cyrilzakka/clinical-trials huggingface dataset:
Enhancing Quality of Informed Consent (EQUIC-DP) Developmental Phase

Patients in 'parent' cooperative studies projects are interviewed about their experiences in the informed consent process.

Intervention: Immediately after giving informed consent for the parent study and before randomization, research subjects will be asked for consent to participate in EQUIC-DP.

The parent-study staff will provide the research subject with privacy and place a call to the coordinating center. Staff (at the EQUIC coordinating center), who will be administering the Brief Informed Consent Evaluation Protocol (BICEP) to the research subject, will introduce themselves. Then, the subject will be interviewed using a BICEP structured assessment questionnaire of approximately 12-20 open ended questions, aimed at determining the success and validity of the informed consent process of the parent study. The results of the interviews will be used to fine-tune and adjust both the process of assessing informed consent in this manner as well as the questionnaire itself.

Primary Hypothesis: Enhancing the Quality of Informed Consent Development Phase (EQUIC-DP) is a pilot and instrument-development study that will be used as the base for a VA Cooperative Studies Program-wide initiative on informed consent, called EQUIC (Enhancing the Quality of Informed Consent). EQUIC-DP has as its primary aim the field testing and iterative improvement of a method for measuring the success of an informed consent encounter with a patient-subject.

Primary Outcomes: The quality of the informed consent process, as measured by the BICEP (Brief Informed Consent Evaluation Protocol). The BICEP also offers a method to certify informed consent in routine use.

Study Abstract: Practitioners of clinical trials have a responsibility to ensure that patients participation in research is informed and voluntary. This implies that we should continuously strive to improve the effectiveness of methods for informing prospective research volunteers about experimental studies, thereby enhancing the likelihood that their interests are respected. Innovations in informed consent should be tested in realistic contexts (i.e., in clinical trials) and when appropriate with randomization at the first opportunity. In this proposed project we take efforts to improve the quality of informed consent, based on experimentation with informed consent in ongoing clinical trials in the VA Cooperative Studies Program. The CSP is uniquely situated to serve as a testing ground for informed consent, not only because of concerns for enhancing consent for human experimentation, but also because of the centralized coordination of wide variety of clinical studies representing an extraordinary range of patient capacities and vulnerabilities. Moreover, such an effort is a special responsibility of the VA given the profound trust placed in the research enterprise by veterans.

Eligibility Criteria:
Inclusion Criteria:

Depends on 'parent' study

Exclusion Criteria:
Association of Periodontitis and Preeclampsia During Pregnancy

Infections affecting the mother during pregnancy may produce alterations in the normal cytokine and hormone-regulated gestation, which could result in preeclampsia, preterm labor, premature rupture of membranes, and preterm birth. Therefore, pregnant women with periodontal disease may show an alteration in the cytokine levels which may cause preeclampsia in them.

The enrolled subjects will be evaluated on the basis of a pre-designed and pre-tested proforma with respect to history and clinical examination, obstetrics examination and ultrasonography. The periodontal examination consists of assessments at vestibular, lingual, mesial and distal sites of all present teeth.Five ml venous blood sample will be drawn from the patient at the time of enrollment before 20 weeks of gestation for the levels of cytokines (IL-4, IL-10, IFN-g and TNF-α. All the subjects will be followed- up till delivery. At the time of delivery, the details of pregnancy outcome (maternal and fetal) along with the measurement of the blood pressure will be recorded. A repeat of oral health evaluation will be done within 48 hours of delivery.

Eligibility Criteria:
Inclusion Criteria:

* Singleton live pregnancy.
* Sure of her dates. (known dates of the last menstrual period)
* Age group 18-35 years.

Exclusion Criteria:

* Chronic hypertension
* Polyhydramnios
* Congenital malformation in fetus
* Diabetes
* Renal disease
* Cardiovascular disease
* Urolithiasis
* Parathyroid disease
* Systolic blood pressure measurement of more than 140mm Hg and diastolic blood pressure more than 90 mm Hg at first visit.
* Infections (bacterial vaginosis and chorioamnionitis)
* Antibiotic use during pregnancy
* Excessive body mass index
* Less than 20 natural teeth
Interventions to Reduce Loneliness in Elderly Patients in the Cardiac ICU (CICU)

This clinical trial aims to study whether patient-tailored interventions can reduce loneliness levels in elderly patients admitted to the Cardiac ICU (CICU). The study will involve an experimental group that will receive tailored interventions based on their needs and preferences, and a control group that will receive standard care. The primary goal of the trial is to determine if patient-tailored interventions can effectively reduce loneliness in patients staying in the CICU. The trial is interventional in nature and will compare results between the two groups.

This interventional clinical trial is designed to investigate the effects of patient-tailored interventions on reducing loneliness levels in elderly patients admitted to the Cardiac ICU (CICU). The aim of this study is to determine if tailored interventions can improve the well-being and quality of life of elderly patients who experience loneliness during their stay in the hospital.

The primary research question is: Could patient-tailored interventions be used to reduce loneliness in patients staying in the CICU? The study will involve two groups of participants: an experimental group that will receive tailored interventions and a control group that will receive standard care.

Participants in the experimental group will receive tailored interventions by CICU staff based on their expressed needs and preferences. The interventions will be personalized to the individual patient and will be individualized based on survey responses from patients in the experimental group. The interventions will be implemented throughout the patient's stay in the CICU.

The control group will receive standard care, which includes medical treatment and monitoring, but will not receive any patient-tailored interventions aimed at reducing loneliness levels.

Eligibility Criteria:
Inclusion Criteria:

* patients who were able to communicate effectively and cooperate with staff members
* patients who had stayed in the CICU for a minimum of 48 hours
* patients who met the age criteria of being over 70 years old

Exclusion Criteria:

* patients under the age of 70 years old
* patients who were unconscious or on ventilators
* patients who were admitted immediately after surgery
* patients with hemodynamic and/or respiratory instability
* patients with cognitive impairments, such as dementia and/or Alzheimer's disease
Study to Evaluate the Leish-111F + MPL-SE Vaccine in the Treatment of Cutaneous Leishmaniasis

This study will evaluate the safety of the Leish-111f + MPL-SE vaccine in adult patients with cutaneous leishmaniasis.

Cutaneous leishmaniasis is a disfiguring infection that can progress to mucosal leishmaniasis, a more serious and possibly fatal form of leishmania infection. All available medical therapies require weeks of treatment and cause significant toxicity. In Brazil, a standard therapy is Glucantime treatment, administered in cycles of 10 consecutive, once daily, intramuscular injections (Glucantime 10 mg/kg, maximum of 850 mg), followed by 11 consecutive days without Glucantime injections (rest days). At the completion of each cycle, a study physician examines the patient to determine if a further cycle of Glucantime treatment is indicated.

It appears that Leishmania infections can be eliminated by T helper 1 immune responses. This finding argues that a vaccine that augments cutaneous leishmaniasis patients' T helper 1 response will eliminate the infection and disease. This study is a phase 1, randomized, double-blind, placebo controlled, sequential dose-escalating trial to evaluate the safety and immunogenicity of three injections of 5, 10, or 20 μg of Leish-111f protein + 25 μg of MPL-SE adjuvant given at 4 week intervals as an adjunct to the standard chemotherapy with Glucantime cycles, as described above in patients with cutaneous leishmaniasis.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of cutaneous leishmaniasis defined as positive identification of parasite from lesion biopsy
* Normal lab values and electrocardiogram (ECG)
* Negative for HIV, hepatitis B and C, and Chagas disease

Exclusion Criteria:

* Nine or more active cutaneous lesions
* Lesion diameter \>60mm
* Previous exposure to Leishmania vaccines or to MPL-SE
* Pregnant or breastfeeding female
The Role of Early Rehabilitation in Improving Stroke Systems of Care

1. To assess the effect of implementing stroke early rehabilitation using telemedicine if avialable in the stroke unit of the Neurology Department , Assuit university hospitalis , Egypt.
2. Importance and impact of this programme on function and quality of life after stroke

In this case control study,we will analyzed Patients admitted to Neurology Depatment in assuit university hospitals from 1/2023 until 1/2024 and divide them in two groups , Group receive early rehabilitation services with the personnel get tele-rehab training and the other group get training with the usual pathway in the hospital by other personnel, and we could follow up the two groups for 3 months and comparing both groups .

Eligibility Criteria:
Inclusion Criteria:

1. Mild to Moderate stroke Patients (ischemic or hemorrhagic) admitted to AUH within 24 hour after admission.
2. ALL age Groups .
3. Both Sex.
4. Group receive rehab services with the personnel get tele-rehab training and the other group get training with the usual pathway in the hospital by other personnel, and we could follow up the two groups for 3 months and comparing both groups .

Exclusion Criteria:

Severe Stroke.

* Stroke Mimmics .
* Pregnancy.
* Stroke with severe hepatic ,renal and Pulmonary diseases limiting or affecting early rehabilitation .
The Effect of Gait Training Using Virtual Reality and Real-Time Feedback on Physiological and Functional Gait Performance in Persons With a Traumatic Lower Extremity Amputation

To assess the carryover effect of an innovative new gait training program on physiological and functional gait performance in persons with a traumatic lower extremity amputation. A second objective is to clarify the relationship between gait biomechanics (joint and sgment kinematics and energy cost.


Eligibility Criteria:
Inclusion Criteria

* Unilateral traumatic trans-tibial or transfemoral amputation
* Independent ambulation without an assistive device for a minimum of three months
* Ability to ambulate continuously for a minimum of 15 minutes
* Trans-femoral participants must use an ischial containment socket
* VAS Pain scores on the involved side of less than 4/10
* Sagittal plane ankle, knee and hip strength of 4 or greater on the uninvolved side as determined by manual muscle test.

Exclusion Criteria:

* Blindness
* TBI-Glascow Coma Scale score of 12 or lower at the time of injury
* Cardiac or pulmonary problems limiting physical activity PTSD or other psychological condition with symptoms that would be exacerbated by participation in the study.
Combined Intravitreal Injection of Bevacizumab and Fasudil Versus Bevacizumab Alone for Macular Edema Secondary to Retinal Vein Occlusion in Previously Treated Patients

This study is aimed to compare the effect of combined intravitreal Bevacizumab and Fasudil injection with Bevacizumab only injection in patients with persistant macular edema secondary to ratinal vein occlusion.

Methods:

In this study patients with retinal vein occlusion patient who had at least three or more intravitreal AntiVEGF injection with persistence of macular edema at funduscopic examination is recruited. The eligible patients in randomized in two groups "Bevacizumab" and "Bavacizumab + Fasudil" and in injected intravitreally for 3 times monthly. In "Bevacizumab+Fasudil" group patients receive two injections at each session Bavacizumab and Fasudil. In "Bevacizumab" group patients receive only Bevacizumab. The patients are followed for 6 months and central macular thickness and visual acuity is measured at baseline and monthly for 6 month. Baseline ancillary exams include Fluorescein Angiography and OCT-Angiography which is performed at the final exam as well. Patients needing any therapeutic intervention is addressed during the 6 month follow up period.


Eligibility Criteria:
Inclusion Criteria:

* Branch retinal vein or central retinal vein occlusion Previous at least 3 intravitreal antiVEGF injection Macular edema in SD-OCT CMT = \>250 microns BCVA equal or lesd than 20/40

Exclusion Criteria:

* Moderate or severe corneal opacity Significant cataract obscuring retinal exam or OCT Glaucoma History of vitreoretinal surgery Diabetic retinopathy Macular disease (AMD,ERM,VMT Kidney or Liver disease Uncontrolled or moderate or severe Anemia Uncontrolled hypertention
Emergency Classification According to Fingertip Circulation

Dyspnea is one of the most common reasons for admission to the emergency department\[1\]. Oxygen saturation has great importance in determining the triage status of patients admitted to the hospital with dyspnea and planning the emergency treatment \[2\].

Peripheral perfusion index (PI), which shows tissue oxygenation is a noninvasive way of demonstrating tissue perfusion in critically ill patients. Studies have shown that PI is an accurate, fast and reliable pulse oximetry-based indicator of tissue perfusion \[3-5\]. PI shows the perfusion status of the tissue in the applied area for an instant and a certain time interval. The PI value ranges from 0.02% (very weak) to 20% (strong) \[6\].

Triage scales are used to distinguish emergency and non-emergency patients. The emergency triage system is used to quickly determine the care priorities of patients during admission to the emergency department\[7,8\].

It is important to make the triage classification for dyspnea in emergency services quickly and accurately to start the treatment protocols as early as. In this study, the investigators aimed to determine the relationship between perfusion index and the emergency triage classification in patients admitted to the emergency department with dyspnea.

Purpose: To determine the effect of PI measurement on the emergency triage classification in patients with dyspnea.

Methods: Adult patients who presented with dyspnea and whose perfusion index values were measured with Masimo Radical-7 device at the time of admission, at the first hour and the second hour of admission were included in the study. The PI and oxygen saturation measured by finger probes were compared and the superiority of their effects on the emergency triage classification was compared.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients over the age of 18 who presented with dyspnea
* whose perfusion index values were measured at the time of first admission (arrival time), at the first hour and the second hour of admission were included in the study

Exclusion Criteria:

* Patients who applied due to the mechanism of trauma,
* patients with known vascular disease (Buerger's disease, peripheral artery disease, etc.), -patients with COVID-19 PCR positivity
* whose perfusion index measurement could not be completed due to hospitalization or discharge were excluded from the study.
Effects of Perioperative Systemic Ketamine on Development of Long-term Neuropathic Pain After Thoracotomy

Lung surgery under thoracotomy is known to induce long-term pain which can be considered as neuropathic in many patients concerned \[1,2\]. The suspected origin of neuropathy is a direct traumatism of intercostal nerve(s) \[3\]. Among the possible preventive treatments that can be administered during the initial aggression, ketamine \[4,5\] appears as the easiest to use, as it is already commonly administered intra and postoperatively for improvement of analgesia \[6\].

Lung surgery under thoracotomy is known to induce long-term pain which can be considered as neuropathic in many patients concerned \[1,2\]. The suspected origin of neuropathy is a direct traumatism of intercostal nerve(s) \[3\]. Among the possible preventive treatments that can be administered during the initial aggression, ketamine \[4,5\] appears as the easiest to use, as it is already commonly administered intra and postoperatively for improvement of analgesia \[6\]. This study compares two groups of patients undergoing thoracotomy for partial pneumonectomy, one receiving intravenous ketamine since the beginning of procedure and then during 48 hours, the other receiving inactive normal saline (placebo). The study is prospective, randomized, and double-blinded. The primary endpoint is to reduce chronic pain (on visual analogue scale) at the 4th month after surgery with ketamine. The objective is to obtain a mean value under 20/100 in the ketamine group, considering that the expected mean value for the control group is 38/100 (based on personal observations). The secondary endpoints are lower scores of neuropathic pain in the ketamine group, assessed by the NPSI questionnaire \[7\]. The impact of treatment on quality of life, assessed by a questionnaire (SF-36), is also studied. The data collected by clinical and psychophysical examination performed on all patients at the 4th month after surgery will be also considered for analysis, in order to understand better the features of post-thoracotomy neuropathic pain.

Eligibility Criteria:
Inclusion Criteria:

* elective partial pneumonectomy under lateral or posterolateral thoracotomy, performed under standardized general anesthesia.

Exclusion Criteria:

* Patient's refusal
* Bad health status
* Previous neuropathic pain or treatment acting on neuropathic pain
* Major postoperative complication
* Intolerance to ketamine
* Epidural anesthesia
Nursing Students' Visits to Older Adults With Multiple Chronic Conditions

BACKGROUND

The concurrence of multiple chronic conditions in older adults is associated with increased healthcare expenditure, increased hospital admissions, consultations and pharmaceutical expenditure. Having been diagnosed with multiple chronic conditions is associated with biopsychosocial health deterioration, worsening quality of life and increased mortality in older adults. Consequently, older adults with multiple chronic conditions present complex health statuses that require healthcare professional to focus on promoting health and independence through self-care.

Available evidence suggests that the implementation of programs with individualized interventions focused on health promotion could improve self-care and other related variables in older people with chronic conditions. In this regard, the World Health Organization recommends the implementation of community health promotion programs including at least 5 home-visits carried out by healthcare professionals to promote self-care, independence, and quality of life amongst older adults with chronic conditions. However, the evidence on the cost-effectiveness of such visiting programs is inconsistent, which makes it difficult to integrate them into the services offered by public-funded healthcare systems. In search of more effective interventions to improve self-care and other related variables amongst older adults with multiple chronic conditions, nursing student visits could be a valid, effective alternative. Some studies suggest that the implementation of periodic follow-up programs (visits or telephone calls) by nursing students not only improves their knowledge and attitudes in relation to the care of older adults, but they could also have a positive impact on patients.

STUDY'S HYPOTHESIS

A program of supervised visits carried out by nursing students will significantly improve self-care behaviors and other related variables amongst older adults with multiple chronic conditions.

AIM

The aim of the VISITAME project is to examine the short-term (12 weeks) and medium-term (6 months) effects of a nursing students' home-visit programme on self-care behaviors amongst older adults with multiple chronic conditions.

STUDY DESIGN

A parallel two-arm randomized controlled trial (RCT) will be carried out. Participants will be randomly assigned to either an intervention group (IG) or a control group (CG).


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 65 years.
* Having been diagnosed with more than one chronic condition.
* Living at home (community-dwelling).
* Signing the informed consent to participate in the study.

Exclusion Criteria:

* Having cognitive impairment (Pfeiffer test \> 2 failures).
* Having been diagnosed with a psychiatric condition (for example: schizophrenia).
* Being a beneficiary of any of the services offered by the Fund of the Spanish National System for Autonomy and Support for Dependency.
* Being a beneficiary of private personal assistance to help with functional dependency.
* Participate in a program of similar nature from any public or private entities.
Effect of a Self-care Intervention on Depression in People With Age-related Macular Degeneration or Diabetic Retinopathy

The purpose of this trial is to determine the short-term effect of a self-care intervention on depression in patients with age-related macular degeneration or diabetic retinopathy.


Eligibility Criteria:
Inclusion Criteria:

* clinical diagnosis of wet or dry AMD or diabetic retinopathy
* age 50 years and older
* at least mild depressive symptoms (a score of 5 or more on the PHQ-9)
* no legal blindness (visual acuity better than 20/200 in better eye).

Exclusion Criteria:

* the current use of cognitive behavioural therapy
* suicidal intent
* ocular surgery during the study period (intravitreal anti-VEGF injections will be allowed, e.g. Lucentis)
* cognitive impairment
* inability to speak and understand French or English
* profound hearing impairment.