cyrilzakka/clinical-trials huggingface dataset:
Post-Marketing Surveillance Study of Adalimumab in Pediatric Chronic Severe Plaque Psoriasis Patients in Korea

The objective of this study is to evaluate the real world safety and effectiveness of adalimumab (Humira) for the treatment of Korean patients with pediatric chronic severe plaque psoriasis under a routine treatment practice.


Eligibility Criteria:
Inclusion Criteria:

* Children and adolescents who are diagnosed with pediatric chronic severe plaque psoriasis.
* Prior to participating in the study, adalimumab treatment was determined according to clinical judgement of the physician.
* Participants (or legal representative) who voluntarily agreed to participate in this study and signed informed consent.

Exclusion Criteria:

* Participants with contraindication to adalimumab as listed in the approved Korean label.
* Participants with prior treatment with adalimumab.
Pediatric Research on Improving Speed, Memory and Attention

Introduction:

The aim of this study is to investigate the efficacy of neurofeedback (NFB) to improve attention, memory and processing speed in children treated for a Brain Tumour (BT). In the Netherlands every year approximately 100 children are diagnosed with a BT. Nowadays over 65% of these children have a 5-year survival. Treatment for a BT consists of neurosurgery and / or local or craniospinal radiation and / or adjuvant chemotherapy. Neurotoxicity caused by radiotherapy and / or chemotherapy (especially methotrexate) is a major cause of neurocognitive decline in Childhood Brain Tumour Survivors (CBTS).

Approach:

Studies have shown that NFB has the capacity to improve the brain systems mediating selective attention and response inhibition in children with Attention Deficit/Hyperactive Disorder (ADHD). The effectiveness is reported as comparable to methylphenidate (Ritalin) without side effects of medication. CBTS exhibit symptoms comparable to those of children with ADHD and positive response to methylphenidate has been found in CBTS. However, NFB has not been used as an intervention in CBTS yet. The effectiveness of NFB in children treated for a BT will be investigated in a randomized controlled trial. The intervention group of 30 patients will receive approximately 30 sessions of NFB; the control group will receive 30 session of placebo neurofeedback. Neuropsychological tests will be used to evaluate pre- and post-NFB intervention as well as at a 6-month follow-up.

Relevance:

If NFB proofs to be effective for CBTS this will be a great improvement for their (neuro-) psychological functioning and quality of life, without the disadvantage of the side effects of medication. The implementation of this intervention might increase cognitive and social functioning and thus facilitate integration of these children in society during childhood and school carrier as well as in adult life.


Eligibility Criteria:
Inclusion Criteria:

* Being treated for a brain tumour before the age of 16 years
* Age between 8-18 years at time of enrolment
* Off treatment at least two years
* Problems on attention, or memory or speed processing as reported by parents in screening test
* Being able to speak and understand the Dutch language

Exclusion Criteria:

* Premorbid AD/HD
* Mental or physical condition that make the neuropsychological assessment impossible to finish
Indirect Calorimetry Guided Energy Provision in Critically Ill Patients With Obesity

The DIRECT trial is a prospective, multi-centre, two arm parallel feasibility pilot randomised controlled trial. The primary aim is to determine the feasibility of using repeat indirect calorimetry measurements to direct energy delivery in critically ill patients with obesity.

The trial will recruit 60 mechanically ventilated patients from 4-6 ICUs in Australia and New Zealand.

Indirect calorimetry is the current reference standard for measuring energy expenditure during critical illness, allowing for personalisation of energy delivery. Use of indirect calorimetry may be important in mitigating under- and overfeeding and associated adverse outcomes. This may be particularly important in patients with obesity, where energy expenditure is difficult to estimate, and limited data is available on the optimal nutritional management of this subgroup.

Although access to indirect calorimetry is gradually improving, it remains an underutilised tool and skills required to complete and interpret measurements are limited which may hinder use and integration into practice. There is a resulting knowledge gap on the impact of indirect calorimetry on outcomes in comparison to standard care predictive equations.

A definitive and pragmatic trial is needed to assess the impact of guiding energy delivery with indirect calorimetry on patient outcomes. Importantly, confirming the feasibility of using indirect calorimetry to guide energy delivery is needed to define optimal measurement protocols prior to completion of a larger trial.

The primary aim of the DIRECT trial is to determine the feasibility of using repeat indirect calorimetry measurements to direct energy delivery in critically ill patients with obesity. The secondary aim is to inform a larger trial by collecting process, nutrition, functional, clinical and safety outcomes.

The investigators will consider the main trial feasible to conduct if 2 of the following 3 feasibility criteria are achieved: (a) recruitment rate is ≥ 1 patient per calendar month; (b) between group separation of ≥20% in energy adequacy during ICU admission is achieved in relation to measured energy expenditure and; (c) the number of indirect calorimetry measurements completed/planned ≥60% during ICU admission.

Eligibility Criteria:
Inclusion Criteria:

* Adult (≥ 18 years) patients
* Body mass index ≥30 kg/m2
* Between day 3 and 6 of index ICU admission
* Receiving invasive mechanical ventilation
* Receiving enteral or parenteral nutrition

Exclusion Criteria:

* Receiving extracorporeal membrane oxygenation support
* Major burns (≥20% total body surface area)
* Unable to perform indirect calorimetry within 24 hours of randomisation
* Known pregnancy
* Death is imminent
* Treating clinician believes the study is not in the best interest of the patient
Hydroxychloroquine as Prophylaxis for COVID-19 in Healthcare Workers (HCQPreP)

This a double-blind, randomized, placebo-controlled clinical trial to determine if primary prophylaxis with hydroxychloroquine in healthcare workers reduces symptomatic COVID-19 infection. Healthcare workers will be randomized at a 1:1 allocation between intervention and placebo arms and followed for 12 weeks. This study will enroll up to 1,700 participates in Lafayette, Louisiana. The primary outcome will number of symptomatic COVID-19 infections. Secondary endpoints included number of days healthcare workers are absent from work and rate of severe infection.

The study is a double blind placebo controlled at two hospitals in Lafayette, Louisiana aiming to enroll 1700 participants with a 1:1 randomization. The HCQ dose in 400mg twice on day 1, then 200mg twice weekly. The primary outcome variable is development of symptomatic COVID-19 infection. The secondary objectives are number of days absent from work due to symptomatic COVID-19 infection and rate of severe disease due to COVID-19 (hypoxia in setting of \>50% lung involvement on chest imaging, respiratory failure, shock or end-organ damage). The study will enroll participants for four weeks with and plan to treat with hydroxychloroquine versus placebo for a total of 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years
2. Healthcare or Hospital Worker who has direct patient contact
3. Willing to participate in the research.
4. Able to understand and sign the informed consent form

Exclusion Criteria:

1. Age \< 18 years
2. History of ventricular arrhythmia or use of Class IA, IC and III anti-arrhythmics
3. Known prolonged QTc interval
4. History of retinal disease
5. Kidney failure with GFR \<10%
6. Chronic hepatic disease w/ Child-Pugh class B or C
7. Hypersensitivity to chloroquine or hydroxychloroquine
8. Currently taking chloroquine or hydroxychloroquine
9. Unwilling to participate
10. Unable to understand and/or sign the informed consent form.
Safety and Efficacy of Triple Combination Therapy in Patients With Primary Open-Angle Glaucoma or Ocular Hypertension

This study will evaluate the safety and efficacy of Triple Combination Therapy compared with Fixed Combination brimonidine tartrate/timolol ophthalmic solution in patients with primary open-angle glaucoma or ocular hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Ocular hypertension or primary open-angle glaucoma in each eye
* Requires treatment with IOP-lowering medication in both eyes

Exclusion Criteria:

* Required chronic use of ocular medications during the study other than study medication
* Use of any corticosteroids within 30 days
* History of any prior eye surgery, except for uncomplicated eye surgery performed more than 6 months before the Screening visit
* Anticipated wearing of contact lenses during the study
A Parallel Group Phase II Study of KCT-0809 in Patients With Dry Eye Syndromes

The purpose of this study is to evaluate the efficacy and safety of KCT-0809 compared to placebo in patients with dry eye syndromes.


Eligibility Criteria:
Inclusion Criteria:

* Corneal and conjunctival damage
* Insufficiency of lacrimal secretion
* Ocular symptom

Exclusion Criteria:

* Severe ophthalmic disorder
* Punctual plugs or surgery for occlusion of the lacrimal puncta
Hope Theory as Ability Determinant to Permanently Change the Adapted Physical Activity (APA) in Type 2 Diabetic Patients

The control of diabetes is related both to food, treatment but also to physical activity. Despite these recommendations and these positive findings, patients are always sedentary because of brakes in the practice of a regular physical activity.

It is therefore interesting to consider the representations of patients and particularly on the way of establishment in order to reach a goal. The Hope Theory highlights the hope as the sum of the will and means that an individual has to achieve its goals. Will be discussed in this study to identify a relationship between the level of hope for patients and their ability to permanently change their behavior in regular physical activity as part of the goals set during the week of therapeutic education patient.


Eligibility Criteria:
Inclusion Criteria:

* Major Topic
* Type 2 Diabetic Topic
* Inactive Topic
* Subject of CHU ANGERS hospitalized for a week Diab'Equilibre, Diabetology Service
* Subject participating in the service of the APA program
* Subject who understands and reads French
* Subject has given its consent to participate signed the protocol

Exclusion Criteria:

* Removing the participation of consent;
* Severe heart failure
* Severe respiratory failure
* Bone metastases
Efficacy and Safety Study of Budesonide to Treat Oral Chronic Graft vs Host Disease (cGvHD)

The purpose of the study is to compare the efficacy and tolerability of budesonide 3 mg effervescent tablet (9 mg/day) compared to placebo for the treatment of patients with resistant oral cGvHD.


Eligibility Criteria:
Inclusion Criteria:

* Karnofsky \>= 70
* Oral chronic GvHD after allogeneic haematopoietic stem cell transplantation
* Oral cGvHD of erosive and/or ulcerative type
* NIH scale \>= 3
* Resistant oral cGvHD with no oral response to conventional primary treatment

Exclusion Criteria:

* Uncertain diagnosis of resistant oral cGvHD
* Symptomatic oral cGvHD of hyperkeratotic type solely
* Current active oral bacterial, viral, or fungal infection
* Unwilling to forego concurrent treatment for mucosal lesions and/or related oral pain
* Requiring addition of new systemic therapy including steroids, or radiation therapy
* Local intestinal infection
* Abnormal hepatic function or liver cirrhosis
* If careful medical monitoring is not ensured: tuberculosis, cardiovascular disease, diabetes mellitus, osteoporosis, active peptic ulcer disease, glaucoma, cataract, infection
* Second line treatment of oral cGvHD with topical steroids
Evaluating the Healthy Families PrEP Program for Women At Risk for HIV

Study investigators developed and piloted a counselling intervention, Healthy Families-PrEP, that supports women to use HIV prevention strategies while trying for and during pregnancy. They will now adapt the intervention to community clinics and postpartum women and test the intervention. The goal is to reduce HIV incidence among women and children.

Women in Uganda who are planning for pregnancy, pregnant, or postpartum and have a partner living with HIV are vulnerable to acquiring HIV.

Adapting this intervention to community clinics and testing effectiveness aligns with global and Ugandan Ministry of Health goals to reduce HIV incidence among women of reproductive age and eliminate perinatal transmission. Additionally, costing analyses will be conducted to determine the cost of implementing HF-PrEP from both payer and societal perspectives. This work will inform future intervention implementation.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years and ≤45 years
* Willing and able to participate in the informed consent process
* HIV-uninfected by self-report, but have indications for HIV prevention strategies, such as having a partner living with HIV or who they think may be living with HIV
* Reporting pregnancy in the past 2 years, and/or desire to have a child in the next year, and/or have a partner who desires to a child in the next year
* Fluent in English or local language
* Living within 60km of a healthcare center included in the trial
* HIV Negative (onsite rapid testing)

Exclusion Criteria:

* Not reporting pregnancy in the past 2 years
* Does not report personal or partner desire to have a child in the next year
* Not willing to provide informed consent
* Not able to communicate in English or local language
* Does not report pregnancy in the past 2 years and/or does not report personal or partner desire to have a child in the next year
* Not able to communicate in English or local language
* Living beyond 60km of the trial healthcare center
* HIV-positive (onsite rapid testing)
Attachment Predicts Post Cesarean Pain

The Adult Attachment Style (AAS) is a questionnaire designed to measure how an adult generally feels in their close personal relationships. The questionnaire has two main axes of measurements - avoidance and anxiety, that gives rise to four different categories of attachment styles. Women's attachment styles have been shown to be correlated to pain during labour, but not after. No study has analyzed whether attachment styles are correlated to the pain after cesarean section. This study will assess correlation between the AAS score, and pain after elective cesarean section. Additionally, this study aims to clarify the correlation between attachment scale and overall quality of recovery after cesarean section as defined by a recently validated tool, the ObsQoR10.

Overall recovery after cesarean section is difficult to measure and must consider several factors that may influence recovery. The ObsQoR10 is a recently validated tool that provides an overall picture of post cesarean recovery using pain, functional milestones, and emotional needs1. One of the factors that may influence recovery post operatively is a person's Adult Attachment Style (AAS).

AAS refers to how a person "generally feels in close relationships in their lives" and is prevalent in literature in the context of chronic pain. AAS has been shown to be correlated to patients' psychological stress2, self reported pain intensity and even the prevalence of chronic pain conditions like fibromyalgia3. In a cohort of patients with chronic pain, securely attached individuals were less likely to report disability due to pain, depressive symptoms and perceived negative spouse responses in comparison to securely attached individuals4. Another cohort showed that patients were characterized as fearful avoidant were more likely to catastrophize their pain and exhibit activity avoiding behaviours5.

Literature on AAS in the context of pain experienced by parturients is not as well characterized. Costas-Martins et al showed that insecurely attached women experience more pain during labour6. Costas-Martins et al include in their cohort a number of cesarean patients but do not consider them separately. To date there has not been a study investigating whether the AAS of parturients undergoing cesarean section is correlated to their perceived pain.2

While pain is an important clinical outcome, overall recovery as measured by the ObsQoR10 may present a more complete clinical picture of the predictive power of a person's AAS. Our study aims to characterize whether parturients' AAS is correlated with their overall recovery post cesarean section as well as pain.

Eligibility Criteria:
Inclusion Criteria:

i. English Speaking ii. Elective Cesarean Sections iii. ASA 3 or lower iv. Singleton Pregnancy v. Between 37-40 weeks gestation

Exclusion Criteria:

i. Patient Refusal ii. History of chronic pain condition, currently on medication iii. Diagnosed General Anxiety Disorder iv. Diagnosed substance use disorder
Efficacy of Oral Colchicine in Prevention of Proliferative Vitreoretinopathy in Rhegmatogenous Retinal Detachment

This clinical trial will test the efficacy and safety of oral colchicine in prevention of proliferative vitreoretinopathy (PVR) in cases of rhegmatogenous retinal detachment


Eligibility Criteria:
Inclusion Criteria:

* Rhegmatogenous retinal detachment

Exclusion Criteria:

* PVR grade C
* Duration of retinal detachment ≥ one month
* History of cataract surgery
* History of RD surgery
The Effects of TMZ on Diabetic Nephropathy

With the improvement of people's living standard, the prevalence of Diabetes is increasing year by year. In present, 350 million people worldwide are suffering from diabetes, and by 2035, there will be as high as 600 million. Diabetes causes a variety of complications, including diabetic nephropathy, which is one of the most common complications of Diabetes. Diabetic nephropathy is a microvascular complication of diabetes. Microalbuminuria and glomerular filtration rate decrease are the main manifestation. Even more, it can progress to end-stage renal changes. Data showed that diabetic nephropathy accounts for about 40% of patients with end-stage renal disease receiving renal replacement therapy.

However, the treatment of diabetic nephropathy is still lacking. In the past 40 years, few drugs have been proven to ameliorate the progression of diabetic nephropathy. Even though, the renal function of a large number of diabetic nephropathy patients is gradually deteriorating. Therefore, it is urgent to find a therapeutic drug that acts on different targets.

Trimetazidine is a piperazine derivative. It is mainly used in the treatment of stable angina pectoris. Its safety has been well verified. In recent years, the role of trimetazidine in acute renal damage has been widely reported. A large number of studies have shown that trimetazidine can reduce the effect of contrast agent on renal function and reduce the incidence of contrast nephropathy. There fore, Trimetazidine is a promising drug for delaying the progression of diabetic nephropathy.

In the present study, there will be 2 groups last for 6 months. One is the control group, who will not receive trimetazidine and the another is the trimetazidine group, who will receive the treatment of trimetazidine, 35mg bid orally.

Eligibility Criteria:
Inclusion Criteria:

1. Older than 18 years of age;
2. Type 2 diabetes mellitus;
3. EGFR ≥30 to \<90 ml/min/1.73 m2;
4. Urinary albumin creatinine ratio (UACR) ≥ 30 mg/g;

Exclusion Criteria:

1. Women who are already pregnant or planning to become pregnant;
2. SBP \>180mmHg and/or DBP \>110mmHg;
3. UACR ≥ 3000 mg/g
4. Other non-diabetic renal diseases (such as polycystic kidney disease, lupus nephritis, ANCA-associated vasculitis, etc.);
5. NYHA cardiac function grade III or above
6. Those who have a history of cancer or are currently suffering from cancer;
7. Receiving immunosuppressant, cytotoxic or other immunosuppressive therapy in the first 6 months;
8. Patients with acute coronary syndrome, acute cardiac insufficiency or severe cerebrovascular disease in the previous month;
9. Patients refused to comply with the requirements of the study to complete the study;
10. In the investigator's judgment, the patient is unable to complete the study or comply with the requirements of the study (for management reasons or other reasons);
Long-term Evaluation of Sports Activity in Patients Whose Ankle Was Treated by Anatomical Reconstruction or Arthroscopic Repair Following Chronic Lateral Instability

The goal of this clinical trial is to compare at 5 years the sporting activity of patients whose ankle had been treated by reconstruction or repair following chronic lateral instability. The main question it aims to answer is:

What is the long-term sporting activity status of patients whose ankle had been treated by reconstruction or repair following chronic lateral instability ?

Participants will visit the clinic once every year during 5 years for clinical checkup.


Eligibility Criteria:
Inclusion Criteria:

* Patient, male or female, aged ≥ 18 years
* Patient with chronic ankle instability defined by:
* A history of trauma including a severe ankle sprain.
* Clinical symptoms persisting for at least 3 months at the time of inclusion: pain, swelling, sensation of 'giving way', sensation of instability, recurrent sprains; Clinical tests (drawer test, varus provocation test) confirming grade III laxity; Imaging results (MRI) confirming clinically suspected ligament damage.
* Patient affiliated to or benefiting from a social security scheme
* French-speaking patient who has signed an informed consent form

Exclusion Criteria:

* Patient with deltoid ligament injury, severe fracture or open trauma
* Patient with insufficient ligament remnant and/or in too poor a condition to allow Broström-type repair.
* Patient with a symptomatic osteochondral lesion
* Patient with ankle hyperlaxity (Beighton score \> 3)
* Patient with early ankle arthropathy (Takakura arthritis classification ≥ stage 3)
* Patient with neuromuscular disorders, systemic inflammatory disorders or tumours.
* Patient requiring surgery on both ankles
* Patients with a bony deformity of the ankle or foot on the affected side;
* Patients with professional athlete status
* Patient already included in another study
* Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
A Quality Improvement Process to Support Delivery of Cardiovascular Care in Community Mental Health Organizations

This pilot study will examine whether an implementation strategy will improve delivery of evidence-based care for cardiovascular risk factors for people with serious mental illness.

In this pilot study, the investigators will work with health home programs and pilot test an adapted Comprehensive Unit Safety Program (CUSP) implementation strategy to improve mental health providers' delivery of evidence-based cardiovascular risk factor care for hypertension, dyslipidemia and diabetes for individuals with serious mental illness. The project will also characterize implementation processes, organizational and provider-level factors, and cardiovascular disease risk factor care and control.

Eligibility Criteria:
Inclusion Criteria:

Study population 1:

* Psychiatric rehabilitation program and health home team staff, including providers and leadership are those employed by the psychiatric rehabilitation program or health home program.
* English-speaking.

Study population 2:

* People with serious mental illness participating in psychiatric rehabilitation health home programs.
* English-speaking

Exclusion Criteria:

* None