cyrilzakka/clinical-trials huggingface dataset:
Standard Issue Transfusion Versus Fresher Red Blood Cell Use in Intensive Care- A Randomised Controlled Trial

In Australia, blood for transfusion has a "use by" date of 42 days after collection. The actual age of blood given to patients depends on what is available at the time and the rate of usage. During the last decade, it has been reported that blood transfusion in patients admitted to intensive care was associated with an independent increase of mortality. Some research suggests that transfusion of fresher blood might help patients in the intensive care unit to reach a better recovery. This project will test whether patients who receive 'fresher' blood do better than patients who receive 'standard issue' blood.

Inclusion criteria

•Patients hospitalised in ICU with an anticipated ICU stay of at least 24 hours, in whom the decision has been made by medical staff to transfuse at least one RBC unit.

Exclusion criteria

* Age younger than 18
* Previous RBC transfusion during the current hospital admission (including transfusion in another hospital for transferred patients)
* Diagnosis of transplantation or hematologic diseases
* Pregnancy
* Cardiac surgery during the present hospital admission
* Expected to die imminently (\<24hrs)
* The treating physician believes it is not in the best interest of the patient to be randomised in this trial.
* Known objection to the administration of human blood products
* Participation in a competing study

Primary outcome- 90 day mortality

Secondary outcomes

1. 28 day mortality
2. Persistent Organ Dysfunction combined with death at 28
3. Days alive and free of mechanical ventilation at day 90 post randomisation
4. Day alive and free of renal replacement therapy at day 90 post randomisation
5. Blood stream infection in ICU (post randomisation) defined using the Center for Disease Control and Prevention/National Healthcare Safety Network criteria
6. Length of stay in ICU and in hospital post randomisation
7. Febrile non-haemolytic transfusion reactions
8. EQ-5D score at Day 90 post randomisation

Eligibility Criteria:
Inclusion Criteria:

* Patients hospitalised in ICU with an anticipated ICU stay of at least 24 hours, in whom the decision has been made by medical staff to transfuse at least one RBC unit.

Exclusion Criteria:

* Age younger than 18
* Previous RBC transfusion during the current hospital admission (including transfusion in another hospital for transferred patients)
* Diagnosis of transplantation or hematologic diseases
* Pregnancy
* Cardiac surgery during the present hospital admission
* Expected to die imminently (\<24hrs)
* The treating physician believes it is not in the best interest of the patient to be randomised in this trial.
* Known objection to the administration of human blood products
* Participation in a competing study (see below)
Physical Activity Level and Sleep Quality in Type 2 Diabetes

In this study, we investigated the effects of physical activity level and sleep quality level on total antioxidant level (TAS), total oxidant level (TOS), Malondialdehyde (MDA) and Superoxide Dismutase (SOD) which are markers of oxidative stress, irisin, fibronectin type III-protein 5 (FNDC5).


Eligibility Criteria:
Inclusion Criteria:

* Being between 30-65 years old
* Volunteering to participate in the study
* Being literate
* Being diagnosed with Type 2 Diabetes

Exclusion Criteria:

* Having a physical or mental illness that prevents communication
* malignant disease,
* infectious disease,
* chronic obstructive pulmonary disease,
* liver disease,
* patients with kidney disease and joint or muscle disease will not be included
Inorganic Nitrate and OSA

The main purpose of this study is to determine if acute beetroot juice supplementation reduces peripheral chemoreflex sensitivity in patients with obstructive sleep apnea. All subjects will consume low-dose (BRL), higher-dose (BRH), and placebo (BRP) beetroot juice randomly on three independent study visits. Beetroot juice also improves blood flow thus, the investigators will also measure blood flow to the carotid chemoreceptors.

Four-weeks of daily beetroot juice supplementation reduces peripheral chemoreflex sensitivity in healthy older adults who have 'normal' responses to acute hypoxia. Patients with obstructive sleep apnea have exaggerated peripheral chemoreflex sensitivity. It remains unknown if beetroot juice supplementation reduces peripheral chemoreflex sensitivity in patients with obstructive sleep apnea. Additionally, increasing blood flow to the peripheral chemoreceptors reduces sensitivity. Given that beetroot juice improves blood flow, the investigators will also measure common carotid artery blood flow at rest and during hypoxia.

Eligibility Criteria:
Inclusion Criteria:

* OSA group: patients recently diagnosed with mild-to-moderate OSA
* Control group: healthy individuals

Exclusion Criteria:

* Diagnosis of heart disease
* Diagnosis of diabetes
* Diagnosis of any autonomic disorders
* Diagnosis of kidney disease
* Diagnosis of central sleep apnea
* Regular physical activity exceeding 30 minutes 3 days/week
* A body mass index ≥40 kg/m2
* Current or former use of a continuous positive airway pressure machine
* Current tobacco use
* Currently prescribed hormone replacement therapy
A Study to Evaluate TAR-210 Versus Single Agent Intravesical Cancer Treatment in Participants With Bladder Cancer

The main purpose of this study is to compare the disease-free survival between participants receiving treatment with TAR-210 versus investigator's choice of intravesical chemotherapy for treatment of intermediate-risk NMIBC.


Eligibility Criteria:
Inclusion Criteria:

* Have a histologically confirmed diagnosis (within 90 days of randomization) of IR-NMIBC with at least one of the following criteria fulfilled: a. Ta low grade (LG)/ Grade 1 (G1): primary or recurrent, b. Ta LG/G2: primary or recurrent and c. Greater than or equal to (\>=) 1 of the following risk factors: i. Multiple Ta LG tumors, ii. Solitary LG tumor \>= 3 cm, iii. Early recurrence (less than \[\<\] 1 year), iv. Frequent recurrence (greater than \[\>\] 1 per year), v. Recurrence after prior adjuvant intravesical treatment (single perioperative dose of chemotherapy does not fulfill this risk factor)
* Have a susceptible fibroblast growth factor receptor (FGFR) mutation or fusion either by urine testing or tumor tissue testing (from TURBT tissue), as determined by central or local testing
* Participants must be willing to undergo all study procedures (e.g., multiple cystoscopies from Screening through the end of study and TURBT for assessment of recurrence/progression) and receive the assigned treatment, including intravesical chemotherapy if randomized into that arm.
* Visible papillary disease must be fully resected prior to randomization and absence of disease must be documented at Screening cystoscopy
* Can have a prior or concurrent second malignancy (other than the disease under study) which natural history or treatment is unlikely to interfere with any study endpoints of safety or the efficacy of the study treatment
* Have an Eastern Cooperative Oncology Group performance status of 0 to 2

Exclusion Criteria:

* Known allergies, hypersensitivity, or intolerance to any study component or its excipients, including: a. Erdafitinib excipients; b.TAR-210 drug delivery system constituent materials ; c. urinary placement catheter materials; d. MMC or chemically related drugs; e. Gemcitabine or chemically related drugs
* Presence of any bladder or urethral anatomic feature (that is, urethral stricture) that, in the opinion of the investigator, may prevent the safe insertion, indwelling use, removal of TAR-210 or passage of a urethral catheter for intravesical chemotherapy
* Polyuria with recorded 24-hour urine volumes \> 4000 milliliters (mL)
* Current indwelling urinary catheters, however, intermittent catheterization is acceptable
* Had major surgery or had significant traumatic injury and/or not fully recovered within 4 weeks before first dose (TURBT is not considered major surgery)
Comparison by Neuromonitoring of Two Techniques of Tracheal Intubation in Patients With Unstable Cervical Spine

Patients who present with an unstable cervical spine following an accident need a general anesthesia for the necessary surgery.

Commonly, the management of the tracheal intubation is performed by a fiberoptic technique.

However, changes in equipment availability and quality may challenge the fiberoptic intubation technique.

The investigators wish to compare the tracheal intubations performed with the Airtraq in comparison with the fiberscopic technique.

Patients who present with an unstable cervical spine following an accident need a general anesthesia for the necessary surgery.

Commonly, the management of the tracheal intubation is performed by a fiberoptic technique (historic gold standard technique).

However, changes in equipment availability and quality may challenge the fiberoptic intubation technique.

We wish to compare the tracheal intubations performed with the Airtraq in comparison with the fiberscopic technique.

Primary outcomes will be the changes in neurophysiologic responses monitored by a neurophysiologist in 5 specific phases:

1. Basal potential (BM): neuromonitoring while the patient is anesthetized, no movements
2. Ventilation potential (VM): neuromonitoring while the patient is anesthetized and a bag-mask ventilation is performed
3. Intubation potential (IP): neuromonitoring while the patient is being intubated with one of the two randomized devices
4. Post Intubation (PI): neuromonitoring after the patient has been intubated
5. Post Positioning (PP): neuromonitoring after the patient has been properly positioned on the operating table and is ready for surgery

Eligibility Criteria:
Inclusion Criteria:

* unstable cervical spine due to a cervical vertebra fracture
* American Society of Anesthesia classification 1-3
* BMI \< 30 kg/m2
* patients necessitating a general anesthesia for surgery

Exclusion Criteria:

* patient refusal
* ASA \>3
* mouth opening \< 15mm
* patients with known history of previous orotracheal tumor surgery
Serum Hepcidin in Pregnant Women and the Association With Pregnancy Outcome

Hepcidin production is normally upregulated by iron stores, and in obesity has been shown to be overexpressed and correlated with low iron status. The increased hepcidin may restrain the iron release from the cells by affecting the expression of ferroportin, which probably associates with the development of diabetes complication. Firstly, investigator examines the difference of serum hepcidin and iron parameters between obese and non-obese pregnant women; secondly, the correlation between serum hepcidin and adverse maternal and neonatal outcomes in pregnant women will be tested.

This is a mono-center, observational, controlled study with 2 parallel groups (obese versus non-obese pregnant women). The study will be conducted at the University Hospital of Basel, Department of Obstetrics and Antenatal Care. A total of N=188 healthy pregnant women (expected 40% with BMI ≥ 30 kg/m2) will be recruited in the first trimester in our outpatients' department in order to have a total of 169 evaluable women, considering a drop-out rate of 10%. Serum hepcidin, iron and hematological parameters will be measured at 11-14, 24-28, 32-36 weeks of gestation and at labor. The blood pressure, weight, weight gain, BMI and smoking status will be examined at all visits. Blood samples will be measured in the University Hospital of Basel, Department of Laboratory Medicine. Recruitment will begin in January 2019.

Eligibility Criteria:
Inclusion Criteria:

* women with a BMI ≥ 18.5 kg/m2,
* maternal age ≥ 18 years,
* singleton pregnancy,
* gestational age at recruitment: 11-14 of gestational weeks,
* written informed consent.

Exclusion Criteria:

* pregnant women with a BMI\< 18.5 kg/m2,
* congenital anomaly of fetus,
* severe maternal diseases of heart, liver, kidney, cardiovascular system, gastrointestinal tract, neurologic disorders and psychiatric disorders.
The Incidence of Thyroid Cancer in 4474 Patients Treated for Hyperthyroidism or Goiter

Patients with hyperthyroidism and/or goiter are evaluated with blood samples and scintiscan before they are treated with radioiodine for their thyroid disease. Because the investigators do not get a histologically/final diagnosis the investigators want to make sure, that the patients treated do not have a thyroid cancer when treated.

The investigators have found that thyroid cancer is not overlooked.


Eligibility Criteria:
Inclusion Criteria:

* all patients treated with radioiodine
Efficacy and Safety of Combination Grazoprevir (MK-5172) + Elbasvir (MK-8742) + Ribavirin (RBV) in Genotype 2 Hepatitis C Infection (MK-5172-047)

This is a multi-site, open-label trial evaluating the safety and efficacy of 100 mg of grazoprevir (MK-5172) used in combination with or without 50 mg of elbasvir (MK-8742) and/or ribavirin (RBV) in treating non-cirrhotic treatment-naïve participants with chronic genotype (GT) 2, 4, 5, and 6 hepatitis C infection.

In Part A there is no randomization or stratification; all GT2 participants will be assigned to arm A1. In Part B, all GT2 participants will be assigned to Arm B1 and all participants with GT4, GT5 and GT6 will be randomized in a 1:1 ratio to either Arm 3 or Arm 4 with stratification by genotype.


Eligibility Criteria:
Inclusion Criteria:

Parts A and B: -Body weight ≥50 kg (111 lbs) and ≤ 125 kg (275 lbs) -Has absence of cirrhosis -Agrees to use two acceptable methods of birth control from at least 2 weeks prior to Day 1 and continue until at least 6 months after last dose of study drug, or longer if dictated by local regulations (for female participant who is of childbearing potential or male participant with female sexual partner who is of childbearing potential).

Part A only: -Has chronic HCV GT2 infection Part B only: -Has chronic HCV GT2, GT4, GT5, or GT6 infection

Exclusion Criteria:

Parts A and B:

-Is not treatment naïve (participant has had previous treatment with any interferon, RBV, approved or experimental direct acting antiviral(s), or other investigational therapies for HCV) -Is determined to be coinfected with hepatitis B virus (HBsAg positive) or HIV -Has evidence of, or is under evaluation for, hepatocellular carcinoma (HCC) -Has a clinical diagnosis of substance abuse including the following specified drugs within specified timeframes: Alcohol, intravenous drugs, inhalational, psychotropics, narcotics, cocaine use, prescription or over-the-counter drugs (within 1 year of the screening visit), is receiving opiate agonist substitution therapy (within 1 year of screening visit), or excessive historic marijuana use -Has evidence of active or suspected malignancy, or a history of malignancy, within the last 5 years -Female participant who is pregnant, lactating, expecting to conceive or donate eggs, or is of childbearing potential and unwilling to commit to two methods of birth control throughout treatment and after the completion of all treatment, or male participant who is planning to impregnate or provide sperm donation or has a female sexual partner of childbearing potential and is unwilling to commit to using a two methods of birth control throughout treatment and after the completion of all treatment -Has evidence or history of chronic hepatitis not caused by HCV, including but not limited to nonalcoholic steatohepatitis (NASH), drug-induced hepatitis, and autoimmune hepatitis. -Has uncontrolled diabetes (documented HbA1c \>8.5%)

Part A only:

-Has non GT2 HCV infection

Part B only:

-Has HCV infection with a genotype other than GT2, GT4, GT5 or GT6
Effect of IV Alanyl Glutamine on Healing of Pressure Ulcers in Critically Ill Patients

In this clinical trial, we will assess pressure ulcer healing rates in critically ill patients supplemented with IV Alanyl-Glutamine in comparison with critically ill patients not supplemented with alanyl-glutamine.

This clinical trial will include 200 Egyptian Critically ill patients with bed sores equal or more than grade II selected from ward or ICU at Air Force specialized Hospital. They will be classified into 2 groups:

* Group I: 100 critically ill patients will be enrolled on high protein diet and receiving IV alanyl Glutamine with dose 0.3 gm/kg/ day which equal 1.5 ml/kg/day of alanyl-glutamine until discharge from ICU, death (with duration of 2 weeks administration).
* Group II: 100 critically ill patients will be enrolled on high protein diet either enteral or parenteral but not receiving any glutamine supplementations.

Eligibility Criteria:
Inclusion Criteria:

* Patients with pressure ulcers stage 2,3 or 4, non-healing admitted to Air force specialized hospital for more than a week.

Exclusion Criteria:

* Patients with renal impairment (GFR \</= 30)
* Patients who require fluid restriction \< 1 Litre/day.
* Patients with liver cirrhosis. (Child B and C)
* Length of stay\< 2 weeks.
* Patients with deep tissue infection and/or requiring debridement of necrotic or sloughy tissue.
* Hemodynamically unstable patients. (On high dose of cardiac supports)
Academic Detailing About Asthma

General practices in the Capital Region of Denmark are offered a short educational visit and are randomized to either asthma (intervention) or another topic (control).

The change in prescription pattern from before to after the visit is compared between the intervention and control group.

General practices in the Capital Region of Denmark are offered a short educational visit. They are randomized by address to be offered a visit about either asthma (intervention) or another topic (control).

The prescription pattern of each general practice (as seen by their regional registration number \[ydernummer\]) who receive a visit is investigated.

The change in prescription pattern from before to after the visit is compared between the intervention and control group.

Eligibility Criteria:
Inclusion Criteria:

* General practices in the capital region of denmark, who owns a regional registration number \[ydernummer\]
* Want a visit
* Have time for a visit within the study period

Exclusion Criteria:

-
Exploration of eJaculatory Anatomy Concept Study (EJAC Study)

Ejaculatory dysfunctions (ED) are an important cause of postoperative dissatisfaction, which lead to a decrease in the intensity of orgasms in 50% of patients. ED is a cause for concern for almost a third of patients who need surgery. Surgical techniques have been developed to limit the occurrence of postoperative ED, but their results remain heterogeneous.

There are very few studies on the biomechanical anatomy of ejaculation. Ejaculation is a complex phenomenon involving different structures and in particular the Veru Montanum. This is the key element in the emission of ejaculate within the prostatic urethra. In addition, there is a structure located in the resection zone of the prostate adenoma. It has therefore been suggested that its resection was a primary source of ED.

A single observational study carried out in by Gil Vernet et al in 1994 evaluated on a single healthy 18-year-old volunteer the ejaculatory mechanism of expulsion using an endorectal probe recording the movements of the prostate, the bladder neck and of the proximal urethra during ejaculation.

A contemporary study of the biomechanics of the ejaculatory expulsion phase could confirm and improve understanding of the involvement of anatomical structures. The results of our study aim to adapt surgical techniques aimed at limiting the risk of postoperative ED.


Eligibility Criteria:
Inclusion Criteria:

* Affiliated subject or beneficiary of a social security scheme
* Subject agreeing to participate and having signed the free, informed consent.

Exclusion Criteria:

* Subject with ejaculatory dysfunction
* Subject with urinary dysfunction
* History of urinary or penile surgery
* Subject with untreated urinary tract infection
* History of chronic prostatitis
* Pathology making it impossible to introduce the endorectal probe or the ureteroscope
* History of colorectal inflammatory disease
* Recent intake (within 30 days) of drugs known to interfere with ejaculation
* History of intolerance or allergy to any of the drugs used in the study
* Subject participating in another clinical study
* Adults under guardianship, curatorship or other legal protection; deprived of liberty by judicial or administrative decision; Hospitalized without consent.
A Study to Investigate Tonlamarsen for the Treatment of Adults With Uncontrolled Hypertension

The purpose of this study is to evaluate the blood pressure-lowering effect of tonlamarsen in adult participants who, despite taking 2 or more antihypertensive medications, have not achieved their target blood pressure (BP).


Eligibility Criteria:
Key Inclusion Criteria:

* Age 18 to 80, body weight ≥ 50 kg
* Has uncontrolled hypertension while receiving between 2 and 5 antihypertensive medications prescribed for hypertension
* Has mean office seated systolic blood pressure \> 135 to ≤ 170 mmHg

Key Exclusion Criteria:

* Has known history of secondary hypertension
* Has documented history of poor adherence to antihypertensive medication
* Has unstable/underlying known cardiovascular disease
* Has abnormal thyroid function with clinical significance
Evaluating the Effectiveness of the Dissemination of Action Schools! BC

Childhood obesity is a major public health threat. Physical activity and healthy eating contribute to the maintenance of healthy weights. Individually oriented behaviour change programs may not be able to overcome the influence of what has been called an obesogenic environment. Action Schools! BC (AS! BC) used a socio-ecological approach to enhance opportunities for physical activity and healthy eating in elementary schools and created systemic change at the provincial level. AS! BC helps elementary schools customize action plans, based upon their local context, to contribute to the health and well-being of children and the school community. Pilot research showed that AS! BC was an effective and feasible model. The provincial dissemination of AS! BC has been launched and partners from across many sectors are involved to enhance the sharing of knowledge and increase the implementation of the AS! BC model across British Columbia. The dissemination provides an unprecedented opportunity for evaluating how changing the school environment can promoted healthy weights in children. The dissemination was evaluated using a cluster randomized design; 30 elementary schools (n = 1529 consented children) from four (out of five) provincial health authorities volunteered to participate.

The primary goals of the research are:

1. to determine if the Action Schools! BC (AS! BC) model is an effective approach to positively change school environments and health related behaviours of children from diverse geographical regions and cultural groups, and
2. to determine if the supports provided to schools or the community context influence the uptake and use of the AS! BC model.

This research will contribute to the science of obesity prevention and knowledge use as well as public health practice.


Eligibility Criteria:
Inclusion Criteria:

* Student attends a school that has agreed to participate in the study
* Student's classroom teacher has agreed to participate in the study
* Student is in grade 4 or 5 at start of study
* Student participates in regular physical education classes at school
* Student's parents provide consent

Exclusion Criteria:

* Student does not attend a school that has agreed to participate in the study
* Student's classroom teacher does not agree to participate in the study
* Student is not in grade 4 or 5 at start of study
* Student does not participate in regular physical education classes at school
* Student's parents do not provide consent