cyrilzakka/clinical-trials huggingface dataset:
Vaccination Adjuved Against Hepatitis B in SNS Workers Typed as no Responders to Conventional Vaccines

Health workers with biological risk in their tasks, who have been vaccinated as non-responders to conventional vaccination against Hepatitis B. To provide Health workers-staff with an additional protection tool against hepatitis B infection. To evaluate the efficacy of the adjuvanted vaccine in healthy nonresponders to conventional hepatitis B vaccine.

An interventional, phase 4, single group assignment, without masking (open label), preventive clinical trial was carried out in health workers with biological risk in their tasks, who have been filed as non-responders to conventional vaccination against Hepatitis B.

Methods: 67 health workers with biological risk in their tasks, who have been filed as non-responders to conventional vaccination against Hepatitis B, were enrolled in the Clinical Trial. All participants were from 18 years up to 64 years old. The criteria defining them as non-responders to the conventional hepatitis B vaccine is anti HBsAb titers \< 10 mUI/ml following the application of six doses of conventional vaccine at 20 lg doses (two complete guidelines). The objective of this study was to provide Health workersstaff with an additional protection tool against hepatitis B infection, and to evaluate the efficacy of the adjuvanted vaccine in healthy non-responders to conventional hepatitis B vaccine.

Eligibility Criteria:
Inclusion Criteria:

* NHS workers -including university students doing their internships in health centres dependent on the National Health System (inclusion of students is regulated and limited by specific instructions on labour prevention in each autonomous community).
* Criteria defining them as NO responders to the conventional hepatitis B vaccine: anti HBsAb titers \<10 mIU / ml following the application of six doses of conventional vaccine at 20 μg doses (two complete guidelines).

Exclusion Criteria:

* Known allergy to the active substance or any of the other ingredients of the medicinal product (included in section 6 of the product data sheet).
* Subjects that have ever had an allergic reaction to any vaccine against hepatitis B.
* Subjects have a serious infection with fever.
* Subjects for whom informed consent is not obtained.
* Subjects that have not revoked the consent initially signed.
The Effect of Cross-Education on Shoulder Arthroscopy

The purpose of this study is to examine the effectiveness of a strength training protocol on the uninjured upper extremity either alone or with the addition of blood flow restriction (BFR) training on subjects who have undergone shoulder arthroscopy.

The purpose of this study is to examine the effectiveness of a strength training protocol on the uninjured limb either alone or with the addition of blood flow restriction (BFR) training on the status of the injured limb post shoulder arthroscopy. Patients will be randomized into one of three standardized physical therapy (PT) groups after shoulder arthroscopy: Control group (CON), Strength Training on the uninvolved shoulder (STR), strength training with the BFR on the uninvolved shoulder (BFR). All three patient groups will follow a standardized PT rehab protocol that is usual standard of care on the involved shoulder. The STR and BFR group will follow a typical standard of care rehab protocol to the uninvolved side to investigate the potential effects of cross-education. Isometric strength will be assessed utilizing handheld dynamometry (HHD) at Kerlan-Jobe during their regularly scheduled pre-operative and follow-up visits. Patients age 18 and older undergoing shoulder arthroscopy for rotator cuff repair and/or biceps tenodesis. The study includes 3 visits which are standard of care pre-operative and post-operative visits. The duration of the study will be 14 weeks. 2 weeks to allow for a pre-op baseline strength assessment and 12 weeks post-op for the final assessment during the patients routine follow-up visit. Physical Therapy will be standardized for all three groups in terms of frequency and rehabilitation protocol. The only exercises that will be added will be to the intervention groups on the uninvolved side. Patients will present to physical therapy 2-3 times/week during the duration of the study regardless of their group allocation.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* Diagnosed with rotator cuff injury
* Scheduled for rotator cuff surgery via shoulder arthroscopy

Exclusion Criteria:

* Less than 18 years old
* History of previous contra-lateral surgery or injury
* Previous ipsi-lateral upper extremity surgery
* History of shoulder osteoarthritis
Effect of Different Dosing Regimens of Clopidogrel Before Elective Percutaneous Coronary Intervention (PCI) on Platelet Function

Adequate platelet inhibition before percutaneous coronary intervention (PCI) reduces peri-procedural and long-term ischemic complications. Documented reduced response to clopidogrel has been associated with subsequent major adverse cardiovascular events. Strategies to optimize platelet inhibition pre-PCI are under investigation.

This study sought to evaluate the effect on platelet aggregation of four different dosing regimens of clopidogrel given before elective PCI.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient with an indication for elective coronary angiography with or without PCI

Exclusion Criteria:

* major hemorrhagic diathesis or active bleeding
* acute myocardial infarction (MI) within 14 days of enrolment
* unstable angina with ST-segment changes \>1 mm in at least two contiguous electrocardiographic leads at rest or a troponin I level \>0.06 microg/L within 14 days of enrolment
* stroke within the past 3 months
* platelet count \<100 x 10 9/L
* prothrombin time \> 1.5 times control
* hematocrit \<25% or hemoglobin level \<100 g/L
* alcohol or drug abuse
* enrolment in other investigational drug trials within the previous month
* use of thienopyridines, glycoprotein (GP) IIb/IIIa inhibitors, warfarin or acenocoumarol within the previous week
* allergic reaction or any contraindication to clopidogrel or aspirin administration
A New EBV Related Technologies of T Cells in Treating Malignant Tumors and Clinical Application

The purpose of this study is to evaluate the safety of the designed LMP1-CAR -T cells and determine whether the CAR-T cells are effective in the treatment of EBV associated malignant tumors.

Half of the patients will treat with LMP1-CAR-T cells,while the other half will receive a placebo.During the time of the treatment ,we will supervise the side effect of treated group.At last we compare the survival rate and health condition of the two groups.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of nasopharyngeal carcinoma

Exclusion Criteria:

* •pregnant woman

  * severe autoimmune diseases
  * serious infection
The Use of an Acellular Dermal Matrix in a Two-Staged Breast Reconstruction

This study intends to compare postoperative outcomes of a tissue expander placement following a mastectomy with two different operative techniques. This study will be randomized and double blinded comparing the traditional placement of the tissue expander under an inferolateral serratus muscle flap to a new technique which uses an acellular dermal matrix as an inferolateral sling, instead of the muscle flap.

The study we are proposing will evaluate the question of whether there is a difference between the traditional method of serratus flap and the new technique of using an acellular matrix with tissue expander placement. This will be a double blinded randomized study of thirty women in each group comparing outcomes which will include postoperative pain, complications (wound infection, hematoma, capsular contracture, etc), and patient satisfaction with the procedure.


Eligibility Criteria:
Inclusion Criteria:

* Patients presenting to Dr. Wendel's clinic who are older than 17 years of age undergoing a mastectomy and wish to have breast reconstruction with a tissue expander or those who have previously undergone a mastectomy and are now seeking reconstruction will be solicited for the study.

Exclusion Criteria:

* Preoperative radiation therapy
* Autoimmune disease
* Fever
* Uncontrolled diabetes mellitus
* Inability to comprehend or cooperate with postoperative instructions
* Local or systemic infection
* Have any allergies to the excipient ingredients found in the matrix
* Pregnancy
* Low vascularity of the surrounding tissue
* Mechanical trauma
* Poor nutrition
* Poor general medical condition
Accuracy of 3-dimensional Printed Implant Cast Versus Conventional Stone Cast for Edentulous Mandibular Arch

This study will be conducted to compare between accuracy of 3D printed implant cast produced from digital impression and conventional stone cast produced from conventional splinted open tray impression for edentulous mandibular arch with four implants.


Eligibility Criteria:
Inclusion Criteria:

* • Patients were healthy and free from all systemic diseases that affect osseointegration or bone resorption around the implant as recorded from medical and dental history.

  * Patients were free from all oral pathological conditions and any remaining roots which were verified by pre-operative panoramic radiograph.
  * Patients with U shaped arch, flat mandibular alveolar ridge covered with even compressibility healthy mucosa and gingival thickness of about 2mm verified by dual scan of cone beam computed tomography (CBCT) during treatment planning. Fig.(1)
  * Adequate residual alveolar bone quality D2 bone type in the anterior and premolar regions according to the Misch bone density classification scheme (850 to1250 housefield units) confirmed by CBCT.
  * Angel's class I maxillomandibular relation with moderate inter- arch space (20 mm) confirmed through tentative jaw relationship, and restorative space of at least 15 mm determined by putty index technique
  * Patients complain from poor retentive mandibular denture seeking for alternative fixed options.
  * Patient who is motivated, agreed with the follow-up visits and willing to return for follow-up appointments.

Exclusion Criteria:

* • Patient with absolute contraindications that interfere with surgical placement and osseointegration of implants as uncontrolled diabetes mellitus, generalized osteoporosis, recent myocardial infarction, patient with radiotherapy.

  * Patient with relative contraindication such as UN controlled diabetes mellitus, moderate smoking and alcoholism, patient with TMJ disorder and heavy smokers for more than10 cigarettes per day.
  * Patient with local contra indication as insufficient bone quality, localized lesion in canine area and premolar area, unfavourable position of the lower alveolar or mental nerve, bone defects as verified by cone beam CT.
  * Uncooperative patient.
Erythropoietin Alfa in Elderly Subjects With Unexplained Anemia

The primary objective of this study is to assess the ability of epoetin alfa to raise hemoglobin (Hb) levels in elderly outpatients with unexplained anemia. The secondary objectives of this study are to assess the ability of epoetin alfa to improve physical function; cognitive function; and quality of life, and to assess the safety of epoetin alfa in the study population.

Eligible subjects will be recruited out of the companion study "Anemia in the Elderly" (NCT00640172), after active participation in that study is complete. Subjects will have had a full hematologic evaluation, and unexplained anemia will have been previously defined.

Subjects will provide baseline physical function testing, including exercise testing on a treadmill and testing how far patients can walk in 6 minutes (walk test), as well as quality of life; activity level; and mental functioning.

Study visits will be weekly, and the dose level may be adjusted to achieve the target hemoglobin level within 16 weeks. Once at target, the drug will be taken for a total of 12 additional weeks. The maximum time on the study drug could be 28 weeks, and the minimum time be on the 14 weeks.

The walk tests and questionnaires will be repeated when the target hemoglobin level is reached, and when treatment is completed. The tests about quality of life, activity level, and mental functioning will be repeated at the end of treatment. Follow-up visits will be every 4 weeks for 12 weeks to check for side effects.

Eligibility Criteria:
INCLUSION CRITERIA:

* Aged ≥ 65
* Hb ≤ 11 g/dL
* Outpatient at either the VA Palo Alto Health Care Systems (VAPAHCS) or Stanford Hospital and Clinics (SHC)
* Independently living in the community (ie, not institutionalized or living in a group home)
* Ability to understand and the willingness to sign a written informed consent document
* Performance level ECOG 2 or better
* Diagnosis of unexplained anemia

EXCLUSION CRITERIA:

* Substance abuse or mental health or other problems that would affect compliance with the protocol
* Predicted mortality based on co-morbidities of less than 3 months
* On any erythropoiesis-stimulating agent in the prior 3 months
* Known HIV; hepatitis B; or hepatitis C chronic infection
* Clinically significant and uncontrolled medical condition considered a high risk for participation in an investigational study
* Serum albumin \< 3 g/dL
* Use of an investigational medication or participation in an investigational study within 4 weeks prior to enrollment in the trial
* Liver disease as defined as total bilirubin ≥ 2 g/dL or AST/ALT ≥ 2 times the upper limit of normal
* Allergy to recombinant human erythropoietin
* Estimated glomerular filtration rate by Modification of Diet in Renal Disease (MDRD) equation of \< 30 mL/min/1.73 m2 or dialysis
* History of proximal deep venous thrombosis or pulmonary embolism within the past 12 months
* Known contraindication to exercise testing
Exploring the Role of At-home Semi-Quantitative Pregnancy Tests for Medical Abortion Follow-up

This study will examine the feasibility, acceptability and usability of a semi-quantitative urine pregnancy test (dBest One Step hCG Panel Test Kit) for at-home follow-up after early medical abortion using mifepristone+misoprostol. The study seeks to:

1. Assess the feasibility of using this test in lieu of standard one-week clinic-based follow up for determination of complete abortion status as part of normal service delivery. In Mexico, follow up will be in two weeks, as is standard care in that .
2. To determine if women using this test at home understand how to use it and can correctly interpret the results; is it practical.
3. Assess women's and provider's acceptability of using at-home pregnancy tests in lieu of clinic-based follow up for confirmation of complete medical abortion in the future.


Eligibility Criteria:
Inclusion Criteria:

* Women age greater than or equal to 18 years
* Gestational age less than or equal to 63 days by last menstrual period (LMP), ultrasound or clinical assessment
* Agrees to return for follow-up visit and willing to provide an address and/or telephone number for purposes of follow-up
* Able to consent to study participation.

Inclusion Criteria for Mexico:

* Gestational age \<_ 70 days from LMP
* Eligible for mifepristone- misoprostol medical abortion according to clinic guidelines
* Willing to follow instructions of the provider regarding use of the at-home pregnancy test
* Agrees to provide test results by phone to study coordinator on morning of schedule follow-up visit
* Willing to provide an address and/or telephone number for purposes of follow-up
* Agrees to return for standard follow-up visit
* Wishes to participate in the study
* Having easy access to a telephone and transportation
* Able to consent to study participation

Exclusion Criteria:

* Women less than 18 years of age
* Women not eligible for medical abortion services
* Women unable to provide contact information
* Women unable to sign the consent form

Exclusion Criteria for Mexico:

* Women not eligible for medical abortion services
* Women unable to provide contact information
* Women unable to sign the consent form
Balanced Propofol Sedation Versus Propofol Alone Sedation in Therapeutic Endoscopic Retrograde Cholangiopancreatography (ERCP)

Based on previous results, the investigators considered that sedation quality, complications, and procedure outcomes may not be different, however, propofol alone titration may have a fast recovery time than BPS and cost-effectiveness than balanced propofol sedation (BPS). In present study, the investigators therefore evaluate the time and sedation quality of patient recovery, cost-effectiveness, complication, and procedure outcomes between propofol alone and BPS in therapeutic endoscopic retrograde cholangiopancreatography (ERCP).

Previous studies have shown that propofol is superior to traditional sedation regimens with benzodiazepines plus opioids in ERCP procedures. Propofol is a potent hypnotic drug with a short duration of action and consequently a more rapid recovery time for the patients compared with the available Benzodiazepines. Several prospective studies have shown that balanced propofol sedation (BPS) can be used safely and effectively for diagnostic endoscopy under the direction of a gastroenterologist. BPS which was originally described by Cohen et al, combines small incremental doses of propofol with single induction doses of benzodiazepines and opioids under the direction of a physician that is not an anesthesiologist. Because BPS usually targets moderate sedation, adequate amnesia and analgesia can be achieved with concomitant administration of benzodiazepines and opioids. It may cause synergism between propofol and midazolam and reduce dose of propofol. However, there was no proven benefit between propofol alone titrated to moderate level of sedation and BPS; propofol titration combination with benzodiazepines and fentanyl.

Eligibility Criteria:
Inclusion Criteria:

* candidates for therapeutic ERCP

Exclusion Criteria:

* patient age \< 18 years
* pregnant women
* inability to provide informed consent
* patients with total gastrectomy
* American Society of Anesthesiologist (ASA) Class V patients
* patients with known respiratory disease, patients with neurologic impairment
* patients with known allergy to the drugs used, history of complications with previous sedation
High Dose Chemotherapy and Autologous Transplant for Neuroblastoma

This is a standard of care document, outlining the therapy for children with high risk neuroblastoma who are not eligible for Children's Oncology Group (COG) studies.

This therapy involves the use of melphalan, etoposide, and carboplatin (consolidation chemotherapy); autologous stem cell rescue, post-transplant radiation therapy and a maintenance phase with Isotretinoin (Accutane, 13-cis-retinoic acid) therapy. If available, patients should also consider post-transplant therapy with cytokines and monoclonal antibody (ch14.18) on a COG or New Approaches to Neuroblastoma Therapy (NANT) trial.

Eligibility Criteria:
Inclusion Criteria:

* Less than 30 years of age at diagnosis of neuroblastoma
* No evidence of disease progression: defined as increase in tumor size of \>25% or new lesions
* Recovery from last induction course of chemotherapy (absolute neutrophil count \> 500 and platelet \> 20,000)
* No uncontrolled infection
* Minimum frozen peripheral blood stem cells (PBSCs) of 2 x 10\^6 CD34 cells/kg for transplant are mandatory and 2 x 10\^6 CD34 cells/kg for back-up are strongly recommended (thus, PBSC of 4 x 106 CD34 cells/kg is encouraged)
* Adequate organ function defined as:

  * Hepatic: aspartate aminotransferase (AST) \< 3 x upper limit of institutional normal 8 Cardiac: shortening fraction ≥ 27% or ejection fraction ≥ 50%, no clinical congestive heart failure 8 Renal: Creatinine clearance or glomerular filtration rate (GFR) \> 60 mL/min/1.73m\^2 If a creatinine clearance is performed at end induction and the result is \< 100 ml/min/1.73m\^2, a GFR must then be performed using a nuclear blood sampling method or iothalamate clearance method. Camera method is NOT allowed as measure of GFR prior to or during Consolidation therapy for patients with GFR or creatinine clearance of \< 100 ml/min/1.73m\^2

Exclusion Criteria

* Patients with progressive disease should consider participating in phase I studies since consolidation therapy using the regimen outlined in this document have not been determined to be useful.
* Patients who are delayed in consolidation chemotherapy beyond 8 weeks, and don't meet organ function criteria.
A Pilot Study of Working Women and Breast Cancer

The purpose of this research is to better understand the relationship between employment and breast cancer. Research is being conducted to understand how workplace factors influence breast cancer patients' ability to adhere to recommended cancer treatment and effectively recover from cancer. Investigators hope to use the findings from the study to help working breast cancer survivors make informed decisions about treatment and employment in collaboration with their employers and healthcare providers.

Patients enrolled will be interviewed three times over a six month period. They will be asked questions about their experiences in managing their cancer while taking care of their job responsibilities. Patients will be asked to complete a survey that asks questions about their breast cancer treatment, their job, and how they manage their responsibilities while undergoing cancer treatment.

The first initial meeting will be conducted at a time and location that is convenient for the patient. This meeting should last about an hour to an hour and a half.

Three and six months after the initial interview, study participants will be asked to complete a follow-up survey by either telephone or Internet/Web, depending on their preference. These telephone surveys will last between 15-30 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Women age 18-65
* Working at least 20 hours per week
* Currently patients of the University of Kentucky Markey Cancer Center
* Are able to read, write, and communicate in English
* Have reliable telephone or Internet/Web access in or outside the home

Exclusion Criteria:

* Self-employed
* Unemployed
* Cognitively impaired