cyrilzakka/clinical-trials huggingface dataset:
A Comparison of Emtricitabine and Abacavir Used in a Three-Drug Combination in HIV-Infected Patients Who Have Never Taken Anti-HIV Drugs

This study will look at whether emtricitabine is as safe and effective as abacavir (ABC) when taken with stavudine (d4T) and efavirenz (EFV) in patients who have never taken anti-HIV drugs.

Patients are randomized to receive open-label emtricitabine or ABC in combination with stavudine and efavirenz. Viral load and CD4+ cell counts are compared at Weeks 24 and 48. Patients are followed for 48 weeks.

Eligibility Criteria:
Inclusion Criteria

You may be eligible if you:

* Are HIV-positive and generally healthy.
* Have a viral load of 5,000 copies/ml or more.
* Have CD4 cell counts of 200 cells/mm3 or more.
* Are age 18 or older.
* Agree to practice sexual abstinence or use effective barrier methods of birth control (such as condoms).

Exclusion Criteria

You will not be eligible if you:

* Have ever taken anti-HIV drugs for 3 days or more.
* Have had certain AIDS-related infections.
* Have had severe diarrhea within the past 30 days.
* Are unable to eat at least 1 meal a day due to nausea, vomiting, or stomach pain.
* Are being treated for active tuberculosis (TB).
* Are pregnant or breast-feeding.
* Use illegal drugs or alcohol that make it difficult for you to take study drugs or keep clinic appointments.
* Are taking certain medications, or have certain other conditions or diseases (see the technical summary for more detail).
A Study of Efficacy and Safety of Intravenous Cefiderocol (S-649266) Versus Imipenem/Cilastatin in Complicated Urinary Tract Infections

The purpose of this study was to determine the efficacy and safety of intravenous cefiderocol (S-649266) in hospitalized adults with complicated urinary tract infections caused by Gram-negative pathogens.


Eligibility Criteria:
Inclusion Criteria:

* Hospitalized male and female patients ≥ 18 years
* Clinical diagnosis of either complicated urinary tract infections (cUTI) with or without pyelonephritis or acute uncomplicated pyelonephritis
* cUTI diagnosed with a history of ≥ 1 of the following:

  * Indwelling urinary catheter or recent instrumentation of the urinary tract
  * Urinary retention (caused by benign prostatic hypertrophy)
  * Urinary retention of at least 100 mL or more of residual urine after voiding (neurogenic bladder)
  * Obstructive uropathy
  * Azotemia caused by intrinsic renal disease (blood urea nitrogen and creatinine values greater than normal laboratory values) OR Pyelonephritis and normal urinary tract anatomy, ie, acute uncomplicated pyelonephritis AND

At least 2 of the following signs or symptoms:

* Chills or rigors or warmth associated with fever (temperature greater than or equal to 38 degrees Celsius)
* Flank pain (pyelonephritis) or suprapubic/pelvic pain (cUTI)
* Nausea or vomiting
* Dysuria, urinary frequency, or urinary urgency
* Costo-vertebral angle tenderness on physical examination AND

All subjects had to have urinalysis evidence of pyuria demonstrated by 1 of the following:

* Dipstick analysis positive for leukocyte esterase
* ≥ 10 white blood cells (WBCs) per μL in unspun urine, or ≥ 10 WBCs per high power field in spun urine

  * Positive urine culture within 48 hours prior to randomization containing ≥10\^5 colony forming unit (CFU)/mL of a Gram-negative uropathogen likely to be susceptible to imipenem (IPM)
  * Patients who were treated previously with an empiric antibiotic other than the study drugs but failed treatment, both clinically and microbiologically, were eligible for the study if they had an identified Gram-negative uropathogen that was not susceptible to the previously used empiric treatment and likely to be susceptible to IPM
  * Subjects receiving antibiotic prophylaxis for UTI who present with signs and symptoms consistent with an active new UTI

Exclusion Criteria:

* Urine culture identifies only a Gram-positive pathogen and/or a Gram-negative uropathogen resistant to IPM
* Urine culture at study entry isolates more than 2 uropathogens or patient has a confirmed fungal UTI
* Asymptomatic bacteriuria, the presence of \>10\^5 CFU/mL of a uropathogen and pyuria but without local or systemic symptoms
* Patient is receiving hemodialysis or peritoneal dialysis
Effects of Physical Therapy on Low Back Pain, Disc Height Index, Postural Stability, Disability, Gait and Function in Persons With Postero-lateral Disc Herniation

The current study aims to determine if physical therapy is significantly superior in improving postural stability, pain and function and disc height index in persons with discogenic low back pain, as compared to the standardized medical treatment.


Eligibility Criteria:
Inclusion Criteria:

* Both male and female participants
* Postero-lateral lumbar disc herniation
* Aged 18-50 years old
* Low back pain intensity less than 80/100mm on visual analogue scale or 8/10 on numeric pain rating scale
* Positive peripheralization and centralization phenomenon

Exclusion Criteria:

* Individuals with and any musculoskeletal, metabolic, or neurological disorders that may impair gait, postural stability or sensory integrity will be excluded from the study.
Dapagliflozin in the Treatment of Heart Failure

prospectively evaluation the safety and efficacy of the Sodium-glucose Cotransporter-2 (SGLT2) inhibitor dapagliflozin in non-diabetic patients with heart failure and a reduced ejection fraction

Heart failure (HF) is a complex clinical syndrome characterized by the reduced ability of the heart to pump and/or fill with blood. From a physiological point of view, HF can be defined as an inadequate cardiac output to meet metabolic demands.

HF is a growing public health problem, with an estimated 63 million people affected worldwide , with HF being the underlying cause of more than 1 million hospitalizations every year. These hospitalizations are associated with poor prognosis (50% rate of re-hospitalization within 6 months after discharge and around 33% rate of death within 12 months after discharge), In addition, the prevalence of patient with HF and reduced ejection fraction (HFrEF) is higher and has greater mortality rates than those with preserved ejection fraction (HFpEF).

Sodium-glucose Cotransporter-2(SGLT2) inhibitors are a novel class of anti diabetic agents that promote urinary glucose excretion by inhibiting glucose and sodium reabsorption from the renal proximal tubules and have recently been investigated in several large randomized controlled trials for cardiovascular safety and efficacy in patients with type 2 diabetes .

More recently, the DAPA-HF trial which showed that dapagliflozin significantly improved the outcomes of patients with HFrEF and reduced the risk of the composite outcome of CV death or the worsening of HF versus placebo by 26% irrespective of the presence or absence of T2DM, demonstrated the significance of SGLT2 inhibitors as novel therapeutic agents in heart failure.

In May 2020,The FDA approved AstraZeneca's dapagliflozin (Forxiga) for the treatment of heart failure with reduced ejection fraction (HFrEF) in adults with and without type 2 diabetes (T2D), marking the first time a drug in a class developed for diabetes was approved for heart failure even if diabetes is not present.

This study is established to investigate safety and efficacy of dapagliflozin in non-diabetic patients with heart failure.

Eligibility Criteria:
Inclusion Criteria:

* patients age \> 18 years
* Diagnosis of heart failure NYHA class II- IV
* LVEF ≤ 40% on echocardiography

Exclusion Criteria:

* Estimated glomerular filtration rate \<30 ml/min/1.73m2

  * Pregnant or lactating women
Apapitatin Combined With SOX for Palliative Adjuvant Chemotherapy in Patients With Advanced Gallbladder Carcinoma

A Single-center Open, Randomized, Controlled Study to Compare the Apapitatin Mesylate Combined With SOX Regimen and SOX Regimen for Palliative Adjuvant Chemotherapy in Patients With Advanced Gallbladder Carcinoma

The aim of the study is to observe and evaluate the progression-free survival time (PFS), overall survival time (OS) and safety of patients with advanced Gallbladder Carcinoma treated with apatinib mesylate combined with SOX

Eligibility Criteria:
Inclusion Criteria:

1. ages 18 to 75
2. UICC/AJCC gallbladder TNM staging (The eighth edition), Ⅲ B - ⅣB (excluding M1) postoperative pathological diagnosis of gallbladder carcinoma;Patients confirmed to have undergone R1/R2 cholecystectomy or palliative surgery;
3. The primary treatment is surgical resection or potentially resectable cholecystic carcinoma without other treatment
4. ECOG performance status ≤1
5. The liver and kidney function meets the following conditions： BIL\<3 normal value upper limit (ULN)；ALT and AST\< 2.5 xULN;Serum Cr≤ 1xULN,Clearance rate of endogenous creatinine\>50ml/min（Cockcroft-Gault）;
6. Other test rooms meet the following requirements:

   Hemoglobin ≥ 90 g/L (no blood transfusion within 14 days)；Neutrophilic granulocyte count \> 1.5x109 /L;The platelet count ≥ 80 x 10 \^ 9/L;
7. Estimated life expectancy \> 3 months.
8. Before the enrollment, the heart function is good. There is no episode of myocardial infarction within half a year. For example, if you have hypertension or coronary heart disease, you should ensure that it is within the controllable range.
9. Patient able and willing to provide written informed consent and to comply with the study protocol and Good compliance, with follow-up.

Exclusion Criteria:

1. Non gallbladder carcinoma
2. Significant clinical bleeding symptoms or a clear tendency to bleed occurred within the first month of randomization, such as cough/hemoptysis of 2.5ml or more, gastrointestinal bleeding, esophagogastric varices at risk of bleeding, hemorrhagic gastric ulcer, etc.
3. Other topical treatments during the study (including intraperitoneal chemotherapy, radiotherapy, etc.)
4. Pregnant or lactating women；
5. Those who suffer from high blood pressure and cannot be treated to the normal range by antihypertensive drugs；
6. HIV infection or the presence of AIDS-related diseases, or severe acute and chronic diseases;
7. Have grade II or higher myocardial ischemia or myocardial infarction、Poorly controlled arrhythmia；
8. Severe active infections；
9. There are secondary malignant tumors or other tumors within 3 years before the start of the study and there is metastasis of the brain or meninges.
10. Researchers believe that their compliance is poor
11. There are contraindications for Apatinib and S-1
The Cognitive Functioning of Young Athletes Including Bioelectrical Brain Function

The project focuses on two central issues:

1. The impact of intensity of sport on the cognitive functioning and brain waves of children in late childhood (10-12 years old);
2. The specific impact of individual forms of sporting competitions classified according to dynamic, static components as well as closed / open skill exercise. The variables will be age, gender, and fluid intelligence. Additionally, children's temperament will be examined in order to assess its relationship with the preferences for choosing a particular type of sport activity and the intensity of this activity.


Eligibility Criteria:
Inclusion Criteria:

- Polish-speaking children

Exclusion Criteria:

* mental illness;
* non-Polish speaking children
Invasive and Clinical Features in Patients With Brugada Syndrome Undergoing Catheter Ablation

This clinical trial aims to learn about the electrophysiological and clinical effects of radiofrequency catheter ablation in patients with Brugada syndrome. The main questions it seeks to answer are:

* What are the immediate effects of catheter radiofrequency ablation in cardiac electrophysiology?
* What is the relation between invasive and clinical features in patients with Brugada syndrome undergoing ablation? Researchers will compare ablation and control groups to see if there is a difference in clinical and invasive markers of the disease in one year of follow-up.

Brugada syndrome (BS) is an electric cardiac disorder characterized by a typical electrocardiographic pattern and an increased risk of cardiac arrhythmias and sudden death. Most arrhythmic events occur during rest, fever or under circumstances of increased vagal activity. In the last decade, catheter ablation has emerged as a valuable and potentially curative therapy for patients with BS. However, little is known about its mechanisms or long-term effects on clinical and invasive markers. This prospective, single-centre, randomized, sham-controlled, and masked pilot study will investigate the impact of catheter ablation in 20 patients with Brugada syndrome, who will be randomized to ablation or control group, with a 1:1 allocation ratio and clinically followed for 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a type 1 Brugada ECG pattern, as characterized by ST-segment elevation (≥2mm) with upward concavity associated with T-wave inversion, in at least one of the right precordial leads, positioned at the second, third or fourth intercostal space, either spontaneously or induced by a provocative test with Class I anti-arrhythmic drugs according to Vaughan Williams
* Patients clinically stable for at least six months before the enrollment
* Able to cope with follow-up visits up to one year after the intervention
* Patients who have signed the written informed consent

Exclusion Criteria:

* Pregnant women
* Patients with structural heart disease
* Patients with a known cardiac or systemic autonomic disorder
* Patients with a history of previous right ventricular outflow tract ablation
Effect of Co-morbidities on the Development of Oral Feeding Ability in Pre-term Infants

The aim of this study is to investigate the effect of co-morbidities on the timing of the achievement of full oral feeding in a cohort of pre-term infants and to evaluate their mode of feeding and feeding status at the time of hospital discharge.

It is widely acknowledged that pre-term infants frequently experience difficulties in attaining independent oral feeding, thus delaying the achievement of an adequate nutritional status and hospital discharge which - according to the American Academy of Pediatrics- requires the ability to feed exclusively by mouth(1-2) The development of oral feeding ability in pre-term infants is therefore a primary concern for neonatologists.

Because of the immaturity of their body functions and the occurrence of co-morbidities, pre-term infants generally require a period of enteral feeding before they acquire the coordinated sucking ability that allows sufficient milk intake for growth(3) Furthermore, infant sucking skills differ between bottle- and breastfeeding (4), and pre-term infants have been reported to show a weaker and less coordinated suck (5).

Few studies have investigated the timing and effect of co-morbidities on the achievement of independent oral skills. Jadcherla et al. (6) reported that infants born with a gestational age of \< 28 weeks showed a significant delay in attaining the transition to oral feeding, but it has also been found that the occurrence of morbidities negatively correlates with postmenstrual age at the time of achieving oral feeding skills (6),(7-8).

Eligibility Criteria:
Inclusion Criteria:

1. A randomised sample of all newborns whose gestational age of \< 37 weeks .
2. infants who will be admitted to the NICU of Assiut University Children Hospital between 1 May and 31 October 2021.

Exclusion Criteria:

1. known congenital and/or chromosomal diseases.
2. death during hospitalisation, or transfer to another institution.
Pharmaceutical Care and Clinical Outcomes for the Elderly Taking Potentially Inappropriate Medication

The investigators propose that clinical pharmacist interventions would reduce the rate of adverse drug events in elderly patients taking potentially inappropriate medication.


Eligibility Criteria:
Inclusion Criteria:

* Hospitalized patients aged at least 65 years
* Taking at least six prescribed medicines regularly, including at least one potential inappropriate medication

Exclusion Criteria:

* Patients who refused informed consent
* Discharged before consent could be obtained
* Cognitive impaired
Hypertensive Treatment and Epidemiological Analyses

To determine the impact of the treatment of hypertension on the epidemiological analyses of blood pressure from observational studies.

BACKGROUND:

With the use of antihypertensive medication increasing steadily over the last 25 years, treatment for hypertension is now common. Given the high prevalence of treatment for hypertension, researchers can no longer assume that participants in epidemiologic studies represent natural blood pressure measures, as opposed to treated blood pressure measures. The effect of this high prevalence of treatment, however, has not been fully investigated. Although it might seem that studies of "natural history" are no longer relevant, great interest currently exists in establishing both environmental and genetic determinants of blood pressure. Additionally, there currently is a renewed interest in refining treatment guidelines. For example, the need to account for absolute as well as relative risk has been hotly debated in recent years. The need will continue to exist, therefore, to analyze observational data sets to meet the evolving interest in the determinants of blood pressure and to meet the requirements for more refined risk estimates.

DESIGN NARRATIVE:

To investigate the effect of blood pressure treatment on the analysis of epidemiologic studies, the investigators conducted two interrelated analyses using simulation studies and data from five observational studies: The Framingham Heart Study; the NHANES I, II, and III cohorts; and The International Collaborative Study of Hypertension in Blacks (ICSHIB). They first conducted simulation studies to examine the behavior of different methodologies in each of two common analytic settings: relating body mass index to level of systolic blood pressure and relating level of systolic blood pressure to coronary heart disease mortality. They planned to use the data from the five studies to derive the parameters for use in the simulation studies. In these studies they quantified the level of bias that results from ignoring the presence of blood pressure treatment in observational data. After conducting their simulations studies, they repeated the analysis of the relationship between body mass index and systolic blood pressure using available empirical data.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
Optimized Diffusion-Weighted Imaging for the Evaluation of Post-Treatment Squamous Cell Carcinoma in the Neck: Comparative Study With FDG PET/CT

The investigators propose a longitudinal study evaluating post-treatment changes in patients with squamous cell carcinoma (SCC) of the neck using an innovative optimized diffusion-weighted imaging (DWI) pulse sequence to identify more accurately recurrent tumors as well as early non-responders to therapy.


Eligibility Criteria:
Inclusion Criteria:

* Histologically-proven newly diagnosis or recurrence as indicated by tissue diagnosis of T3 or T4 squamous cell carcinoma of the head and neck
* Must have had or be scheduled for standard-of-care surgical resection, radiation, and/or chemo-radiation of the diagnosed squamous cell carcinoma of the head and neck
* At least 18 years of age
* Patient must be able to understand and willing to sign a written informed consent document.

Exclusion Criteria:

* Contraindications to MRI, including:

  * MRI-incompatible implantable devices
  * severe claustrophobia; and
* Pregnant and/or breastfeeding, with women of childbearing potential having a negative urine or serum pregnancy test
The Visceral Analgesic Effect of Erector Spinae Plane Block in Laparoscopic Cholecystectomy

The purpose of this study was to investigate the effectiveness of erector spinae plane block on postoperative visceral pain in laparoscopic cholecystectomy (LLC). Given that rectus sheath block may provide sufficient somatic pain block, investigators aimed to investigate whether erector spinae block is effective in visceral pain block.

After induction of general anesthesia, group of patient is decided randomly. In Group R, rectus sheath block is performed with 0.2% Ropivacaine 30ml before the operation. In Group RE, rectus sheath block and erector spinae plane block are performed with 0.2% ropivacaine 70ml before the operation.

NRS score measurement and comparison of the rescue analgesic dose used at 0, 0.5, 1, 2,6, 12, 18, and 24 hours after arrival at the recovery room were collected


Eligibility Criteria:
Inclusion Criteria:

1. adults between the ages of 20 and 80
2. scheduled laparoscopic cholecystectomy patient
3. American society of anesthesiologists score 1 or 2
4. Patients who have voluntarily agreed in writing to participate in the trial

Exclusion Criteria:

1. Patient with side effects on local anesthetics or steroids
2. Patient who are taboo of peripheral nerve block such as blood clotting disorder, infection, etc.
3. Patients with uncontrolled medical or psychiatric problem
4. Patient does not agree to participate in the study
5. Patients with deformity at vertebra or chest wall.
6. Patients who are pregnant or lactating
7. Patients receiving a single laparoscopic cholecystectomy (including using a robot)
8. Patients with severe intraperitoneal adhesion (higher than Nair s grade 3), or with external drain.