cyrilzakka/clinical-trials huggingface dataset:
Study of Azeliragon in Patients With Mild Alzheimer's Disease and Impaired Glucose Tolerance

This is a study to evaluate the efficacy and safety of azeliragon in patients with mild Alzheimer's disease and impaired glucose tolerance. Patients will receive either azeliragon or placebo with a patient's participation lasting approximately 9 months (in Part 1) or 21 months (in Part 2).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of probable Alzheimer Disease (AD) with documented evidence of progression of disease
* Mini Mental State Examination (MMSE) score of 21-26, inclusive
* Clinical Dementia Rating global score of 0.5 or 1
* Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog14) of 10 or more
* Brain magnetic resonance imaging (MRI) consistent with the diagnosis of probable AD
* Concurrent use of cholinesterase inhibitor or memantine with stable dose for at least 2 months prior to screening
* Hemoglobin A1c (HbA1c) 6.5% - 9.5%, inclusive
* Caregiver willing to participate and be able to attend clinic visits with patient
* Ability to ingest oral medications

Exclusion Criteria:

* Significant neurological or psychiatric disease other than Alzheimer's disease
* Previous clinical trial participation within 90 days of screening
* Previous exposure to putative disease modifying therapy for Alzheimer's disease within 1 year of screening
* History of cancer within the last 5 years except adequately treated cervical carcinoma in-situ, cutaneous basal cell or squamous cell cancer, or non-progressive prostate cancer not requiring current treatment
* Women of childbearing potential
* Uncontrolled blood pressure and/or blood pressure above 140/90
* Participants receiving medications that may negatively impact cognitive function
* History of diabetic ketoacidosis within the past year
* History of chronic pancreatitis
* Stage 4 kidney disease
* Use of insulin therapy
Wise Interventions in the Digital Society

This study evaluates the effectiveness of a Wise intervention based on self-affirmation (SA) and Implicit Theories of Personality (ITP) in Spanish adolescents and young people. Half of participants will receive the ITP and self-affirmation intervention, while the other half will receive a control intervention.

Adolescence is a period that involves important transitions and learning opportunities. Adolescents and young people learn and develop new competencies and facets in the digital society. Hence, a large part of their social relationships takes place through social media.This offers them numerous positive opportunities for the emotional and social development of adolescents and young people. They can develop positive interactions through prosocial behaviors, empathy, and social support towards others. At the same time it is not without potential risks, especially in adolescence, a stage of psychological vulnerability for risky behaviors. Very recently, interest in scientific social psychology has grown due to a new approach to interventions, which have been called "wise interventions." This approach involves a set of rigorous techniques, based on theory and research, that address specific psychological processes to help people thrive in various life environments. The main objective of this project is to design and evaluate the effectiveness of a wise intervention based on self-affirmation (SA) and Implicit Theories of Personality (ITP) to promote various online prosocial behaviors (help, empathy, collaboration) and prevent online risk and harassment behaviors (online bullying, sexting, grooming). Secondary objectives are (1) to assess the moderating role of gender and the degree of evolutionary development of adolescents and young people, and (2) to evaluate potential mediating mechanisms for the effectiveness of the interventions. The study will involve the evaluation of the intervention in a sample of around 1000 young and adolescents randomly allocated to experimental and control condition.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent by the adolescents and their parents.
* To be fluent in Spanish and/or Euskera.

Exclusion Criteria:

* Lack of permission by parents and the adolescent.
* Lack of understanding of the instructions.
Prospective Observational Study of Pain Evolution in Patients With Primary Knee Osteoarthritis Treated With Pronolis® HD

Prospective observational study of 6 months of follow-up, of national and multicenter scope with medical device with CE marking and according to the usual clinical practice.

In addition, due to the observational design of the clinical investigation, no assignment of the patients will be made to any specific study group, but will be carried out in accordance with the usual clinical practice, not applying any intervention other than the usual one in this type of care practice and always in accordance with current clinical guidelines and recommendations and with the indications authorized in Spain.

Patients will be recruited by specialists and will be followed for 6 months under the conditions of usual clinical practice.


Eligibility Criteria:
Inclusion Criteria:

1. Patients of both sexes and over 18 years.
2. Patients with a previous diagnosis of primary knee osteoarthritis according to ACR criteria and who have a knee x-ray performed during the previous 18 months.
3. Patients who attend a control clinic for primary osteoarthritis of symptomatic knee.
4. Patients with pain equal to or greater than 4 on the VAS scale.
5. Patients who have been prescribed an injection of Pronolis® HD as part of the usual clinical practice.
6. Patients who have given their written informed consent to participate in the clinical investigation.
7. Patients for whom there is a reasonable expectation of follow-up during the development of clinical research.
8. Patients who understand and can complete the questionnaires and do not have cognitive impairment that prevents it.

Exclusion Criteria:

1. Patients with known intolerance to hyaluronic acid.
2. Patients with hypersensitivity to intraarticular injections.
3. Patients who present with infection in the knee joint.
4. Patients presenting with a skin disorder or infection in the area of injection or systemic.
5. Coagulation disorders that contraindicate puncture.
6. Patients who have been prescribed intra-articular injection in both knees.
7. Patients diagnosed with autoimmune rheumatologic diseases or connective diseases.
8. Patients diagnosed with microcrystalline diseases.
9. Patients with traumatic history in the study joint.
10. Patients with a surgical history in the study joint.
11. Pregnant or breastfeeding women.
Effect of Gluten-free Diets on Anthropometric and Dietary Data of Healthy Eutrophic Women

The objective is to evaluate, in healthy, eutrophic women, if gluten intake influences on body weight, basal metabolic rate and macronutrient intake. In a crossover double masked model, 30 volunteers will be randomized into two groups, half of them will initiate the experiment by taking 2 "placebo" muffins daily for 3 weeks (Placebo phase) and the remnant volunteers will take 2 "gluten" muffins for 3 weeks (Gluten phase). After one day of wash out, the volunteers will be transferred for the other phase to complete 3 more experimental weeks.

The objective is to evaluate in eutrophic women the impact of intake of moderate amounts of wheat gluten on body weight basal metabolic rate and possible relation to macronutrient intake. For this, 30 volunteers will kept on a restricted diet in gluten-free foods of 6 weeks. At the first moment, a structured Food Frequency Questionnaire will be applied, as well as a 24-hour food register, to evaluate the average food and gluten daily intake. The volunteers will be randomized into two groups, half of them will initiate the experiment by taking 2 placebo muffins daily for 3 weeks (Placebo phase) and the remnant volunteers will take 2 gluten muffins for 3 weeks (Gluten phase). After one day of wash out, the volunteers will be transferred for the other phase to complete 3 more experimental weeks. During these 6 experimental weeks, all volunteers will be instructed to exclude any food containing gluten from their diet. The test food (gluten and placebo muffins) will be produced in the Laboratory of Dietetic Technique of the School of Nursing of the Federal University of Minas Gerais and delivered weekly to each volunteer. Placebo test foods is a corn-based muffin of about 45g. In the Gluten muffins, 10g of corn is replaced by 10g of gluten (corresponding to 7.5g of gluten protein). Each volunteer will be instructed to take 2 (placebo or gluten) muffin/day. To evaluate diet adherence and signs and symptoms of intolerances, volunteers will fill a questionnaire weekly, informing about the consumption of the test food, eventual intake of food containing gluten, and the presence of gastrointestinal signs and symptoms such as constipation, diarrhea, nausea or vomiting etc.

Eligibility Criteria:
Inclusion Criteria:

* Women aged between 18 and 40
* Body Mass Index (BMI) between 18.5 and 24.9 kg / m²
* Sign of informed consent
* Absence of associated chronic diseases

Exclusion Criteria:

* Postmenopausal patients
* Onset of chronic medication
* discontinuance of test food intake for 2or more days
* Do not attend 2 of the 3 meetings.
Pilot Study of Secondary Causes of Osteopenia/Osteoporosis in Adults With Breast and Prostate Cancer

The investigators hypothesis is that secondary causes of bone loss are prevalent in patients with breast and prostate cancer, and those patients with secondary causes of bone loss are at higher risk for treatment related bone loss. The goals of this pilot study are to estimate the prevalence of secondary causes of osteoporosis in a cohort of patients with nonmetastatic breast and prostate cancer with osteopenia and osteoporosis.

The interaction of aging, cancer, and bone loss is poorly understood. Cancer or cancer therapy could potentially accelerate bone loss and increase the risk for osteopenia or osteoporosis. The hypothesis of this observational study is that secondary causes of bone loss are prevalent in patients with breast and prostate cancer who are high risk for treatment related bone loss. In order to test this hypothesis, this prospective pilot study will systematically evaluate secondary causes of bone loss in a cohort of patients with nonmetastatic breast and prostate cancer with osteopenia/osteoporosis.

1. Identify patients with nonmetastatic breast cancer newly diagnosed with osteopenia/osteoporosis (Dual Energy X-ray Absorptiometry Bone Density scan T-score average between hip (femoral neck) and spine (L1-L4) of less than -1.0 to -2.5/ less than -2.5, respectively).
2. Identify patients with nonmetastatic prostate cancer newly diagnosed with osteopenia/osteoporosis (Dual Energy X-ray Absorptiometry Bone Density scan T-score average between hip (femoral neck) and spine (L1-L4) of less than -1.0 to -2.5/ less than -2.5, respectively).
3. Refer patient to City of Hope Endocrinology Osteoporosis Clinic.
4. Approach patient in consecutive order in which they have been referred to Endocrinology Osteoporosis Clinic.
5. Describe the study to the patient: patient consents or refuses.
6. Once consented, the patient's medical records are reviewed and Dual Energy X-ray Absorptiometry Bone Density reports are obtained from City of Hope records or the screening medical institution records to confirm diagnosis of osteopenia/osteoporosis or normal bone health.
7. Study participants will undergo an evaluation for secondary causes of bone per standard of care with patient questionnaires.
8. Furthermore, laboratory tests that support secondary causes of bone loss will be retrospectively collected via chart review.

Eligibility Criteria:
Inclusion Criteria

1. Diagnosis of nonmetastatic breast cancer or diagnosis of nonmetastatic prostate cancer
2. Measurement of bone mineral density by Dual Energy X-ray Absorptiometry (DEXA) within 6 months of enrollment into study.
3. Patients of all ages are eligible but need to qualify for standard DEXA screening
4. Patients of all performance status are eligible
5. Patients are able to give informed consent

Exclusion Criteria

1. Patients previously diagnosed or treated for osteoporosis/osteopenia
2. Stage IV cancer
High Fat Diet II on Weight Loss

To evaluate two different diets and their effects on weight loss and measurements of several risk factors for cardiovascular disease. One diet will be a high saturated fat diet (HSFD) and the other is a low saturated fat diet (LSFD) that limits fat but especially saturated fat as red meat. All participants in this study must eat both diets as this is a randomized cross-over design.


Eligibility Criteria:
Inclusion Criteria:

In order to qualify, participants must have metabolic syndrome:

* triglycerides greater than 150 mg/dL
* blood pressure greater than 130 mmHg and/or diastolic blood pressure greater than 85 mmHg
* fasting glucose greater than 110 mg/dL
* waist circumference greater than 40 inches in men or 35 inches in women
* reduced HDL less than 40 mg/dL in men and less than 50 mg/dL in women. Participants must be capable of performing symptom-limited maximal exercise capacity study. Blood and urine samples collected at baseline will be analyzed for CBC, serum glucose and electrolytes, hepatic panel and TSH.

Exclusion Criteria:

Participants will be excluded for any significant blood dyscrasia, fasting glucose greater than 200 mg/dL, creatine greater than 2 mg/dL, any significant electrolyte disorder, hepatic functions greater than two times normal or abnormal TSH.
Healthy Eating for Successful Living in Older Adults Program (HE) Study

The Healthy Eating for Successful Living in Older Adults™ (HESL) is a six-week community nutrition and lifestyle education program designed specifically for the elderly (\>60 years), to promote dietary and behavioral changes towards a healthy lifestyle. The intervention was evaluated using a randomized-controlled trial.

The elderly are at a higher risk of various chronic diseases. The burden of various chronic diseases such as heart disease and osteoporosis can be reduced with change in dietary and other lifestyle behaviors. The Healthy Eating for Successful Living in Older Adults™ (HESL) provides elderly with needed knowledge on healthy food choices and lifestyle behaviors, and tools that support behavioral changes. The investigators aimed to evaluate this intervention program by determining, among others, the impact of the intervention on factors such as dietary intake of fiber, and other nutrients, as well as healthy behaviors and food choices, and quality of life at 6 months post-intervention, using a randomized-controlled trial. The intervention group was compared to the control group receiving no intervention to evaluate the effects of the six-week HESL intervention on our outcome measures of interest.

Eligibility Criteria:
Inclusion Criteria:

* willingness to participate and complete all study activities following randomization into the intervention or control group.
* English-speaking.
* interested and able to participate.

Exclusion Criteria:

* None
The Effect of the Inclusion of Soybean Flour on Glycemic Responses

Foods that release glucose rapidly, leading to spikes in blood sugar and insulin (known as high glycemic index foods), generate lower satiety responses than foods with low glycemic index. High glycemic index foods are also linked to an increased risk of developing diabetes. The partial replacement of carbohydrates in rich staple foods with soy flour has the potential to reduce glycemic response and improve satiety.

In many regions of Latin America, as well as in the Middle East and North Africa (MENA) regions, bread is the staple source of calories, but it is a relatively poor source of balanced nutrition. Bread enriched with soy flour could provide higher dietary protein while moderating blood glucose (and insulin) spikes, which can help reduce insulin resistance and metabolic diseases. The results of this study could provide government and private human nutritionists with the evidence they need to formulate soy flour into bread, corn tortillas, and arepas for schools and homes.

The purpose of this study is to compare different percentages of soy flour inclusion rates in recipes of bread, flour tortilla, and arepa (South American corn pancake) for its effect on satiation and glycemic and insulin responses.

The hypothesis to be tested is that soy flour inclusion will improve the protein content, satiety profile and glycemic response of the products without significant increases in insulin responses (compared to the same products prepared with regular wheat flour).

Eligibility Criteria:
Inclusion Criteria:

* Male and female between 21-45 years of age
* All races/ethnicities
* Body mass Index (BMI) \> 25 kg/m2 and \<40 kg/m2 (i.e., overweight and obesity, excluding severe obesity)
* Fat %: \> 30% for female or \> 20% for male

Exclusion Criteria:

* Currently smokes or quit smoking nicotine cigarettes, vapes or E-cigarettes for less than 6 months ago
* Pregnant, breastfeeding, menopausal
* Hemoglobin: \<11g/dl for female and \<13g/dl for male
* Blood donation in the past 8 weeks
* Gluten intolerance (Gluten allergy, wheat allergy, celiac disease), Soy intolerance or allergy
* Presence of malabsorption syndrome
* History of bariatric surgery
* Presence of inflammatory intestinal disease, liver, or kidney disease
* Diabetes (fasting glucose level \>126mg/dl or plasma glucose level 2h after glucose challenge \>200 mg/dl) or taking medicines to treat diabetes
* Polycystic ovary syndrome (pcos)
* Untreated hypertension
* Taking any medication that might affect glucose metabolism or the results of our study
* History of cancer \<5 years ago
* Abnormalities in the metabolic panel test (e.g., liver enzymes \>2 times the upper limit).
* Seizures
Evaluation of a New Self-assessed, Home-based Symptom Score in Cat Allergic Patients

In the last decades the prevalence of allergies has reached epidemic proportions. 10 to 15% of the population suffers from cat allergy. Investigators perform this study in order to further investigate symptom records and their evaluation in cat allergic patients.

Investigators primarily aim to better standardize the symptom recording of cat allergic persons under real-life conditions and to evaluate the effect of hypoallergenic cats on symptom strength.


Eligibility Criteria:
Inclusion Criteria:

* Participant understands the nature, meaning and scope of the study.
* Signed Informed Consent after being informed.
* Male and Female patients 18 years to 65 years of age.
* Positive screening prick test (mean wheal diameter equal or greater 3 mm) when tested with already standardized cat allergen extract.
* Positive screening prick test (wheal diameter equal or greater 3mm) to Histamine dihydrochloride 10 mg/ml.
* Positive Scratch Test when tested with cat dander sample of participant's cat.
* Baseline symptoms with a severity of "1" in at least 2 different symptoms.
* Owner of a cat that lives in the same household.
* Cat will not have been washed in the 4 weeks before starting the test phase.

Exclusion Criteria:

* Impaired in understanding the nature, meaning and scope of the study or incapable of giving written informed consent
* Participation in another study with investigational drug within the 30 days preceding and during the present study
* Women who are pregnant or breast feeding
* Intention to become pregnant during the course of the study
* Positive skin reaction in the prick test to negative control
* History of anaphylactic reaction to pet allergens
* Severe diseases influencing the results of the present study by discretion of the investigator
* Immunotherapy with fel d 1 / cat allergen preparation during the past two years
* Skin lesions and excessive hair-growth in the skin test areas
* Treatment with prohibited concomitant medications according to section 8.3 with the exception of medications with local effects which will not influence the results of the skin tests and the results of the other tests (testing period).
* The patient should not suffer from other respiratory allergies during this study
Validation of Actigraph Measured Sleep During Acute Diverticulitis

The purpose of this study is to investigate the accuracy of actigraph measured sleep compared to the golden standard (polysomnography) during Acute uncomplicated diverticulitis. Our hypothesis is the actigraph is accurate for sleep-monitoring for this group of patients

The actigraph has been proven to measured sleep data with an accuracy about 80% (compared with Polysomnography) in patients who have undergone surgery.

But this accuracy has not been validated in relation to none surgical inflammatory diseases. This study will investigate the accuracy of actigraph measured sleep in diverticulitis patients.

Following methods will be applied

Device: Wrist-Actigraph - Octagonal Basic Motionlogger, Ambulatory monitoring Inc, New York, USA

Other: Sleep-diary

Device: Polysomnograph - Embla Titanium (Natus Medical Incorporated, USA)

Eligibility Criteria:
Inclusion Criteria:

* CT-verified diverticulitis patients managed by antibiotic treatment at Herlev Hospital
* Pain and fever occurred less than 72 hours prior to the admission
* ASA (American Society of Anesthesiologists) score I to III

Exclusion Criteria:

* Surgical intervention needed
* Complicated diverticulitis
* Complications in relation to diverticulitis
* Pain and fever occurred more than 72 hours prior to the admission
* In anticoagulant treatment and heart rate control treatment
* Known Autoimmune disease
* Known medically treated sleep-disorder (insomnia, restless legs etc.) and sleep apnea
* Shift-work or jetlag
* Daily use of opioid, psychopharmaca, opioids or anxiolytics (including Hypnotics)
* Known psychiatry conditions in treatment with psychopharmaca
* Daily alcohol intake of more than 5 units or drug abuse
* Missing written consent
* Diabetes Mellitus
* Predicted bad compliance
* Pregnant or breast-feeding
* Urine or fecal incontinence
* Severe kidney disease
* Current cancer
New Multiplex Real-time PCR for Genital Ulcer Disease

(i) To compare a new diagnostic PCR with established diagnostic procedures for T. pallidum (serology, dark field microscopy), H. ducreyi (cultivation), HSV types 1 and 2 (cultivation, PCR).

(ii) To assess the frequency of infections with T. pallidum, H. ducreyi and HSV types 1 and 2 in patients with genital, anal and oropharyngeal ulcers by a new PCR.


Eligibility Criteria:
Inclusion criteria:

* Patient with genital, anal or oropharyngeal ulcers
* Age minimum of 18 years.
* Informed consent must be obtained from each patient/control patient in written form prior to any study procedure.

Exclusion criteria:

* Antibiotic therapy within 2 weeks before the visit
Effectiveness of School-based Health and Nutrition Education to Improve Health and Dietary Practices of Primary School Children From Jimma Zone

School based Health and Nutrition Education (SHNE) is a key component of school health and nutrition programs that can address several health and nutrition issues in Ethiopia.


Eligibility Criteria:
Inclusion Criteria:

* Grade 5 to 8

Exclusion Criteria:

* Mental Problem
* Has no Family