cyrilzakka/clinical-trials huggingface dataset:
Substudy of the Accuracy of Ingestible Event Marker (IEM) Detection by the Medical Information Device #1 (MIND1)

The purpose of this study was to determine the accuracy of IEM detection by the MIND1 System by completing a series of Patch applications and IEM ingestions in the clinic.

The OSMITTER study protocol was designed as a master protocol governing multiple substudies for the rapid assessment of candidate subcomponents for the MIND1 System. This substudy was conducted to determine the accuracy of IEM detection by the MIND1 System by completing a series of Patch applications and IEM ingestions in the clinic.

Eligibility Criteria:
Inclusion Criteria:

* Healthy males or healthy non-pregnant females 18 to 65 years of age at the time of informed consent who are willing to either practice abstinence or 2 barrier methods of birth control or 1 barrier method and an oral contraceptive method
* Participants must be in good general health (not suffering from a serious chronic mental or physical disorder that has required or may in the near future require urgent medical care)
* Body mass index between 19 to 32 kg/m\^2
* Ability to eat the high-fat meal

Exclusion Criteria:

* Participants with a history of skin sensitivity to adhesive medical tape or metals
* Participants who, in the opinion of the investigator, is acutely psychotic or manic and has symptoms currently requiring hospitalization
* Participants with a history or evidence of a medical condition that would expose him or her to an undue risk of a significant adverse event (AE) or interfere with assessments of safety during the course of the trial
* Participants have received any investigational product within the last 30 days.
* Participants has a current history of drug or alcohol dependence that meets Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria
* Participants has the presence of cognitive impairment
* Participants currently taking antipsychotic medication
* Participants with a terminal illness
* Participants with a history of chronic dermatitis
* Participants with a history of gastrointestinal surgery that could impair absorption
* Female participants who are breastfeeding and/or who have a positive serum pregnancy test result prior to receiving trial medications
* Sexually active women of childbearing potential (WOCBP) who will not commit to using 2 forms of approved birth control methods or who will not remain abstinent during this trial and for 30 days following the last dose of trial medication
* Sexually active males who will not commit to using 2 of the approved birth control methods or who will not remain abstinent for the duration of the trial and for 90 days following the last dose of trial medication
* No permanent physical residence
* After resting for ≥3 minutes, have a sitting systolic blood pressure \<100 or ≥150 millimeters of mercury (mmHg) and/or diastolic blood pressure \<50 or ≥90 mmHg
* After resting for ≥3 minutes, have a sitting pulse rate \<35 or \>100 beats per minute
* Participants who, in the opinion of the investigator, should not participate in the trial
Autistic Features in Relation to Motor Function and Quality of Life in Children With an Autism Spectrum Disorder

Although motor limitations are not currently considered a as clinical manifestation of autism spectrum disorder, should not be ignored due to their high incidence and considerable influence on life quality functional activity


Eligibility Criteria:
Inclusion Criteria:

* Both sex,
* age ranges from 3 to 5 years,
* mild to moderate autistic features according to childhood autism rating scale ,
* were able to sit alone independently

Exclusion Criteria:

* Significant visual or auditory defects,
* history of cerebral palsy or psychiatric disorder (e.g attention deficit hyperactivity disorder)
Validation of an Urticaria Control Test

The aim of this study is to validate a previously developed patient reported outcome instrument (in project UCT-D) to assess disease control in chronic urticaria patients (Urticaria Control Test - UCT) of age 12 and older.


Eligibility Criteria:
all patients suffering from chronic forms of urticaria are eligible
The Effect of Hydration on Postprandial Metabolic Responses

Certain populations, such as industrial workers and endurance athletes are particularly susceptible to dehydration due to exposure to heat for long periods of time causing evaporative water loss via sweating. The physical and cognitive decrements associated with dehydration have been widely researched, however the effect of dehydration on metabolism is lesser known. As climate change is causing temperatures to rise, and metabolic diseases such as type 2 diabetes are more common, the effect of dehydration on metabolism, specifically glycemic response to meals, needs to be established for future recommendations in clinical, environmental and athletic settings.

Therefore, the aim of this study is to investigate the effect of acute exercise-induced dehydration on subsequent metabolic responses to feeding (i.e. glycaemia and insulinaemia).


Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Generally fit and healthy
* Participate in endurance or intermittent exercise at least 3 times a week or minimum of 150 minutes moderate intensity activity per week

Exclusion Criteria:

* \< 18 or \> 45
* Any health condition that may affect study outcomes (e.g., endocrine/liver/renal/cardiovascular disease)
* Any morbidity that affects ability to cycle
* Smoker or vaper
Preclinical Validation of New Anti-melanoma Compounds

This research program is in keeping with the chemistry/biology/clinical interface and gathers 4 teams with complementary expertise in these respective fields. It will allow deciphering the mechanism(s) of action of new Thiazole-Benzenesulfonamide family (TZB) derivatives on metastatic melanoma sensitive and resistant to BRAF and MEK inhibitors. Investigators will use melanoma cell lines and primary cells from patients to validate these compounds in collaboration with clinical team 2 and 4. In conclusion, the investigators expect to establish the proof of concept that this new class of bioactive molecules (first in class) we developed in collaboration with Team 3 have the potential to go to the clinic for the treatment of highly aggressive cancers and particularly metastatic melanoma sensitive and resistant B-Raf and MEK inhibitors. Furthermore, the realization of this project can undoubtedly increase the knowledge of mechanisms and signaling pathways that are involved in resistant to BRAF and MEK inhibitors, and allow the selection of drug candidates capable of restoring the sensitivity of these melanoma cells.


Eligibility Criteria:
Inclusion Criteria:

* Patient with metastatic melanoma
* Not opposition of the patient will have been looked for

Exclusion Criteria:

* Primary resistance,
* Absence of resistance,
* Patient already included in other trials
Long-term Safety Study of Sublingual Fentanyl Tablets in Cancer Patients

The purpose of this study is to evaluate the long-term safety and effectiveness of EN3267 in treating breakthrough pain episodes in opioid cancer patients who are using stable doses of opioid medication.

This was a Phase 3 non-randomized, open-label, multicentre study designed to evaluate the long-term safety of EN3267 in the treatment of BTcP in opioid-tolerant cancer patients. The study was conducted in 2 parts:

1. A Titration Period during which patients had up to 2 weeks to determine a single, effective dose of study medication (EN3267) for adequate treatment of BTcP, and
2. A maintenance Period of up to 12 months in which episodes of BTcP were treated with study medication.

Eligibility Criteria:
Inclusion Criteria:

* Males or females 17 years of age or older.
* Stable cancer-related pain.
* Are receiving a stable, fixed-schedule oral opioid regimen equivalent to 60 to 1000 mg of oral morphine per day or transdermal fentanyl therapy equivalent to 50 to 300 µg/h, and are on a stable dose of opioid medication for relief of breakthrough pain.
* Experiencing 1-4 episodes of breakthrough pain per day.
* Meet the criteria defined in the Eastern Cooperative Oncology Group (ECOG) Performance Status for Grade 0, 1, or 2.

Exclusion Criteria:

* Have previously been exposed to EN3267.
* Are pregnant or lactating.
* Have uncontrolled or rapidly escalating pain.
* Have any clinically significant condition that would, in the investigator's opinion, preclude participation in the study or compromise data collection. These conditions may include cardiopulmonary disease, and/or neurologic/psychologic conditions.
* Are scheduled to take MAOIs (monoamine oxidase inhibitors) during the study.
* Are scheduled to receive anti-neoplastic therapy that, in the investigator's opinion, will influence assessment of breakthrough pain.
* Are scheduled to receive an investigational drug other than EN3267 during the course of the study.
* Have hypersensitivity, allergy or contraindication to fentanyl.
* Have significant prior history of substance abuse or alcohol abuse.
* Would have difficulty complying with the protocol, as assessed by the investigator.
* Are unable to read, write, or comprehend the English language in order to complete diaries.
Safety and Immunogenicity of V114 in Healthy Infants in South Korea (V114-036)

The primary purpose of this phase 3, single-arm, open-label study is to evaluate the safety and immunogenicity of a 4-dose regimen of V114 administered to healthy infants in South Korea.


Eligibility Criteria:
Inclusion Criteria:

* is a healthy South Korean male or female who is 42 to 90 days of age at the time of signing informed consent
* has a parent or legally acceptable representative who understands study procedures, alternative treatments available, and risks involved and voluntarily agrees to participate by signing informed consent

Exclusion Criteria:

* has a history of invasive pneumococcal disease or known history of other culture positive pneumococcal disease
* has known hypersensitivity to pneumococcal conjugate vaccine, any licensed pediatric vaccine to be administered concomitantly, or any diphtheria toxoid-containing vaccine
* has had a recent febrile illness (rectal temperature ≥38.1°C \[≥100.5°F\] or axillary temperature ≥37.8°C \[≥100.0°F\]) within 72 hours prior to receipt of study vaccine
* has known or suspected impairment of immunological function
* has or his/her mother has human immunodeficiency virus (HIV) infection
* has or his/her mother has hepatitis B surface antigen-positive test
* has known or history of functional or anatomic asplenia
* has a history of autoimmune disease
* has a history or suspected history of neurological disorder
* has received a pneumococcal vaccine prior to study entry
* has received, or is anticipated to need, corticosteroid therapy
* has received a blood transfusion of immunoglobulin products
* has participated in another clinical study of an investigational product
Use of Surgify Safety Burr in Hard Tissue Cutting, Head and Spine Area

Purpose of the study: To evaluate whether the SSB is safe, useful, beneficial and effective in drilling, cutting and removal of bone tissue in neurosurgical and spine procedures.

Sponsored observational clinical pilot study with no control group. Aim is to get a maximum of 20 study subjects, who have disease of the spine or head requiring surgery with bone removal and who are willing to participate into this study.

Eligibility Criteria:
Inclusion Criteria:

* Disease of the spine or head requiring surgery with bone removal
* Ability to understand the purpose and risks of the study and to give written informed consent
* Age 18-70 years

Exclusion Criteria:

* Previous surgery on the same area
* Abnormalities of bone tissue
* Vulnerable patient (such as prisoner, retarded person, person in nursing home, patient in emergency situation)
* Allergy or hypersensitivity to medical-grade stainless steel or any of alloying components
* Problems with blood clotting
18F-Labeled Picolinamide PET Imaging of Melanoma Diagnosis

The purpose of this study is to assess the dosimetric properties of the positron emission tomography (PET) imaging probe 18F labeled Picolinamide (18F-P3BZA) and preliminarily evaluate its diagnosis value in melanoma patients.

50 patients with pathology diagnosed melanoma will be enrolled for the clinical study. If agree to take part in this study, the patient will be performed with 18F-P3BZA PET/CT scan and 18F-FDG PET/CT scan in the other day before and after surgery. Next, all of the resected tissues from the patients will be checked with pathology.

6 of 50 patients are performed for whole-body PET scans at 0, 15, 30, 45, 60, and 120 minutes and a CT scan at 60 minutes after tracer injection (mean dose, 5.0 ± 0.5 mCi in 2.0 ± 0.5ml) will be performed. During the imaging period, 1 mL blood samples will be obtained for time-activity curve calculations at 1, 5, 10, 30,60, 90, 120, and 180 minutes after injection. The estimated radiation doses will be calculated by using OLINDA/EXM software.

The images produced by these scans will be compared to see the diagnosis value of 18F-P3BZA.

Screening Tests:

Women who decide to take part in this study will be asked if they think they might be pregnant at the start of the study. All of them must have a negative blood pregnancy test (Human chorionic gonadotropin, HCG).

PET-CT Scan Procedure:

Before the PET-CT scan is performed, patient will be asked to remove any metallic objects when she/he arrive at the PET-CT Center. After a property rest, he/she will be injected with about 5mCi 18F-P3BZA. The first scan will take at 60 minutes after injection and a delay scan will take at 120 minutes after injection. Each PET/CT scan will take about 20 minutes.

After 18F-P3BZA scan, the patient will be asked to avoid stressful exercise. Starting about 12 hours before 18F-FDG scan, he/she will be asked to limit the amount of carbohydrates until the scans are done.

Follow-Up Visits:

Patients' primary care physician will follow-up them for next 24 hours. After then, they may order additional imaging or surgical results after this study for follow-up purposes. The study doctor will review these results to compare them with the PET-CT images. The study doctors will also review the results of any biopsies you may have had as a result of PET-CT findings.

This is an investigational study. PET-CT and CT scans are FDA approved and commercially available.

Eligibility Criteria:
Inclusion Criteria:

* patients with melanoma: diagnosed by pathology and ready for surgery

Exclusion Criteria:

* patients with melanoma: refuse or cannot endure surgery
* pregnant women
Impact of Oropharyngeal Administration of Colostrum in the First 48 Hours of Life Term Premature Newborn ≤ 32 Weeks of Amenorrhea

Colostrum is the first milk secreted by the mother when the tight junctions of mammary epithelium open, allowing the cellular transport of a multitude of components and immunological protective derivatives of the maternal circulation to the milk, and especially immunoglobulins A type. Colostrum is not given to preterm neonates. The assumption behind this work is that the oro pharyngeal administration of colostrum early in preterm infants could help deliver an oral immunotherapy even before the installation of enteral nutrition, through interactions with lymphoid tissues of the oropharynx and the gastrointestinal tract. This practice would improve the digestive tolerance and the establishment of enteral feeding, the decrease in mucosal inflammatory phenomena, but also to provide any protection against subsequent infections. Finally, there could be an improvement in the secondary immune tolerance with a decrease in the occurrence of allergic phenomena.


Eligibility Criteria:
Inclusion Criteria:

* New premature infant with a term weight ≤ 32 weeks amenorrhea at Nice University Hospital
* Mother seronegative for HIV

Exclusion Criteria:

* Neonates with congenital pathologies immediate prenatal or neonatal diagnosis will not be included.
* Therapy of the mother incompatible with breastfeeding during pregnancy
Nurse-led Alcohol Brief Intervention Plus Mobile Personalized Chat-based Support on Reducing Alcohol Use in University Students

This study aims to assess the effect of personalized support using instant messaging application on alcohol drinking reduction in university students proactively recruited from universities in Hong Kong.

The government has promoted Hong Kong as the Asian's wine hub with zero alcohol tax (ethanol ≤30%) since 2008, which causes dramatic increases in alcohol drinking and binge drinking rates. Alcohol use in youth is the leading cause of disability adjusted life-years loss. Most adult drinkers start drinking at age 18-21. Evidence shows that alcohol brief intervention (ABI) is effective reducing hazardous and harmful alcohol use in university students. The proposed trial aims to enhance the ABI by incorporating information communication technologies (ICTs) such as instant messaging (IM) Apps (e.g. WhatsApp and WeChat) to provide personalized, real-time chat-based support led by nurses. The aims of study are as follows:

1. To determine the main effect of the Intervention vs. Control group on alcohol consumption per week at 6-month (Primary)
2. To assess the effects on alcohol consumption per week at 12-month, AUDIT scores at 6 and 12-month, perceived usefulness of IM app at 12-month, intention to use IM app to reduce/quit drinking at 12-month, number of standard drinks, episode of binge drinking, episode of heavy drinking, planned drinking, Academic Role Expectation and Alcohol Scale, Alcohol Problems Scale, Patient Health Questionnaire 4-item, Perceived Stress Scale 4-item, Covid-19 related drinking behavioral changes, and self-efficacy to reduce/quit drinking at 6-month and 12-month
3. To identify mediators between intervention and outcomes to inform the potential mechanisms
4. To qualitatively explore experience on the interventions for reducing alcohol use and related harms

Eligibility Criteria:
Inclusion Criteria:

* Student aged ≥18 years from local universities in Hong Kong
* Able to read and communicate in Chinese (Cantonese or Mandarin)
* Likely to stay in Hong Kong for most of the time in the next 12 months
* Using IM Apps (WhatsApp or WeChat) installed on a smartphone
* Baseline AUDIT screening score ≥8

Exclusion Criteria:

* Having a history of psychiatric/psychological disease or currently on regular psychotropic medications
* Currently participating in treatments or programmes on reducing alcohol use
Blood Pressure Effects of Nebivolol Versus Lisinopril in New Onset or Worsening Hypertension Induced by Bevacizumab

The purpose of this study is to directly compare the blood pressure (hypertension) reduction effects of lisinopril and nebivolol in patients who develop new onset or worsening hypertension while treated with bevacizumab.


Eligibility Criteria:
Inclusion Criteria:

* Patients currently treated at the University of Mississippi Medical Center Oncology Clinic
* Patient is being treated with bevacizumab either alone or in combination with other agents for cancer
* Patient blood pressure is \>140 mmHg (systolic) or \> 90 mmHg (diastolic), either treated or untreated with medications for hypertension
* Patients may be currently on medications for hypertension (other than Beta blocker, ACEI, or ARB); these will be continued at the same dose throughout the study
* Patients should be \> 18 years of age
* Patients receiving bevacizumab therapy approximately every 2 weeks

Exclusion Criteria:

* History of ACEI or ARB induced angioedema or idiopathic/hereditary angioedema
* Patient currently treated with a Beta blocker, ACEI, or ARB or have a history of intolerance to a medication in any of these classes
* Hyperkalemia, defined as a potassium value of \>5 mEq/L
* Pregnancy or breastfeeding
* Severe renal impairment (eGFR \<30 mL/min)
* Moderate hepatic impairment as identified by physician
* Currently taking CYP2D6 inducers (rifampin, carbamazepine or dexamethasone) or inhibitors (bupropion, fluoxetine, paroxetine, duloxetine, etc.)
* History of clinically significant EKG abnormality which would contraindicate beta blocker use
* Recent stroke (\<6 months)
* Recent myocardial infarction (\<6 months)
* Congestive heart failure
* Severe asthma or COPD
* Diagnosed obstructive sleep apnea
A Bioequivalence Study of Two Different Processes of PEG-rhGH Preparations

The purpose of this study is to investigate whether PEG-rhGH with new preparation is bioequivalent to PEG-rhGH with present preparation.

The purpose of this study is to investigate whether PEG-rhGH with new preparation is bioequivalent to PEG-rhGH with present preparation.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male aged ≥18 years old and≤45 years old;
* The Body mass index (BMI): 19-26 kg/m2 (inclusive), and body weight ≥50 kg;
* Normal results of physical examination, vital signs, laboratory tests, 12 lead-ECG, chest X-ray, abdominal ultrasound, or non-clinical significance changes in the assessments above.

Exclusion Criteria:

* Subjects with a history of hypersensitivity reactions or clinically significant hypersensitivity reactions to drugs containing; or a history of allergic diseases (including but not limited to asthma, urticaria, etc.), or allergic constitution (such as known allergy to two or more substances)
* Subjects with a clear history of disorders of the central nervous system, cardiovascular system, digestive system, respiratory system, urinary system, blood system, metabolic system, etc., or suggest potential diseases, such as abnormal laboratory test results of liver and kidney function (alanine aminotransferase \[ALT\] or aspartate aminotransferase \[AST\] exceeding the upper limit of normal, or total bilirubin exceeding the upper limit of normal; Or blood creatinine exceeding the upper limit of normal value); Or other diseases (such as a history of mental illness) deemed unsuitable for participation in the trials by the investigators;
* Subjects with severe infection, severe trauma, or major surgery within 6 months prior to screening;
* Subjects who have received blood transfusions, had blood donors, or lost blood ≥400 mL within 3 months before screening; Or plan to donate blood within 1 month of the end of the trial;
* Subjects who have positive results of human immunodeficiency virus antibodies (HIV-Ab), or hepatitis B surface antigen (HBsAg), or hepatitis C virus antibodies (HCV-Ab), or syphilis specific antibodies (TPPA);
* Subjects who have participated in clinical trials for medication or medical device within 3 months prior to screening;etc.
Evaluation of Effectiveness and Safety of XIENCE Sierra in Routine Clinical Practice

The objective of this study is to evaluate effectiveness and safety of Xience Sierra stent in the "real world" daily practice as compared with other drug-eluting stents.


Eligibility Criteria:
Inclusion Criteria:

* Age 19 and more
* Patient with Xience Sierra Everolimus eluting coronary stent
* Written consent

Exclusion Criteria:

* Intervention with Xience Sierra Everolimus eluting coronary stent and other drug eluting stent at the same time
* Life-expectancy less than 1 year
* Cardiac shock