cyrilzakka/clinical-trials huggingface dataset:
MPP Programming Study

The purpose of this study is to compare the efficacy of cardiac resynchronization therapy (CRT) device programming with hemodynamic measurements to device programming without hemodynamic measurements.


Eligibility Criteria:
Inclusion Criteria:

* Be scheduled to undergo implant of a St. Jude Medical (SJM) CRT-D system with approved standard indication by ESC/EHRA Guidelines
* Have the ability to provide informed consent for study participation and be willing and able to comply with the Clinical Investigation Plan (CIP) described evaluations and follow-up schedule

Exclusion Criteria:

* Have high ventricular rate (\>90 bpm) during persistent or permanent atrial fibrillation despite available treatment
* Be in NYHA IV functional class
* Have a recent myocardial infarction within 40 days prior to enrollment
* Have undergone cardiac bypass surgery or coronary revascularization procedure within 3 months prior to enrollment or be scheduled for such procedures in the following 7 months
* Have had a recent CVA or TIA within 3 months prior to enrollment
* Have had intravenous inotropic support in the last 30 days
* Be less than 18 years of age
* Be pregnant or planning to become pregnant during the duration of the investigation.
Target Attainment of TDM-guided Infusion of Piperacillin/Tazobactam and Cefepim in Critically Ill Patients

Although alternative dosing strategies can improve antimicrobial exposure in critically ill patients, the high PK variability in this population means that some may still receive sub-optimal antibiotic exposure leading to unfavourable clinical outcomes.

Therapeutic drug management (TDM) guided dosing is the only safe and effective way to ensure that all critically ill patients achieve therapeutic antimicrobial exposures and to minimise the likelihood of toxicity.

For experts, TDM should be a standard of care, in particular for β-lactams. Nevertheless, because of the assay method for β-lactams and the need for bioanalytical experts, delays in obtaining results frequently occurred. These barriers, combined with difficulties in the interpretation of TDM results, need to be addressed in order to increase its routine utilization. Consequently, study aiming at identify which subgroup of patients or infection are more likely to benefit from TDM are urgently warranted This prospective observational study aimed at evaluating target attainment of piperacillin/tazobactam (PIP/TAZ) and cefepim (CEF) with the use of a Therapeutic Drug Monitoring (TDM) in critically patients during the routine care


Eligibility Criteria:
Inclusion Criteria:

* Minimun age limits 18 years
* Critically ill patient receiving piperacillin or cefepim administered continuously

Exclusion Criteria:

* Beta lactam allergy
* Pregnancy
* Age less than 18 years
Comparison by Transoesophageal Assessement of Systolic Right Ventricle Function Measures in Perioperative Care of Pulmonary Transplant.

The aim of the study is to describe the early adaptation of the right ventricle assessed by echocardiography to change of pulmonary circulation secondary to pulmonary transplantation.

Secondary objectives include change of haemodynamics measured by transpulmonary thermodilution and evolution of right heart function in terms of primary graft dysfunction grading.


Eligibility Criteria:
Inclusion Criteria:

* Adult (over 18 years)
* Patient affiliated to a social protection scheme insurance
* Patient was informed of the study and w gave their consent
* Patient on the lung transplant list
* Patient eligible for a pulmonary transplantation after decision of a multidisciplinary team
* Patients with chronic lung disease with parenchymal dysfunctions (Chronic obstructive pulmonary disease or COPD, alpha-1 antitrypsin deficiency, cystic fibrosis, pulmonary fibrosis, bronchiolitis obliterans organizing pneumonia or BOOP)

Exclusion Criteria:d

* Minor patients
* Patient under judicial protection, under guardianship
* Patient in exclusion period (determined by a previous study or in progress)
* Patient participating in parallel in another clinical trial that may interfere with the results of the study
* Inability to give informed patient information (emergency, understanding difficulties, etc ...)
* The refusal of patient consent
* The use of cardiopulmonary bypass during lung transplantation
* Uni-pulmonary transplant
* A transplant for idiopathic or primary pulmonary hypertension
* The presence of a cons-indication for transesophageal echocardiography:

  o Absolute contraindications:
* Abnormalities of the esophagus: stenosis, tumor, diverticulum perforation, active bleeding

  o Relative contraindications:
* ancient cervicothoracic irradiation history (\> 10 years)
* recent upper gastrointestinal bleeding history
* presence of esophageal varices ≥ grade II
* zero cervical mobility
* Reflux Esophagitis
* Severe coagulation disorders
* Pregnancy / Breastfeeding
Effect of Early Removal of Wound Drains After Mastectomy or Lymph Node Dissection

To compare early drain removal versus output-based drain removal, assessing the following end-points:

Clinical : risk of seroma and infection, woundhealing, duration of wound care and drain output versus volume of seroma.

Quality of life : drain-induced pain, discomfort due to seroma or drain, sleep disturbance and implications on daily activities.

Cost-effectiveness


Eligibility Criteria:
Inclusion Criteria:

* Patient scheduled for breast cancer surgery with placement of suction drainage
* Female or male
* Age \> 18 years
* All stages of disease (inclusion is independent of TNM-classification)

Exclusion Criteria:

* Patients scheduled for breast cancer surgery without placement of suction drains
* No informed consent: Patient refuses participation OR is not able to give a written informed consent
Will Erectile Dysfunction Increase the Risk of Prostate Cancer

The rationale for investigating the hypothesis that there is an association between erectile dysfunction (ED) and the subsequent development of prostate cancer is based on three assumptions: 1) baseline ED is common in most if not all of the cross-sectional studies in men with prostate cancer; 2) the development of ED and prostate cancer may have certain shared common risk factors; and 3) the use of testosterone for the treatment of ED has been suspected to be associated with prostate cancer development. Controversy exists over whether men with ED have an increased risk of subsequent prostate cancer. Few studies have evaluated the risk of developing prostate cancer for men with ED. The investigators, therefore, conducted a population-based longitudinal study with eight years' follow-up to examine this association and to evaluate the magnitude of the risk.


Eligibility Criteria:
Inclusion Criteria:

* men 50 years and older with no pre-existing prostate cancer

Exclusion Criteria:

* less than 50 years old
* pre-existing prostate cancer
A Comparison of CPR Outcomes Between Traditional and Endomorphic Manikins With and Without Equipment

The study's research design is a randomized experiment. 50 emergency responders (emergency medical responders, emergency medical technicians, advanced emergency medical technicians, and paramedics) will be recruited for this research. All data collection will take place in Lab 14 of the Benson Bunker Fieldhouse or a professional, confidential location of the participant's choosing.

Prior to CPR performance, participants will be given an informed consent form to sign. The form will be explained in detail by the researcher collecting data. After obtaining informed consent, participants will be asked to fill out a demographic questionnaire to collect information such as age, gender, years of emergency responder experience/employment, and years of CPR certification. Demographic information provided by participants will be utilized in data analysis. The demographics form should take approximately five minutes to complete. Participants will be randomly assigned to the four trials they will partake in and instructed via oral script (one for over and one for under football shoulder pads) to perform four-trials total of three-minute single-rescuer CPR on both a traditional CPR manikin and "Fat Old Fred" (bariatric) CPR manikin. CPR must be performed in accordance with the American Heart Association's 2015 CPR Guidelines and participants will use a CPRmeter 2 device to collect data to determine the quality of CPR components (chest compression depth/recoil, compression rate, CPR compression duration, mean depth, mean rate, and total number of compressions). The entire study session should take 25 to 30 minutes to complete.


Eligibility Criteria:
Inclusion Criteria:

* Emergency responders employed through the ambulance stations located in North Dakota and Minnesota
* Current CPR/first-aid certification
* Active clinician, educator, or administrator.

Exclusion Criteria:

* Cardiovascular conditions inhibiting CPR performance
* Respiratory conditions inhibiting CPR performance
* Musculoskeletal conditions inhibiting CPR performance
Radical Gastrectomy With/Without HIPEC in Advanced Gastric Cancer Patients

Patients with histological proven advanced gastric cancer (including cancer of the esophagogastric junction (AEG) without evidence of distant metastases, who fulfill the inclusion and exclusion criteria, can be recruited in this study. There are two treatment groups (A and B). The D2 radical gastrectomy will be applied in both groups. Patients randomized into group B will be treated with an intraperitoneal (in the abdominal cavity) chemoperfusion with cisplatin(75mg/m2 max 150mg/m2 max 5L ). Patients randomized into group A will not accept intraperitoneal chemoperfusion. Patients in both groups receive 6 cycles of postoperative chemotherapy (SOX or XELOX) within 4-12 weeks after the surgical procedure and are followed up for 24 months.

The objective of the trial is to compare the treatment of patients with advanced gastric cancer without evidence of distant metastases treated with D2 radical gastrectomy and intraperitoneal chemoperfusion (HIPEC) and postoperative chemotherapy (Group B) and patients treated with D2 radical gastrectomy alone and postoperative chemotherapy (Group A).

The hypothesis of the trial is that D2 radical gastrectomy with intraperitoneal chemoperfusion (Group B) is superior to D2 radical gastrectomy (Group A) in terms of overall survival.

The trial is designed as a prospective, randomized, open, multicenter and parallel group study.

Eligibility Criteria:
Inclusion Criteria:

* Histological proved diagnosis of peritoneal metastasized gastric cancer including carcinoma of the AEG.
* No evidence of distant metastases
* preoperative examination (CT/MRI) demonstrated resectable gastricc cancer with T3-T4 stage
* Written informed consent is obtained prior to commencement of trial treatment

Exclusion Criteria:

* Any previous chemotherapy or radiotherapy, and any investigational treatment for gastric cancer
* Active systemic infections
* Patients with known interstitial lung disease with New York Heart Association classification \> 2
* Serious cardiac dysrhythmia or condition, New York Heart Association classification of III or IV, congestive cardiac failure
* cardiac arrhythmia
* Inadequate renal function at the beginning of the trial, defined as GFR less than \<60 ml/min
* Inadequate liver function at the beginning of the trial, defined as Bilirubin \>1.5 times ULN
* Inadequate bone marrow function at the beginning of the trial, defined as platelet count less than \<150 GPT/L or neutrophil granulocyte count less than \<1.5 GPT/
* Active vaccination within 6 weeks prior to randomisation
* Active hepatitis B or C infection
* Female patients who are pregnant or breast feeding
* Missing of capacity to contract
* contraindication to the drugs which are used in the trial
* Participation in another therapeutic clinical trial
Concomitant Utilization of Radio Frequency Energy for Atrial Fibrillation (CURE-AF) Study

This investigation is a prospective, nonrandomized multicenter clinical trial evaluating the outcome of patients with atrial fibrillation (AF) requiring concomitant open heart surgery plus the Cardioblate Surgical Ablation System using the modified Maze III procedure. The trial population includes patients requiring valve replacements or repairs, atrial septal defect (ASD) repairs, patent foramen ovale (PFO) closure or coronary artery bypass graft (CABG) procedures. The study objectives are to demonstrate that the Medtronic Cardioblate Surgical Ablation System can safely and effectively treat permanent AF patients.


Eligibility Criteria:
Inclusion Criteria:

1. Patients must have a documented history of permanent AF (cardioversion failure) as defined by the ACC/AHA/ESC Guidelines.
2. Concomitant indication (other than AF) for open-heart surgery for one or more of the following:

   * Mitral valve repair or replacement
   * Aortic valve repair or replacement
   * Tricuspid valve repair or replacement
   * Atrial septal defect (ASD) repair
   * Patent foramen ovale (PFO) closure
   * Coronary artery bypass procedures
3. Greater than or equal to 18 years of age
4. Able and willing to comply with study requirements by signing a consent form
5. Must be able to take the anticoagulant warfarin (Coumadin)

Exclusion Criteria:

1. Wolff-Parkinson-White syndrome
2. NYHA Class = IV
3. Left ventricular ejection fraction ≤ 30%
4. Need for emergent cardiac surgery (i.e. cardiogenic shock)
5. Previous ablation for atrial fibrillation, AV-nodal ablation, or surgical Maze procedure
6. Contraindication for anticoagulation therapy
7. Left atrial diameter \> 7.0 cm
8. Preoperative need for an intra-aortic balloon pump or intravenous inotropes
9. Renal failure requiring dialysis or hepatic failure
10. Life expectancy of less than one year
11. Pregnancy or desire to be pregnant within 12 months of the study treatment.
12. Current diagnosis of active systemic infection
13. Documented MI 6 weeks prior to study enrollment
Clinical Outcomes of CAD/CAM Single-Retainer Monolithic Zirconia Ceramic Resin-Bonded Fixed Dentures Bonded With Two Different Resin Cements

Congenitally missing tooth is one of the most common anomalies in human dentition. The treatment options of lateral incisor agenesis are closing the space with orthodontic treatment, implant treatment, conventional fixed dental prosthesis (FDPs) and resin-bonded fixed dentures (RBFDs). RBFDs are used frequently for single tooth absence in the anterior region due to their minimal invasive properties, high clinical success and patient satisfaction. With the development of new and stronger materials, RBFDs with metal framework have been replaced by glass ceramic, lithium disilicate, fiber-reinforced composite (FRC) and zirconia. The aim of this study is to evaluate the clinical performance of CAD/CAM single-retainer monolithic zirconia ceramic RBFDs which cemented with two different resin cements.

The aim of this study is to evaluate the clinical performance of CAD/CAM single-retainer monolithic zirconia ceramic RBFDs which cemented with two different resin cements.

The project includes 20 patients. Most of the patients have been recruited from the Istanbul Medipol University Dental Clinics in Istanbul. The patients were selected from individuals who have unilateral or bilateral congenitally missing maxillary lateral teeth and wanted to be treated a restoration or undergoing orthodontic treatment.

After giving their consent to take part in the study no preparations were made on abutment teeth for RBFDs. Digital impressions were taken with an intraoral digital scanner. The RBFDs were designed using a CAD software, milled and presintered zirconia blocks (KatanaTM Zirconia HT, Kuraray Noritake Dental Inc, Tokyo, Japan). RBFD was adhesively bonded to abutment teeth with one of the two different resin cements (Panavia F2.0 or Panavia V5).

The control procedure is:

The restoration is evaluated according to presence of mobility or debonding and fracture at the connector area. Gingival harmony and periodontal tissues around the restorations were also examined. Mobility of the abutment tooth was checked in the clinical examination and alveolar bone was examined with periapical x-ray. The controls will take place after two weeks, one year, two years, three years and five years.

Eligibility Criteria:
Inclusion Criteria:

* Participating in the study voluntarily
* Horizontal mobility of central incisors ≤1 mm
* Central incisors with healthy alveolar bone
* 1-1,5 mm overjet
* Having a good anterior guidance

Exclusion Criteria:

* Patients with gingivitis or periodontitis Poor oral hygiene Central incisors with endodontic treatment or periapical disease Central teeth with large fillings or loss of dental structure on the cementation surface Bad oral habits Patients with clinical symptoms of bruxism
Sleep Disturbance and Sleep Quality in Women With Fibromyalgia Syndrome

The purpose of this week long study is to describe sleep and problems with sleep in women diagnosed with Fibromyalgia syndrome.

At least 50 women over 18 years of age are invited to volunteer in this study. Sleep quality and problems with sleep will be described using several kinds of measures. Questionnaires on sleep and Fibromyalgia will be completed by the volunteer. In addition, the volunteer will complete a sleep diary for at least 7 days and wear an Actiwatch (a wrist watch like device that measures sleep). At completion of the study, participants will be provided a print out of their sleep obtained from the Actiwatch.

Participants may not be in the study if they work night shift (11 pm - 7 am) or have been diagnosed with a condition called sleep apnea.

Participants need not live in Kentucky to participate in this study.

Eligibility Criteria:
Inclusion Criteria:

* Women 18 years old; diagnosed with Fibromyalgia;

Exclusion Criteria:

* Volunteer works night shift (11PM - 7AM);
* Volunteer has been diagnosed with sleep apnea.
Study of the Absorption, Metabolism, and Excretion of [14C]-Ecopipam in Healthy Male Subjects

Phase 1, single-center (United Kingdom), open-label, nonrandomized, single-dose study in healthy adult male subjects to assess the absorption, metabolism, and excretion of \[14C\]-Ecopipam in Healthy Male Subjects.

This study will be a Phase 1, open-label, nonrandomized, single-dose study in healthy male subjects. Potential subjects will be screened to assess their eligibility to enter the study within 29 days prior to dose administration. Subjects will be admitted into the clinical research unit (CRU) on Day -1 and be confined to the CRU until at least Day 8 (Discharge). On Day 1, subjects will receive a single oral dose of 200 mg ecopipam HCl containing approximately 88.5 µCi of \[14C\]-ecopipam HCl. Subjects will be discharged when the following discharge criteria are met:

* plasma radioactivity levels below the limit of quantitation for 2 consecutive collections;
* ≥ 90% mass balance recovery; and
* ≤ 1% of the total radioactive dose is recovered in combined excreta (urine and feces) in 2 consecutive 24-hour periods in which collections occur. If discharge criteria are not met on Day 8, subjects will remain in the CRU and additional 24-hour collections (blood, urine, and feces) for total radioactivity will continue until these criteria are met, up to a maximum of Day 15.

Eligibility Criteria:
Inclusion Criteria:

* Males of any race between 35 and 55 years of age
* Body mass index between 18.0 and 30.0 kg/m2
* In good health
* Males will agree to use contraception
* Able to comprehend and sign an informed consent form
* History of a minimum of 1 bowel movement per day

Exclusion Criteria:

* History of significant medical illness
* History of clinically significant drug allergy
* History of a seizure disorder, not including infantile seizures
* History of stomach or intestinal surgery that would potentially alter absorption and/or excretion of orally administered drugs
* Clinically significant medical treatment within 8 weeks or infection treatment within 4 weeks of dosing
* Clinically significant ECG abnormality
* History of alcoholism or drug/chemical abuse within the previous 2 years or positive screening test
* Significant alcohol consumption
* Positive hepatitis panel and/or positive human immunodeficiency virus test
* Use of prohibited prescription, over-the-counter medications or natural health products
* Use of tobacco or nicotine-containing products within 3 months prior to Check-in or positive screening test
* Receipt of blood products within 2 months prior to Check in
* Recent donation of blood, plasma, or platelets prior to Screening
* Exposure to significant diagnostic, therapeutic or employment in a job requiring radiation exposure monitoring within 12 months prior to Check-in
* Evidence or history of active suicidal thoughts in the previous 5 years or have any lifetime history of a suicide attempt
* Not suitable for study in the opinion of the Principal Investigator
Involvement of Patients and Relatives in the Course of Cancer Disease

The objective is to investigate a rehabilitation program (supportive conversations and a rehabilitation course for cancer patients and their relatives together).

The study evaluate the effect of the program compared to no intervention (usual care)

The study aim to evaluate the effect and the benefit of the program.

First the patients psychosocial well-being is assessed in a survey (EORTC, POMS, WHO-5 well-being index) Then their relatives psychosocial well-being is assessed in a survey (Ad hoc questions, POMS and WHO-5 well-being index)

The effect is also assessed in qualitative interviews with patients and their relatives.

The rehabilitation course is investigated in qualitative observations and interviews.

Eligibility Criteria:
Inclusion Criteria:

* Both the patient and their relative must agree to participate together
* Patient admitted to the Hospital
* Patient admitted with a lung cancer diagnosis or
* Patient admitted with a gynecological cancer diagnosis

Exclusion Criteria:

* The cancer diagnosis was not verified.