cyrilzakka/clinical-trials huggingface dataset:
Effects of the Use of "de Novo" Everolimus in Renal Tranplant Population

This is an open, randomized, single-center study. The selected patients will be first divided into two major groups according to the type of organ to be transplanted: standard criteria donor (SCD) or extended criteria (ECD) kidney. Then, each group will be randomly allocated to one of the treatments: tacrolimus (TAC) or everolimus (EVL).

All patients received induction therapy with basiliximab (BXB) and maintenance with Mycophenolate Sodium (MYF) and prednisone (P). This study will evaluate as Primary objectives: To characterize the molecular profile of cytokines in kidneys obtained from deceased donors such as "standard" (SCD) and extended criteria (ECD) in biopsies taken before and after transplantation and to evaluate the effect of treatment with everolimus (EVL) in the expression of these molecules. And as Secondaries objectives: To correlate the pattern of cytokines with delayed graft function (DGF), cold ischemia time, episodes of acute rejection and patient and graft survival.

A total of 80 patients will participate in the study, being distributed into 4 groups of 20 individuals. In a pilot study to assess the interventional effect of the mmediate use of EVL on the cytokine profile of ECD and SCD kidneys, compared to conventional immunosuppressive therapy with TAC, no statistical power analysis could be performed a priori.

Definitions of Extended Criteria Donor and Delayed Graft Function (DGF) Deceased donors aged ≥ 60 years or aged between 50 and 59 years and with at least two of the following risk factors: history of systemic hypertension terminal creatinine levels \> 1.5 mg/dL or death by a cerebrovascular accident.

DGF (delayed graft function) is defined as the need for dialysis in the first 7 days after transplantation.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years (black and white subjects);
* End-stage renal disease with indication for transplantation (primary deceased-donor kidney transplant)
* "Standard" traditional (SCD) or extended criteria (ECD) donor;
* Informed consent form duly signed before SCD or ECD kidney transplantation.

Exclusion criteria:

* The subject, in the opinion of the investigator, is not able to complete the study protocol;
* Recipient of live-donor kidney graft;
* Multiple organ transplant recipient;
* Evidence of large systemic or localized infection;
* Evidence of infiltration, cavitation or consolidation on chest X-rays obtained during the evaluation in the screening / baseline visit;
* Use of any drug under investigation or treatment until up to 4 weeks before transplantation;
* Known or suspected hypersensitivity to tacrolimus, everolimus or mycophenolate sodium;
* Immunosuppressive therapies in addition to those described for this study;
* Hypersensitized patients (PRA \> 30%);
* Patients with HIV+ or Hepatitis B or C virus infection.
* Patients for whom T0 and T15 biopsies were not taken.
Adherence to Preventive Care for Cervical Cancer

In the United States, the highest incidence of cervical cancer occurs in inner city urban centers, rural areas, the deep South, Appalachia and the U.S.-Mexico border. The goal of this study is to study predictors of adherence among patients seeking care at an inner city medical center in New York City and the U.S. Mexico border for cervical cancer prevention, namely, Pap smears and colposcopy exams.

Because there are multiple pathways through which a person is influenced to seek and receive care, the investigators will conduct interviews with patients seeking care for cervical cancer prevention at an inner city medical center. The investigators will ask questions related to previous screening, diagnostic, and treatment practices as well as barriers experienced in seeking such care. The investigators will also explore patients' level of resiliency and coping as predictors of adherence to timely care. Furthermore, among immigrants, questions about acculturation and discrimination will be asked. Additional measures of socioeconomic status, such as education, income and occupation will also be collected.

Eligibility Criteria:
Inclusion Criteria:

* women who are at least 21 years old
* are seeking care for a Pap smear exam
* are seeking care for a colposcopy exam for the first time
* are not pregnant by self-report
* are able to provide informed consent

Exclusion Criteria:

* women who do not meet the above eligibility criteria
* women who have no prior history of a hysterectomy
* women who have previously participated in this study
Multivirus-specific T Cells in the Treatment of Refractory CMV and/or EBV Infection After Allo-HSCT

To evaluate the safety and tolerability of partial HLA-matched VSTs against both CMV and EBV viruses in recipients of allogeneic hematopoietic stem cells with refractory viral infections (CMV and/or EBV).

Preliminary evaluation of the efficacy of partial HLA-matched VSTs against both CMV and EBV viruses in recipients of allogeneic hematopoietic stem cells with refractory viral infections (CMV and/or EBV); To monitor the duration and expansion of multi-virus VSTs cells after infusion.

This study consists of two parts: (1) The first stage is the safety evaluation of multi-virus VSTs and the exploration of DLT and MTD; (2) The second phase is to evaluate the safety and efficacy of multi-viral VSTs in selecting appropriate doses in the first phase.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years old, and less than or equal to 70 years old, gender is not limited.
* Prior myeloablative or non-myeloablative allogeneic hematopoietic stem cell transplantation.
* Persistent infection with CMV and/or EBV persists despite standard treatment .
* Prednisone or its equivalent hormone is less than or equal to 0.5 mg/kg/ day when enrolled.
* ECOG score ≤3, expected survival greater than 3 months.
* End blood oxygen saturation ≥90% on room air.
* Available multi-virus-specific cytotoxic T lymphocytes.
* Negative pregnancy test in female patients if applicable.
* Written informed consent and/or signed assent line from patient, parent or guardian.

Exclusion Criteria:

* Within 28 days after allogeneic hematopoietic stem cell transplantation.
* Active III-IV acute GVHD, and/or moderate and above chronic GVHD.
* Severe organ dysfunction: Heart: New York Heart Association (NYHA) levels III and IV; Liver: Total bilirubin\>34umol/l; ALT, AST\>2 times the normal upper limit; Kidney: Blood creatinine \>130umol/L; Lung: Type I or II respiratory failure; Brain: unconsciousness, intracranial hypertension.
* Received DLI, other CTL, CAR-T, NK and other cell therapies, T cell monoclonal antibody immunosuppressants, or participated in any other clinical research related to drugs and medical devices within 28 days before enrollment.
* Poor compliance, and subjects deemed unsuitable for study participation by the investigator.
Clinical Study of Umbilical Cord Mesenchymal Stem Cells (UC-MSC) for Treatment of Knee Osteoarthritis

Osteoarthritis (OA) is one of the most common joint diseases that is considered a chronic degenerative disorder. There is no effective therapy available today. This prospective clinical trial is designed in an attempt to study the efficacy of mesenchymal stem cells with platelet rich plasma in knee osteoarthritis.


Eligibility Criteria:
Inclusion Criteria:

* 30-70 years old.
* No serious infection, chronic diseases, diabetes and tuberculosis.
* Osteoarthritis of the knee with grade1-3 defined by the modified Kellgren-Lawrence classification.
* Written informed consents were obtained from all subjects.

Exclusion Criteria:

* Pregnant women or cognitively impaired adults.
* Inflammatory or post infectious arthritis.
* Intra-articular drug injection within the previous 2 months.
* Serious medical illness with a life expectancy of less than 1 year.
* Prior admission for substance abuse.
* Arthroscopy during the previous 6 months.
* Systemic autoimmune rheumatic disease.
* Poorly controlled diabetes mellitus.
* Immunosuppressive or anticoagulant treatments.
* Treatment with corticosteroids in the 3 months prior to inclusion in the study.
* NSAID therapy within 15 days prior to inclusion in the study.
Clinical Evaluation of the FluidVision Accommodating Intraocular Lens (AIOL)

The purpose of this study is to evaluate the safety and effectiveness of an investigational IOL.

Eligible subjects will receive the investigational IOL in one eye and be followed at 1 day, 1 week, 1 month, 3 months, 6 months, 12 months, 18 months, 24 months and 36 months post-operation.

Eligibility Criteria:
Key Inclusion Criteria:

* Eligible for primary intraocular lens implantation for the correction of aphakia following cataract extraction;
* Best corrected distance visual acuity worse than 20/40 either with or without a glare source present (e.g. Brightness Acuity Tester);
* Less than or equal to 1.0 diopter (D) of preoperative keratometric astigmatism;
* Willing and able to comply with schedule for follow-up visits for 36 months after surgery.
* Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

* Systemic disease that could increase the operative risk or confound the outcome (e.g. autoimmune disease, diabetes);
* Taking systemic medications that may confound the outcome or increase the risk to the subject;
* Ocular conditions that may predispose for future complications;
* Previous intraocular or corneal surgery that might confound the outcome of the investigation or increase the risk to the subject;
* Pregnant, lactating during the course of the investigation, or with another condition associated with fluctuation of hormones that could lead to refractive changes;
* Diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal disorders) that are predicted to cause future best corrected visual acuity loss worse than 20/40.
* Other protocol-defined exclusion criteria may apply.
Umbilical Cord Milking on the Reduction of Red Blood Cell Transfusion Rates in Infants

Delayed cord clamp of at least 30 seconds in neonates under 37 weeks has shown that these infants have higher circulating blood volume in the first 24 hours, less need for blood transfusions, and less incidence of intraventricular hemorrhage. Delayed umbilical cord clamping has also been shown to increase the initial hematocrit and decrease the need for red blood cell (RBC) transfusions compared with no intervention in infants born between 27 and 33 weeks' gestation. However, a delay in cord clamping of 30-45 seconds may theoretically interfere with neonatal resuscitation. There have been few studies that addressed the active milking of the cord and its effect on neonatal resuscitation. Active milking of the umbilical cord towards the baby prior to clamping (rather than passive) should take less than 5 seconds to perform and should not interfere with neonatal resuscitation. Umbilical cord milking, as an alternative to delayed cord clamping, has been shown to increase the circulatory blood volume expressed as the hemoglobin value. Active milking of the cord prior to clamping, however, is not considered standard of care and only 1 Japanese randomized control study has reported that umbilical cord milking reduces the need for RBC transfusions, thus reducing the number of infants requiring a RBC transfusion as compared with control conditions. Our study aims to test the hypothesis that active milking of the umbilical cord will reduce the need for transfusion in preterm infants.

The proposed design is a randomized controlled trial. Pregnant women at risk for delivering a singleton preterm infant between 24 and 28 weeks gestation will be randomized prior to delivery into one of two treatment arms. Common reasons for needing to be delivered at this early gestational age include but are not limited to: preterm labor not responding to tocolytic medications, incompetent cervix with cervical dilation and no contractions, clinical chorioamnionitis requiring delivery for maternal/fetal benefit, severe preeclampsia, severe growth restriction with a non-reassuring fetal heart rate tracing. The first arm will include active milking of the umbilical cord toward the neonate's umbilicus prior to cord clamping at delivery while the second arm will not include this intervention and will have their respective cord immediately clamped in the usual fashion post delivery (control).

Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancy
* Delivery anticipated between 24 and 28+6 weeks gestation
* There is enough time from admission to anticipated delivery to properly obtain consent from the patient

Exclusion Criteria:

* Multifetal gestation
* Antenatally diagnosed major congenital anomaly
* Known Rh sensitized pregnancy
* Hydrops fetalis (any etiology)
* Known positive maternal Parvovirus titers
* Elevated peak systolic velocity of the fetal Middle Cerebral Artery (MCA)
* Clinical suspicion of placental abruption at delivery due to excessive maternal bleeding or uterine hypertonicity
* Maternal age under 18
Detecting the Rest Tremor Associated With Parkinson's Disease Using Analysis of the Muscle Contractions Rhythmicity

Resting tremors associated with Parkinson's disease (PD) remains difficult to quantify and track during disease progression. This study propose to explore the rhythmicity of distal muscle contractions in the upper limb to characterize resting tremor and discriminate it from cerebellar tremor (CT) based on the frequency spectrum of the EMG signal.

This retrospective study analyzed surface EMG recordings of wrist flexor-pronators and extensor-supinators from patients with PD or CT bilaterally in five 10-second conditions: rest with contralateral motor distraction, symmetrical arms extended forward posture with hands pronated, semi-pronation, supination, and elbows flexed with hands pronated. The rhythmicity index (RI) is calculated from the ratio of the area of the maximum power peak to the total area of the spectrum between 1.5-12Hz.

Eligibility Criteria:
Inclusion Criteria:

* patient who performed surface EMG recordings of wrist flexor-pronators and extensor-supinators in Laboratories;
* diagnosis of Parkinson's disease or cerebellar tremor.

Exclusion Criteria:

* Botulinium toxin injection in upper limb during a delay of 3 months before surface EMG recordings;
* Levodopa drugs administrated during a delay of 12 hours before surface EMG recordings;
* Tremor-favour drugs administrated during a delay of 30 days before surface EMG recordings;
* Presence of an other neurologic disease or of any disease associated with motor disorders in upper limb.
Prevention of Childhood Maltreatment in Families With Young Children

This study will examine the efficacy of Enhanced First Connections, which is a short-term perinatal home visiting program that includes infant and early childhood mental health consultation. Mothers with a history of adversity or trauma will be the focus of this research. Hypothesized outcomes of Enhanced First Connections include the prevention of child maltreatment (child abuse and neglect), prevention of child exposure to adult intimate partner violence, increases in family engagement in longer-term evidence based home visiting programs, increases in family engagement in specialized support services to address maternal adversity and trauma, reductions in maternal risk factors, and the promotion of positive parenting and the parent-child relationship.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant women
* Recruited in the second or third trimester of pregnancy
* At least one self-reported experience of adversity or trauma
* English or Spanish speaking

Exclusion Criteria:

- Does not meet all inclusion criteria above
Acute STROke Complicating TAVI - Management and Outcomes

Periprocedural complications of trans catheter aortic valve implantation, and particularly the occurrence of stroke has a marked impact on survival and quality of life. The characteristics of periprocedural stroke complicating TAVI, and particularly of interventions aimed to treat stroke complicating TAVI have not been systematically described. We therefore aimed is to explore the incidence and characteristics of acute stroke complicating TAVI and to describe the safety and efficacy of emergent interventions to treat acute stroke complicating TAVI.


Eligibility Criteria:
Inclusion Criteria:

* patients who have had a stroke within 30 days of TAVI

Exclusion Criteria:

* none
NIPPV vs.nCPAP During LISA Procedure

The goal of this randomized controlled study is to compare the efficacy of using NIPPV versus NCPAP during the LISA procedure in very preterm infants.

The main question it aims to answer is:

• Does NIPPV during the LISA procedure decrease the need for a second dose of surfactant or the need of mechanical ventilation during the first 72 hours of life in comparison with NCPAP? Infants with gestational age between 25+0 and 31+6 weeks of gestation with RDS who do not require VM and treated with NCPAP and FiO2 \>0.30 within the first 6 hours of life who received the first dose of caffeine will be eligible for enrollment in the study Participants will be randomized to receive surfactant with conventional LISA procedure, i.e. performed during NCPAP, or with LISA procedure performed during NIPPV.


Eligibility Criteria:
Inclusion Criteria:

* -Infants with gestational age between 25+0 and 31+6 gestational weeks,
* -RDS which does not require MV
* -Treatment with NCPAP and FiO2 \>0.30 within the first 6 hours of life,
* -First dose of caffeine administered

Exclusion Criteria:

* -absence of informed consent,
* -major congenital malformations,
* -hydrops fetalis,
* -chromosomal diseases,
* -previous treatment with surfactant,
* -cardiorespiratory instability requiring treatment with vasoactive drugs,
* -pneumothorax,
* -death within 72 hours of life.
The Effect of Pain Education on Multidisciplinary Healthcare Students' Understanding of Chronic Pain

Chronic pain is the leading cause of disability worldwide affecting just under 28 million people in the UK. Chronic pain conditions require a biopsychosocial rather than a biomedical model of care. Biomedical management lacks evidence of effectiveness but also has the potential to exacerbate the condition by raising fears and anxiety about potential pathological abnormalities.

Healthcare professionals often hold negative beliefs about people with chronic pain and view the condition within a biomedical framework. These negative attitudes can be observed at the pre-registration training stage of the health professionals' career. Thus, the pre-registration phase is an important point where an individual's understanding of, and beliefs about, pain and people with pain may be shaped for the future. The need for improved and better education of healthcare professionals to support best practice for low back pain with the aim of integrating professionals' management of low back pain and fostering innovation in practice is well recognised. This study seeks to quantify the benefits of pain education in knowledge, attitudes and beliefs. The findings may encourage other pre-registration institutions to deliver pain education in a more directed way and simultaneously support the International Association for the Study of Pain's (IASP) proposed integration pain education into existing curriculum.

In 2011 Briggs et al described pain education at undergraduate level for healthcare professionals as 'woefully inadequate'. Pain Neurophysiology Education (PNE) can improve undergraduates' pain understanding/management, however previous RCTs used single discipline groups and immediate follow-up. Investigation of the effectiveness of this education on students across the multi-professional team with medium-to-long-term follow-up will provide important new information on the generalisability of existing data and whether or not any changes in pain understanding/management are maintained over time.

This study aims to contribute to the development of neuromusculoskeletal physiotherapy by identifying whether or not this education, which aims to up skill healthcare professionals of the future, is effective and can change their behaviours in practice to enhance patient care in chronic pain management. PNE has been shown to be useful in patient care in conjunction with other treatment methods. If this intervention is successful in altering pain attitudes and knowledge in keeping with modern science then students may feel more confident and able to manage pain post qualification. The findings of this study will support or refute the addition of PNE into healthcare professional undergraduate programmes.

Eligibility Criteria:
Inclusion Criteria: No previous pain education

* Pre-registration student at Teesside University in one of following six disciplines: paramedics, occupational therapists, physiotherapists, midwifery, nursing, diagnostic radiography.

Exclusion Criteria: In depth previous pain education

* Disciplines other than those listed above
Two Different Types of Luteal Phase Support in Natural Cycle Frozen Embryo Transfer and Its Effect on Pregnancy Rates

The aim of the study is to compare the pregnancy rate between women treated with Gonadotropin Releasing Hormone (GnRH) agonist together with Human Chorionic Gonadotropin (HCG) and standard luteal support with progesterone following transfer of frozen embryos in in-vitro-fertilization (IVF) natural cycles.

The rate of frozen embryos transfer (FET) has increased in recent years due to a higher tendency of single embryo transfer, use of preimplantation genetic testing, and prevention of ovarian hyperstimulation.

There are different methods to prepare the endometrium for FET:

1. Natural cycle (NC) - natural preparation of the body for implantation without the need for medicinal intervention.
2. Modified natural cycle (mNC) - Inducing ovulation by administration of Human Chorionic Gonadotropin (HCG) trigger.
3. Medical - preparation of endometrium with hormones (estrogen and progesterone).

Following embryo transfer, luteal phase support should be considered. Administration of treatment depends on the type of cycle chosen (either natural or medicated). Treatment options include progesterone, HCG and Gonadotropin Releasing Hormone (GnRH) analog - either one of them or combined. Different protocols (dosages and duration of use) with different pregnancy outcomes were explore before with inconclusive results. We wish to investigate administration of GnRH agonist+HCG vs. progesterone.

Patients included in the study will be women undergoing natural cycle FET at the IVF center in Shaare Zedek, Jerusalem, Israel. All patients will be randomly divided into two groups, each will receive a different luteal treatment support as will be detailed later. Patients demographic data and pregnancy outcomes will be collected.

Based on the clinical pregnancy rate in the prospective study by Bjuresten, et al \[Fertil Steril, 2011\], where a clinical pregnancy rate of 32% was found among women treated with progesterone for luteal support, and given an alpha of 5% and a power of 80%, 144 women (72 women in each group) are required in order to demonstrate a clinical pregnancy rate of 55% in the study group.

Comparison of categorical variables will be carried out using the the chi-squared test. Comparison of continuous variables will be performed using the Students t-Test or Mann-Whitney U method depending on the variable distribution (normal vs. non-normal distribution, respectively). A multivariate regression will also be conducted in order to determine which variables are significantly and independently related. Statistical significance will be defined when P values are less than 0.05

Eligibility Criteria:
Inclusion Criteria:

* Normo-ovulatory women
* Women undergoing frozen embryos transfer in a natural cycle
* Age 18-45
* BMI 18-35

Exclusion Criteria:

* Women undergoing medicated frozen embryos transfer
* Women with a BMI over 35 or under 18.
* Women with hydrosalpinges
* Women with defects or uterine malformations (congenital) or acquired such as myomas
* Egg donation and surrogacy
* Use of preimplantation genetic testing