cyrilzakka/clinical-trials huggingface dataset:
Treatment of Residual Amblyopia With Donepezil

Amblyopia is the leading cause of monocular visual impairment in children and adults. Despite conventional treatment with patching or eye drops, many older children and adults do not achieve normal vision in the amblyopic eye.

Donepezil is an acetylcholinesterase inhibitor that increases levels of the neurotransmitter acetylcholine in the brain. Use of acetylcholinesterase inhibitors has been demonstrated by the Hensch lab (Department of Neurology, FM Kirby Neurobiology Center) at Boston Children's Hospital to improve vision and reverse amblyopia in animal models.

The purpose of this study is to evaluate the efficacy of oral donepezil as treatment for residual amblyopia (20/50 - 20/400) in patients 8 years of age and older.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥8 years
2. Amblyopia associated with strabismus and/or anisometropia
3. Amblyopic eye visual acuity of 20/50 - 20/400
4. Sound eye visual acuity of ≥20/25
5. For 8 to 17 year olds, current amblyopia treatment of at least 2 hours of daily patching for at least 4 weeks during the pre-enrollment period with no improvement in best-corrected amblyopic eye visual acuity (\<5 letters or 1 logMAR line between 2 consecutive visual acuity measurements at least 4 weeks apart while on current treatment)
6. For ≥18 year olds, history of prior amblyopia treatment with patching
7. Wearing optimal optical correction with stable amblyopic eye visual acuity (\<5 letters or 1 logMAR line of improvement during 2 consecutive visual acuity measurements at least 4 weeks apart)
8. Complete eye examination within 6 months prior to enrollment
9. Available for at least 6 months of follow-up, have access to a phone, and willing to be contacted by clinical staff
10. Likely to comply with prescribed treatment and unlikely, if applicable, to continue to improve with 2 hours of daily patching alone

Exclusion Criteria:

1. Myopia more than -6.00 D spherical equivalent
2. Presence of associated findings that could cause reduced visual acuity
3. Previous intraocular or refractive surgery
4. Strabismus surgery planned within 22 weeks
5. Current vision therapy or orthoptics
6. Treatment with topical atropine within the past 4 weeks
7. Presence of cardiac condition, asthma, obstructive pulmonary disease, seizure disorder, urinary incontinence, and/or peptic ulcer disease receiving concurrent NSAIDs
8. History of gastrointestinal bleeding from peptic ulcer disease
9. Known psychological problems
10. Known skin reaction to patch or bandage adhesives for 8 to 17 year olds
11. Known allergies or contraindications to the use of acetylcholinesterase inhibitors
12. Prior acetylcholinesterase inhibitor treatment
13. Current use of medication for the treatment of ADHD or psychological disorders
14. Inability to swallow pills equivalent in size to the 5 mg donepezil tablet
15. Females who are pregnant, lactating, or intending to become pregnant within the next 6 months
Use of Alternative Medicine in Patients With Dementia and Mild Cognitive Dysfunction

So far, no drugs have shown to stop or delay the pathological processes of dementia. Available pharmacological treatment includes a small number of drugs; cholinesterase inhibitors like donepezil, galantamine and rivastigmine, and the NMDA receptor antagonist memantine, all of which only affect the symptoms of the disease. At the same time, alternative medicines like herbal products and dietary supplements are often intensively marketed with the assertion of curative or alleviating effects on dementia. The documentation of clinical effects, side effects and the potential for interaction with prescribed drugs are, however, generally scarce. The aims of this study are to make a survey of the use of alternative medicine in patients with dementia and mild cognitive dysfunction attending the investigators out-patient dementia clinic, and to assess the interaction potential with the patient's other medications.

Patients: All patients with a diagnosis of dementia under follow-up at the out-patient clinic are invited to participate, if giving a written consent.

Method: a semi-structured interview is undertaken by the doctor at the end of the consultation. Patients and their company are asked to name their alternative medicines (if any), for how long the products have been used, where and how they learned about the products, ant to tell about their experiences with the products (i.e if they have noticed effects or side-effects). After the consultation information of the the actual product's contents and properties are obtained and an assessment of possible interactions with the patient's other drugs (prescriptions and self-reported use of over-the-counter drugs) is made. Reported effects or side-effects are registered.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with dementia
Effect of Probiotics in Patients Undergoing Surgery for Periampullary Neoplasms

The purpose of this study is to evaluate the effect of the probiotic use in patients with periampullary cancers undergone curative or palliative treatment considering nutritional status, postoperative complications, infection rate, length of hospitalization and mortality.


Eligibility Criteria:
Inclusion Criteria:

* Patients in need of surgery for periampullary cancer

Exclusion Criteria:

* Patients submitted to periampullary surgery without pathologic confirmation of cancer
* Patients unwilling to be a part of the trial
Evaluation of a Pre-surgical Virtual Reality Simulation for Cancer Surgery Patients

This study will pilot test and explore the feasibility of a virtual reality simulation of the operating room environment to reduce anxiety/distress in cancer surgery patients. Study objectives are to evaluate recruitment and data collection procedures, outcome measures, participant feedback on the virtual reality operating room intervention, and the inclusion of a treatment as usual group, and effects of the intervention on symptoms of anxiety/distress. Results of this study will inform the design of an upcoming larger-scale RCT to assess the efficacy of this intervention


Eligibility Criteria:
Inclusion Criteria:

* Over the age of 18
* Can speak and read English
* Has a cancer diagnosis
* Scheduled/being scheduled to undergo cancer surgery under general anesthesia at the Health Sciences Centre (Winnipeg, MB)

Exclusion Criteria:

* Those who do not meet any inclusion criteria
* Those who are not competent to provide informed consent (e.g., due to cognitive impairment)
* Those who are unable to participate in a virtual reality intervention (e.g., due to visual/auditory impairment)
Onsite vs. Virtual Group Fitness in Overweight/Obese Women

The purpose of this study is to compare an onsite to virtual whole-body high intensity interval training (HIIT) program on anthropometric variables, aerobic fitness measures, and vascular markers of cardiac risk in a single study of overweight and obese women.


Eligibility Criteria:
Inclusion Criteria:

* Premenopausal adult females over the age of 18 and under the age of 45 with a BMI greater than or equal to 25 and a waist circumference greater than or equal to 35 inches.
* No medical contraindications to participation in an exercise program including major medical illnesses (i.e. cardiovascular disease, stroke, cancer, etc.)
* Ability to provide informed consent
* Willingness and ability to participate in an interval training in-person group fitness exercise program 3x/week for 12 weeks

Exclusion Criteria:

* Adults unable to consent or mini-mental score less than 18.
* Individuals who are not yet adults (infants, children, teenagers)
* Pregnant women
* Post-menopausal women
* Do not speak English
* Prisoners
* Subjects on medicines (serum glucose, insulin, weight loss medicines, beta-blockers) and having any medical pre-conditions that would interfere with one's capacity to exercise.
* Answer "Yes" to any of the questions on the Pre-Activity Screening Questionnaire (PASQ)
Can Malnutrition be Prevented in Patient With Colorectal Cancer Stage Dukes D?

The purpose of this randomised intervention study is to investigate to what degree patients with colorectal cancer benefit of dietary counselling regarding nutritional status, oncologic treatment and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* metastatic colorectal cancer
* histological verified cancer
* age \>18 years

Exclusion Criteria:

* cognitive reduction
* confusion
* not able to answer questionaire
The Use of Sensory or Motor Cues Using Electrical Stimulation to Reduce Gait Freezing in Patients With Parkinson Disease

Some individuals with Parkinson disease experience "freezing" during walking which results in their inability to move their feet. They often have difficulty starting to move once they have stopped. Freezing often results in loss of balance and falling. Oral medications for Parkinson disease aren't as effective in treating freezing as it is in reducing other symptoms. Another treatment for freezing is instruction in walking using visual targets or auditory cues (thinking of a rhythm or beat). These cues can be initially effective for some individuals, but the effects do not last. Other types of cues have not been studied. We want to examine the effects of two other cues, tactile (touch) or motor (muscle contraction), on the effects of freezing.

We will use a device (TENS unit) that provides electrical stimulation to a nerve in the lower legs. Electrodes will be placed on the skin of your lower legs and a box that delivers electrical current will cause a tingling feeling in the legs. Subjects will be asked to perform three gait tasks with the device on and off to compare the effects of the sensory cue on the speed/time to complete gait tasks and the frequency and duration of any freezing events. This use of the device (TENS unit) is investigational. While it has been approved by the Food and Drug Administration for the treatment of pain, it has not been approved for the treatment of freezing. Because the TENS unit can provide a sensory cue, it may help to prevent or reduce freezing. If it is found that this cue works, it could lead to new treatments for the treatment of freezing.

Eligibility Criteria:
Inclusion Criteria:

1. PD diagnostic criteria include those used for clinically defined "definite PD", as previously outlined22 based upon established criteria.22, 23
2. history of consistent freezing with ambulation in a straight line and/or when turning.
3. normal central and peripheral neurological function
4. at least grade 4 strength and normal joint ranges of motion in both legs
5. normal somatosensory function in the feet (joint position sense), except for their neurological diagnosis and use of levodopa.
6. Each must have had clear benefit from levodopa for at least some of his/her PD symptoms
7. All subjects with PD must be able to walk independently for 10 feet.

Exclusion Criteria:

1. serious medical problem that would impair the ability to undergo testing.
2. use of neuroleptic or other dopamine-blocking drug
3. use of drugs that might affect balance
4. history or evidence of other neurological deficit that could interfere, such as previous stroke or muscle disease
5. participants who are unable to provide informed consent
Human Leukocyte Antigen Class II (DRB1 and DQB1) Alleles and Haplotypes Frequencies in Patients With Pemphigus Vulgaris Among the Russian Population

Pemphigus is a rare autoimmune life-threatening blistering condition affecting skin and mucous membranes. Pemphigus belongs to a family of polygenic disorders. Several different genes encoding molecules regulate pemphigus autoimmunity. Many trials focused on HLA investigation. Increased levels of certain HLA class II alleles frequencies in pemphigus have been reported in various populations. However, they were not investigated in the Russian population.

The aim of our study is to investigate HLA class II alleles and haplotypes in Russian patients with pemphigus.

Methods

Patients and controls

We are recruiting 120 patients with pemphigus. The diagnosis was based on clinical and histopathological findings and confirmed by immunofluorescent techniques (direct and indirect immunofluorescent tests). Before sampling, written consent was obtained from each subject. A single blood sample for HLA typing was obtained from all subjects. This study has been approved by the Ethics Committee of Sechenov University, Russia. Phenotypic and allelic frequencies were compared with healthy blood donors (n=100) registered in Sechenov University blood center.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Age of patients \>18 years
* Confirmed diagnosis

Exclusion Criteria:

* No as pemphigus is a life-threatening condition
Subcutaneous Immunoglobulin Treatment of Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)

The purpose of this study is to determine whether subcutaneous immunoglobulin given in small doses, is effective in maintaining the force, in patients with chronic inflammatory demyelinating polyradiculoneuropathy compared with placebo (saline infusions), and intravenous immunoglobulin.

CIDP is an autoimmune disease of the peripheral nervous system, responding well to treatment with intravenous immunoglobulin (IVIg), steroids and plasmapheresis. IVIg is effective in treating patients with CIDP, but most of the patients need long time maintenance treatment, which is associated with decreased autonomy and regular hospital admissions. Furthermore many of the patients complain of infusion related side effects such as headache, chills and fatigue, and over time there is problems obtaining intravenous entry because of occlusion of the veins.

There is therefore a critical need for alternative methods to IVIg treatment. The aim of this study is to evaluate the efficacy, tolerability and safety of small doses of immunoglobulin administered subcutaneously (SCIg), compared with placebo. At the same time we compare the efficacy of SCIg with the regular IVIg treatment.

We therefore hypothesize, 1: SCIg is better than subcutaneous placebo infusions, and is as good as IVIg in maintaining muscle function in patients with CIDP. 2: SCIg home treatment is safe and tolerable. 3: SCIg home treatment is preferred to IVIg under hospital admission, by the patients.

Eligibility Criteria:
Inclusion Criteria:

* All patients with typical or pure motor CIDP, who meet the clinical or electrophysiological criteria of the EFNS/PNS for certain or probable CIDP and who are in regular treatment with IVIg on one of the neurological departments in Denmark, are eligible for the study

Exclusion Criteria:

* Pregnancy
* Known cancer disease
* Severe medical diseases
* Other immuno modulating treatment than low-dose steroid (prednisolone \< 25 mg/day) within the last 6 weeks before inclusion
* Hepatitis B or C or HIV
* Breast-feeding
* Non-responding to treatment with intravenous immunoglobulin
* Known hypersensitivity to intravenous immunoglobulins or Kiovig

Adverse events:

* Previous moderate headache or minor rash for a few days during or after infusion is not an exclusion criteria
* In case of severe adverse effects to treatment patients are excluded. Moderate or mild side-effects can be treated with analgetics or steroids for 1-2 weeks during the initial study phase
The Combined Antibiotic Therapy for Carbapenem Resistant Klebsiella Pneumoniae

The infection of carbapenem resistant klebsiella pneumoniae (CRKP) is increasingly serious.Based on the early experimental basis and relevant research background,this study intends to separate and purify the CRKP from the bronchoalveolar lavage fluid (BALF) of the clinical patients.Designed by checkerboard assay and time-kill assay(TKA)，this study can explore the best combination therapy based on carbapenems.

1. Collect the BALF from patients diagnosed with CRKP infection in surgical intensive care unit（SICU）of Shanghai 10th people's hospital.
2. Separate and purify the BALF. Divide each CRKP into four treatment groups based on meropenem.

3.1 By checkerboard method and microdilution broth method,get the minimal inhibitory concentration (MICS) of two antibiotics,then calculate the fractional inhibitory concentration (FIC) index according to MIC results.

3.2 Observe the effect of two antibiotics on the growth of CRKP by TKA.

4.By the above two invitro experiments, analyze the data of the experimental results and get the best combination therapy based on carbapenems.

Eligibility Criteria:
Inclusion Criteria:

* age from 18 to 90.
* infected with CRKP firstly .

Exclusion Criteria:

* APACHE II score \> 35
* Vital signs are unstable
* Unable to tolerate fiberoptic bronchoscopy
Photodynamic Therapy in Treating Patients With Skin Cancer

RATIONALE: Photodynamic therapy uses light and drugs that make cancer cells more sensitive to light to kill tumor cells. Photodynamic therapy using aminolevulinic acid cream may be effective in treating patients with skin cancer.

PURPOSE: This randomized phase II trial is studying how well photodynamic therapy works in treating patients with skin cancer.

OBJECTIVES:

* Characterize the penetration of topically applied aminolevulinic acid (ALA) into the lesions of patients with primary basal cell and squamous cell carcinomas.
* Quantitate the depth of fluorescence achievable with varying application periods of ALA in these patients.
* Compare the results of tissue fluorescence with surface fluorescence measurements in these patients.

OUTLINE: This is a randomized study. Patients are stratified according to lesion type (superficial basal cell carcinoma (BCC) vs nodular BCC vs squamous cell carcinoma). Patients within each group are randomized to receive one of two application times: 4-5 or 20-24 hours in duration.

Aminolevulinic acid is topically applied either in a cream mixture or an alcohol base and an occlusive dressing placed over the lesion. After the randomized treatment duration has expired, the dressing is removed and quantitative protoporphyrin IX fluorescence measurements from the tumor and surrounding skin are mapped using a fluorometer. Routine surgical excision is then performed on the carcinoma.

Patients return after one to two weeks for a follow-up examination and suture removal.

PROJECTED ACCRUAL: 54 patients will be accrued within 10 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically proven basal cell carcinoma or squamous cell carcinoma
* Candidate for complete surgical excision

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* Not specified

Renal:

* Not specified

Other:

* No inflammation or infection of treated area

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* Not specified

Endocrine therapy:

* Not specified

Radiotherapy:

* Not specified

Surgery:

* Biopsy at least 2 weeks prior to surgery
Exercise Inhibit Innate Immune Response and Ameliorate Chronic Pancreatitis

The goal of this observational study is to learn about the effects of different physical exercise on disease progression in patients with chronic pancreatitis. The main question it aims to answer is:

Can physical exercise alleviate the disease progression of chronic pancreatitis?

Currently, the investigators have followed up with participants through a telephone questionnaire for six months to investigate whether the participants have engaged in physical exercise and to assess the disease progression of chronic pancreatitis.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of chronic pancreatitis
* Must be adhere to the guidelines of the American Gastroenterological Association

Exclusion Criteria:

* Autoimmune pancreatitis
* Pancreatic cancer diagnosed within 2 years after the onset of CP
* Use of drugs or toxins, or presence of viral infections
A Randomized Controlled Trial Comparing the Effectiveness of Different Treatment Options for Weight Management After Discontinuation of Semaglutide and Tirzepatide (GLP1 Transition Trial)

The study compares the effectiveness of treatment options for weight management after discontinuing semaglutide and tirzepatide. The primary outcome is absolute and percentage weight change at 12-weeks.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Previous hx of BMI of \>30 or BMI of \>27 with one or more weight related medically qualifying condition (hypertension, dyslipidemia, sleep apnea, cardiovascular disease)
* Currently taking Wegovy, Ozempic, Mounjaro or Zepbound and have been for at least 6 months
* At least 15% body weight loss since taking Wegovy, Ozempic, Mounjaro, or Zepbound
* Willing to stop taking their GLP-1 medication or is discontinuing due to circumstances such as access, cost, coverage, choice, or any other reason
* Ability to provide informed consent prior to any trial-related activities
* Able to read and write in English

Exclusion Criteria:

* BMI \<26 kg/m2
* Diabetes
* Previous surgical obesity treatment
* Currently pregnant or intending to become pregnant during the study
* Not using highly effective contraception during the study period and for 3 months after
* Breastfeeding
* History of seizures or epilepsy
* Current opioid use or in acute opioid withdrawal
* Abrupt discontinuation of alcohol, benzodiazepines, barbiturates, antiepileptic drugs
* History of glaucoma
* Uncontrolled hypertension
* Severe renal impairment and/or Chronic kidney disease stage III or GFR \<60
* Acute hepatitis or liver failure
* Acute or chronic metabolic acidosis, including diabetic ketoacidosis
* Use of antipsychotic medications or opiod analgesics
* Current or previous history of anorexia or bulimia nervosa
* Engagement with vomiting or laxative use within the last 28 days with the aim of controlling their shape or weight
* Current SSRI, SNRI, mood stabilizer, amphetamine, or corticosteroid use
* Current diagnosis of hyper or hypothyroidism or current use of thyroid replacement medicine
* Current use of beta blockers
* Current use of depo shot (medroxyprogesterone acetate) for birth control
* Current diagnosis of Cushing's disease or syndrome
* Current use of Monoamine Oxidase Inhibitors (MAOIs)
* Known hypersensitivity to bupropion, naltrexone, or metformin
* Any other reason rendering a participant unsuitable for trial participation, as determined by a clinician or study investigator