cyrilzakka/clinical-trials huggingface dataset:
Dietary Interventions Evaluating Transport of Uric Acid Across the Tubules

The purpose of the study is to determine whether low fat dairy diet reduces serum uric acid levels.

Uric acid plays a role not only in the pathogenesis of gout but is also a predictor of cardiovascular disease, hypertension and renal disease in man. We have identified the human urate ion channel transporter (hUAT), located in the proximal convoluted tubule of the kidney that is involved in both the secretion and reabsorption of urate across the tubule. This channel has a unique lectin binding site that in in-vitro studies, has been found to be modulated by glucose, galactose and lactose. We have also identified a mutation (G/A polymorphism) in our laboratory, that in in-vitro studies has demonstrated diminished hUAT channel activity. Cross-sectional studies have earlier shown that uric acid levels vary with serum glucose levels. Studies have also reported that a low-fat dairy diet reduces the incidence of gout, while others have shown that this diet reduces blood pressure significantly when compared with a non-dairy diet. We hypothesize that the effect of blood glucose levels in lowering uric acid levels is through the regulation of hUAT channel activity. We also hypothesize that a low-fat dairy diet reduces serum uric acid levels through hUAT regulation leading to a decrease in the incidence of gout and a reduction in blood pressure levels. In our proposed randomized, controlled, cross-over trial in healthy adult volunteers, we aim to study the effect of a low-fat dairy diet and a non-dairy diet on serum uric acid levels, the renal fractional excretion of uric acid and blood pressure. We will also study the effect of an acute intravenous infusion of glucose on these parameters. DNA analysis for hUAT mutations of study subjects will be done to assess if there is a blunted response of hUAT activity in subjects with the polymorphism as compared to normal individuals.

Eligibility Criteria:
Inclusion Criteria:

* • Healthy adult volunteers

  * Coronary artery disease
  * Glucose intolerance or Diabetes(a fasting blood sugar of less than 100 mg/dl as per the American Diabetes Association guidelines)
  * CHF
  * Gout
  * Lactose intolerance
  * Milk allergy
  * Women who are pregnant or lactating
  * Subjects who are on any medications except birth control pills
  * Subjects who drink more than 3 servings of beer or liquor per week.
  * Normal blood pressure ( less than 120 mmHg systolic and 80 mmHg diastolic)
  * Normal serum UA levels
  * Normal renal funcion (calculated GFR \>90ml/min)

Exclusion Criteria:

* • Coronary artery disease

  * Glucose intolerance or Diabetes(a fasting blood sugar of less than 100 mg/dl as per the American Diabetes Association guidelines)
  * CHF
  * Gout
  * Lactose intolerance
  * Milk allergy
  * Women who are pregnant or lactating
  * Subjects who are on any medications except birth control pills
  * Subjects who drink more than 3 servings of beer or liquor per week
Efficacy and Safety of HRS-7535 Tablets in Obese Subjects .

The aim of this trial is to evaluate the efficacy and safety of HRS-7535 in Chinese Obese Subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female subjects, 18-65 years of age at the time of signing informed consent;
2. At screening and random visit, 28.0 ≤BMI≤ 40.0 kg/m2;
3. Diet and exercise control for at least 3 months before screening and random visit, and less than 5 % self-reported change within the last 3 months.
4. Able and willing to provide a written informed consent

Exclusion Criteria:

1. Presence of clinically significant lab or ECG results that may affect the evaluation of the efficacy or safety of the study drug at screening visit;
2. Uncontrollable hypertension;
3. PHQ-9 score ≥15;
4. History of diabetes;
5. History of acute cardiovascular and cerebrovascular diseases within 6 months prior to screening;
6. Any organ-system malignancies developed within 5 years except for cured local basal cell cancer of the skin and in-situ cancer of the cervix;
7. Confirmed or suspected depression, bipolar disorder, suicidal tendencies, schizophrenia, or other serious mental illness;
8. Use of any medication or treatment that may have caused significant weight change within 2 months;
9. History of bariatric surgery;
10. history of blood donation or blood loss in the 3 months before screening, or blood transfusion in the 2 months before screening;
11. Surgery is planned during the trial;
12. Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method;
13. Researchers and relevant staff of the research Centre or other people directly involved in the implementation of the programme, and their immediate family members.
Effect of Spinal Ketorolac After Acute Opioid Exposure

This research study is being done because pain is a significant problem for patients with a variety of medical problems and following surgery or traumatic injury. Currently available pain medications may not treat all types of pain or may treat pain only at doses that produce side effects and complications. The medication in this study may have a role in better treatment of pain. The goals of this study are to see if a dose of ketorolac (non-narcotic, pain reliever), given into the fluid in the back near the spine has any effect on pain or discomfort in the skin sensation that will take place after applying capsaicin (chili pepper) cream. The sunburn-like sensation that people experience after having capsaicin cream applied is similar to, but much milder than, the pain that some people have after surgery and after certain types of nerve injuries. This study will test the effects of combining two medications that are often given together to control postoperative pain or pain from a nerve injury. The investigators are especially interested in answering two questions about the effects of ketorolac (non-narcotic pain reliever) and remifentanil (intravenous \[IV\] narcotic painkiller):

1. How much does remifentanil (narcotic painkiller) affect the sunburn-like painful area on your skin, which develops after applying capsaicin cream?
2. What pain relieving effects does spinal ketorolac have when given with IV remifentanil?

Intravenous (IV) remifentanil stimulates spinal COX activity, leading to increased Cerebrospinal fluid CSF) prostaglandin E2 (PGE2) concentrations and areas of capsaicin-induced mechanical hypersensitivity after remifentanil infusion, and these effects will be blocked by intrathecal ketorolac.

Areas of mechanical hyperalgesia and allodynia will be established by topical capsaicin + intermittent heat in healthy volunteers, who will be randomized to receive intrathecal saline or ketorolac during remifentanil infusion, with primary outcome measure area of hyperalgesia and secondary outcome measure Cerebrospinal fluid (CSF) prostaglandin E2 (PGE2) concentration after stopping remifentanil.

Eligibility Criteria:
Inclusion Criteria:

* healthy
* American Society of Anesthesiologist (ASA) I or II classification
* between the ages of 18-55
* weigh less than 250 pounds
* without chronic pain

Exclusion Criteria:

* taking analgesics in the last 2 weeks
* positive urine drug screen
* pregnancy
* currently taking any prescription antidepressants or other medications that are mood altering
* liver or kidney disease
* stomach ulcers
* allergies to ketorolac, lidocaine, or capsaicin cream
* lung disease (COPD)
Online Cognitive Rehabilitation of Executive Dysfunction in Nonamnestic MCI

Nonamnestic mild cognitive impairment (naMCI) is a prodromal state characterized by deficits in executive functioning, a collection of higher-order abilities involved in organization, planning, inhibition, and complex reasoning. Research shows that individuals with naMCI have an increased risk of developing non-Alzheimer's dementia such as frontotemporal dementia and dementia with Lewy bodies, which pose substantial personal and societal costs. Accordingly, interventions that can successfully slow down or reverse the course of naMCI are needed.

Goal Management Training (GMT) is a cognitive rehabilitation platform that has been studied extensively, applied clinically, and manualized into kits for clinicians (Levine et al., 2000; Levine et al., 2007; Levine et al., 2011; Stamenova \& Levine, 2019). The purpose of GMT is to train individuals to periodically "STOP" what they are doing, attend to task goals, evaluate their performance, and monitor or check outcomes as they proceed. Recently, an online version of GMT has been developed and validated in order to circumvent barriers to attending in-person sessions.

The purpose of the current study is to determine if the online version of GMT is effective at improving self-reported executive dysfunction in individuals diagnosed with naMCI against a control group that is receiving treatment-as-usual from their care provider. It is hypothesized that, compared to the control group, individuals receiving GMT will report a decrease in executive function deficits.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of nonamnestic mild cognitive impairment
* Available to participate in all testing and intervention sessions
* Access to a computer
* Computer familiarity
* Normal or corrected-to-normal vision and hearing

Exclusion Criteria:

* Diagnosis of amnestic mild cognitive impairment or dementia
* Moderate to severe affective impairment defined by score above cut-off for depression on the Patient Health Questionnaire-9 (PHQ-9; Kroenke et al., 2001)
A Study of IBI363 in Subjects with Advanced Solid Malignancies

This is a Phase 2, open-label, multicenter study designed to evaluate the efficacy, safety and tolerability of IBI363 (study drug) in subjects with advanced, refractory solid malignancies.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects have the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol;
2. Male or female subjects ≥ 18 years old;
3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1;
4. Anticipated life expectancy of ≥ 3 months;

Exclusion Criteria:

1. Inadequate bone marrow and organ function;
2. Received previous anti-tumor therapy: Any chemotherapy or targeted small molecule therapy (standard or investigational) within 2 weeks or 5 plasma half-lives. Received Nitrosoureas and mitomycin C within 6 weeks prior to first dose of study drug and during study; Any anti-cancer monoclonal antibody (mAb) within 4 weeks prior to first dose
3. Received live vaccines within 28 days prior to first administration of the study drug or plan on receiving any live vaccine during the study;
4. Has adverse reactions resulting from previous antitumor therapies, which have not resolved to Grade 0 or 1 toxicity according to NCI-CTCAE v5.0 (except for alopecia, fatigue, pigmentation and other conditions with no safety risk according to investigator' discretion) or baseline prior to the first dose of the study drug;
5. Undergone major surgery (Craniotomy, thoracotomy or laparotomy, and other surgery according to investigator' discretion, excluding needle biopsy) within 4 weeks prior to the first dose of the study drug, or who are expected to undergo major surgery during the study period, or who have severe unhealed wounds, trauma, ulcers, etc.
Help in the Emergency Room to Detect Organ Dysfunction

The purpose of this prospective, non-interventional clinical study is to assess the clinical validity of a number of markers (including Heparin Binding Protein (HBP), Procalcitonin (PCT), C-reactive protein (CRP), White cell count (WCC) and lactate) for indicating the presence of organ dysfunction, or outcome, of patients with organ dysfunctions following emergency department admission or hospitalization. Secondary objectives are to identify novel putative biomarkers and to identify risk factors for negative long-term effects of acute critical illness The HBP assay is an enzyme-linked immunosorbent assay (ELISA) for the quantitative determination of Heparin Binding Protein in human plasma.


Eligibility Criteria:
Inclusion Criteria:

i) ≥18 years of age ii) 1 or more of the following criteria: Saturation\<90% without oxygen or \<93% with oxygen or reported saturation\<90%, Respiratory frequency \>25/min, Altered mental awareness, Heart rate \>120/min, Systolic blood pressure \<100 mm Hg. iv) informed consent.

Exclusion Criteria:

None
Comparison of Desflurane Anesthesia Versus TIVA-TCI in Patients Undergoing Ophthalmic Ambulatory Surgery

This is a single-center, randomized, prospective research which aims to investigate the advantages and disadvantages between desflurane balanced anesthesia and TIVA-TCI with propofol in ophthalmic ambulatory surgery, so that to evaluate a better anesthesia method in ophthalmic surgery through a large sample clinical study.

Desflurane balanced anesthesia and TIVA-TCI(Total IntraVenous Anesthesia-Target Controlled Infusion) are commonly used in ophthalmic ambulatory surgery, however, there is no clear evidence to discriminate the advantages and disadvantages between them. This study is designed to evaluate a better anesthetic method in ophthalmic surgery through a clinical study. This is a single center, randomized, prospective study. 200 patients with American Society of Anesthesiologists'(ASA) physical status 1 to 2, aged 18 to 60, scheduled for elective strabismus ambulatory and in whom a LMA is indicated for anesthesia are recruited. Enrolled patients are randomly assigned into 2 groups: group TIVA (TIVA-TCI with propofol) and group Des (Desflurane).In group TIVA, anesthesia is maintained with propofol and remifentanil. Propofol is continuously administered via a target-controlled infusion (TCI) pump intraoperatively. In group Des, anesthesia is maintained with desflurane.All patients received anaesthesia depth monitoring with bispectral index (BIS). The dose of anesthetic is adjusted to maintained the BIS value within 40 to 60. At the end of the surgery, inhalant anesthetic or infused propofol and remifentanil are discontinued. LMA is removed when patient regains consciousness with spontaneous respiration. Patients are then transferred to the post anesthetic care unit (PACU) for postoperative follow-up. The primary outcome is awake time, the secondary outcomes include discharge time, the stay time in PACU, time of off-bed, Riker sedation agitation score (SAS), time of PADSS\>9, NRS score when leaving PACU, incidence of various complications (postoperative nausea and vomiting (PONV), emergence agitation, etc), as well as anesthesia cost. All patients are followed up by calling in one day after the surgery.

Eligibility Criteria:
Inclusion Criteria:

* 18-60 years patients undergoing selective ophthalmic ambulatory surgery；
* ASA I and II
* duration of anesthesia at least 30min
* without apparent organ comorbidities
* sign the informed consent form

Exclusion Criteria:

* equal or greater than ASA III
* has a history of dementia，psychiatric disorders or central nervous system diseases
* taking sedatives, antidepressant or glucocorticoid
* without family members
* has cardiac, respiratory，liver，kidney comorbidities
* uncontrolled hypertension（\>180/100mmHg）
* laryngeal mask fail to insert, and change to tracheal intubation
Clinical Study of 18F-FAPI-RGD PET/CT in Rheumatoid Arthritis

The goal of this observational study is to learn about 18F-FAPI-RGD PET/CT imaging in assessing rheumatoid arthritis disease activity. Participants will undergo clinical evaluation and 18F-FAPI-RGD PET/CT examination.

Patients with rheumatoid arthritis who met the 2010 American College of Rheumatology/European League against Rheumatism Rheumatoid arthritis classification criteria will be included. All patients will be assessed for disease activity and the clinical disease activity Index (cDAI) was calculated. Blood sedimentation rate and CRP assay results will be collected. All patients will undergo 18F-FAPI-RGD PET/CT examination. The correlation of cDAI, ESR and CRP levels with PET joint count and PET joint index as measured by 18F-FAPI-RGD PET/CT will be statistically analyzed.

Eligibility Criteria:
Inclusion Criteria:

* Patients with rheumatoid arthritis who meet the 2010 American College of Rheumatology/European League Against Rheumatism Rheumatoid arthritis classification criteria.

Exclusion Criteria:

* A. Patients with malignant tumors and other rheumatic immune diseases; B. clinical and conventional radiographic inspection of materials; C. researchers think not suitable for other information to participate in this study.
Relationship Between Delirium Severity by CAM-ICU 7 and 4C Mortality Score of the COVID-19 Patients in ICU

Aim: to investigate whether the 4C Mortality score, which measures the severity of COVID-19, and the CAM-ICU 7 score , which measures the severity of delirium, in ICU. To compare two scores in terms of the number of days without intubation and 28 day mortality rates in ICU.


Eligibility Criteria:
Inclusion Criteria:Patients hospitalized in the intensive care unit diagnosed with COVID-19 will include in the study

Exclusion Criteria:there is no exclusion criteria
Immune Status After Being on Call for 24 Hrs

Sleep deprivation is a prevalent problem in modern societies. Sleep deprivation can cause hormonal changes, such as an increase in cortisol, as well as inflammation. Animal studies have shown an increase in inflammatory cytokine production following sleep deprivation. Additionally, humans experiencing sleep deprivation may experience a decrease in natural killer cells and lymphocytes.

Physicians, particularly those in surgical specialties, are often subjected to sleep deprivation as part of their medical residency training. This study hypothesizes that after 24-hour shifts, there is an increase in inflammatory response and impairment of the immune response against unspecific activation. This proposal aims to provide insight into the impact of sleep deprivation on the immune system of surgery residents by characterizing the phenotype and function of immune cells, as well as their correlation with biometric data.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects
* Surgery residents in a 24-hour shift rotation
* Gender of subjects: Males and females
* Age of subjects: 18 years old and older
* Racial and Ethnic Origin: Any race or ethnicity

Exclusion Criteria:

* Unwilling/unable to sign informed consent
* Vulnerable Subjects/Subject Capacity to provide consent
Efficacy and Safety of Histamine Human Immunoglobulin in the Treatment of Chronic Spontaneous Urticaria (CSU)

The goal of this clinical trial is to study patients with chronic spontaneous urticaria. The main question it aims to answer is the efficacy and safety of histamine human immunoglobulin (ShuYangMinNing) in the treatment of chronic spontaneous urticaria.


Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent must be obtained before any assessment is performed；
2. Age ≥ 18 years；
3. Meet the diagnostic criteria of chronic spontaneous urticaria from《Guideline for diagnosis and treatment of urticaria in China（2022）》and follow the doctor's advice；the patient had urticaria symptoms in the previous week before enrollment, and UAS7 score(range 0-42) ≥ 7;
4. Patients with uncontrolled urticaria are regularly treated with standard single-dose antihistamines regularly for 2 weeks before screening;

Exclusion Criteria:

1. Pregnant or nursing (lactating) women;
2. Patients with malignant tumors, severe liver and kidney diseases, hematological disorders, autoimmune diseases(such as systemic lupus erythematosus, Sjogren's syndrome, dermatomyositis, myositis, systemic vasculitis, systemic sclerosis, rheumatoid arthritis, spondyloarthropathy or other rheumatic immune diseases evaluated by the physician that are not suitable for inclusion), chronic serious infections, diabetic peripheral neuropathy, psychosis, and other diseases or medical histories that may affect normal efficacy evaluation and/or subject safety evaluation；
3. History of drug or alcohol abuse;
4. Patients who discontinue systemic use of glucocorticoids and other immunosuppressants(such as cyclosporin A, wilfordii , etc.) that affect immune function for less than 4 weeks;Patients who discontinue systemic use of biologics (e.g., omalizumab) for less than 3 months;
5. Patients with symptoms of urticaria and/or angioedema, Including but not limited to urticaria vasculitis, serum sickness like reaction, bullous pemphigoid, mastocytosis, neutrophilic urticaria dermatosis, Schnitzler syndrome, autoinflammatory response syndromes (e.g., tumor necrosis factor receptor-associated periodic fever syndrome, familial Mediterranean fever, mevaldate kinase deficiency, etc.);or other chronic itchy skin conditions, such as atopic dermatitis, dermatitis herpetiformis, and pruritus senile;
6. Allergic to human immunoglobulin;
7. History of other severe allergic reactions;
8. Patients with pathological arrhythmias and a history of organic heart disease; Patients with known or suspected QT prolongation; or patients who are unable to discontinue medications that cause QT prolongation during the trial；
9. Subjects whom the investigator considers unsuitable for other reasons.
Effect of Teledermatology on Length of Hospital Admission, Length of Stay, 30 Day Readmission Rate, and Antibiotic Use in Patients Presenting With Cellulitis vs Pseudocellulitis in an Academic ED Setting

The effect of teledermatology on length of hospital admission, length of stay, 30 day readmission rate, and antibiotic use in patients presenting with cellulitis vs pseudocellulitis in an academic emergency department setting.

The Investigator hope to determine if the implementation of teledermatology in the emergency department (ED) at The Ohio State University Wexner Medical Center is beneficial in diagnosing cases of cellulitis and pseudocellulitis conditions. Prior studies have indicated that misdiagnosis may occur in up to 28% of patients in the ED with these conditions. Additionally, dermatological consults have been shown to change diagnosis or management of these conditions in more than 60% of the patients examined. Without the use of teledermatology, however, a dermatological consult would be prohibitively expensive and take time to obtain. The investigator proposes that by utilizing teledermatology in emergency rooms, the investigator can make faster, yet just as accurate, dermatological diagnoses in patients presenting with cellulitis-like symptoms. Subsequently, by reducing the number of misdiagnoses, unnecessary use of antibiotics and hospitalizations will also decrease, lowering health care costs and simultaneously providing patients with faster treatment of the actual dermatologic condition.

Eligibility Criteria:
Inclusion Criteria:

* Over 18
* Present to the ED with cellulitis-like symptoms, including but not limited to the following: tenderness, redness, swelling, expansive lesion

Exclusion Criteria:

* pregnant
* prisoner
Implementation of a New Motor Skill Learning Therapeutic Device in Children With Cerebral Palsy Rehabilitation

Study of the efficiency of a new interactive interface to apply all the therapeutic principles of motor skill learning used in high dosage intensive interventions. Investigation of its effects on motor, functional and neuroplastic changes in children after high and low dosage intensive interventions using or not the interface.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of unilateral cerebral palsy
* MACS level I, II or III
* GMFCS level I, II, III

Exclusion Criteria:

* unstable seizure
* cognitive deficit that prevent understanding of simple games
* botulinic toxin injection, surgery, or another unusual intervention in the 6 months preceding the study and for the duration of the study