cyrilzakka/clinical-trials huggingface dataset:
A Phase 1, Single-Ascending-Dose, Safety, Tolerability, Pharmacokinetic(PK), and Pharmacodynamic(PD) Study of BIIB068 in Healthy Participants

The primary objective of the study is to evaluate the safety and tolerability of single oral doses of BIIB068 in healthy participants. Secondary objectives are to characterize the single-oral-dose Pharmacokinetic (PK) of BIIB068 in healthy participants, to determine the effect of food on the single-oral-dose PK of BIIB068 in healthy participants and to examine the effect of administration of the proton pump inhibitor (PPI) esomeprazole on the single-dose PK of BIIB068 in healthy participants.


Eligibility Criteria:
Key Inclusion Criteria:

* All male subjects must practice highly effective methods of contraception during the study and be willing and able to continue contraception and not donate sperm for at least 1 spermatogenic cycle (90 days) after administration of last dose of study treatment.
* All female subjects of childbearing potential must practice highly effective methods of contraception during the study and be willing and able to continue contraception for at least 1ovulatory cycle (30 days) after their last dose of study treatment.
* Must have a body mass index (BMI) between 18 and 32 kg/m2
* Must be in good health as determined by the Investigator, based on medical history and screening evaluations.

Key Exclusion Criteria:

* History of any clinically significant cardiac, endocrine, gastrointestinal (GI), hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, or renal disease, or other major disease, as determined by the Investigator.
* History of severe allergic or anaphylactic reactions, or history of any allergic reactions that in the opinion of the Investigator is likely to be exacerbated by any component of the study treatment.
* Clinically significant abnormal laboratory test values, as determined by the Investigator, at Screening or Day-1.

NOTE: Other protocol-defined inclusion/exclusion criteria may apply.
Population Pharmacokinetics of Anti-infectious Drugs in Children

The Pharm A project is a French national collaborative project aiming to determine the population pharmacokinetics of ceftazidime, ciprofloxacin, and voriconazole in paediatric patients aged one month to five years.

The licensing process was introduced in order to ensure that medicines are safe, effective and of high quality. However, over 50% of children admitted to hospital in France and Europe will receive an unlicensed or off-label medicine. This occurs for most drugs in children less than 6 years of age. They represent a particularly vulnerable subgroup of the paediatric population.

There are major practical and ethical issues in relation to studying medicines in paediatric patients aged 5 years or less.

* They represent only a small part of the population as compared to older children and adults, and the variation of specific types of diseases in this young subpopulation is higher than in the paediatric counterpart. There are major differences in drug disposition in the different age groups.
* There is a need for suitable methodological approaches for clinical trials
* There are major ethical issues It is essential, therefore, to recruit children from various regions in France in order to obtain a critical sample size of sufficient magnitude and to conduct scientific sound studies. This will be achieved by performing Pharm A, a population pharmacokinetic study of three different anti infectious agents (ceftazidime, ciprofloxacin, voriconazole) and identify covariates including pharmacogenetic biomarkers that explain pharmacokinetic variability.

After parental informed consent, sampling strategy will be randomized depending on the drug and the age group (2 samples in patients below 2 years and 3 samples in patients from 2 to 5 years).

Eligibility Criteria:
Inclusion Criteria:

* Children aged 28 days to 11 years (\< 12 years)
* Receiving one of the following drugs for therapeutic reasons : ceftazidime, ciprofloxacin, voriconazole
* Representative for the clinician, a condition requiring the use of these molecules
* Informed consent signed by the two parents or legal representative
* Child affiliated to the national social security system

Exclusion Criteria:

Not Applicable
Tumor Characteristics and Survival Rate of HER2-Low Breast Cancer Patients

In this large-scale cross-sectional study, we evaluated disease-free survival (DFS), overall survival (OS), and clinicopathological characteristics of BC patients from 1991 to 2022, retrospectively. We recruited patients referred to the Cancer Research Center in Tehran, Iran, and their HER2 status, which is classified as HER2-low, HER2-positive, or HER2-negative, was obtained from prospectively maintained registries. we aimed to dive more deeply into the clinicopathological characteristics and survival features of HER2-low breast cancer patients and campared it with HER2-negative and HER2-positive groups.

Question 1: Is HER2-low breast cancer (BC) a new subtype in the standard classification of BCs? Question 2: How is the DFS and OS rate of HER2-low breast cancer patients in comparison with HER2-negative and HER2-positive groups?


Eligibility Criteria:
Inclusion Criteria:

All breast cancer patients with human epidermal growth factor receptor 2 (HER2) status in the database of the Cancer Research Center (CRC),from April 1991 to March 2022

Exclusion Criteria:

The male gender Patients with indeterminate or missing HER2 status, or patients with missing DFS and OS information
Cosmesis and Body Image After Single Port or 4-Port Laparoscopic Cholecystectomy

Laparoscopic Cholecystectomy (LC) is the treatment of choice for symptomatic gallstone disease. Single-port access cholecystectomy (SL) has been recently introduced using only one, trans-umbilical placed port. The method has been denominated as ''scarless.'' However, it is unknown whether SL significantly improves body and cosmesis images as well as the quality of life (QoL), reported directly by the patients. Furthermore SL promises to reduce postoperative pain and to be cost-effective due a faster postoperative recovery.

The aim of this Double Blind Randomized Controlled Trial (RCT) is to demonstrate whether SL is superior to LC in improving patients', body and cosmesis images as well as QoL and to analyse cost-efficiency.

Based on the sample size calculations, a total of 110 patients will be randomised to either LC or SL. The primary endpoint will be the cosmetic score. Costs, pain, time to convalescence, quality of life and complications and will also be compared as secondary endpoints.

This study will provide evidence-based patient-oriented information regarding the SL procedure and its further use.


Eligibility Criteria:
Inclusion Criteria:

1. Patients above 18 years of age for elective cholecystectomy
2. Written informed consent from the subject
3. INR \< 1.4, platelet count \> 50'000/mcl

Exclusion Criteria:

1. Women in pregnancy
2. Contraindications on ethical grounds
3. Severe coagulopathy (platelet \< 50'000/mcl, double medication on platelet antagonists (Plavix and Aspirin), INR \> 1.4
4. liver cirrhosis
5. Enrolment of the investigator, his/her family members, employees and other dependent persons
36-Month Clinical Evaluation of a Universal Adhesive

The aim of this clinical trial was to evaluate and compare the performance of a universal adhesive with different adhesive strategies in the restoration of non-carious cervical lesions (NCCLs) over a 36-month period.

One hundred sixty-five NCCLs in 35 patients (13 female, 22 male) with at least 3 lesions were included in this study. Three groups were formed according to adhesive strategies used (n=55): selective-etch mode; etch-and-rinse mode (ER); or self-etch (SE) mode of a universal adhesive, Single Bond Universal. The same nanofilled resin composite, Filtek Ultimate was used for all restorations by a single operator. The restorations were evaluated by two calibrated examiners at baseline and at 6-, 12-, 18-, 24- and 36- months in accordance with the modified USPHS criteria. The Chi-square test was used for intergroup, the Cochran Q test was used for intragroup comparison.

Eligibility Criteria:
Inclusion Criteria:

* over 18 years old
* good oral hygiene
* available for recall
* at least 20 teeth under occlusion
* the presence of at least three non-carious cervical lesions

Exclusion Criteria:

* poor oral hygiene
* bruxism habits
* severe or chronic periodontitis
* If the teeth selected for study, were nonvital, or had any restorations on other surfaces were not included.
Strategies to Reduce Addiction Stigma Among Health Professionals

The aim of this study was to evaluate the effects of exposure to stigma reduction message frames communicated by visual campaigns and narrative vignettes among a national sample of health professionals.

This randomized experiment evaluated the impact of exposure to message frames communicating the importance of non-stigmatizing language regarding addiction and the effectiveness of medication treatment for opioid use disorder delivered through a visual campaign alone or through a visual campaign in addition to a narrative vignette from the perspective of one of three messengers (a person with opioid use disorder, a clinician, or a health system leader) on attitudes toward people with opioid use disorder and medications for treating opioid use disorder among a national sample of health professionals.

Eligibility Criteria:
Inclusion Criteria:

* employed as health professional in the United States, including clinicians (e.g., physicians, nurses, physician assistants, pharmacists, and optometrists), technicians and technologists (e.g., laboratory technologist or technician, emergency medical technician, paramedic, licensed practical or licensed vocational nurse, medical records or health information technician, etc.), health aids and assistants (e.g., nursing aide, home health aide, medical assistant, pharmacy aide, phlebotomist, etc.)
* participant in existing web-based survey panel (IPSOS's KnowledgeNetworks panel and partner opt-in panel)

Exclusion Criteria:

* not employed in health profession
* not able to complete experiment and survey in English
High-Intensity Interval Training and Intermittent Fasting on Body Composition and Physical Performance in Active Women

The objective of this study is to compare the body composition and physical performance effects of HIIT, with or without intermittent fasting intervention in active women. Fourteen active normal weight women aged 18-35 participated in the study. The effects of 2x8 weeks without (HIIT) or with (HIIT+IF) intermittent fasting caloric restriction (20% reduction in weekly energy intake) on body composition and performance (Hand-grip strength, Counter movement jump, Wingate Anaerobic 30 s Cycling Test), were compared. There were two weeks in between both phases when they did not perform the scheduled activity, so as not to alter the experimental phase.


Eligibility Criteria:
Inclusion Criteria:

1. No muscular, ligamentous, bone, nerve or joint pathology incompatible with the training program.
2. Not to present cardiovascular or cardiorespiratory problems.
3. Physically active in the last 5 years, according to the American College of Sports Medicine (ACSM) definition.

Exclusion Criteria:

1. Following pharmacological treatment or supplement.
2. Performing other sports activities that may influence the study results during their participation in the study.
3. Not following training or diet program guidelines or attending scheduled training sessions.
Effects of MSPrebiotic on Gut Health in the Elderly

The purpose of this clinical trial is to study the effects of potato resistant starch on the microbiota (microorganisms or bacteria) and short chain fatty acids levels of the gut. Levels will be measured and compared between elderly adults and in pre-elderly, adults from the general public. A correlation between the use of potato resistant starch and specific clinical and quality of life endpoints between elderly adults and in pre-elderly, adults from the general public will be studied.

Hypothesis 1: The investigator hypothesizes that the microbiome in elderly adults (≥70 years) is less diverse and more prone to imbalance compared to adults (30-50 years) from the general population and that this imbalance of the gut microflora in the elderly adults is partially related to inadequate RS in their diet.

Hypothesis 2: The investigator hypothesizes that ingestion of potato resistant starch of food grade quality (MSPrebiotic) will stabilize the gut microbiome (i.e. high Firmicutes/Bacteroides ratio)in LTC residents (i.e. similar to that of adults from the general population), thereby improving gut health and reducing the risk of diarrhea and/or gut infection.

To assess the impact on the potato resistant starch on the microbiota, pyrosequencing will be performed on stool samples to determine the original composition and assess any changes over the study period. In addition the impact of the potato resistant starch on inflammatory markers will be assess through blood samples collected over the study period.

Eligibility Criteria:
Inclusion Criteria:

* Ability to provide written informed consent
* Willing to provide stool and blood specimens 5 times over the 14 week study period
* Subjects ≥ 70 years of age
* Subjects 30-50 years of age

Exclusion Criteria:

* Pregnancy
* Crohn's disease or any other inflammatory bowel disease
* Individuals with Lupus, or on cancer chemotherapy
* Pre-diabetes or Diabetes
* Thyroid disease
* Renal disease
* Hepatic disease
* Previous gastrointestinal surgery (intestinal resection, gastric bypass, colorectal surgery)
* Subjects on probiotic
* Subjects on antibiotics at time of recruitment or on antibiotics within the previous five weeks
* Individuals experiencing dysphagia
* Subjects using additional fiber supplements
* Subjects on digestants, emetics and antiemetics, medications for acid peptic disease and antacids.
Evaluation of the Veriton SPECT/CT System

The main purpose of this study is to evaluate a new type of gamma camera (the Veriton system) that provides a significant gain in system sensitivity and improved image quality compared to a conventional gamma camera that can achieve equal or better image quality than a standard SPECT/CT system.


Eligibility Criteria:
Inclusion Criteria:

* Adults age 18 years or older.
* Currently scheduled to undergo a nuclear medicine exam.

Exclusion Criteria:

* Individuals under 18 years of age.
* Unwilling/unable to sign an informed consent form.
* Unable to lie on a Veriton imaging table for up to 40 minutes.
Pramlintide in Adolescents With Type 1 Diabetes

The investigators hypothesize that subcutaneous pramlintide as an adjunct to mealtime insulin immediately prior to meals can significantly reduce post-prandial glucose concentrations compared with mealtime insulin alone in children with type 1 diabetes.

This is a 36 day, randomized, two-arm, open-label study with a treatment arm (taking pramlintide before all meals) and a control arm (diabetes regimen as usual).

Participants aged 13-17 years who have been diagnosed with type 1 diabetes for more than 1 year will be invited to participate.Other inclusion factors are:

* HbA1c level between 7.5 and 10% inclusive
* Currently using carbohydrate to insulin ratio
* Acceptable form of birth control

Exclusion factors:

* Oral hyperglycemic agents or medications which might affect blood sugar levels
* Recurrent severe hypoglycemia requiring assistance in previous 6 months
* Diagnosis of gastroparesis and/or require use of drugs that stimulate gastrointestinal motility
* Previous use of pramlintide

The study consists of 2 overnight stays at the CTRC where a continuous glucose monitoring system will be worn for twenty-four hours. Blood will be drawn 15 minutes prior to start of each meal and for three hours following each meal. Meals will be controlled for carbohydrate, fat and protein content. Meals will be identical at each CTRC visit.

After a baseline visit for all participants, randomization will occur to either Treatment or Control.Bolus insulin will be adjusted for participants when beginning pramlintide and will likely remain at a reduced rate throughout the trial. All participants will have access to staff to assist with insulin dosing. There will be six mandatory phone visits over the 36 days to ensure the safety of participants in this study.

Insulin, glucose and glucagon levels will be assessed as well as pramlintide levels at final visit of the study. Hypoglycemic events will be tracked, as well as any other adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Between 13 and 17 years of age, inclusive
* Diagnosed with type 1 diabetes for \> 1 year
* Hemoglobin A1c between 7.5 and 10% inclusive
* Currently using carbohydrate to insulin ratio
* Acceptable form of birth control

Exclusion Criteria:

* Use of oral hyperglycemic agents or medications affecting blood sugar levels
* Recurrent severe hypoglycemia requiring assistance in past 6 months
* History of hypoglycemia unawareness
* History of gastroparesis requiring use of drugs that stimulate gastrointestinal motility
* Previous use of pramlintide
Effects of Education After Colorectal Cancer Screening

The aim of this study is to examine the effect of the education given to individuals undergoing colorectal cancer screening on their attitudes, beliefs and healthy lifestyle behaviors.

This study was planned to be conducted as a prospective randomized controlled study in a family health center in Istanbul. The universe of the research; The sample of individuals registered to the family health center will consist of a total of 70 individuals who meet the inclusion criteria for the study.

Patient Diagnosis Form, Colorectal Cancer Screening Attitude Belief Scale, Healthy Lifestyle Behavior Scale II will be used to collect data. Data will be collected at the first encounter, 1 month later, 3 months later, pre-test and post-test. In the research, individuals will be divided into two groups: intervention (n = 35) and control (n = 35). Training will be provided to the intervention group.


Eligibility Criteria:
Inclusion Criteria:

* Between 50-70 years old,
* Registered at the Family Health Center,
* Able to speak Turkish,
* No diagnosis of psychiatric disease and no history of anxiolytic drug use,
* They will have a Fecal Occult Blood test for the first time,
* Positive result of fecal occult blood test,
* Faecal occult blood test was positive and had a colonoscopy,
* Those who have not been diagnosed with colorectal cancer as a result of colonoscopy,
* Individuals who volunteer to participate in the research

Exclusion Criteria:

* Having had previous colon surgery,
* Individuals with a history of colorectal cancer will not be included in the study.
ImmunoPET Targeting Trophoblast Cell-Surface Antigen 2 (Trop-2) in Thyroid Cancer

The objective of the study is to construct a noninvasive approach 68Ga-THP-Trop2 VHH PET/CT to detect the Trop-2 expression of tumor lesions in patients with thyroid cancer and to identify patients benefiting from Trop-2 targeting antibody-drug conjugate treatment.

As a new trophoblast cell-surface antigen 2 (Trop-2) targeting PET radiotracer, 68Ga-THP-Trop2 VHH is promising as an excellent imaging agent applicable to various cancers. In this research, subjects with thyroid cancer or highly suspected recurrence detection underwent contemporaneous 68Ga-THP-Trop2 VHH and standard-of-care imaging (18F-FDG and 68Ga-FAPI PET/CT) either for an initial assessment or for metastases or highly suspected recurrence detection. Tumor uptake was quantified by the maximum standard uptake value (SUVmax). The numbers of positive tumor lesions of standard-of-care imaging and 68Ga-THP-Trop2 VHH PET/CT were recorded by visual interpretation. The diagnostic accuracy of 68Ga-THP-Trop2 VHH was calculated and compared to standard-of-care imaging.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (aged 18 years or older);
* Patients with newly diagnosed, highly suspected recurrence or previously treated metastases of thyroid cancer (supporting evidence may include MRI, CT, tumor markers, and pathology report);
* Patients who had scheduled both standard-of-care imaging (18F-FDG and 68Ga-FAPI PET/CT) and 68Ga-THP-Trop2 VHH PET/CT scans;
* Patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.

Exclusion Criteria:

* Patients with pregnancy;
* The inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
Tolerability Comparison of Differin® Cream 0.1% Versus Differin® Lotion 0.1% in Subjects With Healthy Skin

The purpose of this study is to compare the tolerability of Differin® (adapalene) Cream, 0.1% to Differin® Lotion, 0.1% in subjects with healthy skin treated once a day for three (3) weeks.


Eligibility Criteria:
Inclusion Criteria:

* Males or females aged 18 years and older
* Subjects with healthy skin as determined by the clinical grader

Exclusion Criteria:

* Subjects with a degree of skin pigmentation that interferes with the reading of skin reactions.
* Subjects with a condition or who are in a situation, which in the investigator's opinion may put the subject at risk, may confound study results, or may interfere with the subject's participation in the study.
* Subjects with known allergy to one of the components of the study drugs (refer to the package insert for Differin® Cream 0.1% and the investigator's brochure for Differin® Lotion 0.1%).
* Subjects who have participated in another investigational drug or device research study within 30 days of enrollment.
* Subjects with a washout period for topical treatment on the treated area less than 1 week for corticosteroids and/or 4 weeks for retinoids.
* Subjects with a washout period for systemic treatment less than 1 week for medications that may increase photosensitivity and/or 4 weeks for corticosteroids and/or 6 months for retinoids.
* Subjects with current sunburn, eczema, atopic dermatitis, perioral dermatitis or rosacea on the area to be treated.
* Subjects who foresee unprotected and intense UV exposure during the study (mountain sports, UV radiation, sunbathing, etc.)
Performance Study for InferRead CT Pneumonia.AI

A retrospective, blineded, multicenter study of the InferRead CT Pneumonia.AI to evaluate the performance in identifying non-contrast chest CT scans containing pneumonia findings.

This is a retrospective, blinded, multicenter study for the InferRead CT Pneumonia.AI. The primary endpoint will evaluate the software's performance in identifying non-contrast chest CT scans containing pneumonia. It will evaluate InferRead CT Pneumonia.AI in terms of sensitivity and specificity with respect to a ground truth, as established by trained thoracic radiologists, in the detection of penumonia. In addition, the study will compare time to notification for the InferRead CT Pneumonia.AI software with respect to the time to notification for the standard of care as established from available radiological reports.

1. To evaluate the performance of InferRead CT Pneumonia.AI.
2. To evaluate the effect of different factors such as CT manufacturer, CT scanning protocols and patient characteristics on the performance of InferRead CT Pneumonia.AI

Eligibility Criteria:
Inclusion Criteria:

1. Non-contrast chest CT DICOM scans
2. Contains both lung lobes
3. Slice thickness is less than 3 mm.

Exclusion Criteria:

1. Incomplete scan or corrupted scan
2. Irregular scanning, increased intrapulmonary density due to insufficient inspiration, and respiratory artifacts affecting the physician's judgment.
3. Altered or absent lung morphology in the postoperative patient.