cyrilzakka/clinical-trials huggingface dataset:
The Effect of a Multispecies Probiotic on Reducing the Incidence of Antibiotic-associated Diarrhoea in Children.

In this trial, the investigators aim to assess the effectiveness of a multispecies probiotic consisting of 2 strains of Bifidobacterium (B. bifidum W23, B. lactis W51) and 6 strains of Lactobacillus (L. acidophilus W37, L. acidophilus W55, L. paracasei W20, L. plantarum W62, L. rhamnosus W71, and L. salivarius W24) in reducing the risk of antibiotic-associated diarrhoea in a group of children undergoing antibiotic therapy for common infections.

Certain individual probiotic strains have been proven to be effective in reducing the risk of antibiotic-associated diarrhoea (AAD). However, the effects of using multispecies probiotics remain unclear. The investigators aim to assess the effectiveness of a specific multispecies probiotic preparation (Ecologic AAD Kids) in reducing the incidence of AAD in children.

In this trial, a total of 350 children aged 3 months to 18 years, undergoing antibiotic treatment, will be randomly allocated to receive either a multispecies probiotic consisting of 2 strains of Bifidobacterium (B. bifidum W23, B. lactis W51) and 6 strains of Lactobacillus (L. acidophilus W37, L. acidophilus W55, L. paracasei W20, L. plantarum W62, L. rhamnosus W71, and L. salivarius W24) at a total dose of 10\^10 colony-forming units daily, or a placebo, from the first day of antibiotic treatment until 7 days after antibiotic cessation. The primary outcome measure will be the incidence of AAD, defined as ≥3 loose or watery stools (a score of A on the Amsterdam Infant Stool Scale for children younger than 1 year and a score of 5-7 on the Bristol Stool Form scale for children older than 1 year) in 24 hours, caused either by Clostridium difficile or of otherwise unexplained aetiology (after testing for common diarrhoeal pathogens), occurring during and/or up to 7 days after the end of the antibiotic therapy.

Eligibility Criteria:
Inclusion Criteria:

* children receiving oral or intravenous antibiotics for common infections, willing and able to start the probiotic intervention within 24 hours after the start of antibiotic intake, receiving broad-spectrum antibiotics (broad-spectrum penicillins, cephalosporins, fluoroquinolones, clindamycin).

Exclusion Criteria:

* prior use of antibiotics within the previous 4 weeks, presence of a severe or generalised infection, history of severe chronic disease (e.g., cancer, inflammatory bowel disease, tuberculosis), critical/life-threatening illness, immunodeficiency, history of pre-existing diarrhoea within the previous 4 weeks, exclusive breastfeeding, allergy or hypersensitivity to any component of the study product, tube-feeding, use of proton-pump inhibitors, laxatives or anti-diarrhoeal drugs, as well as use of a probiotic product containing L rhamnosus GG or S boulardii 14 days before and during the study.
Effectiveness of Eccentric and Concentric Strength Training in Patients With Subacromial Impingement Syndrome

The purpose of this study is to investigate and compare the effects of eccentric and concentric strength training on pain, strength, joint position sense and function in patients with subacromial impingement syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of subacromial impingement syndrome
* Complaints associated with subacromial impingement syndrome for at least 3 months
* No extra pain with 90 degree abduction-90 degree external rotation position of the shoulder
* Ability to complete the entire study procedure

Exclusion Criteria:

* Severe pain; shoulder pain is \> 7/10
* History of upper extremity fracture
* History of shoulder, cervical and thoracic surgery
* Having shoulder instability or frozen shoulder diagnosis
* History of shoulder injuries, trauma and / or shoulder symptoms requiring treatment during the last 1 year (except than subacromial impingement syndrome)
* Full-thickness rotator cuff tear
* Systemic musculoskeletal disease
* Neck and shoulder pain with cervical spine movement
* Chest deformity or scoliosis diagnosis
Radioaerossol Pulmonary Deposition Using Mesh in Normal Subjects

In vivo deposition studies of aerosol administration during noninvasive ventilation are scarce in the current literature.

We assessed 10 normal subjects in a crossover study evaluated by pulmonary scintigraphy aiming to compare radiaoaerosol pulmonary index and radioaerosol mass balance in the different compartments (pulmonary and extrapulmonary) of radiotagged aerosol administered using vibrating mesh nebulizers (VMN) and conventional jet nebulizer (JN) during noninvasive ventilation (NIV).


Eligibility Criteria:
Inclusion Criteria:

* No history of lung disease;
* Forced vital capacity (FVC) or forced expiratory volume in the first second (FEV1) higher or equal to 80% from predicted values (Pereira et al., 1992),
* No history of smoking;
* Without respiratory or cardiovascular disease;
* Ability to understand verbal commands;
* Willing to provide signed consent to participate in this study.

Exclusion Criteria:

* Pregnant;
* Were unable to tolerate NIV (Metha and Hill, 2001).
Safety and Efficacy of Two Artificial Tears in Dry Eye Subjects

This study will evaluate the safety, efficacy, and acceptability of two artificial tears compared to a currently available artificial tear in subjects with dry eye.


Eligibility Criteria:
Inclusion Criteria:

* Current use of an artificial tear at least twice daily, for at least three months prior to Day 1, on average
* Ability/agreement to wear habitual correction (glasses) during study period

Exclusion Criteria:

* Known allergy or sensitivity to the study product(s) or its components
* Anticipate contact lens wear during the study, or subject has worn contact lenses in the last six months
* Chronic use of systemic medications which may affect a dry eye condition
* Active ocular allergy or infection
* Use of Restasis® or other topical cyclosporine products within 3 months prior to Day 1
* Current use of any topical ophthalmic medications, have used within 2 weeks prior to Day 1, or are likely to use during study.
First-in-man Study of Single Ascending Dose of a New Drug for Neurological Disorders

The primary purpose of this first-in-man study is to investigate whether a new drug for neurological disorders is safe and well-tolerated when administered orally to healthy male adults


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Healthy on the basis of physical examination, electrocardiogram and laboratory tests.
* A subject who has a female partner of childbearing potential or a pregnant partner agrees to use a condom in combination with spermicide or a condom, respectively, from screening, during the entire study, and for at least 3 months after (the last) study drug intake
* Body mass index (BMI) of 18.0 to 29.9 kg/m2 (inclusive) at screening and Day -1.
* Systolic blood pressure (SBP) 100-140 mmHg, diastolic blood pressure (DBP) 50-90 mmHg, and pulse rate 50-90 bpm (inclusive), measured after 5 min in the supine position at screening and at Day -1.

Exclusion Criteria:

* History or clinical evidence of any disease and/or existence of any surgical or medical condition which might interfere with the absorption, distribution, metabolism or excretion of the study treatment
* Previous history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions
* Any cardiac condition or illness with a potential to increase the cardiac risk of the subject based on medical history, physical examination, or electrocardiogram (ECG) evaluations
* Any circumstances or conditions, which, in the opinion of the Investigator, may affect full participation in the study or compliance with the protocol
Study of Women With Acute Coronary Syndromes and Nonobstructive Coronary Artery Disease

Approximately 600,000 women are treated for acute coronary syndrome (ACS) annually in the US. ACS includes heart attack and a milder form called unstable angina. Many of these women have angiograms of which 14-39% show no "significant" coronary artery disease (CAD, cholesterol plaque accumulation in arteries of the heart). The remaining majority of women with ACS have cholesterol plaque buildup which appears severe enough on angiography to limit blood flow to the heart.

It is difficult to advise women with heart attacks and no major heart artery blockages on what to do if chest pain happens again. Additional studies are needed to find out why this sort of heart attack happens and to help doctors understand how to treat patients who have this problem in the best possible way.

Some women with heart attacks who have no major blockage in heart arteries have cholesterol plaque in the arteries of the heart cannot be seen on angiography but can be seen using a newer technique called intravascular ultrasound (IVUS). IVUS involves creating pictures of the artery walls using ultrasound (sound waves) from within the artery itself. In some women without major heart artery blockage, heart attack is caused by low blood flow due to disease of smaller blood vessels which cannot be seen on angiography or IVUS. This problem can be found using magnetic resonance imaging (MRI), which can show blood flow to the heart. MRI may also be used to show where the heart has been damaged. The pattern of damage could suggest that a heart attack in a woman, who has no badly blocked heart arteries, happened for one (or more) of these reasons or another reason.

The Study of Women with ACS and Non-obstructive CAD (SWAN) will use IVUS and MRI to help determine the reasons for heart attacks in women with no major blockages in heart arteries.


Eligibility Criteria:
Inclusion Criteria:

* women
* positive cardiac markers and/or ST elevation
* scheduled for angiography

Exclusion Criteria:

* prior diagnosis of obstructive CAD
* contraindication to IVUS and/or MRI
* use of vasospastic agent
Trial of Pemetrexed in Combined With Cisplatin for the Treatment of Advanced Breast Cancer

For patients resistant to enthrycycline and taxanes, there is no standard regimen. Pemetrexed alone had certain efficacy in treatment of advance breast cancer. Platin was also a effective drug for advanced breast cancer. The combination of these two drug may have a synergy with each other in treatment of advanced breast cancer.

combination of pemetrexed and cisplatin to treat advanced breast cancer. Previous regimen no more than 3 which including enthrycycline and taxanes(paclitaxel and/or docetaxel)

Eligibility Criteria:
Inclusion Criteria:

* 18-70 years old
* Resistant to enthracycle and taxanes
* Has measurable disease

Exclusion Criteria:

* Has more than 3 previous chemotherapy regimens
Effectiveness of Precision Spinal Cord Stimulation With Artisan Paddle Electrode

The primary objective of this study is to evaluate the acute and chronic efficacy of spinal cord stimulation using the Precision implantable neurostimulation device with the Artisan paddle electrode in patients with Failed Back Surgery Syndrome (FBSS) and associated primary or secondary back or lower extremity pain. There are significant numbers of patients with FBSS who have moderate to severe drug refractory pain. An optimal outcome will demonstrate that the Precision SCS device has significant effectiveness in reducing this pain resulting in improved quality of life and functional capacity.

The conventional implantation of the spinal cord stimulator calls for dual percutaneous leads placed in parallel at T8-T9 vertebral levels. A common problem after surgery is the migration of leads from the initial implanted site, the consequence of which is inadequate pain relief. Anecdotal reports suggest that the paddle electrode can eliminate some of the problems associated with lead migration by providing a constant distance between the parallel electrodes. Furthermore, it has been reported to provide superior pain relief and paresthesia coverage.

This study aims to evaluate pain and paresthesia coverage by placing a paddle lead. Patients invited to participate in this study will be eligible for SCS therapy and will have already selected therapy with the Advanced Bionics Precision system, independent of possible inclusion in this study.

Eligibility Criteria:
Inclusion Criteria:

* Have FBSS with moderate to severe back or lower extremity pain of at least 3 months duration, be an appropriate candidate for SCS, and have independently elected SCS therapy with the Precision system as next line therapy;
* Be 18 years of age or older;
* Be willing and able to comply with all study related procedures and visits;
* Be capable of reading and understanding patient information materials and giving written informed consent.

Exclusion Criteria:

* Have low back pain as the primary complaint;
* Have any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints;
* Have participated in any investigational drug or device trial in the last 4 weeks or plan to participate in any other study during the year.
Safety of RAD001 in Combination With Cisplatin and Etoposide in Lung Cancer Patients

This study aims to establish a tolerable dose level and regimen of RAD001 in combination with cisplatin and etoposide (standard-of-care chemotherapy) in patients with extensive stage small-cell lung cancer (SCLC) who have not previously been treated with systemic chemotherapy.


Eligibility Criteria:
Inclusion criteria:

* Patients with histologically or cytologically confirmed diagnosis of extensive disease small-cell lung cancer (ED SCLC)
* Age ≥ 18 years
* WHO Performance Status Grade ≤ 1 (ie. ability to perform normal daily functions)
* Adequate bone marrow, liver and renal function

Exclusion criteria:

* Chronic steroid treatment
* Prior treatment with chemotherapy for advanced lung cancer
* Prior treatment with mTOR inhibitors
* Active bleeding conditions, skin conditions, gastrointestinal disorders, mouth ulcers, eye conditions, chronic liver or kidney disorders, uncontrolled diabetes, infections or other severe medical conditions
* Symptomatic or uncontrolled brain metastases
* Other cancers within the past 5 years
* Pregnant or breastfeeding women

Other protocol-defined inclusion/exclusion criteria may apply.
Intervention with Weighted Blankets for Children with ADHD and Sleep Problems: Implementation and Effectiveness

The aim is to study a sleep intervention with weighted blankets in children with ADHD and sleep problems regarding 1) short- and long-term effects on sleep and health-related outcomes in comparison with standard treatment (melatonin), 2) barriers and facilitators to implementation in routine clinical practice, and 3) health-economic outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Children diagnosed with ADHD (DSM-5) and sleep problems (defined by screening instrument).
* Being a patient at child and adolescent mental health service (CAMHS) in Region Halland, Sweden.
Prevalence, Severity and Determinants of Cancer-related Fatigue (CRF) in Asian Breast Cancer Patients

There is a paucity of studies that focus on the symptom burden of cancer patients in Singapore, particularly the clinical effects of cancer-related fatigue (CRF). Knowing that early-stage breast cancer is curable, it is of paramount importance to evaluate the clinical and biological determinants of lingering symptoms in breast cancer survivors so that appropriate psychosocial interventions can be formulated.

The investigators hypothesize that variations in clinical and biological determinants contribute to different severities of CRF among Asian breast cancer patients. Through this study, the investigators aim to evaluate the prevalence and severity of CRF among Asian breast cancer patients, and to identify the biological and clinical determinants of CRF among these patients.

This will be a multicenter, prospective, longitudinal, observational study conducted at the National Cancer Centre Singapore and KK Women's and Children's Hospital. Informed consent will be obtained from participants before the investigators proceed with data collection.

The study participants will be assessed at relevant time points. Biological determinants and symptoms associated with CRF will be assessed. The associations between changes in CRF, plasma cytokines levels, serum cortisol levels, and other clinical determinants will be elucidated.

Eligibility Criteria:
Inclusion Criteria:

* At least 21 years of age
* Stage I-III breast cancer
* Chinese, Malay or Indian ethnics
* Surgical treatment has been performed
* Scheduled to receive four cycles of chemotherapy (doxorubicin/cyclophosphamide \[AC\], docetaxel/cyclophosphamide \[TC\], 5-fluorouracil/epirubicin/cyclophosphamide \[FEC\]) (total duration of 3 months) and/or radiotherapy and/or hormonal therapy
* No prior history of chemotherapy and/or radiotherapy
* Able to read and understand either English or Mandarin

Exclusion Criteria:

* Physically or mentally unable to provide verbal/written consent
* Symptomatically ill (such as infection or an allergic reaction to chemotherapy)
* Presence of another condition for which fatigue is a prominent symptom (e.g. AIDS, fibromyalgia, or rheumatoid arthritis)
* Newly started on any medications that can cause general fatigue and body weakness (e.g. a beta-blocker or antidepressant, antihistamine, or antipsychotic medication)
* Presence of neurologic or immune-related medical condition or behavior known to influence the immune system (e.g. smoking or heavy drinking)
The Effect of Obesity on Recovery Profile in Children

It is planned to investigate whether obesity affects the recovery profile after anesthesia in pediatric patients. To evaluate recovery profile, time to spontaneous ventilation (the time between anesthetic discontinuation and beginning of spontaneous ventilation), LMA removal time (the time between anesthetic discontinuation and LMA removal), open eyes (the time between anesthetic discontinuation and eye opening in response to verbal stimulus or painful pinching), and PACU discharge will be also noted.


Eligibility Criteria:
Inclusion Criteria:

* ASA physical status I and II
* Routine surgery under general anesthesia

Exclusion Criteria:

* Any known cerebrovascular disease
* Long- or short-term (within the previous 24 hours) intake of any drug acting in the central nervous system
* The patients bypassing the recovery room
Prognostic Role of the Uremic Toxin Indoxyl Sulfate on Vascular and Cardiac Functions During Acute Kidney Injury

Acute kidney injury (AKI) is a frequent disease in conventional hospital departments and in intensive care units. It's associated with a high risk to develop chronic kidney disease (CKD), even after a single small AKI episode. It's also associated with an important morbi-mortality, particularly cardiovascular (CV). Some studies have already showed a link between AKI and CV risk but pathologic mechanisms implicated are still unknown. In AKI and CKD, numerous substances, called uremic toxins (UT) are accumulating in blood. In CKD, those toxins, and particularly Indoxyl sulfate (IS), are known to have cardiac and vascular deleterious consequences. However, in AKI, whether acute accumulation of UT may trigger CV complications is unknown.

The purpose of this study is that during AKI, a high UT concentration, in particular IS, would be associated with early vascular and cardiac dysfunctions that can be characterized by the persistence of an accelerated pulse wave velocity (PWV). The main objective is to evaluate the correlation between UT concentrations (especially IS) and arterial stiffness (PWV measurement) at three months of an AKI episode in conventional hospital departments and in the intensive care unit of nephrology.


Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years old.
* Patients hospitalized in conventional hospital departments and in intensive care units of nephrology.
* Patients with moderate to severe AKI (KDIGO 2 or 3) without dialysis.
* AKI from functional or organic aetiology

Exclusion Criteria:

* Patients with severe CKD (GFR\<45ml/min/1.73 m2) or with kidney transplants.
* Patients with AKI from septic or obstructive aetiology.
* Patients with AKI from toxic aetiology whose toxic would be also responsable of cardia toxicity.
* Patients with sepsis or blood inflammation.
* Patients with severe chronic cardia dysfunction.
* Patients with arrhythmia or complete heart block.
* Patients with peripheral artery occlusive disease.
* Pregnancy.
* Patients on palliative care.
Identifying Genes That Predict Risk of Developing Cervical Intraepithelial Neoplasia or Invasive Cervical Cancer

RATIONALE: Finding certain changes in genes may help doctors predict which patients are at risk of developing cervical intraepithelial neoplasia or invasive cervical cancer and may help the study of cancer in the future.

PURPOSE: This clinical trial is studying genes that may predict which patients are at risk of developing cervical intraepithelial neoplasia or invasive cervical cancer.

OBJECTIVES:

* Utilize molecular assays to identify a panel of hypermethylated genes that are predictive of cervical intraepithelial neoplasia (CIN) grade 3 or invasive cervical cancer (ICC) among patients with or without HIV infection.
* Perform a nested case-control study assessing the risk of developing CIN3 in relationship to human papillomavirus (HPV) persistence, HIV, and the presence or acquisition of candidate hypermethylated genes in these patients.
* Identify HIV-related factors (e.g., CD4 counts, viral load, and highly active antiretroviral therapy \[HAART\]) that might be associated with the presence or acquisition of specific hypermethylated genes in these patients.

OUTLINE: This is a longitudinal, multicenter study.

Patients undergo biopsy for removal of cervical tissue. Patients also undergo blood and urine sample collection. Samples are analyzed for the presence of cancer or changes that indicate that cancer might develop. Patients also undergo colposcopy at baseline and at 3 years.

After completion of study procedures, patients are followed every 4 months for up to 3 years.

PROJECTED ACCRUAL: A total of 1,150 patients will be accrued for this study.

Eligibility Criteria:
INCLUSION CRITERIA:

* Underwent Pap smear, human papillomavirus (HPV) testing, and HIV testing AND meets any of the following criteria:

  * Biopsy and colposcopy confirmed cervical intraepithelial neoplasia (CIN) or invasive cervical cancer (ICC), meeting any of the following criteria:

    * CIN grade 2-3 or higher
    * Repeated CIN1 (times 6)
    * Abnormal Pap smear (atypical squamous cells of undetermined significance \[ASCUS\] or worse)
  * HIV seropositive
  * Negative cytology but positive for high-risk human papillomavirus (HPV)
  * Negative cytology and negative HPV
  * HIV negative (without biopsy-proven CIN 3 or worse) and high-risk HPV infection (types 16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 55, 56, 58, 59, 68, 82, 83, 73)
* \>= 18 years of age
* Intact cervix
* Not pregnant
* Able to provide informed consent

EXCLUSION CRITERIA:

* \< 18 years of age
* Pregnant at screening
* Cervix not intact
* not able to provide informed consent