cyrilzakka/clinical-trials huggingface dataset:
Intraoperative Versus Postoperative Thymoglobulin in Lung Transplantation

The purpose of this study is to take a population of lung transplant recipients who meet UCLA criteria for induction chemotherapy with thymoglobulin and prospectively study weather giving the first dose intraoperatively versus postoperatively makes a difference with how patients do during and after lung transplantation.

The purpose of this study is to take a population of lung transplant recipients who meet UCLA criteria for induction chemotherapy with thymoglobulin and prospectively study weather giving the first dose intraoperatively versus postoperatively makes a difference with how patients do during and after lung transplantation. In addition, these cohorts will be compared to patients who do not qualify for thymoglobulin and receive either an alternative agent or no agent. The primary endpoint is primary graft dysfunction. We will also evaluate several other early and late end points such as ventilator days, ICU/hospital days, acute/chronic rejection, infection, CT chest abnormalities, and survival.

We will also collect donor lung tissue and lavage fluid for measurement of various proteins and receptor expression at two time points: (1) prior to implementation and dosing of induction chemotherapy and (2) after transplantation (following a course of induction chemotherapy). This will allow us to possibly make a connection between the profiles of the various proteins and receptors and the clinical outcomes, depending on weather the patient has received induction chemotherapy, starting intraoperatively or postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* On a voluntary basis, all patients eligible for bilateral lung transplantation between the ages of 18-65 years (inclusive)

Exclusion Criteria:

* Have any known allergy to horse or rabbit antithymocyte polyclonal agents
* Have a preoperative platelet count less then 100,000/mm3
* Are recipients of multiple organ transplants (either simultaneous or sequential)
* Are recipients of a single lung transplantation
* Have a contraindication to rabbit antithymocyte globulin based on judgement of the investigators (i.e. bleeding diathesis or overwhelming risk of intense immunosuppression) including the following patients: greater than 65 years of age, prior diagnosis of malignancy (with the exception skin malignancies), underlying suppurative lung disease (i.e. bronchiectasis, cystic fibrosis, etc.).
Comparison of Insulin Detemir Produced by the Current Process and the NN729 Process in Healthy Subjects

This trial is conducted in Europe. The aim of this trial is to demonstrate bioequivalence between insulin detemir produced by the NN729 process and by the current process in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Considered generally healthy upon completion of medical history and physical examination as judged by the Investigator
* Body mass index (BMI) between 18.0 and 27.0 kg/m\^2, inclusive
* Non-smoker
* Fasting plasma glucose (FPG) maximum 6.0 mmol/L

Exclusion Criteria:

* Known or suspected allergy to trial products or related products
* Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures (intrauterine device (IUD) that has been in place for at least 3 months, sterilisation, the oral contraceptive pill (which should have been taken without difficulty for at least 3 months) or an approved hormonal implant)
* A history of alcohol or drug abuse
The Effect of Different Types of Plant-Based Fiber in a Protein-Containing Meal During Satiety and Hunger States

The study was carried out once a week on the same day and for three-week duration, with total of 17 randomly selected participants with ages between 18 and 24 years. The test foods containing different vegetable fiber sources (chickpeas and oats) were given to the participants every week as isocaloric, which have been the control food for a week. The satiety status was evaluated by visual analog scale (VAS) for total of five times as immediately before the test food consumption and at 30, 60, 90 and 120 minutes after consumption. Fasting and postprandial blood glucose levels were measured. A 24-hour retrospective food consumption record was obtained the next day.


Eligibility Criteria:
Inclusion Criteria:

* Age range of 18-24 years,
* Studying at the university,
* Not smoking,
* Having normal BMI according to the World Health Organization (18.5-24.9 kg / m2),
* Satisfy blood donation criteria,
* Along with not suffering from diabetes,
* Abnormal thyroid problem,
* Gastrointestinal disorder,
* Food allergy or intolerance

Exclusion Criteria:

* Individuals who smoke,
* Follow a special diet program,
* Having eating disorder,
* Vegan or vegetarian,
* Do not consume legumes,
* Having gluten or lactose intolerance,
* Suffering from a chronic disease,
* Pregnant or breastfeeding
Validation of the Stardust Cardio-Respiratory Recorder

Introduction: The full night polysomnography (PSG) in sleep lab is the gold standard to Obstructive Sleep Apnea (OSA) diagnosis. However, there is a need to evaluate simple and accurate home diagnostic equipment that can reliably detect or exclude OSA. The aim of our study was to evaluate if an ambulatory portable monitor (SD) is accurate to measure apnea-hypopnea index (AHI) in OSA patients referred to a Sleep Lab. Methods: Patients with clinical suspicion of OSA were selected. Three-order randomized evaluations had been performed within a period of two weeks: the 1) SD (Stardust®, Respironics, Inc, USA) was used at patients home (SD home), 2) SD was used simultaneously with PSG in the sleep lab (SD+PSG lab) and 3) PSG was performed without the use of SD (PSG lab). Four AHI were generated and analyzed: AHI from SD home, AHI from SD of SD+PSG lab, AHI from PSG of PSG+SD lab and AHI from PSG lab. The analyses of SDs and PSGs recordings were performed by two blinded technicians.


Eligibility Criteria:
Inclusion Criteria:

* Patient referred to Sleep Disorder Center because of:

  * Excessive daytime sleepiness,
  * Loud snoring,
  * Witnessed apnea.
* Patient with ability to provide consent, ability and willingness to follow study procedures.

Exclusion Criteria:

* Suspicion of insomnia,
* Restless leg syndrome,
* Periodic limb movements; or
* Other non-OSA sleep disorders.
* Patient experiencing acute illness, patients who are medically complex, and patients requiring supplemental oxygen or mechanical ventilation.
Effectiveness of Intranasal Versus Intravenous Fentanyl in Preterm and Term Newborns for Pain Prevention

Neonatal intensive care unit patients undergoes many painful procedures during their hospitalization. Effective pain control in such procedures as intubation, catheterization, central line insertion, chest tube insertion, etc. is an important part of treatment. Opioids administration is a common practice for acute pain prevention. Fentanyl is the preferred opioid due to it rapid onset and short duration of action.

Fentanyl may be given intravenously, transcutaneous transmucosal and intranasal. Intranasal administration is practiced for about 20 years. A rich vascular supply in a nose provides rapid absorption of the drug. This uninvasive root is now popular for pain prevention and treatment. There are about 20 trials with intranasal fentanyl administration to children from 6 month old to 18 years. The investigators did not find information about this way of administration in neonates.

In our pilot study the investigators want to check if intranasal administration of fentanyl is safe and effective in pain prevention in term and preterm neonates during invasive procedures and to compare it with intravenous route of administration.


Eligibility Criteria:
Inclusion Criteria:

Term and preterm neonates that require invasive procedures (elective or semielective intubation, central line insertion , chest drain or abdominal drain)

Exclusion Criteria:

1. Neonates with prolonged analgesic treatment before the procedure
2. Neonates with neurologic problem which can interact with pain assessment
An Open-Label Study Examining the Long-Term Safety of Exenatide Given Twice Daily to Patients With Type 2 Diabetes Mellitus

The aim of this study is to assess the long-term safety of exenatide in patients with type 2 diabetes who were treated with exenatide in Study H8O-MC-GWAA (6-month study) or Study H8O-MC-GWAD (12-month study). Study H8O-MC-GWAN serves as an open-ended extension to Studies H8O-MC-GWAA and H8O-MC-GWAD.


Eligibility Criteria:
Inclusion Criteria:

* Patients received exenatide therapy in Study H8O-MC-GWAA or Study H8O-MC-GWAD and completed the respective study.

Exclusion Criteria:

* Patients were excluded or discontinued early from Study H8O-MC-GWAA or Study H8O-MC-GWAD.
* Patients have received treatment within the last 30 days with a drug, not including exenatide, that has not received regulatory approval for any indication at the time of study entry.
Effect of Intensified Occupational Therapy on Basic Activities of Daily Living

The objective is to investigate the effect of an intensified occupational therapy intervention on independence in basic activities of daily living (ADL) in subjects with stroke


Eligibility Criteria:
Inclusion Criteria:

* First-time stroke
* \<=4 on four of six Functional Independence Measure (FIM) basic ADL items

Exclusion Criteria:

* Not able to understand danish
LapBand Adjustment to Improve Early Weight Loss

Subjects having a gastric band fitted will have the first band adjustment done at surgery. The stoma will be set to 7mm using the EndoFLIP system to measure stoma size. Thereafter, band adjustments will be made using an adjustment chart, created at surgery, which shows stoma size versus band fill, to make adjustments in the normal follow-up visits. It is hypothesized that an early adjustment at surgery will promote earlier weight loss, and result in fewer band adjustments being required in the first year after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing gastric band surgery
* Over 18 years of age

Exclusion Criteria:

* Actively bleeding varices
Viability of Pulsioflex Monitoring in ICU

Goal of the Study is to Study the precision of semi-invasive cardiac index monitoring by means of the ProAQT (PULSION Medical Systems SE) sensor, whereby the pulmonary artery catheter will serve as gold standard.

Goal of the Study is to Study the precision of semi-invasive cardiac index monitoring by means of the ProAQT (PULSION Medical Systems SE) sensor, whereby the pulmonary artery catheter will serve as gold standard.

Measurements will be performed contemporaly with both devices every 4 hours and all clinical and hemodynmaic parameters will be recorded, including but not limited to central venous pressure, wege pressure, mechanical ventilation pressures, blood pressures, volume balance as well as vasoaktive medikation doses. This precise evaluation shall serve to evaluate the precision of the ProAQT to estimate the cardiac index under different clinical situation in the intensive care unit. A precision difference of below 30% between both methods will be regarded as clinically irrelevant, suggesting equipoise between both methods.

Eligibility Criteria:
Inclusion Criteria:

* In situ pulmonary artery catheter
* Above 16 years of age
* At least 36 hours of continuous hemodynamic monitoring with the pulmonary artery catheter planed

Exclusion Criteria:

* Patients with:
* Permanent or pesisting Atrial Fibrilation or Ventricular Arrythmias
* Moderate to Severe Aortic Insuficiency or Aortic Stenosis
* Intravascular Cardiac Assist Device
* Planed removal of the pulmonary artery catheter \<36 hours
Study of Individualized Physiotherapy for Airway Clearance in Cystic Fibrosis.

The purpose of this study is to investigate individual efficacy in Physiotherapy for Airway Clearance, and to investigate user experience, i.e.utility value and preference.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis: CF
* Age \>18 years
* Amount of sputum \>5 ml/60 min
* Wet inhalation of saline/DNase/both
* Informed consent

Exclusion Criteria:

* Respiratory failure
* Hemoptysis
* Bacteriology (burkholderia cephacia, multi-resistent pseudomonas aeruginosa, atypical mycobacteria, MRSA).
* Ongoing intravenous medication
* Pregnancy
Study to Assess the Activity of Nexrutine® in Prostate Cancer Patients

The purpose of the study is to (1) to determine the rate of PSA decline (the number declining). Tissue will be obtained for ancillary studies and (2) to determine the number of patients with a PSA decline to \<1.0 ng/ml at 3 months in patients receiving Nexrutine® with standard radiation therapy. The Secondary Objective is to confirm the tolerability of this regimen. The Third Objective (Ancillary studies) is To evaluate the molecular response of Nexrutine®. Molecular response is defined as changes in the molecular pathways.


Eligibility Criteria:
Inclusion Criteria:

1. Have a histologic diagnosis of prostate cancer (in more than 1 core) with one of the following:

   * Gleason \> 6,
   * Unilateral Gleason 6 in ≥ 3 cores,
   * bilateral Gleason 6,
   * PSA \> 10.0 ng/ml.
2. Age ≥18 years.
3. Has an ECOG Performance Status 0-2 or Karnofsky 60-100.
4. Has the following laboratory values at study entry: absolute neutrophil count (ANC) ≥ 1,500 cells/μL; platelet count ≥ 100,000 cells/μL; hemoglobin ≥ 9 g/dL; total serum bilirubin ≤ 1.5 x institutional upper limit of normal (ULN); ALT and AST ≤ 1.5 x institutional ULN if alkaline phosphatase is ≤ULN creatinine and BUN ≤ 1.5 x institutional upper limit of normal (ULN)
5. Signed informed consent
6. No new, undiagnosed bone pain or has a negative bone scan. (within 2 months of consent) If there is no bone pain, then a bone scan is not required.

Exclusion Criteria:

1. Has documented metastatic disease.
2. Has received a prior chemotherapy or androgen ablation.
3. Has received prior immunotherapy.
4. Has been previously treated with Strontium, Samarium, other systemic radioisotopes or radiation therapy.
5. Has diagnosis of congestive heart failure
6. Currently taking anticoagulation medications, i.e., coumadin or heparin. Over the counter aspirin and ibuprofen are allowed.
7. Is receiving any other investigational agents for cancer.
8. Has a history of other malignancy within the last 5 years, which could affect the diagnosis or assessment of prostate cancer.
9. Has a serious intercurrent illness with a life expectancy of less than 5 years.
10. Has a concomitant medical, psychological, or social circumstance, which would interfere with compliance with the protocol treatment and follow-up.
11. Use of any herbal or alternative regimens, which may have antineoplastic or hormonal activity (including but not limited to finasteride, dutasteride, Saw Palmetto, PC-SPES, shark cartilage, etc), is prohibited while receiving study treatment.
12. Clinical stage T3 or T4 and PSA \>10 ng/ml and Gleason \> 8.
13. Patient is to receive adjuvant androgen ablation with the radiation.
14. EKG which shows a baseline QTc \> 450 msec or ischemic changes. For ischemic changes, patient will be eligible if evaluated and cleared by internal medicine.
15. Previous history of drug-induced QTc prolongation and/or concurrent treatment with medications that are known to produce or are suspected of QT prolongation.
Vasoactive Hormones and Oxygen Saturation During Apneic Events in Patients With Obstructive Sleep Apnea

The mechanisms involved in development and maintenance of hypertension in obstructive sleep apnea are not clarified.

We hypothesize that patients with obstructive sleep apnea have an abnormal level of some vasoactive hormones during apneic events during sleep.


Eligibility Criteria:
Patients with Obstructive sleep apnea

Inclusion Criteria:

* Severe obstructive sleep apnea (apnea-hypopnea index \> 30)

Exclusion Criteria:

* Drug or alcohol abuse
* Pregnancy
* History or clinical signs of disease in the heart, lungs, brain, liver, kidneys or endocrine organs
* Diabetes

Healthy Controls

Inclusion Criteria:

* Apnea-hypopnea index \< 10

Exclusion criteria:

* Drug or alcohol abuse
* Pregnancy
* History or clinical signs of disease in the heart, lungs, brain, liver, kidneys or endocrine organs
* Diabetes
Atrial Fibrillation Prevention in Post Coronary Artery Bypass Graft Surgery With Cryoablation for Ganglionic Plexi

Atrial fibrillation after coronary artery bypass graft is a common complication.

The investigators have thought that the mechanism of temporarily postoperative atrial fibrillation is closely related to the autonomic nervous system imbalance.

In a last several years, cryoablation was substituted for atrial incision in many reports to simplify the maze procedure.

However, there has been no comparative study to delineate the feasibility of the use of cryoablation.

Modified maze procedures that use energy sources for the ablation of atrial fibrillation concomitant with cardiac surgery have been shown to improve outcomes in patients with atrial fibrillation. Cryoablation of atrial fibrillation recently has been shown to lead to outcomes that were at least equivalent to those reported for other energy modalities over both short- and medium-term follow-up times.

Eligibility Criteria:
Inclusion Criteria:

* coronary artery graft bypass patient
* sinus rhythm

Exclusion Criteria:

* Patients using antiarrhythmic
* severe hypotension after surgery ( systolic blood pressure \<90mmHg)
* history of atrial fibrillation
Sensitivity Training for Parents With Premature Infants

This study evaluated the effectiveness of a culturally adapted version of the Mother-Infant Transaction Program (MITP) among Chinese mothers with premature infants in public hospitals in Hong Kong.

Potential participants at two public hospitals in Hong Kong were identified by ward nurses. Mother-infant dyads with infants born at 36 weeks or earlier were assessed for eligibility. Data collection was conducted after obtaining written consent from the mothers. Mother-infant dyads who met the inclusion criteria were randomly allocated to either the intervention or the treatment-as-usual control group. Each dyad was assessed at six time points, i.e., baseline, immediately after intervention/TAU, and when the infants were at the gestation-corrected ages of 3, 6, 9, and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Mothers with premature infants born at 36 weeks or earlier

Exclusion Criteria:

* insufficient spoken and written Chinese ability of the mother
* mother under 18 years of age
* triplets or higher multiples
* infants with congenital abnormalities (e.g., metabolic disorder, chromosomal disorder)
Quality of Life in Patients With Liver Cancer Treated With Image-Guided Therapy

RATIONALE: Gathering information about quality of life over time from patients with liver cancer treated with image-guided therapy may help the study of cancer in the future.

PURPOSE: This clinical trial is gathering information about quality of life over time from patients with liver cancer treated with image-guided therapy.

OBJECTIVES:

* Develop a data repository for clinical and health-related quality of life outcome measures in patients with hepatic malignancies treated with image-guided therapies.

OUTLINE: This is a pilot, prospective, longitudinal study.

Patients complete a standard questionnaire assessing health-related quality of life at baseline, during routine follow-up care after image-guided therapy, and then annually thereafter. Health and disease status and the development of other illnesses are assessed by medical record review.

PROJECTED ACCRUAL: Not specified

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Undergoing concurrent image-guided therapy for hepatic malignancies using any of the following imaging techniques:

  * X-ray
  * Ultrasound
  * MRI
  * CT scan
  * Nuclear medicine imaging

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Comparing the Impact of Mindful Interoceptive Mapping and Mindful Breathing on Pain and Opioid Use

This is a single site, two-arm, parallel group randomized clinical trial comparing the effect of two mindfulness-based interventions (Mindful Interoceptive Mapping vs. Mindfulness of the Breath) on opioid-treated chronic pain patients' pleasant/unpleasant sensation reports and opioid use.


Eligibility Criteria:
Inclusion Criteria:

* (1) men/women ≥18 years of age,
* (2) current chronic low back pain condition determined by physician assessment (e.g., ICD-10 codes M54.5, M54.4, M54.3),
* (3) reporting pain ≥3 on 0-10 scale with opioid medication, and
* (4) long-term opioid pharmacotherapy (\>3 months of use).

Exclusion Criteria:

* (1) formal mindfulness training (e.g., MBSR/MBRP),
* (2) current cancer diagnosis,
* (3) psychosis, suicidality, and moderate/severe substance use disorder in the past year as assessed with the MINI, and
* (4) unstable illness, as judged by a physician, that may interfere with treatment.
Follow-Up Study for Men Diagnosed With Prostate Cancer Through Participation in a Prostate Specific Antigen Screening Program

There is controversy concerning the preferred treatment for men with localized prostate cancer with regard to the relative effectiveness of different treatments in controlling the cancer and how different treatments affect the patient's quality of life. The purpose of this research is to describe the disease course of prostate cancer and to determine the effectiveness, potential complications, and quality of life after different treatments in men with prostate cancer detected via screening with prostate-specific antigen (PSA) and/or digital rectal examination


Eligibility Criteria:
Men with prostate cancer diagnosed through the PSA screening study