cyrilzakka/clinical-trials huggingface dataset:
Ultraviolet and UV-Visible Light Photoprotection for the Treatment of Melasma

Melasma is an acquired discoloration of the skin characterized by brown colour changes commonly on the face. The duration of this double-blind clinical trial will be 12 weeks. The control group will receive treatment with topical Hydroquinone (4%) and a Broad spectrum UV sunscreen. The experimental group, 4% topical hydroquinone and a Broad spectrum UV-visible light sunscreen. Visible light has melanotic properties and avoiding it can be part of the treatment for melasma patients. The estimated number of subjects to be recruited and randomized for the study is at least 25 per group. The purpose of this study is determine if there is a difference in the improvement between these two sunscreens types. Melasma Area and Severity Index (MASI) score will be assessed at the beginning of the study and at weeks 4, 8, and 12. Photographs, colorimetry and histological assessment will be also evaluated. Occurrence of adverse effects will also be recorded.

Melasma is a common acquired hypermelanosis in dark skin populations, usually characterized by symmetrical, irregular macules occurring in photo-exposed areas such as face. Treatment with sunscreens and depigmenting compounds such as hydroquinone, are still the gold standard in this condition.

Visible light has pigmenting properties that could be interfering with the treatment in melasma patients. So, the primary objective of this study is to compare the depigmenting adjuvant effect of using a UV-visible blocking sunscreen against a UV sunscreen.

Patients who are included in the study will be randomly assigned to receive one of the sunscreen type, which should use for 12 weeks. The sun blocking agents should be applied in the affected regions every 3 hours from 8AM to 5PM. The evaluation of clinical improvement will be done in a blinded modality by means of the MASI score, the Global Physician Assessment, as well as colorimetry and histological melanin content. Evaluations will be held on visits at 4, 8 and 12 weeks. Skin biopsy will be taken at onset and at 12 weeks.

At the end of the study, data will be compared concerning the former parameters. All side effects will be recorded and analysed.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Women over 25 years of age
* Dermatologic diagnostic of melasma
* Phototype III or more

Exclusion Criteria:

* Pregnant or breastfeeding
* Postbirth, abortion in the past 6 months
* Having an endocrine or autoimmune disease
* Under hormonal therapy of any kind including contraceptives or it´s use in the past 6 months
* Currently under treatment for melasma including sunscreens
* Currently under radiation therapy, chemotherapy, immunosuppressants of any kind or phototherapy or it´s use in the past 6 months
* Having used or are consuming photosensitizing substances, oral or topical
Repeat Doses Of A New Medication (GW642444) In Asthmatic Patients

In order to obtain information on a wider range of doses of GW642444 (a possible new medication to treat asthma) than has been previously examined in asthmatic patients, this current study will be conducted at doses of 25 100 and 400 mcg of GW642444 and will be compared with salmeterol (50 mcg twice daily). This study will be conducted in a similar manner to a study that has already been completed (study number B2C101762) which examined repeat doses of 50, 100 and 200 mcg of GW642444. The data obtained will compliment the data from study B2C101762 and will provide confidence (or not) that the desired bronchodilation can be achieved and maintained without undesirable side effects.


Eligibility Criteria:
Inclusion criteria:

* Subjects with a documented history of persistent asthma.
* Current non-smokers.
* Clinically stable persistent asthma FEV1 between 60 and 90% of predicted values.
* Inhaled corticosteroid therapy at a total daily dose between 200-500mcg of fluticasone or equivalent.

Exclusion criteria:

* Subjects with significant past or present disease which which may affect their safety.
* Upper or lower respiratory tract infection within 4 weeks of screening.
* History of life threatening asthma, or asthma requiring treatment with oral corticosteroids within 3 months of study.
* Patients taking doses of inhaled corticosteroid \>500mcg/day and patients who have changed therapy within 8 weeks of the study.
* Patients weighing less than 50kg.
A Study of MK2206 in Locally Advanced or Metastatic Solid Tumors (2206-007)

This study is designed to evaluate the safety and tolerability, pharmacokinetics, pharmacodynamics and anti-tumor activity of MK2206 when administered with Every Other Day (QOD) and Once Weekly (QW) dosing schedules.


Eligibility Criteria:
Inclusion Criteria:

* Patient must have confirmed locally advanced or metastatic solid tumors that have failed to respond to standard therapy, have gotten worse or have come back after existing therapy
* Has adequate organ function
* Is ECOG Performance Scale 0-1
* Has a negative urine pregnancy test if patient is female
* Is able to swallow capsules and has no surgical or bodily condition that will prevent the patient from swallowing and absorbing oral medications on an ongoing basis

Exclusion Criteria:

* Patient has had chemotherapy, radiotherapy, biological therapy or surgery within 4 weeks of starting the study and has not recovered from adverse events caused by the treatment
* Is currently participating or has participated in a study with an investigational compound or device within 28 days
* Has a primary central nervous system tumor
* Has a history or current evidence of heart disease, slow heart rate or untreated high blood pressure
* Is a known diabetic who is taking insulin or oral antidiabetic therapy
* Is pregnant or breastfeeding or planning to become pregnant during the study
* Is positive HIV antibody, HBs antigen or HCV antibody
The Analysis of Gene Variants Related to POCD in Elderly Patients

The pathophysiology of postoperative cognitive dysfunction (POCD) following surgery may be related to Alzheimer's disease. Different studies show that; low levels of glial cell line-derived growth factor are found in both POCD and Alzheimer, and brain cholinergic markers like Choline acetyl transferase activity, High affinity choline uptake activity, and Acetil Choline (Ach) activity are decreased in Alzheimer disease.We know cholinergic inputs in the basal forebrain have a critical role in many other functions including memory, attention, arousal and sensory processing.

Cholinergic neuron located basal section of forebrain degenerate extensively in Alzheimer disease which shares similarities with postoperative delirium and POCD. Ach binds to two well-known receptors in brain that are Nicotinic receptors which implicate several important functions such as "memory, learning, arousal and reward" and Muscarinic receptors which are widely distributed in forebrain and play an important role of development delirium and POCD. Dysfunction of cholinergic system may be one key aspect of postoperative DELIRIUM, POCD and ALZHEIMER disease.

In this investigation; we would like to evaluate the relationship between genes encoding inflammation-related mediators detected in postoperative cognitive dysfunction and gene variants in Alzheimer's disease in a larger panel for elder patients undergoing major urologic surgery. Therefore our study will focus on demographic information of the patients (age, gender, comorbidity), neurocognitive tests (1 week before the surgery, postoperative 1st week and postoperative 3rd month), intraoperative data (mean arterial pressure, heart rate, need for inotrope, duration of mechanical ventilation, need for transfusion), and biochemical tests (Preoperative and postoperative blood samples for each patient) which are APOE, phosphatidylinositol-binding clathrin assembly protein, CR1 - complement receptor 1, ATP-binding cassette transporter, IL6, TREM.


Eligibility Criteria:
Inclusion Criteria:

* Patients over age of 60 years
* Patients scheduled for major urologic surgery

Exclusion Criteria:

* Failure of the patient or the person with legal authority to make a decision about him/her.
* Patients with severe hearing-vision problems before surgery.
* Patients with severe neurological-psychiatric disorders before surgery.
* Patients who cannot find a common language.
* Emergency surgeries
Pressure Support Ventilation Versus Neurally Adjusted Ventilatory Assist in Difficult to Wean Pediatric Patients

This study assessed the effects of NAVA versus Pressure Support Ventilation (PSV) on patient-ventilator interaction in pediatric patients with difficult weaning from mechanical ventilation after moderate Pediatric Acute Respiratory Distress Syndrome (PARDS).

12 pediatric patients, admitted in Pediatric Intensive Care Unit (PICU) with moderate PARDS and who failed up to 3 SBTs in less than 7 days, were enrolled in this study. These patients underwent three studies conditions, lasting 1 hour each: Pressure support ventilation 1, Neurally adjusted ventilatory assist and Pressure support ventilation 2.

During each trial were recorded the patient tracings of flow, airway pressure and electrical activity of diaphragm for the patient-ventilator interaction analysis.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of moderate PARDS
* 3 spontaneous breathing trials failed in less than 7 days

Exclusion Criteria:

* hemodynamic instability
* severe respiratory instability
* contraindication to nasogastric tube exchange
* increase in intracranial pressure
* palliative care for end-stage oncologic disease
* neuromuscular disease
* lesions of medulla
Cirrhosis Registry of Hospitalized Patients

Cirrhosis registry of consecutive adult consenting patients hospitalized with liver cirrhosis in the tertiary liver unit

On admission to F.D.Roosevelt Teaching Hospital / HEGITO Liver Unit (Div Hepatology, Gastroenterology and Liver Transplant), all the adult patients with liver cirrhosis are offered to participate.

After providing informed consent, their demographic, clinical and laboratory / imaging data are uploaded by dedicated study person After discharge from the hospital, follow-up is recommended and uploaded to RH7 (if the follow-up visits take place at this institution \[FDR\]) Mortality data are uploaded from the national registry of dead on regular basis

Eligibility Criteria:
Inclusion Criteria:

* liver cirrhosis (primarily on clinical grounds)
* decompensating event leading to hospital admission
* informed consent

Exclusion Criteria:

* declined consent
Wide Field OCT + AI for Positive Margin Rates in Breast Conservation Surgery.

This is a multi-center, randomized, two-arm study designed to measure the effectiveness of the SELENE system in reducing the number of unaddressed positive margins in breast lumpectomy procedures when used in addition to standard intraoperative margin assessment.


Eligibility Criteria:
Inclusion Criteria:

* Female
* Age 18 years or older
* Patients undergoing elective breast conservation surgery for the treatment of Stage 0-III invasive ductal and/or ductal carcinoma in situ
* May include subjects treated with neo-adjuvant therapy (endocrine and/or chemotherapeutic), but not required for study inclusion
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Male
* Metastatic cancer (Stage IV)
* Lobular carcinoma as primary diagnosis
* Previous ipsilateral breast surgery for benign or malignant disease within two years (this includes implants and breast augmentation)
* Subjects with multi-centric disease (histologically diagnosed cancer in two different quadrants of the breast), unless resected in a single specimen
* Subjects with bilateral disease (diagnosed cancer in both breasts)
* Participating in any other investigational margin assessment study which can influence collection of valid data under this study
* Use of cryo-assisted localization
* Currently lactating
* Current pregnancy
* Subjects for whom the specimen margins have been destroyed, damaged, or are otherwise not intact prior to imaging (device arm only) imaging
Indirect Laryngoscopy and Ultrasonography in Prediction of Difficult Airway

This study was designed to assess the success of indirect laryngoscopy and ultrasonographic measurements in the prediction of difficult airway. All patients were examined by indirect laryngoscopy and ultrasonography preoperatively and the predictive values for difficult airway of these methods were compared.

Difficult airway is a condition that increases the patient's vital risk and leaves the anesthesia and surgical team in a difficult position. Failure to perform an adequate preoperative evaluation may result in the team being unprepared. Therefore, various methods have been investigated in the prediction of difficult airway from past to present. With the development of technology, imaging methods have become routine applications in clinical use. Ultrasonography and indirect laryngoscopy have been shown to be used in predicting difficult airway in the literature, but there is no study showing which is a better predictor.

Eligibility Criteria:
Inclusion Criteria:

* Subject is operated in ear, nose and throat department.
* Subject over the age of 18.
* Subject giving consent to participate in the study.

Exclusion Criteria:

* Subject under the age of 18
* Subject with a history of radiotherapy in the head and neck region,
* Subject with facial deformity,
* Subject whose neck movements have been restricted by previous trauma or surgery,
* Subject has laryngeal disease
* Previously operated subject with known airway assessment
* Morbidly obese subject with BMI\> 40
Efficacy of an Augmented Reality Application Developed for ACLs Training on the Knowledge and Skill Levels of Nurses

Background: Having Advanced Cardiac Life Support (ACLs) skills is essential for nurses. During the COVID-19 pandemic, augmented reality (AR) technologies were incorporated into medical education to increase learning motivation and accessibility.

Objectives: To determine whether using augmented reality for educational applications can significantly improve first aid cart learning, learning motivation, cognitive load, and system usability among nurses in ACLs training of nurses.

Design: The present study was a quasi-experiment study. Settings: The research setting was a medical center in southern Taiwan Participants: In total, 102 nurses completed the course, with 43 nurses in the AR group and 59 nurses in the control group.

Methods: An ACLs cart training course was developed using augmented reality (AR) technologies in the first stage. However, the efficacy of the developed ACLs training course was evaluated.

Application Augmented Reality for ACLs training of Registered Nurse

Eligibility Criteria:
Inclusion Criteria: Nurses who were aged 20 years or older, could speak and read Mandarin, and completed the questionnaire after the research objective was explained were recruited.

Exclusion Criteria: Nurses without mobile devices were excluded.
A Study Comparing Amounts of Tafamidis (PF-06291826) in the Blood Without Food in Healthy Volunteers

3 different formulations and doses of tafamidis will be compared. Subjects will be fasted for each test and every subject will test all 3 different formulations. After swallowing tafamidis, tafamidis blood concentrations will be measured periodically for 8 days. After 14 days, subjects will take a different formulation of tafamidis and tafamidis blood concentrations will be measured periodically for 8 days. After another 14 days, the last formulation will be tested in the same way.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males or females of non-child bearing potential.
* Body Mass Index (BMI) of 17.5 to 30.5 and total body weight more than 50 kg (110 lbs).

Exclusion Criteria:

* Blood pressure at screening visit of greater than 140 mm Hg (systolic) or 90 mg Hg (diastolic).
* Use of prescription or nonprescription drugs supplements within 7 days prior to 7 days of the study.
* Pregnant female subjects; breastfeeding female subjects; male subjects with partners currently pregnant; male subjects able to father children who are unwilling or unable to use a highly effective method of contraception.
Value of Macrophage-Colony Stimulating Factor as a New Marker of Bone Lesions in Multiple Myeloma

The Primary objective of this study is to compare serum levels of Macrophage-Colony Stimulating Factor (M-CSF) in a population of patients with multiple myeloma (MM), in a population of patients with Monoclonal Gammopathy of Undetermined Significance (MGUS) and in a control population.


Eligibility Criteria:
Inclusion Criteria:

For the multiple myeloma group

* confirmed diagnosis of de novo multiple myeloma according to the International Myeloma Working Group criteria
* bisphosphonate therapy for more than 60 days,
* signature of the informed consent form,
* patients over the age of 18 years. For the monoclonal gammopathy of undetermined significance (MGUS) group
* confirmed diagnosis of MGUS according to the International Myeloma Working Group criteria
* signature of the informed consent form,
* patients over the age of 18 years. For the healthy control group
* signature of the informed consent form,
* subjects over the age of 18 years.

Exclusion Criteria:

* patients with thyroid or parathyroid disease,
* osteomalacia, rheumatoid arthritis, Paget's disease, osteoporosis,
* bisphosphonate therapy for less than 60 days,
* absence of informed consent,
* patients under the age of 18 years.
Effect of Training on Brain Volume in Ataxia

The primary aim is to show balance training improves DCD individual's ability to compensate for their activity limitations, but does not impact disease progression.

The second aim is to demonstrate aerobic exercise improves balance and gait in DCD persons by affecting brain processes and slowing cerebellar atrophy.

Individuals with degenerative cerebellar disease (DCD) exhibit gradual loss of coordination resulting in impaired balance, gait deviations, and severe, progressive disability. With no available disease-modifying medications, balance training is the primary treatment option to improve motor skills and functional performance. There is no evidence, however, that balance training impacts DCD at the tissue level.

Aerobic training, on the other hand, may modify DCD progression as evident from animal data. Compared to sedentary controls, aerobically trained DCD rats have enhanced lifespan, motor function, and cerebellar Purkinje cell survival. Numerous animal studies also document that aerobic training has a direct, favorable effect on the brain that includes production of neurotrophic hormones, enhancement of neuroplasticity mechanisms, and protection from neurotoxins.

The effects of aerobic training in humans with DCD are relatively unknown, despite these encouraging animal data. A single study to date has evaluated the benefits of aerobic exercise on DCD in humans, and this was a secondary outcome of the study. Although participants performed limited aerobic training during the study, modest functional benefits were still detected.

The main objective of this project will be to compare the benefits of aerobic versus balance training in DCD. We hypothesize that both aerobic and balance training will improve function in DCD subjects, but that the mechanisms in which these improvements occur differ. 1) Balance training improves DCD individual's ability to compensate for their activity limitations, but does not impact disease progression. 2) Aerobic exercise improves balance and gait in DCD persons by impacting the cerebellum

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with spinocerebellar ataxia

  * Cerebellar atrophy on MRI
  * Prevalence of ataxia on clinical exam
  * Ability to safely ride a stationary exercise bike

Exclusion Criteria:

* Other neurologic conditions • Heart disease

  * Cognitive impairment
  * Medical instability
The Study of the Antimicrobial Resistance of Helicobacter Pylori in Shandong Province

The antimicrobial resistance of helicobacter pylori in Shandong province was analyzed by helicobacter pylori antibiotic sensitivity test.And the map of antimicrobial resistance of helicobacter pylori was constructed to provide clinical guidance for selecting effective eradication program and improve the eradication rate.

The patients with positive H. pylori infection that was not eradicated by previous therapies will accept the gastroscopy. The mucosa of the lesser curvature of gastric antrum and the greater curvature of the stomach will progress helicobacter pylori antibiotic sensitivity test to detect the antimicrobial resistance of helicobacter pylori.The antimicrobial resistance of helicobacter pylori in Shandong province will be described by frequency and percentage.

Eligibility Criteria:
Inclusion Criteria:

* Patients, aged between 18 and 70 years old, with positive H. pylori infection that was not eradicated by previous therapies are included. The H. pylori infection is confirmed by the positive rapid urease test or 13C-breath test.

Exclusion Criteria:

* Patients with significant underlying disease including liver, cardiac, pulmonary, and renal diseases, neoplasia, coagulopathy and genetic diseases, history of gastric surgery, pregnancy, breast-feeding, active gastrointestinal bleeding, the use of PPI, NSAID or antibiotics during the 4 weeks prior to enrolment, and previous history of allergic reactions to any of the medications used in this protocol. Patients previously treated with H. pylori eradication regimens or those unwilling to participate in the study were also excluded.
Cognitive-Behavioral Therapy for Weight-related Bullying (Online Treatment)

This study will perform a clinical trial with adolescents to pilot a new cognitive-behavioral treatment (CBT) for weight-related bullying testing (1) feasibility, (2) acceptability, and (3) initial efficacy. The treatment will be conducted via audio/video telehealth.

Youth with obesity are more likely to be bullied than healthy-weight peers and weight-related bullying is the most common form of bullying. Treating bullying during childhood could reduce immediate and long-term health consequences, but there are no established individual-level treatments for weight-related bullying despite recommendations that they could improve children's health. This study will develop and test a new treatment for adolescents (11-17 years old) who have experienced bullying due to weight. The treatment will address traumatic stress and potentially co-occurring or developing problems with unhealthy weight-control behaviors, disordered eating, and weight. The treatment will be conducted via audio/video telehealth to increase accessibility and is therefore available to anyone in the United States who meets eligibility criteria.

Eligibility Criteria:
Inclusion Criteria: To be included, adolescents must:

1. Be in the age range ≥11 years old and ≤17 years old;
2. Report experiencing weight-related bullying
3. Report current distress about weight-related bullying
4. Be otherwise-healthy youth (i.e., no uncontrolled or serious medical conditions);
5. Read, comprehend, and write English at a sufficient level to complete study-related materials;
6. Located in the United States and available for participation in the study for 3 months.

Exclusion Criteria: Prospective participants will be excluded if the adolescent:

1. Has a medical or psychiatric condition that would require hospitalization or intensive care (e.g., severe anorexia, neurological disorder, psychotic disorders, suicidality);
2. Has uncontrolled medical condition(s) (e.g., uncontrolled diabetes or hypertension);
3. Is pregnant or breastfeeding;
4. Is taking medication(s) or participating in treatment(s) that could influence weight or appetite;
5. Is engaged in concurrent treatments that focus on trauma-related stress;
6. Began taking hormonal contraceptives less than 3 months prior;
7. Has a developmental or cognitive disorder (e.g., autism spectrum disorder);
8. Has avoidant/restrictive food intake disorder; or
9. Is participating in another clinical research study.