cyrilzakka/clinical-trials huggingface dataset:
The Pediatric Anesthesia Quality Improvement Project

The Study is designed to collect information about adverse events that occur in children undergoing anesthesia in participating hospitals. Demographic information will be collected on all anesthetics. An analysis of each adverse event will be performed and entered into the database. From this information we will devise strategies to prevent these adverse events.


Eligibility Criteria:
Inclusion Criteria:

* All children undergoing anesthesia at participating hospitals

Exclusion Criteria:

* Patients over 21 years of age
Safety and Efficacy of T8 on Treating Chronic Abnormal Immune Activation in HIV/AIDS Patients

This is a multicenter, randomized, double-blind, dose-finding, placebo-controlled study in patients with chronic HIV infection and inadequate immune restoration treated with long-term highly active antiretroviral therapy (HAART). A total of 150 eligible subjects will be selected and randomized at a ratio of 1:1:1 into T8 0.5 mg QD, 1 mg QD, and placebo group, with background HAART unchanged, for 48 consecutive weeks.


Eligibility Criteria:
Inclusion Criteria:

1. Chinese subjects aged 18-65, male or female；
2. Subjects with Body mass index (BMI) ≥18 (kg/m2); Male weight ≥50kg, female weight ≥45kg；
3. Subjects must meet the criteria;
4. No birth planning；
5. Understand and sign informed consent form voluntarily.

Exclusion Criteria:

1. allergic constitution；
2. Pregnant or lactating women；
3. Subjects who have been diagnosed with malignant tumors；
4. Subjects whose laboratory tests meet the conditions；
5. Subjects who have been diagnosed with severe gastrointestinal diseases；
6. Subjects who have been diagnosed with severe cardiovascular disease；
7. Subjects who have been diagnosed with severe cerebrovascular disease；
8. Subjects with history of alcohol and drug abuse；
9. Subjects who have participated in any other clinical trial；
10. Subjects who have any conditions that the investigator considers not suitable for this trial.
Effect of Hydration With Sodium Bicarbonate for Long-Term Clinical Outcomes in Patients With Chronic Kidney Disease Undergoing an Emergent Coronary Procedure

This study is to evaluate the efficacy of sodium bicarbonate plus N-acetylcysteine for the prevention of contrast-induced nephropathy.


Eligibility Criteria:
Inclusion Criteria:

* patients with chronic renal failure(serum creatinine \>1.1mg/dl) undergoing elective percutaneous coronary intervention

Exclusion Criteria:

* administered with sodium bicarbonate and/or N-acetylcysteine and/or contrast media within 72 hours.
* pregnancy
* congestive heart failure
* allergy to sodium bicarbonate and/or N-acetylcysteine
* hemodialysis
A Study of IMR-687 in Subjects With Beta Thalassemia

A Study to Evaluate the Safety and Tolerability of IMR-687 in Subjects with Beta Thalassemia

A phase 2, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, PK, and PD of IMR-687 (phosphodiesterase (PDE) 9 inhibitor) administered once daily (qd) orally for 36 weeks in 2 populations of adult subjects with β-thalassemia: Population 1 (Transfusion Dependent Thalassemia (TDT) subjects) and Population 2 (Non-Transfusion Dependent Thalassemia (NTDT) subjects).

Eligibility Criteria:
Inclusion Criteria:

1. Documented diagnosis of β-thalassemia or HbE/ β-thalassemia in their medical history. Concomitant alpha gene deletion, duplication, or triplication is allowed.
2. Documentation of the dates of transfusion events and the number of all pRBC units per event within the 12 weeks prior to the Baseline (Day 1) visit. .
3. Must be willing and able to complete all study assessments and procedures, and to communicate effectively with the investigator and site staff.
4. TDT Subjects: subjects must be regularly transfused, defined as \>3 to 10 pRBC units in the12 weeks prior to Baseline (Day 1) visit and no transfusion-free period for \>35 days during that period.
5. NTDT subjects: Subjects must be transfusion independent, defined as 0 to ≤3 units of pRBCs received during the 12-week period prior to the Baseline (Day 1) visit, must not be on a regular transfusion program, must be RBC transfusion-free for at least ≥ 4 weeks prior to randomization, and must not be scheduled to start a regular
6. hematopoietic stem cell transplantation within 9 months.
7. NTDT subjects: Subjects must have Hb ≤10.0 g/dL at Screening; the screening Hb sample must be collected 7 to 28 days prior to randomization. Hb values within 21 days post-transfusion will be excluded.
8. ECOG performance score of 0 to 1
9. Female subjects must not be pregnant, or breastfeeding and be highly unlikely to become pregnant. Male subjects must be unlikely to impregnate a partner.

Exclusion Criteria:

1. Diagnosis of α-thalassemia (e.g., hemoglobin H \[HbH\]) or hemoglobin S (HbS)/ β thalassemia.
2. Body mass index (BMI) \<17.0 kg/m2 or a total body weight \<45 kg; or BMI \>35 kg/m2
3. Subjects with known active hepatitis A, hepatitis B, or hepatitis C, with active or acute event of malaria, or who are known to be positive for human immunodeficiency virus (HIV).
4. Stroke requiring medical intervention ≤24 weeks prior to randomization.
5. Platelet count \>1000 × 109/L.
6. Participated in another clinical study of an investigational agent (or device) within 30 days or 5-half-lives of date of informed consent, whichever is longer, or is currently participating in another study.
7. For Subjects on iron chelation therapy (ICT) at the time of ICF signing, initiation of ICT less than 24 weeks before the predicted randomization date.
8. Prior exposure to sotatercept or luspatercept, IMR-687, or gene therapy within 6 months prior to randomization (Day 1).
9. Subjects who have major organ damage
Development and Validation of a Deep Learning Model to Predict Distant Metastases in Nasopharyngeal Carcinoma Using Whole Slide Imaging and MRI

An AI model was developed to predict the likelihood of distant metastasis in patients with nasopharyngeal cancer based on pathology slides and MRI scans of the primary tumor. The model was validated using data from multiple centers. It was then applied to patients with advanced stages who were recommended to undergo PET/CT scans based on the NCCN or CSCO guidelines. This AI model can accurately screen patients with high risk of distant metastasis at the time of initial diagnosis to receive PET/CT, avoid excessive examination of patients with low risk of distant metastasis, save medical resources and reduce the economic burden on patients.

An AI model was constructed based on HE-stained pathological sections of the primary lesion and MRI of the nasopharynx and neck to predict the probability of distant metastasis at the first visit, and the AI model was fully verified by multicenter data; the AI model was applied to T3-4 or N2-3 patients who were recommended to undergo PET/CT examination according to the NCCN and CSCO guidelines, and the threshold of the AI model when the negative predictive value for predicting M0 was not less than 95% was determined, providing theoretical support for patients predicted by AI to be exempted from PET/CT examination.

Eligibility Criteria:
Inclusion Criteria:

A. The primary lesion was pathologically confirmed as nasopharyngeal carcinoma (WHO classification is I, II and III); B. The stage was T3-4 or N2-3, and the nasopharynx + neck MRI plain scan and enhanced scan were performed to confirm the nasopharyngeal and cervical lymph node lesions, and PET/CT or conventional examination (chest CT plain scan + enhanced scan, upper abdominal CT or MRI plain scan + enhanced scan or abdominal color Doppler ultrasound or ultrasound angiography, and whole body bone imaging) was performed to screen for distant metastases.

Exclusion Criteria:

Previous history of other malignant tumors (such as other head and neck squamous cell carcinomas, thyroid cancer, breast cancer, esophageal cancer, etc.).
Serum Levels of Vitamin D,Calcium and Magnesium in Preschool Recurrent Wheezers

wheezing" is defined as a musical sound caused by the passage of air through narrow respiratory tract airways . Recurrent wheeze is defined as three or more episodes of parentally reported wheeze in the past 12 months of Various risk factors are associated with recurrent wheezing and asthma: small airway caliber; decreased lung function at birth; viral respiratory infections; environmental pollution; pets; early daycare attendance; passive smoking; parental history of asthma or atopy; obesity; and socioeconomic factors.

There has been growing recognition of the critical extra-skeletal roles for vitamin D in recent years with an explosion of interest in vitamin D across health disciplines including lung disease. Recently, vitamin D was found to be low in patients with recurrent wheezes.

Vitamin D, whether produced in the skin upon sun exposure or ingested from various dietary sources, is converted in the liver to 25-hydroxyvitamin D \[25(OH)D\]. The latter is the major circulating form of vitamin D and is thus used for evaluating the vitamin D status of patients . The flesh of fatty fish (such as salmon, tuna, and mackerel) and fish liver oils are among the best sources of vitamin D and the fortified cereals and milk provide adequate amounts as well.

Studies in animal models and humans have demonstrated an association of low vitamin D concentrations with atopy and respiratory tract conditions. The mechanism that explains this association is still unclear. It has been suggested that this mechanism is due to the effects of vitamin D status on the regulation of the immune system.

The vitamin D receptor is expressed in various cells of the immune system, such as macrophages, monocytes, dendritic cells, and natural killer cells, as well as in B and T lymphocytes. Binding of the active form of vitamin D to its receptor leads to an increase in immunomodulatory activity that maintains the balance between the cellular immune response (Th1) and the humoral response (Th2), in addition to stimulating regulatory T cells.

Hypomagnesaemia (serum Mg level \<0.74 mmol.L-1) has been also suggested to be associated with increased incidence of wheeze, airway hyperreactivity, and impairment of lung function. The mechanisms of action of magnesium (Mg) on respiratory airways are multiple and include relaxation of airways smooth muscle, bronchodilatation, anticholinergic effect, and stabilization of the mast cells

Eligibility Criteria:
Inclusion Criteria:

* Any child with three or more episodes of parentally reported wheeze aged from 1 month to less than 6 years admitted at pediatric department of Sohag University Hospital.

Exclusion Criteria:

* patients with chronic lung and congenital heart diseases.
* Patients with body mass index (BMI) below 3rd percentile and those ≥ 85th percentile will be excluded to avoid effect of disturbed nutritional status on vitamin D level and occurrence of wheezing.
Study to Determine the Response and Effectiveness of RSD1235 in Subjects With Atrial Fibrillation or Atrial Flutter

The purpose of this study is to demonstrate the effectiveness of RSD1235 compared with placebo, in the conversion of atrial fibrillation or atrial flutter to sinus rhythm.


Eligibility Criteria:
Inclusion Criteria:

* Atrial flutter or atrial fibrillation that has been sustained for greater than 3 hours and up to 45 days

Exclusion Criteria:

* Myocardial infarction, acute coronary syndrome or cardiac surgery within 30 days prior to randomization
Pharmacokinetic Study to Characterize Individual Metabolic Profile

The study aims to descibe the pharmacokinetics of 10 substrates of enzymes involved in drug metabolism and their metabolites, after administration singly and simultaenously at predefined doses in 10 health volunteers.

The aim of this study is to test the administration of combination of substrates and thereby to characterise simultaneously the main enzymes and transporters involved in drug metabolism. The doses of substrates administered will first assessed in terms of safety and their appropriateness for determination of pharmacokinetic parameters. Ten volunteers will be used, this number having been defined in view of the aims of this proof-of-concept pilot study,ie,safety and determination of pharmacokinetic parameters. The number was not the result of statistical calculation.

Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers

Exclusion Criteria:

* pregnancy
Addressing Fear and Risk of Vasovagal Reactions Among High School Donors

In this study, high school donors will be asked about their blood donation-related fears prior to their donation. Half of the donors reporting fear will be assigned to a brief coping skills intervention.

In this study the investigators will ask high school donors about their blood donation-related fears prior to their donation. Among those who report donation fear, half will be randomly assigned to receive a brief presentation of coping strategies administered via a computer tablet. The investigators will compare reaction rates and return behavior for the donors and high school drives where the study was conducted to the reaction and retention rates from similar blood drives where no data was collected. The investigators will also examine whether asking about the specific types of fear improves the prediction of syncopal or presyncopal reactions beyond the predictive value of a single fear question. Finally, the investigators will examine whether providing coping information to help manage the fear improves syncopal reaction rates and/or donor retention rates among fearful donors.

Eligibility Criteria:
Inclusion Criteria:

* To be eligible for inclusion in this study, the individual must have presented to donate blood at a New York Blood Center high school blood drive where data is being collected and have passed the health screening process.

Exclusion Criteria:

* Less than 16 years of age; inability to read and comprehend English
Anxiety Reduction in Type 2 Diabetes Through Breathing ExercisesPatients With Type 2 Diabetes

Injection-related anxiety is a significant barrier to the management of type 2 diabetes, adversely affecting treatment adherence and glycemic control. This study investigated the effectiveness of breathing exercises in reducing anxiety during the first insulin injection.

This study is designed as a randomized, double-blind, experimental study. Data from patients who agree to participate in the study was collected by the researcher prior to testing. Variables collected include age, gender, marital status, education level, occupation, body mass index (BMI), HbA1c levels and diabetes duration, as well as scores on the Subjective Disorders Scale (SUDS), State Anxiety Inventory (STAI-I) and Trait Anxiety Inventory (STAI-II). Patients were then randomly assigned to the intervention (BREATH) and control groups using a computer-generated randomization table. Allocation continued until the blocks in each group are equal in size.

Participants in the BREATH and control groups was identified prior to the intervention. All participants completed a form with demographic information. The participants in the control group completed the SUDS, STAI-I and Trait Anxiety Inventory (STAI-II) scales before the test. They then had 30 minutes of free time. The SUDS, STAI-I and STAI-II scales were then completed for the post-test.

In the BREATH intervention group, participants were first instructed on the breathing exercises (at the lowest point of breathing, close the left nostril with the right index finger and exhale through the right nostril). Breathe in through the right nostril, then close it with your thumb and breathe out through the left nostril. This cycle was repeated at least three more times. Participants completed the SUDS, STAI-I and STAI-II scales before the test, following by a single BREATH session (approximately 30 minutes). After the test, the SUDS, STAI-I and STAI-II were administered.

Standard treatment for all patients was not interrupted during the study. Appointments for the randomized patients were made by telephone to avoid encounters and mutual interference between the groups.

Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes diagnosis for at least one year,
* followed up at the diabetes outpatient clinic,
* literate and able to understand and complete study forms,
* first-time insulin injectors in addition to oral antidiabetics,

Exclusion Criteria:

* younger than 18 years
* older than 65 years
* having visual, auditory, or mental impairments that would affect to complete the forms
Comparison of Comparison of Ropivacaine and Liposomal Bupivacaine for Total Knee Arthroplasty

This is a randomized prospective outcomes study comparing two groups of patients. One group will receive liposomal bupivacaine for a periarticular injection. The other will receive ropivacaine for periarticular injection for pain relief after Total Knee Arthroplasty. the primary objective of this study is to determine if liposomal bupivacaine provides superior pain control (decreased maximal pain scores within the first 72 hours post surgery) when compared to ropivacaine when injected in a periarticular injection.

The current standard of care at our institution for pain relief in Total Knee Arthroplasty is ropivacaine injectate into the knee for acute postoperative pain relief. This provides pain relief for a duration of 6-18 hours after surgery. All patients in this study will also receive multimodal analgesia following surgery in both arms of the study. This will be the first study to prospectively analyze these two regimens.

Study group 1 (ropivacaine arm) consist of 100 mL (1 mL ketorolac, 2.5 mL morphine, 28.95 mL normal saline, 300 mcg of epinephrine, and 200 mg ropivacaine) Study group 2 will consist of 100 mL (one syringe with 50 mL total: 40 mL 0.25% bupivacaine, 300 mcg epinephrine, 1 mL ketorolac, 2.5 mL morphine, 6.5 mL normal saline) (one syringe with 50 mL total: 20 mL liposomal bupivacaine 30 mL normal saline). The periarticular injection will occur at the end of the procedure. Adequate analgesia will be defined as \< 3 VAS at rest and if VAS is greater that 3 adjustments in oral or intravenous pain medications. Postoperatively the study team will evaluate for any signs of complications. Pain scores and opioid usage will be recorded daily while the subject is in the hospital. A quality of recovery survey will be completed at 72 hours post injection. All subjects will be contacted by phone at day 14 to determine if there have been any adverse events and report their pain level.

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing primary total knee arthroplasty surgery 18-80.

Exclusion Criteria:

* Patient on chronic anticoagulation
* Allergy to local anesthetics, nsaids, or opioids
* Patients who remain intubated for one week after surgery or who are unable to provide information as to their feelings of pain post-operatively for the first week post- operatively
* Daily use of opioid for more than three weeks
* Lack of patient cooperation
Comparison of Facet Oscillatory Mobilization and Mobilization With Movement in Chronic Mechanical Neck Pain

The study compares Facet Oscillatory Mobilization and Mobilization with Movement in managing chronic mechanical neck pain, aiming to determine the effectiveness of these techniques in pain, range of motion, and disability.

This study will be Conducted as a randomized controlled trial, it will include 32 participants divided into two groups receiving different mobilization techniques along with conventional physical therapy. Outcome measures such as the Numeric Pain Rating Scale (NPRS), Neck Disability Index (NDI), and Inclinometer will be used to assess changes over a two-week intervention period with a follow-up after one month.

Eligibility Criteria:
Inclusion Criteria:

* complaint of Chronic Mechanical neck pain ( more than 6 weeks).
* Neck Disability Index (NDI) score more than 16%
* Age between 35-45 years, Both Male and Female
* NPRS score more than 3-6.
* Recurrent neck pain aggravated at least once in the month.
* Painful Cervical ROM (Flexion less than 80, Extension less than 70, rotation less than 90 to both sides and lateral flexion less than 35 degree.

Exclusion Criteria:

* Cervical radiculopathy
* Cervical canal stenosis
* Severe neurological disorder
* Previous cervical surgery
* Recent history of fall/trauma to the cervical spine.
Efficacy Study of Vitamin D Supplementation to Meticillin Resistant Staphylococcus Aureus (MRSA) Carriers

The purpose of this study is to treat persistent MRSA carriers with vitamin D supplementation during a 12 month to see if the number of MRSA positive patients can be reduced.


Eligibility Criteria:
Inclusion Criteria:

1. Persistent MRSA-carriers as defined as 2 MRSA-positive bacterial cultures from at least one location, at least 3 months apart and during 3 years prior to inclusion.
2. Men and women aged ≥18-75
3. Signed 'informed consent'
4. Negative pregnancy test (U-hcg) and have to accept the use of adequate anti-conceptive method (contraceptives, hormone/copper-spiral).

Exclusion Criteria:

1. Should not be on vitamin D supplementation at least 6 months prior to inclusion.
2. Serum level of 25-hydroxy vitamin D3 \>75 nmol/L
3. Ongoing and continuous antibiotic treatment. The patient should be off antibiotics at least 30 days prior to inclusion
4. Known sarcoidosis
5. Primary or secondary hyperparathyroidism
6. Kidney failure as defined as a normal age-adjusted creatinin.
7. Long term systemic treatment with corticosteroids or other immunosuppressive medication
8. Taking thiazides
9. Hypercalcaemia (verified by a laboratory result younger than 2 month)
10. Ongoing malignancy disorder
11. If plans to leave the Stockholm county within 12 months of inclusion
12. History of kidney stones
13. Pregnancy (ongoing or planned)
14. Breastfeeding women
15. Taking part of another clinical study involving drugs
16. Hypersensitivity to cholecalciferol and/or any of the excipients
17. Other criteria that could jeopardize the study or its intention as judged by the investigator