cyrilzakka/clinical-trials huggingface dataset:
The Effectiveness of Paracetamol Versus Ibuprofen in Management of Patent Ductus Arteriosus in Preterm Neonates

This study aims to find and compare the effectiveness of paracetamol and ibuprofen in the closure of patent ductus arteriosus in preterm neonates.

The study is being conducted at Department of Nursery (special care baby unit) and Neonatal intensive care unit (NICU), KTH, Peshawar.

Neonates diagnosed with patent ductus arteriosus (PDA) in the Special care baby unit (SCBU) and Neonatal Intensive Care Unit (NICU) were enrolled in the study after obtaining ethical approval and informed consent from caretakers. The babies received routine care according to departmental policies. For PDA management, participants were randomly assigned to Group A, receiving oral paracetamol (Panadol, 15 mg/kg every 6 hours for 3 days), or Group B, receiving oral ibuprofen (Brufen, 10 mg/kg followed by 5 mg/kg after 24 and 48 hours). Paracetamol was defined as a selective COX-2 inhibitor, while ibuprofen was a non-selective COX inhibitor, both working by inhibiting prostaglandin synthesis. Procedures were supervised by a consultant pediatrician, with continuous patient monitoring. Treatment effectiveness, defined as complete PDA closure on echocardiography, was assessed at the end of the study.


Eligibility Criteria:
Inclusion Criteria:

* Neonates of gestational age more than 30 weeks and less than 37 weeks
* Neonates with birthweight of ≥1250g
* Neonates with postnatal age of 48-96 hours
* Neonates having one of the following echocardiographic criteria: a duct size \&gt; 2mm, a left atrium-to-aorta ratio \&gt;1.4, end diastolic reversal of blood flow in the aorta, or poor cardiac function in addition to clinical signs of patent ductus arteriosus

Exclusion Criteria:

* Gestational age less than 30 weeks and more than 37 weeks
* Presence of major congenital abnormalities
* Right-to-left ductal shunting
* Life-threatening infection
* Grade III or grade IV intraventricular hemorrhage
* Platelet count of \&lt;60000/mm3
* Hyperbilirubinemia requiring blood transfusion
* Persistent pulmonary hypertension
The Profile of Fatigue and Discomfort - Sicca Symptoms Inventory

Primary Sjögren's syndrome (pSS) is a chronic, systemic autoimmune disease characterized by disorders of the lacrimal and salivary glands. The disease can be seen in systemic involvement by affecting any organ. It may result in skin, lung and kidney involvement as well as symptoms such as vasculitis and neuropathy. Patients with PSS often report fatigue as an important symptom to manage. Fatigue, defined as an overwhelming feeling of fatigue, lack of energy, and exhaustion, is associated with poor health and functional impairment.

Fatigue is a common symptom of pSS. This symptom is the most important cause of loss of function in patients. It is thought that as a result of fatigue in pSS, decrease in mental health related to physical activity level and quality of life in patients, sleep problems, depression and loss of ability to work. Several mechanisms have been proposed to explain the occurrence of fatigue among sjogren patients, but its underlying physiological basis has not been adequately defined. Therefore, it is a complex, multifaceted and poorly understood symptom.

In population-based studies, approximately 20% of healthy adults report experiencing fatigue, and this rate rises to 60%-70% among patients with autoimmune disorders. Fatigue is the most common non-exocrine symptom in pSS, and the prevalence of fatigue disability among patients with pSS has been reported to be approximately 70%.

In order to evaluate fatigue in primary Sjögren's syndrome patients, questionnaires such as FACIT Fatigue Scale, Sjögren's Syndrome EULAR Patient Reporting Index, Fatigue Severity Scale, Fatigue Multidimensional Assessment Scale and Short Form-36, which are also used in many disease groups, are used. Although the importance of the effect of fatigue on pSS patients has been demonstrated in studies, most of the fatigue assessment questionnaires used are not pSS specific. For this reason, Bowman et al. They developed the Fatigue and Discomfort Profile - Sikka Symptoms Scale (PROFAD-SSI) to assess multidimensional fatigue in patients with pSS, considering disease symptoms. PROFAD-SSI is scored from 0 to 7 on an 8-point Likert scale. The 19-item scale evaluates patients in 8 different dimensions: somatic fatigue, mental fatigue, arthralgia, vascular dysfunction, oral dryness, ocular dryness, cutaneous and vaginal dryness.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with primary Sjögren's syndrome
* Patients between the ages of 18-65
* Being literate

Exclusion Criteria:

* Having cognitive disorders
* Having another rheumatological diseases
Motivational Interview Based Discharge Planning for Patients With Diabetic Foot Ulcers

To evaluate the effectiveness of a discharge planning using the strategy of motivational interviewing among patients with diabetic foot ulcers

The purpose of this study is to evaluate the effectiveness of a discharge planning using the strategy of motivational interviewing among patients with diabetic foot ulcers.

A randomized controlled trial design will be used. From August 2020 to July 2022, 132 patients hospitalized for diabetic foot ulcers will be recruited. They will be randomly assigned to either the experimental or the comparison group in the first year, and then they will be followed by one year. The control group will receive routine care; the experimental group will receive a discharge planning which use the strategy of motivational interviewing. The discharge planning will be provided individually at the following time points: before discharge, on post-discharge days 3, 7, 14, 21, 28, and then each month till one year. Outcome measures include diabetic foot ulcer self-care behaviors and self-efficacy, foot skin conditions, glycemic control (measured by HbA1C), the infection rate of foot, and the readmission rate. Data will be collected at baseline and at 1, 3, 6, and 12 months after discharge.

The generalized estimating equation (GEE) will be used to evaluate the effect of the intervention on the diabetic foot ulcer self-care behaviors and self-efficacy, foot skin conditions, and the effect on glycated hemoglobin value reduction. The log-rank test will be used to compare the infection rate of foot, and the readmission rate between two groups.

Eligibility Criteria:
Inclusion criteria DFU inpatient Could communicate with Mandarin or Taiwanese HbA1C value higher or equal to 7.5 % Wagner stage 1 or 2 foot ulcer. Exclusion criteria Cognitive impairment Communication problems Affected foot has been amputated Autoimmune disease Be unable to perform daily self-care activity Be cared by foreigner and no other family members live together Plan to move to a long-term care facility Unwilling to visit the outpatient clinic at the research setting C-reactive protein values are higher than 15 mg/dL
Role of Intraoperative Thymoglobulin in Decreasing Ischemia-Reperfusion Injury in Pediatric Heart Transplant Recipients

The restoration of normal blood flow following a period of ischemia may result in ischemia / reperfusion injury (I/RI), which is characterized by inflammation and oxidative damage to tissues. Varying degrees of I/RI occur upon reperfusion of a donor heart after cold storage. Medications containing antibodies against immune cells have been used for many years as powerful immunosuppressants. These medications, called polyclonal antibody preparations, are generally only used immediately following transplantation and/or to treat rejection. At our institution, one such antibody preparation (Thymoglobulin) is used in most pediatric heart transplant recipients for 3-5 days immediately after transplantation. Because standard immunosuppressive medications (called calcineurin inhibitors) are toxic to the kidneys, the use of Thymoglobulin allows us to delay the initiation of calcineurin inhibitors until the kidneys of completely recovered from the shock of the transplant surgery.

We hypothesize that Thymoglobulin may be beneficial in reducing the damage caused by I/RI. Thus, the present study seeks to evaluate the effectiveness of an intra-operative dose of Thymoglobulin (in addition to the standard doses post-operatively) at reducing the effects of I/RI. The study will be a double-bind placebo-controlled trial involving 20 subjects. Biologic markers for I/RI will be assessed at periodic intervals for six months post-transplantation. Subjects receiving intra-operative doses of Thymoglobulin will be compared to the controls in order to assess the effectiveness of intra-operative Thymoglobulin in ameliorating the effects of I/RI.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric population (ages 0-21 years)
* End-stage cardiac disease requiring heart transplantation
* Approval for listing by the UCLA Heart Transplant Committee

Exclusion Criteria:

* Prior documented Thymoglobulin allergy/adverse reaction
* History of or current diagnosis of lymphoma
* Documented lymphopenia
* Documented Thrombocytopenia
* Pregnancy
Oral Amantadine, IV Amantadine and Hemodynamic Response to Laryngoscopy

this study will be undertaken-to evaluate the effect of oral amantadine versus IV amantadine premedication on the hemodynamic response to laryngoscopy ,tracheal intubation and surgical incision and their effect on β-endorphins.

Direct laryngoscopy and passage of endotracheal tube through the larynx is a noxious stimulus, which can provoke untoward response in the cardiovascular, respiratory and other physiological systems .Amantadine is a non-competitive NMDA receptor antagonist, and compared to ketamine, it is well tolerated with fewer side effects (mainly dizziness, sedation, and dry mouth). Amantadine's formulation permits the oral route for drug delivery, as well as the IV route. The side-effects profile of amantadine via all routes seems not to be harmful in appropriate dosages.. Amantadine has been clinically used as an antiviral drug, for dementia, and in the treatment of Parkinson's disease and spasticity. It is a non-competitive NMDA receptor antagonist, and compared to ketamine, it is well tolerated with fewer side effects (mainly dizziness, sedation, and dry mouth). Amantadine's formulation permits the oral route for drug delivery, as well as the IV route. The side-effects profile of amantadine via all routes seems not to be harmful in appropriate dosages.

In the central nervous system, beta-endorphins bind mu-opioid receptors and exert their primary action at presynaptic nerve terminals. However, instead of inhibiting substance P, they exert their analgesic effect by inhibiting the release of GABA, an inhibitory neurotransmitter, resulting in excess production of dopamine.

this study will be undertaken-to evaluate the effect of oral amantadine versus IV amantadine premedication on the hemodynamic response to laryngoscopy ,tracheal intubation and surgical incision and their effect on β-endorphins.

Eligibility Criteria:
Inclusion Criteria:

* ASA I\&II
* the age range 20-55 years scheduled for elective back surgery(laminectomy, discectomy and spinal canal stenosis)

Exclusion Criteria:

* Patient refusal
* Patients with ASA score III (with chronic kidney, lungs, Gastrointestinal tract, liver, or cardiovascular diseases)
* Pregnant or breastfeeding women.
* Allergy to any of the study medications and taking medications that could significantly interact with amantadine (tramadol, atropine, antipsychotic medications)
* DM, thyroid disease any endocrine disease
* Suspected difficult intubation or intubation time more than 30 second.
Investigating the Specificity of Neural Correlates for Emotion Processing Deficits in Conduct Disorder and Autism Spectrum Disorders

This study is

1. to investigate the differential and shared neural underpinnings of facial emotion processing within Conduct disorder (CD) and Autism-Spectrum disorder (ASD) and
2. to investigate the interaction between deficits in emotion processing and dysfunctional cognitive control processes.

Differences in emotion processing and the underlying neural underpinnings of such differences will be assessed by means of functional magnetic resonance imaging (fMRI) without any contrast agent, combined with adapted emotion processing paradigms and eye tracking techniques.


Eligibility Criteria:
Inclusion Criteria:

* For all participants: age between 10 and 18 years and an intelligence quotient score of 70 or higher.
* For patient groups: confirmed clinical diagnoses according to Diagnostic and Statistical Manual (DSM)-5 of CD or ASD (depending on the group), without comorbid depression or anxiety psychological disorders.

Exclusion Criteria:

* For all participants: low intelligence (IQ\<70, as they might otherwise not fully understand what they are expected to do inside the scanner), insufficient German language skills or any contraindications for MRI (e.g. pregnancy, any non-removable metal within the subjects' body, claustrophobia).
* For patient groups: severe developmental disorders, comorbid depressive and/or anxiety disorders will also be excluded from the study since it was shown that these patients might have problems in attention allocation under emotional stimulation.
* For typically developing participants: suspicion of an undiagnosed clinical disorder
Low-dose Dual-energy CT for the Pre-surgical Planning of Patients With Progression of Scoliosis

The aim of the study is to evaluate the diagnostic accuracy of low-dose dual energy CT in the pre-surgical planning of patients with progression of scoliosis

CT imaging is the gold standard for assessing bone dysmorphism and vertebral morphometry during the pre-surgical planning of vertebral arthrodesis. It is necessary in the definition of the fixation points to avoid malposition of transpedicular screws and potential visceral, vascular or neurological damage.

It is known that multislice CT involves an increased radiation exposure for patients, while dual-energy CT uses a low-dose acquisition protocol and VEO reconstruction software.

The aim of the study is to evaluate the diagnostic accuracy of low-dose dual energy CT in the pre-surgical planning of patients with progression of scoliosis who are candidated for vertebral arthrodesis.

Eligibility Criteria:
Inclusion Criteria:

* patients with progression of scoliosis without vertebral arthrodesis
* patients able to maintain immobility for the duration of the exam
* patients from 5 to 20 years old

Exclusion Criteria:

* pregnancy
* vertebral arthrodesis
* patients unable to maintain immobility for the duration of the exam
* non-compliant patients
* obese patients
* patients younger than 5 years old or older than 20 years old
COLchicine Versus Ruxolitinib and Secukinumab in Open-label Prospective Randomized Trial in Patients With COVID-19

Patients with mild and severe coronavirus disease 2019 (COVID 19) will be randomized 3:1:1:3 into four groups: colchicine, ruxolitinib, secukinumab, and control groups. . Patients will be follow-up during 45 days after randomization. Change in clinical assessment score COVID 19 (CAS COVID 19) between baseline and 12th day will be evaluated as the primary endpoint. Risk of death or mechanical ventilation during 45 days after randomization will also be assessed


Eligibility Criteria:
Inclusion Criteria:

* Signed inform consent
* COVID 19 with the mild and severe course. The diagnosis could be made with positive polymerase chain reaction (PCR) (International Statistical Classification (ICD-10) code - U07.1) and/or virus pneumonia in computer tomography (ICD 10 code - U07.2)
* Lung exposure on CT more than 25%
* Sp02 without supportive oxygen ≤ 93%
* C-reactive protein \> 60 mg/l or elevation of C reactive protein 3 times in 8-14 days after first symptoms

Exclusion Criteria:

* pregnancy and breastfeeding
* hypersensitivity to colchicine
* hypersensitivity to ruxolitinib
* hypersensitivity to secukinumab
* Known liver failure
* Glomerular filtration rate \<20 ml/ min
* physician judgment that the patient will need mechanical ventilation in 24 hours
* QTc \> 450 ms
* other indications for to colchicine, ruxolitinib, and secukinumab
* Chronic therapy with corticosteroids or immunosuppressive therapy
* Active cancer
Evaluation of Supraclavicular, Suprascapular, and Interscalene Nerve Blocks for Outpatient Shoulder Surgery

The aim of this study is to assess analgesic efficacy of a supraclavicular nerve block, suprascapular nerve block, or interscalene nerve block in a population undergoing shoulder arthroscopy with rotator cuff repair. The investigators hypothesize that subjects from all three arms will receive equal analgesia since these blocks are routinely performed to treat post-operative pain after shoulder surgery.


Eligibility Criteria:
Inclusion Criteria:

* Unilateral total shoulder arthroscopy for rotator cuff surgery ASA physical status I-III, \>18 years old, Non-pregnant, Consent to participate in the study

Exclusion Criteria:

* Refusal to participate, \< 18 years old, Chronic opioid use, Localized infection, Pregnancy or lactating, Pre-existing coagulopathy, Allergy to ultrasound gel or local anesthetics, Diaphragmatic dysfunction
Randomized Trial of Tibial Nerve Stimulation Versus Pelvic Floor Exercises for Treatment of Overactive Bladder

Urinary incontinence is defined according to the International Continence Society as any involuntary loss of urine, which may bring several negative consequences on women's lives, and among incontinent women, about 50% have urinary incontinence, 30% mixed and 20% emergency.

The overactive bladder present in urge incontinence and mixed cause significant impacts on people's lives and has a prevalence of 16.5% in the US population.

Behavioral therapies, exercises the pelvic muscles and drugs are the main forms of treatment. Drug therapy using drugs which are not specific for the bladder and are associated with many unwanted systemic side effects.

The results obtained by researchers in several countries using conservative techniques in the treatment of patients with urinary incontinence are encouraging and this study aims to evaluate carefully and systematically the effectiveness of tibial stimulation technique.

Importantly, also, that conservative techniques have lower cost than the surgical treatment and have virtually no side effects as most of the drugs used in the pharmacological treatment of female urinary incontinence.

Goal

Development of instrumentation for home treatment of overactive bladder and urgency / mixed incontinence using tibial stimulation and pelvic floor exercises.

Secondary objectives

* Development of an innovative portable equipment, with domestic technology for home application of the posterior tibial nerve stimulation technique using the type SSP surface electrodes (Silver Spike Point).
* Comparison of the effectiveness of tibial stimulation techniques and pelvic floor exercises in the treatment of overactive bladder and urgency / mixed incontinence.

Design Randomized Clinical Trial

Sample Women over the age of 18, complaining of urinary incontinence Urgency or Mixed (with main urgency component), catered in Urogynecology Ambulatory of Hospital de Clinicas de Porto Alegre.

Eligibility Criteria:
Inclusion Criteria:

- Women with Urinary Incontinence of Urgency or Mixed older than 18 years

Exclusion Criteria:

* Presence Of vaginal or urinary infection
* Not understand or sign the informed consent
* Not understand or are unable to perform the proposed treatment
* Pregnancy or the postpartum period covering the period up to 6 months after delivery
* Women in previous use of chronically used drugs (antidepressants, diuretics, and others) that can evidently alter the urinary function.
* Stress Urinary Incontinence of pure or mixed incontinence with a predominance of Stress component neurogenic bladder
* Use of Botox® in the bladder or pelvic muscles in the last year
* Use Interstim® or Bion®
* Use pacemaker or implantable defibrillator
* Current use of TENS in the pelvic region, lower back or legs
* Previous use of percutaneous tibial stimulation
* Drug / experimental devices in the past 4 weeks,
* Participation in any clinical research involving or affecting the urinary or renal function in the last 4 weeks.
* Pelvic radiotherapy;
* Changes in sensibility Lower Limb;
Safety of FCM vs. Standard of Care in Treating Iron Deficiency Anemia in Heavy Uterine Bleeding and Post Partum Patients

The Objective of this study is to study the safety of FCM in patients with anemia caused by Heavy Uterine Bleeding and the Post Partum state.


Eligibility Criteria:
Inclusion Criteria:

* Female with iron deficiency anemia
* Hg \</= 11 g/dL

Exclusion Criteria:

* Previous participation in a FCM trial
* Known Hypersensitivity to FCM
* History of anemia other that anemia due to heavy uterine bleeding or the post partum state
* current history of GI bleeding
* Received IV Iron within the month prior
* Anticipated need for surgery
* Malignancy history
* AST or ALT greater than normal
* Received an investigational drug within 30 days of screening
* Pregnant or sexually active females who are not willing ot use an effective form of birth control
Effects of Etanercept on the Heart, Veins and Thickness of Certain Major Arteries In Ankylosing Spondylitis Patients

Study to assess whether etanercept therapy is able to increase flow-mediated vasodilatation in AS, and whether etanercept can modify the intima-media thickness (IMT) in these patients


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of AS, as defined by Modified New York Criteria for Ankylosing Spondylitis.
2. AS with active disease as defined by Bath Ankylosing Spondylitis Disease Activity Index (BASDAI, see Attachment 4) \>= 4 at screening visit.
3. Patients capable, in the opinion of the investigator, of complying with the treatment schedule and doses throughout the 52 weeks
4. Agreement by male subjects who are not surgically sterile and female subjects who are not surgically sterile or postmenopausal to use reliable methods of birth control for the duration of the study.
5. Ability to self-inject drug or have a designee who can do so.
6. Ability to store injectable test article at 2ºC to 8ºC.

Exclusion Criteria:

1. Pregnancy confirmed by test taken at screening in all women except those who were surgically sterile or at least 1 year postmenopausal. Sexually active women of childbearing potential participating in the study must use a medically acceptable form of contraception that needs to be continued for 15 days following discontinuation of the test article.
High Versus Normal Protein Diet in Polycystic Ovary Syndrome (PCOS)

The objective of this study is to assess the effects of a high protein (HP) and a normal protein diet (NP) on patients with polycystic ovary syndrome (PCOS) and body mass index (BMI)-matched controls in a sample of southern Brazilian women.

Patients will be randomized to receive high protein (30% protein, 40% carbohydrate, 30% lipid) or normal protein (15% protein, 55% carbohydrate, 30% lipid) during eight weeks.

The investigators hypothesis is that a different diet composition may have influences in changes of the main characteristics of PCOS, like hyperandrogenism and metabolic syndrome.


Eligibility Criteria:
Inclusion Criteria:

* women of reproductive age
* BMI ranging from 18.5 to 39.9 kg/m²

Exclusion Criteria:

* Use of any drugs known to interfere with hormone levels for at least 3 months before the study
* Women with known type 2 diabetes, liver or renal disease or thyroid dysfunction
* Other hyperandrogenic disorders than PCOS