cyrilzakka/clinical-trials huggingface dataset:
Postoperative Pain and SIRS After Preoperative Analgesia With Clonidine or Levobupivacaine

The purpose of this study was to investigate hypothesis that preoperative administration of epidural clonidine will reduce postoperative pain and systemic inflammatory stress response better than epidural levobupivacaine.

Investigations showed that upregulation of prostaglandin E2 and interleukin-6 at central sites is an important component of surgery induced inflammatory response in patients. Postoperative period is associated with an increased production of cytokines, which augment pain sensitivity. With adequate perioperative pain control it is possible to control central and peripheral inflammatory response to surgery, and influence on patient outcomes. Use of analgetics before the pain stimulus (preventive analgesia) prevent development of neuroplastic changes in central nervous system, and reduces pain. Clonidine is an alpha2-adrenergic agonist with sedative, analgesic and hemodynamic properties. It inhibits transmission of nociceptive stimuli in the dorsal horn of the spinal cord, acting on the inhibitory descending pathways. According to recent experimental investigations clonidine lowers proinflammatory cytokine level, and prevents hypersensitization acting through adrenoreceptors alpha-2A.

Levobupivacaine is a long-acting local anesthetic, S-enantiomer of bupivacaine, with identical anesthetic potency. When administered intraperitoneally or by local infiltration of operation site, levobupivacaine produced analgesia and reduction of proinflammatory cytokines. Investigations of epidural and intrathecal levobupivacaine provide evidence for improved postoperative analgesia with reduced analgesic consumption. But, it remains unknown if that analgesia is sufficient enough to blockade inflammatory stress response during perioperative time.We want to investigate and compare analgesic and immunomodulation efficacy of this two frequently used analgesics.

Eligibility Criteria:
Inclusion Criteria:

* colorectal resection surgery patients
* preoperative risk of anesthesia and operation, ASA (American Society of Anesthesiologists) physical status I or II

Exclusion Criteria:

* diabetes mellitus
* renal insufficiency
* liver insufficiency
* autoimmune disease
* corticosteroid and immunosuppressive use
* operation time exceeding six hours
Auricular Acupressure for Hemodialysis Patients With Insomnia

Auricular acupressure therapy (AAT) has been applied in MHD patients with insomnia in recent years and yielded favorable results. However, the effect and safety of AAT for insomnia in MHD population still lacks high quality evidence. A randomized controlled clinical trial is planned to evaluate the effect and safety of AAT in MHD patients with insomnia.

Insomnia, a worldwide health problem, is much more frequently complained in maintenance hemodialysis (MHD) patients and impairs their quality of life and long term outcome. Hypnotic sedative agents are often reluctantly prescribed with doses mounting up. Patients are concerned about drug dependence and drug-related adverse effects. As a non-drug therapy, auricular acupressure therapy (AAT) is attractive to both patients and practitioners and is widely used to treat many conditions in China. The investigators had been applying AAT for MHD patients with insomnia in recent years and yielded favorable results. However, the effect and safety of AAT for insomnia in MHD population still lacks high quality evidence. Therefore, the investigators aimed to perform a randomized controlled clinical trial in MHD patients with insomnia to evaluate the effect and safety of AAT.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18\~75 years
* On regular dialysis ( 2 - 3 sessions weekly, 4 hours each session, total weekly dialysis hours ≥ 10 hours) for more than 3 months (but less than 10 years)
* Insomnia according to The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
* Global score of PSQI \> 7
* Informed consent.

Exclusion Criteria:

* Presence of co-morbidities including cancer, congestive heart failure, connective tissue disease and hematologic diseases;
* Inadequately dialyzed, indicating by urea clearance index (KT/V) \< 1.20;
* Presence of severe physical symptoms such as bone pain, itchy skin, sleep apnea and restless legs which are obviously causative for insomnia; and weary condition caused by severe anemia (hemoglobin\<60g/L) or malnutrition (serum albumin\<30g/L).
* Infections of external ears or malformed ears.
A Study of Monthly Intravenous C.E.R.A. (Mircera) in Hemodialysis Participants With Chronic Renal Anemia

This single arm study will assess the efficacy, safety and tolerability of once-monthly administration of intravenous methoxy polyethylene glycolepoetin beta (Mircera) for the maintenance of hemoglobin levels in hemodialysis participants with chronic renal anemia. Participants currently receiving intravenous epoetin alfa or beta or darbepoetin alfa will receive intravenous Mircera at a starting dose of 120, 200 or 360 micrograms/month (based on the erythropoietin stimulating agent \[ESA\] dose administered on week -1). Subsequent doses will be adjusted to maintain hemoglobin levels within the target range of 10 to12 gram per deciliter (g/dL). The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.


Eligibility Criteria:
Inclusion Criteria:

* Chronic renal anemia;
* Continuous intravenous maintenance erythropoietin stimulating agent (ESA) treatment during previous month;
* Regular long term hemodialysis therapy with the same mode of dialysis for \>=3 months.

Exclusion Criteria:

* Transfusion of red blood cells during previous 2 months;
* Significant acute or chronic bleeding, such as overt gastrointestinal bleeding;
* Active malignant disease (except non-melanoma skin cancer).
Combined Aerobic and Resistance Exercise Training in Metastatic Renal Cell Carcinoma

The trial studies the effects of personalized home-based aerobic and resistance exercises on quality of life, changes in physical activity levels, and the change in inflammatory myokines with the exercise intervention in Interleukin 6 (IL-6), C-reactive Protein (CRP), Leptin, Transforming growth factor beta (TGF-beta), and Interferon (INF) gamma.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of RCC
* Patients being treated with standard of Programmed cell death protein 1 (anti-PD-1) or anti-PD-L1 immune-checkpoint inhibitor-containing standard of care regimen including patients who are about to start treatment or have been on treatment for a maximum of 4 weeks prior to signing consent
* Metastatic Measurable disease, as defined by RECIST 1.1
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 with a life expectancy ≥ six months
* Physically able to enroll in the exercise program as determined by the treating medical oncologist and after review by Physical medicine and rehabilitation physicians at Johns Hopkins
* Adequate bone marrow reserve and organ function measured within 28 days prior to administration of study treatment with the following key parameters:
* Hematological:

  * Absolute neutrophil count ≥ 1.5 × 109/L
  * Platelets ≥ 100 × 109/L
  * Hemoglobin≥ 9.0 g/dL
* Renal:

  * Serum Creatinine ≤ 1.5 x the upper limit of normal (ULN) or Calculated Creatinine clearance ≥ 30mL/min
* Hepatic:

  * Total bilirubin ≤ 1.5 x ULN (Patients with known Gilbert disease who have serum bilirubin level ≤ 3 x ULN may be enrolled)
  * Serum Aspartate aminotransferase (AST) and serum Alanine aminotransferase (ALT) ≤ 2.5 x ULN (For patients with documented liver metastases AST and/or ALT ≤ 5 x ULN)

Exclusion Criteria:

* The presence of bone metastasis in the spine, pelvis, and lower limbs
* Currently physically active or moderately active as determined by Leisure Score Index of Godin Leisure-Time Exercise Questionnaire (GSLTPAQ)
* History of underlying cardiovascular, respiratory, musculoskeletal disease or joint problems that preclude moderate physical activity
* Known underlying uncontrolled brain metastatic lesions requires steroids therapy and/or radiotherapy
* Major surgery within four weeks prior to enrollment.
* Radiotherapy for RCC 28 days prior to week 1 day 1
Percutaneous Unilateral Biportal Endoscopy Versus Uniportal Endoscopy for Lumbar Spinal Stenosis: Study Protocol

A prospective study aimed to compare the efficacy and safety of Unilateral biportal endoscopic (UBE) technique and uniportal endoscopic (UE) technique for treating patients with lumbar spinal stenosis (LSS).


Eligibility Criteria:
Inclusion Criteria:

* Age range: 50-80 years
* Diagnosed with LSS of 1-2 response levels
* The predominant manifestation is neurogenic intermittent claudication, and conservative treatment has been ineffective for at least 3 months
* Degenerative lumbar spondylolisthesis of less than I degree or without spine instability
* Patients agree to participate in the study and are willing to complete the follow-up

Exclusion Criteria:

* Isthmic lumbar spondylolisthesis or degenerative lumbar spondylolisthesis of greater than I degree
* Instability at the response level
* Prior surgical history at the response level
* Scoliosis with Cobb angle \&amp;gt;20 degrees
* Other conditions affecting the lumbar spine (infection, tumor, fracture, neurological diseases, and others)
* Patients with medical disorders who are unable to tolerate surgery
Gamified WellWe-intervention to Promote the Health and Wellbeing of Families With Small Children

The study evaluates the effectiveness of the WellWe-intervention in promotion of parental self-efficacy for healthy behaviors and mindfulness in parenting from the perspective of families. Aim is also to evaluate the effectiveness of the WellWe-intervention in facilitation of family-centered approach of the health visit in Child health clinic perceived by the families and Public health nurses (PHN). Half of the participants will receive WellWe-intervention and half of the participants will receive usual care.

Families with pre-school aged children attend to regular health visits in Child health clinics on a yearly basis. During the health visits PHNs assess and promote the health and wellbeing of the whole family through health discussions.

In this study we aim to evaluate whether the addition of gamified method into the health discussion promotes healthy behaviors and mindfulness of the families and increases the family-centered approach of health visit compared to the traditional method.

WellWe-intervention includes the use of gamified WellWe app at home and during the health discussion in the Child health clinic. Usual care includes paper-based questionnaires filled by the parents and health discussion using these questionnaires in the Child health clinic.

Eligibility Criteria:
Inclusion Criteria:

* families: Finnish speaking families with 4-year old child and attend into health visit in Child health clinic during data collection period.
* PHNs: a permanent employee in Child health clinic or deputy employee working in Child health clinic during the data collection period.

Exclusion Criteria:

* families: Child is developmentally disabled to participate to the use of WellWe-app with parents.
* PHNs: Deputy employees working in Child health clinic only a short period of time or temporarily.
Antiphospholipid Syndrome Collaborative Registry (APSCORE)

Antiphospholipid Syndrome (APS) is an autoimmune disorder in which the body recognizes certain normal components of blood and/or cell membranes as foreign substances and produces antibodies against them. Patients with these antibodies may experience miscarriages and blood clotting disorders, including heart attacks and strokes. APS may occur in people with systemic lupus erythematosus and other autoimmune diseases, or in otherwise healthy individuals.

The Antiphospholipid Syndrome Collaborative Registry (APSCORE) is a national registry and tissue repository for patients with APS. This registry will collect clinical information and blood samples from people with APS.

Registry participants will have a blood sample drawn and will be interviewed about their medical histories. Participants will be asked to return for a follow-up visit after two years. Clinical, demographic, and laboratory data will be collected. Registry resources will be made available to researchers and medical practitioners to support a broad range of research on the causes, diagnosis, mechanisms, and treatment of APS.

The University of North Carolina at Chapel Hill is the coordinating center and an enrollment site for the registry. There are seven other enrollment sites: Ball Memorial Hospital, Muncie, IN; Duke University, Durham, NC; Hospital for Special Surgery, New York, NY; Johns Hopkins University, Baltimore, MD; Morehouse School of Medicine, Atlanta, GA; University of Texas Health Science Center, San Antonio, TX; and University of Utah Health Science Center, Salt Lake City, UT.

Eligibility Criteria:
Inclusion Criteria:

* Antiphospholipid antibodies with or without associated clinical manifestations
Intensive Communication for Chronically Critically Ill

This study was a trial of a formal system of family meetings to support family decision makers of chronically critically ill patients in the intensive care unit.

Formal family meetings have been recommended as a useful approach to assist in goal setting, facilitate decision making, and reduce use of ineffective resources in the ICU. We implemented an "intensive communication system" to test the effect of regular, structured formal family meetings on patient outcomes among long-stay ICU patients

The design was a pre-post, tandem assignment of patients (n=217) receiving usual care and communication, followed by enrollment of intervention patients (n=354), from 5 ICUs. The "intensive communication system" included: (1) family meeting within 5 days of ICU admission and weekly thereafter; (2) each meeting addressed medical update, values and preferences, goals of care; treatment plan, and milestones for judging effectiveness of treatment.

We measured differences between control and intervention patients in indicators of aggressiveness of care or timing of treatment limitation decisions (ICU mortality, LOS, duration of ventilation, treatment limitation orders, or use of tracheostomy or percutaneous gastrostomy). Difference in outcomes among patients who died or who had treatment limitation orders, comparing control and intervention groups, was also examined.

Eligibility Criteria:
Inclusion Criteria:

* cognitively impaired mechanical ventilation \>3 days not expected to be discharged before 5 days having a family decision maker

Exclusion Criteria:

* no family member hospice referral
Evaluation of Hepatic Function Using Gadoxetic Acid Enhanced MRI

Liver function is a key factor that can help predict the clinical outcome in patients with cirrhosis. Traditionally, liver function was measured using either indocyanine green (ICG) or other radionucleotides. Recently, gadoxetic acid has been reported to show liver function in several studies. There have been several approaches to measure liver function using gadoxetic acid, and hepatocyte fraction is one of the promising methods. Since gadoxetic acid enhanced liver MRI is clinically used world widely, it would be valuable if we can measure liver function using hepatocyte fraction.


Eligibility Criteria:
Inclusion Criteria:

* patients with chronic liver disease or liver cirrhosis
* clinically scheduled for gadoxetic acid enhanced liver MRI
* signed informed consent

Exclusion Criteria:

* under 18 years
* transarterial chemoembolization, radiation therapy for liver or bile duct within 2 weeks
* systemic chemotherapy within 6 weeks
* any contraindication for contrast enhanced MRI
* hepatic iron deposition at prior imaging
* bile duct obstruction
Total Knee Replacement Component Alignment Using Manual Versus Custom Instrumentation

1. To determine whether the low-dose, biplanar x-ray imaging (EOS) has the same accuracy as computed axial tomography (CT)
2. To validate low-dose, biplanar x-ray imaging (EOS) as a tool to evaluate 3-dimensional alignment of Total Knee Replacement implants.
3. To evaluate differences in total knee replacement implant alignment in patients whose arthroplasty is performed using manual or custom instrumentation derived from preoperative CT

Achieving optimal prosthetic alignment of the femoral, tibial and patellar components during Total Knee Replacement (TKR) is of great importance as it contributes to better function, less pain and improved quality of life.TKR requires accuracy in the execution of bone cuts in the correct orientation to the coronal, sagittal and axial planes. Malposition potentially leads to increased mechanical stress on the bearing surfaces and inevitably to earlier loosening.

Computed Axial Tomography (CT) is the gold standard technique to evaluate implant alignment in the coronal, sagittal and axial planes. As such, CT has imaging has been used to create custom instrumentation with purported likely improvement in surgical outcomes. Customized instrumentation created from a preoperative CT has been shown to be safe and effective, with no reported difference in patient outcomes and similar total knee arthroplasty component alignment. However, taking into consideration CT's high levels of radiation, cost expenses and its inability to obtain images of the limb in weight-bearing position, CT scan cannot be used routinely as a postoperative tool to evaluate TKR implant positioning.

The imaging system manufactured by EOS Imaging (formerly Biospace Med, Paris) is a biplanar, low-dose radiation, full body, high resolution, radiological imaging system allowing simultaneous acquisition in the coronal and sagittal planes and in standing position.EOS' main benefits are the considerable reduction in radiation dose (up to 1000 times less than for CT and ten times less than the plain radiography) by using a gaseous detector. George Charpak, the inventor, was awarded the Nobel Prize in 1992 for this work. Moreover, the EOS system can provide 3D images by using the appropriate software algorithms, thus providing a low-radiation alternative to CT.

Eligibility Criteria:
Inclusion Criteria:

* Radiographically confirmed diagnosis of osteoarthritis (OA)
* Failure of non-operative treatment for the diagnosis of symptomatic osteoarthritis
* Age greater than 18 years
* Desire to proceed with elective TKR
* Completion of informed consent and signature of written consent form

Exclusion Criteria:

* Ligamentous instability that may necessitate a constrained TKR implant
* Retained hardware in the distal femur or proximal tibia of the operative extremity
* Medical contraindication to undergo preoperative CT, or inability to tolerate preoperative CT
Amnion Chorion Membrane in Comparison to Subepithelial Connective Tissue Graft in Gingival Recession Coverage

The present randomized, controlled, parallel-grouped trial included twenty patients (aged 20 to 54 years) suffering from Miller's class I or II gingival recession. Patients were randomly assigned into two equal groups; control group; the coronally advanced flap with the subepithelial connective tissue graft (CAF+SCTG) or the test group; coronally advanced flap with amnion chorion allograft membrane (CAF+AC).

The participants were randomly assigned to receive coronally advanced flap (CAF) with amnion chorion membrane or CAF with subepithelial connective tissue graft using a simple randomization procedure with a 1:1 allocation ratio. A computer generated randomization list was drawn up by a faculty member who was not involved in the recruitment. Allocation concealment was achieved by sealed coded opaque envelopes that contained the treatment to be performed to the enrolled subjects based on the randomized numbers. Consequently, patients were allocated to either AC membrane (intervention) or SCTG (control) groups. The sealed envelope containing treatment assignment was opened at time of the surgery and the number was picked by another person other than the operator.

Eligibility Criteria:
Inclusion Criteria:

* Subjects aged between 18 - 60 years old.
* Subjects with facial gingival recession defects in anterior and premolar teeth classified as either class I or II defects according to Miller's classification.
* Subjects able to tolerate surgical periodontal procedures.
* Accepts the 6 months follow-up period.

Exclusion Criteria:

* Current and former smokers.
* Pregnant females.
* Subjects received any periodontal therapy for a minimum of 6 months prior to the study.
* Subjects taking drugs known to interfere with wound healing.
* Subjects with unacceptable oral hygiene with plaque index \>2.
* Teeth with non-carious cervical lesions, cervical caries and malalignment.
A Study to Evaluate Changes in Smokers Using Oral Tobacco-derived Nicotine Products.

The purpose of this study is to evaluate changes in exposure to selected harmful and potentially harmful constituents (HPHC) by measuring biomarkers in adult smokers who partially or completely switch from smoking cigarettes to oral tobacco-derived nicotine (OTDN) products compared to those who continue exclusive smoking cigarettes or stop using all tobacco products.

This is an open label, randomized, 6 parallel-group clinical study evaluating changes in exposure to selected HPHCs, subjective effects, and product use behavior in adult smokers relative to continued smoking who are randomly assigned to continue smoking, partially or completely switch to oral tobacco-derived nicotine products, or stop using any tobacco products for 7 days.

Eligibility Criteria:
Inclusion Criteria:

1. Voluntary consent to participate in this study documented on the signed informed consent form (ICF).
2. Healthy adult males and females 21 to 65 years of age, inclusive, at Screening
3. Smoking history of an average of at least 10 but no more than 30 factory manufactured combustible cigarettes daily for at least 1 year prior to Screening. Brief periods (i.e., up to 7 consecutive days) of non-smoking during the 3 months prior to Screening (e.g., due to illness or participation in a study where smoking was prohibited) will be permitted.
4. Positive urine cotinine (≥ 500 ng/mL) at Screening.
5. Willing to comply with the requirements of the study.
6. Willing to use all test products after product trial at Check in.
7. Willing and able to abstain from cigarettes from Day 1 through the End of the study.

Exclusion Criteria:

1. Use of any type of tobacco or nicotine containing products other than manufactured cigarettes (e.g., e vapor products, roll-your-own cigarettes, bidis, snuff, nicotine inhaler, pipe, cigar, chewing tobacco, nicotine patch, nicotine spray, nicotine lozenge, or nicotine gum) in the 7 days prior to Check in
2. Self-reported puffers (i.e., adult smokers who draw smoke from the cigarette into the mouth and throat but do not inhale).
3. Planning to quit smoking in the next 30 days (from Screening visit).
4. History or presence of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, urologic, existing respiratory diseases, immunologic, psychiatric, lymphatic, or cardiovascular disease, or any other condition that, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results.
5. Clinically significant abnormal findings on the vital signs, physical examination, medical history, ECG, or clinical laboratory results, in the opinion of the Investigator.