cyrilzakka/clinical-trials huggingface dataset:
Fascia Iliaca Compartment Block Versus Quadratus Lumborum Block in Total Hip Arthroplasty

Patients undergoing total hip arthroplasty are randomly assigned to two groups (fascia iliaca compartement block \[FICB\] group or quadratus lumborum block \[QLB\] group). In the FICB group, ultrasound-guided suprainguinal FICB (30 ml of 0.375% ropivacaine with 75 µg of epinephrine) is performed on the ipsilateral surgical side at the end of surgery. In the QLB group, ultrasound-guided anterior QLB (30 ml of 0.375% ropivacaine with 75 µg of epinephrine) is done on the ipsilateral surgical side at the end of surgery. A standardized multimodal analgesic regimen is used for postoperative pain control. The total use of opioids including patient-controlled analgesia and rescue analgesics is compared in both groups for 24 hours after surgery. The amount of opioids used is compared by conversion to oral morphine equivalent dose. Pain score at rest and movement during postoperative 24 hours, time to first request for analgesics, the incidence of side effects, patient satisfaction for pain control at postoperative 24 hours, quality of recovery at postoperative 24 hours, time to discharge readiness, and hospital length of stay are compared.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients between the ages of 19 and 70 undergoing total hip arthroplasty under spinal anesthesia
* Be able to provide written consent to participate in clinical trials, understand the procedures of this clinical trial, and be able to properly fill out patient-reported questionnaires
* ASA physical status classification 1-2

Exclusion Criteria:

* ASA physical status classification 3-4
* Patients who are contraindicated to nerve blocks (hypersensitivity to local anesthetics, infection at the injection site, etc.)
* Patients with chronic pain and taking pain medications, antidepressants, and anticonvulsants
* Other major medical or psychiatric conditions that will affect response to treatment
* Refusal of intravenous patient-controlled analgesia
* Patients determined to be unsuitable for this clinical trial by the researchers
Healthy Children 2021 Study in Childcare Centers

In Portugal, 17.3% of children under 10 years old are overweight and 7.7% are obese. Research has shown the implementation of healthy lifestyle promotion programs and obesity prevention, however "best practices" are far from being defined. Also, the first five years of life are important for the executive functions development, namely memory, inhibition (including self-regulation) and flexibility, which includes creative thinking, thinking "outside of the box", important in problem solving. The importance of social and emotional dimensions, as well as physical health for the development of cognitive health is consensual, as sleep deprivation, low physical activity, unhealthy food may inhibit the proper development of executive functions.

This project aims to evaluate the effectiveness of a healthy lifestyle promotion program on emotional, social and cognitive development and eating habits, sleep and physical activity in children between 12 and 42 months of age.

A cluster randomised trial will be developed and 300 children, from 16 childcare centres will be invited to participate. Half of the childcare centres will be allocated to the control group and the other half to the intervention group. Data collection will occur before randomisation (at baseline) and after intervention. A feasibility study will be undertaken prior to the experimental study, in accordance with internationally accepted procedures.

The investigators intend to implement the concept that the development of executive functions requires the combination of healthy eating, physical activity and sleep.

The project will contribute with evidence-based to the cognitive, social and emotional development in children.


Eligibility Criteria:
Inclusion Criteria:

* Apparently healthy (with no pre-existing conditions) children aged 12-42 months at baseline.

Exclusion Criteria:

* Children with disability
Impact of Teeth Brushing in Ventilated COVID-19 Patients.

The aims of this study were:

1. Observation of dynamics in oral microbiota and its association with the incidence of HAIs and VAP in mechanically ventilated COVID-19 patients in an ICU setting
2. Evaluation of the incidence of HAIs and VAP and their association with oral bacteriobiota in mechanically ventilated COVID-19 patients in an ICU setting
3. Assessment of impact of different oral hygienic procedures on oral microbiota, the incidence of HAI and patients' safety in mechanically ventilated COVID-19 patients in an ICU setting approaches to oral care in an ICU setting

Intervention of oral hygienic procedures implemented in study:

Patients were divided into 2 groups depending on the oral care procedure:

1. Standard oral procedure (cleaning and moisturizing of oral cavity, suction of excess fluid)
2. Extended oral procedure (cleaning and moisturizing of oral cavity, teeth brushing, suction of excess fluid)


Eligibility Criteria:
Inclusion Criteria:

* SARS-CoV-2 infection confirmed by real-time reverse transcriptase-polymerase chain reaction (RT-PCR) assay of nasal and pharyngeal swabs upon hospital admission
* Signed consent to participate in the study
* Patients admitted to ICU
* Intubation due to COVID-19 related pneumonia and acute respiratory distress syndrome (ARDS) within 24 hours preceding study procedures

Exclusion Criteria:

* No consent to participate in the study
Rivaroxaban for Patients With Antiphospholipid Syndrome

Long-term anticoagulation is widely used for secondary thromboprophylaxis in the antiphospholipid syndrome (APS) due to the high risk of recurrent events. Currently anticoagulation with vitamin K antagonists (VKAs) is the standard of care but have unpredictable pharmacodynamic properties that requiere monitoring for dose adjustment. Rivaroxaban, an orally active direct factor Xa inhibitor, has been shown to be effective and safe compared with warfarin for the treatment of venous thromboembolism and non valvular atrial fibrillation in major RCTs. No studies had been published in APS.The aim of the study is to investigate the efficacy and safety of rivaroxaban in preventing recurrent thrombosis in patients with APS compared with acenocoumarol

This is a phase 3 randomized, multicenter, non-inferiority open-label RCT. 190 eligible APS patients with arterial or venous thrombotic history receiving acenocoumarol will be stratified according the presence of SLE and venous/arterial thrombotic history and randomized (1:1) either to continue vitamin K antagonists (standard of care, normalized ratio (INR) 2-3 or 2.5 to 3.5 in those with recurrent thrombotic episodes) or to switch to rivaroxaban (20 mg/day). The primary efficacy outcome is the development of any thrombotic event during the study period. Secondary efficacy outcomes include time to thrombosis, type of thrombosis (arterial or venous), overall causes of death, evaluation of a prognostic biomarker panel of recurrent thrombosis. The primary safety outcome will be major bleeding. Secondary safety outcomes include any adverse event and minor bleeding.

Eligibility Criteria:
Inclusion Criteria:

* Patients with thrombotic antiphsopholipd syndrome
* Treated with acenocumarol for a minimum period of 6 months
* Positivity for Lupus anticoagulant and/or anti-cardiolipin or anti-B2GPI antibodies IgG or IgM≥40

Exclusion Criteria:

* Major haemorrhage (cerebral or gastrointestinal) within the previous 6 months
* Neurosurgery within the previous 4 weeks
* Any surgery within the previous 10 days
* Active peptic ulcus
* ALT or GPT \>120 UI/mL non-lupus related in the previous 30 days
* Platelets \<30x10E9 in the previous 30 days
* Recent diagnosed malignancy
* Any criteria listed in the summary of the produt characterisitcs (SPC)
* Renal disease with a creatinine clearance \<30 mL/min or with a known uncontrolled renal disease
* Concomitant administration of drugs that could interfere with CYP3A4
Perturbation-Based Balance Training on Trunk Proprioception and Balance in Cerebral Palsy:

To investigate the effect of Perturbation-Based Balance Training on trunk proprioception and balance in hemiparetic cerebral palsy

Thirty-eight patients with hemiplegic cerebral palsy will participate in this study.

The patients will randomly be divided into two equal groups; the control group which received the selected physical therapy exercise program and the study group received the same exercise training program in addition to Perturbation-Based Balance Training, three times per week for three months. The evaluation methods are BIODEX, The Pediatric Balance Scale, baseline digital inclinometer.

Eligibility Criteria:
Inclusion Criteria:

* - Thirty-eight children hemiplegic cerebral palsy
* Age will range as (8:10) years old
* Spastic hemiplegic cerebral palsy
* Normal body mass index ranged from 1SD to -2SDaccording to BMI-for age Z score charts include an age and sex- specific BMI for children (WHO, 2007).
* Gross motor function classification system: level I\&II

Exclusion Criteria:

* • Difficulty to communicate or to understand program instructions

  * any other neurological deficits or orthopaedic abnormalities,
  * secondary musculoskeletal complication
  * vestibular problems
  * any mental impairment
Integrated Coping and Awareness Training

Integrated Coping and Awareness Therapy is a novel therapeutic intervention combining strategies to improve stress reactivity and increase meaningful coping, as well as a range of possible proximal (e.g. immune indices of stress reactivity, symptom severity) and distal measures (e.g. relapse, quality of life).

Schizophrenia is one of the most devastating disorders that often results in a lack of functional recovery. Current treatments focused on remediating symptoms have shown only small successes in a return to functioning despite evidence of a dysregulated stress response. There is a fundamental gap in understanding the impact of allostatic overload in persons with schizophrenia that the investigators theorize is associated with deficits in functioning and with an increased vulnerability and relapse risk. The long-term goal is to test an intervention aimed at improving stress reactivity. The objective in this application is to develop and test the feasibility of a novel therapeutic intervention combining strategies to improve stress reactivity and increase meaningful coping. The central hypothesis is that an intervention that improves stress reactivity as measured proximally by endocrine, immune, and autonomic indices will result in improved adaptive capacity, better role functioning, reduced risk of relapse, and decreased likelihood of disability for people in the early stages of schizophrenia.

The rationale for the proposed research is that stress reactivity may be a modifiable risk factor underlying functional deficits in schizophrenia. The intervention integrates two treatment approaches. The first is based on research showing that mindfulness meditation practice is associated with alterations in the neural processing of stressful events and targets adaptive responses to stress. The second focuses on providing a buffer against stress by using the self-generation of adaptive emotions with a positive psychology intervention, which is potentially associated with building protective social resources. These complimentary interventions provide a comprehensive synergistic approach for this population that could lead to more adaptive coping responses and create a buffer against stress.

Eligibility Criteria:
Inclusion Criteria:

* Current or past diagnosis of a schizophrenia spectrum disorder.
* Has been receiving treatment for psychosis or taking medication for psychosis for less than 5 years.

Exclusion Criteria:

* Has been hospitalized in the last 3 months.
* Currently practicing meditation
* Current dependence on alcohol or drugs.
* History of significant neurological disorder.
* History of serious head injury (i.e., loss of consciousness longer than 15 minutes, no neuropsychological sequelae, no cognitive rehabilitation treatment post head injury).
* Illiteracy.
* Sensory limitation including visual (e.g., blindness, glaucoma, vision uncorrectable to 20/40) or hearing (e.g. hearing loss) impairments.
Assessment of Efficacies of Cardiac Resynchronization Therapies (CRT-P/D) for Heart Failure Patients in China

The ADOPT study is a prospective, nested case-controlled and open label clinical trial. About 40 centers across China participate in this study with a planned 800 Chinese cases enrollment. All patients will receive optimal medical treatment. Patients who have successful CRT-P/D implant will be assigned to CRT group. According to the baseline evaluation, matched cases will be selected from the enrolled OPT(optimal medical treatment) alone group (Group for Selection). After successful match, the cases in Group for Selection enters into follow-up and become control group. The unmatched cases in the Group for Selection will be removed. If patients agree, after re-evaluation of the baseline situation, she or he may enter into Group for Selection again. Since patients know she/he already have a device implant and the examiners are aware of the grouping of the patients after seeing the incision scar and post-implant electrocardiogram, this study is open-label designed, however the executive committee will be kept blind when making event-adjudication. Prospectively defined primary end points for the study include combined all-cause mortality and hospitalizations. A variety of secondary end points will further define the efficacy and mechanism(s) of action of cardiac resynchronization in heart failure. The last date of the study shall be the day after 24 months of follow-up of the last enrolled patient. All cases collection complete in 2010 and study result will be reported in 2012.


Eligibility Criteria:
Inclusion Criteria:

Heart failure patients who must meet all criteria:1.ischemic or nonischemic cardiomyopathy;2.NYHA classes III-IV despite OPT;3.normal sinus rhythm;4.LVEF≤35%;5.LV end-diastolic diameter≥55mm;and 6.Wide QRS complex≥120ms.

Exclusion Criteria:

1.Potentially reversible forms of cardiomyopathy;2.Cardiac surgery, percutaneous coronary intervention, cardiomyoplasty, myocardial infarction, unstable or severe angina or stroke within 6 weeks before randomization;3.In-patients requiring continuous intravenous therapy for heart failure;4.Life expectancy\<1 year for disease unrelated to heart failure;5.Mechanical tricuspid valve;6.Anticipated problem with compliance;7.Participation in another trial;8.Age\<18 years old;9.Women who are pregnant or not using medically acceptable birth control.
The Hepatitis Delta International Network

Hepatitis delta is a major health problem, not only because of the severity of the disease, but also due to the lack of effective antiviral treatment. To improve the current therapeutic options, a better understanding of the pathophysiology is essential. Reliable research in this direction is only possible with large patient study groups. However, given the geographic distribution of hepatitis delta, larger patient cohorts would only be possible through multicenter collaboration.

The hepatitis international network cohort is a multicenter, observational study that will build up a research registry of HDV patients all over the world.

The aims of this project are:

i. Collect clinical information from hepatitis delta patients from multiple centers distributed worldwide in order to build up a large database that will enable and facilitate further research on chronic hepatitis delta.

ii. To better inform patients about their viral infection, present status and evolution of liver disease throughout time. To give them the tools needed to inform other peers and medical professionals about the significance and consequences of a chronic hepatitis delta infection.

iii. To allow the participating physicians to track course of the disease, therapies, signs and symptoms of the hepatitis delta patients included by their center.

Eligibility Criteria:
Inclusion Criteria:

• Positive HBs antigen and antiHDV for longer than 6 months.

Exclusion Criteria:

Absence of any cause of relevant liver disease other than HDV (i.e. hemochromatosis, autoimmune hepatitis, alcoholic or toxic liver disease, etc.)
Hematologic Ratios in Postoperative Acute Kidney Injury

Acute kidney injury (AKI) is a common complication after surgery for congenital heart disease and is associated with significant morbidity and mortality. To-date, no biomarker has been universally implemented for predicting AKI in neonates after cardiac surgery. In this study, the use of hematological ratios will be evaluated for predicting AKI and postoperative outcomes in this patient cohort.

In adults, hematological ratios which can be calculated from a routinely ordered complete blood count with differential, such as the neutrophil/lymphocyte ratio, have been demonstrated to be correlated with acute kidney injury (AKI) and other clinical outcomes after cardiovascular surgery. In this retrospective observational study, the association between hematological ratios (neutrophil/lymphocyte ratio, platelet/lymphocyte ratio, neutrophil/lymphocyte\*platelet ratio, monocyte/lymphocyte ratio, and plateletcrit) and postoperative AKI, morbidity (length of ICU stay, hospital stay, mechanical ventilation, vasoactive infusion-free days, etc.) and mortality will be evaluated in neonates who underwent cardiac surgery with cardiopulmonary bypass.

Eligibility Criteria:
Inclusion Criteria:

* Neonates (≤31 days) who underwent cardiac surgery with cardiopulmonary bypass for congenital heart disease.

Exclusion Criteria:

* Patients with missing relevant preoperative or postoperative data points
* Patients with previous palliation or reoperation,
* Thymus hypo/aplasia (DiGeorge Syndrome, Ataxia-telangiectasia, or Nezelof syndrome),
* Primary immunodeficiency,
* Episode of cardiac arrest within 1 week before surgery,
* Signs or history of preoperative renal impairment or AKI (KDIGO Stage ≥1 observed on preoperative labs),
* Hypothyroidism,
* Patients with a history of infection within a week prior to surgery or antibiotics administered within the first 3 days after surgery (except for postoperative antibiotics).
Intra-articular Betamethasone and the Hypothalamic-pituitary-adrenal Axis

To evaluate the effect of intra-articular corticosteroid injection (IACI) of depot preparation of betamethasone on the hypothalamic-pituitary-adrenal (HPA) axis, in patients with osteoarthritis of the knee

Consecutive patients attending the rheumatology or orthopedic clinic with osteoarthritic knee pain, not responding satisfactorily to medical or physical therapy were allocated to group-1 after consent and given IACI of 6 mg of betamethasone acetate/betamethasone sodium phosphate. Following completion of this part, consecutive age- and sex-matched patients were allocated to group-2 and given intra-articular injection of 60 mg of sodium hyaluronate. Just prior to the knee injection and 1, 2, 3, 4 and 8 weeks later, patients had 1 µg adrenocorticotropin hormone (ACTH) stimulation test. Secondary adrenal insufficiency (SAI) was defined as levels of less than 18 ng/ml or a rise of \< than 7 ng/ml of serum cortisol, 30 minutes following the ACTH stimulation test.

Eligibility Criteria:
Inclusion Criteria:

* Osteoarthritis of the knee

Exclusion Criteria:

* Had steroids in the last 3 months. Allergic to steroids
The Effect of Effervescent Alendronate on Bone Turnover

64 postmenopausal women are randomized to treatment with either effervescent and buffered alendronate or conventional alendronate -both 70mg weekly for 16 weeks to see if bone turnover is suppressed to the same extent as in the conventional formulation with the effervescent form.

Alendronate is mainstay in the treatment of osteoporosis but is often discontinued due to gastro-intestinal side-effects. These side effects are believed to be caused by a low gastric pH induced by the drug. Effervescent and buffered alendronate is a new formulation that increases gastric pH and thereby decreases risk of side effects but the clinical effect of the drug is not fully elucidated. In the present study 64 postmenopausal women with a bone mineral density T-score \< -1 are randomized 1:1 to open label treatment with effervescent and buffered alendronate or conventional alendronate 70 mg weekly for 16 weeks. The primary end-point is change in the bone resorption marker "carboxy-terminal collagen crosslinks" from baseline to 16 weeks. The decrease in the two groups is compared using non-inferiority statistics. Secondary end-points include change in the bone formation marker "propeptide of type 1 procollagen", rate of change in the two bone markers and occurence of side effects.

Eligibility Criteria:
Inclusion Criteria:

* 2 years since last menstrual bleeding
* Bone mineral density T-score \< -1 at either lumbar spine or hip
* CTx \> 0.42 µg/L

Exclusion Criteria:

* Ever treatment for osteoporosis
* Indication for teriparatide treatment
* Treatment with oral systemic glucocorticoids within last 12 months
* Rheumatoid arthritis
* Inflammatory bowel disease
* Untreated thyroid disease
* Primary hyperparathyroidism
* Diabetes mellitus
* eGFR \< 60 mL/min
* Cancer within last 2 years except basal cell carcinoma of the skin
* Hormone therapy
* Unstable liver disease
* Contraindications for alendronate
* Major gastrointestinal disease within 12 months (eg. esophagitis, ulcer, major surgery).
* Vitamin D \< 50nmol/L
Comparison of Effects Between Amlodipine and Hydrochlorothiazide in Combination With Losartan on 24-hr Central Blood Pressure in Hypertensive Patients

The purpose of this study is to investigate which combination therapy is more effective for improving the blood pressure (BP) and AM central SBP in hypertensive patients:Angiotensin II receptor blocker (ARB) plus calcium channel blocker (CCB) or ARB plus diuretics


Eligibility Criteria:
Inclusion Criteria:

* Hypertension patients not included exclusion criteria
* Mean seated SBP ≥140mmHg in patients with newly Diagnosed

Exclusion Criteria:

- msDBP≥110mmHg or ms SBP ≥ 180mmHg at the screening and randomization visit
Disulfiram for Cocaine-Alcohol Abuse - 3

The purpose of this study is to evaluate disulfiram for cocaine-alcohol abuse.


Eligibility Criteria:
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Development and Translation of Generator-Produced PET Tracer for Myocardial Perfusion Imaging-Dosimetry Group

This study is a single center, early phase 1 clinical imaging study designed to assess the dosimetry of 68Ga-Galmydar for PET/CT imaging.

The objective is to evaluate dosimetry, biodistribution, safety, and imaging characteristics following a single 68Ga-Galmydar injection in normal healthy volunteers. Healthy adult normal volunteers (n=8, 4 males; 4 females) will undergo whole-body imaging (dosimetry group).

Healthy adult normal volunteers (n=8, 4 males; 4 females) will receive a single intravenous Ga-68 Galmydar administration of 8 mCi ± 20% (6.4-9.6 mCi) with a mass of ≤ 10 µg followed by whole-body PET/CT imaging.

Eligibility Criteria:
Inclusion Criteria:

• Healthy men and women, 18-99 years of age and any race

Exclusion Criteria:

* Inability to receive and sign informed consent;
* Positive urine screen for drugs of abuse at screening or before dosing or over-the- counter drug use or herbal preparations within the 2-week period prior to enrollment;
* Participation in another research study with a study drug, including a diagnostic or therapeutic radiopharmaceutical, to be administered during this study or which was or will be administered within 10 hall-lives of the radiopharmaceutical.
* Severe claustrophobia;
* Pregnant or breastfeeding.
* Body mass index \< 18 kg/m2 or \> 40 kg/m2.