cyrilzakka/clinical-trials huggingface dataset:
Study Comparing Two Sirolimus Regimens vs. Tacrolimus and Mycophenolate Mofetil Regimen in Kidney Transplant Recipients

To demonstrate the superiority of SRL + TAC elimination + corticosteroids (Group I) and SRL + MMF + corticosteroids (Group II) to TAC + MMF + corticosteroids (Group III) with respect to renal allograft function at month 12 post-transplantation.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years.
* End-stage renal disease with subjects scheduled to receive a primary or secondary renal allograft from a cadaveric donor, from a living-unrelated mismatched donor, or from a living-related mismatched donor. Unreported HLA values will be considered a match.
* Women of childbearing potential must have a negative serum pregnancy test before administration of assigned treatment and agree to use a medically acceptable method of contraception throughout the treatment period and for 3 months following discontinuation of assigned treatment.

Other inclusions apply.

Exclusion Criteria:

* Evidence of active systemic or localized major infection.
* Known hypersensitivity to SRL or its derivatives, macrolide antibiotics, corticosteroids, TAC or MMF.
* Multiple organ transplants (i.e., prior or concurrent transplantation of any organs other than renal transplant).

Other exclusions apply.
Med-South Lifestyle Study: Phase 1

The purpose of this study is to determine the processes by which a previously proven lifestyle intervention (the Med-South Lifestyle Program) can most effectively and efficiently be translated into public health and clinical practice to positively impact chronic disease risk reduction among mostly minority, rural, and medically underserved populations.

Purpose: Although lifestyle behavior change interventions are widely recommended to improve health, they are not being implemented sufficiently or equitably on a national scale, particularly in rural communities. The research team has developed and tested multiple lifestyle interventions, which have culminated in the Med-South Lifestyle Program (MSLP), an evidence-based behavior change intervention that translates the PREDIMED (Mediterranean) dietary pattern for a Southeastern US population and includes support for increased physical activity. In this research the investigators propose to identify the most effective and efficient way to scale-up the MSLP for use in public health and clinical practices settings so that it reaches minority, rural, and medically underserved populations.

In Phase 1, the investigators will develop, pilot test, and refine implementation strategies that will be used to take the MSLP to scale.

Participants: Phase I participants include up to 80 participants who will receive the MSLP and for whom the study team will collect baseline and follow-up data.

Procedures (methods): An evidence-based framework for scaling-up health interventions will be used to guide Phase I activities. The initial phase involves refining the "scalable unit" which includes the lifestyle program (MSLP), implementation strategies for the sites that will give the program, and strategies UNC will use to train sites on implementing the program. To refine the scalable unit the investigators will apply a descriptive, qualitative design to assess the feasibility and acceptability of the MSLP's intervention and implementation strategies (i.e., what the investigators will scale-up in Phases 2 and 3). In Phase 1, the study team will recruit 2 local health departments and 2 federally qualified health centers as participating sites. Each site will form an implementation team of 2-4 individuals who will go through training on intervention delivery and implementation. Sites will be randomized to receive training either through a distance (webinar) or in-person/collaborative format. Each site will recruit up to 20 participants (for a total of 80 across all sites) to receive the intervention.

Eligibility Criteria:
Inclusion Criteria:

* Male or female
* English speaking
* Ages 18-80

Exclusion Criteria:

* Malignancy
* Advanced kidney disease (estimated creatinine clearance \< 30 mL/min)
Clinical Study to Evaluate Treatment With ORACEA® for Geographic Atrophy (TOGA)

This is a prospective, randomized study to evaluate the efficacy and safety of ORACEA® in the treatment of geographic atrophy due to dry age-related macular degeneration (AMD).

Eligible participants will complete a 6-month Observation Phase, followed by a 24-month Treatment Phase, followed by an End of Study Visit. Eligible participants will be randomized at Month 6 in a 1:1 ratio to either ORACEA (40 mg doxycycline) or placebo capsule to be taken once-daily for 24 months. Over the course of the 31-month study, a total of 9 clinic visits and 3 telephone calls are required.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, age \>/=55 years
* Best corrected visual acuity of 20/20 - 20/400 in the study eye
* Best corrected visual acuity of hand motion or better in the non-study eye
* Clinical diagnosis of geographic atrophy secondary to non-exudative age-related macular degeneration in at least one eye (study eye)
* Geographic atrophy lesions of ≥ 0.5 and ≤ 7.0 MPS disc areas

Exclusion Criteria:

* History of or active presence of choroidal neovascularization secondary to exudative age-related macular degeneration in the study eye
* History of or active presence of choroidal neovascularization secondary to exudative age-related macular degeneration in the non-study eye requiring any treatment within 12 months prior to Day 0 or expected to require treatment for the duration of the study
* Prior treatment for non-exudative age-related macular degeneration
* Current or previous history of treatment of the study eye with any tetracycline derivative for any ocular condition.
* History of vitreoretinal surgery, corneal transplant, or laser photocoagulation in the study eye
* Any intraocular or periocular surgery within 90 days prior to Day 0 in the study eye.
* History of any hypersensitivity to tetracycline components
* Use of a tetracycline derivative therapy for a concurrent systemic or ocular disorder within 90 days of Day 0
* History of sensitivity to the sun
Cohort IMEA 070 -Lenacapavir Compassional

Immunovirological follow-up and safety of HIV-infected patients receiving lenacapavir under compassionate access in France between 01/01/2021 and 12/31/2023

Retrospective descriptive cohort of patients who received Lenacapavir under compassionate access in France with 50 patients in 25 sites in France

Eligibility Criteria:
Inclusion Criteria:

* Patients who received compassionate access to LEN between 01/01/2021 and 20/12/202

Exclusion Criteria:

* Absence of visits with virological assessment subsequent to inclusion visit
* Participant opposition to use of follow-up data
Muscle Training With and Without Vascular Occlusion of Women With Patellofemoral Pain Syndrome: A Random Clinical Trial

Introduction: The treatment of Patellofemoral Pain Syndrome (PFPS) uses the strengthening of the knee and hip muscles. Studies propose the use of partial vascular occlusion (OVP) of the quadriceps muscle to increase muscle strength and endurance, without joint overload or discomfort to the patient. However, there is no consensus on the use in individuals with PFPS. Objective: To establish the effect of quadriceps muscle strengthening with OVP and low resistance to exercise on pain, functionality, postural control and muscle recruitment in women with patellofemoral dysfunction. Methods: Women with PFPS (n = 20) will respond to pain and functionality scales. The postural control and muscle recruitment of the quadriceps will also be evaluated in dynamic activities of single-legged squat and up / down stairs using a force platform and surface electromyography. After the initial assessment, the participants will be randomized into two groups: conventional quadriceps strengthening with greater resistance loads to exercise and quadriceps strengthening with OVP and low loads. And they will perform a six-week treatment protocol with exercises to strengthen the quadriceps. At the end of the intervention protocols, all of them will be reassessed immediately, after four and eight weeks. Expected Results: It is expected that the group submitted to exercises with OVP and lower load will present the same results of postural control and muscle recruitment compared to the conventional strengthening group. These results will indicate the possibility of using exercises and loads with less joint impairment.


Eligibility Criteria:
Inclusion Criteria:

Insidious onset of symptoms unrelated to trauma, pain for at least three months; pain greater than three (3/10) in at least three of the functional activities (squatting for a long time, going up or down stairs, kneeling, running, remaining in a sitting position for a long time), maximum 86 points on the Anterior Knee Pain Scale (AKPS).

Exclusion Criteria:

Signs and symptoms of other coexisting knee pathologies (arthrosis, prostheses, meniscal and ligament injuries), pain in other joints of the lower limb; lumbar spine pain, neurological, rheumatological, vascular and metabolic diseases; pregnancy; history of lower limb surgery; corticosteroid injection in the knee applied in the last three months, physiotherapy for knee rehabilitation in the last six months.
Dexmedetomidine in Post Spinal Anesthesia Shivering

This study evaluated the effect of dexmedetomidine iv in three different doses in the treatment of shivering in patients undergoing minor elective abdominal surgery under spinal anesthesia, in comparison with intravenous pethidine.

Among the pharmacological agents used in treatment of shivering, pethidine (meperidine) has been shown to be one of the most effective treatments.The α-2 receptor agonists are another important class of anti-shivering drugs that, unlike meperidine, produce little respiratory depression.

Dexmedetomidine is a highly selective α-2 adrenoceptor agonist with potent effects on the central nervous system . Intravenous dexmedetomidine reduces both the vasoconstriction and shivering thresholds . Clinical studies had demonstrated the efficacy of dexmedetomidine in prevention of shivering . Few clinical trials investigated its efficacy in treatment of established shivering. The optimum dose for shivering control with the least hemodynamic derangements is still under research.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologist class I or II scheduled for elective minor lower abdominal operations under spinal anesthesia for an anticipated duration of \>60 and \<180 min. (e.g. inguinal herniorRaphy, umbilical hernia repair) who developed shivering during the intra or postoperative period

Exclusion Criteria:

* Patients with BMI\>30 kg /m2
* Initial body temperature \>38 C or \<36 C and those with a history of convulsions
* Multiple allergies
* Thyroid disease
* Parkinson's disease
* Dysautonomia
* Raynaud's syndrome
* Hypertension
* Coronary artery disease or other cardio-respiratory or neuromuscular pathology
* Middle ear pathology
* A known history of alcohol use
* Treatment with sedative hypnotic agents or vasodilators
* Having contraindications to spinal anesthesia
Evaluation of the Pharmacokinetics and the Pharmacodynamics of Different Dry Powder Inhalation Formulations of AZD3199 in Patients With Asthma

The purpose of this study is to evaluate the pharmacokinetics and pharmacodynamics of single doses of three different dry powder inhalation formulations of AZD3199 administered via Single Inhalation Device (SID) compared to AZD3199 administered via Turbuhaler™ Inhaler and compared to placebo in patients with persistent asthma.


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated written informed consent prior to any study specific procedures
* Men or women, age ≥ 18 years. Women must be of non-childbearing potential or stable on a highly effective contraceptive method for at least 3 months prior to Visit 1 and be willing to continue on the chosen contraceptive method throughout the study.
* Be a non-smoker or ex-smoker who has stopped smoking for \>6 months prior to study start
* A history of asthma for at least 6 months.
* Body Mass Index (BMI) 19-30 kg/m2

Exclusion Criteria:

* Significant disease or disorder which, in the opinion of the Investigator, may either put the patient at risk because of participation in the study, or influence the result of the study, or the patient's ability to participate in the study
* History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator or history of hypersensitivity to β2-agonists in general or to AZD3199 and/or excipients
* Prolonged QTcF \> 450 msec or shortened QTcF \<340 msec
* History of alcohol/drug abuse or excessive intake of alcohol as judged by the Investigator
* Pregnancy or lactation
Contrast Enhanced Transrectal Ultrasonography (TRUS) to Assess Prostatic Vascularity After Radiotherapy (XRT)

Solid tumors, including prostate cancer, commonly exhibit tumor-associated neovascularity (growth of new blood vessels to feed the tumor) with increased microvessel density. Systemic, hormonal, and radiotherapy treatments typically decrease or suppress tumor - associated vascularity through several mechanisms, including apoptosis (process of cell death) and anti-angiogenic pathways (ways to destroy new blood vessel growth). Previously at the investigators' center, they have demonstrated that increased prostatic vascularity (blood vessels defined to prostate) detected ultrasonographically correlated with disease free survival after radical prostatectomy (surgical removal of entire prostate), and may be indicative of higher grade, higher stage disease. The significance of prostate neovascularity in response to treatment with external beam radiotherapy (EBRT) (standard of care) has not been well studied. The investigators hypothesize that prostate cancer that recurs after radiotherapy may exhibit measurable patterns of tumor-associated vascularity, which may represent a minimally invasive marker of cancer stage, grade and response to treatment. The investigators propose a pilot study to assess the feasibility of serial enhanced transrectal ultrasonography (TRUS) examinations during and after radiotherapy for prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

* Men aged 40 - 80 years old
* Biopsy proven intermediate/high risk clinically localized prostate cancer, as determined by a Gleason score of 7 or higher, clinical stage T2b or higher, or PSA \> 10. Pathology will be confirmed by at least two reviews
* Patients opting for EBRT (external beam radiation therapy, standard of care) without hormonal ablation
* Ability to undergo serial TRUS procedures
* Ability to give informed consent

Exclusion Criteria:

* Subject has known hypersensitivity to octafluoropropane.
* Evidence of distant metastatic disease on staging evaluation
* Previous treatment for prostate cancer, including any form of androgen ablation
* Previous procedures involving the anus or rectum, making serial TRUS difficult or dangerous
* Expected life expectancy less than 10 years
* Baseline testosterone \< 200 ng/dL
* Subject with cardiac shunts and elevated pulmonary hypertension
* Subject has worsening or clinically unstable congestive heart failure.
* Subject has acute myocardial infarction or acute coronary syndrome.
* Subject has ventricular arrhythmias or is high risk for arrhythmias.
* Subject has respiratory failure, severe emphysema or pulmonary emboli.
* Subject has a history of cardiac shunt or pulmonary hypertension.
Modified Interactive Screening Program Plus MINDBODYSTRONG: a Mental Health Resiliency Intervention for Nurses

The overall purpose of this study is to evaluate the efficacy of an intervention designed to prevent nurse suicide. This randomized controlled trial will test the modified Interactive Screening Program (mISP) alone and the mISP combined with a program called MINDBODYSTRONG.

The mISP is a method of screening to detect clinicians at moderate to high risk for suicide and referring them for treatment through an encrypted anonymous on-line platform. MINDBODYSTRONG© is an adaptation of a well-tested cognitive-behavioral skills building intervention (also known as COPE in the literature) that provides a cognitive-behavior theory-based approach to decrease depression, anxiety and suicidal ideation and improve healthy lifestyle beliefs and behaviors in at-risk populations. MINDBODYSTRONG© will involve eight self-paced computerized sessions designed specifically for nurses and clinicians. Nurses will be recruited nationally through the professional nursing organizations and health systems.

The study will be the first to test the combination of the mISP with a new on-line digitalized version of the previously tested manualized version of the CBSB program (i.e., MINDBODYSTRONG©) for nurses. If found to be effective, the combined program will be able to be easily scaled to prevent suicide in nurses and potentially other high-risk populations of clinicians. Although CBT is gold standard evidence-based treatment for depression, only a small percentage of affected individuals receive it due to a shortage of mental health providers, which contributes to high depression relapse rates of 50 to 70%. A scalable digitalized intervention could be one key solution to bringing CBT skills to nurses at risk for suicide who could so benefit from them. This randomized controlled trial (RCT) will determine the effects of the mISP, this adaptation of the American Foundation for Suicide Prevention's (AFSP) Interactive Screening program (ISP), combined with the on-line version of the MINDBODYSTRONG© program versus the HEAR program alone on depression, suicidal ideation, burnout, anxiety, post-traumatic stress, healthy lifestyle beliefs, healthy lifestyle behaviors, and job satisfaction in U.S. nurses.

Eligibility Criteria:
Inclusion Criteria:

* self-identify as a registered nurse
* identified as moderate to high risk of suicide by the mISP-specific interactive screening program assignment

Exclusion Criteria:

* low risk of suicide by the mISP-specific interactive screening program assignment
* under the age of 18 years
* prior participation in MINDBODYSTRONG
* prior participation in this study
Early Exclusive Enteral Nutrition in Early Preterm Infants

Enteral nutrition in preterm infants is usually started and advanced slowly until reaching full enteral feeds. Most preterm infants born before 34 weeks gestation require parenteral fluids to maintain normal blood sugar level and prevent excessive weight loss and dehydration. Availability of donor human milk (DHM) along with low incidence of necrotizing enterocolitis (NEC) in preterm infants born at 30-33 weeks have encouraged neonatologists to start feeding early and advance it faster in order to shorten time on parenteral nutrition (PN) and minimize the need for intravenous access. The objectives of this trial is to study whether exclusive enteral nutrition from day of birth (i.e. no PN) results in shorter time to achieve full enteral feed when compared with traditional feeding regimen that involves a combination of PN and progressive enteral feeding.

Early nutritional support of preterm infants born at 30-33 weeks gestation is usually achieved via a combination of parenteral nutrition (PN) and enteral feeding that is advanced over few days to reach full enteral feed. Recent studies suggest that rapid increase of enteral feed volumes results in shorter duration on PN and earlier achievement of full enteral feed without increasing the risk of necrotizing enterocolitis (NEC) or death. Although PN has an important role in nutrition of preterm infants, it is associated with increased risk of metabolic and infectious complications even when it is used for a short period of time. Furthermore, PN mandates the need for peripheral or central intravenous access. Provision of full enteral feed volume that meets reference daily fluid intake from day of birth is used frequently and successfully in stable preterm infants born after 33 weeks. Expanding the use of this regimen to stable preterm infants born at 30-33 weeks gestation may help avoid unnecessary start of intravenous access, prevent complications related to PN, and encourage mother-infant bonding experience.

Eligibility Criteria:
Inclusion Criteria:

1. Preterm infants born at 30 0/7 - 33 6/7 weeks gestation
2. Birth weight greater than 1000 g
3. Consent to use donor human milk
4. Postnatal age is less than 48 hours from birth
5. Infant is ready to start on feeding (as per clinical team) or feeding volume, when already started, is ≤12 ml/kg per day (total) and/or the infant received ≤2 feeds based on current feeding policy or physician descrition (total volume of the received feeds is ≤20 ml/kg per day).

Exclusion Criteria:

1. Cord PH \< 7.00 or Cord base access (BE) \< -16
2. Apgar score \< 7 at 5 minute
3. Lactate level ≥3 (if done for clinical indication)
4. Need for positive pressure ventilation (PPV) for \>1 minute.
5. Hemodynamic instability (hypotension or poor perfusion at any time in this 48 hours)
6. Small for gestational age \<3 percentile on Fenton chart and/or fetal absent or reversed umbilical arterial end-diastolic blood flow.
7. Major congenital malformation
8. Symptomatic or severe hypoglycemia (blood glucose \<1.8 mmol/L)
9. Infants with moderate to severe respiratory distress.
Lower Body Positive Pressure Treadmill Training in Post-Stroke Gait Impairment

Lower body positive pressure (LBPP) decreases weight bearing and ground reaction forces, with potentially positive effects on qualitative gait indices. However, which gait features are shaped by LBPP gait training in post-stroke patients is still poorly predictable. A pilot study on the effects of LBPP gait training on qualitative and quantitative gait indices in patients with hemiparesis due to stroke in the chronic phase was carried out. Twenty-five patients who suffered from a first, single, ischemic, supra-tentorial stroke occurred at least 6 months before study inclusion were provided with 24 daily sessions of LBPP treadmill gait training using AlterG device. These patients were compared with 25 age-matched healthy controls (HC), who were formerly provided with the same amount of AlterG training, and 25 patients with the same clinical-demographic characteristics of the first group of patients, who previously underwent conventional treadmill gait training (TGT). Qualitative and quantitative gait features, including Functional Ambulation Categories, gait cycle features, and muscle activation patterns were analyzed before and after the training (AlterG or TGT).


Eligibility Criteria:
Inclusion Criteria:

* age ≥ 55 years;
* first, single, ischemic supra-tentorial stroke occurred at least 6 months before the study inclusion;
* a Functional Ambulatory Categories (FAC) score of \>2;
* ability to control head and trunk posture;
* no systemic or cardiovascular contraindication to LBPP

Exclusion Criteria:

• Medical and/or psychiatric illness potentially interfering with the treatment.