cyrilzakka/clinical-trials huggingface dataset:
Engaging Medically Complex Veterans in Tele-Rehabilitation Using a Biobehavioral Approach

The aims of this study are to determine the feasibility and acceptability of a multicomponent telerehabilitation program for medically complex older Veterans and to preliminarily assess participant outcomes (physical activity, physical function, quality of life, loneliness) to the program.

The aims of this study are to determine the feasibility and acceptability of the multicomponent telerehabilitation program and to preliminarily assess participant outcomes. The multicomponent program/intervention consists of 3 core components: 1) high-intensity rehabilitation interventions, 2) biobehavioral interventions, and 3) social support. The delivery of the program is supported by various technologies allowing for synchronous and asynchronous care and monitoring. Synchronous telerehabilitation will occur individually and in virtual groups. Feasibility and acceptability will be assessed by Veteran adherence to program components and validated surveys. Preliminary responsiveness will be assessed primarily by change in 7-day average step count and secondarily by other physical function tests and patient reported outcome measures. Study findings will have immediate clinical impact as they will guide implementation of safe and effective telerehabilitation strategies for medically complex older Veterans who lack access to standard in-person rehabilitation services.

Eligibility Criteria:
Inclusion Criteria:

* 60 years of age and older
* Multiple chronic conditions (Charlson Comorbidity Index 3)
* Impaired physical function (\< or = 10 repetitions on 30 second sit to stand test)

Exclusion Criteria:

* Life expectancy \< 12 months
* Acute or progressive neurological disorder (e.g. Amyotrophic Lateral Sclerosis, recent stroke)
* Moderate to severe dementia without caregiver assistance (\< 18 on telephone Montreal Cognitive Assessment (MoCA Blind)
* Unstable medical condition precluding safe participation in progressive rehabilitation (e.g. unstable angina)
Effects of a Home-based Exercise Program on Functional Capacity and Quality of Life in Heart Failure Patients

Heart failure (HF) is a multisystemic disease leading to exercise intolerance and fatigue. Supervised physical training improves functional capacity, quality of life and reduces hospital admissions in HF patients. In this way, home physical training may be a good alternative to patients who, for any reason, cannot perform supervised training. Objective: To asses the effects of a home-based training program on functional capacity, sedentary lifestyle and quality of life of patients with chronic HF compared to supervised training.

After agreement with the written informed consent, subjects with heart failure (left ventricle ejection fraction bellow or equal 40%) will be included in this study. They will be randomized in two groups: Home-based and Supervised exercise groups. The two groups will be submitted to a twelve-week combined exercise program of aerobic and peripheral muscle training. All volunteers will be assessed at baseline and after twelve weeks of intervention. Peripheric and respiratory muscle strength as well the 6MW analyses were assessed also at 4 and 8 weeks after baseline.

Eligibility Criteria:
Inclusion Criteria:

* Chronic heart failure (functional class from NYHA II and III),
* Left ventricle ejection fraction bellow or equal to 40%
* Clinical stability during the last three months
* Medical release for physical training after cardiopulmonary test

Exclusion Criteria:

* Uncontrolled arrhythmia
* Pulmonary artery systolic pressure \> 35 mmHg by the echo doppler cardiogram,
* Peripheral oxygen saturation \< 92% in resting condition
* Respiratory infection in the previous 30 days to the enrollment into the study
* Cognitive, neurological or orthopedic limitations
Exercise Rehabilitation of Younger and Older People With Claudication

The purpose of this study is to examine the effect of age and the effect of exercise intensity of rehabilitation programs on claudication pain symptoms and leg circulation of younger and older patients with intermittent claudication.

Thirty-one patients randomized to low-intensity exercise rehabilitation and 33 patients randomized to high-intensity exercise rehabilitation completed the study. The 6-month exercise rehabilitation programs consisted of intermittent treadmill walking to near maximal claudication pain three days per week at either 40% (low-intensity group) or 80% (high-intensity group) of maximal exercise capacity. Total work performed in the two training regimens was similar by having the patients in the low-intensity group exercise for a longer duration than patients in the high-intensity group. Measurements of physical function, peripheral circulation, and health-related quality of life were obtained on each patient before and after the rehabilitation programs.

Eligibility Criteria:
Inclusion Criteria:

* History of intermittent claudication
* Exercise tolerance limited by intermittent claudication during a screening treadmill test
* Ankle/brachial index (ABI) at rest less than 0.90
* Live independently at home

Exclusion Criteria:

* Absence of PAD (peripheral artery disease)
* Asymptomatic PAD (Fontaine stage I)
* Rest pain PAD (Fontaine stage III)
* Exercise tolerance limited by factors other than claudication (e.g., coronary artery disease, dyspnea, poorly controlled blood pressure)
* Active cancer, renal disease, or liver disease
* Current use of pentoxifylline or cilostazol medications for the treatment of intermittent claudication
Neutrophil Extracellular Trap Formation in Newborn Infants at Risk for Inflammatory Syndromes

The purpose of this study is to characterize the time to maturation of neutrophil extracellular trap(NET) formation capability in polymorphonuclear leukocytes(PMNs) isolated from newborn premature and term infants. Preterm infants who are enrolled into the study who then go on to require surgery \<1 year due to surgical NEC, will have the NET formation reassessed. This study will also determine whether NETs contribute to the pathogenesis of necrotizing enterocolitis (NEC). We hypothesize that NET formation contributes to the pathogenesis of NEC by inappropriately releasing degradative proteins and tissue destructive enzymes into the inflammatory milieu of the premature infant gastrointestinal tract following bacterial translocation. We also hypothesize that the delay in NEC development in premature infants (3rd - 4th week of life) as compared to at-risk term infants (1st week of life) results from a developmental delay in PMN ability to form NETs.

Prematurely born infants are at risk for necrotizing enterocolitis (NEC), the most common gastrointestinal emergency encountered in the newborn intensive care unit. This disease occurs in between 5 - 10% of infants born at less than 30 weeks gestation or less than 1500 grams birth weight. In these patients, NEC routinely develops during the 3rd or 4th week of life. NEC rarely occurs in infants born closer to term; for these patients NEC usually develops during the 1st week of life. So far, no one has explained the inverse relationship between gestational age at birth and the delay in NEC development.

Recently, our laboratory described for the first time an inherent deficiency of innate immunity in newborn infants - failure of neutrophil extracellular trap formation. Neutrophil extracellular traps or NETs are complex lattices of extracellular chromatin and DNA decorated with anti-microbial proteins and degradative enzymes which trap and kill microbes. When the neutrophils of newborn infants develop the ability to form NETs and whether the maturation of NET formation correlates with development of NEC in at risk infants remains unknown.

We have therefore undertaken the following study best described as a prospective, in vitro longitudinal cellular biology study of LPS/PAF-stimulated PMNs isolated from the cord and peripheral blood of premature infants at risk for NEC and from term infants not considered at risk for NEC. We will also assay for NET formation in gastrointestinal tissue samples obtained at the time of surgery for severe NEC in enrolled prematurely born infants. These studies are the first of their kind and aim to answer these important questions.

Eligibility Criteria:
Inclusion Criteria:

1. Preterm infant patients delivered at UUMC and hospitalized in the NICU who are ≤ 1500 grams or \<30 weeks gestational age at birth
2. Term infants delivered at UUMC without complication, either via cesarean section or vaginal delivery

Exclusion Criteria:

* No other exclusion criteria
Oxytocin i.m./i.v. Versus Carbetocin i.v. in Elective Cesarean Sections

Objective is to proof non-inferiority of intramyometrial and intravenous oxytocin application compared to intravenous carbetocin for prevention of postpartum hemorrhage in planned, uncomplicated cesarean deliveries.


Eligibility Criteria:
Inclusion Criteria:

* elective cesarean section
* present informed consent
* completed 36 weeks of gestation

Exclusion Criteria:

* need for intubation (carbetocin is only licensed for epidural or spinal anesthesia)
* multiple fetus pregnancy
* known coagulopathy
* Placenta praevia
* morbidly adherent placenta
* placental abruption
* thrombocyte dysfunction
* HELLP-syndrome
* preeclampsia
* history of uterine atony
A Study of XL844 Administered as a Single Agent and in Combination With Gemcitabine in Adults With Advanced Malignancies

The purpose of this study is to determine a safe dose of XL844 in combination with gemcitabine, how often it should be taken, and how well people with cancer tolerate the combination of gemcitabine and XL844.


Eligibility Criteria:
Inclusion Criteria:

1. The subject has a histologically confirmed advanced malignancy (solid tumor or lymphoma) that is metastatic or unresectable, and for which standard curative or palliative measures do not exist or are no longer effective, and there are no therapies known to prolong survival.
2. The subject has disease that is assessable by tumor marker, physical, or radiologic means.
3. The subject is ≥18 years old.
4. The subject has an ECOG (Eastern Cooperative Oncology Group) performance status of ≤2.
5. The subject has adequate organ and marrow function.
6. The subject has the capability of understanding the informed consent document and has signed the informed consent document.
7. Sexually active subjects (male and female) must use medically acceptable methods of contraception during the course of the study.
8. Female subjects of childbearing potential must have a negative pregnancy test at screening.
9. If a subject has received more than three prior regimens of cytotoxic chemotherapy, more than two biologic regimens, or more than 3000 cGy to \>25% of his or her bone marrow, the investigator must discuss with the sponsor regarding subject suitability before enrollment.
10. The subject has had no other diagnosis of malignancy (unless non-melanoma skin cancer, in situ carcinoma of the cervix, or a malignancy diagnosed ≥5 years ago, and has had no evidence of disease for 5 years prior to screening for this study).

Exclusion Criteria:

1. The subject has received anticancer treatment (eg, chemotherapy, radiotherapy, immunotherapy, biologic therapy, investigational agent, or hormones) within 14 days prior to the first dose of study drug.
2. The subject has not recovered to Grade ≤1 from adverse events (AEs) due to investigational agents or other medications administered more than 30 days prior to the first dose of study drug.
3. The subject has received radiation to \>25% of his or her bone marrow within 30 days of XL844 treatment.
4. The subject has a primary brain tumor or known brain metastases.
5. The subject has uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, hypertension, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
6. The subject is pregnant or breastfeeding.
7. The subject is known to be positive for the human immunodeficiency virus (HIV).
8. The subject is unable or unwilling to abide by the study protocol or cooperate fully with the investigator or designee.
9. The subject has a known allergy or hypersensitivity to any of the components of the XL844 formulation or gemcitabine.
A RCT of CenteringPregnancy on Birth Outcomes

The purpose of this study is to evaluate whether CenteringPregnancy group prenatal care can improve preterm birth rate and other birth outcomes, maternal psychosocial and behavioral outcomes, and decrease the racial difference in selected birth outcomes among African American and White women, compared to individual prenatal care.

This is a randomized controlled trial to compare biomedical, behavioral and psychosocial outcomes by race among pregnant women who participate in CenteringPregnancy group prenatal care, to women in the traditional individual prenatal care and to investigate whether improving women's stress, activation and engagement will explain the potential benefits of CenteringPregnancy on outcomes and health disparities. The trial will be conducted in a large prenatal care center in South Carolina. Eligible White and Black women will be recruited before 20 weeks of gestational age with low risk pregnancy.

Eligibility Criteria:
Inclusion Criteria:

1. Pregnant women aged between 14-45 years
2. Entry prenatal care before 20 6/7 weeks gestational age (defined as attendance at the intake screening visit). Patients must be randomized by 23 6/7 weeks gestational age.

Exclusion Criteria:

1. Medical complications of pregnancy that would preclude prenatal care provision by nurse practitioners or participation in group care

   * Pregestational diabetes,
   * Severe chronic hypertension requiring medication,
   * Morbid Obesity with BMI \>49.99
   * Renal disease with baseline proteinuria \>1g/24 hours
   * Any disease requiring chronic immunosuppression (SLE, solid organ transplant)
   * Active pulmonary tuberculosis
   * Sickle cell anemia
   * Human Immunodeficiency Virus Infection
   * Other medical conditions that would exclude women from group care at the discretion of the PI
2. Pregnancy complications that would preclude prenatal care provision by nurse practitioners or participation in group care

   * Multiple gestation
   * Lethal fetal anomalies
   * Other pregnancy complications that would exclude women from group care at the discretion of the PI
3. Social and behavioral complications of pregnancy which would preclude prenatal care provision by nurse practitioners or participation in group care

   * Current incarceration
   * Severe psychiatric illness
EuroPainClinicsStudy X

Non-interventional, retrospective-prospective cohort study based on the collection of data and their evaluation after medical procedures: micro-discectomy, endoscopic discectomy, and hemilaminectomy.

The aim of this clinical study is to compare the benefits and complications after minimally invasive spinal procedures in patients with acute lumbosacral radicular syndrome caused by a herniated disc compressing the spinal neural structures.

The study only works with patient data provided by the outpatient clinic for research analysis in the EPCS IV clinical study. All patient data are encrypted during collection and evaluation during the study, and stored in an encrypted database. The data will be evaluated by an independent institution - The Institute of Measurement of the Slovak Academy of Sciences.

Eligibility Criteria:
Inclusion Criteria:

* patient age 18-60 years
* first spinal surgery in the areas L1-S1
* signed informed consent for the participation in the study

Exclusion Criteria:

* patients with a history of other back problems (compression fracture, spondylitis, tumour)
* patients after repeated spinal surgeries
* patients with a systemic disease affecting the muscles elite athletes
* patients who disagree to participate in the study
* women with a positive pregnancy test or women planning on becoming pregnant
Dengue Serostatus Study in the Philippines

This is an observational study for 5 years, and aims to determine the risk of developing dengue among Philippine children who are eligible to receive the dengue vaccine during the DOH mass dengue vaccination, by dengue serostatus at baseline.

This is a cohort study that aims to determine the relative risk of developing virologically-confirmed dengue among Philippine children who are eligible to receive dengue vaccine during the DOH Mass Dengue Vaccination. Additionally, it also aims to determine the relative risk of developing severe and/or hospitalized virologically-confirmed dengue among Philippine children who received the Dengue vaccine, describe the epidemiologic trends and characteristics of virologically-confirmed dengue among these children, and assess the performance of simpler tests such as dried blood spots and serum IgG for the assessment of dengue seroprevalence at the population level. We will enroll children who are residents of selected areas in Region 7, Philippines. Children should be eligible to participate in the Department of Health mass dengue vaccination. They will be prospectively venipunctured for baseline dengue serologic status. The blood samples will be stored for serologic testing using neutralization tests and commercial IgG tests. Children in the cohort will be followed up, and those who present with \<5 days of fever will be identified and blood drawn for dengue LAMP and RT-PCR.

Eligibility Criteria:
Inclusion criteria:

* Provide signed informed consent and assent (as applicable)
* Be a child belonging to the specified age group and resident of the targeted communities of the DOH dengue mass immunization
* Be eligible to receive dengue vaccine during the DOH dengue mass immunization in 2017

Exclusion criteria:

* Any subject whose parent/guardian refuse to provide informed consent and/or assent
* Children who do not belong to the specified age groups and not residents of the targeted communities
* Children \<9 years old
* Children with history of bleeding disorder
* Any subject previously enrolled in a dengue vaccine clinical trial
Observational Study on Efficacy of Alvesco(Ciclesonide) in Asthma Children and Adolescent in Real Practice

This is a prospective, non-comparative, open, observational study.


Eligibility Criteria:
Inclusion Criteria:

* Children who is prescribed with ciclesonide for asthma

Exclusion Criteria:

* Subjects with contraindications to ciclesonide use
* Subjects with clinically relevant concomitant disease that could compromise the patient's safety should not be included in this study.
Clinical Evaluation of the SNaP Wound Care System

The purpose of this study is to assess the efficacy of design improvements of the Spiracur SNaP Wound Care System. This study prospectively evaluates the safety and efficacy of current and new design iterations of components of the FDA-cleared Spiracur SNaP Wound Care System in order to optimize safety, efficacy, and system performance.


Eligibility Criteria:
Inclusion Criteria:

* Wound \< 10 cm in greatest diameter
* Patient \>18 years of age
* Willing and able to sign informed consent

Exclusion Criteria:

* Patients with wound-related cellulitis
* Patients with thick eschar at wound base post debridement
* Patients with wounds located in an area not amenable to forming an air- tight seal
* Ulcers due to inflammatory conditions such as pyodermagangrenosum, rheumatoid arthritis, vasculitis, cryoglobulinemia, necrobiosislipoidicadiabeticorum, lupus or pancreatic panniculitis, cryofibrinogenemia, calcinosis cutis, scleroderma, Raynaud's syndrome
* Patient has untreated osteomyelitis
* Patient is allergic to wound care products
* Patient wounds with exposed blood vessels not suitable for negative pressure therapy
* Pregnant or pregnancy-suspected patients
* Subject actively participating in other clinical trials that conflict with the current study
A Sudy to Evaluate the Efficacy and Safety of TNM001 in High-risk Infants

This study is a Phase 3 randomized, double-blind, placebo-controlled study to evaluate the safety, efficacy, and immunogenicity of TNM001 in high-risk infants when entering their RSV season. Approximately 201 infants will be randomized in a ratio of 2:1 to receive TNM001 or placebo. All subjects will be followed for 270 days after dosing. This study will be conducted at approximately 20 sites in China.


Eligibility Criteria:
Inclusion Criteria:

* 1.High risk infants under 1 year of age who are entering their first RSV season at the time of screening.
* 2.Subject's legal representative(s) is(are) able to understand and comply with the requirements and procedures of the protocol,including scheduled visits and sample collection.
* 3.Subject is available to complete the follow-up period.

Exclusion Criteria:

* 1. Any fever (\> 38.0°C) or acute illness within 7 days prior to randomization
* 2. History of RSV infection
* 3. Being hospitalized at the time of randomization
* 4. Currently receiving or expected to receive immunosuppressive therapy during the study period.
* 5. Renal impairment or hepatic dysfunction
* 6. Nervous system disease or neuromuscular disease
* 7. Known immunodeficiency including HIV, mother with HIV infection unless the child's infection has been excluded.
* 8. Known allergy history of immunoglobulin products, receipt or expected to receive immunoglobulins or blood products during the study period.
* 9.Receipt of RSV vaccine or mAb
* 10.Receiving blood products before randomization