cyrilzakka/clinical-trials huggingface dataset:
Performance of Toric Hydrogel Lenses Following A Refit With Toric Silicone Hydrogel Lenses for 1 Month

The aim of this prospective study is to evaluate the clinical performance of habitual wearers of methafilcon A toric lenses after a refit with fanfilcon A toric lenses for 1-month of daily wear.


Eligibility Criteria:
Inclusion Criteria:

* Is between 18 and 40 years of age (inclusive)
* Has had a self-reported visual exam in the last two years
* Is an adapted soft contact lens wearer
* Has a contact lens spherical prescription between +6.00 to - 8.00 (inclusive)-Have no less than -0.75D of astigmatism and no more than -2.25 D in both eyes
* Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye.
* Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses.
* Has clear corneas and no active ocular disease
* Has read, understood and signed the information consent letter
* Patient contact lens refraction should fit within the available parameters of the study lenses
* Is willing to comply with the wear schedule (at least 5 days per week, \>8 hours/day assuming there are no contraindications for doing so)
* Is willing to comply with the visit schedule

Exclusion Criteria:

* Has a Contact Lens (CL) prescription outside the range of the available parameters of the study lenses
* Has a spectacle cylinder less than -0.75D or more than -2.50 D of cylinder in either eye
* Has a history of not achieving comfortable Contact Lens (CL) wear (5 days per week; \> 8 hours/day)
* Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye
* Presence of clinically significant (grade 2-4) anterior segment abnormalities
* Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear
* Slit lamp findings that would contraindicate contact lens wear such as:

  * Pathological dry eye or associated findings
  * Pterygium, pinguecula, or corneal scars within the visual axis
  * Neovascularization \> 0.75 mm in from of the limbus
  * Giant papillary conjunctivitis (GCP) worse than grade 1
  * Anterior uveitis or iritis (past or present)
  * Seborrheic eczema, Seborrheic conjunctivitis
  * History of corneal ulcers or fungal infections
  * Poor personal hygiene
* Has a known history of corneal hypoesthesia (reduced corneal sensitivity)
* Has aphakia, keratoconus or a highly irregular cornea
* Has Presbyopia or has dependence on spectacles for near work over the contact lenses
* Has undergone corneal refractive surgery
* Is participating in any other type of eye related clinical or research study.
Bioequivalence Study For Orally-Disintegrating Tablet Of Sildenafil

The purpose of this study is to assess the bioequivalence of Sildenafil ODT 50 mg without water to Japanese commercial oral tablet of sildenafil citrate (Viagra® tablet) 50 mg under fasted conditions.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Japanese male subjects between the ages of 20 and 55 years.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* Baseline orthostatic hypotension defined as a \>=20 mm Hg reduction in systolic blood pressure (SBP), a \>=10 mm Hg reduction in diastolic blood pressure (DBP) or the development of significant postural symptoms (dizziness, lightheadedness, vertigo) when going from the supine to standing position.
* Subjects who are currently prescribed or taking nitrates or nitric oxide donors in any form on either a regular or intermittent basis.
Clesrovimab (MK-1654) in Infants and Children at Increased Risk for Severe Respiratory Syncytial Virus (RSV) Disease (MK-1654-007)

This study aims to evaluate the safety and tolerability of clesrovimab compared to palivizumab as assessed by the proportion of participants experiencing adverse events (AEs).


Eligibility Criteria:
Inclusion Criteria:

* Participants at increased risk for severe RSV infection recommended to receive palivizumab in accordance with national or local guidelines or professional society recommendations.
* Is available to complete the follow-up period.

Exclusion Criteria:

* Requires mechanical ventilation at time of enrollment.
* Has a life expectancy \<6 months.
* Has known hepatic or renal dysfunction, or chronic seizure disorder.
* Is hospitalized at the time of randomization unless discharge is expected within 7 days after randomization.
* Has severe immunodeficiency or is severely immunocompromised.
* Has known hypersensitivity to any component of clesrovimab or palivizumab.
Transcranial Magnetic Stimulation Study of Cortical Excitability as Marker of Antidepressant Response: EXCIPSY Study

Depression is a common issue but there is no marker of response to an antidepressant treatment.The measurement of variation of the cortical excitability in responders to a selective serotonin reuptake inhibitor (SSRI) (compared to no-responders) had never been done before. In the study of Robol et al. (2004) concerning the acute effects of citalopram on markers of cortical excitability, the authors have pointed out an increase on the cortical silent period (CSP) after administration of citalopram (2.5 hours). The investigators hypothesize that this effect remains later and that the diminution of cortical excitability could be a biomarker of antidepressant response. In this case, they expect that the variation of CSP between day 1 and day 28 is higher in responders to a SSRI (citalopram) compared to non-responders. the investigators lead a pilot, prospective, multicentric study in drug-naive patients to compare the variation of the markers of cortical excitability (the CSP but to the resting motor threshold RMT, the motor evoked potential MEP, the intra-cortical inhibition ICI and the intra-cortical facilitation ICF) between day 1 and day 28 in responders to citalopram, compared to non-responders.


Eligibility Criteria:
Inclusion criteria:

* major depressive episode (according to DSM 5 criteria). Severity of depressive episode assessed by Hamilton Depressive Rating Scale 21 items (HAMD-21) : score \> 15 (significant impairment), low suicide risk (score \< 2 on suicide item).
* Drug-naive patient (or antidepressant stopped for more than 3 months).
* Patient covered by security social system.
* Patient who is able to read and understand the information paper. Patient who is able to sign the consent.
* For women of childbearing age, effective method of contraception (estrogen-progestin contraceptive or intra-uterine device or tubal ligation) for more than 1 month (negative pregnancy test).

Exclusion criteria:

* Coprescription of psychoactive or neurological drugs known to alter cortical excitability
* Other psychiatric disorders (psychotic disorders, eating disorders).
* Change of antidepressive drug during the study.
* Abuse or addiction at other substances than nicotine or caffeine.
* Unsteady consumption of nicotine or caffeine.
* Dermatologic disease, dementia, medical history of seizure or epilepsy, brain tumor, metallic biomedical implants in brain.
* Ongoing treatment by magnetic or electric stimulation (for example : transcutaneous nerve stimulation or spinal cord stimulation).
* Women of childbearing age without effective contraception, pregnant or breastfeeding.
* Patient who was already included in a clinical trial within 30 days before the inclusion visit.
* Patient deprived of liberty and under guardianship.
The Effects on Physical Activity on Mitochondrial Function in Skin Fibroblasts in Patients with Parkinson's Disease.

The aim of this study is to investigate the effect of physical activity on mitochondrial function in skin fibroblasts in patients with Parkinson's disease.

A randomized double-blind clinical trial will be conducted to study the effects of physical activity on mitochondrial function in skin fibroblasts in patients with Parkinson's disease. It is an intervention study, and twenty-four patients will be needed. Once the subjects have been selected, they will be randomly assigned into three groups (eight patients in each group). The first group will perform basic physical training (BPT) based on strength and resistance, the second group will perform BPT combined with functional exercises (BPTFE) with cognitive and motor training, and the third group will not carry out any activity program, serving as control. The interventions will last 60 minutes, with a frequency of 3 times a week, during 16 weeks. The control group will receive 4 months of PA from the program that has obtained the best results,in terms of symptoms and quality of life, after the last evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a medical diagnosis of idiopathic PD, Hoehn and Yahr scale stages of I-III.
* Patients who score ≥26 on the Montreal Cognitive Assessment (MoCA).
* Patients who have signed the IC.
* Patients with stable medication.
* Age between 50 and 70 years, and able to walk independently for 6 minutes.

Exclusion Criteria:

* Patients with a pathology other than idiopathic PD.
* Patients with cognitive impairment (MoCA \<26 points).
* Patients with uncontrolled cardiovascular disease, visual impairment, or recent musculoskeletal disorders in the extremities.
* Patients who are performing another therapeutic exercise protocol.
* Patients who have undergone surgery to influence any symptom from the PD.
Amitriptyline and Paroxetine Treatment of Major Depression

Activation of the hypothalamus-pituitary-adrenal system is monitored using saliva cortisol sampling during the antidepressant treatment with amitriptyline and paroxetine in moderately to severely depressed patients. Additionally, serum and plasma are sampled during the 5-week study period in order to study endocrine and metabolic parameters.


Eligibility Criteria:
Inclusion Criteria:

* age: above 18
* depression according DSM-IV

Exclusion Criteria:

* bipolar disorder
* substance dependency
Study Using Genomic, Histologic and Radiomic Analysis to Evaluate Regional Tumor Heterogeneity in Patients Undergoing Surgery for Newly Diagnosed Glioblastoma

Glioblastomas (GBM) demonstrate in vivo genetic and histologic heterogeneity that can be non-invasively identified using imaging phenotypes that identify regionally distinct areas of tumor with genetic alterations that drive tumor resistance pathways. The researchers propose a unique approach to assess initial GBM heterogeneity by performing histological and genomic analysis of biopsies targeted by advanced MRI before treatment.


Eligibility Criteria:
Inclusion Criteria:

* Suspected newly diagnosed or recurrent supratentorial glioblastoma eligible for surgical biopsy and/or resection
* Patients must be 18 years of age or older
* Study-specific informed consent approved for this purpose by the IRB of the University of Michigan

Exclusion Criteria:

* Patients unable to undergo MRI
Noncontact, Handheld Device for Measurement of Respiratory Rate

In the emergency department, a sick child is usually seen first by a nurse. Their job is to quickly assess how sick the child is and what immediate care is needed. The nurse will usually use electronic devices to check vital signs, such as body temperature, pulse rate and blood oxygen levels. However, the nurse normally has to manually count the respiration rate (this is the number of breaths taken each minute) because there is no suitable device which can do this automatically. Knowing the respiration rate is very important because if it is not normal, the nurse knows that the child may be seriously ill. Counting the respiration rate of sick children can be difficult and takes up a lot of time, especially if the child is upset, crying or moving about. To overcome this problem we are developing a device that automatically measures respiration rate in children. It works by directly sensing the air coming from the nose or the mouth when held at a small distance (about 30 cm) from the face. So far, the device has been shown to work in a research laboratory at Sheffield Hallam University. The aim is to develop it into a handheld, userfriendly device, ensuring that it complies with strict safety regulations. This application is to carry out an evaluation of our new device against its gold standard, on adult volunteers and on children attending Sheffield Children's Hospital for sleep studies as part of their clinical care. In the future, when nurses use the device they will easily be able to measure each child's respiration rate so that the most seriously ill children will be identified earlier and get correct treatment more quickly. This will ensure that the right children get admitted to intensive care units sooner and, in some cases, child deaths will be prevented.


Eligibility Criteria:
Inclusion Criteria:

* any person requiring and able to perform a respiratory rate measurement

Exclusion Criteria:

* people assessed as too unwell to participate by clinical team
* people for whom English is not first language as no interpreting service included in budget
Health in Motion Pragmatic Clinical Trial - WRAPAROUND

Falls among older adults are a serious public health concern, and injuries resulting from falls can cause significant loss of independence, premature death, and higher caregiver burden. Home-based fall prevention programs, such as the Otago Exercise Program, educate older adults about the importance of identifying fall risk and provide strategies for reducing fall risk; however, many are costly and are not scalable, accessible, or sustainable. This project will compare a digital fall prevention program used in a group setting in the community with traditional community-based fall prevention programs.

This study will involve 2 groups. Group 1 will participate in traditional human-led community based fall prevention programs and Group 2 will participate in avatar-led community-based fall prevention program. Metrics of effectiveness include the rate of falls, fall risk, fear of falling, and falls efficacy. Economic benefit will be measured using the European Quality of Life 5-Dimensional Questionnaire, along with hospital and clinical visits. The primary outcome is the incidence of falls (rate in person-months).

Eligibility Criteria:
Inclusion Criteria:

* age of 55 and older
* Score \>30 on the TICS (Telephone Interview for Cognitive Screen) or if lower than 30 has assistance to participate

Exclusion Criteria:

* any person who has been told by their physician that they should not exercise
Unconventional Financial Incentives for Smoking Cessation

The proposed study is a randomized study of actively smoking veterans cared for at the Miami VA Medical Center. Subjects are randomized into 2 groups and will all receive a regimen of nicotine replacement therapy (NRT) standardized to their smoking habit. Subjects are followed biweekly for smoking cessation by using biochemical tests (exCO and COHb) to determine smoking abstinence. The first group called the Banked-Money Group will have $50 placed in a 'bank account' for every clinic visit where their tests reveal abstinence from smoking. As a modified commitment contract, the Banked-Money Group can only withdraw the accrued money at the end of the trial if they complete the trial by quitting smoking for the entire 6 months. The second group called the Reward Group will directly receive $50 for every clinic visit where their tests reveal abstinence from smoking.


Eligibility Criteria:
Inclusion Criteria:

Enrollment criteria include subjects 18 years of age or older, currently smoking at least a half a pack of cigarettes a day, who have at least a ten-pack year smoking history, are interested in quitting smoking, agree to submit to exhaled breath and ABG analysis and have reliable means of visiting the clinic every two weeks. Subjects must be able to tolerate NRT including patches and lozenges and meet with the VA smoking cessation counselor.

Exclusion Criteria:

Subjects will not be enrolled if they are currently taking varenicline as the VA disallows concurrent use of varenicline and NRT.
In Vivo Patient Preoperative Skin Prep Persistence

The objective of the study is to demonstrate persistence of the CHG/IPA Prep on skin flora of the abdominal and inguinal regions of human subjects.

The objective of the study is to demonstrate persistence of the CHG/IPA Prep versus a saline placebo on skin flora of the abdominal and inguinal regions of human subjects as measured by change in microbial flora relative to baseline.

Eligibility Criteria:
Inclusion Criteria:

* Subjects of any race
* Subjects in good general health
* Minimum skin flora baseline requirements on abdomen and groin

Exclusion Criteria:

* Any tattoos, scars, breaks in the skin, or any form of dermatitis, or other skin disorders (including acne) on the applicable test areas
* Topical antimicrobial exposure within 14 days prior to screening and treatment days
* Use of systemic or topical antibiotics, steroid medications, or any other products known to affect the normal microbial flora of the skin within 14 days prior to screening and treatment days
Training of Psychosocial Skills Based on Cognitive Behavioural Therapy for Patients With Parkinson's Disease

Patients with Parkinson's disease (PD) will be trained using a cognitive behavioral group-training-program to reduce stress and augment quality of life. An unspecific group with the same amount and frequency of meetings is used as a control group. For the evaluation of the training effects, scales to assess quality of life, analyses of psychopathological variations as well as neurocognitive tests will be used. Protocol amendment in 1-2017: addition of FU year 3 and year 5.


Eligibility Criteria:
Inclusion Criteria:

* Patients with idiopathic Parkinson's disease according to United Kingdom Parkinson's Disease Brain Bank Criteria, being either cognitively normal, suffering from Mild Cognitive Impairment or having mild dementia. Patients must be able to give their written informed consent.

Exclusion Criteria:

* Moderate or severe dementia (DMS-IV, Mini Mental Status (MMS) \<24), other neurological or psychiatric diseases of the brain not related to PD, secondary parkinsonism, physical impairment hindering the adequate execution of the training, insufficient knowledge of German or pregnancy are exclusion criteria. Deep Brain Stimulation (DBS) is no exclusion criterion.
An Observational Study of Gonal-F Filled by Mass Pens in Multifollicular Stimulation Prior to In-vitro Fertilization (IVF) or Intracytoplasmic Sperm Injection (ICSI)

This is a prospective, observational study in women using Gonal-F filled-by-mass (FbM) in ovarian hyperstimulation as part of their in-vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) treatment at infertility clinics in Korea. The purpose of this study is to assess Gonal-F FbM in a practical setting encompassing all subject groups and local practices.

Follicle stimulating hormone (FSH) is a complex hetero-dimeric glycoprotein used therapeutically to stimulate follicular development in the ovary. The technical advance of recombinant technology to manufacture FSH has resulted in a biochemically pure FSH preparation with high batch-to-batch consistency. The protein content can be reliably quantified in mass units by size exclusion high performance liquid chromatography. These developments have enabled recombinant human FSH follitropin alfa (Gonal-F) to be filled and released in vials on the basis of mass with a variability of only ±2%. In one study, the FbM batches appeared to deliver a more consistent therapeutic effect than the filled-by-bioassay batches. In another randomized trial, self-administration and subjects' satisfaction were significantly higher in the pen device group than the conventional syringe group. Local reactions at injection sites and pain were significantly higher in the conventional syringe group than in the pen device group. The authors concluded that the pen device of Gonal-F is safe, convenient, and less painful, with more subject satisfaction than the conventional syringe form.

This prospective, multicentric, observational study is planned in women using Gonal-F FbM in ovarian hyperstimulation as part of their IVF/ICSI treatment at infertility clinics in Korea. Subjects fulfilling the eligibility criteria shall be enrolled in a consecutive manner over a 9-month period (approximately 1500 subjects).

OBJECTIVES

Primary objective:

* To assess the effectiveness Gonal-F FbM

Secondary objectives:

* To assess the safety and subject convenience of Gonal-F FbM in a normal clinical practice over a period of 9 months

Eligibility Criteria:
Inclusion Criteria:

* Women who are prescribed Gonal-F FbM by their treating physician for their IVF/ICSI treatment cycle will be eligible for this study

Exclusion Criteria:

* Subjects who have hypersensitivity to follitropin alfa, FSH or to any of the excipients
* Subjects with tumors of the hypothalamus and pituitary gland
* Ovarian enlargement or cyst not due to polycystic ovarian disease
* Gynecological hemorrhages of unknown etiology
* Ovarian, uterine or mammary carcinoma
* Primary ovarian failure
* Malformations of sexual organs incompatible with pregnancy
* Fibroid tumors of the uterus incompatible with pregnancy
Stratus Versus Cirrus OCT in AMD

The Cirrus OCT provides due to the spectral domain technology a 2-fold resolution than Stratus OCT generated in a comparable amount of time. Due to this higher resolution the retinal surface and the retinal pigment epithelium can be identified more clearly, a significantly reduced number of algorithm failures is expected


Eligibility Criteria:
Inclusion Criteria:

* Age\>55 years
* Age-related macular degeneration

Exclusion Criteria:

* Not consented patients
EEG Spectrogram-guided vs. Index-guided Anesthesia for Craniotomy

In this trial, investigators aimed to compared the clinical effects between the electroencephalographic (EEG) spetrogram-guided and processed EEG index-guided multimodal general anesthesia using the combination of propofol, dexmedetomidine, remifentnil and the scalp block in patients undergoing elective craniotomy.

The multimodal general anesthesia involved the administration of combinations of antinociceptive agents and hypnotics using electroencephalographic (EEG) based monitors to achieve a balanced state of anesthesia. Traditionally, the adjustment of general anesthesia drugs has been done using instruments like the Bispectral Index (BIS), which converts frontal lobe EEG signals into a numerical range of 0-100. This allows anesthesiologists to assess drug dosage and depth of anesthesia. However, numerical conversion may not accurately reflect individual variations and cannot precisely calculate drug concentrations in the case of multiple drug combinations.

For instance, dexmedetomidine (DEX) is currently one of the most commonly used drugs in multimodal generagal anesthesia.Because each anesthetic produces distinct brain states that are readily visible in an EEG density spectral array (DSA) and can be easily interpreted by anesthesiologists, anesthetic titration based on an EEG DSA may provide additional information for anesthetic depth monitoring and may avoid the conventional 'one-index-fits-all' approach, which often ignores the influence of anesthetic drug combination. Theoretically, the anesthetic exposure in cases that involve the coadministration of dexmedetomidine can be more precise through the use of an EEG DSA than the use of BIS value. In accordant to this context, investigators have changed our institutional anesthetic propofol from BIS guidance to the DSA guidance and based on the retrospective analysis, investigators further observed the profound anesthetic-sparing effects and potential postoperative benefits of EEG DSA-guided anesthesia comparing to the BIS-guided anesthesia (doi: 10.4097/kja.23118). Therefore, further prospective randomized controlled is warranted to shape the real clinical benefits of DSA-guided multimodal general anesthesia.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing elective craniotomy

Exclusion Criteria:

* revision surgery
* heart failure
* liver cirrhosis \> Child B class
* chronic obstructive pulmonary disease