cyrilzakka/clinical-trials huggingface dataset:
Genetic and Risk Factors in Exfoliation Glaucoma Patients

Prospective non-randomised cohort study enrolling patients with exfoliation glaucoma. All patients were ophthalmological examined at inclusion. Blood samples were taken for genetic analysis.

Patients \& examinations In this prospective non-randomised cohort study, the investigators enrolled patients with exfoliation glaucoma at the Ophthalmology Department of the Skaraborg's Hospital, Skövde, and Sahlgrenska University Hospital, Gothenburg, from 1st January, 2014, to 31st December, 2017. All patients were followed-up for three years ± three months. Informed consent was obtained from all patients. The study protocol was granted ethical approval by the University of Gothenburg (DN:119-12). The study was performed in accordance with the tenets of the Declaration of Helsinki.

At the recruiting visit, an ophthalmic nurse checked the visual acuity of patients with a Snellen's chart and performed a visual field test. Humphrey Field Analysis was performed using the software threshold 24-2. Subsequently, an ophthalmologist measured the intracoular pressure (IOP) with a Goldmann applanation tonometer and performed slit-lamp biomicroscopy, including gonioscopy. Pupils were then dilated with 2.5% phenylephrine and 0.5% tropicamide. After 20 min, the presence of exfoliation was confirmed, and the optic nerve was assessed using a 90-D lens. Subsequently, the central corneal thickness (CCT) was measured using an ultrasound device. The average value of seven measurements was automatically calculated. At the end of the visit, blood samples were collected. The number of medicines was registered as the number of compounds and not the number of bottles used.

Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of exfoliation glaucoma based on the criteria established by the European Glaucoma Society Terminology and Guidelines for Glaucoma, i.e., an untreated IOP of ≥21 mmHg, an open anterior chamber angle, glaucomatous visual field defects (at least two repeatable Humphrey 24-2 tests), glaucomatous optic nerve damage, and the presence of exfoliation material.
* Patients must performed at least five reliable visual field tests during the 3-year follow-up, with reliability defined as false positives ≤15%, false negatives ≤20%, and/or fixation losses ≤30%.
* Age ≤85 years at the recruiting visit.

Exclusion Criteria:

* A diagnosis of advanced glaucoma defined as mean deviation (MD) ≥18 decibel (dB) and/or visual field index (VFI) ≤40% because of 'floor effects,' in which further loss of visual field defects can no longer be detected.
* History of glaucoma surgery other than uneventful cataract surgery or selective laser trabeculoplasty (SLT).
* Other eye diseases (central venous occlusion, retinal detachment, etc.) that could affect the visual fields during the 3-year follow-up.
Air Pollution Study: The Effect of Ozone on the Lung

The purpose of the study is to better understand the mechanisms of lung injury from ozone exposure. Subjects will participate in two exposure sessions: filtered air and 0.2 ppm ozone. Subjects will be asked to produce sputum through coughing after each exposure. The samples will be analyzed for macrophage activity.

Subjects will be asked to come to the Rutgers EOHSI clinical center (Piscataway, NJ) for 5 study visits. A physical exam to determine eligibility will be done at the first study visit. If the subject is healthy and able to produce a sputum sample, he/she will then be scheduled for 2 3-hour exposure visits. One exposure will be to clean air and the other exposure will be to 0.2 ppm ozone. During the exposures, subjects will be requested to ride an exercise bicycle intermittently (approximately every 15 minutes). A follow-up visit for sputum collection will be scheduled either 24, 48, or 72 hours after each exposure visit. Blood, urine, and exhaled breath samples will also be collected at each visit.

Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women

Exclusion Criteria:

* Cardiovascular disease
* Respiratory disease
* Diabetes
* Pregnancy
* HIV infection
* History of smoking within the last 5 years
* Daily use of antioxidant supplements (e.g., Vitamin C/E, selenium, beta-carotene, lycopene, lutein, zeaxanthin, or ginkgo biloba)
* Orthopedic or rheumatological conditions that would interfere with cycle use
App Reminder on ASA Adherence

The purpose of this study is to explore the impact of using a smartphone app reminder on medication adherence twice daily in adults prescribed 81 milligrams of aspirin for 35 days as anti-thrombotic therapy after knee or hip arthroplasty.

This study will randomly assign participants to get usual postoperative care which is teaching with verbal instructions and printed information about taking the aspirin at the time of discharge, or to have an app on your smartphone with preset reminders in addition to usual postoperative discharge teaching after surgery.

The purpose of this study is to evaluate the impact of using a smartphone application (app) reminder on medication adherence twice daily in 200 adults prescribed 81 milligrams of aspirin (ASA) for 35 days as anti-thrombotic therapy after knee or hip arthroplasty. The aim is to determine if an app downloaded on a smartphone that reminds patients twice a day to take their ASA as prescribed will improve ASA adherence and clinical outcomes for patients after total knee and total hip joint arthroplasty compared to those in the usual care.

This is a two group, randomized control study with random assignment into the control group for usual care or the intervention group to receive a medication reminder app for their smart phone (daily for 35 days) plus usual care. Participants will receive a baseline interview for demographic and other data and 36 day follow-up assessment, both conducted in person.

Eligibility Criteria:
Inclusion Criteria:

* Prescribed aspirin 81 mg twice a day for 35 days
* Ability to write and speak English
* Have a smart phone with the capacity to download and set an app
* Own and use a smart phone for communication purposes

Exclusion Criteria:

* Diagnosis of mental illness
* Do not own a smart phone
Effects of Flow Magnitude on Cardiorespiratory Stability During Nasal High Flow Therapy in Preterm Infants

Premature babies often need help breathing for a longer period of time. Traditionally, this is done with a breathing aid called NCPAP (nasal continuous positive airway pressure). This treatment is safe and effective, but it is very time-consuming and can sometimes have side effects. In the present research project, the investigators want to find out whether another type of breathing aid called NHF (nasal high flow therapy) is just as effective for stable premature babies. The investigators suspect that NHF is just as effective, but easier to use and more comfortable.

This is a multi center parallel group three arm randomized controlled clinical trial investigating cardiorespiratory stability in stable preterm infants receiving NHF.

Currently, NCPAP remains the gold standard for administration of prolonged non-invasive ventilatory support in very preterm infants. NHF is a promising method for tailored, less invasive long-term ventilatory support for preterm infants. If ventilatory support with NHF is similarly effective to conventional NCPAP in stable preterm infants, clinicians are likely to adopt this method for widespread clinical use because of its improved comfort and potential other benefits. Primary aim of this trial is to examine cardiorespiratory stability in preterm infants treated with two commonly used NHF flowrates (Interventional group 1 and 2) in comparison to NCPAP (Comparator). Secondary aim is to examine potential comfort-related beneficial effects of NHF.

Eligibility Criteria:
Inclusion Criteria:

Inclusion if all apply.

* Preterm infants up to 31+6 weeks GA admitted to the Division of Neonatology at Inselspital Bern, Switzerland or Division of Neonatology at the University Medical Center of the Johannes Gutenberg-University Mainz, Germany (inborn or outborn)
* \>2nd day of life (defined as date day)
* Stable on NCPAP 6 cm H2O for ≥ 24 hours, defined as:

  * ≤ 2 apneas with concomitant bradycardias (\<100/min) per hour for the previous 6 hours
  * FiO2 ≤ 0.3 and not increasing
  * No significant chest recessions (Silverman Score \< 5)
  * Respiratory rate ≤ 60/min
  * No need for intermittent positive pressure ventilation
* Parents with an age 18+ years
* Written parental informed consent (or other legal representative)

Exclusion Criteria:

Exclusion if any applies.

* Significant fetal anomalies
* Primary palliative care
* Stable on NCPAP 6 cm H2O according to stability criteria for more than 120 hours
Which Needs for Premature New-born Babies' Parents Facing Environmental and Social Difficulties ?

This study aims to understand parents' needs regarding social difficulties faced in a child's preterm birth context.

* From parents collected during semi-structured interviews.
* To highlight the social, environmental and economic difficulties that parents have encountered in the context of the premature birth of their child (before birth, during hospitalization and return home).
* Determine the possible help they need in the psychosocial and environmental field.
* Difficulties of the parents we expected:

  * Pre-existing child birth: poor socio-economic environment, unstable social, family and / or occupational status, poorly followed pregnancy, etc.
  * After the birth: professional break-up, custody of other children of the siblings, balance of the couple, financial loss, isolation, transportation problems to get to the hospital, etc.
* Needs we expected :

  * Before birth: measures to prevent prematurity, social and/or psychological support, information, etc.
  * After the birth: support of the entourage, interview with a social worker, help to come in hospital, help to live near the hospital, parental leave, project and long-term support, doctor referred, relationship with professionals in ambulatory (psychologist, Infant and Maternal Protection ...), preparation of the arrival of the child at home +/- home improvement, etc.

Eligibility Criteria:
Inclusion Criteria:

* Parents (father or mother ) of a premature new-born baby (\< 37 SA) hospitalised in Besancon University Hospital at birth.

Exclusion Criteria:

* Parents \< 18 years old
* Refusing to participate
Usage of Acyclovir for Suppression of HIV-1 and HSV-2 Coinfected Persons in Cameroon

The study proposed that both clinical and subclinical HSV reactivation is associated with increased HIV shedding from mucosal surfaces, which may increase the infectiousness of HIV-1/HSV-2 coinfected persons. To test this hypothesis, we will control HSV reactivation with acyclovir, a safe medication that is proven to reduce HSV shedding, and measure HIV levels in blood, genital, and pharyngeal secretions. The study hypothesizes that acyclovir will reduce HIV shedding from mucosal surfaces of HIV-1/HSV-2 coinfected individuals.

The main objective is to assess the reduction in genital HIV-1 shedding associated with daily acyclovir for suppression of HSV-2 reactivation.

All patients will be treated with the usual antibiotic treatment for any sexually transmitted infections that are diagnosed during the study. In addition, half will receive acyclovir for 8 weeks , whilst the other half will receive a placebo for 8 weeks. The study medication will reverse in the second 8 weeks of the study. The patients will attend the clinic 3 times per week during the first and the last 8 weeks of the study and once every week during the washout period in the middle of the study - for a total of 18 weeks per participant. At each visit genital and oral samples will be collected. A blood sample will also be collected. For women participants, pregnancy test will be performed. The clinic will provide both pre- and post-HIV test counseling.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old and above
* Documented HIV-seropositive
* HSV-2 seropositive as determined by Focus EIA
* Not intending to move out of the area for the duration of study participation
* Willing and able to:

  1. provide independent written informed consent
  2. undergo clinical evaluations
  3. take study drug as directed
  4. adhere to follow-up schedule
* Bacterial STDs (symptomatic STD syndromes or laboratory-confirmed asymptomatic gonorrhea, chlamydia, syphilis) are treated within two weeks if study enrollment and random assignment.

Exclusion Criteria:

* Women who meet any of the following criteria are not eligible for this study.

  1. Known history of adverse reaction to acyclovir
  2. Planned open label use of acyclovir, valacyclovir, or famciclovir
  3. Positive pregnancy test
  4. Active opportunistic infection
The Joint Effect of Air Pollution and Exercise on Cognitive Function

A double-blind randomized controlled trial design is used in this study. A mixed design of 2 (pollution reduction group vs. no pollution reduction group) × 3 (high intensity intermittent exercise \[HIIT\], moderate intensity of aerobic exercise \[MICT\] and control group \[CONT\]) is used. 93 subjects recruited by advertising will be randomly divided into 6 groups: high intensity exercise group (pollution reduction vs no pollution reduction), moderate intensity aerobic exercise group (pollution reduction vs no pollution reduction) and Stretching group (Control) (pollution reduction vs no pollution reduction).

Environmental intervention program In the pollution reduction groups, the air purification system is used 2 hours before the subjects entered the room to minimize the indoor PM2.5 and PM10.

Exercise intervention program including HIIT, MICT and Stretching (Control) group :

The VO2max of all subjects are measured one week before the experiment. HIIT program: 20 minutes exercise of HIIT (1min of 100% VO2max and 1min of 50% VO2max alternately) and 10 minutes of warm-up and relaxation.

MICT program: 20 minutes exercise of 70-75% VO2max and 10 minutes of warm-up and relaxation.

Stretching control group: 30 minutes of stretching, posture adjustment and rehabilitation courses taught by professional therapists.

Eligibility Criteria:
Inclusion Criteria:

* No regular exercise in the past six months;
* Healthy people without history of disease;
* Aged between 20 and 30 years old.

Exclusion Criteria:

* Professional athletes;
* Regular exercise in the past six months;
* People who are injured or have a history of disease in the past six months;
* People who have a history of taking medicine in the past six months.
Luminance RED for Canker Sores

Canker sores, also called aphthous ulcers, are small, shallow lesions that develop on the soft tissues in your mouth or at the base of your gums. Unlike cold sores, canker sores don't occur on the surface of your lips and they aren't contagious. They can be painful, however, and can make eating and talking difficult. Recurrent aphthous ulcer stomatitis (RAS) is characterized by recurrent bouts of solitary or multiple shallow painful ulcers, at intervals of a few months to a few days in patients who are otherwise well.

Low Level Laser Therapy (LLLT) sometimes known as Low Level Light Therapy or Photobiomodulation (PBM) is a low-intensity light therapy. The effect is photochemical not thermal. The light triggers biochemical changes within cells and can be compared to the process of photosynthesis in plants, where the photons are absorbed by cellular photoreceptors, which trigger chemical changes.

The main medical usage of LLLT is for pain and inflammation reduction, promoting the regeneration of different tissues and preventing damage to tissues. With the use of the appropriate power (from 5 to 200mW) and wavelength (600-900nm), the therapy brings anti-inflammatory and analgesic results aiding in wound healing. The mechanism of action of LLLT may be very beneficial in the treatment of oral erosions and ulcers, however, very few studies have been performed on the treatment of RAS with LLLT. There are few reports on accelerated healing in erosive mucocutaneous disorders and they are often presented as a case series rather than large randomized clinical trials. The effects on skin wound healing and periodontal inflammation management with laser biostimulation suggest that this treatment modality may also be useful for oral erosive conditions.

This clinical trial aims to evaluate the effect of the Luminance RED device on the management of RAS.


Eligibility Criteria:
Inclusion Criteria:

* Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
* 18 years and older.
* Self report canker sore outbreaks once every 30 days or more frequent
* Understands and is willing, able and likely to comply with all study procedures and restrictions.
* No previous experience of LLLT.
* United States resident.
* Willingness and ability to submit a $49 deposit using a credit card for the device.

Exclusion Criteria:

* Patients with a known systemic disease that predisposes them to RAS (e.g., Behçet disease) or undergoing systemic treatment for RAS.
* The presence of a serious medical condition.
* Currently known to be pregnant or breastfeeding
* Patients treated with topical or systemic medication for RAS, such as corticosteroid therapy, antibiotics or analgesics during the previous month.
Efficacy of an Investigational Thermal Rehab Machine on Body Cooling in Hyperthermic Individuals

Exertional heat stroke (EHS) is an emergency medical condition that is prevalent in military soldiers, athletes, and laborers. It is diagnosed when the rectal temperature is above 40°C with the presence of central nervous dysfunction (altered mental status). The gold standard method of care for EHS is immediate onsite whole body cooling using cold-water immersion (cooling rates \>0.15°C•min-1), which is reported to have the highest cooling rate. In the treatment of EHS, selecting a cooling modality with a high cooling rate becomes crucial to minimize the time above the critical threshold of body temperature at 40°C to less than 30 minutes for the best chance of survival and to minimize the severity of prognosis. However, in situations where cold water immersion is not feasible (in certain military, firefighter, or other remote settings), other cooling modalities must be available that have a cooling capacity similar to that of cold-water immersion. In this proposed study, the investigators aim to examine the cooling rates of the Polar Breeze® device (developed by Statim Technologies, LLC, Clearwater, FL) compared to rotating ice towels, a cooling method often recommended by sports medicine professionals as an alternative to cold-water immersion, and passive rest in participants with exercise-induced hyperthermia.


Eligibility Criteria:
Inclusion Criteria:

* male between the ages of 18-35.
* recreationally active (regularly exercise at a minimum of 4-5 times per week for greater than 30 minutes per session)

Exclusion Criteria:

* chronic health problems,
* fever or current illness at the time of testing
* history of cardiovascular, metabolic, or respiratory disease
* current musculoskeletal injury that limits physical activity
* history of exertional heat illness in the past three years.
Changes in Physical Functioning in Patients With COPD During Therapy With a Combination Inhalation Therapy

The decrease in physical activity due to increasing dyspnoea that over time leads to a steadily worsening condition and increasing restriction of physical functioning is a key problem for COPD patients and affects even the early stages.

Clinical studies to investigate both Spiriva® and Striverdi® Respimat® have demonstrated a marked improvement in physical exercise capacity.

However, there have so far been no data from the daily practice setting about everyday functioning on combination treatment with Spiriva® Respimat® plus Striverdi® Respimat® or Spiriva® 18 Mikrogramm plus Striverdi® Respimat® in patients requiring treatment with 2 long-acting bronchodilators.

The objective of this NIS is to measure changes in physical functioning as a surrogate for physical activity and exercise capacity in COPD patients on treatment with Spiriva® Respimat® plus Striverdi® Respimat® or Spiriva® 18 Mikrogramm plus Striverdi® Respimat® in routine daily treatment (so-called real life setting).


Eligibility Criteria:
Inclusion criteria:

* Female and male patients \>= 40 years
* COPD GOLD 2014 B - D
* Treatment with Spiriva® Respimat® plus Striverdi® Respimat® or Spiriva® 18 Microgramm plus Striverdi® Respimat® acc. to the Summary of Product Characteristics (SmPC), no change of routine diagnostics and treatment
* Signed informed consent form before inclusion into the non-interventional study (NIS)

Exclusion criteria:

* Patients with contraindications acc. to the Summary of Product Characteristics (SmPC)
* pregnant and breastfeeding women
* patients who are taking part in a different non-interventional study (NIS) or an interventional clinical study at the same time are not to be enrolled
Markers of Disease Progression and Gait Within the Parkinsonian Population

The aim of the project is to evaluate disease progression of patients with Parkinsonian syndrome of various severity through regular home-based gait parameters analysis.

We identified several steps in this project:

1. Acquisition of gait data in 120 patients with Parkinsonism at different stages in hospital and ecological condition (during 10 days at home), in a repetitive manner:

   1. 30 Early PD patients, before 3 years of disease duration (MDS criteria, 2018)
   2. 30 PD patients with motor fluctuations (5 to 8 years of disease duration) (MDS criteria, 2018)
   3. 30 PD patients with FoG (10 years of disease duration) (MDS criteria, 2018)
   4. 30 patients with MSA (less than 5 years after the first symptom)
2. Control groups will be composed by 30 healthy volunteers Correlation analysis with clinical measurements and biomarkers, namely blood biomarkers for neurodegeneration (4HN, NFLT ...) and multimodal MRI repeated assessments (Iron overload, inflammation and degeneration) and genetic panel for common haplotypes involved in Parkinsonism.


Eligibility Criteria:
Inclusion Criteria:

PD Patients:

* Age: from 40 to 80 years
* Absence of intercurrent pathology that may interfere with the purpose of the study (rheumatologic or orthopedic condition, cardiac, severe pulmonary disease that may limit the perimeter of walking)

Each group will be composed of:

* 30 PD with a disease duration \< 3 years
* 30 PD with a disease duration between 5 to 8 years
* 30 PD with a disease duration \> 10 years MSA Patients
* Age \> 30 years old
* \< 5 years of disease duration
* deemed by the physicians to be able to walk at 1 year

Healthy subjects

• Similar age and sex distribution

For all

* Absence of intercurrent pathology that may interfere with the purpose of the study (rheumatologic or orthopedic condition, cardiac, severe pulmonary disease that may limit the perimeter of walking)
* Absence of cognitive disorders (MoCA\> 24/30 according to the MDS criteria)
* Stable treatment for at least 2 weeks before inclusion
* Ability to walk at least 100 meters
* Have an affiliation to the social security or equivalent
* Have signed an informed consent

Exclusion Criteria:

* STN DBS for PD patients
* Intraduodeno-jejunal levodopa infusion (duodopa)
* Inability to walk without aid (walker or walking stick)