cyrilzakka/clinical-trials huggingface dataset:
Safety and Immunogenicity of a Monovalent mRNA Vaccine Encoding Influenza Hemagglutinin in Adult Participants 18 Years of Age and Older

The purpose of this study is to evaluate the safety and immunogenicity of a single intramuscular (IM) injection of different dose levels of messenger ribonucleic acid (mRNA) vaccine encoding influenza hemagglutinin compared to an active control quadrivalent recombinant influenza vaccine (RIV4) in adults 18 years of age and older. Study details include:

Study Duration: approximately 6 months Treatment Duration: 1 injection of mRNA vaccine encoding influenza hemagglutinin encoding influenza hemagglutinin or control.

Visit Frequency: Screening visit, Day 01, Day 02, Day 03, Day 09, Day 29, Day 91, Day 181

Approximately 6 months

Eligibility Criteria:
Inclusion Criteria:

* Having given written informed consent prior to undertaking any study-related procedure. Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply:
* Any subject who, in the judgment of the Investigator, is likely to be noncompliant during the study, or unable to cooperate because of a language problem or poor mental development.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
A Study to Learn How Different Forms of the Study Medicine Called PF-07976016 Are Taken Up Into the Blood in Healthy Adults

The primary purpose of this study is to measure and compare the amount of study drug in your blood after a single dose of two formulations of study drug.


Eligibility Criteria:
Key Inclusion Criteria:

* Overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, vital signs and ECG assessments.
* Willing to provide consent and follow study requirements
* Total body weight \>110lbs (50kg)

Key Exclusion Criteria:

* Any condition affecting drug absorption, clinically significant laboratory values
* HIV, HepB \& HepC
* Serious illness or hospitalization, or other condition, that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
* Use of prescription or non-prescription drugs within a specified timeframe prior to the first dose of study intervention
* positive urine drug test at screening/admission
* History of alcohol abuse or repeated binge drinking and/or any other illicit drug use or dependence within 6 months of screening
* Use of tobacco/nicotine containing products more than the equivalent of 5 cigarettes/day or 2 chews of tobacco/day
The Efficacy of Different Types of Stretching on Range of Motion, Pain and Function in Elbow Limitation

The aim of the study is to compare the efficacy of Proprioceptive Neuromuscular Facilitation (PNF) stretching and static stretching on range of motion (ROM), pain and function in elbow limitation.

To compare the efficacy of PNF stretching and static stretching on ROM, pain and function in elbow limitation, forty voluntary patients with elbow limitation, aged between 18-55 years will be randomly divided into two groups: PNF Stretching group and Static Stretching group. PNF stretching will be combined with exercise and cold application in PNF Stretching group, static stretching will be combined with exercise and cold application in Static Stretching group, will be applied for 12 sessions. The patients will be assessed before and after six-week treatment. The pain on activity, at rest and at night will be assessed with Visual Analog Scale (VAS). ROM will be assesed with universal goniometer. The functional status will be evaluated by Disabilities Arm, Shoulder and Hand (DASH). Kinesiophobia and quality of life will be assessed with Tampa Scale for Kinesiophobia and Short Form-12, respectively. The Global Rating of Change will be used to evaluate patient satisfaction.

Eligibility Criteria:
Inclusion Criteria:

Subjectswill be included with

* Aged between 18 and 65 years
* Elbow fracture in the six months before the study
* Elbow limitation in flexion or extension
* Being volunteer to participate
* Fractures should be managed with conservatively or surgically

Exclusion Criteria:

* Malunion or Nonunion Fracture
* Occurrence of complex regional pain syndrome, peripheric nerve injury, heterotopic ossification, myositis ossification or post-traumatic ankylosing
* Non-healing wound or infection
* Previously received physiotherapy for elbow limitation
* Having any cardiovascular diseases, neurological disorders, rheumatic diseases or psychiatric diseases
* Could not adjust to treatment
Dual Energy CT: A New Method for Better Dose Calculation in Proton Beam Therapy

Researchers want to compare proton stopping ratios, used for proton beam therapy planning, calculated based on single energy CT and dual energy CT images; with the intension of improve upon the proton range determination.

The main goal of this study is to compare proton stopping ratios, used for proton beam therapy planning, calculated based on single energy CT and dual energy CT images.

The calculation methods for proton stopping power ratios differs for the two types of CT images, and researchers want to investigate if the proton stopping power ratio can be estimated more accurately by using dual energy CT. A more accurate stopping power ratio calculation gives a more accurate proton range determination in the patient tissue, which again will lead to a better knowledge of the dose distribution in the patient undergoing cancer treatment with proton beam irradiation.

Knowing the accurate dose distribution allows for an uncertainty margin reduction around the tumor, which will result in less normal tissue being irradiated and thereby the risk of side effects is reduced without risking an under-dosage of the tumor.

Eligibility Criteria:
Inclusion Criteria:

* Cancer patients who are scheduled for a control CT scan

Exclusion Criteria:

* Under 18 years of age
Effects of Adding Force Control to a VR Game on Brain Activation

One of the major contributor for the lower quality of living in the aged population, is the reduction in hand function. To mitigate this, several virtual-reality based hand rehabilitation/training systems have been developed.

However, most of these systems are solely controlled by hand gestures, and do not incorporate the force between the fingertips. Which is not the case for grabbing things in real life. With that in mind, the researchers assumed that a virtual-reality based hand rehabilitation/training system that incorporates force control into its input can be more beneficial in terms of recovering one's hand function.

To test out this claim, subjects were recruited and tasked to play a game using both input systems (wfc and wofc), while their brain activity while using both input system was simultaneously recorded using functional near infrared spectroscopy and compared


Eligibility Criteria:
Inclusion Criteria:

* With normal vision or wearing prescription glass that can fit inside the Meta Quest 2 VR headset.
* Able to understand English, Chinese, or Taiwanese language.

Exclusion Criteria:

* Experiencing motion sickness after prolonged usage of VR headsets
* Having chronic diseases or injuries that can prevent them from participating in the experiment such as: hand injuries, missing fingers, blindness, deafness, hearing impairments, etc.
Operating Room Air Filtration/Sterilization

Determine whether operating room air filtration and sterilization with the ActivePure system reduces a composite of serious surgical site infections, infection-related complications, and death within 30 days after surgery.

The investigators primary goal is thus to determine whether supplemental filtering and sterilizing operating room air reduces a composite of serious surgical site infections, infection-related complications, and death within 30 days after surgery. The primary outcome will be restricted to inpatients. However, outpatients will be simultaneously enrolled given the trial's cluster design. Sample-size is based on our primary inpatient analysis, N= 66,273 inpatients. Available outpatients will be included for analysis of our secondary outcome which includes both inpatients and outpatients.

Eligibility Criteria:
Inclusion Criteria:

* All patients in designated adult operating rooms
* American Society of Anesthesiologists physical status 1-4.
* Surgery lasting at least 1 hour.
"Study of the Effects of Serum and Follicular Fluid Relaxin Levels on Ovarian Function in IVF Cycles"

The study evaluated the effect of serum relaxin and follicular fluid levels on the number and quality of oocytes, fertilization, the number and quality of the embryos in IVF protocols.

Relaxin is one of the promising indicators of oocyte quality and prognosis of the effectiveness of invitro fertilization protocols. The hormone plays an important role in the processes of folliculogenesis, growth and maturation of oocytes, development of embryos, implantation processes, pregnancy and childbirth. A pilot study was conducted on a group of patients undergoing infertility treatment using assisted reproductive technologies in the superovulation stimulation protocol using gonadotropin releasing hormone antagonists. Blood and follicular fluid samples were obtained on the day of transvaginal follicular puncture. The results allow us to consider the hormone relaxin as a promising predictor of the result of ovarian stimulation, the effectiveness of fertilization in IVF cycles.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of Primary or Secondary infertility
2. Must be signed the voluntary informed consent to participate in the study.

Exclusion Criteria:

1. The presence of IVF contra-indications.
2. Clinical diagnosis of large uterine fibroids.
3. BMI\> 35 kg / m2
4. Morphological diagnosis of endometrial hyperplastic processes
5. Clinical diagnosis of infectious.
6. Clinical diagnosis of systemic autoimmune diseases.
7. Insulin dependent diabetes
8. Oncological diseases
Efficacy and Safety of Idelalisib (GS-1101) in Combination With Bendamustine and Rituximab for Previously Treated Indolent Non-Hodgkin Lymphomas

The primary objective of this study is to evaluate the addition of idelalisib to bendamustine/rituximab on progression-free survival (PFS) in adults with previously treated indolent non-Hodgkin lymphoma (iNHL).

An increased rate of deaths and serious adverse events (SAEs) among participants with front-line chronic lymphocytic leukemia (CLL) and early-line iNHL treated with idelalisib in combination with standard therapies was observed by the independent data monitoring committee (DMC) during regular review of 3 Gilead Phase 3 studies. Gilead reviewed the unblinded data and terminated this study in agreement with the DMC recommendation and in consultation with the US Food and Drug Administration (FDA).


Eligibility Criteria:
Key Inclusion Criteria:

* Histologically confirmed diagnosis of B-cell iNHL, with histological subtype limited to the following

  1. Follicular lymphoma (FL) Grade 1, 2, or 3a
  2. Small lymphocytic lymphoma (SLL)
  3. Lymphoplasmacytoid lymphoma/Waldenström macroglobulinemia (LPL/WM)
  4. Marginal zone lymphoma (MZL) (splenic, nodal, or extra-nodal)

Key Exclusion Criteria:

* History of lymphoid malignancy other than those allowed per inclusion criteria.
* Ongoing drug-induced liver injury, active hepatitis C, active hepatitis B, alcoholic liver disease, non-alcoholic steatohepatitis, primary biliary cirrhosis, extrahepatic obstruction caused by cholelithiasis, cirrhosis of the liver, or portal hypertension.
* Prior treatment with bendamustine that was not effective.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
A Comparison of Weighted Vest Exercise and Strength Training

The purpose of this study is to evaluate two types of exercise therapy designed to improve muscle power and mobility: weighted vest exercise vs. progressive resistance training.

Muscle power, a separate physical attribute from strength, is an important determinate of physical functioning in the elderly, for example in avoiding impending falls, rising from a chair, and climbing stairs. Muscle power, which declines with aging at a different rate than strength, has been shown in previous studies to improve through power training utilizing specially designed exercise equipment. However, weighted vest exercise could provide an acceptable, low cost, readily accessible alternative.

The hypotheses being tested in this study are: 1) weighted vest exercise will improve lower extremity power when compared to age matched controls in a standardized progressive resistance training program; 2) improvements in lower extremity power enhance functional performance as shown by improved gait velocity, stair climbing, and chair rise time; and 3) weighted vest exercise in impaired older adults will improve self-reported function and disability.

One hundred sixty-four men and women ages 65 and older, with some physical limitation but able to climb stairs independently, will be randomized to one of two 16-week exercise programs. The intervention group will participate in a weighted vest exercise protocol, consisting of chair-based and stair-climbing exercise, while the control group will participate in a standardized progressive resistance training program. Participants in both programs will meet three times per week for 30-60 minutes per session, for a total of 16 weeks, at a research exercise gym, and will be under the direct supervision of research staff.

Eligibility Criteria:
Inclusion Criteria:

* Community dwelling men and women aged 65 or older
* Ability to provide informed consent
* Impairment in physical performance, based on a score between 4 and 10 inclusive on the SPPB (Short Physical Performance Battery), which evaluates standing balance, walking speed, and chair-rise time
* Score of 24 or greater on the Folstein mini-mental status exam
* Exhibit independent stair-climbing ability

Exclusion Criteria:

* Unstable acute or chronic disease
* Neuromusculoskeletal impairment interfering with independent stair climbing
* Abdominal aortic aneurysm
* Exertional angina
* History of ventricular arrhythmia
* Inguinal or abdominal hernia
* Symptomatic valvular heart disease
Assessment Metabolic Flexibility in Middle-aged Individuals: The Nutritional Impact of Cheese Consumption

The aim of the study will be to evaluate the impact of consumption of meat and dairy products from extensive or intensive farming on apparently healthy individuals aged between 45 and 65 years, a stage of life associated with reduced metabolic flexibility and changes in lipid metabolism.

The study will analyze:

1. The transcription factor PPAR-α determined by the gene expression of PPAR-α in white blood cells, variations in circulating fatty acid metabolism, and the endocannabinoid system determined by circulating analysis of N-acylethanolamine (NAE), and 2-monoacylglycerols (2-MG);
2. Metabolic flexibility, determined by indirect calorimetry in fasting condition during an incremental exercise;
3. Body composition, determined by bioimpedance analysis, waist circumference, and waist-to-hip ratio.

The study will be a double-blind crossover intervention clinical trial conducted on the aforementioned individuals, who will consume "kent'erbas" cheese products, from extensive and intensive farming.

The study will include 105 individuals aged between 45 and 65 years, apparently in good health, recruited from the UTIC cardiology unit of A.O.U.CA Cagliari (Italy). All participants will be provided with a detailed explanation of the study procedures and its purpose, and their participation will be contingent upon signing an informed consent form. Throughout the study, subjects will maintain their regular lifestyle and unrestricted food intake.

At the outset of the study, relevant information necessary for an appropriate approach to each participant will be collected, including a comprehensive medical history, measurement of anthropometric parameters, and blood sampling for a thorough hematological, inflammatory, and lipid-metabolomic analysis.

In the pecorino study, subjects will consume 350g/week of "kent'erbas" pecorino from extensive farming or 350g/week of "industrial" pecorino from intensive farming for 4 weeks in total. At the end of this period, a blood sample will be taken. Subsequently, there will be a 8 weeks washout period during which participants will follow their usual diet without consuming either type of pecorino. At the end of the washout period, an additional blood sample will be taken. Following this, the participants who had consumed "kent'erbas" pecorino will switch to "industrial" pecorino for 4 weeks, and vice versa. At the end of this second period, a final blood sample will be collected.

The quantities of pecorino cheese chosen for intake are representative of the average consumption in Italy.

Eligibility Criteria:
Inclusion Criteria:

* 45-65 years of age
* BMI \< 27
* waist-to-hip ratio female\<0.85; male \< 0.98

Exclusion Criteria:

* metabolic diseases
* Physical activity of competitive nature
* Vegans and vegetarians
* Intolerances and allergies to the foods under study
Impact of GERD on Daily Life (NIS)

The aim of this study is to gather epidemiological data in a population of GERD patients in primary care with a history of erosive esophagitis (less than or equal to 3 years).


Eligibility Criteria:
Inclusion Criteria:

* Patients with erosive esophagitis (endoscopical findings according to the Los Angeles Classification; grade A-D) currently not treated with a proton pump inhibitor, for whom the general practitioner (GP) has decided to initiate or change the treatment for GERD
Acute Effect of Functional Crackers on Postprandial Metabolism

The aim of this interventional study was to investigate the postprandial effect of two types of functional crackers, with 10% grape seed flour or 40% barley flour, enriched with β-glucan, in metabolic biomarkers of healthy participants.

A pilot cross-over, controlled, randomized and single-blinded, intervention-clinical trial was carried out, in twelve healthy men and women, aged nineteen to sixty-five years, after random allocation into the control, the grape and the barley interventional groups, received a high-fat and high-carbohydrate meal, containing wheat flour or wheat and 10% grape seed flour or wheat and 40% barley flour, enriched with β-glucan, crackers. Participants consumed the same meals, allocating in cross-over order, with 1 washout week after each trial period. Differences on the metabolism of postprandial serum total, High Density Lipoprotein (HDL-), Low Density Lipoprotein (LDL-) cholesterol, glucose, triglycerides and uric acid levels, as well as of plasma total antioxidant capacity according to Ferric Reducing Antioxidant Power method, were determined between groups in fasting, thirty minutes, one and a half hour, and three hours after meal intake.

Eligibility Criteria:
Inclusion Criteria:

* Age 19-65 years

Exclusion Criteria:

* Age over 65 years old
* History of chronic illness including type I and II diabetes (hemoglobin A1c-HbA1c \> 5%)
* Abnormal Body Mass Index (BMI) (\>25 kg/m2)
* Alcohol overconsumption (\>40 g alcohol/day)
* Abnormal hematological and biochemical profiles (cholesterol \> 6.8 mM, triglycerides \> 2.8 mM, glucose \> 6.11 mM)
A Study to Determine the Absorption, Metabolism, and Excretion of [14C]-E6007 After a Single Oral Administration in Healthy Male Participants

This study will be conducted to evaluate the absorption, metabolism, and excretion of a single oral dose of \[14C\]-E6007 in healthy male participants.


Eligibility Criteria:
Inclusion Criteria:

* 30 to 55 years of age
* Body mass index between 18.5 and 30.0 kilograms per meters squared (kg/m\^2), and a total body weight between 50 and 100 kilograms (kg)
* In good health, determined by no clinically significant findings from medical history, physical examination, 12 lead electrocardiogram, vital sign measurements, and clinical laboratory evaluations
* Males will agree to use contraception
* Able to comprehend and willing to sign an informed consent form and to abide by the study restrictions

Exclusion Criteria:

* Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, haematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder
* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance
* History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy, and hernia repair will be allowed)
* Significant history or clinical manifestation of hemorrhoids
* History of alcoholism or drug/chemical abuse within 2 years prior to Check-in
* Positive hepatitis panel and/or positive human immunodeficiency virus test
* Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 90 days prior to Check-in
* Use or intend to use any prescription medications/products within 14 days prior to Check-in
* Participants in receipt of a live vaccine within 30 days prior to the first dose administration or who plan to receive a live vaccine during the study and for 14 days after the dose of study drug
* Use of tobacco or nicotine containing products within 3 months prior to Check-in
* Receipt of blood products within 2 months prior to Check-in
* Donation of blood from 3 months prior to Screening, plasma from 2 weeks prior to Screening, or platelets from 6 weeks prior to Screening
* Participants with exposure to significant diagnostic or therapeutic radiation or current employment in a job requiring radiation exposure monitoring within 12 months prior to Check-in
* Participants who have participated in any clinical trial involving a radiolabelled investigational product within 12 months prior to Check-in
Study of Insulin Pump Discontinuation in Adults With Diabetes

The purpose of this study is to determine the rate of insulin pump discontinuation 18 months after initiation in patients with diabetes, and to determine factors associated with this discontinuation.

Insulin pump discontinuation has been mostly studied in children and young adults living with diabetes, and rarely with a time-to-event analysis. We aim to evaluate the rate of insulin pump discontinuation after 18 months from initiation and factors associated with it in adults with diabetes.

Knowing these factors would allow better support for patients in difficulty.

Eligibility Criteria:
Inclusion Criteria:

All patients (adults and adolescents) with diabetes and an insulin pump initiation from 1 January 2015 to 30 June 2018 in the diabetes department of the Centre hospitalier sud francilien.

Exclusion Criteria:

* Pregnant women (or women planning pregnancy in the short term) with an insulin pump initiation from 1 January 2015 to 30 June 2018
* Patients hospitalized for an insulin pump replacement or change between 1 January 2015 and 30 June 2018.
* Patients with a history of insulin pump initiation within a period of less than 6 months before a new pump start between 1 January 2015 and 30 June 2018.