cyrilzakka/clinical-trials huggingface dataset:
Hemodynamic Effect of Lumbosacral Plexus Blockade Versus Spinal Anesthesia

The study evaluates the hemodynamic effect of lumbosacral plexus blockades versus spinal anesthesia for hip replacement. Half of participants will receive lumbosacral plexus blockade and the other half will receive continuous spinal anesthesia.

Patients for total hip replacement will be randomized for surgical anesthesia with either lumbosacral plexus blockade or continuous spinal anesthesia. All patients will receive central venous, arterial and spinal catheters. Hemodynamics will be monitored with transpulmonary thermodilution and pulse contour analysis. Perineural injection of study medicine around the lumbar and sacral plexus will be performed guided by ultrasound and nerve stimulation. Study medicine will be injected in divided doses in the spinal catheter. Treatment will be blinded using double-dummy technique. After the first intrathecal dose of study medicine, the hemodynamic response will be monitored for 60 minutes. Patients will then be transferred to the operating room, where total hip replacement will be performed in lumbosacral plexus blockade or spinal anesthesia according to randomization.

Eligibility Criteria:
Inclusion Criteria:

* Patients for total hip replacement at Aarhus University Hospital
* Age \>= 50 years
* American Society of Anesthesiologists physical status classification score I-III
* Informed consent

Exclusion Criteria:

* Lack of ability to cooperate
* Lack of ability to speak Danish
* Chronic pain, that demands opioid treatment. Not inkl. hip pain.
* Previous venous thromboembolic event
* Previous major back surgery
* Severe cardiopulmonary disease (NYHA class 4)
* Severe untreated hypertension (systolic blood pressure \> 160 mm Hg or diastolic blood pressure \> 110 mm Hg)
* Obesity (BMI \> 35 kg/m\^2)
* Pregnancy
* Allergy towards the used local analgetics
* Current treatment with amiodarone or verapamil
Evaluating the Efficacy of Lateral Heel Wedges of Osteoarthritis of the Knee

This study is looking at the efficacy of a sloped insole in patients with knee osteoarthritis. Regularly wearing a sloped insole over the course of one year will result in a wider joint space by x-ray in 60% of the subjects, a significant decrease in knee pain, decreased use of over the counter analgesics, and a clinically important improvement in the Womac pain and stiffness scale.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients 30 years or older with medial compartment knee Osteoarthritis (unilateral) and Grade 4 Kellgren-Lawrence39 radiographic changes presenting for treatment of knee pain.
* Range of motion knee-flexion beyond 100 degrees and not lacking more than 15 degrees of extension.
* Subtalar and forefoot motion permitting foot/ankle eversion with weight bearing.
* Sufficient shoe toe box height to allow space for the insole and therefore comfort and compliance.
* Passive laxity of medial capsule and collateral ligament by knee extension test.

Exclusion Criteria:

* All other forms of knee arthritis other than OA.
* Knee Instability- medial pseudo-opening of greater than grade 1 or detectable Anterior-posterior instability.
* Less than Grade 4 Kellgren-Lawrence radiographic changes in the medial compartment of the knee39.
* Grade 2 or greater Kellgren-Lawrence radiographic39 involvement of the patellofemoral or lateral compartment.
* Inadequate knee range of motion
* Balance problems requiring the use of a walker or wheel chair - ambulation with aid
* Diabetics with peripheral neuropathy
* Knee surgery within the past year
* Intraarticular steroid injection or visco supplementation within 6 months
* Stiff subtalar or forefoot joints - clinical test
* Inadequate shoe toe box depth to accommodate the test or control inserts
* Charcot joint
* Fixed contracture of the medial capsule and/or collateral ligament- clinical test
Efficacy of Polymyxin B Hemoperfusion on Severe Sepsis Secondary to Pneumonia or Urinary Tract Infection

Toraymyxin is an extracorporeal hemoperfusion cartridge containing Polymyxin B-immobilized fiber column designed to reduce blood endotoxin levels in sepsis. Meta-analysis of randomized trials showed that polymyxin B hemoperfusion significantly reduced the mortality of severe sepsis; however, the evidence was mainly contributed by the studies of abdominal sepsis. The data about using polymyxin B hemoperfusion to treat non-abdominal sepsis remain very limited. Investigators designed a clinical trial to evaluate the efficacy of polymyxin B hemoperfusion on treating non-abdominal severe sepsis. The study hypothesis is that removal of endotoxin by polymyxin B hemoperfusion in patients with pneumonia or urinary tract infection (UTI)-related severe sepsis will attenuate sepsis associated microcirculation failure and result in early reversal of shock and less extent of end-organ damage.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with septic shock defined by the third international consensus definitions for sepsis and septic shock
2. Newly diagnosed pneumonia or urinary tract infection (UTI) defined as the following:

   2-1. Pneumonia is defined by a new infiltrate on chest radiograph and the presence of one or several of the following signs or symptoms: cough, sputum production, dyspnea, core body temperature ≥ 38.0°C, auscultatory findings of abnormal breath sounds and rales and leukocyte count \> 10000 or \< 4000/L.

   2-2. UTI is defined by at least one clinical symptom (core body temperature ≥38.0°C, urinary urgency, polyuria, dysuria, suprapubic pain, flank pain, costovertebral angle tenderness, nausea and vomiting) and one urinary criterion (pyuria \>20 leukocytes/μL).
3. Hyperlactatemia (\>2 mmol/L)
4. Endotoxin activity assay (EAA) ≥ 0.5 units.

Exclusion Criteria:

1. Shock persisted \>12 hours before screening
2. Mechanical ventilation \>21 days
3. Uncontrolled hemorrhage
4. Thrombocytopenia (platelet count \< 30,000 cells/mm3)
5. Leukopenia (leukocyte count \< 1500 cells/mm3)
6. Suspected allergy to polymyxin
7. Females with pregnancy
8. Terminal cancer or organ failure with life expectancy less than 30 days
Natalizumab in Combination With Glatiramer Acetate (GA) in Patients With Relapsing-Remitting Multiple Sclerosis

The purpose of this study is to determine if natalizumab in combination with Glatiramer Acetate (GA) is safe and effective in delaying progression of individuals diagnosed with relapsing-remitting Multiple Sclerosis (MS).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of MS as defined by McDonald et al., criteria # 1-4
* Between the ages of 18 and 55, inclusive
* Baseline EDSS score between 0.0 and 5.0, inclusive
* Have been treated with GA for at least the 12 months prior to randomization

Exclusion Criteria:

* Primary progressive, secondary progressive or progressive relapsing MS
* MS relapse has occurred within the 50 days prior to randomization
* A clinically significant infectious illness
* History of, or abnormal lab result indicative of significant disease that would preclude the administration of a recombinant humanized antibody immunomodulating agent or GA for 20 weeks.
The Influence of Citric Acid Bone Surface Etching and Bone Defect Fill on GCF BMP-2 Release Profile

This study evaluates the effect of citric acid on bone surface of infrabony defects when used for 30 seconds at ph 1 and 50% concentration before the application of bovine derived xenograft to fill the defect, Bone Morphogenic protein 2 (BMP-2) marker was evaluated in 5 different days during the first month after surgery and clinical and radiographic parameters were reassessed after 6 months

Citric acid have been widely used to treat root surfaces of periodontally affected teeth in order to render it biologically suitable for fibroblast reattachment. however, systematic reviews showed no clinical significance when it was used as a root surface conditioner. Recently it was found in experimental studies that when citric acid was used on bone surface for a brief period, it increased bone formation and improved consolidation of grafted bone to bone bed. In this study infrabony defects were treated with citric acid PH 1 and 50% concentration for 30 seconds before washing it off and then application of bovine derived xenograft was done to fill the defect. BMP-2 marker was evaluated at days 1,3,7,14 and 30 by taking a sample using perio-paper from the gingival crevicular fluid (GCF) and clinical and radiographic parameters were taken after 6 months of follow-up

Eligibility Criteria:
Inclusion Criteria:

* Both genders aged between 32-60 years.
* Selected patient with a single site of:

  1. Two walled or three walled infra-bony defect.
  2. The bone defect should be at least 3 mm in depth from the crest of the alveolar bone to the base of the defect.
  3. Pocket depth of more than or equal to 5 mm.
  4. Clinical attachment loss equal or more than 3mm
* Patients ready to comply with oral hygiene measures.

Exclusion Criteria:

* Any systemic disease that contra-indicates periodontal surgery or may affect healing.
* Smokers
* Pregnant females
* Drug abusers
THE OMEGA-SPM-DOSE and OMEGA-SPM-PAD: Specialized Pro-Resolving Mediators in Patients With Peripheral Artery Disease

The purpose of this study is to understand the effects of fish oil supplement (containing parts of omega-3 fatty acids) on inflammation. The investigators are aiming to identify which dose of the fish oil supplement is the most effective. The name of the fish oil supplement is "SPM Emulsion."

The OMEGA-SPM-DOSE trial and the OMEGA-SPM-PAD trial are two parts of a pilot study which aims to investigate the effect of a novel formulation of a nutritional supplement containing highly concentrated n-3 PUFA metabolites (SPM Emulsion) on the metabolo-lipidomic profile of healthy volunteers and patients with Peripheral Arterial Disease(PAD). Ten healthy volunteers and ten patients with PAD will participate in Part 1a, the "OMEGA-SPM-DOSE Study". A follow-up, placebo controlled, prospective study on the best dosing modality determined in Phase 1a will then take place in a PAD and OA population (n=12), Phase 1b - the "OMEGA-SPM-PAD Study". Specific measurements will include targeted metabolo-lipidomic profiling, established markers of inflammation, and functional monocyte and macrophage assays. The proposed studies have the potential to provide important new insights on the role of nutritional interventions in PAD.

Eligibility Criteria:
Inclusion Criteria:

Healthy Volunteers:

-Age 20-80

PAD Patients:

* Mild claudication to rest pain (Rutherford 1-4)
* Resting or exercise ABI \< 0.9 or TBI \< 0.6
* Age 40 and more

OA Patients:

-Lower extremity (hip or knee) OA

Exclusion Criteria:

PAD, OA Patients and Healthy Volunteers:

* Plan to undergo surgical procedure or PVI for treatment of PAD within one month
* Evidence of active infection
* Hypersensitivity or allergy to fish or seafood
* Already on n-3 PUFA or equivalent
* Chronic liver disease, end-stage renal disease (CKD 5), or chronic inflammatory disorders
* Poorly controlled diabetes (HbA1C \> 8%)
* BMI \< 20 or \>35
* Recent other major surgery or illness within 30 days
* Use of immunosuppressive medications or steroids
* History of organ transplantation
* Pregnancy, or plans to become pregnant, or lactating

Healthy Volunteers:

* hsCRP \> 2mg/L
* Regular aspirin use
* Regular non-steroidal anti-inflammatory drug use
Coregistration of 18F-FDG-PET and MRI in the Staging of Potentially Resectable Hilar Cholangiocarcinoma: a Pilot Study

To evaluate the feasibility and performance of coregistered 18F-FDG-PET/MRI in the staging of potentially respectable hilar cholangiocarcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Hilar cholangiocarcinoma assessed by conventional imaging modalities (triphasic CT scan of the liver) and thought to be potentially resectable.

Exclusion Criteria:

* Biliary drain inserted.
* Contraindication for MRI.
* Pregnant or breast-feeding.
* Uncontrolled diabetes (over 9.7 mmol/L).
A Study to Determine the Safety and Efficacy of Autologous Human Platelet Lysate for Treatment of Androgenetic Alopecia

This is a multicentre, open label, randomized, pilot study to evaluate safety and efficacy of Human Platelet Lysate (HPL) in subjects with Androgenetic Alopecia. The study is being conducted at 2 centers in India. The primary endpoints are Improvement in Caliber \& Density of hair and Improvement in Photographic assessment from randomization to end of study. The secondary endpoints are Physicians and Patients self assessment score.


Eligibility Criteria:
Inclusion Criteria:

* Male subjects, aged between 18 to 50 years (both inclusive) and in general good health
* Subjects willing to refrain from other AGA treatments during the entire study duration
* Subjects who are willing to give informed consent and adhere to the study protocol.

Exclusion Criteria:

* Subjects aged \<18 or \> 50 years
* Subjects with dermatological disorder of scalp that might interfere with study evaluation
* Subjects on Anti-coagulant therapy
* Subjects with clinically significant medical or psychiatric disease as determined by the investigator.
* Subjects with dermatological disorder of scalp that might interfere with study evaluation
* Subjects unwilling to or unable to comply with the study protocol.
Avelumab in First-line NSCLC (JAVELIN Lung 100)

The purpose of this study was to demonstrate superiority with regard to Overall Survival (OS) or Progression Free Survival (PFS) of avelumab versus platinum-based doublet, based on an Independent Review Committee assessment, in Non-small cell lung cancer (NSCLC) participants with Programmed death ligand 1+ (PD-L1+) tumors.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects aged greater than or equal to (\>=) 18 years
* With Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1 at trial entry
* At least 1 measurable tumor lesion
* With histologically confirmed metastatic or recurrent (Stage IV) non-small cell lung cancer (NSCLC)
* With availability of a recently-obtained, formalin-fixed, paraffin-embedded (FFPE) tissue sample containing tumor (biopsy from a non-irradiated area preferably within 6 months) or a minimum number of 10 (preferably 25) unstained tumor slides cut within 1 week, and suitable for PD-L1 expression assessment
* Subjects must not have received any treatment for systemic lung cancer, and have an estimated life expectancy of more than 12 weeks
* Other protocol defined criteria could apply

Exclusion Criteria:

* Subjects whose disease harbors a EGFR mutation, or anaplastic lymphoma kinase (ALK) rearrangement are not eligible.
* Other exclusion criteria include prior therapy with any antibody or drug targeting T cell coregulatory proteins, concurrent anticancer treatment, or immunosuppressive agents
* Known severe hypersensitivity reactions to monoclonal antibodies (Grade \>= 3 NCI CTCAE v 4.03), history of anaphylaxis, or uncontrolled asthma (that is, 3 or more features of partially controlled asthma), and persisting toxicity related to prior therapy of Grade \> 1 NCI-CTCAE v 4.03.
* Subjects with brain metastases are excluded, except those meeting the following criteria: brain metastases that have been treated locally and are clinically stable for at least 2 weeks prior to randomization, subjects must be either off steroids or on a stable or decreasing dose of \<= 10 mg daily prednisone (or equivalent), and do not have ongoing neurological symptoms that are related to the brain localization of the disease.
* Other protocol defined criteria could apply
Web-based Support for People With Schizophrenia and Their Families

This study will assess the feasibility of using the internet and in-home computers to provide advice from health care professionals, social support, and health information to people with schizophrenia and their families.

The objective of this study is to assess the feasibility of using the World Wide Web (Web) and in-home computers to provide patients suffering from schizophrenia and their families advice from health care professionals, social support, and information.

The purposes of this intervention are to improve: 1) the availability, convenience and use of needed mental health services; 2) family support for their ill family members; and 3) patient and family outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of schizophrenia Able to speak and read English Regular contact with a family member

Exclusion Criteria:

* Enrolled in another study
Tolerance to Target Doses of Thiazides in Actual Practice: A Feasibility Study

This is a pilot study of a method to compare common, FDA-approved drugs in a clinic. Instead of putting single patients into one of two drug groups, the investigators will assign the doctors who prescribe these drugs for high blood pressure into two groups. One group of doctors has agreed to prescribe mostly ("favor") one drug, chlorthalidone, if that drug would be a good choice for a patient. The other group has agreed to prescribe mostly hydrochlorothiazide. For both groups, they will try to use the doses that were shown to be protective in other trials. If the doctors mostly prescribe the drug they agreed to favor, the investigators will be able to compare outcomes, like heart attacks, in the two groups.


Eligibility Criteria:
Inclusion Criteria:

* VA prescribers of thiazides for hypertension

Exclusion Criteria:

* at non-participating VA sites
Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy in Peritoneal Carcinomatosis From Ovarian Cancer (Cyto-chip 2)

Epithelial ovarian carcinoma (EOC) is one of the main cause of death from cancer in women in the Western world. It is often diagnosed at an advanced stage and the disease remains confined to the peritoneal cavity for much of its natural history. Despite a high rate of response to first-line therapy, about 20% of EOC are naturally resistant to platinum and about 2/3 of patients with initial response will recur within 5 years. Most tumour recurrences will develop resistance to systemic platinum over time. The prognosis of these patients with persistent or recurrence disease remains poor despite salvage therapy including alternative systemic chemotherapy and further cytoreductive surgery (CRS). Since twenty years, centers have pursued comprehensive CRS combined with Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for the management of peritoneal surface malignancies (PSM). This combined approach is the standard of care for the management of some rare peritoneal disease such as pseudomyxoma peritonei or peritoneal mesothelioma. EOC should be an ideal target for this loco-regional treatment, as most of its evolution remains confined to intraperitoneal cavity and because of its sensitivity to chemotherapy. Intraperitoneal chemotherapy has been shown to have significant efficacy in frontline EOC in 3 large randomized studies. Recently, French clinical guidelines have been edited to recommend CRS+HIPEC in patients with ovarian, tubal or primitive carcinomatosis FIGOI IIIC, initially not resectable (Grade B). HIPEC adds some advantages to this intraperitoneal chemotherapy: the hyperthermia effect with its direct cytotoxicity demonstrated in vitro, the synergistic effect with some anticancer agents and, the deliverance immediately following CRS, avoiding the problem of "cancer cell entrapment" by postoperative or posttherapeutic adhesions that limits distribution of chemotherapy agents to all sites. The use of HIPEC for EOC was reported into relatively small case-series from single institutions. Results from a single centre cannot be extrapolated to other centres because of the heterogeneity of patient's selection and HIPEC techniques.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed peritoneal carcinomatosis from ovarian cancer
* Metachronous/synchronous peritoneal carcinomatosis
* Grade FIGO (International Federation of Gynecology and Obstetrics) III or IV
* Peritoneal Cancer Index (PCI) available
* Indication for cytoreductive surgery +/- HIPEC
* Complete macroscopic cytoreduction: CCR (cytoreduction score) -0/1

Exclusion Criteria:

* Non complete macroscopic cytoreduction: CCR (cytoreduction score) -2
* Peritoneal mesothelioma, pseudomyxoma peritonei
* Extra peritoneal metastases
Suboptimal Weight Loss After Gastric Bypass Surgery

Bariatric surgery is the only long-term established treatment for morbid obesity. However, some patients experience suboptimal weight loss after surgery and/or experience a significant weight regain. Unfortunately there are very few studies in this area and little is known about the causes for lack of success or the best approach to treat this group of patients. The main aim of this study is to compare the efficacy of two different lifestyle treatment programs in this group of patients: 1) Hospital-based outpatient program or 2) an inpatient treatment program consisting of 3 - 3-week stays at a rehabilitation center over a 1-year period. Secondary aim is to determine potential reasons for suboptimal weight loss after bariatric surgery.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) \>40kg/m2, or BMI\>35kg/m2 with comorbidities
* healthy volunteers with suboptimal weight loss
* health with significant weight regain after Roux-n-Y Gastric Bypass, defined as failure to lose at least 40% Excess Weight Loss by 12 months postoperatively.

Significant weight regain: Regain of ≥15% of total weight lost after the first postoperative year.

Exclusion Criteria:

* Pregnancy
* enrollment in another obesity treatment
* previous revisional bariatric surgery
* planned bariatric surgery
* past or ongoing drug or alcohol abuse
* physical or mental impairment that interferes with the ability to comply to treatment
* history of severe psychological disorder
* history of severe eating disorder
* current medication known to affect appetite or induce weight loss
Evaluation of a Flexible Videoscope Training Simulator

Flexible bronchoscope or videoscope plays important roles in managing difficult airway. But this technique is time-consuming and very difficult to learn for novices. The investigators design a simple training simulator to help them master this technique.

In this study, residents without operational experience will be recruited. The training effect of the new simulator will be evaluated by comparison with traditional simulation teaching. Participants will receive training with the new simulator or traditional method for 1hour, and then they perform intubation with flexible videoscope in a simulated difficult airway model. The insertion time and success rate will be recorded. Last, they will complete the questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Resident or Medical student
* Willing to participate to the study
* Consent to evaluate the measured data

Exclusion Criteria:

* experienced anesthetists