cyrilzakka/clinical-trials huggingface dataset:
The Use of Clonidine in Pain and Anxiety Associated With Acute Burn Injury in Children

Some of the children who suffer acute burn injury do not have adequate pain and anxiety management with the current regimen of scheduled opiates (morphine) and benzodiazepines (lorazepam). Other children have significant side effects or contraindications, such as constipation or over sedation, when taking these medications. Clonidine is known to reduce the need for morphine in the management of postoperative pain. The addition of clonidine to the pharmacological treatment of burn wound pain offers a possible adjunct to the standard opiate and benzodiazepines regimen. Clonidine has been used in children in both on a short-term basis (such as postoperative pain management) and on a long-term basis (such as the treatment of attention deficit hyperactivity disorder (ADHD)). This study tests the hypothesis that clonidine in a dose of 5 ug/kilo every 8 hours will be a useful adjunct to the management of pain and anxiety in the acutely burned child. All children will be treated by protocol with morphine (0.03mg/kilo) q4hr prn pain and lorazepam (0.03 mg/kilo) q 4 hours prn anxiety. In addition, after informed consent is obtained the children will be randomized to the addition clonidine or placebo. Pain and anxiety will be assessed using standard instruments blind to the medication being used on a daily basis Also the total dose of morphine and lorazepam during the 10 days of added clonidine or placebo will be recorded.. The pain rating, anxiety ratings, total morphine dose, and total lorazepam dose will be compared between the placebo and clonidine groups with a Student's t test. Once the blind is broken the child will be allowed to remain on the clonidine if it is beneficial. The second year of the grant will expand the age groups down to younger children and also begin to gain information about the effect of clonidine on the hypermetabolic state secondary to burn injury.


Eligibility Criteria:
Inclusion Criteria:

* Pain not controled by morphine
* Anxiety not controled by lorazepam
* Burn injuries of 20% or greater
* Burn type: scald or flame

Exclusion Criteria:

* Small burn injury
* Electrical burns
Effect of Beet Juice on Elite Swimmers.

Objective: To investigate whether an acute intake of Beetroot Juice (BJ) improved performance factors in a repeated swimming effort at maximum speed in elite swimmers.

Methods: A total of 13 elite swimmers (6 girls and 7 boys) participated in this randomised, double-blind study. In 2 different trials, the swimmers ingested an injection of Beet-It (70 ml placebo (PL) or an injection of Beet-It 70 ml beetroot juice (BJ)) 3 hours before undergoing a 6x100m crawl intermittent maximal speed performance test.


Eligibility Criteria:
Inclusion Criteria:

* national and international level swimmers
* healthy swimmers
* no breakfast
* 48 hours with restricted diet of: other sports supplements and beetroot-rich foods

Exclusion Criteria:

* be on medication
* having had breakfast
* have brushed your teeth
Insulin Resistance and Central Nervous System (CNS) Function in Type 2 Diabetes

The purpose of this study is to examine the effects of treating insulin resistance on memory and attention, brain glucose utilization, and proteins in spinal fluid.

Insulin resistant conditions such as impaired glucose tolerance, type 2 diabetes mellitus, and hyperinsulinemia have been associated with an increased risk for memory decline and for Alzheimer's disease. The main study will determine whether treatment with pioglitazone or nateglinide will improve verbal memory and selective attention for older adults with impaired glucose tolerance or mild type 2 diabetes. The main study will also characterize changes in blood concentrations of insulin, inflammatory markers, and the beta-amyloid peptides that are related to Alzheimer's disease. In one sub-study, participants will undergo brain positron emission tomography (PET) imaging before and after 16 weeks of treatment with pioglitazone, nateglinide, or placebo. The purpose of this sub-study is to determine the effects of treatment on brain glucose utilization. In a second sub-study, participants will undergo a lumbar puncture procedure before and after treatment. The purpose of this sub-study is to determine the effects of treatment on spinal fluid concentrations of insulin, inflammatory markers, and beta-amyloid peptides. Together these main and sub-studies should characterize the effects of insulin resistance on cognition and suggest a mechanism by which insulin resistant conditions increase risk for memory decline and for Alzheimer's disease.

Eligibility Criteria:
Inclusion Criteria:

* Impaired glucose tolerance OR mild type 2 diabetes mellitus OR normal blood sugar regulation
* Stable weight and activity level

Exclusion Criteria:

* Medications for diabetes
* Dementia
* Medications with known effects on memory
* Serious neurologic disease or head trauma
* Serious systemic illness (e.g., renal failure or uncontrolled hypertension)
* Serious psychiatric illness (e.g., schizophrenia or bipolar disorder)
* Allergy to pioglitazone or nateglinide
Investigating the Efficacy and Safety ICATIBANT For The Treatment of Patients With SARS-CoV-2 (COVID-19) Infection

To study the efficacy and safety of icatibant in adult patients admitted to hospitalization units for pneumonia caused by COVID-19, without mechanical ventilation, 10±1 days after starting treatment or discharge from hospital if this occurs before 10 days.


Eligibility Criteria:
Inclusion Criteria:

1. adult patients (18 years or older), both sexes
2. Sars-CoV-2 infection confirmed by PCR less than 4 days before randomization
3. hospitalized with a diagnosis of SARS-CoV-2 pneumonia
4. radiographic evidence of pulmonary infiltrates
5. grade 4 or 5 on the ordinal scale for the evaluation of the patient's clinical condition
6. pO2/FiO2 \<380
7. men and women of childbearing age who have heterosexual relations must be agreement to use the safe method(s) of contraception
8. obtaining the informed consent of the patient or the legal representative.

Exclusion Criteria:

1. imminent death (life expectancy less than 72h)
2. known hypersensitivity or known adverse reactions to the study drug, or its metabolites or excipients of the formulation
3. invasive mechanical ventilation
4. participation in any other clinical trial
5. ALT or AST \> 5 x ULN
6. creatinine clearance \<50 mL/min using the Cockcroft-Gault formula for participants '18 years old \[Cockcroft 1976\]
7. patients with recent acute coronary syndrome (\<1 month)
8. patients with a history of stroke
9. positive pregnancy test
10. pregnant or lactating woman
Effects of Early Sleep After Action Observation and Motor Imagery After Metacarpal Fracture Surgery

The study aimed to investigate the effects of early sleep after action observation and motor imagery (AOMI) training sessions on manual dexterity in patients with hand immobilization after surgical fixation for metacarpals and phalanges fractures.

Fifty-one patients with hand immobilization for surgical fixation of IV or V metacarpals or first phalanges fractures will be randomized into AOMI-sleep (n=17), AOMI-control (n=17), and Control (n=17) group. AOMI-sleep and AOMI-control groups will perform an AOMI-training before sleeping or in the morning respectively, while Control group will be asked to observe landscape video-clips. Participants will be assessed for manual dexterity, hand range of motion, hand disability and quality of life at baseline before and after the training and at 1 month after the training end.

The study aimed to investigate the effects of early sleep after action observation and motor imagery (AOMI) training sessions on manual dexterity in patients with hand immobilization after surgical fixation for metacarpals and phalanges fractures.

Fifty-one patients with right hand immobilization for surgical fixation of IV or V metacarpals or first phalanges fractures will be randomized into an AOMI-sleep (n=17), AOMI-control (n=17), and Control (n=17) group. AOMI-sleep and AOMI-control groups will perform a 2-week AOMI-training including transitive manual dexterity tasks between 8:00 and 10:00 p.m. or between 8:00 and 10:00 a.m. respectively, while Control group participants will be asked to observe landscape video-clips between 8:00 and 10:00 p.m. Participants will be assessed for manual dexterity (Purdue Pegboard Test and kinematic indexes during Nine Hole Peg Test), hand range of motion (Total Active Motion) hand disability (Quick-DASH) and quality of life (EQ5D) at baseline (1 week after surgery), training end (3 weeks after surgery) and 1 month after the training end (7 weeks after surgery).

Eligibility Criteria:
Inclusion Criteria:

* Surgical fixation for IV or V MTC or P1 fracture at the level of the right hand
* Age 18-40 years old
* Right-hand dominance

Exclusion Criteria:

* Damage to additional hand structure requiring surgery (e.g. tendons, ligaments and nerves)
* Occurrence of left upper limb injuries
* Post-surgical complications (e.g. CPRS)
* Immobilization \<12 or \>30 days
* Diagnosis of neurological/musculoskeletal conditions
* Sports or activities requiring advanced manual skills or sleep deprivation
* History of psychiatric disorders
* Sleep disorders (e.g. insomnia, OSAS, REN or Non-REM behavioural disorders)
* Medication affecting the physiological sleep pattern
A Pharmacokinetic Study of Tedizolid Phosphate in Pediatric Participants With Gram-Positive Infections (MK-1986-014)

The primary objectives of this study are to describe the single-dose, and multiple dose pharmacokinetics (PK) of intravenous (IV) tedizolid phosphate, or a single dose oral suspension of tedizolid phosphate, when administered to pediatric participants, full-term neonates, and preterm neonates.

Per protocol, PK analysis in Part A Group 1 will be conducted across ages in Cohorts 1 and 2 combined: Part A Group 1 Cohort 1 + Cohort 2: 28 days to \<24 months.

Eligibility Criteria:
Inclusion Criteria:

* Is receiving prophylaxis for or has a confirmed or suspected infection with gram-positive bacteria and receiving concurrent antibiotic treatment with gram -positive antibacterial activity.
* Is at least 1 kg in weight.
* Is in stable condition as determined from medical history, physical examination, electrocardiogram (ECG), vital signs, and clinical laboratory evaluations.
* Has no clinically significant ECG abnormalities.
* Has sufficient vascular access to receive trial drug, and allow for required blood draws.
* Is able to receive medication by mouth, for those dosed with oral suspension; dose administration via feeding tube is acceptable.

Exclusion Criteria:

* Has a history of seizures, other than febrile seizures, clinically significant cardiac arrhythmia or condition, moderate or severe renal impairment, or any physical condition that could interfere with the interpretation of the study results, as determined by the Investigator.
* Has used rifampin within 14 days prior to dosing.
* Has used or will be using proton pump inhibitors, H2 blockers, or antacids (for participants in Part B, i.e, oral suspension dose) at any time from 24 hours prior to dosing through 24 hours after dosing..
* Has a recent (3-month) history or current infection with viral hepatitis or other significant hepatic disease.
* Has a history of drug allergy or hypersensitivity to oxazolidinones.
* Has had significant blood loss.
* Need for oral administration of topotecan, rosuvastatin, irinotecan, or methotrexate during administration of oral study drug.
* Used monoamine oxidase inhibitors (MAOIs) or serotonergic agents including tricyclic antidepressants, selective serotonin reuptake inhibitors (SSRIs), and serotonin 5-hydroxytryptamine receptor agonists (triptans), meperidine, or buspirone within 14 days prior to study, or planned use while on study.
* Has received another investigational product within the 30 days prior to enrollment.
Genistein and Endometrial Hyperplasia

The aim of this study is to verify the anti-estrogenic activity of Genistein, on the "non atypical endometrial hyperplasia", in premenopausal women.

Although isoflavones alone (example: Genistein) have weak estrogenic effects on endometrial stromal and glandular cells, it was demonstrated, in several research efforts, that in the presence of E2 they act as antiestrogens.

Considered that endometrial hyperplasia is due to strong and extended estrogenic stimulation, not offset by a proportionate amount of progesterone, we suppose that genistein could be therapeutic in these cases inducing a decrease of the hyperplasia and a change from the proliferative to a secretory phase of the endometrium.

Eligibility Criteria:
Inclusion Criteria:

* Premenopausal women
* Age \> = 44 years
* Dysfunctional uterine bleeding
* No treatment with other hormonal drugs (estrogen, progesterone)
* No local or general pathology negatively influenced by administration of genistein or progesterone
* No intrauterine pathologies (polyps, myomas)
* A "non atypical endometrial hyperplasia", confirmed by hysteroscopy with biopsy and histological examination

Exclusion Criteria:

* All the other conditions
Glucose Optimisation With Angiotensin II Antagonist Losartan (GOAAL)

To determine if angiotensin-II AT-1 receptor blockade(ARB) may improve insulin sensitivity assessed by the hyperinsulinaemic isoglycaemic glucose clamp, more than CCB therapy at a comparable dose with regards to the blood pressure-lowering effect.

Patients with hypertension have an increased prevalence of insulin resistance and an increased risk of developing diabetes mellitus with ageing. Different antihypertensive regimens have varying effects on glucose metabolism and the development of diabetes mellitus. In a double-blind,randomized cross-over study we aim to compare the metabolic effects of 10 mg amlodipine and 100 mg losartan + 5 mg amlodipine in patients with hypertension and other risk factors for the metabolic syndrome.

After a 4-week open label amlodipine 5 mg run-in period, all hypertensive patient will be randomized to additional treatment with either amlodipine 5 mg or losartan 100 mg for 8 weeks. At the end of this 8-week treatment-period we will do a physical examination, laboratory-tests, hyperinsulinaemic isoglycaemic glucose clamp, heart rate variability and baroreflex sensitivity measurements. Following this is a 4-week wash-out phase where the subjects continue open label 5 mg amlodipine, before crossed over to the opposite treatment regimen for another 8 week before the final examination.

Eligibility Criteria:
Inclusion Criteria:

* Essential hypertension with diastolic blood pressure 95-110 mmHg and systolic blood pressure \< 180 mmHg
* Previously untreated hypertension or treated with monotherapy (but not with ACE-inhibitors or Angiotensin II-receptor blockers)
* Impaired glucose tolerance or impaired fasting glucose (fasting plasma glucose; 6.1-7.0 mmol/l (110-126 mg/dl)
* Age over 18
* Informed consent
* Any one of these: Microalbuminuria (urin excretion \>20 microg/min), dyslipidemia (HDL-cholesterol \<0.9 mmol/l(35 mg/dl), Triglycerides \> 1.7 mmol/l (150 mg/dl), waist to hip-ratio \>0.9 in men and \>0.85 in women, BMI \>28 kg/m2.

Exclusion Criteria:

* Previous or current use of ACE-inhibitors or Angiotensin II-receptor blockers
* Previous or current antidiabetic medications
* "Brittle" pre-diabetes where the investigator anticipates pharmacological treatment within next 6 months
* Hypertensive patients where the investigator anticipates polytherapy within next 6 months
* Female patient who is pregnant or nursing or planning pregnancy within the duration of the study
Differences in the Presentation Outcome and Response to Treatment Between Never- Smokers and Smokers With NSCLC

We wish to discover if there is a difference in the presentation, response to treatment and survival of never- smokers with lung cancer as compared to ever- smokers.

We also plan to obtain tumor specimens to compare the genetic and proteomic expression between smokers and never smokers

Lung cancer is the most lethal of all malignant tumors affecting humans. In the United States alone an estimated 160,440 patients died of lung cancer 2004\[1\]. It is well known that tobacco smoking is a major risk factor and accounts for the majority of all lung cancer cases. But there is a sub group of patients with lung cancer who have never actively smoked tobacco. This group exhibits certain unique characteristics which separates them from lung cancer in smokers. It has been shown that never- smokers with adenocarcinoma have better outcomes in terms of overall survival as well as lung cancer specific survival when compared to current smokers with adenocarcinoma of the lung\[2\]. Also patients who are current smokers at diagnosis have decreased survival when compared to people who quit smoking\[3\]. The improved survival in never smokers could be due to several reasons. Such as increased incidence of co-morbid factors in smokers as result of exposure to tobacco smoke, differences in metabolism of chemotherapeutic agents or a reflection of differences in the underlying molecular biology of the tumor.

It has been demonstrated that chromosomal abnormalities are common in lung cancer patients with a smoking history when compared to never- smokers\[4\]. Gene mutations such as p53 mutations are more frequent in never- smokers than in previous smokers\[5\]. In addition mutations that are specific only to lung cancer in never smokers have been discovered, demonstrating the possibility of a separate or overlapping carcinogenesis pathway for lung cancer in never smokers vs. smokers \[6\].

Eligibility Criteria:
Inclusion Criteria:

* Age Range 18-88, diagnosed with non- small cell lung cancer between Jan 1 1996 and Dec 31 2002.

Exclusion Criteria:

* Patients diagnosed prior to Dec 31, 1995 and after Jan 1, 2003
Response of Older Adults to Influenza Vaccination With Regard to Cytomegalovirus (CMV) Status

The study is being undertaken to evaluate responses to seasonal influenza vaccine in older adults with respect to their CMV status. CMV is cytomegalovirus and is an organism that infects many people, but does not usually cause disease in the individual unless they are immunocompromised i.e. their immune system is not working well such as in the case of HIV infection. CMV is believed to have infected up to 80% of individuals in the age group we will be looking at in our study and we are interested in whether this infection affects their responses to vaccination.

Human cytomegalovirus (HCMV) is an important pathogen or disease-causing virus, which can result in disease in the unborn child as well as in individuals whose immune systems are not working properly such as those with HIV or who are receiving some treatments for cancer, where the body's ability to fight infection is not as good as in healthy people. HCMV infects the majority of the population, yet rarely causes overt disease which would limit the capacity of the host to transmit HCMV to others. This virus is thought to be millions of years old and because of this we think that it has evolved over time to become very efficient at evading the immune system. This means it has become very efficient at moving through the human population and resulting in humans devoting more immunological resources to controlling this virus than to any other. Recent studies have reported that the immune system does work less efficiently in older people, especially in elderly patients with CMV antibodies compared to age matched controls who did not have CMV antibodies.

It is well recognized that responses to vaccination are generally lower in older populations compared to children, so they may be thought to be immunologically in a suboptimal position. It is proposed that this may be as a result of diversion of key factors in the immune system to address CMV infection, the incidence of which increases with age. This study will allow assessment of responses to licensed seasonal influenza vaccine with respect to age and CMV status and will provide baseline information as a proof of principle on which a larger study will be designed.

Eligibility Criteria:
Inclusion Criteria:

* No contraindications to vaccination as specified in the "Green Book" - Immunisation Against Infectious Disease, HMSO.
* Written informed consent obtained
* Subject aged no less than 50 years 0 days and no older than 79 years and 364 days at enrollment.
Dispersion of Local Anesthetic on the Erector Spinae Plane Block in Cadavers

This study aims to better understand the dispersion of local anesthetic on the Erector Spinae Block, a new technique developed for analgesia. It consists on injection of local anesthetic around the posterior muscles of the Spine. In this study, the investigators will make the injection with coloring solution on cadavers and by dissection will note the dispersion of the solution according to injectate volume. The investigators hypothesize more volume allows bigger spread and will allow new indications of this technique in perioperative analgesia and treatment of chronic Pain

The study's methodology will include performing ultrasound guided erector spinae block in cadavers included in the study according to eligibility criteria. After signing of written consent form, the participants will be randomized on the height of the block (vertebral level - T3, T12 and L4) and the volume to be injected (10, 20 and 30ml). The block will be performed by experienced physicians on the technique by ultrasound guidance and fixed pressure measured with an in-line pressure monitor (15 psi) with the cadaver in the lateral position. The cadavers will be submitted to autopsy by standard thoracoabdominal midline incision, with the viscera removed for analysis. The cadavers will have their paraspinal muscles removed (quadratus lumborum and psoas major), the medial parietal pleura opened and the number of levels with colored solution registered, noting the spread to ventral rami of spinal nerves and to the paravertebral space.

Eligibility Criteria:
Inclusion Criteria:

* Fresh Cadavers (not subject to formaldehyde fixation process or frozen \> 24h)
* Age \> 18 years
* Written informed consent signed by responsible party
* Height \> 150cm and \< 190cm

Exclusion Criteria:

* Previous spinal surgery
* Severe spinal deformity
* BMI \> 35 kg/m2
* Absence of a responsible party to sign the written informed consent
A Study to Assess Efficacy, Safety and Pharmacokinetics of a Tacrolimus New Oral Formulation (MR4) in BMT Recipients

A study to assess efficacy, safety and pharmacokinetics of a tacrolimus new oral formulation (MR4) in de novo bone marrow transplant recipients


Eligibility Criteria:
Inclusion Criteria:

* Bone marrow transplantation patients aged 20-54 except for transplanted from genetically HLA matched sibling donor.
* The patient had been fully informed.

Exclusion Criteria:

* The patient had severe impaired hepatic function.
* The patient had impaired renal function.
* The patient had existing complication of severe cardiac dysfunction.
* The patient had severe impaired pulmonary function.
Genetic Mechanisms in Human Hypertension Renin-angiotensin-aldosterone System (RAAS) Inhibition Study

The purpose of this study is to develop an approach to provide personalized medicine to individuals who have hypertension (high blood pressure). The investigators plan to use people's genetic characteristics (traits) to determine what medication they should use to lower their blood pressure most effectively. The investigators will give individuals one of two medications to treat hypertension (lisinopril or atenolol). The investigators believe that depending on the individuals genetic background one medication will work better in lowering their blood pressure.


Eligibility Criteria:
Inclusion Criteria:

* Male and female hypertensive participants who were previously studied in SCOR program.

Exclusion Criteria:

* Diabetes
* Taking other medications beside thyroid or estrogen supplements.