cyrilzakka/clinical-trials huggingface dataset:
The Pharmacokinetics of Dexmedetomidine in Children

This study is designed to identify the plasma concentrations which are required to achieve adequate sedation, using a Ramsay Sedation Scale. As an alpha 2 agonist, dexmedetomidine can elicit hemodynamic changes, fluctuations in blood pressure and heart rate. This study will attempt to determine whether these changes can be predicted by plasma concentrations.

Dexmedetomidine, an alpha2 agonist is currently the standard of care for sedation for diagnostic (MRI, CT and Nuclear Medicine) radiological studies at Boston Children's Hospital. Although it is FDA approved for sedation, its pharmacokinetics in children has not been carefully studied with prospective studies. The plasma concentration of dexmedetomidine necessary to achieve and maintain adequate sedation for motionless conditions for a MRI study has not been determined which is the purpose of this study.

Eligibility Criteria:
Inclusion Criteria:

* Age 3 - 11.9 years

  * 2 age groups: 3.0 - 5.9 years, 6.0 - 11.9 years
* Patients will be equally distributed within each age group
* Meets criteria to receive dexmedetomidine sedation for MRI:

  * Active, uncontrolled gastroesophageal reflux - an aspiration risk
  * Active, uncontrolled vomiting - an aspiration risk
  * Current (or within past 3 months) history of apnea requiring an apnea monitor
  * Active, current respiratory issues that are different from the baseline status (pneumonia,exacerbation of asthma, bronchiolitis, respiratory syncytial virus)
  * Unstable cardiac status (life threatening arrhythmias, abnormal cardiac anatomy,significant cardiac dysfunction)
  * Craniofacial anomaly, which could make it difficult to effectively establish a mask airway for positive pressure ventilation if needed
  * Current use of digoxin
  * Moya Moya Disease
  * New-onset stroke
  * Provide written consent to take part in the research study

Exclusion Criteria:

* Do not meet established sedation criteria
* History of allergy, intolerance, or reaction to dexmedetomidine or hypersensitivity
* Previous diagnosis of hepatic insufficiency/failure or a serum glutamate pyruvate transaminase level \> 2 times the normal limit determined by Children's Hospital Boston (TCH)
* Current diagnosis of renal insufficiency/failure or a current serum creatinine level \> 1.5 times the normal limit determined by TCH
* Have received digoxin in the past (no time limit)
* Received phenobarbital, clonidine or valproic acid within 30 days
* Current, repaired or risk of Moya-Moya disease
* Recent stroke (cerebrovascular accident) within past 6 months
* Uncontrolled hypertension
* Concomitant use of beta antagonist, or calcium channel blocker
* Participated in a clinical investigation within the past three months
Detection of Health Risk Situations in the Anesthesia Consultation.

This study aims to estimate the proportion of patients seen in the anesthesiology consultation for planned surgery in whom a previously unknown health risk situation is detected (e.g., obesity, anemia, etc.).


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged 18 to 50 years.

  * Indication for elective surgery.
  * In-person preoperative evaluation in the scheduled Anesthesiology consultation.

Exclusion Criteria:

* Indication for non-deferrable urgent surgery.
* Pregnant women.
* Pre-surgical visit outside the anesthesia consultation.
* Incomplete preoperative evaluation, as indicated in the final section (preoperative judgment) of the anesthesia visit report.
Metabolome Analysis in Patients With Rheumatoid Arthritis

The aim of this study is to investigate discriminant metabolites in urine from patients with rheumatoid arthritis (RA) from healthy individuals. Then we determine if the patient's metabolic fingerprint could predict the development or flare-up of RA.

Compare metabolites between RA patients and healthy individuals.

1. Collection urine sample
2. Assessing urine metabolites by 1H NMR spectroscopy
3. Analyzing the relationships between metabolites and clinical variables

Eligibility Criteria:
Inclusion Criteria:

* All patients with rheumatoid arthritis meet 2010 American College of Rheumatology/European League against Rheumatism classification criteria.

Exclusion Criteria:

* Comorbid with other autoimmune diseases
* Confirmed with amyloidosis
* Chronic kidney disease (estimated GFR \< 60 ml/min/1.73m2)
* Chronic liver disease
* Thyroid disease
* Pregnancy
* Solid tumor/hematologic malignancy within 5 years
Adjuvant Use of Neostigmine in Sepsis and Septic Shock.

The inflammatory response represents an important, central component of sepsis. Therefore, it is believed that blunting inflammation will decrease mortality. In vivo test series with mice that had undergone cecal ligation and puncture (recognized sepsis model), physostigmine salicylate significantly inhibited the release of various cytokines (tumor necrosis factor α, interleukin1β, and interleukin 6). These results were similar to those obtained by vagus nerve stimulation.

In animal sepsis model using physostigmine not only decreased inflammation but also, diminished the decrease in blood pressure following infection.

Animals treated with the peripheral choline esterase inhibitor neostigmine showed no difference compared with physostigmine-treated animals. Therefore, this study aims to investigate the efficacy of choline esterase inhibitors as adjuvant therapy in patients with sepsis or septic shock. Outcome measures include: percentage reduction in procalcitonin blood level, percentage of patients achieving significant reduction in procalcitonin levels, Mean Sequential Organ Failure Assessment score, percentage decrease in lactate dehydrogenase blood level, length of stay in hospital intensive care unit, and in hospital mortality.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-85 years.
* Patients diagnosed with sepsis or septic shock according to Third International Consensus Definitions for Sepsis and Septic Shock mentioned above.
* Patients who have ≥ 2 of the following four criteria plus documented infection:

  1. Fever ≥ 38 °C or hypothermia ≤ 36 °C.
  2. Tachycardia ≥ 100/min.
  3. Tachypnea ≥ 20/min or hyperventilation.
  4. Leukocytosis ≥ 12000/mm3 or leukopenia ≤ 4000/mm3 or ≥ 10% immature neutrophils in the differential count.

Exclusion criteria:

* Known hypersensitivity to choline esterase inhibitors.
* Known absolute contra-indications against choline esterase inhibitors such as, myotonic dystrophy; depolarization block by depolarizing muscle relaxants; intoxication by irreversibly acting cholinesterase inhibitors; closed craniocerebral trauma; obstruction in the gastrointestinal tract (mechanical constipation); obstruction in the urinary tract (mechanical urinary retention)
* Known relative contraindications against choline esterase inhibitors: bronchial asthma; bradycardia; AV-conduction disturbances.
* Having undergone solid organ transplantation.
* Pregnant and lactating women.
* Participation in another clinical trial.
* Presence of primary or concomitant illness, impending death.
Long-term Risk of Second Primary Malignancies for Chronic Myeloid Leukaemia in the French Imatinib-based SPIRIT Trial

Imatinib is a tyrosine kinase inhibitor that has improved the prognosis of patients with chronic myeloid leukemia (CML). CML has become a chronic disease requiring long-term administration of imatinib. Late adverse effects were initially unknown. Since 2005, imatinib has been suspected to increase the risk of second primary malignancies (SPM). Through the French "STI571 Prospective Randomized Trial" (SPIRIT), we studied the incidence of SPM after more than 20 years of exposure, and treatment strategies for CML and SPM at their occurrence.


Eligibility Criteria:
Inclusion Criteria:

* Included in the French SPIRIT trial

Exclusion Criteria:

* None
Study to Learn More About the Onset of Effect of Iberogast in Patients Suffering From Abnormal Stomach and Intestine Function

Several studies have been done on the efficacy of the herbal medicine Iberogast. In this study researcher want to learn more about the time needed for Iberogast to start to work after the patient took the drug. This study plans to enroll 300 adult male and female patients suffering from disturbance of stomach and intestine normal function and treated by their doctor with Iberogast drops. Patients will be asked to document on a diary card the changes of symptom severity of the stomach and intestine complaints and the time needed for the symptoms to improve after drug intake. At the end of the study the treating doctor and the patients will be asked about the overall changes of symptoms. In addition information on the safety of the drug and how well the drug is tolerated by the patients will be collected


Eligibility Criteria:
Inclusion criteria:

At the discretion of physician under the instructions of Rome III criteria concerning functional gastrointestinal symptoms as well as the summary of product characteristics of Iberogast

Exclusion criteria:

Therapeutic necessity
Role of Kinesiotape Over Dorsi Flexors Muscles on Balance in Children With Spastic Diplegia

To detect the effect of kinesio -tape on balance in children with spastic diplegia.

The use of Kinesio Taping might influence the cutaneous receptors of the sensory motor system, resulting in the improvement of voluntary control and coordination in a physiotherapy program for children with CP. (Yasukawa et al., 2006).

The study will be conducted To investigate the effect of kinesiotape applied on dorsi fexors muscles on improving balance in spastic diplegic children .

Eligibility Criteria:
Inclusion Criteria:

* • Thirty children with spastic diplegia of both genders participated in this study.

  * Theywere selected from the out-patient clinic, faculty of physical therapy, Cairo University.
  * Children height not less than 1 meter to be able to see the screen of the biodex balance system.
  * Their agehad ranged from 4 to 8 years.
  * All patients have mild spasticity according to modified Aschwar scale grade 1 \&1+ (Alhusaini, 2010) presented in (Appendix I).
  * All patients wereable to stand alone GMFM presented in (Appendix II).
  * They could understand and follow instructions.
  * All Children used Ankle Foot Orthosis.

Exclusion Criteria:

* • Children with visual or auditory problems.

  * Children with positive sensitivity to kinesiotape.
  * Children with irrivisable muscle contracture at the calf muscles.
Glin4: Assessment of the Glycemic Responses to Nutritional Products

This study assesses the glycemic responses to nutritional products. During a study visit fasted subjects will consume one serving of the reference product or the test product. Capillary blood samples will be taken at baseline and at several time-points over a 2-hr period. Several nutritional products will be tested over time.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 and ≤ 65 years
2. Body mass index (BMI) between 18.5 and 27 kg/m²

Exclusion Criteria:

1. Baseline fasting Glucose ≥6.1 at screening visit
2. Known history of gastrointestinal disease, bariatric surgery, AIDS, hepatitis, a history or presence of clinically important endocrine (including Type 1 or Type 2 diabetes mellitus), or any condition which might, in the opinion of the medical director either: 1) make participation dangerous to the subject or to others, or 2)affect the results.
3. Use of medications known to influence carbohydrate metabolism, gastrointestinal function or appetite, including, but not limited to adrenergic blockers, diuretics, thiazolidinediones, metformin and systemic corticosteroids within 4 weeks of the screening visit, or any medication which might, in the opinion of the medical director either: 1) make participation dangerous to the subject or to others, or 2) affect the results.
4. Major trauma or surgical event within 3 months of screening.
5. Known intolerance, sensitivity or allergy to test products.
6. Extreme dietary habits, as judged by the Investigator (i.e. Atkins diet, very high protein diets, etc.).
7. History of cancer in the prior two years, except for non-melanoma skin cancer.
Impact of Armodafinil on Neurocognition and Cognitive Fatigue in Multiple Sclerosis (MS)

The investigation will involve a double-blind, placebo controlled, cross-over study examining the efficacy of armodafinil in improving neurocognitive functioning and reducing cognitive fatigue in MS. Patients who report MS-related cognitive difficulties and perform at least 1 standard deviation below the mean on a brief cognitive screen will be given a thorough neuropsychological evaluation at two time points. Half of the patients will be randomized to receive a single oral dose of lactose placebo prior to the first testing session. After a washout period of one week, they will then receive 250mg of armodafinil prior to a second testing session (P/A group). The other half of patients will be randomized to receive the active drug first. After a washout period of one week, they will receive the placebo prior to a second testing session (A/P group). As plasma levels of armodafinil peak between 2-4 hours after administration, participants will be asked to take a single 250mg capsule 2 hours prior to the scheduled testing sessions.


Eligibility Criteria:
Inclusion Criteria:

* relapsing remitting and secondary progressive MS patients
* between the ages of 18 and 60
* report cognitive difficulties.
* perform 1 sd or more below cut-off on cognitive screening measure

Exclusion Criteria:

* no history of alcohol/drug abuse or nervous system disorder other than MS
* no sensory impairments that might interfere significantly with cognitive testing
* no developmental history of learning disability or attention-deficit/hyperactivity disorder
* no medical condition other than MS that could substantially affect cognition
* no relapse and/or corticosteroid use within four weeks of assessment;
* no current use of modafinil, armodafinil or other psychostimulants.
Take A Stand for Workplace Health: A Sit-stand Workstation Project Evaluation

The purpose of this study is to examine the contribution of sit-stand workstations to total daily physical activity in a multi-component office-based 12 month intervention.

This study adopts a randomised control trial design and is mixed methods (qualitative and quantitative). The outcome data from the trial is quantitative. Alongside this a qualitative process evaluation will be conducted to inform the intervention, explain trial results and understand the intervention implementation and context (Cathain et al. 2014). Two worksites will participate in this study, in line with COCHRANE recommendations for randomised control trials.

Eligibility Criteria:
Inclusion Criteria:

* Must be a full-time employee on a fixed term contract for at least 18 months at one of the two worksites involved in the study (Macmillan Cancer Support, Public Health England)
* Must engage in primarily desk-based work
* Must have their own desk (i.e. does not hot desk) Must be primarily office based (i.e. not working from home)
* Must have no plans to leave the organisation for an extended period (e.g. holiday \> 4 weeks or secondment) or finitely before the anticipated study end date (January 2016)

Exclusion Criteria:

* Have engaged in standing-based desk work in the month prior to the start of the study
* Have been advised against standing by a health professional; or be unable to stand
* Work for the Macmillan Support Line
The Effect of Connective Tissue Massage in Patients With Migraine

The aim of this study was to investigate the effectiveness of connective tissue massage in patients with migraine


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Migraine Disease
* Being volunteer

Exclusion Criteria:

* Serious psychiatric problems with mental and / or communication problems Neurological, inflammatory or endocrine disease
Efficacy of Etoricoxib 60 mg in Modifying Pain Hypersensitivity in People With Knee Osteoarthritis

This study aims to better understand the way in which painful osteoarthritis affects different people and whether an anti-inflammatory medication such as Arcoxia (etoricoxib) can help to modify this pain. The study will use questionnaires and tests of pain sensitivity to identify arthritis sufferers with more widespread, nerve-type pain and then to investigate whether a daily dose of Arcoxia is more effective than a placebo pill in reducing these symptoms and improving functional movements. The study will also be comparing the same test results of a small group of subjects without knee pain.


Eligibility Criteria:
Inclusion Criteria:

* unilateral diagnosis of Knee OA \> 6 months
* knee pain \> 4/10 on WOMAC pain subscale
* if pain in contralateral knee, no greater than "mild"
* no other significant joint involvement
* ARA functional Class I, II or III
* no arthroscopy or injections into index knee in last 6 months

Exclusion Criteria:

* history of systemic inflammatory or chronic pain disorders (especially fibromyalgia)
* neurological deficit
* recent (\< 6 months) lower limb surgery
* allergic reaction to NSAIDs or aspirin
* skin allergies, dermatitis
* contraindications to Cox-2 inhibitors:

  * congestive heart failure (NYHA II-IV)
  * unstable hypertension
  * ischaemic heart disease
  * peripheral artery disease
  * cerebrovascular disease including CABG or angioplasty within 1 year
* severe hepatic dysfunction
* active GI bleeding or peptic ulceration
* reduced creatinine clearance \< 30 mL/min
* current use of high dose (\> 325 mg daily) aspirin
Delayed Recompression for Decompression Sickness

Decompression sickness syndrome (DCS) is caused by microbubbles forming in blood vessels or tissues during a reduction in environmental pressure (decompression). Bubbles have mechanical, embolic and biochemical effects with manifestations ranging from none to fatal. By reducing bubble volume and hastening inert gas elimination, recompression therapy with hyperbaric treatment remains the main therapy for DCS. The most common hyperbaric protocol used, is based on US Navy Treatment table 6, started as early as possible after surfacing. The outcome of hyperbaric therapy varies with reported complete resolution in 13%-63% of the patients suffering from severe DCS, and in 73%-100% of the patients with mild-moderate DCS.

The significance of time to recompression is controversial. It has been suggested that early hyperbaric treatment improves the outcome by decreasing bubble size and avoiding further tissue injury. However, in recent studies time to recompression had very little effect on clinical recovery. Moreover, the time beyond which hyperbaric treatment isn't effective has not been determined yet.

The aim of this study was to evaluate the clinical outcome of delayed hyperbaric treatment to divers who referred to tertiary care hospital hyperbaric unit, more than 48 hours after surfacing. The clinical outcome of the delayed hyperbaric treatments was compared to early treatments given at the same hyperbaric unit.

From January 2000 to February 2014, 204 divers were treated for DCS in the institute of Hyperbaric Medicine, Assaf Harofeh Medical Center, Israel.

The data will be collected retrospectively from medical records and include age, sex, diving experience, maximal depth, DCS possible cause, DCS type, symptoms, time from surfacing to symptoms onset, time from surfacing to recompression, recompression table, additional treatment after the first recompression and treatment outcome.

Statistical analysis will be done using univariant analysis was performed using Spearman's correlation and Chi-Square in categoric variabales, independent t-test in numeric variables. This will be performed in SPSS v.21 software.

Eligibility Criteria:
Inclusion Criteria:

* Decompression sickness after diving
* Recompression Treatment between 2000-2014 in Assaf HaRofe medical center hyperbaric institute

Exclusion Criteria:

* Decompression sickness excluded
Pharmacokinetic, Safety, and Efficacy Effects of Oral LBH589 on Dextromethorphan in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer or Malignant Pleural Mesothelioma

This study will investigate the effect of oral LBH589 on dextromethorphan, a CYP2D6 substrate, and to assess safety and efficacy of oral LBH589 when used with this co-medication in advanced stage NSCLC or malignant pleural mesothelioma patients


Eligibility Criteria:
Inclusion criteria:

1. Age ≥ 18 years
2. Must have histologically or cytologically confirmed advanced or metastatic incurable solid tumor as documented by CT or MRI that has progressed on or following standard therapies
3. Must have failed prior standard systemic therapy
4. Must have at least one measurable and/or non-measurable lesion as defined by RECIST criteria
5. Baseline MUGA or ECHO must demonstrate LVEF ≥ the lower limit of the institutional normal.
6. Written informed consent obtained prior to any screening procedures
7. Willingness to have multiple blood draws
8. Ability to swallow capsules or tablets

Exclusion criteria:

1. Uncontrolled brain metastases
2. Prior treatment with an HDAC inhibitor
3. Presence of clinically detectable third-space fluid collections (e.g., ascites or pleural effusions) that can not be controlled by drainage or other procedures prior to study entry
4. Concomitant use of any anti-cancer therapy, including radiation therapy
5. Significant cardiac disease
6. Concomitant use of drugs with a risk of causing torsades de pointes
7. Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral LBH589
8. Previous use of monoamine oxidase inhibitors (e.g. clorgyline, iproniazid, isocarboxazid, moclobemide, sibutramine, phenelzine, tranylcypromine) within 14 days prior to the first dose of dextromethorphan
Liraglutide In Overweight Patients With Type 1 Diabetes

The purpose of this study is to examine the effects of liraglutide (a drug used to treat type 2 diabetes) on glucose (sugar) control over the 26 week study period when used in addition to insulin.


Eligibility Criteria:
Inclusion Criteria:

1) Type 1 Diabetes on continuous subcutaneous insulin infusion (CSII; also known as insulin pump) or multiple (four or more) injections of insulin per day. 2) Using a continuous glucose monitoring device (CGM) or regularly measuring their blood sugars four times daily. 3) HbA1c of less than 8.5%. 4) Well versed with carbohydrate counting. 5) Age 18-75 years 6) BMI≥ 25kg/m2 7) Age at diagnosis of type 1 diabetes should be \<30 years. 8) evidence of auto-immunity to beta cells (GAD-65 and islet cell antibody screen)

Exclusion Criteria:

1)Type 1 diabetes for less than 6 months; 2)Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass, surgery or coronary angioplasty) in the previous four weeks; 3)Hepatic disease (transaminase \> 3 times normal) or cirrhosis; 4)Renal impairment (serum eGFR \<30ml/min/1.73m2); 5)HIV or Hepatitis B or C positive status; 6)Participation in any other concurrent clinical trial; 7)Any other life-threatening, non-cardiac disease; 8)Use of an investigational agent or therapeutic regimen within 30 days of study. 9) history of pancreatitis 10) pregnancy 11) inability to give informed consent 12) history of gastroparesis 13)history of medullary thyroid carcinoma or MEN 2 syndrome. 14) Smokers will be advised not to change their amount of smoking for the duration of the study; 15) Use of any agent other than insulin for treatment of diabetes (metformin, pramlintide or thiazolidinediones.
Analgesic Effects of Intravenous Paracetamol on Labor Pain

The purpose of this study is to determine whether intravenous paracetamol is effective in treating labor pain.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists physical class I-II
* term patients (≥ 37 weeks of gestation)

Exclusion Criteria:

* previous cesarean section
* hypertension, pre-eclampsia, eclampsia
* intra-uterine growth retardation
* intrauterine fetal death
* morbid obesity (body mass index ≥ 35)
* allergy to any of the study drugs