cyrilzakka/clinical-trials huggingface dataset:
Echothiophate Iodide for the Prevention of Progression of Myopia

The purpose of this study is to test the hypothesis that myopia progression can be slowed or prevented by low dose Echothiophate Iodide.

This pilot study is designed to establish proof of concept of a method to either slow or stop the progression of myopia in children between the ages of 8 and 15 years by using Echothiophate Iodide eye drops to alter the relationship between focusing (accommodation), eye alignment, and peripheral blurring. Echothiophate Iodide 0.03% eye drops have been used for years for the treatment of accommodative esotropia in children. A prospective double blind randomized study of 33 children with active development of myopia will be divided into a treatment group of 22 and a control group of 11. They will be treated for 18 weeks with four planned visits at 6 week intervals. The progression of myopia will be measured by a determination of the length of the eye (axial length measured by the IOL Master) and cycloplegic refractions. Influencing factors such as corneal changes, lens changes and macular choroidal thickness will be monitored for any significance. If successful, a larger and longer study to slow the rate of myopia with echothiophate iodide will be done in order to decrease the world's incidence of myopia currently at 25-33% in western countries and 85% in Asian countries. This would also reduce the financial burden of glasses and contact lenses as well as decrease the incidence of pathological eye disease due to high myopia.

Eligibility Criteria:
Inclusion Criteria:

* Healthy children between 8-15 years of age
* Documentation of progression of myopia within the 12 months prior to enrollment
* Written informed consent/Assent for the study

Exclusion Criteria:

* Any history of retinopathy of prematurity, glaucoma, cataracts, corneal disease, uveitis, manifest strabismus, nystagmus or ocular trauma
* Any history of unstable asthma, diabetes, or juvenile idiopathic arthritis Asthma must be stable for three months prior to enrollment if utilizing oral or inhaled steroids
* Systemic muscarinic agents, steroids, or anticholinesterase agents.
* Benzalkonium chloride preservative allergy.
* Astigmatism \>0.75D
* Anisometropia \>1.50D
* Pregnancy or a positive pregnancy test at the screening visit.
UPnRIDE Power Standing Wheelchair for SCI

People with higher level of spinal cord injury have limitations to using exoskeletal-assisted walking devices due to restrictions of trunk stability, functional use of the upper extremities and hand grip. With increasing sedentary time in wheelchairs, people with SCI have a high risk for developing secondary complications. A powered wheelchair has recently been developed for use in persons with spinal cord injury that provides a solution for placing the user in an upright, standing position while maintaining the overground mobility features of the powered wheelchair; providing the ability to engage in society in either a standing or seated position. The purpose of this study is to verify user performances of the upright powered wheelchair and to identify obstacles that are difficult, or prevent use. Additionally, the option to have upright posture throughout the day may have the potential to improve some of the secondary medical conditions associated with the extreme sedentary lifestyle.

This study will determine change from baseline after 12 weeks of use for safety, tolerance, medical, physical and quality of life outcomes. The intervention will consist of 3.5 hours per session, 3 times per week for 12 weeks. During each session, participants will be asked to stand at least 5 minutes during every 15 minutes. To our knowledge, there is no existing empirical data on intermittent standing during the day in persons with higher levels of SCI who cannot otherwise stand and whether this approach will improve health related outcomes.


Eligibility Criteria:
Inclusion Criteria:

1. Power wheelchair user as a primary means of mobility;
2. 18-89 years old;
3. ≥1 year after SCI;
4. Height of 160 to 190 cm;
5. Weight of \<100 kg; and
6. Able to sign informed consent.

Exclusion Criteria:

1. Able to ambulate with or without an assistive device or physical assistance greater than 4 consecutive steps;
2. Any pressure ulcer at any body location that is deemed to be contraindicated for a power wheelchair or standing frame by the study physician;
3. Concurrent medical disease that would be exclusionary for standing (as per the clinical judgment of the study physician);
4. Severe spasticity (Ashworth 4) or uncontrolled clonus;
5. History of fragility fractures, long bone fractures in the past 1 years, heterotrophic ossification, or other bone conditions that would be exclusionary for use of a standing modality as per the clinical judgment of the study physician;
6. Significant contractures that would be exclusionary for use of a standing modality as per the clinical judgment of the study physician
7. Psychiatric or cognitive status that may interfere with the ability to follow instruction to use the device; and
8. Pregnant or lactating women.
2D Speckle-tracking Echocardiography in Chemotherapy-induced Cardiomyopathy With Cardiovascular Risk Factors

The aims of this study is to evaluate the role of 2D speckle-tracking echocardiography in diagnosis chemotherapy related left ventricular dysfunction in breast cancer patients with cardiovascular risks

Chemotherapy induced cardiomyopathy is a serious adverse effect of anticancer treatments with poor long-term prognosis. In addition to the cumulative dose of anthracycline and trastuzumab, cardiovascular risks have been proven to be the "second hit" when dealing with chemotherapy related cardiomyopathy in breast cancer patients. Speckle-tracking echocardiography have had robust evidence in diagnosis the early stage of left ventricular dysfunction in various types of cancer treated by cardiotoxicity drugs. However, data is still lacking regarding the role of speckle-tracking echocardiography in breast cancer patients with cardiovascular risk

Eligibility Criteria:
Inclusion Criteria:

* Breast cancer patients treated by anthracycline and/or trastuzumab
* Have at least one of these cardiovascular risks: age \> 60, hypertension, atrial fibrillation, diabetes mellitus, dyslipidemia, chronic kidney disease, obesity, family history of cardiovascular diseases.

Exclusion Criteria:

* Left ventricular ejection fraction \< 50% before chemotherapy
* Chronic heart failure with NYHA functional class \>= II
* Significant valvular stenosis/regurgitation
* Acute heart failure due to acute coronary syndrome during follow-up
Mini Gastric Bypass vs Roux enY Gastric Bypass

The primary aim of this research project is to assess the safety and efficacy of the MGB operation in the UK

The main aim of this project is to develop an ideal bariatric/metabolic surgery operation.

The ideal features are highly safe operation, revisable, reversible, extremely effective, short operative time, short hospital stay, cost-effective, no long-term complications and acceptable to the patients.

Mini Gastric Bypass/One Anastomosis Gastric Bypass MGB/OAGB is relatively a new bariatric /metabolic surgery operation that is increasing in popularity and currently more than 60,000 operations are performed worldwide. Only 125 MGB operations are published from UK.

No previous RCT to date in the UK to test the new operation although RCT was done in Taiwan 2005 and showed that MGB is not inferior to the Roux EnY Gastric Bypass RYGB. This research project is assessing the outcomes of this operation and opening the doors to understand its effects and how it works compared to the standard RYGB. The possible development in the project is to study the hormonal changes after the MGB.

Eligibility Criteria:
Inclusion Criteria:

* They have a BMI of 40 kg/m2 or more, or between 35 kg/m2 and 40 kg/m2 and other significant disease (for example, type 2 diabetes or high blood pressure) that could be improved if they lost weight.
* All appropriate non-surgical measures have been tried but the person has not achieved or maintained adequate, clinically beneficial weight loss.
* The person has been receiving or will receive intensive management in a tier 3 service.
* The person is generally fit for anaesthesia and surgery.
* The person commits to the need for long-term follow-up

Exclusion Criteria:

* Not meeting the eligibility criteria
* Under 18s
Bryostatin 1 in Treating Patients With Relapsed Multiple Myeloma

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of bryostatin 1 in treating patients with relapsed multiple myeloma.

OBJECTIVES: I. Determine the efficacy of bryostatin 1 administered as a 72-hour continuous infusion in patients with relapsed multiple myeloma. II. Determine the qualitative and quantitative toxic effects of bryostatin 1 in these patients. III. Determine the duration of response and survival following bryostatin 1 in these patients.

OUTLINE: All patients receive bryostatin 1 by 72-hour continuous infusion every 2 weeks until disease progression or 2 courses beyond complete remission. Response is assessed after every 4 courses. Patients are followed for survival.

PROJECTED ACCRUAL: A total of 15-25 evaluable patients will be entered into this study over 1.25 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Multiple myeloma of any stage that has failed 1 or 2 prior regimens (chemotherapy, biologic therapy, or both, or bone marrow transplantation) Evidence of disease progression required Ineligible for known treatment of higher potential efficacy One of the following protein criteria required: Quantifiable M-components of IgG, IgA, IgD, or IgE Urinary kappa or lambda light chain (Bence-Jones protein) excretion Re-treatment on this protocol allowed if disease relapsed after a complete remission

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count greater than 1,500/mm3 Platelet count greater than 50,000/mm3 Hepatic: Bilirubin less than 1.5 mg/dL Transaminases less than 2.5 times normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Cardiovascular: No history of impaired cardiac status, e.g.: Severe coronary artery disease Cardiomyopathy Congestive heart failure Arrhythmia Other: No known AIDS or HIV infection No second malignancy within 5 years except: Adequately treated nonmelanomatous skin cancer Carcinoma in situ of the cervix No pregnant or nursing women Effective contraception required of fertile patients during and for 2 months after study

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: See Disease Characteristics At least 4 weeks since chemotherapy (8 weeks since mitomycin or nitrosoureas) and recovered Endocrine therapy: No concurrent steroids Radiotherapy: At least 4 weeks since radiotherapy and recovered Surgery: Not specified
Study to Assess the Tolerability, Safety and Efficacy of an Adapted Gut Cleansing Solution in Routine Colon Cleansing Prior to Colonoscopies

It is particularly important that thorough gut cleansing is achieved prior to the colonoscopy for the procedure to be successful. Polyethylene glycol plus electrolyte (PEG+E) solutions are well established as safe and effective agents for gut cleansing and Norgine has successfully developed a low volume (2 litre) PEG+E gut lavage solution. The efficacy and safety of this solution is similar to the standard 4 litre PEG+E, but with improved patient acceptance.

Tolerance, acceptability and satisfaction with the cleansing agent plays an important role in subjects' compliance with gut preparation procedure. The study medication NRL0706 is identical to the PEG+E-containing gut lavage solution commonly used in clinical practice, with the exception that the flavour has been modified from lemon to orange. This study is to investigate the tolerability, acceptability, safety and efficacy of a single dose of NRL0706 (MOVIPREP Orange) in subjects without gastrointestinal symptoms undergoing colonoscopy for colon cancer screening.


Eligibility Criteria:
Inclusion Criteria:

* The subject's written informed consent must be obtained prior to inclusion.
* Male or female ambulatory subjects aged between 40 to 75 years undergoing a complete colonoscopy for colon cancer screening.
* No history of significant gastrointestinal diseases, including gastrointestinal obstruction and perforation or acute symptoms requiring a colonoscopy procedure.
* Willing to undergo a colonoscopy for colon cancer screening.
* Willing, able and competent to complete the entire procedure and to comply with study instructions.
* Females of childbearing potential must employ an adequate method of contraception.

Exclusion Criteria:

* History of gastric emptying disorders
* History of ileus, toxic megacolon, gastrointestinal obstruction and colonic perforation
* History of Phenylketonuria
* Known Glucose-6-phosphate dehydrogenase deficiency
* Known hypersensitivity to macrogol 3350, sodium sulphate or ascorbic acid/ sodium ascorbate
* History of colonic resection
* Requirement for permanent medication and associated stable serum concentrations (e.g. neuroleptic drugs)
* Presence of congestive heart failure (NYHA III + IV)
* Acute life-threatening cardiovascular disease
* Documented history of severe renal insufficiency
* Application of any unlicensed medication within the previous 3 months or participation in any other research study in the last 3 months
* Females who are pregnant, nursing or planning a pregnancy. Females of child bearing potential not using reliable methods of contraception
* Subjects who the investigator feels would not be compliant with the requirements of the trial
Progress Adult Study

The purpose of this study is to study the HIV disease progression in HIV-infected Thai Adult.

This is a multicenter, observational prospective cohort study. All HIV-infected patients from Bamrasnaradura Institute, Sanpatong Hospital and HIV-NAT, Thai Red Cross AIDS Research Centre, are followed to assess HIV disease progression.

Eligibility Criteria:
Inclusion Criteria:

1. There is evidence that HIV infection true (blood positive results by ELISA (ELISA) has been confirmed or detected evidence co-infection. HIV in the body by PCR, HIV-RNA PCR).Currently on PI regimens
2. Signed consent form
3. Age\> 18 years

Exclusion Criteria:

1. Patients who came for treatment in a department other than out patient, such as inpatient or emergency room.
2. Patients are not willing to receive treatment on a regular basis in all 3 hospitals as patients normally receive treatment at other hospitals on a regular basis. However, due to urgent events. Need to receive treatment in hospital and three of.
3. Patients who have been diagnosed by doctors as a Psychological disorder that can not store the data.
4. Patients who have been diagnosed by a medical condition that Alcoholism
Repetitive Transcranial Magnetic Stimulation With H-coil in Alzheimer's Disease

Focal repetitive transcranial magnetic stimulation (rTMS) has been applied to improve cognition in Alzheimer's disease (AD) with conflicting results. In this study we aimed to explore feasibility, safety and efficacy of excitatory rTMS of bilateral DLPFC applied with H-coil in AD in a pilot randomized, placebo-controlled, double-blind study.

Study Design The study was a double-blind, placebo-controlled paradigm, with randomization into a real rTMS group or a sham rTMS

Eligibility Criteria:
Inclusion Criteria:

* Ability to understand the purpose and risk of the study and provide signed and dated informed consent.
* Male or female subjects, 18 to 80 years old.
* Diagnosis of Alzheimer's disease according to the DSM IV
* Subjects who answered all questions in the TMS pre-treatment safety questionnaire in a negative manner.
* Have given written informed consent

Exclusion Criteria:

* Presence of an additional neurological or psychiatric pathology.
* Severe personality disorder.
* Uncontrolled hypertension.
* History of epilepsy, seizures, febrile convulsions.
* History of epilepsy or seizures in first degree relatives.
* History of head injury or stroke.
* Presence of metal prostheses in the head (except dental fillings).
* Metal implants or known history of any metal particles in the eye, cardiac pacemakers, cochlear implants, use of neurostimulators or medical pumps.
* History of migraine within the past six months.
* History of drug or alcohol abuse.
* Impossibility of adequate communication with the examiner.
* Participation in another clinical study, either concomitant or within the previous 3 months.
* Inability to sign the consent form.
To Evaluate the Inflammatory Markers in Adult Patients With Asthma Associated With Allergic Rhinitis Receiving Montelukast Therapy (0476-366)

To evaluate the changes in proinflammatory markers (ltd4 in urine) and eosinophil from peripheral blood after newly initiated montelukast therapy.


Eligibility Criteria:
Inclusion Criteria:

* Allergic rhinitis symptoms: sneezing, rhinorrhea, obstruction of the nasal passages, itchy nose and throat, and conjunctival
* Male or female outpatient 20 years of age and older
* Patients with the following signs and symptoms of asthma and allergic rhinitis: history of cough, wheezing, shortness of breath, positive methacholine bronchoprovocation test

Exclusion Criteria:

* Active, acute or chronic, pulmonary disorder (besides asthma) documented by history, physical examination, or chest x-ray. history of anaphylactic or hypersensitive to study drug
* Requires oral, intravenous, or intramuscular corticosteroids on daily routine basis
* Started on immunotherapy within six months before the pre-study visit and/or the dose of immunotherapy is expected to change over the course of the study
* Treated with montelukast within 3 months before enrollment
* Unable to perform acceptable, reproducible spirometry and peak flow measurement
* Unresolved symptoms and signs of an upper respiratory tract infection (uri) within 2 weeks prior to visit 1
Stomaplasty Ring (KoringTM) for Prevention of Parastomal Hernia

Parastomal hernia (PSH) is one of the most frequent stoma complications with a high impact on patients' quality of life. Half of the stomas created each year are permanent and up to 50% of the patients will develop a PSH. PSH rates depend on the type of ostomy, ileo- or colostomy. End colostomy carries the highest risk for PSH (48%). PSH lead to recurrent pain, poor fitting appliance with leakage and therefore, skin irritation, and can also be complicated by strangulation or occlusion. The literature reports that 30% of patients with a PSH will require surgery. There are many different surgical procedures to repair PSH: primary fascia repair, relocation of the stoma or repair with various type of mesh. Despite the efforts done to improve the techniques, the incidence of recurrent PSH is up to 70% dependent of the used technique. Therefore, the idea of implanting a mesh at the time of initial stoma formation has lately been advocated. A new device, the KoringKM, which is a stomaplasty ring made of propylene, flexible and non-absorbable, was created. This study will try to prove that incorporation of the new stomaplasty ring at the time of stoma creation will diminish long-term PSH rate. This hypothesis will improve patient's quality of life and reduce costs associated with PSH.

All patients requiring a permanent ostomy (ileostomy or colostomy) for a malignant disease and fulfilling the inclusion criteria are eligible to participate in the trial. The patients will be randomized 24 to 48 hours prior to surgery after given written informed consent. The implantation of the Koring will be perfomed by experienced surgeons (expertise based, best team approach) who have already implanted the Koring (e.g. participated in the observational study) and/or have reviewed the video documentation. The surgeon will fill out the first form with the data of the patient and of the surgical procedure. The surgical wound will be daily examined. A second form will be fill out during the 30 post-operative days visit. The patients will be asked to inform the surgeon and/or investigator if any side event or suspicion of infection occurs after hospital discharge. The next follow-up visits will be at one and two years including a clinical examination and an abdominal CT. At this moment, the 3rd and 4th forms will be documented. All data will be anonymised and included in an Excel database.


Eligibility Criteria:
Inclusion Criteria:

* Patients requiring permanent ostomy (ileo- or colostomy) for a malignant tumour with at least one year life expectancy
* Patient is able to cooperate
* Patient has given written informed consent
* Age equal or greater than 18 years

Exclusion Criteria:

* Life expectancy \< 1 year
* Palliative surgery
* Benign disease
* Factors impacting on the ability to cooperate
* Mental disorders
* Pregnant or breastfeeding women
* Participation in another intervention trial with interference of intervention and outcome of this study
* BMI \< 18
Effectiveness of a Hand-held Fan for Breathlessness

Breathlessness is a common and distressing symptom in advanced disease. A hand-held fan is a simple device which has shown, when directed to the patients face, to be effective in relieving breathlessness.

This phase II trial aims to determine the potential effectiveness of a hand-held fan to relieve breathlessness over time and to evaluate the recruitment into the study and the acceptance of the intervention and the control.

The intervention to be tested is a HHF directed to the area of the face innervated by the second and third trigeminal nerve branches. A wristband was chosen as control under the assumption that distraction could serve as a placebo.

The main outcomes for this study are uptake into the trial (proportion of patients from the longitudinal study participating in the RCT), adherence to the study, and use and acceptance of the intervention and the control. The main outcome for assessing the effect of the hand-held fan is change of severity of breathlessness between baseline and one month and two months, respectively.


Eligibility Criteria:
Inclusion Criteria:

* Patients were included if they reported breathlessness that had an impact on their daily life and were suffering from one of the following conditions:
* Advanced malignant disease (primary lung cancer or secondary lung metastases/ lung involvement due to cancer)
* COPD stage III (severe) and IV (very severe) according to GOLD criteria.\[7\]

Exclusion Criteria:

* Unable to provide informed consent
* Too ill to be interviewed and not fluent or illiterate in German
24-hr Intraocular Pressure Control With Dorzolamide/Timolol vs the Brimonidine/Timolol Fixed Combination

The proposed study will compare for the first time the quality of 24-hour IOP control with Brimonidine/Timolol fixed combination (BTFC) versus Dorzolamide/Timolol fixed combination (DTFC) after a run-in period of 2 months with timolol. This crossover comparison may determine the real efficacy of the two fixed combinations and the design of the proposed study may explain for the first time why the 24-hour IOP reduction provided by BTFC is less than might be anticipated.


Eligibility Criteria:
Inclusion Criteria:

* Consecutive, newly diagnosed or previously untreated POAG patients
* Patients with typical glaucomatous disc, or visual field damage
* Patient must have IOP (at 10:00 ± 1 hour)greater than 25 mm Hg

Exclusion Criteria:

* Uncontrolled glaucoma
* Distance best corrected Snellen visual acuity worse than 1/10
* Contraindications to brimonidine or dorzolamide and β-blockers
* History of lack of response (\<10% morning IOP reduction) to any medication
* Patient can not understand the instructions and adhere to medications
* Patient is a female of childbearing potential or lactating mother
* Prior surgery, past use of steroids (within 2 months)
* Severe dry eyes and use of contact lenses
* History of non-adherence
* Patients with closed angles