cyrilzakka/clinical-trials huggingface dataset:
A Study of Cardiac Arrhythmia and ECG Changes in Children With Convulsions at Sohag University Hospital

Convulsion is a common pediatric disorder and there is strong relation between convulsion and cardiovascular system which revealed by ECG monitoring and there are many ECG abnormalities attributed to different causes of convulsions, A 12-lead ECG is a low-cost test and can detect clinically significant abnormalities such as long QTc interval or heart block. Doing an ECG in all patients presenting with seizures clinic, inevitably, pick up non-specific abnormalities which require further investigation. Moreover, a normal 12-lead ECG does not exclude a cardiovascular cause for collapse and for those in whom a cardiac cause is still suspected despite a normal ECG, referral to a cardiologist is advisable


Eligibility Criteria:
Inclusion Criteria:

* All children aged from 1month to 18 years presenting to the Pediatric Emergency with convulsions will be included.

Exclusion Criteria:

* Children not filling the criteria of convulsions (like conditions mimic epilepsy)
* Children with known cardiac disease or cardiac arrhythmia and patients who will not give consent will be excluded.
Towards Understanding the Relationship Between Meals and Blood Biomarkers

The purpose of this study is to establish the reasonableness of using food-based photo diaries and continuous glucose monitors (CGM) to engage in counterfactual thinking strategies. These strategies may improve food choices among participants diagnosed with prediabetes (intervention group).

The long-term objective of this project is to create a counterfactual-based lifestyle intervention that curtails the progression of prediabetes to T2DM through management and knowledge of food choices. This is a significant objective since 70% of prediabetes patients go on to develop T2DM. The project addresses a major objective of PATHS-UP in general and Thrust 4 in particular, by developing an innovative behavior-change intervention that will eventually make use of information from the Lab-on-your-Wrist device. To our knowledge, this is the first project to (1) propose an intervention based on counterfactual thinking for diabetes prevention and (2) combine continuous glucose monitors (CGMs) and food photography to promote a better understanding of how food choices affect blood glucose.The specific aim of this project is to establish the validity of leveraging photo-based food diaries and CGMs to engage counterfactual thinking strategies that improve food choices amongst prediabetes participants. This will be measured by changes in (1) eating attitudes and behaviors, (2) behavioral intentions to improve healthy eating behavior, (3) motivation to improve eating behavior, (4) increased self- efficacy for healthy eating, and (5) number of glucose excursions and time-in-range.

Eligibility Criteria:
Inclusion Criteria:

* Ability to walk, sit down and stand up independently
* Family history of type 2 diabetes
* Overweight/obese status (BMI\>= 25)
* Subject is judged to be in satisfactory health based on medical history, physical examination
* Willingness and ability to comply with the protocol
* HbA1C levels are within the pre-diabetic range (5.7-6.4%) or fasting plasma glucose 100-125 mg/dL
* Access to a smartphone device and willing to use WhatsApp to communicate with research personnel

Exclusion Criteria:

* Subject has planned elective surgery requiring 2 or more days of hospitalization during the entire study
* Planned medical procedures that are documented to interfere with CGM readings, such as:

  * Xylose absorption testing (oral sugar testing)
  * CT
  * MRI
  * X-ray
  * Diathermy treatment (high-frequency electric current to stimulate heat generation within body tissues)
* Established diagnosis of malignancy
* Presence of acute illness or metabolically unstable chronic illness
* Any other condition according to the PI, nurse, or study coordinator that was found during the screening visit, that would interfere with the study or safety of the patient
* Failure to give informed consent or Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
Effect of Eplerenone in Elderly Hypertensive Early Stage Chronic Kidney Disease (CKD) Patients

The purpose of this study is to determine whether eplerenone is effective in the treatment of blood pressure, heart function, renal function in elderly hypertensive stage1 (eGFR\>=90ml/min/1.73m2) and stage2 (eGFR 60-89ml/min/1.73m2) chronic kidney disease (CKD) patients.

Chronic kidney disease (CKD) was reported to be affecting 11% of the all population. This number is much higher in the elderly population and may be as high as 30%. CKD is an independent risk factor of cardiovascular disease (CVD). This is called "Cardio-renal Continuum". The renin-angiotensin-aldosterone system (RAS) plays pivotal roles in both cardiovascular and renal functions.

The increased oxidative stress by activated RAS on vascular endothelium is one of important factor to development of Cardio-renal Continuum. The blockade of RAS by angiotensin I converting enzyme inhibitors (ACEIs) and/or angiotensin receptor blockers (ARBs) has been reported to ameliorate the renal disease and CVD; however,they do not completely suppress RAS and may induce aldosterone breakthrough that plays important roles for the development of CVD. Eplerenone, a selective aldosterone blocker, is effective against essential hypertension; however, little is known about the effects of eplerenone on heart and kidney functions in elderly hypertensive CKD patients. In this study, we assessed the efficacy of eplerenone on heart and kidney functions in elderly hypertensive early stage (stage1 (eGFR\>=90ml/min/1.73m2) and stage2 (eGFR 60-89ml/min/1.73m2)) CKD patients.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of stage1(eGFR\>=90ml/min/1.73m2) and stage2 (eGFR 60- 89ml/min/1.73m2)chronic kidney disease
* Clinical diagnosis of Hypertension (Blood pressure \>=140/90mmHg)
* Elderly people(\>=65 years old)

Exclusion Criteria:

* The patients who are already taking eplerenone
* Stage3(eGFR 30-60 ml/min/1.73m2),stage4(eGFR 15-30 ml/min/1.73m2)and stage5 (eGFR \<15 ml/min/1.73m2) CKD patients
* The patients who are receiving hemodialysis or peritoneal dialysis
* The patients who are taking itraconazole, ritonavir and nelfinavir
* The patients who are taking potassium-sparing diuretics and potassium supplement
* The patients who have hyperkalemia(\>=5.5mEq/ml)
* Severe heart failure (\>=NYHA class III)
* Insulin dependent diabetic mellitus or poor controlled insulin independent diabetic mellitus (\>=HbA1c 9.0\&)
* Severe liver dysfunction (five folds increased AST or ALT than standard values)
Modified Enhanced Recovery Program in Emergency Surgery (MERES)

Laparoscopic appendectomy (LA) is a widespread surgical procedure. Patients may develop considerable postoperative pain and dyspepsia resulting in prolong in-hospital stay. Almost 10% of patients develop postoperative complications. Enhanced recovery after surgery (ERAS) program has proven its effectiveness in elective surgery and can theoretically improve outcomes of LA. To date there is no ERAS program for LA. The aim of the study was to investigate the safety and efficacy of a modified ERAS protocol in LA.

A modified ERAS (mERAS) protocol was investigated. The study is a prospective, randomized nonblinded. All patients underwent LA. Modified ERAS protocol included patient informing, limitation of drainage use; intraperitoneal anesthesia with long-acting anesthetics; low-pressure pneumoperitoneum; early mobilization and oral nutrition. Pain level was assessed in rest using visual analogue scale (VAS). The primary endpoint was postoperative length of stay (pLOS).

Eligibility Criteria:
Inclusion Criteria:

* Patients with any stage of acute appendicitis except 3B according to Gomes classification;
* Class I-II surgical patients according to the classification of The American Society of Anesthesiologists (ASA).

Exclusion Criteria:

* Patient refusal to participate in the study or to sign the informed consent form;
* Language barrier;
* Transfer to the intensive care unit (ICU) after surgery;
* ASA class ≥ III;
* Conversion to open procedure;
* Appendicular mass found during laparoscopy;
* Gomes 3B appendicitis requiring immersion of the appendicular stump;
* Pregnancy.
A Study of ALXN1840 (Coated and Non-coated) Administered With And Without Omeprazole In Healthy Adults

This was single-center, open-label, randomized, 3-period, 3-treatment, 6-sequence crossover study evaluating the PK of single doses of WTX101 in healthy participants based on the measurement of plasma total Mo concentration.


Eligibility Criteria:
Inclusion Criteria:

* Non-smoker
* Medically healthy with no clinically significant laboratory profiles, vital signs, or electrocardiograms.
* Body mass index ≥ 18 and ≤ 32.0 kilograms/meter squared.
* Willing and able to adhere to contraception requirements.

Exclusion Criteria:

* Participant was mentally or legally incapacitated
* History or presence of clinically significant medical or psychiatric condition or disease.
* History of any illness that might have interfered with drug absorption.
* History or presence of hypersensitivity or idiosyncratic reaction to the study medications, study medication excipients.
* History or presence of alcoholism or drug abuse.
* Female participants who were pregnant or lactating.
* Positive results at screening for human immunodeficiency virus, hepatitis B surface antigen, or hepatitis C virus.
* Serum ceruloplasmin and copper values outside of the normal range at screening.
* On a diet incompatible with the on-study diet within the 28 days prior to the first ALXN1840 dose and throughout the study; unable to consume the contents of a high-fat breakfast.
* Participation in a previous clinical trial with ALXN1840.
Physiotherapy in Hereditary Spastic Paraplegia

Goal of this study is to develop and evaluate a physiotherapy concept that is focused on bilateral leg spasticity and aims to reduce spastic gait disturbance and to improve mobility in patients suffering from HSP.

This is a randomized single-center parallel study with a control group design. A blinded block randomization in groups of four was performed in equal parts toward the treatment (TPC) or the control (regular standard-of-care) group using randomization.com. Group assignment was kept in a closed envelope which was opened by the participant at the end of the baseline visit. Therefore both, the movement disorder specialist as well as the physiotherapist, were blinded to the randomization result for the baseline assessment up to the beginning of the first physiotherapy training session.

Therapeutic effects were evaluated at follow-up visits after 12 weeks (first visit, short-term effect) and after 26 weeks (second visit, long-term effect) comparing standard-of care with the TPC. Clinical evaluation is stated in detail below. Primary outcome assessment of this study was the change between baseline and follow-up assessment in treatment to control group in the spastic paraplegia rating scale (SPRS) score as a validated measure of disease severity (see Reference). Secondary outcome assessment was the change in walking distance in the Three-Minute-Walking test (3MW). Further exploratory outcome assessments were evaluated as effect sizes as specified below.

Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of hereditary spastic paraplegia
* manifest spastic gait disturbance
* remaining walking ability of at least 100m in three minutes,
* no botulinum toxin treatment during the entire study and three months prior to study inclusion
* no functional electronic stimulation during the study period.

Exclusion Criteria:

* see above
A Trial on Supervised Primaquine Use in Ethiopia

This is a randomized, controlled, open label trial to assess the effectiveness of unsupervised versus supervised primaquine treatment in patients with uncomplicated malaria. In co-endemic regions, the risk of P. vivax relapse following treatment for P. falciparum is high. Hence patients infected with either P. vivax or P. falciparum will be included in the study. The study will be conducted in Ethiopia. Participants will be enrolled at health centres and provided with the recommended schizontocidal treatment plus primaquine radical cure which will be either supervised or unsupervised according to randomisation. Participants will be followed up for four months and assessed at regular intervals for the presence of patent and sub-patent malaria. The outcome of the study will contribute to an improved treatment scheme for uncomplicated malaria in this area.


Eligibility Criteria:
Inclusion Criteria:

* Fever (axillary temperature ≥37.5⁰C) or history of fever in preceding 48 hours
* Age \>5 years
* Weight \>5kg
* Written informed consent
* Living in the study area and willing to be followed for 4 months

Exclusion Criteria:

* General danger signs or symptoms of severe malaria (Appendix 17.1 and 17.2)
* Anaemia, defined as Hb \<8g/dl
* Pregnant women as determined by Urine β-HCG pregnancy test
* Breast feeding women
* Known hypersensitivity to any of the drugs given
* Living in the same household as an individual enrolled into the study in the last 14 days
Computed Tomography (CT) Score and Histopathology of the Middle Turbinate in Chronic Rhinosinusitis

In a previous study (Berger el al. Old and new aspects of middle turbinate histopathology. Otolaryngol Head Neck Surg. 2009;140:48-54), the investigators reported significant histopathologic changes in the middle turbinate mucosa of patients with chronic rhinosinusitis compared with normal controls. However, patients' mean Lund-MacKay CT score was 6.5±6.7 and were considered as having a relatively limited sinus disease (a score of 1-8). Nine to sixteen was considered as intermediate sinus disease, and 17-24 extensive. No osteomyelitic changes were seen in this study group.

The investigators hypothesize that a comparison between the three groups of patients with chronic rhinosinusitis having limited, intermediate, and extensive sinus disease would show that the higher the CT staging, the greater the histopathologic changes of the middle turbinate. The investigators also expect to find osteomyelitic changes in the middle turbinate of patients with higher CT staging.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with chronic rhinosinusitis who failed conservative medical treatment,
* Patients who stopped treatment (topical or systemic corticosteroids) at least two months before endoscopic sinus surgery.

Exclusion Criteria:

* Immunosuppressed patients,
* Patients in whom no indication to excise the middle turbinate was found, AND
* Patients in whom a pathologic evaluation of the middle turbinate was necessary (e.g., suspected neoplastic disorder).
Exoskeleton Neurogenic Bowel Dysfunction Study

The purpose of the study is to assess the effects of exoskeleton training on neurogenic bowel disorders in spinal cord injury/ disease.

After being informed about the study and the potential risks, all patients giving written consents will undergo a medical examination to ensure they are eligible and fit to proceed for the study. Subjects will be randomly assigned to intervention group and control group.

Intervention group will receive 2 consecutive courses of exoskeleton training (ET) with twelve 45-minute sessions, each to be completed in 6 to 8 weeks. The total period of training will be 12 to 16 weeks.

Control group will receive twelve 45-minute sessions of usual physiotherapy treatment (PT), consisting of maintenance exercise in the first 6 to 8 weeks, and then one course of ET with twelve 45-minute sessions in the following 6 to 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. SCI/D for a duration ≥ 12 months
2. Neurological level of injury (NLI) C4 to L3 as defined in the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) 2019 revision
3. Bowel opening via anal route or stoma
4. Stable medical condition
5. Stable mental condition
6. No active painful musculoskeletal problems like fracture, infection, pressure injury, contracture or uncontrolled spasticity
7. Age ≥ 18 years old
8. Body height 150 - 188cm

Exclusion Criteria:

1. Unstable cardiovascular or pulmonary conditions
2. Untreated thromboembolic events
3. Untreated psychiatric disorders
4. History of malignancy
5. Any contra-indications for exoskeleton training
Study on the Efficacy of Long-term Drainage of Subdural Effusion After Decompressive Craniectomy

Drilling or puncture drainage is commonly used in TBI patients with subdural effusion following decompressive craniectomy who fail to respond to conservative treatment, but there is no exact regulation or guideline recommendation for the drainage time. The investigators aimed to conduct a randomized controlled trial to evaluate the efficacy and safety of long-term versus short-term drainage in the treatment of subdural effusion after decompressive craniectomy in patients with traumatic brain injury.

Subdural effusion is a common complication following decompressive craniectomy for TBI (traumatic brain injury), with an overall incidence of 20%-50%. The clinical symptoms of subdural effusion are mainly related to the volume of effusion, and patients with a small volume of effusion may have no obvious symptoms. The flap bulge and tension of the decompression window can be seen on the same side of the decompressive craniectomy window. The specific clinical manifestations can include headache, dizziness, vomiting, epilepsy, hemiplegia, disturbance of consciousness, and other related symptoms. The degree of disturbance of consciousness changes, which can seriously affect the prognosis of patients. Drilling or puncture drainage is often used in patients with subdural effusion who fail to treat conservatively, but the drainage time has not been defined or recommended by guidelines. At present, short-term drainage is the main treatment, but there are problems such as difficulty completely absorbing the effusion or repeated recurrence. Long-term drainage can improve the absorption rate of effusion, but there is a risk of intracranial infection and other complications. Therefore, it is rarely used in clinical practice, and its clinical risks and benefits are not yet clear. Therefore, the investigators aimed to conduct a randomized controlled trial to evaluate the efficacy and safety of long-term drainage and short-term drainage in the treatment of subdural effusion after decompressive craniectomy in patients with traumatic brain injury.

Eligibility Criteria:
Inclusion Criteria:

1. Unilateral DC surgery was performed on TBI patients after injury;
2. Subdural effusion occurred for the first time and occurred within 30 days after DC surgery;
3. Unilateral effusion accumulation (can appear on the same or opposite side of the bone flap);
4. The subdural effusion cannot be absorbed or has no decreasing trend with conservative treatment and consistent with the indications for surgical treatment;
5. Sign the study informed consent;

Exclusion Criteria:

1. History of craniocerebral disease or craniocerebral surgery;
2. Patients with intracranial infection (cerebrospinal fluid test results must be confirmed by lumbar puncture before inclusion);
3. Combined with ventricular hydrocephalus;
4. Other factors lead to poor prognosis or affect the treatment plan of the patient, even if the effusion can be recovered well, but severe pre-existing disability or severe co-morbidity such as serious heart disease leads to poor prognosis or even death;
5. Pregnant female.
A Study on Efficacy and Safety of Topiramate OROS Controlled-Release in Obese, Type 2 Diabetic Subjects Managed With Diet or Metformin

The purpose of this study is to evaluate the effectiveness and safety of a topiramate controlled-release formulation in the treatment of obese, type 2 diabetic patients managed with diet alone or combined with metformin.

Topiramate is not approved for the treatment of obesity. Studies have shown that an immediate release formulation of topiramate reduces body weight in obese patients with or without type 2 diabetes. A novel controlled-release formulation of topiramate using OROS® technology has the potential for better efficacy and safety in the treatment of obesity. This double-blind, placebo controlled study will evaluate the effectiveness and safety of the controlled-release formulation in the treatment of obese subjects with type 2 diabetes. The study consists of 2 screening visits, a baseline visit, 7-week titration phase (topiramate dose will be increased from 25mg daily to 175mg daily), 9-week maintenance phase, 2-week taper phase and a 2-week follow-up. Effectiveness will be evaluated by the percent change in body weight, body mass index, and anthropometric measurements (waist and hip circumferences and their ratio). Safety evaluations (incidence and severity of adverse events, physical measurements and clinical laboratory tests) will be conducted throughout the study. The study hypothesis is that topiramate 175 mg daily, when administered as the OROS® controlled-release formulation, is effective (in terms of percent reduction in body weight from baseline to week 16) and safe, as compared with placebo, in the treatment of obese, type 2 diabetic patients managed with either diet alone or combined with metformin. During the titration phase, topiramate (in the OROS® controlled-release formulation) will be gradually increased to 175mg daily by mouth, and the dose will be maintained for 9 weeks, and then slowly discontinued over 2 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) \>= 27 kg/m\^2 and \<50 kg/m\^2
* Diagnosis of type 2 diabetes, managed with either diet alone or combined with monotherapy treatment with metformin
* Stable weight for at least 2 months
* Female patients must be postmenopausal for at least 1 year, surgically incapable of childbearing, practicing abstinence, or practicing an acceptable method of contraception (requires negative pregnancy test).

Exclusion Criteria:

* Contraindication or hypersensitivity to topiramate
* Exposure to any other experimental drug or device within past 90 days
* Established diagnosis of Type 1 diabetes
* History of severe or recurrent hypoglycemic episodes prior to study entry
* Taking oral antidiabetic medications other than metformin
* Treatment with insulin within 4 months
* Significant liver, kidney or cardiovascular diseases.
Autologous Cellular Therapy With PRP-PC in Chronic Lung Diseases: An Observational Study LI-004

For this study, cells will be harvested from the patient from the peripheral blood, isolated and concentrated using proprietary Emcyte™ equipment/centrifugation, and then returned to the patient same day via the peripheral circulation. As circulation occurs, the concentrated cells enter the right heart and are then disseminated into the lungs, becoming trapped in the lung's microcirculation. Here, the cells are believed to produce multiple bioactive factors such as cytokines and anti-inflammatory mediators. Several growth factors are released by activated platelets becoming honing cells for healing within the tissue. The exact long-term mechanism of action of PRP-PC in the lungs remains under investigation. Safety studies have proven that autologous treatment is incredibly safe, largely because of the minimal cell manipulation and the autologous nature of the cells. Prior observational studies in this are have shown strong safety profiles as well as strong efficacy in both COPD and ILD.

Study Objective(s) Primary

* To determine if pulmonary function improves following ceullar therapy Secondary
* To determine if participants' perceived quality of life related to breathing improves following cellular therapy To evaluate the safety of autologous PRP-PC administration for chronic lung disease

Eligibility Criteria:
Inclusion Criteria:

1. Subjects age 18 and older
2. Diagnosis of COPD or an interstitial lung disease

Exclusion Criteria:

Pregnant subjects, subjects with an active cancer diagnosis except for basal cell skin cancer-