cyrilzakka/clinical-trials huggingface dataset:
Enteral Zinc to Improve Growth in Infants at Risk for Bronchopulmonary Dysplasia

Multiple factors contribute to growth failure in infants with BPD, including poor nutrient stores, inadequate intake, increased losses, and increased needs. Furthermore, compared to infants without BPD, those with BPD have increased resting metabolic rates and energy expenditure. Growth deficits manifest as lower weight, length, and head circumference, as well as changes in body composition. These deficits precede the development of BPD and persist post-discharge. While similar rates of growth are observed in very low birth weight infants with and without BPD once receiving equal calories, catch up growth does not occur in the BPD group. Thus, early growth deficits remained uncompensated.

After iron, zinc is the most metabolically active trace element in the human body. It has a critical role in growth, through its actions on growth hormone, IGF-1, IGFBP-3, and bone metabolism. Prematurity is a risk factor for zinc deficiency, as 60% of zinc accretion occurs in the third trimester. Impaired intake and absorption or excess excretion can further increase this risk. Finally, periods of rapid growth, as seen in preterm infants, increase the need for zinc.

Biochemically, zinc deficiency is defined by a serum zinc level less than 55mcg/dl. However, while zinc depletion is associated with deficiency, the opposite may not be true. For example, in starving patients, clinical symptoms of zinc deficiency occur during re-feeding, suggesting overall requirements are related to needs, regardless of overall zinc status. This may be the case in preterm infants, who may have a subclinical deficiency despite serum zinc level. Thus, zinc deficiency should be considered in infants with poor growth despite receiving adequate protein and calories.

The objective of this study is to determine whether enteral zinc supplementation leads to improved growth in infants at risk for bronchopulmonary dysplasia (BPD). The investigator's hypothesis is that enteral zinc supplementation in very preterm infants at high risk for BPD will significantly improve growth compared to standard of care.


Eligibility Criteria:
Inclusion Criteria:

1. 23 0/7 to 29 6/7 weeks GA
2. Birth weight 501 to 1000g, inclusive
3. 14 to 28 days of life, inclusive
4. 14 day BPD risk score ≥ 50% for death or moderate-severe BPD, calculated using the algorithm on the Neonatal Research Network website (https://neonatal.rti.org/index.cfm?fuseaction=BPDCalculator.start).-

Exclusion Criteria:

1. Major congenital and/or chromosomal anomalies
2. Inability to reach 80ml/kg/day enteral feeds by 28 days of life
Tunisian National Registry on Psoriasis

National cross-sectional multicentric study to describe the epidemiological characteristics of patients with Psoriasis in Tunisia

PsoTReg is a Tunisian, descriptive, non-interventional, multicenter and cross-sectional clinical study performed in dermatology departments and outpatients clinics, of both public and private sectors. The study will enroll hospitalized and ambulatory patients with psoriasis disease, by successive inclusions until the end of the recruitment period, set at six months.

A Scientific Committee validates the scientific writing, a Steering Committee supervises the clinical operations of the project.

Collected data are managed by the DACIMA Clinical Suite®, the electronic data capture platform which complies with the FDA 21 CFR part 11 requirements (Food and Drug Administration 21 Code of Federal Regulations part 11), the HIPAA specifications (Health Insurance Portability and Accountability Act), and the ICH standards (International Conference on Harmonisation). A local authorization by the National Agency of Personal Data Protection will be obtained prior to study kick-off.

Eligibility Criteria:
Inclusion Criteria:

* Patients with psoriasis
* Informed and written consent

Exclusion Criteria:

* Any dermatology disease other than psoriasis
Tocilizumab Augmentation in Treatment-Refractory Major Depressive Disorder

This proposed study sets out to examine the antidepressant effects of tocilizumab among patients with treatment-refractory major depression.

As the understanding of the complex relationship between pro-inflammatory cytokines (specifically interleukin-6 \[IL-6\]) and depression symptoms becomes clearer, clinical trials to evaluate effective and novel treatments are needed. As there have been no published tocilizumab trials among patients with major depression, this pilot study will adopt a single-arm, open-label design. Due to the notion that inflammatory cytokines may play a role in a sub-type of depression, this study will recruit patients with treatment refractory major depressive disorder, for whom established depression treatments have not been effective. In conducting this trial, the investigators seek to examine the potential role of tocilizumab as an augmentation agent, with the hypothesis that it could reduce depression symptomatology in patients with major depression who have not experienced symptom reduction through more traditional antidepressant therapies.

Eligibility Criteria:
Inclusion Criteria:

* Current diagnosis of major depressive episode
* Hamilton Depression Rating Scale (HDRS) score of \>20
* In treatment for depression for a minimum of 8 weeks

Exclusion criteria:

* Active drug or alcohol disorder in the last three months
* History of psychosis, mania or hypomania
* Acute suicide or homicide risk
* History of liver disease including HCV and HBV
* HIV
* History of heart disease or a heart attack
* Active or latent tuberculosis, a history of a positive tuberculosis test, or having received the Bacillus Calmette-Guérin (BCG) vaccine
* Epilepsy or a history of seizures
* Abnormal thyroid-stimulating hormone (TSH \<0.4 or \>5.0mlU/L)
* Abnormal liver function tests on screening (ALT\>50 U/L or AST\>50 U/L)
* Low absolute neutrophil count (ANC) on screening (\<4000/mm3
* Abnormal white blood cell count (\<4,500 or \> 10,000mcL)
* Low platelet count on screening (\<150,000/mm3
* Patients with an active or recent infection, for example cellulitis, bacteremia, pneumonia, and pyelonephritis.
* Recent exposure to uncommon infections (e.g. histoplasmosis, blastomycosis, coccidiomycosis) through recent travel to the Ohio and Mississippi River Valleys and the Southwest
* Pregnant women, breastfeeding women or women of child-bearing age not using contraception
* History of or current autoimmune disease, including multiple sclerosis and inflammatory bowel disease
* Diagnosis of chronic fatigue syndrome
* Temperature greater than 100.3F at the screening visit or any subsequent visits
* Dyslipidemia
* Currently taking oral steroids
* Currently taking statins
* Chronic aspirin or NSAID takers
* Currently taking any immunomodulating medications
* Inability to consent due to cognitive impairment
Ready and Healthy for Kindergarten

This study pilot tests a family wellness program that promotes academic and physical readiness for school among Latino dual language learners using a mixed methods and community engaged approach.

The investigators propose a pilot randomized controlled trial with wait list control to pilot test a family wellness program designed for Latino dual language learners entering Kindergarten and their families. The investigators will recruit up to 48 parent-child dyads to participate in the study. Families will be randomly assigned to session one beginning in June 2022 or session two beginning in July 2022. The investigators will examine the feasibility and acceptability of the family wellness program as well as preliminary effects on parenting behaviors and child language and literacy skills.

Eligibility Criteria:
Inclusion Criteria:

* Primary caregiver of a child entering Kindergarten (4-6 years old),
* Primary caregiver identifies as Hispanic/Latino/Latinx,
* Family speaks Spanish at home,
* Cell phone ownership,
* Willing to receive texts, and
* Willing to accept randomization

Exclusion Criteria:

* Children with multiple congenital anomalies or genetic disorders and previously identified developmental delays will be excluded.
Postoperative Pain in Children Aged From 3 to 5 Years Following Full Mouth Dental Rehabilitation Under General Anesthesia. A Cross-sectional Study. Rehabilitation Under General Anesthesia

the purpose of this study is monitoring Postoperative pain in Children Aged from 3 to 5 years following Full mouth Dental Rehabilitation under General Anesthesia

The study's investigators will record all data related to the immediate postoperative period during the child's stay in the post anesthetic recovery room (PAR).

Just prior to discharge home, the child's discomfort will be measured using Face, Legs, Activity, Cry, and Consolability Pain Assessment Tool (FLACC).

Postoperative data is collected by the same investigator who contacted caregivers by phone at 4 postoperative times: 1, 3, 7, and 30 days after the DRGA using The Dental Questionnaire.

When a participant cannot be reached on the scheduled day, the information is collected on the nearest subsequent day.

The postoperative assessment included: the questioner and an inquiry about the use of medications; the child's ability to eat a regular diet; and "mouth-related" complaints other than dental discomfort.

Dental discomfort is assessed in this study by 2 scales:

the FLACC (Table 1) and The Dental Questioner (Table 2).

FLACC pain assessment tool. The FLACC scale was originally developed to quantify postoperative pain in infants from 2 months old to children up to 7-years-old.(7) This scale assesses 5 aspects of behavior: (F) facial expression; (L) leg movement; (A) activity; (C) cry; and (C) consolability. The range for the total score is from 0 (no pain) to 10 (intense pain). The examiner is standardized to use of the FLACC by a PAR nurse who was experienced in scoring pain with this scale.

The Dental Questioner. The questionnaire covered the following items: did the Child have pain, bleeding from dental origin, sore throat, fever, vomiting, inability to eat, sleepiness, drowsiness, cough, nausea or psychological changes?

Eligibility Criteria:
Inclusion Criteria:

* Egyptian dental children undergoing full mouth dental rehabilitation under general anesthesia (3-5 years old )
* Children selected from pediatric dentistry and dental public health department Faculty of dentistry Cairo University
* Children with no developmental delay.
* Children with normal physical status.
* Parents who can be communicated well

Exclusion Criteria:

* Parents refusing participation in the study.
* Parents who cannot be communicated well
* Children with developmental abnormalities
Defibrillation in Accidental Hypothermia

Hypothermia (core temperature ≤35°C) is a frequent and life-threatening complication after mountain accidents, near-drowning, and intoxications, and can provoke arrhythmia, reduced cardiac contractility, and cardiac arrest. The hypothermic heart may be insensitive to defibrillation with a core temperature \<30°C. Also, below \<30°C after successful defibrillation, a perfusing rhythm often degenerates to ventricular fibrillation (VF) again. Repeated defibrillation can induce myocardial injury. Thus, the guidelines of the European Resuscitation Council (ERC) suggest delaying further defibrillation attempts until the core temperature is \>30°C if VF persists after 3 shocks. Epinephrine should be withheld if core temperature is \<30°C. Advanced Life Support (ALS) guidelines of the American Heart Association (AHA) state that it may be reasonable to perform further defibrillation attempts according to the standard algorithm and to consider administration of a vasopressor during cardiac arrest (Table 1). This discrepancy between ERC and AHA guidelines can be explained by the different interpretations of mainly animal data, which show that vasopressors increase the chances of successful defibrillation \<30°C, defined as return of spontaneous circulation (ROSC) for at least 30 seconds. The guidelines of the Wilderness and Environmental Medicine Society (WMS) state that a single shock at a maximum power can be given for patients with a temperature \<30°C.

The aim of this study is to evaluate clinical course of hypothermic patients(\<30°C) undergoing defibrillation. The primary aim is to evaluate the success ratio of defibrillation, defined as ROSC for at least 30 seconds. Secondary aims are the recurrence rate of ventricular fibrillation, the number of defibrillation attempts per patient, the presence of cardiac dysfunction after defibrillation and the cerebral performance category (CPC) score at the end of hospitalization.


Eligibility Criteria:
Inclusion Criteria:

- patients of the International Hypothermia Registry with a defibrillation while having a body core temperature equal or less than 30°C

Exclusion Criteria:

* patients of the International Hypothermia Registry with a body core temperature \>30°C
* patients who refused to participate
Healthy Directions After Lung Surgery Pilot

The objective of this proposal is to test the feasibility and acceptability of a lifestyle risk reduction intervention for patients with lung cancer receiving surgical treatment. This study will provide the preliminary data needed to conduct a larger randomized controlled trial that tests an innovative, multidisciplinary intervention that has the potential to transform the standard of care for patients receiving surgical treatment for lung cancer.


Eligibility Criteria:
Patient Inclusion Criteria:

* \> 21 years of age
* English speaking
* MD approval to participate in study
* Meets one of the inclusions below:
* 1. a histological diagnosis of NSCLC undergoing potentially curative treatment
* 2. OR those undergoing surgical procedures for lung cancer (includes patients undergoing diagnostic testing or those presenting with lung nodules
* 3.OR patients who have had a surgical procedure for lung cancer within the last six months.
* May invite a buddy to join study with them defined as a friend, partner, adult child or sibling

Buddy Inclusion Criteria:

* ≥ 21 years of age,
* English speaking, who is invited by the subject to join as a support person (e.g., friend, partner, adult child or sibling)
Tofogliflozin GLP-1 Analogue Combination Trial

An open-label, multicenter study to evaluate 52-week long-term safety, tolerability and efficacy of Tofogliflozin with GLP-1 analogue treatment in type 2 diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria:

* The subject aged from 20 to 75 years old with type 2 diabetes mellitus(T2DM)
* The subject with hemoglobin A1c ≧7.5% - \<10.5 %
* The subject who has been receiving a stable dose and regimen of GLP-1 analogue over 8 weeks before Screening test

Exclusion Criteria:

* The subject with type 1 diabetes mellitus
* The subject with Pregnancy or lactation
* The subject with Fasting Plasma Glucose ≧ 270 mg/dl
* The subject with history of metabolic acidosis, including diabetic ketoacidosis ,within 1 year prior to screening
* The subject with myocardial infarction, stroke, or heart failure requiring hospitalization or drug or alcohol abuse within the previous 6 months
* The subject with serum creatinine level greater than 2.0 mg/dL for men and 1.5 mg/dL for women
* The subject with aspartate aminotransferase(AST) or alanine aminotransferase(ALT) ≧ 2.5 times the upper limit of the reference range at the central laboratory test facility
* The subject has received treatment with another investigational product or non-approved drug 3 months before screening
* The subject with history of Tofogliflozin therapy
* The subject with estimated glomerular filtration rate of \<30 mL/min/1.73 m\^2
* The subject who frequently experiencing orthostatic hypotension
* The subject systolic blood pressure of ≧ 180 or mmHg of diastolic blood pressure of ≧ 100 mmHg
* The subject required a change in the dosing regiment for the following drugs within 4 weeks before screening : Lipid-lowering drug , Antihypertensive drug, Thyroid hormone drug , Uric acid lowering drug
Impact of Inflammation Biomarkers on the Acute Respiratory Distress Syndrome (ARDS) Definition

The ARDS has a clinical definition with criteria of the American-European Consensus Conference (1994). This definition inconveniently applies to a lot of patients with acute respiratory failure.

We know that there are 2 forms of ARDS morphology on CT scan : "lobar attenuation" (loss of aeration with no concomitant excess in lung tissue) predominating in the lower lobes and "non lobar attenuation" with diffuse and massive loss of aeration with excess lung tissue in all the pulmonary parenchyma.

Today, plasmatic biomarkers are used as prognostic and diagnostic markers of ARDS. Some of them are characteristics of the different damages in the ARDS (alveolar epithelium and vascular endothelium lesions) : sRAGE, SP-D, PAI 1 and sICAM 1.

This study's hypothesis is that patients with ARDS criteria and lobar morphology on CT scan present loss of aeration but no inflammatory pulmonary oedema, whereas patients with non lobar morphology on CT scan present both characteristics.

The primary purpose of our protocol is to show that the patients who respond to ARDS criteria and have a lobar morphology on CT scan do not have an elevation of the biomarkers specific to the pulmonary aggression of ARDS.

This multicentric prospective observational study will compare the level of different biomarkers specific to ARDS damages : the soluble form of the receptor for advanced glycation end products (sRAGE), the surfactant protein D (SP-D), Plasminogen Activator Inhibitor type 1 (PAI-1) and Soluble Intercellular Adhesion Molecule-1 (sICAM 1) in the two pulmonary morphologies of ARDS on CT scan : lobar and non lobar.

Patients under mechanical ventilation and with ARDS criteria for less than 24 hours(American-European Consensus Conference, 1994) will be enrolled.

Within 24 hours of enrolment, 10ml of blood sample will be collected and stored at -80°C. Plasmatic biomarker concentrations will be determined through ELISA method.

Within 48 hours of enrolment, patients will have a pulmonary CT scan without injection (end of expiration and ZEEP), a classical practice in this pathology.

Nine university hospitals will take part in this study.

Eligibility Criteria:
Inclusion Criteria:

* Patients \> 18 years
* Patients within the first 24 hours after onset of ARDS according to the 1994 American-European Consensus Conference (AECC)
* Patients under mechanical ventilation

Exclusion Criteria:

* Pregnancy
* Acute exacerbation of diabetes
* Dialysis for end-stage kidney disease
* Alzheimer's disease
* Amyloidosis
* Evolutive neoplastic lesion
* Chronic hepatic disease: type C hepatitis, non alcoholic cirrhosis and adenocarcinoma.
* Evolutive COPD
* Patients enrolled in another study
The Establishment of Total Joint Arthroplasty Registry Database

The purpose of this study will establish total joint arthroplasty registry database in Kaohsiung Chang Gung Memorial Hospital and collect patient-reported outcome.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing primary hip or knee arthroplasty
* Patients undergoing revision hip or knee arthroplasty
* Patients undergoing partial hip or knee arthroplasty

Exclusion Criteria:

* Incomplete patients' data
* Follow up less than 1 year after surgery
* Unwillingness to sign the informed consent
Bioavailability Study of Risperidone Orally Disintegrating Tablets 1 mg of Dr.Reddy's Laboratories Limited Under Fasting Conditions

The purpose of this study was to assess the single-dose relative bioavailability study of 1 mg risperidone orally disintegrating tablets and (Risperdal M-TAB) under fasting conditions.

Comparative, Randomized, Single-Dose, 2-way Crossover Bioavailability Study of Dr Reddy's Laboratories Ltd. and Janssen Pharmaceutica Products, LP. (Risperdal M-TAB) 1 mg Risperidone Orally Disintegrating Tablets in Healthy Adult Male Volunteers under Fasting Conditions

Eligibility Criteria:
Inclusion Criteria:

Subjects were included in the study only if they met all of the following criteria:

* Healthy non-smoking (for at least 3 months) adult male volunteers, 18-45 years of age;
* Weighing at least 60 kg for males and within 15% of their ideal weights (Table of "Desirable Weights of Adults", Metropolitan Life Insurance Company, 1983);
* Medically healthy subjects with clinically normal laboratory profiles and ECGs;
* Voluntarily consent to participate in the study.

Exclusion Criteria:

Subjects were excluded from the study if there was evidence of any of the following at screening or at any time during the study:

* 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 risperidone or benzodiazepines or other antipsychotic drugs;
* seizures;
* glaucoma or hypermetropia.
* Positive results on Human Immunodeficiency Virus (HIV), Hepatitis B Surface Antigen (HbsAg) and Hepatitis C Virus (HCV) Tests.
* Subjects whose sitting blood pressure is less than 110/60 mm Hg at screening or 100/55 mm Hg before dosing.
* Subjects whose pulse is lower than 55 b.p.m. at screening or 50 b.p.m. prior to dosing. Subjects whose PR interval is ≥ 190 msec at screening and prior to dosing.
* Subjects whose aTe interval is \> 450 msec at screening and prior to dosing.
* Subjects with a body temperature ≥38°C before dosing.
* Subjects who have used any drugs or substances known to be strong inhibitors of CYP enzymes (formerly known as cytochrome P450 enzymes) within 10 days prior to the first dose.
* Subjects who have used any drugs or substances known to be strong inducers of CYP enzymes (formerly known as cytochrome P450 enzymes) within 28 days prior to the first dose.
* Subjects who have been on a special diet (for whatever reason) during the 28 days prior to the first dose and throughout the study.
* Subjects who, through completion of the study, would have donated in excess of: 500 mL of blood in 14 days, or 1500 mL of blood in 180 days, 2500 mL of blood in 1 year.
* Subjects who have participated in another clinical trial within 28 days prior to the first dose.
The Effects of Internet-Based and Supervised Exercise Programs in People With Multiple Sclerosis

The main aim of this study is resarch and compare the effects of supervised exercise programs and internet-based exercise programs, which have started to benefit from their effects in recent years, known for not requiring conditions such as transportation distance, cost and time, on motor disorders and quality of life in people with multiple sclerosis (MS). This study conducting for develop a new perspective on conventional physiotherapy and rehabilitation practices. Our study will be performed in people with MS with a high EDSS score, is seen as an important contribution for the literature.

The groups were included in exercise programs of 16 sessions in total, twice a week for 8 weeks. Exercise programs will consist of warm-up, aerobic exercises, strengthening exercises, balance exercises, breathing exercises, cooling and relaxation exercises. Exercise programs will be created by the physiotherapist and arranged every 2 weeks according to the patients' conditions. Patients who do not participate in the program 2 times in a row will be excluded from the study.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with MS by a neurologist
* Being between ages of 18-65
* Not having had an attack in the last 3 months
* The score of Expanded Disability Status Scale (EDSS) is 5.5- 7.5
* Not participating in a another physiotherapy and rehabilitation program
* Having internet access

Exclusion Criteria:

* Pregnancy
* Severe cognitive impairment that effects participating to rehabilitation
* The cardiopulmonary disease that will prevent aerobic exercise
* Having a major hearing and/or vision problem
* Having a major speech disorder