cyrilzakka/clinical-trials huggingface dataset:
An Effectiveness and Safety Study of Acetaminophen Extended Release Caplets in the Treatment of Osteoarthritis of the Hip or Knee.

The purpose of this study is to evaluate acetaminophen extended release (3900 mg/day) compared to placebo for safety and effectiveness in the relief of signs and symptoms of osteoarthritis of the hip or knee over 12 weeks

This is a randomized, double-blind, placebo controlled study to evaluate acetaminophen extended release 3900 mg/day compared with placebo in the relief of signs and symptoms of osteoarthritis of the hip or knee over 12 weeks. The hypothesis is that 3900 mg/day acetaminophen extended release is superior to placebo in the relief of signs and symptoms of osteoarthritis of the hip or knee with respect to the three primary effectiveness endpoints. Propoxyphene Hydrochloride Capsules, 65 mg, are used as rescue medication if subjects experience inadequate pain relief. The primary efficacy assessments are the average change from baseline through Week 12 for the WOMAC pain subscale score and the WOMAC physical function subscale score, and the subject's average global assessment of their response to therapy through Week 12. Safety assessments at study visits consist of monitoring adverse events, vital signs, study joint assessments and clinical laboratory determinations. Treatment consists of two acetaminophen 650 mg extended release caplets or two placebo caplets, administered orally every 8 hours for 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Symptoms of osteoarthritis of the hip or knee for a minimum of six months
* History of hip or knee pain due to osteoarthritis requiring the use of NSAIDs, acetaminophen or another analgesic agent on a regular basis (\>= three days/week) for at least three months before the screening visit
* History of positive benefit with acetaminophen use for osteoarthritis pain
* History (ie, at any time in the past since diagnosis) of osteoarthritis pain of the hip or knee when not taking osteoarthritis analgesic medication
* Subjects must report a history of a pain level of moderate, moderately severe, or severe, a WOMAC pain score \>= 65 at baseline, and a 20% or greater increase in their pain score relative to their score at screening

Exclusion Criteria:

* History of surgery, including arthroscopy, or major trauma to the study joint in the previous six months before the screening visit
* Grade 1 or grade 4 severity of the study joint based on the Kellgren and Lawrence radiographic criteria
* Signs of clinically important active inflammation of the study knee joint including redness, warmth, and/or a large, bulging effusion with the loss of normal contour at the screening and/or baseline visits
* Secondary osteoarthritis of the study joint including, but not limited to, septic arthritis, inflammatory joint disease, gout, Paget's disease of bone, articular fracture, major dysplasias or congenital abnormality, ochronosis, acromegaly, hemochromatosis, Wilson's disease, avascular necrosis, or primary osteochondromatosis
* History of acute inflammatory arthritis or pseudogout of the study joint.
Diastasis Recti Abdominis and Abdominal Muscles

Purpose of the study is the assessment of interrectal distance and dimensions of the muscles of the lateral abdominal wall in pregnant and non-pregnant women

* Purpose of the study is the assessment of interrectal distance and dimensions of the muscles of the lateral abdominal wall in pregnant and non-pregnant women
* Assessment via ultrasound measurement transabdominally
* 3 groups of participants: 1.) 20 pregnant women, who have never been pregnant before; 2.) 40 pregnant women with their first pregnancy, followed over the course of pregnancy; 3.) 20 women1-5 days after delivery (10 after spontaneous delivery, 10 after planned cesarean section)
* comparison between pregnant and non-pregnant women; evaluation of influence of pregnancy and mode of delivery

Eligibility Criteria:
Inclusion Criteria:

* non-pregnant women aged 20-45 y with a BMI \< 30 kg/m2 who never were pregnant
* pregnant women aged 20-45 y with a BMI \< 30 kg/m2 before pregnancy

Exclusion Criteria:

* abdominal pre-operations
* chronical lung diseases
* constipation
* maternal collagenosis
* polyhydramnion (AFI \> 25)
* uterus fibroids \> 10 cm
* inability to perform Valsalva
High-flow Nasal Cannula for Pediatric Anesthetic Induction

Endotracheal intubation in infants often involves more than one attempt, and oxygen desaturation is common. It is unclear whether nasal high-flow therapy, which extends the time to desaturation during elective intubation in infants receiving general anesthesia, can decrease the occurence of desaturation during intubation.

The investigators tested the hypothesis that high-flow nasal oxygen cannulae would be effective in maintaining oxygen saturation during intubation than facemasks for pre-oxygenation. The investigators randomly allocated 84 patients undergoing elective surgery aged \<=12 months to pre-oxygenation using either high-flow nasal oxygen or facemask.


Eligibility Criteria:
Inclusion Criteria:

* Infants undergoing general anesthesia with endotracheal intubation.

Exclusion Criteria:

* infants who diagnosed as cardiorespiratory problem preoperatively.
Rapid Learning for Lung Cancer

A retrospective, data mining project that re-uses routine patient care data for decision support systems.

By installing tools that extract clinical data from electronic health records and image data from the Picture Archiving and Communication System, decision support systems are built and validated that can predict survival and treatment toxicities of lung cancer patients treated with radiotherapy.

Eligibility Criteria:
Inclusion Criteria:

- Patients notes as suffering from lung cancer in at least one clinical data source.
Ocular Imaging Study Using Advanced OCT

The purpose of this study is to evaluate this AngioScan angiography software on patients with various retinal vascular disorders. The advanced OCT instrument is an FDA approved clinically used camera, but the AngioScan angiography software is not FDA approved. Investigators would like to know if this imaging device and software can improve the quality of images and visualization of imaged tissues and whether they are useful in the diagnosis and treatment of eye diseases. Images collected in this study may be compared to other images collected as part of standard of care on the same patient (OCT, FA, AF, Fundus).


Eligibility Criteria:
Inclusion Criteria:

• Any patient with abnormal retinal findings as determined by investigators.

Exclusion Criteria:

* Those suffering from head, neck or other injury which makes them unable to position themselves in head restraint for imaging.
* Participants who are unable to maintain retinal fixation on a specified target.
* Participants unable to achieve sufficient pupil dilation and alignment stability for imaging to take place.
* Patients with media opacity which preclude high quality imaging.
Mapping the Phenotype in Adults With Phelan-McDermid Syndrome

The protocol aims to comprehensively define the phenotype of Phelan-McDermid Syndrome and to identify potential genetic factors, which may play a role in the variability of the disease's outcomes. The first aim involves a physical exam, a neurological exam, collection of medical history information, a clinical genetic evaluation, blood work and neuropsychological assessments. If clinically indicated, the protocol collects information from medical tests. These medical tests may include electrocardiography, echocardiography, renal ultrasonography, and renal ultrasound.

Phelan-McDermid syndrome (PMS) or 22q13 Deletion syndrome, caused by a loss of one copy of the SHANK3 gene, is characterized by global developmental delay/intellectual disability, motor skills deficits, delayed or absent speech, and autism spectrum disorder. The goal of this study is to understand more about the PMS phenotypic outcomes and the biological pathways associated in the disorder, and to establish the foundation for future clinical trials in PMS and in other ID/ASD-associated disorders that share signaling pathways with PMS.

Individuals with PMS will be asked to participate in this study if they are 22 years of age or older with pathogenic deletions or mutations of the SHANK3 gene at time of enrollment. Both males and females will be asked to participate. Additionally, to be eligible for study participation, individuals' primary communicative language must be English. Parents and unaffected siblings may also be asked to consent to have blood drawn for analysis.

For this study, there is only one study visit. Study visit involves a physical exam, medical history questions, blood work and neuropsychological assessments. Individuals who have certain clinically indicated procedures (i.e. MRI, EEG, etc.) due will have them done as part of the research study

Eligibility Criteria:
Inclusion Criteria:

* Participant is 22 years of age and older at the time of enrollment
* Participant has been diagnosed with pathogenic deletions or mutations of the SHANK3 gene
* Participant is proficient in English
* Participant provided consent

Exclusion Criteria:

* None
Application Software in Dosage Adjustment for Advanced Cancer Patients With Pain

The purpose of this trial is to determine whether Application (APP) would help clinical doctors to adjust the dose of Oxycodone Hydrochloride Prolonged-release Tablets in advanced patients with cancer pain.


Eligibility Criteria:
Inclusion Criteria:

* a histologically confirmed diagnosis of Cancer or Sarcoma
* advanced patients with severe cancer pain(score \>3)
* having used or expected to use the Oxycodone Hydrochloride Prolonged-release Tablets

Exclusion Criteria:

* allergic to Oxycodone Hydrochloride Prolonged-release Tablets, or other reasons (determined by clinical doctors) unable to use the Opioids
Attention Training Technique in Treatment of Anxiety and Depression in Coronary Heart Disease Patients

Anxiety and depression are associated with work disability, lower participation rate in cardiac rehabilitation and unfavourable life style changes following a coronary heart disease (CHD) event. The prevalence of clinically significant symptoms of depression and anxiety in CHD patients has been estimated to 30-50%. Furthermore, depression and anxiety are associated with a significant increased risk of subsequent major adverse cardiovascular events and mortality in CHD patients. Psychological interventions for anxiety and depression in CHD patients have demonstrated small and uncertain effects of symptoms, and no effect on cardiovascular outcomes. Therefore, testing the effectiveness of specific psychological interventions that may affect central mechanisms for cardiovascular outcomes, has been requested. The Attention training (ATT) Study is a randomized controlled trial comparing group-attention training to wait-list control in 64 patients who experience significant anxiety and depression after a CHD event. It will also be explored whether reduction in psychological symptoms is correlated with changes in biological markers with a potential link to cardiovascular outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Established coronary heart disease as main somatic disease
* \>=8 on either HADS-anxiety or depression subscale
* Age 18 - 65 years
* The ability to understand and speak Norwegian language,
* Willingness and ability to give informed consent.

Exclusion Criteria:

* Current or past neurological illness
* Traumatic brain injury
* Current alcohol and/or substance dependency disorders
* Psychotic disorders
* Bipolar disorders
* Developmental disorders
* Mental retardation
* Cognitive impairment which precludes informed consent/ability to participate
* Acute suicidality
* Life-expectancy less than 12 months
* Concurrent psychological intervention for emotional distress
* Antidepressant or anxiolytic medication initiated during previous 8 weeks
Effects of MDMA on Social and Emotional Processing

The main aim of the study is to investigate the effects of ±3,4-methylenedioxymethamphetamine (MDMA; ecstasy) on social and emotional processing in healthy humans. Ecstasy is a widely used recreational drug, with over 2 million Americans reporting use of the drug in 2006. With this number of users, and evidence that high doses of MDMA are neurotoxic in laboratory animals, the public health implications of ecstasy use may be substantial. Certain subjective effects of this drug distinguish it from other stimulants, and may contribute to its widespread use: That is, users report that ecstasy produces profound feelings of empathy and closeness to others. These so-called 'empathogenic' effects, which may reflect the distinctive neurochemical profile of action of the drug, have yet to be characterized in controlled laboratory studies. The investigators propose to characterize the effects of MDMA on measures of social and emotional processing that may contribute to this 'empathogenic' profile, including measures of emotion recognition, emotional responsiveness and sociability. The investigators will assess effects of MDMA (0, 0.75 and 1.5 mg/kg up to 125 mg) one active control drug (oxytocin: 20 IU) in 100 volunteers who report some prior ecstasy use. Oxytocin will be used because it appears to produce pro-social behavioral effects resembling those attributed to MDMA.


Eligibility Criteria:
Inclusion Criteria:

* 18-35,
* healthy,
* normal weight,
* high school education,
* normal electrocardiogram,
* no psychiatric disorders,
* occasional MDMA use

Exclusion Criteria:

* current medications,
* night shift work,
* abnormal electrocardiogram,
* medical problems
Ideal Depth of Guide Wire for Central Catheterization

prospective randomized double-blind controlled study

Total of 69 ASA (American Society of Anesthesiologist) physical status class I or II patients will be enrolled.

Randomly assigned to three group according to the depth of guide-wire prior to tissue dilation during central catheterization via right internal jugular vein. (Group 1: 15 cm / Group 2: 17.5 cm / Group 3: 20 cm)

Central catheterization will be performed by anesthesiologists who be blinded to this study protocol.

An investigator will monitor and record whether any arrhythmia will occur.

The incidence of occurrence of arrhythmia will be compared between three groups.

Eligibility Criteria:
Inclusion Criteria:

* patients receiving general anesthesia requiring central venous catheterization via right internal jugular vein.
* ASA (American Society of Anesthesiologist) physical status class I or II

Exclusion Criteria:

* at the pre-anesthetic evaluation, history of any arrhythmia
* when monitoring before the induction of anesthesia in the operating room, newly arrhythmia is observed.
* abnormal electrolyte at the pre-anesthetic evaluation
* too difficult to access right internal jugular vein for central catheterization (too short neck, infection at the site of right internal jugular vein, ventriculoperitoneal shunt or chemo-port existence at the site of right internal jugular vein. too close site to operating field)
Impact of Digital Communication Assist Tools in Endoscopic Team Communication During COVID-19

Team work is highly challenged by the COVID-19 pandemic. Necessary protective equipment as FFP-mask and face shields impair communication significantly.Objective of the study is to evalaute the impact of digital enhanced telecommunication in endoscopic procedures.

Optimal communication is crucial for team work in high class endoscopy. Team work is highly challenged by the COVID-19 pandemic. Necessary protective equipment as FFP-mask and face shields impair communication significantly. Digital enhanced approaches to maintain team communication during endoscopic procedures are mandatory not only in actual circumstances.

Materials and methods:A prospective, two-armed interventional study will be performed at an endoscopy unit at a tertiary center. 200 endoscopic examinations (EGD, colonoscopy, EUS, ERCP) were randomly assigned (1:1) to a group that was performed with DECT equipped endoscopy team or with standard communication. All examinations were performed under protective equipment. Primary outcome was rate of communication associated adverse events. Secondary outcomes included team subjectively perceived comfort with DECT enhanced communication during endoscopic work, duration of examinations, SAE.

Eligibility Criteria:
Inclusion Criteria:

* Member of staff of the endoscopic team (Doctor, nurse)

Exclusion Criteria:

* Deafness
* significantly impaired hearing
The Impact of Sleep-disordered Breathing on the Incidence of Postoperative Acute Kidney Injury in Patients Undergoing Valvular Heart Surgery

Sleep-disordered breathing has a prevalence of 30\~80% in patients with heart diseases. Various studies have revealed a correlation between the incidence and various diseases such as heart failure, hypertension, diabetes, and cerebral infarction. Postoperative acute kidney injury after heart surgery is one of the major complications with incidence with 40\~50%, however, there has been no preventive method or treatment yet. Recently, several studies have been published that have shown a correlation between sleep-disordered breathing and renal impairment. In general, sleep-disordered breathing can be regulated easily with continues positive expiratory pressure, which means that early diagnosis and treatment of sleep-disordered breathing might help to reduce the incidence of postoperative acute kidney injury and improve patients' prognosis.

In this study, the investigators investigate the impact of sleep-disordered breathing (diagnosed by oxygen desaturation index ≥5) on the incidence of postoperative acute kidney injury in patients undergoing valvular heart surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Adult patient aged more than 20 years
2. Patients undergoing valvular heart surgery.

Exclusion Criteria:

1. Emergency
2. Simultaneous surgery with coronary artery bypass graft
3. Previous history of cerebrovascular accident
4. Previous history of sleep disordered breathing (diagnosis \& treatment)
5. Previous history of tracheostomy
6. Previous history of surgical treatment of airway (ex: nasopharyngeal cancer)
7. Preoperative oxygen supplement therapy
8. Patients who have participated in other clinical studies that may affect prognosis
9. Patients who cannot read and agree to informed consent (ex: foreigners, cognitive dysfunction)
Performances of a H. Pylori Stool PCR Test

Performance of a non-invasive test for the detection of Helicobacter pylori and its resistance to clarithromycin in stool by Real-Time PCR Amplidiag H. pylori + ClariR (Mobidiag).


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* indication of endoscopy with biopsies for H. pylori infection
* Free subject, without tutorship or curatorship or subordination
* Patients benefiting from a social security scheme or benefiting through a third party
* Consent informed and signed by the patient after clear and fair information about the study

Exclusion Criteria:

* Age \<18 years
* Contraindications to fibroscopy (suspicion of oesophageal perforation)
* Antibiotic intake less than 4 weeks old
* Diarrheal patients during sampling
* Patients who do not benefit from a social security scheme or who do not benefit from it through a third party
* Persons enjoying enhanced protection, namely minors, pregnant women, breastfeeding, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social institution, adults under legal protection, and finally patients in emergency situation.
* Pregnant or lactating women, women of childbearing potential who do not have effective contraception (hormonal / mechanical: oral, injectable, transcutaneous, implantable, intrauterine device, or surgical: tubal ligation, hysterectomy, total oophorectomy )
Effect of Chronic Oral Hydration in Patients With Recurrent Unexplained Syncope

Beneficial effect of chronic hydration with salt supplementation in patients with recurrent unexplained syncope is not established. We sought to determine if chronic oral rehydration with salt supplementation improved the tolerance and hemodynamic responses of patients with unexplained recurrent syncope.


Eligibility Criteria:
Inclusion Criteria:

* Syncopal and/or near syncopal episodes at least twice within the prior 3 months

Exclusion Criteria:

* Neurological disease
* Structural heart disease
* Metabolic and psychiatric illness
Formative Research Study to Address Protein Intake in Children and Analysis of Breast Milk Nutrient Content in Mothers

This formative research seeks to explore the use of egg (as a potential source of protein) as nutritional supplement for young children aged 6-8 months of either sex and breast milk composition of mothers of infants under 6 months old living in an urban slum of Dhaka city, Bangladesh.

Inadequate dietary protein intake and prolonged undernourishment can lead to short term and long-term consequences, which can deplete financial, physical, and social capital, further exacerbating the cycle of undernutrition. Subsequently, undernutrition contributes to the difficulty in achieving sustainable development and alleviating people from poverty. Children are a particular focus of interest because of the formative impact that nutrition can have on development. This is particularly relevant for the 159 million children from low and middle-income countries (LMICs) who are already stunted and many more are at risk of stunting. Understanding how to prevent child undernutrition is imperative to the future development of these children from LMICs. There is no study done so far to understand the quantity, preference and quality of egg protein intake in young children living in LMICs with high burden of undernutrition. In this context, eggs can serve as a potential source of protein to meet the unmet need of protein especially children living in resource-poor environments. Eggs contain high concentrations of choline - an important precursor of phospholipids, which can prevent adverse pregnancy outcomes, neural tube defects, changes in brain structure and function in offspring, and impaired language development during early childhood. Evidence is limited on the support of egg-related interventions for better nutrition outcomes in children from developing countries. Also there is very little evidence on the association between mother's breast milk composition with child's nutritional status.

Eligibility Criteria:
Inclusion Criteria:

(i) consuming complementary food (liquid or semi-solid or solid food) other than breast milk at least once daily; (ii) free from any acute or chronic illness (es); (iii) no known case of congenital abnormality or chromosomal disorder, and (iii) no history of micro-nutrient or food supplementation in last two weeks prior to enrollment (iv) should be breastfed but not exclusively breastfed

Exclusion Criteria:

* Children whose parents/caregivers refuse to provide informed consent will not be enrolled
Postpartum Depression in the Covid-19 Pandemic and the Impact of Anaesthesia

The aim of this multicenter prospective study is to evaluate the association between the Covid-19 pandemic maternal psychological distress with the postpartum depression, demographic and anaesthesiologic variables


Eligibility Criteria:
Inclusion Criteria:

* All pregnant women over the age of 18 that present for labour (vaginal delivery or caesarean section)

Exclusion Criteria:

* Not eligible in writing and reading in Greek
* Drug abuse