cyrilzakka/clinical-trials huggingface dataset:
Tramadol vs.Tramadol With Paracetamol

This study focused on to determine postoperative analgesic efficacy of tramadol compared to tramadol with addition of paracetamol after a lumbar disc surgery.

Background:

Despite developments in treatment of pain, the availability of new drugs or increased knowledge of pain management, postoperative pain control after different surgeries still remains inadequate.

Aims:

This study focused on to determine postoperative analgesic efficacy of tramadol compared to tramadol with addition of paracetamol after a lumbar disc surgery.

Study Design:

In this study we have randomized 60 patients into two treatment groups. In Group Tramadol patients received tramadol, In Group TramadolParacetamol patients received paracetamol 1 gr iv in addition to tramadol 30 minutes before the operation ends and 1 g at 6 hour intervals.

Methods:

Severity of the pain, total tramadol consumption, adverse effects, ramsay sedation scale score, nausea/vomiting scores, patient satisfaction score were recorded in the postoperative period.

Eligibility Criteria:
Inclusion Criteria:

American Society of Anesthesiologists (ASA) 1 or 2 status patients with single level lumbar disc herniation.

Exclusion Criteria:

Patients who could not use a patient controlled analgesia (PCA) device, known allergies to any of the drugs used in this study,hepatic and renal dysfunction, herniated disc with neurological deficit or intense pain justifying emergency surgery and the patients whose body mass index is ≥30 kg/m2 were excluded from the study.
The Effects of Intra-articular Injection of Mesenchymal Stem Cells in Knee Joint Osteoarthritis

Osteoarthritis of the knee is one of the most common causes of disability among elderly. As the disease progresses the cartilage become frustrated, surrounding bone react to become thicker and inflammation occurs in subchondral bone seen in T2-weighted MRI as increase in signal density. Patients are treated initially by pain management. In patients who don't response to first line treatment invasive treatment like total knee replacement is done. The investigators designed this clinical study with the aim of evaluating therapeutic effects of intra-articular injection of bone marrow mesenchymal stem cells (BM-MSCs) in patients with severe knee osteoarthritis.

This is single center, randomized, triple blind phase II clinical study. Patients will be divided into two groups of case and control. All subjects will undergo bone marrow aspiration. Mesenchymal stem cells will be isolated from bone marrow, cultured and transplanted back to the knee joint. Patients of case group will receive cell injection 1 and 4 months after bone marrow aspiration. Placebo will be administered in this group 6 months after the first injection. Patients of control group will receive placebo 1 and 4 months after bone marrow aspiration. They all receive cell injection 6 months after first placebo injection. Follow up visit will occur at 2 and 6 weeks, and 3 and 6 months after the first injection. Radiological exams will be performed before and 6 months after the first injection by MRI. Clinical quantitative assessment will measure joint function by the WOMAC index and pain by the visual analogue scale.

Eligibility Criteria:
Inclusion Criteria:

* Osteoarthritis diagnosed by MRI

Exclusion Criteria:

* Pregnancy or lactating
* Positive tests for HIV, HCV, HBV
* Active neurologic disorder
* End organ damage
* Uncontrolled endocrine disorder
Lifestyle Heart Trial

To assess long-term effects of a strict lifestyle change program on lipids, blood pressure, myocardial perfusion, and coronary atherosclerosis.

BACKGROUND:

The trial was the first randomized, controlled trial to determine whether patients outside a hospital could be motivated to make and sustain comprehensive lifestyle changes and whether coronary disease regression could occur as a result of lifestyle changes alone.

DESIGN NARRATIVE:

Patients were randomly assigned to an experimental group or to a usual-care group. Experimental-group patients were prescribed a lifestyle program including a low-fat vegetarian diet, moderate aerobic exercise, stress management training, stopping smoking, and group support. No animal products were allowed in the vegetarian diet except egg white and one cup per day of non-fat milk or yogurt. The diet contained approximately 10 percent of calories as fat. Control-group patients were not asked to make lifestyle changes. Coronary angiography was performed at baseline and at one year to assess progression or regression of disease. Patients were recruited into the trial between January 1986 and November 1988. The trial was supported prior to April 1989 from various sources other than the National Heart, Lung, and Blood Institute. Follow-up continued for four years.

The study completion date listed in this record was obtained from the Query/View/Report (QVR) System.

Eligibility Criteria:
Men and women, ages 35 to 75, with angiographically documented one, two, or three vessel coronary disease; no myocardial infarction during the preceeding six weeks; and not receiving streptokinase, alteplase, or lipid-lowering drugs.
Prevalence of Wild-type TTR Cardiac Amyloidosis in Patients With Polyneuropathy of Unknown Cause.

To investigate to what extent chronic axonal length-dependent polyneuropathy (CAP) and/or small-fiber neuropathy (SFN) is part of early non-cardiac manifestations of wild-type TTR cardiac amyloidosis (wtTTR-CA).

Consequently, explore whether this could ultimately lead to faster diagnosis and clinical outcome of wild-type TTR cardiac amyloidosis (wtTTR-CA).

Patients with chronic axonal length-dependent polyneuropathy (CAP) and/or small-fiber neuropathy (SFN) without well-defined cause will be recruited after a neurological standard routine work-up with NCS (Nerve conduction study) test, EMG, and Sudoscan®, previously performed at the neurology department of UZ-Brussel in normal clinical setting. All participants will be invited to the Neurology and Cardiology department for one visit on one day, for the following assessments:

Following exams will be performed:

* assessment of symptoms, severity, and duration of the polyneuropathy and the use of NTSS-6 and COMPASS31 score for mapping somatosensory and autonomic symptoms
* evaluation of objective polyneuropathy signs, using following scales: mPND, NIS
* Kansas City Cardiomyopathy Questionnaire (KCCQ)
* Electrocardiogram (ECG)
* Echocardiography

The following retrospective data from the medical file will be analyzed:

* assessment of medical history, medical treatment, and demographic data
* assessment of laboratory results (and, if applicable, other exams) extracted from the medical file and previously performed in the context of polyneuropathy workup
* assessment of previously performed NCV/EMG data and Sudoscan®, extracted from the medical file of the participants.

Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic axonal length-dependent polyneuropathy (CAP) and/or small-fiber neuropathy (SFN) without well-defined etiology.
* Age: \>= 60 years
* Male and female gender
* Written informed consent

Exclusion Criteria:

* Known cause of polyneuropathy
* Other types of peripheral neuropathy than chronic axonal length-dependent polyneuropathy (CAP) and/or small-fiber neuropathy (SFN).
* Patients younger than 60 years
Acute Defibrillation Performance of a Novel Can-less Shock Pathway

Evaluate the operation of the Implantable Subcutaneous String Defibrillator (ISSD) system in patients who require an Implantable Cardioverter Defibrillator (ICD) using an emulator.

The purpose of this study is to evaluate the operation, safety, and feasibility of the ISSD system in patients who require an ICD. An ISSD emulator will be briefly implanted and tested during the standard implantation procedure of an ICD, and then entirely removed.

The emulator is not a powered medical device.

This acute intra-operative protocol will test the ability of the ISSD to appropriately convert tachyarrhythmia.

Eligibility Criteria:
Inclusion Criteria:

* Subjects meeting class 1, 2a or 2b indication for ICD implantation
* Age \>18
* 32 \> Body Mass Index (BMI) \> 25
* 190 \> Height \> 165 cm
* 120 \> Waist size \> 90 cm

Exclusion Criteria:

* Any condition that precludes the subject's ability to comply with the study requirements, including completion of the study
* Female who is pregnant or breastfeeding;
* Female who is of childbearing age who does not use reliable contraception methods (e.g. contraceptive pills, Intra-Uterine Device, estrogen-containing plasters) or had a positive pregnancy test
* An acute infection requiring antibiotics two weeks prior to surgery
* Participation in any other investigational study in the time ICD implantation is planned, unless there is written consent from the study sponsor;
* Use of the antiarrhythmic drug Amiodarone (Cordarone, Sedacoron, Adenosine or other drugs) in the last 6 months before participation in the clinical trial;
* Existence of large permanent electrodes (e.g. epicardial electrodes), more than 3 permanent endocardial electrodes or any other metal object implanted in the upper part of your body;
* Any of the following cardiac diseases: protracted New York Heart Association (NYHA) class III or IV heart failure , Left Ventricular Ejection Fraction (LVEF) \< 20% or an enlarged or hypertrophied heart
* Pulmonary hypertension patient, either with a history of moderate or severe pulmonary hypertension or by estimated pulmonary pressure above 45 (by cardiac echo test).
* Chronic Obstructive Pulmonary Disease (COPD) patient that have been hospitalized in the last 12 months for COPD related reasons, require oxygen support or steroid based therapeutic support.
* Subjects with severely impaired kidney function as measured by a Cockcroft-Gault Glomerular Filtration Rate (GFR) with an estimated GFR ≤ 29.
* Subjects with prior abdominal surgery in the upper abdomen, previous upper abdominal trauma or anatomical deformities of the chest or upper abdomen
* Subjects with known bleeding diathesis.
A Virtual, Group-Based, Expressive Writing Intervention for Survivors of Adolescent and Young Adult Cancer

To learn more about the experiences of adolescent and young adult cancer survivors and investigate whether a group-based writing intervention can help to improve quality of life of adolescent and young adult cancer survivors.

Primary Objective:

To evaluate the feasibility of a virtual, group-based expressive writing intervention for survivors of adolescent and young adult cancer.

Secondary Objective:

To preliminarily assess the impact of the study for cancer survivors.

Eligibility Criteria:
Inclusion criteria:

* Age 15-39 years at cancer diagnosis
* Age 18-39 years at study entry
* Within 5 years of diagnosis of stage II-IV cancer
* Completed active treatment (participants receiving maintenance therapy remain eligible)
* No evidence of disease
* Can speak, read, and write in English.

Exclusion criteria:

* Nonmelanoma skin cancer
* Major mental health disorder (e.g., schizophrenia or bipolar disorder \[determined from patient records or self-disclosure\])
* No internet access.
Quantitation of Left Ventricular Ejection Fraction Change From Early Exercise Gated Stress/Rest Tc-99m CZT-SPECT MPI

The aim of this study is to evaluate early post-stress EF change (∆EF) and its relation to the severity of myocardial ischemia and angiographic coronary disease using CZT-SPECT MPI.

Single photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI) is a well-established noninvasive procedure for the evaluation and risk stratification of patients with coronary artery disease (CAD). However, it has been recognized that in certain patients SPECT MPI is unable to detect the presence of CAD or underestimates its extent. The fact that moderate to severe perfusion defects are noted in less than half of the patients with significant left main disease has stimulated studies to improve the diagnostic accuracy of SPECT MPI. These studies have analyzed post-stress parameters such as left ventricular (LV) ejection fraction (EF), wall motion abnormalities and transient LV dilation. However, these parameters were derived from data acquired using conventional Anger cameras as long as 60 minutes after stress tracer injection. Such delayed assessment may miss early ischemic stunning as a result of its rapid transient changes. However, with highly sensitive detectors and short lived tracers, the ability of PET MPI to measure EF during peak of stress has been reported. Similarly, the novel cadmium-zinc-telluride (CZT) SPECT cameras with solid state cardiac-focused detectors are significantly more sensitive than the conventional Anger scintillation cameras giving to SPECT the "PET-like" ability to image rapidly right after the stress test. The aim of this study is to evaluate early post-stress EF change (∆EF) and its relation to the severity of myocardial ischemia and angiographic coronary disease using CZT-SPECT MPI.

Eligibility Criteria:
Inclusion Criteria: the patients who will be able to complete exercise treadmill testing will be enrolled and analyzed.

-

Exclusion Criteria:

* severe aortic stenosis
* resting heart rate \> 130 beats/min
* significant atrial or ventricular arrhythmia
* sepsis
* fever
* hemodialysis
* pregnancy
Correlation Between the Cobb's Angle and the Forward Head Posture in Patients With Adolescent Idiopathic Scoliosis

Purpose of This study to detect if there is correlation between the Cobb's angle and the forward head posture in patients with Adolescent Idiopathic Scoliosis.

And if there is correlation between the Cobb's angle and the cervical sagittal curve angle in AIS. And also if there is correlation between the Cobb's angle and deep flexors muscles endurance in AIS

The prevalence of sagittal profile imbalance in adolescent idiopathic scoliosis is not known exactly as little research is available in this context (Nasser et al., 2023) Thought based on previous studies that a forward head corrective exercise program combined with conventional rehabilitation improved three-dimensional scoliotic posture and functional status in patients with adolescent idiopathic scoliosis. (Alia Diab et al., 2012) Up to our knowledge there is no significant evidence that there is correlation between Craniovertebral angle (CVA) and idiopathic scoliosis by Cobb's angle.

So we need to make a simple assessment method of the severity of scoliosis and its impact on head position through a simpler method by observing the cervical curvature through photos for CVA, This can help to avoid unnecessary radiological examination. In addition, it also may help in paying the attention to the correction of cervical spines, head position and cervical muscles endurance during conservative treatment of scoliosis.

Also studying cervical sagittal alignment deformities will help in surgical operations to maintain or restore sagittal physiological curvature side by side with correction of coronal scoliosis angle in order to prevent adjacent segment degeneration after the fusion operation.

Eligibility Criteria:
Inclusion Criteria:

* 1- Patients with AIS. 2- Patient with forward head posture CVA less than 48 degress. (Fard et al .,2021) 3- Patients aged between 10 and 18 years, (Upasani et al., 2007). 4- Patients who underwent Posterioanterior (PA) and lateral X-ray radiography, and Cobb angle \>10°.(Nasser et al.,2023) 5- Patients with Lenke types (1 to 6). 6- No previous spine surgery ((Wang, et al., 2017).

Exclusion Criteria:

* 1- Patients with congenital scoliosis (including hemivertebrae, butterfly vertebrae, and failure of segmentation), (Shu-Man Han et al., 2022 and Nasser et al., 2023).

  2- Other developmental thoracic deformity (funnel chest etc.). 3- Scoliosis with definitive reasons (secondary to neurofibromatosis, Marfan syndrome, and syringomyelia).

  4- Patients with neurologic deficit or spondylolisthesis (Upasani et al., 2007).

  5- History of spinal trauma and infection, and metabolic bone disease.
Serologic Profile of SARS CoV2 in COVID-19 Patients With Systemic Diseases

An observational study aiming to assess the serological profile of SARS-Cov2 patients with systemic diseases such as systemic lupus erythematosus, Sjogren syndrome, sarcoidosis, inflammatory myopathies, Behçet's disease, Rheumatoid arthritis and Spondyloarthritis

The study is a prospective, observational, multicenter clinical trial to be conducted in the internal medicine, rheumatology and virology departments of Military Hospital of Tunis. After obtaining informed consent from the patient, the investigator will perform an inclusion visit made of a patient interview and performing blood sample to search for IgG and anti-SARS IgM CoV2.

Patients with IgM-like antibodies will have an RT-PCR test for active infection. If the study participants will be diagnosed with COVID-19 positive during the study period, the attending physician is entitled to decide on their management based on the severity of the clinical status.

Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years old
* One of the following conditions: systemic lupus, Sjögren's syndrome, rheumatoid arthritis, inflammatory myopathies, spondyloarthritis, sarcoidosis and Behçet's disease.
* Informed consent obtained and signed

Exclusion Criteria:

* Refusal to repeat blood sampling if the first one was badly performed
* Informed consent not obained
Prevalence of Deficiency of Vitamin D in Critically Ill Patients

Vitamin D has been shown to related to clinical outcomes in critically ill patients. The object of this study is to investigate the prevalence of Vitamin D deficiency in critically ill patients with various length of ICU stay .

Studies have revealed that the serum level of 25-hydroxyvitamin D, as known as calcidiol, is low in critically ill patients. The prevalence ranges from 26 to 82%. 25-hydroxyvitamin D deficiency is associated with longer ICU stay, higher medical cost and higher death rate in septic patients. 25-hydroxyvitamin D is a kind of hormone related to bone and mineral metabolism. Moreover, the receptors were found in almost all cells, and it is related to immune system, cytokine release, cellular proliferation and differentiation, angiogenesis, and muscular energy. The main source is skin metabolism triggered by sunshine and food consumption. It is subsequently converted to calcifediol in the liver and then calcitriol in the kidney (the active form). Its serum level is regulated by parathyroid hormone and serum calcium and phosphate. The critically ill patients are deprived of sunshine, suffered from poor nutrition support, impaired liver and kidney function, higher rate of consumption, and are under higher risk of deficiency. Nowadays, the studies about 25-hydroxyvitamin D in ICU patients were conducted mostly in Europe and America. There is no large-scale study in Taiwan or Asia. A randomized controlled study from Austria has shown large dose supply in patients with 25-hydroxyvitamin D deficiency could decrease the mortality.

The object of this multi-center study is to investigate the prevalence of 25-hydroxyvitamin D deficiency, the risk factors and the correlation with outcomes. The results could be a step-stone for future randomized controlled studies.

Eligibility Criteria:
Inclusion Criteria:

* All ICU patients

Exclusion Criteria:

* 1, Less than 20 years 2, BMI \< 18 kg/m\^2 3, Had large dose vit D within previous four weeks (over 3000 IU per day) 4, ICU admission within previous three months 5, Have disease affecting vit D level, calcium metabolism, bone metabolism such as parathyroid disease, Rickets, liver cirrhosis child C 6, Communication difficulty
Effects of Tongue Tamers as an Early Treatment of Anterior Open Bite

Anterior open bite (AOB) is a malocclusion that causes aesthetic, speech, feeding, and psychological concerns, emphasizing the significance of beginning treatment as soon as possible to correct the disorder. The main etiological determinants of AOB include finger-sucking, pacifiers, and oral habits; hence, it is vital to use interceptive treatments focused on correcting and increasing bite stability during childhood to avoid the need for advanced therapy


Eligibility Criteria:
Inclusion Criteria:

* male or female patients in early mixed dentition period with age range 7-9 years
* dental anterior open bite equal to or greater than 1 mm,
* class I malocclusion
* clinical signs of anterior tongue thrusting.

Exclusion Criteria:

* Patients with skeletal open bite
* posterior crossbite
* tooth agenesis or loss of permanent teeth
* crowding,
* systemic diseases
Body Responses to Bean Physical Form and "Beano"

The aim of this study is to determine the effects of bean physical form (whole versus blended) and Beano on postprandial responses. The postprandial responses the investigators will examine include blood glucose, appetite, metabolic rate, physical symptoms, and mood. To accomplish this aim the investigators will conduct a randomized, placebo-controlled trial in overweight and obese but otherwise healthy (non-diabetic) men and women


Eligibility Criteria:
Inclusion Criteria:

* Aged 18-55 years old
* Body mass index (BMI) 18.5-40 kg/m2
* Generally healthy
* A non-smoker
* Any ethnicity
* Free of chronic diseases and not taking medications or dietary supplements known to affect energy regulation or appetite

Exclusion Criteria:

* Beano drug label warnings including galactosemia, severe liver or kidney disease, allergies or sensitivities to any of the ingredients in Beano
* Peri and postmenopausal women
* Pregnant or lactating women (currently and within the past 1 year)
* Currently dieting or consuming unusual or a medically prescribed diet
* Net weight loss or gain (\>5 lbs) within the last six months
* Consuming 1/2c per day or more of legumes, not including peanuts
* Having taken Beano any time in the past 3 months
* Extreme problems digesting beans
* Fasting glucose \>126 mg/dl
* Blood pressure \>140/90 mmHg
* Moderate intensity or higher intensity exercise \> 6 h/wk
* Predicted energy requirement \< 2000 kcal/d or \>4000 kcal/d
Doxycycline for Lateral Epicondylalgia - RCT

Matrix metalloproteinases are involved in the pathogenesis of tendinopathy. Doxycycline, a widely available pharmaceutical agent mostly used for its antibiotic properties, also functions as an inhibitor of MMPs.

This study aims to investigate the effect of doxycycline treatment on lateral epicondylalgia (tennis elbow). During three weeks, patients receive doxycycline tablets 100 mg twice daily, or placebo. Main outcome variable is pain (VAS) at three weeks.

Serum and/or plasma levels of matrix metalloproteinases and tissue inhibitors of metalloproteinases are measured.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-65
* Pain at the lateral side of the elbow ≥8 weeks
* Local tenderness on palpation of the lateral epicondyle
* Pain on resisted extension of the wrist

Exclusion Criteria:

* Rheumatic disorder
* History of fibromyalgia or generalised pain
* Elbow surgery (on the painful side)
* Active infection
* Glucocorticoid treatment during the duration of symtoms of epicondylalgia
* NSAID use within 1 w before presentation and during the study
* Pregnancy
* Taking drug that might interact with doxycycline
Impact of Dental Desensitization Facilitated by a Child Life Specialist Distress and Cooperation

The aim of this study is to evaluate whether dental desensitization visits facilitated by a Certified Child Life Specialist (CCLS) significantly impact pediatric patients' distress and cooperation levels from the start of desensitization visit(s) to end of the desensitization visit(s), end of desensitization visit to start of subsequent hygiene appointment, and end of hygiene appointment.


Eligibility Criteria:
Inclusion Criteria:

* Patients and parents of patients aged 2-25 years who have been referred to the desensitization clinic.
* Patients who meet with a CCLS for dental desensitization.

Exclusion Criteria:

* Patients younger than 2 years old and older than 25 years old.