cyrilzakka/clinical-trials huggingface dataset:
Duffy-null Associated Neutrphil Count (DANC) Pediatric Patients

There are currently no clinical and laboratory data that well characterize this neutropenia associated with the Duffy-null phenotype, particularly for pediatric subjects. In particular there are no data on the frequency of immune neutropenia in DANC neutropenic pediatric subjects.

The goal of this study is to :

* define the frequency of immune neutropenia within the cohort of DANC subjects under study
* evaluate the frequency of different degrees of neutropenia (mild-moderate-severe);
* evaluate the possible association between different degrees of neutropenia and the presence of infections.


Eligibility Criteria:
Inclusion Criteria:

* presence of Duffy-null phenotype

Exclusion Criteria:

* absence of Duffy-null phenotype
Efficacy and Safety of MEDITOXIN® in Cervical Dystonia

The purpose of this study is to test the hypothesis that the efficacy and safety of Meditoxin® are not inferior to Botox®'s in the treatment of Cervical Dystonia.

The allocated subject is injected Investigational Product(Meditoxin® or Botox®) 200\~300U in cervical muscles. The efficacy and safety are evaluated for 12weeks through 4 follow up visits.

Eligibility Criteria:
Inclusion Criteria:

* Men and women aged between 20 and 75.
* Patient who is diagnosed with primary cervical dystonia over 1 year.
* Patients whose total score is over 20 in TWSTRS and the severity score is over 10 in TWSTRS.
* For patients with prior treatments of Botox®, over 12 weeks have passed.
* Patients who voluntarily sign the informed consent
* Patients who can comply with the study procedures and visit schedule

Exclusion Criteria:

* Patient who has been diagnosed with pure anterocollis.
* Patient who has been diagnosed with neuromuscular disorder(myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, etc.)\\
* Severe respiratory function disorder or dysphasia
* Allergy in Investigational Product.
* Pregnant women, breast feeding women and patients disagreeing to use an acceptable contraception method
* Investigator's decision.
Opioid Free Anesthesia in Thoracic Surgery

Proper assessment of pain and adequate analgesia in thoracic surgery is a challenging issue for medical practitioners. Basic aspects of thoracic anaesthesia are general anesthesia, intubation with double lumen tube and separation of lung ventilation, however proper analgesia needs to be standardized. Role of opioids in this clinical setting is reduced due to high risk of respiratory system complications. Instead, use of opioid free anaesthesia and regional anaesthesia is proposed. The aim of this study is to compare the use of opioid anaesthesia with opioid free anaesthesia and paravertebral block.


Eligibility Criteria:
Inclusion Criteria:

* body mass index between 19-30 kg/m2,
* American Society of Anesthesiology (ASA) physical status between 1 and 3

Exclusion Criteria:

* lack of consent
* significant coagulopathy,
* contraindication to drugs used in protocol
* history of chronic pain,
* chest wall neoplastic invasion,
* previous thoracic spine surgery,
* mental state preventing from effective use of PCA device,
* renal failure (GFR \<60 ml/min/1,73 m2)
Automatic Control of Pressure Support Ventilation in Surgical Intensive Care Units

This bicentric, randomized, controlled trial examines the effectiveness of an automatic control of pressure support ventilation (SmartCare/PS) in critically ill patients.

During the weaning process vigilance, pulmonary mechanics and respiratory drive of the patient are changing. Consequently, ventilation settings have to be modified very often. The modifications can be conducted either according to a weaning protocol or automatically by an expert system (SmartCare/PS). This trial compares protocol-guided weaning with automatic weaning in post-surgical patients and examines the effect on total ventilation time, numbers of manipulations and alarms of the ventilator, length of stay in the ICU and in the hospital, 28- and 90-day mortality.

Eligibility Criteria:
Inclusion Criteria:

* Intubated or tracheotomised patients requiring mechanical ventilation at 9:00 am for longer than 9 hours (within this time period invasive and non-invasive ventilation is permitted)

Exclusion Criteria:

* Cerebral trauma / surgery
* Age \< 18 years
* Do-not-resuscitate-order
* Duration of mechanical ventilation \> 24 h
* Patient is currently participating in this trial (including 90 days follow-up period)
Safety, Tolerability and Pharmacodynamic Effects of Sublingual Immunotherapy (Tablets) With Recombinant Bet v1

To investigate the safety and tolerability of successive single rising doses of SLIT in subjects with allergic rhinitis and to investigate the safety and tolerability of multi high dose regimens of SLIT in subjects with allergic rhinitis.


Eligibility Criteria:
Inclusion Criteria:

* written consent
* Symptoms of birch pollen induced allergic rhinitis for at least the last 2 years.
* Sensitisation to birch pollen as demonstrated with a positive SPT to birch pollen and specific IgE level (birch pollen and r Bet v1) of at least Class 2 at screening.
* FEV1 at least of 80% of predicted values at screening.

Exclusion Criteria:

* Patient who previously received desensitization treatment to birch pollen and/or other betulaceae (e.g., hazel tree, alder...) or who plan to start desensitization treatment during this study.
Validation of the Diabetes Deep Neural Network Score for Diabetes Mellitus Screening

The Validation of the Diabetes Deep Neural Network Score (DNN score) for Screening for Type 2 Diabetes Mellitus (diabetes) is a single center, unblinded, observational study to clinically validating a previously developed remote digital biomarker, identified as the DNN score, to screen for diabetes. The previously developed DNN score provides a promising avenue to detect diabetes in these high-risk communities by leveraging photoplethysmography (PPG) technology on the commercial smartphone camera that is highly accessible. Our primary aim is to prospectively clinically validate the PPG DNN algorithm against the reference standards of glycated hemoglobin (HbA1c) for the presence of prevalent diabetes. Our vision is that this clinical trial may ultimately support an application to the Food and Drug Administration so that it can be incorporated into guideline-based screening.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years old
* Participants without a prior diagnosis of DM
* Participants with a recently measured HBA1c one month before enrollment or scheduled to undergo a HBA1c measurement within one month after enrollment
* Participants not scheduled for HBA1c and are willing to undergo a lab measured HBA1c
* Participants without risk factors for DM
* Participants with \> 1 of the following risk factors for DM:
* Age \> 40 years old
* Obesity (BMI \> 30)
* Family history: Any first degree relative with a hx of DM
* Lifestyle risk factors (exercise, smoking, and sleep duration)
* Ownership of a smart phone
* Able to provide informed consent
* Willingness to provide PPG waveforms

Exclusion Criteria:

* Participants with a history of DM
* Participants with a prior HBA1c \> 6.5%
* Inability to collect PPG signals (digit amputation, excessive tremors, etc)
* Lack of ownership of a smartphone
* Inability or unwillingness to consent and/or follow requirements of the study
Risk Factors and Diagnostic Performance of Predictors as a Screening Technique for Gestational Diabetes Mellitus

Background Gestational diabetes mellitus (GDM) is a condition that can have negative impacts on both mother and baby. Detecting GDM early is crucial, and fasting plasma glucose (FPG) has been suggested as a possible screening method. This retrospective cross-sectional study aims to investigate potential risk factors and complications associated with GDM. Additionally, it aims to establish the diagnostic performance of predictive factors as a screening method for GDM.

Methods Data were collected from the medical records of 247 pregnant women who visited high-risk pregnancy outpatient clinics at King Abdul-Aziz Medical City in Jeddah between 2021 and 2022. The study investigated potential risk factors and complications associated with gestational diabetes mellitus (GDM), including impaired fasting glucose/impaired glucose tolerance (IFG/IGT), family history of diabetes mellitus (DM), and medical conditions. Moreover, the study evaluated the diagnostic performance of potential predictors as screening techniques for gestational diabetes mellitus (GDM).

This study was a hospital-based retrospective cross-sectional study. The study was conducted at the clinic of King Abdul-Aziz Medical City, a tertiary care hospital in Jeddah, Saudi Arabia. Data were collected from the target population through the use of medical records.

Study Population For this study, the investigators looked at all pregnant patients who visited high-risk pregnancy outpatient clinics at King Abdul-Aziz Medical City in Jeddah from 2021 to 2022. Our focus was on singleton pregnant women who received prenatal care services in Obstetrics clinics at King Abdul-Aziz Medical City. However, to ensure accurate and valid results, the investigators excluded pregnant women with diabetes mellitus or autoimmune diseases. By examining this specific population of pregnant women, the investigators aimed to investigate potential risk factors and complications associated with high-risk pregnancies.

Sampling technique and size:

The sampling technique for this study is non-probability consecutive sampling, which will include all pregnant patients who visited high-risk pregnancy outpatient clinics at King Abdul-Aziz Medical City in Jeddah from 2021 to 2022. The study aims to collect data from all members of the target population instead of sampling from a larger population.

Data Collection Technique and Tool The data collection tool was developed and face-validated by two consultants in the field. The tool was designed to collect data from the medical records of the participants, including their fasting blood glucose (FBG) levels and oral glucose tolerance test (OGTT) results. The tool was also used to collect information about the participants' obstetric history, demographic characteristics, and medical conditions

Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnant women who received prenatal care services in Obstetrics clinics at king Abdul-Aziz medical city.

Exclusion Criteria:

* Pregnant known to have diabetes mellitus.
* Participant with Autoimmune disease.
Effect of Polyherbal Compound for Control of Blood Sugar in Impaired Glucose Tolerance and Diabetes

The aim of the study is to control blood sugar with Sugar Balance capsules which is the leaves of three herbs: ivy ground (Coccinia indica)-200mg, bougainvillia (Bougainvillea spectabilis)-30mg, Madagascar periwinkle (Catharanthus rosea)-20mg.


Eligibility Criteria:
Inclusion Criteria:

* Adult males and non-pregnant females aged ≥30 years having a diagnosis of pre-diabetes (impaired fasting glucose or impaired glucose tolerance) and a diabetes and a meeting one of the following criteria

  1. Fasting Plasma Glucose ≥100 mg/dL, fasting is defined as no caloric intake for at least 8 h, OR
  2. 2-h Post load Glucose ≥140 mg/dL during an Oral Glucose Tolerance Test (OGTT). The test should be performed as described by the World Health Organisation(WHO), using a glucose load containing the equivalent of 75 g anhydrous glucose dissolved in water. OR
  3. Glycosylated haemoglobin (A1C) ≥5.7%. The test should be performed in a laboratory using a method that is National Accreditation Board for Testing and Calibration Laboratories certified and standardized. OR
  4. In a patient with classic symptoms of hyperglycaemia or hyperglycaemic crisis, a random plasma glucose ≥200 mg/dL in the last 12 months.

Exclusion Criteria:

* Any one of the following

  1. History of diabetes onset \>12 months from date of randomization and/or on any oral hypoglycemic agents (other than metformin)
  2. Any history suggestive of micro vascular or macro vascular disease
  3. Women in childbearing age unable to practice any form of contraception
  4. Impaired renal function; estimated glomerular filtration rate(eGFR) \<60mls/min/1.73m2.
  5. Known history of any chronic illness taking regular pharmacological agents.
  6. Blood pressure fluctuations exceeding 10 mmHg on 2 subsequent clinic visits or known history of hypotension or bradycardia in last 6 months or taking 2 or more antihypertensive medications regularly in the last 6 weeks
  7. Current or former employees of organic India
  8. Participating in another clinical trial with an active intervention or drug or device with last dose taken within 60 days.
  9. Refusing consent or physician uncomfortable with patient compliance to treatments or follow up.
Prospective Double-blind Study for the Use of Aspirin During Transurethral Surgery of the Bladder or the Prostate

Aspirin is very common in older patients. Therefore many of the investigators patients have aspirin. The aim of the study is to proof that Transurethral Surgery of the bladder or the prostate can be performed with aspirin.


Eligibility Criteria:
Inclusion Criteria:

* Transurethral surgery of the bladder or prostate, informed consent, age over 18

Exclusion Criteria:

* Oral anticoagulation,
Pain and Discomfort During Maxillary Expansion

The aim of the present study is to investigate and analyze the perception of pain and function impairment during the first week of activation with two different palatal expansion screw to identify an effective pain prevention protocol.

Maxillary expansion with fixed appliance is a well-known and consolidated practice in clinical orthodontics but current findings of "evidence based dentistry" have not yet identified a better clinical expansion protocol. This issue is due both to the several expansion screws available on the market and to the different screw activation protocols, which could be grouped into rapid and slow, with several customizations. A recent systematic review has shown that both rapid and slow expansion protocols are clinically effective on the primary outcome, i.e. the resolution of the crossbite with a significant increase of skeletal transversal dimension in the maxillary transverse deficiency subjects. If the type of appliance based on its ability to solve the maxillary constriction is not any more the main selection criteria, the choice of the orthodontist should, therefore, be based on the timing and on a "patient-oriented" device, that minimizes the side effects, such as e.g. appliance breakages, functional impairments and pain.

In the orthodontic daily practice, the pain of the little patient is the most frequent symptom during treatment and is the one that most frightens/worries the child and the family. Literature shows that rapid maxillary expansion is, among the early orthodontic therapies, the one with the highest frequency of pain (up to 98%) as an adverse symptom reported by patients. The pain is statistically linked to the rapid expansion protocol (2/turn/day), during which, for each activation of the screw (0.2 or 0.25 mm) the force expressed can reach up to 10 pounds which acts in an orthopaedic manner on the palatine suture and the circummascellar sutures. Following this orthopedic action, a disorganized and highly vascularized connective tissue (inflammatory) is formed in palatine suture area, which becomes the main receptor of the pain perceived by the patient during the active maxillary expansion. In the literature the prevention and management of pain during palate expansion is a poorly analyzed topic, despite being a daily problem in orthodontic clinical practice and so the aim of the present study is to investigate and analyze the perception of pain and function impairment during the first week of activation with two different palatal expansion screw to identify an effective pain prevention protocol.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with transversal maxillary deficiency (with or without crossbite).
* Class I or Class II dental malocclusion with uni- or bilateral crossbite and/or constricted maxilla
* Before the pubertal peak (CVM 1-3).

Exclusion Criteria:

* Patients with previous orthodontic treatment
* Hypodontia in any quadrant excluding third molars
* Inadequate oral hygiene
* Craniofacial syndromes, or cleft lip or palate
Effects of a Low Glycemic Index in Obese Children

The objective of this study is to compare the effectiveness of a low-GI diet program and a standard counseling program in the treatment of obese Thai children.

Obese children aged 9-16 years from King Chulalongkorn Memorial Hospital were randomized to receive instruction either for a low-GI diet (intervention group) or a low-calorie, low-fat diet (control group). Both groups were followed-up every month for six months. The primary outcomes were body composition changes during the six-month period, measured by dual X-ray absorptiometry (DEXA) and bioelectrical impedance analysis (BIA). Secondary outcomes were metabolic syndrome risk changes measured by fasting plasma glucose, insulin, and lipid profiles.

The adherence to the nutritional education and physical activity recommendation was evaluated by using three-day dietary records (two weekdays and one weekend day) and a physical activity questionnaire at each visit. All participants were examined and counseled about physical activity and life style modification strategies by a pediatrician at every visit.

Eligibility Criteria:
Inclusion Criteria:

* Children aged between nine to sixteen years old
* BMI higher than the International Obesity Task Force cut-off

Exclusion Criteria:

* psychological problems
* underlying diseases that might affect a weight management program
* used drugs associated with weight increment or reduction
* attended other weight management programs
A Study of Ultra High Dose Diuretics to Treat Heart Failure

The purpose of this study is to determine the safety and effectiveness of ultrahigh dose diuretics compared to standard dose diuretics over 24 hours in patients with decompensated heart failure.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of decompensated heart failure receiving intravenous diuretics
* Ability to provide informed consent

Exclusion Criteria:

* Patients on home inotrope medications
* Patients with Chronic Kidney disease stage V and end stage renal failure on dialysis
* Patients lacking the capacity to consent for themselves
* Known pregnancy or breastfeeding mothers
* Complex congenital heart disease
* Allergy to furosemide or bumetanide
* Respiratory failure requiring non-invasive ventilation (CPAP/BiPAP) or invasive mechanical ventilatory support at the time of randomization
* Hypotension with systolic blood pressure \<80 mm Hg at the time of randomization
* Acute coronary syndrome
* Sustained Ventricular tachycardia requiring treatment in the last 48 hours
* Patients weighing ≤ 40 kg
Esomeprazole in Treatment of Early Onset Preeclampsia (ESOPE Trial)

Pre-eclampsia is one of the most serious complications of pregnancy affecting 3-8 % of pregnancies worldwide. It is a multi-system disorder involving maternal vessels (causing hypertension and endothelial dysfunction), the kidneys, the liver, the lungs, the hematological system, the cardiovascular system and the feto-placental unit. In its most severe form, it affects the brain, causing seizures (eclampsia), cerebro-vascular events and even death.

The key aspects in the pathophysiology of pre-eclampsia are placental oxidative stress (and hypoxia), placental release of the anti-angiogenic factors Soluble Fms Like Tyrosine Kinase -1 and soluble endoglin and maternal endothelial dysfunction. A drug that can counter these pathological steps could be a strategy to treat pre-eclampsia.

If an affordable and safe treatment was available it could temporize the disease progression of pre-eclampsia thereby delaying delivery to gain gestation. This could save the lives of many infants and decrease the hospital burden caused by iatrogenic prematurity.

Currently, there are trials investigating the possible use of pravastatin to treat pre-eclampsia, and to prevent it There are no other significant trials of orally available small molecules to treat pre-eclampsia that we are aware of.

The Translational Obstetrics Group at Melbourne University has generated strong preclinical evidence suggesting esomeprazole as one of the proton pump inhibitors may have potent actions giving it significant potential as a treatment for pre-eclampsia

Proton pump inhibitors have been commonly used in pregnancy to treat gastroesophageal reflux disorders and more serious gastrointestinal complications like Helicobacter pylori-infection, peptic and duodenal ulcers and Zollinger-Ellison syndrome.

Esomeprazole counters three key steps in pre-eclampsia pathogenesis, by up-regulating heme oxygenase-1 ( strongly decreasing the release of antiangiogenic factors Soluble Fms Like Tyrosine Kinase -1 and soluble endoglin and quenching endothelial dysfunction.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age between 28 + 0 weeks and 31 + 6 weeks
* Estimated fetal weight by ultrasound between 500 gm and 1800 gm (if gestation is not certain).
* Singleton pregnancy.
* The patient will be managed with expectant management.

Exclusion Criteria:

* Patient is unable or unwilling to give consent
* Established fetal compromise that necessitates delivery.
* The presence of any of the following at presentation:

  * Eclampsia.
  * Severe hypertension.
  * Cerebrovascular event as an ischaemic or haemorrhagic stroke.
  * Renal impairment.
  * Signs of left ventricular failure which include pulmonary oedema.
  * Disseminated intravascular coagulation (DIC)
  * Haemolysis, elevated liver enzymes and low platelets (HELLP syndrome)
  * Fetal distress on cardiotocography
* Contra-indications for expectant management of pre-eclampsia
* Current use of a proton pump inhibitor
* Contraindications to the use of a proton pump inhibitor
* Previous hypersensitivity reaction to a proton pump inhibitor
Quality of Life and Exercise Capacity in COPD

COPD patients will be examined in 4 groups according to their walking distance. Patients walking under 150 meters will be determined as Group 1, those walking between 150-249 meters will be Group 2, those walking between 250-349 meters will be selected as Group 3, and patients with COPD who walk 350 and above will be determined as Group 4. The groups were compared in terms of quality of life, psychological symptoms and dyspnea.

Quality of life affects the mortality rate independently in patients with COPD. The treatment applied in COPD does not stop the decrease in lung function, nor does it prolong the survival time. Spirometric evaluations to determine the severity of the disease are not sufficient to explain the perception of patients and their adaptation to their diseases. Therefore, evaluating the quality of life has become an important measure of treatment in COPD patients. Quality of life measurements should be done to minimize the effect of the disease, to help patients better cope with the consequences of an incurable long-term condition, and to determine modifiable factors. Identifying modifiable factors; in personalized treatment adopted in airway diseases in recent years; it is important to be able to apply appropriate pharmacological and non-pharmacological treatments Our aim is to exercise capacity in COPD patients; firstly to investigate the effect on quality of life, then to determine the relationship between emergency admission and hospitalization, dyspnea, psychological symptoms.

Eligibility Criteria:
Inclusion Criteria:

* COPD patients completed all tests and qustionnaires

Exclusion Criteria:

-