cyrilzakka/clinical-trials huggingface dataset:
Transplantation of Autologous RPE Versus Translocation of Autologous RPE and Choroid in AMD

The purpose of this study is to evaluate two surgical interventions in patients with AMD.

The Submacular surgical trials have shown that submacular membrane extraction alone did not improve or preserve visual acuity in patients with AMD. Transplantation of autologous RPE and translocation of autologous RPE and choroid represent two promising therapeutic interventions in patients with AMD. This prospective, randomized clinical trial compares the two surgical treatments and additionally compares the clinical results (visual acuity, FLA) with OCT- and UHR-OCT data.

Eligibility Criteria:
Inclusion Criteria:

* AMD and submacular cnv
* non responders to laser treatment or pdt
* treatment: rpe transplantation or rpe + choroid translocation
* age over 50 years

Exclusion Criteria:

* other additional retinal diseases, like diabetic or hypertensive retinopathy and vascular diseases.
* optic atrophy
* unstable glaucoma
Comparison of Thiopental and Propofol as Anaesteticum During ECT

Electroconvulsive therapy is the most effective treatment in severe depression and the effect is related to the generalized seizure induced by the treatment. General anesthesia is used during the treatment. Since only a brief period of unconsciousness is required anesthetics with a rapid recovery profile are used.

Methohexital, a barbiturat, is internationally considered "the golden standard", bot other short-acting anesthetics are used. In Denmark the most frequent used anestheticum for ECT is Thiopental, a barbiturat, but also Propofol, a non-barbiturat, is used in many psychiatric departments.

Several studies have shown that Propofol reduce seizure duration in comparison with barbiturates. So far, no studies have demonstrated any clinical implications of the reduced seiziure duration. However, these studies have included rather few patiens, most have been retrospective, and in the only prospective study conducted, uni-lateral ECT was used.

The aim of this study is to compare the clinical effect of ECT in patients anesthesized with either Propofol or Thiopental. The hypothesis is that the shorter duration of seizures found with Propofol as anestheticum will increase the number of treatments needed to clinial respons. Furthermore we want to study differences in EEG-relate parameters previously shown to have prognostic value. Hospitalized patients with major depression, who is to be treated with ECT, are randomized to anesthizia with either Thiopental or Propofol. They are rated with Hamilton depression scale and BDI before treatment, after six treatments and when treatment is concluded. When treatment is ended the patients are furthermore rated with MMSE to evaluate their degree of cognitive impairment.


Eligibility Criteria:
Inclusion Criteria:

* Major depression, hospitalized

Exclusion Criteria:

* age under 18, allergi to anestheticum, out-clinic patients, ECT because of other diseases
The Impact of Bright Classroom on Myopia

This trial aims to test the effectiveness and practicality of study in the Bright Classrooms with skylight and artificial light renovation in reducing incident myopia in Chinese primary school children over three years, as compared to children studying in conventional classrooms.

The investigators now propose a cluster-randomized controlled trial of Bright Classrooms to provide a definitive answer as to their effect on the reduction of myopia incidence with the interventions of students studying in bright classroom from skylight and artificial light renovation. The bright classroom trial will be conducted in Jiangxi Province, South-east China via Nanchang University Affiliated Eye Hospital and the artificial light renovation study will be in Zhejiang Province via Eye Hospital, Wenzhou Medical University. Classroom design and build will be supported by leading firm in this space, Velux. If the principal can be proven that such innovative architectural modifications and classroom light renovation successfully prevent myopia, it will provide an evidence-based justification for a broad variety of low-cost retrofits, new build designs and light renovation appropriate for various Chinese settings. These might include larger windows, skylights, artificial lighting and appropriate seating arrangements. Once in place, such architectural and light interventions could benefit children over many years, without extensive and difficult-to-sustain programs of behaviour change. This proof-of-principle project could address a significant global eye health challenge and have significant and sustainable socio-economic impact for China and built environments elsewhere throughout the world.

Schools selected for the trial are: Yifen County: 2 schools, Lichuan County: 2 schools, Yiyang County: 2 schools, Fuliang County: 1 school and Shanggao County: 1 school.

Eligibility Criteria:
Inclusion Criteria:

* Willingness of parents to give consent
* Membership in randomly-selected classes at the selected schools.

Exclusion Criteria:

* Children without consent from their parents will be excluded.
* Children having myopia (myopic spherical equivalent refractive error of \<= -0.5D in one or both eyes) at baseline are excluded from the primary analysis, although they will be included in the secondary analyses, so there will be no need to exclude them from continuing to study with their classmates and use the assigned classroom.
Etanercept (Enbrel®) in Psoriasis - Pediatrics

This study will evaluate the safety and efficacy of etanercept (Enbrel®) in children with Psoriasis.

On enrollment, participants underwent randomization in a 1:1 ratio to receive placebo or etanercept during the initial double-blind period. Participants could enter an escape group and receive open-label etanercept until week 12 if, at or after week 4, their Psoriasis Area and Severity Index (PASI) score either increased by more than 50% over baseline and by a minimum of 4 points at one visit or increased by more than 25% and by a minimum of 4 points at each of two consecutive visits.

During the open-label treatment period, all patients (including those who entered the escape group) received open-label etanercept. Participants who did not achieve PASI 50 at week 24 or PASI 75 at week 36 could discontinue the study or add topical standard-of-care therapy (low-to-moderate-potency topical corticosteroids) and continue to receive open-label etanercept until week 48.

At week 36, participants with PASI 50 at week 24 or PASI 75 at week 36 were randomly assigned to placebo or etanercept for 12 weeks in the withdrawal period. Participants in whom PASI 75 was lost resumed open-label etanercept through week 48 in the re-treatment period.

Eligibility Criteria:
* Patients with plaque psoriasis
* Patient may not receive certain psoriasis medications during the study
Acute Neurological Complications and Neurodevelopmental Outcome in Children Undergoing Extracorporeal Membrane Oxygenation.

The purpose of this retrospective study is to describe the different types of acute neurologic complications in children who underwent extracorporeal membrane oxygenation (ECMO), and their risk factors. The research will also assess the child health at 1 year after withdrawal from ECMO and in 2020 in terms of neurological state and quality of life.

Neurological complications are relatively common (around 30%) in patients undergoing extra corporeal membrane oxygenation (ECMO). They can be hemorrhagic or ischemic and are partly due to the difficulty of balancing heparin therapy. Few pediatric studies have estimated the incidence and risk factors for these lesions. In addition, the developmental monitoring and quality of life of these children is not systematic or standardized, and their long-term outcome deserves to be better evaluated.

The purpose of this retrospective study is to describe the different types of acute neurologic complications in children who underwent veno-veinous or veno-arterial ECMO and their risk factors. The study is being conducted at Necker Enfants Malades hospital between 2014 and 2019. The research will also assess the child health at 1 year after withdrawal from ECMO and in 2020 in terms of neurological state and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Children from 0 to 18 years hospitalized in PICU (pediatric intensive care unit) and who underwent veno-venous or veno-arterial extra corporeal membrane oxygenation (ECMO) between 2014 and 2019.
* Adult patients not oppose to participation in research or holders of parental authority of minor patients not opposed to participation in the study.

Exclusion Criteria:

- Other type of assistance than an ECMO (Berlin heart).
Clinical Reminders in Test Reports to Improve Guideline Compliance

Although beta-blockers are known to prolong survival for patients with reduced left ventricular ejection fraction, their use in the community and the VA is suboptimal.

Background:

Although beta-blockers are known to prolong survival for patients with reduced left ventricular ejection fraction, their use in the community and the VA is suboptimal.

Objectives:

To determine if a reminder attached to the echocardiography report would increase the use of beta-blockers among patients with depressed left ventricular function.

Methods:

We are randomizing consecutive patients undergoing echocardiography at one of three VA echocardiography laboratories with reduced left ventricular ejection fraction (\<40%) and no echocardiographic contraindication to beta-blockers (e.g. aortic stenosis) to a reminder for use of beta-blockers or to no reminder. The reminder gives starting doses for two commonly used beta-blockers (carvedilol and metoprolol). Patients are excluded from the analysis if they leave the health care system or die within three months of randomization. The primary outcome is a prescription for a beta-blocker between three and nine months following echocardiography

Status:

The project is complete.

Eligibility Criteria:
Inclusion Criteria:

Those undergoing echocardiography at one of the participating laboratories with an ejection fraction \< 45%.

Exclusion Criteria:

aortic stenosis, mitral stenosis
Piloting an Online Integrated Behaviour Change and Physical Activity Program

There is a significant disparity in access to physical activity programs for people with mobility impairments, which greatly impacts mobility, function and long-term wellbeing. This study will test an online, group-based intervention consisting of exercise and behaviour activation strategies targeting these and other outcomes. Importantly, this programming will be applied to patient groups across several clinical programs at Parkwood Institute.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age and over
* Neurological condition (i.e., brain injury, stroke)
* Completed rehabilitation and living in the community
* Participants must have some upper limb function permitting arm movement against gravity
* Physician clearance to participate in the study.

Exclusion Criteria:

* Not cleared by a physician.
* Not able to move upper limbs against gravity.
* No internet access.
Combination of Autologous MSC and HSC Infusion in Patients With Decompensated Cirrhosis

Though the results of autologous CD34+ cell infusion and MSC in independent studies have shown promise, yet they are yet to reach the desired long term outcome. The possible postulation for this is possibly because when using autologous CD34+ cell infusion, the inflammatory milieu of the liver may not be conducive for sustained effects of the mobilized CD 34+ cells. MSC have immunomodulatory effect (ref) and may improve the liver environment making it more beneficial for the CD34+ cells to function and survive. In addition, MSC has ben shown to produce hepatocyte growth factor which is protective against liver injury and beneficial for liver regeneration (shown in above tables). However, it remains to be understood how MSCs promote liver stem stem cells to differentiate into hepatocytes or expand the residual hepatocyte population. MSC can also directly inhibit the activation of hepatic stellate cells, the main source of extracellular matrix via MSC derived IL 10 and TNF-αand may also induce hepatic stellate cell apoptosis. Current lacunae in cell based therapy is based on the poor consensus and understanding on the best type of cells to be used, the ideal number of cells, the most appropriate route of administration and the need for repeat dosing . The concept that combination of autologous hematopoietic and mesenchymal stem cells infusion may be more beneficial than infusing any one of them alone has been discussed in many scientific forums but there are no study till date to either see the safety as well as the efficacy of this proof of concept .

With this above background data, we propose a study design which will be a safety study for combination use of autologous CD34+ and MSC


Eligibility Criteria:
Inclusion Criteria:

* Age between 20-70 years
* Clinically diagnosed for hepatic cirrhosis having a Child Pugh score of B or MELD \>10 but below 20
* Not willing for immediate liver transplantation either due to lack of donor tissue or financial issues
* Platelet count of \> 80,000 and INR \<1.6
* Life expectancy of at least 3 months based on MELD score and Child Pugh Score
* Ability to give informed consent

Exclusion Criteria:

* Age less than 20 or more than 70 years
* Have liver tumors or history of any other cancer
* Pregnant or lactating women
* Patients with hepato-renal syndrome and acute kidney injury (Any creatinine \> 1.6 will be excluded)
* Evidence of ongoing sepsis - as per Surviving sepsis guideline
* Recent gastrointestinal bleeding or spontaneous bacterial peritonitis (within last one month)
* Any HIV positive patients
* Co-morbid conditions such as severe cardiac and/or pulmonary disease
* Inability to give informed consent
Comparative Study of Multi-endodiathermy Retinectomy Versus Relaxing Retinectomy for Retinal Re-detachment

Previous pilot study has demonstrated that the novel multi-endodiathermy retinectomy is feasible, effective and safe for inferior retinal redetachments in the silicone oil-filled eyes of adults over a 3-month observation.

Here, the investigators conduct this randomized and multicenter clinical trial to compare the efficacy and safety between multi-endodiathermy retinectomy and relaxing retinectomy.

The relaxing retinectomy is a useful surgery for retinal re-detachment in eyes with silicone oil filled. However, it has some obvious disadvantages such as the cut of the normal retina surrounding, leaving a large area of retinal deficiency and significant exposure of retinal pigment epithelium and choroid membranes.

We proposed a novel multi-endodiathermy retinectomy as a potential surgery. A pilot study has demonstrated that the novel multi-endodiathermy retinectomy is feasible, effective and safe for inferior retinal redetachments in the silicone oil-filled eyes of adults over a 3-month observation.

Here, the investigators conduct this randomized and multicenter clinical trial to compare the efficacy and safety between multi-endodiathermy retinectomy and relaxing retinectomy.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-60 years, male or female;
* The primary retinal detachment was caused by ocular trauma, and the vitreous body is filled with silicone oil now;
* The presence of inferior retinal re-detachment located among 3-9 o'clock.

Exclusion Criteria:

* Location of the re-detached retina is not mainly in the inferior of the eye;
* The fundus is unobservable because of severe corneal opacity;
* The contralateral eye is non-functional;
* Serious heart, lung, liver and kidney dysfunction.
Effects of Short Wave Diathermy Added on Dextrose Prolotherapy Injections in Osteoarthritis of the Knee

Goal: To show the effects of short wave diathermy added on prolotherapy injections in osteoarthritis of the knee on pain, physical functioning and quality of life.

Material and Methods: 63 patients with osteoarthritis of the knee with Kellgren-Lawrence (K-L) class 2 or 3 were included in the study. Patients were randomized to two grous, first being dextrose prolotherapy+ short wave diathermy(SWD), and second being dextrose prolotherapy with sham SWD. Patients were injected with dextrose prolotherapy solutions in the beginning, 3rd and 6th week of the study, for a total of 3 times, and took 20 minutes of SWD after injection(true or sham). Western Ontorio and McMaster Universities Osteoarthritis Index (WOMAC), Visual Analogous Scale for pain(VAS) and Short Form Health Survey (SF-36)were applied before, after(6th week) and at the 3rd month of treatment.


Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria were being between 45 and 75 years old, knee pain of 3 months or longer duration, and having OA of the knee compatible with Kellgren-Lawrance class 2 or 3

Exclusion Criteria:

* Patients using analgesics other than acetaminophen, having pregnancy, diabetes mellitus, infectious or inflammatory arthritis, hemophilia, knee prosthesis, history of knee injections in last 3 months or anticoagulant use, allergy to ingredients of the solutions, having cardiac pacemaker or other device, or metallic implants were exluded from the study.
Vetal Laban Intervention Trial Assessing Bowel Symptoms

A two month intervention trial assessing the effect of Vetal Laban containing L. acidophilus on enhancing functional bowel wellbeing among subjects with irritable bowel syndrome (IBS).


Eligibility Criteria:
Inclusion Criteria:

* Males and females aged 18 to 65 years
* Subjects fulfilling Rome III criteria for IBS
* Sufficient health and orientation for participating in the trial
* Obtained his/her informed consent after verbal and written information.
* Have a high probability for compliance with and completion of the study.
* Body Mass Index (BMI) between 19 and 35.

Exclusion Criteria:

* Diagnosed or suspected organic gastrointestinal disease (i.e. colitis, Crohn's disease, celiac disease, major bowel surgery, recurrent diverticulitis) or severely impaired general health including cancer and cancer therapy.
* Lactose intolerance
* Unwillingness to refrain from probiotic use during the trial
* Use of antibiotics within the 3 preceding months prior to recruitment
* Pregnant, planning pregnancy or lactating
* Expected major lifestyle changes related to nutrition, exercise, travelling etc.
* Participation in a clinical trial with an investigational product or drug within 3 months prior to screening.
* Substance abuse
* Subjects unable to read and understand the questionnaires
AA on Drug Abusers by Nursing Students

Drug abuse is a serious public health issue. Despite the serious consequences of drug abuse, there are around 2000 new cases reported by drug abusers each year. There is growing evidence of the use of auricular acupressure (AA), a traditional Chinese medicine (TCM) treatment modality, in reducing withdrawal symptoms among drug abusers. This study aims to investigate the feasibility and effectiveness of training nursing students to deliver brief education on AA on drug abusers.

A 2-arm feasibility cluster RCT will be conducted in the 80 drug abusers from 7 substance abuse clinics in Hong Kong Hospital Authority following the CONSORT statement. The intervention group will receive AA intervention individually from trained nursing students. The control group will individually receive a 5-minute seminar delivered by a research assistant.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 or above
* Have reported to abuse drugs within the past 30 days
* Can communicate in Cantonese and read Chinese

Exclusion Criteria:

* Unstable mental conditions that are not suitable for the intervention
* Receiving acupuncture or acupressure treatment currently or in the previous 30 days
Effect of Liraglutide for Weight Management in Paediatric Subjects With Prader-Willi Syndrome

This trial is conducted globally. The aim of this trial is to investigate the effect of liraglutide for weight management in paediatric subjects with Prader-Willi Syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
* Confirmed diagnosis of PWS (Prader-Willi Syndrome) (by genetic testing)
* Male or female, age at the time of signing informed consent: - Part A: above or equal to 12 years and less than 18 years
* Tanner stage 2-5 pubertal development for part A, and Tanner stage 1 for part B
* BMI (body mass index) corresponding to equal or above 30 kg/m\^2 for adults by international cut-off points1 and equal or above the 95th percentile for age and sex (for diagnosis of obesity)
* Stable body weight during the previous 90 days before screening ( below 10 kg self-reported weight change)
* Testing has been performed to evaluate for adrenal insufficiency and documented in medical record

Exclusion Criteria:

* Type 1 diabetes mellitus (T1DM)
* Type 2 diabetes mellitus (T2DM)
* Calcitonin equal or above 50 ng/L
* No change in treatment plan with growth hormone (GH) from randomisation to the end of the open-label period patients on growth hormone to stay on, patients off GH to stay off during this period. Adjustments in doses of growth hormone will be permitted)
* Family or personal history of Multiple Endocrine Neoplasia Type 2 (MEN2) or Medullary Thyroids Carcinoma (MTC)
* History of pancreatitis (acute or chronic)
* Treatment with any medication prescribed for weight loss within 90 days before screening (e.g. orlistat, zonisamide, topiramate/phentermine, lorcaserin, phentermine, bupropion/naltrexone,liraglutide, metformin)
* Untreated adrenal insufficiency
* Suggestive history of, or significant risk of gastroparesis (e.g. marked abdominal bloating post meal, history of vomiting, severe constipation), as judged by the Investigator