cyrilzakka/clinical-trials huggingface dataset:
Early Sensory Re-education of the Hand With a Sensor Glove Model

The implementation of early sensory re-education (SR) techniques, aimed to preserve the cortical hand area, such as the use of audio-tactile interaction, becomes an important strategy to obtain also a better sensory function. The aim of this study was to investigate sensory function outcomes (threshold monofilaments, two-point discrimination test, STI and DASH) and cortical responses (fMRI) in patients submitted to an early protocol of SR of the hand with a sensor glove model. After surgical repair of median and/or ulnar nerves, 17 participants were divided into two groups: the training group, trained on the protocol with the sensor glove model, and the control group, untrained. After six-month follow-up, no difference was observed between groups, related to sensory function, especially tactile gnosis. Despite this, the early training with this sensor glove model seems to provide some type of cortical audio-tactile interaction, contributing to previous studies that focus in early SR of the hand using the integration of different sensory modalities.


Eligibility Criteria:
Inclusion Criteria:

- Injury of the ulnar and/or median nerves at the wrist or distal forearm level surgically repaired

Exclusion Criteria:

* Neurological diseases
* Systemic diseases, which affected either directly or indirectly the central or peripheral nervous system
* Extensive traumas in the upper limbs
Excessive Warfarin Anticoagulation - Causes and Consequences

The aim of this study is to investigate the clinical significance of high INR (International Normalized Ratio) values (\>9) in VKA (vitamin K antagonist) treated patients with atrial fibrillation. The clinical characteristics of these patients will be studied as well as the clinical presentation. Factors influencing on high INR values will be recorded and the aim is to seek out patients who have elevated risk of bleeding complications.

This is a retrospective study setting. Source data will be collected by reviewing medical records and through computer searches. The basic study population will be identified from laboratory INR test results taken between 2003-2015.

Identifying patients with INR values over 9 will be selected for further analysis, concerning the clinical presentation, patient characteristics, 90 day survival and adverse event rates. The focus is in identifying patient characteristics and factors influencing the risk of high INR value. Also we will analyse the effects of medically reversing the high INR values on stroke and other adverse event rates. The results will be collected manually using an electronic case report form, and analysed statistically using SPSS/SAS statistics tool.

Eligibility Criteria:
Inclusion Criteria:

* VKA treatment, age \> 18, INR \>9,

Exclusion Criteria:

* age \< 18
EXPLORATORY STUDY Addendum to INVAC1-CT-101 (NCT02301754)

This study will be an exploratory study of long term immunogenicity of INVAC-1 in patients who participated in the INVAC1-CT-101 phase I study (between 2014 and 2018).

The primary goal of the study is to analyze anti-telomerase specific memory responses in blood of long term survival patients and to correlate these immune responses to their subsequent treatment since the end of INVAC1-CT-101 phase I study. Six patients are expected to participate in this study.

Eligibility Criteria:
Inclusion Criteria:

1. Patients who participated in the phase I study and are still alive at the present time
2. Ability to provide written informed consent and to understand and comply with the requirements of the study.

Exclusion Criteria:

1. Anemia (Hgb \< 7g/dL) according to L-1121-1 annexe 2 of Code de Santé Publique
2. Systolic blood pressure below 90 mm Hg
Ocular Comorbidity in Atopic Dermatitis

A clinical characterization of a large cohort of patients with different severities of AD and ocular symptoms/atopic keratoconjunktivitis (AKC). The data will contribute to assess the frequency of complications in order to give a rationale for focused prevention and treatment strategy.

Atopic Dermatitis (AD), a very common inflammatory skin condition of child and adulthood, is strongly associated with ocular disease. Accordingly, about 20% experience conjunctivitis at some point, and many have chronic disease. Atopic keratoconjunctivitis (AKC) is the most feared as it may lead to blindness. Little is known about the etiology, the immune infiltrate, as well as predictive factors of AKC and the clinical characteristics of AD patients who develop this entity. We expect this project to enable clinicians to better identify AKC patients in the future as well as improve the understanding of the pathogenesis of AKC.

The ocular findings will be compared between AD severity and a control group without ocular symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Danish talking
* Diagnosed with atopic dermatitis (AD)
* Current or previous ocular symptoms suspected to be atopic keratoconjunctivitis

Exclusion Criteria:

* No pause in eyedrops
* Ocular infections within the last 3 months
* Use of local or systemic antibiotics within the last 3 months
* Significant untreated systemic disease such as hypertension, heart failure, diabetes mellitus, previous cerebral infarction or bleeding, lung diseases and autoimmune diseases other than atopic dermatitis and related comorbidities. The diseases are accepted if they are well treated or do not require treatment
* Current pregnant or breastfeeding
* Use of contact lenses, unless these are paused 2 weeks before the examination or they are due to keratoconus treatment
* If the eye symptoms turn out not to be related to atopic keratoconjunctivitis
* If it is assessed that the individual cannot participate sufficiently for the examination
Trial to Study the Adjuvant Benefits of Quercetin Phytosome in Patients With COVID-19

The purpose of this study is to investigate if Quercetin Phytosome is beneficial for the treatment of COVID-19.

This is a randomized, open-labelled and controlled study aimed to investigate the adjuvant benefits of Quercetin Phytosome in community-based subjects with confirmed SARS-CoV-2 infection (by RT-PCR). The study has two arms. In one arm the subjects will receive standard COVID-19 care as per the hospital/physician guidelines, whereas in the other arm the subjects will receive standard COVID-19 care + Quercetin Phytosome. The treatment will continue for 30 days. It is proposed that Quercetin Phytosome will contribute to boosting the natural immunity of the subjects and will help in preventing the COVID-19 disease progression i.e preventing the need of hospitalisation.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years of either gender
* Confirmed SARS-CoV-2 infection by RT-PCR
* Currently diagnosed with mild-to-moderate symptoms of COVID-19 at home in self-isolation within 3 days of SARS-CoV-2 infection.
* Displaying typical symptoms of COVID-19 such as a high temperature, a new, continuous cough, a loss or change to sense of smell or taste
* Patients who have signed informed consent.

Exclusion Criteria:

* Patients with proven hypersensitivity or allergic reaction to quercetin
* Manifest contrary will
Prognostic Value of NLR, TLR, and ALC in Predicting ToF Primary Repair Outcome

Tetralogy of Fallot (ToF) were cyanotic congenital heart disease with chronic hypoxia which increases the risk of exacerbated inflammatory response in ToF primary repair. Various studies have recently shown inflammatory biomarkers to predict morbidity and mortality in hypoxemic patients, but they are not readily available and expensive.This study aims to compare the prognostic value of neutrophil-lymphocyte ratio (NLR), absolute lymphocyte count (ALC), and thrombocyte-lymphocyte ratio (TLR) in predicting ToF primary repair outcomes. This was a retrospective observational study on ToF primary repair in National Cardiovascular Center Harapan Kita between Januari 2020 until December 2022. Preoperative NLR, ALC, and TLR were derived from blood test obtained \<14 days before surgery. The primary endpoints were redo surgery, 30-day mortality, and complications. The secondary endpoints were hospital length of stay (HLOS) and postoperative LOS.

This was a retrospective observational study on tetralogy of Fallot (ToF) primary repair in National Cardiovascular Center Harapan Kita between Januari 2020 until December 2022. The preoperative demographic data included were patients' gender, age, weight, oxygen saturation, and associated diagnosis other than ToF. The preoperative data of complete blood count and differential count must be tested from the most recent peripheral blood samples taken no later than 14 days before the surgery. The data obtained were the number of days of the most recent blood test including the leukocyte count, percentage neutrophil, percentage and absolute lymphocyte count, thrombocyte count, as well as the derived variables such as neutrophil lymphocyte ratio (NLR) ratio and thrombocyte lymphocyte ratio (TLR). The intraoperative data included were the use of cardiopulmonary bypass (CPB), CPB time, aortic cross-clamp (AOX) time, and the total duration of surgery. Patients were evaluated and followed-up for any complications and postoperative mortality during the same hospital stay until discharge. Patients were then followed up for any cause of mortality within 30 days postoperative.

Eligibility Criteria:
Inclusion Criteria:

* All patients with ToF and any other associated cardiac anomalies, who underwent ToF primary repair and had a complete blood cell count with differential count available preoperatively

Exclusion Criteria:

* Surgery other than ToF primary repair
* Association with other procedures (except patent ductus arteriosus/PDA ligation, patent foramen ovale/PFO or atrial septal defect/ASD closure, or pulmonary arteries enlargement)
* Preoperative hemodynamic instability
* Suspected or confirmed infection with prior antibiotic administration during the same hospital admission
* Absence of complete blood count with differential count
Implementation of Neuro Lung Protective Ventilation

Patients who experience lung injury are often placed on a ventilator to help them heal; however, if the ventilator volume settings are too high, it can cause additional lung injury. It is proven that using lower ventilator volume settings improves outcomes. In patients with acute brain injury, it is proven that maintaining a normal partial pressure of carbon dioxide in the arterial blood improves outcomes. Mechanical ventilator settings with higher volumes and higher breathing rates are sometimes required to maintain a normal partial pressure of carbon dioxide. These 2 goals of mechanical ventilation, using lower volumes to prevent additional lung injury but maintaining a normal partial pressure of carbon dioxide, are both important for patients with acute brain injury. The investigators have designed a computerized ventilator protocol in iCentra that matches the current standard of care for mechanical ventilation of patients with acute brain injury by targeting a normal partial pressure of carbon dioxide with the lowest ventilator volume required.

This is a quality improvement study with the purpose of observing and measuring the effects of implementation of a standard of care mechanical ventilation protocol for patients with acute brain injury in the iCentra electronic medical record system at Intermountain Medical Center. We hypothesize that implementation of a standardized neuro lung protective ventilation protocol will be feasible, will achieve a target normal partial pressure of carbon dioxide, will decrease tidal volumes toward the target 6 mL/kg predicted body weight, and will improve outcomes.


Eligibility Criteria:
Inclusion Criteria:

1. Acute brain injury due to non-traumatic causes (stroke, spontaneous intracranial hemorrhage, cerebral edema, anoxic brain injury) or traumatic brain injury.
2. Initiation of mechanical ventilation in the emergency department or intensive care unit at an Intermountain Healthcare hospital
3. Age ≥ 18 years

Exclusion Criteria:

1. Transition to comfort care in the emergency department or on the same day of admission to the ICU
2. Death on the same day of admission to the emergency department or ICU
HIV Treatment-Readiness Measure (HTRM) Validation

The goal of this study is to assess the reliability of the HIV

Treatment Readiness Measure (HTRM) to assist clinicians in:

(1) determining whether or not youth living with HIV are ready to initiate HAART and (2) identifying youth who may be in need of additional support services to facilitate their adherence to HAART. The current study will examine the psychometric properties of the HTRM and establish its test-retest reliability over a two week period. If the HTRM is found to be reliable, a subsequent study will examine its predictive validity.


Eligibility Criteria:
Inclusion Criteria:

* HIV-positive youth, 13 years 0 days to 24 years 364 days of age
* Either HAART naïve (defined as never having taken HAART) or HAART experienced (defined as having had at least one experience taking HAART and not having taken HAART for 30 days prior to study entry)
* Not currently on HAART, but planning to initiate HAART within the next 2 months based on provider recommendation
* Enrolled in care at an AMTU or a collaborating site
* Able to speak and understand English
* Willing to provide informed consent, or assent with parental permission (if required by the site IRB) for participation in this study.

Exclusion Criteria:

* Evidence of cognitive impairment or other mental condition that limits his/her ability to complete the assessment (per PI or designee discretion)
* Determined by the PI (or designee) to be under the influence of psychoactive agents or intoxicated at the time of assessment to a degree that would interfere with successful completion of the questionnaire
* Visibly distraught or unstable
* Any clinical condition that would likely interfere with the participant's ability to complete the study

Participants who are unable to speak English will be excluded from the initial testing of the HTRM's reliability and validity in keeping with traditional tool development strategies. If the initial study indicates that the English version of the HTRM is reliable and valid, appropriate methods will be employed to translate the instrument into Spanish and the reliability and validity will be re-examined for the Spanish version.
Development and Evaluation of the DEA App

Background, current situation, and motivation

According to current estimates, 100,000 people in Austria suffer from various types of dementia. According to forecasts, this number of people will rise to approximately 230,000 by 2050 due to the demographic development and the increase of the prevalence rate. Data from the service statistics show that 85% of dementia patients still live in the community in their homes and informal caregivers, such as relatives, support them. In total, more than 300,000 people care for their relatives in Austria in addition to professional support. However, not only the person affected from dementia suffers from the disease, but also, and often at a higher rate, the informal caregivers. Vice versa, the quality of life of those suffering from dementia is significantly influenced by the caregivers' competences and their strategies for resilience.

Study aim and hypothesis

The aim of this study is to evaluate the usability, acceptance, and effect of an app consisting of three modules that provide multidimensional support for informal caregivers of a person with dementia.


Eligibility Criteria:
Inclusion Criteria:

* informal caregivers of a person with dementia
* 18 years or older
* enough language skills to participate
* give written and oral informed consent
* have an Android smartphone or tablet (required to use the app).

Exclusion Criteria:

* none
Impact of Zinc Supplementation on Mortality and Hospitalizations in Children Aged 1 Months to 23 Months

Children, aged 1 months to 23 months, in the intervention households received zinc, iron and folic acid and those in the control households were administered iron and folic acid (IFA) alone for a period of one year. The primary outcomes were hospitalizations and deaths during this period.

Objective: Studies in developing countries show substantial reduction in diarrhoea and respiratory morbidity in young children receiving zinc supplementation. The impact of daily zinc supplementation coadministered with iron folic acid in young children on all cause hospitalisation and mortality in comparison with iron folic acid alone, was evaluated to help shape public policy.

Design: Randomised double blind trial

Setting: Low to middle socio-economic urban neighbourhoods of north and north-west Delhi in India

Participants: 94359 subjects aged 1 month to 23 months

Interventions: The subjects were administered dispersible tablets containing one recommended daily allowance of zinc and iron folic acid or iron folic acid alone, daily for 12 months after enrolment.

Main outcome measures: Hospitalisations were captured through passive surveillance of eight hospitals by trained study physicians. Deaths were ascertained through bimonthly visits to households.

Results: A third of the total children had low zinc levels (\<60 mg/dL) and one fourth had iron deficiency (haematocrit \<33%) at baseline. The proportion zinc deficient was significantly lower post 12 months supplementation, in the zinc and iron folic acid group (difference in proportions -10%; 95% confidence interval -15.6% to -4.4%, p 0.0005). Only 7.7% in the zinc and iron folic acid and 7.3% in the iron folic acid group had low haematocrit. Zinc and iron folic acid supplementation had no impact on hospitalisations, overall and cause-specific. The overall death rates were similar in the two groups.

Conclusions: The lack of mortality impact may be real or the findings could have resulted from the use of lower daily zinc dosing than in morbidity prevention trials or an interaction between zinc and iron whereby adding iron, may have adversely affected potential effects of zinc on immune function and morbidity. Future research should address iron and zinc interaction effects on important functional outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Age 1 months to 23 months
* Either sex
* Resident of study area

Exclusion Criteria:

* Likely to leave the area during the study period
* Non consent
* Temporary exclusion criteria Illness requiring hospitalization Visible severe wasting. Visibly wasted children will be referred to a hospital for treatment. They will be eligible for enrollment only after effective rehabilitation.
Efficacy of Provex CV Supplement to Reduce Inflammation Cytokines and Blood Pressure

The purpose of this study is to determine if a supplement called Provex CV can reduce blood pressure and other risk factors for heart disease. Heart disease is the leading cause of death in this country and it is important to identify dietary factors, including supplements, that can reduce heart disease risk factors. The supplement to be tested in this study is made of a combination of natural compounds found in plants such as grapeseed extract, green tea, and quercetin. Each compound individually has been shown to improve blood pressure or reduce inflammation. We hypothesize that Provex CV will reduce blood pressure and levels of inflammatory cytokines hypertensive patients with symptoms of metabolic syndrome. This investigational trial of Provex CV has been approved by the United States Food and Drug Administration.


Eligibility Criteria:
Inclusion Criteria:

* Males (18 - 65) and postmenopausal females (up to age 65) with metabolic syndrome who have stage 1 hypertension.
* Since all subjects will have Stage 1 hypertension, they must also meet at least 2 of the following criteria of metabolic syndrome to qualify for the study; waist circumference of \>35 inches for women or \>40 inches in men, fasting plasma triglycerides of \>150 mg/dl, fasting glucose of \>100 mg/dl, HDL of \<40 in men. Pre-hypertension or greater (130 + mm Hg systolic/80+mm Hg diastolic) is defined by the 7th Report for the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure.

Exclusion Criteria:

* Subjects who are allergic to tea or grapes (on which the supplement is based).
* Participants who have blood pressure less than 130 mmHg / 80 mmHg,
* have a history of a prior cardiovascular event, diabetes, pregnancy, liver disease, renal insufficiency, any chronic disease that might interfere with study participation,
* BMI above 40 kg/m2,
* consumption of \>12 alcoholic drinks weekly,
* unwillingness to stop current supplement intake or use of calcium/ magnesium antacids.
"Computer-Guided vs Freehand Zygomatic Implant Placement

This randomized trial compares computer-guided versus free-hand zygomatic implant placement in patients with atrophic maxillae or maxillary defects. Participants receive either 3D-navigated implants (using stereolithographic guides) or conventional free-hand placement. Primary outcomes measure accuracy through apical angular deviation (°), apical/coronal linear deviations (mm) relative to MSP/FHP/CP planes (CT-based), while secondary outcomes assess implant stability (ISQ) and complications (sinusitis/infection) over 6 months. The study evaluates whether guided surgery improves precision in complex maxillary rehabilitation.

"This study was retrospectively registered due to initial lack of awareness of prospective registration requirements. All procedures followed ethical guidelines (Approval #880/62), and results are reported transparently."

Study Design

A single-center, randomized controlled trial conducted at Al-Azhar University, comparing computer-guided versus free-hand zygomatic implant placement. Participants are allocated 1:1 to:

Group A (Free-hand): Implants placed using ZAGA classification with conventional surgical techniques.

Group B (Guided): Implants placed via 3D-printed bone-supported surgical templates (DICOM-based planning).

Interventions

Both Groups:

Pre-op: CT scans for zygomatic bone assessment.

Anesthesia: General anesthesia with local infiltration for hemostasis.

Surgical Protocol: Full-thickness flap, implant placement , two-stage healing.

Group B-Specific Steps:

Digital implant path planning (entrance/exit points).

Stereolithographic guide fabrication with metal sleeves.

Guide fixation with monocortical screws during surgery.

Rationale Zygomatic implants require high precision due to anatomical complexity. While free-hand placement depends on surgeon skill, computer guidance may reduce errors. This trial evaluates whether guided surgery improves accuracy (angular deviation) and reduces complications (sinusitis, infection).

Methodological Rigor Randomization: Block randomization via SPSS.

Blinding: Radiographic assessors blinded to group allocation.

Sample Size: 16 implants (8/group), powered to detect 3.73° mean angular deviation difference (α=0.05, β=0.10; based on Grecchi et al. 2022).

Ethical Compliance Approved by Al-Azhar University (Ref: 880/62).

Consent forms documented risks/benefits (e.g., sinus perforation, infection).

Eligibility Criteria:
Inclusion Criteria:

* Patients aged ≥40 years
* Atrophic maxillary ridge (Cawood \& Howell Class IV-VI)
* Maxillary defects due to trauma, tumor resection, or congenital conditions

Exclusion Criteria:

* Acute maxillary sinusitis
* Uncontrolled systemic diseases affecting osseointegration
* Pathological lesions in maxilla/zygoma
* Heavy smoking (\>20 cigarettes/day)