cyrilzakka/clinical-trials huggingface dataset:
Study of Pediatric Migraine: The Pediatric Migraine Registry

This is a multi-center registry that will prospectively collect regulatory compliant data from children and adolescents with migraine. This study will enroll approximately 200 participants from approximately 20 sites and will examine migraine symptoms, therapeutics used, and biomarkers associated with migraine.


Eligibility Criteria:
Inclusion Criteria:

* 4 to 17 years of age inclusive at the time of enrollment visit
* Meets International Classification of Headache Disorders, 3rd edition criteria for migraine with or without aura
* Guardian provides informed consent/HIPAA
* Participant provides assent if developmentally appropriate and required by the institutional review board

Exclusion Criteria:

* Any condition which would make the participant, in the opinion of the investigator, unsuitable for the study
Vitamin D Versus Placebo in the Treatment of Vague Musculoskeletal Pain in Children

Other studies suggest that low Vitamin D levels may contribute to musculoskeletal pain.

Hypothesis: Administration of oral Vitamin D supplements will improve vague musculoskeletal pain in children.


Eligibility Criteria:
Inclusion Criteria:

* ages 5-14
* healthy
* vague musculoskeletal pain without diagnosis

Exclusion Criteria:

* medications (steroids, seizure medications, birth control pills or shot)
* endocrinopathies
Preoperative Intraarticular Injection of Methylprednisolone in Patients Scheduled for Total Knee-arthroplasty

Despite improvements in analgesic treatment following total knee arthroplasty (TKA) for osteoarthrosis, a substantial part of patients still have severe acute pain after surgery. It has been suggested that preoperative degree of intraarticular inflammation is associated to postoperative degree of pain and level of function. Furthermore it is known, that patients with preoperative inflammation have hyperalgesia and severe movement related pain.

The aim of this study is to investigate the effect of a preoperative intraarticular injection of Methylprednisoloneacetate in reducing acute postoperative pain after total knee arthroplasty in patients with signs of severe pre-operative inflammation and pain.


Eligibility Criteria:
Inclusion Criteria:

* Age 50 -80
* Osteoarthrosis
* Scheduled for primary unilateral TKA
* Preoperative pain report with NRS \> 5 upon walking
* Signs of sensitisation in knee

Exclusion Criteria:

* Allergies to methylprednisoloneacetate, lidocaine or standard analgesic treatment
* Deficient written or spoken danish
* Impairment from psychological or neurological disease
* Local og systemic infection
* Immunodeficiency
* Treatment with corticosteroid within 30 days of inclusion
* Insulin treated diabetes mellitus
* Anticoagulant therapy
* ASA (American Society of Anaesthesia) class \> 3
* General anaesthesia
* Alchohol use \> 21 units / week
* Pregnancy
MK-1006 Single Dose Study in Japanese Type 2 Diabetes Patients (MK-1006-005)

A single rising dose study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of MK-1006 in Japanese participants with Type 2 Diabetes Mellitus (T2DM). The primary hypothesis of the study is that single doses of MK-1006 will be sufficiently safe and well tolerated, based on the assessment of clinical and laboratory evaluations and adverse experiences, in Japanese participants with T2DM.


Eligibility Criteria:
Inclusion Criteria:

* Japanese male or female between 20 to 64 years of age
* Diagnosis of type 2 diabetes
* Patient is being treated with diet and exercise alone or single oral anti-hyperglycemic agent

Exclusion Criteria:

* Subject has a history of type 1 diabetes mellitus
* Subject has a clinical diagnosis of glaucoma
* Subject has donated blood or participated in another clinical study in the past 12 weeks
* Subject is a regular user of any illicit drugs or has a history of drug, including alcohol, abuse in the past 6 months
Evaluation of the Neuroinflammation Pattern of BAY85-8102 F-18, DPA-714 in Probable Alzheimers Disease Patients Versus Healthy Volunteers and Radiation Dosimetry of F 18, DPA-714 in Healthy Volunteers

PET (positron emission tomography) imaging with BAY85-8102 F-18, DPA-714 for investigation of neuroinflammation pattern in probable Alzheimers patients versus healthy volunteers and radiation dosimetry in healthy volunteer.


Eligibility Criteria:
Inclusion Criteria:

* Able to give fully informed consent in writing
* Males or females aged \>/= 50 years
* No significant disease or drug use
* Absence of any sign of dementia/cognitive impairment in neuropsychological examinationsPatients for brain imaging:
* Patient and designee capable of giving fully informed consent in writing
* Patient fulfils DSM-IV and NINCDS-ADRA criteria for probable Alzheimers disease
* Patient has undergone physical and neurological examination, ECG and test of routine hematological and biochemical parameters prior to radiotracer administration Exclusion Criteria:- Pregnancy or lactation
* Current unstable medical condition (e.g. unstable angina, myocardial infarction or coronary revascularization in the preceding 12 months, cardiac failure, chronic renal failure, chronic hepatic disease, severe pulmonary disease, blood disorders, poorly controlled diabetes, chronic infection)
18572 - Sun Protection Factor Assay

To evaluate the Sun Protection Factor efficacy on human skin.


Eligibility Criteria:
Inclusion Criteria:

* Fitzpatrick Skin Type l, ll and/or lll for UVB testing. Fitzpatrick Skin Type ll, lll and/or lV for UVA testing.
* Male and female
* Aged between 18-70 years old.
* Good health as determined from the HRL SHF
* Signed and dated Informed Consent Form
* Signed and dated HIPAA Form
* An unambiguous MED or MPPD (Minimal Persistent Pigment Darkening Dose)

Exclusion Criteria:

* Subjects on test at any other research laboratory or clinic.
* Known allergy or sensitivity to sunscreens, cosmetics and toiletries, topical drugs and/or ultraviolet light.
* Pre-existing dermatologic conditions which have been diagnoses by a medical professional (e.g. psoriasis, eczema, etc.) which would interfere with this study.
* Pre-existing other medical conditions (e.g. adult asthma. diabetes).
* Treatment with antihistamines or corticosteroids within one week prior to initiation of the test.
* Treatment with antibiotics within two weeks prior to initiation of the test.
* Chronic medication which could affect the results of the study.
* Known pregnant or nursing women.
Confocal Endomicroscopy for Non-Erosive Reflux Disease Detection

Primary Objective:

Evaluate response to NERD treatment between patients with normal endomicroscopy findings compared with patients with abnormal endomicroscopy findings.

Secondary Objectives:

To evaluate the role of probe based endomicroscopy in the diagnosis of NERD by evaluating dilated intercellular spaces, evaluation of IPCL, and quantification of fluorescein leak.

Quality of life at study entry and end of study. Compare two medications under study within each group as a subgroup analysis.

The purpose of this study is to evaluate response to non-erosive reflux disease (NERD) treatment between patients with normal endomicroscopy findings compared with patients with abnormal endomicroscopy findings. The researchers will compare two different drug regimens for the NERD subjects to evaluate their effectiveness in reducing NERD-related symptoms. In addition, the researchers will be testing the function and effectiveness of the confocal endomicroscopy procedure to be used during the study. Researchers will be continuing to assess the status, symptoms, and any changes associated with the symptoms subjects are experiencing.

The confocal endomicroscopy procedure utilizes a powerful microscope that is used during an endoscopy. An endoscopy is a procedure that allows us to scope/view the inside of the esophagus and stomach using a camera in precise detail.

An endoscopy procedure and measurements of acid in the esophagus have been used to determine if the investigators think acid is causing the symptoms. Traditionally, acid blocking medications called proton pump inhibitors (PPIs such as Esomeprazole, Lansoprazole, Omeprazole, and Pantoprazole), or medications such as Sucralfate have been used to treat the symptoms of NERD.

The medical community believes that these symptoms are due to increased spaces between the cells that make up the esophagus. They can directly see those spaces using the confocal endomicroscopy.

Patients are asked to participate in this study if they are 18 years of age or older and have typical symptoms for patients diagnosed with NERD that have not responded to the first attempted medication.

Eligibility Criteria:
Inclusion Criteria:

1. Individuals older than 18 years who score a 12 or greater on the Reflux Disease Questionnaire and have failed a four week trial of daily proton pump inhibitor.
2. Subjects without gastroesophageal reflux disease (GERD) undergoing upper endomicroscopy for other indications will be recruited into study as controls.

Exclusion Criteria:

1. Barrett's esophagus
2. Use of twice daily proton pump inhibitor within 4 weeks of study entry
3. Esophageal varices
4. Coagulopathy (aspirin, NSAIDS and Plavix are allowed. Coumadin, Xarelto, heparin are not allowed.)
5. Gastrointestinal cancer or mass
6. Previous surgery involving the esophagus, stomach or duodenum
7. Pregnancy
8. Allergy to either sucralfate or proton pump inhibitors
Surufatinib Combined With Serplulimab Plus Chemotherapy in the Treatment of Extensive-stage Small Cell Lung Cancer

To evaluates the effectiveness and safety of Surufatinib combined with Serplulimab plus chemotherapy for the first-line treatment of ES-SCLC, and maintenance therapy are Surufatinib combined with Serplulimab


Eligibility Criteria:
Inclusion Criteria:

1. Patients must have the ability to understand and voluntarily sign informed consent;
2. Age: 18-75 years old;
3. Expected survival period ≥ 3 months;
4. Histologically or cytologically diagnosed with ES-SCLC (Combined small cell lung carcinoma excepted);
5. No prior systemic therapy for ES-SCLC;
6. According to the RECIST 1.1 standard, the patient has at least one target lesion with a measurable diameter;
7. ECOG PS: 0-1;
8. Major organs are functioning well;
9. The urine or serum pregnancy test results of premenopausal women were negative.

Exclusion Criteria:

1. Patients with symptomatic brain metastases;
2. People with hypertension who cannot be well controlled by double antihypertensive drug (systolic blood pressure≥140 mmHg, diastolic blood pressure≥90 mmHg);
3. Urine routine test showed urine protein ≥++ and confirmed 24-hour urine protein quantification\>1.0g;
4. Cardiovascular disease history: congestive heart failure\> New York Heart Association (NYHA) standard II, patients with active coronary artery disease (those with myocardial infarction 6 months before enrollment can be enrolled), arrhythmia requiring treatment;
5. Active severe clinical infections (\>NCI-CTCAE 5.0 version 2 infection criteria), including tuberculosis (clinical evaluation, including clinical history, physical examination, imaging findings and TB examination in line with local clinical practice), hepatitis B (known HBV Surface antigen \[HbsAg\] positive), hepatitis C or human immunodeficiency virus (HIV 1/2 antibody positive);Patients who have previously had HBV infection or have been cured (defined as the presence of hepatitis B core IgG antibodies and the absence of HBsAg) are eligible. Hepatitis C virus (HCV) antibody-positive patients are only eligible if the HCV RNA polymerase chain reaction is negative.
6. Patients with bleeding tendency or coagulation disorders;
7. In the past 2 years, there are active autoimmune diseases that require systemic treatment (such as corticosteroids or immunosuppressive drugs), and related alternative treatments (such as thyroxine, insulin, or physiological corticosteroid replacement for renal or pituitary insufficiency) are allowed treatment);
8. Patients who are pregnant or breastfeeding;
9. Allergy to any of the drugs in the study;
10. Imaging (CT or MRI) shows that the tumor invades or is poorly demarcated from large vessels;
11. Researchers think it is inappropriate to participate in this trial.
Mechanisms and Functional Outcomes of Exercise Progression Models in the Elderly

The aim of this study is to devise a sufficiently high intensity training program that provided an optimal stimulus to remove the peripheral factors known to reduce functional capacity, and can be cardiovascular and orthopedically well tolerated by the elderly. Findings from study laboratories have suggested that a regional specific training stimulus (RSTS) results in rapid improvements in both vascular and muscular function. RSTS is a novel combination of resistance training and aerobic training applied simultaneously, and in a serial manner, to specific regions of the body. It involves high-intensity and frequency muscle contractions, generating a targeted exercise stimulus, without producing excessive cardiovascular or orthopedic stress. The hypothesis is that initiating training with RSTS at multiple, strategically selected peripheral sites, in a serial manner will elicit local vascular and muscular changes, thereby preparing individuals at elevated risk of losing independence, to respond and progress more favorably to whole-body exercise.


Eligibility Criteria:
Inclusion Criteria:

* \>70 yrs of age
* Sedentary (exercising \<1 day/wk)
* Non-smokers
* Able to ambulate without use of an assistive device
* Able to walk between 200-450m on a 6-minute walk test

Exclusion Criteria:

* Oxygen dependent
* Recent medications changes (within 3 months)
* Current Smokers
* Fixed-rate pacemakers
* Uncontrolled hypertension or Type II diabetes
* Positive ECG changes or angina during CPX testing
* Unable to complete a maximal CPX to volitional fatigue
* AHA Class D, or NYHA Class III or IV heart failure
Postoperative Pain in Laparoscopic Radical Prostatectomy Surgery With Tranexamic Acid: Analgesia? Hiperalgesia?

Prostate cancer is the most diagnosed cancer among men today. Radical prostatectomy is a surgery that significantly reduces disease-related mortality. The laparoscopic technique, on the other hand, is preferred because it shortens the hospital stay, faster recovery and less postoperative pain.In this study, it was planned to investigate the analgesic or hyperalgesic effects of tranexamic acid, which is widely used in the management of bleeding in trauma, orthopedic, genitourinary and gynecological surgeries. Routine noninvasive monitoring (ECG, Spo2, NIBP) will be performed when participatient are taken to the operating table without premedication. After midazolam is administered, intubation will be performed by administering 1mg/kg lidocaine, 3mg/kg propofol, 2mcg/kg fentanyl, 0.6mg/kg rocuronium. Anesthesia will be maintained with desflurane with a MAC of 1. A 0.1-0.5 mcg/kg/min remifentanil infusion will be administered by targeting 40-60 values with BIS monitoring. After intubation, 15mg/kg tranexamic acid will be given 10 minutes before the incision, and 100 mg/h infusion will be administered until the skin is closed. The control group will be given 100 ml of saline.1mg/kg tramadol and 1gr parol will be administered 30 minutes before the end of the operation. The primary objectives of the study were to learn the VAS (Visual analog scale) score at 0.6,12, 24,48,72 hours, time to first analgesic requirement, and analgesic requirement within 24 hours. Secondary purposes are to determine the amount of antiemetic used, at the beginning of the operation, Hg at the first hour and postoperative 6 hours, complications and side effects (such as DVT, pulmonary embolism).

Prostate cancer is the most diagnosed cancer among men today. Radical prostatectomy is a surgery that significantly reduces disease-related mortality. The laparoscopic technique, on the other hand, is preferred because it shortens the hospital stay, faster recovery and less postoperative pain.In this study, it was planned to investigate the analgesic or hyperalgesic effects of tranexamic acid, which is widely used in the management of bleeding in trauma, orthopedic, genitourinary and gynecological surgeries

Eligibility Criteria:
Inclusion Criteria:

* Elective laparoscopic radical prostatectomy will be performed; Surgeon with more than 10 years of laparoscopic prostatectomy experience
* Participant BMI(weight/height2)(kg/m2)\<35
* ASA2-3
* Participant Age\>18
* Participant Age\<75

Exclusion Criteria:

* Coagulation disorder,
* Chronic renal failure,
* Patients allergic to tranexamic acid,
* Participant Age\<18
* Participant Age\>75,
* Participant BMI(weight/height2)(kg/m2)\>35,
* Surgeon with less than 10 years of laparoscopic prostatectomy experience,
* Patients who had a cerebral, coronary and thromboembolic event within 6 months before the operation
A Study to Assess the Impact of Implementing Modified Early Warning Score in Terms of Competency and Self-efficacy of Nurses at ILBS, Delhi

In this study nurses will be taught regarding Modified Early Warning Score and how to mark the involved physiological parameters in the MEWS chart and then scoring will be given i.e MEWS score and according to the score intervention would be taken by nurses by communicating with other health team members. this scoring will allow nurses to assess early deterioration and early ICU admission and at last nurses will be asked regarding the barriers or facilitators they faced while performing MEWS score.


Eligibility Criteria:
Inclusion Criteria:

* registered nurses working in general, semi-private and private ward nurses willing to participate

Exclusion Criteria:

* registered nurses who will not be present at the time of data collection. pull out staffs.
Anesthetic Gas Leakage in Children During Tonsillectomy: a Comparison of Cuffed and Uncuffed Tracheal Tubes

Fires and operating room pollution may occur when anesthesia gases leak into the oropharynx during airway surgery. Investigators sought to measure the concentrations of anesthetic gases that leak into the mouth of children undergoing adenotonsillectomy using cuffed and uncuffed tracheal tubes during spontaneous and controlled ventilation.

For the past 6 decades, uncuffed tubes have been used for the children less than 8 years of age out of a fear that cuffed tubes would cause damage to the subglottic region. The correct size uncuffed tube creates a seal in the subglottis that has minimal pressure on the mucosa. However, cuffed tubes have become more widely used in children recently without causing damage to the mucosa. There is very little literature comparing the magnitude of the gas leaks with cuffed and uncuffed tracheal tubes particularly in children. Several authors suggest that the leak of nitrous oxide and sevoflurane with uncuffed tubes was much greater than with cuffed tubes. One important but poorly studied issue is the risk of an airway fire when cautery is used for tonsillectomy because a large leak of oxygen in the mouth could ignite a fire. It also remains unclear whether the mode of ventilation, spontaneous or controlled, affects the leak of gases into the mouth. One might expect that the gas leak with spontaneous ventilation is less than with controlled ventilation, but it may not matter in the context of the small concentrations of oxygen and sevoflurane that investigators use. To address all of these concerns, investigators designed this study to compare the concentrations of gases (oxygen, carbon dioxide, nitrous oxide and sevoflurane) in the oral cavity of children undergoing T\&A with either cuffed or uncuffed tubes, during spontaneous and controlled ventilation.

Eligibility Criteria:
Inclusion Criteria:

1. American society of anesthesiologists physical status 1 and 2;
2. fasted
3. scheduled for elective adenotonsillectomy

Exclusion Criteria:

1. refusal of consent by parents
2. difficult tracheal intubation
3. craniofacial anomalies
4. gastroesophageal reflux
5. malignant hyperthermia
6. randomization to a tracheal tube is unacceptable.
Developing a Discrimination Model to Diagnose ALS

To combine several brain imaging techniques to develop a new diagnostic test to help with earlier diagnosis of amyotrophic lateral sclerosis.

Early diagnosis and lack of understanding of the pathophysiology of ALS remain a significant obstacle to making a timely intervention to help patients suffering from this fatal disease. We envision a future in which neuroimaging techniques will be a critical tool in the diagnostic work-up of ALS. Advanced neuroimaging techniques offer great potential in identifying central nervous system metabolite and cellular alterations in ALS. We propose an innovative approach to combine complementary advanced MRI techniques to interrogate brain chemistry (MRS), brain microstructure (DTI) and brain function (fcMRI) and develop a clinically relevant discriminatory disease model.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age or older
2. subjects with ALS (amyotrophic lateral sclerosis)
3. healthy subjects -

Exclusion Criteria:

1. Active substance abuse
2. Has co-morbid psychiatric disease
3. Has opportunistic CNS (central nervous system) infection
4. Has a history of head injury
5. Has a contraindication for MRI (e.g. cardiac pacemaker, ferromagnetic or metallic implants)
6. Pregnant
Neurocutaneous Melanocytosis Registry

This study will involve collecting information about the regular medical care you receive for large cutaneous melanocytic nevi (LCMN) or neurocutaneous melanocytosis (NCM).


Eligibility Criteria:
Inclusion Criteria:

* Patients with LCMN, defined as:

  * Dark-colored patch of skin present at birth
  * Can be located anywhere on the individual's skin
  * May include satellite lesions
  * May be associated with hypertrichosis

OR, in absence of cutaneous involvement:

* histologically or radiographically confirmed CNS melanocytosis.

  * Any age at diagnosis.
  * Signed informed consent by a patient, or parent/legal guardian.
  * Deceased patients can be included provided that parent/legal guardian is contacted at least 6 months after the death of the child and not on the child's birthday or anniversary of death.

Pathology review at MSK is not mandatory to confirm the diagnosis of LCMN or NCM. We will not require pathology analysis of leptomeningeal deposits in patients where characteristic skin lesions are present and melanosis of the meninges is radiographically evident. However, if pathology samples have already been obtained as part of a patient's evaluation and treatment at another institution, tissue samples will be requested for review and confirmation of the diagnosis.

Exclusion Criteria:

* Informed consent has not been provided.