cyrilzakka/clinical-trials huggingface dataset:
Dietary Recommendations for Reducing Free Sugar Intakes

This randomised controlled trial aims to assess the impacts of the current recommendations by Public Health England for reducing free sugar intakes, on total energy intakes of free sugar in a sample of the UK population.

The primary objective of this randomised control trial is to assess the impacts of Public Health England's (PHE) current free sugar reducing advice, for reducing total energy intakes (TEI) of free sugar. A total of 240 participants (age 18-65years) consuming diets \>5% total energy intake from dietary free sugars will be recruited from across the Dorset region. Participants to be randomly assigned into the following recommendation interventions groups: 1) Reduce free sugar intake to \<5% TEI (nutrient-based recommendations); 2) Reduce free sugar intake to \<5% TEI, via reducing intake of specific foods identified as high in free sugars (nutrient- + food-based recommendations); 3) Reduce free sugar intake to \<5% TEI, via reducing intake of specific foods identified as high in free sugars and replace/swap with low sugar versions (nutrient- + food-based recommendations with swaps); and 4) Control Group. The primary outcome will be changes in free sugar consumption from baseline to endpoint at week 12. Secondary outcomes include change in: BMI; dietary profiles; sweetness preference; sweetness liking; food choices; low calorie sweetener intakes and adherence levels.

Eligibility Criteria:
Inclusion Criteria:

* aged 18-65 years;
* able to provide consent and complete all study materials;
* consuming \>5% of TEI from free sugars; and
* residing in the South of England.

Exclusion criteria:

* individuals who are pregnant or breastfeeding;
* underweight (BMI \<18.5);
* have pre-existing medical conditions affecting swallow ability, taste and smell perception;
* currently or within 3 months of starting the study are following a specific dietary programme (e.g.: Slimming World);
* current smokers or have smoked within 3 months of the study start date;
* have pre-existing clinical conditions such as diabetes mellitus, eating disorders, Crohn's disease and other illness's leading to participants receiving external nutritional advice and dietary restrictions.
Ertapenem Administered Subcutaneously Versus Intravenously

Infections requiring intravenous antimicrobial therapy are very common events in patients with advanced cancer. Nevertheless, these patients frequently present vascular damages becoming extremely difficult to access and maintain intravenous route for hydration and nutritional support. In this context, the subcutaneous route could be implemented as an alternative route for replacement of fluids, electrolytes and drugs. Few studies have evaluated the possibility of using the subcutaneous route for treatment of infections though.

Patients in palliative care often have infections caused by multidrug resistant bacterial such as beta-lactamase producing bacteria. In this context, we hypothesize Ertapenem subcutaneously is not inferior to the same drug intravenously for the treatment of urinary infections in patients on oncologic palliative care. A non-inferiority clinical trial would be adequate and could provide stronger evidence on the possibility of this alternative route for antibiotic therapy in urinary tract infections, with important advantages such as greater convenience of use.

This is a randomized open label clinical trial to evaluate Ertapenem administered subcutaneously is non-inferior to the same antibiotic intravenously to treat urinary tract infections in oncological palliative care patients.

The study will be performed at the Palliative Care Unit (PCU) of the National Cancer Institute of Brazil José Alencar Gomes da Silva (INCA), a 56-bed hospital and the only public hospital for cancer palliative care located in the city of Rio de Janeiro, Brazil.

A sample of 82 patients was estimated, considering the level of significance (alpha) of unilateral 2.5%, the power of the study (1-beta) of 80%, the non-inferiority limit of 4%, and success percentages in the groups control and experimental studies of 92% and 100%, respectively. Once the high mortality rate of the study site (about 60%, according to unpublished administrative information), it was decided to increase this number by 30% to compensate for possible losses, totaling 106 patients, 53 in each arm.

Eligibility Criteria:
Inclusion Criteria:

* Any type of cancer in palliative care;
* Urinary tract infection;
* Informed consent assigned by the patient or legal representative.

Exclusion Criteria:

* Neutropenia;
* Unconsciousness.
Study to Evaluate the Safety and Pharmacokinetics of Inhaled Ciprofloxacin in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Objectives of the study are to investigate the safety, tolerability and levels of ciprofloxacin in the lung after single and multiple inhalative administration to patients with moderate to severe COPD (stage II-III according to GOLD Criteria)


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with COPD, 40 to 75 years of age
* Diagnosis of COPD
* Airway obstruction with a post-bronchodilator Forced Expiratory Volume (FEV1) of \>/=30% and \</=65% of predicted and a post-bronchodilator FEV1 / Forced Vital Capacity (FVC) of \</=70%
* Current or ex-smokers with a smoking history of more than 10 pack-years
* Patients must be able to produce acceptable induced sputum samples (as defined in the Study Procedure Manual)
* Normal body weight: Body Mass Index (BMI) between 19 and 35 kg/m2

Exclusion Criteria:

* Significant respiratory disease other than COPD as bronchial asthma, Cystic fibrosis or clinically evident bronchiectasis
* More than one COPD exacerbation within 12 months and within 8 weeks prior to screening
* total blood eosinophil count \>/=600/mm3
* Thoracotomy with pulmonary resection
* Regularly use of daytime oxygen therapy for more than one hour per day and in the investigator's opinion will be unable to abstain from the use of oxygen therapy during clinic visits
* Hypersensitivity to the investigational drug or to other quinolones and/or to inactive constituents of the inhalation powder
* Hypersensitivity of the bronchial system to inhalation of nebulized drugs or saline solution
* Patients with a history of severe allergies, non-allergic drug reactions, or multiple drug allergies
* Concomitant use of medication which could interfere with the investigational drug. Before study drug administration a wash out period of more than 5 half lives has to be considered
* Concomitant inhalative therapy with antibiotics and/or concomitant systemic therapy with

  * fluoroquinolones
  * Oral beta-andrenergics, beta blockers
  * oral steroids
  * Methylxanthines: 24-hour washout of short-acting theophylline and 48-hour washout of long-acting theophylline prior to pre-study examination
  * Antihistamines, antileukotrienes prescribed for asthma
  * oral cromolyn sodium or oral nedocromil sodium
RCA for CRRT in Hyperlactatemia Patient With Increased Bleeding Risk

The purpose of this single center, randomized, control, open-labeled study is to evaluate the effect and safety of RCA versus no anticoagulation for CRRT in hyperlactatemia patients with increased bleeding risk.

For continuous renal replacement therapy (CRRT) patients with shock and muscle hypoperfusion, which characterised by tissue hypoxia and hyperlactatemia, the Kidney Disease Improving Global Outcomes (KIDIGO) guideline recommended no use of regional citrate anticoagulation (RCA) considering the potential increased citrate accumulation (CA) risk. In the condition of increased bleeding, no-anticoagulation was recommended for these patients. However, CRRT processed without anticoagulation was proved to be associated with shorter filter lifespan. Therefore, the purpose of this single center, randomized, control, open-labeled study is to evaluate the safety and efficacy of RCA versus no-anticoagulation for CRRT in hyperlactatemia patients with increased bleeding risk.

Eligibility Criteria:
Inclusion Criteria:

* Age≥16 years
* Hyperlactatemia (Lactic acid or serum lactate level \> 2 mmol/L)
* Required CRRT
* Increased bleeding risk: PLT \< 40 x 109, aPTT \> 60 s, INR \> 1.5, bleeding or active bleeding within 7 days, recent trauma or surgery (especially head trauma and neurosurgery), recent stroke, intracranial venous malformation or aneurysm, retinal hemorrhage, uncontrolled hypertension, and epidural catheter implantation.

Exclusion Criteria:

* Drugs (biguanide, linezolid, cyanide, etc.) and congenital metabolic disorders (glucose-6 phosphatase and 1,6 phosphofructosase deficiency) and mitochondrial damage caused hyperlactatemia.
* Receiving systemic anticoagulant treatment (heparin/lmol/warfarin/aspirin, etc.) within 24 hours.
* Critical patients with lactic acid ≥15mmol\\L (with a mortality of 100%) were excluded
* Patients with APTT \> 100S were excluded (retrospective data suggested that this type of patients received CRRT treatment should last for more than 24 hours)
* Patients who are pregnant or during lactation
* Severe liver failure: child-pugh score \>10 (chronic severe liver failure), MELD score \> 30 (acute severe liver failure), total bilirubin \>51 mol/L
* Patients with internal fistula were treated with CRRT
* Unable to cooperate with treatment due to mental problems (such as depression and mental illness)
* CRRT with arteriovenous fistula, or the prescribed treatment time \< 12 hours
Additive Renoprotective Effects of Oral Calcitriol in IgA Nephropathy Patients Taking Renin-Angiotensin System Blockers

This study will help to show the efficacy of vitamin D and address the optimal strategy to minimize renal injury in IgAN patients.


Eligibility Criteria:
Inclusion Criteria:

* Biopsy-proven Ig AN patients aged 20-70 years
* Patients with residual proteinuria \> 500 mg/g creatinine despite renin-angiotensin system blockade and adequate blood pressure control for more than 3 months
* Patients who give informed consent, and 4) estimated GFR \>= 30 ml/min/1.73 m2.

Exclusion Criteria:

* patients \< 20 years or \> 70 years
* hypersensitivity to vitamin D analogs
* patients who need urgent dialysis
* hypercalcemia within 3 months (uncorrected serum calcium level \> 10.2 mg/dL)
* clinical features of rapidly progressive glomerulonephritis
* life expectancy less than 24 months
* uncontrolled hypertension
* decompensated liver or lung disease
* symptomatic heart failure (NYHA class II-IV or LVEF \< 40%)
* estimated GFR \< 30 ml/min/1.73 m2.
Comparison of a Single Use (Ambu aScope) and a Reusable Flexible Optical Scope for Intubation Through a Supraglottic Airway Device (Aura-i)

In patient who are predicted to be difficult to intubate with a standard direct laryngoscope well use flexible optical intubation via a supraglottic airway devise (the Ambu Aura-i). Patients are randomly assigner to a single- or a multiple- use flexible optical scope.

We hypothesize that intubation is obtained equally effective with both types of flexible scopes


Eligibility Criteria:
Inclusion Criteria:

* ASA physical status 1-3 and evaluated pre-operatively and found suitable for tracheal intubation with a flexible optical scope via the SAD and scheduled for elective surgery/anesthesia and are conscious about their rights and consequences of participating in the study.
* The patient must have one or two of the following predictors of difficult tracheal intubation:

  1. Modified Mallampati score \> 2 (= "no parts of the Uvula is visible")
  2. a thyromental distance of less then or equal to 6.5 cms
  3. Combined movement in head and neck \< 90 degrees
  4. Mouth-opening less the 4 cm (but must be larger then 2.5 cm)
  5. Inability to protrude the teeth n the lower jaw beyond the upper incisors
  6. BMI \> 40 combined with a neck-circumference \> 43 cms
  7. Upper-lip-bite-test \> 2
  8. Previous difficult intubation or laryngoscopy (If more then two criteria are fulfilled the patient should be considered intubated awake instead. . But the upper-lip-bite-test and the prognation-beyond the incisors test represents a similar thing, namely the inability to sub-luxate the lower jaw, the if both these findings are positive it is only considered as counting for one.

Exclusion Criteria:

* ASA physical status 4 or 5
* contraindications for use of the SAD
* Patients in whom intubation via a SAD has previously failed
* Patients at risk of aspiration from the gastrointestinal channel
* diseases in mouth, pharynx or larynx that precludes the use of a SAD
* Patients in whom the cricothyroid membrane cannot be localized preanaesthetically
* Patients in whom the doctor making the pre-anaesthetic evaluation finds in need of an awake intubation
* Patients with possible Creutzfeldt-Jacobs disease or contraindication against the use of non-autoclavable equipment r risk of cross contamination with prions
Multicenter Hologic Tomosynthesis Study

The purpose of this image acquisition study is to compare, in a Reader Study, the performance of Tomosynthesis (3D) to (2D FFDM) conventional images in an enriched retrospective reader study. Synthetic 2D images, generated from the tomosynthesis image, will be available to the readers to provide an over view of the anatomy similar to a scout view in CT imaging and to determine whether the 3-D images with the synthesized 2D overview are non-inferior to the 2-D images alone as determined by receiver operating characteristic (ROC) area under the curve.


Eligibility Criteria:
Inclusion Criteria:

* Female
* Any ethnic origin
* No contraindication of routine bilateral mammography

Exclusion Criteria:

* Any contraindications to mammographic screening, including but not limited to:
* Significant existing breast trauma
* Pregnancy
* Lactating
* Previous surgical biopsy
* Previous breast cancer
* Placement of an internal breast marker
* Breast implants
* Unable to understand and execute written informed consent
* Breasts are too large to be imaged on the 24 cm by 29 cm detector with a single exposure
Computerized Anxiety Sensitivity Treatment for Opioid Use Disorders

The primary aim of the current project is to test the acceptability and feasibility of a computerized intervention, titled Computerized Anxiety Sensitivity Treatment (CAST), delivered to Veterans seeking treatment for an opioid use disorder. The second aim of the study is to examine the utility of CAST by gathering data on symptom change. The final aim of the current study is to test the effects of CAST on rates of attendance and retention in a substance use disorder treatment (SUDT) program.

The pilot project will examine the effects of a brief, one-session computerized intervention delivered to Veterans seeking treatment for an opioid use disorder. The opioid epidemic in the United States (US) is having a disproportionate impact on Veterans. Indeed, Veterans are twice as likely to die from an accidental opioid overdose than members of the general population, even after accounting for gender and age distribution. Although many individuals with an opioid addiction seek treatment, a large proportion drop out prematurely and/or relapse, highlighting the need to identify modifiable factors that may contribute to this process. One variable that may be useful in understanding attrition in addiction treatment is anxiety sensitivity (AS). AS is a well-established psychological risk factor reflecting the tendency to fear anxious arousal due to the belief that this arousal will have harmful physical, mental, and/or social consequences. AS is elevated in opioid use populations and predicts treatment dropout among opioid users. Importantly, research suggests that AS is highly malleable. Despite this, to our knowledge no published research to date has systematically explored the utility of AS reduction protocols among opioid users. The first aim of the current project is to test the acceptability and feasibility of a brief, one-session Computerized AS Treatment (CAST) delivered to Veterans seeking treatment for an opioid use disorder. Because this is a pilot project and the study will likely be underpowered to detect treatment effects, we will not emphasize symptom reduction. Nevertheless, a second aim of the current project is to examine the utility of CAST by gathering data on symptom change. Finally, a third aim of the current project is to examine the effects of CAST on rates of attendance and retention in a substance use disorder treatment (SUDT) program.

Eligibility Criteria:
Inclusion Criteria:

* Veterans must be diagnosed with an opioid use disorder

Exclusion Criteria:

* Less than 18 years of age
* Actively suicidal
* Actively psychotic
* Uncontrolled bipolar disorder (i.e., not stable on medications for at least one month)
Evaluation of a Connected Parenteral Pump for Patients Treated by Home Parenteral Nutrition (HPN).

Patients requiring long-term home parenteral nutrition (HPN) suffer from chronic intestinal insufficiency. The causes of this syndrome can be either anatomical (extensive resection of the small bowel) or functional (occlusion, pseudo-occlusion, malabsorption). Consequences mean that patients are unable to cover their oral energy and / or hydroelectrolytic needs.

As a result, these patients survive only through a nutritional support by the venous route (parenteral nutrition). However, this lifesaving therapy requires complex technological nutritional support issues at home, which will influence the personal life of the patients.

At home, HPN therapy is performed by nutrition pumps providing a constant flow and able to detect anomalies.

In this context, the development of connected systems that allow informations transmission could help patient's caregiving by the different persons involved in his follow-up (prescribing physicians, home support nurses, patients and relatives, manufacturers).

The main objective of this study is to evaluate the performance of an end-to-end data transmission chain which integrates a nutrition pump connected to a medical IoT module (developped by Maatel) able to send information to an applicative layer (software interface PatHView2, developped by Orange Labs) via different transmission modes : LoRaWAN (Long Range Wide-area network), BLE (Bluetooth Low Energy), GSM LTE-M (Global System for Mobile Communications, Long Term Evolution - Machine Type Communication).


Eligibility Criteria:
Inclusion Criteria:

* Age \< 18 years
* Patient receiving a home parenteral nutrition (HPN) and followed by the Artificial Nutrition Service of the CHUGA
* Patient carrying out all his infusions at home during the month of use of the connected pump (constraint due to the LoRaWAn transmission mode)
* Patient affiliated to the French social security system or an equivalent system
* Patient who has signed consent form

Exclusion Criteria:

* Presenting any other pathology or treatment that the physician may deem incompatible with this study
* Patient under exclusion period from another study
* Protected persons (patient concerned by articles L1121-5, L1121-6, L1121-8 of the French public health code)
Pharmacists Expand Access to Reproductive heaLthcare

Prospective cohort study of women presenting to initiate hormonal contraception, prescribed by a clinician or pharmacist. Women will be followed for one year to assess contraceptive continuation and unintended pregnancy rates, as well as measures of safety and acceptability.

Direct prescription of hormonal contraception (HC) by pharmacists, without a doctor's visit or medical prescription, is a strategy to improve access to contraception and reduce unintended pregnancy. Oregon is the first state in the nation to implement legislation, as of January 1, 2016, expanding the scope of pharmacists to prescribe short-acting HCs. House Bill (HB) 2879 allows pharmacists to directly prescribe HC including the patch and pill, without a medical prescription. Women over 18 years of age can either initiate or continue HCs with a pharmacist, and women under 18 can continue a prescription.

This prospective cohort study of women presenting to initiate hormonal contraception, prescribed by a clinician or pharmacist, aims to determine contraceptive continuation and incident pregnancy rates between women receiving hormonal contraception from a pharmacist versus other prescriber. Women will be followed for one year to assess contraceptive continuation and unintended pregnancy rates.

Eligibility Criteria:
Inclusion Criteria:

* Women presenting to initiate hormonal contraception at a study pharmacy

Exclusion Criteria:

* Pregnancy
* Contraindications to hormonal contraception
* Under 18 years of age
* Unable or unwilling to consent
Mindfulness-Based Stress Reduction for Gulf War Syndrome

This pilot study is a two arm randomized, controlled clinical trial that evaluated whether a standardized Mindfulness-Based Stress Reduction (MBSR) intervention reduces symptoms associated with Gulf War Syndrome (GWS) more effectively than treatment as usual. Fifty-five veterans meeting diagnostic criteria for Gulf War Syndrome were randomized to treatment as usual (TAU) or TAU plus an 8-week course of course of MBSR. Study measures were collected at baseline, immediate post-MBSR, and 6 months post intervention. Measures were obtained at equivalent time points for veterans randomized to TAU only. Following completion of all study activities, veterans randomized to TAU only had the opportunity to enroll in MBSR.

A randomized controlled trial with two arms. 55 veterans meeting diagnostic criteria for Gulf War Syndrome were randomized to standard care or standard care plus an 8-week course of course of Mindfulness-Based Stress Reduction (MBSR). Study measures were collected at baseline, immediate post-MBSR (within one week of completion of the MBSR class) and 6 months following completion of the MBSR course. Measures were obtained at equivalent time points for veterans randomized to usual care only. Following completion, veterans randomized to standard care only had the opportunity to enroll in MBSR.

This pilot study will whether there is sufficient evidence of benefit to warrant further study, and gathered data that will allow estimation of the sample size needed in future studies. We also obtained measures working memory and attention, in addition to patient self-report measures of symptoms, in order to provide additional assessment of whether MBSR is effective. This project is prerequisite to a larger study.

Eligibility Criteria:
Inclusion Criteria:

Chart Diagnosis of PTSD

Exclusion Criteria:

* any past or present psychiatric disorder involving a history of psychosis (schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorder not otherwise specified, etc.)
* Mania or poorly controlled bipolar
* Current suicidal or homicidal ideation
* Prior training in mindfulness meditation
* Active substance abuse or dependence
* Must not have had an inpatient admission for psychiatric reasons within the past month