cyrilzakka/clinical-trials huggingface dataset:
Safety Study of MK-3641 and MK-7243 Co-administered in Adult Participants With Ragweed and Grass Pollen Induced Allergic Rhinitis (P08607, MK-3641-006)

The purpose of this study is to assess the safety and tolerability of MK-3641 (short ragweed \[Ambrosia artemisiifolia\] extract, SCH 039641, RAGWITEK®) sublingual tablets and MK-7243 (Timothy grass \[Phleum pratense\] extract, SCH 697243, GRASTEK®) sublingual tablets co-administered in participants 18 through 65 years of age with both ragweed- and grass polled-induced allergic rhinitis, with or without conjunctivitis and with or without asthma. The primary endpoint is the percentage of participants who experience at least one event of local swelling after co-administration of MK-3641 and MK-7243 sublingual tablets.

Events of local swelling include pharyngeal edema, laryngeal edema, mouth edema, oropharyngeal swelling, palatal edema, tongue swelling/edema or throat tightness.

Eligibility Criteria:
Inclusion Criteria:

* Clinical history of physician-diagnosed ragweed- and grass pollen-induced rhinitis with or without conjunctivitis of \>1 year duration, with or without asthma
* Female participants of childbearing potential must have a negative urine pregnancy test at Screening and Randomization Visits and must agree to remain abstinent or use (or have their partner use) any one of the acceptable methods of birth control within the projected duration of the study. Acceptable methods of birth control are: intrauterine device (IUD), diaphragm with spermicide, contraceptive sponge, condom, vasectomy, hormonal contraception.

Exclusion Criteria:

* Unstable, uncontrolled or severe asthma treated with long-acting beta agonists (LABAs) at the time of Screening
* Received immunosuppressive treatment within 3 months prior to Randomization (except steroids for allergic reactions other than asthma)
* History of anaphylaxis with cardiorespiratory symptoms with prior immunotherapy, unknown cause, or inhalant allergen
* Diagnosis of eosinophilic esophagitis
* History of any severe systemic allergic reaction or any severe local reaction to sublingual allergen immunotherapy
* Female and breastfeeding, pregnant or intending to become pregnant
* Received another form of allergen immunotherapy with the past month
* Previously exposed to MK-3641 (RAGWITEK®) or other sublingual ragweed immunotherapy
* Previously exposed to MK-7243 (GRASTEK®) or other sublingual grass immunotherapy
* Known history of allergy, hypersensitivity, or intolerance to the excipient ingredients of the study drug (except for Ambrosia artemisiifolia and/or Phleum pratense), or self-injectable epinephrine
* Unable to or will not comply with the use of self-injectable epinephrine
* Used an investigational drug within 30 days prior to Screening Visit, or plans to participate in another interventional clinical trial during the duration of this trial
* Family member of the investigational or sponsor staff involved in this trial
* Participating in this same trial at another investigational site.
Contrast Sensitivity and Diabetic Macular Edema

Contrast sensitivity is a tool use to evaluate the visual function in all patients. It can be modified by different pathologies or by age. The purpose of this study is to identify the changes that could be in relationship with the course of diabetic retinopathy comparing with diabetic patient without retinopathy and in patients with diabetic macular edema so if it is a difference, research for therapeutic strategies to improve it in this patients.

Contrast sensitivity is defined as a subjective measurement, it is the ability to separate the image between figure and background, taking into account the minimum amount of light required; it is evaluated by the contrast threshold, which is the smallest amount of contrast needed to be able to see a target and solve their characteristics, would be his reciprocal value. Medina et al. curve reported in healthy Mexicans SC 5 to 80, where \> 51 years have decreased compared to contrast sensitivity studies international; further that contrast sensitivity in older groups of 41 years is decreased high frequency.

Eligibility Criteria:
Inclusion Criteria:

* DIABETIC PATIENTS
* 40-60 YEARS OLD
* ANY GENDER
* VISUAL ACUITY \>0.25 IN DECIMAL EQUIVALENT,

Exclusion Criteria:

* PATIENTS WITH CATARACTS OR OTHER MACULOPATHY
* PATIENTS WITH CONTACT LENSES
* PATIENTS WITH REFRACTIVE ERROR \>6.00DP
* PATIENTS WITH PREVIOUS OCULAR SURGERY
Efficacy Study of IZN-6D4 Gel for the Treatment of Diabetic Foot Ulcers

The purpose of this study is to determine if topical application of a hydrogel that contains plant extracts will improve healing of diabetic foot ulcers when compared to treatment with a hydrogel alone.

This is a multi center, double-blind, randomized, placebo-controlled trial. A total of 80 patients will be randomized according to a 1: 1 randomization schedule. To participate in the trial, patients must have a current Diabetic Foot Ulcer (DFU) for between 60 days to 2 years at the screening visit. In the 2-week period between screening and baseline visit, the patient's DFU must not have healed by 30% or more, in wound area, while being treated with SWT twice a week during this screening period.

During the treatment period of 4 weeks all patients will be examined on a weekly basis by the site staff. Treatment with SWT plus the study gel (IZN-6D4 Gel or placebo gel) (including any necessary debridement) will be administered at these weekly visits. In addition, the patient or caregiver will be trained to perform SWT plus the study treatment at home once midweek between visits.

Eligibility Criteria:
Inclusion Criteria:

* Current diagnosis of diabetes mellitus type 1 or 2
* Foot ulcer Wagner grade 1 or 2
* Ulcer between 1 square cm and 8 square cm present for at least 60 days and not more than two years
* HgbA1C less than 10%
* Able to comply with all procedures

Exclusion Criteria:

* Wound area decrease of greater than 30% between screening and baseline visits
* Gangrene on any part of the affected foot
* Pregnancy or lactation
Train Your Brain and Exercise Your Heart? Advancing the Treatment for Attention Deficit Hyperactivity Disorder (ADHD)

Attention Deficit Hyperactivity Disorder (ADHD) is a developmental disorder that has a severe impact on a child's life and society. The core symptoms are attention problems, hyperactivity and impulsivity. These symptoms are related to disruptions in neurocognitive functions (such as inhibition: the ability to stop behavior) and disruptions in cortical regulation (such as 'cortical underarousal' as measured with the electroencephalogram). To date, the only evidence-based treatment is pharmacological. Medication is not effective in 20-30% of the children with ADHD and it can have side effects. The lack of alternatives for medication is a severe problem for these children and society.

Neurofeedback is becoming increasingly popular for treating ADHD. Neurofeedback is a training in which a person learns to alter its cortical regulation. Neurofeedback has been classified as 'probably effective' but its treatment effects need further empirical evidence. Non specific training effects, such as individual attention, may also contribute to treatment success. In this research project the investigators compare the efficacy of neurofeedback with exercise, a second non-pharmacological treatment, that may be comparable with neurofeedback in terms of non-specific effects. Exercise is also a promising treatment because of its positive effects on behavior, neurocognition in several patient groups. For these reasons, exercise deserves systematic research in ADHD. Furthermore, the investigators compare the efficacy of these two treatments with an optimal pharmacological treatment with methylphenidate (MPH). The main question is if neurofeedback and exercise are comparable in efficacy with MPH for treating ADHD. The primary outcome measure is behaviour (symptoms of ADHD). Secondary outcome measures include neurocognition and cortical regulation. This research project will give answer to the question if neurofeedback and exercise are as effective as MPH. Furthermore, it will give insight in how these interventions will give rise to improvements in behavior.


Eligibility Criteria:
Inclusion Criteria:

* ADHD diagnosis
* IQ above 80

Exclusion Criteria:

* neurological disorder
* severe physical or cognitive disability
Study of ONO-8577 in Patients With Overactive Bladder

The objective of the study is to evaluate the efficacy and safety of ONO-8577 compared to combination of solifenacin succinate and mirabegron or placebo for overactive bladder


Eligibility Criteria:
Inclusion Criteria:

* Patient with symptoms of overactive bladder for ≥6 months

Exclusion Criteria:

* Patient with genuine stress incontinence, or with stress-predominant mixed urinary incontinence
* Patient who has never experienced urge urinary incontinence during disease duration of overactive bladder
Evaluation of a Mobile Therapy for Elevated Depressive Symptoms

The purpose of this research study is to evaluate a mobile application (app) for depression treatment. Participants will be randomly assigned to either receive the mobile app, "Moodivate", or not. If provided with Moodivate, participants will be asked to use the app regularly, at least once per day, throughout the study duration. Participants will be asked to complete electronic questionnaire measures throughout the study period. Participation in this study will take about 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Elevated depressive symptoms, defined as a score of \> 10 on the Patient Health Questionnaire-9 (PHQ-9)57
* Age 18+
* Currently own an iOS- or Android-compatible smartphone
* Report willingness to utilize a mobile app for the treatment of depressed mood (response of "yes" on yes/no item)
* Have a current, valid e-mail address that is checked at least once per day or have regular access to text messages (to access follow-up assessments)
* Enrolled in Epic's MyChart program
* English fluency

Exclusion Criteria:

- Current suicidal ideation at study screening, defined as a response \>1 (several days) on item nine of the PHQ-9 ("Over the last two weeks, how often have you been bothered by thoughts that you would be better off dead, or of hurting yourself?")
PRP for Rotator Cuff Tears

Regenerative medicine, specifically orthobiologics is a hot topic in the community and in Sports Medicine. Riding the hype curve of a new treatment can be great when offering new procedures to patients. However, as the excitement regarding potential benefits of orthobiologics grows, it is valuable to grow the body of literature on their safety and efficacy in various musculoskeletal conditions. Furthering the body of data regarding which musculoskeletal conditions may benefit most from these treatments and which may not can help guide physicians on when to incorporate orthobiologics into clinical practice. More robust data can help physicians guide patients and patient expectations when discussing treatment options.

Platelet rich plasma (PRP) in musculoskeletal medicine is most commonly used to treat tendinopathies and degenerative joint disease. The American Medical Society for Sports Medicine released a position statement in November of 2021 summarizing meta-analysis and systemic review data evaluating efficacy and major adverse events of PRP for tendinopathy and osteoarthritis1. At this time, the most robust data exists for lateral epicondylopathy as multiple randomized controlled trials demonstrate positive response to PRP. Gluteus medius tendinopathy and plantar fasciaopathy similarly have positive data. In Achilles tendinopathy, well designed RCTs have shown no difference between PRP and saline injections. These data should help guide physicians in responsible use and patient counseling.

Data from Hurley et al. suggest PRP may augment rotator cuff repair with improved rates of healing and reduced overall pain. However, there are limited high quality studies on the efficacy of PRP alone in partial rotator cuff tear. Partial rotator cuff tear is a common musculoskeletal complaint that can be treated with conservative measures such as physical therapy and corticosteroid injection. It can also be treated with surgical intervention if those modalities provide incomplete or inadequate pain relief and functional restoration. This study aims to evaluate if PRP is an efficacious treatment modality for partial rotator cuff tear.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with symptomatic partial rotator cuff tear of one rotator cuff tendon diagnosed on imaging with MRI
* Adult patients with symptomatic partial rotator cuff tear of one rotator cuff tendon diagnosed on imaging with ultrasound.

Exclusion Criteria:

* Patients who have had any an intervention within the past three months (CSI, PRP, prolotherapy)
* Patient with previous surgical interventions on the same rotator cuff.
* Patients on aspirin who cannot discontinue medication 1 week prior and 6 weeks after the procedure.
* Patients who decline to discontinue anti-inflammatory medications or supplements for 1 week prior and 6 weeks after the procedure.
* Any procedure that utilized less than 2-3 cc of PRP
* Patients that require blood to be drawn twice on the same day.
Prevention and Screening Towards Elimination of Cervical Cancer

The research project applies the protocol of the World Health Organisation for screening of cervical cancer, with testing of hrHPV as first screening, followed by Visual Inspection of the cervix with Acetic Acid for hrHPV-positive women and for women with minor lesions thermo-ablation of affected areas. This procedure is applied in Uganda, India and Bangladesh. In Slovakia hrHPV-positive women are offered Pap-smear and for women with Pap IV lis excision.

The project performs community sensitisation and mobilisation in dedicated geographical areas and populations, to inform women and relatives about the importance of screening for cervical cancer.

To eligible women self-tests for hrHPV are offered, which can be applied at home and investigated in dedicated field-laboratories. Women who are hrHPV positive are invited for further diagnosis. In Uganda, India and Bangladesh Visual Inspection of the cervix with Acetic Acid is performed. In Slovakia Pap-smear. In case dysplasia is found, further treatment is performed with cryotherapy or thermo-ablation. Cases of suspect invasive cervical cancer are referred to hospitals for diagnosis and treatment.

Eligibility Criteria:
Inclusion Criteria:

* Female in eligible age group
* Ability to give informed consent and participate in study

Exclusion Criteria:

* Clinical signs of cervical carcinoma
* Menstruation or other vaginal blood loss
Investigation on the Epidemic Prevention Effect of Using Chinese Medicine During the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Outbreak.

Taking a regional hospital as an example, the investigators will discuss the changes in the community cumulative incidence rate(CIR) and the epidemic prevention effect of using Chinese medicine during the SARS-CoV-2 outbreak.

Main purpose:

Retrospective case study to explore the effect of traditional Chinese medicine on the prevention of SARS-CoV-2.

Secondary purpose:

If there are related side effects after taking Chinese medicine.

The large-scale coronavirus epidemic is a major global public health challenge in the 21st century. Since the 2003 Severe acute respiratory syndrome (SARS) epidemic spread globally and caused hundreds of deaths, the Middle East respiratory syndrome (Middle East respiratory syndrome, MERS) and coronavirus disease 2019(COVID-19) has caused a large-scale global spread and also caused a huge impact on the public health and medical system. In the country's current epidemic (Aug 1, 2021), more than 15,000 people have been diagnosed, and the number of deaths has exceeded 800. Among them, the Taipei epidemic is the most severe, and the Wanhua District of Taipei City is the hot zone. The investigators will discuss the changes in accumulation incidence rate(CIR) of the community and the epidemic prevention effect of using Chinese medicine during the SARS-CoV-2 outbreak.

This is a retrospective case study to explore the effect of traditional Chinese medicine on the prevention of SARS-CoV-2 and discuss if there are related side effects after taking Chinese medicine.

Eligibility Criteria:
Inclusion Criteria:

- From January 1, 2020 to July 31, 2021, Chinese medicine is used for patients with new coronary pneumonia epidemic prevention.

Exclusion Criteria:

1. Patients who do not use traditional Chinese medicine for the prevention of new coronary pneumonia.
2. Patients who have signed and refused to provide medical records.
Development of Gourmet Healthy Cooking Workshop for Cancer Patients

Subjects that participate in the practical workshop will improve their metabolic indexes, control their weight and improve their quality of life, in contrast to the participants that will take part in the nutritional consulting sessions

Participants will be randomly assigned to a dietary consultation-only control group or to a gourmet medical cooking workshop. The workshop will consist of 6 lessons with the following lessons: introduction, caloric density of food, fats, vegetable and fruits, Whole grains and legumes, Healthy desserts . All the lessons will start with half an hour theoretical introduction, followed by a 2.5 hours "hands on" session under supervision of a medical chef. The study population will include women receiving adjuvant chemotherapy for breast cancer. 72 patients will be recruited and will be randomly divided into two groups: an intervention group of 36 will commence the workshop during 2007 and a control group of 36 who will take part in dietitian consulting sessions only.

Eligibility Criteria:
Inclusion Criteria:

* Adjuvant chemotherapy
Work Hour Reductions, Medical Errors, and Intern Well-Being at Providence St. Vincent Medical Center Intensive Care Unit

The purpose of this study is to determine whether reducing intern work hours and eliminating extended shifts in the intensive care unit will reduce prescribing errors and improve intern well-being.

Each intern enrolled will complete three 4-week rotations in the intensive care unit (ICU) at Providence St. Vincent Medical Center. Each intern will complete at least one traditional schedule and one intervention schedule. The traditional schedule consists of an 80-hour work week with overnight call every third night. The longest shift on the traditional schedule is 30 hours. The intervention schedule consists of a 60-hour work week which eliminates overnight call by assigning a variety of shifts ranging from 8 to 16 hours in length.

Eligibility Criteria:
Inclusion Criteria:

* Interns rotating at Providence St. Vincent Medical Center ICU

Exclusion Criteria:

* Diagnosis of narcolepsy
An Intervention for Primary Caregivers to Improve Outcomes in Children With Severe Malnutrition

This cluster-randomized controlled trial will evaluate the effectiveness of a four-day hospital-based intervention program for primary caregivers of children with severe malnutrition.

Mortality rates remain high in hospitalized children with severe malnutrition and long-term impairments in child development exist in children that do survive. Hospitalized children with severe malnutrition will be allocated to an intervention or standard of care group in each one-week cycle. The intervention package consists of a counseling and support program that includes three modules: 1) psychosocial stimulation; 2) nutrition and feeding; and 3) water, sanitation and hygiene. Assessments will be done at baseline (t=0) and follow-up (t=6 months). The primary outcome is child development, which will be assessed using the Malawi Developmental Assessment Tool, a validated tool for gross and fine motor, language, and social development.

Eligibility Criteria:
Inclusion Criteria:

* Child 6-59 months of age with severe malnutrition
* Child admitted to hospital because of severe malnutritionwith medical complications as defined by the current World Health Organization guidelines or has no appetite if there are no complications
* Primary caregiver (self-identified) present at hospital.

Exclusion Criteria:

* Primary caregiver declined to give informed consent;
* Child with a known terminal illness (i.e. in the opinion of the treating physician the child is likely to die within six months)
* Child requires a surgical procedure.
Effect of Speed,Agility and Quickness Training on Technical Skills in Football Players

The study is designed to determine the effectiveness of Speed, Agility and Quickness training on technical skills in football players

Football is a fast-paced, dynamic sport that requires expert movements. The goal of the game is to outscore your opponent in terms of goals scored. Players must perform a variety of expert movements, both with and without the ball, to achieve this goal. 'The learned ability to bring about predetermined results with utmost assurance, frequently with the least investment of time or energy or both,' according to an initial definition of talent. 'The constant output of goal-oriented movements, which are taught and unique to the job,' according to a more modern definition of competence. It is critical for players to have the fundamental motor abilities, such as running, agility, and acceleration, in order to learn and execute soccer skills effectively. Fundamental motor skills are seen as essential precursors or related factors to technical skills and therefore excellence in soccer.Furthermore, through a variety of soccer-specific activities, the SAQ training system consolidates speed, agility, and quickness. All exercises are carried out with appropriate biomechanical movement structures, resulting in significant energy and time savings. Aside from major abilities, power performance necessitates optimal joint mobility, dynamic balance, an appropriate locomotors system, and energy generation, among other things.

Eligibility Criteria:
Inclusion Criteria:

* Male players
* Age group of 18 years to 25 years.
* The study includes players, who are playing form 6 months to 1 year.

Exclusion Criteria:

* Players with any disability
* Injured players
* Players with psychological issues
* Players who are on any sort of medication