cyrilzakka/clinical-trials huggingface dataset:
Efficacy of a New Resurfacing Hip Prosthesis

The purpose of this study is to compare the articular surface replacement (ASR) prosthesis placed by the conventional positioning method and the ASR prosthesis placed by 'computer assisted surgery' (CAS) in variation between pre planned position of the femoral component and the actual position of the femoral component of the prosthesis. The hypothesis is that this variation is larger with the conventional positioning method than when CAS is used.

For patients who suffer from end stage of osteoarthritis of the hip, a joint replacement could result in an obvious improvement of the quality of life. However, because of the life expectation and high level of activity of young and active patients, the conventional total hip replacement does not offer an optimal solution.

An alternative to a total hip replacement in young and active patients is the resurfacing hip prostheses. The articular surface replacement (ASR) hip prostheses can be placed by the conventional positioning method and by using 'computer assisted surgery' (CAS). The hypothesis is that the positioning of the femoral component by the conventional positioning method will show a larger variation between pre planned and actual position than when CAS is used.

This study will compare the results of those who had an ASR prosthesis placed by the conventional positioning method with those patients in whom the ASR prosthesis was placed using CAS.

Eligibility Criteria:
Inclusion Criteria:

* Men aged ≤ 60 years, and women aged ≤ 55 years
* Presence of evident clinical and radiological osteoarthritis of the hip, indicated for a joint replacement surgery

Exclusion Criteria:

* Evident osteoporosis
* Active local or systemic infection
* Clinical manifestation of vascular deficiency of the lower extremity
* Pathological condition of the acetabulum
* Presence of evident clinical and radiological avascular necrosis of the femoral head, hip dysplasia, slipped capital femoral epiphysis, Legg-Calve- Perthes disease
* Rheumatoid arthritis
* Extreme varus position (neck-shaft angle \< 110º)
* Presence of femoral cyst \> 1 cm in diameter
* Previous hip surgery
* Presence of bilateral hip pathology, which may lead to joint replacement surgery within 1 year
* Presence of a THR at the contra lateral site less than 6 months post- operatively or patients with a THR at the contra lateral site with a poor function of the hip
* BMI\> 30 kg/m2
* Renal deficiency (creatine \> 115 μmol/l for men and \> 90 μmol/l for women)
* Medically proven metal allergy
* Request of patient to correct an existing leg length discrepancy
* Head-neck ratio \< 1
* Use of steroids, and/or immunosuppressive medication
* Alcoholism
* Patients from which it is not sure that they will be able to attend the follow-up measurements
* Insufficient command of the Dutch language, spoken and/of written
Esmolol Infusion in Patients Undergoing Craniotomy

Anesthesia techniques that minimize anesthetic requirements and their effects may be beneficial. Esmolol, a short acting hyperselective β-adrenergic blocker is effective in blunting adrenergic response to several perioperative stimuli and so it might interfere in the effect of the anesthetic drugs on the brain. This study was designed to investigate the effect of esmolol on the consumption of propofol and sevoflurane in patients undergoing craniotomy.

Patients undergoing elective craniotomy for aneurysm clipping or tumor dissection were randomly divided in two groups (four subgroups). Anesthesia was induced with propofol, fentanyl and a single dose of cis-atracurium, followed by continuous infusion of remifentanil and either propofol or sevoflurane. Patients in the esmolol group received 500 mcg/kg of esmolol bolus 10 min before induction of anesthesia, followed by additional 200 mcg/kg/min of esmolol. Monitoring of the depth of anesthesia was also performed using the Bispectral Index-BIS. It was also performed monitoring of the cardiac output in order to evaluate the effect of esmolol on cardiac output.

The inspired concentration of sevoflurane and the infusion rate of propofol were adjusted in order to maintain a BIS value between 40-50.

Intraoperative emergence was detected by the elevation of BIS value, HR or MAP.

It was recorded intraoperative fluctuations of propofol and sevoflurane in both groups. Data were expressed as mean ± SD. Differences in categorical data were evaluated using the student t test.

Eligibility Criteria:
Inclusion Criteria:

* Patients with ASA physical status 1-3
* Glasgow Coma Scale:15

Exclusion Criteria:

* Patients with ASA physical status \>3,
* Body Mass Index (BMI) over 30,
* indication for rapid sequence induction,
* any contraindication for receiving b-blocker,
* chronic use of b-blocker,
* Glasgow Coma Scale (GCS) \<15,
* history of drug abuse,
* severe mental impairment,
* preoperative aphasia,
* neurologic deficit or preoperatively foreseen delayed extubation.
Study of Ozanimod (RPC1063) in Relapsing Multiple Sclerosis (MS)

The purpose of this study is to determine whether ozanimod is effective in the treatment of relapsing multiple sclerosis (RMS).


Eligibility Criteria:
Inclusion Criteria:

* Multiple sclerosis as diagnosed by the revised 2010 McDonald criteria
* EDSS score between 0 and 5.0 at baseline

Exclusion Criteria:

• Primary progressive multiple sclerosis
Prophylactic Early PN in HPT/BMT

Supplemental prophylactic early parenteral nutrition will be commenced 1 day prior to conditioning chemoradiotherapy in patients who are not already malnourished. Supplemental parenteral nutrition continues throughout conditioning chemoradiotherapy and stem cell transplant.

A standard parenteral nutrition solution will be used. The parenteral nutrition solution will be given once daily, and infused intravenously. The standard parenteral nutrition solution will contain approximately 40 grams of amino acids/L, 40 g lipids/L and 100g dextrose/L). Nutritional targets will be measured using indirect Calorimetry where available, or calculated via the Harris Benedict or Schofield equations. The dose of parenteral nutrition administered will be determined by the treating dietitian, treating physician or treating research team. The parenteral nutrition dose given will be individualised considering the patients clinical condition and body weight. The dose of supplemental parenteral nutrition will be dependent on the total calories also received from oral and/or enteral nutrition intake.

Supplemental parenteral nutrition will be discontinued when a patient is well enough to be discharged from hospital or when the patients attending clinician determines a central line is no longer needed for standard care. There is no maximum duration of supplemental parenteral nutrition..

Adherence to the study intervention will be monitored via medical chart reviews during site monitoring visits, and data queries on individual patient case report form documentation.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are about to commence conditioning chemoradiotherapy for allogeneic haematopoietic progenitor/stem cell transplantation, who have a haematological malignancy, who are not meeting 80% of their Caloric needs via oral or enteral intakes, and who are not malnourished.

Exclusion Criteria:

* Patients who are already receiving parenteral nutrition at time of screening.
* Patients with a documented licensing contraindication to parenteral nutrition.
Hospital-Based Cluster Trial: Magnetically Controlled Growing Rods Using Distraction Intervals

A hospital-based cluster stratified randomization control study will be conducted to investigate spinal growth in Early Onset Scoliosis patients between 5 and 9 years of age. Patients must have a major coronal curve measuring over 50 degrees and be undergoing Magnetically Controlled Growing Rod treatment. We will be studying 6-week lengthening intervals compared to 16-week lengthening intervals on spinal growth within 3 years.

The Magnetically Controlled Growing Rod (MCGR) system consists of growing rods similarly implanted as with traditional approaches, but with subsequent noninvasive distractions. The implanted growing rods are magnetically controlled and adjusted outside the body using an external remote controller (ERC) following initial surgical insertion. No incision or anesthesia are used for rod lengthening procedures and they are performed by the surgeon in an outpatient or office setting. The purpose of this study is to determine the effect of a 6-week lengthening interval compared to a 16-week lengthening interval on spinal growth in Early Onset Scoliosis patients between 5 and 9 years of age with a major coronal curve over 50 degrees undergoing MCGR treatment within 3 years.

Eligibility Criteria:
Inclusion Criteria:

* All patients with diagnosis of Early Onset Scoliosis (scoliosis before age 10)
* Between 5 and 9 years of age (5.0 to 9.9 years)
* Major curve greater than 50 degrees at time of index surgery
* Dual-rod Magnetically Controlled Growing Rod implantation only
* Spine or rib-based constructs
* Pre-operative and intra-operative halo gravity traction is allowed

Exclusion Criteria:

* Patients with previous spine surgery, including other growth friendly techniques
* Patients who cannot abide by the study requirements due to geographical or other similar constraints
Wireless Stimulation Endocardially for Cardiac Resynchronization Therapy

The WiCS-LV system is an alternative means to providing left ventricular stimulation for Cardiac Resynchronization Therapy (CRT). The purpose of this study is to evaluate the safety and performance of the WiCS-LV System in patients with indications for CRT.

Eligible patients will undergo an acoustic window assessment using transthoracic echocardiography. Patients with adequate acoustic windows will undergo implantation of the WiCS-LV system.

Patients will undergo evaluations pre-hospital discharge, and at one month, 3 months, and 6 months post implantation. Extended follow-up will be obtained via a registry at 1, 2, 3, 4, and 5 years post implantation.

Eligibility Criteria:
Inclusion Criteria:

Patients with standard indication for CRT based upon the most recent guidelines AND meeting criteria for one of these three categories:

1. Patients with previously implanted pacemakers or ICD's and meeting standard indications for CRT - referred to as "upgrades"
2. Patients in whom attempted coronary sinus lead implantation for CRT has failed - referred to as "untreated"
3. Patients with previously implanted CRT device, not responding to CRT (no change or worsening of symptom or NYHA functional class after 6 months of treatment confirmed by investigator) - referred to as "non-responders"

Exclusion Criteria:

1. Inability to comply with the study follow-up or other study requirements
2. Contraindication to heparin
3. Contraindication to both chronic anticoagulants and antiplatelet agents
4. Contraindication to iodinated contrast agents
5. Intracardiac thrombus by transesophageal echocardiography
6. Age less than 18 years
7. Attempted IPG implant within 3 days
8. Life expectancy of \< 12 months
9. Chronic hemodialysis
10. Myocardial infarction within one month
11. Major cardiac surgery within one month
12. Female of childbearing potential, pregnant, or breastfeeding
13. Noncardiac implanted electrical stimulation therapy devices
ERECTOR SPINAE BLOCK AFTER THORACIC SPINE SURGERY

the effectiveness of ultrasound guided erector spinae plane block in patients undergoing thoracic spine sugery

bilateral erector spinae plane block would be given to patients with thoracic spine sugery for postoperative analgesia \& its effectiveness would be evaluated for 2 days

Eligibility Criteria:
Inclusion Criteria:

* postoperative thoracic spine sugery

Exclusion Criteria:

* less then 18 years
* more than 65 years
Left Atrial Volume Index and Left Atrial Appendage Flow Velocities

After obtaining a consent, bed side cardiac ultrasonography will be performed for cases undergoing transesophageal echocardiography to evaluate the correlation between left atrium volume and left atrial appendage flow velocity which can predict the thrombosis risk.

Informed consent will be obtained prior to any research related procedures Prior to performing the transesophageal echocardiography, 4 and a 2-chamber transthoracic images will be obtained to perform standard left atrial volumetric assessment as well as speckle tracking interrogation. Both these procedures will be performed offline. The transesophageal echocardiography will be performed using available equipment with a 5- to 7-megaHertz multiplane transducer and according to standard of care. All images will be acquired per American Society of Echocardiography guidelines and will be recorded for further analysis. The left atrial appendage will be best visualized in the 60, 90 and 110 degree imaging planes and left atrial appendage contraction velocity will be recorded by placing a pulsed wave Doppler sample volume inside the proximal third of the left atrial appendage at each angle. In addition, images will be recorded using a 3-beat cycle capture to later perform offline velocity vector imaging analysis for left atrial appendage speckle tracking analysis. The transthoracic echocardiography will be performed just before the transesophageal echocardiography examination using a 2- to 4-megaHertz transducer and according to standard practice guidelines. The following echocardiographic variables will be prospectively measured and calculated: left ventricle ejection fraction using Simpson method, left atrial volume will be measured using biplane method and left atrium volume index is calculated based on body surface area. Tissue Doppler images of mitral valve annulus will be measured and Pulsed wave Doppler of mitral inflow velocity.

Study does not include follow up. Study duration is up to 24 months

Eligibility Criteria:
Inclusion Criteria:

* Study will include all patients 18-80 years of age and referred for transesophageal evaluation of left atrium or left atrium appendage for appropriate clinical indications, at the University of Cincinnati University Medical Center and VA Medical Center.

Exclusion Criteria:

* Patients with either moderate to sever mitral valve disease or previous prosthetic mitral replacement.
* Patients with acute heart failure
* History of previous left atrium appendage surgical intervention.
* Pregnant women
Interferon Gamma in Treating Patients With Recurrent or Metastatic Melanoma or Other Solid Tumors

RATIONALE: Interferon gamma may interfere with the growth of cancer cells and may be an effective treatment for melanoma and solid tumors.

PURPOSE: Phase I trial to study the effectiveness of interferon gamma in treating patients with recurrent or metastatic melanoma or other solid tumors.

OBJECTIVES: I. Determine the maximum tolerated dose of intratumoral adenovirus vector containing interferon gamma in patients with locally recurrent or metastatic melanoma or other solid tumors. II. Assess the safety and tolerability of this regimen in this patient population. III. Determine the local or distant antitumor effect of this regimen in these patients. IV. Evaluate the biological and immunological effects of this regimen and the extent of local interferon gamma expression in these patients.

OUTLINE: This is a dose escalation study. Patients receive adenovirus interferon gamma intratumorally on days 1, 8, and 15. Patients achieving tumoral response may receive additional courses of therapy at the discretion of the investigator. Cohorts of at least 3 patients receive escalating doses of adenovirus interferon gamma until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 3 of 6 patients experience dose limiting toxicity. Patients are followed for 3 weeks after treatment.

PROJECTED ACCRUAL: A minimum of 12 patients will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed malignant melanoma or other solid tumor not amenable to curative therapy Locally recurrent OR Metastatic disease Suitable cutaneous or nodal sites for intratumoral injection No uncontrolled CNS metastases Brain metastases allowed if stereotactically or surgically treated, well controlled, and not requiring systemic corticosteroids

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Hemoglobin at least 10.0 g/dL WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) SGPT/SGOT no greater than 3 times ULN Renal: Creatinine no greater than 2 times ULN Other: HIV negative No active systemic infection No other serious systemic medical conditions Positive delayed hypersensitivity reaction to at least one of the following antigens: tetanus, candida, mumps, or trichophyton Not pregnant Fertile patients must use effective contraception during and for 3 months after study

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since prior immunotherapy for melanoma No other concurrent immunotherapy Chemotherapy: At least 3 weeks since prior systemic chemotherapy for melanoma No concurrent chemotherapy Endocrine therapy: No concurrent systemic corticosteroids Radiotherapy: No concurrent radiotherapy Surgery: Not specified Other: No other concurrent investigational therapy
Association Between Framingham Risk Score, hsCRP and Vascular Inflammation: Analysis With 18F-Fluorodeoxyglucose Positron Emission Tomography

Framingham risk score is well known screening tool that detect cardiovascular (CV) risk. But it is not suitable for CV risk in mild risk group. So 18F-fluorodeoxyglucose positron emission tomography (FDG-PET) is a new imaging technique for detecting vascular inflammation within atherosclerotic plaques and hsCRP is also arising detection tool of CV risk.

The investigators are examining this association in normal and impaired glucose tolerance patients groups.

We examined vascular inflammation using FDG-PET scan in 178 subjects (Normal and impaired glucose tolerance groups). Vascular 18F-FDG uptake was measured as both the mean and maximum blood-normalized standardized uptake value (SUV), known as the target-to-background ratio (TBR). And We analyzed that the association with Framingham risk score, hs CRP and vascular inflammation by FDG-PET scan.

Eligibility Criteria:
Inclusion Criteria:

* healthy subjects

Exclusion Criteria:

* a history of cardiovascular disease (myocardial infarction, unstable angina, stroke or cardiovascular revascularization)
* active inflammatory disease, recent active infection
* stage 2 hypertension (resting blood pressure, ≥ 160/100 mmHg)
* diabetes mellitus
* systemic disorders such as severe hepatic, renal, and hematologic diseases
* taking drugs known to interfere with vascular inflammation measured by FDG-PET.
Magic Mouthwash Plus Sucralfate Versus Benzydamine Hydrochloride for the Treatment of Radiation-induced Mucositis

Radiation treatment is very effective for treating cancers of the head and neck, however, during the course of treatment, it is common for patients to experience soreness of their mouth and throat due to the radiation. When radiation causes inflammation of the inside of the mouth, it is called 'mucositis'. There are several mouthwashes that are commonly used to prevent and treat mucositis, but none of these have been shown to be superior to another. This study is being conducted to see if using a combination of magic mouthwash and sucralfate is better than using a single mouthwash called benzydamine at decreasing the burden of mucositis.

Sixty patients with head and neck cancer being treated with 6 or more weeks of radiotherapy, will be randomly assigned to receive either a combination of magic mouthwash (diphenhydramine, dexamethasone and nystatin) plus sucralfate or benzydamine. Patients randomized to receive magic mouthwash plus sucralfate will rinse first with 5ml of the magic mouthwash for 2 minutes then swallow, followed by rinsing with 5ml of the 1g/5ml sucralfate for 2 minutes before swallowing, 4 times daily. Patients randomized to receive 0.15% benzydamine HCl will be instructed to rinse with 15ml of the solution for 2 minutes before expectorating, 4 times daily. Patients will start the mouthwash regimens prior to the initiation of radiotherapy, and stop 2 weeks after the completion of radiotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven squamous cell carcinoma of the head and neck.
* Receiving 6 or more weeks of external beam radiotherapy to a treatment volume that includes mucosal surfaces of the head and neck.

Exclusion Criteria:

* Age less than 18 years
* ECOG Performance Score 2 or higher
* Patient is unable to understand the protocol and/or unable to provide informed consent
* Patient is unable or unwilling to complete the questionnaires which are written in English.
* Prior radiation to the head and neck region that would result in overlap of fields for the current study.
* Plan to receive a radiation treatment volume that only includes the larynx and or hypopharynx with no planned treatment of locoregional lymph nodes.
* Plan to receive a concurrent chemotherapy agent other than cisplatin.
* Plan to receive other investigational agents (eg. panitumumab).
* Investigational agent of any kind within 30 days prior to randomization.
* Concurrent administration of any other experimental intervention given for the purpose of preventing oral mucositis.
* History of allergic or hypersensitivity reactions to any of the possible agents to be administered in the study.
* Patients who are pregnant or lactating.
Safety and Efficacy Study of Ex Vivo Immunotherapy for Treatment of Aplastic Anemia

Our hypothesis is that ex vivo activated immune cells would produce multiple known and unknown potent hematopoietic cytokines, working in concert, these cytokines help stem cell growth and differentiation. Additionally, these cells travel and home to bone marrow as well as spleen and liver involved in hematopoietic activities, where direct cell-cell contact may be beneficial.

Patients will be required to stay in our hospitals to receive the immunotherapy. Allogeneic peripheral blood mononuclear cells from healthy donors and the autologous peripheral mononuclear cells will alternately used for the treatment. Patients are expected to spend at least 6 to 12 months in the hospital and won't be released until they have improved significantly.

Eligibility Criteria:
Inclusion Criteria:

* Clinical Diagnosis of Idiopathic Aplastic Anemia
* Not Eligible for Bone Marrow Transplantation
* Not Responsive to Conventional Immunosuppressive Therapy

Exclusion Criteria:

* Leukemia or MDS or PNH or Fanconi's Disease
* pregnancy
* Allergic to Blood Product
* Severe Hypertension or Heart Disease
* Liver or Kidney Disease