cyrilzakka/clinical-trials huggingface dataset:
Application of Remote Ischemic Preconditioning in Patients Undergoing Open Heart Surgeries

Strategies for myocardial protection during open heart surgeries are desired. Several experimental studies have shown beneficial effects of remote ischemic preconditioning (RIPC). The underlying mechanisms are not totally understood. This study intends to evaluate molecular mechanisms involved with RIPC on myocardium of patients underwent open heart surgeries.


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years
* Scheduled for coronary artery bypass grafting with or without valve replacement associated
* Use of blood cardioplegia
* EuroSCORE II greater than or equal to 1.0%

Exclusion Criteria:

* History of cardiogenic shock
* Complications in the admission
* Pregnant patients
* Severe peripheral arterial disease affecting the upper limbs
* Liver failure (bilirubin ˃ 20 mmol / L, INR 2.0 ˃)
* Significant pulmonary disease (˂ FEV1 40%)
* Renal failure with glomerular filtration rate ˂ ml/min/1,73 m²
* Concomitant treatment with glibenclamide or nicorandil (medications that interfere with cardioprotection induced by IPCR)
Creation of a Small Cavity Reduces the Rate of Cement Leakage During Vertebral Body Augmentation

Leakage of polymethylmethacrylate (PMMA) is the most common complication during vertebral body augmentation and can lead to serious patient morbidity. Any measure to reduce the rate of cement leakage is of value and makes the procedure safer.The aim of this study was to investigate the effect of the creation of a cavity on cement leakage during vertebroplasty. Investigators tested the hypothesis that the creation of a merely small and irregular cavity in vertebral body prior to cement injection would reduce cement leakage.


Eligibility Criteria:
Inclusion Criteria:

* Osteoporotic vertebral body fractures of the thoracolumbar spine (T9 to L4) that were classified as A1 fractures according to Arbeitsgemeinschaft Osteosynthesis (AO) Classification

Exclusion Criteria:

* More Than 2 Vertebral Body Fractures
* Fractures of Vertebral Body Based on Malignancy
* Previous Spinal Operation
* Spinal Infection
* Spinal Deformity (scoliosis)
Complications of Exchange Transfusion in Neonates

Exchange transfusion is effective and considered to be safe procedure ; however, it is not without risks. Complications have been reported and mortality rates vary from 0.5 to 3.3%. therefore ,the current recommendation for performing exchange transfusion are based on balance between the risks of encephalopathy and complications related to the procedure .

About 60% of term and 80% of preterm infants have clinical jaundice in the first week after birth but only 2% to 16% of them develop severe hyperbilirubinemia (total serum bilirubin \> 25mg/dl) ,which is an emergency because it may cause neonatal bilirubin encephalopathy (kernicterus), which can result in death or irreversible brain damage in survivor.

Exchange transfusion is the standard method of therapy for immediate treatment of severe hyperbilirubinemia and prevention of kernicterus. Although the frequency of neonatal exchange transfusion has declined markedly in the past two decades, this procedure is still performed in many countries, especially in those with a high incidence of neonatal hyperbilirubinemia.

Exchange transfusion is effective and considered to be safe procedure ; however, it is not without risks. Complications have been reported and mortality rates vary from 0.5 to 3.3%. therefore,the current recommendation for performing exchange transfusion are based on balance between the risks of encephalopathy and complications related to the procedure .

Most of these complications are transient, such as severe thrombocytopenia, apnea, hypocalcemia , bradycardia, and hyperkalemia and recovery is expected along with appropriate care and follow up. But serious complications and even death can occurs due to cardiovascular collapse during exchange , necrotizing enterocolitis, bacterial sepsis, and pulmonary hemorrhage that can be avoided by careful cardio-pulmonary and oxygen saturation monitoring.

Eligibility Criteria:
Inclusion Criteria:

* All preterm and full term neonates who need exchange transfusion

Exclusion Criteria:

* Neonatal sepsis
* Congenital anomalies
Neo-nervegenesis in Inguinal Hernia Implant ProFlor

The investigation is aimed at specifically demonstrating the ingrowth of newly formed nervous elements within a 3D dynamic responsive implant for inguinal hernia repair.

Biopsy specimen were excised at defined postoperative stages from patients who underwent hernia repair with the 3D prosthesis named ProFlor. Scope of the study was to determine the presence, quantity and quality of the neural ingrowth within the implant fabric. Histology revealed the presence of multiple nerve clusters that, starting from the early stage post-implantation, increased in number and degree of maturation. In the long term, neural elements assumed the typical aspect of normal nervous structures complete in all components. The development of highly specialized tissue such as nerves, together with other components of the abdominal wall already described in literature, seems to finalize a regenerative response. This kind of behavior, being the expected result from a device intended for the cure of inguinal hernia and its degenerative source, seems to be coherent with the pathogenesis of the disease.

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent inguinal hernia repair with the prosthetic device named ProFlor
* Patients undergoing recurrent inguinal hernia repair after primary repair with the prosthetic device named ProFlor
* Patients undergoing surgical procedure in the groin area after inguinal hernia repair with the prosthetic device named ProFlor

Exclusion Criteria:

* Patients who underwent inguinal hernia repair with conventional flat meshes
Incidence of Retained Surgical Devices and Treatment

It has been estimated that in the United States alone 48 million operations are performed annually and most involve the use of multiple surgical items, including needles and other sharp objects, surgical sponges, and surgical instruments1. Textile material and instruments forgotten in a patient undergoing an invasive procedure is a negligence of an entire team responsible for maintaining patient safety. A retained surgical foreign body (RSFB) usually requires at least a second surgery for retrieval of the object, and also carries a risk for major complications including morbidity and death2. Retained foreign bodies are underreported to minimize exposure to possible litigation3. Therefore, the real occurrence of RSFB is underestimated, recently there has reported an incidence of 0.356 / 1,000 patients whereas others reported a rate of 1/5000 with an associated mortality ranging from 11 to 35% 4-5.

Therefore, there is a need for improved systems and methods for identifying and tracking surgical items, including needles and other sharp objects, surgical sponges, and surgical instruments during a surgical procedure.

All cases investigated due to retained material during hospital surgical treatment will be included. Incidence, type of procedure performed, the prevalence and guilty of the personal actuating will be considered.

Eligibility Criteria:
Inclusion Criteria:

* Any patient who during internment for surgery had an accident of forgetfulness in the material used for their treatment.

Exclusion Criteria:

* No exclusion criteria
Comparing the Efficacy of Intranasal Midazolam Versus Intravenous Diazepam for Control of Seizures in Children

After approval , study will be conducted at the Children Hospital PIMS, Islamabad. Children 1-12 years presenting/admitted with seizures will be enrolled in the study after taking informed consent from the parents. Children's name, age, sex will be recorded by the on duty doctor. Patients will be randomly allocated to two equal groups. Group A (GA) will receive single dose of intravenous diazepam (0.2mg/kg/dose)after passing cannula, while Group B (GB) will receive single dose of intranasal midazolam (0.2mg/kg/dose).Response to treatment will be assessed by recording the time required for termination of seizures in both gruops.the time required for gaining intravenous accessin Group A will be recorded as well. Data will be collected through a structured performa.

Benzodiazepines are the first line of drugs for cessation of acute seizures.benzodizepines can be given intravenous,orally,per rectal and intranasal.Conventional treatment of acute seizures is intravenous diazepam in most hospital settings which requires an IV access,which is not possible for parents to give at home.The main problem in an actively seizuring child is to reach the hospital and maintaining an intravenous line.Midazolam is a water soluble benzodiazepine which is widely used as an anxiolytic and anticonvulsant ,can be given through intravenously,intramuscularly, oral,buccal and nasal mucosa as well.it becomes lipid soluble at physiologic PH levels and reaches the CNS with a rapid onset and shorter duration of action.It is administered into nostril in a way that it comes into direct contact with nasal mucosa.It is given in a dose of 0.2mg\\kg and within a few minutes its level in serum are comparable to the injectables levels.It is a safe,cheap,easy to use and effective alternative to diazepam for use at home as well as in hospital settings.

Eligibility Criteria:
Inclusion Criteria:

* Children 1-10 years both male and female visiting/admitted in Children Hospital PIMS with acute episode of seizure (febrile or afebrile)

Exclusion Criteria:

* Children requiring emergency resuscitation
* Children with uncontrolled epilepsy
Effect of Metabolic Surgery on Live Birth Rate of Offspring in Obesity Polycystic Ovarian Syndrome Patients

This is a experimental study, which subjects are obese PCOS patients requiring LSG surgery. Aim to investigate the effects of LSG surgery in PCOS patients whether increases the live birth rate of the offspring.

The investigators designed a single center small sample exploratory study to clear the therapeutic effects of laparoscopic sleeve gastrectomy on live birth rate improvements of overweight/obese PCOS patients. The investigators plan to enroll 18 patients. Inclusion criteria: 1) Patients who are aged from 18 to 45, not menopause;2) have PCOS which is diagnosed according to 2003 Rotterdam criteria; 3) have been treated with behavioral and drugs intervention for 3 months but are ineffective; 4) have steady or steady weight gain over 5 years, BMI\>35kg/m2, or BMI\>30kg/m2 with one of the metabolic disorders such as impaired glucose tolerance, cardiovascular disease, fatty liver, lipid metabolism disorders, sleep apnea syndrome.

Patients with serious complications (cardiovascular events and recent significant liver, kidney or lung disease within 3 months); high blood pressure (\>160/100mmHg); active infection; secondary diabetes; pregnancy; alcohol abuse; surgical contraindications are excluded.

Then the investigators plan to perform laparoscopic sleeve gastrectomy . Before and after the intervention, the blood samples would be collected to detect blood glucose, insulin, lipid profile, sex hormones, blood chemistry for liver and kidney function, hsCRP etc., as well as the anthropometric measurement and image examinations. All patients are followed up every 3 months until the end of the program. All patients receive MRI plain scan of upper and lower abdomen, oral glucose tolerance test (OGTT) and insulin, C-peptide releasing test again every 6 months after the operation. One year after the operation, patients would be evaluated whether they are suitable for pregnancy preparation and record the pregnancy mode. After pregnancy, various indicators would be closely monitored, including maternal vitamin and trace element levels.The birth of children and the live birth rate would be recorded.

The investigators will compare the data and finally identify the treatment effect of laparoscopic sleeve gastrectomy on overweight/obese PCOS patients.

Eligibility Criteria:
Inclusion Criteria:

- aged from 18 to 45, not menopause have PCOS which is diagnosed according to 2003 Rotterdam criteria have been treated with behavioral and drugs intervention for 3 months but are ineffective have steady or steady weight gain over 5 years, BMI\>35kg/m2, or BMI\>30kg/m2 with one of the metabolic disorders such as impaired glucose tolerance, cardiovascular disease, fatty liver, lipid metabolism disorders, sleep apnea syndrome

Exclusion Criteria:

- Except for serious complications (cardiovascular events and recent significant liver, kidney or lung disease within 3 months) high blood pressure (\>160/100mmHg) active infection secondary diabetes pregnancy alcohol abuse surgical contraindications
Pressure Controlled Versus Volume Controlled Mechanical Ventilation During Anesthesia for Living Donor Liver Transplantation Recipients

pressure controlled ventilation will improve oxygenation indices , hemodynamics during anesthesia for living donor liver transplantation recipients ,improving postoperative graft function and decreasing postoperative pulmonary complications


Eligibility Criteria:
Inclusion Criteria:

* all living donor liver transplantation recipients scheduled

Exclusion Criteria:

* Moderate to severe restrictive pulmonary functions
Foley's Catheter Balloon Plus Tranexamic Acid During Cesarean Delivery for Placenta Previa

Placenta previa (PP) is an obstetric condition that is closely linked with massive obstetric hemorrhage with a varied incidence about once in every 150-250 live births. Insertion of intrauterine balloon tamponade has been suggested in the management of massive postpartum hemorrhage (PPH). The Bakri balloon has a sausage-like spindle shape and a drainage lumen and is made of silicon. It has been used in cases of uterine atony and placenta previa with a success rate of 90%. However, Bakri balloon is not available in all countries.

The aim of this study is to evaluate the efficacy of the use of intrauterine inflated Foley's catheter balloon with or without intravenous tranexamic acid to control PPH during cesarean delivery in cases of placenta previa.

Eligible participants were allocated to one of two groups. Group (I): patients managed by Intrauterine Inflated Foley's Catheter Balloon after delivery of the fetus. Group (II): patients received 1 gm tranexamic acid (TA), (2 ampoules of Capron® 500 mg /5 ml; Cairo, Egypt) intravenous just before skin incision plus Intrauterine Inflated Foley's Catheter Balloon. In group I, patients received a single injection of intravenous saline before skin incision prepared in a syringe and coded by a pharmacist in the pharmacy of the hospital. Neither the surgeon nor the anesthetist will know the nature of the IV administered drug before cesarean section.

Eligibility Criteria:
Inclusion Criteria:

* all pregnant women with a single term fetus scheduled for an elective cesarean section for complete placenta previa

Exclusion Criteria:

* Patients with a cardiac, hepatic, renal or thromboembolic disease
* patients with the high possibility of the morbid adherent placenta
* known coagulopathy or thromboembolic disease
* those presented with severe antepartum hemorrhage
* hypersensitivity or contraindications of use of tranexamic acid
* patient refuses to consent
Mindfulness-Based Relapse Prevention for Opioid and Alcohol Use Disorders

A randomized controlled trial will examine mindfulness-based relapse prevention (MBRP) program outcomes for 240 individuals who have completed treatment for opioid or alcohol use disorders. MBRP is a group aftercare program that integrates mindfulness skills training with cognitive-behavioral relapse prevention strategies. Primary outcomes will include frequency of opioid/alcohol use, craving, withdrawal, and quality of life. Secondary outcomes include time to first opioid/alcohol use, adherence to medication-assisted treatment plans, perceived stress, posttraumatic stress symptoms, and chronic pain. We will also examine the following potential moderators of intervention outcomes: comorbid diagnoses, life events history, and MBRP intervention adherence. In addition, we will examine the following mediators of intervention outcome: mindfulness skills, emotion regulation skills, executive functioning skills, savoring, and positive and negative affect.

A randomized controlled trial will examine mindfulness-based relapse prevention (MBRP) program outcomes for 240 individuals who have completed treatment for opioid or alcohol use disorders. Participants will be recruited from outpatient medical clinics and substance use recovery centers. They will be assigned to an intervention group (Group 1) or waitlist control (Group 2), completing assessments at baseline, 8, and 16 weeks. Group 1 will receive the intervention in weeks 1-8 and group 2 will receive the intervention in weeks 9-16. MBRP is a group aftercare program that integrates mindfulness skills training with cognitive-behavioral relapse prevention strategies. Primary outcomes will include frequency of opioid/alcohol use, craving, withdrawal, and quality of life. Secondary outcomes include time to first opioid/alcohol use, adherence to medication-assisted treatment plans, perceived stress, posttraumatic stress symptoms, and chronic pain. We will also examine the following potential moderators of intervention outcomes: comorbid diagnoses, life events history, and MBRP intervention adherence. In addition, we will examine the following mediators of intervention outcome: mindfulness skills, emotion regulation skills, executive functioning skills, savoring, and positive and negative affect.

Eligibility Criteria:
Inclusion Criteria:

* over 18 years of age
* completed behavioral health treatment for Opioid Use Disorder (OUD) or Alcohol Use Disorder (AUD) within the previous eight weeks
* continues to be followed by a behavioral health provider
* meets DSM-5 criteria for OUD or AUD
* English fluency
* able to attend intervention sessions

Exclusion Criteria

* current psychosis
* dementia
* moderate to severe traumatic brain injury
* pregnancy
* active suicidality
* persistent antisocial behavior
* acute episode of an SUD (past two weeks)
* persistent self-injury requiring clinical management
* already completed or attending a mindfulness-based intervention
Pharmacokinetics of Tedizolid Phosphate in Cystic Fibrosis

The proposed study is designed to characterize the pharmacokinetics of intravenous and oral tedizolid in patients with Cystic Fibrosis.

Recent epidemiological studies have demonstrated that the presence of methicillin-resistant Staphylococcus aureus (MRSA) in the airways of patients with CF is associated with more rapid lung function decline and a higher mortality. Tedizolid is a new antibiotic with potent activity against MRSA. Tedizolid is currently FDA approved for treatment of skin soft tissue infections with MRSA. The proposed study is designed to characterize the pharmacokinetics of intravenous and oral tedizolid in patients with CF.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of CF based on positive sweat chloride or known CF mutation
* Age \> 17 years
* Able to spontaneously expectorate sputum

Exclusion Criteria:

* Any clinically significant laboratory abnormalities
* Presence of an ongoing acute pulmonary exacerbation
* Pregnancy
* Serious past allergy to linezolid or tedizolid
* No alcohol, nicotine, or caffeine-containing products during the study period
Relative Bioavailability Study on a Single Dose of GW842166X in Healthy Male and Female Subjects.

GW842166X is a selective non-cannabinoid CB2 receptor agonist, which is undergoing clinical development as a novel oral treatment for inflammatory pain. The purpose of the study is to compare the effects of formulation, food and particle size on the pharmacokinetic profiles of a single 175mg dose of GW842166X in healthy male and female volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Body weight \>50 Kg and BMI within the range 18.5-29.9 Kg/m2 inclusive.
* Healthy as judged by a responsible physician.

Exclusion Criteria:

* Positive pre-study urine screen for drugs of abuse or alcohol breath test.
Study Of Atopic Dermatitis In Pediatrics

To verify of cetirizine dry syrup to ketotifen dry syrup in the change in the severity of pruritus of the treatment period.


Eligibility Criteria:
Inclusion Criteria:

* Children diagnosed as atopic dermatitis
* Giving informed consent
* Children who have 2 grades or more pruritus score.
* Children who require the treatment with external steroid preparation other than face and head.
* Children with a pruritus severity of 2.
* Mild or severe on the fist day of the treatment period.

Exclusion criteria:

* have spastic disease such as epilepsy
* have a history of drug hypersensitivity
* are lactating or possibly pregnant female Children
* have a skin infection, or with zooparasite such as scabies and pediculosis
* cannot avoid the use of external steroid classified into strong, strongest or very strong
* have eczematous otitis externa with perforation in the eardrum
* have dermal ulcer, or profound heat burn or frostbite of the severity higher than the grade 2
* have asthma that requires the treatment with corticosteroid
* have pruritus only on face and head
* have inappropriate complication of dermal disorder that may influence on the evaluation of the study drug
* are undergoing specific desensitization therapy or immunomodulation therapy or phototherapy.
Impacts of Training on Effortful Listening

Human listeners will hear speech masked by single-talker speech before and after auditory training.

Human listeners will hear speech masked by single-talker speech before and after auditory training. Training-related changes in EEG dynamics and behavioral measures of accuracy and effort will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* normal hearing

Exclusion Criteria:

* hearing loss