cyrilzakka/clinical-trials huggingface dataset:
Acute Exposure of High Altitude on Cardiac Output

Randomized crossover trial in patients with Pulmonary Hypertension (PAH, CTEPH) to assess the acute response High Altitude (Säntis; 2500m above sea level) on non-invasive cardiac output assessments by Finapres® NOVA Technology at rest and under exercise

Low altitude baseline measurements will be performed in Zurich (460m asl) including Echocardiography, Right heart catheterization, 6MWT, pulmonary function test, clinical assessment and blood gas Analysis.

Randomly assigned to the order of testing, the participants will be tested in Low Altitude (Zurich, 470m) and at High Altitude (2500m).

During the exposure High Altitude (2500m) and Low Altitude (Zurich; 470m) up to 5 hours, the participants cardiac output non-invasively assessed will be measured repetitive during the whole intervention.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* PH diagnosed according to internation Guidelines: mPAP ≥ 25 mmHg along with a PAWP ≤15 mmHg during right heart catheterization at the time of Initial diagnosis
* PH class 1 (PAH) or 4 (CTEPH)
* Stable condition, on the same medication for \> 4 weeks
* Patient live permanently at an altitude \< 1000m asl.

Exclusion Criteria:

* Resting PaO2 ≤7.3 kPA corresponding to the requirement of long-term oxygen therapy \> 16hour daily (nocturnal oxygen therapy alone is allowed)
* Severe daytime hypercapnia (pCO2 \> 6.5 kPa)
* Susceptibility to high altitude related diseases (AMS, HAPE, etc.) based on previous experienced discomfort at altitudes.
* Exposure to an altitude \>1500m for ≥3 nights during the last 4 weeks before the study participation
* Residence \> 1000m above sea level
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, neurological or orthopedic problems with Walking disability
* Women who are pregnant or breast feeding
Oral Disintegrating Ondansetron Tablet to Reduce Vomiting From Gastroenteritis in a Pediatric Emergency Department

The objectives of the study were to determine whether ondansetron treatment would reduce:

* the amount of vomiting in the emergency department;
* the need for intravenous rehydration; and
* the need for hospitalization.

Background:

Vomiting may limit the success of oral rehydration in children with gastroenteritis and dehydration. Limited data suggest that while oral ondansetron may reduce vomiting from gastroenteritis, emergency department revisits may increase.

Methods:

The investigators conducted a prospective, double-blind randomized trial at a pediatric emergency department in 214 dehydrated children, aged 6 months to 10 years with gastroenteritis and mild to moderate dehydration as assessed by a dehydration score. They were randomly assigned to receive treatment with an ondansetron oral disintegrating tablet or placebo. Oral rehydration was administered according to a standard protocol. The primary outcome was the proportion of children who vomited during oral rehydration therapy. The secondary outcomes were the mean number of episodes of vomiting, and the proportion of children treated with intravenous rehydration or hospitalized.

Eligibility Criteria:
Inclusion Criteria:

* Acute gastroenteritis
* Non-bilious and non-bloody vomiting within 4 hours of triage
* Diarrhea
* Mild to moderate dehydration

Exclusion Criteria:

* Weight less than 8 kilograms
* Severe dehydration
* Underlying disease which might affect the assessment of hydration status (e.g., chronic renal failure, hypoalbuminemia, congestive heart failure, on diuretics)
* History of abdominal surgery
* Hypersensitivity to the drug or any components in its formulation
Nausea or Vomiting in Patients Who Are Receiving Chemotherapy for Breast Cancer or Lung Cancer

RATIONALE: Understanding how nausea or vomiting caused by chemotherapy effects a patient's treatment decisions may help doctors plan better cancer treatment and may help patients live more comfortably.

PURPOSE: This clinical trial is studying nausea or vomiting in patients who are receiving chemotherapy for breast cancer or lung cancer.

OBJECTIVES:

* Determine the contribution of nausea or vomiting to the overall importance for a current state of health in patients with breast or lung cancer undergoing chemotherapy.
* Determine the average importance for various emetic scenarios in these patients.
* Compare the importance of a specific level of chemotherapy-induced nausea or vomiting, defined by the Standard Gamble vs Morrow Assessment of Nausea and Emesis.
* Determine the feasibility of using a Standard Gamble technique in patients currently undergoing chemotherapy.

OUTLINE: This is a multicenter study. Patients are stratified according to history of chemotherapy-induced nausea or vomiting (yes vs no).

Patients undergo a structured interview over 1 hour by a trained interviewer at least 2½ weeks after initiation of the most recent course of chemotherapy and before the new course is administered. Patients complete a Functional Assessment of Cancer Therapy-General questionnaire and Morrow Assessment of Nausea and Emesis questionnaire during the interview. The trained interviewer also administers a Standard Gamble exercise during the interview, in which patients are instructed to imagine various amounts of nausea or vomiting as their current state of nausea and vomiting, and rank their importance to them. They are being asked to answer the question of whether they would choose to accept their current (imagined or real) state of nausea or vomiting or receive a medication that would result (with various probabilities) in either perfect health for 2 years or immediate death.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of breast cancer or lung cancer
* Must be undergoing chemotherapy with each course lasting 3-6 weeks AND meets all of the following criteria:

  * Completed ≥ 1 course with ≥ 1 additional course planned
  * At least 2½ weeks since initiation of the most recent course of chemotherapy

PATIENT CHARACTERISTICS:

* Common Toxicity Criteria performance status 0-2
* Must have command of written and/or spoken English

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Open-label Pharmacokinetic Study of Iron Isomaltoside 1000 (Monofer®) Administered as Single Bolus Injections in Subjects With Stage 5 Chronic Kidney Disease on Dialysis Therapy (CKD-5D)

The purpose of this study is to assess Pharmakokinetic properties of iron isomaltoside 1000 (Monofer®) in doses of 100 mg, 200 mg or 500 mg in subjects with Stage 5 Chronic Kidney Disease on Dialysis Therapy (CKD-5D).


Eligibility Criteria:
Inclusion Criteria:

1. Men and women, aged more than 18 years.
2. Weight above 50 kg.
3. Subjects diagnosed with CKD-5D and on dialysis therapy for at least 90 days prior to inclusion.
4. Serum ferritin ≤ 800 ng/mL.
5. Transferrin Saturation ≤ 35%.
6. Life expectancy beyond 12 months by Principal Investigator's judgement.
7. Hb concentrations ≥10.0 g/dL and ≤12.5 g/dL both at Screening Visit 1a and at Screening Visit 1b (Screening Visit 1a and Visit 1b must be separated by at least 1 week).
8. Erythropoiesis Stimulating Agent (ESA) treatment (to be kept constant during the study period and for 4 weeks prior to inclusion with only one missed dose to be allowed during this pre-entry period).
9. Subjects in maintenance iron therapy with average iron administration ≤ 100 mg/week for 4 weeks prior to inclusion and willingness to switch to investigational product.
10. Willingness and ability to participate after informed consent (including HIPAA, if applicable).

Exclusion Criteria:

1. Anemia caused primarily by other factors than renal related anemia.
2. Iron overload or disturbances in utilization of iron (e.g. hemochromatosis and hemosiderosis).
3. Difference of Hb ≥ 1.0 g/dL between Screening Visits 1a and 1b.
4. Known hypersensitivity to any excipients in the investigational drug products.
5. Subjects with a history of multiple allergies.
6. Decompensated liver cirrhosis and history of hepatitis B or C \[Alanine Aminotransferase (ALT) \> 3 times upper limit of normal\].
7. Acute or chronic infections (assessed by clinical investigator judgment), supported by White Blood Cells (WBC) and C-Reactive Protein (CRP).
8. Rheumatoid arthritis with symptoms or signs of active joint inflammation.
9. Pregnant or nursing women.
10. Women of child bearing potential who are not using safe contraceptive methods (e.g. intrauterine device, oral contraceptives or surgically sterilized) or who are planning to become pregnant within the study period.
11. Blood transfusion within the previous 12 weeks.
12. Planned elective surgery during the study where significant blood loss is expected.
13. Participation in any other clinical trial within 3 months prior to screening.
14. Untreated Vitamin B12 or folate deficiency.
15. Any other medical condition that, in the opinion of Principal Investigator, may cause the subject to be unsuitable for the completion of the study or place the subject at potential risk from being in the study. Examples include Uncontrolled Hypertension, Unstable Ischemic Heart Disease or Uncontrolled Diabetes Mellitus.
Observational Study of Exposure to Environmental Toxicants Among Firefighters

Observational, within subject study design with 1 pre and 2 post-fire exposure biomarker samples collected to assess exposure to toxicants from combustion emissions related to fighting a structural fire.


Eligibility Criteria:
Inclusion Criteria:

* Firefighter (career or volunteer)
* Over 18 years of age
* Able to provide written voluntary consent

Exclusion Criteria:

* Unwilling to provide a pre and post-exposure urine sample
* Current cancer diagnosis
* Tobacco use within the last 1 year (verified by urinary TNEs)
VR Integrated Into Multicomponent Interventions for Improving Sleep in ICU

Background: The patients who are admitted to ICUs mostly experience sleep disturbance. Seeking an effective strategy and integrating it into the daily routine is of clinical importance. Therefore, we aim to examine the effects of guided virtual reality integrated into the multicomponent program (SLEEP care) on sleep quality and quantity in critically ill patients. This will be a randomized controlled trial with assessor-blinded and two-arm parallel-group design. A total of 120 critical ill adults will be randomly allocated to the SLEEP care group and eyemask groups in a 1:1 ratio (60 participants in each group).

This study is expected to enroll 120 critically ill patients. We will collect basic data on the first day of admission to the intensive care unit, including demographics and disease characteristics, pain, anxiety, and stress, sleep quality and quantity, measure 5-minute HRV, wear an actigraph watch, and connect to the on-lead EEG sensor, and attach the brain wave to monitor the brain wave and sleep cycle. Then they will be randomly assigned 1:1, dividing into SLEEP care group and eyemask group. Participants who are in the control will receive eyemask intervention and daily care in the ICU. Participants who are assigned to the SLEEP care group will receive the VR and night sleep promotion routine. The researcher will assist participants to wear a virtual reality helmet for a 30-minute program at 10 pm, and then remove the helmet and wear eye masks until 6:30 in the morning. The ICU routine care of promoting sleep is still maintained. The next morning (the second day of the ICU), the researcher will assist participants to remove EEG sensors and evaluate the RCSQ scale to understand the previous night's sleep. The above process will repeat for three days (ICU days 1 to 3) until the intervention and measurement during the intensive care unit are completed on the morning of the fourth day. In order to understand the impact of sleep on cognitive function during the stay in the intensive care units and after discharge, the PSQI, VAS of pain, anxiety, and stress (confounders), and MOCA will be evaluated in the first and sixth months after discharge.

Eligibility Criteria:
Inclusion Criteria:

* Aged 20 years and above.
* Conscious and able to communicate with Chinese or Mandarin.
* To stay in ICU at least 72 hrs

Exclusion Criteria:

* The medical history of sleep disorder, cognition impairment, psychiatric disorders, seizures, visual difficulty or hearing difficulty
* The APACHE II score over than 25
* The participates who are delirium
Dynamics of AMR Spread, Persistence and Evolution Between Humans, Animals and Their Environment

Humans in contact with animals such as dog owners, may be at risk of antimicrobial resistance (AMR) acquisition. This is the central issue to be investigated in DYASPEO

Antimicrobial resistance (AMR) is a global and multifaceted public health problem. Advanced knowledge on AMR has demonstrated that it not only affects humans but is also widely distributed across animals and the environment. A major cause of the AMR burden refers to the capability of AMR to transmit within and between individuals, including between humans and animals. Leading examples of internationally distributed AMR bacteria are Enterobacterial disseminating resistances to extended-spectrum cephalosporins (ESC-E) and carbapenems (CP-E). Yet, the magnitude and pathways of their cross-sectorial transfers are poorly understood.

There is a great concern that humans in contact with animals be at risk of ESC-E/CP-E acquisition. Whereas an increase in ESC-E carriage in farmers in contact with their food-producing animals was reported, AMR transmission to humans through direct contacts with companion animals has been much less studied. Owing the close relationships between pets and owners, and the fact that 50% of households host a dog or a cat in France, the hypothesis of pet ownership being a risk for humans to acquire ESC-E/CP-E appears strongly relevant. The DYASPEO project will investigate this question through a combination of several approaches from field to laboratory studies, and including epidemiology, ecology, molecular and population genomics, studies on intestinal microbiota, modelling and social sciences.

We hypothesize that the interface between humans and companion animals plays a significant role in the transfer of ESC-E/CP-E. This hypothesis is corroborated (i) by recent data in France showing that antibiotic exposure of companion animals is still increasing contrary to all other animal host (e.g. food-producing animals) and (ii) by a recent study from the consortium demonstrating a high AMR prevalence in dogs getting back home after hospitalization.

Eligibility Criteria:
Inclusion Criteria:

* Adult or child planning to live in the same household as his/her dog during the three months following inclusion.
* Planning to live in the same habitat in the next three months following inclusion (except for holidays).
* Written consent of all adults and of at least one of the two parents for minors under parental authority. A different information note will be elaborated for each age category (6-10 yr-old, 10-15 yr-old and 16-18 yr-old).
* Owning a dog recorded for a surgery at the National Veterinary School

Exclusion Criteria:

* Lack of signed informed consent
* Subject in alternating custody
* Subject under legal protection (guardianship)
* Subject deprived of liberty under judicial constraint
* Subject undergoing psychiatric care
* Lack of affiliation to a social security scheme
* Volunteers who do not speak/write French
Serum Phosphatemia Predictive Marker for AKI Diagnosis After Cardiac Surgery

Cardiac surgery associated acute kidney injury is an independent factor of morbidity and mortality . Despite its delayed elevation, serum creatinine (Cr) remains the goal standard to diagnose AKI. Hyperphosphatemia is well-know in case of AKI because of its excretion decrease. Moreover, serum phosphorus (Ph) is daily measure d after cardiac surgery since its variation may lead to cardiac dysfunction. In case of AKI, Ph may reflect the decrease of renal function in this context. Consequently, the purpose of this study is to evaluate the predictibility of Ph to detect both AKI induction and in a second time, renal recovery.

It is a one-year prospective diagnostic validation study included all patients \> 18 years-odl admitted in our center after cardiac surgery. AKI is define according to KDIGO criteria and classified in the groups of severity according to the Cr elevation and the need of renal replacement therapy. Serum Cr and Ph are measured at baseline before surgery , at ICU admission, every 12 hours until ICU discharge and every 24 hours until hospital discharge. To evaluate the predictability of Of Ph to diagnose AKI, the postoperative Ph percentage of maximal elevation (%EPh) will be calculated. Then the diagnostic performance of %EPh wil be assessed by calculating the areas under the Receiver Operating Characteristic Curve (AUC) to determine an optimal threshold with sensibility, specificity, positive predictive value and negative predictive value.

Eligibility Criteria:
Inclusion Criteria:

* All the patients who are more than 18 years having cardiac surgery and having benefited from a dosage of serum phosphorus level and serum creatinine during all the duration of the hospitalisation

Exclusion Criteria:

* Chronic renal insufficiency with a glomerular filtration rate = 15ml / min / 1.73m2
* Chronic Renal insufficiency dialysed
* History of single kidney or nephrectomy
* Vulnerable people according to the article L1121-6 of the public health Code
* Protected adult or in the incapacity to give his consent according to the article L1121-8 of the public health Code
* The patient present formalizes his opposition for the continuation of the study
* Pregnant or breast-feeding Women according to the article L1121-5 of the Public health Code
Pharmacokinetics and Pharmacodynamics Study of Saxagliptin in Healthy Subjects

To characterize the steady-state pharmacokinetics (PK) of 2.5 mg saxagliptin administered twice daily with meals to healthy subjects


Eligibility Criteria:
Inclusion Criteria:

* Men and women ages 18 to 45 inclusive
* Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
* Body Mass Index (BMI) of 18 to 32 kg/m², inclusive. BMI = weight (kg)/ \[height (m)\]²

Exclusion Criteria:

* WOCBP who are unwilling or unable to use acceptable barrier methods (condoms and spermicides) to avoid pregnancy for the entire study period and for up to 8 weeks after the last dose of investigational product
* Any significant acute or chronic medical illness
* Current or recent (within 3 months) gastrointestinal disease
* Any major surgery within 4 weeks of study drug administration
* History of allergy to DPP4 inhibitor or related compounds
* Prior exposure to saxagliptin
Closed Suction Drainage After Revision Hip Arthroplasty

Prospective, randomized trial. 40 patients who underwent revision hip arthroplasty, divided in to two groups with or without drainage. All patients was assessed with ultrasonography on 3rd day after surgery. Bleeding, need for blood transfusion and laboratory test was analyzed after surgery. Patients was assessed with Harris Hips Score and Visual Analog Scale after surgery.

Inclusion criteria: aseptic loosening, head or insert damage, girdlestone hip. Exclusion criteria: septic loosening, primary or secondary coagulopathy, renal or hepatic failure, thromboembolism in past history. At the end of operation information of drainage was get out from the envelope. On 3rd day all patient get ultrasonography with level of fluid in the joint and hematoma in soft tissue measurement. We analyzed hemoglobin, C-reactive protein, erythrocyte sedimentation rate on 1st and 3rd day after surgery. Visual analog scale was taken on 3rd day after surgery and Harris Hip Score 6 weeks after.

Eligibility Criteria:
Inclusion Criteria:

* aseptic loosening,
* head or insert damage,
* girdlestone hip

Exclusion Criteria:

* septic loosening,
* primary or secondary coagulopathy,
* renal or hepatic failure,
* thromboembolism in past history
Comparison of DCT, ORA and GAT in Eyes After Penetrating Keratoplasty

To compare intraocular pressure (IOP) measured by the Reichert Ocular Response Analyzer (ORA), Pascal dynamic contour tonometer (DCT) and Goldmann applanation tonometer (GAT) in eyes after Penetrating Keratoplasty (KPL)

A few tonometers are used today in clinical practice for measuring intra ocular pressure (IOP). Each tonometer is based on different technology.

Post penetrating keratoplasty (PK) eyes are at risk for developing secondary glaucoma (9-14%). Elevation of the IOP may cause rejection of the graft or alternately a loss in the endothelial cell layer count causing decompensation of the cornea. Therefore, measuring accurately the IOP in this population is of great importance.

Measuring IOP in post PK is not an easy challenge, mainly because of parameters like the central corneal thickness (CCT), the curvature of the cornea, the axial length and biomechanical properties which diverse from normal eyes.

The Goldmann applanation tonometer (GAT) is the gold standard tonometer for measuring IOP and is the most popular tonometer clinically used. IOP measurements via the GAT are based on the assumption that the CCT is constant. post PK eyes CCT might diverse from normal eyes causing GAT IOP measurements to be inaccurate. The Pascal dynamic contour tonometer (DCT) measures IOP independently of corneal parameters. The Ocular response analyzer (ORA) is based on a non contact technique of measurement. The tonometer is thought to be independent of factors such as CCT.

The aim of the study is to compare intraocular pressure (IOP) measured by the Reichert Ocular Response Analyzer (ORA), Pascal dynamic contour tonometer (DCT) and Goldmann applanation tonometer (GAT) in eyes after Penetrating Keratoplasty (KPL). In addition its aim is to discover the dependence of different parameters, like - CCT, curvature of the cornea, axial length and biomechanical properties on IOP measurement to elucidate the appropriate tonometer for this population.

Eligibility Criteria:
Inclusion Criteria:

* Eyes after KPL surgery at the Goldschleger Eye Institute in the last 10 years.

Exclusion Criteria:

* Uncooperative subjects for whom good quality results are unattainable.