cyrilzakka/clinical-trials huggingface dataset:
Using Microbial Genomics to Elucidate the Source of Central-line Associated Bloodstream Infections

Central line-associated bloodstream infections (CLABSIs) are the most common healthcare-associated infection in children and are associated with morbidity and mortality. This study will attempt to identify the source of bloodstream infections (BSIs) in children with CLABSI because we hypothesize that many of the BSIs that are currently classified as CLABSIs are actually laboratory-confirmed bloodstream infections (LCBI) that may be a result of mucosal barrier injury (MBI), also known as MBI-LCBI. In order to study this, we will isolate bacteria from multiple body sites of children that have BSI in order to compare these bacteria to the strain growing in their blood using whole-genome DNA sequencing. We will also evaluate biomarkers of MBI of the respiratory tract and GI tract.

This is a prospective cohort pilot study at Boston Children's Hospital (BCH) that will explore the source of presumed CLABSI, which we believe may actually have multiple possible sources including MBI. We plan to enroll all inpatient children at BCH who meet the Centers for Disease Control and Prevention (CDC) definition of MBI-LCBI as well as children who meet the criteria for CLABSI without MBI. For all enrolled patients, we will collect samples from the oral cavity, respiratory tract, skin, and stool. These samples will be cultured in order to see if the same microbial species and strain(s) growing from the blood also grow from these other sites. Cultures will then have isolated colonies selected for whole-genome DNA sequencing to allow assessment of genomic diversity between body sites. Stool and blood samples will be tested for markers of MBI. All patient enrollment and sample collection will be done at BCH.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized at Boston Children's Hospital
* Central venous catheter of any type including peripherally inserted central catheters (PICC) in any location.
* Laboratory-confirmed bloodstream infection (LCBI) diagnosed by a clinical blood culture growing certain Gram-negative rods

Exclusion Criteria:

* Patients with CDC-defined secondary bloodstream infections
Prevention of Urinary Incontinence After Prostatectomy

Urinary incontinence is a frequent complication after radical prostatectomy. Rehabilitative treatments are frequently utilized to reduce incontinence. However, their efficacy has not been completely investigated. In this study the investigators will compare the effect of an early rehabilitation programme (instruction of the patient, pelvic floor muscle training, electrical stimulation and biofeedback) versus instruction of the patient only.

The investigators hypothesis is that early rehabilitation programme is more effective than patient's instruction alone in preventing urinary incontinence after radical prostatectomy.


Eligibility Criteria:
Inclusion Criteria:

* men who will undergo radical prostatectomy for prostatic cancer

Exclusion Criteria:

* previous urinary and/or faecal incontinence
* neurologic bladder
* previous pelvic surgery
Canadian Study of Prediction of Risk and Evolution to Dialysis, Death and Interim Cardiovascular Events Over Time

This study will follow 2500 prevalent Chronic Kidney Disease (CKD) patients with Glomerular Filtration Rate (GFR) from 15-45 ml/min for 30 months with serial measurements every 6 months and subsequent annual chart review up to 60 months. This observational study will analyze the demographics, clinical status, medications and blood and urine samples of these patients and study the conventional biochemical, hormonal and metabolic parameters assessing which underlying biomarkers reflect the processes involved with disease progression.


Eligibility Criteria:
Inclusion Criteria:

* Patients currently seen by a nephrologist, or referred for evaluation of CKD
* GFR between 15-45 ml/min
* Adults 19 years (depending on age of consent in province) or older
* At pediatric sites study participants will be eligible to participate at age 15 or older

Exclusion Criteria:

* Organ transplant recipient
* Life expectancy less than 12 months
* Acute Vasculitis
* Bioimpedance sub-study exclusion criteria:
* Amputation (readings are inaccurate)
* Any battery operated or electronic implanted device (such as pacemaker or implanted defibrillator - potential electrical hazard)
* Pregnant women
Prevalence of Temporomandibular Joint Disorders Among Egyptian University Undergraduate Students

This study will take place in Egypt. Undergraduate students from different faculties of the Egyptian Universities will participate. The study began in December 2020.

Matching criteria and allocation ratio: The planned study a single arm cross sectional study, in which the prevalence of students of TMD will be reported. The association between TMD and other variables will be also studied. Therefore, no matching criteria or allocation ratio are required.

Variables It has been shown from literature that many variables are associated with TMD. It was therefore, decided to study the correlation between these variables with TMD among Egyptian population via a regression model once the assumption for regression analysis are satisfied. Binary variables are analyzed through logistic regression, while continuous data through a multivariable regression analysis. If one of the assumptions for regression analysis is violated, a subgroup analysis for each variable will be considered.

These Variables include gender, age, psychological stress, oral habits, parafunctional activities as gum chewing, previous dental treatments , previous trauma to jaws.

Data sources and management Data sources, the answered questionnaires and subsequent spread sheets will only be shared by the team members.

Addressing potential sources of bias Selection bias: an email will be sent to all the students through their university email addresses. Due to the COVID-19 situation only convenient sampling could be used. whenever possible printed questionnaires are handed to the students.

Quantitative variables: Handling of quantitative variables in the analyses None of the data is a continuous variable. All exposure factors are binary or categorical data. Therefore, no plans are set for simplifying continuous data or converting them into binary ones.

Eligibility Criteria:
Inclusion Criteria:

1. -Undergraduate students in Egyptian universities
2. Age ranges from 18-45 years
3. Males and females

Exclusion criteria

1. school students
2. students not living in egypt
Resistance and Cardiorespiratory Time-matched Exercise in Youth: A Randomized Clinical Trial (RCT:RCT)

The current epidemic rate of childhood obesity is a leading health concern as overweight/obese youth may suffer from comorbid conditions, once considered exclusive to adults. It has been suggested that physical inactivity is a major determinant of obesity and obesity-related health risk in children and adolescents. Recent studies in adults report that the combination of aerobic and resistance exercise is a better strategy than aerobic or resistance exercise alone for reducing risk factors for type 2 diabetes. Currently, the most effective exercise modality for concurrent reductions of adiposity, in particular abdominal fat, and risk factors for type 2 diabetes and cardiovascular disease (CVD) is unknown in adolescents. Therefore, we will employ a randomized trial to examine the effects of a long-term aerobic exercise, resistance exercise, and a combination of both exercise regimens on: 1) in vivo insulin sensitivity, glucose tolerance and risk for type 2 diabetes, 2) total adiposity, skeletal muscle mass, visceral adiposity and ectopic fat in the liver and skeletal muscle, and 3) traditional and non-traditional risk factors/markers for CVD in overweight boys and girls. We will recruit 168 sedentary overweight (BMI \>85th percentile) adolescent boys and girls aged 12-17 years old and randomly assign them to one of three 6-month intervention groups (n = 56 each group): 1) aerobic exercise (180 min/week), 2) resistance exercise (180 min/week), or 3) aerobic and resistance exercise (180 min/week) group. A weight maintenance diet (55-60% carbohydrate, 15-20% protein, and 25-30% fat) will be prescribed and monitored for all groups, so that any changes in energy balance will be induced by exercise intervention alone (e.g., no calorie restriction). We believe that this proposed application will have a significant implication that is directly relevant for one in three American adolescents who are at increased risk of developing obesity-related co-morbidities.


Eligibility Criteria:
Inclusion Criteria:

Age 12-17 years

* BMI percentile for age and sex \>-85% percentile and BMI \<40 kg/m2
* No structured physical activity in the past 3 months prior to the study (not including school physical education classes)
* No significant weight changes (\>2-3 kg/m2) in the past 3 months prior to the study

Exclusion Criteria:

* Endocrine disorders (e.g., polycystic ovary syndrome, diabetes)
* Syndromic obesity
* Positive pregnancy test
* Use of chronic medications which influence glucose metabolism and body composition
* Chronic medical/psychiatric conditions preventing the ability to participate in the study.
* Anemia
Home-based Physical Trainings for Reducing Cardiovascular Risk

Prospective intervention study among metabolic syndrome patients, investigating the effects of 12 weeks home-based physical training programme with telemonitoring on the anthropometric parameters, the exercise tolerance and other cardio-metabolic risk factors of the metabolic syndrome.

Prospective intervention study among metabolic syndrome patients, investigating the effects of 12 weeks home-based physical training programme with telemonitoring on the anthropometric and laboratory parameters, the exercise tolerance and other cardio-metabolic and other psycho-social (anxiety, depression, vital exhaustion , sleep disturbances) risk factors of the metabolic syndrome.

Eligibility Criteria:
Inclusion criteria:

* voluntary patients aged between 25 and 70 years
* low level of regular physical activity, less than 30 min./ week
* basic IT skills
* 3 risk factors present out of the 5 metabolic risk factors from the followings:

  1. waist circumference (WC) above 102 cm in men and above 88 cm in women
  2. proved type 2 diabetes mellitus (T2DM) or fasting plasma glucose level above 5,6 mmol/l
  3. treated hypertension or spontaneous blood pressure higher or equivalent than 130/ 85 mmHg
  4. treated hypertriglyceridaemia or serum triglyceride level above 1,7 mmol/l
  5. serum HDL cholesterol level under 1,03 mmol/l in men or 1,3 mmol/l in women

Exclusion Criteria:

* any upcoming planned invasive cardiological intervention
* uncontrolled hypertension
* type one diabetes mellitus (T1DM)
* T2DM which needed more than 1 dose insulin per day
* chronic heart failure
* chronic renal failure
* serious cognitive disfunction
* lack of cooperation
* any of known disease or condition that seriously affect the mental and legal capacity
* any other conditions inhibiting regular physical trainings
Assessment of the Impact of a Coenzyme Q10 Supplementation on the Skin

Objective of the study is to determine the influence of dietary supplementation with coenzyme Q10 (CoQ10) on skin conditions. 33 healthy female subjects will be randomly assigned to a placebo group, a low-dose (LD) group receiving 50 mg CoQ10/day and a high-dose group (HD) receiving 150 mg CoQ10/day (11 subjects per group). A water-soluble form of CoQ10 with improved bioavailability (Quvital syrup with Q10vital®, Valens Int. d.o.o., Slovenia) will be used. Various skin parameters will be evaluated before the supplementation (the baseline), after 6 and after 12 weeks of supplementation. To evaluate the photoprotective potential of CoQ10 the minimal erythema dose (MED) will be determined before (the baseline) and after 12 weeks of the supplementation.

Objective of the study is to determine the influence of dietary supplementation of CoQ10 in form of water-soluble Q10vital® on skin conditions. 33 healthy female subjects will be randomly assigned to a placebo group, a low-dose (LD) group receiving 50 mg CoQ10/day and a high-dose group (HD) receiving 150 mg CoQ10/day (11 subjects per group). A water-soluble form of CoQ10 with improved bioavailability (Quvital syrup with Q10vital®, Valens Int. d.o.o., Slovenia) will be used. The placebo or CoQ10 will be administered in the form of a syrup; all subjects will consume 5 mL of syrup daily for 12 weeks. The photoprotective potential of CoQ10 will be evaluated with a determination of the minimal erythema dose (MED) before (the baseline) and after 12 weeks of the supplementation. Other skin parameters will be evaluated before supplementation (the baseline), after 6 and after 12 weeks of supplementation. Comparison will be done as the mean of the individual ratios. The differences between the before-after condition will be analyzed with the statistical test of analysis of variance. In case of failure to find homogeneity in the variances the nonparametric ANOVA, the Willcoxon test, will be used. The results will be expressed as mean ± standard error for each group with a significance level of 0.05 for all the statistical tests.

Eligibility Criteria:
Inclusion Criteria:

* Signs of skin aging (mimic wrinkles/ poor skin tone/ visual dryness),
* Photoaged skin on the face,
* Expression of mimic wrinkles,
* Phototype II and III.

Exclusion Criteria:

* Allergy to ingredients of tested products
* High blood cholesterol and use of cholesterol-lowering medicines,
* Diagnosed diabetes
* Thyroid disease
* Inflammatory skin diseases,
* Regular use of dietary supplements 6 months or less before start of the study,
* Invasive rejuvenation treatments (botox injections, hyaluronic acid fillers, needle rollers, needle mesotherapy, etc.) 6 months or less prior to start of the study,
* Non-invasive rejuvenation treatments (radiofrequency, electrotherapy, ultrasound therapy, no-needle mesotherapy, etc.) 6 months or less prior to start of the study,
* The use of cosmetic products containing coenzyme Q10 6 months or less prior to start of the study,
* Gluteal hyperpigmentation,
* Expected sunbathing (also in solariums) within the study period.
Drug Use Investigation for TYKERB Tablet (All Case Investigation)

Data on the safety and efficacy of TYKERB shall be collected from the patients in order to grasp the actual conditions of post-marketing use and assess background information on the patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients with HER2 overexpressing inoperable or recurrent breast cancer

Exclusion Criteria:

* Patients with hypersensitivity to lapatinib or any components
* Pregnant women and women suspected of being pregnant
Mucinex Exploratory Cold Study

This is an exploratory, multicenter, randomized, blinded, placebo-controlled study of Mucinex in patients with colds. Patients will receive 7 days of treatment with either Mucinex or placebo. The study will assess the effects of Mucinex on sputum and cold symptoms.


Eligibility Criteria:
Inclusion Criteria:

* common cold symptoms
* meet symptom severity
* females of child-bearing potential must have negative pregnancy test and use effective birth control

Exclusion Criteria:

* chronic respiratory conditions
* significant heart, kidney, liver, or lung disease, uncontrolled hypertension or diabetes, cystic fibrosis, thyroid disorder
* pregnant or lactating
* known malignancy
* participation in any other clinical trial within 30 days of baseline
* related to another enrolled patient or persons involved directly or indirectly with the conduct of this study
Liquid Biopsy in Lung Cancer

The purpose of this study is to assess clinical utility of combined circulating tumor cell (CTC) and circulating tumor DNA (ctDNA) in the diagnosis of primary lung cancer.

The peripheral blood and tumor tissue samples are collected from the participants.CTC and ctDNA are analyzed from the blood samples.

Eligibility Criteria:
Inclusion Criteria:

* Patients with histology-proven lung cancer or a clinical suspicion of lung cancer
* Age \>=18, \< 80 years
* No previous history of cancer treatment within 5 years
* Patients who agree to participate

Exclusion Criteria:

* Patients who have been diagnosed with malignancy within 5 years
* Patients with previous history of lung cancer
* Patients who have uncontrolled coagulopathy
Vinflunine in Patients With Locally Advanced or Metastatic Transitional Cell Carcinoma of the Urothelium

The purpose of this clinical research study is to learn if vinflunine can shrink or slow the growth of the cancer or increase survival in patients with transitional cell carcinoma of the urothelium. The safety of this treatment will also be studied.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of transitional cell carcinoma of the urothelium that is locally advanced or metastatic (i.e. patients cannot be candidates for local/regional control of disease).
* Relapse or progression within 12.5 months of prior cisplatin or carboplatin containing chemotherapy regimen.
* Adequate performance status (Karnofsky greater or equal to 80).

Exclusion Criteria:

* Receipt of more than 1 prior chemotherapy regimen in any setting.
* Prior discontinuation of platinum due solely to toxicity.
* Current neuropathy greater or equal to CTC grade 2.
* Prior radiation to greater or equal to 30% of bone marrow.
* Inadequate hematologic function: ANC \<1,500 cells/mm3, Platelet\<100,000 cells/mm3.
* Inadequate hepatic function: total bilirubin \> 1.5 times ULN, ALT/AST \> 2.5 times ULN or \> 5 times ULN in case of liver metastasis.
* Inadequate renal function: creatinine clearance \<20 ml/min.
* Prior allergy to any vinca-alkaloid.
Efficacy of PERT for PEI in Unresectable Pancreatic Cancer.

- This will a be an open label, multicentre, randomized, controlled study in patients with unresectable pancreatic cancer, locally advanced or metastatic, with significant weight loss, and the tumour located in the head of the pancreas associated with dilated main pancreatic duct. Pancreatic Exocrine Replacement Therapy (PERT) in these patients will be given on top of other required therapies (best standard of care, BSC), including oncologic therapies, diabetes mellitus therapies and acid suppressants and nutritional support as appropriate. The duration of the study will be up to six months.

Consecutive patients meeting inclusion criteria and none of the exclusion criteria will be evaluated for the study. Those patients signing the informed consent for study participation will be randomized to one of the following two arms:

* The experimental arm will receive the best standard of care (BSC) and PERT (capsules containing pancreatin 35,000 Ph.U.) at a fixed dose of 3 capsules with main meals (breakfast, lunch and dinner) and 2 capsules with snacks over 6 months.
* The control arm will receive the BSC over 3 months, followed by a further 3-month open uncontrolled phase of BSC + PERT at the dose mentioned above.

All patients will receive in addition a proton pump inhibitor (PPI) bid (any PPI at standard dose is acceptable -omeprazole 20 mg, lansoprazole 30 mg, pantoprazole 40 mg, rabeprazole 20 mg, esomeprazole 40 mg) while on PERT, 20-30 minutes before breakfast and dinner.

To make the two arms comparable, patients will be stratified in two groups (locally advanced and metastatic pancreatic cancer) for randomization using computer generated random numbers.


Eligibility Criteria:
Inclusion Criteria:

1. Pathologically confirmed unresectable, locally advanced or metastatic, pancreatic cancer.
2. Tumour located in the head of the pancreas.
3. Dilated main pancreatic duct confirmed by imaging methods (CT scan, MRI and/or EUS).
4. Significant weight loss (≥5% of the usual body weight) at screening.
5. Life expectancy of at least six months at screening.
6. Signed informed consent to the study.

Exclusion Criteria:

1. Hypersensitivity to pancreatin of porcine origin or to any of the excipients.
2. Patients on neoadjuvant therapy, or in whom neoadjuvant therapy is planned.
3. Patients already on PERT.
4. Prior history of upper gastrointestinal or pancreatic surgery.
5. Short life expectancy (shorter than 6 months).
6. Patients on second line or beyond chemotherapy (those who failed with first line chemotherapy therapy).
7. Patients in whom a pancreatic stent has been placed.
8. Unsolved gastric outlet obstruction.
9. Unwillingness to participate in the study.
10. Inability to comply with the study visits and study protocol, whatever the reason.
MemFlex to Prevent Depressive Relapse

A wealth of research has demonstrated that they way in which the investigators recall our personal, autobiographical memories is influential in the course of depression. Biases in the recall of autobiographical memory occur in the midst of a depressive episode, and are shown to prolong symptoms, however these biases also remain when depression remits, and may predispose the individual towards relapse. A novel cognitive intervention, MemFlex, aims to train individuals to be flexible in their retrieval of autobiographical memories, and thereby reduce depressive relapse. Changes in memory bias may also have an effect on intermediate processes that increase risk of depression, such as rumination, impaired problem solving, and cognitive avoidance. This feasibility trial compares the effects of MemFlex and Psychoeducation in their ability to reduce memory bias and intermediate cognitive risk factors, and thereby depressive relapse, in individuals remitted from Major Depressive Disorder. Clinical outcome and process measures will be assessed immediately following completion of the intervention, at 6 months post-intervention, and at 12 months post-intervention. If encouraging, the results of this pilot trial may provide a foundation for a later phase trial.


Eligibility Criteria:
Inclusion Criteria:

* Meets criteria for Major Depressive Disorder but is currently in remission, indexed on the Structured Clinical Interview for the DSM (SCID; First et al., 1996)
* 18 years of age or older

Exclusion Criteria:

* Meets criteria for a current Major Depressive Episode, indexed on the SCID
* Meets criteria for another mood disorder (e.g., Bipolar disorder), indexed on the SCID
* Current alcohol or substance dependence, or currently experiencing psychotic symptoms, indexed on the SCID
* Experience of intellectual disability, traumatic brain injury, or other neurological condition which may impact memory recall, assessed via self-report