cyrilzakka/clinical-trials huggingface dataset:
Nasal HFOV Versus Nasal SIPPV in Neonate Following Extubation: RCT Crossover Study

Mechanical ventilation was introduced to treat respiratory failure in preterm infants or sick neonates then improvements in survival (1,2). However, the complications from short or long term use of ventilation can result in unintended harm or burden (e.g., air leak syndrome, pneumonia, bronchopulmonary dysplasia, neurological injury, retinopathy of prematurity) (3,4). To reduce these risks, clinicians should aggressive extubated neonates as early as possible. Respiratory (focus on blood gas as well as partial pressure CO2 \[pCO2\]) or extubation (focus on clinical condition as well as reintubation) failure was worrisome in pediatrician and parents if the neonate was reintubated owing to complete recovery of lung disease or inadequate respiratory drive.

Non-invasive ventilation (NIV) was supported for primary respiratory support (initial mode before endotracheal intubation) or post-extubation. Nasal continuous positive airway pressure (nCPAP) was familiar to NIV mode in neonatal respiratory support. Nowadays, the new NIV modalities are nasal intermittent synchronized positive pressure ventilation (nSIPPV) and nasal high frequency oscillation (nHFO). To increase the likelihood of nCPAP success, other new modalities of NIV may be interesting. From theory, nSIPPV and nHFO combines peak inspiratory pressure (PIP) with synchrony and high-frequency oscillations without synchrony above CPAP, respectively. From meta-analysis, nSIPPV and nHFO were statistically significant superior than nCPAP both respiratory and extubation failure in neonate (5,6).

The aim of our study was to investigate the efficacy of nHFOV and nSIPPV for CO2 clearance and reintubation rate after extubated neonates. The investigators hypothesized that nHFOV mode would improve CO2 clearance better than nSIPPV mode.

The primary outcome (pCO2) was measured by crossover RCT. The secondary outcome (reintubation within 7 days) was measured by paralleled RCT.

Eligibility Criteria:
Inclusion Criteria:

* Born in hospital and admit in NICU
* The first endotracheal intubation and need NIV if extubation
* Umbilical arterial catheterization to draw the blood gas
* Neonate has not been intervened from another RCT study

Exclusion Criteria:

* Major congenital anomalies or chromosomal abnormalities
* Neuromuscular diseases
* Upper respiratory tract abnormalities
* Suspected congenital lung diseases or pulmonary hypoplasia
* Need for surgery known before the first extubation
* Grade IV intraventricular hemorrhage occurring before the first extubation
* Palliative care
* Parents' decision not to participate
The Effect of Probiotics in HIV-1 Infection

HIV progression is closely associated with chronic immune activation driven by leakage of bacterial products from a damaged gut, the investigators largest immunological organ. Notably, the degree of immune activation has been suggested to be a better predictor of disease progression than plasma viral load, and markers of immune activation and gut damage have been identified as therapeutic targets per se. The major damage by HIV to the immune system is an initial massacre of gut mucosal CD4+ Th17 cells. Interestingly, a normal gut flora has been shown to induce the maturation of Th17 cells in the small intestine mucosa. Preliminary reports have shown that the gut flora is altered in HIV-1 infection compared to controls. In this project, the investigators will characterize microbial composition of gut flora in chronic HIV infection with ultradeep sequencing. Gut flora composition will be related to clinical data as well as quantitative data of circulating microbial products and activation markers. Second, in a randomized clinical trial (RCT) the effect of probiotic lactobacilli on HIV pathogenesis and progression will be tested. This Gram-positive strain is clinically tested and is able to colonize the gut.

Objectives:

To explore (i) the safety and tolerability, and (ii) the efficacy of probiotics on HIV-associated microbial translocation, systemic immune activation, disease progression and composition of gut microbiota in chronic HIV-1 infection.

Methodology/Study design:

Approximately 50 patients without current indication for antiretroviral treatment (ART) and 50 patients receiving ART without normalised CD4 counts will be included. A controlled clinical trial will be carried out within each stratum randomised in a 2:1:1 fashion to double blinded intervention and placebo arms as well as an open, untreated control arm, respectively.

Eligibility Criteria:
Inclusion Criteria:

* For patients without ART: Confirmed diagnosis of HIV infection \> 6 months and CD4+ T cell count \< 900
* For patients on stable, effective ART: HIV RNA \< 50 copies/ml \> 6 months and CD4+ T cell count \> 500
* Signed informed consent.

Exclusion Criteria:

* Severe illness requiring hospitalization
* Systemic antibiotics or probiotics the last two months
* Current immune modulating therapy
* Infectious diarrhea
* Inflammatory bowel disease
* Acute primary HIV infection
* Patients immigrating from Africa, Asia or Latin-America within the last 6 months.
Electronic Alert for Acute Kidney Injury in Geriatric Wards

Operating acute kidney injury electronic alert in geriatric wards; Acute authenticity evaluation of acute kidney injury electronic alert; To explore the clinical value of electronic alert for acute kidney injury prevention and treatment in geriatric wards.


Eligibility Criteria:
Inclusion Criteria:

* Age over 65 years old
* Diagnose of acute kidney injury by e-alert

Exclusion Criteria:

* Baseline serum creatinine \> 4mg/dL
* Stage-5 chronic kidney disease or maintenance hemodialysis
* Kidney transplantation
* Amputation
An Oral GnRH Antagonist to Treat Mild Autonomous Cortisol Excess (MACE) Due to Adrenal Adenomas in Postmenopausal Women

The purpose of this research study is to determine if treatment with Elagolix will improve body weight, waist circumference, muscle strength, cortisol secretion, blood glucose, cholesterol, and bone quality as well as mood and quality of life in a female patient with mild hypercortisolism from adrenal overproduction of cortisol. Many people with adrenal nodules, or non-cancerous growths in the adrenal glands, have mildly elevated cortisol levels. Cortisol is a hormone normally made by the adrenal glands. It is increasingly being recognized that even mild elevations in cortisol levels can negatively impact blood glucose levels, serum cholesterol levels, weight and other metabolic parameters. This can lead to an increase in risk for cardiovascular disease. The study team is trying to determine if the medication Elagolix might be an effective treatment for post-menopausal females with mild hypercortisolism. Elagolix is a medication used to treat a medical condition called endometriosis by decreasing the body's production of sex hormones. Growth of adrenal adenomas is thought to be driven by such sex hormones. Therefore, by decreasing production of these hormones, the study team hopes to treat hypercortisolism caused by adrenal adenomas.


Eligibility Criteria:
Inclusion Criteria:

* Post-menopausal women that have incidentally found adrenal adenomas with benign appearing characteristics on imaging (\<4 cm, non-contrast CT \<10 HU and/or lipid rich and benign appearing on MRI)
* Absence of anti-anabolic clinical features of overt Cushing's signs (proximal muscle weakness, \>three ecchymoses, hyperpigmented striae) and 2 of 3 of the following:

  * Elevated 24 hr urine free cortisol (UFC) above the upper limit of normal (\>50 mcg/24 hours) in at least two complete 24-hour tests and/or
  * Late night salivary cortisol more than upper limit of normal in at least two tests and/or
  * an abnormal dexamethasone suppression defined as post 1mg dexamethasone suppression test serum cortisol concentration of \>1.8 mcg/ml
* Clinic status of cessation of menses for 12 mo in a previously cycling woman and reflecting complete or nearly complete permanent cessation of ovarian function and fertility (26).
* Patients with osteoporosis that are not receiving treatment with either antiresorptive medications (bisphosphonates, denosumab) or anabolic agents (teriparitide, abaloparatide or romosozumab)

Exclusion Criteria:
Adding Vertical Correction to Scapular Recognition on Patients With Frozen Shoulder

OBJECTIVE: To study the effect of adding a continual vertical downward correction to dynamic scapular recognition exercise on scapular dyskinesis and shoulder pain and disability in patients with frozen shoulder.

Design: A double-blinded randomized controlled study Setting: Out-patient clinic Subjects: Sixty-seven subjects with unilateral frozen shoulder Interventions: Participants were distributed into two groups. The intervention group performed the dynamic scapular recognition exercise and continual vertical downward correction using rigid taping with 50%-75% tension. The control group performed a similar dynamic scapular recognition exercise using a wireless biofeedback system and placebo taping. A scapular dyskinesis test with caliper was utilized to measure scapular dyskinesis, a digital inclinometer was utilized to evaluate the scapular upward rotation and shoulder ROMs, and the Shoulder Pain and Disability Index (SPADI) was utilized to evaluate the shoulder pain and disability.


Eligibility Criteria:
Inclusion Criteria:

* The existence of a unilateral frozen shoulder with incapability of the participant to raise the arm more than 100 degrees in the plane of the scapula.
* Aa restriction in both passive and active shoulder ROM
* The existence of pain that affects performing activities of daily living\[19\]

Exclusion Criteria:

* The presence of any shoulder problem contraindicated for performing exercises to the shoulder joint, such as active inflammatory disease, cancer, active infection, recent subluxations or dislocations, fractures, and surgeries nearby the shoulder region. Furthermore, the patient was excluded if he/she had no signs of scapular dyskinesis.
Clinical and Radiographic Outcomes After AMIC Treatment for Talus Osteochondral Lesion Trattamento Artroscopico Delle Lesioni Osteocondrali Dell'Astragalo Con Tecnica AMIC

Aim of the study is to evaluate clinical and radiographic outcomes in patients undergone all-arthroscopic autologous matrix induced chondrogenesis for symptomatic osteochondral talar lesions


Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years
* males and females
* patients underwent arthroscopic cartilage reconstruction surgery with AMIC technique for osteochondral lesions of the talus

Exclusion Criteria:

* age \<18 years at the time of surgery
* patients with previous surgery on the affected ankle
Suprazygomatic Maxillary Nerve Block in Cleft Palate Outcomes

Increased pain after cleft palate surgery is the leading cause of increased hospital length of stay, delayed oral intake, readmission, and respiratory compromise. The goal is to improve all outcomes by identifying the most effective evidenced-based method of intra-operative pain control.

Cleft palate repair is associated with significant perioperative pain that may require increased depth of anesthesia intraoperatively and can interfere with oral intake and accentuate breathing difficulties postoperatively, resulting in increased length of hospital stay. Optimizing pain control in the perioperative period is essential to best practice for cleft palate repair. Infiltration of the palate with local anesthetic has long been the established mechanism for pain control to minimize intraoperative anesthetic requirement and postoperative opioid use. Suprazygomatic maxillary nerve block (SMB) administered immediately prior to cleft palate repair by anesthesiologists with fellowship training in regional anesthesia is an emerging technique for local anesthetic infiltration. The latter technique is thought to provide superior pain control due to its precise and targeted action on the nerves that innervate the palate, and because it is felt that duration of action may also be prolonged due to specific infiltration around these nerves as opposed to generalized infiltration in the palatal soft tissues. The goal of our study is to evaluate outcomes following the two routes for anesthetic infiltration during cleft palate repair. If either technique is found to be more effective or of greater duration, this can have direct impact in decreasing the need for perioperative opioid use, decreasing hospital length of stay, and less potential for airway suppression from excessive use of postoperative analgesics.

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing primary cleft palate repair at Ann \& Robert H. Lurie Children's Hospital of Chicago during the enrollment period. The typical child at the time of cleft palate repair is age 11 to 12 months.

Exclusion Criteria:

* Children with a known allergy to local anesthesia (i.e., ropivacaine or bupivacaine).
* Children with prior surgical repair of the palate.
DuraSeal Sealant Post Market Study

DuraSeal Dural Sealant has been approved as a dural sealant by the FDA for use in cranial and spinal procedures. This study was completed to further evaluate the safety of the DuraSeal Sealant in a post-approval setting as compared to control (defined as methods typically employed by surgeons to seal the dura).


Eligibility Criteria:
Inclusion Criteria:

* Patient is between 18 and 75 years of age
* Patient is scheduled for an elective cranial procedure that entails a dural incision
* Evidence of intraoperative non-watertight closure
Postprandial VLDL-TG Metabolism

In thise study, we aim to determine the effect of meal fat on VLDL-TG kinetics in type 2 diabetic and healthy subjects matched for BMI in order to elucidate the potential pathophysiological differences in VLDL-TG FA channeling towards oxidation and storage in abdominal and leg subcutaneous adipose tissue. Specifically, we want to measure, by way of fat and muscle biopsies, the quantitative postprandial storage of VLDL-TG FA's in skeletal muscle and adipose tissue in relation to a series of tissue specific proteins and enzymes that might be involved in regulating skeletal muscle and adipose tissue FA storage.


Eligibility Criteria:
Inclusion Criteria:

* Written consent

Exclusion Criteria:

* Known diseases
* Alcohol abuse
* Smoker
* Regular use of medicine
Implementation of ProMuscle in Daily Practice

Implementation of a previously shown (cost-)effective combined lifestyle intervention for community living older adults, ProMuscle, in at least four of the eight communities of the 'Foodvalley' in the Netherlands.

ProMuscle is a combined lifestyle intervention that has been shown effective in improving muscle mass, muscle strength, and physical functioning in community-dwelling older adults. Potentially, it could facilitate older people in maintaining their functional independence.

Despite the promising results, ProMuscle is still not part of daily care. Previously factors influencing successful implementation were identified and implementation strategies targeting these factors were developed and formatted as an implementation toolbox for healthcare professionals.

To increase the likelihood of successful implementation of ProMuscle, this study aims to investigate the PUMP-fit strategy (implementation toolbox) effectiveness on the adoption of ProMuscle in community-care

A hybrid type 3 stepped wedge cluster trial with a mixed method analysis will be conducted to assess the effectiveness of the PUMP-fit implementation toolbox. A stepped wedge trail is chosen because of the ability to compare between clusters, but also within clusters.

Moreover, ProMuscle is already found effective, and the researchers hypothesized that the implementation toolbox should be assessable for all healthcare professionals in the 'Foodvalley'. At last, a stepped wedge design is recommended if there is limited time and a small sample of professionals to recruit from in comparison to the total sample size that is needed to detect any effect.

In addition, the researchers hypothesized that the program would be adapted to specific contexts' outcomes from the recipients of ProMuscle will be collected. A hybrid type three trial aims to investigate the implementation as a primary outcome and the effect of the (adapted) intervention as a secondary outcome.

Eligibility Criteria:
To be eligible to participate in this study, healthcare professionals must met the following criteria:

* Physical therapist, lifestyle coach or dietician in one of the communities in the Foodvalley in the Netherlands
* Interested in combined lifestyle programs for older adults
* Frequently involved in maintaining physical functioning in older adults

In and exclusion criteria for older residents receiving ProMuscle are:

Inclusion criteria:

* Aged 65 years or older
* Living in one of the eight communities of the 'Foodvalley' (Ede, Wageningen, Nijkerk, Rhenen, Veenendaal, Barneveld, Scherpenzeel, Renswoude)
* Able to understand Dutch
* Are pre-frail or frail (score 1 or more points on the Fried frailty criteria), or report loss of muscle strength

Exclusion criteria:

- One or more red flags for participating in progressive resistance exercise without consent of a medical specialist or general practitioner
Echocardiography in Critically-ill Patients With COVID-19 Pneumonia

Critical care echocardiography (CCE) has been widely used since the 10 last years. Covid outbreak leads that many patients with acute respiratory failure were admitted in the ICU. Many of these patients were ventilated and developed ARDS. Some of them developed deep vein thrombosis and pulmonary embolism. Nothing is already described about the cardiac function and the hemodynamics in these patients (how many RV failure, LV systolic dysfunction,...). The echo group of the cardiodynamix section of European society of intensive care medicien (ESICM) aims to promote CCE and evaluate its interest. The objective is to retrospectively enter in an international database all the echo studies done as usual care in these patients to evaluate (i) incidence of RV failure, (ii) incidence of LV systolic function, (iii) incidence of other patterns. Another objective will be to look for any association between some patterns and respiratory strategy, blood gas analysis, systemic hemodynamics. The echo studies were done and will be reported following one of the recent systematic review published by the same group (Huang S et al. AOIC 2020).

Multicenter, international observational retrospective study. Patients admitted in the ICU between March 1th and april 26th for a pneumonia related to SARS COV 2 and who had at least one echocardiography during their stay will be included. Analysis will be retrospective in order to report the hemodynamic profile with left ventricular and right ventricular function. Will be also reported the respiratory settings, the central venous presure if available as well as usual parameters of macrocirculation. All data will be reported in RedCap by the University of sydney (https://redcap.sydney.edu.au/).

Eligibility Criteria:
Inclusion Criteria: patients admitted in the ICU for pneumonia related to SARS COV2 and who had at least 1 critical care echocardiography during the first 28 days.

-

Exclusion Criteria: Patients who did not have any critical care echocardiography during the first 28 days of the ICU stay.
The Relationship Of Ultrasonographic Measurements With Sarcopenia in Stroke

introduction:The aim of this study was to show the relationship of distal femoral cartilage and quadriceps thicknesses with functional status and presence of sarcopenia in ambulatory stroke patients with voluntary movement.

Materials and Method: Forty-eight patients who were diagnosed with stroke due to cerebrovascular disease, had started voluntary movement, and had a motor recovery of 3 or above according to Brunnstrom's Staging were included in this cross-sectional study.

Forty-eight patients who were diagnosed with stroke due to cerebrovascular disease, had started voluntary movement, and had a motor recovery of 3 or above according to Brunnstrom's Staging were included in this cross-sectional study. Bilateral distal femoral cartilage thickness and quadriceps femoris (rectus femoris+vastus intermedius) thickness were measured by ultrasonography. In addition, A Simple Questionnaire to Rapidly Diagnose Sarcopenia (SARC-F questionnaire), hand grip strength, muscle mass measurement with Dual energy X-ray absorptiometry (DXA), short physical performance battery (KFPB) tests were performed and the presence of sarcopenia The European Working Group on Sarcopenia in Older People-2 (EWGSOP- 2) were evaluated according to the criteria. Patients' Functional Independence Scale (FIM), Functional Ambulation Scale (FAS), Barthel Index and modified ashworth scale (MAS) were evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Between 18 and 90 years old
* Presence of a history of ischemic or hemorrhagic stroke (based on CT and/or magnetic resonance imaging (MRI) report)
* Brunnstrom hemiplegia recovery staging, stage 3≥

Exclusion Criteria:

* History of recurrent cerebrovascular accident
* More than 2 years have passed since the history of cerebrovascular accident
* Inflammatory arthritis or any other rheumatic disease
* History of trauma to the knee (cruciate ligament or meniscus trauma)
* Previous knee surgery
* Pre-stroke neurological gait disorder
* Lower extremity amputation
* Knee joint contracture
A Drug-Drug Interaction (DDI) Study of ADC189 With Itraconazole in Healthy, Adult Subjects

This study aims to answer how repeat doses of itraconazole impact the pharmacokinetics, safety, and tolerability of single doses of ADC189 in healthy adults.

Participants in this study will complete screening assessments within 14 days before the first dose of ADC189. Participants will be admitted to the clinical pharmacology center (CPC) and complete 2 periods of treatments. On Day 1 and 26, each participant will receive a single oral dose of ADC189 (45mg), under fasting condition On Day 22, all participants will receive oral doses of itraconazole 200 mg (bid), after meal. From Day 23 to Day 25, and Day 26-D39, participants will receive itraconazole 200 mg(qd). Blood and safety assessments will continue for 336-hours after dosing on Day 1 and Day 26. Participants will receive a telephone follow-up on D47 (±3) days for a final visit.


Eligibility Criteria:
Inclusion Criteria:

* Sign informed consent, be capable of and willing to comply with study restrictions and procedures.
* Healthy adult subjects aged 18 to 55 years.
* Weight \>=50kg for males, and \>=45kg for females, BMI 19-26 kg/m\^2.
* No clinical significance in physical examination, vital signs, laboratory examination, 12-lead electrocardiogram, abdominal ultrasound, and chest X-ray examination.

Exclusion Criteria:

* Subjects who participated in other drug trials within 3 months before screening
* Hospital admission or major surgery within 4 weeks prior to screening or a preplanned hospital admission during study participation
* Donated or lost ≥400 mL of blood in the previous 3 months before screening
* Have a history of allergic diseases (asthma, urticaria, eczema, etc.), or food allergies
* A history of drug abuse in the past five years
* Any condition or finding that in the Investigator's opinion would put the participant or study conduct at risk if the participant were to participate in the study
* Unable to complete this study for other reasons or the Investigator believes that he or she should be excluded