cyrilzakka/clinical-trials huggingface dataset:
Aminoglycoside Plasma Level Measurement in Neonates With Infection

The aim of this study is to determine whether the plasma concentration of aminoglycoside in Indonesia neonates with infection are within safe and effective range and its association with cochlear toxicity and nephrotoxicity.

Aminoglycosides are toxic antibiotics, but they are urgently needed to treat newborns with severe infections. Aminoglycosides are well known for their nephrotoxicity and ototoxicity, meanwhile the renal function of the newborns is not yet fully developed.The aminoglycoside dosage currently applied in Indonesia is derived from studies done in Caucasian populations. The safety and efficacy of this dosage regimen, however, have never been evaluated till date. The pharmacokinetic profile of drugs may vary between populations and this may be influenced by genetic factors, lifestyle, drug interactions, etc. The detection of aminoglycoside toxicity in newborns is usually problematic. The present study aims to know the proportion of nephrotoxicity and ototoxicity in newborns in the Cipto Mangunkusumo Hospital treated with gentamicin or amikacin in relation to their trough serum concentration. The serum level of gentamicin and amikacin is assumed to be safe if the trough serum concentrations are \< 2 mcg/mL and effective if its is between 5-12 mcg/mL. For amikacin the desired trough serum concentrations are \<10 mcg/mL and the peak is between 20-30 mcg/mL. The nephrotoxicity was assessed by measuring the level of kidney injury molecule-1 in urine while the ototoxicity was assessed by Distortion Product Otoacoustic Emission (DPOE) instrument.

Eligibility Criteria:
Inclusion Criteria:

* neonates with infection treated with gentamicin or amikacin

Exclusion Criteria:

* neonates who hypersensitive to gentamicin and amikacin
* neonates who also treated with other nephrotoxic drugs (vancomycin, furosemide, amphotericin B, meropenem)
Parkinson's Disease Treatment With Coenzyme Q10

The purpose of this study is to compare the effects of varying dosage of coenzyme Q10 (CoQ10) versus a placebo in the treatment of Parkinson's disease (PD) in patients with early, untreated PD.

Four groups of 20 subjects/group of subjects will be randomly assigned to receive CoQ10 (at doses of 300, 600 or 1200 mg/day) or matching placebo. A subject must have early PD that does not require treatment. A subject will be evaluated at a Screening Visit, a Baseline Visit (after which the subject begins to take the study drug) and visits at 1, 4, 8, 12, and 16 months after the baseline visit. The subject will be followed until she/he needs treatment with levodopa or for a maximum of 16 months. Because CoQ10 is a component of the mitochondria (the part of a cell that makes energy), blood samples will be taken at the baseline visit and the last visit to study mitochondrial function.

Eligibility Criteria:
Inclusion Criteria:

* The subjects must have the three cardinal features of PD: slowness of movement, resting tremor and rigidity. The signs of PD must be greater on one side.

Exclusion Criteria:

* Disorders that mimic PD.
* Other serious medical problems.
Treating Emotional Processing Impairments in Individuals With TBI

The current project will examine the impact of an emotional processing intervention on emotional processing abilities in a sample of 50 persons with moderate to severe TBI. Outcome will be assessed across 3 domains. We will document changes resulting from treatment: (1) in emotional processing tasks (2) in other areas of function including QOL, social functioning, mood and cognition that are also likely to be impacted (3) in brain structure and function. The examination of efficacy in the above three areas will further our knowledge of emotional processing deficits in TBI and more importantly, identify an effective means of treating such deficits.

Emotional processing deficits have a significant negative impact on the lives of persons with TBI. There is emerging research indicating that, in addition to cognitive and behavioral impairments, social and emotional difficulties following TBI are common and are related to significant problems in social relationships, poor social participation, impaired empathy, and a high degree of caregiver stress. Emotional processing is a critical component of social cognition, including the abilities to both identify and discriminate basic universal emotions. The stability of emotional processing deficits following TBI indicates that these impairments likely impact individuals with TBI consistently across the lifespan, and do not appear to resolve with time.

The goals of the trial are to (a) Evaluate the effectiveness of an emotional processing intervention to improve performance on tests of emotional processing in individuals with TBI, (b) Evaluate the improvement of secondary outcomes of psychological, cognitive, and functional abilities following the emotional processing intervention in individuals with TBI, (c) To examine differences in brain activation patterns during emotional processing following treatment in individuals with TBI, BOLD activation in the experimental group will be compared to BOLD patterns of the control group during performance of the QFDT, a facial affect recognition task.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of Traumatic Brain Injury (TBI)
* can read and speak English fluently

Exclusion Criteria:

* prior stroke or neurological disease.
* history of significant psychiatric illness (for example, bipolar disorder, schizophrenia, or psychosis) or a current diagnosis of Major Depressive Disorder, Schizophrenia, Epilepsy, Bipolar Disorder
* significant alcohol or drug abuse history
Effect of Health Education Intervention on Promoting Healthy Lifestyles for Undergraduate Female Students in Saudi Arabia

According to the World Health Organization (WHO), Saudi Arabia has seen a more astonishing rise in obesity. Young females have a considerable prevalence of unhealthy dietary practices and lack of knowledge about healthy and energy-dense foods. Additionally, in Saudi Arabia, the levels of physical inactivity ranged from about one-third to as high as 70% of the population. The current study aims to determine the effects of combined health education and motivational message intervention on promoting healthy lifestyles and body composition markers for undergraduate female students who suffer from obesity at Northern Border University in the Kingdom of Saudi Arabia.

A cluster randomized controlled study will be conducted among 250 undergraduate female students aged (18-24) in Northern Border University. The intervention and control faculties will be selected and allocated randomly. The intervention group will have six weeks of fortnightly six sessions (45 minutes), while the control group will have their regular curriculums and normal physical activity routine. The research instruments include socio-demographic characteristics, anthropometric measurements, and questionnaires about knowledge, attitude, and practice of obesity, physical activity, dietary intake, dietary quality, diet and eating behaviour, and disordered eating. Data will be collected from intervention and control groups at baseline, post-intervention, and 3-month follow-up after the intervention. Data will be analyzed by using the (SPSS) software version 26. Descriptive statistics will be used to distribute and summarize the data. A Generalized Estimating Equation (GEE) will be used to test the effect of the intervention program for the selected variables (outcomes) between and within the group at baseline, six weeks, and one month after intervention, which is adjusted for clustering.

Eligibility Criteria:
Inclusion Criteria:

* Female undergraduate students.
* Saudi students.
* Aged between 18-24 years.
* Categorized with a BMI greater than 25.

Exclusion Criteria:

* Pregnant students
* Students with diseases on treatment such as asthma, diabetes, cancer, cardiovascular diseases, fractures, cirrhosis, or other diseases.
* Students with any medical condition who not allowed to do physical activity.
Celiac Disease and Diabetes Mellitus

The aim of the present study is to detect Celiac Disease among suspected patients with Type 1 Diabetes Mellitus who admitted to Assiut University Children's Hospital during one year duration

Type 1 diabetes mellitus (T1DM) is an immune-mediated disease characterized by reduced insulin secretion by islet Beta cells in the pancreas that leads to insulin deficiency . Because of a common genetic background and interaction between environmental and immunological factors, Patients with T1DM are at a great risk for developing autoimmune diseases. It is well recognized that T1DM can be associated with celiac disease (CD) and autoimmune thyroid disorders (ATD). Recent studies regarding CD and T1DM have indicated that the frequency of this association can vary from 1.7% to 16% . Also other autoimmune diseases may be noted such as Addison's disease and vitiligo.

Celiac disease is an autoimmune enteropathy that is caused by permanent susceptibility to gluten (a protein found in wheat, barley, and rye) in genetically susceptible individuals .

CD develops with symptoms, such as steatorrhea, weight loss, developmental disorder, abdominal pain, and nutritional symptoms (e.g. vitamin deficiency), and is improved shortly after elimination of gluten-containing foods .

Extraintestinal signs and symptoms include iron-deficiency anemia, chronic fatigue, failure to thrive, stunted or short stature, delayed puberty, amenorrhea, recurrent aphthous stomatitis, dermatitis herpetiformis - like rash, fracture with inadequate traumas, osteopenia, osteoporosis.

Since the majority of CD patients can be asymptomatic, screening for CD at the time of T1DM diagnosis is recommended . In seronegative cases at the first screening, if there are no CD symptoms, regular screening every 2-5 years is recommended. However, in patients with CD symptoms or history of CD in first-degree relatives more frequent screening is recommended . Testing of asymptomatic CD would provide a prompt diagnosis of CD and enable better metabolic control for T1DM patients .

However, recently, some studies have shown normalization of celiac serology in patients with T1DM, even with no gluten-free dietary intervention. In the mentioned studies, spontaneous normalization developed in 20-35% of the cases

. Therefore, considering all of the serologically positive individuals as CD and giving a gluten-free diet (GFD) imposes an additional psychological burden for children and families.

In the latest European Society for Pediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) guidelines, it was highlighted that the level of anti-tissue transglutaminase-IgA (anti-TTG IgA) should be at least 10 times higher than the upper limit of normal (ULN) for diagnosis of CD without duodenal biopsy.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 Diabetes mellitus
* Symptoms and signs suggestive of Celiac disease.
* Age : 1-18 years old

Exclusion Criteria:

* No symptoms or signs suggestive of celiac disease.
* Patients who are Non CD gluten hypersensitivity
* Age : less than 1 year old.
Aerosol and Droplet Dispersion During Gastrointestinal Motility Investigations

To obtain more knowledge about the generation of aerosol and droplet dispersion and deposition during naso-gastric intubation for gastrointestinal motility investigations

Health care workers (HCW) at the endoscopy unit are at constant occupational risk for many infectious diseases as they perform daily procedures that are believed to generate aerosol and droplets, which may harvest respiratory pathogens. These daily procedures include for example High Resolution Impedance Manometry (HRiM), 24h multichannel intraluminal impedance-pH monitoring (MII-pH) and endoscopic investigations. It is well-known that these procedures may induce cough, and can generate aerosol and droplets (1). Previous research showed that respiratory pathogens can remain dispersed in aerosol for up to 3 hours and droplets with a viral load remain stable on plastic and stainless steel surfaces (2). Furthermore, it is known that high viral loads may be present in the nasal cavity, nasopharynx and the oropharynx (3). The impact of the occupational risk for HCW at the endoscopy unit was confirmed during the peak of the severe acute respiratory syndrome -coronavirus (SARS-CoV) outbreak, as confirmed in an online survey from 39 motility centers in Europe. This survey showed that 35 out of 39 centers reduced their capacity during the SARS-CoV outbreak in the month of March 2020 with a median of 100% (range 50-100%) for esophageal HRiM and with a median of 100% (range 80-100%) for MII-pH (4).

Therefore, with resumption of clinical activities during the recovery phase of the SARS-CoV outbreak, a number of guidelines and measures are taken to protect patients and personnel from viral spread. Patients are screened for SARS-CoV infection by reverse transcription polymerase chain reaction ((RT-)PCR) testing on a nasopharyngeal swab specimen prior to invasive investigations and they are required to wear a chirurgical facemask in the hospital at all times. Staff of the endoscopy and function testing units are wearing a chirurgical facemask, standard gloves, goggles, hairnet and a water-resistant gown. Moreover, patients are required to keep a surgical mask over their mouth during the naso-gastric probe positioning, and the bed is lowered so that the head of the patient is below the neck level of the technician. Throughout the procedure, the technician positions him- or herself to the side and back of the patient. However, there is a lack of scientific evidence on the amount of aerosol and droplet spread when these procedures are being performed, with the safety measures that are outlined (1, 4).

Eligibility Criteria:
Inclusion Criteria:

Aged \>18 years old;

* Male or female patients;
* Patients undergoing elective gastrointestinal motility investigations (MII-pH and HRiM);
* Negative PCR on nasopharyngeal swab 24 hours prior to the test;
* No anatomical deformity of nose and throat, no known diseases of nose and throat;
* Signed informed consent.

Exclusion Criteria:

* Females who are pregnant or lactating;
* Use of anticoagulant medication;
* Known allergy to fluorescein.
Xerostomia-optimised IMRT Versus Standard IMRT in NPC

This is a multi-center, non-inferiority, open-label, randomized controlled phase III clinical trial in primary diagnosed nasopharyngeal carcinoma (NPC) patients without distant metastasis. This study aims to compare the regional control, survival outcomes, radiation-related toxicities, and quality of life (QoL) of xerostomia-optimized intensity-modulated radiotherapy versus standard intensity-modulated radiotherapy in NPC patients

Xerostomia remains one of the most common radiation-induced toxicities, and approximately 80% to 90% of NPC patients still experience varying degrees of xerostomia post-IMRT. Among the major salivary glands, the parotid gland is the largest and produces 60% to 65% of the oral saliva output. Studies have revealed that xerostomia post-IMRT is mainly dependent on the irradiation dose of the parotid glands. Clinical target volumes (CTV) for the cervical nodal region starting from skull base have been the standard in nasopharyngeal carcinoma for several decades. Consequently, the parotid glands overlap with the target volumes and irradiation dose reaches 31.7 Gy to 43.9 Gy in most reports. Retrospective studies reveal that the lateral process of C1 is a suitable cranial edge for neck CTV delineation; therefore, the volume of the parotid glands exposed to high radiation doses can be greatly reduced. we conducted this trial comparing outcomes ,toxicities and QoL of xerostomia-optimized intensity-modulated radiotherapy versus standard intensity-modulated radiotherapy in nasopharyngeal carcinoma.

Eligibility Criteria:
Inclusion Criteria:

* Newly histologic diagnosis of nasopharyngeal non-keratinizing carcinoma (WHO II/III);
* All genders, range from 18-70 years old;
* ECOG score 0-1;
* Clinical stage I-IVa (AJCC/UICC 8th);
* Not received radiotherapy, chemotherapy and other anti-tumor treatment (including immunotherapy);
* No contraindications to chemotherapy or radiotherapy;
* Adequate organ function: white blood cell count ≥ 4×109/L, neutrophile granulocyte count ≥ 1.5×109/L, hemoglobin ≥ 90g/L, platelet count ≥ 100×109/L; alanine aminotransferase or aspartate aminotransferase \< 2.5×upper limit of normal; blood urea nitrogen or creatinine ≤ 1.5×upper limit of normal or endogenous creatinine clearance ≥ 60ml/min (Cockcroft-Gault formula);
* Sign the consent form.

Exclusion Criteria:

* Level II involvement with extracapsular extension (ECE), and/or had a maximum nodal axial diameter (MAD) of greater than 3cm in level II ;

  -≥4 nodal regions of ipsilateral neck involvement;
* Radiologically suspicious or confirmed involvement in level II area between skull base and the lateral process of C1;
* Parotid lymph node and/or parotid gland involvement;
* History of parotid disease or surgery;
* Previous malignancy or other concomitant malignant disease;
* Pregnancy or lactation.
The Effect of a Non-hormonal Cox-2 Inhibitor (Celebrex) on Ovulation

The purpose of this study is to assess the effect that Celebrex (a COX-2 inhibitor and non-steroidal anti-inflammatory drug) has on ovulation.

A prospective randomized double-blind crossover study of healthy reproductive-aged (18-35 years old) women with regular cycles, not currently using or needing hormonal contraception, were recruited. Women will undergo ovarian ultrasound and serum hormone monitoring during four menstrual cycles (control cycle, treatment cycle 1, washout cycle, treatment cycle 2). Subjects received study drug (oral celecoxib 400 mg or placebo) either 1) once daily starting on cycle day 8 and continuing until follicle rupture or the onset of next menses if follicle rupture did not occur (pre-LH surge dosing) or 2) once daily beginning with the LH surge and continued for 6 days (post-LH surge dosing). Women will be randomly assigned to one of the above treatment schemes and received the other in the subsequent treatment cycle.

This study aims to determine if treatment with a highly selective COX2 inhibitor, celecoxib, would be a more effective agent in terms of causing ovulatory dysfunction. This study also aims to determine whether treatment with celecoxib would adversely affect luteal function.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-35
* Currently NOT using hormonal contraception
* Cycle length between 26-34 days
* General good health (specifically no hx of: diabetes, cardiac problems, moderate/severe heart burn (GERD), obesity (BMI \> 30), hypertension (BP \> 130/80)
* Willing and able to agree to randomization and informed consent
* Willing and able to use a menstrual diary to chart bleeding Serum progesterone \> 3 ng/ml (from cycle day 18-25)
* Willing and able to return to clinic for bi-weekly for blood tests and ultrasounds throughout cycles 2, 3 \& 5

Exclusion Criteria:

* Diabetes
* Cardiac disease
* Moderate to severe heart burn (or GERD) Obesity (BMI \> 30) Hypertension (BP \> 130/80)
* Allergy to NSAIDS
* Currently pregnant or trying to conceive
* Polycystic Ovarian Syndrome
* Use of hormonal contraception (participants can use barrier methods, spermicide, female or male sterilization, copper intrauterine device, abstinence, or have female partners
Gonorrhea and Chlamydia HIV-infected Men Who Have Sex With Men

This study will estimate the rates of asymptomatic Chlamydia and/or Gonorrhea in the oropharynx, rectum and urethra (urine) of HIV infected men who have sex with men at a specialty care center and compare it to the rates in Douglas County, using nucleic acid amplification tests.

Hypothesis: Men who have sex with men (MSM) are at higher risk for sexually transmitted diseases. Currently, free testing for sexually transmitted diseases is only being performed in urine samples. Investigators hypothesize that the rates of both gonorrhea and chlamydia will be higher when testing includes more than one anatomical site (rectum and oropharynx).

The aim of the study is to estimate the rates of asymptomatic Chlamydia and/or Gonorrhea in the oropharynx, rectum and urethra (urine) of HIV infected men who have sex with men at the specialty care center of the University of Nebraska Medical Center and compare to the rates in Douglas County, using nucleic acid amplification tests.

Eligibility Criteria:
Inclusion Criteria:

* HIV infection
* Men with history of sex with men (including transgender and bisexual)
* Older than 19 years of age
* Asymptomatic at the time of visit.

Exclusion Criteria:

* Active sexually transmitted disease symptoms in the oropharynx.
* Recent treatment for Chlamydia or gonorrhea within 3 weeks.
* Treatment with antibiotics active for Chlamydia or gonorrhea within the last 2 weeks: doxycycline, quinolones and azithromycin, and cefixime.
* Women.
* Inability to complete the questionnaire in English or Spanish.
SOFA: Study on Omega-3 Fatty Acids and Ventricular Arrhythmia

The objective of the SOFA trial is to investigate whether supplemental intake of n-3 polyunsaturated fatty acids (n-3 PUFA) from fish oil can reduce the recurrence of life-threatening ventricular arrhythmias in patients with an implantable cardioverter defibrillator (ICD).

Previous human observational studies and clinical trials provide strong indications that n-3 PUFA from fish can prevent cardiovascular disease. Striking is that these studies show a strong relation between n-3 PUFA and sudden death, but not between n-3 PUFA and non-fatal heart disease. Sudden death is one of the most common and often the first manifestation of coronary heart disease. The majority of sudden deaths are directly caused by acute ventricular arrhythmia. Our hypothesis is that n-3 PUFA prevents sudden death by suppressing life-threatening cardiac arrhythmia. Therefore, we investigate in a randomized controlled clinical trial whether supplemental intake of n-3 PUFA from fish can reduce the incidence of life-threatening cardiac arrhythmias. Our population consists of patients with an implantable cardioverter defibrillator (ICD), because this device records all arrhythmic events in a memory chip. As the ICD enables continuous monitoring of events in nonhospitalised patients, this population is very suitable for testing a possible antiarrhythmic effect of n-3 PUFA. The objective of the SOFA trial is to investigate the effect of fish oil on the incidence of recurrent ventricular arrhythmia in patients with an ICD. The SOFA is a randomised, parallel, placebo-controlled, double-blind intervention study which is currently being carried out in 26 cardiology centers in Europe. Five hundred forty six patients with an ICD are randomised to receive either 2g/d of fish oil or placebo oil for a period up to 12 months. The primary outcome is spontaneous ventricular tachyarrhythmias as detected by the ICD or all-cause mortality within 12 months.

Eligibility Criteria:
Inclusion Criteria:

* ICD is capable of recording ECG strips for at least 10 of its (attempted) therapeutic interventions
* 18 years or older
* written informed consent

Exclusion Criteria:

* Primary prophylactic indication
* ICD implantation as a 'bridge' to heart transplantation
* Refractory supraventricular arrhythmias with rapid ventricular rates despite antiarrhythmic therapy
* a projected lifespan of less than 1 year
* participation in another trial (during or within 30 days before SOFA)
* use of any supplemental n-3 fatty acid during the last 3 months
* intake of more than 8g of n-3 fatty acids from fish per month as judged by a fish frequency questionnaire
* pregnant women and women of childbearing potential who do not use adequate contraception
* patients known to have a history of recent drug or alcohol abuse