cyrilzakka/clinical-trials huggingface dataset:
Safety and Effectiveness of Collagen Cross Linking in Progressive Mild and Moderate Keratoconus

The purpose of this study is to evaluate the effectiveness of collagen cross linking (CXL) in reducing progression of mild and moderate progressive keratoconus.

Keratoconus is a corneal degeneration characterized by bilateral conical protusion and corneal thinning. The course of the disease varies from slight irregular astigmatism to severe visual impairment due to increasing protrusion and subepithelial scarring. There is no treatment available that can stop keratoconus progression. Thus, because of its progressive nature, keratoconus is the most frequent reason for keratoplasty worldwide in the past 3 decades.

The collagen crosslinking (CXL) technique using riboflavin and ultraviolet - A (UVA) light was recently developed to counteract the progressive corneal thinning, and thus the progression of keratoconus. With crosslinking, additional covalent binding between collagen molecules can be achieved, which stabilizes the collagen scaffold and enhances corneal resistance.

Prospective longitudinal randomized case-control study including progressive keratoconus cases is addressed to evaluate the effectiveness of collagen cross linking (CXL) in reducing progression of mild and moderate progressive keratoconus. Progression is based on increase in the cone apex keratometry of - 0,75 D, alteration of - 0,75 D in the spherical equivalent or increase of the anterior chamber depth on Pentacan, in a period of at least six months. All patients must be between 15 and 40 year old and are randomized and allocated in the treated or the control groups. Complete exam before and after exam included best corrected visual acuity, refraction, IOP, fundoscopy, imaging exams such as corneal computerized topographic, pentacan, orbscan, ultrasound pachymetry, esthesiometry, endothelial cell count, HRT II system confocal microscopy, optic coherence tomography (VISANTE), ORA , optic coherence tomography (Stratus OCT) and dynamic contour tonometry . All the exams are repeated 1, 3, 6 and 12 months after the procedure. The cross linking is performed as follows: after topical anesthesia, the epithelial tissue is removed in a 8.0mm diameter area of the central cornea, the 0,1% riboflavin solution is applied every 2 min, for 30 min followed by cornea irradiation with UVA light with a wavelength of 370 nm and an irradiance of 3 mW/cm2. During the irradiation, drops of the riboflavin solution is continuously applied onto the cornea every 5 min.

Eligibility Criteria:
Inclusion Criteria:

* Keratoconus patients, with progression of the disease, based on an increase in the cone apex keratometry of - 0,75 D, alteration of - 0,75 D in the spherical equivalent or increase of the anterior chamber depth on pentacan, in a period of at least six months.

Exclusion Criteria:

* pregnancy, corneal thickness less than 400 μm, history of corneal surgery, herpes ocular infection, other corneal disease or scarring, chemical injuries and riboflavin allergy
Study of a Suprachoroidal Retinal Prosthesis

This study is a proof of principal, to evaluate a safety and efficacy of a prototype suprachoroidal retinal implant.

Retinal visual prostheses are currently in early development as an intervention to improve functional vision in people who have become blind from retinal degenerative eye disease. This study follows on from an initial proof of concept study (n=3) between 2012 and 2014, and will test a second-generation retinal prosthesis device, which has the ability to be used outside of the laboratory environment (i.e. is fully implantable).

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older
* Either gender
* A confirmed history of outer retinal degenerative disease such as retinitis pigmentosa or choroideremia
* Remaining visual acuity of bare light perception or less in both eyes
* Functional inner retina (ganglion cells and optic nerve), as shown by the ability to perceive light and/or a measurable corneal electrically evoked visual response
* A history of at least 10 years of useful form vision in the worse seeing eye

Exclusion Criteria:

* Optic nerve disease (history of glaucoma of More than 1 month, or history of any other optic neuropathy)
* Diseases of the inner retina including, but not limited to, central retinal artery or vein occlusion (CRAO, CRVO), end stage diabetic retinopathy, retinal detachment, traumatic retinal damage, infectious retinal disease, inflammatory retinal disease.
* Inability to visualise the retina due to corneal or other ocular media opacities (corneal degenerations, dense cataracts, trauma, lid malpositions)
* Any ocular condition that predisposes the participant to rubbing their eyes
* Cognitive deficiencies, including dementia or progressive neurological disease
* Psychiatric disorders, including depression, as diagnosed by a qualified psychologist
* Deafness or significant hearing loss
* Inability to speak or understand English
* Pregnancy
* Presence of a cochlear implant
* Participant enrolled in another investigational drug or device trial for the treatment of their ocular condition
* Poor general health, which would exclude them from obtaining a general anaesthetic
* Unrealistic expectations of the investigational device to provide functional vision
* Poorly controlled diabetes
* Epilepsy
* Unsuitable level of regular nystagmus (which would prevent ocular images from being obtained)
* Anyone with medical devices (implanted or carried) that could cause serious health problems if compromised by electro-magnetic interference
Shark Cartilage in Treating Patients With Advanced Colorectal or Breast Cancer

RATIONALE: Shark cartilage extract may help shrink or slow the growth of colorectal cancer or breast cancer cells.

PURPOSE: Randomized phase III trial to determine the effectiveness of shark cartilage in treating patients who have advanced colorectal cancer or advanced breast cancer.

OBJECTIVES:

* Determine whether the addition of powdered shark cartilage (BeneFin™) to standard therapy improves overall survival in patients with advanced colorectal or breast cancer.
* Determine whether this therapy has any impact on toxicity in these patients.
* Determine whether this therapy improves the quality of life in these patients.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to disease type (breast vs colorectal female vs colorectal male), age (49 and under vs 50-69 vs 70 and over), ECOG performance status (0-1 vs 2), baseline quality of life (UNISCALE rating less than 50% vs 50-75% vs more than 75%), and concurrent chemotherapy (yes vs no). Patients are randomized to 1 of 2 treatment arms.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Breast or colorectal primary tumor sites

  * Considered incurable
* Breast cancer patients must have disease progression after at least 2 different chemotherapy regimens (may include chemotherapy given as an adjuvant treatment)

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Sex:

* Male or female

Performance status:

* ECOG 0-2

Life expectancy:

* More than 3 months

Hepatic:

* Bilirubin no greater than 3 times upper limit of normal (ULN)

Renal:

* Calcium less than 1.2 times ULN

Other:

* Not pregnant or nursing
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Chemotherapy:

* Concurrent chemotherapy allowed
* No concurrent participation in a cytotoxic chemotherapy clinical trial

Other:

* At least 60 days since prior shark cartilage
Magnesium Treatment of Inflammation in Disorders of Glucose Homeostasis

In most diabetic patients where low blood magnesium levels occur the important depletion of cellular levels is usually not measured. This study will measure both blood and oral mucosal cell magnesium levels before and after 3 months of supplementation with magnesium tablets (the recommended dietary amount of 336 milligrams per day). These magnesium levels will be correlated with blood levels of indicators of inflammation (eg C reactive protein) to see whether the cellular levels are more reliable than blood levels of magnesium for appropriate treatment of magnesium deficiency in diabetic patients.

The anti-inflammatory effects of oral magnesium (Mg) supplementation of diabetic and metabolic syndrome patients with low serum Mg levels have been studied with increased interest in recent years. However, serum magnesium levels only represent less than one percent of total body magnesium; whereas cellular deficiency of Mg is a more reliable parameter to assess repletion of this essential mineral for correlation with indices of inflammation.

The proposed research will compare the efficacy of a 3 month period of treatment with oral Mg of diabetic patients selected for elevations of CRP, TNFα and other markers of inflammation on cellular and serum levels of Mg.

We anticipate that 50 hypomagnesemic diabetic patients will be selected for 3 months of supplementation with 336 mg of Mg lactate tablets. The repletion of serum and oral epithelial cell Mg levels will be correlated with responses of CRP, TNFα, substance P, HgbAIc and oxidative/nitrosative (ROS/RNS) stress parameters before and after treatment. Individuals will be selected from the Dasman Diabetes Institute in Kuwait. With completion of these analyses, a collaborative manuscript with joint authorship will be prepared and submitted for publication.

Eligibility Criteria:
Inclusion Criteria:

* Have documented hypomagnesemia (serum levels ≤ 1.8 mg/dL or 0.74mmol/L);
* Be between 20-70 years of age at the time of randomization
* Have hyperglycemia due to NIDDM metabolic syndrome or obesity
* Have at least one abnormal indicator of inflammation (e.g. elevated CRP, TNF-α)
* Have no active infection

Exclusion Criteria:

* Currently have significant gastrointestinal disorders (e.g. chronic diarrhea);
* Have impaired renal function, defined as eGFR \< 60 mL/min/1.73m2 or serum creatinine \> 1.3 mg/dL;
* Are current being treated for hypertension (e.g. ACE inhibitors and diuretics), heart block (e.g. EKG evidence of left bundle branch block) or heart failure (e.g. treated with aldosterone antagonists);
* Are currently pregnant;
* Have chronic inflammatory disorders (e.g. psoriasis);
* Have used of Mg supplements and Mg-rich mineral water within 6 months;
Gold Factor on Knee Joint Health and Function

The purpose of this clinical study was to determine whether gold nanoparticles (AuNP) supplement holds clinical value in improving joint health, function, and quality of life for arthritis patients.

The purpose of this clinical study was to determine whether gold nanoparticles (AuNP) supplement holds clinical value in improving knee joint health, function, and quality of life for arthritis patients. A total of 51 participants were followed for 20 weeks through a three phase longitudinal study. Both subjective and objective parameters were used to measure and monitor changes in knee joint health and function, as well as quality of life.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 and \<87 years of age
* Having arthritis
* Suffering from chronic knee pain
* Failed treatments to date - including surgery, Physical Therapy, NSAIDs
* Must agree to maintain the same eating, exercise, and sleep arrangements for the whole duration of the study

Exclusion Criteria:

* Having bacterial, intra-articular, or knee infections
* Had any knee related partial or complete total knee replacement within 3 months prior to the start of the study
* Had recent (3 months prior to start of the study) knee injection
* Currently on NSAIDs
* currently pregnant or lactating
Efficacy of Ciclesonide Inhaled Once Daily Versus Other Corticosteroids Used for Treatment of Mild Asthma in Children (4 to 11 Years) (BY9010/CA-101)

The aim of this study is to compare the efficacy of ciclesonide with respect to reduction of the number of asthma exacerbations in children with mild persistent asthma. Treatment medication will be administered as follows: ciclesonide will be inhaled once daily, using one of the two dose levels versus placebo together with other corticosteroids used as intermittent treatment. The study duration consists of a baseline period (3 to 4 weeks) and a treatment period (12 months). The study will provide further data on safety and tolerability of ciclesonide.

The drug being tested in this study is called ciclesonide. Ciclesonide is being tested to treat children who have mild asthma.

The study enrolled 240 patients. Participants were randomly assigned (by chance, like flipping a coin) to one of the three treatment groups-which remained undisclosed to the patient and study doctor during the study (unless there was an urgent medical need):

* Ciclesonide 100 µg
* Ciclesonide 200 µg
* Placebo (dummy inactive inhalation) - this is a metered-dose inhaler that looks like the study drug but has no active ingredient.

All participants were asked to take two puffs from a metered-dose inhaler once daily, in the evening, for up to 12 months.

This multi-center trial was conducted in Canada, Hungary and South Africa. The overall time to participate in this study was 12 months preceded by a baseline washout period of 3 to 4 weeks. Participants made multiple visits to the clinic including a safety follow-up visit within 30 days of the last treatment.

Eligibility Criteria:
Main Inclusion Criteria:

* Outpatients
* Symptoms consistent with the diagnosis of asthma for at least 12 months
* Forced Expiratory Volume in one Second (FEV) at least 80% of predicted
* Participants who have a history of reversible airway obstruction
* Good health with the exception of asthma

Main Exclusion Criteria:

* History of life-threatening asthma
* A hospitalization for asthma within the last 3 months, or more than two hospitalizations for asthma within the last year
* Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids
* Participants suffering from relevant lung diseases causing alternating impairment in lung function (e.g. chronic bronchitis or emphysema)
* Prematurely born children (\<36 weeks of gestation)
* Smokers
* Pregnancy (or intention to become pregnant during the course of the trial), breast feeding or lack of safe contraception by female of child-bearing potential
The Sputum Colour Chart as a Predictor of Lung Inflammation and Proteolysis in Non-cystic Fibrosis Bronchiectasis

Non-cystic fibrosis bronchiectasis patients (and controls) were recruited for the study. The investigators' aim was to study the relevance of clinical parameters in terms of underlying disease severity, proteolysis and inflammation in a diverse non-cystic fibrosis bronchiectasis population.

Patients from the non-cystic fibrosis bronchiectasis (NCFB) outpatient clinic were recruited in our study from September 2009 till July 2010. Control healthy subjects were recruited among peers of the patient or hospital staff during the same period. For the NCFB patients, underlying etiologies of NCFB and Pseudomonas aeruginosa (PA) colonization status were analyzed and each patient was evaluated by means of spirometry (FVC and FEV1), Leicester Cough Questionnaire (LCQ) and Sputum Colour Chart (SCC). SCC assessment was both done by letting the patient predict his sputum purulence prior to sputum induction and by SCC scoring after sputum harvest by the physician.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of NCFB, based on CT findings of bronchiectatic disease in the absence of cystic fibrosis (CF) as a cause.
* stable

Exclusion Criteria:

* no recent exacerbation
Combating Hospital-related Function Decline Among Prefrail Older Adults: A Pilot Study

This study focuses on the "Strength-based Tailored-Exercise Program at Home (STEP@Home)" aimed at improving health outcomes for geriatric patients at risk of hospitalization-associated functional decline. It is a sequential mixed-method study that combines quantitative and qualitative approaches.

The research is a pilot study to develop the STEP@Home intervention, integrating a strength-based, tailored exercise regimen for elderly patients post-hospital discharge. It addresses hospitalization-associated functional decline (HAFD) by engaging patients in sustainable self-practice of physical exercises at home. The study employs empowerment strategies, lifestyle-integrated functional exercises, and optimized tele-platform use to maximize therapeutic benefits. By focusing on empowering patients through sustainable self-practice of physical exercises at home, it aims to enhance physical functions and improve health-related quality of life. The study also has significant real-world implications, potentially offering a scalable, effective solution for the broader geriatric population to manage HAFD, thereby reducing healthcare costs and improving overall well-being. The research intends to assess the program's impact on physical functions and health-related quality of life, utilizing a sequential mixed-method approach for a comprehensive evaluation.

Eligibility Criteria:
Inclusion Criteria:

* i) aged 60 or above, ii) prefrail as defined by a score of 1-2 on the Frail Scale (FS) which measures fatigue, resistance, ambulation, illness and weight loss over the last 4 weeks, iii) discharged home without any community care referral, iv) cognitively capable to receive exercise training as indicated by an Abbreviated Mental Test score of ≥ 6, and v) consented to participate

Exclusion Criteria:

* (i) engaging in moderate or vigorous exercise (\>60min/week) in the past 6 months, and (ii) with conditions contradictory to exercise training (e.g., acute muscular-skeletal problem, acute and unstable cardio-respiratory disease, etc).
Navigated EBUS and Functional Imaging in Lung Cancer

Electromagnetic navigation systems have proved feasible for precise intraoperative guiding during videobronchoscopy and endobronchial ultrasound transbronchial needle aspiration (EBUS-TBNA), based on maps made of preoperative CT images. PET--CT, PET--MRI and fMRI can point out malignant lesions.

When fused into a research navigation system, functional imaging can add information of optimal sampling points in lung cancer staging. Correct image registration is then fundamental. This study is a build--on to NCT02493023, assessing the position and image registration accuracy and clinical feasibility of a multimodal image guiding system in patients referred for lung cancer staging by EBUS--TBNA.

A research navigation platform displays the intraoperative position of the endoscope inside the airways, and shows its position in 3D maps made from the patients' own preoperative images (PET-- CT, PET--MRI or fMRI). Images are acquired ahead of study inclusion. The navigation system acquires position data, first from a videobronchoscope, then from an EBUS--scope (same sort of output data acquired from both endoscopes) equipped with a position sensor for electromagnetic tracking.

From intraoperative position data, the accuracy of the image--to--patient registration (for CT, PET--CT, PET--MRI and fMRI) and the navigation system accuracy are calculated.

Electromagnetic navigation fused with available image modalities can be used to navigate directly and precisely to the area with highest suspicion of malignancy. Multimodal image guiding systems with functional imaging may thereby lead to improvements in endoscopic lung cancer staging, f. i. in diagnostic yield, procedure time and safety.

Eligibility Criteria:
Inclusion Criteria:

* referred to thoracic department St Olavs Hospital due to suspicion of lung cancer
* informed consent

Exclusion Criteria:

* pregnancy
Touching the World With a Cane: Cognitive and Neural Processes

The use of tools is ubiquitous in our lives and allows us to expand the sensorimotor capacities of our body. Much research has been done on the subject in sighted people over the past decades. This work has mainly focused on the motor aspect of using the tool, neglecting the sensory aspect. However, any action involving a tool carries sensory information, for example in the use of the white cane by blind people. 26% (\> 200,000) of blind people in France use a white cane to get around. By sweeping the cane on the ground, they use it as a sensorimotor extension of their body to extract information from the environment in order to locate a pedestrian crossing or possible obstacles. While it is well established that the tools increase the user's motor skills, we have only just begun to clarify how they also function as sensory extensions of the user's body and how this phenomenon is potentially dependent on constant use of the tool to compensate for a missing sense, as is the case with blind people using a cane. The aim of this study is to fill this important gap in our knowledge.


Eligibility Criteria:
Inclusion Criteria:

* Man or woman, aged 18 to 60 years old
* Give an informed consent by signature
* Be part of the national health security system (registered to the Securité Sociale)
* do not confuse his right and his left

Specific of the non-sighted participants:

* Loss of vision happened at birth or 3-to 5 years later in life
* Must have a visual acuity inferior or equal to 4/10
* Be with a close relation for read information letter and sign the consent form if needed

Exclusion Criteria:

* A person presenting an history of neurological, psychiatric or linguistic problems cannot be admitted
* Assumption of psychotropic drugs
* Pregnancy or breast-feeding woman
* A person under legal tutoring
* A person under care in other medical structure for reasons different from those of this research
* A person under administrative or judiciary contention
* A person who is not eligible to a MRI-exam according to the following criteria cannot be admitted to the experiments including MR acquisitions :

  * Have a neurological, cardiac (battery) or defibrillator pacemaker
  * Have a cardiac prosthesis (valve, stent...) or vascular prosthesis
  * Have intracranial clips or clamps
  * Carry a bypass of the cerebrospinal fluid
  * Having metallic splinters in the eyes
  * Wear metal prostheses (teeth, knees)
  * Wear an infusion pump or system
  * Be claustrophobic or have respiratory problems
  * Have metal tattoos close to the head
  * Have permanent make-up
Study to Evaluate HL-TOF Tab. 5 mg Compared With XelJanz Tab. in Healthy Volunteers

To evaluate the safety and pharmacokinetics of HL-TOF tab. 5 mg compared with those of XelJanz tab. in healthy volunteers

The purpose of this study is to evaluate the safety and pharmacokinetics of tofacitinib after single oral administration of Xeljanz tab. 5mg as reference drug and HL-TOF tab. 5mg as test drug in healthy voluteers. AUC and Cmax would be evaluated for the pharmacokinetics. Adverse event, Laboratory examination and other examination result would be evaluated for the safety.

Eligibility Criteria:
Inclusion Criteria:

* Years 19-60
* No pathological symptoms or findings
* Suitable for the criteria for examination
* 90≤SBP≤139, 60≤DBP≤89
* Body weight≥50kg (Female≥45kg) and 18≤BMI≤30kg/m2
* Contraceptive during the study period
* Volunteer for the study and sign to ICF

Exclusion Criteria:

* Subject with medical history which affect on the absorption of drug
* Following condition: Mental illness, Hepatic disorder, Tuberculosis, ANC\< 500cells/mm3, ALC\<500cells/mm3, Hb\<8g/dL
* Subject with hypersensitivity reaction to HL-TOF and Xeljanz
* Subject with galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
* Subject who take a vaccination within 30 days
* Subject who take a medication such as barbiturates within 30 days
* Subject who take a medication that affect to the pharmacokinetics of drug within 10 days
* Subject who take alcohol more than 21 cups per week
* Subject who smoke 20 cigarettes per day
* Subject who participate in any clinical investigation within 6 month prior to study medication dosing
* Subject with whole blood donation within 60 days, component blood donation within 14 days, blood donation within 30 days
* Subject with decision of non-participation through investigator's review