cyrilzakka/clinical-trials huggingface dataset:
Study of Avelle™ Negative Pressure Wound Therapy (NPWT) System

The main questions the study aims to answer are:

* How much do wounds improve when using the Avelle™ Negative Pressure Wound Therapy System for a maximum of 14 days?
* How safe is the Avelle™ Negative Pressure Wound Therapy System?

The goal of this observational study is to gather information about the the Avelle™ Negative Pressure Wound Therapy System in people that have a wound that leaks fluid and is 14 days old or less. The Avelle™ Negative Pressure Wound Therapy (NPWT) System combines a sterile dressing comprising gelling fibre technology to absorb wound exudate with negative pressure applied to the wound via a vacuum pump. The Avelle™ NPWT System consists of a disposable single patient use battery powered pump, absorbent wound dressing, and fixation strips.

Participants will:

* be asked questions about their medical history and medications
* asked to allow the wound and surrounding skin to be examined
* be asked to use the Avelle™ Negative Pressure Wound Therapy System for a maximum of 14 days
* be asked to review any issues or concerns with the Avelle™ Negative Pressure Wound Therapy System

Eligibility Criteria:
Inclusion Criteria:

1. Subject is ≥ 18 years of age.
2. Subject is willing and able to take part in the study and provide written informed consent.
3. Subject has one target wound which is ≤ 14 days old
4. Subject has target wound that is intended to heal by primary intention
5. Subject has a target wound which is ≤ 25% of the dressing area as per the Instructions For Use
6. Target wound has low to moderate exudate
7. Wound is suitable for treatment with Avelle™ NPWT
8. Subject is deemed capable and willing to comply with the protocol and product instructions.

Exclusion Criteria:

1. Subject has an existing health condition that would compromise their participation and follow-up in this study such as the ability to understand and follow instructions
2. Subject has been treated with another NPWT system during the past 14 days
3. Subject, in the opinion of the Investigator, is not clinically suitable for inclusion
4. Subject is contraindicated for the Avelle™ NPWT System
ASSIST: A Surveillance Study of Illicit Substance Toxicity

There is a drug-related death crisis in Scotland. This study aims to collaborate with Public Health Scotland in order to assess the feasibility of introducing a surveillance system to the Emergency Department to highlight illicit drug-related attendances. This will utilise both clinical data and toxiclogical analysis of anonymised samples. The data will inform of prevalence, trend data and utcome of ED patients attending with acute illict drug toxicity.

The purpose of this research is to establish the introduction of a robust toxicology surveillance system in the Emergency Department (ED) in order to inform public health interests. The study will explore the feasibility of reporting characteristics and causative agents of patients attending hospital as an emergency due illicit substance use. The term illicit substance used during this study encompasses any substance which is not prescribed to the individual and is a controlled drug as per the Misuse of Drugs act 1971 and Misuse of Drugs Regulations 2001.

The study will look at standard care clinical data from all individuals attending the Emergency Department due to acute illicit drug toxicity. Surplus blood samples will be anonymised and analysed for toxicological profiling.

The study will allow identification of emerging drug trends and will be shared contemporaneously with Public Health Scotland and inform the Scottish Government of current incidences to inform public health measures to tackle the drugs death crisis.

Eligibility Criteria:
Inclusion Criteria:

* Age \>16
* Patient attending QEUH ED directly relating to acute illicit drug use
* Patients with reported acute illicit drug use toxicity who are unwell before they are seen in the Emergency Department but appear well in the ED should also be included

Exclusion Criteria:

* Condition more likely due to cause other than acute illicit drug use
* Condition due to withdrawal of drugs / alcohol
* Condition primarily related to alcohol use and no evidence of acute illicit drug use
* Attendance is due to complication of previous drug use - i.e., BBV / infected injection site (without acute drug toxicity)
An Observational Study to Evaluate the Incidence of MACCE According to Time Interval of Taking Medication in Patients With Acute Coronary Syndrome or Cerebral Infarction Who Received DAPT for the Secondary Prevention and Esomezol Cap for the Prevention of Gastrointestinal Bleeding

This study is to evaluate the incidence rate of Major Adverse CardioCerebrovascular Events(MACCE) in Patients with Acute Coronary Syndrome or Cerebral Infarction Who Received DAPT for the secondary prevention and Esomezol Cap for the prevention of gastrointestinal bleeding.

This study was a multi-center, prospective, non-interventional, observational study of administering Esomezol Cap for the purpose of preventing gastrointestinal bleeding.

Data was collected from patients receiving routine treatment at hospitals in South Korea. Each patient visited the institution according to the protocol that designed the follow-up visits for six months to examine the safety of Esomezol Cap.

This study approved by the institutions' IRBs and was conducted in compliance with clinical research ethics regulations.

Eligibility Criteria:
Inclusion Criteria:

1. Age≥19
2. Among patients who visited the hospital due to the onset or recurrence of acute coronary syndrome or cerebral infarction within 1 month prior to registration, patients who are expected to receive DAPT(Clopidogrel + Aspirin) for at least 6 months, in combination with Esomezol Cap for the purpose of preventing gastrointestinal bleeding Patients receiving or planning to receive treatment
3. Subject who can written informed consent voluntarily

Exclusion Criteria:

1) Patients for whom use of Esomezol Cap is prohibited
Comparing Two Different Approaches in Robotic-Assisted Renal Surgery

The purpose of this study is to determine if the novel TR approach is superior to the standard RP approach. The anticipated study outcome is a time saving of at least 30% from first skin incision to detection of the renal artery compared to the conventional RP approach, and also a better workspace perception by the operating surgeon.

The trans abdominal approach (TA) for total and partial nephrectomy (PN) has been widely adopted due to the easy trocar placement and the good working space. The retroperitoneal approach (RP) has gained popularity because the renal artery is often found fast and the operation remains in an anatomically separated space, making it preferable, especially for patients who underwent abdominal surgery in the past. However, both approaches face difficulties. Trocar placement for RP can be challenging, and the working space often is limited, while TA is impaired in cases of dorsal tumors and dissection of the renal artery can be challenging due to the anatomic localization dorsally to the renal vein. Up until now, no direct systematically and prospective comparison of these two approaches was performed.

The overall objective of this trial is to assess if the novel TR approach is superior to the conventional RP approach in performing robotic assisted (partial) nephrectomy. To date, no systematic, prospective, randomised study has been conducted on this topic and described in the literature.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Patient with a renal tumor or non-functionally kidney that is a candidate for robotic assisted surgery (RAS) nephrectomy or partial nephrectomy (PN)
* Informed Consent as documented by signature (Appendix Informed Consent Form)

Exclusion Criteria:

* Renal vein tumor thrombus
* Pregnancy or suspected pregnancy
Impact of Passive Heat on Metabolic, Inflammatory and Vascular Health in Persons With Spinal Cord Injury

SCI results in higher incidence of heart disease and diabetes and heart disease is the most common cause of death. Chronic inflammation, deleterious changes in vascular structure and impaired glucose metabolism are risk factors that contribute to both heart disease and diabetes. While exercise can help reduce these risk factors, paralysis and impaired accessibility often precludes exercise in persons with SCI. New research in able-bodied persons demonstrates passive heating decreases inflammation and improves vascular function. Similar studies in persons with SCI suggest they may also have the same health benefits however these studies only investigated the impact of short term (one episode) passive heating (as opposed to repeated bouts). Repeated bouts of heat exposure will likely be required to impact chronic inflammation, but this has never been tested in persons with SCI. This study will test the impact of repeated bouts (3x/week) of passive heat stress over a longer term (8 weeks) on inflammation, metabolism and vascular function.


Eligibility Criteria:
Inclusion Criteria:

* Stable SCI over 1 year of duration

Exclusion Criteria:

* Persons who smoke cigarettes
* Daily administration of anti-inflammatory medications
* Daily administration of vasoactive medications
* Pressure ulcer stage 3 or 4
* History of heat related illness
Long-term Beta-blocker Therapy After Acute Myocardial Infarction

The aim of the study is to determine whether discontinuation of β-blocker after at least 1 year of β-blocker therapy is noninferior to continuation of β-blocker in patients without heart failure (HF) or left ventricular systolic dysfunction after acute myocardial infarction (AMI).

Prospective, open-label, randomized, multicenter, noninferiority trial to determine whether discontinuation of β-blocker after at least 1 year of β-blocker therapy is noninferior to continuation of β-blocker in patients without HF or left ventricular systolic dysfunction after AMI.

β-blockers have anti-ischemic, anti-arrhythmic, and anti-adrenergic properties. In order to reduce cardiovascular mortality and morbidity, current major guidelines recommend that oral treatment of β-blockers should be continued during and after hospitalization in patients with acute myocardial infarction (AMI) and without contraindications to β-blocker use.

A clinically important but difficult decision on β-blocker therapy after AMI is to determine the duration of β-blocker therapy after discharge in patients without heart failure (HF) or left ventricular systolic dysfunction. Previous studies for long-term β-blocker therapy after AMI were inadequate to derive definite conclusion because of small sample size and potential selection bias.

Therefore, the SMART-DECISION trial will investigate whether discontinuation of β-blocker after at least 1 year of β-blocker therapy is noninferior to continuation of β-blocker in patients without HF or left ventricular systolic dysfunction after AMI.

Eligibility Criteria:
Inclusion Criteria:

* Subject must be at least 19 years of age.
* Subject who have been continuing β-blocker therapy for at least 1 year after acute myocardial infarction regardless of the time of diagnosis
* Subject is able to verbally confirm understandings of risks and benefits of this trial, and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.

Exclusion Criteria:

* Subject whose left ventricle ejection fraction was less than 40% from echocardiography performed after acute myocardial infarction or who have never received echocardiography.
* Treatment history of heart failure
* Contraindication to β-blocker therapy (history of symptomatic bronchial asthma or chronic obstructive pulmonary disease, 2nd or 3rd degree AV block, cardiac pacemaker implantation, or other cases where β-blocker cannot be used under the judgment of the clinician)
* Non-cardiac co-morbid conditions are present with life expectancy \<1 year or that may result in protocol non-compliance (per site investigator's medical judgment).
* History of atrial fibrillation
* Pregnancy or breast feeding
Effect of Onchocerciasis Elimination Measures on the Incidence of Epilepsy in Maridi, South Sudan

For the first time using a prospective design, a study confirms the results of previous retrospective studies, which found that strengthening onchocerciasis elimination efforts decreases the incidence of epilepsy, including nodding syndrome. Therefore, this study confirms the solid epidemiological link between onchocerciasis and epilepsy.

This study also shows that a community-based "Slash and Clear" vector control method can effectively decrease blackfly biting rates and potentially decrease onchocerciasis transmission.

Moreover, this study shows that epilepsy is a major cause of death in onchocerciasis endemic areas with high ongoing transmission.

Background High onchocerciasis transmission predisposes communities in endemic areas to a high epilepsy burden. The 4·4% (95%CI:4·1-4·7%) epilepsy prevalence documented in 2018 in Maridi, South Sudan, motivated the strengthening of onchocerciasis elimination measures. We evaluated the effect of these interventions on the incidence of epilepsy, including nodding syndrome (NS).

Methods Annual community-directed treatment with ivermectin (CDTi) was implemented in 2019, temporarily interrupted in 2020 and reimplemented biannually in 2021. Additionally, a community-based "Slash and Clear" vector control method was initiated in 2019 at the Maridi dam. A two-stage house-to-house survey was conducted before (2018) and after (2022) implementing the interventions, consisting of initial screening by community workers to detect suspected cases of epilepsy, followed by confirmation of the diagnosis by a trained clinician.

Finding Overall, 17,652 and 14,402 individuals participated in the pre- and post-intervention surveys, respectively. The epilepsy incidence decreased from 313·0 (95% confidence intervals (CI):273·7-357·7) to 34·7 (95%CI:17·6-66·1) per 100,000 person-years. Similarly, the incidence of NS decreased from 120·4 (95%CI:96·7-149·6) to 10·4 (95%CI:2·7-33·2) per 100,000 person-years. Despite biannual CDTi, only 56·6% of the population took ivermectin in 2021. Mortality of persons with epilepsy accounted for 17·1% (95%CI:14·0-20·7%) of the overall number of deaths in the population.

Interpretation In onchocerciasis-endemic areas with high prevalence of epilepsy, strengthening onchocerciasis elimination interventions can decrease the incidence of epilepsy, including NS. Additional efforts are needed in Maridi, where epilepsy is a major cause of mortality, to increase CDTi coverage and sustain blackfly control.

Eligibility Criteria:
Inclusion Criteria:

* entire population of selected villages in Maridi County

Exclusion Criteria:

* No
High-Dose (HD) Methotrexate (MTX) Induction Chemotherapy Followed by Alternative HD MTX-based and HD Cytarabine-based Combination Consolidation Chemotherapy for Newly Diagnosed Primary CNS Lymphoma; CISL 10-01 Study

The purpose of this study is to evaluate the complete response (CR) rate after HD-MTX induction chemotherapy followed by alternative HD MTX-based and HD Cytarabine-based combination consolidation chemotherapy


Eligibility Criteria:
Inclusion criteria

1. Histologically confirmed Primary Central Nervous System (CNS) lymphoma
2. Previously untreated. Patients treated with steroid alone are eligible.
3. Performance status: ECOG 0-3.
4. Age; 20-70
5. Adequate renal function: Estimated glomerular filtration rate (GFR) or estimated creatinine clearance (CrCl) ≥ 50 mL/min
6. Adequate liver functions: Transaminase (AST/ALT) \< 3 X upper normal value \& Bilirubin \< 2 X upper normal value
7. Adequate hematological function: hemoglobin ≥ 9 g/dL absolute neutrophil count (ANC) ≥ 1,500/μL and platelet count ≥ 75,000/μL
8. At least one cerebral mass lesion on magnetic resonance imaging (MRI) without involvement beyond the central nervous system (CNS)
9. Life expectancy \> 6 months
10. A negative serum or urine pregnancy test prior to treatment must be available both for pre menopausal women and for women who are \< 1 years after the onset of menopause.
11. Informed consent

Exclusion criteria

1. Other subtypes NHL than Primary Central Nervous System (CNS) lymphoma
2. Systemic involvement of Primary CNS lymphoma except leptomeningeal involvement
3. Intraocular lymphoma
4. HIV (+)
5. Any other malignancies within the past 5 years except curatively treated non-melanoma skin cancer or in situ carcinoma of cervix uteri
6. Pregnant or lactating women, women of childbearing potential not employing adequate contraception
7. Other serious illness or medical conditions

   * Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry
   * History of significant neurological or psychiatric disorders
   * Active uncontrolled infection (viral, bacterial or fungal infection)
8. Patients who have HBV (+) are eligible. However, primary prophylaxis using antiviral agents (i.e. lamivudine) is recommended for HBV carrier to prevent HBV reactivation during whole treatment period.
9. Concomitant administration of any other experimental drug under investigation, or concomitant chemotherapy, hormonal therapy, or immunotherapy.
Determinants of Pterygium Occurrence and Recurrence in a Rural African Population

The aim of the study is to find out why pterygium occurs and recurs in a rural African population. Participants will be interviewed on personal and lifestyle information, family history of pterygium, environmental exposure and history of previous eye inflammation. They will undergo eye examination and photography. Those with pterygium will be operated on to remove pterygium and followed up to detect any recurrence and complications of surgery. The excised pterygium will be examined pathologically and genetically; participant's blood will also be examined genetically. Data will be analyzed for statistically significant differences in findings between pterygium and pterygium free participants.

The study hypothesis is that multiple factors are responsible for the occurrence and recurrence of pterygium in a rural african population.


Eligibility Criteria:
Inclusion Criteria:

1. Pterygium at least 1.5mm in extent
2. Both male and female
3. Age range 21-65 years
4. Consenting to participate in study
5. Unilateral and bilateral pterygium
6. All grades of pterygium

Exclusion Criteria:

1. Previous cataract, corneoscleral and glaucoma surgery or corneoscleral trauma and corneolimbal scars
2. Pseudopterygium or signs of malignancy on pterygium
3. Recurrent pterygium
4. Sufferers of collagen vascular disease, scleritis or diabetes -
SMaRT Mom - Smartphone Management and Responsive Time for Breastfeeding Mothers

In the last decade, infants are born into a social environment in which the smartphone has become an essential part of our lives. Smartphone use draws the mother's attention during mother-infant interactions and thus may affect the infant development as well as maternal self-efficacy. However, the effects of smartphone use reduction among breastfeeding mothers during their interactions with their infants have not been studied yet. In the present study, we propose to evaluate a "SMaRT Mom" intervention that we have developed, to manage and reduce smartphone use during breastfeeding. The purpose of the study is to evaluate the effects of the SMaRT Mom intervention on breastfeeding mothers' biobehavioral mechanisms, self-efficacy and the socioemotional characteristics of their infants. This will extend our knowledge of the peculiarities of early mother-infant interactions in the digital era, when smartphones play a critical role.


Eligibility Criteria:
Inclusion Criteria:

* 3-6 months old infant
* Smartphone Addiction Scale' cut-off (31 and above)

Exclusion Criteria:

* No neurological disorders
* No heart disease
* No anxiety and depression
* No use of psychiatric drugs
An mHealth Trial to Promote the Use of Postpartum Contraception

Multiple encounters of pregnant women with the health care system during the late antenatal and immediate postpartum period provide a gateway for postpartum family planning counselling. Counselling on family planning services during this time is considered effective and cost-efficient for promoting healthy timing and spacing of pregnancies. This research aims to test the effectiveness of mobile phone-based interventions in promoting use of postpartum contraception.

The study will be a three-arm, 10-month, multicentre, parallel-group, randomized controlled trial which will be conducted at 15 Suraj social franchise(SF) health facilities in Punjab province of Pakistan. Pregnant women aged 15-44 years who are in their first or second trimester and have a mobile phone for their own use will be eligible to participate in this study. The participants will be randomly allocated to one of three study arms: a) voice and text messages; b) interactive telephone-based counselling; or c) control arm (no additional phone-based support). The intervention counselling module will be developed based on the Integrated Behaviour Model which was recently adapted, and tested for the family planning context in Pakistan. It will broadly cover birth-preparedness, birth spacing and contraception, and postnatal care. The phone-based intervention aims to improve women's ability to use contraception by providing them with information about a range of methods, access to family planning methods through outlets such as Suraj SF providers, connecting them with MSS field health educators to help them reach the centres, motivation by re-enforcing the benefits of contraceptive use on women's quality of life, and dispelling myths and misconceptions about modern contraceptive methods. Risk differences will be used as the measure of effect of the intervention on the outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Married
* Pregnant women with gestational age up to 20 weeks
* 15-44 years old throughout duration of study
* Literate
* Access to a cellphone
* Living in the study's catchment area

Exclusion Criteria:

* Not up to 20 weeks pregnant
* Not between 15-44 years old for the study duration
* Illiterate
* Does not have regular access to a cellphone
* Not residing within the catchment area
* Does not provide consent to participate