cyrilzakka/clinical-trials huggingface dataset:
Long-term Renal Prognosis of Neonatal Acute Kidney Injury

The goal of this observational study is to conduct a multicenter, prospective neonatal acute kidney injury (AKI) follow-up cohort to describe the clinical characteristics of chronic kidney disease (CKD) in AKI cases within 1 year of follow-up and screen for effective biomarkers that can early warn of CKD progression. Ultimately, a neonatal AKI adverse prognosis warning model based on multidimensional data will be established to provide new data and new models for CKD management.


Eligibility Criteria:
Inclusion Criteria:

* Delivered in this hospital and subsequently admitted to the NICU during the study period;
* Diagnosed with neonatal AKI according to the 2015 KDIGO neonatal AKI criteria;
* Age \<28 days.

Exclusion Criteria:

* Severe hydronephrosis diagnosed by prenatal renal ultrasound;
* Patients with congenital urinary malformations, including solitary kidney, cystic dysplasia, multicystic dysplastic kidney, renal dysplasia, and obstructive uropathy;
* Newborns who required congenital heart surgery within the first 7 days after birth;
* Newborns whose mothers had a history of renal failure;
* Death within 48 hours after birth;
* Other genetic syndromes or medical conditions were not eligible for inclusion according to the attending neonatologist's judgment.
Early Oral Hydration After Thoracoscopic Surgery

The goal of this clinical trial is to learn about the safety and feasibility of early oral hydration in patients receiving video-assisted thoracoscopic surgery after general anesthesia. The main questions aims to answer:

* the safety and feasibility of oral hydration supplementation in the recovery room following general anesthesia.
* the degree of improvement in sore throat and dry mouth after oral hydration.
* the side effects and risks of oral hydration supplementation, such as the incidence of postoperative nausea and vomiting.
* the impact of oral hydration supplementation in the recovery room following general anesthesia on hemodynamics.
* patient satisfaction with oral hydration supplementation in the recovery room following general anesthesia.

Participants will receive a series of oral hydration from swab moistening, and ice cube hydration to water hydration in the recovery room. Researchers will compare with the standard, no-hydration group to see if it is safe and feasible to hydrate patients in the recovery room.

Anesthesiologists assess the removal of the endotracheal tube post-surgery and the patient is then transferred to the recovery room for rest. The principal investigator will evaluate the consciousness status and risk of nausea and vomiting to confirm eligibility for the trial. Subsequently, the following grouping will be conducted:

1. Experimental group

   * First, moisten the patient's throat with a cotton swab dipped in water. If no nausea or vomiting occurs after five minutes, proceed to the next stage.
   * Provide an ice cube for the patient to hold in their mouth. If no nausea or vomiting occurs after ten minutes, proceed to the next stage.
   * Offer 10-20ml water for the patient to drink under medical supervision. If no nausea or vomiting occurs and the patient requests more water, administer 10-20ml of water every ten minutes, assessing for any adverse effects each time. The total water intake should not exceed 500ml.
2. Comparison group - standard care without any intervention

Evaluate the level of throat pain using VAS (Visual Analogue Scale) score, the incidence, timing, frequency of post-operative nausea and vomiting, the level of mouth dryness, the satisfaction of patients in recovery room, and the vital signs.

Eligibility Criteria:
Inclusion Criteria:

* Males and females aged 18 to 70.
* Anesthesia physical status classification III or below
* Body Mass Index 30 or below
* Elective video-assisted thoracoscopic surgery

Exclusion Criteria:

* Pre-operative throat pain
* Impaired mental status
* Tendency to choke (inc. dysphagia, stroke hx.)
* Nil Per Os (NPO) less than 8 hours
* Pregnancy
* Nausea and vomiting in Operating room or Post-anesthesia care unit
The Efficacy and Safety of Venostan in Promoting Postoperative Swelling Reduction in Patients With Ankle Fractures

This study is a multicenter, open-label, randomized controlled trial planned to enroll patients with ankle fractures who meet the inclusion and exclusion criteria and are scheduled to undergo internal fixation surgery from the emergency and inpatient wards of multiple hospitals. General and disease-related data will be collected. All eligible patients must voluntarily sign an informed consent form after understanding and accepting the study. Successfully recruited participants will undergo internal fixation surgery at a scheduled time and then be randomly assigned to either the Venostan (horse chestnut seed extract tablet) group or the conventional treatment group. They will receive the corresponding treatments according to the study protocol. Follow-up assessments will include changes in ankle circumference, ankle range of motion, scale evaluation results, laboratory test results, and adverse events. The study aims to evaluate the effects of Venostasin in patients with ankle fractures undergoing internal fixation surgery, exploring its potential to promote postoperative reduction of ankle swelling, enhance early joint function recovery, and investigate its safety in postoperative fracture management.


Eligibility Criteria:
Inclusion Criteria:

* ≥18 year old, no gender restriction;
* Diagnosed with ankle fracture confirmed by imaging data, AO classification: ---AO-43, AO-44-F3, AO-44;
* Scheduled to undergo open reduction and internal fixation surgery;
* Voluntary signing of the informed consent form.

Exclusion Criteria:

* Pregnant or lactating women;
* With contraindications to surgery;
* With other severe combined injuries or soft tissue infections;
* Severe multiple trauma: Injury Severity Score (ISS) \> 16;
* With concurrent fractures of the spine, pelvis, or ipsilateral or contralateral lower limbs;
* Pathological fractures;
* With peripheral vascular disease or deep vein thrombosis (DVT);
* With severe impairment of heart, lung, liver, or kidney function or abnormal coagulation function;
* Unable to walk independently before the injury;
* With pre-existing lower limb edema (e.g., due to liver cirrhosis, kidney disease, etc.) before the injury;
* With mental disorders or hyperalgesia;
* Allergic to any component of the investigational drug;
* Any contraindications that limit clinical evaluation and treatment of the patient;
* Deemed unsuitable for inclusion in this study by the investigator.
Evaluation of Pneumococcal Vaccine Formulations in Elderly

The purpose of this observer-blind study is to evaluate the safety, reactogenicity and immunogenicity of pneumococcal vaccines in elderly. Subjects will be vaccinated twice with an interval of two months.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who the investigator believes will comply with the requirements of the protocol should be enrolled in the study.
* Male or female subjects between, and including, 65 and 85 years old at the time of the first vaccination, in relatively stable health.
* Written informed consent obtained from the subject.

Exclusion Criteria:

* Previous vaccination against Streptococcus pneumoniae (with a licensed vaccine or with an investigational candidate vaccine).
* Vaccination with diphtheria/tetanus toxoids within one month preceding the first dose of study vaccine.
* Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period or participation to another pharmaceutical/vaccine study.
* Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
* Planned administration/administration of a vaccine not foreseen by the study protocol within 30 days of the first dose of study vaccine, with the exception of the influenza vaccine which can be administered at least 7 days preceding or at least 7 days following any vaccine dose.
* Administration of immunoglobulins and/or any blood products within the last 3 months.
* Bacterial pneumonia within 3 years prior to 1st vaccination.
* Invasive pneumococcal disease (I.P.D) within 3 years prior to 1st vaccination.
* History of thrombocytopenia or bleeding disorder.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
* History of reactions or allergic disease likely to be exacerbated by any component of the vaccine.
* History of administration of an experimental/licensed vaccine containing MPL or QS21.
* Current serious neurologic or mental disorders.
* Inflammatory processes such as known chronic active infections (e.g. Hepatitis B, C).
* All past or current malignancies (excluding non-melanic skin cancer) and lymphoproliferative disorders diagnosed or treated actively during the past 5 years.
* Acute disease at the time of enrolment.
* Physical examination positive for acrocyanosis, jaundice, splenomegaly
* Acute or chronic, clinically significant anaemia, pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by history, physical examination or laboratory screening tests at the discretion of the investigator.
* Laboratory evidence of haematological abnormalities.
* Laboratory evidence of biochemical abnormalities.
* History of chronic alcohol consumption and/or drug abuse.
* Other conditions that the principal investigator judges may interfere with study findings.
A Study To Compare Pharmacokinetics Of Dacomitinib (PF-00299804) Between Healthy Subjects And Subjects With Mild And Moderate Hepatic Impairment

The study will determine if there are differences in how dacomitinib is absorbed and eliminated between healthy subjects and subjects with mild and moderately impaired hepatic function.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects of non-childbearing potential between the ages of 18 years of age to \<75 years of age. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests. Liver function tests, albumin and prothrombin time must be within normal range.
* Body Mass Index (BMI) of 18 to 35 kg/m2;
* An informed consent document signed and dated by the subject.
* Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
* Subjects in the normal hepatic function group (Group 1): No known or suspected hepatic impairment.
* For subjects in the hepatic impairment groups (Groups 2 and 3):

  * Should satisfy the criteria for Class A or B of the modified Child-Pugh classification
  * A diagnosis of hepatic dysfunction due to hepatocellular disease (and not secondary to any acute ongoing hepatocellular process) documented by medical history, physical examination, liver biopsy, hepatic ultrasound, CT scan, or MRI.
  * Stable hepatic impairment, defined as no clinically significant change in disease status within the last 30 days, as documented by the subject's recent medical history
  * Must be on a stable dose of medication and/or treatment regimen.

Exclusion Criteria:

* Any condition possibly affecting drug absorption (eg, gastrectomy, chronic diarrhea, rapid transit).
* A positive urine drug screen.
* Females of childbearing potential, including those with tubal ligation. \[To be considered for enrollment, women of at least 45 years of age who are postmenopausal (defined as being amenorrheic for at least 2 years) must have confirmatory FSH test results at screening\].
* In addition, subjects in the hepatic impairment groups (Groups 2 and 3) presenting with any of the following will not be included in the trial:

  * Hepatic carcinoma and hepatorenal syndrome or life expectancy \<1 year.
  * Undergone porta-caval shunt surgery.
  * History of gastrointestinal hemorrhage due to esophageal varices or peptic ulcers less than one month prior to study entry.
Comparison Between Elliptical Domed Mesh Technique and Lichtenstein Technique in Inguinal Hernia

The investigators describe a new surgical technique for inguinal hernia open repair, which will be compared with the Lichtenstein technique. The investigators seek to find the difference between the two techniques in postoperative pain.

The investigators randomly assigned 168 adult patients with uncomplicated primary inguinal hernia to two treatment groups:

Group A: 84 patients treated with the new technique Group B: 84 patients treated with the technique of Lichtenstein (gold standard) The investigators reviewed the patients operated on one week, one month, three months and six months after surgery. The investigators evaluated the presence of moderate to severe pain in each technique, as well as the intensity of pain, measured by visual analogue scale.

The investigators also determined the presence of inguinal dysesthesias in each technique, measured by dermatome mapping.

Eligibility Criteria:
Inclusion Criteria:

* adult patients diagnosed with uncomplicated primary inguinal hernia
* mentally healthy patients
* patients without preoperative groin pain
* patients eligible for outpatient surgery

Exclusion Criteria:

* patients with different surgical diagnosis
Comparative Bioavailability Study of Synerx and Verelan PM 300 mg Verapamil HCl ER Capsules Under Fed Conditions

The purpose of this study is to determine the bioequivalency of Synerx Pharma Verapamil extended release capsules.

The purpose of this study is to determine if Synerx Pharma Verapamil HCl ER Capsules are bioequivalent to Verelan PM capsules in healthy volunteers under food effect conditions.

Eligibility Criteria:
Inclusion Criteria:

Healthy adult male or female volunteers, 18-55 years of age. Subjects will be continuous non-smokers for at least 3 months prior to the first dose.

Weighing at least 60 kg for males and 52 kg for females and within the normal range according to accepted normal values of the Body Mass Index Chart (18.00 -28.00 kg/m2).

Medically healthy subjects with clinically normal laboratory profiles, vital signs and ECGs.

Absence of any exclusion criteria during history, physical, or laboratory evaluation.

Confirmation that all female subjects are not pregnant by a certified, validated pregnancy test.

Females of childbearing potential should either be sexually inactive (abstinent) for 14 days prior to the first dose and throughout the study or be an acceptable birth control method Postmenopausal women with amenorrhea for at least 2 years will be eligible. Give voluntary written informed consent to participate in the study.

Exclusion Criteria:

History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease.

In addition, history or presence of: alcoholism or drug abuse within the past year; hypersensitivity or idiosyncratic reaction to verapamil, other calcium ion influx inhibitors or any other component of the product formulations; idiosyncratic reaction to acetaminophen; malabsorption within the past year; recurrent headaches or migraines. Presence of a medical condition requiring regular treatment with prescription drugs.

Tests giving reasonable suspicion of a disease that would contraindicate taking an investigational drug or that might affect the interpretation of the results of the study.

Female subjects who are pregnant or lactating. Subjects who tested positive at screening for HIV, HbsAg or HCV. Positive test results for drugs of abuse or alcohol. Subjects whose sitting blood pressure is less than 110/60 mmHg at screening or 100/55 mmHg prior to dosing in each period.

Subjects whose pulse is lower than 55 b.p.m. at screening or 50 b.p.m. prior to dosing in each period.

Subjects whose PR interval is \>190 msec at screening and \>200 msec prior to dosing in each period.

Subjects whose QTc interval is \>450 msec at screening and prior to dosing in each period.

Subjects who have used any drugs or substances known to be strong inducers and/or inhibitors of CYP enzymes within 28 days prior to the first dose.

Subjects who have been on a special diet during the 28 days prior to the first dose and throughout the study.

Subjects who donated 50 to 499 mL of blood within 30 days and more than 499 mL within 56 days prior to the first dose.
A Study to Evaluate Safety of Exposure to Wegovy During Pregnancy

This is an observational, prospective Wegovy (semaglutide 2.4 milligram \[mg\]) Pregnancy Registry Study. The aim of this study is to compare the maternal, foetal, and infant outcomes of pregnant women who are exposed to Wegovy during pregnancy for the treatment of obesity or overweight with at least one weight-related comorbid condition with outcomes in an internal comparison cohort of pregnant women with obesity or overweight with at least one weight related comorbid condition at conception and who are not exposed to Wegovy or other glucagon-like peptide-1 receptor agonists (GLP-1 RAs) during pregnancy. Infant outcomes will be assessed throughout the infant's first year of life, with active data collection by the registry occurring at 4 and 12 months after delivery.


Eligibility Criteria:
Inclusion Criteria:

* Signed consent obtained before any study-related activities
* Female 15-50 years of age at the time of signing consent
* Currently or recently pregnant
* Resident of country included in the study
* Authorisation for her HCP(s) to provide data to the registry
* Exposed to Wegovy cohort: Exposure to at least one dose of Wegovy at any time during pregnancy for the treatment of obesity or overweight with at least one weight-related comorbid condition.
* Unexposed to Wegovy cohort: Have obesity or overweight with at least one weight related comorbid condition at conception

Exclusion Criteria:

* Mental incapacity, unwillingness, or language barriers precluding adequate understanding or cooperation
* Unexposed to Wegovy cohort: Exposure to Wegovy or other GLP-1 RA at any time during pregnancy
Non-inferiority Study Comparing daVinci Skills Simulator to Mimic dV-Trainer for Preparing Residents to Perform Live Human Surgery

The objective of this study is to determine whether a group of resident physicians otherwise naïve to robotic surgery can demonstrate equal levels of proficiency during their first robotic supracervical hysterectomy having received training either with the Mimic dV-Trainer or the daVinci Skills Simulator.


Eligibility Criteria:
Inclusion Criteria:

* Obstetrics and gynecology or general surgery residents in ACGME accredited programs naïve to robotic surgery training
* Completion of the online orientation to daVinci Surgical System

Exclusion Criteria:

* Performance of any robotic surgical procedures as the console surgeon
* Performance of any robotic simulator protocols
* Any significant amount of time spent on a virtual reality robotic simulator
Study of Qiliqiangxin Capsule to Treat Dilated Cardiomyopathy

The pathogenesis of dilated cardiomyopathy (DCM) leading to heart failure is closely associated with autoimmunity dysfunction. A few studies represented that Qiliqiangxin capsule, a Chinese medicine, could enhance heart function in chronic heart failure and regulate the balance of TNF-a and IL-10 in myocardial infarction. In this study, to explore the effects of Qiliqiangxin capsule on the improving heart function and immunoregulation in patients with DCM, patients were recruited, anti-heart autoantibodies and some representative cytokines were assayed by enzyme-linked immuno sorbent assay (ELISA), and the efficacy of heart function improvement was compared between Qiliqiangxin capsule and placebo under the standard treatment of DCM.


Eligibility Criteria:
Inclusion Criteria:

* Dilated Cardiomyopathy (LVEF ≤ 45%)

Exclusion Criteria:

* Secondary dilated cardiomyopathy (such as ischemic cardiomyopathy, valvular cardiomyopathy, hyperthyroid cardiomyopathy, diabetic cardiomyopathy, anemia cardiomyopathy, and etc.)
* Coronary heart disease
* Rheumatic heart disease
* Pulmonary heart disease
* Continuous dysarteriotony: hypertension(systolic blood pressure \[SBP\] ≥ 60mmHg/diastolic blood pressure \[DBP\] ≥ 100mmHg); hypotension(SBP \< 90mmHg/DBP \< 60mmHg)
* Resting heart rate ≤ 50bpm
* Atrioventricular block patients without permanent pacemaker
Post-Market Study of the ICONACY Hip System

The purpose of this study is to evaluate the use and efficacy of the Iconacy Hip System for total hip replacement surgery.


Eligibility Criteria:
Inclusion Criteria:

* This must be a primary hip replacement on this hip
* Patient is 30 years of age or older
* Have hip joint disease related to one or more of the following: degenerative joint disease, including osteoarthritis or traumatic arthritis
* Patient is likely to be available for evaluation for the duration of the study
* Able and willing to sign the informed consent and follow study procedures

Exclusion Criteria:

* Is younger than 30 years of age
* If there has been a total hip replacement on this hip in the past (no revisions allowed in study)
* Infection, or history of infection, acute or chronic, local or systemic
* Alcoholism or other addictions
* Muscular, neurological or vascular deficiencies which compromise the affected extremity
* Obesity(BMI\>45)
* Insufficient bone quality
* Loss of ligamentous structures
* High levels of physical activity
* Materials sensitivity
* Prisoner
* Mental conditions that may interfere with the patient's ability to give an informed consent or willingness to fulfill the study requirements
* Patient is pregnant
* Is not able to read English language
Safety Study of BMS-986165 in Healthy Subjects and to Treat Psoriasis

The purpose of this study is to establish if BMS-986165 is safe and effective at treating autoimmune diseases. BMS-986165 which has shown some promise in preclinical studies for inhibiting autoimmune conditions. This study will be the first time this drug is given to humans, and will be conducted entirely in healthy subjects. It will be run in 4 Parts. Part A will investigate single oral doses of drug. Part B will investigate giving the drug daily for 14 days. Part C will investigate daily doses for 14 days in healthy volunteers with Japanese decent. Part D will investigate whether food, stomach acidity or giving the drug in a capsule makes a difference to the safety and potential use of this drug.


Eligibility Criteria:
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Healthy Male and Female participants
* 18 to 50 years of age (Parts A-D)

Exclusion Criteria:

* Participants that had recent infections
* Participants with low blood pressure or increased heart rate
* Participants with any chronic health related problems
* Participants with active cancer within the last 5 years
* Participants with any other major medical illness