cyrilzakka/clinical-trials huggingface dataset:
Determine the Effect of Prone Positioning in Adults With ARDS by Electrical Impedance Tomography

determine the effect of prone positioning on ventilation and perfusion distribution in adults with acute respiratory distress syndrome by electrical impedance tomography

By intravenous injection of a small amount of normal saline, electrical impedance tomography enables evaluation of the pulmonary blood flow. EIT might be helpful in establishing the hypoxemia etiology at bedside via combining regional ventilation and perfusion information. The objective of this study was to describe the physiological effects of prone position on respiratory mechanics, ventilation and pulmonary perfusion in patients with ARDS.

Eligibility Criteria:
Inclusion Criteria:

* patients who were undergoing mechanical ventilation with moderate-to-severe ARDS (defined as a Pao2:Fio2 ratio \< 150 mm Hg with a positive end-expiratory pressure ≥ 5 cm of water, and an Fio2 of ≥ 0.6) according to the Berlin definition

Exclusion Criteria:

* contraindications to the use of EIT (e.g., presence of pacemaker or chest surgical wounds dressing)
Swallowing Characteristics of Pediatric Patients With Eosinophilic Esophagitis

Eosinophilic Esophagitis (EoE) can affect patients all age group and clinical symptoms of the disease varies depending on the patient's ages. Infants and toddlers with EoE generally have food refusal, vomiting and poor weight gain. Older school-aged children and adolescents may have abdominal and chest pain, difficulty in swallowing (dysphagia) especially in solid foods. In the meantime, many children especially infants and toddlers, are not perceptive of their dysphagia, because they have the ability to compensate. Such as, avoiding certain textures or increases liquid intake in the meal.To date, to our knowledge, there is no study in the literature has investigated complex swallowing behaviour (including all phases), oral-motor evaluation and/or swallowing safety. Thus, the present study purposed to investigate (a) descriptive and clinical swallowing characteristics of children with EoE (b) the relation between disease characteristic and swallowing function.


Eligibility Criteria:
Inclusion Criteria:

* Children and adolescents aged 2-17 years with a diagnosis of Eosinophilic Esophagitis

Exclusion Criteria:

* Do not accommodate the study
* Do not want to attempt the study
Combination Pill of Losartan Potassium and Hydrochlorothiazide for Improvement of Medication Compliance Trial

The purpose of the study is to determine whether combination pill of losartan potassium and hydrochlorothiazide will improve medication compliance among patients with high blood pressure.

Despite clear evidence that blood pressure lowering treatment is beneficial for reduction of cardiovascular disease, blood pressure levels are not adequately controlled in many hypertensive patients. More intensive blood pressure lowering treatment is required to achieve maximum reduction of cardiovascular disease. Combination pills of blood pressure lowering drugs could be a safe and effective strategy to achieve blood pressure target but there is no randomized evidence that established the beneficial effects of combination pills of blood pressure lowering drugs. The purpose of the study is to determine whether combination pill of losartan potassium and hydrochlorothiazide will improve medication compliance among patients with high blood pressure.

Eligibility Criteria:
Inclusion Criteria:

* Aged 20 years or above
* Hypertension defined as blood pressure levels of \>/=140/90mmHg or current use of blood pressure lowering drugs
* Able to commence combination therapy of angiotensin receptor antagonists and diuretics

Exclusion Criteria:

* Blood pressure measurements of \>/=200/120mmHg
* Previous serious adverse events due to angiotensin receptor antagonists or diuretics
* Known or possible pregnancy
* Known severe liver dysfunction
* Known severe kidney disease
* Known contraindication to angiotensin receptor antagonists or diuretics
* Taking \>/=4 tablets except for angiotensin receptor antagonists
* ACE inhibitors, thiazide or thiazide-like diuretics in the morning
* Current participation in another clinical trial
* A high likelihood that the patient is not suitable for the study treatment
DHA Supplementation and Pregnancy Outcome

The purpose of the study is to determine if increasing DHA intake during pregnancy can increase gestation duration and enhance infant and childhood outcomes related to visual acuity, stereoacuity, attention, and distractibility.

Although numerous trials show benefits of postnatal DHA supplementation for visual acuity and others show benefits for cognitive function and/or attention, studies of increased DHA exposure during fetal life are needed, especially in the US. Women in the US consume low amounts of DHA compared to other world populations, and this likely means less DHA transfer to the fetus than in many other populations. Prenatal DHA exposure may be more important than postnatal exposure, because animal studies show critical windows for brain DHA accumulation in relation to effects on neurotransmitters such as serotonin, dopamine and GABA.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant 8-20 wks at enrollment
* single fetus
* BMI \<40

Exclusion Criteria:

* diabetes (Type I, ii, GDM)
* hypertension (primary, PIH, preeclampsia/eclampsia)
Pre-operative Aceclofenac on the Anesthetic Efficacy of IANB in Symptomatic Irreversible Pulpitis

The aim of this randomized, double-blinded, controlled study is to evaluate the effect of pre-operative oral aceclofenac on the success of the inferior alveolar nerve block with 2% Mepivacaine containing 100,000 Epinephrine for patients with symptomatic irreversible pulpitis.

* The aim of this randomized, double-blinded, controlled study is to evaluate the effect of pre-operative oral aceclofenac on the success of the inferior alveolar nerve block with 2% Mepivacaine containing 100,000 Epinephrine for patients with symptomatic irreversible pulpitis.
* Patients will be clinically and radiographically examined and their eligibility will be assessed and preoperative pain will be measured using Heft-Parker VAS. Eligible patients will be treated in one visit.
* Patients will be randomly assigned to one of 2 groups: experimental group (taking a 100 mg of Aceclofenac) and the control group (taking a placebo tablet). Each tablet will be taken one hour before starting treatment. After 15 minutes of the initial inferior alveolar nerve block (IANB), the teeth will be examined using a cold pulp sensitivity test; in case of no or mild pain, the treatment will be initiated otherwise, additional IANB will be administered.
* During root canal treatment, no to mild pain response will be considered success. In case of failure, supplemental anesthesia will be administrated.

Eligibility Criteria:
Inclusion Criteria:

* Patients in good health (American Society of Anesthesiologists Class I or Class II).
* Patients having symptomatic irreversible pulpitis in one of their mandibular molars
* Age is 18 years or older.
* Patients who can understand Heft- Parker Visual Analogue Scales.
* Patients able to sign informed consent.

Exclusion Criteria:

* Patients allergic to aceclofenac or Mepivacaine.
* Pregnant or nursing women.
* Patients having active pain in more than one molar in the same quadrant.
* Administration of analgesics within 12 h before the administration of the study drug.
Opportunstic Hepatitis C Virus Treatment

The project will assess the effect of opportunistically treating hepatitis C virus (HCV) infection immediately when HCV-infected people who inject drugs are hospitalized for acute care in psychiatric, interdisciplinary specialized drug treatment or somatic wards. We will compare this approach with the current standard of care (SOC), which is referral to the outpatient clinic at the medical department following discharge.

The overall objective is to show that opportunistic and immediate administration of HCV treatment is more efficient compared to referral-based SOC. The specific objectives are: 1) to compare the intervention and SOC groups with regards to treatment completion, treatment uptake and virologic response ; 2) to assess the rate of reinfection after successful HCV treatment; and 3) to assess the frequency of resistant associated substitutions before and after virologic treatment failure.

We will use a stepped wedge design and include patients in 7 clusters

Following randomization of the cluster to the immediate treatment, physicians at the participating wards will be notified in writing that for the next time period patients diagnosed with HCV infection should be treated immediately. In addition, lectures presenting the opportunistic approach will be given and the Department of Microbiology will add a brief text to the result of HCV RNA testing reminding about the opportunistic approach. In the medical and the psychiatric departments, consultants from the departments of infectious diseases or gastroenterology will prescribe immediate treatment. In the departments that provide addiction treatment, local physicians will prescribe treatment. Treatment will be prescribed in accordance with current Norwegian treatment recommendations. The intensity of care after discharge will be individualized at the discretion of the treating physician.

Eligibility Criteria:
Inclusion criteria

* Above 18 years of age
* HCV RNA positive
* Inpatient at participating ward
* Signed informed consent must be obtained and documented according to national and local regulations

Exclusion criteria:

* Pregnancy or breastfeeding.
* In involuntarily health care.
* Ongoing treatment of hepatitis C.
* Current participation in another trial that might affect the current study.
* Any reason why, in the opinion of the investigator, the patient should not participate (e.g. not able to comply with study procedures).
Novel Porous Bioceramic Material as a Bone Substitute

The aim of this study is to demonstrate that new synthetic bone graft bioceramic composites (Adaptos®-Si and Adaptos®, Biomendex Oy) are able to support the preservation of the alveolar ridge and to promote bone regeneration following dental extraction. New bone graft substitutes are compared with already existing treatment principles used following dental extraction.

The primary hypothesis of the study is that Adaptos®-Si granules can reach a clinical outcome superior to that of dental socket left empty after extraction. Secondary aim is that new bioceramic composites can reach a clinical outcome non inferior to the active comparator of this study (Geistlisch Bio-Oss®).

The purpose of this study is to evaluate new synthetic Adaptos®-Si and Adaptos® in ridge preservation bone grafting after dental extraction. This is partly randomized, subject and outcome assessor-blinded, controlled, single center study. The total study duration for each patient is planned to be 10 months. In total 4 visits per patient are scheduled in this study.

Subjects will undergo a single tooth extraction and then will be randomized to receive one of the four bone graft substitutes, which are Adaptos®-Si (one of the the two granula sizes), Adaptos®, or Geistlich Bio-Oss®. Gelatin sponge is applied on the bone graft filled extraction socket. Non-randomized part of the study includes the patients that have chosen the conservative treatment option with dental socket left empty and no intention for dental implant placement. Following a healing period of 5 months, a dental implant will be placed, unless the patient has chosen the empty socket. The subject will be followed for ten months following tooth extraction. Bone ridge horizontal and vertical change assessment will be done by CBCT (primary and secondary outcome) at the time of tooth extraction, and 5 months and 10 months post-extraction.

The study device Bio-Oss® (Geistlich Pharma) and Spongostan Absorbable Haemostatic Gelatin Sponge (Ferrosan Medical Devices) are CE-marked. The products are used within the indication.

Eligibility Criteria:
Inclusion Criteria:

* Patient must have voluntarily signed the informed consent
* Females and males, 18 years to 80 years of age
* Patient needs single tooth extraction of 1st or 2nd premolar or molar tooth
* At least one adjacent teeth present
* At least 3 intact walls
* Subjects must be committed to the study and the required follow-up visits

Exclusion Criteria:

* Planned radiation or radiation during previous year in the tooth extraction area.
* Smoking
* Osteoporosis
* Uncontrolled periodontitis
* Alcohol or drug abuse
* Pregnant or breastfeeding women
* Uncontrolled diabetes
* Local acute or chronic infection or presence of oral lesions or trauma
* Immunosuppressive disease, treatment, or medication
* Subject is part of the investigator team of this study or investigator's family member
* Subject is employee of one of the organizations involve in this study
Transcranial Direct Current Stimulation for Cognitive Improvement in Parkinson's Patients

The investigators hypothesize that multi-session anodal tDCS (atDCS) of the left dorsolateral prefrontal cortex (LDLPFC) will induce long-lasting effects in improving cognitive function and reducing cognitive fatigue and fatigability in PD patients.

Parkinson's disease (PD) is the second most common neurodegenerative disease (after Alzheimer's disease) and affects approximately one million people in the United States. Mild Cognitive Impairment (MCI) is very common even in early stages of PD. In addition to cognitive impairment, patients with PD also suffer cognitive fatigue (defined as the general sensation of difficulty in initiating cognitive activity) and cognitive fatigability (defined as "deterioration in the performance of attention tasks over an extended period of time"). Cognitive impairment, cognitive fatigue, and cognitive fatigability affect quality of life in patient with Parkinson's disease.

Transcranial direct current stimulation (tDCS) is a noninvasive and safe brain stimulation technique that has been shown to be effective in improving cognitive function in subjects with Parkinson's disease. During tDCS, low-voltage, low amplitude current is passed through a pair of surface electrodes placed over the areas of brain of interest.

The specific aim of this study is to examine if atDCS to LDLPFC at 2 milliamps (mA) for 20 minutes daily for 5 days will improve cognitive function and reduce cognitive fatigue and fatigability in PD patients with MCI. The study will examine if the effects may last for two weeks.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of PD with at least two of the four diagnostic criteria for PD (tremor, rigidity, bradykinesia, and postural instability)
* Meets criteria for MCI (21 ≤ MOCA scores ≤ 26)
* Must be able to consent

Exclusion Criteria:

* Patients with dementia (MOCA \< 21)
* PD treatment using deep brain stimulation (DBS)
* Diagnosis of psychosis
* Diagnosis of multiple sclerosis
* Diagnosis of stroke
* Diagnosis of epilepsy
* Diagnosis of chronic obstructive pulmonary disease
* Diagnosis of congestive heart failure
* Diagnosis of renal failure
* Participants not fluent in English
The Soft Tissue Mobilization Techniques on PMS

The aim of this study is investigate the effects of progressive relaxation and myofascial release technique on blood flow velocity, pain, premenstrual symptoms and quality of life in premenstrual syndrome patients. There are tree groups in the study. These groups are; progressive muscle relaxation group, myofascial relaxation technique and control group. Evaluations will be made by another physical therapist who is blinded to the groups. Participants will be evaluated within the first 3 days of their menstrual cycle. Baseline assessment and post- treatment assessment will be done. Follow-up evaluation will be done on the fifth cycle, two cycles after the post-treatment evaluation.

The aim of this study is investigate the effects of progressive relaxation and myofascial release technique on blood flow velocity, pain, premenstrual symptoms and quality of life in premenstrual syndrome patients. The study planned as a single-blind randomized controlled trial. The volunteers who were invited to the study and signed the voluntary consent form will be randomized via random allocation software to divided into 3 groups. These groups are; progressive muscle relaxation group, myofascial relaxation technique and control group. Evaluations will be made by another physical therapist who is blinded to the groups. Participants will be evaluated within the first 3 days of their menstrual cycle. Baseline assessment will be done in the first 3 days of the first cycle, after first treatment acute assessment will be done. Post-treatment evaluation will be done in the first 3 days of the 3rd cycle after treatment for two cycles. Follow-up evaluation will be done in the first 3 days of the fifth cycle, two cycles after the post-treatment evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Pain score of 4 cm or more according to the Visual Analogue Scale.
* Having a regular menstrual cycle for 12 months (24-35 days).
* According to the International Physical Activity Questionnaire-Short Form (IPAQ-SF), the weekly Metabolic Equivalent of Task (MET) value is below 600 MET-min/week.

Exclusion Criteria:

* Those who have undergone surgery in the last 6 months,
* Those who use cigarettes and alcohol,
* Those who are pregnant,
* Those with urinary, genital, gastrointestinal disorders,
* Those who have had hysterectomy surgery will be excluded.
Bioequivalence Study Between 400 mg LX4211 Tablets and 2 X 200 mg LX4211 Tablets

This is a randomized, single-center, open-label, 2-sequence, 2-period, single-dose, crossover study to assess the bioequivalence and the total 24-hour urinary glucose excretion (UGE) of 400 mg LX4211 administered as a single 400-mg tablet compared to 2 × 200-mg tablets in healthy subjects under fasted conditions.


Eligibility Criteria:
Inclusion Criteria:

* Adult subjects ≥18 to ≤55 years of age
* Willing and able to provide written informed consent

Exclusion Criteria:

* Presence of clinically significant physical, laboratory, or ECG findings that, in the opinion of the Investigator and/or Sponsor, may interfere with any aspect of study conduct or interpretation of results
* Existence of any surgical or medical condition that might interfere with the absorption, distribution, metabolism, or excretion of LX4211
* History of renal disease, or significantly abnormal kidney function test at Screening
* History of hepatic disease, or significantly abnormal liver function tests at Screening
* History of any clinically relevant psychiatric, renal, hepatic, pancreatic, endocrine, cardiovascular, neurological, hematological, or GI abnormality
Eosinophilic Airway Inflammation and Mepolizumab

A drug (mepolizumab) that reduces allergic inflammation will affect the function of allergy cells called eosinophils which are produced by the body in response to allergen exposure.


Eligibility Criteria:
Inclusion Criteria:

* Males or females age 18 to 50 yrs,
* History of asthma based upon presence of asthma symptoms such as cough, shortness of breath, wheeze or chest tightness,
* positive skin-prick test to a House Dust Mite extract,
* Forced expiratory volume at one second \>70% predicted pre-albuterol, \> 80% predicted post albuterol
* \>12% increase in Forced expiratory volume at one second following inhaled albuterol (180 µg) and/or
* airway responsiveness to methacholine (PC20 \<8mg/ml).
* \> 20% immediate drop in FEV1 following inhaled antigen challenge.
* Safety laboratory assessments within normal ranges (labs to include complete blood count with differential, blood urea nitrogen, creatinine, aspartate aminotransferase, alanine aminotransferase, Prothrombin time, Partial Thromboplastin Time, and platelet count)
* Female subjects of child-bearing potential must have a negative urine pregnancy test (urine HCG) within 48 hours of the methacholine challenge at Visit 2 and agree to use a reliable method of birth control for the duration of the study (reliable methods of birth control can include abstinence, barrier methods, oral contraceptives, injection contraceptives or skin absorption contraceptives).
* In the opinion of the investigator, capable and willing to grant written informed consent and cooperate with study procedures and requirements.

Exclusion Criteria:

* Use of inhaled or systemic corticosteroids or leukotriene inhibitors within 1 month of screening.
* Treatment with Omalizumab (anti-IgE) within 9 months of screening visit
* Concomitant use of any other monoclonal antibody
* Respiratory infection within 4 weeks of study
* Unstable asthma as indicated by self-report of increased symptoms or increased beta-agonist use over the previous 2 weeks.
* Female subjects who are pregnant, nursing or have a pregnancy planned during the course of study
* Current smokers (defined as smoked within the last year) or a former smoker with a history of \>5 pack years.
* Major health problems such as heart disease, type I and II diabetes or lung diseases other than asthma. Decisions regarding this criteria will be based upon the judgment of the investigator.
* Previous malignancy.
* Medication other than for asthma, allergies or contraception and that the investigator feels may interfere with the conduct of study (e.g. monoamine oxidase inhibitors and B-adrenergic antagonists in any form)
* Known history of allergic reaction to previous antibody administration.
* Prior treatment with an anti-interleukin-5 monoclonal antibody,
* Use of an investigational drug within 30 days of entering the study,
* History of noncompliance with medical regimens or subjects who are considered unreliable.
Endothelial Damage and Angiogenesis Biomarkers During COVID-19

Severe SARS-CoV-2 disease is characterized by a progressive hypoxemic respiratory failure. Autopsies from these patients show severe endothelial damage with extensive vascular thrombosis, microangiopathy, and occlusion of alveolar capillaries and, finally, evidence of new vessel growth through intussusceptive angiogenesis.

This research aims to study endothelial damage and angiogenesis biomarkers and its association with major cardiovascular events.

To study the presence of endothelial damage and angiogenic biomarkers with major cardiovascular events, the investigators will perform an observational study to evaluate plasma biomarkers concentrations in Covid-19 patients hospitalized in critical care units.

After ethical review board approval, the investigators will select 40 patients admitted to intensive care units (ICU). After patient written consent or if the participants are unable to consent, after a relative subrogated acceptance, the investigators will collect blood samples in the first 24 hrs and on the 10th day of hospitalization.

Venous blood samples are collected. After obtaining all samples, serum Syndecan-1, thrombomodulin, ANG-2, FGF basic, HGF, IL-8, PDGF-BB, TIMP-1, TIMP-2, TNFα y VEGF will be determined by a researcher blinded to the patient using commercially available Elisa kits. The concentration of each biomarker at each sample time will be compared. The investigators will observe clinical outcomes after one, 3, 6, and 12 months after the hospitalization.

The investigators found no previous data of this measurement in the COVID-19 scenario. In this observational study, the investigators select a sample size on convenience for the primary outcome.

Eligibility Criteria:
Inclusion Criteria:

1. Patients older than 18 years
2. Patient with a diagnosis of COVID-19 confirmed by PCR
3. Patient with radiological image suggestive of COVID-19 with pending confirmation
4. Need for ventilatory support with oxygen therapy by HFNC (High-flow nasal cannula)
5. Need for invasive mechanical ventilation.

Exclusion Criteria:

1. Patient with an image suggestive of COVID-19 with negative PCR
2. Anticoagulation users before admission for any reason.