cyrilzakka/clinical-trials huggingface dataset:
Study in Healthy Male Subjects Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C] LC15-0444

This was an open-label, non-randomised, single-dose study in 6 healthy male subjects. Subjects attended a screening visit within 28 days before drug administration. Subjects were admitted to the clinical unit on the morning of the day before dosing (Day -1) and received a single oral administration of study drug in a fasted state on Day 1. Subjects were resident in the clinic for up to 7 days after dosing; they could be discharged sooner if a mass balance cumulative recovery of \>95% was achieved, or if a mass balance cumulative recovery of \>90% was achieved and \<1% was collected within 2 separate, consecutive 24 h periods. At specified times during the study period, blood samples were taken and urine and faeces were collected for PK analysis. Safety assessments were also performed.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy male subjects aged 30 to 65
2. Body Mass Index (BMI) of 18-35 kg/m2
3. Must be willing and able to communicate and participate in the whole study
4. Must provide written informed consent
5. Subject must agree to use an adequate method of contraception, during the study and for 12 weeks after the last dose of the investigational drug. Male subjects will be instructed to use appropriate contraception, including a barrier method (condom), in addition to any precautions taken by their partner;
6. Normal (or abnormal but not clinically significant) supine blood pressure (BP) and heart rate (HR)
7. Good state of health (mentally and physically) as indicated by a comprehensive clinical assessment (detailed medical history and a complete physical examination),electrocardiogram (ECG) and laboratory investigations (haematology, blood chemistry and urinalysis).

Exclusion Criteria:

1. Participation in a clinical research study involving investigational drugs or dosage forms within the previous 3 months
2. Subjects who have previously been enrolled in this study
3. History of any drug or alcohol abuse in the past 2 years
4. Regular alcohol consumption \>21 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine);
5. Subjects who admit to any current or previous use of Class A drugs such as opiates, cocaine, ecstasy, lysergic acid diethylamide (LSD) and intravenous amphetamines (Subjects who admit to occasional past use of cannabis will not be excluded as long as they have a negative drugs of abuse test and have been abstinent for at least 12 months)
6. Current smokers and those who have smoked within the last 12 months. A breath carbon monoxide reading of greater than 10 ppm at admission
7. Radiation exposure from clinical studies, including that from the present study,excluding background radiation but including diagnostic X-rays and other medical exposures, exceeding 5 mSv in the last twelve months or 10 mSv in the last five years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999, shall participate in the study
Collection of Plasma Samples for Squamous Cell Carcinoma of the Head and Neck Patients

The investigators will collect plasma samples at baseline, during treatment, and at progression.

In this study, the investigators will collect plasma samples at baseline, during treatment, and at progression. This plasma bank will be used to study the potential value of some biomarkers to predict treatment activity or resistance to cetuximab or other targeted agents

Eligibility Criteria:
Inclusion Criteria:

* patients treated with radiation therapy and cetuximab according to Bonner et al
* patients treated with cetuximab in combination with chemotherapy according to Vermorken et al.
* patients treated with a molecular targeted agent as a part of a clinical study

Exclusion Criteria:

* patients with another type of head and neck cancer
* patients non treated with targeted therapies
Best Rest: Rest Time Before Blood Pressure Measurement Trial

The objectives of this study are to:

1. Determine the impact of wait time before initiating BP measurement on BP variability
2. Determine the difference in BP variability between measurements by amount of initial rest.

The investigators also aim to:

1. To determine the total time required to obtain a BP measurement.

Hypertension guidelines recommend a minimum of five minute rest time prior to blood pressure (BP) measurements obtained for screening, diagnosis and management of hypertension. This recommended wait time is often not adhered to and is cited as a barrier to regular screening due to length of time, clinic workflow and provider burden. It is unclear if BPs obtained at different rest intervals would provide clinically similar measurements. This study therefore aims to determine if BPs obtained immediately or after 2 minutes are rest are non-inferior to the BPs obtained after the guideline recommended 5 minutes of rest. It also aims to determine the time required to measure BP from start to finish, to allow for easier identification of other potential barriers to regular BP screening practices in busy clinical settings.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-80 years

Exclusion Criteria:

* Presence of the following on both arms: rashes, gauze dressings, casts, edema, paralysis, tubes, open sores or wounds, withered arms, A-V shunts, or if blood has been drawn from arm within last week.
* Being mentally impaired, pregnant.
* Arm circumference exceeding 50 cm.
Waveform and Spectral Characteristics of Perioperative Wheezing

With the aid of computerized sound analysis, digital acoustic monitoring could provide a more sensitive, specific, and quantifiable indicator for perioperative respiratory abnormalities including wheezing. It is probable that the digital stethoscope has utility in the detection, monitoring, and resolution following treatment of acoustic changes characteristic of turbulent respiratory gas flow due to wheezing and/or the incomplete resolution of atelectasis following the re-initiation of ventilation in a collapsed lung.

Anesthesiologists still rely on use of a conventional stethoscope to detect abnormal breath sounds during and after surgery - this process is labor intensive, intermittent, relies on human experience and thus is highly subjective. In fact, even for the most basic assessments, e.g. endobronchial intubation, human auscultation is unreliable.1 Digital stethoscopes are able to both amplify and digitize airway sounds and also provide a mechanism to record and analyze them for features undetectable by a human. Several small, pilot studies have shown that acoustic waveforms from the lungs produce characteristic spectral patterns in specific pulmonary pathophysiologic states. At this time, there are no studies that examine the acoustic patterns specific to perioperative wheezing or lung re-expansion. With the aid of computerized sound analysis, digital acoustic monitoring could provide a more sensitive, specific, and quantifiable indicator for perioperative respiratory abnormalities including wheezing. It is probable that the digital stethoscope has utility in the detection and monitoring of acoustic changes characteristic of turbulent respiratory gas flow due to wheezing and/or the incomplete resolution of atelectasis following the re-initiation of ventilation in a collapsed lung. In addition, treatment of perioperative wheezing with an inhaled bronchodilator may lead to resolution of wheezing and this response to treatment may also be monitored using waveform and spectral characteristics of the acoustic patterns from the digital stethoscope.

Eligibility Criteria:
Inclusion Criteria:

Patients scheduled for either:

1. open thoracic or video-assisted thoracoscopic surgery under general anesthesia requiring one-lung ventilation
2. abdominal surgery with a known history of chronic obstructive pulmonary disease (as documented in the electronic medical record)

Exclusion Criteria:

* Emergency surgery
* surgery requiring the use of transesophageal echocardiography
* refusal of informed consent
* pregnancy
* esophageal surgery
* lung transplantation
* contraindications for placement of esophageal stethoscope including esophageal varices strictures, motility disorders, diverticula or a history of prior esophageal injury or surgery
* age less than 18 years old
* prisoner
Evaluation of BAY59-8862 in Taxane-Resistant Metastatic Breast Cancer Patients

Breast cancer is the most common form of cancer among women in developing countries, accounting for approximately one-fifth of all female cancers in the United States. Although mortality rates are declining in some countries, it remains the leading cause of death in women aged 40-55 years. The median survival for women with metastatic breast cancer is 2-3 years but there is significant variability in this population. The primary goals of treatment in patients with metastatic breast cancer are improvement or maintenance of quality of life and prolongation of survival. The taxanes, paclitaxel and docetaxel, were incorporated into the treatment of metastatic breast cancer in the 1990's. The usefulness of the taxanes is limited by the development of tumor resistance to these agents. This phase II trial with BAY59-8862 will be conducted to determine the anti-tumor efficacy of BAY59-8862 in taxane-resistant metastatic breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Female patients with a proven diagnosis of metastatic breast cancer
* Measurable disease as defined by the presence of at least one measurable lesion
* Patients must have received at least 3 weeks of continuous therapy with Taxane
* patient must subsequently develop progressive disease either during treatment or within 6 months after treatment
* Patients who failed on hormone therapy
* Life expectancy of at least 12 weeks.
* Adequate bone marrow, liver and kidney function
* Patients with active brain metastases may be included

Exclusion Criteria:

* Excluded medical conditions like: pre-existing neuropathy, active heart diseases or ischemia; surgery within 4 weeks of study entry; serious infections; HIV infection; chronic hepatitis B or C; patients with brain metastases must be without a seizure; hypersensitivity to taxanes; organ transplants; some previous cancers
* Excluded therapies and medications, previous and concomitant such as: anticancer chemotherapy or immunotherapy during the study or within 4 weeks prior to study entry; more than two prior anticancer chemotherapy regimens; radiotherapy during study or within 4 weeks prior to study entry; bone marrow transplant
* Others: pregnant or breast-feeding patients; women enrolled in this trial must use adequate barrier birth control measures during the course of the trial; substance abuse, medical, psychological or social conditions that may interfere with the patient's participation.
Impact on Anxiety of a Digital Application for Children Undergoing Scheduled Ambulatory Surgery

The prospect of pediatric surgery is a source of preoperative anxiety for children and their parents. It affects 50% of children waiting for surgery and the causes vary according to age. It has been shown that pre-operative anxiety in children often leads to behavioral changes. Pre-operative anxiety is often managed by pharmacological premedication. However, there are many alternative techniques to reduce children's anxiety before surgery.

The use of an application dedicated to pediatric anesthesia used from the moment of the anesthesia consultation would allow to reduce this anxiety by allowing a varied course of information involving the child in his preparation before the surgery.

First, it allows an evaluation of the pre-operative anxiety level of children via validated scales. Secondly, it provides information to the children using methods adapted to their age and level of understanding.

Thus, if this method were validated, other hospitals could use this application to develop a tool that would benefit the many children who undergo surgery each year.


Eligibility Criteria:
Inclusion criteria :

* Patients from 3 to 12 years old.
* Outpatient hospitalization for a scheduled surgery or procedure under general anesthesia.
* Clinically stable condition.
* Information note sent to parents and collection of their consent to their child's participation in the study.
* Parental affiliation to a social security system.

Exclusion criteria :

* Urgent intervention situation.
* Patient included in another study.
* No compatible hardware for the application or no internet connection (smartphone, tablet, computer).
* Patient not affiliated to social security.
* Mental retardation or psychoactive disorders.
* Intravenous induction.
* Need for premedication.
* Patient who had general anesthesia less than one year ago and/or after the age of 3.
* Patient who had surgery less than one year ago and/or after the age of 3.
* Child's refusal.
Attitudes Toward Physical Activity and Nutrition Intervention During Cancer Treatment

Twenty-five women will be followed through their breast cancer treatment. The women will be asked to provide their opinions and desires for lifestyle intervention at different times throughout treatment. In addition, basic clinical data will be collected . The primary goal of this pilot study is to investigate the physical and behavioral changes that occur in patients receiving treatment for breast cancer.

In this cross sectional, longitudinal, observational study, 25 women will be followed through their treatment for stage I-III breast cancer. The women will be asked to provide their opinions and desires for lifestyle intervention at four timepoints throughout treatment. In addition to qualitative data, basic clinical data will be collected (anthropometrics, vital signs, dietary intake, and physical activity). The primary goal of this pilot study is to investigate the anthropometric and behavioral changes that occur in patients undergoing adjuvant chemotherapy for breast cancer.

Aim 1: To better understand patients' attitudes toward and perceived barriers to nutrition and physical activity interventions during neoplastic treatment.

Hypothesis: Patients' reported attitudes, motivation, and perceived barriers will change throughout treatment.

Aim 2: To measure the physical and metabolic changes that occur throughout neoplastic treatment for breast cancer.

Hypothesis: Over 50% of the participants will gain body weight during treatment and metabolic parameters will trend with body weight change.

Eligibility Criteria:
Inclusion Criteria:

* Female
* ≥18 years of age
* Diagnosed with stage I, II or III breast cancer with plans to undergo endocrine and/or chemotherapy treatment (radiation in combination with one or more of these therapies is acceptable)
* Willing to complete up to 4 clinic visits

Exclusion Criteria:

* Have received neoadjuvant therapy for current diagnosis
* Currently receiving adjuvant chemotherapy or other adjuvant therapy that was initiated prior to study enrollment
* History of cancer and neoplastic treatment
Comparison of Adhesive Latch Device to Subcuticular Skin Closure at the Time of Cesarean Section

The objective of this study was to compare the an adhesive latch device (" Dermaclip") to subcuticular skin closure at the time of cesarean section. Currently, no studies exist comparing these two closure techniques. The hypothesis is dermaclip closure is faster than subcuticular closure. The null hypothesis is there is no difference in closure times. There is a study (see reference at bottom) that compares staples closure to subcuticular closure, but none comparing subcuticular to dermaclip closure. Dermaclip device is easily deployed and is expected to be as fast as staples closure compared to subcuticular as noted in the prior study referenced below.


Eligibility Criteria:
Inclusion Criteria:

1. Age greater than 18
2. Elective cesarean section
3. Term pregnancy

Exclusion Criteria:

1. Fever \>101F in the past 14 days
2. Antibiotics in the past 14 days
3. Suspected ongoing infection
4. Poorly controlled gestational diabetes
5. Allergic to adhesive
Cocoa and Metabolic Health in Prediabetes

The purpose of this study is to determine the impact of consuming cocoa on blood glucose levels, glucose metabolism, and other markers of pre-diabetes in overweight and/or obese individuals. Our hypothesis is that consumption of cocoa improves insulin sensitivity and glucose metabolism in subjects at risk for developing type-2 diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) greater than or equal to 25 and less than 40.
* Have at least one of the following: 1) impaired fasting glucose (IFG) after an overnight fast with plasma glucose concentration between 100-125 mg/dl, 2) impaired glucose tolerance (IGT) as identified by the standard Oral Glucose Tolerance Test (OGTT) with 2 hour plasma glucose concentration between 140-200 mg/dl following 75 g glucose OGTT, 3) HbA1c levels between 5.7-6.4% or 4) considered at risk to developing type 2 diabetes by the American Diabetes Association risk assessment. If subjects are above the prediabetic range for any of these tests (indicating they may be type 2 diabetic), they will be excluded and referred to their physician.
* Weight stable (+/-2 kg) for the last 6 months.
* Sedentary to recreationally active (less than 2 d/wk, 20 min/d).
* Have a blood pressure that is less than 160/100 mmHg, total cholesterol that is less than 300 mg/dl and a triglyceride concentration of less than 450 mg/dl.

Exclusion Criteria:

* Past or current history of coronary heart disease, stroke or major cardiovascular disease events, respiratory diseases, endocrine or metabolic diseases (including type 1 and type 2 diabetes), inflammatory bowel disease, cancer, or neurological or hematological disorders that would compromise the study or the health of the subject.
* Past or current history of gastrointestinal disorders (including lactose intolerance, ulcers, cancer (stomach, intestinal, colon, pancreatic, liver, etc) NASH, NAFLD, cirrhosis, IBD/IBS, celiac disease, etc).
* Current use of any medication including but not limited to cholesterol lowering medication (including fibric acid derivatives and niacin), antibiotics, immunosuppressive drugs, azole antifungals, non-steroidal anti-inflammatory drugs (NSAIDs), hormone replacement therapy or antioxidants/supplements.
* Use of antibiotics, prebiotics, or probiotics within the prior 3 months.
* Smoking or other tobacco use
* Habitual consumption of alcohol more than 2 servings/d for males and 1 serving/d for females.
* Strict vegetarians or vegans, or strong aversions to major food groups that may be part of the controlled diet.
* Recent surgery
* History of alcohol or drug abuse.
* Pregnant or plan to become pregnant
* Allergic to either lidocaine or bupivacaine
The Options 2 Study

The goal of this clinical trial is to investigate how well nicotine pouches and nicotine mini lozenges serve as substitutes for cigarettes when people try to switch from smoking to using these alternate nicotine products.

Participants will:

* Use nicotine pouches, nicotine mini lozenges, or no study product for a week and then try not to smoke for 3 weeks.
* Have 6 in-person research visits and 1 follow-up call
* Complete questionnaires at each study contact and use a smartphone app to record smoking and study product use

Researchers currently lack critical data needed to appraise the potential for nicotine pouches to benefit public health. Specifically, they do not know how readily smokers will adopt pouches, how effectively they can substitute for cigarettes when smokers are trying to avoid smoking, the role of nicotine dose in the ability of pouches to serve as a substitute, or the mechanisms that facilitate or hinder successful product transition. This study will address these questions using a 4-arm randomized controlled trial of adults who smoke ≥5 cigarettes daily and are not planning to quit smoking in the next 30 days. This study will provide a rigorous evaluation of the potential efficacy of a relatively modified risk new nicotine product as a substitute for combusted cigarettes. The head-to-head comparison with FDA-approved mini lozenges can inform tobacco regulatory policy decisions.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 21 years old (i.e., able to legally purchase tobacco products)
* able to read and communicate in English
* no plans to quit smoking in the next 30 days
* willing to stop using nicotine replacement or varenicline
* willing to stop using bupropion (i.e., Wellbutrin, Zyban) if they are currently using it only for smoking cessation
* smoking ≥ 5 cigarettes per day for the past 6 months
* exhaled carbon monoxide ≥ 6 ppm
* no nicotine pouch or smokeless tobacco (including snus) use within the last 6 months

Exclusion Criteria:

* currently in treatment for psychosis or bipolar disorder
* currently taking bupropion for non-smoking cessation reasons (e.g., Wellbutrin for depression)
* currently pregnant or breastfeeding
Pennington Generation Cohort

The Pennington Generation Cohort is an observational study comprised of Louisiana families. Families will be assessed at baseline for a variety of traits and behaviors, and then followed up over time to try to understand the role of lifestyle and the environment on the risk of developing obesity and other health outcomes.

Pennington Biomedical's Greaux Healthy initiative partners with communities to grow healthier generations by expanding the access and reach of Pennington Biomedical's evidence-based practices for the prevention and treatment of childhood obesity. As part of Greaux Healthy, the Pennington Generation Cohort will help evaluate the impact of the program. A sample of up to 1,500 children and adolescents and their families will be recruited from throughout Louisiana. An initial physical exam will establish a baseline for each family with respect to lifestyle behaviors, genetics, and body size/composition. This longitudinal cohort will also assess the association between participation in several childhood obesity prevention and treatment programs and subsequent obesity and related health outcomes. Members of the longitudinal cohort will be followed in the future through clinical visits, questionnaires, and through optional linkages to electronic medical records and administrative databases such as the National Death Index, Social Security Death Master File, and health registry data.

Eligibility Criteria:
Inclusion Criteria:

* Children, adolescents, and young adults (birth through age 24 years) and their nuclear family members\* and adults age 25+ who are expectant parents or are trying to conceive
* Self-reported resident of Louisiana
* Ability to understand instructions and complete all study procedures
* Able to provide informed consent (adults aged over 18 years)
* Able to provide assent (children 9 to 17 years)
* Able to communicate (oral and written) in English

Exclusion Criteria:

* Discretion of the Medical Monitor or Principal Investigator