cyrilzakka/clinical-trials huggingface dataset:
Analgesic Effects of Perioperative Propranolol Administration for Spine Surgery

The purpose of this study is to determine if treatment with low-dose oral propranolol in the days before and after surgery decrease postoperative pain and improve pain scores.

This study is a randomized, double-blind, placebo controlled clinical trial.The main purpose of this study is to determine if postsurgical opioid use and pain scores are decreased with oral Propranolol treatment. The treatment period will last for six days and the observation period will last for three months. Effectiveness of treatment will be assessed by means of post-operative opioid consumption as primary outcome measure.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients age \>18 undergoing elective spinal fusion surgery, with plans to remain inpatient for ≥ 48hrs and receive IV or oral opioids;
* Females of child bearing potential must test negative on a pregnancy test at Visit 1 and utilize acceptable means of birth control for the duration of the study;
* Patients must be judged by the study team to be likely to be reliable and to agree to keep all appointments for clinic visits, tests, and procedures required by the protocol;
* Patients must have the ability to fully participate in the informed consent process.

Exclusion Criteria:

* Disease-related: History of exercise- or exertion-induced asthma or current treatments for asthma; Unstable medical or neurological illness; Heart block greater than first degree (EKG); History of coronary artery disease, or history of congestive heart failure; Baseline heart rate or blood pressure that in the opinion of the investigator would constitute too great a risk when considered in the context of the patient's medical comorbidities and health history; Significant suicidal or homicidal ideation, or current DSM-IV diagnosis of bipolar disorder, schizophrenia or other psychotic disorder, or cognitive disorder due to a general medical condition; History of diabetes
* Exposure-related: History of β-blocker use within six months of enrollment in the trial; Total baseline preoperative opioid consumption greater than 50 oral milligram morphine equivalents (MME) per day; Current use or use within the past two weeks of methadone, levorphanol, buprenorphine, butorphanol, pentazocine, tramadol, nalbuphine, naloxone, or naltrexone.
* Patient characteristics: Female patients who are pregnant or breast-feeding; Known allergy to study medication; Alcohol/substance abuse within past six months; Ongoing or anticipated disability compensation or litigation issues, in the best judgement of the investigator; Presence of any factors/conditions, medical or other, that in the judgment of the investigator may interfere with performance of study outcome measures, such as treatment-refractory history; Non-ambulatory or require the use of crutches or a walker; No access to a telephone
New Protein Biomarkers and Technology for Improving Diagnosis and Outcome Prediction in Mild TBI

Mild traumatic brain injury(mTBI) is a common cause of consultation to the emergency rooms worldwide and is the most common form of traumatic brain injury. Though classified as mild, as many as 40% of patients suffering mTBI do not make complete recoveries or present persistent symptoms. The present study is intended to determine long term outcome of patients suffering mTBI and to establish new prognostic models with the use of serum and saliva based biomarkers. For this purpose this study will not exclude patients regarding their comorbidities.


Eligibility Criteria:
Inclusion Criteria:

* Mild TBI (GCS 13-15 on admission)
* Blood sample obtained ≤24h after injury

Exclusion Criteria:

* GCS 3-12 on admission
* Time of injury unknown
* Time to injury exceeding 24 hours
* Primary admission for non-traumatic neurological disorder (e.g., stroke, spontaneous, intracranial hematoma)
* Penetrating head trauma
* Patient with mechanical ventilation from the trauma scene or prehospital management.
* Venipuncture not feasible
* Subject under judiciary control
Descriptive Analysis of Dual-energy Computed Tomography Exams of Adult Patients With Gout

The main objective is to describe urate deposits (especially in terms of distribution and volume) in soft tissues and bone, and joint erosions and destruction, in adult patients with gout.

Gout is the result of hyperuricemia, itself a consequence of a disorder of purine metabolism. This hypuricemia can lead to the deposition of sodium urate crystals in the soft tissues. It is the deposition of sodium urate crystals in and near the joints that causes an intense local inflammatory reaction with episodes of acute joint pain, swelling and functional disability. In the long term, uratic concretions in the soft tissues (tophus) occur, the joints are destroyed (uratic arthropathies), the kidneys also (gouty nephropathy).

Dual-energy CT (Computed Tomography) is a relatively recent technique that allows the identification of certain materials through the analysis of the difference in attenuation of the material exposed to two different X-ray spectra. This technique identifies the crystalline component of tophus.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 18 years old;
* Patient with a gout according to ACR (American College of Rheumatology) criteria;
* Affiliated with a social security scheme.
* Dual-energy scanner examinations stored in the PACS at Lariboisière Hospital

Exclusion Criteria:

* Pregnant or breastfeeding woman.
Transferability and Cost-effectiveness of PROSPECT in Surgical Trainees

To design, validate and prove cost-effectiveness of a comprehensive endovascular simulation curriculum consisting of cognitive and psychomotor skills training for endovascular management of symptomatic vascular disease in the lower limbs.

The main goal is to design a comprehensive endovascular simulation curriculum consisting of cognitive and psychomotor skills training for endovascular management of symptomatic vascular disease in the lower limbs (Rutherford classification 2-5; stenosis or occlusion in the iliac, superficial femoral and popliteal arteries). The curriculum will consist of E-learning, video-based learning and simulation exercises on the Virtual Reality simulator on which an endovascular procedure will be simulated.

Skills transferability to real life practice will be verified by means of a RCT. In this RCT the investigators will compare the cognitive knowledge and technical performance of curricular trained surgical trainees with conventionally trained trainees during treatment of patients under supervision. The hypothesis states that surgeons trained within the PROSPECT curriculum will show improved technical knowledge of endovascular treatment of atherosclerotic disease in the iliac, superficial femoral and popliteal arteries and will demonstrate increased technical proficiency in the angiosuite in comparison with surgeons who received only conventional training. Subjects will be surgical trainees (N=32). They will be randomized into a three groups: a control group (N=11), a group that only has access to E-learning (N=10) and a PROSPECT group (N=11). Both groups will continue their traditional clinical education and the PROSPECT group will additionally be trained within this endovascular curriculum. The investigators hope that this study may ultimately lead to an improvement in the quality of patient care by standardizing competencies of endovascular operators in training and practice.

Additionally a cost-effectiveness analysis of PROSPECT compared to traditional training modalities will be executed. A successful training program is expected to lead to a shortening of the learning curve, reduction in number of errors during real life procedures and more efficient use of hybrid angio suites. The financial impact of potentially shorter duration of endovascular interventions will be studied and compared to time investment and additional costs associated with stepwise, supervised training using VR simulators.

Eligibility Criteria:
Inclusion Criteria:

* Surgical trainee
* Knowledge and technical skill level evaluated
* Demographics questionnaire and general MCQ test completed
* 2 endovascular simulated exercises completed after familiarization with the simulator

Exclusion Criteria:

-
Ovarian Stimulation With FSH Alone Versus FSH Plus GnRH Antagonist in an Oocyte Donor/Recipient Programme

The aim of this study is to compare the efficacy of a protocol using FSH alone with that of a protocol using FSH plus a GnRH antagonist for controlled ovarian hyperstimulation in cycles of elective freezing in the context of a donor/recipient programme.

The hypothesis to be tested is that an ovarian stimulation protocol that includes FSH alone without any LH surge prevention regimens is not inferior to a protocol including FSH plus a GnRH antagonist in terms of clinical outcome in a donor/recipient model.

The formal sample size is calculated as follows:

If there is a true difference in favour of the experimental treatment of 5% (20% vs 15%), then 160 patients (80 per group in case of 1:1 enrolment) are required to be 80% sure that the upper limit of a one-sided 95% confidence interval (or equivalently a 90% two-sided confidence interval) will exclude a difference in favour of the standard/control group of more than 10%.

In the context of the present pilot study (as a first stage), the investigators intend to study 50 patients (25 per group in case of 1:1 enrolment). At a second stage the above mentioned sample size will be used.

Eligibility Criteria:
Inclusion Criteria:

* healthy women 21-32 years old with a BMI of 21 to 29 kg/m2 who wish to donate their oocytes
* normal ovarian reserve tests
* normal menstrual cycles of 26-32 days
* the women would not have received any hormonal treatment during the last three months before entering the study.

  * absence of coagulation and/or autoimmune disorders.

Exclusion Criteria:

1. Use of other protocols towards oocyte retrieval, such as natural, or modified natural cycles
2. Poor ovarian response according to the Bologna criteria \[22\],
3. History of endocrine or metabolic disorders, ovarian cystectomy or oophorectomy,
4. Women with the diagnosis of polycystic ovary syndrome
5. Clinical and/or laboratory markers of hereditary or acquired thrombophilia that complied to the standard protocols of each Unit.

   * Non-hormonal medication for a serious medical condition
Ultrabrief Pulsewidth Electroconvulsive Therapy (ECT)

Electroconvulsive Therapy (ECT) remains essential to contemporary psychiatric practice and is one of the safest and most effective treatments available for depression. Despite modern advances in pharmacotherapy, about 15-20 per cent of all hospitalised patients receive treatment with ECT. Its use, however, is limited by concerns over associated cognitive side effects.

Recent research has suggested that using an ultrabrief pulsewidth with ECT may greatly reduce cognitive side effects, while maintaining efficacy (Sackeim et al 2008). Preliminary results were positive for unilateral ECT, however, suggest that for bilateral ECT, dosing may need to be adjusted to preserve efficacy while reducing side effects. This study will examine the relative cognitive side effects and efficacy of right unilateral and bilateral ECT given with a standard pulsewidth or an ultrabrief pulsewidth. Some participants will also receive an MRI scan before and after ECT.


Eligibility Criteria:
Inclusion Criteria:

* Subjects meet criteria for a DSM-IV-TR Major Depressive Episode
* Total MADRS score \>/= 25
* Age \>/= 18 years
* Educated or working in an English medium setting

Exclusion Criteria:

* Diagnosis (as defined by DSM-IV-TR) of any psychotic disorder (lifetime with exception of Major Depressive Episode with psychotic features); rapid cycling bipolar disorder, eating disorder (current or within the past year); obsessive compulsive disorder (lifetime); post-traumatic stress disorder (current or within the past year).
* history of drug or alcohol abuse or dependence (as per DSM-IV-TR) in the last 6 months (except nicotine and caffeine).
* ECT in last 3 months
* Subject requires an urgent clinical response due to inanition, psychosis or high suicide risk
* unable to give informed consent
* score \< 24 on Mini Mental State Examination
Improve Sudden Cardiac Arrest Study

The purpose of this study is to demonstrate that primary prevention patients with one or more additional risk factors (1.5 prevention criteria: syncope/pre-syncope, non-sustained ventricular tachycardia (NSVT), frequent pre-ventricular contractions (PVCs), and low left ventricular ejection fraction (LVEF)) are at a similar risk of life-threatening ventricular arrhythmias (LTVA) when compared to secondary prevention patients, and would receive similar benefit from an implantable cardioverter defibrillator (ICD), or cardiac resynchronization therapy- defibrillator (CRT-D) implant.

Devices allowed in the study include any Medtronic single, dual, or triple chamber defibrillator that has received appropriate license or regulatory approval and is commercially available by Medtronic in the geography in which the implant will take place. Any market-released, commercially available lead(s) can be used in the study.

Eligibility Criteria:
Inclusion Criteria:

* Subject has a Class I indication for implantation of an ICD according to the American College of Cardiology (ACC)/American Heart Association(AHA)/Heart Rhythm Society (HRS) or European Society of Cardiology (ESC) Guidelines
* Subject (or subject's legally authorized representative) is willing and able to sign and date the Patient Informed Consent Form.

Exclusion Criteria:

* Subject is ≤ 18 years of age
* Subject with any exclusion criteria as required by local law (e.g., age, pregnancy, breast feeding)
* Subject is enrolled in a concurrent study that has not been approved for concurrent enrollment by the Medtronic Clinical Trial Leader
* Subject has any contraindication for ICD/CRT-D
Open Abdomen: Vacuum Pack Versus Sylo Bag and Mesh Protocol

The open abdomen is a valid and accepted surgical tactic for the trauma and acute care patient. There have been many mechanisms described for its management, but the most accepted strategy is the vacuum pack. At our hospital the investigators have used for many years a double sylo bag, one underneath the fascia and the other sutured to the skin, at the initial operation. At subsequent surgeries once the abdomen is clean the investigators leave the same subfascial sylo bag and use a prolene mesh attached to the fascia. Every day the investigators try to tighten the mesh with sutures until the abdomen can be closed. This study´s objective is to compare our double sylo bag- mesh protocol with the vacuum pack to determine which is related to a higher fascial closure rate.

The Investigators plan to compare our double sylo-mesh protocol with the vacuum pack technique described by Barker et al. To accomplish this they have designed a randomized trial that will include patients that require an open abdomen strategy according to their attending physician either due to a traumatic or a medical cause. Once the surgeon decides to leave the abdomen open, one of the nurses will pick up an envelope from the randomization box and read out loud the patients allocation (Vacuum pack or Double sylo bag-mesh protocol) . During subsequent surgeries the patient must continue with the same strategy for a minimum of 21 days or until fascial closure. The patients will be followed during their whole hospital stay to determine complication rates and fascial closures.

Eligibility Criteria:
Inclusion Criteria:

* Open Abdomen

Exclusion Criteria:

* Patients that die in the first 48 hours after the initial intervention
The Effect of Multiple Doses of BI 187004 on the Single-dose Pharmacokinetics of Repaglinide and Bupropion in Healthy Male Volunteers

To assess the influence of BI 187004 on pharmacokinetics of CYP2C8 and CYP2B6 probe drugs repaglinide and bupropion as a means of predicting drug-drug interactions.


Eligibility Criteria:
Inclusion criteria:

1. Healthy male subjects according to the investigator's assessment, based on a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests
2. Age of 18 to 55 years (incl.)
3. Body mass index (BMI) of 18.5 to 29.9 kg/m2 (incl.)
4. Signed and dated written informed consent prior to admission to the study in accordance with GCP and local legislation

Exclusion criteria:

1. Any finding in the medical examination (including BP, PR or ECG) is deviating from normal and judged as clinically relevant by the investigator
2. 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 50 to 90 bpm
3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
4. Any evidence of a concomitant disease judged as clinically relevant by the investigator
5. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
6. Cholecystectomy and/or surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except appendectomy and simple hernia repair)
7. 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 may apply.
Metabolic Pattern of Cyclosporine A and Acute Renal Failure

Following heart transplantation many patients develop acute renal failure in the early posttransplant phase and some are in need of renal replacement therapy for shorter or longer time. The cause of this acute renal failure is most probably multi factorial but many reports indicate that cyclosporine has a central role in the pathophysiology and it is generally recommended to lower the cyclosporine load to patients developing acute renal failure in this population.

Several in vitro studies on renal cells in culture indicate that the primary metabolites of cyclosporine (AM1, AM9, AM4N) are less toxic to the kidney than cyclosporine itself. However, the secondary metabolite AM19 as well as the cyclic metabolites AM1c and AM1c9 has been associated with decreased renal function and nephrotoxicity renal transplant recipients.

The primary objective of this pilot study is to investigate if the concentrations of secondary- and cyclic metabolites of cyclosporine (AM19, AM1c, AM1c9) is related to development of acute renal failure in the early posttransplant phase following heart transplantation.

Secondary objectives are to investigate associations between genotypes of P-glycoprotein and CYP3A5 and the metabolic pattern of cyclosporine.


Eligibility Criteria:
Inclusion Criteria:

* Heart transplant recipients receiving CsA as part of their immunosuppressive therapy.
* 18 years of age or older.
* Signed informed consent.

Exclusion Criteria:

* None
The Role of Pre-deployment Retraction in Decreasing Biopsy Clip Migration During Stereotactic Breast Biopsies

This will be a single-center prospective randomized control trial that is Institutional Review Board (IRB) approved. The study plans to enroll 250 female patients presenting to the University of Alabama at Birmingham (UAB) for stereotactic biopsy. This study is a prospective and will target approximately 250 patients. This will be a HIPPA-compliant randomized control trial planned on spanning approximately six months' time. Patients will be entered into the study only based on their already scheduled stereotactic biopsy procedure. Patients will be informed of the study and they will be offered the opportunity to participate or not participate in the study. Their participation is completely voluntary. This study will not involve any intervention that is not already a part of standard care. Patients will be randomized to two groups, one group that will undergo clip placement with approximately with a 5 mm retraction of the biopsy clip post-placement and one that will involve no retraction prior to deployment.


Eligibility Criteria:
Inclusion Criteria:

- Females 18-99 of age with recommendation for stereotactic biopsy.

Exclusion Criteria:

* Non-female patients
* Patients \< 18 years old
* Women who are pregnant
Rapid On-site Cytopathologic Evaluation in the Diagnosis of Hilar/Mediastinal Adenopathy

The purpose of this study is to determine whether rapid on-site cytopathologic evaluation (ROSE) can increase the diagnostic yield of transbronchial needle aspiration (TBNA) in the diagnosis of hilar and mediastinal lymphadenopathy.


Eligibility Criteria:
Inclusion Criteria:

* 18 years old and older
* Hilar and/or mediastinal lymphadenopathy (\> 1 cm on the short axis, as assessed by contrast-enhanced CT scan (computed tomography))

Exclusion Criteria:

* Uncontrolled coagulopathy
* Refusal to sign informed consent
Randomized Controlled Trial Targeting Obesity-related Behaviors

The intervention included biweekly access to group fitness classes, with (Group 1) or without (Group 2) weekly nutrition and physical activity education sessions. Outcome measures were assessed at baseline and immediately post intervention and included BMI, waist circumference, blood pressure, physical activity and dietary behaviors, and psychosocial variables.

This 15-week randomized controlled pilot study consisted of two groups. All participants received access to two group fitness classes per week, which were offered free of charge at the Caswell County Parks and Recreation Building. Zumba classes were offered one night a week, and the other evening was a 'potluck night' designed to increase participants exposure to a variety of other fitness classes such as floor aerobics, kickboxing, line dancing, and African dancing. Participants in the intervention group (Group 1) were enrolled in Eat Smart, Move More, Weigh Less (ESMMWL) where they received on hour weekly education classes on healthy eating and physical activity. The ESMMWL curriculum is a 15-week weight-management program that is delivered by local educators. Published research data were used to identify strategies that would lead to weight loss and/or weight maintenance. The program uses the Theory of Planned Behavior, and as such informs, empowers, and motivates participants to live mindfully as they make choices about eating and physical activity. The program provides opportunities for participants to keep a journal of healthy eating and physical activity behaviors.

Eligibility Criteria:
Inclusion Criteria:

* \>18 years of age,
* English-speaking,
* No self-reported contraindications to exercise
* Eligible participants where scheduled an enrollment appointment. At this appointment, participants with blood pressure over 180/110 were directed to obtain immediate medical attention and were only eligible to enroll upon written consent from their physician

Exclusion Criteria:

* \<18 years of age
* Non-English-speaking
* Self-reported contraindications to exercise
* Blood pressure over 180/110 without medical clearance