cyrilzakka/clinical-trials huggingface dataset:
"Outcomes of Tracheostomy Done for Patients Admitted in Anesthesia Intensive Care Units of Assiut University Hospital"

This study was undertaken to Identify the factors affecting the outcomes of tracheostomy done in ICU for patients subjected to prolonged intubation and ventilation and to suggest guidelines to control:

1. proper timing of tracheostomy
2. process of decannulation.

Tracheostomy is described as the creation of a stoma at the skin surface which leads into the trachea. From the first tracheostomy until about 1930, the operation was performed exclusively for laryngeal obstruction. Nowadays, due to the development of the care of critically ill patients in intensive care units (ICUs), there are other indications for the procedure including prolonged intubation and pulmonary toilet.

The initial management of patients in an intensive care unit involves a series of interventions that aim to stabilize and then optimize their physiological state. Mechanical ventilation (MV) is a commonly utilized intervention to support a patient's respiratory function. The second phase in ICU management focuses on weaning the patient from the artificial supportive mechanisms.

The principle role of tracheostomy in the ICU is to expedite the weaning process in patients requiring prolonged mechanical ventilation and those predicted to be at risk of pulmonary aspiration. Tracheostomy facilitates weaning primarily by allowing increased level of patient activity and mobility.

Tracheostomy protects the larynx and the upper airway from prolonged intubation which may lead to laryngotracheal stenosis. Patients with tracheostomies tend to have fewer days of mechanical ventilation because of the improvements in the respiratory physiology. This is especially in trauma patients. They have improved secretion clearance as suction is easy and less strength is required for expectoration. This may be linked to the lower incidence of pneumonia and respiratory infections seen, especially in trauma victims.

Patients with tracheostomy are less sedated and therefore able to move in bed. The patients may also be able to swallow, so may be started on oral feeding sooner and mouth care is easier compared with an endotracheal tube (ETT) tube.

Eligibility Criteria:
Inclusion Criteria:

* All patients who were admitted to the ICUs of the main Assiut University Hospital.
* mechanically ventilated and
* underwent tracheostomy during his/her stay in ICU.

Exclusion Criteria:

* Patients who were admitted to ICUs and didn't need tracheostomy during the period of admission in ICU or after discharge from ICU,
* Patients who died during admission in ICUs before being tracheostomized,
* Patients who died during admission in ICUs after being tracheostomized and the cause of death was not related to the tracheostomy procedure or care.
Role of Gait Analysis in Different Type of Dementia

Aim for the work is the studying of the existence and pattern of gait impairment in pre-dementia and dementia To examine the association between dual decline in gait and cognition

Dementia is a syndrome usually chronic,characterised by progressive global deterioration in intellect, including memory,learning,orientation,comprehension,judgment,gait, and balance

Gait and balance are the product of successful integration of various posture control mechanisms and locomotion.

There are two basic phases in the full cycle of the step Stance phase Swing phase Slow gait speeds are associated with both cognitive decline and greater risk of dementia So, our aim of this work is to study the existence and pattern of gait balance impairment in patients with different types of dementia and comparison with healthy elderly people.

Eligibility Criteria:
Inclusion Criteria:

* patients with pre-dementia,dementia, and dementia diagnosed according to The Vascular Behaviour and Cognitive Disorder (VASCOG) and on medication Criteria attending Assiut University neurology outpatient clinic and internal department

Exclusion Criteria:

* 1 history of clinic manfist cerebrovascular stroke 2 definitely laterization sign 3 severe cognitive imparment MOCA 4 Spinal or orthopaedic problems 5 long-term use or abuse of medication affect cognition or balance 6 clinical evidence of peripheral neuropathy
Valproate Efficacy in Cocaine-Bipolar Comorbidity

This proposal will test the efficacy of a promising pharmacological approach for the treatment of comorbid cocaine dependence and bipolar disorder. We propose a randomized, double blind, placebo controlled 12-week trial to test the efficacy of Divalproex sodium (Valproate) plus treatment as usual compared to placebo plus treatment as usual in decreasing cocaine use and stabilizing mood symptoms among patients with comorbid cocaine dependence and bipolar disorder. Treatment as usual includes the use of lithium carbonate for mood stabilization plus supportive psychosocial treatment.

Bipolar disorder has the highest rate of association with cocaine and other substance use disorders than any other major severe psychiatric syndrome. This comorbidity represents a major treatment challenge and is associated with severe disability, morbidity, and heightened risk for suicide.

The aims of this study are:

1. Examine the efficacy of valproate plus treatment as usual compared to placebo plus treatment as usual in decreasing cocaine use in patients with cocaine dependence and comorbid bipolar disorder.
2. Determine whether primary vs. secondary cocaine dependence, bipolar subtype (depressed vs. manic/mixed) and the presence of additional substance use disorders moderate the association between treatment and cocaine use outcome.
3. Assess the effects of medication compliance and mood symptoms as mediators of cocaine use outcome.

Eligibility Criteria:
Inclusion Criteria:

* Meet DSM-IV criteria for cocaine dependence and a concurrent bipolar disorder

Exclusion Criteria:

* Schizophrenia, schizoaffective, and any non-bipolar psychotic disorder, unipolar major depression, primary anxiety disorder, mental retardation, and signs of impaired cognitive functioning.
* Current DSM-IV criteria for dependence on substances other than cocaine, alcohol, cannabis, nicotine, or caffeine
* Neurological conditions including epilepsy, history of brain injury, encephalitis, or any organic brain syndrome or documented focally abnormal EEG
* Medical conditions including severe cardiac, liver, kidney, or liver disease.
* Pregnancy
* Inability or unwillingness to use contraceptive methods
* Any medical condition or other reason that in the opinion of the investigator would prevent the subject from completing the protocol.
Effectiveness of Periodontal Treatment for the Glycemic Conttrol of Type II Diabetes Mellitus

The project is intended to find out the effect of Periodontal treatment for the glycemic control of type II diabetes mellitus patients.


Eligibility Criteria:
Inclusion Criteria:

1. Patients having Diabetes Mellitus and diagnosed with Periodontitis for last six months.
2. Aged between 30-60 years.
3. Patients with HbA1C level 7-9.5%, measured within three months prior to present study.

Exclusion Criteria:

1. Patients with acute oral infection
2. Need for immediate tooth extractions
3. Severe Hypertension (\>180/110 mm Hg)
4. Edentulous Patients
5. Patients with Diabetic Nephropathy
6. Patients with Diabetic Retinopathy
Unilateral Secondary Breast Reconstruction Using a Muscle-sparing Pedicled Dorsal Flap After Breast Cancer

The use of pedicled dorsal flaps sparing the latissimus dorsi muscle (TDAP and MSLD flap) is a well-described reconstruction method in breast reconstruction after breast cancer. However, little data exists regarding patient satisfaction after this surgery. The main objective of this study was to evaluate patient satisfaction after unilateral total secondary breast reconstruction using a TDAP or MSLD flap.


Eligibility Criteria:
Inclusion Criteria:

* Breast reconstruction using a TDAP or MSLD flap between January 1, 2018 and December 31, 2022
* Major
* Non opposition
* Women with social security number

Exclusion Criteria:

* Bilateral reconstruction
* Partial reconstruction
* Immediate reconstruction
* Prophylactic reconstruction
* Women who did'nt have a breast cancer
* Women who don't finish their reconstruction
* Women who don't want participate
Dose-Ranging Study of Sofosbuvir in Combination With Pegylated Interferon and Ribavirin in Treatment Naïve GT 1 HCV Patients

Participants with genotype 1 HCV infection were randomized to 1 of 3 sofosbuvir doses (100 mg, 200 mg, or 400 mg) or matching placebo once daily based upon stratification for IL28B status (CC or CT/TT). Placebo tablets were administered to participants receiving 100 mg active sofosbuvir (3 placebo tablets) and 200 mg active sofosbuvir (2 placebo tablets) in order to maintain the study blind. Participants received sofosbuvir/matching placebo from Day 0 to 27. Participants also received treatment with PEG+RBV starting on Day 0 of the study which continued for 48 weeks. Participants were evaluated for sustained virologic response (SVR) for an additional 24 weeks following completion of study treatment.


Eligibility Criteria:
Inclusion Criteria:

* Treatment-naive males and females, 18-65 years of age
* Genotype 1 HCV infection
* Negative pregnancy test for females of childbearing age
* Females of childbearing age and males with female partners of childbearing age must use two forms of contraception during treatment and following the last dose of ribavirin in accordance with locally approved label for ribavirin

Exclusion Criteria:

* Hepatitis B or HIV infection
* Pregnant or breast feeding females or male partners of pregnant females
* Previous interferon or ribavirin-based therapy or investigational anti-HCV agent
* History or evidence of medical condition associated with chronic liver disease other than HCV
Host-pathogen Interactions in Meningococcal Disease: Finding the Key That Fits the Lock

At any time, around 10% of people carry meningococcal bacteria in the nose and throat, which can cause meningitis, blood poisoning and other serious illnesses. Most people carry these bacteria and never become ill, yet a very small proportion go on to develop these illnesses which can result in life long disabilities or death. The mechanism by which this happens is poorly understood and has been studied in various ways, usually focussing on the bacteria or on the individual, but none has given a definitive answer. This study will be the first of its kind and will assess the interaction between the host and the bacteria at the genetic level, through genetic mapping, helping us to understand what makes some people susceptible to this infection.

At any time, around 10% of people carry meningococcal bacteria in the nose and throat, which can cause meningitis, blood poisoning and other serious illnesses. Most people carry these bacteria and never become ill, yet a very small proportion go on to develop these illnesses which can result in life long disabilities or death. The mechanism by which this happens is poorly understood and has been studied in various ways, usually focussing on the bacteria or on the individual, but none has given a definitive answer. This study will be the first of its kind and will assess the interaction between the host and the bacteria at the genetic level, through genetic mapping, helping us to understand what makes some people susceptible to this infection.

Eligibility Criteria:
Inclusion Criteria:

* any individual with culture-confirmed IMD in England from 01 September 2015 to 31 August 2019
* written informed consent from the individual, the parent (for children aged \<16 years) or next-of-kin (for non-survivors)

Exclusion Criteria:

* any individual who does not fulfil the inclusion criteria

Temporary Exclusion Criteria:

* Critically-ill patients and/or their family member will be only approached when the patient starts recovering from their illness or after they are deceased, on the advice of their clinical team.
Normal Saline Vrs Balanced i.v. Fluids in Neurosurgery

The purpose of this study was to investigate whether the balanced fluids therapy change plasma osmolality in neurosurgical procedures due to brain tumors, meningeomas and arterio-venous malformation.

Normal saline or 0.9% sodium chloride solution is the most commonly used intravenous fluid worldwide and its composition are 154 mmol Na+ and 154 mmol Cl- per litter with osmolality of 308 mOsmol/L. That composition is not "normal" because plasma contains potassium in range between 137-146 mmol/L, and chloride in range between 98-106 mmol/L, with plasma osmolality of 280-295 mOsmol/kg. Recently published data suggested detrimental effects of chloride rich fluids on renal blood flow and glomerular filtration rate, urine output and acute kidney injury. One alternative to saline solution is a buffered, balanced, crystalloid solution with an electrolyte composition similar to plasma and osmolality between 286-295 mOsmol/L. Someone could indicate that such balanced solutions are not suitable for neurosurgical patients because of a possible impact on the brain edema development.

Eligibility Criteria:
Inclusion Criteria:

* Patients with brain tumor, meningeomas and vascular malformation.

Exclusion Criteria:

* Patients with signs of elevated intracranial pressure; History of kidney disease, History of heart disease
Exploring the Tumor Micro-Environment with 68Ga-FAPi-46 PET/CT in Breast Cancer

This study is a prospective, non-interventional, open-label study to evaluate the glucose metabolism and the expression of the imaging agent 68 Gallium-Fibroblast Activation Protein Inhibitor-46 (68Ga-FAPi-46) with PET imaging, in woman affected by Breast Cancer (BC) and referred to diagnostic imaging work-up prior to primary therapy.

All patients affected by newly diagnosed, clinically N-positive BC that have already undergone a baseline 2-deoxy-2-\[fluorine-18\]fluoro-D-glucose (18F-FDG) PET/CT (T1) will be screened for eligibility. Patients who will meet all inclusion/exclusion criteria will be considered eligible and asked to participate to the study after signing the informed consent form. Patients' eligibility will be evaluated by the referent nuclear medicine physician (T2). Considering the clinical experience of the investigators, we expect to complete patient enrolment in 12 months after study accrual

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed, biopsy proven breast cancer;
* Diagnosis of invasive breast cancer;
* Tumor diameter more than 2 centimeters;
* Radiological evidence of axillary nodes involvement;
* 18F-FDG PET/CT performed as baseline diagnostic procedure, during routine diagnostic work-up;
* 68Ga-FAPi-46 PET/CT performed within 4 weeks from 18F-FDG PET/CT;
* Patients suitable to primary treatment (surgery or neo-adjuvant therapy);
* 68Ga-FAPi-46 PET/CT performed within 8 weeks from primary treatment;
* Female patients;
* Age ≥18;
* Willing to sign informed consent form.

Exclusion Criteria:

* Pregnant or nursing patients;
* Unable to stay flat and cannot tolerate PET scan;
* Sample tissue from biopsy unavailable for assessing Fibroblast Activation Protein (FAP) expression;
* Eastern Cooperative Oncology Group (ECOG) performance status ≥2.
Bundling Gentle Body Massage Along With Regular Position Change Under Phototherapy

This study aimed to investigate the effect of bundling gentle body massage along with regular position change on bilirubin level and clinical outcomes among full-term neonates with hyperbilirubinemia under phototherapy.

Hypothesis

Full-term neonates with hyperbilirubinemia who receive gentle body massage along with regular position change exhibit less bilirubin level and better clinical outcomes than those who don't.

A quasi-experimental study was carried out in the NICU of XX. Sixty full-term neonates were randomly assigned to two equal groups.

The control group received the conventional NICU care of infants undergoing phototherapy. Phototherapy was given by single Blue LEDs emitting light in a narrow spectrum (450-470 nm). Initially, phototherapy lamps were checked and adjusted at the height of 30 cm from the neonates who were kept naked in the incubator/crib except for the reproductive organs with shielded eyes. The neonates were positioned supine under the phototherapy. The treatment was given continuously, except while feeding and nursing for 30 minutes every 3 hours. The neonates' skin was cleaned with warm water without applying any sorts of ointments oils or creams. They were also observed for signs of dehydration.

The intervention group received all basic routine care in addition to regular position change from supine to laterals under the phototherapy every two hours. They also received gentle body massage

Eligibility Criteria:
Inclusion Criteria:

* Full-term
* receive enteral feeding (breast, bottle, or mixed feeding, gavage)
* Newly admitted

Exclusion Criteria:

* Required exchange transfusion
* Required mechanical ventilation
* Has acute phase of circulatory insufficiency
* Hemolytic disease
* Neurological disorders
* Congenital anomalies
* Neonatal sepsis Diarrhea
Mechanisms of Improved Wound Healing and Protein Synthesis of Insulin and Metformin

Massive pediatric burns are associated with a persistent and sustained hypermetabolic response characterized by elevated levels of circulating catecholamine's, cortisol, and glucagon's, which can cause extreme muscle wasting, immunodeficiency, and delay in wound healing. Insulin and metformin have demonstrated anabolic activity with minimal associated side effects. However, it is unknown whether the beneficial effects arise from tight euglycemic control or direct effect of insulin action. We hypothesize that during acute hospitalization, administration of metformin at a dose titrated to maintain blood glucose between 80-180 mg/dl will accelerate wound healing and recovery in children with severe thermal injury and will have beneficial long-term effects on muscle strength, immune function, and wound healing.

Metformin treated patients will be compared to control patients. Both groups will receive insulin therapy for blood glucose \>180mg/dl. Insulin will be titrated according to hospital sliding scale.

The use of insulin or metformin will benefit burned children by improving muscle protein build-up, speeding wound healing and reversing growth arrest, improving the immune response, and positively affecting long-term rehabilitation.

The results of this study may initiate a change in standard of care as it is found that simply the reduction of blood glucose by metformin, improves patient outcomes as metformin can be administered without the added complication of hypoglycemia.

Eligibility Criteria:
Inclusion Criteria:

* Patient age 10-19
* Primary diagnosis of ≥ 20 Total Burn Surface Area Burn (TBSAB )

Exclusion Criteria:

* Decision not to treat due to burn injury severity
* Known history of AIDS, ARC, HIV
* Pregnancy
* Previous diagnosis (pre -burn) of renal failure, liver disease or hepatic dysfunction- Serum Creatinine \>1.5mg/dL for males and \>1.4mg/dL for females, after fluid resuscitation (Clinical definition of kidney damage)
* Pre-existing type 1 diabetes mellitus
* Pre Existing type 2 diabetes mellitus and receiving treatment
* Allergies to Metformin
* Acute or chronic acidosis (lactic or any other metabolic type) and renal failure
Study Comparing Fish Oil and Krill Oil

Eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) are omega-3 fatty acids found in fish oil and in krill oil. The purpose of this study is to compare the effects of the recommended dose of a fish oil supplement (Omax3 4:1 EPA:DHA; recommended daily dose 1650 mg - totaling 1500 mg EPA+DHA) and a krill oil supplement (MegaRed; recommended daily dose 300 mg - totaling 74 mg EPA+DHA) on omega-3 index, plasma biomarkers of inflammation and inflammatory cell activation, and plasma lipid levels in subjects with metabolic syndrome.

Inflammation plays a pivotal role in the pathogenesis of several chronic diseases including cardiovascular disease and diabetes mellitus. There has been some evidence that fish oil, containing the omega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), reduces the risk or severity of these diseases, leading several government and health organizations to advocate an increased consumption of fish or fish oil. Fish oil contains EPA and DHA either as triglycerides or as ethyl esters. Recently, krill oil has gained popularity as an EPA and DHA supplement. Krill oil contains EPA and DHA in phospholipid, triglyceride, and free fatty acid form.

Some studies have shown that the bioavailability of EPA and DHA in krill oil is higher than in fish oil and that smaller doses of krill oil are therefore sufficient to observe a significant effect on the desired outcome (inflammation, plasma lipid levels).

The central hypothesis of this proposal is that the dose of the EPA and DHA omega-3 fatty acids is more important than their bioavailability in effecting changes in systemic inflammation and lipid metabolism.

Eligibility Criteria:
Inclusion Criteria:

* fasting plasma triglyceride levels between 150 and 500 mg/dL
* C-reactive protein (CRP) levels ≥2 µg/mL
* at least one of the following criteria for the definition of metabolic syndrome: abdominal obesity (waist circumference \>40 inches in men and \>35 inches in women), hypertension (blood pressure ≥130/≥85 mmHg or use of anti-hypertensive medications), and fasting glucose ≥110 mg/dL.

Exclusion Criteria:

* high-fish diets (\>2 fish meals/week)
* taking fish oil supplements or supplements containing EPA or DHA
* regular use of anti-inflammatory medications
* Above normal coagulation time or use of anticoagulant medications
* allergy to fish, fish oil, or shellfish
* uncontrolled thyroid dysfunction
* insulin-dependent type 2 diabetes mellitus
* kidney or liver disease
* smoking
* drinking more than 7 alcoholic drinks/week
* use of lipid-lowering medications or medications known to alter lipoprotein metabolism
A Bioequivalence Study of SPARC_147709 in Patients With Multiple Myeloma

Safety and bioequivalence of SPARC_147709


Eligibility Criteria:
Inclusion Criteria:

* Availability for the entire study period and willingness to adhere to protocol requirements.
* Diagnosis of multiple myeloma and eligible for receiving Doxorubicin liposome
* 18 years of age or older
* No evidence of underlying disease (except multiple myeloma)

Exclusion Criteria:

* History or presence of significant allergy or significant history of hypersensitivity or idiosyncratic reactions to doxorubicin hydrochloride
* History of cardiovascular, pulmonary, hepatic, renal, gastrointestinal, endocrine, immunologic,dermatologic, musculoskeletal, neurological or psychiatric disease.
* History of smoking (≥ 10 cigarettes/day) or consumption of tobacco products (≥ 4 chews/day).
* Positive result to HIV, HCV, RPR and HBsAg.