cyrilzakka/clinical-trials huggingface dataset:
The Effect of Intracapsular Injection of Terlipressin Versus Carbitocin on Hemoglobin and Blood Loss During Laparoscopic Myomectomy Operations

Our study aims to evaluate the efficacy of intracapsular injection of Terlipressin versus Carbetocin injection on hemoglobin level in women undergoing abdominal laparoscopic myomectomy. Moreover, to evaluate their efficacy in decreasing blood loss on operative time and to describe the injection sequelae for the same population. This clinical study will be conducted in compliance with the clinical study protocol and applicable regulatory requirements.

This study is a prospective, comparative, double-blinded randomized placebo-controlled trial and multi-center study that will be conducted at Wael ElBanna Clinic and the NRC site. The study participants' relevant medical records will be collected and reviewed after obtaining informed consent for the participants. Data will be pooled and presented in aggregate, without the identification of individual subjects. The study materials that will be used will include blood tests and ultrasound. The study will involve three study arms:

* Arm 1: intramyometrial injection of Terlipressin in women undergoing laparoscopic myomectomy procedure
* Arm 2: intramyometrial injection of Carbetocin in women undergoing laparoscopic myomectomy procedure
* Arm 3: intramyometrial injection of saline in women undergoing laparoscopic myomectomy procedure Subjects who meet diagnostic requirements as listed in the inclusion and exclusion criteria will be included in the study. Women will be randomized to one of the three arms using a computer-generated randomization table with a 1:1:1 group allocation.

Eligibility Criteria:
Inclusion Criteria

1. Women aged 16-45 years
2. Appropriate medical status for laparoscopic surgery (largest myoma ≤15 cm)
3. Baseline hemoglobin ≥9 g/dl
4. No contra-indications to the use of glyopressin or carbitocin
5. Myoma-related symptoms, such as pelvic pressure or pain, menorrhagia, or infertility
6. Not pregnant at the time of presentation (i.e., negative urine pregnancy test or last menstrual period within the last 4 weeks)

Exclusion Criteria:

1. Previous myomectomy
2. History of bleeding disorders
3. Concurrent anticoagulation therapy
4. History of Uncontrolled ischaemic heart disease
5. Any pelvic abnormalities requiring concomitant surgery
6. Treatment with a GnRH agonist or ulipristal acetate within three months preceding surgery
7. Inability to understand and provide written informed consent
Two Contrasting Interventions for Sleep Management

This study will determine whether Mind-Body Bridging (MBB), a mindfulness training program is more effective than a common sleep medication, Zolpidem, in treating insomnia. It will also investigate whether MBB is additionally beneficial for co-morbid conditions such as stress, PTSD, depression, etc, compared with that of Zolpidem.

Sleep disturbance in active duty military personnel is highly prevalent and contributes to reduced performance of military duties. Under extreme conditions, army personnel could endanger themselves and their comrades. Increasingly, non-pharmacological treatments for insomnia are showing promise as complementary and alternative medicine treatments. Many of these awareness training programs (ATPs) perform as well as, or even better than, medications. This study will determine whether Mind-Body Bridging (MBB), an ATP that teaches awareness/mindfulness and cognitive skills, is more effective than a common sleep medication, Zolpidem. The study will also determine whether MBB exhibits additional benefits in co-morbid mental health conditions, including, stress, PTSD, depression, etc, compared with that of Zolpidem. This will offer soldiers additional treatment options for insomnia in the hope that it will improve both sleep and other common comorbidities.

Eligibility Criteria:
Inclusion Criteria:

* primary insomnia
* secondary insomnia
* requiring sleep medication (Zolpidem) for a three-week trial.
* active duty military service member stationed at Fort Carson.

Exclusion Criteria:

* secondary insomnia to a likely medical condition, such as sleep apnea, chronic obstructive pulmonary disease, restless leg syndrome, and other sleep disorders, which are not appropriately treatable with sleep medication.
* treated for sleep problems using sleep medications which include Lunesta, Ambien, Ambien Controlled Release (CR), Seroquel, Trazodone or Remeron
* major psychopathology (i.e., schizophrenia)
* severe depression within the past 90 days
* suicidal ideation within the past 90 days
* psychiatrically hospitalized within the past 90 days
* uncontrolled hypertension or diabetes
* pregnancy
* previous use of Zolpidem proved to be ineffective or to cause other unwanted side effects
* actively abusing controlled substances
* enrolled in another study
Factors Impacting the Prevalence of MDR Bacteria

1. To determine the prevalence of multidrug resistance bacteria in patient with different infections
2. To evaluate patients' predictive risk factors of antimicrobial resistance
3. To assess the association between patients' factors and prevalence of MDR bacteria

Antimicrobial resistance is one of the most critical public health issue in this century . WHO declared antimicrobial resistance as one of the top ten global health threats that impend the effective management and prevention of evolving infections .

Antimicrobial resistance nowadays poses a big challenge because of the emerging of resistance to the antibiotics that previously effective and development of multidrug resistance infections with subsequent increase in morbidity, mortality and financial loss .

In spite of WHO health strategies that taken to face multidrug resistance problem, the burden of antimicrobial resistance in Europe is compared with combined burden of influenza and HIVS .while in USA the estimated antibiotics resistance infections is 2.8 millions and the related deaths exceeded 35,000 every year and expected to reach to ten million deaths with collective cost of 100 trillion USD annually in 2050 .

Numerous studies reported that self-medications, improper prescription, overuse of antibiotics, deficiency of antibiotics susceptibility test and limited knowledge and attitude of population towards antibiotics are the main factors that lead to antibiotics efficacy being reduced with long hospital stay. Other studies stated that the predictive indicators of MDR tragedy are age, gender, comorbidities, previous hospital stay or antibiotic use .

In low and middle income countries like IRAQ there is a difficulty in estimation the scope of antibiotics resistance problem and its evolving over time due to the lack of surveillance, besides alarmingly excessive antibiotics consumption added other challenges and urged us to aim this study .

Eligibility Criteria:
Inclusion Criteria:

* patients who were screened for MDR bacteria
* patients who accepted to participate in the study

Exclusion Criteria:

* patients with no growth media
* patients who cannot communicated
GrafixPL PRIME Evaluation Case Study

The investigators plan to evaluate healing in a cohort of patients with chronic wounds (n=40) that receive optimal treatment including serial wound debridement and off-loading with total contact casts or a boot and GrafixPL PRIME. In addition, the investigators will collect data on other potential confounding factors that could affect healing such as medications, tobacco, nutrition, comorbidities, diabetes control, infection, perfusion, and activity. Wound healing, including wound size and adverse events will be evaluated. The objective of this study is to understand the use of this product to evaluate wound healing in 40 patients.

Screening and Enrollment:

* Review and sign the Informed Consent and HIPAA Authorization
* Review the inclusion and exclusion criteria

If the subject qualifies for the study, they will participate in the following procedures (weekly visits, +/-4 days):

Visit 0:

* Demographics (such as age, gender, race or ethnicity)
* Medical/Surgical and Social History, Current Antibiotics.
* Laboratory Results
* Vascular - ABI
* Neurological evaluation - Monofilament and VPT
* Vitals - Sitting blood pressure and Pulse rate, Height/Weight, and BMI
* Wound debridement
* eKare - Wound imaging measurement
* Application of GrafixPL PRIME
* Current Antibiotics
* Offloading
* Adverse Events
* Source documentation

Visits 1 - 11:

* Wound debridement
* eKare - Wound imaging measurement
* Application of GrafixPL PRIME
* Current Antibiotics
* Offloading
* Adverse Events
* Source documentation

Visit 12/End of Study (EOS) Visit:

* Wound debridement
* eKare - Wound imaging measurement
* Current Antibiotics
* Offloading
* Adverse Events
* Source documentation (End of Study will occur on the date the subject is healed)

Eligibility Criteria:
Inclusion Criteria:

* Able to provide informed consent
* 18-90 years of age
* Chronic foot ulceration below the ankle - persistent for 30 days or longer
* Ankle Brachial Index (ABI) \>0.5 (Bedside ABI is acceptable for screening purposes as the formal imaging ABI may not be resulted prior to surgery)

Exclusion Criteria:

* Unable to provide informed consent
* \<18 or \>90 years of age
* History of poor compliance with follow-up visits
* Gangrene
* Untreated Osteomyelitis
* Widespread malignancy
* Active alcohol or substance abuse such as cocaine, heroin, or methamphetamines
* Currently Pregnant or planning pregnancy during the course of intended participation in the study
* Is nursing or actively lactating
Topical Formulations of Liposomal Local Anesthetics

This blinded cross-over study aim to evaluate the efficacy of topical liposome-encapsulated ropivacaine formulations.

This blinded cross-over study aim to evaluate the efficacy of topical liposome-encapsulated 1 and 2% ropivacaine gel formulations.

Eligibility Criteria:
Inclusion Criteria:

* Healthy

Exclusion Criteria:

* Volunteers were free from cardiac, hepatic, renal, pulmonary, neurological, gastrointestinal and haematological diseases, psychiatric disorders and allergy to local anesthetics
Evaluation of Neutrophil/Lymphocyte Ratio ,Platelet/Lymphocyte Ratio and CRP as Markers of Severity of Pre-eclampsia

Evaluation of neutrophil/lymphocyte ratio, Platelet /lymphocyte ratio and CRP as markers of severity of Pre-eclampsia


Eligibility Criteria:
Inclusion Criteria:

- PREECLAMPSIA from 25_45years

Exclusion Criteria:

* chronic diseases Primary hypertension
Clinical Trial of YH14755 in Subjects With Dyslipidemia and Type II Diabetes

Randomized, double-blind, active-controlled, multicenter phase 3 trial to evaluate the safety and efficacy of YH14755 in subjects with dyslipidemia and Type II Diabetes.

This is a phase 3 trial to evaluate the safety and efficacy of YH14755 in subjects with dyslipidemia and Type II Diabetes.

In YH14755 treatment group, 88 subjects will be assigned and the subjects administer YH14755 for 16 weeks.

In Metformin treatment group, 88 subjects will be assigned and the subjects administer Metformin for 16 weeks.

In Rosuvastatin treatment group, 88 subjects will be assigned and the subjects administer Rosuvastatin for 16 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent
* Subjects with Dyslipidemia and Type II Diabetes
* 6.5% ≤ HbA1c level ≤ 9.0% and LDL-C level ≤ 250mg/dL(6.5 nmal/L) at screening
* BMI ≤ 45kg/m2
* Subjects who dose not administered diabetes treatment at least 4 weeks prior to screening visit.
* 19 years later, men and women under the age of 75

Exclusion Criteria:

* Pregnant women, nursing mothers or subject who does not agree to assigned contraception in the study
* Subject with type I Diabetes
* Subject with hypertension which does not controlled by treatment(have blood pressure \> 160/110mmHg)
* Have a known allergy to drugs
* Have administered Cyclosporine
* Have administered Obesity treatment within 12 weeks prior to screening visit
* Participated in any other clinical trials within 30 days prior to the first administration
* Subject who is judged to be ineligible by investigator
Perindopril Amlodipine for the Treatment of Hypertension

The purpose of the study is to evaluate the safety and efficacy of a fixed-dose combination drug compared to two other drugs (monotherapies) in controlling hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Essential hypertension
* For female subjects, a negative serum pregnancy test
* Ability to provide written informed consent

Exclusion Criteria:

* Night shift workers whose work hours include midnight to 4:00 a.m.
* Secondary hypertension
* An arm size that precludes the use of the digital blood pressure monitor cuff (arm size \> 42 cm)
* Renal dysfunction, severe renal impairment, bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, subjects with only 1 kidney, or post-renal transplant subjects
* Female subjects who are pregnant, planning to become pregnant
* History of malignancy within 5 years
* Primary aldosteronism
* Heart failure (NYHA functional class 3-4), hypertrophic obstructive cardiomyopathy, or hemodynamically relevant stenosis of the aortic or mitral valve
* Significant cardiac arrhythmias, MI, stroke, CABG, PTCA, unstable angina
* Known hypersensitivity to any component of the study drugs

Other protocol-defined inclusion/exclusion criteria may apply
AUGMENTIN 1gm In Skin And Soft Tissue Infection

Study to evaluate the effects of AUGMENTIN 1gm in the treatment of Skin and Soft tissue infections


Eligibility Criteria:
Inclusion Criteria:

* having diagnosed uncomplicated soft tissue infection (e.g furuncle, cellulitis)
* has given freely documented consent.

Exclusion Criteria:

* antibiotics
* have renal or hepatic insufficiency
* systemic toxicity
* pregnancy
* lactation
* hypersensitivity to penicillin or Beta-lactam antibiotics
Treatment Options for Pediatric Chronic Pain: How do we Best Disseminate Our Scientific Findings

Pediatric chronic pain is a prevalent condition with manifold treatment options. However, knowledge of targeted dissemination of intervention research findings is currently lacking.

The aim of this project is to determine satisfaction with current knowledge transfer from science to clinical practice amongst health care professionals, adolescents with CPP and their parents and to understand what treatment options have been offered to patients in Swiss pain centers Three focus groups, one with health care professionals, one with adolescent patients, and one with their parents, will be conducted to determine how the dissemination of scientific evidence to clinical practice can be improved and what hurdles exists when gathering information about pain interventions. In addition, patients will be asked about the treatment options offered to them and health care professionals about which treatments they routinely prescribe and why.


Eligibility Criteria:
Inclusion Criteria:

Adolescent group:

* Adolescents suffering from chronic pain (i.e., persistent or recurrent pain for three months or more)
* Able to read and speak German

Parent group:

* Parents of an adolescent with chronic pain
* Able to read and speak German

Health care professionals group:

* Health care professional working with adolescents with chronic pain
* Able to read and speak German

Exclusion Criteria:

* no chronic pain or experience with chronic pain
Further Lipid-Lowering With PCSK9 Inhibitors for Cardiovascular Outcomes in High-Risk Coronary Plaques Assessed by CT Angiography

The primary objective was to evaluate the effect of PCSK9 inhibitors in addition to the background lipid-modifying therapy (LMT), compared with placebo plus background LMT in terms of clinical outcomes in patients with coronary CT angiography (CCTA)-detected high-risk plaques.

CCTA is an accurate, noninvasive alternative to invasive coronary angiography. CCTA can provide detailed information about the characteristics of coronary artery plaques, such as their composition, morphology, and distribution. Various CCTA-detected plaque characteristics indicative of plaque quantity and quality have been identified as high-risk features independently predicting clinical events, including the presence of positive remodeling, low attenuation plaque, spotty calcification, and napkin ring sign. Currently, the treatment for CCTA-detected high-risk plaque has been receiving increasing interest. The current study aimed to prove the efficacy of PCSK9 inhibitors in addition to the background LMT, as compared with placebo plus background LMT in patients with CCTA-detected high-risk plaques.

Hypothesis: PCSK9 inhibitors in addition to background LMT will show a superior event rate, compared with placebo plus background LMT, in terms of major adverse cardiac and cerebrovascular events (MACCEs) at 24 months after the last patient's randomization in patients with high-risk coronary plaques assessed by CT Angiography.

Eligibility Criteria:
Inclusion Criteria:

1. Subject must be ≥ 18 years.
2. Patients with at least one target lesion meet CCTA-detected plaque features of the following:

   1. Degree of stenosis ≥ 50%
   2. At least 2 of the following high-risk plaque features:

   i. Low-attenuation plaque ii. Positive remodeling iii. Napkin-ring sign iv. Spotty calcium
3. The target lesion is located at the proximal or mid segment of left anterior descending artery, left circumflex artery or right coronary artery.
4. Subject is able to confirm his/her understanding of the risks, benefits, and treatment alternatives of receiving study-related treatment. He/she or his/her legally authorized representative provides written informed consent prior to any study-related procedure.

Exclusion Criteria:

1. Target lesions underwent or planned to revascularization.
2. Patients with acute coronary syndrome.
3. New York Heart Association class III or IV, or last known left ventricular ejection fraction \< 30%.
4. Uncontrolled or recurrent ventricular tachycardia.
5. Homozygous familial hypercholesterolemia.
6. Active liver disease or hepatic dysfunction.
7. Failed CCTA plaque analysis.
8. Non-cardiac co-morbid conditions with life expectancy \< 2 years.
9. Pregnant and/or lactating women.
10. Known hypersensitivity or contraindication to statin or PCSK9 inhibitors.
Reduction of Post Intravitreal Injection Bleeding and Pain by Ice

Intravitreal injections are an efficient method for delivering intraocular therapeutic agents in numerous ophthalmologic diseases. However, side effects, such as pain and subconjunctival hemorrhage remain a major concern.

Prevention or alleviation of those side effects might shorten the healing duration and improve patients' quality of life.

cooling the eye using ice patched prior to Intravitreal injections may ameliorated pain and subconjunctival hemorrhage incidences.

Eligibility Criteria:
Inclusion Criteria:

patients receiving intravitreal injection

Exclusion Criteria:
Bone-Implant Contact Surface Influence on Dental Implant Stability

This study aims to evaluate the changes in the stability and bone-implant contact surface of implants of the same macro-design placed with particle grafting in the fresh extraction socket, without grafting, and placed in healed implant sites.


Eligibility Criteria:
Inclusion Criteria:

* Having a non-repairable premolar or molar tooth, or an edentulous area where the corresponding teeth have been extracted at least six months ago,
* At least 18 years old,
* Maintaining good dental hygiene,
* Having a favorable occlusion,
* Having intact socket walls after extraction.

Exclusion Criteria:

* Any local or systemic disorders that had contraindications for dental implant insertion,
* Pregnant and lactating women.
Evaluation of Subcutaneous Immunotherapy Towards Pollen in Children

The objective is to prospectively explore associations between immunological parameters in blood and clinical effect of subcutaneous immunotherapy (SCIT) in children with severe allergy towards pollen. Half of the children will receive SCIT while the other half will start SCIT after the study is finished. Clinical evaluations of symptoms and an immunological survey will be performed before start of SCIT and after one year of treatment. Some of the immunological parameters will also be checked after 6 months of treatment

Before start of SCIT, with Alutard pollenextract/s from " Allergologisk Laboratorium Köbenhavn" (ALK), and after one year of treatment, immunoglobulin E (IgE)-antibody levels towards the crude allergen and important allergen components in birch and grasspollen (timothy) will be measured in blood. While IgE- antibodies are considered to be an indicator of allergy IgG- and IgG4-antibodies are considered to be "blocking" antibodies in IgE-mediated allergy. Therefore the investigators will measure the IgG- and IgG4-antibody levels to crude allergens and applicable allergen components before start, when maintenance dose is reached (after 6 months) and after one year of treatment. In order to evaluate quality of life, a validated form (DISABKIDS) will be used. Symptom score will be rated by a validated form (LILA). The need for medication to treat allergic rhinitis and asthma will be assessed using questionnaires. A conjunctival provocation with the applicable allergen(s) will be performed before start of SCIT and after one year of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Seasonal Rhinoconjunctivitis caused by grass and/or birch pollen allergy
* Insufficient clinical effect of symptomatic treatment (antihistamine, nasal corticosteroids)
* IgE antibodies to grass and/or birch pollen antigens

Exclusion Criteria:

* severe comorbidity, severe asthma, pregnancy