cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Iontophoresis-assisted AFL-PDT in Actinic Keratosis

Iontophoresis is a transdermal drug-delivery technique that enhances the transport of ionic species across membranes and may have significant benefit for the treatment of actinic keratosis (AK) by ablative fractional laser-primed photodynamic therapy (AFL-PDT).

Photodynamic therapy (PDT) with methyl-aminolevulinate (MAL) is effective in the treatment of actinic keratosis (AK). Many strategies have been studied to improve the production of protoporphyrin IX (PpIX), to improve efficacy of PDT. Pre-treatment of the skin with fractional laser resurfacing is a novel alternative technique to improve the efficacy of PDT for AK. Our previous studies showed that ablative fractional laser-primed PDT (AFL-PDT) offered higher efficacy than conventional MAL-PDT in the treatment of many diseases, such as AK, actinic cheilitis, Bowen's disease and basal cell carcinoma.1-4 Iontophoresis can be another method to improve efficacy of PDT. Iontophoresis is a transdermal drug-delivery technique which uses a mild electric current to enhance the transport of ionic species across membranes. Iontophoresis has been widely used to enhance drug delivery. Mizutani K et al.5 reported 5 AK patients successfully treated with direct-current pulsed iontophoresis-assisted 5-aminolevulinic acid (ALA)-PDT. Boddé HE et al.6 studied iontophoretic transport of ALA quantitatively in vitro and demonstrated enhanced transport of ALA by iontophoresis.

Until now, appropriate incubation time for AFL-PDT has not been elucidated. In our previous study, we investigated the efficacy of AFL-PDT with a short incubation time.7 Although AFL-PDT with a short incubation time (2 h) showed enhanced efficacy than conventional MAL-PDT with the standard incubation time, standard AFL-PDT with 3-h incubation time showed significantly higher efficacy than AFL-PDT with a short incubation time.

The aim of our study was to evaluate efficacy of iontophoresis in AFL-PDT for AK treatment. Consequently, we compared efficacy, recurrence rate, cosmetic outcome and safety between iontophoresis-assisted AFL-PDT with 2-h incubation time and conventional AFL-PDT with 2-h and 3-h incubation times.

Eligibility Criteria:
Inclusion Criteria:

* Korean patients aged ≥ 18 years who had biopsy-confirmed AK lesions

Exclusion Criteria:

* lactating or pregnant women
* patients with porphyria or a known allergy to any of the constituents of the MAL cream and lidocaine
* patients with systemic disease, history of malignant melanoma, tendency of melasma development or keloid formation, any AK treatment of the area in the previous 4 weeks, or any conditions associated with a risk of poor protocol compliance; and patients on immunosuppressive treatment
* metal-containing device (cardiac pacemaker, orthopaedic implants, gynaecological devices)
* cardiac arrhythmia
* large skin erosion
Ultrasonography vs Cole Formula to Predict Endotracheal Tube Diameter

This study aims to compare the accuracy of measurement between ultrasonography and Cole formula in predicting uncuffed endotracheal tube diameter.

Approval from Ethical Committee of Faculty of Medicine Universitas Indonesia was acquired prior conducting the study. Subjects were given informed consent before enrolling the study. Non-invasive blood pressure (NIBP) monitor, ECG and pulse-oximeter was set on the subjects in the operation room. The uncuffed endotracheal tube (ETT) diameter predictions were measured firstly using ultrasonography (USG), then with Cole formula. After that, polyvinyl chloride (Mallinckrodt) ETT intubation with Cole diameter measurement was inserted using direct laryngoscopy. If the ETT was too small, use a 0.5 mm bigger ETT than the prediction diameter, if it too big, use a 0.5 mm smaller ETT than the prediction diameter. Reintubation and measurements using both methods were recorded. If bradycardia or desaturation happened, positive pressure ventilation, 100% oxygen, atropine 0,01-0,02 mg/kg, adrenaline 0,01 mg/kg could be given. Data was analyzed using SPSS using Bivariat Chi-square test or Fisher Exact Test (categorical comparative analytical study).

Eligibility Criteria:
Inclusion Criteria:

* Subjects aged 1-6 years old, Malayan race, planned to undergo elective surgery with general anesthesia with intubation
* Subjects with ASA status I-II
* Cooperative subjects
* Subjects whose parents had signed the informed consent

Exclusion Criteria:

* Subjects with allergies to Ultrasonography jelly
* Subjects with difficult airway
* Subjects with mass in the neck area
* Subjects with respiratory diseases
* Subjects with growth \& development disorders
* Subjects with malnutrition (\<5% percentile) and obesity (\>95% percentile).

Drop out criteria:

* Subjects with cardiorespiratory disorder during intubation
* Subjects who were failed to be intubated twice.
Ultrasound-guided Thermal Ablation for Papillary Thyroid Carcinoma

To evaluate long-term outcomes of ultrasound-guided thermal ablation for the treatment of papillary thyroid carcinoma

To evaluate and predict long-term clinical outcomes of ultrasound-guided thermal ablation for the treatment of papillary thyroid carcinoma by a multicenter study

Eligibility Criteria:
Inclusion Criteria:

1. patients age between 18 and 80 year old, both sex
2. papillary thyroid carcinoma confirmed by core-needle biopsy or fine-needle aspiration
3. the largest diameter ≤2.0 cm
4. no clinical or imaging evidences of extrathyroidal extension, lymph node metastasis and distant metastasis on ultrasound, neck and chest CT
5. follow-up period ≥12 months

Exclusion Criteria:

1. patients with convincing evidence of aggressive papillary thyroid carcinoma or other type of thyroid cancer by biopsy
2. history of neck radiation
3. coagulation disorder, serious heart, respiratory, liver, or renal failure
4. dysfunction of the vocal cord on the opposite side
Genetic Variation in OCT1 and Response to Metformin

Type 2 diabetes its microvascular and macrovascular complications have become a major global health problem. Metformin is often used as first-line therapy for this disorder given that it is cheap, may cause weight loss and does not have significant side-effects in healthy patients. On the other hand, as many as one third of all patients with type 2 diabetes initially treated with metformin never achieve a meaningful response to this intervention. Recently, genetic variation in the organic cation transporter 1 (Oct1) gene which encodes a protein, OCT1, mediating metformin uptake by the liver, its primary site of action, has been shown alter metformin action. In Oct1-deficient mice the glucose-lowering effects of metformin are completely abolished. Moreover a polymorphism with a 20% minor allele frequency in Caucasians also alters the effect of metformin on glucose tolerance (the net result of glucose uptake and glucose release) after ingestion of 75g of glucose. However, it is unknown if this polymorphism affects suppression of endogenous glucose production or stimulation of peripheral glucose uptake by metformin, or both, and to what degree. We propose to utilize established methodology to measure glucose turnover in response to a mixed meal to determine how common genetic variation in OCT1 alters response to metformin in healthy volunteers. This will clarify the effect of these variants on response to metformin in humans. The knowledge gained from this study will help to design future studies examining the role of OCT1 genotype in determining initial therapy for type 2 diabetes.


Eligibility Criteria:
Inclusion criteria: -

1. Heterozygous or homozygous for the nsSNPs R61C, G401S, 420Del, G465R, G174S (see supplementary info (3)) or without any nsSNPs that could potentially alter gene function.
2. Age 18 - 40.
3. Willingness to participate in this study.

Exclusion criteria: -

1. Fasting glucose \> 100mg/dL on one occasion.
2. Use of medication other than stable thyroid hormone replacement or oral contraception.
3. Subjects must not be pregnant or \< 6 months postpartum at the time of study.
4. Prior abdominal surgery other than hysterectomy, appendectomy or tubal ligation.
Tailored Internet Information Supply for Patients

Medical expert systems in combination with portal searching meta-search engines are exploited to provide reliable patient-tailored information. A prototype of a web-based information system has been developed and is to be evaluated. Its aim is to answer the decisive question whether expert system guided internet meta-search provides a better information supply for patients seeking health information online then this is possible by using ordinary search engines or health portals. The research does neither investigate the influence of ethical nor legal aspects of internet health information supply.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 75
* Suffers at least occasionally from headaches
* Has internet access
* Has not obtained a medical diagnosis (concerning this headache) by a physician, yet

Exclusion Criteria:

* Age under 18
* Age over 75
* Does never suffer from headaches
* Has no internet access
* Has already gotten a medical diagnosis for her/his headaches
Bioequivalence Study of Revolade® Eltrombopag 50 Mg

Bioequivalence Study

A bioequivalence study of Eltrombopag will be developed in 30 healthy subjects, under fasting condition, following the design:

Open-label, crossover, randomized, single-dose design of 50 mg Eltrombopag tablets/immediate release tablets, with two treatments, two periods, two sequences in healthy volunteers in fasting condition, with a washout time of 15 days between each dose

Eligibility Criteria:
Inclusion Criteria:

* Women and men between 18 and 50 years of age. Have been clinically diagnosed as healthy by the trial physician. Subjects with clinical laboratory results requested in the protocol (Table 2) within normal ranges and/or fit by medical screening. Current for 3 months.

Subjects non-smokers for the last 3 months. Having signed the informed consent. Subjects sexually active or of reproductive age must use an effective contraceptive method during and for at least 7 days after the end of the study.

Body mass index between 18-30 kg/m2 at the time of inclusion in the study. Subject with complete contact information (cell phone and/or landline contact, address, email).

Subject who has a family member or guardian with a contact telephone number. Subject with the availability of time to comply with the scheduled visits and activities.

Exclusion Criteria:

* Subject with a diagnosis of renal, cardiac, hepatic, immunological, dermatological, endocrine, gastrointestinal, neurological or psychiatric disease.

Woman in a state of pregnancy or breastfeeding. Subject diagnosed with hematological disorders, such as anemias and/or polycythemia.

Subjects with a history of gastric surgeries. Permanent or temporary use during the last 15 days of any type of medication either on their own initiative or by medical prescription. Except female patients who are planning regularly with the same contraceptive method in the last 6 months prior to the start of the present trial.

Consumption of xanthines from coffee, tea or chocolate during the 48 hours prior to hospitalization.

Drinking alcohol in excess of 16 grams every week equivalent to 1 beer or 2 glasses of wine during the last 15 days prior to hospitalization.

Consumption of drugs of abuse or psychoactive substances reported as positive test at the time of hospitalization.

Known hypersensitivity to the active ingredient or excipients of the test product.

Medical history of angioedema or anaphylaxis. Subject diagnosed with human immunodeficiency virus infection, hepatitis B or hepatitis C positive.

Having participated in clinical studies in the 4 months prior to the time of signing the informed consent.

Having donated blood in the 30 days prior to the time of signing the informed consent.
Mental Health in Veterans and Families After Group Therapies

PTSD (posttraumatic stress disorder) and associated mental health conditions affect both veterans and their family members. This study investigates whether group therapy using EFT (Emotional Freedom Techniques) and CBT (Cognitive Behavior Therapy) produce reductions in PTSD and comorbid symptoms.


Eligibility Criteria:
Inclusion Criteria:

* The ability to follow instructions, complete written forms, and provide informed consent. Subjects are required to be literate and understand English.
* Physically healthy.
* Active duty military service, veterans, and their family members.

Exclusion Criteria:

* None
Chewing and Swallowing Training Program in Coffin-Lowry Syndrome

This study will report the chewing and swallowing disorders of a Coffin-Lowry Syndrome (CLS) patient, and effects of chewing and swallowing training on chewing and swallowing function.

Patients with CLS suffer from spinal deformities, nonconvulsive status epilepticus, obstructive sleeep apnea syndrome, pneumonia, stimulus-induced myoclonus, cases of falls, mechanical ventilation, restrictive lung disease. It was also reported that patients with CLS had problems with eating and feeding functions. However there is no study investigating chewing and swallowing functions of this patient population. Therefore, the investigators have three main purposes:

1. To chewing and swallowing function in a boy with CLS diagnosis who was referred due to coughing during eating, long-lasting wheezing, sputum and inability to intake solid food
2. To investigate the effects of two months of chewing and swallowing training program
3. To present long term follow-up effects on chewing and swallowing function.

Eligibility Criteria:
Inclusion Criteria:

* Having a diagnosis of CLS
* Having a history of coughing during eating, long-lasting wheezing, sputum
* Inability to intake solid food.

Exclusion Criteria:

- No history of coughing during eating, long-lasting wheezing, sputum
ASHCOM Shoulder System and Its Related Instruments

The objectives of this study are to confirm safety, performance and clinical benefits of the ASHCOM Shoulder System and its related instruments by analysis of standard scoring systems, radiographs and adverse event records.

This study is a multicenter, prospective, non-controlled Post-Market Clinical Follow-up study involving orthopaedic surgeons skilled in reverse shoulder arthroplasty procedures. A minimum of three study centers will be involved. A total number of 97 implants will be included into the study.

The primary endpoint is defined by the survival of the implant at 10 years which is based on removal or intended removal of the prosthesis and will be determined using Kaplan Meier method. The safety of the system will be assessed by monitoring the frequency and incidence of adverse events.

The secondary endpoint is defined by the performance and clinical benefits of the ASHCOM Shoulder System at 5 years, which is assessed by the Constant and Murley score. Assessments of the overall pain, functional performance, survival, quality of life and radiographic parameters of all enrolled study subjects will be evaluated in addition.

Eligibility Criteria:
Inclusion Criteria:

* Patient is capable of understanding the doctor's explanations, following his instructions and is able to participate in the follow-up program.
* Patient has given written consent to take part in the study by signing the "Patient Consent Form".
* Patient is 18-80 years of age, inclusive.
* Patient is skeletally mature.
* Patient requires a primary, fracture or revision reverse total shoulder replacement for the relief of pain and has significant disability due to gross rotator cuff deficiency.
* Patient's joint is anatomically and structurally suited to receive the selected implants.
* Patient has a functional deltoid muscle.

Exclusion Criteria:

* Patient is unwilling or unable to give consent or to comply with the follow-up program.
* Patients who have any condition which would in the judgement of the Investigator place the patient at undue risk or interfere with the study. Any patient who is institutionalized, or is a known drug abuser, a known alcoholic or anyone who cannot understand what is required of them.
* Patient is known to be pregnant or breastfeeding.
* Patient is a vulnerable subject.
* Patient meets at least one of the contraindications:

  * Signs of infection
  * Significant injury to the upper brachial plexus
  * Non-functional deltoid muscle
  * Insufficient quality and/or quantity of glenoid or humeral bone
  * Any neuromuscular or vascular disease compromising the affected limb that would endanger the success of the intervention
A Clinical Trial Assessing the Impact of the Availability of Inhaled Insulin on Glucose Control

To assess the impact on glucose control by inhaled insulin in patients with type 2 diabetes who are not well controlled on 2 or more oral anti-diabetic agents


Eligibility Criteria:
Inclusion Criteria:

* Diabetes mellitus Type 2
* Failing two or more oral anti-diabetic agents

Exclusion Criteria:

* Asthma, COPD
* Smoking
Biorepository of Biomarkers for Optimization of Microvascular Treatment of Lymphedema

Researchers are collecting information, saliva, blood and tissue from subjects with lymphedema to store for future research.


Eligibility Criteria:
Inclusion Criteria:

* Adult (18+ years of age)
* Ability to provide written consent
* Has been diagnosed with Lymphedema

Exclusion Criteria:

* Under the age of 18 years old
* Inability to provide written consent
* Previous lymphovenous bypass or lymph node transfer surgery
* Major changes occur to co-morbid conditions
* Proven ICG or iodine allergy
Pain Control and Subconjunctival Hemorrhage Size After Intravitreal Injection

Intravitreal injections (IVI) are the mainstay of treatment modality in many ophthalmologic diseases including neovascular age-related macular degeneration (AMD), diabetic retinopathy and retinal vascular occlusions. Patients endure monthly IVI for several years. Although standardized topical anesthesia protocols are being carried out, many still suffer from pain during and after the procedure. Previous studies at the investigators clinic have demonstrated that alpha-agonist eye drops and cool eye compresses can be successfully used in order to reduce pain levels when administered prior to IVI. In the current research, the investigators wish to study whether cooled anesthetic eye drops and antiseptics can be utilized as well to reduce the pain and subconjunctival hemorrhage caused by bevacizumab IVI.


Eligibility Criteria:
Inclusion Criteria:

* Participants over the age of 18 years, receiving Bevacizumab IVI who are capable of signing a written informed consent form obtained under the Declaration of Helsinki.

Exclusion Criteria:

* No consent to participate in the study.
* Incapability of signing a written informed consent form.
Comparison of Topical and Nebulized Anesthesia in Patients Undergoing Esophago-Gastro-Duodenoscopy

This study compares the effect of nebulized lidocaine and lidocaine spray in patients undergoing esophago-gastro-duodenoscopy. The investigators evaluate the success rate of the procedure between two methods.

This is a randomized-controlled trial in the patients undergoing esophago-gastro-duodenoscopy. The patients are randomized by computer into two arms: nebulized lidocaine and lidocaine spray. Both drugs are applied 15-20 minutes prior the prior the procedure. Only one endoscopist participate in this study. After the procedure finishes, the investigators evaluate the outcome and satisfaction of patients and endoscopist.

Eligibility Criteria:
Inclusion Criteria:

* elective case for esophago-gastro-duodenoscopy with ASA classification 1-2
* Both genders
* Age between 18-65 years

Exclusion Criteria:

* History of smoking
* Upper respiratory tract infection
* Asthma
* Heart disease
* Allergy to local anesthetic drugs

Withdrawal or termination criteria

* Patient refusal
* Patient develops lidocaine allergy
* Bronchospasm
* Sign of Local Anesthetic Toxicity
Perform Necrotic Cavity Lavage or Not After Debridement of Infected Pancreatic Necrosis

The infected pancreatic necrosis (IPN) should be treated by debridement and drainage. In recent years, the results of clinical research show that minimally invasive debridement such as video-assisted (laparoscope, nephroscope, endoscopy, etc.) and total laparoscopic debridement can significantly improve the prognosis of IPN patients. After a long period of clinical practice, laparoscope-assisted debridement was selected as the main surgical method in our center. In many large-scale clinical studies, patients after surgery underwent necrotic cavity lavage (such as small omental sac lavage, retroperitoneal space lavage, peripancreatic lavage, etc.), but its necessity and clinical significance were not clearly stated in the guidelines. At present, the clinical research mainly focuses on the improvement of minimally invasive debridement, and less on the necessity of lavage. In the past, necrotic cavity lavage was performed in IPN patients, but long-term clinical observation showed that lavage may lead to spread of infection and increase the incidence of lower extremity venous thrombosis which is not accorded with ERAS(Enhanced Recovery After Surgery). Therefore, since 2012, our center has stopped necrotic cavity lavage for IPN patients after debridement. We retrospectively analyzed the therapeutic effect from February 2014 to August 2017 and found that even without necrotic cavity lavage, better therapeutic effect could be achieved. Meanwhile it can simplify the operation process and avoid infection spread. This treatment method provides a new idea. However, it is a retrospective study not a randomized controlled trials(RCT) which is low effectiveness of proof. Therefore, we design this RCT to verify the necessity of necrotic cavity lavage after laparoscope-assisted debridement for patients with infected pancreatic necrosis.


Eligibility Criteria:
Inclusion Criteria:

1. diagnosis of IPN
2. onset time of \>4 weeks
3. performance of LAD for IPN
4. provision of written informed consent

Exclusion Criteria:

1. the highest temperature in 24 hours of ≥38.5ºC
2. new organ failure occurring within 24 hours after the operation
3. digestive tract fistula, biliary tract or digestive tract obstruction, or bleeding occurring within 24 hours after the operation
4. abdominal pressure of ≥10 mmHg within 24 hours after the operation
5. traumatic pancreatitis or a pancreatic fistula-related infection after the pancreatic operation