cyrilzakka/clinical-trials huggingface dataset:
Clinical Study Of Affinity Versus SOC In The Management Of VLUs

This prospective, multi-center, randomized, controlled clinical study compares Affinity® plus SOC to SOC alone in subjects with VLUs. Affinity® will be used along with standard of care on venous leg ulcers (VLUs) of greater than 4 weeks which have not adequately responded to conventional ulcer therapy.

Two hundred (200) subjects with a chronic VLU ranging in size from 2cm2 and 80 cm2 will be randomized 1:1 to either Affinity® and SOC or SOC alone following the 28 day screening period. Following screening and randomization, subjects shall be seen weekly for up to 24 weeks. For subjects that heal prior to week 24, a healing confirmation visit shall occur two weeks later to confirm maintenance of complete wound closure.

Subjects that are randomized into the SOC group whose VLU has not healed by week 12 may be crossed over to receive Affinity® and followed for an additional 12-14 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Ulcers of venous origin, as clinically determined by clinical signs and symptoms (e.g. hyperpigmentation of the surrounding skin, history of swelling, varicosities, lipodermatosclerosis and/or dermatitis) or other assessments (e.g. venous reflux test).
2. Venous insufficiency ulcers, of at least 1-month duration, which have not adequately responded to conventional ulcer therapy
3. Venous insufficiency ulcers between 2 cm2 and 80 cm2
4. Partial- or full-thickness VLU, including ulcers with tissue damage that extends through the epidermis and into the upper epidermis (papillary dermis), or into the deep dermis (reticular dermis) but not through muscle, tendon, capsule, or into bone.
5. Subjects are between 18 and 85 years of age.
6. IRB approved Informed Consent Form is signed before screening and treatment.
7. Subject is expected to be available for 24 week follow-up
8. Females of child-bearing potential must be practicing an acceptable means of birth control as determined by the investigator.
9. Subjects with bilateral ulcers may be enrolled.

Exclusion Criteria:

1. Ankle Brachial Index (ABI) of \<0.65
2. Venous insufficiency ulcers less than 2cm2 or greater than 80cm2
3. Vasculitis, severe rheumatoid arthritis, and other collagen vascular diseases
4. Clinically significant medical conditions which would impair wound healing, as determined by the investigator, including renal, hepatic, hematologic, neurologic or immune disease
5. Signs and symptoms of infection, cellulitis, osteomyelitis
6. Necrotic or avascular ulcer beds
7. Ulcer with exposed bone, tendon or fascia
8. Subjects receiving hemodialysis or have uncontrolled diabetes
9. Subjects who are currently receiving or have received at any time within one month prior to entry into the study, corticosteroids (\>15 mg/day), immunosuppressive agents, radiation therapy, or chemotherapy. Anticipated use of the above agents will exclude subjects from entry into the study.
10. Subjects enrolled in other wound drug investigational studies within the past three months, or device studies within the past 30 days.
11. Subject is pregnant or breast feeding.
Discarded Materials Study

Use of discarded embryos to advance laboratory expertise and technology in the area of human embryo development and assisted reproductive technologies

1- Testing methods or freezing before implementing techniques. 2- Develop cell surgery and micromanipulation techniques. 3- Develop methods to optimize the determinations of genes and chromosomes 4- Quality-assess laboratory equipment. 5- Test proficiency of laboratory staff. 6- Analyze what effects the early development of embryos. 7- Develop new methods and media to allow for higher survival rates of embryos. 8- Develop non-invasive tests for predicting embryo quality to predict IVF success.

Eligibility Criteria:
Inclusion Criteria:

none

Exclusion Criteria:

none
Rheoparin-coated Tubing System for Minimized Extracorporeal Circulation (MECC)

In this study, the investigators would like to compare a heparin-coated tubing system for minimized extracorporeal circulation (MECC) with the conventional tubing system for MECC, which does not contain heparin coating. The MECC system has been used since 14 years in the investigators' hospital as an extracorporeal system to support circulation and provide oxygen to the tissues during coronary artery bypass grafting. Until today, the investigators performed more than 5000 MECC procedures in their department.

Background

The investigators would like to investigate a new composition of their MECC system in patients receiving coronary artery bypass surgery. Normally, the MECC system induces complement system activation and coagulation cascade, which could have a negative impact on postoperative outcome. A tubing system containing heparin (rheoparin) could contribute to a better biocompatibility in terms of a diminished activation of inflammatory reactions and a reduction of cerebral embolic load, which is a regular issue during extracorporeal circulation due to formation of solid and gaseous microemboli in the tubing system.

Objective

The aim is to investigate biocompatibility (coagulation, inflammation) and influence on cerebral embolic load of the rheoparin-coated MECC system and to compare the results with the current MECC system containing a rheoparin-free tubing system.

Methods

Patients undergoing elective coronary artery surgery are randomized to receive extracorporeal circulation using the MECC system with or without rheoparin coating. All procedures are performed according to the institutional standards.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Elective cardiac surgery
* Coronary artery bypass grafting

Exclusion Criteria

* Re do
* Usage of antiplatelets, antithrombotic drugs
* Coagulopathy
* Persistent foramen ovale
* Infection
* Heparin-induced thrombocytopenia (HIT)
Lymph Node Mapping Via Flourescent Dye in Colon Cancer

The aim of the study is to evaluate whether lymph nodes draining the region of the carcinoma are located only inside the lines of standard resection or in some percentages are located outside as well. The visualized nodes draining the region of the carcinoma will be correlated to location, fluorescent yes/no and nodal positive/negative.

The draining lymph nodes will be visualized using the fluorescent dye indocyanine green.

The aim of the study is to evaluate whether lymph nodes draining the region of the carcinoma are located only inside the lines of standard resection or in some percentages are located outside as well. The visualized nodes draining the region of the carcinoma will be correlated to location, fluorescent yes/no and nodal positive/negative.

The draining lymph nodes will be visualized using the fluorescent dye indocyanine green.

Participants with a diagnosed (andeno)carcinoma of the ascending, transverse, descending and sigmoid colon will be included. Preoperatively the participants will receive an indocyanine green(ICG) injection at four points around the tumour endoscopically. The ICG marking will take place one to five days prior to surgery. In the draining lymph nodes of the specific region the ICG will accumulate and thus visible via fluorescence-camera during the surgery.

Intraoperatively, the precise locations of all fluorescent nodes will be documented photographically. A standard resection and lymph node dissection will be conducted, potential fluorescent nodes outside the standard resection lines will additionally be resected. The fresh specimen will then be measured, the fluorescent nodes marked and after the pathologic examination the nodes will be correlated to location, fluorescent yes/no and nodal positive/negative.

The aim ist not the visualization of the Sentinel node or the directly draining lymphatic vessel but all the nodes draining the peritumorous region at the point of surgery.

Eligibility Criteria:
Inclusion Criteria:

* histologically diagnosed carcinoma of the ascending, transverse, descending or sigmoid colon.

Exclusion Criteria:

* not wanting to participate
* other carcinoma then adenocarcinoma
* endoscopic marking not possible
Paliperidone Palmitate Effectiveness Assessment Registry - Longitudinal (PEARL)

The primary objective of this study is to determine if Australian patients with schizophrenia treated with paliperidone palmitate under conditions of continuous monitoring of outcomes over a 12-month period achieve relapse rates comparable to published literature.

This study involves the establishment of PEARL, an Australian Quality Use of Medicine clinical registry designed to collect clinical and social data on up to 300 patients with schizophrenia for a 12-month period after initiating treatment with intramuscular (IM) injections of paliperidone palmitate as part of their routine clinical care. Continuous feedback of clinical outcomes will be via regular reports to all registry sites. Enrollment in PEARL should be considered only after the clinical decision to prescribe IM paliperidone palmitate has already been made because the treating physician has determined that this treatment is the best option for the patient. Observational Study - No investigational drug administered

Eligibility Criteria:
Inclusion Criteria:

* Must fulfill the diagnostic criteria for Schizophrenia Disorders as defined by Diagnostic and Statistical Manual of Mental Disorders Version IV (DSM-IV)
* Must meet the approved Therapeutic Goods Administration (TGA) indication for injectable paliperidone palmitate
* Must have provided written informed consent indicating that they understand the purpose of and procedures required for the registry and are willing to participate in the registry.

Exclusion Criteria:

* Those with a known hypersensitivity to either paliperidone or risperidone, or to any excipients in the paliperidone palmitate formulation
* Employees of the clinician or study centre, with direct involvement in the proposed registry or other studies under the direction of that clinician or study centre, as well as family members of the employees or the clinician.
One-piece and Two-piece Zirconia Abutments in Single Implant Crowns in Esthetic Region

The goal of this clinical trail is to evaluate the clinical, radiological and immunological outcomes of the one-piece zirconia abutments (OPZAs) and two-piece zirconia abutments (TPZAs) with friction-fitted titanium bases in single implant crowns in aesthetic region. The main question it aims to answer is:

whether the mechanical properties of one-piece zirconia abutments are the same as those of two-piece zirconia abutments.

Participants who have two missing teeth in aesthetic region will receive the OPZAs for one restoration and the TPZAs for the other.

Researchers will compare OPZAs group (OG) and TPZAs group (TG) to see the clinical, radiological and immunological outcomes of the two.

Objective: To evaluate the clinical, radiological and immunological outcomes of the one-piece zirconia abutments (OPZAs) and two-piece zirconia abutments (TPZAs) with friction-fitted titanium bases in single implant crowns in aesthetic region.

Materials and methods: The study is a single center, split-mouth and randomized controlled clinical trial. Eligible sites of patients will be randomly assigned into two groups: OPZAs group (OG) and TPZAs group (TG). Survival rates, mechanical complication rates, bleeding on probing (BOP%), probing depth (PD), modified plaque index (mPI), marginal bone loss (MBL), concentrations of pro-inflammatory cytokines (TNF-α, IL-6) in peri-implant crevicular fluid (PICF), and pink esthetics score/white esthetics score (PES/ WES) will be evaluated.

Discussion: Results of the present study will help to evaluate the clinical, radiological and immunological outcomes of OPZAs and TPZAs with friction-fitted titanium bases in single implant crowns in aesthetic region and provide evidence for the effects of two types abutments on the health of peri-implant soft and hard tissue.

Eligibility Criteria:
Inclusion Criteria:

1. age≥18;
2. patients with two missing teeth in esthetic region and plan to be restored with two single implant crowns;
3. adjacent to natural teeth;
4. absence of oral mucosal disease and oral infection;
5. implants with conical connection (Nobel Active, Nobel Biocare® or NobelReplace Conical Connection, Nobel Biocare®);
6. patients with the willingness to participate in the present study.

Exclusion Criteria:

1. heavy smokers (\>10 cigarettes/day);
2. uncontrolled periodontitis (Full mouth plaque score\>20%, full mouth bleeding score\>25%, residual pocket depth\>5mm);
3. with systematic diseases that may affect implant therapy, such as uncontrolled diabetes mellitus (Fasting blood-glucose\>7.2mmol/L, Glycosylated hemoglobin \>7%), current intake of bisphosphonates (treatment for malignancy), pregnant(or plan to get pregnant), with history of radiation therapy in head and neck region.
Impact of Blood Salvage Therapy on Outcomes After Oncologic Liver Surgery

A before and after trial comparing the systematic use of blood salvage therapy with leucocyte filter during oncologic liver resections. Recurrence, survival, allogenic transfusion rates and surgical outcomes are compared with a representative historic cohort.

Blood salvage therapy in oncologic liver surgery is seldom used based on unproven concerns about the safety of the technique regarding potential cancer dissemination or recurrence. Nevertheless, the technique has proven advantages in other surgical settings regarding the allogenic transfusion outcomes. Allogenic blood transfusion has been scientifically proven to worsen prognosis in oncologic surgery. This study compares a cohort of patients systematically exposed the blood salvage therapy to one comparable cohort without the therapy and outcomes regarding transfusion rates, post-operative Hb measurement, recurrence, overall survival, and post-operative adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Adult Oncologic liver surgery scheduled in our institution

Exclusion Criteria:

* Condition precluding consent for trial Pregnancy
Mechanism and Efficacy of Rehabilitation Approaches

Identify the possible mechanisms and the relative effectiveness of existing rehabilitation approaches that target upper extremity deficits of stroke patients on the ground that these approaches are based on neuroplasticity principles and sound motor control theories.

Comparisons of constraint-induced therapy (CIT) vs. bilateral arm training (BIT)vs. combined therapy were made. Stroke patients will receive one of these three approaches and be evaluated pre- and post-treatment. the treatment will last 3 weeks and 5 days per week. The evaluation will include clinical measures of motor function, ADL, and quality of life, kinematic performance, and activation patterns of cortex.

Eligibility Criteria:
Inclusion Criteria:

* a first-ever clinical cerebrovascular accident patients
* at least 6 months post-stroke onset
* premorbid right-hand dominance
* demonstration of Brunnstrom stage III of the affected upper extremity
* no excessive spasticity in the joints of the affected upper extremity

Exclusion Criteria:

* a score of less than 24 on the Mini Mental State Exam
* poor physical conditions that would interfere with participation
* excessive pain in any joint that might limit participation
Study of the P16 Gene as a Predictor of Myelosuppression in Breast Cancer Patients

The primary purpose of this study is to measure the association between baseline expression of the senescence effector protein p16INK4a and myelosuppression due to chemotherapy in patients with breast cancer. Patients with Stage I-IV breast cancer will be included and myelosuppression will be assessed after the first cycle of chemotherapy via measurement of an absolute neutrophil count (ANC) measured one time between days 7-11 post cycle one. Study subjects will also be asked to complete a brief health behaviors questionnaire to gather information on other relevant variables.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age;
* Histologically confirmed Stage I-IV breast cancer;
* ECOG Performance Status 0-3;
* Scheduled to start a new course of chemotherapy in the neo-adjuvant, adjuvant or metastatic setting for newly diagnosed or recurrent disease;
* Growth factors, e.g., filgrastim, pegfilgrastim, are allowed, but their dose and duration will be tracked.
* Absolute Lymphocyte Count (ALC) \> 500 cells/μL as determined by routine CBC with differential;
* Signed, IRB approved written informed consent.

Exclusion Criteria:

* Presence of acute, active infection;
* History of clonal bone marrow disorder (i.e., myelodysplastic or myeloproliferative disorder, acute or chronic leukemia);
* Other co-morbid illness which would impair ability to participate in the study;
* Concurrent experimental therapy (Note: concurrent biologic therapy IS permitted, provided it is not experimental).
* Prior or current receipt of histone deacetylase (HDAC) inhibitors
Online Programs to Promote Colon Cancer Screening

To evaluate online peer support and colorectal cancer screening behavior among individuals who are not currently meeting colorectal cancer screening guidelines. This is a randomized controlled trial.

Participants in the control group will view standard online information about colon cancer screening. Participants in the intervention group will view the same information and also will be invited to sign on to the online website and interact with peer supporters at their convenience. They will have 6 months to communicate with peer supporters. Peer supporters are encouraged to address comments and concerns of the study participants.

About 300 study participants, majority white, female. Inclusion criteria: age 50-75, not currently meeting colorectal cancer screening guidelines, no previous colorectal cancer.

The study will also include 15 previously identified peer supporters.

Recruitment: Administrators of the SparkPeople.com weight loss community will send study recruitment emails to members at least 50 years of age. Interested individuals will pass an eligibility screening and provide informed consent.

Eligibility Criteria:
Inclusion Criteria:

1. Age 50-75
2. Not currently meeting colorectal cancer screening guidelines
3. No previous colorectal cancer.
Assessment of Self-Confidence of Dental Interns Regarding Provision of Different Pediatric Dentistry Procedures

This study mainly about dental interns testing their knowledge before and after entering the pediatric rotation

A convenient sample will be selected from the dental interns attending the Pediatric Dentistry Department, Cairo University training period. The study will include all the dental interns submitted for training over 12 successive months.

Eligibility Criteria:
Inclusion Criteria:

* Dental interns who got their bachelor's degree from Egyptian governmental and private universities.
* Dental interns who passed the internship period in the pediatric dentistry department.

Exclusion Criteria:

* Dental interns who got their bachelor's degrees from abroad universities.
Evaluation of an Internet Based Education and Support Program for Patients Awaiting Kidney Transplantation

The goal of this study is to test the feasibility study of an internet based education and support program for patients awaiting kidney transplantation. The study is designed as a national pilot randomized controlled trial with a waitlist control group, to test the feasibility, acceptability, and potential effects of the intervention on patients' physical and mental health.

Persons 18 years and older with severe renal failure and accepted on waiting list for kidney transplant with deceased donor in Sweden since at least 6 months will be recruited for participation.

Recruitment will be performed through Sweden's four transplant centers. Exclusion criteria will include not considering themselves able to spend 3-4 hours/week to work in the program. The study will be performed using a study platform which is previously well tested.

The intervention group The intervention is a support an education program, consisting of 9 modules running over 9 weeks. First, an introductory module is given that involves goal setting, followed by two training modules with information; The first on kidney disease, treatment and self-care in severe renal failure and while waiting for kidney transplantation, the second on kidney transplant-specific areas such as drugs, potential complications, lifestyle advice and self-care before and after kidney transplantation. This is followed by three behavioral components spread over five modules/weeks: acceptance (one module), problem solving (one module) and behavioral activation (three modules), and finally a summation module that focuses on consolidating the knowledge learned during the program. Each module consists of texts, illustrations, short films, reminders to practice physical activity and weekly homework for which the people receive feedback from a contact person. Any participants who are transplanted while undergoing the program will be offered to continue the study with adapted modules. Adaptations involve more relevant examples and information regarding drugs, complications and diet which become more relevant after the transplant.

Waitlist control group The control group will be followed with weekly check-ups for 9 weeks via the study platform regarding well-being, whether they have been transplanted or if something happened that affects their life situation. After the intervention period of 9 weeks, the control group will be offered the same program as the intervention group.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* severe renal failure and accepted on waiting list for kidney transplant with deceased donor in Sweden since at least 6 months

Exclusion Criteria:

* Not considering themselves able to spend 3-4 hours/week to work in the program
* Another illness that permanently renders kidney transplantation impossible
Lidocaine Prilocaine Spray in Reducing Pain During Hysterosalpingography in Women With Primary Infertility

We aim to assess the Safety and Efficacy of Cervical Lidocaine Prilocaine Spray in Reducing Pain During Hysterosalpingography in women with primary infertility

We aim to assess the Safety and Efficacy of Cervical Lidocaine Prilocaine Spray in Reducing Pain During Hysterosalpingography in Women with Primary Infertility.

Eligibility Criteria:
Inclusion Criteria:

* Women aged 18-45 years. Diagnosed with primary infertility (no prior pregnancy after at least 12 months of unprotected intercourse) and scheduled for HSG as part of infertility evaluation.

Exclusion Criteria:

* Known allergy or hypersensitivity to lidocaine, prilocaine, or any components of the spray.
* Current pregnancy or suspicion of pregnancy.
* Active pelvic inflammatory disease or history of severe pelvic infections within the last 6 months.
* Use of systemic analgesics, sedatives, or anesthetics within 24 hours prior to the procedure.