cyrilzakka/clinical-trials huggingface dataset:
Zinc Resistant Starch Project

Broad - to examine the result of feeding RS to 3-5 year old rural Malawian children on zinc homeostasis and environmental enteropathy (EE).

Specific -

1. To measure zinc status using a dual zinc stable isotope assay before and after administering resistant starch (RS) in 20 children.
2. To measure intestinal function using a site-specific sugar absorption test before and after administering RS in 20 children.
3. To determine the relationship between RS and zinc homeostasis.
4. To determine the relationship between RS and environmental enteropathy.

A total of 20 (10 M, 10 F) stunted rural Malawian children aged 36-60 months will be studied to determine if there is an effect of feeding RS on zinc homeostasis and environmental enteropathy. These children are at high risk for zinc deficiency and environmental enteropathy by their demographic characteristics. Children will first have a quantitative assessment of zinc homeostasis where each child is given 2 zinc stable isotopes, one by mouth and another intravenously, which is followed by a stool and urine collection of 4 days. Zinc isotopes are quantified in the feces and urine, and these values are used to calculate the primary outcome, net zinc balance. This is followed by an assessment of environmental enteropathy quantitatively measured using the non-invasive site specific sugar absorption test, where each child drinks 100 mL of a sugar solution and a urine collection follows. The quantities of non-metabolizable sugars are measured, and the ratio of two of the sugars, lactulose and mannitol, is a measure of environmental enteropathy. Then the children will receive a dietary supplement, corn starch that has been modified to reduce its dietary absorption, for 5 weeks, which they will add to their phala. The RS is a standard food product that has been used safely in many millions of people for several decades. After taking this RS for 4 weeks both the zinc stable isotope test and the dual sugar absorption test will be repeated on the children to see if they have improved. These results will offer preliminary data as to whether RS might be used effectively on a large scale in the community to alleviate zinc deficiency and/or environmental enteropathy.

Eligibility Criteria:
Inclusion Criteria:

* Any stunted, otherwise healthy child aged 36-60 months living close to the Chipalonga Health Center. Stunting will be defined as height-for-age Z-score (HAZ) \< -2. Children will be selected on the basis of having the lowest weight-for-height Z-scores (WHZ), and by dietary surveys on which their caretakers report consuming animal source foods \< twice per month. Previous field work indicates about 80% of children are stunted and almost all children consume animal source foods \< twice per month.

Exclusion Criteria:

* Children who are not permanent residents in the village. Additionally, children with severe chronic illness such as cerebral palsy, and those who are receiving other supplementary food, or those who are participating in another research study are all ineligible to participate.
Fructo-oligosaccharides and Irritable Bowel Syndrome

Fructo-oligosaccharides are known as prebiotic ingredients to modulate the composition of the intestinal microbiota and particularly to stimulate the growth of Bifidobacteria. Imbalance of the intestinal microbiota such as reduction of Bifidobacteria is implicated in Irritable Bowel Syndrome (IBS). Thus the objective of the study is to evaluate the effect of fructo-oligosaccharides to improve IBS score and to explore which modifications of the microbiota are responsible of this improvement.


Eligibility Criteria:
Inclusion Criteria:

* IBS subjects according to Rome III criteria
* Incomfort below or equivalent to 30mmHg during Tensostat test
* between 18 and 60 years
* no antibiotic treatment for the last 2 months
* less than 20g of dietary fibres consummed per day
* no analgesic treatment
* no treatment for intestinal transit

Exclusion Criteria:

* subjects suffering from diabetes, colic cancer, inflammatory bowel disease, dysthyroidy, Hirschprung disease, anorexia
* excessive consumption of alcohol or tobacco
* participating to another clinical study
* pregnant women
* antidepressor or anxiolytic treatment
Use of Reticulocyte Ratio and Neutrophil / Lymphocyte Ratio in the Diagnosis of Ventilator-associated Pneumonia

In this study, the utility of changes in the ratio of Ret-He and NLR as an early inflammation marker for VAP will be evaluated.

Ventilator-associated pneumonia (VAP) is one of the most common nosocomial infections in the intensive care unit, affecting one third of patients requiring mechanical ventilation for a noninfectious reason. In the case of inflammation, iron retention increases in the reticuloendothelial system cells; hemoglobin (Hb) synthesis is reduced. It has been reported that the ratio of reticulocyte / hemoglobin (Ret-He) decreases in the early period in community-acquired pneumonia patients and may be a guide as a marker of inflammation. In addition, the neutrophil / lymphocyte ratio (NLR) is a parameter studied in the hemogram panel. It provides a clue to both the presence of infection and the focus of the infection.

In this study, the utility of changes in the ratio of Ret-He and NLR as an early inflammation marker for VAP will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

-Patients who need mechanical ventilation for longer than 48 hours for a noninfectious reason in the intensive care unit

Exclusion Criteria:

* Pulmonary or extrapulmonary infection before mechanical ventilation,
* severe immunosuppression,
* bleeding in the gastrointestinal system,
* using corticosteroids,
* neoplastic disease history
Texture Features and PDL1 in CT-PET 18 FDG

Search correlation between texture features in CT-PET 18 FDG and overexpression of PDL1 in non-small cell lung carcinomas during the inital staging.

The hypothesis is that overexpression of PDL1is correlated with at least one texture feature among those selected.

84 CT-PET 18 FDG at the initial staging of a non small cell lung carcinoma (adenocarcinoma or squamous cell carcinoma), whose the biopsed site was the primitive site or the drainage lymphadenopathy, without previous treatment, were recruited and analyzed by a software allowing to estimate texture features.


Eligibility Criteria:
Inclusion criteria:

* adult patient ;
* first CT-PET 18 FDG realized for the inital staging ;
* absence of previous treatment for a thoracic neoplasm ;
* biopsy realized on the primitive site or local drainage lymphadenopathy ;
* primitive site viewable with morphological imagery ;
* availability of evaluation of PDL1's overexpression ;

Exclusion criteria

- Refusal to participate in this research
Xiaxi Program for Back Health

Progressive deformity from the optimal spinal curvatures is a degenerative disorder related to progressive ageing that affects an increasing number of adults. This is one of the main affectations on the health of adults, being its cause multifactorial. That is why a totally effective intervention has not yet been found that allows obtaining a substantial improvement in all the adults who suffer from it. However, certain physical programs that include mind-body work have been effective, but research is limited and the results are inconclusive. For this reason, this research arises, in which a training protocol has been designed using an instrument called Xiaxi with which the body-mind work is prioritized.

The aims of this study were: 1) to evaluate the effects of a 12-weeks Xiaxi® exercise program on the sagittal spinal disposition and hamstring extensibility of adults, and 2) to determine whether the weekly training frequency influenced the changes found on sagittal spinal disposition and hamstring extensibility with Xiaxi® training program.

The present investigation is composed of two data collections that will be carried out before and after a twelve-week intervention. Two intervention groups and a control group make up the sample, with one of the intervention groups attending Xiaxi training once a week and the other intervention group twice a week. The control group will only attend the measurements, but will not participate in the intervention.


Eligibility Criteria:
Inclusion Criteria:

* adults from 20 to 60 years-old
* not have a doctor-diagnosed sagittal spine disposition disorder
* not have had surgery on the spine or the hamstring musculature
* not being under a specific treatment for spinal pathology
* not involve in structured exercise programs before or during the time of the study

Exclusion Criteria:

* not being able to complete all the evaluations
* for members of the experimental group missing more than 20% of the sessions
Combined Administration of Nebulized Amikacin in Patients With Acute Exacerbation of Non-Cystic Fibrosis Bronchiectasis

This is a multi-centered, randomized, controlled study to assess the efficacy, indications and adverse reactions of combined administration of nebulized amikacin in patients with acute exacerbation of non-cystic fibrosis bronchiectasis and to evaluate whether inhaled antibiotics are more likely to cause bacterial resistance.

Objective: To assess the efficacy, indications and adverse reactions of combined administration of nebulized amikacin in patients with acute exacerbation of non-cystic fibrosis bronchiectasis and to evaluate whether inhaled antibiotics are more likely to cause bacterial resistance.

Methods: Patients with acute exacerbation of non-cystic fibrosis bronchiectasis will be randomly assigned to the observer group (participants receive nebulized amikacin BID for 14 days in combination with standard treatment) or the control group (participants receive nebulized 0.9% saline BID for 14 days in combination with standard treatment). The primary endpoint was bacterial clearance rate of sputum.

Expected results: Compared with the control group, bacterial clearance rate of sputum of the observer Group will increase significantly.

Eligibility Criteria:
Inclusion Criteria:

* Male or female study subjects ≥18 years of age and ≤80 years of age;
* Confirmed diagnosis of idiopathic bronchiectasis or postinfectious bronchiectasis;
* Confirmation of infection with Pseudomonas aeruginosa at screening;
* Are sensitive to amikacin;
* Acute exacerbation of bronchiectasis.

Exclusion Criteria:

* Bronchiectasis due to special causes;
* Smokers;
* Are associated with bronchial asthma;
* Have any serious or active medical or psychiatric illness;
* Be allergic to amikacin or not tolerant to nebulised amikacin(FEV1 reduces ≥15% after inhaling amikacin.
Transbronchial Needle Aspiration in the Diagnosis of Peripheral Pulmonary Malignancy

The main purposes of this study are to assess the performance characteristics of transbronchial needle aspiration (TBNA) in the diagnosis of peripheral pulmonary lesions, and to identify the predictor variables of a positive aspirate.

In a recent systematic literature review (Rivera PM, Mehta AC; Chest 2007; 132: 1318-1488) TBNA showed the highest sensitivity in the diagnostic bronchoscopic approach to peripheral pulmonary lesions, as compared to the other available sampling techniques (transbronchial biopsy, brushing, washings). However, the Authors conclude that the data regarding TBNA in this setting deserve cautious interpretation because of the limited number of studies and the large differences in sample size). We designed the present study to assess the performance characteristics of TBNA, alone and in comparison with those of transbronchial biopsy, in the diagnosis of peripheral pulmonary lesions.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years and older
* Pulmonary nodule (\< 3 cm) or mass (\> 3 cm) at computed tomography

Exclusion Criteria:

* Refusal to sign informed consent
* Uncontrolled coagulopathy
* Pregnancy
Effectiveness of Specialised Cognitive Behavioural Therapy (CBT) for Tinnitus.

This is an observational study of specialised CBT for tinnitus for adults delivered in routine care.


Eligibility Criteria:
Inclusion Criteria:

* Tinnitus is the primary complaint and reason for seeking help
* Participant is at least 17 years of age,

Exclusion Criteria:

* Unable to read and write in Dutch
* Tinnitus is not the primary complaint
* Person is under 17 years of age
* Participant has a health condition that prevents them from attending treatment centre
* An Ear Nose Throat (ENT) physician assesses the participant as having ontological condition that requires medical treatment
ETREAT Study on Effectiveness of Botulinum Toxin Type A Injections to Treat Post-stroke Upper and/or Lower Limb Spasticity

The objective of this study is to evaluate the effectiveness of BoNT-A on functional improvement in patients with post-stroke upper and/or lower limb spasticity in the early stage of spasticity development, according to routine clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Men and women ≥ 18-80 years.
* Poststroke limb spasticity.
* Patients who have suffered a stroke in the previous 6 months.
* Treatment goal has been previously agreed with the patient or their legal representative.
* Patients with clinically significant poststroke upper/lower limb spasticity, in whom it has been decided to perform multidisciplinary treatment with BoNT-A + rehabilitation.
* No previous treatment with BoNT-A.
* Patient is able to follow the protocol.
* Written informed consent.

Exclusion Criteria:

* Neuromuscular disease.
* Use of drugs that interfere with neuromuscular transmission.
* Any other condition that could interfere with rehabilitation or evaluation of the results.
* Diagnosis of spasticity not associated with stroke.
* Pregnant or nursing mothers.
* Prior participation in any other study in the 6 months before study entry
Outcomes of Mastoid Obliteration Canal Wall Down Tympanomastoidectomy in Cholesteatoma Surgery

Randomised study to evaluate the outcomes of mastoid cavity obliteration by muscle versus bone in canal wall down tympanomastoidectomy in cholesteatoma surgery

Regarding discharge Time of epithelizqtion Hearing outcomes Quality of life

Eligibility Criteria:
Inclusion Criteria:

* all patients who have extensive or recuutrent cholesteatoma undergoing canal wall down tympanomastoidectomy

Exclusion Criteria:

* not willing for surgery
* Malignancy

  * Patients with intracranial complication
* Residual cholesteatoma
Evaluation of Patient and Physician Reported Reasons for Switching Factor VIII Replacement Therapies

This US study will assess hemophilia A patient characteristics, health history and reasons for switching or not switching from both patient/caregiver and physician perspectives. For this purpose, this research study will include hemophilia A: 1) patients who have switched from conventional therapy to new FVIII products with an improved PK profile. 2) patients who remain on conventional therapy (who have never switched) but have considered switching, including those patients who switched from conventional therapy to new FVIII products with improved pharmacokinetics and then subsequently "switched back" to conventional replacement therapy. In doing so, real world evidence will be obtained from both patient and physician perspectives offering key insights for effective therapeutic management of patients with hemophilia A and to more fully understand what drives patient switching from a patient perspective and a physician perspective.


Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria for patients/caregivers in the Patient/Caregiver Study:

* Patients with hemophilia A (≥ 18 years of age) or caregivers of children with hemophilia A (≥12-\<18 years of age)
* Group 1: Hemophilia A patients/caregivers who have switched to FVIII products with improved half-life for the treatment of hemophilia A during the eligibility period. These patients can also include those who have switched back from FVIII products with improved half-life to conventional FVIII replacement therapy within the Data Collection Period
* Group 2: Hemophilia A patients/caregivers who are considering switching to FVIII products with improved half-life within 12 months of the Start of the Documentation period and have been prescribed prophylaxis regimen of at least 2x/week
* Able to understand, read, write and speak English
* Provide electronic informed consent
* Able to access the Internet for at least 20 minutes per day during the Data Collection Period

Inclusion criteria for physicians:

* At least 60% of time spent in direct patient care
* Board-certified or eligible with a Specialty in Hematology or Hematology-Oncology
* Physicians with a specialty in Hematology-Oncology must have at least 10% of their practice dedicated to treatment of hemophilia
* A minimum of 2 years' experience treating hemophilia A patients

Inclusion criteria for patients in the physician chart study:

* Hemophilia A patients age 12 year and over
* Prior treatment with one of the following FVIII replacement products: Adynovate, Afstyla, Eloctate, or Kovaltry
* Patients that have 12 months of medical chart data available; 6 months on conventional therapy and 6 months after switching to FVIII products with improved half-life.

Exclusion Criteria:

Exclusion criteria for patients/caregivers in the Patient/Caregiver Study:

- Hemophilia A patient initiated FVIII products with improved half-life for the treatment at time of diagnosis with hemophilia A.

Exclusion criteria for physicians:

- Unwilling to comply with the study protocol
Local Warming Technique for Arterial Cannulation in Adult Patients

Based on the fact that arterial vasodilation can be advantageous for endovascular catheterization and that an increase in body temperature can cause vasodilation by activating the cholinergic active vasodilator system, this study was planned to observe whether there was a significant change in the diameter of artery through ultrasound and to confirm the effectiveness of heating in the traditional palpation technique and the US-guided technique after local warming of the insertion site of arterial catheter in adult patients undergoing cardiac surgery.

Arterial cannulation is one of the important clinical techniques commonly used for real-time monitoring of blood pressure changes or when repeated blood tests are required. However, complications such as bleeding, hematoma, and vascular occlusion may occur if the operator has little or no experience in the procedure, or if arterial cannulation is not easy due to the patient's underlying disease and systemic factors. This situation prolongs the anesthesia induction time and may cause great harm to the patient in cases with a high bleeding tendency, such as in cardiac surgery. Various studies have reported various arterial cannulation techniques so far, and there have been many advances in arterial cannulation techniques due to the general use of ultrasound (hereafter US). However, there is still a risk of complications due to inexperience in the use of US or poor vascular status of the patient.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients over 18 years of age undergoing cardiac surgery under general anesthesia

Exclusion Criteria:

* If the patient already has an arterial catheter and does not need additional arterial cannulation.
* When arterial cannulation is performed on an artery other than the radial artery due to the surgical technique or the patient's condition.
* When the patient's condition is urgent, such as emergency surgery, and there is no time to proceed with the research.
Innovation in NOn Invasive Ventilation in COPD Patients Treated by Long Term Oxygen Therapy

The aim of this study is to investigate the efficacy of non-invasive ventilation (NIV) on nocturnal hypoventilation in patients with chronic obstructive pulmonary disease (COPD) who are on long term oxygen therapy (LTOT) at home.

This is a prospective, randomized, open labelled study. The primary outcome is nocturnal transcutaneous CO2 (PtCO2) after 3 months of non-invasive ventilation. Three hundred COPD patients on LTOT will be screened and assessed by pulmonary function tests, blood gases and nocturnal PtCO2 at their home. This will allow the determination of the prevalence of nocturnal hypoventilation in COPD patients on LTOT (a secondary outcome) and to select patients who meet the inclusion criteria for the RCT and randomization to NIV + LTOT or to continue LTOT alone (n=38). Patients will undergo the same assessments at the end of the three-month intervention period.

Eligibility Criteria:
Inclusion Criteria:

* chronic obstructive pulmonary disease (COPD)

  * on long term oxygen therapy (LTOT)
  * affiliated to French social security system or equivalent
  * informed consent signed

Exclusion Criteria:

* Diurnal PtCO2 \>55mmHg
* Patient who has had an exacerbation of COPD requiring a change in management or treatment in the last 4 weeks prior to the inclusion visit.
* Pregnant or breathfeeding women
* Prisonners or persons who require protection by the law
* Exclusion period from another study
* Persons who, according to the investigator, are expected no to meet all study obligations
Measurement of Adherence and Health-Related Quality of Life, and Health-Care Resource Utilization

The goal of this research study is to learn about the quality of life, experiences with treatment, and healthcare costs of patients who are receiving long-term treatment for venous thromboembolism (VTE) that is related to cancer.

This is an investigational study. Up to 260 participants will be enrolled in this multicenter study. Up to 170 will take part in MD Anderson.

If you agree to take part in this study, you will complete 2 questionnaires either at an already-scheduled clinic visit or over the phone at the time you join this study and then about 30 days, 3 months, 6 months, and 12 months after that. These questionnaires will be about your quality of life and experiences with treatment for VTE. It should take less than 10 minutes to complete the questionnaires each time.

Information from your medical record may also be collected at these time points.

Your participation will be over after the last questionnaires are completed at about 12 months after you enroll in the study.

Eligibility Criteria:
Inclusion Criteria:

1. Adult (≥ 18 years) female or male subjects.
2. Confirmed symptomatic proximal or distal lower extremity deep venous thrombosis with or without pulmonary embolism or other venous thromboses. For a symptomatic lower extremity deep venous thrombosis confirmed by compression ultrasonography, venography, or specific computerized tomography (CT) venography, or a thrombus detected in the iliac veins on an abdominal or pelvic CT. For symptomatic pulmonary embolism confirmed by computerized tomographic pulmonary angiography, ventilation perfusion scan, or catheter pulmonary angiography.
3. Cancer (other than basal-cell or squamous-cell carcinoma of the skin), either active or diagnosed within 2 years prior to VTE. The diagnosis of cancer must be objectively documented by histopathologic diagnosis.
4. Intention for long-term treatment (at least 3 months) with anticoagulation.
5. Participants will be enrolled in the study within the first 72 hours from initiation of anticoagulation.
6. Able to provide informed consent and complete study survey tools
7. Able to read and speak English.

Exclusion Criteria:

1. Indication for anticoagulation other than cancer-related VTE.
2. An Eastern Cooperative Oncology Group (ECOG) Performance Status of 4 at the time of study enrollment.
3. Life expectancy \< 3 months.
4. Isolated pulmonary embolism, or isolated upper extremity deep venous thrombosis, or isolated splanchnic venous thrombosis, or isolated cerebral venous thrombosis confirmed by compression ultrasonography, venography, or CT.