cyrilzakka/clinical-trials huggingface dataset:
The Effect of Olfactory Mental Imagery and Cardiovascular Surgery

This study aims to examine the effect of olfactory mental imagery on physiological parameters, anxiety and symptoms after cardiovascular surgery.

This study was planned to be conducted as a prospective randomized controlled study in the Cardiovascular Surgery service of Istanbul Mehmet Akif Ersoy Thoracic and Cardiovascular Surgery Training and Research Hospital. The universe of the research; It will consist of patients who are hospitalized in the cardiovascular surgery service and who have undergone cardiovascular surgery. The sample will consist of a total of 90 patients hospitalized in the Cardiovascular Surgery service of the same hospital and meeting the inclusion criteria for the study.

Patient Diagnosis Form, Physiological Parameters Monitoring Form, State Anxiety Inventory and Cardiac Surgery Symptom Inventory will be used to collect data. Data will be collected on days 1, 2, 3 and 4 after surgery. In the study, patients will be divided into two groups: intervention (n = 45) and control (n = 45). The intervention group will perform breathing exercises with the olfactory mental imagery technique.


Eligibility Criteria:
Inclusion Criteria:

* Elective surgery is planned,
* There is no smell problem,
* No loss of visual and auditory functions,
* No previous hospital history,
* No serious head trauma or nasal injury,
* No known psychiatric disease or history of anxiolytic drug use,
* Olfactory, capable of mental imagery

Exclusion Criteria:

* Presence of decreased level of consciousness,
* Having drainage over 200 ml per hour,
* Ejection fraction less than 30 percent,
* People with lung disease such as atelectasis and pneumonia,
* Systolic blood pressure is below 90 mmHg,
* Patients whose pain control cannot be achieved
Study to Evaluate the Effectiveness of the Initial Specimen Diversion Device

This is a matched, open label study to evaluate the Initial Specimen Diversion Device (ISDD) in reducing the contamination rate in blood culture analysis. Blood culture data will be derived from inpatient and/or outpatient settings in a variety of hospital departments (e.g. ER, surgical, medical, etc.). Only samples that are collected via peripheral venipuncture may be included in this study. The ISDD will be compared to current laboratory practices for the collection of blood for culture purposes. Laboratory Standard Procedures (LSP) is defined as collection of venipuncture blood for culture without an initial diversion method to divert and sequester potential blood contaminants.


Eligibility Criteria:
Inclusion Criteria:

* Adults \>19 years old

Exclusion Criteria:

* Not a good candidate for direct-to-media (DTM) technique
Strategies to Improve Asthma and Treatment of Asthma in Canadians

Our study will enroll 644 randomly-selected Canadians who have been diagnosed with asthma by a physician within the previous five years. It will be determined what diagnostic tests were initially performed to make this diagnosis. Participants will undergo lung function testing over 6-8 weeks to determine their respiratory status and to confirm they have asthma. Participants may be followed up to one year depending on their test results.


Eligibility Criteria:
Inclusion Criteria:

1. Patient must have a recent diagnosis of asthma by a physician. Diagnosis of asthma must have occurred within 5 years prior to entry into the study.
2. Patient must be at least 18 years old.

Exclusion Criteria:

1. Patients in whom methacholine challenge is contraindicated

   * Patients using chronic oral prednisone.
   * Patients with heart attack or stroke within three previous months, and those with known aortic or cerebral aneurysms.
   * Pregnant patients (unknown effect of methacholine on the fetus) and breastfeeding patients (unknown whether methacholine is excreted in breast milk).
2. Patients unable to provide informed consent.
3. Patients not able to perform spirometry and/or methacholine challenge testing.
4. Patients who have a greater than 10 pack-year smoking history (this will exclude patients with possible COPD).
5. Patients who currently have active pulmonary Tuberculosis
6. Patients who have had eye surgery in the past 3 months or who have a detached retina
7. Patients involved in another interventional asthma study
Observance of Long Term Oxygen Therapy in Chronic Inspiratory Disease Patients

Long-term oxygen therapy (LTOT) is the reference treatment for chronic respiratory failure. This treatment is based on the principle of oxygen supplementation via a source to correct hypoxemia in patients. At present, adherence to this treatment is difficult to evaluate (reporting by patients), but the results of the literature show poor LTOT compliance. It is therefore important to accurately measure the oxygen consumption by patients and to understand the factors explaining LTOT compliance. The ultimate aim is to improve our patient management to make them more observant in order to improve the therapeutic efficacy of the treatment.


Eligibility Criteria:
Inclusion Criteria:

* chronic respiratory disease patients with chronic hypoxemia
* First prescribed long term oxygenotherapy

Exclusion Criteria:

* patients with NIV and CPAP
* vital pronostic \< 3 months
Treatment of Depressed Chronic Obstructive Pulmonary Disease Patients

Approximately 20% of patients with chronic obstructive pulmonary disease (COPD) have major depression, a condition that contributes to suffering but also to poor treatment adherence leading to increased disability and morbidity. This study investigates the effectiveness of a care management intervention aimed at facilitating adherence to a treatment algorithm based on the Agency for Health Care Policy and Research (AHCPR) guidelines. The investigators hypothesize that this intervention, in comparison to usual care, will increase the prescription of adequate antidepressant treatment by physicians, enhance treatment adherence by patients, and reduce depressive symptoms, suicide ideation, and disability at a 28-week follow-up period.


Eligibility Criteria:
Inclusion Criteria:

* Chronic obstructive pulmonary disease by American Thoracic Society criteria
* Major depression by DSM-IV criteria
* 17-item Hamilton score \>14
* English speaking

Exclusion Criteria:

* Inability to give informed consent
* MiniMental score \<24
* Aphasia
* Nursing home placement after discharge
Do Corticosteroid Injections During Total Knee Replacement Improve Early Clinical Results?

Prior to surgery, a pharmacist will randomly assign participating patients to one of two groups. One group will get an injection in the knee during surgery that contains medications to limit pain and an antibiotic. A second group will get an injection in the knee during surgery that contains the same pain medications and antibiotic along with a corticosteroid to control inflammation. Corticosteroids are anti-inflammatory medications, not to be confused with muscle-building anabolic steroids you may have heard about in the news. Each patient will have an equal chance of being in either of the two groups. This study will test the safety and efficacy of methylprednisolone acetate in the treatment of pain and inflammation following total knee replacement.

Information collected during your office visits:

The patient will be asked for a brief medical history so that we may determine if the patient can participate in the study. A member of our research team will ask the patient a series of questions about his/her knee. The patient will be asked to answer this series of questions a total of 4 times over the course of 1 year. Also, we will record how well the patient can bend and straighten your knee at these 4 office visits. We will have the patient rate the pain in his/her knee and ask the patient if he/she is satisfied with the surgery. If the patients have any complications, those will also be recorded. The patient will also have X-rays taken of the knee at the postoperative follow-up visits. This is the normal routine following total knee replacement. The X-rays will be read by the surgeon to help determine the success of the surgery.

Injection during total knee replacement surgery:

All patients will receive an injection containing bupivicaine HCl, morphine, epinephrine, clonidine, cefuroxime, and normal saline that will be placed directly into the knee during surgery. In addition, approximately half of the patients in the study will also receive methylprednisolone acetate as part of the injection.

Information being collected during your hospital stay:

During the hospital stay, information will be gathered for this study. A physical therapist will measure how well the patient can bend and straighten the knee. The amount of pain medication that was taken at the hospital will be recorded, and the number of days spent in the hospital will also be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Between ages of 18 and 95
* Has elected to undergo total knee replacement

Exclusion Criteria:

* Allergy to any of the medications used in the protocol
* History of kidney disease
* Rheumatoid arthritis
* Any systemic conditions associated with chronic pain
* History of deep knee sepsis in the affected extremity
* Unable to understand the questions used to obtain the Knee Society Score
* Minors and prisoners will be excluded from the study
VExUS Score and AKI in Critically Ill Adult patients-a Prospective Observational Study.

Introduction Renal perfusion is dependent on the renal perfusion pressure across the renal capillaries. Venous congestion due to excess fluid therapy can drastically reduce the renal perfusion pressure in spite of a normal mean arterial pressure. Increasing cumulative fluid balance during the ICU stay has been found to be associated with negative outcomes including acute kidney injury (AKI) and hospital mortality. Venous excess ultrasound (VExUS) to assess the Doppler studies of renal, hepatic and portal veins along with the inferior venacava has been shown to reliably predict the incidence of AKI in certain ICU patient population more specifically in cardiorenal syndrome. The aim of this study was to correlate the incidence of AKI and VExUS scores in a mixed ICU population and hence determine the contribution of venous congestion on the causation of AKI in a general ICU.

Methods:

The patients included who have AKI at admission or developed AKI during their ICU stay were included. The definition of AKI used for this study was as defined by Kidney Disease: Improving Global Outcomes (KDIGO). Point of care VExUS scans were done on each patient at inclusion (day 0), then each day for a total of 4 days (day 1, 2 and 3), till initiation of renal replacement therapy, death or discharge form the ICU. Correlation between VExUS grades and creatinine clearances was explored as the primary objective.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Admitted to the adult ICUs of TUTH (ICU A and ICU B)
* Admitting diagnosis of AKI or who developed AKI during their ICU stay

Exclusion Criteria:

* Pregnancy
* Diagnosed case of chronic kidney disease
* Diagnosed case of cirrhosis/ portal hypertension
* Arrhythmias which would interfere with the acquisition and interpretation of the Doppler waveforms
* Inferior venacava thrombus
* Poor window for assessment
Fecal Microbiota Therapy Versus Standard Therapy in NASH Related Cirrhosis.

Patients of NASH (Non Alcoholic Steatohepatitis) cirrhosis with current or prior histological evidence of steatosis or steatohepatitis admitted under the Department of Hepatology at Institute of Liver and Biliary Sciences, who meet the inclusion criteria and who provide informed consent will be included in the study.


Eligibility Criteria:
Inclusion Criteria:

1. Age more then 18 years.
2. All patients with cirrhosis with current or previous histological evidence of steatosis or steatohepatitis.
3. Histologic evidence of definite or probable NASH based upon a liver biopsy prior to enrollment and a NAFLD activity score (NAS) ≥5 with ≥1 in each component of the NAS score (steatosis, scored 0-3, ballooning degeneration, 0-2, and lobular inflammation, 0-3).
4. No past history of upper GI bleeding, ascites, hepatic encephalopathy

Exclusion Criteria:

1. Diagnosis of liver disease other than NASH cirrhosis
2. History of gastrointestinal bleeding, ascites, hepatic encephalopathy
3. Ongoing bacterial infection requiring antibiotic treatment.
4. Current or history of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to screening
5. Treatment with antibiotics or probiotics in the preceding 3 months.
6. Inability to safely obtain a liver biopsy or perform an upper GI endoscopy
7. Psychiatric disorder
8. HIV
9. Pregnant women
10. Patients on SBP (Spontaneous Bacterial Peritonitis) prophylaxis
Restrictive Versus Liberal Red Blood Cell Transfusion in Patients of Cirrhosis With Septic Shock

Consecutive cirrhotics who present to emergency department of ILBS with documented or suspected sepsis induced hypotension with Hb \<8 gm/dl will be randomly assigned to restrictive (Target Hb 7-8 gm/dl) to liberal (Target Hb 10-11 gm/dl) group in a 1:1 proportion At admission, all patients will undergo physical examination and baseline investigations to identify site of sepsis. Enrolled patients will be given PRBC-transfusion (Not more than two units of PRBC/day) when they reach their assigned trigger value (Hb 7-8 g/dl or 10-11 g/dl ) during the entire ICU stay. All other interventions will be at the discretion of clinicians.


Eligibility Criteria:
Inclusion Criteria:

1. Cirrhosis with septic shock.
2. Age \>18 years

Exclusion Criteria:

1. Previous severe adverse reaction with blood products,
2. Disseminated intravascular coagulopathy
3. HCC
4. Pregnancy
5. Malignancy
6. Active gastrointestinal bleeding
7. Intracranial bleeding
8. Chronic Kidney disease with Maintenance Hemodialysis
9. Pulmonary Edema
10. Congestive Heart Failure
11. Lack of informed consent
A Study to Evaluate the Pharmacodynamic Effects of Single Oral Doses of PF-06648671 on β-Amyloid (Aβ) Concentrations in Cerebrospinal Fluid (CSF)

This is phase 1 investigator-and-subject blind, sponsor open, randomized, placebo controlled, parallel study in healthy subjects to evaluate the pharmacodynamics effect of single oral doses of PF-06648671 on CSF Aβ concentrations using serial CSF sampling methodology.

This study is investigator-and-subject blind, sponsor open, randomized, placebo-controlled, parallel study in healthy subjects to evaluate central (CSF) and peripheral (plasma) pharmacodynamics effects (Abeta) over 36 hours post single doses of PF-06648671. Two cohorts will be run in sequential. the first cohort is to evaluate the Abeta effect at top dose of 300 mg PF-06648671 and second cohort is to evaluate the Abeta effect at top dose (if more subjects are required) and/or 1-2 lower doses

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects of non childbearing potential
* BMI of 17.5 to 30.5 kg/m2 and a total body weight \>50 kg (110 lbs)
* Evidence of a personally signed and dated informed consent document indicating that subject has been informed of all pertinent aspects of the study.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated asymptomatic, seasonal allergies at the time of dosing)
* Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study medication (whichever is longer)
* Subjects with a history of significant active bleeding, coagulation disorder or clinically significant finding on prothrombin time/ partial thromboplastin time/International Normalized Ratio (PT/PTT/INR) at Screening
* Subjects with lower spinal malformations (on physical examination), local spinal infection, or other abnormalities that would exclude puncture (LP)
* Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study
Alcohol Dependency Study: Combining Medication Treatment for Alcoholism

The purpose of this study is to learn whether ondansetron and topiramate either alone or in combination is safe and effective in the treatment of alcohol dependence. This 13 week out-patient clinical trial is randomized, double-blind, and placebo-controlled. There are post-study follow up visits 1, 2 and 3 months after the end of the study. Participants will receive ondansetron and topiramate either alone or in combination or a placebo coupled with psychotherapy.

This study is a 13 week clinical trial. During the 13 weeks participants receive placebo, ondansetron and topiramate alone or in combination. During the 13 weeks participants come to an outpatient clinic to receive the study medication, physical checks, and cognitive behavioral therapy. The duration of the weekly visit is 3 hours. There is a 1, 2, and 3 month post-study follow up visit. Screening for this study is initially done over the telephone and takes 15-20 minutes. If there is nothing found to make someone ineligible to participate, they come to the out-patient clinic for a more thorough in-clinic screening.

Eligibility Criteria:
Inclusion Criteria:

* Current diagnosis of alcohol dependence and drinking greater than or equal to 14 alcohol drinks/week for women and greater than or equal to 21 alcohol drinks/week for men in the last 30 days.
* Provide a written, informed consent.
* Good physical health and must weigh within at least 40 kg and no more than 140 kg.
* Literate in English and able to read, understand, follow instructions, and complete questionnaires accurately.
* Willingness to participate in behavioral treatments for alcoholism.
* Provide evidence of stable residence in the last month prior to enrollment in the study and have no plans to move during the next three months.

Exclusion Criteria:

Please contact site for additional information
A Phase 3 Study of Tezacaftor (VX-661) in Combination With Ivacaftor (VX-770) in Subjects Aged 12 Years and Older With Cystic Fibrosis (CF), Who Have One F508del-CFTR Mutation and a Second Mutation That Has Been Demonstrated to be Clinically Responsive to Ivacaftor

This is a Phase 3, randomized, double-blind, ivacaftor-controlled, parallel-group, multicenter study of tezacaftor in combination with ivacaftor in subjects aged 12 years and older with CF who are heterozygous for the F508del-CFTR mutation and a second CFTR allele with a gating defect that is clinically demonstrated to be ivacaftor responsive.


Eligibility Criteria:
Inclusion Criteria:

* Heterozygous for F508del-CFTR mutation and a second CFTR allele with a gating defect that is clinically demonstrated to be ivacaftor responsive
* FEV1 ≥40% and ≤90% of predicted normal for age, sex, and height during screening
* Stable CF disease as judged by the investigator.

Exclusion Criteria:

* History of any comorbidity that, in the opinion of the investigator, might confound the results of the study or pose an additional risk in administering study drug to the subject.
* Pregnant and nursing females (females of childbearing potential must have a negative pregnancy test at Screening and Week -4 Visits).
* Sexually active subjects of reproductive potential who are not willing to follow the contraception requirements
Effect of Biphasic Insulin Aspart 50 on Blood Glucose Control in Subjects With Type 2 Diabetes

This trial is conducted in Asia. The trial aims to investigate if the blood glucose control of biphasic insulin aspart 50 is at least as effective as treatment with biphasic insulin aspart 30 both in combination with metformin.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes
* Currently treated with premix human insulin twice daily with or without oral antidiabetic drugs for at least 3 months
* HbA1c (Glycosylated Haemoglobin A1c) between 7.5% - 12.0% (both inclusive)
* FPG (Fasting Plasma Glucose) higher than 7.0 mmol/L
* BMI (Body Mass Index) 23-40 kg/sq.m (both inclusive)

Exclusion Criteria:

* Metformin contraindications according to local practice
* Systemic use of TZDs (thiazolidinediones) for more than 1 month within 6 months prior to this trial
Peripheral Histamine 1 Receptor Blockade in IBS: Multicenter Trial

Purpose:

To evaluate the efficiency of Irritable Bowel Syndrome (IBS) patients treatment with the H1-receptor antagonist ebastine.

Design:

Double blind randomized placebo controlled trial. IBS patients receive a 12-weeks treatment with ebastine 20mg once daily or placebo (1:1 randomization).


Eligibility Criteria:
Inclusion Criteria:

* Irritable Bowel Syndrome (IBS) (ROME III criteria): subtype with diarrhea or mixed form
* age 18-65 years

Exclusion Criteria:

* IBS subtype with constipation
* medication: antidepressants or H1-receptor antagonists
* pregnancy, breast feeding
* co-morbidity: severe kidney- and/or liver disease or other gastrointestinal diseases
Nanocort in Acute Exacerbation of Relapsing-Remitting Multiple Sclerosis (MS)

Patients with an acute exacerbation of Relapsing-Remitting Multiple Sclerosis or with Clinically Isolated Syndrome receive either one single infusion of Nanocort or three daily infusions of SoluMedrol. Main objective is to assess the occurrence of new gadolinium-enhanced T1-weighted lesions at week 8 vs week 1 after treatment.


Eligibility Criteria:
INCLUSION criteria

* Diagnosis of RRMS (per McDonald criteria, 2005) with dissemination in time and space OR a diagnosis of CIS confirmed by MRI. Patients with CIS who only have optic neuritis will be excluded from this study
* A maximum Expanded Disability Status Scale (EDSS) score of ≤ 6
* New neurological symptoms or exacerbation of prior neurological symptoms of over 24 hours duration but \<7 days duration, verified by neurological examination

EXCLUSION criteria:

* Primary progressive MS.
* Secondary progressive MS without superimposed relapses.
* Received systemic corticosteroids within 4 weeks of screening for treatment of MS or other conditions.
* any contraindication for treatment with (systemic) corticosteroids
Evaluation of GW406381 in Treating Adults With Osteoarthritis Of The Knee

This study was designed to evaluate the effectiveness of GW406381 (a COX-2 inhibitor) in treating the signs and symptoms of osteoarthritis of the knee.

A Phase III, 12-week, Multicentre, Double-blind, Double-dummy, Randomised, Placebo- and Active Comparator-Controlled, Parallel Group study to investigate the Efficacy and Safety of GW406381 1mg, 5mg, 10mg, 25mg and 50mg administered orally once daily, in adults with Osteoarthritis of the knee (CXA30007).

Eligibility Criteria:
Inclusion criteria:

* Subjects have a primary diagnosis of osteoarthritis of the knee with symptom duration of at least 3 months.
* Use pain medication, such as a COX-2 inhibitor or NSAID (non-steroidal anti-inflammatory drug) at least 5 days per week.

Exclusion criteria:

* History of hypersensitivity or intolerance to pain medications.
* History of gastroduodenal perforations and/or obstructions.
* History of upper GI (gastrointestinal) ulceration within the previous 6 months.
* History of upper or lower GI bleeding within the previous year.
* History of inflammatory bowel disease.
* Currently take sucralfate or misoprostol.
* Currently taking aspirin daily for the heart.
* Other restrictions around the use medications apply and would need to be discussed.
* History of coronary artery disease, (angina, MI) or surgery.
* History of congestive heart failure or renal artery stenosis.
* History of stroke or transient ischemic attack.
* History of uncontrolled hypertension.