cyrilzakka/clinical-trials huggingface dataset:
Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants.

The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate (13vPnC) vaccine compared to 7-valent pneumococcal conjugate (Prevenar/Prevenar®, 7vPnC), when given concomitantly with Infanrix hexa at 2, 3, 4, months (infant series) and at 11-12 months of age (toddler dose) in Germany.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 2 months (56 to 112 days) at time of enrollment.
2. Available for entire study period and whose parent(s) or legal guardian(s) could be reached by telephone.
3. Healthy infant, as determined by medical history, physical examination, and judgment of the investigator.
4. Parent(s) or legal guardian(s) had to be able to complete all relevant study procedures during study participation.

Exclusion criteria:

1. Previous vaccination with licensed or investigational pneumococcal vaccine.
2. Previous vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, or hepatitis B vaccines.
3. A previous anaphylactic reaction to any vaccine or vaccine-related component.
4. Contraindication to vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, or hepatitis B, or pneumococcal vaccines.
5. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
6. Known or suspected immune deficiency or suppression.
7. History of culture-proven invasive disease caused by S pneumoniae or H influenzae type b.
8. Major known congenital malformation or serious chronic disorder.
9. Significant neurological disorder or history of seizure, including febrile seizure, or significant stable or evolving disorders, such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorders. Did not include resolving syndromes due to birth trauma such as Erb palsy.
10. Receipt of blood products or gamma-globulin (including hepatitis B immunoglobulin and monoclonal antibodies; eg, Synagis®).
11. Participation in another investigational trial. Participation in purely observational studies was acceptable.
12. Infant who was a direct descendant (eg, child or grandchild) of the study site personnel.
The Effectiveness of Guided Imagery for a Nonprofit's Employees

Primary Aim A. To determine if listening to prerecorded guided imagery 3 times per week for 4 weeks will reduce state anxiety, perceived stress, burnout, compassion fatigue, and vicarious trauma in Fronltine Service staff.

Primary Aim B. To determine if staff will continue to listen to guided imagery after the first 4 weeks of the study is over.

The purpose of this study is to compare the change in stress levels of employees who listen to prerecorded guided imagery to employees who take breaks, and to determine if employees are likely to adopt prerecorded guided imagery as a self-care tool.

Participants will be randomly assigned to either the guided imagery group or the control group. Members of the control group will be asked to take a 10 minute break 3 times per week for 4 weeks. Members of the guided imagery group will be asked to listen to one prerecorded guided imagery track 3 times per week for 4 weeks. All participants will fill out questionnaires before and after the 4 week period. All participants will fill out a short form before and after listening to each guided imagery, or before and after taking each break.

Phase 2: After phase 1 is complete, all participants will have the option to participate in phase 2 of the study. During phase 2, participants will receive a calendar and put a mark on every day that they listen to a guided imagery track. At the end of 4 weeks, participants will turn in the calendar.

Eligibility Criteria:
Inclusion Criteria:

* Staff of a nonprofit who work a minimum of three shifts per week
* Willing and able to use about 8-15 minutes of their lunch hours three times per week for for four weeks for the study

Exclusion Criteria:

* Staff members will be excluded from the study if they currently listen to guided imagery
* Those currently experiencing drug or alcohol abuse, suicidal ideation, or other serious mental health issue while not under the care of a trained mental health professional will also be excluded
Management of Patients With HF by Using Educational or Educational & Telephone or Telephone Interventions and Support in Cyprus

The current trial aims to examine the effectiveness of three different types of nursing interventions, on heart failure (HF) patients' quality of life and on HF outcomes, compared to the usual care. The interventions include promotion of self-care practices through education and support; they are either provided before discharge, post-discharge through telephone, or both.

The current trial aims to examine the effectiveness of three different types of nursing interventions, on heart failure (HF) patients' quality of life and on HF outcomes, compared to the usual care. The interventions include promotion of self-care practices through education and support. HF patients admitted in the public hospitals of the Cyprus Republic are screened for eligibility. Consented patients who meet the inclusion criteria are recruited before their discharge, and are randomly allocated to one of the four groups of the trial. Patients of the three intervention groups receive educational intervention and support, before discharge or post-discharge through telephone, or both. Patients of the fourth group receive the usual care (control group). The patients' follow up period is 3 months. The main purpose of the study is to determine whether the combination of predischarge education/support and tele-management is more efficient in improving HF outcomes, rather than the in-person and telephonic components alone. Outcome measures include quality of life and HF events (re-admissions and death) and time to HF event.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized adult patients with evidenced HF
* Planned for discharge
* NYHA class I-IV
* Greek speaking
* Able and willing to give informed consent

Exclusion Criteria:

* Severe mental illness or severly impaired cognitive function
* Patients that are to be transferred to nursing or rehabilitation homes
* Patients unable to be contacted via telephone
* Patients with active cancer
* Patients on dialysis
* Patients scheduled for surgery
* Patients recently undergone surgery (up to 3 months)
* Patients with less than 3 months life expectancy (end-stage)
* Patients with chronic degenerative diseases
Validating PROMIS Instruments in Congestive Heart Failure Patients Receiving a Heart Transplant

The Patient-Reported Outcomes Measurement Information System (PROMIS) is an NIH Roadmap initiative to develop a computerized system measuring patient-reported outcomes in respondents with a wide range of chronic diseases and demographic characteristics. In the first four years of its existence, the PROMIS network developed item banks for measuring patient-reported outcomes in the areas of pain, fatigue, emotional distress, physical function, and social functioning. During the item banking process, the PROMIS network conducted focus groups, individual cognitive interviews, and lexile (reading level) analyses to refine the meaning, clarity, and literacy demands of all items. The item banks were administered to over 20,000 respondents and calibrated using models based on item response theory (IRT). Using these IRT calibrations, computerized adaptive test (CAT) algorithms were developed and implemented. The network has designed a series of studies using clinical populations to evaluate the item attributes, examine their utility as CATs, and validate the item banks. More information on the PROMIS network can be found at www.nihpromis.org.

The purpose of this research study is to learn about the experience and impact of having congestive heart failure (CHF). In particular, we hope to develop better questionnaires that can measure heart failure patients' quality-of-life.

This project will assess the validity (including responsiveness) of selected Patient Reported Outcome Measurement Information System (PROMIS) instruments in patients with severe CHF who receive heart transplants. The following is a list of goals for this project:

* To estimate the responsiveness of PROMIS domain scores by comparing scores in patients with severe heart failure before and after a clinically significant event (heart transplant). The specific PROMIS domains assessed are physical functioning, fatigue, satisfaction with discretionary social activities, depression, and global health.
* To estimate the responsiveness of a disease-specific patient-reported outcome (PRO) measure, the Kansas City Cardiomyopathy Questionnaire (KCCQ), the Medical Outcomes Study Short Form-36 Vitality subscale (SF-36v2), and the Patient Health Questionnaire (PHQ-2).
* To collect cross-sectional and longitudinal data on traditional clinical measures of heart failure outcome (6-minute walk test and New York Heart Association \[NYHA\] class) that can inform the definition of a minimally important difference (MID) for the PROMIS domains of physical functioning, fatigue, satisfaction with discretionary social activities, depression, and global health.

Eligibility Criteria:
Inclusion Criteria:

* Heart failure had to represent the greatest medical limitation on daily function for the patient in the judgment of the attending cardiologist
* Ability to read, write, and speak in English
* Ability to understand and provide informed consent
* Placement on heart transplant registry (awaiting heart transplant surgery)

Exclusion Criteria:

* Current diagnosis of psychosis or dementia
Operative Versus Non-Operative Treatment of Clavicle Fracture in PolyTrauma

About 90% of chest injuries in America are due to blunt forces, mostly as a result of motor vehicle collisions and falls. Severity varies from minor bruising to severe chest injuries. For several years, clavicle ("collarbone") fractures have been treated without surgery (non-operatively), even when the fracture is out of place (displaced). Over the last few years, however, treatment has changed more towards surgical fixation (operative), because of the sometimes difficult healing in clavicle fractures that are displaced. Several research studies have shown that cases in which the clavicle fracture never heals completely (non-union) are more frequent after nonoperative treatment, compared to operative fixation. In those cases, surgery is still required, only later (secondary surgery). Further, clavicle malunion, in which the fracture heals but is still out of place) has been shown to be high after nonoperative treatment. Recent published research studies have shown better function, higher patient satisfaction, earlier return to activity (use of the arm) and decreased nonunion and malunion following surgery, also called open reduction/internal fixation. Despite recent published research, there is still a lack of agreement on when surgical fixation should be performed for clavicle fractures.

Patients with chest injuries often have clavicle fractures. Chest injuries can restrict patients' ability to breathe, cough, stand, walk and leave the hospital. Although it is unusual that chest injuries can be improved with surgery, patients with clavicle fractures and chest injuries might recover faster if the clavicle fractures were repaired.

Patients are being asked to take part in the study they have sustained a clavicle fracture associated with a chest injury with or without any other injury to the abdomen, or arms or legs. The aim of this study is to determine the difference in the hospital length of stay, intensive care unit length of stay, respiratory rehabilitation (recovery of good respiratory function), functional outcome, ability to become mobile again, complications and risk of dying in trauma patients with chest injury and clavicle fracture treated operatively versus non-operatively.


Eligibility Criteria:
Inclusion Criteria:

1. Patients males and females of any race.
2. Patients between ages 18 and 80
3. Patients who present with a unilateral clavicle fractures which are \>2cm displaced, \>2cm shortened, significantly comminuted, or are tenting the skin or which are bilateral and with associated chest injury and with or without additional injuries to the abdomen, pelvis or extremities will be approached for the study.

Exclusion Criteria:

1. Severe brain injury (GCS less than or equal to 13)
2. Intubated patients
3. Injury precluding operative fixation within 7 days of admission
4. Open clavicle fracture
5. Spinal cord injuries
6. Age \<18 or greater than or equal to 80
Assessment of the Effect of Clonidine for Cataract Surgery

Clonidine, an agonist for alfa2 pre-synaptic, has been shown to be an effective adjuvant therapy for acute postoperative pain and has been shown an effect in sedative, intra-ocular and blood pressure and arrhythmias.The objective of this study is evaluating the analgesic effect of clonidine and its repercussion on arterial and intraocular pressure and arrhythmias for cataract surgery.

After approved by the Ethical Committee and signed informed consent, 40 patients aged from 40 until 80 years undergoing cataract extraction will be randomized in two groups. Exclusion criteria will be myocardial ischemia, psychiatric disease, chronic pain, drugs dependency, chronic use of beta-blockage channel drugs. Group 2, patients will receive a single dose of 4mcg.kg-1 of clonidin2, 20 minutes before the surgical incision; group 1, patients will receive a sterile saline solution dose. Pain intensity will be assessed with the numeric rating scale. The antiarrythmic effect will be assessed with the continuous measure by Holter. The number of patients was calculated by Instat Graph® program. To detect difference in pain intensity of 3 between the groups by NRS, with 95% of power (estimated SD= 2.0), when the alpha level is set at 0.05, the sample should be of 20. Statistical analyses will be performed with parametric and nonparametric tests, considering the variety studied. The statistical program that will be utilized is Instat Graph®.

Eligibility Criteria:
Inclusion Criteria:

* cataract surgery
* topical anesthesia

Exclusion Criteria:

* myocardial ischemia
* psychiatric disease
* chronic pain
* drugs dependency
* use of beta-blockage channel drugs
Impact of Spices and Herbs on Endothelial Function

The general objective of the study is to investigate the effects of the daily consumption of spices and herbs for four (4) consecutive weeks in endothelial function and cardiovascular risk factors of men and postmenopausal women.

The purpose is to assess whether the polyphenol/antioxidant content of different spices will affect endothelial function and other cardiovascular risk factors.

Eligibility Criteria:
Inclusion Criteria:

* Age 40-70 yrs
* Men and postmenopausal women
* Waist girth \>102cm (men) or \>88cm (women)
* LDL-C \> 2.8 mmol/L
* Framingham 10-yr risk score \< 10%
* Marginal endothelial dysfunction
* Non smoker

Exclusion Criteria:

* Medication for lipid, hypertension, diabetes
* History of CVD, diabetes, other endocrines disorders
* Pre-menopausal women
* Alcohol consumption \> 1 drink per day
* Unusual dietary habits (e.g. vegetarism)
* Chronic use of supplements (estrogens, vitamins, minerals or flavonoids)
* Aversion or intolerance for spices and/or herbs
* Injury to fingers or amrs that would interfere with endothelial function measurement
Bioequivalence Between Two New Oral Nicotine Replacement Therapy Products and Nicorette® Microtab

The purpose of this study is to assess the bioequivalence between two new oral nicotine replacement therapy products and Nicorette® microtab.

The trial has a single-dose, randomized, crossover design and includes 84 subjects. The investigational products will be given as single doses at separate treatment visits. Periods without Nicotine Replacement Therapy (NRT), lasting for at least 36 hours, will separate treatment visits. At each treatment visit, blood for pharmacokinetic analyses will be sampled immediately before, and at 5, 10, 15, 20, 30, and 45 minutes, as well as at 1, 1.25, 1.5, 2, 3, 4, 6, 8, and 10 hours after start of product administration. The time until complete tablet dissolution will be recorded. Subjects will also be monitored to capture any adverse events that may occur. Treatment labels will be concealed from subjects and study personnel.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects, smoking at least 10 cigarettes daily during at least one year preceding inclusion and BMI between 17.5 and 30.0 kg/m2.
* Female participants of child-bearing potential are required to use a medically acceptable means of birth control.
* A personally signed and dated informed consent document, indicating that the subject has been informed of all pertinent aspects of the study.

Exclusion Criteria:

* Pregnancy, lactation or intended pregnancy.
* Treatment with an investigational product or donation or loss of blood within 3 month preceding the first dose of study medication.
(MIST1)-Part 1: Assessment & Feasibility of Post-Symptoms Evaluation

To increase patient safety culture in spinal manipulation therapy (SMT) this study will assess the ability to implement an active surveillance reporting system for a chiropractic teaching clinic and determining preliminary incidence of adverse events (AE) following SMT performed by the chiropractic interns. Adverse events defined for the primary outcome of this study is any new or worsening symptom following a chiropractic encounter.

Healthcare systems acknowledge the importance of patient safety including the reduction of preventable adverse events (AE). For healthcare providers who perform spinal manipulation therapy (SMT), the investigation of AEs remains in its infancy for several reasons including finding a reporting system that accurately collects AEs information, varied descriptions of AE's severity and occurrence frequency and the variable natural history of musculoskeletal conditions treated by SMT. Together, these factors act together to conspire against the implementation of systematic changes in SMT application that would result in improved patient care and safety.

In addition, it is vital that patient safety training initiates at the start of a healthcare worker's career. This pilot active surveillance study was designed to assess the feasibility of collecting data on patients' self-report of symptom changes as well as interns' report at a chiropractic teaching clinic.

Eligibility Criteria:
Inclusion Criteria:

* Patients at the Parker University Wellness Clinic
* Agreed to participate

Exclusion Criteria:

* none
Pharmacokinetic Study of Fondaparinux in Outpatients With Renal Dysfunction

To determine the appropriate dose and safety of a preventative dose of fondaparinux, an anticoagulant medication (blood thinner) in patients with kidney disease.

This study will evaluate the PK of fondaparinux in patients who have renal insufficiency. Fondaparinux is cleared from the body mainly by the kidneys. Therefore in patients with kidney diseases, full doses of fondaparinux could cause bleeding problems. The correct dose of fondaparinux that should be used in patients with kidney disease is not known. The purpose of this research is to determine the PK and safety of a preventative dose (2.5mg subcutaneously every other day) of fondaparinux for patients with kidney disease.

Eligibility Criteria:
Inclusion Criteria:

* Outpatients in the Medicine and Nephrology clinics who are 18 years or older,
* Outpatients in the Medicine and Nephrology clinics who have an estimated creatinine clearances between 20-30ml/min,
* Outpatients in the Medicine and Nephrology clinics who are able to give consent will be included.

Exclusion Criteria:

* anticoagulation therapy for thrombosis or other indication
* pregnant or breast-feeding
* hypersensitivity to fondaparinux
* subjects also will be excluded if there is concern for an increased risk of bleeding which includes the following:

  * known bleeding disorder (see Section 8. Hemostatic Assessment)
  * blood transfusion in the past 3 months
  * acute ulcer disease with past 3 months
  * platelet count \< 120,000 mm3
  * prolonged baseline prothrombin time (PT) or activated partial thromboplastin time (aPTT) above upper limit of normal laboratory range
  * major trauma or surgery within two weeks prior to enrollment
  * history of intracranial hemorrhage
Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BI 655130 in Healthy Male Volunteers

The aim of this study is to investigate the safety and tolerability of BI 655130 in healthy male subjects following single rising low, medium and high doses.


Eligibility Criteria:
Inclusion criteria:

* Healthy male subjects according to the investigators assessment, based on a complete medical history including a physical examination, vital signs (BP - Blood Pressure, PR - Puls Rate), 12-lead ECG (Electrocardiogram), and clinical laboratory tests
* Age of 18 to 45 years (incl.)
* BMI (Body Mass Index) of 18.5 to 29.9 kg/m2 (incl.)
* Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation

Exclusion criteria:

* Any finding in the medical examination (including BP - Blood Pressure, PR - Pulse Rate or ECG - Electrocardiogram) is deviating from normal and judged as clinically relevant by the investigator
* Repeated measurement of systolic blood pressure outside the range of 90 to 140 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 bpm
* Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
* Any evidence of a concomitant disease judged as clinically relevant by the investigator
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Cholecystectomy and/or surgery of the gastrointestinal tract (except appendectomy and simple hernia repair)
* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
* Further exclusion criteria apply
Effectiveness of Peripheral Blocks Under Ultrasound Control With and Without Electrical Nerve Stimulation

In modern anesthesiology, peripheral nerve blocks are performed using ultrasound control and electrical stimulation of peripheral nerves (PEN), or only ultrasound control or only PEN. The most effective methods are with the use of ultrasound control. Until now, the effectiveness of the sciatic nerve blockade by the subgluteal approach, performed only under ultrasound control without ESP, in comparison with the blockade of the sciatic nerve performed under ultrasound control with ESP, has not been established.

Research hypothesis: the blockade of the sciatic nerve by the subgluteal approach performed only under ultrasound control has the same effectiveness as the blockade performed under the ultrasound control with EPN.


Eligibility Criteria:
Inclusion Criteria:

* indication requiring anesthesia maintenance;
* patient's written consent about the type of anesthesia and possible complications of regional anesthesia

Exclusion Criteria:

* patient's refusal of application for the proposed form of anesthesia;
* patients younger than 18 years;
* patients weighing less than 50 kg;
* a physical status score of more than 3 determined by the American Society of Anesthesiologists (ASA);
* a history of allergic reactions to the drugs used;
* coagulopathies;
* infections of the skin at the injection site;
* neurological or neuromuscular diseases;
* severe liver diseases or kidney failures;
* an inability to cooperate with the patient.