cyrilzakka/clinical-trials huggingface dataset:
Reducing Adolescent Sexual and Mental Health Disparities by Increasing Access to Telemedicine and Mobile Care

Investigators will attend a series of community outreach events that provide/demonstrate telemedicine and the Children's Mercy Mobile Unit which is equipped to provide direct patient care. Investigators will engage up to 12 teen peer leaders to encourage healthcare-seeking behaviors and mobilize their social networks to attend outreach events. At all events, the mobile unit will be available for teens to (a) demonstrate the mobile unit and telehealth experience; (b) learn about Sexual and Reproductive Health/Mental Health (SRH/MH) and local care resources; (c) register for future telemedicine care; (d) acquire free over-the-counter emergency contraception, condoms, and pregnancy tests.

AccessKCTeen is a pilot clinical outreach program that uses Children Mercy's Mobile Unit and Telemedicine to demonstrate and increase access to SRH and MH. AccessKCTeen intends to focus on these central activities:

1. Education based on a peer-leader model: In collaboration with community-based partners, investigators will identify and train approximately 12 peer leaders in disseminating information and resources for MH/SRH to their social networks. Peer leaders may disseminate information in the form of sharing curated online resources or mobilizing friends to attend live educational events. Peer leaders will also help connect their friends to resources by spreading information and encouraging friends to attend CM mobile unit demonstrations. Investigators will use text messaging to engage peers in these educational events and share general health resources.
2. Mobile Unit and Telemedicine Demonstration Events: The mobile unit will be present at community events to demonstrate how in-person care could work on the unit as well as how telemedicine works. Investigators will answer questions and help adolescents get registered for telemedicine.

Eligibility Criteria:
Inclusion Criteria:

* Telemedicine or In-person Mobile unit arms: Aged 14-18 years old and Attended a Mobile Unit Demonstration
* Peer leaders: At least 14 years old

Exclusion Criteria:

* Telemedicine or In-person Mobile unit arms: Younger than 14 years old, 19 years of age or older, did not attend a Mobile Unit Demonstration, does not speak/understand English
* Peer leaders: Younger than 14 years old
LUNG ULTRASONOGRAPHY DECREASES RADIATION EXPOSURE

We aimed to decrease in the number of chest X-rays in newborns with respiratory distress, with the use of lung ultrasonography.

From January 2019 to June 2020, 104 newborn infants with respiratory distress enrolled in this study. We used bed side ultrasound as the first line tecnique for lung imaging. X-ray were taken in cases with increasing respiratory distress in spite of treatment according to diagnosis depending on USG findings. We calculated decreased number of chest X-ray for every patient and evaluated the estimated decrease in radiation exposure.

Background:

Chest X-ray is commonly used as first line imaging method to diagnose the reason of respiratory distress in NICUs. Lung ultrasound is a new diagnostic tool for lung imaging, and this method has been used more common recently in NICUs.

Objectives:

We aimed to determine the decrease in the number of chest X-rays in newborns with respiratory distress, with the use of lung ultrasonography.

Methods:

From January 2019 to June 2020, 104 newborn infants with respiratory distress enrolled in this study. We used bed side ultrasound as the first line tecnique for lung imaging. X-ray were taken in cases with increasing respiratory distress in spite of treatment according to diagnosis depending on USG findings. We calculated decreased number of chest X-ray for every patient and evaluated the estimated decrease in radiation exposure.

Eligibility Criteria:
Inclusion Criteria:

* Term or preterm neonates with respiratory distress that started within the first 24 h after birth were included if they showed at admission signs of respiratory distress defined as: tachypnea (respiratory rate \>60 breaths/min), intercostal/subcostal retractions, grunting, or FiO2 requirement \>0.21.

Exclusion Criteria:

* Patients with a diagnosis of major malformations or chromosomal abnormalities, inherited metabolic diseases, congenital muscle disease-hypotonicity, hypoxic ischemic encephalopathy were not enrolled.
Survival Outcome After Minilaparotomy for the Treatment of Colorectal Cancer

The primary aim of this study is

- to determine the difference of survival outcome (3-year overall survival, 3y OS) between after minilaparotomy and after laparoscopy..

Other aims include to determine the data below when minilaparotomy and laparoscopy are compared with each other.

* 3-year disease free survival, 3y DFS
* 5-year overall survival, 5y OS
* 5-year disease free survival, 5y DFS
* Local recurrence rate, LRR
* Postoperative complications Incidence and mortality at 30 days


Eligibility Criteria:
Inclusion Criteria:

* Colorectal cancer with pathological results.
* Colorectal cancer preliminary diagnosed during colonoscopy.
* No confirmed metastasis.
* No comorbidity of other malignancy.
* The primary tumor is less than 10 cm.
* No organ dysfunction.
* The patient and his families totally agree with the whole investigative procedure, and sign the written informed consent form.

Exclusion Criteria:

* Diagnosed with any other malignancy within 5 years.
* Comorbidity of emergent conditions like perforation.
* Former colorectal surgery history which may affects digestive tract reconstruction.
* Need combined organ resection.
* ASA grade IV or V.
* Pregnant or lactating Women.
* Severe mental diseases.
* Severe cardiopulmonary diseases which reduce operation tolerance.
* Systematic steroid therapy lasting for more than 1 month.
* Intolerant of laparoscopy.
* No written informed consent form signed.
Delivery of Yamani-15/5 Chemical Solution for PAD

This is a feasibility pilot study to evaluate the impact of local delivery of Yamani-15/5 (combination of L-Lactic acid 15% and D-Gluconic acid 5%) on vascular calcification of lower extremities in patients with severe peripheral arterial disease (PAD) who were deemed to have unreconstructable arterial disease and who have already been scheduled to undergo limb amputation (below knee or above knee amputation).


Eligibility Criteria:
Subject has severe calcific PAD who have been deemed to have unreconstructable arterial disease and who have already been scheduled to undergo limb amputation (below knee or above knee amputation).

Exclusion:

* Patients who will be undergoing amputation of the limb because of infection, osteomyelitis or cancer.
* Patients with chronic kidney disease stage V (unless on dialysis).
* Patients with liver cirrhosis.
* Patients with history of deep vein thrombosis or pulmonary embolization in the last 3 months.
* Patients with history of stroke in the last 3 months.
* Patients with unstable angina or history of myocardial infarction in the last 3 months.
* Patients with sepsis, respiratory failure, hypovolemic shock or cardiogenic shock.
* Women who are pregnant or nursing.
Efficacy and Safety of Salmon Calcitonin Nasal Spray in Improving Muscle Strength and Reducing Pain After Forearm Fracture in Postmenopausal Women

Calcitonin has been used for many years for treating osteoporosis in postmenopausal women, and it has been shown that calcitonin reduces pain after spine and hip fracture in women with osteoporosis. Therefore, this study assesses the safety and efficacy of salmon calcitonin nasal spray on muscle strength after a forearm fracture, pain, quality of life and fracture healing in postmenopausal women.


Eligibility Criteria:
Inclusion Criteria:

* Post-menopausal women, aged at least 60 years old
* Having a forearm fracture within the last 3-7 days before treatment
* Fracture is treated with either a plaster cast only, or a cast plus Kirschner wires

Exclusion Criteria:

* Multiple fractures, severe fractures, or the forearm fractured in more than one place
* Nerve damage in the forearm caused by the fracture
* Other conditions which would interfere with the grip strength measurements (e.g. swelling, paralysis, skin diseases or rheumatoid arthritis)

Other protocol-defined inclusion/exclusion criteria may apply.
Immunogenicity and Safety of Subcutaneously-administered Avonex (Interferon Beta-1a) in Multiple Sclerosis (MS) Patients

The primary objective of the study was to evaluate the immunogenicity of Avonex® (interferon beta-1a) 30 mcg when administered subcutaneously (SC) to interferon-naïve participants with relapsing multiple sclerosis. The secondary objective of this study was to evaluate the safety and tolerability of Avonex® 30 mcg when administered SC to interferon-naïve subjects with relapsing MS.


Eligibility Criteria:
Inclusion Criteria:

* Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
* Male or female aged 18- to 60-years-old, inclusive, at the time of informed consent.
* Must have a diagnosis of relapsing MS.
* Must have a screening Expanded Disability Status Scale (EDSS) score between 0 and 6.0, inclusive.
* All male subjects and female participants of child-bearing potential must practice effective contraception during the study and be willing and able to continue contraception for 30 days after their last study dose of Avonex.

Exclusion Criteria:

* History of severe allergic or anaphylactic reactions.
* Diagnosed with Primary progressive, secondary progressive, or progressive relapsing MS.
* Known allergy to any component of the Avonex formulation.
* History of any clinically significant (as determined by the investigator) cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric renal, or other major disease.
* Subjects with history of malignant disease, including solid tumors and hematologic malignancies.
* History of seizure disorder or unexplained blackouts OR history of a seizure within 3 months prior to Day 1.
* History of suicidal ideation within 3 months prior to Day 1 or an episode of severe depression within 3 months prior to Day 1. Severe depression is defined as any episode of depression that requires hospitalization, or the initiation of antidepressant therapy, or an increase in the dose of an existing regimen of antidepressant therapy.
* Clinically significant abnormal electrocardiogram (ECG) values as determined by the investigator.
* Known history of, or a positive test result for, human immunodeficiency virus (HIV).
* Known history of, or a positive test result for hepatitis C virus.
* Abnormal screening blood tests exceeding any of the limits defined below:

  1. Alanine transaminase/serum glutamate pyruvate transaminase (ALT/SGPT) greater than 2 times the upper limit of normal or aspartate transaminase/serum glutamic oxaloacetic transaminase or bilirubin.
  2. Total white blood cell count (WBC) \<3700 cells/mm
  3. Platelet count \<150,000 cells/mm
  4. Hemoglobin \<10 g/dL in female subjects; \<11 g/dL in male subjects
  5. Serum creatinine \>upper limit of normal (ULN)
  6. Prothrombin time (PT) or activated partial thromboplastin time (aPTT) \> 1.2\*ULN
Robotic Therapy and Brain Stimulation in the Early Phase After Stroke

Stroke is the second cause of death worldwide and the majority of the survivors remain with motor impairments. Inhibition of the motor cortex of the unaffected hemisphere has emerged as a potential intervention to enhance effects of other rehabilitation strategies on improvement of motor performance of the paretic upper limb. In this proof-of-concept study we will evaluate the effects of inhibition of the motor cortex of the unaffected hemisphere associated with robotic therapy on improvement of motor performance of the paretic upper limb in the early phase post-stroke.

The main goal of this study is to test the proof of concept of benefits of inhibition of the motor cortex of the unaffected hemisphere on learning evaluated by improvement in kinematics of motor performance, in patients with upper limb paresis in the early phase post-stroke. For this purpose, patients will be randomized to receive real or sham transcranial direct current stimulation before a session of robotic therapy. Data will be collected by kinematic assessment performed automatically by the robot at baseline, immediately after and 24h after the intervention.

The working hypothesis is that one session of upper limb motor training will lead to improvement of performance in metrics of kinematics, and this improvement will be maintained up to 24h after the end of the training.

Eligibility Criteria:
Inclusion Criteria:

Ischemic or hemorrhagic stroke onset from 3 days to 9 weeks before, confirmed by computed tomography or magnetic resonance imaging.

Motor impairment of an upper limb, defined as a score between 1 - 3 in the Medical Research Council Scale, for at lest one the following movements: elbow extension, shoulder flexion, or shoulder extension.

Ability to provide written informed consent.

Ability to comply with the schedule of interventions and evaluations in the protocol.

Exclusion Criteria:

Severe spasticity at the paretic elbow, wrist or fingers, defined as a score of \> 3 in the Modified Ashworth Spasticity Scale.

No active shoulder and elbow movements

Uncontrolled medical problems such as end-stage cancer or renal disease

Pregnancy

Potential contraindications to transcranial direct current stimulation: history of seizures, lesions on the scalp, intracranial metal implants, prior intracranial surgery, use of drugs that interfere on cortical excitability (such as antiepileptic drugs, benzodiazepines)

Other neurological disorders such as Parkinson's disease

Psychiatric illness

Aphasia or severe cognitive deficits that compromise comprehension of the experimental protocol or ability to provide consent.

Hemineglect

Cerebellar lesions or on cerebellar pathways

Contact precautions
Blood Lipid-lowering Effect of Brown Alga Ecklonia Cava

The investigators performed a 12-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Ecklonia cava extract on hyperlipidemia.

The investigators performed a 12-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of Ecklonia cava extract on hyperlipidemia. The investigators measured improvement of lipid profile, including total cholesterol, triglyceride, HDL-cholesterol, and LDL-cholesterol.

Eligibility Criteria:
Inclusion Criteria:

* Mild hypercholesterolemic subjects(≥200mg/dL of total cholesterol or ≥110mg/dL of LDL-cholesterol)

Exclusion Criteria:

* Self-reported pregnancy, lactation
* Prevalent heart disease, cancer, renal disorder, or diabetes mellitus, and use of lipid-lowering drugs
Effect of Latanoprost on Optic Nerve Perfusion

46 eyes of 23 patients have been treated with topical Latanoprost 0.005 %. visual field was performed on all eyes. NFLT was measured using OCT. Radial peripapillary capillary (RPC) vascular density was measured using OCTA . mean ocular perfusion pressure (MOPP), and RPC vascular density were measured before and after treatment BY 2-3 MONTHS

All patients had bilateral primary open angle glaucoma diagnosed by increased IOP, visual field changes, and defective nerve fiber layer thickness (NFLT) on OCT examination.

All patients treated with topical Latanoprost 0.005% (XalatanTM, 2.5 ml eye drops, Pfizer) Inclusion criteria: age \&gt; 20 years, newly diagnosed patients with POAG. The exclusion criteria included optic nerve lesions other than glaucomatous changes, All patients completed their ophthalmic examination to detect BCVA, cycloplegic refraction, and anterior segment examination , IOP measuring by applanation tonometer, and indirect ophthalmoscope fundus examination.

Visual field testing. The thickness of NFL around the disc was evaluated using spectral domain optical coherence tomography (OCT) Optovue octa was used to quantify the density of the radial peripapillary capillary (RPC) vessels. This study employed software to quantify the capillary (microvasculature) density in both the entire image and in the peripapillary region specifically the superior, nasal, inferior, and temporal quadrants.

The mean arterial blood pressure (MAP) was determined by adding the diastolic blood pressure (DBP) to one third of the difference between systolic blood pressure and the diastolic blood pressure.

All eyes were treated with topical latanoprost 0.005% (XalatanTM, 2.5 ml eye drops, Pfizer) with dose of one drop at bedtime. IOP, MOPP, NFLT, and RPC vascular density were measured before the beginning of treatment and 1 and 3 months after treatment.

Eligibility Criteria:
Inclusion Criteria:

POAG with no past ocular surgery or laser retinal treatment. No previous anti-glaucoma medications

Exclusion Criteria:

* optic nerve lesions other than glaucoma
Resolvin D1 Levels in Patients With Periodontitis

The purpose of the study was to determine the levels of Resolvin D1 (RVD1) in the gingival crevicular fluid (GCF) and saliva of the patients with periodontitis (P) and also to investigate the effects of non-surgical periodontal treatments (NSPTs) on its levels.

A total of 26 subjects (15 P, 11 healthy) were included. Clinical periodontal measurements, GCF and saliva samples were collected from each individual at baseline and 1 month after NSPTs in P group. RVD1 levels were determined by enzyme-linked immunosorbent assay (ELISA) method.


Eligibility Criteria:
Inclusion Criteria:

* Stage 3, Grade B and generalized periodontitis patients

Exclusion Criteria:

* excessive forces;
* presence of systemic diseases
* administration of non-steroidal and anti-inflammatory drugs or antibiotic therapies within the previous 6 months
* having received non-surgical periodontal treatment within the past 6 months
* allergy or sensitivity to any drug,
* pregnancy, lactation
* current and former use of tobacco.
Decision Making in End of Life as Individual Preferences

It is not universal that terminally ill patients choose surrogate in the event of disagreement between the treating physician and the surrogate at the end of their lives. There are several factors that influence the terminally ill patient's decision to choose a decision maker at the end of his / life.

The right of the patient to exercise autonomy, whether to accept the recommendation of physician is not lost when the patient is unable to make health related decision. This is the basis of substituted judgment. Without written advance directives, a surrogate has to be assigned using relevant state relationship hierarchy, and usually a family member serves as a surrogate when the patient no longer has capacity to make medical decisions. Several studies showed that surrogates do not predict the patients preference accurately when both are asked to respond to hypothetical questions. Patient designated hierarchy predicted the patient treatment preferences with 69% accuracy whereas legally assigned proxy was accurate in 68%. Even the prior discussion of the treatment preferences did not seem to improve the surrogate accuracy. Surrogates make errors predicting patient's preferences in different directions, as was found in several studies. Three studies have found that surrogates err by providing intervention that patients do not want, while others found no specific trends. Other studies showed physicians to be less accurate than surrogates in predicting the patient's wishes.

Some studies have shown that patients want their surrogates to make decision for them when there is disagreement between the patient's wishes and his or her surrogate. No studies have looked at patients preferences when there is conflict between the surrogate and the physician.

To choose the right surrogate is a paramount. One way to do this is to analyze the patient's trends as to 'how' and 'why' patients choose his or her surrogates. Little is known about what factors influence the patients' decisions to choose the surrogate and what would be their decision in the event of disagreement between the treating physician and the surrogate. Factors such as patient's culture, ethnic or religious background may play an important role in patients' preferences at the end of their lives.

The investigators aim to assess terminally ill patients' decision making preferences at the end of life and identify specific factors that determine their preferences.

Eligibility Criteria:
Inclusion Criteria:

1. Non-resectable malignancy undergoing palliative care treatment
2. Severe end stage COPD with FEV1 \< 30% and receiving home O2 for \> six months
3. End stage cardiomyopathy NYHA class III/IV, not candidate for heart transplantation.

Exclusion Criteria:

* None
Phase 2 Study With Cis-UCA Ophthalmic Solutions in Subjects With Dry Eye

The objective of the Phase 2 study is to compare the safety and efficacy of cis-UCA Ophthalmic Solutions to placebo for the treatment of the signs and symptoms of dry eye.


Eligibility Criteria:
Key Inclusion Criteria:

* Be at least 18 years of age;
* Provide written informed consent;
* Have a subject reported history of dry eye;
* Have a history of use or desire to use eye drops.

Key Exclusion Criteria:

* Have any clinically significant eye findings that require therapeutic treatment, and/or in the opinion of the Investigator may interfere with study parameters;
* Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study;
* Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months;
* Have used Restasis® within 30 days of Visit 1;
* Have any planned ocular and/or lid surgeries over the study period;
* Be a woman who is pregnant, nursing or planning a pregnancy;
* Be unwilling to submit a urine pregnancy test at Visit 1 and Visit 4 (or early termination visit) if of childbearing potential;
* Have a known allergy and/or sensitivity to the study drug or its components;
* Have a condition or be in a situation which the Investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study;
* Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 30 days of Visit 1;
* Be unable or unwilling to follow instructions, including participation in all study assessments and visits.