cyrilzakka/clinical-trials huggingface dataset:
6 Minute Walk Test in Cystic Fibrosis

The purpose of this study is to determine whether the 6-minute walk test (6MWT) could be a prognostic factor for cystic fibrosis patients.

The 6-minute walk test is a simple exercise test, reproducing a daily physical activity. The utility of this test is described in several chronic lung diseases (chronic obstructive pulmonary disease, idiopathic pulmonary arterial hypertension). The distance performed during the 6MWT and / or desaturation during the 6MWT is a prognostic factor that contributes to the assessment of patients for lung transplantation indication.

The 6MWT is practiced routinely in cystic fibrosis centers but its usefulness in this disease has not been shown. Also the results of this test are not part of the decision-making criteria for lung transplantation.

A single-center study performed in adults CRCM at Cochin Hospital suggests the prognostic value of the 6MWT in patients with adult's cystic fibrosis.

The principal objective of this study is to assess the prognostic of 6MWT as part of the cystic fibrosis. The primary endpoint will be to assess the survival without lung transplant during the follow up period of 3 years. In this context, this prognostic tool could be used to help to determine the best time to consider a lung transplant in cystic fibrosis patient.

Eligibility Criteria:
Inclusion Criteria:

* Patient with Cystic Fibrosis (bronchiectasis with presence of two mutations in the CFTR gene and / or positive sweat test.
* Patients aged 18 year or older.
* Pre-bronchodilator FEV1 FEV1 ≤ 60% from theoretical value: this FEV1 limits is proposed following the results from our published study (Martin et al. 2013) showing that desaturation during 6MWT and a distance ≤ 475m performed, are almost exclusively found in patients with FEV1 ≤ 60% .
* Stable health status ( \>15 days after the start of treatment of a respiratory exacerbation
* No indications against the walking test:

Left uncontrolled heart failure Severe aortic stenosis acute endocarditis syncope Symptomatic severe arrhythmia stable angina Myocardial infarction \<5 days Acute respiratory distress Resting SpO2≤85% pulmonary edema Uncontrolled asthma Arterial or venous thrombosis of the lower limbs, Severe acute condition that may interfere with the exercise performance (infections, renal failure, hyperthyroidism, unable to cooperate, severe pulmonary arterial hypertension, severe systemic blood pressure (Systolic blood pressure \>200 mm Hg and / or diastolic blood pressure \>120 mm Hg))

Exclusion Criteria:

* History of lung transplant
* Oxygen Dependence (inability to achieve a 6-minute walk test in ambient air)
* Any indication against walk test
* Pregnant women, persons deprived of liberty, person under guardianship, person in emergency situation
* Person not affiliated to social security system
* Refusal to participate in the study
Bloodsafe Ghana- Iron and Nutritional Counseling Strategy Pilot Study

This pilot study has 2 components: 1) a cross-sectional assessment designed to estimate the prevalence of anaemia leading to donor deferral, the prevalence of iron deficiency (ID) and iron deficiency anaemia (IDA) among first-time donors, and 2) a longitudinal 2-arm parallel groups trial among first- time voluntary donors that compares haemoglobin levels at 4 months among those with ID or IDA who receive iron supplementation to those without ID or IDA who do not receive iron supplementation. A structured questionnaire will be used to extract demographic characteristics. Participants will be followed for a total of 6 months with study visits at 2, 4 and 6 months after the baseline assessments. Blood draws for full blood count (FBC), peripheral film comment, malaria rapid diagnostic tests (RDT) and ferritin assessment will occur at baseline and all follow-up visits. In addition, we will use a qualitative approach to identify barriers and facilitators of blood donation and the use of dietary and iron supplementation strategies to address iron deficiency and/or anaemia. This will involve conducting focus group discussions during the last month of the intervention and key informant interviews.

Expected Outcomes The expected outcomes of the study have been grouped into two, primary and secondary. Primary Outcome will be haemoglobin level after 4 months. Secondary Outcomes are A. Change in haemoglobin levels B. Diagnosis of ID or IDA at 4 months C. Serum ferritin concentration after 4 months of intervention D. Acceptability of iron supplementation among participants and stakeholders E. Incidence of gastrointestinal adverse events F. Incidence of suspected malaria or bacterial infections G. Incidence of ID and IDA H. Successful return (non-deferred) to the blood donor pool after intervention within 6 months of enrolment I. Key barriers and facilitators of intervention implementation.


Eligibility Criteria:
Inclusion Criteria:

* Males or females aged between 17 and 60 years who weigh at least 50kg.
* Pass pre-donation screening using the NBSG standardised donor screening questionnaire for medical conditions and lifestyle risks for transfusion transmissible infections
* Vital signs must meet the NBSG requirement for blood donation: systolic and diastolic blood pressures between 90-140 mmHg and 60- 90 mmHg, respectively; pulse rate between 50-100 bpm; non-contact forehead temperature not exceeding 37.5°C; meeting acceptable requirements for skin lesions, needle marks and physical appearance.
* Must be willing and able to give study consent or assent.
* Intend to remain in the study location/site during the entire length of the study.

Exclusion Criteria:

* Persons who have used iron supplementation within the past one month.
* Participant reports having previously donated blood.
* Evidence for a TTI at baseline among those who successfully donated.
* Evidence of Malaria and helminthic infections at baseline
* Participants who have Hb \<10g/dl at screening
Global Coagulation Assessment in Cirrhosis and ACLF

Background: Patients with cirrhosis and acute-on-chronic liver failure (ACLF) may have bleeding complications which can lead to increased mortality. Standard coagulation tests (SCTs) like prothrombin time, platelet count and activated partial thromboplastin do not accurately depict in vivo coagulation profile. Point-of-care viscoelastic coagulation testing devices like thrombo-elastography (TEG) and Sonoclot may be better for guiding patient management.

Methods: This prospective observational study compared and validated the point of care (POC) tests and SCTs in 70, 72 and 25 persons with ACLF, decompensated cirrhosis and healthy controls respectively.


Eligibility Criteria:
Inclusion Criteria:

* All patients with Acute on Chronic Liver Failure
* All patients with cirrhosis of Liver

Exclusion Criteria:

* Recent blood or blood component transfusion in last 2 weeks
* HIV infection
* Antiplatelet, anticoagulant or antifibrinolytic therapy
* Patients on Dialysis
* Pregnant females
* Active malignancy in last 5 years
* Chronic heart failure
* Chronic pulmonary disease
* End stage renal disease
Heparin and the Reduction of Thrombosis (HART) Trial

Heparin is frequently used in central venous catheters (CVCs) in post-operative cardiac patients. It remains unclear if a heparin infusion, compared to a normal saline infusion, prevents thrombosis of CVCs after surgery. This study will answer the question: does a low-dose heparin infusion (10 units/kg/h) prevent thrombosis, compared to a normal saline infusion, in patients less than one year of age after cardiac surgery?

Patients are contacted pre-operatively and their parents consented. The following criteria apply:

Inclusion criteria:

All infants \< 1 year of age undergoing cardiac surgery at Lucile Packard Children's Hospital

Exclusion Criteria:

Known coagulopathy History of clinically significant bleeding (GI, cranial, pulmonary) Need for therapeutic heparinization ECMO

Randomization and blinding are performed in the Pharmacy. The intervention is initiated at the intensive care unit physician's discretion, generally within the 1st 24 hours post-operatively. The study is terminated when all catheters have been discontinued or at POD #14, whichever occurs first.

Thrombosis is demonstrated by echocardiogram or ultrasound performed at

1 - 3 days, 5 - 7 days, and 10 - 14 days after initiation of the study drug.

The following are calculations for statistical analysis:

Sample size determination - Using 2 - sided alpha = 0.05 and Beta = 0.2, and assuming a baseline thrombosis incidence of 20%, 160 patients are required to detect an effect size of 15%.

Eligibility Criteria:
Inclusion Criteria:

* All infants \< 1 year of age undergoing cardiac surgery at Lucile Packard Children's Hospital \& #xA

Exclusion Criteria:

* Known coagulopathy
* History of clinically significant bleeding (GI, cranial, pulmonary)
* Need for therapeutic heparinization
* ECMO
Quality of the Management of Diabetes in Elderly People With Dementia in France

Along with population ageing, the association of chronic conditions such as Alzheimer's Disease and Related Syndromes (ADRS) and diabetes mellitus is increasing in clinical practice. According to ADRS severity, guidelines of diabetes care may be adapted for a personalized monitoring and treatment. The consequences on diabetes complications are not known and can also threaten dementia progression. Based on a nationwide healthcare reimbursement database, the present study aimed to compare diabetes care and the incidence of acute complications between patients with or without ADRS, in a longitudinal perspective focusing on the pivotal period of ADRS identification by the healthcare system.


Eligibility Criteria:
Inclusion Criteria:

* individuals with a first ADRS criterion in 2011 or 2012,
* prevalent diabetes mellitus, defined by a LTD with ICD-10 codes of diabetes mellitus ("E10-E14").
* at least one reimbursement in the year preceding inclusion.
Effects of a Home Based Walking Program Using Rhythmic Auditory Stimulation in Patients With Multiple Sclerosis

Rhythmic Auditory Stimulation (RAS) is a music therapy technique that provides rhythmic auditory cues (like a beat) to help improve patients' movements, especially when walking.

The purpose of this study is to compare the effect on walking performance of a home based walking program (HBWP) with Rhythmic Auditory Stimulation (RAS), to that of a HBWP without RAS, or to RAS without walking exercise.

A second part of this study will assess the effects of Rhythmic Auditory Stimulation (RAS) on brain activity in patients with Multiple Sclerosis while performing mental imagery of walking.


Eligibility Criteria:
Inclusion Criteria:

1. age 18 years or older
2. diagnosis of MS per Mc Donald criteria
3. Ambulation Index score from 2 to 6 inclusive (clinically observable gait disturbance, whether the subject walks with no, unilateral, or bilateral support)
4. spastic paresis is the main neurologic impairment causing the gait disturbance, per investigator's judgment.

Exclusion Criteria:

1. neurologic impairments other than spastic paresis (e.g. cerebellar ataxia or sensory ataxia), or non-neurologic impairments (e.g. musculoskeletal problems) play a major role in the subject's gait disturbance, per investigator's judgment;
2. treatment for an MS exacerbation in the past 30 days;
3. severe co morbidity precluding participation in the study per investigator's judgment (e.g. severe cardiac or respiratory failure);
4. severe cognitive deficits precluding informed consent or preventing the subject from following study procedures safely
5. contraindication to MRI such as severe claustrophobia and implanted devices such as neurostimulators, pacemakers, aneurysm clips etc.
6. pregnancy.
An Interaction Study to Evaluate the Effect of Esomeprazole/Acetylsalicylic Acid on the Metabolism and Effect of Clopidogrel

The primary purpose of this study is to assess whether esomeprazole 20 mg/Acetyl Salicylic Acid (ASA) 81 mg affect the metabolism of clopidogrel.


Eligibility Criteria:
Inclusion Criteria:

* Male (aged between 18 and 45 years inclusive) or female (aged between 18 and 55 years inclusive) healthy volunteers
* Female healthy volunteers must be of non-childbearing potential or be of childbearing potential, be non-lactating and have a negative pregnancy test during the pre-entry visit and be using 1 clinically accepted method of contraception
* Have a body mass index between 19 and 30 kg/m2 inclusive
* No clinically significant abnormal findings at the physical examination as judged by the investigator

Exclusion Criteria:

* Any clinically significant abnormalities in laboratory screening results as judged by investigator
* Platelet count \<150 x 10\^9/L on Day -1 or any other conditions that would increase the risk of bleeding
* Previous bone marrow transplant
* Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG
Study on Theraputic Drug Monitoring and Phamacokinetics of Isavuconazole in Children

The goal of this clinical trial is to learn the plasma concentration of isavuconazole in pediatric patients. It will also learn about the relationship of isavuconazole plasma concentrations to efficacy and safety in pediatric patients. The main questions it aims to answer are:

What is the plasma concentration after using isavuconazole in pediatric patients? What is the effective range of plasma concentration of isavuconazole in pediatric patients? What is the safe range of plasma concentration of isavuconazole in pediatric patients? Researchers will measure the plasma concentration of isavuconazole to see whether it is appropriate.

Participants will:

Take drug isavuconazole as prescribed by the doctor;

1mL of blood is drawn 30min before the next dose.

Objectives of Study:

Main objective: To monitor the plasma concentration of isavuconazole in children, and to study the pharmacokinetic characteristics of isavuconazole in children, so as to provide basis for the optimization of individualized drug administration.

Secondary objective: To evaluate the relevance of isavuconazole plasma concentrations to efficacy and safety in pediatric patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients who intend to take isavuconazole for the treatment of invasive mycosis;
* Aged 0-18 years, gender unlimited;
* The subject and his/her guardian are willing to comply with the procedures and operations specified in the study protocol;
* The guardian of the subject and the subject of independent informed age are willing and able to provide written informed consent to participate in the study.

Exclusion Criteria:

* The subject is known to be allergic to any azole antifungal therapy or other ingredients contained in the study drug;
* The researcher believes that the condition of the child may interfere with study participation or other inappropriate conditions.
MAPD: Modifiable Factors Affecting Propofol Dosing

The investigators aim to understand the effect of a caffeine intake, sleep habits, anxiety about surgery, alcohol intake and smoking status upon the dose of the anaesthetic drug, propofol, required for anaesthetic induction.

The investigators hypothesise that modifiable environmental factors may cause reversible changes in a patients neurobiology which affect their responsiveness to anaesthetic drugs. Such factors may include chronic caffeine intake, chronic sleep deprivation, acute anxiety about surgery, alcohol intake and smoking. Investigation of the relationship between such factors and the dose of anaesthetic required for loss of consciousness may not only allow for better prediction of dose requirements but may also allow for optimisation of patients prior to undergoing general anaesthesia with a view to decreasing anaesthetic dose requirements and the complications associated with this.

To address this questions, the investigators will be asking patients admitted for any day case surgery at Chelsea \& Westminster hospital to complete five short questionnaires and a demographic sheet addressing 1) Caffeine intake 2) Sleep habits 3) Anxiety about the operation 4) Alcohol intake 5) Smoking status.

This will then be compared to the amount of the anaesthetic drug Propofol required and the time taken to induce loss of consciousness prior to surgery. Loss of consciousness will be measured subjectively by loss of eye opening response and loss of verbal response when a patient is asked to count upwards from 1.

The investigators also wish to investigate whether these same 5 factors affect patient reported postoperative pain and analgesia requirements. As such the investigators will also ask participants to rate their level of pain whilst at rest and whilst coughing at 1 hour after the operation. We will also record how much analgesia is requested and received in the postoperative period.

Eligibility Criteria:
Inclusion Criteria:

ASA I or II patients scheduled for elective day case general anaesthesia with Laryngeal Mask Airway (LMA) airway insertion and a standard propofol-fentanyl induction, aged between 18-65 years at Chelsea \& Westminster Hospital.

Exclusion Criteria

1. Pregnancy
2. Neurological disease
3. Substance abuse
4. Cardiac disease
5. Renal disease
6. Obesity

Additional exclusion criteria include:

1. Any patient requiring adjunctive analgesia including local/epidural/spinal anaesthesia.
2. Any patient requiring an anesthetic induction regime other than propofol-fentanyl (inc. administration of benzodiazepines or other strong opioids).
3. Any patient who does not receive a standard anaesthetic induction regime due to clinical need
Peri Operative Smoking Cessation Program

Implementation of a perioperative smoking cessation program with computer based patient education increases the rate of short term (1 month) and long term (6 month) reduces the incidence of perioperative complications in elective surgical patients.

Patients will be enrolled in the quit smoking before surgery program. Before participating in the education program, the investigators will ask patients questions about their smoking habits, and patient will complete pre-education questionnaires that should take about 5 minutes. Patients will participate in a computer-based education program about quitting smoking for about 15 minutes. It will explain the importance of quitting smoking before their surgery, how to quit and coping with quitting. If they are not familiar with using a computer, we will provide an assistant for them to complete the education program. After completing the education program, they will complete a post-education questionnaire. patients will also receive an information pamphlet.

All participants will receive the computer-based education program, brief counselling, pamphlet, Smokers' Helpline referral, and telephone follow-up.

Altogether you will be spending about 30 minutes to complete the assessment, education program and counselling.

patients will be asked for their permission to inform their family physician about their participation in this study. Their smoking status, date of surgery, quit date, and recommended medication (when appropriate) will be faxed to your family physician to assist them quitting process. If they are willing to accept the assistance from Smokers' Helpline, their name and phone number will be faxed to the Smokers' Helpline, and someone from Smokers' Helpline will call you in the next 48 hours to follow-up.

The investigators will monitor patient's smoking behavior by measuring expired carbon monoxide, a gas in the air they breathe out, during their pre-surgery visit and on the day of surgery. We also will measure urine cotinine (a by-product of nicotine) by taking urine samples and check their smoking status by asking questions about their smoking habits on the day of surgery, 1 month, 3 months and 6 months after their surgery. During the telephone interview follow-up, we will remind them to do the urine cotinine and mail it to us. (Prepaid mail with urine cotinine strip will be provided at the time of the 2nd visit on the day of surgery.) Each follow-up phone call will take about 6 -10 minutes.

A one-month,3 month and 6 month follow up will be done by the research coordinator to assess the smoking status. Brief counseling (\< 5 mins) will be provided.

Eligibility Criteria:
Inclusion Criteria:

* Patients\> 18 years of age
* self reported smokers ( daily or non daily smokers)
* Scheduled for elective surgical procedures

Exclusion Criteria:

* patients who cannot read and understand English
* Have any form of cognitive impairment
* Do not have a telephone
* Drug or alcohol abuser dependence within the past year
* Patients whop are already on pharmacotherapy for smoking cessation.
High-Risk HPV Infections in Women Aged 25 to 65

The purpose of this study is to determine risk factors for HPV infections in 25 to 65 year old women who report having used internet dating websites in the past year.

Whether older women are susceptible to acquiring new, persistent high-risk (HR) HPV infections from new sex partners is largely unknown. This is a pilot study of predictors of HR HPV infections in two populations of women aged 25 to 44 and 45 to 65 who have used internet dating websites in the past year. 400 women will be recruited and mailed kits for self-collecting vaginal specimens for HPV DNA testing. Women will self-collect two sets of vaginal specimens four months apart, and complete sexual behavior questionnaires at the time of each self-collection. If new HPV infections associated with recent new partners are detected in these women, this pilot data will be used to develop a larger longitudinal study of the acquisition and natural history of HR HPV infections in older women. This information is important for developing guidelines for HPV vaccine implementation and cervical cancer screening guidelines in populations of older women.

Eligibility Criteria:
Inclusion Criteria:

* Have had sex with men
* Have used the internet to search for romantic partners in the past year (e.g. posted or responded to an ad on an internet dating website or social networking website)

Exclusion Criteria:

* Pregnant, breastfeeding, or planning a pregnancy in the next 6 months
* Hysterectomy
A Dose-finding and Feasibility Study for a Prolonged 13C-octanoate Breath Test for Gastric Emptying

The objective of this dose-finding and feasibility study is to establish the optimal 13C-octanoate concentration to be used with slowly infused enteral nutrition to perform a prolonged gastric emptying test using the breath test. More specifically, the aim is to discover the 13C-octanoate concentration that induces a steady state hourly 13C-recovery. This would allow to implement the prolonged breath test protocol in a future clinical investigation in critically ill patients.


Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent
* At least 18 years old
* BMI between and including 18 and 29
* Understand and able to read Dutch
* In good health on the basis of medical history
* Refrains from herbal, vitamin and other dietary supplements on the day of the visits

Exclusion Criteria:

* Dyspeptic symptoms (assessed with PAGI-SYM questionnaire, Annex II)
* Using any medication that might affect gastric function or visceral sensitivity
* Known / suspected current use of illicit drugs
* Known psychiatric or neurological illness
* Any gastrointestinal surgery that could influence normal gastric function in the opinion of the investigator
* History of heart or vascular diseases like irregular heartbeats, angina or heart attack
* Nasopharyngeal surgery in the last 30 days
* Suspected basal skull fracture or severe maxillofacial trauma
* History of thermal or chemical injury to upper respiratory tract or esophagus
* Current esophageal or nasopharyngeal obstruction
* Known coagulopathy
* Known esophageal varices
* Have a known allergy or intolerance to cow milk, soy or any other ingredient of Isosource Standard.
* Known galactosaemia