cyrilzakka/clinical-trials huggingface dataset:
Multi-modality Imaging & Immunophenotyping of COVID-19 Related Myocardial Injury

Cardiovascular involvement in coronavirus disease-2019 (COVID-19) encompasses a wide range of vascular and myocardial pathologies, including both acute and long-term sequelae. The MIIC-MI study aims to investigate mechanisms of cardiac injury in COVID-19 using multi-modality imaging and immunophenotyping to better understand the link with adverse patient outcomes.

Cardiovascular involvement in coronavirus disease-2019 (COVID-19) encompasses a wide range of vascular and myocardial pathologies, including both acute and long-term sequelae.

Cardiac Troponin elevation, a marker of acute myocardial injury, has been identified in up to 28% of hospitalized patients with coronavirus disease 2019 (COVID-19) and is associated with an increased mortality risk. However, the predominant aetiology of myocardial injury relating to COVID-19 remains unclear. The Troponin leak could either signify direct cardiac involvement in COVID-19 or serve as a non-specific marker of a severe systemic insult.

There have been numerous reports of acute myocarditis in patients with COVID-19. Other contributory mechanisms of cardiac Troponin elevation in patients with COVID-19 that are also driven by a proinflammatory state include acute myocardial infarction due to atherosclerotic plaque rupture (type 1) or demand ischemia (type 2), endothelial and microvascular dysfunction, immune-mediated activation of coagulation and fibrinolytic systems, and stress cardiomyopathy.

Longer-term effects of COVID-19 on the cardiovascular system are also unknown. Many individuals with post-acute sequalae of SARS-CoV-2 infection (or 'long COVID') have unexplained cardiac symptoms. Patients may also present with new-onset heart failure after COVID-19, which is not attributed to another cause.

We aim to identify patterns of myocardial injury in COVID-19 using non-invasive multi-modality cardiac imaging, paired with cytokine/chemokine testing, immunophenotyping of peripheral blood cells and coagulation profiles.

A better understanding of the mechanisms underlying the excess mortality risk attributable to myocardial injury in COVID-19 is needed and may help to improve patient care.

Eligibility Criteria:
Inclusion Criteria:

* Patients \>18 years old
* Confirmed COVID-19 infection AND Troponin I elevation \>99th percentile of upper reference limit OR new-onset heart failure OR unexplained cardiac symptoms
* Able to give written, informed consent

Exclusion Criteria:

* Women of child-bearing potential not using adequate contraception
* Contra-indication to MRI scanning
* Contrast allergy or contrast-nephropathy
* Chronic kidney disease (eGFR \<30 mL/min/1.73 m2)
* Previous myocardial infarction
* Uncontrolled atrial fibrillation
* Uncontrolled chronic inflammatory disease
* Severe lymphopenia (\<0.2 x109/L)
* Treatment with immunomodulatory therapies within the last month (excluding inhaled or topical steroid therapy)
* Any medical condition, in the opinion of the investigator, that prevents the participant from lying flat during scanning, or from participating in the study
Effect of Exercise With Low Intensity and Longer Duration Versus High Intensity Interval Training

The purpose of the study is to compare exercise at 70% of maximal heart rate were total energy expenditure is twice compared to interval training at 90- 95% of maximal heart rate. Since 70% of maximal heart rate is well above the minimum threshold for improvements in maximal oxygen uptake it should be suited to investigate the effect of duration.


Eligibility Criteria:
Inclusion Criteria:

* healthy non smoking men and woman, age 18-30

Exclusion Criteria:

* pathological findings measured by ekko/doppler, high cholesterol or high blood pressure
Drain or no Drain After Thyroid Surgery: a Randomized Clinical Trial at Mulago Hospital

Thyroidectomy is one of the most commonly performed operations in general surgery. Available data seem to suggest an association between no-drain usage and a shorter duration of hospital stay. Seung et al found that the (following thyroidectomy) time to discharge after thyroidectomy was significantly shorter in the no drain group compared to the drain group. Similar results were recorded in a study conducted by Davari et al. Hyoung et al reported the incidence of hematoma formation post- thyroidectomy to be varying between 0.3%-4.3%. Tahsin et al reported that post-thyroidectomy bleeding is as rare as 0.3%-1.0%. The fear of an hematoma enlarging and obstructing the airway and causing difficulty in breathing, prompts many surgeons to use drains routinely after any type of thyroid surgery. The main reason is to drain off a possible postoperative hemorrhage, which may compress the airway and produce respiratory fail

This study will be aimed at comparing the patient outcomes with drain and no-drain insertion methods after thyroidectomy in a resource limited setting.

Study population: All adult patients aged between 18 to 79 years who attended the endocrinology outpatient clinic and had been diagnosed with goiter.

Study Participants: All adult patients with goiters who were eligible for thyroidectomy Inclusion criteria: All adult patients aged between 18 to 79 years with a diagnosis of goiter who consented to participate in the study.

Exclusion criteria: The investigators excluded patients with goiter who had a history suggestive of bleeding tendencies, recurrent goiter, and thyroid cancer with fixation of the thyroid gland to surrounding structures and had uncontrolled co-morbidities such as diabetes mellitus (DM) and hypertension (HT).

Inserting a drain after goiter surgery and not inserting a drain is the intervention all participants receive the same treatment

Eligibility Criteria:
Inclusion Criteria:

* All adult patients aged between 18 to 79 years with a diagnosis of goiter who consented to participate in the study

Exclusion Criteria:

* We excluded patients with goiter who had a history suggestive of bleeding tendencies, recurrent goiter, and thyroid cancer with fixation of the thyroid gland to surrounding structures and had uncontrolled co-morbidities such as diabetes mellitus (DM) and hypertension (HT).
Prevalence of H. Pylori Gastritis in Sleeve Gastrectomy Specimens

This is a cross-sectional study looking for prevalence of H.Pylori related gastritis among patients underwent sleeve gastrectomy over five year study period. The study also looks for possible association with patients's characteristics. Also, compares its findings with similar regional and international studies.


Eligibility Criteria:
Inclusion Criteria:

* patients who underwent sleeve gastrectomy
* surgery was performed between January 2015 and October 2019

Exclusion Criteria:

* patients whose resected specimens were not examined histopathologically
Parametric Testing of Direct Physiological Effects of Transcutaneous Vagus Nerve Stimulation (tVNS) in Healthy Controls

The purpose of this study is to determine the feasibility and safety of Transcutaneous Vagus Nerve Stimulation (tVNS) in healthy controls. Tested in healthy subjects (HS) the physiological effects of tVNS at different stimulation parameters. The electrical stimulation variables will be pulse width, frequency, and current. This will be tested in a laboratory setting and will measure tVNS effects on heart rate, respiration rate, blood pressure, and perceived pain. This is a feasibility and small safety study.

Hypothesis: tVNS is feasible and safe


Eligibility Criteria:
Inclusion Criteria:

* Meets none of the Exclusion Criteria

Exclusion Criteria:

* History of seizures, depression, or pain conditions
* Taking any prescription medications (excluding contraceptives and statins)
* History of any ear trauma
* History of heart conditions
* Has a heart pacemaker or artificial valve
* Has a metal implant above the waste
* Is pregnant
* Alcohol Dependence
* Illicit drug use in past 6 months
* History of brain surgery or lesions
* History of loss of consciousness (\>15 min)
* Faint at the sight of blood
* Hospitalization or surgeries in past 6 months
Comparison of Flutter and PEP Mask on Chest Clearance, Dyspnea in Elderly Asthmatic Patients

This study will be a Randomized controlled and will be conducted in Allied Hospital, Faisalabad. The study will be completed within the duration of 10 months. Convenience sampling study technique will be used to collect the data. The sample size of 30 patients will be taken in this study to find the effect of flutter and PEP mask therapy on chest clearance and dyspnea. Patients will be allocated randomly in two groups and 15 patients in each group. Group A will get flutter device therapy. Group B will get PEP mask treatment. A regular follow up visits to department and a final assessment was made at the end of last week by using questionnaire and resulting improvement was shown in results after completion. Data will be analyzed on SPSS25.

This study will be a Randomized controlled and will be conducted in Allied Hospital, Faisalabad. The study will be completed within the duration of 10 months. Convenience sampling study technique will be used to collect the data. The sample size of 30 patients will be taken in this study to find the effect of flutter and PEP mask therapy on chest clearance and dyspnea. Patients will be allocated randomly in two groups and 15 patients in each group. Group A will get flutter device therapy. Group B will get PEP mask treatment. Treatment will be given to all the participants 3 sessionsin a week, or 2 weeks and post treatment evaluation will be done after every week. A regular follow up visits to department and a final assessment was made at the end of last week by using questionnaire and resulting improvement was shown in results after completion. Data will be analyzed on SPSS25.

Eligibility Criteria:
Inclusion Criteria:

* Clinical Diagnosis Of Asthma
* Both age above 40-60 years of age
* Both gender
* No previous surgery

Exclusion Criteria:

* Other pulmonary disease
* Neurological problems
* Rib fracture
Correlation Between Family Functioning and PSF

In the present study, the investigators investigate the effect of family functioning on PSF in neurologic stroke patients in the early stages of the disease by surveying the current status of post-stroke fatigue to provide theoretical support for clinical care.


Eligibility Criteria:
Inclusion Criteria:

* patients whose clinical manifestations met the diagnostic criteria for stroke and whose stroke was confirmed by imaging (cranial computed tomography or cranial magnetic resonance imaging)
* those with first-episode stroke and in a stable condition
* those who were conscious and able to cooperate with the investigation
* those who gave informed consent and volunteered to participate in the study

Exclusion Criteria:

* patients with severe aphasia
* those with severe cognitive impairment who were unable to cooperate with examinations or questionnaires
* those with malignant tumours
* those with degenerative diseases of the central nervous system, such as Parkinson's disease
* those who were unable to cooperate with the doctor in the examination for other reasons
* those with a previous history of mental illness
* those with other recent major stressful life events, such as divorce or death of a loved one
* those with pre-stroke fatigue (PrSF)
A Study of Treprostinil and a New Formulation of LY900014 in Healthy Japanese Participants

The aims of this study are to evaluate:

* The safety and tolerability of a single dose of treprostinil given subcutaneously (as an injection just under the skin)
* The pharmacokinetic profile (how the body absorbs, breaks down, and gets rid of) of a single subcutaneous dose of a new LY900014 formulation in healthy Japanese participants.

The study has two parts. Participants may only enroll in one part.


Eligibility Criteria:
Inclusion Criteria:

* Overtly healthy Japanese
* Body mass index (BMI) 18.5 - 25 kilograms per square meter (kg/m²)
* Fasting plasma glucose ≥71 milligrams per deciliter (mg/dL) (3.9 millimoles per liter \[mmol/L\]) and \<108 mg/dL (6.0 mmol/L) (Part B only)
* Have normal blood pressure, pulse rate, electrocardiogram (ECG), blood and urine laboratory test results that are acceptable for the study

Exclusion Criteria:

* Are currently enrolled in a clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study
* Have participated in a clinical trial involving an investigational product within the 30 days before study entry.
* Have previously completed or withdrawn from this study or any other study investigating treprostinil or LY900014, and have previously received the investigational product
* Have or used to have health problems or laboratory test results or ECG readings that, in the opinion of the doctor, could make it unsafe to participate, or could interfere with understanding the results of the study
Study of Glycerol Phenylbutyrate & Sodium Phenylbutyrate in Phenylbutyrate Naïve Patients With Urea Cycle Disorders (UCDs)

This is a randomized, controlled, open-label parallel arm study to assess the safety, tolerability, pharmacokinetics and ammonia control, of RAVICTI® as compared to Sodium phenylbutyrate (NaPBA) in urea cycle disorder subjects not currently or previously chronically treated with phenylacetic acid (phenylacetate; PAA) prodrugs. The study design will include: 1) Baseline Period; 2) Initial Treatment Period; 3) a RAVICTI only Transition Period 4) a RAVICTI only Maintenance Period; and 5) a RAVICTI only Safety Extension Period. The study will run for approximately 25 weeks.

Study acquired from Horizon in 2024.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent given by the subject or the subject's parent/legal guardian for those under 18 years of age or the age of consent by local regulation.
* Male and female subjects with a suspected or confirmed UCD diagnosis of any subtype, except n-acetylglutamate synthetase (NAGS) deficiency.
* Suspected diagnosis is defined as having experienced a hyperammonemic crisis (HAC) or a documented high ammonia of \>=100 µmol/L
* Confirmed diagnosis is determined via enzymatic, biochemical, or genetic testing.

  * Requires nitrogen-binding agents according to the judgment of the Investigator
  * Birth and older.
  * All females of childbearing potential and all sexually active males must agree to use an acceptable method of contraception from signing the informed consent throughout the study and for 30 days after the last dose of study drug. Acceptable forms of contraception are (oral, injected, implanted or transdermal), tubal ligation, intrauterine device, hysterectomy, vasectomy, or double barrier methods. Abstinence is an acceptable form of birth control, though appropriate contraception must be used if the subject becomes sexually active.

Exclusion Criteria:

* Subject has received chronic treatment with an oral phenylbutyrate (RAVICTI, NaPBA, Pheburane, or other) longer than 14 consecutive days within one year prior to enrollment.
* Temporary use of NaPBA for acute management of a hyperammonemic crisis in the past is acceptable.

  * Any concomitant illness (e.g., malabsorption or clinically significant liver or bowel disease) which would preclude the subject's safe participation, as judged by the Investigator.
  * Has undergone liver transplantation, including hepatocellular transplant.
  * Subjects on sodium benzoate (NaBz) at Baseline will be excluded if they are viewed by the Investigator as being unable to undergo NaBz transition to a PAA prodrug during the Initial Treatment Period.
  * Known hypersensitivity to phenylbutyric acid (PBA) or any excipients of the NaPBA/PBA formulations.
  * Pregnant or breast-feeding patients. Women of childbearing potential must have a pregnancy test performed at the Baseline Visit prior to the start of study drug.
Efficacy of Diathermy on Healing Power of Cesarean Section Scar

To compare the effects of electro-surgery on healing power as a primary outcome (from skin to the peritoneum. And volume of blood loss, incision time and postoperative surgical wound pain as secondary outcomes.

This is a prospective study is carried out at Ain Shams University Maternity Hospital, Obstetrics and Gynecology Department, Faculty of medicine in women undergoing CS through pfannentiel incisions.

All women will receive intravenous antibiotic prophylaxis according to the Ain Shams guideline, 1 g of cefazolin given at the time of incision.

Diathermy incisions will be carried out using monopolar blade pen electrode, set on cutting mode and delivering a 35 continuous current. Electrosurgical cutting will be performed without pressure or mechanical displacement.

'Bleeders' will be controlled by using diathermy, on coagulating mode, and will be applied to a hemostat on the vessels.

Incisions made by the scalpel will be done by the traditional method, with proper hemostasis by application of pressure to skin blood vessels and by ligating the subcutaneous bleeders.

After the operation and during the postoperative period, paracetamol (10mg/mL) 50-mL vial will be administered by i.v. infusion for analgesia on demand according to the patient's need with a 500-mg dose. And the wound will be sutured subcuticle by a prolene 3.0 sutures.

Eligibility Criteria:
Inclusion Criteria:

* Primi-section
* BMI (18-29) kg/m\^2.
* Age from (18-40).
* Women undergoing CS with Pfannenstiel incision.

Exclusion Criteria:

* Women with one of the following conditions:

Patients requiring midline incision or on anti-coagulant therapy

* Cardiac patients on pacemakers and patients with chronic diseases expected to affect wound healing, such as diabetes, liver diseases, chronic anemia and renal impairment
* Obese patients BMI (\>30) kg/m\^2.
Study of the Touch® Trapezo-metacarpal Prosthesis

Prospective observational study of implanted patients with a new orthopaedic implant: the Touch trapezo-metacarpal prosthesis

Prospective observational study of implanted patients with a new orthopaedic implant: the Touch double mobility trapezo-metacarpal prosthesis, 15 years follow up.

Eligibility Criteria:
Inclusion Criteria:

• Patients implanted with the Touch® prosthesis by one of the three investigating surgeons

Exclusion Criteria:

* Patient not in capacity to understand the study
* Patient not in capacity to consent to the study
Effects of Fairytales on Preschool Children With Attention Deficit Hyperactivity Disorder

Under traditional rehabilitation programs, investigate the additional effects of individualized fairytales on preschool children with Attention Deficit Hyperactivity Disorder with developmental delays.

Thirty preschool children with Attention Deficit Hyperactivity Disorder and developmental delays will be enrolled in regular traditional rehabilitation programs.

They will be randomized to the intervention group and control group. The participants in the intervention group will receive an additional 30 minutes per week for 12 sessions of individualized fairytales classes by a child and educational teacher for three months. The participants of both groups will continue to receive the traditional rehabilitation programs.

Therapeutic effects, including attention, cognitive function, vocabulary function, physical functional performance, and quality of life at baseline, will be evaluated after 12 weeks of treatment and three months after the treatment.

The evaluator will be blinded to the group's allocation during the whole course of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* preschool children with a diagnosis of Attention Deficit Hyperactivity Disorder and developmental delay, under regular traditional rehabilitation programs, intelligence quotient 70 or greater

Exclusion Criteria:

* age less than 3 or greater than 6 of children diagnosed with Attention Deficit Hyperactivity Disorder and developmental delay, under regular traditional rehabilitation programs, intelligence quotient below 70
A Study of the Use of Oral Posaconazole (POS) in the Treatment of Asymptomatic Chronic Chagas Disease (P05267)

This is a study to compare the efficacy of oral posaconazole to placebo for the treatment of asymptomatic Chagas disease. The primary hypothesis of the study is that posaconazole 400 mg twice daily improves therapeutic response compared to placebo in participants with a diagnosis of asymptomatic chronic Chagas disease.


Eligibility Criteria:
Inclusion Criteria:

- Must have a positive serology result for Trypanosoma cruzi on any 2 of 3 of the following tests: indirect immunofluorescence, indirect hemagglutination, or enzyme-linked immunoabsorbent assay (ELISA)

* Must have a positive qualitative polymerase chain reaction (PCR) for Trypanosoma cruzi
* Must have a normal 12-lead electrocardiogram (ECG)
* Must have a normal 2-D echocardiogram
* Must have no evidence of ventricular tachycardia on 24-hour Holter monitoring
* Female participants of childbearing age must be using a medically accepted method of birth control before beginning study drug treatment and must agree to continue its use during the study, or must have been surgically sterilized
* Female participants of childbearing potential must have a negative serum beta-human chorionic gonadotropin (hCG) pregnancy test at Screening and a negative urine pregnancy test at Baseline or within 72 hours before the start of study drug

Exclusion Criteria:

* Are breastfeeding, pregnant, or planning to become pregnant
* Body weight \<60 kg
* Have an immunodeficiency or are immunosuppressed
* History of megacolon with obstipation or megaesophagus with severe swallowing impairment.
* Have previously received treatment with benznidazole or nifurtimox
* Known allergy/sensitivity to azoles
* Has aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels greater than 2.5 times the upper limit of normal at Screening
* Has serum creatinine \>2.5 mg/dL or 200 micromoles at Screening
* Has a history of severe alcohol abuse within two years from Screening
* Is taking any of the prohibited medication
REaCT Integrated Consent Model to Compare Two Standard of Care Regimens

The Integrated Consent Model is being increasingly used internationally to improve patient care. In this feasibility study we will explore whether the model is feasible in practice; and whether it can be used to increase the number of physicians and patients who take part in clinical trials, and address the critical issue around the optimal febrile neutropenia prevention by randomizing eligible patients to either G-CSF or ciprofloxacin.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed primary breast cancer
* Planned TC chemotherapy
* ≥19 years of age
* Able to provide verbal consent
* Willing to complete a survey

Exclusion Criteria:

• Contraindication to either Ciprofloxacin or G-CSF