cyrilzakka/clinical-trials huggingface dataset:
Family-centered HIV Care, Viral Suppression and Retention in HIV-positive Children, Swaziland

The study will evaluate the effect of implementing a family-centered care (FAM-CARE) program (where all HIV-positive family members are seen together as a unit and receive care together) on viral suppression and retention in HIV-positive children \<15 years through enrollment of a prospective cohort of 660 HIV-positive children and their caregivers at sites that were randomized to either implement the family-care program (intervention sites) or continue the current standard of care (control sites).

The proposed study will evaluate the effect of implementing a FAM-CARE program on viral suppression and retention in children through enrollment of a prospective cohort of HIV-positive children and their caregivers at sites implementing the FAM-CARE program and control sites continuing the current standard of care. The study will be conducted in four "clusters" of facilities (2 hospitals and 2 health centers and their filter clinics) in the Hhohho region of Swaziland. Two facility "clusters" (one hospital and one health center, with their filter clinics) will be randomized to initiate the FAM-CARE program with viral load monitoring and two "clusters" (one hospital and one health center, with their filter clinics) will be control standard-of care sites. A prospective cohort of HIV-positive children and their caregivers will be followed in the FAM-CARE program sites and control sites. Each child will be followed for 18 months following enrollment. The primary objective is to evaluate the effect of the FAM-CARE program on the rates of viral suppression and retention in care, comparing rates of viral suppression and retention in children enrolled in FAM-CARE versus control sites. The study will also evaluate factors associated with viral suppression and retention (including family demographic characteristics), and conduct qualitative interviews to assess the acceptability of the FAM-CARE program by caregivers and health care providers in the intervention sites.

Eligibility Criteria:
Inclusion Criteria:

* HIV-positive child aged \<15 years receiving HIV care at the study facility.

Exclusion Criteria:

* At least one family member residing in the household is also HIV-positive and is receiving services at the study facility
ImPRoving Adherence to Immunosuppressive Therapy by Mobile Internet Application in Solid Organ Transplant Patients

Nonadherence to immunosuppression is a leading cause of late graft rejection, chronic rejection and graft failure and it is regarded as a preventable cause of graft loss after solid organ transplantation. The purpose of this study is to evaluate whether mobile application for drug medication can enhance the drug adherence rate.


Eligibility Criteria:
Inclusion Criteria:

* 1 year after kidney transplantation
* out-patient follow up in Seoul National University Hospital
* using android smartphone
* taking Prograf as a main immunosuppressant
* 15-70 years

Exclusion Criteria:

* patients who cannot use medication event monitoring system
* multiorgan transplant
* immunosuppression medication change within 4 weeks of randomization
* caregiver management of the medication regimen
* pregnancy
* patients who can not use mobile application
Study of ARO-RAGE in Healthy Subjects and Patients With Inflammatory Lung Disease

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics of ARO-RAGE in normal healthy volunteers (NHVs) and in participants with inflammatory lung disease (asthma). In Part 1 of the study, NHVs will receive a single dose of ARO-RAGE or placebo. In Part 2 of the study, adult participants with asthma will receive 2 doses of ARO-RAGE or placebo. Additional NHVs may be randomized to receive 1 or 2 doses of ARO-RAGE or placebo at Sponsor discretion. Dose levels in Part 2 will be determined based on cumulative safety and pharmacodynamic data from Part 1.


Eligibility Criteria:
Inclusion Criteria:

* Normal pulmonary function tests at Screening (NHVs only)
* Confirmed diagnosis of asthma based on source verifiable medical record (asthma patients only)
* No abnormal finding of clinical relevance at Screening (other than asthma for asthma patients)
* Stable dose of asthma controller medications prior to Screening (asthma patients only)
* If on allergen-specific immunotherapy, participants must be on a stable maintenance dose
* Non-smoking
* Women of childbearing potential must have a negative pregnancy test, cannot be breastfeeding, and must be willing to use contraception. Males must not donate sperm during the study and for at least 12 weeks following the last dose of study drug
* Willing to provide written informed consent and to comply with study requirements

Exclusion Criteria:

* Acute lower respiratory infection or asthma exacerbation within 30 days prior to first dose
* Positive COVID-19 test during Screening window
* Use of immunosuppressive medication within 90 days prior to first dose
* Receipt of any intranasal vaccine within 30 days prior to first dose
* Use of systemic corticosteroid therapy within 90 days prior to first dose
* Clinically significant health concerns (other than asthma in asthma patients)
* Human Immunodeficiency virus (HIV) infection, seropositive for Hepatitis B Virus (HBV), seropositive for Hepatitis C Virus (HCV)
* Uncontrolled hypertension
* Unwilling to limit alcohol consumption to within moderate limits for the duration of the study
* Use of illicit drugs
* Use of an investigational agent or device within 30 days prior to first dose

Note: additional inclusion/exclusion criteria may apply per protocol
L-carnitine for Fatigue in COPD

supplementation with L-carnitine that is available both as an FDA-approved therapy for primary carnitine deficiency, as well as widely available as an over-the-counter ergogenic aid will improve wellbeing and function measured by questionnaires in patient with chronic obstructive pulmonary disease (COPD).

based on our review of literature that addition of health coaching (HC) to L-carnitine will yield greater gains.


Eligibility Criteria:
Inclusion criteria:

- COPD patients with a positive screen for fatigue

Exclusion criteria:

* Vulnerable population - pregnant women, prisoners, unable to provide consent
* Pre-menopausal/breastfeeding women (pregnancy category B)
* Thyroid disease
* Anticoagulation therapy
* Decompensated cardiac disease
* Chronic Kidney Disease (CKD4 or above)
* Known seizure disorder
* Active malignancy
* Exacerbation of underlying pulmonary disease or acute illness in the 6 weeks before screening
* Enrollment in the past 6 weeks or currently in a cardiac or pulmonary rehab program or other physical fitness class(es).
* Difficulty with swallowing pills
The Efficacy of Cobitolimod in Patients With Moderate to Severe Active Ulcerative Colitis

The purpose of this study was to evaluate efficacy of cobitolimod treatment at different dose levels and frequencies compared to placebo in patients with moderate to severe left-sided ulcerative colitis.

This was a Phase IIb study in patients with moderate to severe left-sided ulcerative colitis. Patients either received cobitolimod 31 mg, 125 mg or 250 mg at two occasions or 125 mg or placebo at four occasions during a 3-weeks period. To ensure blindness, patients received active treatment at two occasions and placebo at the other two occasions. Blood, stool, and tissue samples was collected at various time points throughout the study to evaluate safety and efficacy. Primary endpoint was evaluated at week 6.

Duration of participation for patients was approximately 12 weeks (from screening to final follow-up visit).

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old
* Established diagnosis of Ulcerative Colitis (UC)
* Moderately to severely active left sided UC assessed by central reading
* Current oral 5-Aminosalicylic Acid (5-ASA)/ Sulphasalazine (SP) use or a history of oral 5-ASA/SP use
* Current Glucocorticosteroids (GCS) use or history of GCS dependency, refractory, or intolerance
* Demonstrated an inadequate response, loss of response, or intolerance to at least one of the following agents:

  * Immunomodulators
  * Tumor Necrosis Factor alpha (TNF-α) inhibitors and/or anti-integrins

Exclusion Criteria:

* Suspicion of differential diagnosis
* Acute fulminant UC and/or signs of systemic toxicity
* UC limited to the rectum (disease which extend \<15 cm above the anal verge)
* History of malignancy
* History or presence of any clinically significant disorder
* Concomitant treatment with cyclosporine, methotrexate, tacrolimus, TNF-α inhibitors, anti-integrins or similar immunosuppressants and immunomodulators
* Treatment with rectal GCS, 5-ASA/SP or tacrolimus
* Long term treatment with antibiotics or non-steroidal anti-inflammatory drugs (NSAIDs)
* Serious active infection
* Gastrointestinal infections
* Currently receiving parenteral nutrition or blood transfusions
* Females who are lactating or have a positive serum pregnancy test
* Women of childbearing potential not using reliable contraceptive methods
* Concurrent participation in another clinical study
* Previous exposure to cobitolimod
Study to Assess BMD and Bone Turnover Response to 5 mg Daily Risedronate Treatment in Women With PMO

A 2-year, Multicenter, Open-label, Phase IIIb Extension Study to Assess Bone Mineral Density and Bone Turnover Response to 5 mg Daily Risedronate Treatment in Women with Postmenopausal Osteoporosis Who Sequentially Completed Clinical Studies RVE009093, RVE1996077, RVE1998080, and RVE2001079 (NCT01249261)

A 2-year, Multicenter, Open-label, Phase IIIb Extension Study to Assess Bone Mineral Density and Bone Turnover Response to 5 mg Daily Risedronate Treatment in Women with Postmenopausal Osteoporosis Who Sequentially Completed Clinical Studies RVE009093, RVE1996077, RVE1998080, and RVE2001079 (NCT01249261)

Eligibility Criteria:
Inclusion Criteria:

* have satisfactorily completed Clinical Study RVE2001079 (Year 8 extension study)

Exclusion Criteria:

* Can not use any bone modifying substances except risedronate
A Safety and Efficacy Study of Golimumab (CNTO 148) in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy

The purpose of this study is to evaluate the safety and effectiveness of golimumab in patients with active rheumatoid arthritis despite Methotrexate therapy. Another objective is to evaluate the pharmacokinetics of golimumab.

This clinical study is scheduled to be performed for the purpose of evaluating the safety and effectiveness of golimumab (CNTO148) administered in combination with stable dose (6-8mg/week) of methotrexate (MTX) to patients with rheumatoid arthritis (RA). CNTO148 50 mg group: CNTO148 50 mg SC injections every 4 weeks from the first administration until week 152. If early escape, 100 mg SC injections every 4 weeks from week 16 until week 152. CNTO148 100 mg group: CNTO148 100 mg SC injections every 4 weeks from the first administration until week 152 whether early escape or not Placebo group: Placebo SC injections every 4 weeks from the first administration until week 20 and then CNTO148 50mg SC injections every 4 weeks from week 16 until week 152

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with rheumatoid arthritis at least 3 months prior to registration and who are definitely identified as having rheumatoid arthritis, at the time of informed consent, according to the criteria for classification established by the American College of Rheumatology (1987)
* Patients in whom MTX therapy (\>= 6 mg/week) was started more than 3 months before the first administration and who have been treated with MTX at a stable dose (6-8 mg/week) for at least 4 weeks before the first administration
* Patients having at least 4 swollen joints and at least 4 tender joints at the time of registration and immediately before the first administration.

Exclusion Criteria:

* Patients with a history of hypersensitivity to human immunoglobulin proteins or other ingredients of golimumab
* Patients who have previously experienced or are suffering from any of the following diseases: (i) Collagen diseases other than rheumatoid arthritis, (ii) Latent or active granulomatous infections such as histoplasmosis and coccidioidomycosis, (iii) Felty syndrome, etc
* Patients with a severe, advanced, or poorly controlled disease in any of the kidney, liver, blood, gastrointestinal system, endocrine system, lung, heart, nervous system, psychiatric system, and brain.
Ultrasound IV Study

The purpose of this study is to compare catheter length and extravasation rates for Ultrasound (US)-guided peripheral intravenous (IV) catheter insertion in a subset of emergency department patients with difficult IV access. Physicians, Emergency RNs, and Emergency Technicians can be taught to use US guidance to start peripheral IV in the ED. The optimal length of catheter to use for this procedure is unknown. This study will provide data on the length of catheter required to minimize extravasation. There is no guideline on catheter length selection for US-guided peripheral vascular access. This study may decrease extravasation rates for US-guided peripheral vascular access by providing guidance on catheter length selection.

The purpose of this study is to compare catheter length and extravasation rates for US guided peripheral IV insertion in a subset of emergency department patients with difficult IV access. Physicians, Emergency RNs, and Emergency Technicians can be taught to use US guidance to start peripheral IV in the ED. The optimal length of catheter to use for this procedure is unknown. This study will provide data on the length of catheter required to minimize extravasation. There is no guideline on catheter length selection for US-guided peripheral vascular access. This study may decrease extravasation rates for US-guided peripheral vascular access by providing guidance on catheter length selection.

The study design is a randomized non-blinded clinical trial of extravasation rates of US guided peripheral vascular access related to intravenous catheter length and venous depth in the ED. Primary endpoint is duration of usable vascular access. Secondary endpoints are catheter length, venous depth, time of procedure, successful cannulation, reasons for failure, number of skin punctures, site of cannulation, sonographic technique, type of provider obtaining access and complications.

Eligibility Criteria:
Inclusion Criteria:

* two failed traditional IV attempts by a nurse
* need for IV access as determined by the treating physician
* age 18 and greater

Exclusion Criteria:

* less than age 18
* subjects needing a central venous catheter
* patients unable to provide informed consent
HIRREM Developmental Study

The purpose of this study is to explore the functional and physiological effects associated with the use of High-resolution, relational, resonance-based, electroencephalic mirroring (HIRREM), as supplemental care, for symptoms of neurological, cardiovascular, and neuropsychological disorders. This is a non-randomized, open label, and unblinded before-and-after trial, evaluating the effect of HIRREM on an objective, physiological common denominator (heart rate variability, HRV), across a variety of relevant conditions, as well as changes in clinical symptoms inventories, to generate hypotheses and pilot data for investigation in future proposals.


Eligibility Criteria:
Inclusion Criteria:

* Male and female adults and children aged 11 years and older.
* Subjects who are over the age of 18 must be able to give informed consent. Children must be able to sign an assent form and have a signed parental permission form.
* Subjects must have the ability to comply with basic instructions and be able to sit still comfortably with the sensor leads attached.
* Subjects previously diagnosed with a neurologic, cardiovascular, or psychophysiological disease such as attention deficit hyperactivity disorder, Asperger Syndrome, chronic pain, dyslexia, depression, insomnia, migraines, anxiety, PTSD, substance abuse disorder, traumatic brain injury, and others.

Exclusion Criteria:

* Subjects who fail to meet inclusion criteria.
* Subjects who are unable, unwilling, or incompetent to provide informed consent, assent and/or parental permission.
* Subjects physically unable to come to the study visits.
* Subjects with a known seizure disorder.
* Subjects with severe bilateral hearing impairment (HIRREM requires the use of headphones).
* Subjects receiving ongoing treatment with opiate, benzodiazepine, anti-psychotic or sleep medications, as well as some anti-depressants or stimulants, except those cases deemed acceptable by the principal investigator.
* Subjects with anticipated and ongoing use of recreational drugs except when deemed acceptable by the principal investigator.
Effects of One-handed and Two-handed Mask Ventilation Techniques on Global and Regional Lung Ventilation

Two-handed mask ventilation has been shown to provide higher tidal volume than one-handed mask ventilation. The effects of the two techniques on respiratory mechanics during induction of general anesthesia, however, still need to be determined.

Mask positive pressure ventilation always causes the changes of respiratory mechanics such as ventral redistribution of regional ventilation, which impairs gas exchange. Two-handed mask ventilation has been shown to improve gas exchange by providing higher tidal volume than one-handed mask ventilation. We hypothesis that those higher tidal volume caused by two-handed mask ventilation would also improve the respiratory mechanics during induction of general anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled for elective surgery with general anesthesia
* American Society of Anesthesiologist (ASA) physical class of I-II.

Exclusion Criteria:

* acute and chronic respiratory disorders, including chronic obstructive
* pulmonary disease (COPD) and asthma;
* a history of lung surgery;
* exist risk of reflux and aspiration;
* patients requiring an awake intubation;
* facial and thoracic deformities;
* implants exist in the body, such as cardiac pacemakers;
* pregnant women.
Benefits and Costs of Home-based Pulmonary Rehabilitation in Chronic Obstructive Pulmonary Disease

Pulmonary rehabilitation is an effective treatment for people with chronic obstructive pulmonary disease (COPD) which improves symptoms, reduces hospitalisation and lowers healthcare costs. However less than 1% of Australians with COPD receive pulmonary rehabilitation each year, due to poor access to programs and high levels of disability. This randomised controlled trial will examine the benefits and costs of a novel, entirely home-based pulmonary rehabilitation program for COPD. We hypothesise that home-based pulmonary rehabilitation can deliver equivalent clinical outcomes at lower cost than the centre-based program.

We will randomly allocate 144 people with COPD to undertake either standard pulmonary rehabilitation in a hospital setting, or a low-cost home-based program. Those who undertake pulmonary rehabilitation in the hospital setting will attend the hospital twice each week for eight weeks for supervised exercise training and education. People in the home pulmonary rehabilitation group will receive one home visit and weekly telephone calls for eight weeks, for supervision and mentoring of exercise and provision of education. We will compare the number of people who complete the program in each setting. We will also test whether the groups have similar results for the standard pulmonary rehabilitation outcomes of breathlessness, quality of life and exercise capacity, at the end of the program and 12 months later. We will compare health care costs and personal costs between groups after 12 months.

If home-based pulmonary rehabilitation can improve uptake of this important treatment, deliver good clinical outcomes and reduce costs this will have significant and long-lasting benefits for patients, the community and the health system


Eligibility Criteria:
Inclusion Criteria:

* current or former smokers of at least 10 packet years
* aged 40 years or over
* diagnosis of COPD confirmed on spirometry.

Exclusion Criteria:

* previous diagnosis of asthma
* have attended a pulmonary rehabilitation program in the last two years
* exacerbation of COPD within the last four weeks
* have comorbidities which prevent participation in an exercise training program
Examining the Effects of a Mobilization With Movement and a Dynamic Stretch With Over Pressure on Hip Flexion.

The purpose of this study is to compare the effects of a mobilization with movement (MWM) technique performed by a physical therapist with those of a dynamic stretch with over pressure on active hip flexion range of motion (ROM) in those with active hip flexion ROM limitations. There is limited evidence available in the literature examining the therapeutic effects of MWM at the hip, the long term effects of MWM, or whether one modality is more effective than another. This study seeks to address these gaps in the literature by directly comparing the results of these two manual therapy interventions on active hip flexion ROM.

This study aims to compare the effects of a therapist-performed mobilization with movement (MWM) technique with those of a dynamic stretch with over pressure on active hip flexion range of motion (ROM) in those with active hip flexion ROM limitations.Those individuals from the University of South Carolina's Department of Physical Therapy (UofSC DPT) community who are interested in becoming study participants will be identified by means of announcements made in the Seminar in Physical Therapy course which is attended by all students, faculty, and staff of UofSC DPT each week. Interested individuals will be provided with Cathy Arnot's email address in order to schedule an evaluation session to determine whether or not they meet the study's inclusion and exclusion criteria. In addition, Sarah Cooper will attend a staff meeting at Vertex PT Specialists to make an announcement and provide the attendees with Cathy Arnot's email for inquiries. Participants will be assigned to either the MWM group or the dynamic stretch with over pressure group via blocked randomization for sex and age, with at least seventeen participants being placed into each group. The MWM group participants will receive a therapist-performed MWM technique and a prescription for a home exercise program (HEP) consisting of a dynamic stretch with over pressure to be performed once a day over the course of the following week. The dynamic stretch with over pressure group participants will receive only the prescription for the HEP consisting of the dynamic stretch with over pressure to be performed once a day over the following week. Measurements will be assessed at four time points: Immediately before the intervention, immediately after the intervention, 24 hours after the intervention, and one week after the intervention.

Eligibility Criteria:
Inclusion Criteria:

* The sole inclusion criterion will be a limitation in hip flexion to less than 101 degrees in both hips.

Exclusion Criteria:

* Any traumatic injury to or surgical procedure performed upon the lower extremities within the last six months
* Any contraindication to dynamic stretching, weight-bearing rotation, or MWM of the hip joint
* Any dermatologic pathology in the area of the strap application
* Any pain provoked by active hip flexion.