cyrilzakka/clinical-trials huggingface dataset:
Periodontal Regeneration Using Vitamin A and PRF Compared to PRF Alone Treating Intra-bony Defects

Will the addition of vitamin A (Retinol) to PRF add more periodontal regenerative value in the treatment of intra-bony defects compared to PRF alone, clinically?

Vitamin A has been extensively studied for its role in bone health. Vitamin A can be consumed in two forms, i.e., preformed retinol and pro-vitamin A. Preformed retinol is often found in food originated from animals, such as dairy, liver and eggs. Provitamin A, such as alpha (α)-carotene, beta (β)-carotene orβ-cryptoxanthin, are commonly found in plant-based food, such as fruits and vegetables (Toti et al., 2018). At certain concentrations, it has been proven to enhance the pluripotency of periodontal cells for regeneration (Fawzy El-Sayed, Hein and Dörfer, 2019).

Yet, to the best of our knowledge no clinical trials have evaluated the effect of Vitamin A added to PRF in the regeneration of intra-bony defects. This study is to fill the gap of knowledge.

Eligibility Criteria:
Inclusion Criteria:

* Stage III periodontitis patient (Papapanou et al., 2018) with 3 walled or 2 walled intra-bony defects.
* Non-smokers
* No pregnancy
* Medically free
* Presence of intra-bony defect of three or two walls (as predominant component) with a radiographic intra-bony component of ≥3 mm;
* Presence of ≥2 mm of keratinized gingiva at the tooth with the defect.
* Willingness to optimal compliance with the study procedures

Exclusion Criteria:

* Uncontrolled systemic or local infection in the tissue of interest,
* History or clinical evidence or positive tests for Human Immunodeficiency Virus (HIV), Hepatitis B virus (HBV), Hepatitis C virus (HCV).
* History of chronic autoimmune disease
* Participation in an intervention trial in the same quadrant in the previous two months.
* Type III tooth mobility, vertical root fracture in the selected tooth.
* Contraindications for periodontal surgery.
Comparison of Anti-Xa Activity of ENOXA ® Versus LOVENOX ® in Acute Coronary Syndrome

This study is a clinical trial monocentric, open, randomized ENOXA ® versus LOVENOX ®, conducted on two parallel groups of patients admitted in emergency for acute coronary syndrome.

The patients included in this study with an acute coronary Syndrome be admitted to the emergency room and receive treatment with enoxaparin. Low molecular weight heparin (LMWH) treatment in this indication is usually spread over a week. The experience of the study intends to focus only on the first injection administered in selected patients.

Two assays are carried out, including an assessment of the anti-Xa activity initially before injection of enoxaparin, and 4 hours after administration of the first syringe.

Clinical monitoring is intrahospital from the date of hospitalization of patients included until emergency exit (transfer to another service, or return home)

Tolerance assessment (clinical and biological) is performed during follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Male or female over the age of 20 years
* acute coronary syndrome
* Admission to the emergency department

Exclusion Criteria:

* Patient participating in another study
* Pregnant or lactating or of childbearing potential not using medically accepted method of contraception
* Taking an anticoagulant in the last three months
* Patient with known haemostatic disorder
* Contraindication absolute and / or relative to the use of enoxaparin
* Nobody wishing to participate in this study or not having the ability to understand its objectives
Comparing Symbicort® As-Needed or Bricanyl As-Needed or Pulmicort® Once Daily + Bricanyl As-Needed in Asthma Patients

1. The primary objective of this study is:

   * To evaluate the magnitude of the protective effect of the combination of budesonide and formoterol on an as-needed basis compared to the use of terbutaline as-needed on exercise induced bronchoconstriction in adults and adolescents with mild intermittent asthma
2. The secondary objectives of this study are:

   * To evaluate the magnitude of the protective effect of the combination of budesonide and formoterol as-needed compared to regular once daily use of budesonide plus terbutaline as-needed on exercise induced bronchoconstriction in adults and adolescents with mild intermittent asthma
   * To evaluate safety of budesonide/formoterol as-needed, terbutaline as-needed and regular use of budesonide + terbutaline as-needed as terms of adverse event


Eligibility Criteria:
Inclusion Criteria:

* History of exercise induced asthma
* Maximum 4 asthmatic episodes per week requiring use of reliever medication

Exclusion Criteria:

* No previous treatment with inhaled oral corticosteroids during the last month before randomisation
* Suspected poor capability to follow instructions, ie to exercise 3-4 times a week
ZD 1839 in Treating Patients With Metastatic or Recurrent Cancer of the Head and Neck

RATIONALE: Biological therapies such as ZD 1839 may interfere with the growth of tumor cells and slow the growth of head and neck cancer.

PURPOSE: Phase II trial to study the effectiveness of ZD1839 in treating patients who have metastatic or recurrent cancer of the head and neck.

OBJECTIVES: I. Determine the activity of ZD 1839 in patients with metastatic or recurrent squamous cell carcinoma of the head and neck. II. Determine the effectiveness of this regimen in these patients. III. Determine the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study. Patients receive oral ZD 1839 once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 22-46 patients will be accrued for this study within 1-2 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed metastatic or recurrent squamous cell carcinoma of the head and neck that is incurable by surgery or radiotherapy At least 1 lesion measurable in at least 1 dimension At least 20 mm by conventional techniques OR At least 10 mm by CT scan No known brain metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Karnofsky 60-100% Life expectancy: More than 3 months Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin normal AST/ALT no greater than 2.5 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No history of allergic reactions to compounds of similar chemical or biological composition to ZD 1839 No active infection No other uncontrolled illness No psychiatric illness or social situation that would preclude study

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior epidermal growth factor receptor-based therapy for recurrent disease Chemotherapy: No more than 1 prior adjuvant or neoadjuvant chemotherapy and/or chemoradiotherapy regimen At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics See Chemotherapy At least 4 weeks since prior radiotherapy and recovered Surgery: See Disease Characteristics Other: No more than 1 prior regimen for recurrent disease No other concurrent investigational agents No concurrent combination antiretroviral therapy for HIV
Safety of Inhaled Preprandial Human Insulin in Subjects With Diabetes and Asthma

This trial is conducted in Europe, Asia, Oceania and the United States of America (USA).

This is a one-year clinical trial to compare the safety of inhaled preprandial human insulin to subcutaneous insulin aspart in subjects with type 1 or 2 diabetes and asthma.

The decision to discontinue the development of AERx® is not due to any safety concerns. An analysis concluded that fast-acting inhaled insulin in the form it is known today, is unlikely to offer significant clinical or convenience benefits over injections of modern insulin with pen devices.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 or type 2 diabetes
* Treatment with insulin and/or oral anti-diabetic drugs
* Asthma for at least 6 months
* Positive airway reversibility/bronchoprovocation test or documented positive test in the last 3 years
* HbA1C less than or equal to 11.0 %
* Body Mass Index (BMI) less than or equal to 40.0 kg/m2

Exclusion Criteria:

* Current smoking or smoking within the last 6 months
* Other current acute or chronic pulmonary disease excluding asthma
* Recurrent severe hypoglycaemia
* Proliferative retinopathy or maculopathy
Central Venous Catheter Lock Solution

The purpose of this study is to determine whether the application of 47% citrate lock solution decreases the incidence of infection and thrombosis of central venous catheter in hemodialysis population.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of end stage renal disease

Exclusion Criteria:

* Patients refusing randomization
HFOV With Intermittent Sigh Breaths in Neonate: Carbon Dioxide Level

The goal of this clinical trial is to the short-term effects of sigh breaths during High-frequency oscillatory ventilation (HFOV) in neonate undergoing mechanical ventilation. From meta-analysis, It revealed HFOV in neonates could reduce chronic lung disease or death rather than conventional ventilation.

The main question it aims to answer is: Do sigh breaths augment restoring lung volume and ventilation (CO2 level) in intubated neonate with HFOV? Participants will be applied sigh breaths (HFOV-sigh) during on HFOV. Researchers will compare HFOV-sigh mode to see if CO2 level (before-after intervention).

Sample size calculation (before and after intervention: two dependent mean)

* alpha = 0.05, beta = 0.2,
* Delta = 1.9, SD. = 4.35
* Calculated sample size = 42
* increase sample size if loss follow up 20%
* Final sample size (n) = 50

Subgroup analysis for

* preterm neonates
* very preterm or very low birth weight neonates
* extremely preterm or extremely low birth weight neonates

Eligibility Criteria:
Inclusion Criteria:

* Preterm and term neonate (gestational age 24-41 weeks) with postnatal age less than 28 days
* Already ventilated with high frequency ventilation at least 1 hours
* An umbilical or peripheral arterial catheterization was available

Exclusion Criteria:

* Previous or current pulmonary air leaks (pulmonary interstitial emphysema, pneumothorax, pneumomediastinum, and pneumopericardium)
* Heterogeneous lung disease including MAS, congenital diaphragmatic hernia
* Suspected lung hypoplasia
* Suspected or confirmed intraventricular hemorrhage grade III-IV
* Suspected or confirmed hypoxic ischemic encephalopathy or 5-min Apgar score less than 3
* Hemodynamic instability despite using inotrope(s)
* Arterial pCO2 level less than 45 mm Hg or more than 70 mm Hg before intervention
* Need a new arterial puncture for samples both before and after interventions
* Moribund status
* Parents' decision not to participate
Outcomes of Elective Cancer Surgery During the COVID-19 Pandemic Crisis

CovidSurg-Cancer is an international, multicentre, observational cohort study designed to evaluate the 30-day COVID-19 infection rates in elective cancer surgery during the COVID-19 pandemic.

Centres can elect to include one or more cancer types in the study, in any combination, depending on local expertise and capacity. During the pilot study, investigators should enrol patients with confirmed diagnoses of:

* Colorectal cancer
* Oesophagogastric cancer

As a rapid response study to the COVID-19 pandemic, included cancer types will evolve throughout the course of the CovidSurg-Cancer study period, for example, to include breast, liver, pancreatic, gynaecological, urological cancers, or sarcomas.

The rapid emergence of the COVID-19 virus has led to a global impact on elective surgical care.

We have very little evidence to guide us. The magnitude and effects of these changes are uncertain. The safety of operating on patients electively with the risks of COVID-19 postoperative pneumonia is unknown.

High-quality data will allow policy planning at regional and hospital level for both this outbreak and future pandemics. CovidSurg-Cancer will run in parallel to CovidSurg (which is capturing outcomes of patients undergoing surgery for all indications with concurrent COVID-19).

The primary aim is to evaluate the 30-day COVID-19 infection rates in elective cancer surgery during the COVID-19 pandemic.

Secondary aims include; comparison of the 30-day postoperative mortality rate in cancer surgery patients that develop COVID-19 infection versus those who do not; an exploration of the scale of resource constraints related to the COVID-19 pandemic, and their impact on outcomes of elective cancer surgery; to explore variation in the selection of patients for continuing elective cancer surgery during the COVID-19 pandemic; to evaluate the impact of the COVID-19 pandemic on treatment pathways for cancers with a decision for surgical resection with curative intent.

This investigator-led, non-commercial, non-interventional study is extremely low to zero risk. This study does not collect any patient identifiable information and data will not be analysed at hospital-level.

Eligibility Criteria:
Centre Inclusion Criteria:

- Any centre performing elective cancer surgery

Inclusion Criteria (patient):

* Adults (age ≥18 years) with a confirmed diagnosis of an included cancer type
* Decision made for surgical management with a curative intent

Exclusion Criteria:

* Surgery planned with non-curative intent
* Planned neoadjuvant therapy without a firm date for surgery, or awaiting restaging
Chronic and Acute Effects of Resistance Exercise on Older Subjects' Blood Pressure

The study aimed to evaluate the chronic and acute effects of high-intensity resistance training on blood pressure and its hemodynamic and neural determinators in healthy normotensive older subjects.

To investigate the chronic and acute effects of resistance training on blood pressure and its hemodynamic and neural determinators in elderly, 24 healthy normotensive older subjects were randomly divided into 2 groups: trained and control. The trained group was submitted a progressive high-intensity resistance training. Before and after 16 weeks, as well as, before and after the one training session, blood pressure (clinic and ambulatory), cardiac output (CO2 rebreathing), and autonomic modulation (spectral analysis of heart rate and blood pressure variabilities) were measured

Eligibility Criteria:
Inclusion Criteria:

* Age 60 to 80 years
* Normotensives
* Nonactive

Exclusion Criteria:

* Cardiovascular disease
* Cardiovascular medication
* Orthopedic problems
Single-ascending Dose Study With a Food-Effect Cohort to Evaluate AMG 581

The purpose of this study is to find out the time it takes to absorb, distribute, breakdown and remove the drug from the body, safety and tolerability of AMG 581 in healthy participants and subjects with schizophrenia.

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetic profile of single-ascending oral doses of AMG 581 in healthy subjects and subjects diagnosed with schizophrenia or schizoaffective disorder receiving antipsychotic treatment.

This will be a placebo-controlled, single-ascending oral-dose study of AMG 581 with a food-effect cohort. Approximately 70 subjects will be enrolled. This study will enroll healthy subjects into 8 cohorts (Cohorts 1,2,3,4,5,6,8 and 9), and subjects with schizophrenia or schizoaffective disorder receiving antipsychotic medication into a single cohort (Cohort 7).

Eligibility Criteria:
Inclusion Criteria:

* Provide informed consent prior to initiation of any study-related procedure
* Male and female subjects ≥ 18 to ≤ 45 years of age at the time of screening
* Non-nicotine or non-tobacco for healthy subjects
* No history of relevant medical disorders
* BMI ≥ 18.0 and ≤ 30.0
* Non-reproductive females
* Males practicing effect birth control
* Avoid tanning/direct sunlight
* Willing to consume high-fat meal
* Schizophrenia or schizoaffective disorder
* PANSS score ≤ 4 points on a few items (i.e. conceptual disorganization, hallucinatory behavior, excitement, suspiciousness/persecution, hostility, depression, anxiety, disorientation, uncooperativeness, disturbance of volition, and poor impulse control) / total score ≤ 80 points

Exclusion Criteria:

* Females lactating/breastfeeding
* Pregnant partners of male subjects
* Tremor or gait disturbance
* History of hereditary shorten QT syndrome
* Malignancy or tumor (other than skin cancers)
* History of GI disease
* QTc ≥ 450 msec or ≤ 380 msec
* Creatinine clearance \< 80 mL/min at screening
Effects of Selective Inhibition of Cholesterol Absorption With Ezetimibe on Intestinal Cholesterol Homeostasis in Dyslipidemic Men With Insulin-resistance - a Pilot Study

Ezetimibe has been shown to inhibit cholesterol absorption and several lines of evidence from in vitro systems and animal models suggest that this effect is associated with an increase in low-density lipoprotein (LDL) receptor expression in the small intestine. The impact of a treatment with ezetimibe on intestinal gene expression and protein mass levels of LDL receptor and other key genes involved in intestinal cholesterol homeostasis will be examined in dyslipidemic men with insulin-resistance. In the present study, gene expression studies and protein mass levels will be assessed on duodenal biopsies by real-time polymerase chain reaction (rt-PCR) and liquid chromatography-mass spectrometry (LC-MS/MS), respectively. The primary objective of this proposal is to examine the effects of ezetimibe on intestinal gene expression (rt-PCR) and protein mass levels (LC-MS/MS) of LDL receptor in dyslipidemic men with insulin-resistance. The secondary objective is to examine the impact of ezetimibe treatment on intestinal gene expression and protein mass levels of sterol regulatory element-binding protein (SREBP)-2, Niemann-Pick C1-Like1 (NPC1L1), ATP binding cassette gene (ABCG)-5/8, proprotein convertase subtilisin/kexin type 9 (PCSK9) and 3-hydroxy-3-methyl-glutaryl-CoA (HMG CoA) reductase.

Primary hypothesis Treatment with ezetimibe 10 mg/day will significantly increase duodenal mRNA and protein mass levels of LDL receptor in dyslipidemic men with insulin-resistance.

Secondary hypothesis Treatment with ezetimibe 10 mg/day will significantly increase duodenal mRNA and protein mass levels of SREBP-2, NPC1L1, ABCG5/8, PCSK9 and HMG CoA reductase in dyslipidemic men with insulin-resistance.


Eligibility Criteria:
Inclusion Criteria:

* Men aged between 18-60 years
* Waist circumference \> 102 cm
* HDL-cholesterol \< 1.1 mmol/L
* Triglycerides \> 1.7 mmol/L
* Fasting blood glucose \> 6.1 mmol/L
* Normal blood pressure (\<130/85)

Exclusion Criteria:

* Women
* Men \< 18 or \> 60 years
* Smokers (\> 1 cigarette/day)
* Body weight variation \> 10% during the last 6 months prior to the study baseline
* Subjects with a previous history of cardiovascular disease
* Subjects with type 2 diabetes
* Subjects with a monogenic dyslipidemia
* Subjects on hypertension medications or medications known to affect lipoprotein metabolism or the integrity of gastrointestinal mucosa
* Subjects with endocrine or gastrointestinal disorders
* History of alcohol or drug abuse within the past 2 years
* Subjects who are in a situation or have any condition that, in the opinion of the investigator, may interfere with optimal participation in the study.
An Observational Study On Metabolic Syndrome Parameters In Schizophrenia Patients Treated With Atypical Antipsychotics

The purpose of the study is to find and follow-up the metabolic syndrome parameters on patients administering atypical antipsychotics.

Sampling Method Details: Group of patients using the same atypical anti-psychotic.

Eligibility Criteria:
Inclusion Criteria:

* Female and male patients diagnosed as schizophrenia by the Diagnostic and Statistical Manual of Mental Disorders.
* Age between 18-45 years
* Patients who started atypical antipsychotic drug treatment or patients who switched from the previous conventional or atypical antipsychotic treatment to another atypical antipsychotic drug treatment by the decision of their physicians.

Exclusion Criteria:

* Patients who are pregnant or considering pregnancy.
Single and Repeated Dosing Study to Assess the Safety and the Concentration-time Profile of SAR228810 in Alzheimer's Patients

Primary Objective:

- To assess the safety and tolerability of escalating single and multiple doses of SAR228810 in patients with Alzheimer's disease (AD)

Secondary Objective:

- To evaluate the pharmacokinetic properties of SAR228810 after escalating single and multiple doses of SAR228810 in AD patients

14.5 to 22 months

Eligibility Criteria:
Inclusion criteria:

* Male or female patients with mild to moderate Alzheimer's disease, aged between 50 and 85 years inclusive
* Meets criteria for probable Alzheimer's of the National Institute of Neurologic and Communicative Disorders and Stroke - Alzheimer's Disease and Related Disorders Association
* Mini-mental state examination (MMSE)
* In reasonable and stable health state for Alzheimer's patients of this age and stage of disease as assessed by a comprehensive clinical assessment
* Magnetic resonance imaging consistent with Alzheimer's disease, not indicating any other cause for dementia symptoms than Alzheimer's disease
* Rosen Modified Hachinski Ischemic score
* If on symptomatic treatment for Alzheimer's disease (acetylcholinesterase inhibitors or/and memantine), must be stable in the last 30 days before screening

Exclusion criteria:

* Clinically significant neurological disease other than Alzheimer's disease
* Had a major psychiatric disorder
* Had a history of stroke, seizures, brain neoplasms, brain surgery, or any cerebrovascular disorder (including transient ischemic attack)
* History or presence of severe, uncontrolled and/or unstable angiopathy or vasculitis.
* History or presence of clinically relevant cardiac disease.
* Currently taking anticonvulsants, anti-Parkinsonians, antipsychotics, anticoagulants or narcotic drugs, recent immunosuppressive or cancer chemotherapy drugs, or cognitive enhancers. Concomitant therapies that are allowed if given at a stable dose for at least 30 days before screening are: acetylcholinesterase inhibitors and/or memantine; antidepressants of the class of selective serotonin reuptake inhibitors (no tricyclics); acetyl salicylic acid (ASA) at a dose ≤ 160 mg/day;

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.