cyrilzakka/clinical-trials huggingface dataset:
Combined Effects of Variety and Portion Size on Meal Intake of Women

The primary purpose of this study is to investigate the combined effects of meal variety and portion size on food intake at a meal. The study will also investigate relationships with eating microstructure such as eating rate and bite size. Additionally, other individual characteristics will be examined for their influence on the effects of variety and portion size on meal intake.


Eligibility Criteria:
Inclusion Criteria:

* Be willing and able to travel to Penn State University Park campus weekly for meals
* Be fully vaccinated against COVID-19
* Be a woman 20 - 65 years old
* Regularly eat 3 meals/day
* Be willing to refrain from drinking alcohol the day before and during test days
* Have a body mass index between 18.0 and 35.0 kg/m\*m
* Be willing to refrain from eating after 10 pm the evening before test sessions
* Be willing to participate in all study procedures

Exclusion Criteria:

* Must not be a smoker
* Must not be an athlete in training
* Must not be pregnant or breastfeeding at the time of screening
* Must not have taken prescription or non-prescription drugs that may affect appetite or food intake within the last 3 months
* Must not dislike or be unable to eat the test foods (because of allergies, intolerance, or dietary restrictions)
* Must not have a high variability in liking of the test foods
* Must not be currently dieting to gain or lose weight
* Must not have a health condition that affects appetite
* Must not have participated in a similar study in our lab in the past year
* Must not be a student, faculty, or staff member in nutritional sciences or psychology
Live Kidney Donor Study -Renal Function Study

Kidney transplantation from living donors has been shown to carry many benefits over deceased donor transplantation. Because of benefits such as shorter waiting times and improved outcome for transplant recipients, living kidney donation accounts for an increasing number of kidney transplants nationwide. Most published studies about living kidney donation demonstrate that the procedure is safe, but they also emphasize concerns that long-term data on live donor outcomes are insufficient. In particular, data concerning the extent of renal function decline after donation are inadequate. This study will measure glomerular filtration rate (GFR) in previous living donors and aims to more accurately describe renal function after kidney donation.

Previous studies poorly describe renal function after kidney donation. Most published studies of renal function after donation are based on predictive equations, which were not designed for living kidney donors. One concern is that use of these equations may underestimate glomerular filtration rate (GFR) following donation. Systematic underestimation of GFR may cause previous kidney donors to be inaccurately categorized as having chronic kidney disease (CKD).

While data for the entire kidney donor population are insufficient, there is even less available information about renal function after donation in black renal donors. In the general population, the incidence of end stage renal disease is higher among blacks compared to whites. Whether this pattern carries over to the black renal donor population is unclear.

The primary objectives of this study are to more accurately measure current GFR; evaluate the change in GFR before and after donation; compare measured GFR in donors matched by race, age, sex, time from donation, presence of hypertension, and presence of obesity; and evaluate differences between predictive equations and measured GFR.

This is an observational study to look at the long term outcomes in living kidney donors. Participants in this study will also be participants in DAIT RELIVE-04. As a part of this study, participants will have a brief medical history taken and a glomerular filtration rate test performed.

Eligibility Criteria:
Inclusion Criteria:

* Underwent unilateral donor nephrectomy between 5 and 50 years ago; but no later than June 30, 2005 at Mayo Clinic or University of Minnesota
* Alive at the time of study recruitment
* Underwent GFR measurement before and early after donor nephrectomy (Mayo Clinic participants only)
* Underwent GFR measurement late after donor nephrectomy and 3 or more years prior to the invitation to participate in this study (UMN participants only)
* Self reported black race (UAB participants only)
* Negative serum pregnancy test (Total Beta Human Chorionic Gonadotropin (HCG) \<5) for women of child-bearing potential

Exclusion Criteria:

* Less than 5 years out from time of kidney donation
* Inability to contact donor
* Inability or unwillingness to provide informed consent
* Iodine or iodinated contrast allergy.
* Pregnant or breast feeding women
VisiOn Restoration With FluidVisION Accommodating Intraocular Lens (AIOL)

The objective of this study is to obtain an initial assessment of the safety and performance of an investigational AIOL in patients undergoing cataract extraction and IOL implantation.

This study was originally designed as a single arm, unilateral study (one eye, one product only) to obtain an initial assessment of the safety and performance of an investigational IOL in subjects undergoing cataract extraction and IOL implantation. The study design was later modified to a contralateral study (both eyes, different product in each eye) to compare the safety and performance of the investigational IOL to a commercially available monofocal IOL.

Eligibility Criteria:
Key Inclusion Criteria:

* Corrected distance visual acuity (CDVA) worse than 20/40, or presence of visually significant lens opacity;
* Preoperative or predicted postoperative astigmatism of ≤ 1.0 diopter (D);
* Calculated IOL power within range.

Key Exclusion Criteria:

* Current medication that may affect accommodation;
* Systemic disease or concomitant medication that may increase operative risk or confound results;
* Ocular conditions that may predispose the subject for future complications;
* Monocular subjects or subjects with significant permanent visual function loss in fellow eye;
* Previous intraocular or corneal surgery in either eye that may confound the results or increase the risk to the subject, including implantation of a multifocal IOL or other presbyopic corrective surgery in the fellow eye;
* Grade 4 cataract of any type.
Antioxidant-rich Diet and Oxidative Stress in Healthy Preschoolers

Uncontrolled and prolonged oxidative stress plays an important role in the onset and progression of cardiovascular disease, hyperlipidemia, diabetes, and various cancers. Given that many diseases can start as early as childhood, eating patterns in childhood and preventing oxidative damage can have beneficial long-term health effects. Antioxidant-rich foods can slow down the progression of chronic diseases.

In Slovenian kindergartens (and schools) children consume up to 70% of their daily energy and nutritional needs, so what is offered to them is very important. This study will evaluate the hypothesis that providing an antioxidant-rich diet in kindergartens can result in the reduction of biomarkers of oxidative stress.


Eligibility Criteria:
Inclusion Criteria:

* • Healthy children aged 5-6 who will attend the compulsory medical examination before entering primary school

Exclusion Criteria:

* • Children with chronic conditions (e.g. diabetes, asthma)

  * Children with allergies to food (e.g. gluten, egg, milk, lactose intolerance)
Prospective, Longitudinal Natural History Study in Dystrophic Epidermolysis Bullosa

The objective of this study is to characterize the extent and severity of disease in subjects with DEB and the progression of disease over a timeframe relevant to interventional studies. The data from this study will be used to inform the study design and address statistical considerations of future treatment protocols.

This is a prospective, multicenter, multinational, longitudinal assessment of disease severity in subjects with DEB. Subjects with either dominant or recessive DEB (dominant dystrophic epidermolysis bullosa (DDEB) and recessive dystrophic epidermolysis bullosa (RDEB), respectively) will be assessed four times over a one year period: upon enrollment, and at 1 to 2 weeks and 6 and 12 months after enrollment. All subjects with either DDEB or RDEB that meet the study entry criteria will be offered participation in the study, provided they can be accommodated within the anticipated study timeline. In addition to their usual clinic assessment, subjects will have a quantitative evaluation of skin involvement and will be asked to fill out questionnaires that measure among other things disease severity, QOL, pain, pruritus, and medical and family histories.

Eligibility Criteria:
Eligibility Criteria

* Subjects of any age (newborns included) may participate
* Subjects over 18 years of age and parent(s)/legal guardian(s) of subjects \<18 years of age must provide written informed consent prior to participating in the study and informed assent will be obtained from minors at least 7 years of age
* Subjects must have a documented diagnosis of DEB based on clinical presentation and either skin biopsy results showing an absence or reduction in C7 or anchoring fibrils or genetic analysis showing a mutation in collagen, type VII, alpha 1 (Col7A1); alternatively, subjects must have a clinical diagnosis of DEB and a documented diagnosis of DEB (as above) in a first degree relative
* No experimental systemic therapy for DEB including, but not limited to, bone marrow transplantation, systemic immune suppression, or experimental therapies that involve live cells which have the potential for systemic spread such as gene transfer, stem cell infusions or other cell type injections
The Effect of Active Breathing Exercises in Stroke Patients With Respiratory Rhythm Disorder

The goal of this clinical trial is to explore The Effect of Active Breathing Exercises in Stroke Patients With Respiratory Rhythm Disorder. Patients will be randomly divided into an observation group and a control group, all receiving routine rehabilitation treatment. On this basis, the observation group will be given Active Breathing Exercises. Researchers will compare dysphagia of two groups.

A growing body of literature indicates the existence of a highly stable, coordinative relation between respiration and oropharyngeal swallowing in healthy adults. The goal of this clinical trial is to explore The Effect of Active Breathing Exercises in Stroke Patients With Respiratory Rhythm Disorder. Patients will be randomly divided into an observation group and a control group, all receiving routine rehabilitation treatment. On this basis, the observation group will be given Active Breathing Exercises. Researchers will compare dysphagia of two groups.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed with Respiratory Rhythm Disorder
* age ≥ 18 years;
* meeting the diagnostic criteria of stroke;
* any degree of dysphagia at admission;
* steady vital signs, without severe cognitive impairment or sensory aphasia, able to cooperate with the assessment.
* transferred out within three weeks of hospitalization in the neurology department.

Exclusion Criteria:

* complicated with other neurological diseases;
* tracheostomy tube plugged;
* unfeasible to the support of parenteral nutrition;
* simultaneously suffering from liver, kidney failure, tumors, or hematological diseases.
Strengthening Health and Insight in New Educators

Teachers are at notable risk for depression and anxiety. The present study tests an app-based mindfulness intervention for teachers in their final year of training with the goal of preventing the deterioration of their mental health during the transition into the classroom. The project will strengthen the research environment at the University of Alabama and will involve undergraduate research assistants in each step of the research process.

Mental health concerns in teachers have escalated since the onset of the pandemic, and the deterioration of mental health can begin as early as the teacher training period. Accessible and scalable programs that prepare teachers for the stress of the profession are urgently needed to prevent the deterioration of mental health and its attendant consequences. The goal of this longitudinal project is to test the feasibility and acceptability, utility, and candidate mechanisms of an accessible, mobile health, mindfulness-based intervention, the Healthy Minds Program (HMP), to equip teachers in training ("pre-service teachers"; i.e., university students majoring in education) with skills necessary to maintain their mental health as they transition into the classroom. The project addresses three specific aims. Aim 1: a) Assess the feasibility and acceptability of the HMP for pre-service teachers and b) identify barriers and facilitators to program acceptability. Aim 2: Determine the utility of the HMP for preventing depression and anxiety (main outcomes) and turnover intentions (secondary outcome). Aim 3: Examine HMP effects on candidate mechanisms, and the effect of mechanisms on outcomes. The results of this project will provide critical insight into the potential for the HMP to scale up for widespread use in pre-service teacher training programs. Importantly, the project will provide a unique opportunity for undergraduate research at the University of Alabama, and will strengthen the research environment by involving undergraduate research assistants in each step of the research process.

Eligibility Criteria:
Inclusion Criteria:

* Students in Block 3 will be invited to participate in the study.

Exclusion Criteria:

* Students who are not in Block 3 will be excluded. Participants experiencing suicidal ideations at baseline and deemed via the clinical risk assessment procedure to be at moderate or high risk of suicide will be excluded from the study after baseline, and prior to randomization.
Effort to Narrow the Gap Between in Accordance With Guidelines and Consent to Treat CHB Population in East of China

China has the world's largest burden of hepatitis B virus (HBV) infection and will be a major contributor towards the global elimination of hepatitis B disease by 2030. One of the main issues in the management of patients with chronic HBV infection (CHB) is to maximize the individuals who need the treatment engaged and retained in care. However, our investigation revealed that 21.1% patients were treatment eligible but not treated based on Chinese 2019 CHB treatment guidelines, while only 213 (13.9%) patients were indicated-but-not-treated according to AASLD 2018 Hepatitis B guidance in a real-life cohort study. To maximize the individuals who need the treatment engaged and retained in care, integrated intervention strategies to address these treatment barriers are urgently needed. Therefore, we aim to propose a study to narrow the gap between in accordance with guidelines and consent to treat CHB population in EAST of China.


Eligibility Criteria:
Inclusion Criteria:

1. Positive HBV surface antigen (HBsAg) for 6 months or more;
2. Elevated ALT levels (\>1×ULN) and detectable HBV DNA;
3. Treatment-naïve;
4. Willing to attend this study and able to provide the written informed consent.

Exclusion Criteria:

1. Co-infection with other viral hepatitis and human immunodeficiency virus;
2. Concurrent with other chronic liver diseases, including primary biliary cirrhosis, autoimmune hepatitis, alcoholic hepatitis, nonalcoholic fatty hepatitis, and hereditary metabolic liver disease;
3. Patients with liver cirrhosis;
4. Coexistence of hepatocellular carcinoma and other malignant tumor;
5. Underwent liver transplantation before the enrollment;
6. Severe cardiac, renal, respiratory, hematological, or psychiatric illness.
Data Collection of Heart Rate and Blood Pressure

The purpose of the study is data collection for building and validating the algorithms for analytics of vital signs using wearable earphones (MindMics device).

MindMics is developing technology to enhance an individual's quality of life by continuously monitoring the heart rate, stress thereby allowing people to make better decisions regarding their health. MindMics has a working prototype of the ear buds which will perform all the conventional tasks earbuds do (listen to music, etc.), but, in addition, will measure your vital signs. The earbuds capture the sounds made by the various cardiac structures pulsing and moving blood.

Eligibility Criteria:
Inclusion Criteria:

* Ages 18-90
* No gender restrictions
* Cognitive ability to consent

Exclusion Criteria:

* Patients with pacemakers
* Patients with irregular heart rhythms
Moving on After Breast Cancer Plus- for Breast Cancer Survivors

Breast cancer (BC) ranks second among all the types of cancer and is equally common in developing as well as developed countries. Breast cancer is most common type of cancer worldwide and its diagnosis as well as early treatment is associated with distress. The aim of this study is to explore the feasibility of integrating a 'Moving on After Breast Cancer (ABC)' manual developed by service user (Dr A Saleem) with Cognitive Behavior Therapyfor Pakistani women who are breast cancer (BC) survivors attending primary care and oncology services in Pakistan B) refine the Moving on ABC plus so as to develop a culturally appropriate therapeutic programme to be tested in a future definitive randomized controlled trial.

According to an estimate of World Health Organization (2000) cancer was responsible for 12% of all the deaths from all causes worldwide and rate of cancer is expected to increase 50% by the year 2020. In Pakistan every ninth women has a chance of developing breast cancer, which is highest rate in Asia. The estimated incidence rate of breast cancer in Pakistan is 50/100,000. Despite the high association of distress with breast cancer, data on prevalence of depression in women with breast cancer especially in low income countries is limited .

The proposed project consists of two phases: 1) Phase 1: Integration of the two existing interventions Moving On ABC and the Cognitive Behavior Therapy and the refinement of the integrated intervention. 2) Phase 2: Randomized Control Trial (RCT). Sample size of Phase II will be comprised of 50 patients. Patients will be divided into two groups. One group will receive Group moving on ABC Plus intervention and other group will receive routine care. The total sample size of the effectiveness trial 354.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Breast cancer (stage I to stage IV)
* Has completed primary treatment for breast cancer
* Score of 10 or above on PHQ - 9 or GAD - 7
* Age 18 and above

Exclusion Criteria:

* Already diagnosed with any psychiatric illness
* Already taking psychiatric medicines
* Severe cognitive impairment (not able to give consent to take part in intervention)
Effects of a Hydroxyapatite-based Mouth Gel on Calcium Content of Plaque

The aim of this pilot study is to analyze if a hydroxyapatite-containing mouth gel has an influence on the calcium content of plaque.

\>= 20 subjects (7-11 years) use the hydroxyapatite-containing mouth gel for 3 days (3x per day); without using any other oral care product at this time. A dentist applies the gel on all teeth. At baseline and after 3 days plaque will be collected from buccal and labial surfaces (except surfaces with tartar). A "split-mouth" concept will be used:

Subjects in group A:

Baseline plaque collection: quadrant 1 and 4 Plaque collection after 3 days: quadrant 2 and 3

Subjects in group B:

Baseline plaque collection: quadrant 2 and 3 Plaque collection after 3 days: quadrant 1 and 4 (The time between last application of the gel and plaque collection will be 1 h) The plaque will be dried and afterwards the calcium content of the plaque will be quantitively analyzed by atomic absorption spectroscopy (AAS).

For all subjects: Calcium contents of plaque at baseline and after 3 days application will be compared by statistical methods.

Eligibility Criteria:
Inclusion Criteria:

* Girls and boys (7-11 years)
* Visible plaque
* \>= 4 teeth
* Good overall health

Exclusion Criteria:

* Allergic to one or more ingredients of the mouth gel
* Medication intake (e.g. antibiotics)
* Any other reason that, in the opinion of the investigator, disqualifies the subject from participating in the study
Study for Investigate the Pharmacokinetic Drug Interactions Between Gemigliptin and Rosuvastatin

Investigate the pharmacokinetic drug interactions between gemigliptin and rosuvastatin in healthy subjects


Eligibility Criteria:
Inclusion Criteria:

* Age between 20 to 45, healthy male subjects (at screening)
* BMI between 18 - 27 kg/m2 (at screening)
* Blood pressure SBP 90-140 mmHg, DBP 60-95 mmHg
* FPG 70-125mg/dL glucose level (at screening)
* Subject who totally understand the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the

Exclusion Criteria:

* Subject who has past or present history of any diseases following below.(liver including hepatitis virus carrier, kidney, Neurology,immunology,pulmonary,endocrine,hematooncology,cardiology,mental disorder.)
* Subject who had GI tract disease that influencable to drug absorption or(ulcer, acute or chronic pancreatitis) surgery.(appendectomy, hernioplasty are not included)
* Subject who had drug hypersensitivity reaction.(gemigliptin, rosuvastatin, aspirin, antibiotics)
* Subject who already admitted in other investigator product in 80 days
* Subject who had whole blood donation in 60 days, or component blood donation in 30 days or transfusion in 30 days currently
Visual Function Abnormalities in Strabismus and Amblyopia and Response to Therapy

Amblyopia and strabismus are characterized by a reduction in visual acuity, contrast sensitivity, grating acuity, vernier acuity, reading difficulties and binocular visual function deficits. Treated patients have residual visual function deficits. The purpose of the current study is to quantify various visual functions in amblyopic and strabismic participants at baseline, during and at the completion of treatment.

To examine the response of therapy on visual functions in amblyopic and strabismic participants.

The following visual functions will be measured prior to treatment. Eye movements, contrast sensitivity, grating acuity, visual acuity, vernier acuity, binocular visual functions, reading and visual scanning will be measured. The testing will comprise of one or more of the above paradigms depending on participant's cooperation and understanding as majority of the study participants will be children. The above measurements will be repeated during amblyopia therapy ( which comprises of glasses, patching and/or atropine eye drops) and at the completion of treatment. For participants with strabismus requiring strabismus surgery the measurements will be repeated after strabismus surgery.

Eligibility Criteria:
Inclusion Criteria:

* History of amblyopia or presence of amblyogenic risk factors.

Exclusion Criteria:

* History of neurologic disorders