cyrilzakka/clinical-trials huggingface dataset:
Zinc Supplementation In Very Low Birth Weight Infants-A Randomised Controlled Trial

* Zinc (Zn) is a structural component of human body and is a crucial element for a wide variety of cascades that take place in almost all organ systems.
* Due to many reasons, preterm infants are generally believed to be naturally in a negative Zn balance during the early periods of life.
* Regulation of intestinal Zn absorption of preterms is unrelated to infant's Zn status.
* There still is a lack of knowledge in the possible relation of Zn deficiency and development of NEC and/or feeding intolerance in preterm infants.
* Even if Zn is studied as an adjunct treatment for neonates and young infants with sepsis and found to reduce treatment failure in these high risk population, data in preventing infectious diseases in preterm infants is still lacking.

Background and Objectives: Preterm infants have high zinc (Zn) requirements and are generally believed to be in a negative Zn balance in the early period of life. In this study, we aimed to investigate the effect of high dose Zn supplementation in very low birth weight (VLBW) infants on feeding intolerance and development of mortality and/or morbidities including necrotizing enterocolitis (NEC), late-onset sepsis (LOS).

Methods: This is a prospective randomized trial. VLBW preterm infants with gestational age of \<32 weeks were randomly allocated on the seventh day of life to receive extra amount of supplemental zinc along with the enteral feedings or not, besides regular low dose supplementation, from enrollment until discharge. Outcome measures were feeding intolerance, NEC (stage≥2), LOS and mortality.

Eligibility Criteria:
Inclusion Criteria:

* \< 32 weeks gestational age and/or \<1500 gr birth weight
* Born in the study hospital
* Being able to be fed enterally, even in very small amounts, regardless of the volume of the nutrient

Exclusion Criteria:

* Major congenital malformations and/or critical congenital heart defects
* Born in another hospital
* Severe birth asphyxia
* Severe sepsis
* Previous early-onset NEC history
* Infants on the intervention arm who did not continue Zinc supplementation during the study period
* Hemodynamically unstability
* Infants nil per os
* No consent from the family
* Death before the 7th day of life
Associations of Lipid Measures With Premature Myocardial Infarction: a Cross-sectional Study

Acute myocardial infarction (AMI) is the first cardiovascular cause of death that seriously threatens human health worldwide. Its incidence rate and mortality are increasing year by year and becoming younger. According to statistics, the average age of men and women with AMI for the first time is 65.6 years old and 72 years old respectively, of which 4%\~10% AMI occurred before 45 years old. At present, there is no uniform age threshold for young AMI. Generally speaking, AMI with onset age less than 55 years for men and 65 years for women is called early-onset AMI, accounting for 5%\~13% of AMI. Compared with elderly patients with AMI, patients with early onset AMI have different risk factors, clinical characteristics and prognosis, such as lower proportion of patients with diabetes and hypertension, more single vessel lesions and rare left main artery involvement, and higher long-term recurrence rate and mortality. Although the progress of preventive measures and treatment methods has reduced the hospitalization rate of elderly AMI patients, the number of young AMI patients in hospital is still rising. Therefore, in-depth analysis of the characteristics of risk factors of early onset AMI and early intervention are of great significance to reduce the risk of onset and improve long-term prognosis.

Hyperlipidemia is an independent risk factor for coronary heart disease at all ages, and is more closely related to early onset AMI. It is reported that more than 50% of early onset AMI patients are accompanied by hyperlipidemia. However, at present, the research on the relationship between blood lipids and early onset AMI is limited to the comparison of the level of single lipid component between early onset AMI and different control groups, or the comparative analysis of the relationship between a specific lipid component and the risk of early onset AMI with young healthy people. There is no research to compare the correlation between various lipid components and the risk of early onset AMI. Therefore, this study plans to deeply analyze the correlation between different blood lipid components and their ratios and early onset AMI, and further analyze which blood lipid indicators are most closely related to early onset AMI through large sample clinical research data, taking late onset AMI patients as the control, which should be paid early attention to and strictly managed.


Eligibility Criteria:
Inclusion Criteria:

* According to the fourth Universal Definition of Myocardial Infarction (2018), the clinical diagnosis was acute myocardial infarction (AMI), including type 1, 2, 3, 4b and 4c.
* Complete coronary angiography
* Complete biochemical and blood lipid tests

Exclusion Criteria:

* Recurrent AMI
* The onset of AMI exceeds 7 days
* Continuous taking of lipid-lowering drugs ≥ 5 days
* Patients with missing data
Therapeutic Effect of Desogestrel on Ventilatory Control in Patients With Congenital Central Hypoventilation Syndrome

Background: Congenital Central Hypoventilation Syndrome (CCHS) is a rare disorder of automatic control of breathing. This disease can manifest as early as birth. Patients with this disease have a fundamental lack of central drive breathing. They do not mount any responses to hypoxia or hypercapnia during sleep or wakefulness. This places them at risk of injury or death whenever they are not consciously breathing. They require lifelong assisted ventilation while sleeping, and some while awake. Progesterone is a known respiratory stimulant in normal individuals, and it has been shown in one study of 2 patients that this drug may improve CO2 responsiveness in patients with CCHS. However, this observation requires confirmation.

Hypothesis: Exogenous progesterone (in oral contraception pills) will improve CO2 responsivity by hyperoxic hypercapnic ventilatory response testing, hypoxic responsivity using 5-breath nitrogen breathing, hyperoxic ventilatory response while breathing 100% oxygen, and improve spontaneous ventilation during sleep in CCHS females \>15-years of age. The progesterone will also depress ventilatory response using a hyperoxia test.

Study Methodology: Baseline measures of CO2 and oxygen responsivity, and spontaneous ventilation during sleep, will be performed at baseline and after 3-weeks of taking a progesterone containing oral contraceptive agent. CO2 responsivity will be measured using a hyperoxic hypercapnic ventilatory response test. Hypoxic responsivity will be measured using a 5-breath 100% nitrogen breathing test. Hyperoxic responsivity will be measured by having subjects breathe 100% oxygen for 2-minutes. Subjects will perform an overnight polysomnogram to assess adequacy of gas exchange during spontaneous breathing while asleep. A progesterone containing oral contraception pill will then be given for 3-weeks, and the above measures repeated. Serum progesterone will be measured at baseline and at the time of study.


Eligibility Criteria:
Inclusion Criteria:

* diagnosed congenital central hypoventilation syndrome (CCHS)
* female
* greater than or equal to 16 years of age

Exclusion Criteria:

* less than 16 years of age
* male
* pregnant
* poor adherence to medications
* inability to perform pulmonary maneuvers for tests
* contraindications to oral contraceptives
* pulmonary hypertension
Analysis of Next Generation PET and Liquid Biopsy to Monitor mCRPC Treated With Abiraterone: ANGELA Trial

By incorporating dual-tracer PET/CT (PSMA and FDG) and ctDNA, we aimed to evaluate lesion heterogeneity and genomic change of mCRPC patients receiving novel hormonal therapy. The relationship between treatment response and different molecular characterization, as well as imaging features would also be evaluated.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed as mCRPC according to EAU-ESTRO-SIOG 2016 and PSA \> 10ng/ml;
2. No previous treatment with novel hormonal therapy;
3. ECOG 0-2;
4. Normal organ function, WBC \>= 3000/mm3 or Neutrophil \>= 1500/mm3;
5. Aged 18 to 85 years old when issuing written informed consent;
6. Life expectancy \> 12 months.
7. Consent and able to carry out follow-up visit and cooperate with all other study procedures.

Exclusion Criteria:

1. Severe disease or other medical conditions suggesting a high risk of death within 1 year, which may interfere with follow-up. Decided by investigator;
2. Diagnosed with any other malignant tumor within 3 years before enrollment;
3. Unable to provide necessary follow-up information;
4. Other conditions that are judged as ineligible by the investigator.
Effects of AZD5004 in Adults Who Are Living With Obesity or Overweight With at Least 1 Weight-related Comorbidity

A Phase IIb, global, randomized, parallel-group, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of AZD5004 compared with placebo, given once daily as an oral tablet(s) for 36 weeks, in male and female participants at least 18 years of age who are living with obesity (body mass index \[BMI\] ≥ 30 kg/m2), or overweight (BMI ≥ 27 kg/m2) who have at least 1 weight-related comorbidity

This is a Phase IIb, global, randomized, parallel-group, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of 5 doses of AZD5004 compared with placebo, given once daily as an oral tablet or tablets for a duration of 36 weeks, in adults aged 18 years and above, who are living with obesity (BMI ≥ 30 kg/m2), or overweight (BMI ≥ 27 kg/m2) and have at least 1 weight-related comorbidity (Hypertension, Dyslipidemia or hyperlipidemia, CV disease and/or Obstructive sleep apnea). Approximately 304 participants will be randomized in the study. The dual primary endpoints are percent change in body weight from baseline at 26 weeks and the proportion of participants with weight loss ≥ 5% of baseline weight at 26 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Adults ≥ 18 years of age.
* BMI of (a) ≥ 30 kg/m2, or (b) ≥ 27 kg/m2 and have a current diagnosis of at least 1 of the following weight-related comorbidities (treated or untreated):

  (i) Hypertension (ii) Dyslipidemia or hyperlipidemia (iii) CV disease (iv) Obstructive sleep apnea
* A stable body weight for 3 months prior to Screening (± 5% body weight change).

Exclusion Criteria:

* Have obesity induced by other endocrine disorders, such as Cushing's syndrome or monogenic or syndromic obesity such as Prader-Willi syndrome.
* Has received prescription or non-prescription medication for weight loss within the last 3 months prior to Screening.
* Previous or planned (within study period) bariatric surgery or fitting of a weight loss device (eg, gastric balloon or duodenal barrier).
* History of type 1 diabetes mellitus or type 2 diabetes mellitus.
* Clinically significant inflammatory bowel disease, gastroparesis, severe disease, or surgery affecting the upper GI tract.
* History of acute or chronic pancreatitis.
Transfer of Subjects From Subutex/Suboxone to RBP-6300

This study is designed to determine if opioid dependent subjects who are already receiving Subutex and/or Suboxone can transfer to RBP-6300. Upon completing the study, subjects will continue their pre-study prescribed dosage of Subutex and/or Suboxone

During the open-label Run-In Period (study days -7 to -1), participants receive Subutex®/Suboxone® at one of three dose levels, depending on the dose level for that subject on entry to the study: 8 mg/day, 16 mg/day, or 24 mg/day.

During the 7-day, active drug-controlled, double-blind Transfer Period (study days 1-7), participants are randomized to either Subutex®/Suboxone® or RBP-6300 active drug at dosing levels equivalent to the level during the Run-In Period plus placebo matching the other drug.

This is followed by a 3-day single-blind Subutex®/Suboxone® Transition Period in which participants receive the same dose given during the Run-In Period.

Eligibility Criteria:
Inclusion Criteria:

* Be Male or non-pregnant, non-lactating females
* Be at least 18 years of age
* Meet Diagnostic and Statistical Manual of Mental Disorders, DSM-IV-TR (Diagnostic and Statistical Manual-IV-TEXT REVISION)criteria for opioid dependence at screening
* Be on stable dose of 8, 16, or 24mg/day for about 30 days prior to screening
* Female subjects of childbearing potential must have a negative urine test prior to enrollment into the study

Exclusion Criteria:

* Have participated in an experimental drug or device study within the last 60 days
* If female, be breast feeding or lactating
* Have any medical condition that in the opinion of the physician investigator would preclude the subject from completing the study
* Have a clinically significant abnormal finding (in the opinion of the investigator)
Evaluating the Effectiveness and Outcomes of Silicone Breast Prosthetics

This trial will evaluate the outcome of placement of silicone breast prosthetics.

Patients will be evaluated for complications following placement of silicone breast prostheses.

Eligibility Criteria:
Inclusion Criteria:

* over 18 undergoing breast reconstruction

Exclusion Criteria:

* patients with collagen vascular diseases, rheumatoid arthritis, scleroderma, etc.

Study Closed
Simple Psychological Interventions and Cryoanalgesia

This study aims to explore the effect of using simple psychological interventions and cryoanalgesia for reducing arterial punctures pain and anxiety in critically ill patients

The present study will be carried out in two interventions Patients who received cryoanalgesia: patients subjects underwent arterial puncture. patients in the intervention group had a small plastic bag filled with 12 oz of crushed ice applied to the radial artery puncture site for 3 min (timed with a stopwatch) without external compression or massage.

Psychological interventions using verbal signals of the impending procedure, music distraction, visual distraction, and breathing interventions be used during arterial puncture in adults

Eligibility Criteria:
Inclusion Criteria:

* Adult patients of both genders.
* Consciousness patient required arterial puncture

Exclusion Criteria:

* Unconsciousness patients Patients with complicated site from arterial puncture
Definite Stent Thrombosis in Comatose Out of Hospital Cardiac Arrest Survivors

Reliable data on stent thrombosis (ST) in comatose out of hospital cardiac arrest (OHCA) survivors is lacking. In comatose OHCA survivors suspicion of ST can be made with precise clinical monitoring of the patient with definite confirmation being possible only by coronary angiography or autopsy of deceased patients. However in addition to definite ST which can be confirmed using current protocols, additional ST which are clinically silent are plausible. These could be identified only by systematic coronary angiography of all OHCA survivors or by autopsy of deceased patients. Collectively with definite ST confirmed by coronary angiography upon clinical suspicion the incidence of all forms of ST in survivors of OHCA treated with PCI and hypothermia could be obtained.

Consecutive comatose survivors of OHCA treated with percutaneous coronary intervention (PCI) and hypothermia will be included. All study participants will receive treatment per our established clinical protocol and will be followed for 10 days. In all patients in whom clinical suspicion of ST will be made immediate coronary angiography and if necessary PCI will be carried out. In all patients that will die in the observed period of 10 days autopsy will be performed. Survivors however will have an additional control coronary angiography on 10th day after admission, to assess presence of clinically silent ST.

We expect that the incidence of true definitive ST in comatose OHCA survivors treated with urgent PCI with stenting and hypothermia is greater than one, which is confirmed on the basis of clinical suspicion by angiography or later with autopsy.


Eligibility Criteria:
Inclusion Criteria:

* Comatose out-of-hospital cardiac arrest survivors admitted to University Medical Centre Ljubljana
* Treated with primary PCI with stenting
* Treated with therapeutic hypothermia.

Exclusion Criteria:

* Younger than 18 years old.
A Study of DPK-060 to Investigate Clinical Safety and Efficacy in Patients With Acute External Otitis

The primary objective of this study is to evaluate safety and tolerability of DPK-060 2% ear drops compared to placebo for DPK-060 ear drops in patients with acute external otitis. The secondary objectives are to evaluate clinical cure and microbiological growth following treatment with DPK-060 2% ear drops compared to placebo for DPK-060 ear drops.


Eligibility Criteria:
Inclusion Criteria:

* A clinical diagnosis of acute external otitis of a severity degree not requiring specialist care
* Age 12 years and older

Exclusion Criteria:

* Known or suspected perforation of the tympanic membrane
* A clinical diagnosis of chronic suppurative otitis media, acute otitis media, acute otorrhea or malignant otitis externa
* Local ear canal abnormalities
* Congenital abnormalities of the external auditory canal or obstructive bony exostosis
* Mastoiditis or suppurative non-infectious ear disorders (e.g. cholesteatoma)
* Malignant tumour of the external auditory canal
* History of otologic surgery (except for surgery confined to the temporomandibular joint)
* Seborrheic dermatitis or other dermatological conditions of the external auditory canal that would complicate evaluation
* Current or prior use (within 7 days) of ear washes using alcohol, vinegar or other astringents
* Any clinically relevant past or present infectious/viral disease
* Current infection requiring systemic antimicrobial therapy
* Current or prior use of systemic (within 14 days) or topical (within 7 days) antibiotics
* Current or prior use of systemic (within 30 days) or topical (within 7 days) steroids
* History of immune dysfunction/deficiency and immunosuppressive therapy
* Diabetes mellitus
Dentine Hypersensitivity Management KAP Study

The study aims to assess and compare the knowledge, attitudes, and practices of Egyptian and Nigerian dentists on etiology, diagnosis, and management of DH. Also to identify if level of education, culture and environment have influence in the diagnosis and management of DH.

Diagnosis of dentin hypersensitivity is a challenge faced by dentists with different educational levels and the condition might be overlooked and not properly managed leading to persistent pain and poor quality of life for patients. Till the now, literature lacks rigorous guidelines for systematic diagnosis, prevention, categorization of severity and management of dentin hypersensitivity.

This study intends to spot the light on the current approaches adopted by dentists in Egypt and Nigeria towards diagnosis and management of Dentine Hypersensitivity. It also intends to compare the findings and identify the influence of geographic location, different educational levels, and degree of dental education in the management of Dentine Hypersensitivity

Eligibility Criteria:
Inclusion Criteria:

* Must be a Dentist
* Must be in clinical practice
* Must be practicing in Egypt or Nigeria
* Willingly CHOOSE to participate in the study

Exclusion Criteria:

* Dentists that choose NOT to participate in the study
Clinical Study of Antiviral Therapy Combined With Novel Immunotherapy for CHB in Adults

Establish a study cohort of adult chronic hepatitis B antiviral treatment based on the principle of responseguidedtreatment (RGT) corresponding to the child cohort, analyze the clinical cure factors of IC and IT stage adults chronic hepatitis B, and optimize the antiviral treatment plan. To determine the safety and efficacy of PD-1 antibody combined with Peg-FNa-2b in the treatment of adult NAs patients with CHB advantage.

This research group established an adult randomized controlled study cohort corresponding to the children cohort: 1 immunetolerance (IT) and 1 immuneclearance (IC) antiviral treatment cohort, respectively according to 1: 1 Randomly divided into two intervention groups: nucleoside (acid) analogues (NAs) and NAs combined with pegylated interferon α-2b (PegIFNα-2b). 1 NAs treatment-advantaged population antiviral combined with novel immunotherapy cohort: PD-1 antibody, PegIFNα-2b and combination group were randomly enrolled 1:1:1, and the response guidance treatment plan was adjusted according to the response of patients during treatment, the HBsAg clearance rate at 24 weeks and 48 weeks of different optimal treatment groups was evaluated, the clinical curative characteristics and differences between children and adults were compared, and the key factors affecting clinical cure were screened. To determine the safety and efficacy of PD-1 antibody combined with Peg-FNa-2b in the treatment of adult NAs patients with CHB advantage.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years old；
* Meet the 2022 Chronic Hepatitis B Guidelines definition of chronic HBV infection: HBsAg and/or HBVDNA positive \>6 months;；
* Immune clearance period: HBeAg positive, HBVDNA positive, ALT\>40U/L;
* Newly treated patients;
* Willing to sign informed consent

Exclusion Criteria:

* Patients with HAV, HCV, HEV infection and autoimmune liver disease; Pregnant and lactating women and patients who plan to give birth in the near future;
* Patients with cirrhosis or liver cancer indicated by imaging or liver hardness testing;
* A history of serious heart disease, including unstable or uncontrolled heart disease within the last 6 months;
* Have a mental illness or history of mental illness;
* Have uncontrolled seizures;
* Alcoholics or drug users who have not abstained;
* Have uncontrolled diabetes, hypertension, thyroid disease, retinopathy, autoimmune disease, etc.
Establishing Safe Drainage Limits for Pleural Chest Tube Removal.

The purpose of the study is to evaluate a safe threshold for when to remove chest tubes in patients based on the amount of drainage present.

Measurement of pleural fluid drainage in chest tubes of trauma patients.

Eligibility Criteria:
Inclusion Criteria:

* Presence of at least one chest tube
* No air leak present
* Fluid is not infected
* Pleural drainage of fluid was an indication for placement of the chest tube
* Patient is post-thoracic surgery
* Patient is post-thoracic trauma
* Informed consent obtained

Exclusion Criteria:

* Presence of air leak
* Infected pleural fluid
* Active intra-thoracic bleeding
* Thoracic empyema
* Non-removal of chest tube (i.e.: expired)
* Pregnancy
* Less than 18 years of age
* Unable to obtain informed consent