cyrilzakka/clinical-trials huggingface dataset:
The Effects of Lentil-containing Food Products on Satiety and Food Intake

The Lentil Satiety study will examine the effects of replacing wheat and rice with two types of lentils within food products (muffins and chilies) on satiety and food intake in healthy adults.

The Lentil Satiety study will examine the effects of replacing wheat and rice with two types of lentils (small green Eston and red split) within food products (muffins and chilies) on satiety and food intake in healthy adults, for a total of 6 study treatments. A total of 3 to 6 study visits (corresponding to consuming all muffins and/or all chilies) will take place where participants will consume one of the study treatments and subsequently complete satiety questionnaires over 180 minutes to measure satiety as subjective appetite sensations (hunger, fullness, desire to eat, and prospective food consumption). At 180 minutes, participants will receive ad libitum pizza and bottled water to consume until they are comfortably full for a measure of weighed food intake. At the end of each study visit, participants will be given a food scale and instructed to weigh and record all food and drink consumed for the remainder of the day for a measure of 24-hour energy intake.

Eligibility Criteria:
Inclusion Criteria:

* Healthy males and females
* Age 18 to 40 years old
* BMI 20-30 kg/m2

Exclusion Criteria:

* Blood pressure greater than 140/90 mmHg
* Major medical condition including a history of AIDS or hepatitis
* Medical or surgical event requiring hospitalization within 3 months of randomization
* Any medication use except stable dose (3 months) of oral contraceptives, blood pressure or statin medications
* Tobacco use
* Probiotic supplement use
* Dietary fibre supplement use
* Natural health products (NHPs) used for glycemic control (all other NHPs are ok, as long as stable for 3 months)
* Pulse consumption greater than 4 servings per week
* Food allergy or non-food life threatening allergy
* Pregnant or breastfeeding
* Alcohol consumption of greater than 14 drinks per week or greater than 4 drinks per sitting
* Recent or intended significant weight loss or gain (greater than 4kg in previous 3 months)
* Elite athletes
* Shift workers
* Breakfast skippers
* Score greater than 11, 9, or 8 on the Three Factor Eating Questionnaire (TFEQ) Cognitive Restraint, Disinhibition, and Hunger scales, respectively
* Dislike of frozen pizza
Tracking Response in Advance of Investigational Trials, Borderline Study

TRAIT-BOR is an open-label psychotherapy treatment study for adults who meet the diagnostic criteria for Borderline Personality Disorder (BPD) and are seeking enrollment in a clinical trial of a novel compound to treat BPD. The current study seeks to determine if there are therapeutic benefits to more infrequent, short term, or longer term supportive psychotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Participant has signed an ICF prior to any study-specific procedures being performed.
* Participant has a diagnosis of Borderline Personality Disorder, per DSM-5 criteria, as confirmed on the MINI, and ≥ 16 AAPI-CR total score.
* Participant is in good physical health, and, in the opinion of the investigator, is a suitable candidate for treatment with monthly supportive psychotherapy.
* Participant is 18 to 65 years old.
* For participants already receiving psychotherapy, including Dialectical Behavioral Therapy (DBT), they must continue their regular course of treatment for the duration of the current study.

Exclusion Criteria:

* Participant is pregnant, breast-feeding, or planning to become pregnant.
* A history or presence of a clinically significant hepatic, renal, gastrointestinal, cardiovascular, endocrine, respiratory, immunologic, hematologic, dermatologic, or neurologic abnormality, which in the opinion of the investigator may impact participant safety or study results.
* Participant has a history of any psychiatric condition other than BPD, which in the opinion of the investigator is primary, or any other psychiatric or neurologic disorder or symptom that could pose undue risk to the participant or compromise the study.
* Any participant who represents an acute suicidal risk in the opinion of the investigator, as defined by a "yes" response to suicidal ideation on questions 4 or 5, or answer "yes" to suicidal behavior questions on the CSSR-S within 90 days of screening.
* Any participant who represents an acute homicidal risk in the opinion of the investigator.
* Moderate or severe substance use disorder within 90 days prior to screen, according to DSM-5 criteria that in the opinion of the investigator could pose undue risk to the participant, or compromise the study.
* Any condition that, in the opinion of the investigator, makes the participant unsuitable for the study.
* Participants who require ongoing treatment with typical antipsychotics.
Pilot Study on the Evaluation of the Effectiveness of a Virtual Reality Device on Anxiety During Procedural Sedation in Traumatology in Emergency Department

The aim of this study is to evaluate the efficiency of a reality device and a virtual hypnosis software to reduce the anxiety during reduction procedure in traumatology in an emergency department. These devices have recently been evaluated in the management of pain and anxiety in different specialties but never in the context of analgesia-sedation protocols in emergencies.


Eligibility Criteria:
Inclusion Criteria:

* Patient aged 18 years or older
* Patient suffering from one of the following traumatic pathologies requiring a technical procedure in the emergency room Shoulder dislocation Ankle dislocation Elbow dislocation Wrist dislocation Reducible fractures
* No contraindication to Virtual Reality
* No contraindication to morphine, ketamine, propofol, paracetamol, nefopam and MEOPA
* Patient having given oral, free and informed consent

Exclusion Criteria:

* Patients suffering from mono or binocular blindness
* Patient under the influence of alcohol or psychotropic drugs
* Patient presenting a psychosis and/or a state of agitation, and/or a state of confusion.
* Patient presenting a hemodynamic, respiratory or neurological failure
* Patient with at least one of the following symptoms at the time of inclusion in the study: headache, dizziness, nausea, vomiting
* Persons benefiting from reinforced protection, i.e. minors, persons deprived of their liberty by a judicial or administrative decision, adults under legal protection (guardianship and trusteeship) and finally patients in a vital emergency situation.
* Pregnant or breastfeeding women, women of childbearing age who do not have effective contraception (hormonal/mechanical: per os, injectable, transcutaneous, implantable, intrauterine device, or surgical: tubal ligation, hysterectomy, total oophorectomy)
* Concurrent participation in another clinical research study whose objective is the evaluation of anxiety and/or pain
MEV to Block the Posterior and Lateral Cords of the Infraclavicular Brachial Plexus

The investigators have recently shown that LSIB in combination with a suprascapular and a cervical plexus block is a very good alternative for arthroscopic shoulder surgery. However, the investigators believe the total volume of local anesthetic for LSIB may be reduced. For shoulder surgery there is no need to block the medial cord and the investigators therefore hypothesize a significantly lower MEV95% by applying a selective lateral and posterior cord block

The MEV for a successful block in 50% of the participants will be determined by using the staircase up-and-down method introduced by Dixon and Massey. Logistic regression and probit transformation will be applied to estimate the MEV for a successful block in 95% of the participants.

Eligibility Criteria:
Inclusion Criteria:

* . Inclusion criteria are American Society of Anesthesiologists (ASA) physical status I-III, age between 18 and 70 years and body mass index (BMI) between 20 and 35 kg/m2.

Exclusion Criteria:

* Exclusion criteria are pregnancy, patients with contraindications to regional anesthesia, allergy to LAs, patients taking opioids regularly due to chronic pain, use of anticoagulation drugs other than acetylsalicylic acid or dipyridamole, atrioventricular block, diabetes.
Little Cigar and Cigarillo Warnings for Youth

This study explores the effect of the little cigars and cigarillos (LCC) warnings on youth who currently use, have ever used, or are susceptible to using LCCs. This study will inform the Food and Drug Administration (FDA) implementation of LCC warnings, which can reduce LCC use and lessen tobacco health disparities among youth.

Cigar use exposes youth to the addictive effects of nicotine during a critical developmental period and increases the risk of multiple cancers and premature death. Recent data indicate that cigars are the second most commonly used tobacco product by youth and that past 30-day cigar use is 7.6%, which translates into 1.1 million high school students. Of the three major types of cigars-large cigars, little cigars, and cigarillos-little cigars and cigarillos (LCCs) are the most commonly used in the US, particularly among younger people. LCC use also contributes to tobacco health disparities, as Black or African American youth use cigars more frequently than other youth. In 2016, the Food and Drug Administration (FDA) deemed LCCs subject to FDA regulation, requiring six rotating text-only warning statements to be on LCC packaging. Previous research has examined the effectiveness of LCC warnings in reducing youth willingness to use LCCs.

Research from studies of cigarette warnings suggests that effective LCC warnings should employ images that illustrate negative health effects associated with use and a larger warning label prominently displayed on the pack. Among youth, health warnings on cigarette packs that contain both text statements and images are more effective and engaging than text-only warnings. However, evidence for cigarette warning labels cannot adequately inform implementation of improved LCC warnings for three reasons: 1) there is no evidence on the effectiveness of the FDA-mandated text-only LCC warnings on behavioral intentions or other outcomes among youth 2)courts have ruled that effective tobacco warnings on one type of tobacco product cannot be used to justify warnings on other types of tobacco, and 3) LCC users have different demographic and consumption profiles than cigarette users include more Black/African Americans and use LCCs on fewer days per month.

Eligibility Criteria:
Inclusion Criteria:

1. Members of the recruitment panel (we are partnering with a panel provider for the recruitment of all participants)
2. Agree to provide their honest answers
3. Susceptible to using LCCs, or have ever used little cigars and/or cigarillos, or currently use little cigar and/or cigarillos in the past 30 days
4. Age 15 - 20 years old
5. Currently living in US or US territory
6. Able to complete 2 surveys that take approximately 15 minutes
7. Able to complete a 2-minute survey each day for 6 days
8. Able to verify they are not a bot using CAPTCHA
9. Able to answer a simple, random math question

Exclusion Criteria:

* Not able to verify they are not a bot using Completely Automated Public Turing test to tell Computers and Humans Apart (CAPTCHA).
* Not able to answer a simple, random math question.
A Trial of Tai Chi Intervention for Youngsters with Visual Impairments

Investigators conducted a single-blind, randomized trial of Taijiquan exercise as compared with a control intervention consisting of wellness education and jogging for youngsters with visual impairments. Sessions lasted 60 minutes each and took place three times a week for 12 weeks for each of the study groups. The primary end point was a change in the Brockport Physical Fitness Test (BPFT) at the end of 12 weeks. Secondary end points included summary scores of the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) and Pittsburgh Sleep Quality Index (PSQI)at the end of 12 weeks.

* Brockport Physical Fitness Test (BPFT) for youngsters with visual impairments, including 20-meter lap scores, Body mass index (BMI), Dominant Grip Strength, Curl-Up, Trunk lift, Back-Saver Sit-and-Reach and Shoulder Stretch.
* Basic information about visually impaired youth, including age, gender, height, weight.
* summary scores of the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36)
* summary scores of of the Medical Outcomes Study Pittsburgh Sleep Quality Index (PSQI)

Eligibility Criteria:
Inclusion Criteria:

* The age ranges from 10 to 17 years old, regardless of sex.
* had no previous experience as an athlete.
* could follow simple instructions.
* could walk without assistance.
* could maintain a regular lifestyle during the experiment.
* provided informed consent.

Exclusion Criteria:

* The exclusion criterion applied to those who suffered any severe illness or ailment which hinders mobility.
Computed Guided Prolotherapy Versus Conventional Prolotherapy

The aim of that study is to compare between conventional prolotherapy and computed guided prolotherapy in treatment of temporomandibular joint (TMJ) internal derangement.

This study will include patients with TMJ internal derangement with signs and symptoms of pain, clicking and limited mouth opening .The study will be held in oral and maxillofacial department, Faculty of Dental Medicine, Al-Azhar University, Assiut branch. Internal derangement of the joint will be confirmed by magnetic resonance image (MRI).

Patients included in this study will be divided randomly into two equal groups by the aid of financial coins. Group I: patients will be conventionally injected into the superior space of TMJ by injectable PRF by the aid of the surface facial landmarks where the patient will seated comfortably at 45° angle on the dental chair with the head turned toward the unaffected side. The target site will be prepared and disinfected with betadine. The points of needle insertion will be marked on the skin according to a line will be draw from the middle of the tragus of the ear to the outer canthus of the eye and entry points will be marked along this cantho-tragal line which will correspond to the glenoid fossa and will be marked 10 mm from the mid-tragus and 2 mm below the line.

Group II: patients will be injected into the superior space of TMJ with I- PRF by the aid of specific CT-planned 3D-printed surgical guide, which will lead the needle insertion, and the accuracy of the needle insertion into the superior space of the TMJ will be assessed.

Preparation of I-PRF:

The cubital area of the patient arm will be disinfected with betadine and the blood will be drawn from the patient cubital vein into plain tubes (vaccutainers) under aseptic conditions .The loaded tubes will be centrifuged at 750 rpm for 3 minutes and the I-PRF will be aspirated into a plastic syringe to be ready for injection into the superior space of the TMJ of patients of each group.

Eligibility Criteria:
Inclusion Criteria:

* Bilateral or unilateral TMJ internal derangement.
* No response to conservative treatments (soft diet, occlusal splint, muscle relaxants, non-steroidal anti-inflammatory drugs, or movement restriction).
* Ability to undergo MRI or CT scans without contraindications.

Exclusion Criteria:

* Those with systemic diseases (polyarthritis or rheumatoid diseases).
* Individuals with neurologic disorders.
* Patients with a history of condylar fracture or previous TMJ injections.
* Those with head and neck cancer.
* Completely edentulous patients (lacking teeth).
* Individuals with implanted metal or medical devices.
* Patients with developmental and congenital disorders of the TMJ.
Implementation of the Model of Modifiable Factors Specific to Problematic Internet Use in Adolescents

The study aimed to investigate the impact of a nursing care program based on the Model of Modifiable Factors Specific to Problematic Internet Use in Adolescents on adolescents' problematic internet use, self-regulation, family relationships, and coping levels.

This study constitutes a part of the doctoral thesis titled "Development of a Nursing Intervention Model Specific to Problematic Internet Use in Adolescents"

Eligibility Criteria:
Inclusion Criteria:

* Voluntarily agreeing to participate in the study,
* Being between the ages of 12-18,
* Receiving outpatient follow-up at the Child and Adolescent Mental Health Clinic,
* Having a Problematic Internet Use (PIU) issue (PIU is assessed according to the criteria by the doctors at the clinic. The doctors refer adolescents who meet the criteria. These criteria are as follows: a) using the internet for longer than planned, b) experiencing withdrawal symptoms when unable to access the internet, c) failing to control internet usage, d) being excessively preoccupied with the internet, e) losing interest in offline hobbies, f) a desire to use the internet more, g) continuing excessive internet use despite knowing it negatively affects their life, h) using the internet to escape problems, i) lying about internet use).

Exclusion Criteria:

* Having a speech, hearing, or self-expression impairment,
* Having received or currently receiving professional support related to PIU.
LifeZig Personalized Reminiscence Video With Slideshows and Music for Individuals With Alzheimer's and Dementia

The LifeZig Project is a research study of a new reminiscence activity for individuals with Alzheimer's Disease (AD) and other types of dementia, based on the LifeZig system, with personalized video channels containing old photographs and music on television.

The goal of the LifeZig study is to enhance the quality of life for dementia patients and their families/caregivers, decrease the burden of care, and contribute to positive interaction between dementia patients and families/caregivers.

This program creates personalized TV channels with old photographs of AD patients, music, narration and relaxing sounds; as an activity to relax dementia patients.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria for dementia patients:

  * documented diagnosis of probable Alzheimer's or other type of dementia, medically stable, and visual/hearing capabilities to watch television.
* Inclusion criteria for family members/caregivers:

  * provide care or be a family member of dementia patient, have knowledge of the person, and be able to provide old photographs of dementia patient.
Comparative Evaluation of Pharmacokinetics and Safety of BCD-055 and Remicade in Patients With Ankylosing Spondylitis

ASART-1 clinical study is a phase 1 study which carried out to establish the pharmacokinetic equivalence and equal safety profile of BCD-055 (infliximab manufactured by JSC BIOCAD, Russia) and Remicade when used as multiple IV infusions for the treatment of ankylosing spondylitis.

ASART-1 study is the first step of clinical evaluation of infliximab biosimilar manufactured by JSC BIOCAD, Russia.The aim of this study is to establish that BCD-055 is equivalent to Remicade in terms of pharmacokinetics and safety when used by the standard regimen in patients with ankylosing spondylitis (AS).

The study will enroll 90 patients with active AS, who will be randomized into 2 groups (1:1 ratio): patients from the first group will receive BCD-055 IV at a dose 5 mg/kg on week 0, 2, 6, 14 and 22; patients from the second group will receive Remicade at the same regimen.

Eligibility Criteria:
Inclusion Criteria:

* signed informed consent
* active ankylosing spondylitis, which exists in patient within last 3 months
* BASDAI score \> or equal to 4 points, spinal pain (by VAS) \> or equal to 4 points
* history of NSAID use for the treatment of AS within last 3 months
* adequate renal and liver function
* absence of severe abnormalities in complete blood count
* consent to use adequate contraception
* ability to follow Protocol procedures

Exclusion Criteria:

* previously use of any biologic for AS treatment
* total ankylosing of the spine
* known allergy to chimeric proteins or any excipients of BCD-055/Remicade
* hepatitis B, active hepatitis C, HIV, syphilis
* known tuberculosis
* latent forms of tuberculosis
* any bacterial infection diagnosed within last month which required oral antibiotics (within last 2 weeks) or parenteral antibiotics (within last 4 weeks)
* drug or alcohol abuse
* any other disease which can affect assessments or masking some symptoms of AS (severe osteoarthrosis, nervous disorders with impairment of sensory or motor functions, another inflammatory joint disease apart from AS, etc.)
* severe uncontrolled hypertension
* chronic heart failure
* decompensated renal or liver disorders
* severe uncontrolled diabetes mellitus
* chronic obstructive lung disease, atopic bronchial asthma, angioedema in anamnesis
* any mental disorder, incl. severe depression or/and suicide thoughts/actions in anamnesis
* unstable angina pectoris
* myocardial infarction within last 12 months

Other exclusion criteria could be found in the Full Study Protocol
An Open-label, Non-controlled Study of KHK4827 in Subjects With Psoriasis

This study is an open-label, non-controlled study to evaluate the efficacy and safety of KHK4827 in subjects with pustular psoriasis (generalized) and psoriatic erythroderma. Pharmacokinetics of KHK4827 will also be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Subject has signed voluntarily the written informed consent form to participate in this study.
* Subject has been diagnosed as pustular psoriasis or psoriatic erythroderma.
* Subject has received at least one previous phototherapy or systemic psoriasis therapy or has been a candidate to receive phototherapy or systemic psoriasis therapy in the opinion of the investigator.

Exclusion Criteria:

* Subject with psoriatic erythroderma has involved Body surface area (BSA) of lesion \< 80% at baseline.
* Subject diagnosed with guttate psoriasis, medication-induced or medication-exacerbated psoriasis.
* Evidence of skin conditions at the time of the screening visit (eg, eczema) that would interfere with evaluations of the effect of KHK4827 on psoriasis.
* Subject has any active Common Terminology Criteria for Adverse Events (CTCAE) grade 2 or higher infection
* Subject has a significant concurrent medical condition or laboratory abnormalities, as defined in the study protocol.
* Subject has used Ultra Violet B (UVB) therapy within 14 days of the first dose or Ultra Violet A (UVA) (with or without psoralen) within 28 days of the first dose.
* Subject has used etanercept, adalimumab, infliximab or ustekinumab within 1 week, 2 weeks, 8 weeks or 12 weeks of the first dose, respectively.
* Subject has stopped ustekinumab or other anti-Interleukin (IL)-23 biologics therapy due to lack of efficacy
* Subject has used live vaccine within 3 months of the first dose
* Subject has previously used an anti-IL-17 biologic therapy