

The main objective is to evaluate the efficacy and safety of topical Tranexamic Acid (TA) to reduce the blood transfusion rate in total knee arthroplasty. The secondary endpoints are to estimate the visible blood loss at 24 hours after surgery, and invisible blood loss through serial counting of Hb/Htc. Methodology. TRANEX1 is a phase III, unicentric, controlled, randomized, double blind clinical trial that compare efficacy and safety of topical TA versus intravenous TA in a multimodal protocol, with no-inferiority criteria(n=79).

The groups will be compared by ITT and PP. The non-inferiority would be estimated by comparing the confidence interval using the traditional test, and Wilson test.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (greater than 18 years old)
* Patients scheduled for primary unilateral knee arthroplasty
* Patients for La Paz- Cantoblanco Hospital, Madrid, Spain

Exclusion Criteria:

* Patients that refuse to sign the Inform Consent
* Allergy to tranexamic acid
* Major comorbidities: Severe ischemic heart disease(class III and IV of New York Heart Association); sleep apnea syndrome; severe EPOC; renal dysfunction (plasma creatinine\>2mg/dL if mens and \>1.8mg/dL if woman); or hepatic disfunction.
* Coagulopathy (preoperative platelet count \<150,000/mm3, INR\>1.4, prolonged PPT(\>1.4 x normal)
* History of thromboembolic disease: CVA, DVT, PE
* Blood dyscrasias
* Retinopathy (disturbances of color vision)
* Jehovah's witnesses
* Pregnancy
* Breastfeeding
* Been participating or been participated a year ago in another clinical trial
The Impact of Neut During Potassium Chloride Replacement on Pain and Incidence of Phlebitis

The purpose of this study is to examine the impact of 4% sodium bicarbonate additive during peripheral intravenous potassium chloride replacement therapy for adult patients in a Medical/Surgical unit. Using a randomized controlled double blinded experimental study design, patients who are 21 years or older are alert, awake, and oriented at the time of enrollment and have been ordered peripheral intravenous potassium chloride replacement will be recruited from one Medical/Surgical during the first 24-48 hours of their admission.

The specific aim of the study is:

Aim 1: To compare patient outcomes (phlebitis, pain at peripheral IV insertion site, frequency of changing IV access, and time for administration) between the experimental (4% sodium bicarbonate additive during peripheral intravenous potassium chloride replacement therapy) and control (standard of practice of no 4% sodium bicarbonate additive during peripheral intravenous potassium chloride replacement therapy) groups.

Aim 2: To compare number and type of nursing interventions done during peripheral intravenous potassium chloride replacement therapy between the experimental (4% sodium bicarbonate additive during peripheral intravenous potassium chloride replacement therapy) and control (standard of practice of no 4% sodium bicarbonate additive during peripheral intravenous potassium chloride replacement therapy) groups.

Aim 3: To compare attrition rates and reasons between the experimental (4% sodium bicarbonate additive during peripheral intravenous potassium chloride replacement therapy) and control (standard of practice of no 4% sodium bicarbonate additive during peripheral intravenous potassium chloride replacement therapy) groups.

Eligibility Criteria:
Inclusion Criteria:

* admitted to the medical/surgical unit within the last 24 to 48 hours
* awake, alert, and oriented times three
* 21 years old and greater
* receiving first peripheral intravenous potassium chloride replacement therapy as ordered by physician or ARNP as part of care and regardless of research
* potassium level of 3.5 mmol/L or less.

Exclusion Criteria:

* patients who have been in the medical/surgical unit more than 48 hours.
* altered mental status defined as not being awake, alert, and oriented times three
* patients who already received intravenous potassium chloride replacement during the current admission and with the current IV access
* patients receiving intravenous potassium replacement therapy through a central line
* patients that are not ordered potassium replacement by physician or ARNP as part of their care while hospitalized.
What is the Effective Pulmonary Physiotherapy Method in Critically Care Patients?

Effects of the high frequent chest wall oscillation technique applied on the patients who were intubated in intensive care unit were investigated.

A total of 30 patients who were intubated and under the mechanical ventilator supplied, were included in the study. While the control group (n=15) received routine pulmonary rehabilitation technique, the study group (n=15) was administered high frequency chest wall oscillation for 72 hours as 4 times of 15-minute intervals, in addition to the pulmonary rehabilitation technique. Patients 'APACHE-II scores, dry sputum weight, Lung Collapse Index and blood gas values were measured at the hours 24th, 48th and 72nd, and endotracheal aspirate culture was studied at initial and 72nd. In addition, patient outcomes were evaluated at the end of the first week.


Eligibility Criteria:
Inclusion Criteria:

* aged over 18 years
* Patients with more than three days intubated, in critical care unit of Mengücekgazi Training and Research Hospital

Exclusion Criteria:

* Patients with rib fracture
* acute hemorrhage
* unstable intracranial pressure
* existence of chest drainage tube and those have history of spinal surgery,
* skin infection in the back and chest area and subcutaneous emphysema
Evaluate SAGE-547 in Female Participants With Severe Postpartum Depression

This is an open-label proof-of-concept study designed to evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of SAGE-547 Injection in adult female participants diagnosed with severe postpartum depression (PPD).


Eligibility Criteria:
Inclusion Criteria:

* Adult females, 18-45 years old who experienced a major depressive episode in the postpartum period beginning within the first 4 weeks following delivery
* Participant has ceased lactating, or if still lactating has already fully and permanently weaned their infant; if still actively breastfeeding, participant must agree to cease giving breast milk to their infant prior to study entry

Exclusion Criteria:

* Recent history or active clinically significant manifestations of metabolic, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, musculoskeletal, dermatological, urogenital, or eyes, ears, or nose and throat (EENT) disorders
* Active psychosis
* Medical history of seizures
Endoscopic Perfusion Utilizing ICG Fluorescence Technology

The main objective of the study is to evaluate the efficacy of indocyanine green (ICG) endoscopy to evaluate tissue perfusion during endoscopic neurosurgery. This includes patients with pituitary and intracranial tumors and treatment of vascular abnormalities such as aneurysms and compressive syndromes. ICG will be evaluated to determine the value of the additional visual information supplied during the treatment of these pathologies.

Over the past decade, a technique widely used by ophthalmologists to assess retinal blood flow, near-infrared ICG angiography, has been applied to neurosurgical patients undergoing a wide variety of cerebrovascular procedures. This technique offers the advantage of real-time visualization of cerebral blood flow through the operating microscope at the time the procedure is being performed. Indocyanine green is an ideal agent for imaging vessels as it is tightly bound to plasma albumin, has a short half-life, and maintains an acceptable safety profile. Furthermore, the excitation and emission profiles for ICG lie in the near-infrared wavelengths, which allow penetration and imaging of vessels below a few millimeters of tissue.

Patients with either an aneurysm, compressive syndromes or pituitary and intracranial tumor will be enrolled in the study. By taking advantage of the natural fluorescence of indocyanine green (ICG) within the red spectrum and applying a light filter to the endoscope eyepiece and camera it will show as to whether this technique provides adequate visual information to differentiate perfusion in tumor and surrounding structures and to evaluate normal vessels for aneurysm and compressive syndromes procedures.

Eligibility Criteria:
Inclusion Criteria:

* Patient population would include those patients with pituitary tumors, intracranial tumors, aneurysms, and normal tissue adjacent to tumors to clarify normal from abnormal. Also, patients with compressive syndromes to ensure patency of normal vessels. This would be all patients undergoing endoscopic surgery, both endonasal and open (retromastoid or transcranial).

Exclusion Criteria:

* Less than 18 years of age
* Iodine allergy
* Shellfish allergy
* Contrast allergy
* Previous anaphylactic reaction to ICG
* Pregnant
* Anyone with any evidence of renal or hepatic dysfunction
Acute Nutritional Ketosis in VLCAD Deficiency

To test if a ketone-ester based drink can boost muscle mitochondrial function in vivo in patients with VLCADD in order to establish a rational basis for therapeutic use in this disorder.

Exertional rhabdomyolysis is a common symptom in very long-chain acylCoA dehydrogenase deficient (VLCADD) patients. Failing muscle ATP homeostasis, due to impaired fatty acid oxidation, is the most likely cause. Therefore, supplementation with an alternative energy substrate to boost ATP homeostasis, such as an exogenous ketone ester (KE) drink, could be a therapeutic option. Previous results suggest that KE is preferentially oxidized in the tricyclic acid (TCA) cycle and improves physical endurance in athletes. Our primary objective is to test if KE boosts muscular ATP homeostasis in VLCADD patients to establish a rational basis for therapeutic use.

VLCADD patients will be included in a randomized, blinded, placebo controlled, 2-way cross-over trial. Prior to each test, patients receive a KE drink or an isocaloric carbohydrate equivalent, and completed a 35 min cycling test on an upright bicycle, followed by 10 minutes of supine cycling inside a MR scanner. The protocol will be repeated after at least one week with the opposite drink.

Eligibility Criteria:
Inclusion Criteria:

- Confirmed VLCADD by genetic profiling

Exclusion Criteria:

* contraindications for MRI studies (assessed by standardised questionnaire as previously used in METC 08-267/K; see UMCG section F METC documents)
* inability to perform bicycle exercise.
* recent episode of rhabdomyolysis, or treatment for acute renal failure in the past 2 months.
* intercurrent illness which may influence exercise tolerance (anaemia, musculoskeletal injury, or other undiagnosed illness under investigation).
* known coronary artery disease, positive history for angina, or changes on ECG suggestive of previous ischaemia without a negative stress test.
* insulin-dependent diabetes mellitus.
* loss of, or an inability to give informed consent.
* pregnancy or current breastfeeding, or females not taking the oral contraceptive pill (this is due to the variability in hormonal patterns and substrate levels with different parts of the menstrual cycle).
* any other cause which in the opinion of the investigators, may affect the volunteers ability to participate in the study.
Studying the Effects of 7 Days of Gonadotropin Releasing Hormone (GnRH) Treatment in Men With Hypogonadism

Men with Idiopathic Hypogonadotropic Hypogonadism (IHH) lack a hormone called gonadotropin releasing hormone (GnRH). This hormone is important for starting puberty, maintaining testosterone levels, and fertility. The purpose of this study is to research the effects of treating IHH men with GnRH for 7 days.

Despite variability in the triggers, timing, and pace of sexual maturity between species, all species utilize the final pathway of hypothalamic secretion of gonadotropin releasing hormone (GnRH) to initiate and maintain the reproductive axis. Thus, GnRH is required for reproductive competence in the human. The classic studies from the 1970s clearly demonstrate that pulsatile release of GnRH from the hypothalamus is a prerequisite for physiologic gonadotrope function. Absence, decreased frequency or decreased amplitude of pulsatile GnRH release results in the clinical syndrome of hypogonadotropic hypogonadism (HH). The phenotypic expression of GnRH deficiency in the human demonstrates considerable heterogeneity. Defining the physiology of GnRH is critical to understanding the clinical heterogeneity of isolated GnRH deficiency and its comparison to other conditions resulting in hypogonadotropic hypogonadism (HH). The overall goal of this protocol is to investigate the neuroendocrine control of reproduction and specifically the physiology and pathophysiology of GnRH secretion and action in the human male.

Subjects will be selected from a group of adult men (18-65 years)based on the demonstration of a low testosterone level (\<100 ng/dL) in association with low or inappropriately normal gonadotropin levels. All patients will undergo an initial assessment that includes an overnight 12-hour frequent blood sampling study to determine their degree of endogenous GnRH secretion. Following the overnight evaluation, subjects will have daily outpatient visits for 7 consecutive days when they will receive a GnRH bolus followed by 2hrs of blood sampling.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of idiopathic hypogonadotropic hypogonadism (IHH) or Kallmann syndrome (KS)Adult male 18-65 years of age
* Serum testosterone \<100 ng/dL

Exclusion Criteria:

* No specific exclusion criteria
The Role of 1.5-anhydro-D-glucitol as Clinical Biomarkers of Hypoglycemia in Patients With Diabetes

The purpose of this study is to evaluate the usefulness of plasma 1,5-anhydro-D-glucitol (1,5-AG) as a novel surrogate marker of hypoglycemia

We enrolled well controlled diabetes patients who had hypoglycemic event at least one time more. All patients assess the risk of severe hypoglycemia and hypoglycemic unawareness using hypoglycemic awareness questionnaires (HYPO score). The patients who are treated with insulin agent were inserted sensor of continuous glucose monitoring systems under the skin during three days. We were analysed the correlation between 1,5-anhydro-D-glucitol and HYPO score.

Eligibility Criteria:
Inclusion Criteria:

* patients attending outpatients of department of endocrinology and metabolism, seoul national university hospital .(HbA1C \<8%)
* The patients who treated with insulin or sulfonylureas at least 3month period
* In case fo sulfonylurea user, HbA1c was restricted under 8%
* The patients who had hypoglycemic event at least 3 months
* who has can be survey questionnaire
* who can insert continuous glucose monitoring system

Exclusion Criteria:

* renal dysfunction patients
* hepatic dysfunction patients
* who has any kind of diseases, operations, medical treatments that can affect glucose levels
Physicians International Coronary Computed Tomography Angiography (CCTA) Utilization Registry

This protocol describes an observational study whose goal is to collect de-identified Coronary CT Angiography (CCTA) acquisition factors and interpretations (findings) from several hundred U.S. and international imaging facilities. The study uses an electronic data capture tool to collect de-identified CCTA utilization parameters and clinical findings in order to create a multi-center registry. This registry will be used for scientific analysis and publication of pertinent medical trends such as CT utilization, radiation dose, and common cardiovascular findings. The registry will be used to determine areas of interest for future randomized controlled trials.

All data will be collected with patient identifiers removed and in complete accordance with HIPAA regulations. All data will be analyzed in aggregate, thus further minimizing the risk of patient confidentiality violations.


Eligibility Criteria:
Inclusion Criteria:

* Adult participants who are able and willing to consent for themselves
* Patients scheduled for CCTA examination

Exclusion Criteria:

* Patients who did not complete the planned CT imaging procedure due to mechanical error of the CT machine.