cyrilzakka/clinical-trials huggingface dataset:
Determination of Exercise Behavior in Patients With Juvenile Idiopathic Arthritis

Juvenile idiopathic arthritis (JIA) is one of the most common rheumatic diseases in childhood, affecting at least 1 in 1000 children. Children with JIA experience joint inflammation and swelling, pain and tenderness, morning stiffness, limited mobility. Children with JIA complain pain and have lower functional ability and decreased quality of life compared with their peers. Many studies have reported that patients with JIA have low physical activity levels and also exercise therapy is considered an important component of the treatment of JIA. Nowadays, studies for evaluating exercise behaviours in order to cope with physical inactivity for many chronic diseases are becoming increasingly important.The objective of this study is to determine exercise behaviour in patients with JIA.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed as JIA according to ILAR classification
* Aged between 6-18
* Adequate cognitive function for understanding questions

Exclusion Criteria:

- a parent who does not have a smartphone
Comparison of Mucin Levels at the Ocular Surface of Visual Display Users With and Without Dry Eye Disease

The study aimed to evaluate 1) if levels of the glycocalyx membrane mucins, including MUC1, MUC4, MUC16 and MUC20, are altered in conjunctival cells of visual display users With and Without Dry Eye Disease, and 2) if mucin levels correlate with dry eye clinical diagnostic data.

The cross-sectional study aimed to evaluate 1) if levels of the glycocalyx membrane mucins, including MUC1, MUC4, MUC16 and MUC20, are altered in conjunctival cells of visual display users With and Without Dry Eye Disease, and 2) if mucin levels correlate with dry eye clinical diagnostic data.

Eligibility Criteria:
Inclusion Criteria:

* Participants who exposed to video display terminals for more than 1 year (at least 5 days per week and 6 hours per day) were enrolled and divided into two groups: (1) VDT users with DED and (2) VDT users without DED. DED was diagnosed according to the Tear Film and Ocular Surface Society (TFOS) DEWS II criteria: (1) Ocular Surface Disease Index (OSDI) score ≥ 13 and (2) one of these signs; fluorescein tear breakup time (TBUT) \<10 sec; abnormal ocular surface staining (\>5 corneal spots or \> 9 conjunctival spots).

Exclusion Criteria:

* a history of contact lens wear or ocular surgery within 2 year of the study visit; a history of previous ocular disease; topical or systemic therapies other than artificial tears within two weeks before recruitment; and inflammatory ocular diseases, ocular surface diseases, glaucoma and systemic diseases with ocular involvement, such as meibomian gland dysfunction, diabetes, and peripheral neuropathy.
Peritoneal Dialysis Registration System (PERSIST)

Brief Summary: The investigators are registering all PD patients at recruited hospitals and developing a PD database in China. Patients will be followed up every 3 months, and both baseline and follow-up information will be collected and input into the registration system. The patient survival, technical survival, peritonitis rate, longitudinal changes of residual renal function and peritoneum function, and quality of life for PD patients, etc, will be compared using the PD database.

Detailed Description: The investigators are registering all end stage renal disease (ESRD) patients receiving peritoneal dialysis (PD) treatment, and developing a PD database in China. Patients' demographic characteristics (including age, gender, height, weight, BMI, smoking, drinking, and education, etc), clinical characteristics (primary cause of ESRD, dialysis prescription, patient's condition and lab measurements of serum, urine, and dialysate), drug information, complications and scores of quality of life at the baseline will be collected. Patients will be followed up every 3 months. Demographic and clinical characteristics, complications, drug information of patients will be collected at each visit. The patients' clinical outcomes, such as mortality (including all-cause mortality and cardiovascular disease mortality), technical survival, kidney transplantation, transfer to hemodialysis, hospitalization, occurrence of peritonitis, etc. were also followed up till the end of the study. The data of patient survival, technical survival, peritonitis rate, hospitalization rate, clinical lab parameters, longitudinal changes of residual renal function and peritoneum function, peritonitis rate, hospitalization rate, clinical lab parameters and quality of life for PD patients will be analyzed using the PD database.

Eligibility Criteria:
Inclusion Criteria:PD patients -

Exclusion Criteria:No

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Education Session to Improve Program Adherence

To examine is user knowledge of a dietary self-monitoring (DSM) calorie tracking app and improving patient adherence to daily caloric food intake to help with weight loss.

The research question guiding this project is: In adults with a BMI greater than 25 kg/m2, does a 1-hour education session on using a calorie-tracking application improve adherence to a calorie-restricted weight management program over eight weeks? This project aimed to increase patient knowledge with the DSM tool. To Increase adherence to the calorie-restricted diet program and, finally, to increase weight loss in the program participants of the 8-week program

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and older with a Body Mass Index (BMI) greater than 25 kg/m2

Exclusion Criteria:

* Younger than18 years of age with a Body Mass Index (BMI) less than 25 kg/m2
Protective Manual Hyperinflation in Acute Mechanically Ventilated Trauma Patients

This single-blinded randomized study aims to compare two methods of manual hyperinflation (protective - moderate tidal volumes with positive end expiratory pressure) and non-protective (large tidal volume and no positive end expiratory pressure) in ventilated acute trauma patients, to investigate the effect on inflammatory markers, lung compliance, oxygenation and sputum volume.

Current evidence in mechanical ventilation supports a "protective lung strategy" that is, smaller tidal volumes and prevention of loss of positive end expiratory pressure (PEEP). There is concern that manual hyperinflation (MHI) may conflict with this strategy and cause volutrauma and atelectrauma potentially leading to biotrauma.

This single-blinded randomized study aims to compare two methods of manual hyperinflation (protective - moderate tidal volumes with positive end expiratory pressure) and non-protective (large tidal volume and no positive end expiratory pressure) in ventilated acute trauma patients, to investigate the effect on inflammatory markers, lung compliance, oxygenation and sputum volume.

Eligibility Criteria:
Inclusion Criteria:

* Trauma patients
* Day 1 of admission to intensive care
* Mechanically ventilated

Exclusion Criteria:

* Pre-existing lung disease
* PEEP \> 12.5cmH20
* Nitric oxide in circuit
* Haemodynamically unstable
* Undrained pneumothorax
* Intracranial pressure \> 25mmHg
The Ultrasonographic Changes of Intercostal Muscles and Diaphragm in Mechanically Ventilated Preterm Neonates

Invasive mechanical ventilation induces ventilator induced diaphragmatic dysfunction particularly when used for long time and Intercostal muscles as well contribute to the important work of respiratory movement by expanding the thorax , and determining the thickness of them would be a useful parameter in evaluating respiratory muscle activity.

This study will add the impact of mechanical ventilation on the diaphragm and intercostal muscles in preterm infants using ultrasound.


Eligibility Criteria:
Inclusion Criteria:

1. Preterm infants from 28-36 weeks gestation
2. In need for invasive mechanical ventilation according to work of breathing, oxygen saturation and blood gases .

Exclusion Criteria:

* 1) Significant congenital anomalies including cardiac, abdominal or respiratory.

  2) Congenital anomalies involving the diaphragm. 3) Phrenic nerve paralysis. 4) Congenital muscular dystrophies. 5) Major upper or lower airway anomalies. 6) Storage diseases.
Anterior Spinal Canal Reconstruction and Fusion Surgery for Treating Degenerative Cervical Kyphosis With Stenosis

Degenerative cervical kyphosis with stenosis (DCKS) is a common cervical spine degenerative disease, causing pain, numbness, and weakness of limbs, which seriously affect the quality of life of the patient. Surgery is an effective way to treat this condition, however, the best surgical procedure is still controversial. Anterior spinal canal reconstruction and fusion surgery (ACRF) is a new surgical procedure that previously proposed by our team, it combines the advantages of both the conventional anterior and posterior approach. The purpose of this study is to evaluate the safety and effectiveness of ACRF surgery for treating DCKS. A multicenter prospective randomized controlled trial was designed. Eligible patients will be randomly divided into three groups, including the ACRF group, the conventional anterior surgery group, and the conventional posterior surgery group. Demographic data, surgery Information, and follow-up results will be collected and compared between groups.


Eligibility Criteria:
Inclusion Criteria:

* Patients are diagnosed with degenerative cervical kyphosis with stenosis
* Patients aged between 30 and 70 years
* Patients meet the indications for surgery
* Patients submitted written informed consent

Exclusion Criteria:

* Tumor, infection, or trauma of the cervical spine
* Severe cervical kyphosis that greater than 50°
* Severe ossification of the posterior longitudinal ligament of the cervical spine
* Patients with ankylosing spondylitis
* Previous surgery of the cervical spine
Calcium and Phosphorus Whole-Body Balance and Kinetics in Patients With Moderate Chronic Kidney Disease

This pilot study aims to develop a method for simultaneous whole-body calcium and phosphorus balance and full kinetic modeling of both ions in patients with chronic kidney disease.

The goal of this project is to produce preliminary data on the effects of the commonly prescribed dietary phosphorus restriction on whole-body Calcium (Ca) and Phosphorus (P) balance and kinetics patients with CKD, to support a larger future clinical study. The specific aims are to determine intestinal Ca and P fractional absorption and 2) Ca and P balance and full kinetics, effect sizes variance estimates in patients with CKD on a low Ca diet with high P diet versus dietary P restriction. The hypothesis is that a high P diet, in the context of a typical low Ca diet, leads to P retention negative Ca balance, and that dietary P restriction modestly reduces P retention but does not negative Ca balance.

The study design is a randomized 2-period cross-over study. All outpatient and inpatient visits place at the Indiana CTSI Clinical Research Center located in IU Health University Hospital in Indianapolis, IN. Subjects will be randomly assigned to controlled diets of either low Ca/high P (LCa/HP) or low (LCa/LP) for a 1-week, outpatient diet equilibration period, followed by 1-week inpatient full balance that includes a 48-hour Ca and P absorption testing protocol. After a 1-3 week washout subjects will crossover to the other diet regimen

Eligibility Criteria:
Inclusion Criteria:

* Men or women, ages 30-75 years old, any race or ethnicity
* Moderate chronic kidney disease
* Female subjects must be postmenopausal (\>12 months since last menstrual period), surgically sterile, or confirmed not pregnant by pregnancy test
* Must be on stable doses of medications (except those noted in exclusion criteria) for at least 4 weeks prior to the study
* Willing to discontinue nutritional supplements (e.g. vitamin D, calcium, multivitamin/minerals, or others) upon enrollment until completion of the study
* Adequate vitamin D status defined as serum 25D \> 20 ng/mL

Exclusion Criteria:

* Plans to initiate dialysis within 6 months
* Hypercalcemia defined as serum calcium \>10.5 mg/dL within past 3 months
* Hyperkalemia defined as serum potassium \>5.5 mg/dL within past 3 months
* Hyperphosphatemia defined as serum phosphate \>5.5 mg/dL within past 3 months
* Intestinal disease that alters absorption or normal intestinal function including celiac disease, small bowel resection, or bariatric surgery
* Serious, uncontrolled underlying systemic disease including diabetes, lupus, hypertension
* Pregnant or breastfeeding
* Prescribed a phosphate binder medication, calcitriol, vitamin D analogs, calcimimetics, parathyroid hormone analogues, and other medications that may alter Ca and P metabolism within past 30 days
Comparing of Cefazolin Plus Azithromycin Versus Cefazolin in Prevention of Febrile Morbidity After Emergency Cesarean Delivery

Cesarean section is the common surgery in world wide. But the complication like febrile morbidity such as surgical site infection, fever, urinary tract infection and endometritis can be occurred even giving the standard antibiotics. Therefore if wider bacterial spectrum coverage antibiotic like azithromycin is added to the standard antimicrobial prophylaxis(1st generation cephalosporin), the incidence of febrile morbidity could be reduced. We will compare the regimen of cefazolin plus azithromycin and standard regimen of cefazolin alone in prevention of febrile morbidity after emergency cesarean section.

This study was designed to evaluate the effect of azithromycin on the incidence of febrile morbidity after the emergency cesarean section. The standard antimicrobial prophylaxis which is recommended by the ACOG is the 1st generation cephalosporin intravenously only but some of the bacteria that can cause the febrile morbidity after cesarean section wouldn't be killed by the 1st generation cephalosporin. The antibiotic that can cover them is macrolide group antibiotic such as azithromycin. Therefore this study will compare the regimen of standard antimicrobial prophylaxis and the regimen of standard antimicrobial prophylaxis with azithromycin intravenously in preventing the febrile morbidity after emergency cesarean section. Control group will receive the 1st generation cephalosporin intravenously and the intervention group will receive the 1st generation cephalosporin with azithromycin 500mg intravenously. Primary outcome is febrile morbidity which assessed at postoperative day 3. The definition of the febrile morbidity in this study is including surgical site infection, endometritis, urinary tract infection and fever alone. Secondary outcomes are febrile morbidity at postoperative day 7 and day30, neonatal outcome and adverse effect from azithromycin use.

Eligibility Criteria:
Inclusion Criteria:

1. Singleton pregnancy with a gestation of 24 weeks or more
2. Undergoing non-elective cesarean delivery during labor or rupture of membrane more than 4 hr
3. No allergy to macrolide such as azithromycin and clindamycin
4. Provide informed consent
5. Partner of participant allows the patient to participate the research

Exclusion Criteria:

1. Use of azithromycin within 7 days before enrollment
2. Chorioamnionitis or other infection requiring postpartum antibiotic therapy (except for antibiotics for group B streptococcus)
3. Liver disease (Cirrhosis or AST more than 3 times the upper normal limit)
4. Serum creatinine level of more than 2.0 mg/dL or need dialysis
5. Diarrhea at the time of enrollment
6. Maternal heart disease
7. Use of medication known to prolonged the QT interval
A Study to Investigate the Pharmacokinetic Drug Interactions Between Dutasteride and Tadalafil in Healthy Male Subjects

This is open-Label, A Randomized, Crossover study to evaluate the safety and pharmacokinetic interaction after oral concomitant administration of Dutasteride and Tadalafil in healthy male volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Age 19 to 45 years
* BMI score 19 kg/m2 to 28 kg/m2
* SBP \< 140 mmHg and ≤ 90 mmHg or DBP \< 90 mmHg and ≥ 50 mmHg
* Eligible according to the laboratory results of hematology, blood chemistry and urinalysis
* Voluntarily signed the informed consent form

Exclusion Criteria:

* Gastrointestinal diseases or surgery which may affect absorption of the investigational products within 6 months
* History of hypersensitivity
* History of Cardiovascular disease
* History of degenerative Retina disease
* Lactose intolerance
* History of vision loss
* Clinically significant disorders of allergy, drug hypersensitivity reaction, hepatobiliary system, kidney, neurology, respiratory, hemato-oncology, endocrine, dermatology, urology, ophthalmology, psychiatry, musculo-skeletal system, immunology, otorhinolaryngology, and cardiovascular system
* Donated whole blood (transfusion, apheresis etc..) within 60 days
* Participated and administered the investigational products in other clinical trial within 90 days
* Taking drugs which may affect Clinical trial within 30 days
* Excessive alcohol consumption (\> 3 units/week, 1 unit)
* Taking food which may affect Clinical trial within 7 days
* Positive result from Urinary test, Serum test
* Not eligible due to other reasons including laboratory results
* Clinically significant disorders result from Electrocardiography test
* Not eligible due to investigator's judgments
A Phase I Study of QL1604 in Subjects With Advanced Solid Tumors

This is a first-in-human (FIH), dose-escalation, PK expansion, monotherapy efficacy expansion, and open-label phase I clinical study assessing the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary efficacy of QL1604 injection （a humanized anti-PD-1 monoclonal antibody）in patients with advanced solid tumors.


Eligibility Criteria:
Inclusion Criteria:

1. Volunteer to participate in this clinical study; completely understand and know this study as well as sign the informed consent form (ICF);
2. Age ≥ 18 years and ≤ 70 years when ICF is signed;
3. Pts with histologically or cytologically confirmed advanced solid tumors;
4. At least one target lesion as defined per RECIST Version (v) 1.1;
5. Subjects who have disease progression or intolerable reactions after the currently available standard anti-cancer treatment previously received or refused prior cancer therapy regimen(s) ;
6. Eastern Cooperative Oncology Group performance status of 0 or 1;
7. Life expectancy of greater than 12 weeks;
8. Adequate hematologic and organ function;
9. Female subjects who are not pregnant or breastfeeding
10. Male and female subjects able to have children must agree to use highly effective method of contraception throughout the study and for at least 120 days after last dose;

Exclusion Criteria:

1. Known hypersensitivity to any monoclonal antibody, QL1604 and/or any of its excipients;
2. Active autoimmune disease that has required systemic treatment, replacement therapy is acceptable;
3. Subjects with major cardiovascular and cerebrovascular diseases;
4. Any condition that required systemic treatment with either corticosteroids (\> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before the first dose of study drug;
5. Subjects who have received surgery, radiotherapy, chemotherapy, targeted therapy, other anti-tumor treatments, or participating in other clinical studies is less than 4 weeks before the first administration of investigational product;
6. Received a live vaccine;
7. Infection with human immunodeficiency virus (HIV);
8. Known psychiatric or substance abuse disorders that would interfere with the requirements of the study;
9. History or current evidence of any condition, therapy, or laboratory abnormality, that might confound the results of the trial, or interfere with the participant's participation for the full duration of the study, or investigators/sponsor consider the subjects are not suitable for this trial.
Effectiveness of Nitrous Oxide in the ED

This will be a randomized control trial. All patients for whom an emergency provider determines that abscess drainage or laceration repair are necessary will be considered for enrollment. The provider must be willing to participate in the study and be certified to use Nitrous oxide. The investigators providers completed a training course to be certified to use Nitrous oxide. The patient must be age 18 or greater, consent to participate in the study, and be able to complete a satisfaction survey. If the patient states there is a possibility of pregnancy, the investigators will regress to our standard of care and perform a urine pregnancy test. Patients with a first trimester pregnancy will be excluded. Patients who agree to enroll in the study will be randomized to Nitrous oxide versus oxygen (to be administered through the same system), and will complete a survey after the procedure, as will the provider. There will be a separate block randomization for each procedure. Providers may select other agents of choice for analgesia/sedation, such as local anesthesia, and pain medications, based on their clinical judgment. If the patient appears to have inadequate analgesia during the procedure, the provider can elect to treat as is typically done (pain medications or local anesthetics) at their discretion. The survey will ask patients to give a self-reported pain score before and during their procedure (both to be completed after the procedure). It will also ask the patient/guardian and provider for a satisfaction level with the analgesia during the procedure. In addition, side effects and procedure start and stop time will also be documented. In addition to the survey, the investigators will document clinical characteristics including diagnosis, size of laceration or abscess, additional medications required and dosages, comorbidities, age, and gender. Other data that will be gathered will include which adjunctive analgesics/anesthetics were used.


Eligibility Criteria:
Inclusion Criteria:

Patients with:

* A laceration or an abscess requiring primary repair or incision and drainage respectively, per the treating provider

Exclusion Criteria:

* Age \< 18 years
* First trimester pregnancy
* Inability to obtain written informed consent from subject or surrogate
Physician Led Counseling in Management of Depression in Type 2 Diabetes Mellitus

There is a high prevalence of depression in patients with diabetes mellitus. Depression has been shown to be associated with poor self-management (adherence to diet, exercise, checking blood glucose levels) levels in patients with diabetes.To determine whether enhancing quality physician's care for depression improves both depression and diabetes outcomes in patients with depression and diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Eligible patients are ambulatory,
* Had adequate hearing to complete a telephone interview,
* Diabetic patients screened for depression

Exclusion Criteria:

* Currently in care with a psychiatrist;
* Diagnosis of bipolar disorder or schizophrenia;
* Use of antipsychotic or mood stabilizer medication
* Mental confusion on interview, suggesting significant dementia.