cyrilzakka/clinical-trials huggingface dataset:
Comparison of Stent Graft, Sirolimus Stent, and Bare Metal Stent Implanted in Patients With Acute Coronary Syndrome

During the 6-month period 119 patients with acute coronary syndrome, were randomized to either stent graft group (n=40), sirolimus eluting stent group (n=39), or bare metal stent group (n=40). Demographic, angiographic and procedural characteristics were similar for all three groups. The incidence of 6-month major adverse coronary events were analysed.

Background: Percutaneous coronary intervention with stent implantation is a standard therapy for patients with acute coronary syndrome. The in-stent restenosis is still a problem. Recently, drug eluting stents reduce the incidence of this unfavorable event. The primary role of the polytetrafluoroethylene stent graft (PTFE) is management of coronary perforations, closure of coronary aneurysms, and in degenerated saphenous vein grafts. We compared these stents in native coronary vessels in patients with acute coronary syndrome with sirolimus and bare metal stents, for possible reduction of in-stent restenosis.

Methods and results: During the 6-month period 119 patients with acute coronary syndrome, were randomized to either stent graft group (n=40), sirolimus eluting stent group (n=39), or bare metal stent group (n=40). Demographic, angiographic and procedural characteristics were similar for all three groups. The incidence of 6-month major adverse coronary events was similar in all three groups. The target lesion revascularisation was higher in the bare metal stent group (P=0.044). The primary end-point, restenosis rate at six-month follow-up was higher in the bare metal stent group, compared with the stent graft and sirolimus eluting stent groups. The percent diameter stenosis in follow-up was significantly higher in bare metal stent group (P=0.005). The late loss was significantly lower in the sirolimus eluting stent group (0.23 mm), compared with the bare metal stent group (P= 0.034). There was a trend of lower late loss in the stent graft group, compared with bare metal stent group.

Conclusion: Three groups of stents implanted in patients with acute coronary syndrome (stent-graft, sirolimus and bare metal), did not differ regarding the incidence of major adverse cardiac events. Sirolimus-eluting stents had a lower incidence of in-stent restenosis in comparison with bare metal stent group. Stent graft implanted in native coronary arteries appears to be safe and efficient in patients with acute coronary syndrome, but a significant reduction of in-stent restenosis was not achieved.

Eligibility Criteria:
Inclusion Criteria:

* stent implantation in acute coronary syndrome

Exclusion Criteria:

* previous percutaneous coronary intervention or coronary artery bypass graft surgery
* multivessel, diffuse disease, tortuous vessel
* arteries less than 3 mm in diameter
* distal stenosis location
* left main and bifurcation lesions
Opioid Free Anesthesia and Bariatric Surgery

The morbidly obese bariatric surgery population is susceptible to opioid-induced complications such as respiratory depression and postoperative nausea and vomiting. This population may in particular benefit from opioid-sparing or opioid-free anesthetic techniques. This study aims to evaluate the effect of opioid free total intravenous anesthesia on postoperative quality of recovery in patients undergoing bariatric surgery.


Eligibility Criteria:
Inclusion Criteria:

* ASA I-III
* Non-pregnant
* Undergoing laparoscopic bariatric surgery for weight loss.

Exclusion Criteria:

* Unable to obtain informed consent or consent withdrawn.
* Patients who are pregnant or nursing.
* ASA IV-V
* Alcohol or narcotic misuse or dependence in the last 2 years.
* Preoperative daily opioid use for one year for pain management.
* Egg or soy product allergy
* Active liver disease
* Patients with left ventricular assist devices
* Abnormal renal function
* Any contraindication to any opioid or non-opioid pain analgesics
* Any physical, mental or medical condition that in the opinion of the investigator, makes study participation inadvisable.
Dengue Virus NS1 Antigen (Bio-Rad) Clinical Protocol

The purpose of the study is to screen blood donors for the presence of NS1 antigen of the dengue virus at the American Red Cross in Puerto Rico region (and Monroe County, Florida) using the Platelia Dengue NS1 Ag enzyme immunoassay.

Dengue is an endemic disease that is increasingly more common in tropical climates and the dengue epidemic in Puerto Rico (May 2009) presents a risk to the blood supply in Puerto Rico. Also, on July 13th 2010 federal officials reported an outbreak of dengue fever in Florida after a survey of Key West residents found that at least 5% had been infected or exposed to the virus. Therefore this IND study is being carried out to identify blood donors carrying the dengue virus using the Platelia Dengue NS1 Ag (Bio-Rad, France). Prospective testing is being performed on blood donors who have read an information sheet regarding the use of donated blood samples in research. Testing will occur at the American Red Cross, Charlotte, NC NTL site.

Eligibility Criteria:
Inclusion Criteria:

The Puerto Rico Region and Monroe County, Florida will maintain a log of all blood donors enrolled by collection date documenting the time of collection, centrifugation and freezing; only centrifuged and frozen PPTs will be sent to the Charlotte NTL for NS1 Ag testing. Samples frozen when received at the Charlotte NTL will be tested. Samples that arrive thawed will be tested if the time unfrozen is 24 hours or less. When necessary, alternate PPTs (surplus samples used for NAT) will be used for dengue NS1 Ag testing; a log will be kept by the Charlotte NTL documenting the sample identification numbers of thawed samples, approximate time unfrozen and the samples that require an alternate PPT for dengue NS1 Ag testing.

Exclusion Criteria:

Samples that are deemed unacceptable for testing include those held for excessive storage times when thawed (in excess of 24 hours unfrozen or otherwise as determined by the Principal Investigator) or that are cracked or otherwise damaged. Samples having inadequate volume for initial and repeat testing in duplicate will not be tested as determined by the Charlotte NTL; a log will be kept of samples unacceptable for testing and the reason that the samples are unsuitable for testing.
Lumbosacral Transitional Vertebra Prevalence Among Egypt Population and Its Association With Lumbar Degeneration

retrospective cross sectional study Study Setting: Cases will be recruited from the recorded data system at the department of diagnostic radiology, Assiut University.

* Study subjects:

  1. Inclusion criteria:

     * All patients underwent MSCT KUB from 2022 till 2023
     * Age between 20-50 years old
  2. Exclusion criteria:

     * All cases below 20 and above 50 .
     * previous history of lumbar spine surgery;
     * non-degenerative pathologies in the lumbar spine which could interrupt the evaluation of lumbar spine degeneration, including spinal tumors, infections, and traumatic fractures;
     * images with poor quality
  3. Sample Size Calculation:

     The study will include all patients underwent KUB CT in Assuit university hospital.

     Objective of this research study will be accomplished through the following consecutive steps:
* Patient Enrolment and sample collection:

Sample are patients underwent MSCT KUB at our hospital , ASSUIT university at one year. Lumbosacral spine will be assessed for LSTV ,the patient images will be divided into two groups ,one which has LSTV as cases and other group with normal spine as control. both groups will be assessed for associated disc degeneration ,facet arthropathy sacroiliac joint degeneration ,paravertebral muscle volume and will be compared with control.

Eligibility Criteria:
Inclusion Criteria:

* • All MSCT KUB studies from 2022 till 2023

  * age between 20-50

Exclusion Criteria:

* All cases below 20 and above 50 .
* previous history of lumbar spine surgery;
* non-degenerative pathologies in the lumbar spine which could interrupt the evaluation of lumbar spine degeneration, including spinal tumors, infections, and traumatic fractures;
* images with poor quality
Study of OCV-501 in Patients With Acute Myeloid Leukemia (AML) (Extension From Study 311-10-001)

The purpose of this study is to assess the safety of OCV-501 in patients with AML who completed the Study 311-10-001 and were judged that there was no relapse by any inspections in the end of the study.


Eligibility Criteria:
Inclusion Criteria:

* Patients who completed the Study 311-10-001 and were judged that there was no relapse by any inspections in the end of the study.
* Patients who are capable of giving informed consent

Exclusion Criteria:

* Patients failed to discontinue the Study 311-10-001 even though patients met the discontinuation criteria.
* Patients who have participated in any other clinical trials , excluding the Study 311-10-001).
Effect of Tranexamic Acid on Prevention of Recurrence of Hemoptysis

Hemoptysis is one of the serious complication of many pulmonary diseases. Upto now, there is no proven medical treatment in recurrence of hemoptysis. The investigators will conduct a randomized, placebo controlled trial of tranexamic acid, which can reduce the recurrence of hemoptysis.


Eligibility Criteria:
Inclusion Criteria:

* age: \>=20 and \<=75
* ER visit or admission for hemoptysis
* no evidence of hemoptysis on screening

Exclusion Criteria:

* anticoagulation treatment
* Cr \>= 2.0 mg/dL or urinary protein \>= 2+ or who received renal replacement treatment
* hepatic failure: total bilirubin \>= 1.5 mg/dL or AST or ALT \>= 1.5 of upper normal limit level
* hypersensitivity to tranexamic acid
* pregnant woman
* fertile female who don't use contraception
Non Grafted Maxillary Sinus Floor Elevation With Implant Placement Versus the Use of Short Endosseous Implants

Assessment the need for sinus floor elevation when restoring atrophic posterior maxilla or it will be enough to use of short implant


Eligibility Criteria:
Inclusion Criteria:

* Patients with partially edentulous in the posterior area of the maxilla, with a residual ridge that allowed insertion of ≤8 mm length implants.
* Both sexes.
* No intraoral soft and hard tissue pathology
* No systemic condition that contraindicate implant placement.

Exclusion Criteria:

* Sinus pathology.
* Heavy smokers more than 20 cigarettes per day.
* Patients with systemic disease that may affect normal healing.
* Psychiatric problems
* Disorders to implant are related to history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site
* Immunodeficiency pathology, bruxism, stress situation (socially or professionally), emotional instability, and unrealistic aesthetic demands.
Physiotherapists' Placebo or Nocebo Communication Regarding VR in CMP

Rationale: Chronic musculoskeletal pain (CMP) is a common and disabling condition. Physiotherapy is the most frequently administered non-pharmacological treatment option for patients with CMP and recently virtual reality (VR) was introduced in physiotherapy care as a novel treatment modality. Proper communication about physiotherapy treatment (modalities) is important to improve treatment outcomes, by applying placebo effects enhancing communication and avoiding nocebo effects enhancing communication. However, yet is still unknown to what extent this applies to communication of physiotherapists about VR in patients with CMP.

Objective: To determine the effect of physiotherapists' placebo or nocebo therapeutic communication about VR, on treatment credibility and expectation in patients with CMP

Study design: Web-based randomized controlled trial.

Study population: 100 participants

Intervention: The placebo intervention group will be shown an educational video about VR, containing placebo effects enhancing verbal language. The nocebo intervention group will be shown an educational video about VR, containing nocebo effects enhancing verbal language.

Primary study parameters: The primary study parameters are treatment credibility and treatment expectation. Treatment credibility and treatment expectations will be measured using the Dutch credibility and expectancy questionnaire (CEQ).


Eligibility Criteria:
Inclusion Criteria:

* aged ≥ 18
* access to the internet
* provide informed consent
* suffers from CMP

Exclusion Criteria:

* lacked comprehension of the Dutch language
* had experience with therapeutic VR
MGTA-145 + Plerixafor in the Mobilization of Hematopoietic Stem Cells for Autologous Transplantation in Multiple Myeloma

This study evaluates a new drug MGTA-145 in combination with plerixafor (Mozobil) to mobilize stem cells into the peripheral blood for collection by apheresis. The stem cells will be used for autologous stem cell transplant for treatment of multiple myeloma.

PRIMARY OBJECTIVE

1. To assess the efficacy of MGTA-145 in combination with plerixafor in mobilizing adequate number of hematopoietic stem cells (\> 2 x 10e6 CD34+ cells/kg) in patients with multiple myeloma (MM) in preparation for autologous stem cell transplantation (ASCT).

SECONDARY OBJECTIVES

1. To assess the efficacy of MGTA-145 and plerixafor in mobilizing different Hematopoietic stem cells (HSCs) target goals in patients with MM in preparation for ASCT.
2. To assess the safety and tolerability of MGTA-145 and plerixafor for mobilizing HSCs in patients with MM.
3. To assess the engraftment rate and time to engraftment following ASCT after HSC mobilization with MGTA-145 and plerixafor in patients with MM undergoing upfront ASCT.
4. To assess rate of ongoing engraftment at Day 30 and 100 after stem cell infusion in patients with MM who are mobilized with MGTA-145 and plerixafor undergoing upfront ASCT.
5. To assess transplant and disease-related outcomes after mobilization of HSCs with MGTA-145 and plerixafor in patients with MM undergoing upfront ASCT.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of multiple myeloma (MM) per the International Myeloma Working Group (IMWG) criteria
* Eligible for autologous stem cell transplantation (ASCT) per institutional guidelines
* Within 1 year of start of therapy for multiple myeloma
* Cardiac and pulmonary status sufficient to undergo apheresis and transplantation per institutional transplant guidelines
* Calculated creatinine clearance \> 30 mL/min, according to the Modification of Diet in Renal Disease (MDRD) formula.
* Absolute neutrophil count (ANC) \> 1500 x 10e6/L
* Platelet count \> 100,000 x 10e6/L
* Ability to understand and the willingness to sign a written informed consent document.
* Agreement to use an approved form of contraception for male patients or female patients of childbearing potential.

Exclusion Criteria:

* History of prior stem cell transplant for multiple myeloma or other indications
* Planned tandem stem cell transplant
* Prior history of failure to collect HSCs.
* Total bilirubin \> 1.5x upper limit of normal (ULN) in the absence of a documented history of Gilbert's syndrome
* Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) \> 3x ULN
* Known allergy to MGTA-145 or plerixafor.
* Lifetime exposure to lenalidomide or another immunomodulatory drug greater than 6 cumulative months of treatment, ie, \> 6 cycles of 28 days or \> 8cycles of 21 days
* Pregnant or lactating
Immunoscintigraphy Using Radiolabeled Monoclonal Antibody in Finding Tumor Cells in Patients With Colorectal Cancer

RATIONALE: Diagnostic procedures, such as immunoscintigraphy, using a radiolabeled monoclonal antibody may help find and diagnose colorectal cancer.

PURPOSE: This clinical trial is studying how well immunoscintigraphy using a radiolabeled monoclonal antibody works in finding tumor cells in patients with colorectal cancer.

OBJECTIVES:

Primary

* To determine the ability of iodine I 123 anti-CEA recombinant diabody T84.66 to localize to colorectal cancer, as determined by quantitative radioimmunoscintigraphy in patients with colorectal cancer.

Secondary

* To evaluate the clinical pharmacokinetics of iodine I 123 anti-CEA recombinant diabody T84.66 clearance in these patients.
* To characterize the frequency and titer of the human anti-chimeric response to iodine I 123 anti-CEA recombinant diabody T84.66 in these patients.
* To determine the safety of iodine I 123 anti-CEA recombinant diabody T84.66 in these patients.

OUTLINE: Patients receive an infusion of iodine I 123 anti-CEA recombinant diabody T84.66. Patients undergo planar imaging every 5 minutes during the radiolabeled antibody infusion and then at 3-6 hrs, 12-24 hours, and, if indicated, 30-48 hours after the radiolabeled antibody infusion. Planar spot images of the head, chest, abdomen, and pelvis and whole body images (anterior and posterior) are taken. Patients also undergo SPECT scan of the abdomen and pelvis at 12 and 24 hours after the radiolabeled antibody infusion.

Blood samples are collected for pharmacokinetic analysis immediately after the radiolabeled antibody infusion and then at 15 minutes, 30 minutes, 1 hour, 2 hours, and 4 hours after the radiolabeled antibody infusion.

Patients are followed periodically for 6 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed colorectal cancer

  * Stage I-IV disease

PATIENT CHARACTERISTICS:

* Serum creatinine \< 2.0 mg/dL
* Total bilirubin \< 2.0 mg/dL
* Hemoglobin \> 9.0 g/dL
* cT84.66 antibody negative (if previously treated with mouse or chimeric immunoglobulins)
* Not pregnant
* No condition that, in the opinion of the investigator, would preclude study compliance
* No known allergy to iodine
* No known history of HIV, hepatitis B, or hepatitis C

PRIOR CONCURRENT THERAPY:

* No concurrent steroids
To Determine the Effects of Deodorant, Antiperspirant and Washing on the Pharmacokinetics of 2% Testosterone MD Lotion

Testosterone replacement treatment is the most effective way of treating hypogonadism in men.

Acrux has a propriety testosterone replacement product, Testosterone MD-Lotion and this study will evaluate the impact of application of antiperspirant and deodorant on absorption of testosterone, when applied pre-application of Testosterone MD-Lotion® (cutaneous solution).

The study also aim to evaluate the impact of washing the application site on the absorption of testosterone, when washed post-application of Testosterone MD-Lotion® (cutaneous solution).


Eligibility Criteria:
Inclusion Criteria:

* Healthy premenopausal female subjects ≥18 and ≤45 years of age with qualifying general medical health.

Exclusion Criteria:

* Disqualifying concurrent condition or allergy/sensitivity to testosterone replacement therapy.
Sleep Infra-slow Oscillations III

In young healthy subjects, we will apply sensory stimuli at specific times during sleep to evaluate the probability that the stimulus evokes an arousal.


Eligibility Criteria:
Inclusion Criteria:

* Willingness to participate and written informed consent
* Aged 20 to 40 years at the time of screening
* Body mass index (BMI) ≤ 30

Exclusion Criteria:

* Pregnancy or breast feeding at the time of screening
* Sleep related breathing disorders
* Any other sleep related breathing disorder according to AASM criteria
* Current history of psychiatric disorders according to DSM-V
* Current chronic treatment that may affect sleep
* Any significant neurological disorder or other medical disease that may affect sleep
* Any unstable medical condition
* Any clinically significant sleep disorder
PF-06741086 Long-term Treatment in Severe Hemophilia

This study is designed to evaluate the safety, tolerability and efficacy of long-term treatment with PF-06741086 in subjects with severe hemophilia who participated in the 3-month Phase 1b/2 B7841002 study. Additionally, de novo subjects will be recruited into this study.


Eligibility Criteria:
Inclusion Criteria:

* Severe hemophilia A or B (Factor VIII or Factor IX activity ≤ 1%)
* Subjects enrolled as Factor VIII or Factor IX inhibitor patients must have a positive inhibitor test result (above the upper limit of normal) at the local laboratory and must receive a bypass agent as primary treatment for bleeding episodes.
* Episodic (on-demand) treatment regimen prior to screening
* At least 6 acute bleeding episodes during the 6-month period prior to screening

Exclusion Criteria:

* Known coronary artery, thrombotic, or ischemic disease
* Concomitant treatment with activated prothrombin complex concentrate
Real-World Betaseron Health Economic Outcomes Study for Relapsing Forms of Multiple Sclerosis

A Web based real world observational study in Relapsing-Remitting Multiple Sclerosis (RRMS) population capturing outcomes reported by patients and by the physicians during 12 months after initiating or resuming Betaseron.


Eligibility Criteria:
Inclusion Criteria:

* Provides written informed consent to participate in the study
* At least 18 but no more than 65 years old
* Documented clinical diagnosis of a relapsing form of multiple sclerosis or confirmed clinically isolated syndrome (CIS)
* Initiating Betaseron therapy, or resuming Betaseron after not having used it for at least three months
* Willing and able to provide a valid e-mail address which will be in use for the duration of the study
* Willing and able to complete study questionnaires via the Internet
* Has reliable Internet access for the duration of the study
* Completes the baseline patient questionnaire

Exclusion Criteria:

* Kurtzke Expanded Disability Status Scale (EDSS) score greater than 6.0
* Cognitive dysfunction that, in the Investigator's judgment, raises doubts about the study participant's ability to provide informed consent or accurately complete the monthly patient questionnaire
* Any use of Betaseron within the three months prior to study entry
* Inability to read, write, or speak the English language
* Illness or disease other than multiple sclerosis that the Investigator believes is likely to cause the patient's death or incapacity within twelve months
* Any severe, uncontrolled illness or condition that the Investigator believes could dominate the patient's quality of life
* Coexistent autoimmune disease such as rheumatoid arthritis, lupus, or psoriasis that is likely to be exacerbated by treatment with Interferon
* Current use of any immunosuppressive medication
* Previous participation in a multiple sclerosis (MS) clinical trial within the three months prior to study entry
* Previous use of monoclonal antibodies treating MS within the three months prior to study entry
* Current use of any secondary treatment for multiple sclerosis other than the episodic use of steroids during relapses or exacerbations