cyrilzakka/clinical-trials huggingface dataset:
Macular Hole After Diabetic Vitrectomy

To present the clinical characteristics and rational treatment of macular hole (MH) after the diabetic vitrectomy (DV) in patients with proliferative diabetic retinopathy (PDR).

All patients had received initial vitrectomy to treat complications of PDR. Recruited patients were divided to two groups: the persistent MH group, who had MH before the primary DV (group 1); and the newly-developed MH group, who developed MH after a successful primary DV (group 2). The patients' demographic data, records of ophthalmological examinations, and surgical procedures were collected, including best-corrected visual acuity before and after each operation, fundus changes, as well as MH repairing techniques. The extent of fibrovascular proliferation(FVP) was separated into four grades based on the severity of vitreoretinal adhesion : multiple-point adhesions with or without one site plaque-like broad adhesion (grade 1), broad adhesions in more than one but fewer than three sites, located posterior to the equator (grade 2), broad adhesions in more than three sites, located posterior to the equator or extending beyond the equator within one quadrant (grade 3), and broad adhesions extending beyond the equator for more than one quadrant (grade 4). The extent of retinal detachment (RD) was classified into "within the arcade" or "beyond the arcade". The macular structure was evaluated by optical coherence tomography (OCT). All patients had a follow-up duration of more than three months after the final surgical procedures.

Three different surgical techniques were used to treat MH: standard internal limiting membrane (ILM) peeling, inverted ILM flap insertion into the MH, and lens anterior or posterior capsular flap insertion into the MH. The indication(s) for each technique were:

standard ILM peeling was performed if no ILM peeling had been done in the previous surgery, and the MH size was less than 500um in an attached retina; inverted ILM flap insertion was performed if no ILM peeling had been done in the previous surgery, with a detached retina; lens anterior capsule flap insertion was performed if cataract surgery was performed in the same setting with no ILM tissue available; lens posterior capsule flap insertion was performed in a pseudophakic eye with no ILM tissue available. Only descriptive statistics was obtained.

Eligibility Criteria:
Inclusion Criteria:

* Proliferative diabetic retinopathy patients presenting with macular hole after primary diabetic vitrectomy
* The persistent MH group after surgery, who had MH before the primary DV
* Newly-developed MH group, who developed MH after a successful primary diabetic retinopathy

Exclusion Criteria:

* Patients with peripheral breaks
* Patients with macular hole before surgery, which closed after primary diabetic retinopathy
* Missing clinical data
A Study to Investigate the Safety and Efficacy of Ripasudil (K-321) Eye Drops After Cataract Surgery

The purpose of this study is to assess the safety and efficacy of K-321 in subjects after cataract surgery


Eligibility Criteria:
Inclusion Criteria:

* Is at least 18 years old at the screening visit (Visit 1).
* Is planning to undergo cataract surgery in the study eye and has had cataract surgery at Visit 2.
* Can understand the written informed consent, provides signed written informed consent, and agrees to comply with protocol requirements before any study-specific assessment is performed.
* Meet all other inclusion criteria outlined in clinical study protocol.

Exclusion Criteria:

* Is a female subject of childbearing potential and any of the following is true:

  1. is pregnant or lactating/breastfeeding, or
  2. has experienced menarche and is not surgically sterile, not post-menopausal (no menses for the previous 12 months), or not willing to practice an effective method of birth control during the study period as determined by the Investigator (eg, oral contraceptives, double barrier methods, hormonal injectable or implanted contraceptives, tubal ligation, or partner with vasectomy).
  3. has a positive urine pregnancy test result at Visit 2 before cataract surgery.
* Had intraocular surgery (non-laser surgery) in the study eye within 6 months of Visit 1.
* Had intraocular laser surgery in the study eye within 3 months of Visit 1.
* Meet any other exclusion criteria outlined in clinical study protocol
Immune Fitness Prediction

The overall objective of the study is to determine whether self-rated, perceived immune fitness (using questionnaire) is associated with biological assessment of immune fitness (immune signatures in the blood).


Eligibility Criteria:
Inclusion Criteria:

1. Ability to understand and sign the informed consent
2. Healthy adult men and/or women, 35-65 years old
3. BMI \>18 and \<30 kg/m2

Exclusion Criteria:

1. Volunteer who cannot be expected to comply with the protocol
2. Individuals with self-reported chronic disease; or who have any clinical condition which the investigator deems relevant for exclusion from the study,
3. Individuals with an impaired immune system that may confound immune response testing; i.e. any condition that impairs participant immune response through either the condition itself or through the treatment of the condition,
4. Family or hierarchical relationships with Clinical Innovation Lab at Nestlé Research, Lausanne, Switzerland
Adherence to Colon Cancer Screening (ACCS)

This randomized clinical trial studies website access or genetic counseling with or without patient navigators on adherence to colorectal cancer screening recommendations in patients with newly diagnosed colorectal cancer and their first degree relatives. Websites for colorectal cancer prevention and genetic counseling may be effective methods to help people learn about cancer screening. Patient navigators may improve adherence to colorectal cancer screening recommendations. It is not yet known whether website access or genetic counseling is more effective with or without patient navigators.

PRIMARY OBJECTIVES:

I. Test the comparative-effectiveness of the interventions (i.e., website +/- navigator or genetic counseling +/- navigator) in a randomized controlled trial, using colorectal cancer (CRC) cases as the unit of randomization/analysis on adherence to individualized CRC screening recommendations.

SECONDARY OBJECTIVES:

I. Examine the cost effectiveness of the interventions, assessing the effect of the interventions on subgroups (i.e., Lynch syndrome positive vs. Lynch syndrome negative; probands vs. relatives; older vs. younger patients, etc), and barriers to adherence, as well as how the navigators resolve barriers.

II. Overscreening will be explored.

OUTLINE: Participants are assigned to 1 of 2 study components based on LS status. Within each component, participants are randomized to 1 of 2 arms.

COMPONENT #1 (Lynch Negative Proband and their first degree relatives (FDRs):

ARM I: Participants access a website to deliver a "personalized prescription for CRC prevention" based on age, Lynch Syndrome status, cancer history, age of 1st degree relative with CRC, and personal CRC screening history.

ARM II: Participants access a website as in Arm I and receive the services of a patient navigator to address individual barriers to adhering to the "personal prescription" within 1 month.

COMPONENT #2 (Lynch Positive Proband and their FDRs):

ARM III (Lynch positive proband): Participants use genetic counseling to discuss medical and family history and genetic risk of CRC, including genetic factors such as deoxyribonucleic acid (DNA) mismatch repair genes, autosomal dominant inheritance, cancer risks associated with LS, screening recommendations, and genetic testing.

ARM IV (Lynch positive proband): Participants use genetic counseling as in Arm III and receive the services of a patient navigator to address individual barriers to adhering to the CRC screening recommendations within 1 month.

After completion of study treatment, patients are followed up at 12-14 months.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed with colorectal adenocarcinoma at Ohio State University (OSU) (or a participating Ohio hospital) with sufficient tumor available to perform the microsatellite instability (MSI) test, regardless of age at diagnosis or family history
* First-degree relatives of the cases who test positive for LS
* First-degree relatives of the cases who test negative for LS

Exclusion Criteria:

* Pregnant women
* Prisoners
* Individuals who are cognitively impaired
Neurocognitive and Neurobiological Improvement in ADHD Children by Modification of Dietary Protein

Multicenter, Prospective, randomized, comparative and controlled study about the beneficial effects in behavior and brain connectivity of different dietary patterns in 100 children with ADHD between 7 and 12 years, followed up for 3 months of nutritional therapy.

The investigators collect electroencephalogram (EEG), event related potentials (ERP) data, and behavior parameters in ADD/ADHD children that not take stimulants or other drugs during study. They would only follow some nutritional recommendations based on increasing the amount of dietary protein and fast carbohydrates decrease. The duration of the study will be 6 months, 3 months for recruitment and 3 months for dietary treatment.

Eligibility Criteria:
Inclusion Criteria:

* ADHD diagnosed 12 months before
* no take medication
* BMI above the 25th percentile
* Wiesel score between 80 and 100 (about 120)
* Patients who agree to participate and whose guardians signed the informed consent form

Exclusion Criteria:

* eating disorders
* psychosis, bipolar disorder or depression
* kidney or liver failure
* diabetes
* diuretic or cortisone treatment
* haematological problems
* suprarenal diseases
* cancer
* Brain injury
* Cardiovascular or arrhythmia problems
Longitudinal Study of Covid-19 Infection Among HCW in a French University Hospital

The aim of the study is to determine the incidence o of SARS-cov2 infection among health care workers highly exposed to covid 19 during 10 weeks et to analyze the determinants of their occupational and environmental exposure. Every 14 days, we performed SARS-Cov2 RT- PCR, serological testing and clinical questionnaire among a cohort of 100 HCW with a high degree of exposure to covid19 infection. Information about occupational exposure as the workplace, the activity of care, the characteristics of patient infected are captured, as well as environmental or personal exposure.

The results will support the design of a new care organization and will define new ways of protection for patients (covid or not covid 19) and prevention for HCW.


Eligibility Criteria:
Inclusion Criteria:

- Health Care workers with covid high exposure during the care activities

Exclusion Criteria:

* Heath Care Worker with SARS-Cov2 infection ( RT-PCR +) or SARS-Cov2 immunity in serological testing
* HCW off work
* Subjects on leave
Etiology of Diarrhea in Guinea-Bissau and in Finland

Diarrhoea is the leading cause of death in the world with 2.2 million deaths every year. The majority of deaths are among children in developing countries, but the travellers encounter the disease as well. The studies on the aetiology have suffered from serious methodological deficiencies and the results are even controversial. At the same time, the current diagnostic methods are inadequate. The investigators have recently developed novel multiplex RT-PCR methods to cover the majority of diarrhoeal pathogens. The present study is a collaboration between Finland and Sweden/Guinea-Bissau. The aim is to characterize the causative agents of diarrhoea (a) in Finnish volunteers before and after a travel to tropical areas and, (b) in inhabitants of endemic areas in Guinea-Bissau. For these purposes stool samples will be collected from volunteers of different age groups and from healthy volunteers as well as those with diarrhea both in Guinea-Bissau and in Finland. In addition to pathogens, other intestinal microbes and antimicrobial resistance will be investigated


Eligibility Criteria:
Inclusion Criteria:

1. Accepting to participate and willing to deliver 2 stool samples.
2. With diarrhea: the first 10 children and 10 adults presenting each month at the health facility Without diarrhea: In Bissau matched controls drawn from the registration system at Bandim Health Project. In Finland controls selected at the health facilities participating.

Exclusion Criteria:

* Not willing or able to deliver the stool samples
Bioequivalence Trial of Alprazolam 0.5 mg Tablets

The objective of this study was to confirm if two formulations of alprazolam (tablets) are bioequivalent.

Test product was Zamoprax® 0.5 mg (GlaxoSmithKline) and reference product Tafil® 0.5 mg (Pharmacia \& Upjohn). One tablet was the single dosage.

The study was prospective, open-label, randomized, crossover, single dose, with 02 treatments, 02 sequences and 02 periods, under fasting conditions.

The population was composed of 28 healthy volunteers, both genders, adults between 18-50 years.

The comparative bioavailability of the two formulations was evaluated based in statistical comparisons of relevant pharmacokinetic parameters, obtained from data of drug concentrations in blood.


Eligibility Criteria:
Inclusion Criteria:

Free will participation according to Mexican regulation, Helsinki Declaration, and Good Clinical Practice.

Healthy, between 18 and 50 years. Body Mass Index between 18 and 27.5 In good health by complete medical history and laboratory tests. Blood pressure 130-90/ 90-60 mm Hg; heart rate 55-100 beat per minute, respiratory rate 14-20 movements per minute.

Laboratory tests +/- 10% of normal interval (blood cytology, blood chemistry 27 elements, Hepatitis B and C antigens, HIV, urinalysis, anti-doping, pregnancy, electrocardiogram) -

Exclusion Criteria:

Alteration of vital signs Not complying with inclusion criteria History of cardiovascular, kidney, hepatic, muscular, metabolic, gastrointestinal (including constipation), neurologic, endocrine, hematopoietic (any kind of anemia), asthma, mental or organic disease. Those suffering from muscular trauma 21 days before the beginning of the study.

Requirement of any kind of medication during the course of the study, except study medication.

History of dyspepsia, gastritis, esophagitis, duodenal or gastric ulcer. Exposure to medications known as inducers or inhibitors of hepatic enzymes or administration of potentially toxic medication in the 30 days before the study beginning.

Administration of any medication in the 14 days or 5 half-lives (whatever longer) previous to the beginning of the study.

Hospitalization for any cause in the seven months before the beginning of the study.

Administration of investigational drugs in the 60 days before the study. Allergy to any antibiotic or non-steroidal anti-inflammatory analgesic. Alcohol ingestion or intake of beverages containing xanthines (coffee, tea, cocoa, chocolate, mate, cola drinks) or ingestion of charcoal grilled food or grapefruit or orange juice in the 72 hours before the hospitalization or tobacco smoking in the 72 hours before the beginning of the study.

Blood donation or loss =\> 450 ml in the 60 days before the beginning of the study.

History of drug or alcohol abuse. Positive pregnancy test or antidoping test Special diet requirement, for instance vegetarian diet. Inability to understand nature, aims, and possible consequences of the study. Evidence of non-cooperative attitude during the study. Breast-feeding. Females on contraceptive hormonal treatment.

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Masitinib in the Treatment of Patients With Primary Progressive or Non-active Secondary Progressive Multiple Sclerosis

To evaluate the efficacy and safety of oral masitinib versus placebo in the treatment of patients with primary progressive or secondary progressive multiple sclerosis without relapse.

Masitinib is a selective tyrosine kinase inhibitor, targeting innate immune cells (mast cells and microglia) that are involved in the pathophysiology of progressive multiple sclerosis (MS). This is a multicenter, double-blind, randomized, placebo-controlled, comparative study of oral masitinib in the treatment of patients with progressive MS who were progressing but not clinically active.

Eligibility Criteria:
Main inclusion criteria include:

* Patients with either primary progressive or secondary progressive multiple sclerosis with onset of symptoms at least five years before baseline and with no relapse diagnosed according to the 2017 revised McDonald's criteria at least two years before screening
* Patients with Expanded Disability Status Scale (EDSS) score between 3.0 to 6.0 (both inclusive) at screening and baseline
* Patients with an EDSS score progression ≥1 point with no improvement during 2 years
* Absence of T1 Gadolinium-enhancing brain lesions as measured by MRI at screening

Main exclusion criteria include:

* Patients suffering from a disease other than MS that would better explain the patient's neurological clinical signs and symptoms and/or MRI lesions observed at screening
* Inability to complete screening MRI (contraindications for MRI) and/or any known allergy or hypersensitivity or any contra-indication to gadolinium macrocyclic
* Patients treated with other disease modifying treatments in the time frames and conditions mentioned under previous treatment wash out period, assessed at baseline
* Patients with lymphocytes \<1.0 × 10\^9/L at screening and at baseline
Study of rhASB in Patients With Mucopolysaccharidosis VI

The purpose of this study is to evaluate the long-term efficacy and safety of rhASB treatment in patients with Mucopolysaccharidosis VI.


Eligibility Criteria:
Inclusion Criteria:

* Patient consent
* Patient must have successfully completed study ASB-03-05, including having received at least 20 of 24 scheduled weekly infusions and having missed no more then two consecutive infusions
* If female of childbearing potential, patient must have a negative pregnancy test

Exclusion Criteria:

* Pregnant or lactating patient
* Patient has received an investigational drug within 30 days prior to study enrollment
* Patient is unwilling or unable to travel to the primary site for periodic assessments
Reading Analysis in Ophthalmologic Patients

Investigation of the reading parameters and fixation behavior in patients with different ocular diseases (age-related macular degeneration, glaucoma, diabetic maculopathy, epiretinal membrane) and healthy subjects. In addition, fixation analysis and retinal sensitivity measurements will be done with a microperimeter in each subject.

Reading is a complex function. It requires a proper retinal image that is received by the brain. There it is analyzed for letter and word recognition and then the semantics is detected. Reading speed slows down when letters are blurred, or do not have enough contrast or luminance or when binocular fusion is hampered. Hence, it is obvious that reading ability is reduced in patients with various ocular diseases. Especially, pathologies effecting the posterior pole (central and paracentral vision) might impair reading parameters significantly.

Recently, the Eyetracker Eyelink 1000 (SR Research Ltd, Canada) became available. It´s application was described previously. Briefly, a high-speed infrared camera detects the position of eye (pupil and corneal reflex) and in turn the direction of gaze 500 times per second. During the calibration process the position can be linked to the position on a screen where, for instance, a text or a fixation target can be projected. Direction of gaze is recorded during the reading process and the gathered data are analyzed.

Fixation ability was assessed using Eyelink 1000 in patients with age-related macular degeneration. It was shown that fixation is related to visual function. The worse eye showed reduced fixation ability which is improved during binocular fixation. This study investigates reading parameters in patients with various ocular diseases.

Eligibility Criteria:
Inclusion Criteria:

* Age 21 and older
* Absence of ocular disease (Group 1)
* Present ocular disease (age-related macular degeneration, glaucoma, diabetic maculopathy, epiretinal membrane/macular hole) as judged by the investigator (Group 2 - 5)
* Maximum of allowed cylinder-power in the spectacles: +1.50D

Exclusion Criteria:

* Ocular pathologies, that may interfere with study measurements, such as corneal scars
* In case of pregnancy (pregnancy test will be taken prior to inclusion into the study in women of reproductive age)
Revitalization of Damaged Skin Due to Chronic Skin Diseases

Chronic skin disease lead to skin damage and disfiguring to the patient skin. Sometimes, achieving normal skin is not possible by the normal traditional treatment, this study is focusing on use of ACE CSD formula which is mixture of natural peptides and herbs. the main aim is to restore the normal skin appearance for the patient and control the episodes of flare.

Psoriasis is a chronic, immune mediated (type 2 and type 17) chronic skin disease. The production of the immune proteins that leads to continuous inflammatory mediated process. The result of chronic inflammation is they hyper keratotic layer of skin which gets attacks of atopic dermatitis leading to symptoms of itching, pruritis and in situ bleeding.

ACE CSD, with the multiple factors that mediates the immune response and control the protein receptors, in addition to the multiple regeneration peptides that are specifically extracted from healthy skin of newly born sheep; in addition to multiple Chinese herbs that contains different anabolic factors was tested to be able to regenerate the damaged skin and locally modulate the immunity reactions so the skin can regenerate fully to replace the damaged skin with normal healthy skin.

Eligibility Criteria:
Inclusion Criteria:

* Chronic skin condition lasts for more than 1 year.
* tried traditional treatment with limited or without effect.
* not on steroids for at least 6 weeks.

Exclusion Criteria:

* patients on steroid.
* patients intolerable to protein or allergic to proteins
* during pregnancy or lactation
Effectiveness of Immobilization in the Postoperative Analgesia of Surgically Treated Distal Radius Fractures

The purpose of this study is to determine wether postoperative immobilization is effective in controlling the pain of patients with intra-articular distal radius fractures treated with volar locking plate fixation. The study hypotheses is that postoperative immobilization does not enhance the analgesia of these patients.

Volar locking plate fixation has been used as the gold standard treatment for intra-articular distal radius fractures. The need for postoperative immobilization after this type of fixation is controversial, with some authors advocating its use for analgesia. Conversely, the use of immobilization might retard the recovery of wrist range of motion and function. The objective of this study is to compare the level of pain and function of patients undergoing surgical fixation of distal radius fractures using or not postoperative immobilization. Patients will be randomly assigned to receive a plaster splint or conventional dressing immediately after the surgery. The main outcome is the level of pain in the first two weeks postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* Intra-articular distal radius fracture treated with volar locking plate fixation;
* Fracture occurred within the prior 30 days;
* Consent to participate in the study

Exclusion Criteria:

* Concomitant fracture of the ipsilateral upper limb
* Previous lesion of the ipsilateral upper limb with functional deficit
* Bilateral fracture
* Concomitant neurologic injury
* Patient not amenable to follow-up