cyrilzakka/clinical-trials huggingface dataset:
The Safety and Efficacy of Dexloxiglumide for the Relief of Symptoms of Functional Dyspepsia.

"Functional dyspepsia" has been defined loosely as "pain or discomfort centered in the upper abdomen." The symptoms can also include fullness, early satiety, bloating, belching, nausea, retching and vomiting. These symptoms may present with or without the co-existence of symptoms of heartburn or gastroesophageal reflux disease (GERD). Functional dyspepsia is a diagnosis of exclusion in which other disease states, such as ulcer, cancer, etc. are ruled out and the source of the pain is unknown.

The standard of care for most patients presenting with dyspeptic symptoms has been with proton pump inhibitors (PPI), regardless of whether or not the patient's symptoms include acid-related conditions, e.g., heartburn, GERD, etc. Although PPI treatment has yielded some success in these patients, there is a significant population of patients whose dyspeptic symptoms are not adequately treated with PPI's alone.

The purpose of this study is to evaluate the use of dexloxiglumide in the treatment of the symptoms of functional dyspepsia in patients whose dyspeptic symptoms are not being treated adequately with PPI's.


Eligibility Criteria:
Inclusion Criteria:

* Be male or female, 18 to 75 years of age, inclusive.
* Must understand English and be able to follow the instructions about completing the diary and questionnaires.
* At the time of Screening, have pain and/or discomfort in your upper abdomen for at least one day each week in the last month.
* At the time of Screening, have at least one other symptom of FD for at least one day each week in the last month.

Exclusion Criteria:

* Have a known hypersensitivity to dexloxiglumide, any PPI, or aluminum/magnesium-containing antacids
* Have a history of organic diseases, structural or biochemical, of the gastrointestinal system that can cause dyspepsia.
* Have active irritable bowel syndrome (C-IBS, alt-IBS, D-IBS).
* Have findings leading to a clinical suspicion of other secondary causes of dyspepsia, including endocrine, metabolic and neurological disorders.
* Have a body mass (BMI) value of greater than 38 (applies to both males and females).
* Have been enrolled in a previous investigational study of dexloxiglumide.
* Have received treatment with any investigational drug within a 30-day period, or 5 half-lives, whichever is longer, prior to study entry.
* Use or dependence on "prohibited" medications at study entry.
Liposomal Bupivacaine for Post-operative Pain Control in Adolescent Bariatric Patients

Liposomal bupivacaine (trade name Exparel) is a local analgesic that is designed to produce more long-term pain control. Bupivacaine, a widely used local analgesic, is stored within liposomes, which break down in soft tissue over time. Typical length of therapeutic effect for standard bupivacaine is up to 6 hours. The liposomal formulation of bupivacaine, however, has a length of therapeutic effect of up to 72 hours. Typical post-operative incisional pain is known to last for several days in most cases and is thought to peak between 1-2 days after surgery. Therefore, the benefit of most short-acting local analgesics does not overlap with the period of most need.

Use of liposomal bupivacaine has not been reported specifically for use in adolescent bariatric surgery. Our rationale is based on the notion that for most minimally invasive procedures, methods currently used for pain control provide good outcomes that liposomal bupivacaine may not necessarily be able to improve upon. It is critically important to minimize the narcotics for our bariatric surgical patients so they are mobilized early and frequently to minimize their risk for a deep venous thrombosis, which could become a pulmonary embolus. In addition, as these patients are prone to constipation after their operation as a result of their 2 week protein sparing liquid diet preoperatively, avoiding narcotics can reduce their chances of further challenges in return of their bowel function. For these reasons, we seek to investigate whether incorporating liposomal bupivacaine in the analgesic regimen for patients undergoing a laparoscopic sleeve gastrectomy will lead to improvements in patient-reported outcomes and decreased opioid utilization.

Eligibility Criteria:
Inclusion Criteria:

* patients who are undergoing a laparoscopic sleeve gastrectomy for severe obesity who are between 13 and 2018 years of age.
* Only patients treated at the Children's Hospital of Richmond at VCU will be included.

Exclusion Criteria:

* patients less than 13 or greater than 2018 years of age
* patients with an allergy to bupivacaine
* any patients undergoing any additional procedures at the time of the laparoscopic sleeve gastrectomy.
* English or Spanish proficiency will be necessary.
Revision Total Hip Replacement Arthroplasty and Hematologic Variables

Revision total hip replacement arthroplasty is a surgery having intra- and postoperative substantial blood loss. The investigators will investigate the relationship between the various hematologic variables and postoperative bleeding volume.


Eligibility Criteria:
Inclusion Criteria:

* revision total hip replacement

Exclusion Criteria:

* hematologic disease
* anticoagulant medication
* American Society of Anesthesiologists physical status 4 and 5
Endotracheal Tube Shapes for Intubation With Videolaryngoscope

In this study, investigators will compare the efficacy of two shapes of endotracheal tube molded by stylet in endotracheal intubation using videolaryngoscope (McGrath MAC®). The participants will randomly be divided into two groups; J-shaped tube and 60-degrees-curved tube.

Since the intubation using videolaryngoscope does not need straightened oral-pharyngeal-laryngeal axis, certain curvature of endotracheal tube is needed for the successful intubation using the videolaryngoscope.

Participants in both groups will be intubated with videolaryngoscope (McGrath MAC®). Stylet will be inserted in the endotracheal tubes and will be bent to a specific shape by the assigned group. In the J-shaped tube group, endotracheal tube will be molded to a shape similar to the blade of the videolaryngoscope (McGrath MAC®). In the 60-degrees-curved tube group, endotracheal tube will be bent 60 degrees. Time to intubation, intubation attempts and ease of intubation wil be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for the surgery under general anesthesia
* Adult patients from 18 years to 65 years
* American society of Anesthesiologist physical status 1,2,3

Exclusion Criteria:

* Previously diagnosed for the difficult intubation
* Pregnancy
* Obesity (Body mass index over 40 g/m\^2)
Sublingual Photobiomodulation in Parkinson's Disease

This study evaluates the use of photobiomodulation in the treatment of patients with Parkinson's disease. Half of participants will receive treatment with low level laser therapy and exercises in combination, while the other half will receive a placebo laser combined with exercises.


Eligibility Criteria:
Inclusion Criteria:

* patients with Parkinson's disease diagnosed with the criteria of the UK Parkinsons' Disease Society Brain Bank Clinical Diagnostic Criteria
* In the stages I to III of the disease according to Hoehn \& Yahr's Parkinson's disease staging scale - modified;
* Individuals of both sexes,
* with more than 50 years
* who sign the informed consent form

Exclusion Criteria:

* patients who present some adverse event during the development of the study,
* Who have another associated neurodegenerative disease,
* Have blood dyscrasia, HIV, heart failure, hepatic or renal insufficiency, infections, neoplasias, respiratory disorders, hypophysis and hypothalamus problems.
* Who fail to understand or perform procedures correctly because of physical and mental limitations.
Evaluation of FB-401 in Children, Adolescents and Adults (2 Years and Older) With Mild to Moderate Atopic Dermatitis

The purpose of this study is to evaluate the potential improvement in atopic dermatitis signs and symptoms following the application of FB-401 in patients 2 years or older with mild to moderate atopic dermatitis. FB-401 will be applied topically for 16 weeks and progress will be assessed by assessment of the skin and patient reports.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, ≥ 2 years of age
* Clinical diagnosis of atopic dermatitis as defined by Hanifin and Rajka criteria that has been present for ≥ 3 months before the screening visit
* Investigator Global Assessment (IGA) score of 2 (mild) or 3 (moderate) at Screening and Baseline/Day 1 using the validated IGA scale for atopic dermatitis
* EASI score ≥ 5 at the screening and the Baseline visit
* 5% to 30% (inclusive) body surface area of atopic dermatitis involvement at the screening and the baseline visit

Exclusion Criteria:

* Previous treatment within 4 weeks prior to the baseline visit with any of the following:
* Immunosuppressive or immunomodulating systemic drugs such as systemic (intravenous, oral, intra-articular or intramuscular) corticosteroids, azathioprine, methotrexate, cyclosporine
* Phototherapy or photo chemotherapy for atopic dermatitis
* Previous treatment within 1 week prior to the baseline visit with any of the following:
* Topical corticosteroids (does not include inhaled, intranasal or ophthalmic) or topical calcineurin inhibitors
* Topical phosphodiesterase type 4 (PDE4) inhibitor
* Use of emollients other than provided for the study
* Bleach baths
* Within 8 weeks or 5 half-lives (if known), whichever is longer, prior to the baseline visit with Janus kinase inhibitors or other investigational drug
* Within16 weeks or 5 half-lives, whichever is longer, prior to the baseline visit with dupilumab or other biologic agent to treat atopic dermatitis
* Within 1 year prior to the baseline visit with any live bacterial therapy
* Pregnant (or planning to become pregnant during the period of the study) or lactating females
Eating Behavior, Food Craving and Relation to Excessive Weight Gain in Patients Submitted to Liver Transplantation

Excessive weight gain, obesity and metabolic syndrome are highly prevalent in patients undergoing liver transplantation. Traditional methods of assessing dietary intake have failed to demonstrate an association between these problems and dietary intake. Patients with an indication for transplantation due to ethanolic cirrhosis, ex-smokers and those with a previous history of overweight were identified as being at greater risk for overweight and metabolic syndrome, and these factors may be related to the change in eating behavior after the operation. Objective: To evaluate the eating behavior, the occurrence of food craving and relation to weight gain, overweight and obesity after liver transplantation. Method: This is a cross-sectional study in which adult and elderly patients in follow-up at the Hepatic Transplant Outpatient Clinic of the Alpha Institute of Gastroenterology of the Federal University of Minas Gerais were evaluated for eating behavior and food craving. The evaluation of the eating behavior was performed with the help of the Three Factor Eating Questionnaire-R21 (TFEQ-R21), translated version and validated for Portuguese. Food Craving Questionnaires State (FCQ-S) and Trait (FCQ-T) and the Brazilian Inventory of Foods Related to Craving (FCI-Br) were used in the translated and validated versions for Portuguese. Demographic, lifestyle, clinical and anthropometric variables of the evaluated patients were obtained through electronic medical records. Weight gain was assessed by the difference between the current weight and the first post-transplant outpatient weight.


Eligibility Criteria:
Inclusion Criteria:

* Patients who undergone liver transplantation
* At least 18 years of age
* Patients regularly followed up at the Bias Fortes outpatient clinic
* Patients who agreed to participate in the study

Exclusion Criteria:

* Patients who were unable to write and who did not have an accompanying person present as a literate person
* Pregnant or nursing women
A Study to Evaluate the Safety and Pharmacokinetics of CNTX-6016 in Healthy Subjects

A Phase 1 double-blind, placebo-controlled, randomized single ascending dose incorporating an open-label, 2-period crossover, food effect cohort.


Eligibility Criteria:
Key Inclusion Criteria:

* Is in good general health as determined by Investigator's review.
* Has a body mass index (BMI) between 18 and 35 kg/m2.
* Non- or ex-smoker (\> 1 year) and has not used any nicotine containing products within 12 months prior to screening.
* For females, is not currently pregnant and is either of non-childbearing potential or willing to use an adequate method of birth control.
* For males, must agree to use barrier contraception and not to donate sperm.

Key Exclusion Criteria:

* History of or active cardiac disease, including congestive heart failure, angina, or any arrhythmia.
* Has any history or currently active type of cancer except excised or cured basal cell carcinoma.
* Has a gastrointestinal disorder that could interfere with the absorption of orally administered drugs.
* Has asthma or other severe respiratory disease (e.g., chronic obstructive pulmonary disease) requiring daily prescription medicine.
* Currently has kidney, neurologic, metabolic, or liver disease, or other organ system disease.
* Has a history, current evidence, or is being treated for depression, suicidal ideation, suicide attempt, or any other current psychiatric condition requiring active treatment.
* Has an immunological disorder such as, but not limited to, human immunodeficiency virus (HIV), acquired, or congenital immune deficiency syndrome; autoimmune diseases, such as, but not limited to, rheumatoid arthritis, systemic lupus erythematosus, seronegative spondyloarthropathies or vasculitis, or any infection.
* Has positive screening test for hepatitis B virus (HBV) or hepatitis C virus (HCV).
* Is pregnant, lactating, or planning a pregnancy during the study.
* Has used any prescribed medication within 30 days prior to the first admission or has plans to use any prescribed medication during the study (with the exception of hormonal contraceptives).
* Positive urine screen for alcohol, cotinine, THC and/or drugs of abuse.
* Ingestion of food or beverages containing grapefruit and/or grapefruit juice and/or pomelos during the 7 days prior to dosing and/or during the study period.
Docetaxel and PTK787 in Metastatic Breast Cancer Patients and Gynecological Cancer Patients

The main purpose of this study is to see if the study drug, PTK787, is safe and to find the highest dose that can be given safely without causing serious side effects.

* Patients will come to the clinic once a week to receive study treatment. To help reduce the chance of an allergic reaction patients will take Decadron tablets orally the night before, the morning of and the evening of receiving chemotherapy.
* The lead-in schedule of dosing is as follows: Day 1: Taxotere intravenously; Day 4: PTK787 orally; Day 14: Taxotere and PTK787.
* After the lead-in schedule, a cycle will consist of 28 days. PTK787 will be given orally once a day without interruption. Taxotere will be given on Day 1, Day 8, Day 15 and Day 22.
* Before each dose of Taxotere, blood tests, urine tests, and a physical exam will be done. A radiological evaluation will be done every two months. If the patients tumor remains stable or shrinks in size, they may continue to stay on the study.
* Patients should not eat grapefruit or drink grapefruit juice during this study.

Eligibility Criteria:
Inclusion Criteria:

* Recurrent gynecological cancers or metastatic breast cancer. Initial diagnosis must be confirmed histologically.
* Measurable disease or nonmeasurable disease
* Age \> 18 years
* ECOG performance 0,1,2
* 4 weeks or greater since major surgery, 3 weeks or greater since chemotherapy
* Certain lab values
* Negative for proteinuria

Exclusion Criteria:

* Four or more treatment regimens
* History or presence of uncontrolled CNS disease
* Prior biologic or immunotherapies less than 3 weeks prior to registration
* Prior full field radiotherapy less than 4 weeks or limited field radiotherapy less than 2 weeks prior to registration
* Prior therapy with anti-VEGF agents
* Peripheral neuropathy with functional impairment \> CTC grade 2
* Pregnant or breast feeding
* Concurrent severe and/or uncontrolled medical condition
* Chronic renal disease
* Acute or chronic liver disease
* Impairment of gastrointestinal function or GI disease
* Confirmed diagnosis of HIV infection are excluded at the investigators discretion
* Therapeutic warfarin sodium or similar oral anticoagulants that are metabolized by the cytochrome p450 system.
Pediatric International Nutrition Study 2018

This is a multi-site study of how nutrition is delivered to critically ill patients in pediatric intensive care units (PICUs) around the world. Each site will include mechanically ventilated children in their respective PICUs and record the details of what type and amount of nutrition was received. These details will be compared to goals designated by the clinicians caring for each patient. Data will be entered in a secure online remote data capture tool and managed by the lead researchers in Pediatric Critical Care Nutrition at Boston Children's Hospital, Nilesh Mehta, MD and Lori Bechard, PhD, RD. Data will be analyzed to better understand how different types and amounts of nutrition impact important PICU outcomes such as length of stay, ventilator time, incidence of infections, and mortality.

Specific aim 1: To examine the impact of energy and protein adequacy on clinical outcomes.

Specific aim 2: To describe world-wide patterns of nutritional therapies in the PICU.environment: use of guidelines/use of adjuncts (acid suppression, motility, etc.)/glycemic control strategy/etc. To describe these practices in subgroups of: cardiac, surgical, medical, oncology/stem cell transplant patients in the PICU.

Specific aim 3: To examine enteral nutrition practices, including timing, route (gastric vs. post pyloric), adjuncts, and enteral nutrition (EN) intolerance definitions, in PICU patients worldwide Specific aim 4: To examine the current practices around parenteral nutrition prescription during the first week of critical illness in the PICU; time of initiation (early vs. late), rationale, threshold for initiation.

Primary predictor: nutritional adequacy (energy, protein) Secondary predictors: nutritional status, use of guidelines/site level indicators (location, staffing), use of adjuncts (acid suppression, motility, etc.), EN intolerance, subgroups (cardiac, surgical, medical, oncology/stem cell transplant), EN route/timing

Eligibility Criteria:
Inclusion Criteria:

* Sites with at least 8 PICU beds with the capacity to designate a site-specific clinician for data collection, preferably a clinician with an interest in nutrition or a dietitian, are eligible to participate.
* Patients 1 month to 18 years of age, admitted to the PICU and requiring mechanical ventilation with an anticipated length of PICU stay of 3 days or more.

Exclusion Criteria:

* Sites with \< 8 PICU beds and/or no available clinician for data collection
* Subjects \< 1 month or \> 18 years, PICU length of stay \< 3 days, not mechanically ventilated, receiving compassionate care only towards end of life, or enrolled in a nutrition intervention trial
Tumor Metabolism of Head and Neck Cancer in Patients Who Underwent Radiation Therapy Measured With F-18-FDG-PET

The purpose of the study is to describe the regional and global FDG-kinetics in head and neck cancer during percutaneous radiation therapy.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed head and neck cancer not curable by surgery
* Karnofsky \> 70%
* Tumor volume and localization allow curative radiotherapy
* Written consent

Exclusion Criteria:

* Metastases
* Earlier radiotherapy of head or neck
* Pregnancy
* Secondary malignancy excluding dermal carcinoma T1 and Tis-carcinoma of cervix uteri
* Psychiatric impairment
Bioequivalence of Two Liraglutide Formulations in Healthy Volunteers

This trial is conducted in Europe. The aim of this trial is to test for bioequivalence of the phase 3a formulation of liraglutide (formulation 4) and the liraglutide formulation planned for phase 3b trials (final formulation 4).


Eligibility Criteria:
Inclusion Criteria:

* Good general health as judged by the investigator, based on medical history, physical examination including 12-lead ECG (electrocardiogram), vital signs and blood and urinary laboratory assessments
* BMI (Body Mass Index) of 18.0-27.0 kg/m\^2, both inclusive

Exclusion Criteria:

* History of any clinically significant renal, hepatic, cardiovascular, pulmonary, gastrointestinal, metabolic, endocrine, haematological, neurological, psychiatric disease or other major disorders that may interfere with the objectives of the trial, as judged by the Investigator
* Impaired renal function
* Any clinically significant abnormal ECG, as judged by the Investigator
* Active hepatitis B and/or active hepatitis C
* Positive human immunodeficiency virus (HIV) antibodies
* Known or suspected allergy to trial product(s) or related products
* Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures
* History of alcoholism or drug abuse, or positive results in alcohol or drug screens
* Smoking of more than 5 cigarettes per day, or the equivalent for other tobacco products
* Habitual excessive consumption of methylxanthine-containing (theophylline, caffeine or theobromine) beverages and foods (coffee, tea, soft drinks such as red bull, cola, chocolate) as judged by the Investigator
* Excessive consumption of a diet deviating from a normal diet as judged by the Investigator
Study to Evaluate Arthroplasty Specimens for Osteoarthritis of the Knee and Hip

The objective of this exploratory study is to evaluate the cellular and connective tissue composition of joints from patients with Osteoarthritis (OA) who have been treated with fasinumab, compared with those treated with placebo or Non-steroidal anti-inflammatory drugs (NSAIDs).


Eligibility Criteria:
Key Inclusion Criteria:

* Previously randomized to R475-PN-1523 (NCT02683239), R475-OA-1611 (NCT03161093), or R475-OA-1688 (NCT03304379) and received at least 1 dose of study drug
* Notified the site that they are planning a knee or hip arthroplasty during the parent study between randomization and 24 weeks after the last dose of subcutaneous (SC) study drug
* Patient's surgeon/pathologist is willing to coordinate with the site regarding preparation, storage, and shipping of joint tissue samples collected during arthroplasty surgery

Exclusion Criteria:

* None

Note: Other protocol Inclusion criteria apply